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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-K

 

(Mark One)

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2018

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from             to             .

Commission file number: 001-37856

 

Medpace Holdings, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

32-0434904

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

5375 Medpace Way, Cincinnati, OH 45227

(Address of principal executive offices) (Zip Code)

(513) 579-9911

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Name of each exchange on which registered

Common Stock, par value $0.01 per share

 

Nasdaq Global Select Market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes      No    

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes      No    

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes     No    

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes      No    

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

Emerging growth company

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes      No    

The aggregate market value of the voting and nonvoting common equity held by nonaffiliates of the registrant, based upon the closing sale price as reported on the Nasdaq Global Select Market on June 30, 2018, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $635 million. For purposes of this computation, shares of the registrant’s common stock held by each executive officer, director, and each person known to the registrant to own 10% or more of the outstanding voting power have been excluded in that such persons are affiliates.

Indicate the number of shares outstanding of each of the issuer’s classes of Common Stock, as of the latest practicable date.

 

Class

 

Number of Shares Outstanding

Common Stock $0.01 par value

 

    35,688,784 shares outstanding as of February 22, 2019

 

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant's definitive proxy statement to be filed with the Securities and Exchange Commission relating to the 2019 Annual Meeting of Stockholders are incorporated herein by reference into Part III of this Annual Report on Form 10-K to the extent stated herein.

 

 

 


MEDPACE HOLDINGS, INC. AND SUBSIDIARIES

ANNUAL REPORT ON FORM 10-K

FOR FISCAL YEAR ENDED DECEMBER 31, 2018

TABLE OF CONTENTS

 

Item
Number

 

 

 

Page No.

 

 

 

 

 

 

 

PART I

 

6

1.

 

Business

 

6

1A.

 

Risk Factors

 

16

1B.

 

Unresolved Staff Comments

 

44

2.

 

Properties

 

45

3.

 

Legal Proceedings

 

45

4.

 

Mine Safety Disclosures

 

45

 

 

 

 

 

 

 

PART II

 

46

5.

 

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 

46

6.

 

Selected Financial Data

 

49

7.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

52

7A.

 

Quantitative and Qualitative Disclosures About Market Risk

 

69

8.

 

Financial Statements and Supplementary Data

 

70

9.

 

Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

 

112

9A.

 

Controls and Procedures

 

112

9B.

 

Other Information

 

113

 

 

 

 

 

 

 

PART III

 

114

10.

 

Directors, Executive Officers and Corporate Governance

 

114

11.

 

Executive Compensation

 

114

12.

 

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 

114

13.

 

Certain Relationships and Related Transactions, and Director Independence

 

114

14.

 

Principal Accountant Fees and Services

 

114

 

 

 

 

 

 

 

PART IV

 

115

15.

 

Exhibits, Financial Statement Schedules

 

115

16.

 

Form 10-K Summary

    

115

 

 

Exhibit Index

 

116

 

 

Signatures

 

118

 

- 2 -


FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts contained herein, including statements regarding our results of operations; financial position and performance; liquidity and our ability to fund our business operations and initiatives; capital expenditure and debt service obligations; business strategies, plans and goals, including those related to marketing, acquisitions and expansion of our business; product approvals and plans; industry trends; expectations regarding consumer behaviors and trends; our culture and operating philosophy; human resource management; arrangements with and delivery of our services to the customers; conversion of backlog; dividend policy; legal proceedings; and our objectives for future operations, are forward-looking statements. The words “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “see,” “will,” “would,” “target,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are based largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to inherent uncertainties, risks, changes in circumstances and other important factors that are difficult to predict. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all important factors on our business or the extent to which any factor, or combination of such factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed may not occur and our financial condition and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. We caution you therefore against relying on these forward-looking statements.  Some of the important factors that could cause actual results to differ from our expectations include regional, national, or global political, economic, business, competitive, market and regulatory conditions and the other important factors included in “Item 1A Risk Factors” of Part I of this Annual Report on Form 10-K.  We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. For a further discussion of the risks relating to our business, see “Item 1A Risk Factors” of Part I of this Annual Report on Form 10-K.

WEBSITE AND SOCIAL MEDIA DISCLOSURE

We use our website (www.medpace.com) and our corporate Facebook, YouTube, LinkedIn, Vimeo, Instagram and Twitter accounts as channels of distribution of company information. The information we post through these channels may be deemed material. Accordingly, investors should monitor these channels, in addition to following our press releases, Securities and Exchange Commission, or SEC, filings and public conference calls and webcasts. The contents of our website and social media channels are not, however, a part of this report.

TRADEMARKS

We own or have the rights to use various trademarks referred to in this Annual Report on Form 10-K, including, among others, Medpace and ClinTrak and their respective logos. Solely for convenience, we may refer to trademarks in this Annual Report on Form 10-K without the TM and ® symbols. Such references are not intended to indicate, in any way, that we will not assert, to the fullest extent permitted by law, our rights to our trademarks. Other trademarks appearing in this Annual Report on Form 10-K are the property of their respective owners.

- 3 -


MARKET AND INDUSTRY INFORMATION

Market data used throughout this Annual Report on Form 10-K is based on management’s knowledge of the industry and the good faith estimates of management. All of management’s estimates presented herein are based on industry sources, including analyst reports and management’s knowledge. We also relied, to the extent available, upon management’s review of independent industry surveys and publications prepared by a number of sources and other publicly available information. We are responsible for all of the disclosure in this Annual Report on Form 10-K and while we believe that each of the publications, studies and surveys used throughout this Annual Report on Form 10-K are prepared by reputable sources, we have not independently verified market and industry data from third-party sources.

All of the market data used in this Annual Report on Form 10-K involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. While we believe the estimated market position, market opportunity and market size information included in this Annual Report on Form 10-K is generally reliable, such information, which in part is derived from management’s estimates and beliefs, is inherently uncertain and imprecise and has not been verified by any independent source. Projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Item 1A Risk Factors” of Part I of this Annual Report on Form 10-K and elsewhere in this Annual Report on Form 10-K. These and other factors could cause results to differ materially from those expressed in our estimates and beliefs and in the estimates prepared by independent parties. See “Forward-Looking Statements” above.

GLOSSARY

We define the terms below that appear throughout this report as follows:

“Large pharmaceutical companies.” Large pharmaceutical companies represent the top 20 pharmaceutical companies by worldwide prescription drug sales in the year ended December 31, 2017 as classified by Evaluate Ltd in EvaluatePharma© World Preview 2018 Outlook to 2024, an industry report.

“Mid-sized biopharmaceutical companies.” Mid-sized biopharmaceutical companies represent biopharmaceutical companies with at least $250 million in sales in the year ended December 31, 2017, based on publicly available data and management’s knowledge, that are not classified as a top 20 pharmaceutical company by Evaluate Ltd in EvaluatePharma© World Preview 2018 Outlook to 2024, an industry report.

“Phase I.” Phase I trials are typically conducted in healthy individuals or, on occasion, in patients, and typically involve 20 to 80 subjects and range from a few months to several years. These trials are designed to establish the basic safety, dose tolerance, absorption, metabolism, distribution and excretion of the clinical product candidate, the side effects associated with increasing doses, and if possible, early evidence of effectiveness. If the trial establishes the basic safety and metabolism of the clinical product candidate, Phase II trials are generally initiated.

“Phase II.” Phase II trials are conducted in a limited population of patients with the disease or condition that the clinical product candidate is intended to treat. These trials typically test a few hundred patients and last on average 12 to 18 months. Phase II trials are typically designed to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the clinical product candidate for specific targeted diseases or conditions, and to determine dose tolerance, optimal dosage and dosing schedule. Phase II trials are sometimes divided into two phases: Phase IIa trials typically evaluate the dose response of the clinical product candidate and Phase IIb trials typically evaluate the efficacy of the clinical product candidate at the prescribed doses. If the Phase II trials indicate that the clinical product candidate may be safe and effective, Phase III trials are generally initiated.

- 4 -


Phase III. Phase III trials evaluate the clinical product candidate in significantly larger and more diverse patient populations than Phase I and II trials and are conducted at multiple, geographically dispersed sites. On average, this phase lasts from one to three years. Depending on the size and complexity, Phase III CRO contracts may include multiple sequential trials. During this phase, the clinical product candidate’s overall benefit/risk ratio and the basis for product approval are established. If the clinical product candidate successfully completes Phase III, then the sponsor may submit a New Drug Application, or NDA, or Biologics License Application for approval by the United States Food and Drug Administration, or FDA, or a similar marketing authorization application for approval by non-U.S. regulatory agencies.

“Phase IV.” Phase IV or “post-approval” trials are intended to monitor the drug’s long-term risks and benefits, to analyze different dosage levels, to evaluate different safety and efficacy parameters in target populations or to substantiate marketing claims. Phase IV trials typically enroll thousands of patients and last from six months to several years. The FDA may require Phase IV testing and surveillance programs to monitor the effect of approved drugs which have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of post-marketing programs.

“Small biopharmaceutical companies.” Small biopharmaceutical companies represent biopharmaceutical companies that have less than $250 million in sales in the year ended December 31, 2017, based on publicly available data and management’s knowledge.

 

- 5 -


Part I 

Item 1. Business 

Overview

We are one of the world’s leading clinical contract research organizations, or CROs, by revenue, solely focused on providing scientifically-driven outsourced clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics. We differentiate ourselves from our competitors by our disciplined operating model centered on providing full-service Phase I-IV clinical development services and our therapeutic expertise. We believe this combination results in timely and cost-effective delivery of clinical development services for our customers. We believe that we are a partner of choice for small and mid-sized biopharmaceutical companies based on our ability to consistently utilize our full-service, disciplined operating model to deliver timely and high-quality results for our customers. Accordingly, we believe we are well positioned to continue to expand our market share in the growing Phase I-IV CRO market.

We were founded in 1992 by Dr. August J. Troendle, an industry pioneer, as a Phase II-IV focused CRO with a strong, scientifically-driven and disciplined operating model. Throughout our 26-year history, we have grown almost exclusively organically, with our core founding members having been integrally involved in developing and instilling our differentiated culture and operating philosophy across our company. We are led by a dedicated and experienced senior management team with significant industry experience and knowledge focused on clinical development. Our senior management team has an average tenure with Medpace of 13 years, including four senior managers with over 20 years with us, and brings a healthy balance of significant experience with Medpace, regulators and other companies in the industry. 

We focus on conducting clinical trials across all major therapeutic areas, with particular strength in Cardiology, Metabolic Disease, Oncology, Endocrinology, Central Nervous System, or CNS, and Antiviral and Anti-infective or AVAI, as well as therapeutic expertise in Medical Devices.

Our Market

Clinical Development Process

Before a new drug can be commercialized, it often must undergo extensive pre-clinical and clinical testing and regulatory review to verify safety and efficacy. CROs provide a comprehensive range of product development services for Phase I-IV clinical trials. These clinical trials are separated into distinct phases in order to thoroughly evaluate the product. Pharmaceutical Research and Manufacturers of America, 2018 Biopharmaceutical Research Industry Profile, a trade group publication, indicates that from drug discovery through approval by the United States Food and Drug Administration, or FDA, developing a new medicine takes approximately 10 to 15 years and costs approximately $2.6 billion.

- 6 -


The following graphic, based on data presented in the Pharmaceutical Research and Manufacturers of America, 2013 Biopharmaceutical Research Industry Profile and 2018 Biopharmaceutical Research Industry Profile, industry trade group publications, illustrates the various stages and typical timeline of the clinical development process:

Stages of Clinical Development

 

 

Our Services

We provide a full suite of services supporting the entire clinical development process from Phase I to Phase IV. We offer these services across a wide range of therapeutic areas.

Our comprehensive suite of clinical development services includes, but is not limited to, the following:

Medical Department

The medical department consists of therapeutic leads who provide strategic direction for study design and planning, train operational staff, work with primary investigators, provide medical monitoring and meet with regulatory agencies. Our customers rely on our expertise throughout the entire clinical trial process with therapeutically-focused physicians fully engaged throughout the study. We believe this depth of therapeutic leadership and engagement on each project results in a close working relationship with customers built on a level of trust that results in us being granted greater control over the clinical trial process.

Clinical Trial Management

Our team of clinical trial managers are responsible for leading all aspects of study execution. The clinical trial manager, or CTM, drives accountability across the functional team members and is responsible for successful operational execution. The CTM serves as the primary contact for the customer. Experience and therapeutic expertise are main factors when assigning CTMs to projects.

ClinTrak is integrated with our standard operating procedures (“SOPs”), allowing the CTMs to access real-time study metrics. ClinTrak is constantly evaluated and enhanced with our processes.

- 7 -


Data-Driven Feasibility

We have a dedicated feasibility team consisting of clinical experts who are an integrated part of the project team. Our feasibility team is able to analyze a specific protocol, using many data sources to determine countries and sites that are most appropriate for the study.

Study Start-Up

Our global Study Start-Up staff is well-versed in all aspects of clinical trial start up activities, including study documentation submission processes to independent Institutional Review Boards, or IRBs, ethics committees and to ex-US competent authorities. Our study start-up team includes fully dedicated budget and legal associates to ensure focused negotiations and execution of site contracts.

Patient Recruitment and Retention

We navigate the complex world of patient recruitment and retention by providing strategic solutions that address clinical program needs. Our dedicated internal patient recruitment and retention department supports the study team in providing an overall strategy that identifies patient motivators and any potential barriers to join the clinical research study, and includes recommended strategies to effectively engage and recruit patients, as well as how to retain the patients once they enroll.

Clinical Monitoring

Our clinical monitoring group consists of highly experienced clinical research associates, or CRAs. With their experience and training, our CRAs are able to provide unparalleled site management services that includes both in-house and onsite monitoring. Their knowledge of local regulations and laws, in addition to Good Clinical Practice, or GCP, and International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, guidelines ensure compliance and data quality. Our CRAs report into a global matrix structure to ensure consistent training, oversight and management. Each CRA receives comprehensive, hands-on training in an individualized curriculum consisting of in-house and field-based training, supplemented with clinical research department core rotations and ongoing study-specific training.

Risk-Based Monitoring

We support a comprehensive approach to monitoring to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the study. This approach focuses on prevention and mitigation of important and likely risks to the study, and is part of the overarching surveillance that Medpace utilizes to manage studies. Medpace utilizes this approach for all studies, regardless of whether a centralized monitoring approach is employed.

Regulatory Affairs

Our Regulatory Affairs department has a strong track record of providing expert strategic, operational, and tactical regulatory guidance, as well as creating thorough, scientifically-grounded regulatory compliant documentation to regulatory agencies around the globe. Members of this team bring a long tenure of regulatory experience and scientific knowledge to each project. The group, led by former government officials and experienced drug development subject matter experts, provides comprehensive international support at each stage of the drug and biologics development processes. They have particular expertise within the areas of advanced therapeutics, accelerated development pathways, pediatrics, and rare diseases. The group also has a dedicated publishing function that has full electronic and paper publishing capabilities to support all types of international regulatory submissions.

- 8 -


Medical Writing

Medical writers work closely with Medpace’s medical experts, biostatisticians, and other members of the study team to develop study protocols, clinical and statistical study reports, and integrated submission documents according to regulatory guidelines. Members of Medpace’s medical writing group possess substantial scientific knowledge and experience as well as strong communication skills. This skill set and collaborative approach coupled with a thorough quality control document review process, allow Medpace to produce high-quality, submission-ready documents for each contracted project.

Biometrics and Data Sciences

We provide customers with high-quality data collected during clinical trials that is the foundation of a successful clinical trial and forms the backbone of regulatory submissions, including New Drug Applications. We use global GCP-compliant SOPs, combined with continuous quality control, to ensure that data is consistent, efficient, and comprehensive.

Data Management: Our data management team develops detailed specifications for the collection, organization, validation, analysis and quality control of clinical trial data ensuring the most cost-effective, secure and regulatory compliant process.

Biostatistics: Our experienced team of biostatisticians provides trial design consulting, statistical methodology recommendations, programming expertise and reporting accuracy necessary to deliver clinical trials efficiently and on time. We offer comprehensive data analysis plans, thoroughly tested and validated customized programs, interpretation of study results, integrated efficacy and safety analysis for regulatory submissions, adaptive design and statistical support throughout the clinical trial.

Pharmacovigilance

Our safety and pharmacovigilance group collects, evaluates, analyzes and reports safety information. We provide global adverse event management, physician reviewed safety narrative writing and custom safety surveillance. Monitored by licensed physicians who are trained to provide oversight and to analyze and evaluate the emerging safety profile of the compound, we have designed our process to ensure safety and expedite approvals.

Core Laboratory

Our core laboratory services include both imaging services and cardiovascular core laboratory services. We partner with imaging experts from major academic and clinical institutions involved in research to provide image reading in a secure environment utilizing identical software and workstations integrated into ClinTrak allowing for prompt turnaround and oversight. Our imaging experts have clinical trial experience utilizing imaging modalities such as CT, MRI, PET/CT, 3D volumetric analysis, ultrasound, DEXA, angiography, endoscopy and photography. Our cardiovascular core laboratory provides state-of-the-art standardized electrocardiogram services and data analysis to support clinical trials.

Laboratories

Central Laboratory. Through our Central Laboratory, we provide comprehensive, full-service capabilities globally in four locations, including Cincinnati, Ohio; Leuven, Belgium; Beijing, China; and Singapore. The Central Laboratory has longstanding core competency in specialized esoteric testing, including biomarkers for efficacy in addition to standard assay offerings. Data consistency and harmonization are maintained utilizing global SOPs and reference ranges, identical analytic platforms, methodologies, reagent systems, calibrator and quality control programs, within a strict framework compliant with GCP requirements and regulatory guidelines to ensure laboratory data reflect the impact of the investigational compound and not differences in testing practices.

- 9 -


Bioanalytical Laboratory. Through our Bioanalytical Laboratory we provide highly scientific and value-added testing of biological samples using proprietary methods. Working in a Good Laboratory Practice compliant setting following FDA and European Medicines Agency, or EMA, guidelines, the Bioanalytical Laboratory delivers method transfer, development, validation, sample analysis and metabolite screening and identification of pre-clinical and clinical biological samples with expertise in developing proprietary, highly scientific, esoteric and sensitive tests. Areas of specific bioanalytical expertise include advanced mass spectrometry and immunoassay technologies for bioanalytical analysis and all bioanalytical aspects for small and large molecules. Our Bioanalytical Laboratory is located on our clinical research campus in Cincinnati, Ohio.

Biorepository. Medpace Biorepository Services offers solutions for comprehensive specimen life cycle management, which can begin with providing sample collection kits to sites through to receipt, processing, storage, retrieval and destruction. Our biorepository also provides opportunities to prospectively acquire specific specimens to answer early program decisions or gain insight into clinical trial subject stratification.

Molecular and genetic testing. Medpace supports sponsors with advanced testing to detect pathogenic events at the genome level including viral load and viral shedding, Microsatellite instability (MSI) testing, Sanger sequencing and fragment analysis and targeted gene sequencing panels.

The majority of our laboratory services are performed as a component of a full-service clinical development arrangement with our customers. We also offer our laboratory services on a stand-alone basis, although this has historically represented an immaterial amount of our net revenue. Regardless of the nature of the arrangement, our laboratory services are delivered consistently to our customers as a component of their clinical development activities.

Clinics

Our Clinics offering conducts studies in normal healthy volunteers, special populations, and patient populations over a spectrum of diseases and is located on our clinical research campus in Cincinnati, Ohio. Experience includes, but is not limited to: first-in-human, bioavailability/bioequivalence, single and multiple ascending dose, drug to drug interaction, food effect and device studies.

Quality Assurance

Our quality assurance team works closely with study teams to ensure compliance with protocols, SOPs and regulatory guidelines to ultimately protect research subject safety as well as the integrity and validity of study data. Our quality assurance team also provides services including regulatory training, internal system audits, SOP oversight, hosting of audits and regulatory inspections, as well as performs third party audits of critical vendors and investigative sites on behalf of our customers.

Customers

We have a well-diversified, attractively-positioned customer base that includes small biopharmaceutical companies, mid-sized biopharmaceutical companies and large pharmaceutical companies. We have conducted trials for many of the world’s leading pharmaceutical, biotechnology and medical device companies.

We have in the past and may in the future enter into arrangements with our customers or other drug, biologic or medical device companies in which we take on payment risk by making strategic investments in our customers or other drug companies, providing flexible payment terms or fee financing to customers or other companies, or entering into other risk sharing arrangements on trial execution.

- 10 -


Net New Business Awards and Backlog

New business awards represent the value of anticipated future net revenue that has been recognized in backlog during the period. This value is recognized upon the signing of a contract or receipt of a written pre-contract confirmation from a customer that confirms an agreement in principle on budget and scope. New business awards also include contract amendments, or changes in scope, where the customer has provided written authorization for changes in budget and scope or has approved us to perform additional work as of the measurement date. Awards may not be recognized as backlog after consideration of a number of factors, including whether (i) the relevant net revenue is expected only after a pending regulatory hurdle, which might result in cancellation of the study, (ii) the customer funding needed for commencement of the study is not believed to have been secured or (iii) study timelines are uncertain or not well defined timeline. In addition, study amounts that extend beyond a three-year timeline are not included in backlog. The number and amount of new business awards can vary significantly from period to period, and an award’s contractual duration can range from several months to several years based on customer and project specifications.

Cancellations arise in the normal course of business and are reflected when we receive written confirmation from the customer to cease work on a contractual agreement. The majority of our customers can terminate our contracts without cause upon 30 days’ notice. Similar to new business awards, the number and amount of cancellations can vary significantly period over period due to timing of customer correspondence and study-specific circumstances.

Net new business awards represent gross new business awards received in a period offset by total cancellations in that period. On an Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”) basis, net new business awards were $899.4 million for the year ended December 31, 2018. On an Accounting Standards Codification Topic 605, Revenue Recognition (“ASC 605”) basis, net new business awards were $581.0 million, $426.1 million and $427.0 million for the years ended December 31, 2018, 2017 and 2016, respectively.

Backlog represents anticipated future net revenue from net new business awards that have commenced, but have not been completed. Reported backlog will fluctuate based on new business awards, changes in scope to existing contracts, cancellations, net revenue recognition on existing contracts and foreign exchange adjustments from non-U.S. dollar denominated backlog. On an ASC 606 basis, as of December 31, 2018, our backlog was $1,057.9 million. On an ASC 605 basis, as of December 31, 2018, our backlog increased by $101.7 million, or 19.4%, to $626.1 million compared to $524.4 million as of December 31, 2017. Our backlog as of December 31, 2016 was approximately $483.9 million. Included within backlog on an ASC 606 basis as of December 31, 2018 is approximately $580 million to $600 million that we expect to convert to net revenue in 2019, with the remainder expected to convert to net revenue in years after 2019. Backlog and net new business award metrics may not be reliable indicators of our future period net revenue as they are subject to a variety of factors that may cause material fluctuations from period to period. These factors include, but are not limited to, changes in the scope of projects, cancellations and duration and timing of services provided. No assurance can be given that we will be able to realize the net revenue that is included in backlog. See “Item 1A. Risk Factors—Risks Relating to Our Business—Our backlog may not convert to net revenue at our historical conversion rates,” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—New Business Awards, Cancellations and Backlog” of Parts I and II, respectively, of this Annual Report on Form 10-K for more information.

Sales and Marketing

We employ an integrated sales and marketing team to sell our services to biotechnology, pharmaceutical and medical device companies.

We have an experienced and highly trained global team of professional business development representatives and business development support staff focused on securing business from both new and existing customers, through a consultative and strategic sales approach. We embed our medical and scientific experts from the beginning of the sales process when we first engage potential customers, and they remain embedded across the lifecycle of the sale and throughout the life of the project, program or partnership.

As part of its sales strategy, our business development team focuses on a customer segmentation model. Our team targets and engages customers in our addressable market, matches customer characteristics with therapeutic fit and

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maintains a mindset of full-service outsourcing. Our structured and disciplined approach facilitates strong account evaluation, which results in increased focus by the sales team, the development of effective and productive territories, the management of sales force effectiveness and the creation of a process whereby both marketing and sales operate under the same guiding principles.

We are able to consult collaboratively with our customers and help optimize timely completion of their clinical trials and programs, in part, because we engage our therapeutic experts from the beginning of the sales process and involve our regulatory affairs experts and highly trained operations team throughout the clinical trial process. Our sales team is then able to take the study design, regulatory plan and execution plan discussed up front and carry that through to the proposal and provide a final concept during one-on-one customer discussions and final CRO evaluations.

Our marketing team supports the business development function in three key areas, generating brand awareness through customized campaigns and web-site development, conference planning and lead generation through market research and business intelligence analysis. The marketing team is set up in two mirrored teams, one team to address our therapeutic strategy and tactics, and the second team to monitor and address market environment across our lines of business. All of our sales and marketing data are housed within a third party customer relationship management tool that provides us the analytics we need to make sales planning and sales management decisions.

Competition

We compete primarily against other full-service CROs as well as services provided by in-house research and development, or R&D, departments of biopharmaceutical companies. Our major CRO competitors include Laboratory Corporation of America Holdings, ICON plc, Syneos Health, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, LLC, PRA Health Sciences, Inc., IQVIA Holdings Inc. and numerous specialty and regional CROs.

We generally compete on the basis of a number of factors, including experience within specific therapeutic areas, quality of staff and services, reliability, range of provided services, ability to recruit principal investigators and patients into studies expeditiously, ability to organize and manage large-scale, global clinical trials, global presence with strategically located facilities, speed to completion, price and overall value. We believe we compete effectively with our competitors across these factors, particularly due to our full-service operating model, our deep therapeutic expertise in areas that are among the largest, most complex and fastest growing in pharmaceutical development, our global platform and our experienced and committed management team. However, some of our competitors have greater financial resources and a wider range of service offerings over a greater geographic area than we do, which could put us at a competitive disadvantage with respect to these competitors.

The CRO industry remains fragmented, with several hundred smaller, narrowly focused service providers and a small number of full-service companies with global capabilities. We believe there are significant barriers to others becoming a global provider offering a broad range of services and products including the cost and experience necessary to develop strong therapeutic areas, expertise to manage complex clinical programs, infrastructure to support large global programs, ability to deliver high-quality services and expertise required to prepare regulatory submissions in numerous jurisdictions.

Government Regulation

Development of Drugs, Biologics and Medical Devices

The development of drugs, biologics and medical devices is highly regulated in the United States and other countries. Our services are subject to varying regulatory requirements designed to ensure the quality and integrity of the pre-clinical and clinical trial process. In the United States, the FDA has primary authority to regulate these activities, in addition to the approval process, and the subsequent manufacturing, safety, labeling, storage, record keeping and marketing for these products, which are the responsibility of our customers. Before a marketing application for a drug is ready for submission to regulatory authorities, the candidate drug must often undergo rigorous testing in clinical trials. In the United States, these trials must be conducted in accordance with the Federal Food, Drug, and Cosmetic Act, its implementing regulations, and other federal and state requirements that require

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the drug to be tested and studied in certain ways prior to approval. The FDA has similar authority and requirements with respect to the clinical testing of biological products and medical devices. Before a human clinical trial may begin in the United States, the manufacturer or sponsor of the clinical product candidate must file an Investigational New Drug Application, or IND, with the FDA, which contains, among things, the results of pre-clinical tests, manufacturer information and other analytical data. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. Each clinical trial must be conducted pursuant to, and in accordance with, an effective IND. Each human clinical trial we conduct is subject to the oversight of an IRB, which is an independent committee that has the regulatory authority to review, approve and monitor a clinical trial for which the IRB has responsibility. The FDA and IRB receive reports on the progress of each phase of clinical testing and may require the modification, suspension, or termination of clinical trials if, among other things, an unreasonable risk is presented to patients or if the design of the trial is insufficient to meet its stated objective. In addition, information about certain clinical trials must be made publicly available on the federal government website, www.clinicaltrials.gov.

In the United States, GCP regulations govern the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. In order to comply with GCP and other requirements, we must, among other things:

 

comply with specific requirements governing the selection of qualified principal investigators and clinical research sites;

 

obtain specific written commitments from principal investigators;

 

obtain IRB review and approval and supervision of the clinical trials by an independent review board or ethics committee;

 

obtain a favorable opinion from regulatory agencies to commence a clinical trial;

 

verify that appropriate patient informed consents are obtained before the patient participates in a clinical trial;

 

ensure that adverse drug reactions resulting from the administration of a drug or biologic during a clinical trial are medically evaluated and reported in a timely manner;

 

monitor the validity and accuracy of data;

 

monitor drug or biologic accountability at clinical research sites; and

 

verify that principal investigators and clinical trial staff maintain records and reports and permit appropriate governmental authorities access to data for review.

Clinical trials conducted outside the United States are subject to the laws and regulations of the country where the trials are conducted. These laws and regulations may or may not be similar to the laws and regulations administered by the FDA and other laws and regulations regarding the protection of patient safety and privacy and the control of clinical trial pharmaceuticals, medical devices or other clinical trial materials. Within the EU, these requirements are enforced by the EMA and requirements may vary slightly from one member state to another. In Canada, clinical trials are regulated by the Health Products and Food Branch of Health Canada as well as provincial regulations. Similar requirements also apply in other jurisdictions, including countries outside the EU and countries in Asia and Latin America where we operate or where our customers may intend to apply for marketing authorization. Clinical trials conducted outside the United States also may be subject to FDA regulation if the clinical trials are conducted pursuant to an IND or an Investigational Device Exemption for a product candidate that will seek FDA approval or clearance. In addition, clinical trial sponsors follow ICH E6 guidelines as a principle for GCP.

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The clinical trial customer and the parties conducting the clinical trials share in responsibilities to ensure that all applicable legal and regulatory requirements are fulfilled. Many of the functions we regularly perform in the conduct of clinical trials subject us directly to regulations (e.g., compliance with GCP), and in some circumstances, we will take on legal and regulatory responsibility either through a transfer of obligations to us from our clinical trial customers or our acting as local legal representative for certain of our clinical trial customers. We may be subject to regulatory action if we fail to comply with these requirements. Failure to comply with certain regulations may also result in the termination of ongoing research and disqualification of data collected during the clinical trials. For example, violations of GCP could result, depending on the nature of the violation and the type of product involved, in the issuance of a warning letter, suspension or termination of a clinical trial, refusal of the FDA to approve clinical trial or marketing applications or withdrawal of such applications, injunction, seizure of investigational products, civil penalties, criminal prosecutions or debarment from assisting in the submission of new drug applications. See “Item 1A. Risk Factors—Risks Relating to Our Business—If we fail to perform our services in accordance with contractual requirements, government regulations and ethical considerations, we could be subject to significant costs or liability and our reputation could be adversely affected” of Part I of this Annual Report on Form 10-K.

We monitor our clinical trials to test for compliance with applicable laws and regulations in the United States and the foreign jurisdictions in which we operate. We have adopted SOPs that are designed to satisfy regulatory requirements and serve as a mechanism for controlling and enhancing the quality of our clinical trials. In the United States, our procedures were developed to ensure compliance with GCP and associated requirements.

Health Information Privacy

The confidentiality of personal health information, including patient-specific information collected during clinical trials, is heavily regulated in the United States and other countries. The U.S. Department of Health and Human Services has promulgated rules under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations, including the Privacy and Security Rules, or collectively, HIPAA, that govern the use, handling and disclosure of personally identifiable medical information. These regulations also establish procedures for the exercise of an individual’s rights and the methods permissible for de-identification of health information. HIPAA applies to “covered entities,” which include certain types of healthcare providers, as well as service providers to covered entities which access protected health information, known as “business associates.” Two of our subsidiaries, Medpace Clinical Pharmacology, LLC and C-MARC, LLC, are covered entities under HIPAA. Further, many investigators with whom we are involved in clinical trials are also directly subject to HIPAA as covered entities. There are instances where we may be considered a business associate of a covered entity investigator, and we have signed business associate agreements with some investigators. If we are determined to be a business associate, we would be directly liable for any breaches of protected health information and other HIPAA violations. We are also liable contractually under any business associate agreements we have signed with covered entities. In addition, we are also subject to privacy legislation in Canada under the federal Personal Information Protection and Electronic Documents Act, the Act Respecting the Protection of Personal Information in the Private Sector and the Personal Health Information Protection Act and privacy legislation in the EU under the 95/46/EC Privacy Directive on the protection and free movement of personal data, as replaced by the General Data Protection Regulation from early 2018 onwards. See “Item 1A. Risk Factors—Risks Relating to Our Industry—Current and proposed laws and regulations regarding the protection of personal data could result in increased risks of liability or increased cost to us or could limit our service offerings” of Part I of this Annual Report on Form 10-K.

Health Industry Arrangements

The conduct of pre-clinical and clinical trials may be subject to laws and regulations that are intended to prevent the misuse of government healthcare program funding. In the United States, these laws include, among others, the False Claims Act, which prohibits submitting or causing the submission of false statements or improper claims for government healthcare program payments; and the Anti-Kickback statute, which prohibits paying, offering to pay or receiving payment with the intent to induce the referral of services or items that are covered under a federal healthcare program. Violations of these laws and regulations may incur administrative, civil, and criminal penalties.

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Employee Safety and Workplace Conditions

Most of our employees are office based and subject to health and safety regulations covering offices, with which we comply. In addition to its comprehensive regulation of safety in the workplace, the U.S. Occupational Safety and Health Administration has established extensive requirements relating to workplace safety for healthcare employers whose workers might be exposed to blood-borne pathogens such as HIV and the hepatitis B virus, which apply to our clinic and laboratories. Furthermore, certain employees might have to receive initial and periodic training to ensure compliance with applicable hazardous materials regulations and health and safety guidelines. We are subject to similar regulations with respect to our laboratories in Belgium, Singapore and China.

Environmental Regulation and Liability

We are subject to various laws and regulations relating to the protection of the environment and human health and safety in the countries in which we do business, including laws and regulations governing the management and disposal of hazardous substances and wastes, the cleanup of contaminated sites and the maintenance of a safe workplace. Our operations include the use, generation and disposal of hazardous materials and medical wastes. We may, in the future, incur liability under environmental statutes and regulations for contamination of sites we own or operate (including contamination caused by prior owners or operators of such sites), the off-site disposal of hazardous substances and for personal injuries or property damage arising from exposure to hazardous materials from our operations. We believe that we have been and are in substantial compliance with all applicable environmental laws and regulations and that we currently have no liabilities under such environmental requirements that could reasonably be expected to materially harm our business, results of operations or financial condition.

Intellectual Property

We develop and use a number of proprietary methodologies, analytics, systems, technologies and other intellectual property in the conduct of our business. We rely upon a combination of confidentiality policies, nondisclosure agreements and other contractual arrangements to protect our trade secrets, and copyright and trademark laws to protect other intellectual property rights. We have obtained or applied for trademarks and copyright protection in the United States and in a number of foreign countries. Our material trademarks include Medpace and ClinTrak. Although the duration of trademark registrations varies from country to country, trademarks generally may be renewed indefinitely so long as they are in use and/or their registrations are properly maintained, and so long as they have not been found to have become generic. Although we believe the ownership of trademarks is an important factor in our business and that our success does depend in part on the ownership thereof, we rely primarily on the innovative skills, technical competence and marketing abilities of our employees. We do not have any material licenses, franchises or concessions.

Employees

As of December 31, 2018 we had approximately 2,900 employees worldwide. None of our employees are currently covered by a collective bargaining agreement specific to our company. We believe our overall relations with our employees are good. As of December 31, 2017 and 2016, we had approximately 2,500 employees.

The success of our business depends upon our ability to attract and retain qualified professional, scientific and technical staff. The level of competition among employers in the United States and overseas for skilled personnel, particularly for those with Ph.D., M.D. or equivalent degrees or training, is high. We believe that our brand recognition and our multinational presence are advantages in attracting qualified candidates. We also believe that the wide range of clinical trials in which we participate allows us to offer broad experience to clinical researchers. In addition, our disciplined and centralized approach to hiring and training has fostered, and we believe will continue to foster, strong employee loyalty and a low turnover rate.

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Liability and Insurance

We may be liable to our customers for any failure to conduct their clinical trials properly according to the agreed-upon protocol and contract. If we fail to conduct a clinical trial properly in accordance with the agreed-upon procedures, we may have to repeat a clinical trial or a particular portion of the services at our expense, reimburse the customer for the cost of the services and/or pay additional damages.

At our Phase I clinic, we study the effects of drugs on healthy volunteers. In addition, in our clinical business we, on behalf of our customers, contract with physicians who render professional services, including the administration of the substance being tested to participants in clinical trials, many of whom are seriously ill and are at great risk of further illness or death as a result of factors other than their participation in a trial. As a result, we could be held liable for bodily injury, death, pain and suffering, loss of consortium or other personal injury claims and medical expenses arising from a clinical trial. In addition, we sometimes engage the services of vendors necessary for the conduct of a clinical trial, such as laboratories or medical diagnostic specialists. Because these vendors are engaged as subcontractors, we are responsible for their performance and may be held liable for damages if the subcontractors fail to perform in the manner specified in their contract.

To reduce our potential liability, and as a requirement of the GCP regulations, informed consent is required from each volunteer and patient. In addition, our customers provide us with contractual indemnification for all of our service related contracts. These indemnities generally do not, however, protect us against certain of our own actions such as those involving negligence or misconduct. Our business, financial condition and operating results could be harmed if we were required to pay damages or incur defense costs in connection with a claim that is not indemnified, that is outside the scope of an indemnity or where the indemnity, although applicable, is not honored in accordance with its terms.

We maintain professional liability insurance in amounts we believe to be appropriate. This insurance provides coverage for vicarious liability due to negligence of the investigators who contract with us, as well as claims by our customers that a clinical trial was compromised due to an error or omission by us. If our insurance coverage is not adequate, or if insurance coverage does not continue to be available on terms acceptable to us, our business, financial condition and operating results could be materially harmed.

Available Information

We are subject to the informational requirements of the Exchange Act and, in accordance therewith, file reports, including annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission, or the SEC. Copies of our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and our Proxy Statements for our annual meetings of stockholders, and any amendments to those reports, as well as Section 16 reports filed by our insiders, are available free of charge on our website as soon as reasonably practicable after we file the reports with, or furnish the reports to the SEC. Our website address is http://www.medpace.com, and our investor relations website is located at investor.medpace.com. Information on our website is not incorporated by reference herein. The SEC maintains an Internet site (http://www.sec.gov) containing reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.

Item 1A. Risk Factors

Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with the other information included in this Annual Report on Form 10-K. The occurrence of any of the following risks may materially and adversely affect our business, financial condition, results of operations and future prospects. In these circumstances, the market price of our common stock could decline. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.  

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Risks Relating to Our Business

The potential loss, delay or non-renewal of our contracts, or the non-payment by our customers for services that we have performed, could adversely affect our results.

We experience termination, cancellation and non-renewals of contracts by our customers in the ordinary course of business, and the number and dollar value of cancellations can vary significantly from year to year.

The time between when a clinical trial is awarded and when it goes to contract is typically several months, and prior to a new business award going to contract, our customers can cancel the award without notice. Moreover, once an award goes to contract, most of our customers for clinical trial services can terminate our contracts without cause upon 30 days’ notice. Our customers may delay, terminate or reduce the scope of our contracts for a variety of reasons beyond our control, including, but not limited to:

 

decisions to forego or terminate a particular clinical trial;

 

lack of available financing, budgetary limits or changing priorities;

 

actions by regulatory authorities;

 

changes in law;

 

production problems resulting in shortages of the drug being tested;

 

failure of the drug being tested to satisfy safety requirements or efficacy criteria;

 

unexpected or undesired clinical results;

 

insufficient investigator recruitment or patient enrollment in a trial;

 

decisions to downsize product development portfolios due to general economic conditions, Market conditions or otherwise;

 

dissatisfaction with our performance, including the quality of data provided and our ability to meet agreed upon schedules;

 

shift of business to another CRO or internal resources;

 

product withdrawal following market launch; or

 

shut down of our customers’ manufacturing facilities.

As a result, contract terminations, delays and modifications are a regular part of our business. In the event of termination, our contracts often provide for payment to us of fees for services provided up to the point of termination and for close-out activities for winding down the clinical trial, and reimbursement of all non-cancellable expenses. These payments may not be sufficient for us to maintain our profit margins or recover our costs, and termination or non-renewal may result in lower resource utilization rates, including with respect to personnel who we are not able to place on another customer engagement. Historically, cancellations and delays have negatively impacted our operating results.

Clinical trials can be costly and for the year ended December 31, 2018, 69% and 24% of our net revenue was derived from small biopharmaceutical companies and mid-sized biopharmaceutical companies, respectively, which may have limited access to capital. In addition, we provide services to our customers before they pay us for some of our services. There is a risk that we may initiate a clinical trial for a customer, and the customer subsequently becomes unwilling or unable to fund the completion of the trial. In such a situation, notwithstanding the customer’s ability or willingness to pay for or otherwise facilitate the completion of the trial, we may be legally or ethically bound to complete or wind down the trial at our own expense.

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Because the contracts included in our backlog are generally terminable without cause, we do not believe that our backlog as of any date is necessarily a meaningful predictor of future results. In addition, we may not realize the full benefits of our backlog of contractually committed services if our customers cancel, delay or reduce their commitments under our contracts with them. Thus, the loss or delay of a large contract or the loss or delay of multiple contracts could adversely affect our net revenue and profitability. In addition, the terminability of our contracts puts increased pressure on our quality control efforts, since not only can our contracts be terminated by customers as a result of poor performance, but any such termination may also affect our ability to obtain future contracts from the customer involved and others.

Our backlog may not convert to net revenue at our historical conversion rates.

Backlog represents anticipated future net revenue from net new business awards that have commenced, but have not been completed. Reported backlog will fluctuate based on new business awards, changes in scope to existing contracts, cancellations, revenue recognition on existing contracts and foreign exchange adjustments from non-U.S. dollar denominated backlog.  Once work begins on a project, net revenue is recognized over the duration of the project. Projects may be terminated or delayed by the customer or delayed by regulatory authorities for reasons beyond our control. To the extent projects are delayed, the timing of our net revenue could be adversely affected. Moreover, in the event that a customer cancels a contract, we often would be entitled to receive payment for services provided up to the point of cancellation and for close-out activities for winding down the clinical trial, and reimbursement of all non-cancellable expenses. Typically, however, we have no contractual right to the full amount of the future net revenue reflected in our backlog in the event of a contract cancellation or subsequent changes in scope that reduce the value of the contract. The duration of the projects included in our backlog, and the related net revenue recognition, generally range from a few months to several years. Our backlog may not be indicative of our future net revenue, and we may not realize all of the anticipated future net revenue reflected in our backlog. A number of factors may affect the realization of our net revenue from backlog, including:

 

the size, complexity and duration of the projects;

 

the cancellation or delay of projects; and

 

changes in the scope of work during the course of a project.

Fluctuations in our reported backlog levels also result from the fact that we may receive a small number of relatively large projects in any given reporting period that may be included in our backlog. Because of these large projects, our backlog in that reporting period may reach levels that may not be sustained in subsequent reporting periods. Additionally, although an increase in backlog will generally result in an increase in net revenue over time, an increase in backlog at a particular point in time does not necessarily correspond directly to an increase in net revenue during any particular period, or at all. The extent to which contracts in backlog will result in net revenue depends on many factors, including, but not limited to, delivery against project schedules, scope changes, contract terminations and the nature, duration and complexity of the contracts, and can vary significantly over time.

As we increasingly compete for and enter into large contracts that are more global in nature, there can be no assurance about the rate at which our backlog will convert into net revenue. A decrease in this conversion rate would mean that the rate of net revenue recognized on contracts may be slower than what we have experienced in the past, which could impact our net revenue and results of operations on a quarterly and annual basis. The revenue recognition on larger, more global projects could be slower than on smaller, less global projects for a variety of reasons, including, but not limited to, an extended period of negotiation between the time the project is awarded to us and the actual execution of the contract, as well as an increased timeframe for obtaining the necessary regulatory approvals. Additionally, delayed projects will remain in backlog and will not generate revenue at the rate originally expected. Thus, the relationship of backlog to realized revenues is indirect and may vary significantly over time.

Additionally, if small and mid-sized biopharmaceutical companies become less able to access capital in the future, we may see a decrease in backlog conversion to net revenue and net new business awards due to project delays or cancellations. These companies have contributed materially to our historical net revenue. If they cannot commit the same or a greater level of capital to our services going forward, our results of operations may suffer.

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Our operating results have historically fluctuated between fiscal quarters and years and may continue to fluctuate in the future, which may adversely affect the market price of our stock.

Our operating results have fluctuated in previous quarters and years and may continue to vary significantly from quarter to quarter and year to year and are influenced by a variety of factors, such as:

 

timing of contract amendments for changes in scope that could affect the value of a contract and potentially impact the amount of net new business awards and net revenue from quarter to quarter;

 

commencement, completion, execution, postponement or termination of large contracts;

 

contract terms for the billing and recognition of revenue milestones;

 

progress of ongoing contracts and retention of customers;

 

timing of and charges associated with completion of acquisitions and other events;

 

changes in the mix of services delivered, both in terms of geography and type of services;

 

customer disputes or other issues that may impact the revenue we are able to recognize or the collectability of our related accounts receivable

 

exchange rate fluctuations; and

 

adoption of Accounting Standards Updates released by the Financial Accounting Standards Board

Our operating results for any particular quarter or year are not necessarily a meaningful indicator of future results and fluctuations in our quarterly or yearly operating results could negatively affect the market price and liquidity of shares of our common stock.

Our operating margins could decrease due to increased pricing pressure or other pressures.

Historically, we have been able to generate the operating margins that we do because of our disciplined, full-service operating model. However, we operate in a highly competitive environment, and, if we experience increased levels of competitive pricing pressure, our operating margins may decrease. In addition, we may adapt our operating model to achieve greater levels of growth or in response to investor demands. Such changes could result in lower operating margins.

If we fail to perform our services in accordance with contractual requirements, government regulations and ethical considerations, we could be subject to significant costs or liability and our reputation could be adversely affected.

We contract with biopharmaceutical companies to perform a wide range of services to assist them in bringing new drugs to market. Our services include monitoring clinical trials, data and laboratory analysis, electronic data capture, patient recruitment and other related services. Such services are complex and subject to contractual requirements, government regulations, and ethical considerations. For example, we are subject to regulation by the FDA, and comparable foreign regulatory authorities relating to our activities in conducting pre-clinical studies and clinical trials. Before clinical trials begin in the United States, a drug is tested in pre-clinical trials that must comply with Good Laboratory Practice and other requirements. An applicant must file an IND, which must become effective before human clinical testing may begin. Further, an independent IRB, for each medical center proposing to participate in the clinical trial must review and approve the protocol for the clinical trial. Once initiated, clinical trials must be conducted pursuant to and in accordance with the applicable IND conditions, the requirements of the relevant IRBs, the Federal Food, Drug, and Cosmetic Act and its implementing regulations, including GCP, and other requirements. We are also subject to regulation by the Drug Enforcement Administration, or DEA, which regulates the distribution, recordkeeping, handling, security, and disposal of controlled substances. If we fail to perform our services in accordance with these requirements, regulatory authorities may take action against us or our customers. Such actions may include injunctions or failure of such regulatory authority to grant marketing approval of our customers’ products, imposition of clinical holds or delays, suspension or withdrawal of approvals, rejection of data collected in our clinical trials, license revocation, product seizures or recalls, operational restrictions, civil or criminal penalties or prosecutions, damages or fines. Customers may also bring claims against us for breach of our contractual obligations, and patients in the clinical trials and patients taking drugs approved on the basis of those trials may bring personal injury claims against us. Any such action could have a material adverse effect on our business, financial condition, results of operations, cash flows or reputation.

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Such consequences could arise if, among other things, the following occur:

Improper performance of our services. The performance of clinical development services is complex and time-consuming. For example, we may make mistakes in conducting a clinical trial that could negatively impact or obviate the usefulness of results of the trial or cause the results of the trial to be reported improperly. If the trial results are compromised, we could be subject to significant costs or liability, which could have an adverse impact on our ability to perform our services and our reputation would be harmed. As examples:

 

non-compliance generally could result in the termination of ongoing clinical trials or the disqualification of data for submission to regulatory authorities;

 

non-compliance could compromise data from a particular trial, such as failure to verify that adequate informed consent was obtained from patients, which could require us to repeat the trial under the terms of our contract at no further cost to our customer, but at a potentially substantial cost to us; and

 

breach of a contractual term could result in liability for damages or termination of the contract.

The services we provide in connection with large clinical trials can cost tens of millions of dollars, and while we endeavor to contractually limit our exposure to such risks, improper performance of our services could have a material adverse effect on our financial condition, damage our reputation and result in the cancellation of current contracts by the affected customer or other current customers or failure to obtain future contracts from the affected customer or other current or potential customers.

Investigation of customers. From time to time, one or more of our customers are investigated by regulatory authorities or enforcement agencies with respect to regulatory compliance of their clinical trials, programs or the marketing and sale of their drugs. In these situations, we have often provided services to our customers with respect to the clinical trials, programs or activities being investigated, and we are called upon to respond to requests for information by the authorities and agencies. There is a risk that either our customers or regulatory authorities could claim that we performed our services improperly or that we are responsible for clinical trial or program compliance. If our customers or regulatory authorities make such claims against us, we could be subject to significant costs in defending our activities and potential damages, fines or penalties. In addition, negative publicity regarding regulatory compliance of our customers’ clinical trials, programs or products could have an adverse effect on our business and reputation.

Insufficient customer funding to complete a clinical trial. As noted above, clinical trials can cost tens of millions of dollars. There is a risk that we may initiate a clinical trial for a customer, and then the customer becomes unwilling or unable to fund the completion of the trial. In such a situation, notwithstanding the customer’s ability or willingness to pay for or otherwise facilitate the completion of the trial, we may be ethically bound to complete or wind down the trial at our own expense.

Interactive voice/web response service malfunction. We develop and maintain our own, and also use third-parties to run, interactive voice/web response systems. These systems automatically manage the randomization of patients in a given clinical trial to different treatment arms and regulate the supply of investigational drugs. An error in the design, programming or validation of these systems could lead to inappropriate assignment or dosing of patients which could give rise to patient safety issues, invalidation of the trial or liability claims against us. Furthermore, negative publicity associated with such a malfunction could have an adverse effect on our business and reputation. Additionally, errors in randomization may require us to repeat the trial at no further cost to our customer, but at a substantial cost to us.

In addition to the above U.S. laws and regulations, we must comply with the laws of all countries where we do business, including laws governing clinical trials in the jurisdiction where the trials are performed. Failure to comply with applicable requirements could subject us to regulatory risk, liability and potential costs associated with redoing the trials, which could damage our reputation and adversely affect our operating results.

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We bear financial risk if we underprice our fixed-fee contracts or overrun cost estimates, and our financial results can also be adversely affected by failure to receive approval for change orders or delays in documenting change orders.

The majority of our Phase I–IV contracts are fixed-fee contracts. We bear the financial risk if we initially underprice our contracts or otherwise overrun our cost estimates. In addition, contracts with our customers are subject to change orders, which we commonly experience and which occur when the scope of work we perform needs to be modified from that originally contemplated by our contract with the customer. Modifications can occur, for example, when there is a change in a key trial assumption or parameter, a significant change in timing or a change in staffing needs. Furthermore, we may be unable to successfully negotiate changes in scope or change orders on a timely basis or at all, which could require us to incur cost outlays ahead of the receipt of any additional revenue. In addition, under US GAAP, we cannot recognize additional revenue anticipated from change orders until appropriate documentation is received by us from the customer authorizing the change. However, if we incur additional expense in anticipation of receipt of that documentation, we must recognize the expense as incurred. Such underpricing, significant cost overruns or delay in documentation of change orders could have a material adverse effect on our business, results of operations, financial condition or cash flows.

If we are unable to successfully execute our growth strategies, our results of operations or financial condition could be adversely affected.

Our key growth strategies include: continued organic growth, continued maintenance of margins, increasing capture of the high-growth clinical development market, deepening existing and developing new relationships with our core customer segment and pursuing selective and complementary bolt-on acquisitions. Though we will strive to meet these goals, we may not have or adequately build the competencies necessary to achieve our objectives. In addition, we may not receive market acceptance for our services and we may face increased competition. If we are unable to successfully continue our organic growth, continue to maintain our margins, increase our capture of the clinical development market, deepen existing and develop new relationships with our core customer segment, pursue complementary and non-transformative acquisitions or attract additional large pharmaceutical company customers, our future business, reputation, results of operations and financial condition could be adversely affected.

If we lose the services of key personnel or are unable to recruit experienced personnel, our business could be adversely affected.

Our success substantially depends on the collective performance, contributions and expertise of our senior management team, including Dr. August J. Troendle, our Chief Executive Officer and founder, and other key personnel including qualified management, professional, scientific and technical operating staff. There is significant competition for qualified personnel in the biopharmaceutical services industry, particularly for those with higher educational degrees, such as a medical or nursing degree, a Ph.D., or an equivalent degree, and our industry generally tends to experience relatively high levels of employee turnover. If any of our key employees were to join a competitor or to form a competing company, some of our customers might choose to use the services of that competitor or new company instead of our own. Furthermore, customers or other companies seeking to develop in-house capabilities may hire some of our senior management or other key employees. The departure of any key contributor, the payment of increased compensation to attract and retain qualified personnel or our inability to continue to identify, attract and retain qualified personnel or replace any departed personnel in a timely fashion may impact our ability to grow our business and compete effectively in our industry and may negatively affect our business, financial condition, results of operations, cash flows or reputation.  

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Our business depends on the continued effectiveness and availability of our information systems, including the information systems we use to provide our services to our customers, such as ClinTrak, and failures of these systems may materially limit our operations.

Due to the global nature of our business and our reliance on information systems to provide our services, we intend to increase our use of web-enabled and other integrated information systems in delivering our services. We already provide access to such an information system, ClinTrak, to certain of our customers in connection with the services we provide to them. As the breadth and complexity of our information systems continue to grow, we will increasingly be exposed to the risks inherent in the development, integration and ongoing operation of evolving information systems, including:

 

disruption, impairment or failure of data centers, telecommunications facilities or other key infrastructure platforms;

 

security breaches of, cyberattacks on and other failures or malfunctions in our critical application systems or their associated hardware; and

 

excessive costs, excessive delays or other deficiencies in systems development and deployment.

The materialization of any of these risks may impede the processing of data, the delivery of databases and services and the day-to-day management of our business and could result in the corruption, loss or unauthorized disclosure of proprietary, confidential or other data. While we have disaster recovery plans in place, they might not adequately protect us in the event of a system failure. Despite any precautions we take, damage from fire, floods, hurricanes, power loss, telecommunications failures, computer viruses, information system security breaches and similar events at our facilities or at those of our third party provider that backs up our data centers could result in interruptions in the flow of data to our servers and from our servers to our customers. Corruption or loss of data may result in the need to repeat a trial at no cost to the customer, but at significant cost to us, or result in the termination of a contract or damage to our reputation. Moreover, regulatory authorities may impose requirements on the use of electronic records and signatures for regulatory purposes. For example, FDA’s regulations at 21 CFR Part 11 establish the criteria pursuant to which the FDA will consider electronic records and signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. Any failures to comply with those regulatory requirements could impact our customers’ ability to rely on the data contained in those electronic records in our systems or result in the FDA’s rejection of the data. Additionally, in order for our information systems to continue to be effective going forward, we periodically need to upgrade our technology systems and increase our capacity to keep pace with technological developments and our growth as a company. Significant delays in system enhancements or inadequate performance of new or upgraded systems once completed could damage our reputation and harm our business. Our operations also may suffer if we are unable to effectively manage the implementation of and adapt to new technology systems. We have entered into agreements with certain vendors to provide systems development and integration services that develop or license to us the IT platform for programs to optimize our business processes. If such vendors fail to perform as required or if there are substantial delays in developing, implementing and updating the IT platform, our customer delivery may be impaired, and we may have to make substantial further investments, internally or with third parties, to achieve our objectives. Additionally, our progress may be limited by parties with existing or claimed patents who seek to prevent us from using preferred technology or seek license payments from us. Any such shortcoming may require us to make substantial further investments in our IT platform, which could adversely affect our financial results. Finally, long-term disruptions in the infrastructure caused by events such as natural disasters, the outbreak of war, the escalation of hostilities and acts of terrorism, particularly involving cities in which we have offices, could adversely affect our business. As our business continues to expand globally, these types of risks may be further increased by instability in the geopolitical climate of certain regions, underdeveloped and less stable utilities and communications infrastructure and other local and regional factors. Although we carry property and business interruption insurance, our coverage might not be adequate to compensate us for all losses that may occur.

Unauthorized disclosure of sensitive or confidential data, whether through system failure or breaches or employee negligence, fraud or misappropriation, could damage our reputation and cause us to lose customers. Similarly, unauthorized access to or through our information systems or those we develop for our customers, whether by our employees or third parties, including a cyberattack by computer programmers and hackers who may develop and deploy viruses, worms or other malicious software programs, could result in negative publicity, significant remediation costs, legal liability and damage to our reputation and could have a material adverse effect on our results of operations. In addition, our liability insurance might not be sufficient in type or amount to adequately cover us against claims related to security breaches, cyberattacks and other related breaches.

 

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If the security of confidential information used in connection with our services is breached or otherwise subject to unauthorized access, our reputation and business may be materially harmed.

Our services require us to collect, store, use, and transmit significant amounts of confidential information, including personally identifiable information, and other critical data. We employ a range of information technology solutions, controls, procedures, and processes designed to protect the confidentiality, integrity, and availability of our critical assets, including our data and information technology systems. While we engage in a number of measures aimed to protect against security breaches and to minimize problems if a data breach were to occur, our information technology systems and infrastructure may be vulnerable to damage, compromise, disruption, and shutdown due to attacks or breaches by hackers or due to other circumstances, such as error or malfeasance by employees or third party service providers or technology malfunction. The occurrence of any of these events, as well as a failure to promptly remedy these events should they occur, could compromise our systems, and the information stored in our systems could be accessed, publicly disclosed, lost, stolen, or damaged. Any such circumstance could adversely affect our ability to attract and maintain customers, cause us to suffer negative publicity, and subject us to legal claims and liabilities or regulatory penalties. In addition, unauthorized parties might alter information in our databases, which would adversely affect both the reliability of that information and our ability to market and perform our services. Techniques used to obtain unauthorized access or to sabotage systems change frequently, are constantly evolving and generally are difficult to recognize and react to effectively. We may be unable to anticipate these techniques or to implement adequate preventive or reactive measures. Several recent, highly publicized data security breaches at other companies have heightened consumer awareness of this issue and may embolden individuals or groups to target our systems or those of our strategic partners or enterprise customers.

Our business could be harmed if we are unable to manage our growth effectively.

We believe that sustained growth places a strain on human, operational and financial resources. To manage our growth, we must continue to attract and retain qualified management, professional, scientific and technical operating personnel and to improve our operating and administrative systems. We believe that maintaining and enhancing both personnel and our systems at reasonable cost are instrumental to our success. We cannot assure you that we will be able to attract and retain qualified operating personnel due to competitiveness in the industry around hiring. Additionally, we cannot assure you that we will be able to enhance our current technology or obtain new technology that will enable our systems to keep pace with developments and the needs of our customers. The nature and pace of our growth introduces risks associated with quality control and customer dissatisfaction due to delays in performance or other problems. In addition, foreign operations involve the additional risks of assimilating differences in foreign business practices, hiring and retaining qualified personnel and overcoming language barriers. Failure to manage growth effectively could have a material adverse effect on our business.

Our customer or therapeutic area concentration may have a material adverse effect on our business, financial condition, results of operations or cash flows.

Although we did not have any customer that represented 10% or more of our net revenue during the year ended December 31, 2018, we derive a significant portion of our revenues from a limited number of large customers. For the year ended December 31, 2018, we derived 33.0% and 5.8% of our net revenue from our top 10 customers and our largest customer, respectively. In addition, approximately 32.9% and 7.9% of our backlog, as of December 31, 2018, was concentrated among our top 10 customers and our largest customer by backlog concentration, respectively. Moreover, 7.9% of our backlog, as of December 31, 2018, was concentrated with our largest customer by net revenue. If any large customer decreases or terminates its relationship with us, our business, financial condition, results of operations or cash flows could be materially adversely affected. Also, consolidation in our actual or potential customer base results in increased competition for important market segments and fewer available customer accounts.

Additionally, conducting multiple clinical trials for different sponsors in a single therapeutic class, involving similar drugs, biologics or medical devices, may adversely affect our business if some or all of the trials are terminated because of new scientific information or regulatory decisions that affect the products as a class. Moreover, even if these trials are not terminated, they may compete with each other, thereby limiting our potential revenue going forward.

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Our business is subject to international economic, political and other risks that could negatively affect our results of operations and financial condition.

We have significant operations in foreign countries, including, but not limited to, countries in Europe, Latin America, Asia, the Middle East and Africa, that may require complex arrangements to deliver services on global contracts for our customers.  As a result, we are subject to heightened risks inherent in conducting business internationally, including the following:

 

conducting a single trial across multiple countries is complex, and issues in one country, such as a failure to comply with local regulations or restrictions, may affect the progress of the trial in the other countries, for example, by limiting the amount of data necessary for a trial to proceed, resulting in delays or potential cancellation of contracts, which in turn may result in loss of revenue;

 

the United States or other countries could enact legislation or impose regulations or other restrictions, including unfavorable labor regulations or tax policies, which could have an adverse effect on our ability to conduct business in or expatriate profits from those countries;

 

tax rates in certain foreign countries may exceed those in the United States and foreign earnings may be subject to withholding requirements or the imposition of tariffs, exchange controls or other restrictions, including restrictions on repatriation;

 

certain foreign countries are expanding or may expand their regulatory framework with respect to patient informed consent, protection and compensation in clinical trials, and privacy, which could delay or inhibit our ability to conduct trials in such jurisdictions or which could materially increase the risks associated with performing trials in such jurisdictions;

 

certain foreign countries are expanding or may expand their banking regulations that govern international currency transactions, particularly cross-border transfers, which may inhibit our ability to transfer funds into or within a jurisdiction, impeding our ability to pay our principal investigators, vendors and employees, thereby impacting our ability to conduct trials in such jurisdictions;

 

the regulatory or judicial authorities of foreign countries may not enforce legal rights and recognize business procedures in a manner to which we are accustomed or would reasonably expect;

 

we may have difficulty complying with a variety of laws and regulations in foreign countries, some of which may conflict with laws in the United States;

 

potential violations of existing or newly adopted local laws or anti-bribery laws, such as the United States Foreign Corrupt Practices Act, or FCPA, and the UK Bribery Act of 2010, may cause a material adverse effect on our business, financial condition, results of operations, cash flows or reputation;

 

changes in political and economic conditions, including inflation, may lead to changes in the business environment in which we operate, as well as changes in foreign currency exchange rates;

 

foreign governments may enact currency exchange controls that may limit the ability to fund our operations or significantly increase the cost of maintaining operations;

 

customers in foreign jurisdictions may have longer payment cycles, and it may be more difficult to collect receivables in foreign jurisdictions; and

 

natural disasters, pandemics or international conflict, including terrorist acts, could interrupt our services, endanger our personnel or cause project delays or loss of trial materials or results.

These risks and uncertainties could negatively impact our ability to, among other things, perform large, global projects for our customers. Furthermore, our ability to deal with these issues could be affected by applicable U.S. laws and the need to protect our assets. In addition, we may be more susceptible to these risks as we enter and continue to target growth in emerging countries and regions, including Asia, Eastern Europe and Latin America, which may be subject to a relatively higher risk of political instability, economic volatility, crime, corruption and social and ethnic unrest, all of which are exacerbated in many cases by a lack of an independent and experienced judiciary and uncertainties in how local law is applied and enforced. The materialization of any such risks could have an adverse impact on our financial condition, results of operations, cash flows or reputation.

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Due to the global nature of our business, we may be exposed to liabilities under the Foreign Corrupt Practices Act and various other anti-corruption laws, and any allegation or determination that we violated these laws could have a material adverse effect on our business.

We are required to comply with the FCPA, UK Bribery Act of 2010 and other U.S. and foreign anti-corruption laws, which prohibit companies from engaging in bribery including corruptly or improperly offering, promising, or providing money or anything else of value to foreign officials and certain other recipients. In addition, the FCPA imposes certain books, records and accounting control obligations on public companies and other issuers. We operate in parts of the world in which corruption can be common and compliance with anti-bribery laws may conflict with local customs and practices. Our global operations face the risk of unauthorized payments or offers being made by employees, consultants, sales agents and other business partners outside of our control or without our authorization. It is our policy to implement safeguards (including mandatory training) to prohibit these practices by our employees and business partners with respect to our operations. However, irrespective of these safeguards, or as a result of monitoring compliance with such safeguards, it is possible that we or certain other parties may discover or receive information at some point that certain employees, consultants, sales agents, or other business partners may have engaged in corrupt conduct for which we might be held responsible. Violations of the FCPA or other foreign anti-corruption laws may result in restatements of, or irregularities in, our financial statements as well as severe criminal or civil sanctions, and we may be subject to other liabilities, which could negatively affect our business, operating results and financial condition. In some cases, companies that violate the FCPA may be debarred by the U.S. government and/or lose their U.S. export privileges. Changes in anti-corruption laws or enforcement priorities could also result in increased compliance requirements and related costs which could adversely affect our business, financial condition and results of operations. In addition, the U.S. or other governments may seek to hold us liable for FCPA violations or violations of other anti-corruption laws committed by companies in which we invest or that we acquired or will acquire.

In the past, we have had net losses and we may report net losses in the future, which could negatively impact our ability to achieve or sustain profitability.

In the past, we have had net losses and we cannot assure you that we will achieve or sustain profitability on a quarterly or annual basis in the future.  If we cannot maintain profitability, the value of our stock price may be impacted.

Our effective income tax rate may fluctuate, which may adversely affect our operations, earnings and earnings per share.

Our effective income tax rate is influenced by our projected profitability in the various taxing jurisdictions in which we operate. The global nature of our business increases our tax risks. In addition, for various reasons, revenue authorities in many of the jurisdictions in which we operate are known to have become more active in their tax collection activities. Changes in the distribution of profits and losses among taxing jurisdictions may have a significant impact on our effective income tax rate, which in turn could have an adverse effect on our net income and earnings per share. The application of tax laws in various taxing jurisdictions, including the United States, is subject to interpretation, and tax authorities in various jurisdictions may have diverging and sometimes conflicting interpretations of the application of tax laws. Changes in tax laws or tax rulings, in the United States or other tax jurisdictions in which we operate, could materially impact our effective tax rate.

Factors that may affect our effective income tax rate include, but are not limited to:

 

the requirement to exclude from our quarterly worldwide effective income tax calculations losses in jurisdictions where no income tax benefit can be recognized;

 

actual and projected full year pre-tax income, including differences between actual and anticipated income before taxes in various jurisdictions;

 

changes in tax laws, or in the interpretation or application of tax laws, in various taxing jurisdictions;

 

audits or other challenges by taxing authorities;

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the establishment of valuation allowances against a portion or all of certain deferred income tax assets if we determined that it is more likely than not that future income tax benefits will not be realized; and

 

changes in the relative mix and size of clinical trials and staffing levels in various tax jurisdictions.

These changes may cause fluctuations in our effective income tax rate that could adversely affect our results of operations and cause fluctuations in our earnings and earnings per share.

On December 22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act” (TCJA) that significantly reforms the Internal Revenue Code of 1986, as amended. The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system. We continue to examine the impact this tax reform legislation may have on our business. The impact of this tax reform on holders of our common stock is uncertain and could be adverse. This Annual Report on Form 10-K does not discuss any such tax legislation or the manner in which it might affect purchasers of our common stock. We urge our stockholders to consult with their legal and tax advisors with respect to such legislation and the potential tax consequences of investing in our common stock.

Governmental authorities may question our intercompany transfer pricing policies or change their laws in a manner that could increase our effective tax rate or otherwise harm our business.

As a U.S. company doing business in international markets through subsidiaries, we are subject to foreign tax and intercompany pricing laws, including those relating to the flow of funds between the parent and subsidiaries. Tax authorities in the United States and in foreign markets closely monitor our corporate structure and how we account for intercompany fund transfers. If tax authorities challenge our corporate structure, transfer pricing mechanisms or intercompany transfers, our operations may be negatively impacted and our effective tax rate may increase. Tax rates vary from country to country and if regulators determine that our profits in one jurisdiction should be increased, we might not be able to fully utilize all foreign tax credits that are generated, which would increase our effective tax rate. Additionally, the Organization for Economic Cooperation and Development, or OECD, has issued certain proposed guidelines regarding base erosion and profit sharing. Once these guidelines are formally adopted by the OECD, it is possible that separate taxing jurisdictions may also adopt some form of these guidelines. In such case, we may need to change our approach to intercompany transfer pricing in order to maintain compliance under the new rules. Our effective tax rate may increase or decrease depending on the current location of global operations at the time of the change. Finally, we might not always be in compliance with all applicable customs, exchange control, Value Added Tax and transfer pricing laws despite our efforts to be aware of and to comply with such laws. In such case, we may need to adjust our operating procedures and our business could be adversely affected.

If we are unable to recruit suitable investigators and enroll patients for our customers’ clinical trials, our clinical development business may suffer.

The recruitment of investigators and patients for clinical trials is essential to our business. Investigators are typically located at hospitals, clinics or other sites and supervise the administration of the investigational drug, biologic or device to patients during the course of a clinical trial. Patients typically include people from the communities in which the clinical trials are conducted. Our clinical development business could be adversely affected if we are unable to attract suitable and willing investigators or patients for clinical trials on a consistent basis. For example, if we are unable to engage investigators to conduct clinical trials as planned or enroll sufficient patients in clinical trials, we may need to expend additional funds to obtain access to resources or else be compelled to delay or modify the clinical trial plans, which may result in additional costs to us. These considerations might result in our being unable to successfully achieve our projected development timelines, or potentially even lead to the termination of ongoing clinical trials or development of a product.

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Our clinical development services could subject us to potential liability that may adversely affect our results of operations and financial condition.

Our business involves the testing of new drugs, biologics and medical devices on patients in clinical trials. Our involvement in the clinical trial and development process creates a risk of liability for personal injury to or death of patients, particularly for those with life-threatening illnesses, resulting from adverse reactions to the products administered during testing or after regulatory approval. For example, we may be sued in the future by individuals alleging personal injury due to their participation in clinical trials and seeking damages from us under a variety of legal theories. If we are required to pay damages or incur defense costs in connection with any personal injury claim that is outside the scope of indemnification agreements we have with our customers, if any indemnification agreement is not performed in accordance with its terms or if our liability exceeds the amount of any applicable indemnification limits or available insurance coverage, our business, financial condition, results of operations, cash flows or reputation could be materially and adversely affected. We might also not be able to obtain adequate insurance or indemnification for these types of risks at reasonable rates in the future.

We also contract with institutions and physicians to serve as investigators in conducting clinical trials. Investigators are typically located at hospitals, clinics or other sites and supervise the administration of the investigational products to patients during the course of a clinical trial. If the investigators or study staff commit errors or make omissions during a clinical trial that result in harm to trial patients, or patients suffer harm with a delayed onset after a clinical trial is completed and the product has obtained regulatory approval, claims for personal injury or products liability damages may result. Additionally, if the investigators engage in fraudulent or negligent behavior, trial data may be compromised, which may require us to repeat the clinical trial or subject us to liability or regulatory action. We do not believe we are legally responsible for the medical care rendered by such third party investigators, and we would vigorously defend any claims brought against us. However, it is possible we could be found liable for claims with respect to the actions of third party investigators and the institutions at which clinical trials may be conducted.

Some of our services involve direct interaction with clinical trial patients and operation of a Phase I clinical facility, which could create potential liability that may adversely affect our results of operations and financial condition.

We operate a facility where Phase I clinical trials are conducted, which ordinarily involve testing an investigational drug, biologic or medical device on a limited number of individuals to evaluate its safety, determine a safe dosage range and identify side effects. Failure to operate such a facility and clinical trials in accordance with FDA, DEA and other applicable regulations could result in disruptions to our operations. Additionally, we face risks associated with adverse events resulting from the administration of such drugs, biologics and medical devices and the professional malpractice of medical care providers. We also directly employ nurses and other trained employees who assist in implementing the testing involved in our clinical trials, such as drawing blood from subjects. Any professional malpractice or negligence by such investigators, nurses or other employees could potentially result in liability to us in the event of personal injury to or death of a subject in clinical trials. This liability, particularly if it were to exceed the limits of any indemnification agreements and insurance coverage we may have, may adversely affect our financial condition, results of operations and reputation.

Our insurance may not cover all of our indemnification obligations and other liabilities associated with our operations.

We maintain insurance designed to provide coverage for ordinary risks associated with our operations and our ordinary indemnification obligations, which we believe to be customary for our industry. The coverage provided by such insurance may not be adequate for all claims we may make or may be contested by our insurance carriers. If our insurance is not adequate or available to pay liabilities associated with our operations, or if we are unable to purchase adequate insurance at reasonable rates in the future, our business, financial condition, results of operations or cash flows may be materially adversely impacted.

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Exchange rate fluctuations may have a material adverse effect on our business, financial condition, results of operations or cash flows.

As a large portion of our net revenue and expenses are denominated in currencies other than the U.S. dollar and our financial statements are reported in U.S. dollars, changes in foreign currency exchange rates could significantly affect our financial condition, results of operations and cash flows.

The revenue and expenses of our foreign operations are generally denominated in local currencies and translated into U.S. dollars for financial reporting purposes. Accordingly, exchange rate fluctuations will affect the translation of foreign results into U.S. dollars for purposes of reporting our consolidated results.

We are subject to foreign currency transaction risk for fluctuations in exchange rates during the period of time between the consummation and cash settlement of a transaction. We earn revenue from our service contracts over a period of several months and, in some cases, over several years. Accordingly, exchange rate fluctuations during such periods may affect our profitability with respect to such contracts.

Additionally, the majority of our global contracts are denominated in U.S. dollars or Euros, while the currency used to fund our operating costs in foreign countries is denominated in various different currencies. Fluctuations in the exchange rates of the currencies we use to contract with our customers and the currencies in which we incur cost to complete those contracts can have a significant impact on our results of operations.

We may limit these risks through exchange rate fluctuation provisions stated in our service contracts. We have not, however, mitigated all of our foreign currency transaction risk, and we may experience fluctuations in financial results from our operations outside the United States and foreign currency transaction risk associated with our service contracts.

Our relationships with existing or potential customers who are in competition with each other may adversely impact the degree to which other customers or potential customers use our services, which may adversely affect our results of operations.

The biopharmaceutical industry is highly competitive, with companies each seeking to persuade payors, providers and patients that their drug therapies are more cost-effective than competing therapies marketed or being developed by competing firms. In addition to the adverse competitive interests that biopharmaceutical companies have with each other, these companies also have adverse interests with respect to drug selection, coverage and reimbursement with other participants in the healthcare industry, including payors and providers. Biopharmaceutical companies also compete to be first to the market with new drug therapies. We regularly provide services to biopharmaceutical companies who compete with each other, and we sometimes provide services to such customers regarding competing drugs in development. Our existing or future relationships with our biopharmaceutical customers may deter other biopharmaceutical customers from using our services or, in certain instances, may result in our customers seeking to place limits on our ability to serve their competitors and other industry participants. In addition, our further expansion into the broader healthcare market may adversely impact our relationships with biopharmaceutical customers, and such customers may elect not to use our services, reduce the scope of services that we provide to them or seek to place restrictions on our ability to serve customers in the broader healthcare market with interests that are adverse to theirs. Any loss of customers or reductions in the level of revenues from a customer could have a material adverse effect on our business, financial condition, results of operations or cash flows.

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If we are unable to successfully integrate potential future acquisitions, our business, financial condition, results of operations and cash flows could be adversely affected.

We anticipate that a portion of our future growth may come from targeted acquisitions to expand our current capabilities and service offerings. The success of any acquisition will depend upon, among other things, our ability to effectively integrate acquired personnel, operations, products and technologies into our business and to retain the key personnel and customers of our acquired businesses. In addition, we may be unable to identify suitable acquisition opportunities or obtain any necessary financing on commercially acceptable terms. We may also spend time and money investigating and negotiating with potential acquisition targets but not complete the transaction. Any acquisition could involve other risks, including, among others, the assumption of additional liabilities and expenses, difficulties and expenses in connection with integrating the acquired companies and achieving the expected benefits, issuances of potentially dilutive securities or interest-bearing debt, loss of key employees of the acquired companies, transaction expenses, diversion of management’s attention from other business concerns and, with respect to the acquisition of international companies, the inability to overcome differences in international business practices, language and customs. Our failure to successfully integrate potential future acquisitions could have an adverse effect on our business, financial condition, results of operations and cash flows.

We have a significant amount of goodwill and intangible assets on our balance sheet, and our results of operations may be adversely affected if we fail to realize the full value of our goodwill and intangible assets.

Our goodwill was recorded in connection with Cinven’s acquisition of us in 2014. In accordance with US GAAP, goodwill and indefinite lived intangible assets are not amortized, but are subject to a periodic impairment evaluation. We assess the realizability of our indefinite lived intangible assets and goodwill annually and conduct an interim evaluation whenever events or changes in circumstances, such as operating losses or a significant decline in earnings associated with the acquired business or asset, indicate that these assets may be impaired. In addition, we review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets might not be recoverable. If indicators of impairment are present, we evaluate the carrying value in relation to estimates of future discounted cash flows. Our ability to realize the value of the goodwill and intangible assets will depend on the future cash flows of our businesses. The carrying amount of the goodwill could be impaired if there is a downturn in our business or our industry or other factors that affect the fair value of our business, in which case a charge to earnings would become necessary. If we are not able to realize the value of the goodwill and intangible assets, we may be required to incur material charges relating to the impairment of those assets.

Our operations involve the use and disposal of hazardous substances and waste which can give rise to liability that could adversely impact our financial condition.

We conduct activities that have involved, and may continue to involve, the controlled use of hazardous materials and the creation of hazardous substances, including medical waste and other highly regulated substances. As a result, our operations pose the risk of accidental contamination or injury caused by the release of these materials and/or the creation of hazardous substances, including medical waste and other highly regulated substances. In the event of such an accident, we could be held liable for damages and cleanup costs which, to the extent not covered by existing insurance or indemnification, could harm our business. In addition, other adverse effects could result from such liability, including reputational damage resulting in the loss of additional business from certain customers.

The failure of third parties to provide us critical support services could materially adversely affect our business, financial condition, results of operations, cash flows or reputation.

We depend on third parties for support services vital to our business. Such support services include, but are not limited to, laboratory services, third-party transportation and travel providers, technology providers, freight forwarders and customs brokers, drug depots and distribution centers, suppliers or contract manufacturers of drugs for patients participating in clinical trials and providers of licensing agreements, maintenance contracts or other services. In addition, we also rely on third-party CROs and other contract clinical personnel for clinical services either in regions where we have limited resources, or in cases where demand cannot be met by our internal staff. The failure of any of these third parties to adequately provide us critical support services could have a material adverse effect on our business, financial condition, results of operations, cash flows or reputation.

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We have only a limited ability to protect our intellectual property rights, and these rights are important to our success.

Our success depends, in part, upon our ability to develop, use and protect our proprietary methodologies, analytics, systems, technologies and other intellectual property. Existing laws of the various countries in which we provide services or solutions offer only limited protection of our intellectual property rights, and the protection in some countries may be very limited. We rely upon a combination of trade secrets, confidentiality policies, nondisclosure, invention assignment and other contractual arrangements, and copyright, trademark and trade secret laws, to protect our intellectual property rights. These laws are subject to change at any time and certain agreements may not be fully enforceable, which could further restrict our ability to protect our innovations. Our intellectual property rights may not prevent competitors from independently developing services similar to or duplicative of ours. Further, the steps we take in this regard might not be adequate to prevent or deter infringement or other misappropriation of our intellectual property by competitors, former employees or other third parties, and we might not be able to detect unauthorized use of, or take appropriate and timely steps to enforce, our intellectual property rights. Enforcing our rights might also require considerable time, money and oversight, and we may not be successful in enforcing our rights.

The results of the United Kingdom’s referendum on withdrawal from the European Union may have a negative effect on global economic conditions, financial markets and our business.

In June 2016, a majority of voters in the United Kingdom (UK) elected to withdraw from the European Union, or the EU, in a national referendum (commonly referred to as Brexit). The referendum was advisory, and the terms of any withdrawal are subject to a negotiation period that could last at least two years after the government of the UK formally initiates a withdrawal process. Nevertheless, the referendum has created significant uncertainty about the future relationship between the UK and the EU, including with respect to the laws and regulations that will apply as the UK determines which EU laws to replace or replicate in the event of a withdrawal. The referendum has also given rise to calls for the governments of other EU member states to consider withdrawal. These developments, or the perception that any of them could occur, have had and may continue to have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets. Any of these factors could depress economic activity and restrict our access to capital, which could have a material adverse effect on our business, financial condition and results of operations and reduce the price of our common stock.

Due to the fact that we have operations located within the UK, Brexit could negatively impact our operations resulting primarily from (a) operational disruptions due to changes in the manner in which people and products are moved between the UK and EU following Brexit; (b) changes in the regulatory regime governing in clinical trials in the UK once the UK is no longer under umbrella EU scheme; and (c) potential price increases for supplies purchased by our UK businesses from companies located in the EU or elsewhere. These risks would be heightened in the event that the UK and the EU are unable to reach a mutually satisfactory exit agreement before the current deadline of March 29, 2019.

Further, due to Brexit, the value of the British Pound Sterling incurred significant fluctuations. Additionally, further actions related to Brexit may occur in the future. If the value of the British Pound Sterling continues to incur similar fluctuations, unfavorable exchange rate changes may negatively affect the value of our operations and businesses located in the UK, as translated to our reporting currency, the United States Dollar, in accordance with US GAAP, which may impact the revenue and earnings we report. For more information with respect to Exchange Rate risk applicable to us, please see Part 2 Item 7A. "Market Risk Disclosures" elsewhere in this Annual Report on Form 10-K. Continued fluctuations in the British Pound Sterling may also result in the imposition of price adjustments by EU-based suppliers to our UK businesses, as those suppliers seek to compensate for the changes in value of the British Pound Sterling as compared to the European Euro. In addition, a so-called “Hard Brexit,” where no formal agreement is made between the EU and UK prior to the UK’s exit, could result in a continued deflation of the British Pound Sterling; additional increases in prices, fees, taxes or tariffs applicable to goods that are bought and sold between the UK and Europe, and a negative impact on end markets in the UK as a result of declines in consumer sentiment or decreased immigration rates into the UK.  Any of these results could have a material adverse effect on the business, revenues and financial condition of our UK and European operations.

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Potential future investments in our customers’ businesses or products could have a negative impact on our financial results.

We have in the past and may in the future enter into arrangements with our customers or other drug, biologic or medical device companies in which we take on payment risk by making strategic investments in our customers or other drug companies, providing flexible payment terms or fee financing to customers or other companies, or entering into other risk sharing arrangements on trial execution. Our financial results would be adversely affected if the amount realized from any such risk sharing arrangement was less than the value of our services under the contract related to such arrangement.  

We act as legal representative for some clients.

We act as the legal representative for certain clients in certain jurisdictions. As we believe that acting as legal representative of clients exposes us to a higher risk of liability, this service is provided subject to our policy and requires certain preconditions to be met. The preconditions relate to obtaining specific insurance commitments and indemnities from the client to cover the nature of the exposure. However, there is no guarantee that the specific insurance will be available and provide cover or that a client will fulfil its obligations in relation to their indemnity.

Our operations might be affected by the occurrence of a natural disaster or other catastrophic event.

We depend on our customers, investigators, laboratories and other facilities for the continued operation of our business. Although we have contingency plans in place for natural disasters or other catastrophic events, these events, including terrorist attacks, pandemic flu, hurricanes, floods and ice and snow storms, could nevertheless disrupt our operations or those of our customers, investigators and collaboration partners, which could also affect us. Even though we carry business interruption insurance policies and typically have provisions in our contracts that protect us in certain events, we might suffer losses as a result of business interruptions that exceed the coverage available under our insurance policies or for which we do not have coverage. Any natural disaster or catastrophic event affecting us or our customers, investigators or collaboration partners could have a significant negative impact on our operations and financial performance.

Risks Relating to Our Industry

Outsourcing trends in the biopharmaceutical industry and changes in aggregate expenditures and R&D budgets could adversely affect our operating results and growth rate.

Our revenues depend on the level of R&D expenditures, size of the drug development pipelines and outsourcing trends of the biopharmaceutical industry, including the amount of such R&D expenditures that is outsourced and subject to competitive bidding among CROs. Accordingly, economic factors and industry trends that affect biopharmaceutical companies affect our business. For example, if biopharmaceutical companies become less able to access capital in the future, they may commit less capital to our services going forward. Also, biopharmaceutical companies continue to seek long-term strategic collaborations with global CROs with favorable pricing terms. Many of our competitors seek out these collaborations, while we generally do not. If our competitors can successfully enter into these collaborations, it may reduce the share of the biopharmaceutical outsourcing business that we might otherwise be positioned to capture.

In addition, if the biopharmaceutical industry reduces its outsourcing of clinical trials or such outsourcing fails to grow at projected or expected rates, or at all, our business, financial condition, results of operations and cash flows could be materially and adversely affected. We may also be negatively impacted by consolidation and other factors in the biopharmaceutical industry, which may slow decision making by our customers, result in the delay or cancellation of existing projects, cause reductions in overall R&D expenditures or lead to increased pricing pressures. Further, in the event that one of our customers combines with a company that is using the services of one of our competitors, the combined company could decide to use the services of that competitor or another provider. All of these events could adversely affect our business, financial condition, cash flows or results of operations.

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We face intense competition in many areas of our business and, if we do not compete effectively, our business may be harmed.

The CRO industry is highly competitive. We often compete for business with other CROs as well as internal development departments at some of our customers, some of which could be considered large CROs in their own right. We also compete with universities and teaching hospitals. Some of these competitors have greater financial resources and a wider range of service offerings over a greater geographic area than we do. If we do not compete successfully, our business will suffer. The industry is highly fragmented, with numerous smaller specialized companies and a handful of full-service companies with global capabilities similar to ours. Increased competition has led to price and other forms of competition, such as acceptance of less favorable contract terms, which could adversely affect our operating results. In recent years, our industry has experienced consolidation. This trend is likely to produce more competition from the resulting larger companies. Further, certain of our key competitors are private and, therefore, they do not contend with the cost pressures of being a public company. We compete with both large CROs and mid-sized CROs, and have increasingly faced more competition from larger CROs. Our ability to continue to grow and perform effectively will directly impact our success against our competitors. In addition, there are few barriers to entry for smaller specialized companies considering entering the industry. Because of their size and focus, small CROs might compete effectively against larger companies such as us, especially in lower cost geographic areas, which could have a material adverse effect on our business.

We may be affected by healthcare reform and potential additional regulatory reforms, which may adversely impact the biopharmaceutical industry or otherwise reduce the need for our services or negatively impact our profitability.

Numerous government bodies are considering or have adopted various healthcare reforms and may undertake, or are in the process of undertaking, efforts to control growing healthcare costs through legislation, regulation and voluntary agreements with healthcare providers and biopharmaceutical companies, including many of our customers. By way of example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the Affordable Care Act, was signed into law, which, among other things, expanded, over time, health insurance coverage, imposed health industry cost containment measures, enhanced remedies against healthcare fraud and abuse, added new transparency requirements for healthcare and health insurance industries, imposed new taxes and fees on pharmaceutical and medical device manufacturers, added new requirements for certain applicable drug and device manufacturers to disclose payments to physicians, including principal investigators, and imposed additional health policy reforms, any of which may significantly impact the biopharmaceutical industry. We are uncertain as to the full effects of these reforms on our business and are unable to predict what legislative proposals, if any, will be adopted in the future. If regulatory cost containment efforts limit the profitability of new drugs, our customers may reduce their R&D expenditures, which could reduce the business they outsource to us. Similarly, if regulatory requirements for product testing are relaxed or harmonized across jurisdictions, or simplified drug approval procedures are adopted, the demand for our services could decrease.

Government bodies may also adopt healthcare legislation or regulations that are more burdensome than existing regulations. For example, product safety concerns and recommendations by the Drug Safety Oversight Board could change the regulatory environment for drug products, and new or heightened regulatory requirements may increase our expenses or limit our ability to offer some of our services. Additionally, new or heightened regulatory requirements may have a negative impact on the ability of our customers to conduct industry sponsored clinical trials, which could reduce the need for our services. These developments and the lack of clarity regarding future healthcare policies and regulations have created significant uncertainty that could adversely affect our business, financial condition, cash flows or results of operations.

Consolidation in the biopharmaceutical industry could lead to a reduction in our revenues.

The biopharmaceutical and CRO industries are currently undergoing a period of increased merger activity. Several large biopharmaceutical companies have recently completed mergers and acquisitions that will consolidate the outsourcing trends and R&D expenditures into fewer companies, and many larger and medium sized biopharmaceutical companies have been acquiring smaller biopharmaceutical companies. As a result of this and future consolidations, our customer diversity may decrease and our business may be adversely affected.

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If we fail to comply with federal, state and foreign healthcare laws, including fraud and abuse laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.

Even though we do not order healthcare services or bill directly to Medicare, Medicaid or other third party payors, certain federal and state healthcare laws and regulations pertaining to fraud and abuse are applicable to our business. We could be subject to healthcare fraud and abuse laws of both the federal government and the states in which we conduct our business. Because of the breadth of these laws and the narrowness of available statutory and regulatory exceptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws. If we or our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, imprisonment and the curtailment or restructuring of our operations, any of which could materially adversely affect our ability to operate our business and our financial results.

Laws and regulations regarding the protection of personal data could result in increased risks of liability or increased cost to us or could limit our service offerings.

The confidentiality, collection, use and disclosure of personal data, including clinical trial patient-specific information, are subject to governmental regulation generally in the country in which the personal data was collected or used. For example, U.S. federal regulations under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations, including the Privacy and Security Rules, or collectively, HIPAA, generally require individuals’ written authorization, in addition to any required informed consent, before protected health information may be used for research and such regulations specify standards for de-identifications and for limited data sets. We may also be subject to applicable state privacy and security laws and regulations in states in which we operate. Two of our subsidiaries, Medpace Clinical Pharmacology, LLC and C-MARC, LLC, are covered entities under HIPAA. Further, because of amendments to the HIPAA Privacy and Security Rules that were promulgated on January 25, 2013, known as the Omnibus Final Rule, service providers to covered entities under HIPAA, known as business associates, are now directly subject to HIPAA. There are some instances where we may be a HIPAA “business associate” of a “covered entity,” meaning that we may be directly liable for any breaches of protected health information and other HIPAA violations. We are also liable contractually under any business associate agreements we have signed with covered entities. If we are determined to be a business associate, we would be subject to HIPAA’s enforcement scheme, which, as amended, can result in up to $1.5 million in annual civil penalties for each HIPAA violation. A single breach incident can result in multiple violations of the HIPAA standards, meaning that penalties could be in excess of $1.5 million. In addition, the Federal Civil Penalties Inflation Adjustment Improvement Act of 2015 required all federal agencies to adjust their civil monetary penalties to inflation, no later than August 1, 2016. As a result, the minimum annual penalties for each HIPPA violation which occurs later than February 17, 2009 is now $1.7 million.

HIPAA also authorizes state attorneys general to file suit on behalf of their residents for violations. Courts are able to award damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of action allowing individuals to file suit against us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care cases in state civil suits such as those for negligence or recklessness in the misuse or breach of protected health information. In addition, HIPAA mandates that the Secretary of the U.S. Department of Health and Human Services conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance with the HIPAA privacy and security standards, and Phase two of these audits, focusing on business associates has begun.

In the EU, personal data includes any information that relates to an identified or identifiable natural person with health information carrying additional obligations, including obtaining the explicit consent from the individual for collection, use or disclosure of the information. In addition, we are subject to EU rules with respect to export of such data out of the EU. Such data export rules are constantly changing, for example, following a decision of the European Court of Justice in October 2015, transferring personal data to U.S. companies like us that had certified as a member of the EU-U.S. Safe Harbor Scheme was declared invalid and the other methods to permit transfer are now under review. In July 2016, the European Commission approved the EU-U.S. Privacy Shield, which replaces the U.S. Safe Harbor Scheme. The United States, the EU and its member states, and other countries where we have

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operations, such as Singapore and Russia, continue to issue new privacy and data protection rules and regulations that relate to personal data and health information. Failure to comply with certain certification/registration and annual re-certification/registration provisions associated with these data protection and privacy regulations and rules in various jurisdictions, or to resolve any serious privacy or security complaints, could subject us to regulatory sanctions, criminal prosecution or civil liability. Federal, state and foreign governments may propose or have adopted additional legislation governing the collection, possession, use or dissemination of personal data, such as personal health information, and personal financial data as well as security breach notification rules for loss or theft of such data. Additional legislation or regulation of this type might, among other things, require us to implement new security measures and processes or bring within the legislation or regulation de-identified health or other personal data, each of which may require substantial expenditures or limit our ability to offer some of our services. Additionally, if we violate applicable laws, regulations or duties relating to the use, privacy or security of personal data, we could be subject to civil liability or criminal prosecution, be forced to alter our business practices and suffer reputational harm. The laws in the EU are under reform and from early 2018 onwards, we will be subject to the requirements of the General Data Protection Regulation, or GDPR, because we are processing data in the EU. The GDPR increases the deadline for data breach notifications, imposes additional obligations when we process personal data on behalf of our customers, including in relation to security measures, and increases administrative burdens on companies processing personal data. If we do not comply with our obligations under the GDPR we could be exposed to significant fines of up to 20 million EUR or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher.

Our business could be harmed from the loss or suspension of a license or imposition of a fine or penalties under, or future changes in, or interpretations of, the law or regulations of the Clinical Laboratory Improvement Act of 1967, and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), or those of other national, state or local agencies in the U.S. and other countries where we operate laboratories.

The commercial laboratory testing industry is subject to extensive U.S. regulation, and many of these statutes and regulations have not been interpreted by the courts. CLIA extends federal oversight to virtually all clinical laboratories operating in the U.S. by requiring that they be certified by the federal government or by a federally approved accreditation agency. The sanction for failure to comply with CLIA requirements may be suspension, revocation or limitation of a laboratory’s CLIA certificate, which is necessary to conduct business, as well as significant fines and/or criminal penalties. In addition, we are subject to regulation under state law. State laws may require that laboratories and/or laboratory personnel meet certain qualifications, specify certain quality controls or require maintenance of certain records. We also operate laboratories outside of the U.S. and are subject to laws governing our laboratory operations in the other countries where we operate.

Applicable statutes and regulations could be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that would adversely affect our business. Potential sanctions for violation of these statutes and regulations include significant fines and the suspension or loss of various licenses, certificates and authorizations, which could have a material adverse effect on our business. In addition, compliance with future legislation could impose additional requirements on us, which may be costly.

The biopharmaceutical industry has a history of patent and other intellectual property litigation, and we might be involved in costly intellectual property lawsuits.

The biopharmaceutical industry has a history of intellectual property litigation, and these lawsuits will likely continue in the future. Accordingly, even without wrongdoing on our part, we may face patent infringement suits by companies that have patents for similar business processes or other suits alleging infringement of their intellectual property rights. Legal proceedings relating to intellectual property could be expensive, take significant time and divert management’s attention from other business concerns, regardless of the outcome of the litigation. If we do not prevail in an infringement lawsuit brought against us, we might have to pay substantial damages, and we could be required to stop the infringing activity or obtain a license to use technology on unfavorable terms. Further, our customers could be similarly exposed to intellectual property suits and the resulting economic and operational strain defending such claims could negatively impact such customers’ ability to fund or continue ongoing clinical trials on which we are working.

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Actions by regulatory authorities or customers to limit the scope of or withdraw an approved drug, biologic or medical device from the market could result in a loss of revenue.

Government regulators have the authority, after approving a drug, biologic or medical device, to limit its indication for use by requiring additional labeled warnings or to withdraw the product’s approval for its approved indication based on safety or other concerns. Similarly, customers may act to voluntarily limit the availability of approved products or withdraw them from the market after we begin our work. If we are providing services to customers for products that are limited in availability or withdrawn, we may be required to narrow the scope of or terminate our services with respect to such products, which would prevent us from earning the full amount of net revenue anticipated under the related service contracts.

If we do not keep pace with rapid technological changes, our services may become less competitive or obsolete.

The biopharmaceutical industry generally, and drug development and clinical research more specifically, are subject to rapid technological changes. Our current competitors or other businesses might develop technologies or services that are more effective or commercially attractive than, or render obsolete, our current or future technologies and services. If our competitors introduce superior technologies or services and if we cannot make enhancements to remain competitive, our competitive position would be harmed. If we are unable to compete successfully, we may lose customers or be unable to attract new customers, which could lead to a decrease in our revenue and have a material adverse effect on our financial condition.

Circumstances beyond our control could cause the CRO industry to suffer reputational or other harm that could result in an industry-wide reduction in demand for CRO services, which could harm our business.

Demand for our services may be affected by perceptions of our customers regarding the CRO industry as a whole. For example, other CROs could engage in conduct that could render our customers less willing to do business with us or any CRO. Likewise, a widely reported injury to clinical trial participants could result in negative perceptions of clinical trial activity, thereby adversely impacting our industry. One or more CROs could engage in or fail to detect malfeasance, such as inadequately monitoring sites, producing inaccurate databases or analysis, falsifying patient records, and performing incomplete lab work, or take other actions that would reduce the confidence of our customers in the CRO industry. As a result, the willingness of biopharmaceutical companies to outsource R&D services to CROs could diminish and our business could thus be harmed materially by events outside our control.

 

Risks Relating to Our Indebtedness

Our indebtedness could adversely affect our financial condition and prevent us from fulfilling our debt obligations and may otherwise restrict our activities.

Our indebtedness could adversely affect our financial condition and thus make it more difficult for us to satisfy our obligations with respect to our Senior Secured Credit Facilities. If our cash flow is not sufficient to service our debt and adequately fund our business, we may be required to seek further additional financing or refinancing or dispose of assets. We might not be able to influence any of these alternatives on satisfactory terms or at all. Our indebtedness could also:

 

increase our vulnerability to adverse general economic, industry or competitive developments;

 

require us to dedicate a more substantial portion of our cash flows from operations to payments on our indebtedness, thereby reducing the availability of our cash flows to fund working capital, investments, acquisitions, capital expenditures, and other general corporate purposes;

 

limit our ability to make required payments under our existing contractual commitments, including our existing long-term indebtedness;

 

limit our ability to fund a change of control offer;

 

require us to sell certain assets;

 

restrict us from making strategic investments, including acquisitions or cause us to make non-strategic divestitures;

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limit our flexibility in planning for, or reacting to, changes in market conditions, our business and the industry in which we operate;

 

place us at a competitive disadvantage compared to our competitors that have less debt;

 

cause us to incur substantial fees from time to time in connection with debt amendments or refinancings;

 

increase our exposure to rising interest rates because our borrowings are at variable interest rates; and

 

limit our ability to borrow additional funds or to borrow on terms that are satisfactory to us.

For more information about our indebtedness, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Indebtedness” of Part II of this Annual Report on Form 10-K and Note 8 to our audited consolidated financial statements included in Item 8 of Part II of this Annual Report on Form 10-K.

Despite our current level of indebtedness, we may incur more debt and undertake additional obligations. Incurring such debt or undertaking such additional obligations could further exacerbate the risks to our financial condition.

Although the credit agreement governing the Senior Secured Credit Facilities contains restrictions on our incurrence of additional indebtedness, these restrictions are subject to a number of qualifications and exceptions and the indebtedness incurred in compliance with these restrictions could increase. To the extent new debt is added to our current debt levels, the risks to our financial condition would increase.

While the credit agreement governing the Senior Secured Credit Facilities also contains restrictions on our ability to make loans and investments, these restrictions are subject to a number of qualifications and exceptions, and the investments incurred in compliance with these restrictions could be substantial.

Covenant restrictions under our Senior Secured Credit Facilities may limit our ability to operate our business.

The agreement governing our Senior Secured Credit Facilities contains covenants that may restrict our ability to, among other things:

 

create, incur or assume any lien upon any of our property, assets or revenue;

 

make or hold certain investments;

 

incur or assume any indebtedness;

 

merge, dissolve, liquidate or consolidate with or into another person;

 

make certain dispositions of property or other assets (including sale leaseback transactions);

 

declare or make certain restricted payments, including dividends;

 

enter into certain transactions with affiliates;

 

prepay subordinated debt;

 

enter into burdensome agreements;

 

engage in any material line of business substantially different from our currently conducted business; or

 

change our fiscal year.

In addition, we are required to report compliance with two financial covenants that are tested at the end of each fiscal quarter. We are required to maintain a ratio of consolidated funded indebtedness minus unrestricted cash and cash equivalents (in the aggregate not to exceed $50 million and to include not more than $25 million of foreign unrestricted cash and cash equivalents) to consolidated EBITDA for the most recent four fiscal quarter period not to exceed 4.00:1.00; provided that we shall be permitted to increase the ratio to 4.50:1.00 in connection with any permitted acquisition or any other acquisition consented to by the Administrative Agent and the Required Lenders (each as defined in the Senior Secured Credit Agreement) with total cash consideration in excess of $25 million.  Such increase shall be applicable for the fiscal quarter in which such acquisition is consummated and the three consecutive test periods thereafter.  We are also required to maintain a ratio of consolidated EBITDA to consolidated interest expense, in each case for the most recent four fiscal quarter period, of not less than 3.00:1.00. 

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Although the covenants in our Senior Secured Credit Facilities are subject to various exceptions, we cannot assure you that these covenants will not adversely affect our ability to finance future operations or capital needs or to engage in other activities that may be in our best interest. In addition, in certain circumstances, our long-term debt requires us to maintain a specified financial ratio and satisfy certain financial condition tests, which may require that we take action to reduce our debt or to act in a manner contrary to our business objectives. A breach of any of these covenants could result in a default under our Senior Secured Credit Facilities. If an event of default under our Senior Secured Credit Facilities occurs, the lenders thereunder could elect to declare all amounts outstanding thereunder, together with accrued interest, to be immediately due and payable. In such case, we might not have sufficient funds to repay all the outstanding amounts. In addition, our Senior Secured Credit Facilities are secured by first priority security interests on substantially all of our assets, including the capital stock of certain of our subsidiaries. If an event of default under our Senior Secured Credit Facilities occurs, the lenders thereunder could exercise their rights under the related security documents. Any acceleration of amounts due under the Senior Secured Credit Facilities or the substantial exercise by the lenders of their rights under the security documents would likely have a material adverse effect on us.

We may not be able to generate sufficient cash to service all of our indebtedness, and may be forced to take other actions to satisfy our obligations under our indebtedness that may not be successful.

Our ability to satisfy our debt obligations will depend upon, among other things:

 

our future financial and operating performance, which will be affected by prevailing economic conditions and financial, business, regulatory and other factors, many of which are beyond our control; and

 

the future availability of borrowings under our Senior Secured Credit Facilities, which depends on, among other things, our complying with the covenants in those facilities.

We cannot assure you that our business will generate sufficient cash flow from operations, or that future borrowings will be available to us under our Senior Secured Credit Facilities or otherwise, in an amount sufficient to fund our liquidity needs.

If our cash flows and capital resources are insufficient to service our indebtedness, we may be forced to reduce or delay capital expenditures, sell assets, seek additional capital or restructure or refinance our indebtedness. These alternative measures may not be successful and may not permit us to meet our scheduled debt service obligations. Our ability to restructure or refinance our debt will depend on the condition of the capital markets and our financial condition at such time. Any refinancing of our debt could be at higher interest rates and may require us to comply with more onerous covenants, which could further restrict our business operations. In addition, the terms of existing or future debt agreements, may restrict us from adopting some of these alternatives. In the absence of such operating results and resources, we could face substantial liquidity problems and might be required to dispose of material assets or operations to meet our debt service and other obligations. We may not be able to consummate those dispositions for fair market value or at all, and any proceeds that we could realize from any such dispositions may not be adequate to meet our debt service obligations then due.

Interest rate fluctuations may affect our results of operations and financial condition.

Because our debt is variable-rate debt, fluctuations in interest rates could have a material effect on our business. As a result, we may incur higher interest costs if interest rates increase. These higher interest costs could have a material adverse impact on our financial condition and the levels of cash we maintain for working capital.

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We are dependent upon our lenders for financing to execute our business strategy and meet our liquidity needs. If our lenders are unable to fund borrowings under their credit commitments or we are unable to borrow, it could negatively impact our business.

During periods of volatile credit markets, there is risk that any lenders, even those with strong balance sheets and sound lending practices, could fail or refuse to honor their legal commitments and obligations under existing credit commitments, including but not limited to, extending credit up to the maximum permitted by a credit facility. If our lenders are unable to fund borrowings under their revolving credit commitments or we are unable to borrow (such as having insufficient capacity under our borrowing base), it could be difficult in such environments to obtain sufficient liquidity to meet our operational needs.

 

Changes in the method of determining London Interbank Offered Rate ("LIBOR"), or the replacement of LIBOR with an alternative reference rate, may adversely affect interest expense related to outstanding debt.

 

Amounts drawn under our Senior Secured Credit Facilities may bear interest rates in relation to LIBOR, depending on our selection of repayment options. On July 27, 2017, the Financial Conduct Authority (“FCA”) in the UK announced that it would phase out LIBOR as a benchmark by the end of 2021. It is unclear whether new methods of calculating LIBOR will be established such that it continues to exist after 2021. The U.S. Federal Reserve is considering replacing U.S. dollar LIBOR with a newly created index called the Broad Treasury Financing Rate, calculated with a broad set of short-term repurchase agreements backed by treasury securities. If LIBOR ceases to exist, we may need to renegotiate the Senior Secured Credit Facilities and may not able to do so with terms that are favorable to us. The overall financial market may be disrupted as a result of the phase-out or replacement of LIBOR. Disruption in the financial market or the inability to renegotiate the Senior Secured Credit Facilities with favorable terms could have a material adverse effect on our business, financial position, and operating results.

 

Downgrades of our credit ratings could adversely affect us.

We can be adversely affected by downgrades of our credit ratings because ratings are a factor influencing our ability to access capital and the terms of any new indebtedness, including covenants and interest rates. Our customers and vendors may also consider our credit profile when negotiating contract terms, and if they were to change the terms on which they deal with us, it could have a material adverse effect on our business, results of operations, cash flows, and financial condition.

Our Senior Secured Credit Facilities contain covenants that may restrict our ability to, among other things, borrow money, pay dividends, make capital expenditures, make strategic acquisitions and effect a consolidation, merger, or disposal of all or substantially all of our assets. Refer to "Risks Related to Our Indebtedness - Covenant restrictions under our Senior Secured Credit Facilities may limit our ability to operate our business" for further details on our covenant restrictions.

Risks Relating to Ownership of Our Common Stock

Our Chief Executive Officer and founder controls a substantial amount of our outstanding common stock and his interests may be different from or conflict with those of our other shareholders.

As of December 31, 2018, Dr. August J. Troendle, our Chief Executive Officer and founder, through his direct ownership of 603,702 shares of our common stock and his beneficial ownership of 8,151,125 shares of our common stock held by Medpace Investors LLC (“Medpace Investors”), controls approximately 24.5% of the outstanding shares of our common stock. Upon a distribution of our common stock held by Medpace Investors, our Chief Executive Officer would receive approximately 83.3% of such distributed shares. Accordingly, Dr. Troendle is able to exert a significant degree of influence or actual control over our management and affairs and control all corporate actions requiring shareholder approval, irrespective of how our other shareholders may vote, including:

 

the election and removal of directors and the size of our board of directors, or the Board;

 

any amendment of our articles of incorporation or bylaws; or

 

the approval of mergers and other significant corporate transactions, including a sale of substantially all of our assets.

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Moreover, Dr. Troendle’s share ownership may also adversely affect the trading price for our common stock to the extent investors perceive disadvantages in owning shares of a company with a significant shareholder.

Our anti-takeover provisions could prevent or delay a change in control of our company, even if such change in control would be beneficial to our shareholders.

Provisions of our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law could discourage, delay or prevent a merger, acquisition or other change in control of our company, even if such change in control would be beneficial to our shareholders. These provisions include:

 

authorizing the issuance of “blank check” preferred stock that could be issued by our Board to increase the number of outstanding shares and thwart a takeover attempt;

 

establishing a classified Board so that not all members of our Board are elected at one time;

 

the removal of directors only for cause;

 

prohibiting the use of cumulative voting for the election of directors;

 

limiting the ability of shareholders to call special meetings or amend our bylaws;

 

requiring all shareholder actions to be taken at a meeting of our shareholders and not by written consent; and

 

establishing advance notice and duration of ownership requirements for nominations for election to the Board or for proposing matters that can be acted upon by shareholders at shareholder meetings.

These provisions could also discourage proxy contests and make it more difficult for our shareholders to elect directors of their choosing and cause us to take other corporate actions our shareholders desire. In addition, because our Board is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our shareholders to replace current members of our management team.

In addition, the Delaware General Corporation Law, or the DGCL, to which we are subject, prohibits us, except under specified circumstances, from engaging in any mergers, significant sales of stock or assets or business combinations with any shareholder or group of shareholders who owns at least 15% of our common stock for three years following their becoming the owner of 15% of our common stock.

Our non-employee directors may acquire interests and positions that could present potential conflicts with our and our shareholders’ interests.

Our non-employee directors make investments in companies and may, from time to time, acquire and hold interests in businesses that compete directly or indirectly with us. Our non-employee directors may also pursue, for their own accounts, acquisition opportunities that may be complementary to our business, and as a result, those acquisition opportunities might not be available to us. Our organizational documents contain provisions renouncing any interest or expectancy held by our non-employee directors in corporate opportunities. Accordingly, the interests of our non-employee directors may supersede ours, causing our non-employee directors and their affiliates to compete against us or to pursue opportunities instead of us, for which we have no recourse. Such actions on the part of our non-employee directors and inaction on our part could have a material adverse effect on our business, financial condition, results of operations and cash flows.

 

We are party to transactions with related persons that may increase the risk of allegations of conflicts of interest, and such allegations may impair our ability to realize the benefits we expect from these transactions.

 

Due to the relationships among us and certain related persons, the agreements or other transactions we have entered into with them are considered related person transactions. Our agreements or transactions with related persons may not be on terms as favorable to us as they would have been if they had been negotiated among unrelated persons. For additional information on related person transactions involving us, see the “Certain Relationships” section in our Proxy Statement for our 2018 Annual Meeting of Stockholders. While our Related Person Transaction Policy and Procedures requires our Audit Committee’s consideration of all relevant facts and circumstances, including a

- 39 -


determination of whether the transaction has terms comparable to those that could be obtained in an arm’s length transaction, the potential for a conflict of interest exists and such related persons may have conflicts of interest, or the appearance of conflicts of interest, with respect to matters involving or affecting us and the related person. Moreover, we are subject to the risk that our stockholders may challenge any such related person transactions and the agreements entered into as part of them. If such a challenge were to be successful, we might not realize the benefits expected from the transactions being challenged. Moreover, any such challenge could result in substantial costs and a diversion of our management’s attention, could have a material adverse effect on our reputation, business and growth and could adversely affect our ability to realize the benefits expected from the transactions, whether or not the allegations have merit or are substantiated.

We may issue shares of preferred stock in the future, which could make it difficult for another company to acquire us or could otherwise adversely affect holders of our common stock, which could depress the price of our common stock.

Our amended and restated certificate of incorporation authorizes us to issue one or more series of preferred stock. Our Board has the authority to determine the preferences, limitations and relative rights of the shares of preferred stock and to fix the number of shares constituting any series and the designation of such series, without any further vote or action by our shareholders. Our preferred stock could be issued with voting, liquidation, dividend and other rights superior to the rights of our common stock. The potential issuance of preferred stock may delay or prevent a change in control of us, discourage bids for our common stock at a premium to the market price, and materially and adversely affect the market price and the voting and other rights of the holders of our common stock.

The provision of our amended and restated certificate of incorporation requiring exclusive venue in the Court of Chancery in the State of Delaware for certain types of lawsuits may have the effect of discouraging lawsuits against our directors and officers.

Our amended and restated certificate of incorporation requires, to the fullest extent permitted by law, that (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our shareholders, (iii) any action asserting a claim against us arising pursuant to any provision of the DGCL or our amended and restated certificate of incorporation or the bylaws or (iv) any action asserting a claim against us governed by the internal affairs doctrine will have to be brought only in the Court of Chancery in the State of Delaware. Although we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.

Failure to establish and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and stock price.

As a public company, we are required to comply with the rules of the U.S. Securities and Exchange Commission, or the SEC, implementing Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and are therefore required to make a formal assessment of the effectiveness of our internal control over financial reporting for that purpose. We are required to comply with the SEC’s rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act, which require management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of controls over financial reporting. As an emerging growth company, our independent registered public accounting firm is not required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 until the later of the year following our first annual report required to be filed with the SEC or the date we are no longer an emerging growth company. At such time, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our controls are documented, designed or operating.

To comply with the requirements of being a public company, we have undertaken various actions, and may need to take additional actions, such as implementing new internal controls and procedures and hiring additional accounting or internal audit staff. Testing and maintaining internal control can divert our management’s attention from other matters that are important to the operation of our business. Additionally, when evaluating our internal control over financial reporting, we may identify material weaknesses that will cause us to be out of compliance with the requirements of Section 404. If we are unable to comply with the requirements of Section 404 or assert that our

- 40 -


internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting once we are no longer an emerging growth company, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could be negatively affected, and we could become subject to investigations by NASDAQ, the SEC or other regulatory authorities, which could require additional financial and management resources.

We have identified a material weakness in our internal control over financial reporting related to ASC 606 that, if not remediated, could result in a material misstatement in our financial statements.

Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. As disclosed in Item 9A of this Annual Report, management has identified a material weakness in our internal control over financial reporting related to the implementation of ASU No. 2014-09 “Revenue from Contracts with Customers” (Topic 606). A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our consolidated financial statements will not be prevented or detected on a timely basis. As a result of this material weakness, our management concluded that our internal control over financial reporting was not effective as of December 31, 2018. Although we have developed and initiated a remediation plan designed to address the material weakness we have identified, this plan may not be fully implemented in a timely or effective manner. Deficiencies, including any material weakness, in our internal control over financial reporting that have not been remediated or that may occur in the future could result in misstatements of our results of operations, restatements of our financial statements, a decline in our stock price, or otherwise materially adversely affect our business, reputation, results of operations, financial condition, or liquidity.

We have incurred and will continue to incur significant costs as a result of operating as a public company, and our management will devote substantial time to new compliance initiatives.

As a publicly traded company, we have incurred and will continue to incur significant legal, accounting and other expenses that we were not required to incur prior to our initial public offering (“IPO”). Further, these costs may increase after we are no longer an “emerging growth company” as defined under the JOBS Act. In addition, compliance with new and changing laws, regulations and standards relating to corporate governance and public disclosure, including the Dodd-Frank Wall Street Reform and Customer Protection Act, or the Dodd-Frank Act, and the rules and regulations promulgated and to be promulgated thereunder, as well as under the Sarbanes-Oxley Act, and the rules and regulations of the SEC, has increased and will continue to increase our legal and financial compliance costs and make some activities more difficult, time-consuming or costly. For example, the Exchange Act requires us, among other things, to file annual, quarterly and current reports with respect to our business and operating results. Being a public company and being subject to new rules and regulations has made it more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to continue to obtain coverage. As such, we expect to continue to incur additional annual expenses of $3.0 million to $4.0 million related to operating as a public company. These factors may therefore strain our resources, divert management’s attention, and affect our ability to attract and retain qualified members of our Board and adversely affect our operating margins.

Furthermore, the need to continue to establish the corporate infrastructure demanded of a public company may divert management’s attention from implementing our growth strategy, which could prevent us from improving our business, results of operations and financial condition. We have made, and will continue to make, changes to our internal controls and procedures for financial reporting and accounting systems to meet our reporting obligations as a publicly traded company. However, the measures we take may not be sufficient to satisfy our obligations as a publicly traded company.

- 41 -


Our operating results and share price may be volatile, and the market price of our common stock may drop.

Our quarterly operating results have fluctuated, and are likely to fluctuate in the future. In addition, securities markets worldwide have experienced, and are likely to continue to experience, significant price and volume fluctuations. This market volatility, as well as general economic, market or political conditions, could subject the market price of shares of our common stock to wide price fluctuations regardless of our operating performance. The public market for our common stock is new and the trading price of shares of our common stock may fluctuate in response to various factors, including:

 

market conditions in the broader stock market or in the healthcare sector;

 

developments affecting biopharmaceutical companies generally or biopharmaceutical research and development outsourcing;

 

actual or anticipated fluctuations in our quarterly financial and operating results;

 

introduction of new products or services by us or our competitors;

 

the public’s reaction to our press releases, our other public announcements and our filings with the SEC;

 

changes in, or failure to meet, earnings estimates or recommendations by research analysts who track our common stock or the stock of other companies in our industries;

 

strategic actions by us, our customers or our competitors, such as acquisitions or restructurings;

 

changes in accounting standards, policies, guidance, interpretations or principles;

 

issuance of new or changed securities analysts’ reports or recommendations or termination of coverage of our common stock by securities analysts;

 

sales, or anticipated sales, of large blocks of our stock;

 

the granting or exercise of employee stock options;

 

volume of trading in our common stock;

 

additions or departures of key personnel;

 

regulatory or political developments;

 

litigation and governmental investigations;

 

changing economic conditions;

 

defaults on our indebtedness;

 

exchange rate fluctuations; and

 

the other factors listed in this “Risk Factors” section.

These and other factors, many of which are beyond our control, may cause our operating results and the market price and demand for shares of our common stock to fluctuate substantially. While we believe that operating results for any particular quarter are not necessarily a meaningful indication of future results, fluctuations in our quarterly operating results could limit or prevent investors from readily selling their shares and may otherwise negatively affect the market price and liquidity of shares of our common stock. In addition, in the past, when the market price of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation against the company that issued the stock. If any of our shareholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit. Such a lawsuit could also divert the time and attention of our management from our business, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.

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Shares of our common stock may be sold into the market in the near future. This could cause the market price of our common stock to drop significantly, even if our business is doing well.

In September 2018, Medpace Investors, a noncontrolling shareholder and an affiliate of the Company that is owned by employees of the Company and managed by our chief executive officer, distributed 744,385 shares of our common stock in-kind to the holders of incentive units in Medpace Investors. As the restrictions on the transfer of these shares will expire in March 2019 these shares will be available for sale in the open market.

In connection with the IPO, we filed a registration statement on Form S-8 under the Securities Act to register all shares of common stock issued or issuable under the 2016 Incentive Award Plan, which became effective upon filing. Accordingly, shares registered under such registration statement will be available for sale in the open market following the expiration of the applicable lock-up period. The registration statement on Form S-8 covers 6,000,000 shares of our common stock.

Because we have no current plans to pay regular cash dividends on our common stock, our shareholders may not receive any return on investment unless they sell their common stock for a price greater than that which they paid for it.

We do not anticipate paying any regular cash dividends on our common stock for the foreseeable future. Any decision to declare and pay dividends in the future will be made at the discretion of our Board and will depend on, among other things, our results of operations, financial condition, cash requirements, contractual restrictions and other factors that our Board may deem relevant. In addition, our ability to pay dividends is, and may continue to be, limited by covenants of existing and any future outstanding indebtedness we or our subsidiaries incur, including under our existing Senior Secured Credit Facilities. Therefore, any return on investment in our common stock is solely dependent upon the appreciation of the price of our common stock on the open market, which may not occur.

We are a holding company and rely on dividends and other payments, advances and transfers of funds from our subsidiaries to meet our obligations and pay any dividends.

We have no direct operations and no significant assets other than ownership of 100% of the capital stock of our subsidiaries. Because we conduct our operations through our subsidiaries, we depend on those entities for dividends and other payments to generate the funds necessary to meet our financial obligations, and to pay any dividends with respect to our common stock. Legal and contractual restrictions in our Senior Secured Credit Facilities and other agreements which may govern future indebtedness of our subsidiaries, as well as the financial condition and operating requirements of our subsidiaries, may limit our ability to obtain cash from our subsidiaries. The earnings from, or other available assets of, our subsidiaries might not be sufficient to pay dividends or make distributions or loans to enable us to pay any dividends on our common stock or other obligations. Any of the foregoing could materially and adversely affect our business, financial condition, results of operations and cash flows.

If securities or industry analysts do not publish research or reports about our business, if they adversely change their recommendations regarding our common stock or if our results of operations do not meet their expectations, our share price and trading volume could decline.

The trading market for shares of our common stock is influenced by the research and reports that industry or securities analysts publish about us or our business. We do not have any control over these analysts. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our share price or trading volume to decline. Moreover, if one or more of the analysts who cover us downgrade our stock, or if our results of operations do not meet their expectations, our share price could decline.

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We are an “emerging growth company” and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.

The JOBS Act provides that, so long as a company qualifies as an “emerging growth company,” it will, among other things:

 

be exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that its independent registered public accounting firm provide an attestation report on the effectiveness of its internal control over financial reporting;

 

be exempt from the “say on pay” and “say on golden parachute” advisory vote requirements of the Dodd-Frank Act;

 

be exempt from certain disclosure requirements of the Dodd-Frank Act relating to compensation of its executive officers and be permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Exchange Act; and

 

be exempt from any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotations or a supplement to the auditor’s report on the financial statements.

We currently take advantage of each of the exemptions described above. In connection with our IPO, we irrevocably elected not to take advantage of the extension of time to comply with new or revised financial accounting standards available under Section 107(b) of the JOBS Act. We cannot predict if investors will find our common stock less attractive if we elect to rely on these exemptions, or if taking advantage of these exemptions would result in less active trading or more volatility in the price of our common stock.

We will be an emerging growth company until the earliest of (1) the last day of the fiscal year (a) following August 10, 2021, the fifth anniversary of our initial public offering, or (b) in which we have total annual gross revenues of at least $1.07 billion, or (2) when we are deemed to be a large accelerated filer, which means the market value of our Common Stock that is held by non-affiliates exceeds $700 million as of the last business day of our prior second fiscal quarter, or (3) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period. While we could be an emerging growth company up to the last day of the fiscal year following the fifth anniversary of the completion of our IPO we expect, assuming the price per share of our Common Stock on June 30, 2019 is approximately $26.02 or higher, we will no longer be an emerging growth company at the end of the fiscal year ending December 31, 2019.

FINRA has commenced a review of the trading of our common stock surrounding the July 30, 2018 announcement of our second quarter 2018 financial results. We cannot predict the outcome of the investigation. Potential negative outcomes could adversely affect our ability to raise future financing and the investigation itself could distract our management, both of which could increase the risk that you would suffer a loss on your investment.

We have been advised that the Financial Industry Regulatory Authority (“FINRA”) is conducting a review of trading in Medpace Holdings common stock surrounding the July 30, 2018 announcement of our second quarter 2018 financial results. We have been responding to FINRA’s request for information and intend to continue to cooperate in the investigation.

Although we cannot, at this time, assess either the duration or the likely outcome or consequences of this investigation, any FINRA action that adversely affects us could also adversely affect the trading price of our common stock. In addition, to the extent that the FINRA investigation distracts our management from pursuing our business plan, our results and the trading price of our common stock could be adversely affected.

Item 1B. Unresolved Staff Comments.

None.

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Item 2. Properties.

As of December 31, 2018, we had 39 leased commercial locations in 28 countries across North America, Europe, Asia/Pacific, South America and Africa. We also own lab and office space in Leuven, Belgium. Most of these facilities consist solely of office space; however, we have five laboratories located across four facilities and a logistics warehouse. Our principal executive offices are located on a corporate campus in Cincinnati, Ohio consisting of four buildings totaling approximately 350,000 square feet. The leases for three buildings in our Cincinnati site expire in 2022, 2027 and 2027, respectively. We own the other building. Additionally, we entered into a lease for an additional corporate office, which is currently under construction, on the corporate campus in Cincinnati, Ohio. This lease consists of approximately 249,000 square feet and expires in 2040. None of our leases are individually material to our business model and all have either options to renew or are located in major markets with what we believe are adequate opportunities to continue business operations on terms satisfactory to us.

We are party to legal proceedings incidental to our business and may become subject to additional legal proceedings in the future. While the outcome of these matters could differ from management’s expectations, we do not believe that the resolution of these matters, individually and in the aggregate, is reasonably likely to have a material adverse effect to our consolidated financial statements. Litigation is subject to inherent uncertainties. See Note 9 “Commitments, Contingencies and Guarantees—Legal Proceedings” to our consolidated financial statements included in Item 8 of Part II in this Annual Report on Form 10-K.

Item 4. Mine Safety Disclosures

Not applicable.

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PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information for Common Stock

On August 11, 2016, our common stock began trading on the NASDAQ Global Select Market under the symbol “MEDP”. Prior to that time, there was no public market for our common stock.

Holders of Record

On February 22, 2019, there were approximately 102 shareholders of record of our common stock. Because many of the shares of our common stock are registered in “nominee” or “street” names, we believe that the total number of beneficial owners is considerably higher.

Dividend Policy

We have not paid any dividends to date, nor do we have current plans to pay any cash dividends on our common stock for the foreseeable future and instead intend to retain earnings, if any, for future operations, expansion and debt repayment. However, in the future, subject to the factors described below and our future liquidity and capitalization, we may change this policy and choose to pay dividends.

We are a holding company which does not conduct any business operations of our own. As a result, our ability to pay cash dividends on our common stock is dependent upon cash dividends and distributions and other transfers from our subsidiaries. The ability of our subsidiaries to pay dividends is currently restricted by the terms of our Senior Secured Credit Facilities and may be further restricted by any future indebtedness we or they incur.

In addition, under Delaware law, our Board may declare dividends only to the extent of our surplus (which is defined as total assets at fair market value minus total liabilities, minus statutory capital) or, if there is no surplus, out of our net profits for the then current and/or immediately preceding fiscal year.

Any future determination to declare dividends will be at the discretion of our Board and will take into account:

 

restrictions in our debt instruments, including our Senior Secured Credit Facilities;

 

general economic business conditions;

 

our net income, financial condition and results of operations;

 

our capital requirements;

 

our prospects;

 

the ability of our operating subsidiaries to pay dividends and make distributions to us;

 

legal restrictions; and

 

such other factors as our Board may deem relevant.

See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Indebtedness” of Part II of this Annual Report on Form 10-K and Note 8 “Debt” to our audited consolidated financial statements in Item 8 of Part II on this Annual Report on Form 10-K for restrictions on our ability to pay dividends.

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Recent Sales of Unregistered Securities

 

Date

 

Equity Plan

 

Number of Stock Options Exercised

 

 

Exercise Price

 

 

Approximate Aggregate Purchase Price

 

January 1, 2018

 

2014 Equity Incentive Plan

 

 

259

 

 

$

14.41

 

 

$

3,700

 

January 9, 2018

 

2014 Equity Incentive Plan

 

 

3,704

 

 

 

14.41

 

 

 

53,400

 

January 13, 2018

 

2014 Equity Incentive Plan

 

 

1,750

 

 

 

14.41

 

 

 

25,200

 

January 27, 2018

 

2014 Equity Incentive Plan

 

 

4,324

 

 

 

14.41

 

 

 

62,300

 

January 29, 2018

 

2014 Equity Incentive Plan

 

 

8,111

 

 

 

14.41

 

 

 

116,900

 

February 1, 2018

 

2014 Equity Incentive Plan

 

 

265

 

 

 

14.41

 

 

 

3,800

 

February 22, 2018

 

2014 Equity Incentive Plan

 

 

750

 

 

 

14.41

 

 

 

10,800

 

February 23, 2018

 

2014 Equity Incentive Plan

 

 

347

 

 

 

14.41

 

 

 

5,000

 

February 28, 2018

 

2014 Equity Incentive Plan

 

 

1,852

 

 

 

14.41

 

 

 

26,700

 

February 28, 2018

 

2014 Equity Incentive Plan

 

 

370

 

 

 

16.20

 

 

 

6,000

 

February 28, 2018

 

2014 Equity Incentive Plan

 

 

2,592

 

 

 

18.23

 

 

 

47,300

 

March 1, 2018

 

2014 Equity Incentive Plan

 

 

3,278

 

 

 

14.41

 

 

 

47,200

 

March 5, 2018

 

2014 Equity Incentive Plan

 

 

2,962

 

 

 

16.20

 

 

 

48,000

 

March 8, 2018

 

2014 Equity Incentive Plan

 

 

3,333

 

 

 

14.41

 

 

 

48,000

 

March 13, 2018

 

2014 Equity Incentive Plan

 

 

253

 

 

 

14.41

 

 

 

3,600

 

March 16, 2018

 

2014 Equity Incentive Plan

 

 

1,300

 

 

 

14.41

 

 

 

18,700

 

March 20, 2018

 

2014 Equity Incentive Plan

 

 

600

 

 

 

14.41

 

 

 

8,600

 

March 23, 2018

 

2014 Equity Incentive Plan

 

 

1,000

 

 

 

14.41

 

 

 

14,400

 

March 26, 2018

 

2014 Equity Incentive Plan

 

 

1,111

 

 

 

14.41

 

 

 

16,000

 

April 2, 2018

 

2014 Equity Incentive Plan

 

 

1,481

 

 

 

16.20

 

 

 

24,000

 

April 3, 2018

 

2014 Equity Incentive Plan

 

 

555

 

 

 

16.20

 

 

 

9,000

 

April 5, 2018

 

2014 Equity Incentive Plan

 

 

370

 

 

 

16.20

 

 

 

6,000

 

April 10, 2018

 

2014 Equity Incentive Plan

 

 

333

 

 

 

14.41

 

 

 

4,800

 

May 2, 2018

 

2014 Equity Incentive Plan

 

 

278

 

 

 

16.20

 

 

 

4,500

 

May 3, 2018

 

2014 Equity Incentive Plan

 

 

666

 

 

 

14.41

 

 

 

9,600

 

May 7, 2018

 

2014 Equity Incentive Plan

 

 

1,000

 

 

 

14.41

 

 

 

14,400

 

May 14, 2018

 

2014 Equity Incentive Plan

 

 

2,500

 

 

 

14.41

 

 

 

36,000

 

May 16, 2018

 

2014 Equity Incentive Plan

 

 

592

 

 

 

14.41

 

 

 

8,500

 

May 16, 2018

 

2014 Equity Incentive Plan

 

 

1,416

 

 

 

16.20

 

 

 

22,900

 

May 18, 2018

 

2014 Equity Incentive Plan

 

 

3,611

 

 

 

14.41

 

 

 

52,000

 

May 24, 2018

 

2014 Equity Incentive Plan

 

 

1,944

 

 

 

14.41

 

 

 

28,000

 

May 24, 2018

 

2014 Equity Incentive Plan

 

 

1,111

 

 

 

16.20

 

 

 

18,000

 

June 4, 2018

 

2014 Equity Incentive Plan

 

 

4,166

 

 

 

14.41

 

 

 

60,000

 

June 4, 2018

 

2014 Equity Incentive Plan

 

 

1,389

 

 

 

16.20

 

 

 

22,500

 

June 10, 2018

 

2014 Equity Incentive Plan

 

 

463

 

 

 

14.41

 

 

 

6,700

 

June 11, 2018

 

2014 Equity Incentive Plan

 

 

5,591

 

 

 

14.41

 

 

 

80,600

 

June 11, 2018

 

2014 Equity Incentive Plan

 

 

200

 

 

 

16.20

 

 

 

3,200

 

June 12, 2018

 

2014 Equity Incentive Plan

 

 

2,222

 

 

 

14.41

 

 

 

32,000

 

June 13, 2018

 

2014 Equity Incentive Plan

 

 

892

 

 

 

14.41

 

 

 

12,900

 

June 14, 2018

 

2014 Equity Incentive Plan

 

 

4,444

 

 

 

16.88

 

 

 

75,000

 

June 15, 2018

 

2014 Equity Incentive Plan

 

 

1,462

 

 

 

14.41

 

 

 

21,100

 

June 19, 2018

 

2014 Equity Incentive Plan

 

 

1,388

 

 

 

14.41

 

 

 

20,000

 

June 19, 2018

 

2014 Equity Incentive Plan

 

 

833

 

 

 

16.20

 

 

 

13,500

 

June 21, 2018

 

2014 Equity Incentive Plan

 

 

259

 

 

 

14.41

 

 

 

3,700

 

June 25, 2018

 

2014 Equity Incentive Plan

 

 

740

 

 

 

14.41

 

 

 

10,700

 

June 28, 2018

 

2014 Equity Incentive Plan

 

 

648

 

 

 

14.41

 

 

 

9,300

 

July 3, 2018

 

2014 Equity Incentive Plan

 

 

4,946

 

 

 

14.41

 

 

 

71,300

 

July 9, 2018

 

2014 Equity Incentive Plan

 

 

5,703

 

 

 

14.41

 

 

 

82,200

 

July 30, 2018

 

2014 Equity Incentive Plan

 

 

6,390

 

 

 

16.20

 

 

 

103,500

 

July 30, 2018

 

2014 Equity Incentive Plan

 

 

2,500

 

 

 

14.41

 

 

 

36,000

 

August 2, 2018

 

2014 Equity Incentive Plan

 

 

1,540

 

 

 

14.41

 

 

 

22,200

 

August 6, 2018

 

2014 Equity Incentive Plan

 

 

2,000

 

 

 

14.41

 

 

 

28,800

 

August 8, 2018

 

2014 Equity Incentive Plan

 

 

1,200

 

 

 

14.41

 

 

 

17,300

 

- 47 -


Date

 

Equity Plan

 

Number of Stock Options Exercised

 

 

Exercise Price

 

 

Approximate Aggregate Purchase Price

 

August 10, 2018

 

2014 Equity Incentive Plan

 

 

800

 

 

 

14.41

 

 

 

11,500

 

August 21, 2018

 

2014 Equity Incentive Plan

 

 

1,200

 

 

 

14.41

 

 

 

17,300

 

August 24, 2018

 

2014 Equity Incentive Plan

 

 

5,000

 

 

 

14.41

 

 

 

72,100

 

August 28, 2018

 

2014 Equity Incentive Plan

 

 

750

 

 

 

14.41

 

 

 

10,800

 

September 6, 2018

 

2014 Equity Incentive Plan

 

 

900

 

 

 

18.23

 

 

 

16,400

 

September 7, 2018

 

2014 Equity Incentive Plan

 

 

2,357

 

 

 

14.41

 

 

 

34,000

 

September 14, 2018

 

2014 Equity Incentive Plan

 

 

300

 

 

 

18.23

 

 

 

5,500

 

September 18, 2018

 

2014 Equity Incentive Plan

 

 

556

 

 

 

14.41

 

 

 

8,000

 

September 24, 2018

 

2014 Equity Incentive Plan

 

 

3,703

 

 

 

14.41

 

 

 

53,400

 

September 24, 2018

 

2014 Equity Incentive Plan

 

 

2,778

 

 

 

16.20

 

 

 

45,000

 

October 11, 2018

 

2014 Equity Incentive Plan

 

 

2,332

 

 

 

14.41

 

 

 

33,600

 

October 15, 2018

 

2014 Equity Incentive Plan

 

 

5,555

 

 

 

14.41

 

 

 

80,000

 

October 15, 2018

 

2014 Equity Incentive Plan

 

 

1,944

 

 

 

16.20

 

 

 

31,500

 

October 18, 2018

 

2014 Equity Incentive Plan

 

 

1,552

 

 

 

18.23

 

 

 

28,300

 

October 23, 2018

 

2014 Equity Incentive Plan

 

 

1,852

 

 

 

18.23

 

 

 

33,800

 

October 24, 2018

 

2014 Equity Incentive Plan

 

 

925

 

 

 

14.41

 

 

 

13,300

 

October 29, 2018

 

2014 Equity Incentive Plan

 

 

1,555

 

 

 

14.41

 

 

 

22,400

 

October 30, 2018

 

2014 Equity Incentive Plan

 

 

2,222

 

 

 

14.41

 

 

 

32,000

 

October 30, 2018

 

2014 Equity Incentive Plan

 

 

834

 

 

 

16.20

 

 

 

13,500

 

October 31, 2018

 

2014 Equity Incentive Plan

 

 

1,500

 

 

 

14.41

 

 

 

21,600

 

November 16, 2018

 

2014 Equity Incentive Plan

 

 

8,000

 

 

 

14.41

 

 

 

115,300

 

November 19, 2018

 

2014 Equity Incentive Plan

 

 

851

 

 

 

14.41

 

 

 

12,300

 

December 3, 2018

 

2014 Equity Incentive Plan

 

 

617

 

 

 

14.41

 

 

 

8,900

 

December 7, 2018

 

2014 Equity Incentive Plan

 

 

7,800

 

 

 

14.41

 

 

 

112,400

 

December 10, 2018

 

2014 Equity Incentive Plan

 

 

525

 

 

 

14.41

 

 

 

7,600

 

December 21, 2018

 

2014 Equity Incentive Plan

 

 

6,666

 

 

 

16.88

 

 

 

112,500

 

December 21, 2018

 

2014 Equity Incentive Plan

 

 

3,703

 

 

 

14.41

 

 

 

53,400

 

Total

 

 

 

 

169,771

 

 

 

 

 

 

$

2,542,200

 

All of the forgoing transactions were to employees of the Company and were deemed to be exempt from registration under the Securities Act in reliance upon Rule 701 promulgated under Section 3(b) of the Securities Act as transactions pursuant to benefit plans and contracts relating to compensation.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

None.

Stock Performance Graph

The information included under the heading “Stock Performance Graph” is “furnished” and not “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed to be “soliciting material” subject to Regulation 14A or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act of 1934, as amended.

- 48 -


Our common stock is listed for trading on the NASDAQ under the symbol “MEDP.” The Stock Price Performance Graph set forth below compares the cumulative total shareholder return on our common stock for the period from August 11, 2016 through December 31, 2018, with the cumulative total return of the Nasdaq Composite Index and the Nasdaq Health Care Index over the same period. The comparison assumes $100 was invested on August 11, 2016 in the common stock of Medpace Holdings, Inc., in the Nasdaq Composite Index, and in the Nasdaq Health Care Index and assumes reinvestment of dividends, if any. The stock price performance of the following graph is not necessarily indicative of future stock price performance. Information used in the graph was obtained from the Nasdaq Stock Market, a source believed to be reliable, but we are not responsible for any errors or omissions in such information.

 

 

Equity Compensation Plans

The information required by Part II, Item 5 of the Annual Report on Form 10-K regarding equity compensation plans is incorporated herein by reference to “Part III, Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.”

Item 6. Selected Financial Data

The following tables set forth, for the periods and at the dates indicated, our selected historical consolidated financial data. We have derived the selected consolidated financial data as of December 31, 2018 and 2017, and for the Successor years ended December 31, 2018, 2017 and 2016 from our audited consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K. We have derived the selected consolidated financial data as of December 31, 2016, 2015 and 2014, and for the Successor year ended December 31, 2015, the Successor nine month period ended December 31, 2014 and the Predecessor three month period ended March 31, 2014 from our audited consolidated financial statements not appearing elsewhere in this Annual Report on Form 10-K. Our historical results are not necessarily indicative of the results we may achieve in any future period.

On July 25, 2016, the Board approved, and made legally effective, a 1-for-1.35 reverse stock split of the Company’s common stock. All share, stock option and per share information presented in the consolidated financial statements have been adjusted to reflect the reverse stock split on a retroactive basis for all periods presented. There was no change in the par value of the Company’s common stock.

 

- 49 -


The accompanying consolidated statements of operations, cash flows and shareholders' equity are presented for two periods: “Predecessor” and “Successor”, which relate to the period preceding and succeeding, respectively, the Change in Control as discussed in Note 2 of the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016. The Company refers to the operations of Medpace Holdings, Inc. and subsidiaries for both the Predecessor and Successor periods.

 

 

SUCCESSOR

 

 

 

PREDECESSOR

 

(in thousands except per share data)

YEAR ENDED

DECEMBER 31,

2018 (3)

 

 

YEAR ENDED

DECEMBER 31,

2017

 

 

YEAR ENDED

DECEMBER 31,

2016

 

 

YEAR ENDED

DECEMBER 31,

2015

 

 

NINE MONTH

PERIOD FROM

APRIL 1, 2014

THROUGH

DECEMBER 31,

2014

 

 

 

THREE MONTH

PERIOD FROM

JANUARY 1, 2014

THROUGH

MARCH 31,

2014

 

Consolidated Statements of

   Operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue, net

$

704,589

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

 

$

-

 

Service revenue, net

 

-

 

 

 

386,462

 

 

 

370,621

 

 

 

320,101

 

 

 

219,791

 

 

 

 

70,250

 

Reimbursed out-of-pocket revenue

 

-

 

 

 

49,690

 

 

 

50,961

 

 

 

38,958

 

 

 

28,708

 

 

 

 

7,679

 

Total revenue

 

704,589

 

 

 

436,152

 

 

 

421,582

 

 

 

359,059

 

 

 

248,499

 

 

 

 

77,929

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Direct service costs, excluding depreciation and amortization

 

252,284

 

 

 

211,773

 

 

 

198,510

 

 

 

163,707

 

 

 

117,550

 

 

 

 

38,759

 

Reimbursed out-of-pocket expenses

 

236,775

 

 

 

49,690

 

 

 

50,961

 

 

 

38,958

 

 

 

28,708

 

 

 

 

7,679

 

Total direct costs

 

489,059

 

 

 

261,463

 

 

 

249,471

 

 

 

202,665

 

 

 

146,258

 

 

 

 

46,438

 

Selling, general and administrative

 

75,681

 

 

 

63,357

 

 

 

61,507

 

 

 

56,998

 

 

 

29,465

 

 

 

 

10,203

 

Acquisition and integration

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

9,297

 

 

 

 

12,420

 

Impairment of goodwill

 

-

 

 

 

-

 

 

 

-

 

 

 

9,313

 

 

 

-

 

 

 

 

-

 

Depreciation

 

9,240

 

 

 

8,574

 

 

 

7,442

 

 

 

6,379

 

 

 

4,610

 

 

 

 

1,832

 

Amortization

 

29,561

 

 

 

37,900

 

 

 

50,672

 

 

 

63,142

 

 

 

56,422

 

 

 

 

5,199

 

Total operating expenses

 

603,541

 

 

 

371,294

 

 

 

369,092

 

 

 

338,497

 

 

 

246,052

 

 

 

 

76,092

 

Income from operations

 

101,048

 

 

 

64,858

 

 

 

52,490

 

 

 

20,562

 

 

 

2,447

 

 

 

 

1,837

 

Other (expense) income, net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss on extinguishment of debt

 

-

 

 

 

-

 

 

 

(10,726

)

 

 

-

 

 

 

-

 

 

 

 

-

 

Miscellaneous income (expense), net

 

1,060

 

 

 

(354

)

 

 

(423

)

 

 

(1,133

)

 

 

(301

)

 

 

 

1,213

 

Interest expense, net

 

(8,157

)

 

 

(7,559

)

 

 

(19,384

)

 

 

(27,259

)

 

 

(23,185

)

 

 

 

(3,272

)

Total other expense, net

 

(7,097

)

 

 

(7,913

)

 

 

(30,533

)

 

 

(28,392

)

 

 

(23,486

)

 

 

 

(2,059

)

Income (loss) before income taxes

 

93,951

 

 

 

56,945

 

 

 

21,957

 

 

 

(7,830

)

 

 

(21,039

)

 

 

 

(222

)

Income tax provision (benefit)

 

20,766

 

 

 

17,823

 

 

 

8,532

 

 

 

843

 

 

 

(6,703

)

 

 

 

1,014

 

Net income (loss)

$

73,185

 

 

$

39,122

 

 

$

13,425

 

 

$

(8,673

)

 

$

(14,336

)

 

 

$

(1,236

)

Net income (loss) per share attributable to common shareholders:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

$

2.05

 

 

$

1.00

 

 

$

0.38

 

 

$

(0.28

)

 

$

(0.46

)

 

 

$

(0.05

)

Diluted

$

1.97

 

 

$

0.98

 

 

$

0.37

 

 

$

(0.28

)

 

$

(0.46

)

 

 

$

(0.05

)

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

35,547

 

 

 

39,056

 

 

 

35,690

 

 

 

31,346

 

 

 

30,869

 

 

 

 

25,047

 

Diluted

 

36,912

 

 

 

39,839

 

 

 

36,329

 

 

 

31,346

 

 

 

30,869

 

 

 

 

25,047

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash Flow Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net cash provided by operating activities

$

156,584

 

 

$

97,385

 

 

$

91,732

 

 

$

85,870

 

 

$

61,995

 

 

 

$

13,207

 

Net cash used in investing activities

 

(16,973

)

 

 

(12,237

)

 

 

(13,422

)

 

 

(6,432

)

 

 

(905,992

)

 

 

 

(827

)

Net cash (used in) provided  by financing activities

 

(141,580

)

 

 

(97,828

)

 

 

(58,008

)

 

 

(116,489

)

 

 

900,171

 

 

 

 

(17,968

)

 

 

SUCCESSOR

 

 

 

PREDECESSOR

 

(in thousands)

YEAR ENDED

DECEMBER 31,

2018 (3)

 

 

YEAR ENDED

DECEMBER 31,

2017

 

 

YEAR ENDED

DECEMBER 31,

2016

 

 

YEAR ENDED

DECEMBER 31,

2015

 

 

NINE MONTH

PERIOD FROM

APRIL 1, 2014

THROUGH DECEMBER 31,

2014

 

 

 

THREE MONTH

PERIOD FROM

JANUARY 1, 2014

THROUGH

MARCH 31,

2014

 

Other Financial Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Backlog (at period end) (1)

 

1,057,898

 

 

 

524,402

 

 

 

483,918

 

 

 

429,659

 

 

 

394,023

 

 

 

 

386,047

 

Net new business awards (2)

 

899,445

 

 

 

426,082

 

 

 

426,960

 

 

 

359,538

 

 

 

231,918

 

 

 

 

97,220

 

- 50 -


 

 

SUCCESSOR

 

 

AS OF

 

 

AS OF

 

 

AS OF

 

 

AS OF

 

 

AS OF

 

(Amounts in thousands )

DECEMBER 31,

2018 (3)

 

 

DECEMBER 31,

2017

 

 

DECEMBER 31,

2016

 

 

DECEMBER 31,

2015

 

 

DECEMBER 31,

2014

 

Consolidated Balance Sheet

   Data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

$

23,275

 

 

$

26,485

 

 

$

37,099

 

 

$

14,880

 

 

$

54,285

 

Restricted cash

 

7

 

 

 

7

 

 

 

308

 

 

 

2,857

 

 

 

1,104

 

Accounts receivable billed and unbilled, net:

 

133,449

 

 

 

83,079

 

 

 

79,767

 

 

 

65,088

 

 

 

65,248

 

Working capital

 

(78,912

)

 

 

(62,735

)

 

 

(35,355

)

 

 

(39,296

)

 

 

(319

)

Total assets

 

967,933

 

 

 

950,717

 

 

 

979,105

 

 

 

984,041

 

 

 

1,096,912

 

Total long-term debt, net (including current portion)

 

79,721

 

 

 

221,611

 

 

 

163,642

 

 

 

377,941

 

 

 

491,773

 

Total liabilities

 

378,230

 

 

 

447,187

 

 

 

368,395

 

 

 

570,567

 

 

 

694,942

 

Total shareholders' equity

 

589,703

 

 

 

503,530

 

 

 

610,710

 

 

 

413,474

 

 

 

401,970

 

Total liabilities and shareholders' equity

 

967,933

 

 

 

950,717

 

 

 

979,105

 

 

 

984,041

 

 

 

1,096,912

 

 

 

(1)

Backlog represents anticipated future net revenue from net new business awards that have commenced, but have not been completed. However, because the contracts included in our backlog are generally terminable without cause, we do not believe that our backlog as of any date is necessarily a meaningful predictor of future results.

(2)

Net new business awards are new business awards net of award modifications and cancellations that had been recognized in backlog during the period. New business awards represent the value of anticipated future net revenue that has been awarded during the period that is recognized in backlog. This value is recognized upon the signing of a contract or receipt of a written pre-contract confirmation from a customer that confirms an agreement in principle on budget and scope. New business awards also include contract amendments, or changes in scope, where the customer has provided written authorization for changes in budget and scope or has approved us to perform additional work as of the measurement date. Awards may not be recognized as backlog after consideration of a number of factors, including whether (i) the relevant net revenue is expected only after a pending regulatory hurdle, which might result in cancellation of the study, (ii) the customer funding needed for commencement of the study is not believed to have been secured or (iii) study timelines are uncertain or not well defined. In addition, study amounts that extend beyond a three-year timeline are not included in backlog. The number and amount of new business awards can vary significantly from period to period, and an award’s contractual duration can range from several months to several years based on customer and project specifications.

(3)

The year ended December 31, 2018 is presented on an ASC 606 basis. All other periods are presented on an ASC 605 basis.

 

- 51 -


Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and the notes thereto included elsewhere in this Annual Report on Form 10-K. This item and the related discussion contain forward-looking statements reflecting current expectations that involve risks and uncertainties. Actual results and the timing of events may differ materially from those indicated in such forward-looking statements. Important factors that may cause such differences include, but are not limited to, those discussed under the “Forward-Looking Statements” above and “Item IA. Risk Factors” in Part I of this Annual Report on Form 10-K.

Business Overview

We are one of the world’s leading clinical contract research organizations, or CROs, by revenue, solely focused on providing scientifically-driven outsourced clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics. We differentiate ourselves from our competitors by our disciplined operating model centered on providing full-service Phase I-IV clinical development services and our therapeutic expertise. We believe this combination results in timely and cost-effective delivery of clinical development services for our customers. We believe that we are a partner of choice for small- and mid-sized biopharmaceutical companies based on our ability to consistently utilize our full-service, disciplined operating model to deliver timely and high-quality results for our customers.

We focus on conducting clinical trials across all major therapeutic areas, with particular strength in Cardiology, Metabolic Disease, Oncology, Endocrinology, Central Nervous System, or CNS, Antiviral and Anti-infective, or AVAI, as well as therapeutic expertise in Medical Devices. Our global platform includes approximately 2,900 employees across 36 countries, providing our customers with broad access to diverse markets and patient populations as well as local regulatory expertise and market knowledge.

Change in Controlled Company Status

Prior to August 10, 2018, the Company met the definition of a “controlled company” as defined by Nasdaq rules. A “controlled company” is defined in Nasdaq Rule 5615(c) as a company of which more than 50 percent of the voting power for the election of directors is held by an individual, group or another company. Certain Nasdaq requirements do not apply to a “controlled company”, including requirements that: (i) a majority of its board of directors must be comprised of “independent” directors as defined in Nasdaq’s rules, and (ii) the compensation of officers and the nomination of directors be determined in accordance with specific rules, generally requiring determinations by committees comprised solely of independent directors or in meetings at which only the independent directors are present. On August 10, 2018, the Company’s previously largest shareholder, Cinven Capital Management (V) General Partner Limited (“Cinven”), sold a portion of its shares in a public offering, which resulted in the Company no longer meeting the definition of a “controlled company”.  

Asset Acquisition

In May 2017, the Company acquired out of bankruptcy NephroGenex, Inc. (“Nephrogenex” or the “Debtor”), a publicly-held pharmaceutical company that had previously filed for relief under Chapter 11 of the United States Bankruptcy Code. The Company, which was the largest unsecured creditor of Nephrogenex, entered into an agreement through the bankruptcy process, to exchange its unsecured claim for 100% of the common stock in the post-bankruptcy, debt-free Debtor. The assets of the acquired Debtor consist primarily of tax attributes as well as in-process research and development and other intangible assets.  An analysis by the Company determined that substantially all the fair value of the assets on the date of acquisition is captured in the tax attributes, as the intangible assets account for a relatively immaterial portion of the fair market value of the total assets received. The acquisition of the Debtor was accounted for as an asset purchase.

- 52 -


The Company allocated its consideration paid of $1.2 million, consisting of accounts receivable and unbilled receivables and transaction related costs, on a pro rata basis to the assets acquired based on their respective fair values.  Acquired assets include intangible assets of $0.5 million, deferred tax assets of $22.2 million, consisting of tax effected net operating losses in the amount of $13.5 million, tax effected capitalized research and development expenses of $8.5 million and tax effected federal tax credits of $0.2 million, and deferred tax liabilities of $0.1 million.  The excess amount of fair value received over consideration paid of $21.4 million was recorded as a Deferred credit in the consolidated balance sheets and will be recognized within income tax provision in proportion to the realization of the deferred tax assets and federal tax credits prospectively.

During the fourth quarter of the year ended December 31, 2017, the Deferred tax assets and related Deferred credit balances were revalued due primarily to the impact of tax reform. See Note 12 of the Notes to Consolidated Financial Statements for further discussion of the impact of tax reform on our consolidated financial statements. Additionally, in 2018, the Company disposed of approximately $7.4 million in deferred tax assets and reduced the Deferred credit by approximately $6.9 million as a result of an IRC Section 382 ownership shift that occurred as a result of Cinven’s sales of the Company’s securities. The ownership shift resulted in a limitation in the ability to utilize the acquired tax attributes and resulted in the described asset write-off and reduction of the Deferred credit.

How We Generate Revenue

We earn fees through the performance of services detailed in our customer contracts. Contract scope and pricing is typically based on either a fixed-fee or unit-of-service model, with consideration of activities performed by third parties, as well as ancillary costs necessary to deliver on the contract scope that are reimbursable by our customers. Our contracts can range in duration from a few months to several years. These contracts are individually priced and negotiated based on the anticipated project scope, including the complexity of the project and the performance risks inherent in the project. The majority of our contracts are structured with an upfront fee that is collected at the time of contract signing, and the balance of the fee is collected over the duration of the contract either through an arranged billing schedule or upon completion of certain performance targets or defined milestones.

Revenue, which is distinct from billing and cash receipt, is recognized based on the satisfaction of the individual performance obligations identified in each contract. Substantially all of our customer contracts consist of a single performance obligation, as the promise to transfer the individual services defined in the contracts are not separately identifiable from other promises in the contract, and therefore not distinct.  Our performance obligations are generally satisfied over time and recognized as services are performed.  The progression of our contract performance obligations are measured primarily utilizing the input method of cost to cost.  Cancellation provisions in our contracts allow our customers to terminate a contract either immediately or according to advance notice terms specified within the applicable contract, which is typically 30 days. Contract cancellation may occur for various reasons, including, but not limited to, adverse patient reactions, lack of efficacy, or inadequate patient enrollment. Upon cancellation, we are entitled to fees for services rendered and reimbursable costs incurred through the date of termination, including payment for subsequent services necessary to conclude the study or close out the contract. These fees are typically discussed and agreed upon with the customer and are realized as revenue when we believe the amount can be estimated reliably and its realization is probable.  Changes in revenue from period to period are driven primarily by new business volume and task order execution activity, project cancellations, changes in estimated costs to complete performance obligations, and the mix of active studies during a given period that can vary based on therapeutic area and or study life cycle stage.

Costs and Expenses

Our costs and expenses are comprised primarily of our total direct costs, selling, general and administrative costs, depreciation and amortization and income taxes.

- 53 -


Total Direct Costs

Total direct costs are primarily driven by labor and related employee benefits, but also include contracted third party service related expenses, fees paid to site investigators, reimbursed out of pocket expenses, laboratory supplies and other expenses contributing to service delivery. The other costs of service delivery can include office rent, utilities, supplies and software licenses which are allocated between Total direct costs and selling, general and administrative expenses based on the estimated contribution among service delivery and support function efforts on a percentage basis. Total direct costs are expensed as incurred and are not deferred in anticipation of contracts being awarded or finalization of changes in scope. Total direct costs, as a percentage of net revenue, can vary from period to period due to project labor efficiencies, changes in workforce, compensation/bonus programs and service mix.

Selling, General and Administrative

Selling, general and administrative expenses are primarily driven by compensation and related employee benefits, as well as rent, utilities, supplies, software licenses, professional fees (e.g., legal and accounting expenses), travel, marketing and other operating expenses.

Depreciation

Depreciation is provided on our property and equipment on the straight-line method at rates adequate to allocate the cost of the applicable assets over their estimated useful lives, which is three to five years for computer hardware, software, phone, and medical imaging equipment, five to seven years for furniture and fixtures and other equipment, and thirty to forty years for buildings. Leasehold improvements and deemed assets from landlord building construction are amortized on a straight-line basis over the shorter of the estimated useful life of the improvement or the associated remaining lease term.

Amortization

Amortization relates to finite-lived intangible assets recognized as expense using the straight-line method or using an accelerated method over their estimated useful lives, which range in term from 5 to 15 years. 

Income Tax Provision

Income tax provision consists of federal, state and local taxes on income in multiple jurisdictions.  Our income tax is impacted by the pre-tax earnings in jurisdictions with varying tax rates and any related tax credits that may be available to us.  Our current and future provision for income taxes will vary from statutory rates due to the impact of valuation allowances in certain countries, income tax incentives, certain non-deductible expenses, and other discrete items.

Key Performance Metrics

To evaluate the performance of our business, we utilize a variety of financial and performance metrics. These key measures include net new business awards and backlog.

Net New Business Awards and Backlog

New business awards represent the value of anticipated future net revenue that has been recognized in backlog during the period. This value is recognized upon the signing of a contract or receipt of a written pre-contract confirmation from a customer that confirms an agreement in principle on budget and scope. New business awards also include contract amendments, or changes in scope, where the customer has provided written authorization for changes in budget and scope or has approved us to perform additional work as of the measurement date. Awards may not be recognized as backlog after consideration of a number of factors, including whether (i) the relevant net revenue is expected only after a pending regulatory hurdle, which might result in cancellation of the study, (ii) the customer funding needed for commencement of the study is not believed to have been secured or (iii) study timelines are uncertain or not well defined. In addition, study amounts that extend beyond a three-year timeline are not included in backlog. The number and amount of new business awards can vary significantly from period to period, and an award’s contractual duration can range from several months to several years based on customer and project specifications.

- 54 -


Cancellations arise in the normal course of business and are reflected when we receive written confirmation from the customer to cease work on a contractual agreement. The majority of our customers can terminate our contracts without cause upon 30 days’ notice. Similar to new business awards, the number and amount of cancellations can vary significantly period over period due to timing of customer correspondence and study-specific circumstances.

Net new business awards represent gross new business awards received in a period offset by total cancellations in that period. On an Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”) basis, net new business awards were $899.4 million for the year ended December 31, 2018. On an Accounting Standards Codification Topic 605, Revenue Recognition (“ASC 605”) basis, net new business awards were $581.0 million, $426.1 million and $427.0 million for the years ended December 31, 2018, 2017 and 2016, respectively.

Backlog represents anticipated future net revenue from net new business awards that have commenced, but have not been completed. Reported backlog will fluctuate based on new business awards, changes in the scope of existing contracts, cancellations, revenue recognition on existing contracts and foreign exchange adjustments from non-U.S. dollar denominated backlog. On an ASC 606 basis, as of December 31, 2018, our backlog was $1,057.9 million. On an ASC 605 basis, as of December 31, 2018, our backlog increased by $101.7 million, or 19.4%, to $626.1 million compared to $524.4 million as of December 31, 2017. Included within backlog on an ASC 606 basis as of December 31, 2018 was approximately $580 million to $600 million that we expect to convert to net revenue in 2019, with the remainder expected to convert to net revenue in years after 2019.

On an ASC 605 basis, the effect of foreign currency adjustments on backlog was as follows: unfavorable foreign currency adjustments of $1.1 million for the year ended December 31, 2018; favorable foreign currency adjustments of $3.2 million for the year ended December 31, 2017; and unfavorable foreign currency adjustments of $3.4 million for the year ended December 31, 2016.

Backlog and net new business award metrics may not be reliable indicators of our future period revenue as they are subject to a variety of factors that may cause material fluctuations from period to period. These factors include, but are not limited to, changes in the scope of projects, cancellations, and duration and timing of services provided.

Exchange Rate Fluctuations

The majority of our contracts and operational transactions are U.S. dollar denominated.  The Euro represents the largest foreign currency denomination of our contractual and operational exposure.  As a result, a portion of our revenue and expenses is subject to exchange rate fluctuations. We have translated the Euro into U.S. dollars using the following average exchange rates based on data obtained from www.xe.com:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

2018

 

 

2017

 

 

2016

 

U.S. Dollars per Euro:

 

1.18

 

 

 

1.13

 

 

 

1.11

 

 

- 55 -


Results of Operations

Year Ended December 31, 2018 compared to Year Ended December 31, 2017

 

 

 

As Reported under ASC 606

 

 

Adjustments

 

 

As Revised under

ASC 605

 

 

As Reported under

ASC 605

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

 

(Amounts in thousands, except percentages)

 

2018

 

 

2018

 

 

2018

 

 

2017

 

 

Change

 

 

% Change

 

Revenue, net

 

$

704,589

 

 

$

(704,589

)

 

$

 

 

$

 

 

$

704,589

 

 

 

100.0

%

Service revenue, net

 

 

 

 

 

478,063

 

 

 

478,063

 

 

 

386,462

 

 

 

(386,462

)

 

 

(100.0

)%

Reimbursed out-of-pocket revenue

 

 

 

 

 

71,305

 

 

 

71,305

 

 

 

49,690

 

 

 

(49,690

)

 

 

(100.0

)%

Total revenue

 

 

704,589

 

 

 

(155,221

)

 

 

549,368

 

 

 

436,152

 

 

 

268,437

 

 

 

61.5

%

Direct service costs, excluding depreciation and amortization

 

 

252,284

 

 

 

 

 

 

252,284

 

 

 

211,773

 

 

 

40,511

 

 

 

19.1

%

Reimbursed out-of-pocket expenses

 

 

236,775

 

 

 

(165,470

)

 

 

71,305

 

 

 

49,690

 

 

 

187,085

 

 

 

376.5

%

Total direct costs

 

 

489,059

 

 

 

(165,470

)

 

 

323,589

 

 

 

261,463

 

 

 

227,596

 

 

 

87.0

%

Selling, general and administrative

 

 

75,681

 

 

 

 

 

 

75,681

 

 

 

63,357

 

 

 

12,324

 

 

 

19.5

%

Depreciation

 

 

9,240

 

 

 

 

 

 

9,240

 

 

 

8,574

 

 

 

666

 

 

 

7.8

%

Amortization

 

 

29,561

 

 

 

 

 

 

29,561

 

 

 

37,900

 

 

 

(8,339

)

 

 

(22.0

)%

Total operating expenses

 

 

603,541

 

 

 

(165,470

)

 

 

438,071

 

 

 

371,294

 

 

 

232,247

 

 

 

62.6

%

Income from operations

 

 

101,048

 

 

 

10,249

 

 

 

111,297

 

 

 

64,858

 

 

 

36,190

 

 

 

 

 

Miscellaneous income (expense), net

 

 

1,060

 

 

 

 

 

 

1,060

 

 

 

(354

)

 

 

1,414

 

 

 

 

 

Interest expense, net

 

 

(8,157

)

 

 

 

 

 

(8,157

)

 

 

(7,559

)

 

 

(598

)

 

 

 

 

Income before income taxes

 

 

93,951

 

 

 

10,249

 

 

 

104,200

 

 

 

56,945

 

 

 

37,006

 

 

 

 

 

Income tax provision

 

 

20,766

 

 

 

1,882

 

 

 

22,648

 

 

 

17,823

 

 

 

2,943

 

 

 

 

 

Net income

 

$

73,185

 

 

$

8,367

 

 

$

81,552

 

 

$

39,122

 

 

$

34,063

 

 

 

 

 

 

Total revenue

For the year ended December 31, 2018 total revenue increased by $268.4 million to $704.6 million, from $436.2 million for the year ended December 31, 2017. This was primarily driven by ASC 606 adoption, which resulted in an increase of $155.2 million for the year ended December 31, 2018. The remaining increase was primarily driven by strong activity within the Oncology and other uncategorized therapeutic areas.

Reimbursed out-of-pocket revenue decreased by $49.7 million to $0.0 million for the year ended December 31, 2018, from $49.7 million for the year ended December 31, 2017. This decrease was fully due to ASC 606 adoption.

Total direct costs

Total direct costs increased by $227.6 million, to $489.1 million for the year ended December 31, 2018 from $261.5 million for the year ended December 31, 2017. This was primarily driven by ASC 606 adoption, which resulted in an increase of $165.5 million for year ended December 31, 2018. Reimbursed out-of-pocket expenses, which can fluctuate significantly from period to period based on the timing of the program initiation or closeout, increased $21.6 million for the year ended December 31, 2018. The remaining increase was primarily attributed to higher personnel costs of $25.3 million, service related supply costs of $7.6 million and contracted services costs of $5.1 million in the year ended December 31, 2018, compared to the same period in the prior year, all to support the growth in project activities.

Selling, general and administrative

Selling, general and administrative expenses increased by $12.3 million, to $75.7 million for the year ended December 31, 2018 from $63.4 million for the year ended December 31, 2017. The increase was primarily driven by higher personnel costs of $7.6 million and personnel recruitment costs of $1.4 million in the year ended December 31, 2018, compared to the same period in the prior year, to support growth in project activities. Additionally, there were increases in bad debt expense of $1.1 million and loss on capital asset disposals of $1.2 million in the year ended December 31, 2018, compared to the same period in the prior year.

- 56 -


Depreciation and Amortization

Depreciation and amortization expense decreased by $7.7 million, to $38.8 million for the year ended December 31, 2018 from $46.5 for the year ended December 31, 2017. The decrease in depreciation and amortization was primarily related to the amortization of our definite lived intangible assets, which are amortized on an accelerated basis.

Miscellaneous income (expense), net

Miscellaneous income (expense), net increased by $1.4 million to $1.1 million of income for the year ended December 31, 2018 from $0.4 million of expense for the year ended December 31, 2017. These changes were mainly attributable to foreign exchange gains or losses that arise in connection with the revaluation of short-term inter-company balances between our domestic and international subsidiaries, gains or losses from foreign currency transactions, such as those resulting from the settlement of third-party accounts receivables and payables denominated in a currency other than the local currency of the entity making the payment.

Interest expense, net

Interest expense, net increased by $0.6 million to $8.2 million for the year ended December 31, 2018 from $7.6 million for the year ended December 31, 2017. The increase in interest expense, net was related to higher average outstanding balance under our Senior Secured Revolving Credit Facility (as defined below), as well as a higher effective interest rate as a result of the variable interest rate on the Senior Secured Credit Facilities (as described below).  

Income tax provision

Income tax provision increased by $2.9 million, to $20.8 million for the year ended December 31, 2018 from $17.8 million for the year ended December 31, 2017. The overall effective tax rates for the years ended December 31, 2018 and 2017 were 22.1% and 31.3%, respectively. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as “Tax Cuts and Jobs Act” (TCJA). The effective tax rate for 2018 decreased from 2017 primarily due to the impact from the TCJA. The remaining difference was primarily attributable to the impact of state taxes, domestic and foreign uncertain tax positions and the tax impact associated with acquired tax attributes.  

The 2017 TCJA significantly reforms the Internal Revenue Code of 1986, as amended. The TCJA, among other things, includes a reduction in the U.S. federal tax rate from 35% to 21%, allows for the expensing of capital expenditures and puts into effect the migration from a “worldwide” system of taxation to a territorial system.  The provisional impact on the year ended December 31, 2017 effective tax rate from the TCJA was primarily attributable to a one-time transition tax of $0.6 million on unrepatriated earnings of foreign subsidiaries as well as a tax benefit of $3.4 million related to the revaluation of the Deferred Credit which was partially offset by the revaluation of our deferred tax assets and liabilities and other miscellaneous tax attributes due to the reduction of the U.S. corporate tax rate from 35% to 21%.

We completed our analysis of the TCJA in the fourth quarter of 2018 and adjusted our 2017 provisional estimates to the final amounts. Accordingly, we recorded in our income tax provision a net benefit of $0.1 million, which included an increase in the one-time transition tax of $0.1 million and a tax benefit of $0.2 million related to the revaluation of our deferred tax assets and liabilities. Refer to Note 12 of the Notes to Consolidated Financial Statements for further details.

- 57 -


Year ended December 31, 2017 compared to Year ended December 31, 2016

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

 

 

(Amounts in thousands, except percentages)

 

2017

 

 

2016

 

 

Change

 

 

% Change

 

Revenue, net

 

$

-

 

 

$

-

 

 

$

-

 

 

 

0.0

%

Service revenue, net

 

 

386,462

 

 

 

370,621

 

 

 

15,841

 

 

 

4.3

%

Reimbursed out-of-pocket revenue

 

 

49,690

 

 

 

50,961

 

 

 

(1,271

)

 

 

(2.5

)%

Total revenue

 

 

436,152

 

 

 

421,582

 

 

 

14,570

 

 

 

3.5

%

Direct service costs, excluding

depreciation and amortization

 

 

211,773

 

 

 

198,510

 

 

 

13,263

 

 

 

6.7

%

Reimbursed out-of-pocket expenses

 

 

49,690

 

 

 

50,961

 

 

 

(1,271

)

 

 

(2.5

)%

Total direct costs

 

 

261,463

 

 

 

249,471

 

 

 

11,992

 

 

 

4.8

%

Selling, general and administrative

 

 

63,357

 

 

 

61,507

 

 

 

1,850

 

 

 

3.0

%

Depreciation

 

 

8,574

 

 

 

7,442

 

 

 

1,132

 

 

 

15.2

%

Amortization

 

 

37,900

 

 

 

50,672

 

 

 

(12,772

)

 

 

(25.2

)%

Total operating expenses

 

 

371,294

 

 

 

369,092

 

 

 

2,202

 

 

 

0.6

%

Income from operations

 

 

64,858

 

 

 

52,490

 

 

 

12,368

 

 

 

 

 

Loss on extinguishment of debt

 

 

-

 

 

 

(10,726

)

 

 

10,726

 

 

 

 

 

Miscellaneous expense, net

 

 

(354

)

 

 

(423

)

 

 

69

 

 

 

 

 

Interest expense, net

 

 

(7,559

)

 

 

(19,384

)

 

 

11,825

 

 

 

 

 

Income before income taxes

 

 

56,945

 

 

 

21,957

 

 

 

34,988

 

 

 

 

 

Income tax provision

 

 

17,823

 

 

 

8,532

 

 

 

9,291

 

 

 

 

 

Net income

 

$

39,122

 

 

$

13,425

 

 

$

25,697

 

 

 

 

 

 

Total revenue

For the year ended December 31, 2017 total revenue increased by $14.6 million to $436.2 million, from $421.6 million for the year ended December 31, 2016. The increase was primarily driven by strong activity within the Oncology, Metabolic, and other uncategorized therapeutic areas.

Reimbursed out-of-pocket revenue decreased by $1.3 million to $49.7 million for the year ended December 31, 2017, from $51.0 million for the year ended December 31, 2016. Reimbursed out-of-pocket revenues can fluctuate significantly from period to period based on the timing of program initiation or closeout, and these changes do not necessarily correlate to changes in net service revenue. The reimbursements were offset by an equal amount of reimbursed out-of-pocket expenses.     

Total direct costs

Total direct costs increased by $12.0 million, to $261.5 million for the year ended December 31, 2017 from $249.5 million for the year ended December 31, 2016. The increase was primarily attributed to higher personnel costs of $9.3 million, service related supply costs of $2.8 million, office rents of $0.8 million and computer, software licenses and maintenance costs of $0.6 million in the year ended December 31, 2017, compared to the prior year, all to support the growth in project activities. This was partially offset by a decrease in Reimbursed out-of-pocket expenses, which can fluctuate significantly from period to period based on the timing of program initiation or closeout, of $1.3 million in the year ended December 31, 2017, compared to the prior year.

Selling, general and administrative

Selling, general and administrative expenses increased by $1.9 million, to $63.4 million for the year ended December 31, 2017 from $61.5 million for the year ended December 31, 2016. The increase was primarily driven by higher personnel costs of $2.5 million and professional service costs of $1.3 million in the year ended December 31, 2017, compared to the prior year, to support growth in project activities. This was offset by a reduction in bad debt expense of $2.1 million due primarily to net bad debt recoveries for the year ended December 31, 2017, compared to bad debt expense in the prior year. 

- 58 -


Depreciation and Amortization

Depreciation and amortization expense decreased by $11.6 million, to $46.5 million for the year ended December 31, 2017 from $58.1 for the year ended December 31, 2016. The decrease in depreciation and amortization was primarily related to the amortization of our definite lived intangible assets, which are amortized on an accelerated basis.

Loss on extinguishment of debt

During the year ended December 31, 2016, in connection with entering into the Senior Secured Credit Facilities (as defined below), the Company recorded a loss on extinguishment of long-term debt of $10.7 million in the fourth quarter of 2016, of which $10.2 million related to unamortized loan origination fees from the credit agreement for our 2014 Senior Secured Credit Facilities (as defined below) and $0.5 million related to third party fees incurred during the fourth quarter of 2016.  There was no extinguishment of long-term debt in the year ended December 31, 2017.

Miscellaneous expense, net

Miscellaneous expense, net decreased by $0.1 million to $0.4 million of expense for the year ended December 31, 2017 from $0.4 million of expense for the year ended December 31, 2016. These changes were mainly attributable to foreign exchange gains or losses that arise in connection with the revaluation of short-term inter-company balances between our domestic and international subsidiaries, gains or losses from foreign currency transactions, such as those resulting from the settlement of third-party accounts receivables and payables denominated in a currency other than the local currency of the entity making the payment and exit costs related to the previous headquarter lease.

Interest expense, net

Interest expense, net decreased by $11.8 million to $7.6 million for the year ended December 31, 2017 from $19.4 million for the year ended December 31, 2016. The decrease in interest expense, net for the year ended December 31, 2017 was related to the average lower outstanding balance under our Senior Secured Term Loan Facility (as defined below), as well as a lower effective interest rate as a result of the new credit agreement entered into in December 2016 (as described below).

Income tax provision

Income tax provision increased by $9.3 million, to $17.8 million for the year ended December 31, 2017 from $8.5 million for the year ended December 31, 2016. The overall effective tax rates for the years ended December 31, 2017 and 2016 were 31.3% and 38.9%, respectively. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as “Tax Cuts and Jobs Act” (TCJA). The effective tax rate for 2017 decreased from 2016 primarily due to the impact from the TCJA. Excluding the impacts of the new federal tax reform legislation, our effective income tax rate in 2017 would have been an expense of 36.2%. The remaining difference was primarily attributable to the impact of state taxes, domestic and foreign uncertain tax positions and the tax impact associated with acquired tax attributes.  

The 2017 TCJA significantly reforms the Internal Revenue Code of 1986, as amended. The TCJA, among other things, includes a reduction in the U.S. federal tax rate from 35% to 21%, allows for the expensing of capital expenditures and puts into effect the migration from a “worldwide” system of taxation to a territorial system.  The provisional impact on the year ended December 31, 2017 effective tax rate from the TCJA was primarily attributable to a one-time transition tax of $0.6 million on unrepatriated earnings of foreign subsidiaries as well as a tax benefit of $3.4 million related to the revaluation of the Deferred Credit which was partially offset by the revaluation of our deferred tax assets and liabilities and other miscellaneous tax attributes due to the reduction of the U.S. corporate tax rate from 35% to 21%.

- 59 -


Liquidity and Capital Resources

We assess our liquidity in terms of our ability to generate cash to fund our operating, investing and financing activities. Our principal sources of liquidity are operating cash flows and funds available for borrowing under our Senior Secured Revolving Credit Facility (as defined below). As of December 31, 2018, we had cash and cash equivalents of $23.3 million, including an immaterial amount of restricted cash, related to advanced payments received pursuant to certain sponsor contracts. Approximately $10.4 million of our cash and cash equivalents, none of which was restricted, was held by our foreign subsidiaries as of December 31, 2018.

On August 16, 2016, the Company completed its IPO of its common stock at a price of $23.00 per share.  We issued and sold 8,050,000 shares of common stock in the IPO. The IPO raised net proceeds of approximately $173.6 million after deducting underwriting discounts and commissions.  We used the proceeds from our IPO, combined with cash on hand, to repay $175.0 million of outstanding borrowings under our 2014 Senior Secured Term Loan Facility.

On December 8, 2016, the Company entered into a credit agreement (the “Senior Secured Credit Agreement”) consisting of a $165.0 million term loan (the “Senior Secured Term Loan Facility”) and a $150.0 million revolving credit facility (the “Senior Secured Revolving Credit Facility” and, together with the Senior Secured Term Loan Facility, the “Senior Secured Credit Facilities”). As of December 31, 2018, we had $149.8 million available for borrowing under our Senior Secured Revolving Credit Facility. Proceeds from the Senior Secured Term Loan Facility were used to repay and extinguish our obligations under the 2014 Senior Secured Credit Facilities as well as pay any fees, costs and expenses related thereto.

Our expected primary cash needs on both a short and long-term basis are for investment in operational growth, capital expenditures, payment of debt, share repurchases, selective strategic bolt-on acquisitions, other investments, and other general corporate needs. We have historically funded our operations and growth with cash flow from operations and borrowings under our credit facilities. We expect to continue expanding our operations through organic growth and potentially highly selective bolt-on acquisitions and investments. We expect these activities will be funded from existing cash, cash flow from operations and, if necessary, borrowings under our existing or future credit facilities or other debt.  We have deemed that foreign earnings will be indefinitely reinvested and therefore we have not provided taxes on these earnings.  While we do not anticipate the need to repatriate these foreign earnings for liquidity purposes given our cash flows from operations and available borrowings under existing and future credit facilities, we would incur taxes on these earnings if the need for repatriation due to liquidity purposes arises. We believe that our sources of liquidity and capital will be sufficient to finance our cash needs for the next 12 months and on a longer-term basis.  However, we cannot assure you that our business will generate sufficient cash flow from operations, or that future borrowings will be available to us under our Senior Secured Credit Facilities or otherwise, in an amount sufficient to fund our liquidity needs. If our cash flows and capital resources are insufficient to service our indebtedness, we may be forced to reduce or delay capital expenditures, sell assets, seek additional capital or restructure or refinance our indebtedness. See “Item 1A. Risk Factors—Risks Relating to our Indebtedness—We may not be able to generate sufficient cash to service all of our indebtedness, and may be forced to take other actions to satisfy our obligations under our indebtedness that may not be successful” in Part I of this Annual Report on Form 10-K.

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

Cash Flows (Amounts in thousands)

 

2018

 

 

2017

 

 

2016

 

Net cash provided by operating activities

 

$

156,584

 

 

$

97,385

 

 

$

91,732

 

Net cash used in investing activities

 

 

(16,973

)

 

 

(12,237

)

 

 

(13,422

)

Net cash used in financing activities

 

 

(141,580

)

 

 

(97,828

)

 

 

(58,008

)

Effect of exchange rates on cash, cash equivalents, and restricted cash

 

 

(1,241

)

 

 

1,765

 

 

 

(632

)

(Decrease) increase in cash, cash equivalents, and restricted cash

 

$

(3,210

)

 

$

(10,915

)

 

$

19,670

 

 

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Cash Flows from Operating Activities

Cash flows from operations are driven mainly by net income and net movement in accounts receivable and unbilled, net, advanced billings, pre-funded liabilities, accounts payable and accrued expenses. Accounts receivable and unbilled, net, advanced billings and pre-funded liabilities fluctuate on a regular basis as we perform our services, bill our customers and ultimately collect on those receivables. We attempt to negotiate payment terms in order to provide for payments prior to or soon after the provision of services, but this timing of collection can vary significantly on a period by period comparative basis.

Net cash flows provided by operating activities were $156.6 million for the year ended December 31, 2018 consisting of net income of $73.2 million. Adjustments to reconcile net income to net cash provided by operating activities were $43.8 million, primarily related to amortization of intangibles of $29.6 million, depreciation of $9.2 million, stock based compensation expense of $6.5 million, and deferred income tax provision of $3.9 million, offset by $7.7 million of amortization and adjustment of deferred credit. Changes in operating assets and liabilities provided $39.6 million in operating cash flows and were primarily driven by increased accrued expenses of $29.0 million and increased advanced billings of $35.6 million, offset by increased accounts receivable and unbilled, net of $27.0 million.

Net cash flows provided by operating activities were $97.4 million for the year ended December 31, 2017 consisting of net income of $39.1 million. Adjustments to reconcile net income to net cash provided by operating activities were $45.4 million, primarily related to amortization of intangibles of $37.9 million, depreciation of $8.6 million, stock based compensation expense of $4.5 million, and deferred income tax provision of $3.2 million, offset by $8.8 million of amortization and adjustment of deferred credit. Changes in operating assets and liabilities provided $12.9 million in operating cash flows and were primarily driven by increased accounts payable of $4.8 million, increased advanced billings of $7.7 million, and increased pre-funded study costs of $5.3 million, offset by increased prepaid expenses and other current assets of $3.5 million.

Net cash flows provided by operating activities was $91.7 million for the year ended December 31, 2016 consisting of net income of $13.4 million. Adjustments to reconcile net income to net cash provided by operating activities were $71.2 million, primarily related to amortization of intangibles of $50.7 million, depreciation of $7.4 million, loss on extinguishment of debt of $10.7 million, and stock based compensation expense of $9.8 million, offset by $9.0 million of benefit from deferred taxes. Changes in operating assets and liabilities provided $7.1 million in operating cash flows and were primarily driven by increased accrued expenses of $4.5 million primarily related to employee related costs, increased advanced billings of $14.7 million, offset by increased accounts receivable and unbilled services, net of $13.7 million, increased prepaid expenses and other current assets of $3.7 million, and a decrease in other assets and liabilities, net of $0.8 million.

Cash Flow from Investing Activities

Net cash used in investing activities was $17.0 million for the year ended December 31, 2018 primarily consisting of property and equipment expenditures.

Net cash used in investing activities was $12.2 million for the year ended December 31, 2017 primarily consisting of property and equipment expenditures.

Net cash used in investing activities was $13.4 million for the year ended December 31, 2016 primarily consisting of property and equipment expenditures.

Cash Flow from Financing Activities

Net cash used in financing activities was $141.6 million in the year ended December 31, 2018, primarily related to $72.2 million in principal payments on our Senior Secured Term Loan Facility and $70.0 million in principal payments on our Senior Secured Revolving Credit Facility.

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Net cash used in financing activities was $97.8 million in the year ended December 31, 2017, primarily related to $155.6 million in repurchases of common stock and $42.4 million in payments on our Senior Secured Credit Facilities, offset by $100.0 million in proceeds from the Senior Secured Revolving Credit Facility.

Net cash used in financing activities was $58.0 million for the year ended December 31, 2016 primarily related to $390.1 million in principal payments on our 2014 Senior Secured Term Loan Facility, offset by the IPO proceeds received of $173.6 million, and the proceeds from the issuance of debt, net of original issue discount of $164.5 million related to the Senior Secured Credit Facilities. The remaining activity consisted of rental payments on deemed landlord assets, payment of debt issuance costs, and the payment of common stock issuance costs.

Share Repurchases

In November 2017, the Board members who are not affiliated with Cinven (the “Disinterested Directors”) approved an agreement to repurchase 2,000,000 shares of the Company’s common stock from Cinven in connection with a Secondary Offering (as described in Note 1 of the Notes to the Consolidated Financial Statements) for aggregate consideration of approximately $60.3 million, representing a purchase price of $30.16 per share. The Company funded the repurchase with approximately $60.0 million in borrowings under the Senior Secured Revolving Credit Facility and cash on hand.

In August 2017, the Disinterested Directors of the Company approved a stock repurchase agreement with Medpace Limited Partnership, a Guernsey limited partnership (the “Limited Partnership” acting through its general partner, Medpace GP Limited, a Guernsey company, the “General Partner” and, the Limited Partnership acting through the General Partner, “Cinven”), pursuant to which the Company repurchased 2,000,000 shares of the Company’s common stock from Cinven for aggregate consideration of approximately $60.5 million, representing a purchase price of $30.27 per share. The Company funded the repurchase with cash on hand and $40.0 million in borrowings under our Senior Secured Revolving Credit Facility.

In April 2017, the Board of the Company authorized a share repurchase program with an authorized repurchase level of $50.0 million. The share repurchase program was cancelled in the fourth quarter of 2017. Repurchases under the repurchase program took place in the open market or negotiated transactions, at the discretion of the Company’s management. During the year ended December 31, 2017, the Company repurchased 1,342,786 shares of its outstanding common stock for $34.7 million under this share repurchase program.

The Company has elected to constructively retire all repurchased shares with all amounts paid in excess of Common stock par value reflected within Accumulated deficit in the Company’s consolidated balance sheets, except for 200,000 shares, which are reflected within treasury stock in the Company’s consolidated balance sheets.

Indebtedness

On December 8, 2016 (the “Closing Date”), Medpace IntermediateCo, Inc., as borrower (the “Borrower”), and Medpace Acquisition, Inc., a wholly-owned subsidiary of the Company, as parent guarantor (the “Parent Guarantor”), entered into the Senior Secured Credit Agreement, which provides for the Senior Secured Term Loan Facility of $165.0 million and the Senior Secured Revolving Credit Facility of $150.0 million. The Senior Secured Term Loan Facility and Senior Secured Revolving Credit Facility expire in December 2021. Borrowings under the Senior Secured Credit Facilities were utilized to repay and extinguish our obligations under our existing senior secured term loan facility (the “2014 Senior Secured Term Loan Facility”) and our existing senior secured revolving credit facility (the “2014 Senior Secured Revolving Credit Facility” and, together with the 2014 Senior Secured Term Loan Facility, the “2014 Senior Secured Credit Facilities”), as well as pay any related fees, costs and expenses.

The Senior Secured Credit Facilities are guaranteed by the Parent Guarantor and its material, direct or indirect wholly owned domestic subsidiaries, with certain exceptions, including where providing such guarantees is not permitted by law, regulation or contract or would result in adverse tax consequences. All of the obligations under the Senior Secured Credit Facilities are secured, subject to certain permitted liens and other exceptions, by substantially all of the assets of the Borrower and each guarantor, including, but not limited to, a perfected pledge of all of the capital stock of the Borrower and of each guarantor (other than the Parent Guarantor) and, subject to certain exceptions, perfected security interests in substantially all other tangible and intangible assets of the Borrower and each guarantor.

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As of December 31, 2018, there was $80.4 million outstanding under the Senior Secured Term Loan Facility and no borrowings outstanding under the Senior Secured Revolving Credit Facility. In connection with entering into the Senior Secured Credit Facilities, the Company recorded a loss on extinguishment of long-term debt of $10.7 million during the fourth quarter of 2016, of which $10.2 million related to unamortized loan origination fees from the credit agreement for our 2014 Senior Secured Credit Facilities and $0.5 million related to third party fees incurred during the fourth quarter of 2016.

Borrowings under the Senior Secured Credit Facilities bear interest at a rate equal to, at our option, either (i) the adjusted Eurocurrency rate based on LIBOR for U.S. dollar deposits for loans denominated in dollars, EURIBOR for Euro deposits for loans denominated in Euros and the offer rate for any other currencies for loans denominated in such other currencies for the relevant interest period plus an applicable margin from 1.25% to 2.25% based on the total net leverage ratio from less than 1.50:1.00 to greater than 3.75:1:00, or (ii) an alternative base rate (determined by reference to the highest of (a) the prime commercial lending rate of the administrative agent, as established from time to time, (b) the Federal Funds Rate plus 0.50% and (c) the one-month adjusted Eurocurrency rate for loans in U.S. dollars plus 1.00%) plus an applicable margin from 0.25% to 1.25% based on the total net leverage ratio from less than 1.50:1.00 to greater than 3.75:1:00.  The applicable margin as of December 31, 2018 was 1.25% for Eurocurrency loans and 0.25% for base rate loans. At our discretion, we may choose interest periods of one, two, three or six months, which determines the interest rate to be applied. Interest on the Eurocurrency rate loan continues to be payable at the end of the selected Eurocurrency term and interest on the base rate tranche of the Senior Secured Term Loan Facility is payable quarterly in conjunction with any required principal payments.

We also pay commitment fees on a quarterly basis at an annual rate of 0.375% of the unused borrowings under the Senior Secured Revolving Credit Facility for the first full fiscal quarter after the Closing Date, and thereafter at 0.50% if the total net leverage ratio is greater than or equal to 3.00:1.00, or 0.375% if the total net leverage ratio is less than 3.00:1.00.  

The Senior Secured Term Loan Facility will amortize in quarterly installments in aggregate annual amounts equal to (i) 7.5% of the original principal amount of the Senior Secured Term Loan Facility during the first year after the Closing Date, (ii) 10.0% of the original principal amount of the Senior Secured Term Loan Facility during the second year after the Closing Date, (iii) 10.0% of the original principal amount of the Senior Secured Term Loan Facility during the third year after the Closing Date, (iv) 12.5% of the original principal amount of the Senior Secured Term Loan Facility during the fourth year after the Closing Date and (v) 15.0% of the original principal amount of the Senior Secured Term Loan Facility during the fifth year after the Closing Date. The first amortization payment was due on March 31, 2017 and the remaining balance of the original principal amount of the Senior Secured Term Loan Facility outstanding at maturity will be paid in a final balloon payment. The Senior Secured Revolving Credit Facility terminates on the fifth anniversary of the Closing Date and loans thereunder may be borrowed, repaid, and re-borrowed up to such date.

The following amounts are required to be prepaid in addition to quarterly installment payments and will be applied to repay the Senior Secured Term Loan Facility, subject to certain thresholds, carve-outs, exceptions and reinvestment rights: (a) to the extent that the net cash proceeds of non-ordinary course asset sales or other dispositions of property in a transaction or related transactions by the Borrower and its subsidiaries (including, without limitation, insurance and condemnation proceeds) exceeds $10 million in any fiscal year, 100% of such excess net cash proceeds; (b) 100% of the net cash proceeds of certain debt incurred by the Borrower and its restricted subsidiaries after the Closing Date; and (c) to the extent that net cash proceeds received by the Borrower and its restricted subsidiaries in connection with the disposition of any accounts receivable or related assets to a permitted receivables financing subsidiary exceeds $5 million at any time, 100% of such excess net cash proceeds. In addition to the mandatory payments above, the Borrower may voluntarily repay the outstanding Senior Secured Term Loan Facility without premium or penalty, subject to certain restrictions.

The Senior Secured Credit Facilities are subject to customary negative covenants that, among other things, limit the Borrower and its restricted subsidiaries to, subject to certain exceptions and carve outs:

 

create, incur or assume any lien upon any of the property, assets or revenue;

 

make or hold certain investments;

- 63 -


 

incur or assume any indebtedness;

 

merge, dissolve, liquidate or consolidate with or into another person;

 

make certain dispositions of property or other assets (including sale leaseback transactions);

 

declare or make certain restricted payments, including dividends;

 

enter into certain transactions with affiliates;

 

prepay subordinated debt;

 

enter into burdensome agreements;

 

engage in any material line of business substantially different from currently conducted business; or

 

change fiscal year.

In addition, the Borrower is required to report compliance with two financial covenants that are tested at the end of each fiscal quarter. The Borrower is required to maintain a ratio of consolidated funded indebtedness minus unrestricted cash and cash equivalents (in the aggregate not to exceed $50 million and to include not more than $25 million of foreign unrestricted cash and cash equivalents) to consolidated EBITDA for the most recent four fiscal quarter period not to exceed 4.00:1.00; provided that the Borrower shall be permitted to increase the ratio to 4.50:1.00 in connection with any permitted acquisition or any other acquisition consented to by Administrative Agent and the Required Lenders (as defined in the Senior Secured Credit Agreement) with total cash consideration in excess of $25 million.  Such increase shall be applicable for the fiscal quarter in which such acquisition is consummated and the three consecutive test periods thereafter.  The Borrower is also required to maintain a ratio of consolidated EBITDA to consolidated interest expense, in each case for the most recent four fiscal quarter period, of not less than 3.00:1.00. The Company was in compliance with all financial covenants as of December 31, 2018.

The Senior Secured Credit Facilities contain certain events of default, including, among others, non-payment of principal or interest, breach of the covenants, cross default and cross acceleration to certain other indebtedness, defaults on monetary judgment orders, certain ERISA events, certain bankruptcy and insolvency events, actual or asserted invalidity of any guarantee or security document and change in control.

As of December 31, 2018, we had total indebtedness of $80.4 million, all of which was attributed to outstanding borrowings on the Senior Secured Term Loan Facility. There were no outstanding borrowings under the Senior Secured Revolving Credit Facility as of December 31, 2018. In addition, as of December 31, 2018, we had $0.2 million in letters of credit outstanding related to certain operating lease obligations, which are secured by the Senior Secured Revolving Credit Facility.

Contractual Obligations and Commercial Commitments

We have various contractual obligations, which are recorded as liabilities in our consolidated financial statements. Other items, such as operating lease obligations, are not recognized as liabilities in our consolidated financial statements but are required to be disclosed. The following table summarizes our future payments for all contractual obligations and commercial commitments for the years subsequent to the year ended December 31, 2018:

 

 

 

Payments Due by Period

 

Contractual Obligations (In thousands)

 

Total

 

 

Less than 1 year

 

 

1-3 years

 

 

3-5 years

 

 

More than 5 years

 

Long-term debt obligations

 

$

80,438

 

 

$

-

 

 

$

80,438

 

 

$

-

 

 

$

-

 

Interest on long-term debt

 

 

10,716

 

 

 

3,649

 

 

 

7,067

 

 

 

-

 

 

 

-

 

Operating lease obligations

 

 

163,029

 

 

 

8,173

 

 

 

26,297

 

 

 

18,937

 

 

 

109,622

 

Deemed landlord liabilities

 

 

35,879

 

 

 

3,918

 

 

 

8,027

 

 

 

8,237

 

 

 

15,697

 

Total

 

$

290,062

 

 

$

15,740

 

 

$

121,829

 

 

$

27,174

 

 

$

125,319

 

 

The interest payments on long-term debt in the above table are based on interest rates in effect as of December 31, 2018.  

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We have recorded a tax liability for unrecognized benefits for uncertain tax positions of $7.2 million, which has not been included in the above table due to the uncertainties in the timing of settlement of the income tax positions.

We are a party to certain vendor contracts related to clinical services that if cancelled may require payments for services performed and potentially additional services required to protect safety of subjects.  The value of these potential wind-down provisions is generally borne by our customers and is not practical to estimate.

Off-Balance Sheet Arrangements

Off-balance sheet arrangements refer to any transaction, agreement or other contractual arrangement to which an entity not consolidated under our entity structure exists, where we have an obligation arising under a guarantee contract, derivative instrument or variable interest or a retained or contingent interest in assets transferred to such an entity or similar arrangement that serves as credit, liquidity or market risk support for such assets. We have no off-balance sheet arrangements.

Critical Accounting Policies and Estimates

The preparation of financial statements in accordance with generally accepted accounting principles in the United States of America, or US GAAP, requires us to make a variety of decisions which affect reported amounts and related disclosures, including the selection of appropriate accounting principles and the assumptions on which to base accounting estimates. In reaching such decisions, we apply judgment based on our understanding and analysis of the relevant circumstances, including our historical experience and other assumptions. Actual results could differ from our estimates. We are committed to incorporating accounting principles, assumptions and estimates that promote the representational faithfulness, verifiability, neutrality and transparency of the accounting information included in the financial statements.

Revenue Recognition

We generally enter into contracts with customers to provide services ranging in duration from a few months to several years. The contract terms generally provide for payments based on a fixed-fee or unit-of-service arrangement. We account for revenue in accordance with ASC 606, Revenue from Contracts with Customers, which we adopted on January 1, 2018.  Revenue on contracts is recognized,  when or as we satisfy the contract performance obligations by transferring control of the services provided to the customer, at the amount that reflects the consideration to which we expect to be entitled in exchange for transferring those services.  Our performance obligations are generally satisfied over time and recognized as work progresses.

Contract Assumptions

Accounting for contracts performed over a period of time involves the use of various assumptions to estimate total contract revenue and costs.  We estimate expected costs to complete a contract and recognize contracted revenue over the life of the contract as those costs are incurred while performing our contracted obligations.

Cost estimates are based on a detailed project budget and are developed based on many variables, including, but not limited to, the scope of the work, labor productivity, the complexity of the study, the participating geographic locations and the Company’s historical experience.  To assist with the estimation of costs expected at completion over the life of a project, regular contract reviews are performed in which performance to date is compared to the most current estimate to complete assumptions. The reviews include an assessment of costs incurred to date compared to expectations based on budget assumptions and other circumstances specific to the project. The total estimated costs necessary to complete is updated and any revisions to the existing cost estimate results in cumulative adjustments to the amount of revenue recognized in the period in which the revisions are identified. Because of the uncertainties inherent in estimating the costs necessary to fulfill contractual obligations, it is possible that estimates may change in the near term, resulting in a material change in revenue reported.

Contracts generally provide for pricing modifications upon scope of work changes. We recognize revenue, at an amount to which we expect to be entitled, related to work performed in connection with scope changes when the

- 65 -


underlying services are performed and a binding contractual commitment has been established with the customer.  If our customers do not agree to pricing changes upon changes in our scope of work, we could be exposed to cost overruns and reduced contract profitability. Costs are not deferred in anticipation of contracts being awarded or amendments being finalized, but are expensed as incurred.

Most contracts are terminable by the customer, either immediately or according to advance notice terms specified within the contracts. These contracts require payment of fees for services rendered through the date of termination and may require payment for subsequent services necessary to conclude the study or close out the contract. Final settlement amounts are agreed to with the customer based on remaining work to be performed. These amounts are included in revenue when we believe the amount can be estimated reliably and its realization is probable.  In evaluating the probability of recognition, we consider the contractual basis for the settlement amount and the objective evidence available to support the amount.

Certain contracts contain volume rebate arrangements with our customers that provide for rebates if certain specified spending thresholds are met.  These obligations are considered as a reduction in revenue when it appears probable that the arrangement thresholds will be met.

We occasionally enter into incentive fee arrangements with customers that provide for additional compensation if certain defined contractual milestones or performance thresholds are met. These additional fees are included in the estimated transaction price when there is a basis to reasonably estimate the amount of the fee and when achievement of the incentive milestone is deemed probable.  These estimates are based on anticipated performance, our best judgment at the time or ultimately, upon achievement of the threshold or milestone.

We record revenue net of any tax assessments by governmental authorities that are imposed and concurrent with specific revenue generating transactions.

Performance Obligations

Substantially all of our contracts consist of a single performance obligation, as the promise to transfer the individual services described in the contracts are not separately identifiable from other promises in the contracts, and therefore not distinct.  Revenue recognition is determined by assessing the progress of performance completed or delivered to date compared to total services to be delivered under the terms of the arrangement. The measures utilized to assess progress on the satisfaction of performance are specific to the performance obligation identified in the contract.  

For the majority of our contract performance obligations, we utilize the input method of cost to cost to measure progress.  Under this method, the Company determines cost incurred to date for the services it provides compared to the total estimated costs at completion.  

For certain other contractual performance obligations, the Company has determined that an output method is the best measure of progress.  These relate to certain unitized contracts, and the Company recognizes revenue in the period in which the unit is delivered compared to total contracted units.

Goodwill and Indefinite Lived Intangible Assets

Goodwill

Goodwill represents the excess of purchase price over the fair value of net assets acquired in business combinations. Our reporting units are Phase II-IV clinical research services, or Phase II-IV, Laboratories and Clinics.

The carrying value of goodwill is reviewed at least annually for impairment, or as indicators of potential impairment are identified, at the reporting unit level. We perform our annual goodwill impairment test during the fourth quarter each year, utilizing the quantitative two step model defined by accounting guidance which governs such assessments. The first step involves the comparison of each of our reporting unit carrying values, inclusive of assigned goodwill, to their respective estimated fair values. If a reporting unit carrying value exceeds estimated fair value, a second step requiring us to calculate the implied reporting unit goodwill fair value is performed. The implied fair value of goodwill is determined by performing a hypothetical purchase price allocation of reporting unit

- 66 -


fair value to the reporting units identified assets and liabilities. The resulting implied goodwill fair value is compared to carrying value to determine the extent of impairment, if any exists. Reporting unit fair value is estimated using a combination of the income approach, a discounted cash flow analysis, and the market approach, utilizing the guideline company method. The reporting unit’s discounted cash flow analysis requires significant management judgment with respect to net revenue, total direct costs and amortization, selling, general and administrative expenses, capital expenditures and the selection and use of an appropriate discount rate. The projected revenue and expense assumptions and capital expenditures are based on our annual and long-term business plans. Discount rates reflect market-based estimates of the risks associated with the projected cash flows directly resulting from the use of those assets in operations.

There was no indication of impairment related to goodwill based on the fourth quarter 2018 assessment as the fair value of the reporting units was substantially in excess of carrying value.

This process is inherently subjective and dependent upon estimates and assumptions we make. In determining our expected future cash flows, we assume that we will continue to acquire and convert new business to contract, execute on these contracts with reasonable profit, collect customer receivables and thus generate positive cash flows. However, future declines in the operating results of these reporting units could indicate a need to reevaluate the fair value of these components under accounting guidance governing goodwill and may ultimately result in future impairment. We continue to monitor for any potential indicators of impairment.

Intangible Assets

The Company has an indefinite lived intangible asset related to its trade name valued at $31.6 million. The carrying value of the trade name asset is reviewed at least annually for impairment, or as indicators of potential impairment are identified. The Company performs its annual impairment test in the fourth quarter each year in conjunction with its annual assessment of goodwill. The assessment consists of comparing the carrying value of the indefinite lived intangible asset to its estimated fair value, utilizing the relief from royalty method, an income approach valuation. The relief from royalty method requires management judgment with respect to projected net revenue, profitability and growth and the selection and use of an appropriate discount rate. There was no indication of impairment related to the trade name asset based on the fourth quarter 2018 assessment.

Our assessment of impairment charges on any assets classified currently as having indefinite lives could change in future periods if certain events were to occur, including, but not limited to, the following: a significant change in business results, an increase in our discount rates due to a change in our weighted average cost of capital, a decrease in growth rates, economic deterioration that is more severe or longer in duration than anticipated or another significant economic event.

Finite-lived intangible assets consist mainly of the value assigned to customer relationships, backlog and developed technologies. Finite-lived intangible assets are amortized straight-line or using an accelerated method over their estimated useful lives, which range in term from 5 to 15 years. Amortization expense recognized related to finite lived intangible assets was $29.6 million, $37.9 million and $50.7 million, respectively, for the years ended December 31, 2018, 2017 and 2016.

Income Taxes

We are subject to income taxes in the United States and numerous foreign jurisdictions. Significant judgment is required in the forecasting of taxable income using historical and projected future operating results in determining our provision for income taxes and the related assets and liabilities. The provision for income taxes includes income taxes paid, currently payable and receivable, and deferred taxes.

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We record deferred tax assets and liabilities based on temporary differences between the financial statement bases and tax bases of assets and liabilities. Deferred tax assets are recorded for tax benefit carryforwards using tax rates anticipated to be in effect in the year in which temporary differences are expected to reverse. If it does not appear more likely than not that the full value of a deferred tax asset will be realized, the Company records a valuation allowance against the deferred tax asset, with an offsetting charge to the Company’s income tax provision or benefit.

The recoverability of our deferred tax assets is estimated based on consideration of all available positive and negative evidence, including, but not limited to, our ability to generate a sufficient level of future taxable income, reversals of deferred tax liabilities (other than those with an indefinite reversal period), tax planning strategies and recent financial performance. The assessment of recoverability is performed on a jurisdiction by jurisdiction basis. Based on the analysis of the above factors, we determined that as of December 31, 2018 and 2017 a valuation allowance in the amount of $0.2 million and $2.4 million, respectively, was required relating to certain foreign operating loss carryforwards, U.S. operating loss carryforwards, a U.S. capital loss carryforward and U.S. state and local operating loss carryforwards. Differences in actual results compared to our estimates and changes in our assumptions could result in an adjustment to the valuation allowance in the future and would generally impact earnings or other comprehensive income depending on the nature of the respective deferred asset for which the valuation allowance exists.

We have recognized certain liabilities, including penalties and interest in the amount of $1.0 million as of December 31, 2018, within other long-term liabilities on the consolidated balance sheets. These relate to uncertain tax positions that are subject to various assumptions and judgment. Liabilities for these uncertain tax positions are assessed on a position by position basis. The calculation of these liabilities involves dealing with uncertainties in the application of complex tax regulations in both domestic and foreign jurisdictions. These positions may be subject to audit and review by tax authorities, and may result in future taxes, interest and penalties if we are unsuccessful in defending our positions. If the calculation of liability related to uncertain tax positions proves to be more or less than the ultimate assessment, a tax expense or benefit to expense, respectively would result.

As of December 31, 2018 and 2017, as a result of an updated analysis of future cash needs in the United States and opportunities for investment outside the United States, we assert that all foreign earnings will be indefinitely reinvested and therefore we have not provided taxes on these earnings. These undistributed earnings of foreign subsidiaries will support future growth in foreign markets and maintain current operating needs of foreign locations. We will continue to monitor our assertion related to investment of foreign earnings. See Note 12 of the Notes to Consolidated Financial Statements for further information regarding this assertion.

Stock Based Compensation

We have stock based compensation plans in which we issue stock based awards to employees and directors in the form of vested common shares, stock options, stock appreciation rights (SARs), restricted stock awards (RSAs), restricted stock units (RSUs), or other cash based or stock dividend equivalent awards.  All of our currently outstanding awards are subject to equity classification pursuant to the terms of the award grants and based on accounting guidance which governs such transactions. Accounting guidance applicable to equity classified awards require all stock based compensation, including vested shares, grants of employee stock options and restricted stock to be recognized in the consolidated statements of operations based on their grant date fair values.

We estimate the fair value of our stock options utilizing the Black-Scholes-Merton option pricing model, which requires the input of highly subjective assumptions including: the expected stock price volatility, the calculation of the expected holding period of the award, the risk free interest rate and expected dividends on the underlying common stock. Due to the lack of Company specific historical and implied volatility data, we have based our estimate of expected volatility on the historical volatility of a group of peer companies that are most representative of our company. The historical volatility is calculated based on a period of time commensurate with the expected holding period assumption. The holding period represents the period that our option awards are expected to be outstanding. We use the simplified method as prescribed by accounting guidance governing such awards, to calculate the expected term for options granted to employees as we do not have sufficient historical evidence data to provide a reasonable basis upon which to estimate the expected holding period. This simplified method utilizes the mid-point between the vesting date and the date of the contractual term. The risk free rate is based on extrapolated rates of U.S. Treasury bonds whose terms are consistent with the expected holding period of the stock options. We have assumed a dividend yield of zero as we have not historically paid any dividends on our common stock.

- 68 -


All our stock based option awards are subject to service based vesting conditions. Compensation expense related to stock option awards to employees is recognized on a straight line basis based on the grant date fair value over the associated service period of the award, which is equal to the vesting term.

The following table summarizes the key weighted average assumptions used in the Black-Scholes-Merton option pricing model to calculate the fair value of options during the periods:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Expected holding period - years

 

5.4

 

 

5.4

 

 

3.6

 

Expected volatility

 

27.0%

 

 

28.0%

 

 

30.2%

 

Risk-free interest rate

 

2.8%

 

 

2.0%

 

 

1.0%

 

Expected dividend yield

 

 

0.0%

 

 

 

0.0%

 

 

 

0.0%

 

 

The assumptions used in the table above reflect both grant date inputs to arrive at the grant date fair values for stock options subject to equity-classified stock compensation accounting and reflect a fair value calculation for stock options outstanding in the period subject to liability-classified stock compensation accounting.  As of December 31, 2018 all outstanding stock based awards were subject to equity classification through either modifications of the award terms and conditions that occurred during the year ended December 31, 2016, or based on terms and conditions applicable as of the grant date.

The weighted average grant date fair value of employee stock options granted was $11.51, $8.54 and $6.91 for the years ended December 31, 2018, 2017 and 2016.

Effect of Recent Accounting Pronouncements

Refer to Note 3 of the Notes to Consolidated Financial Statements for management’s discussion of the effect of recent accounting pronouncements.

 

 

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

Market risk is the potential loss arising from adverse changes in market rates and prices, such as foreign currency exchange rates, inflation, interest rates, and other relevant market rates or prices changes. We are exposed to market risk from changes in foreign currency exchange rates, interest rates, inflation rate and credit risk and we regularly evaluate our exposure to such changes.  

Foreign Currency Risk

We have business operations globally, and accordingly, we are exposed to foreign currency fluctuations that can affect our financial results. For the years ended December 31, 2018 and 2017, approximately 8.7% and 7.6% of our revenue was derived from contracts denominated in currencies other than the U.S. dollar, whereas approximately 29.8% and 28.6% of our operational costs, including, but not limited to, salaries, wages and other employee benefits, were derived in foreign currencies. Of these exposures, approximately 87.5% and 89.0% of revenue denominated in foreign currencies and approximately 48.3% and 49.6% of operational costs denominated in foreign currencies were Euro denominated for the years ended December 31, 2018 and 2017, respectively.  Our financial statements are reported in U.S. dollars and, accordingly, fluctuations in exchange rates will affect the translation of our revenues and expenses denominated in foreign currencies into U.S. dollars for purposes of reporting our consolidated financial results. We recalculated our reported pre-tax income for the years ended December 31, 2018 and 2017 using foreign exchange rates that were 10% higher and 10% lower than actual exchange rates utilized during the year. When utilizing foreign exchange rates 10% higher than actual exchange rates, our pre-tax income for the years ended December 31, 2018 and 2017 is positively impacted by approximately $5.1 million and $5.2 million, respectively. When utilizing foreign exchange rates 10% lower than actual exchange rates, our pre-tax income for

- 69 -


the years ended December 31, 2018 and 2017 is negatively impacted by approximately $5.1 million and $5.2 million, respectively.

We are also subject to foreign currency transaction risk for fluctuations in exchange rates during the period of time between contract commencement and cash settlement for services that we provide in relation to the contract. This exposure may affect our contract and operational profitability. To mitigate our foreign currency risk exposure we provide for exchange rate fluctuation adjustments subject to certain thresholds within our contracts where contract currency varies from currencies where costs will be incurred to support delivery of the contract.

Interest Rates

We are primarily exposed to interest rate risk through our Senior Secured Credit Facilities. As of the year ended December 31, 2018, we had outstanding amounts related to the Senior Secured Credit Facilities of $79.7 million (net of an unamortized discount of $0.3 million and unamortized debt issuance costs of $0.4 million). As of the year ended December 31, 2017, we had outstanding amounts related to the Senior Secured Credit Facilities of $221.6 million (net of an unamortized discount of $0.4 million and unamortized debt issuance costs of $0.6 million). The Senior Secured Credit Facilities are subject to variable interest rates. Each quarter-point increase or decrease in the applicable interest rate as of the year ended December 31, 2018 and 2017 would change our interest expense by approximately $0.2 million and $0.4 million, respectively. The Senior Secured Credit Facilities are not subject to any interest rate caps or floors.

Credit Risk

Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents, and accounts receivable and unbilled, net. The cash and cash equivalent balances are held and maintained with high-quality financial institutions with reputable credit ratings and, consequently, we believe that such funds are subject to minimal credit risk.

We generally do not require collateral or other securities to support customer receivables. In the years ended December 31, 2018 and 2017, credit losses have been immaterial and within our expectations. Moreover, in many cases we require advance payment from our customers for a portion of the study contract price upon the signing of a service contract which helps to mitigate credit risk. As of the years ended December 31, 2018 and 2017, there were no major customers accounting for more than 10% of our accounts receivable and unbilled, net.

Inflation

Our contracts that provide for services to be performed in excess of a year generally are based on inflation assumptions for the portion of the services to be performed beyond one year. We do not have significant operations in countries where the economy is considered highly inflationary, and do not believe in the near term that inflation will have a material adverse impact on us. However, if actual rates are greater than our inflation assumptions, inflation could have a material adverse effect on our operations or financial condition.

Item 8. Financial Statements and Supplementary Data.

Management's Report on Internal Control Over Financial Reporting

Management of Medpace Holdings, Inc. (the “Company”) is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our consolidated financial statements for external reporting purposes in accordance with accounting principles generally accepted in the United States of America. Internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company, (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, and that receipts and expenditures are being made only in accordance with authorizations of our management and directors, and (3) provide reasonable assurance regarding prevention or timely detection of

- 70 -


unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the consolidated financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements in the consolidated financial statements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2018. In making these assessments, management used the framework established by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control — Integrated Framework (2013). Based on management’s assessment and the criteria in the COSO framework, management has concluded that the Company’s internal control over financial reporting as of December 31, 2018 was not effective as of December 31, 2018 due to a material weakness related to the implementation of ASU No. 2014-09 “Revenue from Contracts with Customers (Topic 606). Specifically, we did not maintain effective controls over the implementation of the new accounting standard including proper application of the Company’s new revenue recognition policies. A “material weakness” is a deficiency, or a combination of deficiencies, in Internal Control over Financial Reporting ("ICFR"), such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

As an emerging growth company, our independent registered public accounting firm is not required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 until the later of the year following our first annual report required to be filed with the SEC or the date we are no longer an emerging growth company

Plan to Remediate Material Weakness

Management is developing and implementing a plan to remediate the material weakness discussed above and will continue to evaluate and take actions to improve our internal control over financial reporting.

- 71 -


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 

To the Shareholders and Board of Directors of

Medpace Holdings, Inc. and subsidiaries

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Medpace Holdings, Inc. and its subsidiaries (the “Company”) as of December 31, 2018 and 2017, the related consolidated statements of operations, comprehensive income, shareholders' equity, and cash flows, for each of the three years in the period ended December 31, 2018, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2018 and 2017, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2018, in conformity with accounting principles generally accepted in the United States of America.

Change in Accounting Principle

As discussed in Note 3 to the financial statements, the Company has changed its method of accounting for revenue recognition as of January 1, 2018, due to the adoption of Financial Accounting Standards Board Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, using a modified retrospective approach.

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Deloitte & Touche LLP

 

Cincinnati, Ohio

February 26, 2019

We have served as the Company’s auditor since 2002.

 

- 72 -


MEDPACE HOLDINGS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

 

 

 

 

 

 

 

 

 

(Amounts in thousands, except share amounts)

 

 

 

 

 

As Of December 31,

 

 

 

2018

 

 

2017

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

23,275

 

 

$

26,485

 

Restricted cash

 

 

7

 

 

 

7

 

Accounts receivable and unbilled, net (includes $3.8 million and $1.0 million with related parties at December 31, 2018 and 2017, respectively)

 

 

133,449

 

 

 

83,079

 

Prepaid expenses and other current assets

 

 

21,383

 

 

 

20,400

 

Total current assets

 

 

178,114

 

 

 

129,971

 

Property and equipment, net

 

 

52,255

 

 

 

48,739

 

Goodwill

 

 

660,981

 

 

 

660,981

 

Intangible assets, net

 

 

69,179

 

 

 

98,740

 

Deferred income taxes

 

 

713

 

 

 

6,343

 

Other assets

 

 

6,691

 

 

 

5,943

 

Total assets

 

$

967,933

 

 

$

950,717

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable (includes $0.3 million and $0.2 million with related parties at December 31, 2018 and 2017, respectively)

 

$

16,737

 

 

$

16,674

 

Accrued expenses

 

 

87,493

 

 

 

23,673

 

Pre-funded study costs (includes $1.0 million with related parties at December 31, 2017)

 

 

-

 

 

 

57,406

 

Advanced billings (includes $0.4 million and $1.7 million with related parties at December 31, 2018 and 2017, respectively)

 

 

147,935

 

 

 

73,756

 

Current portion of long-term debt

 

 

-

 

 

 

16,500

 

Other current liabilities

 

 

4,861

 

 

 

4,697

 

Total current liabilities

 

 

257,026

 

 

 

192,706

 

Long-term debt, net, less current portion

 

 

79,721

 

 

 

205,111

 

Deemed landlord liability, less current portion

 

 

24,484

 

 

 

26,602

 

Deferred income tax liability

 

 

439

 

 

 

560

 

Deferred credit

 

 

3,756

 

 

 

11,468

 

Other long-term liabilities

 

 

12,804

 

 

 

10,740

 

Total liabilities

 

 

378,230

 

 

 

447,187

 

Commitments and contingencies (see Note 9)

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock - $0.01 par-value; 5,000,000 shares authorized; no shares issued and outstanding at December 31, 2018 and 2017, respectively

 

 

-

 

 

 

-

 

Common stock - $0.01 par-value; 250,000,000 shares authorized at December 31, 2018 and 2017, respectively; 35,665,910 and 35,466,510 shares issued and outstanding at December 31, 2018 and 2017, respectively

 

 

356

 

 

 

355

 

Treasury stock - 200,000 shares at December 31, 2018 and 2017, respectively

 

 

(6,030

)

 

 

(6,030

)

Additional paid-in capital

 

 

639,381

 

 

 

630,341

 

Accumulated deficit

 

 

(41,487

)

 

 

(120,402

)

Accumulated other comprehensive loss

 

 

(2,517

)

 

 

(734

)

      Total shareholders’ equity

 

 

589,703

 

 

 

503,530

 

      Total liabilities and shareholders’ equity

 

$

967,933

 

 

$

950,717

 

 

See notes to consolidated financial statements.

- 73 -


MEDPACE HOLDINGS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

 

 

 

 

 

 

(Amounts in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Revenue, net (includes $15.1 million with related parties for the year ended December 31, 2018)

 

$

704,589

 

 

$

-

 

 

$

-

 

Service revenue, net (includes $11.1 million and $24.1 million with related parties for the years ended December 31, 2017 and 2016, respectively)

 

 

-

 

 

 

386,462

 

 

 

370,621

 

Reimbursed out-of-pocket revenue (includes $1.5 million and $5.4 million with related parties for years ended December 31, 2017 and 2016, respectively)

 

 

-

 

 

 

49,690

 

 

 

50,961

 

Total revenue

 

 

704,589

 

 

 

436,152

 

 

 

421,582

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Direct service costs, excluding depreciation and amortization

 

 

252,284

 

 

 

211,773

 

 

 

198,510

 

Reimbursed out-of-pocket expenses

 

 

236,775

 

 

 

49,690

 

 

 

50,961

 

Total direct costs

 

 

489,059

 

 

 

261,463

 

 

 

249,471

 

Selling, general and administrative

 

 

75,681

 

 

 

63,357

 

 

 

61,507

 

Depreciation

 

 

9,240

 

 

 

8,574

 

 

 

7,442

 

Amortization

 

 

29,561

 

 

 

37,900

 

 

 

50,672

 

Total operating expenses

 

 

603,541

 

 

 

371,294

 

 

 

369,092

 

Income from operations

 

 

101,048

 

 

 

64,858

 

 

 

52,490

 

Other expense, net:

 

 

 

 

 

 

 

 

 

 

 

 

Loss on extinguishment of debt

 

 

-

 

 

 

-

 

 

 

(10,726

)

Miscellaneous income (expense), net

 

 

1,060

 

 

 

(354

)

 

 

(423

)

Interest expense, net

 

 

(8,157

)

 

 

(7,559

)

 

 

(19,384

)

Total other expense, net

 

 

(7,097

)

 

 

(7,913

)

 

 

(30,533

)

Income before income taxes

 

 

93,951

 

 

 

56,945

 

 

 

21,957

 

Income tax provision

 

 

20,766

 

 

 

17,823

 

 

 

8,532

 

Net income

 

$

73,185

 

 

$

39,122

 

 

$

13,425

 

Net income per share attributable to common

   shareholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

2.05

 

 

$

1.00

 

 

$

0.38

 

Diluted

 

$

1.97

 

 

$

0.98

 

 

$

0.37

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

35,547

 

 

 

39,056

 

 

 

35,690

 

Diluted

 

 

36,912

 

 

 

39,839

 

 

 

36,329

 

 

See notes to consolidated financial statements.

- 74 -


MEDPACE HOLDINGS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

 

 

 

 

 

 

 

 

 

(Amounts in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Net income

 

$

73,185

 

 

$

39,122

 

 

$

13,425

 

Other comprehensive (loss) income

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments, net of taxes

 

 

(1,783

)

 

 

3,008

 

 

 

(1,183

)

Comprehensive income

 

$

71,402

 

 

$

42,130

 

 

$

12,242

 

 

See notes to consolidated financial statements.

- 75 -


MEDPACE HOLDINGS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

 

(Amounts in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

(Accumulated

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Deficit)

 

 

Other

 

 

 

 

 

 

 

Common

 

 

Treasury

 

 

Paid-In

 

 

Retained

 

 

Comprehensive

 

 

 

 

 

 

 

Stock

 

 

Stock

 

 

Capital

 

 

Earnings

 

 

Income (Loss)

 

 

Total

 

BALANCE — January 1, 2016

 

$

326

 

 

$

-

 

 

$

438,716

 

 

$

(23,009

)

 

$

(2,559

)

 

$

413,474

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13,425

 

 

 

 

 

 

 

13,425

 

Foreign currency translation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,183

)

 

 

(1,183

)

Stock-based compensation expense

 

 

1

 

 

 

 

 

 

 

2,776

 

 

 

 

 

 

 

 

 

 

 

2,777

 

Stock options exercised

 

 

 

 

 

 

 

 

 

 

678

 

 

 

 

 

 

 

 

 

 

 

678

 

Issuance of common stock

 

 

80

 

 

 

 

 

 

 

173,498

 

 

 

 

 

 

 

 

 

 

 

173,578

 

Common stock issuance costs

 

 

 

 

 

 

 

 

 

 

(2,719

)

 

 

 

 

 

 

 

 

 

 

(2,719

)

Reclassification of liability classified stock options upon IPO

 

 

 

 

 

 

 

 

 

 

10,463

 

 

 

 

 

 

 

 

 

 

 

10,463

 

Tax effect of initial public offering related costs

 

 

 

 

 

 

 

 

 

 

192

 

 

 

 

 

 

 

 

 

 

 

192

 

Tax benefit from stock-based compensation

 

 

 

 

 

 

 

 

 

 

25

 

 

 

 

 

 

 

 

 

 

 

25

 

BALANCE — December 31, 2016

 

$

407

 

 

$

-

 

 

$

623,629

 

 

$

(9,584

)

 

$

(3,742

)

 

$

610,710

 

Impact to Retained Earnings from adoption of ASU 2016-09

 

 

 

 

 

 

 

 

 

 

440

 

 

 

(440

)

 

 

 

 

 

 

 

 

BALANCE — January 1, 2017

 

 

407

 

 

 

-

 

 

 

624,069

 

 

 

(10,024

)

 

 

(3,742

)

 

 

610,710

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

39,122

 

 

 

 

 

 

 

39,122

 

Foreign currency translation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,008

 

 

 

3,008

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

4,463

 

 

 

 

 

 

 

 

 

 

 

4,463

 

Stock options exercised

 

 

1

 

 

 

 

 

 

 

1,811

 

 

 

 

 

 

 

 

 

 

 

1,812

 

Repurchases of common stock

 

 

(51

)

 

 

 

 

 

 

 

 

 

 

(149,500

)

 

 

 

 

 

 

(149,551

)

Treasury stock purchases

 

 

(2

)

 

 

(6,030

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,032

)

Tax effect of initial public offering related costs

 

 

 

 

 

 

 

 

 

 

(2

)

 

 

 

 

 

 

 

 

 

 

(2

)

BALANCE — December 31, 2017

 

$

355

 

 

$

(6,030

)

 

$

630,341

 

 

$

(120,402

)

 

$

(734

)

 

$

503,530

 

Impact to Retained Earnings from adoption of ASU 2014-09

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,730

 

 

 

 

 

 

$

5,730

 

BALANCE — January 1, 2018

 

 

355

 

 

 

(6,030

)

 

 

630,341

 

 

 

(114,672

)

 

 

(734

)

 

 

509,260

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

73,185

 

 

 

 

 

 

 

73,185

 

Foreign currency translation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,783

)

 

 

(1,783

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

6,499

 

 

 

 

 

 

 

 

 

 

 

6,499

 

Stock options exercised

 

 

1

 

 

 

 

 

 

 

2,541

 

 

 

 

 

 

 

 

 

 

 

2,542

 

BALANCE — December 31, 2018

 

$

356

 

 

$

(6,030

)

 

$

639,381

 

 

$

(41,487

)

 

$

(2,517

)

 

$

589,703

 

 

See notes to consolidated financial statements.

- 76 -


MEDPACE HOLDINGS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

 

 

 

 

 

 

 

(Amounts in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

73,185

 

 

$

39,122

 

 

$

13,425

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation

 

 

9,240

 

 

 

8,574

 

 

 

7,442

 

Amortization

 

 

29,561

 

 

 

37,900

 

 

 

50,672

 

Stock-based compensation expense

 

 

6,499

 

 

 

4,463

 

 

 

9,815

 

Amortization of debt issuance costs and discount

 

 

615

 

 

 

662

 

 

 

2,576

 

Loss on extinguishment of debt

 

 

-

 

 

 

-

 

 

 

10,726

 

Deferred income tax provision (benefit)

 

 

3,942

 

 

 

3,237

 

 

 

(9,006

)

Amortization and adjustment of deferred credit

 

 

(7,712

)

 

 

(8,781

)

 

 

-

 

Other

 

 

1,653

 

 

 

(673

)

 

 

(1,019

)

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable and unbilled, net

 

 

(27,047

)

 

 

(2,898

)

 

 

(13,727

)

Prepaid expenses and other current assets

 

 

(1,241

)

 

 

(3,533

)

 

 

(3,661

)

Accounts payable

 

 

1,342

 

 

 

4,816

 

 

 

691

 

Accrued expenses

 

 

29,029

 

 

 

(1,313

)

 

 

4,516

 

Pre-funded study costs

 

 

-

 

 

 

5,292

 

 

 

5,400

 

Advanced billings

 

 

35,593

 

 

 

7,735

 

 

 

14,723

 

Other assets and liabilities, net

 

 

1,925

 

 

 

2,782

 

 

 

(841

)

Net cash provided by operating activities

 

 

156,584

 

 

 

97,385

 

 

 

91,732

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

Property and equipment expenditures

 

 

(16,024

)

 

 

(11,724

)

 

 

(13,537

)

Acquisition of intangibles

 

 

-

 

 

 

(569

)

 

 

-

 

Other

 

 

(949

)

 

 

56

 

 

 

115

 

Net cash used in investing activities

 

 

(16,973

)

 

 

(12,237

)

 

 

(13,422

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

Payment for common stock issuance costs

 

 

-

 

 

 

-

 

 

 

(2,719

)

Proceeds from stock option exercises

 

 

2,489

 

 

 

1,812

 

 

 

537

 

Repurchases of common stock

 

 

-

 

 

 

(155,583

)

 

 

-

 

Excess tax benefit from stock-based compensation

 

 

-

 

 

 

-

 

 

 

25

 

Proceeds from issuance of debt, net of original issue discount

 

 

-

 

 

 

-

 

 

 

164,506

 

Payment of debt

 

 

(72,188

)

 

 

(12,375

)

 

 

(390,060

)

Proceeds from revolving loan

 

 

-

 

 

 

100,000

 

 

 

-

 

Payments on revolving loan

 

 

(70,000

)

 

 

(30,000

)

 

 

-

 

Debt issuance costs

 

 

-

 

 

 

-

 

 

 

(1,802

)

Payment of deemed landlord liability

 

 

(1,881

)

 

 

(1,682

)

 

 

(1,525

)

Payment on debt extinguishment

 

 

-

 

 

 

-

 

 

 

(548

)

Proceeds from common stock issued, net

 

 

-

 

 

 

-

 

 

 

173,578

 

Net cash used in financing activities

 

 

(141,580

)

 

 

(97,828

)

 

 

(58,008

)

EFFECT OF EXCHANGE RATES ON CASH,

CASH EQUIVALENTS, AND RESTRICTED CASH

 

 

(1,241

)

 

 

1,765

 

 

 

(632

)

(DECREASE) INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH

 

 

(3,210

)

 

 

(10,915

)

 

 

19,670

 

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — Beginning of period

 

 

26,492

 

 

 

37,407

 

 

 

17,737

 

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — End of period

 

$

23,282

 

 

$

26,492

 

 

$

37,407

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION—

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid during the period for income taxes

 

$

23,311

 

 

$

17,180

 

 

$

17,654

 

Cash paid during the period for interest

 

$

7,589

 

 

$

6,888

 

 

$

16,895

 

Acquisition of property and equipment—non-cash

 

$

1,551

 

 

$

678

 

 

$

1,687

 

See notes to consolidated financial statements.

- 77 -


MEDPACE HOLDINGS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

As of December 31, 2018 and 2017, and for the Years Ended December 31, 2018, 2017 and 2016

 

1. BASIS OF PRESENTATION

Description of Business

Medpace Holdings, Inc. together with its subsidiaries, (“Medpace” or the “Company”), a Delaware corporation, is a global provider of clinical research-based drug and medical device development services. The Company partners with pharmaceutical, biotechnology, and medical device companies in the development and execution of clinical trials. The Company’s drug development services focus on full service Phase I-IV clinical development services and include development plan design, coordinated central laboratory, project management, regulatory affairs, clinical monitoring, data management and analysis, pharmacovigilance new drug application submissions, and post-marketing clinical support. The Company also provides bio-analytical laboratory services, clinical human pharmacology, imaging services, and electrocardiography reading support for clinical trials.

The Company’s operations are principally based in North America, Europe, and Asia.

Share Repurchases

In November 2017, the Board members who are not affiliated with Cinven (the “Disinterested Directors”) approved an agreement to repurchase 2,000,000 shares of the Company’s common stock from Cinven in connection with the Secondary Offering (as described below) for aggregate consideration of approximately $60.3 million, representing a purchase price of $30.16 per share. The Company funded the repurchase with approximately $60.0 million in borrowings under the Senior Secured Revolving Credit Facility and cash on hand.

In August 2017, the Disinterested Directors of the Company approved a stock repurchase agreement with Medpace Limited Partnership, a Guernsey limited partnership (the “Limited Partnership” acting through its general partner, Medpace GP Limited, a Guernsey company, the “General Partner” and, the Limited Partnership acting through the General Partner, “Cinven”), pursuant to which the Company repurchased 2,000,000 shares of the Company’s common stock from Cinven for aggregate consideration of approximately $60.5 million, representing a purchase price of $30.27 per share. The Company funded the repurchase with cash on hand and $40.0 million in borrowings under our Senior Secured Revolving Credit Facility.

In April 2017, the Board of the Company authorized a share repurchase program with an authorized repurchase level of $50.0 million. The share repurchase program was cancelled in the fourth quarter of 2017. Repurchases under the repurchase program took place in the open market or negotiated transactions, at the discretion of the Company’s management. During the year ended December 31, 2017, the Company repurchased 1,342,786 shares of its outstanding common stock for $34.7 million under this share repurchase program.

The Company has elected to constructively retire all repurchased shares with all amounts paid in excess of Common stock par value reflected within Accumulated deficit in the Company’s consolidated balance sheets, except for 200,000 shares, which are reflected within treasury stock in the Company’s consolidated balance sheets.

Initial Public Offering

On August 11, 2016, the Company's common stock began trading on the NASDAQ Global Select Market (“NASDAQ”) under the symbol "MEDP". On August 16, 2016, the Company completed its initial public offering (“IPO”) of its common stock at a price to the public of $23.00 per share. The Company issued and sold 8,050,000 shares of common stock in the IPO, including 1,050,000 common shares issued pursuant to the full exercise of the underwriters' option to purchase additional shares. The IPO raised net proceeds of approximately $173.6 million after deducting underwriting discounts and commissions. As contemplated in the Company’s prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the “Securities Act”), with the Securities and Exchange Commission on August 11, 2016, the net proceeds from the IPO, along with cash on hand, were used to repay $175.0 million of outstanding borrowings under the 2014 Senior Secured Term Loan Facility (as defined below) and $2.7 million of offering expenses.

- 78 -


Secondary Offerings

During the year ended December 31, 2018, Cinven sold a total of 16,399,997 shares of the Company’s common stock as part of multiple secondary offerings. The Company incurred professional fees in connection with the secondary offerings of $0.7 million during the year ended December 31, 2018. The fees are included within operating expenses in the accompanying consolidated statement of operations. As of August 27, 2018, Cinven does not beneficially own any shares of the Company’s outstanding common stock. The Company did not sell any shares in or receive any proceeds from the secondary offerings.

During the year ended December 31, 2017, Cinven sold a total of 4,600,000 shares of the Company’s common stock as part of a secondary offering. The Company incurred professional fees in connection with the secondary offering of $0.4 million during year ended December 31, 2017. The fees are included within operating expenses in the accompanying consolidated statement of operations.

2. ACQUISITION

In May 2017, the Company acquired out of bankruptcy NephroGenex, Inc. (“Nephrogenex” or the “Debtor”), a publicly-held pharmaceutical company that had previously filed for relief under Chapter 11 of the United States Bankruptcy Code. The Company, which was the largest unsecured creditor of Nephrogenex, entered into an agreement through the bankruptcy process, to exchange its unsecured claim for 100% of the common stock in the post-bankruptcy, debt-free Debtor. The assets of the acquired Debtor consist primarily of tax attributes as well as in-process research and development and other intangible assets.  An analysis by the Company determined that substantially all the fair value of the assets on the date of acquisition is captured in the tax attributes, as the intangible assets account for a relatively immaterial portion of the fair market value of the total assets received. The acquisition of the Debtor was accounted for as an asset purchase.

The Company allocated its consideration paid of $1.2 million, consisting of accounts receivable and unbilled receivables and transaction related costs, on a pro rata basis to the assets acquired based on their respective fair values. Acquired assets include intangible assets of $0.5 million, deferred tax assets of $22.2 million, consisting of tax effected net operating losses in the amount of $13.5 million, tax effected capitalized research and development expenses of $8.5 million and tax effected federal tax credits of $0.2 million, and deferred tax liabilities of $0.1 million. The excess amount of fair value received over consideration paid of $21.4 million was recorded as a Deferred credit in the consolidated balance sheets and is recognized within income tax provision in proportion to the realization of the deferred tax assets and federal tax credits prospectively.

During the fourth quarter of the year ended December 31, 2017, the Deferred tax assets and related Deferred credit balances were revalued due primarily to the impact of tax reform. See Note 12 of the Notes to Consolidated Financial Statements for further discussion of the impact of tax reform on our consolidated financial statements. Additionally, in 2018, the Company disposed of approximately $7.4 million in deferred tax assets and reduced the Deferred credit by approximately $6.9 million as a result of an IRC Section 382 ownership shift that occurred as a result of Cinven’s sales of the Company’s securities. The ownership shift resulted in a limitation in the ability to utilize the acquired tax attributes and resulted in the described asset write-off and reduction of the Deferred credit.

3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation and Presentation

The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and include the accounts and operations of the Company and its subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from these estimates.

- 79 -


Significant items that are subject to management estimates and assumptions include revenue, net, allowances for doubtful accounts, acquisition purchase price allocations, long-lived asset impairment and useful lives, exit liabilities, stock-based compensation, uncertain income tax positions and contingencies.

Reportable Segments

The Company emphasizes its full service outsourcing model, providing services focused on the development, management and execution of clinical trials. As part of this full service approach, the Company utilizes centralized systems, customer interface technology, support functions and processes that cross service offerings and align resources to deliver efficient clinical trial services. Given the full service approach, the chief executive officer, who is the chief operating decision maker (“CODM”) assesses the allocation of resources based on key metrics including revenue, backlog, and net awards by service offering and consolidated profitability and consolidated cash flows. Based on the Company’s full service model, internal management and reporting structure, and key metrics used by the CODM to make resource allocation decisions, management has determined that the Company’s operations consist of a single operating segment. Therefore, results of operations are presented as a single reportable segment.

Foreign Currencies

Assets and liabilities recorded in foreign currencies on foreign subsidiary financial statements are translated at the exchange rate on the balance sheet date, while equity accounts are translated at historical exchange rates. Revenue and expenses are recorded at average rates of exchange during the year. Translation adjustments are recorded to Accumulated other comprehensive loss in the consolidated statements of shareholders’ equity and consolidated statements of comprehensive income.

Separately, net realized gains and losses on foreign currency transactions are included in Miscellaneous income (expense), net, on the consolidated statements of operations. Foreign currency transactions resulted in a net gain of $0.4 million during the year ended December 31, 2018 and net losses of $1.0 million and $0.7 million during the years ended December 31, 2017 and 2016, respectively.

Revenue Recognition

The Company generally enters into contracts with customers to provide services ranging in duration from a few months to several years. The contract terms generally provide for payments based on a fixed fee or unit-of-service arrangement. The Company accounts for revenue in accordance with ASC 606, Revenue from Contracts with Customers, which the Company adopted on January 1, 2018 using the modified retrospective implementation method. Revenue on contracts is recognized when or as the Company satisfies the contract performance obligations, at the amount that reflects the Company’s cumulative progress toward delivery of the performance obligation. This progress assessment is applied to the amount of consideration to which the Company expects to be paid for delivery of the performance obligation. The Company’s performance obligations are generally satisfied over time and related revenue is recognized as services are provided to meet these obligations.

Contract Assumptions

An arrangement is accounted for as a contract within the scope of ASC 606 when the Company and its customers approve the contract, are committed to perform their respective obligations, each party can identify its rights regarding the goods or services to be transferred, commercial substance is present, and it is probable that the Company will collect substantially all of the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer.  

For the Company’s services to meet this criteria, contracts generally need to be written, pending regulatory hurdles required to commence work must be cleared, the study protocol must be completed, the customer must have adequate funding or reasonable path to funding to execute the contracted portion of the study, and the study must be actively moving forward. Once these criteria have been met, it is deemed that the Company and its customers are committed to perform their respective obligations. Depending on the timing of when these criteria are met, revenue recognition may vary significantly on a period over period basis.      

- 80 -


Accounting for contracts performed over a period of time involves the use of various assumptions to estimate total contract revenue and costs. The Company estimates expected costs to complete a contract and recognizes contracted revenue over the life of the contract as those costs are incurred.

Cost estimates are based on a detailed project budget and are developed based on many variables, including, but not limited to, the scope of the work, the complexity of the study, the participating geographic locations and the Company’s historical experience. To assist with the estimation of costs expected at completion over the life of a project, regular contract reviews are performed in which performance to date is compared to the most current estimate to complete assumptions. The reviews include an assessment of costs incurred to date compared to expectations based on budget assumptions and other circumstances specific to the project. The total estimated costs necessary to complete is updated and any revisions to the existing cost estimate results in cumulative adjustments to the amount of revenue recognized in the period in which the revisions are identified. In the case of cost estimates related to activities legally contracted as reimbursable in nature, including but not limited to investigator fee activity, these estimates also influence the Company’s assumed contract value and assumed remaining performance obligations. Because of the uncertainties inherent in estimating the costs necessary to fulfill contractual obligations, it is possible that estimates may change in the near term, resulting in a material change in revenue reported.

Contracts generally provide for pricing modifications upon scope of work changes. The Company recognizes revenue, at an amount to which it expects to be entitled, related to work performed in connection with scope changes when the underlying services are performed and a binding contractual commitment has been established with the customer. If the Company’s customers do not agree to contract changes upon changes in the Company’s scope of work, the Company could be exposed to cost overruns and reduced contract profitability. Costs are not deferred in anticipation of contracts being awarded or amendments being finalized, but are expensed as incurred.

Most contracts are terminable by the customer, either immediately or according to advance notice terms specified within the contracts. These contracts require payment of fees for services rendered through the date of termination and may require payment for subsequent services necessary to conclude the study or close out the contract. Final settlement amounts are agreed to with the customer based on remaining work to be performed. These amounts are included in revenue when the Company believes the amount can be estimated reliably and its realization is probable.  In evaluating the probability of recognition, the Company considers the contractual basis for the settlement amount and the objective evidence available to support the amount.

Certain contracts contain volume rebate arrangements with our customers that provide for rebates if certain specified spending thresholds are met. These obligations are considered as a reduction in revenue when it appears probable that the arrangement thresholds will be met, which can be at contract inception. Total revenue is presented net of rebates of $1.2 million, $0.2 million and less than $0.1 million in the consolidated statements of operations during the years ended December 31, 2018, 2017 and 2016, respectively.

The Company occasionally enters into incentive fee arrangements with customers that provide for additional compensation if certain defined contractual milestones or performance thresholds are met. These additional fees are included in the estimated transaction price when there is a basis to reasonably estimate the amount of the fee and when achievement of the incentive milestone is deemed probable.  These estimates are based on anticipated performance, the Company’s best judgment at the time or ultimately, upon achievement of the threshold or milestone.

The Company records revenue net of any tax assessments by governmental authorities that are imposed and concurrent with specific revenue generating transactions.

Performance Obligations

Substantially all of the Company’s contracts consist of a single performance obligation, as the promise to transfer the individual services described in the contracts are not separately identifiable from other promises in the contracts, and therefore not distinct. Revenue recognition is determined by assessing the progress of performance completed or delivered to date compared to total services to be delivered under the terms of the arrangement. The measures utilized to assess progress on the satisfaction of performance are specific to the performance obligation identified in the contract.  

- 81 -


For the majority of the Company’s contract performance obligations, it utilizes the input method of cost to cost to measure progress, as the Company has determined that it is the most consistent measure of progress among contract tasks and represents the most faithful depiction of the transfer of services over the contract life. Under this method, the Company determines cost incurred to date for the services it provides compared to the total estimated costs at completion.  

For certain other contractual performance obligations, the Company has determined that an output method is the best measure of progress. These relate to certain unitized contracts, and the Company recognizes revenue in the period in which the unit is delivered compared to total contracted units.

On December 31, 2018, the Company had approximately $1,060.7 million of performance obligations remaining to be performed for active projects.  

Concentration of Credit Risk

Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents and accounts receivable. The cash and cash equivalent balances are held and maintained with financial institutions with reputable credit ratings and, consequently, the Company believes that such funds are subject to minimal credit risk.

The Company generally does not require collateral or other securities to support customer receivables. In the years ended December 31, 2018, 2017 and 2016, credit losses have been immaterial and within management’s expectations. At December 31, 2018 and 2017, there were no customers accounting for more than 10% of the Company’s accounts receivable.

Costs and Expenses

The Company incurs costs associated with service delivery including direct labor and related employee benefits, laboratory supplies, and other expenses. These costs are recorded in Direct service costs, excluding depreciation and amortization as a component of Total direct costs in the accompanying consolidated statements of operations. In addition, the Company incurs expenses on behalf of its customers for various project expenditures including, but not limited to, investigator site payments, travel, meetings, printing, and shipping and handling fees that are reimbursed by its customers at cost. These costs are included in Reimbursable out-of-pocket expenses as a component of Total direct costs in the accompanying consolidated statements of operations. Total direct costs are expensed as incurred and are not deferred in anticipation of contracts being awarded or finalization of changes in scope. Selling, general and administrative includes administrative payroll and related employee benefits, sales and marketing expenses, administrative travel, and other expenses not directly related to service delivery. Rent, utilities, supplies, and software license expenses are allocated between Total direct costs, and Selling, general and administrative based on the estimated contribution among service delivery and support function efforts on a percentage basis. Depreciation and amortization is reported separately in the accompanying consolidated statements of operations. Costs of sales and marketing activities not subject to recovery pursuant to customer contracts, such as feasibility assessments and negotiation of contracts, are expensed as incurred and recorded as a component of Selling, general and administrative in the accompanying consolidated statements of operations.

Advertising expenses are recorded as a component of Selling, general and administrative expenses in the accompanying consolidated statements of operations. Total advertising expenses of $0.8 million, $0.6 million and $0.6 million were incurred during the years ended December 31, 2018, 2017 and 2016, respectively.

Prior to the adoption of Accounting Standard Update No. 2014-09 ‘‘Revenue from Contracts with Customers”, fees paid to investigators and other disbursements in which the Company acts as an agent on behalf of the customer were recorded net in the consolidated statements of operations with no impact on the Company’s revenue or expenses. Funds received in advance of study expenditures were recorded as Pre-funded study cost liabilities on the consolidated balance sheets. Any pre-funded amounts remaining at the conclusion of a study were returned to the client. Pre-funded study cost disbursements of $138.7 and $150.3 million were made during the years ended December 31, 2017 and 2016, respectively.

- 82 -


Income Taxes

The Company’s consolidated U.S. federal income tax return is comprised of its U.S. subsidiaries and one of its foreign subsidiaries located in Korea. All foreign subsidiaries of the Company file tax returns in their local jurisdictions.

The Company provides for income taxes on all transactions that have been recognized in the consolidated financial statements in accordance with accounting guidance governing income tax accounting. Accordingly, the impact of changes in income tax laws on deferred tax assets and deferred tax liabilities are recognized in net earnings in the period during which such changes are enacted.

The Company records deferred tax assets and liabilities based on temporary differences between the financial statement bases and tax bases of assets and liabilities. Deferred tax assets are recorded for tax benefit carryforwards using tax rates anticipated to be in effect in the year in which the temporary differences are expected to reverse. If it does not appear more likely than not that the full value of a deferred tax asset will be realized, the Company records a valuation allowance against the deferred tax asset, with an offsetting charge to the Company’s income tax provision or benefit. The value of the Company’s deferred tax assets is estimated based on, among other things, the Company’s ability to generate a sufficient level of future taxable income. In estimating future taxable income, the Company has considered both positive and negative evidence, such as historical and forecasted results of operations, and has considered the implementation of prudent and feasible tax planning strategies.

The Company’s current accounting position is that unremitted foreign earnings are indefinitely reinvested. Therefore, the Company has not recorded deferred foreign withholding taxes on the unremitted foreign earnings. Refer to Note 12 for further information regarding this assertion.

The Company follows accounting guidance related to accounting for uncertainty in income taxes which requires significant judgment in determining what constitutes an individual tax position as well as assessing the possible outcome of each tax position. Changes in judgments as to recognition or measurement of tax positions can materially affect the estimate of the effective tax rate, and, consequently, the Company’s consolidated financial results. The Company considers many factors when evaluating and estimating tax positions and tax benefits, which may require periodic adjustments and which may not accurately anticipate actual outcomes. In addition, the calculation of tax liabilities involves dealing with uncertainties in the application of complex tax regulations in a multitude of jurisdictions. The Company determines its liability for uncertain tax positions globally. If the payment of these amounts ultimately proves to be unnecessary, the reversal of liabilities would result in tax benefits being recognized in the period when it is determined the liabilities are no longer necessary. If the calculation of the liability related to uncertain tax positions proves to be more or less than the ultimate assessment, a tax expense or tax benefit would result. Interest and penalties associated with uncertain tax positions are recognized as components of the Company’s Income tax provision.

Research and Development Credits

Research and development credits are available to the Company under tax laws in certain jurisdictions, based on qualifying research and development spend as defined under those tax laws. Certain tax jurisdictions provide refundable credits that are not wholly dependent on the Company’s income tax status or income tax position. In these circumstances the benefit of the credits is recorded as a reduction of operating expense. When they are wholly dependent upon the Company’s income tax position, research and development credits are recognized as a reduction of income tax expense.

Stock-Based Compensation

The Company has stock-based employee compensation plans for which it incurs compensation expense.

- 83 -


Equity Awards

In connection with the Company's IPO, the Board approved the formation of the 2016 Incentive Award Plan (the “2016 Plan”), which replaced our 2014 Equity Incentive Plan (the “2014 Plan”). The 2016 Plan provides for long-term equity incentive compensation for key employees, officers and non-employee directors. A variety of discretionary awards (collectively, the “Awards”) for employees and non-employee directors are authorized under the 2016 Plan, including vested common shares, stock options, stock appreciation rights (“SARs”), restricted stock awards (“RSAs”), restricted stock units (“RSUs”), or other cash based or stock dividend equivalent awards. The vesting of such awards may be conditioned upon either a specified period of time or the attainment of specific performance goals as determined by the administrator of the 2016 Plan. The option price and term are also subject to determination by the administrator with respect to each grant. Option prices are generally expected to be set at the market price of our common stock at the date of grant and option terms are not expected to exceed ten years.  All outstanding Awards under the 2016 Plan are equity classified awards.  

The Company created the 2014 Plan, providing for the future issuance of vested shares, stock options, RSAs and RSUs in Medpace Holdings, Inc.’s common stock (the “2014 Plan Awards”). The 2014 Plan Awards were subject to either equity or liability-classification pursuant to the terms of the participant’s award agreement and the 2014 Plan based on accounting guidance which governs such transactions.

Stock-based compensation expense for both the 2016 Plan and 2014 Plan is calculated using the fair value method on the grant date. The Company expenses stock-based compensation using a graded vesting schedule.

For liability-classified awards under the 2014 Plan, the Company recorded fair value adjustments up to and including the settlement date. Changes in the fair value of the stock compensation liability that occurred during the requisite service period were recognized as compensation cost over the vesting period. Changes in the fair value of the stock compensation liability that occurred after the end of the requisite service period but before settlement, were compensation cost of the period in which the change occurred.

As a result of the Company’s IPO, a condition of all outstanding stock options issued before August 10, 2016 under the 2014 Plan that previously required the exchange of the shares issued for incentive units in the equity of a non-consolidated related party was dissolved. All future exercises of options issued pursuant to the 2014 Plan will settle in unregistered shares of the Company. As a result of the modification in the settlement condition, the options are equity-classified instruments and changes in the fair value of the stock compensation liability that occur during the requisite service period are no longer recognized. 

Stock-based compensation expense is allocated between Total direct costs, and Selling, general and administrative in the consolidated statements of operations based on the underlying classification and scope of work for the employees receiving the Awards.

 

Net Income Per Share

Basic and diluted earnings or loss per share (“EPS”) are computed using the two-class method, which is an earnings allocation that determines EPS for each class of common stock and participating securities according to dividends declared and participation rights in undistributed earnings. The Company’s RSAs are considered participating securities because they are legally issued at the date of grant and holders are entitled to receive non-forfeitable dividends during the vesting term.

The computation of diluted EPS includes additional common shares, such as unvested RSUs and stock options with exercise prices less than the average market price of the Company’s common stock during the period (“in-the-money options”), which would be considered outstanding under the treasury stock method. The treasury stock method assumes that additional shares would have to be issued in cases where the exercise price of stock options is less than the value of the common stock being acquired because the cash proceeds received from the stock option holder would not be sufficient to acquire that same number of shares. The Company does not compute diluted EPS in cases where the inclusion of such additional shares would be anti-dilutive in effect.

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The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2018, 2017 and 2016 (in thousands, except for earnings per share):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Weighted-average shares:

 

 

 

 

 

 

 

 

 

 

 

 

Common shares outstanding

 

 

35,547

 

 

 

39,056

 

 

 

35,690

 

RSAs

 

 

142

 

 

 

90

 

 

 

88

 

Total weighted-average shares

 

 

35,689

 

 

 

39,146

 

 

 

35,778

 

Earnings per common share—Basic

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

73,185

 

 

$

39,122

 

 

$

13,425

 

Less: Undistributed earnings allocated to RSAs

 

 

291

 

 

 

90

 

 

 

33

 

Net income available to common shareholders—Basic

 

$

72,894

 

 

$

39,032

 

 

$

13,392

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income per common share—Basic

 

$

2.05

 

 

$

1.00

 

 

$

0.38

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic weighted-average common shares outstanding

 

 

35,547

 

 

 

39,056

 

 

 

35,690

 

Effect of diluted shares

 

 

1,365

 

 

 

783

 

 

 

639

 

Diluted weighted-average shares outstanding

 

 

36,912

 

 

 

39,839

 

 

 

36,329

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income per common share—Diluted

 

$

1.97

 

 

$

0.98

 

 

$

0.37

 

 

For the years ended December 31, 2018, 2017 and 2016, the computation of diluted EPS excludes the effect of (in thousands) 121, 63 and 0 stock options, respectively, due to each respective period’s average fair value of the Company’s common stock not exceeding the exercise prices.  

Fair Value Measurements

The Company follows accounting guidance related to fair value measurements that defines fair value, establishes a framework for measuring fair value, and establishes a hierarchy for inputs used in measuring fair value. This hierarchy maximizes the use of “observable” inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. The hierarchy specifies three levels based on the inputs, as follows:

Level 1: Valuations based on quoted prices in active markets for identical assets or liabilities.

Level 2: Valuations based on directly observable inputs or unobservable inputs corroborated by market data.

Level 3: Valuations based on unobservable inputs supported by little or no market activity representing management’s determination of assumptions of how market participants would price the assets or liabilities.

The fair value of financial instruments such as cash and cash equivalents, accounts receivable and unbilled, net, accounts payable, accrued expenses, and advanced billings approximate their carrying amounts due to their short term maturities.

The Company does not have any recurring fair value measurements as of December 31, 2018. There were no transfers between Level 1, Level 2, or Level 3 during the years ended December 31, 2018, 2017 and 2016.

  

Cash and Cash Equivalents, including Restricted Cash

Cash and cash equivalents, including restricted cash, are invested in demand deposits, all of which have an original maturity of three months or less. Restricted cash consists of customer funds received in advance and subject to

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specific restrictions, as well as amounts placed in escrow for contingent payments resulting from acquisitions or other contractual arrangements.

Accounts Receivable and Unbilled, Net

Accounts receivable represent amounts due from the Company’s customers who are concentrated primarily in the pharmaceutical, biotechnology, and medical device industries. Unbilled services represent revenue recognized to date that is currently not billable to the customer pursuant to contractual terms. In general, amounts become billable upon the achievement of negotiated contractual events or in accordance with predetermined payment schedules. Amounts classified to unbilled services are those billable to customers within one year from the respective balance sheet date.

The Company grants credit terms to its customers prior to signing a service contract and monitors the creditworthiness of its customers on an ongoing basis. The Company maintains an allowance for doubtful accounts based on specific identification of accounts receivable that are at risk of not being collected. Uncollectible accounts receivable are written off only after all reasonable collection efforts have been exhausted. Moreover, in some cases the Company requires advance payment from its customers for a portion of the study contract price upon the signing of a service contract. These advance payments are deferred and recognized as revenue as services are performed.

Inventory

Inventory, which consists primarily of laboratory supplies, is valued at the lower of cost or market. Inventory is stated at purchased cost using the first-in, first out (FIFO) cost method. The inventory balance is included in Prepaid expenses and other current assets in the consolidated balance sheets.

Property and Equipment

Property and equipment is recorded at cost. Depreciation is provided on the straight-line method at rates adequate to allocate the cost of the applicable assets over their estimated useful lives, which is three to five years for computer hardware, software, phone, and medical imaging equipment, five to seven years for furniture and fixtures and other equipment, and thirty to forty years for buildings. The Company capitalizes costs of computer software developed for internal use and amortizes these costs on a straight-line basis over the estimated useful life, not to exceed three years. Leasehold improvements and deemed assets from landlord building construction are capitalized and amortized on a straight-line basis over the shorter of the estimated useful life of the improvement or the associated remaining lease term. Repairs and maintenance are expensed as incurred.

Leases

The Company leases facilities and equipment to be used in its operations, some of which require capitalization in accordance with US GAAP. Upon the execution of new leases, the Company determines the appropriate classification of the lease as operating or capital and reflects the impact of this classification in its consolidated financial statements.

Goodwill and Intangible Assets

Goodwill

Goodwill represents the excess of purchase price over the fair value of net assets acquired in business combinations. The carrying value of goodwill is reviewed at least annually for impairment, or as indicators of potential impairment are identified, at the reporting unit level. The reporting units are Phase II-IV clinical research services, Laboratories, and Clinics as of December 31, 2018.

The Company performs its annual impairment tests during the fourth quarter each year, utilizing the quantitative two step model defined by accounting guidance which governs such assessments. The first step involves the Company comparing each of its reporting unit carrying values, inclusive of assigned goodwill, to their respective estimated

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fair values. Fair value is estimated using a combination of the income approach, a discounted cash flow analysis, and the market approach, utilizing the guideline company method.

If the calculation in the first step results in any of the reporting units’ carrying values exceeding their respective estimated fair values, a second step is performed. The second step requires the Company to allocate the fair value of the reporting unit derived in the first step to the fair value of the reporting unit’s net assets. Any fair value in excess of amounts allocated to such net assets represent the implied fair value of goodwill for that reporting unit. Any excess of reporting unit carrying value of goodwill over the implied fair value of goodwill results in an impairment. There was no indication of impairment related to goodwill based on the fourth quarter 2018 assessment.

Intangible Assets

The Company has an indefinite lived intangible asset related to its trade name. The carrying value of the trade name asset is reviewed at least annually for impairment, or as indicators of potential impairment are identified. The Company performs its annual impairment test in the fourth quarter each year in conjunction with its annual assessment of goodwill. The assessment consists of comparing the carrying value of the indefinite lived intangible asset to its estimated fair value, utilizing the relief from royalty method, an income approach valuation. There was no indication of impairment related to the trade name asset based on the fourth quarter 2018 assessment.

Finite-lived intangible assets consist mainly of the value assigned to customer relationships, backlog and developed technologies. Finite-lived intangible assets are amortized straight-line or using an accelerated method over their estimated useful lives, which range in term from five to fifteen years.

Impairment of Long-Lived Assets

Long-lived assets, primarily property and equipment and finite-lived intangible assets, are reviewed for impairment and the reasonableness of the estimated useful lives whenever events or changes in circumstances indicate that the carrying amounts of the assets may not be recoverable or that a change in useful life may be appropriate. Recoverability for long-lived assets is determined by comparing the forecasted undiscounted cash flows of the operation to which the assets relate to the carrying amount of the assets. If the undiscounted cash flows are less than the carrying amount of the assets, then the Company reduces the carrying value of the assets to estimated fair values, which are primarily based upon forecasted discounted cash flows. Fair value of long-lived assets is determined based on a combination of discounted cash flows and market multiples.

Advanced Billings

Advanced billings represents cash received from customers, or billed amounts per an agreed upon payment schedule, in advance of services being performed or revenue being recognized.

Deemed Landlord Liabilities

Deemed landlord liabilities are recorded at their net present value when the Company enters into qualifying leases and are reduced as the Company makes periodic lease payments on the properties.

Deferred Credit

Deferred credit represents tax credits recognized initially in conjunction with the Nephrogenex asset acquisition that will be recognized within Income tax provision in proportion to the realization of the deferred tax assets and federal tax credits prospectively.

Other Current Liabilities and Other Long-Term Liabilities

Deferred rent represents the cumulative additional portion of rent expense recognized on a straight line basis in conjunction with the Company’s current leases at the balance sheet date. The Company defers incentives received

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from landlords for the purpose of making leasehold improvements. These liabilities are amortized as a component of rent expense over the term of the respective lease.

Exit liabilities, if any exist, are recorded at their net present value to the extent the Company no longer receives any benefit from the related property and when the Company has ceased all use of the property.

Asset retirement obligations, to the extent they exist, are recorded at their net present value and accreted to the Company’s estimate of liability at the time the obligation would be required to be satisfied.

Recently Adopted Accounting Standards

In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2017-01, Business Combinations. The standard changes the definition of a business to assist entities with evaluating when a set of transferred assets and activities is a business. Under the new guidance, an entity first determines whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets. If this threshold is met, the set is not a business. If it’s not met, the entity then evaluates whether the set meets the requirement that a business include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create outputs.  ASU 2017-01 is effective for fiscal years beginning after December 15, 2017, and for interim periods within those fiscal years. The Company, as permitted, early adopted ASU 2017-01 using the prospective method in the second quarter of 2017. ASU 2017-01 was considered in the asset acquisition described in Note 2.  

In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation: Improvements to Employee Share-Based Payment Accounting. The new guidance is intended to simplify certain aspects of accounting for share based payments to employees, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The Company elected to adopt this ASU in the first quarter of 2017 as required. The following summarizes the effects of the adoption on the Company's consolidated financial statements:

 

Income taxes - Upon adoption of this standard, all excess tax benefits and tax deficiencies (including tax benefits of dividends, if distributed, on share-based payment awards) are recognized as income tax expense or benefit in the statement of operations. The tax effects of exercised or vested awards are treated as discrete items in the reporting period in which they occur. As a result, the Company recognized discrete adjustments to income tax expense for the year ended December 31, 2017 of less than $0.1 million related to excess tax benefits. The Company also recognizes excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. The Company applied the prospective adoption approach for any unrecognized excess tax benefits beginning in 2017, which did not result in any cumulative-effect adjustment upon adoption. Prior periods have not been adjusted.

 

Forfeitures - Prior to adoption, share-based compensation expense was recognized on a straight line basis, net of estimated forfeitures, such that expense was recognized only for share-based awards that were expected to vest. A forfeiture rate was estimated annually and revised, if necessary, in subsequent periods if actual forfeitures differed from initial estimates. Upon adoption, the Company no longer applies a forfeiture rate and instead accounts for forfeitures as they occur. The Company applied the modified retrospective adoption approach beginning in 2017 and booked an immaterial cumulative-effect adjustment to additional paid-in-capital and retained earnings within Shareholders’ Equity. Prior periods have not been adjusted.

 

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Statements of Cash Flows - The Company historically accounted for excess tax benefits on the consolidated statements of cash flows as a financing activity. Upon adoption of this standard, excess tax benefits are classified along with other income tax cash flows as an operating activity. The Company elected to adopt this portion of the standard on a prospective basis beginning in 2017. Prior periods have not been adjusted.

 

Earnings Per Share - The Company uses the treasury stock method to compute diluted earnings per share, unless the effect would be anti-dilutive. Under this method, the Company is no longer required to estimate the tax rate and apply it to the dilutive share calculation for determining the dilutive earnings per share. The Company utilized the prospective adoption approach and applied this methodology beginning in 2017. Prior periods have not been adjusted.

Upon adoption, no other aspects of ASU 2016-09 had an effect on the Company's consolidated financial statements or related footnote disclosures.

In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09 ‘‘Revenue from Contracts with Customers,’’ (“ASC 606”) to clarify the principles of recognizing revenue and create common revenue recognition guidance between US GAAP and International Financial Reporting Standards. The new standard became effective for the Company in the first quarter 2018.

Under ASC 606, the majority of the Company’s contracts will have a single performance obligation that is satisfied over time, with revenue recognized based on overall project progress measured as of the financial statement date. This represents a change in the Company’s previous revenue accounting methodology, Accounting Standards Codification Topic 605, Revenue Recognition (“ASC 605”), as a majority of contracts were accounted for under the multiple element arrangement guidance.  Under the previous revenue recognition accounting methodology, certain revenue related to reimbursable expenses was presented either as a separate line item within Reimbursable out-of-pocket revenue or net of related expenses within Service revenue, net in the consolidated statements of operations.  As a result of having a single performance obligation, the Company accounts for all revenue related to reimbursable expenses on a gross basis within a single revenue line item.  Measurement of progress on contracts with customers will generally be based on the input measurement of cost incurred relative to the total expected costs to satisfy the performance obligation.  

The Company elected to utilize the modified retrospective implementation method for its transition to ASC 606 as of January 1, 2018 (the “Implementation Date”). Under this implementation method, the Company recognized the cumulative effect of initially applying the ASC 606 revenue recognition guidance to contracts that were not completed at the Implementation Date. At the Implementation Date, the Company elected to reflect the aggregate effect of all contract modifications that occurred before January 1, 2018 in determining the satisfied and unsatisfied performance obligations and determination of the transaction price.

The cumulative effect adjustment was recorded as a reduction to the opening balance of Accumulated deficit in the consolidated balance sheets in the amount of $5.7 million, with offsetting amounts of $23.9 million to Accounts receivable and unbilled, net, $(1.6) million to Deferred income taxes, $35.1 million to Accrued expenses, $(57.4) million to Pre-funded study costs and $38.9 million to Advanced billings, respectively. The amounts recorded to Accounts receivable and unbilled, net, Deferred income taxes, Accrued expenses, Pre-funded study costs, and Advanced billings reflect differences between revenue recognized and billings to customers by project as well as costs incurred but not settled as of the Implementation Date. The above disclosed cumulative effect adjustments have been revised from the amounts previously disclosed in the Company’s interim financial statements filed on Form 10-Q for the quarterly periods ended March 31, 2018, June 30, 2018 and September 30, 2018 to correct certain immaterial misstatements to the opening balance sheet adoption impact of the standard. The effects of these misstatements were immaterial to the Company’s results of operations.

- 89 -


In connection with the implementation of ASC 606 on the modified retrospective method, the Company is presenting additional information to assist with the comparability of select line items of the current and prior period year to date reporting in its consolidated balance sheets and consolidated statements of operations.  Below the Company has presented the amount by which each financial statement line item is affected in the current reporting period by the application of ASC 606 as compared with the guidance that was in effect before the change (ASC 605).

 

 

Year Ended December 31, 2018

 

 

As Reported

 

 

Adjustments

 

 

As Revised under ASC 605

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Revenue, net

$

704,589

 

 

$

(704,589

)

 

$

-

 

Service revenue, net

 

-

 

 

 

478,063

 

 

 

478,063

 

Reimbursed out-of-pocket revenue

 

-

 

 

 

71,305

 

 

 

71,305

 

           Total revenue

 

704,589

 

 

 

(155,221

)

 

 

549,368

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Direct service costs, excluding depreciation and amortization

 

252,284

 

 

 

-

 

 

 

252,284

 

Reimbursed out-of-pocket expenses

 

236,775

 

 

 

(165,470

)

 

 

71,305

 

           Total direct costs

 

489,059

 

 

 

(165,470

)

 

 

323,589

 

           Total operating expenses

 

603,541

 

 

 

(165,470

)

 

 

438,071

 

Income from operations

 

101,048

 

 

 

10,249

 

 

 

111,297

 

Income before income taxes

 

93,951

 

 

 

10,249

 

 

 

104,200

 

Income tax provision

 

20,766

 

 

 

1,882

 

 

 

22,648

 

Net income

$

73,185

 

 

$

8,367

 

 

$

81,552

 

Net income per share attributable to common shareholders:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

2.05

 

 

$

0.24

 

 

$

2.29

 

Diluted

$

1.97

 

 

$

0.23

 

 

$

2.20

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

35,547

 

 

 

-

 

 

 

35,547

 

Diluted

 

36,912

 

 

 

-

 

 

 

36,912

 

 

 

 

 

 

 

 

 

 

 

 

 

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ASSETS

As of December 31, 2018

 

Current assets:

As Reported

 

 

Adjustments

 

 

As Revised under ASC 605

 

Accounts receivable and unbilled, net

 

133,449

 

 

 

(28,729

)

 

 

104,720

 

Prepaid expenses and other current assets

 

21,383

 

 

 

1,147

 

 

 

22,530

 

           Total current assets

 

178,114

 

 

 

(27,582

)

 

 

150,532

 

Deferred income taxes

 

713

 

 

 

(389

)

 

 

324

 

           Total assets

$

967,933

 

 

$

(27,971

)

 

$

939,962

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

Accrued expenses

 

87,493

 

 

 

(51,109

)

 

 

36,384

 

Pre-funded study costs

 

-

 

 

 

61,156

 

 

 

61,156

 

Advanced billings

 

147,935

 

 

 

(41,732

)

 

 

106,203

 

Other current liabilities

 

4,861

 

 

 

(590

)

 

 

4,271

 

           Total current liabilities

 

257,026

 

 

 

(32,275

)

 

 

224,751

 

Deferred income tax liability

 

439

 

 

 

2,049

 

 

 

2,488

 

Other long-term liabilities

 

12,804

 

 

 

(382

)

 

 

12,422

 

           Total liabilities

 

378,230

 

 

 

(30,608

)

 

 

347,622

 

Shareholders’ equity:

 

 

 

 

 

 

 

 

 

 

 

Accumulated deficit

 

(41,487

)

 

 

2,637

 

 

 

(38,850

)

           Total shareholders’ equity

 

589,703

 

 

 

2,637

 

 

 

592,340

 

           Total liabilities and shareholders’ equity

$

967,933

 

 

$

(27,971

)

 

$

939,962

 

 

CASH FLOWS FROM OPERATING ACTIVITIES:

Year Ended December 31, 2018

 

 

As Reported

 

 

Adjustments

 

 

As Revised under ASC 605

 

Net income

 

73,185

 

 

 

8,367

 

 

 

81,552

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

 

 

 

 

 

 

Deferred income tax provision

 

3,942

 

 

 

4,002

 

 

 

7,944

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

           Accounts receivable and unbilled, net

 

(27,047

)

 

 

4,842

 

 

 

(22,205

)

Prepaid expenses and other current assets

 

(1,241

)

 

 

(1,147

)

 

 

(2,388

)

           Accrued expenses

 

29,029

 

 

 

(15,967

)

 

 

13,062

 

           Pre-funded study costs

 

-

 

 

 

3,782

 

 

 

3,782

 

           Advanced billings

 

35,593

 

 

 

(2,907

)

 

 

32,686

 

           Other assets and liabilities, net

 

1,925

 

 

 

(972

)

 

 

953

 

Net cash provided by operating activities

 

156,584

 

 

 

-

 

 

 

156,584

 

 

Recently Issued Accounting Standards

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASC 842”). The guidance in ASC 842 supersedes the lease recognition requirements in ASC Topic 840, Leases (FAS 13) (“ASC 840”). ASC 842 requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases, along with additional qualitative and quantitative disclosures. ASC 842 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted.

ASC 842 allows by policy election, an entity to choose its transition approach.  Entities must adopt ASC 842 on a either a modified retrospective basis to each prior reporting period presented or through an optional alternative method referred to as the “Comparatives Under ASC 840 Approach” which allows entities to apply the new requirements to only those leases that exist as of January 1, 2019.  The Company has elected to adopt ASC 842 utilizing the Comparatives Under ASC 840 Approach.  Under this approach, the Company will not be required to recast comparative periods when transitioning to the new guidance. The Company will also not be required to

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present comparative period disclosures under the new guidance in the period of adoption and any cumulative catch up adjustment for differences between ASC 842 and ASC 840 will be recorded upon adoption.

ASC 842 also allows for the election of certain practical expedients that are meant to ease the burden of transitioning to ASC 842 while still achieving compliance.  The Company will elect the “package of three” practical expedient allowing the Company to carry forward decisions made and documented under current US GAAP, rather than reassessing all of the Company’s contracts to determine whether they are or contain leases and how they would be classified under ASC 842.  The Company has decided not to elect the hindsight practical expedient, which if elected would require the Company to reassess the lease term and assessment of impairment for all of the Company’s leases using the facts and circumstances known up to the adoption date of the standard.  

The Company continues to evaluate the potential impact of adopting this standard on its business policies, processes and systems, internal control over financial reporting environment, and financial reporting disclosures. The most significant impact of adoption will be the conversion of the Company’s headquarter office buildings that are currently classified as deemed assets and liabilities to leases to be accounted for within the scope of ASC 842. This will result in a cumulative adjustment to retained earnings to account for the difference in the expense recognition at the time of adoption as well as a reclass of the Deemed Landlord Liability and deemed assets within Property and Equipment, net to right of use assets and right of use liabilities. Additionally, all existing operating leases will be recorded on the balance sheet as right-of-use (“ROU”) assets with related obligations for lease payments presented as other current liabilities, and ROU lease liabilities. To the extent we identify financing leases, these will be recorded on the balance sheet as property and equipment, with the related payment obligations recorded as other current liabilities, and other long-term liabilities.  

In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. ASU 2018-02 allows for an entity to elect to reclassify the income tax effects on items within accumulated other comprehensive income resulting from U.S. tax reform to retained earnings. The guidance may be applied either in the period of adoption or retrospectively to each period (or periods) in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act is recognized and is effective for fiscal years beginning after December 15, 2018 with early adoption permitted, including interim periods within those years. The Company will adopt this guidance in the first quarter of 2019 and does not expect a material impact on its consolidated financial statements.

4. CONTRACT ASSETS AND CONTRACT LIABILITIES

Contract assets and liabilities are reflected in the Company’s consolidated balance sheets within the accounts reflected below.  

Contract Assets

Accounts receivable represent amounts due from the Company’s customers who are concentrated primarily in the pharmaceutical, biotechnology, and medical device industries. Unbilled represents revenue recognized to date that has not been billed or is not yet contractually billable to the customer. In general, amounts become billable upon the achievement of negotiated contractual events, in accordance with predetermined payment schedules or when a reimbursable expense has been incurred. Amounts classified to unbilled are those billable to customers within one year from the respective balance sheet date.

Accounts receivable and unbilled, net consisted of the following (in thousands):

 

 

As of

 

 

December 31,

 

 

January 1,

 

 

 

 

 

 

December 31,

 

 

2018

 

 

2018

 

 

Adjustments

 

 

2017

 

Accounts receivable

$

85,120

 

 

$

70,943

 

 

$

15,344

 

 

$

55,599

 

Unbilled receivables

 

49,361

 

 

 

36,696

 

 

 

8,543

 

 

 

28,153

 

Less: allowance for doubtful accounts

 

(1,032

)

 

 

(673

)

 

 

-

 

 

 

(673

)

        Total accounts receivable and unbilled, net

$

133,449

 

 

$

106,966

 

 

$

23,887

 

 

$

83,079

 

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Unbilled receivables increased from $36.7 million at January 1, 2018, which includes adjustments of $8.5 million related to the adoption of ASC 606, to $49.4 million at December 31, 2018. The increase is primarily driven by revenue recognized on certain contracts in advance of customer invoicing.

Contract Liabilities

Advanced billings represents cash received from customers, or billed amounts per an agreed upon payment schedule, in advance of services being performed or revenue being recognized.

Advanced billings consisted of the following (in thousands):

 

 

As of

 

 

December 31,

 

 

January 1,

 

 

 

 

 

 

December 31,

 

 

2018

 

 

2018

 

 

Adjustments

 

 

2017

 

Advanced billings

$

147,935

 

 

$

112,613

 

 

$

38,857

 

 

$

73,756

 

Pre-funded study costs

$

-

 

 

$

-

 

 

$

(57,406

)

 

$

57,406

 

 

 

Advanced billings increased from $112.6 million at January 1, 2018, which includes adjustments of $38.9 million related to the adoption of ASC 606, to $147.9 million at December 31, 2018. The increase is primarily driven by billing and/or collection activity in the year ended December 31, 2018 in advance of revenue being earned for delivery of service obligations.

 

A rollforward of allowance for doubtful account activity is as follows:

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Allowance for doubtful accounts - beginning balance

 

$

(673

)

 

$

(3,222

)

 

$

(1,724

)

Current year provision

 

 

(791

)

 

 

(250

)

 

 

(2,166

)

Write-offs, recoveries and the effects of foreign currency exchange

 

 

432

 

 

 

2,799

 

 

 

668

 

Allowance for doubtful accounts - ending balance

 

$

(1,032

)

 

$

(673

)

 

$

(3,222

)

 

5. PROPERTY AND EQUIPMENT, NET

Property and equipment, net consisted of the following at December 31 (in thousands):

 

 

 

 

 

 

 

2018

 

 

2017

 

Land

 

$

1,240

 

 

$

972

 

Equipment

 

 

15,437

 

 

 

12,171

 

Furniture, fixtures, and leasehold improvements

 

 

20,892

 

 

 

21,280

 

Computer hardware, software, and phone equipment

 

 

11,566

 

 

 

9,571

 

Buildings

 

 

8,145

 

 

 

2,559

 

Deemed assets from landlord building construction

 

 

22,752

 

 

 

22,752

 

Construction-in-progress

 

 

5,334

 

 

 

5,554

 

Property and equipment at cost

 

 

85,366

 

 

 

74,859

 

Less: Accumulated depreciation

 

 

(33,111

)

 

 

(26,120

)

Property and equipment, net

 

$

52,255

 

 

$

48,739

 

 

Depreciation expense, which includes amortization from capital leases, was $9.2 million, $8.6 million and $7.4 million for the years ended December 31, 2018, 2017 and 2016, respectively.

- 93 -


In 2011, Medpace, Inc. entered into two multi-year lease agreements governing the future occupancy of additional office space in Cincinnati, Ohio. The Company assumed occupancy of both spaces during 2012 and began making lease payments at that time. The leases expire in 2027 and the Company has one 10-year option to extend the term of the leases.

In accordance with the accounting guidance related to leases, the Company was deemed in substance to be the owner of the property during the construction phase. The accounting guidance requires that a lessee be considered the owner of a real estate project during the construction period if a related party of the lessee is an owner of the real estate. Given that a related party of Medpace made an equity investment in the lessor, Medpace was considered the owner of the property for accounting purposes during the buildings’ construction. Accordingly, the Company reflected the building and related liabilities as Deemed assets from landlord building construction (“Deemed Assets”) and Deemed landlord liabilities, respectively in the consolidated balance sheets. The Deemed Assets are being fully depreciated, on a straight line basis, over the 15-year term of the lease.

 

6. GOODWILL AND INTANGIBLE ASSETS

Goodwill

Total assets carried on the balance sheet and not remeasured to fair value on a recurring basis, identified as Level 3 measurements, as of December 31, 2018 are $692.6 million, comprised of $661.0 million of goodwill and $31.6 million of identified indefinite-lived intangible assets. Accumulated goodwill impairment losses to date amounts to $9.3 million, all of which was recognized in 2015.

Intangible Assets, Net

Intangible assets, net consisted of the following at December 31 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2018

 

 

2017

 

Intangible assets:

 

 

 

 

 

 

 

 

Finite-lived intangible assets:

 

 

 

 

 

 

 

 

Carrying amount:

 

 

 

 

 

 

 

 

Backlog

 

$

72,630

 

 

$

72,630

 

Customer relationships

 

 

145,051

 

 

 

145,051

 

Developed technologies

 

 

54,475

 

 

 

54,475

 

Other

 

 

3,074

 

 

 

3,074

 

Total finite-lived intangible assets

 

 

275,230

 

 

 

275,230

 

Accumulated amortization:

 

 

 

 

 

 

 

 

Backlog

 

 

(72,630

)

 

 

(72,630

)

Customer relationships

 

 

(110,636

)

 

 

(92,661

)

Developed technologies

 

 

(51,751

)

 

 

(40,856

)

Other

 

 

(2,680

)

 

 

(1,989

)

Total accumulated amortization

 

 

(237,697

)

 

 

(208,136

)

Total finite-lived intangible assets, net

 

 

37,533

 

 

 

67,094

 

Trade name (indefinite-lived)

 

 

31,646

 

 

 

31,646

 

Total intangible assets, net

 

$

69,179

 

 

$

98,740

 

 

- 94 -


As of December 31, 2018, estimated amortization expense of the Company’s intangible assets for each of the next five years and thereafter is as follows (in thousands):

 

 

 

 

 

 

2019

 

$

14,829

 

2020

 

 

7,876

 

2021

 

 

5,114

 

2022

 

 

3,353

 

2023

 

 

2,199

 

Later years

 

 

4,162

 

 

 

$

37,533

 

 

7. ACCRUED EXPENSES

Accrued expenses consisted of the following at December 31 (in thousands):

 

 

 

2018

 

 

2017

 

Employee compensation and benefits

 

$

31,344

 

 

$

19,707

 

Project related reimbursable expenses

 

 

51,109

 

 

 

-

 

Other

 

 

5,040

 

 

 

3,966

 

Total accrued expenses

 

$

87,493

 

 

$

23,673

 

 

8. DEBT

Debt consisted of the following at December 31 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2018

 

 

2017

 

 

 

 

 

 

 

 

 

 

Revolving credit facility

 

$

-

 

 

$

70,000

 

Term loan

 

 

80,438

 

 

 

152,625

 

Less unamortized discount

 

 

(282

)

 

 

(399

)

Less unamortized term loan debt issuance costs

 

 

(435

)

 

 

(615

)

Less current portion of long-term debt

 

 

-

 

 

 

(16,500

)

Long-term debt, net, less current portion

 

$

79,721

 

 

$

205,111

 

 

Principal payments on debt are due as follows (in thousands):

 

2019

 

 

-

 

2020

 

 

-

 

2021

 

 

80,438

 

Total

 

$

80,438

 

 

The estimated fair value of the Company’s debt based on Level 2 inputs using the market approach, which is primarily based on rates at which the debt is traded among financial institutions, approximates carrying value as of December 31, 2018 and 2017, respectively.

2016 Credit Agreement

On December 8, 2016 (the “Closing Date”), Medpace IntermediateCo, Inc., as borrower (the “Borrower”), and Medpace Acquisition, Inc., a wholly-owned subsidiary of Medpace Holdings, Inc. (the “Company”), as parent

- 95 -


guarantor (the “Parent Guarantor”), entered into a credit agreement (the “Senior Secured Credit Agreement”) consisting of a $165.0 million term loan (the “Senior Secured Term Loan Facility”) issued at 99.7% and a $150.0 million revolving credit facility (the “Senior Secured Revolving Credit Facility” and, together with the Senior Secured Term Loan Facility, the “Senior Secured Credit Facilities”). The Senior Secured Term Loan Facility and Senior Secured Revolving Credit Facility expire in December 2021.

The Senior Secured Credit Facilities provide for, at the Company’s option, interest at the Eurocurrency rate or Base rate for the Senior Secured Term Loan Facility and the Senior Secured Revolving Credit Facility borrowings. The Company, at its discretion, may choose interest periods of one, two, three or six months, which determines the interest rate to be applied. Interest on Eurocurrency loans continues to be payable at the end of the selected Eurocurrency term and interest on Base rate loans are payable quarterly in conjunction with any required principal payments.

Borrowings under the Senior Secured Credit Facilities bear interest at a rate equal to, at our option, either (i) the adjusted Eurocurrency rate based on LIBOR for U.S. dollar deposits for loans denominated in dollars, EURIBOR for Euro deposits for loans denominated in Euros and the offer rate for any other currencies for loans denominated in such other currencies for the relevant interest period plus an applicable margin from 1.25% to 2.25% based on the total net leverage ratio from less than 1.50:1.00 to greater than 3.75:1:00, or (ii) an alternative base rate (determined by reference to the highest of (a) the prime commercial lending rate of the administrative agent, as established from time to time, (b) the Federal Funds Rate plus 0.50% and (c) the one-month adjusted Eurocurrency rate for loans in U.S. dollars plus 1.00%) plus an applicable margin from 0.25% to 1.25% based on the total net leverage ratio from less than 1.50:1.00 to greater than 3.75:1:00.  The applicable margin as of December 31, 2018 was 1.25% for eurocurrency loans and 0.25% for base rate loans. The Company may voluntarily prepay outstanding loans under the Senior Secured Credit Facilities without premium or penalty. As of December 31, 2018, the interest rate applicable on the term loan was the Eurocurrency interest rate of 3.77%.

In addition, the Company is required to pay to the lenders a commitment fee on a quarterly basis at an annual rate of 0.375% of the unused borrowings under the Senior Secured Revolving Credit Facility for the first full fiscal quarter after the closing date, and thereafter 0.50% if the total net leverage ratio is greater than or equal to 3.00:1.00, or 0.375% if the total net leverage ratio is less than 3.00:1.00. At December 31, 2018 and 2017, respectively, the Company had no outstanding borrowings and $70.0 million outstanding borrowings under the Senior Secured Revolving Credit Facility, resulting in $149.8 million and $80.0 million in undrawn capacity available under the Senior Secured Revolving Credit Facility. As of December 31, 2018, the interest rate applicable on the Senior Secured Revolving Credit Facility was the Eurocurrency interest rate of 3.77%. In addition, the Company had $0.2 million and $0.3 million in letters of credit outstanding, which are secured by the Senior Secured Revolving Credit Facility at December 31, 2018 and 2017, respectively.

The original issue discount of $0.5 million related to the issuance of the Senior Secured Term Loan Facility was recorded as a reduction of the underlying debt issuances within Long-term debt, net, less current portion and is being amortized over the life of the debt using the effective-interest method. The unamortized portion of the discount related to the Senior Secured Term Loan Facility was $0.3 million and $0.4 million as of December 31, 2018 and 2017, respectively. Per the terms of the Senior Secured Credit Term Loan Facility, principal is scheduled to be paid quarterly on the last business day of March, June, September and December of each year, beginning March 2017.

Origination fees of $0.8 million related to the Senior Secured Term Loan Facility were recorded as a reduction of the underlying debt issuances in Long-term debt, net. These fees are being amortized over the life of the debt using the effective-interest method. The unamortized portion of the origination fees related to the Senior Secured Term Loan Facility was $0.4 million and $0.6 million at December 31, 2018 and 2017, respectively.  Origination fees of $1.6 million related to the Senior Secured Revolving Credit Facility were originally capitalized as a component of Other assets. These fees are being amortized over the life of the debt using the effective-interest method. The unamortized portion of the origination fees related to the Senior Secured Revolving Credit Facility was $0.9 million and $1.3 million at December 31, 2018 and 2017, respectively.

The Senior Secured Credit Facilities are guaranteed by the Parent Guarantor and its material, direct or indirect wholly owned domestic subsidiaries, with certain exceptions, including where providing such guarantees is not permitted by law, regulation or contract or would result in adverse tax consequences. The Senior Secured Credit

- 96 -


Facilities are subject to customary covenants relating to financial ratios and restrictions on certain types of transactions, including restricting the Company's ability to incur additional indebtedness, acquire and dispose of assets, make investments, pay dividends, or engage in mergers and acquisitions. The Company is required to maintain a ratio of consolidated funded indebtedness minus unrestricted cash and cash equivalents (in the aggregate not to exceed $50 million and to include not more than $25 million of foreign unrestricted cash and cash equivalents) to consolidated EBITDA for the most recent four fiscal quarter period not to exceed 4.00:1.00; provided that the Company shall be permitted to increase the ratio to 4.50:1.00 in connection with any permitted acquisition or any other acquisition consented to by the Administrative Agent and the Required Lenders (as defined in the Senior Secured Credit Agreement) with total cash consideration in excess of $25 million.  Such increase shall be applicable for the fiscal quarter in which such acquisition is consummated and the three consecutive test periods thereafter.  The Company is also required to maintain a ratio of consolidated EBITDA to consolidated interest expense, in each case for the most recent four fiscal quarter period, of not less than 3.00:1.00. The Company was in compliance with all financial covenants as of December 31, 2018.

Borrowings under the Senior Secured Credit Facilities were utilized to repay and extinguish our obligations under the 2014 Senior Secured Credit Facilities, as defined in Note 8 of the 2017 Annual Report on Form 10-K. In accordance with accounting guidance governing such transactions, upon closing the 2014 Senior Secured Credit Facility and commencement of the Senior Secured Credit Facilities, the Company recognized a loss on extinguishment of debt totaling $10.7 million, of which $10.2 million related to unamortized loan origination fees from the credit agreement for our 2014 Senior Secured Credit Facilities and $0.5 million related to third party fees incurred during the fourth quarter of 2016.  

 

9. COMMITMENTS, CONTINGENCIES, AND GUARANTEES

Lease Obligations

The Company has payment obligations under non-cancellable operating leases, primarily for office space and furniture and fixtures to support its global operations. These leases often contain customary scheduled rent increases or escalation clauses and renewal options. Rent expense is recorded on a straight line basis. As of December 31, 2018, minimum future lease payments required under these leases are as follows (in thousands):

 

 

 

 

 

 

 

Non-Related

 

 

Total

 

 

 

Related Party

 

 

Parties Operating

 

 

Operating

 

 

 

Operating Leases

 

 

Leases

 

 

Leases

 

2019

 

$

1,987

 

 

$

6,186

 

 

$

8,173

 

2020

 

 

6,843

 

 

 

6,617

 

 

 

13,460

 

2021

 

 

6,964

 

 

 

5,873

 

 

 

12,837

 

2022

 

 

6,757

 

 

 

3,694

 

 

 

10,451

 

2023

 

 

5,229

 

 

 

3,257

 

 

 

8,486

 

Thereafter

 

 

103,870

 

 

 

5,752

 

 

 

109,622

 

Total minimum lease payments

 

$

131,650

 

 

$

31,379

 

 

$

163,029

 

 

The related party operating leases are for two of the Company’s several buildings within its corporate headquarters. The non-related party operating leases are for the Company’s remaining leases throughout the world consisting primarily of office space, fixtures and vehicles.

Rental expense under operating leases totaled $9.2 million, $7.9 million and $6.7 million for the years ended December 31, 2018, 2017 and 2016, respectively, and is allocated between Total direct costs, and Selling, general and administrative in the consolidated statements of operations.

 

- 97 -


Deemed Landlord Liabilities

As of December 31, 2018, minimum annual payments required in conjunction with the Deemed landlord liabilities are as follows (in thousands):

 

 

 

Related Party

 

 

 

 

 

 

Total

 

 

 

Minimum Lease

 

 

Less:

 

 

Principal

 

 

 

Payments

 

 

Interest

 

 

Amounts Due

 

2019

 

$

3,918

 

 

$

1,818

 

 

$

2,100

 

2020

 

 

3,988

 

 

 

1,662

 

 

 

2,326

 

2021

 

 

4,039

 

 

 

1,490

 

 

 

2,549

 

2022

 

 

4,092

 

 

 

1,301

 

 

 

2,791

 

2023

 

 

4,145

 

 

 

1,095

 

 

 

3,050

 

Thereafter

 

 

15,697

 

 

 

1,929

 

 

 

13,768

 

Total

 

$

35,879

 

 

$

9,295

 

 

$

26,584

 

Legal Proceedings

Medpace periodically becomes involved in various claims and lawsuits that are incidental to its business. Management believes, after consultation with counsel, that no matters currently pending would, in the event of an adverse outcome, have a material impact on the Company’s consolidated balance sheets, statements of operations, or cash flows for the years ended December 31, 2018, 2017 and 2016.

Purchase Commitments

 

The Company has several minimum purchase commitments for project related supplies totaling $5.2 million. In return for the commitment, Medpace receives preferential pricing. The commitments expire at various times through 2023.

 

 

10. SHAREHOLDERS’ EQUITY

Stock-Based Compensation

2016 Incentive Award Plan

On August 11, 2016 in connection with the Company's IPO, the Board approved the formation of the 2016 Incentive Award Plan (the “2016 Plan”), which replaced our 2014 Equity Incentive Plan (the “2014 Plan”). The 2016 Plan provides for long-term equity incentive compensation for key employees, officers and non-employee directors. A variety of discretionary awards (collectively, the “Awards”) for employees and non-employee directors are authorized under the 2016 Plan, including vested shares, stock options, stock appreciation rights (“SARs”), restricted stock awards (“RSAs”), restricted stock units (“RSUs”), or other cash based or stock dividend equivalent awards, which are all equity-classified instruments under the 2016 Plan. The number of shares registered and available for grant under the 2016 Plan is 6,000,000. The vesting of such awards may be conditioned upon either a specified period of time or the attainment of specific performance goals as determined by the administrator of the 2016 Plan. The option price and term are also subject to determination by the administrator with respect to each grant. Option prices are generally expected to be set at the market price of the Company’s common stock at the date of grant and option terms are not expected to exceed ten years.

The Company granted 850,700 awards to employees under the 2016 Plan during the year ended December 31, 2018, consisting of 550,500 stock option awards and 300,200 restricted stock units (“RSU”), all vesting after four years. The Company granted an additional 33,801 stock option awards to non-employee directors under the 2016 Incentive Award Plan, during the year ended December 31, 2018. These awards will vest on the earlier of (a) the day immediately preceding the date of the first annual meeting following the date of grant and (b) the first anniversary of the date of grant, subject to the non-employee director continuing in service through the applicable vesting date.   

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The Company granted 968,550 awards to employees under the 2016 Plan during the year ended December 31, 2017, consisting of 797,550 stock option awards, 118,000 restricted stock awards (“RSA”) and 38,000 restricted stock units (“RSU”), all vesting after four years. The Company granted 15,000 stock option awards, vesting equally on the second, third and fourth anniversary of the grant date over four years. Additionally, the Company granted 41,346 stock option awards, vesting over one year, to non-employee directors under the 2016 Incentive Award Plan, during the year ended December 31, 2017.    

The Company granted 648,180 stock options under the 2016 Plan during the year ended December 31, 2016, consisting of 626,650 stock options vesting after four years and 21,530 stock options with various vesting schedules, but all of which vest within a calendar year of the respective grant date. The 2016 Plan has reserved 6,000,000 shares for issuance of RSAs, RSUs or stock options, of which approximately 3.8 million awards were available for future grants as of December 31, 2018.

The 2016 Plan expires in 2026, except for awards then outstanding, and is administered by the Board. All Awards granted at the IPO or thereafter were or will be issued under the 2016 Plan.

The company satisfies stock option exercises and vested stock awards with newly issued shares. Shares available for future stock compensation grants totaled 3.8 million and 4.3 million at December 31, 2018 and 2017.

2014 Equity Incentive Plan

The 2014 Plan for employees and directors provided the issuance of vested shares, stock options, RSAs and RSUs in Medpace Holdings, Inc.’s common stock. The awards were granted to key employees as additional compensation for services rendered and as a means of retention over the vesting period, typically three to four years. RSAs awarded under the 2014 Plan were subject to automatic forfeiture upon departure until vested and entitle the shareholder to all rights of common stock ownership except that they may not be sold, transferred, pledged or otherwise disposed of during the restriction period, except as noted in the following paragraph. The 2014 Plan allowed for the issuance of non-qualified stock options to employees, officers, and directors under this plan (collectively, “the Participants”). Under the 2014 Plan, options could be granted with an exercise price equal to or greater than the fair value of common stock at the grant date as determined by the Board of Directors. The stock options, if unexercised, expired seven years from the date of grant. The Company granted 45,932 Awards under the 2014 Plan, consisting of 34,821 stock options vesting equally over four years and 11,111 fully vested shares, during the year ended December 31, 2016.

As a condition to exercising stock options and acceptance of certain restricted shares, employees must have executed a Contribution and Subscription Agreement (the “Subscription Agreement”) that provided for the exchange of the shares issued for incentive units (the “Incentive Units”) in Medpace Investors upon the occurrence of certain events.  The Incentive Units were tied directly to common stock ownership in Medpace Holdings, Inc. and entitled the Incentive Unit holder to participate in the risks and rewards of owning the Company’s stock through ownership in Medpace Investors. The awards containing this condition were liability-classified instruments as they were inevitably settled in the equity of a non-consolidated related party. Restricted share awards excluding the requirement to execute a Contribution and Subscription Agreement and settlement in common shares of Medpace Holdings, Inc. were equity-classified instruments.

At the grant date for RSAs that were liability-classified, restricted shares were legally issued and exchanged for Medpace Investors Incentive Units on behalf of the employee.  If the RSAs were not yet vested and an employee left the Company’s employment, the restricted shares of Medpace Holdings, Inc. reverted back to the Company and were available for re-issuance under the 2014 Plan.  Upon the vesting of RSAs and RSUs and upon the exercise of stock options, the stock-based compensation liability was settled by exchanging the Company’s stock for Medpace Investors Incentive Units.  If an employee left the Company’s employment after they vested in the Awards and the exchange for Incentive Units was made, Medpace Investors may exercise a call option to repurchase an employee’s Incentive Units at a price determined by the manager and majority unit holder of Medpace Investors, who is also the chief executive officer of Medpace.  If Medpace Investors exercised the call right, it could do so up to the later of twelve months following the employee’s departure date or six months following the determination that the former employee was directly or indirectly engaged in competitive business activities.  

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Restricted Awards Modification

On December 17, 2015, the Board of Directors approved a resolution to accelerate the vesting period for all issued, outstanding and unvested RSAs and RSUs to vest on December 31, 2015, so long as the recipient of each restricted share or unit was in good standing, had not provided notice of resignation and continued to be employed by the Company as of December 31, 2015. In total, 688,599 unvested restricted awards held by 158 current employees were modified resulting in settlement of 688,599 shares.

According to the authoritative guidance for stock-based compensation, under these circumstances a company should recognize additional stock-based compensation expense in the amount of the incremental fair value of the modified award. Because the restricted awards that were modified were liability-classified, the awards were at fair value at the time of the modification and no incremental cost was recognized. While there was no incremental cost related to fair value of the awards, $5.7 million of stock-based compensation expense was recorded in 2015 related to previously unrecognized stock-based compensation cost for awards expected to vest in 2016, 2017 and 2018.  

Option Awards Modification

As a result of the Company’s IPO, a condition of all outstanding stock options issued before August 10, 2016 under the 2014 Plan that previously required the exchange of the shares issued for incentive units in the equity of a non-consolidated related party was dissolved. All future exercises of options issued pursuant to the 2014 Plan will now settle in shares of the Company. As a result of the modification in the settlement condition, the options will now be equity-classified instruments and changes in the fair value of the stock compensation liability that occur during the requisite service period are no longer recognized. According to the authoritative guidance for stock-based compensation, at modification the Company should recognize additional stock-based compensation expense in the amount of the incremental fair value of the modified award. As a result, the Company recognized $3.1 million of incremental stock-based compensation expense during the year ended December 31, 2016. In addition, the $10.5 million stock-based compensation liability associated with the modified stock options was reclassified to additional paid-in capital as a result of the change to equity classification. There is no stock-based compensation liability for the years ended December 31, 2018 and 2017. 

Equity Awards

Valuation Assumptions

The Company determines the fair value of stock options using the Black-Scholes-Merten option pricing model (the “BSM Model”). The BSM Model is primarily affected by the fair value of the Company’s common stock (see restricted share valuation discussion below), the expected holding period for the option, expected stock price volatility over the term of the awards, the risk-free interest rate, and expected dividends.

The following table sets forth the key weighted-average assumptions used in the BSM Model to calculate the fair value of options:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Expected holding period - years

 

5.4

 

 

5.4

 

 

3.6

 

Expected volatility

 

27.0%

 

 

28.0%

 

 

30.2%

 

Risk-free interest rate

 

2.8%

 

 

2.0%

 

 

1.0%

 

Expected dividend yield

 

 

0.0%

 

 

 

0.0%

 

 

 

0.0%

 

 

The assumptions used in the table above reflect both grant date inputs to arrive at the grant date fair values for stock options subject to equity-classified stock compensation accounting and reflect a fair value calculation for stock options outstanding in the period subject to liability-classified stock compensation accounting.  Subsequent to August 10, 2016, all outstanding stock based awards are subject to equity classification through either modifications of the award terms and conditions that occurred during the year ended December 31, 2016, or based on terms and conditions applicable as of the grant date.

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The expected holding period represents the period of time the grants are expected to be outstanding. The Company uses the simplified method, as prescribed by accounting guidance governing such awards, to calculate the expected holding period for options granted to employees as we do not have sufficient historical evidence data to provide a reasonable basis upon which to estimate the expected holding period. For options valued by the Company for the years ended December 31, 2018, 2017 and 2016, the expected holding period is based on an average between the midpoint of the vesting date and the expiration date of the options.

The Company estimates expected volatility primarily by using the historical volatility of a publicly traded peer group that operates in the clinical research and development industry. The Company does not have adequate history to calculate its own historical or implied volatility and believes the Company’s expected volatility will approximate the historical experience of the peer group.

The risk-free interest rate is based on the yield on U.S. Treasury obligations with remaining durations equal to the expected holding period of the options. The expected dividend yield is assumed to be zero based on recent and anticipated dividend activity.

Subsequent to the IPO, the fair value of common stock is based upon the market price of the Company’s common stock on the date of grant as listed on the NASDAQ.  Due to the absence of an active market for the Company’s common stock prior to the IPO, the Company determined the fair value of restricted shares by obtaining an independent valuation of the fair value of the Company’s equity, applying a discount for lack of marketability, and then calculating the implied share price. The fair value of the Company was estimated primarily using an income approach which is based on assumptions and estimates made by management and, secondarily, using other market-related factors in current industry trends as well as observed transaction values. In determining the estimated future cash flows used in the income approach, the Company developed and applied certain estimates and judgments, including current and projected future levels of income based on management’s plans, business trends, prospects and market and economic conditions, including market-participant considerations. Significant assumptions utilized in the income approach were based on company specific information and projections, which were not observable in the market and are thus considered Level 3 measurements by authoritative guidance. The discount for lack of marketability (the “Marketability Discount”) was applied to reflect what a market participant would consider in relation to the post-vesting restrictions imposed regarding the inability to sell, transfer, or pledge the shares during the restriction period. The Marketability Discount was estimated by using the BSM Model to calculate the cost of a theoretical put option to hedge the fluctuation in value of the investment between the valuation date and an anticipated liquidity date.

The following table summarizes the grant date fair values of stock options and restricted shares issued during the period as well as the allocation of stock-based compensation expense to Total direct costs, and Selling, general and administrative reported in the consolidated statements of operations:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Weighted average, grant date fair value

 

 

 

 

 

 

 

 

 

 

 

 

Stock options

 

$

11.51

 

 

$

8.54

 

 

$

6.91

 

Restricted shares (RSAs and RSUs)

 

$

49.38

 

 

$

31.90

 

 

$

15.08

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

   allocated to:

 

 

 

 

 

 

 

 

 

 

 

 

Total direct costs

 

$

4,132

 

 

$

2,128

 

 

$

5,555

 

Selling, general, and administrative

 

 

2,367

 

 

 

2,335

 

 

 

4,260

 

Total stock-based compensation expense

 

$

6,499

 

 

$

4,463

 

 

$

9,815

 

 

- 101 -


Award Activity

The following table sets forth the Company’s stock option activity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

Weighted Average

 

 

 

Options

 

 

Exercise Price

 

 

Options

 

 

Exercise Price

 

 

Shares

 

 

Exercise Price

 

Outstanding - beginning of Period

 

 

2,782,868

 

 

$

20.73

 

 

 

2,350,166

 

 

$

17.57

 

 

 

1,794,709

 

 

$

15.42

 

Granted

 

 

584,301

 

 

$

37.72

 

 

 

853,896

 

 

$

28.67

 

 

 

683,001

 

 

$

22.80

 

Exercised

 

 

(169,771

)

 

$

14.98

 

 

 

(116,787

)

 

$

15.52

 

 

 

(36,980

)

 

$

14.50

 

Forfeited/Expired

 

 

(252,358

)

 

$

23.69

 

 

 

(304,407

)

 

$

20.55

 

 

 

(90,564

)

 

$

15.85

 

Outstanding - end of period

 

 

2,945,040

 

 

$

24.18

 

 

 

2,782,868

 

 

$

20.73

 

 

 

2,350,166

 

 

$

17.57

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercisable - end of period

 

 

1,096,116

 

 

$

16.01

 

 

 

917,592

 

 

$

15.40

 

 

 

647,343

 

 

$

15.22

 

 

The following table sets forth the Company’s Restricted Share activity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

 

 

Shares/Units

 

 

Shares/Units

 

 

Shares/Units

 

Outstanding and unvested - beginning of

   period

 

 

183,629

 

 

 

59,258

 

 

 

90,697

 

Granted

 

 

300,200

 

 

 

156,000

 

 

 

11,111

 

Vested

 

 

(29,629

)

 

 

(29,629

)

 

 

(41,069

)

Forfeited

 

 

(33,000

)

 

 

(2,000

)

 

 

(1,481

)

Outstanding and unvested - end of period

 

 

421,200

 

 

 

183,629

 

 

 

59,258

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cumulative vested shares - end of period

 

 

1,913,916

 

 

 

1,884,287

 

 

 

1,854,658

 

 

During the year ended December 31, 2016, 11,111 Restricted Shares were granted and immediately vested upon issuance (the “Vested Shares”).

The following table summarizes information about stock options expected to vest, stock options exercisable, and unvested restricted share awards expected to vest at December 31, 2018:

 

 

 

Weighted Average

 

 

 

 

 

 

 

 

 

 

Weighted Average

 

 

 

Exercise

 

 

Stock

 

 

Restricted

 

 

Remaining

 

 

 

Price

 

 

Options

 

 

Shares

 

 

Life (Years)

 

December 31, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number of stock options expected

   to vest

 

$

24.18

 

 

 

2,945,040

 

 

 

-

 

 

 

4.4

 

Number of Restricted Shares expected

   to vest

 

 

 

 

 

 

-

 

 

 

421,200

 

 

 

 

 

Total expected to vest - December 31, 2018

 

 

 

 

 

 

2,945,040

 

 

 

421,200

 

 

 

 

 

Total stock options exercisable -

   December 31, 2018

 

$

16.01

 

 

 

1,096,116

 

 

 

 

 

 

 

3.0

 

Unrecognized compensation cost -

   December 31, 2018 (in thousands)

 

 

 

 

 

$

10,021

 

 

$

15,734

 

 

 

 

 

Weighted average years over which

   unrecognized compensation cost will be

   recognized

 

 

 

 

 

 

2.7

 

 

 

3.5

 

 

 

 

 

 

- 102 -


The following table sets forth the aggregate intrinsic value of stock options exercised, the fair values of awards vested, and share based liabilities settled during the respective periods (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Total intrinsic value of stock options

   exercised

 

$

5,326

 

 

$

1,619

 

 

$

403

 

Total grant-date fair value of stock

   options vested

 

$

1,417

 

 

$

1,317

 

 

$

1,384

 

Total grant-date fair value of

   restricted shares vested

 

$

447

 

 

$

447

 

 

$

614

 

Total settlement date fair value of

   restricted shares vested

 

$

1,568

 

 

$

1,074

 

 

$

1,236

 

Total share-based liabilities settled

 

$

-

 

 

$

-

 

 

$

76

 

The actual tax benefits recognized related to stock-based compensation totaled $1.0 million, $0.5 million and $1.0 million for the years ended December 31, 2018, 2017 and 2016, respectively.

11. EMPLOYEE BENEFIT PLANS

The Company provides a 401(k) plan that covers substantially all U.S. employees. Participants can elect to contribute up to 50% of their eligible earnings on a pre-tax basis, subject to Internal Revenue Service annual limitations.

The U.S.-based plan offers a year-end employer matching contribution, requiring the participant to be an employee at year-end to qualify for the match. Participants with one year or more of service are eligible for the matching contribution. Participants fully vest in the employer contributions after three years of service. The employer contribution represents a percentage of a participant’s eligible compensation. The Company’s 401(k) Plan costs were $2.7 million, $2.3 million and $2.0 million during the years ended December 31, 2018, 2017 and 2016, respectively, and were allocated between Total direct costs, and Selling, general and administrative in the consolidated statements of operations.

The Company has various defined contribution arrangements for eligible employees of non-U.S. entities. These defined contribution arrangements provide employees with retirement savings and life insurance benefits. The Company incurred expenses related to these arrangements of $1.0 million, $0.9 million and $0.7 million in the years ended December 31, 2018, 2017 and 2016, respectively, and were allocated between Total direct costs, and Selling, general and administrative in the consolidated statements of operations.

The Company is also required to pay certain minimum statutory post-employment benefits. The Company recognizes a liability and the associated expense for these benefits when it is probable that employees are entitled to the benefit.

12. INCOME TAXES

US Tax Reform

The “Tax Cuts and Jobs Act” (TCJA) was enacted on December 22, 2017 and it significantly reforms the Internal Revenue Code of 1986, as amended. The TCJA, among other things, includes a reduction in the U.S. federal tax rate from 35% to 21%, allows for the expensing of capital expenditures, requires companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax deferred, creates new taxes on certain foreign sourced earnings and puts into effect the migration from a “worldwide” system of taxation to a territorial system.  

- 103 -


The Company recognized the income tax effects of the “Tax Cuts and Jobs Act” (TCJA) in its audited consolidated financial statements on our 2017 Annual Report on Form 10-K in accordance with Staff Accounting Bulletin No. 118, which provides Securities and Exchange Commission staff guidance for the application of ASC Topic 740, Income Taxes, in the reporting period in which the TCJA was signed into law. The guidance also provides for a measurement period of up to one year from the enactment date for the Company to complete the accounting for the U.S. tax law changes. As such, the Company’s 2017 financial results reflected the provisional estimate of the income tax effects of the TCJA.

The Company completed its analysis of the TCJA in 2018 and adjusted the 2017 provisional estimates to the final amounts.  A summary of the provisional and final amounts is included below:  

 

Transition tax on unrepatriated foreign earnings: The Company originally estimated a transition tax expense of $0.6 million and the final transition tax liability is $0.7 million. The adjustment unfavorably impacted the effective tax rate by approximately 0.1%.  

 

Reduction of U.S. Federal Corporate Tax Rate: The Company originally estimated a provisional tax benefit of $3.4 million related to the revaluation of deferred tax assets and liabilities. The deferred tax assets/liabilities as of December 31, 2017 were adjusted to match the balances per the 2017 U.S. corporate income tax return. The revised deferred balance was then adjusted from a 35% tax rate to a 21% tax rate. This resulted in a final tax benefit of approximately $3.6 million. The adjustment favorably impacted the effective tax rate by approximately 0.2%.

 

 

Indefinite reinvestment assertion: Prior to the passage of the TCJA, the Company asserted that all of the undistributed foreign earnings of its foreign subsidiaries were considered indefinitely reinvested and accordingly, no deferred taxes were provided. Beginning in 2018, the TCJA provides a 100% deduction for dividends received from 10-percent owned foreign corporations by U.S. corporate shareholders, subject to a one-year holding period. Although dividend income is now exempt from U.S. federal tax in the hands of the U.S. corporate shareholders, companies must still apply the guidance of ASC 740-30-25-18 to account for the tax consequences of outside basis differences and other tax impacts of their investments in non-U.S. subsidiaries. The Company has accrued the Transition Tax on the deemed repatriated earnings that were previously indefinitely reinvested. The Company has not recorded deferred foreign withholding taxes on approximately $21.1 million of pre-2018 earnings which are considered permanently reinvested.

 

Global intangible low taxed income (GILTI): The TCJA creates a new requirement that certain income (i.e., GILTI) earned by foreign subsidiaries must be included currently in the gross income of the U.S. shareholder. The Company has made an accounting policy election to treat GILTI taxes as a current period expense.

The Company files income tax returns for U.S. federal and various U.S. states, as well as various foreign jurisdictions. The liabilities for unrecognized tax benefits are carried in Other long-term liabilities on the consolidated balance sheets because the payment of cash is not anticipated within one year of the balance sheet date.

The components of income before income taxes consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Domestic

 

$

88,014

 

 

$

52,986

 

 

$

18,016

 

Foreign jurisdictions

 

$

5,937

 

 

$

3,959

 

 

$

3,941

 

Income before income taxes

 

$

93,951

 

 

$

56,945

 

 

$

21,957

 

 

- 104 -


Income tax provision consisted of the following (in thousands):

 

 

 

Current

 

Deferred

 

 

Total

 

Year ended December 31, 2018

 

 

 

 

 

 

 

 

 

 

 

U.S. Federal

 

$

13,372

 

$

4,172

 

 

$

17,544

 

U.S. state and local

 

 

1,912

 

 

(116

)

 

 

1,796

 

Foreign jurisdictions

 

 

1,408

 

 

18

 

 

 

1,426

 

 

 

$

16,692

 

$

4,074

 

 

$

20,766

 

 

 

 

 

 

 

 

 

 

 

 

 

Year ended December 31, 2017

 

 

 

 

 

 

 

 

 

 

 

U.S. Federal

 

$

10,953

 

$

3,466

 

 

$

14,419

 

U.S. state and local

 

 

2,032

 

 

51

 

 

 

2,083

 

Foreign jurisdictions

 

 

1,576

 

 

(255

)

 

 

1,321

 

 

 

$

14,561

 

$

3,262

 

 

$

17,823

 

 

 

 

 

 

 

 

 

 

 

 

 

Year ended December 31, 2016

 

 

 

 

 

 

 

 

 

 

 

U.S. Federal

 

$

15,105

 

$

(8,784

)

 

$

6,321

 

U.S. state and local

 

 

1,636

 

 

(524

)

 

 

1,112

 

Foreign jurisdictions

 

 

710

 

 

389

 

 

 

1,099

 

 

 

$

17,451

 

$

(8,919

)

 

$

8,532

 

 

The difference between the statutory rate for federal income tax and the effective income tax rate was as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Income tax expense calculated

   at the federal statutory rate

 

$

19,730

 

 

 

21.0

%

 

$

19,931

 

 

 

35.0

%

 

$

7,685

 

 

 

35.0

%

Effect of:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

State and local taxes, net

   of federal benefit

 

 

1,978

 

 

 

2.1

 

 

 

1,606

 

 

 

2.8

 

 

 

912

 

 

 

4.2

 

Tax on foreign earnings,

   net of tax credits and

   deductions

 

 

172

 

 

 

0.2

 

 

 

(69

)

 

 

(0.1

)

 

 

(26

)

 

 

(0.1

)

Tax reform adjustment

 

 

(195

)

 

 

(0.2

)

 

 

(3,418

)

 

 

(6.0

)

 

 

-

 

 

 

-

 

Write off of Deferred Tax Assets

 

 

509

 

 

 

0.6

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Deferred credit

 

 

(802

)

 

 

(0.9

)

 

 

(1,053

)

 

 

(1.9

)

 

 

-

 

 

 

-

 

Change in valuation

   allowance

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Permanent items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based awards

 

 

(651

)

 

 

(0.7

)

 

 

(179

)

 

 

(0.3

)

 

 

(534

)

 

 

(2.4

)

Tax reform adjustment

 

 

126

 

 

 

0.1

 

 

 

574

 

 

 

1.0

 

 

 

-

 

 

 

-

 

Other

 

 

687

 

 

 

0.7

 

 

 

483

 

 

 

0.9

 

 

 

174

 

 

 

0.8

 

State/Local tax credits

 

 

(1,253

)

 

 

(1.3

)

 

 

(1,187

)

 

 

(2.1

)

 

 

(1,049

)

 

 

(4.8

)

Foreign tax credits

 

 

(727

)

 

 

(0.8

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Change in liability for

   uncertain tax positions

 

 

1,102

 

 

 

1.2

 

 

 

1,141

 

 

 

2.0

 

 

 

1,212

 

 

 

5.5

 

Other

 

 

90

 

 

 

0.1

 

 

 

(6

)

 

 

(0.0

)

 

 

158

 

 

 

0.7

 

 

 

$

20,766

 

 

 

22.1

%

 

$

17,823

 

 

 

31.3

%

 

$

8,532

 

 

 

38.9

%

 

- 105 -


Components of the Company’s net deferred tax asset (liability) included in the consolidated balance sheets consisted of the following at December 31 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

2018

 

 

2017

 

Deferred tax assets:

 

 

 

 

 

 

 

 

Accrued liabilities

 

$

18,670

 

 

$

17,563

 

Depreciation and amortization

 

 

872

 

 

 

980

 

Foreign operating loss carryforward

 

 

248

 

 

 

246

 

U.S. federal tax credits and carryforward

 

 

-

 

 

 

8,152

 

U.S. state and local tax credits and

   carryforward

 

 

223

 

 

 

1,799

 

Other

 

 

41

 

 

 

667

 

Valuation allowance

 

 

(169

)

 

 

(2,394

)

Total deferred tax assets

 

 

19,885

 

 

 

27,013

 

 

 

 

 

 

 

 

 

 

Deferred tax liabilities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

(18,803

)

 

 

(20,117

)

Prepaid expenses

 

 

(550

)

 

 

(572

)

Other

 

 

(258

)

 

 

(541

)

Total deferred tax liabilities

 

 

(19,611

)

 

 

(21,230

)

Net deferred tax asset

 

$

274

 

 

$

5,783

 

 

 

U.S. state and local tax credits noted above will expire in 2023 if not utilized.

The Company has foreign operating loss carryforwards for which a deferred tax asset of $0.2 million has been established. The Company has a valuation allowance of $0.2 million against this deferred tax asset based upon its assessment that it is more likely than not that this amount will not be realized. The ultimate realization of this tax benefit is dependent upon the generation of sufficient operating income in the respective tax jurisdictions. Approximately 59% of the foreign net operating loss carryforwards can be utilized over an indefinite period whereas the remainder will expire at various times from 2020 to 2027 if not utilized.

 

In May 2017, the Company acquired Nephrogenex which included deferred tax assets of $22.2 million, consisting of tax effected net operating losses in the amount of $13.5 million, tax effected capitalized research and development expenses of $8.5 million and tax effected federal tax credits of $0.2 million, and deferred tax liabilities of $0.1 million. See Note 2 for further description of the asset acquisition that occurred in the second quarter of 2017. In 2018, the Company disposed of approximately $7.4 million in deferred tax assets and reduced the Deferred credit by approximately $6.9 million (net increase in tax expense of approximately $0.5 million) as a result of an IRC Section 382 ownership shift that occurred as a result of Cinven’s sales of the Company’s securities. The ownership shift resulted in a limitation in the ability to utilize the acquired tax attributes and resulted in the described asset write-off and reduction of the Deferred credit.

- 106 -


Annual activity related to the Company’s valuation allowance is as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Beginning Balance

 

$

2,394

 

 

$

987

 

 

$

1,021

 

Additions charged to expense

 

 

-

 

 

 

-

 

 

 

-

 

Additions due to asset acquisition

 

 

-

 

 

 

2,033

 

 

 

-

 

Reductions from utilization, reassessments and

   expirations

 

 

(2,225

)

 

 

3

 

 

 

(34

)

Remeasurement due to effect of tax reform

 

 

-

 

 

 

(629

)

 

 

-

 

Ending Balance

 

$

169

 

 

$

2,394

 

 

$

987

 

 

A reconciliation of the beginning and ending balances of the total amounts of gross unrecognized tax benefits is as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Beginning Balance

 

$

6,890

 

 

$

5,698

 

 

$

2,604

 

Increases in tax positions for prior years

 

 

-

 

 

 

5

 

 

 

-

 

Decreases in tax positions for prior years

 

 

(579

)

 

 

-

 

 

 

(196

)

Increases in tax positions for current year

 

 

2,214

 

 

 

1,187

 

 

 

3,365

 

Lapse in statute of limitations

 

 

-

 

 

 

-

 

 

 

(75

)

Ending Balance

 

$

8,525

 

 

$

6,890

 

 

$

5,698

 

 

Interest and penalties associated with uncertain tax positions are recognized as components of Income tax provision in the consolidated statements of operations. There was no material change to tax-related interest and penalties during the years ended December 31, 2018, 2017 and 2016. As of December 31, 2018 and 2017, respectively, the Company has a liability for interest and penalties of $1.0 million and $1.4 million that is associated with related tax liabilities of $7.2 million and $5.9 million for uncertain tax positions.

The Company operates in various foreign, state and local jurisdictions. The number of tax years for which the statute of limitations remains open for foreign, state and local jurisdictions varies by jurisdiction and is approximately four years (2014 through 2018). For federal tax purposes, the Company’s open tax years are 2015 through 2018.

13. MISCELLANEOUS INCOME (EXPENSE), NET

Miscellaneous income (expense), net consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

Net gain (loss) on foreign-currency transactions

 

$

386

 

 

$

(1,004

)

 

$

(660

)

Other income

 

 

674

 

 

 

650

 

 

 

237

 

Miscellaneous income (expense), net

 

$

1,060

 

 

$

(354

)

 

$

(423

)

 

14. RELATED PARTY TRANSACTIONS

Employee Loans

The Company periodically extends short term loans or advances to employees, typically upon commencement of employment.  Total receivables as a result of these employee advances of $0.2 million existed at December 31, 2018

- 107 -


and 2017, respectively, and are included in the Prepaid expenses and other current assets and Other assets line items of the consolidated balance sheets, respectively, depending on the contractual repayment date.

Management Fees

In conjunction with the IPO, the Advisory Services Agreement with Cinven Capital Management (V) General Partner Limited (“Cinven”) expired. Subsequent to the IPO, the Company paid fees for director services provided by Cinven employees that were members of the Company’s Board of Directors and any related committees. The director fees were paid directly to Cinven in accordance with the Company’s non-employee director compensation policy. During the third quarter of 2018, Cinven sold its remaining shares of the Company’s common stock and all three members of the Company’s Board affiliated with Cinven subsequently resigned. During the year ended December 31, 2016, the Company incurred management fees to Cinven of $0.2 million. During the years ended December 31, 2018 and 2017, the Company incurred director fees of $0.1 million, respectively. In connection with these fees, Cinven incurred related travel expenses of less than $0.1 million, $0.1 million and $0.1 million, respectively, during the years ended December 31, 2018, 2017 and 2016.  

Service Agreements

Coherus BioSciences, Inc. (“Coherus”) and MX II Associates, LLC (“MXII”)

The chief executive officer of the Company was a member of Coherus BioSciences, Inc.’s (“Coherus”) board of directors until his resignation in the first quarter of 2018. Coherus is no longer considered a related party as of the first quarter of 2018. During 2011 a related party of the Company in which the Company’s chief executive officer is the managing member, MXII, made an investment in Coherus. In early 2012 the Company made a $2.5 million investment in Coherus. Concurrent with the initial investment, MXII secured the exclusive rights for Medpace to perform Phase I through Phase III clinical trial work for certain Coherus’ “bio-similar” drug compounds executed through a MSA. The agreement provides for a minimum fee commitment for clinical trial services and is cancelable without cause by either party upon 30 days prior notice. During the years ended December 31, 2017 and 2016, the Company recognized service revenue of $8.0 million and $22.3 million from Coherus in the Company’s consolidated statements of operations, respectively. In addition, the company recognized Reimbursed out-of-pocket revenue and Reimbursed out-of-pocket expenses with Coherus in the consolidated statements of operations of $1.3 million and $5.1 million during the years ended December 31, 2017 and 2016, respectively. As of December 31, 2017, the Company had Accounts receivable and unbilled, net from Coherus of $0.3 million recorded in the consolidated balance sheets. In addition, the Company had Advanced billings of $1.5 million and Pre-funded study costs of $1.0 million with Coherus recorded in the consolidated balance sheets at December 31, 2017.

Xenon Pharmaceuticals, Inc. (“Xenon”)

Certain executives and employees of the Company, including the chief executive officer, have held equity investments in Xenon, a clinical-stage biopharmaceutical company. In addition, a Medpace employee was a director of Xenon until May 2015. During the second quarter of 2017, the chief executive officer sold his entire equity position held in Xenon. Xenon is no longer considered to be a related party subsequent to this sale. During July 2015 the Company and Xenon entered into an amended MSA agreement for the Company to provide clinical trial related services. The Company recognized service revenue from Xenon of $0.6 million and $1.3 million during the six months ended June 30, 2017 and the year ended December 31, 2016, respectively, in the Company’s consolidated statements of operations. In addition, the Company recognized Reimbursed out-of-pocket revenue and Reimbursed out-of-pocket expenses with Xenon in the consolidated statements of operations of $0.1 million and $0.2 million during the six months ended June 30, 2017 and the year ended December 31, 2016, respectively.

Cymabay Therapeutics, Inc. (“Cymabay”)

Cymabay is a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, including serious rare and orphan disorders. During the first quarter of 2016, it was announced that a Medpace employee would join Cymabay’s board of directors. The Company and Cymabay entered into a MSA dated October 21, 2016. Subsequently, the Company and Cymabay have entered into several task orders for the Company to perform clinical trial related services. The Company recognized total revenue from Cymabay of $10.8 million during the year ended December 31, 2018 in the Company’s consolidated statements of operations. The Company recognized service revenue from Cymabay of $0.6 million and $0.3 million during the years ended December 31, 2017 and 2016, respectively, in the Company’s consolidated statements of operations. As of

- 108 -


December 31, 2018 and 2017, the Company had Accounts receivable and unbilled, net from Cymabay of $2.5 million and $0.1 million recorded in the consolidated balance sheets, respectively.

LIB Therapeutics LLC and subsidiaries (“LIB”)

Certain executives and employees of the Company, including the chief executive officer, are members of LIB’s board of managers and/or have equity investments in LIB. The Company entered into a MSA dated November 24, 2015 with LIB, a company that engages in research, development, marketing and commercialization of pharmaceutical drugs. Subsequently, the Company and LIB have entered into several task orders for the Company to perform clinical trial related services. The Company recognized total revenue from LIB of $3.7 million during the year ended December 31, 2018 in the Company’s consolidated statement of operations. The Company recognized service revenue from LIB of $1.4 million and $0.2 million during the years ended December 31, 2017 and 2016 in the Company’s consolidated statements of operations, respectively. As of December 31, 2018 and 2017, the Company had, from LIB, Advanced billings of $0.3 million and $0.2 million in the consolidated balance sheets, respectively. In addition, the Company had Accounts receivable and unbilled, net from LIB of $1.0 million and $0.5 million in the consolidated balance sheets at December 31, 2018 and 2017, respectively.

CinRX Pharma and subsidiaries (“CinRx”)

Certain executives and employees of the Company, including the chief executive officer, are members of CinRx’s board of managers and/or have equity investments in CinRx, a biotech company. The Company and CinRx have entered into several task orders for the Company to perform clinical trial related services. During the year ended December 31, 2018, the Company recognized total revenue from CinRx of $0.5 million in the Company’s consolidated statements of operations. During the year ended December 31, 2017, the Company recognized service revenue from CinRx of $0.4 million in the Company’s consolidated statements of operations. As of December 31, 2018 the Company had Accounts receivable and unbilled, net from CinRx of $0.4 million in the consolidated balance sheets.

The Summit, a Dolce Hotel (“The Summit”)

The Summit Hotel, located on the Medpace campus, is owned by the chief executive officer, and managed by an unrelated hospitality management entity. Medpace incurs travel lodging and meeting expenses at The Summit. During the year ended December 31, 2018, Medpace incurred expenses of $0.4 million at The Summit.

Medpace Investors, LLC

Medpace Investors is a noncontrolling shareholder and related party of Medpace Holdings, Inc. Medpace Investors is owned and managed by employees of the Company. The Company’s chief executive officer is also the manager and majority unit holder of Medpace Investors. The Company acts as a paying agent for Medpace Investors with taxing authorities principally in instances when employee tax payments or remittance of withholdings related to equity compensation are required. During the year ended December 31, 2016, the Company paid $0.8 million to various taxing authorities on behalf of Medpace Investors. During the year ended December 31, 2016, the Company received $0.3 million from Medpace Investors for receivables owed to the Company from Symplmed. Additionally, during the year ended December 31, 2016, the Company paid approximately $0.3 million to Medpace Investors due to the settlement of certain liabilities related to the Merger Agreement between the sellers (led by CCMP) and the buyers (led by Cinven).

 

Purchase of Real Estate Properties

In December 2016, the Company entered into a purchase agreement for four parcels of real estate property that are closely situated to the Medpace campus in Cincinnati, Ohio, from AT Redevelopment Company, LLC, which is wholly-owned by the Company’s chief executive officer. The purchase price of the real estate property was $0.4 million as determined by an independent third party broker's opinion of value. The transaction closed on January 11, 2017.

- 109 -


Leased Real Estate

Headquarters Lease

The Company has entered into operating leases for its corporate headquarters and a storage space facility with an entity that is wholly owned by the Company’s chief executive officer. The Company has evaluated its relationship with the related party and concluded that the related party is not a variable interest entity because the Company has no direct ownership interest or relationship other than the leases. The lease for headquarters is for an initial term of twelve years through November 2022 with a renewal option for one 10-year term at prevailing market rates. The lease for storage space was through June 2016 and was leased on a month to month basis, thereafter. The Company pays rent, taxes, insurance, and maintenance expenses that arise from the use of the properties. Annual base rent for the corporate headquarters is $2.2 million and allows for adjustments to the rental rate annually for increases in the consumer price index. Lease expense recognized for the years ended December 31, 2018, 2017 and 2016 was $2.2 million, $2.1 million and $2.1 million, respectively. The lease expense was allocated between Direct service costs, excluding depreciation and amortization, and Selling, general and administrative in the consolidated statements of operations.

In 2018, Medpace, Inc. entered into a multi-year lease agreement governing future occupancy of additional office space in Cincinnati, Ohio. The lease expires in 2040 and the Company has two 10-year options to extend the term of the lease.

Deemed Assets and Deemed Landlord Liabilities

The Company entered into two multi-year lease agreements governing the occupancy of space of two buildings in Cincinnati, Ohio with an entity that is wholly owned by the Company’s chief executive officer and certain members of his immediate family. In accordance with the accounting guidance related to leases, the Company was deemed in substance to be the owner of the property during the construction phase and at completion. Accordingly, the Company reflected the buildings and related liabilities as deemed assets from landlord building construction in Property and equipment, net, Other current liabilities, and Deemed landlord liabilities, respectively, on the consolidated balance sheets. The Company assumed occupancy in 2012 and the leases expire in 2027 with the Company having one 10-year option to extend the lease term. The deemed assets are being fully depreciated, on a straight line basis, over the 15-year term of the lease. Deemed landlord liabilities are recorded at their net present value when the Company enters into qualifying leases and are reduced as the Company makes periodic lease payments on the properties. Accretion expense is being recorded over the term of the lease as a component of Interest expense, net in the Company’s consolidated statements of operations. The Company paid $3.8 million, $3.8 million and $3.7 million during the years ended December 31, 2018, 2017 and 2016, respectively. The current and long-term portions of the Deemed landlord liability at December 31, 2018 were $2.1 million and $24.5 million, respectively. The current and long-term portions of the Deemed landlord liability at December 31, 2017 were $1.9 million and $26.6 million, respectively. The Company has recognized $14.6 million and $16.3 million, respectively, of deemed assets, net at December 31, 2018 and 2017 in the consolidated balance sheets.

Travel Services

Reynolds Jet Management (“Reynolds”)

The Company incurs expenses for travel services for company executives provided by a private aviation charter company that is owned by the chief executive officer and the senior vice president of operations of the Company (“private aviation charter”). The Company may contract directly with the private aviation charter for the use of its aircraft or indirectly through a third party aircraft management and jet charter company (the “Aircraft Management Company”). The travel services provided are primarily for business purposes, with certain personal travel paid for as part of the executives’ compensation arrangements. The Aircraft Management Company also makes the private aviation charter aircraft available to third parties. The Company incurred travel expenses of $1.3 million, $1.1 million and $1.0 million during the years ended December 31, 2018, 2017 and 2016, respectively. These travel expenses are recorded in Selling, general and administrative in the Company’s consolidated statements of operations. As of December 31, 2018 and 2017, the Company had Accounts payable due to Reynolds of $0.2 million in the consolidated balance sheets, respectively.

- 110 -


15. CASH FLOW STATEMENT – SUPPLEMENTAL INFORMATION

During the year ended December 31, 2017, the Company engaged in the following significant non-cash investing and financing activities:

 

Acquired net assets totaling $0.7 million consisting of net Deferred tax assets of $21.1 million, offset by net Deferred tax liabilities of $0.1 million and Deferred credits of $20.3 million in exchange for Accounts receivable and unbilled, net of $0.6 million and Other assets of $0.1 million.

16. ENTITY WIDE DISCLOSURES

Operations By Geographic Location

The Company conducts operations in North America, Europe, Africa, Asia-Pacific and Latin America through wholly-owned subsidiaries and representative sales offices. The Company attributes revenue to geographical locations based upon the location of the contracting entity. For the years ended December 31, 2018 and 2017, total revenue and service revenue attributable to the U.S. represented approximately 97% and 98%, respectively, of total consolidated total revenue and service revenue, net. 

The following table summarizes property and equipment, net by geographic region and is further broken down to show countries which account for 10% or more of total as of December 31, if any (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

2018

 

 

2017

 

Property and equipment, net:

 

 

 

 

 

 

 

 

United States

 

$

38,609

 

 

$

37,535

 

Europe

 

 

 

 

 

 

 

 

Belgium

 

 

6,014

 

 

 

4,132

 

Other

 

 

5,500

 

 

 

5,134

 

Total Europe

 

 

11,514

 

 

 

9,266

 

Other

 

 

2,132

 

 

 

1,938

 

Total property and equipment, net

 

$

52,255

 

 

$

48,739

 

 

Revenue by Category

The following table disaggregates the Company’s revenue by major source (in thousands):

 

 

 

Year Ended

December 31, 2018

 

Therapeutic Area

 

 

 

 

Oncology

 

$

189,026

 

Other

 

 

161,194

 

Metabolic

 

 

94,128

 

Cardiology

 

 

91,824

 

AVAI

 

 

76,739

 

Central Nervous System

 

 

53,904

 

Endocrine

 

 

26,002

 

Medical Devices

 

 

11,772

 

      Total revenue

 

$

704,589

 

 

 

- 111 -


17. QUARTERLY FINANCIAL DATA (unaudited)

The following table summarizes the Company's unaudited quarterly results of operations (in thousands, except per share data):

 

 

2018

 

 

First Quarter

 

 

Second Quarter

 

 

Third Quarter

 

 

Fourth Quarter

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenue

$

163,077

 

 

$

170,144

 

 

$

179,253

 

 

$

192,115

 

Total direct costs

 

117,254

 

 

 

116,676

 

 

 

123,996

 

 

 

131,133

 

Income from operations

 

20,119

 

 

 

23,345

 

 

 

26,918

 

 

 

30,666

 

Net income

 

14,551

 

 

 

16,568

 

 

 

19,305

 

 

 

22,761

 

Net income per share attributable to common shareholders - Basic

$

0.41

 

 

$

0.46

 

 

$

0.54

 

 

$

0.64

 

Net income per share attributable to common shareholders - Diluted

$

0.40

 

 

$

0.45

 

 

$

0.52

 

 

$

0.61

 

 

 

2017

 

 

First Quarter

 

 

Second Quarter

 

 

Third Quarter

 

 

Fourth Quarter

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenue

$

106,611

 

 

$

106,216

 

 

$

110,643

 

 

$

112,682

 

Total direct costs

 

63,935

 

 

 

63,619

 

 

 

65,106

 

 

 

68,803

 

Income from operations

 

15,944

 

 

 

16,279

 

 

 

17,198

 

 

 

15,437

 

Net income

 

8,447

 

 

 

9,553

 

 

 

9,831

 

 

 

11,291

 

Net income per share attributable to common shareholders - Basic

$

0.21

 

 

$

0.24

 

 

$

0.25

 

 

$

0.30

 

Net income per share attributable to common shareholders - Diluted

$

0.20

 

 

$

0.23

 

 

$

0.25

 

 

$

0.30

 

 

 

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 

None.

Item 9A. Controls and Procedures 

Limitations on Effectiveness of Controls and Procedures

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated, as of the end of the period covered by this Annual Report on Form 10-K, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)). Based on that evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were not effective due to a material weakness in the Company’s internal control over financial reporting as disclosed in Part II, Item 8 of this Annual Report on Form 10-K.

Management’s Annual Report on Internal Control Over Financial Reporting

Our management’s report on internal control over financial reporting is set forth in Part II, Item 8 of this Annual Report on Form 10-K and is incorporated herein by reference.

- 112 -


Changes in Internal Control over Financial Reporting

During the year ended December 31, 2018, we implemented material changes to our revenue recognition processes in response to the adoption of ASU No. 2014-09 “Revenue from Contracts with Customers (Topic 606)” that became effective January 1, 2018. These included the development of new policies based on the five-step model provided in the new revenue standard, new training, ongoing contract review requirements, and gathering of information provided for disclosures. The operating effectiveness of these changes has been evaluated as part of our annual assessment of the effectiveness of internal controls over financial reporting. The operating effectiveness of internal controls over financial reporting is discussed in Part II, Item 8 of this Annual Report on Form 10-K.

Item 9B. Other Information 

As previously described, on August 10, 2018, we ceased to be a “controlled company” within the meaning of the rules of the Nasdaq. Nasdaq rules require that immediately upon ceasing to be a controlled company, at least one member of the nominating and corporate governance committee (if applicable) and the compensation committee be independent.  Within 90 days of ceasing to be a controlled company, a majority of the compensation committee must be independent, and within 12 months of ceasing to be a controlled company, all members of the compensation committee must be independent. As of August 10, 2018, all of the members of the Company’s compensation committee were independent. The Company does not have a nominating or corporate governance committee.

- 113 -


PART III

Item 10. Directors, Executive Officers and Corporate Governance.

The information required by this item will be included in our definitive proxy statement (or the “Proxy Statement”) for our 2019 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of our fiscal year covered by this Annual Report and is incorporated herein by reference.

Item 11. Executive Compensation 

The information required by this item will be included in our Proxy Statement for our 2019 Annual Meeting of Stockholders, and is incorporated herein by reference.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 

The information required by this item will be included in our Proxy Statement for our 2019 Annual Meeting of Stockholders, and is incorporated herein by reference.

The information required by this item will be included in our Proxy Statement for our 2019 Annual Meeting of Stockholders, and is incorporated herein by reference.

Item 14. Principal Accountant Fees and Services 

The information required by this item will be included in our Proxy Statement for our 2019 Annual Meeting of Stockholders, and is incorporated herein by reference.

- 114 -


PART IV

Item 15. Exhibits, Financial Statement Schedules 

(1) Financial Statements

The following financial statements and supplementary data are included in Item 8 of this annual report:

 

 

 

Page

Report of Independent Registered Public Accounting Firm

 

72

Consolidated Balance Sheets

 

73

Consolidated Statements of Operations

 

74

Consolidated Statements of Comprehensive Income

 

75

Consolidated Statements of Changes in Shareholders' Equity

 

76

Consolidated Statements of Cash Flows

 

77

Notes to Consolidated Financial Statements

 

78

 

(2) Financial Statement Schedules

The information required to be submitted in the Financial Statement Schedules for Medpace Holdings, Inc. and subsidiaries has either been shown in the financial statements or notes, or is not applicable or required under Regulation S-X; therefore, those schedules have been omitted.

(3) Exhibits

The exhibits listed in the accompanying Exhibit Index following the signature page are filed or furnished as a part of this report and are incorporated herein by reference.

 

Item 16. Form 10-K Summary

None. 

- 115 -


EXHIBIT INDEX

 

 

 

 

 

Incorporated by Reference

 

 

Exhibit
Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing
Date

 

Filed/
Furnished
Herewith

 

 

 

 

 

 

 

 

 

 

 

 

 

  3.1

 

Amended and Restated Certificate of Incorporation of Medpace Holdings, Inc.

 

8-K

 

001-37856

 

3.1

 

8/16/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  3.2

 

Amended and Restated Bylaws of Medpace Holdings, Inc.

 

8-K

 

001-37856

 

3.2

 

8/16/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  4.1

 

Specimen Stock Certificate evidencing shares of common stock

 

S-1/A

 

333-212236

 

4.1

 

7/26/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  4.2

 

Voting Agreement

 

10-Q

 

001-37856

 

4.2

 

11/3/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.1

 

Medpace Holdings, Inc. 2016 Incentive Award Plan

 

10-Q

 

001-37856

 

10.1

 

11/3/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.2

 

Medpace Holdings, Inc. 2016 Senior Executive Incentive Bonus Plan

 

10-Q

 

001-37856

 

10.2

 

11/3/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  10.3

 

Registration Rights Agreement

 

10-Q

 

001-37856

 

10.3

 

11/3/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.4

 

Form of Medpace Holdings, Inc. 2016 Incentive Award Plan Restricted Stock Award Grant Notice

 

S-1/A

 

333-212236

 

10.13

 

8/1/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.5

 

Form of Medpace Holdings, Inc. 2016 Incentive Award Plan Stock Option Grant Notice and Stock Option Agreement

 

S-1/A

 

333-212236

 

10.14

 

8/1/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.6

 

Form of Medpace Holdings, Inc. 2016 Incentive Award Plan Restricted Stock Unit Award Grant Notice.

 

S-1/A

 

333-212236

 

10.15

 

8/1/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.7

 

Medpace Holdings, Inc. 2016 Incentive Award Plan Sub-Plan for UK Participants

 

S-1/A

 

333-212236

 

10.16

 

8/1/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.8

 

Amended and Restated Employment Agreement, by and between Medpace Holdings, Inc. and Dr. August J. Troendle

 

S-1/A

 

333-212236

 

10.18

 

7/26/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.9

 

Medpace Holdings, Inc. 2016 Incentive Award Plan UK Company Share Option Plan (CSOP) Sub-Plan

 

S-1/A

 

333-212236

 

10.19

 

8/1/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

#10.10

 

Medpace Holdings, Inc. Non-Employee Director Compensation Policy revised effective October 25, 2018

 

10-Q

 

001-37856

 

10.1

 

10/30/18

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.11

 

Credit Agreement, dated as of December 8, 2016, by and among Medpace IntermediateCo, Inc., as parent guarantor, each lender from time to time party thereto and Wells Fargo Bank, National Association, as Administrative Agent

 

8-K

 

001-37856

 

10.1

 

12/8/16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 21.1

 

List of Subsidiaries of Medpace Holdings, Inc.

 

 

 

 

 

 

 

 

 

*

- 116 -


 

 

 

 

Incorporated by Reference

 

 

Exhibit
Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing
Date

 

Filed/
Furnished
Herewith

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 23.1

 

Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm

 

 

 

 

 

 

 

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

 31.1

 

Rule 13a-14(a) / 15d-14(a) Certification of Chief Executive Officer

 

 

 

 

 

 

 

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

 31.2

 

Rule 13a-14(a) / 15d-14(a) Certification of Chief Financial Officer

 

 

 

 

 

 

 

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

 32.1

 

Section 1350 Certification of Chief Executive Officer

 

 

 

 

 

 

 

 

 

**

 

 

 

 

 

 

 

 

 

 

 

 

 

 32.2

 

Section 1350 Certification of Chief Financial Officer

 

 

 

 

 

 

 

 

 

**

 

 

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

 

 

 

 

 

 

 

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

 

 

 

 

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

101.CAL

 

XBRL Taxonomy Calculation Linkbase Document

 

 

 

 

 

 

 

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

 

 

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

 

 

 

 

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation

 

 

 

 

 

 

 

 

 

*

 

*

Filed herewith.

**

Furnished herewith.

#

Indicates management contract or compensatory plan.

 

- 117 -


SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

MEDPACE HOLDINGS, INC.

 

By:

 

/s/ JESSE J. GEIGER

 

 

Name:

 

Jesse J. Geiger

 

 

Title:

 

Chief Financial Officer, and Chief Operating Officer, Laboratory Operations

 

 

 

 

 

 

 

Date:

 

February 26, 2019

 

We, the undersigned, hereby severally constitute and appoint Dr. August J. Troendle and Jesse J. Geiger, and each of them singly, our true and lawful attorneys with full power to them and each of them to sign for us, in our names and capacities below, any and all amendments to this Annual Report on Form 10-K filed with the Securities and Exchange Commission.

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

 

Signature

 

Capacity

Date

 

 

 

 

/s/ AUGUST J. TROENDLE

 

President, Chief Executive Officer and Chairman of the Board of Directors (Principal Executive Officer)

 

Dr. August J. Troendle

 

February 26, 2019

 

 

 

 

 

 

 

/s/ JESSE J. GEIGER

 

Chief Financial Officer, and Chief Operating Officer, Laboratory Operations (Principal Financial and Accounting Officer)

 

Jesse J. Geiger

 

February 26, 2019

 

 

 

 

/s/ BRUCE BROWN

 

Director

 

Bruce Brown

 

February 26, 2019

 

 

 

 

/s/ BRIAN T. CARLEY

 

Director

 

Brian T. Carley

 

February 26, 2019

 

 

 

 

/s/ ROBERT O. KRAFT

 

Director

 

Robert O. Kraft

 

February 26, 2019

 

 

 

 

/s/ FRED B. DAVENPORT JR.

 

Director

 

Fred B. Davenport Jr.

 

February 26, 2019

 

 

 

 

/s/ CORNELIUS P. MCCARTHY III

 

Director

 

Cornelius P. McCarthy III

 

 

February 26, 2019

 

- 118 -

medp-ex211_10.htm

Exhibit 21.1

 

LIST OF SUBSIDIARIES OF MEDPACE HOLDINGS, INC.

Jurisdiction of Organization

 

Entity Name

Delaware

 

Medpace Acquisition, Inc.

Delaware

 

Medpace IntermediateCo, Inc.

Ohio

 

Imagepace, LLC

Ohio

 

Medpace Clinical Pharmacology LLC

Ohio

 

Medpace, Inc.

Ohio

 

Medpace Reference Laboratories LLC

 

medp-ex231_8.htm

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in Registration Statement No. 333-213116 on Form S-8 and Registration Statement No. 333-220306 on Form S-3 of our report dated February 26, 2019, relating to the financial statements of Medpace Holdings, Inc. and subsidiaries (the “Company”) (which report expresses an unqualified opinion and includes an explanatory paragraph related to the Company’s change in method of accounting for revenue from contracts with customers in fiscal year 2018), appearing in this Annual Report on Form 10-K of Medpace Holdings, Inc. and subsidiaries for the year ended December 31, 2018.

 

/s/ Deloitte & Touche LLP

Cincinnati, Ohio

February 26, 2019

 

medp-ex311_6.htm

 

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Dr. August J. Troendle, certify that:

1.

I have reviewed this Annual Report on Form 10-K of Medpace Holdings, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.

The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: February 26, 2019

 

By:

 

/s/ August J. Troendle

 

 

 

 

Dr. August J. Troendle

 

 

 

 

President, Chief Executive Officer and Chairman of the Board of Directors

(Principal Executive Officer)

 

 

medp-ex312_9.htm

 

Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Jesse J. Geiger, certify that:

1.

I have reviewed this Annual Report on Form 10-K of Medpace Holdings, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.

The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: February 26, 2019

 

By:

 

/s/ Jesse J. Geiger

 

 

 

 

Jesse J. Geiger

 

 

 

 

Chief Financial Officer and Chief Operating Officer, Laboratory Operations

(Principal Financial Officer)

 

 

medp-ex321_7.htm

 

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report of Medpace Holdings, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2018 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company for the periods presented therein.

 

Date: February 26, 2019

 

By:

 

/s/ August J. Troendle

 

 

 

 

Dr. August J. Troendle

 

 

 

 

President, Chief Executive Officer and

 

 

 

 

Chairman of the Board of Directors

 

 

 

 

(Principal Executive Officer)

 

 

medp-ex322_11.htm

 

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report of Medpace Holdings, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2018 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company for the periods presented therein.

 

Date: February 26, 2019

 

By:

 

/s/ Jesse J. Geiger

 

 

 

 

Jesse J. Geiger

 

 

 

 

Chief Financial Officer and Chief Operating Officer, Laboratory Operations

 

 

 

 

(Principal Financial Officer)