CONTRACT RESEARCH ORGANIZATION INDUSTRY OVERVIEW

Transcription

1 CONTRACT RESEARCH ORGANIZATION INDUSTRY OVERVIEW April 2014 Investment banking services are provided by Harris Williams LLC, a registered broker-dealer and member of FINRA and SIPC, and Harris Williams & Co. Ltd, which is authorised and regulated by the Financial Conduct Authority. Harris Williams & Co. is a trade name under which Harris Williams LLC and Harris Williams & Co. Ltd conduct business.

2 Pre-Discovery Investigational New Drug (IND) Application Submitted New Drug Application (NDA) Submitted DRUG DISCOVERY AND DEVELOPMENT PROCESS Discovering and developing safe and effective pharmaceuticals is a challenging undertaking that can take 10 to 15 years and cost $1.0 to $1.5 billion. The drug development process requires sophisticated technology and a broad array of medical and laboratory expertise, which include: Disease target identification Preclinical evaluation Toxicology and safety testing Clinical trial design and implementation For every 5,000 to 10,000 potential compounds that are evaluated, ultimately only one receives approval from the FDA. DRUG DISCOVERY AND DEVELOPMENT PROCESS Drug Discovery Pre-Clinical Clinical Trials FDA Review Manufacturing Post-Approval Number of Compounds: k 5,000 10, Phase I Phase II Phase III Phase IV 1 FDA Approved Drug Number of Volunteers ,000 5, years 6 7 years years Indefinite Given the cost and time to develop drugs, pharmaceutical manufacturers and biotechnology companies are increasingly outsourcing development activities to remove fixed costs and gain efficiencies. Sources: Equity research and innovation.org. 1

3 CONTRACT RESEARCH ORGANIZATIONS Contract Research Organizations ( CROs ) offer outsourced services to support R&D functions for pharmaceutical, biotechnology, and medical device companies. CRO services span the range of research and development ( R&D ) activities including: drug discovery, pre-clinical (pre-human in-vitro and in-vivo animal research model), and clinical (in-human) testing. Growth in the CRO market will be driven by: 1 Growth in R&D spend 2 Increased outsourcing of R&D activities CRO MARKET GROWTH For the Years Ended and Ending December 31, 2013 to 2017P ($ in billions) '13 - '17P CAGR $40 $35 $30 $25 $20 $15 $10 $5 $0 $25.3 $19.9 $27.0 $21.2 Total: 6.6% Clinical: 6.4% Pre-clinical: 7.4% $28.8 $22.5 $30.6 $24.0 $32.7 $25.5 $5.4 $5.8 $6.2 $6.7 $ E 2015P 2016P 2017P Pre-clinical Clinical CRO CORE SERVICES Research model production and services Discovery services Toxicology studies Bioanalytical services Central laboratory Investigator and patient recruitment Site monitoring Data management services and technology Safety and pharmacovigilance Study and development program design and consulting Regulatory affairs advisory and a variety of post-marketing surveillance and consulting services Source: Equity research estimates. 2

4 GROWTH IN R&D SPEND SLOWING PATENT CLIFF AND INCREASED DRUGS APPROVALS After experiencing a significant loss of branded sales over the last five years, pharmaceutical manufacturers have seen an uptick in new drug approvals. From , approximately $65 billion of branded drugs came off patent protection. Pharmaceutical companies looking to stabilize profitability levels and maintain operating margins have introduced cost saving initiatives with R&D being a core target In addition, pharmaceutical companies shifted focus to late stage R&D development in an effort to drive drugs to market and replace lost revenue Early stage CROs experienced significant pricing pressure that began to stabilize in 2013 as capacity levels stabilized with some larger pre-clinical players closing capacity 39 compounds were approved by the FDA in 2012 that are expected to generate $16 billion in sales in the fifth year after launch. 1 BRAND SALES AT RISK For the Years Ended and Ending December 31, 2007 to 2022P ($ in billions) INCREASE IN APPROVALS For the Years Ended and Ending December 31, 1999 to 2012 ($ in billions) $40 $35 $30 $25 $20 $15 $10 $5 $34.7 $22.2 $14.7 $15.1 $15.3 $14.5 $13.2 $11.2 $11.8 $9.8 $8.2 $9.0 $6.0 $7.2 $4.1 $2.1 $18 $16 $14 $12 $10 $8 $6 $4 $2 $7 $8 $9 $13 $8 $15 $7 $9 $5 $5 $6 $11 $10 $ $0 $0 0 USA Sales 5 Years After Launch Number of NMEs Approved Sources: Equity research, EvaluatePharma, and FDA. 3

5 GROWTH IN R&D SPEND DRIVING SALES GROWTH AND MODEST R&D SPEND GROWTH 1 Moderate global prescription drug sales growth is driving a 1.4% annual increase in R&D spend from $137 billion in 2012 to $149 billion in 2018P. Improving FDA approval levels and positive sales outlook are allowing pharmaceutical companies to allocate more capital to R&D spending. CROs are poised to provide the scientific expertise and infrastructure necessary to drive new drug candidates through the development process as the funding environment for biotechnology companies improves. The first half of 2013 yielded 16 biotechnology IPOs that raised $1.2 billion in capital PRESCRIPTION DRUG SALES GROWTH For the Years Ended and Ending December 31, 2012 to 2018P ($ in billions) $1,000 $900 $800 $700 $600 $500 $400 $300 $200 $100 $0 $716 $743 $ % CAGR $800 $831 $862 $ E 2015P 2016P 2017P 2018P $137 PHARMACEUTICAL R&D SPEND For the Years Ended and Ending December 31, 2012 to 2018P ($ in billions) $150 $148 $146 $144 $142 $140 $138 $136 $134 $132 $130 $139 $ % CAGR $143 $145 $147 $ E 2015P 2016P 2017P 2018P Source: EvaluatePharma. 4

6 INCREASED OUTSOURCING NAVIGATING COSTS AND COMPLEXITY 2 Increasingly complex protocols are driving increases in clinical trial costs, making it more difficult for pharmaceutical companies to recoup R&D investment and driving outsourcing. Significant increases to drug development costs are driven by: Increasing complexity of clinical trials Greater number of regulatory hurdles Investment in state-of-the-art technology A growing number of pharmaceutical companies are partnering with CROs who have the required infrastructure and expertise to manage costs and deadlines. By outsourcing a portion or all of the drug development process to CROs, pharmaceutical companies can more easily manage costs by converting fixed costs into variable costs. COST PER NEW APPROVED DRUG ($ in millions) $1,400 $1,200 $1,000 $800 $ % Increase $800 $1,200 $400 $200 $140 $320 $0 Mid 1970s Mid 1980s Late 1990s Early 2000s Sources: Equity research and PhRMA. 5

7 INCREASED OUTSOURCING INTERNATIONAL REACH 2 Clinical trials are increasingly becoming global, placing a premium on CROs having global capabilities to serve their client s needs across geographies. Increased globalization of clinical trials is being driven by numerous factors: Increased speed of enrollment Faster approval of trials Access to global populations Cost considerations Involving local populations is subjected to local regulatory requirements Maximizing the value of R&D spend by receiving regulatory approval from several countries For the Years Ended December 31, 2004 to 2013 CRO GEOGRAPHIC REVENUE MIX 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 60% 54% 54% 52% 50% 49% 47% 46% 46% 43% 40% 46% 46% 48% 50% 51% 53% 54% 54% 57% International U.S. Note: CRO index includes Albany Molecular Research, Charles River Laboratories, Covance, ICON, PAREXEL, Quintiles, and WuXi PharmaTech. Sources: Public filings and equity research. 6

8 INCREASED OUTSOURCING GROWTH IN SPECIALTY DRUGS Pharmaceutical companies will increasingly rely on the robust infrastructure and clinical expertise of CROs as specialty drugs become a larger portion of the market. Approximately 8% of approved and marketed products today are specialty drugs, but it is estimated that over 42% of drugs in the development pipeline are specialty drugs. Outsourcing will be more important than ever to pharmaceutical companies as specialty drugs require highly tailored clinical trials and specific scientific expertise which significantly increase costs. Experience with biomarkers, genomics, companion diagnostics, and delivery routes will differentiate top-tier CROs The number of specialty drugs in the market is expected to increase 19% over its 2011 level to 42% in 2016P. 2 SPECIALTY DRUGS IN THE MARKET IN 2011 For the Year Ended December 31, 2011 SPECIALTY DRUGS IN THE MARKET IN 2016P For the Year Ending December 31, 2016P Traditional Drugs 77% Specialty Drugs 23% Traditional Drugs 58% Specialty Drugs 42% Sources: Equity research and Omnicare, Inc analyst day event data. 7

9 INDUSTRY EVOLUTION CROs have evolved from being a provider of additional capacity to being an integral element in the drug discovery and development process. CROs arose in the 1970s to provide spill-over capacity for a limited group of services. Data management, clinical site monitoring, and biostatistical analysis Not viewed as strategic partners due to concerns over quality of work and scientific expertise In the 1980s, rising development costs forced pharmaceutical companies to partner with CROs to increase efficiency and lower the overall cost of bringing a drug to market. To further improve profitability levels and reduce margin pressure, pharmaceutical companies began utilizing preferred provider lists in the early 2000s and more recently creating strategic partnerships with CROs. 1980s 1990s Early 2000s Mid 2000s - Today Events Synopsis Model Transactional / Functional Service Provider Preferred Vendors Strategic Partnerships CROs are mainly used as spill-over capacity for pharmaceutical companies CROs began expanding their portfolio of offerings to become a broader provider of services The performance of the CRO industry suffered due to pharma / biotech consolidation Rise of the pharma / biotech companies that utilize CROs for strategic outsourcing Consistent demand from clients and profitability levels allow CROs to improve scale Numerous CRO IPOs Glaxo / SmtihKlineBeecham and Pfizer / Pharmacia mergers Quintiles taken private in 2003 Pressures from the recession, pharma / biotech consolidation, and pipeline rationalization depresses industry growth Reduction of internal capacity levels at pharma companies and growth in strategic partnerships drive outsourced penetration Big Pharma mergers in 08 and 09 Several CROs are taken private Rise of the strategic partnership model Source: Equity research. 8

10 STRATEGIC PARTNERSHIPS Strategic partnerships with big pharmaceutical companies are driving market share gains for top-tier CROs. Large pharmaceutical and biotechnology players have recently moved away from using preferred provider lists and have shifted toward creating strategic partnerships with only one or two CROs. Over 50% of biopharmaceutical companies use less than 5 preferred providers Approximately 50% of potential partnerships have already been awarded Partnership agreements do not include minimum purchase commitments Given the level of investment needed to transition protocols to CROs, typical strategic partnership relationships are considered to be sticky with contract terms ranging from 3 to 5 years, leading to increased visibility. NUMBER OF PREFERRED PROVIDERS USED KNOWN STRATEGIC PARTNERSHIPS Date Announced CRO Partner % % % None 6% % July-13 Quintiles Ascendancy Healthcare May-13 Quintiles Merck April-13 Lab Corp / Quintiles Bristol-Myers Squibb October-12 Charles River Laboratories AstraZeneca May-12 Covance Bayer Healthcare April-12 PRA International Amgen August-11 ICON Bristol-Myers Squibb May-11 ICON / PAREXEL Pfizer February-11 Covance / Quintiles Takeda February-11 Pharmaceutical Product Development Elan January-11 PAREXEL Merck September-10 Covance Sanofi-Aventis September-10 PAREXEL / Pharmaceutical Product Development GlaxoSmith Kline September-10 PAREXEL Eli Lilly June-10 ICON / PAREXEL Bristol-Myers Squibb November-09 Quintiles AstraZeneca November-09 ICON Eli Lilly July-09 Covance Merck June-09 ICON Eli Lilly August-08 Covance Eli Lilly Trend towards strategic partnerships will continue to drive strategic M&A as larger CROs attempt to fill out their full spectrum of service offerings. Sources: ContractPharma 2013, company data, and equity research. 9

11 CRO SERVICE OFFERING HW&Co. expects continued M&A activity as CROs fill out their service offering across the drug development spectrum and position themselves for strategic partnerships. KEY PLAYERS AND SERVICES OFFERED Early Stage Late Stage Other Pre-Clinical Clinical Peri-Approval Research Models Discovery Services Chemistry Bioanalysis Toxicology Phase I Phase II Phase III Central Lab Imaging Phase IV Consulting CSO / Commercialization Publically Traded CROs Charles River P P P P P P Covance P P P P P P P P P P P P P ICON P P P P P P P P P P Lab Corporation P PAREXEL P P P P P P P P P Quest Diagnostics P Quintiles P P P P P P P P WuXi P P P P P P P P Private CROs Celerion P P P P Harlan Sprague P P P P INC Research P P P P P P P inventiv P P P P P P MPI Research P P P P P PPD P P P P P P P P P P PRA International P P P P P P Ricera Biosciences P P P P Taconic P WIL Research P P P P Source: Equity research. 10

12 MARKET PERFORMANCE Despite encountering several instances of volatility, the CRO industry has trended upward and outperformed the broader market over the last decade. CRO MARKET PERFORMANCE For the Years Ended December 31, 1999 to 2013 and Three Months Ended March 31, % 600% 500% 400% Concerns over big pharma consolidation arise due to Pfizer / Pharmacia merger Continued bookings and revenue growth led to rally In a limited funding environment with foreign exchange headwinds, concerns over pharma and biotech consolidation re-appear Significant increase in the number of CRO strategic partnerships Quintiles completes its second IPO since % 200% 100% 0% S&P 500 CRO Sources: Equity research and Capital IQ. 11

13 MARKET VALUATION PUBLIC COMPANIES TEV / EBITDA CURRENT TRADING PERFORMANCE ($ in millions) 18x 12x 15.5x 14.1x 13.9x 12.9x 12.3x 11.6x Median: 12.9x 10.0x 6x 0x Enterprise Value Revenue Three-Year Revenue CAGR EBITDA Margin WuXi PharmaTech Quintiles Covance ICON Charles River $2,196 $7,831 $5,040 $2,277 Laboratories $3, ,808 2,402 1,336 1, % 7.6% 7.7% 14.1% 0.9% 25.4% 14.6% 15.1% 13.2% 22.1% PAREXEL $2,837 1, % 13.1% Albany Molecular Research $ % 19.1% FIVE-YEAR TRADING STATISTICS (INDEXED TEV / LTM EBITDA) 1 COMPARABLE COMPANY TEV / LTM EBITDA 1 ( 09 14) 16x CONTRACT RESEARCH ORGANIZATIONS 5.9x 5-Year Min 9.8x 5-Year Median 13.4x Current 14.6x 5-Year Max 12x 8x 4x Apr-09 Apr-10 Apr-11 Apr-12 Apr-13 Apr-14 S&P 500 Index CRO Comparables Index (1) Market capitalization weighted. Sources: Capital IQ and company filings. 12

14 OVERVIEW OF PRECEDENT COMPARABLE TRANSACTIONS CRO transactions have traded at a median 11.6x LTM EBITDA multiple. ($ in millions) Enterprise Enterprise Value/LTM Target Target Company Acquirer Date Value Sales EBITDA Contract Research Organizations Aptiv Solutions, Inc. ICON Public Limited Company Pending $143.5 Confidential 1.3 x 15.9 x Medpace, Inc. Cinven Limited Apr Galapagos NV, CRO Services Division Charles River Laboratories International, Inc. Mar x 12.0 x Lifetree Clinical Research, L.C. PRA International, Inc. Dec ReSearch Pharmaceutical Services, Inc. PRA International, Inc. Sep Novella Clinical, Inc. Quintiles Transnational Corp. Sep PRA International, Inc. Kohlberg Kravis Roberts & Co. Jun HERON Group Limited PAREXEL International Corporation Apr BioClinica, Inc. JLL Partners Mar x 10.5 x ClinStar, LLC PRA International, Inc. Mar Vital River Laboratories Co., Ltd. Charles River Laboratories International, Inc. Jan Liquent PAREXEL International Corporation Dec Confidential 1.9 x 12.0 x Accugenix, Inc. Charles River Laboratories International, Inc. Aug Caprion Proteomics Chicago Growth Partners Jul Confidential 3.8 x 11.1 x eresearchtechnology, Inc. Genstar Capital, LLC Jul x 9.0 x SeraCare Life Sciences, Inc. Linden LLC Apr x 13.4 x BioReliance Corporation SAFC, Inc. Jan x -- Pharmaceutical Product Development, LLC Hellman & Friedman LLC; The Carlyle Group LP Dec-11 3, x 10.4 x PharmaNet Development Group, Inc. inventiv Health Inc. Jul Kendle International Inc. INC Research, LLC Jul x 14.3 x Ingenix, Inc., i3 Clinical Development Businesses inventiv Health Inc. Jun ReSearch Pharmaceutical Services, Inc. Warburg Pincus LLC Feb x 15.1 x Lifetree Clinical Research, L.C. CRI Worldwide, LLC Jan INC Research, LLC Teachers' Private Capital; Avista Capital Holdings, L.P. Aug inventiv Health Inc. Thomas H. Lee Partners, L.P. Aug-10 1, x 8.7 x BioDuro, LLC Pharmaceutical Product Development, LLC Nov Excel PharmaStudies, Inc. Pharmaceutical Product Development, LLC Nov MDS Pharma Services INC Research, LLC Jul Piedmont Research Center, LLC Charles River Laboratories International, Inc. May PharmaNet Development Group, Inc. JLL Partners Mar x 8.6 x Low of Entire Group: $ x 8.6 x Median of Contract Research Organizations: $ x 11.6 x High of Entire Group: $3, x 15.9 x Sources: Capital IQ, company filings, and press releases. 13

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