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Achillion Pharmaceuticals 2013 Annual Report

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Achillion Pharmaceuticals 2013 Annual Report ACHILLION PHARMACEUTICALS DESTINATION: 2013 ANNUAL REPORT CURING HCV WORLDWIDE ACHILLION PHARMACEUTICALS, INC. PHARMACEUTICALS, ACHILLION 2013 ANNUAL REPORT ANNUAL 2013 Achillion Pharmaceuticals, Inc. 300 George Street • New Haven, CT 06511 www.achillion.com 87933_ACH_2013_outsidecover.indd 1 4/8/14 12:20 PM DEAR ACHILLION SHAREHOLDER CORPORATE INFORMATION Milind S. Deshpande, Ph.D. President and Chief Executive Officer In my fi rst letter to you as Chief Executive Offi cer of Achillion, Our strategic and tactical responses to the clinical hold on sovapre- EXECUTIVE MANAGEMENT BOARD OF DIRECTORS CORPORATE COUNSEL I am pleased to review the past year, share with you our plans and vir were swift. Recall that in June 2013, sovaprevir was put on clin- AND CORPORATE OFFICERS David I. Scheer, Wilmer Cutler Pickering Hale anticipated milestones, and outline my vision for the Company. ical hold by the FDA due to elevations in sovaprevir concentrations Milind S. Deshpande, Ph.D. Chairman of the Board and Dorr LLP At Achillion, we are dedicated to conducting rigorous scientifi c and elevations in liver enzymes observed in drug-drug interaction President and President New York, NY discovery and development. Thanks to our extremely talented studies with ketoconazole and with ritonavir-boosted atazanavir. Chief Executive Offi cer Scheer & Co., Inc. employees, I am proud to say that all the compounds in our pipe- As we work with the FDA to resolve the clinical hold on sovapre- INDEPENDENT AUDITORS vir, we rapidly integrated ACH-2684 into our clinical development David Apelian, M.D., Ph.D. Milind S. Deshpande, Ph.D. line were discovered and advanced from our research laboratories. PricewaterhouseCoopers LLP plans, keeping intact our strategy of creating a triple combination Executive Vice President and President and By harnessing our core expertise in biology, medicinal chemistry, Chief Medical Offi cer Chief Executive Offi cer Hartford, CT structural biology, as well as the expertise of our staff in clinical therapy. ACH-2684 is a potent inhibitor of HCV replication and has clinically demonstrated excellent effi cacy in HCV patients. Achillion Pharmaceuticals, Inc research and development, Achillion has successfully advanced Mary Kay Fenton TRANSFER AGENT & REGISTRAR multiple compounds into clinical development at a rate that we Finally, we ended 2013 with approximately $159 million in cash, Executive Vice President and Jason Fisherman, M.D. Computershare Shareholder believe exceeds industry benchmarks. With great talent, great cash equivalents and marketable securities to deploy in our Chief Financial Offi cer Managing Director Services, Inc. compounds, and the fi nancial resources we believe are suffi cient to pipeline programs. With these fi nancial resources available to us, Synthesis Capital Gautam Shah, Ph.D. (781) 575-2879 advance our programs, I believe Achillion is positioned for success. we believe we can achieve a number of value creating milestones Executive Vice President and P.O. Box 30170 throughout 2014. Furthermore, this capital is expected to be suffi - Gary E. Frashier During the past year, the future of HCV treatment became clearer. Chief Compliance Offi cer College Station, TX 77842-3170 cient to support our operations into 2016. President While still affecting more than 150 million patients worldwide, we Management Associates Joseph Truitt now believe that HCV can be cured in more than 90% of patients During 2014, from our on-going clinical trials and planned mile- CORPORATE HEADQUARTERS within 6 to 8 weeks with a treatment that can be safe and well stones, we remain focused on creating high effi cacy, short duration Executive Vice President and Kurt Graves 300 George Street tolerated. Our focus is on developing these commercially compet- treatment regimens for HCV. First and foremost is the start of phase Chief Commercial Offi cer Chief Executive Offi cer New Haven, CT 06511 itive regimens. We believe our pipeline enables us to pursue two 1 with ACH-3422. The initial safety and proof-of-concept trial is Intarcia Therapeutics (203) 624-7000 distinct strategies to achieve this goal. With the advancement of expected to begin during the second quarter of 2014 and to provide Michael D. Kishbauch ACH-3422, a uridine-analog NS5B nucleotide polymerase prodrug, antiviral data during the third quarter. In parallel, we are initiating Former President and into the clinic, this compound could serve as the backbone of a a phase 2 pilot trial of ACH-3102 in combination with sofosbuvir, a INVESTOR RELATIONS Chief Executive Offi cer of pan-genotypic regimen that potentially could be used in combina- marketed NS5B nucleotide polymerase inhibitor, seeking to develop Glenn Schulman, Pharm.D., M.P.H. Achillion Pharmaceuticals, Inc. tion with our NS5A inhibitor and NS3/4A protease inhibitor to cure insight into the effi cacy of ACH-3102 in combination with our nu- [email protected] all genotypes of HCV. Also, by leveraging ACH-3102, our second- cleotide, ACH-3422. We will explore not only eight-week treatment Dennis Liotta, Ph.D. generation NS5A inhibitor, as a backbone compound for the durations with this regimen, but potentially a shorter six-week Professor of Chemistry COMMON STOCK treatment of genotype 1b HCV, we believe we have the capability regimen for genotype 1 HCV. We also plan to initiate a phase 2 trial Emory University Achillion Pharmaceuticals, Inc. to address this most prevalent strain of HCV worldwide. of ACH-3102 in combination with ACH-2684. This trial is expected common stock trades on the Robert L. Van Nostrand We believe that the Achillion HCV portfolio is well positioned to to begin mid-2014 and we plan to report results during the fourth NASDAQ Global Select Market Former Chief Financial Offi cer deliver a commercially competitive treatment for HCV, and during quarter of the year. We believe the data generated to date, as under the symbol ACHN of Aureon Laboratories, 2013 we achieved multiple milestones that laid the ground work well as the additional data that we anticipate could be generated throughout 2014, will support the potential of our proprietary com- AGI Dermatics and to achieve that goal. Specifi cally, the discovery and rapid advance- ANNUAL MEETING bination of HCV drug candidates to generate high cure rates over a OSI Pharmaceuticals ment of ACH-3422 is potentially transformational. ACH-3422 has Tuesday, June 3, 2014 short duration of therapy for a large portion of the HCV market. demonstrated high potency and a high barrier to resistance against Nicole Vitullo 9:00 a.m. Eastern Daylight Time HCV in vitro. With the addition of ACH-3422 to our HCV portfolio, The possibility of curing and even eradicating HCV with an all-oral Partner 300 George Street, 8th Floor Achillion is one of very few companies having each of a propri- treatment regimen was beyond comprehension just a few years Domain Associates New Haven, CT 06511 etary nucleotide (ACH-3422), a NS5A inhibitor (ACH-3102), and a ago. With the combination regimens being developed by Achillion, NS3/4A protease inhibitor (ACH-2684). Based on emerging clinical I believe Achillion is strongly positioned to compete in the global data, it is apparent that a combination of these three mechanisms HCV market. With the broad expertise and dedication of our em- may be essential to achieve short duration treatment with a high ployees, I am confi dent in Achillion’s ability to make a difference Important Note About Forward-Looking Statements cure rate. Hence, during 2014 we look forward to the clinical in the lives of patients and continue to achieve success in the years This report contains forward looking statements regarding our research and development programs, operating results, fi nancial condition, results from our combination studies with ACH-3422. to come. business strategies and prospects. You can identify these forward looking statements by such terms as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would” or other words that convey uncertainty of future Also in 2013, two phase 2 trials with ACH-3102 were conducted. Thank you for your support. events or outcomes. Our actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including: our ability to obtain marketing approvals from the FDA and similar foreign regulatory authorities for The fi rst 12-week therapeutic trial with ACH-3102 plus ribavirin Sincerely, demonstrated safety and a high barrier to resistance. The second our product candidates; our ability to complete the development of our drug candidates under the timelines we anticipate in current and future clinical trials; our ability to obtain patent protection for our drug candidates and freedom to operate under third party intellectual 12-week trial in combination with sovaprevir, another of our prote- property; our ability to establish commercial manufacturing arrangements and to identify, enter into and maintain collaboration agree- ase inhibitors, plus ribavirin established safety, a very rapid decline ments with appropriate third-parties; our ability to launch commercial sales of our drug candidates, whether alone or in collaboration in HCV RNA in GT1a and GT1b subjects, and high effi cacy at 100% with others; and our ability to achieve profi tability and raise the additional capital needed to achieve our business objectives. These and SVR12 in GT-1b subjects. We believe these data support a triple other risks are described in greater detail under the heading “Risk Factors” in the accompanying Annual Report on Form 10-K. combination of ACH-3422, ACH-3102, plus a protease inhibitor as a Milind Deshpande, Ph.D. Achillion does not undertake any obligation to update any forward-looking statements contained in this document as a result of new potential pan-genotypic, short treatment duration therapy for HCV. President and Chief Executive Offi cer Concept and Design by Calfo Group information, future events or otherwise.
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