Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 19, 2016 Alnylam Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-36407 77-0602661 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 300 Third Street, Cambridge, MA 02142 (Address of Principal Executive Offices) (Zip Code) Registrant’s telephone number, including area code: (617) 551-8200 Not applicable (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below): Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 1.01. Entry Into a Material Definitive Agreement. On September 19, 2016, Alnylam Pharmaceuticals, Inc. (the “Company”) entered into indemnification agreements (each, an “Indemnification Agreement”) with each of its current directors and executive officers (each, an “Indemnitee”) in the applicable form previously approved by the Board of Directors of the Company (the “Board”). Each Indemnification Agreement clarifies and supplements indemnification provisions already contained in the Company’s Certificate of Incorporation and Delaware law. Each Indemnification Agreement provides that the Company will indemnify the respective Indemnitee to the maximum extent permitted by Delaware law against all judgments, fines, penalties, excise taxes and amounts paid in settlement and all expenses actually and reasonably incurred by the Indemnitee or on his or her respective behalf in connection with a proceeding. Each Indemnitee is not entitled to indemnification if it is established that one of the exclusions to indemnification, set forth in each Indemnification Agreement, exists. The foregoing description of each Indemnification Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the forms of Indemnification Agreement, copies of which were filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 and are incorporated herein by reference. Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers. Effective September 19, 2016, the Company appointed Yvonne Greenstreet, MBChB, MBA, to the position of Executive Vice President, Chief Operating Officer of the Company. Barry E. Greene will continue to serve as the Company’s President. Prior to joining the Company, Dr. Greenstreet, 54, most recently served as the founder and Managing Director of Highgate LLC, from January 2014 to August 2016, working with life sciences companies to help develop strategies that transform businesses, bring medicines to market and maximize shareholder value. Prior to that time, Dr. Greenstreet served as the Senior Vice President and Head of Medicines Development at Pfizer Inc. (“Pfizer”), a multinational pharmaceutical company, from December 2010 to November 2013. Prior to joining Pfizer, Dr. Greenstreet worked for 18 years at GlaxoSmithKline plc (“GSK”), a multinational pharmaceutical, biologics, vaccines and consumer healthcare company, where she served in various positions, most recently as Senior Vice President and Chief of Strategy for Research and Development and as a member of GSK’s Product Management Board. Dr. Greenstreet currently serves on the Scientific Advisory Committee of the Bill and Melinda Gates Foundation. Dr. Greenstreet holds a Bachelor of Medicine, Bachelor of Surgery from the University of Leeds, United Kingdom and an M.B.A. from INSEAD, France. In connection with her employment with the Company, Dr. Greenstreet will receive an annual base salary of $500,000. Dr. Greenstreet will also receive an initial sign-on bonus of $100,000 upon commencement of employment (the “Bonus”). In the event Dr. Greenstreet voluntarily terminates her employment with the Company or is terminated by the Company for cause, within twelve months of her effective date of employment, Dr. Greenstreet will be required to repay the full gross amount of the Bonus. Dr. Greenstreet will also be eligible for an annual cash bonus (commencing with a pro-rated bonus for 2016) under the Company’s Annual Incentive Program with an annual incentive target of 50% of her annual base salary, subject to the achievement of certain performance goals established by the Company. Achievement of Company goals will be determined by the Compensation Committee of the Board and any cash bonus paid will be calculated in accordance with the terms of such Annual Incentive Program. The Compensation Committee also approved the grant, effective as of September 19, 2016, to Dr. Greenstreet of non-qualified stock options to purchase an aggregate of 150,000 shares of Alnylam’s common stock. These options were granted as an inducement material to Dr. Greenstreet’s entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4). The stock options have a ten-year term and an exercise price equal to $77.10, the per share closing price of the Company’s common stock as reported by NASDAQ on the date of grant. Options to purchase 125,000 shares will vest over four years, with 25% vesting on the first anniversary of the grant date and the remainder vesting ratably at the end of each three-month period thereafter over the remaining three years, and options to purchase 25,000 shares will vest upon the later of the one year anniversary of the date of grant and the launch of the Company’s first internally developed product, assuming in each case Dr. Greenstreet remains continuously employed by the Company as of such date. Dr. Greenstreet will also be eligible for reimbursement of certain relocation expenses, as well as all other compensation and benefit plans available to the Company’s executive officers. On September 19, 2016, Dr. Greenstreet also entered into an Indemnification Agreement with the Company consistent with the agreements described in Item 1.01 of this Current Report on Form 8-K. Item 7.01. Regulation FD Disclosure On September 19, 2016, the Company issued a press release announcing Dr. Greenstreet’s appointment as Chief Operating Officer. A copy of this press release is furnished as Exhibit 99.1 to this Report on Form 8-K. The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing. Item 9.01. Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release dated September 19, 2016, furnished herewith. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ALNYLAM PHARMACEUTICALS, INC. Date: September 19, 2016 By: /s/ Michael P. Mason Michael P. Mason Vice President, Finance and Treasurer EXHIBIT INDEX Exhibit No. Description 99.1 Press Release dated September 19, 2016, furnished herewith. Exhibit 99.1 Contacts: Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom (Investors and Media) 617-682-4340 Josh Brodsky (Investors) 617-551-8276 Alnylam Expands and Strengthens Management Team as it Plans for Commercialization – Dr. Yvonne Greenstreet and Dr. Emmanuel Dulac Join Alnylam, Bringing Significant Product Strategy, Portfolio Management, and Commercialization Experience – Cambridge, Mass., September 19, 2016 – Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today two key appointments to its senior leadership team, expanding the breadth of talent and experience as the company prepares for commercialization of its pipeline and global expansion. Dr. Yvonne Greenstreet has joined as Executive Vice President, Chief Operating Officer, and Dr. Emmanuel Dulac as Senior Vice President, Chief Commercial Officer. Both Drs. Greenstreet and Dulac offer decades of life science experience in drug development and successfully launching medicines to the market in areas of unmet needs. In addition, both have worked in global capacities and have supported execution on strategies involving substantial organizational growth. Barry Greene will continue to serve as the Company’s President. “With our rapid pipeline growth and maturity toward commercial stages, we’re focused on building our team to achieve our Alnylam 2020 goals. In this regard, the appointments of Yvonne and Emmanuel significantly bolster the depth of product experience and commercial expertise in our growing organization,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “I’m confident that their insight and leadership will help us realize our mission of building a top-tier biopharmaceutical company founded on RNAi and speed the path of bringing potentially life changing new therapies to patients through innovative drug development, commercial, and patient access strategies.” Dr. Greenstreet will report to John Maraganore, and will have responsibility for leading the company’s multi-disciplinary product teams from early development through and during commercialization. In this capacity Yvonne will have responsibility for the global General Managers (currently in place for ATTR programs, fitusiran, and ALN-CC5), Program Leaders, and the Program Management team, which are all focused on progressing development pipeline programs through to launch and commercialization. Additionally, she will be responsible for leading the Alliance Management team primarily focused on our partnership with Sanofi Genzyme. “It’s a pleasure to join the team at Alnylam at such an important time in the company’s evolution, where RNAi therapeutics are advancing toward commercial stages,” said Dr. Greenstreet. “Alnylam’s pipeline is one of the most exciting in the industry, and I’m thrilled to be part of a team pioneering new medicines to meet unmet needs for patients. This is a vitally important mission where I believe I can add significant value.” Dr. Greenstreet brings 25 years of global experience in the pharmaceutical industry, where she has been in senior roles in research and development, strategy, and portfolio management, and has successfully led product development and commercialization teams in a wide range of therapy areas, bringing new medicines to patients. Dr. Greenstreet was previously Senior Vice President and Head of Medicines Development at Pfizer, with accountability for a portfolio that included the immuno-inflammation, vaccines, specialty neuroscience, and rare disease areas. Prior to Pfizer, she held roles of increasing responsibility at GlaxoSmithKline, including Senior Vice President and Chief of Strategy for Research and Development, Senior Vice President for Medicines Development, and Chief Medical Officer for Europe. Dr. Greenstreet holds a Bachelor of Medicine, Bachelor of Surgery from the University of Leeds, UK and Master of Business Administration (MBA) from INSEAD, France. She serves as an advisor and board member for several public companies and also serves on the Scientific Advisory Committee for the Bill and Melinda Gates Foundation. Dr. Dulac will report to Barry Greene, and will be responsible for establishing Alnylam’s global commercial footprint. He will lead the development of the global commercial expertise area, building global commercial capabilities, including support of patients post product launch, and building the U.S. commercial operations. “I feel fortunate to be joining Alnylam at a time when we have the opportunity to develop and shape our commercial strategies for a ground breaking new approach to treating disease. RNAi therapeutics have now passed the proof of concept stage and have the potential to profoundly transform patients’ lives. It gives us the potential to target many unserved diseases with an extremely precise medicine and an uncommonly long duration of activity. I feel privileged to have been entrusted to build and lead a top-tier organization that will attract the best talent in the industry and bring these truly differentiated medicines to patients,” said Dr. Dulac. Dr. Dulac brings to Alnylam more than 20 years of international experience in the biotech and pharmaceutical industry. He joins the company from Shire, where he was Senior Vice President, Head of the Rare Disease Business Unit. Prior to Shire, Emmanuel held various roles of increasing responsibility at Sanofi, Abbott, and Novartis in global, regional and local functions. During his career, he successfully launched six brands, led two blockbuster drugs globally, and built large sales organizations, innovative patient services, and strong marketing and market access teams. He graduated from the University of Paris XI with a Doctorate in Pharmacology (PharmD, Ph.D.) and completed an MBA from the ESSEC School in Paris. About RNAi RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way. About Alnylam Pharmaceuticals Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is leading the translation of RNAi as a new class of innovative medicines. Alnylam’s pipeline of investigational RNAi therapeutics is focused in 3 Strategic Therapeutic Areas (STArs): Genetic Medicines, with a broad pipeline of RNAi therapeutics for the treatment of rare diseases; Cardio-Metabolic Disease, with a pipeline of RNAi therapeutics toward genetically validated, liver-expressed disease targets for unmet needs in cardiovascular and metabolic diseases; and Hepatic Infectious Disease, with a pipeline of RNAi therapeutics that address the major global health challenges of hepatic infectious diseases. In early 2015, Alnylam launched its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics as a whole new class of innovative medicines. Specifically, by the end of 2020, Alnylam expects to achieve a company profile with 3 marketed products, 10 RNAi therapeutic clinical programs – including 4 in late stages of development – across its 3 STArs. The company’s demonstrated commitment to RNAi therapeutics has enabled it to form major alliances with leading companies including Ionis, Novartis, Roche, Takeda, Merck, Monsanto, The Medicines Company, and Sanofi Genzyme. In addition, Alnylam holds an equity position in Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 200 peer-reviewed papers, including many in the world’s top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, Cell, New England Journal of Medicine, and The Lancet . Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information about Alnylam’s pipeline of investigational RNAi therapeutics, please visit www.alnylam.com. Alnylam Forward-Looking Statements Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including without limitation, Alnylam’s views with respect to the potential for RNAi therapeutics, its expectations regarding its STAr pipeline growth strategy, and its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, Alnylam’s ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all, actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing, delays, interruptions or failures in the manufacture and supply of our product candidates, obtaining, maintaining and protecting intellectual property, Alnylam’s ability to enforce its intellectual property rights against third parties and defend its patent portfolio against challenges from third parties, obtaining and maintaining regulatory approval, pricing and reimbursement for products, progress in establishing a commercial and ex-United States infrastructure, competition from others using technology similar to Alnylam’s and others developing products for similar uses, Alnylam’s ability to manage its growth and operating expenses, obtain additional funding to support its business activities, and establish and maintain strategic business alliances and new business initiatives, Alnylam’s dependence on third parties for development, manufacture and distribution of products, the outcome of litigation, the risk of government investigations, and unexpected expenditures, as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.