|Traded as||NASDAQ: GILD
S&P 500 Component
NASDAQ Biotechnology Component
|Headquarters||Foster City, California, U.S.|
|John C. Martin,
|Products||AmBisome, Atripla, Cayston, Emtriva, Flolan, Harvoni, Hepsera, Letairis, Lexiscan, Macugen, Ranexa, Sovaldi, Tamiflu, Truvada, Viread, Vistide|
|Revenue||US$32.639 billion (2015)|
|US $22.193 billion (2015)|
|US $18.108 billion (2015)|
|Total assets||US $51.839 billion (2015)|
|Total equity||US $19.113 billion (2015)|
Number of employees
|7,900 (2015) |
Gilead Sciences is an American biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza. In 2006, Gilead acquired two companies which were developing drugs to treat patients with pulmonary diseases.
The company's current commercially available products include Atripla, Complera, Emtriva, Viread, Tybost, Vitekta, Truvada, Stribild, Harvoni, Hepsera, Sovaldi, Zydelig, Letairis, Lexiscan, Ranexa, Cayston, Tamiflu, AmBisome, and Macugen.
Headquartered and founded in Foster City, California, Gilead has operations in North America, Europe and Australia. As of the end of 2015, the company had approximately 7,900 full-time employees. Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500.
|Gregg Alton of Gilead Sciences & others, "The Evolution of HIV/AIDS Therapies: A Conversation", 2012, Chemical Heritage Foundation|
Gilead Sciences was founded in June 1987 by Michael L. Riordan, a medical doctor who was 29 years old at the time. Riordan graduated from Washington University, the Johns Hopkins School of Medicine and the Harvard Business School. Three core scientific advisers worked with Riordan to create the company and establish its scientific vision. These were Peter Dervan of Caltech, Doug Melton of Harvard, and Harold Weintraub of the Fred Hutchinson Cancer Research Center. Riordan served as CEO from inception until 1996. Menlo Ventures, a venture capital firm where Riordan worked for a year, made the first investment in Gilead, of $2 million, and Menlo's partner DuBose Montgomery served as Chairman of the Board until 1993, when Riordan became Chairman. Riordan also recruited as scientific advisers Harold Varmus, a Nobel laureate who later became Director of the National Institutes of Health, and Jack Szostak, recipient of the Nobel Prize for Physiology or Medicine in 2009.
The company's primary therapeutic focus was, and continues to be, in antiviral medicines, a field that interested Riordan because he contracted dengue fever, an untreatable viral disease, while working in malnutrition clinics as a Henry Luce Scholar in the Philippines. Riordan recruited Donald Rumsfeld to join the board of directors in 1988, followed by Benno C. Schmidt, Sr., Gordon Moore, and George P. Shultz. Riordan tried to recruit Warren Buffett as an investor and board member, but was unsuccessful. Under the technical leadership of scientist Dr. Mark Matteucci, the company focused its early discovery research on making small strands of DNA (oligomers) to assess the potential of genetic code blockers (gene therapy). Its development of small molecule antiviral therapeutics began in 1991 when CEO Riordan and R&D head John C. Martin in-licensed a group of nucleotide compounds discovered in two European academic labs; one of the compounds was tenofovir, a pro-drug of which, trade named Viread, became one of the most widely used anti-AIDS drugs.
In 1990, Gilead entered into a collaborative research agreement with Glaxo for the research and development of genetic code blockers, also known as antisense. This collaboration was terminated in 1998, and Gilead's antisense intellectual property portfolio was sold to Isis Pharmaceuticals.
In June 1996, Gilead launched Vistide (cidofovir injection) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The company cooperated with Pharmacia & Upjohn to market the product outside the United States.
In January 1997, Donald Rumsfeld, a Board member since 1988, was appointed Chairman of the company. He stood down from the Board in January 2001 when appointed United States Secretary of Defense at the start of George W. Bush's first term as President. Federal disclosure forms indicate that Rumsfeld owned between US$5 million and US$25 million in Gilead stock. The rise in Gilead's share prices from US$35 to US$57 per share will have added between US$2.5 million to US$15.5 million to Rumsfeld's net worth.
In March 1999, Gilead acquired NeXstar Pharmaceuticals of Boulder, Colorado following two years of negotiations with the company. At the time, NeXstar's annual sales of $130 million was three times Gilead's sales. NeXstar's two revenue-generating drugs were AmBisome, an injectable fungal treatment, and DaunoXome, an oncology drug taken by HIV patients. Also in 1999, Roche announced first approval of Tamiflu (oseltamivir) for the treatment of influenza. Tamiflu was originally discovered by Gilead and licensed to Roche for late-phase development and marketing. Viread (tenofovir) achieved first approval in 2001 for the treatment of HIV.
In January 2003, Gilead completed its acquisition of Triangle Pharmaceuticals. The company also announced its first full year of profitability. Later that year Hepsera (adefovir) was approved for the treatment of chronic hepatitis B, and Emtriva (emtricitabine) for the treatment of HIV.
In November 2005, President George W. Bush urged the United States Congress to pass $7.1 billion in emergency funding to prepare for the possible bird flu pandemic, of which $1 billion is solely dedicated to the purchase, and distribution of Tamiflu.
In July 2006, the U.S. Food and Drug Administration (FDA) approved Atripla, a once a day single tablet regimen for HIV, combining Sustiva (efavirenz), a Bristol-Myers Squibb product, and Truvada (emtricitabine and tenofovir disoproxil), a Gilead product.
Gilead purchased Raylo Chemicals, Inc. in November 2006 for a price of $133.3 million. Raylo Chemical, based in Edmonton, Alberta, was a wholly owned subsidiary of Degussa AG, a German company. Raylo Chemical was a custom manufacturer of active pharmaceutical ingredients and advanced intermediates for the pharmaceutical and biopharmaceutical industries.
On July 16, 2012, the U.S. FDA approved the first drug shown to reduce the risk of HIV infection manufactured by Gilead Sciences. The pill Truvada as a preventive measure (PrEP) for people who are at high risk of getting HIV through sexual activity.
Citing a market capitalization of US$113 billion and stock appreciation of 100%, and describing their 2011 purchase of Pharmasset for $11 billion as “one of the best pharma acquisitions ever”, Gilead Sciences was reported as the number 4 ranked drug company of 2013 by Forbes Magazine. The strong performance of Gilead in 2013 has also been linked to the FDA approval, and strong sales performance, of their “potentially revolutionary” Hepatitis-C drug Sovaldi. with US 4Q’13 sales estimated by Deutsche Bank at $53M.
On July 11, 2014, the Committee of Finance of the United States Senate launched an investigation into the pricing of the hepatitis C drug Sovaldi (sofosbuvir). This was in reaction to the high cost per pill ($1,000), which raised serious questions about the extent to which the market was operating “efficiently and rationally” for this drug. In a letter to CEO John C. Martin, Senators Ron Wyden (Chairman) and Charles E. Grassley (Member) asked Gilead to provide a series of documents to the Committee, and to answer a list of questions, in order for the Committee to get a better understanding of how the company had arrived at the price for this drug.
Entry into the cardiovascular and respiratory therapeutic areas
Myogen, based in Boulder, Colorado, was completing Phase 3 studies of ambrisentan—now marketed as "Letairis"—an orally available endothelin receptor antagonist. The U.S. FDA subsequently approved ambrisentan for the treatment of pulmonary arterial hypertension in June 2007.
Under an agreement with GlaxoSmithKline, Myogen marketed Flolan (epoprostenol sodium) in the United States for the treatment of primary pulmonary hypertension. Additionally, Myogen was developing (in Phase 3 studies) darusentan, also an endothelin receptor antagonist, for the potential treatment of resistant hypertension.
The other acquisition was Corus Pharma. Corus's lead product candidate, aztreonam lysine for inhalation, is an antibiotic with activity against gram-negative bacteria including Pseudomonas aeruginosa, which can cause lung infections in patients with cystic fibrosis. The product is in Phase 3 studies. Gilead also obtained an inhalation formulation of two antibiotics for treatment of respiratory infections.
Gilead expanded its move into respiratory therapeutics in 2007 by entering into a licensing agreement with Parion for an epithelial sodium channel inhibitor for the treatment of pulmonary diseases, including cystic fibrosis, chronic obstructive pulmonary disease and bronchiectasis.
Current Gilead Sciences CEO is John F. Milligan.
Timetable of mergers and acquisitions
|1999||NeXstar Pharmaceuticals||$550 million||NeXstar had two drugs (AmBisome and DaunoXome) of which only AmBisome is still in Gilead's portfolio, although it is not a major source of income for the company. DaunoXome was sold to Diatos in 2006. As important as the products, NeXstar also provided Gilead with a much-needed sales force and commercialization team in Europe and Australia, and a manufacturing plant in San Dimas, California.|
|2003||Triangle Pharmaceuticals||$464 million||Triangle owned the development and commercialization rights to emtricitabine, which although marketed as a stand-alone product (Emtriva), is also a component of the more profitable combination products Atripla and Truvada.|
|2006||Corus Pharma, Inc.||$365 million||The acquisition of Corus signaled Gilead's entry into the respiratory arena. Corus was developing aztreonam lysine for the treatment of patients with cystic fibrosis who are infected with Pseudomonas aeruginosa|
|2006||Myogen, Inc.||$2.5 billion||With two drugs in development (ambrisentan and darusentan), and one marketed product (Flolan) for pulmonary diseases, the acquisition of Myogen has solidified Gilead's position in this therapeutic arena.|
|2006||Raylo Chemicals, Inc.||$148 million||This Edmonton, Alberta site will be used for process research and for manufacturing compounds for both clinical studies and commercial products.|
|2007||Nycomed fr. Altana - Cork||$47 million||This commercial manufacturing site was purchased by Gilead in place of building out the site in Dublin. This site used to be Altana in Cork which was purchased by Nycomed.|
|2009||CV Therapeutics, Inc.||$1.4 billion||This acquisition brings Ranexa and Lexiscan as commercial products. Ranexa is a cardiovascular drug used to treat chest pain related to coronary artery disease. These products and pipeline build out Gilead's cardiovascular franchise.|
|2010||CGI Pharmaceuticals||$120 million||This acquisition helps to broaden Gilead's research expertise into kinase biology and chemistry.|
|2010||Arresto Biosciences, Inc.||$225 million||This acquisition brings Gilead developmental-stage research for treating fibrotic diseases and cancer.|
|2011||Calistoga Pharmaceuticals||$375 million ($225 million additional w/ milestones)||Acquisition of Calistoga bolsters areas of oncology and inflammation.|
|2011||Pharmasset, Inc||$10.4 billion||This acquisition helps Gilead take the lead in HCV with 7977 (Sofosbuvir).|
|2013||YM Biosciences, Inc||$510 million||This acquisition brings drug candidate CYT387, an orally-administered, once-daily, selective inhibitor of the Janus kinase (JAK) family, specifically JAK1 and JAK2. The JAK enzymes have been implicated in a number of disorders including myeloproliferative diseases, inflammatory disorders and certain cancers.|
|2015||Phenex Pharmaceuticals||up-to $470 million||This acquisition will revolve around the Phenexs Farnesoid X Receptor (FXR) program, which consists of utilising small molecule FXR agonists in the treatment of liver diseases such as nonalcoholic steatohepatitis|
|2015||EpiTherapeutics||$65 million||This acquisition will give Gilead first-in-class small molecule inhibitors of histone demethylases involved in regulating gene transcription in cancer.|
|2015||Galapagos NV||$725 million||This acquisition will give Gilead access to experimental anti-inflammatory drug filgotinib which is planned to treat rheumatoid arthritis, ulcerative colitis, and Crohn's disease.|
|2016||Nimbus Apollo, Inc.||$400 million||This acquisition will give Gilead the compound NDI-010976 (an ACC inhibitor) and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis and for the potential treatment of hepatocellular carcinoma|
Board of directors
Gilead's Executive Committee is responsible for making the critical decisions that determine the company's future. Its members include:
|John F. Milligan, PhD||President and Chief Executive Officer|
|Norbert W. Bischofberger, PhD||Executive Vice President, Research and Development and Chief Scientific Officer|
|Robin L. Washington, MBA||Executive Vice President and Chief Financial Officer|
|John McHutchison, MD||Executive Vice President, Clinical Research|
|Gregg H. Alton, JD||Executive Vice President, Corporate and Medical Affairs|
|Paul Carter||Executive Vice President, Commercial Operations|
|William A. Lee, PhD||Executive Vice President, Head of Antiviral Therapeutics|
|James R. Meyers||Senior Vice President, Commercial Operations, North America|
|Taiyin Yang, PhD||Executive Vice President, Pharmaceutical Development and Manufacturing|
|Andrew Cheng, MD, PhD||Executive Vice President, Clinical Research and Development Operations|
|Katie L. Watson||Executive Vice President, Human Resources|
Gilead has 21 products on the market.
Gilead's pipeline focuses on HCV, HIV, cardiovascular and respiratory disorders.
|Drug Name||Description||Potential Indication||Testing Phase|
|Cobicistat/Tybost (formerly GS-9350)||Pharmacokinetic enhancer||HIV/AIDS||submitted for US + EU approval|
|Elvitegravir (formerly GS-9137)||Integrase inhibitor||HIV/AIDS||submitted for US + EU approval|
|Single Tablet Regimen||elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide||HIV/AIDS||Phase III|
|Single Tablet Regimen||darunavir, cobicistat, emtricitabine, and tenofovir alafenamide||HIV/AIDS||Phase II|
|Single Tablet Regimen||sofosbuvir and ledipasvir||Hepatitis C||Phase III|
|GS-5816||pan-genotypic NS5A inhibitor||Hepatitis C||Phase II|
|GS-9451||NS3 Protease inhibitor||Hepatitis C||Phase II|
|GS-9669||non-nucleoside NS5B inhibitor||Hepatitis C||Phase II|
|Ledipasvir (formerly GS-5885)||NS5A inhibitor||Hepatitis C||Phase III|
|GS-9620||TLR-7 agonist||Hepatitis C/Hepatitis B||Phase I|
|Tenofovir alafenamide (TAF) (formerly GS-7340)||nucleotide reverse transcriptase inhibitor||Hepatitis B||Phase I|
|GS-4774||Tarmogen T cell immunity stimulator||Hepatitis B||Phase I|
|Simtuzumab (formerly GS-6624)||Humanized monoclonal antibody||Liver Fibrosis/Idiopathic Pulmonary Fibrosis/Myelofibrosis/Pancreatic Cancer||Phase II|
|GS-9973||Syk inhibitor||B-Cell Malignancies||Phase II|
|GS-9820 (formerly CAL-120)||PI3K delta inhibitor||Lymphoid Malignancies||Phase II|
|GS-5745||MMP9 mAb inhibitor||Ulcerative Colitis/Solid Tumors||Phase I|
|Momelotinib||Janus kinase inhibitor||Myelofibrosis||Phase II|
|Ranolazine||Late sodium current inhibitor||Coronary Artery Disease/Diabetes||Phase III|
|Single Tablet Regimen||Ranolazine and Dronedarone||Paroxysmal Atrial Fibrillation||Phase II|
|GS-6615||Ischemic Heart Disease and Arrhythmias||Phase I|
|GS-5806||Respiratory Syncytial Virus||Phase II|
Terminated from product pipeline
Gilead no longer develops these products
|Drug Name||Description||Potential Indication||Development Terminated at|
|Aztreonam||inhalation solution||Bronchiectasis||Phase II|
|GS-9256||Protease inhibitor||Hepatitis C||Phase II|
|GS-9310/11||inhaled fosfomycin/tobramycin||Cystic Fibrosis/Chronic Obstructive Pulmonary Disease||Phase II|
|GS-9667 (formerly CVT-3619)||Partial A1 adenosine agonist||Diabetes/Dyslipidemia||?|
|GS-6201 (formerly CVT-6883)||A2B adenosine antagonist||Pulmonary diseases||Phase I|
|GS-6620||Nucleotide polymerase inhibitor||Hepatitis C||Phase I|
|GS-9411||Epithelial sodium channel blocker||Pulmonary diseases||Phase I|
|Tegobuvir (formerly GS-9190)||Non-nucleoside polymerase inhibitor||Hepatitis C||Phase II|
|Cicletanine||Antihypertensive||Pulmonary arterial hypertension||Phase II|
|CVT-10216||ALDH-2 inhibitor||Drug addiction||preclinical|
|Tecadenoson||Selective A1 adenosine receptor||Atrial fibrillation||?|
|Perfan||Enoximone||Heart failure||Phase III|
|GS-9219||Nucleotide analogue||Non-Hodgkin’s lymphoma and Chronic lymphocytic leukemia||Phase I|
|GS-424020||Prodrug of Desisobutryl-ciclesonide and salmeterol||Asthma and Chronic obstructive pulmonary disease||preclinical|
|GS-9148||Nucleotide analog, phosphonomethoxy-2'-fluoro-2', 3'-dideoxydidehydroadenosine||HIV/AIDS||preclinical|
|GS-9131||Prodrug of GS-9148||HIV/AIDS||preclinical|
|CAL-263||PI3K Delta selective inhibitor||inflammatory diseases||Phase I|
|GS-9820 (formerly CAL-120)||PI3K Delta selective inhibitor||inflammatory diseases||preclinical|
|CAL-129||PI3K Delta selective inhibitor||inflammatory diseases and oncology||preclinical|
|CAL-253||PI3K Delta selective inhibitor||inflammatory diseases and oncology||preclinical|
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