Gilead Sciences

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Gilead Sciences
Public
Traded as
Industry Pharmaceutics
Biotechnology
Founded 1987; 30 years ago (1987)
Headquarters Foster City, California, U.S.
Key people
John F. Milligan (CEO)
John C. Martin (Chairman)
Revenue Decrease US $30.4 billion (2016)[1]
Decrease US $13.5 billion (2016)[2]
Number of employees
7,900 (2015) [3]
Website www.gilead.com

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 currently produces a range of commercially available products, most notably the Hepatitis C drugs: Harvoni and Sovaldi.[4]

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.[5][6] Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500.

The company's name and logo refer to the Balm of Gilead, inspired by a 1965 play by Lanford Wilson featuring the underworld adventures of the patrons of the namesake cafe.

History[edit]

Foundation[edit]

External video
Gregg Alton crop 2012 CHF HIV AIDS 058.jpg
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.[7][8][9] Riordan graduated from Washington University, the Johns Hopkins School of Medicine and the Harvard Business School.[10][11][12] 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.[13] 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.[9] 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.[14]

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.[15][16] 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.[17] 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-retroviral drugs.[18]

1990-1999: IPO[edit]

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. Gilead debuted on the NASDAQ in January 1992. Its initial public offering raised $86.25 million in proceeds.

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.[19] 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.[20]

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.

2000-2009: Growth through acquisition[edit]

In January 2003, Gilead completed its acquisition of Triangle Pharmaceuticals. 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.[21] 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 2004, Gilead launched Truvada, a fixed-dose combination of tenofovir and emtricitabine.

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 2006, Gilead completed two acquisitions that allowed the company to branch out from its historical antiviral franchise into the cardiovascular and respiratory therapeutic arenas. 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,[22] also an endothelin receptor antagonist, for the potential treatment of resistant hypertension.

In 2006, the company acquired Corus Pharma, Inc. for $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. 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.[23][24] Gilead purchased Raylo Chemicals, Inc. in November 2006 for a price of $133.3 million.[25] 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. Later in the same year Gilead acquired Myogen, Inc. for $2.5 billion (then it's largest acquisition). 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.

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.[26]

In 2009, the company acquired CV Therapeutics, Inc. for $1.4 billion, bringing Ranexa and Lexiscan into Gilead. Ranexa is a cardiovascular drug used to treat chest pain related to coronary artery disease, with both of these products and pipeline building out Gilead's cardiovascular franchise.[27] Later, in the same year the company received the award for one of the Fastest Growing Companies by Fortune. In the same year they were also named as one America's Top Companies to work for by Forbes.

Present decade[edit]

In 2010, the company acquired CGI Pharmaceuticals for $120 million, expanding Gilead's research expertise into kinase biology and chemistry. Later that year, the company acquired Arresto Biosciences, Inc. for $225 million, obtaining developmental-stage research for treating fibrotic diseases and cancer.[28]

In 2011, the company acquired Calistoga Pharmaceuticals for $375 million ($225 million plus milestone payments). The acquisition boosted Gilead's oncology and inflammation areas.[29] Later that year, Gilead made its most important acquisition — and most expensive to date — with the $10.4 billion purchase of Pharmasset, Inc. This transaction helped cement Gilead as the leader in treatment of the hepatitis C virus by giving it control of sofosbuvir (see below).

On July 16, 2012, the FDA approved Gilead's Truvada, the first drug shown to reduce the risk of HIV infection. The pill was a preventive measure (PrEP) for people at high risk of getting HIV through sexual activity.[30]

In 2013, the company acquired YM Biosciences, Inc. for $510 million. The acquisition brings drug candidate CYT387, an orally-administered, once-daily, selective inhibitor of the Janus kinase (JAK) family, specifically JAK1 and JAK2, into Gilead's oncology pipeline. The JAK enzymes have been implicated in myeloproliferative diseases, inflammatory disorders, and certain cancers.

In 2015, the company made a trio of acquisitions:

  • It bought Phenex Pharmaceuticals for $470 million. Its Farnesoid X Receptor (FXR) program used small-molecule FXR agonists in the treatment of liver diseases such as nonalcoholic steatohepatitis.[31]
  • It bought EpiTherapeutics for $65 million. This acquisition gave Gilead first-in-class small molecule inhibitors of histone demethylases involved in regulating gene transcription in cancer.[32]
  • It paid $425 million for a 15% equity stake in Galapagos NV, with additional payments for Gilead to license the experimental anti-inflammatory drug filgotinib, which may treat rheumatoid arthritis, ulcerative colitis, and Crohn's disease.[33]

In 2016, the company acquired Nimbus Apollo, Inc. for $400 million, giving Gilead control of 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.[34][35]

Sovaldi and Harvoni[edit]

The drug sofosbuvir had been part of the 2011 acquisition of Pharmasset. In 2013, the FDA approved this drug, under the trade name Sovaldi, as a treatment for the hepatitis C virus. Forbes magazine ranked Gilead its number 4 drug company, 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”.[36] Deutsche Bank estimated Sovaldi sales in the year's final quarter would be $53 million,[37] and Barron's noted the FDA approval and subsequent strong sales of the “potentially revolutionary” drug as a positive indicator for the stock.[38]

On July 11, 2014, the United States Senate Committee on Finance investigated Sovaldi's high price ($1,000 per pill; $84,000 for the full 12-week regimen). Senators questioned the extent to which the market was operating “efficiently and rationally”, and committee chairman Ron Wyden (D-Oregon) and ranking minority member Chuck Grassley (R-Iowa) wrote to CEO John C. Martin asking Gilead to justify the price for this drug.[39] The committee hearings did not result in new law, but in 2014 and 2015, due to negotiated and mandated discounts, Sovaldi was sold well below the list price.[40] For poorer countries, Gilead licensed multiple companies to produce generic versions of Sovaldi; in India, a pill's price was as low as $4.29.[41]

Merck & Co. combined Sovaldi with ledipasvir and marketed the treatment as Harvoni. This treatment for hepatitis C cures the patient in 94% to 99% of cases (HCV genotype 1).[42] By 2017, Gilead was reporting drastic drops in Sovaldi revenue from year to year, not only because of pricing pressure but because the number of suitable patients decreased.[43]

Prospects for the future[edit]

As of 2017, Gilead's challenge is to develop or acquire new blockbuster drugs before its current revenue-producers wane or their patent protection expires. Like other pharmaceutical companies, it stands to gain from efforts by U.S. President Donald Trump to repeal taxes imposed by the Affordable Care Act (ACA). However, Gilead also benefitted from the expansion of Medicaid in the ACA; Leerink analyst Geoffrey Porges wrote that Gilead's HIV drugs could face funding pressure under reform proposals.[44] Gilead has $32 billion in cash, but $27.4 billion is outside the U.S. and is unavailable for acquisitions unless Gilead pays U.S. tax on it, though it could borrow against it.[45] Gilead would benefit from proposals to let companies repatriate offshore capital with minimal further taxation.[46]

Acquisition history[edit]

Product portfolio[edit]

Gilead has 21 products on the market.

Product Portfolio
Brand Name Drug Name(s) Indication Date Approved (USA)[47] Marketing Partner(s) U.S. Patent Expiration[5] European Patent Expiration[5]
AmBisome liposomal amphotericin B fungal infection, cryptococcal meningitis, Aspergillus, Candida, Cryptococcus infections 1997-08-11 Astellas Pharma(USA)Rapiscan(EU) 2016 expired
Atripla tenofovir, emtricitabine, and efavirenz HIV, AIDS 2006-07-12 Bristol-Myers Squibb 2021 2018
Cayston Aztreonam Cystic Fibrosis 2010-02-22 2021 2021
Descovy Emtricitabine/tenofovir alafenamide 2016-04-04
Epclusa Velpatasvir/sofosbuvir Hepatitis C 2016-06-28
Complera/Eviplera tenofovir, emtricitabine, and rilpivirine HIV, AIDS 2011-08-10 Johnson and Johnson  
Emtriva emtricitabine HIV, AIDS 2003-07-02   2021 2016
Flolan epoprostenol sodium pulmonary hypertension 1995-09-20 GlaxoSmithKline expired expired
Genvoya Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 2015-11-05
Harvoni sofosbuvir, ledipasvir Hepatitis C 2014-10-10
Hepsera adefovir dipivoxil hepatitis B (HBV) 2002-09-20   2014 2011
Letairis ambrisentan Pulmonary arterial hypertension 2007-06-15 GlaxoSmithKline 2015 2015
Lexiscan regadenoson myocardial perfusion imaging 2008-04-10 Astellas 2019 2020
Macugen pegaptanib sodium solution age-related macular degeneration 2004-12-17 OSI and Pfizer 2017 2017
Odefsey Emtricitabine/rilpivirine/tenofovir alafenamide 2016-03-01
Ranexa ranolazine angina 2006-01-27 Hoffmann–La Roche 2019 2019
Sovaldi sofosbuvir Hepatitis C 2013-12-06
Stribild elvitegravir, cobicistat, emtricitabine, tenofovir HIV, AIDS 2012-08-27
Tamiflu oseltamivir phosphate influenza 1999-10-27 Hoffmann–La Roche 2016 2016
Truvada emtricitabine and tenofovir HIV, AIDS 2004-08-02   2021 2018
Tybost cobicistat HIV, AIDS 2013-09-25 (EU), 2014-09-24 (US)
Vemlidy Tenofovir alafenamide 2016-11-10
Viread tenofovir HIV, AIDS, hepatitis B 2001-10-26   2017 2018
Vistide cidofovir CMV retinitis 1996-06-26 Pfizer expired expired
Vitekta elvitegravir HIV, AIDS 2013-09-25 (EU), 2014-09-24 (US)
Zydelig idelalisib oncology, lymphoma 2014-07-23

See also[edit]

References[edit]

  1. ^ http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2243783
  2. ^ http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2243783
  3. ^ "Media FAQs". Gilead Sciences. Retrieved 2015-03-16. 
  4. ^ "Medicines". Gilead. Retrieved 16 December 2016. 
  5. ^ a b c Gilead Sciences (2010-03-01). "2009 Form 10-K Annual Report". SEC. Retrieved 2011-01-15. 
  6. ^ Krantz, Matt (March 20, 2015). "Workers at 11 companies haul in $3.5M each!". Gannet. USA Today. Retrieved 11 November 2015. 
  7. ^ Gilead IPO prospectus 1992 [1] page 39
  8. ^ Forbes Admin [2] Gilead Sciences Board Resolution
  9. ^ a b "History of Gilead Sciences, Inc. – FundingUniverse". fundinguniverse.com. 
  10. ^ [3] "Balms From Gilead" Washington University Magazine, Spring 1997.
  11. ^ [4] Gilead SEC IPO prospectus January 1992
  12. ^ Engineering Awards [5] 1996
  13. ^ [6] 1996 SEC offering prospectus
  14. ^ [7] page 37
  15. ^ Washington University Magazine [8] "Balms From Gilead", Spring 1997
  16. ^ Forbes Magazine,"The Golden Age of Antivirals", October 27, 2003 http://www.forbes.com/global/2003/1027/090_print.html
  17. ^ Buffett-Riordan Correspondence [9] 1998
  18. ^ [IPO prospectushttp://www.scribd.com/doc/176254938/Gilead-Sciences-Initial-Public-Offering-Prospectus-January-1992] January, 1992, page 7
  19. ^ "Donald H. Rumsfeld Named Chairman of Gilead Sciences" (Press release). Gilead Sciences. 1997-01-03. Archived from the original on 2007-06-19. Retrieved 2007-06-03. 
  20. ^ Schwartz, Nelson D. (2005-10-31). "Rumsfeld's growing stake in Tamiflu". CNN. Retrieved 2007-06-03. 
  21. ^ "Gilead Sciences to Acquire Triangle Pharmaceuticals for $464 Million" (Press release). Gilead Sciences. 2004-12-04. Retrieved 2007-08-15. 
  22. ^ "ClinicalTrials.gov - Information on Clinical Trials and Human Research Studies: Darusentan". Retrieved 2007-08-18. 
  23. ^ Pollack, Andrew (2006-07-13). "F.D.A. Backs AIDS Pill to Be Taken Once a Day". New York Times. Retrieved 2007-09-20. 
  24. ^ "U.S. Food And Drug Administration (FDA) Approves Atripla" (Press release). Gilead Sciences and Bristol-Myers Squibb. 2006-07-12. Retrieved 2007-12-15. 
  25. ^ "Gilead Sciences Completes Acquisition of Raylo Chemicals Inc." (Press release). Gilead Sciences. 2006-11-03. Retrieved 2007-06-07. 
  26. ^ "Parion Sciences and Gilead Sciences Sign Agreement to Advance Drug Candidates for Pulmonary Disease" (Press release). Gilead Sciences. 2007-08-15. Retrieved 2007-08-15. 
  27. ^ Reuters, via the New York Times. 12 March 2009. Gilead, a White Knight, to Buy CV Therapeutics
  28. ^ "Gilead Sciences to Acquire Arresto Biosciences for $225 Million; Deal Adds Pipeline Candidates for Fibrotic Diseases" (Press release). Gilead Sciences. 2010-12-20. Retrieved 2011-01-15. 
  29. ^ "Gilead Sciences to Acquire Calistoga Pharmaceuticals for $375 Million; Deal Adds Pipeline Candidates in Oncology and Inflammation --" (Press release). Gilead Sciences. 2011-02-22. Retrieved 2011-02-22. 
  30. ^ Perrone, Matthew. "FDA approves first pill to help prevent HIV". Today Health. NBC News. Retrieved 16 July 2012. 
  31. ^ "Gilead to Acquire Phenex's FXR Program for Up-to-$470M". GEN. 
  32. ^ "Gilead Boosts Cancer Pipeline With $65M EpiTherapeutics Buy". GEN. 
  33. ^ N/A, Zack's Market Research. "Gilead (GILD) Collaborates with Galapagos for Filgotinib". Yahoo Finance. Yahoo/Zack's. Retrieved 31 December 2015. 
  34. ^ "Gilead - Investors - News Release". 
  35. ^ "Gilead Sciences: Nimbus Drug Acquired, Offering Cure For Fatty Liver". Parent Herald. 
  36. ^ "Grading Pharma in 2013". Forbes. December 31, 2013. 
  37. ^ "Q4 Sovaldi Sales Tracking at $53 Million". Street Insider. January 3, 2014. 
  38. ^ "Stocks to Watch". Barrons. January 2, 2014. 
  39. ^ Sanger-katz, Margot (2014-08-02). "Critics Raise Concerns About Sovaldi". The New York Times. ISSN 0362-4331. Retrieved 2015-10-04. 
  40. ^ "Gilead Q4 2014 Earnings Call". 
  41. ^ Ketaki Gokhale (2015-12-28). "The same pill that cost $1,000 in the U.S. sold for $4 in India". Bloomberg. 
  42. ^ Keating GM (2015). "Ledipasvir/Sofosbuvir: a review of its use in chronic hepatitis C". Drugs. 75 (6): 675–85. doi:10.1007/s40265-015-0381-2. PMID 25837989. 
  43. ^ Michael Douglass (2017-03-09). "I Was Wrong About Gilead Sciences". The Motley Fool. 
  44. ^ Allison Gatlin (2017-04-06). "Will Gilead's HIV Franchise Plan Be Dashed On TrumpCare?". Investors Business Daily. 
  45. ^ Ben Levisohn (2017-03-13). "Gilead Sciences: Is an Incyte Deal 'Reasonable'?". Barron's. 
  46. ^ Ioannis Stamatopoulos (2017-02-12). "Pharma M&A In 2017: The Most Likely Deal Hunters". Seeking Alpha. Retrieved 2017-03-12. 
  47. ^ "Drugs@FDA: FDA Approved Drug Products". Food and Drug Administration. Retrieved 2011-01-15. 

External links[edit]