Gilead Sciences

Gilead Sciences, Inc. /ˈɡɪliəd/, is an American biopharmaceutical company headquartered in Foster City, California that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Gilead Sciences, Inc.
Public
Traded as
ISINUS3755581036 
IndustryPharmaceutics
Biotechnology
Founded1987 (1987)
HeadquartersFoster City, California, United States
Area served
Worldwide
Key people
Products
Revenue US$22.45 billion[1] (2019)
US$4.29 billion[1] (2019)
US$5.39 billion[1] (2019)
Total assets US$61.63 billion[1] (2019)
Total equity US$22.65 billion[1] (2019)
Number of employees
 11,800[1] (2019)
Websitewww.gilead.com/ 

Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500.

History

Foundation
External video
Gregg Alton of Gilead Sciences & others, "The Evolution of HIV/AIDS Therapies: A Conversation", 2012, Chemical Heritage Foundation via Vimeo

In June 1987, Gilead Sciences was originally founded under the name Oligogen[2] by Michael L. Riordan, a medical doctor.[3] Riordan graduated from Washington University in St. Louis, the Johns Hopkins School of Medicine, and the Harvard Business School.[4] Three scientific advisers worked with Riordan to create the company: Peter Dervan of Caltech, Doug Melton of Harvard, and Harold M. Weintraub of the Fred Hutchinson Cancer Research Center. Riordan served as CEO from the company's founding until 1996.[5][6] Menlo Ventures, a venture capital firm where Riordan had previously worked, made the first investment in Gilead of $2 million.[7] Riordan also recruited scientific advisers including 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.[8][9]

The company's primary therapeutic focus was in antiviral medicines, a field that interested Riordan after he contracted dengue fever.[10] Riordan recruited Donald Rumsfeld to join the board of directors in 1988,[11] followed by Benno C. Schmidt, Sr., Gordon Moore,[11] and George P. Shultz.[11] Riordan tried to recruit Warren Buffett as an investor and board member, but was unsuccessful.[3]

The company focused its early research on making small strands of DNA (oligomers, or more particularly, oligonucleotides) to target specific genetic code sequences – that is, antisense therapy, a form of gene therapy.[2] Because of the expected healing potential of such research, Oligogen soon changed its name to Gilead Sciences, after the reputed healing properties of the ancient Balm of Gilead.[2] By 1988, the company had moved its headquarters to Foster City's Vintage Park neighborhood, where it has been based ever since.[2] The company began to develop small molecule antiviral therapeutics in 1991, when the company in-licensed a group of nucleotide compounds including tenofovir.[3]

1990–1999: IPO

Gilead's antisense intellectual property portfolio was sold to Ionis 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.

In January 1997, Donald Rumsfeld was appointed Chairman, but left the board in January 2001 when he was appointed United States Secretary of Defense during George W. Bush's first term as President.[12]

In March 1999, Gilead acquired NeXstar Pharmaceuticals of Boulder, Colorado. At the time, NeXstar's annual sales of $130 million was three times Gilead's sales; it sold AmBisome, an injectable fungal treatment, and DaunoXome, an oncology drug taken by HIV patients. That same year, Roche announced FDA approval of Tamiflu (oseltamivir) for the treatment of influenza.[13] Tamiflu was originally discovered by Gilead and licensed to Roche for late-phase development and marketing.

One reason for entering into the Tamiflu licensing agreement was that with only 350 employees, Gilead still did not yet have the capability to sell its drugs directly to overseas buyers.[14] To avoid having to license future drugs in order to access international markets, Gilead simply acquired the 480-employee NeXstar, which had already built its own sales force in Europe to market AmBisome there.[14]

2000 to 2009

Viread (tenofovir) achieved first approval in 2001 for the treatment of HIV.[15]

In 2002, Gilead changed its corporate strategy to focus exclusively on antivirals, and sold its cancer assets to OSI Pharmaceuticals for $200 million.[16]

In December 2002, Gilead and Triangle Pharmaceuticals announced that Gilead would acquire Triangle for around $464 million; Triangle's lead drug was emtricitabine that was near FDA approval, and it had two other antivirals in its pipeline.[16][17] 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.

During this era, Gilead completed its gradual evolution from a biotech startup into a pharmaceutical company.[2][11] The San Francisco Chronicle noted that by 2003, the Gilead corporate campus in Foster City had expanded to "seven low-slung sand-colored buildings around a tiny lake on which ducks happily paddle."[2] Like many startups, Gilead originally leased its space, but in 2004, the company paid $123 million to buy all its headquarters buildings from its landlords.[11] However, even as Gilead developed its ability to distribute and sell its own drugs, it remained distinct from most pharmaceutical companies in terms of its strong reliance on subcontracting most of its manufacturing to contract manufacturing organizations.[18]

In 2004, Gilead launched Truvada. Years later, through efforts of activists and other groups, Gilead was convinced that a fixed-dose combination of tenofovir and emtricitabine could be used as a pre-exposure prophylactic against the transmission of HIV.[19]

In 2004, during the Avian Flu pandemic scare, Gilead Sciences' revenue from Tamiflu almost quadrupled to $44.6m as more than 60 national governments stockpiled the antiviral drug, though the firm had made a loss in 2003 before concern about the flu started. As stocks soared, US Defense Secretary and Pentagon chief Donald Rumsfeld sold shares of the company, receiving more than $5 million in capital gains, while still maintaining up to $25m-worth of shares by the end of the year. Sales of Tamiflu almost quadrupled again in 2005, to $161.6m, during which time the share price tripled. A 2005 report showed that, in all, Rumsfeld owned shares worth up to $95.9m, from which he got an income of up to $13m[20]. Rumsfeld profiting from his investments in Gilead during a pandemic scare while in office sparked controversy, with many mainstream news outlets reporting his investments as a conflict of interest, particularly after the Pentagon ordered $58m worth of Tamiflu for US troops in July 2005.[21] On October 27, 2005, Rumsfeld recused himself from any official decision making about the drug; the New York Times reported, "Mr. Rumsfeld will remain involved in matters related to the Pentagon response to an outbreak, so long as none affect Gilead."[22]

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,[23] 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.[24][25][26]

Gilead purchased Raylo Chemicals, Inc. in November 2006, for a price of US$133.3 million.[27] 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 its 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.[28]

In 2009, the company acquired CV Therapeutics, Inc. for $1.4 billion, bringing Ranexa and Lexiscan into Gilead.[29] 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.[29] Later that year, the company was named one of the Fastest Growing Companies by Fortune.[30][31] In the same year, they were also named as one America's Top Companies to work for by Forbes.

2010 to 2019

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.[32]

In February 2011, the company acquired Calistoga Pharmaceuticals for US$375 million ($225 million plus milestone payments). The acquisition boosted Gilead's oncology and inflammation areas.[33][34] Later that year, Gilead made its most important acquisition – and by then most expensive – with the US$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).

In October 2011, Gilead broke ground on a massive multi-year expansion of its 17-building headquarters campus in Foster City.[35] By replacing eight one or two-story buildings with seven new structures ranging as tall as 10 stories, Gilead nearly doubled its headquarters real estate footprint from about 620,000 square feet to about 1.2 million square feet.[35]

On July 16, 2012, the FDA approved Gilead's Truvada for prevention of HIV infection (it was already approved for treating HIV). The pill was a preventive measure (PrEP) for people at high risk of getting HIV through sexual activity.[36][37][38][39]

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 non-alcoholic steatohepatitis.[40]
  • 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.[41]
  • 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.[42]

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.[43][44] Also in 2016, the company was named the most generous company on the 2016 Fortune list of The Most Generous Companies of the Fortune 500. Charitable donations to HIV/AIDS and liver disease organizations totaled over 440 million in 2015.[45]

In August 2017, the company announced it would acquire Kite Pharma for $11.9 billion,[46] equating to $180 cash per share, a 29% premium over the closing price of the shares. The deal will add the promising CAR-T candidate to the companys existing portfolio.[47] In November, the company announced it will acquire Cell Design Labs for up to $567 million, after it indirectly acquired a stake of 12.2% via the Kite Pharma deal.[48]

On May 9, 2019, the U.S. Department of Health and Human Services announced that Gilead Sciences will donate Truvada, the only drug approved to prevent infection with H.I.V., for free to 200,000 patients annually for 11 years.[49] On December 3, 2019, HHS explained how the government would distribute the donated drugs. HHS Secretary Alex Azar explained that the U.S. government will pay Gilead $200 per bottle for 30 pills for costs associated with getting the drug from factories into the eventual hands of patients.[50]

In March 2020, the company announced it would acquire Forty Seven Inc. for $95.50 a share ($4.9 billion in total).[51][52][53] On April 7, 2020, Gilead completed acquisition of Forty Seven, Inc. for "$95.50 per share, net to the seller in cash, without interest, or approximately $4.9 billion in the aggregate."[54][55]

In June 2020, Bloomberg reported that AstraZeneca Plc had made a preliminary approach to Gilead for a potential merger, worth almost $240 billion.[56][57][58] In the same month, the company announced it would acquire a 49.9% stake in privately held Pionyr Immunotherapeutics Inc for $275 million.[59]

Sovaldi and Harvoni

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".[60] Deutsche Bank estimated Sovaldi sales in the year's final quarter would be $53 million,[61] and Barron's noted the FDA approval and subsequent strong sales of the "potentially revolutionary" drug as a positive indicator for the stock.[62]

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.[63] 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.[64] 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.[65]

Gilead later combined Sovaldi with other antivirals in single-pill combinations. First, Sovaldi was combined with ledipasvir and marketed as Harvoni. This treatment for hepatitis C cures the patient in 94% to 99% of cases (HCV genotype 1).[66] 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.[67] Later single-pill combinations were Epclusa (with velpatasvir) and Vosevi (with velpatasvir and voxilaprevir).

Finances

For the fiscal year 2017, Gilead Sciences reported earnings of US$4.628 billion and annual revenue of US$26.107 billion,[1] a decline of 14.1% over the previous fiscal cycle. Gilead Sciences's shares traded at over $70 per share, and its market capitalization was valued at US$93.4 billion in October 2018.[68]

Year Revenue
in mil. USD$		 Net income
in mil. USD$		 Total assets
in mil. USD$		 Price per share
in USD$		 Employees
2005 2,028 814 3,766 9.77
2006 3,026 −1,190 4,086 14.31
2007 4,230 1,585 5,835 18.30
2008 5,336 1,979 6,937 22.74
2009 7,011 2,636 9,699 21.32
2010 7,949 2,901 11,593 18.15
2011 8,385 2,804 17,303 18.46
2012 9,702 2,592 21,240 26.13
2013 11,202 3,075 22,579 51.83 6,000
2014 24,890 12,101 34,664 82.82 7,000
2015 32,639[1] 18,108[1] 51,716[1] 98.83 8,000
2016 30,390[1] 13,501[1] 56,977[1] 78.87 9,000
2017 26,107[1] 4,628[1] 70,283[1] 70.13 10,000
2018 22,127[1] 5,455[1] 63,675[1] 63.86 11,000[69]
2019 22,449[1] 5,386[1] 61,627[1] 11,800[1]

Prospects for the future

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. Gilead benefited 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.[70] 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.[71] Gilead would benefit from proposals to let companies repatriate offshore capital with minimal further taxation.[72]

Gilead's Entospletinib has shown a 90% complete response rate for MLL type AML.[73]

Tax structures

On December 26, 2018, The Times reported that Gilead had used the Double Irish arrangement to avoid U.S. corporate taxes on non–U.S. profits, reporting that "A US pharmaceutical firm used a controversial tax loophole arrangement to shift almost €20 billion in profits through an Irish entity in just two years".[74]

Acquisition history
Illustration of the company's mergers, acquisitions and historical predecessors

Gilead Sciences

  
 

NeXstar Pharmaceuticals
(Acq 1999)

  
 
  
 

Triangle Pharmaceuticals
(Acq 2003)

  
 
  
 

Myogen, Inc.
(Acq 2006)

  
 
  
 

Corus Pharma, Inc
(Acq 2006)

  
 
  
 

Raylo Chemicals
(Acq 2006)

  
 
  
 

CV Therapeutics, Inc.
(Acq 2009)

  
 
  
 

CGI Pharmaceuticals
(Acq 2010)

  
 
  
 

Calistoga Pharmaceuticals (Acq 2011)

  
 
  
 

Pharmasset Inc
(Acq 2011)

  
 
  
 

Phenex Pharmaceuticals
(Acq 2015)

  
 
  
 

EpiTherapeutics
(Acq 2015)

  
 
  
 

Galapagos NV
(Acq 2015)

  
 
  
 

Nimbus Apollo, Inc.
(Acq 2016)

  
 
  
 

Kite Pharma
(Acq 2017)

  
 
  
 

Cell Design Labs
(Acq 2017)

  
 
Gilead Sciences
 

Criticism

Several class-action lawsuits have been filed against Gilead over allegations that the company deliberately delayed development of antiretroviral drugs based on tenofovir alafenamide fumarate (TAF) in order to maximize profits from previous-generation medications containing tenofovir disoproxil fumarate (TDF).[75] Plaintiffs allege that Gilead suspended TAF in 2004 despite clear evidence indicating that TAF-based medications were safer than TDF, a compound whose long-term use was associated with adverse side effects such as nephrotoxicity and bone density loss.[76][77] Gilead intentionally withheld results of clinical trials demonstrating TAF's relative safety and efficacy and shelved TAF-based therapies until 2010, when the Food and Drug Administration approved Gilead's application to patent TAF.[78] Gilead's first TAF medication, marketed under the trade name Genvoya, came out in 2015. In the interim period, many HIV patients who continuously took Gilead's older TDF-based drugs suffered permanent, debilitating kidney and bone damage, often developing conditions such as Fanconi syndrome and osteomalacia.[79]

Gilead has come under intense criticism for its high pricing of its patented drug sofosbuvir. In the US, for instance, it was launched at $1,000 per pill or $84,000 for the standard 84-day course.[80][81]

Gilead has also tried to eliminate competition in lucrative markets by entering voluntary licensing agreements (VLA) with companies from developing countries such as India, which mandated the limitation of the latter's operations to less lucrative markets. The company has also been criticized for creating harsh restrictions within countries where they have been denied rights, or are engaged in VLAs. For example, in India, they tried to create an 'anti-diversion' program to determine who could buy the drug, which was considered a coercive and policing move by Médecins Sans Frontières since it could lead to the exclusion of vulnerable groups like refugees and migrants from accessing the medicines.[82]

On January 21, 2020, the Wuhan Institute of Virology applied for a Chinese "use patent" on remdesivir, for the novel use of treating COVID-19.[83]

Gilead sought and obtained orphan drug designation for remdesivir from the US Food and Drug Administration (FDA) on March 23, 2020.[84] This designation is intended to encourage the development of drugs affecting fewer than 200,000 Americans by granting strengthened and extended legal monopoly rights to the manufacturer, along with waivers on taxes and government fees.[85][86] Remdesivir is a candidate for treating COVID-19; at the time the status was granted, fewer than 200,000 Americans had COVID-19, but numbers were climbing rapidly as the COVID-19 pandemic reached the US, and crossing the threshold soon was considered inevitable.[85][86] Remdesivir was developed by Gilead with over $79 million in U.S. government funding.[86] After facing strong reactions, Gilead gave up the "orphan drug" status for remdesivir on March 25.[87] Gilead retains 20-year remdesivir patents in more than 70 countries.[88]

Gilead has also been accused of price-gouging on other medications developed with public funding, including AIDS PrEP drug Tenofovir and hepatitis C drug sofosbuvir as well as Remdesivir.[89]

Remdesivir for treatment of patients with coronavirus

In June 2020, Gilead announced that the price of remdesivir is set at US$390 per vial for governments of developed countries including the United States and US$520 for private insurance companies in the US.[90] The expected course of treatment is six vials over five days for a total cost of US$2,340.[90]

On June 29, 2020, it was announced that the United States Department of Health and Human Services (HHS) had agreed to buy 500,000 remdesivir treatment courses. Gilead was quoted in the announcement, in a section mentioning that each five-day course of remdesivir—for treatment of a patient with coronavirus—would cost at least USD $2,340.00.[91] HHS Secretary Alex Azar was quoted, having said (in a press release) that "To the extent possible, we want to ensure that any American patient who needs remdesivir can get it".[91]

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gollark: (it allows reconfiguring the server URL)
gollark: Disregarding its responses, you'd be able to probably switch skynet to use EXT's backend with no code changes.
gollark: The protocols *are* 90% compatible, though, honestly.
gollark: ... as if.

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    Early last month, the Food and Drug Administration issued an emergency authorization for remdesivir to be used in cases of COVID-19 when patients were "hospitalized with severe disease," shortly after the drug showed "clear-cut positive effect" in a US trial. [...]

    "To the extent possible, we want to ensure that any American patient who needs remdesivir can get it," HHS Secretary Alex Azar said in a release.

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