 | |
 Headquarters in Foster City | |
| Company type | Public |
|---|---|
| |
| Industry | |
| Founded | June 22, 1987; 38 years ago (1987-06-22) |
| Founder | Michael L. Riordan |
| Headquarters | Foster City, California, United States |
Area served | Worldwide |
Key people |
|
| Products | |
| Revenue |  US$28.75 billion (2024) |
 US$1.662 billion (2024) | |
| US$480 million (2024) | |
| Total assets | US$58.99 billion (2024) |
| Total equity | US$19.25 billion (2024) |
Number of employees | 17,600 (2024) |
| Website | gilead |
| Footnotes / references [1] | |
Gilead Sciences, Inc. (/ˈɡɪliəd/) is an Americanbiopharmaceutical company headquartered inFoster City, California, that focuses on researching and developingantiviral drugs used in the treatment ofHIV/AIDS,hepatitis B,hepatitis C,influenza, andCOVID-19, includingledipasvir/sofosbuvir andsofosbuvir. Gilead is a member of theNasdaq-100 and theS&P 100.
Gilead was founded in 1987 under the name Oligogen by Michael L. Riordan. The original name was a reference tooligonucleotides, small strands of DNA used to target genetic sequences. Gilead held itsinitial public offering in 1992, and successfully developed drugs likeTamiflu andVistide that decade.
In the 2000s, Gilead received approval for drugs includingViread andHepsera, among others. It began evolving from a biotechnology company into a pharmaceutical company, acquiring several subsidiaries, though it still relied heavily on contracting to manufacture its drugs.
The company continued its growth in the 2010s. However, it came under heavy scrutiny over its business practices, including extremely high pricing of drugs such as Sovaldi and Truvada in the United States relative to production cost and cost in the developing world.[2][3][4][5][6]
| External videos | |
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 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 nameOligogen[7] by Michael L. Riordan, a medical doctor.[8] Riordan graduated fromWashington University in St. Louis, theJohns Hopkins School of Medicine, and theHarvard Business School.[9] The idea for Gilead began as a research project atMenlo Ventures, where Michael was an associate. Three scientific advisers worked with Riordan to create the company:Peter Dervan ofCaltech,Doug Melton ofHarvard, andHarold M. Weintraub of theFred Hutchinson Cancer Research Center, along with H. Dubose Montgomery, one of Menlo Ventures founders. Riordan served as CEO from the company's founding until 1996.[10][11]Menlo Ventures subsequently made the first investment in Gilead of $2 million.[12] Riordan also recruited scientific advisers, includingHarold Varmus, a Nobel laureate who later became Director of theNational Institutes of Health, andJack Szostak, recipient of the Nobel Prize for Physiology or Medicine in 2009.[13]
The company's primary therapeutic focus was in antiviral medicines, a field that piqued Riordan's interest after he contracteddengue fever.[14] Riordan recruitedDonald Rumsfeld to join the board of directors in 1988,[15] followed byBenno C. Schmidt, Sr.,[citation needed]Gordon Moore,[15] andGeorge P. Shultz.[15] Riordan tried to recruitWarren Buffett as an investor and board member but was unsuccessful.[8]
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 ofgene therapy.[7] According to Riordan, he had always wanted to use the name Gilead Sciences all along. Still, he used Oligogen as a temporary name because he needed to deal with a trademark clearance issue with a California nonprofit organization that was already using the word Gilead in its name.[16] He had first heard of theBalm of Gilead when he readLanford Wilson's playBalm in Gilead while in medical school, then learned that naturally occurring acetylsalicylic acid (aspirin) had been found in modern times in awillow tree species from that part of that world, and was therefore inspired to name his company Gilead.[16] After founding Oligogen, he contacted the nonprofit about the naming issue and secured the right to use the Gilead Sciences name in exchange for a $1,000 donation.[16]
By 1988, the company had moved its headquarters to Foster City's Vintage Park neighborhood, where it has been based ever since.[7] The company began to develop small molecule antiviral therapeutics in 1991, when the company in-licensed a group ofnucleotide compounds includingtenofovir.[8]
Riordan later recalled that Gilead's first decade as a startup was an extremely stressful experience for him, as a young venture capitalist serving for the first time as the founder, chairman, and chief executive officer of his own biotech company.[17] The new company had no products and very little income, and narrowly escaped going out of business on several occasions: "It was touch and go for a long time".[17] Finding a way for Gilead to make money was Riordan's top priority "every second of the day for eight years".[17]
Gilead's antisense intellectual property portfolio was sold toIonis Pharmaceuticals. Gilead debuted on theNASDAQ in January 1992.[18] Itsinitial public offering raised $86.25 million in proceeds.[18]
In June 1996, Gilead launched Vistide (cidofovir injection) for the treatment ofcytomegalovirus (CMV)retinitis in patients withAIDS.[19]
In January 1997,Donald Rumsfeld was appointed chairman, but left the board in January 2001 when he was appointedUnited States Secretary of Defense duringGeorge W. Bush's first term as president.[20][21]
In March 1999, Gilead acquired NeXstar Pharmaceuticals ofBoulder, Colorado. At the time, NeXstar's annual sales of $130 million was three times Gilead's sales; it sold AmBisome, an injectable fungal treatment, andDaunoXome, anoncology drug taken byHIV patients. That same year,Roche announced FDA approval ofTamiflu (oseltamivir) for the treatment ofinfluenza.[22] Tamiflu was originally discovered by Gilead and licensed to Roche for late-phase development and marketing.[23]
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.[24] 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.[24]
Viread (tenofovir) achieved first approval in 2001 for the treatment of HIV.[25]
In 2002, Gilead changed its corporate strategy to focus exclusively on antivirals, and sold its cancer assets toOSI Pharmaceuticals for $200 million.[26]
In December 2002, Gilead and Triangle Pharmaceuticals announced that Gilead would acquire Triangle for around $464 million; Triangle's lead drug wasemtricitabine that was near FDA approval, and it had two other antivirals in its pipeline.[26][27] The company also announced its first full year of profitability. Later that year, Hepsera (adefovir) was approved for the treatment of chronichepatitis B, and Emtriva (emtricitabine) for the treatment of HIV.[citation needed]
During this era, Gilead completed its gradual evolution from a biotech startup into a pharmaceutical company.[7][15] TheSan 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."[7] 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.[15] 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 tocontract manufacturing organizations.[28]
In 2004, during theAvian 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 chiefDonald 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.[29]
In 2006, the company acquired Corus Pharma, Inc. for $365 million.[30] The acquisition of Corus signaled Gilead's entry into the respiratory arena. Corus was developing aztreonam lysine for the treatment of patients withcystic fibrosis who are infected withPseudomonas aeruginosa.[citation needed]
In July 2006, the U.S.Food and Drug Administration (FDA) approvedAtripla, a once a day single tablet regimen for HIV, combining Sustiva (efavirenz), aBristol-Myers Squibb product, and Truvada (emtricitabine andtenofovir disoproxil), a Gilead product.[31][32][33]
Gilead purchased Raylo Chemicals, Inc. in November 2006, for a price ofUS$133.3 million.[34] Raylo Chemical, based inEdmonton, Alberta, was a wholly owned subsidiary ofDegussa 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. Under an agreement withGlaxoSmithKline, Myogen marketedFlolan (epoprostenol sodium) in the United States for the treatment ofprimary pulmonary hypertension. Additionally, Myogen was developing (in Phase 3 studies) darusentan,[35] also an endothelin receptor antagonist, for the potential treatment of resistanthypertension.
Gilead expanded its move into respiratory therapeutics in 2007 by entering into a licensing agreement with Parion for anepithelial sodium channel inhibitor for the treatment of pulmonary diseases, including cystic fibrosis,chronic obstructive pulmonary disease andbronchiectasis.[36]
In 2009, the company acquired CV Therapeutics, Inc. for $1.4 billion, bringing Ranexa and Lexiscan into Gilead.[37] 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.[37] Later that year, the company was named one of the Fastest Growing Companies byFortune.[38][39]
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.[40]
In February 2011, the company acquired Calistoga Pharmaceuticals forUS$375 million ($225 million plus milestone payments). The acquisition boosted Gilead's oncology and inflammation areas.[41][42] Later that year, Gilead made its most important acquisition – and by then most expensive – with theUS$10.4 billion purchase ofPharmasset, Inc. This transaction helped cement Gilead as the leader in treatment of thehepatitis C virus by giving it control ofsofosbuvir (see below).
In October 2011, Gilead broke ground on a massive multi-year expansion of its 17-building headquarters campus in Foster City.[43] 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.[43]
On July 16, 2012, the FDA approved Gilead'sTruvada 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.[44][45][46][47]
In 2013, the company acquiredYM Biosciences, Inc. for $510 million.[48] The acquisition brings drug candidateCYT387, an orally administered, once-daily, selective inhibitor of theJanus 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:
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 ofnon-alcoholic steatohepatitis and for the potential treatment ofhepatocellular carcinoma.[52][53] Also in 2016, the company was named the most generous company on the 2016Fortune list of The Most Generous Companies of theFortune 500. Charitable donations to HIV/AIDS and liver disease organizations totaled over 440 million in 2015.[54]
In August 2017, the company announced it would acquireKite Pharma for $11.9 billion,[55] equating to $180 cash per share, a 29% premium over the closing price of the shares. The deal was Gilead's entry into thecell therapy market and added a chimeric antigen receptor T cell (CAR-T) therapy candidate to the company's portfolio.[56] By 2022 this acquisition had led to two marketed products for lymphoma:Yescarta andTecartus.[57] 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.[58]
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.[59] On December 3, 2019, HHS explained how the government would distribute the donated drugs. HHS SecretaryAlex 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.[60]
In March 2020, the company announced it would acquireForty Seven Inc. for $95.50 a share ($4.9 billion in total).[61][62][63] 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."[64][65]
In June 2020,Bloomberg reported thatAstraZeneca Plc had made a preliminary approach to Gilead for a potential merger, worth almost $240 billion.[66][67][68] In the same month, the company announced it would acquire a 49.9% stake in privately held Pionyr Immunotherapeutics Inc for $275 million.[69]
In September 2020, Gilead announced it had reached a deal to acquireImmunomedics for $21 billion ($88 per share), gaining control of the cancer treatmentTrodelvy (Sacituzumab govitecan-hziy) – a first-in-classTrop-2 antibody-drug conjugate.[70][71][72] In December, the business announced it would acquire German biotech, MYR GmbH, for €1.15 billion plus up to a further €300 million. MYR focuses on the treatment of chronichepatitis delta virus.[73][74]
On August 11, 2021, U.S. SenatorRand Paul disclosed that his wifeKelley Paul had purchased a stake in Gilead Sciences on February 26, 2020.[75]
In November 2021, the company was added to theDow Jones Sustainability World Index.[76]
In January 2022, Gilead pulled its cancer drug Zydelig (idelalisib) from its accelerated approval in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL).[77] In September, the company completed its acquisition ofMiroBio for $405 million.[78]
In February 2023, the business, throughKite Pharma completed its acquisition of Tmunity Therapeutics[79] In May, the business announced it would acquire XinThera and its small molecule inhibitors.[80]
In February 2024, the company acquiredCymaBay Therapeutics,[81] and in September, paid Genesis Therapeutics $35 million for AI-based drug discovery work.[82]
In May 2025, Gilead Sciences announced it would pay $10 million for sole ownership of arenavirus immunotherapies for hepatitis B (HBV) and HIV resulting from the company's collaboration with Hookipa Pharma.[83]
The drugsofosbuvir 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 thehepatitis 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 ofPharmasset for $11 billion as "one of the best pharma acquisitions ever".[84]Deutsche Bank estimated Sovaldi sales in the year's final quarter would be $53 million,[85] andBarron's noted the FDA approval and subsequent strong sales of the "potentially revolutionary" drug as a positive indicator for the stock.[86]
On July 11, 2014, theUnited 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 chairmanRon Wyden (D-Oregon) and ranking minority memberChuck Grassley (R-Iowa) wrote to CEOJohn C. Martin asking Gilead to justify the price for this drug.[87] 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.[88] 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.[89]
Gilead later combined Sovaldi with other antivirals in single-pill combinations. First, Sovaldi was combined withledipasvir and marketed asHarvoni. This treatment for hepatitis C cures the patient in 94% to 99% of cases (HCV genotype 1).[90] 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.[91] Later single-pill combinations wereEpclusa (withvelpatasvir) andVosevi (withvelpatasvir andvoxilaprevir).
For the fiscal year 2017, Gilead Sciences reported earnings of US$4.628 billion and annual revenue of US$26.107 billion,[92] 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$93.4 billion in October 2018.[93]
| Year | Revenue in mil. USD$ | Net income in mil. USD$ | Total assets in mil. USD$ | Price per share in USD$ | Employees |
|---|---|---|---|---|---|
| 2005 | 2,028 | 814 | 3,766 | 9.77[citation needed] | |
| 2006 | 3,026 | −1,190 | 4,086 | 14.31[citation needed] | |
| 2007 | 4,230 | 1,585 | 5,835 | 18.30[citation needed] | |
| 2008 | 5,336 | 1,979 | 6,937 | 22.74[citation needed] | |
| 2009 | 7,011 | 2,636 | 9,699 | 21.32[citation needed] | |
| 2010 | 7,949 | 2,901 | 11,593 | 18.15[citation needed] | |
| 2011 | 8,385 | 2,804 | 17,303 | 18.46[citation needed] | |
| 2012 | 9,702 | 2,592 | 21,240 | 26.13[citation needed] | |
| 2013 | 11,202 | 3,075 | 22,579 | 51.83[citation needed] | 6,000[citation needed] |
| 2014 | 24,890 | 12,101 | 34,664 | 82.82[citation needed] | 7,000[citation needed] |
| 2015 | 32,639[92] | 18,108[92] | 51,716[92] | 98.83[citation needed] | 8,000[citation needed] |
| 2016 | 30,390[92] | 13,501[92] | 56,977[92] | 78.87[citation needed] | 9,000[citation needed] |
| 2017 | 26,107[92] | 4,628[92] | 70,283[92] | 70.13[citation needed] | 10,000[citation needed] |
| 2018 | 22,127[92] | 5,455[92] | 63,675[92] | 63.86[citation needed] | 11,000[94] |
| 2019 | 22,449[92] | 5,386[92] | 61,627[92] | 11,800[92] | |
| 2020 | 24,689[95] | 123[95] | 68,407[95] | 13,600 | |
| 2021 | 27,305[95] | 6,225[95] | 67,952[95] | 14,400[95] |
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 ofMedicaid in the ACA; Leerink analyst Geoffrey Porges wrote that Gilead's HIV drugs could face funding pressure under reform proposals.[96] 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.[97] Gilead would benefit from proposals to let companies repatriate offshore capital with minimal further taxation.[98]
Gilead'sEntospletinib has shown a 90% completeresponse rate for MLL typeacute myeloid leukaemia (AML).[99]
Several mass tort lawsuits[100] have been filed against Gilead alleging that the company deliberately delayed development of antiretroviral drugs based ontenofovir alafenamide fumarate (TAF) in order to maximize profits from previous-generation medications containingtenofovir disoproxil fumarate (TDF).[101] 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 asnephrotoxicity andbone density loss.[102][103]
Gilead's first TAF medication, marketed under the trade name Genvoya, came out in 2015. Lawsuits allege that in the interim period, many HIV patients who continuously took Gilead's older TDF-based drugs suffered severe side effects, includingnephrotoxicity.[104][105]
In 2023, the Institute for Clinical and Economic Review (ICER) identified Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) as one of five high-expenditure drugs that experienced significant net price increases without new clinical evidence to justify the hikes. Specifically, Biktarvy's wholesale acquisition cost rose by 5.49%, leading to an additional $815 million in costs to U.S. payers.[106]
Gilead came under intense criticism for its high pricing of its patented drugsofosbuvir (sold under the brand name Sovaldi), used to treathepatitis C.[2] In the US, for instance, it was launched at $1,000 per pill or $84,000 for the standard 84-day course,[3][107] but it was drastically cheaper in the developing world;[4] in India, it dropped as low as $4.29 per pill.[108] While Sovaldi represented a significant improvement over contemporary treatments, the controversy surrounding its price ignited a national debate in the US, according to Reuters.[109]
TheUnited States Senate Committee on Finance launched an 18-month investigation of Gilead's Sovaldi pricing, and argued in its 2015 report that Gilead set prices high in disregard of the human cost and in order to set the stage for a higher eventual price for Sovaldi's successor, Harvoni.[110][5] The committee's investigation, based in part on internal documents obtained from Gilead, revealed that the company had considered prices ranging from $50,000 to $115,000 per year, trying to strike a balance between revenue and predicted activist and public relations blowback, with little regard to research and development costs.[111]
The high prices forced stateMedicaid programs to ration treatment to patients, delaying treatment of less advanced hepatitis C cases.[111] In Oregon, for example, 10,000 Medicaid patients were deemed good candidates for Sovaldi therapy, but theOregon Health Authority estimated that treating half of these patients would more than double the state's total drug expenditures. The state thus opted to limit treatment to 500 patients per year.[111]
Truvada was introduced to the market by Gilead in 2004 to treat HIV infections.[6] In the following years, the United States government conducted research demonstrating that Truvada was able to prevent HIV infection. The USCenters for Disease Control holds the patent for this use of Truvada as pre-exposure prophylaxis (PreP).[6]
Gilead introduced Truvada for PreP in 2012, at which point a prescription cost approximately $1,200 per month in the United States.[112] By 2018, this price had increased to up to $2,000, despite generally costing less than $100 outside the U.S.[112] Gilead made over $3 billion in sales of Truvada in 2018.[6]
The high price drew the ire of activist groups such asACT UP and was the subject of a Congressional hearing in May 2019.[113] Gilead's CEO defended its pricing in the hearing by noting the large sums the company spends on HIV/AIDS research.[114] Activists pressured the US government to enforce its patent on Truvada in order to combat the high prices set by Gilead.[6]
In May 2019, Gilead announced it would donate enough Truvada to treat up to 200,000 patients annually for up to 11 years, the result of discussions with the Department of Health and Human Services under Trump. Dr.Rochelle Walensky noted that the donations still covered less than one-fifth of the people who need the drug, and argued it was possibly a move to help the company market Descovy, a more advanced successor drug.[115] Walensky led a 2020 study that concluded the high costs of Descovy would on the whole negate any comparative advantage of prescribing it over a generic Truvada alternative.[116][117]
In July 2021, Gilead announced it would decrease340B Drug Pricing Program reimbursements to clinics serving primarily low-income communities; clinics argued this severely hinders their ability to provide HIV/AIDS prevention and treatment services among vulnerable populations.[118]
Gilead has also been accused of stifling competition. A lawsuit filed in the United States in 2019 alleged that the company entered "pay for delay" agreements with other manufacturers, wherein the manufacturers agreed to delay releasing generic versions of Truvada.[119] In 2021,CVS Pharmacy andRite Aid filed a lawsuit on similar grounds against Gilead,Bristol-Myers Squibb, andTeva Pharmaceuticals in 2021.[120]
In response to criticisms over the price of Sovaldi, Gilead began licensing the rights to produce generic versions of the drug to select producers in India in 2015. Included in the licensing agreements were 'anti-diversion' provisions, designed to prevent the drug from being exported back to developed countries where the cheaper, generic alternatives were still unavailable.[121] (In India, a one-month treatment cost approximately US$300, versus $1,000 per pill in the United States.)[121] Gilead required the Indian producers to screen patients to determine who could buy Sovaldi, which was criticized byMédecins Sans Frontières since it could lead to the exclusion of vulnerable groups like refugees and migrants from accessing the medicines.[122] In response to the criticism, Gilead eventually relaxed these requirements.[121]
Gilead has been criticized fortax avoidance. Tax avoidance, as opposed totax evasion, is the use of legal means to shift tax burdens from the one jurisdiction to overseas affiliates that pay a lower tax rate, even if revenue is primarily generated outside the overseas jurisdiction.[citation needed]
A 2016 report by the liberal think tank Americans for Tax Fairness argued that Gilead was able to avoid up to $10 billion in taxes on U.S. sales through mechanisms such astransfer pricing,[123][124][125] the sale of assets between affiliated entities. In particular, Gilead sells intellectual property to an Irish subsidiary, which then sells the finished products, such as Sovaldi, in the United States and elsewhere, paying the low Irish tax rate on profits.[126] The practice is common among multinational pharmaceutical companies like Gilead.[123]
On December 26, 2018,The Times reported that Gilead had used theDouble Irish arrangement to avoid U.S. corporate taxes on global profits, stating that the firm "used a controversial tax loophole arrangement to shift almost€20 billion in profits through an Irish entity in just two years" without paying Irish taxes.[127] The company repatriated a portion of the Irish subsidiary's holdings, $28 billion, to the United States in 2018 following reductions of the corporate tax rate. For this it paid an estimated $5.5 billion in tax.[127]
Gilead sought and obtainedorphan drug designation forremdesivir from the USFood and Drug Administration (FDA) on March 23, 2020.[128] 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.[129]
Remdesivir became 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 theCOVID-19 pandemic reached the US, and crossing the threshold soon was considered inevitable.[129] Gilead retains 20-year remdesivir patents in more than 70 countries.[130]
In 2021, remdesivir (tradenameVeklury) generated more than $4.5 billion in annual revenues, and was Gilead's highest selling product.[131][132]
Emergency use authorization for remdesivir was granted in the U.S. on May 1, 2020, for people hospitalized with severe COVID-19.[133] In September 2020 following a review of the evidence, the WHO issued guidance not to use remdesivir for people with COVID-19, as there was no good evidence of benefit.[134] However, over 2020–22 with furtherclinical research, remdesivir had been approved for treatment of hospitalized people with COVID-19 in the United States, European Union, and multiple other countries.[135][136][137] In 2022, the Canadian component of the WHO internationalSolidarity Trial reported that in-hospital people with COVID-19 treated with remdesivir had lower death rates (by about 4%) and reduced need for oxygen and mechanical ventilation compared to people receiving standard-of-care treatments.[138]
Veklury received approval from the USFood and Drug Administration (FDA) in October 2020 use in hospitalized adults and children 12 years and older for treatment of severe COVID-19 infections.[139] In January 2022, the FDA gave regulatory approval toVeklury for use in adults and children (12 years of age and older who weigh at least 40 kilograms (88 lb) and are positive for COVID-19, not hospitalized, and are ill having high risk for developing severe COVID-19, including hospitalization or death.[140]
The FDA also providedEmergency Use Authorization forVeklury treatment of children under age 12 who are COVID-positive and not hospitalized, but have mild-to-moderate COVID-19 with high risk of developing severe COVID-19, including hospitalization or death.[140]
Public outrage over the cost of Sovaldi in 2013 - despite that it was a vast improvement over existing equally expensive therapies - ignited a national debate on fair pricing for prescription medicines that the pharmaceutical industry has fought to deflect ever since.
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