:Gilead Sciences

{{external media | width = 210px | float = right | headerimage=210px | video1 = Gregg Alton of Gilead Sciences & others, [https://vimeo.com/59281508 "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{{cite news |last1=Tansey |first1=Bernadette |title=Profile: Gilead Sciences / Gilead grows up / Visionary biotech startup matures into pragmatic industry leader |url=https://www.sfgate.com/business/article/PROFILE-Gilead-Sciences-Gilead-grows-up-2655081.php |page=E1 |access-date=March 21, 2020 |work=San Francisco Chronicle |publisher=Hearst Communications, Inc. |date=April 14, 2003}} by Michael L. Riordan, a medical doctor.{{Cite book|last=Boslaugh|first=Sarah E.|url=https://books.google.com/books?id=du8BCwAAQBAJ&pg=PA657 |title=The Sage Encyclopedia of Pharmacology and Society|date=2015|page=657|publisher=Sage Publications|isbn=978-1-4833-4999-2}} Riordan graduated from Washington University in St. Louis, the Johns Hopkins School of Medicine, and the Harvard Business School.{{cite web|title=1996 Alumni Achievement Awards|url=http://engineering.wustl.edu/alumniawards.aspx?year=1996|publisher=Washington University in St. Louis|archive-url=https://web.archive.org/web/20140821175910/http://engineering.wustl.edu/alumniawards.aspx?year=1996|archive-date=August 21, 2014}} The idea for Gilead began as a research project at Menlo Ventures, where Michael was an associate. 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, along with H. Dubose Montgomery, one of Menlo Ventures founders. Riordan served as CEO from the company's founding until 1996.{{Cite news|url=https://www.forbes.com/global/2003/1027/090.html#1c843b13753b|title=The Golden Age of Antiviral Drugs|last=Moukheiber|first=Kerry A. Dolan Zina|work=Forbes|access-date=December 14, 2017}}{{Cite web|url=https://www.scribd.com/document/109025550/Gilead-Sciences-Board-Resolution-Michael-Riordan-Founder-CEO-Chairman-Antiviral-Medicine-AIDS-Therapeutics-Nucleotides|title=Gilead Sciences Board Resolution Michael Riordan Founder CEO Chairman Antiviral Medicine AIDS Therapeutics Nucleotides |website=Scribd|access-date=December 14, 2017}} Menlo Ventures subsequently made the first investment in Gilead of $2 million.{{cite web|url=http://www.fundinguniverse.com/company-histories/gilead-sciences-inc-history/|title=History of Gilead Sciences, Inc. – FundingUniverse|work=fundinguniverse.com}} 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.{{Cite web|url=https://www.nih.gov/about-nih/what-we-do/nih-almanac/harold-e-varmus-md|title=Harold E. Varmus, M.D.|date=August 6, 2015|website=National Institutes of Health (NIH)|access-date=February 25, 2019}}

The company's primary therapeutic focus was in antiviral medicines, a field that piqued Riordan's interest after he contracted dengue fever.{{cite news|last1=Moukheiber|first1=Zina|last2=Dolan|first2=Kerry A.|title=The Golden Age of Antiviral Drugs|url=https://www.forbes.com/global/2003/1027/090.html|work=Forbes|date=October 27, 2003}} Riordan recruited Donald Rumsfeld to join the board of directors in 1988,{{cite news |last1=Jacobs |first1=Paul |title=Gilead Gets Well – Tough Medicine Works At Biotech Firm |work=San Jose Mercury News |publisher=Knight Ridder |date=April 5, 2004 |location=San Jose |page=1F}} Available through NewsBank. followed by Benno C. Schmidt, Sr.,{{citation needed|date=April 2020}} Gordon Moore, and George P. Shultz. Riordan tried to recruit Warren Buffett as an investor and board member but was unsuccessful.

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. 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.{{cite book |last1=Elbe |first1=Stephan |title=Pandemics, Pills, and Politics: Governing Global Health Security |date=2018 |publisher=Johns Hopkins University Press |location=Baltimore |isbn=9781421425580 |page=57 |url=https://books.google.com/books?id=hYxaDwAAQBAJ&pg=PA57 |access-date=February 4, 2022}} He had first heard of the Balm of Gilead when he read Lanford Wilson's play Balm in Gilead while in medical school, then learned that naturally occurring acetylsalicylic acid (aspirin) had been found in modern times in a willow tree species from that part of that world, and was therefore inspired to name his company Gilead. 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.

By 1988, the company had moved its headquarters to Foster City's Vintage Park neighborhood, where it has been based ever since. The company began to develop small molecule antiviral therapeutics in 1991, when the company in-licensed a group of nucleotide compounds including tenofovir.

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.{{cite book |last1=Elbe |first1=Stephan |title=Pandemics, Pills, and Politics: Governing Global Health Security |date=2018 |publisher=Johns Hopkins University Press |location=Baltimore |isbn=9781421425580 |page=60 |url=https://books.google.com/books?id=hYxaDwAAQBAJ&pg=PA60 |access-date=February 4, 2022}} 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". Finding a way for Gilead to make money was Riordan's top priority "every second of the day for eight years".

Gilead's antisense intellectual property portfolio was sold to Ionis Pharmaceuticals. Gilead debuted on the NASDAQ in January 1992.{{Cite web |last=Thoelcke |first=Trey |date=9 December 2023 |title=12 Companies That Had IPOs in 1992: Best and Worst Performers |url=https://247wallst.com/investing/2023/12/09/12-companies-that-had-their-ipos-in-1992-best-and-worst-performers/ |access-date=6 November 2024 |website=247wallst.com}} 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.{{Cite news|last=Fisher|first=Lawrence M.|date=June 28, 1996|title=F.D.A. Approves Gilead's Drug for AIDS Patients|language=en-US|work=The New York Times|url=https://www.nytimes.com/1996/06/28/business/fda-approves-gilead-s-drug-for-aids-patients.html|access-date=September 22, 2021|issn=0362-4331}}

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.{{Cite web|url=https://www.ktvq.com/cnn-national/2019/06/27/donald-rumsfeld-fast-facts/|title=Donald Rumsfeld Fast Facts|date=June 27, 2019|website=KTVQ|access-date=April 3, 2020}}{{Cite web |last=McFadden |first=Robert D. |date=30 June 2021 |title=Donald H. Rumsfeld, Defense Secretary During Iraq War, Is Dead at 88 |url=https://www.nytimes.com/2021/06/30/us/politics/donald-rumsfeld-dead.html |access-date=23 October 2024 |website=The New York Times}}

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.{{Cite web|url=https://www.healio.com/infectious-disease/influenza/news/online/%7Bdd9e36ad-b85a-4f58-a843-1c542c771c70%7D/fda-approves-first-generic-of-tamiflu-for-influenza-a-b|title=FDA approves first generic of Tamiflu for influenza A, B|date=August 4, 2016|website=www.healio.com|access-date=April 3, 2020}} Tamiflu was originally discovered by Gilead and licensed to Roche for late-phase development and marketing.{{Cite web|date=November 17, 2005|title=Roche settles dispute with Gilead over Tamiflu|url=http://www.pharmatimes.com/news/roche_settles_dispute_with_gilead_over_tamiflu_997546|access-date=September 19, 2021|website=PharmaTimes|language=en}}

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.{{cite news |last1=Abate |first1=Tom |title=Gilead's Success, Pipeline Has Been a Balm for Biotech Investors – Foster City firm's shares have jumped 250% in past year |work=San Francisco Business Journal |publisher=American City Business Journals |date=August 23, 1999 |location=San Francisco |page=C1}} Available through NewsBank. 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.

Viread (tenofovir) achieved first approval in 2001 for the treatment of HIV.{{Cite journal|last1=Masho|first1=Saba Woldemichael|last2=Wang|first2=Cun-Lin|last3=Nixon|first3=Daniel E|date=December 2007|title=Review of tenofovir-emtricitabine|journal=Therapeutics and Clinical Risk Management|volume=3|issue=6|pages=1097–1104|issn=1176-6336|pmc=2387297|pmid=18516268}}

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

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.{{cite news|last1=Gellene|first1=Denise|title=Gilead Sciences to Buy Triangle Pharmaceuticals|url=https://www.latimes.com/archives/la-xpm-2002-dec-05-fi-gilead5-story.html|work=Los Angeles Times|date=December 5, 2002}}{{cite news|title=Gilead to Pay $464 Million For Triangle Pharmaceuticals|url=https://www.wsj.com/articles/SB1039013783682043153|work=Wall Street Journal|date=December 4, 2002}} 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.{{citation needed|date=October 2022}}

During this era, Gilead completed its gradual evolution from a biotech startup into a pharmaceutical company. 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." 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. 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.{{cite news |last1=Stanton |first1=Dan |title=Gilead's reliance on CMOs gives firm 'flexibility' says CFO |url=https://www.outsourcing-pharma.com/Article/2015/05/21/Gilead-s-reliance-on-CMOs-gives-firm-flexibility-says-CFO |access-date=April 1, 2020 |work=Outsourcing-Pharma.com|publisher=William Reed Business Media Ltd |date=May 20, 2015 |location=Crawley}}

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.{{Cite web|date=March 12, 2006|title=Donald Rumsfeld makes $5m killing on bird flu drug|url=http://www.independent.co.uk/news/world/americas/donald-rumsfeld-makes-5m-killing-on-bird-flu-drug-6106843.html|access-date=August 2, 2020|website=The Independent}}

In 2006, the company acquired Corus Pharma, Inc. for $365 million.{{Cite web |last=Staff |first=G. E. N. |date=2006-07-25 |title=Gilead Buys Corus Pharma for $365 million |url=https://www.genengnews.com/news/gilead-buys-corus-pharma-for-365-million/ |access-date=2024-09-27 |website=GEN - Genetic Engineering and Biotechnology News |language=en-US}} 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.{{citation needed|date=October 2022}}

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.{{cite news | last = Pollack | first = Andrew | title = F.D.A. Backs AIDS Pill to Be Taken Once a Day | work = The New York Times | date = July 13, 2006 | url = https://www.nytimes.com/2006/07/13/business/13drug.html | access-date = September 20, 2007 }}{{cite press release | title = U.S. Food And Drug Administration (FDA) Approves Atripla | publisher = Gilead Sciences and Bristol-Myers Squibb | date = July 12, 2006 | url = http://www.gilead.com/pr_881419 | access-date = December 15, 2007 | archive-url = https://web.archive.org/web/20081115000603/http://www.gilead.com/pr_881419 | archive-date = November 15, 2008 | url-status = dead }}{{cite press release | title=U.S. Food and Drug Administration (FDA) Approves Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen For Adults With HIV-1 Infection | publisher=Bristol-Myers Squibb and Gilead Sciences | via=Business Wire | date=July 12, 2006 | url=https://www.businesswire.com/news/home/20081211006202/en/U.S.-Food-Drug-Administration-FDA-Approves-ATRIPLA%E2%84%A2 | access-date=July 12, 2020}}

Gilead purchased Raylo Chemicals, Inc. in November 2006, for a price of {{US$|133.3 million}}.{{cite press release|title= Gilead Sciences Completes Acquisition of Raylo Chemicals Inc.|publisher= Gilead Sciences|date= November 3, 2006|url= http://www.gilead.com/wt/sec/pr_926645|access-date= June 7, 2007|archive-date= January 16, 2013|archive-url= https://web.archive.org/web/20130116053757/http://www.gilead.com/wt/sec/pr_926645|url-status= dead}} 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. 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,{{cite web |url=http://clinicaltrials.gov/ct/search?term=darusentan&submit=Search |title=ClinicalTrials.gov – Information on Clinical Trials and Human Research Studies: Darusentan |access-date=August 18, 2007}} also an endothelin receptor antagonist, for the potential treatment of resistant hypertension.

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.{{cite press release | title = Parion Sciences and Gilead Sciences Sign Agreement to Advance Drug Candidates for Pulmonary Disease | publisher = Gilead Sciences | date = August 15, 2007 | url = http://www.gilead.com/pr_1040975 | access-date = August 15, 2007 | archive-date = February 8, 2013 | archive-url = https://web.archive.org/web/20130208095740/http://www.gilead.com/pr_1040975 | url-status = dead }}

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.{{cite news | title=Gilead to Buy CV Therapeutics for $1.4 Billion | website=The New York Times | date=March 12, 2009 | url=https://www.nytimes.com/2009/03/13/business/13biotech.html | access-date=April 25, 2020 | agency=Reuters }} Later that year, the company was named one of the Fastest Growing Companies by Fortune.{{Cite web|url=https://money.cnn.com/magazines/fortune/fortunefastestgrowing/2009/full_list/|title=Fortune 100 Fastest-Growing Companies 2009|website=Fortune|access-date=April 13, 2020}}{{Cite web|url=https://www.cnbc.com/id/32389767|title=Fortune 100 Fastest-Growing Companies|date=August 17, 2009|website=CNBC|access-date=April 13, 2020}}

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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.{{cite press release | title = Gilead Sciences to Acquire Arresto Biosciences for $225 Million; Deal Adds Pipeline Candidates for Fibrotic Diseases | publisher = Gilead Sciences | url = http://www.gilead.com/pr_1509319 | date = December 20, 2010 | access-date = January 15, 2011 | archive-url = https://web.archive.org/web/20110113094502/http://www.gilead.com/pr_1509319 | archive-date = January 13, 2011 | url-status = dead }}

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.{{cite press release | title = Gilead Sciences to Acquire Calistoga Pharmaceuticals for $375 Million; Deal Adds Pipeline Candidates in Oncology and Inflammation | publisher = Gilead Sciences | url = http://investors.gilead.com/preview/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1531190&highlight= | archive-url = https://archive.today/20120709051240/http://investors.gilead.com/preview/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1531190&highlight= | url-status = dead | archive-date = July 9, 2012 | date = February 22, 2011 | access-date = February 22, 2011 }}{{cite press release | title=Gilead Sciences to Acquire Calistoga Pharmaceuticals for $375 Million | website=Gilead Sciences, Inc. | date=February 22, 2011 | url=https://www.gilead.com/news-and-press/press-room/press-releases/2011/2/gilead-sciences-to-acquire-calistoga-pharmaceuticals-for-$375-million | access-date=July 12, 2020}} Later that year, Gilead made its most important acquisition – and by then most expensive – with the {{US$|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.{{cite news |last1=Leuty |first1=Ron |title=Gilead breaking ground on 1st part of massive campus rebuild in Foster City |url=https://www.bizjournals.com/sanfrancisco/blog/biotech/2011/10/gilead-expansion-building.html |access-date=March 21, 2020 |work=San Francisco Business Journal |publisher=American City Business Journals |date=October 19, 2011}} 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.

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.{{cite web|last=Perrone|first=Matthew|title=FDA approves first pill to help prevent HIV|url=http://today.msnbc.msn.com/id/48198452/ns/today-today_health/t/fda-approves-first-pill-help-prevent-hiv/ |archive-url=https://web.archive.org/web/20120716220630/http://today.msnbc.msn.com/id/48198452/ns/today-today_health/t/fda-approves-first-pill-help-prevent-hiv/ |url-status=dead|archive-date=July 16, 2012|work=Today Health|publisher=NBC News|access-date=July 16, 2012}}{{cite web | title=Drug Approval Package: Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) NDA #021752 | website=U.S. Food and Drug Administration | date=January 31, 2006 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021752s000_TruvadaTOC.cfm | access-date=July 12, 2020}}{{cite press release | title=FDA encourages ongoing education of HIV PrEP treatment | website=U.S. Food and Drug Administration | date=July 1, 2019 | url=https://www.fda.gov/news-events/fda-brief/fda-brief-fda-continues-encourage-ongoing-education-about-benefits-and-risks-associated-prep | access-date=July 12, 2020}}{{cite press release | url=https://aidsinfo.nih.gov/news/1254/fda-approves-first-drug-for-reducing-the-risk-of-sexually-acquired-hiv-infection | title=FDA approves first drug for reducing the risk of sexually acquired HIV infection | date=July 16, 2012 | access-date=July 12, 2020}}

In 2013, the company acquired YM Biosciences, Inc. for $510 million.{{Cite web |title=Gilead Sciences Acquires YM Biosciences |url=https://www.lexpert.ca/big-deals/gilead-sciences-acquires-ym-biosciences/347742 |access-date=2024-10-23 |website=www.lexpert.ca |language=en}} 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.{{cite web|url=http://www.genengnews.com/gen-news-highlights/gilead-to-acquire-phenex-s-fxr-program-for-up-to-470m/81250770/|title=Gilead to Acquire Phenex's FXR Program for Up-to-$470M|work=Genetic Engineering and Biotechnology News: GEN}}
• 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.{{cite web|url=http://www.genengnews.com/gen-news-highlights/gilead-boosts-cancer-pipeline-with-65m-epitherapeutics-buy/81251237/|title=Gilead Boosts Cancer Pipeline With $65M EpiTherapeutics Buy|work=Genetic Engineering and Biotechnology News: GEN|date=May 6, 2015}}
• 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.{{cite web|title=Gilead (GILD) Collaborates with Galapagos for Filgotinib|url=https://finance.yahoo.com/news/gilead-gild-collaborates-galapagos-filgotinib-214009221.html|website=Yahoo Finance|date=December 18, 2015 |publisher=Yahoo/Zack's|access-date=December 31, 2015}}

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.{{Cite web|url=https://investors.gilead.com/news-releases/news-release-details/gilead-sciences-announces-acquisition-nimbus-therapeutics-acetyl|title=Gilead Sciences Announces Acquisition of Nimbus Therapeutics' Acetyl-CoA Carboxylase (ACC) Program for NASH and Other Liver Diseases | Gilead Sciences|website=investors.gilead.com|access-date=September 23, 2021|archive-date=September 23, 2021|archive-url=https://web.archive.org/web/20210923191142/https://investors.gilead.com/news-releases/news-release-details/gilead-sciences-announces-acquisition-nimbus-therapeutics-acetyl|url-status=dead}}{{cite web|url=http://www.parentherald.com/articles/35157/20160406/gilead-sciences-nimbus-drug-acquired-offering-cure-fatty-liver.htm|title=Gilead Sciences: Nimbus Drug Acquired, Offering Cure For Fatty Liver|work=Parent Herald|date=April 6, 2016}} 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.{{Cite news|url=http://fortune.com/2016/06/22/fortune-500-most-charitable-companies/|title=The Giving 20: The Most Generous Companies in America|work=Fortune|access-date=December 14, 2017}}

In August 2017, the company announced it would acquire Kite Pharma for $11.9 billion,{{cite news|url=https://www.reuters.com/article/uk-kite-pharma-m-a-gilead-sciences-idUKKCN1B810W|title=Gilead to buy Kite for promising cancer therapies in $12 billion deal|date=August 28, 2017|work=reuters.com}} equating to $180 cash per share, a 29% premium over the closing price of the shares. The deal was Gilead's entry into the cell therapy market and added a chimeric antigen receptor T cell (CAR-T) therapy candidate to the company's portfolio.{{cite web|url=http://www.fiercepharma.com/pharma/gilead-grabs-kite-for-11-9b-thrusting-itself-to-front-car-t-field |title=Growth-hungry Gilead finally pivots from flagging hep C with $12B Kite buy |website=fiercepharma.com |date=August 28, 2017 |access-date=August 29, 2017}} By 2022 this acquisition had led to two marketed products for lymphoma: Yescarta and Tecartus.{{Cite news |last=Bell |first=Jacob |date=9 December 2022 |title=Gilead buys into multiple myeloma cell therapy with Arcellx deal |work=BioPharma Dive |url=https://www.biopharmadive.com/news/gilead-arcellx-cell-therapy-deal-car-t/638427/ |access-date=10 December 2022}} 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.{{cite news |url=https://www.reuters.com/article/us-gilead-sciences-m-a-idUSKBN1E134T |url-access=subscription |archive-url=https://web.archive.org/web/20200606150639/https://www.reuters.com/article/us-gilead-sciences-m-a-idUSKBN1E134T/ |archive-date=6 June 2020 |title=Gilead to buy Cell Design Labs for up to $567 million|date=December 7, 2017|work=reuters.com}}{{cbignore}}

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.{{Cite news|url=https://www.nytimes.com/2019/05/09/health/gilead-truvada-hiv-aids.html|title=Gilead Will Donate Truvada to U.S. for H.I.V. Prevention|first=Donald G.|last=McNeil, Jr.|date=May 9, 2019|work=The New York Times|access-date=December 4, 2019|issn=0362-4331}} 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.{{Cite news|url=https://www.nytimes.com/2019/12/03/health/truvada-prep-hiv-gilead.html|title=200,000 Uninsured Americans to Get Free H.I.V.-Prevention Drugs|first=Donald G.|last= McNeil, Jr.|date=December 3, 2019|work=The New York Times|access-date=December 4, 2019|issn=0362-4331}}

In March 2020, the company announced it would acquire Forty Seven Inc. for $95.50 a share ($4.9 billion in total).{{Cite web|url=https://www.biospace.com/article/gilead-buys-forty-seven-for-4-9-billion/|title=Gilead to Acquire Immuno-Oncology Company Forty Seven for $4.9 Billion|website=BioSpace|date=March 2, 2020 }}{{Cite web|url=https://www.biospace.com/article/gilead-to-acquire-forty-seven-for-4-9-billion/|title=Gilead to Acquire Forty Seven for $4.9 Billion|website=BioSpace}}{{Cite news|url=https://www.reuters.com/article/us-forty-seven-m-a-gilead-sciences-idUKKBN20P1PX |url-access=subscription |archive-url=https://web.archive.org/web/20220327052348/http://reuters.com/article/us-forty-seven-m-a-gilead-sciences-idUKKBN20P1PX |archive-date=27 March 2022 |title=Gilead buys Forty Seven for $4.9 billion to bolster cancer drug pipeline|date=March 2, 2020|website=Reuters}}{{cbignore}} 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."{{Cite web|url=http://investors.gilead.com/news-releases/news-release-details/gilead-completes-acquisition-forty-seven-inc|title=Gilead Completes Acquisition of Forty Seven, Inc.|website=Gilead Sciences|access-date=April 11, 2020|archive-date=April 25, 2022|archive-url=https://web.archive.org/web/20220425130453/https://investors.gilead.com/news-releases/news-release-details/gilead-completes-acquisition-forty-seven-inc|url-status=dead}}{{Cite press release|url=https://www.businesswire.com/news/home/20200407005494/en/Gilead-Completes-Acquisition-Forty|title=Gilead Completes Acquisition of Forty Seven, Inc.|date=April 7, 2020|website=Gilead Sciences|via=Businesswire|access-date=April 11, 2020}}

In June 2020, Bloomberg reported that AstraZeneca Plc had made a preliminary approach to Gilead for a potential merger, worth almost $240 billion.{{Cite web|first1=Ed|last1=Hammond|first2=Aaron|last2=Kirchfeld|first3=Dinesh|last3=Nair|date=June 7, 2020|title=A new pharma king? AstraZeneca approaches Gilead about potential merger: report|url=https://www.smh.com.au/business/companies/a-new-pharma-king-astrazeneca-approaches-gilead-about-potential-merger-report-20200608-p550d0.html|access-date=June 8, 2020|website=The Sydney Morning Herald}}{{Cite news|date=June 7, 2020|title=AstraZeneca Ponders a Huge $240 Billion Gilead Gamble|work=Bloomberg Law|url=https://www.bloomberg.com/opinion/articles/2020-06-07/astrazeneca-and-gilead-ponder-a-huge-240-billion-gamble|access-date=September 7, 2020}}{{Cite news|date=June 7, 2020|title=AstraZeneca Approaches Gilead About Potential Merger|work=Bloomberg News|url=https://www.bloomberg.com/news/articles/2020-06-07/astrazeneca-is-said-to-approach-gilead-about-potential-merger|access-date=September 7, 2020}} In the same month, the company announced it would acquire a 49.9% stake in privately held Pionyr Immunotherapeutics Inc for $275 million.{{Cite news|url=https://www.reuters.com/article/us-pionyr-m-a-gilead-sciences-idUKKBN23U1ZR|title=Gilead to buy 49.9% stake in cancer drug developer for $275 million|newspaper=Reuters |date=June 23, 2020|via=www.reuters.com}}

In September 2020, Gilead announced it had reached a deal to acquire Immunomedics for $21 billion ($88 per share), gaining control of the cancer treatment Trodelvy (Sacituzumab govitecan-hziy) – a first-in-class Trop-2 antibody-drug conjugate.{{Cite news|first1=Cara|last1=Lombardo|first2=Jonathan D.|last2=Rockoff|date=September 13, 2020|title=Gilead Reaches Deal to Buy Immunomedics for $21 Billion|work=Wall Street Journal|url=https://www.wsj.com/articles/gilead-nears-deal-to-buy-immunomedics-for-more-than-20-billion-11599936777|access-date=September 13, 2020|issn=0099-9660}}{{Cite web|url=https://www.gilead.com/news-and-press/press-room/press-releases/2020/9/gilead-sciences-to-acquire-immunomedics|title = Gilead Sciences to Acquire Immunomedics}}{{Cite web|url=https://www.biospace.com/article/gilead-sciences-moves-deeper-into-oncology-with-21-billion-acquisition-of-immunomedics/?s=79|title = Gilead Moves Deeper into Oncology with $21 Billion Acquisition of Immunomedics| date=September 14, 2020 }} 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 chronic hepatitis delta virus.{{Cite web|url=https://www.biospace.com/article/releases/gilead-sciences-to-acquire-myr-gmbh/?s=79|title = Gilead Sciences to Acquire MYR GMBH| date=December 10, 2020 }}{{Cite news|url=https://www.reuters.com/article/myr-m-a-gilead-idUKKBN28K1QC|title=Gilead to acquire German biotech firm MYR for about 1.15 billion euros|newspaper=Reuters|date=December 10, 2020|via=www.reuters.com}}

On August 11, 2021, U.S. Senator Rand Paul disclosed that his wife Kelley Paul had purchased a stake in Gilead Sciences on February 26, 2020.{{Cite news|last=Stanley-Becker|first=Isaac|date=August 12, 2021|title=Rand Paul discloses 16 months late that his wife bought stock in company behind covid treatment|language=en-US|newspaper=The Washington Post|url=https://www.washingtonpost.com/politics/2021/08/11/rand-paul-gilead-stock/|access-date=August 30, 2021|issn=0190-8286}}

In November 2021, the company was added to the Dow Jones Sustainability World Index.{{cite web | url=https://www.esgtoday.com/dow-jones-sustainability-indices-results-announced-alphabet-medtronic-are-in-nestle-totalenergies-out/ | title=Dow Jones Sustainability Indices Results Announced: Alphabet, Medtronic are in, Nestlé, TotalEnergies Out | date=November 15, 2021 }}

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).{{Cite web|title=Gilead Statement on Zydelig® U.S. Indication for Follicular Lymphoma and Small Lymphocytic Leukemia|url=https://www.gilead.com/news-and-press/company-statements/gilead-statement-on-zydelig-us-indication-for-follicular-lymphoma-and-small-lymphocytic-leukemia|access-date=February 7, 2022|website=www.gilead.com|language=en}} In September, the company completed its acquisition of MiroBio for $405 million.{{cite web | url=https://www.biospace.com/article/releases/gilead-sciences-completes-acquisition-of-mirobio/?s=79 | title=Gilead Sciences Completes Acquisition of MiroBio | date=September 20, 2022 }}

In February 2023, the business, through Kite Pharma completed its acquisition of Tmunity Therapeutics{{cite web | url=https://www.biospace.com/article/releases/kite-completes-acquisition-of-tmunity/?s=79 | title=Kite Completes Acquisition of Tmunity | date=February 22, 2023 }} In May, the business announced it would acquire XinThera and its small molecule inhibitors.{{cite web | url=https://www.biospace.com/article/releases/gilead-strengthens-early-pipeline-in-oncology-and-inflammation-through-the-acquisition-of-xinthera/?s=79 | title=Gilead Strengthens Early Pipeline in Oncology and Inflammation Through the Acquisition of XinThera | date=May 9, 2023 }}

In February 2024, the company acquired CymaBay Therapeutics,{{cite web | url=https://www.biospace.com/article/biospace-mergers-and-acquisitions-tracker/?s=79 | title=Novartis, Ono Latest to Announce Billion-Dollar M&A Deals | date=March 5, 2024 }} and in September, paid Genesis Therapeutics $35 million for AI-based drug discovery work.{{Cite web |last=Priyan |first=Vishnu |date=2024-09-11 |title=Gilead and Genesis partner to create novel therapies using AI |url=https://www.pharmaceutical-technology.com/news/gilead-genesis-partner-therapies-ai/ |access-date=2024-09-16 |website=Pharmaceutical Technology |language=en-US}}

{{hidden begin|border=1px #aaa solid|title=Gilead Sciences Acquisitions|ta1=center}}

{{Tree list}}

• 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)
• Tmunity Therapeutics (Acq 2023)
• Forty Seven (Acq 2020)
• Immunomedics (Acq 2020)
• MYR GmbH (Acq 2020)
• MiroBio (Acq 2022)
• CymaBay Therapeutics (Acq 2024)

{{Tree list/end}}

{{hidden end}}

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".{{cite news | url= https://www.forbes.com/sites/matthewherper/2013/12/31/grading-pharma-in-2013-16-drug-companies-ranked/ |title= Grading Pharma in 2013|work=Forbes |date=December 31, 2013 }} Deutsche Bank estimated Sovaldi sales in the year's final quarter would be $53 million,{{cite news | url= http://www.streetinsider.com/Analyst+Comments/Gilead+(GILD)+Q4+Sovaldi+Sales+Tracking+at+$53M+-+Deutsche+Bank/9020948.html |title= Q4 Sovaldi Sales Tracking at $53 Million |publisher=Street Insider |date=January 3, 2014 }} and Barron's noted the FDA approval and subsequent strong sales of the "potentially revolutionary" drug as a positive indicator for the stock.{{cite news | url= http://blogs.barrons.com/stockstowatchtoday/2014/01/02/gilead-sciences-sovaldi-to-boost-shares-in-2014-maxim-group-says/|title= Stocks to Watch |publisher=Barrons |date=January 2, 2014 }}

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.{{Cite news|title = Critics Raise Concerns About Sovaldi|url = https://www.nytimes.com/2014/08/03/upshot/is-a-1000-pill-really-too-much.html|newspaper = The New York Times|date = August 2, 2014|access-date = October 4, 2015|issn = 0362-4331|first = Margot|last = Sanger-Katz }} 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.{{cite web| url=http://seekingalpha.com/article/2880996-gilead-sciences-gild-ceo-john-martin-on-q4-2014-results-earnings-call-transcript?page=4|title=Gilead Q4 2014 Earnings Call|date=February 3, 2015 }} 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.{{Cite web |url=https://www.bloomberg.com/news/articles/2015-12-29/the-price-keeps-falling-for-a-superstar-gilead-drug-in-india |url-access=subscription |archive-url=https://web.archive.org/web/20151231193653/https://www.bloomberg.com/news/articles/2015-12-29/the-price-keeps-falling-for-a-superstar-gilead-drug-in-india |archive-date=31 December 2015 |title=The same pill that cost $1,000 in the U.S. sold for $4 in India |author=Ketaki Gokhale|publisher=Bloomberg News|date=December 28, 2015}}{{cbignore}}

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).{{cite journal |vauthors=Keating GM |title=Ledipasvir/Sofosbuvir: a review of its use in chronic hepatitis C |journal=Drugs |volume=75 |issue=6 |pages=675–85 |year=2015 |pmid=25837989 |doi=10.1007/s40265-015-0381-2 |s2cid=31943736 }} 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.{{Cite web|url=https://www.fool.com/investing/2017/03/09/i-was-wrong-about-gilead-sciences.aspx|title=I Was Wrong About Gilead Sciences|author=Michael Douglass|publisher=The Motley Fool|date=March 9, 2017}} Later single-pill combinations were Epclusa (with velpatasvir) and Vosevi (with velpatasvir and voxilaprevir).

For the fiscal year 2017, Gilead Sciences reported earnings of US$4.628 billion and annual revenue of US$26.107 billion,{{cite web |url=http://investors.gilead.com/static-files/1a607ba4-ee05-4dc5-9eeb-9509c6b8a3e4 |format=PDF |title=Gilead Sciences, Inc. 2019 Annual Report (Form 10-K) |date=February 2020 |publisher=Gilead Sciences |website=U.S. Securities and Exchange Commission |access-date=April 19, 2020 |archive-date=March 13, 2022 |archive-url=https://web.archive.org/web/20220313151512/https://investors.gilead.com/static-files/1a607ba4-ee05-4dc5-9eeb-9509c6b8a3e4 |url-status=dead }} 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.{{Cite web|url=https://www.macrotrends.net/stocks/charts/GILD/gilead-sciences/revenue|title=Gilead Sciences Revenue 2006–2018 |website=www.macrotrends.net|access-date=November 1, 2018}}

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.{{Cite news|url=http://www.investors.com/news/technology/will-gileads-hiv-franchise-plan-be-dashed-on-trumpcare/|title=Will Gilead's HIV Franchise Plan Be Dashed On TrumpCare?|author=Allison Gatlin|newspaper=Investor's Business Daily|publisher=Investors Business Daily|date=April 6, 2017}} 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.{{Cite web|url=http://blogs.barrons.com/stockstowatchtoday/2017/03/13/gilead-sciences-is-an-incyte-deal-reasonable/|title=Gilead Sciences: Is an Incyte Deal 'Reasonable'?|author=Ben Levisohn|publisher=Barron's|date=March 13, 2017}} Gilead would benefit from proposals to let companies repatriate offshore capital with minimal further taxation.{{Cite web|url=http://seekingalpha.com/article/4045199-pharma-m-2017-likely-deal-hunters|title=Pharma M&A In 2017: The Most Likely Deal Hunters|author=Ioannis Stamatopoulos|publisher=Seeking Alpha|date=February 12, 2017|access-date=March 12, 2017}}

Gilead's Entospletinib has shown a 90% complete response rate for MLL type acute myeloid leukaemia (AML).{{Cite journal|url=http://www.bloodjournal.org/content/128/22/2831?sso-checked=true |title=Interim Results of a Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination with Chemotherapy in Patients with Acute Myeloid Leukemia |author=Alison R. Walker|journal=Blood |publisher=Blood Journal|date=January 1, 2016|volume=128 |issue=22 |page=2831 |doi=10.1182/blood.V128.22.2831.2831 |doi-access=free }}

Several mass tort lawsuits{{cite web |last1=Jenner |first1=Rob |title="Morally Blameworthy" Gilead Under Fire in Legal Battle Over HIV Medication |url=https://www.jennerlawfirm.com/blog/morally-blameworthy-gilead-under-fire-in-legal-battle-over-hiv-medication/ |website=Jenner Law, Baltimore MD|date=January 12, 2024|access-date=January 12, 2024 |ref=51}} have been filed against Gilead alleging 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).{{cite web |last1=Petersen |first1=Melody |title=Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine |url=https://www.latimes.com/business/la-fi-gilead-hiv-drug-lawsuit-20180509-story.html |website=Los Angeles Times |date=May 5, 2018 |access-date=December 7, 2019 |ref=51}} 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.{{cite journal |last1=Tourret |first1=Jérôme |last2=Deray |first2=Gilbert |last3=Isnard-Bagnis |first3=Corinne |title=Tenofovir Effect on the Kidneys of HIV-Infected Patients: A Double-Edged Sword? |journal=Journal of the American Society of Nephrology |date=2013 |volume=24 |issue=10 |pages=1519–1527 |doi=10.1681/ASN.2012080857 |pmid=24052632 |pmc=3785270 }}{{cite journal |last1=Grigsby |first1=Iwen F. |last2=Pham |first2=Lan |last3=Mansky |first3=Louis M. |last4=Gopalakrishnan |first4=Raj |last5=Mansky |first5=Kim C. |title=Tenofovir-associated bone density loss |journal= Therapeutics and Clinical Risk Management|date=2010 |volume=6 |pages=41–47 |pmid=20169035 |pmc=2817787 }}

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, including nephrotoxicity.{{cite web |title=Gilead Lawsuits: 41 HIV and PrEP Patients File California Personal Injury Case Over Gilead's TDF-Based Drugs |url=https://www.businesswire.com/news/home/20190411005808/en/ |website=Business Wire |date=April 11, 2019 |access-date=December 7, 2019}}{{cite news |last1=Petersen |first1=Melody |title=Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine |url=https://www.latimes.com/business/la-fi-gilead-hiv-drug-lawsuit-20180509-story.html |access-date=March 11, 2022 |work=Los Angeles Times |date=May 9, 2018}}

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.{{Cite web |title=Institute for Clinical and Economic Review Announces Most Significant Drug-Price Hikes Unsupported by New Clinical Evidence in US |url=https://icer.org/news-insights/press-releases/icer-announces-most-significant-drug-price-hikes-unsupported-by-new-clinical-evidence-in-us/?mkt_tok=NjM4LVBYUi0zMTgAAAGYMxe5Fv3mzhJbiVnr0V4g2FUAcS3PgZOZSYRvQcW3_VFPXIet0TCD7bWAyVVeW2Q62e3AynO8rDpP8sIoIbs_qux8kQcMBBD4cDSe3Q |access-date=2025-02-06 |website=ICER |language=en-US}}

Gilead came under intense criticism for its high pricing of its patented drug sofosbuvir (sold under the brand name Sovaldi), used to treat hepatitis C.{{cite news |last1=Silverman |first1=Ed |title=Lawsuit Alleges Price Gouging by Maker of Hepatitis Drug |url=https://www.wsj.com/articles/lawsuit-alleges-price-gouging-by-maker-of-hepatitis-drug-1418961024 |access-date=September 19, 2021 |work=Wall Street Journal |date=December 19, 2014}} In the US, for instance, it was launched at $1,000 per pill or $84,000 for the standard 84-day course,{{cite web |last=Stanton |first=Tracy |name-list-style=vanc |title=Activists pounce on $1,000-a-day price for Gilead's hep C wonder drug, Sovaldi |url=http://www.fiercepharma.com/story/activists-pounce-1000-day-price-gileads-hep-c-wonder-drug-sovaldi/2013-12-09 |work=FiercePharma |access-date=February 22, 2014 |url-status=dead |archive-url=https://web.archive.org/web/20140218200421/http://www.fiercepharma.com/story/activists-pounce-1000-day-price-gileads-hep-c-wonder-drug-sovaldi/2013-12-09 |archive-date=February 18, 2014 }}{{cite web |last=Waldman |first=Ron | name-list-style = vanc |title=Gilead's HCV drug sofosbuvir approved by the FDA but accessible for how many?|url=http://doctorsoftheworld.org/wp-content/uploads/2013/07/Gileads-HCV-drug-sofosbuvir-approved-but-accessible-for-how-many-09DEC2013.pdf|publisher=Doctors of the World|access-date=February 22, 2014 |url-status=dead |archive-url=https://web.archive.org/web/20140226224657/http://doctorsoftheworld.org/wp-content/uploads/2013/07/Gileads-HCV-drug-sofosbuvir-approved-but-accessible-for-how-many-09DEC2013.pdf|archive-date=February 26, 2014 }} but it was drastically cheaper in the developing world;{{cite news |last1=Silverman |first1=Ed |title=Gilead Deal to Sell Sovaldi in Poor Countries Meets Criticism |url=https://www.wsj.com/articles/BL-270B-639 |access-date=September 19, 2021 |work=Wall Street Journal |date=September 15, 2014}} in India, it dropped as low as $4.29 per pill.{{cite news |last1=Gokhale |first1=Ketaki |title=The same pill that costs $1,000 in the U.S. sells for $4 in India |url=https://www.chicagotribune.com/business/ct-drug-price-sofosbuvir-sovaldi-india-us-20160104-story.html |access-date=September 19, 2021 |work=chicagotribune.com}} While Sovaldi represented a significant improvement over contemporary treatments, the controversy surrounding its price ignited a national debate in the US, according to Reuters.{{cite news |last1=Beasley |first1=Deena |title=Will Gilead price its coronavirus drug for public good or company profit? |url=https://www.reuters.com/article/us-health-coronavirus-gilead-pricing/will-gilead-price-its-coronavirus-drug-for-public-good-or-company-profit-idUSKBN22I2NM |access-date=September 19, 2021 |work=Reuters |date=May 6, 2020 |language=en |quote=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.}}

The United 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.{{cite news |last1=Sullivan |first1=Thomas |title=Senate Finance Committee Releases Results of Investigation Into Gilead's Pricing Strategy for Hepatitis-C Drugs |url=https://www.policymed.com/2015/12/senate-finance-committee-releases-results-of-investigation-into-gileads-pricing-strategy-for-hepatitis-c-drugs.html |work=Policy & Medicine |date=May 5, 2018}}{{cite news |title=Senate Report Criticizes Gilead's Pricing Strategy for Sovaldi |url=https://news.bloomberglaw.com/pharma-and-life-sciences/senate-report-criticizes-gileads-pricing-strategy-for-sovaldi |access-date=September 19, 2021 |work=Bloomberg Law |date=December 2, 2015 |language=en}} 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.{{cite news |last1=Johnson |first1=Carolyn Y. |last2=Dennis |first2=Brady |title=How an $84,000 drug got its price: 'Let's hold our position … whatever the headlines' |url=https://www.washingtonpost.com/news/wonk/wp/2015/12/01/how-an-84000-drug-got-its-price-lets-hold-our-position-whatever-the-headlines/ |access-date=September 19, 2021 |newspaper=Washington Post |date=December 1, 2015}}

The high prices forced state Medicaid programs to ration treatment to patients, delaying treatment of less advanced hepatitis C cases. In Oregon, for example, 10,000 Medicaid patients were deemed good candidates for Sovaldi therapy, but the Oregon 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.

Truvada was introduced to the market by Gilead in 2004 to treat HIV infections. In the following years, the United States government conducted research demonstrating that Truvada was able to prevent HIV infection. The US Centers for Disease Control holds the patent for this use of Truvada as pre-exposure prophylaxis (PreP).

Gilead introduced Truvada for PreP in 2012, at which point a prescription cost approximately $1,200 per month in the United States.{{cite news |last1=Fitzsimmons |first1=Tim |title=#BreakThePatent: How HIV activists are going after Gilead's PrEP patent |url=https://www.nbcnews.com/feature/nbc-out/breakthepatent-how-hiv-activists-are-going-after-gilead-s-prep-n892891 |access-date=September 19, 2021 |work=NBC News |date=July 19, 2018 |language=en}} By 2018, this price had increased to up to $2,000, despite generally costing less than $100 outside the U.S. Gilead made over $3 billion in sales of Truvada in 2018.{{cite news |last1=Rowland |first1=Christopher |title=An HIV treatment cost taxpayers millions. The government patented it. But a pharma giant is making billions. |url=https://www.washingtonpost.com/business/economy/pharma-giant-profits-from-hiv-treatment-funded-by-taxpayers-and-patented-by-the-government/2019/03/26/cee5afb4-40fc-11e9-9361-301ffb5bd5e6_story.html |newspaper=Washington Post |date=March 26, 2019}}

The high price drew the ire of activist groups such as ACT UP and was the subject of a Congressional hearing in May 2019.{{cite news |last1=Simmons-Duffin |first1=Selena |title=AIDS Activists Take Aim At Gilead To Lower Price Of HIV Drug PrEP |url=https://www.npr.org/sections/health-shots/2019/05/30/727731380/old-fight-new-front-aids-activists-want-lower-drug-prices-now |access-date=September 19, 2021 |work=NPR |date=May 30, 2019 |language=en}} Gilead's CEO defended its pricing in the hearing by noting the large sums the company spends on HIV/AIDS research.{{cite news |last1=Rowland |first1=Christopher |title=Gilead CEO insists federal government patent for HIV prevention pill Truvada is invalid |url=https://www.washingtonpost.com/business/economy/gilead-ceo-insists-federal-government-patent-for-hiv-prevention-pill-truvada-is-invalid/2019/05/16/7c0a79b6-77e1-11e9-b3f5-5673edf2d127_story.html |access-date=September 19, 2021 |newspaper=Washington Post |date=May 16, 2019}} Activists pressured the US government to enforce its patent on Truvada in order to combat the high prices set by Gilead.

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.{{cite news |last1=McNeil |first1=Donald G. |title=Gilead Will Donate Truvada to U.S. for H.I.V. Prevention |url=https://www.nytimes.com/2019/05/09/health/gilead-truvada-hiv-aids.html |access-date=September 20, 2021 |work=The New York Times |date=May 10, 2019}} 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.{{cite news |last1=Rapaport |first1=Lisa |title=New brand-name HIV-prevention pill not worth the added cost: study |url=https://www.reuters.com/article/us-health-prep-costs/new-brand-name-hiv-prevention-pill-not-worth-the-added-cost-study-idUSKBN20W31V |access-date=September 23, 2021 |work=Reuters |date=March 9, 2020 |language=en}}{{cite journal |last1=Walensky |first1=Rochelle P. |last2=Horn |first2=Tim |last3=McCann |first3=Nicole C. |last4=Freedberg |first4=Kenneth A. |last5=Paltiel |first5=A. David |title=Comparative Pricing of Branded Tenofovir Alafenamide–Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate–Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis |journal=Annals of Internal Medicine |date=May 5, 2020 |volume=172 |issue=9 |pages=583–590 |doi=10.7326/m19-3478|pmid=32150602 |pmc=7217721 }}

In July 2021, Gilead announced it would decrease 340B 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.{{cite news |last1=Ryan |first1=Benjamin |title=Pharma giant's policy change will devastate local HIV-prevention clinics' efforts |url=https://www.nbcnews.com/nbc-out/out-health-and-wellness/-will-shut-us-hiv-prevention-clinics-brace-gilead-reimbursement-cuts-rcna1346 |access-date=September 23, 2021 |work=NBC News |date=July 7, 2021 |language=en}}

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.{{cite news |last1=Rowland |first1=Christopher |title=Gilead is accused of cutting anti-competitive deals to extend profit on HIV drug combinations |url=https://www.washingtonpost.com/business/economy/gilead-is-accused-of-cutting-anti-competitive-deals-to-extend-profit-on-hiv-drug-cocktails/2019/05/14/94e79c56-75ad-11e9-bd25-c989555e7766_story.html |access-date=September 27, 2021 |newspaper=Washington Post |date=May 14, 2019}} In 2021, CVS Pharmacy and RiteAid filed a lawsuit on similar grounds against Gilead, Bristol-Myers Squibb, and Teva Pharmaceuticals in 2021.{{cite news |last1=Leuty |first1=Ron |title=Pharmacy chains sue Gilead for allegedly blocking lower-cost generic HIV drugs |url=https://www.bizjournals.com/sanjose/news/2021/09/23/cvs-rite-aid-accuse-gilead-of-blocking-hiv-drugs.html |access-date=September 27, 2021 |work=San Francisco Business Times |date=September 23, 2021}}

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.{{cite news |last1=Kazmin |first1=Amy |title=Pharma combats diversion of cheap drugs |url=https://www.ft.com/content/ce7f059a-d86c-11e4-8a68-00144feab7de |access-date=September 27, 2021 |work=Financial Times |date=April 12, 2015}} (In India, a one-month treatment cost approximately US$300, versus $1,000 per pill in the United States.) Gilead required the Indian producers to screen patients to determine who could buy Sovaldi, which was criticized by Médecins Sans Frontières since it could lead to the exclusion of vulnerable groups like refugees and migrants from accessing the medicines.{{Cite web|url=https://caravanmagazine.in/reportage/drug-deals|title=How big pharma and the Indian government are letting millions of patients down|last1=Gahlot|first1=Mandakini|last2=Krishnan|first2=Vidya|website=The Caravan|access-date=July 25, 2019}} In response to the criticism, Gilead eventually relaxed these requirements.

Gilead has been criticized for tax avoidance. Tax avoidance, as opposed to tax 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|date=October 2022}}

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 as transfer pricing,{{Cite news |last1=Merle |first1=Renae |last2=Johnson |first2=Carolyn Y. |title=The drug company that shocked the world with its prices dodged $10 billion in taxes, report says |language=en-US |newspaper=The Washington Post |url=https://www.washingtonpost.com/news/wonk/wp/2016/07/13/maker-of-84000-drug-avoided-10-billion-in-u-s-taxes-report-says/ |access-date=January 2, 2022 |issn=0190-8286}}{{Cite news |last=Silverman |first=Ed |date=July 13, 2016 |title=Gilead avoided nearly $10 billion in taxes last year thanks to tax dodges |language=en-US |work=Stat News |url=https://www.statnews.com/pharmalot/2016/07/13/gilead-hepatitis-c-taxes/ |access-date=January 2, 2022}}{{cite news |last1=Kocieniewski |first1=David |title=Gilead Seen Cutting Taxes by $10 Billion as Pricey Drug Took Off |url=https://www.bloomberg.com/news/articles/2016-07-13/gilead-seen-cutting-taxes-by-10-billion-as-pricey-drug-took-off |access-date=January 4, 2022 |work=Bloomberg News |date=July 13, 2016}} 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.{{cite journal |last1=Blair-Stanek |first1=Andrew |title=Just Compensation as Transfer Prices |journal=Arizona Law Review |date=2016 |volume=58 |issue=4 |pages=1093–94 |url=https://arizonalawreview.org/just-compensation-as-transfer-prices/ |access-date=January 4, 2022}} The practice is common among multinational pharmaceutical companies like Gilead.

On December 26, 2018, The Times reported that Gilead had used the Double Irish arrangement to avoid U.S. corporate taxes on global profits, stating that the firm "used a controversial tax loophole arrangement to shift almost {{Euro|20 billion}} in profits through an Irish entity in just two years" without paying Irish taxes.{{cite news|url=https://www.thetimes.com/world/us-world/article/us-pharma-giant-gilead-uses-double-irish-tax-loophole-j9gq5rdb7|title=US pharma giant Gilead uses 'Double Irish' tax loophole|work=The Times|location=London|author=Paul O'Donoghue|date=December 26, 2018}} 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.

Gilead sought and obtained orphan drug designation for remdesivir from the US Food and Drug Administration (FDA) on March 23, 2020.{{cite web | title=Remdesivir Orphan Drug Designations and Approvals | publisher=U.S. Food and Drug Administration (FDA) | url=https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=739020 | access-date=June 29, 2020}} 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.{{cite news |last1=Lupkin |first1=Sydney |title=FDA Grants Experimental Coronavirus Drug Benefits For Rare Disease Treatments |url=https://www.npr.org/sections/health-shots/2020/03/24/821035311/fda-grants-experimental-coronavirus-drug-benefits-for-rare-disease-treatments |access-date=March 24, 2020 |work=NPR |date=March 24, 2020}}

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 the COVID-19 pandemic reached the US, and crossing the threshold soon was considered inevitable. Gilead retains 20-year remdesivir patents in more than 70 countries.{{cite web |title=No profiteering on COVID-19 drugs and vaccines, says MSF |url=https://www.msf.org/no-profiteering-covid-19-drugs-and-vaccines-says-msf |website=Médecins Sans Frontières (MSF) International }}

In 2021, remdesivir (tradename Veklury) generated more than $4.5 billion in annual revenues, and was Gilead's highest selling product.{{cite news |author1=Dulan Lokuwithana |title=Gilead lifts 2021 guidance as remdesivir sales more than double in Q3 |url=https://seekingalpha.com/news/3760413-gilead-sciences-lifts-2021-guidance-as-remdesivir-sales-more-than-double-in-q3 |access-date=January 25, 2022 |work=Seeking Alpha |date=October 28, 2021}}{{cite news |author1=Kevin Dunleavy |title=Resurgent Veklury delivers Gilead $1.9B in sales and an earnings surprise |url=https://www.fiercepharma.com/pharma/resurgeant-veklury-delivers-gilead-1-9-billion-sales-and-earnings-surprise |access-date=January 25, 2022 |work=Fierce Pharma |date=October 29, 2021}}

Emergency use authorization for remdesivir was granted in the U.S. on May 1, 2020, for people hospitalized with severe COVID-19.{{cite journal | last1=Rizk | first1=John G. | last2=Forthal | first2=Donald N. | last3=Kalantar-Zadeh | first3=Kamyar | last4=Mehra | first4=Mandeep R. | last5=Lavie | first5=Carl J. | last6=Rizk | first6=Youssef | last7=Pfeiffer | first7=JoAnn P. | last8=Lewin | first8=John C. | title=Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic. | journal=Drug Discovery Today| volume=26 | issue=2 | year=2021 | issn=1359-6446 | pmid=33253920 | pmc=7694556 | doi=10.1016/j.drudis.2020.11.025 | pages=593–603}} 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.{{cite journal |vauthors=Lamontagne F, Agoritsas T, Macdonald H, Leo YS et al. |title=A living WHO guideline on drugs for covid-19 |journal=BMJ |volume=370 |pages=m3379 |date=September 2020 |pmid=32887691 |doi=10.1136/bmj.m3379 |s2cid=221498813 |doi-access=free }} However, over 2020–22 with further clinical research, remdesivir had been approved for treatment of hospitalized people with COVID-19 in the United States, European Union, and multiple other countries.{{cite web |title=Veklury becomes first option for COVID-19 approved in EU |url=https://www.thepharmaletter.com/article/veklury-becomes-first-option-for-covid-19-approved-in-eu |publisher=The Pharma Letter |access-date=January 25, 2022 |date=March 7, 2020}}{{cite web |title=Veklury |url=https://www.ema.europa.eu/en/medicines/human/EPAR/veklury |publisher=European Medicines Agency |access-date=January 25, 2022 |date=December 22, 2021}}{{cite web |title=COVID-19 Treatments |url=https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/treatments.html |publisher=Government of Canada |access-date=January 25, 2022 |date=January 17, 2022}} In 2022, the Canadian component of the WHO international Solidarity 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.{{cite journal |vauthors=Ali K, Azher T, Baqi M, Binnie A et al.| title=Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial | journal=Canadian Medical Association Journal | date=January 2022 | volume=194 | issue=7 | pages=E242–E251 | doi=10.1503/cmaj.211698 |pmid=35045989 | pmc=8863204 }}

Veklury received approval from the US Food and Drug Administration (FDA) in October 2020 use in hospitalized adults and children 12 years and older for treatment of severe COVID-19 infections.{{cite web |title=FDA Approves First Treatment for COVID-19 |url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19 |publisher=US Food and Drug Administration |access-date=January 27, 2022 |date=October 22, 2020}} In January 2022, the FDA gave regulatory approval to Veklury for use in adults and children (12 years of age and older who weigh at least {{convert|40|kg}} and are positive for COVID-19, not hospitalized, and are ill having high risk for developing severe COVID-19, including hospitalization or death.{{cite web |title=FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19 |url=https://www.fda.gov/news-events/press-announcements/fda-takes-actions-expand-use-treatment-outpatients-mild-moderate-covid-19 |publisher=US Food and Drug Administration |access-date=January 26, 2022 |date=January 21, 2022}}

The FDA also provided Emergency Use Authorization for Veklury 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.

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