Gilead Earnings Call Highlights Need for Congress to Act Quickly to Protect Patients

Gilead Q1 2020: $874M in cash dividends, $1.3B in stock buybacks, stock up 20%

Gilead CEO cites responsibilities to shareholders, claims it’s “too premature” to speculate on COVID-19 profits

REMINDER: Remdesivir discovered with taxpayer dollars in collaboration with CDC, Department of Defense

FLASHBACK: “HIV treatment cost taxpayers millions…[Gilead] making billions”

FLASHBACK: Gilead tries to exploit FDA loophole to get exclusive rights to taxpayer-funded COVID-19 treatment, backs down after public backlash

Washington, DC – Today, Patients Over Pharma released the following statement and supporting research in response to Gilead Sciences’ first quarter earnings call on April 30th. As Congress negotiates additional legislation to respond to the COVID-19 crisis, Patients Over Pharma is calling on them to include provisions to protect patients and ensure that COVID-19 vaccines and treatments are affordable for every American, a position that recent polling shows has overwhelming support.

“Gilead has already demonstrated that they are willing to charge patients exorbitant prices for lifesaving HIV drugs developed using taxpayer dollars, to the point where even the Trump Administration sued them for price-gouging,”said Eli Zupnick, spokesman for Patients Over Pharma. “So while we all hope that remdesivir pans out as an effective COVID-19 treatment, there is absolutely no reason to trust that Gilead would make it affordable and accessible for patients if doing so hurt their bottom line. Gilead reiterated that they have a responsibility to their shareholders to maximize profits, now Congress needs to live up to their responsibility to protect patients and ensure that any COVID-19 vaccine or treatment developed using taxpayer dollars is affordable and accessible to every American.”

Background on Gilead’s history of price gouging 

Headline: Washington Post: “An HIV treatment cost taxpayers millions. The government patented it. But a pharma giant is making billions.” [Washington Post, 3/26/19]

U.S. Government Funded Research That Led To Gilead HIV Drug Truvada – Gilead Has Fought Government Attempts To Collect Royalties Or Distribute The Drug More Widely. “Thomas Folks spent years in his U.S. Centers for Disease Control and Prevention lab developing a treatment to block deadly HIV in monkeys. Then San Francisco AIDS researcher Robert Grant, using $50 million in federal grants, proved the treatment worked in people who engaged in risky sex. Their work — almost fully funded by U.S. taxpayers — created a new use for an older prescription drug called Truvada: preventing HIV infection. But the U.S. government, which patented the treatment in 2015, is not receiving a penny for that use of the drug from Gilead Sciences, ­Truvada’s maker, which earned $3 billion in Truvada sales last year. Gilead argues that the government’s patents for Truvada for PrEP, as the prevention treatment is called, are invalid. And the government has failed to reach a deal for royalties or other concessions from the company — benefits that could be used to distribute the drug more widely.” [Washington Post, 3/26/19]

November 2019: Trump Administration Sued Gilead For Abusing Patents On HIV Drug It Developed With Taxpayer-Funded Research.“The Trump administration on Wednesday sued Gilead Sciences, a pharmaceutical company that sells H.I.V.-prevention drugs that can cost patients up to $20,000 a year, accusing the company of earning billions from research funded by taxpayers without paying taxpayers back. The government said the company infringed upon patents owned by the Department of Health and Human Services, and had refused attempts by the department to license its patents and collect royalties. The company sells two drugs, Truvada and Descovy, that can be taken once daily to prevent H.I.V. infection, a strategy called pre-exposure prophylaxis, or PrEP.” [New York Times, 11/7/19]

Gilead Priced Its HIV Drug At As Much As $20,000/Year In The U.S. “The Trump administration on Wednesday sued Gilead Sciences, a pharmaceutical company that sells H.I.V.-prevention drugs that can cost patients up to $20,000 a year, accusing the company of earning billions from research funded by taxpayers without paying taxpayers back.” [New York Times, 11/7/19]

Generic Versions Of Gilead’s HIV Drug, Truvada, Cost Roughly $60/Year In Africa – Gilead Has Sued To Prevent Efforts To Introduce A Generic In U.S. “In Africa, generic Truvada costs about $60 per patient per year. Gilead has sued companies that have tried to bring generic versions to the United States, keeping them out of the market after secret settlements.” [New York Times, 11/7/19]

Gilead CEO Defended Company’s Pricing Practices As Necessary For Research Investment, Noting It Spent $6B On HIV/AID Research Since 2000. “The chief executive of Gilead Sciences, the nation’s leading manufacturer of HIV drugs, defended the high cost of a key drug that prevents the lethal infection, telling a House committee Thursday that its hefty profits pay for continued research. “We have taken the disease from a death sentence to a manageable clinical condition, but we’re not done yet,” Gilead CEO Daniel O’Day told committee members. “We have to be sure that Americans get our medicines at a price that allows us to invest in research.’’ He said Gilead has spent $6 billion on HIV/AIDS research since 2000.” [Washington Post, 5/16/19]

Gilead’s HIV Drug, Truvada, Has Earned Them Six Times That – $36 Billion – Since 2004. “Truvada has earned Gilead about $3 billion a year and $36 billion since the drug was approved in 2004, but it is about to lose its exclusive patent protection.” [Washington Post, 5/16/19]

2015: Gilead Priced Hepatitis C Medication At $1,000 Per Pill – So Cost Prohibitive That Department Of Veterans Affairs Told Some Patients It Couldn’t Afford To Offer The Treatment. “On Tuesday, a Senate report found Gilead Sciences, which makes a cure for a fatal form of hepatitis, is more interested in profits than patients. The cure was invented under the leadership of a celebrated doctor in the Department of Veterans Affairs, but at $1,000 a pill, even the VA can’t afford to save the lives of veterans who need it. . . . The drug — sofosbuvir — is sold as Sovaldi and Harvoni — and claims to cure up to 99 percent of hepatitis C patients. But there’s a catch, the retail price for a 12 week treatment is $84,000. The Department of Veterans Affairs gets a 50 percent discount, but even with that the VA told Yisrael they can’t afford to give it to everyone who needs it — including him.” [CBS News, 12/1/15]

Headline: FiercePharma: “Gilead prices hepatitis C giant Sovaldi in China at one-fifth the U.S. price: report.” [FiercePharma, 11/28/17]

Background from Gilead’s 4/30 earnings call

Gilead CEO: “We understand our responsibility both to patients and also to shareholders and we’ll be balancing that.” 

Gilead Claimed It Would Ensure That Remdesivir Would Be “Accessible And Affordable To Governments And Patients Around The World.” “We are authorized by regulator authorities Gilead will focus on making remdesivir both accessible and affordable to governments and patients around the world. Given the continued uncertainty in the trajectory of the pandemic and in remdesivir clinical data, it’s premature to define what the right post donation business model is to create a sustainable long-term supply for global needs. In the context of a strong underlying business in Q1 results, we will continue to monitor the situation and expect to provide additional insights and outlook on our Q2 earnings call.” [Gilead Q1 2020 earnings call transcript, 4/30/20]

Gilead Paid Out $874M In Cash Dividends To Shareholders And Made $1.3B In Stock Buybacks In First Quarter Of 2020. “As of March 31, 2020, Gilead had $24.3 billion of cash, cash equivalents and marketable debt securities, compared to $25.8 billion as of December 31, 2019. During the first quarter 2020, Gilead generated $1.4 billion in operating cash flow, repaid $500 million of debt, paid cash dividends of $874 million and utilized $1.3 billion on stock repurchases.” [Gilead press release, 4/30/20]

Gilead Dodged Question On Thinking Through Potential Revenues Of Remdesivir – Said They Would Provide Additional Guidance On Revenue Estimates On Q2 Call.
Michael Yee — Jefferies — Analyst: Yeah. Hi, Dan. So my question is for you guys on remdesivir as it relates to [Technical Issues] can you just describe the inputs and how to think about what revenue to the positive remdesivir could have this year? What have been the impacts on that inputs into that? On expenses, you guys obviously don’t expense guidance, you kind of walked through that. You described the approach dollars for remdesivir. Maybe just walk through the inputs there and how to think about why would it be on the lower end and comment on that because it makes the model. Yeah, so talk to that [Technical Issues] Thanks.

Daniel O’Day — Chairman and Chief Executive Officer: …So Michael, thank you for the call. On the revenue side, it is just as Andy mentioned also, and I mentioned it’s too premature. There is a lot of moving parts right now. Our focus will be on making sure we come up with a sustainable model that allows us to provide remdesivir to patients around the globe that — is intent on providing access and affordability. We’re just now going through the clinical data, the demand scenarios, the regulatory approvals, all these things are essential for us to inputs into our plan about how that will work post the donation. So we can’t really give more insight into that at this stage, but certainly when we can, we will….

Andrew Dickinson — Chief Financial Officer: … we’ll do everything we can to provide more color and commentary in particular on our Q2 earnings call. [Gilead Q1 2020 earnings call transcript, 4/30/20]

In Response To Questions On Licensing Out IP And Manufacturing Ensuring Global Access To Remdesivir, Gilead Said It Would Follow Similar Model As It Did To Its HIV Drugs:
Geoff Meacham — Bank of America — Analyst: …And then on remdesivir access, is there a model to license out IP and our manufacturing. I’m just thinking about how to accelerate perhaps broader access outside the US. Thank you.

Andrew Dickinson — Chief Financial Officer: …Look, on the manufacturing side, I’d say a couple of things at a high level. Is it again, our primary focus is on providing access to patients around the world. So just like we did with our HIV medicines and HCV medicines, we are deeply focused on this. We are — we have two separate work streams, one is working on our internal supply chain and making sure that we have a robust supply of starting materials intermediates and a strong manufacturing consortium with companies around the world. You’ve seen some of the references to that and Dan’s CEO letters and I would expect that will provide some additional information over the coming weeks and months. [Gilead Q1 2020 earnings call transcript, 4/30/20]

Remdesivir developed with taxpayer support 

Remdesivir, Originally Labeled GS-5734, Was Discovered Through A Collaboration Between Gilead, CDC And The U.S. Army Medical Research Institute Of Infectious Diseases (USAMRIID) On Ebola Treatments.“GS-5734 is a monophosphoramidate prodrug of an adenosine analog that was discovered through a collaboration among Gilead, the Centers for Disease Control & Prevention, and the U.S. Army Medical Research Institute of Infectious Diseases. Discovered in 2014, the compound already has been shown to wipe out signs of the virus in monkeys.” [American Chemical Society – Chemical & Engineering News, 7/6/16]

October 2015: Gilead Press Release Confirmed GS-5734 Was Identified In Collaboration With CDC And USAMRIID. “GS-5734 was discovered as part of Gilead’s program to screen compounds in its libraries for activity against a range of potential emerging viruses, including Ebola. In collaboration with the Centers for Disease Control and Prevention (CDC) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the company identified GS-5734 in vitro activity against the Ebola virus. In animal studies conducted at USAMRIID, treatment initiated on day 3 post-infection with Ebola virus resulted in 100 percent survival of monkeys.” [Gilead press release, 10/21/15]

March 2016 Study Of Effect Of GS-5734 In Monkeys Was Led By Researchers At USAMRIID. “Travis Warren, Ph.D., a principal investigator at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and first author of the paper, said the work published today is the result of continuing collaborations between USAMRIID and Gilead Sciences of Foster City, Calif. Scientists at the Centers for Disease Control and Prevention (CDC) also contributed by performing initial screening of the Gilead Sciences compound library to find molecules with promising antiviral activity. That initial work identified the precursor to GS-5734, a small-molecule antiviral agent, which led to the effort by Gilead and USAMRIID to further refine, develop and profile the compound. Led by USAMRIID Science Director Sina Bavari, Ph.D., the paper’s senior author, the research team used cell culture and animal models to demonstrate the compound’s antiviral activity against several pathogens, including Ebola virus.” [USAMRIID press release, 3/3/16]

Initial GS-5734 Studies Were Conducted With Funding From The Department Of Defense And CDC. “These studies were in part supported by The Joint Science and Technology Office for Chemical and Biological Defense (JSTO-CBD) of the Defense Threat Reduction Agency (DTRA) under Plan No. CB10218. CDC core funding supported the work done by M.K.L. at CDC.” [Journal of Medicinal Chemistry, 1/26/17]

2016: Department Of Defense Awarded $1.2M To Gilead To Fund A Study On Ebola Treatment. In 2016, the Department of Defense awarded Gilead $1,196,950 for a “blinded randomized controlled study for Ebola.” [USASpending.gov, start date 5/12/16]