GILD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-10-30

• •In October 2026, the Centers for Medicare and Medicaid Services completed the process of setting the Maximum Fair Price for Biktarvy under Medicare. The new price will be effective and impact our Biktarvy revenue starting January 1, 2028.

• •Received U.S. Food and Drug Administration (“FDA”) approval for Bixlenvo for the treatment of HIV in adults who are virologically suppressed on a stable antiretroviral regimen, including those switching from complex multi-tablet regimens. Bixlenvo is a complete single-tablet regimen indicated for t…

• •Announced FDA accepted a supplemental New Drug Application (“NDA”) submission for Yeztugo 300-mg tablet as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis, with a Prescription Drug User Fee Act (“PDUFA”) target action date of February 2, 2027.

• •Received FDA accelerated approval for Hepcludex for the treatment of chronic hepatitis delta virus (“HDV”) infection in adults without cirrhosis or with compensated cirrhosis, which is now the first and only FDA-approved treatment for HDV in the U.S.

• •Received European Commission (“EC”) marketing authorization for Trodelvy in combination with Keytruda® (pembrolizumab) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (“mTNBC”) who have not received prior systemic therapy for metast…

Text removed vs the prior filing · source: 10-Q · 2026-08-06

• •Announced U.S. Food and Drug Administration (“FDA”) accepted a supplemental New Drug Application (“NDA”) submission for Yeztugo 300-mg tablet as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis, with a Prescription Drug User Fee Act (“PDUFA”) target action date of February …

• •Received FDA accelerated approval for Hepcludex for the treatment chronic hepatitis delta virus (“HDV”) infection in adults without cirrhosis or with compensated cirrhosis, which is now the first and only FDA-approved treatment for HDV in the U.S.

• •Announced FDA accepted an NDA for bictegravir and lenacapavir for virologically suppressed people with HIV under priority review, with a PDUFA target action date of August 27, 2026.

• •Received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Trodelvy in combination with Keytruda® (pembrolizumab) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (“mTNBC”) who…

• •Completed the acquisition of Ouro Medicines, LLC (“Ouro Medicines”), which adds gamgertamig, a clinical stage BCMAxCD3 T cell engager for autoimmune diseases, to Gilead’s inflammation portfolio. The acquisition was completed in collaboration with Lakefront Biotherapeutics NV (“Lakefront”) (formerly…

Text added vs the prior filing · source: 10-Q · 2026-10-30

• discount program, limit the prices we can charge for our products, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results.

• •In July 2025, U.S. Congress enacted the One Big Beautiful Bill Act (the “OBBBA”), which made several changes to the Medicaid program, such as imposing Medicaid work requirements and stricter eligibility and enrollment standards. Most of these policies will take effect in 2027. The OBBBA also elimin…

• •The current U.S. Presidential administration has indicated that it plans to pursue additional policies aimed at lowering prescription drug costs. The administration has issued multiple executive orders and statements reflecting its intent to require pharmaceutical manufacturers to offer U.S. prices…

• •In April 2025, the U.S. Department of Commerce initiated an investigation pursuant to Section 232 to assess whether imports of pharmaceuticals and pharmaceutical ingredients into the United States pose a national security risk. Following this investigation, in April 2026, the U.S. President issued …

• We are also aware of the existence of various suppliers around the world that, without Gilead’s authorization, purport to source our products and generic versions of our products and sell them for use in countries where those products have not been approved. As a result, patients may be at risk of t…

Text removed vs the prior filing · source: 10-Q · 2026-08-06

• •In July 2025, U.S. Congress enacted the One Big Beautiful Bill Act, which made several changes to the Medicaid program, such as imposing Medicaid work requirements and stricter eligibility and enrollment standards. Most of these policies will take effect in 2027. In addition, as of the end of 2025,…

• •The current U.S. Presidential administration has indicated that it plans to pursue additional policies aimed at lowering prescription drug costs. The administration has issued multiple executive orders and statements that illustrate the intent to require pharmaceutical manufacturers to offer U.S. p…

• •In April 2025, the U.S. Department of Commerce initiated an investigation pursuant to Section 232 to assess whether imports of pharmaceuticals and pharmaceutical ingredients into the United States pose a national security risk. Following this investigation, in April 2026, the U.S. President issued …

• unintended consequence of an increasingly out of scope percentage of sales at deeply discounted 340B prices due, in part, to pervasive violations of the program’s diversion and duplicate discount prohibitions. Detecting and remedying these program integrity violations is challenging.

• We are also aware of the existence of various suppliers around the world that, without Gilead’s authorization, purport to source our products and generic versions of our products and sell them for use in countries where those products have not been

Text added vs the prior filing · source: 10-Q · 2026-10-30

• On August 7, 2026, Keeley Cain Wettan, our Executive Vice President and General Counsel, Legal and Compliance, adopted a trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell, subject to certain conditions, through September 30, 2027, the net shares of our common stock to be…

• On August 13, 2026, Kelly Kramer, a member of our Board of Directors, adopted a trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell up to 19,872 shares of our common stock through August 10, 2027, subject to certain conditions.

Text removed vs the prior filing · source: 10-Q · 2026-08-06

• On May 27, 2026, Anthony Welters, a member of our Board of Directors, adopted a trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell up to 18,000 shares of our common stock through December 31, 2026, subject to certain conditions.