GILEAD SCIENCES, INC. (GILD) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that GILEAD SCIENCES, INC. surfaced in its latest filing.

• The FDA has required a class-wide Boxed Warning for all approved CAR T-cell therapies regarding the risk of T-cell malignancies.
• Discontinuation of Phase 3 EVOKE-03 study evaluating sacituzumab govitecan-hziy with pembrolizumab in certain patients with previously untreated metastatic non-small cell lung cancer in June 2026.June 2026
• Impairment charge recorded during the three months ended June 30, 2026 related to the EVOKE-03 discontinuation.June 30, 2026
• In December 2025, Gilead reached an agreement with the U.S. administration to exclude Gilead branded pharmaceutical products from Section 232 tariffs for three years, provided Gilead invests in U.S. manufacturing.December 2025
• Gilead agreed to implement MFN prices in Medicaid for select existing products through the GENEROUS Model and MFN prices in the U.S. market for future launched products.
• Gilead agreed to set a new direct-to-patient price for Epclusa.
• Gilead agreed to return a portion of increased international revenues to the U.S. if the U.S. government is successful in increasing drug prices abroad.
• In April 2026, the U.S. President issued a Proclamation imposing 100% tariffs on patented pharmaceutical products and associated pharmaceutical ingredients, expected to take effect in the second half of 2026.April 2026
• Gilead implemented a contract pharmacy integrity initiative for its branded HCV products in March 2022, requiring covered entities to provide claims level data for units dispensed from contract pharmacies.March 2022
• CMS established a severity-adjusted DRG 018 for Medicare inpatient reimbursement of CAR T-cell products such as Yescarta and Tecartus.
• FDA has authorized proposed programs in Florida and Colorado to import prescription drugs from Canada.
• The company has entered into agreements with generic drug manufacturers as well as licensing agreements with the Medicines Patent Pool, allowing generic manufacture of certain products for low- and middle-income countries.
• In the EU, the company is required to permit products purchased in one EU member state to be sold in another member state.
• As part of a U.S. civil enforcement lawsuit, the company seized thousands of bottles of Gilead-labeled medication with counterfeit supply chain documentation and its investigation revealed that unauthorized pharmaceutical distributors sold counterfeit Gilead medicine to independent pharmacies nationwide.
• The Department of Health and Human Services selected Biktarvy for Maximum Fair Price determination under Medicare, effective beginning in 2028.2028
• The EU has proposed General Pharmaceutical Legislation that could impose additional obligations on manufacturers to launch and supply products across member states and reduce regulatory data protection periods.
• In January 2026, the EMA and FDA jointly established new AI principles in drug development that may lead to future regulatory guidance affecting the use of AI in the company's business.January 2026
• The Department of Justice Final Rule on Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons impacts how and where clinical and other sensitive data is shared.
• The U.S. Supreme Court decision to overrule the Chevron doctrine may lead to changing and evolving interpretations of laws and regulations.
• The company is investing $32 billion in the U.S. through 2030 to expand manufacturing and R&D.2030
• The company is subject to income taxes in the U.S. and various foreign jurisdictions, including Germany and Ireland.