Gilead Sciences, Inc. (GILD) SEC Filings & Earnings Calls

IRA Medicare negotiation for Biktarvy

“In January 2026, the Department of Health and Human Services selected Biktarvy for Maximum Fair Price determination under Medicare, effective beginning in 2028, and more of our products may be selected in the future.” · word for word

MFN pricing commitments

“In December 2025, Gilead reached an agreement with the administration to ... implement MFN prices in Medicaid for select existing products through the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model and MFN prices in the U.S. market for future launched products.” · word for word

Section 232 tariffs on pharmaceuticals

“In April 2026, the U.S. President issued a Proclamation imposing 100% tariffs on patented pharmaceutical products and associated pharmaceutical ingredients, with such tariffs expected to take effect in the second half of 2026.” · word for word

Phase 3 EVOKE-03 failure

“In June 2026, we and Merck announced the discontinuation of the Phase 3 EVOKE-03 study evaluating sacituzumab govitecan-hziy in combination with pembrolizumab in certain patients with previously untreated metastatic non-small cell lung cancer, which resulted in us recording an impairment charge during the three months ended June 30, 2026.” · word for word

Cell therapy manufacturing and reimbursement risks

“We also face risks related to our in-house CAR T-cell therapy manufacturing facilities in California, Maryland and the Netherlands, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.” · word for word

Cell Therapy sales declining due to competition; Yescarta -12%, Tecartus -24%.

“Cell Therapy product sales decreased 14% to $417 million... Yescarta sales decreased 12%... Tecartus sales decreased 24%”

Veklury sales collapsed 81% as COVID-19 hospitalizations decline.

“Veklury sales decreased 81% to $23 million” · word for word

Cash burn from acquisitions: $11.3B YTD outflows, cash reduced from $10.6B to $3.2B.

“year-to-date cash outflows of $11.3 billion related to acquisitions... cash, cash equivalents and marketable debt securities compared to $10.6 billion as of December 31, 2025”

Increased leverage from $3B debt issuance may pressure interest coverage ratios.

“Creation of direct financial obligation under Item 2.03.”

Cell Therapy sales declining due to competitive headwinds; Veklury sales declining as COVID-19 hospitalizations decrease.

“Cell Therapy product sales decreased 12%; Veklury sales decreased 52%”

Drug pricing and reimbursement pressure

“In January 2026, the Department of Health and Human Services selected Biktarvy for Maximum Fair Price determination under Medicaid, effective beginning in 2028, and more of our products may be selected in the future.” · word for word

Tariff risk on pharmaceutical imports

“in April 2026, the U.S. President issued a Proclamation imposing 100% tariffs on patented pharmaceutical products and associated pharmaceutical ingredients, with such tariffs expected to take effect in the second half of 2026.” · word for word

IRA and OBBB impact on profitability

“we anticipate that the IRA will increase our payment obligations under the redesigned Part D 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.” · word for word

Clinical trial failure

“in January 2024, we announced that our Phase 3 EVOKE-01 study evaluating sacituzumab govitecan-hziy ("SG") did not meet its primary endpoint of overall survival in previously treated metastatic non-small cell lung cancer ("NSCLC"), which resulted in us recording an impairment charge during the three months ended March 31, 2024” · word for word

Integration risk and high acquisition cost may strain financials if anito-cel sales milestones not met.

“CVR payment contingent on cumulative worldwide sales exceeding $6.0 billion by Dec 31, 2029.”

Patent litigation and regulatory risk related to HIV drugs

“Lawsuits continue over older Gilead HIV drugs containing tenofovir disoproxil fumarate, such as Truvada. Gilead is charged with intentionally withholding a safer alternative to maximize profits and failed to warn patients of the risk of kidney and bone damage. There are thousands of pending state-level cases.” · word for word

Clinical hold on HIV treatments

“The U.S. Food and Drug Administration placed a clinical hold on trials for two investigational HIV treatments, GS-1720 and GS-4182. There was a decrease in a type of white blood cell in some trial participants.” · word for word

Oncology pipeline setbacks

“Gilead's efforts to expand its oncology portfolio faced setbacks with the failure of two late-stage clinical trials for its cancer drug Trodelvy. A trial for metastatic urothelial cancer failed, along with another study for previously treated metastatic non-small cell lung cancer.” · word for word

Cell Therapy and liver disease sales decline

“The Cell Therapy franchise (Yescarta and Tecartus) and the liver disease portfolio both experienced sales decreases due to competitive pressures.” · word for word

Insider stock sales

“Per an October 2025 MarketBeat report recent insider Gilead stock sales could be a point of concern for investors, potentially signaling a lack of confidence in Gilead's short-term performance.” · word for word

IRA Medicare negotiation on Biktarvy

“In January 2026, the Department of Health and Human Services selected Biktarvy for Medicare negotiation of Medicare prices that will be effective beginning in 2028.” · word for word

Potential tariffs on pharmaceuticals

“In September 2025, the U.S. Presidential administration announced plans to impose up to 100% tariffs on imported branded or patented pharmaceuticals.” · word for word

Cell therapy competitive headwinds

“Total Cell Therapy 1,839 (2025) vs 1,973 (2024) = -7%.”

Regulatory approval risk for anito-cel; integration risk; CVR contingent on sales milestone.

“Transaction subject to regulatory approvals; anito-cel BLA pending FDA decision by December 23, 2026.”

Cell Therapy segment faces competitive headwinds; Veklury sales declining due to lower COVID-19 hospitalizations.

“Cell Therapy product sales decreased 6%; Veklury sales decreased 37%.”

Trodelvy Impairment Risk

“While we currently do not anticipate this information will result in an impairment of the associated finite-lived intangible asset related to Trodelvy, potential future adverse changes in estimated Trodelvy revenues could negatively impact our results of operations and result in impairment charges in future periods.” · word for word

Cell Therapy Competitive Pressure

“Cell Therapy product sales decreased 11% to $432 million for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to lower demand reflecting ongoing competitive headwinds.” · word for word

Veklury Revenue Decline

“Veklury product sales decreased 60% to $277 million for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to lower rates of COVID-19-related hospitalizations.” · word for word

Medicare Part D Pricing Headwind

“HIV product sales increased 4% ... partially offset by lower average realized price driven by the U.S. Medicare Part D program redesign impact.”

Litigation Exposure

“We are a party to various legal actions. ... If plaintiffs are successful in their claims, we could be required to pay significant monetary damages, which may result in a material, adverse effect on our results of operations and financial condition.” · word for word

Cell Therapy sales declining due to competitive headwinds.

“Cell Therapy product sales decreased 11% to $432 million in the third quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds.” · word for word

Veklury sales declining as COVID-19 hospitalizations decrease.

“Veklury sales decreased 60% to $277 million in the third quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations.” · word for word