Biktarvy Sales Increased 7% Year-Over-Year to $3.8 billion

Diluted Loss Per Share was $(8.45) and Non-GAAP Diluted Loss Per Share was $(6.75) Reflecting $(9.08) Per Share Acquired IPR&D and Tax Expenses Associated with Recent Acquisitions

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the second quarter 2026.

“Gilead delivered a very strong second quarter, with 10% year-over-year revenue growth in our base business driven by our HIV portfolio, Trodelvy and Livdelzi. HIV sales grew 12%, reflecting continued strength in treatment and the rapid expansion of our PrEP business, supporting an increase in our base business revenue expectations for 2026,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “We also made significant clinical progress with three FDA approvals and three positive Phase 3 updates. We look forward to delivering on our many opportunities in the second half of the year including another two potential launches in oncology and HIV.”

Second Quarter 2026 Financial Results

• Total second quarter 2026 revenues increased 10% to $7.8 billion compared to the same period in 2025, primarily driven by:
  • Higher sales of HIV products, Trodelvy® (sacituzumab govitecan-hziy) and Livdelzi® (seladelpar), partially offset by lower sales of Veklury® (remdesivir) as well as Cell Therapy and chronic hepatitis C virus (“HCV”) products; and
  • Higher royalty, contract and other revenues related to a previous sale of intellectual property.
• Diluted (loss) earnings per share (“EPS”) was $(8.45) in the second quarter 2026 compared to $1.56 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired in-process research and development (“IPR&D”) expenses associated with our acquisitions of Arcellx, Inc. (“Arcellx”), Tubulis GmbH (“Tubulis”) and Ouro Medicines, LLC (“Ouro Medicines”), net of the impact of our collaboration with Lakefront Biotherapeutics NV (“Lakefront”) and the related taxes, as well as an IPR&D impairment related to assets previously acquired from Immunomedics, Inc. (“Immunomedics”) and higher operating expenses. The decrease was partially offset by higher revenues, lower income tax expense, and higher net gains from equity securities.
• Non-GAAP diluted (loss) EPS was $(6.75) in the second quarter 2026 compared to $2.01 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired IPR&D and tax expenses discussed above, as well as higher non-GAAP selling, general and administrative (“SG&A”) expenses and non-GAAP income tax expense, partially offset by higher revenues.
• As of June 30, 2026, Gilead had $3.2 billion of cash, cash equivalents and marketable debt securities compared to $10.6 billion as of December 31, 2025. The decrease was primarily driven by year-to-date cash outflows of $11.3 billion related to acquisitions, $2.8 billion of debt repayments, $2.1 billion of dividend payments and $774 million of common stock repurchases, partially offset by $4.1 billion of net proceeds from debt financing and $6.1 billion of operating cash flow.
• During the second quarter 2026, Gilead generated $3.6 billion in operating cash flow.
• During the second quarter 2026, Gilead paid dividends of $1.0 billion and repurchased $355 million of common stock.

Second Quarter 2026 Product Sales

Total second quarter 2026 product sales increased 8% to $7.6 billion compared to the same period in 2025. Total second quarter 2026 product sales excluding Veklury increased 10% to $7.6 billion compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of Cell Therapy and HCV products.

HIV product sales increased 12% to $5.7 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand.

• Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 7% to $3.8 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price, favorable inventory dynamics and higher demand.
• Descovy® (FTC 200mg/TAF 25mg) sales increased 48% to $967 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand.

The Liver Disease portfolio sales increased 10% to $877 million in the second quarter 2026 compared to the same period in 2025, primarily reflecting higher demand for Livdelzi, as well as chronic hepatitis B virus (“HBV”) products and Hepcludex® (bulevirtide-gmod), partially offset by lower sales for HCV products.

Veklury sales decreased 81% to $23 million in the second quarter 2026 compared to the same period in 2025, primarily driven by lower rates of COVID-19-related hospitalizations.

Cell Therapy product sales decreased 14% to $417 million in the second quarter 2026 compared to the same period in 2025, reflecting ongoing competitive headwinds.

• Yescarta® (axicabtagene ciloleucel) sales decreased 12% to $346 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in- and out-of-class competition.
• Tecartus® (brexucabtagene autoleucel) sales decreased 24% to $70 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in-class competition.

Trodelvy® (sacituzumab govitecan-hziy) sales increased 26% to $457 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher demand.

Second Quarter 2026 Product Gross Margin, Operating Expenses and Effective Tax Rate

• Product gross margin remained relatively flat at 79.3% in the second quarter 2026 compared to 78.7% in the same period in 2025. Non-GAAP product gross margin also remained flat at 86.9% in the second quarter 2026 compared to the same period in 2025.
• Research and development (“R&D”) expenses were $1.8 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily due to integration costs and other acquisition-related expenses, partially offset by lower oncology clinical study activity. Non-GAAP R&D expenses were $1.4 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily driven by lower oncology clinical study activity.
• Acquired IPR&D expenses were $11.2 billion in the second quarter 2026, primarily related to $7.0 billion for the Arcellx acquisition, $3.1 billion for the Tubulis acquisition and $1.0 billion for the Ouro Medicines acquisition, net of the impact of the Lakefront collaboration.
• SG&A expenses were $1.9 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily driven by integration costs related to the acquisitions and higher HIV promotional activities. Non-GAAP SG&A expenses were $1.5 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily due to higher HIV promotional activities.
• The effective tax rate (“ETR”) was (2.4)% in the second quarter 2026 compared to 19.3% in the same period in 2025. The non-GAAP ETR was (11.4)% in the second quarter 2026 compared to 18.8% in the same period in 2025. These changes primarily reflect the non-deductible acquired IPR&D expenses related to our acquisitions of Arcellx, Tubulis, and Ouro Medicines.

Guidance and Outlook

For the full year 2026, Gilead now expects:

Our full year 2026 GAAP and non-GAAP diluted loss per share guidance includes the impact of approximately $9.08 due to acquired IPR&D charges of $11.1 billion related to the Arcellx, Tubulis and Ouro Medicines transactions, net of the impact of the Lakefront collaboration and related taxes.

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.

Key Updates Since Our Last Quarterly Release

Virology

• Announced U.S. Food and Drug Administration (“FDA”) accepted a supplemental New Drug Application submission for Yeztugo® (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis (“PrEP”), with a Prescription Drug User Fee Act target action date of February 2, 2027.
• Announced positive Phase 3 results from the ISLEND-1 and ISLEND-2 trials, in partnership with Merck, evaluating an investigational long-acting oral treatment regimen of islatravir 2 mg and lenacapavir 300 mg in adults with HIV who are virologically suppressed and switched from Biktarvy (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2) to the once-weekly combination.
• 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.
• Announced a donation of 2,000 vials of remdesivir to the Republic of Uganda to support response efforts to the current outbreak of Ebola Bundibugyo virus disease (“BVD”). Remdesivir is not approved for the treatment of Ebola virus disease, including BVD, anywhere globally, and the safety and efficacy of this use is not known.

Oncology

• Received FDA approval of Trodelvy for the first-line (“1L”) treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (“mTNBC”) as either a single agent for patients who are not candidates for PD-1/PD-L1 inhibitor-based therapy or in combination with Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) for patients whose tumors express PD-L1 (CPS ≥10).
• Announced European Commission marketing authorization for Trodelvy as a monotherapy for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1/PD-L1 inhibitor therapy.
• 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 mTNBC who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 (CPS≥10).
• Announced the discontinuation of the Phase 3 EVOKE-03 study, in partnership with Merck, evaluating Trodelvy in combination with Keytruda® for the investigational treatment of 1L metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%). The decision was based on the recommendation of the external Data Monitoring Committee, following review of data from a pre-specified final analysis of progression-free survival and interim analysis of overall survival.
• Presented new analyses at the 2026 American Society of Clinical Oncology meeting from the Phase 3 ASCENT-03 and ASCENT-04 studies evaluating Trodelvy with or without Keytruda® in 1L mTNBC, as well as new data on investigational anitocabtagene-autoleucel (“anito-cel”) clinical trial manufacturing experience in patients with newly diagnosed or relapsed/refractory multiple myeloma.
• Presented updated Phase 1 results for KITE-753, an investigational bicistronic autologous CD19/CD20 CAR T-cell therapy for relapsed or refractory B-cell lymphoma at the 2026 European Hematology Association meeting.
• Completed the acquisition of Tubulis for $3.15 billion in upfront consideration. This acquisition brings Gilead next-generation antibody-drug conjugate (“ADC”) assets, including GS-8824, a NaPi2b-directed topoisomerase-I inhibitor ADC, and a platform to develop novel ADCs.

Inflammation

• Completed the acquisition of Ouro Medicines for $1.675 billion in upfront consideration, which brings Gilead gamgertamig, an investigational clinical stage BCMAxCD3 T cell engager for autoimmune diseases. The acquisition was completed in collaboration with Lakefront, which equally shared the upfront payment and will equally share contingent milestone payments, subject to customary adjustments.
• Announced positive results from the Phase 3 IDEAL study, supporting the potential of Livdelzi to help people living with primary biliary cholangitis (“PBC”) with elevated alkaline phosphatase (“ALP”) levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with ursodeoxycholic acid (“UDCA”), or who are intolerant to UDCA.
• Presented data from the open-label Phase 3 ASSURE study at the 2026 European Association for the Study of the Liver Congress evaluating the long-term safety and tolerability profile of Livdelzi in people living with PBC with elevated ALP levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with UDCA, or who are intolerant to UDCA.

Corporate

• Issued $3.0 billion aggregate principal amount of senior unsecured notes and borrowed $1.1 billion aggregate principal amount under a one-year term loan facility.
• Announced a renewed 5-year collaboration with the World Health Organization to commit funding, strategic support and AmBisome donations toward eliminating visceral leishmaniasis.
• The Board declared a quarterly dividend of $0.82 per share of common stock for the third quarter of 2026. The dividend is payable on September 29, 2026, to stockholders of record at the close of business on September 15, 2026. Future dividends will be subject to Board approval.

Certain amounts and percentages in this press release may not sum or recalculate due to rounding.