Pembrolizumab

Product Sales Excluding Veklury Increased 16% Year-Over-Year to $8.2 Billion Biktarvy Sales Increased 10% Year-Over-Year to $4.1 Billion FOSTER CITY, Calif.--(BUSINESS WIRE)-- #Earnings --Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter 2026. “Gilead delivered an exceptional third quarter, with our strongest year-over-year base business growth in more than a decade, reflecting the strength, breadth and durability of our business,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “Our performance enabled us to raise our full year base business revenue guidance again this quarter, bringing the total increase to $1.6 billion since the start of 2026. Our HIV business grew 18% and HIV prevention sales nearly doubled year-over-year. With multiple ongoing and potential launches across HIV and Oncology, important progress in Inflammation and a disciplined operating model, Gilead is well positioned for business growth and impact for patients.” Third Quarter 2026 Financial Results Total third quarter 2026 product sales increased 13% to $8.3 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) and Cell Therapy products. Higher product sales were partially offset by lower royalty, contract and other revenues, primarily driven by revenues recognized in the prior year related to a previous sale of intellectual property, which did not repeat in the current year. Diluted earnings per share (“EPS”) was $1.94 in the third quarter 2026 compared to $2.43 in the same period in 2025. The decrease was primarily driven by net losses from equity securities in the current year compared to net gains in the prior year, higher operating expenses, higher income tax expense and lower royalty, contract and other revenues, partially offset by higher product sales and lower acquired in-process research and development (“IPR&D”) expenses. Non-GAAP diluted EPS was $2.55 in the third quarter 2026 compared to $2.47 in the same period in 2025. The increase was primarily driven by higher product sales and lower acquired IPR&D expenses, partially offset by higher operating expenses, higher income tax expense and lower royalty, contract and other revenues. As of September 30, 2026, Gilead had $6.4 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, $3.1 billion of dividend payments and $1.1 billion of common stock repurchases, partially offset by $11.2 billion of operating cash flow and $4.1 billion of net proceeds from debt financing. During the third quarter 2026, Gilead generated $5.0 billion in operating cash flow. During the third quarter 2026, Gilead paid dividends of $1.0 billion and repurchased $370 million of common stock. Third Quarter 2026 Product Sales As noted in the section above, total third quarter 2026 product sales increased compared to the same period in 2025. Total third quarter 2026 product sales excluding Veklury increased 16% to $8.2 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 products. HIV product sales increased 18% to $6.2 billion in the third quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price, higher demand in HIV prevention and favorable inventory dynamics. Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 10% to $4.1 billion in the third quarter 2026 compared to the same period in 2025, primarily driven by higher demand, higher average realized price and favorable inventory dynamics. Descovy® (FTC 200mg/TAF 25mg) sales increased 49% to $1.0 billion in the third quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and favorable inventory dynamics. The Liver Disease portfolio sales increased 13% to $927 million in the third quarter 2026 compared to the same period in 2025, primarily reflecting higher demand for Livdelzi, as well as higher average realized price for chronic hepatitis C virus (“HCV”) and chronic hepatitis B virus products, partially offset by lower demand for HCV products. Veklury sales decreased 69% to $86 million in the third quarter 2026 compared to the same period in 2025, primarily driven by lower rates of COVID-19-related hospitalizations. Cell Therapy product sales decreased 18% to $355 million in the third quarter 2026 compared to the same period in 2025, reflecting ongoing competitive headwinds. Trodelvy® (sacituzumab govitecan-hziy) sales increased 42% to $506 million in the third quarter 2026 compared to the same period in 2025, primarily driven by higher demand. Third Quarter 2026 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 81.0% in the third quarter 2026 compared to 78.6% in the same period in 2025. Non-GAAP product gross margin was 88.1% in the third quarter 2026 compared to 86.5% in the same period in 2025. These increases were primarily driven by the expiration of a royalty-related obligation. Research and development (“R&D”) expenses and non-GAAP R&D expenses increased to $1.6 billion in the third quarter 2026 compared to $1.3 billion in the same period in 2025, primarily driven by higher employee-related and clinical materials costs. Acquired IPR&D expenses were $18 million in the third quarter 2026. Selling, general and administrative (“SG&A”) expenses increased to $1.6 billion in the third quarter 2026 compared to $1.4 billion in the same period in 2025, primarily driven by higher HIV promotional activities, integration costs related to our recent acquisitions, higher expenses related to legal matters and higher employee-related costs. Non-GAAP SG&A expenses increased to $1.5 billion in the third quarter 2026 compared to $1.4 billion in the same period in 2025, primarily due to higher HIV promotional activities, higher expenses related to legal matters and higher employee-related costs. The effective tax rate (“ETR”) was 20.7% in the third quarter 2026 compared to 16.2% in the same period in 2025, primarily driven by a settlement with a tax authority and remeasurement of certain deferred tax liabilities in the prior year, which did not repeat in the current year. The non-GAAP ETR was 19.0% in the third quarter 2026 compared to 17.5% in the same period in 2025, primarily due to the settlement with a tax authority in the prior year. Guidance and Outlook For the full year 2026, Gilead now expects: (in millions, except per share amounts) October 29, 2026 Guidance Low End High End Comparison to August 4, 2026 Guidance Product sales $ 31,000 $ 31,300 Previously $30,100 to $30,400 Product sales excluding Veklury $ 30,700 $ 31,000 Previously $29,800 to $30,100 Veklury ~ $300 Unchanged Diluted loss per share $ (4.40 ) $ (4.05 ) Previously $(3.75) to $(3.40) Non-GAAP diluted loss per share $ (1.20 ) $ (0.85 ) Previously $(0.65) to $(0.30) Our full year 2026 GAAP and non-GAAP diluted loss per share guidance includes the impact of approximately $9.88 due to acquired IPR&D charges of $12.4 billion related to the Arcellx, Tubulis, Ouro Medicines and PepStar transactions announced this year, 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 Received U.S. Food and Drug Administration (“FDA”) approval for Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg) 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 the treatment of HIV to replace current antiretroviral regimens in people with virological suppression with no known or suspected resistance to bictegravir or lenacapavir. Announced the expansion of the six royalty-free voluntary licensing agreements for twice-yearly lenacapavir to include the investigational once-yearly lenacapavir for HIV prevention, if approved. This agreement covers 120 high-incidence countries and will support manufacturing readiness, technology transfer and future supply while the Phase 3 PURPOSE-365 trial is ongoing. If approved, once-yearly lenacapavir could provide a full year of HIV prevention with a single annual dose, expanding prevention choice and helping address barriers that can limit HIV pre-exposure prophylaxis (“PrEP”) uptake and persistence. Announced a new agreement with the Pan American Health Organization (“PAHO”) to accelerate access for twice-yearly lenacapavir for HIV prevention across all PAHO Member States in Latin America and the Caribbean. This agreement is part of Gilead’s broader global access strategy for lenacapavir which combines voluntary licensing, technology transfer, no-profit supply, regional access pathways and partnerships in providing access to HIV prevention. Oncology Announced 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 metastatic disease and whose tumors express PD-L1 (CPS≥10). This decision follows the recent EC approval of Trodelvy as a monotherapy for the treatment of adults with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-(L)1 inhibitors. Trodelvy is now the only approved Trop-2 directed ADC and backbone therapy for 1L mTNBC across PD-L1 status. Inflammation Announced a definitive agreement with PepStar Therapeutics Limited (“PepStar”), a privately held, clinical-stage biotechnology company, to acquire PepStar’s oral IL-23R inhibitor program. This includes lead asset HCXT-2001, an investigational, oral, macrocyclic peptide inhibitor of IL-23R, currently in Phase 1 development for immune-mediated inflammatory diseases. Closing of the transaction is subject to certain customary conditions. Presented new positive results from the Phase 2 SWIFT study evaluating emvistegrast, a once-daily oral alpha-4-beta-7 inhibitor, in adults with moderately-to-severely active ulcerative colitis (“UC”) at the United European Gastroenterology Week. Emvistegrast 200mg met its primary endpoint of clinical response at Week 12, with a generally well-tolerated safety profile. These findings support Gilead’s plans to initiate a Phase 3 study of emvistegrast 200mg as a monotherapy for UC in 2027. Emvistegrast is an investigational product that is not approved anywhere globally, and the safety and efficacy of its use is not yet established. Corporate Announced opening of new Research Center to expand capabilities in oncology, inflammation and research data science. The Research Center is the first of three projects supporting the $32 billion investment in U.S. research, development and manufacturing through 2030. 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. The Board declared a quarterly dividend of $0.82 per share of common stock for the fourth quarter of 2026. The dividend is payable on December 30, 2026, to stockholders of record at the close of business on December 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. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on and will be archived on for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets, restructuring charges and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities, the related tax charges or benefits associated with such exclusions and other discrete tax charges or benefits not representative of underlying trends such as changes in tax laws, transfers of intangible assets between certain legal entities, and effects of legal entity restructurings. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its full year 2026 financial guidance and future projected financial results; impacts resulting from regulatory or legislative policies or processes, including the impact from pricing reform in the Inflation Reduction Act (such as Medicare Part D pricing reform and the Biktarvy Maximum Fair Price determination), the expiration of subsidies related to the Affordable Care Act, our most-favored-nation pricing agreement with the U.S. government and tariffs; Gilead’s ability to make progress on any of its long-term ambitions or priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology, inflammation and other programs; Gilead’s ability to manage, execute and realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the announced PepStar acquisition; the risk that Gilead’s U.S. manufacturing and R&D investment may not achieve their intended benefits; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving anito-cel, emvistegrast, lenacapavir and HCXT-2001 (such as PURPOSE-365 and SWIFT), and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to resolve the issues cited by the FDA in pending clinical holds to the satisfaction of the FDA and the risk that FDA may not remove such clinical holds, in whole or in part, in a timely manner or at all; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, and the risk that any such approvals, if granted, may be subject to significant limitations on use and may be subject to withdrawal or other adverse actions by the applicable regulatory authority; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies, including Bixlenvo and Trodelvy; Gilead’s ability to effectively manage, execute and realize the anticipated benefits of the access strategy relating to lenacapavir for HIV PrEP, including voluntary licensing arrangements and external partnerships relating to lenacapavir; and other risks identified from time to time in Gilead’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended September 30, 2026 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Additional information is available on our Investor Relations website, . Among other things, an estimate of Acquired IPR&D expenses is expected to be made available on the Quarterly Results page within the first ten (10) days after the end of each quarter. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITE®, AMBISOME®, ATRIPLA®, BIXLENVO™, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, JYSELECA®, LIVDELZI®/LYVDELZI®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA®, TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA®, YEZTUGO®/YEYTUO® and ZYDELIG®. Other trademarks and trade names are the property of their respective owners. For more information on Gilead Sciences, Inc., please visit or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except per share amounts) 2026 2025 2026 2025 Revenues: Product sales $ 8,289 $ 7,345 $ 22,862 $ 21,013 Royalty, contract and other revenues 11 424 201 505 Total revenues 8,300 7,769 23,063 21,518 Costs and expenses: Cost of goods sold 1,571 1,569 4,595 4,610 Research and development expenses 1,608 1,346 4,744 4,215 Acquired in-process research and development expenses 18 170 11,307 485 In-process research and development impairments — — 1,750 190 Selling, general and administrative expenses 1,641 1,357 5,013 3,980 Total costs and expenses 4,838 4,442 27,409 13,480 Operating income (loss) 3,462 3,327 (4,346 ) 8,038 Interest expense 269 256 756 769 Other (income) expense, net 130 (569 ) (492 ) (449 ) Income (loss) before income taxes 3,063 3,641 (4,610 ) 7,718 Income tax expense 634 589 1,435 1,391 Net income (loss) $ 2,429 $ 3,052 $ (6,045 ) $ 6,327 Basic earnings (loss) per share $ 1.96 $ 2.46 $ (4.87 ) $ 5.08 Diluted earnings (loss) per share $ 1.94 $ 2.43 $ (4.87 ) $ 5.04 Shares used in basic earnings (loss) per share calculation 1,242 1,243 1,242 1,245 Shares used in diluted earnings (loss) per share calculation 1,251 1,254 1,242 1,256 Supplemental Information: Cash dividends declared per share $ 0.82 $ 0.79 $ 2.46 $ 2.37 Product gross margin 81.0 % 78.6 % 79.9 % 78.1 % Research and development expenses as a % of revenues 19.4 % 17.3 % 20.6 % 19.6 % Selling, general and administrative expenses as a % of revenues 19.8 % 17.5 % 21.7 % 18.5 % Operating margin 41.7 % 42.8 % (18.8 )% 37.4 % Effective tax rate 20.7 % 16.2 % (31.1 )% 18.0 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages) 2026 2025 Change 2026 2025 Change Product sales: HIV $ 6,249 $ 5,277 18 % $ 16,972 $ 14,952 14 % Liver Disease 927 819 13 % 2,571 2,372 8 % Oncology 860 788 9 % 2,543 2,395 6 % Other 167 184 (9 )% 524 594 (12 )% Total product sales excluding Veklury 8,203 7,068 16 % 22,610 20,313 11 % Veklury 86 277 (69 )% 253 700 (64 )% Total product sales 8,289 7,345 13 % 22,862 21,013 9 % Royalty, contract and other revenues 11 424 (97 )% 201 505 (60 )% Total revenues $ 8,300 $ 7,769 7 % $ 23,063 $ 21,518 7 % Contacts Investors: Jacquie Ross, CFA investor_relations@gilead.com Media: Ashleigh Koss public_affairs@gilead.com Read full story here

Preliminary responses observed in 6 of 8 evaluable urothelial carcinoma patients (75%), including patients previously treated with enfortumab vedotin and pembrolizumab Early antitumor activity also observed in squamous NSCLC, SCLC and prostate cancer SHANGHAI and HANGZHOU, China , Oct. 29, 2026 /PRNewswire/ -- Phrontline Biopharma, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs), today highlighted encouraging preliminary clinical results for TJ101 presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain, on October 23, 2026. The company also announced the initiation of Phase Ib, with the first patient dosed. TJ101 is an investigational bispecific ADC targeting EGFR and B7-H3, incorporating a topoisomerase I inhibitor payload. The ESMO presentation highlighted its emerging safety and tolerability pro preliminary antitumor activity across multiple advanced solid tumors. Among eight response-evaluable patients with urothelial carcinoma, six achieved partial responses (75%), including patients previously treated with enfortumab vedotin (EV) and pembrolizumab. Preliminary antitumor activity was also observed in other solid tumors, including squamous non-small cell lung cancer (sqNSCLC ) , small cell lung cancer (SCLC) and prostate cancer, supporting further clinical investigation across these indications. The emerging safety and tolerability findings support continued clinical evaluation, with ongoing dose escalation and exploration of alternative treatment schedules aimed at optimizing the therapeutic potential of TJ101. "We are encouraged by the emerging safety pro preliminary antitumor activity of TJ101, particularly in urothelial carcinoma and NSCLC," said Martín Sebastian Olivo, MD, MSc, Chief Medical Officer of Phrontline Biopharma . "The responses observed in patients previously treated with EV and pembrolizumab are especially promising as we continue to optimize dosing and treatment schedules." About TJ101 TJ101 is an investigational EGFR × B7-H3 bispecific ADC incorporating a topoisomerase I inhibitor payload. It is being evaluated in an ongoing global Phase I study in patients with advanced solid tumors. TJ101 has not been approved by any regulatory authority, and its safety and efficacy have not been established. About Phrontline Biopharma Phrontline Biopharma is a clinical-stage biotechnology company headquartered in Hangzhou, China, developing next-generation ADCs for solid tumors. Its proprietary platform combines bispecific antibody engineering, multiple payload mechanisms and branched dual-payload linker technology to address tumor heterogeneity and treatment resistance. For more information, visit . Forward-Looking Statements This release contains forward-looking statements regarding TJ101's clinical development and potential benefits. Actual results may differ materially due to risks inherent in drug development. Preliminary findings from limited patient numbers may not predict outcomes in subsequent studies. Phrontline undertakes no obligation to update these statements except as required by law. View original content: SOURCE Phrontline Biopharma