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FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) announced today its second quarter 2024 results of operations. “Gilead has had another strong quarter with 6% year-over-year growth in our base business. This was driven by sales of our therapies for HIV, Oncology and Liver Disease, including 8% growth for Biktarvy,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “One of the key highlights of the quarter was interim data from the Phase 3 PURPOSE 1 trial showing 100% efficacy for lenacapavir in HIV prevention for cisgender women. We look forward to additional clinical readouts in the coming months, and to potentially launching seladelpar for primary biliary cholangitis in the United States.” Second Quarter 2024 Financial Results Total second quarter 2024 revenue increased 5% to $7.0 billion, compared to the same period in 2023, primarily due to higher product sales in HIV, Liver Disease and Oncology. Diluted earnings per share (“EPS”) was $1.29 in the second quarter 2024, compared to $0.83 in the same period in 2023. The increase was primarily driven by lower operating expenses, including a 2023 expense of $525 million for settlements with certain plaintiffs in HIV antitrust litigation which did not repeat in 2024, as well as higher revenues and lower income tax expense, partially offset by higher net unrealized losses on equity securities. Non-GAAP diluted EPS was $2.01 in the second quarter 2024, compared to $1.34 in the same period in 2023. The increase was primarily driven by lower operating expenses and higher revenues. As of June 30, 2024, Gilead had $2.8 billion of cash, cash equivalents and marketable debt securities, compared to $8.4 billion as of December 31, 2023. The decrease primarily reflects the $3.9 billion acquisition of CymaBay Therapeutics, Inc. and a $1.75 billion repayment of senior notes. During the second quarter 2024, Gilead generated $1.3 billion in operating cash flow, net of a $1.2 billion transition tax payment associated with the Tax Cuts and Jobs Act of 2017. During the second quarter 2024, Gilead paid dividends of $972 million and repurchased $100 million of common stock. Second Quarter 2024 Product Sales Total second quarter 2024 product sales increased 5% to $6.9 billion, compared to the same period in 2023. Total product sales, excluding Veklury, increased 6% to $6.7 billion in the second quarter 2024, compared to the same period in 2023, primarily due to higher product sales in HIV, Liver Disease and Oncology. HIV product sales increased 3% to $4.7 billion in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand across treatment and prevention, partially offset by lower average realized price due to channel mix. Biktarvy ® (bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 8% to $3.2 billion in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand. Descovy® (FTC 200mg/TAF 25mg) sales decreased 6% to $485 million in the second quarter 2024, compared to the same period in 2023, primarily driven by lower average realized price due to channel mix, partially offset by higher demand. The Liver Disease portfolio sales increased 17% to $832 million in the second quarter 2024, compared to the same period in 2023. This was primarily driven by higher average realized price due to channel mix in the United States, as well as higher demand in products for chronic hepatitis C virus (“HCV”), chronic hepatitis B virus (“HBV”) and, in Europe, chronic hepatitis D virus (“HDV”). Veklury sales decreased 16% to $214 million in the second quarter 2024, compared to the same period in 2023, primarily driven by lower rates of COVID-19 related hospitalizations. Cell Therapy product sales increased 11% to $521 million in the second quarter 2024, compared to the same period in 2023. Yescarta® (axicabtagene ciloleucel) sales increased 9% to $414 million in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) outside the United States. Tecartus® (brexucabtagene autoleucel) sales increased 21% to $107 million in the second quarter 2024, compared to the same period in 2023, driven by higher demand in R/R mantle cell lymphoma and R/R adult acute lymphoblastic leukemia (“ALL”). Trodelvy® (sacituzumab govitecan-hziy) sales increased 23% to $320 million in the second quarter 2024, compared to the same period in 2023, primarily driven by higher demand in second-line metastatic triple negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer. Second Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 77.7% in the second quarter 2024, compared to 78.0% in the same period in 2023. Non-GAAP product gross margin was 86.0% in the second quarter 2024, compared to 86.9% in the same period in 2023. Research & development (“R&D”) expenses were $1.4 billion in the second quarter 2024 and in the same period in 2023. Non-GAAP R&D expenses were $1.3 billion in the second quarter 2024, compared to $1.4 billion in the same period in 2023. The changes were primarily driven by timing of clinical activities, including wind-down of studies. Acquired IPR&D expenses were $38 million in the second quarter 2024. Selling, general and administrative (“SG&A”) expenses and non-GAAP SG&A expenses were $1.4 billion in the second quarter 2024, compared to $1.8 billion in the same period in 2023. The decreases in GAAP and non-GAAP SG&A expenses were primarily driven by the 2023 legal settlement expense referenced earlier which did not repeat in 2024. The effective tax rate (“ETR”) was 21.4% in the second quarter 2024, compared to 34.6% in the same period in 2023. The decrease in ETR primarily reflects a remeasurement of certain deferred tax liabilities in the prior year and a settlement with a tax authority in the second quarter 2024. Non-GAAP ETR was 17.8% in the second quarter 2024, compared to 21.0% in the same period in 2023. The decrease in non-GAAP ETR primarily reflects a settlement with a tax authority. Guidance and Outlook For the full-year 2024, Gilead expects: (in millions, except per share amounts) August 8, 2024 Guidance Low End High End Comparison to April 25, 2024 Guidance Product sales $ 27,100 $ 27,500 Unchanged Product sales, excluding Veklury $ 25,800 $ 26,200 Unchanged Veklury $ 1,300 $ 1,300 Unchanged Diluted EPS $ 0.00 $ 0.30 Previously $0.10 to $0.50 Non-GAAP diluted EPS $ 3.60 $ 3.90 Previously $3.45 to $3.85 Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 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 Presented data from the Phase 3 PURPOSE 1 trial evaluating twice-yearly subcutaneous lenacapavir for HIV prevention in cisgender women at the International AIDS Conference (“AIDS 2024”). At the interim analysis, lenacapavir demonstrated 100% efficacy with zero HIV infections and superiority to both background HIV incidence and once-daily oral Truvada® (FTC 200mg and tenofovir disoproxil fumarate 300mg (“TDF”)). Lenacapavir was generally well-tolerated and no new safety concerns were identified. The use of lenacapavir for PrEP is investigational. Highlighted long-term, five-year data for Biktarvy at AIDS 2024, demonstrating virologic suppression in Hispanic/Latine people with HIV, as well as older adults with comorbidities. Additionally, presented results from Gilead’s investigational treatment pipeline, including 48-week data from the Phase 2 portion of the Phase 2/3 ARTISTRY study of once-daily oral bictegravir plus lenacapavir, once-weekly oral agents GS-1720 and GS-4182, as well as twice-yearly lenacapavir in combination with two broadly neutralizing antibodies, teropavimab and zinlirvimab. Announced U.S. Food and Drug Administration (“FDA”) approval of an updated label for Biktarvy to include additional data for the treatment of pregnant adults with HIV-1 with suppressed viral loads. Presented Phase 2b MYR201 data demonstrating potential for the investigational combination of bulevirtide 10 mg with pegylated interferon alfa-2a as finite therapy for people with chronic HDV at the European Association for the Study of the Liver (“EASL”) meeting. These data were simultaneously published in the New England Journal of Medicine . Presented 144-week follow-up data from the Phase 3 MYR301 study at EASL that reinforced bulevirtide as an efficacious and generally well-tolerated long-term treatment option as monotherapy in adults with chronic HDV. Bulevirtide 2 mg remains the only approved treatment for HDV in the EU and is not approved in the U.S. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally. Oncology Announced Trodelvy did not meet the primary endpoint of improvement in overall survival (“OS”) in the intention-to-treat (“ITT”) population of the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer. A numerical improvement in OS favoring Trodelvy was observed, in addition to trends in improvement for select pre-specified non-alpha controlled subgroups analyses and secondary endpoints of progression-free survival and overall response rate. In the ITT population, there was a higher number of deaths due to adverse events with Trodelvy compared to single-agent chemotherapy, which were primarily observed early in treatment and related to neutropenic complications, including infection. Presented detailed results from the Phase 3 EVOKE-01 study evaluating Trodelvy in patients with metastatic or advanced non-small cell lung cancer (“NSCLC”) that had progressed on or after platinum-based chemotherapy and anti-PD(L)1 therapy at the American Society of Clinical Oncology (“ASCO”) meeting. These data were simultaneously published in the Journal of Clinical Oncology . As announced in January 2024, EVOKE-01 did not meet its primary endpoint of overall survival. The use of Trodelvy for lung cancer is investigational. Provided a longer-term update on Cohort A of the Phase 2 EVOKE-02 study of Trodelvy in combination with pembrolizumab in first-line advanced or metastatic squamous or non-squamous PD-L1-high NSCLC at the ASCO meeting. Announced new data from a pilot study in collaboration with Dana-Farber Cancer Institute that evaluated the safety of Yescarta in patients living with R/R primary or secondary central nervous system lymphoma, an investigational use. This data was presented at the ASCO meeting. Presented updated, four-year OS data from the pivotal Phase 2 ZUMA-3 study evaluating Tecartus in adult patients with R/R B-cell ALL at the ASCO meeting. Presented updated analysis at the ASCO meeting from Arm A1 of the Phase 2 EDGE-Gastric study evaluating domvanalimab, zimberelimab (“zim”) and FOLFOX as a potential first-line treatment for upper gastrointestinal cancers, in partnership with Arcus Biosciences, Inc. (“Arcus”). Additionally, presented Phase 1b/2 ARC-9 Cohort B data with our partner Arcus, which is evaluating etrumadenant plus zim, FOLFOX and bevacizumab in third-line metastatic colorectal cancer. These products and uses are investigational. Announced preliminary findings at the European Hematology Association (“EHA”) meeting from the Phase 2 ZUMA-24 study suggesting outpatient administration of Yescarta is feasible. Additionally, presented real-world manufacturing experience analysis demonstrating a statistically significant higher number of R/R large B-cell lymphoma patients that received second-line treatment with Yescarta achieved first-pass manufacturing success compared to patients that received treatment with Yescarta in third-line and beyond. Announced key operational updates, together with Arcellx, Inc. (“Arcellx”), for the anitocabtagene autoleucel multiple myeloma development program, including the design of the Phase 3 iMMagine-3 trial as a second- to fourth-line treatment for multiple myeloma, as well as the completion of the technical transfer to Kite. Inflammation Presented two-year interim results from the ongoing long-term Phase 3 ASSURE study evaluating seladelpar in people living with primary biliary cholangitis (“PBC”) who participated in any prior seladelpar clinical study at the Digestive Diseases Week and EASL meetings. The data demonstrated a sustained and consistent long-term efficacy and safety profile for seladelpar in PBC. Seladelpar is an investigational product and is currently under review by FDA, with a PDUFA date of August 14, 2024. Entered into an amended license agreement featuring the buy-out of global seladelpar royalties from Janssen Pharmaceutica NV for $320 million. This transaction will be reflected in Gilead’s third quarter results. Corporate Announced Gilead reached a settlement agreement in principle in the federal TDF litigation in the U.S. District Court for the Northern District of California. The agreement, which is subject to certain conditions, provides that Gilead will make a one-time payment of up to $40 million and is expected to resolve the claims of the overwhelming majority of plaintiffs in the federal TDF litigation. Announced Chief Medical Officer Merdad Parsey, MD, PhD, will leave the company in the first quarter of 2025. A search is underway for his successor. The Board declared a quarterly dividend of $0.77 per share of common stock for the third quarter of 2024. The dividend is payable on September 27, 2024, to stock holders of record at the close of business on September 13, 2024. 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 http://investors.gilead.com and will be archived on www.gilead.com 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 and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. 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 and cancer. 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 anticipated full year 2024 financial results, including as a result of the uncertainty of the amount and timing of Veklury revenues; 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 and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the arrangements with Arcellx and Arcus; 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 Biktarvy, Trodelvy, Truvada, Yescarta, bevacizumab, bictegravir, bulevirtide, anitocabtagene autoleucel, domvanalimab, etrumadenant, GS-1720, GS-4182, lenacapavir, teropavimab, seladelpar, zimberelimab, and zinlirvimab (such as the ARTISTRY-1, ASSURE, EDGE-Gastric, EVOKE-01, EVOKE-02, iMMagine-3, MYR201, MYR301, PURPOSE-1, TROPiCS-04, ZUMA-3 and ZUMA-24 studies) , 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 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, including FDA approval of the New Drug Application for seladelpar, 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 (such as the risk that the FDA may not grant full approval or may withdraw its accelerated approval for Trodelvy for the treatment of locally advanced or metastatic urothelial cancer); 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 and may therefore be reluctant to prescribe the products, including Biktarvy; 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 June 30, 2024 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. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITE TM , AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, United States. Other trademarks are the property of their respective owners. For more information on Gilead Sciences, Inc., please visit www.gilead.com 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 Six Months Ended June 30, June 30, (in millions, except per share amounts) 2024 2023 2024 2023 Revenues: Product sales $ 6,912 $ 6,564 $ 13,559 $ 12,870 Royalty, contract and other revenues 41 35 81 81 Total revenues 6,954 6,599 13,640 12,951 Costs and expenses: Cost of goods sold 1,544 1,442 3,096 2,843 Research and development expenses 1,351 1,407 2,871 2,854 Acquired in-process research and development expenses 38 236 4,169 717 In-process research and development impairment — — 2,430 — Selling, general and administrative expenses 1,377 1,849 2,752 3,168 Total costs and expenses 4,309 4,934 15,317 9,581 Operating income (loss) 2,644 1,665 (1,678 ) 3,370 Interest expense 237 230 491 459 Other (income) expense, net 355 (152 ) 265 22 Income (loss) before income taxes 2,053 1,588 (2,433 ) 2,888 Income tax expense 438 549 123 865 Net income (loss) 1,614 1,039 (2,556 ) 2,024 Net loss attributable to noncontrolling interest — (6 ) — (32 ) Net income (loss) attributable to Gilead $ 1,614 $ 1,045 $ (2,556 ) $ 2,055 Basic earnings (loss) per share attributable to Gilead $ 1.29 $ 0.84 $ (2.05 ) $ 1.65 Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,247 1,249 1,247 1,249 Diluted earnings (loss) per share attributable to Gilead $ 1.29 $ 0.83 $ (2.05 ) $ 1.63 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,251 1,258 1,247 1,260 Supplemental Information: Cash dividends declared per share $ 0.77 $ 0.75 $ 1.54 $ 1.50 Product gross margin 77.7 % 78.0 % 77.2 % 77.9 % Research and development expenses as a % of revenues 19.4 % 21.3 % 21.0 % 22.0 % Selling, general and administrative expenses as a % of revenues 19.8 % 28.0 % 20.2 % 24.5 % Operating margin 38.0 % 25.2 % (12.3 )% 26.0 % Effective tax rate 21.4 % 34.6 % (5.1 )% 29.9 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Product sales: HIV $ 4,745 $ 4,626 3 % $ 9,088 $ 8,816 3 % Liver Disease 832 711 17 % 1,569 1,386 13 % Oncology 841 728 15 % 1,629 1,398 17 % Other 280 243 15 % 504 442 14 % Total product sales excluding Veklury 6,698 6,308 6 % 12,790 12,041 6 % Veklury 214 256 (16 )% 769 829 (7 )% Total product sales 6,912 6,564 5 % 13,559 12,870 5 % Royalty, contract and other revenues 41 35 18 % 81 81 (1 )% Total revenues $ 6,954 $ 6,599 5 % $ 13,640 $ 12,951 5 % GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION (1) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Non-GAAP: Cost of goods sold $ 965 $ 861 12% $ 1,939 $ 1,732 12% Research and development expenses $ 1,335 $ 1,377 (3)% $ 2,738 $ 2,816 (3)% Acquired IPR&D expenses (2) $ 38 $ 236 (84)% $ 4,169 $ 717 NM Selling, general and administrative expenses $ 1,351 $ 1,848 (27)% $ 2,646 $ 3,166 (16)% Other (income) expense, net $ (37 ) $ (83 ) (56)% $ (141 ) $ (165 ) (15)% Diluted earnings per share attributable to Gilead $ 2.01 $ 1.34 50% $ 0.70 $ 2.71 (74)% Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,251 1,258 (1)% 1,254 1,260 —% Product gross margin 86.0 % 86.9 % -84 bps 85.7 % 86.5 % -84 bps Research and development expenses as a % of revenues 19.2 % 20.9 % -167 bps 20.1 % 21.7 % -167 bps Selling, general and administrative expenses as a % of revenues 19.4 % 28.0 % -857 bps 19.4 % 24.4 % -504 bps Operating margin 47.0 % 34.5 % NM 15.7 % 34.9 % NM Effective tax rate 17.8 % 21.0 % -322 bps 51.4 % 20.0 % NM ________________________________ NM - Not Meaningful (1) Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables below. (2) Equal to GAAP financial information. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,544 $ 1,442 $ 3,096 $ 2,843 Acquisition-related – amortization (1) (579 ) (581 ) (1,158 ) (1,110 ) Restructuring — — 1 — Non-GAAP cost of goods sold $ 965 $ 861 $ 1,939 $ 1,732 Product gross margin reconciliation: GAAP product gross margin 77.7 % 78.0 % 77.2 % 77.9 % Acquisition-related – amortization (1) 8.4 % 8.8 % 8.5 % 8.6 % Restructuring (— )% — % (— )% — % Non-GAAP product gross margin 86.0 % 86.9 % 85.7 % 86.5 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,351 $ 1,407 $ 2,871 $ 2,854 Acquisition-related – other costs (2) (3 ) (30 ) (70 ) (38 ) Restructuring (13 ) — (63 ) — Non-GAAP research and development expenses $ 1,335 $ 1,377 $ 2,738 $ 2,816 IPR&D impairment reconciliation: GAAP IPR&D impairment $ — $ — $ 2,430 $ — IPR&D impairment — — (2,430 ) — Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,377 $ 1,849 $ 2,752 $ 3,168 Acquisition-related – other costs (2) (17 ) (1 ) (84 ) (2 ) Restructuring (8 ) — (22 ) — Non-GAAP selling, general and administrative expenses $ 1,351 $ 1,848 $ 2,646 $ 3,166 Operating income (loss) reconciliation: GAAP operating income (loss) $ 2,644 $ 1,665 $ (1,678 ) $ 3,370 Acquisition-related – amortization (1) 579 581 1,158 1,110 Acquisition-related – other costs (2) 21 31 153 40 Restructuring 21 — 84 — IPR&D impairment — — 2,430 — Non-GAAP operating income $ 3,265 $ 2,277 $ 2,148 $ 4,521 Operating margin reconciliation: GAAP operating margin 38.0 % 25.2 % (12.3 )% 26.0 % Acquisition-related – amortization (1) 8.3 % 8.8 % 8.5 % 8.6 % Acquisition-related – other costs (2) 0.3 % 0.5 % 1.1 % 0.3 % Restructuring 0.3 % — % 0.6 % — % IPR&D impairment — % — % 17.8 % — % Non-GAAP operating margin 47.0 % 34.5 % 15.7 % 34.9 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ 355 $ (152 ) $ 265 $ 22 (Loss) gain from equity securities, net (392 ) 69 (405 ) (187 ) Non-GAAP other (income) expense, net $ (37 ) $ (83 ) $ (141 ) $ (165 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 2,053 $ 1,588 $ (2,433 ) $ 2,888 Acquisition-related – amortization (1) 579 581 1,158 1,110 Acquisition-related – other costs (2) 21 31 153 40 Restructuring 21 — 84 — IPR&D impairment — — 2,430 — Loss (gain) from equity securities, net 392 (69 ) 405 187 Non-GAAP income before income taxes $ 3,065 $ 2,131 $ 1,798 $ 4,226 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Income tax expense reconciliation: GAAP income tax expense $ 438 $ 549 $ 123 $ 865 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization (1) 121 120 242 227 Acquisition-related – other costs (2) 7 5 37 8 Restructuring 7 — 16 — IPR&D impairment — — 611 — Loss (gain) from equity securities, net 33 1 (6 ) 1 Discrete and related tax charges (3) (60 ) (227 ) (100 ) (256 ) Non-GAAP income tax expense $ 546 $ 448 $ 923 $ 844 Effective tax rate reconciliation: GAAP effective tax rate 21.4 % 34.6 % (5.1 )% 29.9 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments (3) (3.5 )% (13.5 )% 56.4 % (10.0 )% Non-GAAP effective tax rate 17.8 % 21.0 % 51.4 % 20.0 % Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 1,614 $ 1,045 $ (2,556 ) $ 2,055 Acquisition-related – amortization (1) 458 461 916 884 Acquisition-related – other costs (2) 14 26 117 32 Restructuring 14 — 68 — IPR&D impairment — — 1,819 — Loss (gain) from equity securities, net 359 (70 ) 412 187 Discrete and related tax charges (3) 60 227 100 256 Non-GAAP net income attributable to Gilead $ 2,519 $ 1,688 $ 874 $ 3,414 Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 1.29 $ 0.83 $ (2.05 ) $ 1.63 Acquisition-related – amortization (1) 0.37 0.37 0.73 0.70 Acquisition-related – other costs (2) 0.01 0.02 0.09 0.03 Restructuring 0.01 — 0.05 — IPR&D impairment — — 1.46 — Loss (gain) from equity securities, net 0.29 (0.06 ) 0.33 0.15 Discrete and related tax charges (3) 0.05 0.18 0.08 0.20 Non-GAAP diluted earnings per share $ 2.01 $ 1.34 $ 0.70 $ 2.71 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 581 $ 1,157 $ 1,110 Research and development expenses adjustments 16 30 133 38 IPR&D impairment adjustments — — 2,430 — Selling, general and administrative expenses adjustments 26 1 106 2 Total non-GAAP adjustments to costs and expenses 620 612 3,826 1,150 Other (income) expense, net adjustments 392 (69 ) 405 187 Total non-GAAP adjustments before income taxes 1,012 543 4,231 1,338 Income tax effect of non-GAAP adjustments above (168 ) (126 ) (900 ) (235 ) Discrete and related tax charges (3) 60 227 100 256 Total non-GAAP adjustments to net income attributable to Gilead $ 905 $ 644 $ 3,431 $ 1,358 ______________________________ (1) Relates to amortization of acquired intangibles. (2) Adjustments include integration expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s acquisitions of MYR GmbH, MiroBio, Ltd., Tmunity Therapeutics, Inc., XinThera, Inc. and CymaBay Therapeutics, Inc. (3) Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2024 FULL-YEAR GUIDANCE (1) (unaudited) (in millions, except percentages and per share amounts) Provided February 6, 2024 Updated April 25, 2024 Updated August 8, 2024 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 76.0% - 77.0% 76.0% - 77.0% 76.0% - 77.0% Acquisition-related expenses and restructuring expenses ~ 9.0% ~ 9.0% ~ 9.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $8,700 - $9,200 $1,900 - $2,400 $2,100 - $2,500 IPR&D impairment, acquisition-related and restructuring expenses ~ 2,500 ~ 5,100 ~ 5,100 Non-GAAP projected operating income $11,200 - $11,700 $7,000 - $7,500 $7,200 - $7,600 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 21% ~ 65% ~ 87% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 2%) (~ 35%) (~ 57%) Non-GAAP projected effective tax rate ~ 19% ~ 30% ~ 30% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.15 - $5.55 $0.10 - $0.50 $0.00 - $0.30 IPR&D impairment, acquisition-related and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments ~ 1.70 ~ 3.35 ~ 3.60 Non-GAAP projected diluted EPS $6.85 - $7.25 $3.45 - $3.85 $3.60 - $3.90 ________________________________ (1) Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) June 30, December 31, (in millions) 2024 2023 Assets Cash, cash equivalents and marketable debt securities $ 2,772 $ 8,428 Accounts receivable, net 4,663 4,660 Inventories 3,388 3,366 Property, plant and equipment, net 5,346 5,317 Intangible assets, net 22,832 26,454 Goodwill 8,314 8,314 Other assets 6,265 5,586 Total assets $ 53,579 $ 62,125 Liabilities and Stockholders’ Equity Current liabilities $ 10,781 $ 11,280 Long-term liabilities 24,602 28,096 Stockholders’ equity (1) 18,197 22,749 Total liabilities and stockholders’ equity $ 53,579 $ 62,125 ________________________________ (1) As of June 30, 2024 and December 31, 2023, there were 1,246 shares of common stock issued and outstanding. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 1,325 $ 2,337 $ 3,544 $ 4,082 Net cash used in investing activities (307 ) (483 ) (2,514 ) (1,309 ) Net cash used in financing activities (2,953 ) (1,101 ) (4,314 ) (2,507 ) Effect of exchange rate changes on cash and cash equivalents (11 ) 14 (29 ) 26 Net change in cash and cash equivalents (1,947 ) 768 (3,313 ) 292 Cash and cash equivalents at beginning of period 4,718 4,936 6,085 5,412 Cash and cash equivalents at end of period $ 2,772 $ 5,704 $ 2,772 $ 5,704 Three Months Ended Six Months Ended June 30, June 30, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 1,325 $ 2,337 $ 3,544 $ 4,082 Capital expenditures (130 ) (139 ) (235 ) (248 ) Free cash flow (1) $ 1,195 $ 2,199 $ 3,309 $ 3,834 ________________________________ (1) Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above. GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2024 2023 2024 2023 HIV Biktarvy – U.S. $ 2,585 $ 2,439 $ 4,900 $ 4,600 Biktarvy – Europe 370 302 735 606 Biktarvy – Rest of World 277 237 542 449 3,232 2,979 6,177 5,656 Descovy – U.S. 434 460 805 855 Descovy – Europe 25 25 51 50 Descovy – Rest of World 26 31 55 60 485 516 911 965 Genvoya – U.S. 372 455 704 872 Genvoya – Europe 45 56 95 111 Genvoya – Rest of World 23 29 44 58 440 540 843 1,041 Odefsey – U.S. 233 267 457 497 Odefsey – Europe 72 74 148 149 Odefsey – Rest of World 10 11 21 22 315 351 626 668 Symtuza - Revenue share (1) – U.S. 131 84 236 182 Symtuza - Revenue share (1) – Europe 34 33 67 70 Symtuza - Revenue share (1) – Rest of World 3 3 6 7 168 120 309 259 Other HIV (2) – U.S. 65 74 125 136 Other HIV (2) – Europe 25 31 70 63 Other HIV (2) – Rest of World 15 15 27 28 105 120 222 228 Total HIV – U.S. 3,821 3,778 7,226 7,142 Total HIV – Europe 571 521 1,167 1,049 Total HIV – Rest of World 353 326 695 624 4,745 4,626 9,088 8,816 Liver Disease Sofosbuvir / Velpatasvir (3) – U.S. 267 223 515 427 Sofosbuvir / Velpatasvir (3) – Europe 84 84 163 174 Sofosbuvir / Velpatasvir (3) – Rest of World 126 90 203 181 476 397 881 782 Vemlidy – U.S. 117 96 212 183 Vemlidy – Europe 11 10 22 19 Vemlidy – Rest of World 115 113 233 216 243 219 467 418 Other Liver Disease (4) – U.S. 47 37 89 64 Other Liver Disease (4) – Europe 47 37 94 78 Other Liver Disease (4) – Rest of World 19 21 38 44 113 95 221 186 Total Liver Disease – U.S. 431 356 816 674 Total Liver Disease – Europe 142 131 279 271 Total Liver Disease – Rest of World 259 225 474 441 832 711 1,569 1,386 Veklury Veklury – U.S. 76 97 391 349 Veklury – Europe 53 52 123 163 Veklury – Rest of World 85 107 255 317 214 256 769 829 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2024 2023 2024 2023 Oncology Cell Therapy Tecartus – U.S. 63 56 118 114 Tecartus – Europe 37 29 73 56 Tecartus – Rest of World 7 4 16 6 107 88 207 177 Yescarta – U.S. 186 217 357 427 Yescarta – Europe 169 133 327 254 Yescarta – Rest of World 58 30 110 58 414 380 794 739 Total Cell Therapy – U.S. 250 272 475 542 Total Cell Therapy – Europe 206 162 400 310 Total Cell Therapy – Rest of World 66 34 126 65 521 469 1,001 916 Trodelvy Trodelvy – U.S. 224 189 429 351 Trodelvy – Europe 69 53 137 107 Trodelvy – Rest of World 26 17 62 23 320 260 628 482 Total Oncology – U.S. 474 462 904 893 Total Oncology – Europe 275 215 537 417 Total Oncology – Rest of World 92 51 188 88 841 728 1,629 1,398 Other AmBisome – U.S. 17 20 31 27 AmBisome – Europe 69 69 139 129 AmBisome – Rest of World 65 61 124 111 151 151 294 267 Other (5) – U.S. 98 64 156 127 Other (5) – Europe 8 10 18 22 Other (5) – Rest of World 24 17 36 26 130 92 209 175 Total Other – U.S. 115 85 188 153 Total Other – Europe 77 80 156 152 Total Other – Rest of World 88 78 160 137 280 243 504 442 Total product sales – U.S. 4,916 4,777 9,525 9,211 Total product sales – Europe 1,118 999 2,262 2,052 Total product sales – Rest of World 878 788 1,772 1,607 $ 6,912 $ 6,564 $ 13,559 $ 12,870 ______________________________ (1) Represents Gilead’s revenue from cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company. (2) Includes Atripla, Complera/Eviplera, Emtriva, Sunlenca, Stribild, Truvada and Tybost. (3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”). (4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig.

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced data from a planned interim analysis of the LATITUDE phase III trial, indicating that their long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva (cabotegravir + rilpivirine), demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy in individuals with a history of ART adherence challenges. The data were presented by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) network at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) , in Denver, Colorado. Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, said: “It’s estimated that one-third of people living with HIV in the United States struggle with maintaining viral suppression. The findings of the LATITUDE study show that long-acting injectable cabotegravir + rilpivirine could be important for some people in this group, giving them another option to help keep their virus under control and improve their health. Further, since we know that individuals whose virus is undetectable don’t transmit to sexual partners, this could be an important contribution to ending the HIV epidemic.” LATITUDE is a phase III, randomised, open-label study. Participants received comprehensive and incentivised adherence support while taking guideline-recommended, three-drug regimen oral ART, including dolutegravir and bictegravir-based regimens, to achieve viral suppression. Those who achieved viral suppression were eligible to randomise to staying on oral standard of care (SOC) regimens or switch to long-acting injectable cabotegravir + rilpivirine (LA-ART) dosed monthly. During the randomised phase of the study, 146 participants received monthly LA-ART and 148 continued on SOC. The primary endpoint was a comparison of regimen failure, defined as a combination of virologic failures (VF) and regimen discontinuations, between arms. 24.1% of participants on LA-ART experienced regimen failure compared to 38.5% on SOC {difference -14.4 (98.75% CI–29.8%, -0.8%)}. Although the primary endpoint did not meet the strict predefined stopping criterion for the interim analysis, key secondary endpoints of virologic failure (7.2% LA-ART vs. 25.4% SOC {difference -18.2% (98.75% CI-31.1%, -5.4%}) and treatment-related failure (9.6% LA-ART vs. 26.2% SOC {difference -16.6% (98.75% CI-29.9%, -3.3%)} favoured the LA-ART regimen. The study’s Data Safety Monitoring Board (DSMB) considered the totality of all the study endpoints together and concluded that the evidence indicated superior efficacy of long-acting ART over daily oral standard of care. The DSMB recommended that all eligible participants should be offered long-acting injectable cabotegravir + rilpivirine. The rate of adverse events (AEs) was similar in both arms. Three participants in the LA-ART arm had serious injection site reactions (ISR) and one participant discontinued due to an ISR. Two confirmed virologic failures in each arm had new resistance associated mutations (RAMS), including at least two new integrase inhibitor RAMs in both LA-ART participants. The LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) study is ongoing across 31 sites in the U.S. including Puerto Rico, implemented through ACTG. The median age of study participants was 40 years old; 40 percent of participants were male, 64 percent were Black/African American, 17 percent were Hispanic, 5 percent were transgender, and 14 percent currently or previously used injection drugs. The study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is being conducted by ACTG, with additional support from the National Institute of Mental Health, the National Institute on Drug Abuse, ViiV Healthcare and the Janssen Pharmaceutical Companies of Johnson & Johnson. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the US as a 25mg tablet taken once a day to treat HIV-1 in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35kg with a viral load ≤100,000 HIV RNA c/ml. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Please consult the full Prescribing Information. CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions Professional Indication and Important Safety Information INDICATION CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction Post-Injection Reactions: Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection Carefully follow the Instructions for Use when preparing and administering CABENUVA . The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated Hepatotoxicity: Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected Depressive Disorders: Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products Promptly evaluate patients with depressive symptoms Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions) Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes Long-Acting Properties and Potential Associated Risks with CABENUVA : Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible ADVERSE REACTIONS The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash The safety of CABENUVA in adolescents is expected to be similar to adults DRUG INTERACTIONS Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine) Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes USE IN SPECIFIC POPULATIONS Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA . An Antiretroviral Pregnancy Registry has been established Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at hundreds of locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in the company's Annual Report on Form 20-F for 2023. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: GSK plc 980 Great West Road Brentford, Middlesex United Kingdom TW8 9GS ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY

26 十月 2023 万凯锐®和瑞卡必®在中国获批作为HIV-1长效注射治疗方案联合使用 今日，葛兰素史克（以下简称“GSK”）宣布，其HIV药物专研合资公司ViiV Healthcare（以下简称“ViiV”）产品万凯锐 ® （通用名称：卡替拉韦注射液）与强生旗下杨森制药有限公司产品瑞卡必 ® （通用名称：利匹韦林注射液）已获得中国国家药品监督管理局（NMPA）批准联合使用，用于治疗已达到病毒学抑制的HIV-1感染者。卡替拉韦片剂也被批准与利匹韦林片剂联用，可选择作为注射疗法开始前口服导入用药，或作为未按计划进行注射治疗者的口服治疗方案。欧洲药品管理局（EMA）在2020年10月16日官方新闻稿中指出，它是首个HIV长效注射治疗方案，可代替每日口服药物，实现每月或每两月给药一次 [1] 。它同时也是中国国家药品监督管理局批准的首个完整的HIV-1长效（最长每两个月一次）注射治疗方案。 副总裁、GSK中国总经理齐欣女士表示：“‘不放弃任何一位HIV感染者’是我们不变的使命。作为HIV-1长效注射方案，万凯锐 ® 和瑞卡必 ® 在华获批使中国HIV感染者的用药频率从每日服药减少为最少每两月一次，为中国HIV感染者提供了全新的治疗选择。GSK致力于引入业界领先的HIV创新解决方案，满足中国HIV感染者不断变化的需求，也期待与各界紧密合作，提升长效注射方案可及性，惠及中国HIV感染者。” 2022年，全球约有2980万HIV感染者正在接受抗逆转录病毒治疗（ART） [2] 。经过人类40余年的抗争，HIV感染已不再是不治之症。截至2022年底，中国报告存活HIV/AIDS 122.3万例 [3] ，整体持续处于低流行水平。 “四免一关怀”政策的实施及抗逆转录病毒治疗的广泛普及，极大地推动了我国HIV的防控进程，目前HIV感染者的治疗覆盖率和成功率均已超过90% [4] 。中国疾病预防控制中心性病艾滋病预防控制中心主任韩孟杰研究员指出：“下一阶段的艾滋病防治工作应围绕巩固已有的防治成果，针对防治的重点和难点，精准施策，创新实施 [5] 。”HIV-1长效治疗方案可以提升HIV感染者用药依从性，有助于控制感染和减少传播，助力 “2030年前终结艾滋病对公共卫生的威胁” 目标的实现，同时为HIV感染者提供新的治疗方案选择，以满足新的治疗需求。 广州医科大学附属市八医院国家临床重点专科首席专家蔡卫平教授表示：“研究表明，HIV感染者普遍面临每日服药的挑战 [5] , [6] , [7], [8] 。每日服药时刻提醒着感染者自身携带HIV病毒，担忧其暴露HIV感染者身份以及依从性焦虑。患者偏好数据显示，相较于每日口服方案，98%的受试者更倾向于接受每两个月注射一次的长效治疗方案 [9] 。万凯锐 ® 和瑞卡必 ® 作为首个完整的长效治疗方案，只需最少每两个月注射一次，明显减少了HIV感染者的用药次数，有助于改善治疗体验从而提高生活质量。” 此次获批基于三项关键性研究数据：III期ATLAS（Antiretroviral Therapy as Long-Acting Suppression）和FLAIR（First Long-Acting Injectable Regimen）研究，以及IIIb期ATLAS-2M研究，共计招募了来自16个国家的1200多名研究对象。ATLAS和FLAIR研究证明了卡替拉韦和利匹韦林联合治疗方案相对于标准口服治疗方案的有效性和耐受性，其中ATLAS-2M研究证明每两个月进行一次长效治疗的疗效与每月接受一次治疗相当 [10] , [11] , [12] 。在ATLAS研究中，92.5%接受长效治疗的受试者和95.5%接受口服治疗的受试者在第48周仍保持病毒学抑制（调整后的差值：-0.3%；95%置信区间，-6.7%-0.7%），满足非劣效性标准 [10] 。在FLAIR研究中，93.6%接受长效治疗的受试者和93.3%接受口服治疗的受试者在第48周仍保持病毒学抑制（调整后的差值：0.4%；95%置信区间，-3.7%-4.5%），满足非劣效性标准 [13] 。在ATLAS-2M研究中， 48周治疗后，每8周接受一次卡替拉韦与利匹韦林长效疗法不劣效于每4周接受一次治疗的疗效（调整差值：0.8%，95%置信区间【CI】：-0.6%，2.2%） [13] 。 关于卡替拉韦 卡替拉韦是由ViiV Healthcare开发的一种整合酶链转移抑制剂（INSTI），用于接受稳定抗逆转录病毒方案治疗后已达病毒学抑制的成人HIV-1感染者，其被批准作为长效制剂与利匹韦林注射液联合使用。 INSTIs通过防止病毒DNA与人类免疫细胞（T细胞）的遗传物质整合，从而抑制HIV的复制。这一步在HIV复制周期中至关重要，也是造成其成为慢性病的原因。 卡替拉韦注射液及卡替拉韦钠片已于2023年7月11日正式获得中国国家药品监督管理局批准，联合利匹韦林注射液和利匹韦林片剂使用，用于治疗已达到病毒学抑制的HIV-1感染者。 关于利匹韦林片剂和利匹韦林注射液 利匹韦林是一种非核苷逆转录酶抑制剂（NNRTI），通过干扰逆转录酶发挥作用，这种酶能够阻止病毒复制。利匹韦林片剂被批准与其他抗逆转录病毒药物联合使用，用于体重不低于35公斤且病毒载量≤100,000 HIV RNA copies/ml，年满12岁及以上的抗逆转录病毒治疗初治患者进行HIV-1治疗。 利匹韦林注射液是一种用于肌肉注射的长效注射液，由Janssen Sciences Ireland Unlimited Company开发。利匹韦林注射液于2023年10月18日在中国获批上市。 关于卡替拉韦和利匹韦林的用法和剂量 卡替拉韦注射液与利匹韦林注射液的联合使用是一种完整的长效治疗方案，适用于已达病毒学抑制的HIV-1感染者，每月一次或每两个月给药一次。卡替拉韦和利匹韦林注射液由医护人员在同一时间以两次臀部肌肉注射（IM）的方式给药。在开始注射前，使用者可选择服用卡替拉韦和利匹韦林口服片剂约一个月（至少28天），以评估药物的耐受性。 对于每月一次注射，与利匹韦林注射液联合使用时，卡替拉韦注射液的成人首次注射剂量通常为600 mg，在臀部肌肉注射给药。此后的每个月应通过臀部肌肉持续注射给药400 mg。对于每两个月一次注射，卡替拉韦注射液通常成人的首次注射剂量为600 mg，在臀部肌肉注射给药。首次注射卡替拉韦的一个月后，应在臀部肌肉注射给药600 mg。此后，每两个月在臀部肌肉持续注射给药600 mg。 * 关于卡替拉韦和利匹韦林产品适应症及用法用量，详见卡替拉韦和利匹韦林中国获批产品说明书 [13] , [14] 。 关于葛兰素史克 葛兰素史克（GSK）是一家以“汇聚科学、技术与人才，合力超越，共克疾病”为使命的全球生物医药公司。如需更多信息，请访问 gsk.com 。 关于 ViiV Healthcare ViiV Healthcare是由葛兰素史克（LSE：GSK）和辉瑞（NYSE：PFE）于2009年11月合资建立的一家HIV药物专研跨国公司。该公司致力于为携带人类免疫缺陷病毒（HIV）和有HIV感染风险的人群提供先进的治疗和护理。盐野义制药于2012年10月加入，成为公司股东之一。公司旨在以行业领先的深度和广度研究HIV/艾滋病 ，以新的方式带来治疗和预防HIV感染的有效创新药物，并为受到HIV/艾滋病影响的人群提供支持。 有关公司及其管理、产品组合、在研产品和承诺，请访问www.viivhealthcare.com 参考资料 [1] https://www.ema.europa.eu/en/news/first-long-acting-injectable-antiretroviral-therapy-hiv-recommended-approval [2] https://www.unaids.org/en/resources/fact-sheet [3] 中国疾病预防控制中心（CCDC）.  韩孟杰; 《中国艾滋病性病》; 2023;29;247-250. [4] https://www.thepaper.cn/newsDetail_forward_23577919 [5] Changing Perceptions: Talking About HIV and Attitude. Positive Voices Survey, Nov 2018. Available at: https://www.nat.org.uk/sites/default/files/publications/web_PV_Changing%20PerceptionsStigma-report.pdf (accessed Jan 2021) [6] Katz IT, et al. J Int AIDS Soc 2013;16(Suppl 2):18640 [7] Muessig KE, et al. AIDS Patient Care STDs 2015;29:606–16 [8] Mantsios A, et al. IDWeek 2019. Poster 2497. [9] Chounta, Vasiliki et al. “Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M).” The patient, 10.1007/s40271-021-00524-0. 31 May. 2021, doi:10.1007/s40271-021-00524-0 [10] Swindells S, Andrade-Villanueva J-F, Richmond G, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. New England Journal of Medicine 2020; 382:1112-1123. [11] Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. New England Journal of Medicine 2020; 382:1124-1135. [12] Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. The Lancet 2020 ; 396(10267):1994-2005 [13] 卡替拉韦钠片（万凯锐）及卡替拉韦注射液（万凯锐）中国获批说明书 [14] 利匹韦林片（恩临）及利匹韦林注射液中国获批说明书