Secondary Central Nervous System Lymphoma

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.

-- At Median Follow-Up of 24.2 Months, No Additional Risks of Adverse Events Related to Yescarta Were Observed -- -- Findings Also Suggest Efficacy Trend with Median Progression-Free Survival and Durability of Response of More Than a Year -- -- Data Presented Orally at the 2024 American Society of Clinical Oncology Annual Meeting -- SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite Pharma, a Gilead Company (Nasdaq: GILD), announced data from a pilot study in collaboration with Dana-Farber Cancer Institute that demonstrate Yescarta® (axicabtagene ciloleucel) is well-tolerated in patients living with relapsed or refractory (R/R) primary or secondary central nervous system lymphoma (PCNSL and SCNSL). The findings, which also suggest a trend in efficacy, were presented today in an oral session (Abstract #2006) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Central nervous system lymphoma (CNSL) is an aggressive and rare form of non-Hodgkin lymphoma that has either originated in (primary) or spread to (secondary) the brain, eye, spinal cord or cerebrospinal fluid. The prognosis of PCNSL has historically been poor with a five-year survival rate of only 30%. More than half of the patients experience a relapse after front-line treatment, with a median survival of approximately two months. R/R CNSL is considered an area of unmet clinical need with no standard of care treatment options. “Patients with central nervous system involvement of large B-cell lymphoma were excluded from the studies that led to the FDA approval of axi-cel in relapsed/refractory large B-cell lymphoma,” said Lakshmi Nayak, MD, Associate Professor of Neurology, Harvard Medical School and Director of the Center for CNS Lymphoma, Dana-Farber Cancer Institute. “We conducted this pilot study to evaluate the safety of axi-cel in CNSL patients and to see if there would be a preliminary signal of efficacy. Not only did we see a high response rate with axi-cel in this heavily pre-treated population, but importantly they were durable. While we need more data to evaluate axi-cel in a larger study, these results are promising and represent a potential breakthrough in the treatment of this particularly rare and aggressive brain cancer for which there are limited options when it recurs.” In this pilot study of 18 patients with CNSL, at a median follow-up of 24.2 months, no treatment-limiting toxicities and no apparent additional risk of adverse events were reported. Immune effector cell-associated neurologic syndrome (ICANS) was observed among 44% of patients (27.8% Grade >3). The objective response rate was 94.4% and the complete response rate was 66.7%. The median time to best response was three months. The median duration of response was 13.4 months and 9 patients had progressed. At a median follow-up of 24 months, the median progression-free survival was 14.3 months (95% CI: 6.3-NR) and median overall survival was 26.4 months (95% CI: 11.2-NR). Ninety percent of patients developed grade 1 or 2 cytokine release syndrome; two patients developed Ommaya-related meningitis requiring explant with subsequent recovery. One patient developed grade 3 electrographic focal status epilepticus that resolved with anti-epileptic agents. Seven patients have died, all from disease progression. “We are very encouraged by the data presented today that indicate the potential to extend the benefits of Yescarta to people with relapsed/refractory primary and secondary central nervous system lymphoma, whose prognoses are typically very poor,” said Ibrahim Elhoussieny, MD, Vice President, Medical Affairs, Kite. “These early data support that CAR T-cell therapy may potentially offer a treatment option to these patients.” The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information. About Central Nervous System Lymphoma Central nervous system lymphoma (CNSL) is an aggressive and rare form of non-Hodgkin lymphoma that has either originated in (primary) or spread (secondary) to the brain, eye, spinal cord or cerebral spinal fluid. The prognosis of PCNSL has historically been poor with a five-year survival rate of only 30%. More than half of the patients experience a relapse, after which the average survival is approximately two months. R/R CNSL is considered an area of unmet clinical need with no standard of care treatment options. There is an estimated annual incidence of 1,500 cases of primary CNSL in the United States. Primary CNS comprises 3% of all primary brain tumors and 1% of all cases of non-Hodgkin lymphoma. CNSL is most likely to be seen in the elderly and people with a compromised immune system. About the Study The pilot study enrolled 18 patients (13 PCNSL, 4 SCNSL, 1 concurrent systemic and ocular lymphoma), of whom the first six patients were observed for treatment-limiting toxicities (TLTs). The primary endpoint was safety, measured by rate of TLTs and grade 3+ adverse events (AEs). Secondary endpoints included objective response rate, complete response rate, duration of response, progression-free survival and overall survival (OS). About Yescarta Please see full US Prescribing Information, including BOXED WARNING and Medication Guide. YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s). U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program. CYTOKINE RELEASE SYNDROME (CRS) CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities. Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. NEUROLOGIC TOXICITIES Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 days) and the median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred. The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41), and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset of and decrease the duration of CRS. Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly. REMS Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained in the management of CRS and neurologic toxicities. Further information is available at or 1-844-454-KITE (5483). HYPERSENSITIVITY REACTIONS Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA. SERIOUS INFECTIONS Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL; ≥ Grade 3 infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. PROLONGED CYTOPENIAS Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion. HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment. SECONDARY MALIGNANCIES Patients treated with YESCARTA may develop secondary malignancies. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including YESCARTA. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period. ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with an unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting. The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with an unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with an unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness. About Kite Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production, and commercial product manufacturing. 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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead acquired Kite in 2017. Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta (such as the foregoing pilot study); the possibility that Gilead and Kite may make a strategic decision to discontinue development of programs for indications that are currently under evaluation and, as a result, these programs may never be successfully commercialized for such indications; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, 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 Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. Kite, the Kite logo, Yescarta, and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies. For more information on Kite, please visit the company’s website at . Follow Kite on social media on X (@KitePharma) and LinkedIn.

Presented new case studies demonstrating clinical responses in two patients with B cell malignancies, chronic lymphocytic leukemia (CLL) and primary central nervous system lymphoma (PCNSL), each with central nervous system (CNS) involvement Data presented at the American Association for Cancer Research (AACR) 2024 Annual Meeting Brain activity highlights potential for broader application of NX-5948 in autoimmune disorders with CNS involvement SAN FRANCISCO, April 09, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of the first findings of clinical responses in the brain for NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses. The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement. These data were presented by Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, as part of the Major Symposium session Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances at the AACR 2024 Annual Meeting, which is being held from April 5-10, 2024, in San Diego, CA. “These data are the first demonstration of clinical activity in the brain of a targeted protein degrader, opening the door for new therapeutic strategies to treat leukemias and lymphomas with CNS involvement,” said Dr. Hansen. “The brain penetration of NX-5948 coupled with the clinical activity and safety profile presented to date, suggests a potential role in the treatment of B-cell lymphomas and chronic lymphocytic leukemia involving the CNS which are notoriously difficult to treat. It also suggests the potential to use NX-5948 as a therapeutic option for immune indications with CNS involvement such as multiple sclerosis.” Dr. Hansen’s presentation included new data from the dose escalation stage of Nurix’s Phase 1a/1b clinical trial evaluating daily oral dosing of BTK degrader NX-5948 in patients with relapsed or refractory B-cell malignancies. Data were presented demonstrating detection of NX-5948 in the cerebrospinal fluid (CSF) from all patients with available CSF samples. Case studies were presented for two of these patients. In one case study, a CLL patient was enrolled with secondary CNS involvement whose disease progressed following three prior lines of treatment, including both a BCL2 inhibitor in combination with rituximab and a BTK inhibitor (acalabrutinib). This patient, who presented with malignant cells in the CSF at study entry and the high-risk cytogenetic marker Del17p, received NX-5948 at a once daily dose of 100 mg. By week 8, the patient had significant lymph node reduction and spleen reduction consistent with stable disease. By week 16, the patient had experienced continued reduction in lymph nodes and spleen size and improvements in hematologic measures consistent with a partial response. By week 24, the partial response was confirmed and the patient no longer had measurable tumor cells in the CSF. As of March 4th, the patient remains on treatment in cycle 10 of therapy (>36 weeks). In the other case study, a patient was enrolled with primary central nervous system lymphoma (PCNSL) with the high-risk cytogenic marker of MYC rearrangement and whose disease progressed after two prior lines of therapy, including high dose multi-drug chemotherapy with rituximab in the first-line setting, and ibrutinib in the second line, which yielded a best response of stable disease. The patient presented with three measurable lesions in the right temporal lobe and received NX-5948 at the 450 mg once daily dose. By week 8, the patient experienced complete regression of all three lesions and demonstrated a complete response (CR). A subsequent 16 week scan revealed that this patient’s disease had progressed with the emergence of a new brain lesion. “These clinical responses seen to date with NX-5948 in patients with significant brain disease support future exploration of NX-5948 both as a single agent and in combination with other therapies that are used for primary and secondary CNS lymphoma and leukemia,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “The CLL patient with CNS involvement showed an impressive durable response with NX-5948 as single agent therapy in this setting. The patient with PCNSL, and an aggressive NHL histology, showed a rapid, complete response, providing clear evidence of therapeutic effect in the brain that has the potential to be augmented through combination therapies to improve durability of response.” About Central Nervous System (CNS) Lymphoma CNS involvement of B cell malignancies span various conditions including: Primary CNS lymphoma (PCNSL) comprising 4% of all primary CNS tumors and 4-6% of all extranodal lymphomas; secondary CNS lymphoma (SCNSL) which represents a risk of ~5% in patients with diffuse large B cell lymphoma (DLBLC); and CNS involvement in CLL which albeit rare, presents a poor prognosis in patients with clinically significant disease. About NX-5948 NX-5948 is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. NX-5948 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Nurix has previously reported that NX-5948 is highly potent against a range of tumor cell lines that are resistant to current BTK inhibitor therapies, an important consideration in heavily pretreated CLL/SLL patient populations. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022). About Nurix Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative small molecules and antibody therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer, inflammatory conditions, and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com. Forward-Looking Statements This press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurix’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding: Nurix’s plans and strategies with respect to NX-5948, including the future use of NX-5948 both as a single agent and in combination with other therapies, and the potential advantages and therapeutic benefits of NX-5948, including its potential role in the treatment B-cell lymphomas and CLL involving the CNS, its potential as a therapeutic option for immune indications with CNS involvement, and its potential when used in combination with other therapies. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix’s actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) the risks inherent in the drug development process, including the unexpected emergence of adverse events or other undesirable side effects during clinical development; (ii) uncertainties related to the timing and results of clinical trials; (iv) whether Nurix will be able to fund its research and development activities and achieve its research and development goals; (v) the impact of economic and market conditions and global and regional events on Nurix’s business, clinical trials, financial condition, liquidity and results of operations; (vi) whether Nurix will be able to protect intellectual property and (vii) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Annual Report on Form 10-K for the fiscal year ended November 30, 2023, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law. Contacts: InvestorsJason Kantor, Ph.D.Nurix Therapeuticsir@nurixtx.com Elizabeth Wolffe, Ph.D.Wheelhouse Life Science Advisorslwolffe@wheelhouselsa.com MediaAljanae ReynoldsWheelhouse Life Science Advisorsareynolds@wheelhouselsa.com