Plasmacytoma

Product Sales Excluding Veklury Increased Year-Over-Year by 7% for Full Year 2023 Biktarvy Sales Increased Year-Over-Year by 14% for Full Year 2023 Oncology Sales Increased Year-Over-Year by 37% for Full Year 2023 FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2023. “This was another strong year of revenue growth for Gilead’s base business, driven by both HIV and Oncology,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “The strength of the business provides a solid foundation as we enter a new catalyst-rich phase for the company. We are expecting several milestones in 2024, including updates on long-acting HIV prevention and treatment, Cell Therapy and Trodelvy.” Fourth Quarter 2023 Financial Results Total fourth quarter 2023 revenue decreased 4% to $7.1 billion compared to the same period in 2022, primarily due to lower Veklury® (remdesivir) and HIV sales, partially offset by higher Oncology sales. Diluted Earnings Per Share (“EPS”) decreased to $1.14 in the fourth quarter 2023 compared to $1.30 in the same period in 2022, primarily due to higher total costs and expenses, and lower Veklury revenues, partially offset by unrealized gains on equity investments in 2023 compared to losses in 2022, and lower tax expense. Non-GAAP diluted EPS increased to $1.72 in the fourth quarter 2023 compared to $1.67 in the same period in 2022, primarily due to lower total costs and expenses, partially offset by lower Veklury revenues. As of December 31, 2023, Gilead had $8.4 billion of cash, cash equivalents and marketable debt securities compared to $7.6 billion as of December 31, 2022. During the fourth quarter 2023, Gilead generated $2.2 billion in operating cash flow. During the fourth quarter 2023, Gilead paid cash dividends of $943 million and utilized $150 million to repurchase common stock. Fourth Quarter 2023 Product Sales Total fourth quarter 2023 product sales decreased 4% to $7.1 billion compared to the same period in 2022. Total product sales, excluding Veklury, of $6.3 billion were flat compared to the same period in 2022, with higher Oncology sales partially offset by lower HIV sales. HIV product sales decreased 2% to $4.7 billion in the fourth quarter 2023 compared to the same period in 2022, primarily driven by lower average realized price due to channel mix, partially offset by higher demand and channel inventory dynamics. Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 7% to $3.1 billion in the fourth quarter 2023 compared to the same period in 2022, primarily reflecting higher demand, partially offset by lower average realized price due to channel mix. Descovy® (FTC 200mg/TAF 25mg) sales decreased 5% to $509 million in the fourth quarter 2023 compared to the same period in 2022, primarily driven by unfavorable pricing dynamics in the United States, partially offset by higher demand and channel inventory dynamics. The Liver Disease portfolio sales were $691 million in the fourth quarter 2023 and remained flat compared to the same period in 2022. Sales were impacted by unfavorable pricing dynamics, offset by higher demand across chronic hepatitis C virus (“HCV”) and chronic hepatitis delta virus (“HDV”) products. Cell Therapy product sales increased 11% to $466 million in the fourth quarter 2023 compared to the same period in 2022. Yescarta® (axicabtagene ciloleucel) sales increased 9% to $368 million in the fourth quarter 2023 compared to the same period in 2022, primarily driven by strong demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) outside the United States. Tecartus® (brexucabtagene autoleucel) sales increased 19% to $98 million in the fourth quarter 2023 compared to the same period in 2022, driven by increased demand in R/R adult acute lymphoblastic leukemia (“ALL”) and in R/R mantle cell lymphoma (“MCL”). Trodelvy® (sacituzumab govitecan-hziy) sales increased 53% to $299 million in the fourth quarter 2023 compared to the same period in 2022, reflecting higher demand in both the United States and Europe. Veklury sales decreased 28% to $720 million in the fourth quarter 2023 compared to the same period in 2022, primarily driven by lower rates of COVID-19 related hospitalizations. Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccinations and alternative treatments for COVID-19. Fourth Quarter 2023 Product Gross Margin, Operating Expenses and Tax Product gross margin was 70.4% in the fourth quarter 2023 compared to 81.0% in the same period in 2022, primarily driven by restructuring expenses related to changes in our manufacturing strategy, intangible asset amortization expenses related to Trodelvy following approval for pretreated HR+/HER2- metastatic breast cancer in February 2023, and product mix. Non-GAAP product gross margin was 86.1% in the fourth quarter 2023 compared to 86.8% in the same period in 2022, primarily driven by product mix. Research and development (“R&D”) expenses were $1.4 billion in the fourth quarter 2023 compared to $1.5 billion in the same period in 2022, driven by the timing of clinical activities and valuation adjustments to the MYR-related contingent consideration, partially offset by increased investments in Oncology. Non-GAAP R&D expenses were $1.5 billion in the fourth quarter 2023 and in the same period in 2022. Decreases due to the timing of clinical activities were offset by increased investments in Oncology. Acquired in-process research and development (“IPR&D”) expenses were $347 million in the fourth quarter 2023, primarily driven by payments related to collaborations with Arcellx, Inc. (“Arcellx”), Assembly Biosciences, Inc. (“Assembly”), and Compugen Ltd. (“Compugen”), as well as a milestone payment related to the acquisition of XinThera, Inc. (“XinThera”). Selling, general and administrative (“SG&A”) and non-GAAP SG&A expenses were $1.6 billion in the fourth quarter 2023 compared to $2.0 billion in the same period in 2022. The decrease was primarily driven by a 2022 charge related to the termination of the Trodelvy collaboration agreement with Everest Medicines (“Everest”) that did not repeat. The effective tax rate (“ETR”) was 14.3% in the fourth quarter 2023 compared to 19.6% in the same period in 2022, primarily due to remeasurement of certain deferred tax liabilities and non-taxable unrealized gains on equity investments. Non-GAAP ETR was 17.1% in the fourth quarter 2023 compared to 16.8% in the same period in 2022. Full Year 2023 Financial Results Total full year 2023 revenue decreased 1% to $27.1 billion compared to 2022, driven by a reduction of $1.7 billion in Veklury sales, largely offset by higher HIV and Oncology sales. Diluted EPS increased to $4.50 in the full year 2023 compared to $3.64 in 2022, primarily due to lower IPR&D impairment expenses, lower unrealized losses on equity investments, and higher interest income, partially offset by higher cost of goods sold and operating expenses, and lower Veklury sales. Non-GAAP diluted EPS decreased to $6.72 in the full year 2023 compared to $7.26 in 2022. This was primarily driven by higher total costs and expenses, as well as lower Veklury sales, partially offset by a decrease in tax reserves as a result of reaching an agreement with a tax authority, and higher interest income. Full Year 2023 Product Sales Total full year 2023 product sales of $26.9 billion were relatively flat compared to the same period in 2022, with lower Veklury sales largely offset by higher HIV and Oncology sales. Total product sales, excluding Veklury, increased 7% to $24.7 billion in the full year 2023 compared to 2022, primarily driven by higher HIV and Oncology sales. HIV product sales increased 6% to $18.2 billion in the full year 2023 compared to 2022, primarily reflecting higher demand across treatment and prevention, in addition to higher average realized price and favorable channel inventory dynamics. Biktarvy sales increased 14% to $11.8 billion in the full year 2023 compared to 2022, primarily reflecting higher demand as well as higher average realized price. Descovy sales increased 6% to $2.0 billion in the full year 2023 compared to 2022, primarily driven by favorable channel inventory dynamics and higher demand. The Liver Disease portfolio sales decreased 1% to $2.8 billion in the full year 2023 compared to 2022. The decrease was primarily driven by unfavorable HCV pricing dynamics and foreign exchange rates, partially offset by higher demand across HCV, HDV and chronic hepatitis B virus (“HBV”) products. Cell Therapy product sales increased 28% to $1.9 billion in the full year 2023 compared to 2022. Yescarta sales increased 29% to $1.5 billion in the full year 2023 compared to 2022, primarily driven by increased demand in R/R LBCL. Tecartus sales increased 24% to $370 million in the full year 2023 compared to 2022, primarily driven by increased demand in in R/R ALL and R/R MCL. Trodelvy sales increased 56% to $1.1 billion in the full year 2023 compared to 2022, reflecting strong demand in new and existing geographies. Veklury sales decreased 44% to $2.2 billion in the full year 2023 compared to 2022, primarily driven by lower rates of COVID-19 related hospitalizations in all regions. Full Year 2023 Product Gross Margin, Operating Expenses and Tax Product gross margin was 75.9% in the full year 2023 compared to 79.0% in 2022, primarily driven by restructuring expenses related to the aforementioned changes in our manufacturing strategy, increased amortization expenses, and product mix. Non-GAAP product gross margin was 86.3% in the full year 2023 compared to 86.6% in 2022, primarily driven by product mix. R&D and non-GAAP R&D expenses were $5.7 billion in the full year 2023 compared to $5.0 billion in 2022. This primarily reflects increased clinical activities across our Oncology and Virology programs. Acquired IPR&D expenses were $1.2 billion in the full year 2023, primarily driven by payments related to the collaboration with Arcellx, as well as the acquisition of XinThera and Tmunity Therapeutics Inc. (“Tmunity”). SG&A expenses were $6.1 billion in the full year 2023 compared to $5.7 billion in 2022. Non-GAAP SG&A expenses were $6.1 billion in the full year 2023 compared to $5.6 billion in 2022. The increases in SG&A and non-GAAP SG&A expenses are primarily due to a $525 million litigation settlement with certain plaintiffs in the HIV antitrust litigation and increased commercial activities in Oncology and HIV, partially offset by the 2022 charge related to the termination of the Trodelvy collaboration agreement with Everest. The ETR and non-GAAP ETR were 18.2% and 15.2%, respectively, in the full year 2023 compared to 21.5% and 19.3%, respectively, in 2022. Lower ETR is primarily due to a decrease in tax reserves as a result of reaching agreement with a tax authority on certain tax positions. Guidance and Outlook Gilead is providing full-year 2024 guidance below: Total product sales between $27.1 billion and $27.5 billion. Total product sales, excluding Veklury, between $25.8 billion and $26.2 billion. Total Veklury sales of approximately $1.3 billion. Diluted EPS between $5.15 and $5.55. Non-GAAP diluted EPS between $6.85 and $7.25. 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 Announced that the Phase 3 OAKTREE trial of obeldesivir in non-hospitalized participants without risk factors for developing severe COVID-19 did not meet its primary endpoint of improvement in time to symptom alleviation. Obeldesivir was well-tolerated in this large study population. Oncology Announced that the Phase 3 EVOKE-01 study of Trodelvy versus docetaxel in previously treated metastatic non-small cell lung cancer did not meet its primary endpoint of overall survival. While not statistically powered, we observed an encouraging trend in a subgroup of patients non-responsive to prior anti-PD-(L)1 immunotherapy, that we may potentially explore further. Presented new data at the San Antonio Breast Cancer Symposium 2023, including a post-hoc, subgroup analysis of clinical outcomes by age from the Phase 3 TROPiCS-02 study of Trodelvy in HR+/HER2- metastatic breast cancer. Presented new data at the American Society of Hematology 2023 Annual Meeting (“ASH”) including long-term follow-up across Yescarta trials in R/R LBCL, first-line high-risk LBCL, and R/R follicular lymphoma, as well as real-world data for Tecartus in R/R MCL and B-cell ALL. Received U.S. Food and Drug Administration (“FDA”) approval of Yescarta’s label update to include overall survival (“OS”) data from the Phase 3 ZUMA-7 study, which showed a statistically significant OS improvement for Yescarta in second-line R/R LBCL versus standard of care. Received FDA approval of a manufacturing process change resulting in reduced median turnaround time for Yescarta in the U.S. to an anticipated 14 days (from 16 days previously). Our partner Arcellx presented updated data at ASH from the Phase 1 trial evaluating anitocabtagene autoleucel (“anito-cel”) in R/R multiple myeloma. With 26.5 months of median follow-up, the data demonstrated continued deep and durable responses, including in patients with extramedullary disease, with median progression-free survival not reached. In addition, no cases of delayed neurotoxicity events or parkinsonian symptoms were observed. Announced expansion of the Arcellx collaboration to include exercising an option for the ARC-SparX ACLX-001 program in multiple myeloma, expanding the scope of the existing anito-cel collaboration to include lymphomas, and a further equity investment of $200 million. Announced an amended collaboration agreement with Arcus Biosciences, Inc. (“Arcus”), including an update to the domvanalimab development collaboration program, and an additional $320 million equity investment. Announced an exclusive license agreement with Compugen for later-stage development and commercialization of novel pre-clinical anti-IL18 binding protein antibodies, including COM503, that have the potential to treat various tumor types. Corporate Announced that Ted Love has joined Gilead’s Board of Directors. Named to Dow Jones Sustainability World Index for third consecutive year and added to the North America Index for the first year, reflecting Gilead’s ongoing commitment to corporate responsibility and sustainability. The company’s Board of Directors declared a quarterly dividend of $0.77 per share of common stock for the first quarter of 2024. The dividend is payable on March 28, 2024, to stockholders of record at the close of business on March 15, 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 2:00 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on and will be archived on for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges, 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 strategic 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, Arcus, Assembly, Compugen, Galapagos NV, MYR, Tmunity, and XinThera; 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 Tecartus, Trodelvy (including EVOKE-01), Yescarta, anito-cel and domvanalimab, 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 regulatory approvals in a timely manner or at all, and the risk that any such approvals, if granted, may be subject to significant limitations on use; 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 these products over other therapies and may therefore be reluctant to prescribe the products, including Yescarta; 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 December 31, 2023 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™, 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 or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except per share amounts) 2023 2022 2023 2022 Revenues: Product sales $ 7,070 $ 7,333 $ 26,934 $ 26,982 Royalty, contract and other revenues 45 56 182 299 Total revenues 7,115 7,389 27,116 27,281 Costs and expenses: Cost of goods sold 2,090 1,396 6,498 5,657 Research and development expenses 1,408 1,548 5,718 4,977 Acquired in-process research and development expenses 347 158 1,155 944 In-process research and development impairment 50 — 50 2,700 Selling, general and administrative expenses 1,608 2,020 6,090 5,673 Total costs and expenses 5,503 5,122 19,511 19,951 Operating income 1,612 2,267 7,605 7,330 Interest expense (252 ) (227 ) (944 ) (935 ) Other income (expense), net 293 (9 ) 198 (581 ) Income before income taxes 1,653 2,031 6,859 5,814 Income tax expense (236 ) (398 ) (1,247 ) (1,248 ) Net income 1,417 1,633 5,613 4,566 Net loss attributable to noncontrolling interest 12 7 52 26 Net income attributable to Gilead $ 1,429 $ 1,640 $ 5,665 $ 4,592 Basic earnings per share attributable to Gilead $ 1.15 $ 1.31 $ 4.54 $ 3.66 Shares used in basic earnings per share attributable to Gilead calculation 1,248 1,252 1,248 1,255 Diluted earnings per share attributable to Gilead $ 1.14 $ 1.30 $ 4.50 $ 3.64 Shares used in diluted earnings per share attributable to Gilead calculation 1,256 1,264 1,258 1,262 Cash dividends declared per share $ 0.75 $ 0.73 $ 3.00 $ 2.92 Research and development expenses as a % of revenues 19.8 % 20.9 % 21.1 % 18.2 % Selling, general and administrative expenses as a % of revenues 22.6 % 27.3 % 22.5 % 20.8 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2023 2022 Change 2023 2022 Change Product sales: HIV $ 4,693 $ 4,772 (2 )% $ 18,175 $ 17,194 6 % Oncology 765 614 24 % 2,932 2,139 37 % Liver Disease 691 694 — % 2,784 2,798 (1 )% Other 201 252 (20 )% 859 946 (9 )% Total product sales excluding Veklury 6,350 6,333 — % 24,750 23,077 7 % Veklury 720 1,000 (28 )% 2,184 3,905 (44 )% Total product sales 7,070 7,333 (4 )% 26,934 26,982 — % Royalty, contract and other revenues 45 56 (21 )% 182 299 (39 )% Total revenues $ 7,115 $ 7,389 (4 )% $ 27,116 $ 27,281 (1 )% GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2023 2022 Change 2023 2022 Change Non-GAAP: Cost of goods sold $ 980 $ 968 1 % $ 3,697 $ 3,602 3 % Research and development expenses $ 1,452 $ 1,544 (6 )% $ 5,720 $ 4,968 15 % Acquired IPR&D expenses(2) $ 347 $ 158 NM $ 1,155 $ 944 22 % Selling, general and administrative expenses $ 1,597 $ 2,020 (21 )% $ 6,060 $ 5,587 8 % Other income (expense), net $ 104 $ 52 NM $ 365 $ 77 NM Diluted EPS $ 1.72 $ 1.67 3 % $ 6.72 $ 7.26 (7 )% Product gross margin 86.1 % 86.8 % -66 bps 86.3 % 86.6 % -38 bps Research and development expenses as a % of revenues 20.4 % 20.9 % -49 bps 21.1 % 18.2 % 288 bps Selling, general and administrative expenses as a % of revenues 22.4 % 27.3 % -490 bps 22.3 % 20.5 % 187 bps Operating margin 38.5 % 36.5 % 197 bps 38.7 % 44.6 % -598 bps Effective tax rate 17.1 % 16.8 % 22 bps 15.2 % 19.3 % -416 bps ________________________________ 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 Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2023 2022 2023 2022 Cost of goods sold reconciliation: GAAP cost of goods sold $ 2,090 $ 1,396 $ 6,498 $ 5,657 Acquisition-related – amortization(1) (580 ) (428 ) (2,271 ) (2,013 ) Restructuring . (479 ) — (479 ) (42 ) Other(2) (51 ) — (51 ) — Non-GAAP cost of goods sold $ 980 $ 968 $ 3,697 $ 3,602 Product gross margin reconciliation: GAAP product gross margin 70.4 % 81.0 % 75.9 % 79.0 % Acquisition-related – amortization(1) 8.2 % 5.8 % 8.4 % 7.5 % Restructuring . 6.8 % — % 1.8 % 0.2 % Other(2) 0.7 % — % 0.2 % — % Non-GAAP product gross margin 86.1 % 86.8 % 86.3 % 86.6 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,408 $ 1,548 $ 5,718 $ 4,977 Acquisition-related – other costs(4) 59 (1 ) 22 13 Restructuring . (15 ) . (4 ) (20 ) (22 ) Non-GAAP research and development expenses $ 1,452 $ 1,544 $ 5,720 $ 4,968 IPR&D impairment reconciliation: GAAP IPR&D impairment $ 50 $ — $ 50 $ 2,700 IPR&D impairment (50 ) — (50 ) (2,700 ) Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,608 $ 2,020 $ 6,090 $ 5,673 Acquisition-related – other costs(4) — (1 ) (2 ) (3 ) Restructuring (11 ) . 1 (28 ) 2 Other(3) — — — (85 ) Non-GAAP selling, general and administrative expenses $ 1,597 $ 2,020 $ 6,060 $ 5,587 Operating income reconciliation: GAAP operating income $ 1,612 $ 2,267 $ 7,605 $ 7,330 Acquisition-related – amortization(1) 580 428 2,271 2,013 Acquisition-related – other costs(4) (59 ) . 2 (20 ) (10 ) Restructuring 505 . 2 527 62 IPR&D impairment 50 . — 50 2,700 Other(2)(3) 51 — 51 85 Non-GAAP operating income $ 2,739 $ 2,699 $ 10,484 $ 12,180 Operating margin reconciliation: GAAP operating margin 22.7 % 30.7 % 28.0 % 26.9 % Acquisition-related – amortization(1) 8.1 % 5.8 % 8.4 % 7.4 % Acquisition-related – other costs(4) (0.8 ) % — % (0.1 ) % — % Restructuring . 7.1 % — % 1.9 % 0.2 % IPR&D impairment 0.7 % — % 0.2 % 9.9 % Other(2)(3) 0.7 % — % 0.2 % 0.3 % Non-GAAP operating margin 38.5 % 36.5 % 38.7 % 44.6 % Other income (expense), net reconciliation: GAAP other income (expense), net $ 293 $ (9 ) $ 198 $ (581 ) (Gain) loss from equity securities, net (189 ) 61 167 657 Non-GAAP other income (expense), net $ 104 $ 52 $ 365 $ 77 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2023 2022 2023 2022 Effective tax rate reconciliation: GAAP effective tax rate 14.3 % 19.6 % 18.2 % 21.5 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(5) 2.8 % (2.8 ) % (3.0 ) % (2.1 ) % Non-GAAP effective tax rate 17.1 % 16.8 % 15.2 % 19.3 % Net income attributable to Gilead reconciliation: GAAP net income attributable to Gilead $ 1,429 $ 1,640 $ 5,665 $ 4,592 Acquisition-related – amortization(1) 460 346 1,805 1,610 Acquisition-related – other costs(4) (59 ) 1 (29 ) (12 ) Restructuring 414 . 2 431 47 IPR&D impairment 35 — 35 2,057 (Gain) loss from equity securities, net (171 ) 60 180 630 Discrete and related tax charges(5) 12 57 326 175 Other(2)(3) 40 — 40 59 Non-GAAP net income attributable to Gilead $ 2,161 $ 2,106 $ 8,454 $ 9,158 Diluted earnings per share reconciliation: GAAP diluted earnings per share $ 1.14 $ 1.30 $ 4.50 $ 3.64 Acquisition-related – amortization(1) 0.37 0.27 1.43 1.28 Acquisition-related – other costs(4) (0.05 ) — (0.02 ) (0.01 ) Restructuring . 0.33 — 0.34 0.04 IPR&D impairment 0.03 — 0.03 1.63 (Gain) loss from equity securities, net (0.14 ) 0.05 0.14 0.50 Discrete and related tax charges(5) 0.01 0.05 0.26 0.14 Other(2)(3) 0.03 — 0.03 0.05 Non-GAAP diluted earnings per share $ 1.72 $ 1.67 $ 6.72 $ 7.26 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 1,110 $ 428 $ 2,801 $ 2,055 Research and development expenses adjustments (44 ) 4 (2 ) 9 IPR&D impairment adjustments 50 — 50 2,700 Selling, general and administrative expenses adjustments 11 — 30 86 Total non-GAAP adjustments to costs and expenses 1,127 432 2,879 4,850 Other income (expense), net, adjustments (189 ) 61 167 657 Total non-GAAP adjustments before income taxes 938 493 3,046 5,507 Income tax effect of non-GAAP adjustments above (218 ) (84 ) (583 ) (1,116 ) Discrete and related tax charges(5) 12 57 326 175 Total non-GAAP adjustments to net income attributable to Gilead $ 732 $ 466 $ 2,789 $ 4,566 ______________________________ (1) Relates to amortization of acquired intangibles and inventory step-up charges. (2) Relates to a write-off of an intangible asset related to the restructuring of our collaboration with Galapagos NV during the fourth quarter of 2023. (3) Relates to donations to the Gilead Foundation, a California nonprofit organization, during the second quarter of 2022. (4) 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. and XinThera, Inc. (5) 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 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 76.0% - 77.0% Acquisition-related expenses and other ~ 9.0% Non-GAAP projected product gross margin 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $8,700 - $9,200 Acquisition-related expenses and other ~ 2,500 Non-GAAP projected operating income $11,200 - $11,700 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 21% Income tax effect of above non-GAAP adjustments, and discrete and related tax adjustments (~ 2%) Non-GAAP projected effective tax rate ~ 19% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.15 - $5.55 Acquisition-related expenses and other, and discrete and related tax adjustments ~ 1.70 Non-GAAP projected diluted EPS $6.85 - $7.25 ________________________________ (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) December 31, (in millions) 2023 2022 Assets Cash, cash equivalents and marketable debt securities $ 8,428 $ 7,630 Accounts receivable, net 4,660 4,777 Inventories 3,366 2,820 Property, plant and equipment, net 5,317 5,475 Intangible assets, net 26,454 28,894 Goodwill 8,314 8,314 Other assets 5,586 5,262 Total assets $ 62,125 $ 63,171 Liabilities and Stockholders’ Equity Current liabilities $ 11,280 $ 11,237 Long-term liabilities 28,096 30,725 Stockholders’ equity(1) 22,749 21,209 Total liabilities and stockholders’ equity $ 62,125 $ 63,171 ________________________________ (1) As of December 31, 2023 and 2022, there were 1,246 and 1,247 shares of common stock issued and outstanding, respectively. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 Net cash provided by operating activities $ 2,168 $ 2,566 $ 8,006 $ 9,072 Net cash used in investing activities (726 ) (374 ) (2,265 ) (2,466 ) Net cash used in financing activities (1,100 ) (1,554 ) (5,125 ) (6,469 ) Effect of exchange rate changes on cash and cash equivalents 37 75 57 (63 ) Net change in cash and cash equivalents 380 713 673 74 Cash and cash equivalents at beginning of period 5,705 4,699 5,412 5,338 Cash and cash equivalents at end of period $ 6,085 $ 5,412 $ 6,085 $ 5,412 Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 Net cash provided by operating activities $ 2,168 $ 2,566 $ 8,006 $ 9,072 Capital expenditures (214 ) (181 ) (585 ) (728 ) Free cash flow(1) $ 1,954 $ 2,386 $ 7,421 $ 8,344 ________________________________ (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 Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 HIV Biktarvy – U.S. $ 2,588 $ 2,423 $ 9,692 $ 8,510 Biktarvy – Europe 333 295 1,253 1,103 Biktarvy – Other International 188 200 905 777 3,109 2,918 11,850 10,390 Complera / Eviplera – U.S. 6 17 47 74 Complera / Eviplera – Europe 15 37 70 113 Complera / Eviplera – Other International 3 3 12 13 24 58 129 200 Descovy – U.S. 457 479 1,771 1,631 Descovy – Europe 25 26 100 118 Descovy – Other International 28 31 114 123 509 537 1,985 1,872 Genvoya – U.S. 447 543 1,752 1,983 Genvoya – Europe 48 64 205 284 Genvoya – Other International 22 33 103 136 517 640 2,060 2,404 Odefsey – U.S. 258 295 1,012 1,058 Odefsey – Europe 71 85 294 364 Odefsey – Other International 11 11 44 47 340 392 1,350 1,469 Stribild – U.S. 15 20 72 88 Stribild – Europe 5 7 21 29 Stribild – Other International 2 3 8 10 22 29 101 127 Truvada – U.S. 12 37 82 113 Truvada – Europe 3 3 13 15 Truvada – Other International 3 5 19 18 18 45 114 147 Revenue share – Symtuza(1) – U.S. 104 97 382 348 Revenue share – Symtuza(1) – Europe 32 42 133 168 Revenue share – Symtuza(1) – Other International 3 3 13 14 139 142 529 530 Other HIV(2) – U.S. 13 4 37 15 Other HIV(2) – Europe 1 5 12 24 Other HIV(2) – Other International 1 3 7 17 15 12 56 57 Total HIV – U.S. 3,899 3,914 14,848 13,820 Total HIV – Europe 533 566 2,102 2,219 Total HIV – Other International 261 293 1,226 1,155 $ 4,693 $ 4,772 $ 18,175 $ 17,194 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 Oncology Cell Therapy Tecartus – U.S. $ 66 $ 61 $ 245 $ 221 Tecartus – Europe 27 19 110 75 Tecartus – Other International 5 1 15 3 98 82 370 299 Yescarta – U.S. 187 219 811 747 Yescarta – Europe 140 103 547 355 Yescarta – Other International 42 15 140 57 368 337 1,498 1,160 Total Cell Therapy – U.S. 253 281 1,055 968 Total Cell Therapy – Europe 167 122 658 430 Total Cell Therapy – Other International 46 17 156 60 466 419 1,869 1,459 Trodelvy Trodelvy – U.S. 226 146 777 525 Trodelvy– Europe 48 44 217 143 Trodelvy – Other International 24 4 68 12 299 195 1,063 680 Total Oncology – U.S. 479 427 1,833 1,494 Total Oncology – Europe 216 166 875 573 Total Oncology – Other International 70 21 224 73 765 614 2,932 2,139 Liver Disease HCV Ledipasvir / Sofosbuvir(3) – U.S. 11 19 39 46 Ledipasvir / Sofosbuvir(3) – Europe 1 4 12 17 Ledipasvir / Sofosbuvir(3) – Other International 5 8 19 51 17 31 70 115 Sofosbuvir / Velpatasvir(4) – U.S. 216 214 859 844 Sofosbuvir / Velpatasvir(4) – Europe 74 67 323 355 Sofosbuvir / Velpatasvir(4) – Other International 89 87 355 331 378 369 1,537 1,530 Other HCV(5) – U.S. 25 27 104 115 Other HCV(5) – Europe 10 9 43 40 Other HCV(5) – Other International 3 3 12 10 37 39 160 166 Total HCV – U.S. 251 260 1,002 1,005 Total HCV – Europe 84 80 378 413 Total HCV – Other International 97 98 386 392 $ 432 $ 439 $ 1,767 $ 1,810 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 HBV/HDV Vemlidy – U.S. $ 115 $ 123 $ 410 $ 429 Vemlidy – Europe 10 8 38 35 Vemlidy – Other International 92 89 414 379 217 220 862 842 Viread – U.S. 4 2 8 6 Viread – Europe 6 6 22 23 Viread – Other International 12 14 52 62 21 22 83 91 Other HBV/HDV(6) – U.S. — (1 ) — — Other HBV/HDV(6) – Europe 22 14 72 55 22 13 72 55 Total HBV/HDV – U.S. 119 124 418 435 Total HBV/HDV – Europe 37 28 133 112 Total HBV/HDV – Other International 103 103 466 441 259 255 1,017 988 Total Liver Disease – U.S. 370 384 1,421 1,440 Total Liver Disease – Europe 121 108 511 525 Total Liver Disease – Other International 200 202 852 833 691 694 2,784 2,798 Veklury Veklury – U.S. 364 395 972 1,575 Veklury – Europe 181 142 408 702 Veklury – Other International 175 462 805 1,628 720 1,000 2,184 3,905 Other AmBisome – U.S. 4 9 43 57 AmBisome – Europe 68 66 260 258 AmBisome – Other International 39 42 189 182 111 117 492 497 Letairis – U.S. 36 60 142 196 Other(7) – U.S. 28 44 118 135 Other(7) – Europe 9 13 40 65 Other(7) – Other International 17 18 66 53 54 75 225 253 Total Other – U.S. 68 113 304 388 Total Other – Europe 77 79 301 323 Total Other – Other International 56 61 255 235 201 252 859 946 Total product sales – U.S. 5,180 5,234 19,377 18,716 Total product sales – Europe 1,128 1,061 4,197 4,342 Total product sales – Other International 762 1,037 3,361 3,924 $ 7,070 $ 7,333 $ 26,934 $ 26,982 _______________________________ (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, Emtriva, Sunlenca and Tybost. (3) Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC. (4) Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC. (5) Includes Vosevi and Sovaldi. (6) Includes Hepcludex and Hepsera. (7) Includes Cayston, Jyseleca, Ranexa and Zydelig.

Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months GC012F is a FasTCAR-enabled B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T therapy being evaluated for hematologic malignancies and autoimmune disease Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented updated results from the clinical investigator-initiated trial (IIT) of GC012F for treatment of newly diagnosed multiple myeloma (NDMM) as an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place in San Diego, California and online. GC012F demonstrated a 100% overall response rate (ORR) and 95% MRD- sCR rate among 22 transplant-eligible, high-risk NDMM patients as of the data cutoff date of October 1, 2023. The data included longer-term follow-up from the initial 16 patients, for whom earlier results were presented at the 2022 American Society for Hematology (ASH) Annual Meeting, plus six additional patients that were enrolled and treated later. The data also showed that GC012F was well-tolerated with no new safety signals observed in this frontline application of CAR-T therapy. “We are delighted to announce the updated data of FasTCAR-T GC012F for the treatment of multiple myeloma patients in the frontline setting. The clinical data continue to highlight the depth of response and highly favorable safety profile delivered by GC012F, as well as the greatly shortened manufacturing turnaround time, demonstrating the compelling benefits of our innovative dual-targeting approach and the FasTCAR next-day manufacturing technology,” said Dr. Wendy Li, Gracell’s Chief Medical Officer. “This dataset further strengthens the growing clinical evidence supporting the considerable potential of FasTCAR-T GC012F and underscores our dedication to pioneering breakthroughs in cell therapy.” In the ongoing single-arm, open label, Phase 1 IIT, patients with NDMM were enrolled and treated with GC012F at three dose levels. All patients had one or more high-risk features, of which 91% (20/22) were classified as Stage II or III based on the Revised International Staging System (R-ISS), and 55% (12/22) had extramedullary plasmacytoma. As of the data cutoff date of October 1, 2023 and with a median follow-up of 18.8 months (range: 6.6-28.4 months), the 22 evaluable patients achieved strong response rates following GC012F infusion: 100% (22/22) ORR; 95% (21/22) sCR; 100% (22/22) MRD-, as assessed by Euroflow at a sensitivity of 10-6; Median duration of response (DOR) and median progression free survival (PFS) were not reached at the data cutoff date. GC012F continued to show a favorable safety profile in the longer-term follow-up with no new safety findings: Only 27% (6/22) patients experienced cytokine release syndrome (CRS), all of which were low-grade, either Grade 1 (23%, 5/22) or Grade 2 (5%, 1/22) and resolved within four days; No CRS of any grade occurred in the remaining 73% (16/22) of patients; No immune effector cell-associated toxicity (ICANS) or neurotoxicity of any grade occurred. Additional information about the presentation and the ASH Annual Meeting is available on the ASH website. GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with an improved safety profile. GC012F is currently being evaluated in clinical studies in multiple hematological cancers as well as autoimmune diseases and has demonstrated a consistently strong efficacy and safety profile. Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the treatment of relapsed or refractory multiple myeloma in the United States and a Phase 1/2 clinical trial in China is to be commenced imminently. An IIT has also been launched to evaluate GC012F for the treatment of refractory systemic lupus erythematosus (rSLE) and Investigational New Drug application to study GC012F in rSLE has been cleared by the U.S. FDA. Introduced in 2017, FasTCAR is Gracell’s revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to lead the next generation of therapy for cancer and autoimmune diseases, and improve outcomes for patients by enhancing effect, reducing costs, and enabling more patients to access critical CAR-T treatment. FasTCAR drastically shortens cell production from weeks to overnight, potentially reducing patient wait times and probability for their disease to progress. Furthermore, FasTCAR T-cells appear younger than traditional CAR-T cells, making them more proliferative and effective at killing cancer cells. In 2022 and 2023, FasTCAR was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards and the Overall Immunology Solution of 2023 by BioTech Breakthrough Awards, for its ability to address major industry obstacles. Gracell Biotechnologies Inc. (“Gracell”) is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies for the treatment of cancers and autoimmune diseases. Leveraging its innovative FasTCAR and TruUCAR technology platforms and SMART CART™ technology module, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost, and lack of effective CAR-T therapies for solid tumors and autoimmune diseases. The lead candidate BCMA/CD19 dual-targeting FasTCAR-T GC012F is currently being evaluated in clinical studies for the treatment of multiple myeloma, B-NHL and SLE. For more information on Gracell, please visit www.gracellbio.com. Follow @GracellBio on LinkedIn. 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At Almost Four Years of Follow-up in the Pivotal ZUMA-2 Study, Median Overall Survival was 46.4 Months, Supporting Long-Term Response in Adult Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Real-World Evidence (RWE) Shows Effectiveness in Adult R/R MCL with a Complete Response Rate of 81% and 84% for High-Risk Features (Patients with TP53 /17p Deletion) RWE Also Shows a Complete Remission/CRi Rate of 76% in Adult Patients with R/R B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL) SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced the results of four new analyses supporting the use of Tecartus® (brexucabtagene autoleucel) in relapsed/refractory mantle cell lymphoma (R/R MCL) and relapsed/refractory adult B-cell precursor acute lymphoblastic leukemia (R/R B-ALL). These results include four-year overall survival (OS) data from the pivotal ZUMA-2 study and primary results from ZUMA-18, an expanded access study, evaluating the CAR T-cell therapy Tecartus in patients with R/R MCL that were presented orally (Abstract #106) at the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition. An analysis from ZUMA-2 showing that patients who received early versus late intervention for management of cytokine release syndrome (CRS) and neurological events experienced improved safety outcomes was also presented in a poster session (Abstract #2120). In addition, real-world findings on effectiveness and safety outcomes from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational database of U.S. patients who received Tecartus for R/R MCL (Abstract #107) were highlighted in an oral session; CIBMTR data from adult patients with R/R B-ALL (Abstract #1029) were also presented orally today. “The clinical results and real-world evidence presented at ASH clearly support the potential for long-term response and safety of Tecartus in aggressive blood cancers for which patients have limited treatment options,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. “We are particularly encouraged that the real-world evidence demonstrates consistent outcomes for Tecartus among a broader range of patients.” Detailed Information on Tecartus Abstracts: (Abstract #106) Outcomes of Patients with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Treated with Brexucabtagene Autoleucel (Brexu-cel) in ZUMA-2 and ZUMA-18, an Expanded Access Study At a median follow-up of 47.5 months in all 68 patients with R/R MCL who had previously received anthracycline or bendamustine-containing chemotherapy; an anti CD20 antibody; and a Bruton’s tyrosine kinase inhibitor (BTKi; ibrutinib or acalabrutinib); and were treated with Tecartus in the pivotal ZUMA-2 study, median OS was 46.4 months with 30 patients (44%) still alive at data cutoff. The median OS for patients with complete response (CR) (n=46) was 58.7 months. Efficacy and safety outcomes for 23 patients with R/R MCL enrolled in ZUMA-18, a multicenter, open-label, expanded-access study of Tecartus, were also presented. With a median follow-up of 33.5 months, the investigator-assessed objective response rate (ORR) was 87% (95% Confidence Interval [CI], 66.4-97.2); 57% had a CR (95% CI, 34.5-76.8), 30% had a partial response (95% CI, 13.2-52.9), and 9% had progressive disease (95% CI, 1.1-28.0) as their best response to Tecartus. The median OS was not reached (95% CI, 10.4-not estimable) at data cutoff with a 58% OS rate at 24 months. At data cutoff, 61% of patients were still alive. All 23 patients who received Tecartus in ZUMA-18 experienced at least one Grade ≥3 adverse event (AE); Grade ≥3 CRS and neurological events occurred in one patient (4%) and eight patients (35%), respectively. Five Grade 5 AEs occurred, one that was deemed related to Tecartus therapy (multiple organ dysfunction syndrome on Day 20) and four that were deemed unrelated to Tecartus therapy (sepsis [2, Days 123 and 219], aspiration [1, on Day 49], and encephalopathy [1, on Day 68]). “Consistent with ZUMA-2 findings, which showed a median overall survival of 46.4 months in patients with a complete response, brexu-cel demonstrated a high level of efficacy in relapsed/refractory mantle cell lymphoma patients in the ZUMA-18 expanded-access study, with less serious cytokine release syndrome,” said Andre Goy, MD, ZUMA-2 investigator and Lymphoma Division Chief, John Theurer Cancer Center, Hackensack University Medical Center. “Together, the results of these two studies provide strong support for the continued use of brexu-cel in the relapsed/refractory mantle cell lymphoma setting.” (Abstract #107) Real-world Outcomes of Brexucabtagene Autoleucel (Brexu-cel) for Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL): A CIBMTR Subgroup Analysis of High-Risk Characteristics Patients with R/R MCL and TP53 mutation/deletion or high Ki-67 proliferation index (PI) have historically had limited treatment options with dismal outcomes. In a previously presented three-year follow-up of ZUMA-2, outcomes were comparable across various high-risk subgroups, including in patients with TP53 mutation or Ki-67 PI ≥ 30% or ≥ 50%. An analysis of a CIBMTR observational database of R/R MCL patients receiving Tecartus from 84 U.S. centers was presented. With a median follow-up of 12.2 months, CR rates were high among these challenging-to-treat sub-populations: For patients with deletion of TP53/17p (n=44), CR was 84% compared to 81% in those without (n=183) For patients with Ki-67 PI ≥ 50% (n=146), CR was 83% vs 84% in those with Ki-67 PI < 50% (n=111). Safety endpoints were largely consistent among all subgroups. Prolonged neutropenia and thrombocytopenia occurred more frequently in patients with vs without deletion of TP53/17p (25% vs 13% and 28% vs 16%, respectively). Grade ≥ 3 CRS occurred more frequently in ZUMA-2-ineligible vs eligible patients (13% vs 7%). After multivariable adjustment, all effectiveness and most safety outcomes were consistent regardless of deletion of TP53/17p and Ki-67 >+50%. “These real-world findings suggest that outcomes of brexu-cel treatment, including a high complete response rate, are largely consistent, regardless of ZUMA-2 eligibility or the high-risk feature subgroups analyzed. Although patients without deletion of TP53/17p appeared to have longer overall survival than patients with, the data further demonstrate the safety and durability of response of brexu-cel for patients with relapsed/refractory mantle cell lymphoma, who typically face poor prognoses and have limited treatment options,” said Swetha Kambhampati, MD, lead investigator, City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. (Abstract #1029) Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for relapsed or refractory (R/R) adult B-cell acute lymphoblastic leukemia (B-cell ALL): Evidence from the CIBMTR registry This real-world evidence study of Tecartus in adult patients with B-ALL examined a CIBMTR registry database of 150 patients across 67 centers in the United States. The assessment found the overall complete remission or complete remission with incomplete hematological recovery (CR/CRi) rate by Day 100 post-infusion was 76%, and 70% were still in remission at 6 months post-initial response (95% CI: 55-80). For those who were not in response prior to lymphodepletion (LD), 63% of these patients converted to a CR/CRi post-infusion. The OS rate at six months was 78% (95% CI: 69-84); primary causes of death were primary disease (n=13/32, 41%) and infection (n=7/32, 22%). About one-third (31%) of responders received a subsequent allogeneic stem cell transplant (allo SCT). High response rates were observed in all patients regardless of age, prior exposure to blinatumomab, prior allo SCT, or the presence of extramedullary disease prior to LD. Grade ≥3 CRS and immune effector cell-associated neurotoxicity syndrome (ICANS, ASTCT consensus) occurred in 9% and 24% of patients, respectively. Treatment for CRS and/or ICANS consisted mainly of tocilizumab (67%) and corticosteroids (51%). Most of these AEs were resolved within three weeks of infusion (CRS, 94%; ICANS, 80%). Prolonged cytopenia and neutropenia 30 days post-infusion were experienced by 42% and 33% of patients, respectively. “It is encouraging to see that the efficacy and safety outcomes of the largest real-world evidence study of brexu-cel in B-ALL are consistent with the results of the ZUMA-3 study, with high response rates in a broad, actual patient population,” said Evandro Bezerra, MD, lead investigator, hematology specialist, Ohio State University Comprehensive Cancer Center. “These findings further build our confidence in the role of brexu-cel in treating adult patients with B-ALL, including those living with high-risk comorbidities and other factors that make treatment particularly challenging.” About ZUMA-2 ZUMA-2 is a single-arm, international multicenter (US and Europe), open-label Phase 2 study involving 74 enrolled/leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BTK inhibitors ibrutinib or acalabrutinib. The objectives of the study are to evaluate the efficacy and safety after a single infusion of KTE-X19 in this patient population. The primary endpoint for the study is objective response rate and is defined as the combined rate of complete responses and partial responses as assessed by an Independent Radiology Review Committee. Secondary endpoints include duration of response, best objective response, progression-free survival, OS, incidence of AEs, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score. The study is ongoing. About ZUMA-18 The U.S. expanded-access ZUMA-18 trial consists of two cohorts of 27 patients per total. The primary objectives were to provide access to Tecartus for patients with R/R MCL until it was commercially available (Cohort 1) and patients with R/R MCL whose manufactured product did not meet commercial release specifications (Cohort 2). In Cohort 1, adults (≥18 years) with R/R MCL with ≥1 prior regimen underwent leukapheresis and conditioning chemotherapy followed by a single infusion of Tecartus at a target dose of 2×106 cells/kg (or fixed dose of 2x108 anti-CD19 CAR T cells for patients who are ≥100 kg). In Cohort 2, patients received Cohort 1 treatment without leukapheresis (initial leukapheresis product used). Key endpoints were safety, ORR, and OS. About Mantle Cell Lymphoma MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. Approximately 33,000 people worldwide are diagnosed with MCL each year. MCL is highly aggressive following relapse, with many patients’ disease progressing following therapy. About Acute Lymphoblastic Leukemia ALL is an aggressive and rare type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs, and is very challenging to treat. In adults, B-ALL is the most common form, accounting for 75% of cases. Survival rates in adults with R/R B-ALL are poor, with a median OS of less than eight months. About Tecartus Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide. Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving Tecartus. Do not administer Tecartus to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic toxicities, including life-threatening reactions, occurred in patients receiving Tecartus, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Tecartus. Provide supportive care and/or corticosteroids as needed. Tecartus 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), including life-threatening reactions, occurred following treatment with Tecartus. CRS occurred in 92% (72/78) of patients with ALL, including ≥ Grade 3 (Lee grading system) CRS in 26% of patients. Three patients with ALL had ongoing CRS events at the time of death. The median time to onset of CRS was five days (range: 1 to 12 days) and the median duration of CRS was eight days (range: 2 to 63 days) for patients with ALL. Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days at the certified healthcare facility, and for four 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 Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 87% (68/78) of patients with ALL, including ≥ Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL. For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus. Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS. The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS. The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus. Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly. REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that: Healthcare facilities that dispense and administer Tecartus must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within two hours after Tecartus infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Tecartus are trained in the management of CRS and neurologic toxicities. Further information is available at or 1-844-454-KITE (5483). Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus. Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of “febrile neutropenia” (11 (14%)) plus the concurrent events of “fever” and “neutropenia” (16 (21%)). 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, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in 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. 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 Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after Tecartus infusion. Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus. Secondary Malignancies may develop. Monitor life-long for secondary malignancies. In the event that one 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 Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period. Adverse Reactions: The most common non-laboratory adverse reactions (≥ 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. The most common serious adverse reactions (≥ 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis. Please see full Prescribing Information, including BOXED WARNING and Medication Guide. About CIBMTR The Center for International Blood and Marrow Transplant Research is a nonprofit research collaboration between the NMDP/Be The Match, in Minneapolis, and the Medical College of Wisconsin, in Milwaukee. CIBMTR collaborates with the global scientific community to increase survival and enrich quality of life for patients. CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, and a unique database of long-term clinical data for more than 635,000 people who have received hematopoietic cell transplantation and other cellular therapies. Learn more at cibmtr.org. 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 supply 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. 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 Tecartus; the possibility that Gilead and Kite may make a strategic decision to discontinue development of programs for indications currently under evaluation and, as a result, such indications may never be successfully commercialized; the risk that physicians may not see the benefits of prescribing Tecartus; 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 September 30, 2023, 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 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, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Kite, please visit the company’s website at or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on X (@KitePharma) and LinkedIn. View source version on businesswire.com: Contacts Jacquie Ross, Investors investor_relations@gilead.com Meaghan Smith, Gilead Media msmith@gilead.com Anna Padula, Kite Media apadula@kitepharma.com Source: Gilead Sciences, Inc. View this news release online at: