Cobicistat /Darunavir/Emtricitabine/Tenofovir Alafenamide Fumarate

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.

▲3月7-8日 成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。昨日，强生公布了2023年业绩，销售额同比增长6.5%，达852亿美元。但净利润仅为133亿美元，同比下降18.6%。但四季度增长较为强劲，销售额实现214亿美元，同比增长7.3%，净利润41亿美元，同比增长28%。美国业务是强生的支柱，全年营收464亿美元，同比增长10.6%，美国以外地区的国际业务全年营收387亿美元，仅同比增长1.9%。因为强生在去年剥离了OTC与保健业务，目前仅剩下创新药和医疗科技（器械和设备）两大业务，其中创新药全年营收548亿美元，同比增长4.2%，器械业务营收304亿美元，同比增长10.8%。在创新药业务中，拉动增长的主要因素是DARZALEX (达雷木单抗)、ERLEADA (阿帕他胺)、TECVAYLI (teclistamab-cqyv) 、CARVYKTI (ciltacabtagene autoleucel)等抗肿瘤产品， STELARA (尤特克单抗)、TREMFYA (古塞奇尤单抗) 等免疫治疗产品，以及新上市的,SPRAVATO (左氯胺酮)。当然，除了增长型产品，阿比特龙、依鲁替尼和英夫利昔单抗等产品，因为专利悬崖而销售额快速下滑。器械业务之所以增长12.4%，一方面是兼并了Abiomed，该公司奉献了4.7%的增长点；另一方面是因为电生理学产品、隐形眼镜、术后伤口缝合产品和生物外科产品异常畅销。强生的创新药业务主要有免疫调节、抗感染、神经系统、肿瘤、肺动脉高压和心血管六大管线。1）免疫领域，全年销售额180.52亿美元，同比增长6.6%。其中英夫利昔单抗全年销售额18.39亿美元，同比下滑21.5%；戈利木单抗销售额21.97亿美元，同比增长0.6%；尤特克单抗销售108.58亿美元，同比增长11.7%；古塞奇尤单抗营收31.47亿美元，同比增长17.9%，其余免疫科产品总销售额仅为1100万美元，同比下降33.8%。2）抗感染领域，全年销售额44.18亿美元，同比下降18.9%。其中新冠疫苗全年营收11.17亿美元，同比下降48.8%；艾滋病药利匹韦林（EDURANT）营收11.5亿美元，同比增长14.1%，鸡尾酒PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA销售额18.54亿美元，同比下降4.6%，其它管线产品总销售额为2.97亿美元，同比下降6.7%。3）CNS领域，全年营收71.4亿美元，同比增长3.6%。其中老药哌甲酯（CONCERTA）销售额7.83亿美元，同比增长21.6%；帕利哌酮纳米晶系列产品（INVEGA SUSTENNA / XEPLION / INVEGA）全年营收41.15亿美元，同比下降0.6%；左氯胺酮营收6.89亿美元，同比增长84.1%，其它CNS产品总销售额15.53亿美元，同比下降10.4%。4）抗肿瘤领域，全年营收176.61亿美元，同比增长10.5%。其中西达基奥仑赛（CARVYKTI）营收亿美元，相比去年增加3.67亿美元；达雷木单抗销售额97.44亿美元，同比增长22.2%；阿帕他胺销售额23.87亿美元，同比增长26.9%；依鲁替尼（IMBRUVICA）营收32.64亿美元，同比下降13.7%；阿比特龙（ZYTIGA）销售额8.87亿美元，同比下降44.9%，其它所有抗肿瘤产品营收8.79亿美元，同比增长4.41亿美元。5）肺动脉高压治疗管线总营收38.15亿美元，同比增长11.6%。其中Opsumit(马西替坦)营收19.73亿美元，同比增长10.6%；赛乐西帕（UPTRAVI）销售额15.82亿美元，同比增长19.7%，其它产品总销售额2.6亿美元，同比下降16.7%。6）心血管管线全年总营收36.71亿美元，同比下降5.5%。该管线的主要产品为利伐沙班（XARELTO），全年销售额为23.65亿美元（仅拥有美国销售权益），同比下降4.4%，其它全部心血管产品总销售额13.06亿美元，同比下降7.6%。强生主要产品销售额如下表所示（单位：百万美元）商品名2023年销售额2022年销售额REMICADE1,8392,343SIMPONI / SIMPONI ARIA2,1972,184STELARA10,8589,723TREMFYA3,1472668COVID-19 VACCINE1,1172,179EDURANT 1,1501,008PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA1,8541,943CONCERTA 783644INVEGA  SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA4,1154,140SPRAVATO689374CARVYKTI500133DARZALEX9,7447,977ERLEADA2,3871,881IMBRUVICA3,2641,784ZYTIGA8871,770OPSUMIT1,9731,783UPTRAVI1,5821,322XARELTO2,3652,473版权声明：本文转自药事纵横，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 活动推荐  3月 • NDC x 2024新药创新者峰会  关键词：  ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。