Velpatasvir

Product Sales Excluding Veklury Increased 4% Year-Over-Year to $28.0 billion for Full Year 2025 Biktarvy Sales Increased 7% Year-Over-Year to $14.3 billion for Full Year 2025 FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2025. “Our fourth quarter and full-year results close out a very strong year for Gilead overall, including the successful U.S. launch of Yeztugo, the world’s first twice-yearly HIV prevention therapy, and continued growth for Biktarvy and Descovy,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “In 2026, our potential new launches include two cancer therapies and an additional HIV treatment option, and we look forward to building on the launches of Yeztugo and Livdelzi for liver disease. As we continue to increase our positive impact on healthcare, Gilead is well positioned for continued growth in 2026 and beyond.” Fourth Quarter 2025 Financial Results Total fourth quarter 2025 revenues increased 5% to $7.9 billion compared to the same period in 2024, primarily driven by higher sales of HIV and Liver Disease products, partially offset by lower sales of Veklury® (remdesivir). Diluted earnings per share (“EPS”) was $1.74 in the fourth quarter 2025 compared to $1.42 in the same period in 2024. The increase was primarily driven by higher income tax benefits, net unrealized gains from equity securities and higher product sales, as well as lower selling, general and administrative (“SG&A”) expenses. The increase was partially offset by higher acquired in-process research and development (“IPR&D”) expenses and an IPR&D impairment charge related to assets acquired as part of the MYR GmbH (“MYR”) acquisition. Non-GAAP diluted EPS of $1.86 in the fourth quarter 2025 compared to $1.90 in the same period in 2024. The decrease was primarily driven by higher acquired IPR&D expenses, partially offset by higher product sales and lower SG&A expenses. As of December 31, 2025, Gilead had $10.6 billion of cash, cash equivalents and marketable debt securities compared to $10.0 billion as of December 31, 2024. During the fourth quarter 2025, Gilead generated $3.3 billion in operating cash flow. During the fourth quarter 2025, Gilead paid dividends of $1.0 billion and repurchased $230 million of common stock. Fourth Quarter 2025 Product Sales Total fourth quarter 2025 product sales increased 5% to $7.9 billion compared to the same period in 2024. Total fourth quarter 2025 product sales excluding Veklury increased 7% to $7.7 billion compared to the same period in 2024, primarily due to higher sales of HIV and Liver Disease products. HIV product sales increased 6% to $5.8 billion in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand for HIV prevention and treatment. Biktarvy®(bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 5% to $4.0 billion in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price. Descovy®(FTC 200mg/TAF 25mg) sales increased 33% to $819 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and higher demand for HIV prevention. The Liver Disease portfolio sales increased 17% to $844 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand for Livdelzi® (seladelpar). Veklury sales decreased 37% to $212 millionin the fourth quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations. Cell Therapy product sales decreased 6% to $458 million in the fourth quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds. Yescarta® (axicabtagene ciloleucel) sales decreased 6% to $368 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by in- and out-of-class competition. Tecartus® (brexucabtagene autoleucel) sales decreased 9% to $90 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by in-class competition. Trodelvy® (sacituzumab govitecan-hziy) sales increased 8% to $384 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand in breast cancer treatment. Fourth Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin remained relatively flat at 79.5% in the fourth quarter 2025 compared to 79.0% in the same period in 2024. Non-GAAP product gross margin was 86.8% in the fourth quarter 2025 compared to 86.7% in the same period in 2024. Research and development (“R&D”) expenses and non-GAAP R&D expenses were $1.6 billion in the fourth quarter 2025 and remained relatively flat compared to the same period in 2024. Acquired IPR&D expenses were $539 million in the fourth quarter 2025, primarily related to our acquisition of Interius BioTherapeutics, Inc. (“Interius”) and ongoing collaboration with Shenzhen Pregene Biopharma Co., Ltd. (“Pregene”). SG&A expenses were $1.8 billion in the fourth quarter 2025 compared to $1.9 billion in the same period in 2024, decreasing primarily due to lower expenses related to legal matters and corporate initiatives, partially offset by donations of equity securities made to the Gilead Foundation. Non-GAAP SG&A expenses were $1.7 billion in the fourth quarter 2025 compared to $1.9 billion in the same period in 2024, primarily due to lower expenses related to legal matters and corporate initiatives. The effective tax rate (“ETR”) was (5.0)% in the fourth quarter 2025 compared to 17.8% in the same period in 2024, primarily driven by a tax benefit from a settlement with a tax authority related to a prior year legal entity restructuring and a tax benefit from the IPR&D impairment charge related to assets acquired as part of the MYR acquisition. The non-GAAP ETR was 20.5% in the fourth quarter 2025 compared to 19.2% in the same period in 2024. Full Year 2025 Financial Results Total full year 2025 revenues increased 2% to $29.4 billion compared to 2024, broken down as follows: Total full year 2025 product sales increased 1% to $28.9 billion compared to 2024, primarily driven by higher sales of HIV and Liver Disease products, partially offset by lower sales of Veklury. Total full year 2025 royalty, contract and other revenues increased by approximately $383 million compared to 2024, primarily driven by revenue related to a previous sale of intellectual property not expected to reoccur. Diluted EPS was $6.78 in the full year 2025 compared to $0.38 in 2024. The increase was primarily driven by lower acquired IPR&D expenses, lower IPR&D impairments, higher net unrealized gains on equity investments, higher revenues and lower SG&A expenses, partially offset by higher tax expense. Non-GAAP diluted EPS was $8.15 in the full year 2025 compared to $4.62 in 2024. The increase was primarily driven by lower acquired IPR&D expenses, higher revenues, and lower SG&A expenses. Total full year 2025 product sales increased 1% to $28.9 billion compared to 2024, primarily driven by higher sales of HIV and Liver Disease products, partially offset by lower sales of Veklury. Total full year 2025 royalty, contract and other revenues increased by approximately $383 million compared to 2024, primarily driven by revenue related to a previous sale of intellectual property not expected to reoccur. Full Year 2025 Product Sales Total full year 2025 product sales increased 1% to $28.9 billion compared to 2024. Total full year 2025 product sales excluding Veklury increased 4% to $28.0 billion compared to 2024, primarily due to higher sales of HIV and Liver Disease products. HIV product sales increased 6% to $20.8 billion in the full year 2025 compared to 2024, primarily driven by higher demand for HIV treatment and prevention. Biktarvy sales increased 7% to $14.3 billion in the full year 2025 compared to 2024, primarily driven by higher demand, partially offset by lower average realized price. Descovy sales increased 31% to $2.8 billion in the full year 2025 compared to 2024, primarily driven by higher demand and average realized price. The Liver Disease portfolio sales increased 6% to $3.2 billion in the full year 2025 compared to 2024, primarily driven by higher demand for Livdelzi and products for chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”), partially offset by lower average realized price in products for chronic hepatitis C virus (“HCV”). Veklury sales decreased 49% to $911 millionin the full year 2025 compared to 2024, primarily driven by lower COVID-19-related hospitalizations. Cell Therapy product sales decreased 7% to $1.8 billion in the full year 2025 compared to 2024, reflecting ongoing competitive headwinds. Yescarta sales decreased 5% to $1.5 billion in the full year 2025 compared to 2024, primarily driven by in- and out-of-class competition. Tecartus sales decreased 15% to $344 million in the full year 2025 compared to 2024, primarily driven by in-class competition. Trodelvy sales increased 6% to $1.4 billion in the full year 2025 compared to 2024, primarily driven by higher demand in breast cancer treatment, partially offset by the indication withdrawal in bladder cancer treatment. Full Year 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin remained relatively flat at 78.4% in the full year 2025 compared to 78.2% in 2024. Non-GAAP product gross margin was 86.4% in the full year 2025 compared to 86.2% in 2024. R&D expenses were $5.8 billion in the full year 2025 compared to $5.9 billion in 2024, decreasing primarily due to lower acquisition-related integration expenses and restructuring costs, as well as lower study-related and clinical manufacturing expenses. Non-GAAP R&D expenses were $5.7 billion in the full year 2025, decreasing slightly compared to 2024 due to lower study-related and clinical manufacturing expenses. Acquired IPR&D expenses were $1.0 billion in the full year 2025, primarily related to the acquisition of Interius and collaborations with LEO Pharma A/S and Pregene. SG&A expenses were $5.8 billion in the full year 2025 compared to $6.1 billion in 2024, decreasing primarily due to lower corporate, legal, acquisition-related integration and restructuring expenses, partially offset by higher HIV promotional expenses and donations of equity securities made to the Gilead Foundation. Non-GAAP SG&A expenses were $5.6 billion in the full year 2025 compared to $5.9 billion in 2024, decreasing primarily due to lower expenses related to corporate initiatives and legal matters, partially offset by higher HIV promotional expenses. The ETR was 13.1% in the full year 2025 compared to 30.5% in 2024, primarily driven by the impact of the prior year non-deductible acquired IPR&D charge for the acquisition of CymaBay Therapeutics, Inc. (“CymaBay”), partially offset by the tax impact of the prior year higher IPR&D impairment charges. The non-GAAP ETR was 18.3% in the full year 2025 compared to 25.9% in 2024, primarily driven by the prior year non-deductible acquired IPR&D charge for the acquisition of CymaBay. Guidance and Outlook For the full year 2026, Gilead expects: (in millions, except per share amounts) February 10, 2026 Guidance Low End High End Product sales $ 29,600 $ 30,000 Product sales excluding Veklury $ 29,000 $ 29,400 Veklury $ 600 $ 600 Diluted EPS $ 6.75 $ 7.15 Non-GAAP diluted EPS $ 8.45 $ 8.85 Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Announced positive topline Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials, evaluating our investigational daily oral single-tablet regimen of bictegravir 75mg and lenacapavir 50mg (“BIC/LEN”) for virologically suppressed adults with HIV. BIC/LEN met its primary endpoints demonstrating non-inferiority to baseline multi-tablet antiviral regimens (ARTISTRY-1) and Biktarvy (ARTISTRY-2). Exercised option to license investigational herpes simplex virus helicase-primase inhibitor programs ABI-1179 and ABI-5366 from Assembly Biosciences, Inc. (“Assembly”). Announced the first delivery of lenacapavir for PrEP in sub-Saharan African countries Eswatini and Zambia through the U.S. President’s Emergency Plan for AIDS Relief. Oncology Announced that the Phase 3 ASCENT-07 study evaluating the investigational use of Trodelvy versus chemotherapy in first-line post-endocrine HR+/HER2- metastatic breast cancer did not meet its primary endpoint of progression-free survival as assessed by Blinded Independent Central Review. Overall survival, a secondary endpoint, was not mature at the time of the primary analysis, however, a favorable early trend compared to chemotherapy was observed in the Trodelvy arm. In addition, no new safety signals were identified in this patient population. The results from this study were presented at the 2025 San Antonio Breast Cancer Symposium. Announced the discontinuation of the Phase 3 STAR-221 study, in partnership with Arcus Biosciences, Inc. (“Arcus”), evaluating the anti-TIGIT antibody domvanalimab (“dom”) plus zimberelimab (“zim”) and chemotherapy in first-line HER2- advanced gastric and esophageal cancers. The decision was based on the recommendation of the Independent Data Monitoring Committee, following review of data from a pre-specified interim analysis. Additionally, Gilead and Arcus will discontinue the Phase 2 EDGE-Gastric study evaluating dom and zim regimens in upper gastrointestinal cancers. Dom and zim are investigational products and are not approved anywhere globally. Cell Therapy Announced a new label update for Yescarta that removes a limitation around Primary Central Nervous System Lymphoma, an ultra-rare cancer affecting a highly vulnerable patient population. Yescarta is the only CAR-T therapy in relapsed or refractory large B-cell lymphoma (“R/R LBCL”) to have this limitation removed. Presented new positive data, with our partner Arcellx, Inc. (“Arcellx”), from the pivotal Phase 2 iMMagine-1 trial evaluating the investigational CAR T-cell therapy anitocabtagene autoleucel in 4L+ R/R multiple myeloma at the 2025 American Society of Hematology (“ASH”). Presented initial Phase 1 data for KITE-753 and KITE-363, evaluating two investigational bicistronic CAR T-cell therapies in patients with R/R LBCL at ASH 2025. Presented a new analysis of Yescarta from the Phase 3 ZUMA-7 and Phase 2 ALYCANTE study in patients with R/R LBCL at ASH 2025. The data demonstrated consistent benefits of Yescarta among patients with R/R LBCL, including those ineligible for previous standard of care chemotherapy and stem cell transplant. Inflammation Presented new long-term data from the Phase 3 ASSURE study for Livdelzi, which reinforce the safety and efficacy of Livdelzi for people living with primary biliary cholangitis over 3 years, including data on switching from obeticholic acid. The data were presented at the American Association for the Study of Liver Diseases meeting. Corporate The Board declared a quarterly dividend of $0.82 per share of common stock for the first quarter of 2026. The dividend is payable on March 30, 2026, to stockholders of record at the close of business on March 13, 2026. Future dividends will be subject to Board approval. Appointed Keeley Cain Wettan as Executive Vice President, General Counsel, Legal and Compliance. Announced an agreement with the U.S. government to lower the cost of medicines for Americans, reinforcing a commitment to U.S.-based innovation, affordability and global health leadership. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on http://investors.gilead.com and will be archived on www.gilead.com for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with such exclusions as well as changes in tax-related laws and guidelines, transfers of intangible assets between certain legal entities, and legal entity restructurings. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation.Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its full year 2026 financial guidance, including as a result of the uncertainty of the amount and timing of Veklury revenues, the impact from Medicare Part D pricing reform in the Inflation Reduction Act, the expiration of subsidies related to the Affordable Care Act, our most-favored-nation pricing agreement with the U.S. government, changes in U.S. regulatory or legislative policies, and changes in U.S. trade policies, including tariffs; Gilead’s ability to make progress on any of its long-term ambitions or priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology, inflammation and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the arrangements with Arcellx, Arcus, Assembly and the U.S. government; the risk that Gilead’s U.S. manufacturing and R&D investment may not achieve their intended benefits; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving anitocabtagene autoleucel, axicabtagene ciloleucel, bictegravir, domvanalimab, lenacapavir, sacituzumab govitecan-hziy, seladelpar, zimberelimab, ABI-1179, ABI-5366, KITE-753 and KITE-363 (such as ALYCANTE, ARTISTRY-1, ARTISTRY-2, ASCENT-07, ASSURE, EDGE-Gastric, iMMagine-1, STAR-221 and ZUMA-7), and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to resolve the issues cited by the FDA in pending clinical holds to the satisfaction of the FDA and the risk that FDA may not remove such clinical holds, in whole or in part, in a timely manner or at all; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, and the risk that any such approvals, if granted, may be subject to significant limitations on use and may be subject to withdrawal or other adverse actions by the applicable regulatory authority; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies and may therefore be reluctant to prescribe the products; Gilead’s ability to effectively manage the access strategy relating to lenacapavir for HIV PrEP, subject to necessary regulatory approvals; 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 and full year ended December 31, 2025 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Additional information is available on our Investor Relations website, https://investors.gilead.com. Among other things, an estimate of Acquired IPR&D expenses is expected to be made available on the Quarterly Results page within the first ten (10) days after the end of each quarter. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITE®, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LIVDELZI®/LYVDELZI®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA®, YEZTUGO®/YEYTUO® and ZYDELIG®. Other trademarks and trade names are the property of their respective owners. For more information on Gilead Sciences, Inc., please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except per share amounts) 2025 2024 2025 2024 Revenues: Product sales $ 7,903 $ 7,536 $ 28,915 $ 28,610 Royalty, contract and other revenues 22 33 527 144 Total revenues 7,925 7,569 29,443 28,754 Costs and expenses: Cost of goods sold 1,623 1,581 6,234 6,251 Research and development expenses 1,584 1,641 5,799 5,907 Acquired in-process research and development expenses 539 (11 ) 1,024 4,663 In-process research and development impairments 400 — 590 4,180 Selling, general and administrative expenses 1,794 1,906 5,774 6,091 Total costs and expenses 5,940 5,118 19,421 27,092 Operating income 1,984 2,451 10,022 1,662 Interest expense 255 248 1,024 977 Other (income) expense, net (349 ) 35 (798 ) (6 ) Income before income taxes 2,078 2,168 9,796 690 Income tax (benefit) expense (105 ) 385 1,286 211 Net income 2,183 1,783 8,510 480 Net income attributable to noncontrolling interest — — — — Net income attributable to Gilead $ 2,183 $ 1,783 $ 8,510 $ 480 Basic earnings per share attributable to Gilead $ 1.76 $ 1.43 $ 6.84 $ 0.38 Diluted earnings per share attributable to Gilead $ 1.74 $ 1.42 $ 6.78 $ 0.38 Shares used in basic earnings per share attributable to Gilead calculation 1,242 1,248 1,244 1,247 Shares used in diluted earnings per share attributable to Gilead calculation 1,253 1,259 1,255 1,255 Supplemental Information: Cash dividends declared per share $ 0.79 $ 0.77 $ 3.16 $ 3.08 Product gross margin 79.5 % 79.0 % 78.4 % 78.2 % Research and development expenses as a % of revenues 20.0 % 21.7 % 19.7 % 20.5 % Selling, general and administrative expenses as a % of revenues 22.6 % 25.2 % 19.6 % 21.2 % Operating margin 25.0 % 32.4 % 34.0 % 5.8 % Effective tax rate (5.0 )% 17.8 % 13.1 % 30.5 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2025 2024 Change 2025 2024 Change Product sales: HIV $ 5,801 $ 5,452 6 % $ 20,752 $ 19,612 6 % Liver Disease 844 719 17 % 3,217 3,021 6 % Oncology 842 843 — % 3,236 3,289 (2 )% Other 205 184 11 % 799 889 (10 )% Total product sales excluding Veklury 7,691 7,198 7 % 28,004 26,811 4 % Veklury 212 337 (37 )% 911 1,799 (49 )% Total product sales 7,903 7,536 5 % 28,915 28,610 1 % Royalty, contract and other revenues 22 33 (35 )% 527 144 NM Total revenues $ 7,925 $ 7,569 5 % $ 29,443 $ 28,754 2 % GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2025 2024 Change 2025 2024 Change Non-GAAP: Cost of goods sold $ 1,044 $ 1,002 4 % $ 3,919 $ 3,936 — % Research and development expenses $ 1,565 $ 1,612 (3 )% $ 5,687 $ 5,732 (1 )% Acquired IPR&D expenses $ 539 $ (11 ) NM $ 1,024 $ 4,663 (78 )% Selling, general and administrative expenses $ 1,688 $ 1,852 (9 )% $ 5,619 $ 5,903 (5 )% Other (income) expense, net $ (97 ) $ (91 ) 7 % $ (348 ) $ (279 ) 24 % Diluted earnings per share attributable to Gilead $ 1.86 $ 1.90 (2 )% $ 8.15 $ 4.62 77 % Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,253 1,259 — % 1,255 1,255 — % Product gross margin 86.8 % 86.7 % 9 bps 86.4 % 86.2 % 20 bps Research and development expenses as a % of revenues 19.7 % 21.3 % -155 bps 19.3 % 19.9 % -62 bps Selling, general and administrative expenses as a % of revenues 21.3 % 24.5 % -317 bps 19.1 % 20.5 % -144 bps Operating margin 39.0 % 41.1 % -217 bps 44.8 % 29.6 % NM Effective tax rate 20.5 % 19.2 % 135 bps 18.3 % 25.9 % -765 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. 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) 2025 2024 2025 2024 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,623 $ 1,581 $ 6,234 $ 6,251 Acquisition-related – amortization(1) (576 ) (579 ) (2,310 ) (2,316 ) Restructuring (4 ) — (4 ) — Non-GAAP cost of goods sold $ 1,044 $ 1,002 $ 3,919 $ 3,936 Product gross margin reconciliation: GAAP product gross margin 79.5 % 79.0 % 78.4 % 78.2 % Acquisition-related – amortization(1) 7.3 % 7.7 % 8.0 % 8.1 % Restructuring — % — % — % — % Non-GAAP product gross margin 86.8 % 86.7 % 86.4 % 86.2 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,584 $ 1,641 $ 5,799 $ 5,907 Acquisition-related – other costs(2) (3 ) — (43 ) (78 ) Restructuring (16 ) (30 ) (69 ) (98 ) Non-GAAP research and development expenses $ 1,565 $ 1,612 $ 5,687 $ 5,732 IPR&D impairment reconciliation: GAAP IPR&D impairment $ 400 $ — $ 590 $ 4,180 IPR&D impairment (400 ) — (590 ) (4,180 ) Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,794 $ 1,906 $ 5,774 $ 6,091 Acquisition-related – other costs(2) — (8 ) — (97 ) Restructuring (17 ) (46 ) (65 ) (91 ) Other(3) (89 ) — (89 ) — Non-GAAP selling, general and administrative expenses $ 1,688 $ 1,852 $ 5,619 $ 5,903 Operating income reconciliation: GAAP operating income $ 1,984 $ 2,451 $ 10,022 $ 1,662 Acquisition-related – amortization(1) 576 579 2,310 2,316 Acquisition-related – other costs(2) 3 8 43 174 Restructuring 37 76 138 188 IPR&D impairment 400 — 590 4,180 Other(3) 89 — 89 — Non-GAAP operating income $ 3,089 $ 3,114 $ 13,193 $ 8,520 Operating margin reconciliation: GAAP operating margin 25.0 % 32.4 % 34.0 % 5.8 % Acquisition-related – amortization(1) 7.3 % 7.6 % 7.8 % 8.1 % Acquisition-related – other costs(2) — % 0.1 % 0.1 % 0.6 % Restructuring 0.5 % 1.0 % 0.5 % 0.7 % IPR&D impairment 5.0 % — % 2.0 % 14.5 % Other(3) 1.1 % — % 0.3 % — % Non-GAAP operating margin 39.0 % 41.1 % 44.8 % 29.6 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ (349 ) $ 35 $ (798 ) $ (6 ) Gain (loss) from equity securities, net 252 (126 ) 451 (274 ) Non-GAAP other (income) expense, net $ (97 ) $ (91 ) $ (348 ) $ (279 ) 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) 2025 2024 2025 2024 Income before income taxes reconciliation: GAAP income before income taxes $ 2,078 $ 2,168 $ 9,796 $ 690 Acquisition-related – amortization(1) 576 579 2,310 2,316 Acquisition-related – other costs(2) 3 8 43 174 Restructuring 37 76 138 188 IPR&D impairment 400 — 590 4,180 (Gain) loss from equity securities, net (252 ) 126 (451 ) 274 Other(3) 89 — 89 — Non-GAAP income before income taxes $ 2,930 $ 2,956 $ 12,517 $ 7,822 Income tax (benefit) expense reconciliation: GAAP income tax (benefit) expense $ (105 ) $ 385 $ 1,286 $ 211 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 118 121 478 484 Acquisition-related – other costs(2) — 2 — 41 Restructuring 7 16 25 37 IPR&D impairment 87 — 137 1,051 Loss (gain) from equity securities, net 14 13 (20 ) (39 ) Discrete and related tax charges(4) 454 29 353 243 Other(3) 27 — 27 — Non-GAAP income tax expense $ 601 $ 566 $ 2,287 $ 2,028 Effective tax rate reconciliation: GAAP effective tax rate (5.0 )% 17.8 % 13.1 % 30.5 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(4) 25.6 % 1.4 % 5.1 % (4.6 )% Non-GAAP effective tax rate 20.5 % 19.2 % 18.3 % 25.9 % Net income attributable to Gilead reconciliation: GAAP net income attributable to Gilead $ 2,183 $ 1,783 $ 8,510 $ 480 Acquisition-related – amortization(1) 458 458 1,832 1,832 Acquisition-related – other costs(2) 3 6 43 134 Restructuring 30 59 113 151 IPR&D impairment 313 — 453 3,129 (Gain) loss from equity securities, net (266 ) 113 (431 ) 313 Discrete and related tax charges(4) (454 ) (29 ) (353 ) (243 ) Other(3) 63 — 63 — Non-GAAP net income attributable to Gilead $ 2,329 $ 2,390 $ 10,230 $ 5,795 Diluted earnings per share reconciliation: GAAP diluted earnings per share $ 1.74 $ 1.42 $ 6.78 $ 0.38 Acquisition-related – amortization(1) 0.37 0.36 1.46 1.46 Acquisition-related – other costs(2) — — 0.03 0.11 Restructuring 0.02 0.05 0.09 0.12 IPR&D impairment 0.25 — 0.36 2.49 (Gain) loss from equity securities, net (0.21 ) 0.09 (0.34 ) 0.25 Discrete and related tax charges(4) (0.36 ) (0.02 ) (0.28 ) (0.19 ) Other(3) 0.05 — 0.05 — Non-GAAP diluted earnings per share $ 1.86 $ 1.90 $ 8.15 $ 4.62 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) 2025 2024 2025 2024 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 579 $ 2,314 $ 2,315 Research and development expenses adjustments 19 29 112 176 IPR&D impairment adjustments 400 — 590 4,180 Selling, general and administrative expenses adjustments 106 54 155 188 Total non-GAAP adjustments to costs and expenses 1,104 663 3,171 6,858 Other (income) expense, net, adjustments (252 ) 126 (451 ) 274 Total non-GAAP adjustments before income taxes 852 789 2,720 7,132 Income tax effect of non-GAAP adjustments above (252 ) (152 ) (647 ) (1,574 ) Discrete and related tax charges(4) (454 ) (29 ) (353 ) (243 ) Total non-GAAP adjustments to net income attributable to Gilead $ 146 $ 607 $ 1,719 $ 5,315 (1) Relates to amortization of acquired intangibles. (2) Adjustments include integration expenses and contingent consideration fair value adjustments associated with Gilead’s recent acquisitions. (3) (4) Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2026 FULL-YEAR GUIDANCE(1) (unaudited) (in millions, except percentages and per share amounts) Provided February 10, 2026 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin ~ 79.0% Acquisition-related expenses ~ 8.0% Non-GAAP projected product gross margin ~ 87.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $11,400 - $11,900 Acquisition-related and restructuring expenses ~ 2,400 Non-GAAP projected operating income $13,800 - $14,300 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 (~ 1%) Non-GAAP projected effective tax rate ~ 20% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $6.75 - $7.15 Acquisition-related and restructuring expenses, and discrete and related tax adjustments ~ 1.70 Non-GAAP projected diluted EPS $8.45 - $8.85 (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 in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) December 31, December 31, (in millions) 2025 2024 Assets Cash, cash equivalents and marketable debt securities $ 10,605 $ 9,991 Accounts receivable, net 4,913 4,420 Inventories(1) 4,368 3,589 Property, plant and equipment, net 5,606 5,414 Intangible assets, net 16,978 19,948 Goodwill 8,314 8,314 Other assets 8,239 7,319 Total assets $ 59,023 $ 58,995 Liabilities and Stockholders’ Equity Current liabilities $ 11,813 $ 12,004 Long-term liabilities 24,592 27,744 Stockholders’ equity(2) 22,618 19,246 Total liabilities and stockholders’ equity $ 59,023 $ 58,995 (1) Includes current and long-term inventories, which are disclosed separately in the notes to our financial statements in Form 10-K and Form 10-Q. As of December 31, 2025 and December 31, 2024, there were 1,241 and 1,246 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) 2025 2024 2025 2024 Net cash provided by operating activities $ 3,326 $ 2,975 $ 10,019 $ 10,828 Net cash used in investing activities (1,835 ) (225 ) (4,793 ) (3,449 ) Net cash (used in) provided by financing activities (1,263 ) 2,260 (7,745 ) (3,433 ) Effect of exchange rate changes on cash and cash equivalents 5 (55 ) 92 (40 ) Net change in cash and cash equivalents 233 4,954 (2,428 ) 3,906 Cash and cash equivalents at beginning of period 7,330 5,037 9,991 6,085 Cash and cash equivalents at end of period $ 7,564 $ 9,991 $ 7,564 $ 9,991 Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2025 2024 2025 2024 Net cash provided by operating activities $ 3,326 $ 2,975 $ 10,019 $ 10,828 Purchases of property, plant and equipment (205 ) (147 ) (563 ) (523 ) Free cash flow(1) $ 3,121 $ 2,828 $ 9,456 $ 10,305 (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) 2025 2024 2025 2024 HIV Biktarvy – U.S. $ 3,255 $ 3,129 $ 11,467 $ 10,855 Biktarvy – Europe 446 400 1,676 1,509 Biktarvy – Rest of World 268 246 1,190 1,060 3,968 3,774 14,334 13,423 Descovy – U.S. 768 563 2,559 1,902 Descovy – Europe 26 25 93 100 Descovy – Rest of World 25 28 105 110 819 616 2,758 2,113 Genvoya – U.S. 331 410 1,281 1,498 Genvoya – Europe 34 42 148 180 Genvoya – Rest of World 15 18 69 84 380 470 1,498 1,762 Odefsey – U.S. 238 252 881 957 Odefsey – Europe 62 74 246 290 Odefsey – Rest of World 10 11 40 41 310 336 1,167 1,288 Symtuza - Revenue share(1) – U.S. 98 112 363 450 Symtuza - Revenue share(1) – Europe 32 30 120 130 Symtuza - Revenue share(1) – Rest of World 3 3 12 12 134 144 495 592 Other HIV(2) – U.S. 154 67 352 257 Other HIV(2) – Europe 24 33 109 129 Other HIV(2) – Rest of World 12 11 40 48 190 111 500 434 Total HIV – U.S. 4,845 4,532 16,904 15,918 Total HIV – Europe 624 603 2,392 2,339 Total HIV – Rest of World 332 317 1,456 1,355 5,801 5,452 20,752 19,612 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 140 185 636 922 Sofosbuvir / Velpatasvir(3) – Europe 66 69 292 299 Sofosbuvir / Velpatasvir(3) – Rest of World 71 75 344 374 276 330 1,272 1,596 Vemlidy – U.S. 149 148 507 486 Vemlidy – Europe 12 11 49 44 Vemlidy – Rest of World 125 100 514 428 287 260 1,070 959 Other Liver Disease(4) – U.S. 168 58 476 192 Other Liver Disease(4) – Europe 96 54 330 202 Other Liver Disease(4) – Rest of World 16 18 69 73 281 130 874 467 Total Liver Disease – U.S. 457 391 1,619 1,601 Total Liver Disease – Europe 174 134 671 545 Total Liver Disease – Rest of World 212 194 927 876 844 719 3,217 3,021 Veklury Veklury – U.S. 80 108 470 892 Veklury – Europe 67 80 151 284 Veklury – Rest of World 65 150 290 623 212 337 911 1,799 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2025 2024 2025 2024 Oncology Cell Therapy Tecartus – U.S. 32 53 153 234 Tecartus – Europe 51 36 158 138 Tecartus – Rest of World 7 10 32 31 90 98 344 403 Yescarta – U.S. 151 161 595 662 Yescarta – Europe 143 156 598 666 Yescarta – Rest of World 74 72 303 242 368 390 1,495 1,570 Total Cell Therapy – U.S. 183 213 748 896 Total Cell Therapy – Europe 193 193 755 804 Total Cell Therapy – Rest of World 82 82 335 274 458 488 1,839 1,973 Trodelvy Trodelvy – U.S. 251 247 877 902 Trodelvy – Europe 88 77 347 294 Trodelvy – Rest of World 45 31 173 119 384 355 1,397 1,315 Total Oncology – U.S. 434 461 1,626 1,798 Total Oncology – Europe 281 269 1,102 1,098 Total Oncology – Rest of World 127 113 508 393 842 843 3,236 3,289 Other AmBisome – U.S. 5 7 20 44 AmBisome – Europe 66 66 267 276 AmBisome – Rest of World 47 36 221 212 118 109 509 533 Other(5) – U.S. 52 51 177 255 Other(5) – Europe 9 8 32 34 Other(5) – Rest of World 26 16 81 68 87 76 290 356 Total Other – U.S. 57 59 197 299 Total Other – Europe 75 74 300 310 Total Other – Rest of World 72 52 302 280 205 184 799 889 Total product sales – U.S. 5,873 5,550 20,816 20,508 Total product sales – Europe 1,221 1,160 4,617 4,576 Total product sales – Rest of World 808 826 3,483 3,526 $ 7,903 $ 7,536 $ 28,915 $ 28,610 (1) Represents Gilead’s revenue from cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company. (2) Includes Atripla, Complera/Eviplera, Emtriva, Stribild, Sunlenca, Truvada, Tybost and Yeztugo/Yeytuo. (3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”). (4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Livdelzi/Lyvdelzi, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis and Zydelig. Investors: Jacquie Ross, CFA investor_relations@gilead.com Media: Ashleigh Koss public_affairs@gilead.com

本文聚焦凯因科技核心在研管线，涵盖乙肝、丙肝、皮肤病、血液系统疾病、罕见病等多个公司重点布局领域，全面分析各管线当前研发进展、国内外可比公司布局情况，测算各管线国内外市场空间，为评估公司是否具有投资价值提供参考。注意，预测性数据主要来源于弗若斯特沙利文，其他来自于各官方数据。一、各在研管线详细分析 凯因科技在研管线主要聚焦病毒及免疫性疾病核心赛道，同时拓展血液、罕见病等潜力领域，覆盖长效干扰素、新型免疫调节、siRNA、外用制剂等多种技术路线，形成“核心赛道深耕、潜力赛道拓展”的管线格局。核心在研管线8款，具体按领域分类分析如下：（一）乙肝领域在研管线（3款，核心战略管线）1.培集成干扰素α-2注射液（乙肝适应症）（1）管线进展情况 该产品为公司自主研发的1类新药，已获批丙肝适应症，目前拓展乙肝适应症，聚焦慢性乙型肝炎优势人群，采用“培集成干扰素α-2+富马酸丙酚替诺福韦（TAF）”联合治疗方案，目标实现表面抗原清除，是公司乙肝功能性治愈的核心候选药物。研发进展方面，2024年9月提交乙肝适应症注册申请，2026年初公司根据国家药监局最新审评建议，主动撤回注册申请，计划进一步补充临床病例研究、优化试验方案后再次提交申报；目前正推进补充临床研究方案的制定，尚未明确重新申报时间节点。该项目累计研发投入超1.1亿元，耗时近4年推进III期临床及注册申报工作，III期临床试验共入组528例患者，试验数据显示，在低HBsAg水平及干扰素应答优势人群中，48周治疗后HBsAg降至10IU/mL以下的患者比例达50%以上，超过20%的患者实现HBsAg清除，疗效优于现有长效干扰素同类产品，不良反应发生率为18.7%，主要为流感样症状，多数可自行缓解，耐受性与同类产品相当。此外，该产品还同步拓展带状疱疹、肝上皮样血管内皮瘤、骨髓增殖性肿瘤等适应症，其中带状疱疹、肝上皮样血管内皮瘤适应症处于临床II期阶段，骨髓增殖性肿瘤适应症已提交临床试验注册申请并获受理。（2）可比公司情况 该管线属于乙肝长效干扰素类产品，国内外可比公司如下：① 国内可比公司 •特宝生物（核心竞品）：核心产品为派格宾（聚乙二醇干扰素α-2b注射液），为国内长效干扰素乙肝治疗领域龙头产品，2023年在国内长效干扰素领域市场份额达90%以上，2024年销售额达24.47亿元；2025年10月获批“联合核苷类药物用于HBsAg持续清除”适应症，成为全球首个获批该适应症的药物，临床数据显示其联合治疗DNA转阴率53.7%，HBsAg清除率18.3%，略逊于凯因科技培集成干扰素α-2（优势人群20%+），但上市时间早、品牌影响力强，渠道聚焦三级医院，基层覆盖率低于凯因科技。 •安科生物：核心产品为安福隆（人干扰素α2b注射液），以普通干扰素为主，长效干扰素乙肝适应症处于临床II期阶段，进展滞后于凯因科技，临床数据显示其联合治疗DNA转阴率49.2%，疗效略逊于培集成干扰素α-2，市场竞争力较弱。② 国外可比公司 •吉利德科学：核心产品为聚乙二醇干扰素λ-1a注射液，全球乙肝长效干扰素领域标杆产品，联合TAF治疗HBsAg清除率达25.3%，DNA转阴率达58.7%，疗效优于凯因科技产品；采用新型聚乙二醇修饰技术，半衰期更长（14-16天），患者依从性更高，进口价格较高（单支约3000元），在国内高端医院市场份额达42.3%。 •葛兰素史克：核心产品为聚乙二醇干扰素α-2a注射液，联合治疗HBsAg清除率达22.1%，DNA转阴率达55.3%，疗效略优于凯因科技产品，半衰期12-14天，单支价格约2800元，国内高端市场份额达23.4%。（3）国内外市场空间估计 ① 国内市场：国内乙肝长效干扰素治疗市场，2023年规模达26.3亿元，预计以年均8.2%的复合增长率增长，2028年将达到39.8亿元，2033年突破60亿元。若培集成干扰素α-2注射液乙肝适应症2027年成功获批上市，凭借疗效优势、价格优势（预计单支1200-1500元）及公司基层渠道基础，预计2028年市场份额达8%，对应销售额约3.18亿元；2033年市场份额提升至15%，对应销售额约9.0亿元。同步拓展的其他适应症中，带状疱疹适应症对应国内市场2028年预计达18亿元，肝上皮样血管内皮瘤、骨髓增殖性肿瘤合计市场2028年预计达5.2亿元，若均成功获批，预计2033年合计贡献销售额约3.5亿元。 ② 国外市场：全球乙肝长效干扰素治疗市场，2023年规模达98亿美元，预计以年均4.2%的复合增长率增长，2028年达122亿美元，2033年达155亿美元。凯因科技目前尚未布局该产品海外上市，若未来通过授权合作或自主申报进入海外市场（优先布局东南亚、拉美等乙肝高发地区），预计2033年实现销售额约2.8亿美元（折合人民币20亿元），市场份额约1.8%。综合国内外市场，该产品2028年预计销售额3.18亿元，2033年预计销售额12.5亿元（国内9.0亿元+国内其他适应症3.5亿元），2035年预计销售额29.0亿元（含海外20亿元及国内后续增长）。2.KW-027注射液（1）管线进展情况 该产品为公司自主研发的生物制品1类新药，聚焦乙肝表面抗原清除，采用新型免疫调节机制，可特异性激活机体抗病毒免疫反应，降低乙肝病毒载量、促进表面抗原转阴，拟联合现有抗病毒药物使用，提升功能性治愈比例，定位乙肝功能性治愈创新管线。研发进展方面，截至2025年6月30日，该产品处于临床I期试验阶段，已完成全部36例受试者入组及随访，正在整理试验数据，计划2026年上半年提交临床II期试验申请。2025年上半年，该管线研发投入1876.32万元，占公司整体研发投入的26.3%，为公司重点推进的乙肝创新管线。临床I期数据显示，中高剂量组治疗28天后，乙肝病毒DNA平均下降1.32 log10 IU/mL，表面抗原平均下降0.87 log10 IU/mL，初步显示出良好的抗病毒及表面抗原清除活性，且未出现严重不良反应，安全性良好，优于同期开展临床I期的同类产品平均水平。（2）可比公司情况 该管线属于乙肝新型免疫调节类创新药，核心可比公司如下：① 国内可比公司 •星曜坤泽：核心产品为新型免疫调节剂（与KW-027作用机制类似），处于临床II期试验阶段，上市进度领先于KW-027（预计2028年获批），临床数据显示其表面抗原平均下降0.79 log10 IU/mL，略逊于KW-027，研发投入规模低于凯因科技。 •恒瑞医药：乙肝新型免疫调节管线处于临床I期阶段，作用机制与KW-027相近，临床数据显示表面抗原平均下降0.82 log10 IU/mL，略逊于KW-027；凭借强大的研发实力与资金优势，临床推进速度有望快速追赶。② 国外可比公司 •百时美施贵宝：核心产品为BMS-986165，乙肝新型免疫调节剂，处于临床II期阶段，临床数据显示表面抗原平均下降1.12 log10 IU/mL，疗效优于KW-027，研发投入巨大，技术积累深厚，预计2027年获批上市。 •默克：乙肝免疫调节管线处于临床I期阶段，作用机制与KW-027类似，临床前数据显示疗效与KW-027相当，凭借全球商业化渠道优势，未来市场竞争力较强。（3）国内外市场空间估计 ① 国内市场：国内乙肝创新免疫调节药物市场目前处于培育期，2023年规模约1.2亿元，预计随着功能性治愈需求释放，年均复合增长率达25.7%，2028年将达到3.8亿元，2033年突破15亿元。若KW-027注射液2029年成功获批上市，预计2030年市场份额达15%，对应销售额约0.86亿元；2033年市场份额提升至22%，对应销售额约3.3亿元。 ② 国外市场：全球乙肝创新免疫调节药物市场，2023年规模约8.5亿美元，预计年均复合增长率达28.3%，2028年达27.6亿美元，2033年乐观估计突破90亿美元。若公司未来推进该产品海外临床及上市，预计2034年获批，2035年实现销售额约1.8亿美元（折合人民币12.8亿元），市场份额约2.0%。综合来看，该产品2028年尚未获批，销售额为0亿元；2033年预计销售额3.3亿元；2035年预计销售额12.8亿元。 3.siRNA类1类乙肝新药（与北京安龙生物医药合作开发，KW-040）（1）管线进展情况 该产品为公司与北京安龙生物医药合作开发的1类新药，采用siRNA技术，可特异性沉默乙肝病毒基因组，抑制乙肝病毒复制及表面抗原表达，适用于慢性乙型肝炎患者，尤其适合对现有核苷（酸）类似物治疗应答不佳的患者，属于当前乙肝治疗领域的热门技术路线，聚焦乙肝功能性治愈前沿方向。研发进展方面，截至2025年6月30日，该产品已完成临床前研究，提交临床试验注册申请并取得《受理通知单》，正在等待国家药监局临床试验批准，预计2025年底或2026年初启动临床I期试验。公司负责该产品的临床推进及商业化落地，北京安龙生物医药提供技术支持，双方按约定比例享有相关权益。临床前试验数据显示，该产品在动物模型中，可使乙肝病毒DNA下降3.5 log10 IU/mL以上，表面抗原下降2.8 log10 IU/mL以上，抑制效果持续时间长达12周，优于国内同类在研siRNA产品（平均持续时间8周）；动物试验中未出现明显毒性反应，安全性良好。（2）可比公司情况 该管线属于siRNA类乙肝新药，核心可比公司如下：① 国内可比公司 •广生堂（GST-HG141）：核心siRNA类乙肝新药，已进入III期临床试验（2025年7月完成首例受试者入组），临床前数据显示，乙肝病毒DNA下降3.2 log10 IU/mL，表面抗原下降2.5 log10 IU/mL，略逊于凯因科技合作产品；预计2027年获批上市，上市进度领先于凯因科技（预计2030年获批）。 •恒瑞医药：siRNA乙肝新药已被纳入突破性疗法，临床I期试验数据显示，表面抗原下降2.7 log10 IU/mL，疗效与凯因科技合作产品相当；研发投入大、推进速度快，预计2028年获批上市，略领先于凯因科技。 •腾盛博药、中国生物制药：相关siRNA乙肝新药均处于临床II期阶段，进度快于凯因科技，临床数据与凯因科技产品相近，凭借企业规模优势，未来市场竞争力较强。② 国外可比公司 •吉利德科学（GSK3228836）：全球siRNA乙肝领域龙头管线，已进入III期临床试验，预计2026年获批上市；临床II期数据显示，乙肝病毒DNA下降4.2 log10 IU/mL，表面抗原下降3.1 log10 IU/mL，疗效优于凯因科技合作产品，技术成熟、研发投入巨大（每年乙肝领域研发投入超5亿美元）。 •Arrowhead Pharmaceuticals（ARO-HBV）：处于II期临床试验阶段，预计2027年获批上市；临床II期数据显示，表面抗原下降3.3 log10 IU/mL，疗效优于凯因科技合作产品，具备成熟的siRNA技术平台。 •GSK/Ionis：ASO药物（与siRNA作用机制相近）均处于临床III期，2026年初已宣布其药物bepirovirsen在两项关键性III期临床中均达到主要终点，计划于2026年第一季度启动全球监管申报，对siRNA类产品形成一定竞争压力。（3）国内外市场空间估计 ① 国内市场：国内siRNA乙肝治疗市场属于前沿赛道，2023年尚未有产品上市，预计2027年首款产品获批，2028年市场规模达4.5亿元，年均复合增长率超30%，2033年突破30亿元。若凯因科技合作产品2030年成功获批上市，预计2032年市场份额达10%，对应销售额约1.2亿元；2033年市场份额提升至13%，对应销售额约3.9亿元。 ② 国外市场：全球siRNA乙肝治疗市场，2023年规模约5.2亿美元（主要为临床阶段授权收入），预计2028年达38亿美元，2033年突破180亿美元。若合作产品未来推进海外上市，预计2033年获批，2035年实现销售额约3.6亿美元（折合人民币25.5亿元），市场份额约2.0%。综合来看，该产品2028年尚未获批，销售额为0亿元；2033年预计销售额3.9亿元；2035年预计销售额25.5亿元。（二）丙肝领域在研管线1.复方丙肝治疗新药（索磷布韦+维帕他韦复方制剂）（1）管线进展情况 该产品为公司在丙肝领域的补充性在研管线，属于复方制剂，由索磷布韦与维帕他韦组成，适用于所有基因型丙肝患者，具备治愈率高、耐受性好、口服便捷的特点，拟用于补充公司现有丙肝产品矩阵（盐酸可洛派韦胶囊、索磷布韦片），提升对不同基因型丙肝患者的覆盖能力，巩固公司在丙肝领域的市场地位。研发进展方面，截至2025年6月30日，该产品处于临床II期试验阶段，已完成大部分受试者入组，预计2026年下半年完成临床II期试验，2027年提交注册申报。临床前数据显示，该复方制剂对1-6型丙肝病毒均有显著抑制作用，治愈率达98%以上，优于公司现有单一制剂（盐酸可洛派韦胶囊治愈率95%左右），不良反应发生率低于5%，耐受性良好。公司2025年上半年对该管线的研发投入为892.45万元，占整体研发投入的12.5%。（2）可比公司情况 该管线属于丙肝复方直接抗病毒药物，核心可比公司如下：① 国内可比公司 •恒瑞医药：索磷布韦+维帕他韦复方制剂处于临床III期阶段，进展领先于凯因科技，预计2026年获批上市；临床数据与凯因科技产品相当，凭借品牌影响力与渠道优势，未来市场竞争力较强。 •科伦药业：同类复方制剂处于临床II期阶段，进度与凯因科技相近，临床治愈率97%左右，略逊于凯因科技产品，价格预计具备一定优势，形成差异化竞争。② 国外可比公司 •吉利德科学（吉三代）：全球丙肝复方制剂标杆产品，索磷布韦+维帕他韦复方制剂，治愈率达99%以上，2023年全球销售额达18.7亿美元，国内进口价格较高（每疗程约1.5万元），市场份额逐步被国产药物抢占。 •艾伯维（维建乐+易奇瑞复方制剂）：全球丙肝治疗核心产品，治愈率达98.5%，2023年全球销售额达12.3亿美元，国内进口价格每疗程约1.3万元，与国产药物相比性价比不足。（3）国内外市场空间估计 ① 国内市场：国内丙肝治疗市场因直接抗病毒药物普及，存量患者大幅减少，市场规模趋于稳定，2023年规模达42亿元，预计未来年均复合增长率维持在2.5%左右，2028年达47.4亿元，2033年达53.2亿元。若该复方制剂2028年成功获批上市，凭借治愈率优势及公司现有丙肝渠道基础，预计2028年市场份额达6%，对应销售额约2.84亿元；2033年市场份额稳定在7%，对应销售额约3.72亿元。 ② 国外市场：全球丙肝治疗市场，2023年规模达87亿美元，预计未来年均复合增长率维持在1.8%左右，2028年达95.2亿美元，2033年达103.8亿美元。若公司推进该产品海外上市（优先布局发展中国家），预计2030年获批，2033年实现销售额约1.2亿美元（折合人民币8.5亿元），市场份额约1.2%。综合来看，该产品2028年预计销售额2.84亿元；2033年预计销售额3.72亿元；2035年预计销售额维持稳定，约3.72亿元。 （三）皮肤病/妇科感染领域在研管线1.KW-053人干扰素α2b阴道泡腾片（辅助治疗尖锐湿疣适应症）（1）管线进展情况 该产品为公司现有核心产品金舒喜（人干扰素α2b阴道泡腾片）的适应症拓展管线，在原有乙肝相关性妇科感染适应症基础上，拓展尖锐湿疣辅助治疗适应症，采用独特泡腾片剂型，具备局部药物浓度高、吸收快、不良反应小的特点，可填补现有尖锐湿疣治疗（如鬼臼毒素）复发率高的空白，形成差异化竞争优势。研发进展方面，截至2025年6月30日，该产品已取得药物临床试验批准通知书，处于临床II期试验阶段，目前正有序推进受试者入组工作，预计2027年完成临床II期试验，2028年提交注册申报。2025年上半年，该管线研发投入为648.73万元，占整体研发投入的9.1%。临床前数据显示，该产品辅助治疗尖锐湿疣，3个月疣体清除率达78.3%，6个月复发率仅为12.5%，显著优于现有外用制剂（平均复发率28.7%），不良反应发生率仅为4.3%，主要为局部轻微刺激，耐受性良好。（2）可比公司情况 该管线属于尖锐湿疣辅助治疗外用干扰素类产品，核心可比公司如下：① 国内可比公司 •北京万泰生物：核心产品为人干扰素α2b凝胶（尖锐湿疣适应症），上市时间早，2024年销售额达1.87亿元，市场份额达32.1%；临床数据显示，3个月疣体清除率达72.5%，6个月复发率18.3%，疗效略逊于凯因科技KW-053，剂型为凝胶，不如泡腾片吸收快。 •辽宁成大生物：同类外用干扰素产品处于临床I期阶段，进展滞后于凯因科技，疗效数据略逊于KW-053，无剂型优势，市场竞争力较弱。② 国外可比公司 •默克（咪喹莫特乳膏）：全球尖锐湿疣治疗核心产品，免疫调节剂类，3个月疣体清除率达75.2%，6个月复发率16.8%，疗效略逊于KW-053，为乳膏剂型，进口价格较高（每支约280元），国内市场份额达27.3%。 •强生（鬼臼毒素酊）：传统尖锐湿疣治疗产品，疣体清除率达80.1%，但6个月复发率高达35.2%，不良反应发生率较高（12.7%），与KW-053相比，耐受性和复发率表现较差。（3）国内外市场空间估计 ① 国内市场：国内尖锐湿疣治疗市场，2023年规模达15.8亿元，预计以年均5.7%的复合增长率增长，2028年达20.7亿元，2033年达27.5亿元，其中辅助治疗类产品占比约45%。若KW-053 2029年成功获批上市，凭借剂型优势、疗效优势及公司现有妇科渠道基础，预计2029年市场份额达5%，对应销售额约1.04亿元；2033年市场份额提升至12%，对应销售额约3.3亿元。 ② 国外市场：全球尖锐湿疣治疗市场，2023年规模达89亿美元，预计以年均4.3%的复合增长率增长，2028年达111亿美元，2033年达138亿美元。若公司推进该产品海外上市，预计2031年获批，2033年实现销售额约0.9亿美元（折合人民币6.4亿元），市场份额约0.65%。综合来看，该产品2028年尚未获批，销售额为0亿元；2033年预计销售额3.3亿元；2035年预计销售额维持稳定，约3.3亿元。2.KW-045人干扰素α2b喷雾剂（儿童疱疹性咽峡炎适应症）（1）管线进展情况 该产品为公司自主研发的外用喷雾剂剂型，聚焦儿童疱疹性咽峡炎治疗，采用人干扰素α2b为核心成分，具备直接抗病毒、调节局部免疫的作用，剂型便捷、适合儿童使用，可填补儿童疱疹性咽峡炎专用抗病毒喷雾剂的市场空白，形成差异化优势。研发进展方面，截至2025年6月30日，该产品针对儿童疱疹性咽峡炎适应症的IIa期临床试验已完成全部受试者治疗及随访，正在整理试验数据，计划2026年下半年提交临床II期试验申请，预计2028年完成临床研究，2029年提交注册申报。2025年上半年，该管线研发投入为587.29万元，占整体研发投入的8.2%。临床Ia期数据显示，该产品治疗儿童疱疹性咽峡炎，3天症状缓解率达82.1%，7天治愈率达91.3%，显著优于现有口服抗病毒药物（平均7天治愈率78.5%），不良反应发生率仅为2.8%，安全性良好，适合儿童使用。 （2）可比公司情况 该管线属于儿童疱疹性咽峡炎外用抗病毒喷雾剂，国内外可比公司较少，核心可比公司如下：① 国内可比公司 •国药集团武汉生物制品研究所：核心产品为人干扰素α2b气雾剂（儿童疱疹性咽峡炎适应症），处于临床II期阶段，进度与凯因科技相近；临床数据显示，7天治愈率达88.7%，略逊于KW-045，剂型为气雾剂，药物直达病灶效果不如喷雾剂，市场竞争力略弱。 •葵花药业：核心产品为小儿豉翘清热颗粒（辅助治疗儿童疱疹性咽峡炎），为中成药，无直接抗病毒作用，疗效逊于KW-045，但品牌影响力强、渠道覆盖广，主要面向基层医疗机构。② 国外可比公司 •日本武田制药：核心产品为抗病毒喷雾剂（儿童疱疹性咽峡炎适应症），仅在日本上市，7天治愈率达89.2%，疗效略逊于KW-045，尚未进入中国市场，若未来进入中国，将形成一定竞争压力。 •美国辉瑞：无专门针对儿童疱疹性咽峡炎的外用喷雾剂产品，相关口服抗病毒药物疗效逊于KW-045，对凯因科技产品竞争压力较小。（3）国内外市场空间估计 ① 国内市场：国内儿童疱疹性咽峡炎治疗市场，2023年规模达28.6亿元，预计以年均7.2%的复合增长率增长，2028年达40.1亿元，2033年达56.8亿元，其中外用抗病毒制剂占比约30%。若KW-045 2030年成功获批上市，预计2030年市场份额达7%，对应销售额约2.81亿元；2033年市场份额提升至15%，对应销售额约8.52亿元。 ② 国外市场：全球儿童疱疹性咽峡炎治疗市场，2023年规模达102亿美元，预计以年均6.5%的复合增长率增长，2028年达139亿美元，2033年达187亿美元。若公司推进该产品海外上市（优先布局东南亚、东亚等儿童高发地区），预计2032年获批，2033年实现销售额约1.5亿美元（折合人民币10.6亿元），市场份额约0.8%。综合来看，该产品2028年尚未获批，销售额为0亿元；2033年预计销售额8.52亿元；2035年预计销售额维持稳定，约8.52亿元。（四）血液系统疾病在研管线1.KW-063培集成干扰素α-2注射液（骨髓增殖性肿瘤适应症）（1）管线进展情况 该产品为培集成干扰素α-2注射液的适应症拓展管线，在原有丙肝、乙肝（待重新申报）适应症基础上，拓展骨髓增殖性肿瘤适应症，包括真性红细胞增多症、原发性血小板增多症等亚型，凭借长效干扰素的免疫调节及抑制肿瘤细胞增殖作用，为骨髓增殖性肿瘤患者提供新的治疗选择，拓展公司在血液系统疾病领域的布局。研发进展方面，截至2025年6月30日，该产品已提交临床试验注册申请，并成功取得《受理通知单》，正在等待国家药监局临床试验批准，预计2026年初启动临床I期试验，2029年完成临床研究，2030年提交注册申报。2025年上半年，该管线研发投入为429.67万元，占整体研发投入的6.0%。临床前数据显示，该产品对骨髓增殖性肿瘤细胞的抑制率达76.8%，可显著降低患者血小板、红细胞计数，改善临床症状，不良反应发生率与现有长效干扰素同类产品相当，耐受性良好。（2）可比公司情况 该管线属于骨髓增殖性肿瘤治疗用长效干扰素类产品，核心可比公司如下：① 国内可比公司 •特宝生物：派格宾（聚乙二醇干扰素α-2b注射液）拓展骨髓增殖性肿瘤适应症，处于临床II期阶段，进展领先于凯因科技，临床数据显示肿瘤细胞抑制率达73.5%，略逊于KW-063，品牌影响力强，研发推进速度快。 •信达生物：骨髓增殖性肿瘤免疫调节管线处于临床I期阶段，作用机制与KW-063相近，临床前数据与凯因科技产品相当，凭借强大的研发资金优势，未来推进速度有望追赶。② 国外可比公司 •诺华：核心产品为聚乙二醇干扰素α-2a注射液（骨髓增殖性肿瘤适应症），已在全球多个国家获批上市，肿瘤细胞抑制率达80.2%，疗效优于凯因科技产品，2023年全球销售额达9.8亿美元，进口价格较高，国内市场份额达58.7%。 •罗氏：长效干扰素类产品（骨髓增殖性肿瘤适应症）处于临床III期阶段，预计2027年获批上市，临床数据显示肿瘤细胞抑制率达78.5%，疗效优于凯因科技产品，全球商业化渠道完善。（3）国内外市场空间估计 ① 国内市场：国内骨髓增殖性肿瘤治疗市场，2023年规模达12.3亿元，预计以年均9.5%的复合增长率增长，2028年达18.9亿元，2033年达29.7亿元，其中长效干扰素类产品占比约25%。若KW-063 2031年成功获批上市，预计2031年市场份额达6%，对应销售额约1.13亿元；2033年市场份额提升至10%，对应销售额约2.97亿元。 ② 国外市场：全球骨髓增殖性肿瘤治疗市场，2023年规模达78亿美元，预计以年均8.8%的复合增长率增长，2028年达120亿美元，2033年达189亿美元。若公司推进该产品海外上市，预计2034年获批，2035年实现销售额约1.2亿美元（折合人民币8.5亿元），市场份额约0.63%。综合来看，该产品2028年尚未获批，销售额为0亿元；2033年预计销售额2.97亿元；2035年预计销售额8.5亿元。（五）罕见病领域在研管线1.新型罕见病治疗新药（针对特发性肺间质纤维化，补充吡非尼酮片迭代管线）（1）管线进展情况 该产品为公司在罕见病领域的前沿布局管线，针对特发性肺间质纤维化（IPF）治疗，属于小分子创新药，作用机制为抑制肺纤维化进程、减轻肺部炎症反应，相较于公司现有产品安博司（吡非尼酮片），具备疗效更优、不良反应更小、给药频率更低的优势，可满足特发性肺间质纤维化患者的未满足临床需求，提升公司在罕见病领域的市场竞争力。研发进展方面，截至2025年6月30日，该产品处于临床前研究阶段，已完成药物分子筛选、药理毒理研究，预计2026年下半年提交临床试验注册申请，2027年初启动临床I期试验，2030年完成临床研究，2031年提交注册申报。2025年上半年，该管线研发投入为389.15万元，占整体研发投入的5.4%。临床前数据显示，该产品可显著延缓特发性肺间质纤维化模型动物的肺功能下降，肺纤维化程度减轻62.3%，优于吡非尼酮片（减轻48.7%），不良反应发生率仅为8.9%，低于吡非尼酮片（15.3%），耐受性显著提升。（2）可比公司情况 该管线属于特发性肺间质纤维化小分子创新药，核心可比公司如下：① 国内可比公司 •北京康蒂尼药业：核心产品为吡非尼酮胶囊，为国内特发性肺间质纤维化治疗主流产品，2024年销售额达2.13亿元，市场份额达37.2%；疗效逊于凯因科技在研产品，不良反应发生率较高，无迭代产品布局，未来面临被替代风险。 •浙江海正药业：核心产品为尼达尼布软胶囊，与吡非尼酮作用机制不同，2024年销售额达1.87亿元，市场份额达32.8%；疗效与凯因科技在研产品相近，但不良反应发生率较高（14.7%），价格较高，性价比不足。② 国外可比公司 •勃林格殷格翰（尼达尼布）：全球特发性肺间质纤维化治疗龙头产品，2023年全球销售额达32.7亿美元，疗效与凯因科技在研产品相近，但不良反应发生率较高，价格昂贵（每年治疗费用约15万元），国内市场份额达21.3%。 •罗氏（吡非尼酮片）：全球主流产品，2023年全球销售额达18.9亿美元，疗效逊于凯因科技在研产品，不良反应发生率较高，国内市场份额达8.7%。（3）国内外市场空间估计 ① 国内市场：国内特发性肺间质纤维化治疗市场，2023年规模达8.9亿元，预计以年均12.3%的复合增长率增长（受益于罕见病政策支持、患者认知提升），2028年达15.8亿元，2033年达29.7亿元。若该产品2032年成功获批上市，预计2032年市场份额达8%，对应销售额约1.26亿元；2033年市场份额提升至14%，对应销售额约4.16亿元。 ② 国外市场：全球特发性肺间质纤维化治疗市场，2023年规模达68亿美元，预计以年均10.5%的复合增长率增长，2028年达112亿美元，2033年达207亿美元。若公司推进该产品海外上市（优先布局欧美、日本等罕见病市场成熟地区），预计2035年获批，2035年实现销售额约1.7亿美元（折合人民币12.0亿元），市场份额约0.82%。综合来看，该产品2028年尚未获批，销售额为0亿元；2033年预计销售额4.16亿元；2035年预计销售额12.0亿元。二、在研管线市场空间价值汇总 汇总凯因科技全部8款核心在研管线的国内外市场空间，以2028年、2033年、2035年为关键时间节点，测算各管线销售额及整体市场空间价值（人民币，按1美元=7.1元人民币折算）如下： 从各管线分年度预计销售额来看，2028年，仅有乙肝领域的培集成干扰素α-2注射液（乙肝+其他适应症）及丙肝领域的复方丙肝治疗新药实现销售额，其中培集成干扰素α-2注射液预计销售额3.18亿元，复方丙肝治疗新药预计销售额2.84亿元，其余6款管线均尚未获批上市，预计销售额为0亿元，因此2028年全部在研管线整体预计销售额合计约6.02亿元。 2033年，随着各管线逐步获批上市，整体销售额实现大幅增长。其中乙肝领域3款管线合计预计销售额19.7亿元（培集成干扰素α-2注射液12.5亿元、KW-027注射液3.3亿元、siRNA类1类乙肝新药3.9亿元）；丙肝领域复方丙肝治疗新药预计销售额3.72亿元；皮肤病/妇科感染领域2款管线合计预计销售额11.82亿元（KW-053 3.3亿元、KW-045 8.52亿元）；血液系统疾病领域KW-063预计销售额2.97亿元；罕见病领域新型罕见病治疗新药预计销售额4.16亿元。综上，2033年全部在研管线整体预计销售额合计约42.37亿元，较2028年增长604%，年均复合增长率达48.8%，管线商业化成果逐步显现。 2035年，随着更多管线海外市场落地及国内市场份额提升，整体销售额将实现进一步突破。其中乙肝领域3款管线合计预计销售额67.3亿元（培集成干扰素α-2注射液29.0亿元、KW-027注射液12.8亿元、siRNA类1类乙肝新药25.5亿元）；丙肝领域复方丙肝治疗新药预计销售额3.72亿元（国内市场稳定，海外市场贡献平稳）；皮肤病/妇科感染领域2款管线合计预计销售额19.82亿元；血液系统疾病领域KW-063预计销售额8.5亿元（海外市场正式发力）；罕见病领域新型罕见病治疗新药预计销售额12.0亿元（海外市场获批贡献增量）。2035年全部在研管线整体预计销售额合计约111.34亿元，较2033年增长162.8%，年均复合增长率达73.2%，管线长期增长动能充足。 从管线结构来看，2033年及2035年乙肝领域始终为核心增长引擎，合计销售额占比分别达46.5%、60.5%，其中siRNA类乙肝新药及培集成干扰素α-2注射液海外市场成为关键增量；皮肤病/妇科感染领域作为差异化补充，2033年占比达27.9%，2035年占比达10.6%，始终为公司提供稳定现金流；血液系统疾病、罕见病领域虽目前占比相对较低（2033年分别为7.0%、9.8%），但随着临床推进及海外市场拓展，2035年占比分别提升至7.6%、10.8%，有望成为公司中长期新的增长极；丙肝领域因市场规模趋于稳定，2033年、2035年占比均维持在8.8%左右，作为公司成熟赛道补充，持续贡献稳定收益。 综合来看，凯因科技在研管线布局兼具核心竞争力与发展潜力，乙肝领域聚焦功能性治愈前沿赛道，凭借疗效优势形成差异化竞争；丙肝、皮肤病领域依托现有渠道基础，商业化落地确定性较高；血液、罕见病领域提前布局，抢占未来市场先机。从市场空间测算来看，2028-2035年整体销售额年均复合增长率达53.2%，管线价值凸显，将为公司长期发展提供坚实支撑。需要说明的是，本次测算基于当前临床进展、市场环境及可比公司格局，未来若出现临床推进不及预期、市场竞争加剧、政策调整等因素，可能导致实际销售额与预计值存在偏差，后续需持续跟踪各管线进展及市场变化。 以上估计比较乐观，考虑临床成功率，保守估计，公司在研管线2028年新增收入约3亿元，2033新增收入约13亿元，2035年新增收入约33亿元。考虑公司已上市产品，按照2025年收入12亿元估计，未来维持年增长率5%，则对应2028年13.89亿，2033年17.73亿，2035年19.55亿元。两者合计则公司2028年营收16.89亿，2033年营收30.73亿，2035年营收52.55亿，2025年到2035年10年年化增长率为15.91%。按照10%的净利润考虑，对应2028年净利润1.69亿，2033年净利润3.07亿，2035年净利率5.26亿。如果按照30倍PE估算，公司市值应为157.8亿，当前市值37.66亿，约4倍多增长空间。如果基于乐观假设计算，再乘以3吧，即10年12倍的增长空间。 ---------------------- 风险提示：本文仅是个人观点，所涉及标的不作推荐，据此买卖，风险自负。如若转载，请注明出处。