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NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2025. “Johnson & Johnson delivered another strong performance in the third quarter fueled by the depth and strength of our portfolio and significant progress across our pipeline,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “With a sharpened focus on the six priority areas of Oncology, Immunology, Neuroscience, Cardiovascular, Surgery and Vision, Johnson & Johnson is in a new era of accelerated growth and innovation, with pioneering treatments that will continue to transform lives.” Overall financial results Q3 ($ in Millions, except EPS) 2025 2024 % Change Reported Sales $23,993 $22,471 6.8% Net Earnings $5,152 $2,694 91.2% EPS (diluted) $2.12 $1.11 91.0% Q3 Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change Operational Sales1,2 5.4% Adjusted Operational Sales1,3 4.4% Adjusted Net Earnings1,4 $6,801 $5,876 15.7% Adjusted EPS (diluted)1,4 $2.80 $2.42 15.7% Free Cash Flow6,7 ~$14,200 $14,471 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Third-quarter YTD 2025 is estimated as of October 14, 2025 Regional sales results Q3 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,708 $12,909 6.2% 6.2 - 4.4 International 10,285 9,562 7.6 4.4 3.2 4.4 Worldwide $23,993 $22,471 6.8% 5.4 1.4 4.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Segment sales results Q3 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $15,563 $14,580 6.8% 5.3 1.5 3.7 MedTech 8,430 7,891 6.8 5.6 1.2 5.7 Worldwide $23,993 $22,471 6.8% 5.4 1.4 4.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Third-Quarter 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 5.3%*, with net acquisitions and divestitures positively impacting growth by 1.6% due to CAPLYTA. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,070) basis points impact from STELARA in Immunology, as well as IMBRUVICA in Oncology. MedTech MedTech worldwide operational sales grew 5.6%*, with net acquisitions and divestitures negatively impacting growth by 0.1%. Growth was primarily driven by electrophysiology products, Abiomed and Shockwave in Cardiovascular, wound closure products in General Surgery, as well as Surgical Vision. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) October 2025 July 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 3.5% – 4.0% / 3.8% 3.2% – 3.7% / 3.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $93.0B – $93.4B / $93.2B 4.8% – 5.3% / 5.1% $92.7B – $93.1B / $92.9B 4.5% – 5.0% / 4.8% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $93.5B – $93.9B / $93.7B 5.4% – 5.9% / 5.7% $93.2B – $93.6B / $93.4B 5.1% – 5.6% / 5.4% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% 1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: Oct 2025 = $1.13 and July 2025 = $1.13 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine Other modeling considerations will be provided on the webcast. Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News, as well as Innovative Medicine Newsroom, MedTech News & Events, and www.factsabouttalc.com. Regulatory U.S. FDA approves TREMFYA (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor1 Press Release TREMFYA (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen Press Release Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG) Press Release Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis Press Release European Commission approves DARZALEX (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma Press Release European Commission approves IMBRUVICA (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant Press Release Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis Press Release Data Releases Johnson & Johnson to highlight breadth of its major depressive disorder portfolio at 2025 ECNP Congress1 Press Release Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill1 Press Release TREMFYA (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis1 Press Release Johnson & Johnson Unveils New Data Demonstrating Superior Clarity of Vision and Comfort of ACUVUE OASYS MAX 1-Day for ASTIGMATISM, and MULTIFOCAL for ASTIGMATISM Contact Lenses1 Press Release Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR Press Release TECVAYLI plus DARZALEX FASPRO treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma Press Release Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis Press Release Johnson & Johnson to showcase industry-leading neuropsychiatry innovations at the 2025 Psych Congress Annual Meeting Press Release Data published in The New England Journal of Medicine demonstrate RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer Press Release RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer Press Release New real-world data elevating patient perspectives highlight the need for scientific advancement in maternal fetal immunology at ISUOG 2025 Press Release Johnson & Johnson Unveils Results from the VARIPURE Substudy of SECURE, a Real-World Study on VARIPULSE Platform, at 2025 European Society of Cardiology (ESC) Congress Press Release New Data from the DanGer Shock Randomized Control Trial, Published in The New England Journal of Medicine, Confirms the Long-Term Survival Benefit of the Impella CP Heart Pump Press Release Johnson & Johnson showcases latest advancements in Alzheimer's research at AAIC 2025 Press Release Product Launch U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated Press Release Johnson & Johnson Launches VIRTUGUIDE AI-Powered Patient-Matched Lapidus System in U.S. to Reduce Complexity in Bunion Surgery for Millions Press Release Other Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors Press Release 1 Subsequent to the quarter Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations. About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com. Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results. Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results. Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. THIRD QUARTER NINE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 9,402 8,871 6.0 % 6.0 - $ 26,655 24,993 6.7 % 6.7 - 6,161 5,709 7.9 4.3 3.6 17,983 17,639 1.9 1.3 0.6 15,563 14,580 6.8 5.3 1.5 44,638 42,632 4.7 4.5 0.2 4,306 4,038 6.6 6.6 - 12,902 12,105 6.6 6.6 - 4,124 3,853 7.0 4.5 2.5 12,089 11,564 4.5 3.9 0.6 8,430 7,891 6.8 5.6 1.2 24,991 23,669 5.6 5.3 0.3 13,708 12,909 6.2 6.2 - 39,557 37,098 6.6 6.6 - 10,285 9,562 7.6 4.4 3.2 30,072 29,203 3.0 2.3 0.7 $ 23,993 22,471 6.8 % 5.4 1.4 $ 69,629 66,301 5.0 % 4.7 0.3 THIRD QUARTER NINE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 13,708 12,909 6.2 % 6.2 - $ 39,557 37,098 6.6 % 6.6 - 5,440 4,914 10.7 4.4 6.3 15,937 15,291 4.2 1.5 2.7 1,231 1,173 4.9 7.3 (2.4 ) 3,604 3,579 0.7 7.6 (6.9 ) 3,614 3,475 4.0 3.4 0.6 10,531 10,333 1.9 1.8 0.1 10,285 9,562 7.6 4.4 3.2 30,072 29,203 3.0 2.3 0.7 $ 23,993 22,471 6.8 % 5.4 1.4 $ 69,629 66,301 5.0 % 4.7 0.3 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 23,993 100.0 $ 22,471 100.0 6.8 7,303 30.4 6,963 31.0 4.9 16,690 69.6 15,508 69.0 7.6 5,922 24.7 5,478 24.3 8.1 3,672 15.3 4,952 22.0 (25.8 ) 18 0.1 (99 ) (0.4 ) (478 ) (2.0 ) 1,798 8.0 63 0.3 41 0.2 7,493 31.2 3,338 14.9 124.5 2,341 9.7 644 2.9 263.5 $ 5,152 21.5 $ 2,694 12.0 91.2 $ 2.12 $ 1.11 91.0 2,428.6 2,427.9 31.2 % 19.3 % $ 8,436 35.2 $ 7,277 32.4 15.9 $ 6,801 28.3 $ 5,876 26.1 15.7 $ 2.80 $ 2.42 15.7 19.4 % 19.3 % 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 69,629 100.0 $ 66,301 100.0 5.0 22,288 32.0 20,343 30.7 9.6 47,341 68.0 45,958 69.3 3.0 16,923 24.3 16,416 24.8 3.1 10,413 15.0 11,934 18.0 (12.7 ) - - 194 0.3 (62 ) (0.1 ) (433 ) (0.7 ) (7,692 ) (11.1 ) 4,855 7.3 144 0.2 192 0.3 27,615 39.7 12,800 19.3 115.7 5,927 8.6 2,165 3.3 173.8 $ 21,688 31.1 $ 10,635 16.0 103.9 $ 8.94 $ 4.38 104.1 2,424.8 2,429.5 21.5 % 16.9 % $ 24,635 35.4 $ 23,558 35.5 4.6 $ 20,206 29.0 $ 19,296 29.1 4.7 $ 8.33 $ 7.94 4.9 18.0 % 18.1 % Third Quarter Nine Months Ended 2025 2024 2025 2024 $5,152 $2,694 $21,688 $10,635 15 2,388 (6,894 ) 5,466 1,048 1,171 3,435 3,355 - 4 - 77 168 47 302 207 - 38 - 157 97 328 475 928 (387 ) (37 ) (327 ) 374 - - - 194 2 - 29 - (168 ) (762 ) 826 (2,055 ) 874 5 672 (42 ) $6,801 $5,876 $20,206 $19,296 2,428.6 2,427.9 2,424.8 2,429.5 $2.80 $2.42 $8.33 $7.94 $2.72 $8.24 1 2 6.8% 6.8% 6.8% 6.0% 6.6% 6.2% 7.9% 7.0% 7.6% 1.5 1.2 1.4 - - - 3.6 2.5 3.2 5.3% 5.6% 5.4% 6.0% 6.6% 6.2% 4.3% 4.5% 4.4% (1.6) (1.1) (2.7) (1.9) 0.0 0.0 0.0 0.1 0.1 0.0 0.2 0.1 0.0 0.1 0.0 3.7% 5.7% 4.4% 3.3% 6.8% 4.4% 4.3% 4.6% 4.4% 4.7% 5.6% 5.0% 6.7% 6.6% 6.6% 1.9% 4.5% 3.0% 0.2 0.3 0.3 - - - 0.6 0.6 0.7 4.5% 5.3% 4.7% 6.7% 6.6% 6.6% 1.3% 3.9% 2.3% (1.9) (0.6) (2.9) (0.9) (0.8) (0.2) (1.1) (0.7) (1.8) (1.2) 0.0 0.0 0.0 0.3 0.1 0.0 0.4 0.1 0.1 0.2 0.1 3.4% 3.7% 3.5% 4.9% 4.1% 4.6% 1.4% 3.3% 2.2% REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 3,468 2,816 23.2 % 23.2 % - $ 9,866 7,835 25.9 % 25.9 % - 3,060 2,565 19.3 % 14.8 % 4.5 % 8,652 7,450 16.1 % 15.0 % 1.1 % 6,529 5,380 21.3 % 19.2 % 2.1 % 18,519 15,284 21.2 % 20.6 % 0.6 % 396 258 53.3 % 53.3 % - 1,072 565 89.6 % 89.6 % - 128 27 * * * 260 63 * * * 524 286 83.5 % 81.4 % 2.1 % 1,332 629 * * * 2,088 1,684 24.0 % 24.0 % - 5,934 4,789 23.9 % 23.9 % - 1,584 1,332 18.9 % 14.7 % 4.2 % 4,514 3,797 18.9 % 17.9 % 1.0 % 3,672 3,016 21.7 % 19.9 % 1.8 % 10,448 8,586 21.7 % 21.3 % 0.4 % 378 337 12.3 % 12.3 % - 1,048 940 11.5 % 11.5 % - 558 453 23.0 % 17.6 % 5.4 % 1,567 1,275 22.9 % 21.1 % 1.8 % 936 790 18.4 % 15.3 % 3.1 % 2,615 2,215 18.0 % 17.0 % 1.0 % 211 259 (18.3 )% (18.3 )% - 685 770 (11.0 )% (11.0 )% - 483 494 (2.3 )% (6.6 )% 4.3 % 1,453 1,537 (5.4 )% (6.4 )% 1.0 % 695 753 (7.8 )% (10.6 )% 2.8 % 2,139 2,307 (7.3 )% (7.9 )% 0.6 % 136 68 99.7 % 99.7 % - 388 156 * * - 61 21 * * * 130 49 * * * 198 89 * * * 518 205 * * * 85 64 34.2 % 34.2 % - 235 173 35.8 % 35.8 % - 37 12 * * * 79 29 * * * 122 75 60.8 % 59.1 % 1.7 % 314 202 55.3 % 54.9 % 0.4 % 115 105 9.3 % 9.3 % - 334 310 7.5 % 7.5 % - 62 30 * * * 160 93 73.0 % 72.6 % 0.4 % 177 135 31.3 % 29.9 % 1.4 % 494 403 22.6 % 22.5 % 0.1 % 5 5 (25.0 )% (25.0 )% - 18 25 (30.4 )% (30.4 )% - 108 144 (25.1 )% (26.8 )% 1.7 % 365 470 (22.3 )% (23.0 )% 0.7 % 113 150 (25.1 )% (26.8 )% 1.7 % 383 496 (22.8 )% (23.4 )% 0.6 % 56 36 54.6 % 54.6 % - 153 106 44.8 % 44.8 % - 39 50 (22.2 )% (25.6 )% 3.4 % 123 136 (9.7 )% (10.6 )% 0.9 % 94 86 9.7 % 7.7 % 2.0 % 276 242 14.0 % 13.6 % 0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 2,676 3,068 (12.8 )% (12.8 )% - $ 7,377 8,499 (13.2 )% (13.2 )% - 1,493 1,552 (3.9 )% (6.3 )% 2.4 % 4,492 5,090 (11.8 )% (11.5 )% (0.3 )% 4,168 4,621 (9.8 )% (10.6 )% 0.8 % 11,868 13,590 (12.7 )% (12.6 )% (0.1 )% 326 281 16.2 % 16.2 % - 923 778 18.7 % 18.7 % - 19 27 (30.9 )% (30.9 )% - 63 89 (29.6 )% (29.6 )% - 132 112 17.7 % 16.7 % 1.0 % 413 380 8.6 % 10.4 % (1.8 )% 476 419 13.6 % 13.3 % 0.3 % 1,398 1,246 12.2 % 12.7 % (0.5 )% 309 299 3.6 % 3.6 % - 906 820 10.5 % 10.5 % - 377 218 73.0 % 69.8 % 3.2 % 1,130 787 43.5 % 44.6 % (1.1 )% 687 516 32.9 % 31.5 % 1.4 % 2,036 1,607 26.7 % 27.2 % (0.5 )% 1,022 1,770 (42.3 )% (42.3 )% - 3,081 5,021 (38.6 )% (38.6 )% - 549 906 (39.4 )% (41.4 )% 2.0 % 1,768 2,991 (40.9 )% (40.8 )% (0.1 )% 1,570 2,676 (41.3 )% (42.0 )% 0.7 % 4,848 8,012 (39.5 )% (39.5 )% 0.0 % 989 691 43.1 % 43.1 % - 2,384 1,789 33.3 % 33.3 % - 434 316 37.4 % 33.4 % 4.0 % 1,181 932 26.7 % 26.1 % 0.6 % 1,424 1,007 41.3 % 40.1 % 1.2 % 3,566 2,721 31.0 % 30.8 % 0.2 % 12 1 * * - 21 3 * * - 0 0 - - - 0 0 - - - 12 1 * * - 21 3 * * - 1,367 1,094 25.0 % 25.0 % - 3,712 3,250 14.2 % 14.2 % - 658 662 (0.7 )% (2.6 )% 1.9 % 2,011 2,090 (3.8 )% (3.7 )% (0.1 )% 2,024 1,755 15.3 % 14.6 % 0.7 % 5,722 5,340 7.2 % 7.2 % 0.0 % 240 - * * - 451 - * * - - - - - - - - - - - 240 - * * - 451 - * * - 14 26 (49.2 )% (49.2 )% - 76 101 (24.9 )% (24.9 )% - 127 117 9.0 % 8.5 % 0.5 % 376 382 (1.4 )% (0.4 )% (1.0 )% 140 142 (1.4 )% (1.8 )% 0.4 % 452 482 (6.3 )% (5.5 )% (0.8 )% 664 780 (14.9 )% (14.9 )% - 2,021 2,329 (13.2 )% (13.2 )% - 267 269 (0.9 )% (3.0 )% 2.1 % 804 830 (3.1 )% (3.0 )% (0.1 )% 929 1,049 (11.3 )% (11.9 )% 0.6 % 2,824 3,159 (10.6 )% (10.5 )% (0.1 )% 405 243 67.1 % 67.1 % - 1,047 660 58.7 % 58.7 % - 53 42 28.9 % 23.8 % 5.1 % 146 120 21.9 % 21.4 % 0.5 % 459 284 61.5 % 60.8 % 0.7 % 1,193 780 53.0 % 52.9 % 0.1 % 46 46 0.4 % 0.4 % - 119 161 (26.4 )% (26.4 )% - 210 235 (10.7 )% (12.3 )% 1.6 % 684 759 (9.8 )% (9.9 )% 0.1 % 256 281 (8.9 )% (10.2 )% 1.3 % 803 920 (12.7 )% (12.8 )% 0.1 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 815 815 (0.1 )% (0.1 )% - $ 2,358 2,324 1.5 % 1.5 % - 300 287 4.8 % 2.0 % 2.8 % 895 866 3.4 % 2.6 % 0.8 % 1,115 1,102 1.1 % 0.4 % 0.7 % 3,253 3,190 2.0 % 1.8 % 0.2 % 409 417 (1.6 )% (1.6 )% - 1,175 1,149 2.3 % 2.3 % - 168 166 1.1 % (1.8 )% 2.9 % 507 506 0.2 % (0.7 )% 0.9 % 578 583 (0.8 )% (1.7 )% 0.9 % 1,682 1,655 1.7 % 1.4 % 0.3 % 392 379 3.5 % 3.5 % - 1,139 1,120 1.7 % 1.7 % - 92 80 15.2 % 12.0 % 3.2 % 272 232 17.0 % 16.4 % 0.6 % 484 458 5.6 % 5.0 % 0.6 % 1,411 1,352 4.3 % 4.2 % 0.1 % 13 21 (36.5 )% (36.5 )% - 44 56 (21.5 )% (21.5 )% - 39 39 (1.0 )% (2.5 )% 1.5 % 116 127 (8.9 )% (9.1 )% 0.2 % 53 60 (13.1 )% (14.1 )% 1.0 % 160 183 (12.7 )% (12.9 )% 0.2 % 326 365 (10.5 )% (10.5 )% - 961 1,023 (6.0 )% (6.0 )% - 501 471 6.4 % 0.5 % 5.9 % 1,472 1,599 (7.9 )% (9.8 )% 1.9 % 829 836 (0.9 )% (4.3 )% 3.4 % 2,434 2,622 (7.2 )% (8.3 )% 1.1 % 7 8 (7.9 )% (7.9 )% - 21 24 (11.8 )% (11.8 )% - 378 323 16.9 % 9.9 % 7.0 % 1,082 926 16.8 % 13.6 % 3.2 % 385 330 16.4 % 9.5 % 6.9 % 1,103 950 16.1 % 13.0 % 3.1 % 315 355 (11.0 )% (11.0 )% - 932 990 (5.8 )% (5.8 )% - 81 94 (13.6 )% (18.5 )% 4.9 % 264 315 (16.1 )% (16.6 )% 0.5 % 397 449 (11.6 )% (12.6 )% 1.0 % 1,196 1,305 (8.3 )% (8.4 )% 0.1 % 4 3 57.3 % 57.3 % - 8 10 (11.0 )% (11.0 )% - 42 54 (21.2 )% (22.3 )% 1.1 % 126 358 (64.7 )% (64.6 )% (0.1 )% 47 56 (17.5 )% (18.5 )% 1.0 % 135 367 (63.3 )% (63.2 )% (0.1 )% 750 713 5.3 % 5.3 % - 2,381 2,061 15.5 % 15.5 % - 149 170 (13.1 )% (15.6 )% 2.5 % 461 543 (15.2 )% (14.7 )% (0.5 )% 899 884 1.7 % 1.2 % 0.5 % 2,842 2,605 9.1 % 9.2 % (0.1 )% 635 592 7.4 % 7.4 % - 1,946 1,697 14.7 % 14.7 % - - - - - - - - - - - 635 592 7.4 % 7.4 % - 1,946 1,697 14.7 % 14.7 % - 115 121 (5.2 )% (5.2 )% - 435 364 19.4 % 19.4 % - 149 170 (13.1 )% (15.6 )% 2.5 % 461 543 (15.2 )% (14.7 )% (0.5 )% 264 292 (9.8 )% (11.3 )% 1.5 % 896 908 (1.3 )% (1.0 )% (0.3 )% 9,402 8,871 6.0 % 6.0 % - 26,655 24,993 6.7 % 6.7 % - 6,161 5,709 7.9 % 4.3 % 3.6 % 17,983 17,639 1.9 % 1.3 % 0.6 % $ 15,563 14,580 6.8 % 5.3 % 1.5 % $ 44,638 42,632 4.7 % 4.5 % 0.2 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,306 1,148 13.8 % 13.8 % - $ 3,931 3,292 19.4 % 19.4 % - 908 819 10.8 % 8.4 % 2.4 % 2,698 2,353 14.6 % 13.8 % 0.8 % 2,213 1,966 12.6 % 11.6 % 1.0 % 6,629 5,645 17.4 % 17.1 % 0.3 % 720 660 9.1 % 9.1 % - 2,145 2,057 4.3 % 4.3 % - 698 619 12.6 % 10.4 % 2.2 % 2,064 1,889 9.2 % 8.6 % 0.6 % 1,418 1,279 10.8 % 9.7 % 1.1 % 4,209 3,946 6.7 % 6.4 % 0.3 % 336 293 14.5 % 14.5 % - 1,035 905 14.3 % 14.3 % - 86 68 26.8 % 20.2 % 6.6 % 256 207 23.9 % 20.7 % 3.2 % 423 362 16.8 % 15.6 % 1.2 % 1,291 1,112 16.1 % 15.5 % 0.6 % 220 163 34.4 % 34.4 % - 659 240 * * - 59 66 (11.2 )% (12.4 )% 1.2 % 169 66 * * * 278 229 21.2 % 20.9 % 0.3 % 828 306 * * * 30 30 0.0 % 0.0 % - 93 89 4.2 % 4.2 % - 65 66 (1.0 )% (2.5 )% 1.5 % 209 192 9.0 % 8.7 % 0.3 % 95 96 (0.7 )% (1.7 )% 1.0 % 302 281 7.5 % 7.2 % 0.3 % 1,396 1,359 2.7 % 2.7 % - 4,200 4,229 (0.7 )% (0.7 )% - 878 832 5.6 % 1.9 % 3.7 % 2,620 2,614 0.3 % (1.1 )% 1.4 % 2,274 2,191 3.8 % 2.4 % 1.4 % 6,820 6,843 (0.3 )% (0.8 )% 0.5 % 262 250 4.7 % 4.7 % - 796 785 1.3 % 1.3 % - 144 131 9.7 % 5.9 % 3.8 % 440 435 1.2 % 0.0 % 1.2 % 405 381 6.4 % 5.1 % 1.3 % 1,235 1,220 1.3 % 0.9 % 0.4 % 216 212 2.1 % 2.1 % - 673 684 (1.5 )% (1.5 )% - 160 140 14.3 % 10.9 % 3.4 % 482 463 4.0 % 3.0 % 1.0 % 377 352 7.0 % 5.6 % 1.4 % 1,155 1,147 0.7 % 0.3 % 0.4 % 512 497 3.0 % 3.0 % - 1,515 1,499 1.1 % 1.1 % - 281 265 6.4 % 2.5 % 3.9 % 818 786 4.1 % 2.7 % 1.4 % 793 761 4.2 % 2.9 % 1.3 % 2,333 2,285 2.1 % 1.6 % 0.5 % 406 400 1.3 % 1.3 % - 1,216 1,262 (3.7 )% (3.7 )% - 293 296 (1.1 )% (4.8 )% 3.7 % 881 930 (5.3 )% (6.8 )% 1.5 % 698 696 0.3 % (1.3 )% 1.6 % 2,096 2,191 (4.3 )% (5.0 )% 0.7 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,031 983 4.9 % 4.9 % - $ 3,076 2,965 3.8 % 3.8 % - 1,511 1,451 4.1 % 2.2 % 1.9 % 4,417 4,373 1.0 % 0.9 % 0.1 % 2,542 2,434 4.4 % 3.3 % 1.1 % 7,493 7,338 2.1 % 2.1 % 0.0 % 477 448 6.2 % 6.2 % - 1,411 1,360 3.7 % 3.7 % - 688 661 4.2 % 2.1 % 2.1 % 1,991 1,977 0.7 % 0.5 % 0.2 % 1,165 1,109 5.0 % 3.8 % 1.2 % 3,402 3,337 1.9 % 1.8 % 0.1 % 555 535 3.8 % 3.8 % - 1,666 1,605 3.8 % 3.8 % - 823 791 4.0 % 2.2 % 1.8 % 2,426 2,397 1.2 % 1.3 % (0.1 )% 1,378 1,325 3.9 % 2.9 % 1.0 % 4,092 4,001 2.3 % 2.3 % 0.0 % 571 549 4.2 % 4.2 % - 1,694 1,619 4.7 % 4.7 % - 828 751 10.2 % 7.5 % 2.7 % 2,354 2,224 5.8 % 5.0 % 0.8 % 1,400 1,300 7.7 % 6.1 % 1.6 % 4,048 3,843 5.3 % 4.8 % 0.5 % 456 441 3.5 % 3.5 % - 1,337 1,288 3.8 % 3.8 % - 562 527 6.6 % 3.4 % 3.2 % 1,565 1,508 3.8 % 2.4 % 1.4 % 1,018 968 5.2 % 3.5 % 1.7 % 2,902 2,796 3.8 % 3.1 % 0.7 % 116 108 7.0 % 7.0 % - 358 331 8.0 % 8.0 % - 266 225 18.7 % 17.1 % 1.6 % 789 717 10.1 % 10.3 % (0.2 )% 383 333 14.9 % 13.8 % 1.1 % 1,147 1,048 9.4 % 9.6 % (0.2 )% 4,306 4,038 6.6 % 6.6 % - 12,902 12,105 6.6 % 6.6 % - 4,124 3,853 7.0 % 4.5 % 2.5 % 12,089 11,564 4.5 % 3.9 % 0.6 % $ 8,430 7,891 6.8 % 5.6 % 1.2 % $ 24,991 23,669 5.6 % 5.3 % 0.3 % GAAP to Non-GAAP Reconciliation $ in Millions Third Quarter Sept 28, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Third Quarter Sept 28, 2025 Non-GAAP $ 3,672 (568 ) (11 ) 3,093 2,869 2,869 2,944 2,944 (368 ) 5 (48 ) 174 (1 ) (238 ) 6,446 568 (5 ) - 59 (174 ) - 1 6,895 $ 3,612 (480 ) (12 ) (1 ) 3,119 2,801 2,801 728 728 2 5 (156 ) (48 ) 213 (1 ) 15 1,287 480 (5 ) 168 49 (213 ) - 1 1,767 $ 19 19 252 252 - - (31 ) (25 ) 11 (45 ) (240 ) - 25 - (11 ) - - - (226 ) $ 7,303 (1,048 ) (12 ) (12 ) 6,231 5,922 5,922 3,672 3,672 (478 ) (15 ) (93 ) (85 ) 387 (2 ) (286 ) - - 18 18 63 (63 ) - 7,493 1,048 15 168 97 (387 ) - 2 8,436 2,341 193 3 34 16 (87 ) (874 ) 9 1,635 5,152 855 12 134 81 (300 ) 874 (7 ) 6,801 GAAP to Non-GAAP Reconciliation $ in Millions $ 3,549 (695 ) (2 ) 2,852 2,491 2,491 4,213 (2 ) 4,211 (155 ) (356 ) (19 ) (6 ) 41 (495 ) 4,482 695 356 19 6 (41 ) - 4 - 5,521 $ 3,381 (476 ) (6 ) (156 ) (16 ) 2,727 2,723 (3 ) 2,720 739 (36 ) (19 ) 684 (11 ) (19 ) (22 ) (85 ) (4 ) (141 ) 1,059 476 19 28 277 4 38 - - 1,901 $ 33 33 264 264 - - 1,906 (2,013 ) (45 ) (152 ) (2,203 ) - 2,013 - 45 - - - - (145 ) $ 6,963 (1,171 ) (6 ) (156 ) (16 ) (2 ) 5,612 5,478 (3 ) 5,475 4,952 (36 ) (19 ) (2 ) 4,895 1,798 (2,388 ) (136 ) 37 (689 ) - - (99 ) (99 ) 41 (41 ) - 3,338 1,171 2,388 47 328 (37 ) 38 4 - 7,277 644 169 527 9 59 (9 ) 6 1 (5 ) 1,401 2,694 1,002 1,861 38 269 (28 ) 32 3 5 5,876 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 11,670 (2,002 ) (24 ) 9,644 7,919 7,919 8,361 8,361 (520 ) 74 (275 ) 164 (14 ) (571 ) 17,208 2,002 (74 ) - 299 (164 ) - 14 19,285 $ 10,576 (1,433 ) (35 ) (52 ) 9,056 8,319 8,319 2,052 37 2,089 132 (78 ) (267 ) (155 ) 163 (15 ) (220 ) 3,912 1,433 78 302 170 (163 ) - 15 5,747 $ 42 42 685 685 - - (7,222 ) 6,898 (6 ) (330 ) 6,495 - (6,898 ) - 6 - - - (397 ) $ 22,288 (3,435 ) (35 ) (76 ) 18,742 16,923 16,923 10,413 37 10,450 (7,692 ) 6,894 (123 ) (436 ) 327 (29 ) (1,059 ) - - (62 ) (62 ) 144 (144 ) - 27,615 3,435 (6,894 ) 302 475 (327 ) - 29 24,635 5,927 603 (1,541 ) 58 118 (73 ) (672 ) 9 4,429 21,688 2,832 (5,353 ) 244 357 (254 ) 672 20 20,206 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 10,522 (2,087 ) (8 ) 8,427 7,594 7,594 9,831 (19 ) 9,812 (225 ) (399 ) (194 ) (100 ) (54 ) 26 (50 ) (996 ) 14,910 2,087 399 194 100 54 (26 ) - 77 - 17,795 $ 9,749 (1,268 ) (15 ) (206 ) (66 ) 8,194 7,976 (12 ) 7,964 2,103 (69 ) (79 ) 1,955 173 (15 ) (92 ) (472 ) (48 ) (454 ) 3,668 1,268 15 - 107 747 48 157 - - 6,010 $ 72 72 846 846 - - 4,860 (5,052 ) (127 ) (352 ) (671 ) (5,778 ) - 5,052 - - 127 352 - - - (247 ) $ 20,343 (3,355 ) (15 ) (206 ) (66 ) (8 ) 16,693 16,416 (12 ) 16,404 11,934 (69 ) (79 ) (19 ) 11,767 4,855 (5,466 ) (653 ) (374 ) (50 ) (1,688 ) 194 (194 ) - (433 ) (433 ) 192 (192 ) - 12,800 3,355 5,466 194 207 928 374 157 77 - 23,558 2,165 473 1,224 43 42 222 5 29 17 42 4,262 10,635 2,882 4,242 151 165 706 369 128 60 (42 ) 19,296

点击蓝字 关注我们 本 期 看 点 重症肌无力（gMG）是一种以抗体介导的神经—肌肉接头功能障碍性疾病，全球约70万人受其影响，美国约10万人，每年新发病例中10–15%为12–17岁青少年。随着对全身型重症肌无力（gMG）发病机制的深入了解，补体C5抑制与FcRn阻断两大治疗通路成为行业焦点。本文将梳理几款C5抑制剂的最新进展，并与主要FcRn产品进行横向对比，助您全面把握gMG市场最新格局。 本期内容 01 阿斯利康丨C5补体抑制剂产品矩阵 02 FcRn的结构和功能及产品进展 03 总结与展望 【01 阿斯利康丨C5补体抑制剂产品矩阵】 2025年10月11日，优时比（UCB）宣布：泽卢克布仑钠（zilucoplan，商品名海外为 ZILBRYSQ）获国家药监局批准，在与常规治疗联合时用于AChR抗体阳性的成人全身型重症肌无力（gMG）。它是全球首个且唯一可皮下注射、自行给药的C5抑制剂，有望显著降低就医负担、提升依从性与生活质量。 重症肌无力是一种罕见的自身免疫性神经肌肉疾病，患者常出现言语、吞咽、呼吸和肢体肌力障碍，长期依赖静脉输注治疗。以往的C5抑制剂（如依库珠单抗、瑞利珠单抗）需定期前往医院输液，既耗时又增加感染风险。泽卢克布仑钠的出现，首次让患者可在经过培训后于家中完成注射，从而显著减轻就医负担，标志着重症肌无力从“院内管理”走向“居家管理”的新阶段。 Gefurulimab丨双特异性C5抗体 2025年7月24日，阿斯利康欣然宣布， 其自主研发的gefurulimab（ALXN1720）在PREVAIL III期试验中取得主要终点成功。gefurulimab为一款约25 kDa的双特异性纳米抗体，能够有效结合抗C5可变区与白蛋白结合片段，为皮下注射剂型，给药周期为每周一次； 数据显示，与安慰剂相比，gefurulimab在第26周时，在重症肌无力日常生活活动能力量表（MG-ADL）总分上显示出具有统计学显著性和临床意义的、相较于基线的改善。 后续计划向FDA、EMA及NMPA提交注册申请，预计2026年实现全球上市。 上述产品为2020年阿斯利康斥资约390亿美元，收购Alexion公司所得，Alexion作为C5补体抑制的先锋，既往已经推动2款C5补体抑制剂上市。 依库珠单抗（Soliris®，eculizumab） 依库珠单抗（Soliris®）是一种人源化IgG2/4κ单克隆抗体。在阵发性睡眠性血红蛋白尿(PNH）患者中，可持续防止溶血、减少输血需求；在非典型溶血尿毒综合征(aHUS)中，则有效预防微血管病变；在gMG和抗体阳性的成年患者的视神经脊髓炎症（NMOSD）等适应症中，也展现出良好疗效。 2007年3月，Soliris®获FDA批准用于PNH，开启C5抑制疗法新时代； 2018年，Soliris®在中国获批，用于PNH和非典型溶血性尿毒症综合征（aHUS）； 2023年6月13日，NMPA批准Soliris®（商品名舒立瑞）用于抗AChR抗体阳性成人全身型重症肌无力（gMG）； 2023年11月，通过国家医保谈判；2024年1月1日，新价格正式执行，按乙类医保70%报销计算，显著减轻了长期用药经济压力。 瑞利珠单抗（Ultomiris®，ravulizumab） 2025年4月22日，中国上海—— 长效C5补体抑制剂伟立瑞®（英文商品名：Ultomiris®，通用名：瑞利珠单抗注射液）在中国正式获批与常规治疗药物联合用于治疗抗乙酰胆碱受体（AChR）抗体阳性的成人全身型重症肌无力（gMG）患者。 与此同时，FcRn靶点也成为当代的热门赛道。 02 国内上市进度 FcRn（新生儿Fc受体）是一种“重复利用”IgG的运输通道，广泛分布于血管内皮、胎盘、肠道上皮和乳腺等处。  FcRn及其配体的结构  FcRn对IgG的转运保护机制 其简化作用机制如下： 捕获回收：血管内皮细胞会吞噬血液中的蛋白质，FcRn在细胞内的低pH环境下与IgG的Fc段紧密结合，避免IgG被送入溶酶体降解； 再循环：结合后的IgG被运回细胞表面，以中性pH释放回血液，从而延长了IgG在体内的半衰期； 阻断应用：在自身免疫病中，病理性IgG水平过高，通过抗体药物阻断FcRn–IgG结合，可加速这些自身抗体的清除（可下降45%–85%），同时不影响IgM、IgA和白蛋白；停药后IgG水平可在约60天内恢复。 这种有选择且可逆的清除机制，使FcRn成为治疗多种IgG介导自身免疫病的理想靶点。 国内产品上市进度 强生尼卡利单抗 •  2025年4月23日，CDE官网公示，强生尼卡利单抗注射液在中国申报上市，此前该药已被纳入优先审评，适用于治疗自身抗体阳性的全身型重症肌无力（gMG）成人患者和青少年患者（大于12岁）。 •  尼卡利单抗是强生通过约65亿美元收购Momenta Pharmaceuticals获得的在研FcRn抗体。2024年8月，该药已在美国申报上市，用于重症肌无力。 优时比罗泽利昔单抗 •  2025年3月31日，药监局官网显示，优时比FcRn单抗罗泽利昔单抗注射液获批上市。根据公开资料及既往临床研究，Insight数据库推测该适应症为重症肌无力（gMG）。 巴托利单抗 •  和铂医药与石药集团引进的巴托利单抗也已于2024年7月申报上市并获受理。但海外合作公司却放弃了这个产品。 在全球FcRn靶点竞争上，强生、优时比等企业已经在技术迭代。而Immunovant暂不提交巴托利单抗上市申请的决定，凸显了FcRn抑制剂赛道的激烈竞争，也揭示了跨国药企与本土玩家在全球权益布局中的深层博弈。 03 总结与展望 从Soliris®的首次批准到Ultomiris®的长效创新，再到今日gefurulimab的双抗重大突破，AZ在C5补体抑制领域持续自我革新，构建了多层次给药方案，满足不同患者需求。下一步，结合FcRn阻断、大分子靶向及数字化患者支持，将进一步加速gMG的综合管理时代。 ★