Icotrokinra

2025 Fourth-Quarter reported sales growth of 9.1% to $24.6 Billion with operational growth of 7.1%* and adjusted operational growth of 6.1%*; 2025 Fourth-Quarter earnings per share (EPS) of $2.10 and adjusted EPS of $2.46, both include $(0.10) due to the acquisition of Halda Therapeutics 2025 Full-Year reported sales growth of 6.0% to $94.2 Billion with operational growth of 5.3%* and adjusted operational growth of 4.2%*; 2025 Full-Year earnings per share (EPS) of $11.03 and adjusted EPS of $10.79, both include $(0.10) due to the acquisition of Halda Therapeutics Significant innovation including approvals of CAPLYTA for major depressive disorder and RYBREVANT FASPRO plus LAZCLUZE for non-small cell lung cancer, landmark data for TECVAYLI plus DARZALEX FASPRO as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma, the acquisition of Halda Therapeutics, and submission of OTTAVA Robotic Surgical System Company issues guidance for 2026 with estimated reported sales of $100.5 Billion or 6.7% at the midpoint, and adjusted EPS 4 of $11.53 or 6.9% at the midpoint NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full-year 2025. “2025 was a catapult year for Johnson & Johnson, fueled by the strongest portfolio and pipeline in our history,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “Last year kicked off a new era of accelerated growth, driven by medical innovation that is transforming lives in our six key businesses: Oncology, Immunology, Neuroscience, Cardiovascular, Surgery, and Vision. In each of these important areas, our leadership is expanding driven by game-changing science and technology.” Overall financial results Q4 Full Year ($ in Millions, except EPS) 2025 2024 % Change 2025 2024 % Change Reported Sales $24,564 $22,520 9.1% $94,193 $88,821 6.0% Net Earnings $5,116 $3,431 49.1% $26,804 $14,066 90.6% EPS (diluted) $2.10 $1.41 48.9% $11.03 $5.79 90.5% Q4 Full Year Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change 2025 2024 % Change Operational Sales 1,2 7.1% 5.3% Adjusted Operational Sales 1,3 6.1% 4.2% Adjusted Net Earnings 1,4 $6,009 $4,946 21.5% $26,215 $24,242 8.1% Adjusted EPS (diluted) 1,4 $2.46 $2.04 20.6% $10.79 $9.98 8.1% Free Cash Flow 5,6 ~$19,700 $19,842 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 6 Full year 2025 is estimated as of January 21, 2026. Note: values may have been rounded Regional sales results Q4 % Change ($ in Millions) 2025 2024 Reported Operational 1,2 Currency Adjusted Operational 1,3 U.S. $14,195 $13,204 7.5% 7.5 - 5.7 International 10,369 9,316 11.3 6.6 4.7 6.8 Worldwide $24,564 $22,520 9.1% 7.1 2.0 6.1 Full Year % Change ($ in Millions) 2025 2024 Reported Operational 1,2 Currency Adjusted Operational 1,3 U.S. $53,752 $50,302 6.9% 6.9 - 4.9 International 40,441 38,519 5.0 3.4 1.6 3.3 Worldwide $94,193 $88,821 6.0% 5.3 0.7 4.2 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Segment sales results Q4 % Change ($ in Millions) 2025 2024 Reported Operational 1,2 Currency Adjusted Operational 1,3 Innovative Medicine $15,763 $14,332 10.0% 7.9 2.1 6.2 MedTech 8,801 8,188 7.5 5.8 1.7 5.9 Worldwide $24,564 $22,520 9.1% 7.1 2.0 6.1 Full Year % Change ($ in Millions) 2025 2024 Reported Operational 1,2 Currency Adjusted Operational 1,3 Innovative Medicine $60,401 $56,964 6.0% 5.3 0.7 4.1 MedTech 33,792 31,857 6.1 5.4 0.7 4.3 Worldwide $94,193 $88,821 6.0% 5.3 0.7 4.2 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Full-year 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 5.3%*, with net acquisitions and divestitures positively impacting growth by 1.2% primarily due to CAPLYTA. Growth was driven primarily by DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,040) basis points impact from STELARA in Immunology. MedTech MedTech worldwide operational sales grew 5.4%*, with net acquisitions and divestitures positively impacting growth by 1.1% primarily due to Shockwave. Growth was driven primarily by electrophysiology products and Abiomed in Cardiovascular and wound closure products in General Surgery. Full-year 2026 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) January 2026 Adjusted Operational Sales 1,2 Change vs. Prior Year / Mid-point 5.4% – 6.4% / 5.9% Operational Sales 2 / Mid-point Change vs. Prior Year / Mid-point $99.5B – $100.5B / $100.0B 5.7% – 6.7% / 6.2% Estimated Reported Sales 3 / Mid-point Change vs. Prior Year / Mid-point $100.0B – $101.0B / $100.5B 6.2% – 7.2% / 6.7% Adjusted Operational EPS (Diluted) 2,4 / Mid-point Change vs. Prior Year / Mid-point $11.28 – $11.48 / $11.38 4.5% – 6.5% / 5.5% Adjusted EPS (Diluted) 3,4 / Mid-point Change vs. Prior Year / Mid-point $11.43 – $11.63 / $11.53 5.9% – 7.9% / 6.9% 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: January 2026 = $1.17 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items Note: percentages may have been rounded 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 , 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 . Regulatory Johnson & Johnson Submits OTTAVA Robotic Surgical System to the U.S. Food and Drug Administration 1 Press Release Johnson & Johnson Receives FDA Approval for TRUFILL n‑BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma Press Release U.S. FDA Approval of RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when Combined with LAZCLUZE (lazertinib) Press Release U.S. FDA approves AKEEGA as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care Press Release DARZALEX FASPRO is the first and only treatment approved by the U.S. FDA for patients with high-risk smoldering multiple myeloma Press Release FDA approval of CAPLYTA (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder Press Release Data Releases New clinical data highlights CAPLYTA (lumateperone) as a promising option for achieving remission in adults with major depressive disorder 1 Press Release TECVAYLI monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide 1 Press Release RYBREVANT (amivantamab-vmjw) longer-term results show promising and durable responses in difficult-to-treat colorectal cancer 1 Press Release Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study 1 Press Release Unprecedented results from the Phase 3 MajesTEC-3 study support TECVAYLI plus DARZALEX FASPRO as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma Press Release Earlier use of CARVYKTI demonstrated lasting treatment-free remissions at 2.5 years in patients with relapsed or refractory multiple myeloma Press Release Johnson & Johnson's INLEXZO (gemcitabine intravesical system) delivers 74 percent disease-free survival at one year in BCG-unresponsive, high-risk, papillary-only NMIBC Press Release New long-term data reinforces TREMFYA (guselkumab) as the only IL-23 inhibitor proven to substantially inhibit structural joint damage in active psoriatic arthritis Press Release Johnson & Johnson announces first head-to-head study comparing IMAAVY with an alternative FcRn blocker in generalized myasthenia gravis (gMG) at AANEM Annual Meeting Press Release Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety pro once-daily pill through 28 weeks in ulcerative colitis Press Release TREMFYA (guselkumab), the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn's disease at two years Press Release Published in The Lancet: Nipocalimab significantly decreased Sjögren's disease (SjD) activity and severity through substantial reduction in Sjögren's-related autoantibodies Press Release Icotrokinra long-term results affirm promise of targeted oral peptide with high rates of durable skin clearance and favorable safety pro difficult-to-treat scalp and genital psoriasis Press Release Subcutaneous amivantamab delivers promising 45 percent overall response rate with median duration of 7.2 months in recurrent or metastatic head and neck cancer Press Release TECVAYLI plus DARZALEX FASPRO combination regimen significantly improves progression-free survival and overall survival versus standard of care Press Release Other Johnson & Johnson Reaches Agreement with U.S. Government to Improve Access to Medicines and Lower Costs for Millions of Americans; Delivers on U.S. Manufacturing and Innovation Investments 1 Press Release Johnson & Johnson completes acquisition of Halda Therapeutics and its novel platform to revolutionize cancer treatment and enable next-generation oral therapies Press Release Johnson & Johnson Announces Intent to Separate Its Orthopaedics Business 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 . 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 , , 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. Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) FOURTH QUARTER TWELVE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency Sales to customers by segment of business Innovative Medicine U.S. $ 9,689 8,977 7.9 % 7.9 - $ 36,344 33,970 7.0 % 7.0 - International 6,074 5,355 13.4 7.9 5.5 24,057 22,994 4.6 2.9 1.7 15,763 14,332 10.0 7.9 2.1 60,401 56,964 6.0 5.3 0.7 MedTech U.S. 4,506 4,227 6.6 6.6 - 17,408 16,332 6.6 6.6 - International 4,295 3,961 8.5 4.9 3.6 16,384 15,525 5.5 4.1 1.4 8,801 8,188 7.5 5.8 1.7 33,792 31,857 6.1 5.4 0.7 U.S. 14,195 13,204 7.5 7.5 - 53,752 50,302 6.9 6.9 - International 10,369 9,316 11.3 6.6 4.7 40,441 38,519 5.0 3.4 1.6 Worldwide $ 24,564 22,520 9.1 % 7.1 2.0 $ 94,193 88,821 6.0 % 5.3 0.7 Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) FOURTH QUARTER TWELVE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency Sales to customers by geographic area U.S. $ 14,195 13,204 7.5 % 7.5 - $ 53,752 50,302 6.9 % 6.9 - Europe 5,598 4,921 13.8 5.2 8.6 21,535 20,212 6.5 2.4 4.1 Western Hemisphere excluding U.S. 1,271 1,135 12.0 11.0 1.0 4,875 4,714 3.4 8.4 (5.0 ) Asia-Pacific, Africa 3,500 3,260 7.4 7.2 0.2 14,031 13,593 3.2 3.1 0.1 International 10,369 9,316 11.3 6.6 4.7 40,441 38,519 5.0 3.4 1.6 Worldwide $ 24,564 22,520 9.1 % 7.1 2.0 $ 94,193 88,821 6.0 % 5.3 0.7 Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) FOURTH QUARTER 2025 2024 Percent Increase (Decrease) Amount Percent to Sales Amount Percent to Sales Sales to customers $ 24,564 100.0 $ 22,520 100.0 9.1 Cost of products sold 7,968 32.4 7,128 31.6 11.8 Gross Profit 16,596 67.6 15,392 68.4 7.8 Selling, marketing and administrative expenses 6,753 27.5 6,453 28.6 4.6 Research and development expense 4,252 17.3 5,298 23.5 (19.7 ) In-process research and development impairments 81 0.3 17 0.1 Interest (income) expense, net (23 ) (0.1 ) (144 ) (0.6 ) Other (income) expense, net 483 2.0 (161 ) (0.7 ) Restructuring 84 0.4 42 0.2 Earnings before provision for taxes on income 4,966 20.2 3,887 17.3 27.8 (Benefit from)/Provision for taxes on income (150 ) (0.6 ) 456 2.1 (132.9 ) Net earnings $ 5,116 20.8 $ 3,431 15.2 49.1 Net earnings per share (Diluted) $ 2.10 $ 1.41 48.9 Average shares outstanding (Diluted) 2,439.0 2,427.1 Effective tax rate (3.0 ) % 11.7 % Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 7,046 28.7 $ 5,421 24.1 30.0 Net earnings $ 6,009 24.5 $ 4,946 22.0 21.5 Net earnings per share (Diluted) $ 2.46 $ 2.04 20.6 Effective tax rate 14.7 % 8.8 % (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) TWELVE MONTHS 2025 2024 Percent Increase (Decrease) Amount Percent to Sales Amount Percent to Sales Sales to customers $ 94,193 100.0 $ 88,821 100.0 6.0 Cost of products sold 30,256 32.1 27,471 30.9 10.1 Gross Profit 63,937 67.9 61,350 69.1 4.2 Selling, marketing and administrative expenses 23,676 25.1 22,869 25.7 3.5 Research and development expense 14,665 15.6 17,232 19.4 (14.9 ) In-process research and development impairments 81 0.1 211 0.2 Interest (income) expense, net (85 ) (0.1 ) (577 ) (0.6 ) Other (income) expense, net (7,209 ) (7.6 ) 4,694 5.3 Restructuring 228 0.2 234 0.3 Earnings before provision for taxes on income 32,581 34.6 16,687 18.8 95.2 Provision for taxes on income 5,777 6.1 2,621 3.0 120.4 Net earnings $ 26,804 28.5 $ 14,066 15.8 90.6 Net earnings per share (Diluted) $ 11.03 $ 5.79 90.5 Average shares outstanding (Diluted) 2,429.4 2,429.4 Effective tax rate 17.7 % 15.7 % Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 31,681 33.6 $ 28,979 32.6 9.3 Net earnings $ 26,215 27.8 $ 24,242 27.3 8.1 Net earnings per share (Diluted) $ 10.79 $ 9.98 8.1 Effective tax rate 17.3 % 16.3 % (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measures Fourth Quarter Twelve Months Ended (Dollars in Millions Except Per Share Data) 2025 2024 2025 2024 Net Earnings, after tax- as reported $5,116 $3,431 $26,804 $14,066 Pre-tax Adjustments Litigation related 854 (16) (6,040) 5,450 Intangible Asset Amortization expense 1,186 1,171 4,621 4,526 Restructuring related 1 210 62 512 269 Acquisition, integration and divestiture related (190) 298 285 1,226 IPR&D impairments 81 17 81 211 (Gains)/losses on securities (100) (68) (427) 306 Orthopaedics Separation related 48 - 48 - COVID-19 Vaccine related costs - 23 - 100 Medical Device Regulation - 47 - 204 Other (9) - 20 - Tax Adjustments Tax impact on special item adjustments 2 (445) (80) 381 (2,135) Tax legislation and other tax related (742) 61 (70) 19 Adjusted Net Earnings, after tax $6,009 $4,946 $26,215 $24,242 Average shares outstanding (Diluted) 2,439.0 2,427.1 2,429.4 2,429.4 Adjusted net earnings per share (Diluted) $2.46 $2.04 $10.79 $9.98 Operational adjusted net earnings per share (Diluted) $2.35 $10.58 Notes: 1 In fiscal 2023, the company completed a prioritization of its research and development (R&D) investment within the Innovative Medicine segment to focus on the most promising medicines with the greatest benefit to patients. This resulted in the exit of certain programs within therapeutic areas. The R&D program exits were primarily in infectious diseases and vaccines including the discontinuation of its respiratory syncytial virus (RSV) adult vaccine program, hepatitis and HIV development. The restructuring expense of $102 million in fiscal 2024 included the termination of partnered and non-partnered program costs, asset impairments and asset divestments. This program was completed in Q4 2024. In fiscal 2023, the company initiated a restructuring program of its Orthopaedics franchise within the MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The restructuring expense of $162 million in the fiscal fourth quarter of 2025 ($307 million Q4 2025 YTD) and $60 million in the fiscal fourth quarter of 2024 ($167 million Q4 2024 YTD) primarily includes costs related to market and product exits. This program was substantially completed in Q4 2025. In fiscal 2025, the company initiated a restructuring program of its Surgery franchise within the MedTech segment to simplify and focus operations by exiting certain non-strategic product lines and optimize select sites across the network. The restructuring expense of $48 million in the fiscal fourth quarter of 2025 ($205 million Q4 2025 YTD) primarily includes costs related to asset impairments and market and product exits. This program is expected to be substantially completed by the end of fiscal year 2026. 2 The tax impact related to special item adjustments reflects the current and deferred income taxes associated with the above pre-tax special items in arriving at adjusted earnings. Contacts Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com Read full story here

iStock, SIphotography Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line. Protagonist CEO Dinesh Patel has a big decision to make. It could be worth as much as $400 million—and much more later on. The submission of a new drug application for rare blood cancer therapy rusfertide by partner Takeda at the end of December triggered a three-month countdown for Protagonist to decide whether to opt in or out on 50-50 co-development. If Protagonist opts out, the company would be eligible for $400 million in opt-out payments, larger milestone payments and 14%–29% tiered royalties on worldwide sales. “Now the clock is ticking,” Patel told BioSpace on the sidelines of the J.P. Morgan Healthcare Conference in San Francisco on Wednesday. Opting out would also allow Protagonist to leave the development and commercial process to Takeda, clearing the way for an increased focus on the biotech’s wholly owned pipeline. “What we have started expressing is we are strongly leaning towards opting out,” Patel said. “And the reason for that is like the economics around opting out are just amazing.” That’s because rusfertide aced its clinical program. The drug is being developed for polycythemia vera, a type of rare and incurable cancer that causes the bone marrow to produce too many red blood cells. Patients are currently treated by removing blood from the body to manage elevated hemocrit levels—a procedure that can cause fatigue, visual disturbances and other complications. In the Phase III VERIFY trial that read out last year , rusfertide reduced the need for blood withdrawals and lowered hemocrit levels as compared to placebo. The secondary endpoints, which looked at symptoms and treatment improvements, were also met. “All of a sudden it’s like, oh, this could be a big drug,” Patel said. The results put the 29% royalty in sight, Patel said. If the trial had not been so successful, opting in would have been a better option with lower potential royalties expected. But now, for any sales beyond $1.5 billion, Protagonist will receive 29% royalties. Meanwhile, Takeda will be doing the API sourcing, manufacturing, erecting the sales force to drive prescriptions and setting up direct-to-consumer engagement. “Without lifting a finger, I’m getting such a big share,” Patel said. The FDA has granted priority review for rusfertide, and a decision is expected in the next few months or by August, according to Patel. Phase III Takeda-Protagonist Drug for Incurable Cancer Reduces Need for Blood Withdrawals in Phase III Trial Protagonist Therapeutics notches a milestone in its pact with Takeda for rusfertide. New data show that many patients with a chronic blood cancer taking the drug didn’t need to have their blood removed to bring down dangerously high hemocrit levels. March 3, 2025 · 2 min read · Annalee Armstrong Gold Nuggets Rusfertide is not Protagonist’s only partnership—or its only new drug application before the FDA. The company is also working with Johnson & Johnson on icotrokinra, an IL-23 receptor blocker under development for multiple immunology and inflammatory diseases. The drug has been heralded as a “new standard of treatment” in plaque psoriasis after Phase III results were released in March 2025 . The NDA was filed in July last year, with a decision expected in the middle of the year. Meanwhile, J&J—and Takeda—are working hard to launch Protagonist’s therapies right away. “That’s a very nice setup,” Patel said. J&J was rumored to be interested in acquiring Protagonist over the fall. A deal has yet to materialize, and Patel declined to comment. But he did say that Protagonist has no interest in becoming a commercial company. The focus will remain on developing new treatments, including a handful of oral obesity assets that will go up against Novo Nordisk and Eli Lilly. The partnership structure the team has built means Protagonist has a solid financial outlook, with milestones to support along the way. “We are laser-focused on the future,” Patel said. “All the nuggets we have in the next wave of R&D.”