Zasocitinib

Solid first quarter performance broadly in line with guidance, underpinned by resilient demand across core in-line brands Commercial execution and late-stage pipeline investments on schedule, including first approval for ORZEYFUL TM (oveporexton) in China, setting the foundation for next wave of medicines No change to FY2026 full-year forecast and management guidance OSAKA, Japan--(BUSINESS WIRE)--Takeda ( TOKYO:4502/NYSE:TAK ) announced financial results for the first quarter of fiscal year 2026 (April 1, 2026 to June 30, 2026), marking a period of disciplined execution and operational momentum. Takeda leveraged the resilient performance of its core in-line portfolio to support its long-term strategy, advancing commercial launch preparations and driving critical R&D pipeline milestones. With a clear operational trajectory established in the first quarter and under a new operating model, Takeda remains on track to deliver its strategic and financial commitments for the fiscal year. FY2026 First Quarter Highlights Revenue increased by +10.2% versus the prior-year period on an actual exchange rate (AER) basis and decreased by -0.5% on a Constant Exchange Rate (CER) basis as the negative impact of the loss of exclusivity of VYVANSE® was largely offset by growth from core in-line brands. Core Operating Profit increased by +11.5% on an AER basis and decreased by -0.5% on a CER basis, reflecting continued growth investments supported by the transformation program. Reported Operating Profit increased by +9.1% on an AER basis. Core EPS increased by +1.5% at AER and decreased by -11.8% at CER, while Reported EPS decreased by -9.8% YoY. Adjusted Free Cash Flow amounted to JPY 68.6 billion. Launch preparations for key late-stage pipeline assets (ORZEYFUL, rusfertide and zasocitinib) are progressing on schedule, with the first approval for ORZEYFUL achieved in China. FY2026 full-year outlook remains unchanged. A Capital Markets Day will be held on December 11, 2026, in Tokyo, Japan. Takeda President and Chief Executive Officer, Julie Kim, commented: “Our solid performance this quarter marks a good start to the fiscal year and keeps us on track to achieve our full-year targets. “This quarter’s results reflect our unwavering commitment to financial discipline and the progressing execution of our enterprise transformation. The efficiencies unlocked by this ongoing program are directly fueling our highest priorities in Horizon One in our two-horizon growth strategy: the successful launch of three medicines that have the potential to be blockbuster brands, the advancement of our late-stage pipeline, the enduring resilience of our core in-line portfolio and new capabilities and efficiencies gained through transformation. We look forward to sharing the detailed strategic roadmap for these two growth horizons at our Capital Markets Day in December.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Takeda Chief Financial Officer, Milano Furuta, commented: “Our first-quarter performance is tracking consistently with management guidance, with the resilience of our core in-line brands largely offsetting our mature portfolio decline, and OPEX savings through the transformation program being strategically reinvested to fund future growth opportunities. Our full-year forecast and guidance remain unchanged.” FINANCIAL HIGHLIGHTS for First Quarter Results ended June 30, 2026 (Billion yen, except percentages and per share amounts) Item FY2026 Q1 (Billion JPY) FY2025 Q1 (Billion JPY) YoY (AER) Revenue 1,219.9 1,106.7 +10.2% Operating Profit 201.4 184.6 +9.1% Margin 16.5% 16.7% -0.2pp Net Profit 113.2 124.2 -8.9% EPS (Yen) 72 79 -9.8% Operating Cash Flow 127.6 215.4 -40.8% Adjusted Free Cash Flow (Non-IFRS) 68.6 190.1 -63.9% Core (Non-IFRS) (Billion yen, except percentages and per share amounts) Item FY2026 Q1 FY2025 Q1 YoY (AER) YoY (CER) Revenue 1,219.9 1,106.7 +10.2% -0.5% Operating Profit 358.9 321.8 +11.5% -0.5% Margin 29.4% 29.1% +0.3pp Net Profit 242.9 237.0 +2.5% -10.9% EPS (Yen) 154 151 +1.5% -11.8% FY2026 Full-year Forecast and Guidance There are no changes to the FY2026 forecast and management guidance announced on May 13, 2026. (Billion yen, except percentages and per share amounts) Item FY2026 FORECAST FY2026 MANAGEMENT GUIDANCE Core change at CER (Non-IFRS) Revenue 4,640.0 — Core Revenue (Non-IFRS) 4,640.0 Low-single digit % decline Operating Profit 420.0 — Core Operating Profit (Non-IFRS) 1,160.0 5% to 8% decline Net Profit 166.0 — EPS (Yen) 104 — Core EPS (Yen) (Non-IFRS) 472 Mid-teens % decline Adjusted Free Cash Flow (Non-IFRS) 650.0 – 750.0 — Annual dividend per share (Yen) 204 — Pipeline Progress Building the Foundation for Future Growth Takeda’s next-generation growth engine is anchored by three, high-potential, late-stage pipeline assets expected to obtain regulatory approvals in the U.S. and other key regions in the coming year. While this represents a pivotal period of strategic investment and commercial launch execution, Takeda is positioned to deliver tangible milestones over the next 12 to 24 months. By establishing a track record of launch excellence today, Takeda is securing the foundation that will underpin the Company’s sustained, long-term growth and meaningful impact for patients globally. ORZEYFUL An orexin receptor agonist with a first-in-class mechanism of action, designed to address the orexin deficiency that causes narcolepsy type 1 (NT1). The first approval of oveporexton was recently granted in China under the brand name ORZEYFUL. New drug applications are currently under review in the United States and Japan. Preparations for the expected launches in the U.S., Japan and China in the second half of the year are well underway. At SLEEP 2026, Takeda presented Phase 3 clinical trial results for ORZEYFUL demonstrating improvements in daily functioning, cognition and nighttime sleep in patients with narcolepsy type 1. Rusfertide A potential first-in-class hepcidin mimetic for the treatment of adults with the blood cancer polycythemia vera (PV). Demonstrated significant improvements in hematocrit control and phlebotomy reduction for patients with PV in a Phase 3 clinical trial . Granted Priority Review by the U.S. FDA, Takeda is prepared for a commercial U.S. launch expected in the second half of 2026. Zasocitinib A next generation, highly selective and potent TYK2 inhibitor that has demonstrated rapid, durable skin clearance in a convenient once-daily oral pill with no fasting restrictions. Achieved positive topline results across the primary endpoint and all key secondary endpoints in a head-to-head Phase 3 clinical trial against deucravacitinib. Achieved consistent, high rates of skin clearance across the body, including hard-to-treat and high-impact sites in Phase 3 psoriasis studies. Takeda is making the necessary investments with a view toward regulatory submissions in 2026 and a commercial launch anticipated in the first half of 2027. Capital Allocation and Shareholder Returns Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation with the goal of driving growth and enabling the company to deliver returns to shareholders under its progressive dividend policy. The annual dividend forecast for FY2026 is JPY 204 per share. Additional Information Regarding FY2026 First Quarter Results Takeda will host a conference call for investors and analysts on Thursday, July 30, 2026, at 19:00 Japan Time / 6:00 U.S. Eastern Time to discuss its FY2026 first quarter results. A live webcast of the conference call and the presentation materials will be available in the Investor Relations section of Takeda’s website ( ). The presentation materials include details on Takeda’s FY2026 first quarter results, business progress and pipeline updates, as well as definitions of non-IFRS measures. Note: ORZEYFUL is the proprietary name approved in China for oveporexton. References to ORZEYFUL are provided for consistency only and should not be interpreted as indicating regulatory approval or acceptance of the proprietary name in jurisdictions where the product remains under regulatory review About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. 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These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: or at . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Financial information and Non-IFRS Measures Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”). This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2026 Q1 investor presentation (available at ). Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Contacts Investor Relations Christopher O’Reilly Takeda.ir.contact@takeda.com Media Relations Shoko Honda toiawase_kouhou@takeda.co.jp (Tokyo) media_relations@takeda.com (Boston)

InnoCare Pharma announced Monday that its oral tyrosine kinase 2 (TYK2) inhibitor fadeucravacitinib met the primary endpoint in a phase 3 trial of adults with moderate-to-severe plaque psoriasis. The study demonstrated that fadeucravacitinib, also known as ICP-488, produced a clinically meaningful improvement, while multiple secondary endpoints were also met, according to the release . InnoCare said the drug demonstrated a favorable safety profile but did not disclose detailed efficacy or safety data. The randomized, double-blind phase 3 study evaluated the safety and efficacy of fadeucravacitinib compared with placebo in Chinese adults with moderate-to-severe plaque psoriasis. In October 2024, the Beijing-based biopharmaceutical company reported positive phase 2 results , with 77.3% and 78.6% of patients in two dose groups achieving at least a 75% improvement on the Psoriasis Area and Severity Index at week 12, compared with 11.6% of patients who received placebo. The response rates were in the range of results previously reported for Bristol Myers Squibb’s approved oral TYK2 inhibitor Sotyktu, although the drugs have not been compared in a head-to-head trial. Moderate-to-severe plaque psoriasis is a chronic, immune-mediated condition characterized by plaques on the skin. Globally, psoriasis affects 125 million people, including approximately 8.66 million people in China, according to the release. “Existing treatment options do not fully address the needs of psoriasis patients and there is a particularly high demand for novel oral therapies,” InnoCare CEO and co-founder Jasmine Cui, Ph.D., said in the release. “We will work to complete the Phase III study and plan to advance the regulatory filing to bring better treatment options to patients with psoriasis and other autoimmune diseases.” Fadeucravacitinib is an oral, potent and selective TYK2 inhibitor that blocks signaling by inflammatory cytokines including IL-23, IL-12 and type 1 interferon. The drug targets the same signaling pathway as Takeda’s zasocitinib and BMS’ Sotyktu. Takeda recently reported that zasocitinib beat Sotyktu’s active ingredient, deucravacitinib, across the primary and key secondary endpoints of a head-to-head phase 3 trial. Takeda has also reported secondary endpoint results from two other late-stage studies of patients with moderate-to-severe plaque psoriasis, including measures of clearance in hard-to-treat areas such as the scalp, palms and soles of the feet. The trials compared zasocitinib with placebo and Amgen’s Otezla. In the two studies, 42% and 30% of patients treated with zasocitinib achieved clear or almost clear skin in certain hard-to-treat areas by week 16. InnoCare plans to complete the ongoing phase 3 study, including its long-term safety follow-up, before advancing a regulatory filing. Detailed efficacy and safety data are expected to be published or presented at an upcoming scientific meeting.