• Two New U.S. FDA Approvals in FY2023 Q3: FRUZAQLA for Adults With Previously Treated Metastatic Colorectal Cancer and ADZYNMA for Ultra-Rare Blood Clotting Disorder cTTP
• Strong Commercial Execution Maximizing Value of Existing Portfolio:
• ENTYVIO^® Pen Launched in U.S. for Ulcerative Colitis; U.S. FDA Approval Decision on Crohn’s Disease Filing Expected in early FY2024
• QDENGA ^® Dengue Vaccine Now Launched in 21 Countries
• LIVTENCITY ^® Approved in China for Refractory Post-Transplant CMV
• Revenue Growth of +4.6% at Actual Exchange Rate (AER); Flat at Constant Exchange Rate (CER)
• Core Operating Profit Change of -12.7% at CER, Reflecting Generic Impact, Lower Coronavirus Vaccines Revenue and Increased Investment in R&D and Data, Digital & Technology
• Life-Cycle Management Approvals for HYQVIA^® and GAMMAGARD LIQUID^® in January Support Forward Momentum of Growth & Launch Products
• Confirms Full-Year Management Guidance

OSAKA, Japan & CAMBRIDGE, Mass. / Feb 01, 2024 / Business Wire / Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the third quarter of fiscal year 2023 (period ended December 31, 2023). With year-to-date strong momentum in its Growth & Launch Products (+12.7% at CER) offsetting the significant revenue impact of generic entrants, Takeda remains on track towards its full-year Management Guidance.

Takeda chief financial officer, Costa Saroukos, commented:

“In FY2023 Q3 we made further progress in our vision to discover and deliver life-transforming treatments, receiving two new U.S. FDA approvals and broadening the reach of our existing portfolio with multiple life-cycle management approvals for our Growth & Launch Products.

“We remain on track towards our full-year Management Guidance at CER, reflecting significant generic impact, lower coronavirus vaccines revenue and investment in R&D and data, digital and technology to secure our long-term competitiveness, as well as continued strong momentum in our Growth & Launch Products.

“We continue to improve our debt profile with 100% of our debt now at fixed interest rates averaging 1.6%, and our financial foundation remains strong as we enter the fourth quarter of FY2023.”

*Free Cash Flow forecast reflects expenditures related to the acquisition of TAK-279 from Nimbus and in-licensing of FRUZAQLA (fruquintinib) from HUTCHMED.

Additional Information About Takeda’s FY2023 Q3 Earnings Results

For more details on Takeda’s FY2023 Q3 results and other financial information, including key assumptions in FY2023 forecast and management guidance, please click here.

For more information on Takeda’s commercial progress across the five key business areas and pipeline updates, please visit: https://takeda.info/qr2023_q3_qfr_en

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 www.takeda.com.

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Financial information and Certain Non-IFRS Financial 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, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, EBITDA, Adjusted EBITDA and Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this presentation. 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. By including these non-IFRS measures, management intends to provide investors with additional information to further analyze Takeda’s performance and core results, including when controlling for the effect of fluctuations in exchange rates. 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 financial measures to their most directly comparable IFRS measures, which are in the financial appendix at the end of Takeda's FY2023 Q3 investor presentation (available at takeda.com/investors/financial-results/quarterly-results/).

Medical information

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Please refer to slide 17 of Takeda’s FY2023 Q3 investor presentation (available at takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.