Takeda Announces First Quarter FY2024 Results - Strong Performance by Growth & Launch Products; Advancements in Promising Late-Stage Pipeline

• Revenue Growth of 14.1% at Actual Exchange Rates (AER); +2.1% at Constant Exchange Rate (CER) Driven by Acceleration of Growth & Launch Products (+17.8% at CER)
• Core Operating Profit Increase of 4.5% at CER Reflecting Phasing of R&D Investment and Other OPEX Reduction; Core Operating Profit Margin of 31.6% for the Quarter
• No Change to Full Year Forecast or Management Guidance
• Geographic Expansion with Approvals of LIVTENCITY^® in Japan and FRUZAQLA^® in EU
• Late-Stage Pipeline Advances with Positive Phase 2b Data Presented for TAK-861 in Narcolepsy Type 1 and Mezagitamab for Immune Thrombocytopenia (ITP)

Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first quarter of fiscal year 2024 (period ended June 30, 2024), with continued momentum in its Growth & Launch Products driving Core growth at CER and more than offsetting revenue impact resulting from significant losses of exclusivity that occurred in the previous fiscal year.

The strong performance of Takeda’s Growth and Launch Product portfolio, which grew 17.8% at CER and represented 46% of total revenue, supports the company’s outlook for a return to sustainable revenue and profit growth in the near term and its ability to deliver life-transforming treatments and vaccines.

In addition, positive Phase 2b data presented in June for TAK-861 in narcolepsy type 1 and for mezagitamab (TAK-079) in immune thrombocytopenia (ITP), a rare immune-mediated bleeding disorder, underscore the promise of Takeda’s late-stage pipeline and the potential for strong revenue growth into the next decade and beyond.

Takeda chief financial officer, Milano Furuta, commented:

“Takeda has delivered a positive first quarter performance, with Growth and Launch Products driving overall revenue growth. Our results reflect strong commercial execution, with new launches, geographic expansion and lifecycle management enabling us to reach more patients and communities around the world.

“First quarter Core Operating Profit benefitted from this strong Growth and Launch Product performance, as well as from phasing of R&D investment, reduction in other OPEX and milder than anticipated VYVANSE^® generic erosion in the U.S.

“There is no change to our full-year FY2024 outlook announced in May. We expect the impact of generic erosion to accelerate in coming quarters and the phasing of our R&D investment will focus on the second half of the year due to the planned initiation of multiple Phase 3 programs. Foreign exchange has been a tailwind for revenue performance in the first quarter and we see potential upside to our revenue forecast if current foreign exchange rates continue.”

Additional Information About Takeda’s FY2024 Q1 Results

For more details about Takeda’s FY2024 Q1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2024 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2024 Q1 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/)

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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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 FY2024 Q1 investor presentation (available at www.takeda.com/investors). Beginning in the quarter ended June 30, 2024, Takeda (i) changed its methodology for CER adjustments to results of subsidiaries in hyperinflation countries to present those results in a manner consistent with IAS 29, Financial Reporting in Hyperinflation Economies, (ii) re-named Free Cash Flow as previously calculated as “Adjusted Free Cash Flow” (with “Free Cash Flow” to be reported as Operating Cash Flow less Property, Plant and Equipment), and (iii) re-named Net Debt as previously calculated as “Adjusted Net Debt” (with “Net Debt” to be reported as the book value of bonds and loans less cash and cash equivalents).

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Please refer to slide 8 of Takeda’s FY2024 Q1 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.

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