Company Announcements

• Revenue Growth of +13.4% at Actual Exchange Rates (AER); +5.0% at Constant Exchange Rate (CER) Driven by Continued Advancement of Growth & Launch Products (+18.7% at CER)
• Core Operating Profit Increase of +12.9% at CER; Core Operating Profit Margin of 30.2%
• Double-Digit Revenue Growth of ENTYVIO^® at CER Driven by Launch of ENTYVIO^® Pen in the U.S.
• Geographical Expansion with Approvals of ADZYNMA^® in EU and FRUZAQLA^® in Japan
• Late-Stage Pipeline Advances with the Start of Phase 3 Trial of TAK-861 in Narcolepsy Type 1
• Company will Hold R&D Day for Investors and Media on December 12 (Eastern) / 13 (Japan)

OSAKA, Japan--(BUSINESS WIRE)--Oct. 31, 2024-- Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first half of fiscal year 2024 (six months ended September 30, 2024), with continued momentum in its Growth & Launch Products driving growth. The company has upgraded its full year forecasts and Management Guidance to reflect stronger than anticipated first-half performance (including milder than anticipated generic erosion of VYVANSE^® in the U.S.) and revised foreign exchange assumptions.

The strong performance of Takeda’s Growth and Launch Product portfolio, which grew 18.7% at CER and represented 47% of total revenue, reinforces the company’s confidence in returning to sustainable revenue and profit growth.

The initiation of TAK-861’s Phase 3 trial in August for narcolepsy type 1 demonstrates Takeda’s strength in advancing its promising late-stage pipeline to develop life-transforming treatments. More details on the company’s R&D strategy and pipeline updates, including commercial prospects, will be presented at Takeda’s R&D Day taking place on December 12 (EST) / 13 (JST), 2024.

Takeda chief executive officer, Christophe Weber, commented:
“In the first half of fiscal year 2024, we made further progress in advancing our pipeline, including the initiation of our TAK-861 Phase 3 trial for narcolepsy type 1. Our late-stage programs continue to advance, with several in Phase 3 development this fiscal year, and have the potential to transform the lives of patients around the world.

“Our commercial execution has positioned us for sustainable growth despite a dynamic and competitive environment. Bolstered by the continued strong performance of our Growth & Launch Products, including a return to double-digit growth of ENTYVIO^®, lifecycle management approvals and successful launches of new products such as FRUZAQLA^® in our oncology portfolio, our business and long-term outlook remains strong.”

Takeda chief financial officer, Milano Furuta, commented:
“We are upgrading our FY2024 full year outlook, reflecting stronger than anticipated first half performance as well as updated foreign exchange assumptions for the year. Full-year guidance reflects our intention to increase R&D investment in the second half to support our late-stage pipeline.

“We remain confident in delivering sustainable growth with our Growth & Launch Products and promising late-stage pipeline. Implementation of our multi-year program to improve our efficiency through organizational agility, procurement savings and data, digital and technology is progressing as planned. We continue to drive these initiatives to improve our Core Operating Profit Margin from FY2025 towards our low-to-mid 30s% target.”

FY2024 Outlook
Updating Full Year Management Guidance, and Reported and Core Forecasts

Takeda’s FY2024 Management Guidance has been upgraded, primarily due to milder than anticipated generic erosion of VYVANSE and strong business momentum. Furthermore, also reflecting expected foreign exchange rates during the remaining second half of FY2024, Takeda’s FY2024 reported and Core forecasts have been revised from the original forecast.

Additional Information About Takeda’s FY2024 H1 Results
For more details about Takeda’s FY2024 H1 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 Q2 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.

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. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners.

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. 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; competitive pressures and developments; changes to applicable laws and regulations; 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: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. 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 FY2024 Q2 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).

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.

Please refer to slide 5 of Takeda’s FY2024 Q2 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241030235134/en/

Investor Relations
Christopher O’Reilly
Christopher.oreilly@takeda.com
+81 (0) 90-6481-3412

Media Relations
Brendan Jennings
Brendan.jennings@takeda.com
+81 (0) 80-2705-8259
(Outside Japan business hours)
Media_relations@takeda.com

Source: Takeda Pharmaceutical Company Limited