Takeda Pharmaceutical Reports Strong Q1 FY2024 Results, Driven by Growth and Launch Products

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

Late-Stage Pipeline Advances with Positive Phase 2b Data Presented for TAK-861 in Narcolepsy Type 1 and Mezagitamab for Immune Thrombocytopenia (ITP) OSAKA, Japan--(BUSINESS WIRE)--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. 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 (NYSE:TAK) 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 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). 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 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.

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. 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 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). 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 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.