Takeda continues to advance multiple late-stage programs and is on track for three Phase 3 data readouts within the calendar year 2025. The company expects three regulatory filings in FY2025-FY2026 and five additional regulatory filings in FY2027-FY2029. Six of these late-stage programs are estimated to have the potential to generate peak revenues ranging from USD 10 billion to 20 billion in total and contribute to long-term growth.
"As highlighted at our R&D Day in December 2024, we are on track to three Phase 3 data readouts within calendar year 2025, strengthening confidence in our long-term growth outlook.
"The announcement of our new share buyback program, approved by Takeda’s Board of Directors, demonstrates our commitment to shareholder returns."
Takeda has upgraded its FY2024 Management Guidance, primarily driven by product momentum and OPEX savings. In addition, and also reflecting revised foreign exchange assumptions for the year, Takeda has raised its FY2024 reported and Core forecasts from the previous forecast. For more details, see release: Notice of the Revised Forecast of Consolidated Financials for FY2024 (IFRS)
| FY2024 Management Guidance Core Change at CER (Non-IFRS) |
| | FY2024 PREVIOUS
MANAGEMENT GUIDANCE
(October 2024) | FY2024 REVISED
MANAGEMENT GUIDANCE
(January 2025) |
| Core Revenue | Flat to slightly increasing | Low-single-digit % increase |
| Core Operating Profit | Mid-single-digit % decline | Low-single-digit % increase |
| Core EPS (Yen) | Approx 10% decline | Flat to slightly declining |
| FY2024 Reported and Core Forecasts |
| (Billion yen, except percentages and per share amounts) |
| | FY2024
PREVIOUS FORECAST (October 2024) | FY2024 REVISED FORECAST (January 2025) |
| Revenue | 4,480.0 | 4,590.0 |
| Core Revenue (Non-IFRS) | 4,480.0 | 4,590.0 |
| Operating Profit | 265.0 | 344.0 |
| Core Operating Profit (Non-IFRS) | 1,050.0 | 1,150.0 |
| Net Profit | 68.0 | 118.0 |
| EPS (Yen) | 43 | 75 |
| Core EPS (Yen) (Non-IFRS) | 456 | 507 |
| Adjusted Free Cash Flow (Non-IFRS) | 400.0-500.0 | 550.0-650.0 |
| Annual Dividend per Share (Yen) | 196 | 196 |
Positive Momentum in High-Value, Late-Stage Pipeline
The company is building strong momentum with its high-value, late-stage programs. The transformative value these programs can deliver to patients, as well as the significant revenue potential through 2030 and beyond, were presented at the R&D Day event held in December 2024.
Among the multiple late-stage programs presented, the company expects three Phase 3 data readouts in the calendar year 2025 with filings anticipated in FY2025-FY2026 for the following programs and indications:
-
oveporexton (TAK-861) for the treatment of narcolepsy type 1,
-
zasocitinib for the treatment of psoriasis, and
-
rusfertide for the treatment of polycythemia vera, a rare chronic blood disorder
Moreover, five additional indication filings for late-stage programs are on pace for FY2027-FY2029.
-
zasocitinib for the treatment of psoriatic arthritis,
-
mezagitamab for treatments of immune thrombocytopenia (ITP), a rare immune-mediated bleeding disorder, and immunoglobulin A nephropathy (IgAN), a chronic progressive autoimmune mediated kidney disease,
-
fazirsiran for the treatment of alpha-1 antitrypsin deficiency-associated liver disease, and
-
elritercept for the treatment of anemia associated with myelodysplastic syndrome
Beyond its high-value, late-stage pipeline, Takeda will continue advancing its early-stage pipeline and focusing on strategic business development opportunities, to deliver treatments that have the potential to change patients’ lives.
Additional Information About Takeda’s FY2024 Q3 YTD Results
For more details about Takeda’s FY2024 Q3 YTD 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 Q3 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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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 Q3 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).
Peak Sales and PTRS Estimates
References in this press release to peak revenue potential ranges are estimates that have not been adjusted for probability of technical and regulatory success (PTRS) and should not be considered a forecast or target. These peak revenue potential ranges represent Takeda’s assessments of various possible future commercial scenarios that may or may not occur.
References in this press release to PTRS are to internal estimates of Takeda regarding the likelihood of obtaining regulatory approval for a particular product in a particular indication. These estimates reflect the subjective judgment of responsible Takeda personnel and have been approved by Takeda’s Portfolio Review Committee for use in internal planning.
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 Q3 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.
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Contacts
Investor Relations
Christopher O’Reilly
Christopher.oreilly@takeda.com
+81 (0) 90-6481-3412
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Brendan Jennings
Brendan.jennings@takeda.com
+81 (0) 80-2705-8259
(Outside Japan business hours)
Media_relations@takeda.com
