Takeda Provides Pipeline Update and Shares Goal to Increase Revenue 50% by FY2030 at the 39th Annual J.P. Morgan Healthcare Conference
− Goal to Reach
− Wave 1 Pipeline Portfolio Includes 12 New Molecular Entities Targeted for Launch by FY2024 Representing Best-in-Class/First-in-Class Therapies with Significant Market Potential
− Rapid Deleveraging On Track to Achieve Target of 2x Net Debt / adjusted EBITDA within Fiscal Years 2021 to 2023
“In 2020, Takeda demonstrated the resilience of our business model, the depth of our portfolio and the commitment of our employees as we continued to serve patients and communities globally while overcoming challenges posed by the COVID-19 pandemic,” said
Highly Innovative Pipeline Supports Sustained Growth
Takeda has built a world-class, state-of-the-art, externally-facing R&D engine and has generated an innovative and modality diverse pipeline of approximately 40 clinical-stage new molecular entities (NMEs). Takeda’s pipeline portfolio has the potential to contribute significantly to revenue growth and the company has a goal to reach
The majority of revenue growth is expected to come from the company’s Wave 1 pipeline, which includes 12 unique NMEs, representing potential best-in-class/first-in-class therapies and its existing 14 global brands.
Takeda’s Wave 1 programs include five that have received a Breakthrough Therapy designation and three that were granted fast track designation by the
Beyond the Wave 1 pipeline, Takeda’s research engine, which comprises internal research capabilities and more than 200 active partnerships, is rapidly advancing a steady stream of next-generation therapies in Wave 2 of our pipeline that will provide sustained growth in FY2025 and beyond. These Wave 2 early-clinical and preclinical programs are designed to provide transformative or curative potential for targeted populations with high unmet need across core therapeutic areas. They are based on targets with strong human validation, represent diverse modalities and leverage new platform capabilities in cell therapy, gene therapy and data sciences.
Takeda's tetravalent dengue vaccine candidate (TAK-003) has the potential to help address the massive global burden of dengue including key priorities for dengue control such as protection of seronegative individuals (persons not previously exposed to dengue) and prevention of hospitalization. TAK-003 is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses. The TAK-003 development program includes the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES), a double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents. The TIDES trial is continuing, and safety and efficacy will be assessed over a total of four and a half years. Dengue is the fastest spreading mosquito-borne viral disease and was recognized by WHO to be one of the top ten threats to global health in 2019. Approximately half of the world's population now lives under the threat of dengue, which is estimated to cause 390 million infections each year.
Takeda’s TAK-755 has the potential to be a transformative therapy for thrombotic thrombocytopenic purpura (TTP), a rare and life-threatening clotting disorder defined by low or absent circulating ADAMTS13 activity (an enzyme essential for regulation of normal blood clotting). There is very high unmet need for new therapies for both congenital and immune-mediated TTP, and TAK-755 is the first and only ADAMTS13 replacement therapy currently in development for both types of TTP. If approved, TAK-755 could be the only replacement therapy to rapidly and completely correct ADAMTS13 levels, and positively impact morbidity and mortality. If approved, TAK-755 has the potential to be first-in-class and the therapeutic choice for prophylaxis in congenital TTP, and a best-in-class therapy for the treatment of immune-mediated TTP. TAK-755 could simplify treatment, avoid adverse events related to plasma-derived therapy and plasma exchange, and provide the potential for at-home therapy. Data readouts are currently expected in 2021 for a phase 2 trial in immune-mediated TTP and in 2022 for a pivotal Phase 3 trial in congenital TTP.
Developed in collaboration with the
TAK-994 & TAK-925
TAK-994 is the first oral selective orexin 2 receptor agonist to enter clinical development for the treatment of narcolepsy type 1 (NT1), a rare neurologic condition characterized by excessive daytime sleepiness, cataplexy (signs and symptoms of the disease) and is due to a loss of orexin producing neurons. TAK-994 is currently being evaluated in an ongoing Phase 2 clinical trial in narcolepsy (SPARKLE-1501). If approved, TAK-994 may be the first treatment to address the underlying biology of the disease. TAK-925 (IV formulation) has published proof-of-concept data in NT1, narcolepsy type 2 (NT2), and shift work sleep disorder. Data for idiopathic hypersomnia and obstructive sleep apnea will be disclosed in the future.
Takeda is committed to maintaining investment grade credit ratings and remains on track towards its medium-term target of 2x Net Debt/adjusted EBITDA ratio within the fiscal years 2021 to 2023, with rapid de-leveraging driven by strong cash flow and proceeds from non-core asset divestitures. In the first half of FY2020, Takeda exceeded its
Takeda has solid growth momentum and potential for accelerated underlying growth over the medium term. Takeda is also on track to achieve our targeted annual run rate of
Slides from the
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
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.
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” 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
Certain Non-IFRS Financial Measures
This press release and materials distributed in connection with this press release include certain IFRS financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”), such as Underlying Revenue, Core Operating Profit, Underlying Core Operating Profit, Core Net Profit, Underlying Core EPS, 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 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. By including these non-IFRS measures, management intends to provide investors with additional information to further analyze Takeda’s performance, core results and underlying trends. 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 reconciliation of non-IFRS financial measures to their most directly comparable IFRS measures.
Further information on certain of Takeda’s Non-IFRS measures, including reconciliations to the most comparable measures presented under IFRS, is posted on Takeda’s investor relations website at https://www.takeda.com/investors/reports/quarterly-announcements/
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.
1 Includes incremental revenues on a non-PTS (probability of technical success) basis (i.e., figures represent best case scenarios, including technical success that Takeda does not currently consider probable to occur and should not be seen as a forecast or target figure). On a PTS-adjusted basis, Takeda expects revenue CAGR to be in the low single digits between FY2019 and FY2030. Does not include any potential impacts imposed by the Most Favored Nation Model interim final rule issued by the
+81 (0) 3-3278-2095
Media Outside Japan
+81 (0) 3-3278-2543