Takeda’s Pipeline Has Potential to Contribute Significantly to Revenue Growth Over Next Decade
Company Aiming for Mid-Single-Digit Revenue CAGR Over Next Decade Amounting to
JPY5 Trillion( $47 Billion) by FY20301
- Wave 1 Pipeline Portfolio Includes 12 New Molecular Entities Targeted for Launch by FY2024 Representing Best-in-Class/First-in-Class Therapies
Near-Term Late-Development Milestones Expected Across All Wave 1 Programs, Including Approval of a New Drug Application to
U.S. Food and Drug Administrationfor TAK-721 in Eosinophilic Esophagitis, and Regulatory Filings for Dengue Vaccine in Endemic Countries and the EU
- Company Provides New Peak Revenue Estimates for Global Brands Driving Growth Momentum in Mid-Term
The majority of this revenue growth is expected to come from the company’s Wave 1 pipeline, which includes 12 unique New Molecular Entities (NMEs), representing potential best-in-class/first-in-class therapies, and its existing 14 global brands. Of the Wave 1 programs, five have received Breakthrough Therapy designation and three were granted fast track designation by the
“Our vision is to discover and deliver life-transforming treatments guided by our commitment to patients, our people and the planet,” said
During the call, Takeda provided a deep dive into TAK-721, which has the potential to be the first FDA-approved agent for the treatment of eosinophilic esophagitis (EoE), and TAK-003, which is a live attenuated tetravalent vaccine for prevention of dengue disease. In addition, the company highlighted the sustained momentum of global brands such as Entyvio®, and the commercial capabilities that will help to ensure launch success.
Bringing a Highly Innovative Pipeline to Patients for Sustained Growth
Takeda has built a world-class, state-of-the-art R&D engine and has generated a diverse and dynamic pipeline of approximately 40 clinical-stage new molecular entities that is beginning to deliver. All 12 Wave 1 pipeline NMEs have anticipated near-term late-development milestones, pivotal data readouts or pivotal study starts. Takeda has expanded its global capabilities including data insights and analytics, patient services, and evidence generation to enhance commercial excellence for delivering these life-transforming therapies to patients around the world.
Beyond the Wave 1 pipeline, Takeda’s research engine, comprised of 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 pipeline 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.
ABOUT TAK-721 and TAK-003
TAK-721 (budesonide oral suspension)
Takeda’s TAK-721 is a mucoadherent, topical, viscous formulation of budesonide, formulated specifically as an investigational treatment for (EoE). If approved, TAK-721 will be the first FDA-approved treatment for EoE; Takeda plans to use the trade name Eohilia (budesonide oral suspension). To date, it has received both Breakthrough Therapy designation and Orphan Drug designation from the FDA. Its development program is the first and largest EoE Phase 3 clinical trial program in the
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.
To access a replay of today’s Wave 1 Pipeline Market Opportunity Call, including presentation slides with the latest data and updates on TAK-721 and TAK-003, visit https://www.takeda.com/investors/ir-events/.
Takeda plans to host part 2 of the Wave 1 pipeline update on
Takeda 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” 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
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).
2 PTS (Probability of Technical Success) adjusted figures represent Takeda’s base case, i.e. its estimate of revenue based on technical milestones it believes it is probable to achieve.
3 Does not include any potential impacts imposed by the Most Favored Nation Model interim final rule issued by the
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