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Takeda's Pipeline Has Potential to Contribute Significantly to Revenue Growth Over Next Decade

TAK | December 8, 2020

Company Aiming for Mid-Single-Digit Revenue CAGR Over Next Decade Amounting to JPY5 Trillion ($47 Billion) by FY2030 1
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 Administration for 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

As part of its Wave 1 Pipeline Market Opportunity Call, Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) provided an update on its pipeline portfolio, which has the potential to contribute significantly to revenue growth for the company over the next decade. The company also shared its PTS adjusted 2 view for FY2019-FY2030 revenue CAGR (low single-digit), as well as its goal for FY2019-FY2030 revenue CAGR (mid-single-digit), amounting to JPY5 trillion ($47 billion) by FY2030. 3

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 U.S. Food and Drug Administration (FDA). In addition, one program received designation under the SAKIGAKE Designation System by the Japanese Ministry of Health, Labour and Welfare and another program was the first breakthrough designation granted by the China Food and Drug Administration to a multinational biopharmaceutical company.

“Our vision is to discover and deliver life-transforming treatments guided by our commitment to patients, our people and the planet,” said Christophe Weber, Takeda president and chief executive officer. “Our Wave 1 pipeline is reflective of the high bar we have set to focus solely on finding treatments, preventions and cures for targeted populations with high unmet medical needs, and bringing them to patients around the world.”

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 U.S. to report results, and includes the pivotal Phase 3 trials ORBIT1 and ORBIT2 which investigated the safety and efficacy of TAK-721 in adolescent and adult patients (11 to 55 years of age) with EoE. Breakthrough Therapy designation and Orphan Drug designation do not guarantee approval or commercial availability.

TAK-003
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 April 6, 2021 (date subject to change). This will include a deep dive into TAK-925/994, maribavir and an update on oncology assets.

ABOUT TAKEDA PHARMACEUTICAL COMPANY LIMITED

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com .

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 Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; 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, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); 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/reports/sec-filings/ 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.

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.

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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 U.S. Centers for Medicare & Medicaid Services (CMS) on November 20, 2020, which are currently being assessed.