OSAKA, Japan--(뉴스와이어)--Takeda (TOKYO:4502/NYSE:TAK) today announced strong financial results for fiscal year 2021 (period ended March 31, 2022), driven by the performance of its growth products, new product launches and strength across its key business areas.

Takeda president and chief executive officer, Christophe Weber, commented: “We are pleased to report another year of strong performance, driven by our growth products. I am energized by the impact we are making for patients and by our continued momentum. We are seeing the potential of our innovative pipeline of approximately 40 clinical stage assets come to life, as demonstrated by the approval and launch of EXKIVITY® and LIVTENCITY™.

Looking ahead, our goal is to continue to grow Takeda into the most trusted, science-driven, digital biopharmaceutical company, and our strong performance against our strategy in FY2021 reinforces my confidence about the path we are on.”

Takeda chief financial officer, Costa Saroukos, commented: “Takeda’s strong FY2021 performance against our management guidance provides a solid foundation for our FY2022 outlook for continued topline growth and robust cash flow generation. This will allow us to allocate capital to maximize value for patients and shareholders as we invest in our R&D engine, new product launches and other growth drivers while continuing to rapidly reduce debt and return cash to shareholders.”

FINANCIAL AND BUSINESS HIGHLIGHTS

Results for FY2021 Ended March 31, 2022

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COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS

- Gastroenterology (GI), with 875.7 billion yen in reported revenue, grew +7% on an underlying basis driven by gut-selective ENTYVIO® and anti-acid therapy TAKECAB®. Following a review of assumptions regarding ENTYVIO biosimilars, Takeda is no longer expecting entry of biosimilars upon loss of data exclusivity.

- Rare Diseases, with 611.2 billion yen in reported revenue, declined -1% on an underlying basis, impacted by a decline in line with expectations in Rare Hematology due to intensified competition. Hereditary Angioedema (HAE) had underlying growth of +4% driven by the strong growth of global market leader TAKHZYRO®, which continued its geographic expansion with approval in Japan in March 2022. Post-transplant antiviral infection treatment LIVTENCITY, which launched in the U.S. in December 2021, has been well received by U.S. transplant centers. Additionally, in a recent exploratory data analysis LIVTENCITY showed reductions in hospitalization rates and length of hospital stay.

- Plasma Derived Therapy (PDT) Immunology, with 507.0 billion yen in reported revenue, delivered exceptional growth of +14% on an underlying basis. This was driven by continued strong growing global demand for our Immunoglobulin portfolio and increasing demand for FLEXBUMIN® in China and the U.S., both enabled by improved supply. FY2021 plasma donation volume grew 16% compared to COVID-19-impacted FY2020 and was up 3% over pre-pandemic levels.

- Oncology, with 468.7 billion yen in reported revenue, grew +8% on an underlying basis driven by increased market penetration and strong demand increases in Growth and Emerging Markets, particularly China. Non-small cell lung cancer (NSCLC) treatment EXKIVITY, which launched in the U.S. in September 2021, continued its global expansion with recent conditional approval in the U.K.

- Neuroscience, with 482.3 billion yen in reported revenue, grew +10% on an underlying basis driven by increased demand for VYVANSE® following the impact of COVID-19 in FY2020.

PRODUCT HIGHLIGHTS

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PIPELINE UPDATE

Takeda strives to advance a steady stream of potential first-in-class or best-in-class therapies through a pipeline of approximately 40 molecules in clinical development - 90 percent of which did not exist six years ago. Leveraging its development strength, robust partnerships and innovative research engine, Takeda is focused on providing transformative treatments for targeted populations with high unmet needs across its core therapeutic areas.

In FY2021, Takeda further demonstrated its ability to bring new therapies to patients, receiving its highest total number of approvals in a fiscal year across Japan (4 NMEs), China (3 NMEs), the U.S. (2 NMEs), and Europe (1 NME) and leading the industry in drug approvals in Japan in calendar year 2021. Significant pipeline updates in Q4 FY2021 and since include:

· Approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for NUVAXOVID® Intramuscular Injection, a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. (Press Release)

· VONVENDI® received approval from the U.S. FDA for adult patients living with severe type 3 von Willebrand Disease (VWD), making it the first and only treatment approved for routine prophylaxis to reduce the frequency of bleeding episodes in adults living with severe type 3 VWD receiving on-demand therapy. (Press Release)

· TAKHZYRO was approved by Japan’s MHLW for adult and pediatric patients 12 years of age and older for prophylaxis against acute attacks of hereditary angioedema (HAE) (Press Release). In February, the U.S. FDA approved a single-dose prefilled syringe injection for adult and pediatric patients 12 years and older (Press Release). Studies investigating TAKHZYRO for pediatric patients aged 2 to up to 12 years of age are ongoing and global regulatory filings for this patient population are planned to begin in FY2022. (Press Release)

· ALOFISEL® showed clinical remission rate at six-months in the real-world INSPIRE study interim analysis consistent with the pivotal clinical ADMIRE-CD Study. ALOFISEL offers a potential cell-mediated closure option for patients with complex Crohn’s perianal fistulas who have shown an inadequate response to at least one conventional or biologic therapy. (Press Release)

· First Phase 2 study of TAK-755 was completed. TAK-755 is the first and only ADAMTS-13 replacement therapy in clinical development to address congenital thrombotic thrombocytopenic purpura (cTTP) and immune mediated thrombotic thrombocytopenic purpura (iTTP), life-threatening thrombotic disorders caused by ADAMTS-13 deficiency. Takeda expects Phase 3 data for TAK-755 in cTTP in FY2022 and potential filing for approval in FY2022.

· After years of extensive regulatory discussions, Takeda has decided to discontinue development of TAK-609 as data are not sufficient for filing. Takeda remains committed to developing therapies for Hunter syndrome and other lysosomal storage disorders.

· Regulatory filings in Europe and endemic countries are ongoing for TAK-003, Takeda’s dengue vaccine candidate, and U.S. regulatory filings are planned for later this year. (Press Release). Additional clinical data (the DEN-301 4.5 year analysis) will be presented at a scientific congress in June 2022.

· Expanded collaboration with JCR Pharmaceuticals to develop gene therapies that apply JCR’s J-Brain Cargo® blood-brain barrier (BBB) penetration technology for lysosomal storage disorders​.

· Entered into a strategic collaboration and license agreement with Evozyne to develop proteins for gene therapies for genetic disorders within the inborn errors of metabolism and lysosomal storage disease areas of research.

FY2022 GUIDANCE

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Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, discipline in operating expenses, and FX favorability.

In FY2022, Takeda expects continued revenue growth driven by an acceleration of our Growth and Launch Products, alongside FX tailwinds, to fully offset the impact from loss of exclusivity of VELCADE® in the U.S. and the non-recurrence of 133.0 billion JPY from the sale of a diabetes portfolio in Japan recorded in FY2021. Core operating profit is expected to reach 1.1 trillion JPY, mainly driven by business momentum.

Key Assumptions in FY2022 Forecast and Management Guidance

Based on currently available information, Takeda expects that its financial results for FY2022 will not be materially affected by COVID-19 or the crisis in Ukraine and Russia and, accordingly, Takeda’s FY2022 reported forecast and management guidance reflect this expectation.

The FY2022 reported forecast and management guidance include approximately 50.0 billion JPY revenue contribution from COVID-19 vaccines.

For more details on Takeda's FY2021 results and other financial information, please visit: https://www.takeda.com/investors/financial-results/.

About Takeda

Takeda 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 and regions. For more information, visit https://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 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.

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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, including global health care reforms; 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, 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/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.

Financial information and Certain Non-IFRS Financial 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 non-IFRS financial measures not presented in accordance with IFRS, such as Underlying Revenue, Core Operating Profit, Underlying Core Operating Profit, Core Net Profit, Underlying Core EPS, Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and CER Growth. 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, which are on slides 35-38, 49-57, and 61 of Takeda's full-year FY2021 investor presentation (available at takeda.com/investors/financial-results).

Exchange Rates

Throughout this press release, certain amounts presented in Japanese yen have been translated to US dollars solely for the convenience of the reader at an exchange rate of 1USD = 121.44 JPY, the Noon Buying Rate certified by the Federal Reserve Bank of New York on March 31, 2022. The rate and methodologies used for these convenience translations differ from the currency exchange rates and translation methodologies under IFRS used for the preparation of Takeda’s consolidated financial statements. These translations should not be construed as a representation that the relevant Japanese yen amounts could be converted into U.S. dollars at this or any other rate.

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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