OSAKA, Japan--(뉴스와이어) 2021년 08월 02일 -- Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) (“Takeda”) today announced financial results for the first quarter of fiscal year 2021 (period ended June 30, 2021). Based on the solid first-quarter results, the Company also confirmed its fiscal year 2021 management guidance and forecast. Fiscal year 2021 remains a year of inflection with Takeda positioned for topline acceleration and continued pipeline progress, including critical regulatory submissions, potential approvals and additional new molecular entities (NMEs) advancing in pivotal studies.
Costa Saroukos, Chief Financial Officer, commented:
“With the Shire integration behind us and continued transformation over the last two years, we’ve pivoted towards accelerating topline growth and investing in R&D to fuel our highly innovative pipeline. Takeda’s first-quarter results demonstrate the continued strength of our 14 global brands and, with the business momentum from this strong start to our fiscal year, we remain on track towards our full-year management guidance.”
“FY2021 is an inflection year for our pipeline as we ramp up strategic R&D investments and the pipeline starts to deliver. We anticipate having five to six Wave 1 pipeline regulatory submissions by the end of this fiscal year, with the potential for five approvals by end of H1 FY2022. The resilience of Takeda’s business model is a testament to our unwavering commitment to serving patients, our people and the planet. We are focused on discovering and delivering life-transforming treatments to people around the world to create and maximize long-term value for society.”
FINANCIAL AND BUSINESS HIGHLIGHTS
Results for Q1 FY2021 Ended June 30, 2021
(To view the table, please visit https://bit.ly/3yo8gik)
Reported Revenue increased +18.4% to 949.6 billion yen ($8.6B); Underlying Core Revenue increased +3.8% vs. FY2020 Q1, driven by the 14 global brands
· Takeda’s 14 global brands, with an aggregate reported revenue of 335.6 billion yen ($3.0B), posted year-over-year underlying revenue growth of +6.8% despite quarterly phasing headwinds for TAKHZYRO and IG. Takeda’s 5 key business areas with 708.0 billion yen ($6.4B) in reported revenue represented 87% of core revenues.
。 GI with 210.5 billion yen ($1.9B) in reported revenue, with underlying revenue growth of +8% spearheaded by gut-selective ENTYVIO.
。Rare Diseases with 155.5 billion yen ($1.4 B) in reported revenue declining -3% on an underlying basis, with HAE growth impacted by phasing, but remains in line with the current plan.
。Plasma Derived Therapy (PDT) Immunology with 107.2 billion yen ($1.0B) in reported revenue declining -2% on an underlying basis, impacted by quarterly phasing of Immunoglobulin products, with full-year outlook unchanged.
。Oncology with 121.4 billion yen ($1.1B) in reported revenue, with underlying revenue growth +9% driven by indication expansion across the portfolio.
。Neuroscience with 113.4 billion yen ($1.0B) in reported revenue, with underlying revenue growth +3% driven by strong rebound of Vyvanse following impact of COVID-19 in the prior year.
 Percentage of sales are based on Core revenue; adjusted to remove JPY 133.0B from sale of Japan diabetes portfolio recorded in revenue
Reported Operating Profit increased 48.6% Underlying Core Operating Profit Margin was 30.5% for Q1
· Reported operating profit increased 48.6% to 248.6 billion yen ($2.2B) compared to FY2020 Q1, driven by a gain on the sale of the diabetes portfolio in Japan, lower purchase price accounting expenses and lower integration costs. These items more than offset a decrease in other operating income due to a one-time gain recorded in FY2020 Q1.
· Underlying core operating profit for the current period declined -2.1% reflecting an increase in R&D investment and is expected to recover to “mid-single digit” growth for the full year.
· Continued progress in debt pre-payment with approximately 242.9 billion yen toward $2.2 billion paid in FY2021 Q1.
Achieved several critical pipeline milestones to date in FY2021
· Moderna’s COVID-19 Vaccine, approved in Japan for adults in May and expanded age indication to adolescents 12+ years old in July, with distribution underway.
· Mobocertinib (TAK-788) filing under review in US, China, and other countries.
· Maribavir’s (TAK-620) filing and acceptance in the US and EU, with FDA granting priority review.
· Orexin (TAK-994) granted Breakthrough Therapy designation by the FDA for Narcolepsy Type 1.
· TAK-999 granted Breakthrough Therapy designation by the FDA for AATD Liver Disease
· Collaboration with Frazier Healthcare Partners to launch HilleVax, Inc., a biopharmaceutical company to develop and commercialize TAK-214, Takeda’s norovirus vaccine candidate.
 AATD = Alpha-1 antitrypsin deficiency
Important recognition in Q1
· Two of Takeda’s facilities in Japan and Ireland were recognized by the International Society for Pharmaceutical Engineering (ISPE) with the 2021 Facility Of the Year Awards for the use of digital and innovative technologies to enhance manufacturing capabilities.
(To view the table, please visit https://bit.ly/3yo8gik)
Key assumptions in FY2021 forecast
Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, underlying revenue growth of its 14 global brands, and accelerated realization of cost synergies, while continuing to invest in R&D.
FY2021 guidance reflects the following key assumptions, including (1) Takeda expects at least one 505(b)2 competitor for subcutaneous VELCADE to launch in the U.S. around mid FY2021; (2) Takeda does not expect to restart sales of Natpara in the U.S. market in FY2021; and (3) FY2021 guidance does not include the impact of any potential further divestitures beyond what has already been disclosed by Takeda.
To date, Takeda has not experienced a material effect on its financial results as a result of the global spread of the novel coronavirus infectious disease (COVID-19). Based on currently available information, Takeda believes that its financial results for FY2021 will not be materially affected by COVID-19 and, accordingly, Takeda's FY2021 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2021, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in an additional impact on Takeda’s business, results of operations or financial condition, as well as result in significant deviations from Takeda’s FY2021 forecast.
For more details on Takeda's Q1 FY2021 results and other financial information, please visit: https://www.takeda.com/investors/financial-results/
More information on Takeda’s Environmental, Social and Governance (ESG) approach and values-based corporate governance can be found in the 2021 Annual Integrated Report for FY2020, which ended March 31, 2021. This report can be accessed on Takeda’s website at: https://air.takeda.com.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TOKYO: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 and regions. For more information, visit https://www.takeda.com.
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Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”). Convenience translations of JPY figures into USD are included for reference and have been calculated at a rate of JPY/USD of 111.05.
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 is posted on Takeda’s investor relations website at https://www.takeda.com/investors/financial-results/
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