Osaka - Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) ('Takeda') today announced financial results for the first quarter of fiscal year 2020 (quarter ended June 30, 2020).
Based on the first quarter performance, the company confirms management guidance, and raises reported operating profit and reported net profit for the full year. The company also announced recent updates to its R&D pipeline and highlighted its R&D momentum with seven potential New Drug Application filings planned for the next 12 months.
Underlying revenue growth was 0.9% year on year. Takeda's five key business areas, which represent 83% of revenue, delivered underlying revenue growth of 6%, and its 14 global brands, with reported revenue of JPY 308.0 billion in aggregate, posted 20% underlying revenue growth
Reported revenue was JPY 801.9 billion, with the impact of foreign currency and divestitures resulting in a year-on-year decline of 5.6%
Core operating profit[1] was JPY 280.9 billion, with the core operating profit margin at 35.0% driven by cost synergies and OPEX efficiencies
Reported operating profit increased significantly, up 270% to JPY 167.3 billion, driven by lower purchase accounting and integration-related expenses; reported net profit increased to JPY 82.5 billion from JPY 7.0 billion a year earlier[2]
Reported operating cash flow increased by 21% to JPY 145.9 billion; free cash flow of JPY 146.3 billion represents a 64% increase over the prior year
Robust cash generation enabled further deleveraging to 3.7x net debt/adjusted EBITDA, demonstrating strong progress from 4.7x at the end of March 2019
Takeda increased its forecast for FY2020 reported operating profit to JPY 395 billion from JPY 355 billion, reported net profit to JPY 92 billion from JPY 60 billion, and for reported EPS to JPY 59 from JPY 39, to reflect a net gain from one-time items recognized in the first quarter
Takeda Chief Financial Officer Costa Saroukos commented: 'Takeda delivered solid first quarter results even during a period of great challenges for our employees, for patients, and for the communities we serve around the world. The performance of our global brands and key business areas demonstrates the quality of our product portfolio and resilient demand for medicines targeting severe chronic or life-threatening conditions. Among the Q1 highlights, ENTYVIO delivered exceptional underlying growth of 26%, TAKHZYRO is ramping up very well with underlying growth of 66%, and Immunoglobulin delivered strong underlying growth of 30%.
'Momentum is also building in our R&D pipeline, with seven potential Wave 1 New Drug Application filings targeted over the next 12 months, as well as further expansions of our global brands. In addition, we are making progress in various efforts to develop potential therapies for patients at risk from serious complications of COVID-19.
'Takeda has sustained the financial strength which underpins our success, with underlying revenue growth and strong underlying core operating profit growth, margins and cash flow. We continue to make steady progress toward our deleveraging and divestiture targets, and remain confident in Takeda's growth momentum for the full year and in opportunities to accelerate growth in the medium term.'
Pipeline Update: Momentum in Our Dynamic R&D Growth Engine
Takeda has built a world-class R&D engine leveraging our internal research capabilities, while also actively engaging with innovative ecosystems around the world to translate science into highly innovative medicines. The main drivers for targeted new product launches are 12 unique New Molecular Entities (NMEs) in Wave 1, which represent several potential best-in-class / first-in-class therapies targeted for launch by FY2024 with aggregate potential peak sales of more than $10 billion.
With seven potential Wave 1 NME filings in the next 12 months, as well as additional expansions of our global brands, the momentum of our R&D growth engine is increasing.
In Oncology, pevonedistat was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat could be the first novel therapy in over a decade for HR-MDS and patients with acute myeloid leukemia for whom standard treatments are not appropriate.
We are excited about the transformative medium-term potential of a number of our major R&D programs, including: In Oncology, TAK-007 for the treatment of hematologic malignancies on an outpatient basis, with encouraging Phase 1/2 data and cohort expansion ongoing for a pivotal study planned for next year and potential approval in FY2023
In Neuroscience, the first patient has been enrolled in a Phase 2 trial of TAK-994 for the treatment of narcolepsy type 1, with potential approval in FY2024
Contact:
Takashi Okubo
Tel: +81-(0)3-3278-2306
Email: takashi.okubo@takeda.com
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 bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, 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.
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