On May 11, 2022 Takeda (TOKYO:4502/NYSE:TAK) reported 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 (Press release, Takeda, MAY 11, 2022, View Source [SID1234614239]).
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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."
(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source
(b) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda’s core operations, such as, to the extent applicable for each line item, amortization and impairment of intangible assets, other operating income and expenses, certain JV-related accounting adjustments, non-recurring items, purchase accounting effects and transaction related costs.
(c) Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.
(d) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment ("PP&E"), intangible assets and investments as well as any other cash that is not available to Takeda’s immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.
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.
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
CER: Constant Exchange Rate
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.