Company: TAK
Filing Date: 2025-06-25
Form Type: 20-F
Source: 0001395064-25-000095
Chunk: 90

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-06-25
Form: 20-F
Item: Item 5
Chunk 90
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 generic competitor approved in June 2023), which led to declines in sales for both products in the relevant jurisdictions. Sales of VYVANSE decreased from JPY 423.2 billion in the fiscal year ended March 31, 2024 toJPY 350.6 billion in the fiscal year ended March 31, 2025; sales of AZILVA decreased from JPY 33.6 billion toJPY 11.8 billion during the same period. We expect these decreasing trends for both of these products to continue in the fiscal year ending March 31, 2026.

In certain cases, generic competitors may successfully challenge the validity of patents, or the manufacturer may decide that the benefits of prematurely launching the generic drug “at risk” outweigh the costs of defending infringement litigation. In situations where the validity of patents or the value of the protection is challenged, we may record impairment losses with respect to the relevant intangible property.

Development and Commercialization of New Products and Expansion of Existing Products

The development and commercialization of new biopharmaceutical products is key to our business, as is the expansion of existing products to additional indications and/or geographic markets, particularly as we seek to grow our revenue and to offset the effect of losses of exclusivity. The process to achieve these goals is lengthy and expensive and requires us to incur significant research and development costs, which are recorded as a component of operating expenses in our consolidated statements of income. See “ Item 4. Information on the Company - B. Business Overview - Research and Development” for information about our research and development efforts, and Note 3 to our audited consolidated financial statements contained in elsewhere in this annual report for discussions of our accounting policies regarding research and development expenses and intangible assets relating to products (including amortization and impairment thereof).

Takeda refers to certain products in its portfolio as “ Growth & Launch Products.” Although, particularly for products early in their life cycle, most of these products’ contribution to consolidated revenue is limited, Takeda’s management monitors these products in particular as key drivers of future growth, and believes that information on these products is useful to investors to understand where Takeda expects growth to arise in the future. The specific products that make up this group may vary over time, and products may be added or removed to this group depending on, among other things, the results of clinical trials and regulatory approvals being obtained. During the fiscal year ended March 31, 2025, Takeda classified the following as