Company: TAK
Filing Date: 2025-06-25
Form Type: 20-F
Source: 0001395064-25-000095
Chunk: 64

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-06-25
Form: 20-F
Item: Item 4
Chunk 64
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 to operational and quality issues, production capacity and single sourcing among others. For critical and strategic products, we have decided to make significant long-term capital investments to build internal manufacturing capacity and secure dual sources to reduce the dependency on outsourced manufacturing relationships with third-party suppliers.

Manufacturing

The manufacturing of our products is highly regulated by governmental health authorities around the world, including the U. S. FDA, EMA, Japan’s Pharmaceuticals and Medical Devices Agency (“ PMDA”) and NMPA. Furthermore, many of our products involve technically complex manufacturing processes or may require a supply of highly specialized raw materials.

We manufacture a certain number of our products in our own facilities within our global manufacturing network. In addition, we source certain other products from third-party contract manufacturers. We have a n etwork of more than 100 contract manufacturers which provide varying services such as the manufacture of active pharmaceutical ingredients, bulk drug product, aseptic fill finish and final packaging. In cases where we utilize contract manufacturers, we are often dual sourced with an internal manufacturing site. In cases where we are not dual sourced, we manage the risks associated with the reliance on a single source of production by carrying additional inventories.

Sales and Marketing

Our primary sales and marketing activities are organized around regional business units and select therapeutic area business units focused on the U. S., Japan, Europe and Canada, China and Growth and Emerging Markets. These business units make focused investments that support the growth potential of our portfolios in each market.

The U. S. is the largest pharmaceutical market in the world and is also Takeda’s largest region by revenue. The United States Business Unit (“ USBU”) is focused on the successful launch of a subcutaneous administration of ENTYVIO( ENTYVIOPen), approved for ulcerative colitis in September 2023 and Crohn’s disease in April 2024, EOHILIA, approved in February 2024, and the expanded indications for HYQVIA andGAMMAGARD LIQUID in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) approved in January 2024. In addition, core promoted products such as TRINTELLIX, GATTEX andTAKHZYRO will contribute to the growth as being supported by significant investment in the marketing and sales force promotion.

The Japan Pharma Business Unit (“ JPBU”) is focused on retaining Takeda’s position as one of the leading pharmaceutical companies in our home market of Japan. Although we continue to