Company: DAWN
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001193125-25-264649
Chunk: 68

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-11-04
Form: 10-Q
Item: Item 3
Chunk 68
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 current third-party manufacturers cannot perform as agreed, we may be required to replace such manufacturers and we may be unable to replace them on a timely basis or at all. Our current and anticipated future dependence upon others for the manufacture of OJEMDA or our product candidates may adversely affect our future profit margins and our ability to commercialize any products that obtain marketing authorization on a timely and competitive basis. We rely on a limited number of suppliers for raw materials and any disruptions arising from our sole suppliers could result in delays in our clinical trials or otherwise adversely affect our business and results of operations.We rely on a limited number of suppliers, some of whom are our sole source for certain materials, and some of whom are based in foreign jurisdictions. Our small number of suppliers involves a number of additional risks, including risks related to supplier capacity constraints, component availability, price increases, timely delivery, component quality, failure of a key supplier to remain in business and adjust to market conditions, including inflation and changes in interest rates, changes in domestic and foreign currency rates, significant political, trade or regulatory developments, including the implementation of tariffs by the United States, China, and other governments, natural disasters, fire, regional geopolitical conflicts, acts of terrorism, pandemics, or other catastrophic events. Further, 

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in the case of materials for which we have a sole supplier, even if we are able to replace any raw materials or other materials with an alternative, such alternatives may cost more, result in lower yields or not be as suitable for our purposes. In addition, some of the materials that we use to manufacture OJEMDA and our product candidates are complex materials, which may be more difficult to substitute. Therefore, any disruptions arising from our sole suppliers could result in delays and additional regulatory submissions, which may adversely affect our business and results of operations.The Company is sensitive to increased U.S. tariffs and other trade restrictions, including tariffs specifically on imports from China and tariffs on imports of pharmaceutical products from other jurisdictions. If such tariffs are expanded in scope, increased, or become permanent, the Company could experience higher costs on imported raw materials and product intermediates, which may compress margins. Because the timing, scope and enforceability of such tariffs are uncertain, we may not be able to fully predict or mitigate their impacts. Increased tariffs and other trade restrictions on China could increase annual API costs for OJEMDA. Although the effect of the more recently announced worldwide product-specific Pharmaceutical tariffs is only beginning to materialize, management expects that such measures could further increase costs.To mitigate