Company: DVAX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001628280-25-049536
Chunk: 438

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 2
Chunk 438
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 such industry-specific pharmaceutical tariffs will be ultimately imposed by the U.S. government. 

We rely on our facility in Düsseldorf, Germany and third parties to perform the multiple processes involved in manufacturing hepatitis B surface antigen for use in HEPLISAV-B, the manufacture and combination of the oligonucleotide with the antigens, and formulation, fill and finish. While we cannot at this time predict the ultimate impact of the proposed tariffs, or if they would apply to transactions between a parent company and its foreign subsidiary, we anticipate that that our margins could be adversely affected beginning as early as fiscal 2026, depending on the ultimate scope and duration of tariffs imposed. However, given the volatility and uncertainty regarding the scope and duration of such tariffs and other aspects of U.S. and foreign government trade policies, the ultimate impact on our operations and financial results remains uncertain and could be significant.  

Such tariffs may result in additional costs on our business, including costs with respect to the items mentioned above upon which our business depends and may generally increase our manufacturing costs. In addition, such tariffs may increase our supply chain complexity and could also potentially disrupt our existing supply chain. Moreover, other governments have imposed and may continue to impose retaliatory tariffs, trade restrictions or trade barriers impacting HEPLISAV-B, which could impose additional costs and complexity on our business, including with respect to our planned commercialization of HEPLISAV-B.

Further, the continued threats of new or increased tariffs, sanctions, trade restrictions and trade barriers as well as ongoing changes in U.S. and foreign government trade policies, including potential modifications to existing international trade agreements, have had and may continue to have a generally disruptive impact on the global economy and, therefore, could negatively impact revenues from sales of HEPLISAV-B. Given the volatility and uncertainty regarding the scope and duration of such tariffs and other aspects of U.S. and foreign government trade policies, the ultimate impact on our operations and financial results is uncertain and could be significant in the future. In any event, further trade restrictions and export regulations, or new or increased tariffs, including further retaliatory measures, could increase our supply chain complexity and our manufacturing costs, decrease our gross margins, reduce the competitiveness of HEPLISAV-B, or restrict our ability to sell HEPLISAV-B in the EU or in other international markets where we may obtain approval of HEPLISAV-B, or restrict or increase our costs to purchase necessary equipment and supplies. Any of these factors could have a material adverse effect on our financial results