Company: DVAX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001628280-25-049536
Chunk: 424

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 2
Chunk 424
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 of other competing approved products;

•the potential advantages of the product over existing and future treatment methods;

•the relative convenience and ease of administration of the product;

•the strength of our sales, marketing and distribution efforts;

•the price and cost-effectiveness of the product; and

•third-party coverage and adequate reimbursement and the willingness of patients to pay out-of-pocket in the absence of sufficient reimbursement by third-party payors. 

Market acceptance of vaccines has been negatively impacted in recent years due to increasing vaccine skepticism and disinformation. The potential for individuals with anti-vaccine views to hold governmental and other roles of influence and for disinformation campaigns to negatively impact potential market acceptance for HEPLISAV-B and any of our future approved products may slow our sales growth and weaken our market prospects.

The FDA or other regulatory authorities could limit the labeling indication for which our product candidates may be marketed or could otherwise limit marketing efforts for our products. If we are unable to achieve approval or successfully market any of our products or product candidates, or marketing efforts are restricted by regulatory limits, our ability to generate revenue could be significantly impaired.

45

As we continue to grow as a commercial organization and enter into supply agreements with customers, those supply agreements will have obligations to deliver product that we are in part reliant upon third parties to manufacture on our behalf.

As our commercial business begins to expand in connection with commercial sales of HEPLISAV-B or CpG 1018 adjuvant, as applicable, the contracts we enter into with our customers will generally carry delivery obligations that require us to deliver product in certain quantities and meet certain quality thresholds, among other things, all within specified timeframes. If, for any reason, whether due to reliance on third-party manufacturers or otherwise, we are unable to deliver timely, compliant products to our customers in quantities that meet our contractual obligations, we could be subject to lost revenue, contractual penalties, suits for damages, harm to our reputation or other problems that could materially and adversely affect our business. To the extent we add new products in the future, these risks could be exacerbated by the added complexity of managing multiple product lines.

We face uncertainty regarding coverage, pricing and reimbursement and the practices of third-party payors, which may make it difficult or impossible to sell certain of our products or product candidates on commercially reasonable terms.

In both domestic and foreign markets, our ability to achieve profitability will depend in part on the negotiation of a favorable price, as well as the availability of coverage and adequate reimbursement, from third-party payors, in