Company: DVAX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001628280-25-049536
Chunk: 399

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 2
Chunk 399
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 summary of our cost of sales - product (in thousands, except for percentages):

 Three Months EndedSeptember 30,Increase from 2024 to 2025Nine Months EndedSeptember 30,Increase from 2024 to 2025Cost of Sales - Product20252024$%20252024$%HEPLISAV-B$14,403 $13,084 $1,319 10 %$42,207 $36,035 $6,172 17 %Total cost of sales - product$14,403 $13,084 $1,319 10 %$42,207 $36,035 $6,172 17 %

HEPLISAV-B cost of sales-product increased by $1.3 million and $6.2 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024. The increase was primarily due to the growth in HEPLISAV-B sales volume. Cost of sales-product for the nine months ended September 30, 2025, also included approximately $3.1 million primarily related to yield loss during the production process, compared to approximately $1.3 million during the nine months ended September 30, 2024, related to one manufacturing batch that did not meet approved release specifications.

Research and Development Expenses 

Research and development expenses are tracked on a program-by-program basis and consist primarily of costs incurred for the continued research and development of HEPLISAV-B and CpG 1018 adjuvant, clinical product candidates, and preclinical studies. These expenses include, but are not limited to, compensation and related personnel costs (which include benefits, recruitment and travel costs), expenses incurred under agreements with contract research organizations, contract manufacturing organizations and service providers that assist in conducting clinical studies, and costs associated with our preclinical activities, including engineering activities at our manufacturing facility in Düsseldorf related to functional improvements of our product and process advances, development activities and regulatory operations. We do not allocate stock-based compensation or facility expenses to specific programs because these costs are deployed across multiple programs.

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The following is a summary of our research and development expenses (in thousands, except for percentages):

 Three Months EndedSeptember 30,Increase (Decrease) from 2024 to 2025Nine Months EndedSeptember 30,Increase (Decrease) from 2024 to 2025Program Expenses:20252024$%202