Company: DVAX
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001029142-25-000117
Chunk: 299

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 8
Chunk 299
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5, compared to approximately $1.2 million and $2.3 million related to non-U.S. sales for the three and six months ended June 30, 2024, respectively. We do not currently anticipate revenue from non-U.S. sales in the near future.

Cost of Sales – Product

Cost of sales - product consists primarily of raw materials, certain fill, finish and overhead costs and any inventory adjustment charges for HEPLISAV-B. 

31

The following is a summary of our cost of sales - product (in thousands, except for percentages):

 Three Months EndedJune 30,Increase from 2024 to 2025Six Months EndedJune 30,Increase from 2024 to 2025Cost of Sales - Product20252024$%20252024$%HEPLISAV-B$14,035 $11,985 $2,050 17 %$27,804 $22,952 $4,852 21 %Total cost of sales - product$14,035 $11,985 $2,050 17 %$27,804 $22,952 $4,852 21 %

HEPLISAV-B cost of sales-product increased by $2.1 million and $4.9 million for the three and six months ended June 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 six months ended June 30, 2025, also included approximately $3.4 million primarily related to yield loss during the production process, compared to approximately $1.3 million during the six months ended June 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