Company: DVAX
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001029142-25-000071
Chunk: 301

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 8
Chunk 301
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 March 31, 2025, compared to the three months ended March 31, 2024. Approximately $10.1 million of the increase in product revenue was due to higher volume, largely driven by continued improvement in market share, particularly in the integrated delivery networks and retail segments, and growth in the U.S. hepatitis-B vaccine market. Increases in net sales price contributed approximately $8.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. There were no non-U.S. sales for the three months ended March 31, 2025, compared to approximately $1.1 million for the three months ended March 31, 2024.

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. 

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

 Three Months EndedMarch 31,Increase from 2024 to 2025Cost of Sales - Product20252024$%HEPLISAV-B$13,769 $10,966 $2,803 26 %Total cost of sales - product$13,769 $10,966 $2,803 26 %

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Table of Contents

HEPLISAV-B cost of sales-product increased by $2.8 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The increase was primarily due to the growth in HEPLISAV-B sales volume, coupled with inventory write-offs recorded related to yield loss during the production process, partially offset by lower per-unit manufacturing costs as a result of previous manufacturing process improvements.

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,