Dynavax Technologies (DVAX -1.43%), a biotechnology company focused on vaccines, released its results for the second quarter of 2025 on August 7, 2025. The company posted GAAP revenue of $95.4 million, sharply ahead of analyst expectations of $86.7 million, and GAAP diluted earnings per share (EPS) of $0.14 versus a $0.10 consensus estimate. This result marks significant year-over-year growth, with both GAAP revenue and earnings well above the same period in 2024. The quarter stood out for record sales of HEPLISAV-B, continued margin strength, and progress on multiple vaccine candidates. Overall, Dynavax delivered a strong quarter that beat internal and external forecasts, raised key product guidance, and continued to invest in its research pipeline.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS, Diluted | $0.14 | $0.11 | $0.08 | 75.0% |
| Revenue | $95.4 million | $86.66 million | $73.8 million | 29.3% |
| Adjusted EBITDA | $37.3 million | $20.5 million | 81.9% | |
| HEPLISAV-B Net Product Revenue | $91.9 million | $70.2 million | 30.8% | |
| R&D Expenses | $16.6 million | $15.0 million | 10.7% |
Source: Analyst estimates provided by FactSet. Management expectations based on management's guidance, as provided in Q1 2025 earnings report.
Company Overview and Business Focus
Dynavax Technologies is a biopharmaceutical company specializing in the development and commercialization of vaccines for infectious diseases. Its standout product is HEPLISAV-B, a two-dose adult hepatitis B vaccine approved in the U.S. European Union, and United Kingdom. The vaccine's two-dose schedule contrasts with traditional three-dose regimens, providing faster and stronger immune protection.
In recent years, Dynavax has zeroed in on expanding HEPLISAV-B's market share, advancing a vaccine pipeline built on its proprietary CpG 1018 adjuvant, and forging partnerships for both commercialization and research. The core of its business strategy centers on commercial execution for HEPLISAV-B, clinical development for new vaccine candidates such as shingles and plague, and building collaborative alliances to support growth and diversification.
Quarter Review: Results, Drivers, and Key Developments
The company delivered a strong quarter, with total GAAP revenue up 29% compared to the prior year. GAAP revenue exceeded analyst expectations by $8.7 million. This profitability came alongside record net product revenue from HEPLISAV-B, which accounted for nearly all product sales. The vaccine's U.S. market share reached approximately 45%, up from about 42% a year earlier. These gains align with management’s longer-term goal of achieving at least 60% market share by 2030.
Market share gains resulted from growing adoption in the retail pharmacy channel and continued momentum following updated vaccination recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP), which advocated universal adult hepatitis B immunization. These gains were observed in the U.S. adult hepatitis B vaccine market after the ACIP's universal recommendation in 2022, with continued adoption and momentum reported through the first half of 2025. Management attributed the robust performance to retail expansion, increased demand, and ongoing execution of targeted strategies within the adult vaccine market.
Dynavax also reported significant progress on its clinical pipeline. The shingles vaccine candidate, Z-1018, is a protein subunit vaccine combined with the company’s proprietary CpG 1018 adjuvant. A Phase 1/2 trial among adults ages 50–69 finished enrollment, with a key top-line data readout set for August 2025. Additional development programs include a plague vaccine in partnership with the U.S. Department of Defense and early-stage efforts targeting pandemic influenza (H5N1) and Lyme disease. Notably, the plague vaccine program benefits from a $30 million collaboration and is scheduled to advance to Phase 2 trials in the second half of 2025.
Gross margin for HEPLISAV-B is projected at approximately 80% for full year 2025, according to company guidance. Adjusted EBITDA (non-GAAP) improved to $37.3 million in the second quarter of 2025, compared to $20.5 million in the same period of 2024. The company ended the quarter with $613.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025, down from $713.8 million as of December 31, 2024. This decline reflected the completion of a $200 million share repurchase program as of June 30, 2025. Operating expenses increased, with research and development (R&D) spending up about 10.7% in the second quarter of 2025 compared to the same period in 2024, due to investments in new and ongoing studies. Selling, general and administrative (SG&A) expenses rose 20.9% in the second quarter of 2025 compared to the same period in 2024, partly reflecting one-time costs tied to a proxy contest.
From a regulatory perspective, Dynavax continued to work actively with agencies such as the U.S. Food and Drug Administration (FDA) to support future label expansions for HEPLISAV-B, including use in adults on hemodialysis. In the first quarter of 2025, Dynavax received feedback from the FDA that its proposed patient database may be acceptable for the observational retrospective cohort study, and the company is engaging with the FDA to finalize the study protocol. Progress also continued on pipeline programs funded through government and other strategic collaborators.
In terms of external context, Dynavax’s HEPLISAV-B faces competitors from larger pharmaceutical players such as GSK and Merck. However, having the only two-dose adult hepatitis B vaccine provides the company a significant differentiating feature. The CpG 1018 adjuvant also underpins Dynavax’s future growth prospects as it advances into new vaccine markets.
Looking Ahead: Guidance and Risks
For the rest of fiscal 2025, management refined full-year guidance for HEPLISAV-B net product revenue to a range of $315–$325 million. This raised the lower bound of Dynavax's full-year 2025 HEPLISAV-B net product revenue guidance to $315 million (from the prior range of $305 to $325 million). Management also reiterated a target of at least $75 million in adjusted EBITDA (non-GAAP) for the full year 2025.
Key issues warranting investor attention include the upcoming data readout for the shingles vaccine candidate in August 2025, when Dynavax expects to report top-line immunogenicity and safety data from Part 1 of its Phase 1/2 clinical trial. This result could shape future pipeline and commercial opportunities. Investors should also monitor expense trends, as R&D and SG&A costs are increasing to support the pipeline and broader corporate initiatives, with R&D expenses rising to $16.6 million and SG&A expenses increasing to $50.4 million in the second quarter of 2025 from $15.0 million and $41.7 million, respectively, in the same period of 2024. Additionally, Dynavax’s cash reserves remained strong at $613.7 million as of June 30, 2025, but declined from $713.8 million at December 31, 2024, due to the share buyback program and ongoing development spending.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
