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Introduction & Market Context
Dynavax Technologies Corporation (NASDAQ:DVAX) reported strong third-quarter results for 2025, highlighted by continued growth of its flagship hepatitis B vaccine HEPLISAV-B and significant advancements in its diversified vaccine pipeline. The company’s November 2025 earnings presentation revealed robust financial performance, with total revenue reaching $94.9 million, an 18% increase compared to the same period last year.
The positive results prompted a 2.49% rise in Dynavax’s stock price in aftermarket trading, closing at $10.07. The company continues to strengthen its position in the U.S. adult hepatitis B vaccine market while making strategic investments in its pipeline, particularly its promising shingles vaccine candidate.
Quarterly Performance Highlights
HEPLISAV-B remained the primary growth driver for Dynavax, with net product revenue reaching $90 million in Q3 2025, representing a 13% year-over-year increase from $79 million in Q3 2024. The vaccine’s total U.S. market share climbed to 46% at quarter-end, up from 44% in the same period last year.
As shown in the following chart detailing HEPLISAV-B’s revenue growth trajectory, the vaccine has demonstrated impressive performance with a 65% CAGR since 2020:
Particularly notable is HEPLISAV-B’s dominant position in the retail pharmacy segment, where it has captured 63% market share. The vaccine also holds strong positions in dialysis centers (64%) and integrated delivery networks (50%), demonstrating broad market acceptance across healthcare settings.
The company expects the U.S. adult hepatitis B vaccine market to exceed $900 million by 2030, with HEPLISAV-B projected to capture at least 60% of this expanding market. This growth is primarily driven by expansion in the retail pharmacy segment, which is expected to represent 50% of the total market by 2030.
Strategic Initiatives
Dynavax’s strategic focus extends beyond HEPLISAV-B to a diversified vaccine pipeline leveraging its proprietary CpG 1018 adjuvant technology. The most advanced program in development is the company’s shingles vaccine candidate, which showed promising results in Phase 1/2 clinical trials.
The shingles vaccine program demonstrated comparable immunogenicity to the current market leader, Shingrix, while exhibiting a more favorable tolerability profile. As illustrated in the following immunogenicity results, Dynavax’s Z-1018 candidate achieved similar immune responses to Shingrix:
Importantly, the tolerability data revealed significantly lower rates of moderate to severe post-injection reactions compared to Shingrix. Local reactions were reported in only 12.5% of participants receiving Z-1018 with alum, compared to 52.6% for Shingrix. Similarly, systemic reactions were observed in 27.5% of Z-1018 with alum recipients versus 63.2% for Shingrix.
Another significant strategic development is Dynavax’s exclusive licensing agreement for Vaxart’s oral COVID-19 vaccine program. The company invested $25 million upfront plus a $5 million equity stake in Vaxart to secure worldwide rights to this potentially differentiated vaccine candidate, which is currently in Phase 2b clinical trials with efficacy data expected in late 2026.
The oral COVID-19 vaccine aims to address several limitations of current injectable vaccines, including the potential for improved mucosal immunity, reduced transmission, and greater accessibility through its needle-free, thermostable formulation.
Detailed Financial Analysis
Dynavax reported strong financial results for Q3 2025, with total revenue of $94.9 million representing an 18% increase from $80.6 million in Q3 2024. GAAP net income reached $26.9 million, up from $17.6 million in the same period last year.
The company maintained a solid balance sheet with approximately $648 million in cash, cash equivalents, and marketable securities as of September 30, 2025. This strong cash position enables Dynavax to invest in pipeline development while returning capital to shareholders through its share repurchase program.
As shown in the following financial summary, Dynavax has raised its full-year 2025 adjusted EBITDA guidance to at least $80 million, up from its previous guidance of at least $75 million:
The company’s capital allocation strategy balances investments in HEPLISAV-B commercialization, pipeline development, and shareholder returns. The Board of Directors authorized a new share repurchase program of up to $100 million, bringing the total authorized repurchases to approximately $300 million since November 2024.
Forward-Looking Statements
Dynavax provided updated guidance for full-year 2025, projecting HEPLISAV-B net revenue between $315 million and $325 million, representing approximately 17-21% growth compared to 2024. The company expects adjusted EBITDA of at least $80 million for the full year.
Looking ahead, Dynavax anticipates several key pipeline milestones in the coming years:
1. Continued enrollment in Part 2 of the Phase 1/2 shingles vaccine trial, targeting adults aged 70 and older
2. Advancement of the plague vaccine program in collaboration with the U.S. Department of Defense
3. Progress in the pandemic influenza adjuvant program with CEPI funding
4. Development of the Lyme disease vaccine program
5. Ongoing Phase 2b trial for the oral COVID-19 vaccine with topline efficacy data expected in late 2026
CEO Ryan Spencer commented during the earnings call, "We believe this data set is an important milestone and will provide the opportunity to explore strategic partnerships to realize the global value of this vaccine candidate," referring to the promising shingles vaccine results.
The company remains focused on its core strategic priorities: maximizing HEPLISAV-B’s commercial potential, advancing its diversified vaccine pipeline leveraging the CpG 1018 adjuvant, and maintaining disciplined capital allocation to drive long-term growth.
Full presentation:
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