Financial Data and Key Metrics Changes - Dynavax reported Q2 2025 net product revenue of $92 million, a 31% increase year over year, and total revenues of approximately $95 million, up 29% year over year [5][26] - HEPLISAV B gross margin was 85% for Q2 2025, an increase from 83% in Q2 2024 [27] - GAAP net income for Q2 2025 was $19 million compared to $11 million in Q2 2024, and non-GAAP adjusted EBITDA improved to $37 million from $20 million year over year [28][29] Business Line Data and Key Metrics Changes - HEPLISAV B's estimated market share in the U.S. adult hepatitis B vaccine market rose to 45% in Q2 2025 from 42% in the same period last year [6][12] - Total HEPLISAV B dose volume grew by approximately 13% year over year [12] - The company updated its full year 2025 Hepatitis B net product revenue guidance to $315 million to $325 million, raising the low end of the range [6][30] Market Data and Key Metrics Changes - The U.S. adult hepatitis B vaccine market is experiencing strong momentum due to increasing awareness and higher vaccination rates [11] - Retail segment performance showed a 35% increase in annual dose utilization, with expectations that retail will account for at least 50% of total hepatitis B doses by 2030 [15][18] - The ACIP universal recommendation has transformed the adult hepatitis B vaccine market, creating one of the largest addressable vaccination opportunities in the U.S. [12] Company Strategy and Development Direction - Dynavax aims to achieve at least 60% market share in the U.S. adult hepatitis B vaccine market by 2030, with expectations of double-digit annual growth in product net sales [6][19] - The company is advancing its vaccine pipeline, including a novel shingles program and programs in pandemic influenza and Lyme disease, leveraging its CpG 1018 adjuvant technology [7][21] - A disciplined capital allocation approach is being employed to support HEPLISAV B and advance internal pipeline programs while assessing attractive opportunities [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of HEPLISAV B and the overall market dynamics supporting continued growth [19][20] - The company remains focused on building a robust product portfolio and development pipeline, with a commitment to financial discipline [9][30] - Management highlighted the importance of retail partnerships and recent Medicare policy changes that enhance HEPLISAV B's growth potential [18] Other Important Information - The company completed a $200 million share repurchase program during Q2 2025, retiring over 16 million shares [29] - Cash, cash equivalents, and marketable securities at the end of Q2 2025 were $614 million, down from $714 million at the end of Q2 2024 [29] Q&A Session Summary Question: Inquiry about shingles readout and CD4 T cells - Management confirmed that they will focus on VRR as a composite endpoint at one month, with further assessments at six and twelve months [33][35] Question: HEPLISAV's performance and market share segments - Management clarified that there were no one-time issues affecting HEPLISAV's strong performance, attributing it to widespread adoption, particularly in retail [42][44] Question: Shift to retail and long-term guidance - Management explained that the shift to retail is driven by proactive outreach and aligns with trends seen in other adult vaccines, maintaining confidence in long-term guidance [48][50] Question: Plague program and DoD commitment - Management stated that they are fully aligned with the DoD on the plague program, with funding already awarded through the first half of 2027 [68][70] Question: Lyme disease enrollment and seasonal elements - Management indicated that seasonality will be considered in the clinical development plan for Lyme disease, focusing on safety and immunogenicity in upcoming studies [70]

Summary of Dynavax (DVAX) FY Conference Call - June 03, 2025 Company Overview - Dynavax is a commercial stage biopharmaceutical company focused on developing novel vaccines to combat infectious diseases using its proprietary CpG 1018 adjuvant [4][5] - The lead product, HEPLISAV B, is an adult hepatitis B vaccine approved in the United States, Europe, and Great Britain [4] Financial Position - As of Q1, Dynavax reported over $660 million in cash and cash equivalents, indicating a strong financial profile to support corporate strategy [5] - The company reiterated revenue guidance for HEPLISAV B in 2025, projecting $300 million to $325 million, with expectations trending towards the top half of that range [9][26] HEPLISAV B Insights - HEPLISAV B is a two-dose vaccine regimen delivered over one month, contrasting with competitors that require three doses over six months [8] - The vaccine offers higher levels of seroprotection and improved compliance due to fewer doses [8] - Revenue growth for HEPLISAV B has been significant, with a 65% CAGR projected through 2024 [9] - The U.S. market for hepatitis B vaccines is expected to grow to over $900 million by 2030, up from $615 million in 2024 [10] Market Dynamics - The growth in the hepatitis B vaccine market is anticipated to be driven by increased vaccination rates following universal recommendations for adult vaccination [10] - Retail pharmacies are expected to be a major growth channel, with Dynavax holding over 58% market share in this segment [11][12] Strategic Priorities 1. **Advancing HEPLISAV B**: Focus on increasing market share and sales in the U.S. [6] 2. **Clinical Pipeline Development**: Ongoing preclinical and clinical collaborations leveraging the CpG 1018 adjuvant [7] 3. **Commercialization Opportunities**: Exploring late-stage vaccines or synergistic products for commercialization [7] Vaccine Development Pipeline - **Shingles Vaccine**: Aiming for improved tolerability compared to the current market leader, Shingrix, with a phase one study showing promising results [14][15] - **Plague Vaccine**: Collaboration with the Department of Defense, with a $30 million contract running through mid-2027 [19][20] - **Pandemic Influenza Program**: Designed to leverage strengths from COVID-19 experiences, focusing on dose-sparing strategies [20][21] - **Lyme Disease Program**: Aiming to reduce dosing regimens and extend booster intervals, with clinical trials expected to begin in 2027 [22][23] Financial Strategy - Dynavax has initiated a $200 million share buyback program, having completed 85% of it as of the last earnings call [24][26] - The capital allocation strategy focuses on HEPLISAV B, advancing the development pipeline, and evaluating returns of excess capital [25] Conclusion - Dynavax is positioned for significant growth with HEPLISAV B and a robust pipeline of vaccine candidates, supported by a strong financial position and strategic market initiatives [27]