Dynavax (DVAX) FY 2025 Conference September 03, 2025 04:30 PM ET Speaker0Good afternoon. Thank you all for joining and welcome to the Dynavax Technologies fireside chat at the Wells Fargo Healthcare Conference. My name is Jason Ellis. I'm Managing Director on our Healthcare Investment Banking team. I have the distinct pleasure today of having with me Ryan Spencer, Chief Executive Officer and Kelly McDonald, CFO of Dynavax.Ryan, Kelly, thanksSpeaker1for being here. Thank you so much for having us.Speaker0It' ...

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]

Financial Data and Key Metrics Changes - Dynavax reported its highest ever first quarter net revenue for HEPLISAV B at $65 million, a 36% increase year over year [5][25] - Total revenues for the first quarter reached $68 million, up 34% year over year [25] - HEPLISAV B gross margin improved to 79% from 77% in the same quarter last year [25] - GAAP net loss for the first quarter was $96 million, compared to a net loss of $9 million in the first quarter of the previous year [27][28] - Non-GAAP adjusted EBITDA improved to negative $4 million from negative $7 million year over year [28] Business Line Data and Key Metrics Changes - The retail segment for HEPLISAV B saw a 70% year over year growth in total market dose volume [12][14] - HEPLISAV B's estimated U.S. market share rose to 43% in Q1, up from 41% in the same period last year [15] - The company anticipates continued market share gains throughout 2025, aiming for at least 60% market share by 2030 [16][17] Market Data and Key Metrics Changes - The U.S. adult hepatitis B vaccine market has expanded significantly due to ACIP's universal recommendation, leading to a 16% increase in total market dose volume year over year [12][14] - The company expects the HEPLISAV B market opportunity to peak at over $900 million by 2030 [16] Company Strategy and Development Direction - Dynavax is focused on advancing its development pipeline, leveraging its vaccine adjuvant technology, CpG 1018, with key clinical trial milestones for shingles and plague vaccine programs [5][6] - The company announced new programs in pandemic influenza and Lyme disease, aiming to develop differentiated vaccines with lower risk development pathways [8][9] - The capital allocation strategy includes executing a $200 million share repurchase program while evaluating external opportunities for long-term growth [10][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the top half of the annual revenue guidance range for HEPLISAV B due to strong early performance [5][31] - The company anticipates a banner year in 2025, supported by strong market growth and ongoing adoption of HEPLISAV B [10][32] - Management highlighted the importance of maintaining a disciplined approach to capital allocation and the potential for long-term growth opportunities [10][31] Other Important Information - The company recorded an allowance for doubtful accounts of $11 million related to a legacy COVID-19 adjuvant commercial supply agreement [27] - The company ended the first quarter with cash, cash equivalents, and marketable securities of $661 million, down from $714 million at the end of 2024 [29] Q&A Session Summary Question: Why not officially raise the lower end of guidance if confidence in hitting the upper half? - Management stated it is prudent to maintain the overall guidance range as the year is only one quarter in, despite good progress [34] Question: How does capital allocation and business development fit into the long-term value creation? - Management emphasized a balanced strategy focusing on leveraging core assets, advancing internal development programs, and returning capital to shareholders [36][37] Question: What contributed to the less seasonality observed in the winter of 2024-2025? - Management noted a purposeful focus by retailers on non-flu vaccines, including hepatitis B, contributing to a strong start in Q1 [42][43] Question: Will the upcoming shingles data release be sufficient for a go/no-go decision? - Management clarified that while the data is important, a more comprehensive data package will be needed for a pivotal program decision [44][46] Question: Any issues with discussions with the FDA regarding new vaccine requirements? - Management indicated that they feel insulated from immediate changes and have had positive interactions with the FDA [50][51] Question: How does the Lyme vaccine compare to competitors? - Management believes their Lyme vaccine can establish a leading market share position due to a more approachable dosing regimen compared to competitors [59][60] Question: Is there an explanation for potentially slower growth in HEPLISAV B revenue? - Management stated that year-over-year comparisons are more appropriate and they expect continued growth in market share [70][71]

Financial Data and Key Metrics Changes - Dynavax reported its highest ever first quarter net revenue for HEPLISAV B at $65 million, a 36% increase compared to the previous year [5][14] - Total revenues for the first quarter reached $68 million, up 34% year over year [26] - HEPLISAV B gross margin improved to 79% from 77% in the same quarter last year, with expectations of approximately 80% for the full year 2025 [26] - GAAP net loss for the first quarter was $96 million, compared to a net loss of $9 million in the first quarter of the previous year, primarily due to debt refinancing accounting treatment [28][29] - Non-GAAP adjusted EBITDA improved to negative $4 million from negative $7 million year over year [29] Business Line Data and Key Metrics Changes - The retail segment for HEPLISAV B saw a significant year-over-year growth of approximately 70% in the first quarter [14] - HEPLISAV B's estimated U.S. market share rose to 43% in Q1, up from 41% in the same period last year [16] - The company executed over 85% of its $200 million share repurchase program as of May 5, 2025 [11][30] Market Data and Key Metrics Changes - The total market dose volume for hepatitis B vaccines increased approximately 16% year over year [13] - The company anticipates HEPLISAV B market opportunity to peak at over $900 million by 2030, capturing at least 60% market share [17] Company Strategy and Development Direction - Dynavax aims to leverage its vaccine adjuvant technology, CpG 1018, to advance its development pipeline, including shingles and plague vaccine programs, as well as new programs in pandemic influenza and Lyme disease [5][9][10] - The company maintains a disciplined approach to capital allocation while evaluating external opportunities to generate long-term growth [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the top half of the annual revenue guidance range for HEPLISAV B due to strong early performance [5][32] - The company expects continued market share gains throughout 2025, supported by strong growth in retail and other key customer segments [17] Other Important Information - The company plans to initiate a phase one/two trial for its pandemic influenza adjuvant program in the coming weeks [9][24] - The Lyme disease vaccine program is expected to enter clinical trials in 2027, with a focus on fewer doses or less frequent boosters compared to current candidates [10] Q&A Session Summary Question: Why not officially raise the lower end of guidance if confidence in hitting the upper half? - Management stated it is prudent to maintain the overall guidance range as the year is only one quarter in [35] Question: How does capital allocation and business development fit into the long-term strategy? - Management emphasized a balanced strategy focusing on leveraging core assets while also returning capital to shareholders through share buybacks [36][38] Question: What contributed to less seasonality in the winter of 2024-2025? - Management noted a purposeful focus by retailers on non-flu vaccines, including hepatitis B, contributing to growth [42] Question: Will the upcoming shingles data release be sufficient for a go/no-go decision? - Management clarified that while the data is important, a more comprehensive data package will be needed for pivotal trial decisions [44][46] Question: Any issues with discussions with the FDA regarding new vaccine requirements? - Management indicated that they have not faced significant issues and expect to engage with the FDA at the appropriate stages [50][56] Question: How does the company view the competitive landscape for the Lyme vaccine? - Management believes their product profile will support a leading market share position due to a more approachable dosing regimen [58]