Accessibility StatementSkip Navigation EMERYVILLE, Calif., Oct. 21, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today presented positive topline data from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, in a late-breaker session at IDWeek 2025. Dynavax also today announced it has initiated ...

HEPLISAV-B Performance and Market Outlook - HEPLISAV-B achieved a quarterly sales record of $92 million, a 31% increase year-over-year compared to $70 million in Q2'24[5] - HEPLISAV-B's total U S quarter-end market share reached approximately 45%, up from approximately 42% in Q2'24[5] - The U S adult Hepatitis B vaccine market is expected to peak at over $900 million by 2030, with HEPLISAV-B projected to reach at least 60% of the total U S market share[5, 25] - In 2024, the HEPLISAV-B total market share was ~$615M and is expected to increase from 44% in 2024 to at least 60% by 2030[25] Financial Highlights - The company's cash, cash equivalents, and marketable securities totaled $614 million as of June 30, 2025[7] - Adjusted EBITDA for FY 2025 is expected to be greater than $75 million[8] - Dynavax completed repurchases under the previously announced $200 million share repurchase program as of June 30, 2025[9] - Total revenues for Q2'25 were $95.4 million, a 29% increase from $73.8 million in Q2'24[53] Pipeline Development - The company expects to report top-line data results for the Shingles vaccine program in August 2025[10] - The U S DoD partnership provides approximately $30 million through 1H'27 to fund additional clinical & manufacturing activities for the Plague vaccine program[10] - The company plans to initiate a Phase 2 clinical trial for the Plague vaccine program in the second half of 2025[10]

William Blair 45th Annual Growth Stock Conference Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases June 2025 Nasdaq: DVAX Forward-Looking Statements Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Dynavax's expected financial results and market share as of and for the quarter ended M ...

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]