Core Viewpoint - Dynavax Technologies Corporation is actively participating in the 8th Annual Evercore Healthcare Conference, indicating its ongoing engagement with investors and the healthcare community [1]. Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines to combat infectious diseases [3]. - The company has two commercial products: HEPLISAV-B, a hepatitis B vaccine approved in the U.S., EU, and UK for adults aged 18 and older, and the CpG 1018 adjuvant, utilized in HEPLISAV-B and various adjuvanted COVID-19 vaccines [3]. Investor Engagement - The upcoming fireside chat at the Evercore Healthcare Conference is scheduled for December 2nd at 2:10 p.m. ET, which will be accessible via the company's website [1][2].

Financial Performance - HEPLISAV-B net product revenue reached $90 million in Q3'25, a 13% year-over-year increase compared to $79 million in Q3'24[5, 81] - The company anticipates HEPLISAV-B net revenue to be between $315 million and $325 million for the full year 2025[78] - Adjusted EBITDA for FY 2025 is expected to be at least $80 million, revised up from the previous guidance of at least $75 million[9, 79, 85] - Cash, cash equivalents, and marketable securities totaled approximately $648 million as of September 30, 2025[7, 83] - Total revenues for Q3'25 were $949 million, an 18% increase from $806 million in Q3'24[77] Market Position and Strategy - HEPLISAV-B's total U S market share reached 46% at the end of Q3'25, compared to 44% in Q3'24[5, 81] - The U S adult Hepatitis B vaccine market is projected to peak at over $900 million by 2030, with HEPLISAV-B expected to achieve at least 60% of the total U S market share[5, 25] - The company is focused on maximizing HEPLISAV-B's commercial potential, advancing its diversified vaccine pipeline, and continuing a balanced capital allocation strategy[12] Pipeline Development - The company's plague vaccine program received approximately $14 million in additional funding from the U S DoD, bringing the total funding to approximately $44 million through the first half of 2027[11, 87] - Dynavax entered into an exclusive license agreement for Vaxart's oral COVID-19 vaccine candidate, involving a $25 million upfront payment and a $5 million equity investment[68] - The global shingles vaccine market size was approximately $42 billion in 2024[33]

Core Insights - Dynavax Technologies Corporation reported significant progress in its strategic initiatives during Q3 2025, particularly in the commercial performance of HEPLISAV-B and advancements in its vaccine pipeline [2][5][6]. Business Updates - Dynavax entered into an exclusive license agreement with Vaxart for its oral COVID-19 vaccine candidate, which is currently in Phase 2b clinical trials [3][6]. - The company authorized a new share repurchase program of up to $100 million, reflecting confidence in its future and commitment to returning value to shareholders [4][7]. Financial Highlights - HEPLISAV-B achieved quarterly net product revenue of $90 million, marking a 13% year-over-year increase from $79.3 million in Q3 2024 [5][16]. - Total revenues for Q3 2025 were $94.9 million, an 18% increase compared to $80.6 million in Q3 2024 [16]. - GAAP net income for Q3 2025 was $26.9 million, or $0.23 per share, compared to $17.6 million, or $0.13 per share, in Q3 2024 [16][31]. Market Position - HEPLISAV-B's total estimated market share in the U.S. increased to approximately 46%, up from 44% in Q3 2024, with retail market share growing to about 63% from 55% [10][16]. - The U.S. hepatitis B adult vaccine market is expected to peak at over $900 million in annual sales by 2030, with HEPLISAV-B projected to achieve at least 60% market share [10][16]. Clinical Pipeline - Dynavax is advancing its shingles vaccine candidate Z-1018, which has shown positive topline data in clinical trials, and is expected to report further results in 2026 [11][12]. - The company is also developing a plague vaccine candidate and a Lyme disease vaccine candidate, both leveraging its CpG 1018 adjuvant technology [9][12][16].

Core Insights - Dynavax Technologies Corporation and Vaxart, Inc. have entered into an exclusive worldwide license and collaboration agreement for Vaxart's investigational oral COVID-19 vaccine candidate [1][3][6] Financial Terms - Dynavax will pay Vaxart an upfront license fee of $25 million and make a $5 million equity investment [3][10] - Additional payments may include up to $50 million after Phase 2b results, $195 million in regulatory milestone payments, and $425 million in potential future net sales milestone payments [10] Vaccine Development - Vaxart's oral vaccine candidate utilizes a novel mechanism of action and delivery method, aiming to induce mucosal immunity and improve patient acceptance [2][4] - The ongoing Phase 2b clinical trial involves approximately 5,400 participants and compares Vaxart's oral vaccine to an FDA-approved mRNA vaccine [7][10] Collaboration Goals - The collaboration aims to leverage Vaxart's oral vaccine platform and Dynavax's commercial experience to address the long-term need for easily administered COVID-19 vaccine options [6][10] - Vaxart will retain operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the Phase 2b trial [3][10] Strategic Importance - The agreement allows Dynavax to evaluate Phase 2b data before committing to late-stage development, aligning with its strategy to build a diversified vaccine portfolio [4][6] - Vaxart's proprietary VAAST™ platform is designed for room-temperature stable pill vaccines, potentially enhancing global distribution and compliance [4][8]

Core Insights - Dynavax Technologies Corporation has presented positive topline data from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate, and has initiated Part 2 of the trial to evaluate Z-1018 against Shingrix in older adults [1][3] Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, including HEPLISAV-B for hepatitis B and the CpG 1018 adjuvant used in various vaccines [8] Clinical Trial Details - Part 1 of the Phase 1/2 trial was a randomized, observer-blinded, active-controlled, dose escalation study assessing the safety, tolerability, and immunogenicity of Z-1018 in healthy adults aged 50 to 69 years, evaluating three different dose levels of gE antigen and two adjuvant formulations [2][5] - The key safety endpoint was solicited local and systemic post-injection reactions measured for up to seven days post-injection, while key immunogenicity endpoints included vaccine response rates for anti-gE IgG antibodies and gE-specific CD4+ T cells [2] Part 2 Trial Initiation - Part 2 of the trial has been initiated, enrolling approximately 324 healthy adults aged 70 years and older, aimed at further characterizing immunogenicity, safety, and tolerability of Z-1018 compared to Shingrix [3][6] - The company anticipates reporting topline immunogenicity and safety data from Part 2 in the second half of 2026 [3] Vaccine Performance - Z-1018 demonstrated comparable antibody and CD4+ T-cell responses to Shingrix with a favorable tolerability profile, showing robust polyfunctional CD4+ T-cell responses [5][6] - The formulation selected for advancement in Part 2 consists of 100 mcg gE adjuvanted with CpG 1018 plus alum, administered at 0 and 8 weeks [6][7] Shingles Background - Shingles, caused by the reactivation of the varicella-zoster virus, affects approximately 1 in 3 people in their lifetime and can lead to serious complications, particularly in older adults [4]

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]