Dynavax(DVAX) - 2025 Q2 - Quarterly Results

Executive Summary / Company Overview Q2 2025 Highlights & CEO Statement Dynavax achieved strong Q2 2025 results with record HEPLISAV-B net product revenue and market share growth, alongside pipeline advancements - HEPLISAV-B® quarterly net product revenue reached a record $92 million, a 31% year-over-year increase[6][7] - Full-year 2025 HEPLISAV-B net product revenue guidance raised to $315 million to $325 million[6] - Shingles vaccine program Phase 1/2 clinical trial topline results expected in August 2025[6] - HEPLISAV-B's estimated total market share in the U.S. increased to approximately 45%, up from about 42% in Q2 2024[7] About Dynavax Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines to protect against infectious diseases - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines[25] - Possesses two commercial products: HEPLISAV-B® vaccine (approved in the U.S., EU, and UK for hepatitis B prevention in adults 18+) and CpG 1018® adjuvant (currently used in HEPLISAV-B and various adjuvanted COVID-19 vaccines)[25] Business Updates HEPLISAV-B® Vaccine HEPLISAV-B is the only approved adult hepatitis B vaccine in the U.S., EU, and UK that can be completed in one month, showing strong commercial performance and market share growth - HEPLISAV-B is the first and only adult hepatitis B vaccine in the U.S., EU, and UK that can be completed with two doses in one month[4] - The U.S. adult hepatitis B vaccine market is projected to exceed $900 million in annual sales by 2030, with HEPLISAV-B expected to achieve at least 60% of the total market share[7] Commercial Performance & Market Outlook HEPLISAV-B achieved record net product revenue of $91.9 million in Q2 2025, a 31% increase year-over-year, with U.S. market share growing to approximately 45% HEPLISAV-B Net Product Revenue (Millions USD) | Indicator | Q2 2025 | Q2 2024 | Year-over-Year Change | | :--- | :------------- | :------------- | :------- | | Net Product Revenue | 91.9 | 70.2 | 31% | HEPLISAV-B U.S. Market Share | Indicator | Q2 2025 | Q2 2024 | Change | | :--- | :------------- | :------------- | :--- | | Market Share | Approx. 45% | Approx. 42% | +3% | - Full-year 2025 HEPLISAV-B net product revenue guidance raised to $315 million to $325 million[6][19] Hemodialysis Indication Development Dynavax plans an observational retrospective cohort study to support the sBLA for HEPLISAV-B in adult hemodialysis patients, with FDA feedback on the proposed patient database - An observational retrospective cohort study is planned to support the sBLA application for HEPLISAV-B® vaccine in adult hemodialysis patients[12] - The U.S. FDA has provided feedback that the proposed patient database may be suitable for this observational retrospective cohort study, and the company is finalizing the study protocol with the FDA[12] Clinical and Preclinical Pipeline Dynavax is advancing a pipeline of differentiated vaccine candidates utilizing its CpG 1018® adjuvant, with key clinical milestones expected in 2025 and beyond - Dynavax is advancing a pipeline of differentiated vaccine candidates utilizing its CpG 1018® adjuvant, which has demonstrated the ability to enhance immune responses and be well-tolerated across extensive clinical trials and real-world commercial use[5] - Shingles vaccine program Phase 1/2 clinical trial topline results expected in August 2025[6] - Plague vaccine program Phase 2 clinical trial expected to commence in the second half of 2025[9] Shingles Vaccine Program (Z-1018) Z-1018, a shingles vaccine candidate for adults 50+, completed enrollment for Phase 1/2 Part 1, with topline data expected in August 2025, and plans to advance to Part 2 for older adults - Z-1018 is a vaccine candidate under development for the prevention of shingles in adults 50 years of age and older[8] - Enrollment and dosing for Part 1 of the Phase 1/2 clinical trial (441 healthy adults aged 50 to 69) have been completed, with topline immunogenicity and safety data expected in August 2025[13] - Plans to advance selected vaccine formulations and regimens from Part 1 into Part 2 of the Phase 1/2 study in adults 70 years of age and older to generate clinical proof-of-concept data in this key population and compare tolerability and immunogenicity with Shingrix®[13] Plague Vaccine Program Dynavax is collaborating with the U.S. DoD on a fully funded CpG 1018® adjuvanted plague vaccine candidate, with a new $30 million agreement and a Phase 2 trial expected in H2 2025 - Collaborating with the U.S. Department of Defense (DoD) to develop a CpG 1018® adjuvanted plague (rF1V) vaccine candidate, fully funded by the DoD[9] - Signed a new agreement with the DoD providing approximately $30 million in funding through the first half of 2027 to support additional clinical and manufacturing activities[9] - Phase 2 clinical trial expected to commence in the second half of 2025[9] Pandemic Influenza Adjuvant Program Dynavax completed enrollment for Part 1 of a Phase 1/2 study evaluating CpG 1018 adjuvanted H5N1 influenza vaccine, with topline data expected in 2026 to select the optimal formulation for Part 2 - Evaluating the use of CpG 1018 in an adjuvanted H5N1 influenza vaccine as a proof-of-concept for its potential use in pandemic influenza vaccines[10] - Enrollment and dosing for Part 1 of the Phase 1/2 study (101 participants aged 18 to 49) have been completed[14] - Expects to use Part 1 data to select the optimal CpG 1018 adjuvanted formulation to advance into Part 2, with topline immunogenicity and safety data expected in 2026[14] Lyme Disease Vaccine Program Dynavax is developing a CpG 1018 adjuvanted multivalent protein subunit Lyme disease vaccine candidate, currently in IND-enabling studies, with clinical development planned for 2027 - Developing a CpG 1018 adjuvanted multivalent protein subunit vaccine candidate for the prevention of Lyme disease[11] - The Lyme disease vaccine candidate has entered IND-enabling studies, with clinical development planned to commence in 2027[14] - The company believes its CpG 1018 adjuvanted Lyme disease vaccine candidate has the potential for a differentiated and best-in-class vaccine due to its ability to enhance immune responses and improve durability of protection[14] Financial Results & Guidance Second Quarter 2025 Financial Highlights Dynavax achieved strong Q2 2025 financial performance with significant year-over-year growth in total revenue, HEPLISAV-B net product revenue, GAAP net income, and adjusted EBITDA 2025 Second Quarter Financial Performance (Year-over-Year) | Indicator | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Year-over-Year Change (%) | | :-------------------------------- | :------------------- | :------------------- | :------------- | | Total Revenue | 95.4 | 73.8 | 29% | | HEPLISAV-B Net Product Revenue | 91.9 | 70.2 | 31% | | Cost of Sales - Product | 14.0 | 12.0 | 17% | | Research and Development Expenses | 16.6 | 15.0 | 11% | | Selling, General and Administrative Expenses | 50.4 | 41.7 | 21% | | GAAP Net Income | 18.7 | 11.4 | 64% | | GAAP Earnings Per Share (Basic) | 0.16 | 0.09 | 78% | | GAAP Earnings Per Share (Diluted) | 0.14 | 0.08 | 75% | | Adjusted EBITDA | 37.3 | 20.5 | 82% | - Cash, cash equivalents, and marketable securities totaled $613.7 million as of June 30, 2025, compared to $713.8 million as of December 31, 2024[19] - As of June 30, 2025, Dynavax has completed its $200 million stock repurchase program[19] Full Year 2025 Financial Guidance Dynavax updated its full-year 2025 financial guidance, raising the expected range for HEPLISAV-B net product revenue and reaffirming a strong adjusted EBITDA outlook Full Year 2025 Financial Guidance | Indicator | New Guidance (Millions USD) | Previous Guidance (Millions USD) | | :-------------------------- | :------------------------ | :------------------------ | | HEPLISAV-B Net Product Revenue | 315 to 325 | 305 to 325 | | Adjusted EBITDA | At least 75 | N/A | Consolidated Statements of Operations The consolidated statements of operations detail Dynavax's revenues and expenses for Q2 2025 and the six months ended June 30, 2025, showing net income for the quarter but a net loss for the six-month period due to debt extinguishment Consolidated Statements of Operations (Selected Data, in Thousands USD) | Indicator | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Net Product Revenue | $91,872 | $70,188 | $156,831 | $118,032 | | Total Revenue | $95,442 | $73,795 | $163,606 | $124,584 | | Total Operating Expenses | $81,013 | $68,597 | $172,807 | $137,157 | | Operating Income (Loss) | $14,429 | $5,198 | $(9,201) | $(12,573) | | Loss on Debt Extinguishment | — | — | $(82,095) | — | | Net Income (Loss) | $18,721 | $11,386 | $(77,378) | $2,665 | | Basic Earnings (Loss) Per Share | $0.16 | $0.09 | $(0.63) | $0.02 | | Diluted Earnings (Loss) Per Share | $0.14 | $0.08 | $(0.63) | $0.02 | Selected Balance Sheet Data The balance sheet data indicates a decrease in Dynavax's cash, cash equivalents, and marketable securities as of June 30, 2025, compared to December 31, 2024, with an increase in total current liabilities Selected Balance Sheet Data (in Thousands USD) | Indicator | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Cash, Cash Equivalents and Marketable Securities | $613,729 | $713,834 | | Total Current Assets | $785,712 | $848,941 | | Total Assets | $918,449 | $986,256 | | Total Current Liabilities | $118,230 | $78,634 | | Total Long-Term Liabilities | $306,057 | $310,823 | | Stockholders' Equity | $494,162 | $596,799 | Reconciliation of GAAP Net Loss to Adjusted EBITDA This reconciliation details the adjustment of GAAP net income (loss) to Adjusted EBITDA, including non-cash and non-recurring items like depreciation, interest, stock-based compensation, and debt extinguishment Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA (in Thousands USD) | Indicator | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | GAAP Net Income (Loss) | $18,721 | $11,386 | $(77,378) | $2,665 | | Depreciation and Amortization | 374 | 376 | 748 | 751 | | Interest Income | (6,798) | (9,201) | (14,537) | (18,668) | | Interest Expense | 1,641 | 1,698 | 3,333 | 3,393 | | Income Tax Benefit | 2,495 | 3,520 | 719 | 743 | | Stock-Based Compensation | 12,087 | 12,685 | 25,536 | 24,829 | | Loss on Debt Extinguishment | — | — | 82,095 | — | | Proxy Contest Costs | 8,827 | — | 12,520 | — | | Adjusted EBITDA | $37,347 | $20,464 | $33,036 | $13,713 | Additional Information HEPLISAV-B® Important Safety Information This section provides key safety information for HEPLISAV-B, including contraindications, potential reduced immune response in immunocompromised individuals, common adverse reactions, and considerations for pregnant or lactating individuals - Contraindications: Individuals with a history of severe allergic reaction to any hepatitis B vaccine or any component of HEPLISAV-B, including yeast[21] - Immunocompromised individuals (including those receiving immunosuppressive therapy) may have a diminished immune response to HEPLISAV-B[22] - The most common patient-reported adverse reactions within 7 days post-vaccination include injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%)[22] - There are no adequate and well-controlled studies of HEPLISAV-B in pregnant women; it is unknown whether it is excreted in human milk[23] Non-GAAP Financial Measures Dynavax uses Adjusted EBITDA as a non-GAAP financial measure to provide insights into operational activities and cash generation, excluding certain non-cash and infrequent expenses - Adjusted EBITDA is a non-GAAP financial measure used to assess normal operating activities, including the ability to generate cash from operations[26] - Adjusted EBITDA excludes interest expense, interest income, income tax benefit or provision, depreciation, amortization, stock-based compensation, and other non-recurring operating adjustments such as debt extinguishment loss and proxy contest costs[28] - There are several limitations to using Adjusted EBITDA instead of GAAP net income or loss, such as not reflecting cash requirements for depreciation or amortization, changes in working capital needs, income taxes, or capital expenditures[29][31] Forward-Looking Statements This press release contains "forward-looking" statements regarding future financial performance, growth, market share, clinical development timelines, and regulatory interactions, subject to inherent risks and uncertainties - This press release contains forward-looking statements regarding Dynavax's expected financial results, future growth and long-term performance, scope and timing of market growth and market share, timing of IND filings, initiation and completion of clinical studies, expected timing of data announcements, and interactions with regulatory agencies[30] - These statements are subject to risks and uncertainties inherent in Dynavax's business, including that market size or actual product demand may differ from expectations, risks related to HEPLISAV-B commercialization and supply capabilities, risks related to the timing of completion and results of current clinical studies, and other risks detailed in its SEC filings[32] Conference Call and Webcast Information Dynavax hosted a conference call and live audio webcast on August 7, 2025, to discuss financial results, with a webcast replay available for 30 days post-broadcast - Dynavax hosted a conference call and live audio webcast on Thursday, August 7, 2025, at 4:30 p.m. ET / 1:30 p.m. PT[17] - The webcast is accessible through the "Events & Presentations" page in the "Investors" section of the Dynavax website, with a replay available for 30 days following the live broadcast[17]