Core Insights - Dynavax Technologies reported strong Q2 2025 results, with GAAP revenue of $95.4 million, exceeding analyst expectations of $86.7 million, and GAAP diluted EPS of $0.14, surpassing the consensus estimate of $0.10, indicating significant year-over-year growth [1][2][5] Financial Performance - GAAP revenue increased by 29.3% year-over-year from $73.8 million in Q2 2024 to $95.4 million in Q2 2025 [2] - Diluted EPS rose by 75% from $0.08 in Q2 2024 to $0.14 in Q2 2025 [2] - Adjusted EBITDA improved to $37.3 million in Q2 2025, up 81.9% from $20.5 million in Q2 2024 [2] - HEPLISAV-B net product revenue reached $91.9 million, a 30.8% increase from $70.2 million in Q2 2024 [2] Market Position and Strategy - Dynavax's HEPLISAV-B vaccine captured approximately 45% of the U.S. market share, up from 42% a year earlier, with a long-term goal of achieving at least 60% market share by 2030 [5][6] - The company focuses on expanding HEPLISAV-B's market share, advancing its vaccine pipeline, and forming partnerships for commercialization and research [4][11] Clinical Pipeline Progress - Significant advancements were reported in the clinical pipeline, including the shingles vaccine candidate Z-1018, which completed enrollment for a Phase 1/2 trial [7] - The plague vaccine program, in collaboration with the U.S. Department of Defense, is set to advance to Phase 2 trials in the second half of 2025, supported by a $30 million collaboration [7] Financial Guidance - For fiscal 2025, Dynavax raised its HEPLISAV-B net product revenue guidance to a range of $315–$325 million, with a target of at least $75 million in adjusted EBITDA [12] Cash Position and Expenses - As of June 30, 2025, the company had $613.7 million in cash and marketable securities, down from $713.8 million at the end of 2024, primarily due to a $200 million share repurchase program [9][13] - R&D expenses increased by 10.7% to $16.6 million, while SG&A expenses rose by 20.9% to $50.4 million in Q2 2025 compared to the same period in 2024 [9][13]

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]

PART I FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the six months ended June 30, 2025, show a significant increase in total revenues compared to the same period in 2024, primarily driven by HEPLISAV-B sales, despite a net loss of $77.4 million largely due to a one-time $82.1 million loss on debt extinguishment [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and marketable securities | $613,729 | $713,834 | | Accounts receivables, net | $70,699 | $45,281 | | Inventories | $75,687 | $70,054 | | **Total Assets** | **$918,449** | **$986,256** | | **Liabilities & Equity** | | | | Total current liabilities | $118,230 | $78,634 | | Convertible Notes, net | $260,772 | $223,854 | | **Total Liabilities** | **$424,287** | **$389,457** | | **Total Stockholders' Equity** | **$494,162** | **$596,799** | - Total assets decreased primarily due to a reduction in cash and marketable securities, partly used for share repurchases and debt refinancing. Total liabilities increased due to the issuance of new 2030 Convertible Notes, partially offset by the exchange of 2026 Notes[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $95,442 | $73,795 | $163,606 | $124,584 | | Income (Loss) from Operations | $14,429 | $5,198 | $(9,201) | $(12,573) | | Loss on debt extinguishment | $0 | $0 | $(82,095) | $0 | | **Net Income (Loss)** | **$18,721** | **$11,386** | **$(77,378)** | **$2,665** | | Diluted EPS | $0.14 | $0.08 | $(0.63) | $0.02 | - Total revenues grew **29% YoY in Q2 2025** and **31% YoY for the six months ended June 30, 2025**, driven by strong HEPLISAV-B sales. The significant net loss for the first six months of 2025 was primarily caused by a one-time, non-cash loss of **$82.1 million** on debt extinguishment related to the March 2025 refinancing transaction[17](index=17&type=chunk)[72](index=72&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $3,792 | $(5,966) | | Net cash provided by (used in) investing activities | $101,702 | $(25,936) | | Net cash used in financing activities | $(103,800) | $(5,618) | | **Net increase (decrease) in cash** | **$3,252** | **$(37,785)** | - For the first six months of 2025, cash from operations turned positive. Investing activities provided cash due to net proceeds from marketable securities. Financing activities used significant cash for share repurchases (**$100.6 million**) and debt extinguishment payments (**$80.9 million**), partially offset by proceeds from new debt issuance and unwound capped calls[25](index=25&type=chunk) [Notes to Financial Statements](index=10&type=section&id=Notes%20to%20Financial%20Statements) Key notes to the financial statements detail the company's collaborative agreements, a significant debt refinancing transaction, revenue recognition policies, and the completion of its share repurchase program - An allowance for doubtful accounts of approximately **$11.0 million** was recorded relating to the contract asset for Clover, based on an evaluation of credit risk after GAVI terminated its purchase agreement with Clover[60](index=60&type=chunk)[137](index=137&type=chunk) - In March 2025, the company completed a refinancing transaction, issuing **$225.0 million** of 2.00% Convertible Senior Notes due 2030 to exchange and repurchase a portion of its 2.50% Convertible Senior Notes due 2026, resulting in a recognized loss on debt extinguishment of **$82.1 million**[68](index=68&type=chunk)[72](index=72&type=chunk)[151](index=151&type=chunk) - The company completed its **$200.0 million** share repurchase program, repurchasing a total of **16.6 million shares** during the six months ended June 30, 2025, including shares under an Accelerated Share Repurchase (ASR) agreement and through open market transactions[105](index=105&type=chunk)[107](index=107&type=chunk)[156](index=156&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 33% year-over-year revenue growth for the first six months of 2025 to increased HEPLISAV-B sales volume and higher net pricing, while operating expenses rose due to R&D investments and proxy contest costs, leading to a net loss of $77.4 million driven by a debt extinguishment loss [Overview and Pipeline Update](index=28&type=section&id=Overview%20and%20Pipeline%20Update) - The company's strategy focuses on maximizing HEPLISAV-B utilization, expanding its vaccine pipeline using the CpG 1018 adjuvant, and leveraging CpG 1018 supply through collaborations[127](index=127&type=chunk) - Key pipeline programs leveraging the CpG 1018 adjuvant are advancing: - **Shingles (Z-1018):** Top-line immunogenicity and safety data from a Phase 1/2 trial comparing Z-1018 to Shingrix are expected in August 2025 - **Plague:** A new **$30 million** agreement with the DoD will support a Phase 2 trial expected to start in H2 2025 - **Pandemic Influenza (H5N1):** A Phase 1/2 study is ongoing, with data expected to inform formulation selection for Part 2 of the trial - **Lyme Disease:** The vaccine candidate has progressed to IND-enabling studies, with clinical development planned to start in 2027 - **HEPLISAV-B (Hemodialysis):** Engaging with the FDA to finalize the protocol for an observational study to support an sBLA filing for a four-dose regimen[143](index=143&type=chunk)[144](index=144&type=chunk)[149](index=149&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Revenue Comparison (in thousands) | Revenue Source | YTD 2025 | YTD 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | HEPLISAV-B | $156,831 | $118,032 | $38,799 | 33% | | Other revenue | $6,775 | $6,552 | $223 | 3% | | **Total Revenues** | **$163,606** | **$124,584** | **$39,022** | **31%** | - The **$38.8 million** increase in HEPLISAV-B revenue for the first six months of 2025 was driven by higher sales volume (**$17.2 million**), increases in net sales price (**$14.0 million**), and favorable adjustments to the product returns reserve estimate (**$6.8 million**)[163](index=163&type=chunk) Operating Expense Comparison - YTD (in thousands) | Expense Category | YTD 2025 | YTD 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Cost of Sales - Product | $27,804 | $22,952 | $4,852 | 21% | | Research & Development | $35,996 | $28,478 | $7,518 | 26% | | Selling, General & Administrative | $98,037 | $85,727 | $12,310 | 14% | | Bad Debt Expense | $10,970 | $0 | $10,970 | N/A | - R&D expenses increased by **$7.5 million** YTD, primarily due to the shingles Phase 1/2 trial and advancing the pandemic influenza and Lyme disease programs. SG&A expenses increased by **$12.3 million** YTD, mainly driven by **$12.5 million** in professional fees related to a proxy contest[171](index=171&type=chunk)[174](index=174&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$613.7 million** in cash, cash equivalents, and marketable securities. Management believes these funds, along with anticipated HEPLISAV-B revenues, are sufficient to fund operations for at least the next 12 months[181](index=181&type=chunk) - The company completed its **$200.0 million** share repurchase program as of June 30, 2025[184](index=184&type=chunk) - Following the refinancing, the total principal balance of outstanding convertible notes was **$265.2 million**, comprising **$40.2 million** of 2026 Notes (due May 2026) and **$225.0 million** of 2030 Notes (due March 2030)[185](index=185&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states there were no material changes to its market risk disclosures during the six months ended June 30, 2025, as compared to those in its 2024 Annual Report on Form 10-K - No material changes to market risk disclosures were reported for the period[196](index=196&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal controls over financial reporting during the quarter - Management concluded that disclosure controls and procedures are effective at a reasonable assurance level[198](index=198&type=chunk) - No material changes to internal controls over financial reporting were identified during the most recent fiscal quarter[199](index=199&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently aware of any material legal proceedings involving the company - The company reports no material legal proceedings as of the filing date[201](index=201&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The company highlights several material risks, including significant competition for HEPLISAV-B, potential for financial results to vary significantly, and reliance on third parties for manufacturing, alongside new risks from global trade policies, activist stockholders, and financial risks associated with its convertible notes - HEPLISAV-B, the company's first and only marketed product, faces significant competition in the U.S., and its commercial success is not guaranteed[206](index=206&type=chunk) - The company relies on its facility in Germany and third-party suppliers for manufacturing, including a single supplier for the pre-filled syringe presentation of HEPLISAV-B, creating supply chain risk[226](index=226&type=chunk) - A new risk factor was added concerning global trade issues, noting that new tariffs (such as a 10% global tariff and 125% on Chinese goods) could increase manufacturing costs and disrupt the supply chain, as key manufacturing processes occur in Germany[269](index=269&type=chunk)[270](index=270&type=chunk)[273](index=273&type=chunk) - The company notes that actions by activist stockholders, such as the recent proxy contest, can be disruptive, costly, and divert management's attention[352](index=352&type=chunk) - Servicing the **$265.2 million** in outstanding convertible notes requires significant cash, and conversion of the notes could dilute shareholder ownership[353](index=353&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports the completion of its $200.0 million share repurchase program as of June 30, 2025, with 6,596,048 shares repurchased during the second quarter of 2025 at an average price of $10.75 per share - The company has completed all repurchases under its authorized **$200.0 million** share repurchase program[383](index=383&type=chunk) Share Repurchases in Q2 2025 | Period | Total Shares Purchased | Average Price Paid per Share ($) | | :--- | :--- | :--- | | April 2025 | 3,342,919 | $11.36 | | May 2025 | 3,253,129 | $10.12 | | June 2025 | 0 | $0.00 | | **Total Q2** | **6,596,048** | **$10.75** |

[Executive Summary / Company Overview](index=1&type=section&id=Executive%20Summary%20%2F%20Company%20Overview) [Q2 2025 Highlights & CEO Statement](index=1&type=section&id=Q2%202025%20Highlights%20%26%20CEO%20Statement) 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](index=6&type=chunk)[7](index=7&type=chunk) - Full-year 2025 HEPLISAV-B net product revenue guidance raised to **$315 million to $325 million**[6](index=6&type=chunk) - Shingles vaccine program Phase 1/2 clinical trial topline results expected in **August 2025**[6](index=6&type=chunk) - HEPLISAV-B's estimated total market share in the U.S. increased to approximately **45%**, up from about 42% in Q2 2024[7](index=7&type=chunk) [About Dynavax](index=4&type=section&id=About%20Dynavax) 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](index=25&type=chunk) - 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](index=25&type=chunk) [Business Updates](index=1&type=section&id=Business%20Updates) [HEPLISAV-B® Vaccine](index=1&type=section&id=HEPLISAV-B%C2%AE%20Vaccine) 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](index=4&type=chunk) - 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](index=7&type=chunk) [Commercial Performance & Market Outlook](index=1&type=section&id=Commercial%20Performance%20%26%20Market%20Outlook) 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](index=6&type=chunk)[19](index=19&type=chunk) [Hemodialysis Indication Development](index=2&type=section&id=Hemodialysis%20Indication%20Development) 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](index=12&type=chunk) - 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](index=12&type=chunk) [Clinical and Preclinical Pipeline](index=1&type=section&id=Clinical%20and%20Preclinical%20Pipeline) 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](index=5&type=chunk) - Shingles vaccine program Phase 1/2 clinical trial topline results expected in **August 2025**[6](index=6&type=chunk) - Plague vaccine program Phase 2 clinical trial expected to commence in the **second half of 2025**[9](index=9&type=chunk) [Shingles Vaccine Program (Z-1018)](index=2&type=section&id=Shingles%20Vaccine%20Program%20(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](index=8&type=chunk) - 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](index=13&type=chunk) - 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](index=13&type=chunk) [Plague Vaccine Program](index=2&type=section&id=Plague%20Vaccine%20Program) 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](index=9&type=chunk) - 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](index=9&type=chunk) - Phase 2 clinical trial expected to commence in the **second half of 2025**[9](index=9&type=chunk) [Pandemic Influenza Adjuvant Program](index=2&type=section&id=Pandemic%20Influenza%20Adjuvant%20Program) 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](index=10&type=chunk) - Enrollment and dosing for Part 1 of the Phase 1/2 study (101 participants aged 18 to 49) have been completed[14](index=14&type=chunk) - 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](index=14&type=chunk) [Lyme Disease Vaccine Program](index=2&type=section&id=Lyme%20Disease%20Vaccine%20Program) 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](index=11&type=chunk) - The Lyme disease vaccine candidate has entered IND-enabling studies, with clinical development planned to commence in **2027**[14](index=14&type=chunk) - 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](index=14&type=chunk) [Financial Results & Guidance](index=3&type=section&id=Financial%20Results%20%26%20Guidance) [Second Quarter 2025 Financial Highlights](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) 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](index=19&type=chunk) - As of June 30, 2025, Dynavax has completed its **$200 million** stock repurchase program[19](index=19&type=chunk) [Full Year 2025 Financial Guidance](index=3&type=section&id=Full%20Year%202025%20Financial%20Guidance) 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](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) 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](index=8&type=section&id=Selected%20Balance%20Sheet%20Data) 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](index=9&type=section&id=Reconciliation%20of%20GAAP%20Net%20Loss%20to%20Adjusted%20EBITDA) 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](index=4&type=section&id=Additional%20Information) [HEPLISAV-B® Important Safety Information](index=4&type=section&id=HEPLISAV-B%C2%AE%20Important%20Safety%20Information) 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](index=21&type=chunk) - Immunocompromised individuals (including those receiving immunosuppressive therapy) may have a diminished immune response to HEPLISAV-B[22](index=22&type=chunk) - 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](index=22&type=chunk) - 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](index=23&type=chunk) [Non-GAAP Financial Measures](index=4&type=section&id=Non-GAAP%20Financial%20Measures) 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](index=26&type=chunk) - 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](index=28&type=chunk) - 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](index=29&type=chunk)[31](index=31&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) 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](index=30&type=chunk) - 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](index=32&type=chunk) [Conference Call and Webcast Information](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Information) 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](index=17&type=chunk) - 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](index=17&type=chunk)

EMERYVILLE, Calif., July 29, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report second quarter 2025 financial results on Thursday, August 7, 2025, after the U.S. financial markets close. Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies To dial into the call, participants will need to register for the call using the call ...

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 ...

Core Points - Dynavax Technologies Corporation announced the election of all four director nominees to its Board of Directors during the 2025 Annual Meeting of Stockholders [1] - Stockholders approved all other proposals recommended by the Board, including the phased declassification of the Board [2] - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, with two commercial products: HEPLISAV-B® and CpG 1018® adjuvant [4] Company Overview - Dynavax is engaged in the development and commercialization of vaccines aimed at protecting against infectious diseases [4] - The company’s HEPLISAV-B® vaccine is approved in the U.S., EU, and UK for preventing hepatitis B virus infections in adults aged 18 and older [4] - CpG 1018® adjuvant is utilized in HEPLISAV-B and various adjuvanted COVID-19 vaccines [4]

Core Viewpoint - Dynavax Technologies Corporation emphasizes the importance of re-electing its four director nominees to maintain strategic leadership and long-term stockholder value, contrasting this with the detrimental plans proposed by Deep Track [2][3][4]. Company Strategy and Performance - Since 2019, Dynavax has successfully repositioned its business, leading to significant stockholder value, with a total return of 203% over the last five years, outperforming vaccine peers (9% return) and the S&P Biotechnology Select Industry Index (-17% decline) [2][4]. - The company has generated over $950 million in revenue between 2020 and 2022, supported by a disciplined capital allocation plan, including over 85% execution of a $200 million share repurchase program authorized in November 2024 [4]. Board Composition and Qualifications - The current board, which includes nominees Brent MacGregor, Scott Myers, Lauren Silvernail, and Elaine Sun, possesses essential strategic leadership and expertise in vaccines, biotechnology, and finance, which are critical for the company's long-term strategy [3][5]. - The board has been reshaped with new independent directors, ensuring that six of the eight directors appointed since 2020 bring specialized skill sets aligned with Dynavax's strategic goals [5]. Opposition to Deep Track - Deep Track's candidates are criticized for lacking the necessary experience in corporate strategy and operations, with their proposed plan seen as a threat to Dynavax's long-term growth potential [2][3]. - Independent proxy advisory firms ISS and Egan-Jones have recommended stockholders support Dynavax's nominees, highlighting concerns over Deep Track's misleading materials and lack of a compelling case for change [4][5].

Core Viewpoint - Dynavax Technologies Corporation is emphasizing the effectiveness of its current board and strategic direction, asserting that it has created significant long-term stockholder value, particularly through its focus on vaccine development and capital return strategies [1][2][3]. Company Strategy and Performance - Dynavax's strategic pivot in 2019 towards vaccines has led to substantial stockholder value creation, with a reported total return of 203% over the last five years, significantly outperforming vaccine peers (9%) and the S&P Biotechnology Select Industry Index (-17%) [2][3]. - The company has achieved market leadership with its HEPLISAV-B® vaccine, generating $268 million in net product revenue in 2024 and capturing a 44% market share in the U.S. adult hepatitis B vaccine market [2][3]. - In the first quarter of 2025, HEPLISAV-B® net product revenue reached $65 million, reflecting a 36% year-over-year increase, contributing to total revenue of $68.2 million, a 34% increase year-over-year [2][3]. Board Composition and Governance - The board has undergone significant refreshment, with six of the eight independent directors appointed since 2020, ensuring a balanced mix of experience and expertise in the healthcare sector [2][9]. - Dynavax's nominees for the board, including Brent MacGregor, Scott Myers, Lauren Silvernail, and Elaine Sun, are highlighted as possessing critical expertise necessary for guiding the company through pivotal developments [4][5]. Capital Return Strategy - As of May 5, 2025, Dynavax has executed over 85% of its $200 million share repurchase program, which represents 47% of its capital use, indicating a strong commitment to returning capital to stockholders [9].

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]