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].

Group 1 - The article does not provide any specific information or data regarding companies or industries [1]

Core Insights - Dynavax Technologies reported quarterly earnings of $0.21 per share, exceeding the Zacks Consensus Estimate of $0.14 per share, and showing an increase from $0.12 per share a year ago, resulting in an earnings surprise of +50.00% [1] - The company posted revenues of $94.88 million for the quarter ended September 2025, slightly missing the Zacks Consensus Estimate by 0.23%, but up from $80.63 million year-over-year [2] - Dynavax Technologies has surpassed consensus EPS estimates three times over the last four quarters and topped consensus revenue estimates two times in the same period [2] Earnings Outlook - The sustainability of the stock's price movement will depend on management's commentary during the earnings call and future earnings expectations [3][4] - The current consensus EPS estimate for the upcoming quarter is $0.05 on revenues of $77.49 million, while for the current fiscal year, it is -$0.43 on revenues of $336.19 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Dynavax belongs, is currently ranked in the top 40% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Dynavax reported net product revenue of approximately $90 million for Q3 2025, representing a 13% increase year over year, and total revenues of approximately $95 million, up 18% year over year [18][19] - GAAP net income for Q3 2025 was $27 million, compared to $18 million in Q3 2024, while non-GAAP adjusted EBITDA improved to $36 million from $25 million year over year [20] - The company ended Q3 2025 with cash and equivalents of $648 million, down from $714 million at the end of 2024, primarily due to a completed $200 million share repurchase program [21] Business Line Data and Key Metrics Changes - Heplisav-B generated approximately $90 million in net product revenue, achieving a 46% market share in the U.S. adult hepatitis B vaccine market, up from 44% in the prior year [10][11] - The retail segment market share for Heplisav-B grew to 63%, compared to 59% in Q3 of the previous year, indicating strong performance in this critical growth segment [10][11] Market Data and Key Metrics Changes - The adult hepatitis B vaccine market is expanding under the ACIP universal recommendation, with a large catch-up cohort of over 100 million unprotected adults [10] - The overall market for adult hepatitis B vaccines is expected to peak at over $900 million in the U.S. by 2030, with Dynavax targeting at least 60% market share [12][13] Company Strategy and Development Direction - Dynavax is focused on maximizing and growing Heplisav-B, advancing its internal pipeline, and executing strategically aligned business development transactions [59] - The company has entered into a strategic license agreement with Vaxart for a novel oral COVID-19 vaccine program, which is expected to provide improved protection through intestinal delivery [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the long-term goal of at least 60% market share for Heplisav-B by 2030, supported by ongoing growth in the retail segment and increased awareness of the ACIP recommendation [12][13] - The company anticipates continued growth and progress in its pipeline, with key milestones expected in the second half of 2026 [23][24] Other Important Information - A new $100 million share repurchase program was authorized, reflecting the company's commitment to enhancing shareholder value [21][24] - R&D expenses for Q3 2025 were $19 million, up from $14 million in the same quarter last year, reflecting advancements in the pipeline [19] Q&A Session Summary Question: Why license a COVID vaccine now? - Management believes this is a strategic opportunity to grow the market with improved vaccine options, despite recent challenges in the COVID vaccine landscape [26][27] Question: What is the power of the trial with 5,400 patients? - The study is adequately powered to demonstrate improvement over the comparator mRNA vaccine, despite the reduction in size [28] Question: Will the company be able to conduct registrational studies for both shingles and the oral COVID-19 vaccine simultaneously? - Management confirmed that they are capable of managing the staging of activities for both programs [30][31] Question: What is needed to advance the oral vaccine program? - The goal is to demonstrate an improved option compared to the mRNA vaccine, with a focus on both efficacy and tolerability [35][36] Question: How does seasonality affect Heplisav-B revenue in Q4? - Management acknowledged that seasonality exists but expects stronger fourth quarters as retail continues to grow in adult immunizations [38][39] Question: What is the long-term outlook for Heplisav-B market share? - Management is confident in achieving the 60% market share target by 2030, with ongoing progress expected [52][54]

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]

Financial Performance - Total revenues for Q3 2025 reached $94.876 million, a 17.5% increase from $80.630 million in Q3 2024[17] - Product revenue, net for Q3 2025 was $89.954 million, up from $79.345 million in Q3 2024, representing a 13.5% growth[17] - Net income for Q3 2025 was $26.927 million, compared to $17.594 million in Q3 2024, reflecting a 53.1% increase[20] - Total revenues for the three months ended September 30, 2025, were $94.9 million, an increase from $80.6 million in the same period of 2024, representing a growth of 17.6%[96] - Segment income for the three months ended September 30, 2025, was $26.9 million, compared to $17.6 million in the same period of 2024, indicating a significant improvement[96] - HEPLISAV-B product revenue in the U.S. for the nine months ended September 30, 2025, was $246.785 million, up from $197.377 million in the same period of 2024, indicating a growth of about 25%[97] - HEPLISAV-B product revenue increased by $10.6 million (13%) for Q3 2025 and $49.4 million (25%) for the first nine months of 2025 compared to the same periods in 2024[171] - Total revenues for the first nine months reached $258.5 million, up $53.3 million (26%) from 2024[171] Assets and Liabilities - Total current assets decreased to $814.331 million as of September 30, 2025, from $848.941 million at December 31, 2024[15] - Total liabilities increased to $412.368 million as of September 30, 2025, compared to $389.457 million at December 31, 2024[15] - Cash and cash equivalents rose to $160.247 million as of September 30, 2025, up from $95.883 million at December 31, 2024[15] - Total stockholders' equity decreased to $534.138 million as of September 30, 2025, from $596.799 million at December 31, 2024[15] - As of September 30, 2025, total cash and cash equivalents amounted to $160,247,000, an increase from $95,883,000 as of December 31, 2024[46] - Total marketable securities available-for-sale reached $487,568,000 as of September 30, 2025, compared to $617,951,000 as of December 31, 2024[47] - The total fair value of financial assets measured at fair value on a recurring basis was $629,951,000 as of September 30, 2025, down from $701,677,000 as of December 31, 2024[44] Cash Flow - Net cash provided by operating activities was $37,621,000 for the nine months ended September 30, 2025, an increase from $13,501,000 in the same period of 2024[26] - During the nine months ended September 30, 2025, the company generated $37.6 million of cash from operations, despite a net loss of $50.5 million[199] - Net cash provided by investing activities was $129.0 million for the nine months ended September 30, 2025, compared to $41.4 million used in the same period in 2024, primarily due to $135.6 million of net proceeds from marketable securities[201] - Cash used in financing activities was $103.9 million for the nine months ended September 30, 2025, including $80.9 million for debt extinguishment and $101.2 million for stock repurchases[202] Research and Development - Research and development expenses for the nine months ended September 30, 2025, totaled $55.112 million, compared to $42.881 million for the same period in 2024[17] - Research and development expenses increased by $4.7 million (33%) in Q3 2025 and $12.2 million (29%) for the first nine months, mainly due to higher costs in the shingles and plague vaccine programs[179] - The company anticipates continued increases in research and development expenses as it progresses its clinical and preclinical pipeline[180] - The company is advancing a pipeline of vaccine candidates utilizing its CpG 1018 adjuvant, targeting indications with unmet medical needs, including shingles and plague[138] Debt and Financing - The company incurred a loss on debt extinguishment of $82.095 million during the nine months ended September 30, 2025[17] - The total principal balance of outstanding convertible notes as of September 30, 2025, was $265.2 million, comprising $225.0 million of 2030 Notes and $40.2 million of remaining 2026 Notes[70] - The company recognized a loss on debt extinguishment of $82.1 million related to the refinancing transaction completed on March 13, 2025[73] - The 2030 Notes had an aggregate principal amount of $225.0 million, with a fair value of $209.2 million, classified as a long-term liability[91] Stock and Equity - The company executed a share repurchase program allowing for the repurchase of up to $200.0 million worth of common stock, completing all repurchases by September 30, 2025[164] - The share repurchase program authorized by the Board of Directors allows for the repurchase of up to $200.0 million worth of common stock, with $100.0 million already executed through an accelerated share repurchase agreement[107][108] - During the nine months ended September 30, 2025, the company repurchased 8,135,637 shares of common stock for approximately $91.7 million through open market transactions[109] - The Amended 2018 Equity Incentive Plan has 8,583,472 shares of common stock reserved for issuance as of September 30, 2025[115] Taxation - The effective income tax rate for the nine months ended September 30, 2025, was 5.3%, a decrease from 12.8% in 2024[124] - The effective income tax rate for the nine months ended September 30, 2025, was 5.3%, compared to 11.2% for the same period in 2024, with differences driven by federal, state, and foreign tax expenses offset by net operating losses utilized[189] Market and Product Information - Dynavax's first marketed product, HEPLISAV-B, is approved in the U.S., EU, and UK for the prevention of hepatitis B virus infection in adults[28] - The market opportunity for the HEPLISAV-B hepatitis B vaccine is projected to reach approximately $900.0 million in the U.S. by 2030, with an expected market share of at least 60%[137] - The company is advancing a pipeline of vaccine candidates, including programs for shingles and a plague vaccine, funded by the U.S. Department of Defense[29]

Financial Performance - HEPLISAV-B® quarterly net product revenue reached $90 million, a 13% increase year-over-year from $79.3 million[12] - Total revenues for the third quarter of 2025 were $94.9 million, an 18% increase compared to $80.6 million for the same quarter in 2024[18] - Dynavax expects HEPLISAV-B net product revenue for the full year 2025 to be in the range of $315 to $325 million[18] - The company reported GAAP net income of $26.9 million, or $0.23 per share basic, compared to $17.6 million, or $0.13 per share basic in the third quarter of 2024[18] - Adjusted EBITDA for the third quarter of 2025 was $35.5 million, compared to $25 million for the same period in 2024[18] - Total revenues for the three months ended September 30, 2025, were $94.876 million, an increase of 17.5% compared to $80.630 million for the same period in 2024[41] - Product revenue for the three months ended September 30, 2025, was $89.954 million, up from $79.345 million in the prior year, reflecting a growth of 13.5%[41] - Adjusted EBITDA for the three months ended September 30, 2025, was $35.532 million, compared to $24.994 million for the same period in 2024, representing a year-over-year increase of 42.2%[44] - Net income for the three months ended September 30, 2025, was $26.927 million, compared to $17.594 million in the same period of 2024, marking a growth of 53.0%[41] Expenses and Liabilities - Research and development expenses for the third quarter of 2025 were $19.1 million, compared to $14.4 million in the same quarter of 2024[18] - Total current assets as of September 30, 2025, were $814.331 million, a decrease from $848.941 million as of December 31, 2024[43] - Total liabilities as of September 30, 2025, were $412.368 million, compared to $389.457 million as of December 31, 2024, indicating an increase of 5.9%[43] - Research and development expenses for the three months ended September 30, 2025, were $19.116 million, compared to $14.403 million in the same period of 2024, reflecting a 32.5% increase[41] - The company reported a loss on debt extinguishment of $82.095 million for the nine months ended September 30, 2025[44] Market Position and Strategic Initiatives - HEPLISAV-B's total estimated market share in the U.S. increased to approximately 46%, up from 44% in the third quarter of 2024[12] - Dynavax entered into an exclusive license agreement with Vaxart for its oral COVID-19 vaccine candidate, involving an upfront license fee of $25 million and potential additional payments totaling $50 million[6] - The company authorized a new $100 million share repurchase program, reflecting confidence in its future and commitment to capital allocation[7] - The company anticipates continued growth and strategic investments, including collaborations and market expansion opportunities beyond 2030[37] Cash and Securities - Cash, cash equivalents, and marketable securities totaled $647.8 million as of September 30, 2025, down from $713.8 million as of December 31, 2024[18] - Cash, cash equivalents, and marketable securities as of September 30, 2025, were $647.815 million, down from $713.834 million at the end of 2024, a decrease of 9.2%[43]

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 will report its third quarter 2025 financial results on November 5, 2025, after U.S. financial markets close [1] - A conference call and live audio webcast will be held on the same day at 4:30 p.m. ET/1:30 p.m. PT [1][2] 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® vaccine, approved in the U.S., EU, and UK for hepatitis B prevention in adults aged 18 and older, and CpG 1018® adjuvant, used in HEPLISAV-B and various adjuvanted COVID-19 vaccines [3]