Dynavax Technologies (DVAX) closed the last trading session at $13.33, gaining 4.6% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $24.25 indicates an 81.9% upside potential.The mean estimate comprises four short-term price targets with a standard deviation of $8.54. While the lowest estimate of $12 indicates a 10% decline from the current price level, the most optimistic analyst ...

Dynavax (DVAX) Q4 2024 Earnings Call February 21, 2025 12:04 AM ET Company Participants Paul Cox - VP of Investor Relations & Corporate CommunicationsRyan Spencer - CEODonn Casale - Chief Commercial OfficerRobert Janssen - Chief Medical Officer and Senior VP of Clinical Development, Medical & Regulatory AffairsKelly MacDonald - CFOMatt Phipps - Group Head - BiotechnologyJonathan Miller - Managing Director Conference Call Participants Roy Buchanan - Equity Research AnalystPhil Nadeau - Managing Director, Hea ...

Financial Data and Key Metrics Changes - Dynavax reported record HEPLISAV-B product revenue of $71 million for Q4 2024, up 39% year-over-year, and $268 million for the full year, up 26% year-over-year [16][33] - The gross margin for HEPLISAV-B was 82% for the full year 2024, an increase from 76% in 2023, achieving the guidance of approximately 80% for 2024 [34] - The company achieved net income of $27 million for the full year, including $7 million in Q4 [36] - Non-GAAP adjusted EBITDA for Q4 was $13 million, an increase of over 200% year-over-year, and $52 million for the full year, up over 300% compared to the prior year [37] Business Line Data and Key Metrics Changes - HEPLISAV-B's total market share increased to 44% by the end of 2024, driven by strong commercial execution [15] - The overall hepatitis B vaccine dose growth increased by nearly 10% year-over-year in 2024, with HEPLISAV-B's dose growing by 25% annually [16][17] - The market opportunity for HEPLISAV-B expanded by approximately $90 million to $650 million in 2024, with expectations to peak over $900 million by 2030 [22] Market Data and Key Metrics Changes - The inclusion of adult hepatitis B vaccination in the HEDIS measure is expected to enhance focus and utilization in integrated delivery networks (IDNs) and large clinics [20][21] - The new Medicare policy allows access to hepatitis B vaccines at retail pharmacies, which is anticipated to support HEPLISAV-B's growth in 2025 [19][104] Company Strategy and Development Direction - The company aims to drive continued top-line growth for HEPLISAV-B, with projected net product sales between $305 million to $325 million in 2025 [8][41] - Dynavax is focused on advancing its clinical pipeline, particularly the shingles vaccine program Z-1018, which is expected to establish a differentiated product profile [9][10] - The company plans to pursue external opportunities to generate sustainable long-term value for shareholders while maintaining a balanced capital allocation strategy [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in 2025 being a transformational year for the development pipeline, with multiple programs advancing to important milestones [8] - The company is optimistic about the ongoing adoption of HEPLISAV-B and the positive market dynamics that will support long-term revenue opportunities [18][21] - Management highlighted the importance of maintaining commercial efforts to sustain market share and drive growth [92] Other Important Information - The company exited 2024 with cash equivalents and marketable securities of $714 million, down from $742 million at the end of 2023, partly due to share repurchase activities [38][39] - Dynavax plans to complete the remaining $100 million of authorized share repurchases by the end of 2025 [39] Q&A Session Summary Question: What barriers need to be overcome to drive continued market share growth? - Management highlighted the importance of access in the Medicare patient population and the impact of the HEDIS measure on market share gains [48] Question: What is the expected non-inferiority level for the shingles program? - The company aims for a CD4 response rate of 75% or greater compared to Shingrix, considering both quantity and quality of T cell responses [54][56] Question: How will the company approach the Phase III study for shingles? - The design and timeline for the Phase III study are still under evaluation, with plans to leverage Phase I/II data for regulatory discussions [127] Question: What is the potential market size for the plague vaccine program? - The market size will depend on government assessments of biological threats, with current efforts focused on the DoD [130] Question: What is the company's appetite for additional buybacks? - Management indicated that while they are committed to the current buyback program, they will consider additional buybacks based on future performance and opportunities [76]

Earnings Performance - Dynavax Technologies reported quarterly earnings of $0.05 per share, exceeding the Zacks Consensus Estimate of $0.04 per share, compared to break-even earnings per share a year ago, representing an earnings surprise of 25% [1] - The company posted revenues of $72.03 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 0.46%, and showing an increase from year-ago revenues of $55.6 million [2] Stock Performance and Outlook - Dynavax Technologies shares have increased approximately 2.5% since the beginning of the year, while the S&P 500 has gained 4.5% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] Estimate Revisions and Rankings - The estimate revisions trend for Dynavax Technologies is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is $0.02 on revenues of $68.31 million, and for the current fiscal year, it is $0.32 on revenues of $329.34 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Dynavax Technologies belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]

Corporate Presentation Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases February 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 year and quarter ended December 31, 20 ...

Revenue and Market Performance - HEPLISAV-B product revenue for the year ended December 31, 2024, was $268.4 million, a 26% increase compared to 2023, driven by market share gains in the U.S.[29] - HEPLISAV-B's estimated total market share in the U.S. increased to approximately 44% at the end of 2024, up from 42% at the end of 2023[29] - 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[29] - Total revenues for 2024 were $277,246,000, an increase of 19.4% compared to $232,284,000 in 2023[444] - Product revenue, net for 2024 was $268,430,000, up from $213,295,000 in 2023, reflecting a growth of 25.9%[444] - The company aims to increase HEPLISAV-B market share and maximize its total addressable market based on CDC recommendations[34] Financial Performance - Cash generated from operating activities for the year ended December 31, 2024, was $66.5 million, with cash and cash equivalents totaling $713.8 million at year-end[29] - The net income for 2024 was $27,309,000, a significant recovery from a net loss of $6,389,000 in 2023[445] - Basic net income per share for 2024 was $0.21, compared to a loss of $0.05 per share in 2023[444] - Operating expenses increased to $281,368,000 in 2024 from $269,312,000 in 2023, representing a rise of 4.0%[444] - Total assets decreased to $986,256,000 in 2024 from $997,096,000 in 2023, a decline of 1.4%[442] - Total liabilities increased to $389,457,000 in 2024, up from $375,024,000 in 2023, marking a rise of 3.8%[442] - Stockholders' equity decreased to $596,799,000 in 2024 from $622,072,000 in 2023, a decrease of 4.1%[442] - Cash and cash equivalents decreased to $95,883,000 in 2024 from $150,279,000 in 2023, a decline of 36.2%[442] Research and Development - The company is conducting a Phase 1/2 trial for the Z-1018 shingles vaccine, with top-line data expected in the third quarter of 2025[30] - The company is developing a four-dose HEPLISAV-B regimen for adults on hemodialysis, with FDA feedback received for a potential observational study[31] - The company is advancing a pipeline of vaccine candidates, including those for shingles and a plague vaccine, funded by the U.S. Department of Defense[455] - A Phase 1/2 clinical trial for the shingles vaccine candidate Z-1018 was initiated in June 2024, enrolling approximately 440 healthy adults aged 50 to 69[46] Regulatory and Compliance - The regulatory process for biopharmaceuticals involves extensive requirements, including submission of an IND and compliance with FDA regulations[73] - The FDA aims to review applications within ten months, or eight months for serious unmet medical needs[80] - A Complete Response Letter may require additional clinical data and/or trials, which can be significant and time-consuming[80] - Non-compliance with FDA regulations can lead to severe consequences, including product recalls and legal actions[81] - The EU requires compliance with GMP standards for the manufacture of medicinal products, including active pharmaceutical ingredients[100] Intellectual Property - The intellectual property portfolio includes over 20 issued U.S. patents and over 45 granted foreign patents, with a focus on vaccines and adjuvants[59] - The patent estate is projected to expire between 2025 and 2044, depending on the specific patents and applications[61] Competition and Market Challenges - The company faces significant competition in the vaccine and adjuvant market from larger firms with greater financial resources and expertise[72] - The company is exploring additional territories outside the U.S., EU, and UK for marketing HEPLISAV-B, facing potential competition in these markets[70] Employee and Workplace Culture - As of December 31, 2024, the company had 405 employees, with 260 in the U.S. and 145 in Düsseldorf, Germany[144] - The regrettable turnover rate for 2024 was 6% in the U.S. and 5% in Düsseldorf, indicating strong employee retention[145] - The average tenure among employees is 3.7 years in the U.S. and 6.1 years in Düsseldorf, reflecting stability in the workforce[146] - The company was certified as a Great Place To Work for the second consecutive year, indicating strong workplace culture[150] - The company’s employee development programs included 29 leaders completing a leadership development program in 2024, emphasizing commitment to talent development[148] Supply Chain and Manufacturing - The company relies on a limited number of suppliers for manufacturing, including a single supplier for the CpG 1018 adjuvant, which poses risks to supply chain stability[139] - The company has secured long-term supply agreements with key third-party suppliers to ensure the commercial supply of component products and finished goods[139] Financial Management and Investment - The company does not expect material loss with respect to its investment portfolio, maintaining a conservative investment strategy[425] - The company has not used derivative financial instruments for speculation or trading purposes, maintaining a conservative risk management approach[426] - The company’s investment portfolio is primarily in cash equivalents and highly liquid investments, minimizing interest rate risk[424]

[FORM 8-K Filing Information](index=1&type=section&id=FORM%208-K%20Filing%20Information) This section provides essential details regarding the Form 8-K filing, including registrant identification, report date, and filing type [Registrant and Filing Details](index=1&type=section&id=Registrant%20and%20Filing%20Details) This section identifies Dynavax Technologies Corporation as the registrant, detailing the Form 8-K filing date and type - Registrant: **Dynavax Technologies Corporation**[2](index=2&type=chunk) - Date of Report: **January 13, 2025**[2](index=2&type=chunk) - Filing Type: **Current Report on Form 8-K**[1](index=1&type=chunk) [Securities Registered and Emerging Growth Status](index=2&type=section&id=Securities%20Registered%20and%20Emerging%20Growth%20Status) This section lists the company's registered securities on Nasdaq and confirms Dynavax is not an emerging growth company | Title of each class | Symbol(s) | Name of each exchange on which registered | |---|---|---| | Common Stock, $0.001 par value | DVAX | Nasdaq Global Select Market | | Preferred Share Purchase Rights | N/A | Nasdaq Global Select Market | - Registrant is not an emerging growth company[6](index=6&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Dynavax announced preliminary unaudited Q4 and full year 2024 financial highlights, subject to final audit - Dynavax issued a press release on January 13, 2025, announcing preliminary unaudited fourth quarter and full year 2024 financial highlights[7](index=7&type=chunk) - The preliminary financial results are based on estimates and are subject to change upon completion of the financial close process and audit[8](index=8&type=chunk) - The press release (Exhibit 99.1) is incorporated by reference[7](index=7&type=chunk) [Item 7.01 Regulation FD Disclosure](index=3&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure) The company posted an Investor Presentation and clarified that furnished information is not 'filed' for liability purposes - Dynavax posted an Investor Presentation (Exhibit 99.2) on its website under the 'News & Events' tab[9](index=9&type=chunk) - The information in this Form 8-K and its exhibits is furnished, not 'filed,' and is not subject to certain liability provisions of the Securities Exchange Act of 1934 or Securities Act of 1933[10](index=10&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the Form 8-K exhibits, including a press release with financial highlights and an investor presentation | Exhibit No. | Description | |---|---| | 99.1 | Press release dated January 13, 2025 titled "Dynavax Announces Preliminary Unaudited Fourth Quarter and Full Year 2024 Financial Highlights." | | 99.2 | Dynavax Investor Presentation. | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=4&type=section&id=Signatures) This section confirms the report's due signing by an authorized officer of Dynavax Technologies Corporation - The report was signed by Kelly MacDonald, Senior Vice President, CFO, on January 13, 2025[14](index=14&type=chunk)

Core Insights - Dynavax Technologies Corporation reported strong financial results for Q4 and full year 2024, with significant growth in HEPLISAV-B product revenue and a positive outlook for 2025 [2][7][8]. Business Updates - HEPLISAV-B is the first and only adult hepatitis B vaccine approved in the U.S., EU, and UK, allowing series completion with just two doses [3]. - The company is advancing its clinical pipeline, including a shingles vaccine (Z-1018) and a plague vaccine candidate, with significant funding from the U.S. Department of Defense [4][5][6]. Financial Performance - HEPLISAV-B net product revenue for 2024 reached $268.4 million, a 26% increase from $213.3 million in 2023 [8]. - Total revenues for 2024 were $277.2 million, up 19% from $232.3 million in 2023 [15]. - The company reported a GAAP net income of $27.3 million for 2024, compared to a net loss of $6.4 million in 2023 [15]. Future Guidance - For 2025, Dynavax expects HEPLISAV-B net product revenue to be between $305 million and $325 million [7][13]. - The company anticipates reporting top-line results from the shingles vaccine Phase 1/2 trial in Q3 2025 and plans to initiate a Phase 2 trial for the plague vaccine in the same quarter [7][9]. Market Position - HEPLISAV-B's market share in the U.S. increased to approximately 44% by the end of 2024, with expectations to reach at least 60% as the hepatitis B adult vaccine market is projected to exceed $900 million by 2030 [8].

Core Viewpoint - Dynavax Technologies Corporation is committed to enhancing long-term stockholder value through strategic initiatives and board changes, while facing challenges from Deep Track Capital regarding board nominations and company strategy [1][5][9]. Financial Performance - Dynavax has executed a disciplined capital allocation strategy, including a $200 million share repurchase plan initiated in November 2024, with $100 million already executed through an accelerated program [2]. - The company reported record HEPLISAV-B annual revenue in 2024, achieving a 26% year-over-year growth, and aims for at least 60% total market share by 2030 [6]. Board Changes - The Board of Directors has begun a refreshment process since August 2024, resulting in the appointment of two independent directors and the planned resignation of two current directors at the 2025 Annual Meeting [3][4]. - Following the 2025 Annual Meeting, the Board will consist of nine directors, with six of the eight independent directors appointed since 2020 [4]. Engagement with Deep Track - Dynavax has engaged extensively with Deep Track, but the latter's proposed strategy has been deemed flawed and potentially harmful to the company's long-term growth [5][7]. - Deep Track's insistence on controlling the Board without a control premium has led to a breakdown in negotiations, despite Dynavax's attempts to reach a reasonable settlement [9][13]. Strategic Initiatives - Dynavax is advancing a differentiated vaccine pipeline, including a novel shingles vaccine program and a $30 million contract with the U.S. Department of Defense for its plague vaccine program [6]. - The company maintains a strong financial profile with a balance sheet of $714 million as of year-end 2024, positioning it well for future growth and strategic acquisitions [6].

Core Viewpoint - Goldman Sachs downgraded Dynavax Technologies Corporation from Neutral to Sell, reducing the price target from $15 to $12 due to increased competition in the shingles vaccine market, which may diminish the potential value of the Z-1018 program and create uncertainty regarding long-term revenue [1] Group 1: Competitive Landscape - GSK's Shingrix, featuring pre-filled syringes, is under review by the FDA and EMA, with a U.S. decision expected by June 20 [2] - Dynavax is conducting a Phase 1/2 trial to assess the safety, tolerability, and immunogenicity of Z-1018 against GSK's Shingrix in 441 healthy adults aged 50 to 69 [2] Group 2: Financial Performance - Dynavax reported preliminary HEPLISAV-B net product revenue of $268 million for 2024, reflecting a 26% year-over-year increase [3] - HEPLISAV-B net product revenue for Q4 2024 reached $71 million, up 39% [3] - Analysts estimate Q4 adjusted EPS of $0.04 and sales of $72.92 million, with 2024 sales forecasted at $278.13 million and adjusted EPS of $0.12 [4] Group 3: Regulatory Challenges - The FDA issued a Complete Response Letter in May 2024, indicating that the application for a four-dose regimen of HEPLISAV-B lacked sufficient data for a full evaluation of effectiveness or safety [4]