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 ...

Dynavax Technologies Corporation (NASDAQ:DVAX) Q4 2024 Earnings Conference Call February 20, 2025 4:30 PM ET Company Participants Paul Cox - Vice President, Investor Relations & Corporate Communications Ryan Spencer - Chief Executive Officer Donn Casale - Chief Commercial Officer Rob Janssen - Chief Medical Officer Kelly MacDonald - Chief Financial Officer Conference Call Participants Matt Phipps - William Blair Roy Buchanan - Citizens Jonathan Miller - Evercore ISI Phil Nadeau - TD Cowen Ed White - H.C. Wa ...

Dynavax Technologies (DVAX) came out with quarterly earnings of $0.05 per share, beating the Zacks Consensus Estimate of $0.04 per share. This compares to break-even earnings per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 25%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.10 per share when it actually produced earnings of $0.12, delivering a surprise of 20%.Over the last four qua ...

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]

CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K ______________________________________________________ Date of Report (Date of earliest event reported): January 13, 2025 Dynavax Technologies Corporation (Exact name of Registrant as Specified in Its Charter) ______________________________________________________ (State or Other Jurisdiction of Incorporation) Delaware 001-34207 33-0728374 (Co ...

HEPLISAV-B® 2024 net product revenue grew 26% year-over-year to $268 million; net product revenue expected to be $305 to $325 million in 2025 Top-line results in Phase 1/2 shingles trial expected in Q3 2025 Plan to initiate Phase 2 trial for plague vaccine in Q3 2025 Expect completion of $200 million share repurchase program in 2025 Conference call today at 4:30 p.m. ET/1:30 p.m. PT EMERYVILLE, Calif., Feb. 20, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopha ...

Reiterates Meaningful Board Change Already Underway EMERYVILLE, Calif., Feb. 19, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) ("Dynavax" or the "Company"), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today issued a statement underscoring continued execution momentum and commitment to driving long-term stockholder value. The Company also confirmed that Deep Track Capital ("Deep Track") has submitted a letter purporting to nominate f ...

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]