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Dynavax Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Full Year 2025 Financial Guidance
Prnewswire· 2025-02-20 21:01
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].
Dynavax Responds to Deep Track and Highlights Long-Term Value Creation Strategy
Prnewswire· 2025-02-19 21:52
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].
Goldman Sachs Turns Bearish On Vaccine Maker Dynavax Amid Shingles And Hepatitis B Uncertainty
Benzinga· 2025-02-11 20:11
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]
Dynavax to Report Fourth Quarter and Full Year 2024 Financial Results and Host Conference Call on February 20, 2025
Prnewswire· 2025-02-06 22:42
EMERYVILLE, Calif., Feb. 6, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report fourth quarter and full year 2024 financial results on Thursday, February 20, 2025, after the U.S. financial markets close. Dynavax will host a conference call and live audio webcast on Thursday, February 20, 2025, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & ...
Wall Street Analysts Believe Dynavax Technologies (DVAX) Could Rally 93.2%: Here's is How to Trade
ZACKS· 2025-01-29 15:55
Shares of Dynavax Technologies (DVAX) have gained 1.3% over the past four weeks to close the last trading session at $12.94, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $25 indicates a potential upside of 93.2%.The average comprises four short-term price targets ranging from a low of $15 to a high of $31, with a standard deviation of $7.12. While the lowest estimate indicate ...
Dynavax Advances Board Refreshment Program
Prnewswire· 2025-01-27 11:00
Appoints Emilio Emini and Lauren Silvernail to Board of Directors; Two Directors to Step Down at 2025 Annual Meeting Intends to Seek Stockholder Approval for Declassification of Board at 2025 Annual Meeting EMERYVILLE, Calif., Jan. 27, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) (the "Company"), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced the following changes to its Board of Directors as part of its ongoing refres ...
Dynavax Technologies (DVAX) Upgraded to Buy: Here's What You Should Know
ZACKS· 2025-01-16 18:00
Core Viewpoint - Dynavax Technologies (DVAX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the importance of earnings estimate revisions, which have shown a strong correlation with near-term stock price movements [4][6]. - For the fiscal year ending December 2024, Dynavax is expected to earn $0.20 per share, reflecting a 500% increase from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Dynavax has risen by 19.8%, indicating a positive trend in earnings expectations [8]. Institutional Investor Influence - Institutional investors play a role in stock price movements by adjusting their valuations based on earnings estimates, leading to buying or selling actions that affect stock prices [4][5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - The upgrade of Dynavax to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].
Dynavax Announces Preliminary Unaudited Fourth Quarter and Full Year 2024 Financial Highlights
Prnewswire· 2025-01-13 14:00
Preliminary 2024 HEPLISAV-B® net product revenue grew 26% year-over-year to approximately $268 million Enrollment completed in Phase 1/2 shingles trial; top line results expected in Q3 2025 New $30 million contract with U.S. Department of Defense to advance plague vaccine program Cash, cash equivalents and marketable securities were approximately $714 million as of December 31, 2024EMERYVILLE, Calif., Jan. 13, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharm ...
Does Dynavax Technologies (DVAX) Have the Potential to Rally 93.52% as Wall Street Analysts Expect?
ZACKS· 2024-11-27 16:00
Shares of Dynavax Technologies (DVAX) have gained 7.2% over the past four weeks to close the last trading session at $12.66, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $24.50 indicates a potential upside of 93.5%.The mean estimate comprises four short-term price targets with a standard deviation of $6.61. While the lowest estimate of $15 indicates an 18.5% increase from the ...
Dynavax to Present at the 7th Annual Evercore HealthCONx Conference
Prnewswire· 2024-11-26 21:05
EMERYVILLE, Calif., Nov. 26, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at the 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 at 2:35 p.m. ET.The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/ev ...