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Dynavax Technologies Corporation (Nasdaq: DVAX) is a prominent clinical-stage biopharmaceutical firm dedicated to developing innovative vaccines targeting infectious and inflammatory diseases, as well as cancer. With its headquarters in Emeryville, California, the company is renowned for leveraging the body's innate and adaptive immune responses through its proprietary Toll-like Receptor Immune Modulation Platform technology.
Core Products and Clinical Pipeline:
- HEPLISAV-B®: Approved in the U.S., EU, and Great Britain, HEPLISAV-B is the first and only adult hepatitis B vaccine that allows series completion with just two doses in one month. It continues to show strong market expansion and revenue growth.
- CpG 1018® Adjuvant: An essential component in multiple adjuvanted COVID-19 vaccines, this adjuvant enhances the immune response.
- Shingles Vaccine Program (Z-1018): In development for preventing shingles in adults aged 50 and older, promising robust immune responses.
- Tdap Vaccine Program (Tdap-1018): Focused on active booster immunization against tetanus, diphtheria, and pertussis.
- Plague Vaccine Program (DV2-PLG-01): In Phase 2 clinical trials, this program is fully funded by the U.S. Department of Defense.
Recent Achievements and Financial Highlights:
- Dynavax reported record revenue growth for HEPLISAV-B in 2023, capturing significant market share in the adult hepatitis B vaccine sector.
- As of December 31, 2023, the company had cash, cash equivalents, and marketable securities worth $742.3 million, underpinning its strong financial foundation.
- For the first quarter of 2024, Dynavax's net loss was reduced compared to the same period in 2023, due to improved operational efficiencies and strategic market initiatives.
Strategic Partnerships:
Collaborations with global biopharmaceutical companies, including AstraZeneca in Europe, further strengthen Dynavax's market position and broaden its product reach.
For detailed financial information and ongoing updates, investors can access the company's Events & Presentations page on their official website.
Dynavax Technologies (DVAX) reported strong financial results for Q4 and full year 2024, with HEPLISAV-B net product revenue growing 26% year-over-year to $268.4 million. The company's Q4 revenue reached $71.1 million, up 39% from the previous year.
Key highlights include:
- HEPLISAV-B U.S. market share increased to 44% by end of 2024
- Full year 2024 GAAP net income of $27.3 million ($0.21 per share)
- Cash position of $713.8 million as of December 31, 2024
- Adjusted EBITDA of $51.9 million for 2024, up 329% year-over-year
For 2025, Dynavax expects HEPLISAV-B net product revenue between $305-325 million and adjusted EBITDA of at least $75 million. The company plans to complete its $200 million share repurchase program and anticipates top-line results from its Phase 1/2 shingles vaccine trial in Q3 2025.
Dynavax Technologies (DVAX) has responded to Deep Track Capital's nomination of four board candidates, highlighting its strong execution and value creation strategy. The company reported record HEPLISAV-B revenue in 2024 with 26% year-over-year growth and expects to achieve 60% market share by 2030.
The company maintains a strong financial position with $714 million in cash as of year-end 2024 and has implemented a $200 million share repurchase plan, with $100 million already executed through an accelerated program. Dynavax recently secured a $30 million contract with the U.S. Department of Defense for its plague vaccine program and is advancing its shingles vaccine program.
The board has initiated refreshment changes, including appointing two new independent directors and planning board declassification. Despite multiple settlement attempts with Deep Track, negotiations have been unsuccessful, with Deep Track seeking board control without paying a control premium.
Dynavax Technologies (Nasdaq: DVAX), a commercial-stage biopharmaceutical company focused on vaccine development, has scheduled its fourth quarter and full year 2024 financial results announcement for February 20, 2025, after U.S. market close. The company will host a conference call and webcast at 4:30 p.m. ET/1:30 p.m. PT on the same day.
Dynavax currently markets two commercial products: HEPLISAV-B vaccine, approved in the U.S., EU, and Great Britain for hepatitis B virus prevention in adults 18 and older, and CpG 1018 adjuvant, used in HEPLISAV-B and various COVID-19 vaccines.
Dynavax Technologies (DVAX) announced significant board changes as part of its ongoing refreshment program. Emilio Emini, Ph.D. and Lauren Silvernail will join the Board effective February 3, 2025. Two current directors, Peggy Phillips and Julie Eastland, will step down at the 2025 Annual Meeting.
The company plans to seek stockholder approval for Board declassification at the 2025 Annual Meeting. If approved, directors will transition to one-year terms starting from the 2026 Annual Meeting, with all directors standing for annual election by 2028.
The company reported strong performance, achieving record annual revenue for HEPLISAV-B in 2024 and maintaining an active $200 million share repurchase program. Following the 2025 Annual Meeting, the Board will consist of nine directors, with six of its eight independent directors appointed since 2020.
Dynavax Technologies (DVAX) reported preliminary unaudited financial highlights for Q4 and full year 2024. HEPLISAV-B achieved record annual revenue of $268 million, representing 26% growth year-over-year, and Q4 revenue of $71 million, up 39% from Q4 2023.
The company expects the U.S. hepatitis B adult vaccine market to reach over $900 million in annual sales by 2030, with HEPLISAV-B targeting at least 60% market share. The company completed enrollment in its Phase 1/2 shingles vaccine trial, with top-line results expected in Q3 2025. Additionally, Dynavax secured a new $30 million contract with the U.S. Department of Defense for plague vaccine development.
As of December 31, 2024, the company reported approximately $714 million in cash, cash equivalents, and marketable securities.
Dynavax Technologies (Nasdaq: DVAX), a commercial-stage biopharmaceutical company focused on innovative vaccine development, has announced its upcoming participation at the 7th Annual Evercore HealthCONx Conference. The presentation is scheduled for Tuesday, December 3 at 2:35 p.m. ET.
Interested parties can access the webcast through the 'Events & Presentations' section on the company's investor relations website at investors.dynavax.com/events-presentations.
Dynavax Technologies has announced a $100 million Accelerated Share Repurchase (ASR) program under an agreement with Goldman Sachs & Co. . This ASR is part of a $200 million share repurchase program authorized by Dynavax's Board of Directors in November 2024. Upon completion, $100 million will remain in the program.
Dynavax will initially receive approximately 6.1 million shares, representing around 80% of the $100 million paid, based on the $13.01 closing stock price on November 8, 2021. The final number of shares repurchased will be determined by the volume-weighted average prices during the ASR term, with final settlement expected in Q1 2025. As of November 5, 2024, Dynavax had about 131.5 million shares outstanding.
Chief Financial Officer Kelly MacDonald stated that the ASR reflects confidence in Dynavax's business and commitment to shareholder value through strategic capital allocation.
Dynavax (DVAX) reported strong Q3 2024 financial results, with HEPLISAV-B achieving record quarterly net product revenue of $79.3 million, up 27% year-over-year. The company's total revenues reached $80.6 million, a 16% increase from Q3 2023. HEPLISAV-B's U.S. market share grew to 44%, with particularly strong performance in retail pharmacy (55%) and IDN segments (56%). The company expects the hepatitis B adult vaccine market to reach over $900 million by 2030, with HEPLISAV-B targeting at least 60% market share. Dynavax reported net income of $17.6 million and maintains a strong cash position of $764 million. The company also announced a $200 million share repurchase program and discontinued its Tdap-1018 development program.
Dynavax Technologies (Nasdaq: DVAX) has announced a new $200 million share repurchase program with no expiration date, expected to be executed within one year. The company's management will determine the timing and amount of repurchases based on business capital needs, stock price, and market conditions. The program can be implemented through various methods including open market purchases and block trades, and can be suspended at any time. CFO Kelly MacDonald emphasized this aligns with their disciplined capital allocation approach, aiming to create shareholder value while maintaining flexibility for HEPLISAV-B development, research pipeline advancement, and portfolio expansion.
Dynavax Technologies (DVAX) has implemented a -duration stockholder rights plan in response to Deep Track Capital's recent accumulation of 13.6% of company stock. The plan grants stockholders one preferred share purchase right per common share as of November 8, 2024. Rights become exercisable if any entity acquires 15% ownership (18% for passive institutional investors), allowing holders to purchase additional shares at $52.00. The plan aims to protect stockholder value and prevent control acquisition without appropriate premium. The Rights Plan will be submitted for stockholder vote at the 2025 Annual Meeting and will expire thereafter unless ratified, in which case it continues until October 28, 2025.