1. Dynavax reported record HEPLISAV-B revenue for Q1 2025. 2. They reaffirmed their 2025 financial guidance with growth expectations. 3. Strong focus on advancing vaccine pipeline, including shingles and plague vaccines. 4. Share repurchase program execution at over 85% completed. 5. Challenges noted include significant net loss and operational expenses.
Strong revenue and guidance reaffirms confidence, similar to previous successful quarters.
Strong revenue and continued pipeline development indicate potential growth for DVAX.
Immediate impact expected from Q1 results and market expectations for HEPLISAV-B.
EMERYVILLE, Calif., May 6, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results and provided a business update for the quarter ended March 31, 2025.
"We started 2025 off strong, executing across our strategic growth initiatives, including delivering our highest first quarter net product revenue for HEPLISAV-B to date, putting us on track to achieve the top half of our full year guidance range. We are also excited to advance our pipeline leveraging our leading vaccine adjuvant technology, CpG 1018, with key clinical trial milestones this year for our shingles and plague vaccine programs, while further broadening our pipeline with new programs in pandemic influenza and Lyme disease," said Ryan Spencer, Chief Executive Officer of Dynavax.
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and the United Kingdom that enables series completion with only two doses in one month. In the U.S., hepatitis B vaccination is recommended for adults aged 19 to 59, and for adults aged 60 and older with risk factors, while adults aged 60 and older without known risk factors may also be vaccinated.
Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018® adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.
Dynavax is reaffirming its full year 2025 financial guidance, based on its current operating plan:
* Non-GAAP financial measure. Please refer to the "Non-GAAP Financial Measures" section for details regarding this measure.
Dynavax will host a conference call and live audio webcast on Tuesday, May 6, 2025, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of Dynavax's website at https://investors.dynavax.com/events-presentations. A replay of the webcast will be available for 30 days following the live event.
HEPLISAV-B is a shot given to adults 18 years of age and older to help prevent infection caused by the hepatitis B virus. HEPLISAV-B is usually given in the arm muscle. HEPLISAV-B is given in 2 doses, 1 month apart, by a healthcare provider.
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).
There are no adequate and well-controlled studies of HEPLISAV-B in pregnant individuals. Available data do not suggest an increased risk of major birth defects and miscarriage.
It is not known whether HEPLISAV-B is excreted in human milk.
Vaccination with HEPLISAV-B may not result in protection of all vaccine recipients. Talk to your healthcare provider to determine if HEPLISAV-B is right for you. Please see full Prescribing Information.
Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. Dynavax has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and the United Kingdom for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about Dynavax's marketed products and development pipeline, visit www.dynavax.com.
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Dynavax's business.
For Investors/Media:
Paul Cox
pc@dynavax.com
510-665-0499
Nicole Arndt
na@dynavax.com
510-665-7264