Dynavax Announces Preliminary Unaudited Fourth Quarter and Full Year 2024 Financial Highlights
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 (DVAX) ha riportato i risultati preliminari finanziari non verificati per il quarto trimestre e l'intero anno 2024. HEPLISAV-B ha raggiunto un fatturato annuo record di 268 milioni di dollari, con una crescita del 26% rispetto all'anno precedente, e un fatturato nel quarto trimestre di 71 milioni di dollari, in aumento del 39% rispetto al quarto trimestre del 2023.
L'azienda prevede che il mercato dei vaccini per l'epatite B per adulti negli Stati Uniti raggiunga oltre 900 milioni di dollari in vendite annuali entro il 2030, con HEPLISAV-B che mira ad una quota di mercato di almeno il 60%. L'azienda ha completato l'arruolamento nella sperimentazione del vaccino contro il fuoco di Sant'Antonio di fase 1/2, con risultati principali attesi nel terzo trimestre del 2025. Inoltre, Dynavax ha ottenuto un nuovo contratto di 30 milioni di dollari con il Dipartimento della Difesa degli Stati Uniti per lo sviluppo di un vaccino contro la peste.
Il 31 dicembre 2024, l'azienda ha riportato circa 714 milioni di dollari in disponibilità liquide, equivalenti di cassa e titoli di mercato.
Dynavax Technologies (DVAX) informó los resultados financieros preliminares no auditados para el cuarto trimestre y el año completo 2024. HEPLISAV-B logró un ingreso anual récord de 268 millones de dólares, representando un crecimiento del 26% interanual, y un ingreso del cuarto trimestre de 71 millones de dólares, un aumento del 39% con respecto al cuarto trimestre de 2023.
La compañía espera que el mercado de la vacuna contra la hepatitis B para adultos en EE.UU. alcance más de 900 millones de dólares en ventas anuales para 2030, con HEPLISAV-B apuntando a al menos un 60% de cuota de mercado. La empresa completó la inscripción en su ensayo clínico de fase 1/2 para la vacuna contra el herpes zóster, esperando resultados principales en el tercer trimestre de 2025. Además, Dynavax aseguró un nuevo contrato de 30 millones de dólares con el Departamento de Defensa de EE.UU. para el desarrollo de una vacuna contra la peste.
Al 31 de diciembre de 2024, la compañía reportó aproximadamente 714 millones de dólares en efectivo, equivalentes de efectivo y valores negociables.
다이나벡스 테크놀로지스 (DVAX)는 2024년 4분기 및 연간 예비 감사되지 않은 재무 하이라이트를 발표했습니다. HEPLISAV-B는 연간 매출 2억 6천8백만 달러의 기록을 세우며, 전년 대비 26% 성장하였고, 4분기 매출은 7천1백만 달러로 2023년 4분기 대비 39% 증가했습니다.
회사는 미국의 성인 B형 간염 백신 시장이 2030년까지 연간 판매 9억 달러를 넘어설 것으로 예상하며, HEPLISAV-B가 최소 60%의 시장 점유율을 목표로 하고 있습니다. 이 회사는 대상포진 백신 임상 시험 Phase 1/2에 대한 등록을 완료했으며, 주요 결과는 2025년 3분기에 예상됩니다. 또한, 다이나벡스는 미국 국방부와 3천만 달러의 새로운 계약을 체결하여 페스트 백신 개발을 진행하고 있습니다.
2024년 12월 31일 현재, 회사는 약 7억 1천4백만 달러의 현금, 현금성 자산 및 시장성 증권을 보고했습니다.
Dynavax Technologies (DVAX) a annoncé ses résultats financiers préliminaires non audités pour le quatrième trimestre et l'année entière 2024. HEPLISAV-B a atteint un chiffre d'affaires annuel record de 268 millions de dollars, représentant une croissance de 26 % par rapport à l'année précédente, et un chiffre d'affaires au quatrième trimestre de 71 millions de dollars, en hausse de 39 % par rapport au quatrième trimestre 2023.
L'entreprise s'attend à ce que le marché des vaccins pour adultes contre l'hépatite B aux États-Unis atteigne plus de 900 millions de dollars de ventes annuelles d'ici 2030, avec HEPLISAV-B visant au moins 60 % de part de marché. L'entreprise a terminé l'inscription à son essai de vaccin contre le zona de phase 1/2, avec des résultats principaux attendus au troisième trimestre 2025. De plus, Dynavax a sécurisé un nouveau contrat de 30 millions de dollars avec le ministère de la Défense américain pour le développement d'un vaccin contre la peste.
Au 31 décembre 2024, l'entreprise a rapporté environ 714 millions de dollars en liquidités, équivalents de liquidités et titres négociables.
Dynavax Technologies (DVAX) berichtete über vorläufige, ungeprüfte finanzielle Höhepunkte für das vierte Quartal und das gesamte Jahr 2024. HEPLISAV-B erzielte einen Rekordjahresumsatz von 268 Millionen US-Dollar, was einem Wachstum von 26 % im Vergleich zum Vorjahr entspricht, und einen Umsatz im vierten Quartal von 71 Millionen US-Dollar, was einem Anstieg von 39 % gegenüber dem vierten Quartal 2023 entspricht.
Das Unternehmen erwartet, dass der Markt für die Hepatitis-B-Impfung bei Erwachsenen in den USA bis 2030 einen Jahresumsatz von über 900 Millionen US-Dollar erreichen wird, wobei HEPLISAV-B eine Marktanteil von mindestens 60 % anstrebt. Das Unternehmen hat die Einschreibung in seine Phase 1/2-Studie zum Shingles-Impfstoff abgeschlossen, und die zentralen Ergebnisse werden für das dritte Quartal 2025 erwartet. Darüber hinaus sicherte sich Dynavax einen neuen Vertrag über 30 Millionen US-Dollar mit dem US-Verteidigungsministerium zur Entwicklung eines Pestimpfstoffs.
Am 31. Dezember 2024 berichtete das Unternehmen über etwa 714 Millionen US-Dollar an Barausgaben, Bargeldäquivalenten und marktfähigen Wertpapieren.
- HEPLISAV-B revenue grew 26% YoY to $268 million in 2024
- Q4 2024 revenue increased 39% YoY to $71 million
- Strong cash position of $714 million
- New $30 million DoD contract for plague vaccine development
- Expected market expansion to $900 million by 2030 with 60% target market share
- None.
Insights
The preliminary financial results showcase remarkable commercial execution. HEPLISAV-B's revenue growth of
The robust cash position of
The completion of enrollment in the Phase 1/2 shingles vaccine trial represents a strategic expansion into a lucrative market segment. The comparative study against Shingrix® in 441 adults could position Dynavax to compete in the shingles vaccine space, currently dominated by GSK's blockbuster. The development of a four-dose HEPLISAV-B regimen for hemodialysis patients demonstrates market expansion efforts into specialized populations with higher infection risks.
The plague vaccine program's progression, backed by DoD funding, validates the versatility of the CpG 1018® adjuvant platform. This technology's proven enhancement of immune responses across multiple vaccines strengthens Dynavax's position in vaccine development.
HEPLISAV-B's market dynamics present compelling growth drivers:
- Universal recommendation for adults 19-59 in the U.S.
- Two-dose advantage over competitors' three-dose regimens
- Expanding eligible population through ongoing penetration
- Healthcare provider revaccination practices
- 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 U.S. Department of Defense to advance plague vaccine program - Cash, cash equivalents and marketable securities were approximately
$714 million
"We are excited to announce that HEPLISAV-B has achieved record annual revenue in 2024, reflecting
Business Updates and Upcoming Milestones
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the
- HEPLISAV-B achieved preliminary net product revenue of
$268 million 26% compared to$213 million - HEPLISAV-B achieved preliminary quarterly net product revenue of
$71 million 39% compared to$51 million - Dynavax continues to expect the hepatitis B adult vaccine market in the
U.S. to expand to a peak of over$900 million 60% total market share. Additionally, Dynavax believes the HEPLISAV-B U.S. market opportunity will remain substantial beyond 2030 due to the ongoing penetration of the unvaccinated eligible adult population, observed revaccination practices by healthcare providers, and continued gains in market share.
The preliminary selected financial results contained herein are unaudited, subject to adjustment, and provided as an estimate in advance of the Company's announcement of complete financial results, for the three and twelve months ended December 31, 2024.
Clinical Pipeline
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.
HEPLISAV-B for Adults on Hemodialysis:
Dynavax is developing a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis.
- In the fourth quarter of 2024, Dynavax received feedback from the FDA regarding the potential to conduct an observational retrospective cohort study to support its sBLA filing for adults on hemodialysis.
Shingles vaccine program:
Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 years and older.
- Dynavax is currently conducting a randomized, active-controlled, dose escalation, multicenter Phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix® in 441 healthy adults aged 50 to 69.
- In the fourth quarter of 2024, the Company completed enrollment in the trial, and Dynavax anticipates reporting top line immunogenicity and safety data in the third quarter of 2025.
Plague vaccine program:
Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018® in collaboration with, and fully funded by, the
- Based on the results from a randomized, active-controlled Phase 2 clinical trial of the plague vaccine adjuvanted with CpG 1018, Dynavax and the DoD executed a new agreement for approximately
$30 million
WHAT IS HEPLISAV-B?
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.
IMPORTANT SAFETY INFORMATION
If you have a history of severe allergic reaction after a previous dose of any hepatitis B vaccine, or to any ingredient of HEPLISAV-B, including yeast, do not take HEPLISAV-B.
HEPLISAV-B must be given by a medical professional, who will monitor you afterwards, to check for allergic reaction.
If you are immunocompromised, or receiving immunosuppressant therapy, you may have less of an immune response to HEPLISAV-B.
Some people have hepatitis B infection without being aware of it or showing any symptoms. If you already have hepatitis B present in your body, HEPLISAV-B may not prevent hepatitis B infection.
The most common side effects include pain at the injection site, tiredness, and headache.
HEPLISAV-B was not studied in pregnant or nursing women. Tell your provider if you are pregnant or plan to become pregnant or are breast feeding.
Vaccination with HEPLISAV-B may not protect all individuals.
Talk to your healthcare provider to determine if HEPLISAV-B is right for you.
Please see full Prescribing Information
About Dynavax
Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the
Forward-Looking Statements
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. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "toward," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding our expected financial results for the year ended December 31, 2024, expectations regarding our future growth and long-term performance, extent and timing of market growth and market share beyond 2030, the timing of IND filings, initiation and completion of clinical studies, expected timing for data readouts, and interaction with regulators. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that market size or actual demand for our products may differ from our expectations, risks relating to our ability to commercialize and supply HEPLISAV-B, risks related to the timing of completion and results of current clinical studies, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018 adjuvant, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended September 30, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the
Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the
For Investors/Media:
Paul Cox
pcox@dynavax.com
510-665-0499
Nicole Arndt
narndt@dynavax.com
510-665-7264
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SOURCE Dynavax Technologies
FAQ
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