Dynavax Reports Second Quarter 2024 Financial Results and Provides Business Updates
Dynavax Technologies (Nasdaq: DVAX) reported strong Q2 2024 financial results, highlighting record HEPLISAV-B net product revenue of $70.2 million, a 24% year-over-year increase. The company reaffirmed its full-year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million. Dynavax's total estimated market share in the U.S. increased to approximately 42%, with significant growth in retail pharmacy and IDN segments.
The company initiated dosing in a Phase 1/2 trial for its novel shingles vaccine program, with clinical data expected in 2H 2025. Dynavax also provided updates on its Tdap and plague vaccine programs. Financially, the company reported total revenues of $73.8 million, a 22% year-over-year increase, and net income of $11.4 million or $0.09 per share basic. Cash and marketable securities stood at $735.6 million as of June 30, 2024.
Dynavax Technologies (Nasdaq: DVAX) ha riportato forti risultati finanziari nel secondo trimestre del 2024, evidenziando un record di entrate nette da prodotto HEPLISAV-B di 70,2 milioni di dollari, un incremento del 24% rispetto all'anno precedente. L'azienda ha confermato la previsione di entrate nette per l'anno intero 2024 per HEPLISAV-B, stimata tra 265 e 280 milioni di dollari. La quota di mercato totale stimata di Dynavax negli Stati Uniti è aumentata a circa il 42%, con una crescita significativa nei segmenti delle farmacie al dettaglio e degli IDN.
L'azienda ha avviato la somministrazione in uno studio clinico di Fase 1/2 per il suo nuovo programma di vaccini contro il fuoco di Sant'Antonio, con dati clinici attesi nella seconda metà del 2025. Dynavax ha anche fornito aggiornamenti sui suoi programmi di vaccini Tdap e contro la peste. A livello finanziario, l'azienda ha riportato entrate totali di 73,8 milioni di dollari, un incremento del 22% rispetto all'anno precedente, e un utile netto di 11,4 milioni di dollari, pari a 0,09 dollari per azione. Le disponibilità liquide e i titoli commerciabili ammontavano a 735,6 milioni di dollari al 30 giugno 2024.
Dynavax Technologies (Nasdaq: DVAX) reportó sólidos resultados financieros en el segundo trimestre de 2024, destacando un récord de ingresos netos por producto de HEPLISAV-B de 70,2 millones de dólares, un aumento del 24% en comparación con el año anterior. La empresa reafirmó su guía de ingresos netos por producto de HEPLISAV-B para el año completo de 2024, estimada entre 265 y 280 millones de dólares. La participación de mercado total estimada de Dynavax en EE. UU. aumentó aproximadamente al 42%, con un crecimiento significativo en los segmentos de farmacias minoristas y IDN.
La empresa inició la dosificación en un ensayo de Fase 1/2 para su nuevo programa de vacunas contra el herpes zóster, con datos clínicos esperados en la segunda mitad de 2025. Dynavax también proporcionó actualizaciones sobre sus programas de vacunas Tdap y contra la peste. Financieraente, la empresa reportó ingresos totales de 73,8 millones de dólares, un aumento del 22% en comparación con el año anterior, y una ganancia neta de 11,4 millones de dólares, o 0,09 dólares por acción básica. El efectivo y los valores negociables se situaron en 735,6 millones de dólares al 30 de junio de 2024.
다이나백스 테크놀로지스 (Nasdaq: DVAX)는 2024년 2분기 강력한 재무 결과를 보고하며 HEPLISAV-B의 순제품 수익이 7020만 달러로 연간 24% 증가했다고 강조했습니다. 회사는 2024년 전체 HEPLISAV-B 순제품 수익에 대한 가이던스를 2억 6500만 달러에서 2억 8000만 달러로 재확인했습니다. 다이나백스의 미국 내 총 추정 시장 점유율은 약 42%로 증가했으며, 소매 약국 및 IDN 부문에서 큰 성장이 있었습니다.
회사는 신종 대상포진 백신 프로그램에 대해 1/2상 시험에서 투약을 시작했으며, 임상 데이터는 2025년 하반기에 예상됩니다. 다이나백스는 또한 Tdap 및 페스트 백신 프로그램에 대한 업데이트를 제공했습니다. 재무적으로, 회사는 총 수익이 7380만 달러로 연간 22% 증가했으며, 순이익은 1140만 달러 또는 주당 0.09 달러였습니다. 현금 및 유가증권은 2024년 6월 30일 기준으로 7억 3560만 달러에 달했습니다.
Dynavax Technologies (Nasdaq: DVAX) a annoncé de solides résultats financiers pour le deuxième trimestre de 2024, mettant en avant un chiffre record de revenus nets de produit HEPLISAV-B de 70,2 millions de dollars, soit une augmentation de 24 % par rapport à l'année précédente. L'entreprise a confirmé son objectif de revenus nets pour l'année entière 2024 pour HEPLISAV-B, estimé entre 265 et 280 millions de dollars. La part de marché totale estimée de Dynavax aux États-Unis a atteint environ 42 %, avec une croissance significative dans les segments de la pharmacie de détail et des IDN.
L'entreprise a initié l'administration d'un essai de Phase 1/2 pour son nouveau programme de vaccin contre le zona, avec des données cliniques attendues dans la seconde moitié de 2025. Dynavax a également fourni des mises à jour sur ses programmes de vaccins Tdap et contre la peste. D'un point de vue financier, l'entreprise a rapporté des revenus totaux de 73,8 millions de dollars, soit une augmentation de 22 % par rapport à l'année précédente, et un bénéfice net de 11,4 millions de dollars, ou 0,09 dollar par action ordinaire. La trésorerie et les titres négociables se chiffraient à 735,6 millions de dollars au 30 juin 2024.
Dynavax Technologies (Nasdaq: DVAX) hat starke Finanzresultate für das zweite Quartal 2024 berichtet und hebt einen Rekord von netto Einnahmen aus dem Produkt HEPLISAV-B in Höhe von 70,2 Millionen Dollar hervor, was einem Anstieg von 24% im Vergleich zum Vorjahr entspricht. Das Unternehmen bekräftigte seine Prognose für die netto Einnahmen von HEPLISAV-B für das gesamte Jahr 2024 zwischen 265 und 280 Millionen Dollar. Der geschätzte Gesamtmarktanteil von Dynavax in den USA stieg auf etwa 42%, mit erheblichem Wachstum im Bereich der Einzelhandelsapotheken und IDN-Segmente.
Das Unternehmen begann mit der Dosierung in einer Phase 1/2-Studie für sein neuartiges Impfstoffprogramm gegen Gürtelrose, wobei klinische Daten im zweiten Halbjahr 2025 erwartet werden. Dynavax gab auch Updates zu seinen Tdap- und Pestimpfprogrammen bekannt. Finanzielle berichtete das Unternehmen von Gesamterlösen von 73,8 Millionen Dollar, was einem Anstieg von 22% im Vergleich zum Vorjahr entspricht, und einem Nettogewinn von 11,4 Millionen Dollar oder 0,09 Dollar pro Stammaktie. Die liquiden Mittel und marktgängigen Wertpapiere beliefen sich zum 30. Juni 2024 auf 735,6 Millionen Dollar.
- Record HEPLISAV-B net product revenue of $70.2 million, up 24% year-over-year
- Total estimated market share in the U.S. increased to 42%
- Retail pharmacy segment market share increased to 59%
- IDNs and Large Clinics segment market share increased to 56%
- Total revenues increased 22% year-over-year to $73.8 million
- Net income of $11.4 million, up from $3.4 million in Q2 2023
- Strong cash position of $735.6 million as of June 30, 2024
- Initiated Phase 1/2 trial for novel shingles vaccine program
- FDA issued a Complete Response Letter for the HEPLISAV-B sBLA for adults on hemodialysis
- Slight decrease in other revenue by 5% to $3.6 million
- Increased R&D expenses to $15.0 million from $13.0 million in Q2 2023
- Increased SG&A expenses to $41.7 million from $37.1 million in Q2 2023
Insights
Dynavax's Q2 2024 results show strong performance, with HEPLISAV-B achieving record quarterly net product revenue of
The company's strong cash position of
The initiation of the Phase 1/2 trial for Dynavax's novel shingles vaccine program is a significant milestone. With data expected in 2H 2025, this could potentially diversify the company's pipeline beyond hepatitis B. The ongoing development of the Tdap and plague vaccine programs, with updates expected in Q4 2024, further strengthens the company's vaccine portfolio.
However, the FDA's Complete Response Letter for the HEPLISAV-B four-dose regimen for hemodialysis patients is a setback. The company's plan to meet with the FDA in 2H 2024 to discuss pathways forward will be important for expanding HEPLISAV-B's market reach.
Dynavax's projection of the HEPLISAV-B market opportunity expanding to over
The focus on penetrating the unvaccinated adult cohort suggests a long-term growth strategy beyond 2030. However, investors should monitor competitive developments in the hepatitis B vaccine market, as they could impact these projections.
- Achieved record quarterly HEPLISAV-B® net product revenue of
$70.2 million 24% year-over-year - Reaffirming full year 2024 HEPLISAV-B net product revenue guidance of
$265 $280 million - Initiated dosing in Phase 1/2 trial of novel shingles vaccine program with clinical data expected in 2H 2025
- Conference call today at 4:30 p.m. ET/1:30 p.m. PT
"We continue to strengthen our leadership position in the
"For our pipeline development, we are pleased to have recently initiated our Phase 1/2 trial for our novel shingles vaccine program, and remain excited for several upcoming milestones, including data readouts from the shingles study as well as our Tdap and plague vaccine programs expected across 2024 and 2025. In addition to this progress, and bolstered by our strong financial position, we continue to evaluate strategic opportunities to accelerate growth, further diversify our portfolio, and deliver value to our shareholders."
BUSINESS UPDATES
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the
- HEPLISAV-B vaccine achieved record quarterly net product revenue of
$70.2 million 24% compared to$56.4 million - HEPLISAV-B total estimated market share in the
U.S. increased to approximately42% , compared to approximately39% for the second quarter 2023. - HEPLISAV-B estimated market share in the retail pharmacy segment increased to approximately
59% , compared to approximately45% for the second quarter of 2023. HEPLISAV-B estimated market share in the Integrated Delivery Networks (IDNs) and Large Clinics segment increased to approximately56% , compared to approximately53% for the second quarter 2023. - Dynavax expects the HEPLISAV-B market opportunity in the
U.S. to expand to over$800 million
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 May 2024, Dynavax announced that the
U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis on theU.S. label. - The Company intends to meet with the FDA in the second half of 2024, as part of the standard post-CRL regulatory process, to discuss pathways to amend its sBLA with additional data to support the four-dose regimen for the adult hemodialysis population in the
U.S.
Shingles vaccine program:
Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 years and older.
- In June 2024, Dynavax announced the initiation of 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 approximately 440 healthy adults aged 50 to 69.
- Dynavax anticipates reporting top line immunogenicity and safety data in the second half of 2025, including a comparison of CD4+ T-cells one month after the second of two vaccine doses.
Tdap vaccine program:
Tdap-1018 is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis (Tdap).
- Dynavax plans to evaluate the persistence of pertussis immunogenicity of Tdap-1018 through a long-term follow-up study of participants that completed a Phase 1 trial of a booster dose of Tdap-1018 compared to an active control. The extension study is expected to follow participants for up to three years following initial vaccination. Results from the Phase 1 extension study are expected in the fourth quarter of 2024.
Plague vaccine program:
Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018® currently in a Phase 2 clinical trial in collaboration with, and fully funded by, the
- Dynavax anticipates providing a program update, based on results from both a randomized, active-controlled Phase 2 clinical trial and a nonhuman primate challenge study of the plague vaccine candidate, in the fourth quarter of 2024.
SECOND QUARTER 2024 FINANCIAL HIGHLIGHTS
Total Revenues and Net Product Revenue.
- Total revenues for the second quarter of 2024 were
$73.8 million 22% year-over-year increase compared to$60.2 million - HEPLISAV-B net product revenue was
$70.2 million 24% year-over-year increase compared to$56.4 million - Other revenue was
$3.6 million 5% decrease compared to$3.8 million U.S. Department of Defense.
Cost of Sales - Product. Cost of sales - product for HEPLISAV-B in the second quarter of 2024 decreased to
Research and Development Expenses (R&D). R&D expenses for the second quarter of 2024 increased to
Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the second quarter of 2024 increased to
Net Income. Net income was
Cash and Marketable Securities. Cash, cash equivalents and marketable securities were
2024 FINANCIAL GUIDANCE
Dynavax is reiterating its full year 2024 financial guidance, based on the Company's current operating plan:
- HEPLISAV-B net product revenue between approximately
$265 $280 million $3 million U.S. sales through commercialization partnership in Germany - HEPLISAV-B gross margin of approximately
80% - Research and development expenses between approximately
$60 $75 million - Selling, general and administrative expenses between approximately
$160 $180 million - Cash, cash equivalents and marketable securities to be higher as of December 31, 2024, compared to December 31, 2023
Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on Tuesday, August 6, 2024, 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 the Company's website at https://investors.dynavax.com/events-presentations. A replay of the webcast will be available for 30 days following the live event.
To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.
Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.
For full
Important
Do not administer HEPLISAV-B to individuals with a history of a 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 (
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 and market share as of and for the year ended December 31, 2024, expectations regarding our future growth, extent and timing of market growth and market share beyond 2024, 2027 and 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 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 June 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
For Investors/Media:
Paul Cox
pcox@dynavax.com
510-665-0499
Nicole Arndt
narndt@dynavax.com
510-665-7264
DYNAVAX TECHNOLOGIES CORPORATION | |||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
Revenues: | |||||||||||||
Product revenue, net | $ | 70,188 | $ | 56,440 | $ | 118,032 | $ | 99,891 | |||||
Other revenue | 3,607 | 3,809 | 6,552 | 7,283 | |||||||||
Total revenues | 73,795 | 60,249 | 124,584 | 107,174 | |||||||||
Operating expenses: | |||||||||||||
Cost of sales – product | 11,985 | 13,537 | 22,952 | 28,249 | |||||||||
Research and development | 14,950 | 13,046 | 28,478 | 26,651 | |||||||||
Selling, general and administrative | 41,662 | 37,071 | 85,727 | 73,614 | |||||||||
Bad debt expense | - | - | - | 12,313 | |||||||||
Total operating expenses | 68,597 | 63,654 | 137,157 | 140,827 | |||||||||
Income (loss) from operations | 5,198 | (3,405) | (12,573) | (33,653) | |||||||||
Other income (expense): | |||||||||||||
Interest income | 9,201 | 7,378 | 18,668 | 13,975 | |||||||||
Interest expense | (1,698) | (1,688) | (3,393) | (3,374) | |||||||||
Sublease income | 2,205 | 1,993 | 603 | 3,591 | |||||||||
Other | - | (71) | 103 | (48) | |||||||||
Net income (loss) before income taxes | 14,906 | 4,207 | 3,408 | (19,509) | |||||||||
Provision for income taxes | (3,520) | (776) | (743) | (1,392) | |||||||||
Net income (loss) | $ | 11,386 | $ | 3,431 | $ | 2,665 | $ | (20,901) | |||||
Net income (loss) per share attributable to | |||||||||||||
stockholders: | |||||||||||||
Basic | $ | 0.09 | $ | 0.03 | $ | 0.02 | $ | (0.16) | |||||
Diluted | $ | 0.08 | $ | 0.03 | $ | 0.02 | $ | (0.16) | |||||
Weighted-average shares used in computing net | |||||||||||||
Basic | 130,916 | 128,625 | 130,551 | 128,275 | |||||||||
Diluted | 154,468 | 152,142 | 133,582 | 128,275 | |||||||||
DYNAVAX TECHNOLOGIES CORPORATION | ||||||
SELECTED BALANCE SHEET DATA | ||||||
(In thousands) | ||||||
(Unaudited) | ||||||
June 30, | December 31, | |||||
2024 | 2023 | |||||
Assets | ||||||
Cash, cash equivalents and marketable securities | $ | 735,612 | $ | 742,302 | ||
Inventories | 62,462 | 53,290 | ||||
Other current assets | 83,938 | 63,528 | ||||
Total current assets | 882,012 | 859,120 | ||||
Total non-current assets | 134,309 | 137,976 | ||||
Total assets | $ | 1,016,321 | $ | 997,096 | ||
Liabilities and stockholders' equity | ||||||
Total current liabilities | $ | 62,192 | $ | 62,195 | ||
Total long-term liabilities | 311,280 | 312,829 | ||||
Stockholders' equity | 642,849 | 622,072 | ||||
Total liabilities and stockholders' equity | $ | 1,016,321 | $ | 997,096 | ||
View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-reports-second-quarter-2024-financial-results-and-provides-business-updates-302215762.html
SOURCE Dynavax Technologies
FAQ
What was Dynavax's HEPLISAV-B net product revenue for Q2 2024?
What is Dynavax's full-year 2024 guidance for HEPLISAV-B net product revenue?
What was Dynavax's (DVAX) total estimated market share for HEPLISAV-B in the U.S. for Q2 2024?
When does Dynavax expect to report clinical data for its shingles vaccine program?
What was Dynavax's (DVAX) net income for Q2 2024?
