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Dynavax Reports Third Quarter 2024 Financial Results and Provides Business Updates

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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 (DVAX) ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con HEPLISAV-B che ha raggiunto un fatturato netto trimestrale record di 79,3 milioni di dollari, in aumento del 27% rispetto all'anno precedente. I ricavi totali dell'azienda hanno raggiunto 80,6 milioni di dollari, con un incremento del 16% rispetto al terzo trimestre del 2023. La quota di mercato di HEPLISAV-B negli Stati Uniti è cresciuta al 44%, con performance particolarmente forti nei segmenti delle farmacie al dettaglio (55%) e degli IDN (56%). L'azienda prevede che il mercato del vaccino per l'epatite B per adulti supererà i 900 milioni di dollari entro il 2030, con HEPLISAV-B che punta ad almeno il 60% di quota di mercato. Dynavax ha riportato un utile netto di 17,6 milioni di dollari e mantiene una solida posizione di cassa di 764 milioni di dollari. L'azienda ha anche annunciato un programma di riacquisto di azioni del valore di 200 milioni di dollari e ha interrotto il suo programma di sviluppo del Tdap-1018.

Dynavax (DVAX) informó sobre resultados financieros sólidos para el tercer trimestre de 2024, con HEPLISAV-B alcanzando un ingreso neto de producto trimestral récord de 79.3 millones de dólares, un aumento del 27% en comparación con el año anterior. Los ingresos totales de la compañía alcanzaron los 80.6 millones de dólares, un incremento del 16% respecto al tercer trimestre de 2023. La cuota de mercado de HEPLISAV-B en EE. UU. creció al 44%, con un desempeño particularmente fuerte en las farmacias minoristas (55%) y en el segmento IDN (56%). La empresa espera que el mercado de la vacuna para adultos contra la hepatitis B alcance más de 900 millones de dólares para 2030, con HEPLISAV-B apuntando a al menos el 60% de cuota de mercado. Dynavax reportó un ingreso neto de 17.6 millones de dólares y mantiene una sólida posición de efectivo de 764 millones de dólares. La compañía también anunció un programa de recompra de acciones de 200 millones de dólares y suspendió su programa de desarrollo del Tdap-1018.

다이나벡스 (DVAX)는 2024년 3분기 강력한 재무 결과를 보고했으며, HEPLISAV-B는 분기 순 제품 수익 7930만 달러를 기록하여 지난해 같은 기간보다 27% 증가했습니다. 회사의 총 수익은 8060만 달러에 달했으며, 이는 2023년 3분기 대비 16% 증가한 수치입니다. HEPLISAV-B의 미국 시장 점유율은 44%로 성장했으며, 특히 소매 약국(55%) 및 IDN 부문(56%)에서 강력한 성과를 보였습니다. 회사는 2030년까지 성인용 B형 간염 백신 시장이 9억 달러를 초과할 것으로 예상하며, HEPLISAV-B는 최소 60%의 시장 점유율을 목표로 하고 있습니다. 다이나벡스는 1760만 달러의 순이익을 보고했으며, 7억 6400만 달러의 강력한 현금 보유를 유지하고 있습니다. 또한 2억 달러 규모의 자사주 매입 프로그램을 발표했으며, Tdap-1018 개발 프로그램을 중단했습니다.

Dynavax (DVAX) a annoncé des résultats financiers solides pour le troisième trimestre 2024, avec HEPLISAV-B atteignant un chiffre d'affaires net trimestriel record de 79,3 millions de dollars, soit une augmentation de 27 % par rapport à l'année précédente. Les revenus totaux de l'entreprise ont atteint 80,6 millions de dollars, en hausse de 16 % par rapport au troisième trimestre 2023. La part de marché de HEPLISAV-B aux États-Unis a augmenté à 44 %, avec des performances particulièrement fortes dans le secteur des pharmacies de détail (55 %) et dans les segments IDN (56 %). L'entreprise s'attend à ce que le marché du vaccin contre l'hépatite B pour adultes dépasse 900 millions de dollars d'ici 2030, HEPLISAV-B visant au moins 60 % de part de marché. Dynavax a déclaré un bénéfice net de 17,6 millions de dollars et maintient une solide position de liquidités de 764 millions de dollars. L'entreprise a également annoncé un programme de rachat d'actions de 200 millions de dollars et a interrompu son programme de développement Tdap-1018.

Dynavax (DVAX) berichtete über starke Finanzresultate im dritten Quartal 2024, wobei HEPLISAV-B einen Rekordumsatz von 79,3 Millionen Dollar erzielte, was einem Anstieg von 27 % im Vergleich zum Vorjahr entspricht. Der Gesamterlös des Unternehmens belief sich auf 80,6 Millionen Dollar, ein Anstieg von 16 % im Vergleich zum dritten Quartal 2023. Der Marktanteil von HEPLISAV-B in den USA wuchs auf 44 %, insbesondere stark in den Einzelhandelsapotheken (55 %) und IDN-Segmenten (56 %). Das Unternehmen erwartet, dass der Markt für den Hepatitis-B-Impfstoff für Erwachsene bis 2030 über 900 Millionen Dollar erreichen wird, wobei HEPLISAV-B mindestens 60 % Marktanteil anstrebt. Dynavax meldete einen Nettogewinn von 17,6 Millionen Dollar und hält eine starke Barreserve von 764 Millionen Dollar. Das Unternehmen kündigte außerdem ein Programm zur Aktienrückkäufe im Wert von 200 Millionen Dollar an und stellte sein Entwicklungsprogramm für Tdap-1018 ein.

Positive
  • Record HEPLISAV-B quarterly revenue of $79.3M, up 27% YoY
  • Market share increased to 44% from 41% YoY
  • Strong cash position of $764M, up from $742.3M in December 2023
  • Net income of $17.6M ($0.13 per share)
  • Announced $200M share repurchase program
  • Expected positive net income for full year 2024
Negative
  • Other revenue decreased 82% to $1.3M from $7.2M YoY
  • SG&A expenses increased to $43.1M from $38.1M YoY
  • Discontinued Tdap-1018 vaccine program due to insufficient differentiation
  • Narrowed down HEPLISAV-B revenue guidance to $265-270M from $265-280M

Insights

Q3 results demonstrate strong commercial execution with $79.3M in HEPLISAV-B revenue, up 27% YoY. The company's financial position is robust with $764M cash on hand. Key positives include:

  • Market share gains to 44% overall and 55% in retail pharmacy segment
  • Healthy gross margins around 80%
  • Projected market expansion to $900M by 2030 with expected 60% market share
  • New $200M share buyback program signals confidence

While R&D costs increased slightly, the discontinuation of Tdap-1018 program shows disciplined capital allocation. The narrowed revenue guidance of $265-270M for 2024 and projected profitability indicate strong operational execution.

The FDA label update including pregnancy safety data strengthens HEPLISAV-B's market position. The vaccine continues to differentiate itself with a two-dose regimen versus competitors' three-dose schedules. The pipeline shows strategic focus with:

  • Advancement of Z-1018 shingles vaccine program with data expected H2 2025
  • Ongoing plague vaccine development with DoD funding
  • Rational discontinuation of Tdap-1018 based on insufficient differentiation

The company's focus on high-value opportunities while terminating less promising programs demonstrates sound development strategy. The expanding hepatitis B vaccine market and strong positioning should drive sustained growth.

  • HEPLISAV-B® quarterly net product revenue of $79.3 million, representing 27% year-over-year growth
  • Hepatitis B adult vaccine market expected to expand to a peak of over $900 million by 2030, with HEPLISAV-B expected to achieve at least 60% estimated total market share
  • Expect positive net income in 2024, achieving full year profitability
  • Strengthened cash position to $764 million in Q3'24 
  • $200 million share repurchase program announced as part of balanced capital allocation strategy
  • Conference call today at 4:30 p.m. ET/1:30 p.m. PT

EMERYVILLE, Calif., Nov. 7, 2024 /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 September 30, 2024.

"We are confident that the continued top-line growth of HEPLISAV-B sets the foundation for durable, long-term value creation. We believe our commercial execution to date, overall financial position, and our commitment to achieving profitability, afford us the capacity to return cash to shareholders through the share repurchase program announced today. We will continue to execute on our strategic growth pillars focused on maximizing the HEPLISAV-B opportunity, delivering on our clinical pipeline, and pursuing external opportunities to drive sustainable value for our shareholders," said Ryan Spencer, Chief Executive Officer of Dynavax.

"Additionally, we have decided to discontinue development of our Tdap-1018 program based on results from the Phase 1 extension study. The program showed improved immunogenicity driven by CpG 1018, however, we do not believe the data support sufficient differentiation to be successful commercially. This decision aligns with our commitment to prudent management of resources aimed at generating long-term value."

BUSINESS UPDATES

HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and Great Britain that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.

  • HEPLISAV-B achieved record quarterly net product revenue of $79.3 million for the third quarter of 2024, an increase of 27% compared to $62.3 million for the third quarter of 2023.
  • HEPLISAV-B total estimated market share in the U.S. increased to approximately 44%, compared to approximately 41% for the third quarter 2023.
  • HEPLISAV-B estimated market share in the retail pharmacy segment increased to approximately 55%, compared to approximately 53% for the third quarter of 2023. HEPLISAV-B estimated market share in the Integrated Delivery Networks (IDNs) and Large Clinics segment was approximately 56%, compared to approximately 54% for the third quarter of 2023.
  • Dynavax now expects the hepatitis B adult vaccine market in the U.S. to expand to a peak of over $900 million in annual sales by 2030, with HEPLISAV-B expected to achieve at least 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.

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 Regulatory Updates

  • In the third quarter, the U.S. Food and Drug Administration (FDA) approved the Company's supplemental Biologics License Application (sBLA) to include pregnancy information from HBV-28, a post-licensure observational retrospective cohort study, in the U.S. label for HEPLISAV-B. The HBV-28 study showed no increased risk of major birth defects or miscarriage in women who received HEPLISAV-B compared to an active comparator.
  • Regarding the Complete Response Letter issued for the sBLA to include a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis on the U.S. label, Dynavax recently received feedback from the FDA regarding the potential to conduct an observational retrospective cohort study to support the sBLA filing.

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 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.

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 U.S. Department of Defense (DoD).

  • Based on the results from a randomized, active-controlled Phase 2 clinical trial of the two-dose plague vaccine adjuvanted with CpG 1018, Dynavax has submitted a proposal to the DoD regarding additional clinical and manufacturing activities. 

Tdap vaccine program:
Tdap-1018 was an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis (Tdap).

  • Dynavax announced today that it has decided to discontinue development of its Tdap-1018 program based on results from a long-term Phase 1 extension study that did not demonstrate a differentiated profile that the Company believes would be successful commercially.

THIRD QUARTER 2024 FINANCIAL HIGHLIGHTS

Total Revenues and Net Product Revenue.

  • Total revenues for the third quarter of 2024 were $80.6 million, a 16% year-over-year increase compared to $69.5 million for the third quarter of 2023.
  • HEPLISAV-B net product revenue was $79.3 million for the third quarter of 2024, a 27% year-over-year increase compared to $62.3 million for the third quarter of 2023.
  • Other revenue was $1.3 million for the third quarter of 2024, an 82% decrease compared to $7.2 million for the third quarter of 2023. Other revenue primarily includes revenue from the plague vaccine agreement with the U.S. Department of Defense.

Cost of Sales - Product. Cost of sales - product for HEPLISAV-B in the third quarter of 2024 decreased to $13.1 million, compared to $13.2 million for the third quarter of 2023. The decrease was primarily due to lower per-unit manufacturing costs as a result of previous process improvements, partially offset by higher sales volumes.

Research and Development Expenses (R&D). R&D expenses for the third quarter of 2024 increased to $14.4 million, compared to $14.1 million for the third quarter of 2023. The increase was primarily driven by costs related to the ongoing Phase 1/2 clinical trial for the shingles program, partially offset by the completion of clinical trial activities for the Tdap and plague programs.

Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the third quarter of 2024 increased to $43.1 million, compared to $38.1 million for the third quarter of 2023. The increase was primarily driven by increased headcount and other investments to support HEPLISAV-B and pipeline growth.

Net Income. Net income was $17.6 million, or $0.13 per share basic and $0.12 diluted in the third quarter of 2024, compared to net income of $14.3 million, or $0.11 per share basic and $0.10 diluted in the third quarter of 2023.

Cash and Marketable Securities. Cash, cash equivalents and marketable securities were $764.0 million as of September 30, 2024, an increase compared to $742.3 million as of December 31, 2023.

Full Year 2024 FINANCIAL GUIDANCE

Dynavax is updating its full year 2024 financial guidance, based on the Company's current operating plan: 

  • Narrowing HEPLISAV-B net product revenue range from approximately $265 to $280 million, to approximately $265 to $270 million
  • Reiterating HEPLISAV-B gross margin of approximately 80%
  • Reducing and narrowing research and development expense range from approximately $60 to $75 million, to approximately $55 to $65 million
  • Narrowing selling, general and administrative expense range from approximately $160 to $180 million, to approximately $170 to $180 million
  • Expect positive net income for full year 2024

Conference Call and Webcast Information

Dynavax will host a conference call and live audio webcast on Thursday, November 7, 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 participant call link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

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 U.S., the European Union and Great Britain 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 our marketed products and development pipeline, visit www.dynavax.com.

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, 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 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 U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

For Investors/Media:
Paul Cox
pcox@dynavax.com
510-665-0499

Nicole Arndt
narndt@dynavax.com
510-665-7264

 

DYNAVAX TECHNOLOGIES CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)



Three Months Ended


Nine Months Ended


September 30,


September 30,


2024


2023


2024


2023

Revenues:








Product revenue, net

$                79,345


$                62,318


$              197,377


$              162,209

Other revenue

1,285


7,196


7,837


14,479

Total revenues

80,630


69,514


205,214


176,688









Operating expenses:








Cost of sales - product

13,084


13,229


36,035


41,478

Research and development

14,403


14,116


42,881


40,767

Selling, general and administrative

43,061


38,053


128,788


111,667

Gain on sale of assets

-


(1,000)




(1,000)

Bad debt expense

-


-


-


12,313

Total operating expenses

70,548


64,398


207,704


205,225









Income (loss) from operations

10,082


5,116


(2,490)


(28,537)









Other income (expense):








Interest income

9,382


8,462


28,050


22,437

Interest expense

(1,699)


(1,691)


(5,090)


(5,065)

Sublease income

2,205


1,993


2,808


5,584

Other

(152)


266


(52)


218

Net income (loss) before income taxes

19,818


14,146


23,226


(5,363)

(Provision for) benefit from income taxes

(2,224)


147


(2,967)


(1,245)

Net income (loss)

$                17,594


$                14,293


$                20,259


$               (6,608)









Net income (loss) per share attributable to common stockholders
















Basic

$                     0.13


$                     0.11


$                     0.15


$                   (0.05)

Diluted

$                     0.12


$                     0.10


$                     0.15


$                   (0.05)









Weighted-average shares used in computing net income (loss) per share attributable to common stockholders:
















Basic

131,133


128,988


130,746


128,515

Diluted

154,807


154,196


133,644


128,515

 

DYNAVAX TECHNOLOGIES CORPORATION

SELECTED BALANCE SHEET DATA

(In thousands)

(Unaudited)



September 30,
2024


December 31,
2023

Assets




Cash, cash equivalents and marketable securities

$               763,992


$               742,302

Inventories

62,402


53,290

Other current assets

99,847


63,528

Total current assets

926,241


859,120

Total non-current assets

135,749


137,976

Total assets

$           1,061,990


$               997,096





Liabilities and stockholders' equity




Total current liabilities

70,030


62,195

Total long-term liabilities

310,533


312,829

Stockholders' equity

681,427


622,072

Total liabilities and stockholders' equity

$           1,061,990


$               997,096

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-reports-third-quarter-2024-financial-results-and-provides-business-updates-302298486.html

SOURCE Dynavax Technologies

FAQ

What was Dynavax's (DVAX) HEPLISAV-B revenue in Q3 2024?

HEPLISAV-B net product revenue was $79.3 million in Q3 2024, representing a 27% increase from $62.3 million in Q3 2023.

What is DVAX's current market share for HEPLISAV-B?

HEPLISAV-B's total estimated market share in the U.S. reached 44% in Q3 2024, with approximately 55% share in retail pharmacy and 56% in IDN segments.

What is Dynavax's (DVAX) cash position as of Q3 2024?

Dynavax reported cash, cash equivalents and marketable securities of $764.0 million as of September 30, 2024.

What is DVAX's projected market size for HEPLISAV-B by 2030?

Dynavax expects the hepatitis B adult vaccine market to expand to over $900 million in annual sales by 2030, with HEPLISAV-B targeting at least 60% market share.

Dynavax Technologies Corporation

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