Dynavax Reports Third Quarter 2024 Financial Results and Provides Business Updates
DVAX 11.07.2024
Drug:HEPLISAV-B HEPLISAV-B
Diseases:Hepatitis B
Date of Upcoming Event:2024-11-07
Name of Upcoming Event:Conference Call
- 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
"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
"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
- 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 theU.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
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 theU.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-1018is an investigational vaccinecandidatebeing 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:
- 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 theDoD 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 theU.S. Department of Defense .
Cost of Sales - Product.Cost of sales - product for HEPLISAV-B in the third quarter of 2024 decreased to
Research and Development Expenses (R&D).R&D expenses for the third quarter of 2024 increased to
Selling, General, and Administrative Expenses (SG&A).SG&A expenses for the third quarter of 2024 increased to
Net Income.Net income was
Full Year 2024 FINANCIAL GUIDANCE
- 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
To dial into the call, participants will need to register for the call using theparticipant 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
Forward-Looking StatementsThis 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
For Investors/Media:
DYNAVAX TECHNOLOGIES CORPORATION | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
(In thousands, except per share amounts) | |||||||
(Unaudited) | |||||||
Three Months Ended | Nine Months Ended | ||||||
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) | |||
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 | |
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