Dynavax Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Full Year 2025 Financial Guidance
Rhea-AI Summary
Dynavax Technologies (DVAX) reported strong financial results for Q4 and full year 2024, with HEPLISAV-B net product revenue growing 26% year-over-year to $268.4 million. The company's Q4 revenue reached $71.1 million, up 39% from the previous year.
Key highlights include:
- HEPLISAV-B U.S. market share increased to 44% by end of 2024
- Full year 2024 GAAP net income of $27.3 million ($0.21 per share)
- Cash position of $713.8 million as of December 31, 2024
- Adjusted EBITDA of $51.9 million for 2024, up 329% year-over-year
For 2025, Dynavax expects HEPLISAV-B net product revenue between $305-325 million and adjusted EBITDA of at least $75 million. The company plans to complete its $200 million share repurchase program and anticipates top-line results from its Phase 1/2 shingles vaccine trial in Q3 2025.
Positive
- HEPLISAV-B revenue grew 26% YoY to $268.4M in 2024
- Q4 2024 revenue increased 39% YoY to $71.1M
- Market share in U.S. increased to 44%
- Turned profitable with $27.3M net income in 2024 vs $6.4M loss in 2023
- Strong cash position of $713.8M
- 329% increase in adjusted EBITDA to $51.9M
- $200M share repurchase program underway
Negative
- Operating expenses increased with R&D up to $61.6M from $54.9M
- SG&A expenses rose to $170.4M from $152.9M
News Market Reaction 1 Alert
On the day this news was published, DVAX declined NaN%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- HEPLISAV-B® 2024 net product revenue grew
26% year-over-year to$268 million $305 $325 million - Top-line results in Phase 1/2 shingles trial expected in Q3 2025
- Plan to initiate Phase 2 trial for plague vaccine in Q3 2025
- Expect completion of
$200 million - Conference call today at 4:30 p.m. ET/1:30 p.m. PT
"In 2024, we successfully executed on our strategic growth initiatives, achieving record HEPLISAV-B product revenue, advancing our pipeline programs, and maintaining a disciplined approach to capital allocation," said Ryan Spencer, Chief Executive Officer of Dynavax. "Looking ahead to 2025, we plan to drive significant top-line growth as we continue to establish HEPLISAV-B as the market share leader in the expanding hepatitis B vaccine market in the
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 net product revenue of
$268.4 million 26% compared to$213.3 million - HEPLISAV-B achieved quarterly net product revenue of
$71.1 million 39% compared to$51.1 million - HEPLISAV-B total estimated market share in the
U.S. increased to approximately44% at the end of 2024, compared to approximately42% at the end of 2023. - 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.
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.
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
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.
FOURTH QUARTER 2024 FINANCIAL HIGHLIGHTS
- Total revenues were
$72.0 million 30% increase compared to$55.6 million - HEPLISAV-B net product revenue was
$71.1 million 39% increase compared to$51.1 million - Cost of sales - product for HEPLISAV-B were
$13.4 million $8.7 million - Research and development expenses (R&D) were
$18.7 million $14.1 million - Selling, general, and administrative expenses (SG&A) were
$41.6 million $41.3 million - GAAP net income was
$7.1 million $0.06 $0.05 $0.2 million $0.00 - Adjusted EBITDA* (excluding stock-based compensation) was
$13.4 million $4.1 million 225% increase year-over-year. - Cash, cash equivalents and marketable securities were
$713.8 million $742.3 million - Share Repurchase Program: In November 2024, Dynavax announced a
$200 million $100 million $200 million
FULL YEAR 2024 FINANCIAL HIGHLIGHTS
- Total revenues were
$277.2 million 19% increase compared to$232.3 million - HEPLISAV-B net product revenue was
$268.4 million 26% increase compared to$213.3 million - Cost of sales - product for HEPLISAV-B were
$49.4 million $50.2 million - Research and development expenses (R&D) were
$61.6 million $54.9 million - Selling, general, and administrative expenses (SG&A) were
$170.4 million $152.9 million - GAAP net income was
$27.3 million $0.21 $0.20 $6.4 million $0.05 - Adjusted EBITDA* (excluding stock-based compensation) was
$51.9 million $12.1 million 329% increase year-over-year.
FULL YEAR 2025 FINANCIAL GUIDANCE
Dynavax is providing its full year 2025 financial guidance, based on the Company's current operating plan:
- HEPLISAV-B net product revenue is expected in the range of
$305 $325 million - Adjusted EBITDA* (excluding stock-based compensation) is expected to be at least
$75 million
* Non-GAAP financial measure. Please refer to the "Non-GAAP Financial Measures" section for details regarding this measure.
Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on Thursday, February 20, 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 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
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 (
There are no adequate and well-controlled studies of HEPLISAV-B in pregnant individuals. Available data, primarily in individuals who received one dose of HEPLISAV-B in the 28 days prior to or during pregnancy, do not suggest an increased risk of major birth defects and miscarriage.
It is not known whether HEPLISAV-B is excreted in human milk.
Data are not available to assess the effects of HEPLISAV-B on the breastfed infant or on milk production/excretion.
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
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
Non-GAAP Financial Measures
To supplement our financial results presented on a GAAP basis, we have included information about adjusted EBITDA, a non-GAAP financial measure. We believe the presentation of this non-GAAP financial measure, when viewed with our results under GAAP and the accompanying reconciliation, provide analysts, investors and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting.
In our quarterly and annual reports, earnings press releases and conference calls, we may discuss adjusted EBITDA to supplement our consolidated financial statements presented on a GAAP basis.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.
There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as:
- adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;
- adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;
- adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes;
- adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments;
- we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position;
- we may exclude other expenses, from time to time, that are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis.
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 Annual Report on Form 10-K for the year ended December 31, 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
DYNAVAX TECHNOLOGIES CORPORATION | |||||||
Three Months Ended | Year Ended | ||||||
December 31, | December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Revenues: | |||||||
Product revenue, net | $ 71,053 | $ 51,086 | $ 268,430 | $ 213,295 | |||
Other revenue | 979 | 4,510 | 8,816 | 18,989 | |||
Total revenues | 72,032 | 55,596 | 277,246 | 232,284 | |||
Operating expenses: | |||||||
Cost of sales - product | 13,410 | 8,689 | 49,445 | 50,167 | |||
Research and development | 18,669 | 14,119 | 61,550 | 54,886 | |||
Selling, general and administrative | 41,585 | 41,279 | 170,373 | 152,946 | |||
Gain on sale of assets | - | - | - | (1,000) | |||
Bad debt expense | - | - | - | 12,313 | |||
Total operating expenses | 73,664 | 64,087 | 281,368 | 269,312 | |||
Loss from operations | (1,632) | (8,491) | (4,122) | (37,028) | |||
Other income (expense): | |||||||
Interest income | 8,414 | 9,556 | 36,464 | 31,993 | |||
Interest expense | (1,704) | (1,692) | (6,794) | (6,757) | |||
Sublease income | 2,206 | 1,993 | 5,014 | 7,577 | |||
Other | 345 | (370) | 293 | (152) | |||
Net income (loss) before income taxes | 7,629 | 996 | 30,855 | (4,367) | |||
Provision for income taxes | (579) | (777) | (3,546) | (2,022) | |||
Net income (loss) | 7,050 | 219 | 27,309 | (6,389) | |||
Net income (loss) per share attributable | |||||||
Basic | $ 0.06 | $ 0.00 | $ 0.21 | $ (0.05) | |||
Diluted | $ 0.05 | $ 0.00 | $ 0.20 | $ (0.05) | |||
Weighted-average shares used in | |||||||
Basic | 127,952 | 129,381 | 130,047 | 128,733 | |||
Diluted | 153,022 | 133,278 | 133,344 | 128,733 | |||
DYNAVAX TECHNOLOGIES CORPORATION | |||
December 31, | December 31, | ||
Assets | |||
Cash, cash equivalents and marketable securities | $ 713,834 | $ 742,302 | |
Inventories | 70,054 | 53,290 | |
Other current assets | 65,053 | 63,528 | |
Total current assets | 848,941 | 859,120 | |
Total non-current assets | 137,315 | 137,976 | |
Total assets | $ 986,256 | $ 997,096 | |
Liabilities and stockholders' equity | |||
Total current liabilities | $ 78,634 | $ 62,195 | |
Total long-term liabilities | 310,823 | 312,829 | |
Stockholders' equity | 596,799 | 622,072 | |
Total liabilities and stockholders' equity | $ 986,256 | $ 997,096 | |
DYNAVAX TECHNOLOGIES CORPORATION | |||||||
Three Months Ended | Year Ended | ||||||
December 31, | December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP Net income (loss) | $ 7,050 | $ 219 | $ 27,309 | $ (6,389) | |||
Adjustments: | |||||||
Depreciation & Amortization | 374 | 375 | 1,499 | 1,500 | |||
Interest Income | (8,414) | (9,556) | (36,464) | (31,993) | |||
Interest Expense | 1,704 | 1,692 | 6,794 | 6,757 | |||
Provision for Income Taxes | 579 | 777 | 3,546 | 2,022 | |||
Total adjustments | (5,757) | (6,712) | (24,625) | (21,714) | |||
EBITDA | 1,293 | (6,493) | 2,684 | (28,103) | |||
Stock-Based Compensation | 12,153 | 10,624 | 49,217 | 40,192 | |||
Adjusted EBITDA | $ 13,446 | $ 4,131 | $ 51,901 | $ 12,089 | |||
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SOURCE Dynavax Technologies
FAQ
What is DVAX's revenue guidance for HEPLISAV-B in 2025?
How much did DVAX's HEPLISAV-B revenue grow in 2024?
What is DVAX's current market share for HEPLISAV-B in the US?
When will DVAX report Phase 1/2 shingles vaccine trial results?
How much is DVAX's share repurchase program worth?
