Dynavax Reports First Quarter 2025 Financial Results and Announces New Pipeline Programs
- Record HEPLISAV-B Q1 revenue of $65 million, up 36% YoY
- Market share increased to 43% from 41% year-over-year
- Strong cash position of $661.3 million
- Expects U.S. hepatitis B market to expand to $900M+ by 2030
- New $30M DoD funding agreement for plague vaccine program
- Successfully executed 85% of $200M share repurchase program
- GAAP net loss of $96.1 million in Q1 2025
- $11M bad debt expense related to Clover Biopharmaceuticals
- Increased R&D expenses to $19.4M from $13.5M YoY
- Higher SG&A expenses at $47.7M vs $44.1M YoY
Insights
Dynavax reports strong Q1 with 36% HEPLISAV-B growth; maintains solid balance sheet despite refinancing-related GAAP loss.
Dynavax delivered record HEPLISAV-B Q1 revenue of $65 million, representing impressive 36% year-over-year growth from $47.8 million. The company's flagship hepatitis B vaccine continues gaining traction, with U.S. market share increasing to 43% from 41% last year. This strong performance positions Dynavax to achieve the upper end of their full-year guidance range of $305-325 million for HEPLISAV-B.
Despite revenue growth, Dynavax reported a GAAP net loss of $96.1 million ($0.77 per share), substantially larger than the $8.7 million loss ($0.07 per share) in Q1 2024. However, this was primarily due to a one-time loss on extinguishment of debt from their March 2025 convertible debt refinancing. The operational picture looks better, with adjusted EBITDA improving to negative $4.4 million from negative $6.8 million in the prior year.
The company's cash position remains robust at $661.3 million, down from $713.8 million at year-end 2024, partly reflecting the aggressive share repurchase program. Dynavax has already completed $172 million of its $200 million share repurchase program announced in November 2024.
A concerning development was the $11 million bad debt expense related to Clover Biopharmaceuticals, reflecting heightened credit risk after Gavi terminated its agreement with Clover and Clover's reported liquidity challenges.
Operating expenses increased with R&D at $19.4 million (up from $13.5 million) and SG&A at $47.7 million (up from $44.1 million), reflecting investments in pipeline expansion and commercial growth. Management maintains a long-term bullish view on HEPLISAV-B, projecting the U.S. hepatitis B adult vaccine market to expand to over $900 million by 2030, with HEPLISAV-B expected to capture at least 60% market share.
Dynavax expands vaccine pipeline with new influenza and Lyme programs while advancing shingles vaccine to key data readout in Q3.
Dynavax is strategically expanding its vaccine portfolio, leveraging its proprietary CpG 1018 adjuvant technology across multiple disease targets. The company's shingles vaccine program (Z-1018) has completed enrollment in Part 1 of a Phase 1/2 trial comparing it to Shingrix, with top-line results expected in Q3 2025. This represents a critical milestone as the company hopes to demonstrate competitive efficacy and tolerability profiles.
The company is diversifying its pipeline with two new programs. The pandemic influenza adjuvant program will evaluate CpG 1018 in an H5N1 influenza vaccine as proof-of-concept for pandemic preparedness applications. This program leverages Dynavax's experience as a global supplier of CpG 1018 for COVID-19 vaccines and addresses the limited global supply of proven adjuvants. A Phase 1/2 study will initiate in Q2 2025, enrolling approximately 98 participants.
The Lyme disease vaccine program targets an area with no currently approved human vaccines. Dynavax believes its CpG 1018-adjuvanted approach could deliver a differentiated profile compared to other candidates in development that require three-dose primary series and annual boosters. This program is in IND-enabling studies with clinical development planned for 2027.
Additionally, Dynavax continues advancing its plague vaccine with the U.S. Department of Defense under a new $30 million agreement. A Phase 2 trial is expected to begin in Q3 2025. The company is also planning an observational retrospective cohort study to support an sBLA filing for HEPLISAV-B in adults on hemodialysis, potentially expanding the market for their commercial product.
These pipeline developments demonstrate how Dynavax is building multiple growth opportunities beyond its successful HEPLISAV-B franchise by applying its adjuvant platform across various disease targets with significant unmet needs.
- Record HEPLISAV-B® first quarter net product revenue of
$65 million 36% year-over-year growth - Top-line results in Part 1 of Phase 1/2 shingles vaccine trial expected in Q3 2025
- New pandemic influenza adjuvant program and Lyme disease vaccine programs planned to enter clinical development in 2025 and 2027, respectively
- Conference call today at 4:30 p.m. ET/1:30 p.m. PT
"We started 2025 off strong, executing across our strategic growth initiatives, including delivering our highest first quarter net product revenue for HEPLISAV-B to date, putting us on track to achieve the top half of our full year guidance range. We are also excited to advance our pipeline leveraging our leading vaccine adjuvant technology, CpG 1018, with key clinical trial milestones this year for our shingles and plague vaccine programs, while further broadening our pipeline with new programs in pandemic influenza and Lyme disease," said Ryan Spencer, Chief Executive Officer of Dynavax. "We continue to focus on maintaining a disciplined approach to capital allocation, including executing over
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 net product revenue of
$65.0 million 36% compared to$47.8 million - HEPLISAV-B total estimated market share in the
U.S. increased to approximately43% , compared to approximately41% for the first quarter 2024. - 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 and Preclinical 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 Part 1 of a Phase 1/2 clinical trial, a randomized, active-controlled, dose escalation, multicenter study, 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, Dynavax completed enrollment in Part 1, and anticipates reporting top-line immunogenicity and safety data in the third quarter of 2025.
- Dynavax plans to advance the selected vaccine formulation and regimen from Part 1 into Part 2 of the Phase 1/2 study in adults over age 70 years to generate clinical proof-of-concept in this key population, with key endpoints including tolerability and immunogenicity comparisons to Shingrix, ahead of advancement into a pivotal trial.
Plague Vaccine Program:
Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018 in collaboration with, and fully funded by, the
- In the fourth quarter of 2024, Dynavax and the DoD executed a new agreement for approximately
$30 million
Pandemic Influenza Adjuvant Program:
Dynavax is evaluating CpG 1018 in an adjuvanted H5N1 influenza vaccine as a proof-of-concept for its potential use with pandemic influenza vaccines.
- Pandemic influenza remains one of the most persistent and unpredictable global health threats. Vaccine adjuvants play an essential role in pandemic preparedness, mostly due to their dose sparing capability, yet despite their critical importance, the global supply of proven adjuvants remains limited.
- Leveraging its expertise and capabilities as a global supplier of CpG 1018 adjuvant for the development of multiple COVID-19 vaccines, Dynavax intends to generate clinical proof-of-concept for CpG 1018-adjuvanted pandemic influenza vaccines to support the potential commercial supply of vaccine adjuvant needed for global pandemic preparedness and response efforts.
- In the second quarter of 2025, Dynavax expects to initiate a randomized, active-controlled Phase 1/2 study to evaluate the safety and immunogenicity of an investigational H5N1 influenza vaccine adjuvanted with CpG 1018.
- Part 1 of the Phase 1/2 trial is expected to enroll approximately 98 participants aged 18 to 49 years to receive either single-dose or two-dose formulations of the investigational vaccine, with the intention to select the optimal formulations of CpG 1018 adjuvant for Part 2 of the Phase 1/2 trial.
Lyme Disease Vaccine Program:
Dynavax is developing an investigational multivalent protein subunit vaccine candidate adjuvanted with CpG 1018 for the prevention of Lyme disease, a bacterial infection that is the most common vector-borne illness in the Northern Hemisphere.
- There are currently no approved human vaccines for Lyme disease, and current vaccine candidates in clinical development require three-dose primary series and annual boosters. Dynavax believes its investigational Lyme disease vaccine adjuvanted with CpG 1018, which has a demonstrated ability to amplify immune responses and improve durability of protection, has the potential for a differentiated and best-in-class vaccine profile.
- Dynavax's Lyme disease vaccine candidate has progressed into Investigational New Drug (IND)-enabling studies, with plans to initiate clinical development in 2027.
HEPLISAV-B for Adults on Hemodialysis:
- Dynavax plans to conduct an observational retrospective cohort study to support its sBLA filing for a HEPLISAV-B® vaccine regimen for adults on hemodialysis. In the first quarter of 2025, Dynavax received feedback from the
U.S. Food and Drug Administration (FDA) that its proposed patient database may be acceptable for the observational retrospective cohort study, and Dynavax is engaging with the FDA to finalize the study protocol.
FIRST QUARTER 2025 FINANCIAL HIGHLIGHTS
- Total revenues were
$68.2 million 34% increase compared to$50.8 million - HEPLISAV-B net product revenue was
$65.0 million 36% increase compared to$47.8 million - Cost of sales - product for HEPLISAV-B were
$13.8 million $11.0 million - Research and development expenses (R&D) were
$19.4 million $13.5 million - Selling, general, and administrative expenses (SG&A) were
$47.7 million $44.1 million - Bad debt expense: During the first quarter of 2025, Dynavax recorded an allowance for doubtful accounts of
$11.0 million - GAAP net loss was
$96.1 million $0.77 $8.7 million $0.07 - Adjusted EBITDA* was negative
$4.4 million $6.8 million - Cash, cash equivalents and marketable securities were
$661.3 million $713.8 million - Convertible debt refinancing: In March 2025, Dynavax refinanced a majority of its outstanding convertible senior notes, which extended the maturity date of most of its existing debt, lowered its overall cost of capital through improved terms, and reduced basic and diluted shares outstanding.
- Share repurchase program: In November 2024, Dynavax announced a
$200 million $100 million $172 million $200 million
FULL YEAR 2025 FINANCIAL GUIDANCE
Dynavax is reaffirming its full year 2025 financial guidance, based on its current operating plan:
- HEPLISAV-B net product revenue is expected in the range of
$305 $325 million - Adjusted EBITDA* 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 Tuesday, May 6, 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 Dynavax'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.
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. Dynavax has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the
Non-GAAP Financial Measures
To supplement financial results presented on a GAAP basis, Dynavax has included information about adjusted EBITDA, a non-GAAP financial measure. Dynavax believes the presentation of this non-GAAP financial measure, when viewed with its results under GAAP and the accompanying reconciliation, provide analysts, investors and other third parties with insights into how Dynavax evaluates normal operational activities, including its ability to generate cash from operations, on a comparable year-over-year basis, and manage its budgeting and forecasting.
In quarterly and annual reports, earnings press releases and conference calls, Dynavax may discuss Adjusted EBITDA to supplement its 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 Dynavax's business but do not represent ongoing operations, including loss on debt extinguishment and proxy contest costs. Adjusted EBITDA, as used by Dynavax, 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;
- Dynavax excludes 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 its business and an important part of its compensation strategy; and (ii) if Dynavax did not pay out a portion of its compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect its cash position;
- From time to time, Dynavax may exclude other expenses that are episodic in nature and do not directly correlate to the cost of operating its business on an ongoing basis, such as loss on debt extinguishment and proxy contest costs.
Reconciliation of each historical non-GAAP financial measure to Adjusted EBITDA can be found in the table accompanying this press release. The Company has not provided a reconciliation of its full-year 2025 guidance for Adjusted EBITDA to the most directly comparable forward-looking GAAP measures because the Company is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, income tax expense or provision for income taxes. These items are uncertain and depend on various factors that are outside of the Company's control or cannot be reasonably predicted. While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income for the guidance period. A reconciliation of Adjusted EBITDA would imply a degree of precision and certainty as to these future items that does not exist and could be confusing to investors.
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," "potential," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding Dynavax's expected financial results for the quarter ended March 31, 2025, expectations regarding its 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 Dynavax's business, including, the risk that market size or actual demand for its products may differ from its expectations, risks relating to its 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 its Quarterly Report on Form 10-Q for the three months ended March 31, 2025 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in its 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 | |||
2025 | 2024 | ||
Revenues: | |||
Product revenue, net | $ 64,959 | $ 47,845 | |
Other revenue | 3,205 | 2,945 | |
Total revenues | 68,164 | 50,790 | |
Operating expenses: | |||
Cost of sales - product | 13,769 | 10,966 | |
Research and development | 19,377 | 13,528 | |
Selling, general and administrative | 47,678 | 44,065 | |
Bad debt expense | 10,970 | — | |
Total operating expenses | 91,794 | 68,559 | |
Loss from operations | (23,630) | (17,769) | |
Other income (expense): | |||
Interest income | 7,739 | 9,468 | |
Interest expense | (1,692) | (1,695) | |
Sublease income (expense) (Note 5) | 2,226 | (1,602) | |
Loss on debt extinguishment | (82,095) | — | |
Other (loss) income | (423) | 101 | |
Net loss before income taxes | (97,875) | (11,497) | |
Benefit from income taxes | 1,776 | 2,776 | |
Net loss | $ (96,099) | $ (8,721) | |
Net loss per share attributable to common stockholders | |||
Basic | $ (0.77) | $ (0.07) | |
Diluted | $ (0.77) | $ (0.07) | |
Weighted-average shares used in computing net loss per share attributable | |||
Basic | 124,871 | 130,200 | |
Diluted | 124,871 | 130,200 | |
DYNAVAX TECHNOLOGIES CORPORATION | |||
March 31, | December 31, | ||
Assets | |||
Cash, cash equivalents and marketable securities | $ 661,336 | $ 713,834 | |
Inventories | 74,403 | 70,054 | |
Other current assets | 80,231 | 65,053 | |
Total current assets | 815,970 | 848,941 | |
Total non-current assets | 129,958 | 137,315 | |
Total assets | $ 945,928 | $ 986,256 | |
Liabilities and stockholders' equity | |||
Total current liabilities | $ 68,379 | $ 78,634 | |
Total long-term liabilities | 346,608 | 310,823 | |
Stockholders' equity | 530,941 | 596,799 | |
Total liabilities and stockholders' equity | $ 945,928 | $ 986,256 | |
DYNAVAX TECHNOLOGIES CORPORATION | |||
Three Months Ended | |||
March 31, | |||
2025 | 2024 | ||
GAAP net loss | $ (96,099) | $ (8,721) | |
Adjustments: | |||
Depreciation & amortization | 374 | 375 | |
Interest income | (7,739) | (9,468) | |
Interest expense | 1,692 | 1,695 | |
Benefit from income taxes | (1,776) | (2,776) | |
Total adjustments | (7,449) | (10,174) | |
EBITDA | (103,548) | (18,895) | |
Stock-based compensation | 13,449 | 12,144 | |
Loss on debt extinguishment | 82,095 | — | |
Proxy contest costs | 3,648 | — | |
Adjusted EBITDA | $ (4,356) | $ (6,751) | |
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SOURCE Dynavax Technologies
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