Dynavax Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Full Year 2024 Financial Guidance
- HEPLISAV-B net product revenue increased by 69% year-over-year to $213 million in 2023.
- Market leader status achieved in key segments retail pharmacy and IDNs in 2023.
- Expected HEPLISAV-B net product revenue of $265 - $280 million in 2024.
- Cash position increased to $742 million at year-end 2023.
- Expect to be cash flow positive for the full year 2024.
- Strong financial position to drive value across the business and pursue growth opportunities.
- HEPLISAV-B market share increased to approximately 42% in the U.S. at the end of 2023.
- Pipeline programs advancing into clinical trial initiations and data readouts in 2024.
- Plague vaccine program in collaboration with the U.S. Department of Defense.
- Financial guidance for 2024 includes HEPLISAV-B net product revenue of $265 - $280 million.
- HEPLISAV-B gross margin expected to be approximately 80% for full year 2024.
- None.
Insights
The robust growth in net product revenue for HEPLISAV-B, reported by Dynavax Technologies Corporation, is a strong indicator of the company's increasing market penetration and dominance, particularly in the retail pharmacy and Integrated Delivery Networks (IDNs) segments. This growth is significant as it represents a substantial 69% increase year-over-year, which is likely to positively influence investor sentiment and potentially boost the company's stock price. The projected revenue for 2024 further underscores the company's confidence in the continued demand for its hepatitis B vaccine.
However, the absence of CpG 1018 adjuvant product revenue in 2023, compared to the previous year, indicates a shift in the company's revenue streams, which could raise concerns about the sustainability of revenue growth. Investors will need to monitor the company's ability to offset this loss with its current and pipeline products. The forecasted cash flow positivity in 2024 is a notable point, suggesting improved financial health and operational efficiency, which could be a pivotal factor for long-term investment considerations.
The achievement of a 42% market share in the U.S. for HEPLISAV-B and the expected growth of the U.S. hepatitis B vaccine market to approximately $800 million by 2027 are key metrics for understanding the company's market positioning and future potential. This growth trajectory is likely supported by the Centers for Disease Control and Prevention's Advisory Committee of Immunization Practices (ACIP) universal recommendation for adult hepatitis B vaccination. The growing market share in key segments indicates strong brand adoption and effective marketing strategies, which could lead to sustained revenue growth and a competitive edge in the market.
The anticipated supplemental Biologic License Application (sBLA) review by the FDA for HEPLISAV-B vaccination of adults on hemodialysis represents a potential expansion of the vaccine's addressable market, which could further bolster the company's financial performance if approved.
The expansion of Dynavax's clinical pipeline, leveraging the CpG 1018 adjuvant, showcases the company's commitment to innovation and the potential for future growth through new vaccine candidates. The development of vaccines for shingles, Tdap (tetanus, diphtheria and pertussis) and plague, with the latter being fully funded by the U.S. Department of Defense, reflects a diversified research and development strategy. This diversification could mitigate risks associated with reliance on a single product and open up new revenue streams upon successful clinical trial outcomes and regulatory approvals.
Investors should note the increased R&D expenses as an investment in the company's future growth, although it is crucial to balance these expenses with the potential for revenue generation from the pipeline products. The company's strategic collaborations and funding partnerships may also provide additional support and validation for its research initiatives.
- HEPLISAV-B® 2023 net product revenue grew
69% year-over-year to$213 million - Achieved market leader status in key segments retail pharmacy and IDNs in 2023
- 2024 HEPLISAV-B net product revenue expected to be
$265 $280 million - Cash position increased to
$742 million - Conference call today at 4:30 p.m. ET/1:30 p.m. PT
"2023 was characterized by record revenue growth for HEPLISAV-B, and the achievement of becoming the market share leader in the two largest growth segments, demonstrating important progress toward our goal of establishing HEPLISAV-B as the leading vaccine 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 vaccine net product revenue for the fourth quarter and full year 2023 were approximately
$51.1 million $213.3 million 46% and69% compared to the fourth quarter and full year 2022. - HEPLISAV-B total market share in the
U.S. increased to approximately42% at the end of 2023, compared to approximately35% at the end of 2022. - HEPLISAV-B market share in the retail pharmacy segment increased to approximately
58% at the end of 2023, compared to approximately42% at the end of 2022. HEPLISAV-B market share in the Integrated Delivery Networks (IDNs) and Large Clinics segment increased to approximately56% at the end of 2023, compared to approximately47% at the end of 2022. - A supplemental Biologic License Application (sBLA) for HEPLISAV-B vaccination of adults on hemodialysis is currently under review by the
U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date planned for May 13, 2024. - Driven by the Centers for Disease Control and Prevention's Advisory Committee of Immunization Practices (ACIP) universal recommendation for adult hepatitis B vaccination, the hepatitis B vaccine market continues to expand in the
U.S. and Dynavax believes the U.S. market has the potential to grow to approximately$800 million
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 and older.
- Dynavax recently submitted an Investigational New Drug Application (IND) to the
U.S. FDA to support initiation of a Phase 1/2 trial of Z-1018 in the first half of 2024.
Tdap vaccine program:
Tdap-1018 is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis (Tdap).
- Dynavax plans to submit an IND to the
U.S. FDA to support the initiation of a Phase 2 human challenge study of Tdap-1018 in the second half of 2024, upon completion of the independent study conducted by the Canadian Center for Vaccinology to establish the human challenge dose.
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 top line data for the randomized, active-controlled Phase 2 clinical trial evaluating immunogenicity, safety, and tolerability of the plague vaccine candidate in 2024.
FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL HIGHLIGHTS
Total Revenues and Net Product Revenue.
- HEPLISAV-B vaccine net product revenue was
$51.1 million $34.9 million $213.3 million $125.9 million - Other revenue was
$4.5 million $2.3 million $19.0 million $9.0 million U.S. Department of Defense. The increase was primarily driven by the advancement into a nonhuman primate challenge study. - No CpG 1018 adjuvant product revenue was recorded in the fourth quarter and full year 2023, compared to
$147.2 million $587.7 - Total revenues for the fourth quarter of 2023 were
$55.6 million $184.5 million $232.3 million $722.7 million
Cost of Sales - Product. Cost of sales - product for HEPLISAV-B the fourth quarter of 2023 decreased to
Research and Development Expenses (R&D). R&D expenses for the fourth quarter of 2023 increased to
Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the fourth quarter of 2023 increased to
Net Income. GAAP net income was
Cash and Marketable Securities. Cash, cash equivalents and marketable securities were
2024 FINANCIAL GUIDANCE
Dynavax is providing the following 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 agreement with Bavarian Nordic in Germany - HEPLISAV-B gross margin of approximately
80% for full year 2024 - Research and development expenses between approximately
$60 $75 million - Selling, general and administrative expenses between approximately
$160 $180 million - Expect to be cash flow positive for full year ended December 31, 2024
Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on Thursday, February 22, 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 U.S. Prescribing Information for HEPLISAV-B, click here.
Important U.S. Safety Information (ISI)
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 and quarter ended December 31, 2024, expectations regarding future growth and market share, and the timing of IND filings, initiation and completion of clinical studies, the publication of results, 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 Annual Report on Form 10-K for the year ended December 31, 2023 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 | |||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||
(In thousands, except per share amounts) | |||||||||||||
(Unaudited) | |||||||||||||
Three Months Ended | Year Ended | ||||||||||||
December 31, | December 31, | ||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||
Revenues: | |||||||||||||
HEPLISAV-B product revenue, net | $ | 51,086 | $ | 34,939 | $ | 213,295 | $ | 125,937 | |||||
CpG 1018 adjuvant product revenue, net | - | 147,244 | - | 587,708 | |||||||||
Other revenue | 4,510 | 2,309 | 18,989 | 9,038 | |||||||||
Total revenues | 55,596 | 184,492 | 232,284 | 722,683 | |||||||||
Operating expenses: | |||||||||||||
HEPLISAV-B cost of sales – product | 8,689 | 12,391 | 50,167 | 40,131 | |||||||||
CpG 1018 cost of sales – product | - | 65,097 | - | 222,022 | |||||||||
Research and development | 14,119 | 12,854 | 54,886 | 46,600 | |||||||||
Selling, general and administrative | 41,279 | 31,015 | 152,946 | 131,408 | |||||||||
Gain on sale of assets | - | - | (1,000) | (1,000) | |||||||||
Bad debt expense | - | - | 12,313 | - | |||||||||
Total operating expenses | 64,087 | 121,357 | 269,312 | 439,161 | |||||||||
(Loss) income from operations | (8,491) | 63,135 | (37,028) | 283,522 | |||||||||
Other income (expense): | |||||||||||||
Interest income | 9,556 | 4,324 | 31,993 | 7,912 | |||||||||
Interest expense | (1,692) | (1,684) | (6,757) | (6,732) | |||||||||
Sublease income | 1,993 | 2,025 | 7,577 | 7,685 | |||||||||
Change in fair value of warrant liability | - | - | - | 1,801 | |||||||||
Other | (370) | 174 | (152) | 111 | |||||||||
Net income (loss) before income taxes | 996 | 67,974 | (4,367) | 294,299 | |||||||||
Provision for income taxes | (777) | (241) | (2,022) | (1,143) | |||||||||
Net income (loss) | $ | 219 | $ | 67,733 | $ | (6,389) | $ | 293,156 | |||||
Net income (loss) per share attributable to common | |||||||||||||
stockholders: | |||||||||||||
Basic (*) | $ | 0.00 | $ | 0.53 | $ | (0.05) | $ | 2.32 | |||||
Diluted (*) | $ | 0.00 | $ | 0.45 | $ | (0.05) | $ | 1.97 | |||||
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders: | |||||||||||||
Basic | 129,381 | 127,589 | 128,733 | 126,398 | |||||||||
Diluted | 133,278 | 151,728 | 128,733 | 150,797 | |||||||||
(*) GAAP net income per share (basic and diluted) was less than |
DYNAVAX TECHNOLOGIES CORPORATION | ||||||
SELECTED BALANCE SHEET DATA | ||||||
(In thousands) | ||||||
(Unaudited) | ||||||
December 31, | December 31, | |||||
2023 | 2022 | |||||
Assets | ||||||
Cash, cash equivalents and marketable securities | $ | 742,302 | $ | 624,395 | ||
Inventories | 53,290 | 59,446 | ||||
Other current assets | 63,528 | 233,144 | ||||
Total current assets | 859,120 | 916,985 | ||||
Total non-current assets | 137,976 | 68,865 | ||||
Total assets | $ | 997,096 | $ | 985,850 | ||
Liabilities and stockholders' equity | ||||||
Total current liabilities | $ | 62,195 | $ | 150,074 | ||
Total long-term liabilities | 312,829 | 254,763 | ||||
Stockholders' equity | 622,072 | 581,013 | ||||
Total liabilities and stockholders' equity | $ | 997,096 | $ | 985,850 | ||
View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-reports-fourth-quarter-and-full-year-2023-financial-results-and-provides-full-year-2024-financial-guidance-302068488.html
SOURCE Dynavax Technologies
FAQ
What was the year-over-year growth in HEPLISAV-B net product revenue in 2023?
What is the expected HEPLISAV-B net product revenue for 2024?
What was the cash position of Dynavax at the end of 2023?
What is the market share of HEPLISAV-B in the U.S. at the end of 2023?
What are the financial guidance figures for 2024 provided by Dynavax?
