Dynavax Announces Fourth Quarter and Full Year 2020 Financial Results
Dynavax Technologies (DVAX) reported its financial results for Q4 and full year 2020, highlighting a net loss of $15.5 million in Q4, improved from a loss of $36.8 million in Q4 2019. Total revenues rose to $46.6 million for 2020, up from $35.2 million in 2019. HEPLISAV-B product revenue reached $36 million, a 4% increase year-over-year. The company anticipates significant revenue from collaborations utilizing its adjuvant CpG 1018, potentially generating up to $230 million in 2021. Cash reserves stood at $165 million at the end of 2020.
- Full year 2020 net product revenue for HEPLISAV-B increased to $36 million, up 4% year-over-year.
- Total revenues for 2020 improved to $46.6 million from $35.2 million in 2019.
- Market share for HEPLISAV-B increased to 26% in targeted accounts, up from 20% in Q4 2019.
- Potential revenue of up to $230 million from CpG 1018 collaboration in 2021.
- Net loss for Q4 2020 was $15.5 million, despite improvements from Q4 2019.
- Research and development expenses decreased significantly, indicating a potential slowdown in innovation.
- Full year 2020 net loss was $75.2 million, a decrease but still considerable.
EMERYVILLE, Calif., Feb. 25, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the fourth quarter and full year 2020.
"2020 was an important year for Dynavax as we continue to build a leading vaccine company underpinned by growing recurring revenue from both HEPLISAV-B and CpG 1018," commented Ryan Spencer, Chief Executive Officer of Dynavax. "In addition to HEPLISAV-B, we continue to progress numerous collaborations to develop our proven vaccine adjuvant CpG 1018 across multiple indications, including COVID–19, pertussis, and universal flu."
Mr. Spencer added, "Our COVID-19 collaborations have advanced significantly in recent months with multiple partners targeting emergency use authorization in the second half of 2021. The emerging portfolio of product opportunities with CpG 1018 has the potential to drive significant revenue growth in 2021 and beyond. Through the continued advancement of our multiple collaborations, CpG 1018 could be utilized in up to 500 million to 1.5 billion doses of vaccine annually starting in 2022, with additional capacity expansion available depending on global demand."
HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]
- Full year 2020 net product revenue of
$36.0 million compared to$34.6 million for full year 2019, a4% year-over-year growth rate despite the substantial ongoing reduction in market utilization due to the pandemic and COVID-19 vaccine rollout. - Net product revenue for HEPLISAV-B during the fourth quarter 2020 was
$11.5 million , up8.5% year-over-year from$10.6 million for the fourth quarter of 2019. - Market share in accounts targeted by the field sales team increased to
26% , up from20% market share in the fourth quarter of 2019. - Received Marketing Authorization in February 2021 from the European Commission following the positive opinion in December 2020 from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
- Reported final immunogenicity data from a study in adults with end-stage renal disease (ESRD) undergoing hemodialysis. In this study of 119 patients, HEPLISAV-B demonstrated a high seroprotection rate of
89.3% at week 20 after 4 standard doses.
CpG 1018 (Advanced Vaccine Adjuvant)
- Dynavax is scheduled to supply CpG 1018 to produce up to 100 million doses of Valneva's SE adjuvanted COVID-19 vaccine in 2021, which would generate CpG 1018 revenue of up to
$230 million in 2021, contingent on the continued success of Valneva's vaccine candidate. - First quarter 2021 CpG revenue is anticipated to be between
$40 million and$60 million . - Clover Biopharmaceuticals is initiating a global Phase 2/3 efficacy trial with their protein sub–unit COVID-19 vaccine candidate adjuvanted with CpG 1018 with an interim analysis for vaccine efficacy expected in the middle of 2021.
- Coalition for Epidemic Preparedness Innovations (CEPI) agreed to provide funding of up to
$99 million for advanced manufacturing of CpG 1018 for use in COVID–19 vaccines developed by CEPI grantees to ensure product availability in 2021 upon emergency use authorization. - Dynavax dosed the first participant in a Phase 1 clinical trial evaluating a tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine candidate adjuvanted with CpG 1018.
Additional Corporate Updates
- Appointed Kelly MacDonald as Senior Vice President and Chief Financial Officer
- Dong Yu, Ph.D., joined as Senior Vice President of Vaccine Research
2021 Milestones
- Publication of data from the study of HEPLISAV-B in patients on hemodialysis anticipated in the first half
- Multiple data readouts from our CpG 1018 collaboration partners throughout the year
- Final report for HEPLISAV-B post-marketing study expected in the second quarter
- Data from the ongoing Phase 1 study of an improved Tdap vaccine candidate adjuvanted with CpG 1018 anticipated in the fourth quarter
- Launch HEPLISAV-B in the EU in the fourth quarter
Financial Results
Total Revenues and Product Revenue, Net. Total revenues for the fourth quarter of 2020 were
Cost of Sales - Product. Cost of sales - product for the fourth quarter 2020 increased to
Research and Development Expenses. Research and development (R&D) expenses for the fourth quarter of 2020 decreased to
SG&A Expenses. Selling, general and administrative (SG&A) expenses for the fourth quarter of 2020 decreased to
Loss from Operations and Net Income Loss. Loss from operations for the fourth quarter of 2020 decreased to
Cash Position. Cash, cash equivalents and marketable securities totaled
Conference Call and Webcast Information
Dynavax will hold a conference call today 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 www.dynavax.com. Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 8380559. A replay of the webcast will be available for 30 days following the live event.
Please see Important Safety Information below.
For more information about HEPLISAV-B, visit http://heplisavb.com.
About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv
About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Important Safety Information (ISI)
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 (
For full Prescribing Information for HEPLISAV-B, click here.
About CpG 1018
CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.
About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.
Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding the potential for HEPLISAV-B to become the standard of care adult hepatitis B vaccine in the U.S., establishing CpG 1018 as a leading adjuvant, the development of vaccines containing CpG 1018 and potential future sales of CpG 1018, expected revenue for the first fiscal quarter of 2021, expected full-year revenue from Valneva, the launch of HEPLISAV-B in Europe, the timing of initiation and completion of clinical studies and the publication of results, the timing of our collaborators seeking emergency use authorization of COVID-19 vaccines containing CpG 1018, our ability to scale manufacturing capacity, the expected demand for our products, our efforts to develop an improved pertussis vaccine, a vaccine for COVID-19, and a universal flu vaccine, entering into strategic relationships and expected results of such relationships, and sales potential under certain agreements. 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 HEPLISAV-B may not become the standard of care adult hepatitis B vaccine in the U.S., risks related to whether and when prescribers and other key decision-makers at potential purchasing entities will make the decision to switch to HEPLISAV-B, and the timing and quantity of actual purchases, risks related to the timing of completion and results of current clinical studies of HEPLISAV-B, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018, and whether use of CpG 1018 will prove to be beneficial in these vaccines, risks related to whether, when and the quantity of CpG 1018 actually purchased by vaccine companies, risks related to the use of contract manufacturers to supply CpG 1018 and financial commitments made to them, and risks related to the launch of HEPLISAV B in Europe, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. 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.
Contacts:
Nicole Arndt, Senior Manager, Investor Relations
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.
iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.
iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-r
DYNAVAX TECHNOLOGIES CORPORATION | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(In thousands, except per share amounts) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenues, net | $ | 13,112 | $ | 10,558 | $ | 39,307 | $ | 34,644 | ||||||||
Other revenue | 6,438 | 12 | 7,244 | 575 | ||||||||||||
Total revenues | 19,550 | 10,570 | 46,551 | 35,219 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of sales - product | 4,058 | 2,407 | 11,410 | 10,172 | ||||||||||||
Cost of sales - amortization of intangible assets | - | 2,323 | 2,500 | 9,217 | ||||||||||||
Research and development | 9,549 | 12,269 | 28,607 | 62,331 | ||||||||||||
Selling, general and administrative | 17,838 | 20,318 | 79,256 | 74,986 | ||||||||||||
Gain on sale of assets | - | - | (6,851) | - | ||||||||||||
Restructuring | - | 642 | - | 13,356 | ||||||||||||
Total operating expenses | 31,445 | 37,959 | 114,922 | 170,062 | ||||||||||||
Loss from operations | (11,895) | (27,389) | (68,371) | (134,843) | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 70 | 766 | 1,260 | 3,370 | ||||||||||||
Interest expense | (4,805) | (4,866) | (19,062) | (16,977) | ||||||||||||
Sublease income | 1,927 | 1,728 | 7,706 | 2,619 | ||||||||||||
Change in fair value of warrant liability | (76) | (7,266) | 4,124 | (7,500) | ||||||||||||
Other | (688) | 271 | (897) | 731 | ||||||||||||
Net loss | $ | (15,467) | $ | (36,756) | $ | (75,240) | $ | (152,600) | ||||||||
Preferred stock deemed dividend | - | - | - | (3,267) | ||||||||||||
Net loss allocable to common stockholders | $ | (15,467) | $ | (36,756) | $ | (75,240) | $ | (155,867) | ||||||||
Basic net loss per share allocable to common stockholders | $ | (0.14) | $ | (0.44) | $ | (0.75) | $ | (2.16) | ||||||||
Weighted average shares used to compute basic net loss per share allocable to common stockholders | 110,176 | 83,868 | 100,753 | 72,024 | ||||||||||||
Diluted net loss per share allocable to common stockholders | $ | (0.14) | $ | (0.44) | $ | (0.78) | $ | (2.16) | ||||||||
Weighted average shares used to compute diluted net loss per share allocable to common stockholders | 110,176 | 83,868 | 101,504 | 72,024 | ||||||||||||
DYNAVAX TECHNOLOGIES CORPORATION | ||||||||
SELECTED BALANCE SHEET DATA | ||||||||
(In thousands) | ||||||||
(Unaudited) | ||||||||
December 31, | December 31, | |||||||
2020 | 2019 | |||||||
Assets | ||||||||
Cash, cash equivalents and marketable securities | $ | 165,036 | $ | 151,055 | ||||
Inventories, net | 63,689 | 41,332 | ||||||
Property and equipment, net | 30,567 | 32,022 | ||||||
Intangible assets, net | - | 2,500 | ||||||
Operating lease right-of-use assets | 26,583 | 30,252 | ||||||
Goodwill | 2,297 | 2,081 | ||||||
Other assets | 65,100 | 19,826 | ||||||
Total assets | $ | 353,272 | $ | 279,068 | ||||
Liabilities and stockholders' equity | ||||||||
Total current liabilities | $ | 77,411 | $ | 53,047 | ||||
Total long-term liabilities | 217,168 | 217,731 | ||||||
Stockholders' equity | 58,693 | 8,290 | ||||||
Total liabilities and stockholders' equity | $ | 353,272 | $ | 279,068 | ||||
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SOURCE Dynavax Technologies
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