Dynavax Announces First Quarter 2020 Financial Results
- Q1 2020 HEPLISAV-B® net product revenue of
$10.5 million, compared to $5.6 millionin Q1 2019
- Multiple collaborations established leveraging Dynavax’s vaccine adjuvant CpG 1018 in coronavirus (COVID-19) vaccine candidates across several technology platforms
- Positive interim clinical trial results for HEPLISAV-B® in dialysis patients
- Conference call to be held today at
4:30 p.m. ET/ 1:30 p.m. PT
“Now more than ever, the world is acutely aware of the crucial role vaccines play in protecting our families, communities, and those at high risk for infectious disease,” commented
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
- Despite sales reductions at the end of March due to coronavirus pandemic response,
Dynavaxachieved first quarter 2020 net product revenue of $10.5 million compared to $5.6 million for the first quarter of 2019. Dynavaxhas exceeded the HEPLISAV-B minimum product revenue covenant in its Term Loan Agreement of $30 millionfor the annual measurement period ending June 30, 2020.
- On-going clinical trial evaluating immunogenicity and safety of 4-dose regimen of HEPLISAV-B® in adults with end-stage renal disease (ESRD) who are initiating or undergoing hemodialysis:
- Seroprotection rate of 86.4% demonstrated in interim analysis of 44 patients
- Safety and efficacy have not been established in this population; full study data anticipated in the second half of 2020
- Protecting the health and safety of Dynavax’s employees and customers
- Ensuring access to HEPLISAV-B with a secure supply chain able to meet U.S. market demand
- Continuing to advance the Company’s on-going clinical trials of HEPLISAV-B
- Leveraging the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, in collaborations to develop additional adjuvanted vaccines.
Dynavaxhas established multiple such research collaborations to develop a coronavirus (COVID-19) vaccine:
|Inactivated Virus||Sinovac Biotech|
- Interim data from ongoing study of HEPLISAV-B in patients on hemodialysis reported in
April 2020; final immunogenicity data anticipated in the second half of 2020
- Completion of Phase 1-enabling animal studies and toxicology for an improved pertussis vaccine with CpG 1018
- Inclusion of CpG 1018 in at least one coronavirus vaccine advanced to Phase 1 clinical evaluation
- Entrance into multiple strategic relationships focused on initial research in a variety of vaccine candidates to establish CpG 1018 as a leading adjuvant
- Completion of safety follow-up for HEPLISAV-B post-marketing studies in Q4 2020
Product Revenue, Net. Product revenue, net increased to
Cost of Sales - Product. Cost of sales - product for the first quarter 2020 was
Research and Development Expenses. Research and development expenses for the first quarter of 2020 were
SG&A Expenses. Selling, general and administrative (SG&A) expenses for the first quarter of 2020 were
Net Loss. Net loss allocable for the first quarter of 2020 was
Cash Position. Cash, cash equivalents and marketable securities totaled
Conference Call and Webcast Information
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.
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.
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 (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).
For full Prescribing Information for HEPLISAV-B, click here.
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
Investor Relations Advisory Solutions
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
|Three Months Ended|
|Product revenue, net||$||10,514||$||5,627|
|Cost of sales – product||2,354||1,800|
|Cost of sales - amortization of intangible assets||2,298||2,273|
|Research and development||4,653||21,206|
|Selling, general and administrative||20,926||18,348|
|Total operating expenses||30,231||43,627|
|Loss from operations||(19,312||)||(37,854||)|
|Other income (expense):|
|Change in fair value of warrant liability||8,610||-|
|Other income (expense), net||322||181|
|Basic net loss per share||$||(0.15||)||$||(0.62||)|
|Weighted average shares used to compute basic net loss per share||85,477||63,778|
|Diluted net loss per share||$||(0.25||)||$||(0.62||)|
|Weighted average shares used to compute diluted net loss per share||85,648||63,778|
SELECTED BALANCE SHEET DATA
|Cash, cash equivalents and marketable securities||$||129,533||$||151,055|
|Property and equipment, net||30,897||32,022|
|Intangible assets, net||202||2,500|
|Operating lease right-of-use assets||28,436||30,252|
|Liabilities and stockholders’ equity|
|Total current liabilities||$||29,279||$||53,047|
|Total long-term liabilities||218,153||217,731|
|Total liabilities and stockholders’ equity||$||259,256||$||279,068|
Source: Dynavax Technologies Corporation