Dynavax Provides Business Update on COVID-19 Pandemic Impact
“During the uncertainty caused by the COVID-19 pandemic, we have acted quickly to focus on four key areas,” commented
Protecting Our Workforce and Minimizing the Spread of COVID-19
- The health and safety of Dynavax’s employees and customers is of paramount importance.
- The Company has implemented remote working operations for employees at its corporate offices in
Emeryville, California . - The Company’s manufacturing facility in
Dusseldorf, Germany is employing special measures to continue operations safely. Dynavax has shifted from in-person interactions by its field sales force to virtual field calls in order to allowDynavax to continue to serve the needs of physicians, patients, and customers during this critical time.
Ensuring Access to HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
Dynavax has a secure supply chain that is able to meet U.S. market demand for HEPLISAV-B.- The Company continues to produce hepatitis B surface antigen at its facility in
Dusseldorf, Germany . The Contract Manufacturing Organization (CMO), located in theU.S. , that produces the CpG 1018 adjuvant used in HEPLISAV-B remains capable of production.
- The Company continues to produce hepatitis B surface antigen at its facility in
Dynavax estimates it currently has inventory of finished drug product sufficient to meet more than one year of projected demand and drug substance to fulfill approximately an additional year of estimated demand.
Continuing to Advance Clinical Trials of HEPLISAV-B
- HEPLISAV-B post marketing observational studies are fully enrolled and continuing uninterrupted. Due to the design and conduct of the studies, the Company does not anticipate an impact to the integrity of the studies as a result of the “shelter in place” mandates in
California . - HEPLISAV-B dialysis study continues to enroll patients. The study is focused on patients entering dialysis treatment, which is classified under the ‘essential travel’ exemptions and therefore will continue during this period of reduced medical services. The Company anticipates reporting data from the study’s interim analysis later this month (April). This data was selected for presentation at the 2020 Annual Conference on Vaccinology Research (ACVR), which has been cancelled.
Delivering on the Promise of CpG 1018
Dynavax has been actively pursuing opportunities to collaborate with other organizations on the development of additional vaccines, including a COVID-19 vaccine, by leveraging the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, the adjuvant used in HEPLISAV-B, an adult hepatitis B vaccine approved by theU.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 with a significant safety database, potentially accelerating the development and large-scale manufacturing of vaccines for emerging pathogens, such as pandemic influenza and coronavirus.- The Company has recently announced multiple collaborations focused on COVID-19, including with the
Coalition for Epidemic Preparedness Innovations (CEPI), theUniversity of Queensland , and Clover Biopharmaceuticals, and continues to work to identify other programs where CpG 1018 can be utilized to enhance the immune response to a coronavirus vaccine. The Company and its CMO are developing plans for scale-up activities to support pandemic level of production of CpG 1018 adjuvant, as necessary to support the Company’s multiple collaborations to develop a coronavirus vaccine.
Updating Our Business Outlook
- Although to date
Dynavax has seen limited financial impact from COVID-19 on HEPLISAV-B net product sales, the Company is seeing an impact on institutional access and vaccine utilization as many medical centers have closed clinics and are only providing care to the most severely affected patients. - Due to uncertainties about the duration and effect of the COVID-19 pandemic and the potential impact on HEPLISAV-B product sales, the Company is withdrawing its full-year guidance for 2020 HEPLISAV-B® net product sales.
Dynavax estimates it has already exceeded the HEPLISAV-B minimum product revenue covenant in its Term Loan Agreement of$30 million for the annual measurement period endingJune 30, 2020 .
About
Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding financial estimates which are preliminary, based on unaudited financial results, subject to change upon completion of our audit, and may differ from what will be reflected in our consolidated financial statements for the quarter ended
Contacts -
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510-665-7264
Investor Relations Advisory Solutions
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Source: Dynavax Technologies Corporation