Dynavax Provides Business Update on COVID-19 Pandemic Impact
April 02 2020 - 4:30PM
Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, today provided a business update in relation to the
impact of COVID-19 on the Company’s operations.
“During the uncertainty caused by the COVID-19
pandemic, we have acted quickly to focus on four key areas,”
commented Ryan Spencer, Chief Executive Officer of Dynavax. “These
include safeguarding the health and safety of our employees and
customers; continuing effective operations to ensure patient access
to HEPLISAV-B; maintaining our financial strength and stability;
and supporting efforts to develop a COVID-19 vaccine. The Company’s
long-term value proposition remains unchanged, despite these
short-term disruptions.”
Mr. Spencer commented further: “This global
health crisis reinforces the organization’s commitment to our
mission of developing vaccines to prevent infectious
diseases. We are hopeful that societal learnings from this
pandemic will increase support for adult immunization and highlight
the importance of providing rapid protection to our healthcare
workers and others who may be exposed to deadly viral diseases that
are preventable. The potential for all stakeholders - governments,
policy makers, healthcare systems, and consumers - to understand
the benefits of vaccines and prevention will have a significant
long-term positive impact on public health and the cost of
healthcare for everyone.”
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 allow Dynavax 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 the
U.S., that produces the CpG 1018 adjuvant used in HEPLISAV-B
remains capable of production.
- 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 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 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), the University 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 ending June 30,
2020.
About DynavaxDynavax is a
commercial stage biopharmaceutical company developing and
commercializing novel vaccines. The Company launched its first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], in February 2018, following U.S. FDA approval 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. For more information, visit
www.dynavax.com and follow the company on LinkedIn.
Forward-Looking StatementsThis
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
March 31, 2020, and regarding the Dynavax long-term value
proposition. Additional information and disclosures would be
required for a more complete understanding of our financial
position and results of operations as of March 31, 2020.
Actual results may differ materially from those set forth in
this press release due to the risks and uncertainties inherent in
vaccine research and development, including the timing of
completing development, the results of clinical trials, and whether
and when a new vaccine will be approved for use, 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, 2019 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 - DynavaxNicole Arndt, Senior Manager,
Investor Relationsnarndt@dynavax.com510-665-7264
Derek Cole, President Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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