- Preliminary full year 2023 HEPLISAV-B®
vaccine net product revenue of approximately $213 million, a 69% year-over-year
increase
- Significant gains in HEPLISAV-B market share in key market
segments, with total U.S. market share increasing to
approximately 44% compared to approximately 35% at the end
of 2022
- Strengthened financial position with cash, cash equivalents
and marketable securities at year end increasing to
approximately $742 million;
expects to be cash flow positive for full year 2024
EMERYVILLE, Calif., Jan. 8, 2024
/PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq:
DVAX), a commercial-stage biopharmaceutical company developing
and commercializing innovative vaccines, today announced
preliminary, unaudited financial highlights for the fourth quarter
and full year ended December 31,
2023.
"In 2023, we delivered a record year of revenue for HEPLISAV-B,
driven by the expansion of the adult hepatitis B vaccine market in
the U.S., and our team's progress toward establishing HEPLISAV-B as
the market leading vaccine. We are extremely pleased with our
market share growth in the fourth quarter, which enabled us to
achieve our increased product revenue guidance for the year despite
the impact of expected seasonality due to increased focus on
respiratory disease vaccines during the fall and winter seasons. We
believe the seasonal market decline for adult hepatitis B vaccines
will be limited to the fourth quarter in line with the
administration of the vast majority of influenza and COVID-19
vaccines," said Ryan Spencer, Chief Executive Officer of
Dynavax. "Turning to this year, we believe HEPLISAV-B is
well-positioned entering 2024, supported by significant market
share gains in the total market and in key market segments. We
remain extremely confident in the long-term growth of the hepatitis
B market, with HEPLISAV-B expected to achieve a majority market
share in the U.S. In addition to HEPLISAV-B, we continue to advance
our pipeline of innovative vaccine candidates and continue to
pursue strategic opportunities to accelerate our growth."
Preliminary Fourth Quarter and Full Year 2023 Financial and
Commercial Highlights
- Preliminary HEPLISAV-B vaccine net product revenue for the
fourth quarter and full year 2023 were approximately $51 million and $213
million, respectively, representing year-over-year growth of
approximately 46% and 69% compared to the fourth quarter and full
year 2022.
- HEPLISAV-B total market share in the U.S. increased to
approximately 44%, compared to approximately 35% at the end of
2022.
- HEPLISAV-B market share in the retail pharmacy segment
increased to approximately 60%, compared to approximately 42% at
the end of 2022. HEPLISAV-B market share in the Integrated Delivery
Networks (IDNs) and Large Clinics segment increased to
approximately 58%, compared to approximately 47% at the end of
2022.
- Cash, cash equivalents and marketable securities were
approximately $742 million as of
December 31, 2023.
The preliminary selected financial results contained herein
are unaudited, subject to adjustment, and provided as an estimate
in advance of the Company's announcement of complete financial
results, for the three and twelve months ended December 31, 2023. Market share data are
preliminary and are as of the latest market data available on
December 22, 2023.
Expected Commercial and Pipeline Milestones
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted]
HEPLISAV-B vaccine is the first and only
adult hepatitis B vaccine approved in the U.S., the European Union
and Great Britain that enables
series completion with only two doses in one month. Hepatitis B
vaccination is universally recommended for adults aged 19-59 in the
U.S.
- Driven by the Centers for Disease Control and Prevention's
Advisory Committee of Immunization Practices (ACIP) universal
recommendation for adult hepatitis B vaccination, Dynavax continues
to expect the adult hepatitis B vaccine market in the U.S. to
expand at an annual growth rate of approximately 10 - 15% over the
next several years to a total market of approximately $800 million by 2027, one of the largest adult
vaccine markets in the U.S., with HEPLISAV-B well-positioned to
achieve a majority market share.
- A supplemental Biologic License Application (sBLA) for
HEPLISAV-B vaccination of adults on hemodialysis is currently under
priority 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.
Clinical Pipeline
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 expects to submit an Investigational New Drug
Application (IND) to the 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 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 Virology 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 U.S. Department of Defense.
- 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.
J.P. Morgan Healthcare Conference Presentation Webcast
Details
Dynavax will present at the 42nd Annual
J.P. Morgan Healthcare Conference on Thursday, January 11 at 11:15 a.m. PT.
The presentation will be webcast and may be accessed through the
"Events & Presentations" page on the "Investors" section of the
Company's website at
https://investors.dynavax.com/events-presentations.
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 (23% to 39%),
fatigue (11% to 17%), and headache (8% to 17%).
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
U.S., the European Union and Great
Britain for the prevention of infection caused by all known
subtypes of hepatitis B virus in adults 18 years of age and older,
and CpG 1018® adjuvant, currently used in multiple adjuvanted
COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a
premier vaccine adjuvant with adjuvanted vaccine clinical programs
for shingles and Tdap, and through global collaborations, currently
focused on adjuvanted vaccines for COVID-19, plague, seasonal
influenza and universal influenza. For more information about our
marketed products and development pipeline, visit
www.dynavax.com.
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, 2023, 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 Quarterly Report on Form 10-Q for the
quarter ended September 30, 2023 and
periodic filings made thereafter, as well as discussions of
potential risks, uncertainties and other important factors in our
other filings with the U.S. Securities and Exchange Commission.
These forward-looking statements are made as of the date hereof,
are qualified in their entirety by this cautionary statement and 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.
For Investors/Media:
Paul
Cox
pcox@dynavax.com
510-665-0499
Nicole Arnd
narndt@dynavax.com
510-665-7264
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SOURCE Dynavax Technologies