- HEPLISAV-B® vaccine net product revenue
increased 109% year-over-year to $43.5
million in the first quarter of 2023
- Reaffirming HEPLISAV-B net product revenue guidance
for full year 2023 of between $165–$185 million,
representing annual revenue growth of 30-47%
- Strengthened balance sheet with cash and investments of
$652 million at quarter end and
expects positive free cash flow in 2023
- Conference call today at 4:30 p.m.
ET/1:30 p.m. PT
EMERYVILLE, Calif., May 2, 2023
/PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq:
DVAX), a commercial-stage biopharmaceutical company developing
and commercializing innovative vaccines, today reported
financial results and provided a business update for the quarter
ended March 31, 2023.
"We are excited to once again post record quarterly net product
revenue for HEPLISAV-B, which exceeded our expectations. We are
encouraged by the continued expansion of the total hepatitis B
vaccination market, along with the continued market share
gains of HEPLISAV-B, driven in part from the expanded ACIP
recommendation for adult hepatitis B vaccination," said Ryan
Spencer, Chief Executive Officer of Dynavax. "We expect these
tailwinds driving HEPLISAV-B growth to further improve this year,
while we also advance our clinical pipeline and continue to
evaluate strategic opportunities to accelerate growth through
disciplined use of our strong capital position."
BUSINESS UPDATES
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.
- HEPLISAV-B achieved net product revenue of $43.5 million for the first quarter of 2023, an
increase of 109% compared to $20.8
million for the first quarter of 2022.
- HEPLISAV-B total market share increased to approximately 37%,
compared to approximately 26% at the end of the first quarter of
2022.
- HEPLISAV-B market share in Integrated Delivery Networks (IDNs)
and Clinics increased to approximately 49%, compared to
approximately 33% at the end of the first quarter of 2022.
- HEPLISAV-B market share in the retail segment grew to 49% at
the end of the first quarter of 2023, up from 28% at end of the
first quarter of 2022.
- Dynavax continues to see a positive impact on HEPLISAV-B
revenue from the Centers for Disease Control and Prevention's
Advisory Committee of Immunization Practices (ACIP) universal
recommendation for adult hepatitis B vaccination, which we believe
has the potential to expand the market to over $800 million by 2027 with HEPLISAV-B
well-positioned to achieve a majority market-share.
- In February, the United
Kingdom's Medicines and Healthcare products Regulatory
Agency (MHRA) granted Marketing Authorization in Great Britain for HEPLISAV-B.
- In April, Dynavax submitted a supplemental Biologics License
Application (sBLA) to the U.S. Food and Drug Administration (FDA)
for HEPLISAV-B vaccination of adults on hemodialysis.
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.
Tetanus, diphtheria and pertussis (Tdap) vaccine
program:
- The Company has completed a Phase 1 clinical trial evaluating
its Tdap vaccine candidate adjuvanted with CpG 1018. Adult and
adolescent safety data from the trial demonstrated that the Tdap
vaccine candidate was well tolerated without observed safety
concerns. Immunogenicity results in adults were consistent with the
Company's expectations and support its plan to continue advancement
of this clinical program. These clinical results were presented at
ID Week 2022.
- Data from a non-human primate challenge study is anticipated in
mid-2023.
- The Company plans to initiate a human challenge study by the
end of 2023.
Shingles vaccine program:
- In January 2023, the Company
reported top line results from the Phase 1 clinical trial designed
to evaluate an investigational shingles vaccine, Z-1018, utilizing
different regimens of CpG 1018 adjuvant.
- An abstract featuring Phase 1 data results has been accepted
for oral presentation at the National Foundation for Infectious
Diseases' online 2023 Annual Conference on Vaccinology Research on
June 6, 2023.
- Based on these initial data, the Company plans to initiate a
Phase 1/2 study in early 2024 to evaluate various dose levels of
glycoprotein E (gE) plus CpG 1018 adjuvant.
Plague vaccine candidate funded by the Defense Department
(DoD):
- Part 1 of the Phase 2 clinical trial evaluating the
immunogenicity, safety, and tolerability in adults of a plague
(rF1V) vaccine candidate adjuvanted with CpG 1018 was successfully
completed in January 2023.
- Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint
and demonstrated a greater than two-fold increase in antibodies
over the alum adjuvanted control arm after two doses.
- The Company recently completed enrollment in Part 2 of the
Phase 2 clinical trial, with top line data anticipated in
2024.
FIRST QUARTER 2023 FINANCIAL HIGHLIGHTS
Total Revenues and Product Revenue, Net.
- Total revenues for the first quarter of 2023 were $46.9 million, compared to $114.0 million for the first quarter of
2022.
- HEPLISAV-B vaccine product revenue, net was $43.5 million for the first quarter of 2023,
compared to $20.8 million for the
first quarter of 2022, representing year-over-year growth of
109%.
- Other revenue was $3.5 million
for the first quarter of 2023, compared to $1.7 million in the same period of 2022,
primarily consisting of revenue related to the plague vaccine
program in collaboration with and fully funded by the U.S.
Department of Defense.
- No CpG 1018 adjuvant product revenue was recorded in the first
quarter of 2023, compared to $91.5
million in the first quarter of 2022, due to completion of
all obligations and product delivery under the Company's CpG 1018
adjuvant COVID-19 collaboration agreements as of December 31, 2022.
Cost of Sales - Product. Total cost of sales – product
for the first quarter of 2023 decreased to $14.7 million, compared to $40.0 million in the first quarter of 2022.
The decrease is due to no CpG 1018 adjuvant cost of sales – product
for the first quarter of 2023 compared to $34.0 million in the first quarter of 2022. Cost
of sales - product for HEPLISAV-B in the first quarter of 2023
increased to $14.7 million, compared
to $6.0 million for the first quarter
of 2022. The increase was due to higher sales volume driven by
continued improvement in HEPLISAV-B market share and utilization,
as well as certain one-time charges in connection with improvement
projects, and an inspection-related expense, at the Düsseldorf
manufacturing facility.
Research and Development Expenses (R&D). R&D
expenses for the first quarter of 2023 increased to $13.6 million, compared to $11.1 million for the first quarter of 2022. The
increase was primarily driven by continued investments in our
product candidates utilizing CpG 1018 adjuvant through preclinical
and clinical collaborations and additional discovery efforts.
Selling, General, and Administrative Expenses (SG&A).
SG&A expenses for the first quarter of 2023 increased to
$36.5 million, compared to
$32.2 million for the first quarter
of 2022. The increase was primarily driven by higher compensation
and related personnel costs and an overall increase in targeted
commercial and marketing efforts to increase market share and
maximize the ACIP's universal recommendation.
Bad Debt Expense. During the first quarter of 2023, the
Company recognized a bad debt expense of $12.3 million to reflect uncollectible
receivables from its customer, Biological E, in connection with the
CEPI Arrangement for Biological E supply of CORBEVAX® to the
Government of India. Among other
factors, the credit profile of Biological E has been negatively
impacted by its reliance on future cash collections from the
Government of India, which have
been significantly reduced and delayed in connection with decreased
demand for CORBEVAX in India. In
April 2023, Dynavax entered into an
amendment with Biological E to resolve remaining outstanding
payables from Biological E as well as an agreement with CEPI to
fully forgive the corresponding advance payments associated with
Biological E supply of CpG 1018.
Net loss. GAAP net loss was $24.3
million, or $0.19 per share
(basic and diluted) in the first quarter of 2023, compared to GAAP
net income of $32.9 million, or
$0.26 per share (basic) and
$0.22 per share (diluted) in the
first quarter of 2022.
Cash and Marketable Securities. Cash, cash
equivalents and marketable securities were $652.0 million as of March
31, 2023.
2023 FINANCIAL GUIDANCE
Full year 2023 financial guidance is reiterated and consists of
the following expectations:
- HEPLISAV-B net product revenue between approximately
$165 - $185
million
- Research and development expenses between approximately
$55 - $70
million
- Selling, general and administrative expenses between
approximately $135 - $155 million
Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on
Tuesday, May 2, 2023, 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
https://investors.dynavax.com/events-presentations. A replay of the
webcast will be available for 30 days following the live event.
To dial into the call, participants will need to register for
the call using the caller registration link. It is recommended that
participants dial into the conference call or log into the webcast
approximately 10 minutes prior to the call.
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
and follow Dynavax on LinkedIn and Twitter.
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," "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 financial guidance, planned clinical trials,
the development and potential approval of vaccines containing CpG
1018 adjuvant by us or by our collaborators, potential future sales
of CpG 1018 adjuvant or HEPLISAV-B vaccine, the timing of
initiation and completion of clinical studies and the publication
of results. 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 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, whether use of
CpG 1018 adjuvant will prove to be beneficial in these vaccines,
risks related to whether and when the quantity of CpG 1018 adjuvant
actually purchased by vaccine companies will meet our expectations,
as well as other risks detailed in the "Risk Factors" section of
our Annual Report on Form 10-K for the year ended December 31, 2022 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
917-754-0207
Nicole Arndt
narndt@dynavax.com
510-665-7264
DYNAVAX TECHNOLOGIES
CORPORATION
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
|
Three Months
Ended
|
|
|
March
31,
|
|
|
2023
|
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
Product revenues,
net
|
|
$
|
43,451
|
|
|
$
|
112,327
|
Other
revenue
|
|
|
3,474
|
|
|
|
1,665
|
Total
revenues
|
|
|
46,925
|
|
|
|
113,992
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of sales –
product
|
|
|
14,712
|
|
|
|
39,962
|
Research and
development
|
|
|
13,605
|
|
|
|
11,095
|
Selling, general and
administrative
|
|
|
36,543
|
|
|
|
32,172
|
Bad debt
expense
|
|
|
12,313
|
|
|
|
-
|
Total operating
expenses
|
|
|
77,173
|
|
|
|
83,229
|
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
|
|
(30,248)
|
|
|
|
30,763
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
|
|
6,597
|
|
|
|
261
|
Interest
expense
|
|
|
(1,686)
|
|
|
|
(1,680)
|
Sublease
income
|
|
|
1,598
|
|
|
|
1,609
|
Change in fair value of
warrant liability
|
|
|
-
|
|
|
|
1,801
|
Other
|
|
|
23
|
|
|
|
105
|
Net (loss) income
before income taxes
|
|
|
(23,716)
|
|
|
|
32,859
|
Provision for income
taxes
|
|
|
(616)
|
|
|
|
-
|
Net (loss)
income
|
|
$
|
(24,332)
|
|
|
$
|
32,859
|
Net (loss) income
per share attributable to common stockholders:
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.19)
|
|
|
$
|
0.26
|
Diluted
|
|
$
|
(0.19)
|
|
|
$
|
0.22
|
Weighted-average
shares used in computing net (loss) income per share attributable
to common stockholders:
|
|
|
|
|
|
|
|
Basic
|
|
|
127,921
|
|
|
|
124,555
|
Diluted
|
|
|
127,921
|
|
|
|
149,425
|
DYNAVAX TECHNOLOGIES
CORPORATION
|
SELECTED BALANCE
SHEET DATA
|
(In
thousands)
|
(Unaudited)
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
2023
|
|
2022
|
Assets
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
651,956
|
|
$
|
624,395
|
Inventories,
net
|
|
|
57,693
|
|
|
59,446
|
Other current
assets
|
|
|
120,492
|
|
|
233,144
|
Total current
assets
|
|
|
830,141
|
|
|
916,985
|
Total non-current
assets
|
|
|
139,781
|
|
|
68,865
|
Total
assets
|
|
$
|
969,922
|
|
$
|
985,850
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Total current
liabilities
|
|
$
|
91,515
|
|
$
|
150,074
|
Total long-term
liabilities
|
|
|
314,675
|
|
|
254,763
|
Stockholders'
equity
|
|
|
563,732
|
|
|
581,013
|
Total liabilities
and stockholders' equity
|
|
$
|
969,922
|
|
$
|
985,850
|
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SOURCE Dynavax Technologies