- Generated record quarterly HEPLISAV-B® vaccine
net product revenue of $56 million, a
73% year-over-year increase
- Full year HEPLISAV-B net product revenue guidance
raised to $200 -
$215 million, compared to prior range
of $165 - $185
million
- Cash and investments increased to $682 million at quarter end; expects positive
free cash flow for full year
- Conference call today at 4:30 p.m.
ET/1:30 p.m. PT
EMERYVILLE, Calif., Aug. 3, 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
June 30, 2023.
"This quarter's impressive HEPLISAV-B revenue growth reflects
the continued expansion of the hepatitis B vaccine market and our
team's success in capturing market share. As a result of the strong
HEPLISAV-B performance in the first half of 2023, which exceeded
expectations, and the growing enthusiasm that we see in the market,
we are significantly raising our revenue expectations for the full
year," said Ryan Spencer, Chief Executive Officer of
Dynavax.
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 $56.4 million for the second quarter of 2023, an
increase of 73% compared to $32.7
million for the second quarter of 2022.
- HEPLISAV-B total market share increased to approximately 39%,
compared to approximately 32% at the end of the second quarter of
2022.
- HEPLISAV-B market share in the Integrated Delivery Networks
(IDNs) and Clinics segment was approximately 53% at the end of the
second quarter of 2023, compared to approximately 39% for the same
quarter in 2022.
- HEPLISAV-B maintained a strong market share of 45% in the
retail segment at the end of the second quarter of 2023, compared
to 46% for the same quarter in 2022.
- The U.S. Food and Drug Administration (FDA) recently accepted
the supplemental Biologics License Application (sBLA) for
HEPLISAV-B vaccination of adults on hemodialysis with a
Prescription Drug User Fee Act (PDUFA) action date of May 13, 2024.
- 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 see the expansion of the hepatitis B vaccine market and believes
HEPLISAV-B has the potential to expand the U.S. market to over
$800 million by 2027, with HEPLISAV-B
well-positioned to achieve a majority market share.
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.
- In June, Dynavax presented results from a Phase 1 randomized,
active-controlled, dose escalation, multicenter trial to evaluate
the safety, tolerability, and immunogenicity of Z-1018, at the
National Foundation for Infectious Diseases' 2023 Annual Conference
on Vaccinology Research. These results demonstrate the opportunity
to develop a shingles vaccine with improved vaccine tolerability
and comparable efficacy to Shingrix and support the continued
development of Dynavax's shingles vaccine candidate.
- In the second half of 2023, Dynavax plans to assess the
regulatory pathway with the FDA to support the initiation of a
Phase 1/2 trial in early 2024.
Tdap vaccine program:
Tdap-1018 is an
investigational vaccine candidate intended for active booster
immunization against tetanus, diphtheria, and pertussis
(Tdap).
- Dynavax recently completed a pertussis challenge study in
nonhuman primates demonstrating protection from disease upon
challenge and robust Type 1 T helper (Th1) cell responses in
nonhuman primates vaccinated with Tdap-1018.
- The Company recently received Type B meeting feedback from the
FDA on the Tdap-1018 clinical development plan and plans to submit
an Investigational New Drug Application (IND) to the FDA in the
fourth quarter of 2023 to support the initiation of a human
challenge study.
Plague vaccine program:
DV2-PLG-01 is a plague
(rF1V) vaccine candidate currently in a Phase 2 clinical trial in
collaboration with, and fully funded by, the U.S. Department of
Defense.
- Earlier this year, the Company completed enrollment in Part 2
of the Phase 2 clinical trial, with top line data anticipated in
2024.
- In July, Dynavax and the U.S. Department of Defense executed a
contract modification to support advancement into a nonhuman
primate challenge study, with the agreement now totaling
$33.7 million through 2025.
CORPORATE UPDATES
- Dynavax recently established a Scientific Advisory Board (SAB)
comprised of renowned leaders in vaccine research and development.
The SAB will work closely with Dynavax's leadership team on its
efforts to develop innovative vaccines, as well support the
evaluation of new development and technology opportunities. The SAB
includes the following advisors:
-
- Chair: Peter Paradiso, Ph.D.,
Principal of Paradiso Biologics Consulting LLC, former Vice
President of New Business and Scientific Affairs, Pfizer
Vaccines
- Robert Coffman, Ph.D., Former
Chief Scientific Officer of Dynavax, Adjunct Professor of
Biomolecular Engineering, University of
California Santa Cruz, and member of the National Academy of
Sciences
- Kathryn Edwards, M.D., Professor
of Pediatrics Emerita, Former Director of the Vanderbilt Vaccine
Research Program, Vanderbilt University
School of Medicine, and member of the National Academy of Medicine
of the National Academy of Sciences
- Rino Rappuoli, Ph.D., Scientific Director of the Biotecnopolo
di Siena Foundation, former Chief Scientist and Head, External
R&D at GSK Vaccines, and member of the National Academy of
Sciences
- Dynavax has been recognized as a Great Place to Work in
the U.S. by Great Place To Work®.
SECOND QUARTER 2023 FINANCIAL HIGHLIGHTS
Total Revenues and Product Revenue, Net.
- HEPLISAV-B vaccine product revenue, net was $56.4 million for the second quarter of 2023,
compared to $32.7 million for the
second quarter of 2022, representing year-over-year growth of
73%.
- Other revenue was $3.8 million
for the second quarter of 2023, compared to $1.1 million in the same period of 2022.
- No CpG 1018 adjuvant product revenue was recorded in the second
quarter of 2023, compared to $222.6
million in the second 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.
- Total revenues for the second quarter of 2023 were $60.2 million, compared to $256.5 million for the second quarter of
2022.
Cost of Sales - Product. Total cost of sales – product
for the second quarter of 2023 decreased to $13.5 million, compared to $83.4 million in the second quarter of 2022. The
decrease is due to no CpG 1018 adjuvant cost of sales – product for
the second quarter of 2023 compared to $73.1 million in the second quarter of 2022. Cost
of sales - product for HEPLISAV-B in the second quarter of
2023 increased to $13.5 million,
compared to $10.3 million for the
second quarter of 2022. The increase was due to higher sales volume
driven by continued improvement in HEPLISAV-B market share and
utilization.
Research and Development Expenses (R&D). R&D
expenses for the second quarter of 2023 increased to $13.0 million, compared to $9.7 million for the second 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 second quarter of 2023 increased to
$37.1 million, compared to
$36.2 million for the second 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.
Net income. GAAP net income was $3.4 million, or $0.03 per share (basic and diluted) in the second
quarter of 2023, compared to GAAP net income of $128.8 million, or $1.02 per share (basic) and $0.87 per share (diluted) in the second quarter
of 2022.
Cash and Marketable Securities. Cash, cash equivalents
and marketable securities were $681.5
million as of June 30,
2023.
2023 FINANCIAL GUIDANCE
Full year 2023 financial
guidance has been revised to consist of the following
expectations:
- Raising HEPLISAV-B net product revenue between approximately
$200 - $215
million, compared to the prior range of approximately
$165 - $185
million
- Reiterating research and development expenses between
approximately $55 - $70 million
- Reiterating 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
Thursday, August 3, 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, the development and
potential approval of vaccines containing CpG 1018 adjuvant by us
or by our collaborators, the timing of IND filings, 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, as well as other risks detailed in the "Risk
Factors" section of our Annual Report on Form 10-Q for the quarter
ended June 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 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
|
|
Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2023
|
|
|
2022
|
|
2023
|
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues,
net
|
$
|
56,440
|
|
|
$
|
255,320
|
|
$
|
99,891
|
|
|
$
|
367,647
|
|
Other
revenue
|
|
3,809
|
|
|
|
1144
|
|
|
7,283
|
|
|
|
2809
|
|
Total
revenues
|
|
60,249
|
|
|
|
256,464
|
|
|
107,174
|
|
|
|
370,456
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales –
product
|
|
13,537
|
|
|
|
83,369
|
|
|
28,249
|
|
|
|
123,331
|
|
Research and
development
|
|
13,046
|
|
|
|
9,689
|
|
|
26,651
|
|
|
|
20,784
|
|
Selling, general and
administrative
|
|
37,071
|
|
|
|
36,179
|
|
|
73,614
|
|
|
|
68,351
|
|
Gain on sale of
assets
|
|
-
|
|
|
|
(1,000)
|
|
|
-
|
|
|
|
(1,000)
|
|
Bad debt
expense
|
|
-
|
|
|
|
-
|
|
|
12,313
|
|
|
|
-
|
|
Total operating
expenses
|
|
63,654
|
|
|
|
128,237
|
|
|
140,827
|
|
|
|
211,466
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
|
(3,405)
|
|
|
|
128,227
|
|
|
(33,653)
|
|
|
|
158,990
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
7,378
|
|
|
|
765
|
|
|
13,975
|
|
|
|
1,026
|
|
Interest
expense
|
|
(1,688)
|
|
|
|
(1,683)
|
|
|
(3,374)
|
|
|
|
(3,363)
|
|
Sublease
income
|
|
1,993
|
|
|
|
2,025
|
|
|
3,591
|
|
|
|
3,634
|
|
Change in fair value of
warrant liability
|
|
-
|
|
|
|
-
|
|
|
-
|
|
|
|
1,801
|
|
Other
|
|
(71)
|
|
|
|
40
|
|
|
(48)
|
|
|
|
145
|
|
Net income (loss)
before income taxes
|
|
4,207
|
|
|
|
129,374
|
|
|
(19,509)
|
|
|
|
162,233
|
|
Provision for income
taxes
|
|
(776)
|
|
|
|
(619)
|
|
|
(1,392)
|
|
|
|
(619)
|
|
Net income
(loss)
|
$
|
3,431
|
|
|
$
|
128,755
|
|
$
|
(20,901)
|
|
|
$
|
161,614
|
|
Net income (loss)
per share attributable to common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
stockholders:
|
|
|
Basic
|
$
|
0.03
|
|
|
$
|
1.02
|
|
$
|
(0.16)
|
|
|
$
|
1.29
|
|
Diluted
|
$
|
0.03
|
|
|
$
|
0.87
|
|
$
|
(0.16)
|
|
|
$
|
1.08
|
|
Weighted-average
shares used in computing net income (loss)
per share attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
128,625
|
|
|
|
126,347
|
|
|
128,275
|
|
|
|
125,456
|
|
Diluted
|
|
152,142
|
|
|
|
149,905
|
|
|
128,275
|
|
|
|
149,821
|
|
DYNAVAX TECHNOLOGIES
CORPORATION
SELECTED BALANCE
SHEET DATA
(In
thousands)
(Unaudited)
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
2023
|
|
2022
|
Assets
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
681,525
|
|
$
|
624,395
|
Inventories
|
|
|
53,088
|
|
|
59,446
|
Other current
assets
|
|
|
62,847
|
|
|
233,144
|
Total current
assets
|
|
|
797,460
|
|
|
916,985
|
Total non-current
assets
|
|
|
138,972
|
|
|
68,865
|
Total
assets
|
|
$
|
936,432
|
|
$
|
985,850
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Total current
liabilities
|
|
$
|
44,862
|
|
$
|
150,074
|
Total long-term
liabilities
|
|
|
314,365
|
|
|
254,763
|
Stockholders'
equity
|
|
|
577,205
|
|
|
581,013
|
Total liabilities
and stockholders' equity
|
|
$
|
936,432
|
|
$
|
985,850
|
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SOURCE Dynavax Technologies