- Achieved record quarterly HEPLISAV-B® net product
revenue of $70.2 million,
growing 24% year-over-year
- Reaffirming full year 2024 HEPLISAV-B net product revenue
guidance of $265 - $280 million
- Initiated dosing in Phase 1/2 trial of novel shingles
vaccine program with clinical data expected in 2H 2025
- Conference call today at 4:30 p.m.
ET/1:30 p.m. PT
EMERYVILLE, Calif., Aug. 6, 2024
/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, 2024.
![(PRNewsfoto/Dynavax Technologies) (PRNewsfoto/Dynavax Technologies)](https://mma.prnewswire.com/media/1273133/Dynavax_Logo.jpg)
"We continue to strengthen our leadership position in the U.S.
adult hepatitis B vaccine market with another record quarter for
HEPLISAV-B, providing confidence in our current year expectations
and reaffirming our long-term view of the product opportunity. We
are highly optimistic about the adult hepatitis B vaccine market of
over 130 million eligible patients, which is one of the largest
addressable patient populations for vaccines in
the U.S. We expect the market opportunity for HEPLISAV-B
to grow to over $800 million by 2027,
and continue expanding through the end of the decade. The expected
growth in the market opportunity, combined with our expectations to
continue to increase market share, provides a substantial,
long-term revenue opportunity for HEPLISAV-B," said Ryan Spencer, Chief Executive Officer of
Dynavax.
"For our pipeline development, we are pleased to have recently
initiated our Phase 1/2 trial for our novel shingles vaccine
program, and remain excited for several upcoming milestones,
including data readouts from the shingles study as well as our Tdap
and plague vaccine programs expected across 2024 and 2025. In
addition to this progress, and bolstered by our strong financial
position, we continue to evaluate strategic opportunities to
accelerate growth, further diversify our portfolio, and deliver
value to our shareholders."
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 vaccine achieved record quarterly net product
revenue of $70.2 million for the
second quarter of 2024, an increase of 24% compared to $56.4 million for the second quarter of
2023.
- HEPLISAV-B total estimated market share in the U.S. increased
to approximately 42%, compared to approximately 39% for the second
quarter 2023.
- HEPLISAV-B estimated market share in the retail pharmacy
segment increased to approximately 59%, compared to approximately
45% for the second quarter of 2023. HEPLISAV-B estimated market
share in the Integrated Delivery Networks (IDNs) and Large Clinics
segment increased to approximately 56%, compared to approximately
53% for the second quarter 2023.
- Dynavax expects the HEPLISAV-B market opportunity in the U.S.
to expand to over $800 million by
2027, with growth expected to continue to a peak market opportunity
by 2030. Dynavax also expects HEPLISAV-B to achieve a majority
share of the total U.S. market by 2027, with share gains continuing
post-peak market. Additionally, Dynavax expects the HEPLISAV-B
market opportunity to remain substantial beyond 2030 due to the
ongoing penetration of the unvaccinated adult cohort.
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.
HEPLISAV-B for Adults on Hemodialysis
Dynavax
is developing a four-dose HEPLISAV-B® vaccine regimen for adults on
hemodialysis.
- In May 2024, Dynavax announced
that the U.S. Food and Drug Administration (FDA) issued a Complete
Response Letter (CRL) in response to the Company's supplemental
Biologics License Application (sBLA) to include a four-dose
HEPLISAV-B® vaccine regimen for adults on hemodialysis on the U.S.
label.
- The Company intends to meet with the FDA in the second half of
2024, as part of the standard post-CRL regulatory process, to
discuss pathways to amend its sBLA with additional data to support
the four-dose regimen for the adult hemodialysis population in the
U.S.
Shingles vaccine program:
Z-1018 is an
investigational vaccine candidate being
developed for the prevention of shingles in adults aged 50 years
and older.
- In June 2024, Dynavax announced
the initiation of a randomized, active-controlled, dose escalation,
multicenter Phase 1/2 trial to evaluate the safety, tolerability,
and immunogenicity of Z-1018 compared to Shingrix® in approximately
440 healthy adults aged 50 to 69.
- Dynavax anticipates reporting top line immunogenicity and
safety data in the second half of 2025, including a comparison of
CD4+ T-cells one month after the second of two vaccine doses.
Tdap vaccine program:
Tdap-1018 is an
investigational vaccine candidate intended for active booster
immunization against tetanus, diphtheria, and pertussis
(Tdap).
- Dynavax plans to evaluate the persistence of pertussis
immunogenicity of Tdap-1018 through a long-term follow-up study of
participants that completed a Phase 1 trial of a booster dose of
Tdap-1018 compared to an active control. The extension study is
expected to follow participants for up to three years following
initial vaccination. Results from the Phase 1 extension study are
expected in the fourth quarter of 2024.
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 providing a program update, based on
results from both a randomized, active-controlled Phase 2 clinical
trial and a nonhuman primate challenge study of the plague vaccine
candidate, in the fourth quarter of 2024.
SECOND QUARTER 2024 FINANCIAL HIGHLIGHTS
Total Revenues and Net Product Revenue.
- Total revenues for the second quarter of 2024 were $73.8 million, a 22% year-over-year increase
compared to $60.2 million for the
second quarter of 2023.
- HEPLISAV-B net product revenue was $70.2
million for the second quarter of 2024, a 24% year-over-year
increase compared to $56.4 million
for the second quarter of 2023.
- Other revenue was $3.6 million
for the second quarter of 2024, a 5% decrease compared to
$3.8 million for the second quarter
of 2023. Other revenue primarily includes revenue from the plague
vaccine agreement with the U.S. Department of Defense.
Cost of Sales - Product. Cost of sales - product for
HEPLISAV-B in the second quarter of 2024 decreased to $12.0 million, compared to $13.5 million for the second quarter of 2023. The
decrease was primarily due to lower per-unit manufacturing costs as
the result of previous process improvements.
Research and Development Expenses (R&D). R&D
expenses for the second quarter of 2024 increased to $15.0 million, compared to $13.0 million for the second quarter of 2023. The
increase was primarily driven by investments in our discovery,
preclinical and clinical pipeline efforts.
Selling, General, and Administrative Expenses (SG&A).
SG&A expenses for the second quarter of 2024 increased to
$41.7 million, compared to
$37.1 million for the second quarter
of 2023. The increase was primarily driven by increased headcount
and other investments supporting our strategic growth.
Net Income. Net income was $11.4 million, or $0.09 per share basic and $0.08 diluted in the second quarter of 2024,
compared to net income of $3.4
million, or $0.03 per share
(basic and diluted) in the second quarter of 2023.
Cash and Marketable Securities. Cash, cash equivalents
and marketable securities were $735.6
million as of June 30, 2024,
compared to $742.3 million as of
December 31, 2023.
2024 FINANCIAL GUIDANCE
Dynavax is reiterating its full year 2024 financial guidance,
based on the Company's current operating plan:
- HEPLISAV-B net product revenue between approximately
$265 - $280
million, including approximately $3
million in ex-U.S. sales through commercialization
partnership in Germany
- HEPLISAV-B gross margin of approximately 80%
- Research and development expenses between approximately
$60 - $75
million
- Selling, general and administrative expenses between
approximately $160 - $180 million
- Cash, cash equivalents and marketable securities to be higher
as of December 31, 2024, compared to
December 31, 2023
Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on
Tuesday, August 6, 2024, 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 HEPLISAV-B and multiple
adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 as a
premier vaccine adjuvant used in clinical programs for shingles and
Tdap, and in 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 ended December 31, 2024, expectations regarding our
future growth, extent and timing of market growth and market share
beyond 2024, 2027 and 2030, the timing of IND filings, initiation
and completion of clinical studies, expected timing for data
readouts, 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 three months ended June 30, 2024
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,
|
|
2024
|
|
|
2023
|
|
2024
|
|
|
2023
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
|
70,188
|
|
|
$
|
56,440
|
|
$
|
118,032
|
|
|
$
|
99,891
|
Other
revenue
|
|
3,607
|
|
|
|
3,809
|
|
|
6,552
|
|
|
|
7,283
|
Total
revenues
|
|
73,795
|
|
|
|
60,249
|
|
|
124,584
|
|
|
|
107,174
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales –
product
|
|
11,985
|
|
|
|
13,537
|
|
|
22,952
|
|
|
|
28,249
|
Research and
development
|
|
14,950
|
|
|
|
13,046
|
|
|
28,478
|
|
|
|
26,651
|
Selling, general and
administrative
|
|
41,662
|
|
|
|
37,071
|
|
|
85,727
|
|
|
|
73,614
|
Bad debt
expense
|
|
-
|
|
|
|
-
|
|
|
-
|
|
|
|
12,313
|
Total operating
expenses
|
|
68,597
|
|
|
|
63,654
|
|
|
137,157
|
|
|
|
140,827
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
5,198
|
|
|
|
(3,405)
|
|
(12,573)
|
|
|
(33,653)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
9,201
|
|
|
|
7,378
|
|
|
18,668
|
|
|
|
13,975
|
Interest
expense
|
|
(1,698)
|
|
|
|
(1,688)
|
|
|
(3,393)
|
|
|
|
(3,374)
|
Sublease
income
|
|
2,205
|
|
|
|
1,993
|
|
|
603
|
|
|
|
3,591
|
Other
|
|
-
|
|
|
|
(71)
|
|
|
103
|
|
|
|
(48)
|
Net income (loss)
before income taxes
|
|
14,906
|
|
|
|
4,207
|
|
|
3,408
|
|
|
(19,509)
|
Provision for income
taxes
|
|
(3,520)
|
|
|
|
(776)
|
|
|
(743)
|
|
|
|
(1,392)
|
Net income
(loss)
|
$
|
11,386
|
|
|
$
|
3,431
|
|
$
|
2,665
|
|
|
$
|
(20,901)
|
Net income (loss)
per share attributable to
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
stockholders:
|
|
Basic
|
$
|
0.09
|
|
|
$
|
0.03
|
|
$
|
0.02
|
|
|
$
|
(0.16)
|
Diluted
|
$
|
0.08
|
|
|
$
|
0.03
|
|
$
|
0.02
|
|
|
$
|
(0.16)
|
Weighted-average
shares used in computing net
income (loss) per share attributable to common
stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
130,916
|
|
|
|
128,625
|
|
|
130,551
|
|
|
|
128,275
|
Diluted
|
|
154,468
|
|
|
|
152,142
|
|
|
133,582
|
|
|
|
128,275
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DYNAVAX TECHNOLOGIES
CORPORATION
|
SELECTED BALANCE SHEET
DATA
|
(In thousands)
|
(Unaudited)
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
2024
|
|
2023
|
Assets
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
735,612
|
|
$
|
742,302
|
Inventories
|
|
|
62,462
|
|
|
53,290
|
Other current
assets
|
|
|
83,938
|
|
|
63,528
|
Total current
assets
|
|
|
882,012
|
|
|
859,120
|
Total non-current
assets
|
|
|
134,309
|
|
|
137,976
|
Total
assets
|
|
$
|
1,016,321
|
|
$
|
997,096
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Total current
liabilities
|
|
$
|
62,192
|
|
$
|
62,195
|
Total long-term
liabilities
|
|
|
311,280
|
|
|
312,829
|
Stockholders'
equity
|
|
|
642,849
|
|
|
622,072
|
Total liabilities
and stockholders' equity
|
|
$
|
1,016,321
|
|
$
|
997,096
|
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