- Generated quarterly HEPLISAV-B® vaccine net
product revenue of $62.3 million, a
66% year-over-year increase
- Raising full year HEPLISAV-B net product revenue guidance to
$210 - $220
million, compared to prior range of $200 - $215
million
- Cash and investments increased to $720 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., Nov. 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
September 30, 2023.
"We're pleased to report yet another record quarter of
HEPLISAV-B revenue driven by continued market share growth and
overall expansion of the adult hepatitis B market, demonstrating
progress toward our goal of establishing HEPLISAV-B as the leading
adult hepatitis B vaccine in the U.S., a market opportunity we
believe will continue to expand to over $800
million by 2027," said Ryan
Spencer, Chief Executive Officer of Dynavax. "In addition to
HEPLISAV-B, we are focused on advancing our pipeline of innovative
vaccine candidates, pursuing strategic opportunities to accelerate
our growth, and continuing to drive strong financial performance,
reflecting the solid foundation we've established for sustained
success."
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 $62.3 million for the third quarter of 2023, an
increase of 66% compared to $37.5
million for the third quarter of 2022.
- HEPLISAV-B total market share in the U.S. increased to
approximately 41%, compared to approximately 32% at the end of the
third quarter of 2022.
- HEPLISAV-B market share in the Integrated Delivery Networks
(IDNs) and Large Clinics segment increased to approximately 54% at
the end of the third quarter of 2023, compared to approximately 43%
for the same quarter in 2022.
- HEPLISAV-B market share in the retail pharmacy segment
increased to approximately 53% at the end of the third quarter of
2023, compared to 43% for the same quarter in 2022.
- A supplemental Biologic License Application (sBLA) for
HEPLISAV-B vaccination of adults on hemodialysis is currently under
review by the U.S. Food and Drug Administration (FDA) with a
Prescription Drug User Fee Act (PDUFA) action date expected on
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 recently received Type B meeting feedback from the FDA
on the Z-1018 clinical development plan and expects to submit an
Investigational New Drug Application (IND) to the FDA to support
the 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 Investigational New Drug Application
(IND) to the FDA to support the initiation of a Phase 2 human
challenge study of Tdap-1018 in mid-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 and the U.S. Department of Defense recently executed a
contract modification to support advancement of the plague vaccine
candidate into a nonhuman primate challenge study, which was
initiated in August, with the agreement now totaling $33.7 million through 2025.
- Dosing has been completed in a randomized, active-controlled
Phase 2 clinical trial evaluating immunogenicity, safety, and
tolerability, with top line data anticipated in 2024.
THIRD QUARTER 2023 FINANCIAL HIGHLIGHTS
Total Revenues and Net Product Revenue.
- HEPLISAV-B vaccine net product revenue was $62.3 million for the third quarter of 2023,
compared to $37.5 million for the
third quarter of 2022, representing year-over-year growth of 66%.
The increase was primarily due to higher sales volume driven by
both continued improvement in market share and higher utilization
of adult hepatitis B vaccines related to the ACIP universal
recommendation.
- Other revenue was $7.2 million
for the third quarter of 2023, compared to $3.9 million in the same period of 2022. Other
revenue primarily includes revenue from our plague vaccine
agreement with the U.S. Department of Defense. The increase was
primarily driven by the advancement into a nonhuman primate
challenge study.
- No CpG 1018 adjuvant product revenue was recorded in the third
quarter of 2023, compared to $126.3
million in the third 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 third quarter of 2023 were $69.5 million, compared to $167.7 million for the third quarter of
2022.
Cost of Sales - Product. Cost of sales - product for
HEPLISAV-B in the third quarter of 2023 increased to
$13.2 million, compared to
$11.5 million for the
third quarter of 2022. The increase was primarily due to
higher sales volume driven by continued improvement in HEPLISAV-B
market share, offset by lower per-unit manufacturing costs as the
result of previous process improvements. Total cost of sales –
product for the third quarter of 2023 decreased to
$13.2 million, compared to
$61.3 million in the
third quarter of 2022. The decrease is primarily due to no CpG
1018 adjuvant cost of sales - product for the third quarter of
2023 as a result of completing all obligations and product delivery
under the prior CpG 1018 adjuvant collaboration agreements as of
December 31, 2022.
Research and Development Expenses (R&D). R&D
expenses for the third quarter of 2023 increased to $14.1 million, compared to $13.0 million for the third quarter of 2022. The
increase was primarily driven by continued investments in advancing
our clinical and preclinical development programs and
collaborations.
Selling, General, and Administrative Expenses (SG&A).
SG&A expenses for the third quarter of 2023 increased to
$38.1 million, compared to
$32.0 million for the
third 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 designed to
increase HEPLISAV-B market share and maximize the opportunities
presented by the ACIP's universal recommendation.
Net income. GAAP net income was $14.3 million, or $0.11 per share (basic) and $0.10 per share (diluted) in the third quarter of
2023, compared to GAAP net income of $63.8
million, or $0.50 per share
(basic) and $0.43 per share (diluted)
in the third quarter of 2022.
Cash and Marketable Securities. Cash, cash equivalents
and marketable securities were $720.4
million as of September 30,
2023.
2023 FINANCIAL GUIDANCE
Full year 2023 financial
guidance has been revised to consist of the following
expectations:
- HEPLISAV-B net product revenue between approximately
$210 - $220
million, compared to the prior range of approximately
$200 - $215
million.
- Research and development expenses between approximately
$50 - $60
million, compared to the prior range of approximately
$55 - $70
million.
- Selling, general and administrative expenses between
approximately $145 - $155 million, compared to the prior range of
approximately $135 - $155 million.
Conference Call and Webcast Information
Dynavax will
host a conference call and live audio webcast on Thursday, November 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.
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, our plans and strategies,
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 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 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
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2023
|
|
|
2022
|
|
2023
|
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HEPLISAV-B product
revenue, net
|
$
|
62,318
|
|
|
$
|
37,508
|
|
$
|
162,209
|
|
|
$
|
90,998
|
CpG 1018 adjuvant
product revenue, net
|
|
-
|
|
|
|
126,307
|
|
|
-
|
|
|
|
440,464
|
Other
revenue
|
|
7,196
|
|
|
|
3,920
|
|
|
14,479
|
|
|
|
6,729
|
Total
revenues
|
|
69,514
|
|
|
|
167,735
|
|
|
176,688
|
|
|
|
538,191
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HEPLISAV-B cost of
sales – product
|
|
13,229
|
|
|
|
11,511
|
|
|
41,478
|
|
|
|
27,740
|
CpG 1018 cost of sales
– product
|
|
-
|
|
|
|
49,823
|
|
|
-
|
|
|
|
156,925
|
Research and
development
|
|
14,116
|
|
|
|
12,962
|
|
|
40,767
|
|
|
|
33,746
|
Selling, general and
administrative
|
|
38,053
|
|
|
|
32,042
|
|
|
111,667
|
|
|
|
100,393
|
Gain on sale of
assets
|
|
(1,000)
|
|
|
|
-
|
|
|
(1,000)
|
|
|
|
(1,000)
|
Bad debt
expense
|
|
-
|
|
|
|
-
|
|
|
12,313
|
|
|
|
-
|
Total operating
expenses
|
|
64,398
|
|
|
|
106,338
|
|
|
205,225
|
|
|
|
317,804
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
5,116
|
|
|
|
61,397
|
|
(28,537)
|
|
|
220,387
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
8,462
|
|
|
|
2,562
|
|
|
22,437
|
|
|
|
3,588
|
Interest
expense
|
|
(1,691)
|
|
|
|
(1,685)
|
|
|
(5,065)
|
|
|
|
(5,048)
|
Sublease
income
|
|
1,993
|
|
|
|
2,026
|
|
|
5,584
|
|
|
|
5,660
|
Change in fair value of
warrant liability
|
|
-
|
|
|
|
-
|
|
|
-
|
|
|
|
1,801
|
Other
|
|
266
|
|
|
|
(208)
|
|
|
218
|
|
|
|
(63)
|
Net income (loss)
before income taxes
|
|
14,146
|
|
|
|
64,092
|
|
|
(5,363)
|
|
|
226,325
|
Benefit from (provision
for) income taxes
|
|
147
|
|
|
|
(283)
|
|
|
(1,245)
|
|
|
|
(902)
|
Net income
(loss)
|
$
|
14,293
|
|
|
$
|
63,809
|
|
$
|
(6,608)
|
|
|
$
|
225,423
|
Net income (loss)
per share attributable
to common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
stockholders:
|
|
Basic
|
$
|
0.11
|
|
|
$
|
0.50
|
|
$
|
(0.05)
|
|
|
$
|
1.79
|
Diluted
|
$
|
0.10
|
|
|
$
|
0.43
|
|
$
|
(0.05)
|
|
|
$
|
1.51
|
Weighted-average
shares used in
computing net income (loss) per share
attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
128,988
|
|
|
|
127,062
|
|
|
128,515
|
|
|
|
125,997
|
Diluted
|
|
154,196
|
|
|
|
151,538
|
|
|
128,515
|
|
|
|
150,433
|
DYNAVAX TECHNOLOGIES
CORPORATION SELECTED BALANCE SHEET
DATA (In thousands) (Unaudited)
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
2023
|
|
2022
|
Assets
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
720,416
|
|
$
|
624,395
|
Inventories
|
|
|
49,412
|
|
|
59,446
|
Other current
assets
|
|
|
65,838
|
|
|
233,144
|
Total current
assets
|
|
|
835,666
|
|
|
916,985
|
Total non-current
assets
|
|
|
137,267
|
|
|
68,865
|
Total
assets
|
|
$
|
972,933
|
|
$
|
985,850
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Total current
liabilities
|
|
$
|
54,264
|
|
$
|
150,074
|
Total long-term
liabilities
|
|
|
313,753
|
|
|
254,763
|
Stockholders'
equity
|
|
|
604,916
|
|
|
581,013
|
Total liabilities
and stockholders' equity
|
|
$
|
972,933
|
|
$
|
985,850
|
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SOURCE Dynavax Technologies