- HEPLISAV-B® 2023 net product revenue grew
69% year-over-year to $213
million
- Achieved market leader status in key segments retail
pharmacy and IDNs in 2023
- 2024 HEPLISAV-B net product revenue expected to be
$265 - $280
million
- Cash position increased to $742
million at year end and expect to be cash flow
positive for full year 2024
- Conference call today at 4:30 p.m.
ET/1:30 p.m. PT
EMERYVILLE, Calif., Feb. 22,
2024 /PRNewswire/ -- Dynavax Technologies
Corporation (Nasdaq: DVAX), a commercial-stage
biopharmaceutical company developing and commercializing
innovative vaccines, today reported financial results for the
fourth quarter and full year ended December
31, 2023.
"2023 was characterized by record revenue growth for HEPLISAV-B,
and the achievement of becoming the market share leader in the two
largest growth segments, demonstrating important progress toward
our goal of establishing HEPLISAV-B as the leading vaccine in the
U.S. adult hepatitis B vaccine market," said Ryan
Spencer, Chief Executive Officer of Dynavax. "We expect 2024
to be an important year in building a vaccine portfolio of
best-in-class products, including further growing the HEPLISAV-B
brand as well as advancing our pipeline programs into clinical
trial initiations and data readouts. Importantly, our strong
financial position provides us with the optionality to continue to
build value across our business, including through investing to
drive the HEPLISAV-B market opportunity, advancing and expanding
our R&D efforts, and pursuing strategic opportunities to
accelerate our growth."
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 net product revenue for the fourth quarter
and full year 2023 were approximately $51.1
million and $213.3 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 42% at the end of 2023, compared to approximately 35%
at the end of 2022.
- HEPLISAV-B market share in the retail pharmacy segment
increased to approximately 58% at the end of 2023, 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 56% at the end of 2023, compared to
approximately 47% at the end of 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 planned for
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, the hepatitis B
vaccine market continues to expand in the U.S. and Dynavax believes
the U.S. market has the potential to grow to approximately
$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.
- Dynavax recently submitted an Investigational New Drug
Application (IND) to the U.S. 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 U.S. 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 Vaccinology 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.
FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL
HIGHLIGHTS
Total Revenues and Net Product Revenue.
- HEPLISAV-B vaccine net product revenue was $51.1 million for the fourth quarter of 2023,
compared to $34.9 million for the
fourth quarter of 2022, and $213.3
million for the full year 2023, compared to $125.9 million for the full year 2022.
- Other revenue was $4.5 million
for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022, and
$19.0 million for the full year 2023,
compared to $9.0 million for the full
year 2022. Other revenue primarily includes revenue from the 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
fourth quarter and full year 2023, compared to $147.2 million and $587.7 million in the same periods of 2022,
respectively, due to completion of all obligations and product
delivery under the Company's CpG 1018 adjuvant COVID-19
collaboration agreements as of the end of 2022.
- Total revenues for the fourth quarter of 2023 were $55.6 million, compared to $184.5 million for the fourth quarter of 2022,
and $232.3 million for the full year
2023, compared to $722.7 million for
the full year 2022.
Cost of Sales - Product. Cost of sales - product for
HEPLISAV-B the fourth quarter of 2023 decreased to $8.7 million, compared to $12.4 million for the fourth quarter of 2022, and
$50.2 million for the full year 2023,
compared to $40.1 million for the
full year 2022.
Research and Development Expenses (R&D). R&D
expenses for the fourth quarter of 2023 increased to $14.1 million, compared to $12.9 million for the fourth quarter of 2022, and
$54.9 million for the full year 2023,
compared to $46.6 million for the
full year 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 fourth quarter of 2023 increased to
$41.3 million, compared to
$31.0 million for the fourth quarter
of 2022, and $152.9 million for the
full year 2023, compared to $131.4
million for the full year 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 $0.2 million, or less than $0.01 per share (basic and diluted) in the fourth
quarter of 2023, compared to GAAP net income of $67.7 million, or $0.53 per share (basic) and $0.45 per share (diluted) in the fourth quarter
of 2022. GAAP net loss was $6.4
million, or $0.05 per share
(basic and diluted) for the full year 2023, compared to GAAP net
income of $293.2 million, or
$2.32 per share (basic) and
$1.97 per share (diluted) for the
full year 2022.
Cash and Marketable Securities. Cash, cash equivalents
and marketable securities were $742.3
million as of December 31,
2023.
2024 FINANCIAL GUIDANCE
Dynavax is providing the following 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 agreement
with Bavarian Nordic in Germany
- HEPLISAV-B gross margin of approximately 80% for full year
2024
- Research and development expenses between approximately
$60 - $75
million
- Selling, general and administrative expenses between
approximately $160 - $180 million
- Expect to be cash flow positive for full year ended
December 31, 2024
Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on
Thursday, February 22, 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
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, 2024,
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 Annual
Report on Form 10-K for the year ended December 31, 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
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2023
|
|
|
2022
|
|
2023
|
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HEPLISAV-B product
revenue, net
|
$
|
51,086
|
|
|
$
|
34,939
|
|
$
|
213,295
|
|
|
$
|
125,937
|
CpG 1018 adjuvant
product revenue, net
|
|
-
|
|
|
|
147,244
|
|
|
-
|
|
|
|
587,708
|
Other
revenue
|
|
4,510
|
|
|
|
2,309
|
|
|
18,989
|
|
|
|
9,038
|
Total
revenues
|
|
55,596
|
|
|
|
184,492
|
|
|
232,284
|
|
|
|
722,683
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HEPLISAV-B cost of
sales – product
|
|
8,689
|
|
|
|
12,391
|
|
|
50,167
|
|
|
|
40,131
|
CpG 1018 cost of sales
– product
|
|
-
|
|
|
|
65,097
|
|
|
-
|
|
|
|
222,022
|
Research and
development
|
|
14,119
|
|
|
|
12,854
|
|
|
54,886
|
|
|
|
46,600
|
Selling, general and
administrative
|
|
41,279
|
|
|
|
31,015
|
|
|
152,946
|
|
|
|
131,408
|
Gain on sale of
assets
|
|
-
|
|
|
|
-
|
|
|
(1,000)
|
|
|
|
(1,000)
|
Bad debt
expense
|
|
-
|
|
|
|
-
|
|
|
12,313
|
|
|
|
-
|
Total operating
expenses
|
|
64,087
|
|
|
|
121,357
|
|
|
269,312
|
|
|
|
439,161
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
|
(8,491)
|
|
|
|
63,135
|
|
(37,028)
|
|
|
283,522
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
9,556
|
|
|
|
4,324
|
|
|
31,993
|
|
|
|
7,912
|
Interest
expense
|
|
(1,692)
|
|
|
|
(1,684)
|
|
|
(6,757)
|
|
|
|
(6,732)
|
Sublease
income
|
|
1,993
|
|
|
|
2,025
|
|
|
7,577
|
|
|
|
7,685
|
Change in fair value of
warrant liability
|
|
-
|
|
|
|
-
|
|
|
-
|
|
|
|
1,801
|
Other
|
|
(370)
|
|
|
|
174
|
|
|
(152)
|
|
|
|
111
|
Net income (loss)
before income taxes
|
|
996
|
|
|
|
67,974
|
|
|
(4,367)
|
|
|
294,299
|
Provision for income
taxes
|
|
(777)
|
|
|
|
(241)
|
|
|
(2,022)
|
|
|
|
(1,143)
|
Net income
(loss)
|
$
|
219
|
|
|
$
|
67,733
|
|
$
|
(6,389)
|
|
|
$
|
293,156
|
Net income (loss)
per share attributable to common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
stockholders:
|
|
Basic
(*)
|
$
|
0.00
|
|
|
$
|
0.53
|
|
$
|
(0.05)
|
|
|
$
|
2.32
|
Diluted
(*)
|
$
|
0.00
|
|
|
$
|
0.45
|
|
$
|
(0.05)
|
|
|
$
|
1.97
|
Weighted-average
shares used in computing net income (loss) per share attributable
to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
129,381
|
|
|
|
127,589
|
|
|
128,733
|
|
|
|
126,398
|
Diluted
|
|
133,278
|
|
|
|
151,728
|
|
|
128,733
|
|
|
|
150,797
|
(*) GAAP net income per share (basic and diluted) was
less than $0.01 for the fourth quarter of
2023.
|
DYNAVAX TECHNOLOGIES
CORPORATION
|
SELECTED BALANCE
SHEET DATA
|
(In
thousands)
|
(Unaudited)
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
2023
|
|
2022
|
Assets
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
742,302
|
|
$
|
624,395
|
Inventories
|
|
|
53,290
|
|
|
59,446
|
Other current
assets
|
|
|
63,528
|
|
|
233,144
|
Total current
assets
|
|
|
859,120
|
|
|
916,985
|
Total non-current
assets
|
|
|
137,976
|
|
|
68,865
|
Total
assets
|
|
$
|
997,096
|
|
$
|
985,850
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Total current
liabilities
|
|
$
|
62,195
|
|
$
|
150,074
|
Total long-term
liabilities
|
|
|
312,829
|
|
|
254,763
|
Stockholders'
equity
|
|
|
622,072
|
|
|
581,013
|
Total liabilities
and stockholders' equity
|
|
$
|
997,096
|
|
$
|
985,850
|
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SOURCE Dynavax Technologies