- Q2 2022 total revenue of $256.5
million, up 386% from $52.8
million for Q2 2021
-
- HEPLISAV-B® vaccine net product
revenue of $32.7 million, up 139% from $13.7 million for Q2 2021
- CpG 1018® adjuvant net
product revenue of $222.6
million, up 471% from $39.0
million for Q2 2021
- On track for second consecutive year of
profitability
- Conference call today at 4:30 p.m.
ET/1:30 p.m. PT
EMERYVILLE, Calif., Aug. 4, 2022
/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
ending June 30, 2022.
"During the second quarter, we continued to successfully execute
on our key priorities and are on track for another profitable year
with record revenues for both HEPLISAV-B and CpG 1018 adjuvant,"
commented Ryan Spencer, Chief
Executive Officer of Dynavax. "We are well capitalized to continue
to invest in programs that drive revenue growth and deliver
progress across our clinical pipeline with a focus on high value
vaccine programs where our proven adjuvant may provide meaningful
advantages."
SECOND-QUARTER CORPORATE HIGHLIGHTS
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B
vaccine approved in the U.S. and EU that enables series completion
with only two doses in one month.
- HEPLISAV-B vaccine achieved net product revenue of $32.7 million for the second quarter of 2022, up
139% compared to $13.7 million for
the second quarter of 2021.
- Market share in the accounts targeted by the Dynavax field
sales team increased to approximately 39%, with total market share
increasing to approximately 32% in the second quarter of 2022, up
from approximately 30% and 19% respectively, in the second quarter
of 2021.
CpG 1018® Adjuvant Supply for COVID-19
Vaccines
Dynavax has established a global portfolio of CpG 1018
adjuvant commercial supply agreements (CSA) currently focused on
the development of COVID-19 vaccines across a variety of vaccine
platforms.
- CpG 1018 adjuvant revenue for the second quarter of 2022 was
$222.6 million, up 471% compared to
$39.0 million for the second quarter
of 2021.
- The Company now expects 2022 full-year CpG 1018 adjuvant
COVID-19 supply revenue to be between $550
million and $600 million,
based on committed orders, with an anticipated full-year gross
margin of approximately 60%.
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: Previously reported interim adult data from an
on-going Phase 1 clinical trial evaluating the Company's adjuvanted
Tdap vaccine candidate demonstrated it was well tolerated without
safety concerns with immunogenicity data supporting continued
advancement. The Company anticipates adolescent data from the same
trial in the fourth quarter of 2022.
- Shingles vaccine program: The Company recently completed
enrollment in the ongoing Phase 1 study evaluating the safety,
tolerability, and immunogenicity in adults compared to Shingrix,
the leading marketed shingles vaccine in the U.S. Topline data is
anticipated in the fourth quarter of 2022.
- Plague vaccine candidate: The Company anticipates that
in August the first participant will be dosed in a Phase 2 clinical
trial evaluating the immunogenicity, safety and tolerability of a
plague vaccine candidate utilizing CpG 1018 adjuvant. The clinical
trial is being conducted in collaboration with, and funded by, the
U.S. Department of Defense.
SECOND-QUARTER FINANCIAL HIGHLIGHTS
Total Revenues and Product Revenue, Net.
Total
revenues for the second quarter of 2022 were $256.5 million, compared to $52.8 million for the second quarter of 2021.
- U.S. HEPLISAV-B vaccine product revenue, net was $32.7 million for the second quarter of 2022,
compared to $13.7 million for the
second quarter of 2021. Additionally, approximately $0.9 million was reported in HEPLISAV-B net
product sales associated with sales to the Company's
commercialization partner in Germany, Bavarian Nordic.
- CpG 1018 adjuvant product revenue, net was $222.6 million in the second quarter of 2022
compared to $39.0 million in the
second quarter of 2021.
- Selected financial highlights from CpG 1018 adjuvant product
supply partnerships for COVID-19 vaccines and vaccine
candidates:
-
- The Company recorded approximately $68.0
million in CpG 1018 adjuvant product revenue under its CSA
with Valneva. Dynavax does not have any further supply
obligations under the CSA.
- The Company recorded approximately $51.0
million in CpG 1018 adjuvant product revenue under its CSA
with Biological E.
- The Company recorded approximately $91.3
million in CpG 1018 adjuvant product revenue under its CSA
with Clover.
- The Company recorded approximately $12.3
million in CpG 1018 adjuvant product revenue under its CSA
with Bio Farma. In May 2022, Dynavax and Bio Farma entered into
a CSA for the supply of CpG 1018 adjuvant to be used in
Bio Farma's subunit COVID-19 vaccine
candidate, currently in a Phase 3 immunogenicity and safety
study.
Cost of Sales - Product. Cost of sales - product for the
second quarter of 2022 increased to $83.4
million, compared to $14.8
million for the second quarter of 2021. The increase was
primarily due to manufacturing costs for increased volumes of CpG
1018 adjuvant sold to COVID-19 supply partners and increased
HEPLISAV-B vaccine sales volume.
Research and Development Expenses (R&D). R&D
expenses for the second quarter of 2022 increased to $9.7 million, compared to $7.2 million for the second quarter of 2021. The
increase was primarily driven by increased headcount-related
compensation and personnel costs, including non-cash stock-based
compensation, as well as investments in product candidates
utilizing CpG 1018 adjuvant and additional discovery efforts.
Selling, General, and Administrative Expenses (SG&A).
SG&A expenses for the second quarter of 2022 increased to
$36.2 million, compared to
$21.6 million for the second quarter
of 2021. The increase was primarily driven by compensation and
related personnel costs, including non-cash stock-based
compensation, primarily associated with increased headcount as the
Company expanded its field sales team to support HEPLISAV-B vaccine
commercialization in mid-2021.
Interest Expense. Interest expense was $1.7 million in the second quarter of 2022, a
decrease of $1.4 million from
$3.1 million in the second quarter of
2021, reflecting a decreased interest rate associated with the
Company's convertible senior notes due 2026.
Net Income. GAAP net income was $128.8 million, or $1.02 per share (basic) and $0.87 per share (diluted) in the second quarter
of 2022, compared to GAAP net income of $4.5
million, or $0.04 per share
(basic) and $0.02 per share (diluted)
in the second quarter of 2021.
Cash and Marketable Securities. Cash and marketable
securities were $518.2 million as of
June 30, 2022.
2022 Financial Guidance
Dynavax anticipates 2022
revenues, operating expenses, and other costs to be in the ranges
shown below, updated from the Company's previous financial guidance
provided on May 5, 2022:
- Full-year CpG 1018 adjuvant net product revenues of between
$550 million and $600 million, with an associated gross margin
anticipated to be approximately 60%
- Research and development expenses to be between approximately
$50-$60
million
- Selling, general and administrative expenses to be between
approximately $130-$140 million
- Interest expense of approximately $7
million
Conference Call and Webcast Information
Dynavax will
host a conference call and live audio webcast on Thursday, August 4, 2022, 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.
and the European Union 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 through global research
collaborations and partnerships. Current collaborations are focused
on adjuvanted vaccines for COVID-19, seasonal influenza, universal
influenza, plague, shingles and Tdap. 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, including statements regarding
financial guidance, 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 Quarterly Report on
Form 10-Q for the quarter ended June 30,
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, 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.
Contacts:
Nicole Arndt,
Investor Relations and Corporate Communications
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
DYNAVAX TECHNOLOGIES
CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands,
except per share amounts)
(Unaudited)
|
|
|
|
Three Months
Ended
|
|
|
Six Month
Ended
|
|
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues,
net
|
|
$
|
255,320
|
|
|
$
|
52,677
|
|
|
$
|
367,647
|
|
|
$
|
135,562
|
|
Other
revenue
|
|
|
1,144
|
|
|
|
90
|
|
|
|
2,809
|
|
|
|
540
|
|
Total
revenues
|
|
|
256,464
|
|
|
|
52,767
|
|
|
|
370,456
|
|
|
|
136,202
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales –
product
|
|
|
83,369
|
|
|
|
14,845
|
|
|
|
123,331
|
|
|
|
39,470
|
|
Research and
development
|
|
|
9,689
|
|
|
|
7,167
|
|
|
|
20,784
|
|
|
|
14,925
|
|
Selling, general and
administrative
|
|
|
36,179
|
|
|
|
21,583
|
|
|
|
68,351
|
|
|
|
44,006
|
|
Gain on sale of
assets
|
|
|
(1,000)
|
|
|
|
-
|
|
|
|
(1,000)
|
|
|
|
-
|
|
Total operating
expenses
|
|
|
128,237
|
|
|
|
43,595
|
|
|
|
211,466
|
|
|
|
98,401
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
|
128,227
|
|
|
|
9,172
|
|
|
|
158,990
|
|
|
|
37,701
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
765
|
|
|
|
48
|
|
|
|
1,026
|
|
|
|
95
|
|
Interest
expense
|
|
|
(1,683)
|
|
|
|
(3,109)
|
|
|
|
(3,363)
|
|
|
|
(7,821)
|
|
Sublease
income
|
|
|
2,025
|
|
|
|
1,670
|
|
|
|
3,634
|
|
|
|
3,692
|
|
Loss on debt
extinguishment
|
|
|
-
|
|
|
|
(5,232)
|
|
|
|
-
|
|
|
|
(5,232)
|
|
Change in fair value of
warrant liability
|
|
|
-
|
|
|
|
2,097
|
|
|
|
1,801
|
|
|
|
(23,455)
|
|
Other
|
|
|
40
|
|
|
|
(173)
|
|
|
|
145
|
|
|
|
384
|
|
Net income before
provision for income taxes
|
|
|
129,374
|
|
|
|
4,473
|
|
|
|
162,233
|
|
|
|
5,364
|
|
Provision for income
taxes
|
|
|
(619)
|
|
|
|
-
|
|
|
|
(619)
|
|
|
|
-
|
|
Net
income
|
|
$
|
128,755
|
|
|
$
|
4,473
|
|
|
$
|
161,614
|
|
|
$
|
5,364
|
|
Net income per share
attributable to common stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
1.02
|
|
|
$
|
0.04
|
|
|
$
|
1.29
|
|
|
$
|
0.04
|
|
Diluted
|
|
$
|
0.87
|
|
|
$
|
0.02
|
|
|
$
|
1.08
|
|
|
$
|
0.04
|
|
Weighted-average
shares used in computing net income per share attributable to
common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
126,347
|
|
|
|
114,629
|
|
|
|
125,456
|
|
|
|
113,339
|
|
Diluted
|
|
|
149,905
|
|
|
|
118,830
|
|
|
|
149,821
|
|
|
|
114,978
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DYNAVAX TECHNOLOGIES
CORPORATION
SELECTED BALANCE
SHEET DATA
(In
thousands)
(Unaudited)
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2022
|
|
|
2021
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash, cash equivalents,
and marketable securities
|
|
$
|
518,169
|
|
|
$
|
545,950
|
|
Inventories,
net
|
|
|
73,979
|
|
|
|
61,335
|
|
Property and equipment,
net
|
|
|
36,286
|
|
|
|
35,020
|
|
Operating lease
right-of-use assets
|
|
|
25,785
|
|
|
|
25,964
|
|
Goodwill
|
|
|
1,958
|
|
|
|
2,125
|
|
Other
assets
|
|
|
366,822
|
|
|
|
368,852
|
|
Total
assets
|
|
$
|
1,022,999
|
|
|
$
|
1,039,246
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
$
|
345,198
|
|
|
$
|
556,402
|
|
Total long-term
liabilities
|
|
|
255,002
|
|
|
|
260,470
|
|
Stockholders'
equity
|
|
|
422,799
|
|
|
|
222,374
|
|
Total liabilities
and stockholders' equity
|
|
$
|
1,022,999
|
|
|
$
|
1,039,246
|
|
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SOURCE Dynavax Technologies