- First quarter 2022 total revenue of $114.0 million, up 37% from $83.3 million for Q1 2021
-
- HEPLISAV-B® vaccine net product revenue of
$20.8 million, up 151% from
$8.3 million for Q1 2021
- CpG 1018® adjuvant net product revenue of $91.5 million, up 23% from $74.6 million for Q1 2021
- Guidance reiterated for 2022 CpG 1018 revenue, operating
expenses, and other costs
- On track for a second consecutive year of
profitability
- Conference call today at 4:30 p.m.
ET/1:30 p.m. PT
EMERYVILLE, Calif., May 5, 2022
/PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq:
DVAX), a commercial-stage biopharmaceutical company developing and
commercializing innovative vaccines, today reported financial
results and provided business updates for the three months ending
March 31, 2022.
Ryan Spencer, Chief Executive
Officer of Dynavax, commented: "Following a year of record revenue
for both HEPLISAV-B vaccine and CpG 1018 adjuvant, 2022 is off to a
great start and has the potential to be another pivotal year.
In the first quarter, HEPLISAV-B grew 21% compared to the
fourth quarter, exceeding the overall hepatitis B market growth of
14%. The first quarter also marked another quarter of significant
revenue for CpG 1018 adjuvant supply for COVID-19 vaccines as we
continue to demonstrate strong execution across our portfolio of
commercial supply agreements. Looking ahead, we are on track to
achieve our second consecutive profitable year with continued
revenue growth fueled by HEPLISAV-B and our CpG 1018 adjuvant
supply business. This year we also expect additional clinical data
readouts from both of our Phase 1 pipeline programs for Tdap and
shingles."
FIRST-QUARTER CORPORATE HIGHLIGHTS
HEPLISAV-B® Vaccine [Hepatitis B Vaccine (Recombinant),
Adjuvanted]
HEPLISAV-B vaccine is the first and only U.S. FDA-approved
adult hepatitis B vaccine that enables series completion with only
two doses in one month.
- HEPLISAV-B vaccine achieved net product revenue of $20.8 million for the first quarter of 2022, up
151% compared to $8.3 million for the
first quarter of 2021.
- Market share in the accounts targeted by the Dynavax field
sales team was approximately 33%, with a total market share of
approximately 26% in the first quarter of 2022, up from
approximately 27% and 14%, respectively, in the first quarter of
2021.
- The CDC's Advisory Committee on Immunization Practices (ACIP)
recommendation for hepatitis B vaccination in adults has been
published (link), advising that all adults aged 19-59 should be
vaccinated against hepatitis B. Dynavax believes this will enable a
significantly expanded total market opportunity of up to
$800 million in the U.S. by 2027,
with HEPLISAV-B well positioned to secure a majority market share
over time.
CpG 1018® Adjuvant Supply for COVID-19
Vaccines
Dynavax has established a global portfolio of CpG 1018
adjuvant commercial supply agreements currently focused on the
development of COVID-19 vaccines across a variety of vaccine
platforms.
- CpG 1018 adjuvant revenue for the first quarter of 2022 was
$91.5 million, up 23% compared to
$74.6 million for the first quarter
of 2021.
- The Company continues to expect 2022 full-year CpG 1018
adjuvant COVID-19 supply revenue to be at least $550 million, based on committed adjuvant orders,
with full-year gross margin anticipated to be approximately 50%.
Revenue and margins are expected to fluctuate quarter to quarter
based on customer mix and timing of product delivery.
- CpG 1018 adjuvant supply partner selected recent regulatory
updates:
-
- Biological E (Bio E) has received Emergency Use Authorization
(EUA) from the Drugs Controller General of India (DCGI) for its subunit COVID-19 vaccine
candidate, CORBEVAX™ utilizing CpG 1018 adjuvant, for adults
(December 2021), for adolescents aged
12 to less than 18 years of age (February
2022) and for use in children ages 5-12 (April 2022).
- Clover Biopharmaceuticals has reported it is in the process of
submitting conditional regulatory approval applications for its
protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum)
utilizing CpG 1018 adjuvant. Clover anticipates that its
submissions are to be completed in mid-2022 for the China NMPA and
by the third quarter of 2022 for the WHO and EMA.
- Medigen Vaccine Biologics Corporation received EUA for
MVC-COV1901, its COVID-19 vaccine candidate utilizing CpG 1018
adjuvant, from the Taiwan Food and Drug Administration in 2021 and
from Paraguay's National
Directorate of Health Surveillance (DINAVISA) in February 2022.
- Valneva SE recently announced that the Medicines and Healthcare
products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional
Marketing Authorization (CMA) for its COVID-19 vaccine candidate,
VLA2001 utilizing CpG 1018 adjuvant. Valneva also reported that it
now expects a decision from CHMP on its recommendation for
potential conditional approval by the European Medicines Agency
(EMA) in the second quarter of 2022.
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.
- Tdap vaccine program: Interim adult data from the
ongoing Phase 1 study evaluating a new Tdap vaccine candidate
utilizing CpG 1018 adjuvant demonstrated it was safe and well
tolerated with immunogenicity data supporting continued
advancement. Adolescent data from the same trial is expected in the
second half of 2022.
- Shingles vaccine program: Topline data from an ongoing
Phase 1 study evaluating the safety, tolerability, and
immunogenicity in adults compared to Shingrix, the leading marketed
shingles vaccine in the U.S., is anticipated by the end of
2022.
- Plague vaccine Phase 2 study: In collaboration with, and
funded by, the U.S. Department of Defense, the Company plans to
initiate a Phase 2 clinical trial in the second half of 2022.
FIRST-QUARTER FINANCIAL HIGHLIGHTS
Total Revenues and Product Revenue, Net.
Total
revenues for the first quarter of 2022 were $114.0 million, compared to $83.3 million for the first quarter of 2021.
- HEPLISAV-B vaccine product revenue, net was $20.8 million for the first quarter of 2022,
compared to $8.3 million for the
first quarter of 2021.
- CpG 1018 adjuvant product revenue, net was $91.5 million in the first quarter of 2022
compared to $74.6 million in the
first quarter of 2021.
Cost of Sales - Product. Cost of sales - product for the
first quarter of 2022 increased to $40.0
million, compared to $24.6
million for the first 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 first quarter of 2022 increased to $11.1 million, compared to $7.8 million for the first quarter of 2021. The
increase was primarily driven by higher compensation and personnel
costs, including non-cash stock-based compensation, associated with
higher headcount and higher external costs as the Company continued
to invest in its product candidates with CpG 1018 adjuvant through
pre-clinical and clinical collaborations and additional discovery
efforts.
Selling, General, and Administrative Expenses (SG&A).
SG&A expenses for the first quarter of 2022 increased to
$32.2 million, compared to
$22.4 million for the first 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 first quarter of 2022, a
decrease of $3.0 million from
$4.7 million in the first quarter of
2021, reflecting a decreased interest rate associated with the
Company's convertible senior notes due 2026.
Other income (expense). Other income (expense) includes
the change in fair value of warrant liability which is a non-cash
adjustment to fair value each reporting period. The change in fair
value of warrant liability for the first quarter of 2022 resulted
in a gain of $1.8 million, compared
to a loss of $25.6 million in the
first quarter of 2021 due to the final mark-to-market adjustment
from January 1, 2022, through the
expiration date of the warrants on February
12, 2022. There were no warrants outstanding as of
March 31, 2022.
Net Income. GAAP net income was $32.9 million, or $0.26 per share (basic) and 0.22 per share
(diluted) in the first quarter of 2022, compared to GAAP net income
of $0.9 million, or $0.01 per share (basic and diluted) in the first
quarter of 2021.
2022 Financial Guidance
Dynavax anticipates 2022
revenues, operating expenses, and other costs to be in the ranges
shown below, unchanged from the Company's previous financial
guidance provided on February 28,
2022:
- Full-year CpG 1018 adjuvant net product revenues of at least
$550 million, with an associated
gross margin of approximately 50%
- Research and development expenses to be between approximately
$55 - $70
million
- Selling, general and administrative expenses to be between
approximately $120 - $140 million
- Interest expense of approximately $7
million
Conference Call and Webcast Information
Dynavax will
hold a conference call today 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 http://investors.dynavax.com/events-presentations.
Alternatively, participants may dial (866) 420-4066 or (409)
217-8237 and refer to conference ID 4282730. A replay of the
webcast will be available for 30 days following the live event.
Please see Important Safety Information below.
For more information about HEPLISAV-B vaccine, visit
http://heplisavb.com.
About Hepatitis B
Hepatitis B is a viral disease of
the liver that can become chronic and lead to cirrhosis, liver
cancer, and death. The hepatitis B virus is 50 to 100 times more
infectious than HIV, I and transmission are on the rise.
There is no cure for hepatitis B, but effective vaccination can
prevent the disease.
In adults, hepatitis B is spread through contact with infected
blood and through unprotected sex with an infected person. The U.S.
Centers for Disease Control's (CDC) Advisory Committee on
Immunization Practices (ACIP) recommends that adults aged 19–59
years and adults aged ≥60 years with risk factors for hepatitis B
should receive HepB vaccines, and that adults aged ≥60 years
without known risk factors for hepatitis B may receive HepB
vaccines.iii Because people with diabetes are
particularly vulnerable to infection, the CDC recommends
vaccination for adults aged 19 to 59 with diabetes as soon as
possible after their diagnosis, and for people aged 60 and older
with diabetes at their physician's discretion. iii
Approximately 26 million U.S. adults have diabetes, and 1.5 million
new cases of diabetes are diagnosed each year. iv
About HEPLISAV-B Vaccine [Hepatitis B Vaccine (Recombinant),
Adjuvanted]
HEPLISAV-B vaccine is an adult hepatitis B
vaccine that combines hepatitis B surface antigen with Dynavax's
proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to
enhance the immune response. Dynavax wholly owns HEPLISAV-B.
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 CpG 1018 Adjuvant
Dynavax developed CpG 1018
adjuvant to provide an increased vaccine immune response with an
improved tolerability profile, which has been demonstrated in
HEPLISAV-B vaccine and multiple COVID-19 vaccines that have
received Emergency Use Authorization outside of the U.S. CpG 1018
adjuvant provides a well-developed technology and a significant
safety database, potentially accelerating the development and
large-scale manufacturing of novel or improved vaccines.
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 age 18 years 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, establishing CpG 1018 adjuvant as a leading
adjuvant, 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, or the timing of our collaborators to seek
conditional or emergency use authorization of COVID-19 vaccines
containing CpG 1018 adjuvant. 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 conducted by us or our collaborators, risks that
our collaborators will not obtain regulatory approval of their
vaccine candidates, 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, when and
whether 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 March 31, 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
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
i CDC.
https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
ii
CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.
iii CDC.
https://www.cdc.gov/hepatitis/hbv/vaccadults.htm
iv CDC.
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
DYNAVAX TECHNOLOGIES
CORPORATION
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except per share amounts)
|
(Unaudited)
|
|
|
Three Months
Ended
|
|
March
31,
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
|
|
Product revenues,
net
|
$
|
112,327
|
|
$
|
82,885
|
Other
revenue
|
|
1,665
|
|
|
450
|
Total
revenues
|
|
113,992
|
|
|
83,335
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Cost of sales –
product
|
|
39,962
|
|
|
24,625
|
Research and
development
|
|
11,095
|
|
|
7,758
|
Selling, general and
administrative
|
|
32,172
|
|
|
22,423
|
Total operating
expenses
|
|
83,229
|
|
|
54,806
|
|
|
|
|
|
|
Income from
operations
|
|
30,763
|
|
|
28,529
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
Interest
income
|
|
261
|
|
|
47
|
Interest
expense
|
|
(1,680)
|
|
|
(4,712)
|
Sublease
income
|
|
1,609
|
|
|
2,022
|
Change in fair value of
warrant liability
|
|
1,801
|
|
|
(25,552)
|
Other
|
|
105
|
|
|
557
|
Net
income
|
$
|
32,859
|
|
|
891
|
Net income per share
attributable to common stockholders
|
|
|
|
|
|
Basic
|
$
|
0.26
|
|
$
|
0.01
|
Diluted
|
$
|
0.22
|
|
$
|
0.01
|
Weighted-average
shares used in computing net income per
share attributable to common stockholders:
|
|
|
|
|
|
Basic
|
|
124,555
|
|
|
112,035
|
Diluted
|
|
149,425
|
|
|
113,469
|
DYNAVAX TECHNOLOGIES
CORPORATION
|
SELECTED BALANCE
SHEET DATA
|
(In
thousands)
|
(Unaudited)
|
|
|
March
31,
|
|
December
31,
|
|
2022
|
|
2021
|
Assets
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
$
|
503,216
|
|
$
|
545,950
|
Inventories,
net
|
|
79,038
|
|
|
61,335
|
Property and equipment,
net
|
|
36,407
|
|
|
35,020
|
Operating lease
right-of-use assets
|
|
26,310
|
|
|
25,964
|
Goodwill
|
|
2,082
|
|
|
2,125
|
Other
assets
|
|
361,922
|
|
|
368,852
|
Total
assets
|
$
|
1,008,975
|
|
$
|
1,039,246
|
|
|
|
|
|
|
Liabilities and stockholders'
equity
|
|
|
|
|
|
Total current
liabilities
|
$
|
466,203
|
|
$
|
556,402
|
Total long-term
liabilities
|
|
255,288
|
|
|
260,470
|
Stockholders'
equity
|
|
287,484
|
|
|
222,374
|
Total liabilities
and stockholders' equity
|
$
|
1,008,975
|
|
$
|
1,039,246
|
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SOURCE Dynavax Technologies