EMERYVILLE, Calif.,
Aug. 4, 2021 /PRNewswire/
-- Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, today reported financial results for the second
quarter of 2021.
"Our successful execution in the second quarter of 2021
continued to build on the progress made in 2020. With the combined
strength of opportunities from HEPLISAV-B and CpG 1018, we believe
2021 will be a transformational year for Dynavax," commented
Ryan Spencer, Chief Executive
Officer of Dynavax. "HEPLISAV-B achieved its highest quarterly
revenue at $13.7 million and
continues to increase market share, which reinforces our belief
that it will become the standard of care in the U.S. for adult
hepatitis B vaccinations."
Mr. Spencer continued, "Dynavax is also making progress on
numerous collaborations for its proven CpG 1018 vaccine adjuvant
across multiple indications, including COVID-19, pertussis, and
universal flu. Our COVID-19 collaborations have advanced
significantly in recent months with the execution of commercial
supply agreements with Biological E and Clover Biopharmaceuticals,
in addition to the two previously executed agreements with Valneva
and Medigen. Multiple partners have reported that they currently
intend to apply for emergency or conditional authorization for
their COVID-19 vaccines in the second half of 2021. Importantly,
these collaborations are generating meaningful revenue for Dynavax,
with second quarter CpG 1018 revenue of $39
million. We continue to be excited about each of our
partners' clinical programs and believe that the emerging portfolio
of product opportunities with CpG 1018 adjuvant has the potential
to continue generating meaningful future value for Dynavax."
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted]
- Net product revenue for HEPLISAV-B was $13.7 million during the second quarter 2021,
representing the highest quarterly HEPLISAV-B net sales to
date, compared to $2.4 million for the second
quarter 2020. This increase was primarily driven by continued
success in the field
targeted accounts and ongoing progress in
national accounts.
- Market share in accounts targeted by the field sales team
increased to 30%, up from 21% in the second quarter of 2020.
- Dynavax and Bavarian Nordic
entered into a commercialization
agreement for the marketing and distribution
of HEPLISAV B in Germany.
CpG 1018® (Advanced Vaccine
Adjuvant)
- Net product revenue for CpG 1018 adjuvant during the second
quarter 2021 was $39.0 million.
- Dynavax and Biological E (Bio E) entered into a commercial
supply agreement for the use of CpG 1018 adjuvant in the
commercial production of Bio E's subunit COVID-19 vaccine
candidate, CORBEVAX™. Upon completion of their Phase 2/3 and
subsequently emergency use authorization (EUA) India's Union
Ministry of Health has reserved 300 million doses of
CORBEVAX™.
- Dynavax and Clover Biopharmaceuticals entered into
a commercial supply agreement for the use of CpG 1018 adjuvant
in the commercial production of Clover's COVID-19 vaccine
candidate, SCB-2019 (CpG 1018/Alum). In parallel, Clover
announced an advanced purchase agreement with GAVI to supply up to
414 million doses of SCB-2019 (CpG 1018/Alum) through 2022 for the
COVAX Facility.
- The Coalition for Epidemic Preparedness Innovations (CEPI)
expanded its agreement with Dynavax to provide funding to
manufacture CpG 1018 for CEPI's COVID-19 vaccine grantees,
increasing total funding under the loan agreement from $99.0 million to $176.4
million to support Dynavax's manufacturing costs.
- Medigen Vaccine Biologics Corporation received EUA
from the Taiwan Food and Drug Administration and received
approval for inclusion in Taiwan's
COVID-19 vaccination immunization program for MVC-COV1901, its
COVID-19 vaccine adjuvanted with CpG 1018.
- Valneva SE reported positive initial results for Part A of
the Phase 1/2 clinical trial of its COVID-19 vaccine candidate,
VLA2001 adjuvanted with CpG 1018. Based on the positive results
Valneva initiated a pivotal Phase 3 clinical trial, which is now
fully enrolled. Valneva is also participating in a UK
government-funded clinical trial looking at various COVID-19
'booster' vaccines.
Convertible Debt Offering
- In May 2020, we issued
$225.5 million in aggregate principal
amount of 2.50% convertible senior notes due 2026. As of
June 30, 2021, the aggregate
principal amount of our Convertible Notes was $225.5 million, excluding debt discount of
$5.5 million.
- A portion of the net proceeds from the offering were used to
pay off an existing $190.2 million
term loan in full, including the termination payment. In connection
with the offering, we also entered into capped call transactions
with certain financial institutions that are expected generally to
reduce the potential dilution to common stock in certain
circumstances, upon conversion of the notes.
- This debt refinancing is expected to reduce interest expense by
approximately $12.1 million on an
annualized basis.
Upcoming Milestones
- CDC Advisory Committee on Immunization Practices expected to
vote on a universal hepatitis b recommendation for all previously
unvaccinated adults in October.
- Multiple data readouts from our CpG 1018 COVID-19 collaboration
partners with potential for emergency or conditional use
authorization by the end of 2021.
- Data from Tdap-1018 in the ongoing Phase 1 clinical trial, for
an improved tetanus, diphtheria, and acellular pertussis booster
vaccine candidate adjuvanted with CpG 1018 expected in first
quarter 2022.
Financial Results
Total Revenue. Total revenues for the second quarter of
2021 were $52.8 million, including
$52.7 million of net product revenue,
an increase from total revenue for the second quarter of 2020 of
$2.7 million.
Product Revenue, Net. HEPLISAV-B product revenue,
net was $13.7 million in the second
quarter of 2021 compared to $2.4
million in the same period in 2020. CpG 1018 product
revenue, net was $39.0 million in the
second quarter of 2021 and there was no revenue in the same period
in 2020. As CpG 1018 revenues are generally recorded upon shipment
to a customer, there may be fluctuations in revenues between
quarters as shipments often consist of large-sized batches.
Cost of Sales - Product. Cost of sales - product for the
second quarter 2021 increased to $14.8
million, compared to $1.0
million for the second quarter of 2020. The increase was
primarily due to manufacturing costs for increased volumes of CpG
1018 and HEPLISAV-B sold to customers.
Research and Development Expenses (R&D). R&D
expenses for the second quarter of 2021 increased to $7.2 million, compared to $5.9 million for the second quarter of 2020. The
increase is primarily associated with higher headcount and outside
services to support vaccine clinical and development
activities.
Selling, General and Administrative Expenses (SG&A).
SG&A expenses for the second quarter of 2021 increased to
$21.6 million, compared to
$19.0 million for the second quarter
of 2020. This increase is primarily driven by compensation and
related personnel costs, including non-cash stock-based
compensation, associated with higher headcount.
Income (loss) from Operations and Net Income (loss).
Income from operations for the second quarter of 2021 was
$9.2 million compared to a loss from
operations of $23.3 million in the
second quarter of 2020. Net income for the second quarter of 2021
was $4.5 million compared to a net
loss of $51.6 million for the second
quarter of 2020.
Earnings per share. Basic and diluted net income per
share were $0.04 and $0.02, respectively, for the second quarter of
2021, compared to basic and diluted net loss per share of
($0.53) and ($0.53), respectively, in the second quarter of
2020.
Cash Position. Cash, cash equivalents and marketable
securities totaled $345.8 million at
June 30, 2021.
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 www.dynavax.com. Alternatively, participants may
dial (866) 420-4066 or (409) 217-8237 and refer to conference ID
9970706. 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, 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 is 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 (CDC) recommends vaccination for those
at high risk for infection due to their jobs, lifestyle, living
situations and travel to certain areas.ii Because people
with diabetes are particularly vulnerable to infection, the CDC
recommends vaccination for adults age 19 to 59 with diabetes as
soon as possible after their diagnosis, and for people age 60 and
older with diabetes at their physician's discretion.iii
Approximately 20 million U.S. adults have diabetes, and 1.5 million
new cases of diabetes are diagnosed each year.iv
About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B
vaccine that combines hepatitis B surface antigen with Dynavax's
proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance
the immune response. Dynavax has worldwide commercial rights to
HEPLISAV-B.
Important U.S. Product Information
HEPLISAV-B is
indicated for prevention of infection caused by all known subtypes
of hepatitis B virus in adults age 18 years and older.
Safety and effectiveness of HEPLISAV-B have not been established
in adults on hemodialysis.
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 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%).
Important EU/EEA Product Information
HEPLISAV B is
indicated for active immunisation against hepatitis B virus
infection (HBV) caused by all known subtypes of hepatitis B virus
in adults 18 years of age and older.
The use of HEPLISAV B should be in accordance with official
recommendations.
It can be expected that hepatitis D will also be prevented by
immunization with HEPLISAV B as hepatitis D (caused by the delta
agent) does not occur in the absence of hepatitis B infection.
For full EU/EEA. Prescribing Information for HEPLISAV-B, click
here.
Important EU/EEA Safety information
Do not receive
HEPLISAV B if you have had a sudden life-threatening, allergic
reaction after receiving HEPLISAV B in the past, or if you are
allergic to any of components of this vaccine, including yeast.
Signs of an allergic reaction may include itchy skin, rash,
shortness of breath and swelling of the face or tongue.
Appropriate medical treatment and supervision should be readily
available in case of rare anaphylactic reactions following the
administration of the vaccine.
The administration of HEPLISAV B should be postponed in subjects
suffering from acute severe febrile illness.
Immunocompromised persons may have a diminished immune response to
HEPLISAV B.
Because of the long incubation period of hepatitis B, it is
possible for unrecognised HBV infection to be present at the time
of immunisation. HEPLISAV B may not prevent HBV infection in such
cases.
There are very limited data on the immune response to HEPLISAV B in
individuals who did not mount a protective immune response to
another hepatitis B vaccine.
As a precautionary measure, it is preferable to avoid the use of
HEPLISAV B during pregnancy. Vaccination during pregnancy should
only be performed if the risk-benefit ratio at the individual level
outweighs possible risks for the fetus.
The most common patient-reported side effects reported within 7
days of vaccination were pain, swelling or redness at the injection
site, feeling tired, headache, muscle aches, feeling unwell and
fever.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used
in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an
increased vaccine immune response, which has been demonstrated in
HEPLISAV-B. CpG 1018 adjuvant provides a well- developed technology
and a significant safety database, potentially accelerating the
development and large-scale manufacturing of a COVID-19
vaccine.
About Dynavax
Dynavax is a commercial stage
biopharmaceutical company developing and commercializing novel
vaccines. The Company's first commercial product, HEPLISAV-B®
[Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the
U.S. and the European Union for prevention of infection caused by
all known subtypes of hepatitis B virus in adults age 18 years and
older. Dynavax is also advancing CpG 1018 adjuvant as a premier
vaccine adjuvant through research collaborations and partnerships.
Current collaborations are focused on adjuvanted vaccines for
COVID-19, pertussis and universal influenza. For more information,
visit www.dynavax.com and follow the company on LinkedIn.
Forward-Looking Statements This press release contains
"forward-looking" statements, including statements regarding the
potential for HEPLISAV-B to become the standard of care adult
hepatitis B vaccine in the U.S., establishing CpG 1018 as a leading
adjuvant, the development and potential approval of vaccines
containing CpG 1018 and potential future sales of CpG 1018 or
HEPLISAV-B, the timing of initiation and completion of clinical
studies and the publication of results, the timing of our
collaborators seeking emergency use authorization of COVID-19
vaccines containing CpG 1018 adjuvant, our ability to scale
manufacturing capacity, the expected demand for our products, our
efforts to develop an improved pertussis vaccine and a seasonal flu
vaccine, our collaboration partners' efforts to develop a vaccine
for COVID-19 and a universal flu vaccine, entering into strategic
relationships and expected results of such relationships, the
potential for CpG 1018 to accelerate development and large scale
manufacturing of a COVID-19 vaccine and sales potential under
certain agreements. 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 HEPLISAV-B may
not become the standard of care adult hepatitis B vaccine in the
U.S., risks related to whether and when prescribers and other key
decision-makers at potential purchasing entities will make the
decision to switch to HEPLISAV-B, and the timing and quantity of
actual purchases, risks related to the timing and result of the
ACIP vote on a universal hepatitis b
recommendation, risks related to the timing of completion and
results of current clinical studies, risks that our collaborators
will not get approval of their vaccine candidates, risks related to
the development and pre-clinical and clinical testing of vaccines
containing CpG 1018, and whether use of CpG 1018 will prove to be
beneficial in these vaccines, risks related to whether, when and
the quantity of CpG 1018 actually purchased by vaccine companies,
risks related to the use of contract manufacturers to supply CpG
1018 and financial commitments made to them, as well as other risks
detailed in the "Risk Factors" section of our Annual Report on Form
10-K for the fiscal year ended December 31,
2020, as well as discussions of potential risks,
uncertainties and other important factors in our other filings with
the U.S. Securities and Exchange Commission. 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,
Senior Manager, 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/diabetes/pubs/pdf/hepb_vaccination.pdf.
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
|
|
|
Six Months
Ended
|
|
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues,
net
|
|
$
|
52,677
|
|
|
$
|
2,405
|
|
|
$
|
135,562
|
|
|
$
|
12,919
|
|
Other
revenue
|
|
|
90
|
|
|
|
263
|
|
|
|
540
|
|
|
|
668
|
|
Total
revenues
|
|
|
52,767
|
|
|
|
2,668
|
|
|
|
136,102
|
|
|
|
13,587
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales –
product
|
|
|
14,845
|
|
|
|
967
|
|
|
|
39,470
|
|
|
|
3,321
|
|
Cost of sales -
amortization of intangible assets
|
|
|
-
|
|
|
|
202
|
|
|
|
-
|
|
|
|
2,500
|
|
Research and
development
|
|
|
7,167
|
|
|
|
5,884
|
|
|
|
14,925
|
|
|
|
10,537
|
|
Selling, general and
administrative
|
|
|
21,583
|
|
|
|
18,954
|
|
|
|
44,006
|
|
|
|
39,880
|
|
Total operating
expenses
|
|
|
43,595
|
|
|
|
26,007
|
|
|
|
98,401
|
|
|
|
56,238
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
9,172
|
|
|
|
(23,339)
|
|
|
|
37,701
|
|
|
|
(76,825)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
48
|
|
|
|
331
|
|
|
|
95
|
|
|
|
921
|
|
Interest
expense
|
|
|
(3,109)
|
|
|
|
(4,732)
|
|
|
|
(7,821)
|
|
|
|
(9,463)
|
|
Sublease
income
|
|
|
1,670
|
|
|
|
1,927
|
|
|
|
3,692
|
|
|
|
3,853
|
|
Loss on debt
extinguishment
|
|
|
(5,232)
|
|
|
|
-
|
|
|
|
(5,232)
|
|
|
|
-
|
|
Change in fair value
of warrant liability
|
|
|
2,097
|
|
|
|
(25,655)
|
|
|
|
(23,455)
|
|
|
|
(17,045)
|
|
Other
|
|
|
(173)
|
|
|
|
(111)
|
|
|
|
384
|
|
|
|
211
|
|
Net income
(loss)
|
|
$
|
4,473
|
|
|
$
|
(51,579)
|
|
|
$
|
5,364
|
|
|
$
|
(64,174)
|
|
Net income (loss)
per share – basic
|
|
$
|
0.04
|
|
|
$
|
(0.53)
|
|
|
$
|
0.04
|
|
|
$
|
(0.70)
|
|
Weighted average
shares used to compute basic net income (loss) per
share
|
|
|
114,629
|
|
|
|
97,339
|
|
|
|
113,339
|
|
|
|
91,408
|
|
Net income (loss)
per share – diluted
|
|
$
|
0.02
|
|
|
$
|
(0.53)
|
|
|
$
|
0.04
|
|
|
$
|
(0.70)
|
|
Weighted average
shares used to compute diluted net income (loss) per
share
|
|
|
118,830
|
|
|
|
97,339
|
|
|
|
114,978
|
|
|
|
91,408
|
|
DYNAVAX
TECHNOLOGIES CORPORATION
|
SELECTED BALANCE
SHEET DATA
|
(In
thousands)
|
(Unaudited)
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2021
|
|
|
2020
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
345,804
|
|
|
$
|
165,036
|
|
Inventories,
net
|
|
|
86,451
|
|
|
|
63,689
|
|
Property and
equipment, net
|
|
|
32,547
|
|
|
|
30,567
|
|
Operating lease
right-of-use assets
|
|
|
25,164
|
|
|
|
26,583
|
|
Goodwill
|
|
|
2,225
|
|
|
|
2,297
|
|
Other
assets
|
|
|
155,718
|
|
|
|
65,100
|
|
Total
assets
|
|
$
|
647,909
|
|
|
$
|
353,272
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
$
|
204,642
|
|
|
$
|
77,411
|
|
Total long-term
liabilities
|
|
|
359,887
|
|
|
|
217,168
|
|
Stockholders'
equity
|
|
|
83,380
|
|
|
|
58,693
|
|
Total liabilities
and stockholders' equity
|
|
$
|
647,909
|
|
|
$
|
353,272
|
|
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SOURCE Dynavax Technologies