EMERYVILLE, Calif.,
Nov. 5, 2020 /PRNewswire/
-- Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, today reported financial results for the third
quarter of 2020.
"The current global pandemic highlights the need for continued
development of new and improved vaccines," commented Ryan Spencer, Chief Executive Officer of
Dynavax. "Our team at Dynavax is leveraging its expertise in
vaccine development and commercialization to build a leading
vaccine company around our FDA-approved adult hepatitis B vaccine,
HEPLISAV-B, which we believe has the potential to become the
standard of care in the U.S., as well as our pipeline of
opportunities enabled by our vaccine adjuvant CpG 1018."
Mr. Spencer added, "The overall vaccine market continues to
rebound from the significant declines seen in the first and second
quarters, with the adult hepatitis B vaccine market recovering to
approximately 75% of the same period last year. HEPLISAV-B sales
have come back even stronger based on success in key national
accounts and continued growth in field targeted account market
share, resulting in our highest quarterly revenue to date. In
addition, we have entered into numerous collaborations to develop
adjuvanted vaccines across multiple indications, including
COVID-19, TdaP, and universal flu. This portfolio of CpG 1018
opportunities is driving the next leg of growth beyond HEPLISAV-B,
as initially seen with our commercial supply agreement with
Valneva, where we have the potential for 2021 CpG 1018 revenue
between approximately $130 and
$230 million."
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted]
- Net product revenue for HEPLISAV-B during the third quarter
2020 was $11.6 million, up
from $10.2 million for the third quarter of 2019, despite
the ongoing reduction in vaccine utilization due to COVID-19.
- Market share in accounts targeted by the field sales team
increased to approximately 23%, up from approximately 21% in the
previous quarter.
- Successful conversion of a top 5 national retail chain to
HEPLISAV-B, resulting in stocking over 2,000 store locations in the
third quarter.
CpG 1018 (proprietary toll-like receptor 9 (TLR9)
agonist adjuvant)
- In September 2020, Dynavax and
Valneva SE entered into a commercial supply agreement to provide
Valneva with CpG 1018 to produce 60 to 100 million doses of vaccine
in 2021. Valneva has the option to purchase CpG 1018 to produce up
to an additional 90 million doses through 2024. Under our
commercial supply agreement with Valneva, Dynavax has the potential
for 2021 CpG 1018 revenue between approximately $130 and $230
million, with a total revenue potential over $400 million through 2024, contingent on the
continued success of the program.
- Phase 1 data from Medicago and Clover Biopharmaceuticals are
expected to be released by mid-November and year-end 2020,
respectively.
- Based on the positive Phase 1 data to date, Clover
Biopharmaceuticals intends to develop two adjuvanted COVID-19
vaccine programs to fully utilize their available antigen
production capacity and anticipates initiating a pivotal clinical
trial with CpG 1018 to address global demand.
- Multiple ongoing global, collaborations are advancing the
development of adjuvanted vaccine candidates using Dynavax's CpG
1018. Dynavax expects to continue to broaden its portfolio of
vaccine product opportunities through additional business
arrangements. A summary of current CpG 1018 collaborations is
provided below.
Indication
|
Collaborator
|
Status
|
COVID-19
|
Clover
Biopharmaceuticals
|
Phase 1
|
Medicago
|
Phase 1
|
Medigen Vaccine
Biologics
|
Phase 1
|
Valneva
|
Preclinical
|
TdaP
|
Serum Institute of
India
|
Preclinical
|
Universal
Influenza
|
Mount
Sinai
|
Preclinical
|
Additional Corporate Updates
- Appointed Julie Eastland,
Brent MacGregor, and Peter Paradiso, Ph.D. to Board of Directors
- Communicated Michael Ostrach's
plan to retire as Chief Financial Officer in 2021
- Amended term loan agreement with CRG to modify the net sales
threshold requirement to include sales of CpG 1018 and remove the
annual net sales threshold requirement for the twelve-month period
beginning July 1, 2020 and ending on
June 30, 2021
2020 Milestones
- Final immunogenicity data from the ongoing study of HEPLISAV-B
in patients on hemodialysis anticipated in the fourth quarter with
publication planned in the first half of 2021
- Completion of safety follow-up period for HEPLISAV-B
post-marketing studies in the fourth quarter with the final report
expected in Q2 2021
- Completion of Phase 1-enabling animal studies and toxicology
for an improved TdaP vaccine with CpG 1018 is planned for the
fourth quarter
Financial Results
Product Revenue, Net. Total product revenue, net for
the third quarter 2020 was $13.3
million. HEPLISAV-B product revenue, net increased to
$11.6 million in the third quarter of
2020 compared to $10.2 million in the
same period in 2019. For the nine months ended September 30, 2020, the increase in HEPLISAV-B
product revenue, net in the first and third quarters was offset by
lower sales volume in the second quarter due to lower adult vaccine
utilization caused by the COVID-19 global pandemic. Utilization of
adult vaccines improved during the third quarter as health care
providers gradually expanded their services and distributors
replenished inventory. Sales during the third quarter also include
an initial stocking order from a large retail chain and the effect
of seasonal Department of Defense purchases. CpG 1018 product
revenue, net was $1.7 million in the
third quarter of 2020 compared to $0.0
million in the same period in 2019.
Cost of Sales - Product. Cost of sales - product
for the third quarter 2020 increased to $4.0
million, compared to $3.8
million for the third quarter of 2019, primarily due to
higher unit costs for HEPLISAV-B as we produce and then sell
inventory that reflects the full cost of manufacturing. For the
three months ended September 30,
2020, cost of sales-product included $0.8 million of costs to produce CpG 1018 for our
collaboration partners. The Company anticipates cost of
sales-product to increase substantially in 2021 due to increased
manufacturing of CpG 1018 under the supply agreement with
Valneva.
Research and Development Expenses. Research and
development (R&D) expenses for the third quarter of 2020
decreased to $8.5 million, compared
to $12.7 million for the third
quarter of 2019 as personnel costs, facilities overhead cost
allocations and non-cash stock-based compensation decreased due to
lower R&D headcount because of our restructuring in
May 2019 and the winding down of our
immuno-oncology programs, offset by an increase an additional CpG
1018 development costs at our third-party manufacturing facility to
support increased CpG 1018 demand from our collaboration partners
for use in their development and/or commercialization of COVID-19
vaccines.
SG&A Expenses. Selling, general and
administrative (SG&A) expenses for the third quarter of 2020
increased to $21.5 million, compared
to $18.5 million for the third
quarter of 2019 primarily due to a $2.5
million payment during the third quarter of 2020 in
connection with the sale of our immuno-oncology compound,
SD-101.
Loss from Operations and Net Income Loss. Loss from
operations for the third quarter of 2020 decreased to $13.8 million from $30.6
million in the third quarter of 2019. Net income for
the third quarter of 2020 was $4.4
million compared to a net loss of $36.7 million for the third quarter of 2019,
primarily due to a gain of $21.2
million in the fair value of our warrant liability. Basic
net income per share was $0.04 and
diluted net loss per share was $0.15
for the third quarter of 2020, compared to $0.49 per basic and diluted net loss per share in
the third quarter of 2019.
Cash Position. Cash, cash equivalents and marketable
securities totaled $177.2 million at
September 30, 2020.
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
1475431. 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.
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all
known subtypes of hepatitis B virus in adults age 18 years and
older.
Important 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%).
For full Prescribing Information for HEPLISAV-B, click here.
About CpG 1018
CpG 1018 is the adjuvant used in
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an
adult hepatitis B vaccine approved by the U.S. Food and Drug
Administration (FDA). Dynavax developed CpG 1018 to provide an
increased vaccine immune response, which has been demonstrated in
HEPLISAV-B. CpG 1018 provides a well- developed technology and a
significant safety database, potentially accelerating the
development and large-scale manufacturing of a COVID-19 vaccine.
Upon completion of on-going scale up activities, the existing
equipment capacity for CpG 1018 will be 600 million to 1.2 billion
adjuvant doses annually, depending on final dose selected.
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. 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 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 of vaccines containing CpG 1018 and
potential future sales of CpG 1018, the timing of completion of
pre-clinical and clinical studies and the publication of results,
our ability to scale manufacturing capacity, the expected demand
for our products developing an improved pertussis vaccine, a
vaccine for COVID-19, and a universal flu vaccine, entering into
strategic relationships and expected results of such relationships,
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 of completion and
results of current clinical studies of HEPLISAV-B, 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,
and 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, 2019, 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-r
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,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues,
net
|
|
$
|
13,276
|
|
|
$
|
10,158
|
|
|
$
|
26,195
|
|
|
$
|
24,086
|
|
Other
revenue
|
|
|
138
|
|
|
|
417
|
|
|
|
806
|
|
|
|
563
|
|
Total
revenues
|
|
|
13,414
|
|
|
|
10,575
|
|
|
|
27,001
|
|
|
|
24,649
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales -
product
|
|
|
4,031
|
|
|
|
3,824
|
|
|
|
7,352
|
|
|
|
7,765
|
|
Cost of sales -
amortization of intangible assets
|
|
|
-
|
|
|
|
2,324
|
|
|
|
2,500
|
|
|
|
6,894
|
|
Research and
development
|
|
|
8,521
|
|
|
|
12,660
|
|
|
|
19,058
|
|
|
|
50,062
|
|
Selling, general and
administrative
|
|
|
21,538
|
|
|
|
18,459
|
|
|
|
61,418
|
|
|
|
54,668
|
|
Gain on sale of
assets
|
|
|
(6,851)
|
|
|
|
|
|
|
|
(6,851)
|
|
|
|
|
|
Restructuring
|
|
|
-
|
|
|
|
3,937
|
|
|
|
-
|
|
|
|
12,714
|
|
Total operating
expenses
|
|
|
27,239
|
|
|
|
41,204
|
|
|
|
83,477
|
|
|
|
132,103
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(13,825)
|
|
|
|
(30,629)
|
|
|
|
(54,476)
|
|
|
|
(107,454)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
269
|
|
|
|
890
|
|
|
|
1,190
|
|
|
|
2,604
|
|
Interest
expense
|
|
|
(4,794)
|
|
|
|
(4,779)
|
|
|
|
(14,257)
|
|
|
|
(12,111)
|
|
Sublease
income
|
|
|
1,926
|
|
|
|
891
|
|
|
|
5,779
|
|
|
|
891
|
|
Change in fair value
of warrant liability
|
|
|
21,245
|
|
|
|
-
|
|
|
|
4,200
|
|
|
|
-
|
|
Other
|
|
|
(420)
|
|
|
|
168
|
|
|
|
(209)
|
|
|
|
226
|
|
Net income
(loss)
|
|
$
|
4,401
|
|
|
$
|
(33,459)
|
|
|
$
|
(59,773)
|
|
|
$
|
(115,884)
|
|
Preferred stock
deemed dividend
|
|
|
|
|
|
|
(3,267)
|
|
|
|
-
|
|
|
|
(3,267)
|
|
Net income (loss)
allocable to common stockholders
|
|
$
|
4,401
|
|
|
$
|
(36,726)
|
|
|
$
|
(59,773)
|
|
|
$
|
(119,111)
|
|
Basic net income
(loss) per share allocable to common stockholders
|
|
$
|
0.04
|
|
|
$
|
(0.49)
|
|
|
$
|
(0.61)
|
|
|
$
|
(1.75)
|
|
Weighted average
shares used to compute basic and diluted net income (loss) per
share allocable to common stockholders
|
|
|
109,816
|
|
|
|
75,106
|
|
|
|
97,589
|
|
|
|
68,032
|
|
Diluted net loss
per share allocable to common stockholders
|
|
$
|
(0.15)
|
|
|
$
|
(0.49)
|
|
|
$
|
(0.65)
|
|
|
$
|
(1.75)
|
|
Weighted average
shares used to compute diluted net loss
per share allocable
to common stockholders
|
|
|
111,973
|
|
|
|
75,106
|
|
|
|
98,577
|
|
|
|
68,032
|
|
DYNAVAX
TECHNOLOGIES CORPORATION
|
SELECTED BALANCE
SHEET DATA
|
(In
thousands)
|
(Unaudited)
|
|
|
|
September
30,
|
|
|
December
31,
|
|
|
|
2020
|
|
|
2019
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
177,161
|
|
|
$
|
151,055
|
|
Inventories,
net
|
|
|
59,033
|
|
|
|
41,332
|
|
Property and
equipment, net
|
|
|
30,379
|
|
|
|
32,022
|
|
Intangible assets,
net
|
|
|
-
|
|
|
|
2,500
|
|
Operating lease
right-of-use assets
|
|
|
27,353
|
|
|
|
30,252
|
|
Goodwill
|
|
|
2,196
|
|
|
|
2,081
|
|
Other
assets
|
|
|
57,273
|
|
|
|
19,826
|
|
Total
assets
|
|
$
|
353,395
|
|
|
$
|
279,068
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
$
|
66,625
|
|
|
$
|
53,047
|
|
Total long-term
liabilities
|
|
|
217,486
|
|
|
|
217,731
|
|
Stockholders'
equity
|
|
|
69,284
|
|
|
|
8,290
|
|
Total liabilities
and stockholders' equity
|
|
$
|
353,395
|
|
|
$
|
279,068
|
|
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SOURCE Dynavax Technologies