Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, today reported financial results for the fourth
quarter and full year 2019.
“Vaccines offer an unmatched value to the
healthcare system and Dynavax continues to make tremendous progress
on its transformation into a leading vaccine company. Our first
product, HEPLISAV-B, provides adults higher and faster protection
from hepatitis B in just two doses compared to previously available
vaccines,” commented Ryan Spencer, Chief Executive Officer of
Dynavax. “We are excited by the response from our customers and our
continued success in growing market share, which reinforces our
belief that HEPLISAV-B has the potential to become the standard of
care for adult hepatitis B vaccination in the U.S.”
Mr. Spencer added, “Our focus in 2020 is driving
annual revenue growth of HEPLISAV-B, generating data to support a
unique dosing regimen for patients on hemodialysis, and supporting
policy initiatives aimed at protecting more adults through adoption
of a two-dose regimen, all of which position HEPLISAV-B for
substantial long-term growth.”
2019 Results and Recent Business
Highlights
HEPLISAV-B® [Hepatitis B Vaccine
(Recombinant), Adjuvanted]
- Full year 2019 net product revenue
of $34.6 million compared to $6.8 million for
2018.
- Market share in accounts targeted
by the field sales team increased to 21% in the fourth quarter 2019
from 18% in the third quarter 2019.
- The Company filed the cumulative
analysis (comprising both required interim analyses) of its
post-marketing study assessing the rates of occurrence of acute
myocardial infarction in persons receiving HEPLISAV-B compared with
Engerix-B with the U.S. Food and Drug Administration. The event
rates were similar between the two treatment arms.
- Announced partnership with
Albertsons Companies’ 1,700 pharmacies nationwide, to provide
HEPLISAV-B to people living with diabetes.
Corporate Updates
- Established research collaboration with the University of
Queensland and the Coalition for Epidemic Preparedness to develop a
coronavirus (COVID-19) vaccine.
- Appointed Ryan Spencer Chief Executive Officer and to the Board
of Directors.
- Appointed David Novack President and Chief Operating
Officer.
2020 Milestones
- HEPLISAV-B® net product revenue
expected to increase to $55-$62 million for the full year 2020
- Release interim data from ongoing
study of HEPLISAV-B in patients on hemodialysis in Q1 2020 and
final immunogenicity data in the second half of 2020
- Complete Phase 1-enabling animal
studies and toxicology for improved pertussis vaccine with CpG
1018
- Enter multiple strategic
relationships focused on initial research in a variety of vaccine
candidates to establish CpG 1018 as a leading adjuvant
- Complete safety follow-up for
HEPLISAV-B post-marketing studies in Q4 2020
Financial Results
Product Revenue, Net.
HEPLISAV-B was launched in the first quarter of 2018.
Net product revenue for the fourth quarter 2019 was $10.6
million, compared to $3.9 million for the fourth quarter 2018.
Full year net product revenue for 2019 was $34.6 million
compared to $6.8 million for the full year 2018. Product
revenue from sales is recorded at the net sales price, which
includes estimates of product returns, chargebacks, discounts and
other fees.
Cost of Sales - Product.
Cost of sales - product for the fourth
quarter 2019 was $2.4 million, compared to $1.6 million for the
fourth quarter 2018. Full year 2019 cost of sales - product
was $10.2 million, compared to $10.9 million for the full year
2018.
R&D Expenses. Research and
development (R&D) expenses for the fourth quarter of 2019 were
$12.3 million, compared to $22.9 million for the fourth quarter of
2018. Full year 2019 R&D expenses were $62.3 million,
compared to $75.0 million for the full year 2018. The
decrease in R&D expenses is due to the winding down of oncology
research and development activity resulting from the Company’s
strategic organizational restructuring to focus on its vaccine
business that was implemented in May 2019. R&D expenses
in the fourth quarter of 2019 included approximately $3 million in
external expenses related to oncology programs. These
expenses are expected to continue to decrease over the next three
quarters as activities are completed, with total additional
external expenses over that period anticipated to be approximately
$6 million.
SG&A Expenses. Selling,
general and administrative (SG&A) expenses for the fourth
quarter of 2019 were $20.3 million, compared to $16.4 million for
the fourth quarter of 2018. Full year 2019 SG&A expenses
were $75.0 million, compared to $64.8 million for the full year
2018. The increase for both the three and 12 months ended
December 31, 2019 compared to 2018, was due primarily to increases
in sales and marketing activities, payments for completion of
certain milestones in the HEPLISAV-B post-marketing study and
higher facility costs due to an increase in facility related
overhead allocation to SG&A functions following the May
restructuring and increased lease expense which is being recouped
through a sublease to a third party and recorded as part of other
income (expense).
Net Loss. Net loss allocable to
common stockholders for the fourth quarter of 2019 was $36.8
million, or $0.44 per basic and diluted share, compared to a net
loss of $40.0 million, or $0.64 per basic and diluted share, for
the fourth quarter of 2018. Full year, net loss allocable to
common stockholders, was $155.9 million, or $2.16 per basic and
diluted share, compared to a net loss of $158.9 million, or $2.55
per basic and diluted share for the full year 2018.
Cash Position. Cash, cash
equivalents and marketable securities totaled $151.1 million at
December 31, 2019.
Conference Call and Webcast
InformationDynavax 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
800-458-4121 (domestic) or 720-543-0206 (international) and refer
to conference ID 1989638. A replay of the webcast will be
available for 30 days following the live event.
About Hepatitis BHepatitis 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-BHEPLISAV-B is
an adult hepatitis B vaccine that combines hepatitis B surface
antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9
agonist to enhance the immune response. Dynavax has worldwide
commercial rights to HEPLISAV-B.
For more information about HEPLISAV-B, visit
http://heplisavb.com/.
About DynavaxDynavax is a
commercial stage biopharmaceutical company developing and
commercializing novel vaccines. The Company launched its first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], in February 2018, following U.S. FDA approval for
prevention of infection caused by all known subtypes of hepatitis B
virus in adults age 18 years and older. 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., revenue
projections for HEPLISAV-B, long-term growth of HEPLISAV-B, the
timing of enrollment in and completion of clinical studies, the
results of clinical studies and what the results will demonstrate
or support, developing an improved pertussis vaccine and other
vaccines, entering into strategic relationships, establishing CpG
1018 as a leading adjuvant, and revenue and expense expectations
for 2020. 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 the vaccine market and/or
the adult hepatitis B market may not grow as expected, the risk
that HEPLISAV-B may not provide the anticipated benefits and may
not become the standard of care adult hepatitis B vaccine in the
U.S., the risk that our growth initiatives may not be successful,
the risk that our 2020 revenue and/or expenses may not meet our
expectations, 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 and the adverse effects of the recent
coronavirus pandemic on our ability to access customers and on
customer decision making, adoption and implementation; as well as
other risks detailed in the "Risk Factors" section of our Quarterly
Report on Form 10-Q for the fiscal quarter ended September 30,
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
Relationsnarndt@dynavax.com510-665-7264
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
CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except per share
amounts)(Unaudited)
|
Three Months Ended |
|
|
Year Ended |
|
|
December 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenues, net |
$ |
10,558 |
|
|
$ |
3,932 |
|
|
$ |
34,644 |
|
|
$ |
6,812 |
|
Collaboration revenue |
|
- |
|
|
|
1,386 |
|
|
|
143 |
|
|
|
1,386 |
|
Other
revenue |
|
12 |
|
|
|
- |
|
|
|
432 |
|
|
|
- |
|
Total revenues |
|
10,570 |
|
|
|
5,318 |
|
|
|
35,219 |
|
|
|
8,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales – product |
|
2,407 |
|
|
|
1,625 |
|
|
|
10,172 |
|
|
|
10,934 |
|
Cost of
sales - amortization of intangible assets |
|
2,323 |
|
|
|
2,324 |
|
|
|
9,217 |
|
|
|
10,862 |
|
Research
and development |
|
12,269 |
|
|
|
22,892 |
|
|
|
62,331 |
|
|
|
74,951 |
|
Selling,
general and administrative |
|
20,318 |
|
|
|
16,438 |
|
|
|
74,986 |
|
|
|
64,770 |
|
Restructuring |
|
642 |
|
|
|
- |
|
|
|
13,356 |
|
|
|
- |
|
Total operating expenses |
|
37,959 |
|
|
|
43,279 |
|
|
|
170,062 |
|
|
|
161,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
(27,389 |
) |
|
|
(37,961 |
) |
|
|
(134,843 |
) |
|
|
(153,319 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
766 |
|
|
|
888 |
|
|
|
3,370 |
|
|
|
3,828 |
|
Interest
expense |
|
(4,866 |
) |
|
|
(2,751 |
) |
|
|
(16,977 |
) |
|
|
(9,338 |
) |
Sublease
income |
|
1,728 |
|
|
|
- |
|
|
|
2,619 |
|
|
|
- |
|
Change
in fair value of warrant liability |
|
(7,266 |
) |
|
|
- |
|
|
|
(7,500 |
) |
|
|
- |
|
Other
income (expense), net |
|
271 |
|
|
|
(145 |
) |
|
|
731 |
|
|
|
(70 |
) |
Net loss |
|
(36,756 |
) |
|
|
(39,969 |
) |
|
|
(152,600 |
) |
|
|
(158,899 |
) |
Preferred stock deemed dividend |
|
- |
|
|
|
- |
|
|
|
(3,267 |
) |
|
|
- |
|
Net loss allocable to common stockholders |
$ |
(36,756 |
) |
|
$ |
(39,969 |
) |
|
$ |
(155,867 |
) |
|
$ |
(158,899 |
) |
Net loss per share allocable to common stockholders – basic
and diluted |
$ |
(0.44 |
) |
|
$ |
(0.64 |
) |
|
$ |
(2.16 |
) |
|
$ |
(2.55 |
) |
Weighted average
shares used to compute basic and diluted net loss per share
allocable to common stockholders |
|
83,868 |
|
|
|
62,694 |
|
|
|
72,024 |
|
|
|
62,362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA(In
thousands)(Unaudited)
|
December 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
151,055 |
|
|
$ |
145,536 |
|
Inventories, net |
|
41,332 |
|
|
|
19,022 |
|
Property and equipment, net |
|
32,022 |
|
|
|
17,064 |
|
Intangible assets, net |
|
2,500 |
|
|
|
11,717 |
|
Goodwill |
|
2,081 |
|
|
|
2,144 |
|
Other assets |
|
50,078 |
|
|
|
15,401 |
|
Total
assets |
$ |
279,068 |
|
|
$ |
210,884 |
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Total current liabilities |
$ |
53,047 |
|
|
$ |
38,033 |
|
Total long-term liabilities |
|
217,731 |
|
|
|
109,786 |
|
Stockholders’ equity |
|
8,290 |
|
|
|
63,065 |
|
Total liabilities and
stockholders’ equity |
$ |
279,068 |
|
|
$ |
210,884 |
|
|
|
|
|
|
|
|
|
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