Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated
biopharmaceutical company focused on discovering, developing and
commercializing novel vaccines and immuno-oncology therapeutics,
today reported financial results for the first quarter ended March
31, 2019.
“HEPLISAV-B net product revenue was $5.6 million for the first
quarter of this year, which was in line with our expectations,”
said Eddie Gray, chief executive officer of Dynavax. “As the only
two-dose hepatitis B vaccine, we are focused on making HEPLISAV-B
the standard of care hepatitis B adult vaccine in the U.S. On the
immuno-oncology development front, we will have three SD-101 data
presentations at ASCO.”
First Quarter and Recent Business
Highlights
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted]
- First quarter 2019 sales of $5.6 million compared to $3.9
million in the fourth quarter 2018
- The company has achieved sales into 3 of the 4 top national
retail pharmacy chains, and contracting efforts are underway to
secure additional pharmacy partners
- More than 1,454 individual customers have purchased HEPLISAV-B
since launch
- Only 4% of doses sold to date were to customers who have not
reordered after at least 45 days
- 15 of the top 20 Integrated Delivery Networks (IDNs) have made
HEPLISAV-B available to order
- 557 of the targeted 1,419 accounts have made HEPLISAV-B
available to order, representing 50% of the targeted adult
hepatitis B market
- 164 of the top 300 targeted customers have ordered
HEPLISAV-B
- In May, the company announced the enrollment of the first
patient in an open-label, single-arm study of HEPLISAV-B in adults
with end-stage renal disease who are initiating or undergoing
hemodialysis. The study is designed to evaluate immunogenicity and
safety.
Immuno-oncology
SD-101
Three Dynavax abstracts have been accepted for presentation at
the ASCO Annual Meeting 2019 in June.
- Abstract #6039, “Phase 1b/2, open label, multicenter study of
intratumoral SD-101 in combination with pembrolizumab in anti-PD-1
treatment naive patients with recurrent or metastatic head and neck
squamous cell carcinoma (HNSCC)”
- Abstract #9534, “Phase 1b/2, open label, multicenter, study of
the combination of SD-101 and pembrolizumab in patients with
advanced melanoma who are naïve to anti-PD-1 therapy”
- Abstract #9555, “Phase 1b/2, open label, multicenter, study of
the combination of SD-101 and pembrolizumab in patients with
advanced/metastatic melanoma resistant to anti-PD-1/PD-L1
therapy”
DV281
Dynavax presented phase 1b data on inhaled DV281 TLR9 agonist at
the 2019 AACR Annual Meeting. Key highlights from the clinical data
presentation include:
- In this safety study, two doses of DV281 monotherapy followed
by combination with nivolumab was well tolerated
- Inhalation of DV281 leads to dose-dependent target engagement
as measured by induction of IFN-regulated genes at all evaluated
dose levels
- DV281 plus nivolumab demonstrates early signs of antitumor
activity in heavily pretreated patients
Financial Results
Product Revenue, Net. Dynavax’s first
commercial product, HEPLISAV-B, was launched in the first quarter
of 2018. Net product revenue for the first quarter of 2019 was $5.6
million, compared to $0.2 million for the first quarter of 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 first quarter of 2019 was $1.8
million, compared to $0.2 million for the first quarter of 2018.
Included in cost of sales - product, are fill,
finish and overhead costs for HEPLISAV-B incurred after U.S. Food
and Drug Administration (FDA) approval. A higher percentage
of HEPLISAV-B inventory sold in 2019 used components manufactured
after FDA approval compared to 2018, when most of the expense
associated with product sold was expensed to research and
development prior to approval. The company expects its HEPLISAV-B
cost of sales to increase in future periods as it produces and then
sells inventory that reflects the full cost of manufacturing the
product.
R&D Expenses. Research and development
expenses for the first quarter of 2019 were $21.2 million, compared
to $19.0 million for the first quarter of 2018. The increase
reflects additional personnel and clinical trial expense for
ongoing development of SD-101 and DV281.
SG&A. Selling, general and administrative
expenses for the first quarter of 2019 were $18.3 million, compared
to $16.9 million for the first quarter of 2018. The increase was
due primarily to additional personnel in support of HEPLISAV-B
commercial activities.
Net Loss. Net loss for the first quarter of
2019 was $39.7 million, or $0.62 per basic and diluted share,
compared to a net loss of $39.0 million, or $0.63 per basic and
diluted share, for the first quarter of 2018.
Cash Position. Cash, cash equivalents and
marketable securities totaled $183.2 million at March 31, 2019,
compared to $145.5 million at December 31, 2018. In March 2019,
Dynavax exercised its option to draw down $75 million of
non-dilutive capital under its existing term loan agreement with
CRG Servicing LLC.
Conference Call and Webcast Information
Dynavax will hold a conference call today at 4:30 p.m. ET/1:30
p.m. PT. To access the call, participants may dial (855) 327-6837
(domestic) or (631) 891-4304 (international) and refer to
conference ID 10006654. The live call will be webcast and can be
accessed in the "Investors and Media" section of the company's
website at www.dynavax.com. 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. In 2015, new
cases of acute hepatitis B increased by more than 20 percent
nationally.ii 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 CDC
recommends vaccination for those at high risk for infection due to
their jobs, lifestyle, living situations and travel to certain
areas.iii 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.iv Approximately 20 million U.S. adults have diabetes,
and 1.5 million new cases of diabetes are diagnosed each year.v
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 SD-101 SD-101, the Company's lead
clinical candidate, is a proprietary, second-generation, Toll-like
receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax
is evaluating this intratumoral TLR9 agonist in several clinical
studies to assess its safety and activity, including a Phase 1b/2
study in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1
therapy, in patients with advanced melanoma and in patients with
head and neck squamous cell cancer, in a clinical collaboration
with Merck. Dynavax maintains all commercial rights to SD-101.
About DV281 DV281 is Dynavax's proprietary
investigational TLR9 agonist designed specifically for focused
delivery to primary lung tumors and lung metastases. DV281 is
similar in biological activity and mechanism of action to Dynavax's
Phase 2 immunotherapy candidate, SD-101, but has been optimized for
administration as an inhaled therapy. Both SD-101 and DV281
activate plasmacytoid dendritic cells which then stimulate T cells
specific for antigens released from dying tumor cells. TLR9
agonists such as DV281 and SD-101 have been shown to stimulate
potent Type 1 interferon induction along with maturation of
dendritic cells to effective antigen-presenting cells; both
activities are important for the induction of effective anti-tumor
immunity.
About DynavaxDynavax is a fully-integrated
biopharmaceutical company focused on leveraging the power of the
body's innate and adaptive immune responses through toll-like
receptor (TLR) stimulation. Dynavax discovers and
develops novel vaccines and immuno-oncology therapeutics. 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. Dynavax's lead immunotherapy product,
SD-101, is an investigational cancer immunotherapeutic currently
being evaluated in Phase 1/2 studies and its second cancer
immunotherapeutic, DV281, is in Phase 1 development. For more
information, visit www.dynavax.com.
Forward-Looking Statements This press
release contains "forward-looking" statements, including statements
regarding the commercialization of HEPLISAV-B. Actual results may
differ materially from those set forth in this press release due to
the risks and uncertainties inherent in our business, including
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 timing of fully-enrolling and completing the HEPLISAV-B study
of adults with end-stage renal disease and the results of the
study, 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, 2018 and in our Quarterly Report on Form 10-Q for the
quarter ended March 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.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
i |
CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm. |
ii |
CDC.
https://www.cdc.gov/hepatitis/statistics/2015surveillance/index.htm#tabs-5-8.
Fig 3.2 |
iii |
CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm. |
iv |
CDC.
https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf. |
v |
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 |
|
March 31, |
|
2019 |
|
2018 |
Revenues: |
|
|
|
|
|
Product revenues, net |
$ |
5,627 |
|
|
$ |
165 |
|
Collaboration revenue |
|
146 |
|
|
|
- |
|
Total
revenues |
|
5,773 |
|
|
|
165 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Cost of sales – product |
|
1,800 |
|
|
|
205 |
|
Cost of sales - amortization
of intangible assets |
|
2,273 |
|
|
|
2,417 |
|
Research and development |
|
21,206 |
|
|
|
18,966 |
|
Selling, general and
administrative |
|
18,348 |
|
|
|
16,891 |
|
Total operating
expenses |
|
43,627 |
|
|
|
38,479 |
|
|
|
|
|
|
|
Loss from operations |
|
(37,854 |
) |
|
|
(38,314 |
) |
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
Interest income |
|
735 |
|
|
|
740 |
|
Interest expense |
|
(2,734 |
) |
|
|
(1,161 |
) |
Other income (expense),
net |
|
181 |
|
|
|
(223 |
) |
Net loss |
$ |
(39,672 |
) |
|
$ |
(38,958 |
) |
Basic and diluted net
loss per share |
$ |
(0.62 |
) |
|
$ |
(0.63 |
) |
Weighted average
shares used to compute basic and diluted net loss per
share |
|
63,778 |
|
|
|
61,744 |
|
|
|
|
|
|
|
|
|
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA(In
thousands)(Unaudited)
|
March 31, |
|
December 31, |
|
2019 |
|
2018 |
Assets |
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
$ |
183,216 |
|
$ |
145,536 |
Inventories, net |
|
27,569 |
|
|
19,022 |
Property
and equipment, net |
|
25,305 |
|
|
17,064 |
Intangible assets, net |
|
9,445 |
|
|
11,717 |
Operating lease right-of-use assets |
|
33,505 |
|
|
- |
Goodwill |
|
2,102 |
|
|
2,144 |
Other
assets |
|
15,458 |
|
|
15,401 |
Total assets |
$ |
296,600 |
|
$ |
210,884 |
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
Total
current liabilities |
$ |
42,251 |
|
$ |
38,033 |
Total
long-term liabilities |
|
211,190 |
|
|
109,786 |
Stockholders’ equity |
|
43,159 |
|
|
63,065 |
Total liabilities and stockholders’ equity |
$ |
296,600 |
|
$ |
210,884 |
Contact:
Heather Rowe
Vice President, Investor Relations & Corporate Communications
hrowe@dynavax.com
510-665-7269
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