HEPLISAV-B® Launch Progressing as Planned with
Key Customer Successes
Dynavax Technologies Corporation (NASDAQ:DVAX) today reported
financial results for the second quarter ended June 30, 2018. The
net loss for the quarter was $39.4 million,
or $0.63 per share, compared to $20.3 million,
or $0.41 per share, for the quarter ended June 30, 2017.
Cash, cash equivalents and marketable securities totaled $216.0
million at June 30, 2018.
Recent HighlightsHEPLISAV-B® [Hepatitis
B Vaccine (Recombinant), Adjuvanted]
- 100% of Medicare-insured lives, 94% of commercially-insured
lives, and 73% of lives under state Medicaid plans are covered
- 219 of our largest targeted customers have received P&T
committee approval, of whom 91 have progressed to purchase and 24
have implemented the use of HEPLISAV-B throughout their system
- Another 198 target customers have sub-committee or P&T
committee review scheduled
- Q2 sales of $1.3 million compared to $0.2 million in Q1
Immuno-oncology
- Encouraging SD-101 Phase 1b/2 advanced melanoma data in
combination with KEYTRUDA® in patients naïve to anti PD-1 therapy
for 2 mg dose selected for Phase 3:-- Overall response rate (ORR)
of 70%-- 80% ORR in patients with low
PD-L1-- 6-month progression free survival (PFS) rate of
76%
- AEs related to SD-101 treatment were transient, mild to
moderate flu-like symptoms
- End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) scheduled
- Three abstracts accepted for presentation at the European
Society for Medical Oncology (ESMO) 2018 Annual Meeting, October
19-23, 2018
“The launch is progressing as planned and I continue to expect
HEPLISAV-B will become the standard of care for vaccination of
adults against hepatitis B. During my field visits, I have
personally witnessed the strength of the product profile and label
in motivating customers to switch vaccines,” said Eddie Gray, chief
executive officer of Dynavax. “Our efforts to date are beginning to
pay off with increasing sales, which we expect will accelerate
during Q4 and into 2019, when we expect HEPLISAV-B to be cash
generative before year end. In addition, we continue to
advance our SD-101 clinical program which has shown encouraging
results so far in both melanoma and head and neck carcinoma
patients. We look forward to updating these data later this
year.”
Financial ResultsCash, cash equivalents and
marketable securities of $216.0 million at end of the second
quarter, with $75 million available from the February 2018 term
loan agreement
Net product revenue was $1.3 million for the quarter ended June
30, 2018, which consists of sales of HEPLISAV-B in the U.S. 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 was $5.2 million for the quarter ended
June 30, 2018 and consists of certain fill, finish and fixed
overhead costs for HEPLISAV-B incurred after FDA approval and costs
relating to excess capacity at our Dusseldorf manufacturing
facility associated with resuming operations after receiving FDA
approval of HEPLISAV-B and pre-filled syringes.
Cost of sales, amortization of intangible assets was $2.3
million for the quarter ended June 30, 2018 and consists of
amortization of the intangible asset recorded as a result of
milestone and sublicense payments relating to HEPLISAV-B.
Research and development expenses for the quarter ended June 30,
2018 and 2017, were $16.3 million and $14.8 million, respectively.
The increase in 2018 reflects increased compensation and related
personnel costs related to the ongoing development of SD-101, DV281
and earlier stage oncology programs. Additionally, in the current
quarter, manufacturing related costs incurred by our Dusseldorf
facility that were previously included in research and development
expense are now accounted for as excess capacity in our cost of
sales, product.
Selling, general and administrative expenses for the quarter
ended June 30, 2018 and 2017, were $15.7 million and $5.6 million,
respectively. The increase is primarily due to an overall increase
in HEPLISAV-B sales, marketing and commercial activities, including
full-deployment of a contract sales force, post-marketing studies
and consultants for commercial development services.
Conference Call and Webcast InformationDynavax
will hold a conference call today at 4:30pm ET/1:30pm PT. To access
the call, participants must dial (800) 239-9838 in the U.S. or
(323) 794-2551 internationally, and use the conference ID 2303066.
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.
A replay of the conference call will be available for two weeks
and can be accessed by dialing (844) 512-2921 in the U.S. or (412)
317-6671 internationally. The conference ID for the replay will be
2303066.
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-101SD-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 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 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’s first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], was approved by the United States Food and Drug
Administration in November 2017 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, conduct of clinical
trials of SD-101, including results from the Phase 1b/2 trial,
planned optimal dosage for the Phase 3 trial, and potential value
of SD-101 across multiple tumor types. 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
we are able to continue to build the commercial infrastructure
required to increase adoption of HEPLISAV-B; whether payers will
provide timely reimbursement for HEPLISAV-B; whether prescribers
and other key decision-makers will switch to HEPLISAV-B; whether we
can timely provide adequate clinical supplies; initiation,
enrollment and completion of clinical trials of SD-101; the results
of clinical trials and the impact of those results on the
initiation or continuation of subsequent trials and issues arising
in the regulatory process; the ability to successfully develop and
commercialize SD-101; and whether or not Dynavax and parties with
whom we are collaborating may reach any future agreement on further
studies or a more extensive collaboration beyond the clinical
trials contemplated under the existing agreements, 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, 2017 and in
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018,
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.
Contact: David BurkeDirector, IR &
Corporate Communications510.665.7269
US-18-01-00344
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 3.2iii 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
CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (In thousands, except per share
amounts) (Unaudited) |
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2018 |
|
|
2017 |
|
2018 |
|
|
2017 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues,
net |
$ |
1,254 |
|
|
|
$ |
- |
|
|
$ |
1,419 |
|
|
|
$ |
- |
|
Grant revenue |
|
- |
|
|
|
|
105 |
|
|
|
- |
|
|
|
|
253 |
|
Total
revenues |
|
1,254 |
|
|
|
|
105 |
|
|
|
1,419 |
|
|
|
|
253 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales -
product |
|
5,177 |
|
|
|
|
- |
|
|
|
5,382 |
|
|
|
|
- |
|
Cost of sales -
amortization of intangible assets |
|
2,298 |
|
|
|
|
- |
|
|
|
4,715 |
|
|
|
|
- |
|
Research and
development |
|
16,273 |
|
|
|
|
14,814 |
|
|
|
35,239 |
|
|
|
|
31,159 |
|
Selling, general and
administrative |
|
15,653 |
|
|
|
|
5,612 |
|
|
|
32,544 |
|
|
|
|
12,084 |
|
Restructuring |
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
|
2,783 |
|
Total operating
expenses |
|
39,401 |
|
|
|
|
20,426 |
|
|
|
77,880 |
|
|
|
|
46,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(38,147 |
) |
|
|
|
(20,321 |
) |
|
|
(76,461 |
) |
|
|
|
(45,773 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
1,153 |
|
|
|
|
235 |
|
|
|
1,893 |
|
|
|
|
380 |
|
Interest expense |
|
(2,691 |
) |
|
|
|
- |
|
|
|
(3,852 |
) |
|
|
|
- |
|
Other income (expense),
net |
|
241 |
|
|
|
|
(232 |
) |
|
|
18 |
|
|
|
|
(212 |
) |
Net
loss |
$ |
(39,444 |
) |
|
|
$ |
(20,318 |
) |
|
$ |
(78,402 |
) |
|
|
$ |
(45,605 |
) |
Basic and
diluted net loss per share |
$ |
(0.63 |
) |
|
|
$ |
(0.41 |
) |
|
$ |
(1.26 |
) |
|
|
$ |
(1.00 |
) |
Weighted
average shares used to compute basic and diluted net loss per
share |
|
62,346 |
|
|
|
|
49,700 |
|
|
|
62,047 |
|
|
|
|
45,787 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DYNAVAX TECHNOLOGIES
CORPORATION SELECTED BALANCE SHEET
DATA (In
thousands) (Unaudited) |
|
|
June 30, |
|
|
December 31, |
|
2018 |
|
|
2017 |
Assets |
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
216,043 |
|
|
$ |
191,854 |
Inventories |
|
5,112 |
|
|
|
312 |
Property and equipment,
net |
|
16,240 |
|
|
|
16,619 |
Intangible assets,
net |
|
16,364 |
|
|
|
1,306 |
Goodwill |
|
2,189 |
|
|
|
2,244 |
Other assets |
|
7,915 |
|
|
|
6,450 |
Total
assets |
$ |
263,863 |
|
|
$ |
218,785 |
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Total current
liabilities |
$ |
25,522 |
|
|
$ |
18,593 |
Total long-term
liabilities |
|
107,028 |
|
|
|
643 |
Stockholders’
equity |
|
131,313 |
|
|
|
199,549 |
Total
liabilities and stockholders’ equity |
$ |
263,863 |
|
|
$ |
218,785 |
|
|
|
|
|
|
|
Dynavax Technologies (NASDAQ:DVAX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Dynavax Technologies (NASDAQ:DVAX)
Historical Stock Chart
From Sep 2023 to Sep 2024