Conference Call to be held Today at 4:30pm
ET/1:30pm PT
Dynavax Technologies Corporation (NASDAQ: DVAX) today reported
financial results for the third quarter ended September 30, 2018
along with an update on the launch progress of HEPLISAV-B and an
overview of recently presented data for SD-101 in combination with
KEYTRUDA®.
Recent Highlights
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted]
- P&T approval in six of the top ten integrated delivery
networks
- 402 of the largest targeted customers have received P&T
committee approval, of whom 200 have progressed to purchase and 68
have implemented HEPLISAV-B throughout their system
- Another 291 target customers have sub-committee or P&T
committee reviews scheduled
- Q3 sales of $1.5 million compared to $1.2 million in Q2
Immuno-oncology
Encouraging results for SD-101 Phase 1b/2 data in combination
with KEYTRUDA® presented at the ESMO 2018 Congress:
- In 47 advanced melanoma patients naïve to anti PD-1 therapy who
received 2mg dose:-- Overall response rate (ORR) of 70%, identical
ORR to previous report at ASCO with a greater than 50 percent
increase in number of patients-- 85% 6-month progression-free
survival (PFS) rate-- Observed responses in injected lesion(s) and
non-injected distant lesions, including visceral metastases in the
liver and lung-- Responses were independent of baseline PD-L1
expression-- Adverse events related to SD-101 treatment were
transient, mild to moderate flu-like symptoms
- 21.4 percent ORR in 29 melanoma patients refractory or
resistant to anti-PD-1 therapy who received the 8 mg dose
- 27.3% ORR in 22 patients with head and neck squamous cell
carcinoma who were naïve to anti-PD-1 and received the 8 mg
dose
- End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) completed
“We achieved multiple objectives over the past few months in
both the HEPLISAV-B commercial program and the SD-101 clinical
program. Our HEPLISAV-B results in September and particularly
October, together with our projections for November and December
give us confidence we are now experiencing the start of the
inflection in HEPLISAV-B sales we consistently have anticipated for
year end. We remain firm in our expectation that HEPLISAV-B
will become cash generative before the end of 2019,” said Eddie
Gray, chief executive officer of Dynavax. “In addition, our
studies of SD-101 in combination with pembrolizumab continue to
generate consistent, encouraging results beyond those reported with
monotherapy. We are evaluating multiple opportunities,
including partnerships, expansion of tumor types under study and
selection of best options for progression into registrational
studies.”
Financial ResultsCash, cash equivalents and
marketable securities totaled $180.2 million at September 30, 2018,
compared to $216 million at June 30, 2018, with $75 million
available from our term loan agreement.
Dynavax’s first commercial product, HEPLISAV-B, was launched in
the first quarter of 2018 and net product revenue for the three and
nine months ended September 30, 2018 were $1.5 million and $2.9
million, respectively. 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 $3.9 million and $9.3 million for the
three and nine months ended September 30, 2018 and consists of
inventory reserves and fill, finish and overhead costs incurred
after FDA approval for the vial presentation of HEPLISAV-B.
Also included are costs associated with resuming operations
at our manufacturing facility in Dusseldorf after receiving
regulatory approval for the pre-filled syringe presentation, which
costs previously were included in research and development
expense.
Research and development expenses for the three months ended
September 30, 2018 and 2017, were $16.8 million and $16.4 million,
respectively. Research and development expenses for the nine
months ended September 30, 2018 and 2017, were $52.1 million and
$47.6 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. Upon approval of pre-filled syringes in Q1, 2018,
costs associated with resuming activities at our manufacturing
facility in Dusseldorf were charged to cost of sales-product while
costs incurred to manufacture HEPLISAV-B for commercial sale were
accounted for as inventory.
Selling, general and administrative expenses for the three
months ended September 30, 2018 and 2017, were $15.8 million and
$6.0 million, respectively. Selling, general and administrative
expenses for the nine months ended September 30, 2018 and 2017 were
$48.3 million and $18.1 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.
The net loss for the third quarter of 2018 was $40.5
million, or $0.65 per share, compared to $22.1
million, or $0.38 per share, for the third quarter of
2017. The net loss for the nine-month period ended September
30, 2018 was $118.9 million, or $1.91 per share,
compared to $67.7 million, or $1.36 per share, for
the same period in 2017.
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 (866) 420-4066 in the U.S. or
(409) 217-8237 internationally, and use the conference ID 5179228.
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-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 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 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, including projected
sales and profitability levels, 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 June 30, 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: Ryan SpencerVP Corporate Strategy and
Communications(510) 665-4618
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 |
|
Nine Months Ended |
|
September 30, |
|
|
September 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Product revenues,
net |
$ |
1,461 |
|
$ |
|
- |
|
|
$ |
2,880 |
|
|
$ |
- |
|
Grant revenue |
|
- |
|
|
|
53 |
|
|
|
- |
|
|
|
306 |
|
Total
revenues |
|
1,461 |
|
|
|
53 |
|
|
|
2,880 |
|
|
|
306 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of sales -
product |
|
3,927 |
|
|
|
- |
|
|
|
9,309 |
|
|
|
- |
|
Cost of sales -
amortization of intangible assets |
|
3,823 |
|
|
|
- |
|
|
|
8,538 |
|
|
|
- |
|
Research and
development |
|
16,820 |
|
|
|
16,417 |
|
|
|
52,059 |
|
|
|
47,576 |
|
Selling, general and
administrative |
|
15,788 |
|
|
|
6,027 |
|
|
|
48,332 |
|
|
|
18,111 |
|
Restructuring |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,783 |
|
Total operating
expenses |
|
40,358 |
|
|
|
22,444 |
|
|
|
118,238 |
|
|
|
68,470 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(38,897 |
) |
|
|
(22,391 |
) |
|
|
(115,358 |
) |
|
|
(68,164 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
1,047 |
|
|
|
429 |
|
|
|
2,940 |
|
|
|
809 |
|
Interest expense |
|
(2,735 |
) |
|
|
- |
|
|
|
(6,587 |
) |
|
|
- |
|
Other income (expense),
net |
|
57 |
|
|
|
(166 |
) |
|
|
75 |
|
|
|
(378 |
) |
Net
loss |
$ |
(40,528 |
) |
|
$ |
(22,128 |
) |
|
$ |
(118,930 |
) |
|
$ |
(67,733 |
) |
Basic and
diluted net loss per share |
$ |
(0.65 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.91 |
) |
|
$ |
(1.36 |
) |
Weighted
average shares used to compute basic and diluted net loss per
share |
|
62,650 |
|
|
|
57,650 |
|
|
|
62,250 |
|
|
|
49,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DYNAVAX TECHNOLOGIES CORPORATION |
|
SELECTED BALANCE SHEET DATA |
|
(In thousands) |
|
(Unaudited) |
|
|
September 30, |
|
|
December 31, |
|
|
2018 |
|
|
2017 |
|
Assets |
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
180,221 |
|
|
$ |
191,854 |
|
Inventories |
|
12,452 |
|
|
|
312 |
|
Property and equipment,
net |
|
16,933 |
|
|
|
16,619 |
|
Intangible assets,
net |
|
14,041 |
|
|
|
1,306 |
|
Goodwill |
|
2,174 |
|
|
|
2,244 |
|
Other assets |
|
10,567 |
|
|
|
6,450 |
|
Total
assets |
$ |
236,388 |
|
|
$ |
218,785 |
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Total current
liabilities |
$ |
31,598 |
|
|
$ |
18,593 |
|
Total long-term
liabilities |
|
107,777 |
|
|
|
643 |
|
Stockholders’
equity |
|
97,013 |
|
|
|
199,549 |
|
Total
liabilities and stockholders’ equity |
$ |
236,388 |
|
|
$ |
218,785 |
|
|
|
|
|
|
|
|
|
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