Update on Initial Progress of HEPLISAV-B®
Commercial Launch
Dynavax Technologies Corporation (NASDAQ:DVAX) today reported
financial results for the first quarter ended March 31, 2018. The
net loss for the quarter ended March 31, 2018, was $39.0
million, or $0.63 per share, compared to $25.3
million, or $0.60 per share, for the quarter ended March
31, 2017. Cash, cash equivalents and marketable securities totaled
$250.8 million at March 31, 2018.
Recent
HighlightsHEPLISAV-B® [Hepatitis B
Vaccine, Recombinant (Adjuvanted)]
- CDC’s Advisory Committee on Immunization Practices’ (ACIP)
recommendation of HEPLISAV-B published in Morbidity and Mortality
Weekly Report (MMWR) supports payer coverage, removing a major
barrier for adoption
- 100% of Medicare-insured lives, 74% of commercially-insured
lives, and 60% of lives under state Medicaid plans have HEPLISAV-B
specific Current Procedural Terminology (CPT) code loaded,
are referencing the correct price, and have confirmed provider
claims will be reimbursed. These coverage metrics have been
achieved just two weeks after the publication of the MMWR
- In first 60 days following sales force launch in late February,
the field sales team met with two-thirds of targeted key accounts,
representing over half of addressable market
Immuno-Oncology
- Data abstract for Phase 1b/2 study investigating SD-101 in
combination with KEYTRUDA® in advanced melanoma selected for Poster
Discussion Session at 2018 American Society of Clinical Oncology
(ASCO) Annual Meeting
- Data from ongoing Phase 1b/2 study of SD-101 and KEYTRUDA
combination therapy presented at the 2018 American
Association for Cancer Research (AACR) Annual Meeting
- Meaningful response in advanced head and neck squamous cell
carcinoma – overall response rate of 33% (6 out of 18) (38%
among patients who received at least one scan on study)
- Well-tolerated in advanced melanoma, showed no increase in
frequency of immune-related adverse events over individual
monotherapies, nor evidence of a unique safety signal; 86% (6 out
of 7) of initial responses naïve to anti-PD-1/L1 treatment were
ongoing after a median of 18 months of follow up
Financials
- $250.8 million in cash, cash equivalents and marketable
securities at end of first quarter, with $75 million available from
February 2018 term loan agreement
- Funds commercialization of HEPLISAV-B to time of expected
positive cash flow and supports further immuno-oncology clinical
research
“We have made significant progress since the beginning of the
year,” said Eddie Gray, Chief Executive Officer. “Our sales force
has begun engaging with most of our larger potential customers. We
are delighted by the level of initial interest reinforcing our view
that HEPLISAV-B will become the standard of care for adult
hepatitis-B vaccination and reach a goal of obtaining positive cash
flow by the end of 2019.”
“In addition, we see substantial potential upside from our
immuno-oncology programs. SD-101 has been shown to generate
antitumor activity in three tumor types while being well tolerated.
We have funding to continue supporting new clinical trials and
advancement of SD-101 into a registrational study in 2018,” Mr.
Gray concluded.
Additional Financial ResultsNet product revenue
was $0.2 million for the quarter ended March 31, 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 $0.2 million for the quarter ended
March 31, 2018 and consists of certain fill, finish and fixed
overhead costs for HEPLISAV-B incurred after FDA approval.
Cost of sales, amortization of intangible assets was $2.4
million for the quarter ended March 31, 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 March 31, 2018 and
2017, were $19.0 million and $16.3 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, costs associated with resuming
operating activities at our Dusseldorf production facility and
costs associated with manufacturing of pre-filled syringes prior to
regulatory approval.
Selling, general and administrative expenses for the quarter
ended March 31, 2018 and 2017, were $16.9 million and $6.5 million,
respectively. The increase is 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 (866) 548-4713 in the U.S. or
(323) 794-2093 internationally, and use the conference ID 8635193.
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
8635193.
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.
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 MEL-01 (KEYNOTE-184)The dose-escalation
and expansion study of SD-101 in combination with KEYTRUDA includes
patients with histologically or cytologically confirmed
unresectable Stage IIIc/IV melanoma. The primary endpoints of the
trial are MTD and evaluation of the safety of intratumoral SD-101
in combination with KEYTRUDA. In addition, the trial is
investigating response as assessed by the investigator according to
RECIST v1.1, biomarker assessments and duration of response.
Patients previously treated with anti-PD-1 and other
immunotherapies are included.
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 metastatic 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 DV281DV281 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 aerosol. Both SD-101 and DV281 are designed to
activate plasmacytoid dendritic cells and 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. Dynavax has initiated dosing in a phase 1B dose
escalation clinical trial of DV281 in patients with non-small cell
lung cancer.
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], is approved in the United States. 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. These statements are subject
to a number of risks and uncertainties that could cause actual
results to differ materially, including whether the company will be
able to continue building the commercial infrastructure required to
successfully launch HEPLISAV-B; whether payers will provide timely
reimbursement for HEPLISAV-B; whether prescribers and other key
decision-makers will switch to HEPLISAV-B; whether potential claims
against us, including those based on patent rights of others, will
result in an injunction against sales or otherwise impact
commercialization and sales; and the uncertain clinical development
process, the outcome, cost and timing of our product development
activities, our ability to obtain and maintain regulatory approval
of our product candidates. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the business of Dynavax in general, see risks
detailed in the "Risk Factors" section of our most recent current
periodic report filed with the SEC. These statements represent our
estimates and assumptions only as of the date of this press
release. We do not undertake any obligation to update publicly any
such forward-looking statements, 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-18-01-00023
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 CORPORATION |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(In thousands, except per share
amounts) |
(Unaudited) |
|
|
Three Months Ended |
|
March 31, |
|
2018 |
|
2017 |
Revenues: |
|
|
|
|
|
Product
revenues, net |
$ |
165 |
|
$ |
- |
Grant
revenue |
|
- |
|
|
148 |
Total
revenues |
|
165 |
|
|
148 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Cost of sales -
product |
|
205 |
|
|
- |
Cost of
sales - amortization of intangible assets |
|
2,417 |
|
|
- |
Research
and development |
|
18,966 |
|
|
16,345 |
Selling,
general and administrative |
|
16,891 |
|
|
6,472 |
Restructuring |
|
- |
|
|
2,783 |
Total operating
expenses |
|
38,479 |
|
|
25,600 |
|
|
|
|
|
|
Loss from
operations |
|
(38,314) |
|
|
(25,452) |
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
Interest
income |
|
740 |
|
|
145 |
Interest
expense |
|
(1,161) |
|
|
- |
Other
(expense) income, net |
|
(223) |
|
|
20 |
Net
loss |
$ |
(38,958) |
|
$ |
(25,287) |
Basic and
diluted net loss per share |
$ |
(0.63) |
|
$ |
(0.60) |
Weighted
average shares used to compute basic and diluted net loss per
share |
|
61,744 |
|
|
41,830 |
|
|
|
|
|
|
DYNAVAX TECHNOLOGIES CORPORATION |
SELECTED BALANCE SHEET DATA |
|
(In thousands) |
|
(Unaudited) |
|
|
|
March 31, |
|
December 31, |
|
2018 |
|
2017 |
Assets |
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
$ |
250,780 |
|
$ |
191,854 |
Property
and equipment, net |
|
17,064 |
|
|
16,619 |
Intangible assets, net |
|
18,662 |
|
|
1,306 |
Goodwill |
|
2,309 |
|
|
2,244 |
Other
assets |
|
6,518 |
|
|
6,762 |
Total
assets |
$ |
295,333 |
|
$ |
218,785 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Total
current liabilities |
$ |
23,542 |
|
$ |
18,593 |
Total
long-term liabilities |
|
105,904 |
|
|
643 |
Stockholders’ equity |
|
165,887 |
|
|
199,549 |
Total
liabilities and stockholders’ equity |
$ |
295,333 |
|
$ |
218,785 |
|
|
|
|
|
|
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