Novavax Reports Fourth Quarter and Year-End 2014 Financial Results
February 26 2015 - 4:18PM
Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company
focused on the discovery, development and commercialization of
recombinant nanoparticle vaccines and adjuvants, today announced
its financial results for the fourth quarter and twelve months
ended December 31, 2014.
Corporate Highlights
Fourth Quarter and Subsequent Achievements:
RSV
- Initiated a Phase 2 clinical trial of its RSV F-Protein
nanoparticle vaccine candidate (RSV F Vaccine) in 1,600 elderly
adults (≥60 years of age);
- Received the U.S. Food and Drug Administration's (FDA) Fast
Track Designation of our RSV F Vaccine for protection of infants
via maternal immunization, which, among other advantages, provides
the potential for priority review (shorter Biologics License
Application review) that could result in improved timeline to
licensure;
- Initiated enrollment in a Phase 1 clinical trial of our RSV F
Vaccine in healthy children, the first study of this vaccine
candidate to be conducted in a pediatric population; and
- Presented new positive data from the first clinical study of
our RSV F Vaccine in women of childbearing age at the 8th Vaccine
& ISV Congress, showing 50% reduction in infection in the
vaccinated women relative to placebo. This data suggests that the
vaccine may be efficacious in future clinical testing.
Influenza
- Initiated a randomized, observer-blinded, dose-ranging Phase 2
clinical trial of our recombinant quadrivalent seasonal influenza
virus-like particle (VLP) vaccine candidate (Seasonal Influenza
VLP) in 400 healthy adults. This trial is being conducted under our
contract with the U.S. Department of Health and Human Services,
Biomedical Advanced Research and Development Authority (BARDA)
(Contract No. HHSO 100201100012C) for the development of Novavax'
recombinant vaccines to address seasonal influenza and influenza
strains with pandemic potential; and
- Received the FDA's Fast Track Designation of our Pandemic H7N9
Influenza VLP vaccine candidate (Pandemic H7N9 VLP) with Matrix-M™
adjuvant, which recognizes the public health risks of the H7N9
strain and may allow for an improved timeline to licensure via the
potential for accelerated approval and priority review.
Ebola
- Initiated a novel Ebola Glycoprotein (GP) recombinant
nanoparticle vaccine candidate (EBOV GP Vaccine) program based on
the currently circulating Makona strain (previously referred to as
the Guinea strain) of Ebola virus;
- Presented positive pre-clinical results at the 8th Vaccine
& ISV Congress of our EBOV GP Vaccine with Matrix-M adjuvant,
showing seroprotective antibodies and cross-neutralization to a
previously circulating Ebola virus strain;
- Announced significant immunogenicity and efficacy data
demonstrating the EBOV GP Vaccine is the first subunit Ebola
GP-based vaccine to provide protection in non-human primates.
Non-human primates received two injections of a 5µg dose of the
EBOV GP Vaccine with Matrix-M adjuvant. As expected, the challenge
was lethal for the control animal whereas, in sharp contrast, 100%
of the immunized animals were protected; and
- Initiated a randomized, observer-blinded, dose-ranging Phase 1
clinical trial of our EBOV GP Vaccine in Australia to evaluate the
safety and immunogenicity of the vaccine, with and without Matrix-M
adjuvant, in 230 healthy adults between 18 and 50 years of
age.
2015 Anticipated Events:
- Announce top-line data from the Phase 1 clinical trial our EBOV
GP Vaccine in mid-2015;
- Announce top-line data from the Phase 2 clinical trial of our
Seasonal Influenza VLP in the second quarter of 2015;
- Announce top-line data from the Phase 2 clinical trial of our
RSV F Vaccine in healthy women in their third trimester of
pregnancy in the third quarter of 2015;
- Announce top-line data from the Phase 2 clinical trial of our
RSV F Vaccine in elderly adults in the third quarter of 2015;
and
- Announce top-line data from the Phase 1 clinical trial of our
RSV F Vaccine in healthy pediatrics in late 2015 or in the first
half of 2016.
"We have initiated five clinical trials within the last six
months, including advancing both our RSV and seasonal influenza
programs into Phase 2 clinical trials, while introducing our new
Ebola vaccine into the clinic," said Stanley C. Erck, President and
Chief Executive Officer of Novavax. "These achievements underscore
the strength of our vaccine technology, capability of our
manufacturing platform and experience of our leadership team. We
look forward to carrying this momentum through 2015, with important
clinical data readouts expected in our RSV, seasonal influenza and
Ebola programs."
Financial Results for the Three and Twelve Months Ended
December 31, 2014
Novavax reported a net loss of $31.5 million, or $0.13 per
share, for the fourth quarter of 2014, compared to a net loss of
$14.1 million, or $0.07 per share, for the fourth quarter of 2013.
For the twelve months ended December 31, 2014, the net loss was
$82.9 million, or $0.37 per share, compared to a net loss of $52.0
million, or $0.31 per share for 2013.
Novavax revenue in the fourth quarter of 2014 decreased 23% to
$6.7 million, compared to $8.7 million for the same period in 2013.
Revenue for the full year 2014 increased 47% to $30.7 million,
compared to $20.9 million in 2013. The increase in the full year
revenue results from the Phase 1/2 clinical trial of our H7N9
pandemic influenza vaccine candidate with Matrix-M and activities
relating to the preparation and initiation of the Phase 2 clinical
trial of our Seasonal Influenza VLP; both programs are funded under
our contract with HHS BARDA.
The cost of government contracts revenue in the fourth quarter
of 2014 increased 9% to $2.8 million, compared to $2.6 million for
the same period in 2013. For the full year 2014, cost of government
contracts revenue increased 82% to $15.0 million, compared to $8.2
million in 2013. The increase in costs for the full year 2014 were
associated with the Phase 1/2 clinical trial of our H7N9 pandemic
influenza candidate with Matrix-M adjuvant and activities relating
to the preparation and initiation of the Phase 2 clinical trial of
our Seasonal Influenza VLP; both programs are funded under our
contract with HHS BARDA.
Research and development expenses increased 87% to $30.5 million
in the fourth quarter of 2014, compared to $16.3 million for the
same period in 2013. For the full year 2014, research and
development expenses increased 58% to $79.4 million, compared to
$50.3 million in 2013. The increase in research and development
expenses for the full year 2014 is driven by activities relating to
the preparation and initiation of three RSV F Vaccine candidate
clinical trials in 2014, the initiation of our Ebola vaccine
candidate program and higher employee-related expenses tied to the
continued growth of the company.
General and administrative expenses increased 24% to $5.1
million in the fourth quarter of 2014, compared to $4.1 million for
the same period in 2013. For the full year 2014, general and
administrative expenses increased 34% to $19.9 million, compared to
$14.8 million in 2013. The increase in general and administrative
expenses for the full year 2014 resulted from increased
employee-related expenses tied to the continued growth of the
company.
As of December 31, 2014, the company had $168.1 million in cash
and cash equivalents and marketable securities compared to $133.1
million as of December 31, 2013. Net cash used in operating
activities for 2014 was $67.0 million, compared to $45.4 million
for 2013. The factors contributing to the change in cash usage were
primarily due to increased costs relating to our RSV F Vaccine
candidate and higher employee-related costs, as well as the timing
of vendor payments.
Conference Call
Novavax management will host its quarterly conference call today
at 4:30 p.m. EDT. The dial-in number for the conference call is
877-212-6076 (U.S. or Canada) or 707-287–9331 (International). A
webcast of the conference call can also be accessed via a link on
the home page of the Novavax website (novavax.com) or through the
"Investor Info"/"Events" tab on the Novavax website.
A replay of the conference call will be available starting at
7:30 p.m. on February 26, 2015 until midnight March 5, 2015. To
access the replay by telephone, dial 855-859-2056 (Domestic) or
404-537-3406 (International) and use passcode 89629680. The replay
will also be available as a webcast and can be found on the
"Investor Info"/"Events" on the Novavax website.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company
committed to delivering novel products to prevent a broad range of
infectious diseases. Our recombinant nanoparticles and Matrix-M™
adjuvant technology are the foundation for groundbreaking
innovation that improves global health through safe and effective
vaccines. Additional information about Novavax is available on the
company's website, novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the
ongoing development of its vaccine and adjuvant products are
forward-looking statements. Novavax cautions that these forward
looking statements are subject to numerous risks and uncertainties,
which could cause actual results to differ materially from those
expressed or implied by such statements. These risks and
uncertainties include those identified under the heading "Risk
Factors" in the Novavax Annual Report on Form 10-K for the year
ended December 31, 2014, to be filed with the Securities and
Exchange Commission (SEC). We caution investors not to place
considerable reliance on the forward-looking statements contained
in this press release. You are encouraged to read our filings with
the SEC, available at sec.gov, for a discussion of these and other
risks and uncertainties. The forward-looking statements in this
press release speak only as of the date of this document, and we
undertake no obligation to update or revise any of the statements.
Our business is subject to substantial risks and uncertainties,
including those referenced above. Investors, potential investors,
and others should give careful consideration to these risks and
uncertainties.
|
NOVAVAX,
INC. |
CONDENSED STATEMENTS OF
OPERATIONS |
(in thousands, except
per share information) |
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
Twelve Months
Ended |
|
December
31, |
December
31, |
|
2014 |
2013 |
2014 |
2013 |
|
(unaudited) |
|
|
Revenue |
$ 6,724 |
$ 8,748 |
$ 30,659 |
$ 20,915 |
|
|
|
|
|
Costs and expenses: |
|
|
|
|
Cost of government contracts
revenue |
2,837 |
2,602 |
14,987 |
8,222 |
Research and development |
30,495 |
16,319 |
79,435 |
50,308 |
General and administrative |
5,056 |
4,080 |
19,928 |
14,819 |
Total costs and expenses |
38,388 |
23,001 |
114,350 |
73,349 |
Loss from operations |
(31,664) |
(14,253) |
(83,691) |
(52,434) |
Interest income (expense), net |
118 |
10 |
129 |
27 |
Other income, net |
― |
192 |
― |
182 |
Realized gains on marketable securities |
― |
― |
615 |
― |
Change in fair value of warrant
liability |
― |
― |
― |
267 |
Loss from operations before income tax
expense |
(31,546) |
(14,051) |
(82,947) |
(51,958) |
Income tax expense |
― |
3 |
― |
25 |
Net loss |
$ (31,546) |
$ (14,054) |
$ (82,947) |
$ (51,983) |
|
|
|
|
|
Basic and diluted net loss per share |
$ (0.13) |
$ (0.07) |
$ (0.37) |
$ (0.31) |
Basic and diluted weighted average number of
common shares outstanding |
238,519 |
208,538 |
225,848 |
169,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED BALANCE SHEET
DATA |
(in
thousands) |
|
|
|
|
December 31, |
December 31, |
|
2014 |
2013 |
|
|
|
Cash and cash equivalents |
$ 32,335 |
$ 119,471 |
Marketable securities |
135,721 |
13,597 |
Total current assets |
188,158 |
145,001 |
Working capital |
154,042 |
126,879 |
Total assets |
276,002 |
235,125 |
Total notes payable and capital lease
obligations |
1,173 |
2,184 |
Total stockholders' equity |
229,618 |
203,234 |
|
|
|
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
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