Novavax Reports First Quarter 2015 Financial Results
May 07 2015 - 3:26PM
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 first quarter 2015.
Corporate Highlights
First Quarter and Subsequent Achievements:
RSV
- Completed enrollment of two ongoing clinical trials of its RSV
F Vaccine, including a Phase 2 study in elderly adults (60 years of
age and older) and a Phase 2 trial to protect infants via maternal
immunization.
Ebola
- 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-MTM adjuvant, in 230 healthy adults between 18 and 50 years
of age.
Corporate Achievements
- Completed an underwritten public offering of approximately 27.8
million shares, including shares pursuant to the underwriters’
option, at $7.25 per share resulting in total gross proceeds from
this offering of approximately $201 million before deducting the
underwriters discount and offering expenses; and
- Awarded 2015 Workplace Excellence Seal of Approval from the
Alliance of Workplace Excellence. Companies awarded the Workplace
Excellence Seal of Approval demonstrate outstanding commitments to
innovative corporate culture and management practices, employee
growth and learning opportunities, diversity and inclusion
practices and commitment to corporate, social and civic
responsibilities.
2015 Anticipated Events
- During the third quarter of 2015, announce top-line clinical
data from four of our ongoing clinical trials, including:
- Phase 2 clinical trial of the RSV F Vaccine in elderly
adults;
- Phase 2 clinical trial of the RSV F Vaccine in Phase 2 study to
protect infants via maternal immunization;
- Phase 2 clinical trial of the Quadrivalent Seasonal Influenza
VLP; and
- Phase 1 clinical trial of the EBOV GP Vaccine in healthy
adults.
“Novavax has now completed enrollment of the elderly and
maternal immunization RSV clinical trials. That achievement,
combined with our ongoing Quadrivalent Seasonal Influenza VLP
vaccine and Ebola GP Vaccine clinical trials, will position us for
significant clinical data readouts in the second half of 2015,”
said Stanley C. Erck, President and Chief Executive Officer of
Novavax. “Our March 2015 financing provided us with the resources
to prepare for the next steps, with our key objective to continue
to execute our aggressive RSV F Vaccine development plans.”
Financial Results for the Three Months Ended March 31,
2015
Novavax reported a net loss of $24.4 million, or $0.10 per
share, for the first quarter of 2015, compared to a net loss of
$13.8 million, or $0.07 per share, for the first quarter of
2014.
Novavax revenue in the first quarter of 2015 increased 32% to
$9.9 million, compared to $7.5 million for the same period in 2014.
The increase results primarily from HHS BARDA’s approval of the
reimbursement of the Company’s prior Phase 2 Quadrivalent Seasonal
Influenza VLP vaccine clinical trial (205 Trial) costs, resulting
in an additional $3.1 million in revenue in the quarter.
The cost of government contracts revenue in the first quarter of
2015 decreased 19% to $2.5 million, compared to $3.0 million for
the same period in 2014. The decrease in costs were associated with
a lower level of activity in the first quarter of 2015 associated
with the Company’s Phase 2 clinical trial of our quadrivalent
seasonal influenza vaccine candidate as compared to the Company’s
Phase 1/2 clinical trial of our H7N9 pandemic influenza candidate
with Matrix-M in the same period in 2014; both programs are funded
under our contract with HHS BARDA.
Research and development expenses increased 78% to $25.9 million
in the first quarter of 2015, compared to $14.5 million for the
same period in 2014. The increase in research and development
expenses was driven by activities relating to the ongoing RSV F
Vaccine clinical trials, the initiation of the Phase 1 clinical
trial of our Ebola GP Vaccine candidate program and higher
employee-related expenses tied to the continued growth of the
Company.
General and administrative expenses increased 36% to $5.8
million in the first quarter of 2015, compared to $4.3 million for
the same period in 2014. The increase in general and administrative
expenses resulted from increased employee-related expenses tied to
the continued growth of the Company.
As of March 31, 2015, the Company had $327.7 million in cash and
cash equivalents and marketable securities compared to $168.1
million as of December 31, 2014. Net cash used in operating
activities for the first quarter of 2015 was $30.5 million,
compared to $20.4 million for the same period in 2014. The factors
contributing to the change in operating cash usage were primarily
due to increased research and development costs relating to our
vaccine candidates and higher employee-related costs, as well as
the timing of customer and 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 (Domestic) 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 May 7, 2015 until midnight May 14, 2015. To access the
replay by telephone, dial (855) 859-2056 (Domestic) or (404)
537–3406 (International) and use passcode 35660022. 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, 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
CONSOLIDATED STATEMENTS OF OPERATIONS |
(in thousands,
except per share information) |
|
|
|
|
|
|
|
Three Months
Ended |
|
March
31, |
|
|
2015 |
|
|
2014 |
|
|
(unaudited) |
Revenue |
$ |
9,877 |
|
$ |
7,462 |
|
|
|
|
Costs and expenses: |
|
|
Cost of government contracts
revenue |
|
2,459 |
|
|
3,021 |
|
Research and development |
|
25,888 |
|
|
14,518 |
|
General and administrative |
|
5,843 |
|
|
4,308 |
|
Total costs and expenses |
|
34,190 |
|
|
21,847 |
|
Loss from operations |
|
(24,313 |
) |
|
(14,385 |
) |
Interest income (expense), net |
|
85 |
|
|
(40 |
) |
Other expense |
|
(142 |
) |
― |
Realized gains on marketable securities |
― |
|
615 |
|
Net loss |
$ |
(24,370 |
) |
$ |
(13,810 |
) |
|
|
|
Basic and diluted net loss per share |
$ |
(0.10 |
) |
$ |
(0.07 |
) |
Basic and diluted weighted average |
|
|
number of common shares
outstanding |
|
241,223 |
|
|
208,927 |
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA |
(in
thousands) |
|
|
March
31, 2015 |
|
December 31,
2014 |
|
(unaudited) |
|
|
Cash and cash equivalents |
$ |
215,050 |
|
|
$ |
32,335 |
|
Marketable securities |
|
112,685 |
|
|
|
135,721 |
|
Total current assets |
|
350,094 |
|
|
|
188,158 |
|
Working capital |
|
321,318 |
|
|
|
154,042 |
|
Total assets |
|
438,841 |
|
|
|
276,002 |
|
Total notes payable and capital lease
obligations |
|
990 |
|
|
|
1,173 |
|
Total stockholders’ equity |
|
399,706 |
|
|
|
229,618 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
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