UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event
reported): February 26, 2015
NOVAVAX, INC.
(Exact name of registrant as specified
in charter)
Delaware |
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0-26770 |
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22-2816046 |
(State or Other Jurisdiction
of Incorporation) |
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(Commission File Number) |
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(I.R.S. Employer
Identification
No.) |
20 Firstfield Road
Gaithersburg, Maryland 20878
(Address of Principal Executive Offices,
including Zip Code)
(240) 268-2000
(Registrant’s telephone number,
including area code)
(Former name or former
address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
¨ Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial
Condition.
Fourth Quarter Financial Results
On February 26,
2015, Novavax, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the
quarter ended December 31, 2014. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information
in Items 2.02 and 9.01 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section,
nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act except as expressly
set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
Exhibit No. |
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Description |
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99.1 |
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Press release, dated February 26, 2015, regarding the Company’s financial results for the quarter ended December 31, 2014. |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Novavax, Inc. |
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(Registrant) |
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Date: February 27, 2015 |
By: |
/s/ John A. Herrmann III |
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Name: Title: |
John A. Herrmann III Senior Vice President, General Counsel and Corporate Secretary |
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EXHIBIT INDEX
Exhibit No. |
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Description |
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99.1 |
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Press release, dated February 26, 2015, regarding the Company’s financial results for the quarter ended December 31, 2014. |
Exhibit 99.1
Novavax Reports Fourth Quarter and Year-End
2014 Financial Results
Gaithersburg, MD (February 26, 2015)
- 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 year ended 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.
###
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December 31, | | |
December 31, | |
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2014 | | |
2013 | | |
2014 | | |
2013 | |
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(unaudited) | | |
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Revenue | |
$ | 6,724 | | |
$ | 8,748 | | |
$ | 30,659 | | |
$ | 20,915 | |
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| | | |
| | | |
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Costs and expenses: | |
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| | | |
| | | |
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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 | ) |
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| | | |
| | | |
| | | |
| | |
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,
2014 | | |
December 31,
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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