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): November 9, 2015
NOVAVAX, INC.
(Exact name of registrant as specified
in charter)
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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.)
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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.
Third Quarter Financial Results
On November 9,
2015, Novavax, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the
quarter ended September 30, 2015. 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.
(d) Exhibits
Exhibit
No. |
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Description |
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99.1 |
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Press release, dated November 9, 2015, regarding the Company’s financial results for the quarter ended September 30, 2015. |
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. (Registrant) |
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Date: November 9, 2015 |
By: |
/s/ John A. Herrmann III |
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Name: |
John A. Herrmann III |
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Title: |
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 November 9, 2015, regarding the Company’s financial results for the quarter ended September 30, 2015. |
Novavax Reports Third Quarter 2015 Financial
Results
Gaithersburg, Md., November 9, 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 third quarter and nine months ended
September 30, 2015.
Novavax Third Quarter and Subsequent
Achievements
| · | Announced
positive top-line data from a Phase 2 clinical trial of its RSV F-protein recombinant
nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older).
The vaccine was well-tolerated and fulfilled the Company's expectations on the primary,
secondary and exploratory objectives of the trial. The trial is the first to demonstrate
efficacy of an active RSV immunization in any clinical trial population. |
| · | Announced
positive top-line data from a Phase 2 clinical trial of its RSV F Vaccine to protect
infants via maternal immunization. Significant anti-F, PCA and microneutralizing antibody
responses were elicited in mothers and efficient antibody transfer from mothers to infants
was observed. |
| · | Announced
that it has been awarded a grant of up to $89 million by the Bill & Melinda Gates
Foundation to support development of the RSV F Vaccine Phase 3 clinical trial in pregnant
women. This grant will also support regulatory licensing efforts, providing a path to
WHO prequalification. Upon licensure, Novavax has agreed to make the RSV F
Vaccine affordable and accessible to people in the developing world. |
| · | Announced
positive top-line data from a Phase 1 clinical trial of its RSV F Vaccine in healthy
children two to six years of age. All RSV F Vaccine formulations and regimens were well-tolerated
and highly immunogenic. |
| · | Commenced
enrollment in a Phase 2 rollover clinical trial of its RSV F Vaccine in older adults.
The trial is a randomized, observer-blinded, placebo-controlled rollover trial designed
to enroll the same 1600 older adults who participated in the recently concluded prior
Phase 2 trial. |
| · | Announced
positive top-line data from a Phase 2 trial of its recombinant quadrivalent seasonal
influenza virus-like particle candidate (Quadrivalent Seasonal Influenza VLP). The trial,
funded in whole or part with Federal funds from the Company’s contract with the
Department of Health and Human Services, Biomedical Advanced Research and Development
Authority (HHS BARDA) (Contract No. HHSO 100201100012C), demonstrated that the Quadrivalent
Seasonal Influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious
adverse events. The trial met its immunogenicity targets and demonstrated potential to
meet the Center for Biological Evaluation and Research (CBER) criteria for accelerated
approval. |
| · | Delivered
positive top-line data from a Phase 1 clinical trial of its Ebola virus glycoprotein
(GP) recombinant nanoparticle vaccine (Ebola GP Vaccine) candidate adjuvanted with Matrix-M™.
The trial demonstrated that the adjuvanted Ebola GP Vaccine was highly immunogenic, well-tolerated
and resulted in significant antigen dose-sparing. |
| · | Hosted
its 3rd Annual Analyst and Investor Meeting. |
Today’s Announcement
| · | Initiation
of a Phase 3 trial of the RSV F Vaccine in older adults |
Near-term Anticipated Events
| · | Initiation
of a Phase 3 trial of the RSV F Vaccine to protect infants via maternal immunization,
contingent upon discussions with regulatory authorities |
Summary
“The initiation of the first Phase
3 trial of our RSV F Vaccine in older adults underscores our accomplishments to date and positions the company to bring the first
RSV vaccine to market. Our recent data announcements demonstrate the safety and robust immunogenicity of the RSV F Vaccine across
all three target populations: older adults; infants via maternal immunization; and pediatrics,” said Gregory Glenn, M.D.,
Senior Vice President, Research and Development. “Our Phase 2 trial of the RSV F Vaccine in older adults was the first to
demonstrate efficacy of an active RSV immunization in any clinical trial population. In addition, data from pregnant women in
their third trimester provided an important safety data and proof-of-concept for maternal immunization, with a high level of transplacental
antibody transfer.”
“During the third quarter, we delivered
positive results from five key clinical programs including our RSV F Vaccine for older adults, infants via maternal immunization
and pediatrics, as well as our Seasonal Influenza Vaccine, and our Ebola GP Vaccine. These results, coupled with today’s
initiation of our Phase 3 trial of our RSV F Vaccine in older adults, demonstrate Novavax’ ability to successfully advance
our clinical stage programs along aggressive timelines,” said Stanley C. Erck, President and CEO. “With successful
phase 2 results, and consistent execution, the Company is well-positioned to begin our second phase 3 trial in pregnant women
in the first quarter of 2016.”
Financial Results for the Three and
Nine Months Ended September 30, 2015
Novavax reported a net loss of $33.1 million,
or $0.12 per share, for the third quarter of 2015, compared to a net loss of $19.7 million, or $0.08 per share, for the third
quarter of 2014. For the nine months ended September 30, 2015, the net loss was $78.1 million, or $0.30 per share, compared to
a net loss of $51.4 million, or $0.23 per share, for the same period in 2014.
Novavax revenue in the third quarter of
2015 decreased 21% to $6.5 million, compared to $8.2 million for the same period in 2014. This decrease results from a lower level
of development activities under the HHS BARDA contract in the third quarter of 2015 as compared to the same period in 2014.
The cost of government contracts revenue
in the third quarter of 2015 decreased 32% to $2.7 million, compared to $4.0 million for the same period in 2014. The decrease
in cost of government contracts revenue was associated with a lower level of development activities under the HHS BARDA contract
in the third quarter of 2015 as compared to the same period in 2014.
Research and development expenses increased
45% to $27.9 million in the third quarter of 2015, compared to $19.2 million for the same period in 2014. The increase in research
and development expenses was driven by activities relating to the RSV Vaccine and higher employee-related expenses, including
non-cash stock-based compensation, tied to the continued growth of the company.
General and administrative expenses increased
90% to $9.1 million in the third quarter of 2015, compared to $4.8 million for the same period in 2014. The increase in general
and administrative expenses resulted from increased employee-related expenses, including non-cash stock-based compensation, tied
to the continued growth of the company and professional fees for pre-commercialization activities.
As of September 30, 2015, the company
had $290.2 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 nine months of 2015 was $71.3 million, compared to $47.2 million for the same period
in 2014. The factors contributing to the change in operating cash usage were primarily due to increased costs relating to our
RSV F Vaccine, Ebola GP Vaccine and higher employee-related expenses, as well as the timing of customer and vendor payments.
Conference Call
Novavax management will host its quarterly
conference call today at 8:00 a.m. EST. 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 11:00 a.m. on November 9, 2015 until midnight November 16, 2015. To access the replay by telephone, dial
855-859-2056 (Domestic) or 404-537-3406 (International) and use passcode 70778771. 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 and our Quarterly Reports on Form
10-Q for the quarters ended March 31, 2015 and June 30, 2015, 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.
###
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
(in thousands, except per share information) |
| |
Three Months Ended | | |
Nine Months Ended | |
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September 30, | | |
September 30, | |
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2015 | | |
2014 | | |
2015 | | |
2014 | |
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(unaudited) | | |
(unaudited) | |
Revenue | |
$ | 6,525 | | |
$ | 8,214 | | |
$ | 30,397 | | |
$ | 23,935 | |
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Costs and expenses: | |
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Cost of government contracts revenue | |
| 2,747 | | |
| 4,027 | | |
| 8,054 | | |
| 12,150 | |
Research and development | |
| 27,917 | | |
| 19,219 | | |
| 78,686 | | |
| 48,940 | |
General and administrative | |
| 9,060 | | |
| 4,757 | | |
| 21,991 | | |
| 14,871 | |
Total costs and expenses | |
| 39,724 | | |
| 28,003 | | |
| 108,731 | | |
| 75,961 | |
Loss from operations | |
| (33,199 | ) | |
| (19,789 | ) | |
| (78,334 | ) | |
| (52,026 | ) |
Interest income (expense), net | |
| 130 | | |
| 81 | | |
| 324 | | |
| 10 | |
Other income (expense) | |
| (51 | ) | |
| (19 | ) | |
| (121 | ) | |
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Realized gains on marketable securities | |
| ― | | |
| ― | | |
| ― | | |
| 615 | |
Net loss | |
$ | (33,120 | ) | |
$ | (19,727 | ) | |
$ | (78,131 | ) | |
$ | (51,401 | ) |
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Basic and diluted net loss per share | |
$ | (0.12 | ) | |
$ | (0.08 | ) | |
$ | (0.30 | ) | |
$ | (0.23 | ) |
Basic and diluted weighted average | |
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number of common shares outstanding | |
| 269,554 | | |
| 238,304 | | |
| 259,703 | | |
| 221,578 | |
SELECTED CONSOLIDATED BALANCE SHEET
DATA
(in thousands)
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September 30, 2015 | | |
December 31,
2014 | |
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(unaudited) | | |
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Cash and cash equivalents | |
$ | 138,144 | | |
$ | 32,335 | |
Marketable securities | |
| 152,042 | | |
| 135,721 | |
Total current assets | |
| 310,102 | | |
| 188,158 | |
Working capital | |
| 285,229 | | |
| 154,042 | |
Total assets | |
| 404,634 | | |
| 276,002 | |
Total notes payable and capital lease obligation | |
| 664 | | |
| 1,173 | |
Total stockholders’ equity | |
| 367,016 | | |
| 229,618 | |
Contact:
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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