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): May 7, 2015
NOVAVAX, INC.
(Exact name of registrant as specified
in charter)
Delaware |
0-26770 |
22-2816046 |
(State or Other Jurisdiction
of Incorporation)
|
(Commission File Number) |
(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.
First Quarter Financial Results
On May 7, 2015,
Novavax, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter
ended March 31, 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.
Exhibit
No. |
|
Description |
|
|
|
99.1 |
|
Press release, dated May 7, 2015, regarding the Company’s financial results for the quarter ended March 31, 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.
|
Novavax, Inc. (Registrant) |
|
|
|
Date: May 8, 2015 |
By: |
/s/ John A. Herrmann III |
|
Name: |
John A. Herrmann III |
|
Title: |
Senior Vice President, General Counsel and Corporate Secretary |
EXHIBIT INDEX
Exhibit
No. |
|
Description |
|
|
|
99.1 |
|
Press release, dated May 7, 2015, regarding the Company’s financial results for the quarter ended March 31, 2015. |
Exhibit 99.1
Novavax Reports First Quarter 2015 Financial
Results
Gaithersburg, Md., May 7, 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 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: |
| o | Phase 2 clinical trial of the RSV
F Vaccine in elderly adults; |
| o | Phase 2 clinical trial of the RSV
F Vaccine in Phase 2 study to protect infants via maternal immunization; |
| o | Phase 2 clinical trial of the Quadrivalent
Seasonal Influenza VLP; and |
| | |
| o | 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 | |
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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