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): August 6, 2014
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.
Second Quarter Financial Results
On August 6, 2014,
Novavax, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter
ended June 30, 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 August 6, 2014, regarding the Company’s financial results for the quarter ended June 30, 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.
(Registrant) |
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Date: August 7, 2014 |
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By: |
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/s/ John A. Herrmann III |
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Name: |
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John A. Herrmann III |
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Title: |
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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 August 6, 2014, regarding the Company’s financial results for the quarter ended June 30, 2014. |
Exhibit 99.1
Novavax Reports Second-Quarter 2014 Financial
Results
Gaithersburg, MD (August 6, 2014) -
Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization
of recombinant nanoparticle vaccines and adjuvants, today reported its financial results for the second quarter and six months
ended June 30, 2014.
Novavax Corporate Highlights
Second Quarter Achievements:
| - | Delivered positive top-line data from a dose-confirmatory Phase 2 clinical trial of its RSV F-protein
vaccine candidate in 720 women of childbearing age, including a key finding that the highest levels of Palivizumab-competing antibodies
(PCA) observed in any of its previous trials was achieved with only one dose of its vaccine candidate; |
| - | Reported follow-up data from its dose-ranging Phase 1 clinical trial of its RSV F-protein vaccine
candidate in 220 elderly subjects, showing sustained levels of RSV F antibody and PCA responses were demonstrated over a four to
six month period; and |
| - | Raised total net-proceeds of $108 million, after deducting underwriters discount and offering expenses,
in an underwritten public offering. |
2014 Anticipated Events:
| - | Release of top-line data from recently initiated Phase 1/2 clinical trial of H7N9 avian influenza
VLP vaccine candidate with its Matrix-M adjuvant in the third quarter of 2014; |
| - | Initiate Phase 2 clinical trial of its RSV F-protein vaccine candidate for protection of infants
via maternal immunization in pregnant women in fourth quarter of 2014; |
| - | Initiate Phase 1 clinical trial of its RSV F-protein vaccine candidate for protection of pediatrics
in fourth quarter of 2014; |
| - | Initiate Phase 2 clinical trial of its RSV F-protein vaccine candidate for protection of elderly
in fourth quarter of 2014; |
| - | Initiate Phase 2 clinical trial of its quadrivalent VLP seasonal influenza vaccine in the fourth
quarter of 2014; |
| - | Novavax, Inc. 2014 Analyst and Investor Meeting to be held on Tuesday, September 23, 2014 in New
York City; and |
| - | Novavax will present the following pre-clinical data at the upcoming ICAAC conference to be held
in Washington, DC between September 5 –
9, 2014: |
| o | Presentation # I-649: “Immunization of Pregnant Baboons with the RSV Nanoparticle Vaccine
Protects Infant Baboons Challenged with Respiratory Syncytial Virus in a Comparable Manner to Infants Prophylaxed with Palivizumab;”
and |
| o | Presentation # I-314B: “Development and Characterization of Recombinant RSV Nanoparticle
Vaccine Induced Monoclonal Antibody.” |
“Progress in the second quarter maintained
the momentum built in both the first quarter of the year and in 2013. We continue to make progress in our RSV and influenza vaccine
development programs,” said Stanley C. Erck, President and CEO of Novavax. “The second half of 2014 will be the most
productive period in the company’s history. We plan to initiate 4 clinical studies before the end of 2014; RSV maternal immunization,
pediatric and elderly, as well as a seasonal influenza clinical trial. We also plan to initiate a combination RSV/seasonal influenza
clinical trial in early 2015. In addition, we plan to present pre-clinical and clinical data at several important medical meetings
later this year.”
Financial Results for the Three and
Six Months Ended June 30, 2014
Novavax reported a net loss of $17.9 million,
or $0.08 per share, for the second quarter of 2014, compared to a net loss of $12.6 million, or $0.08 per share, for the second
quarter of 2013. For the six months ended June 30, 2014, the net loss was $31.7 million, or $0.15 per share, compared to a net
loss of $22.6 million, or $0.15 per share, for the same period in 2013.
Novavax revenue in the second quarter of
2014 increased 134% to $8.3 million as compared to $3.5 million for the same period in 2013. The increase in revenue was primarily
due to the higher level of activity in the second quarter of 2014 associated with the company’s Phase 1/2 clinical trial
using its H7N9 pandemic influenza candidate and Matrix-M adjuvant and preliminary manufacturing work for its Phase 2 seasonal influenza
clinical trial, both under the HHS BARDA contract, and with the company’s Phase 2 clinical trial in women of childbearing
age under its amended collaboration with PATH. In conjunction with the increase in revenue, the cost of government contracts revenue
in the second quarter of 2014 increased 213% to $5.1 million as compared to $1.6 million for the same period in 2013. This increase
was primarily related to higher level of activity associated with the company’s previously mentioned pandemic and seasonal
influenza activities.
Research and development expenses increased
41% to $15.2 million in the second quarter of 2014, compared to $10.8 million for the same period in 2013, primarily as a result
of higher employee-related costs tied to continued growth in support of the company’s RSV and influenza vaccine programs,
as well as Novavax AB research and development expenses. General and administrative expenses increased 45% to $5.8 million in the
second quarter of 2014 as compared to $4.0 million for the same period in 2013, resulting from higher employee-related costs, as
well as Novavax AB general and administrative expenses, partially offset by lower professional fees.
As of June 30, 2014, the company had $208.8
million in cash and cash equivalents and investments compared to $133.1 million as of December 31, 2013. In June 2014, the company
raised net proceeds of approximately $108 million through the sale of its common stock. Net cash used in operating activities for
the six months of 2014 was $31.4 million compared to $18.2 million for the same period in 2013. The factors contributing to the
increase in cash usage are as described above.
Conference Call
Date: |
August 6, 2014 |
Time: |
4:30 PM US eastern time |
Dial-in number: |
1 (877) 212-6076 (domestic) or 1 (707) 287-9331 (international) |
Via Web: |
www.novavax.com |
Conference call Replay:
Dates: |
Starting at 6:31 PM on August 6, 2014 until midnight October 6, 2014 |
Dial-in number: |
1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) |
Passcode: |
82216889 |
Via-Web: |
www.novavax.com, “Investor Info”/“Events” |
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage
biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide.
Using innovative proprietary recombinant nanoparticle vaccine technology, the company produces vaccine candidates to efficiently
and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company’s
website, novavax.com.
Novavax Inc., 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, 2013, 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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NOVAVAX, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
(in thousands, except per share information) |
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Three Months Ended | | |
Six Months Ended |
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June 30, | | |
June 30, |
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2014 | | |
2013 | | |
2014 | | |
2013 | |
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(unaudited) | | |
(unaudited) |
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Revenue | |
$ | 8,259 | | |
$ | 3,531 | | |
$ | 15,721 | | |
$ | 7,365 | |
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Costs and expenses: | |
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Cost of government contracts revenue | |
| 5,102 | | |
| 1,632 | | |
| 8,123 | | |
| 3,344 | |
Research and development | |
| 15,202 | | |
| 10,785 | | |
| 29,720 | | |
| 20,041 | |
General and administrative | |
| 5,806 | | |
| 4,012 | | |
| 10,114 | | |
| 6,882 | |
Total costs and expenses | |
| 26,110 | | |
| 16,429 | | |
| 47,957 | | |
| 30,267 | |
Loss from operations | |
| (17,851 | ) | |
| (12,898 | ) | |
| (32,236 | ) | |
| (22,902 | ) |
Interest income (expense), net | |
| (31 | ) | |
| 3 | | |
| (71 | ) | |
| 27 | |
Other income | |
| 18 | | |
| ― | | |
| 18 | | |
| ― | |
Change in fair value of warrant liability | |
| ― | | |
| 267 | | |
| ― | | |
| 267 | |
Realized gains on investments | |
| ― | | |
| ― | | |
| 615 | | |
| ― | |
Loss from operations before income tax expense | |
| (17,864 | ) | |
| (12,628 | ) | |
| (31,674 | ) | |
| (22,608 | ) |
Income tax expense | |
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| 5 | | |
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| 22 | |
Net loss | |
$ | (17,864 | ) | |
$ | (12,633 | ) | |
$ | (31,674 | ) | |
$ | (22,630 | ) |
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Basic and diluted net loss per share | |
$ | (0.08 | ) | |
$ | (0.08 | ) | |
$ | (0.15 | ) | |
$ | (0.15 | ) |
Basic and diluted weighted average | |
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number of common shares outstanding | |
| 217,178 | | |
| 152,312 | | |
| 213,075 | | |
| 150,391 | |
SELECTED CONSOLIDATED BALANCE SHEET
DATA
(in thousands)
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June 30, 2014 | | |
December 31,
2013 | |
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(unaudited) | | |
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Cash and cash equivalents | |
$ | 103,857 | | |
$ | 119,471 | |
Investments | |
| 104,951 | | |
| 13,597 | |
Total current assets | |
| 166,602 | | |
| 145,001 | |
Working capital | |
| 149,123 | | |
| 126,879 | |
Total assets | |
| 311,991 | | |
| 235,125 | |
Total notes payable and capital lease obligations | |
| 1,808 | | |
| 2,184 | |
Total stockholders’ equity | |
| 281,731 | | |
| 203,234 | |
###
| Contact: | Barclay A. Phillips |
| | SVP, Chief Financial Officer and Treasurer |
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