-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WA/dZVaHbjetM4UQxXZFK6fMXMluW70EqAkf5oi06GvfTf5Rio5b3Bkxt9pjCoDD jjzIp3Q8I1qknjFl00ioWQ== 0001144204-10-025549.txt : 20100510 0001144204-10-025549.hdr.sgml : 20100510 20100510092852 ACCESSION NUMBER: 0001144204-10-025549 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100510 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100510 DATE AS OF CHANGE: 20100510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVAVAX INC CENTRAL INDEX KEY: 0001000694 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 222816046 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26770 FILM NUMBER: 10814426 BUSINESS ADDRESS: STREET 1: 9920 BELWARD CAMPUS DRIVE CITY: ROCKVILLE STATE: MD ZIP: 20850 BUSINESS PHONE: 240-268-2000 MAIL ADDRESS: STREET 1: 9920 BELWARD CAMPUS DRIVE CITY: ROCKVILLE STATE: MD ZIP: 20850 8-K 1 v183734_8k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 10, 2010
 
NOVAVAX, INC.
 

(Exact name of Registrant as specified in its charter)
 
Delaware
 
0-26770
 
22-2816046
(State or other jurisdiction of incorporation or organization)
 
(Commission File Number)
 
(I.R.S. Employer Identification No.)
 
9920 Belward Campus Drive
Rockville, Maryland
 
20850
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code:
 
(240) 268-2000
 

(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):
 
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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.

On May 10, 2010, Novavax, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2010 and will conduct a previously announced, publicly available conference call to discuss those results as well as to provide an update on the status of the Company's business operations.
 
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.  The information furnished in this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
 
Item 9.01.  Financial Statements and Exhibits.
 
 
(d) 
Exhibits
 
Exhibits
 
 
99.1
Press release issued by Novavax, Inc. on May 10, 2010
 
 
 

 
 
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, thereunto duly authorized

       
Novavax, Inc.
(Registrant)
 
         
May 10, 2010
     
By:
 
/s/ John A. Herrmann III                                                           
 
           
Name:
 
John A. Herrmann III
 
           
Title:
 
Executive Director, Legal Affairs and Corporate Secretary
 


 
 

 
 
EX-99.1 2 v183734_ex99-1.htm Unassociated Document
Exhibit 99.1
 
ROCKVILLE, Md., May 10 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq:NVAX - - News) today announced financial results for the first quarter ended March 31, 2010.
 
Novavax reported a net loss of $11.4 million, or $0.11 per share, for the first quarter of 2010 compared to a net loss of $8.3 million, or $0.12 per share, for the first quarter of 2009.  The primary reason for the increased loss for the first quarter of 2010 as compared to the same period in 2009 was due to higher research and development spending to support the company's clinical trials related to its seasonal and H1N1 influenza vaccine candidates. Research and development expenses for the first quarter of 2010 increased by $4.7 million to $9.0 million as compared to $4.3 million in the same period in 2009.  General and administrative expenses for the first quarter of 2010 decreased by $0.4 million to $2.5 million as compared to $2.9 million in the same period in 2009.  
 
As of March 31, 2010, the company had $32.9 million in cash, cash equivalents and short-term investments compared to $43.0 million as of December 31, 2009.  
 
"Our first quarter financial results reflect the continued progress of our clinical programs, the achievement of positive findings from our seasonal and H1N1 influenza programs and preparations for clinical testing of our respiratory syncytial virus (RSV) vaccine candidate later this year," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax.  "The recent appointment of Dr. Jim Young to our Board of Directors will be a tremendous advantage to Novavax as the company moves forward to advance our pipeline products. In addition, the determination by the U.S. Department of Health and Human Services (HHS) that we are in the competitive range for consideration of our proposal to develop advanced recombinant influenza vaccines for BARDA is an encouraging sign of support for our technology among public health officials.  As a result of these accomplishments, we are now preparing to seek approval to begin clinical testing of our RSV vaccine candidate, report the results of our recent studies at upcoming medical meetings, continue to pursue registration of our H1N1 influenza vaccine in Mexico and discuss our BARDA proposal with HHS representatives."
 
First Quarter 2010 Accomplishments
 
Novavax recently reported the following product and corporate developments:
 
·  
Report of positive results from 1,000-subject first stage of H1N1 influenza vaccine trial in Mexico;
 
·  
Completion of enrollment of more than 3,500 subjects in second stage of H1N1 influenza vaccine trial in Mexico;
 
·  
Report of additional positive results from trial of trivalent seasonal influenza vaccine in healthy adults;
 
·  
Report of positive pre-clinical results for the company's vaccine candidate to prevent RSV; and
 
·  
Election of Stanley C. Erck as Executive Chairman of the Board of Directors and appointment of Dr. James Young, former President of Research and Development at MedImmune, as an independent Board member.
 
These developments are described more fully in press releases available on the company's website, www.novavax.com.  
 
 
 

 
 
Conference Call
 
Novavax's management will host its quarterly conference call at 10:00 a.m. Eastern time today.  The live conference call will be accessible via Novavax's website at www.novavax.com under "Investor/Events" or by telephone at 1-877-212-6076 (domestic) or 1-707-287-9331 (international). A replay of the webcast will be available on the Novavax website for 90 days after the call and a replay of the conference call will be available beginning today at 1:00 p.m. through May 15, 2010 until 11:59 p.m. Eastern time.  To access the replay of the conference call, dial 1-800-642-1687 (domestic) or 1-706-645-9291 (international) and enter pass code 72997898.
 
About Novavax
 
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.
 
Safe-Harbor Statement
 
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding revenue, operating expenses, use of cash, and clinical developments and anticipated milestones, including a BARDA contract, and efforts to get regulatory approval in the country of Mexico, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act.  Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include, among other things, the following: our ability to progress any product candidates into pre-clinical studies or clinical trials; the scope, initiation, rate and progress of our pre-clinical studies and clinical trials and other research and development activities; clinical trial results; even with positive data from pre-clinical studies or clinical trials, the product candidate may not prove to be safe and efficacious; regulatory approval is needed before any vaccines can be sold in or outside the United States and, to date, no governmental authority has approved any of our vaccine candidates for sale; influenza is seasonal in nature, and if approval or commercial launch after approval is not timely in relation to the influenza season, we may not be able to manufacture or sell our influenza vaccines on terms favorable to us until the next influenza season, if at all; we have not manufactured any of our vaccine candidates at a commercial level; we utilize a unique manufacturing process and the scale-up of that process may prove difficult and/or costly; our dependence on third parties to manufacture and distribute our vaccines; risks associated with conducting business outside of the United States; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; our ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration; our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; the inability to win any government grants, including BARDA, in a timely manner or if at all and other factors referenced herein.  Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.  These forward-looking statements speak only as of the date of this earnings release and Novavax assumes no duty to update such statements.
 
 
 

 
 
 
NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(in thousands, except per share information)
 
   
Three Months Ended
 
   
March 31,
 
   
2010
   
2009
 
   
(unaudited)
 
Revenue
  $      110     $       21  
                 
Operating expenses:
               
Research and development
    9,029       4,266  
General and administrative
    2,535       2,892  
Total operating expenses
    11,564       7,158  
Loss from continuing operations
    (11,454 )     (7,137 )
Interest income (expense), net
    42       (333 )
Impairment of short-term investments
    -       (879 )
Net loss
  $ (11,412 )   $ (8,349 )
                 
Basic and diluted net loss per share
  $   (0.11 )   $  (0.12 )
Basic and diluted weighted average
               
number of common shares outstanding
    100,188       68,692  
                 
 
 
 
 

 
 
SELECTED BALANCE SHEET DATA
(in thousands)
 
   
March 31,  2010
   
December 31, 2009
 
   
(unaudited)
       
Cash and cash equivalents
  $ 14,575     $ 38,757  
Short-term investments
    18,313       4,193  
Total current assets
    33,817       44,503  
Working capital
    24,584       36,476  
Total assets
    75,377       85,605  
Total notes payable
    460       486  
Total stockholders' equity
    63,139       74,465  

 
 

 
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