-----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, PY4+5LP7M+bD98Y+GOz73vfdyYGTwG+zVPJvGKQ9sTrRFmwBwKtKzCbN26+v6Py2 lgzBRJ8xpR5GknyKBqZkWA== 0000950133-07-004583.txt : 20071109 0000950133-07-004583.hdr.sgml : 20071109 20071109171419 ACCESSION NUMBER: 0000950133-07-004583 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071109 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071109 DATE AS OF CHANGE: 20071109 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: 071232846 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 w42476e8vk.htm 8-K e8vk
 

 
 
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) November 9, 2007
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 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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 November 12, 2007, Novavax, Inc. (the “Company”) will issue a press release announcing its financial results for the third quarter ended September 30, 2007 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 to be issued by Novavax, Inc. on November 12, 2007

2


 

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)
 
 
November 9, 2007  By:   /s/ Len Stigliano   
 
  Name:   Len Stigliano   
  Title:   Vice President, Treasurer and Chief
Financial Officer 
 
 

3

EX-99.1 2 w42476exv99w1.htm EX-99.1 exv99w1
 

Exhibit 99.1
(NOVAVAX LOGO)
Contact:   Tricia J. Richardson
Novavax, Inc.
240-268-2031
NOVAVAX REPORTS THIRD QUARTER 2007 FINANCIAL RESULTS AND PROGRESS
WITH VACCINE DEVELOPMENT PROGRAMS
ROCKVILLE, MD (November 12, 2007) — /PRNewswire-FirstCall/ — Novavax Inc. (NASDAQ: NVAX) today reported financial results for the third quarter ended September 30, 2007 and reviewed its recent accomplishments and upcoming milestones. Novavax reported a net loss of $9.0 million, or the equivalent of $0.15 loss per share, compared with a $5.0 million net loss, or the equivalent of $0.08 loss per share in the third quarter of 2006.
For the nine months ended September 30, 2007, the Company reported a net loss of $25.5 million or $0.42 loss per share, as compared to a loss of $16.9 million or $0.29 loss per share for the nine months ended September 30, 2006. The increase in net loss was principally due to increases in research and development costs related to advancing the Company’s two lead virus-like particle (“VLP”)-based vaccine candidates against pandemic and seasonal influenza.
“Financial results for the third quarter and year to date were in line with our expectations and reflect our continued progress across all of our drug development activities, particularly with our two flu vaccine programs. With the initiation of human clinical trials for H5N1 pandemic flu VLP vaccine, we are now a clinical-stage vaccine company and on target to announce scheduled top line results from this Phase I/IIa trial in December 2007,” said Novavax President and Chief Executive Officer, Dr. Rahul Singhvi.
Key recent accomplishments were as follows:
    Enrolled all seventy stage ‘A’ participants in the Phase I/IIa clinical trial of our novel pandemic vaccine from which scheduled top line results will be reported in December. The first subject was enrolled in this study in July.
 
    Advanced our trivalent seasonal flu vaccine program into preclinical studies. This program is on target for an IND filing in the second quarter of 2008.
 
    Announced a new vaccine candidate for the prevention of Shingles caused by the Varicella Zoster Virus, expanding our vaccine product pipeline to three.
 
    Continued progress in building a GMP pilot-plant facility at our Rockville, Maryland headquarters to allow manufacturing of Phase I-III clinical supplies of our VLP vaccine candidates.
 
    Announced in conjunction with Allergan the wind down of manufacturing of the production of Estrasorb ®. Estrasorb ® was acquired by Allergan as a result of their acquisition of Esprit Pharma in October 2007.
Some of the key milestones anticipated during the fourth quarter of 2007 are:
    The announcement of a fourth vaccine candidate.
 
    Pre-clinical results for our trivalent seasonal flu VLP vaccine candidate.

 


 

    Completion of construction of our GMP pilot manufacturing facility for production of our VLP vaccine candidates.
 
    Scheduled results from our Phase I/IIa H5N1 pandemic flu vaccine trial.
Third Quarter Financial Results
Revenues for the third quarter ended September 30, 2007 were $1.3 million, an increase of $0.1 million over the $1.2 million reported in the comparable 2006 period. Revenues consist of ESTRASORB® sales and royalties paid by Esprit Pharma, Inc. of $0.5 million as well as contract research and development revenues of $0.7 million in the third quarter of 2007 as compared to $0.6 million of research and development revenues for the same period in 2006.
Cost of products sold for the three-month period ended September 30, 2007 was $1.1 million as compared to $1.2 million for the same period in 2006. Included in the cost of products sold was $0.6 million in idle capacity costs at our manufacturing facility compared to $0.7 million of such costs in the comparable 2006 quarter. The company also incurred $0.8 million in excess inventory costs over market for the third quarter as compared to $0.3 million in the comparable 2006 period, which reflects its current production costs over the sales transfer price of ESTRASORB®.
Research and development costs for the third quarter increased to $5.6 million compared to $2.9 million for the comparable 2006 three-month period. The increase in R&D was primarily due to higher spending to support the continuing development of the Company’s influenza vaccines as well as licensing fees paid to Wyeth Holdings as a result of a licensing agreement signed in July 2007.
General and administrative expenses were $3.1 million for the third quarter of 2007, as compared to $2.6 million for the same period last year. The increase in expenses was principally due to increased facility expenses of $0.4 million resulting from the new leased facility in Rockville, Maryland.
As of September 30, 2007, Novavax had $52.3 million in cash, cash-equivalents, and short-term investments as compared to $73.6 million at December 31, 2006, a decrease of $21.3 million. The decrease of $21.3 million was principally due to operating losses incurred for the year to date period of 2007, partially offset by non-cash expenses of $3.4 million.
Conference Call
The Company will hold an investor conference call at 10:00 a.m. Eastern Time on November 12, 2007 to discuss its financial results. The call will be hosted by Novavax President and Chief Executive Officer Dr. Rahul Singhvi and other members of senior management. The dial-in number for the conference call in the United States and Canada is (800) 810 0924; international callers may dial (913) 981 4900.
A live audio webcast of the conference call will be available at www.novavax.com. Please connect to this website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. A replay of the webcast will be available for 90 days after the webcast and a replay of the conference call will also be available by telephone beginning 1pm EST. November 12, 2007 through midnight November 19, 2007. To access the replay, dial (888) 203 1112 and enter pass code 5883744.
About Novavax
Novavax Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company’s

 


 

proprietary virus-like particle (VLP) and Novasome® adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax’s particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs. Additional information about Novavax is available at www.novavax.com and in the company’s various filings with the Securities and Exchange Commission.
Forward Looking Statements
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding product sales, operating expenses, and clinical developments 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 risks and uncertainties, including the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax’s product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Novavax’s proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. 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 http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

 


 

NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
(unaudited)
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
    2007     2006     2007     2006  
Revenues:
                               
Net product sales
  $ 453     $ 571     $ 678     $ 1,668  
Contract research and development
    710       582       1,146       1,459  
Royalties and milestone fees
    152       40       318       208  
 
                       
 
                               
Total revenues
    1,315       1,193       2,142       3,335  
 
                       
 
                               
Operating costs and expenses:
                               
Cost of products sold
    1,096       1,170       3,269       3,564  
Excess inventory costs over market
    757       264       1,317       1,256  
Research and development
    5,634       2,903       13,487       8,336  
General and administrative
    3,085       2,550       11,044       7,946  
 
                       
 
                               
Total operating costs and expenses
    10,572       6,887       29,117       21,102  
 
                       
 
                               
Loss from operations
    (9,257 )     (5,694 )     (26,975 )     (17,767 )
 
                       
 
                               
Other income (expense)
                               
Interest income
    749       1,021       2,559       2,239  
Interest expense
    (458 )     (341 )     (1,132 )     (1,392 )
 
                       
 
                               
Net loss
  $ (8,966 )   $ (5,014 )   $ (25,548 )   $ (16,920 )
 
                       
 
                               
Basic and diluted loss per share
  $ (0.15 )   $ (0.08 )   $ (0.42 )   $ (0.29 )
 
                       
 
                               
Basic and diluted weighted average number of common shares outstanding
    61,399,445       61,500,942       61,311,478       58,444,933  
 
                       
                 
    As of September 30,     As of December 31,  
    2007     2006  
 
               
Cash, cash equivalents and short-term investments
  $ 52,260     $ 73,595  
Total current assets
    55,317       77,342  
Total assets
    99,706       121,877  
Working capital
    49,700       72,003  
Long term debt
    21,817       22,458  
Stockholders’ equity
    71,883       94,001  
###

 

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