-----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, Sb2PO/bL7MNs0Ren8dJMQ4R9q4fDtrhSbO91LPgiyVZcjyGSmxc0oQbf8q4ED6RB tT/zxLGvT0lXqweVRpVRhg== 0001299933-06-001371.txt : 20060301 0001299933-06-001371.hdr.sgml : 20060301 20060301144253 ACCESSION NUMBER: 0001299933-06-001371 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060301 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060301 DATE AS OF CHANGE: 20060301 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: 06654900 BUSINESS ADDRESS: STREET 1: 508 LAPP ROAD CITY: MALVERN STATE: PA ZIP: 19355 BUSINESS PHONE: 4849131200 MAIL ADDRESS: STREET 1: 508 LAPP ROAD CITY: MALVERN STATE: PA ZIP: 19355 8-K 1 htm_10634.htm LIVE FILING Novavax, Inc. (Form: 8-K)  

 


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):   March 1, 2006

Novavax, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 0-26770 22-2816046
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
508 Lapp Road, Malvern, Pennsylvania   19355
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   484-913-1200

Not Applicable
______________________________________________
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:

[  ]  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.

On March 1, 2006, the Company issued a news release announcing its financial results for the quarter and year ended December 31, 2005, which also referenced a conference call to discuss these results and provide an update on the status of the Company's programs. A copy of the news release is furnished as exhibit 99.1 hereto and is incorporated by reference to Item 9.01 of Form 8-K.





Item 9.01 Financial Statements and Exhibits.






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.
          
March 1, 2006   By:   Dennis W. Genge
       
        Name: Dennis W. Genge
        Title: Vice President and Chief Financial Officer


Exhibit Index


     
Exhibit No.   Description

 
99.1
  Press release dated March 1, 2006 entitled "Novavax Announces Fourth Quarter and Year-End 2005 Financial Results."
EX-99.1 2 exhibit1.htm EX-99.1 EX-99.1

FOR IMMEDIATE RELEASE NASDAQ symbol: NVAX

NOVAVAX ANNOUNCES
FOURTH QUARTER AND YEAR–END 2005 FINANCIAL RESULTS

MALVERN, PA., March 1, 2006 – Novavax, Inc. (NASDAQ: NVAX) today announced its fourth quarter and year–end 2005 financial results.

Recent Significant Events at Novavax include:

    Completed $38.0 million in equity capital raises at $4.30-$4.35 per share (November 2005/February 2006)

      – Total of $42.0 million of new equity capital raised within last twelve months

    Completed License Agreement on ESTRASORB® with Esprit Pharma Inc. for North American distribution (October 2005)

      – Minimum $12.5 million in mandatory payments over twelve months (received $10.0 million in 2005 and $2.5 million due in October 2006)

     

  Double digit royalty on all ESTRASORB sales
Significant future milestone payments

      – Novavax maintains product manufacturing, and international markets outside of North America

    Converted $6.0 million of outstanding convertible notes to equity (October 2005) – Reduced convertible notes outstanding to $29.0 million – Reduced annual interest expense by $285,000

      – Remaining bondholders cannot “Put” remaining convertible notes to the Company until July 2007

    Expanded the Vaccine Initiative

      – Research collaboration initiated with the University of Pittsburgh School of Medicine on efficacy seasonal and pandemic influenza. (February 2006)

      – Formed strategic alliances with Wave Biotech and Pacific GMP on the development of a commercial scale manufacturing and production process for vaccines. (September 2005/February 2006)

      – Formed Special Governmental Relations Committee of the Board. (December 2005)

    Filed a new $100.0 Million Shelf Registration Statement (December 2005)

    Nominated two new experienced Board Members from within the bio-pharmaceutical industry.

Commenting on the fourth quarter and year-end 2005 operating results, Dr. Rahul Singhvi, President and Chief Executive Officer, stated, “Novavax continued its transformation into a new, dynamic company focused on development of new important products in the fourth quarter of 2005. The licensing of North American marketing rights of Estrasorb to Esprit Pharma was critical to our business plan. We assumed a leadership position in addressing the global pandemic influenza threat by leveraging our virus-like particle (VLP), Novasome adjuvants, and portable manufacturing technologies. We now believe we have the necessary financial and human resources to develop a vaccine against H5N1 and other strains of avian and seasonal influenza vaccines and we look forward to reporting our progress on these programs in the near future.”

Fourth Quarter Financial Results

Total revenues for the fourth quarter ended December 31, 2005 were $2.2 million compared with total revenues of $2.0 million for the same period last year. The increase was due to a $1.0 million license payment offset by decreases in product sales due to the sale or license of the Company’s vitamin, AVC and ESTRASORB products in September and October 2005. For the twelve-month periods ended December 31st, in 2005, total revenues were $7.4 million compared with $8.3 million in 2004. Of the total decrease in revenues, product sales accounted for $1.8 million, due to the sales and license of products, partially offset by a $0.9 million increase, in royalties, milestone and licensing fees.

Cost of products sold for the three-month period ended December 31, 2005 was reduced significantly to $717 thousand compared with $1.4 million for the three-month period ended December 31, 2004, primarily due to the sale of the majority of the Company’s product lines. In the three month period ended December 31, 2005 the Company also took a $1.5 million charge to write down ESTRASORB inventory to values which reflected future selling cost. Cost of products sold for the twelve month period, which includes fixed idle capacity costs at our manufacturing facility, increased to $5.8 million in 2005, compared to $3.5 million in 2004, a 66% increase. Of the $5.8 million costs of products sold for 2005, $3.2 million was due to idle plant capacity costs at our manufacturing facility compared to $0.7 million in 2004. The remaining $2.6 million increase was primarily due to ESTRASORB, which accounted for 45% of net product sales in 2005, as compared to 28% of net product sales in 2004.

Research and development costs for the three-month period ended December 31, 2005, were $1.3 million compared to $1.5 million for the three-month period ended December 31, 2004. For the full year research and development costs decreased from $7.4 million in 2004 to $5.1 million in 2005. The decrease of $2.3 million or 31% was due to manufacturing start-up costs in 2004 being accounted for in the research and development category until production began in April 2004. We expect research and development costs to increase in 2006 as we progress on the development of other products in our pipeline, primarily related to vaccine research and development.

Selling and marketing costs were reduced to $89 thousand for the three-month period ended December 31, 2005, compared with $6.3 million for the same period last year. The decrease of $6.2 million was primarily due to the prior investment in the marketing launch of ESTRASORB in 2004, as well as elimination of our sales force over the past year and the decision to discontinue any further marketing efforts solely within our Company. Selling and marketing expenses were $6.9 million for the twelve month period ended December 31, 2005, compared with $23.6 million for the same twelve-month period last year. The $16.7 million decrease was primarily due to the significant marketing investment made in 2004 for the initial launch of ESTRASORB as well as our business strategy of transitioning to our core competency of new product development.

Total general and administrative costs were $2.0 million for the three-month period ended December 31, 2005, compared with $2.7 million for the three-month period ended December 31, 2004. The reduction in general administrative costs during this period of $0.7 million was due to reductions in various categories of expenses, including accounting, consulting, investor relations, and salary expense. Total general and administrative costs were $8.1 million for the twelve-month period ended December 31, 2005, compared with $8.7 million for the similar period in 2004.

In October 2005, the Company entered into License and Supply Agreements for its primary product, ESTRASORB. In consideration for the rights granted, the Company was paid $10.0 million in the fourth quarter of 2005. A minimum amount of another $2.5 million will be paid during the fourth quarter 2006, along with other contingency royalties and milestone payments. As part of this transaction the Company also wrote off $2.2 million which represented the remaining net balance of its intangible asset for ESTRASORB. The Company incurred $0.2 million of fees related to this transaction and recorded a gain of $10.1 million during the fourth quarter of 2005.

For the three-month period ended December 31, 2005, the Company had a net profit of $6.2 million, or $0.13 per share, compared with a net loss of $10.3 million, or ($0.26) per share, for the same three-month period last year. For the twelve-month period ended December 31, 2005, the Company had a net loss of $11.2 million, or ($0.26) per share, compared with a net loss of $25.9 million, or ($0.70) per share for the similar 2004 period.

As of December 31, 2005, the Company had $31.9 million in cash and cash-equivalents compared with $17.9 million at December 31, 2004. The February 2006 equity offering, with gross proceeds of $20.0 million, adds to this year end balance. In November 2005, the Company also completed an equity offering of 4,186,047 shares of common stock at $4.30 per share for gross proceeds of $18.0 million. The equity raised in November 2005 and February 2006 were both issued pursuant to existing “shelf” registration statements.

Conference Call
The Company will hold an investor conference call to discuss its financial results at 10:00 a.m. ET on March 1, 2006. The call will be hosted by Mr. Gary C. Evans, Chairman of the Board and Dr. Rahul Singhvi, President and CEO of Novavax. Other participants on the call will include senior management of Novavax. A question and answer session will follow the financial results overview. The dial in number for the conference call is (866) 356-3093, pass code 67425359.

A live audio webcast and presentation of the conference call will be available through http://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 starting on March 1, 2006 at http://www.novavax.com. A replay of the conference call will also be available by telephone on March 1, 2006 through June 1, 2006. To access the replay, dial (888) 286-8010 and enter pass code 63645862 followed by the number sign.

About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. These include the Company’s virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimer technologies. Novavax, Inc. is also a product development company focused on the research, development and commercialization of new products utilizing its proprietary drug delivery and biological technologies for large and growing markets. Novavax’s drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB. In addition to MNP, Novavax drug delivery technologies include Novasomes® (paucillamellar non-phospholipid liposomes) and Sterisomes® (subcutaneous depot injection).

1

NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)

                                 
    Unaudited    
    Three-months ended   Year ended
    December 31, 2005   December 31, 2004   December 31, 2005   December 31, 2004
Revenues:
                               
Net product sales
  $ 641     $ 2,207     $ 4,549     $ 6,397  
Contract research & development
    562       (161 )     1,798       1,738  
Royalties, milestone and licensing fees
    1,041             1,041       125  
 
                               
Total revenues
    2,244       2,046       7,388       8,260  
 
                               
Operating costs and expenses:
                               
Cost of products sold
    717       1,362       5,791       3,490  
Excess inventory costs over market
    1,519             1,519        
Research and development
    1,315       1,541       5,075       7,369  
Selling and administrative
    89       6,327       6,920       23,588  
General and administrative
    2,005       2,724       8,114       8,716  
Facility exit costs
                105       723  
Gain on sales of product assets
    (10,109 )           (10,965 )      
Gain on redemption of debt
                      (11,162 )
 
                               
Total operating costs and expenses
    (4,464 )     11,954       16,559       32,724  
 
                               
Gain/(Loss) from operations
    6,708       (9,908 )     (9,171 )     (24,464 )
Interest expense, net
    (553 )     (450 )     (2,003 )     (1,526 )
Other income
          70             70  
Net gain/(loss)
  $ 6,155     $ (10,288 )   $ (11,174 )   $ (25,920 )
 
                               
Basic and diluted gain/(loss) per share
  $ 0.13     $ (0.26 )   $ (0.26 )   $ (0.70 )
 
                               
Basic and diluted weighted average number of common shares outstanding
    47,887,656       39,553,876       42,758,302       36,926,034  
 
                               

Selected Balance Sheet Data
(in thousands)

                 
    As of December   As of December 31,
    31, 2005   2004
Cash and cash equivalents
  $ 31,893     $ 17,876  
Total current assets
  $ 37,611     $ 23,937  
Working capital
  $ 32,735     $ 15,361  
Total assets
  $ 84,382     $ 77,993  
Long term obligations
  $ 29,678     $ 35,970  
Stockholders’ equity
  $ 49,652     $ 33,281  

2

Statements made in this press release that state Novavax’s or management’s intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax’s actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax’s annual report on Form 10K for the year ended December 31, 2004 and quarterly reports on Form 10Q for the quarters ended March 31, 2005 ,June 30, 2005 and September 30, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax’s annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at www.sec.gov.

- ### -

For Further Information Contact:
Investor Relations
Kathy Hamilton
Novavax, Inc.
Tel: (484) 913-1213
Email: khamilton@novavax.com

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