-----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, J5mJTcj+wUYQDoQoqQ+E0Zeu6AFZJHJ8LyjDplRhnYpP+mOuxegL6OA4On2wZuVz 5REbsvBKudLXcTZ5Cs20SQ== 0001144204-10-041745.txt : 20100806 0001144204-10-041745.hdr.sgml : 20100806 20100806081526 ACCESSION NUMBER: 0001144204-10-041745 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20100806 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100806 DATE AS OF CHANGE: 20100806 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: 10996344 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 v192705_8k.htm Unassociated Document
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) August 6, 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 August 6, 2010, Novavax, Inc. (the “Company”) announced its financial results for the second quarter ended June 30, 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.
 
The Company issued a press release announcing its financial results on August 6, 2010.  A copy of the press release is filed with this report as Exhibit 99.1.
 
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On August 6, 2010, the Board of Directors of the Company elected Richard H. Douglas, Ph.D. as a Class II director, effective immediately.  Dr. Douglas is an independent director, as defined by the NASDAQ Listing Rules.  Dr. Douglas was not elected pursuant to any arrangement or understanding between him and any other person and has not been appointed to serve on any committees of the Board of Directors at this time.
 
The Company issued a press release announcing the election of Dr. Douglas on August 6, 2010.  A copy of that press release is filed with this report as Exhibit 99.2.
 
The information furnished in this Current Report on Form 8-K and Exhibits 99.1  and 99.2 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. related to Earnings on August 6, 2010
 
 
99.2
Press release issued by Novavax, Inc. related to Dr. Douglas on August 6, 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)
       
August 6, 2010
     
By:
 
/s/ John A. Herrmann III                                                
           
Name:
 
John A. Herrmann III
           
Title:
 
Executive Director, Legal Affairs and Corporate Secretary
                 
 
 
 

 
EX-99.1 2 v192705_ex99-1.htm Unassociated Document

Contact: 
Frederick W. Driscoll
VP, Chief Financial Officer and Treasurer
Novavax, Inc.
1-240-268-2000


NOVAVAX REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS

Rockville, MD – August 6, 2010 – Novavax, Inc. (NASDAQ: NVAX) today announced financial results for the second quarter ended June 30, 2010.

Novavax reported a net loss of $9.4 million, or $0.09 per share, for the second quarter of 2010 compared to a net loss of $8.5 million, or $0.10 per share, for the second quarter of 2009.  For the six months ended June 30, 2010, the net loss was $20.8 million, or $0.21 per share, compared to a net loss of $16.9 million, or $0.22 per share, for the same period in 2009.  The primary reason for the increased loss for the second quarter of 2010 as compared to the same period in 2009 was higher research and development spending to support the company’s clinical trials related to its H1N1 and seasonal influenza vaccine candidates, as well as increased general and administrative expenses relating to employee costs.  Research and development expenses for the second quarter of 2010 were $6.3 million as compared to $5.3 million in the same period in 2009.  General and administrative expenses were $3.1 million for the second quarter of 2010 as compared to $2.6 million in the same period in 2009.

As of June 30, 2010, the company had $26.8 million in cash, cash equivalents and short-term investments compared to $43.0 million as of December 31, 2009.
 
“Our financial results reflect the continued investment in Novavax’s vaccine candidates and prudent management of our financial and human resources,” said Dr. Rahul Singhvi, President and CEO of Novavax.  “In addition to advancing our clinical programs, we are contending for a potentially significant vaccine development contract with the U.S. government, we have hired outstanding new executives to guide our clinical, pre-clinical and discovery programs, and we have fortified our patent portfolio.”

Recent Accomplishments
Novavax recently reported the following corporate developments:

 
·
Receipt of notification from HHS/BARDA that a potential influenza vaccine development contract is in the “competitive range”;
 
·
Achievement of positive results from trial of trivalent seasonal influenza vaccine in older adults;
 
 
 

 
 
 
·
Recruitment of new Chief Medical and Chief Scientific Officers and appointment of new Head of Process and Manufacturing Operations and Head of Analytical and Quality Operations;
 
·
Continued R&D progress in discovery of new targets to broaden vaccine pipeline;
 
·
Appointment of Dr. James Young, an accomplished and distinguished member of the biotech industry, to the Board of Directors;
 
·
Completion of construction of vaccine production facility in India by joint-venture company, CPL Biologicals; and
 
·
Receipt of key technology patent covering production of VLP vaccines from multiple strains of seasonal and pandemic influenza viruses.

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 on 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 pm through August 8, 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 89793634.

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.
 
 
 

 

Cautionary Note Regarding Forward-Looking Statements
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 our assessment of the results of our clinical trials and our patent coverage on VLP vaccines, are forward-looking statements.  Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time.  We caution readers not to place significant reliance on the forward-looking statements contained in this release.  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 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 and our ability 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 contracts/grants, including from 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, including the factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009, as updated by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.  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)
(unaudited)

   
Three Months Ended
   
Six Months Ended
 
   
June 30,
   
June 30,
 
   
2010
   
2009
   
2010
   
2009
 
             
Revenue
  $ 7     $ 29     $ 117     $ 50  
                                 
Operating expenses:
                               
Research and development
    6,327       5,297       15,356       9,563  
General and administrative
    3,148       2,562       5,683       5,454  
Total operating expenses
    9,475       7,859       21,039       15,017  
Loss from continuing operations
    (9,468 )     (7,830 )     (20,922 )     (14,967 )
Interest income (expense), net
    42       (251 )     84       (584 )
Impairment of short-term investments
          (459 )           (1,338 )
Net loss
  $ (9,426 )   $ (8,540 )   $ (20,838 )   $ (16,889 )
                                 
Basic and diluted net loss per share
  $ (0.09 )   $ (0.10 )   $ (0.21 )   $ (0.22 )
Basic and diluted weighted average
                               
number of common shares outstanding
    100,694       84,832       100,442       76,807  
 
SELECTED BALANCE SHEET DATA
(in thousands)

   
June 30,
2010
   
December 31, 2009
 
   
(unaudited)
       
Cash and cash equivalents
  $ 9,446     $ 38,757  
Short-term investments
    17,340       4,193  
Total current assets
    27,594       44,503  
Working capital
    19,071       36,476  
Total assets
    68,945       85,605  
Total notes payable
    440       486  
Total stockholders’ equity
    57,523       74,465  


# # #
 
 
 

 
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Contact: 
Frederick W. Driscoll
VP, Chief Financial Officer and Treasurer
Novavax, Inc.
1-240-268-2000

NOVAVAX Elects Richard H. Douglas to its Board of Directors

Rockville, MD – August 6, 2010 – Novavax, Inc. (Nasdaq: NVAX) announced today the appointment of Richard Douglas, Ph.D. to its board of directors.  Dr. Douglas is currently Senior Vice President, Corporate Development at Genzyme Corp.  As a leader of Genzyme’s Corporate Development team, Dr. Douglas has been involved in numerous acquisitions, licenses, joint ventures and strategic alliances as well as Genzyme’s venture investments.  He has served in a variety of corporate and product development positions with Genzyme since he joined Integrated Genetics (now Genzyme) as a staff scientist in 1982.

Novavax Chairman Stanley Erck stated:  “Richard has more than twenty-five years of corporate, business and product development experience at Genzyme which will be extremely valuable to Novavax as we advance our vaccine candidates.  His expertise in business development, technology assessment and protein chemistry will be especially helpful in guiding our future discovery, development and commercialization programs.  We welcome his counsel and contributions to our future success.”

Dr. Douglas currently serves on the national advisory board of the University of Michigan Technology Transfer Office and previously served as a director of Iomai Corporation and Synthon Chiragenics.  He received his doctorate in biochemistry from the University of California at Berkeley and his bachelor’s degree in chemistry from the University of Michigan.

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.
 
 
 

 

Cautionary Note Regarding Forward-Looking Statements
Statements herein relating to future performance, conditions or strategies and other matters, including expectations regarding the development of the Company’s vaccines, are forward-looking statements.  Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time.  We caution readers not to place significant reliance on the forward-looking statements contained in this release.  Factors that may cause actual results to differ materially from the results discussed in forward-looking statements or historical experience include, among other things, the following including the Company’s ability to progress its product candidates in preclinical or clinical trials; clinical trial results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; the rate and progress of manufacturing scale-up; and the Company’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise, 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, including the factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009, as updated by our Quarterly Report on Form 10-Q for the quarters ended March 31, 2010.  These forward-looking statements speak only as of the date of this earnings release and Novavax assumes no duty to update such statements.
 
 
 

 
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