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NOVAVAX Reports Second Quarter 2010 Financial Results

ROCKVILLE, Md., Aug 06, 2010 /PRNewswire via COMTEX/ --

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,

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 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:

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, 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.
             (in thousands, except per share information)

                                                    Six Months
                         Three Months Ended                        Ended
                              June 30,              June 30,
                              --------              --------
                           2010         2009      2010          2009
                           ----         ----      ----          ----

    Revenue                  $7          $29      $117           $50
                            ---          ---      ----           ---

      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
     operations          (9,468)      (7,830)  (20,922)      (14,967)
    Interest income
     (expense), net          42         (251)       84          (584)
    Impairment of
     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
       outstanding      100,694       84,832   100,442        76,807
                        =======       ======   =======        ======

                     SELECTED BALANCE SHEET DATA
                           (in thousands)

                                             June 30,            31,
                                                   2010            2009
                                                   ----             ---
     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

SOURCE Novavax, Inc.

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