Novavax, Inc. News
Novavax Reports First Quarter 2008 Financial Results
The following are key achievements during the quarter as well as additional plans for the balance of the year:
— Commenced Phase IIa clinical studies for its H5N1 pandemic influenza vaccine as a continuation of the original Phase I/IIa trial which started last year. An interim analysis in December 2007 was favorable, indicating that this vaccine demonstrated immunogenicity at 15 microgram and 45 microgram dose levels and was well tolerated. The Company remains on plan to report preliminary immunogenicity results from the dose-ranging portion of this Phase IIa study in late third quarter/early fourth quarter of 2008. — Continued as planned to advance its seasonal influenza vaccine program through pre-clinical studies with a target of commencing human trials in a Phase IIa study in early third quarter of 2008. The Company believes the initial results from the pandemic influenza vaccine study bode well for the seasonal program. It is important to note the safety data generated in the ongoing Phase I/IIa H5N1 pandemic influenza study will be used to support the safety database for our seasonal program which will allow us to begin human trials for this program with a Phase IIa trial. — Pending a successful outcome of the Phase IIa trial, an additional Phase IIb trial of our seasonal influenza vaccine program is planned in older adult subjects commencing in the fourth quarter of 2008. The intent of this head-to-head trial is to evaluate the immunogenicity of the seasonal influenza VLP vaccine candidate as compared with that of an approved, marketed vaccine in the older adult population. — Continued to advance two additional new vaccine discovery programs, one for Varicella Zoster (Shingles) and a second for an undisclosed disease target with the goal of progressing both of these candidates through proof of concept animal studies during the next two quarters. — Enhanced VLP technology capabilities by developing a new approach in creating VLPs that expands our ability to apply VLPs to a broader number of potential vaccine disease targets. — Announced the completion of construction for our GMP pilot plant in the Company's Rockville, Maryland headquarters with a ribbon cutting ceremony held on May 1, 2008. This facility will showcase the capability of our ready to use and disposable production technology in a relatively low cost environment. — Progressed the collaboration with GE Healthcare to develop and market a pandemic influenza vaccine manufacturing solution for selected international countries. — Completed the sale of assets related to Estrasorb in the United States, Canada and Mexico to Graceway Pharmaceuticals, LLC (\"Graceway\") in February 2008. As part of that sale, Novavax entered into a supply agreement with Graceway which requires the Company to manufacture additional units of Estrasorb, with final delivery expected in mid- 2008.
"We continue to make solid progress in our clinical development programs and currently are on track to achieve our plans for 2008," said Novavax Chief Executive Officer Dr.
2008 Financial Results
Revenue from continuing operations, for the first quarter ended
There were no costs of products sold from continuing operations in the first quarter of 2008 due to the classification of Estrasorb manufacturing into discontinued operations, as compared to
Research and development costs for the first quarter of 2008 were
General and administrative costs were
As a result, total losses from continuing operations before interest income (net) was
Interest income, net of interest expense was
Accordingly, the loss from continuing operations was
Losses from discontinued operations are a result of the Company's decision to discontinue manufacturing of Estrasorb as of
The total net loss when combining the loss from continuing and discontinued operations was
As of
Conference Call
Novavax's management will host its quarterly conference call at
About Novavax
Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary virus-like particle (VLP) technology. The Company produces these VLP based, potent recombinant vaccines utilizing a new, efficient manufacturing solution. 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
Certain statements contained herein constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding future product development and related clinical trials and future research and development, including Food and Drug Administration approval and product sales. 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: our ability to progress any product candidates into pre-clinical or clinical trials; the scope, rate and progress of our preclinical studies and clinical trials and other research and development activities; clinical trial results; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain rights to technology; our ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration; the cost, timing and success of regulatory filings and approvals; our ability to obtain adequate financing in the future through product licensing, co- promotional arrangements, public or private equity or debt financing or otherwise; general economic and business conditions; competition; business abilities and judgment of personnel; availability of qualified personnel; 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. All forward-looking statements made herein are based on information available to the Company on the date hereof and speak only as of the date of this earnings call, 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 March 31, 2008 2007 Revenues: Net product sales $ - $ 204 Contract research and development 458 241 Royalties, milestone and licensing fees - 16 Total revenues 458 461 Operating costs and expenses: Cost of products sold - 50 Research and development 4,434 3,653 Selling, general and administrative 3,244 4,597 Total operating costs and expenses 7,678 8,300 Loss from continuing operations before interest (7,220) (7,839) Interest income, net 117 604 Loss from continuing operations (7,103) (7,235) Loss from discontinued operations (652) (1,153) Net loss $ (7,755) $ (8,388) Basic and diluted loss per share: Loss per share from continuing operations $ (0.12) $ (0.12) Loss per share from discontinued operations (0.01) (0.02) Net loss per share (0.13) (0.14) Basic and diluted weighted average number of common shares outstanding 61,280,155 61,221,075 SELECTED BALANCE SHEET DATA (in thousands) As of March 31, 2008 As of December 31, (unaudited) 2007 Cash and cash equivalents $ 14,702 $ 4,350 Short-term investments 26,191 42,139 Total current assets 43,036 49,016 Working capital 34,711 42,810 Total assets 86,221 91,291 Long term debt 21,711 21,629 Stockholders' equity 55,795 63,065
SOURCE Novavax, Inc.
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