ROCKVILLE, Md., May 4, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced its financial results for the first quarter ended March 31, 2012.
The company reported a net loss of $7.3 million, or $0.06 per share, for the first quarter of 2012, compared to a net loss of $7.5 million, or $0.07 per share, for the first quarter of 2011. The company had significantly higher revenue in the first quarter of 2012 of $4.6 million as compared to $0.8 million for the same period in 2011, due primarily to revenue under the contract with the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (HHS BARDA). In conjunction with the increased HHS BARDA revenue, the cost of contract revenue increased to $3.8 million in the first quarter of 2012 as compared to $0.3 million for the same period in 2011. In addition, research and development expenses remained flat year-over-year at $5.1 million.
The increase in cost of contract revenue reflects a company decision to conduct the current Phase II dose-ranging clinical trial in Australia under its existing U.S. investigational new drug application ("IND") for its trivalent seasonal influenza vaccine candidate as opposed to waiting to conduct the trial under a new IND for its quadrivalent vaccine candidate. The company will record the outside clinical trial costs as cost of contract revenue until it submits the data from the trial for FDA review, expected in the second half of 2012. The outside clinical trial costs for this trial will be submitted for reimbursement to HHS BARDA and recorded as revenue by the company following its submission of the data to the quadrivalent IND. The financial impact of this delay in revenue recognition is based on this trial's outside clinical trial costs that are expected to total approximately $3.1 million, of which $1.7 million was incurred through March 31, 2012.
General and administrative expenses increased to $3.2 million in the first quarter of 2012 as compared to $2.8 million for the same period in 2011, due primarily to non-cash expenses associated with the company's new office facility and higher professional fees.
As of March 31, 2012, the company had $20.7 million in cash and cash equivalents and short-term investments compared to $18.3 million as of December 31, 2011. Net cash used in operating activities for the first quarter of 2012 was $4.2 million compared to $9.0 million for the same period in 2011, a 53% reduction from the prior year due primarily to revenue under the HHS BARDA contract.
Key Highlights during the First Quarter of 2012:
Launched a Phase II dose-ranging clinical trial of the company's trivalent and quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidates in Australia. The trial will evaluate the immunogenicity and safety of three dose levels of the company's seasonal recombinant VLP influenza vaccine candidates in healthy adults between the ages of 18 and 64.
Presented positive results from a Phase I trial of the company's recombinant nanoparticle vaccine candidate against respiratory syncytial virus (RSV) at the XIV International Symposium on Viral Infections. Findings from this Phase I trial are consistent with pre-clinical results in relevant animal models, which indicated that the company's vaccine candidate was generally well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV.
Reported manufacturing progress and preparations to begin clinical testing of influenza and rabies vaccines under the company's joint venture in India with Cadila Pharmaceuticals. Rabies is the largest selling vaccine in India and China is the largest market with 12-15 million vaccine doses annually; and
Expanded the company's senior management team with the appointments of John Herrmann III as Vice President and General Counsel and Mervyn Hamer as Vice President of Manufacturing.
"The first quarter was a very productive period for our company as we launched a Phase II trial of our seasonal influenza vaccine candidates and reported the very encouraging, positive results from our Phase I RSV trial," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "The Phase II seasonal influenza vaccine trial is particularly important because we expect that it will help us establish the immunogenicity, safety and tolerability of our quadrivalent seasonal influenza VLP vaccine candidate. The data resulting from this trial will aid in determining the most effective and appropriate dose for evaluation in our upcoming Phase IIb dose-confirmatory trial and ultimately in our Phase III registration trial. In addition, the data from our Phase I RSV trial continues to drive interest among potential partners for this important disease target. We expect to launch two RSV clinical trials in both the elderly and women-of-child bearing-age populations in the second half of 2012."
Novavax's management will host its quarterly conference call today at 10:00 a.m. EDT. The live conference call will be accessible on Novavax's website at www.novavax.com under "Investor Info/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 60 days after the call and a replay of the conference call will be available beginning today at 1:00 pm through July 04, 2012. To access the replay of the conference call, dial 1 (855) 859-2056 (Domestic) or 1 (404) 537-3406 (International) and enter passcode 76044510.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.
Forward Looking Statements
Statements herein relating to the future of Novavax and its ongoing development of its vaccine products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, that may cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2011, and filed with the Securities and Exchange Commission. Novavax cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. Investors, potential investors, and others should give careful consideration to risks and uncertainties and are encouraged to read Novavax filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and Novavax undertake no obligation to update or revise any of the statements.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
Three Months Ended
Revenue $ 4,642 $ 834
Costs and expenses:
Cost of revenue 3,786 343
Research and development 5,077 5,071
General and administrative 3,246 2,850
Total costs and expenses 12,109 8,264
Loss from operations (7,467) (7,430)
Interest income (expense), net 30 44
Change in fair value of warrant liability 101 (67)
Net loss $ (7,336) $ (7,453)
Basic and diluted net loss per share $ (0.06) $ (0.07)
Basic and diluted weighted average
number of common shares outstanding 120,558 111,188
SELECTED BALANCE SHEET DATA
2012 December 31,
Cash and cash equivalents $ 13,873 $ 14,104
Short-term investments 6,847 4,205
Total current assets 26,442 26,109
Working capital 18,601 18,530
Total assets 68,637 66,576
Total notes payable 407 320
Total stockholders' equity 54,324 53,849
CONTACT: Frederick W. Driscoll
VP, Chief Financial Officer and Treasurer