ROCKVILLE, Md., March 1, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced financial results for the fourth quarter and year-ended December 31, 2012.
For the fourth quarter of 2012, Novavax reported a net loss of $8.0 million, or $0.06 per share, compared to a net loss of $3.7 million, or $0.03 per share, in the fourth quarter of 2011. For 2012, the company reported a net loss of $28.5 million, or $0.22 per share, compared to a net loss of $19.4 million, or $0.17 per share, for 2011. The increase in the net loss in 2012 compared to 2011 was primarily a result of higher research and development spending, including increased costs related to respiratory syncytial virus (RSV) clinical trials, higher employee-related costs and expenses associated with the company's new manufacturing facility.
At December 31, 2012, Novavax had cash, cash equivalents and investments totaling $50.3 million compared to $18.3 million at December 31, 2011. Net cash used in operating activities for 2012 was $18.2 million compared to $23.6 million for 2011, a 23% reduction from the prior year. Working capital at December 31, 2012 was $38.7 million compared to $18.5 million at December 31, 2011, which represents a 109% increase.
Stanley C. Erck, President and Chief Executive Officer of Novavax, stated, "In 2012 we made significant progress across our complete pipeline of vaccine candidates, with positive clinical data announced for our RSV vaccine candidate, as well as our seasonal and pandemic (H5N1) influenza vaccines. Of particular note are results we announced last October from two Phase I pandemic (H5N1) influenza vaccine trials, which showed highly robust immunogenicity at multiple dose levels both with and without two separate adjuvants, and evidence of cross protection against a mismatched strain. This positive influenza data has undergone inter-governmental-agency panel review, and the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) is continuing support of our vaccine advanced development contract.
Mr. Erck continued, "In addition, we signed a $2 million clinical development agreement with PATH to support the Phase II clinical trial of our RSV vaccine candidate in women of childbearing age. We expect to report top-line data from this study in April and, as a result, we believe our program is currently the most advanced RSV vaccine development effort in the pharmaceutical industry."
Key Highlights of 2012:
In 2012, we initiated five clinical trials, enrolling approximately 1,700 subjects in three separate clinical development programs, while enhancing our existing development alliances and adding a new development alliance.
Pandemic (H5N1) Influenza Vaccine Program:
Seasonal Influenza Vaccine Program:
RSV Vaccine Program:
Corporate and Alliance Developments:
Anticipated Events in 2013:
Conference Call
Novavax' management will host the company's quarterly conference call today at 10:00 a.m. Eastern time. The conference call will be accessible at that time on Novavax' 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 April 29, 2013. To access the replay of the conference call, dial 1 (855) 859-2056 (Domestic) or 1 (404) 537-3406 (International) and enter passcode 13572606.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces 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, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have 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 VLP vaccine products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could 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 (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.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 we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
NOVAVAX, INC. | ||||
CONDENSED STATEMENTS OF OPERATIONS | ||||
(in thousands, except per share information) | ||||
Three Months Ended | Twelve Months Ended | |||
December 31, | December 31, | |||
2012 | 2011 | 2012 | 2011 | |
(unaudited) | ||||
Revenue | $ 4,567 | $ 5,845 | $ 22,076 | $ 14,688 |
Costs and expenses: | ||||
Cost of revenue | 1,953 | 3,206 | 14,692 | 7,003 |
Research and development | 9,411 | 4,446 | 26,061 | 17,885 |
General and administrative | 2,697 | 2,453 | 10,988 | 11,379 |
Total costs and expenses | 14,061 | 10,105 | 51,741 | 36,267 |
Loss from operations | (9,494) | (4,260) | (29,665) | (21,579) |
Interest income (expense), net | 33 | 28 | 133 | 127 |
Other income | 45 | 26 | 45 | 26 |
Realized gains on short-term investments | 879 | ― | 879 | ― |
Change in fair value of warrant liability | 502 | 501 | 101 | 2,474 |
Loss from operations before income tax | (8,035) | (3,705) | (28,507) | (18,952) |
Income tax expense | ― | ― | ― | 412 |
Net loss | $ (8,035) | $ (3,705) | $ (28,507) | $ (19,364) |
Basic and diluted net loss per share | $ (0.06) | $ (0.03) | $ (0.22) | $ (0.17) |
Basic and diluted weighted average | ||||
number of common shares outstanding | 145,069 | 115,263 | 131,726 | 113,610 |
SELECTED BALANCE SHEET DATA | ||
(in thousands) | ||
December 31, 2012 |
December 31, 2011 |
|
Cash and cash equivalents | $ 17,399 | $ 14,104 |
Investments | 32,945 | 4,205 |
Total current assets | 50,408 | 26,109 |
Working capital | 38,733 | 18,530 |
Total assets | 102,345 | 66,576 |
Total notes payable and capital lease obligation | 1,205 | 320 |
Total stockholders' equity | 80,240 | 53,849 |