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:
- In October 2012, we reported on two Phase I clinical trials that demonstrated the safety and immunogenicity of varying dose-levels of this vaccine, with and without two separate adjuvants, as well as statistically significant effects on immune response. The data suggested that our vaccine may be protective even when the vaccine strain does not perfectly match a pandemic virus strain, which is an important consideration in the emergent response to a pandemic. We believe that the data generated for our pandemic influenza vaccine are as good as or better than any published pandemic influenza clinical trial results.
- In July 2012, we reported that a Phase II dose-ranging clinical trial of our quadrivalent seasonal influenza vaccine met the U.S. Food and Drug Administration's seroprotection requirements for all four viral strains that were included in the vaccine, as well as the agency's required seroconversion levels for three out of the four strains. The vaccine was well-tolerated and produced no vaccine-related serious adverse events.
- In October 2012, we initiated two clinical trials for our RSV vaccine candidate: a Phase II clinical trial in women of child bearing age and a Phase I clinical trial in the elderly.
- In September 2012, we presented findings from our RSV vaccine development program at the 8th Annual International Respiratory Virus Symposium (RSV 2012) meeting. Poster presentations described the functional activity of our vaccine candidate and reported both pre-clinical and Phase I clinical trial results demonstrating induction of functional, neutralizing antibodies to multiple sites on the F protein that have a high binding affinity.
- During 2012, we recognized approximately $20 million in revenue from BARDA to fund the advanced development research contract for our influenza vaccine program.
- In July 2012, we signed a $2 million clinical development agreement with PATH to support a Phase II clinical trial of our RSV vaccine in women of childbearing age.
- In July 2012, CPL Biologicals (CPLB), our joint venture with Cadila Pharmaceuticals in India, announced a new collaboration with the International Centre for Genetic Engineering and Biotechnology to develop a new malaria vaccine candidate. The program is funded by the government of India and managed by the Malaria Vaccine Development Program, a New Delhi-based not-for-profit organization established to support the development of malaria vaccines.
- CPLB also initiated two Phase I clinical trials in India: one in its trivalent seasonal influenza vaccine candidate and the other in its pandemic (H1N1) influenza vaccine candidate. Both vaccine candidates were manufactured in India using Novavax' gene sequences and VLP platform technology.
- In 2012, we raised net proceeds of approximately $54 million, completing two equity offerings which generated net proceeds of approximately $39 million and raising approximately $15 million through our at-market sales facility.
- Following the January 2013 inter-governmental-agency panel review of our vaccine-development contract with BARDA, we will continue our research activities and ultimately advance our seasonal influenza and pandemic (H5N1) influenza vaccine candidates into later-stage clinical trials under the BARDA program.
- Top-line data from our two on-going RSV clinical trials are expected to be reported during the second quarter of 2013, and the design and timing of subsequent clinical trials will be determined after these data are analyzed.
- CPLB is expected to initiate a clinical trial for a recombinant nanoparticle rabies vaccine candidate in India.
- We expect to continue to advance the company's research collaborations with CPLB in India, LG Life Sciences in South Korea and PATH.
- We are completing our expansion into new manufacturing and office facilities in Gaithersburg, Maryland and are scheduling GMP manufacturing of product for later-stage clinical trials. This facility is designed to allow us to produce vaccines for all stages of clinical development through to commercialization.
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Revenue||$ 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|
|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|
|December 31, 2012||December 31, 2011|
|Cash and cash equivalents||$ 17,399||$ 14,104|
|Total current assets||50,408||26,109|
|Total notes payable and capital lease obligation||1,205||320|
|Total stockholders' equity||80,240||53,849|
CONTACT: Frederick W. Driscoll VP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000