NOVAVAX Reports Fourth Quarter and 2011 Year-End Financial Results
For the fourth quarter of 2011,
Key highlights of 2011:
February 2011, we were awarded a $97 million3-year contract from BARDA to develop and scale-up our seasonal and pandemic influenza vaccine candidates. BARDA has an option to extend our contract for an additional $82 millionover a 2-year extension period. During 2011, we recognized revenue of approximately $15 million, made significant progress in product characterization and production scale-up and are progressing forward with our multi-year clinical-development program. We conducted a Phase I clinical trial testing our vaccine candidate against respiratory syncytial virus (RSV) in 150 healthy adults in a blinded, placebo-controlled, escalating-dose study. In October 2011, we presented interim top-line data from the trial at the 5th Vaccine and ISV Annual Global Conference. The positive results were consistent with pre-clinical studies and showed that the vaccine candidate was well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV. During 2011, the company made the following senior-executive appointments: Stanley C. Erckwas named President and Chief Executive Officer, Louis Fries III M.D., was named Vice President, Clinical and Medical Affairs, Gregory Glenn, M.D., was named Senior Vice President and Chief Medical Officer, Timothy Hahn, Ph.D., was named Senior Vice President of Manufacturing and Process Development, Jane Halpern, Ph.D., was named Vice President Regulatory Affairs, Erica Shane, Ph.D., was named Vice President Process Development and Russell P. Wilsonwas named Senior Vice President, Business Development. In early 2012, the company appointed Mervyn L. Hameras Vice President, Manufacturing and John A. Herrmann III, J.D. as Vice President, General Counsel and Secretary. In February 2011, we entered into a licensing agreement with LG Life Sciences(LGLS) that allows LGLS to use our VLP technology to develop and commercialize our influenza vaccines in South Koreaand certain other emerging-market countries. LGLS holds an exclusive license to our influenza VLP technology in South Koreaand a non-exclusive license in the other specified countries. In November, we announced a long-term lease arrangement to occupy 74,000 square feet of manufacturing, laboratory and office space in two facilities in Gaithersburg, MD. The main facility will become the primary commercial-scale manufacturing facility for production of the company's vaccines after moderate modifications that are expected to be completed in 2012. CPL Biologics (CPLB), our joint venture in Indiawith Cadila Pharmaceuticals Ltd., is developing a promising new rabies vaccine developed by Novavaxfor which it is now conducting toxicology studies prior to initiating human clinical trials. CPLB has also completed validation testing of its new manufacturing facility to produce clinical and commercial supplies of influenza and rabies vaccine candidates and has made excellent early-stage progress with the development of other new vaccine candidates. In October, Novavaxwas awarded a $1.3 millioncontract with the U.S. Department of Homeland Securityto develop a VLP vaccine countermeasure to protect the United Statesfrom foot-and-mouth disease (FMD), a highly contagious viral disease of livestock and a potential threat to U.S. agriculture. The company will use these funds over the next two and a half years to develop a VLP that, unlike current FMD vaccines, would not require the use of infectious FMD virus to be manufactured. We continued to present our clinical findings at medical and scientific conferences throughout the year, including the 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials at which we presented the final positive results of our H1N1 VLP seasonal influenza study in Mexico. We also published results from this study in the journal Vaccine and the results from our Phase I/IIa pandemic H5N1 influenza study in Journal of Virology.
Anticipated events in 2012:
March 2012, we initiated a Phase II trial under our BARDA contract to select the optimal dose of our quadrivalent seasonal influenza VLP vaccine candidate. We also expect to initiate a dose-confirmatory Phase II trial later this year. We expect to launch two Phase I trials of our H5N1 VLP influenza vaccine candidate utilizing multiple adjuvants under our BARDA contract. We expect to initiate two dose-ranging Phase I/II trials of our RSV vaccine candidate in the elderly and in women of child-bearing age.
Statements herein relating to the future of
NOVAVAX, INC. CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share information) Three Months Ended Twelve Months Ended December 31, December 31, 2011 2010 2011 2010 (unaudited) Revenue $ 5,845 $ 51 $ 14,688 $ 343 Costs and expenses: Cost of revenue 3,206 - 7,003 - Research and development 4,446 4,806 17,885 28,032 General and administrative 2,453 2,279 11,379 10,805 Total costs and expenses 10,105 7,085 36,267 38,837 Loss from operations (4,260) (7,034) (21,579) (38,494) Interest income (expense), net 28 48 127 180 Other income 26 485 26 485 Change in fair value of warrant liability 501 (100) 2,474 1,671 Loss from operations before income tax (3,705) (6,601) (18,952) (36,158) Income tax (benefit) expense - (315) 412 (450) Net loss $ (3,705) $ (6,286) $ (19,364) $ (35,708) Basic and diluted net loss per share $ (0.03) $ (0.06) $ (0.17) $ (0.34) Basic and diluted weighted average number of common shares outstanding 115,263 110,958 113,610 104,768
SELECTED BALANCE SHEET DATA (in thousands) December 31, December 31, 2011 2010 Cash and cash equivalents $ 14,104 $ 8,061 Short-term investments 4,205 23,615 Total current assets 26,109 33,337 Working capital 18,530 23,071 Total assets 66,576 74,844 Total notes payable 320 400 Total stockholders' equity 53,849 59,050
Frederick W. DriscollVP, Chief Financial Officer and Treasurer Novavax, Inc.240-268-2000