ROCKVILLE, Md., Nov. 2, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced financial results for the third quarter and nine months ended September 30, 2012.
Third-Quarter 2012 and Subsequent Highlights:
- Reported positive top-line results from two Phase I clinical trials of Novavax' pandemic (H5N1) influenza vaccine under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). The studies met their primary objectives of demonstrating the safety and immunogenicity of varying dose levels of the vaccine with and without an adjuvant, supporting further development of the vaccine.
- Raised $27 million through the sale of common stock to institutional investors under an existing shelf registration statement filed with the Securities and Exchange Commission. Cash on hand is expected to support operations for more than two years.
- Initiated and enrolled a Phase I clinical trial in elderly adults to evaluate the immunogenicity and safety of two doses of Novavax' RSV vaccine candidate with and without aluminum phosphate as an adjuvant.
- Initiated and enrolled a Phase II clinical trial in women of childbearing age to evaluate the immunogenicity and safety of two doses of Novavax' RSV vaccine candidate with and without aluminum phosphate as an adjuvant. The study is being conducted in collaboration with PATH, which is providing approximately $2 million to support the study.
- At the 8th Annual International Respiratory Virus Symposium in Santa Fe, presented results of pre-clinical and clinical trials of Novavax' RSV vaccine candidate demonstrating that immunization with the nanoparticle vaccine may be more protective than live-viral, naturally induced immunity.
- Announced a new collaboration between CPL Biologicals, its joint venture with Cadila Pharmaceuticals in India, and the International Centre for Genetic Engineering and Biotechnology to develop a new malaria vaccine candidate. The program will be 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.
Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: "With the recent report of the very positive results from the Phase I trials of our H5N1 influenza vaccine candidate and the advancement of our RSV vaccine candidate into new clinical trials, we are gaining valuable clinical information and making great progress with our development partners, BARDA and PATH. These programs have also gained the financial support of sophisticated life-science institutional investors whose recent investments improve our capital position that is expected to fund our operations for at least the next two years. Thanks to our employees, development partners and investors, we are now preparing to advance our three promising vaccine candidates into later-stage clinical testing next year to confirm their safety and immunogenicity in addressing urgent public health needs."
Third-Quarter and Nine-Month 2012 Financial Results:
Novavax reported a net loss of $7.2 million, or $0.05 per share, for the third quarter of 2012 compared to a net loss of $3.2 million, or $0.03 per share, for the third quarter of 2011. For the nine months ended September 30, 2012, the net loss was $20.5 million, or $0.16 per share, compared to a net loss of $15.7 million, or $0.14 per share, for the same period in 2011. The primary reason for the increased loss for the third quarter of 2012, as compared to the same period in 2011, was due to higher research and development expenses and the unfavorable impact of the change in the fair value of the warrant liability.
Revenue in the third quarter of 2012 increased to $5.8 million, as compared to $5.0 million for the same period in 2011, as a result of the company's contract with BARDA. In conjunction with this increased BARDA revenue, cost of revenue increased to $3.8 million in the third quarter of 2012 as compared to $2.2 million for the same period in 2011.
Research and development (R&D) expenses for the third quarter of 2012 were $6.4 million as compared to $4.0 million in the same period in 2011. The increase in R&D expenses was due primarily to increased costs relating to our RSV clinical trials, higher employee-related costs and expenses associated with our new manufacturing facility. General and administrative expenses were $2.4 million for the third quarter of 2012 as compared to $2.7 million for the same period in 2011.
As of September 30, 2012, the company had $28.4 million in cash and cash equivalents and short-term investments compared to $18.3 million as of December 31, 2011. The September 30, 2012 cash, cash equivalents and short-term investments balance does not include the $27 million, which the company raised from the sale of common stock in October 2012. Net cash used for operating activities during the nine months ended September 30, 2012 was $14.1 million, compared to $20.8 million for the same period in 2011, a 32% reduction from the prior-year period due primarily to revenue under the BARDA contract.
Novavax' management will host its quarterly conference call today at 10:00 a.m. Eastern time today. The live conference call will be accessible 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. To access the replay of the conference call, dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and enter pass code 58585210.
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.
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. Statements herein relating to the future of Novavax, its business opportunities, economic performance 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||Nine Months Ended|
|September 30,||September 30,|
|Revenue||$ 5,765||$ 5,008||$ 17,510||$ 8,843|
|Costs and expenses:|
|Cost of revenue||3,838||2,190||12,740||3,763|
|Research and development||6,395||4,049||16,649||13,474|
|General and administrative||2,381||2,737||8,291||8,926|
|Total costs and expenses||12,614||8,976||37,680||26,163|
|Loss from operations||(6,849)||(3,968)||(20,170)||(17,320)|
|Interest income (expense), net||33||20||99||100|
|Change in fair value of warrant liability||(401)||736||(401)||1,973|
|Loss from operations before income tax||(7,217)||(3,212)||(20,472)||(15,247)|
|Income tax expense||―||―||―||412|
|Net loss||$ (7,217)||$ (3,212)||$ (20,472)||$ (15,659)|
|Basic and diluted net loss per share||$ (0.05)||$ (0.03)||$ (0.16)||$ (0.14)|
|Basic and diluted weighted average number of common shares outstanding||134,178||115,107||127,246||113,053|
|SELECTED BALANCE SHEET DATA|
| September 30, |
|December 31, 2011|
|Cash and cash equivalents||$ 10,738||$ 14,104|
|Total current assets||36,484||26,109|
|Total notes payable and capital lease||1,259||320|
|Total stockholders' equity||61,376||53,849|