Novavax Reports Fourth Quarter and Year-End 2012 Financial Results
For the fourth quarter of 2012,
Mr. Erck continued, "In addition, we signed a
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:
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.
Seasonal Influenza Vaccine Program:
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'sseroprotection 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.
RSV Vaccine Program:
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.
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.
Corporate and Alliance Developments:
During 2012, we recognized approximately
$20 millionin revenue from BARDA to fund the advanced development research contract for our influenza vaccine program.
July 2012, we signed a $2 millionclinical development agreement with PATH to support a Phase II clinical trial of our RSV vaccine in women of childbearing age.
July 2012, CPL Biologicals (CPLB), our joint venture with Cadila Pharmaceuticalsin India, announced a new collaboration with the International Centre for Genetic Engineering and Biotechnologyto develop a new malaria vaccine candidate. The program is funded by the government of Indiaand 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 Indiausing 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 millionand raising approximately $15 millionthrough our at-market sales facility.
Anticipated Events in 2013:
January 2013inter-governmental-agency panel review of our vaccine-development contract with BARDA, we will continue our research activities and ultimately advance our seasonal influenza and pandemic (H5N1) influenza vaccine candidates into later-stage clinical trials under the BARDA program.
Top-line data from our two on-going RSV clinical trials are expected to be reported during the second quarter of 2013, and the design and timing of subsequent clinical trials will be determined after these data are analyzed.
CPLB is expected to initiate a clinical trial for a recombinant nanoparticle rabies vaccine candidate in
We expect to continue to advance the company's research collaborations with CPLB in
India, LG Life Sciencesin South Koreaand PATH.
We are completing our expansion into new manufacturing and office facilities in
Gaithersburg, Marylandand are scheduling GMP manufacturing of product for later-stage clinical trials. This facility is designed to allow us to produce vaccines for all stages of clinical development through to commercialization.
Statements herein relating to the future of
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Revenue||$ 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|
|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|
Frederick W. DriscollVP, Chief Financial Officer and Treasurer Novavax, Inc.240-268-2000