Novavax Announces First Quarter 2006 Financial Results
MALVERN, Pa., May 15 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) today announced its first quarter 2006 operational and financial results.
Recent Significant Events at Novavax include: -- Strengthened Balance Sheet by raising $58MM in equity capital and converting $7MM of outstanding convertible bonds into equity -- Attracted well-known sophisticated institutional investors including Kleiner Perkins Caufield & Byers and Prospect Venture Partners as new shareholders -- Elected Dr. James B. Tananbaum as a Board of Director member of Novavax -- Strengthened scientific vaccine development team with the appointments of Drs. Rick Bright, Jinyou Zhang, and Niranjan Kumar -- Made significant progress on influenza vaccine pre-clinical programs with both antigen and adjuvant platforms -- Responded to US Department of Health and Human Services Request for Proposal (RFP) for advanced development of antigen sparing influenza vaccines -- Completed renovation and validation for current "Good Manufacturing Practices" (cGMP) compliance of operations facility in Rockville, MD to create capability for manufacturing clinical grade materials
Commenting on the first quarter 2006 operating results, Dr. Rahul Singhvi, President and Chief Executive Officer, stated, "We had a solid first quarter in which we made significant progress towards all of our strategic goals. We made progress with our influenza vaccine programs, consistent with our vision to create best-in-class pandemic and seasonal influenza vaccines. We raised enough capital to continue advanced stage development of both vaccines and responded to a US DHHS RFP to access government funding. We attracted strong investors and recruits to reduce our execution risk and enhanced our intellectual property estate by filing several patent applications. We remain optimistic that our work at Novavax will result in the development of next generation vaccines against emerging infectious diseases, such as the H5N1 avian influenza."
First Quarter Financial Results
Revenues for the first quarter ended March 31, 2006 totaled $1.3 million, up 35% from $1.0 million reported in the year-ago quarter. Product revenues consisting primarily of ESTRASORB(R) sales to Esprit Pharma totaled $0.7 million for the period. This compares to product sales of $0.7 million reported in the first quarter of 2005. Contract research and development revenues for the first quarter were $0.5 million, up from $0.2 million reported in the 2005 period. This increase was a result of additional commercial contract work completed at our manufacturing facility in Pennsylvania. Also included in total revenues for the first quarter was $0.1 million in royalties from Esprit Pharma on ESTRASORB(R) sales.
Cost of products sold for the three-month period were reduced to $1.2 million versus $2.0 million for the same period last year. The 2006 quarter includes $0.4 million in idle capacity costs at our manufacturing facility compared to similar costs totaling $1.5 million in the year-ago quarter. The company incurred $0.3 million in excess inventory costs over market for the first quarter, which reflects its current production costs over the sales price of ESTRASORB(R) driven by dependence of the production costs on sales volume.
Research and development costs for the first quarter increased to $2.0 million compared to $1.2 million for the three-month period a year ago. The 66% increase in R&D was primarily due to higher spending to support the development of the Company's influenza vaccines, as well as costs related to the recording of stock-based compensation in accordance with Statement of Financial Accounting Standard No. 123 (revised) Accounting for Stock-Based Compensation ("SFAS 123R").
Selling and marketing costs were significantly reduced during the first quarter to $38 thousand from $4.1 million for the same period last year. The decrease resulted from the Company's transition from a commercial business to new product development. Novavax eliminated its sales force and marketing programs during 2005.
Total general and administrative costs were $2.7 million for the quarter, compared with $2.1 last year during the first quarter period. The increase was due to $0.6 million of costs related to the recording of stock-based compensation in accordance with SFAS 123R.
For the quarter, Novavax reported a net loss of $5.5 million, or the equivalent of 11 cents loss per share, down from an $8.9 million net loss or the equivalent of 22 cents loss per share in the year-ago period.
As of March 31, 2006, Novavax had $83.9 million in cash and cash-equivalents compared to $31.9 million at December 31, 2005, for an increase of $52.0 million. The Company received net proceeds of $20.0 million and $36.1 million from equity offerings in February and March, respectively. Both offerings were issued pursuant to existing shelf registration statements.
The Company will hold an investor conference call to discuss its financial results at 10:00 a.m. EDT on May 15, 2006. The call will be hosted by Mr. Gary C. Evans, Chairman of the Board and Dr. Rahul Singhvi, President and CEO of Novavax. Other participants on the call will include senior management of Novavax. A question and answer session will follow the financial results overview. The dial in number for the conference call is 1-800-599-9795 (International 1-617-786-2905), pass code 23869726.
A live audio webcast of the conference call will be available through http://www.novavax.com. Please connect to this website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. A replay of the webcast will be available for 90 days starting on May 15, 2006 at http://www.novavax.com. A replay of the conference call will also be available by telephone starting on May 15, 2006 at 12:00 noon through May 22, 2006. To access the replay, dial (888) 286-8010 and enter pass code 18031915 followed by the number sign.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes(R), non-phospholipid vesicles and dendrimer technologies. The company is developing a pandemic flu vaccine against H5N1, H9N2 and other avian influenza viruses and a seasonal flu vaccine against human influenza strains using its VLP and Novasome adjuvant technologies. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB(R). In addition to MNP, Novavax drug delivery technologies include Novasomes(R) and Sterisomes(R), solvent and oil free emulsions for subcutaneous depot injection. The company has several products utilizing the MNP technology in various stages of development.
Novavax, Inc. Consolidated Statements of Operations (in thousands, except share and per share information) Unaudited Three-months ended March 31, March 31, 2006 2005 Revenues: Net product sales $719 $719 Contract research and development 474 243 Royalties, milestone and licensing fees 110 - Total revenues 1,303 962 Operating costs and expenses: Cost of products sold 1,233 1,979 Excess inventory costs over market 315 - Research and development 2,032 1,222 Selling and administrative 38 4,057 General and administrative 2,720 2,121 Total operating costs and expenses 6,338 9,379 Loss from operations (5,035) (8,417) Interest expense, net (460) (469) Net loss $(5,495) $(8,886) Basic and diluted loss per share $(0.11) $(0.22) Basic and diluted weighted average number of common shares outstanding 52,267,386 39,553,876 Selected Balance Sheet Data (in thousands) Unaudited As of As of March 30, December 31, 2006 2005 Cash and cash equivalents $83,941 $31,893 Total current assets $89,450 $37,611 Working capital $85,907 $32,735 Total assets $135,432 $84,382 Long term obligations $22,784 $29,854 Stockholders' equity $109,105 $49,652
Forward Looking Statements
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners; competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at www.sec.gov.
SOURCE Novavax, Inc.
CONTACT: Cheryl Marley of Novavax, Inc., +1-484-913-1202,