TORONTO, March 12 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. today announced its operational highlights and financial results for the fiscal year ended December 31, 2008.
“In 2008, we accomplished several key objectives on our path to delivering an effective treatment for severe sepsis for the U.S. market,” said Dr. Paul Walker, President and CEO of Spectral. “In September, we agreed to key terms with Toray Industries, Inc. (Toray) of Japan to obtain the exclusive development and commercial rights in the U.S. for Toraymyxin(TM), a therapeutic for the treatment of sepsis that removes endotoxin from the bloodstream, and which has been used on more than 70,000 patients to date, primarily in Europe and Japan. Together with our proprietary Endotoxin Activity Assay (EAA(TM)), used for measuring endotoxin levels in the blood, the combination has demonstrated a dramatic reduction in the mortality of patients with severe sepsis compared to standard of care in European trials. Spectral’s current focus is to seek FDA clearance for the therapeutic product.”
Financial Review
For the three-months ended December 31, 2008, Spectral reported sales of $861,000 compared to $675,000 for the corresponding period in 2007. For the year ended December 31, 2008, Spectral reported sales of $3,011,000 compared to $2,993,000 for the corresponding period in 2007. In 2008, sales of the Company’s EAA(TM) product more than doubled to $660,000, compared to $296,000 in the prior year. The distribution agreements signed in Japan, Italy, and Germany late in 2007 were primarily accountable for this revenue growth. Spectral expects further sales improvement from these existing arrangements and new sales from distribution agreements in Russia and India in 2009. Reagent sales of $239,000 in 2008 increased by 22% over last year and are expected to remain consistent in the next fiscal year. Certain pre-established royalty plateaus were reached in 2007 by a licensee of the Company’s Troponin I technology, with a resultant reduction in related revenues of $641,000. In future years, a portion of this impact should be offset as revenues from a new license agreement, signed in late 2007, are realized.
Selling, general and administrative expenses for the year ended December 31, 2008 were $3,264,000, compared to $3,167,000 for the corresponding period in 2007, and are expected to remain at these levels due to the continued maintenance of a low cost operating structure.
Research and development costs for the year ended December 31, 2008 amounted to $75,000, compared to $66,000 in 2007. The Company does not expect to incur any significant research and development expenses related to its current business in 2009.
For the three-months ended December 31, 2008, the Company reported a loss of $303,000 or ($0.01) per share compared to a loss of $698,000 or ($0.03) per share for the corresponding period in 2007. For the year ended December 31, 2008, the Company reported a loss of $1,666,000 or ($0.06) per share compared to a loss of $1,725,000 or ($0.07) per share for the corresponding period in 2007.
Cash and short term investments at December 31, 2008 totalled $3,608,000 compared with $4,204,000 at December 31, 2007. Management expects that the Company will maintain a minimum cash and short term investment balance of $3,000,000 throughout the 2009 fiscal year.
The total number of shares outstanding for the Company was 24,118,424 as at March 11, 2009.
Notice of Annual General Meeting
Spectral will hold its Annual General Meeting of Shareholders at 4:00PM on May 14, 2009 at the offices of Stikeman, Elliott LLP, Suite 5300, 199 Bay Street, Toronto, Ontario.
About Spectral Diagnostics
Spectral is a developer of innovative technologies for comprehensive disease management. Spectral’s lead product is its EAA(TM) Endotoxin Activity Assay, the only FDA approved diagnostic for the measurement of endotoxin. Spectral technologies provide accurate and timely information to clinicians enabling the early initiation of appropriate and targeted therapy. Spectral is listed on TSX under the symbol SDI.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral’s senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
CONTACT: Dr. Paul Walker, President & CEO, (416) 626-3233 ex. 2100; Casey
Gurfinkel, Investor Relations, (416) 815-0700 ext. 283,
cgurfinkel@equicomgroup.com
