“In 2008, we accomplished several key objectives on our path to delivering an effective treatment for severe sepsis for the U.S. market,” said Paul Walker, president and chief executive officer 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. 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.
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.