SPECTRAL ANNOUNCES FOURTH QUARTER AND FISCAL 2019 RESULTS TORONTO, Canada – March 27, 2020 – Spectral Medical Inc., (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the fourth quarter and for the year ended December 31, 2019. Financial Review
Revenue for the three months ended December 31, 2019 was $746,000 compared to $1,864,000 for the same three-month period last year. Revenue for the year ended December 31, 2019 was $2,868,000 compared to $3,840,000 for the prior year, representing a decrease of $972,000, or 25%.
For the quarter ended December 31, 2019, the Company reported operating costs of $2,160,000 compared to $1,420,000 for the corresponding period in 2018. Operating costs for the year ended December 31, 2019 amounted to $7,728,000 compared to $6,329,000 in 2018. Most of the Company’s expenses are incurred in its Phase III clinical trial and vary depending on the timing and level of patient enrolment. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.
Loss for the quarter ended December 31, 2019 was $1,414,000 ($0.006 per share) compared to income of $444,000 ($0.002 per share) for the same quarter last year. For the year ended December 31, 2019, the Company reported a loss of $4,860,000, ($0.02 per share), compared to a loss of $2,489,000 ($0.01 per share), for the year ended December 31, 2018.
The Company concluded the 2019 year with cash of $1,435,000 compared to $4,368,000 cash on hand as of December 31, 2018. This does not reflect the US$5,000,000 upfront rights payment from Baxter International Inc., which was received on February 21, 2020.
The total number of common shares outstanding for the Company was 225,876,683 as at December 31, 2019. About Spectral Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit www.spectraldx.com. 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.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
Dr. Paul Walker President and CEO Spectral Medical Inc. 416-626-3233 ext. 2100
pwalker@spectraldx.com | Mr. Chris Seto
CFO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com | Ali Mahdavi
Capital Markets &Investor Relations
416-962-3300
am@spinnakercmi.com | | | | | |