Nasdaq

Spectral Announces Fourth Quarter and Fiscal 2017 Results

29-03-2018

TORONTO, March 29, 2018 (GLOBE NEWSWIRE) -- Spectral Medical Inc., (TSX:EDT), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its financial results for the fourth quarter and for the year ended December 31, 2017.

Financial Review

Revenue for the three months ended December 31, 2017 was $918,000 compared to $806,000 for the same three-month period last year. Revenue for the year ended December 31, 2017 was $3,806,000 compared to $3,545,000 for the prior year, representing an increase of $261,000, or 7%.

For the quarter ended December 31, 2017, the Company reported operating costs of $1,960,000 compared to $1,842,000 for the corresponding period in 2016. Operating costs for the year ended December 31, 2017 amounted to $7,745,000 compared to $13,762,000 in 2016.  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, 2017 was $1,042,000 ($0.006 per share) compared to $1,024,000 ($0.005 per share) for the same quarter last year. For the year ended December 31, 2017, the Company reported a loss of $3,939,000, ($0.02 per share), compared to a loss of $10,149,000 ($0.05 per share), for the year ended December 31, 2016.

The Company concluded the 2017 year with cash of $1,449,000 compared to $5,080,000 cash on hand as of December 31, 2016.

The total number of common shares outstanding for the Company was 207,459,022 as at December 31, 2017.

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 150,000 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 350,000 patients are diagnosed with severe sepsis and septic shock in North America each year. 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
Ali Mahdavi
Capital Markets &Investor Relations
416-962-3300
am@spinnakercmi.com

Spectral Medical Inc.
Consolidated Statements of Financial Position
 
(in thousands of Canadian dollars)
 
    December 31 2017     December 31 2016  
    $     $  
             
Assets            
Current assets            
Cash   1,449     5,080  
Trade and other receivables   881     642  
Inventories   191     244  
Prepayments and other assets   73     166  
    2,594     6,132  
Non-current assets        
Property and equipment   570     634  
Intangible asset   309     334  
         
Total assets   3,473     7,100  
         
Liabilities        
Current liabilities        
Trade and other payables   612     1,112  
Deferred revenue   26     166  
Total liabilities   638     1,278  
         
Equity        
Share capital   63,225     63,084  
Contributed surplus   7,849     7,849  
Share-based compensation   4,914     4,103  
Warrants   132     132  
Deficit   (73,285 )   (69,346 )
Total equity   2,835     5,822  
         
Total liabilities and equity   3,473     7,100  

Spectral Medical Inc.
Consolidated Statements of Loss and Comprehensive Loss
For the years ended December 31, 2017 and 2016
             
(in thousands of Canadian dollars, except for share and per share data)            
             
    2017     2016  
    $      $  
         
Revenue   3,806     3,545  
         
Expenses        
Changes in inventories of finished goods and work-in-process   232     233  
Inventory write-down   25     135  
Raw materials and consumables used   245     473  
Employee benefits   3,534     3,660  
Consulting and professional fees   1,829     6,708  
Product development   238     67  
Regulatory and investor relations   479     866  
Travel and entertainment   280     770  
Depreciation and amortization   222     224  
Foreign exchange loss   67     74  
Other expenses   594     552  
    7,745     13,762  
         
Operating loss   (3,939 )   (10,217 )
         
Finance income   -     68  
         
Loss and comprehensive loss for the year   (3,939 )   (10,149 )
         
Basic and diluted loss per common share   (0.02 )   (0.05 )
         
Weighted average number of common shares outstanding   207,329,193     204,679,282  

Spectral Medical Inc.
Consolidated Statements of Changes in Equity
For the years ended December 31, 2017 and 2016
 
(in thousands of Canadian dollars)
               
    Issued capital  Contributed
surplus
Share-based
compensation
  Warrants   Deficit   Total equity  
    Number $ $ $   $   $   $  
Balance, January 1, 2016   190,771,405 53,058 7,849 3,723   -   (59,197 ) 5,433  
Bought deal prospectus offering   15,106,804 9,163 - -   236   -   9,399  
Share options exercised   887,378 479 - (200 ) -   -   279  
Broker warrants exercised   400,000 384 - -   (104 ) -   200  
Loss and comprehensive loss for the year   - - - -   -   (10,149 ) (10,149 )
Share-based compensation   - - - 580   -   -   580  
Balance, December 31, 2016   207,165,587 63,084 7,849 4,103   132   (69,346 ) 5,822  
Share options exercised   293,435 141 - (57 ) -   -   84  
Loss and comprehensive loss for the year   - - - -   -   (3,939 ) (3,939 )
Share-based compensation   - - - 868   -   -   868  
Balance, December 31, 2017   207,459,022 63,225 7,849 4,914   132   (73,285 ) 2,835  
Spectral Medical Inc.
Consolidated Statements of Cash Flows
For the years ended December 31, 2017 and 2016
 
(in thousands of Canadian dollars)            
             
    2017     2016  
    $     $  
Cash flow provided by (used in)        
         
Operating activities        
Loss and comprehensive loss for the year   (3,939 )   (10,149 )
Adjustments for:        
Depreciation on property and equipment   197     199  
Amortization of intangible asset   25     25  
Share-based compensation   868     580  
(Gain) loss on disposal of property and equipment   (13 )   6  
Changes in items of working capital :        
Trade and other  receivables   (239 )   (12 )
Inventories   53     (1 )
Prepayments and other assets   93     (25 )
Trade and other payables   (500 )   (1,738 )
Deferred revenue   (140 )   (10 )
Net cash used in operating activities   (3,595 )   (11,125 )
         
Investing activities        
Property and equipment expenditures   (135 )   (122 )
Proceeds on disposal of property and equipment   15     -  
Net cash used in investing activities   (120 )   (122 )
         
Financing activities        
Bought deal prospectus offering   -     9,399  
Share options exercised   84     279  
Broker warrants exercised   -     280  
Net cash provided by financing activities   84     9,958  
         
Decrease increase in cash   (3,631 )   (1,289 )
         
Cash, beginning of year   5,080     6,369  
Cash, end of year   1,449     5,080