TORONTO, ONTARIO–(Marketwired – March 30, 2017) – 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, 2016.
Financial Review
Revenue for the three months ended December 31, 2016 was $806,000 compared to $715,000 for the same three month period last year. Revenue for the year ended December 31, 2016 was $3,545,000 compared to $3,089,000 for the prior year, representing an increase of $456,000, or 15%.
For the quarter ended December 31, 2016, the Company reported operating costs of $1,842,000 compared to $3,039,000 for the corresponding period in 2015. Operating costs for the year ended December 31, 2016 amounted to $13,762,000 compared to $12,696,000 in 2015. Most of the Company’s expenses are incurred in its Phase III clinical trial and will 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, 2016 was $1,024,000 ($0.005 per share) compared to $2,400,000 ($0.01 per share) for the same quarter last year. For the year ended December 31, 2016, the Company reported a loss of $10,149,000, ($0.05 per share), compared to a loss of $9,524,000 ($0.05 per share), for the year ended December 31, 2015.
The Company concluded the 2016 year with cash and cash equivalents of $5,080,000 compared to $6,369,000 cash and cash equivalents on hand as of December 31, 2015.
The total number of shares outstanding for the Company was 207,165,587 as at December 31, 2016.
Business Update
Subsequent to year end, the Company received approval of the third module of its rolling premarket approval (“PMA”) submission from the United States Food and Drug Administration (“FDA”) for Toraymyxin™. The third PMA module details the device description, principles of operation and all manufacturing processes, including risk management and quality system integration.
Spectral remains on track to file the fourth and final module of its PMA submission with the FDA, containing clinical data, early in the second quarter of 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.
| Spectral Medical Inc. | ||||
| Consolidated Statements of Financial Position | ||||
| (in thousands of Canadian dollars) | ||||
| December 31 | December 31 | |||
| 2016 | 2015 | |||
| $ | $ | |||
| Assets | ||||
| Current assets | ||||
| Cash | 5,080 | 6,369 | ||
| Trade and other receivables | 642 | 630 | ||
| Inventories | 244 | 243 | ||
| Prepayments and other assets | 166 | 141 | ||
| 6,132 | 7,383 | |||
| Non-current assets | ||||
| Property and equipment | 634 | 717 | ||
| Intangible asset | 334 | 359 | ||
| 968 | 1,076 | |||
| Total assets | 7,100 | 8,459 | ||
| Liabilities | ||||
| Current liabilities | ||||
| Trade and other payables | 1,112 | 2,850 | ||
| Deferred revenue | 166 | 176 | ||
| Total liabilities | 1,278 | 3,026 | ||
| Equity | ||||
| Share capital | 63,084 | 53,058 | ||
| Contributed surplus | 7,849 | 7,849 | ||
| Share-based compensation | 4,103 | 3,723 | ||
| Warrants | 132 | – | ||
| Deficit | (69,346 | ) | (59,197 | ) |
| Total equity | 5,822 | 5,433 | ||
| Total liabilities and equity | 7,100 | 8,459 | ||
| Spectral Medical Inc. | ||||
| Consolidated Statements of Loss and Comprehensive Loss | ||||
| For the years ended December 31, 2016 and 2015 | ||||
| (in thousands of Canadian dollars, except for share and per share data) | ||||
| 2016 | 2015 | |||
| $ | $ | |||
| Revenue | 3,545 | 3,089 | ||
| Expenses | ||||
| Changes in inventories of finished goods and work-in-process | 233 | 199 | ||
| Inventory write-down | 135 | – | ||
| Raw materials and consumables used | 473 | 469 | ||
| Employee benefits | 3,660 | 3,546 | ||
| Consulting and professional fees | 6,708 | 6,114 | ||
| Product development | 67 | 16 | ||
| Regulatory and investor relations | 866 | 676 | ||
| Travel and entertainment | 770 | 976 | ||
| Depreciation and amortization | 224 | 172 | ||
| Foreign exchange loss (gain) | 74 | (12 | ) | |
| Other expenses | 552 | 540 | ||
| 13,762 | 12,696 | |||
| Operating loss | (10,217 | ) | (9,607 | ) |
| Finance income | 68 | 83 | ||
| Loss and comprehensive loss for the year | (10,149 | ) | (9,524 | ) |
| Basic and diluted loss per common share | (0.05 | ) | (0.05 | ) |
| Weighted average number of common shares outstanding | 204,679,282 | 188,064,621 | ||
| Spectral Medical Inc. | |||||||||||||
| Consolidated Statements of Changes in Equity | |||||||||||||
| For the years ended December 31, 2016 and 2015 | |||||||||||||
| (in thousands of Canadian dollars) | |||||||||||||
| Contributed | Share-based | ||||||||||||
| Issued capital | surplus | compensation | Warrants | Deficit | Total equity | ||||||||
| Number | $ | $ | $ | $ | $ | $ | |||||||
| Balance, January 1, 2015 | 179,737,241 | 46,879 | 7,849 | 3,542 | – | (49,450 | ) | 8,820 | |||||
| Private placement | 11,049,464 | 6,021 | – | – | – | – | 6,021 | ||||||
| Shares repurchased under NCIB | (480,000 | ) | (132 | ) | – | – | – | (223 | ) | (355 | ) | ||
| Share options exercised | 464,700 | 290 | – | (124 | ) | – | 166 | ||||||
| Loss and comprehensive loss for the year | – | – | – | – | – | (9,524 | ) | (9,524 | ) | ||||
| Share-based compensation | – | – | – | 305 | – | – | 305 | ||||||
| Balance, December 31, 2015 | 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 | ) | – | 280 | |||||
| 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 | |||||
| Spectral Medical Inc. | |||||
| Consolidated Statements of Cash Flows | |||||
| For the years ended December 31, 2016 and 2015 | |||||
| (in thousands of Canadian dollars) | |||||
| 2016 | 2015 | ||||
| $ | $ | ||||
| Cash flow provided by (used in) | |||||
| Operating activities | |||||
| Loss and comprehensive loss for the year | (10,149 | ) | (9,524 | ) | |
| Adjustments for: | |||||
| Depreciation on property and equipment | 199 | 147 | |||
| Amortization of intangible asset | 25 | 25 | |||
| Share-based compensation | 580 | 305 | |||
| Loss on disposal of property and equipment | 6 | 7 | |||
| Changes in items of working capital : | |||||
| Trade and other receivables | (12 | ) | (47 | ) | |
| Inventories | (1 | ) | (77 | ) | |
| Prepayments and other assets | (25 | ) | 44 | ||
| Trade and other payables | (1,738 | ) | (43 | ) | |
| Deferred revenue | (10 | ) | 27 | ||
| Net cash used in operating activities | (11,125 | ) | (9,136 | ) | |
| Investing activities | |||||
| Property and equipment expenditures | (122 | ) | (403 | ) | |
| Proceeds on disposal of property and equipment | – | 22 | |||
| Net cash used in investing activities | (122 | ) | (381 | ) | |
| Financing activities | |||||
| Bought deal prospectus offering | 9,399 | – | |||
| Private placement | – | 6,021 | |||
| Share options exercised | 279 | 166 | |||
| Broker warrants exercised | 280 | – | |||
| Shares repurchased under NCIB | – | (355 | ) | ||
| Net cash provided by financing activities | 9,958 | 5,832 | |||
| Decrease increase in cash | (1,289 | ) | (3,685 | ) | |
| Cash, beginning of year | 6,369 | 10,054 | |||
| Cash, end of year | 5,080 | 6,369 | |||
Vice President and CFO
Spectral Medical Inc.
416-626-3233 ext. 2200
tbusinskas@spectraldx.com
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com