Theralase Technologies (CVE:TLT) shares rose on Monday after the company reported a 40% jump in total revenues for its fiscal 2015 and a near-doubling in Canada.
In the year ended Dec. 31, 2015, revenues rose from C$1,380,604 to C$1,945,246 from the same period in 2014, the company said.
In Canada, revenue increased 97% to C$1,691,086 from $857,723, while US revenue decreased 24% from C$283,784 to C$214,744, and international revenue decreased 84% from C$239,097 to C$39,415.
The revenue changes are directly attributable to the company's mandate of building its sales and marketing teams from scratch commencing with the Canadian market, Theralase said.
The next-generation TLC-2000 therapeutic medical laser system received Food and Drug Administration 510(k) clearance and Health Canada medical device licence approval in December, allowing the newly minted Canadian team to commence sales of this next-generation technology.
Now that the TLC-2000 is able to be sold in Canada and the United States, the focus of the company will be to commence recruitment of a high performing US sales and marketing team to increase sales of the TLC-2000 technology in the US in 2016. Once the Canadian and US markets have been established and running independently, Theralase will then focus its attention on growing its international revenues through exclusive international distribution agreements commencing in 2017.
The cost of sales for the year ended December 31, was C$629,899, resulting in a gross margin of C$1,315,347 (68% of revenue), compared with a cost of sales of C$459,323 in 2014, resulting in a gross margin of C$921,281 (67% of revenue).
The company is currently completing the sterilisation and mechanical testing of its TLD-3400 medical laser probes used to activate TLD-1433 in the bladder of patients inflicted with NMIBC. The testing is expected to be completed by the end of May allowing resubmission of an investigational testing authorisation (ITA) to Health Canada at the beginning of June with an expected approval date in mid-June.
Pending ITA approval, Theralase and University Health Network will immediately commence enrolling patients in a phase Ib NMIBC clinical study with primary outcome measures of safety and tolerability, secondary outcomes of pharmacokinetics (where the PDC accumulates in the body and how it exits the body) and an exploratory outcome measure of efficacy.
"The company has successfully executed on the majority of its strategic initiatives in 2015," said Roger Dumoulin-White, president and chief executive officer of Theralase.
"The company is anticipating ITA approval in mid-June 2016 to allow an immediate commencement of a phase Ib clinical study for NMIBC, which will allow the company to dramatically increase shareholder value in 2016 by demonstrating the safety, tolerability and as an exploratory outcome measure efficacy of next-generation anti-cancer technology," he added.
Theralase shares were up 1.5% at C$0.35.