Toronto, Ontario – April 29, 2016, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on commercializing medical devices to eliminate pain and developing Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that it has increased its revenues by 40% year over year in its latest audited 2015 financial statements.
Total revenue for the year ended December 31, 2015 increased 40% from $1,380,604 to $1,945,246 from the same period in 2014.
In Canada, revenue increased 97% to $1,691,086 from $857,723, while US revenue decreased 24% from $283,784 to $214,744 and international revenue decreased 84% from $239,097 to $39,415.
The significant increase in Canadian revenue in 2015 and the corresponding decrease in US and international revenue is directly attributable to the Company’s mandate of building its sales and marketing teams from scratch commencing with the Canadian market. The next generation TLC-2000 therapeutic medical laser system received Food and Drug Administration (“FDA”) 510(k) clearance and Health Canada medical device licence approval in December 2015, 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, 2015 was $629,899 resulting in a gross margin of $1,315,347 (68% of revenue), compared to a cost of sales of $459,323 in 2014, resulting in a gross margin of $921,281 (67% of revenue).
Sales and marketing expenses for the year ended December 31, 2015 were $1,091,277 (56% of revenue), compared with $598,178 (43% of revenue) in 2014. The increase represents direct investment in the new sales and marketing teams, for launch of the next generation TLC-2000 therapeutic laser system, which will significantly increase sales in 2016 and 2017.
Administrative expenses for the year ended December 31, 2015 were $2,455,985 (170% increase) from $1,448,781 in 2014. Increases in administrative expenses for the year ended December 31, 2015 were attributable to the following:
- General and administrative expenses increased 172% due to increased spending on investor relations and research scientist activities
- Professional fees increased by 208% due to increased legal fees for additional trademark and international intellectual property patents to protect the Company’s latest technological advances in both its therapeutic laser and anti-cancer divisions.
- Stock based compensation increased by 279% as a result of granting and vesting of stock options to certain employees, directors and officers of the Company in 2015.
Research and development expenses totaled $3,038,326 for the year ended December 31, 2015 compared to $1,455,301 in 2014 (205% increase). Research and development expenses represented 46% of the Company’s operating expenses for the period and represent direct investment into commercialization efforts of the TLC-2000 therapeutic medical laser technology and development expenses of the TLC-3000 anti-cancer technology.
The net loss for the year ended December 31, 2015 was $5,225,975, which included $666,181 of net non-cash expenses (amortization, stock-based compensation expense, foreign exchange gain/loss and lease inducements). This compared to a net loss in 2014 of $2,587,542, which included $291,534 of net non-cash expenses. The Photo Dynamic Therapy (“PDT”) division represented $3,676,181 of this loss (70%). The increase in net loss is primarily due to increased investment in research and development, sales and marketing personnel and administrative personnel all related to the launch of the TLC-2000 and the commencement of a Phase Ib clinical study for Non-Muscle Invasive Bladder Cancer (“NMIBC”) expected in late 2Q2016.
Roger Dumoulin-White, President and CEO, Theralase stated that, “Theralase achieved a majority of its strategic initiatives for 2015; specifically:
- FDA 510(k) clearance and Health Canada medical device licence approval of the TLC-2000, allowing distribution of this cutting edge technology in both Canada and the United States
- Health Canada Clinical Trial Application (“CTA”) of its lead PDC, TLD-1433
- University Health Network Research Ethics Board (“UHNREB”) approval of the clinical trial
- Six (6) month accelerated stability testing of TLD-1433
The Company is currently completing the sterilization 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 re-submission of an Investigational Testing Authorization (“ITA”) to Health Canada at the beginning of June with an expected approval date in mid-June 2016. 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.
Mr. Dumoulin-White concluded that, “The Company has successfully executed on the majority of its strategic initiatives in 2015 and 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.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes patented super-pulsed laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy (“PDT”) Division researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
Additional information is available at www.theralase.com and www.sedar.com .
This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225