TORONTO, ONTARIO--(Marketwired - Mar 2, 2016) - Profound Medical Corp. ("Profound" or "Company") (TSX VENTURE:PRN), a medical device company developing and commercializing a unique, minimally invasive treatment to ablate the prostate gland in prostate cancer patients, today reported financial results for the year ended December 31, 2015. Amounts, unless specified otherwise, are expressed in Canadian dollars.
"This concludes a transformative year as we completed our significant financings, transitioned to a public company and have ramped up execution of our business strategy," said Steve Plymale, CEO of Profound. "We have been building our team, preparing for commercial launch in Europe, and the initiation of our Pivotal Clinical Trial."
Corporate Highlights
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On June 4, 2015 the Company closed $28 million in financing and completed a reverse take-over and began trading on the TSX Venture Exchange.
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On July 21, 2015, Royal Philips and Profound announced the entering into a joint development agreement to support Profound's proprietary TULSA technology on Philips' Ingenia and Achieva 3T MRI systems.
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On October 15, 2015, Profound announced successful 12-month Phase I outcomes at the European Symposium on Focused Ultrasound Therapy, meeting primary endpoints. The Phase I trial demonstrated that MRI-guided TULSA provides accurate treatment planning, real-time thermal dosimetry and precise control of prostate ablation to within +/-1.3 mm, with a well-tolerated side-effect profile.
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On November 2, 2015, Profound announced the appointment of Hartmut Warnken as Vice President, International Sales, to lead commercialization efforts in Europe of the TULSA-PRO™ system commencing in 2016 (and pending certain regulatory approvals). Mr. Warnken has extensive experience in sales and marketing in the medical device technology industry.
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On November 27, 2015, Profound announced that it was named Life Science Company of the Year by Life Science Ontario (LSO).
Summary Full Year 2015 Results
The Company recorded a net loss for the year ended December 31, 2015 of $16,375,741 or $0.69 per common share, compared with a net loss of $8,204,409 or $3.79 per common share for the year ended December 31, 2014. For the year ended December 31, 2015, the net loss was attributed to the finance costs related to the listing expense of the transaction of $2,058,234, the loss on recognition of the convertible notes of $2,094,565, the interest and accretion expense of $5,625,257 largely related to acceleration of the accretion of the preferred shares at the time of their conversion to common shares, partially offset by the gain in fair value of derivatives of $2,084,652, partially offset by the gain on conversion of the Notes of $1,759,885, the ongoing R&D expenses of $5,136,848, and the G&A expenses of $6,086,049. G&A expense includes marketing expense of $2,303,034 related to the Knight loan. For the year ended December 31, 2014, the net loss was attributed to the ongoing finance costs related to the preferred shares and long-term debt, loss on fair value of derivatives of $1,639,382, the ongoing R&D expenses of $2,306,683 and G&A expenses of $2,032,074.
Expenditures for R&D for the year ended December 31, 2015 were higher by $2,830,165 compared to the year ended December 31, 2014. The increase was primarily due to the activities in preparing regulatory filings for marketing approval of TULSA-PRO in Europe and Canada, preparation for the initiation of the multi-jurisdictional Pivotal Trial, and preparation of the 12-month clinical outcomes from the 30 patient multi-jurisdictional TULSA Phase 1 safety and feasibility trial. Preparations for the Pivotal Trial include organizing the IDE submission and a Pivotal Trial in up to 15 clinical sites, designed to support a 510k submission in the United States for the TULSA-PRO system. As a result material costs increased by $2,183,077. The number of employees involved in R&D also increased during this period to support these activities resulting in salaries and benefits increasing by $628,064. These increases were offset by an increase of $132,905 in investment tax credits. In the year ended December 31, 2014, enrollment in our 30 patient multi-jurisdictional TULSA Phase 1 safety and feasibility trial was completed.
G&A expenses for the year ended December 31, 2015 were higher by $4,053,975 compared to the year ended December 31, 2014 primarily due to marketing expense of $2,303,034 representing an excess of the fair value of the Knight Loan over the amount of proceeds, and represents additional value provided to the Company as a result of the Knight relationship. The remaining increase was also due to higher salaries and benefits of $884,583, and share-based compensation of $454,400. The number of employees in G&A were higher due to the hiring of a Chief Financial Officer and other employees, and a salary increase and bonuses related to the closing of the private placement and the Transaction, as discussed above in the Overview. Professional and consulting fees in legal and accounting services also increased $160,730 as the Company prepared for the private placement and the Transaction.
Liquidity and Outstanding Share Capital
As at December 31, 2015, Profound had cash, and short-term investments of $20,522,520 compared to $406,495 as at December 31, 2014. The increase is mainly a result of cash flows provided by financing during the year. The cash flows provided by financing activities related principally to the issuance of common shares in connection with the private placement for gross proceeds of $24,008,828, the $4,000,000 proceeds from the Knight loan and the $1,500,000 proceeds from the issuance of convertible notes, reduced by transaction costs and a bank loan repayment. The cash flows provided by investing activities relate to cash acquired as part of the Transaction.
As at March 1, 2016, Profound had an unlimited number of authorized common shares with 39,473,327 common shares issued and outstanding.
For complete financial results, please see our filings at www.sedar.com and our website at www.profoundmedical.com
Conference Call Details
Profound Medical is pleased to invite all interested parties to participate in a conference call on, March 3, 2016 at 8:30 a.m. EST during which time the results will be discussed.
| Live Participant Dial In (Toll Free): 877-407-9210 |
| Live Participant Dial In (International): 201-689-8049 |
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| Replay Number (Toll Free): 1-877-660-6853 |
| Replay Number (International): 1-201-612-7415 |
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| Conference ID #: 13630480 |
About Profound Medical Corp.
Profound Medical is a Canadian medical device company that has developed a unique and minimally invasive treatment to ablate the prostate gland in prostate cancer patients. Profound's novel technology combines real-time MR imaging with transurethral therapeutic ultrasound and closed-loop thermal feedback control. It provides a highly precise treatment tailored to patient-specific anatomy and pathology. This method of prostate ablation offers short treatment times and low morbidity, allowing for fast patient recovery. The potential of this technology is currently being demonstrated in clinical trials. For more information, visit profoundmedical.com
Notice regarding forward-looking statements:
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound's technology in the treatment of prostate cancer. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of each entity. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
