TORONTO, May 06, 2016 (GLOBE NEWSWIRE) -- Profound Medical Corp. (“Profound” or “Company”) (TSXV:PRN), a medical device company commercializing a unique, MR guided ablation procedure for prostate care, today reported financial results for the three months ended March 31, 2016. Amounts, unless specified otherwise, are expressed in Canadian dollars and are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”).
“The First quarter of 2016 marked significant strategic and commercial milestones including establishing Profound Medical GmbH, a subsidiary of Profound Medical Inc., located in Hamburg, Germany, and hiring the first of our European Sales and Support staff. We also signed a major strategic collaboration agreement with Siemens Healthcare which will further advance the commercial launch of our technology, TULSA-PROTM, in Europe,” said Steve Plymale, CEO of Profound.
Corporate Highlights
- On January 29, 2016, Profound established Profound Medical GmbH a wholly-owned subsidiary of Profound Medical Inc.
- On February 29, 2016, Profound announced that it had entered into a strategic collaboration agreement with Siemens Healthcare GmbH, pursuant to which the companies will each invest approximately USD $2,000,000 on marketing and sales resources in support of the marketing and sale of TULSA-PROTM.
- On April 11, 2016, Profound announced that it was granted CE-Mark approval for the commercial sale of TULSA-PRO™ in Europe and in other CE Mark jurisdictions.
- On April 28, 2016, Profound announced that it has received first PO for commercial sale of TULSA-PROTM from ResoFus Alomar in Spain.
Summary First Quarter 2016 Results
The Company recorded a net loss for the three months ended March 31, 2016 of $3,836,219 or $0.10 per common share, compared with a net loss of $1,949,949 or $0.90 per common share for the three months ended March 31, 2015. For the three months ended March 31, 2016, the net loss was primarily attributed to R&D expenses of $2,475,997, SG&A expenses of $1,126,825, and the interest and accretion expense of $283,961 partially offset by the interest income of $50,564. For the three months ended March 31, 2015, the net loss was attributed to the ongoing R&D expenses of $835,201, and the SG&A expenses of $582,510, the ongoing finance costs related to the preferred shares of $287,098, the loss on recognition of the Convertible notes of $2,094,565, the interest and accretion expense of $317,469 largely related to the accretion of the preferred shares, partially offset by the gain on fair value of derivatives and convertible notes of $1,861,970, and the fair value gain on the Notes of $370,073.
Expenditures for R&D for the three months ended March 31, 2016 were higher by $1,640,796 compared to the three months ended March 31, 2015. The increase was primarily due to the activities in preparing regulatory filings for marketing approval of TULSA-PROTM 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. Profound is certified to the ISO13485:2003 standard including the Canadian Medical Devices Conformity Assessment System and CE Full Quality Assurance certification. These certifications are required as part of the Canadian Medical Device License applications. Preparations for the Pivotal Trial include organizing the IDE submission and a Pivotal Trial in at least 10 clinical sites, designed to support a 510(k) submission in the United States to provide a pathway for Class II classification for the TULSA-PROTM system. As a result material costs increased by $542,524. The number of employees involved in R&D also increased during this period to support these activities resulting in salaries and benefits increasing by $313,257. The increases were offset by reduced investment tax credits recorded in the three months ended March 31, 2016. Since becoming a public entity as of June 4, 2015, the Company does not qualify for refundable investment tax credits other than Ontario Innovation tax credits.
SG&A expenses for the three months ended March 31, 2016 were higher by $544,315 compared to the three months ended March 31, 2015, primarily due to an increase in the number of employees in SG&A, resulting in higher salaries and benefits of $122,291 and share-based compensation of $157,800. Professional and consulting fees also increased $218,340 related to recruiting fees, Board of Directors fees, and legal fees related to contracts and corporate matters.
Liquidity and Outstanding Share Capital
The Company had cash and short-term investments of $16,983,664 as at March 31, 2016 compared to $20,522,520 as at December 31, 2015. The decrease in cash and short-term investments during the three months ended March 31, 2016 is mainly a result of the cash used in operating activities and changes in working capital balances.
As at May 4, 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, May 9, 2016 at 8:30 a.m. EDT 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
Replay Number (Toll Free): 1-877-660-6853
Replay Number (International): 1-201-612-7415
Conference ID #: 13630480
About Profound Medical Corp.
Profound Medical is a Canadian medical device company that has developed a unique MR guided ablation procedure for prostate care. Profound’s novel technology combines real-time MR imaging with transurethral, robotically-driven 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. 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.