Opsens reports 2014 results
Quebec City, Quebec, November 25, 2014 – Opsens Inc. (“Opsens”) (TSXV:OPS) today released results for the year ended August 31, 2014.
Latest Highlights for Opsens
- Receipt of CE marking allowing Opsens to sell the OptoWire and OptoMonitor in Europe. The OptoWire and OptoMonitor are Opsens’ products developed for the measurement of Fractional Flow Reserve (“FFR”) in patients with coronary artery disease;
- Receipt of Shonin approval from the Japanese Ministry of Health, Labour and Welfare to start commercialization of Opsens’ FFR products in the Japanese market, releasing a $1 million milestone payment from our Japanese partner and distributor;
- Filing of FFR products for premarket 510(k) notification with the U.S. Food and Drug Administration (“FDA”);
- First clinical work on humans – 27 patients successfully diagnosed using Opsens’ FFR products.
Highlights for the year
- Opsens grants Abiomed US$6-million license;
- Opsens completes $8.5 million equity financing;
- Opsens named to the 2014 TSX Venture top 50® among the top Canadian Technology and Life Sciences companies;
- Opsens named as one of Canada’s fastest growing technology companies in the Deloitte Technology Fast 50™.
Regulatory Approval – Limited Market Release
Our FFR products are ready to enter the market. “We have secured regulatory clearance for Japan and Europe and signed distribution agreements for Japan, Korea and Taiwan. Medical instrumentation is lead by trendsetters, physicians who often work in highly regarded, well-known institutions and adopt technologies early. In that perspective, we will begin our pre-commercialization phase with a limited number of institutions in Europe and Japan. We are confident this limited market release approach represents the best way for Opsens to enter into the FFR market“, stated Louis Laflamme, President and Chief Executive Officer of Opsens.
Next target, the U.S.
While we are starting to roll out our plan to commercialize our FFR products in Europe and Japan, we are expecting 510(k) clearance for the U.S., which will open the doors to the world’s most significant FFR market.
Opsens to Continue Investigational Testing in Patients
Following on the successful use of Opsens’ FFR products in 27 patients with coronary artery disease undergoing an angiogram, Opsens plans to continue enrollment of up to 70 patients to expand on the data available for its FFR products. “Clinical data gathered with this study will serve documenting the usability, functionality and safety of our OptoWire as well as our OptoMonitor,” said Claude Belleville, Vice President Medical.
Strong Financial Position for Successful Commercialization of its FFR Products
In the last fiscal year, Opsens has been preparing and is continuing preparation for the important commercialization phase of its FFR products. In order to successfully penetrate the FFR market, Opsens has strengthened its financial position through an $8.5 million financing and capitalized on its work with long-term partner Abiomed by granting a US$6 million licence.
As at August 31, 2014, Opsens had $10 million in cash and, in addition, held milestone payments receivables from partners for a total of $5.5 million, giving the Company the flexibility to implement a rational yet ambitious plan to launch its FFR products while supporting activities in other sectors
Opsens aims to become a key player in the guidewire FFR market with the OptoWire, a nitinol-based optical guidewire for FFR. The OptoWire provides intra-coronary blood pressure measurements with unique, patented optical pressure guidewire technologies. It is immune to adverse effects related to blood contact, and allows easy and reliable connectivity that leads to reliable FFR measurement in extended conditions of usage. The OptoWire is also designed to provide cardiologists with a guidewire delivering optimized performance to navigate coronary arteries and reach blockages with ease. Based on industry sources, the FFR market represented over US$250 million in sales in 2013 and is expected to reach US$1 billion in the medium-term. Opsens is confident that it is well positioned to capitalize on this significant growth opportunity.
We are eagerly anticipating the release of our FFR products as we are confident that their distinctive features will allow Opsens to take a significant share in this fast-growing FFR market,” said Louis Laflamme, President and CEO of Opsens.
Financial Results – Year Ended August 31, 2014
In the fourth quarter ending August 31, 2014, sales reached $1,804,000 compared with $1,451,000 for the same period a year ago, an increase of $353,000. Net loss was significantly reduced from $1,076,000 in the fourth quarter of 2013 to $549,000 in the comparative quarter this year.
Opsens’ revenues were lower for the year ended August 31, 2014 at $6,788,000, compared with $7,526,000 for 2013. The decrease in revenues is explained by fewer orders placed during the year by a large customer. This was partially offset by the installation of sensor systems from the 48-well contract from an oil and gas producer of SAGD oil sands project in Alberta, by increased revenues in the industrial field resulting from significant orders received from two existing customers and by licensing revenues arising from the Abiomed agreement. Net loss for fiscal year 2014 was $3,099,000 compared with a net loss of $2,366,000 for the same period last year. The increase in net loss mainly reflects the decrease in the gross margin, higher marketing expenses explained by higher headcount, higher advertising and tradeshows expenses and a negative variation in the change in fair value of embedded derivative.
|In thousands of Canadian dollars, except for information per share||
|Cost of sales||4,398||4,780|
|Change in fair value of embedded derivative||102||(17)|
|Net loss and comprehensive loss||(3,099)||(2,366)|
|Net loss per share – Basic||(0.06)||(0.05)|
|Net loss per share – Diluted||(0.06)||(0.05)|
About Opsens Inc. (www.opsens.com)
Focusing on two main growth markets, FFR in medical instrumentation and oil and gas, Opsens develops, manufactures and installs systems to measure pressure, temperature and others parameters using fiber optic sensing technologies. These systems are designed around patented technologies that are effective and durable in extreme conditions.
Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For further information, please contact:
Thierry Dumas, CPA, CA, Chief Financial Officer, 418.682.9996
Louis Laflamme, CPA, CA, Chief Executive Officer, 418.682.9996