PRINCETON, N.J. & PARIS--(BUSINESS WIRE)--STENTYS (FR0010949404 – STNT), a medical technology company commercializing the world's first and only self-apposing stent to treat Acute Myocardial Infarction (AMI), today reports its half-year results for the six months to 30 June 2012, approved at the Board of Directors meeting on 30 August 2012.
- First-half results*
|
€ thousands |
30 June 2012 | 30 June 2011 |
Var % |
||||
| Revenues | 1,149.6 | 599.0 | +91.9% | ||||
|
Operating expenses prior to |
(6,276.6) | (4,631.9) | +35.5% | ||||
|
Operating loss prior to share-based payment |
(5,127.0) | (4,032.9) | +27.1% | ||||
| Net loss | (5,598.9) | (4,311.5) | +29.9% | ||||
|
*Audited, IFRS ** Includes cost of goods sold |
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Robust increase in revenues: +91.9%
As previously announced, STENTYS recorded revenues of €1,149.6 thousand during the first half of 2012. This 91.9% increase compared to the first half of 2011 reflects the growing routine use of STENTYS stents in hospitals in the 8 European countries where premarketing activities are taking place.
Operating expenses (prior to share-based payment): +35.5%
This lower increase in operating expenses relative to the increase in revenues is the result of ongoing strict spending controls whilst investments in strategic activities continue (US regulatory activities, new products, presence at medical conferences).
Research & Development costs increased 33.6% over the period, totaling €1,614 thousand, corresponding to the development of new products and to the preparation of the FDA file. Sales & Marketing costs increased by 43.5% to €3,058 thousand. These costs reflect a strengthening of the Company’s sales activity, including an expansion of the sales team and a major presence at cardiology conferences such as EuroPCR in Paris. General & Administrative costs remained stable at €977 thousand, compared to €979 thousand a year earlier. STENTYS currently has a headcount of 31 staff.
- Cash position: solid balance-sheet
At 30 June 2012, STENTYS had a cash position of €16.7 million.
- Recent events and outlook
In the first half of 2012, some major strategic milestones were reached. In particular, the Company announced excellent 30-day results for the APPOSITION III clinical trial on 1,000 heart attack patients, in which the rate of Major Adverse Cardiac Events (MACE) and death for the STENTYS Self-Apposing® stent was substantially lower than pooled results from recent trials with conventional stents in this patient population. The APPOSITION IV clinical trial, which will compare the new STENTYS Self-Apposing® Sirolimus-eluting stent to Medtronic’s drug-eluting stent, began at the end of June. Moreover, the Company expanded its commercial product offering with the launch of a thrombectomy device.
Additional announcements are expected during the second half of the fiscal year, including the planned presentation of 12-month interim results for the APPOSITION III clinical trial at the annual TCT congress in the United States (US) in October. Furthermore, the Company anticipates obtaining Food and Drug Administration (FDA) clearance to carry out the APPOSITION V clinical trial in the US.
Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, concludes: “The first-half results are in line with our expectations and reflect our progress over the first six months of the year: important advancements in our strategy coupled with strict cash management. We are in an excellent position to maintain this momentum over the second half.”
- Upcoming financial results
Revenues for the 3rd quarter of 2012 will be published on 6 November 2012.
About STENTYS:
Based in Princeton, N.J., and Paris, Stentys has developed a new generation of stents to treat acute myocardial infarction (AMI). Founded by Jacques Séguin, M.D., Ph.D., and Gonzague Issenmann, STENTYS has begun the marketing of its flagship products in a number of European countries. Its self-apposing stents adapt to the anatomic changes of the arteries in the post-infarction phase and thus prevent the malapposition problems associated with conventional stents. STENTYS stents have shown a very low one-month mortality rate amongst 1,000 high-risk AMI patients in the APPOSITION III clinical trial. More information is available at www.stentys.com.
This announcement is not an offer for sale of securities in the United States. The securities referred to herein have not been offered or sold in the United States and may not be offered or sold in the United States of America, except pursuant to a registration statement under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or pursuant to an exemption from registrations thereunder. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act.
STENTYS is listed on Compartment C of the NYSE Euronext Paris
ISIN:
FR0010949404 – Ticker: STNT