STENTYS Reports 2013 Financial Results

STENTYS (FR0010949404 – STNT), a medical technology company commercializing the world’s first and only Self-Apposing^® stent to treat acute myocardial Infarction (AMI), today announced its annual results for the financial year to December 31, 2013, approved by the Board of Directors at its meeting on March 6, 2014.

• 2013 annual results

Historical activity (excluding the APPOSITION V study)

US pre-marketing (including the APPOSITION V study)

Consolidated income statement

* Audited data ** Including cost of sales and before share-based payment *** In accordance with IAS19 revision

Annual revenues up 34%
As indicated in its press release on January 23, 2014, STENTYS recorded annual revenues of €3,393.6 thousand in 2013, an increase of 34% on the previous year. This solid growth was exclusively due to sales of the Company’s products, which are marketed in Europe and the Middle East.

Further improvement in results for the Company’s historical activity

Historical activity (excluding the APPOSITION V study)
For 2013, total operating expenses (including the cost of goods sold) were up 2.9% compared to 2012, which again reflects STENTYS’ efforts to control its costs while expanding its commercial presence.

In detail, operating expense items (before share-based payment) were as follows:

• Research & Development (down 9%): Since the preclinical phase of the U.S. study was completed with the IDE approval from the FDA in 2012, the Research & Development teams have realigned their priorities to expanding the CE Mark indications, notably for the treatment of vessels that are tapered, aneurysmatic, ectatic (dilated) or of large diameter, as well as to the development of product enhancements.
• Sales & Marketing (down 1.9%): The Company is tailoring its marketing strategy to the evolution of its market globally, and participated to the cardiology conference in Dubai (GulfPCR) at the end of 2013.
• General & Administrative (up 4.9%): These costs increased in line with the Company’s development in 2013.

The operating loss on the Company’s historical activity was down 13.2% at €9,592.7 thousand in 2013, improving over 2012.

US pre-marketing (including the APPOSITION V study)
The operating expenses of €2,339.8 thousand correspond to expenditure directly associated with the APPOSITION V clinical trial, including recruitment of the U.S. clinical team, contracts with clinical research organizations, promotion of the study and market preparation.

STENTYS had 37 staff on December 31, 2013, compared to 35 on December 31, 2012.

• Solid cash position of €31.9 million

At December 31, 2013, the Company had a cash position of €31.9 million, which provides sufficient financial resources to continue its clinical and marketing development. The amount of cash consumed by operating activities was €12.3 million in 2013, compared with €9.9 million in 2012, which is primarily attributed to expenditures on the APPOSITION V study.

• 2014 outlook

STENTYS began 2014 by signing distribution agreements in Asia (Singapore, Hong Kong and Malaysia), and the Company’s commercial expansion should continue throughout the year with a further extension of the distribution network to other high-potential regions of the world, notably Latin America.

Results from several clinical studies are also expected to be announced. Final results from the APPOSITION IV clinical trial are planned for presentation in May at the EuroPCR Congress in Paris. Patient enrollment in the APPOSITION V clinical trial, which compares the STENTYS Self-Apposing stent to the Abbott Multi-Link Vision^® stent, should be completed before the end of the year. The 1-year results from APPOSITION V could then enable the Company to apply for Premarket Approval (PMA) in the United States, possibly in 2016.

Lastly, the Company should receive the CE Mark for its Sirolimus-eluting stent during the second half of 2014.

• STENTYS added to the Euronext Paris CAC PME index

Eligible for PEA-PME SME equity savings plan in France, STENTYS has been recently included in the newly-launched Euronext CAC PME index which consists of 40 French companies, only two of which are from the medical device sector. STENTYS shares were chosen using a formula based on the average daily trading volume and the free float.

• Appointment of Marie Meynadier to represent BPI-France on Board of Directors

Marie Meynadier, Chief Executive Officer of EOS Imaging a pioneer in orthopaedic 2D/3D imaging, has been appointed by BPI-France to represent the institution on STENTYS Board of Directors. Mrs. Meynadier replaces Maïlys Ferrère.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, comments: "In 2013, we made major progress in our marketing initiatives while also keeping our spending under control, thus further reducing our operating loss and reporting a solid cash position. For 2014, we are confident that we can maintain this dynamic and successfully complete numerous development projects, including the marketing of the new Sirolimus-eluting stent.”

• Upcoming financial results

STENTYS expects to publish its revenues for Q1 2014 on April 24, 2014.

About the STENTYS Self-Apposing^® Stent
The STENTYS Self-Apposing^® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients or patients with atypical artery anatomy. Its flexible, self expanding design takes the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel, in particular after an AMI as the vessel dilates and the clot dissolves. It reduces the risk of malapposition and complications associated with conventional stents in this setting. The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent is expected to receive CE Mark in H2 2014.

About STENTYS
STENTYS is developing and commercializing innovative solutions for the treatment of patients with acute myocardial infarction (AMI, or heart attack) and complex coronary artery disease. STENTYS’s Self-Apposing^® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters, particularly in the post-infarction phase, in order to prevent the malapposition problems associated with conventional stents. In the APPOSITION III clinical trial, STENTYS stents demonstrated a very low one year mortality rate among 1,000 high-risk AMI patients when compared to recent studies with conventional stents.
More information is available at www.stentys.com.

This press release contains forward looking statements about the Company’s business. Such forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which it will operate in the future which may not be accurate. Such forward-looking statements involve known and unknown risks which may cause the Company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks associated with the development and commercialization of the Company’s products, market acceptance of the Company’s products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, uncertainties related to the U.S. FDA approval process, including with respect to a pre-market approval for the Company’s BMS, slower than expected rates of patient recruitment for clinical trials, the outcome of clinical trials, and other factors, including those described in the Section 4 "Risk Factors” of the Company’s 2011 Registration Document (document de référence) filed with the Autorité des Marchés Financiers in France on August 27, 2013 under number R.13-040 as such section may be updated from time to time.

STENTYS is listed on Comp. B of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT