Operating expenses (including the cost of goods sold and before share-based payment) totaled €12.5 million over the year, compared with €10.2 million in 2011, representing an increase of 22%. Operating expenses (before share-based payment) were as follows:
- Cost of goods sold (11% of total operating expenses): The increase was associated with the growth in revenues and the number of stents sold over the period.
- Research & Development (23% of total operating expenses): R&D expenses held stable in 2012 while the Company successfully completed the preclinical tests to gain FDA approval for the US IDE and launched two new products, the STENTYS AC aspiration catheter and the new stent delivery system in Europe. The APPOSITION IV clinical trial costs are capitalized as per IFRS standards and will be amortized as soon as the Company begins to market its new Sirolimus-eluting stent.
- Sales & Marketing (48% of total operating expenses): The increase of 32% compared with 2011 reflects the strengthening of sales teams and marketing expenditure associated with the Company’s international expansion.
- General & Administrative (18% of total operating expenses): The increase in General and Administrative costs was limited to 7% in 2012 because the Company appropriately sized itself back in 2011 to accommodate its future growth.
STENTYS had 35 staff at 31 December 2012.
- Solid cash position
As announced on 24 January 2013, STENTYS’ cash position was €45.6 million at 31 December 2012 (versus €14.7 million a year earlier), following the successful capital increases carried out during the period. The amount of cash consumed by operating activities was €9.9 million in 2012 compared with €8.1 million in 2011.
- 2012: a pivotal year in STENTYS’ development
2012 was marked by two major events:
- In line with its guidance, the FDA approval in October 2012 for the initiation of the APPOSITION V IDE pivotal clinical trial in the United States. This trial should begin during H1 2013.
- The successful €36.3 million capital increase with rights issue carried out in Q4 2012, which has provided the Company with the means to finance the US clinical trial and to pursue its international commercial expansion.
- 2013: further international expansion
- Increased visibility in the United StatesQ1 2013 was marked by the presentation of excellent results from the APPOSITION III clinical trial at the American College of Cardiology conference in early March by Prof. Gilles Montalescot, M.D., Ph.D, Head of the Cardiac Care Unit at the Pitié Salpêtrière Hospital and Investigator of the study. These results showed the lowest mortality rate of any large heart attack trial and were reported in the US press. Furthermore, results of the APPOSITION II randomized study, which highlighted the superiority of STENTYS Self-Apposing stents compared with conventional stents, were published in the American College of Cardiology’s journal, JACC Cardiovascular Interventions.
- Geographical expansion beyond EuropeWith sales performance as evidence of the growing adoption of the STENTYS stent among European cardiologists, STENTYS is now utilizing its commercial experience to pursue expansion beyond Europe through partnerships with specialized distributors.
- Upcoming financial results