Continuing growth – now on our own
FOURTH QUARTER
- Sales increased by 10 percent in local currency. Sales were the highest ever for an individual quarter and amounted to SEK 14.7 (13.7*) million, corresponding to an increase of 7 percent in SEK.
- Operating income before depreciation and amortization (EBITDA) amounted to SEK 0.6 (2.5*) million. This includes one-time expenses of SEK 2.7 million. EBITDA excluding one-time expenses amounted to SEK 3.3 million, corresponding to an EBITDA margin of 22 percent.
- Net income amounted to SEK -0.8 million, which gave earnings per share of SEK -0.04.
- Cash flow from operating activities was SEK 1.7 million.
- On October 1, 2012 XVIVO Perfusion was distributed to Vitrolife’s shareholders and XVIVO Perfusion’s share was listed on NASDAQ OMX First North. Trade in the share began on October 8.
- During November XVIVO Perfusion obtained sales approval for STEEN Solution™ in Canada. The first commercial order of STEEN Solution™ was invoiced to Canada during December.
- In October the FDA came back with supplementary questions regarding the application for marketing approval of STEEN Solution™ on the American market. These questions have been processed and answered.
- The clinical study in the USA is proceeding according to plan, with good clinical results. 32 out of 42 patients have received transplants.
- There continues to be a great deal of interest from clinics in the USA.
- Two further lawsuits have been filed in the USA against Vitrolife’s American subsidiary with regard to Perfadex. As the products were sold before the distribution of XVIVO Perfusion, XVIVO Perfusion is not liable to pay damages and Vitrolife will also handle the lawsuits in the future.
FULL YEAR PRO FORMA*
- Sales increased by 18 percent in local currency. Sales pro forma* for 2012 were SEK 56.9 (48.1*) million. This corresponds to sales growth of 18 percent in SEK.
- Operating income before depreciation and amortization (EBITDA) pro forma* amounted to SEK 8.3 (20.8*) million. The EBIDTA margin was 15 percent. This includes one-time expenses of SEK 8.6 million. EBITDA excluding one-time expenses amounted to SEK 16.9 million, corresponding to an EBITDA margin of 30 percent.
- An application for sales approval of STEEN Solution™ in the USA was submitted in July to the US Food and Drug Administration, FDA. In October the FDA came back with supplementary questions, which were processed and answered.
- Two further lawsuits have been filed in the USA against Vitrolife’s American subsidiary with regard to Perfadex. As the products were sold before the distribution of XVIVO Perfusion, XVIVO Perfusion is not liable to pay damages and Vitrolife will also handle the lawsuits in the future.
IMPORTANT EVENTS AFTER THE END OF THE YEAR
- Storage and distribution of products for Europe/Asia have been taken over by company management.
- At the beginning of February, 2013 the company was again contacted by the FDA, who gave notification that a few further questions would follow. The FDA will now have a new seventy-fived day period to evaluate Xvivo’s answers to the additional questions.
February 19, 2013
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO
* XVIVO Perfusion pro forma 2012 is the income statement for Vitrolife’s Transplantation segment for the period January to September 2012, such as it was reported in Vitrolife’s reporting, with the addition of XVIVO Perfusion’s income statement for the period October to December 2012. Comparative figures for 2011 are Vitrolife’s Transplantation segment such as it was reported in Vitrolife’s reporting.