Interim report January - June 2013
US study has full number of patients and good clinical results presented for patients outside the USA
SIGNIFICANT EVENTS IN THE SECOND QUARTER
• All the planned 42 + 42 patients have now been included in the clinical study of STEEN Solution™ in the USA and the clinical results are very promising.
• At the ISHLT conference in April, three leading clinics outside the USA (Toronto, Paris and Europe’s largest lung transplant clinic in Vienna) presented very good clinical data for 112 patients using XVIVO Perfusion’s product STEEN Solution™. The results show that by using STEEN Solution™ the clinics were able to save many lungs that had initially been assessed as unusable. The lungs were transplanted into patients in need, and the results were at least as good as for lungs initially deemed acceptable.
• During the quarter, the company submitted its response to the FDA’s supplementary questions regarding the application for marketing approval of STEEN Solution™ on the US market. The FDA is expected to notify its decision in the third quarter.
• At the end of June a total of 47 patients in the USA had been transplanted with lungs made available through the use of Steen Solution™ and XVIVO’s perfusion machine XPS™.
FIRST HALF (JAN-JUN 2013)
• Sales increased by 21 percent in local currency. Sales amounted to SEK 32.1 (27.8*) million, corresponding to an increase of 15 percent in SEK.
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 6.1 (9.2*) million, corresponding to an EBITDA margin of 19 percent.
• Net income amounted to SEK 4.1 million, resulting in earnings per share of SEK 0.21.
• Cash flow from operating activities was SEK 7.9 million.
SECOND QUARTER (APR – JUN 2013)
• Sales increased by 18 percent in local currency. Sales amounted to SEK 15.8 (14.0*) million, corresponding to an increase of 12 percent in SEK.
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 2.4 (4.2*) million, corresponding to an EBITDA margin of 15 percent.
• Net income amounted to SEK 1.7 million, resulting in earnings per share of SEK 0.09.
• Cash flow from operating activities was SEK 3.9 million.
CEO Magnus Nilsson will present the report in a conference call at 2 p.m. CET on Thursday, July 11, 2013.
Telephone: +46 8 50336434 or +44 (0)20 1452 555566, enter code 98290392
* Comparative figures for 2012 are Vitrolife’s Transplantation segment such as it was reported in Vitrolife’s reporting
For further information please contact:
Magnus Nilsson, CEO, tel: 46 31 788 21 50, e-mail: email@example.com
Christoffer Rosenblad, CFO, tel: 46 31 788 21 59, e-mail: firstname.lastname@example.org
For further information on XVIVO Perfusion’s business, please refer to the company’s website, www.xvivoperfusion.com
Xvivo Perfusion is required to publish the information in this press release in accordance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. The information was submitted for publication on July 11, 2013 at 8:30 a.m.
This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.
XVIVO Perfusion AB is a medical technology company which develops solutions and systems for assessing and preserving organs outside the body and for selecting usable organs and maintaining them in optimal condition pending transplantation.
The company is headquartered in Gothenburg, Sweden, and has one office in the USA. The Xvivo share is listed on NASDAQ OMX First North and has the ticker symbol XVIVO. More information can be found on the website www.xvivoperfusion.com. The Certified Adviser is Redeye, www.redeye.se.
XVIVO Perfusion AB (publ), Box 53015, SE-400 14 Göteborg. Corporate identity number 556561-0424.
Tel: 46 31 788 21 50. Fax: 46 31 788 21 69.
E-mail: email@example.com. Website: www.xvivoperfusion.com