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Interim report January – September 2013
SIGNIFICANT EVENTS IN THE THIRD QUARTER
- The company had a meeting with the FDA at which it was decided that an advisory committee meeting will be held at the beginning of 2014. This is positive since an advisory committee meeting precedes a registration decision and concludes the discussion of the documentation.
- The FDA decided that the clinics included in the study may continue to transplant lungs perfused with STEEN Solution™. At the end of the quarter, a total of 52 patients in the USA had been transplanted with lungs made available through the use of Steen Solution™ and XVIVO’s perfusion machine XPS™.
- Dr. Joel Cooper is to become XVIVO Perfusion’s Medical Advisor. Dr. Cooper was the first surgeon in the world to carry out a successful lung transplant and is internationally recognized for his groundbreaking progress in the treatment of lung disease. Dr. Cooper will bring his expertise in clinical lung transplantation and contribute to the company's clinical development.
- An agreement to transfer contract manufacturing of STEEN Solution™ was concluded during the quarter. This will initially involve non-recurring cost of around SEK 1 million, but within one year it will result in improved gross margin on the product.
THIRD QUARTER 2013 (JUL – SEP)
- Sales increased by 19 percent in local currency. Sales were the highest ever for an individual quarter and amounted to SEK 16.8 (14.4*) million, corresponding to an increase of 17 percent in SEK.
- Operating income before depreciation and amortization (EBITDA) amounted to SEK 3.8 (-1.5*) million, corresponding to an EBITDA margin of 23 percent.
- Net income amounted to SEK 1.6 million, resulting in earnings per share of SEK 0.08.
- Cash flow from operating activities was SEK -1.5 million due to increased inventory of SEK 5.3 million.
THE PERIOD 2013 (JAN – SEP)
- Sales increased by 20 percent in local currency. Sales amounted to SEK 48.9 (42.2*) million, corresponding to an increase of 16 percent in SEK.
- Operating income before depreciation and amortization (EBITDA) amounted to SEK 10.0 (7.7*) million, corresponding to an EBITDA margin of 20 percent.
- Net income amounted to SEK 5.7 million, resulting in earnings per share of SEK 0.29.
- Cash flow from operating activities was SEK 6.4 million.
SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER
- The first transplantation in Asia using STEEN Solution™ was carried out in October 2013.
- XVIVO Perfusion has decided to launch the XPS™ system in Europe in order to facilitate the use of STEEN Solution™ based on good clinical results and great interest from clinics in Europe.
- A lawsuit was filed against Vivoline on October 11, 2013 in order to safeguard XVIVO Perfusion’s rights to patents for three products invented by Professor Stig Steen.
CEO Magnus Nilsson will present the report in a conference call at 2 p.m. CET on Thursday, November 7, 2013. Telephone: +46 8 50336434, enter code 90670245
* Comparative figures for 2012 are Vitrolife’s Transplantation segment such as it was reported in Vitrolife’s reporting
For further information please contact:
Christoffer Rosenblad, CFO, +46 31 788 21 59, 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 November 7, 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.