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Report on Operations 2013

Report on Operations 2013

ACCELERATED SALES GROWTH DRIVEN BY STEEN SOLUTION™

FOURTH QUARTER 2013 (OCT-DEC)

  • Sales increased by 38 percent in local currency. Sales were the highest ever for an individual quarter and amounted to SEK 20.0 (14.7) million, corresponding to an increase of 36 percent in SEK.

  • Operating income before depreciation and amortization (EBITDA) amounted to SEK 3.0 (0.6) million, corresponding to an EBITDA margin of 15 percent.

  • Net income amounted to SEK 2.4 (-0.8) million, resulting in earnings per share of SEK 0.12 (-0.04).

  • Cash flow from operating activities was SEK 7.1 (1.7) million.

  • STEEN Solution™ and related products accounted for 21 (11) percent of total sales.

  • The first lung transplantation using a lung treated with the STEEN Solution™ method was carried out in Asia at Okayama University Hospital in Japan.

  • Resources allocated to launch the XPS™ system in Europe based on good clinical results and strong interest from clinics in Europe. XPS™ facilitates the use of STEEN Solution™. Announcement regarding CE marking is expected during the first quarter of 2014.

  • Dr. Joel Cooper was appointed Medical Advisor for XVIVO Perfusion. Dr. Joel Cooper, pioneer in lung transplant surgery, will support the company's clinical development.

  • 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.

THE PERIOD 2013 (JAN-DEC)

  • Sales increased by 25 percent in local currency. Sales amounted to SEK 68.9 (56.9*) million, corresponding to an increase of 21 percent in SEK.

  • Operating income before depreciation and amortization (EBITDA) amounted to SEK 13.0 (8.3*) million, corresponding to an EBITDA margin of 19 percent.

  • Net income amounted to SEK 8.1 million, resulting in earnings per share of SEK 0.41.

  • Cash flow from operating activities was SEK 13.5 million.

  • STEEN Solution™ and related products accounted for 16 (11) percent of total sales.

  • Three leading centers outside the US (Toronto, Paris and Europe's largest lung transplant center in Vienna) presented excellent clinical data at the ISHLT conference in April on 112 patients with the use of XVIVO Perfusion’s product STEEN Solution™. The results show that the centers that use STEEN Solution™ have been able to save many lungs that were initially deemed unusable. The lungs were transplanted into patients in need, and the results were at least as good as for lungs initially deemed acceptable.

  • XVIVO Perfusion entered into an agreement and began preparations for the relocation of contract manufacturing of STEEN Solution™ during the year. This initially involved a non-recurring cost of SEK 0.6 million during the year, but within one year it will result in improved gross margin on the product.

STEEN Solution™ in the United States

  • The company had a meeting with the FDA at which it was decided that an advisory committee meeting will be held during the first quarter of 2014. This is positive since an advisory committee meeting usually precedes a registration decision and concludes the discussion of the documentation.

  • All of the planned 42 + 42 patients were included during the year in the clinical NOVEL study with STEEN Solution™ in the US and the clinical results are still good. The FDA decided that the clinics participating in the study may continue to transplant lungs perfused with STEEN Solution™ and that the trial may be expanded with new centers. Interest in STEEN Solution™, the company’s XPS™ and participation in the NOVEL study continues to be strong.

  • The American NOVEL study expanded to nine centers during the year.

  • Unique collaboration between Michigan’s OPO** and three transplant centers initiated in XVIVO Perfusion’s US clinical trial. The aim is to increase the number of lungs that can be transplanted.

SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER

  • Barnes Jewish Hospital in St Louis becomes the tenth transplant center to participate in the American NOVEL trial. The connected OPO, Mid-America Transplant Services, has invested in an XPS™ in order to strengthen the collaboration between transplant centers and OPO's. This collaboration is the second of its kind in the USA.

CONFERENCE CALL

CEO Magnus Nilsson will present the report in a conference call at 2 p.m. CET on Friday, February 7, 2014. Telephone: +46 8 50336434, enter code 44869671

February 7, 2014
Gothenburg

XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO

* Comparative figures are Jan-Sep 2012 from Vitrolife Segment Transplantation added with Oct-Dec 2012 XVIVO Perfusion.
** An OPO or Organ Procurement Organization is responsible for coordination and assessment of donated organs for organ transplantation in a region in the US.

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