{"id":3193,"date":"2014-02-07T07:30:00","date_gmt":"2014-02-07T07:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/report-on-operations-2013\/"},"modified":"2014-02-07T07:30:00","modified_gmt":"2014-02-07T07:30:00","slug":"report-on-operations-2013","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/report-on-operations-2013\/","title":{"rendered":"Report on Operations 2013"},"content":{"rendered":"<div class=\"mfn-preamble\"><strong>ACCELERATED SALES GROWTH DRIVEN BY STEEN SOLUTION\u2122<\/strong><\/div>\n<p><strong><span>FOURTH QUARTER 2013 (OCT-DEC)<\/span><\/strong><\/p>\n<ul>\n<li>\n<p><span>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. <\/span><\/p>\n<\/li>\n<li>\n<p><span>Operating income before depreciation and amortization (EBITDA) amounted to SEK 3.0 (0.6) million, corresponding to an EBITDA margin of 15 percent.<\/span><\/p>\n<\/li>\n<li>\n<p><span>Net income amounted to SEK 2.4 (-0.8) million, resulting in earnings per share of SEK 0.12 (-0.04). <\/span><\/p>\n<\/li>\n<li>\n<p><span>Cash flow from operating activities was SEK 7.1 (1.7) million.<\/span><\/p>\n<\/li>\n<li>\n<p><span>STEEN Solution\u2122 and related products accounted for 21 (11) percent of total sales.<\/span><\/p>\n<\/li>\n<li>\n<p><span>The first lung transplantation using a lung treated with the STEEN Solution\u2122 method was carried out in Asia at Okayama University Hospital in Japan.<\/span><\/p>\n<\/li>\n<li>\n<p><span>Resources allocated to launch the XPS\u2122 system in Europe based on good clinical results and strong interest from clinics in Europe. XPS\u2122 facilitates the use of STEEN Solution\u2122. Announcement regarding CE marking is expected during the first quarter of 2014.<\/span><\/p>\n<\/li>\n<li>\n<p><span>Dr. Joel Cooper was appointed Medical Advisor for XVIVO Perfusion. Dr. Joel Cooper, pioneer in lung transplant surgery, will support the company&#39;s clinical development.<\/span><\/p>\n<\/li>\n<li>\n<p><span>A lawsuit was filed against Vivoline on October 11, 2013 in order to safeguard XVIVO Perfusion\u2019s rights to patents for three products invented by Professor Stig Steen.<\/span><\/p>\n<\/li>\n<\/ul>\n<p><strong><span>THE PERIOD 2013 (JAN-DEC)<\/span><\/strong><\/p>\n<ul>\n<li>\n<p><span>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. <\/span><\/p>\n<\/li>\n<li>\n<p><span>Operating income before depreciation and amortization (EBITDA) amounted to SEK 13.0 (8.3*) million, corresponding to an EBITDA margin of 19 percent.<\/span><\/p>\n<\/li>\n<li>\n<p><span>Net income amounted to SEK 8.1 million, resulting in earnings per share of SEK 0.41. <\/span><\/p>\n<\/li>\n<li>\n<p><span>Cash flow from operating activities was SEK 13.5 million. <\/span><\/p>\n<\/li>\n<li>\n<p><span>STEEN Solution\u2122 and related products accounted for 16 (11) percent of total sales.<\/span><\/p>\n<\/li>\n<li>\n<p><span>Three leading centers outside the US (Toronto, Paris and Europe&#39;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\u2019s product STEEN Solution\u2122. The results show that the centers that use STEEN Solution\u2122 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.<\/span><\/p>\n<\/li>\n<li>\n<p><span>XVIVO Perfusion entered into an agreement and began preparations for the relocation of contract manufacturing of STEEN Solution\u2122 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.<\/span><\/p>\n<\/li>\n<\/ul>\n<p><strong><span>STEEN Solution\u2122 in the United States<\/span><\/strong><\/p>\n<ul>\n<li>\n<p><span>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.<\/span><\/p>\n<\/li>\n<li>\n<p><span>All of the planned 42 + 42 patients were included during the year in the clinical NOVEL study with STEEN Solution\u2122 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\u2122 and that the trial may be expanded with new centers. Interest in STEEN Solution\u2122, the company\u2019s XPS\u2122 and participation in the NOVEL study continues to be strong.<\/span><\/p>\n<\/li>\n<li>\n<p><span>The American NOVEL study expanded to nine centers during the year.<\/span><\/p>\n<\/li>\n<li>\n<p><span>Unique collaboration between Michigan\u2019s OPO** and three transplant centers initiated in XVIVO Perfusion\u2019s US clinical trial. The aim is to increase the number of lungs that can be transplanted.<\/span><\/p>\n<\/li>\n<\/ul>\n<p><strong><span>SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER<\/span><\/strong><\/p>\n<ul>\n<li>\n<p><span>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\u2122 in order to strengthen the collaboration between transplant centers and OPO&#39;s. This collaboration is the second of its kind in the USA. <\/span><\/p>\n<\/li>\n<\/ul>\n<p><strong><span>CONFERENCE CALL <\/span><\/strong><\/p>\n<p><span>CEO Magnus Nilsson will present the report in a conference call at 2 p.m. CET on Friday, February 7, 2014. <\/span><span>Telephone: +46 8 50336434, enter code 44869671<\/span><\/p>\n<\/p>\n<p><span>February 7, 2014<br \/> Gothenburg <\/span><\/p>\n<\/p>\n<p><span>XVIVO Perfusion AB (publ)<br \/> Magnus Nilsson, CEO<\/span><\/p>\n<\/p>\n<p><span>* Comparative figures are Jan-Sep 2012 from Vitrolife Segment Transplantation added with Oct-Dec 2012 XVIVO Perfusion.<br \/> ** An OPO or Organ Procurement Organization is responsible for coordination and assessment of donated organs for organ transplantation in a region in the US. <\/span><\/p>\n<div class=\"mfn-footer\">\n<p><span>For further information please contact:<br \/><\/span><br \/><span>Magnus Nilsson, CEO, +46 31 788 21 50, <a href=\"mailto:magnus.nilsson@xvivoperfusion.com\" rel=\"nofollow\">magnus.nilsson@xvivoperfusion.com<\/a><br \/>Christoffer Rosenblad, CFO, +46 31\u00a0788 21 59, <a href=\"mailto:christoffer.rosenblad@xvivoperfusion.com\" rel=\"nofollow\">christoffer.rosenblad@xvivoperfusion.com<\/a><\/span><br \/><span>For further information on XVIVO Perfusion\u2019s business, please refer to the company\u2019s website, <a href=\"http:\/\/www.xvivoperfusion.com\" rel=\"nofollow\">www.xvivoperfusion.com<\/a><\/span><\/p>\n<p><span>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\u00a0February 7, 2014\u00a0at 8:30 a.m.<\/span><\/p>\n<p><span>This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>ACCELERATED SALES GROWTH DRIVEN BY STEEN SOLUTION\u2122 FOURTH QUARTER 2013 (OCT-DEC) Sales increased by 38 percent in local currency. Sales&#8230;<\/p>\n","protected":false},"template":"","class_list":["post-3193","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-lang-en","mfn-news-tag-mfn-regulatory","mfn-news-tag-mfn-regulatory-vpml","mfn-news-tag-mfn-report","mfn-news-tag-mfn-report-interim","mfn-news-tag-mfn-report-interim-q4"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Report on Operations 2013 - XVIVO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.xvivogroup.com\/us\/pressreleases\/report-on-operations-2013\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Report on Operations 2013 - XVIVO\" \/>\n<meta property=\"og:description\" content=\"ACCELERATED SALES GROWTH DRIVEN BY STEEN SOLUTION\u2122 FOURTH QUARTER 2013 (OCT-DEC) Sales increased by 38 percent in local currency. 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