Report on operations 2015

FOURTH QUARTER 2015 (OCT – DEC)

• Net sales in the quarter amounted to SEK 32.7 (25.5) million, corresponding to an increase of 28 percent. Net sales increased by 17 percent in local currency.
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 6.9 (3.1) million, corresponding to an EBITDA margin of 21 percent.
• Net income amounted to SEK 2.8 (0.3) million, resulting in earnings per share of SEK 0.13 (0.01). The figures are affected by amortization and depreciation of SEK 3.1 (2.6) million.
• Cash flow from operating activities was SEK 2.9 (-5.4) million.
• Net sales of non-Durable goods* in the quarter amounted to SEK 29.1 (25.5) million, corresponding to an increase of 14 percent in SEK. Sales of non-Durable goods increased by 5 percent in local currency.
• Products for warm perfusion (STEEN Solution™, the XPS™ and products related to the use of the XPS™) accounted for 40 (34) percent of total product sales.
• Three XPS™ was delivered during the quarter. One to the US and two to Europe, whereof one to the world’s second largest lung transplant clinic in Vienna, Austria.
• The China Food and Drug Administration (CFDA) approved STEEN Solution™ for marketing and clinical use in China.

THE PERIOD 2015 (JAN – DEC)

• Net sales in the period amounted to SEK 120.2 (84.7) million, corresponding to an increase of 42 percent. Net sales increased by 25 percent in local currency.
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 18.8 (11.4) million, corresponding to an EBITDA margin of 16 percent.
• Net income amounted to SEK 5.1 (5.2) million, resulting in earnings per share of SEK 0.24 (0.25) after depreciation and amortization of SEK 11.6 (3.9) million had been charged to the period.
• Cash flow from operating activities was SEK 8.6 (-4.6) million.
• Net sales of non-Durable goods* in the period amounted to SEK 106.0 (83.2) million, corresponding to an increase of 27 percent in SEK. Sales of non-Durable goods increased by 12 percent in local currency.
• Products for warm perfusion (STEEN Solution™, the XPS™ and products related to use of the XPS™) accounted for 39 (28) percent of total product sales.
• The first XPS™ was delivered to Europe. During the year a total of 4 clinics in Europe gained access to the XPS™, including the world’s second largest lung transplant clinic in Vienna, Austria.
• The United States Patent and Trademark Office approved a third patent in the “Preservation and evaluation solution” family, which means that STEEN Solution™ and the XPS™ have broader patent protection in the US.
• A strategic decision was made to apply for listing on Nasdaq Stockholm’s main market during 2016.
• The first liver transplant using STEEN Solution™ was performed in Toronto, Canada, as part of a clinical phase 1 study.

SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER

• A decision was made to apply for listing on the First North Premier segment as one step on the way to preparing the company for an application for listing on NASDAQ Stockholm’s main market.
• The company has obtained a CE mark for a patent-protected product, PrimECC®, which has been developed to prime heart-lung machines before open heart surgery. The company will expand the clinical documentation for PrimECC® through more clinical studies in 2016.
• At the time of publication of this report, 23 clinics have access to the XPS™, including 18 clinics in the US and 4 clinics in Europe.
• After the end of the quarter one XPS™ contract was signed in Europe

CONFERENCE CALL

 CEO Magnus Nilsson will present the report in a conference call at 2 p.m. CET on Thursday, February 4, 2016. Telephone: +44 (0) 1452 555566, enter code 68991296.

February 4, 2016
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO

* Durable goods are sales revenues from the XPS™.