XVIVO Perfusion (publ) Interim Report January – September 2017

THIRD QUARTER 2017 (JUL – SEP)

• Net sales of non-durable goods in the quarter amounted to SEK 31.6 (29.1) million, corresponding to an increase of 8 percent in SEK. Sales of non-durable goods increased by 11 percent in local currency. Net sales in the quarter amounted to SEK 32.3 (31.7) million, corresponding to an increase of 2 percent. The increase corresponds to 4 percent in local currency.  
• Operating income before depreciation and amortization (EBITDA), excluding items affecting comparability, amounted to SEK 4.4 (5.4) million, corresponding to an EBITDA margin of 14 percent. Items affecting comparability of SEK 0.4 (2.7) million, related to the acquisition and integration of Vivoline, have been charged against the quarter. EBITDA amounted to SEK 4.1 (2.7) million, corresponding to an EBITDA margin of 13 percent.
• Operating income amounted to SEK 0.4 (-0.7) million, after amortization and depreciation of SEK 3.7 (3.5) million was charged against the quarter. 
• Net income amounted to SEK -0.4 (-0.6) million, resulting in earnings per share of SEK -0.01 (-0.02).  
• Cash flow from operating activities was SEK 7.6 (5.4) million.
• Warm perfusion sales from non-durable goods (STEEN Solution™, products and services related to the use of the XPS™ and LS™*) accounted for 30 (29) percent of the total sales of non-durable goods. 
• Inclusion of all 220 (110 + 110) patients is now completed in the NOVEL study which is being carried out in the US on STEEN Solution™ and XPS™. This clinical study will form the basis of the company’s PMA (Pre-market Approval) application to the FDA. STEEN Solution™ and XPS™ have already been approved for sales in the US under an HDE (Humanitarian Device Exemption) approval.  
• Recruitment is completed for the PrimECC® study at Sahlgrenska University Hospital. The study intends to expand the clinical documentation for PrimECC® and included a total of 80 (40 + 40) patients.  
• The first clinical heart transplant using the heart preservation technology developed by XVIVO´s partner Professor Stig Steen was performed during the quarter. His research has resulted in a heart preservation technology that makes it possible to transport and store the donor heart in a more optimized way than before. Earlier animal experiments have shown that the method has the potential to extend the time that the heart is stored outside the body (Ex Vivo).

 

THE PERIOD 2017 (JAN – SEP)

• Net sales of non-Durable goods in the period amounted to SEK 101.6 (88.0) million, corresponding to an increase of 15 percent in SEK. Sales of non-Durable goods increased by 13 percent in local currency. Net sales in the period amounted to SEK 106.8 (99.8) million, corresponding to an increase of 7 percent. The increase corresponds to 4 percent in local currency.  
• Operating income before depreciation and amortization (EBITDA), excluding items affecting comparability, amounted to SEK 15.7 (19.7) million, corresponding to an EBITDA, excluding items affecting comparability, margin of 15 percent. Items affecting comparability of SEK 2.3 (7.3) million, related to the acquisition and integration of Vivoline, have been charged against the period. EBITDA amounted to SEK 13.4 (12.4) million, corresponding to an EBITDA margin of 13 percent.
• Operating income amounted to SEK 2.4 (2.7) million, after amortization and depreciation of SEK 11.1 (9.7) million was charged against the period. 
• Net income amounted to SEK 0.7 (2.1) million, resulting in earnings per share of SEK 0.03 (0.09).  
• Cash flow from operating activities was SEK 14.3 (18.7) million.
• Warm perfusion sales from non-durable goods (STEEN Solution™, products and services related to the use of the XPS™ and LS™*) accounted for 32 (31) percent of the total sales of non-Durable goods. 
• A Private Placement was fully subscribed by the Third AP Fund, Norron, Swedbank Robur and the Fourth AP Fund and it raised approximately SEK 181 million before issue costs. 
• Two XPS™ were sold during the period; one XPS™ to Australia and one XPS™ to the Netherlands. Both countries are new countries with an XPS™. At the end of the period 45 clinics had access to the XPS™ or LS™.

CONFERENCE CALL 

CEO Magnus Nilsson will present the report in a conference call at 2 p.m. CET on Friday, October 27, 2017. Telephone UK: +44 (0) 203 139 4830 or USA: +1 718 873 9077, enter code 20105534#.

October 27, 2017
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO 

* Vivoline’s EVLP machine.