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XVIVO Perfusion AB (publ) Report on Operations 2017
FOURTH QUARTER 2017 (OCT – DEC)
• Net sales of non-durable goods in the quarter amounted to SEK 39.4 (34.6) million, corresponding to an increase of 14 percent in SEK. Sales of non-durable goods increased by 21 percent in local currency. Net sales in the quarter amounted to SEK 41.6 (38.4) million, corresponding to an increase of 8 percent. The increase corresponds to 14 percent in local currency.
• Operating income before depreciation and amortization (EBITDA), excluding items affecting comparability, amounted to SEK 9.1 (6.7) million, corresponding to an EBITDA margin, excluding items affecting comparability, of 22 percent. Items affecting comparability of SEK 0.5 (3.1) million, related to the acquisition and integration of Vivoline, have been charged against the quarter. EBITDA amounted to SEK 8.6 (3.6) million, corresponding to an EBITDA margin of 21 percent.
• Operating income amounted to SEK 4.7 (0.0) million, after amortization and depreciation of SEK 3.8 (3.6) million.
• Net income amounted to SEK 5.6 (-0.6) million, resulting in earnings per share of SEK 0.21 (-0.02).
• Cash flow from operating activities was SEK 7.9 (-6,2) million.
• Warm perfusion sales from non-durable goods (STEEN Solution™, products and services related to the use of the XPS™ and LS™) accounted for 43 (38) percent of the total sales of non-durable goods.
• Reimbursement codes obtained for doctor´s time during EVLP procedure. As of January 1, 2018, hospitals in the US will be able to use three CPT codes to obtain reimbursement for doctors’ time spent using the XPS for an EVLP (Ex Vivo Lung Perfusion) procedure. The new codes will also simplify the reimbursement process for the hospitals.
• During the quarter, XVIVO Perfusion has installed the first XPS™ in China. The purpose is to start an EVLP (Ex Vivo Lung Perfusion)-study at Shanghai Pulmonary Hospital. The study is designed to complement existing EVLP data, with Chinese data.
THE PERIOD 2017 (JAN – DEC)
• Net sales of non-Durable goods in the period amounted to SEK 141.0 (122.5) million, corresponding to an increase of 15 percent in SEK and local currencies. Net sales in the period amounted to SEK 148.3 (138.2) million, corresponding to an increase of 7 percent in both SEK and local currencies.
• Operating income before depreciation and amortization (EBITDA), excluding items affecting comparability, amounted to SEK 24.8 (26.4) million, corresponding to an EBITDA, excluding items affecting comparability, margin of 17 percent. Items affecting comparability of SEK 2.8 (10.3) million, related to the acquisition and integration of Vivoline, have been charged against the period. EBITDA amounted to SEK 22.0 (16.0) million, corresponding to an EBITDA margin of 15 percent.
• Operating income amounted to SEK 7.1 (2.7) million, after amortization and depreciation of SEK 14.9 (13.2) million.
• Net income amounted to SEK 6.3 (1.5) million, resulting in earnings per share of SEK 0.25 (0.07).
• Cash flow from operating activities was SEK 22.2 (12.6) million.
• Warm perfusion sales from non-durable goods (STEEN Solution™, products and services related to the use of the XPS™ and LS™*) accounted for 35 (32) 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.
• 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 period. 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).
• 6 XPS™ and LS™ were delivered during the period. China, Australia, the Netherlands and Portugal were new countries that now have access to an XPS™ or LS™. At the end of the period 47 clinics had access to the XPS™ or LS™.
CEO Magnus Nilsson will present the report in a conference call at 2 p.m. CET on Monday, February 12, 2018. Telephone UK: +44 (0) 203 139 4830 or USA: +1 718 873 9077, enter code 20105534#.
February 9, 2018
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO
For further information please contact:
Christoffer Rosenblad, CFO, +46 735 192159, firstname.lastname@example.org
Magnus Nilsson, CEO, +46 31 788 2150, email@example.com
For further information on XVIVO Perfusion’s business, please refer to the company’s website, www.xvivoperfusion.com
This information is information that Xvivo Perfusion AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 am CET on February 9, 2018.
This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.