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HISTORIC PMA APPROVAL AND PROGRESS IN THE R&D PORTFOLIO

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SECOND QUARTER 2019 (APRIL - JUNE)

  • Net sales of non-durable goods in the quarter amounted to SEK 50.5 (42.2) million, corresponding to an increase of 20 percent in SEK and 13 percent in local currency. Total net sales (incl. durable goods) in the quarter amounted to SEK 56.4 (46.1) million, corresponding to an increase of 22 percent in SEK and 15 percent in local currency. 
  • Sales from warm perfusion represented 45 percent (43) of sales of non-durable goods. 
  • Operating income before depreciation and amortization (EBITDA) adjusted for costs for a share-based bonus program for employees outside Sweden amounted to SEK 12.1 million (10.9), corresponding to an EBITDA margin of 21 percent (24). Reported EBITDA amounted to SEK 8.1 (8.1) million, corresponding to an EBITDA margin of 14 percent (18).  
  • Operating income adjusted for the share-based bonus program was SEK 5.9 million (6.8). Reported operating income amounted to SEK 1.9 (4.0) million, after amortization and depreciation of SEK 6.1 (4.1) million.  
  • Net income amounted to SEK 2.2 (3.9) million, resulting in earnings per share of SEK 0.08 SEK (0.15). 
  • Cash flow from operating activities during the quarter amounted to SEK 21.0 (13.1) million. Cash flow from investing activities amounted to SEK -27.8 (-19.2) million. 
  • XVIVO has received Premarket approval (PMA) from the FDA for STEEN Solution™ and XPS™. The PMA approval was the first of its kind in the world. 
  • At ISHLT (International Society for Heart and Lung Transplantation), the positive results from the first six heart transplant patients from the study at Lund University Hospital were presented. 
  • The Swedish MPA has given approval to begin clinical studies with the company's new products for heart preservation. 
  • SEK 27 million shares was issued because of warrants being exercised.
  • Canada new country with XPS™. 

THE PERIOD 2019 (JANUARY - JUNE)

  • Net sales of non-durable goods in the period amounted to SEK 97.3 (80.1) million, corresponding to an increase of 21 percent in SEK and 13 percent in local currency. Total net sales (incl. durable goods) in the period amounted to SEK 104.1 (88.6) million, corresponding to an increase of 18 percent in SEK and 9 percent in local currency. 
  • Sales from warm perfusion represented 44 percent (39) of sales of non-durable goods. 
  • Operating income before depreciation and amortization (EBITDA) adjusted for costs for a share-based bonus program for employees outside Sweden amounted to SEK 20.8 million (18.0), corresponding to an EBITDA margin of 20 percent (20). Reported EBITDA amounted to SEK 11.3 (15.2) million, corresponding to an EBITDA margin of 11 percent (17).  
  • Operating income adjusted for the share-based bonus program was SEK 9.6 million (9.9). Reported operating income amounted to SEK 0.1 (7.1) million, after amortization and depreciation of SEK 11.2 (8.1) million.  
  • Net income amounted to SEK 1.9 (7.7) million, resulting in earnings per share of SEK 0.07 (0.29).  
  • Cash flow from operating activities for the period amounted to SEK 21.2 (22.3) million. Cash flow from investing activities amounted to SEK -39.5 (-30.0) million.
  • Reimbursement for the entire EVLP process obtained in France.  
  • 2 XPS™ were delivered during the period. At the end of the quarter 48 hospitals had access to either XPS™ or LS™. 

CONFERENCE CALL

CEO Magnus Nilsson will present the report in a conference call at 2 p.m. CET on Friday, July 12, 2019. Telephone UK: +44 333 300 0804 or USA: +1 631 913 1422. PIN: 15013516#

July 12, 2019
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO 



For further information please contact:

Christoffer Rosenblad, CFO, +46 735 192 159, christoffer.rosenblad@xvivoperfusion.com
Magnus Nilsson, CEO, +46 31 788 2150, magnus.nilsson@xvivoperfusion.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 and the Securities Markets Act.  The information was submitted for publication, through the agency of the contact person set out above, at 07:30 am CET on July 12, 2019.

This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.

______________________________________________________________________________________________________________________

XVIVO Perfusion AB is a medical technology company which develops solutions and systems for assessing and preserving organs outside the body and for selecting usable organs and maintaining them in optimal condition pending transplantation.
The company is headquartered in Gothenburg, Sweden, and has one office in Lund, Sweden and one office in Denver, the USA. The XVIVO share is listed on Nasdaq Stockholm and has the ticker symbol XVIVO. More information can be found on the website www.xvivoperfusion.com.
______________________________________________________________________________________________________________________

XVIVO Perfusion AB (publ), Box 53015, SE-400 14 Göteborg. Corporate identity number 556561-0424.
Tel: 46 31 788 21 50. Fax: 46 31 788 21 69.
E-mail: info@xvivoperfusion.com. Website: www.xvivoperfusion.com

Tags:

Transplantation Steen Solution xps Xvivo Perfusion Perfadex heart transplantation lung transplantation Primecc

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