Saturday, August 8, 2020

Xvivo Perfusion publ : In the starting blocks for heart preservation and PrimECC trial

Transplant News Sharing // News from Source www.marketscreener.com

SECOND QUARTER 2020 (APRIL-JUNE)

Financial information

· Net sales of non-durable goods in the quarter amounted to SEK 28.0 (50.5) million, corresponding to a decrease of 44 percent in SEK and 46 percent in local currency. Total net sales (incl. durable goods) in the quarter amounted to SEK 30.4 (56.4) million, corresponding to a decrease of 46 percent in SEK and 47 percent in local currency. The Covid-19 pandemic has had a large impact on the sales and product mix during the quarter.

The Covid-19 pandemic has resulted in a decrease of lung transplants since intensive Care units have been concentrating on managing the pressure from Covid-19 patients requiring intensive care treatment. In the important markets, the company has seen some recovery in the US as of May and in Europe as of June.  Since transplantation is a life-sustaining treatment and transplants are prioritized by health authorities around the world. Therefore, the company believes that the long-term effect on demand for transplant products will be unchanged.

· Warm perfusion sales accounted for 37 (45) percent of the total sales of non-durable goods.
· Operating income before depreciation and amortization, EBITDA, amounted to SEK -5.5 (8.1) million, corresponding to an EBITDA margin of -18 percent (14). EBITDA during the quarter was affected by costs from organizational changes of SEK -4.5 million. Adjusted for this cost, EBITDA for the quarter amounted to SEK -1.0 (12.1) million, corresponding to an EBITDA margin of -3 percent (21).
· Operating income amounted to SEK -12.7 (1.9) million, after amortization and depreciation of SEK 7.3 (6.1) million. Adjusted for the above costs, operating income amounted to SEK -8.2 (5.9) million.
· Net income amounted to SEK -16.0 (2.2) million, resulting in earnings per share of SEK -0.60 (0.08).
· Cash flow from operating activities during the quarter amounted to SEK 2.4 (21.0) million. Cash flow from investing activities amounted to SEK -13.9 (-27.8) million.

Significant events

· Dag Andersson was appointed as a new President and CEO. XVIVO Perfusion’s founder and former CEO, Magnus Nilsson, remains time as Senior Advisor to primarily work with R&D.
· Anne-Li Sigvardsson, MSc has been appointed Chief Intellectual Property Officer. Andreas Wallinder, MD, PhD has been appointed Chief Medical Officer.
· During the quarter, the scientific journal Nature Communications published an article describing the use of XVIVO Perfusions heart preservation technology and the study results that proofs that the method is safe.
· The University Hospital AKH in Vienna, Austria, which is one of the three largest lung transplant clinics in Europe, has purchased an XPS ™.

THE PERIOD 2020 (JANUARY – JUNE)

Financial information

· Net sales of non-durable goods in the period amounted to SEK 72.2 (97.3) million, corresponding to a decrease of 26 percent in SEK and 28 percent in local currency. Total net sales (incl. durable goods) in the period amounted to SEK 76.9 (104.1) million, corresponding to a decrease of 26 percent in SEK and 28 percent in local currency. The Covid-19 pandemic has had a large impact on the sales and product mix during the period.
· Sales from warm perfusion represented 31 percent (44) of sales of non-durable goods.
· Operating income before depreciation and amortization (EBITDA) amounted to SEK 2.1 (11.3) million, corresponding to an EBITDA margin of 3 percent (11).EBITDA has been affected by costs from organizational changes of SEK -4.5 million, while the resolution of cost provisions for share-based bonus programs for employees outside Sweden contributed positively with SEK 2.5 million. EBITDA adjusted for these items amounted to SEK 4.1 (20.8) million, corresponding to an EBITDA margin of 5 percent (20).
· Operating income amounted to SEK -12.7 (0.1) million, after amortization and depreciation of SEK 14.8 (11.2) million. Adjusted for the above items, operating income amounted to SEK -10.7 (9.6) million.
· Net income amounted to SEK -9.5 (1.9) million, resulting in earnings per share of SEK -0.36 (0.07).
· Cash flow from operating activities for the period amounted to SEK 11.6 (22.1) million. Cash flow from investing activities amounted to SEK -29.7 (-39.5) million.

Significant events

· The advanced and more user-friendly Perfadex® Plus with Click Port has been launched worldwide.
· For the first time, an XPS ™ has been delivered to a pediatric hospital in Rome, Italy. At the end of the period, 53 clinics had access to XPS ™ or LS ™.
· The company’s studies for PrimECC® and heart preservation before transplantation, are ready to include the first patients in Europe. These two studies have not been able to start during the period due to clinics in Europe temporarily pausing all clinical trials during the Covid-19 pandemic.

CONFERENCE CALL

CEO Dag Andersson will present the report in a conference call at 2 p.m. CET on Friday, July 10, 2020. Telephone UK: +44 333 300 0804 or USA: +1 631 913 1422. PIN: 84626045#

For further information please contact:Christoffer Rosenblad, CFO, +46 735 192159, [email protected] Andersson, CEO, +46 31 788 2150, [email protected]
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 10, 2020.

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: [email protected] Website: www.xvivoperfusion.com

https://news.cision.com/xvivo-perfusion/r/in-the-starting-blocks-for-heart-preservation-and-primecc-trial,c3151914

https://mb.cision.com/Main/4567/3151914/1277400.pdf

(c) 2020 Cision. All rights reserved., source Press Releases – English

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