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First in the world with products for all major solid organs
THIRD QUARTER 2020 (JUL – SEP)
· Net sales of non-durable goods in the quarter amounted to SEK 42.3 (50.1) million, corresponding to a decrease of 16 percent in SEK and 10 percent in local currency. Total net sales (incl. durable goods) in the quarter amounted to SEK 42.7 (54.3) million, corresponding to a decrease of 21 percent in SEK and 17 percent in local currency. The Covid-19 pandemic continued to have an impact on sales during the third quarter, but to a lower extent than in the second quarter. In the important markets the recovery, which began in the middle of the second quarter, has continued in the right direction as the pressure on intensive care has eased. Since transplantation is a life-sustaining treatment and transplants are prioritized by healthcare authorities worldwide, the company's assessment is that the long-term effect on demand for transplant products will remain unchanged.
· Sales from warm perfusion represented 41 percent (41) of sales of non-durable goods.
· Operating income before depreciation and amortization (EBITDA) amounted to SEK -11.2 (9.0) million corresponding to an EBITDA margin of -26 percent (17). During the quarter EBITDA was affected by costs associated with organizational change of SEK 5.4 million, costs for a share-based bonus program for employees outside Sweden of SEK 12.5 million and acquisition costs of SEK 2.7 million. Adjusted for these costs of a total SEK 20.5 million, the company reported an EBITDA for the quarter of SEK 9.3 (6.8) million, corresponding to a positive EBITDA margin of 22 percent (13).
· Operating income amounted to SEK -18.7 (2.3) million, after depreciation and amortization of SEK 7.4 (6.7) million. Adjusted for the above-mentioned specific costs, operating profit amounted to SEK 1.8 million (0.0).
· Net income amounted to SEK -14.7 (4.9) million, resulting in earnings per share of SEK -0.51 SEK (0.19).
· Cash flow from operating activities during the quarter amounted to SEK -1.8 (15.6) million. Cash flow from investing activities amounted to SEK -14.6 (-18,0) million. Cash flow from financing activities amounted to SEK 486.1 million (-0,1) net and is primarily explained by a directed share issue of SEK 500 million less issuance costs of SEK 12.4 million and amortization of lease liabilities of SEK 1.5 million.
· XVIVO entered into an agreement to acquire 100 percent of the shares in the Dutch medical technology company Organ Assist B.V. Organ Assist focuses mainly on developing machines and consumables for perfusion of liver and kidney. Through the acquisition, XVIVO becomes the first company in the world, within preservation and evaluation of organs, to actively conduct business in all major organ areas. The acquisition accelerates the company's strategy to become a global supplier of solutions and systems in all major organ areas. The purchase price amounted to a maximum of EUR 24 million, with an initial payment of EUR 20 million and a conditioned, additional purchase price of maximum EUR 4 million.
· The acquisition of Organ Assist was financed through a directed share issue. Investors included both existing and new shareholders, including Bure Equity AB, Swedbank Robur, Eccenovo AB (publ.), Fjärde AP-Fonden, Lannebo Fonder and Handelsbanken Fonder. The issue took place with no discount at a subscription price of SEK 236 and the company received approximately SEK 500 million. Issuance costs amounted to SEK 12.4 million.
· The first patient in the extended PrimECC® study was included.
· A reorganization, which affected the company's management team and all departments, has taken place with the aim of creating a more efficient and successful organization. The Management Team has been strengthened with a new Commercial Director, Johan Holmström and a new R&D Director Charlotte Walldal. Furthermore, the company's current CFO, Christoffer Rosenblad, has been appointed to a newly established position within XVIVO as Chief Operating Officer, COO, with effect from 1 December. The new CFO will be Kristoffer Nordström, XVIVO's current Finance Manager.
· The application period for warrant program series 2020/2022 expired on September 23 and a total of 374.000 warrants were subscribed for.
THE PERIOD 2020 (JAN – SEP)
· Net sales of non-durable goods in the period amounted to SEK 114.5 (147.5) million, corresponding to a decrease of 22 percent in SEK and 22 percent in local currency. Total net sales (incl. durable goods) in the period amounted to SEK 119.6 (158.4) million, corresponding to a decrease of 25 percent in SEK and 24 percent in local currency. The Covid-19 pandemic has had a large impact on sales and product mix during the period.
· Sales from warm perfusion represented 34 percent (43) of sales of non-durable goods.
· Operating profit before depreciation and amortization (EBITDA) amounted to SEK -9.1 million (20.3), corresponding to an EBITDA margin of -8 percent (13). Operating profit during the period was affected by costs associated with organizational change of SEK 9.9 million, cost reservation for the share-based bonus programs for employees outside Sweden of SEK 9.9 million and acquisition costs of SEK 2.7 million. Adjusted for these specific costs of a total of SEK 22.5 million, EBITDA for the period amounts to SEK 13.4 million (27.6), corresponding to an EBITDA margin of 11 percent (17).
· Operating income amounted to SEK -31.3 (2.3) million, after depreciation and amortization of SEK 22.2 (18.0) million. Adjusted for the above-mentioned specific costs, operating profit amounted to SEK -8.8 million (9.6).
· Net income amounted to SEK -24.2 (6.8) million, resulting in earnings per share of SEK -0.91 (0.26).
· Cash flow from operating activities for the period amounted to SEK 9.7 (36.7) million. Cash flow from investing activities amounted to SEK -44.3 (-57.5) million. Cash flow from financing activities amounted to SEK 484.5 million (26.2) net and is primarily explained by a directed share issue of SEK 500 million less issuance costs of SEK 12.4 million, and amortization of lease liabilities of SEK 4.5 million.
· Dag Andersson has been appointed new President and CEO. XVIVO Perfusion's founder and former CEO, Magnus Nilsson, remains as Senior Advisor to primarily work with R&D.
· Anne-Li Sigvardsson, MSc, has been appointed IP Manager (Chief Intellectual Property Officer). Andreas Wallinder, MD, PhD has been appointed Chief Medical Officer.
· During the period, the scientific journal Nature Communications published an article describing the company's heart preservation technology and showing the method is safe.
· The company's study for heart preservation prior to transplantation in Europe is complete to include the first patient.
· The further developed and more user-friendly Perfadex® Plus with Click Port has been launched worldwide.
· AKH University Hospital in Vienna, Austria, which is one of the three largest lung transplant clinics in Europe, has purchased an XPS™. An XPS™ has for the first time been delivered to a pediatric (children's) hospital in Rome, Italy. At the end of the period, 53 clinics had access to XPS, LS or LS ™.
Events after the period
• On October 1, 2020, XVIVO completed the acquisition of the total shares in the Dutch medical technology company Organ Assist B.V. The initial cash purchase price of approximately EUR 20 million has been paid and Organ Assist B.V. will be consolidated into XVIVO from October 1, 2020.
• On October 14, an Extraordinary General Meeting took place where Lars Henriksson and Lena Höglund were appointed as new members of the Board of Directors.
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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, one office in Groningen, the Netherlands and one office in Denver, 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.
This information is information that XVIVO Perfusion AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2020-10-23 07:30 CEST.