Year-end report 1 October – 31 December 2018
“In 2018, Episurf has enjoyed positive trends in almost every aspect of its operations, and in several of our regions we can say with confidence that we have established commercial businesses. By the fourth quarter of 2018, Episealer® implant orders were arriving at a rate of one per working day, and show every sign of continuing to accelerate.
The order book amounted to SEK 1.5 million during the fourth quarter 2018, representing an increase of 64% compared to the fourth quarter of 2017. The development is driven by the German market where the growth in the fourth quarter 2018 amounts to about 187% compared to the fourth quarter of 2017.
Despite the positive development above, our growing order book still only scratches the surface of the potential for Episurf’s products… The establishment of a larger clinical pipeline and the future flow of results from these studies are critical success factors for growth. When summarizing the clinical studies that are ongoing, or are about to start in the near future, it adds up to about 350 patients involved in various clinical studies of the Episealer® technology. In our opinion, this is a very strong figure”, says Pål Ryfors CEO.
Fourth quarter 2018 compared to 2017, Group
» Gross order intake amounted to SEK 1.5m (0.9), an increase of 62.7%
» Order backlog amounted to SEK 1.2m (0.9)
» 67.7% increase in orders for Episealer® knee implants during the quarter with 60 (36) approved orders
» Group net sales increased by 24.3% to SEK 1.1 m (0.9)
» Loss before tax amounted to SEK –15.4m (–15.5)
» Earnings per share amounted to SEK –0.49 (–0.51)
Significant events during the fourth quarter
» Episurf Medical announced that the company had received approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to initiate a clinical study on the Episealer® knee implant in the United States
» Episurf Medical executed a directed share issue, raising SEK 13.2m. Through the directed share issue, the company gained a US shareholder among the largest shareholders and several existing shareholders increased their holdings
» Niles Noblitt was appointed Senior Advisor to Episurf Medical
» Episurf Medical announced the start of a new investigator-initiated clinical study conducted by Prof. H. Vandenneucker at the University hospital in Leuven, Belgium
» Clinical outcome for Episealer® was presented presented at the annual meeting of the Danish Orthopaedic Society (DOS) in Copenhagen in October
» New Chinese and US patent approvals for Episurf Medical
» Episurf Medical was informed about the intention of its largest shareholder Serendipity Ixora AB to wind-up its operations and in conjunction thereto distribute its holdings of Episurf shares to its shareholders
Significant events after the fourth quarter
» Episurf Medical announced the start of a comparative investigator-initiated clinical study performed at the Julius Wolff Institute, Charité University Hospital, Berlin
For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@episurf.com
Veronica Wallin, CFO, Episurf Medical
Tel:+46 (0) 700 37 48 95
Email: veronica.wallin@episurf.com
About Episurf Medical
Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalised treatment alternatives. Episurf Medical’s Episealer® personalised implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.
This information is information that Episurf Medical 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 person set out above, at 08.30 CET on 8 February 2019.
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