Year-end Report 1 October – 31 December 2020

“Today, we have announced the intention of filing a 510(k) application to the US FDA during 2021 for market approval for an Episealer® Patellofemoral System. This is an expansion of the clinical indications for using the Episealer® knee implants”, says Pål Ryfors, CEO Episurf Medical.

Fourth quarter 2020 compared to 2019, Group

• Gross order intake amounted to SEK 1.3m (1.2), an increase of 9%. We experienced a 21% increase in orders for Episealer® implants during the quarter with 57 (47) approved orders. Compared to Q3 2020, we experienced a decrease in the gross order intake as renewed COVID-19 restrictions had a significant negative impact on the quarter
• Order backlog amounted to SEK 1.3m (1.1), an increase of 18%
• Total income of SEK 3.1m (1.4), a growth of 118% driven by licensing income
• Group net sales increased by 15% to SEK 1.5m (1.3)
• Loss for the period amounted to SEK -16.2m (-18.7); the improved result depends on income for µiFidelity® software platform during the quarter of SEK 1.5m, and that costs during the quarter decreased, which is mainly due to SEK 0.6m lower costs for the EPIC-Knee study and cost savings in connection with COVID-19
• Earnings per share amounted to SEK -0.08 (-0.21)

Twelve months 2020 compared to twelve months 2019, Group

• Gross order intake amounted to SEK 5.6m (5.0) an increase of 11%
• 29% increase in orders for Episealer® implants during the financial year with 261 (202) approved orders
• Total income of SEK 7.0m (5.4), a growth of 30%
• Group net sales increased by 2% to SEK 5.0m (4.9) during the financial year
• Loss for the period amounted to SEK -63.9m (-69.8)
• Earnings per share amounted to SEK -0.39 (-1.04)

Significant events during the fourth quarter

• Episurf Medical carried out a directed share issue and raised SEK 66m
• Episurf Medical entered into licensing agreement of SEK 1.5m for µiFidelity® software platform
• Episurf Medical entered into a distribution agreement for France and additional markets in Asia
• Episurf Medical entered into an advisory agreement with Prof. Doctor João Espregueria-Mendes regarding establishment of the Episealer® knee technology in India and Portugal
• Data showing high implant survival rate for Episealer® were accepted for publication
• The first Episealer® surgery was performed in the US, Asia and Scotland
• First Episealer® Talus surgery in Scandinavia performed
• Episurf Medical reached milestone of 900 approved implants

Significant events after the fourth quarter

• Episurf Medical announced its intention to file a 510(k) application in the US for an Episealer® Patellofemoral System
• First Episealer® Talus surgery in the Asia-Pacific region performed
• New patents approved in Hong Kong and US for Episurf Medical
• Episurf Medical entered into distribution agreement for Australia and New Zealand
• Episealer®: Clinical results with 5-years’ follow-up data will be presented at the 3^rd World Arthroplasty Congress

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 individualised treatment alternatives. Episurf Medical’s Episealer® individualised implants and Epiguide® surgical drill guides are developed for treating localised 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 and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on 19 February 2021.

Tags: