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Implantica publishes Interim Report Q4, January-December 2020

25.02.2021
 | Inside information

“The extraordinary 3-year results of our pivotal RefluxStop™ clinical trial was the highlight of the fourth quarter, with patient data supporting that RefluxStop™ has the attributes to cause a paradigm shift in acid reflux treatment.”
- Peter Forsell, CEO and Founder of Implantica

Significant events during the fourth quarter, 2020

  • Implantica’s RefluxStop™ trial showed exceptional three-year follow-up results. None of the patients in the study were in need of regular daily use of PPIs (proton-pump inhibitors), which were taken by all before surgery.
  • Implantica completed a pre-submission to the U.S. Food and Drug Administration (FDA) for RefluxStop™.
  • In executing its commercialisation strategy, Implantica recruited additional sales representatives in Germany.
  • Surgical webinars were launched to facilitate surgeon outreach and training during Covid-19.
  • A registry study has been prepared and is ready to be launched including a web-based data collection system. The registry will support the sales efforts in Germany, Switzerland and the UK in order to collect standard of care data for RefluxStop™.

Significant events after the end of the reporting period

  • Implantica will start selling in the UK with reimbursement and is now reinforcing the sales organization in the UK.
  • In Germany, Implantica has received our own Operation and Procedure Classification System (OPS) code and a reimbursement Diagnosis Related Group (DRG) for RefluxStop™. This is a milestone in Germany.
  • Implantica had two meetings with the FDA. After the initial pre-submission meeting for RefluxStop™, the FDA requested a second follow-up meeting with their surgical expertise. The next step will most likely be a pre-submission supplement leading to a third meeting.
  • Applications for regulatory approval of RefluxStop™ are ongoing in 30 countries around the world in parallel.

September – December 2020

  • Net sales amounted to TEUR 26 (7)
  • Operating loss (EBIT) increased to TEUR 3,350 (1,080) 
  • Loss after tax amounted to TEUR 3,150 (1,203)
  • Basic and diluted loss per Class A share amounted to EUR 0.05 (0.03)
  • Liquid funds as at the end of the period amounted to MEUR 97.5
  • No interest-bearing debt at end of the period 

January – December 2020

  • Net sales amounted to TEUR 152 (28)
  • Operating loss (EBIT) increased to TEUR 10,641 (4,570) driven by listing costs 
  • Loss after tax amounted to TEUR 10,277 (4,805)
  • Basic and diluted loss per Class A share amounted to EUR 0.20 (0.11)
  • Cash outflow from operating activities amounted to TEUR 10,364 (3,573) with listing costs being the key driver

Implantica will hold a telephone conference on February 25 at 15:00 CET 

The presentation will be in English via an audiocast with teleconference.

Conference call dial-in:

  • Sweden: +46 85-055 83 53
  • United Kingdom: +44 3333 009266
  • United States: +1-833-526-8382

Webcast:

Speakers:

  • CEO Peter Forsell
  • CFO Andreas Öhrnberg
  • VP Operations & IR Nicole Pehrsson

For further information, please contact:

Nicole Pehrsson, Investor Relations
Telephone (CH): +41 (0)79 335 09 49

nicole.pehrsson@implantica.com

Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. 

The company's Certified Adviser is FNCA Sweden AB, +46 (0)8 528 00 399, info@fnca.se

The information was sent for publication, through the agency of the contact person set out above, on February 25, 2021 at 08:00 a.m. CET.

About Implantica

Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica’s lead product, RefluxStop™, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energising platform designed to power remote controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit www.implantica.com for further information.

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