Implantica publishes Interim Report January – September 2024 (Q3)

RefluxStop™ achieves crucial FDA milestone and leaps forward with strong momentum in both the US and Europe

Significant events in the third quarter of 2024

• First national RefluxStop™ user meetings took place in Italy and Spain with over 40 leading surgeons attending – just 1.5 years after market entry in these countries
• Expansion in the UK NHS public hospital network continues with Chelsea & Westminster Hospital in London joining the RefluxStop™ centers
• 4-year results from our CE-mark study published in Surgical Endoscopy showcasing continued excellent results up until 4-year follow-up
• Two important investigator-initiated studies from leading RefluxStop surgeons published:
  • Prof. Schoppmann, AKH Vienna, on 40 ineffective esophageal motility (IEM) patients treated with RefluxStop™ published in Scientific Reports, a Nature journal
  • Dr. med. Zehetner (Prof. USC) on first 40 patients published in prestigious Swiss Medical Weekly (featuring IEM and large hernia patients)

Significant events after the end of the period

• Submitted extensive Clinical Module 2 of Premarket Approval (PMA) application to U.S. FDA. Most crucial module containing clinical portion including 5-years long-term follow-up of CE mark pivotal study
• RefluxStop™ RCT comparing against Nissen fundoplication achieved Ethics Committee approvals at AKH Vienna, Klinikum Friedrichshafen in Germany and for 2 centers in Bern, Switzerland
• Highly successful 3rd Global Annual RefluxStop™ meeting conducted in London, attended by 110+ anti-reflux surgeons and GIs – almost three times the amount that attended last year – from all over Europe, US and Canada
• RefluxStop™ featured in a powerful panel discussion attended by 100+ surgeons and GIs at the American Foregut Society (AFS) meeting in Denver, moderated by Dr. John Lipham, Chief of Upper GI & General Surgery at Keck School of Medicine of USC
• Incredible enthusiasm for RefluxStop™ among top surgeons at the recent annual American and European Foregut Society meetings, fueled by RefluxStop’s excellent clinical outcomes, both in our pivotal 5-year study and supported by multiple centers around Europe presenting their equally excellent results.

Financial summary third quarter 2024

• Net sales increased 41% to TEUR 344 (244).
• Adjusted gross margin amounted to 97% (94%).
• Operating loss (EBIT) decreased to TEUR 5,336 (5,752).
• Loss after tax amounted to TEUR 6,444 (5,699).
• Basic and diluted loss per Class A share amounted to EUR 0.09 (0.08).
• Cash as at the end of the period amounted to MEUR 69.3.

First nine months

• Net sales increased 66% to TEUR 1,494 (900).
• Adjusted gross margin amounted to 93% (94%).
• Operating loss (EBIT) increased to TEUR 18,292 (14,898).
• Loss after tax amounted to TEUR 16,347 (15,768).
• Basic and diluted loss per Class A share amounted to EUR 0.23 (0.22).

Telephone conference

Implantica will hold a teleconference on 15 November 2024 at 15:00 (CET) with Peter Forsell (CEO), Andreas Öhrnberg (CFO), and Nicole Pehrsson (Chief Corporate Affairs Officer). Please see the dial-in details below to join the conference:

Webcast

If you wish to participate via webcast, please use the following link:

https://ir.financialhearings.com/implantica-q3-report-2024

Dial-in

Dial-in numbers to the teleconference will be received by registering on the link below. After the registration, you will be provided phone numbers and a conference ID to access the conference.

https://conference.financialhearings.com/teleconference/?id=50049903

For further information, please contact:

Nicole Pehrsson, Chief Corporate Affairs Officer
Telephone (CH): +41 (0)79 335 09 49
[email protected]

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

The company's Certified Adviser is FNCA Sweden AB, [email protected]

This information is information that Implantica AG 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 2024-11-15 08:00 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.