Implantica SDB

Significant events in the second quarter of 2024

• Module 1 review of Premarket Approval (PMA) application for RefluxStop™ completed by US FDA
  • Findings presented, all of which Implantica considers to be minor
  • Decided to submit response to Module 1 together with Module 2 submission
• NHS Trust University Hospital Southampton started performing the RefluxStop™ procedure
• NICE IPAC evaluation process assessing reimbursement of RefluxStop™ within NHS continues with the submission of our clinical and regulatory dossier. This is the support organisation of the National Health Services (NHS, in charge of the public healthcare in UK) which evaluates new technologies.
• RefluxStop™ advanced education program launched in Spain with more than 15 anti-reflux surgeons and gastroenterologists from seven leading reflux hospitals across Spain participating
• Selected new centers started during period:
  • Herzogin Elisabeth Hospital, Germany
  • Cirugía Laparoscopica Madrid, Spain
  • Hospital Clínico University, Valencia, Spain

Significant events after the end of the period

• 4-year results from our CE-mark study published in Surgical Endoscopy showcasing continued excellent results up until 4-year follow-up
• Investigator-initiated study led by Prof. Schoppmann, AKH Vienna, on 40 ineffective esophageal motility (IEM) patients treated with RefluxStop™ published in Scientific Reports, a Nature journal
  • IEM patients represent approx. 30% of reflux sufferers with no ideal treatment available until now
• Ethics Committee (EC) approval confirmed in August for first-ever randomized clinical trial of its kind comparing RefluxStop™ to Nissen fundoplication
• Independent study by Dr. med. Zehetner (Prof. USC) on his first 40 patients who underwent RefluxStop™ procedure published in prestigious Swiss Medical Weekly
  • Further confirming the excellent results with RefluxStop™ in patients suffering from IEM and large hernia

Financial summary second quarter 2024

• Net sales increased 59% to TEUR 554 (349).
• Adjusted gross margin amounted to 91% (94%).
• Operating loss (EBIT) increased to TEUR 5,869 (4,276).
• Loss after tax amounted to TEUR 6,431 (5,311).
• Basic and diluted loss per Class A share amounted to EUR 0.09 (0.07).
• Cash as at the end of the period amounted to MEUR 74.0.

First six months

• Net sales increased 75% to TEUR 1,150 (656).
• Adjusted gross margin amounted to 91% (94%).
• Operating loss (EBIT) increased to TEUR 12,956 (9,146).
• Loss after tax amounted to TEUR 9,903 (10,069).
• Basic and diluted loss per Class A share amounted to EUR 0.14 (0.14).

Telephone conference

Implantica will hold a teleconference on 21 August 2024 at 15:00 (CEST) 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-q2-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=50049902

For further information, please contact:

Nicole Pehrsson, Chief Corporate Affairs Officer
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, info@fnca.se

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 2024-08-21 08:00 CEST.

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.