Implantica publishes Interim Report Q3, January – September 2021
A BIG STEP FORWARD WITH FDA IN U.S.
Significant events in the third quarter of 2021
- Implantica incorporated wholly owned subsidiary in the US, Implantica Inc.
- Implantica filed a supplement to the pre-submission for RefluxStop™ with the FDA.
- Implantica appointed new Chief Commercial Officer with proven track record in global sales of medical products. The commercial team has been strengthened with several highly experienced sales and marketing professionals. Implantica also strengthened its management team with a new VP Quality & Regulatory Affairs professional with over 20 years’ experience.
- Implantica performed the unanimously decided downstream merger with its holding company, Implantica MediSwiss AG, and a split of the class B-shares, not affecting the capital of the listed shareholders.
- Implantica performed the unanimously decided contribution of assets of EUR 117 million from the main shareholder (to the reserves).
- One of the largest and most prominent anti-reflux centers in Germany, Klinikum Friedrichshafen, actively performs RefluxStop™ surgeries after commencing in July.
Significant events after the end of the period
- The FDA has indicated that they would agree to receive a PMA marketing application for RefluxStop™ based solely on existing European clinical data. If approved, this would allow for U.S. market entry without a premarket U.S. clinical trial. As agreed with FDA, Implantica will provide the FDA with additional longer-term safety and efficacy data from its ongoing European clinical investigation at 4.5-year follow-up.
- Surgeons from several hospitals received training on the RefluxStop™ procedure, including four of the UK’s most influential anti-reflux surgeons, as well as several German hospitals. These Key Opinion Leaders (KOLs) are now in the process of screening patients and obtaining hospital approval to start operating with RefluxStop™.
- Implantica appointed new highly experienced Chief Market Access & Strategy Officer having spent over 15 years in market access, reimbursement, health economics and payer relations.
- Implantica bolsters team with a significant additional 14 new hires joining over the next several months. Recruitment has taken place in commercial, R&D, regulatory affairs and clinical affairs
Third quarter financial summary
- Net sales increased 207% to TEUR 83 (27).
- Adjusted gross margin amounted to 96% (96%).
- Operating loss (EBIT) decreased to TEUR 3,904 (4,790).
- Loss after tax amounted to TEUR 4,266 (4,730).
- Basic and diluted loss per Class A share amounted to EUR 0.06 (0.11).
- Cash and short-term investments as at the end of the period amounted to MEUR 135.5.
First nine months financial summary
- Net sales increased 122% to TEUR 280 (126).
- Adjusted gross margin amounted to 94% (98%).
- Operating loss (EBIT) increased to TEUR 9,151 (7,291).
- Loss after tax amounted to TEUR 9,107 (7,127).
- Basic and diluted loss per Class A share amounted to EUR 0.14 (0.16).
Implantica will hold a telephone conference on November 24 at 15:00 CET
The presentation will be in English via an audiocast with teleconference:
Conference call dial-in:
- Sweden: +46 851 999 383
- United Kingdom: +443 333 009 030
- United States: +1-646-722-4902
- 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
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, firstname.lastname@example.org
The information was sent for publication, through the agency of the contact person set out above, on November 24, 2021 at 08:00 a.m. CET.
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.