Implantica (IMP) investor relations material

Executive summary

• RefluxStop® is a breakthrough device for acid reflux, with over 1,500 procedures performed in 50 European hospitals and strong five-year clinical data showing high efficacy and safety.

• FDA approval is in the final stages, with all pre-approval inspections completed and a U.S. launch targeted for 2026; launch preparations and production ramp-up to 10,000 units are advanced.

• NICE endorsement in the U.K. and recent tender wins in Italy and Spain are driving gradual European market access, though reimbursement remains a bottleneck.

• The withdrawal of LINX, a major competitor, from Europe is expected to benefit RefluxStop®'s uptake, but full impact depends on reimbursement progress.

• RefluxStop® is recommended for NHS use in the UK for IEM reflux sufferers, marking a significant milestone for adoption.

Financial highlights

• Q4 2025 net sales reached €530,000, up 20% year-over-year; full-year net sales grew 7% to €2.07 million.

• Adjusted gross margin improved to 92% in Q4 and 93% for the year.

• Q4 operating loss (EBIT) was €7.39 million, up 3% year-over-year, mainly due to R&D impairment; full-year operating loss narrowed to €20.52 million.

• Year-end cash and short-term investments totaled €48.9 million, with no interest-bearing debt and an equity ratio of 96%.

• Operating cash outflow for the year was €16.56 million, improved from €22.76 million prior year, reflecting disciplined cost management.

Outlook and guidance

• FDA approval is expected in the near term, with a U.S. launch targeting 25-50 centers and a focus on rapid market penetration.

• U.S. pricing is targeted at a premium (€8,800 per device), with plans to maintain high gross margins.

• Production ramped up with 10,000 devices ready for initial U.S. launch and registry study.

• European growth will remain gradual, dependent on reimbursement expansion; tender wins and code approvals are paving the way for broader adoption.

• Expansion into Japan and Canada is planned post-U.S. approval, leveraging regulatory acceptance of FDA data.