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Implantica (IMP) investor relations material
Implantica Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary31 Oct, 2025
Executive summary
Significant progress toward U.S. FDA approval for RefluxStop, with successful inspections, regulatory milestones, and positive FDA feedback.
RefluxStop addresses a large unmet need in acid reflux treatment, offering superior outcomes and fewer side effects compared to existing solutions.
NICE in the U.K. has approved RefluxStop for NHS public hospitals and severe GERD cases, expanding market potential.
U.S. market launch preparations are underway, including production scaling, new tools, and engagement with key opinion leaders.
RefluxStop generated significant enthusiasm at major U.S. conferences, reinforcing clinical credibility.
Financial highlights
Q3 net sales reached EUR 365,000, up 6% year-over-year; nine-month net sales were EUR 1,543,000, up 3%.
Adjusted gross margin was 93% in Q3 (down from 97%); nine-month margin improved to 94%.
Q3 operating loss was EUR 4.4 million, a 17% year-over-year decrease; nine-month EBIT loss reduced to EUR 13.13 million.
Net loss for Q3 was EUR 4.415 million; nine-month net loss was EUR 12.627 million.
Cash and short-term investments totaled EUR 53.3 million at quarter-end.
Outlook and guidance
Best estimate for U.S. FDA approval is the second half of Q1, with a well-defined path to U.S. market entry.
U.S. hospital contracts expected to take at least three months post-approval before surgeries can begin.
Expansion in the U.K. anticipated following NICE recommendation; regulatory submissions for Japan, Canada, and Brazil planned for 2026.
R&D and new product launches are on hold until after U.S. launch.
Detail the final FDA approval steps
Leverage LINX™ non-US market exit?
How long will current cash last?
FDA rule changes impact on timeline
Nissen RCT pause rationale and restart plan
Funding strategy for pipeline products
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Next Implantica earnings date
Q4 202519 Feb, 2026
Next Implantica earnings date
Q4 202519 Feb, 2026
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Frequently asked questions
Implantica AG with headquarters in Horw/Luzern (Switzerland) is a company developing and distributing innovative solutions for reconstructive surgery. The company’s range of products includes implants based on the unique Zoladex® technology, which is used in a wide variety of applications such as industrial implants, biodegradable drug carriers and scaffolds. In addition Implantica provides best-in-class synthetic meshes for use in hernia repair procedures.
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