#FDA #Liechtenstein #Vaduz #Implantica #RefluxStop™

Implantica's Milestones and Financial Overview

Implantica, a leading medtech company based in Liechtenstein, has published its Year-End Report for 2024, highlighting significant breakthroughs in the development and deployment of RefluxStop™, a product designed to combat gastroesophageal reflux disease (GERD). This report not only covers important FDA milestones but also gives insight into the company's financial performance, showcasing the ongoing expansion and recognition of its pioneering technology.

Significant FDA Milestones

RefluxStop™, which is currently undergoing the Premarket Approval (PMA) process in the U.S., showed remarkable progress in the fourth quarter of 2024. The company successfully submitted the extensive clinical Module 2, which includes a five-year long-term follow-up data from the CE mark pivotal study. This is a critical step in securing FDA approval, as it demonstrates the safety and effectiveness of RefluxStop™ over an extended period.

Moreover, Implantica celebrated reaching a pivotal milestone with the completion of the first 1,000 RefluxStop™ procedures in over 40 leading anti-reflux hospitals across Europe. This growing acceptance of the procedure highlights its efficacy and the demand for innovative solutions in the healthcare sector.

Expansion in Healthcare Systems

The company is also making strides within the UK National Health Service (NHS). Chelsea and Westminster Hospital in London has recently joined the network of centers performing the RefluxStop™ procedure, marking a continued expansion of its services in public hospitals.

Furthermore, Implantica hosted its third Global Annual RefluxStop™ meeting in London, gathering over 110 anti-reflux surgeons and gastrointestinal doctors from Europe, the U.S., and Canada. This is a significant increase compared to last year, emphasizing the growing interest and discussions surrounding this innovative treatment.

Health Economic Study

Another highlight is the collaboration with Professor Lars Lundell from the Karolinska Institute in Sweden. A health economic study was published demonstrating that RefluxStop™ presents a highly cost-effective long-term solution for Sweden's healthcare system. This study provides essential backing not only for the product’s clinical efficacy but also its economic viability within health systems.

Financial Summary of Fourth Quarter

Turning to the financial results, Implantica reported a decrease in net sales by 13% to TEUR 442, compared to the previous year's TEUR 508. This decline is attributed to the expenses related to trial devices. The adjusted gross margin for the fourth quarter stood at a healthy 90%. However, an impairment expense of TEUR 1,669 concerning capitalized research and development and patents affected the EBITDA, which increased to TEUR 7,174, up from TEUR 6,942 from last year.

The company ended the quarter with a loss after tax of TEUR 7,339, showing slight improvement over the previous year's loss of TEUR 8,734. This translates to a basic and diluted loss per Class A share of EUR 0.10, a minor improvement from EUR 0.12 previously. As of the end of the reporting period, Implantica had a robust cash position of MEUR 64.6.

Full Year Financial Performance

For the entire 2024 fiscal year, net sales increased impressively by 38% to TEUR 1,936, up from TEUR 1,408 in 2023, underlining strong market interest and growing adoption of RefluxStop™. However, the operating loss was noted to increase to TEUR 25,466 from the previous loss of TEUR 21,840. This aligns with the company's ongoing investment in R&D and marketing to support further expansion and innovation.

Future Outlook and Teleconference

Looking ahead, Implantica remains committed to collaborating with the FDA as it progresses towards a U.S. launch. Following the end of the reporting period, Module 1 has been accepted by the FDA, and positive feedback was received regarding Module 2. This opens avenues for further discussions as they work diligently to bring RefluxStop™ to the American market as quickly as possible.

Investors and interested parties are invited to join a teleconference scheduled for February 14, 2025, at 15:00 CET, featuring insights from CEO Peter Forsell, CFO Andreas Öhrnberg, and Chief Corporate Affairs Officer Nicole Pehrsson. The details for joining the teleconference are available on Implantica's website.

Conclusion

Implantica is positioning itself at the forefront of innovative medical solutions for GERD with RefluxStop™, demonstrating both clinical and economic viability within leading healthcare systems. The company’s achievements in 2024 underscore its commitment to enhancing patient outcomes through cutting-edge technology.