Imricor Medical Systems (IMR) H2 2024 earnings summary

Executive summary

• Achieved significant regulatory milestones in 2024, including CE Mark approvals in Europe and Saudi Arabia, US FDA modular review progress with no deficiencies, and Saudi FDA approval.

• Performed first MRI-guided ablation procedures in the US at Johns Hopkins and commenced pivotal global trials in France, US, and Switzerland, with new site activations in Europe and the Middle East.

• Entered early stages of global commercialization, expanding into Europe, the Middle East, and the US, with growing sales pipeline and increased sales resources.

• Focused on expanding applications beyond cardiac ablation, including biopsy tools, renal denervation, and integration of AI modules into the Northstar system.

• Operating costs, including R&D, were well contained, down 1% to $17.3m, with a strong cash position of US$15.7m.

Financial highlights

• Total revenue for 2024 was US$959,000, up 56% year-over-year, driven by double-digit growth in both equipment and consumable sales and new site activations.

• Equipment revenue rose 109% to $306,000, and consumable product sales increased 59% to $461,000, with first sales in the Middle East.

• Net loss for the period was $29.7 million, up 31% year-over-year, primarily due to fair value changes in convertible notes and warrants; adjusted net loss was $15.6 million, down 7% from the prior year.

• EBITDA loss narrowed to US$15.2m from US$16.0m year-over-year.

• Cash and cash equivalents increased to US$15.7m at year-end, up from US$832k, after raising $32.9 million in equity and rights offerings.

Outlook and guidance

• Anticipates CE Mark approval for Northstar by mid-2025 and FDA clearance in Q3, enabling first US sales and broader hospital adoption.

• Expects major regulatory milestones and new customer site additions in Europe and the Middle East throughout 2025, with acceleration in the second half as Philips software update enables more site activations.

• Ongoing global pivotal trials (VISABL-VT and VISABL-AFL) and first-in-human MRI-guided VT ablation at Amsterdam UMC are key near-term milestones.

• PFA (pulse field ablation) program advancing, targeting atrial fibrillation market.

• Regulatory submissions and product launches targeted for 2025, including TGA submission for 2nd generation MR Vision ablation catheter.