Onward Med Nv (ONWRF) Q3 2025 Earnings Call

Investor webinar replay

Replay transcript excerpt

Good morning, good afternoon everyone and welcome to our Onwards webcast following the publication of our results earlier today. As usual, before we get started, please take a moment to read our disclaimer. Today's presentation includes forward-looking statements which should be considered with the appropriate level of caution as outlined on this page. The slides and its recording will be available on our website after the call. Today's speaker includes Dave, our CEO, Sean Chiara, our Chief Commercial Officer, and Amory Fraser, our Senior Finance Director. As usual, we go through a comprehensive update before opening for questions. You may submit your questions verbally or via the Q&A module on the platform. With that, I'll hand over to Dave. Thank you, Seb. So it was an eventful quarter four onward. Since our last update, we exceeded 1.5 million euros in quarterly revenue. We received CE mark and U.S. home use clearance from FDA for the Archaic system, and we raised 50 million euros in new equity capital. So let me just run through these in a bit more detail, and then I'll also go into further detail during the presentation that follows. So most importantly for most of you is commercial traction. So we continue to see acceleration of ArcheX in U.S. clinics. We sold 40 units in Q3, and we exceeded 1.5 million euros in quarterly revenue for the first time. Actually, we hit 1.7 million euros, which is nearly a $2 million run rate. It's $1.96 million at today's exchange rates. ArcheX systems are now available at over 60 U.S. clinics. We also achieved several important regulatory milestones. We received CE mark certification for ARC-EX for use in both clinics and homes. We completed UK MHRA registration for the ARC-EX system, meaning we can now promote the device in the ...