Onward Med Nv

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 United Kingdom. We received US FDA investigational device exemption, or IDE, for the ARC-IM system so that we can start the EmpowerBP clinical study. We received ULmark certification, which is an electronic safety certification for the Archaic system. And we received FDA 510K clearance for home use in the U.S., which greatly expands our market opportunity. We continued our science and technology leadership, announcing simultaneous publications in nature and nature medicine. And there was another publication on the LIFT home study results in neurology clinical practice. From a company perspective, we raised over 50 million euros in new equity capital, anchored again by Autobach and also anchored by Invis and ASR, and we strengthened our leadership team with the appointment of new senior executives. Let's start with more information on our commercial traction. So you've seen this slide before. This is a demand indicator. We continue to observe very high inbound global interest, about And these numbers are unsolicited inbound requests for more information or for a product evaluation. So thus far, more than 5,000 global leads have been collected, more than 3,300 collected in the U.S. alone, and 430 of them are collected from U.S. clinics. So nearly every U.S. clinic whom we consider a target has reached out to Onward to learn more about this device. Unsurprisingly, our sales are also increasing, reflecting that demand. You know, in the first half, it was a limited launch where we sold precisely the number of units we intended. And then we pre-announced our Q3 results that we had sold 40 units in Q3, placing our year-to-date units sold at 70 and our penetration into over 60 U.S. clinics. We expect the demand in Q4 to remain strong, to be sustained. And there are two important catalysts that may provide upside in Q4, but will largely be drivers for significant growth in 2026. That being the CE mark approval that allows us to market device in Europe, and then the 510k that we recently received for home use in the US. And I'd now like to turn things over to Sean Chara, our new chief commercial officer, to walk through a couple of slides on our commercialization.

Thank you, Dave. We're obviously pretty excited about the two big catalysts that we have in front of us to put us in a great position for accelerated growth in 26. The first of those, as you mentioned, is the European launch. So, as everybody knows, we received our CE mark in September, and since then, we've gone on to complete the additional regulatory work to secure clearance and registration in both Switzerland and, as Dave mentioned, the United Kingdom. Our launch is underway. Our initial focus, as you see here on the slide, will be on the critical cluster of DACH, so Germany, Switzerland, and Austria. To that, in this initial launch phase, we will add the Netherlands and the United Kingdom, so two countries where we've had longstanding partnerships and in clinical trial activity. As we look to expand across Europe, we're going to do that with a combination of direct sales, where we think that's most critical, as well as through distributor relationships, where we think that is most appropriate. We have our leadership in place today. We have additional hiring underway. We commenced selling activity immediately upon the CE mark clearance, and we look forward to first sales here in Q4 and launching some of these early European centers in the fourth quarter. The second of the big growth catalysts is on the next slide. I would say certainly equally, if not more important, and that is our recent home use clearance in the United States, which is all of a week old at this point. Initial response from the field has been fantastic. Our inbound leads are up threefold over our typical levels, and our clinic partners are telling us they have clients actively reaching out to them to talk to them about how to obtain a home use unit. Being able to extend this therapy into the home is obviously a very big deal for the community. For people with limited mobility, being able to extend the therapy into the home makes it more accessible. And we know from the lift home trial that sustained engagement and use of the therapy is important not just for maintaining benefits, but potentially extending benefits as well. The home use trial builds on the tremendous success we've had in the clinic. As Dave mentioned, we've got a footprint of over 60 clinics. As people with spinal cord injury will need to get exposure to the therapy in the clinic to integrate it into their rehab programs, to establish the appropriate stimulation parameters that are optimized to them, all of that is done in the clinic. So having this really large base already in place gives us a really solid foundation in the United States to begin the extension of the therapy into the home. As it relates to our readiness and getting moving, we've established home use pricing for veterans that are receiving their care through the United States Veterans Affairs System. We have the product on the federal supply schedule, so it is available today. For other home users, we have cash pay and third-party financing options. But we also know that ultimately we'll need payer support here to make this therapy as broadly available as everybody in the community and we would like. So, to help both patients and our clinic partners with that, we're going to be implementing patient access programs to support everything from prior authorizations to claim submissions to, if needed, appeals for claim denials. Development of those programs is currently underway. And we look forward to putting them in place in the first half of 2026. On the logistical flows on how a person goes about getting a system, you can see that on the slide. Onward is going to partner with clinics to provide all of that setup and support. So as Archie X is only available by prescription only, it means that the start of the journey for a person that wants to get access to Archie X in the home is the start of the journey is for them to visit their clinic to assess whether or not the therapy is right for them to obtain a prescription. Once there is a prescription that prescription sent to Onward Onward works with its accredited third party partner to complete the prescription verification and billing. And upon payment, the device is shipped directly to the person's home. The person then will take that device to their clinic for setup, for programming, and for training. That training will be both for them and for any caregivers that they have that support them. And then ongoing support after that point is done in two ways. The primary piece of support will be done by the clinic itself, and Onward has a team of therapy consultants and clinical managers distributed around the United States to help support the clinics in caring for their clients. Beyond that, we'll also have support through the Onward Customer Experience team, helping with things like logistics and troubleshooting. And we'll have a bunch of training resources, whether video prints and all of those types of things, on the website to help with the most common questions and the challenges, potential challenges in any of those early stages of use. So we're obviously very excited about these new growth catalysts. We've been working on readiness for many months. We're looking forward to being able to bring the new therapy to people living with SCI in Europe, and then also bringing this therapy into the home, allowing people living with SCI to extend the benefits that they're seeing with RDX in the clinic into the home setting. Enthusiasm is very high for the product.