Good day, and thank you for standing by. Welcome to the Q1 2025 Business Update and Year-to-Date Highlights webcast and conference call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one-one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one-one again. Alternatively, you may submit your questions via the webcast. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Sébastien Cros, VP of Communications. Please go ahead.
Thank you, Sharon, and welcome everyone to ONWARD's webcast. Earlier today, we shared our results for the first quarter of 2025 and year-to-date highlights via a press release available on our site. The replay of this webcast will also be made available on our investor relations platform after the session. Before we get started, please take a moment to read this page. Today's presentation includes forward-looking statements, which should be considered with the appropriate level of caution, as outlined in the disclaimer. Today, I'm joined by Dave Marver, CEO, and Amori Fraser, Senior Finance Director. Dave and Amori will provide an update on our progress before we open 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.
Thank you, Sharon. Thank you, Seb. Thank you to all of you who are joining us today. As is our tradition, I'd like to start with a company overview for those of you who are new to the story. ONWARD is pioneering therapies to restore movement, function, and independence in people with spinal cord injury and other movement disabilities. We are doing so with three purpose-assigned neuromodulation platforms: ARC-EX, ARC-IM, and ARC-BCI. ARC-EX delivers ARC therapy externally through the skin. ARC-IM delivers ARC therapy via a fully implanted platform. ARC-BCI pairs ARC-IM with an implanted brain-computer interface to restore thought-driven movement. We're here because there are nine million people worldwide living with spinal cord injury. It is a large and expensive unmet need. The TAM is significant at $17 billion, and we're attacking this with innovation.
We have 10 FDA Breakthrough Device Designation Awards and over 150 issued patents, nearly 300 if you include country validations. In terms of stage, we are now commercial. The ARC-EX system is available in the United States. with excellent initial demand and market uptake. Our future is bright. We have a robust pipeline that includes implantable and brain-computer interface technologies, including for Parkinson's disease and for stroke. Some of the highlights for the quarter: very strong early U.S. commercial traction. That's the most important thing. We're really pleased with how the quarter progressed, and we also made significant advancements in our pipeline on the science and technology fronts. Commercially, we met our Q1 objectives for what was a phased or limited initial launch of ARC-EX. We trained and deployed our field organization. We established a sales and service process.
We built a roster of reference clinics, and we sold 10 units, which was precisely our target. Demand indications are also very strong. I'll get into those a bit later. In terms of technology, we announced our fourth and fifth successful BCI implants to restore thought-driven movement. We also announced the first inhuman implant of the ARC-IM Lumbar Lead, which is designed to help restore mobility. On the scientific front, the PATHFINDER II study results were published in the journal Neuromodulation Technology at Neural Interface, showing that sustained access to ARC-EX therapy can continue to drive functional improvements. In fact, participants continue to make gains after one year of treatment. On the financial front, we established a sponsored level one ADR program in the U.S. to facilitate American investor trading. All right, let's dig into the launch, which is, I'm sure, foremost on most of your minds.
Start out with the demand indications. Very strong. We're really pleased. Since FDA authorization in December of 2024, we have received over 3,000 leads globally. These are inbound indications of interest. Over 2,000 in the U.S. alone, 300 of which are from clinics. We are tracking exactly to our planned phased launch. Strong demand, strong early traction, building momentum in the first half for the full year. Starting in Q1, which is what we call phase zero, we wanted to deploy up to 10 units, learn how to start up a clinic, get our sales organization up and running and trained and so forth. Done. We sold 10 units. In the first half, our target is to sell up to 30 units. At this point, our expectation is that we will indeed sell approximately 30 units in the first half, which is almost over.
It's just a couple of weeks to go. Second half of the year, we want to expand the market, expand indications. Indeed, our applications for home use in the U.S. and CE Mark, which will allow us to commercialize in Europe, both are on track. This is really a story of momentum, and we're delighted with the first indications out there. This is an interesting slide. We wanted to share kind of the illustrative or typical clinic dynamics for a center that, in fact, purchases and deploys ARC-EX. What we find is, on average, one device will support 15-20 patients who are coming into the clinic two to three times a week. There's often a waitlist. There are patients in queue waiting for treatment, which is driving demand for potentially a second unit.
Certainly, all of this demand could transition once we have home use into, again, latent interest in buying the device. We are excited about what we are building here with in-clinic use and what that holds for the future. Those of you who follow ONWARD on social media, this is not a surprise to you. There is a lot of enthusiasm and strong positive feedback from all over the U.S. I mean, these are representative posts coming from Michigan and Washington State and Illinois and New York State. The device is being very well received. This is sort of qualitative evidence of what I presented on the previous slide, that there is a lot of interest from patients that are already engaged in the therapy or who are waiting in queue to get access to the therapy. We are continuing to build out our sales organization.
We started out with six, but based on the early demand indicators, we've accelerated an increase in that organization. We should be at 12 by early Q3. That includes, as shown here, one Sales Leader, eight Sales Territories, three Clinical Support Staff, and then we're devoting one headcount just to focus on government and VA opportunities. Moving beyond the launch, we were busy in several other areas of the business as well, continuing our leadership in the BCI realm. There was also an important ARC-EX publication and the start of our U.S. ADR program. Let me run through these in a bit more detail. In January, we announced the first commercial sales of the ARC-EX system. Also in January, we announced that the ARC-EX system was available on U.S. VA and government online procurement platforms. In February, we announced publication of the Pathfinder 2 results.
More details to follow, but this is a one-year study showing the benefits of sustained access to ARC-EX therapy. In March, we announced that we were awarded grants from the Michael J. Fox Foundation and U.S. Department of Defense to advance our work in Parkinson's disease. Also in March, we announced enrollment of the first participant in an early feasibility study to address mobility challenges in Parkinson's disease. Also in March, we announced first in human use of the ARC-IM lumbar lead designed to restore standing, stepping, and lower limb mobility. In April, we announced that we had established a U.S. ADR program, and we began trading in ADRs on the OTCQX Best Market in the U.S. In May, we announced that the fourth and fifth patients were implanted with the ARC-BCI therapy, advancing our leadership position in BCI. More details to follow on those in red.
All right, so first, PATHFINDER 2. This is a one-year study showing the benefits and importance of sustained access to ARC-EX therapy. This is a multi-center clinical trial, 10 participants with chronic spinal cord injury. In aggregate, there were 120 sessions of activity-based therapy combined with ARC-EX therapy. Some key takeaways here: significant functional improvements after one year of ARC-EX therapy. The improvements were observed throughout the one-year treatment period with no plateau. That is important. In our clinical study, Up-LIFT, we only had two months of treatment. Now this study shows what occurs after one year of treatment and indeed continued benefits during that one-year treatment period. Three individuals improved their AIS classification, and one individual switched from a complete to an incomplete injury. Important study coming out of the U.K. We also, as I said before, introduced a U.S.
ADR program, which was intended to enhance U.S. investor access, broaden our shareholder base, and increase stock liquidity. ADRs are designed to make it easier for American investors to purchase, hold, and sell U.S. instruments representing non-U.S. securities. They offer several benefits, including convenience. They trade in U.S. dollars and accessibility. It allows investors to gain exposure to international companies without opening a foreign brokerage account. BNY Mellon sponsored this on our behalf. As stated here, they are pleased to work with Onward Medical on the important step to expand our presence in the U.S. market. We also announced, importantly, continued BCI leadership with our fourth and fifth successful ARC-BCI implants. Two additional BCI implants occurred for two different indications: one for upper limb, one for lower limb movement. We are planning additional implants in the future, including for stroke.
We are working on the technology as well. We are advancing the BCI technology that was exclusively in license last October. Experience so far is good. This is a quote from neurosurgeon Jocelyne Bloch. "We continue to have excellent experience with ONWARD ARC-BCI therapy, which provides the data and resolution we need with a less invasive surgery than is required with other BCI platforms." We benefit from continued media coverage, particularly in the U.S., where we have had some high-profile coverage recently, which creates additional visibility for the company and our technology. Two examples here: 60 Minutes and 60 Minutes Overtime. Pictured here is Anderson Cooper, probably the U.S.'s most high-profile news personality. 60 Minutes is one of the longest-lasting and most highly respected news programs on the air in America. We were also recently named one of Fast Company's world-changing ideas for 2025. This is important.
It's good for recruiting. It's good for investor engagement. We think eventually it's also going to introduce marketing efficiencies because we're growing awareness for the company in important markets. Now I'd like to turn it over to Amori to discuss the Q1 results. Amori, take it away.
Thank you, Dave. We are pleased to report revenue of approximately EUR 400,000 for the quarter. This is primarily driven by initial commercial sales of the 10 ARC-EX units in the United States. We ended the quarter with a solid cash balance of EUR 50.5 million. Our cash burn for Q1 was EUR 9.5 million. This is slightly lower than the previous quarter at the end of 2024. However, as in previous years, we typically see lower spending in quarter one, with activities ramping up over the course of the year.
We remain focused on managing our cash position with discipline and care to support our long-term value creation. Back to you, Dave.
Thank you, Amori. All right, now for the outlook for the rest of the year in terms of milestones. We do, as usual, have robust expected news flow. We have broken this down into each of our three platforms. Starting with ARC-EX in impulse red here. We already have FDA authorization and first commercial sale in the U.S. We expect for the balance of the next 12 months, home use authorization in the U.S., CE Mark, which will allow us to commercialize in Europe, and first commercial sale outside the U.S. In turquoise here is ARC-IM, where we already have first participant enrollment in an early feasibility study for Parkinson's disease mobility. We further expect an interim results publication for the blood pressure indication.
We expect IDE approval from FDA to allow us to begin the Empower BP pivotal study in the U.S., again, addressing blood pressure instability. We expect first participant enrollment in that study. We also expect to use ARC-IM, which is quite a versatile platform, to address urinary incontinence or bladder function after spinal cord injury. We received a grant from the Christopher Reeve Foundation to support that research. In black, you see the BCI track, where we already have announced additional implants for upper limb and lower limb after SCI. Additional implants are expected, but we also expect to start a study using BCI in stroke. That might be news to some of you, large adjacent population using the same technology. A lot of leverage here. These are all kind of activity-based milestones, regulatory and technology milestones.
We also expect to have an outstanding rest of 2025 powered by the level of activity that we see in the field, all the inbound leads, all the product evaluations, all the quote requests. We have a very full late-stage pipeline, and we expect significant acceleration in revenue and system sales through the end of this year. All right, let's start with Q&A here. Sébastien,
wait.
What's that?
Back to Sharon.
Yeah, I think we can take some of the written Q&A, and then maybe we can bring it back to Sharon for some of the others. All right, analysts on the line, get your questions ready. We'll be ready for you in a couple of minutes. All right, this is a question about when we might have approval in Europe, in particular the Netherlands.
As I mentioned in the prepared remarks, we expect to submit our MDR application in the first half of the year. Everything is on track, and we therefore expect to have CE Mark authorization by year-end. That would allow us then to begin commercializing ARC-EX in Europe and indeed in the Netherlands. That is your question, Mark. We have one here from Clément from BNP Paribas. You are considering covering ONWARD. Thank you for your interest. Question about ARC-EX. You see that we are pricing it at $40,000 U.S., but you are wondering how much of that nets to ONWARD. Indeed, we have a direct sales organization. We are not paying a distributor partner in the U.S. All of that revenue comes into ONWARD. In Europe, for most of the countries, we expect to go direct. Some countries, we expect to go indirect.
At this point, again, we are realizing all of the revenue, and that's reflected in the first quarter results, where we sold 10 units and the revenue was EUR 400,000. All right, now let's go to Sharon, and we'll hear from some analysts. If they're not ready, we'll go back to the written questions.
Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. If you wish to ask questions via the webcast, please type it into the box and click submit. We will now go to the first phone question. One moment, please. Your first question comes from the line of Thomas Vranken from KBC Securities. Please go ahead.
Hi, good afternoon.
Thank you for taking my questions and congrats on the strong quarter. Three questions from my side. Maybe first of all, with the 10 devices that have been sold, could you provide some granularity there with the types of clinics that these were sold to? Were these all linked to the VA, or do you see a mix? Also, do you see multiple devices being sold per site, or is it 10 different sites? Thank you.
You basically consensus at one.
Okay, that was your three questions, Thomas?
That was the first one.
Oh, that's just question one. Okay, you're going to get your money for it, aren't you, Thomas? Yeah. We were quite intentional in these first 10 units.
We wanted to place them in kind of a cross-section of clinics so we could learn more about their purchasing process, the ways in which they train, the ways in which we can insert ARC therapy into their care pathways. They are indeed a cross-section. Several of them are based in the community. Some of them are large, kind of well-respected, globally renowned academic clinics. All over the map, so to speak. That is what we wanted out of these first 10. My gosh, I forgot the last part of your question. Yeah, with regards to whether it is multiple devices being sold per site or yeah. Yeah, I would say year-to-date, we do have some instances where clinics have purchased more than one. Driven, for example, by the queue, by the waitlist. Most of our sales are indeed one unit per one clinic.
Okay, that is clear.
Following up on that, from the perspective of these treatment centers, how successful are they in bringing back their long-time spinal cord injury patients, especially for patients where the injury has been years ago? How quickly do they reconnect to these patients, or do you see any bottlenecks there?
It is interesting. Patients that are already undergoing care are certainly opting to try ARC therapy, but we also have a lot of patient-driven demand. They have heard about the device on social media or via conventional media. They are going in. They are asking whether they can try the device in the clinic. If a clinic does not have the device, they are asking them to purchase it and make it available. We are seeing patients really come from all corners, I would say.
Okay, thank you. Maybe as a final question, that is more on the BCI side.
I was wondering, and we're now at implant four and five, with regards to some of the earlier or the first implants that you have done, how would you rate the efficacy or the durability of efficacy there? Is the functionality of those devices still maintained there, or do you see rather a decrease over time as we have seen with some other BCI players in the market?
Yeah, thank you. Very good question. We're not seeing any degradation in signal quality or function. That is indeed a result of the form factor. We are not penetrating the dura. We are not penetrating the brain. This is an epidural system. The brain is not going to fight back or encapsulate electrodes with our system. This is among the chief reasons that we selected it to continue our work with BCI, as it is highly clinically viable and enduring.
Indeed, there is now seven-year, almost eight-year safety data showing that there is no degradation in signal. This is among the reasons that we feel we have a leadership position in BCI. It's the viability and practicality of the BCI itself, as well as ONWARD's expertise in understanding how to stimulate the spinal cord.
Okay, that's very clear. Thank you so much, Dave. Much appreciated.
All right, next Sharon.
Thank you. Your next question comes from the line of David Seynnaeve from Degroof Petercam. Please go ahead.
Hello, David. Hi, good afternoon. Maybe on the stroke efforts, I know you have one patient already implanted with the BCI for upper limb. But yeah, just curious there if you should expect any more update on new implants soon and just in general how the stroke opportunity compares to SCI and Parkinson's disease. Thank you.
Certainly stroke is a large patient population, and there are opportunities to use ARC-IM, ARC-BCI, ARC-EX to address stroke. We're still in the early stages, the learning stages. We are spooling up in collaboration with a large U.S. clinic a study on ARC-EX in the stroke population. We expect to start an ARC-BCI study in Europe on the stroke population. I think it's too early to comment on how effective this is. Again, we are in learning stage here. This is a good opportunity to also reiterate kind of what we've set up here. ONWARD is very focused, using our capital in careful ways to drive the commercial uptake of ARC-EX and then execute the Empower BP study for ARC-IM.
In the meantime, we are advancing the future pipeline with the benefit of grant funding, as is the case with both of these studies that I just described.
Okay, perfect. All right. Maybe just one quick follow-up, if I may. If all goes well, and you scored the home use approval by year-end, right, of ARC-EX, how should we look at this home use? Which rate do you expect this to go gradually throughout 2026, or do you expect a rapid switch there in the fourth quarter already of the patients that have been exposed to the treatment throughout this year?
Yeah, thank you, David. Indeed, we do continue to expect home use clearance as well as CE Mark before year-end. Can't tell you precisely when that's going to be. We can control the part of that that we can control.
We are very actively driving clinic sales here so we can deliver an excellent year. Home use would be a nice accelerant there. I cannot tell you how quickly it is going to happen, but we are filling the pipeline. We are filling the queue because each of these patients who are experiencing ARC-EX therapy in the clinic or on the waitlist, they all then become candidates for home use when indeed we get the clearance. This pool of candidates is just growing each time we sell and start up a clinic with ARC-EX. Thank you, David, very much. Sharon, let's move on to Ed Hall.
Thank you. One moment, please. Ed, your line is open.
Perfect. Thanks, Dave. Congrats on the quarter. A couple of questions on ARC-EX from my side. I think if we look into H2, how can we think about account permeation?
Of course, you've had a controlled release so far. Obviously, given the strong interest that you've seen, how can we see in terms of the accounts you expect to permeate by the end of the year? I guess that would be the first question. In terms of you mentioned a lot of clinics are running backlogs, and you've seen a sort of high number of leads that you shared on that slide. I think that's great. In terms of the visibility, what does that give you in terms of ARC-EX placements for home use? What is the lead time of manufacturing for this? I guess, obviously, is there a percentage that you could take into account that may not continue with this current lead? I'm just trying to get a sense of how viable is the backlog?
What is the lead time in manufacturing this going forward?
Ed, next time you ask a question, I definitely need to write everything down. I'm not sure I'm going to get to everything. I'll repeat it. I didn't write it all down. Let me just address this qualitatively, okay? In terms of account penetration, we haven't given a number. You know what the consensus is. You know what you forecasted for revenue. We're confident we can place enough units by the end of the year to meet consensus based on the activity level, the demand indicators that are out there. We actually track those demand indicators and our funnel very carefully. We track all the way from inbound leads to initial engagement with customers to product evaluation to quote generation and so forth.
Then we attach probabilities at each stage of the funnel. We have, in my view, again, acknowledged that we're fairly early in the launch. We have a pretty good view as to what we can do in the second half, which is why we have confidence that we can meet consensus for the year based on the demand that's out there. In terms of how the queue will impact home use, I don't know yet, right? I mean, we have a lot of patients that are having a really good experience in the clinic. It's not so easy if you have tetraplegia to get to the clinic two or three times a week. I'm confident that's going to translate into demand.
I would say the majority of that's going to be in 2026, pending, of course, when we get home use approval this year.
Perfect. Just a couple of follow-ups. Just quickly on the manufacturing side, obviously the leads are a significant number. What's the turnaround time in manufacturing an ARC-EX device? Could you just remind me? Just a housekeeping point from my end, the EUR 0.4 million in revenue, is that entirely driven by ARC-EX, or is there any grant money in there? That would be my final two. Thanks.
You bet. First, on manufacturing, we have ample inventory on the shelf and ready to ship. I don't anticipate any manufacturing or supply constraints for the balance of this year. In terms of revenue, just one moment. Dixie? Sorry, I couldn't read your writing. Oh, the grant income is de minimis.
Perfect.
Okay, so negligible. Ignore it, effectively. Yeah, yeah, yeah. Perfect. Thanks very much, and congrats.
All right. Thanks, Ed.
Thank you. There are currently no further phone questions.
All right. Let me see here. Let me take some questions here. So Mr. Pepper always asks the question. Thank you. When available for home use, commented on that earlier. Let me just reinforce that the submissions are proceeding in line with our plans for home use and European approval. We continue to expect that we'll have those before year-end. Okay, another one from Mr. Kirsch. So in the upcoming news flow and catalyst, we characterize those as in the next 12 months. Could some of those happen already in this calendar year? Yeah, indeed. The important ones that I just discussed, CE Mark, home use, we expect those to occur this calendar year.
We also expect to commence our pivotal study, what some of you call our phase III, this year in the U.S. and Europe. Okay, what else do we have here? Okay, another question from Thomas from KBC, because three is not enough. Any impact from U.S. import tariffs? At this point, it remains unknown, the impact of tariffs. However, as we discussed on the last call, we do believe we are exempt from import duties due to our category, and we are pursuing clarification on that front. More to come there. This is a question from JP Morgan Stein. Thank you for your question. Who manufactures our devices? We work with very well-respected MedTech CDMOs, so contract design and manufacturing organizations in Europe and the U.S. For ARC-EX, we work with a partner called Demcon in the Netherlands. For ARC-IM, we work with OSYPKA and Integer.
Those are disclosed publicly, so I'm very comfortable sharing those. I think that's about it. Sèb, anything else?
No, I think we've covered everything. Thank you.
All right. Amori, thank you. Thanks, everyone, for joining. We're going to go ahead and post this on our investor website, right?
Absolutely. The replay and the deck will be made available later today on the Investor Relations platform.
As always, we're quite active on social media. If you want to stay updated, please follow us on LinkedIn, ONWARD Empower, O-N-W-D Empower. Thank you very much.
Thank you.
Thank you.
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.