Hello everybody, sorry for the delay here. We had some technical difficulties, but thank you for your patience.

We're ready to get started. We have a few slides that we're going to go through and then we have some questions that came in in advance, and we're also going to take questions online if you want to type those in.

I think Andrew will review those and forward them on to me or we'll divide up who's going to take those. I'm John McCutcheon, President and CEO.

I'm joined by Andrew Shute and Gary Dougherty, who I think everybody should know, and let's get started with the presentation. Let me see if I can advance my slides.

Is that advancing? Everybody can see this?

Gary, Andrew, this looks good? No feedback.

Okay. Hopefully you're seeing the investment highlights slide.

We've shown this before, but we think it's just important to remind everybody about our business thesis. I think this shows that we're actually achieving these metrics or goals here.

We've stated repeatedly that we have no direct competitors, and that we're complementary to existing technologies. Our early market release is supporting this thesis and is in fact validating that.

We have numerous cases now, 71 procedures that are complementary to the offerings of Medtronic, Boston Scientific, and Abbott. That is very reassuring and confirmatory.

Also, our TAM is very large and we're validating the TAM build-up. We won't share that slide again today, but you probably've all seen this before where we have the pie chart that shows the TAM build-up that gets to $5.8 billion US.

We're seeing that the cases that we're doing largely reflect the same distribution as in our TAM. Again, further validation of the clinical need and the market availability for the product.

As you all know, we do have FDA approval. The premium reimbursement is now again being further validated.

We knew that we were approved by CMS last year in the fourth quarter, but now hospitals are starting to bill and get their payments back and seeing that in fact they have a good margin, and so that's gaining steam. The premium reimbursement in the past was something that we were confident in, but we can now validate with the payments that hospitals are actually getting.

We've talked about our commercial strategy and we'll have a slide here on our manufacturing scale-up. In fact that's skipped ahead.

The milestones, we like to show this because 2025 really teed us up for our commercial success. So, 2025 we got FDA approval and then really the major milestones were.

Okay. I'm sorry.

Is anybody online, guys? Help me out here.

I see a I see you and me. Andrew's back.

Andrew, we can't hear you. Are there people online?

Are there audience members? There's 50

Yeah, there's 52 people online.

They can hear and see what we're doing.

Yep, and there's questions already coming in.

Okay. Our apologies, folks, for the technical difficulties here.

Again, going through the 2025 milestone achievements, those were things that we had prospectively projected we would hit, and we did, and those are now paying dividends and further leading to our commercial success and again validating the whole business premise that we've started out with when we've first introduced the technology and the investment thesis to all of you. We're currently moving into our new facility, this is a reality.

Gary and I and a few other folks are now positioned in the new facility. We're slowly bringing over some of the technical folks.

The pictures here on the right are images of the clean room and some new equipment that we have in the new space. It's really exciting to see because again I'm not sure how obvious or apparent this is from what we've said, but our current facility has capacity for the next probably year, year and a half, but the major reason we wanted to move earlier of course is to stay ahead of the capacity, but also to bring on new capabilities, and some of these machines that you see here are part of that.

These machines will help us automate and make our processes more reproducible, ultimately leading to better yields and lower cost of goods and faster throughput. It's really exciting to see this equipment come in.

Now we'll be qualifying the equipment, and then we have to validate the clean room, and we hope it's hard to know exactly, but we believe we'll be completely transitioned to the new facility by the end of this calendar year. There's some variability in there.

We'll have to have an FDA inspection that will likely happen towards the end of the third quarter, and then if all goes well, we'll be able to transition over completely. We have some leeway if that doesn't happen on that timeline.

It's not catastrophic, it's certainly recoverable, but our goal is to have everything transitioned by the end of this year. Andrew, if your audio's working, I'm going to let you speak to this slide if you don't mind.

Thanks. We were quite excited to receive the TGA's Priority Review designation.

Australia will be the second market that we'll enter after the US. I think it's great validation of the fact that it's recognition there's a large unmet clinical need, and we have genuinely, truly innovative device to be able to treat that.

I guess this runs in parallel to the FDA's Breakthrough Device designation. Australia is an interesting market apart from being listed here.

Similar to the US, it has a high concentration of high-volume sites, and there's a pathway to get US-equivalent ASPs.

Thanks, Andrew. I think again it's just one more kind of validation point of our clinical need that we've been talking about, but again validated by the government authorities, the agencies, and then also our customers as we continue to do our limited market release.

Andrew, I'm going to also have you maybe speak to the HRS. Both Andrew and I were at the meeting, but Andrew, you bring it up more enthusiastically than I do and I like the way you present it, I'm going to have you do this.

I've been at EBR for nearly 11 years, this is my 10th attendance at HRS as part of EBR, and I'd say without a doubt, one of the most exciting for us. We had five key presentations here: Prash Sanders from Royal Adelaide presenting.

He actually was asked a question at the end by one of the audience members essentially, "Prash, why are you bothering with WiSE when we have conduction system available now?" His sort of mic-drop response was the fact that if you're going to attempt to pace the conduction system, which is on the left side, WiSE is perfectly suited to that.

We also had presentations from Al-Bustami, Paul Gould from the PA presenting on our totally leadless CRT study. Niraj Varma from the Cleveland Clinic presented on our real-world clinical outcomes, the highlight of which was a 50% reduction in our complication rate that we'd seen in the SOLVE study.

Our lunchtime symposium, we had over 450 delegates attend that. What makes that particularly impressive, we had 20 conflicting presentations on at the same time, including six of the lunchtime symposiums sponsored by Medtronic, Abbott, and Boston.

It was

really the quality of the conversations that we had with physicians that was here. Instead of people coming to our booth saying, "Hey, I'm aware of some leadless ultrasound CRT," this time we had physicians coming with a real clear message how they wanted to use our device, how it would fit into their hospitals.

Andrew, if I could just jump in and reinforce a few points. I walked into that lunchtime symposium room.

It doesn't look really big in this picture, it's hard to see, but it looked quite large to me. I walked in when it was before it started, it was empty, and my first reaction was, "Oh gosh, this looks like too large of a room, and if you don't fill a room, it doesn't look like a success."

Even if you had 200 people in a 400 room, it doesn't look very exciting, and you cannot see it in this picture, but there was standing room only. Behind the camera here, there are people standing up watching this, it was really exciting to see that.

Then of course, the content was really good. Then the other thing that again kind of double down on what Andrew was saying is I had a number of physicians come up to me and some were physicians that are already doing cases, current customers, and my question was always, "What's the indication?

Which patients are you treating?" They would get really animated, excited, and tell me about the patients that they're treating that don't have other options or where WiSE is the best option.

I had the same question of physicians that just went through training and are lining up patients, but haven't treated them yet, but they're in that funnel, and very similarly they'd say, "Well, I've got this patient and this patient, and this is the perfect indication." These conversations again further kind of validate our total available market build-up.

We're going to segue to the financials, or maybe I'll just review the KPIs. I think people have seen these before, and again if you haven't heard this talk, the way I like to frame this is that these charts are in order of our selling process.

If you're not familiar with medical device technology and how we roll these out, it's very different from biotech. First, we have to have physician engagement.

In our case, that's the electrophysiologist or the EP, and the EP either they approach us or we have an existing relationship with them. We're not out mass marketing.

These are one-on-one meetings, one-on-one, very personal interactions. If the physician has the right profile, meaning they're at a high-volume center, they're a KOL, they do the similar cases where they do a lot of leadless pacemakers or they do lead extractions on conventional CRT systems, there's a certain profile that we believe and have shown to have confidence in that are going to be really good early adopters.

We make that relationship. They have to commit to a day of training.

We don't pay them for their time, they have to typically fly somewhere. We'll pay their expenses, but we don't reimburse them for their time off, and it could be a working day or a weekend, but they have to commit to this one-day training.

Then the other obligation is they have to commit to helping us with the hospital administrators. The second step is physician engagement and then getting the hospital site negotiated and contracted.

These are the leading indicators, and you can see they're both growing very nicely. Then the lagging indicator, but what's most important to all of us, are the cases completed, which is also revenue, and you can see the growth there.

That growth will continue on cases completed even if we didn't do any more physicians trained or sites contracted. Those are again the leading indicator for future case growth.

We're very bullish and optimistic about our early launch, and everything is going as we hoped and believed would happen. Now I'll turn it over to Gary to go through the Q1 financials.

Gary? Gary, are you on mute?

Andrew, did Gary drop off?

I think he's accidentally disconnected instead of coming off mute.

Okay. I'll start this, but I'm going to look for Gary to back me up here.

On the top row are things that we pre-released, you can see our implant growth quarter-over-quarter. Of course, that directly links to the revenue growth, and you can see we hit almost $2.4 million USD in revenue in the first quarter, very significant growth.

Remember, the first quarter last year was zero, year-over-year growth is infinite. The gross profit and percentage is going to bounce around a bit, please don't fixate on this number.

As Gary's explained before, we're still working through inventory that we had expensed previously, this offsets some of our gross margin, and so you'll see that go up and go down. In the next year, I think in 2027, end of '26 going into '27, you'll start to see it normalize and then hit some nadir and then start to grow like you would expect of a medtech growth company as we get more and more scale.

Our operating expense for Q1 was a little bit higher. We've been adding sales people, manufacturing capabilities, and so that's something that we've forecasted and expected, nothing surprising here from our perspective.

Then another way to look at it is by category. Again, nothing here was out of line from our perspective.

We had some one-time payments that were periodic in Q1, our bonuses payoff. We had some demo units that we expensed into sales and marketing, for training, and then there's a one-time leasehold improvement that'll actually be reversed.

When we've talked about our manufacturing facility before, we talked about the favorable economics, and we had a $4 million expense from the landlord. The way that works though is that we pay the contractors first and then the landlord reimburses us.

There was $2.5 million that went out the door in the first quarter, but we're recovering that in the second quarter from the landlord, so that'll be a wash in the next quarter. You won't see that recurring.

In fact, it'll be favorable in the next quarter. As always, we look forward to quarter-over-quarter revenue growth.

We think that's really the important thing about a company at our stage. You want to see sequential growth, traction, again proving the thesis or the investment thesis.

We'll continue to get more engagement and an education of the hospital administrators. They're all actually seeing that more and more.

We announced the HCA contract yesterday and that was well received by the market, and I think that's an indicator of how the NTAP and TPT adoption works. If I can go a little bit deeper into the HCA process, we have an anchor site, St.

David's in Austin, that's an HCA hospital. We didn't start going after the HCA system.

We started with one hospital. This hospital early on did seven cases, I believe, six or seven, I think it was seven, and then they paused and they let the hospital bill those cases and then see what their margins were and in the economics with our case with the NTAP and TPT payments and so on.

We're not privy to that data, but we can conclude that it was favorable because from there that site helped us get into the HCA general large-standing hospital network. Now that doesn't mean we automatically turn on all these centers, because it's still a physician first, but it means that a large for-profit hospital system like HCA, which is probably the largest in the US, sees us as economically favorable to the point that they're saying, "Hey, we'll let all of our sites start it if they're so motivated."

Now it becomes more of our sales people engaging with individual physicians. Again, don't expect us to en masse start up all of the HCA hospitals, but it means that we don't have to renegotiate all the selling agreement when we go and turn on these additional sites.

We continue to hire and train sales people. When we look at our internal revenue models, it's highly sensitive to sales heads.

In fact, that's the most predictive part. If we do a Monte Carlo analysis and look at all the variables that go in, it's really sales heads that drive expansion and growth.

We'll continue to invest there and I think you should expect to see continued quarter-over-quarter growth in the business. I'm going to pause there and maybe stop sharing my screen.

Hope I didn't log out. Then am I sharing that screen?

I don't want to share that. Okay.

Then, Andrew, I know we've got questions and I might just pre-answer some that came in earlier and then you can text me if there are additional questions. Some of the questions they're in the similar bucket.

It's like, what's going on with cash? There's I guess a belief that we're spending too much relative to where we are in the business.

I just want to rebut that if I could, or I will try and try to convince you of the benefit of investing the way we are. When we look at medtech companies that have been successful, similar profiles as us where they're stand-alone companies, stand-alone meaning they've got one product and maybe in cardiovascular or similar types of companies, they always spend more than they bring in in revenue in the early part of their launch.

The ones that don't aren't successful. What we're managing for, for you, for our investors, and for the success of the company, it's yes, we focus on cash and we have to manage that, but really we're focused on growing the company and scaling.

Because at scale, we get better margins and then eventually that flows down to EBITDA and the bottom line, but early on you're not going to see that. If we scale back on spending now, that's to the detriment of the business and there's no clawing out of that.

We can't save our way to make this a successful business. This is the time to invest.

Again, if you look at any peer that's done this before, that's the model that they follow. If conversely you look at those that don't invest early, they don't succeed.

Ultimately what we're managing for, we want the stock to be strong, we want it to grow, but it's really that terminal value. What is the ultimate exit, the ultimate price that investors and maybe an acquirer will pay in the future for EBR?

It'll be substantial if we continue to make the investments. We're focused on cash, and the other thing, we believe we've been pretty open and we don't get explicit, but we're as open and direct as we can be given our public nature and our disclosure obligations, but we indicated that we had cash that would not take us beyond this year.

That was always in the mix. You can assume that the board and management team are looking at shoring the balance sheet and making sure that we have cash going forward to be successful.

We don't get there by cutting spending, because that cuts our future. We're really focused on the long term more than we are on the near term.

I hope that resonates with folks. It may not, but that's the most honest and direct way to express to all of you how we look at the business and how we're conducting what we're doing.

Andrew, are there any questions that are not related to the burn or how we're managing cash?

Yes, I've sent some to you on WhatsApp.

Okay. Let me Sorry, folks.

Let me pull over there. Okay.

Oh, the maximum capacity of the new facility. The new facility could on two shifts should get us to more than about 9,600 procedures a year, which is about $550 million in rev- US it's all USD revenue.

That's only at two shifts, and you can go to a third shift and a fourth shift even if necessary. That gets us plenty of runway and and and so this is a a long-term facility.

Clearly, if we were going to exceed that, which would be a really nice problem to have, we'd have enough time in advance to start planning the next facility and and upscaling. But $550 million in revenue would be an incredible success and and so we can only hope that that we're butting up against that.

Monthly case support with our existing sales team. We're not there yet.

I don't know how to answer that because the sales team's evolving. Let me speak to that.

We bring the sales team on in waves. This again this is not new to EBR.

This is classic single technology, single device, new technology rollout. You hire sales teams in waves.

We're not a Medtronic or an Abbott where we've got this existing 200-person sales force. We have to grow in there.

There's an investment before there's any return, and then we want to get some some of that return started, but we're going to continue to add in waves. It'll be a progression.

We've we hired eight territories, 16 people last year. We started another four territories or eight people this year.

We plan to start another four territories or eight individuals mid this year, and we plan to kind of do that and continue to scale. The early wave that we brought on, it takes longer to train them and we get more and more efficient in training.

There's a there's a flywheel effect here. Imagine when we bring people on initially, we bring a big bolus in.

To train them, there's a lot of didactic and there's a lot of lab training and a lot of simulator training, but ultimately to train them they need to do cases. At the very beginning, there's very few cases, and you can't have 16 people in a room training on one case.

It's not possible. You're There's a little bit of a chicken and egg where you need to get more cases going in order to really s- train the sales people.

Again, it's a flywheel. We'll We're going to get traction, and and this is not a surprise to us.

This is all part of the plan. It'll get more and more efficient, but it's very dynamic.

It's not static. It's not like there's one number that says, "Okay, they come on here and then it's efficient and it goes."

It's dynamic and we're seeing that progression, and we're starting to see faster training of new sign-ons because they have more cases to see than they in the early days. You'll see some again I'll I'll keep calling it a flywheel or a multiplier effect as we go forward.

It's not a static a static question or a event. How many Let me Let me go back up.

Let's see. How many of the HCA hospitals will you open this year?

I don't know the answer, but we if if you go to the report, there's 190 hospitals in the US. That's not important.

That just means it's a big network. We're still constrained by our sales people.

Again going back to those KPIs, it's more important we start with the physician, then the hospital, then you get cases. Now what it means is our our sales people can then triage an HCA site in their in their territory, and if that HCA site meets all of our criteria our early criteria on physician engagement, volume, the right profile, then they have one less hurdle to go in there.

They don't have to go, "Oh, it's an HCA hospital, I've got to fight this big bureaucracy." What it does is it gives them the ability to go in there, and they may have another site that's more important than a local HCA hospital, it's going to really vary.

I think what I'd rather do is tell you as we sign them on or in retrospect how many we signed, but I don't think I can project with any any accuracy and and give you a number there that would be, really credible. Some of these are things we just haven't gotten There's a lot of detailed questions and we don't want to be in a point where we're where we're giving a lot of forward-looking projections.

It it's a It's a bad habit to get into early on, and I think you'd all be better served if we continue to give you the macro look as we achieve these. I hope you see the confidence that we're projecting in the business, the underlying business, that it's hitting all of our models, everything that we've expect, things that in our experience we've seen in the past that are successful versus those that aren't.

We're also meeting the analysts' projections, and so we're very confident in that. I think for now we're going to keep it at this top line, and I know there's a hunger to get in a lot more detail, but it's not very productive because some of these detailed questions are still in flux.

What we're what we're able to project is more of this macro picture with great confidence. As we get more scale and we get more experience, we can get perhaps more forward-looking projections and more detail, but I think for now it's best for for you and for us if we don't go into any greater detail there.

Andrew, I kind of skimmed through the When does the Oh, limited market release ends. It's not a hard end.

It's a it's a progression, and I think when we say we've now see how we've got enough sales people through where we know we can predict the next class and how fast they'll come on board, because each class now has gotten faster and faster. At some point we'll go, "Okay, now we really know what the how the onboarding process is.

We really know their efficiency. We really know what their yeah, how how fast they become productive and what that productivity is."

Then we'll declare the limited market release is over. We're leaving it open-ended for now.

I don't So I won't prospectively call it, but when we're there we'll say, "You know, we think now we've got all the metrics, we feel like it's reproducible, and we're ready to declare we're now just in this more forward-leaning open-ended commercialization mode." Okay.

Let's wrap it up. If I didn't address your question or if you have other ones, please email them to us and we'll we'll find a way to to get you answers.

You might find some of them non-responses, because sometimes we can't answer the questions directly, but we do want to be forthcoming and transparent. To the extent that we can, we're not trying to hide anything.

We just want to be respectful of of the of the business and our disclosure obligations and make sure that what we disclose is productive and serves the business and our investors in the long run. That's our goal.

We really do want to build a successful business that will return have great returns for the investors, and that's our focus. It's distressing to see the short-term stock price, but really what our focus is is long-term value and long-term growth for all of you and for the business, and ultimately to serve the patients and customers.

That's all congruent as we look in the future. Andrew, Gary, unless there's anything else, I think we should probably wrap it up at this point.

We're over time. So

Agreed. Thanks for everyone's participation.

Thanks very much. Thanks.

Bye everybody.