Good morning, everyone, and welcome to today's introductory investor webinar for Saluda Medical Inc. My name is Sam Wells from NWR, and joining me from Saluda today is President and Chief Executive Officer, Barry Regan, as well as Chief Financial Officer, Jim Erickson. Having successfully raised 231 million AUD from new and existing shareholders, the company is set to commence trading on the ASX this morning at 11:00 A.M. Sydney time under the ticker SLD. Given it's the company's first publicly listed investor session, Barry and Jim will spend some time this morning providing a high-level introduction of Saluda, with reference to details included within the ASX announcement and presentation materials released to the ASX this morning. The audience will have an opportunity to submit questions via the Q&A function at the bottom of your screen throughout today's session, and we will endeavor to get to the majority of questions asked, in some cases, combining submitted questions on the same or similar topic, and we'll seek to have this session wrapped up in approximately thirty minutes, including Q&A. Thank you, and over to you, Barry. Great. Thanks, Sam, and thanks everyone for joining us today, and thanks to all the investors who have supported this IPO. It's a tremendously exciting day for our company, for our employees, for the physicians that use our product, and for our patients. So we've been working towards this for quite a while, and again, just super excited that the day has finally come. So happy to share today a quick overview and update on our company. Just to kick things off, a reminder of who we are. We're a commercial-stage med tech company. We're focused on developing treatments for chronic neurological conditions using a novel neuromodulation platform. So you'll hear the word neuromodulation a lot. So what does that mean? Neuromodulation is where you use electricity to treat chronic neurological conditions as an alternative to, for example, pharmaceuticals, such as opioids, in the treatment of pain. The clinical data that we've developed for our technology is unrivaled. The evidence is unrivaled. We've undertaken the only three-year double-blind clinical trial, and that has demonstrated superior, longer-term clinical outcomes for patients with chronic pain. So we believe our technology, combined with our clinical data and a much more efficient commercial model, gives us a very significant competitive advantage. As a reference, one in four American adults suffer from chronic pain, and so we're targeting this existing $23 billion total addressable market that is significantly under-penetrated today at only 6%. So we believe we've got a very long and durable growth runway ahead of us. And the capital that we're raising as part of our IPO will predominantly go to our commercial expansion of our U.S. sales force, and we're essentially doubling our sales force over the next 12 months. So with that intro, we can jump into the slide deck. So starting with our leadership team, I'm CEO of the company. I've been in the industry for over 30 years, and you'll see a common theme across our leadership team. We've got a very experienced team. Jim is our Chief Financial Officer. You'll hear from him in a little bit. Mike Mathias, our Chief Commercial Officer, and Aidan, our Chief Operations Officer. It's not typical that you'd have such a tenured and experienced leadership team for, you know, a company of our size that's just going public, but I think it shows to the excitement and the belief that we have about the technology and what it can do for patients. Equally, on the next slide, when you look at our board of directors, we've got some very well-known names in the med tech industry. A number of ex and current CEOs, including Douglas Godshall, who is the former CEO of Shockwave. Douglas had a very successful exit just last year when he sold that company to J&J for over $13 billion. He's our chairman. Rob, sorry, Bob Palmisano has built and exited a number of med tech companies over the last 30 years. Catherine Livingstone is very well known in Australia. Ex-CEO of Cochlear and ex-chair of the board of the Commonwealth Bank of Australia, so delighted to have Catherine on our board. Both herself and Geoff Brooke will actually be doing and participating in the ceremony today. Apologies for myself and Jim. We would love to be there. We've been in Australia three times in the last three months or so, but we're back in the US, really working really hard on executing all of the things that we committed to our investors as part of the run-up to the IPO. Then we've Quinton Blackford, who just joined the board. He's currently the CEO of iRhythm, a really fast, rapidly growing cardiac monitoring company. I think when you see the leadership team we've got, the board of directors that we have, it speaks to the conviction that all of us have that we've got something really special here at Saluda, and we believe that we are gonna change the standard of care for people with chronic pain going forward. So next slide. So in terms of the company, rich heritage with Australia. The company was founded in Sydney back in 2010. Original founder was the ex-Chief Technology Officer at Cochlear, and while this neuromodulation technology that we've developed, we're focused commercially now in the area of pain, and specifically spinal cord stimulation for the treatment of chronic pain and leg pain. This technology that we've developed can be used anywhere that neuromodulation is used in the body today, and neuromodulation is used in the treatment of Parkinson's, for example, in urology, for chronic incontinence and urology. So we've got ongoing feasibility studies and early clinicals in these areas as well. So, as the company evolves, you know, we expect to see not just a pain franchise, but also this technology being applied in a lot of other areas. We've approximately 450 employees in the company. One third of our workforce is in Sydney, in Macquarie Park there in Sydney. All of our research and development, our therapy development and product development, that's all being done out of Sydney. We've... The technology that's been developed there, we've got a very robust IP portfolio, so we believe a very strong barrier to entry, for anyone wanting to mimic what we've done. And then finally, a couple of stats. This year's forecast of revenue, $82 million. You can see the CAGR has been significant over the last, three, four years, at 116% on average. And, we've got, some very strong backing from some well-known institutional investors listed there on the right-hand side. They've supported us, while we were a private company. They're gonna continue to support us through the IPO, and, we're delighted to have such, such well-known names supporting, Saluda. And then I'm gonna hand it over to Jim for the next slide. Thanks, Barry. Really quickly before Barry gives you an overview of the technology here. Today, we're competing in the spinal cord stimulation space, so this is using electricity delivered into the spinal cord to block the pain signals to the brain. It's this concept's not new. This market's been around for over 25 years, and there's four big players in the space today. If you add up their revenue, it's about $2.7 billion of revenue worldwide. About $2.2 billion of that sits inside the United States. That's where, why our biggest focus has been there. It's the biggest part of the opportunity. However, if you add up the total value of the chronic pain patients in total, it's an addressable market that exceeds $20 billion. So only about 6% penetrated today. We think that has a lot to do with some of the shortcomings of today's traditional fixed-dose approaches to spinal cord stimulation, namely the lack of durability of the outcomes of competitive technologies and the therapy burden that it creates. So Barry's gonna describe that to you, but today we're really focused on taking share. Over the long term, we think there's an opportunity to start to expand this market, penetrate it a bit further, and expand the patient profile that physicians are willing to use this technology. And we lost Barry? Hi, Jim. Yeah, I'll kick this off here. Just a quick overview of the technology itself. So, today this is fixed, traditional fixed-dose spinal cord stimulation. So this is the technology that has built the market that exists today. It is two small cylindrical leads that are placed up into the spinal column next to the spinal cord, and a small implant generator that's implanted just under the skin above the hip. That implant then delivers the energy to the spinal cord. That energy is what blocks that pain, that pain signal to the brain. Hey, sorry- The tradition- Sorry, Jim. I'm sorry, everyone, I lost connectivity there for a moment, but I'm back. Do you want me to take over, Jim? Sure. Great. Yeah, go ahead. Yeah, and, and so, apologies there, guys. I'm not sure how much Jim has covered on this slide already, but the $2.7 billion of revenue that Jim described, that is the current spinal cord stimulation business today. All of the big four companies, Abbott, Medtronic, Boston, Nevro, they all have the same basic system. There's not been a whole lot of innovation for the last 20 years. It consists of that implantable generator that Jim was describing. It's also called a battery that's implanted under the skin just above the hip, and then two percutaneous leads that are implanted either side of the spinal cord. It was discovered over 60 years ago that if you stimulate the sensory nerves around the spinal cord, that you effectively block those pain signals, chronic pain signals from going to the brain. Once the physician has implanted the system, it takes about 30 minutes-45 minutes. They hand the patient back to the sales rep from the manufacturing company. The sales rep then does the programming, and the programming consists of turning up the stimulation until the patient feels paresthesia or pins and needles. That's a side effect that demonstrates that you're getting neural activation. The sales rep will then turn down the stimulation by about 20%, give the patient a remote control, and then the patient goes home. and they'll proceed to press that remote control, turning the stimulation up or down on average 40 times per day. The reason that they have to constantly adjust that stimulation is because every time that the person moves or the patient moves, those leads are moving slightly closer or further away from the spinal cord. And so the patients are constantly getting over-stimulated and under-stimulated. This leads to a lot of frustration, so much so that 20%-30% of patients within 2 years will go back to their physician and say, "You know what? Take out this system. I wanna try something different." So this is how the industry has worked and operated for the last 20 years, and there's about 100,000 patients that will get one of these device implanted this year. This is typical of the system and how it works and what we call fixed dose. Then on the next slide is what Saluda is bringing to the market, and this is the innovation that we're bringing. This is the technology that was developed over 12 years in Sydney. Three key elements to the technology. Number one, for the first time, we can actually measure the nerve's response to stimulation, and during programming, our sales rep can actually see how the patient's nerves are responding as they turn up the stimulation. Second thing is, we're able to calculate for the first time, optimal patient dosing. So for the first time, we've got personalized analgesic dosing. So we will develop a window for each patient that is very precise, very narrow, plus or minus 2 microvolts. And then once that's established, we will then monitor the neural activation ongoing, up to 4 million times a day, and then we will adjust the stimulation also 4 million times a day. So basically real time, so that we're always keeping that patient within their optimal analgesic window. So this is what we call the closed-loop technology approach to spinal cord stimulation. As I said earlier, we've got about 300 patents that protect all the tech that we've developed, and also it's very, very difficult to replicate, even notwithstanding the IP. So we believe we've got a significant first-mover advantage here, and I'll hand it back to Jim to walk through the outcomes that we've seen in clinical studies. Thanks, Barry. That's right. As a part of our U.S. approval, we did run a large pivotal trial with just over a hundred and thirty patients enrolled. This was part of that U.S. FDA approval, where we ran the study double-blinded. In this space, there often is a lot of bias inside the existing clinical data, where patients are sometimes influenced by physicians or salespeople as a part of the outcomes collection. We actually ran this study data double-blinded by using the therapy arm, was our technology with the closed-loop feature that Barry described, turned on. The control arm was our device as well, but simply with the closed-loop feature turned off. This allowed the control arm to be a device, our device, stimulating in a fixed output, essentially mimicking the competition's approach. Ultimately, we also followed these patients out three years. This is critical 'cause a lot of the existing clinical data in this space only goes out to 12 months, and it's that long-term durability that has been a problem in this space over the long term. Ultimately, our outcomes, 83% responder rate, that's a patient that has greater than 50% pain relief. Almost 60% high responder rate, patients with greater than 80% pain relief. And in our trial, out to three years, zero explants due to loss of efficacy in the therapy arm. And we also measured that reprogramming rate, that therapy burden, and it was less than one reprogramming event per patient, per year after 12 months, which really significantly reduces that therapy on the patient, but then also on the sales force. Ultimately, it's been those clinical data that have been the basis of our initial early commercial launch activities. We did have approval outside the U.S., both in Europe and in Australia, ahead of the U.S. launch. Those markets have shown some very nice and solid market penetration in the earlier days. More recently, we've been focused on the U.S. market. This is the $2.2 billion of the existing market, and where it exists. These are June 30 fiscal results. The fiscal 2024 number is the first full year of U.S. commercial launch, where we delivered over $30 million of U.S. revenue, growing to nearly $50 million in the second year, in our forecast period of just over $60 million of U.S. revenue and $82 million in total. We are today in our announcement, reaffirming that same forecasted guidance. We still feel strongly in our ability to execute against our goals and objectives to deliver that $80 million-82 million of revenue here in this fiscal year, based on the activities that we're seeing here today through November. Over the long term, there's really a couple of key growth drivers here. It is that investment in continued expansion of our U.S. commercial sales force. While we today, or at the end of June, had 63 fully trained reps inside the U.S., we are working to expand that significantly over time, and as those fully trained reps grow, that will continue to expand our ability to penetrate the market. If you measure where we were at in June, we believe we're only about 30% covered in terms of the territories in the United States of the existing business, ultimately across what we believe is about 180-190 territories, where we want to be able to get to that full coverage of the US, with the funds that we have today. Because of that, where we're at from a footprint standpoint, if you measure the active physician base we have today at about just about 250 active implanting physicians at the end of June in a three-month period, that really only represents about 3% of the total physician population that does and performs spinal cord stimulation procedures today. So we've got a lot of headroom and a lot of opportunity to further penetrate this market as we continue to expand inside the US and in that sales force. And then lastly, that reprogramming rate and the therapy burden that Barry talked about, and we saw in the positive outcomes in that clinical evidence, we measure this routinely inside the company, and we see very consistent really low reprogramming rates commercially, as well as what we saw in our clinical evidence. And that's given us the confidence in our ability to drive ultimately, over the long term, a sales force with a much higher revenue per rep productivity than what the competition has been able to deliver. In this space, the competition has struggled to get above about $1 million per salesperson level, historically, because of the burden of that consistent and constant reprogramming of past implanted patients. We believe we can get to about 40%-60% above that, with a target over the long term to get to about $1.6 million per salesperson. We believe that'll give us a competitive advantage, but in the field, but also a very clear path to an efficient sales and marketing line and a path to long-term profitability. So in summary, you know, we are a commercial-stage neuromodulation company as Barry mentioned, competing right now in the spinal cord stimulation space that is a very large and established market. We've got established reimbursement in that space that our technology fits inside. Ultimately, we've got a very differentiated technology, we believe, in this space, with the ability to sense and respond in a closed-loop fashion, real time. And it's built on a very solid foundation of clinical data, which is always important in any medical device industry. And with the combination of that, we believe we've got a real opportunity to take share here, and that is why we're so confident in in the need to take these invested dollars, reinvest it back into the business and into the expansion of the U.S. sales team to go continue to expand this therapy more broadly to ultimately not only service more patients, but service the physicians that they serve. So with that, Sam, I think we'll, we're ready to take on a few questions. Great. Thanks, Jim. Thanks, Barry. As a reminder, the audience may submit a question via the Q&A function at the bottom of your screen. We do have some questions here. First, on physician recruitment, given the importance of physicians in the context of commercialization, what do you see as the biggest driver of physician adoption that drives deployment? And additionally, who is Jason Pope? I think there was a comment in the announcement referring to some of his comments, please. Sure. Good question. You know, in spinal cord stimulation, historically, adoption is really, over the near term, been driven by the delivery of service in the field, the sales rep's ability to service their customers and their patients, and then small hardware-type differences. We're really trying to change the mindset of physicians and drive adoption through the value of objective feedback, so the ability to really create a personalized therapy by taking the signals and the feedback we get from listening to the spinal cord. That really allows physicians to think differently about predictability of a responder. It allows them to make therapy decisions based on objective physiologic data, which they haven't had before. We also sell on clinical evidence that ultimately leads to the... What we believe are really improved, better long-term outcomes, and so that is also part of the adoption. But what that means is, you know, we've got the responsibility to educate physicians. They have not had the ability to have objective neurologic feedback from the patient while they're delivering stimulation before. So there's a lot of education for the physician, their support staff, and ultimately for the patients that are involved in the ultimate decision for therapy. So it takes time to deliver the education, but we think that differentiation, that objectivity is really critical to that. And then the second part of the question on Jason Pope. Jason Pope is a physician, a pain specialist physician in California. He's been a thought leader in this space for quite some time, and he's been a great partner to Saluda over time, and has been a real thought leader in terms of generation of a lot of clinical evidence and a lot of research around neuromodulation. He's got a lot of passion for his treatment of pain. You saw in the comments that he made, he's got a lot of excitement for what this technology can bring to the space, but ultimately to his ability to treat patients. I know that's why he's excited about this, is 'cause it's been a bit of a passion of his, as well as others, to help support us in our research and our clinical evidence. But, I know he's got passion around the value that it can create for the patients that he serves. That's great. Thank you. And there's a couple of questions just on sales reps. We've heard you talk about the investment being used to expand the U.S. sales force. Can you help us understand where these sales people come from, and what's your training program in terms of timing and ramp up to full productivity of those sales reps? Yeah, good, good question. You know, our sales force is made up of a bit of a mix, as you would expect. Some of the salespeople come from competitive companies, other spinal cord stimulation device manufacturers. You know, we've been able to successfully recruit what we believe are some really high-quality salespeople, highly skilled, with a long history of execution. That lower reprogramming rate is something that's been a really good competitive advantage for us in terms of that recruiting. It allows people more time to sell more time to do what they love to do, and not as much time having to spend servicing the patients of the revenue that they sold two and three years ago. But we also bring some people from other pain space companies, so people that or companies that deliver other products to customers in the pain space. And because we've also recently launched our Eva automated programming platform, which now we've taught the system to do the initial programming itself and automate much of that upfront step, it's started to help bring down the training program and broaden out our ability to at times take sales reps from just other medical device companies that have the right background, the right attributes, and the desire to make a difference in this space. That training process that you asked about, today, about six months. Historically, it was a bit longer than that. It's a training process that goes through the technology itself, but also our sales process. What are the things that make a difference in the ability to deliver value to physicians and to get them ultimately to want to adopt, based on our differentiation? Really good quality training program that we've continued to bring down and I think bring the quality of the training up. So, that's part of our confidence in bringing sales reps on and our ability to ramp that sales force. Yeah, I think just to add to that, Sam, look, I'm not surprised we're getting a lot of questions around sales reps and sales force, because that's really the key to our success here the next couple of years, is very aggressive commercial expansion. I had the opportunity to speak with the leading recruiter for pain sales reps in the U.S., and today there's well over 2,000 pain sales reps in the U.S., so there's a lot of reps out there. But, he said that Saluda is becoming a very attractive career destination for a pain sales rep. And again, just to reinforce what Jim said, one, because of the quality of life. There's a lot of burnout with this type of profession. It's typical for a pain sales rep to have 50 or more patients on their speed dial, and these patients are their responsibility. Once the implant goes in, it's really on the pain rep, not the physician, to support them, and you've got this 6-8 times a year, the patient's coming back for reprogramming. That all has to be scheduled, time in the clinic, and that's non-revenue generating. So there's the quality of life from all of the phone calls that they're getting, because with fixed dose, you need this constant reprogramming. And then there's the time that it takes away from a sales rep. When they wanna be out there selling and generating revenue, they're actually supporting all this non-revenue generating ongoing maintenance for all of the patients who have these devices, and these devices could be implanted for five years or maybe even ten years, depending on the battery life. So that's why we feel good about our ability to recruit really highly talented sales reps from the pain space, but also from outside the pain space. And then Jim touched on it. Because of that lower therapy burden, we're modeling that our sales reps can generate you know closer to $1.6 million of revenue for the company per year, compared to maybe on average $1 million in the industry. So it also. There's a much greater opportunity for them, you know, from a lucrative point of view in terms of making more revenue and income for themselves. So for those two reasons, we feel very confident about our ability to recruit and continue to build the sales force. Okay, great. Thank you. And just on future product or platform potential, you referenced Evoke as the company's first product. Strategically, how do you balance the commercialization of this product versus targeting adjacent market opportunities in the future? Yeah, it's another good question. We're maniacally focused on growing our pain business at the moment. We believe in Evoke and then Eva, which is the automated programming solution that supports it. We've got the technology to win. We've got superior clinical data, and as I go out into the field and talk to physicians, the feedback I get is, "You don't need any more clinical data. You just need more reps." So I think we've got everything we need to win in the pain space, from a technology and clinical data point of view. And if we execute our plan that's in the prospectus from a top-line point of view and a bottom-line point of view, on OpEx and burn rate and gross margin, yet you know, we would be a very attractive target perhaps for one of the big companies. But in addition, we're gonna be developing applications for our technology in these other areas. I mentioned neurology, and I mentioned urology. So while we don't have plans to commercialize that in the next couple of years, if we execute our commercial plan in pain, and we continue to develop and get these other applications and these other therapies to a point where we've proven the feasibility, and we've got some good clinical data. I think those things combined then just would reflect a very strong enterprise value for Saluda in a number of years, so I think to summarize, maniacal focus on executing in the pain space, but at the same time, we're gonna continue to invest and develop this technology so it can be used in other therapies and other franchises. Got it. Thank you. And just on the, you referenced in the presentation to opioid alternative, given the focus on the opioid crisis by the current U.S. administration, how important is the fact that your product reduces or eliminates opioid usage from either a policy or demand perspective? Yeah, I think, look, it's very important. Outside of business, it is a tremendous problem in the US and around the world. The clinical data and what's been backed up with our commercial data, and it's on the screen here, 55% of patients who use our technology, within a year, within twelve months, they've either significantly reduced opioid use or completely eliminated it. And so that's something that, you know, we're very proud of, and I think it's really resonating with physicians. But in terms of the current administration that you mentioned, it is one of their top priorities, and so, you know, as part of our ongoing marketing of our company and presenting the value proposition to payers and administrators, that's gonna be a key point, and we're gonna leverage that data. So, yeah, it's something that I said we're very proud of, and it means a lot to our employees as well, because it's something that impacts so many people in the U.S. today. Thank you. And then just a follow-up to that, a submitted question here on reimbursement. What reimbursement code is the device used under in the U.S., and do you see room for a new code for your treatment, device intensive status or some other way to improve reimbursement versus competitor? Yeah, well, I can't give you the exact code number. Jim probably knows what it is. But what I will say is that reimbursement has been established and has been in place for decades for spinal cord stimulation. So we're just leveraging existing codes, which have been out there. Now, in terms of, you know, are there new reimbursement codes that we're pursuing? One of the things that we didn't mention today is we're developing a new ecosystem for remote pain management. And I came from a company called Dexcom, where we created this ecosystem for people with diabetes, and essentially, because we're collecting all of this data 4 million times a day, we just need to enable our technology with some Bluetooth devices and develop some apps. And then we'll be able to allow people to monitor real-time on their smartphone or their smartwatches, their neural activation, and see how much time they're spending in range and also identify if there is an issue with their therapy. We can also share that data with their caregivers, so up to 10 people can follow them. And so if you think that, you know, over 80% of the people who will get an implant this year, it's 100,000 people that will get a spinal cord stimulator implant this year, 80% of them are over 65 years old. So as people get older, you know, cognitive ability is diminishing. The feedback today is very subjective. So if you've got an elderly parent you're checking up on every day, you're asking them for subjective feedback. Now, you'll be able to see on your own phone exactly what level of therapy that they're getting, are they within their analgesic window, and if there's a problem with the technology. So all of that, as well as sharing the data back with doctors and physicians who can track all of their patients and sharing that data with payers, so we can demonstrate how much better the outcomes are with our technology. We're confident that we can develop a separate, new reimbursement code for remote pain management, and we're the only company who can do that because of the technology we've developed. We're the only company who can measure it real-time and then share it through the cloud. So that's something that, you know, we believe we can commercialize that the next couple of years. So that's definitely one area in terms of reimbursement that we're looking at. I'm not sure, Jim, if there's anything else on the reimbursement side you want to add? No, I think you hit it. Okay. Great. Thank you. And maybe just one final question. What is the specific IFU, and how does it compare to competitors' indications? Yeah, today, our labeling is for chronic pain of the lower trunk and limbs, and it has a inclusion of failed back surgery. It also includes a reference to diabetic neuropathy. We've got some ongoing plans for how we might address the further expansion of the pain etiologies. Really, all of the pain etiologies are on label for device implantation. But in this market, other competitors have started to expand their labels on the pain types. That really gives them freedom of marketing, specifically to referring physicians or patients and build those marketing programs on those pain types. We've got patients across all those etiologies that get implanted based on the, you know, the physician decision-making and the pain specialist. But we do have some future thoughts and plans around how we might add to our label as others have in this space. Okay, great. Thank you. That's all the time we have for questions today. If there are any follow-ups, please feel free to send them through. Otherwise, maybe with that, I'll just pass it back to you, Barry, for any closing comments. Yeah. Look, thanks, Sam, and thanks for everyone for participating. Hopefully, it comes across that the passion and enthusiasm that both Jim and myself have, in terms of making closed-loop spinal cord stimulation the standard of care, in this field going forward, and I just... You know, for our employees who may be watching this, I just wanna hope they have a fantastic day. We've got over 60 of our employees from the Sydney office, going to the ceremony, as well as, Catherine and Jeff, and so, I just hope they have a great time. It's a big milestone for the company, and, again, thanks to all the investors who've supported so far, and, we hope to keep delivering positive news going forward. So, thanks, Sam, for hosting, and appreciate the time, everyone.