Saluda Medical Inc CHESS Depository Interest

Saluda Medical Inc CHESS Depository Interest

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Q4 FY2026 · Earnings Call TranscriptAugust 28, 2026

Barry Regan

Questions are welcome throughout today's presentation, and we will address those at the close of the session coordinated by Sam Wells at NWR. Research analysts can raise their hand via Zoom to ask a live question, while all other attendees are encouraged to submit questions using the Q&A function.

Today, I want to start with a simple question. Why are physicians increasingly switching to Saluda?

Why do we believe that this momentum can continue? The answer starts with our technology, but ultimately, it shows up in our commercial and financial performance.

At Saluda, we believe the spinal cord stimulation industry has lived with two fundamental problems for decades. The first is durability.

Many patients initially respond to therapy, but maintaining outcomes over time has historically been more difficult. When outcomes degrade, physicians spend time reprogramming patients, and eventually, some patients abandon the therapy entirely.

The second is economic. Traditional SCS can require significant ongoing support from field organizations.

That creates substantial non-revenue generating activity and limits the scalability of the commercial model. Our technology is designed to address both of these problems.

We believe our clinical outcomes remain among the strongest in the industry, highlighted by 83% pain relief response at 36 months, and no explants for loss of efficacy in the Evoke clinical trial. At the same time, our closed-loop therapy and Evoke automation significantly reduce the reprogramming burden associated with managing patients.

What makes this story particularly compelling is that those clinical advantages are now increasingly translating into commercial advantages. Revenue growth accelerated throughout fiscal '26.

We have been successfully scaling our US commercial organization, and gross margins continue to expand. Despite that progress, we remain at only 4% penetration of the US physician universe.

Now, as many of I joined Saluda after helping build Dexcom. What attracted me to Saluda was the same type of technology disruption I saw in continuous glucose monitoring.

Our conviction remains that physiological closed-loop therapy has the potential to redefine the standard of care in spinal cord stimulation. Fiscal '26 was a year of accelerating growth, commercial scaling, and portfolio expansion.

Revenue accelerated throughout the year, with US revenue growth exiting fiscal '26 at 45% in the fourth quarter. We substantially expanded our commercial organization while continuing to improve physician productivity.

Importantly, we exceeded every major operating metric included in our IPO prospectus, including revenue, gross margin, adjusted EBITDA, and operating cash usage. We also achieved a major strategic milestone with FDA approval of our CAPP24 paddle lead, opening an entirely new portion of the SCS market that was previously inaccessible to Saluda.

Finally, we launched Evoke globally, and today, the vast majority of patients are programmed utilizing our automation. Taken together, fiscal '26 was a year where we executed across commercial growth, product innovation, and operating performance simultaneously.

Before discussing our technology specifically, it is worth briefly revisiting the market opportunity. Despite being an established therapy with reimbursement, physician awareness, and a decades-long clinical history, spinal cord stimulation remains significantly underpenetrated.

Approximately 1 in 4 American adults suffers from chronic pain, yet only a very small percentage of patients who may benefit from SCS ultimately receive therapy. In our view, that gap exists because historical technologies have not consistently delivered what patients and physicians need.

They want durable outcomes. They want predictability.

They want ease of therapy management. They increasingly want objective data.

We believe technologies that solve those issues have the potential not only to take market share, but also to expand the overall category over time. That is the opportunity that we are pursuing.

This slide illustrates what makes our technology fundamentally different. Traditional SCS systems deliver stimulation, but they do not directly measure the physiologic response occurring in the spinal cord.

Saluda's Evoke system does. With every pulse delivered, our system measures neural activation using ECAP technology and automatically adjusts therapy to maintain a consistent target response.

A useful analogy would be a thermostat. The thermostat works because it measures temperature and continuously adjusts to maintain a set point.

Our system operates in a similar way. By measuring neural activation continuously, we can maintain a personalized therapeutic dose even as patients move, change posture, or go about their daily lives.

This objective physiologic measurement is the foundation for everything else we will discuss today. It is what drives the clinical outcomes, it is what drives lower programming burden, and ultimately, it is what creates the commercial and economic advantages embedded throughout the remainder of this presentation.

One of the clearest examples of that advantage is shown here. Historically, reprogramming has been one of the largest burdens in spinal cord stimulation.

Patients frequently require multiple visits each year to optimize therapy, consuming physician time, patient time, and significant field resources. Our commercial experience continues to demonstrate dramatically lower programming requirements.

After the initial therapy optimization period, commercial patients average less than one programming visit per year. That matters for three reasons: first, it improves the patient experience; second, it reduces burden on physicians and clinic staff; and third, it changes the economics of the business, because every hour a field representative spends performing reprogramming is an hour not spent helping physicians evaluate new patients or growing territory revenue.

This programming advantage becomes an increasingly important commercial advantage as scale grows. That leads to Evoke.

At Aspen and other major conferences over the past year, three recurring themes have emerged: automation, artificial intelligence, and remote patient management. We believe Saluda is uniquely positioned across all three areas.

Evoke automates much of the programming process by leveraging data collected across thousands of patient interactions. The vast majority of new patients are now programmed using Evoke.

Importantly, Evoke reduces dependence on individual technical expertise, simplifies onboarding of new field personnel, and improves consistency across the organization. One physician recently described Evoke by saying, 'Now every rep becomes your best rep,' and we think that that is a very powerful statement, because Evoke is not only improving patient outcomes, it is also accelerating commercial scalability.

As you'll see throughout the rest of today's presentation, many of our future growth opportunities and productivity gains are built upon this automation foundation. With that overview of the technology, I'll now hand the call over to Jim.

Jim Erickson

Thanks, Barry. Turning to our fiscal '26 performance.

Fiscal '26 concluded with our strongest quarter since commercialization. In fiscal '26 Q4, total revenue increased 43%, US revenue increased 45%, US patient implants increased 50%, and international revenue increased 39%.

Importantly, commercial momentum was broad-based. Active implanting physicians increased 22% in the quarter, while total implants increased 50%.

That tells us growth is coming from both physician activation and an increasing utilization rate among existing and new physicians. We also continued making progress in the high-volume ASC channel, and continue to see strong demand internationally, particularly in Europe and Australia.

Overall, we exited FY '26 with accelerating growth and strong momentum entering FY '27. Turning now to our FY '26 financial results and FY '27 guidance.

FY '26 revenue reached $90.2 million, up 28% versus the prior year and approximately 4% ahead of our upgraded guidance. Gross margin improved 230 basis points to 48.9%.

Adjusted EBITDA and operating cash usage both exceeded prospectus expectations. For FY '27, we are guiding revenue to $113 million to $122 million, representing growth of 25% to 35%.

We also expect further gross margin expansion to a range of 50% to 52%. The key takeaway from this slide is that we believe FY '27 will begin to show meaningful operating leverage emerge.

Based on our guidance range, we expect approximately 90% of incremental gross profit dollars generated during the year to flow through to improved adjusted EBITDA. This reflects the combination of revenue growth, continued gross margin expansion, and improving productivity across the commercial organization.

In our view, FY '27 represents an important step toward demonstrating the leverage potential of this business model. It is also worth noting that FY '26 international growth benefited from favorable foreign exchange movements and approximately $1.3 million of cumulative revenue associated with the revenue recognition-related accounting transition in Europe mentioned in past quarterly reports.

While we remain optimistic about our international opportunity, these factors create a more challenging comparison entering FY '27, and as a result, we expect more of the reported FY '27 growth to be driven by continued execution in the US market. With that foundation, I'd like to spend the next few minutes discussing the growth opportunities that underpin our guidance and long-term outlook.

This slide summarizes the four primary growth drivers we believe are available to us. First, continuing expansion into new territories; second, increasing utilization within existing physicians; third, launching new products; and fourth, entering new channels.

What is particularly attractive about our current position is that all four drivers are active simultaneously. We continue expanding territory coverage, existing physicians continue increasing utilization, the CAPP24 paddle lead is just launched, and high-volume ASC adoption is in the early stages of development.

Importantly, these growth opportunities are layered on top of a business that already delivered 28% growth in FY '26 and exited the year growing at 43% in Q4. Turning first to sales force expansion.

FY '26 represented a significant investment year for our commercial organization. We expanded the US sales team from 127 to 161 personnel while also significantly increasing the number of fully trained representatives.

Today, approximately 60% of our field organization is fully trained. Importantly, we are transitioning from a period focused primarily on expansion to a period increasingly focused on productivity.

We will continue adding resources to the commercial organization, but at a slower pace than fiscal 2026. The opportunity now is to leverage the infrastructure we have built and continue driving productivity from a more experienced organization.

At the end of FY '26, we had 311 active US implanting physicians in fiscal Q4. That represents only approximately 4% penetration of the estimated US SCS physician universe.

In other words, more than 95% of the opportunity remains ahead of us. At the same time, physician utilization continues increasing.

The average number of patients implanted per active physician has continued to trend upward. That means growth is being driven by two important factors: more physicians adopting Evoke, and existing and new physicians using Evoke more frequently.

With the addition of the CAPP24 paddle lead, we also expand our offering into approximately 2,100 neurosurgeons and orthopedic surgeons who historically have not been accessible to Saluda. Turning to product innovation.

One of our objectives is to establish Saluda as the innovation leader within spinal cord stimulation. Beyond Evoke, we have multiple product initiatives in development designed to support both growth and profitability.

The CAPP24 paddle lead expands our market reach today. Our next-generation IPG is expected to improve both patient experience and manufacturing economics.

Our next-generation leads target meaningful cost reductions and improved physician usability. Longer term, remote patient management has the potential to create entirely new ways to leverage objective physiologic data.

We do not view innovation as a one-time event; we view it as a continuous process that creates patient, physician, and economic advantages over time. Our CAPP24 paddle lead represents one of the most significant growth opportunities currently available to Saluda.

Historically, all of the growth we have delivered to date has come from the de novo percutaneous portion of the SCS market. Even within that segment, we believe we remain in the early stages of penetrating the higher-volume physician-owned ASC environment, which continues to represent an important growth opportunity for us.

Before we even discuss the CAPP24 paddle lead, it's important to recognize that we see meaningful runway within the market segments we already serve. The approval of CAPP24 expands that opportunity further.

Historically, our business addressed the percutaneous segment of the market. The CAPP24 paddle lead allows us to enter the orthopedic and neurosurgical paddle segment, representing approximately $670 million of annual US revenue opportunity that was previously inaccessible to Saluda.

Importantly, this is not a new therapy platform; it is the same closed-loop technology and clinical differentiation delivered through a paddle lead format preferred by many surgeons. It also allows us to leverage much of the existing commercial infrastructure we have already built.

Looking beyond paddle leads, we also see a longer-term opportunity in the replacement segment of the market. Today, there are many patients implanted with competitive systems who remain dissatisfied with their therapy.

Over time, we believe Saluda has an opportunity to selectively target those patients as physicians become increasingly familiar with the durability and consistency of closed-loop therapy. When we think about long-term growth opportunities ahead, we see all three segments as future opportunities.

Taken together, we believe these opportunities significantly expand the runway available to Saluda over the coming years. Turning now to gross margin.

We improved gross margin to 48.9% during FY '26, and expect further expansion to between 50% and 52% in FY '27. Looking beyond FY '27, we continue to see a clear path toward gross margins in the mid-60% range.

Approximately 70% of our cost of goods sold resides within the IPG and lead systems, so that is where we have focused our engineering efforts. Our next-generation IPG and next-generation percutaneous leads are specifically designed to address the largest cost elements within the system while maintaining the clinical differentiation that drives adoption.

Both projects are well-progressed in their development, and their submission to the FDA will be key milestones for the company. Combined with procurement improvements, supply chain initiatives, and increased scale, we continue to see a clear pathway toward substantial long-term margin expansion.

The final piece of the operating leverage story is shown here. Historically, profitability has been challenging across the SCS industry despite attractive reimbursement and procedure economics.

The reason is not pricing; the reason is substantial ongoing cost of management therapy. Our lower reprogramming burden and Evoke automation fundamentally change that equation.

Reps spend less time servicing patients and more time generating new business. As territories mature, productivity increases and territory economics improve.

We believe over the long term, we can achieve a US sales force at scale in which the cost of the sales reps supporting each territory is reduced significantly from current levels and can support a path to profitability. Even with the recent investments in new salespeople in the US, approximately 30% of US sales territories exiting our FY '26 were already operating below a 40% people cost to revenue ratio.

We believe the success of some of our more tenured salespeople is an indicator of the potential future leverage we have ahead of us as it is already beginning to emerge in the business today. With that, I'll hand things back to Barry to close things out.

Barry Regan

Great. Thanks, Jim.

I'll close with two key observations. First, we believe Saluda is solving the biggest clinical challenge in SCS, and that is maintaining durable outcomes over time.

Second, we believe Saluda is solving one of the industry's most significant economic challenges, the cost and burden of managing therapy. Those advantages are increasingly showing up in our commercial performance.

Growth accelerated throughout fiscal '26, we remain only approximately 4% penetrated into the physician universe, and CAPP24 has expanded our addressable opportunity even further. Our objective is not simply to participate in the SCS market; our objective instead is to redefine what physicians and patients should expect from SCS therapy.

We believe we are still in the very early stages of that journey. In closing, I'd like to say thank you for joining us today and for your continued support of Saluda Medical.

We appreciate your interest, and look forward to updating you on our continued progress throughout fiscal-- And with that, I'll hand the call back to Sam Wells for questions and answers.

Sam Wells

Great. Thanks very much, Barry and Jim.

As a reminder, the audience may ask questions via the Q&A function at the bottom of your Zoom screen, and covering research analysts may raise their hands should they wish to ask a verbal question. We would kindly ask that the covering analysts please limit yourself to no more than two or three questions on today's session, and we'll endeavor to get to all questions asked, in some cases combining questions on the same or similar topic.

We'll kick off with two pre-submitted questions. Firstly, just on revenue growth, you've delivered impressive full-year revenue growth through FY '26, particularly over the past two to three quarters since IPO.

What are the key factors you've focused on to drive growth in FY '26? Could you anticipate further acceleration sequentially?

Barry Regan

Yeah. Thanks, Sam.

I'll take that one. Look, we were very pleased with our revenue performance in fiscal '26, obviously closing at 90.2--$90.2 million US, up 28% year-over-year, and representing a $3.2 million dollar US beat to guidance.

Then over the course of the year, we saw US quarterly growth accelerating, and that's a clear demonstration to us that the execution of our commercial strategy is working. To be fair, that's what we expected, and that's what we laid out in our IPO prospectus.

To your question looking forward to '27, there are four core growth levers. The first one is sales force maturation.

A much larger proportion of our reps will become fully productive over the course of the year. Number two, continued physician adoption and training, and we've seen some really nice growth there over the last few quarters.

The third one is deepening utilization from our existing implanting physicians, and we've seen a nice trend there also. Then finally, as Jim mentioned, the recent FDA approval of the CAPP24 paddle, that opens a new $700 million US neurosurgeon channel that was previously inaccessible to our sales force.

Again, we can leverage our existing sales force with these customers that were previously untouched. We exited the year with a lot of momentum, and we're off to a very solid start in our first two months in fiscal '27.

Sam Wells

Great. Thank you.

Next question on physician adoption versus utilization. How much of the current revenue growth is being driven by new physician adoption versus existing physicians increasing the number and frequency of implants?

Barry Regan

That's a great question. I'd say both levers are active and pretty broadly balanced.

Active implanting physicians were up 22% year-over-year in Q4, clearly new physician adoption remains a meaningful growth contributor for us. Then in terms of physician utilization or in other words, implant frequency from existing physicians, this metric also grew approximately 23% year-over-year in Q4.

The compound effect of both drivers is visible in our patient volumes. US implants in Q4 were up 50% year-over-year.

Another important metric for us is new customer education. We had over 2,000 healthcare professionals attend a Saluda education forum in fiscal '26.

This was up 90%, 9-0%, year-over-year. That top of the funnel build should feed adoption throughout fiscal '27 and beyond.

Really, the new physician adoption, in my opinion, reflects the growing belief that closed-loop therapy provides a significant improvement in long-term durable outcomes for patients, as well as lowering the post-implant burden on pain clinics. Then the increase in utilization with our existing docs, that reflects the growing confidence that physicians have in our closed-loop technology, and the real-world outcomes that they're seeing with their patients.

I'd say it's a balanced contribution from both of those levers, Sam.

Sam Wells

Great. Thanks, Barry.

We'll just move to a few of the analyst questions. Just a reminder, please limit yourself to no more than two questions on today's call.

The first is from Shane Storey at Canaccord. Shane, please unmute your line and go ahead.

Shane Storey

Morning. Can you hear me?

Barry Regan

Yeah.

Jim Erickson

Yep, we've got you, Shane.

Shane Storey

Oh, great. Yeah.

Hi, Jim. Actually my question, I only have one question, and it's for you.

I'm sort of struck by the leverage implied by the guidance, which seems to have reasonably flattish OpEx overall this year. Maybe my question is if you could please just chat through how each of the three different expense lines might move underneath that.

For instance, you're pulling back on R&D a bit to sort of allocate more to sales and marketing, that sort of thing, just if you could help there, please.

Jim Erickson

Really good question, Shane. You're right picking at a point we made here just earlier in the presentation that we believe we've got the nearly 90% of the gross profit dollars that'll be able to drop down to the bottom line.

To your point, that sort of implies a flattish operating expense. It really goes to something we talked about earlier in the calendar year.

We did do a reduction in force back in December that did start to do some adjusting and right-sizing of our non-commercial infrastructure. If you think about the G&A and the R&D lines, we actually think that those will have in absolute dollars some amount of decrease that will help offset the fact that we did just talk about earlier, we will be continuing to invest in the commercial footprint at a much slower rate than in '26, but we will continue to increase there.

There will be some increase in the sales and marketing, but that will be able to be offset a bit by some smaller spending lines in the other two areas. It's not that we're not continuing to invest there, but we did have some heightened amount of spend in the last year or so combined with the impact of some of those reduction in force and adjustments that we've made over the last 12 months.

Shane Storey

Thanks. That's very clear.

Last one for me is it looked like from the gross margin outlook chart that you shared in the deck, that the new IPG and leads aren't really the driver of expansion this year in the gross margin, but perhaps maybe just an update on your expected timing for those approvals.

Jim Erickson

Really again good question, Shane. As we've said in the past and said today, obviously the more than 70% of our cost of goods, or the unit cost that we sell into any given procedure is really the IPG and the leads.

We've got a new IPG and new leads, as we just mentioned, that are coming online. Those will dramatically reduce the unit cost.

We said here earlier in the presentation we expect a commercialization that will be sometime in that calendar year '27 time frame for both of them. They're both well on their way in the product development cycle, and in that kind of verification, validation kind of phase.

There's always variability of exactly what that timeline looks like from an approval perspective. These will both be supplements to our existing PMA, a minimum of 180-day review cycle, but as those familiar in the medtech space, there's always some amount of back and forth with the FDA, and with the FDA's reduced staffing over the last 12 months, we're cautious in our expectations of what that timeline will look like, but we're confident in our ability to put together a good submission and have confidence in the ultimate approval.

The timeline of it is always something that's a bit variable when you're dealing with the interaction with the FDA.

Shane Storey

Great, Jim. That's it for me.

Thank you.

Sam Wells

Great. Thanks, Shane.

Next question comes from Melissa Benson at Barrenjoey. Melissa, please unmute your line and go ahead.

Thanks.

Melissa Benson

Thank you, team, for taking a couple of questions. The first one, it's following on from Shane's question around OpEx.

The outlook for the fully loaded territory costs that you've kind of given there and speaking to kind of 75% this year, just help us understand a little bit of the numbers of how you got that. What is included in that fully loaded territory cost?

Because if we think about kind of the full sales and marketing line, if we kind of split that out and try and back solve, is there say 2/3 of that that's actually territory cost and then a third that's kind of supportive or excluded? Just help us, I guess, think about the math.

Then also, when we look at the graph moving forward, it's kind of 55%, 60% for FY '27. Again, that kind of implies a very flat kind of or a very minor addition of reps.

Just help on the math, please.

Jim Erickson

Look, I'll start with we were intentionally not trying to be super prescriptive in the message in the chart. What we're trying to get at is, when we talk about the cost of a territory, we talk about this internally with the team, we're really talking about the people cost that support the revenue.

The cost of the sales reps and any support reps, their travel costs, benefits, the cost of really managing the day-to-day inside the territory. In addition to that, as you would know, a full sales and marketing line is going to include overall just sales management, the marketing support, all that professional education that we've talked about.

Those are, of course, other parts of our sales and marketing spend. What we're really trying to get at is the way we think about this internally, which is it's a productivity metric at the end of the day.

It's for every dollar of revenue we generate, what's the cost we need from the personnel that support that territory. The reason we look at it this way is this is what other competitors have failed at.

Because of that reprogramming burden, you end up with a large need of people costs simply to support the patients that they're selling to and that they're implanting, but also the patients that have been historically implanted. This is the number we think we can continue to bring down.

We actually will be adding people to the sales force, but because so many of our sales force, call it 60% at the end of FY '26, are fully trained, that means another 40% are finishing their training, getting their quota, and really have very little to no revenue that they're driving yet. Today, we have a large amount of our sales force that is kind of a cost without a revenue dollar yet to it.

A lot of this is just going to be the maturation of the sales force that we've got, that we've put in place, that will be starting to get their quota, start to drive productivity, and that's why we'll start to see some sharp decline is really because of how much of our sales force is so early in their tenure with the company. That's really the message we're trying to get across.

The last point I'll say is on the slide, we did make sure we tried to show the progress we've made thus far, while we have a lot of early sales reps. If you take the cost of the people that fully loaded people cost, there's about a third of our sales team that are already in a territory where they're already below the 40% threshold.

We think we can get the whole field even further, but that's just showing you that there is a chunk of the third of the field that's really progressing to where we want to get, it gives us the confidence that over time, we'll be able to start to move that number down even further.

Melissa Benson

Thank you. That helps kind understand the split in that line.

Second question was just around I know Europe is kind of less of the focus versus the US, but we did see Germany had a very strong kind of uplift this year. Is there anything in particular you kind call out there, the German market is a little bit of a different dynamic sometimes to the rest of Europe, but I guess any color on expectations in Europe?

Jim Erickson

Yeah. The one thing I'll say is, we did call out the about $1.3 million of growth in the European business that was related to some timing differences of how revenue was recognized post an Evoke launch.

It's a little bit more of what I'll call, it's real business that was sold, but the timing of how it was recognized got a bit accelerated. Trying to just indicate that there's some one-time revenue that will be a difficult comp as we enter into FY '27.

Really, most of that sits in the German entity. Frankly, the German entity was a real strong point for the European business.

Our leader there has done a really nice job continuing to build a market there without having to build more resources. It's one of our bright spots, but they also benefited from this accounting change.

It's a bit elevated then from the sort of underlying patient volume, if you will.

Sam Wells

Great. Thank you very much, Melissa.

Next question comes from Thomas Wakim at Bell Potter. Thomas, please unmute your line and go ahead.

Thomas Wakim

Hey. Thank you very much for taking the question.

Just looking at the revenue guidance, 25% to 35%, just wondering, are there any one or two factors in particular that you think might really determine whether you end up towards the top or lower end of that range? I'm thinking about the speed of, say, the paddle lead rollout or sales force training or pricing.

Any guidance or thoughts you could provide on that would be much appreciated. Thank you.

Jim Erickson

I'll take a a stab at that, and and Barry may have some thoughts still as well. I I think you you hit on one or a couple of those.

One for certain, Thomas, I think you hit on is the paddle lead. We've been pretty open and clear about wha- what a what an important opportunity we think that is for the organization.

It's it's the same sales force, but a but a, a a whole slew of of physicians and a part of the market that exists. It's revenue-generating, but we haven't been accessing.

That's a it's a driver, but, it is a process where that is a part of the market that's a little bit more hospital-based than ASC-based. It it does sometimes have a value analysis committee process that can take a little bit longer.

These are the some of the unknowns. We're we're starting limited launch, as we've talked about.

We'll be moving to commercial launch here later this calendar year. The so the the slope of that ramp and the speed of uptake as we enter into that market is one of the big variables that, we think we've got a good line of sight to.

We've built some, I think, positive expectations into our growth, but that, of course, will be one of the variables of where we land in that in that range. Then the other one is really a bit more of what I talked about in that newness of the field team.

In the US specifically, we've got 60% of our At the end of the year, 60% of our US field team is on a quota, fully trained. That means 40% of them are finishing their training here in the first half and coming off quota.

The slope of that curve really, a lot of these reps that we brought on more recently, it will drive that that leverage and the profitability at that territory level that we talked about, but it will also have an impact, I think, on where we land in that range. The business just it brought on a lot of talent.

We're really impressed with the talent. We're impressed with how they've come on board so far.

Of course, that has a little bit of variability when you bring those people to market, and will they will the slope of their curve look the same or better than what we've historically done. Those are the things that we think we've got a good estimate around, but of course, those variations can impact how we ultimately finish.

Barry Regan

Yeah. Just to add to that, Thomas, I think the things that we're not thinking will have a big impact on whether we come at the lower end or the upper end of the range, pricing, you mentioned that, changes to reimbursements, we don't see those as variables.

I think it's down to the quality of our execution. Far, in the three quarters being a public company, we've executed very well.

I think that's a big factor, and then retention. We've talked a lot about our sales force retention, we're very pleased where we are right now, but we've got to continue to be focused on that.

Look, I think that the big variable is the paddle. I've been doing this for a long time, and there's three certainties in life: death, taxes, and the inaccuracy of a new product launch forecast accuracy.

It's just we're doing our best to model it, but it's a huge opportunity for us. I think we're very well prepared for it, but we'll know a lot more as we progress through Q1 and Q2, but that's probably the biggest variability factor for us across '27.

Thomas Wakim

Thanks very much. You've answered to a degree I think my second question, which is around that trained sales force, you mentioned 60% are fully trained with the 40% I guess still going through that training process.

Can you just elaborate a little bit more on the timing of which that 40% are expected to come online?

Jim Erickson

Good question, Thomas. At its core, I'll say, generally speaking, that training process is about a six-month process, and so, by definition, this is going to happen in the first half of the year.

It's more about how many of them that were hired in either our fiscal 20 '26 Q3 versus Q4. It's mostly coming at the beginning of the year.

We will, of course, be hiring new people. You always have some amount of turnover, you'll be backfilling, there'll be some obvious churn in the sales force, as there always is, but the people that are untrained today, the majority of those will be coming off here early in FY '27.

Then it goes right back to Barry's point is, can we keep good retention in that sales team so that we're not having to reset as much of any of the territories we've started to launch. That's why we're feeling good about that being part of our growth engine here as we enter into FY '27.

Sam Wells

Great. Thank you very much, Thomas.

I think with that, that concludes the Q&A session of today's results presentation. Maybe with that, I'll just pass it back to you, Barry and Jim, if you've got any final closing comments.

Barry Regan

Yeah. Just thanks again for everyone for participating and listening and supporting us.

I think with our guidance for fiscal '27, we expect to continue the great momentum that we saw over the last three quarters. As we said, there's a number of growth drivers that will continue to fuel our expansion in both the US and internationally.

We feel very well positioned, especially now with the new paddle product in the hands of our sales reps to take advantage of what we think is still a huge unmet need in the SCS space. Ultimately, as we said at the very beginning, we've got a very strong conviction that we will redefine the standard of care for spinal cord stimulation with our physiologic closed-loop technology.

We look forward to giving updates on our progress throughout the course of the year. Thanks, everyone, and thanks, Sam.

Sam Wells

Great. Thank you very much for joining today's Saluda Medical's FY '26 results webinar.

Enjoy the rest of your day. Thank you, and goodbye.