All right. Welcome back, everyone. My name is Brett Fishbin, Senior Med Tech Analyst, and I'm pleased to be joined today by Inspire Medical, who is represented by CEO Tim Herbert, CFO Matt Osberg, and VP of Investor Relations, Ezgi Yagci. I'll start us off, and this will be a 100% Q&A session. If you have questions, you can submit them below the video screen, and time permitting, I'll try and relay to management.
Now before we talk about some of the recent news, just wanted to start off by welcoming Matt to the conference and, you know, was hoping, you know, you could just kick off a little bit by, you know, discussing, you know, the start of your tenure here at Inspire, how the first couple of months have gone so far, and then maybe, like, a couple of your top priorities during this first year and what you hope to bring to the table.
Yeah. Thanks. Thanks, Brett. I'm excited to be with Inspire. Excited to be at the conference today, and thanks very much for hosting us. You know, what drew me to Inspire was being part of a company that has already experienced so much success, but still has the opportunity for so much more. You look at the incredible growth of the company, the continued market opportunity that we have to penetrate the market, and the further growth of that market that I think will come as people learn more about OSA and the potential related health impacts.
To address that, we've got an incredible product, and that product has continued to improve over time with each new generation we've released, and it's really enhanced our ability to treat patients, and we expect to be able to continue to invest in that kind of R&D and improve as we go forward. Financially, we have an opportunity to continue to drive profitable growth while still making strategic investments in our products and capabilities that are gonna support our future. Finally, we've got a great team that's committed to improving patient outcomes and driving shareholder value.
You know, the past few months have flown by, but I've spent a lot of time learning the business and industry, working with our executives to understand what are the key strategic initiatives, and then spending time with my finance team to better understand what our capabilities and processes are today. I'm looking forward to continuing to learn and being able to add more value to the organization in the future.
All right. Super. You know, let's shift a little bit to the most recent earnings call, and we'll ask a couple of questions about some of the reimbursement dynamics. You know, just thinking about 4Q 2025, you guys closed with a pretty strong, you know, end of the year, you know, close to mid-teens revenue growth for the year, and substantial earnings growth as well. You know, maybe specifically to 1Q 2026, I think there are some, you know, reimbursement items that were weighing on the outlook, and you're pointing something closer to flat growth in 1Q just given some of the noise.
Maybe just a little bit of an update on, you know, how you guys felt you ended the year in terms of overall underlying momentum, and then if trends in 1Q are moving, you know, kind of in line with what you expected during the earnings call.
Sure. Well, thanks for having us. It's great to be on with you again and for hosting us on the call today. Let me make a couple of comments and then have Matt kinda jump in as well. Back in our earnings call, we talked that reimbursement will have an impact on two fronts, really in the first quarter, and primarily with the coding issue, but also with the WISeR program. We'll get into the details, obviously, with each, but despite these impacts, we believe the underlying patient demand remains healthy, and we're taking actions to overcome these challenges. What's key to reimbursement has certainly been the primary topic for Inspire and created confusion among the centers and physicians, and many have slowed or delayed procedures as a result. I kinda want to.
I know you got follow-up questions too. Thought maybe we could just kinda walk through a couple of them, kinda set the stage here. We've had active discussions with all the parties from the AMA, CPT, CMS, the MACs, as well as the physician society, with the AAO. All parties are active participants in driving to resolution for the patients, and that's really the good news. Touching base a little bit on the coding front. First off, the long-term solution, a new CPT code application was submitted. It has been through the editing process with AMA CPT. It is on the agenda for the May 1 meeting, and it is in line with another submission from the AMA CPT on line or item 12. We are item 13.
Really what it's about is cleaning up 64568, but really establishing a new code for the Inspire V procedure. Hopefully, it'll be discussed at the May 1 meeting, and if approved, it'll go through the RUC process, and that'll be available for use, ideally January 1st, 2028. In the interim, we need to develop a bridge, and CMS started it out. CMS recently issued C codes that are very specific for the Inspire V procedure and really differentiates from 64582, which is the code for Inspire IV. Just last Friday, as part of the process, they identified the payment associated with it, and it does map to the same level 5 APC as 64582, and that's really good news. The C codes take effect April 1st.
That means they're online, ready to use. They are retroactive to January 1st of 2026. Remember last year, we dealt with this with the Inspire V launch on July 1, same approach. These will be available April 1st for centers to be able to use, and the payment's gonna be consistent with what they already paid. In other words, for hospital, the national average Medicare payment will continue to be $32,000, and for ASCs, continue to be about $27,000. Provides good clarity with the C-code for Inspire V and takes care of the first bucket. The next step is working on the professional and surgeon reimbursement. Now, the direction we've been providing centers to this point is to build the policy, and the policy states, bill 64582 without modification.
That's what we've been instructing centers to do. Centers have been doing so, and they have been receiving payment. Albeit it does cause confusion because if you look at the certified coders and they look at the descriptions of 64582, it doesn't necessarily read across to the Inspire V procedure, and they ask the questions about modifier. It's important that we work with the MACs to say we'd like to see some clarification. As they go around and update the LCDs to incorporate the C-codes, we're asking them to make a statement as well to clarify the surgeons that they should be billing 64582 without a modifier or to provide clarity so people understand the process going forward. This is gonna be our bridge to January 1, 2028.
Last thing I know we'll get into a little bit more is the WISeR program. It's new this year. It's in effect in six states, and it's where the centers must submit to the WISeR program to gain prior authorization for Medicare cases in those six states. Initially, in the beginning of the year, we had a little bit of challenges with the coding aspect, not uncommon with the other Medicare cases in other states. We also had the technical issues with the prior authorization, and we're learning from that, and we're getting greater experience so if a case gets denied, we can understand why to make sure that information is included in other prior authorizations to help streamline this process. It has caused delays and frustration for the centers in those six states, we're working through it.
We're gaining experience to help them kinda understand what the minimum requirements they need in the prior authorizations. As we move forward, we'll use that experience to kinda streamline this a little bit more forward. I'll stop there. Matt, you wanna jump in?
I'd only add, Tim, you know, as you mentioned, you know, clearly these things are impacting our business in the first quarter, and we called some of that out when we talked about it. Look, we're still getting new information up to and including, you know, last week. As the kind of time and manner of how this plays out to get further resolution, you know, we're gonna bake that into our forecasting process as we think about the rest of the year.
I think, yeah, no. I mean, I think all of that makes sense. I just, given there was a lot there and a lot of, like, new news, I do wanna unpack that a little bit more.
Sure.
I think, like, high level it makes sense, and it's also very fair to say that during the quarter there were more changes than originally assumed. I can definitely understand, like, just a little bit of, like, a period where everyone needs to figure it out. Maybe just, like, specifically for the physician fee, you know, like, the facilities you mentioned are back to billing 82 during the first quarter. Just curious, like, if you have any data points or, like, feedback on the potential use of 52 modifier in any cases and, like, if you were able to get any data points around, like, what the change would look like if it was closer to 10% or 50%, kind of like the range that you talked about on the last earnings call.
Yeah. So far this year, we don't have a lot of experience with use of a modifier at all. Really what the focus has been is build a policy and build a 64582, and all MACs have received and we've been paid with that procedure at this point. Again, that causes some confusion with the coders at the centers because it is the descriptor of 64582. Again, we're asking the MACs to as they update the LCDs with the new C-codes, to also provide a little bit of guidance for the surgeons so they understand if it is gonna be 64582 without a modification to sort of stay or if they are gonna be asking for a modifier, if we could get consistency across the United States.
Right now, it's continuing to bill to policy, which is bill 64582 without a modifier.
I also just wanted to ask. I mean, you touched on the C codes, but I think this is the first time that you've had a chance to, like, really talk about that. Maybe just, like, at a high level what your impressions are of this. Call it a temporary measure before you go through the RUC and, you know, try and work towards the dedicated code. Just like your overall thoughts on this more specific C code that matches the procedure versus using 82 in the interim period.
Sure. Well, again, CMS has been very active in the process. They've understand what happened, I mean, last year when we were using 64568 for 10,000 Inspire V procedures, and people were accustomed to using that code. The disruption, of course, with the new tech APC. CMS looked at that. They really understand the issues, and they wanted to find a bridge to be able to get to the new CPT code. Well, the C code is a great tool for them to be able to introduce that. The C code description is really closely aligned with Inspire V. That's why CMS did that. They also want to do is several other C codes as well.
What's important for us is we now have that bridge to be able to carry us forward until the time that a new CPT code is put in place. Again, this is really for facilities, and it's up to the surgeons who will continue to build the CPT codes, in this case 64582. The good news is we expected that, when they come out with the C codes, that they would map to the same level 5 APC with the existing 64582. Not a lot of surprise there, but nice that we have that confirmation in hand right now, and we can kinda lean in and work to get the clarification next on the surgeon payment, and then finally go to work on the new CPT code on May 1.
Yep. No, it makes sense, and definitely yeah, more clarity is good. But maybe just like on that point, like I think I agree with the assessment that like the C-code description makes a lot of sense, and it's good that the facility payment is consistent with 82 . I guess like the one question I had is, it seemed like with the transition to 82` , we were kind of like moving into a more stable backdrop where like customers knew how to bill and like knew what was going on. I'm just wondering if you think that like this additional change is likely to cause like material disruption as everyone kind of like has to figure it out again, like how to bill properly.
Well, I think it's something that we need to make sure centers are aware of and make sure that we communicate that with everybody. The good news is it's pretty consistent just going from 64582 to the C-codes. They know what the reimbursement's going to be, so there's not a lot of surprises there. Maybe switch a little bit to commercial. I'm sure you'll have a question about that. The commercial, believe it or not, is still using 64568 because we built a policy, and that's what's in their policy. Those, again, are prior authorized. For the most part, we're the center. It's just for the Medicare cases to get them to transition to start billing the C-codes after April 1.
My other follow-up on the C codes, like you kind of started to talk about it a little bit, just like the impact on the physician fee coding. If you have any thoughts on like how that plays out. Like presumably once everyone's on the same page, the facilities are billing to the new C code, no change in facility reimbursement mapping to the same APC. Like how does it work or how do you expect it to work with the physician fee coding?
Well, with the MACs will go through and update their LCDs to add the C-codes in there. Our ask with the MACs is to please clarify for the physicians the professional fee reimbursement should be billed with 64582 to get commonality across the U.S. If they wanna introduce a modifier right now, what would the reduction of that modifier be? Again, right now, per the policy is 64582 without a modifier, and that's been accepted and paid so far. We just would like the MACs to really kinda clarify that and be comfortable going forward 'cause this does cause that little bit of confusion with the centers and the coders 'cause the descriptors of the CPT codes don't really read across as well as they should.
That's our second key factor that we'll continue to work on right now.
All right, perfect. My last reimbursement questions, you also kind of started to discuss, and, you know, one of them was about the RUC process, and it sounds like that's still the preferred long-term route is, you know, establishing a Category 1 code that could become effective in 2028. I guess I'll just like ask the last two in two parts if you have any additional thoughts on like that process and potential like outcomes or timing. The other question is on commercial 'cause I was, you know, starting to think if the commercial payers are billing 68, then like does that lead to some level of like pull forward in 4Q? Or is there like an earlier time where the private payers could like realistically reassess their coding before 2027?
Maybe if you have any thoughts on either of those two, and then we can kinda move on.
Sure. Well, let's start with the CPT code application. That was submitted a while back, and we've been through the editing process to make sure that the application is complete. Right now it's out for open comment period. Then, when the comments are collected, they will be discussed at the May 1 AMA CPT panel meeting. As I mentioned before, we're tab 13 right after the AMA has an application to clean up the 64568 code in tab 12. We have the material in place to be able to go and review that.
If approved, it will get turned over to run the RUC process, which is valuing that, and that's when they will survey physicians to make sure they get the proper amount of work identified for the Inspire V procedure and generate the proposed RVUs, relative value units such that when that code, if approved and becomes available on January 1st, 2028, it comes with full reimbursement set. That really is the long-term solution and a code that's gonna be specific for V As we mentioned before, the C codes and the physician coding is really the bridge to get us to that point. From a commercial standpoint, we worked really hard last year to get 64568 incorporated into all the commercial policies.
It is there, and we continue to utilize 64568. Remember, commercial and Medicare Advantage cases are all prior authorized with the commercial payers, and we do submit that CPT code as part of the prior authorization process. Therefore, the centers have an authorization letter to move forward. Once the C-codes are in place, do we expect that the commercial payers will eventually transition over? Probably, that's fine. We'll be able to pivot around that as well and just update and adjust t he prior authorization submissions to the commercial payers. Again, those are all contracted rates, so it won't affect really the reimbursement for the centers or the physicians.
We could stay with 64568, but I think eventually they may go to the C-codes, but they also know that in 2028 they'll switch over to the new CPT code.
All right, perfect. I think that was pretty comprehensive in terms of the reimbursement updates. Maybe just to kind of wrap this all up, just thinking about, like, the guidance and, you know, the flat expectation in 1Q, 4%-10% for the full year. Just kinda wanted to ask the same question that came up on the earnings call, just about kind of like getting comfortable with the range given the level of change that's taking place. Maybe just, like, how you think about visibility through the year.
Yeah, I mean, right now, as we stepped into the guide for the year, there was a lot of moving parts that were taking place. As we've gone through Q1, we're learning a little bit more. We've got, you know, hopefully some more data points that'll come out here in the following weeks. You know, I think the biggest thing we look at is the timing and the manner of kind of what we get more clarity on the open items and coding can really change the outcome of this year. We're watching that, watching our current trends, and then as we get into our forecast process, you know, we'll take a look at the rest of the year. There's things happening to us from the external perspective.
We're doing things internally as well. We have a lot of active programs on how do we continue to convert customers further through our pipeline more efficiently? How do we make sure our marketing dollars are spent really targetedly? We're trying to do some things internally to take action where we can to be as efficient as possible. We're watching, of course, what's happening externally and then bake that all into our next forecast process.
Perfect. Yeah, no, I think all makes sense to me. Let's shift gears a little bit and talk about Inspire V and some of the innovation and data that you guys are bringing to the market. I think we kind of had to touch on some of the reimbursement stuff, but you mentioned that underlying patient activity is healthy, and there's a lot going on with the actual product launch. Let's kinda get into that. Hoping we can maybe just start with, like, an update on where you are in regards to the full, like, full market launch of Inspire V. If you have any updates on, like, what percentage of customers are live on SleepSync and just how, like, the overall, call it, like, latter phase of this launch process is going.
We're fully launched in the United States. The acceptance of Inspire V has been very strong, and that's what's so encouraging for the team and the healthcare providers and watching the performance of V, the comfort that the ENT surgeons have, and in planning the Inspire V, especially not having that pressure-sensing lead, is a significant positive change for this platform. I think from the metrics we used to talk about from surgeons trained to contracts signed to SleepSync programmers, I think over 90% of the centers are all engaged with Inspire V. We have good inventory right now to be able to support the Inspire V implants and the launch is complete and we're moving forward.
I think also, you know, really interesting is over the past couple of quarters, you've, you know, started to publish an increasing amount of clinical data that directly speaks to Inspire V outcomes, even compared to, you know, prior generations of the product. You've had two different studies, and in the original Singapore study, like one of the data points that you've talked about a little bit is, you know, the improved inspiratory overlap. I was wondering if you had, like, any new thoughts on or just, like, updated color from the customers or surgeons on just, like, how the improved sensing and inspiratory overlap is translating to better patient outcomes.
Absolutely. Well, let's kinda talk about a little bit of that data too. We know that the airway collapses during the inspiratory period. The design of the Inspire system is to be able to detect when patients are inhale versus exhale and timing, where it's stimulation of the hypoglossal nerve during the inspiratory cycle of respiration. That is what we define as the inspiratory overlap. I think before we kinda get into that, just wanna look at a couple of key things of the Singapore study that's so important. We use the same parameters as we have over the years. The number one measurement is the Sher criteria. Sher is S-H-E-R. It's doctor that identified the acceptable performance or a responder rate analysis. What we saw in Singapore is a 79.5% responder rate.
Now, that means you have to have at least a 50% reduction in AHI, apnea-hypopnea index, and the resultant AHI had to be less than 20%. 79.5% success in the responder rate. That compares directly to, like, our own STAR trial back in 2012, which reported a 64% responder rate. That's the data for which you're saying competitors compare against. Over the years, we've really kinda changed the patient selection criteria, the implant techniques. Now, of course, going to the fifth generation device. What's key to driving these successful outcomes is the inspiratory overlap. What we've shown with Inspire V using an accelerometer that's now inside the neurostimulator is we're able to get up to 87.1% coverage of a respiratory breath, inspiratory overlap.
Are we providing stim when the patient inhales? That compares to the Inspire IV at 79.4%. A statistically significant improvement even over the Inspire IV device, which was very, very effective. Really excited about that. The second element to it is the surgeons don't implant the pressure-sensing. It is, we all know, putting that lead in the intercostal muscles has always been a little bit of the uncomfortable part of the technique. Not having that has really helped surgeons reduce the operating room time, make it more in their wheelhouse to be able to do the procedure. It has improved reliability because the number one culprit and the reason patients have to have a revision is exactly that pressure-sensing lead. Removing that, it's good for the patients with a little bit of improvements there.
Really excited about V. We no longer manufacture Inspire IV units. In fact, we're converting that line over to a second Inspire V manufacturing line. We have strong inventory to support our activity for the rest of the year.
All right. Great. Yeah, I think it's important that we'll talk about the competitive landscape, but it's important that everyone, you know, compares to the most recent data and most recent product on the market, and not the original STAR trial. Maybe just continuing on the clinical data point, you've started to also release some of the findings, like, from the initial U.S. Inspire V procedures across the 11 centers that, you know, were originally participating. Maybe just unpack, like, some of the key findings that you reported from this cohort of patients. I think, like, most interesting, is around, like, the median AHI outcomes compared to baseline.
Well, I think the first one is in the U.S., we're able to use our SleepSync system, and the patients are engaged with the patient app. We can closely track adherence to therapy, which is really important. If patients don't use therapy, they're not gonna get benefit from it. What we're able to show is patients are using therapy 6.3 hours a night at six months. That's really a tremendous usage. Meaning the people are using the therapy every night, and that really has a significant impact. AHI is improving across centers from on average AHI 30 to below 10 events per hour, which is really, really strong.
Really, the feedback from the surgeons is consistent with Singapore, with reduced OR time, comfort in not having a pressure-sensing lead, and a significant reduction in or improvement in the revision rates, and as well as explant rates, because we track that on an annual basis as well. We're gonna keep trying to push to get a lot of this data to publication, but we've been able to present that at a lot of the physician conferences over the last year.
Yeah. I mean, you also, you know, have talked more about some of the, you know, technical innovation and improvements with Inspire V and a couple of features that you've reported some metrics on, like the smaller step size adjustments, and the ramp and start impulse. You gave some metrics around, like, what percentage of cases are using those new features. I guess, like, my question is, do any of the three that you're reporting on stand out as, you know, most incremental or you're getting the most positive feedback on? Then also, like, to what extent do you think these can be, like, better leveraged as the centers start to kind of get a handle on some of the new improvements versus, you know, prior generations?
These are three examples. We have over 125,000 patients have received Inspire, and we're able to kind of get feedback on what works and what areas we need to improve on. When we talk about things like step size, when patients have their own remote and can turn their own therapy up, well, now we provide a little bit more specificity to it. They can go up in smaller voltage steps. We have the ramp feature has been really important. Instead of the device just turning on, now it can turn on in a more gradual, more comfortable way for patient adherence. Really, it's about improving the patient experience, just across the board.
I think as centers become more advanced in using these, you'll see those are pretty commonly used across the board.
Wanted to ask, you know, software. It's something you've talked about.
Right
In the past, but just thinking about Inspire V as an upgradable system, that's something, you know, really new. I think on the most recent call, you know, you started to talk about some of the R&D activity taking place around software improvements. Maybe just dive in a little more to what, like, some of the incremental features that you expect can be eventually upgraded on the same hardware, and maybe just, like, generally how you think about potential cadence of the software updates for Inspire VI.
Sure
You know, eventually Inspire VII.
Yeah. I think what's really exciting about it is Inspire V is a platform. It's not just a one-time device. Inspire VI is a firmware upgrade to V. What we expect out of VI is sleep detection. When a patient falls asleep, the device will turn itself on at night. When they get up, it'll shut itself off in the morning. That's only firmware changes, and that's just the beginning of this. Eventually, we wanna get into being able to determine if patients are having events and be able and eventually have a device that will auto titrate just like AutoPAP. We're years away. Right now, 2026 is really a development year for Inspire VI and building the algorithms.
Of course, the FDA has a period of time to be able to review that. We're in the development cycle for VI right now, but we already have line of sight for several enhancements to follow right behind that.
You know, I think it's exciting and probably something that can, you know, move to the forefront in future years as you get closer and, you know, some of the other topics hopefully stabilize a little bit. Definitely more to come there. One other thing that, you know, has stood out to me in the presentations, and I don't know if it's been discussed much, is the concept of therapy evolution built in, which is, like, different than just software. I was hoping you could maybe touch on that. I think there was a point about multiple electrodes and new stimulation targets. Any, like, early thoughts on those items would be great.
Well, V again is a platform, and in Inspire V we have multiple output circuits today. We only use one port. Again, kind of bringing GLP back in. GLP- 1s are gonna be effective, but we are doing research on a high BMI device, if you will, which is a dual-channel device that Inspire V is a platform that allows us to do multiple channel stimulation as just one example. We are conducting research on that right now to see if there's a different mechanism that can help pull down the strap muscles, help deal with the lateral walls associated with high BMI. We're active with that development, and we continue to look for other alternative approaches to leverage our strong technology. We'll report back on that in the future.
Yeah, definitely more to come. I think net it's exciting, and you talk about, like, 80% type of responder rates, but there's still so much more to come in terms of, I think, better titration, like more specific detection of sleep, so better adherence, and then the things you're looking at the longer term. We'll follow up on that in future years. The last topic I wanted to ask about is really competition.
This is the first year that you're facing, like, an actual, you know, full year of new competition in the HNS category with Nyxoah. So just wanted to ask, like, kind of what you're seeing in the field, and kind of like what you're thinking in terms of the impact on centers trialing the new device, and just, like, how you think about that in the context of your guidance for the year?
Well, I think we incorporated a small amount in our guide just to certainly recognize that centers will trial new devices. It's their job to make sure they understand what's out there, and the expectations are very high. As we got done talking about, the experience of Inspire V really puts expectations on any kind of new technology. We know people are gonna trial the device. We're okay with that, and we kind of built that in, but we make sure that they really understand that they can count on Inspire V. They know the outcomes they're gonna get, they know the consistency with taking care of their patients, and the support they're gonna get from Inspire. We stay in close contact, we monitor it closely, but again, not too heavy to date.
All right, perfect. Then maybe in our last two minutes here, a question for Matt. Just thinking about profitability, which has improved significantly over the past couple of years, and you're starting to progress to respectable operating margin. Just thoughts about, like, how you balance at a high level revenue growth and all these investments in product improvement with, you know, earnings growth, and maybe just kind of putting into context how big of a priority earnings growth is along with revenue growth. If you guys had any other final thoughts to leave the group with, kind of sign off with that.
Yeah. Thanks, Brett. Yeah, I mean, definitely we're looking to drive profitable growth. You know, the way we've gotten here is continue to make the right investments. You know, we talked about product development and make sure we've got the best product on the market, and then we've done some unique things in the patient journey and getting, you know, DTC, and we're gonna continue to make those investments. We wanna continue to drive growth, but we do wanna continue to improve our profitability, and that's gonna be the balance of what we do here over, you know, the next year and beyond.
Brett, I'll grab a minute just to say we have the best product in a very large, under-penetrated market. Our technology helps patients live better, healthier lives. We're gonna continue to show evidence that how Inspire, when used, is helping people reduce major cardiovascular risks. That was a big data point in 2025. We really wanna kinda lean, you know, lean in on that, and we're gonna work hard. We've got to be able to resolve the challenges with reimbursement WISeR. We know that's our focal point right now, but the good news is we have a pretty strong technology and people to be able to weigh in once we get through the reimbursement challenges. Again, thanks for hosting us again.
Yeah, no, same to you. Thank you so much, all three of you for participating today. Thank you to everyone who's tuning in to listen. Hope everyone's conference goes well for the rest of the day and tomorrow.
Great. Thank you.
Thanks, Brett.