Inspire Medical Systems, Inc. (INSP) Earnings Call Transcript & Summary

All right. Welcome back, everyone. Rich Newitter here. Inspire Medical is our next fireside chat. We have Inspire CEO, Tim Herbert; and CFO, Rick Buchholz. Welcome both of you.

Thank you very much. It's great to be here.

Sorry, and also Yagci, IR. So for the other fireside sessions, if anyone has a question, there's 2 microphones, feel free to come up and ask a question directly. There's also a QR code on the presentation screen. And if you scan that in, you can send me your question, and I should be able to see it up here. So we'd love to keep this interactive to the extent you want it to be.

Tim, been starting all the panels off with kind of some higher-level thoughts. You guys came off your 1Q, you grew a very impressive 28% in your U.S. business, a healthy growth rate. I would love to just hear any raise your guidance for the year as well. But we about to hear your characterization of how you thought the quarter was relative to your expectations heading in? And how you see the rest of the year playing out? Anything the puts and the takes that you would call out with kind of 4 months under the belt?

Absolutely. Thanks, and thanks for having us here, and it's great to be in Boston with the Celtics winning and keeping you up on light because of the -- how are these going down the street and the sirens, but until an exciting time to be here. Q1 showed a lot of positives for us. We're very happy about that. Number one, we always focus on patient outcomes, and that's the key thing we continue to measure. And that's a key thing that's going to keep the growth of Inspire go on for years to come is the confidence people have when they receive Inspire therapy that they're going to have the best opportunity to have a positive response. Patient demand remains extremely strong for Inspire. And we do everything we can to improve our technologies and improve the number of health care providers that patients can see to be reviewed for receiving Inspire therapy. And so the demand just continues to remain so strong. We know we have seasonality come out of the fourth quarter because we had just a really, really strong fourth quarter as far as implants go. And we knew that people are going to take a little bit of time in January to recover a little bit and then start ramping up as we get to the second -- 2/3 of the quarter, and that's exactly what we saw. So a little bit of a soft start in January but came back with momentum in February and March, which was tremendous to give us the strong growth that you identified there. But that also gives us the confidence going forward. And with that, we were able to increase our revenue guide for the rest of the year, showing confidence in the demand that we have and our ability to have patients see health care providers and be able to get their surgery scheduled and have the benefits of Inspire therapy. So I think that's really kind of important going forward. Further to that, we're able to reach a revenue point with the gross margin that we enjoy to announce that we're going to be profitable for the full year for the first time. And we think that's a tremendous opportunity. We did not want to change our business to become profitable. We wanted to make sure we hit a revenue level with our gross margin to become profitable. We still have very high teens investment in our R&D because our pipeline is so strong. And we still have our investments in our D2C, or direct-to-consumer, because that's a key element to building the awareness in both the brand and helping patients come into the process. And again, with the revenue guide, we see increased growth in our revenue going forward. That gives us confidence to announce profitability for the year.

Great. Good overview there. A lot to follow up on. But maybe just on the U.S. utilization in the first quarter. It declined year-over-year, but I know that there were -- here are some factors you need to normalize for consumer [indiscernible] seasonality. So I think it was -- if you normalize the idiosyncratic items, maybe it was flattish. Is that fair?

I think it was flat from the prior year based on the inventory shipments in Q1 of '23. So we consider it flat at about 1.7% for the quarter.

Okay. So a little bit of growth.

Yes.

Yes. All right. Sorry, 1.7% per account per month. Okay. And then I guess, is there any reason why utilization for the rest of the year shouldn't -- or in 2Q first, but for the rest of the year as well, it shouldn't increase sequentially and then year-over-year?

Yes. When I think if we look at Q1 with having that utilization of 1.7%, and it's kind of where we thought that would come in, we knew that a lot of the sites that do the most implants were very, very busy in December and doing implants on Saturdays at the end of the year. And they're the ones that really are going to take the time in January to refresh before they get back to the momentum in February and March, that inherently kind of drives that utilization. But we see the momentum going forward. So we see continued growth in that utilization throughout the year. And I know we mentioned to people that that's a metric we want to start to get away from now that we brought in profitability, but we're going to provide that data for the rest of the year. So people can measure how our utilization growth is going to go throughout the year. And I think that's really what we kind of focus on is the utilization at the high implanting centers.

Okay. But just to be clear, it's like there's no reason why that wouldn't grow on a year-over-year basis for the next several quarters.

That's exactly what we're working about.

Got it. Right. And then you mentioned specifically on the high utilization centers. And I'm asking this question too in parallel with the decision to take the utilization disclosure, right, by the way you had been reporting in U.S. utilization off the table in 2025. What are the components of the utilization, whether it's the cohorts that are the different types of customers, same-store sales, and I'm sure there's different types of same-store sales and new accounts. Help us think through kind of where the utilization growth is truly coming from? Where it's maybe slowing, where it's accelerating? And then how that factors into why you're removing that utilization figure in 2025?

Well, I think we have about 4 basic sites that we tend to walk through. And the first site is the early adopters. Those tend to be the academic centers. And if we go to all the 50 states and you look at the academic centers, we pretty much have most of those doing Inspire procedures. They're the early adopters, right? Those are a necessary element because they provide the ability to work through the reimbursement challenges that we have, the early days of prior authorization, and they continue to grow. It's a core part of our business. But those physicians have other responsibilities. They have to do research. They have to do clinical studies. They have to try new technologies. And so inherently, they're limited on the amount of time that they can spend on Inspire. They become more efficient, the more cases they go and it continues to grow and that's a key part of it. But where we are today is Inspire is now really community-based health care. And as we all see our family doctors in the community hospitals or community centers, that's where Inspire is growing the most. And so our focus is continuing on that community-based care to be able to grow the utilization there, and we're seeing the utilization in those sites run at a higher rate. And then finally...

A higher rate relative to the other buckets?

To the academics.

Okay. And what about relative to itself on a...

Well, they're going to continue to grow too.

So there's runway, there's plenty of capacity there.

Absolutely. The patient demand remains there as they become more efficient, they can do more cases and what you see more in the community systems is they have systems there, they have the ENT that focus on the surgery, you have the sleep physicians that focus on the longitudinal management. And we can build efficiencies with the ENT where we can use APP, Advanced Practice Provider, who can do a lot of the office space work and a lot of the communication with the patient, not educating them on Inspire, so we can have the ENT really focused their time in the operating room doing procedures because that's where they maximize their own revenue for their practice to pay their staff and to keep the lights on. And so we really kind of focus the -- a lot of our attention on the community based. And one last thing. There's another group that the surgeons also have backup centers. They'll have a secondary set of service that we don't expect significant utilization there because we drive the utilization at the core community hospitals. But the secondary states always are available to -- for overflow or if they have a couple of patients that they want to do, but we don't really expect high utilization at those centers. You put that all together, you get the composite score that you're talking about. It's not really how we drive our business. That's why we look at that. Is that really a necessary metric? And so when we get into '25, we'll be talking about other information that we can provide to investors to have confidence that you can see the strength of the organization and strength of the therapy adoption going forward. And we'll continue to work with everybody to figure out what that information will be provided when we get into 2025.

Can you give us even a teaser of what those potential metrics might be?

Well, it's pretty early to be able to do that. I think we looked at what we provided in the past and even in our discussions, we've given some additional information that really help people build their models and help people really gauge the success of the therapy adoption. But we'll keep working through that as we get through the year.

And just to be clear, right, because some investors have asked, right? Are they taking away the monthly utilization number, even if it's for high-level positive reasons, are they taking away because that number is going to -- or about to move into a decline? I guess...

Yes. But just to hit that tennis ball fall back over the net, we're going to give that number for the rest of the year. So people are going to be able to gauge that through the year and they can compare that back historically. And no, we're doing this from a positive reason and trying to provide information for how we drive the business and how we manage it.

But they're talking about '25. So...

No, I understand. I understand. But I think that we're going to provide the information for the rest of '24, and they'll be able to see that growth all the way through '24. And why would they have a thought that that's really going to change forward. So...

Okay. So it's not necessarily because you see something that, that is on the horizon that could lead to a decline. You're just -- you're maturing, your business is maturing and the types of accounts that are driving the utilization don't match up necessarily to this holistic utilization calculation, and that's not the metric that people should be looking at...

Right. And I think I want to be a little careful on the word maturing. I think we are a growth company. We are investing in our growth. We know our demand is there. We know we're just single-digit penetrated in our target market, and we have miles to go and kind of drive where we're going with our product pipeline and our heavy investments in R&D and all the strength that's coming in the near future.

Got it. And the next question I'm going to ask is just a little bit more your philosophy and approach to guidance, whether or not that's changed at all? And in the context of the level of visibility that you have and how much -- or what the time frame of visibility is? Are you generally able to see kind of backlog orders out 6 months, 9 months for the full year so that gives you a level of confidence in whatever full year outlook you provide? Can you give us a sense -- because you don't give quarterly guidance. So can you give us a sense of what kind of visibility you have, whether it's through your prior authorization...

Well, we internally have the ability to see patients from front end to through implant. And for years after implant because we want to track outcomes, which is again the most important. But we know what we see coming into the top of the funnel. We know how many patients go to our website, spend some time there, take the quiz to see if they are a good candidate for Inspire. We see how many people come to advisor care program and the time it takes us to get their first appointment. And we're improving that technology. We have over 200 centers now allowing us to do escheduling. So we can directly schedule cases right into the [ anti-office ] to get those patients appointment in a short period of time. And as they come off, the sleep endoscopy, which we'll talk about predictor and how we can remove sleep endoscopy for a number of patients, we see how many prior authorizations that were taken care of because those after the third quarter last year, we brought those all back in-house. So we get to see the prior authorizations and the time to approval remains just 2 to 5 days. And that percentage approval remains very, very strong.

And what percent go through...

We're like -- what percent go through Inspire? Tough to [ narrate ] that prior authorization, we probably do with a great majority of them at least probably 3 quarters, other commercial cases we do and we're able to get those approval, and then we can track how long it takes to get those cases scheduled and the time to schedule those cases. So we have visibility of our organization. We have confidence on when we set our guide for the year and what we can achieve. In fact, when we work backwards, we set our direct-to-consumer spend based on those targets going forward. So yes, we're able to see a lot of the data to really be able to manage it. And as we continue to develop our Sleep Sync system, which is the patient management or cloud-based patient management system, that even gives us more data and more accuracy to kind of track the growth and the success of the organization.

Tim, some of the higher volume accounts that are continuing to ramp where capacity is not necessarily a limitation. Where are they right now in terms of number of procedures, whether it's per month or per year? Like what are some of the higher-volume community-based private practices trending at right now?

Well, I think if you look at some of the top centers, those that the ENT spends their time doing surgery and they have great partnership with sleep on the sleep physicians who do the system management and the longitudinal patient management, they have great throughput. And they will have 1, 2, if not 3 surgeons being able to do procedures and those centers can do 15, 18 procedures a month. right? I think the record is 24 procedures in a month. The message there is it shows our ability to grow the capacity at the community-based centers. And even at that level, they could take it to another level up. And the plan is you will see those centers continue to grow. But we want to continue the centers that have opened up in the last 1 to 2 years. They are still growing into their shoes and getting their system moving and working through the patient flow. And that's a lot of where we focus our energy right now is making sure that they understand the best patient flow, and they track the success of the outcomes of those patients, and they track the reimbursement of what they're getting paid because it is both a profitable procedure for the hospital as it is for the surgeon if they have the system operating properly.

So you've got, I think 4 -- I think of it as 4 main buckets for driving capacity expansion or increased capacity utilization in your installed base or through your installed base, you have Inspire 5, which is probably going to come in late '24 or 2025, that's going to be faster throughput, shorter procedure time, that's like mechanical, if you will. You've got the predictor study, which will help over time, maybe eliminating the requirement of dyes in the percentage of your population. I think you've seen -- it could reduce 2/3 of dyes use in your volume mix. And then you have those other items that maybe are closer at hand that you were saying more doctors per account, you're getting changing practice management, working with defining division of labor with sleep physicians and ENTs opening up their time to do stuff. So You have a lot of efforts there. But the timing of when they hit, it feels like those latter 2, you're working on now, but it seems like that's a slog, takes time for that to work. And then the things that we all can see that like our immediate throughput increases, those feel a little bit further 25%, 26%. So is there enough that you can affect with the more physicians per account, the things that you're doing right now to drive enough capacity expansion to continue the growth curve?

That's exactly what we've been doing, right? We've been growing for how many years now, right? And we continue to grow going forward. And it's all about addressing the patient demand that we have. We know the patients come to the top of the funnel and we can sit down with the physicians, and we can show them, these are the patients that you have at your practice that need therapy, and we need to address that. And so we either need another OR day from those surgeons or we need to train their partners. We certainly don't want to take the patients across the street to their competitor, but if that's what it's going to do to make sure that we take care of those patients, we have to do that. But just by sitting down with the physicians -- and so they understand their backlog. And the more cases these physicians do, the more efficient they are with the procedures. And the centers that do the highest level of utilization have the best outcomes. Well, that's obvious. Everybody and the organization has practiced. The surgeon is really adept at the procedure. So we can drive improvements today. We continue to scale our distribution team. We continue to open new centers. We continue to grow utilization, that's just basically blocking and tackling. And that's just to address the high demand that we have for the patients wanting therapy today. And so you're seeing the growth. You've been seeing it for how many years now, and we're going to continue to push that. And we can do that with the centers that we have, growing same-store sales because we know how to use change practice patterns as you described, to be able to really have the ENTs really focused on the surgery. But I think we also want to highlight where the future is. And I don't know, we just got a couple of minutes, so I want to jump on it. Predictor is a unique opportunity. We did a study of 600 patients. We have the data, been through the biostatistics on that, and we have communicated back with the physicians who are part of that study. And we believe we can identify areas that can help us identify patients who will have the same level of strong outcomes without having to go through a drug-induced sleep endoscopy. And so we're going to be starting to work with payers under disclosure to have them review the data to see if they can let us try that out and change their policy. And once we have a few of those policies going, then we'll continue to add to that going forward. So I think you'll see progress on that even yet this year. But again, to your point, I think you'll see that more so in the long run. But what an opportunity to eliminate dyes for 2/3, if not 3/4 of the patients who have the lower BMIs because that's a 1- to 2-month window that they don't really see the value of that and they can just start moving forward. And the key to us is being able to improve the time to implant. And then finally, on Inspire V, we're working through the operational readiness of V right now. It's in review with the FDA, getting FDA approval is just one step of the process that when we fully launch it, we need to make sure that we're ready to go. We have the proper inventory coming in.

So what -- you soft launch when...

We're looking at still soft launch this year and then full launch next year. It's got to be a seamless move as we go between from soft launch to full launch, and we'll make sure we have the proper inventory levels before we launch it, but that's really going to improve efficiencies, but it's also more importantly, introduces a technology platform for which we can do firmware feature upgrades with -- for years to come.

Got it. I want to touch on GLP-1. We have SURMONT-OSA presentation at the upcoming ADA conference this Friday. We don't know exactly what level of detail we're going to get. But I would love to just maybe hear what was your reaction to the headline data that we saw from that trial? And what are you expecting out of this weekend?

Sure. I think that we know that we stimulate the hypoglossal nerve today, and that moves that base of the tongue forward. And we know that patients who have a higher BMI have more of a lateral wall collapse and patients that were in the SURMONT trial, the average BMI was 39, and the average AHI was over 50, well that is because it's predominantly driven by a lateral wall collapse. We need those patients to lose weight, reduce the lateral wall, reduce their AHI and believe the majority of patients will, therefore, qualify for Inspire and the top line data showed exactly that. So as we come into the data on Friday, we're going to see another level of detail. We look forward to that. We're not even going to guess on that. I think that it's just -- we only have to wait until Friday. But I think we're talking about 2 different mechanisms of action. It's tongue-based versus lateral wall, and we work in partnership with each other. And if you kind of look at the Inspire data over time, both from the STAR trial to the 5,000 patient adhere registry, our BMI hasn't really drifted. We tend -- our average BMI is tend to be around the 29, maybe 30, right? And that's a little bit driven by ourselves because we do sleep endoscopy to make sure patients have the proper anatomy to be able to benefit from Inspire. But it's also a little bit of a function of the insurance companies. We're putting a little bit of a BMI cap. So I think as these GLP-1s help people lose weight and qualitatively, we hear our doctors talk a little bit about patients who did not pass dyes. They're on GLP-1s to try and lose weight and therefore, qualify for Inspire. So we look forward to seeing the data Friday. I think it will clear up a lot of questions that we have. We think GLP-1s are a positive for Inspire, we have said that all along, and we've said that with the discussion around the mechanism of action of lateral wall versus tongue based, I think the data is only going to show further that those patients going to have an opportunity to benefit from Inspire.

So is it fair to say you're less focused on some threshold of a responder rate, which is the percentage of patients below an AHI of 15? Is that just not relevant based on what you just said or...

Yes, we're focused on our business and focused on the demand that we have and the number of patients coming through. And even if the data comes out strong, they still got to get that approved. They still got to work through insurance companies as the practical side to it. And the patients who do follow out the bottom of the funnel never had tongue based obstruction anyways and aren't really in our customer population. So they're -- again, lateral wall versus tongue based. If some of the patients have pure lateral wall and that resolves, that's great for those patients. That's wonderful. But no, I'm not going to put a guess on what I said.

But those are patients you would have been treating anyway.

Yes, because we're tongue based. It's not even in our TAM. So I think the key is going to be look forward to seeing the data and all we got to do is wait until Friday to see the data, so we don't have to go out and guess on what we think that data will be.

Okay. Thank you very much, both of you -- or all 3 for you.

Very good.