Inspire Medical Systems, Inc. (INSP)
NYSE: INSP · Real-Time Price · USD
56.31
-0.04 (-0.07%)
Apr 24, 2026, 4:00 PM EDT - Market closed
← View all transcripts

Stifel 2023 Annual Healthcare Conference

Nov 15, 2023

Jon Block
Managing Director, Stifel

Thumbs up, and we've got a lot to talk about. So Jon Block, with Stifel, and so excited to have Inspire Medical Systems with us.

Tim Herbert
President and CEO, Inspire Medical Systems

Thank you.

Jon Block
Managing Director, Stifel

We've got the full crew: Tim Herbert, President and CEO; Rick Buchholz, CFO; Carlton Weatherby, welcome, Chief Strategy Officer, and Ezgi is not up on stage, but she's out there, I see her, Vice President of Investor Relations. Tim, I just sort of said to you, I'm looking for clarity.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

I think when I speak with investors, that's the common theme I'm getting. So for the quarter, 40% revenue growth off of a mere 77% comp, but not the upside that we sort of have grown accustomed to.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm.

Jon Block
Managing Director, Stifel

I think there was some confusion coming off the third quarter call. On the second quarter call, you sort of said, "Look, we've got a greater percent of Medicare Inspire patients than normal," but you didn't really give the street a definitive reason why. You flagged it, you called it out, but there wasn't a definitive reason why. On the third quarter call, you called out the challenges that you experienced at a certain number of centers with their prior auth submission process.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

Okay? You're running a pilot program with a certain number of customers to try to streamline their prior auth process. Maybe the first question would just be: you got 1,000 centers out there, involved in the pilot. When did that start? You know, what percentage of the 1,000 are on the pilot, and then when did that start?

Tim Herbert
President and CEO, Inspire Medical Systems

Perfect. Thank you.

Jon Block
Managing Director, Stifel

You're welcome.

Tim Herbert
President and CEO, Inspire Medical Systems

It's great to be here. It's great to be here, and, and we love this conference every year, and love being, having the chance to talk to everybody. We like the quarter. 40% growth, that's still pretty impressive, getting up to over $150 million in revenue, and, and certainly we know what's expected of us. We know what's expected of ourselves, and, so we certainly hold that in high regard and, and continue to work hard for everybody. But very happy with the quarter and the way the team performed, but, obviously know that we can do better. Let's back up a little bit on the prior auth.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

We've got to talk a little bit about why you're doing that in the first place, right? And that's really to clarify what's happening there. We're growing up, and part of the maturing process is you need to start to teach independence. And so when we work with our centers, as they do with every normal procedure that you have when you go to see your doctor, that they take care of the prior authorizations for you. And so with neural stimulation, it's the same thing. We did the same thing back in the day, old days of InterStim, when we transitioned from prior auth into teaching independence. Of course, those are all done independently today, for spinal nerve modulation, even spinal cord stimulation. That used to be a very intense prior auth model.

So it's a natural process to be able to teach independence, and then also work to build some more automaticity to it, make it more easier for everybody, so it's a standard submission. The other side to it is, for most patients who are in the sweet spot, in the, they're on label within the policies of the payers, those are routine submissions. So get the right information submitted into the payer. Those can get approved at a greater than 90% clip within 2-5 days. So it lends itself to start the process. So we have to run a pilot program on this first to make sure that we can teach and debug it. So we start with a small single-digit percentage of centers.

Jon Block
Managing Director, Stifel

Of the thousand.

Tim Herbert
President and CEO, Inspire Medical Systems

Of the 1,000 centers.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

Now, you got to remember, there's four quadrants, and so the centers you're going to choose are the centers that have patient throughput. So yeah, the centers we're choosing have a higher throughput, so obviously there's kind of a double multiplier in there that accelerates the pilot, but also helps us identify any challenges we may have earlier.

Jon Block
Managing Director, Stifel

That was in early 2023, that you started that process?

Tim Herbert
President and CEO, Inspire Medical Systems

We started in early 2023, and we started training centers just a few at a time through the first quarter and into the second quarter. And then other centers actually took on, said, "You know, we can do this independently by ourselves." So other centers jumped into this as well, and when we get to the end of the second quarter, and we see a higher mix of Medicare, that's not completely unnatural.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

'Cause we're coming in Q1, we always know is high Medicare, Q4 is-

Jon Block
Managing Director, Stifel

Commercial

Tim Herbert
President and CEO, Inspire Medical Systems

... high commercial, 'cause everybody has the high-deductible insurance programs. They need their Inspire procedure done before the end of the year, before the reset, and then it usually transitions in between. So as we get into the end of Q2, and we see that mix, there's always a still little carryover of the COVID, but we started to really dig in a little bit more. And then what we realized is that we have a logistics challenge, and I'm careful to say logistics challenge, 'cause what we did is have our territory managers actually inspect every site, not just those independent, but really look at where are the - what's the patient flow in there, and we're seeing all these prior authorization files stacked up.

Jon Block
Managing Director, Stifel

That's just sitting with the pilots?

Tim Herbert
President and CEO, Inspire Medical Systems

Right. So we're not, we don't have a challenge with a policy issue, where the bad files are being submitted and rejected. Our challenge is the files are not being submitted, so the patients don't have a chance. So we quickly pulled those back in-house. Our team jumped on them, get those submitted in, and so we saw the big uptick in prior authorizations in the second half of the quarter. But we need to kind of look at the centers.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

Why, why aren't they ready to do this?

Jon Block
Managing Director, Stifel

And-

Tim Herbert
President and CEO, Inspire Medical Systems

Go ahead.

Jon Block
Managing Director, Stifel

Let me just jump in there for a second, and I, I don't want to split weeks and days or even months, but I just want to make sure I have the timing down. When you go ahead, and you intervene because you see the prior auths aren't going through, and that happens, you know, around sort of that, that third quarter, I think on the call you talked about improving trends exiting the third quarter. But those surgeries might take a couple of months to get scheduled, right?

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

So you stepped in, you intervened, you've got your arms around the problem. But did we actually see the surgeries improve exiting Q3, or is that more of a 4Q23, 1Q24?

Tim Herbert
President and CEO, Inspire Medical Systems

I think as soon as you turn the prior authorizations, you can start to see an uptick in surgeries in Q3. The fact of the matter is, we didn't use our capacity in the beginning of the quarter.... right? We used, more so of the capacity when we got to the second half.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

We're a little bit. I hate to use the term of sawtooth, but a little slow in July, but strong in the second half of the quarter, along with the uptick in prior authorizations. That's what gives us the confidence as we're going into the fourth quarter. A lot of the sites, by the way, continue to be independent today. So a lot of the larger sites that have the prior auth team in-house, they can handle this, and they are being successful with it. Smaller centers that don't have the staff to do it or it's it tends to be a job that might have more turnover, so you train somebody, then there's turnover, you gotta train again. There's a little bit of a staffing challenges. Those are the centers that have more of a challenge.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

and that we need to kinda pull back in and build through.

Jon Block
Managing Director, Stifel

So the thought is this isn't being scrapped, this is still certainly the goal for Inspire. It's just, you put the pilot out there, you'll make some tweaks to it or changes to it, and these guys will still eventually stand up by themselves and handle this process going forward.

Tim Herbert
President and CEO, Inspire Medical Systems

But we need to have a deliberate process with it. And so you don't just scale inside with full-time equivalents, so we've contracted with a third-party company, that's what they do, is prior authorizations. And so they have, we're under contract, we have brought them in, they've been trained, they've assigned a number of patients just for Inspire cases. And so all files come to Inspire. The Inspire lead will look at the files. The more routine cases can go to the third party. Anything challenging, a high BMI, a high AHI, a payer who might be more difficult, that will stay in-house with our experts.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

And so we'll be able to streamline the whole throughput, and then as we kinda move on in the future, that third party can kinda help us as a bridge forward.

Jon Block
Managing Director, Stifel

So then let me go back to, you know, you fix or you rectify the problem, you start to see some of that volume-

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm

Jon Block
Managing Director, Stifel

... toward the end of the third quarter.

Tim Herbert
President and CEO, Inspire Medical Systems

Right.

Jon Block
Managing Director, Stifel

The rest of that, that pulls into 4Q 2023, and maybe some into 1Q 2024, because you're fighting the capacity issue?

Tim Herbert
President and CEO, Inspire Medical Systems

Correct.

Jon Block
Managing Director, Stifel

To push there a little bit, what about the ones that go to 1Q24? Because they're commercials, their deductible will reset. Will they proceed in 1Q24, or does that sort of flow a little bit later than that?

Tim Herbert
President and CEO, Inspire Medical Systems

That's the Q4 phenomena, when we always talk about our seasonality. I think the high-deductible commercial cases tend to get a priority in November, December-

Jon Block
Managing Director, Stifel

Get a-

Tim Herbert
President and CEO, Inspire Medical Systems

-to get done, 'cause the patients are really pounding on the table, "Look, you gotta do this before January first, 'cause my $3,000 out-of-pocket reset." So you tend to try and prioritize those at the end of the year, and hence, you see the Medicare kinda get moved more to Q1, hence-

Jon Block
Managing Director, Stifel

Yep

Tim Herbert
President and CEO, Inspire Medical Systems

... the mix.

Jon Block
Managing Director, Stifel

The percentage.

Tim Herbert
President and CEO, Inspire Medical Systems

That's why Medicare goes high in Q1 and commercial is high in Q4. But the doctors and the staff, they work really hard to make sure they try and get those patients scheduled as best as they can.

Jon Block
Managing Director, Stifel

Okay, maybe just one or two more down this particular talk track or path. You know, when we think about your visibility at the time of the earnings call, and I've been getting that question a lot.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

So 3 Q calls, first week in November, you go ahead, or the centers go ahead and they schedule out. When you're sitting there in early November and you come basically in line, but you raise, what's your line of sight? Does that take you out 4 weeks? In the first week of November, are you seeing these schedule? Do you only have 3 or 4 weeks of, call it, sort of, you know, vulnerability before the end of the quarter? What's your line of sight there?

Tim Herbert
President and CEO, Inspire Medical Systems

Well, I mean, you got the holidays, too. I think we already... We know historically, Q4 is a strong quarter for us, right? And we know two of the busiest weeks of the year are the last two weeks of December. And so our teams out there right now are reserving as much OR time as they can get. Do we have pure line of sight? No. Do we know the, how the, how the physicians and how the team and how the patients are motivated to proceed? Yes. And so we know that, while we don't have pure line of sight out that far, we certainly know the number of patients in the pipeline and therefore, have confidence going forward.

Jon Block
Managing Director, Stifel

Okay. And, you know, there's just, even in this short period of time since the earnings call, nothing else has popped up or come to light that you'd say, "You know what? It wasn't all about that prior auth. There was something else out there." You're still very convinced as we sit here today that that temporary weakness, and again, it's a little unfair, 40% growth off a 77% comp, but it's all relative, that was solely a prior auth thing?

Tim Herbert
President and CEO, Inspire Medical Systems

Well, I think that just as we laid out in the earnings call, I think we, changed behavior with the reps, too. But absolutely, we have confidence that we had an acute issue that we're able to go and address, and, we're working with all the centers going forward.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

So yes, confidence going forward, and that's why we, even at having a successful quarter, 40% growth, we're really proud of that, over $150 million, crossed over 50,000 patients treated with Inspire.

Jon Block
Managing Director, Stifel

Wow!

Tim Herbert
President and CEO, Inspire Medical Systems

A lot of positives in the quarter, as well.

Jon Block
Managing Director, Stifel

Okay. Guys, any other questions from the audience down that particular road? I know there was a lot of questions, at least incoming from me on that particular topic. If not, I'm gonna move to that thing called GLP-1. I don't know if you've heard about that.

Tim Herbert
President and CEO, Inspire Medical Systems

What is that?

Jon Block
Managing Director, Stifel

Okay,

Tim Herbert
President and CEO, Inspire Medical Systems

I don't know what that stands for. What's GLP-1?

Jon Block
Managing Director, Stifel

Let me give you a couple metrics-

Tim Herbert
President and CEO, Inspire Medical Systems

Okay

Jon Block
Managing Director, Stifel

... and I'll try to go down a particular road. On Inspire STAR trial, average BMI and AHI was roughly 28 and 29, respectively.

Tim Herbert
President and CEO, Inspire Medical Systems

Yes.

Jon Block
Managing Director, Stifel

Okay? For SURMOUNT-OSA, BMI 38-39, AHI greater than 50.

Tim Herbert
President and CEO, Inspire Medical Systems

Yes.

Jon Block
Managing Director, Stifel

All right? For Inspire, let's fast-forward three or four months, here comes the data. For Inspire, what's a good outcome versus a bad outcome on that data?

Tim Herbert
President and CEO, Inspire Medical Systems

Well, a good outcome is patients go on a GLP-1, and they lose weight, right? Great for the patients, great for their health. They'll feel better. But it's hard to imagine those patients taking a AHI from 50 to less than 20.... because really, the study is set up to really assess the weight loss of the patients. No, it's a sleep apnea study. It's designed to show a reduction in AHI, but it only shows a statistical significance between therapy and placebo in two different arms, with or without CPAP. But it doesn't have a clinical relevant endpoint to it, meaning when we did the STAR trial you referenced, we did a responder rate analysis. You needed to show... It's called the Sher criteria. Sher is S-H-E-R, a doctor that developed this criteria.

Needed to show a 50% reduction in AHI, yet the resultant AHI had to be less than 20. So not only did you have a significant reduction AHI, it had a clinically relevant endpoint being less than 20. Publications over the literature over the years have always shown the cut point for the increased risk of comorbidities or the causal effect of untreated moderate to severe sleep apnea is with a AHI greater than 20. So that's, that's kind of how that bar got set. We like to see patients go further, get down to 10.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

But this, this study isn't gonna test that out, and I think that, what we believe is it will show, a statistically significant reduction in AHI, but I don't think it's gonna be clinically relevant. And what our desire is, the patient will lose enough weight to relieve the lateral wall, such that they can qualify, for Inspire, and we can give them therapy to take them, all the way home to get them treated. Right now, most patients in that study are... wouldn't qualify for Inspire anyways. That's not our market-

Jon Block
Managing Director, Stifel

Yep.

Tim Herbert
President and CEO, Inspire Medical Systems

... right? It's just too high a BMI. They're gonna have too significant of a lateral wall collapse, and most are gonna all have complete concentric collapse during a sleep endoscopy procedure.

Jon Block
Managing Director, Stifel

So, maybe to try to push a little bit there, I mean, it would seem like the great outcome is the BMI comes down to that 28 range, and the AHI reduction is less than 50%. Because if that were the case, then you're dealing with what was sort of the standard patient in STAR-

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm

Jon Block
Managing Director, Stifel

... right? Around those levels. You know, clearly a bad outcome is if the AHIs go all the way down to 15, but what about that level of an AHI of 20? And, you know, we had a panel here the other day, and I'll lead with both the sleep specialist and the surgeon said, "Yeah, even at an AHI of 20, I'm referring them for HGNS.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

But do you think that's really the case? Do you view that patient would still proceed with HG N S therapy after their AHI comes down from, you know, 52 down to 20, 21? Do you lose that patient, or is that still in your sweet spot?

Tim Herbert
President and CEO, Inspire Medical Systems

Well, I think it also has to do a little bit how much weight loss did they have? I mean, how good do they feel? The patients with sleep apnea, they don't... I mean, having 20 events per hour throughout the night, you're not getting restful sleep. Your quality of life is not strong. But you gotta remember, these patients coming from a quality of life a lot higher with a high BMI. So they lose weight, they're gonna feel a little bit better, but that's, that's... They're still gonna be very symptomatic to obstructive sleep apnea. AHI 20 is right in our sweet spot. We get that we're approved for any patient with an AHI greater than 15, and we see quite a few patients in the range 15-25. So I would expect a lot of those patients would go through.

But again, the good news is those patients will feel better.

Jon Block
Managing Director, Stifel

I think in STAR, the lower band was actually 18, right? I mean, in the STAR Trial, you had-

Tim Herbert
President and CEO, Inspire Medical Systems

STAR Trial is a little bit different. STAR Trial, we actually screened patients between the range of 20-50, but then we did another sleep study, post-implant, and then averaged that, and the average was 15-65.

Jon Block
Managing Director, Stifel

Ultimately, they were down to nine, I believe, right?

Tim Herbert
President and CEO, Inspire Medical Systems

In the result.

Jon Block
Managing Director, Stifel

Yep, in the result.

Tim Herbert
President and CEO, Inspire Medical Systems

12 months, yeah.

Jon Block
Managing Director, Stifel

Okay, okay. So you're still very convinced or adamant that at the end of the day, this is a net positive. We're gonna have movements within the funnel. You're gonna have these AHIs that, you know, that are at the lower band. They lose weight. They might go to 15 or below, and they're out. But that really you're gonna have a big amount that fall into the funnel, especially as you work on your label expansion and taking the BMI and AHI, a net positive for you guys.

Tim Herbert
President and CEO, Inspire Medical Systems

We wanna take care of people. We wanna take care of patients, and we have patients that come to our website. You have to go through a little questionnaire. You have to put your height and weight in there, and your BMI is high. The probability of having complete concentric collapse is significant, and you don't wanna give the patient bad news like that. And so we always want to refer them on. And so those patients with a high BMI that get screened out because of complete concentric collapse, because we do tongue-based stimulation, we don't address the lateral wall, that's frustrating. And this is an opportunity that these patients can go on a GLP-1, lose some weight, and relax the lateral wall, such that they can be treated with Inspire. This is an opportunity for us. We really are comfortable with that.

Jon Block
Managing Director, Stifel

and you're comfortable with that, and you've been very consistent conveying that to investors, you know, until... Obviously, I mean all this respectfully, but the stock's down, right?

Tim Herbert
President and CEO, Inspire Medical Systems

Sure.

Jon Block
Managing Director, Stifel

Is there anything the company can do and be more proactive about any data that you can gather, that you can show greater evidence...

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm

Jon Block
Managing Director, Stifel

... as to why this is a net positive? Some of the diabetes guys have tried to go down that road, but is there anything at your disposal, not imminently, but over the next 6 to 12 to 18 months, where you might be able to strengthen that argument?

Tim Herbert
President and CEO, Inspire Medical Systems

Sure, and so, our Dr. Schwartz, the Chief Medical Officer, is working with our advisory committee. We have both the ENT and a sleep advisory committee, and they're looking at the history of weight loss and how that applies into Inspire. One example is a doctor that we have in Florida who is a sleep physician, but also manages a weight management clinic, and so he has experience with patients on bariatric surgery, losing weight, and being able to refer them over to the ENT, and they've received Inspire. He's had cases where they've failed the sleep study because of complete concentric collapse, whereby they were prescribed a GLP-1, lost weight, and now qualified and have received Inspire. So there is some evidence, although you're talking a very low number today.

So they are working together to begin to start to digest this, weight loss and the benefits for reduction in sleep apnea, and how do we help patients get qualified for it? So they're working on that, and we're gonna be looking to put something out in the near future to help clear up what our thoughts are on this.

Jon Block
Managing Director, Stifel

Okay, and just to put a bow on SURMOUNT-OSA, I mean, the thought is anything north of 20 or above is, is a positive. If it were 25 or above on AHI, pardon me, that's sort of closer to a home run because you're in that streamline STAR sort of characteristic.

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah, but what if it's 35? I mean, we have to look at the data from this past weekend. It didn't show a significant weight loss, but it also showed a more of a non-compliance.

Jon Block
Managing Director, Stifel

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

And so we have to watch that and when the AHI, depending upon where that mean comes to, we feel comfortable with that, and we wanna be there to help those patients if we can.

Jon Block
Managing Director, Stifel

Okay, let's get off prior authorizations and GLP and Inspire V.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

So you've been excited about that for years now.

Tim Herbert
President and CEO, Inspire Medical Systems

Still am

Jon Block
Managing Director, Stifel

... and still very excited and, you know, submission to the FDA. The timeline seems to get pushed a little bit by 6-9 months in the earnings call. You're talking about sort of the full rollout in 2025. Just talk about the extent of the questions back from the agency.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm

Jon Block
Managing Director, Stifel

... and then where you guys are gonna go, you know, from here.

Tim Herbert
President and CEO, Inspire Medical Systems

Sure. We submitted at the end of Q2, which was great. 13,000-page submission. It's a Class III active implantable device. It's a complex submission. We give our partners at the FDA a lot of credit. They really worked through that. And remember that first risk of government shutdown? They got us the questions right before the day before the government was supposed to shut down, and then afterwards, we kinda worked with them interactively to kinda clean up a lot of the questions 'cause they really worked hard to get that out. And so a lot of it is the questions are just kinda clarifying what's in the submission. So that's the first group.

There's always questions that come around biocompatibility of the device, but you gotta remember, the Inspire IV device, really all we're changing, going from IV to V, is the circuit card inside. There's not a lot of other material that's exposed to the body. So biocompatibility we'll be able to handle. Electromagnetic compatibility, can it work in a noisy environment, is another standard set. So really, no major surprising questions that we saw. But because with the FDA, we're gonna submit, and we're gonna have a full package ready to go, meaning we're gonna have our production fully qualified, all the test equipment, qualified, fully documented. So the package that we send in early in the year is gonna be a complete package that they're gonna be able to review. It's a range of time.

If they hold the same clock, it could get approved in the second quarter. If it, if they go reset the clock because of the extensive review, could go to Q3. But we're gonna be doing a limited market release before a full launch, and the limited release is we're gonna be interfacing with the patient remote, with the new physician programmer, with Inspire SleepSync, right? And so we're gonna make sure across the board, everything is working fine. Remember going from Inspire, I'm sorry, from three incision-

Jon Block
Managing Director, Stifel

Yep

Tim Herbert
President and CEO, Inspire Medical Systems

... to 2 incision, and that converted so quickly. We believe when we come out with 5, it's such a significant improvement, we're gonna see an immediate conversion. We're gonna see everybody gonna wanna transition over. So we're gonna do a limited launch, make sure everything's lined up before we do the full commercial. Hence, that's why we kinda just said, "Look, we're gonna talk about the full commercial in 2025, but, we're gonna gain a lot of experience in 2024 to be ready to go.

Jon Block
Managing Director, Stifel

Can you talk about, you know, your expectations in terms of surgeons' time or the reduction, the savings, moving from or going over to Inspire V? And it's funny, I, you know, had scribbled down. Just remind us of what took place when you went from three-incision to two-incision.

Tim Herbert
President and CEO, Inspire Medical Systems

Well, just to remind everybody, we used to do three incisions. So you'd do one incision for the stimulation lead, one for the neural stimulator, and we'd go down to the fourth or fifth intercostal space, where we made the incision for the pressure sensor. And the physicians wanted to ease that. So the ENT physicians led the challenge to, "Let's put that up in the same pocket as where the neural stimulator is," so we could only do two incisions. Once we got the data on that and got confirmation with FDA, that converted to every physician doing two incision, probably within one quarter. So I think the same thing's gonna happen with Inspire V. Today, the average time is between 60 and 90 minutes to do an Inspire IV procedure.

We believe as we go to Inspire V, that could go down to 45-60 minutes, so it's a significant cost savings. But that's not the most of it. What's the most important factor, I think, is remember, we have ear, nose, and throat surgeons, right? While they do this procedure, putting the sensor in the chest between the intercostal muscles, it is the one kinda unnatural, uncomfortable part of the procedure. It's safe. And they get trained, they do it. It's not an issue. We've done more than 50,000 cases. But if they could have that internal sensor, that's gonna give them just a little bit more confidence going forward, too.

Jon Block
Managing Director, Stifel

So, you just nailed what went on at the panel yesterday, right? The doc, the ENT up there, said, "Look, I'm gonna be able to shave about a third of my time," he thought, with Inspire V-

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm

Jon Block
Managing Director, Stifel

... which sort of foots to your comments. And then I asked him, you know, he'd been implanting you guys for a number of years, but, hey, is this gonna bring another slew of surgeons? Because the procedure is simplified, and he said, "Absolutely." And, and if I think about new surgeons and reduced time, and he threw out a number where he thought he can do an extra procedure a week, you know, if he could get the surgical times down by a third.... These are drivers for freeing up capacity-

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

-now in 2025, though, right? And you're fighting capacity sort of three Q4, Q23.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm.

Jon Block
Managing Director, Stifel

Help us get comfortable with what the company can do. I mean, you're gonna add your centers, but what are the drivers to free up capacity in 2024 to sort of bridge you to Inspire V and freeing up time from that event?

Tim Herbert
President and CEO, Inspire Medical Systems

Sure. Many things. We've got so far as I'll have to talk to the surgeon you had on panel yesterday, but they, we-- this sounds ridiculous. We do time studies. Where is the ENT? Where do you spend your time? If I'm asking for half of your practice to do Inspire cases, and you work 40 hours a week, I know you work a lot more than that. I mean, theoretically, we only get 20 hours a week to work with. We've somehow got to make sure that most of that time's in the operating room doing procedures. So we have to assess what other elements of the Inspire procedure have to be taken care of by somebody else. And a practitioner in the office can handle a lot of the diagnostics, the patient flow.

We have patient navigators to help them through the whole process. The key individual is having a sleep physician that can help with the diagnosis, but can also do all the longitudinal management, right? And with SleepSync, the ENT is still engaged on how their patients are doing, but they know they're comfortable that the sleep physicians are managing their patients, so they can focus on doing surgery. So that's one, just pure efficiency in their practice. Two is telling them that we got to train their partners. Every ENT practice-

Jon Block
Managing Director, Stifel

Sure

Tim Herbert
President and CEO, Inspire Medical Systems

... has how many ENTs in there, and to think one surgeon says, "I got it all. I can do all this." No, it's more important that we train their partners, so, one, they have a backup, but two, multiple surgeons can do the procedure to offload and reduce the pressure. And then going forward, we talked about Predictor. Predictor, we believe that most patients will not have to have a sleep endoscopy, even though CMS helped us out by doing a tenfold increase in reimbursement-

Jon Block
Managing Director, Stifel

Sure

Tim Herbert
President and CEO, Inspire Medical Systems

... recently. That's also a procedure that we would rather have the ENTs doing implant procedures than we would doing sleep endoscopies, and we'll continue to open new centers as well.

Jon Block
Managing Director, Stifel

Okay, so you have those near-term initiatives. One thing that I didn't hear you mention, Tim, just there, were the ASCs, right?

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

The ASCs, I think earlier on, you talked about increasing that as a percentage of the overall facilities. I think it's around 23%.

Tim Herbert
President and CEO, Inspire Medical Systems

Mm-hmm

Jon Block
Managing Director, Stifel

... and it's been in and around that number now-

Tim Herbert
President and CEO, Inspire Medical Systems

Hovers there. Yep

Jon Block
Managing Director, Stifel

For the past 6 or 7 quarters. Is this a, you know, a rate thing? How do you move that number higher? 'Cause that obviously, that could help aid capacity.

Tim Herbert
President and CEO, Inspire Medical Systems

We're gonna have a whole project starting on this, but it's really a reimbursement thing. It's really more a CMS thing.

Jon Block
Managing Director, Stifel

Yes.

Tim Herbert
President and CEO, Inspire Medical Systems

The challenge is, is while Medicare will reimburse fairly in the major cities and primarily in the north here in New York, the ASCs pay very, very well. You get into the south, into Mississippi and Alabama, it can put the ASC into a loss position with Inspire, and that's gonna create a challenge. It all is based on the way that CMS does device-dependent procedures, where they discount not only the labor rates, but they discount the material as well, and that's unfair. So that's gonna be a longer-term project. And how do we handle the reimbursements from a Medicare standpoint? Most ASCs can handle commercial cases if they have a contract. They have to do individual contracts, United, Anthem, Aetna.

Once they get them in place, it is a profitable position for the ASC, but it's difficult for a surgeon to say, "I'm gonna do all the Medicare at the hospital, and now I'm gonna take all the private over to my ASC-

Jon Block
Managing Director, Stifel

Yeah

Tim Herbert
President and CEO, Inspire Medical Systems

Where it's profitable. The hospitals push back on that a lot.

Jon Block
Managing Director, Stifel

Not big fans of that. Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

We got a lot to do on that, but I think long term, ASCs will play, but we do have to fix the reimbursement challenges.

Jon Block
Managing Director, Stifel

All right, let me see what else I can push on in three minutes. And Rick, I'm gonna go over to you, and you know, again, the model's not up here, but when I look at my estimates, the guidance you know sort of implies U.S. utilization of flattish year-over-year for the back half of 2023. I actually had the third quarter, where utilization, we might all count it slightly different, but utilization for the third quarter was up low single digits, and the fourth quarter's implied flattish, right? And I don't want to make it out to seem like it's a low bar, but 4Q utilization's implied flat, 3Q was up low single digits. But Tim, to your point, you didn't really use a lot of the capacity that you had in 3Q.

Rick Buchholz
CFO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

How do I think about that, and is that sort of lend itself to maybe a small layer of conservatism?

Rick Buchholz
CFO, Inspire Medical Systems

Well, we haven't changed our guidance philosophy at all, and we're really focused on scheduling that procedure time and getting OR time before those high deductibles reset. So we're gonna continue to focus on, you know, we've worked through the prior authorization issue. We're scheduling those cases. We saw a robustness in the second half of the quarter, and that gave us confidence to raise our guidance, despite, you know, Q3. And so, no, we're excited at the opportunity to, you know, close out the year strong.

Jon Block
Managing Director, Stifel

Okay. Maybe I'll jump over to a slightly different topic. After the third quarter, your 2024 numbers came down a smidge, but I mean, in the first time since I've been covering you guys, really was the first time the out year, you know, came down. But you got a lot of tailwind still as we go into 2024, and the commercials and BMI goes up, and AHI goes up, and pediatric Downs, and there's international opportunity-

Rick Buchholz
CFO, Inspire Medical Systems

Mm-hmm

Jon Block
Managing Director, Stifel

... then the background's gaining some traction. So let me just, you know, when we think about the BMI and the AHI and taking those up at some of the commercials, you already knocked down a couple. What does that mean for utilization? Let's pick a utilization number per center this year, 23. What... You know, are those a couple of extra procedures per center just attributable to BMI, AHI, pediatric Downs?

Tim Herbert
President and CEO, Inspire Medical Systems

Efficiencies and experience. As surgeons do more cases, they become more proficient with the procedure. Top surgeons are doing it within an hour now. I think all of it is additive. Right? We're gonna have continued technology advancements as well with the digital, just to streamline the whole patient flow. So yeah, we're gonna continue our pathway opening new centers, but that's gonna be a lesser percentage of the overall number of centers. So the growth is gonna come from the higher utilization from the same-store sales.

Jon Block
Managing Director, Stifel

I'd like a soft commitment that when we look to 2024, it should be still another robust year of utilization growth at the centers.

Tim Herbert
President and CEO, Inspire Medical Systems

Correct.

Jon Block
Managing Director, Stifel

Okay. And then, you know I'm gonna run down the clock as much as I can. Just quickly, Rick, help us out with the points of leverage, which is another area that some investors will focus on, and maybe I'll quickly work my way through. GM, with Inspire V, you eliminate the lead, maybe you take some price. GMs would seem to have an up arrow in that regard. R&D's running really hot right now as you finish Inspire V, and you're actually bringing down some of those expenses. And then SG&A, Tim, you've talked about a little bit more of a targeted approach-

Rick Buchholz
CFO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

That doesn't mean the number comes down, but it's more targeted.

Rick Buchholz
CFO, Inspire Medical Systems

Mm-hmm.

Jon Block
Managing Director, Stifel

All three of these are areas of leverage that we can think about longer term?

Rick Buchholz
CFO, Inspire Medical Systems

Yes, but I think the real driver is the fact that we're really still early in the commercialization. You know, our utilization rate per center is under two procedures per month. So the real driver, we're gonna continue to make investments, but, and we've shown leverage. We're gonna continue to drive utilization, try and increase that number of procedures per month. With our 84% gross margins, that will, you know, drive further profitability or towards profitability and more leverage, and that's the real focus for us in 2024.

Tim Herbert
President and CEO, Inspire Medical Systems

I love the running out the clock. That's great. We'll keep going on the overtime. Touch on, touch on DTC. I mean, DTC, you mentioned on it, and the key is maintaining our direct-to-patient awareness campaigns, and that really is an effective way to educate them. But we have learned so much since the early days of news, print, and radio, then we went to social media, then we made a TV commercial and started local TV, and then we did some national buys. We're taking the next step to be, can I use the term surgical? To really talk about using direct advertising to really target our demographic, thereby getting higher yield on the inbound patients inquiring. So we're not going away from direct-to-consumer. We're not cutting back on it.

What we're doing is continue to educate, refine our programs to get a higher yield and still keep the same quality of patients going to our centers.

Jon Block
Managing Director, Stifel

Okay. And we've gone well over-

Powered by