Inspire Medical Systems - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 exceeded Street expectations: revenue $201.3M vs $194.9M consensus* and diluted EPS $0.10 vs -$0.23 consensus*, on 23% YoY growth and 84.7% gross margin; management reiterated FY revenue ($940–$955M) and raised EPS to $2.20–$2.30, citing Inspire V full launch and operating leverage.
• Q2 flagged as a “transition quarter” as centers amend contracts, adopt the new programmer, and work down Inspire IV inventory; sequential revenue growth guided to mid- to high-single digits and profitable, but below current EPS consensus, with stronger 2H and especially Q4 anticipated.
• Coverage and reimbursement for Inspire V progressing: CPT 64568 now incorporated into policies covering ~80% of >300M covered lives (commercial, Medicare, VA), with ASC reimbursement uplift; management views physician economics as time-adjusted neutral-to-positive given shorter OR times.
• Cash/investments of $414M (down from $516.5M at YE) reflect $75M ASR and inventory build to support Inspire V; tariff exposure de minimis; tax rate ~10% and diluted shares ~31M guide maintained.
• Stock narrative catalysts: Inspire V U.S. full launch execution (capacity gains, surgeon uptake), 2H utilization trajectory, and FY guidance durability vs Street estimates (Street FY EPS and revenue materially below guide, implying potential upward revisions)*.

Note: Asterisked values are from S&P Global consensus.

What Went Well and What Went Wrong

• What Went Well

  • Demand and execution: revenue +23% YoY to $201.3M with 84.7% gross margin and a swing to diluted EPS $0.10 (vs -$0.34 YoY); Adjusted EBITDA rose to $33.2M (16% margin), evidencing operating leverage.
  • Product cycle: “We are now ready to launch the Inspire V system and look forward to initiating the full launch this month in the U.S.”; management highlighted strong surgeon reception and shorter procedures reducing constraints.
  • Guidance quality: FY revenue reiterated ($940–$955M) and FY EPS raised to $2.20–$2.30, supported by expected 2H ramp as V adoption expands.

• What Went Wrong

  • Q2 air pocket: Management warned of a transition quarter driven by contract amendments, programmer roll-out, Inspire IV inventory burn-down, and some patient warehousing ahead of V; Q2 EPS expected below consensus despite sequential revenue growth.
  • International softness: OUS revenue fell 6% YoY to $7.7M in Q1 as 2024 Q1 had benefited from post-EU MDR approval catch-up; FX neutral in Q1 but some FX headwinds expected in Q2.
  • Balance sheet draw: Cash/investments declined to $414M, reflecting a $75M ASR and inventory build to support V full launch (prudent, but reduces optionality near-term).

Transcript

Speaker 12

Good afternoon. My name is Dilem, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Inspire Medical Systems First Quarter 2025 conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I will now hand the call over to your first speaker, Ezgi Yagci, the Vice President of Investor Relations at Inspire. You may begin the conference.

Speaker 8

Thank you, Dilem, and thank you all for participating in today's call. Joining me are Tim Herbert, Chairman and Chief Executive Officer, and Rick Buchholz, Chief Financial Officer. Earlier today, we released financial results for the three months ended March 31, 2025. A copy of the press release is available on our website. On this call, management will make forward-looking statements within the meaning of the federal securities laws. All forward-looking statements, including without limitation, those relating to our operations, financial results, and financial condition, investments in our business, full year 2025 financial and operational outlook, and changes in market access are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements.

Please see our filings with the Securities and Exchange Commission, including our Form 10-Q, which we filed with the SEC earlier this afternoon, for a description of these risks and uncertainties. Inspire disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, May 5th, 2025. With that, it is my pleasure to turn the call over to Tim Herbert. Tim?

Speaker 7

Thank you, Ezgi, and thanks everyone for joining our business update call for the first quarter of 2025. We achieved many important milestones to start the year. As our patients remain our top focus, we are proud to announce that since the inception of Inspire, we have surpassed 100,000 patients who have received Inspire therapy. Even with this key milestone, there is so much more in front of us as we remain lightly penetrated in our target market, and we are just getting started. We also recently announced the appointment of Dr. Paul Hoff and Dr. Rahir Patel as Vice Presidents and Senior Medical Directors. Dr. Hoff and Dr. Patel are both highly experienced in treating sleep apnea patients, including with Inspire therapy. Dr. Hoff brings a focus from the ENT surgeon's perspective, while Dr. Patel will leverage his expertise in sleep medicine.

They will play key roles in guiding Inspire's medical education, training, and technology development activities. In addition to their focus on these newly appointed positions, both Dr. Hoff and Dr. Patel will maintain their clinical practices independent from Inspire. In the first quarter, we continue to expand the limited market release of the Inspire 5 system in the U.S. and with this gain meaningful experience with Inspire 5 while concurrently solidifying our inventory levels. As such, we are incredibly excited to announce that we are ready, and we will begin the full launch of the Inspire 5 system in the U.S. this month. The Inspire 5 system kickstarts the next generation of therapy with the release of this new platform. Incorporating sensing into the neurostimulator provides a stable sensing environment, which is key to our differentiated closed-loop hypoglossal nervous stimulation system.

The added technical capabilities of the device provide the basis for future therapy enhancements, including sleep detection and broader therapy indications. From a financial perspective, we had a strong first quarter generating revenue of $201.3 million, representing a 23% increase compared to the first quarter of 2024. Net income for the first quarter was $3 million, represented diluted net income of $0.10 per share, as compared to a net loss of $10 million, representing a net loss of $0.34 per share in the first quarter of 2024. Looking forward to the balance of 2025, we are reiterating our full year 2025 revenue guidance of $940-$955 million, representing 17%-19% growth year over year. Regarding profitability, we are increasing our full share diluted net income guidance to be in the range of $2.20-$2.30 per share.

As we initiate the full launch of the Inspire 5 system, we anticipate the second quarter will be a transition quarter as we work through the steps necessary to launch this system. For centers, this process includes a contract amendment, implementation of the new physician programmer, and working through their Inspire 4 inventory. Our experience to date with the Inspire 5 system has been very positive and well received by healthcare providers, especially with ENT surgeons. Since the start of the limited market release last year, we have continued to add additional centers and increase the number of patients receiving the new device. This led to an increased general awareness of the pending Inspire 5 launch. Late in the first quarter and continuing into the second quarter, we started to see evidence of patients waiting for the new device.

Combining this with centers working through the launch process, we expect the second quarter to be a transition quarter and for revenue to grow mid to high single digits sequentially. As the full launch of Inspire 5 system progresses, we expect a strong second half of 2025, and as such, we are reiterating a full year revenue guidance and raising our EPS guidance. Detailed performance data of the Inspire 5 system is being closely tracked, and initial data will be presented at the upcoming sleep conference. Regarding reimbursement of the Inspire 5 system, on our last call, we detailed the transition to CPT code 64568. We are happy to announce that this code has been incorporated into policies covering approximately 80% of our over 300 million covered lives. This includes commercial payers, Medicare, and the VA system.

We expect to submit for regulatory approval of the Inspire 5 system in Europe and in Asia this year and will continue to provide the Inspire 4 system during the review processes. We also plan to initiate a focused patient marketing and education program to announce the full launch of the Inspire 5 system. Prior to launching Inspire 5, we had deliberately pulled back on patient marketing, but expect to step this up in the second quarter and throughout the rest of 2025. This will focus on the education and awareness of the Inspire 5 system and aim to increase patients visiting our website and inquiring about making contact with a healthcare provider. To further support this, during the early part of the year, we continued our efforts to expand utilization of digital scheduling with implanting centers.

As a reminder, digital scheduling is an online tool used by our Advisor Care Program to submit appointment requests to qualified healthcare providers on behalf of prospective patients. Digital scheduling significantly streamlines a patient's request to schedule that important first appointment. With respect to our market development activities, we continue to advance our medical education programs. In the first quarter, we hosted over 300 physicians at Inspire programs, including 120 soon-to-be graduating ENT physicians, over 110 sleep fellows, and introduced Inspire therapy to 90 new ENT residents. We remain committed to our mission to educate the next generation of sleep and ENT leaders. In addition, this year, we trained over 100 advanced practice providers, bringing the total inception to date to over 400 APPs trained.

We plan to increase the investments we are making on our medical education programs, including ongoing resident fellowship and APP training, participating in cardiology and primary care conferences, and a continuing medical education program to support the awareness and adoption of Inspire therapy in cardiology and primary care. In summary, we remain focused on the patient to continue the growth and adoption of Inspire therapy. We will execute our growth strategy of driving high-quality patient flow and increasing the capacity of our provider partners to effectively treat and manage more patients. Our key strategies included adding advanced practice providers, certifying additional surgeons qualified to implant Inspire therapy, and driving the adoption of SleepSync and our digital tools, all of which are embedded strategies in our commercial team's objective to increase provider capacity.

Looking ahead, we remain excited about our future and are confident that we have the appropriate strategy in place to drive long-term stakeholder value. With that, I'd like to turn the call over to Rick for his reviews of our financials.

Speaker 0

Thank you, Tim, and good afternoon, everyone. Total revenue for the quarter was $201.3 million, a 23% increase from the $164 million generated in the first quarter of 2024. U.S. revenue in the quarter was $193.6 million, an increase of 24% from the $155.8 million in the prior year period. Revenue outside the U.S. was $7.7 million, which was a 6% decrease year over year. As a reminder, European revenue in the first quarter of 2024 benefited from the pent-up demand created by the supply shortage resulting from the EU MDR approval delay in the fourth quarter of 2023, and as we transitioned from polyurethane to silicone-based leads. Gross margin in the quarter was 84.7%, which was stable with the prior year period. Total operating expenses for the quarter were $172.1 million, an increase of 11% as compared to $154.5 million in the first quarter of 2024.

This planned increase was primarily due to the expansion of our sales organization and increased general corporate costs, partially offset by a reduction in R&D and patient marketing expenses year over year. Interest and dividend income totaled $5.1 million in the quarter compared to $5.9 million in the prior year period. Operating loss for the quarter totaled $1.5 million compared to $15.2 million in the prior year period. Net income for the quarter was $3 million, or a 1% net income margin compared to a net loss of $10 million, or a 6% net loss in the prior year period. This represented diluted net income per share of $0.10 compared to a net loss of $0.34 in the first quarter of 2024.

Adjusted EBITDA totaled $33.2 million, or a 16% adjusted EBITDA margin in the first quarter compared to $11.9 million and 7% respectively in the first quarter of 2024. The weighted average number of diluted shares outstanding in the quarter was 30.5 million. We ended the quarter with $414 million in cash and investment balances. The reduction in our cash position is attributed to $75 million of share repurchases and cash used in operating activities, including building Inspire 5 inventory balances. This strong cash position allows us to remain focused on executing our growth strategies. Moving on to 2025 guidance, we continue to expect full year revenue to be in the range of $940-$955 million, representing an increase of 17%-19% compared to full year 2024 revenue. As Tim noted, we are initiating the full launch of Inspire 5 this month.

As such, the second quarter will be a transition quarter, and we may see some inventory destocking of Inspire 4 and patient warehousing for Inspire 5. Therefore, we expect to grow revenue sequentially from Q1 to Q2 by mid to high single digits. We continue to expect full year gross margin to be in the range of 84%-86%. We now expect diluted net income for the full year 2025 will be $220-$230 per share, an increase from our previous range of $210-$220 per share. We ended the quarter with 343 U.S. territories and 245 U.S. field clinical representatives. We continue to expect our reported tax rate in 2025 to be roughly 10%, primarily related to state and local taxes. We expect the full year diluted shares outstanding to be approximately 31 million.

As previously noted, our products are currently sourced and assembled primarily in the U.S., and our exposure to recently implemented tariff policies is de minimis. In conclusion, our strong performance and business momentum provide us with confidence in our outlook for 2025. With that, our prepared remarks are concluded. Dulan, you may now open the line for questions.

Speaker 12

Thank you, sir. As a reminder, to ask a question, you will need to press star 11 on your telephone. To withdraw your question, please press star 11 again. We ask that you please keep your questions to no more than one question and one follow-up, and if time permits, we will be more than happy to take more questions. Please stand by while we compile the Q&A roster. I show our first question comes from the line of Travis Steed from Bank of America Securities. Please go ahead.

Speaker 10

Hey, thanks for taking the question. First, congrats on profitability this quarter, but actually wanted to focus on the Q2 revenue guidance and the destock and the patient warehousing that you mentioned. I think it's in the 10-K as well or 10-Q. First of all, maybe just like what happened kind of versus expectations there. Is the impact in the quarter basically the kind of $12 million delta between your 2Q guidance and the street number? How do you rate the full year guidance? Do you expect that to kind of be made up in Q3 and Q4 to be able to rate the full year guidance?

Speaker 7

Yeah, hi, Travis. I think as we started to expand the Inspire 5 limited market release, word got out, and the awareness of the technology and the pending launch became more prevalent, and we started to see more of the patient warehousing. We knew as we were going to launch Inspire 5, there would be a transition period with centers working through the contracts, working through getting the new physician programmer, as well as working through their Inspire 4 inventory. That is why we expect with the number of patients waiting for therapy with the 5 until such time as it's available, that we would see the second quarter affected. That is why we'll still see a good step up in Q2, but as we mentioned, in the mid to high single digits.

Yes, we do plan to make that up throughout the year as we continue the launch and grow the utilization of Inspire 5.

Speaker 10

Great, thank you.

Speaker 7

Thanks, Travis.

Speaker 12

Thank you. I show our next question comes from the line of Danielle Antalffy from UBS. Please go ahead.

Speaker 1

Hey, good afternoon, guys. Thanks so much for taking the question. Congrats on a really strong start to the year. Just if I could follow up on the cadence commentary for the year, I guess how much confidence do you have in as far as how much Inspire 4 inventory is in the marketplace right now? I guess sort of that number you're putting out there for Q2 and that you can sort of make up for some of that in Q3 and Q4. Just curious about what level of visibility you guys have into that and how confident can we be? Because obviously back half loaded guidance can sometimes make people a little nervous. Just wondering if you could give a little bit more color. Thanks so much.

Speaker 7

Absolutely, Danielle. Thank you very much. We have close knowledge of the inventory on the field. The majority of centers only have a couple of units on the shelf. Those centers that are the high volume centers will have a higher number of Inspire, but they also do, they tend to be the quartile one centers that do a significant number of implants on a monthly basis. They will be able to work through the majority of that inventory in a short period of time in the second quarter. Once they work through that Inspire 4 inventory, there is a replacement with the Inspire 5 inventory.

We do have confidence in the back half of the year as we continue to wrap and expand the full launch of 5, but we do have to closely monitor existing 4 inventory, and that's why we have confidence that the majority of the units and the inventory burndown will be accomplished in the second quarter.

Speaker 1

Thank you.

Speaker 12

Thank you. I show our next question comes from the line of Robbie Marcus from JPMorgan. Please go ahead.

Speaker 14

Oh, great. I'll add my congratulations on a nice quarter. Sorry to keep on this, but maybe just a follow-up on the question there. Is the way we should be thinking about this, you had very good procedure volume growth in sales in first quarter. There's some lower number of procedures in second quarter, call it the $10 million-$15 million that's lower than the street, but maybe not quite as much as that because you're eating into existing inventory. We'll get that restocking in third and into fourth quarter. I guess the question I really have is, how should we think about the balance of restocking and how should we think about the sizing of the pent-up demand and is the system ready?

Is it a big amount of patients that are being warehoused that give you the confidence in the back half of the year and it's just you're seeing some bleed down of inventory and some delay of procedures and that's why you're not raising guidance for the year?

Speaker 7

Gotcha. Thanks, Robbie. Great question. Getting into detail, the first thing that's always strong is the patient outcomes and our awareness programs. The patient funnel always remains strong. We continue to add centers, we continue to grow the utilization, and we continue to help patients make that first connection. The front of the funnel remains very, very strong, and that's what gives us confidence going forward. We do know that we have to work the process of activating these centers, and we do have to burn down the Inspire 4 inventory, but the key is to continue to grow the number of implants.

You kind of hinted at that in your question that, yes, we're going to still do implants with Inspire 4 in the second quarter, but you're going to see a little bit of a shift until the Inspire 5 inventory comes in and replaces that. While we are doing the full launch this month, there is a little bit of a transition process for centers to get up and running with 5, but the strength that we have is the demand with the patient flow remains very, very strong. That's what's really encouraging to us as we lean forward and have confidence going into the second half of the year.

Speaker 14

Great. Thanks a lot, Tim.

Speaker 12

Thank you. I show our next question comes from the line of Adam Maeder from Piper Sandler. Please go ahead.

Speaker 9

Hi, good afternoon. Thank you for taking the questions and congrats on a nice quarter and the full launch of Gen 5 this month. I wanted to ask maybe just one more on Gen 5, the level of confidence that you have to kind of take that next step from a launch standpoint, really, just around manufacturing, reimbursement, and device performance. Presumably, you're pleased with the progress you've made in each of those different areas, but there has been some speculation around why the rollout hasn't gone faster. Just wanted to give you the opportunity to add a little bit more color there with what you're seeing and the progress that you're making in those different areas. Thank you.

Speaker 7

Okay. Sure, Adam. Thanks very much. First off, the device is fully approved. We submitted to the FDA the full data set that we had, the full qualification, and it has been under tight review, and we're very confident in the performance of the device. We have done the work in Singapore, as you recall. We have done a significant number of centers and implants in our limited market release. Full confidence in the product moving forward. The challenge that we had is ramping up the manufacturing facility to have standard processes such that we could have the throughput and the starting inventory to support the full launch. We do a significant number of implants on a monthly basis, more so than we did, obviously, when we did Inspire 4 back in 2018.

We needed a strong inventory level to do the full launch, and we now have stable manufacturing. We do have good inventory levels. We've always had confidence in the Inspire 5 technology, and we're really liking the response that we're seeing from the healthcare providers, specifically the Inspire 5 experienced surgeons who no longer have to implant the pressure sensing lead, which we all know has been the most uncomfortable step of the process for Inspire implanting with the ENT surgeons. We just needed to make sure that we were ready, that we had all the key elements in order.

From a technology to a product to the approval to the reimbursement, as we mentioned, and the support with the policies with the new code 64568, and finally with the proper inventory levels, we're ready to throw the switch and be able to move into full launch.

Speaker 14

Thanks, Tim.

Speaker 7

Thanks, Adam.

Speaker 12

Thank you. I show our next question comes from the line of Richard Newitter from Truist. Please go ahead.

Speaker 9

Hi. Thanks for taking the questions. Nice first quarter here. Maybe you can frame for us the reiterated revenue range for the year. One, when you originally provided that guidance, what was assumed or were you assuming any transition situation that would require kind of inventory workdown? Then B, can you talk to the bottom and top ends of your range right now? We're just trying to figure out what kind of cushion is built in and how much you ate into what normally is a cushion-provided guidance range. If you could just talk to what gets you to the upper end, what gets you to the lower end with respect to the various components of capacity, Inspire 5, and enabling increased capacity, and kind of some of the dynamics now that you're introducing with the 2Q revenue push-out. Thank you.

Speaker 7

Gotcha, Rich. The key is from a full year, we have not changed. We still have confidence in that full year. We knew we were going to do an Inspire 5 launch during the year sometime, and we would be working through the inventory. Not a lot of change there. What is clarifying here is our ability to do the full launch right now. With our limited release, we saw a little bit more of the patient awareness and wanting to wait for the new device. I think that has become evident really most recently, late Q1 and into the second quarter that we started to see that. That kind of shifts the mix of or the timing of the revenue and where Inspire 5 comes in. Not a lot of changes in our overall annual planning.

Again, we knew we were going to work through the Inspire 4 inventory. It's just a timing issue as we do the full launch in the second quarter. Hand off to Rick for additional comments.

Yeah. We did say at the beginning of the year that we did expect our full year revenue to be a little more heavily back-end weighted. Given the Q2 launch dynamics, as we talked about, we are expecting some utilization improvements in the second half. We expect Q4 to be a little bit stronger than our historical levels.

Speaker 12

Thank you. I show our next question comes from the line of Kallum Titchmarsh from Morgan Stanley. Please go ahead.

Speaker 9

Yeah. Thanks for taking the question, guys. From your initial rollout of Inspire 5 in the limited launch, I assume the majority of these surgeons were sleep specialists, but I'm curious if you were able to target any of those generalist ENTs that you think could eventually be the driver of a broadening surgeon pool. Just maybe talk us through how you plan on onboarding these generalist ENTs as you enter the full market launch in May and how that may differ from your strategy with the bulk of active implants of today. Thanks a lot.

Speaker 7

Oh, absolutely. Thank you. I think the key is when we do new launches like this, when we do clinical studies, when we do research, obviously we partner with a lot of our key physicians at the academic centers. In our limited market launch, in that it is a commercial launch, albeit limited, we do want to involve the commercial centers and the general practice ENTs to get a good balance when we do that limited launch. It is a balance between the two groups, both academic as well as the general ENTs, and that gives us confidence to move forward with the full launch of Inspire 5. We have had the ability to talk with both groups and have confidence with our training programs. As we introduce 5 broadly in the U.S., the training programs will go very swiftly.

The ENTs that have performed Inspire 5 implant have responded very favorably, and we expect a pretty seamless transition moving forward.

Speaker 9

Thanks, Tim.

Speaker 7

Thank you.

Speaker 12

Thank you. I show our next question comes from the line of David Rescott from Baird. Please go ahead.

Speaker 9

Oh, great. Thanks for taking the question, Jim. Congrats on the start to the year here. I wanted to ask about OpEx so far and what's implied in the guide. If you look at the past couple of quarters, you've grown OpEx well below half of that of what the top line is. If you continue that for the rest of the year, you're getting somewhere ahead of what the EPS guide is for 2025 at this point. I'm just curious on what your assumptions are in the implied guide on EPS this year and whether or not we should be thinking about some incremental step-up or acceleration in spend behind the Inspire 5 launch. Thank you.

Speaker 7

Yeah. Thanks for the question. We're going to continue to invest in our operating expenses to drive top line. We continue to expect that revenue on an annual basis will outpace OpEx growth. We are going to continue to slightly increase our DTC on a year-over-year basis. We are going to spend more in patient marketing with the Inspire 5 launch, as Tim mentioned. R&D is going to continue to run at mid-teens. That does fluctuate a little bit. Stock-based compensation on an annual basis, too, is going to continue to increase. With that, that net-net is really going to get us to mid-single digits from an operating margin standpoint on an annual basis.

Speaker 12

Thank you. I show our next question comes from the line of Michael Cerconi from Jefferies. Please go ahead.

Speaker 13

Good afternoon. Thanks for taking my question. Just one on the Inspire 5 launch and CPT code 64568. It's been a few months of the limited market release now. I was wondering if you could just give us some commentary on how physicians are responding to the lower professional fee that comes with the 64568 code and if you're seeing any increased procedures in a day to offset that. Would love to hear what the experience has been so far. Thank you.

Speaker 7

Yeah. Absolutely. Thanks, Michael. I think we're going to track that very closely going forward. We have confidence in the reimbursement levels with 64568 and a $200 reduction with Medicare across the board. I think a lot of the limited live centers were academic, so they're not as effective. It equally balances the commercial centers with, as we talked about, general ENTs from a couple of questions earlier on, that they're comfortable with the procedure. I think a lot of excitement around Inspire 5 not putting in the pressure sensing lead will far outweigh the extra work it takes to do that part of the procedure. Not getting paid for the work that they don't do, I think, has been quite balanced so far.

The feedback from the physicians is very excited to not have to deal with the pressure sensing lead, with the reduced OR time, and just with the ability for them to plan their time consistently without having to implant that pressure sensing lead. We are going to continue to monitor this as we go through the year to make sure that the physicians are comfortable with 64568 and the reimbursement levels. The other key to it, though, is we are going to track their acceptance of Inspire 5. We really expect strong acceptance from the surgeons with the simplicity of the procedure compared to Inspire 4. Also remember, there is an increased payment to ambulatory surgical centers with the new code as well. I think the payers have all been very accepting going to 64568.

I think the surgeons will be accepting doing the more simpler procedure with the reduced time with the reimbursement level that's available. We'll continue to monitor that closely and continue to provide feedback throughout the year.

Speaker 13

Great. Thanks, Tim.

Speaker 7

Thank you.

Speaker 12

Thank you. I show our next question comes from the line of Shagun Singh from RBC. Please go ahead.

Speaker 15

Great. Thank you so much and congratulations. Just a couple of quick ones from me. What was the impact of pausing and inventory dynamics in Q1? On Q2, any color on EPS versus prior consensus at $0.41? I have a follow-up.

Speaker 7

Yeah. Thanks, Shagun. Regarding Q2, we talked about mid to high single-digit sequential revenue growth. With that, we are going to spend more in patient marketing with the Inspire 5 launch, but we do expect to be profitable in Q2 and then to improve that profitability sequentially throughout the year. Maybe a little bit lower in Q2, lower than current consensus, but we're going to grow that sequentially.

Speaker 15

You should also expect sequential EPS growth Q2 versus Q1. Got it. What was the impact of pausing and inventory dynamic in Q1?

Speaker 0

We didn't. I mean, it would have been really difficult to tell. There weren't really a lot of one-time items. As we said, the patient warehousing didn't manifest until later in Q1. It would be really difficult to quantify that. Nothing to call out.

Speaker 15

Got it. Just as a follow-up, I was wondering if you can comment on procedure profitability. It seems like we've gotten mixed feedback on that. I am just wondering, why do you not think that could be a barrier to broader adoption? Thank you for taking the questions.

Speaker 7

Yeah. Absolutely. Thank you. I think as we work with surgeons and work to help streamline their practices and how they introduce their Inspire systems, we can improve their profitability by streamlining their processes. We mentioned earlier that we have trained 100 APPs, advanced practice providers, that can really help streamline patient flow through centers in a much more efficient way for patients and for physicians to build their practices. This is pretty common across the higher volume centers where they can build efficiencies by having the surgeons spend more time in the operating room to do more procedures and with reduced OR time to be able to further build on the profitability. I think in the academic centers and some centers that do not do the same level of procedures, it is more difficult. Maybe that is where some of the feedback comes from.

In the high productive accounts, the ones that do the greatest number of implants, they understand throughput. They know how to leverage APPs. They have strong partnerships with sleep physicians to manage the patients longitudinally and have really built efficiencies into their practice to be profitable.

Speaker 12

Thank you.

Speaker 7

Thank you.

Speaker 12

I show our next question comes from the line of Chris Pasquale from Nephron Research. Please go ahead.

Speaker 2

Thanks. Tim, you talked about some early data on Inspire 5 being presented at some of the upcoming meetings. I'm curious what you expect that to show. Most of the focus has been on the increased convenience of this form factor. I think you've also said that you think the accelerometer could actually do a better job with respiratory gating. Do you expect that to manifest in any tangible outcome improvements?

Speaker 7

Yeah. I think that's kind of the key to it. Yes. Everybody's excited because they want to hear numbers about reduced OR time. The safety performance, what kind of have you seen any adverse events? Is all procedures completed successfully? The feedback has been very strong on all of those fronts. From a patient outcome standpoint, Chris, we always talk about how that's such a high priority for us. We believe the accelerometer does provide a more stable sensing environment. The data that we provided to the FDA as part of our approval process did show an improved stability. In Singapore, we actually did a little bit more of a detailed clinical study to capture that data and to capture the utilization or the patient adherence to therapy.

I'm not sure the AHI data will be available, but that is something we are also tracking, as well as we'll continue to track feedback from all the U.S. centers as part of the limited launch. Yes, when we're coming up on June, we will want to talk about outcomes more so beyond just what people always talk about with the reduced OR time. We'll talk about surgical times as well. To us, it really is a focus on those critical patient outcomes. We believe that with the improved sensing and we have new algorithms in the device, we think it can further improve our already strong patient outcomes.

Speaker 2

Great. Thanks.

Speaker 7

Thank you.

Speaker 12

Thank you. I show our next question comes from the line of Larry Biegelsen from Wells Fargo. Please go ahead.

Speaker 11

Hey, guys. Thanks for taking the question. Hey, Tim, just a multi-part question. When do you expect to complete the transition to Inspire 5? Last call, it was Q4. My question is, why won't these factors that you mentioned impact also Q3, given the full launch won't complete until Q4? Second, Tim, our checks also suggest that just linking the Inspire 5 CPT code to the ICD-10 code for sleep apnea can also slow things down. What are you seeing on that as well? Thank you.

Speaker 7

Gotcha. We talked last call that, yes, we would complete the transition by the end of the year when we stated that, of course, we did not have the full launch date announced at that time either. Now that we are doing the full launch date, we are going to do everything we can to really pull the individual centers forward. We do not expect to have too much carryover in the third quarter, as Rick mentioned, that we expect to have a stronger Q4 than normal. Again, we are reiterating full-year guidance. We are going to work hard. The field and the physicians are excited for Inspire 5. The contracting, as you recall, is quite simple because it is just a one-page or multi-page. It is a small contract amendment just to change from four to five. That should be pretty simplistic.

The new physician programmer, which was launched last year, most centers are ready to take on the new physician programmer. The transition should not be that difficult. We're going to work very hard in the second quarter. We'll track that as we get into Q3. Rick talked about the cadence for the second half of the year. As far as the linking to the ICD-9 diagnostic code, we're already working with CMS to get that done. As we mentioned before, we already have 80% of our 300 million covered lives. That does include Medicare. That does include commercial payers. It does include the VA. We have overcome that connection that you're talking about because we addressed that right up front.

Speaker 11

Thank you.

Speaker 7

Thank you.

Speaker 12

Thank you. I show our next question comes from the line of Anthony Petrone from Mizuho Financial Group. Please go ahead.

Speaker 2

Thanks. Congrats on the quarter here. Maybe just a question on capacity into the second half. Specifically, you mentioned, Tim, you are adding ENT, general surgeons. Obviously, we have a little bit of backlog that's pushed into the second half. Just wondering where that ENT capacity sits today, and is it enough to handle this bolus of volumes in the second half? The quick follow-up there would just be if you can give us any update on SleepSync and how that's evolving your front end of the funnel. Thanks.

Speaker 7

Absolutely. Thank you. Talking about capacity first, there are several elements that are in play there. Number one, the Inspire 5 device is a shorter procedure, allowing existing surgeons to do additional cases in any given day. Number two, we believe that once they start doing Inspire 5 and they are comfortable, that they no longer have to put in the pressure sensing lead. Again, remember, think of ENT putting a sensor into the chest wall. That will give additional confidence to schedule more cases as well, thereby increasing capacity. Two, we believe there are a number of ENT surgeons that just were reluctant to do the Inspire procedure solely because of that pressure sensing lead.

As we move through the year, we're going to be reaching out to those surgeons to make sure that they understand Inspire 5 is now available to be able to make this an important part of their practice going forward. Number three, we talked about our medical education and the significant number of new ENTs graduating and coming out and excited about including Inspire into their new practices as they go forward. Four, we're going to continue to add new centers as we work through the year, especially those centers coming on training directly into Inspire 5. It's really going to continue to be a strong focus to build this capacity because it continues to be the limiting factor for us.

From beginning of the call, one of the earlier questions talked about the number of patients still coming into the pipeline is overwhelming by the capacity that we have to serve these patients. Really going to be a key focus element to it. Your second part of your question is very strong. When we start talking about SleepSync, as we increase the number of patients treated, SleepSync provides an opportunity for the sleep physicians to manage a greater number of patients on a longitudinal basis. The majority of the high-volume centers already have SleepSync as part of their practice, and they can leverage that to streamline patient flow and how they manage their patients. What's key to Inspire 5 is Inspire 5, the new physician programmer, leverages SleepSync and logs into SleepSync to be able to provide data directly into that cloud-based patient management system.

Those centers that are on SleepSync have an easy transition in. As Rick mentioned on our R&D investments going forward, we're going to continue to invest heavily in our digital tools. A lot of that is all about SleepSync to really help the patient be part of their own care with the app, but really to also be able to help patient monitoring and help physicians be able to track how well their patients are doing with Inspire therapy. Pretty in-depth question, and hopefully, I got the right answers out to you there.

Speaker 11

All good. Thank you. Talk soon.

Speaker 7

Thank you.

Speaker 12

Thank you. I show our next question comes from the line of John Block from Stifel. Please go ahead.

Speaker 6

Great. Thanks, guys. Good afternoon. Maybe two-part. Of the 1,500 centers, Tim, what was the sort of incoming where delays were or are taking place? I'm just curious, was it a couple hundred centers that heard about five? Was it much more pervasive than that and across most of the centers? Any details would be appreciated. This is sort of a follow-up to a prior question, but I just want to make sure I've got it clear. The prior plan was to have, I think on the last call, all the centers trained by the end of 2025. I think you were citing full conversion by the end of 2025. Are you now talking about full conversion by, call it, end of QQ? If so, what gives you the confidence?

At the end of the day, that you're still able to put patient safety and patient priority first? Thanks.

Speaker 7

Got it. Thanks, John. I think from your first part of the question, it's more of a qualitative feel for patients delaying to get to Inspire 5 more than it is having specific quantities around that. Of the 1,500 centers, let's talk about the high-volume centers. If word gets out as the limited market release centers do cases and communicate that with their partners and with other centers and people become aware of it, yes, people listen to our earnings calls. They do read your note and the others' notes on Inspire 5 and the pending launch. I think that just continued to grow the awareness. Qualitatively, we're really starting to hear a little bit more about that across the board without putting specific numbers to it.

Going back to the previous question that you talked about in part two is, I mean, we're continuing to focus on the training of all the centers. This month, we're going to do the full launch to make Inspire 5 available. That's not committing that we're going to have every center trained by the second quarter. Certainly, we're going to focus on the high quartile centers first to make sure that they're up and running with five. We're going to make sure that we have full transition by the end of the year. Being that we're able to do the strong launch or the full launch right here in the May timeframe certainly gives us the opportunity to pull that full penetration up quite a bit. We'll keep tracking that, and we'll continue to report back to you on that.

Speaker 12

Thank you. I show our next question comes from the line of Brett Fishbin from KeyBanc Capital Markets. Please go ahead.

Speaker 3

Hey, good evening. Thanks for taking the questions. Just wanted to switch gears a little bit to the marketing strategy for Inspire 5. Sounds like you're going to be stepping up the DTC spend a little bit ahead of the launch, which makes sense. Really just curious how you're thinking about changing the external messaging to potential patients if you're going to be focusing on specifically some of the improvements to the procedure or if that's too in the weeds for general consumption. Maybe just a little bit more about how you're thinking about that. Thank you.

Speaker 7

Yeah, I think we'll do a little bit of both. We'll continue with our own outreach programs that's very strong and be able to get patients' awareness and to get them to the website. Our website will talk about Inspire 5, and we'll have to provide the necessary information to the patients so they understand the therapy going in. When they are able to make that appointment with their healthcare provider, they're coming in with knowledge of 5, coming in with confidence in the therapy and understanding of the process overall. We will be doing individual communications with patients who have come to our website in the past, left our contact information, and if there is new information coming out, to please let them know about the new information. We will go back and reach back to all the patients that have previously come to Inspire.

That is a significant number of patients that have visited Inspire over the years. Let them know that, yes, Inspire 5 is now available. It is in the full launch aspects of it. It is going to be a multiple-faceted marketing program to be able to get the word out even further.

Speaker 12

Thank you. I show our next question comes from the line of Michael Polark from Wolfe Research. Please go ahead.

Speaker 4

Afternoon. Thank you. Two quick ones. How many Inspire 5 implants to date worldwide? If you said it, I missed it. I'm just curious for the evidence base, the size of it ahead of launch. With all of the sequential phasing discussion, I'm interested if you're willing to put a finer point on 3Q. I hear the 2Q guidance. If I look at the last two years, 3Q has been up low single digits versus 2Q. 2Q sounds suppressed. Should we compare our 3Q to 1Q and do it that way? What kind of progression growth-wise would you expect? I'm really getting to how loaded the guide is into 4Q. Thank you.

Speaker 7

Sure. Let me tackle the first one, and we'll give Rick that second one. First one, we haven't really put out how many Inspire 5s we've done. We did early work prior to approval. We submitted that data to the FDA, and that's where we're able to collect devices or collect data with Inspire 4 patients and using external 5 to use those patients as their own comparisons. We have evidence going in that gave us confidence with the therapy. With the qualification data, we have significant evidence from that standpoint. Now, post-approval with a lot of commercial implants, both Singapore and through the limited release. We'll be pulling a lot of that information together, and you'll see some of that come out during the upcoming sleep meeting in Seattle in June.

Speaker 0

Yeah. Regarding the second half of the year, Mike, Q4 is historically our strongest quarter. I did talk a little bit earlier with my earlier responses that we expect even Q4 to be even stronger this year given the Q2 launch of Dynamics and how we expect utilization improvements to occur in the second half of the year.

Speaker 12

Thank you. I show our last question comes from the line of Mike Cratkey from Larynx Partners. Please go ahead.

Speaker 5

Hey, guys. This is Brett on from Mike. Thanks for taking the question, and congrats on a good quarter. The inventory days, obviously, we've spoken about this at length on this call, but it increased by almost a full quarter's worth of inventory. I just wanted to see how you're thinking about the progression of gross margin over the course of the year as this Inspire 5 mix increases.

Speaker 0

Yeah. We reiterated our gross margin guidance of 84-86%. We did increase that this year compared to a year ago. We have stated that without a price change, our gross margin is accretive with Inspire 5. We are going to continue to manufacture Inspire 4 throughout 2025 because we are going to continue to sell it internationally as we await approval. We want to make sure we have sufficient Inspire 4 inventory on hand until Inspire 5 is approved outside the U.S. Also keep in mind that a lot of the components for Inspire 4 can be used for Inspire 5 as well. We are going to continue to build sufficient inventory, and we are excited about the launch, and we are in a good spot for that this month.

Speaker 5

Understood. That's helpful. If I get one follow-up just on the OUS side, I don't know if we touched on it too much, but obviously, you said a tough comp, and it was down sequentially. Was there any FX that was impacting that?

Speaker 7

No real FX in the first quarter, but we are seeing some in the second quarter.

Speaker 5

Okay. Thanks, guys.

Speaker 12

Thank you. This concludes the Q&A session for the conference. I'd now like to turn the call back to Tim for any closing remarks.

Speaker 7

Thank you all for joining the call today. As always, I'm grateful to the growing team of dedicated Inspire employees for their enthusiasm, hard work, and continued motivation to achieve successful and consistent patient outcomes. The team's commitment to patients remains unmatched and is the most important element to our success. I wish to thank all of our employees as well as the healthcare teams for the continued efforts as we remain focused on further expanding our business in the U.S., Europe, and in Asia. For all of you on the call, we appreciate your continued interest and support of Inspire and look forward to providing you with further updates in the months ahead.

Speaker 12

This concludes today's conference call. You may now disconnect.