Inspire Medical Systems, Inc. Price & Performance (INSP)

Thank you, Dilemma, and thank you all for participating in today's call. Joining me are Tim Herbert, Chairman and Chief Executive Officer and Rick Diehl, Chief Financial Officer. Earlier today, we released financial results for the three and twelve months ended 12/31/2024. A copy of the press release is available on our Web 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 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 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 ks, 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, February 10, 2025. With that, it is my pleasure to turn the call over to Tim Herbert. [indiscernible] Thank you, Elgheed.

Thanks everyone for joining our business update call for the fourth quarter and full year 2024. 2024 was filled with many important milestones, including surpassing 90,000 patients treated with Inspire therapy exceeding three fifty peer reviewed publications the U. S. FDA approval of the Inspire V Neurostimulator, European Union, Meadow Medical Device Regulation approval, which included full body MRI compatibility, the approval of country wide reimbursement in France, and our [indiscernible] full year of profitability. We continue to strengthen our leadership team and recently announced an organizational change aimed at fueling our future growth. We welcome the new Chief Manufacturing and Quality Officer, Jason Kelly, who will lead our supply chain, quality assurance and regulatory teams. [indiscernible] Carlton Weatherby was promoted to the expanded role of Chief Strategy and Growth Officer and assumed leadership of the U. S. Sales and marketing team. Teams. Randy Bann transitioned to the newly created role of Executive Vice President of Patient Access and Therapy Development. A new team tasked with enhancing therapy outcomes and patient access. Increasing focus on research and clinical evidence development and leading our key opinion leader communications and medical society relationships. Randy will also continue to lead our [indiscernible] Organization is energized by these enhancements and we look forward to another year of strong execution in 2025.

Earlier in the year, we pre announced that we generated revenue of $239,700,000 representing a 25% increased compared to the fourth quarter of twenty twenty three. Given our strong performance we are reiterating our full year 2025 revenue guidance of $9.49 $55,000,000 representing 17% to 19% growth year over year. Net income for the fourth quarter was $35,200,000 compared to $14,800,000 in the prior year period represented diluted net income of $1.15 per share compared to $0.49 per share in the fourth quarter of twenty twenty three. With this, we are was our first full year of profitability with diluted net income of $1.75 per share compared to a loss of $0.72 in 2023. Further, we generated $130,000,000 in operating cash flow for the full year and we plan to improve profitability in 2025. As such, in 2025, we expect diluted net income to be in the range of $2.1 $2.2 per share.

As you know, in 2024, we received FDA approval for the Inspire five neurostimulation system. A key feature of the Inspire five device is that it incorporates respiratory sensing internal to the neurostimulator eliminating the need to implant the pressure sensing lead. This feature is designed to provide benefit to the patient with one fewer component to the physician with reduced surgical time and to the company with reduced production complexity and costs. Further, the Inspire five device provides the capability for future software based enhancements including sleep detection for auto activation, and sleep performance tracking. We have already gained valuable experience with the Inspire five device with systems implanted in both Singapore and in The U. S, and early feedback has been positive. We are continuing with our limited market release in The U. S. And we will continue to gain further experience with Inspire five procedures at additional U. S. Sites as we move towards full launch during the year. The primary factor driving the timing of our full launch remains building sufficient inventory to support the expected demand in The U. S. For the procedures performed in The U. S. To date, all cases utilize CPT code 64568.

And received prior authorization from the insurance carriers. CPT code 64568 was originally used by Inspire for the first eight years since our approval in 2014, [indiscernible] one neurostimulator and one StimulationLeadTheCurrentCPTCode64582 was only incorporated a few years ago and will continue to be used with all Inspire IV cases. We want to emphasize that the professional fee in CPT code 64568, a appropriately reflects the reduced work of implanting the The surgical placement of the sensing lead has long been a source of discomfort for ENT surgeons as it is not where they typically operate. We believe the result in reduction in surgical time associated with not placing the sensing leave will result in a comparable reimbursement rate for the surgeon on a time adjusted basis. Further, we believe the benefits of surgeon comfort and confidence with the Inspire five procedure will free up surgeon time to perform additional Inspire cases and will encourage more surgeons to adopt Inspire therapy. The new Inspire SleepSync programming system has been fully launched in The United States The goal for the new system is to provide more efficient patient programming and improved access to patient data to assist the healthcare provider in their decision making.

A key feature of this system is that healthcare providers may utilize their own laptop or tablet and simply log in to SleepThink to access programming screens. With this upgrade, Inspire is no longer required to provide laptops or tablets further reducing operational complexities. [indiscernible] With respect to our market development activities, we continue to advance our medical education programs And in 2024, we hosted over 300 advanced practice providers 300 ENT residents and 150 Sleep Fellows at Inspire training programs. The primary focus of our APP or advanced practice provider initiative is to improve capacity in both sleep and ENT clinics to meet the strong patient demand we continue to see for Inspire therapy. In 2025, we plan to increase the investments we are making in our medical education program including ongoing resident [indiscernible] and APP training continued participation in cardiology and primary care conferences, and initiating a continuing medical education program to support the awareness and adoption of Inspire therapy in cardiology, and primary care. We focus our patient marketing and education programs to deliver broad therapy awareness as well as provide a pathway for patients to connect with a healthcare provider that offers Inspire through our website and advisor care program.

In 2024, we designed our outreach programs to be more targeted And one example is with our digital advertising strategy, which has contributed to a significant increase in patient engagement at a lower cost. In 2025 and beyond, we plan to continue to invest in our robust marketing programs with the goal of further enhancing patient awareness of Inspire therapy and improving a patient's ability to connect with a healthcare provider. An exciting example to improve the patient experience is with digital scheduling. An online tool used by our advisor care program to directly submit electronic appointment requests to qualified healthcare providers on behalf of prospective patients. We currently have 300 centers using this tool and we plan to expand this program in 2025. On the market access front, we we continue to make progress updating our commercial payer policies to our expanded FDA labeling. Additionally, we facilitate patient access to Inspire therapy by assisting patients in obtaining prior authorization coverage decisions from payers. In this regard, we have steadily expanded our prior authorization team to enhance our ability to provide this assistance. I would like to provide one additional update. On January 17, we received a civil investigative demand from the Department of Justice.

The CID requests information relating to the marketing promotion and reimbursement practices associated with our products. We intend to fully cooperate with the investigation provide the information requested. [indiscernible] We are confident in the strength of our compliance programs and procedures and we remain committed to conducting our business ethically and in compliance with applicable laws and regulations. In summary, we remain focused on the patient to continue the growth and adoption of Inspire therapy. Inspire we will execute our growth strategy of driving higher quality patient flow and increasing the capacity of our provider partners to effectively treat and manage more patients. Our key strategies include 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 and our commercial teams objective to increase provider capacity. Looking ahead, 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 review of our financials. Thank you, Tim. Good afternoon, everyone. Total revenue for the quarter was $239,700,000 a 25% increase from the $192,500,000 generated in the fourth quarter of twenty twenty three.

US revenue in the quarter was $231,600,000 an increase of 22% the $189,400,000 in the prior year period. Revenue outside The U. S. Was $8,100,000 which was 163% increase year over year. In the fourth quarter, we added 72 new U. S. Centers bringing the total to fourteen thirty five active U. S. Centers.

As well as 12 new U. S. Sales territories bringing the total to two to three thirty five U. S. Sales territories. Gross margin in the quarter was 85%. Total operating expenses for the quarter were 171,800,000.0 an increase of 11% as compared to $155,200,000 in the fourth quarter of twenty twenty three. This plan increase was primarily due to the expansion of our sales organization increased general corporate costs partially offset by a reduction in R and D and patient marketing and education expenses year over year.

Interest and dividend compared to $5,900,000 in the prior year period. Operating income for the quarter totaled $31,900,000 compared to $9,300,000 in the prior year period. Net income for the quarter was 35,200,000.0 or a 15% net income margin compared to net income of 14,800,000.0 or 8% net income margin in the prior year period. This represented diluted net income per share of $1.15 compared to $0.49 in the fourth quarter of twenty twenty three. Adjusted EBITDA totaled $62,700,000 or a 26% adjusted EBITDA margin in the fourth quarter compared to adjusted EBITDA of $33,000,000 or a 17% adjusted EBITDA margin in the fourth quarter of twenty twenty three. The weighted average number of diluted shares outstanding in the quarter was $30,800,000 We are excited to announce that we generated $69,000,000 in op bringing the full year total to 130,000,000 and increasing our total cash and investment balances [indiscernible] For the full year 2024, revenue totaled $802,800,000 a 28% increase over $624,800,000.0 in 2023. U. S. Revenue was $771,000,000 a 27% increase year over year revenue outside The U. S. Totaled 31,800,000.0 a 71% year over year growth. Operating income totaled $36,100,000 for full year 2024, compared to an operating loss of $40,300,000 dollars in 2023.

Net income was $53,500,000 for full year 2024, a 7% net income margin compared to a net loss of $21,200,000 for full year 2023. A 3% net loss margin. Adjusted EBITDA totaled $157,800,000 for 2024, a 20% adjusted EBITDA margin compared to adjusted EBITDA of $44,900,000 dollars and a 7% adjusted EBITDA margin Full year diluted net income per share totaled 1.75 compared to a net loss of $0.72 per share in 2023. Moving on to 2025 guidance. We continue to expect full year revenue to be in the range of $940,000,000 to $955,000,000 representing an increase of 17% to 19% Compared to full year 2024 revenue, and we expect full year gross margin to be in the range of 84% to 86%. We expect diluted net income for the full year 2025 will be between $2.1 to $2.2 per share. As previously discussed, we will no longer guide to or report on centers. However, to give you a sense of how our commercial organization is scaling, we will continue to provide territories and field clinical representatives going forward. Although not formal guidance, we would like to provide additional color on 2025. Now that we have reached profitability, we expect our reported tax rate in 2025 to be roughly 10% primarily related to state and local taxes. [indiscernible] Excluding the impact of any share repurchases that we make complete over the remainder of 2025, we expect the full year diluted shares outstanding to be approximately $31,000,000 In conclusion, our strong performance and business momentum provide us with confidence in our outlook for 2025.

With that, our prepared remarks are concluded. [indiscernible] may now open the line for questions. Thank you, sir.

And if time permits, we'll be more than happy to take more questions. Please standby while we compile the Q and A roster. I show our first question comes from the line of Travis Steed from Bank of America Securities. Please go ahead. Hey, thanks for taking the question. I wanted to first ask about the EPS guidance I'm thinking of should we assume a linear path to profitability here assuming there's some conservatism kind of built into the the 2025 EPS guidance? And then also wanted to ask about the DOJ CID as well. Thanks a lot.

Sure. Hey, Travis. I'll take the first part of the question. On earnings per share guidance, we are committed to improving our annual operating margin on a year over year basis. And given our revenue seasonality that we've had traditionally, think to Q1. We do not expect to be profitable in the first quarter. But then we'll have sequential improvement thereafter on a quarterly basis throughout the year.

And on the DOJ CID? Absolutely.

We received that January 17. It's very new obviously active. There's only so much detail that we can provide, but we're committed to working with the inquiry and provide the information that's necessary. We're committed to our business ethically and in compliance with applicable laws and regulations and to working with our customers and other value partners continue to provide high quality medical devices We didn't add not anticipate that the investigation will interfere with the important work we're doing. To improve the lives of patients who need our products. So as noticed, the investigation remains ongoing as [indiscernible] Really don't have additional comments or details at this time.

Great. Understand. Thanks a lot. Thanks Travis. Thank you. And I show our next question comes from the line of Danielle Antalffy from UBS.

Hey, good afternoon guys. Thanks so much for taking the question. Tim, I wanted to follow-up on the commentary around the three centers that are doing the automated scheduling or online scheduling or however you characterize it, sorry if I mischaracterized [indiscernible] at those centers? Have you seen growth accelerate from a patient volume perspective? Or maybe the right way to ask the question is more streamlined process. Maybe talk a little bit about what you've seen at those centers, what kind of impact that's having on the ability to work through volume And one quick follow-up question on Inspire five Inspire reimbursement, your favorite topic.

No problem. Hi, Danielle.

You've let's take it back a little bit. You've been with us for a while tracking the story.

Did a pilot program a few years ago.

And what we want to do is measure the success of patient appointments using digital scheduling as compared to the normal pathway which would be through direct phone calls or via email between the center and the patient. We saw a significant advantage by using the digital scheduling, meaning the advisor program, advisor care program has direct linkage into the center to send the patient appointment request directly and it really streamlined that process. Therefore, '24, we started to ramp up the number of centers. That were participating in that program We ended the year at about 300 centers and it's a big initiative as we start this year to continue to take advantage of the technology to improve the patient's ability to make an appointment. So we're going to keep pushing that program based on the success of the pilot program we saw a couple of years ago.

Okay. That's helpful. And then just on I appreciate the commentary you provided thus far. I mean one of the things we talk about, I know you and I have spoken about this in the past is physicians reimbursement. And maybe you could talk a little bit about what you're hearing from your physicians and whether they're happy with reimbursement as it is or is that a barrier, I guess, I should ask to physicians doing the procedure if if the physician fee does come down a little bit? Thanks so much.

Absolutely. Thanks, Danielle. We don't believe it's going to be a barrier. In fact, we think it's the opposite. It's going to be opportunistic. I think the purpose of Inspire Inspire was to remove a key barrier that we had with ENT surgeons and that was the placement of the pressure set lead in the chest wall of the patient, which is just not where they operate every day. Therefore, with the accomplishment of five, it is reduced work, but it's it's the right kind of reduction of work that so that E and T's can focus on their strength, placing the electrodes, tunneling and placing the neurostimulator And that's the feedback that we saw with the cases in Singapore and the centers that we already have implanting patients in The United States to date.

The feedback is exactly that wow. We're not in planning the pressure testing lead anymore. And they're able to progress to the next case.

And with that, we believe there's going to be reduced surgical time and the reimbursement will be on a time adjusted rate will be consistent between Inspire four and Inspire five Inspire.

Allowing them to do more cases in the day and the reimbursement for ambulatory surgical centers is actually higher.

So for those surgeons who are have a stake in their ASC, there's a benefit to be able to bring more and inspire cases to to the ASC. So we don't think it's going to be a barrier. I think that there's talk early on, of course, about the rates. But once we move further into our limited launch and into full launch, We don't think this will be a barrier as physicians will quickly progress.

If I can add one more topic to this. What we talked about last year quite a bit with physician reimbursement or the professional fee, is making sure that the ENTs have efficiencies in their [indiscernible] That's what we talk about when we talk about APP's or Advanced Practice Providers, to ensure that the APP's are able to educate the patients in the office to be able to help streamline the patient flow or help them navigate through the practice. And the surgeon focuses on performing the surgical maximizing their time and really taking care of the reimbursement. We don't think it's going to be a barrier as we move into Inspire four Inspire Inspire five. As we progress into the year.

Gotcha. Thanks so much.

Thank you. Thank you.

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

Great. Thanks for taking [indiscernible] For Rick, considering that we are having going from a limited launch to a full launch, then [indiscernible] How do you want us to think about the phasing of revenues and expenses and margin as we go through the year. You talked about negative EPS in the first quarter, but how should we think about where how you want us maybe versus historicals and think the Street is in a good spot for first quarter to start the year? Thanks.

Yes. Thanks, Robbie. Yes, we normally don't don't discuss consensus, but given the Inspire five launch dynamics we did make some comments earlier this year about Q1. And generally, we are comfortable with Q1 estimates. But we do expect to see sequential improvement in revenue throughout the year. After we have our seasonality in the first quarter, And we're going to continue to make investments in our business and in R and D as well as continue with our expansion of our footprint we will continue adding sales territories and adding centers We're not going to be guiding to it, but generally, it will probably be in line with our historical trend. So we'll continue to increase expenses throughout the year. But with that, the increase of sequential growth in revenue, profitability will follow. Great. And maybe one, just on GLP-1s. I know it's painful to bring it up, but it just got added to one of the labels for sleep apnea. Wanted to see what, if anything, you're seeing in the field, the clinical discussions and just the latest on how you see Inspire fitting into the equation? Sure. Thanks, Robbie. We don't see GLP-one as a difficult subject.

We spent a lot of time talking about it. As you realize or just stated, just came on label and I think we're still trying to understand how it's going to be covered and really what the strategy is to be able to educate the sleep physicians and what the distribution plan is. That being said, we haven't seen the tailwind yet, but we believe it's coming. What's going to really help patients lose weight and reduce their lateral wall plaques to be able to qualify for Inspire. We continue to believe that this is a benefit for Inspire and for patients to help them lose weight who whereby they they wouldn't qualify for Inspire. We continue to work with our sites. We have several single sites that are conducting early work to try and measure. The success of helping patients lose weight and and qualify for Inspire. And we'll continue to monitor and report back. But I think it's pretty early on and again we haven't seen the tailwind yet.

Thank you very much. And I show our next question comes from the line of Chris Pasquale from Nifin Research. Please go ahead.

Yes, thanks.

Rick, you made great progress in 2024 on profit five guidance, know you said you're committed to improve margins for the year, but it doesn't seem like it's implying the same kind of leverage that we saw last year. So we think about the big buckets for spending, R and D was down in 2024. I think you said that DTC was going to kind of flatten out. Should we expect any of those to really ramp up here? Or what else has implied in the earnings guidance that you guys gave? Sure. With our guidance of $2.1 to $2.2 per share, Chris, we do expect revenue growth will continue to outpaced OpEx growth DTC, we're expecting that to be flat year over year, so roughly $94,000,000 R and D will probably run mid teens as a percentage of revenue. And so and we also mentioned the tax rate will be roughly 10% And so it does imply with our guidance that we will have low single digit [indiscernible] income margin. So there will be some improvement. But we are committed to improving our annual margin improvement and but we are going to continue to invest in long term growth.

We're very lowly penetrated in our potential market. As well as the number of surgeons as well as centers. So we're in this for the long term. And on a longer term basis, we still believe that we can still reach 30% operating margins. And with the Inspire five launch, when you do make that transition, is there any sort of near term impact on gross margin that we should think about? Is that initial inventory coming through going to be higher cost of production or is that not a factor?

No.

No factor. We did increase our year our annual gross margin guidance to 84% to 86%. And that so that does include a tailwind in the gross margin from Inspire five If there's any short term items, we don't see that at this time.

Great. Thank you. Chris, got to give you a shout out. Congratulations. [indiscernible] Thanks, Tim. Thank you. I show our next question comes from the line of Anthony Petrone from Mizuho Financial Group. Thanks. And I'll take in the congrats to Puskar there. It was a great game for the Eagles. [indiscernible] Maybe a couple on Inspire five, Tim, just when we think about year ended the year at a little bit over 1,400 centers, Can you share how many centers in The United States actually have Inspire five at this [indiscernible] and at what point do you expect that to be fully launched throughout all all sites in The United States. And the quick follow-up will just be on the sites that are doing it in The United States and Singapore. Can you share how many cases they are doing per day? Like what is the uptick in in daily cases at those early adopter sites? Absolutely. Thanks. I think the key is Singapore started earlier and we mentioned earlier in the year that they had done 40 of a plant. I think 46 and they've accomplished a couple more since then, but they're going to complete that group.

Then we did the first cases in [indiscernible] Since we've opened up just a couple of additional sites, with several additional plant in the next month and we'll keep ramping the limited market release as we move forward. Again, the limiting factor to our full launch is building up our product and that continues to be we're progressing there. So that's real positive. We're learning quite a bit as we continue to increase the number of centers during the limited market release. So we'll keep scaling up the LMR as through the year and when we have proper quantities to do the full launch, we will broadly launch the product.

Thank you. And I show our next question comes from the line of Richard Newitter from Truist Securities.

Please go ahead.

Hi, thanks for taking the question. I'll just try to squeeze two quick ones. And congrats on the profit this quarter. I guess the first I think you had spoken in the past about a back half versus first half waiting in part due to Inspire five Inspire.

Could you just reconcile that with the comment that you feel comfortable with 1Q and maybe just help us understand what the magnitude of that first half, second half might look like And then just second, in your 10 ks, you said that you you're looking to drive an increase in utilization at established centers or growth in center utilization. I guess, can you just talk about what exactly that means? I know you're not giving utilization growth guidance anymore, but just is there anything anything in that that you can parse out for us? Thanks.

Sure. Again, regarding guidance, we provide annual guidance. We don't like to speak too much on the quarterly breakdown, but we do expect our seasonality, we are comfortable with with Q1 where estimates are at and we expect to have sequential growth thereafter You can look back historically on what our sequential growth has been. We're not signing off on that, but we're really expecting to have continued increase in our sequential revenue as we have done in the past. From a revenue standpoint, There's still a lot of moving parts with the Inspire five launch and the the biggest one is making sure we have adequate inventory on hand. We're very excited. This is a our largest product launch in the history of the company. And so we're excited to the full launch Going. And then on your second question, in our guidance assumptions we are assuming the Inspire five launch.

In our guidance. But we're not really assuming much impact to our throughput. But what we didn't specify utilization, Rich, so much is but we did say that we're going to continue to expand our footprint of territories and centers and that's generally in line with what we've done historically. [indiscernible] we're no longer providing those metrics, but we will give you an update on sales reps and field clinical reps going forward.

Okay. But just to be clear, there's no there's no major difference on first half, second half seasonality versus prior years. In your current guidance? Because of Inspire five Inspire?

No. I mean, you've seen our historicals, they've it builds throughout the year, right, because we have seasonality. That resets in Q1 and then generally revenue builds throughout the year.

Okay. Thank you.

Our next question comes from the line of David Rascot from Baird. Please go ahead.

Great. Thanks for taking the questions and congrats on finishing the year here.

Two from us and maybe I'll ask both of them upfront. Obviously, you have the the comments on the cadence for the full year, brought parse out whether or not international and specific is something that should be accretive to the growth And then when you think about the pieces on the P and L for 2025, heard the comments on tax and spend, but just curious what your assumption is, maybe for income, which is a bigger component of the P and L? Thank you.

Sure. Thanks for your questions. Regarding OUS revenue, we still has trended for quite some time to be between 34% of our worldwide revenue. That will continue for the foreseeable future into 2025. [indiscernible] as quickly as The U. S. Is growing, it's hard to keep pace. Given It's between 34% of our worldwide revenue. We don't expect that to change in 2025. And then your other question Interest income was $20,000,000 for the year.

Could you catch that? $20,000,000 for the year, roughly $5,000,000 per quarter for interest income?

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

Hi, Tim and Rick. Congrats on the leverage in the quarter and thanks taking the questions. I wanted to start with one on Gen five. In our text, it's been pretty consistent. The fifth gen device should unlock faster and drive increased capacity. But I guess the question is, how do you help kind of ensure that the extra OR capacity is allocated to Inspire versus the other ENT procedures that the doc has on his or her plate and is there anything that you can do to kind of help the doc stack Inspire cases? And then I had a follow-up. Yes.

No, I think that's a really important item and we work with E and T to look at what are the other procedures that are demanding your time. And we did a search on our own with CPT codes of general ENT procedures to look on a per minute basis what competes with Inspire and in turn Inspire is at the higher end of the list for those procedures that our ENTs are performing. The key to it is building the efficiencies to it such that the ENTs, probably some of the ENTs that you talked about in your checks are the high volume implanters and they have support teams to be able to educate patients, help navigate patients, whereas the surgeons can spend a lot of their time in the Operating Room and if they have partners that can also participate in doing implants. And so we need to make sure that we build the efficiencies so they can do spend more time in the OR. And then the key is to set case dates and that's really the priority for us. This year too where when they come in the morning, they know this is an [indiscernible] And so it's not just for the surgeon, it's for everybody in the OR suite.

They know what procedures are happening. They know what equipment and what surgical trays to have in there. And everybody can perform at a high level. It's even down to the reimbursement. The reimbursement people know it's an Inspire date. So they know what codes to be able to use in that day for those cases. So it's about driving consistency and really starting to stack case days and show the benefit of Inspire with the reduced time, make sure the OR supervisor understands that such as they add another case without risk risking going into a second shift or an overtime, [indiscernible] On the other hand, they don't want the lights out in that OR suite either.

So it's all about building the efficiencies and we think Inspire five is really going to build confidence and the comfort for the ENTs to do so. That's really helpful color, Tim. Thanks for all that. And just one quick one on gross margin. For Rick. 84% to 86% for the full year is the guidance. Just wanted to kind of maybe flesh out some of the key assumptions there. And I guess specifically the impact from the Gen five launch, how much of a positive contributor is Gen five to gross margin this year? Or do we see more of kind of a pronounced impact benefit to gross margin in 2026? Thank you.

Sure. We did increase our guidance by 100 basis points at the midpoint. And we have assumed the Inspire five launch in our guidance. And we've I think we've captured it with the tailwind of Inspire five. 2026 would be a first full year of the impact more so in 2026 than in 2025 given that we're already into February.

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

Good afternoon. Thanks for taking the question. Tim, could you talk for a minute about just the logistics of transitioning back to the cranial nerve stimulation code How does that work for Medicare and commercial patients? And do you envision a period of time when centers do both Inspire IV and V? And I had one follow-up.

Sure. I think Three years ago, we transitioned from 64,568 to 64,582 And here we are by eliminating the pressure sensor, we're transitioning right back. And so we've done this and we've worked with the payers and a lot of them still have the six zero five, six zero eight still in their system. The key to it is making sure we update the software at the payers and CMS such that when the hospitals or the centers that ASCs build that code that it goes through. So we work with every pair to make sure that policies are updated and include both codes.

Including with CMS to have both codes because to your point as they worked on the Aspire four Inspire, there may be a short period of time where they are using both tows. There's no question about that.

And while we have several sites on the Inspire five limited launch now using 64568. Those centers are in fact also doing Inspire four cases. So it's a little bit of hand holding upfront, But again, as we mentioned, we expect a full launch through the year and transition by the end of year So most sites will all and the payers will all be transitioned over by then.

That's helpful. And Tim, what are you assuming in the guidance for competition and any potential warehousing of patients before the full launch of Inspire V. Thank you. Absolutely. I think competition, we it's been very quiet. We don't know anything there. And have to do that inquiry on your own. But we know that, if they get approval that there will be some experimenting with some of the academic centers. So we're prepared for that and we include that into our guide, no question about that. We also know that as we transition into five, there will be patients that will want to wait. We believe that to be quite limited now. But there are patients who are aware of five and that it's forthcoming. And that they are they may want to choose to wait, but we don't think we're seeing a lot of that yet. But as we continue to ramp up, we'll monitor that very closely. But again, we do kind of build that into our guidance well.

Thank you.

Thank you. And I show our next question comes from the line of Shengun Singh from RBC.

Great. Thank you so much. I guess just to follow-up on the DOJ investment next steps or potential timelines you can share and estimates around potential costs to be incurred? Do you have a third party looking into this? Just curious if you can share anything in addition to what you already have? Sure. We just received it on January 17. We're just still in the very early stages. We're committed to conducting our business ethically and compliance with applicable laws and regulations We'll work with all our customers and other value partners to continue to provide the Inspire products We do not anticipate that the investigation will interfere with the work that we do to improve the lives of our patients and Again, so early on, we just can't provide the details. But again, we have confidence in our policies and we'll continue to work closely with the investigation to provide the information that they need.

Got it. And then I was hoping you can touch a little bit on your guidance philosophy. You're obviously [indiscernible] 25% year over year growth, you're guiding to high teens. What are you assuming in terms of a step down besides loss large numbers, it seems it's just that. But then what factors can really help you deliver another year of 2025 growth It seems like the Inspire five launch you said it's going to be a bit of a phased commercial launch. So maybe help us think through how you thought about the guidance and what you factored in for Inspire Inspire Thank you. We build a detailed plan at the beginning of the year. We take into a account all the elements that you identified, Rick earlier had identified many of those elements as well as as far as the tailwinds and even some challenges we see to build a detailed model. It's early in the year. And so as we progress, we see we'll continue to open up new centers, but we expect the majority of our growth come from increased work at existing centers or same store sales. And we'll continue to scale our field team to be able to continue our growth and continue to invest in our growth going forward.

Rick talked about continuing our DTC program consistent with prior year and we're going to continue to invest in our R and D and again, very excited about launching Inspire five as we move into the year.

Thank you.

Thank you. And I show our next question comes from the line of Brett Fishman from KeyBanc. Please go ahead.

Hey, Tim and Rick. Thanks so much for taking the questions. Just one from me. I was hoping you could provide a bit more color on where you currently stand around the inventory build for Inspire five ahead of the full market launch It feels like this keeps coming up really as the primary driver of timing. And then maybe if you could just touch on if there was any like barriers with the production process that was preventing this from happening as fast as you ideally wanted Thank you.

Sure. We are opening up a brand new production line that I say we have opened a brand new production line. Those are units off that line have been implanted Singapore, did the first implants last year in The U. S. And additional sites here this year It is an active production line. We are building inventory and we are starting to scale that production line. So with every new line, as you continue to scale up, we continue to make sure that we find efficiencies and then we add to the capacity at that production line. So the team is there today and working hard to continue to produce product and We did not disrupt the Inspire production line which continues to manufacture product today Again, once we transition to The United States, we do not have approval in Europe to be able to do Inspire five. So INSPIRE four will be needed into the future. So we are building a brand new production line. It's just a normal process of going through the setup process it's fully qualified. It is active. And we are in the process of scaling right now.

Super helpful. And just really quick follow-up on that one. Is there a general target level of inventory either in dollars or maybe like weeks of cases that you're trying to get to?

Without specifically stating a number, really what we're preventing, we don't want to start stop. We will have Inspire four, but we once we transition to five, we want to go. And so we're going to keep on a limited launch as we build up that inventory. And increasing the number of centers as we scale up But once we go to a full launch, we want to make sure that we have inventory to go forward Again, we just do not want to start stop. And having to go back to four and then restart five. So we're going to be a little bit careful about that.

All right. Thank you. Thank you.

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

Thanks guys. Good afternoon.

Maybe just a follow-up on that last one. For Inspire five, I think I'm just trying to get a better feel for how back end weighted it is or how it ramps throughout the year? And Tim, is it fair to say, look, this is going to be less than 5% of the overall Seems like you're certainly targeting full conversion in 4Q. I mean, do we think about it surpassing 50% of vols in the third quarter. Maybe you could just talk about the cadence and how we get there over the April?

And then I'll ask a follow-up.

Yes. John, I think it generally are describing it correctly. As we start to to ramp it up. I think that we want to be transitioned by the end of the year. I think it's certainly safe to say we're less than 5% in the first quarter. And it just kind of grow through the year as we progress. So the way you describe it generally we're comfortable with that.

Okay.

Then just on the UnitedHealthcare coverage changes, I think I've got this right, just sort of reimplementing the dice the warning is a little awkward, but call it the implementation of the absence of complete blockage What do you think about those changes, Tim? Do you expect them to stick And was the re implementation of the Dice a little bit of a surprise, obviously, with Predictor seemingly you're hoping to go the other way? With these payers throughout 2025.

Thanks. Okay. Are you like referring to like United? Yes. I thought I mentioned United, but correct. Yes, United.

Yes, I think we're working with United. They've made too many changes over a period of time. So we need to have discussions with them. But I think the intent is [indiscernible] if there's a way to more efficiently work with patients to understand who can qualify for Inspire United Inspire of that. But we need to continue to communicate with that The physicians are doing a great job and documenting the study and preparing the manuscript. So that's getting close. To be able to be submitted. And we'll continue to work with the payers. But I don't think the intent is to really go back and forth. I think there's just more communication that has to happen to make sure we clarify that. But again, we're going to continue to work with other payers to not necessarily specify the need for Dice to make sure that's up to the physician to properly diagnose the patient, so they are qualified for Inspire by using what method is appropriate for that patient. Not could be a dice, could be just BMI, could be neck circumference, but make sure we have the flexibility built into the system So it's up to the physician to make that determination.

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

Good afternoon. Thank you. Just one for me bigger picture. I know center disclosure is going away in '25, although Rick, I did hear you say quarterly adds probably about in the zone of what we've seen in the last couple of years. So square there, it gets you at the end of 2025 to say 1,600 or 17 centers just curious before this disclosure goes away like you update us on your longer term view of what a potential center base might look like? What are you planning for over a three to five year horizon? What's the the latest math there? Thank you.

Yes. Thank you, Mike. I think we want to stay consistent keep growing. As we talked about with some of our organization, we have a group that's focused on a lot of our national contracts and ASCs and to be able to help transition when we get to five into some of those centers, because we believe we can get an increase in utilization at those sites as well as grow same store sales across the board. So we look at continually expanding. We're at the very early stages as you know with ASCs and even when we look at some of our national contracts, we're in very early stages of adoption. So we have a quite a long way to go and now we have a group specific to addressing those targets and helping those national accounts really be able to adopt Inspire and really take advantage of the Inspire five.

Thank you. And I show our next question comes from the line of Mike, Kratky from Leerink Partners. Please go ahead.

Hi, everyone. Thanks for taking our question. Sam, I'd Tim, I'd love to circle back on some of those comments on the ASCs. So So, A, to what extent does driving continued adoption among ASCs fit into your strategic priorities this year? And then can you just help us understand what kind of an impact that could have just based on the different economics in that setting?

Absolutely. I think one of the challenges we had was economics and ASCs and specifically with the adjusted economic down south. And it limits the ability of ASCs to be able to adopt the strong INSPIRE program. Going to the new CPT code 64568, it increases the reimbursement at ASC is approximately $1,100 and that takes some from a breakeven or a loss situation into a slightly positive in some of the [indiscernible] And that really is an impetus to allow some of the physicians to take more cases, Medicare cases to their ASC. They can already bring the commercial cases there But there's a group of private practice ENTs who do most their implants in their ASC and they're unable to really participate with Inspire today due to the economics. So I think this new coding change will certainly help them. And we're going to put a concentrated effort to be able to help these SCs really grow the adoption.

Understood.

Thanks very much.

Thanks, Mike. Thank you. And I show our last question in the queue comes from the line of Suraj Kalia from Oppenheimer and Co. Please go ahead. Hey, Tim. Rick, you hear me alright? Very good, Suraj. Perfect. Congrats on a strong end to the year. Tim, I appreciate your comments about not providing any more commentary on the DOJ investigation. It's still early. But maybe you can shed some color for us Let's say thirty thousand patients were implanted in FY 2024, how many of them would you say have not tried a CPAP at all.

I don't specifically know that, but I think very Great.

It's a pretty hard requirement that we have as well as the physicians have. As well as the payers including government payers related to DOJ like Medicare and Medicaid It's a pretty hard standard that everybody takes very seriously. Got it. Thank you.

Thanks Raj. Thank you. This concludes the Q and A session for the conference. I would now like to turn it back to Tim for any closing remarks.

Thanks, Dalam. 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 their continued efforts as we remain focused on further expanding our business in The U. S. [indiscernible] and Asia.

For all of you on the call, we appreciate your continued interest in support of Inspire Inspire. And look forward to providing you with further updates in the months ahead.

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