Inspire Medical Systems, Inc. (INSP)
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Earnings Call: Q4 2022

Feb 7, 2023

Operator

Good afternoon. My name is Josh, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Inspire Medical Systems Q4 and full year 2022 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. I'll now hand the call over to your first speaker, Ezgi Yagci, the vice president of investor relations at Inspire. You may begin the conference.

Ezgi Yagci
VP of Investor Relations, Inspire Medical Systems

Thank you, Josh. Thank you all for participating in today's call. Joining me are Tim Herbert, President and Chief Executive Officer, and Rick Buchholz, Chief Financial Officer. Earlier today, we released financial results for the three and 12 months ended December 31, 2022. 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, continued effects of the COVID-19 pandemic, full year 2023 financial and operational outlook and improvements in market access, are based upon our current estimates and various assumptions. 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 annual report on Form 10-K, to be filed with the SEC by February 14th 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 7th, 2023. With that, it is my pleasure to turn the call over to Tim Herbert. Tim.

Tim Herbert
President and CEO, Inspire Medical Systems

Thank you, Ezgi. Thanks, everyone, for joining our business update call for the Q4 and full year 2022. We are excited to report our first profitable quarter and a solid finish to a very strong year, with significant progress across all elements of our business. As always, we first and foremost reiterate our commitment to patient outcomes and to ensure that each patient has the best possible experience with Inspire therapy. During today's call, we will highlight many accomplishments from 2022 that demonstrate our ongoing focus on the patients, including improvements in access to therapy, technology advancements, and planned activities to broaden the population that can benefit from Inspire. We will also discuss our outlook for full year 2023. We completed many important milestones in 2022. There are now over 36,000 patients who have received Inspire therapy.

During the year, we received FDA approval of full-body MRI compatibility and launched our silicone-based stimulation and sensing leads, along with the Bluetooth-enabled patient remote. We made significant progress with our digital platform, including major updates to the Inspire SleepSync patient management system and the Inspire Sleep app. We also initiated a pilot of a digital scheduling tool, which we believe will significantly enhance patient access to care through our Advisor Care Program. We submitted important indication expansions to the FDA, including for the pediatric population with Down syndrome and for patients with a high apnea-hypopnea index. We raised over $240 million in cash, as noted previously, and in the Q4 we achieved profitability for the first time, all of which gives us confidence as we enter 2023. Let's review our results.

In the Q4 , we generated revenue of $137.9 million, representing a 76% increase compared to the Q4 of 2021. For the full year of 2022, revenue totaled $407.9 million, a 75% increase compared to full year 2021. Our growth continues to be driven by higher utilization at existing centers and supported by the activation of new centers. During the Q4 , we experienced challenges with our supply chain as the demand for the silicone-based sensing and stimulation leads outpaced our ability to provide product due to issues with scaling the production lines. These challenges have been resolved, and we are increasing our inventory levels. Despite these challenges, we were successful in providing product for all scheduled procedures in the Q4 .

Historically, we have experienced seasonality in the Q1 due to the reset of high-deductible health plans at the start of the year. While this remains the case, the Q1 of 2023 may see slightly less seasonality due to the supply chain issues in the Q4 . we expect full year revenue to be in the range of $560 million-$570 million, a 37%-40% increase compared to 2022. In the Q4 , we continued to increase our capacity by adding 61 new implant centers, ending the year with a total of 905 centers. At the end of the Q4 , ambulatory surgical centers made up 23% of U.S. centers. In 2023, we expect to continue to activate 52-56 centers per quarter.

Regarding the U.S. sales team, we created 16 new sales territories in the Q4 , bringing our total to 225 territories. We are increasing our guidance in 2023 and expect to add 12-14 sales territories per quarter compared to 10-12 per quarter in 2022. In 2023, we will continue to scale our sales management and training teams to optimize our ongoing expansion and to focus on strong patient outcomes and center productivity. We modified our incentive compensation for the field organization to focus on higher utilization at existing centers. We will continue to enhance our ability to connect interested patients with a qualified healthcare provider. Our outreach programs are very effective in generating interest in Inspire therapy, primarily through the inspiresleep.com website.

For the full year of 2022, the number of visitors to our website surpassed 13 million, an increase of 86% year-over-year. From these visits, we had over 78,000 physician contacts. Of note, these physician contacts represent the calls and emails to Advisor Care Program or directly to a physician's office and do not include referrals directly from a patient's healthcare provider. From a U.S. reimbursement perspective, the final rules for 2023 were published in November and came in generally as expected, providing a stable reimbursement outlook for healthcare providers. Moving on, our international business continues to make strides, growing 28% in the Q4 over the prior year, despite ongoing headwinds from unfavorable exchange rates. During the quarter, international revenue was less than 3% of global revenue, highlighting the significant growth in the U.S. market.

There were many positives in our international business during the Q4 , including the strong performance in Germany, the Netherlands, and Switzerland. Following many years of working with the French authorities, we are in the final process to have Inspire listed on the French registry in early 2023 at reimbursement rates consistent with the rest of the world, and the team continues preparations for a commercial launch there. In Singapore, our flagship programs continue to perform at productivity levels consistent with U.S. centers. We also see momentum in Japan, with multiple centers doing first procedures in the Q4 that have also completed or booked additional cases in the Q1 . In Hong Kong, we expect to complete our first procedures in February, and in Australia, we have resubmitted for reimbursement and should have a determination later this year. Turning to R&D.

We recently submitted our SleepSync physician programmer for FDA review. This new programmer connects with our next-generation SleepSync digital health platform, which is a key step toward providing remote patient programming. Longer term, we continue to work on the design of our fifth-generation Inspire neurostimulator. The Inspire 5 device will eliminate the pressure sensing need and incorporate the sensor inside the neurostimulator using an accelerometer to measure respiration. We have finalized the design and we are conducting operational and production qualification. We are still targeting FDA approval in late 2023, but depending upon the FDA review cycle, this could move into early 2024. Finally, we continue to conduct research and clinical trials to increase the number of patients who can benefit from Inspire therapy.

In the Q4 , we finished enrolling the first 300 patients in our PREDICTOR study, which is the first step to replacing the requirement for drug-induced sleep endoscopy procedure with an office-based measurement for patients with a BMI less than 32 and continue our plans for initial readout of the data in 2023. In summary, we are experiencing significant momentum in all aspects of our business. We remain focused on patient outcomes and physician education to continue the adoption of our therapy. In 2023 and beyond, we will continue to increase utilization at our existing centers while adding capacity by opening and training new centers. The ongoing expansion of our call center and investment in our DTC campaign support these initiatives, and we are seeing enhanced productivity from these efforts, which is driving our improved financial performance.

Finally, the many R&D achievements in 2022 highlight our commitment to improving patient outcomes and enhancing both the patients' and healthcare providers' experience with Inspire therapy. We remain extremely excited about our future prospects and are confidence 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.

Rick Buchholz
CFO, Inspire Medical Systems

Thank you, Tim. Good afternoon, everyone. Total revenue for the Q4 was $137.9 million, a 76% increase from the $78.4 million generated in the Q4 of 2021. U.S. revenue in the Q4 was $134.3 million, an increase of 78% from the $75.6 million in the prior year period. The growth in the U.S. reflects several factors, including higher utilization at existing centers, the addition of new implanting centers, expanded direct-to-consumer marketing, and a higher number of territory managers. Revenue outside the U.S. increased to $3.6 million, which is a 28% increase year-over-year on a reported basis, while units sold outside the U.S. grew 43% year-over-year.

The U.S. average selling price in the Q4 was $24,900 compared to $23,900 in the prior-year period. The increase reflects our price uplift that began in May of 2022. We expect U.S. ASP to remain steady at the current level. The ASP outside the U.S. was $20,400 during the quarter, compared to $22,700 in the Q4 of 2021, which was driven by unfavorable exchange rates and a lower ASP for distributor sales in Asia. Gross margin in the Q4 was 83.9% compared to 85.8% in the prior-year period, primarily due to higher costs of certain component parts and additional costs associated with the transition to our new silicone-based leads, partially offset by the price increase that began in the Q2 .

Total operating expenses for the Q4 were $116.1 million, an increase of 68% as compared to $69.1 million in the Q4 of 2021. This planned increase was due to expansion of our sales organization, increased direct-to-consumer marketing programs, continued product development efforts, and general corporate costs. The increase in operating expenses is reflective of our ongoing plan to drive continued long-term growth and to make investments in key areas of our business. Interest and dividend income totaled $3.4 million in the Q4 compared to $15,000 in the prior year period. This higher income was driven by higher interest rates on our increased cash balances. We had no interest expense in the Q4 , having paid off our outstanding debt in the Q3 of 2022.

We are proud to announce our first profitable quarter in the history of Inspire. Net income for the Q4 was $3.2 million, compared to a $2.4 million net loss in the prior year period. The diluted net income per share for the Q4 was $0.10, compared to the net loss per share of $0.09 in the Q4 of 2021. The weighted average number of diluted shares outstanding for the Q4 was 28.9 million. We expect Q1 weighted average shares outstanding to be approximately 29.1 million. During the Q4 , we generated $24 million in cash. We ended the year with cash and investments totaling $451 million.

The strong cash position allows us to remain focused on executing our growth strategy of increasing procedure volumes at existing centers while training and opening new implanting centers. For the full year 2022, revenue totaled $407.9 million, or a 75% increase over $233.4 million. US revenue was $394.8 million or 79% year-over-year growth, while revenue outside the US totaled $13 million, a 5% year-over-year growth despite foreign currency headwinds. Net loss for the full year 2022 totaled $44.9 million, compared to $42 million in 2021, with the net loss per share of $1.60 for 2022 compared to $1.54 in the prior year. Moving on to 2023 guidance.

We expect full year revenue to be in the range of $560 million-$570 million, a 37%-40% increase compared to 2022. Full year growth margin is expected to be in the range of 83%-85%. As Tim previously noted, we expect to activate 52-56 new centers per quarter and establish 12-14 new sales territories per quarter in 2023. Given the prevalence of high deductible health plans, we have historically seen seasonality in our business.

As Tim previously mentioned, we continue to expect revenue to step down sequentially in the Q1 of 2023 and will then increase throughout the year. In conclusion, our strong performance and business momentum provide us with confidence in our outlook as we enter 2023. Josh, you may now open the line for questions.

Operator

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please limit yourself to one question and one follow-up. Our first question comes from Travis Steed with Bank of America. You may proceed.

Travis Steed
Managing Director and Equity Research of Medical Technology, Bank of America

Hey, congrats on the profitability this quarter. I think in the past, you said once you turn profitable you wanted to stay profitable. I don't know if this is the start of that, 'cause I'm looking at The Street has over $2 in loss for earnings next year. Should that be closer to flat to slightly positive?

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah. Let me comment. Hi, Travis. Let me comment, first, then, Rick kinda jump in. I think as we know, we wanted to get to profitability. We know how important it is from a business standpoint. I think, moving forward, it will continue to be a desire of the organization, but we also know that in Q1, we do see seasonality there. Let me hand off to Rick there.

Rick Buchholz
CFO, Inspire Medical Systems

We did demonstrate some improved leverage in Q4, and we also expect in Q1 that we would lose some leverage just due to our normal revenue seasonality. We do intend to show improving operating leverage as we progress throughout the year. We're not changing our tone on profitability. We're gonna continue to run our playbook. It is important to understand that we do have a very disciplined approach in determining our spending and our investments across our business.

Travis Steed
Managing Director and Equity Research of Medical Technology, Bank of America

Okay.

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah.

Travis Steed
Managing Director and Equity Research of Medical Technology, Bank of America

Good color. For OpEx, something maybe in the 30% range, is that a good starting point? I'm curious if you would hold that if revenues come in higher than expected for the year, or if you would also kind of grow OpEx upside with revenue upside over the course of the year. The other follow-up was on the comment on Inspire 5. You just mentioned, I think, move into early 2024. I don't know if there was a change or something that drove that comment, or if it was just more of a caveat.

Rick Buchholz
CFO, Inspire Medical Systems

I'll start, Travis. As we, you know, we did demonstrate that the revenue did outpace operating expenses in the Q4 . We're not gonna guide on bottom line, which means also operating expenses at this time. We're gonna continue to make, you know, thoughtful, disciplined investments, but we're really focused on driving that top line.

Tim Herbert
President and CEO, Inspire Medical Systems

As far as the Inspire 5, I think we continue with the program. The design is frozen. We are going through the operational testing. We're building up the qual units, and we're building redundancies. We have multiple manufacturers for that product, again, to protect for supply chain. Always a little bit of a challenge to work the schedule to get all the testing done and get the submission in, but we're still gonna be pushing really hard to get the approval by the end of 2023, but we can see it slide into early 2024 if the cycle is tight.

Travis Steed
Managing Director and Equity Research of Medical Technology, Bank of America

Okay. That's fair. Thanks for the questions.

Tim Herbert
President and CEO, Inspire Medical Systems

Thank you, Travis.

Operator

Thank you. Our next question comes from Robbie Marcus with JP Morgan. You may proceed.

Robbie Marcus
Senior Analyst of Medical Devices, JPMorgan

Yeah. Thanks for taking the questions, and congrats on a really nice quarter.

Tim Herbert
President and CEO, Inspire Medical Systems

Hey, Robbie.

Robbie Marcus
Senior Analyst of Medical Devices, JPMorgan

Hey. Maybe starting with the guide. You know, you're coming off a really good growth year. Your guidance, in terms of growth is still a really healthy rate for 2023, but a pretty significant decline in growth rate versus 2022. By my math, it kinda looks like center utilization might be flat to down in the implied guide for 23. Anything other than your usual conservatism here, that we should be thinking about, implied in the guidance as we start the year?

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah, we wanna be very consistent on how we put our guidance out there, how we look at the business at the beginning of the year. We already mentioned in the note that we wanna continue to drive utilization to actually improve utilization at existing centers, in fact, to the point of putting additional incentives in there for the sales team. Again, yes, we wanna be careful putting guide out early on. We like to position as the company's in and really have been strong across the board with all of our milestones.

Robbie Marcus
Senior Analyst of Medical Devices, JPMorgan

Got it. While not a huge part of sales today, the international constant currency growth number in Q4 was really impressive, and a big step up from Q3 , it looked like. How should we think about the cadence of international throughout 2023? You know, can this be starting to become a material contributor? Thanks.

Tim Herbert
President and CEO, Inspire Medical Systems

Thank you very much, Robbie. I think we're very excited about international and we know it's just days away before getting confirmation from the French authorities that we will be listed on the registry as an accepted product, fully reimbursed in France. We're recruiting a country manager there. We think France is gonna have a good year. We think Belgium will follow that, as well as the Netherlands is set up to have a strong year in 2023. Germany, on top of that, even the UK has started doing cases too. We like what's happening in Europe. On the other side, Singapore, Hong Kong will be doing the first case in just a few weeks, Japan has really started to uptick a little bit.

I think it's gonna be a measured success, with the growth in international, but the key thing is still hovering around the 3% mark as far as global revenue. We're not gonna take our foot off the pedal on the United States. We wanna continue to grow utilization and really focus on the US market as well. While I think you'll see continued growth internationally, our emphasis continues to be on the US market.

Robbie Marcus
Senior Analyst of Medical Devices, JPMorgan

Really helpful. Thanks a lot.

Tim Herbert
President and CEO, Inspire Medical Systems

Thanks, Robbie.

Operator

Thank you. Our next question comes from Adam Maeder with Piper Sandler. You may proceed.

Adam Maeder
Senior Research Analyst, Piper Sandler

Hi, Tim. Hi, Rick. Hope you can hear me okay. Congratulations on the nice finish to the year. Maybe just to start, wanted to ask about direct-to-consumer expense. Realize there's no guidance on OpEx. Just remind us kinda where 2022 DTC spend came in and how investors should think about spend in 2023. Then just longer term kind of, you know, direction where this could go.

Rick Buchholz
CFO, Inspire Medical Systems

Hey, Adam, it's Rick. We continue to make investments in DTC because it's very important for our pipeline. We talked about over 13 million visits to our website and 78,000 physician contacts. It's a very important part of our business. In the Q4 , our DTC spend was about $21 million. That's relatively flat over the Q3 , we're gonna continue to increase that. Year-over-year, in 2022 we spent $74 million, that was up about 55% over 2021, where we spent $48 million. We're gonna continue to make those investments and grow our investments in DTC, that growth will slow. It'll be less than 55%, we're not giving specific guidance around what might be right now.

Adam Maeder
Senior Research Analyst, Piper Sandler

Okay. Understood. Thanks for the color there. Just for the follow-up, you guys give helpful color and guidance on new account adds. I'm curious if you are able to share some color on implanting physicians per account. You know, are there metrics you can share there, and how do you think about those trends going forward? There's clearly a lot of demand for your product, so wondering how you think about the importance of not just growing the account base, but also the number of docs at existing centers. Thanks for taking the question.

Tim Herbert
President and CEO, Inspire Medical Systems

Absolutely, Adam. Great to hear from you. Thank you. It continues to be a focus, and it's one of the fastest ways to be able to increase capacity at an existing center is to add a surgeon. We'll continue with a focus on it. We don't have specific metrics here, but it is one of the key methods to work with centers to either grab additional OR time for the existing surgeons, but to also just train their partners to be able to have additional OR time because we know the demand certainly is there. We'll continue to look forward and try to provide some more specifics on that, but it is certainly a key factor in for our field team to be able to grow capacity.

Adam Maeder
Senior Research Analyst, Piper Sandler

Thank you.

Tim Herbert
President and CEO, Inspire Medical Systems

Thank you, Adam.

Operator

Thank you. Our next question comes from Rich Newitter with Truist. You may proceed.

Rich Newitter
Managing Director and MedTech Equity Research Analyst., Truist Securities

Hi. Thanks for taking the questions, and congrats on another really great quarter, solid finish to the year.

Tim Herbert
President and CEO, Inspire Medical Systems

Thanks.

Rich Newitter
Managing Director and MedTech Equity Research Analyst., Truist Securities

wanted to maybe just, start off on the one two seasonality comments in the context of the, kind of the 4Q impact you called out on supply issues and maybe some deferral into the 1Q. You know, typically you see, I think, you know, last few years, about a 10%, or, or, you know, low teens % decline 4Q to 1Q. It sounds like you're suggesting that might be a little bit less than normal. Is that correct, at the 10%, you know, or less of a sequential decline or less than historical is a good way to think about it? And could you quantify what you think that supply push out, procedure, you know, demand push out might have, might have been?

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah. Yeah. Let's go back and talk a little bit about what we're talking about first. First, I think Rick was hitting, we've always kinda talked about like a 12% seasonality as we moved into Q1. When we're talking about with these stimulation leads, Remember we're in the Q3 when we transitioned from the polyurethane production line to the silicone production line, we built up a safety stock polyurethane, then we had to stop and purge the line and get them back up and running. We did that, but we have to be able to get up to volume, and then the process of scaling is when we ran into some of the challenges. We went to more of a just-in-time delivery to support cases and would be holding some powers, part level orders or things like that.

We were able to fulfill and closely track with scheduled procedures to make sure that we had all those products ready to go. For cases that get scheduled in January and part of the just-in-time system, some of those may ship in January. Probably not a big number, but certainly wanted to bring awareness to that in that the seasonality still exists, but with the supply chain challenges, it might offset that a little bit. Just to make everybody aware of that. The good news is the inventories are growing and the production lines are scaling up.

Rich Newitter
Managing Director and MedTech Equity Research Analyst., Truist Securities

Okay, that's helpful. Got it. It sounds pretty minor. You know, your normal seasonality is probably a good way to think about it.

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah.

Rich Newitter
Managing Director and MedTech Equity Research Analyst., Truist Securities

Then just on the account opportunity, you know, I think, I think you're right under 1,000, you know, centers right now in planting centers. You've talked in the past about, you know, I know it's very high level, but I think something to the tune order of magnitude of 4,000 accounts in the U.S. that you could theoretically get, and I think you've also said there's 4,000 ASCs out there. Can you maybe just refresh our memory on kind of how you see that 1,000 installed base, you know, progressing towards some account opportunity? What is the right account opportunity?

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah, good question. When we took that 4,000 and 4,000, got to a total of 8,000, we just assumed about a third of those centers would have a capability or would be doing Inspire, and that put our target market at 2,400. Over the last couple of quarters, we've been spending more time evaluating that. We've been recognizing in smaller communities, physicians are setting up centers that don't require patients to take long drives into more of the larger city centers. We're gonna continue to evaluate that. I think the number of centers that we can move to will far exceed the 2,400.

We've already demonstrated in some towns in Idaho, Montana, even in that well, Jackson, Wyoming, that there are very productive accounts in these smaller communities, and we can really leverage the community doctors to be able to offer Inspire and have more community-based care. I think that story continues to evolve, and we will continue to increase the number of centers capable of treating patients with Inspire.

Rich Newitter
Managing Director and MedTech Equity Research Analyst., Truist Securities

Thank you very much.

Tim Herbert
President and CEO, Inspire Medical Systems

Thanks, Rich.

Operator

Thank you. Our next question comes from Larry Biegelsen with Wells Fargo. You may proceed.

Larry Biegelsen
Managing Director and Senior Medical Device Equity Research Analyst, Wells Fargo Securities

Good afternoon. Thanks for taking the question. Hey, Tim and Rick and Ezgi. I wanted to ask on the guidance and the new indications and label changes. Tim, what are you assuming for the timing, you know, down to AHI, BMI, and any impact that you're assuming in the guidance?

Tim Herbert
President and CEO, Inspire Medical Systems

Got it. I think the, we're very optimistic with the pediatric population with Down syndrome. I think that, we've been working closely with the FDA to answer questions that they have. They've come and done audit on the clinical data, so we know that they're progressing in their review as well. We're optimistic that that should happen in the first half of the year, which I think is really exciting. As far as the high AHI and the warning for BMI, I think that also is progressing. We're working with the FDA again and a little bit earlier stage, so that'll take a little bit longer to be able to get that approval, but certainly confident that that's coming through, and it does have the proper designation to help accelerate the review at the FDA.

We expect both of those in the near future and should have a impact on the business. We did try to kind of build that into the guide that we put forward. I think in both of those populations, it'll be a little bit of a slow uptick as we get awareness out there and to be able to incorporate that into the existing practices. The good news is, a lot of the pediatric hospitals or the children's hospitals are affiliated with some of the larger institutions that already do Inspire today. We already have an Inspire presence. Hopefully that will streamline our ability to get those centers up and running on the pediatric front. More to come on that. We're very excited about that population.

It's near and dear to our heart, and we're working with the societies and the, and the parent, the family groups to be able to build awareness of that.

Larry Biegelsen
Managing Director and Senior Medical Device Equity Research Analyst, Wells Fargo Securities

Tim, just one follow-up on pediatric Down's. Why do you think the uptake will be low there? They're relatively well, you know, well organized community, if you will. You know, I think the clinical need seems pretty high here. You know, you've been working on this for a while. Why do you expect the, you know, uptake in that population to be slow? Thanks for taking the questions.

Tim Herbert
President and CEO, Inspire Medical Systems

Thank you, Larry. I think the we've been working on it for years, and you've seen the clinical studies and the enrollment of those studies, and it's still a relatively small number of patients have received Inspire in that pediatric group. I think it's just a, it's a new therapy and a new option for the families and the doctors to be able to understand. I think this is gonna be an educational process like any new indication or like any new therapy or in introducing Inspire into any new country. There's just always just a little bit of a slow adoption curve as people learn about the therapy and become comfortable with it and increase the prescription of the therapy.

Larry Biegelsen
Managing Director and Senior Medical Device Equity Research Analyst, Wells Fargo Securities

All right, fair enough. Thanks a lot.

Tim Herbert
President and CEO, Inspire Medical Systems

Thanks, Larry.

Operator

Thank you. Our next question comes from Jon Block with Stifel. You may proceed.

Jon Block
Managing Director of Healthcare Equity Research, Stifel

Thanks, guys. Good evening. Rick, maybe first one for you. Given the EBITDA number for the quarter, I'm calcing around $15 million. I just don't have the cash flow statement. Maybe just your thoughts on around $15 million. If so, you know, I believe you guys would be EBITDA positive for full year 2022. Maybe just provide your thoughts on how that would look or trend for full year 2023.

Rick Buchholz
CFO, Inspire Medical Systems

Yeah. Stock-based compensation was about $15 million. In rough terms, Jon, we're about $18 million roughly in EBITDA positive for the Q4 . Yeah, that stock-based compensation expense has increased. Again, that will increase. We're also gonna continue to make investments along our all facets of our business R&D, sales and marketing, and so on. With that, we expect that, you know, we'll lose leverage in the Q1 with our seasonality, but then gain that back as we progress throughout the year. Again, we're not providing any guidance on OpEx or bottom line at this time.

Jon Block
Managing Director of Healthcare Equity Research, Stifel

Yep. I got it. I guess maybe just as a follow-up to that, you know, if you were EBITDA positive for full year 2022, which you just confirmed, and you expect leverage, not for 1Q, but over the course of 2023, we can just sort of draw our own conclusions from there. Is that a fair statement?

Tim Herbert
President and CEO, Inspire Medical Systems

That's fair.

Jon Block
Managing Director of Healthcare Equity Research, Stifel

Okay. Perfect. Then can you just talk to us, if you don't mind, on the ASCs a little bit? I think it came in again, 23%. Is that representative as a % of the overall procedures? Maybe more importantly, how do you see this playing out, you know, and evolving over time? I think initially you were excited about, you know, those potentially being higher utilization settings, the reimbursements improved there. You've got a good number or percentage of commercial payers. Could you talk to us on how that can help, you know, act as an overall driver for utilization for Inspire longer term? Thanks.

Tim Herbert
President and CEO, Inspire Medical Systems

I think we continue to be excited about it. I think this may be a little bit more of a post-COVID-19 phenomena where the hospitals are really active again. While we're still at 23%, we're still growing the number of ASCs, but we're growing the number of hospitals as well, and that's not too surprising. I do think the utilization impact that we're seeing is part of a factor of the ASCs. I think right now we're running maybe 20% of our procedures are done in ASCs, even though ASCs make up 23% of the centers. What that means is they're taking more of their fair share of the procedures. That's really good to see the utilization growing in both centers, but particularly in ASCs.

As we continue to progress, I think we'll continue to look for further sites of service. As we know, the reimbursement in hospitals continues to be very, very strong, and our ability to garner OR time to take care of the patients continues to grow, and that is evidenced by the increased utilization across the board. We're not taking our focus off ASCs, but we continue to leverage all the hospitals that wanna participate with Inspire as well.

Jon Block
Managing Director of Healthcare Equity Research, Stifel

Got it. Thanks, guys.

Tim Herbert
President and CEO, Inspire Medical Systems

Thanks, Jon.

Operator

Thank you. Our next question comes from Mike Polark with Wolfe Research. You may proceed.

Mike Polark
Director of Medical Supply and Devices Analyst, Wolfe Research

Hey, good evening. Thank you for taking the question. First topic, the comments on modifying incentive compensation for your field force to focus on higher utilization at existing centers. I guess, can you level set, is this a notable change? Is it a subtle change? What did the framework look like before? What does it look like now? I guess why make this change for 2023?

Tim Herbert
President and CEO, Inspire Medical Systems

Absolutely. Well, first off, it's an important part of the compensation for the field, especially the territory managers. The management team shares in the same compensation structure, so they're all very consistent. We have different groups of people. We have the area business managers, as you know, that focus on opening new centers, and the territory managers that are responsible for cultivating the existing centers to increase utilization. In the past, we used to compensate more. Everybody gets their base comp, and of course, they get their commissions based on implants and revenue and units sold, but we have added components. In the past years, it's been based on what we call patients expecting therapy or more around patients in the prior authorization process.

As we continue to mature, it's important that we shift that from individual patient count to more utilization at site. We've kind of switched over the parameters starting this year to really focus more on the utilization site. I think we just presented it at the national sales meeting just a week ago, and the team's very excited about the progress that they made last year as well as the prospects moving forward.

Mike Polark
Director of Medical Supply and Devices Analyst, Wolfe Research

My second one, if I may, be a leverage related question. You report SG&A in a consolidated line. I don't see a breakout in filings or the like of S&M versus G&A. I'm just curious, as you assess kind of the leverage that you're seeing in the model, is there a variance worth calling out as to how your G&A spend is getting leveraged versus S&M? Just if you could frame up like, you know, where G&A is as a portion of total and is that getting materially better versus S&M or are they about trending the same? Any color there would be great. Thank you so much.

Rick Buchholz
CFO, Inspire Medical Systems

Hey, Mike, it's Rick. We have demonstrated leverage across all those line items, R&D, G&A, and sales and marketing, as over the Q4 and throughout the year in 2022. Again, we're gonna lose that in Q1 with seasonality. Even R&D, we're continuing to make investments. R&D was 19% of revenue in the Q3 , that was 15% in the Q4 . G&A is in that 10%-12% range. We expect to continue to be in that ballpark, in that range going forward.

Mike Polark
Director of Medical Supply and Devices Analyst, Wolfe Research

That's helpful. Thank you.

Tim Herbert
President and CEO, Inspire Medical Systems

We're getting leverage across all line items.

Mike Polark
Director of Medical Supply and Devices Analyst, Wolfe Research

Yep. Thanks.

Tim Herbert
President and CEO, Inspire Medical Systems

Thanks, Mike.

Rick Buchholz
CFO, Inspire Medical Systems

Thanks, Mike.

Operator

Thank you. Our next question comes from Chris Pasquale with Nephron Research. You may proceed.

Chris Pasquale
Partner and Senior Analyst, Nephron Research

Thanks. Hey, guys. Tim, I wanna follow up on the question-

Tim Herbert
President and CEO, Inspire Medical Systems

Hey, Chris. Go.

Chris Pasquale
Partner and Senior Analyst, Nephron Research

Hey. I wanna follow up on the question about the shift in incentive comp. The guidance for this year implies we add about as many sites in 23 as you did in 22. Just wanted to see, like, how you square that with where you're incentivizing your team to spend their time. Maybe we're reading too much into that comment, but it seems like that could mean fewer center adds this year.

Tim Herbert
President and CEO, Inspire Medical Systems

Well, I think we left the guide consistent from 22 to 23 because we still have our training team and the area business managers to be able to focus on adding new centers, and we're gonna continue with that. We also previously talked about how our growth has really been driven predominantly by increased utilization, same store sales versus the contribution from new centers. I think what we're kind of highlighting is we're gonna continue down that pathway. We wanna keep focusing on growing utilization because centers that are able to do more procedures, they get better outcomes. They're more proficient in the procedure. They're proficient on managing the patients. They're better at patient flow. They're better at submitting the proper codes to get proper reimbursement.

Centers that have high utilization are just so much more efficient and have higher patient outcomes. We're gonna continue with that trend and continue having territory managers ideally manage less centers that are doing higher utilization.

Chris Pasquale
Partner and Senior Analyst, Nephron Research

Okay, that makes sense. 78,000 physician contacts driven by your DTC effort is very impressive. You treated about 16,000 patients last year, one out of every five people who raised their hand are actually getting an implant. Where are the stumbling blocks today that are causing patients to fall out of that funnel? Can you talk a little bit more about the digital scheduling tool you mentioned and whether that's part of the solution for trying to improve that yield?

Tim Herbert
President and CEO, Inspire Medical Systems

Right. When we talk about the physician contacts, there's another sentence in there that talks about patients getting direct referrals from their own healthcare providers. That's not part of that number. There's always a little bit of specificity on where exactly the patients come from, and is it truly one in five from the Advisor Care Program? How many patients see the ad, they'll go to the website, they'll be educated, but rather than going through the Advisor Care Program, they will contact their own healthcare provider or their own sleep physician saying, "What do you think about Inspire? Will this work for me?" They actually will become a direct physician referral, not coming through from the Advisor Care Program. That's really an important part of the business as well.

We have to continue to educate sleep physicians. On the other side, we need to continue to improve the efficiency of the Advisor Care Program. We do have a pilot out there right now to be able to log directly in to the scheduling at physician's office. When the Advisor Care Program talks to a potential patient, determines that, excuse me, they are a good candidate, that they can directly schedule in. We have a handful of sites up and active, and we're really looking to further expand that program earlier in the year.

Chris Pasquale
Partner and Senior Analyst, Nephron Research

Thanks.

Tim Herbert
President and CEO, Inspire Medical Systems

Thanks. Thanks, Chris.

Operator

Thank you. Our next question comes from Matthew Mishan with KeyBanc. You may proceed.

Matthew Mishan
VP and Senior Equity Research Analyst, KeyBanc Capital Markets

Hey, Tim. Hey, Rick. Thanks for taking the questions.

Tim Herbert
President and CEO, Inspire Medical Systems

Absolutely.

Matthew Mishan
VP and Senior Equity Research Analyst, KeyBanc Capital Markets

Yeah. I think I know this might be a little bit early to ask, but I think investors are encouraged about the improvements with the Inspire 5 once that gets through approval. Do you think as it gets closer, like, some physicians will wait for it to be approved, where it might actually delay, you know, some implants?

Tim Herbert
President and CEO, Inspire Medical Systems

Great question. I don't think so. We see this in the past with the new remote, with Bluetooth, with going to silicone leads, going to Inspire IV from the Inspire II. Now, that's back in 2018, but we just don't see that slowdown. Once we have the patient flow and the patients get scheduled, we'll just stay on the pathway. Inspire IV going to 5, while it puts the sensing inside the can, it doesn't have a dramatic impact, such as like when we go to future generations with auto CPAP or with auto titration. We don't expect to see any kind of slowdown, and we know the demand continues to be strong.

Matthew Mishan
VP and Senior Equity Research Analyst, KeyBanc Capital Markets

Okay. Excellent. A follow-up, just the PREDICTOR study with an initial readout in 2023. I think you mentioned at an industry presentation, you know, earlier this year there was some data published from another study. Can you, can you comment on, like, what that showed, and why that would be encouraging for the readout for PREDICTOR?

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah, absolutely. We finished the first 300 in 2022. At the same time, Dr. Weiner is a physician in Arizona. I'll give him a shout-out 'cause his paper was published several weeks ago with the first 100 patients. We're getting the data now from the first 300. Right now it's in the quality stage, meaning that we get physician overread of the data for quality control. We're right in that process. We also noted that there were patients with a higher BMI above 32. We actually are entertaining the opportunity to continue that study and actually increase to maybe add another 300 patients, go to 600, being able to widen the number of patients that we can treat with that. Very active program.

We're in the process of getting the quality control on the first 300. We're looking to just continue enrolling patients because the data is, we like what we see, and we think that we might be able to treat even a higher BMI population. You'll expect us to say that we'll be going to 600 patients soon.

Matthew Mishan
VP and Senior Equity Research Analyst, KeyBanc Capital Markets

All right. Thank you very much.

Tim Herbert
President and CEO, Inspire Medical Systems

Absolutely. Good to hear from you.

Operator

Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. Our next question comes from Suraj Kalia with Oppenheimer. You may proceed.

Suraj Kalia
Managing Director and Senior Analyst, Oppenheimer

Good afternoon, Tim, Rick . Can you hear me all right?

Tim Herbert
President and CEO, Inspire Medical Systems

Yes, Suraj. How are you?

Suraj Kalia
Managing Director and Senior Analyst, Oppenheimer

I echo the sentiments. Congrats on a nice finish to the year.

Tim Herbert
President and CEO, Inspire Medical Systems

Thank you.

Suraj Kalia
Managing Director and Senior Analyst, Oppenheimer

Tim, forgive me, maybe I missed the new store, same store metrics provided. If I could ask specifically the 225 or so sites added last year, how many implants did they do for the whole year?

Tim Herbert
President and CEO, Inspire Medical Systems

Yeah, we don't have that. I get what you're asking. We don't have that specific numbers in front of those. Remember how we do new sites, and a new site is anybody who has opened up during the year. Any site that we opened in the Q4 , obviously they were only able to do their first cases, correct? They do one or two cases in November, December. Anybody who opened up January first of 2022 is still in the same bucket of a new center, and they have the opportunity to reorder, right? Do additional patients through the year. Some of those can be productive accounts by the time they get to the end of 2022. It's kind of the way that we establish case centers, and we establish them per year.

Yeah, I don't really have the exact number of what % of the cases were, from the class of 2022.

Suraj Kalia
Managing Director and Senior Analyst, Oppenheimer

Hey Tim, how do you define account turnover?

Tim Herbert
President and CEO, Inspire Medical Systems

First, let's define account. An account is a purchasing unit, right? That would be a hospital that orders product from us. That's what we call a center. A center can have several different accounts per se. There, there may be, kind of comes back down to, who's on the website, right? We don't have one center on a website. We could have multiple centers on there, right? The sleep practices could be on the website along with the implanting surgeon's website. Turnover, we don't have a whole lot of center turnover. Those are purchasing units. Sometimes they'll go on hold if a surgeon moves. Go ahead.

Suraj Kalia
Managing Director and Senior Analyst, Oppenheimer

I guess, Tim, what I was really getting at, just trying to get my arms around, you know, you'll have 905 sites exiting FY 2022. Great. Does 905 really imply that onboarding was, I don't know, pick a number, 1,100, and then some bled out, you know, for the various reasons that you've mentioned on calls in the past. They didn't do implants, you know, kick them out the list and all that, and then you'll exit it at 905. You know, just kind of trying to understand what the turnover is, you know, how many don't come back, so to speak.

Tim Herbert
President and CEO, Inspire Medical Systems

Very low. Very, very low. I don't think in the Q4 we really closed any sites. What you see is additive and 905 is the active number of centers. During COVID, we reported, I think once we closed 15 sites, another time we closed like 12. By the way, some of those sites have a surgeon move back in and are back in process. We have very, very low turnover of a site once they become active. Now we wanna continue to work with that site to be able to increase utilization. Doesn't mean a site if they're not productive or if they have too much of a backlog of patients that they're scheduling out too late, we'll remove them from the website. The website and an active center are two independent functions.

Suraj Kalia
Managing Director and Senior Analyst, Oppenheimer

Gentlemen, thank you for taking my questions.

Tim Herbert
President and CEO, Inspire Medical Systems

Suraj, good to hear from you.

Operator

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.

Tim Herbert
President and CEO, Inspire Medical Systems

Thank you, Josh, thanks for 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 consistent patient outcomes. The Inspire team's commitment to patient 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., 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. Please stay safe and healthy.

Operator

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

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