Inspire Medical Systems, Inc.

and welcome to Inspire Medical Systems fourth quarter and fiscal year 2020 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Mr. Bob Yadid of LifeSci Advisors. You may proceed with your

Thank you, Laura, and 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, INSPIRE released financial results for the three and 12 months ended December 31st, 2020. A copy of the press release is available on the company's website. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. All forward-looking statements, including without limitation, operations, financial results and financial condition, investments in our business, continued effects of the COVID-19 pandemic, full year 2021 financial and operational outlook, and improvements in market access are based on our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements. See our filings with the Securities and Exchange Commission, including our annual report on Form 10-K, to be filed with the SEC today 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 23rd, 2021. And with those prepared remarks, it's my pleasure to turn the call over to Tim Herbert, CEO. Tim?

Thank you, Bob. Thanks everyone for joining the call today for our fourth quarter and full year 2020 business update. Let me begin by expressing my gratitude to the entire INSPIRE team for their immense efforts through the significant challenges we all face in 2020. No one could have envisioned the effects of the COVID-19 pandemic and the necessary stoppage of procedures in the first half of the year. and during the resurgence late in 2020 and a continuation into 2021. As a team, we made a commitment to stay focused on our patients and to steadfastly prepare for the time when centers were again able to offer Inspire Therapy. As a company, we maintained our field expansion and continued to reach out and educate potential patients and physicians We leveraged digital tools to continue community health talks about the therapy and supported virtual appointments. These efforts resulted in a very quick restart to our business as reported in our third quarter call. And I am very pleased to announce this momentum continued and we had an extremely strong fourth quarter as well. In the fourth quarter of 2020, we generated worldwide revenue of $46 million, which was an increase of 71% compared to the fourth quarter of 2019. Importantly, while there was some pent-up procedure demand from earlier in the year from patients previously scheduled for implant but delayed due to COVID, This growth was largely driven by the additional centers and territory managers we continued to add throughout the pandemic and the increased number of procedures occurring at existing centers. As I stated on our last call, our INSPIRE team, the centers, and all health care providers have continued to adapt and identify safe ways to operate and treat patients in need. we are pleased as a number of potential patients seeking information about inspiratory therapy and those that underwent diagnostic and implant procedures during the quarter has returned to pre-COVID levels. Of course, as we have seen, business conditions during COVID are always evolving and we continue to monitor the impact of the pandemic. In late 2020, and into early 2021, we experienced some cancellations and delays in localized cases in select states. Currently, most centers are back scheduling cases, and we do not expect to see a sustained impact going forward. We expect our normal Q1 seasonality due to high deductible insurance plans resetting at year end and increased caseloads as patients sought to have their procedures completed in the fourth quarter. Even though seasonality may be more pronounced than in past years, we are already experiencing a rebound in procedure scheduling. With this in mind, and assuming continued normalized operations, our strong performance in the second half of 2020 and the positive trends in implant activity provide us with the confidence in the outlook for our business for 2021. Therefore, we are providing full-year 2021 revenue guidance of $183 to $188 million, which would represent an increase of 59% to 63% over a full year 2020 revenue of $115.4 million. To reiterate what I said earlier, our impressive results in the second half of 2020 and our confidence in our prospects for 2021 are indicative of the forward planning and preparation during the peak of the pandemic. Of course, as always, our primary focus remains on the patients to ensure that each and every one has the best possible outcomes from Inspire Therapy. With that, let's now get into the details surrounding the fourth quarter. Beginning with capacity, during the fourth quarter, we added 55 new U.S. implanting centers, ending the year with a total of 425. This is well above our guidance of adding 28 to 30 new centers in the fourth quarter of 2020. Several of these new centers continued to be carryovers from earlier in the year, but we continue to pursue an expansion in the number of centers and plan to open 34 to 38 new centers per quarter in 2021. Included in this increase in new centers is a growing number of ambulatory surgical centers, or ASCs, driven by the favorable reimbursement environment. We will continue to add both hospitals and ASCs going forward and do expect to see a growing percentage of inspired procedures being performed in ASCs. Regarding the U.S. sales team, we created nine new sales territories in the fourth quarter, bringing our total to 107. For the full year, we opened 34 new territories, a 47% increase over the 73 territories at the end of 2019. As I noted earlier, we did not slow our cadence of hiring territory managers during the peak of the pandemic to ensure that we were in a strong position once cases were able to resume. During 2021, we plan to increase our cadence of opening new sales territories by adding eight to nine new territories per quarter compared to our guidance of six to seven in the fourth quarter of 2020. We also continued increasing the number of regional managers and field clinical representatives ending 2020 with 20 and 44 respectively. The addition of new centers and the continued build-out of our field organization will increase our capacity and will remain one of our core focus areas for 2021. Our other strategic focus to increase capacity is accomplished by increasing the utilization at existing centers. Our challenge in 2020 was that utilization was significantly impacted by the pandemic. And while we have made significant progress in the second half of 2020, we expect this to further improve in 2021. To make this point, historically about 50% of our growth was from opening new centers and about 50% was from increased procedures at existing centers. For the year 2020, however, This was skewed to about 65% of the growth coming from opening new centers. We plan to focus on increasing utilization at existing centers, and as a result, expect growth between new and existing centers to be more balanced during 2021. The second key area of focus is to improve our ability to assist patients interested in Inspire Therapy by making a connection with a qualified healthcare provider. Our outreach programs are very effective in generating interest in Inspire Therapy, primarily through the InspireSleep.com website. During 2021, we plan to streamline this process even further for the patients. To accomplish this goal, we are continuing to broaden our call center concept, the Inspire Advisor Care Program, or ACP. The primary purpose of this program is to assist patients with making a connection with a qualified healthcare provider based on their specific needs. We ended 2020 with approximately 180 of our centers utilizing the ACP, and the ACP answered about 25% of all calls to physicians. We plan to significantly increase the number of centers under the ACP to nearly 500 by the end of 2021. This will enable the majority of the calls to be answered through the ACP. To leverage this expansion, it is essential for us to stay active in identifying and educating new patients. Creating this awareness remains the core objective. of our direct-to-consumer activities. To this end, we refreshed our outreach programs, including filming four new TV commercials, which we started airing in January. We also continue to utilize our website and online tools to help patients connect with physicians. For 2020, the number of visitors to our website was over 4.8 million. In addition, Nearly 62,000 physician contacts were established via the website, representing a significant year-over-year increase of 73%. Combining this growth with the effectiveness of the ACP has us in a strong position to increase the adoption of the therapy. Switching gears to reimbursement, I'd like to highlight that 2021 will be our first full commercial year without a significant reimbursement-related headwinds in the United States. This means that we can focus on scaling our business. As you know, in 2020, all Medicare local coverage decisions, or LCDs, were formally published and we have Medicare coverage in all 50 states. On the commercial policy front, we added 11 positive policies in 2020 covering a total of 55 million lives. And today we have policies representing over 220 million covered lives. At this point, Anthem is the last of the large commercial payers in the U.S. that has not yet agreed to provide coverage for the Inspire Therapy. Despite this, we have had success supporting customers with obtaining prior authorization approvals, including with Anthem. Looking at the prior authorization metrics, in the fourth quarter, our internal reimbursement team supported 1,452 prior authorization submissions. This compares to 988 submissions in the fourth quarter of 2019 and 1,233 submissions in the third quarter of 2020. The news regarding prior authorization approvals is also positive. In fact, 1,276 patients received an approval in the fourth quarter compared to 751 approvals in the fourth quarter of 2019 and 1,039 approvals in the third quarter of 2020. We continue to experience increased approval rates into the high 90%, and further, the median time for an insurance approval remains at approximately 12 days, down from 25 days in 2019. These rates have improved significantly due to the large and growing number of positive coverage decisions. As we have said previously, given the improved reimbursement environment for Inspire Therapy, these metrics are less meaningful in evaluating the overall progress of our business going forward, and we will no longer report on these metrics after today's conference call. Staying with reimbursement, but switching to coding. As we discussed on our last call, the new CPT code was approved and the process to determine the surgeon reimbursement rates is ongoing and is expected to become effective January 1st, 2022. In the interim, the surgeon payment was significantly increased by $450 in 2020 with the Medicare policies providing a payment for the sensing lead category three new tech code. This is a meaningful additional payment for surgeons as the average Medicare reimbursement for the base code is $600 to $800. This payment for the pressure sensing lead was also adopted by most commercial payers. From a facility perspective, the new CPT code should not change the payment to the hospitals or the ASCs. A new Category 1 code was approved for the drug-induced sleep endoscopy, or DICE, diagnostic procedure. This has also been an ongoing challenge for ENTs and facilities, and the more appropriate reimbursement provided by this new code should resolve this frustration. Moving on, Europe also had a very strong quarter, driven by improved patient flow, particularly in Germany and the Netherlands. Effective January 1st, Inspire Therapy is now integrated into the German hospital reimbursement system with a formal DRG. Since 2016, Germany's reimbursement for the Inspire procedure has been provided through the NUB process for new diagnostic and treatment procedures. The decision to include Inspire into the DRG catalog demonstrates that our procedure has become part of routine clinical practice in Germany. In Japan, we continue discussions with the MLHW regarding the reimbursement of Inspire Therapy. Our team met in person with the MLHW last week, and while we do not have a resolution to date, we remain active in discussions and expect to meet in person again in early Q2. Our expectation remains that Japan reimbursement should be consistent with the U.S. and Europe, and to this end, we will remain patient and continue the ongoing discussions with the Japanese authorities. Switching gears to R&D. Similar to the third quarter, we increased our R&D expenses year over year in the fourth quarter as we continued to invest in enhancing our technology platforms. The INSPIRE Cloud project, our cloud-based patient management system, continues to advance with the addition of a substantial number of centers in the U.S. and in Europe who are using the tool. In 2020, we launched the INSPIRE Sleep app for use on a patient's smartphone as an educational tool. Version 2 of the app was released later in the year and interfaces with the Inspire Cloud and allows physicians to collect clinical data from patients directly. The Inspire Cloud project and the Inspire Sleep app are the first steps in establishing interconnectivity between the patient and their healthcare provider. The next step is FDA submission of the new patient remote, which will be Bluetooth-enabled to allow for data from the implanted system and data collected by the remote to be uploaded to the Inspire Cloud via patient smartphone using the Inspire Sleep app. We anticipate that the new patient remote will be submitted to the FDA in the second quarter of 2021. Longer term, the design work for our fifth generation Inspire Neural Stimulator continues to progress. As previously discussed, We anticipate that this will be a multi-year effort to develop the INSPIRE V device and obtain regulatory approval. We continue to conduct feasibility trials with several technology innovations, which will make the INSPIRE V Neural Stimulator state-of-the-art and expect that it will further improve the performance of the system, including simplifying the implant procedure. Finally, I'd like to welcome Brian Phillips to INSPIRE. He recently joined our team as General Counsel, Chief Compliance Officer, and Secretary. Brian is an accomplished legal executive with broad corporate experience in the healthcare industry and understands the dynamics involved with a growing medical device company through his years at Sermonix. We welcome Brian to the team and look forward to his meaningful contributions. In summary, We continue to experience significant momentum in all key areas of our business. Implant activity trends remain highly positive, and we continue to be well-positioned to assist patients as they progress on their Inspire Therapy journey. As I stated earlier, our core focus for 2021 is to continue to expand our business by increasing capacity and improving the process to connect patients with the proper healthcare provider. We also intend to achieve further advancements and reimbursement that build upon our recent positive coverage decisions, continue our efforts to strengthen the growing body of clinical evidence in support of Inspired Therapy, and invest in the continued development of our innovative R&D platform. We remain extremely excited about the future prospects and are confident that we will have the appropriate strategy in place to drive long-term shareholder value. With that, I'd like to turn the call over to Rick for his review of our financials.

Thanks, Tim. I would also like to begin by recognizing the entire INSPIRE team for their tremendous effort in 2020 as we faced unprecedented challenges. Based on our fourth quarter results, We believe that we are well positioned to expand the adoption of Inspire Therapy, positively impacting the lives of patients with untreated obstructive sleep apnea. We are entering 2021 in a strong financial and operational position. Total revenue for the fourth quarter of 2020 was 46 million, a 71% increase from the 26.9 million generated in the fourth quarter of 2019. US revenue in the fourth quarter was $42.7 million, an increase of 72% from the $24.9 million in the prior year period. In the fourth quarter, European revenue increased 64% to $3.3 million. The US average selling price in the fourth quarter was approximately $23,800, which was consistent with the prior year period. The European ASP was about $23,600 during the quarter, compared to $22,400 in the fourth quarter of 2019. The higher European ASP was primarily driven by favorable changes in foreign currency exchange rates. Our gross margin in the fourth quarter was 84.4%, consistent with the 84.2% gross margin achieved in the prior year period. Total operating expenses for the fourth quarter were $45.9 million, an increase of 44% compared to $32 million in the fourth quarter of 2019. This increase was primarily due to investments in the expansion of our sales organization, as Tim highlighted, as well as increased direct-to-consumer marketing programs, continued product development efforts, and general corporate costs. As we noted on our previous earnings call and recent webcast presentations, the increase in operating expenses is reflective of our plan to achieve continued growth and our consistent focus on furthering investing in our commercial and development initiatives. Our net loss for the fourth quarter was $7.5 million, a decrease compared to $9.1 million in the fourth quarter of 2019. The net loss for the fourth quarter was $0.28 per share, compared to $0.38 per share in the fourth quarter of 2019. For the full year 2020, our total revenue was $115.4 million, a 41% increase from the $82.1 million generated in 2019. The US revenue for 2020 was $106.1 million. an increase of 44% over 2019. European revenue in 2020 was 9.3 million, an increase of 11% over 2019. Given the significant progress we have made in scaling our business, we are providing full year 2021 revenue guidance in the range of 183 to 188 million. which would represent growth of 59% to 63% over full year 2020 revenue of $115.4 million. Historically, and similar to other elective procedures, we have experienced some seasonality in our business. In the US, we have higher procedure volumes in the fourth quarter as patients with high deductible health plans seek to schedule procedure prior to their deductibles resetting at the beginning of the year. We also experienced some localized delays in scheduling cases due to the pandemic resurgence in late 2020 and early 21. However, we do not expect that these delays will be sustained. Given these factors, we anticipate that seasonality may be more pronounced than in past years. Moving to the balance sheet. As of December 31, 2020, our cash and investments totaled $234.4 million. This strong cash position allows us to continue to execute on our growth strategy of increasing patient flow at existing centers and training and opening new implanting centers. The weighted average number of shares outstanding for the fourth quarter was $27 million. We anticipate that the weighted average number of shares for the first quarter of 2021 will be approximately 27.1 million. In summary, our business is performing extremely well. We are very pleased with our results in 2020 and are excited about our long-term growth prospects. With that, our prepared remarks are concluded. Laura, can you please open up the call for questions?

At this time, we'll be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary for you to pick up your handset before pressing the star keys. Please limit yourself to one question and one follow-up. One moment while we poll for questions. Our first question comes from the line of Richard Kneewater with SVB Learing. You may proceed with your question.

Hi. Thanks, guys, and congrats on a fantastic quarter and impressive guide there. Just to start off maybe on the guidance, do you think there's a sense as to what you're assuming in terms of the percentage of accounts that ASCs will comprise in 2021? I think you said in 3Q, it was 15%. I'm not sure what you said it was in 4Q. And can you remind us what the utilization differences are between kind of what can get done in an ASC versus other settings?

Absolutely. Hi, Reg. We did increase the number of ASCs in the fourth quarter, and it's still just above 15%. And it's a little early to be able to be measuring utilization between hospitals and We're going to continue to focus on both to continue opening those centers and keep that mix, although I think it's safe to say, as we mentioned earlier, that the number of procedures in ASCs will continue to grow probably faster than they will in hospitals because of the number of ASCs that we'll bring on board. Got it. Thanks, Vince.

You know, in the past, we've asked you, you know, why aren't you going harder and faster at the opportunity and hiring reps faster? And you've always said, you know, you want to make sure and preserve the quality of procedures, doing the procedures, et cetera. Well, here you are kind of talking about, you know, 34 to 38 new accounts per quarter, and you definitely are planning on some territory expansion that's above consensus. So I guess the question is, what's changed in giving you the confidence to be able to push the pedal to the floor a little bit here? And, you know, it feels like there's definitely a strong inflection here. So maybe you could elaborate on that a little bit. Again, congrats.

Yeah, thanks for asking that and bringing the quality into it because that remains our number one focus, and that is all about patient outcomes. We always talk about a balance between growing fast and maintaining strong patient outcomes. So As we have scaled the organization, remember we talked about in 19 going to the four area vice presidents and the regional manager and allowing us to scale. But we always had the headwinds of reimbursement that limited our ability to really ramp up too fast. But now this year with the reimbursement headwinds kind of behind us and moving through that, we have also scaled our training team. And so as we start to open up additional centers and bring on additional new sales territories, we can do that by maintaining the same quality because our training procedures have improved and just expansion of the training team in general to be able to control those outcomes. And then I'd also want to add, remember we've also brought in a new focus to field clinical reps, right? And we're looking to increase the ratio of field clinical reps to territory managers. to be able to help the in-service of the technology, but also help the operation procedures. So we are not moving away from quality. We'll make sure that is number one on the list, but we're comfortable that where we are today and with the reimbursement environment, we can scale the business a little quicker, and that's why we're being a little aggressive there. Thank you. Thank you, Rich.

Our next question comes from the line of Chris Pasquale with Guggenheim. You may proceed with your question.

Thanks and congrats on a great year. I'm curious whether guidance assumes anything from either Japan or Australia, the two new territories that you're still waiting on some reimbursement progress from.

No, from my comments, Japan, we did have a face-to-face meeting with them. We don't have agreement on reimbursement yet. We have action items that we'll be working in concert with the MLHW over the next six weeks, and we hope to be meeting again in person with them in the second quarter. Our intention is certainly to come to agreement, but our expectations remain that reimbursement in Japan should be consistent with the United States and in Europe, and we're going to continue to pursue that and provide the evidence that necessary to to show that that's appropriate. So we did not build that into any of the guidance in 2021. We would like to do the first implants in Japan in 21, but really set up for a broader launch in 22. As far as Australia goes, we do have approval from a regulatory standpoint, but we don't have the reimbursement to be able to launch there. That's going to be an ongoing activity. We are in communication with the regulatory, or I'm sorry, the reimbursement authorities in Australia as well, but we have not built that into 2021 either. Okay.

And then, Tim, you talked a lot about trying to get new sites as they're coming on to commit to giving you a couple OR days a month to try and ramp that number of procedures per cent. effectively you've been able to sort of get that messaging through and get centers to buy into that. And whether the ramping up of the call center to cover a bigger proportion of your installed base is a key element to that because that really puts you guys in the mix in terms of filling those days.

Absolutely. That's a great question. I'm going to have you ask. make sure you hold on to that question for subsequent quarters. Unfortunately, right now, we don't have the data to be able to back that up. But that's exactly what our hypothesis is, is that if we can get centers to really commit more OR time, then centers can know that the procedures are coming up. And it's not just the surgeons. It's the OR staff. It's the people in the operating room. They know what to expect on this day. And the people in the coding and reimbursement, they know what to expect when billing it. And there's a consistency across the board that makes centers better skilled at taking care of numerous patients. Remember, Inspire Cloud is also built to build efficiencies into centers. And then adding, bringing ASCs back into the discussion, we believe ASCs will have a little bit more flexibility in committing days to inspire procedures, and so their staff can plan for that. But I think this is going to be something that we're going to continue to monitor, and we'll monitor that utilization closely going forward. And the ACP, the Advisor Care Program, will really help us bring qualified patients to the ENT. And as we move forward and get the majority of our centers on the ACP, I think we'll be able to give you evidence that that is, in fact, being successful. Thanks.

Our next question comes from the line of Robbie Marcus with JP Morgan. You may proceed with your question.

Oh, great. Congrats on a great quarter. Hi, Robbie. Really, just one question from me. You know, you talked about how in fourth quarter you got back to pre-COVID levels and you don't really expect much disruption in 2021 here. You know, that's definitely counter to what we hear from most other med tech companies. So I guess the question I really am trying to dig into is, you know, you got back to pre-COVID, but is there still some number of patients or volumes that are being left on the side? And getting back to where you were pre-COVID, you know, could there still be a bolus in 2021 and into 2022? There's still probably a lot of patients who would have gotten therapy that didn't.

Absolutely. Again, I go back to what we were talking about a little bit earlier. In the fourth quarter, we did have a little bit of the backlog that we were working from from the COVID period. And so that was a significant increase. But also the 55 centers we opened, a number of them have been in the works for quite a while, but they just weren't able to open up until the centers were able to restart. The second part of that, is we did see an impact of the research of the pandemic, probably mostly in December and then into January. So yes, we're experiencing the same challenges every other company is seeing as well, but we're starting to see most of our centers reopen and reschedule the cases. And so we don't see that as a sustained challenge going forward. And as Rick commented that We may have a little bit more seasonality because it's impacted a little bit more from the resurgence of COVID-19 in the beginning of Q1. But we think as a whole for the year, we think we're in pretty good shape. And that's why we're putting out a little bit of an aggressive guidance going forward.

Well, that's great to hear. Appreciate it. Thanks a lot.

Thanks, Robbie.

Our next question comes from the line of Lauren Spiegelson with Wells Fargo. You may proceed with your question.

Thank you so much. This is for Larry. Just a few questions from me. So on the guidance, I was just wondering if you could elaborate on the cadence of revenue growth and OPEC spend through the course of the year. I know you did give some color on Q1. And then, you know, is there operating leverage opportunity in 2021? And how should we think of DTC investments this year?

Yeah, hi, this is Rick. Thanks for your question. As we just talked about, you know, we're watching Q1 closely with seasonality, but We do not provide quarterly guidance, but we do think we will have a little bit more pronounced seasonality in the first quarter because of some of those resurgence of COVID impacting in certain areas in December as well into January. But on an overall basis, we're confident on our full year guidance, which is really represents 59 to 63% growth. So From a guidance standpoint, that's our annual guidance. From an operating leverage, we did have improved leverage year over year as we had a strong fourth quarter on the top line. We are still investing in our business. We're in the early innings, if you will. We're in 425 centers. We're going to continue to add 34 to 38 on a quarterly basis going forward. And we're going to also continue to increase the number of territory that we had. We did increase our DTC efforts. We produced four new commercials in the fourth quarter, and we will start to air them in 2021. And so you'll see in our 10-K that's filed that our DTC was about $26.4 million for the full year 2020. And in 2019, it was $18 million. So we're going to continue to support our expansion with increased ETC efforts.

I got it. That's helpful. And then if I could just ask a question on competition. Are you seeing anything from Nioxa in Europe? You know, as you know, they are conducting a study in Australia in patients with and without CCC. You know, if their study is positive in that patient population, you know, how would that impact, inspire, And then separately, I'm sure you saw signify medical received approval for Excite OSA device. Any thoughts there would be helpful. Thank you for taking the question.

Great. Thanks for your question. From an Ixoa standpoint, we haven't really seen impact yet. We know they're conducting trials. We think that's wonderful. And we will anxiously await to see that data and see how that data comes out. So we don't make any other comments on that. I know they're pursuing some clinical work in Europe. as well as in the United States, and we think that's good for them to continue to collect clinical evidence and be in a position to present that in the near future. So as far as signifier and the other competition, I don't think we have really any comments at this time. We'll wait until they start to issue some data, and we'll just focus on taking care of our patients and making sure that we maintain our own safe and effective outcomes. So thank you very much.

Thank you. Our next question comes from the line of John Block with CFO. You may proceed with your question.

Thanks, guys. Good afternoon. Hey, Tim. Maybe for the guidance, just to start there, is this call, you know, still the same approach with the conservatism that we saw in prior years, notably in 18 and 19. And then on the 2021 gross margins, Rick, the midpoint 84% is a bit below where you've been. And when I think about the variables, you've got stable U.S. pricing, you arguably have higher international pricing due to FX, and you're certainly increasing volume. So why would we see, even though it's slight, why would we see that step back in gross margin? And then I just got to follow up.

Alright, let me take the first and I'm going to hand it over to Rick and he can talk about gross margins. From a guidance standpoint, where we stand today is we're watching the environment that we all live in. And so as we kind of discussed with Ravi's question, just watching how COVID rebounds quickly and our ability to continue to open up these centers, continue to drive utilization, get the advisor care program. Remember at end of the year at 180 centers, we need to quickly keep adding on more centers taking more, a higher percent of the calls, because we believe that that will have, improve our ability to connect patients with their healthcare providers. So we did want to put out guidance that we're comfortable in. We have done that in the past. We're not changing that strategy going forward. But again, there's a lot of work that needs to be done as we get through this pandemic and into get life a little bit back to normal. And even last week, we feel for the people down south with the weather. And I mean, we ourselves lost our warehouses right next to HealthLink and right next to FedEx in Memphis. And we lost several shipping days. Our team is resilient. We're able to move product to be able to cover cases throughout the U.S. We don't think that's going to have an impact, but that's just a lot of the ongoing challenges that we have to face. And we are happy to see it's warming up down there and everybody gets back to normal there too. So again, confidence in our guidance, but we always give you ranges that we believe that we can achieve. But that doesn't mean there's still not a lot of work that we need to deal with. And let me hand out to Rick for gross margin.

Yeah, gross margin's pretty straightforward. We do still have a little bit of variability at a quarter to quarter basis. We're still working off a relatively low base and so we're at 84.4% is down a little bit from from the third quarter. But again, as Tim mentioned, we're putting forth our guidance 83 to 85% for 2021 so. I think that's enough.

Yep, that's helpful. And Tim, that was a very helpful perspective on the 2021 guide. I think to zoom out for a moment, Tim, can you revisit cohort data in sort of any color on the earlier classes of hospitals? Are they still growing? And if so, you know, what does their growth trajectory look like, the more recent cohorts? And then sort of attack onto that more broadly speaking, you know, the physician payment coupled with dice could increase a really good amount in coming quarters. Can you talk about this as a potential opportunity for Inspire to reengage with previously trained docs or centers that, you know, might be running at suboptimal utilization? Because of some of the challenges they encountered earlier on in the process. Thanks, guys.

Absolutely. It's a great opportunity. I think the newer centers understand the new reimbursement environment, so they're coming in with a certain level of expectation. and we want to get them up to a higher implant level, but we don't want to lose sight on the early adopters who, remember, a lot of them are the large academic centers. Okay, now when you think of 2022 and you think about all the news and you look at all those huge academic hospitals taking care of all the COVID cases, that put a challenge on the utilization of our classes, because the early classes are a lot of those top, top centers, which were the top centers committed to addressing the pandemic. So they're still rebounding and they're still coming back. And I think long term, the story will be very, very strong. But as we mentioned in the comments, a higher percent of our growth last year was from opening new centers, not from increased utilization. And we want to see that get back to normal. I think we can do that Again, especially based on what you highlight with the improved reimbursement for the physicians and even the reimbursement for the centers not having to deal with risks of not getting paid for Medicare. Got it. Thanks, guys. Thank you, John.

Our next question comes from the line of Bob Hopkins with Bank of America. You may proceed with your question.

Hi there. You have Brad Bowers on for Bob tonight. Thanks for taking the question. I have a question on ASCs. I know one of your partners, USPI, just acquired 45 ASCs in December, at least they announced the plans to. So I was just wondering if that was contemplated in your guidance or how quickly you think that you would be able to penetrate those new centers.

Great question. I think it's probably that's a real detailed specific. I think I commend them on acquiring 45 ASCs, but we're still at the very beginning, working with USPI and identifying which of their ASCs will be adopting Inspire. And I think over the last couple quarters, just a handful have really started Inspire programs so far, but they will continue in earnest with USPI. But also, what was the other second one? SCA, Surgical Care Affiliates. Yeah, so we'll continue with their, and there's also others that we are working to develop national pricing agreements with. So big focus area, just really early in the game right now. And, again, really don't have specifics around their addition of 45, which I think is great for them.

Got it. Thank you. And then just one sort of follow-up, I guess just touching on – I think this kind of got touched on a little bit, but just to ask it more specifically – How should we think about revenue per center growth as you penetrate deeper into ASEs? Do you think that that growth will slow as some of the centers come on? Or do you think that there's enough deeper penetration within some of the older, more recent cohorts to kind of keep that chugging along? Thank you.

Well, thank you very much. I think we want to make sure we continue to improve on that. And we always talk about units per center per quarter. And even though we're bringing on a lot more centers, as we did 55 in the fourth quarter, and that increases the denominator, which kind of pushes the utilization down a little bit, we're going to keep driving that utilization to keep that number growing. And I think ASCs provide an opportunity to actually increase that, again, from their flexibility and scheduling and their ability to take care of the patients and the nature of the implant being just a short two-hour outpatient procedure. Thanks much.

Our next question comes from the line of Amit Hassan with Goldman Sachs. You may proceed with your question.

Oh, thanks. Hey, good afternoon. I'll keep it quick, just a couple quick ones. Just first of all, just on the first quarter, just making sure if I kind of read your comments correctly, it sounds like February is actually gotten better from January. I wonder if you can comment on that, and then relatedly, if you look at the streets sitting here at 36 million for the first quarter, does that sound like it contemplates your seasonally comments enough?

Well, I mean, I'm going to just generally comment, and I do think that coming out of December to January, we did have a lot of regions affected by the pandemic, and we all watched the news, and We all know where those regions were from the, we transferred from the Midwest down to the Southeast, and we're having a lot of centers hold off on procedures from the Carolinas to Georgia to Alabama to Mississippi and a little bit into Florida. So there's always a little bit of concern there. We do see those centers scheduling patients now, and we do see just the normal seasonality starts to pick up in February as it does every year. So yes, it's safe to say that activity in February picks up than it does in January and we anticipate March will continue forward. So as far as the specific comment about where the street is in Q1, can't really comment on that as you know, but I do think that we will see a little bit more seasonality than we do in previous years. But again, we've been pretty aggressive in our overall growth of 59% to 60-plus percent growth throughout the year. So we think we're going to be strong in the second half of the year.

Okay. And just as a follow-up on your comments on Germany, maybe just a quick caller there would be helpful to just understand the significance of the DRG and what that could mean for the sales ramp there this year. Thanks so much.

Thank you. I think it really helps a little bit in Germany because Going from the NUB1, that's an annual negotiation that hospitals have to have with the payers. And when we go to a DRG, it really sets up a more permanent, formal reimbursement. And this year is a little bit variable because the centers do have to negotiate their individual rates this year. But when they negotiate the DRG, it allows them to include other parts of the procedure that were not previously reimbursed, such as sleep endoscopy, right, and other parts of the procedure. So it gives them an avenue this year to increase the reimbursement. I think you're seeing that a little bit with the ASPs. That's really driven by the exchange rate. But then after this year, that's when the formal reimbursement gets locked in. So I think long term, it really helps the centers that they don't have to negotiate this ongoing. But on top of that, it just gives credibility of the maturity of the therapy. And that allows us to open additional centers. We continue with the direct consumer outreach in Germany as well. We do have an active call center in Germany that's helping bring patients and connect them with their healthcare providers. So I think it's just the next natural step in a permanent reimbursement.

Our next question comes from the line of Adam Mater with Piper Sandler. You may proceed with your question.

Hey, guys. Congrats on the progress and nice finish to the year, and thanks for taking the questions here. I'll keep it to one. Just on Anthem, Tim, you know, you guys have made a ton of reimbursement progress over the past 12, 24 months. Anthem was really the only small hiccup last year. I know you're planning to reengage there or you're currently reengaging, so just latest thoughts around process and timelines and level of confidence that you're going to be able to overturn that negative decision. And I think you've talked about having some new data, post-market Germany RCT data being published here in the near future. So just any update on that as well. Thanks so much, guys.

Absolutely. Well, I was looking to see the number of publications that we put out last year just to show that that we spend so much time in our ongoing clinical evidence. And I think it's close to 50 peer-reviewed publications on Inspired Therapy were published in 2020. A couple of those, one of them was an idea from Aetna years back about it's a controlled study that patients with Inspired Therapy were compared to a group without Inspired Therapy. And the reason they didn't get Inspired Therapy is the insurance company didn't authorize that procedure. There's also a randomized study coming out of Germany that I know the authors have prepared a manuscript and they're submitting that. So that's a new level one randomized study that should publish this year. We have the adhere registry that is well over 2000 patients enrolled. So we'll continue to provide annual updates and build on that. So that being said, we're going to keep working on peer-reviewed published evidence. Number two is we have a strong focus for all Anthem patients have rights to Inspire Therapy. And we work with the healthcare providers for them to submit prior authorizations to Anthem, and Anthem is being very good stewards. Anthem is reviewing the cases, and they are approving cases. Now, unfortunately, the time to approval is longer than than that of a company with a positive coverage decision. But Anthem is approving cases, and we're seeing increased number of Anthem patients. And eventually, Anthem will review their own data as well as additional data from other peer-reviewed publications. So we have great confidence that we will convince Anthem that it's appropriate that they write a positive coverage decision. And we encourage them to continue to review and If it means we have to wait to their annual review in summer, so be it. But we'll continue to provide information as it becomes available.

Very helpful. Thank you.

Thanks, Adam.

Our next question comes from the line of Ravi Misra with Barenburg Capital Markets. You may proceed with your question.

Hi. Good evening. Thank you for taking the questions. I hope everyone's okay.

Hi.

If I could just start. Hi, Tim. Hi, Rick. If I could just start, you know, Medicare obviously is going to be a larger portion of your revenue this year. Just curious in terms of how we should think about it in terms of the growth guidance you've given and how to layer it in with the commentary amongst new centers and growth from existing centers.

Absolutely. Well, let's just go to the numbers and And I think it's all over the place and it changes quickly because we're in the COVID environment. We need to kind of let it settle down. But I think at the end of the year, we're kind of running somewhere about 70% commercial, 25% Medicare, and 5% VA and military. Now, interesting enough, VA and military are down quite a bit because those facilities were really not allowed to do elective procedures and they just started really late. So I think probably early in the year you're going to see a little bit more of a resurgent in the VA centers. But this is the first full year with the Medicare population and the Medicare decision. But you have to layer into that is the Medicare population is also tends to be the most susceptible to COVID. but that's also the population that is now being vaccinated. And so there's a lot of variables in there that you've got to kind of combine together, but it does provide confidence that Medicare is really going to have a strong year going forward. But we're not going to rest on that because if you kind of look at our direct-to-consumer marketing programs that we set up and even the four new TV commercials, that's really targeted for a commercial age group of patients. So what I'm trying to say is we're going to keep pushing all three elements to grow commercial, Medicare, and VA consistent with each other. It's probably going to be that commercial and Medicare will grow quicker than the VA just by nature of the limited number of VAs that there are in the United States. But it's a great question. I do think Medicare is going to have a really good year. It's great for the Medicare age population in that we have the policy decisions in place And now that we get control of COVID here globally, that we can increase the number of Medicare-age patients that can have inspired therapy.

Great, thanks. If I can ask maybe two more questions, and I'll put them up front. Maybe one on the product development side, one a bigger picture question. So, you know, you've stated in the past you're working on, you know, potential remote programming. Can you maybe highlight what kind of steps you need to secure approval with the FDA there in terms of studies or kind of clinical design? And second, just if we can think about value-based care and health care, you know, I'm not sure how much of that is really kind of coming into the sleep segment just yet. But maybe if you could help us understand, you know, three, four, five years from now, what, you know, research is Inspire going to be putting forward or what can be kind of thinking about to say, hey, you know, this procedure, this product is taking cost out of the system. Or, you know, do you not foresee that kind of in that time window?

Thanks. Ravi, that's a good question. While I'm thinking of a good answer, I'm going to answer your first question. That's pretty straightforward. The FDA has already approved remote programming, and they have established a new digital technology group at the FDA. In fact, our team is going to be communicating and set up a meeting. We still can't travel yet, but we're going to have a virtual meeting with that digital team, and we're going to lay out what our plans are. And the first step is this Bluetooth-enabled remote that's going to allow communication between Inspire Cloud and the implanted product. And that's going to the FDA in the second quarter, and hopefully the FDA will do a quick review of that. The next step is to be able to enhance Inspire Cloud to be able to allow a physician to log into that and work through the cloud to send instructions through the remote, or through the patient's smartphone, through the remote and reprogram the implanted product. Technology, we can handle it. We need to make sure that we do it in the proper sequence, keep the FDA fully improved of our plans and our processes, but we believe we'll be able to do that in the very near future. Value-based care. Long discussion has been in the works in medical devices for many, many years. It's very difficult to quantify because measuring the impacts of improving the criticality of sleep apnea and how that relates to reduced hypertension and how that improves early mortality. It's something that I know the CPAP companies have been struggling with for years, and it's very difficult to quantify that, but that doesn't mean that we're not going to keep trying. So as we get into the Adhere registry, that eventually is going to get folded into the Inspire Clouds. And we're going to build our evidence base and call it our big data to be able to collect that level of information. And we are even starting smaller scale outcome studies with some of the leading institutions to be able to show advanced benefits and to be able to show to the large payers that there is an economic benefit or a value from covering Inspire and if there's a way that we can work with them to identify what is that value. Again, as you know, that's going to take years for us to accomplish, but we know it's there and we know it's something that we want to accomplish. Very good, Rod.

Ladies and gentlemen, we have reached the end of today's question and answer session. I would like to turn this call back over to Mr. Tim Herbert for closing remarks.

I just have a couple comments, and I want to thank you all for joining the call today. I remain grateful to the growing team of dedicated Inspire employees for their enthusiasm, their hard work, and continued motivation to achieve successful and consistent patient outcomes. The Inspire 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 continue to grow our business in the U.S. and in Europe. For all of you on the call, we appreciate your continued interest and support of Inspire. Look forward to providing you with further updates throughout 2021. Everybody, please stay safe and healthy, and thank you again.

This concludes today's conference. You may disconnect your lines.