Neuropace, Inc.

Good afternoon, and welcome to NeuroPace's first quarter earnings conference call. At this time, all participants are listening on remote. We'll be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would like to turn the call over to Matt Baxo from the Gil Martin Group for a few introductory comments.

Thank you, operator. Good afternoon, and thank you for participating in today's call. Joining me from NeuroPace are Mike Favit, CEO, and Rebecca Kuhn, CFO. Earlier today, NeuroPace released financial results for the first quarter ended March 31, 2022. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including those around NeuroPACES clinical trials and those relating to our operating trends and future financial performance, FDA approvals, the impact of COVID-19 on our business, and prospects for recovery, expense management, expectations for hiring, growth in our organization, market opportunity, revenue outlook, commercial expansion, product performance, and product pipeline development are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those implied by these forward-looking statements. Accordingly, you should not place under-reliance on these statements. For a more detailed description of the risks and uncertainties associated with our business, please refer to the risk factor section of our Public Violence with the Securities and Exchange Commission, or SEC, including our annual report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 10, 2022, and our quarterly report on Form 10-Q to be filed with the SEC on May 12, 2022, as well as any reports that we may file with the SEC in the future. This conference call contains time-sensitive information, which we believe is accurate only as of the live broadcast on May 12, 2022. Neuropace 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. And with that, I will turn the call over to Mike.

Thanks, Matt. Good afternoon, everyone, and thank you for joining us. For today's call, I will provide opening comments and a business update, followed by Rebecca, who will provide additional detail regarding our quarterly results in full year 2022 financial outlook before opening the call to Q&A. Moving on to our quarterly results. We started the year strong, generating $11.4 million of total revenue for the first quarter of 2022. Initial implant revenue in the first quarter of 2022 was $8.8 million and came in above the top end of the first quarter guidance range. We experienced significant business disruption from January through early February, primarily as a result of the Omicron variant, resulting in one of our most COVID impacted periods to date. We rebounded nicely in the second half of the quarter. Specifically, in the second half of February, we saw a marked improvement in procedure volumes from January levels. Our business improved further in March when we saw a meaningful uptick in implant procedure volumes, which we believe to be a combination of rescheduled procedures from earlier in the quarter and new procedures. Given the COVID-19-related challenges faced in the early part of the quarter, we are pleased with our results. Although we experienced a nice recovery fueled in part by rescheduled implant procedures in March, we believe that severe COVID-related disruptions in January and February caused a significant reduction in the number of patients coming through epilepsy monitoring units or EMUs during that time. The patients coming through the EMU diagnostic process feed the pipeline for our RNS system implants. We believe that the EMU volumes largely returned to 2021 levels in March, as the impact from Omicron subsided, but that the reduced number of patients coming through the EMUs in the first half of Q1 will limit the number of patients implanted with the RNS system in the second quarter. Given what we saw in the first quarter of 2022, we believe that we remain on track for our 2022 revenue guidance of $45 to $48 million, as well as meeting our 2022 target of approximately 10% growth in centers implanting our RNS systems. Without additional COVID disruptions, we also expect that the number of patients coming through the EMU diagnostic process will return to pre-pandemic levels and continue to grow. We believe that there is a growing backlog of patients at the EMUs, both as a result of the most recent disruptions in the first half of the quarter, as well as the longer-term impacts of the COVID-19 pandemic. It typically takes approximately six months from initial EMU admission until the implant of an RNS system. Given this, we believe that our growth in 2022 will be driven by commercial execution, resulting in an increasing number of centers implanting our RNS system and increased utilization within those centers. We expect that longer-term growth will be assisted by an increasing number of patients coming through the diagnostic process. In anticipation of an improving environment with increasing EMU patient volumes, We previously announced a number of commercial initiatives. Specifically, we are on track with our accelerated field hiring plan with many of the new hires already in place. The larger field team will allow us to increase focus on epilepsy specialists who practice outside of level four centers. This provides additional market opportunity for our business. We plan to educate these epilepsy specialists about the RNS system. helping them collaborate with CECs to have our RNS system implanted. Through these relationships, we can make RNS therapy available to a larger number of patients with ongoing device programming and patient management provided by epilepsy specialists practicing outside the Level 4 CECs. We believe that the ability to have device monitoring and oversight done locally will have a significant benefit to patients. Of note, we are resuming in-person physician education events starting this summer for the first time since the start of the pandemic, and our field team access to customers has improved significantly. We believe this trend is a leading indicator of improved clinician engagement and future adoption. We are also driving demand generation by identifying and educating drug-resistant epilepsy patients earlier in their treatment journey as they consider treatments beyond medication. We are expanding our marketing programs, including an increase in digital and social advertising, lead generation efforts, and patient ambassador connections. As we connect with more RNS candidates earlier in their care journey, our patient education team will provide information about NeuroBase's RNS system and guide appropriate patients through the process. Moving on to recent clinical updates and future indication expansion opportunities. We remain on track to start enrolling patients around the middle of the year in our Nautilus pivotal trial to support a PMA supplement to expand our indication to include primary generalized epilepsy. While we are still early in our pursuit of generalized epilepsy indication expansion, we are excited about what this would mean for our business and for patients. In addition to expanding the RNS indication to cover a larger number of patients, there are important differences from our current focal epilepsy patient population that make this an excellent opportunity for our RNS therapy. Surgical resection and ablation are not appropriate for treatment of generalized epilepsy, and there are no other approved neuromodulation therapies for this patient population. We believe that the diagnostic process for generalized epilepsy will be faster and simpler than for focal epilepsy with less need for EMU evaluation and no need for invasive monitoring. Upon FDA approval, we expect a relatively fast commercial rollout because we anticipate selling to the same physicians who are already treating focal epilepsy patients using the same neuro-based device. We are excited to begin enrollment in the Nautilus study and look forward to an indication expansion into this underserved patient population. Next, I would like to provide an update on replacement implant revenue. As stated last quarter, we received approval from the FDA to update our labeling to claim an estimated average battery life of nearly 11 years under typical use conditions. This updated label represents more than a two-year increase from our previously approved labeling, and we have been actively marketing this benefit to customers. Early customer feedback has been very positive, as a longer battery life removes an important barrier for initial implant adoption and gives us a distinct competitive advantage over other neuromodulation devices for epilepsy, which have much shorter expected battery life. Revenue from replacement implants was $2.6 million in the first quarter of 2022, which came in slightly above the top end of our Q1 guidance range. Due to the timing of when the first-generation implants are replaced, There can be variations quarter to quarter. That said, replacement revenue trends remain in line with our expectations and historical replacement rates. To provide continued transparency, as of March 31, 2022, there were 207 patients being actively treated with first-generation devices. Replacement revenue trends remain unchanged, and we continue to expect quarterly replacement revenue to sequentially decline throughout the year, with a full year 2022 replacement revenue of approximately $6 million. In summary, we started the year strong, despite meaningful COVID headwinds in the first half of the quarter, and continue to make significant progress on key strategic initiatives. On the clinical side, we remain on track to begin enrolling patients in the Nautilus study around mid-year. which will be an important step to expand the market opportunity for our R&S system. On the commercial side, we increased the number of centers implanting our R&S system in the first quarter and are on track with our field team expansion and patient demand generation initiatives. All of these position us well as we anticipate EMU patient volumes increasing, leading to more patients being deemed candidates for our R&S system. With that, I will turn the call over to Rebecca, Neuropace's Chief Financial Officer.

Thanks, Mike. NeuroPACE's revenue for the first quarter of 2022 was $11.4 million compared to $11.2 million for the first quarter of 2021. Growth in the quarter was primarily driven by an increase in unit sales of our RNS system to comprehensive epilepsy centers for initial implant procedures. In the first quarter, Revenue from initial implants was $8.8 million compared to $8.1 million for the first quarter of 2021. Growth in the quarter was driven primarily by an increase in the number of initial implant procedures, despite headwinds from the Omicron variant in the first half of the quarter. Revenue from replacement implants was $2.6 million compared to $3.1 million in the first quarter of 2021. We continue to expect replacement in plant revenue generally to decrease for the next several years due to the transition to the current model of our device, which has a longer lasting battery. Gross margin for the first quarter of 2022 was 73% compared to 76% in the first quarter of 2021. The decline in gross margin relative to the prior year period was primarily due to an increase in indirect labor costs resulting from stock-based compensation and reduced production volume as a result of the increased volatility resulting from the COVID-19 pandemic. Total operating expenses in the first quarter of 2022 were $18 million, compared with $12.4 million in the same period of the prior year. R&D expense in the first quarter of 2022 was $5.6 million compared with $4.1 million in the same period of 2021. The increase in R&D expense was primarily driven by an increase in personnel, product development, and clinical study expenses. SG&A expense in the first quarter of 2022 was $12.4 million compared with $8.3 million in prior year period. The increase in SG&A was primarily driven by increased costs associated with operating as a public company, personnel-related expenses, and increased sales and marketing costs to support commercial expansion initiatives. Loss from operations was $9.8 million in the first quarter of 2022 compared to $3.9 million in the prior year period. We recorded $1.8 million in interest expense in the first quarter was flat compared to the prior year period. Net loss was $11.5 million for the first quarter of 2022 compared to $8.8 million in the first quarter of 2021. Our cash and short-term investments balance as of March 31, 2022, was $103.2 million, while our long-term borrowings totaled $50.1 million. Now, turning to our outlook for 2022. We continue to expect annual revenue between $45 and $48 million. This assumes initial implant revenue between $39 and $42 million. Because the operating environment has improved over the last 60 days, we expect initial implant revenue to normalize in the second half of 2022 as the pipeline of new patients continues to build and they transition through the six-month diagnostic evaluation process. We continue to expect 2022 replacement revenue to be approximately $6 million. Moving down the income statement, we continue to expect gross margin to be in the mid-70% range and operating expenses between $74 and $76 million, of which approximately $8 to $9 million is non-cash stock-based compensation expense. This concludes our prepared remarks. I would like to turn the call back over to the operator, who will open the call for questions.

As a reminder, if you'd like to ask a question, please press star then 1. If your question has been answered and you'd like to remove yourself from the queue, press the pound key. Our first question comes from Robbie Marcus with JPMorgan. Your line is open.

Hi. This is actually Rohan for Robbie. Thanks for taking the question and congratulations on a good quarter. To start, would you be able to give us some more color on revenue cadence for the year The first quarter came in a little higher than expectations due to a better recovery in February. So how do you view current guidance in light of this? Also, does the range contemplate any further COVID variability? And then I have a follow-up question.

Very good, Rohan. Thanks for the question. So let me start off with just a general comment and the observation that you made. We're very Pleased with the way that we started the year with being able to recover from the challenges at the beginning of the quarter due to the Omicron variant. As we think about the guidance for the year, we've reiterated the $45 to $48 million guidance that we provided in the earnings call a few months ago. Really, the rationale for that is that we're continuing to execute on the core commercial strategies, increasing the number of centers that are implanting, increasing utilization. We anticipate that through the year we'll continue to drive increases in both utilization and number of centers and planning, resulting in implant revenue from initial system implants continuing to increase through the year. And then counterbalancing that, we expect that the replacement implant revenue, as anticipated, will continue to decrease through the year, resulting in that total amount. We did have the near-term, short-term dynamics that were happening in Q1 with the delays and procedures that happened in the early part of the quarter. We were very pleased at the speed at which we were able to recover those delayed cases in the second half of Q1 and anticipate that there's going to be some impact of the number of patients coming through the epilepsy monitoring units in Q1 having an impact on Q2. with the recovery happening there faster than we anticipated when we provided an update a few months ago. But the trends that we're seeing overall in the epilepsy monitoring units are positive. We're seeing that those volumes of patients coming through the EMU have increased over the last couple of months compared to the decreased levels that we saw at the beginning of Q1. And overall, the backlog of patients that we're hearing from our customers at the epilepsy monitoring units has continued to grow, and we're anticipating that those numbers of patients coming through will continue to increase through the course of the year, providing an opportunity for us to be able to grow the business in addition to the efforts that we're doing on the commercial side. So just in general, we're seeing that the second half of the year is going to be continuing to grow in initial implant revenue, allowing us to get to the guidance that we provided for the year overall.

Okay, great. And would you be able to comment on how much of a headwind staffing is in the EMU relative to lower patient volumes due to COVID, at least in the first quarter and what you're seeing with staffing moving forward? Are you seeing kind of like higher utilization levels offsetting this with more doctors implanting a greater share of patients alongside the new center additions? Just want to get your thoughts on that dynamic. Thanks.

The dynamic that happened in the first quarter with Omicron was different than what we saw in the previous waves of the pandemic, where previously the Delta variant and some of the other variants were more causing epilepsy centers, causing hospital administration to say that they weren't going to be doing elective procedures because of concerns about the hospitals filling up, ICU capacity. Really what we saw from the Omicron variant was a much larger number of people being infected. That included staff at the hospitals, which limited the ability of the centers to treat patients, to schedule procedures, to bring them through the diagnostic process. That exacerbated staffing challenges. So we've talked previously about hospital staffing in particular, the nurse staffing and the technician staffing. the Omicron and the number of people that were infected made that even worse in the first half of the quarter. We know that the hospitals are continuing to try to build up their capacity in terms of the staffing. That continues to be a factor. And when we look at the number of patients coming through the epilepsy monitoring unit now, meaning the last couple of months, that has primarily been a factor of staffing and then just increasing patient confidence of coming into the hospitals. We expect that's a longer-term trend where the hospitals are trying to increase those staffing levels. And we know that they're working to do that. But that's definitely been a key reason why in 2021 and the start of 2022, we haven't gotten epilepsy monitoring unit volumes yet back to the levels that they were pre-pandemic. Okay, great.

Thank you so much.

Our next question comes from Larry Beagleson with Wells Fargo. Your line is open.

Hey, good afternoon, guys. Thanks for taking the question and congrats on a nice quarter here. Mike, just maybe to put a finer point on one of the prior questions, are you signaling because of the pipeline here within EMUs that Q2 is going to be for initial implants is going to be flat or down sequentially? I think it was pretty clear earlier that you expect replacement to kind of continue to decline through this year. But on initial implants, I wasn't sure what you were signaling for Q2.

We didn't provide specific Q2 guidance. We reiterated the full-year guidance. And coming off of Q1, when we came in ahead of the guidance that we provided for Q1, Part of the reason for coming in ahead of the guidance we provided in Q1 was that the patients that we knew were delayed at the beginning of the quarter, the recovery of those patients or the scheduling and completion of the implant of those patients happened faster than what we had anticipated that they would. So we were very pleased at the recovery and overall the growth that we were able to demonstrate in the first quarter. The result of that is that those patients did get, the delayed patients did get implanted in Q1, and we're feeling the impact of the patients coming through, the fewer patients that came through the EMU at the first part of the quarter. So not providing specific numbers for Q2, but just thinking about the dynamics that are happening in the near term, we are having some effect of the EMU process in the first quarter impacting the specifically the start to the second quarter, and then seeing that normalized here through the last couple of months, which continues to give confidence in the ability to grow the business in the second half of the year.

Okay. And just switching gears on the market expansion studies, so Nautilus and the adolescent study, can you remind us again, please, of how long you think those will take to enroll so we just can kind of think through kind of approval timelines?

We haven't provided specific enrollment time guidance. So I'll remind you of the key factors that are involved with that. So the Nautilus study, which is our top priority for expanded indication, we're expecting to start enrollment in that study around the middle of this year. We know that we need to enroll about 100 patients. to be able to implant over 80 patients in that trial. We know that it's a one-year follow-up study for the indication and then a PMA submission or PMA supplement submission that happens on the other side of that. So the time to enroll those 100 patients in the trial, we haven't provided that information yet. We'll give more clarity on that as we are able to get enrolling and understand how many sites are able to get up and running to be able to complete that. So the start of enrollment, again, around the middle of this year, about 100 patients that we need to enroll and then a one-year follow-up for the primary endpoint. The response study, the adolescent study, is very similar to that, so a little bit smaller number of patients, so kind of 75 patients that need to be implanted at a minimum for that study, but similar kind of magnitude, one-year follow-up for the primary endpoint of that study as well. So I would say overall kind of similar number similar size studies, similar amount of follow-up, and then PMA supplement submission for both of those.

Are there any precedents, Mike, that you can point us to on how long it would take to enroll 100 patients and implant 80?

So I don't have any specific precedents for the amount of time that it's going to take to enroll. I will reiterate that our focus is is primarily on the Nautilus study. So as an organization, that's where we're putting the majority of our effort. It represents the largest market opportunity in terms of the number of patients and a new opportunity to expand into an area that we're quite excited about. So internally, we're focused primarily on the Nautilus study and moving into generalized epilepsy. Again, we'll provide more clarity as we get into the enrollment in the study and understand the number of centers, but I don't have a specific comparison to be able to point you to. All right. Thanks so much.

Our next question comes from Michael Pollack with Wolf Research. Your line is open.

Hey, good evening. Good afternoon. Thank you for taking the questions. First one, gross margin sounded like some non-cash comp, lower overhead absorption in the quarter, but I also heard COVID volatility, and it wasn't clear if that was just, hey, look, volumes have been disrupted in the trailing six to 12 months, and so you've been turning down production, and so there's the leverage, or if that was a comment on supply chain and sourcing and componentry and input costs going up. So any additional color on the cost of goods here and what influenced gross margin in the quarter would be helpful.

Sure, I'll take that. Thanks, Mike. So our gross margin in the first quarter was 73%. That's consistent with our gross margin in the fourth quarter. And currently that's our baseline. There's nothing really unusual in the first quarter. We did have some increase in cost related to SBC. And we had some lower absorption. Volatility in demand led to volatility in production and then lower production overall. But we're not seeing supply chain disruption. We have purchased some components and materials earlier than we might otherwise to mitigate any potential risk that could develop in the future, but we're not seeing supply chain disruption. So really, it's just the factors that we mentioned, nothing really unusual that stands out for the quarter.

And then a follow-up just on the commercial investments. It sounds like it's on track, but I'd be curious to get an update on your progress in terms of hiring and forming some new territories, bringing new centers online. I mean, it's a difficult environment, 1Q, especially difficult for providers. How has that played out so far this year? And any strains or successes in ramping the commercial org to call out? Thank you so much for taking the questions.

Thanks, Mike. We're quite pleased with the progress that we've been able to make here over the first part of the year in the commercial initiatives. So just as a reminder, there's two primary areas where we're making an investment in the organization, in the commercial part of the organization. One of those is an acceleration of the expansion of our field team. We're targeting to get to around 56 people in the field organization by the end of the year. That's a net increase of on the order of 14 people compared to where we were back at the time of the IPO with most of those hires scheduled to be happening here in the first half of 2022. And pleased to say that we're well on track for that. So the progress that we've been making at expanding the field team is going per plan with some really great people that we've been able to identify and start them through the training processes. The other key area of initiative is around patient education and patient awareness. And so with that, we have increased the amount of work that we're doing to get information about the RNS system, the benefits of the RNS system out to a broader number of patients that are working their way through the diagnostic process. So to help influence them and help to assist them as they're moving through that process. So we've made some good initiatives there, brought some people into the organization that have expertise in that area and are doing what we would expect to do, what we had expected to do as we ramp up in that area. The other comment that I would make is part of the reason that we've expanded or accelerated the hiring of the field team is that it allows us to continue to grow the number of centers that are implanting the device As we have in the past, you can expect that we continue to do that here in 2022. It also enables us to go out to a larger number of epilepsy specialists that are practicing outside of the Level 4 centers. That's been a trend in recent years that there's more epilepsy specialists that are setting up practices outside of these Level 4 CECs, and the larger field organization will allow us to call on those. So they're treating a large number of drug-resistant epilepsy patients. I'm working with them to create a referral dynamic into a comprehensive epilepsy center for the implantation of our device of the RNS system and then having those patients go back to the epilepsy specialists in the community for their ongoing care. And so that accelerated hiring is a key part of that strategy of expanding the number of epilepsy specialists that we're calling on.

Our next question comes from Danielle Antelassi with SDV Securities. Your line is open.

Hey, good afternoon, everyone. Thanks so much for taking the question, and congrats on a great start to the year. I guess, and you kind of already addressed this, Mike, but just a quick question for you on the guidance and why, you know, you did put up a pretty decent top line here. beat in the quarter relative to us, both on initial implants and, well, I guess just on initial implants. And so just curious about why not take the guidance up. Is that just conservatism, or do you anticipate something transpiring a little bit differently for the rest of the year than maybe you had thought back in, what was it, March or whatever when you provided the guidance?

So thanks, Danielle. The guidance for the year, as we've talked about reiterating the guidance for the year, we are coming off of a first quarter that we feel very good about. And, again, part of that is that we recovered the patients that were delayed out of the first part of the quarter rather quickly, faster than we anticipated that we would. So we had anticipated that we would recover those patients in the guidance that we provided. The timing of it, you know, happened a little bit faster than what we had anticipated, which contributed to the B in Q1. And so with that, just wanting to keep the guidance where it is, knowing that the remainder of the year is really being driven by new patients that are coming through the process and our ability to turn those into RNS system implants. And so there's some timing effect and then, you know, really feeling overall like, the trend that we expect it to be on is where we continue to be operating to.

Okay. That's totally fair. And then just as we think about going beyond the level four centers, and I know it's very early in this, but I guess as we think about the investment there and building out the sales force, et cetera, et cetera, when should we think about that really starting to contribute to top line growth and getting patients through the system? And I guess, Is there an opportunity as well? Sorry, this is like a two-part question. So that's the first part. And then the second part, is there an opportunity to shorten the timeline from a patient sort of getting to, I guess, for a patient getting through the process to getting an implant? Or is six months like what it's always going to be and we just have to, you know, that just is what it is? Thanks so much.

Thanks, Danielle. So the investment that we're making in the commercial organization, both the accelerating the hiring of the field organization as well as the patient education awareness initiatives that we've undertaken, those are investments that will pay off over a period of time. If you think about the Salesforce hiring, we hire somebody into the field organization. That allows us to have more call points that we can go out to these referring physicians that provide additional opportunity for us. And then those patients that come out of that go through the epilepsy monitoring unit and the process for the workup and increasing the numbers that come out of that. So overall, if you think about 2022, the guidance that we provided for 2022 is really based on the execution of the strategy within the CECs. It's about getting more of those centers to be prescribing more utilization from those centers. The initiatives that we're doing to expand the field organization and to move outside of the level four CECs to additional epilepsy specialists, those are really opportunities that will benefit the organization beyond 2022. In terms of your question about the six months on average that it takes to get through the epilepsy monitoring unit from initial EMU admission to implantation of the RNS device, We are working to influence that where we can, the process of more connection earlier to patients that are working their way through that process. Where we can do that, we can help facilitate for those patients moving through the steps that they need to go through. So there's some potential that we could, with those initiatives specifically for those patients that we can contact earlier, be able to help them navigate through the system more quickly. That said, much of the process at the EMU is driven by the procedures of the hospital and also the capacity that the institution has. So there's, I would say, some opportunity around that, and we're definitely pushing on those areas where we can push on those areas. But I don't anticipate that there's a dramatic movement in the amount of time it takes patients to get through the EMU process.

Okay. Thank you.

Our last question comes from Drew Ranieri with Morgan Stanley. Your line is open.

Hi, Mike and Rebecca. Thanks for taking the questions. Just maybe to start, I can appreciate that the first quarter there's still some challenges with the EMU capacity and staffing shortages there. Just as you're going through the year into the back half, I just want to make sure that I'm clear here. Are you saying that EMU visits normalized at 2021 levels, or are they normalizing to pre-pandemic levels? And just as you're looking even further ahead into 2023, if you were to stay at 2021 EMU levels, would you be able to accelerate growth next year in new patient implants, just given some of the initiatives that you have in place with the Salesforce and some of the other training initiatives?

Great. Thanks for the question, Drew. And I appreciate the complexity of this as there's trends on top of trends, and so it has the potential to be confusing. So in Q1, in the first half of Q1, we saw that the number of patients coming through the epilepsy monitoring unit, in particular the EMU visits that are part of that process, was decreased relative to 2021, so relative to pandemic levels, if you will. Starting in March, we saw those EMU numbers recover back or move back to or at least close to the numbers that we saw in 2021. So we're now operating and getting around to the levels that I would call pandemic normal, 2021 kind of levels, with anticipation that over time, given improving environment around COVID, which is an uncertainty, but over time, that we anticipate those numbers could get back to the pre-pandemic levels. That's a future statement, not where the EMUs are today. We do know from talking to our customers that they're telling us that there's a backlog of patients that they have looking to get into the EMUs, and so there's potential there. There's demand, if you will, from the patient side. to be able to increase those numbers, but there's a number of factors that have to go into getting back to pre-pandemic levels and then growing from there. As we think about 2023, and again, for 2022, our growth in 2022 isn't anticipating that a return to pre-pandemic levels of EMU visits would impact our numbers in 2022, given the time it takes for those patients to get through the process. So that return to pre-pandemic levels is more of a longer-term growth accelerator for the organization. Part of the reason that we've made the investments that we have made in the commercial part of the organization is to have influence to accelerate growth in areas that we can't control. So looking at calling on more epilepsy specialists outside of the level four centers, tapping into that group of drug-resistant epilepsy patients that they're treating to be able to facilitate their workup through the process, getting more awareness at the patient level earlier in the process. All of those are initiatives that we believe benefit our organization and the growth of our organization independent of the number of patients coming through the EMUs. And the growth of the EMUs, you know, provides an additional opportunity with us. So they're the reason we're making those investments is to be able to control those aspects of growth that we have the ability to influence or we believe we have the ability to influence.

I appreciate the answer. Maybe just to Rebecca, I get that you've purchased more components to make sure there's a steady state of supply. Just as you're kind of looking at the inflationary environment, just how are you thinking about pricing for for your devices, whether on the new patient implant side or replacement side, especially considering I think the DRG code is going up by like 3% for 2023. Just any comment would be great. Thank you.

Sure. So as we've discussed previously, we are in the process of implementing a price increase. in the low single digits this year. That price increase will take place over the course of the year. We don't expect it will have a big impact this year. It will have more of an impact in 2023. But, you know, we are doing that on the pricing side. And, of course, we are cognizant of price pressures in the marketplace. and where we are aware of price increases, factoring that into our planning. So I hope that addresses your question.

It does. Thank you.

Thank you. If there are no further questions, I'd like to turn the call back over to Mike Savitz for the closing remarks.

All right, thank you, everybody. I appreciate your time today and look forward to following up with you in the coming months.

This concludes the program. You may now disconnect. Everyone, have a great day.