LivaNova PLC

Good day, ladies and gentlemen, and welcome to the LevaNova PLC first quarter of 2023 earnings conference call. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star followed by one on your telephone keypad. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's call, Mr. Matthew Dodds, LevaNova's Senior Vice President of Corporate Development. Please go ahead, sir.

Thank you, Bailey, and welcome to our conference call and webcast discussing Leva Nova's financial results for the first quarter of 2023. Joining me on today's call are Bill Cozy, our Chair of the Board of Directors and Interim Chief Executive Officer, Alex Schwarzberg, our Chief Financial Officer, and Brianna Gotland, Director of Investor Relations. Before we begin, I would like to remind you that the discussions during this call will include forward-looking statements. Factors that could cause actual results to differ materially are discussed in the company's most recent filings and documents furnished to the SEC, including today's press release that is available on our website. We do not undertake to update any forward-looking statement. Also, the discussions will include certain non-GAAP financial measures with respect to our performance, including but not limited to sales results, which will all be stated on a constant currency basis. reconciliations to the most directly comparable GAAP financial measures can be found in today's press release, which is available on our website. We have also posted an earnings update to our website that summarizes the points of today's call. This update is complementary to the other call materials and should be used as an enhanced communication tool. You can find the update and press release in the investor section of our website under news events and presentations at investor.livanova.com. Now, it is my pleasure to introduce you to Bill Cozy. Bill joined Livanova's Board of Directors in 2018 after the conclusion of his 42-year career at Beck & Dickinson, where he retired as Executive Vice President and Chief Operating Officer in 2016. At BD, he served as a member of the corporate leadership team and held various executive roles since 1988. As a result, he brings expertise in strategy execution, operations, and financial discipline. With that, I will turn the call over to Bill.

Thank you, Matt, and thank you everyone for joining us. It is my pleasure and privilege to welcome you to Levanova's conference call for the first quarter of 2023 as Levanova's Chair and Interim Chief Executive Officer. First and foremost, on behalf of the board and the executive leadership team, I'd like to express our gratitude to Damian McDonald for his dedicated leadership and countless contributions to the company over the last seven years. We wish him all the best in his future endeavors. In this interim role, my focus is firmly on patience, performance, and execution. In the coming weeks, I'll continue to engage with our global customers and colleagues as well as the investor and analyst communities. Even though I'm new and learning, I'm already working alongside our experienced executive leadership team and the board, and I do remain confident that we'll facilitate a smooth and positive transition as we search for Libanova's next leader. For the remainder of the call, I'll discuss our first quarter results and then turn to our strategic portfolio initiatives. After my comments, Alex will provide additional details on the results and increases to 2023 guidance. I'll wrap up with closing remarks before moving on to Q&A. In the quarter, we achieved 13% revenue growth marked by strength in the cardiopulmonary and neuromodulation businesses, while advanced circulatory support remained unfavorably impacted by a decline in severe COVID cases. We were particularly pleased with the way the rest of world and Europe regions drove results especially in emerging markets. Worth noting, these regions comprise 47% of total company revenue in the quarter, up from 43% in the prior year period. Now, turning to segment results. For the cardiopulmonary segment, revenue was $132 million in the quarter, an increase of 18% versus the first quarter of 2022. Oxygenator revenue grew in the high teens, driven by higher demand and improving supply chain performance. Heart-lung machine revenue increased in the low double digits, driven by new installations and replacements in the rest of the world and Europe regions. As a reminder, our Essence heart-lung machine received U.S. FDA 510 clearance in March and approvals from Health Canada and the Japanese PMDA also during that first quarter. Additionally, we initiated a broad commercial release in Europe. We now expect cardiopulmonary revenue to grow 5 to 7% for full year 2023. Our revised forecast includes more clarity around the rollout of essence based on recent approvals. In addition, our revision now incorporates the strong first quarter performance in oxygenators. Alex will comment on some underlying factors that impacted the first quarter result in cardiopulmonary. Epilepsy revenues increased 11% versus the first quarter of 2022, with strength across all three regions, including growth in both new and replacement implants. U.S. epilepsy revenue increased 8% year over year, driven by growth in total implants, higher realized price, and product mix. In the U.S., we are continuing to emphasize our commercial strategy in comprehensive epilepsy centers. As many of you know, these CECs currently do the majority of surgical epilepsy procedures, and our focus on engaging with KOLs at these sites remains a top priority. Epilepsy revenue in Europe grew 14% versus prior year led by the U.K. The rest of world region achieved 30% growth led by Brazil. For the full year 2023, we continue to expect global epilepsy revenue to grow three to 5% as we take a fresh look at the factors driving new patient surgical penetration. I will be spending a notable amount of time with our key customers and KOLs. And again, Alex will comment on some underlying factors that impacted that strong first quarter result in epilepsy. ACS revenue was $10 million in the quarter, representing a decrease of 16% from the first quarter of 2022. Results continued to be impacted by the year-over-year reduction in severe COVID cases and in part by product mix, partially offset by growth in non-COVID cases. Our field data suggests ACS case volumes related to COVID declined approximately 90% year over year as fewer hospitalized patients progressed to a severity that required ECMO therapy. However, that field data also suggests ACS non-COVID case volumes increased versus the first quarter of 2022, driven by the easing of hospital capacity constraints and account acquisition. For 2023, we continue to expect ACS to grow 4% to 6% with the majority of the growth in the back half of the year. As a reminder, this is the last quarter this business will be significantly impacted by COVID comparisons. Turning now to the strategic portfolio initiatives. DTD revenue in the first quarter was $2 million. For 2023, we now anticipate DTD revenue of approximately $8 million, primarily from the RECOVER study. The RECOVER study continues to advance. In March, the interim analysis for the 475th patient in the unipolar cohort was completed and confirmed the study's continuation. Subsequently, we randomized the 500th unipolar patient into the trial. Upon receipt of the 12-month follow-up data for the 500 unipolar patients, we will conduct a final analysis and expect the publication of the study results by late 2024. Now that enrollment in the unipolar cohort is complete, our recruitment efforts have been refocused on the bipolar cohort. We expect to reach 150 bipolar patient implants in late third quarter or early fourth quarter. By now, I'm sure you've familiarized yourself with the RECOVER study. I recently met with two of the study's principal investigators, Dr. John Rush and Dr. Charles Conway. These conversations reflect the continued excitement from the KOL community, and I hope you appreciate the company's total commitment to finish this initiative. Moving now to OSA, The Osprey trial continues to progress with 24 study sites actively recruiting patients. Similar to my comments on DTD, myself, the board, and our project team remain committed to this project as well. In heart failure, the closeout of the Anthem clinical study is in progress. We have fully defined most of the accelerated costs in 2023, part of which occurred in the first quarter. Therefore, our expectation is that the overall R&D spend related to heart failure this year will be approximately $24 million. With that summary, I'll turn the call over to Alex.

Thanks, Bill. During my portion of the call, I'll share a brief recap of the first quarter results and provide commentary on 2023 guidance. Turning to results, revenue in the quarter was $263 million, an increase of 13% versus 2022. In the quarter, we saw a strong oxygenator demand, better than expected replacement implants, and some accelerated orders. Additionally, we were able to continue to drive strong realized price from actions taken in the second half of 2022. Foreign exchange in the quarter had an unfavorable year-over-year impact of approximately $7 million, or 3% of revenue. Adjusted gross margin as a percent of net revenue was 69% compared to 71% in the first quarter of 2022. Adjusted gross margin was unfavorably impacted by inflationary pressures, geographic and product mix, partially offset by pricing improvements. Adjusted R&D expense in the first quarter was $46 million, compared to $40 million in the first quarter of 2022. R&D as a percent of net revenue was 18% versus 17% in the first quarter of 2022. The year-over-year increase was driven by continued investments and strategic portfolio initiatives and the costs associated with closing out the Antintrub. Adjusted SG&A expense for the first quarter was $108 million, compared to $102 million in the first quarter of 2022. SG&A as a percent of net revenue was 41%, down from 43% in the first quarter of 2022. The year-over-year increase on a dollar basis was driven by higher sales and marketing expenses. These include Essence launch expenses, and variable costs associated with increased revenues. Adjusted operating income was $27 million compared to $28 million in the first quarter of last year. Adjusted operating income margin was 10% compared to 12% in the first quarter of 2022. Adjusted operating income was negatively impacted by, one, product and geographic mix, two, incremental investments in the OSA and DTD programs, as well as accelerated spend related to the closeout of the heart failure program. And three, commercial investments focused on the Essence launch. These key elements negatively impacted adjusted operating income margin by 300 basis points versus the prior year. Adjusted effective tax rate in the quarter was 6% versus 7% in the first quarter of 2022. Adjusted diluted earnings per share was 43 cents compared to 48 cents in the first quarter of 2022. Our cash balance at March 31st was $214 million, in line with $214 million at year end 2022. Total debt at March 31st was $542 million, in line with $542 million at year end 2022. Net debt, including restricted cash, at March 31st was $72 million. Adjusted free cash flow for the quarter was $20 million, up from $17 million in the prior year. Free cash flow generation was improved by working capital management. Capital investments were $8 million in the first quarter compared to $5 million in the prior year quarter. Now turning, to our revised 2023 guidance. As Bill mentioned, based on our performance during the first quarter, we are increasing our full year 2023 revenue and earnings per share guidance. We now expect 2023 revenue growth on a constant currency basis between 4 and 6% and continue to assume approximately a 1% tailwind from exchange rates. We now expect adjusted diluted earnings per share in the range of $2.50 and $2.70, with adjusted diluted weighted average shares outstanding to be $54 million for the full year. Adjusted free cash flow is still expected to be in the range of $80 to $100 million. In summary, I'm encouraged by the first quarter top line performance, and we remain positioned to drive operating leverage by year end. With that, I'll turn the call back over to Bill.

Hey, thank you, Alex. Libanova's first quarter performance demonstrated continued progress across the portfolio and positions the company well to deliver on its pipeline and its full year guidance. We're eager to build upon the first quarter results with a firm focus on patience, performance, and execution throughout the remainder of 2023. In closing, we're committed to our DTD and OSA programs. And let me be equally clear, we're also focused on accelerating new patient penetration in U.S. epilepsy, continuing strong performance in the rest of world and Europe regions, and of course, driving the successful launch of Essence. Our employees remain dedicated to helping patients worldwide and are focused on long-term innovation and shareholder value creation. And by the way, I thank them for the welcome they have extended to me over the last couple weeks. With that, Bailey, we're ready to open the call for questions.

Thank you. If you have a question at this time, please press the star, then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press star followed by two. As we enter the Q&A session, please limit yourself to one question and one follow-up question. and then return to the queue if you have additional follow-ups. The first question today comes from the line of Rick Weiss from Stifel. Please go ahead. Your line is now open.

Good morning, everybody. Good morning, Bill. Good to hear your voice again. Good morning, Rick. Thanks. Thanks. It was great to hear you spell it in such clarity, some of your priorities. patient's performance execution, and I appreciate the summary at the end. But maybe just for, you know, those who maybe know you less well than I do, maybe talk in a little more detail about your priorities during this, how you're going to go about driving these things during this interim period. You know, do you, How active a role do you expect to play? And maybe taking those, the NPI build, the focus on the rest of the world and the essence launch, I mean, how will your typically hands-on detailed approach help drive that forward? Thank you, Bill.

Hey, Rick. Thank you. Thank you for the question. I've talked a lot with all of the colleagues here at Levanova, and the interim role is, as you already know, is something to be thought through. But the way I've thought through it goes as follows. As I mentioned earlier, attention on patients' performance and execution. And that's from my personal perspective, that's head down and all in. So I would challenge myself to operate in this interim role just the same as I was used to operating and my prior roles, the board had requested this as we made this transition. The organization has been just terrific in the way that we're starting to collaborate. But I'd reiterate the four initial takeaways from the first couple weeks. And the way I just closed, we're really committed to the SPIs. We're really going to look closely at epilepsy and what can we further do to improve our performance in surgical penetration. We're gonna look at how can we take best advantage of this already strong performance that we're seeing in the regions. My comment about 47% of revenue in those areas, it's notable and it's a really good signal about how the company's progressing when you think about the year-on-year success. And then Essence also at the top of the list, as I mentioned. Just to circle back, I want to make sure I've left it clear with you that interim refers to the time frame that I will be here. It in no way refers to my commitment to the business or doing everything I can to work with this executive team and to effectively make better the performance of the company as we seek the next leader.

That's a great answer, Bill, and thank you for that. I'm going to ask one and a half follow-ups. One, the first is on the guide, to what extent is the 2023 guide thoughtfully conservative, maybe as usual, or is it extra conservative given this transition period? And maybe you could talk to us at a high level again How do you see, how is the board thinking about the search for the next leader? Is it inside the company, outside? What are your priorities? What are you looking for? What characteristics as you pursue this search? Thanks, Bill.

Thanks, Rick. That one and a half sure sounded like two, but let me take a shot at it. So Alex did a nice job of sharing with you kind of the drivers behind the 13% growth in that quarter. What I think is prudent, and it even becomes more prudent at the start of the year, you just make sure you've got some understanding of underlying factors. And there are definitely a couple. I mean, even the new guy caught a couple things in the P&L that said, this looks a little bit favorable. I'll throw you an example. I said, geez, I don't think we want to count on Russia, okay, each and every quarter. And to extend that out is just one example. So Alex has got a full handle on that, and you know what, I'll have him in a second add a little color to that, but I'd like to think that we're being prudent, and particularly at this stage of the year. Now to your second question there, the board has really done a thorough job in their specificity about the next CEO, and I would not drag you through what actually is a pretty thorough job spec for the next CEO. Let me hit the 100,000 foot level. The nature of this business is that great strategic capability is meaningful. And that would certainly gonna be at the top of the list. What I guess the real secondary expectation though for us is to link that ability to look longer term but to align that thinking with really favorable operating acumen and the ability to link those two things to continually improving financial outcomes. It sounds pretty, I guess, pretty obvious, but that's really at the top of our list at that 100,000 foot level. Things like cost discipline and things like operational excellence, they are going to be just as important as trying to find that person who is really talented at looking around the corner. And particularly with, you know, these set of platforms, particularly think about SPI, okay? Those two things really become essential to ensuring the success of the company, you know, if and when those SPIs should appear. I hope that gives you a little bit of a sense.

Thanks. Appreciate it.

Alex, anything to add on my prudent comments about the guide?

As you said, Bill, you know, we're looking at the underlying market dynamics and how that really translates into growth for the remainder of the year. As I mentioned, we saw a strong oxygenator demand. We saw better than expected replacement implants in epilepsy. And we also saw some accelerated orders into the quarter, so kind of a phasing thing. And we just want to make sure that all of these parts are sustainable. And that was the rationale for our guide.

Thanks again. Thank you. The next question today comes from the line of Michael Pollack from Wolf Research. Please go ahead. Your line is now open.

Hi, good morning. Thank you for taking the questions. I have two, one on the leadership transition and one on depression. Um, Bill, I'm curious for your perspective on this. You know, we get this question when, um, things like this happen, you know, why now, you know, Damien's transition, um, obviously a few weeks ago, it was kind of a straightforward question to answer with the revenue pre-announced. It wasn't about the quarter, but, um, you know, how do you see this? And, um, You know, is there anything in here that, you know, the street needs to be concerned about? Or, you know, is it, to your other comment, you know, head down and execute? And no, there's nothing else here. So any color there would be helpful.

Yeah, thanks for the question. As we did try and talk about earlier, I mean, Damien resigned, and we certainly appreciate his leadership and and the things he did for the company. There was no new job that was announced. There were no personal issues reflected. There was a very constructive commitment to help the company in the transition window throughout the month of May. And all those things are right on the rails. So at this point in time, that's the understanding of everything that happened. It's that simple. I don't have any story to add.

Understood. On depression, just like a reminder for the unipolar cohort, the 500th patient is in. The premise now is follow for the full 12 months, and then we'll see what we see. I guess, can you remind us, at the 475th patient interim analysis, you know, these rolling interims tested for, you know, early futility and early success. And I think there are some criteria as to what kind of futility might have looked like at 475 and what early success might have looked like at 475 in terms of separation VNS versus control. So, would you be willing to frame up those parameters like, you know, you were above this, you were below this, and you're somewhere in the middle, and so you're continuing, and then the follow-up there is like, what is required at 500 fully followed in terms of separation to be statistically significant at the end of this? So any color there would be great. Thank you so much.

Yeah, thanks for the question. Here I am in day 19, so I'm going to flip this right over to Matt, okay? who really is a much better source of information.

Thanks, Bill. And hi, Mike. So for your questions, at 475, the potential to stop enrolling early, the upper bound, that was around 80%. And then the futility, it got only up to 45%. So it's somewhere in between there. There is no look at 500. So we are going full 12-month enrollment with all patients, which That goes out to mid-2024. Again, the study was always designed for 500 patients in both arms, unipolar and bipolar. And to your specific question, you know, primary endpoint is time and response, it's somewhere in the low 60% range to hit the p-value of 0.023. Thank you. Sure.

Thanks, Mike. Thank you. The next question today comes from the line of Matt Taylor from Jefferies. Please go ahead. Your line is now open.

Hey, good morning. Thank you for taking the question. Excuse me, I'm sorry. I was hoping that you could talk a little bit more about the epilepsy trends, both the overperformance and replacements, where did that come from, and then the focus on new patients. And I know in speaking with Matt maybe a month ago or so, he was telling me about some interesting things you're doing with the incentives and the sales force. I'd love if you could touch on that.

Yeah, let me ask Matt to go first, but then I do want to add some comments.

All right. So, Matt, I'll start with EOS, then I'll turn it over to Bill for NPI, and then we can flip back on some of the things we've recently done. So for EOS, we still believe we're largely through the COVID-related backlog. Again, not perfect math, but that's our thinking. Also remember that first quarter was the lowest comp of the year in 2022. So we did have an easier comp this quarter. Now, all that said, we did put some programs in place late last year to help identify patients lost the follow-up, and we think we might be seeing some early success there, but again, it's early. So that's what really drove the EOS. I'll turn over to Bill for some comments on NPI, then I'll talk a little bit about some of the things we've been looking at on the Salesforce.

Yeah, but by way of background, I think some of you might recall that some of the previous calls we've referenced the really important efforts to make sure that we've got our sales organization appropriately targeted, resourced, and capable of really dealing with the KOLs in these comprehensive epilepsy centers. And that continues, and I believe in a very constructive way. Admittedly, the volume's up there, but it's being done in a very constructive approach to our customers. And then the second thing that, as a senior management team, we've all had a chance to chat here over the last couple weeks. This is a very high priority strategic parameter for all of us. So I'll be out next week, first time I've had a chance, but I'll start, you've heard me reference maybe a few times, my commitment to getting out. I'll be out next week for a couple of days. I'll follow that up frequently, making sure that we have increasing depth of understanding of A, the customer, B, the surgical penetration expectations, And C, of course, most importantly, what else should we be doing to arm our sales rep with better information and capability?

And then as your follow-up, we did mention last quarter that we did make some changes to the U.S. epilepsy sales force late last year and then early into this year. A lot of involuntary change. In general, we had about 20 changes. People change positions, and what we were highlighting was the quality has been very high for the replacements we've had of the 2012 have direct neuromodulation experience. Others are in areas like diabetes and neurosurgery, so very encouraging. In early days, some of these new hires have made already a nice contribution to the overall performance.

Great. Thanks, guys. Very thorough. I appreciate it.

Thank you. The next question today comes from the line of Adam Maeder from Piper Sandler. Please go ahead. Your line is now open.

Hi. Good morning, everyone. Thanks for taking the questions, and congrats on a solid start to the year. Wanted to start on the CP business and just get a little bit more color there it looks like the performance was really driven ous while us was a little bit softer are you able to just kind of flesh out those uh trends by region for us it's perhaps just simply uh driven by essence and timing there but any thoughts would be helpful and then can you also just remind us um how you're pricing essence i think it's uh being priced at a premium but would love to get some color there as well and i had a follow-up or two thanks

Yeah, Alex and I have had this almost identical conversation. I'm just going to flip it over to him because he's really got his arms around it.

Hey, Adam. So, CP, we saw really solid demand for oxygenators and the heart lung machines. We had some really good placement volumes, OUS. We expect revenue from Essence to start to contribute meaningfully in the second half of the year. So, that was sort of, if you look at the regional breakdown, the U.S. was less positive in the quarter, but that's because customers are deferring orders at this point in time. We just got the clearance in the U.S., and we should start to see volumes ramp in the second half. our solid performance on the consumables businesses is really, we're seeing some of our competitors experiencing supply chain challenges. And frankly, our supply chain is, our team is doing extremely well, and we're able to capture some of the placements. So feeling really strong about what and how the business performed in the first quarter and really looking forward to the remainder of the year. Price. That's helpful color for Alex. Yeah, one other thing in terms of price on Essence. Yes, we've been commenting to a premium price offering. Obviously, the features and benefits of Essence are superior. At the same time, the cost of the The unit itself is higher. So we are going to price Essence at a very reasonable premium that customers will still appreciate.

Great. Thank you for the fulsome response. Maybe switching gears to obstructive sleep apnea, I guess first was hoping to ask, how you're thinking about timelines for that program. I think before you were anticipating FDA approval by year end 2024, wanted to see if that's still the case. And then second, the data from the THN-3 trial were recently published in a medical journal. Just any color or thoughts on that publication. And then just one question that I get sometimes from investors is, you know, just talk about kind of the learnings and any changes to either the, you know, the trial design or the device design with OSPRI relative to that previous study. Thanks.

Sure, Adam. It's Matt. I'll go through all those. So, for OSA, we are, you know, still making progress on, you know, recruitment, implants. We have increased the study sites from 20. We're now at 24. So that's going well. We've incrementally invested on several fronts to drive the recruitment funnel. But remember, this is a randomized trial. Other trials have not been randomized. So there is some drop off in the funnel. We've had a strong funnel of patients, but there is some drop off. So we do expect to complete enrollment now in 2024 and looking at FDA approval now in 2025. And then related to the JAMA publication, our take here was that generally quite positive. It highlighted a lot of what you've already seen in THN-3, especially in the areas of the primary endpoints and how the author felt we did on that. So I think that's the full takeaway from the JAMA publication.

Okay, that's helpful, Matt. And just any flavor for changes to the device itself or trial design? And then, sorry, I have one more follow-up for you guys. Thanks.

Sure. So, no changes to Osprey, the same. In terms of the device, nothing new to report there on the current device. You know, we basically just tightened up a few things on the existing device to make it a bit more reliable.

Okay, got it. Thank you for that. And then just one last one clarification on the cost savings from the heart failure program. I guess it was a little bit unclear to me in the prepared remarks. What is the expectation, you know, for any cost savings this year? Is anything reflected in the updated guidance? Thanks so much for taking the questions.

Yeah, Alex has got this one. Alex, would you please?

Yeah. As we mentioned, the total cost we estimate to be around $24 million for the year. Look, our number one priority here is patient safety. It's a complex, you know, complex implanted device, and I want to make sure that we take patients into account and patient safety into account. Last year, we spent roughly, call it $27 million. So the savings this year are minimal, but we expect to draw significant savings in 2024.

Okay, perfect. Thank you. Thanks, Adam.

Thank you. The next question today comes from the line of Mike Mattson from Needham Company. Please go ahead. Your line is now open.

Yeah, thanks. So, Bill, I think you mentioned that you were planning to exit Russia, so correct me if that's wrong, but can you tell us how much of your revenue is coming from Russia?

You know, that was one of the things that caught my eye. You know what was said, and then in the first quarter, Alex, it was a couple million. I mean, it was notable. I don't have the exact number here in front of me. Alex, do you?

Yeah, I do. It's roughly 1% of our revenue, right, historically. So it wasn't a significant amount, but we're not planning and we're not incorporating those revenues into our guidance. So the ability to serve those customers in the quarter, just not necessarily counting on a repeat order pattern throughout the remainder of the year.

Yeah, we got no reason to treat it anything other than a one-time event at this particular moment.

Okay, got it. And then as far as the, just on the trial spending, so you commented on heart failure in the prior Adam's questions, but... I guess just the sequencing of the $24 million in costs this year, I mean, is that kind of spread evenly throughout the four quarters or will it be more kind of weighted to the first half of the year?

It's going to be phased. We actually accelerated the spending in the first quarter as we, you know, obviously seeing patients come in for their visits and really closing out the you know, the components of the sites. So I think that we'll see an uptick in spend in the first half, and then it should start to ramp down by the end of the year.

Okay, thanks. And then just as far as recover goes, I mean, now that you hit the 500 patient mark, I know you're focused on the bipolar now, but I mean, is it reasonable to assume the spending level there would be lower? for the follow up period or?

No, it's not because we call our focus now shifts to the bipolar cohort. So recruitment of the bipolar patients, obviously continuing to monitor the unipolar patients. So our our spend really does not go down at all this year.

OK, thank you. Thanks, Mike.

Thank you. The next question today comes from the line of Matt Mixick from Barclays. Please go ahead. Your line is now open.

Hi, this is Sarah on for Matt. Thanks for taking our questions. Just a quick follow-up on the recovered study. I believe you said you received final analysis and results by late 2024 instead of maybe earlier with mid-24? Is coverage decision by year-end 24 still the right way to think about this?

Yeah, sure, Sarah. So we're still expecting the date around mid-24. We're now in the 12-month follow-up. There's going to be a couple months of analysis, but we should have it mid-24, and we still expect a publication around year-end of 2024.

Okay. Thank you for that. And then another is, you know, a theme for this quarter we've seen is there seems to be a significant ramp in utilization and volumes across many of our end markets. You know, can you talk about how your businesses participated in this ramp and if they still remain below historical utilization levels? Any comment on that would be helpful.

I can comment to that, Sarah. So, you know, we've seen mark a market recovery. We continue to see a market recovery in volume. So as we think about our sources of growth in the quarter, particularly in the emerging markets, you know, areas like China, where, if you recall, you know, last year, this time, you know, those regions were really going through the Omicron COVID impact, and so we are absolutely seeing that recovery, and that's part of the reason we saw the substantial growth in the quarter. So we said it was an easier comp, if you will, but we feel encouraged by what we're seeing from a customer demand perspective.

And then in epilepsy, we still track on a quarterly basis the epilepsy monitoring unit or, you know, EMU trends, they're still not back to pre-COVID levels. We estimate they're around 85, 86% capacity. And that covers all surgery, not just VNS. But then internationally, you know, our business there is, you know, is well above pre-COVID levels. So that has rebounded quite nicely.

Okay. Thank you.

Thank you, Sarah.

Thank you. There are no additional questions waiting at this time, so I'd like to turn the conference over to Bill Cozy for any closing remarks.

Well, thank you, everyone, for joining today's call. On behalf of the entire team, we appreciate your support and your interest in the company, and we'll look forward to speaking with you soon. Thank you.

This concludes today's conference call. Thank you all for your participation. You may now disconnect your lines.