Q1 2023 LivaNova PLC Earnings Call
Speaker 1: Good day ladies and gentlemen and welcome to the Levenova PRC 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.
Speaker 1: As a reminder, this conference call is being recorded. I would now like to introduce your host for today's call, Mr Matthew Dodds, Levenova's Senior Vice President of Corporate Development. Please go ahead, sir.
Speaker 2: Thank you, Bailey, and welcome to our conference call and webcast discussing Leva Nova's financial results for the first quarter of 2023.
Speaker 2: Joining me on today's call are Bill Cozzi, our Chair of the Board of Directors and Interim Chief Executive Officer, Alex Schwartzberg, our Chief Financial Officer, and Brianna Gotland, Director of Investor Relations.
Speaker 2: Before we begin, I would like to remind you that the discussions during this call will include forward-looking statements.
Speaker 2: 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.
Speaker 2: 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.
Speaker 2: 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.levanova.com.
Speaker 2: Now, it is my pleasure to introduce you to Bill Cosby.
Speaker 2: Bill joined Liva Novus Board of Directors in 2018 after the conclusion of his 42-year career at Beckton Dickinson, where he retired as Executive Vice President and Chief Operating Officer in 2016. At B.D., he served as a member of the Corporate Leadership Team.
Speaker 3: Thank you, Matt, and thank you everyone for joining us. It is my pleasure and privilege to welcome you to Leibin-Ovis Conference call for the first quarter of 2023 as Leibin-Ovis Chair and Interim Chief Executive Officer.
Speaker 3: 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.
Speaker 3: 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 Levenova's next leader.
Speaker 3: For the remainder of the call, I'll discuss our first quarter results and then turn to our Strategic Portfolio Initiatives.
Speaker 3: 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 cardio pulmonary and neuromodulation businesses, while advanced circulatory support remained unfavorably impacted by decline in severe COVID cases. We were particularly pleased with the way the rest of the world and Europe regions drove results.
Speaker 3: especially in emerging markets. Worth noting, these regions comprise 47% of total company revenue in the quarter.
Speaker 3: 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 and lung machine revenue increased in the low double digits, driven by new installations and replacements in the rest of the world.
Speaker 3: 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.
Speaker 3: As a reminder, our Essence Heart Lung machine received US FDA 510K clearance and march.
Speaker 3: and approvals from Health Canada and the Japanese PMDA also during that first quarter.
Speaker 3: Additionally, we initiated a broad commercial release in Europe .
Speaker 3: We now expect cardiopulmonary revenue to grow 5 to 7 percent for full year 2023.
Speaker 3: Our revised forecast includes more clarity around the rollout of essence based on recent approvals.
Speaker 3: In addition, our revision now incorporates the strong first quarter performance in oxygenators.
Speaker 3: Alex will comment on some underlying factors that impacted the first quarter result in cardiopulmonary.
Speaker 3: Epilepsy revenues increased 11% versus the first quarter of 2022.
Speaker 3: with strength across all three regions, including growth in both new and replacement implants.
Speaker 3: US epilepsy revenue increased 8% year over year driven by growth in total implants, higher realized price and product mix.
Speaker 3: In the US, 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.
Speaker 3: And our focus on engaging with KOLs at these sites remains at top priority.
Speaker 3: 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 3-5%. 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 in 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.
Speaker 3: Boss.
Speaker 3: 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.
Speaker 3: 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.
Speaker 3: For 2023, we continue to expect ACS to grow 4-6% with the majority of the growth in the back half of the year.
Speaker 3: Turning now to the Strategic Portfolio Initiative, DTD Revenue in the First Quarter was $2 million. For 2023, we now anticipate DTD Revenue of approximately $8 million, primarily from the Recovery Study. The Recovery Study continues to advance and 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.
Speaker 3: By now I'm sure you familiarize yourself with the Recovery Study. I recently met with two of the studies principal investigators, Dr. John Rush and Dr. Charles Conway.
Speaker 3: These conversations reflect the continued excitement from the KOL community.
Speaker 3: And I hope you appreciate the company's total commitment to finish this initiative.
Speaker 3: Moving now to OSA, the OSPRATE trial continues to progress with 24 study sites actively recruiting patients.
Speaker 3: Similar to my comments on DTD, myself, the board and our project team remain committed to this project as well.
Speaker 3: 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.
Speaker 3: Therefore, our expectation is that the overall R&D spend related to heart failure this year will be approximately $24 million.
Speaker 3: With that summary, I'll turn the call over to Alex. Thanks Bill.
Speaker 3: 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.
Speaker 3: In the quarter, we saw a strong oxygenator demand better than expected replacement implants.
Speaker 3: and some accelerated orders. Additionally, we were able to continue to drive strong realized price from actions taken in the second half of 2022.
Speaker 3: Far and exchange in the quarter had an unfavorable Euro-rear impact of approximately $7 million with 3% of revenue.
Speaker 3: A Joseph Gross margin as a percent of that revenue was 69 percent compared to 71 percent in the first quarter of 2022.
Speaker 3: A just-of-gross margin was unfavorably impacted by inflationary pressures.
Speaker 3: geographic and product mix partially offset by pricing improvements.
Speaker 3: Adjusted R&D expense in the first quarter was $46 million, compared to $40 million in the first quarter of 2022.
Speaker 3: R&D of the percent of that revenue was 18 percent versus 17 percent in the first quarter of 2022.
Speaker 3: The year-over-year increase was driven by continued investments in strategic portfolio initiatives and the cost associated with closing out the end-to-the-trial.
Speaker 4: A justice SGNA expense for the first quarter was $108 million, compared to $102 million in the first quarter of 2022.
Speaker 4: S-GNA as a percent of net revenue was 41% down from 43% in the first quarter of 2022.
Speaker 4: 2. In criminal investments in the OSA and DTD programs, as well as accelerated spend related to the close-out of the heart failure program. 3. Commercial investments focused on the essence launch. These key elements negatively impacted adjusted operating income margin by 300 basis points versus the prior year. 4. Adjusted effective tax rate in the quarter with 6% versus 7% in the first quarter of 2022.
Speaker 4: Adjusted diluted earnings for share was $0.43 compared to $0.48 in the first quarter of 2022. Our cash balance at March 31 was $214 million in line with $214 million at year end 2022.
Speaker 4: Total debt at March 31st was $542 million in line with $542 million at year end 2022.
Speaker 4: Next, that's including restrictive cash of March 31st with $72 million.
Speaker 4: A just a free cash flow for the quarter was $20 million, up from $17 million in the prior year.
Speaker 4: Free cash flow generation was approved by working capital management.
Speaker 4: 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 for share guidance. We now expect 2023 revenue growth on a constant currency basis between 4 and 6 percent and continue to assume approximately a 1 percent tailwind from exchange rate.
Speaker 4: We now expect adjusted diluted earnings per share in the range of $2.50 and $2.70.
Speaker 4: With adjusted diluted weighted average shares outstanding to be 54 million for the full year Adjusted free cash flow still expected to be in the range of 80 to 100 million dollars In summary, I'm encouraged by the first quarter top line performance and we remain position to drive operating leverage by urine. With that, I'll turn the call back over to Bill.
Speaker 3: Hey, thank you, Alex. Leibinova'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.
Speaker 3: We're eager to build upon the first quarter results with a firm focus on patience, performance and execution throughout the remainder of 2023.
Speaker 3: In closing, we are committed to our DTD NOSA programs.
Speaker 3: And let me be equally clear. We're also focused on accelerating new patient penetration in US 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.
Speaker 3: 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.
Speaker 1: 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 Steefle. Please go ahead. Your line is now open. Good morning, everybody. Good morning Bill. Good to hear your voice again. Good morning Rick. Thanks. It was great to hear you spot in such clarity some of your priorities.
Speaker 3: and I appreciate the summary at the end. But maybe just for those who maybe know you less well than I do, maybe talk in a little more detail about your priorities during this. And I appreciate the summary at the end.
Speaker 3: taking those, the NPI build, the focus on the rest of the world and the essence of engineering. 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 Leven Oven and the interim role 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 patience, performance, and execution. And that's from my personal perspective that's head down and all in.
Speaker 3: So I would challenge myself to operate in this interim role just the same as I was used to operating in my prior roles. The board had requested this as we made this transition.
Speaker 3: The organization has been just terrific.
Speaker 3: 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 SPI.
Speaker 3: We're really going to look closely at epilepsy and what can we further do to improve our performance in surgical penetration.
Speaker 3: really going to look closely at epilepsy and what can we further do to improve our performance in surgical penetration?
Speaker 3: We're going to look at how can we take best advantage of this already strong performance that we're seeing in the regions. My comment about 47% are revenue in those areas. It's notable. It's a really good signal about how the company is progressing when you think about the year on year success.
Speaker 3: 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.
Speaker 3: 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 later.
Speaker 3: That's a great answer Bill and thank you for that. I'm going to ask one and a half followups. One, the first is on the guide, to what extent is the 2023 guide?
Speaker 3: 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?
Speaker 3: is it inside the company outside what are your priorities, what are you looking for, what characteristics as you pursue this search? Thanks Bill.
Speaker 3: Thanks for that one and a half shirts on it like two but let me make sure that. So Alex did a nice job of sharing with you the 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 were definitely a couple. I mean even the new guy.
Speaker 3: I'll throw you an example. I said, I don't think we want to count on Russia. 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.
Speaker 3: and particularly at this stage of the year.
Speaker 3: 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.
Speaker 3: The nature of this business is that great strategic capability is meaningful. And that would certainly be at the top of the list. What I guess the real...
Speaker 3: Secondary expectation for us is to link that ability to look in a longer term.
Speaker 3: but to align that thinking with really favorable operating acumen and the ability to link those two things.
Speaker 3: to continually improving financial outcomes. That sounds 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.
Speaker 3: as trying to find that person who can really talent 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.
Speaker 3: of the company and if and when those SPIs should appear. I hope that gave you a little bit of a sense.
Speaker 3: if and when those SPIs should appear. I hope that gives you a little bit of a sense. Thanks. Appreciate it.
Speaker 4: Alex, anything to add on my prudent comments about the guy? As you said, Bill, 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're looking at the underlying market dynamics and how that really translates
Speaker 4: We saw strong oxygenator demand. We saw better than expected replacement implants in epilepsy.
Speaker 4: 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...
Speaker 4: parts are sustainable and that was the rationale for our guide.
Speaker 4: parts are sustainable and that was the rationale for our guide. Thanks again.
Speaker 1: Thank you. The next question today comes from the line of Michael Pollack from Wolf Research. Please go ahead. Your line is now open. Good morning. Thank you for taking the questions. I have two one on the leadership transition and one on depression. Bill, I'm curious for your perspective on this. You know, we get this question when.
Speaker 5: things like this happen. Why now, Damien's transition, obviously, a few weeks ago, it was kind of...
Speaker 5: a straightforward question I answer with the revenue pre-announced, it wasn't about the quarter, but how do you see this? Is there anything in here that the street needs to be concerned about or is it to your other comment? Head down and execute.
Speaker 5: And no, there's nothing else here. So any color there would be helpful.
Speaker 3: Yeah, thanks for the question. As we did try and talk about earlier, I mean, Damien resigned and we certainly appreciate his leadership and the things he did for the company.
Speaker 3: 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...
Speaker 3: That's kind of our, that's the understanding of everything that happened and it's that simple. I don't have any story to add.
Speaker 5: Understood. The under pressure, it would just like a reminder on, you know, look for the unipolar cohort.
Speaker 5: You know, the 500 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 475 patient? Yeah, give me an opportunity.
Speaker 5: interim analysis, you know, these rolling interim tested for
Speaker 5: 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.
Speaker 5: 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...
Speaker 5: follow up there is like what is required at 500 Holy 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, who really is a much better source of information.
Speaker 2: 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.
Speaker 2: 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, primary endpoint is time and response. It's somewhere in the low 60% range to hit the p-value.
Speaker 6: Hey, good morning. Thank you for taking the question. Excuse me, I was hoping that you could talk a little bit more about the epilepsy trends, both the overperformance and replacement. Where did that come from? And then the focus on new patients.
Speaker 6: And I know and speaking with Matt maybe a month ago or so he was telling me about some interesting things that 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 so Matt I'll start with EOS then I'll turn over to Bill for NPI then we can flip back on some of the things we
Speaker 2: easier confidence quarter. Now all that said, we did put some programs in place late last year to help identify patients lost to follow up. 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.
Speaker 3: comments and then PI then I'll talk a little bit about some of the things we've been we've been looking at on the sales force. Yeah, but by way of background I think some of you might recall that some of the previous calls we've referenced that the really important efforts to make sure that we've got our sales organization.
Speaker 3: appropriately targeted, resourced, and capable of really dealing with the KOOs and 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...
Speaker 3: 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.
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 US Epilepsy Salesforce late last year and then early into this year, a lot of involuntary change. In general, we had about 20
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 neuro modulation experience others in our areas like diabetes and neurosurgery so you know very encouraging and early days you know some of these new hires have made already a nice contribution to the overall performance.
Thank you. Thank you. Thank you. Thank you. Thank you.
The next question today comes from the line of Adam Meydor from Pipe Sander. Please go ahead to your line as now open.
Hi, good morning everyone. Thanks for taking the questions and congrats on the salt start to the year. I wanted to start on the CP business and you know just get a little bit more color there. It looks like the performance was really driven. Oh you asked what you asked was a little bit softer.
Are you able to just kind of flesh out those trends by region for us? It's perhaps just simply driven by essence and timing there, but any thoughts would be helpful. And then can you also just remind us how your pricing essence, I think it's being priced at a premium, but would love to get some color there as well and I had a follow up or two. Okay. Thanks.
Yeah, Alex and I've had this almost identical conversation. I'm just gonna flip it over to him because he's really got his arms around it. Hey, Adam. So, CP, we saw a really solid demand for oxygenators and the heart long machines. We met at some really big placement volumes.
OUS. We expect revenue from essence to start to contribute meaningful in the second half of the year. So that was sort of the, if you look at the regional breakdown, the U.S. was less positive in the quarter, but that's, that's because...
the consumables businesses is really, we're seeing some of our competitors experiencing supply chain challenges and frankly our supply chain is our teams 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. 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, Alex. Yeah, one of the things 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 THN3 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 OSPI relative to that that previous study. Thanks.
Sure, Adam. It's Matt. I'll go through all those. So, for OSA, we are still making progress on 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 have a strong funnel of patients, but there is some drop off. We do expect to complete enrollment.
out there felt we did on that. So I think that's, you know, the full takeaway from the GMO publication.
Sure, so no changes to Osprey, the same. In terms of the device, nothing new to report there on the current device. 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 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?
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 implanted advice and I want to make sure that
we take patients into account and patient safety into accounts. So last year we spent roughly, you know, called a $27 million. So the savings this year are minimal, but we expect to drive significant savings for $24.
Okay, perfect. Thank you. Thanks, Adam. Thank you.
The next question today comes from the line of Mike Matson from Needham Company. Please go ahead, your line is now open.
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. 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, I got it. And then as far as the just on the trial spending. So you comment on heart failure in the prior Adams questions. But I guess the just the sequencing of the 24 million in cost is here. I mean, is that kind of spread evenly throughout the four quarters?
visits and really closing out 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.
Our focus now shifts to the bipolar cohort, so recruitment of the bipolar patients, obviously continuing to monitor the unipolar patients. So our spend really does not go down at all this year.
Thanks, Mike. Thanks, Mike. Thank you. The next question today comes from the line of that next six from Barclays. Please go ahead. Your line is now open. Hi, this is Sarah on format. Thanks for taking our questions and just a quick follow up on the recovered study. At the ladies' side, you received final analysis and results by late 2024 instead of maybe earlier with mid-24. Is coverage decision by year and 24 still the right way to think about this? Yes, 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 your end of 2024. Okay, thank you for that. And then another is, you know, a thing for this quarter we've seen is there seems to be a significant ramp in utilization and volumes across many of us.
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, areas like China, where if you recall, last year, this time, higher than normal days, when was the last year when we had a lot of yesterday, we still had good weeks together and back in the fast period. So we have to keep our foremost score okay, so kind of keep a balance here, the greatestower at overall.
You know, those regions were really going through the Omacron COVID impact. And so, you know, we are absolutely seeing that recovery. And that's part of the reason we saw the substantial growth in the quarters. We said it was a...
easier comp if you will, but we feel encouraged by the, what we're seeing from a customer demand perspective. And then in epilepsy, you know, 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 their...
around 85, 86% capacity, and that covers all surgery, not just VNS, but then internationally, our business there is well above pre-COVID levels, so that is rebounded quite nicely.
Okay, thank you. Thank you, Sarah.
Thank you. There were no additional questions waiting at this time, so I'd like to turn the conference over to Bill Cosy 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 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.
Thank you, Bailey.