LivaNova PLC (LIVN) Q2 2020 Earnings Call Transcript

… and welcome to our conference call and webcast discussing LivaNova’s financial results for the second quarter of 2020. Joining me on today's call are Damien McDonald, our Chief Executive Officer; Thad Huston, our Chief Financial Officer; and Melissa Farina, our Vice President of Investor Relations. Before we begin, I want 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. Additionally, the discussions will cover certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP financial measures can be found in today's press release on our website. We have also posted a presentation summarizing the key points of today's call on our website. This presentation complements the other materials discussed in the call and serves as an enhanced communication tool. You can find the presentation and press release in the Investor Relations section of our website under News and Events, Presentations at investor.livanova.com. With that, I will now turn the call over to Damien.

Thank you, Matt. And thank you for joining us. I hope you and your families continue to remain safe and healthy during these challenging times. In the second quarter of 2020, we improved our liquidity, increased our financial flexibility, and took actions that allowed us to effectively navigate this new environment. Overall, we saw a steady improvement in procedure volumes as we moved through the quarter, with some geographies and product lines recovering faster than others. I'm going to start off by discussing some recent highlights and then results for our primary growth drivers: epilepsy and ACS. Then, I will move to our pipeline and finish with the results of our remaining businesses. After my comments, Thad will provide you with additional detail on the financials and our updated 2020 EPS guidance. And finally, I will wrap up with closing comments before moving on to Q&A. In May, the International Journal of Bipolar Disorders published data that shows combining VNS Therapy with treatment-as-usual significantly improves outcomes in patients with treatment-resistant bipolar depression. Patients treated with VNS Therapy have a higher chance of achieving a response in less time than the treatment-as-usual group. 63% of patients achieved a response compared to only 39% of the treatment-as-usual group. The study also shows that these patients treated with adjunctive VNS Therapy were less likely to be suicidal. This study was complemented with a separate publication in Contemporary Clinical Trials, detailing the design of the RECOVER clinical study. These articles further support our dedication to the patients who suffer from this debilitating disease. At the AATS meeting in May, we presented new data from our PERSIST-AVR clinical study, which is the largest clinical study for surgical aortic valve replacement. The new clinical data demonstrates consistent outcomes and lower procedure times for Perceval as compared to sutured valves. This study validates the critical benefits of Perceval, building on 13 years of clinical evidence for this technology. In the second quarter, we also announced the launch of Perceval Plus in Europe, a key innovation intended to deliver better long-term patient outcomes. Importantly, we completed a two-step financing to increase our liquidity and improve our financial flexibility. We entered into a five-year $450 million credit facility with Ares Capital and completed a $287.5 million offering of cash exchangeable notes. The combined proceeds were used in part to repay all prior debt facilities. With $233 million in cash and equivalents held at the end of the second quarter, we believe our balance sheet is strong enough to weather further COVID-19-related business disruptions. Now I'll discuss our growth drivers: epilepsy and advanced circulatory support. All net sales results will be stated on a constant currency basis. Epilepsy sales declined 45% versus the second quarter of 2019. This decrease is attributable to the impact of COVID-19 on both new patient and end-of-service implants. U.S. epilepsy sales declined 45% in the quarter. Consistent with other public commentary for non-emergent procedures, we saw our U.S. epilepsy performance bottom in April and improved sequentially in both May and June. Epilepsy sales in Europe declined approximately 50%, due primarily to the performance of regions highly impacted by COVID-19, which include the U.K., Italy, and France. The Rest of World region declined 36% relating to the suspension of non-emergent procedures in impacted areas, including Brazil and APAC. In 2020, we now expect our U.S. epilepsy business, which excludes DTD, to decline 15% to 25% due to the impact of COVID-19 on non-emergent procedures. The decline is slightly higher than we previously forecast due to the continued impact from new waves of COVID-19 cases that have been occurring in some parts of the country. We still expect sequential progress as we move through the year, and the second quarter represents the trough quarter. Advanced circulatory support sales were $6 million in the quarter, a decline of 28% from the second quarter of 2019. As customers anticipated the launch of LifeSPARC, numerous orders were deferred into the third quarter. Early this month we began the full commercial release of LifeSPARC, and customer feedback has been positive. We still expect our ACS business to grow at least 30% in 2020. Turning now to difficult-to-treat depression, sales in the quarter were $1.3 million, up 11% versus the second quarter of 2019. We still expect DTD sales of approximately $5 million to $10 million for the year. Based on what we know, we hope to transition to the registry component of the RECOVER study in late 2022, early 2023, recognizing that this is highly dependent on the continuing impact of COVID-19 on patient follow-up and scoring. In heart failure, our ANTHEM-HFrEF U.S. pivotal trial was temporarily paused in March due to COVID-19 after enrolling just over 200 patients. During the quarter, the team was able to reinitiate enrollment in more than half of the sites. We continue to focus on remote engagement to support patients, physicians, and sites. We still expect to reach the first clinical milestone of 300 patients enrolled in the second quarter of 2021. For our cardiopulmonary business, sales were $101 million in the quarter, a decline of 21% versus the second quarter of 2019. Heart-lung machine sales declined in the high teens due to COVID-19's impact on hospital budgets for capital equipment. Oxygenator sales declined roughly 25% compared to the prior year due to the decline of non-emergent cardiac procedures globally. Oxygenators experienced the smallest decline in the Rest of World region. Looking at heart valves, sales for heart valves were $18 million in the quarter, a decrease of 47% versus the second quarter of 2019. Mechanical valves performed slightly better than Perceval and other tissue valves. I'll now turn the call over to Thad for an overview of our financial results.

Thank you, Damien. I'm going to discuss the second quarter results in greater detail and then provide an update to our 2020 guidance. Sales for the second quarter were $182 million, a decline of 33% compared to the same quarter of the prior year. Cardiovascular sales were $125 million, down 26% from the second quarter of 2019. Neuromodulation sales were $57 million, which is a decline of 45% versus the second quarter of 2019. Adjusted gross margin as a percent of net sales in the quarter was 61%, down from 69% for the second quarter of 2019. The margin decline was primarily driven by mix from lower Neuromodulation sales and unfavorable manufacturing variances. Adjusted research and development (R&D) expense in the second quarter was $35 million compared to $40 million in the second quarter of 2019. R&D as a percentage of net sales was 19.3% versus 14.3% in the second quarter of 2019. The R&D spending decline is due to planned reductions in legacy products and the impact of COVID-19 on our clinical studies. Adjusted selling, general and administrative (SG&A) expense for the second quarter was $80 million compared to $108 million in the second quarter of 2019. SG&A as a percentage of net sales was 43.7%, up from 39% for the second quarter of 2019. This $28 million decline in SG&A expense is the result of planned cost containment actions. Adjusted operating loss from continuing operations was $4 million compared to adjusted operating income from continuing operations of $44 million in the second quarter of last year. Adjusted operating income margin from continuing operations was a loss of 2% compared to income of 15.9% in the second quarter of 2019. Our adjusted effective tax rate in the second quarter was 2.8%, as compared to 15.4% in the second quarter of 2019. The lower tax rate is related to changes in geographic income mix and a partial valuation allowance in the United States. Finally, adjusted diluted loss per share from continuing operations in the quarter was $0.15 compared to adjusted diluted earnings per share from continuing operations of $0.70 in the second quarter of 2019. The incremental impact of our refinancing activities in the second quarter of 2020 amounted to $0.02. Moving to cash flow, our cash balance at June 30, 2020 was $233 million, up from $61 million at December 31, 2019. Our net debt at quarter end was $517 million, up from $272 million at year-end 2019. The cash balance and net debt numbers include the impact from the recently completed financing activities. Capital spending for the first half of the year was $18 million, which is $7 million higher than the first half of 2019, related to our initiatives in digital technologies. Now turning to our updated 2020 EPS guidance. To reflect the incremental impact of our recent financing, we are updating EPS guidance for the full year. We are still forecasting 2020 sales to decline between 7% and 17% on a constant currency basis. If current exchange rates remain unchanged, the company's full-year revenue guidance will be negatively impacted by one to two percentage points. We now expect our global Neuromodulation business to decline in the range of 15% to 25% in 2020 due to the COVID-19 impact on non-emergent procedures. We believe that the largest impact is behind us, with a gradual recovery occurring in the third quarter and further sequential improvement through the fourth quarter. Sales in our Cardiovascular portfolio are estimated to decline by 0% to 15% in 2020, with strong growth from ACS largely offset by tighter capital spending budgets and the impact of lower cardiac surgery procedure volumes in both oxygenators and heart valves. Now, turning back to the rest of the P&L. Adjusted gross margin is projected to be in the range of 65% to 66%. We expect adjusted R&D to be in the range of 16% to 17% of sales and adjusted SG&A to be in the range of 38.5% to 39.5% of sales driven in large part by our decline in revenue, cost reductions, and investment in DTD. On the expense side, we have executed actions to offset some of the expected sales impact. Specifically, we instituted a hiring freeze, adjusted employee-related expenses, and continue to participate in government-sponsored support programs. We reduced spending related to travel, marketing events, and field presence, and have shifted to working with our customers and stakeholders using remote methods. The teams are focused on reallocating resources to keep expenses contained as geographies continue to open. And we continue to engage physicians in person and remotely. We reduced other discretionary spending, related to external consulting and contingency staffing. And finally, we balanced our manufacturing output to coincide with demand. We are projecting adjusted operating margin from continuing operations to be in the 9% to 11% range. Our adjusted effective tax rate is expected to be in the range of 10% to 12%. As a result of our financing, we are estimating adjusted diluted earnings per share from continuing operations in the range of $1.15 to $1.35, down from $1.40 to $1.70. It is important to note this change includes the full-year incremental impact of approximately $0.28 per share related to adjusted interest expense. With that, I'll turn the call back to Damien for some final comments.

Thanks, Thad. I'd like to finish by acknowledging the selfless dedication of healthcare professionals around the world. Their extraordinary efforts continue, and we wish health and safety for them and their families. I'd also like to extend the same wishes and my appreciation to the entire LivaNova team around the world, for how they've reacted to the last quarter and the circumstances of COVID. We look forward to updating you on our continued progress and delivering on our commitments to drive shareholder value. And with that, Catherine, we'll now throw it back to you for questions.

Good morning. Thanks for taking my questions, and Damien, good morning, thanks for taking the questions. I guess for starters, I'm sure everybody on the call wants to really understand the Neuromod commentary. Expected to be down 10% to 15%. You're saying now it's more like 15% to 25%. That's a 5% to 10% increase as far as the contraction that we should expect here. So what are you seeing in certain markets in Europe that haven't recovered? What are you seeing that's new here in the U.S. that concerns you? And then what competitively from the drug launch are you also factoring in that you may not have been factoring in before? I think you had already considered that. So just help us understand the declines there and then how to think about that business as we enter 2021?

Yes. So look a whole series of great questions there Matt. First of all, just let me talk to the whole team here that I'm just so proud of their efforts in the quarter and their extraordinary response to the circumstances we faced and how we achieved the goals we laid out in April for the quarter. And I think that's been important to how we've thought about the full year. Similar to other public commentary in Neuromod, we expect sequential improvement in the third quarter compared to the second quarter. So that I think is important. We don't expect the performance to be linear. COVID flare-ups will cause ebbs and flows. But the early signs for the quarter have been encouraging. Nevertheless, we just don't see a linear change here. So what we're seeing is that the impact from drugs, particularly Epidiolex, were the same in Q2 over Q1. So we don't see any particular change there. We already took into account the other drug launches in our earlier guidance and that's included in this. Again, we haven't seen a particular response to those new drugs. Our efforts here really are focused on how we change our business model to partner with these comprehensive epilepsy centers and focusing more on where DRE patients are. So over the previous couple of quarters, we've changed our story to much more focus on how VNS is accretive to any drug cocktail. We've improved our key account management focus. We've added medical science liaisons. We've added nurse educators, so that the conversations are different with patients. We've worked on a lot of remote processes to continue our support there. And so, we're really taking a look at the whole system in the U.S., but importantly also making sure we drive non-U.S. business as well.

Okay. But just to maybe put a little bit finer point on that Damien. I appreciate the feedback. My math is you're down about $30 million maybe $40 million versus what we kind of had been expecting. That's primarily U.S.-based. Are you saying that 10%-ish of your U.S. business is potentially at risk here with more COVID flare-ups in the back half of the year? Is that how we should frame it up?

Hey, Matt, it's Matt. A couple of things on this. So when you ask about the regions, I would say in our international business, some of the countries that are stronger for us, if you look at Brazil, China, Japan, and the Middle East, they haven't come back as quickly in Neuromod as maybe some other markets. And then also in the U.S., as you're seeing from third-party reporting, some of our other competitors reporting, Neuromod just had a little tougher go in the second quarter than some other procedures. So part of that was factored into our estimate as well.

Got it. Can you provide any insights on LifeSPARC? You mentioned a full year growth of 30%, which is excellent. Could you quantify the level of delayed purchases in Q2 and share what you're observing early in July as you begin to roll that out? Thanks.

Yes. I would say the early stages have been very encouraging. As I said, we saw delayed orders into the Q3 because of the anticipation of LifeSPARC. The LifeSPARC limited commercial release was very successful. We had over 4,000 hours of utilization, as we revved into the launch. And I'm really pleased with the information we got back from that and how it informed what we do in this quarter. So as I said in the commentary, that's why we're saying we're still committing to at least 30% in the full year.

Got it. Thank you.

Thank you. Our next question comes from Rick Wise with Stifel. Your line is open.

Good morning, Damien. Could you provide an update on the TRD trial? I might have missed it if you already discussed it, but can you share where we stand with enrollment and whether everything is progressing smoothly? How should we view the upcoming six to twelve months as clinical operations normalize? Any insights would be appreciated. Thank you.

Sure. Look I think the team here has focused all their efforts on what they can do in the absence of being able to implant patients. So what are those things? One is site activation, which we've managed to continue even with remote behaviors. So I think that's an important step for us as well as being very focused on how we stack the funnel of patients at the start of the whole inclusion/exclusion criteria. What we want to make sure we do is when procedures do start opening up again that we can start putting patients through that screening process quickly. So the two things were about site activation and patient stacking. Very importantly, we're continuing to focus on what we have to do to get to the transition to registry, which as I said in the commentary is late 2022 early 2023, and that will be dependent on CMS' review timing and the continued impact of COVID. But again, I remain very encouraged by the way this team has continued to focus their efforts and engage with the key opinion leaders, right through this whole last quarter.

Great. And maybe turning to heart valves, which were down so sharply. Can you give us a little more color on what's happening there both as a whole and geographically? And what impact are you expecting, or what should we dial into our thinking about the Perceval Plus launch's impact on the second half?

Yes. Again, we anticipated that Q2 would be the lowest point, with improvements expected in Q3 and Q4. Our heart valve business is more concentrated in countries that experienced a greater impact from COVID than the overall SAVR market. Regions such as Italy, which was among the first to face the COVID crisis in Europe, along with Brazil, the Middle East, and Eastern Europe, have been more significantly affected than others. This situation explains the heart valve performance we observed. We believe that as patients and clinics begin to reopen, we will see a rebound. The Perceval Plus, especially in Europe, plays a crucial role in this recovery. The technology's advancements indicate potential for better patient outcomes, and early feedback from the limited commercial release we conducted last year supports this optimism. We are hopeful about its impact, particularly in Europe.

Yes. As we consider your current capital position, you've clearly stabilized the balance sheet and have ample cash. Could you elaborate on your focus on profitability in light of the additional debt and new cost reduction initiatives? Also, how long do you anticipate your cash will sustain you, especially with significant spending expected in your clinical programs? Thank you.

Yes. That's a great question. Look, I think just in terms of capital overall, our focus is on capital preservation. And until we get more clarity on the timing and impact of COVID-19, preserving cash and retaining a strong balance sheet is really key to us. COVID has caused everyone, I think, to rethink their business model and we're no different. So our intention is to make sure we focus on the fundamentals, which are about epilepsy and ACS, right? We've ring-fenced that and what we have to do to get those growing. We've ring-fenced the strategic portfolio initiatives, particularly DTD and heart failure. That's got all sorts of effort that we need to continue. And then, we're working hard to improve our cash flow generation, and you'll see that some of those results read through in this quarter. So we haven't changed those focus areas. What we have thought more aggressively about is the model, including how to manage costs tightly. There are going to be disruptions to demand, but being very aggressive about positioning the company for long-term growth is key to us. Looking at the end-to-end of our business model is how we've approached that.

Thank you.

Thank you. Our next question comes from Scott Bardo with Berenberg. Your line is open.

Yes. Thanks so much for taking my questions. Great. Three questions, please. So, yes, just first of all, I wonder if you could explain why you see gross margins a little bit softer than your initial expectation. Is that aligned with your comments of weaker-than-expected Neuromod than you saw in April 29? I think on SG&A, it's pleasing to see that you've exerted some more cost controls, but that seems to have been entirely pumped back into R&D, with more spending in R&D than you initially outlined. So I haven't seen any new projects announced today and your revenue guidance is the same. So why is there not the same discipline on the R&D line this year? Why is that stepping up? So that's the first question set please. The second question, just really wonder if you could give us a bit more clarity as to the rationale for your refinancing, particularly with respect to your senior credit facility, which appears to be a quite expensive financing cost. Can you spell out to us, please, what will be your net finance expense and cash costs this year for the company? And do you have the ability to work that down next year by absolute reductions of debt? And last question, please. Obviously, this experience with COVID has been a shock to everyone in the med-tech industry. And I'm pleased to see LivaNova keeping its focus and delivering improvements and progressing its pipeline. But, obviously, this situation has created quite some pressures for the group, also from a balance sheet and liquidity perspective. The nature of the question is, is there increased drive for the executive management team and the supervisory Board to start exerting the sort of cost discipline that can get you back to a reasonable margin as a company, or are you happy to just continue high investment levels and have a more gradual improvement? So I just want to understand whether this experience and pressures that you've seen has changed your appetite to improve profitability?

Let me start with the last point, Scott, and then we'll return to the previous topics because it ties into other comments. First, as I mentioned earlier, COVID has prompted everyone to reevaluate their business models, including us. We saw a 25% sequential decrease in SG&A for the quarter, which reflects significant effort to make that happen within such a short timeframe. These changes are crucial for us as we reset our approach to the company. We have made important decisions regarding not only SG&A but also R&D, which also showed a sequential decline in percentage terms. There may be some fluctuations overall in the P&L, but the adjustments we're implementing primarily affect EPS related to refinancing. During the quarter, we've taken decisive actions. We're focusing on key areas like epilepsy, ACS, depression, and ANTHEM. We're actively assessing how other parts of our business model need to be restructured to enhance cash flow and margins. This is a vital aspect of how we've been rethinking our strategy in light of COVID. Regarding debt, Thad, I'll continue on that and you can add your input. We had plans in place before COVID that needed significant revisions as the pandemic unfolded. Our analysis wasn't limited to just debt restructuring; we took a comprehensive look at enhancing our financial flexibility and stability. We considered various options, balancing coupon rates, term lengths, shareholder dilution, covenant structures, and simplifying our strategic relationships. We're confident that our combination of private debt and exchangeable securities represents the best choice for LivaNova and our shareholders. Thus, we've made deliberate decisions aimed at strengthening our financial standing.

Yes. I would just add a couple of comments, Scott. Obviously, having the biggest impact in Q2, due to COVID, had a fairly material impact on our gross margin and the financial profile of the company. And so if you look at our gross margin, it was significantly impacted because of the mix effect of Neuromodulation. But we also had unfavorable impact of fixed manufacturing overhead that occurred in the quarter, which we don't anticipate to occur in the future. As the sales mix improves in Neuromod, ultimately the gross margin improves, and profitability and cash generation will improve in Q3 and then sequentially in Q4. As Damien said, we took this as an opportunity to really focus on the fundamentals and obviously improving both our expense base. We took a lot of actions around managing labor costs, implementing headcount freezes, bringing down expenses, and all discretionary spending, and ultimately looking at any and all opportunities to reset the cost base. The R&D did come down sequentially. We're still trying to continue the investments in the critical programs. We're not adding new programs, but just delivering on the milestones that we have in front of us. And then again, I think that the financing that Damien mentioned was something that we were planning to do and address, but ultimately positions us well, provides improved liquidity, financial flexibility, and allows us to navigate this new situation.

Yeah. Thanks for guidelines. Sorry, I did ask quite a lot of questions at once. But can you be a bit more specific please? What is your net financial expense going to be this year? And is there an ability to lower that next year, if you improve margins, recover earnings, and pay down absolute debt? I'm wondering, are we at a maximum point of dilution? If you could just comment there that would be helpful.

Yeah. So this year, I mentioned in my commentary the incremental impact from financing was $0.28 of EPS, due to the financing. That is really the only adjustment we’re making to our EPS guidance. We’ve changed some things in the middle, but ultimately that's the only reason that we're re-guiding EPS. And so that’s the impact. We are able to repay after two years the debt facility with Ares Cap.

Understood, sorry to come back to this. So basically, your incremental net income, with net interest expense going up by about $15 million, can you provide those numbers?

We could follow-up exactly the number, but it's equivalent to $0.28 of EPS.

Okay. And last question please. And just following on from your first comment Damien, is it fair to say now, given these circumstances that LivaNova's previous expectation to be a 20%-plus margin business in 2022 is no longer attainable, or is that something you think that you can still shoot for?

I think what we're going to do is work really hard to achieve the targets we laid out. All sorts of things that are different than we laid out in 2017, notwithstanding, the biggest one of that being COVID. Our mission is to, as I said, drive growth, improve cash flow, and cash conversion, and better cash generation. So we've got to make sure we're making the best decisions around the whole portfolio to do that. Again, all sorts of things have changed, but our goal is to keep moving towards what we laid out in 2017.

And the expense actions that we demonstrated in Q2 really show that we can manage in a different kind of cost structure going forward. I think, that will help us improve margin over time.

Thanks, guys.

Thank you, Scott.

Thank you. Our next question comes from Raj Denhoy with Jefferies. Your line is open.

Hi thanks. Good morning. Maybe just a couple of follow-up on some …

Hi Raj, how are you?

…Pretty good thanks. Just a couple of follow-up on some earlier questions, so on the last one. So the $0.28 dilution this year from the financing that's for the half year. So next year we should assume closer to $0.56 or so for dilution, on the new financing?

Yeah, about $0.55.

Okay. And I guess the earlier question on VNS, the epilepsy business. I guess what's perhaps a bit surprising is we had thought that, given that replacements are such a large percentage of that business, it might prove a bit more resilient. So have you seen softness on the replacement side as well as de novo? Maybe you can give us a little bit more detail around that?

Yeah. I think NPI is an end of service performed about the same in the second quarter. And it's roughly 60% end of service and 40% NPI. I think for us, end of service is much less elective than a new implant. That’s probably why you expect a bounce there. The countervailing factor is that before you get that implant for the replacement, you need one more final device interrogation to be scheduled before the surgery. Patients and caregivers need to be available to go into a physician's office to do that. So that's probably the counter to the need for an end of service. And we're working on ways and have seen ways to continue that. As I said, end of service still performed in the quarter. But what we need to do is make sure we figure out how to ensure patients and caregivers can return to physicians' office for that one last screen.

Okay, that's helpful. Regarding the pipeline, for ANTHEM, you mentioned that by the second quarter of next year, you expect to reach 300 patients. Could you clarify what the next steps are once you reach that milestone? There are several options available, so what are your thoughts on the timing after hitting the 300 patient mark next year?

Sure Raj. It's Matt. To assess the functional endpoints, we begin with a two-step process that requires nine months of follow-ups. By midyear enrollment, we will have completed the full follow-up of all patients, allowing us to review the data. We are considering how long it might take to gain FDA approval and whether a panel will be necessary; one competitor recently went through the process without a panel, which suggests there may be some flexibility. If you factor all this in, you can estimate when we might seek FDA approval for those functional endpoints before completing the entire study.

And I guess will it take you seeing the data to decide which path you will go down, whether you'll try to get approval on the …

Yeah.

… the smaller subset with the functional endpoints?

Exactly, looking at that data will be important, not just for the U.S., but also in the CE marked countries. We have CE Mark for this product already. And that data will be an important decision point for what we do internationally as well. Again, there's a potential to commercially release VITARIA into those CE Mark countries at that point as well.

Great. And sorry just one very last one, I might have missed this, but did you give an update on the number of implants for depression at this point?

No, we didn't. And we said we weren't going to update quarterly on that until we get to milestones like the outline that we gave I think back in the Q4 results. So for us we're not going to update quarterly. So we're just going to work towards these milestones of when we shift the registry.

Understood. Thank you.

Great. Thanks, Raj.

Thank you. Our next question comes from Matt Taylor with UBS. Your line is open.

Hi, good morning. Thank you for taking the question.

Hi, Matt.

First question I want to ask is a follow-up on the Neuromodulation business. So you see a little bit more deferment here I guess than you might have expected. And I just wanted to understand, do you think that's temporary? And do you see a lot of these procedures getting done in 2021? Could you have a bolus then, or do you think that you're losing patients through the funnel? Maybe you could characterize that a little bit.

Sorry, you're in epilepsy, Matt?

Yes.

Yeah. No, I think again what we're working here is on both NPIs and end-of-service as best we can to continue the funnel. As we said, this is a highly fluid environment. The ebbs and flows of COVID are really important here to track. We're doing that at the account level. That's why; we didn't change the range of the overall sales guidance for the company globally. But what we're committing to do there, as we said in the previous guidance, minus 7% to minus 17% globally. The puts and takes are very much based on how markets respond to various opportunities to open up and how patients come back to clinics, how surgeries begin to open up. So that's the way we're viewing it. That's account-by-account, geography-by-geography.

Okay. Well, I guess I'm just trying to understand the Neuromod results, the epilepsy results this quarter were down more than we would have expected. And I was trying to get behind the patient factors or the facility factors that you think are impacting that the most. Is it because those patients are afraid to go in, or they're losing coverage, or facilities are not open? Why is it more impacted than some other areas that we've seen?

Hi, Matt. It's Matt Dodds. So you're right. I mean, my take is that Neuromodulation as an industry, not just epilepsy, it saw a much bigger hit in the second quarter than a lot of other areas, especially in April. I would say we tracked very consistently with the market overall where tough April got better in May, got better in June. Some of it you're correct. Some of it was the physicians just weren't available for the actual follow-up. And then in a lot of cases whether it was the patient or for epilepsy, I think a lot of times it's the caregiver they just weren't ready to go back to the hospital. We definitely had some dislocation on that front. And then, I guess to your point, we do assume, as we said earlier, that sequentially we'll see more in the third quarter than the fourth quarter. We're just not ready yet to say there's going to be any pent-up demand or a recapture rate in the fourth quarter or even early next year yet. We just want to see how this really moves as we get through the third quarter.

Okay, okay. Thanks for that. And then just one follow-up on that point. So when you're looking at the sequential improvement that you're talking about, I'm assuming that that comment applies to all your businesses that have been down basically. Can you just comment on them differentially? Do you think one is going to come back more or less than the other? And what are the main factors to consider there?

Well, I think that the first factor is really epilepsy, right? I think that's the big driver timing of patients returning to their physicians. I think the other procedures are going to really heavily depend on how they bounce in terms of procedure cancellations versus procedures opening. The timing and regional impact of elective surgeries, I think, is important. I think we expect ACS to be up sequentially faster than the other groups. Again, the focus there on ECMO is, I think, a big tailwind for us. And in terms of heart-lung machines, I think clearing up this capital budget uncertainty is probably going to be the driver on that. So first group, epilepsy; second, the other procedures heavily dependent on clinics opening; third, ACS and the tailwinds for ECMO, and of course very heavily linked to the LifeSPARC launch. And then fourth, HLMs around capital budgets. That's how I categorize the buckets.

Great. Thanks, Matt. Thanks, Damien.

Sure, Matt.

Thank you. Our next question comes from Mike Matson with Needham & Company. Your line is open.

Yeah. Thanks. So I just wanted to follow up on Matt's questions about Neuromodulation and the slower growth outlook there. Just curious about the impact of the economy. So COVID is one thing but it seems like even once we get a vaccine and hopefully get past the pandemic, the economy could continue to be weak. So I was just curious if you had any sense for what you've seen in the past with recessions and the impact on Neuromodulation either people using insurance or just not as willing to maybe pay the out-of-pocket copay deductible whatever to get the procedures?

Yeah. We don't see that as being a big impact. I think our macro impact here is COVID. Bouncing out of COVID is going to be key. But as I said about patients also helping patients, being able to get reads, being able to do things remotely, I think is going to be important. Even within the COVID framework, are there things we can do differently? We're definitely exploring those, and we've been working on that for the last quarter. But in terms of other macro things like recession, we don't believe that's an impact for us.

And then also Mike, I would tell you within Neuromodulation and epilepsy of the three major buckets; Medicare, Medicaid, and Commercial, Commercial is the smallest.

Yeah. Probably the only area that we would anticipate or even forecast some impact on the economy having an impact on our business is really related to capital purchases. We've tempered a bit of our forecast on HLM.

Okay. Thanks. And then good to see that the cash balance is up significantly given the refinancing. Can you just remind us on the heater-cooler issue? Have you paid everything out now, or are there any additional payments you have to make there?

Yeah. We paid the majority out already both last year and Q1. There's a remaining reserve of $49 million, and roughly that's what the payments that are expected to go out. We're trying to obviously resolve as many of those this year. But again, the court dates tend to move during the situation.

We've continued to make good progress there though. I'm really pleased with how the team is dealing with that. And there are no trials scheduled until September. And again as Thad said they could move.

Okay, got it. Thank you.

Thank you. And there are no other questions in the queue. I'd like to turn the call over to Damien McDonald for any closing remarks.

Thank you, Catherine. Again thank you to everyone. Thank you to the team and thank you for your continued engagement on LivaNova's progress and our transformation and we look forward to updating you next time. Cheers.