Good day, ladies and gentlemen, and welcome to the LivaNova PLC First Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce the host for today's conference, Mr. Matthew Dodds, LivaNova's Senior Vice President of Corporate Development. You may begin, sir.

Thank you, Demetrius, and welcome to our conference call and webcast discussing LivaNova's financial results for the first 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 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. Reconciliations to the most directly comparable GAAP financial measures can be found in today's press release that is available on our website. We have also posted a presentation to our website that summarizes the points of today's call. This presentation is complementary to the other call materials and should be used 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, and I hope you and your families are all safe and well. Before we discuss our first quarter results and updated guidance, I'd like to make a few comments in light of the pandemic. Since the outbreak of COVID-19, our priority has been to continue to support patients' health care professionals and our employees. We remain focused on providing life-saving technologies and supporting our customers. We are still in the early days of assessing the impact of COVID-19 and the impact that it's had and it is expected to have on our business. I would like to take this moment to thank all our associates worldwide who have shown remarkable resilience through this crisis, particularly those on the front line and in our manufacturing facilities who have maintained our supply chain. As Thad and I will outline during the call, in the first quarter of 2020, COVID-19 started to impact the Rest of World region in mid-February, followed by Europe in early March, and the U.S. in mid-March. I'm going to start off by discussing some recent highlights, and our sales results by business. After my comments, Thad will provide you with additional detail on the financials and our revised 2020 guidance. Then I will wrap up with closing comments before moving on to Q&A. In late February, we entered into a research collaboration with Verily as part of our RECOVER depression study. This will allow us to capture biomarkers of depression and data on patient behavior using technology and analytics provided by Verily. These data will provide further insights into depressive episodes and a patient's response to VNS Therapy and its impact on DTD. At the ACC and World Congress of Cardiology meeting in March, we presented 2 posters. The…

Thank you, Damien. I'm going to discuss the first quarter results in greater detail and then provide an update on our 2020 guidance. Sales for the first quarter were $242 million, a decline of 1.8% compared to the same quarter of prior year. Cardiovascular sales were $152 million, down 0.2% from the first quarter of 2019. Cardiopulmonary sales were $116 million in the quarter, a decline of 2.2% versus the first quarter of 2019. Heart-lung machines sales declined in the mid-single digits, primarily due to difficult year-over-year comparisons globally. Oxygenators sales grew in the low single digits related to strong performance in the Rest of World region including Southeast Asia, Eastern Europe and Brazil. Turning to heart valves. Sales for Heart Valves were $25 million in the quarter, an increase of [0.6%] versus the first quarter of 2019. Heart Valves benefited from an easier comparison related to our transition to direct sales that occurred in certain markets in the Rest of World region in the second half of 2019. Now let's turn to Neuromodulation. Sales were $90 million, which is a decline of 4.6%, versus the first quarter of 2019. Until mid-March, U.S. Neuromodulation have been tracking to a mid- to high single-digit growth rate for the quarter. Neuromodulation sales in Europe grew in the mid-single digits, led by the U.K. and Germany. The Rest of World region declined in the mid-teens, in part due to softness in the Middle East. Adjusted gross margin as a percent of net sales in the quarter was 68.3%, down 100 basis points from the first quarter of 2019. The margin decline was primarily driven by mix from lower Neuromodulation sales. Adjusted R&D expense in the first quarter is $41 million compared to $37 million in the first quarter of 2019. R&D as a…

Thanks, Thad. I'd like to finish by acknowledging the selfless dedication of health care professionals around the world. Their extraordinary efforts continue, and we wish health and safety for them and their families. We look forward to updating you on our continued progress and delivering on our commitments to drive shareholder value. And with that Demetrius, we're open for questions.

[Operator Instructions] And our first question comes from Raj Denhoy with with Jefferies.

I wonder if maybe we could start with the trajectory of the business here as you move through April. I appreciate it's been tough for most companies. Is there anything you can offer in terms of how things have trended here just in the first month of the second quarter?

Yes, Raj it's a good question. I would say that I characterize this as modest signs of light. We've seen our monitoring of hospital by hospital, state-by-state in our weekly calls internally. We've seen modest improvements in some hospitals, some areas, some states, little green shoots in a few countries in Europe as they've changed their regulations around what they consider essential and elective. And similarly, some smart signs of growth in China. So again, early days, but we are seeing small, modest signs of light.

Understood. I guess, I'm just trying to reconcile that with the guidance cut rate, which is pretty substantial on the top line. And also, I guess, the commentary in terms of resumption, particularly in VNS, by the fourth quarter back to kind of pre COVID levels. And so I guess the question is really around your confidence in the current outlook, right? Because things aren't very fluid at this point. So just trying to the gauge kind of the airbands around what you offered in terms of guidance at this point?

Yes, I would just add. I mean, I think to me, the way we think about the guidance and the range is -- it's highly fluid and there's a level of uncertainty. And so we purposely put some fairly broad ranges for the quarter and also for the full year. But again, we're monitoring it weekly. We're studying the market. We're even looking at kind of a state by state, country-by-country view. And again, we're going to continue to monitor, but we're increasing in terms of some of the confidence, again, around just seeing some modest progress, as Damien described.

Okay. Maybe just one last one on kind of the operating expenses, right? So again, everybody's models are slightly different. But in ours, it looks like the combination of R&D and SG&A is coming down by about $100 million from where we were previously. And so I'm trying to get at where that is coming from, and if those cuts are sort of -- how deep that is in a sense. And so when things do come back, how much of this cost reduction you've embarked on is going to be sort of difficult to recover from or how quickly can it kind of snap back?

No. I think to me, I described the number of things that we are doing to protect the income. But at the same time, it's really important that we continue to invest in the long term. And so we are continuing to support our trials. Of course, enrollment is obviously going to be affected because of just delays in the challenges of just getting clinical trials up and running. We are working and taking advantage of headcount freezes, travel restrictions and obviously, any government support to help us protect, again, some of the expense cuts. But we are trying to balance short and long term, of course.

So to that end, Raj, we've ring-fenced studies that are critical to our long-term value creation, like RECOVER and ANTHEM trials. We've ring-fenced new product development around key things like LifeSPARC and Polaris, and Iris, and other things that are less critical, less urgent, we've put those on hold.

And our next question comes from Rick Wise with Stifel.

Okay. Sorry about that. Maybe start off with LifeSPARC. Clearly, you have some optimistic thoughts about recovery there, expected to deliver at least 30% ACS growth for 2020. Maybe just update us on where you are with your ability to supply the product on the manufacturing side? And does COVID accelerate LifeSPARC demand? Pull forward demand? Just some more color and support of that particular positive piece of your outlook?

Yes. So 2 things there. First, on the supply and manufacturing. I will tell you, I think the team made great progress there in our weekly Friday call with that team. I continue to be impressed with how they run the project management of that and our component supply that we talked about at the end of last quarter is moving well. And so we still expect to be able to execute the commercial release in the second half, as we announced earlier. So I'm really pleased with that progress. On the demand overall, I think we've seen great demand from our existing accounts. So we are in an account penetration play here. So it's existing accounts that are using more protect to, more TandemLung, that's the respiratory support product. But interestingly, the right ventricle also needs to be supported when you have these events in this respiratory distress. So that's why I think we're seeing this uptick in ProtekDuo. So I think the teams continued to execute well there, and we see strong performance from that group in the U.S. and in a few countries internationally. So I think that's why we're a bit more bullish on the full year results.

So Rick, it's Matt, also. We talked about before, one of the keys of LifeSPARC is getting more controllers, also the ease of use of this controller. We can expand the footprint. Today, we're in less than 200 centers in the U.S. There's room to go to 500 or more. ECMO is a very valuable device for respiratory distress, as you've heard. So that's a key component. The back half of the year is expanding, not just going deeper into accounts, as Damien said. But this will give us the ability to expand into a lot of new accounts who will find this product very easy to use and will then embrace an ECMO practice.

Okay. Turning to -- thank you, Matt. Turning to the DTD trial. If I heard you correctly, correct me if I'm wrong, you had 250 patients enrolled by the end of the second quarter. I think you talked about the $5 million to $10 million contribution impact as well. But maybe if you could expand on your comments there, how does -- talk about restarting the trial as things recover. What should we expect? What are you expecting? And Damien, how does the time line shift -- the time line -- how do the time lines that you've articulated in the recent past shift now in light of this pause in enrollment?

Yes. So to get to that last part of that question, we think a shift of about 6 months is what we're forecasting. What happens? It's really about patient enrollment and the implant sequence. That's what's slowing down. What's not slowing down is this team's work on the infrastructure of setting up the trial. So they've continued to work diligently on-site activation, and we've been doing a number of remote site activations, I think, which is fairly novel process. We've also continued to work on patient identification and patient awareness of the study and done a number of digital activities to engage with people in that DTD community to push them to be aware of the trial. So related to that, we're also continuing our work on how to engage with the private payers. And a recent hire of a specialist for health economics and reimbursement in that area is a really important key step that this guy has experience in this space and patient advocacy from pharma. And I'm expecting a lot of engagement there as we continue that process. So infrastructure is still progressing. It's really about patient enrollment and implant that's the slowing step here, and that's why we're saying plus 6 months for the target that we previously talked about.

Great. And just last for me. Obviously, on the debt and financing side, you've made some important and critical progress with your covenants and some of the details you've announced. I mean, can you expand on your comments what kind of funding do you feel like you need? When is it needed? And how -- maybe you can give us more concrete input about what to expect, how you're approaching this? And just how you're thinking about -- does the lower end of the guidance, maybe another way to say it, drive the need for financing? Or if you hit the upper end, you need less? I'm not sure how to put it all in context.

Sure. Yes. I think as we stated, we've amended the covenants of all of our facilities to give us enough room for, let's call it, the next 15 months, which is usually the period that you want to test from an audit perspective that, of course, going beyond that is ultimately what we're looking at. So I think that gives us a lot of flexibility, and we continue to look at other facilities. So for example, we had ended the quarter with $126 million in cash, and we added recently another facility from Barclays last week. And we're just going to continue to look at what else could we do. We feel that even with the downsides that we have a number of different levers that we could pull on the expense side to protect income and cash flow. And with the facilities we have, is sufficient to meet our liquidity and our debt obligations. But I think this has taught us all lessons is to just evaluate different strategic financing alternatives and to have additional capacity. And so we are looking at the offerings of potentially equity debt just looking at what else could we do just to firm up and have more additional headroom. But I don't have major concerns. It's just been, obviously, we've had to address what was a really strong balance sheet 2 years ago. We were -- our leverage was well below 1x net debt to EBITDA. But given the 3T liability and the payments that we've made, our debt levels went a bit higher. So of course, we needed some additional headroom with covenants, but we're looking at just additional instruments.

So just to follow-up quickly on that. So you're saying this is more thinking long term, and this is something that -- when you talk about the additional financing that you very much want to have nice to have, important to have, but not so critical, not necessarily anxiety proposing for the next 6, 12 months. I'm not sure exactly what you're saying, Thad?

Yes. No, no. I think it's both, right? So to me, there's a level of uncertainty, Rick, in this environment. So we want to cover short term, right? And at the same time, we've been in the process of looking at restructuring our current facilities. And so if you look at the details of what we have, we a repayment schedule of our $350 million facility in Q3 and Q1 next year of $70 million in those 2 time periods. We also look at other instruments to try to balance debt and equity depending on the scenario. So it's kind of a short-term creating more headroom, but then also taking longer-term steps, just to recapitalize the company structure. Is that clear?

Yes. Thank you for the thorough detail.

And our next question comes from Scott Bardo with Berenberg.

Damien, yes, so just a little bit more understanding, please, of the guidance framework. And obviously, I appreciate you've taken a stab at this guidance framework. Just to understand it fully, I think you said that you would anticipate cardiovascular to be down about mid-single digit for the full year, was that right? That's your base case assumption?

Yes, mid- to high single-digit for the full year. Yes.

And just to understand that a bit further with respect to the cardiopulmonary business, which has been largely for CABG procedures and so forth, normalized world, not considered deferrable or less likelihood to defer, have you seen or are you seeing signals that, that should decline? And what is the compensatory effect, you think, from the additional ECMO provision that you now have? Does that confer a degree of stability to that business that wasn't there before? Just really want to understand those moving parts a bit more, please.

Yes. I think, obviously, what we've talked about here is we expect the biggest decline in Q2 with elective procedures being down, and that's going to impact oxygenators largely. And now our ECMO business unit. So the TandemLife business plus the small ECMO business we had in our cardiopulmonary portfolio is up, and we've seen a small increase there. But not to offset the Oxy and HLM business. So the business is growing. It's an important part of this, but it's also a very complex part of the procedures. And you don't always goes back from ventilator to ECMO. And so we're pleased to see the uptick, but we're not banking on that being a full compensatory effect for all the cardiopulmonary portfolio.

And Scott, it's Matt. I would say -- I know you like to go into detail on this. Probably if there's one area to think about it being under pressure in cardiovascular, it's going to be capital equipment in the U.S. and Europe, right? So HLMs, ATS, that's where we're forecasting to see a big hit on that business. So that's not truly procedures. That's more of a capital component.

Okay. That's helpful. And again, the walk-through is a significant impact in Q2, still declines in Q3, more normalization in the fourth quarter. Is that how you think about it? And any recent noises from hospitals about reactivating elected procedures or at least starting as early as now soon? Have you baked in a relatively conservative negative assumption here? That's what I'm trying to understand.

Your opening statements is how we've modeled it. And again, what we try to explain is that we are looking at this weekly with our commercial teams in Europe and international country-by-country in the U.S., hospital by hospital, state by state. Again, I think everyone is aware that the state differences in the U.S. are very, very compelling. So that's where we've tried to be a bit more granular on the state level differences. But that's -- our model broadly is how you summarized it.

Okay. And so in nature of the question for Neuromodulation, please. So clearly understand you're expecting some sharp decline. So just to understand this further, is it your expectation that you see a relatively stable replacement business, which is 50% of -- or so of these U.S. sales, is my understanding? And so that new patients are significantly down for the next few quarters. Is that basically the flow?

Back to the same idea about the model. Biggest impact in Q2, a small recovery in Q3, getting back to sort of normal sales in Q4. And I would say on NPI versus the OS, we've seen a more dramatic impact on the new NPIs, the new patient implants, and a slight decrease in the end of service. And again, very much impacted by differences in what people consider are elective. The U.K. and Germany, for example, just this last week that battery replacements are an essential surgery. So we're monitoring this country by country, state by state.

Okay. Understood. And sorry, just a last clarification. Your revenue framework is outlining potential for down 17% sales. I'm not sure I understand that in the context of your biggest business, cardiovascular, being, let's say, mid-single digit. It seems to me that or even mid- to high single digit, that wouldn't make sense given the commentary of 10%, 15% Neuromodulation decline. So are you essentially saying that the most likely scenario is the low end of the range? I just want to understand that.

Scott, it's Matt. So no, what we did, if you look at the growth rates we gave by the major businesses, you're going to fall in the middle of that minus 7% to 17%. We just want to have a slightly wider range, given all the uncertainty right now. So we're not encouraging you to go to the right to the worst part of the range.

Okay. Understood. And encouraging that you see things returning to more normalized volume in Q4. Of course, with no crystal ball, but that seems a sensible assumption to me. Now as we think about 2021, and I think this is more of a relevant number to look at, can you at least give us some sense of where you think you can recover the business to, according to your sort of midterm plan? Should we expect an earnings number that's at or above 2019? Is that a good sense actually as to how this business trajectory recovers over the next 12, 24 months?

Yes. I would say it's a bit premature to predict 2021 at this point. I do think that, again, depending on kind of how -- whether it's a V-shape recovery or U Shape or W. We just don't know at this point, Scott. But again, we are going to take every action that we can to firm up the business to ensure that we're making both short and long-term decisions to get this thing back to where it should be, whether it's the previous 2019 results or the previous guidance on 2020, we just don't know at this point.

Okay. And last question then, please, for me. And again, I congratulate you for extending the terms of your covenants. But I wanted to understand a little bit better the concept of equity or equity-linked debt. Obviously, leaving over shares are broadly trading where they were when you merged in 2015. So I would argue your shares are not really in a position of strength. Why would it make sense to consider equity when debt is cheap and you have headroom in your covenants, and more importantly, has this experience where debt has got a little bit ahead of where you would like it changed your thoughts on acquiring loss-making developmental assets? Or the very high levels of internal investment you make, which are artificially compressing your margins?

Great question, and you're absolutely right. It's how we see it as well with this balance of what is kind of the right kind of facilities that could help us as LivaNova, where we're trading today, looking at our relative valuation, looking at the various tools in the market, and how is the market developing for these tools as well? And we're trying to balance a little bit of equity, a little bit of debt. But try to find the right kind of thing to address kind of short and long-term capital needs. We haven't decided. And again, we're exploring options. And we just wanted to highlight that today. But you're absolutely right. I think we would also think about very carefully about doing future M&A, especially dilutive deals. The TandemLife deals are accretive, immediately accelerate growth. Those are the types of acquisitions that we had obviously be keen on continuing to do.

Ladies and gentlemen, this concludes our Q&A portion of today's conference. I would like to turn the call back over to Matt Dodds for any further closing remarks.

Okay. Well, Demetrius, thanks very much. Thank you for everyone for joining us, and we look forward to continued conversation and reporting on our shareholder value creation as we move forward. Be safe, everyone.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect. Everyone have a great day.