Good day, ladies and gentlemen, and welcome to the LivaNova PLC Fourth Quarter and Full Year 2017 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Ms. Karen King, LivaNova's Vice President of Investor Relations and Corporate Communications. Please go ahead.

Thank you, and welcome to our conference call and webcast discussing LivaNova's financial results for the fourth quarter and full year 2017. Joining me on today's call are Damien McDonald, our Chief Executive Officer; and Thad Huston, our Chief Financial Officer. This morning's press release, slide presentation and conference call include forward-looking statements. Forward-looking statements may be identified by the use of forward-looking terminology, including, but not limited to, may, believe, will, expect, anticipate, estimate, plan, intend and forecast, or other similar words. Statements are based on information presently available to us and assumptions that we believe to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties. Our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks and uncertainties and other factors that are in some cases beyond the company's control. For detailed discussions of the factors that may cause our actual results to differ, please refer to our most recent filings with the SEC and other regulatory filings. Included in the press release today are selected non-GAAP operating results. In this press release, management has disclosed financial measurements that present financial information not necessarily in accordance with generally accepted accounting principles, or GAAP. Company management uses these measurements as aids in monitoring the company's ongoing financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against other medical technology companies. Non-GAAP financial measures used by the company may be calculated differently from, and therefore, may not be comparable to, similarly titled measures used by other companies. These non-GAAP financial measures should be considered along with, but not as alternatives to, the operating performance measures as prescribed by GAAP. Please refer to the financial tables provided in the press release that reconciles such non-GAAP measures to directly comparable financial measures presented in accordance with GAAP. To enhance the call, we have 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 in the Investor Relations section of our website under News & Events, Presentations at www.livanova.com. In just a few moments, Damien will be discussing net sales results for the quarter. In our press release, we provide a table that shows both reported net sales growth and constant currency growth so you can see the impact of foreign currency fluctuations. For discussion purposes, our comments on net sales growth during opening remarks will be expressed in constant currency. And with that, I will now turn the call over to Damien.

Thanks, Karen. Welcome to our fourth quarter and full year 2017 conference call. 2017 was a busy and, I should say, exciting year for LivaNova. We made significant advancements in many areas of our business as the year progressed, which is evident in our strong second half performance. For those of you that know the management team world, we take our commitments very seriously and take pride in doing what we say we're going to do. For the full year 2017, I'm extremely pleased to tell you that we met or exceeded all of our financial projections for the year. I'm going to walk you through some of the highlights in the fourth quarter and full year, discuss our sales results by business. And after my comments, Thad will give you some more color on financials and 2018 guidance. Then I'll wrap up with some closing comments before we move to Q&A. Starting with the key events from the fourth quarter of 2017. Early in the quarter, we announced FDA approval for our SenTiva VNS Therapy system, a next-generation programmer. Together, the components of a patient with drug-resistant epilepsy, a smaller, smarter and faster recovery device with enhance personalized features. We launched the product in the fourth quarter, and initial demand and interest for the device has been high. I'll spend more time discussing that with the detail during our sales discussion. When we announced that we -- we also then announced we entered into a binding letter of intent to sell our CRM business to MicroPort Scientific Corporation. We believe this transaction will be favorable for all parties involved. For MicroPort, the transaction allows them to strengthen their global presence. For LivaNova, it allows us to focus on our areas of leadership and strength, cardiac surgery and neuromodulation. The…

Thank you, Damien. I'm going to discuss the fourth quarter financials in greater detail and provide 2018 guidance. Since our 2017 guidance included CRM, I will comment both on the full year financial numbers with CRM as discontinued operations, and the financial numbers including CRM, so there's a direct comparison to our 2017 guidance. As Damien mentioned, sales growth from continuing operations in the fourth quarter was very strong, showing 8% growth. For the full year, sales growth from continuing operations was 4%. Including CRM, sales growth was 2.8%, reaching the high end of our projected range of 1% to 3%. Adjusted gross margin as a percent of net sales in the quarter was 64%, down 30 basis points from the fourth quarter of 2016. Increases resulting from favorable product mix were offset by more than 100 basis points impact from foreign currency. For the full year, adjusted gross margin as a percent of net sales was 66%. Including CRM, adjusted gross margin as a percent of net sales was 65%, falling in the middle of our projected range of mid-60%. Adjusted R&D expense in the fourth quarter was $31 million compared to $20 million in the fourth quarter of 2016. R&D as a percent of net sales was 11%, up 8% in the quarter -- in the fourth quarter of 2016. This is in line with our expectations that we highlighted to you last quarter, which is that you would see an uptick in clinical spend in the fourth quarter, both for our TMVR and heart valve program. For the full year, adjusted R&D as a percentage of net sales was 9%. Including CRM, adjusted R&D as a percent of net sales was 10.5%, aligned with our projection of 10% to 11% for the full year. Adjusted SG&A for…

Thanks, Thad. We were very pleased to exit 2017 with strong momentum and to make the financial commitments that we laid out for you from sales to earnings. We made significant advancements as the year progressed. Our foundation is solid, and we have an abundance of growth drivers to advance the business. We expect to see strong contributions of this year from our key products: our newest VNS Therapy system, SenTiva; our S5 heart-lung machine; our heart valve, Perceval; and our INSPIRE oxygenator. We are on-track for second quarter close of the sale of our CRM business to MicroPort. We are integrating ImThera in the Neuromodulation business, focusing near term on growing the European market, while we complete our FDA clinical trials in the U.S. We are working to close the TandemLife acquisition, whose advanced chronic pulmonary devices are highly complementary to our Cardiac Surgery business. And we're investing in our future, funding clinical trials and registries for our strategic portfolio initiatives, transcatheter mitral valve replacement, treatment-resistant depression and heart failure. We have provided 2018 guidance, which highlights both top line and bottom line growth, increasing margins and cash flow improvement. We have a clear road map for value creation and are well positioned to deliver on our commitments to drive shareholder value. And with that, Casey, we're ready for questions.

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

Wonder if I can maybe start on the margin side. The operating margin guidance for 2018, it's down a bit from where you were in 2017. Tax rate gives you a little bit of leeway there, but I'm curious about that trajectory. I think previously, you've talked about in this kind of 100 basis points in Europe operating margin expansion over the near term. And so what's the change in thinking there?

Raj, great to hear from you, and thanks for the question. We are very much aligned to what we were projecting before. I mean, we clearly see a focus on improving gross margin, roughly 100 basis points. We also talked a lot about our increase in R&D investment, which you saw in the fourth quarter, which will carry into 2018. So maintaining our overall kind of level of operating margin. But on the net income, we did see an improvement in our tax rate as well.

We're not backing off what we talked about at Investor Day, which was to get from the mid to high teens, which I think we did quicker than anyone anticipated that and into the 20s. And so we're continuing to guide that way as a long-term guidance from Investor Day, so we're not really backing off, but we're also executing on what we said, which is on the R&D investment.

In the quarter, we saw 100 basis points impact of foreign currency, which caused our gross margin to come back a little bit. But clearly, we seeing a continued focus on pricing and mix. It's very positive as we go forward.

That's helpful. Maybe just my second question, I'd ask about TandemLife. I guess if you look at the history of that company, the products never really got much traction. The procedure was difficult, the was quite large. You guys paid a fair price for that product and it sounds like you have high expectations going forward. And so perhaps you could maybe just give us a little bit more about what gets you so excited about the prospects for the new products, where the previous product from the company didn't really get a lot of commercial traction.

Yes, that's great question. I think this is a classic example of a company that was pivoting from some underinvestment. And the current team, I think, have done a good job of realigning the company and getting the portfolio strategy going. So that's really their focus for the last several years. And it's a classic example of a low revenue company being in cash constrained. And I think in our portfolio, we can take their low revenue, which by the way, is growing at 45%, and put it into our system and get behind some of their R&D pipeline, which I think is pretty exciting. It's not very visible yet, but what we have as an opportunity I think with near-term growth is exciting, but also what they have in the pipeline. And so between those two things and putting into our system, that's why we get excited.

It's very much in line with what we described before with our M&A strategy and fitting into our Cardiac Surgery pipeline, but also near-term accretive, driving revenue growth for the foreseeable future. So we really like it and it is very much a U.S. asset, so we think that there's a great opportunity for us to expand globally.

Your next question comes from Matt O'Brien with Piper Jaffray.

This is JP [ph] on for Matt. I want to first start with the TMVR program. It's a minor delay of three months, but you have some learning's from your initial patients so I was trying to get a little more detail there on what your initial learning's and what actions you're looking to improve that product?

Great question and pick up. We've always talked about this as being a feasibility study, and those sort of study, the learning opportunity. And we took a step back and said there are some things, when we got the feedback from some of our operators and clinicians that they said would really help advance. And mostly, that had to do with the handling of the delivery system, a little bit about the anchoring and how we anchor the device, which is a unique aspect of the product. And also, we wanted to make sure we've done enough to look at the training for the imaging and what was required for getting the positioning right in the first place, which is a really key aspect of it. And the imaging aspect of this is advancing pretty rapidly, so we learned a lot in the last three months. In addition, we also -- we're working a lot on these two additional valve sizes. And so a lot of the focus has been on getting those new products into the mix as well. And so if you wrap it all up, we thought that pausing while we did that and taking this 3-month delay early on was important. And as we've said, we'd rather be right than first, and patient safety is the big thing here for us, so we put all that learning into this refilling.

That's very helpful. And then I had to ask one on the cardiopulmonary business. That was much stronger than we had expected in the quarter. And it looks like, in terms of guidance, it's going to be contributor there. Specifically on the S3 to the S5 upgrades, can you help us frame out where you are in terms of upgrading your, maybe your current install base with industries or how long this tailwind of the S5 introduce can last?

Look, I think we've got some really great leaders who have come on board here who put in place what we referred to earlier as funnel management. And the visibility to that funnel has been really what's driving this. And we see 12 to 18 months of really great conversion opportunity across all of our geographies. It's not something we focused on previously, it wasn't visible to us. And putting those processes in place has been a really good d effort by all three of the regional sales teams, and I really applaud them for their change in behavior and process because it opened up a whole quarter of activity for us that previously not visible. So great runway, good visibility, and I'm excited about what I think the team can do.

[Operator Instructions] Your next question comes from Jason Mills with Canaccord Genuity.

Can you hear me okay?

Yes, Jason, and thank you for the Valentines note.

Decent, title, I guess. It is really is on the progress. I guess, I want to start as well with Tandem. Couple of questions there. One, I know you're initially focused, Damien, on the right heart failure and the opportunities look like they have some growth potential to them. But longer term, I think investors are interested in the pipeline. There might be something to compete with which is obviously, one of the more successful medical devices of our recent time. Could you talk about that? And given this looks like it shouldn't have any problems closing, at least from the outside looking in, I'm wondering why you're not including at least the guidance for the second half of the year? And perhaps you can give us some framework on what sort of acquisitions in our earnings line we could see from this business, just a rough numbers if possible.

Lo, I'll take that one. On the expansion of opportunity, I'm not going to be glib intentionally, but stay tuned. I think, look, the first thing is we got that asset. We're still working through that. And secondly, we have this really great near-term opportunity that, again, I think it's been really underexploited. And I think our focus is going to be on that right heart with ECLS. And then once we get into our system and into our accelerated product development processes, then we can look at taking on other indications and opportunities. But I think that's first land the ship and get it on board. Secondly, in terms of that guidance, again, if you want to jump in.

Look, to me, we haven't enclosed it yet. And so we have a lot going on this quarter. Obviously, both this ops treatment of CRM, we've acquired two businesses in 2017. We thought it will be prudent to kind of talk about guidance with TandemLife once we closed the deal. As I mentioned, the sales were $21 million in 2017, up 45% versus prior year. It's modestly profitable today and it has higher margins, which are higher on the gross margin side than what we have as a company average. So again, depending on when we close and will come back and give you more about on the financial impact.

And as we said, our intention is to find things that surround the core point or a diseased state and this tucks in perfectly to the cardiac team.

That make sense. I guess, for my second question, just given a lot of updates year on your pipeline. Maybe you could spend a minute and give us out of Iraq quarter, any way you'd like, sort of an assessment of your pipeline, which you've added to. So at the Analyst Day, you also talked about treatment-resistant depression, transcatheter mitral valves and heart failure. You've added a therapy component in our pipeline as well as now with Tandem, which you just talk about. Perhaps give us an update on your initiatives in and heart failure and how they fit in to your thinking, your spending plan for 2018 maybe over the next couple of years relative to the other things in your pipeline. Looks like you have sort of five buckets of initiatives now, not three, and just love to get your thoughts on your rank quarter?

Well, I think, clearly TandemLife is a near-term revenue, which is exciting for us. And so bringing that on an accelerating that is going to be a really key opportunity for us, both domestically in the U.S. and internationally. I think then, the timelines on case on ImThera really haven't changed. In heart failure, we funded that in our existing guidance. We're continuing to progress with that, and I'm excited about the opportunity there. So then, you get to TRD. And look, I think the recent act report was encouraging. I think what that shows is that TRD is both definable and treatable. We're continuing to have very -- and, I would say, progressive discussions with CMS on that. And we are encouraged by the opportunity there. We continue to believe that in terms of the patient response and a patient remission, this is a really great therapy. Our pilot in Germany is progressing, and we're seeing good early results there. So we hope that the TRD opportunity is something that's real. But again, as we've talked about, the processes with CMS are opaque. But we're trying to signal, we are prepared to invest in what it takes to have this patient population have a therapy option that's otherwise not available, and that's why things like the restore life registry is important. We're showing that we're investing behind this patient set. So again, if you think back to our Investor Day, look at those opportunities, very little has changed in what we were guiding then. And then we add in TandemLife and ImThera. I think what it really says, I hope everyone understands, so we have this great pipeline.

And we're investing for the future and delivering the present, which I think is really exciting and exactly in line with what we told everyone at Investor Day. The fact is the fourth quarter we said we're going to increase R&D investment, we did that. Going into 2018, we're exactly within the guidance and the ranges that we talked about before. And we now have -- what you pointed out, five really exciting opportunities in our pipeline that we're going to get behind.

[Operator Instructions] Your next question comes from Mike Matson with Needham & Company.

Just wanted to start, I guess, with ImThera. I know you give a little more detail and clearly, this is a huge market opportunity. But what I'm wondering is when you do start to commercialize that product, how are you going to sell it? I think it's probably a different call point in the call point your reps are selling to right now Neuromodulation. And then the guys that are part of the question, which is going to be around competition, how do you think this particular technology compares to the other product, I guess, the INSPIRE product, that's already FDA approved?

Yes. Two great questions. So on the call point, look, there's a lot of overlap here on this device. Firstly, technologically, we now had an electronic devices with a lead, and that's why we are working aggressively to combine this with our Neuromodulation platform. But a lot of the implanting of this will be with ENT surgeons, and a lot of ENTs already place the VNS device with drug-resistant epilepsy. So there's more to learn and build up the call point around the sleep centers, but that's something we believe we're prepared to invest in and that we have line of sight on. So I think we have an overlap on the call point for implanting, and we're working on the visibility to how we build out the commercial side on the sleep set centers. Look, in terms of competition, here's what I think. Firstly, I wish INSPIRE every success and hope that they are successful and all sorts of aspects of their business and the reimbursement side as well. But here's what we think. We have a simpler procedure. We have one lead versus two, which there are obvious implications to that. It's less patient pain, there's quicker patient recovery. And we think we're in a very good spot with our product versus the competition. And that's why we were bullish on the acquisition.

Okay, thanks. And just one on M&A. So one, you've done a few deals now or should we expect more. And two, if you look at the types of deals you've been doing, I guess the way I would classify them is sort of either near commercial or early commercial launch products. Is that kind of the MO here that you're expecting to [indiscernible]?

No. Look, we found 2017 to be a really transformational year. I mean, one, that's a good divestitures of CRM, and then to bring in three other assets is pretty remarkable. We want to continue down that trend and build out our platforms in Neuromodulation and Cardiac Surgery, and we're going to keep going. But I agree with you, it would likely be near-term smaller acquisitions that we can easily bolt-on or integrate within our Company.

[Operator Instructions] And there are no final questions coming in queue. Ladies and gentlemen, thank you very much for joining today. This concludes today's conference call, and you may now disconnect.

Thank you.

Thanks, everyone.