Earnings Labs

Boston Scientific Corporation (BSX)

Q2 2018 Earnings Call· Wed, Jul 25, 2018

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Boston Scientific Q2 2018 earnings call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will be given at that time. As a reminder, today's call is being recorded. I will now turn the conference over to your host, Susan Lisa. Please go ahead.

Susan Vissers Lisa - Boston Scientific Corp.

Management

Thank you, Kevin. Good morning, everyone, and thanks for joining us. With me on today's call are Mike Mahoney, Chairman and Chief Executive Officer, and Dan Brennan, Executive Vice President and Chief Financial Officer. We issued a press release earlier this morning announcing our Q2 2018 results, which included reconciliations of the non-GAAP measures used in the release. We have posted a copy of that release as well as reconciliations of the non-GAAP measures used in today's call to the Investor Relations section of our website under the heading Financial Information. The duration of this morning's call will be approximately one hour. Mike will provide strategic and revenue highlights of Q2 2018. Dan will review the financials for the quarter and then Q3 2018 and full-year 2018 guidance, and then we'll take your questions. During today's Q&A session, Mike and Dan will be joined by our Chief Medical Officers, Dr. Ian Meredith and Dr. Ken Stein. Before we begin, I'd like to remind everyone that on the call, organic revenue growth is defined as year-over-year growth excluding the impact of foreign currency fluctuations and sales from the acquisition of Symetis, with no prior-period related net sales. Also of note, this call contains forward-looking statements within the meaning of federal securities laws, which may be identified by words like anticipate, expect, believe, estimate, and other similar words. They include, among other things, statements about our growth in market share, new product approvals and launches, clinical trials, cost savings and growth opportunities, our cash flow and expected use, our financial performance, including sales, margins, earnings, and other Q3 and full-year 2018 guidance, as well as our tax rates, R&D spend, and other expenses. Actual results may differ materially from those discussed in the forward-looking statements. Factors that may cause such differences include those described in the Risk Factors section of our most recent 10-K and subsequent 10-Qs filed with the SEC. These statements speak only as of today's date, and we disclaim any intention or obligation to update them. At this point, I'll turn it over to Mike for his comments. Mike?

Michael F. Mahoney - Boston Scientific Corp.

Management

Thank you, Susie, and good morning, everyone. We had a strong second quarter, as we continued to deliver on our commitments while further investing in our bright future. Boston Scientific's diversified portfolio and category leadership strategy continued to drive top-tier performance while also enabling us to continue to invest meaningfully in our future pipeline, both internally and via tuck-in M&A. In Q2, our team delivered 9% operational and 8% organic revenue growth, with excellent balance across our businesses as well as our geographic regions. Both MedSurg and Rhythm and Neuro grew 9% and Cardiovascular sales increased 6%, all on an organic basis. Similarly, Asia-Pac organic sales were up 9%, U.S. up 8%, Europe-Middle East-Africa 7%, and Latin America up 15%. Overall, emerging market sales grew 21%, led by excellent growth in China. We leveraged this worldwide 8% Q2 organic revenue growth to deliver adjusted EPS of $0.41, which includes a $0.06 tax benefit. Absent this benefit, our adjusted EPS would have been $0.35, representing 9% year-over-year growth and at the high end of our guidance range. And Dan will also provide more details on the tax benefit. Boston Scientific also continues to generate excellent cash flow with $558 million in adjusted free cash flow this quarter, representing a 37% year-over-year increase. We're excited about the second half of 2018 and beyond given our efforts to drive compelling and durable long-term growth with differentiated financial performance. As a result of our strong performance and confidence in our outlook, we're bringing up the low end of our full-year 2018 organic revenue growth guidance from our prior range of 5% to 7% to 6% to 7%. We're also raising our Structural Heart revenue guidance from $400 million to $450 million and guiding to Q3 2018 organic revenue growth of 7% to 8%. There's…

Daniel J. Brennan - Boston Scientific Corp.

Management

Thanks, Mike. Second quarter consolidated revenue of $2.490 billion represents 10.3% reported revenue growth and reflects a $37 million tailwind from foreign exchange, about half of the $60 million to $70 million tailwind expected at the time of guidance. On an operational basis, which excludes the impact of foreign currency fluctuations, revenue growth was 8.6% in the quarter. Sales from the Symetis acquisition contributed approximately 70 basis points, which was in line with our guidance. As a reminder, the operational Symetis contribution represents only a partial period, two months, for which there were no prior-period related sales, and the revenue from Symetis is considered organic as of June 1 of this year. The resulting organic revenue growth of 7.9% in the second quarter exceeded the high end of our guidance range of 5% to 7%, as we continue to realize the benefits of our portfolio diversification and category leadership strategy, evidenced by the outperformance across the majority of our businesses and regions once again. We leveraged this strong performance and delivered Q2 adjusted earnings per share of $0.41, which includes an $82 million non-cash benefit related to the finalization of our IRS stipulation of settled issues in the quarter. Absent this benefit, our adjusted earnings per share would have been $0.35, representing 9% year-over-year growth and at the high end of our guidance range of $0.33 to $0.35. Earnings were driven by a strong top line and solid P&L metrics, and notably includes approximately $0.01 of negative FX impact as well as a $0.01 charge for an impairment of certain of our investments, which I'll discuss in a few minutes. Adjusted gross margin for the second quarter was 71.3%, slightly below our guidance range of 71.5% to 72%, and represents a decline of 150 basis points year over year, due…

Susan Vissers Lisa - Boston Scientific Corp.

Management

Thanks, Dan. Kevin, let's open it up for questions for the next 30 minutes or so. In order to enable us to take as many questions as possible, please limit yourself to one question and one related follow-up, Kevin, please go ahead.

Operator

Operator

Thank you. The first question is from the line of David Lewis from Morgan Stanley. Please go ahead. David Ryan Lewis - Morgan Stanley & Co. LLC: Good morning and congrats on a good quarter. Just two questions for me, and I'll ask them all at once. The first, Mike, is more strategic for you and then a quick follow-up for Dan. But on broader M&A, Mike, I think most investors would have expected as your capital flexibility improves that M&A builds back half this year, more acutely in 2019, but we've actually kind of seen the opposite. You've been very active on M&A in the first half of the year, and I wanted you to share with us why you're so active in the first half of the year and what this now says in terms of increased activity into 2019. And then related is does the Claret strategy make sense if you're not going to be in the U.S. market with a TAVR valve for a couple of years. And that's sort of M&A. And then for Dan, just sustainability of some momentum, the two biggest businesses that broke trend this quarter, obviously, Neuromodulation and EP, kind of your confidence into the back half of the year those businesses can sustain that kind of momentum. Great quarter, thanks so much.

Michael F. Mahoney - Boston Scientific Corp.

Management

Sure. Thanks, David. On the M&A front, first comment is our team has really developed excellent capabilities to execute on our integration acquisitions. If you look at the history of what we've acquired the last four or five years, the more mature companies are growing faster and driving more leverage in our hands, and we've been able to bring the newer companies along to successful completion, like ACURATE valve and so forth. Secondly, on the M&A front, this is not a new strategy for us. We've been very active in our venture fund over the past five years. We've really set the stage for these strategic acquisitions over time. So many of these acquisitions were planned and many of these we actually have an ownership stake in them. So the companies that we're tracking we're very comfortable with. And I think the third point is it really just continues to reinforce our strategy. We want to have a differentiated growth rate, differentiated financial performance, driving category leadership, and these variety of tuck-in deals all support that strategy. They leverage capabilities that we have today. They enhance our growth profile, and the discipline of the company is such that we can deliver on these acquisitions and also continue deliver operating income margin and double-digit EPS growth while importantly further enhancing our growth profile. So we have a lot of confidence in these. These are well planned, and we expect this strategy to continue.

Daniel J. Brennan - Boston Scientific Corp.

Management

And then, David, relative to your second question on sustainability in Neuromod and EP growth rates from a revenue standpoint, you happened to pick on two of the highest growth markets we have. Those are both very high-growth markets, probably two of the hottest ones we have in the portfolio. If you look at EP, last four quarters, 18%, 18%, 11%, and 16%. So that's kind of at market, which is okay. We'd like to grow better than that and we have new technologies coming. You've also seen as you look at the M&A strategy, three deals in the last 12 months relative to category leadership in EP, so we're investing in that space and we want to continue to drive growth there. So if you consider that market to be mid-teens, we'd like to certainly be at that or above as we go forward. Neuromod, 31% in the quarter is a real testament to the strength of the portfolio there. With WaveWriter and with DBS launching in the U.S., hard to imagine we put up 31% every quarter but we put up 17% in the first quarter, and I think said very publicly we think that's probably the low watermark for the year. So I would like to think we're north of 20% for the foreseeable future next couple of quarters. So two good businesses with strong growth prospects that we think should continue in the near-term. David Ryan Lewis - Morgan Stanley & Co. LLC: And, Mike, does Claret make sense? Just to follow back up on that, does Claret make sense if you're not going to be in the U.S. market with a TAVR valve in the next two years?

Michael F. Mahoney - Boston Scientific Corp.

Management

Claret makes great sense. Ian can comment, but the risk of stroke, not only in TAVR procedures, for intermediate risk, low risk, we've seen high percentages of their procedures have debris. And it's just an excellent complement to our current platform in Europe with ACURATE, and ideally would be the perfect platform for a potential combination of both LOTUS and ACURATE in the U.S., assuming we get through the much discussed technical and regulatory hurdles that we've talked about. So not only within TAVR does it make sense, but also expanded beyond TAVR and other procedures like I mentioned in mitral as well as EP procedures is a nice strategy for us. It leverages our current sales force. They have strong clinical data, and we think it's a really nice complement. Ian, do you have anything? David Ryan Lewis - Morgan Stanley & Co. LLC: Thanks so much.

Operator

Operator

All right, the next question is from the line of Glenn Novarro, RBC Capital Markets. Please go ahead.

Glenn John Novarro - RBC Capital Markets LLC

Management

Hi, good morning, guys, two questions. First for Dan, the EPS guidance that you maintain of $1.37 to $1.41, does that assume – for 2Q, does that assume $0.41 or $0.35? And the reason I'm asking is if I plug $0.41 into the model and given what you've provided for 3Q and revenue guide for the full year, it looks like there will be a step-down in EPS. And if so, is the EPS step-down a function of a higher tax rate, or is that where you're seeing all the dilution coming from the recent deals? Thanks.

Daniel J. Brennan - Boston Scientific Corp.

Management

So to be 100% clear, there is no step down in EPS guidance. The guidance of $1.37 to $1.41, with the way you describe it, would include a $0.35 number for the second quarter. The $0.06 of the tax benefit that gets you to $0.41, the plan is to reinvest that, largely in the fourth quarter, so you have $0.06 more in Q2. Likely you'd see the other side of that in Q4, so the $1.37 to $1.41 is still the number and still represents double-digit adjusted earnings per share growth for the year.

Glenn John Novarro - RBC Capital Markets LLC

Management

Okay. So just to be clear, I should have $0.35 in the model that shows up for consensus, correct, in First Call?

Daniel J. Brennan - Boston Scientific Corp.

Management

Absolutely, the $0.41 is the reported number, but the $0.06 of tax will not be a benefit for the year. It will be in in Q2 and out in Q4.

Glenn John Novarro - RBC Capital Markets LLC

Management

Okay, very good, very clear. And then, Mike, I know you don't want to comment on LOTUS, but help us understand the job postings that we found recently on your website referring to the relaunch of LOTUS. Thanks.

Michael F. Mahoney - Boston Scientific Corp.

Management

I would encourage you to send your resume in to HR, Glenn.

Glenn John Novarro - RBC Capital Markets LLC

Management

Okay. But shouldn't that assume that you're making further progress on the catheter fix?

Michael F. Mahoney - Boston Scientific Corp.

Management

We're not going to comment any further. We've said all along that our goal is to launch LOTUS in the U.S. and in Europe and getting over these hurdles, but we also have been through an up-and-down piece with this. So our commitment to our investors was that we wouldn't provide a specific date until the filing of the final technical module of the PMA is imminent or that we've chosen not to proceed. So we just basically don't want to give the blow by blow until this 100% over the goal line or not. In the meantime, the company is growing 9% operational and 8% organic, and our Structural Heart guidance we took up for the quarter. So it's our goal, but we're not going to give you a further update until it's over the goal line.

Glenn John Novarro - RBC Capital Markets LLC

Management

Okay, fair enough. Thank you.

Operator

Operator

Our next question is from the line of Rick Wise, Stifel. Please go ahead. Frederick Wise - Stifel, Nicolaus & Co., Inc.: Good morning, everybody. Maybe I'll continue on the TAVR front, Mike. ACURATE, the OUS performance you described is continuing strong. Can you quantify about it at all in dollars or percent? And maybe just talk as you answer about how broadly the products are available in Europe now, the potential impact of the ACURATE neo2 in terms of reaching more patients or facilitating more procedures. And I have a follow-up.

Michael F. Mahoney - Boston Scientific Corp.

Management

Sure. On ACURATE, I'm just really proud of the team. It goes back to David's question on our confidence and our ability to acquire companies and integrate them swiftly with our teams. And the team over in Europe has done a great job. We've managed the delicate balance of driving and maintaining the innovation of the company that we acquire but leveraging the global footprint that we have. And so ACURATE has exceeded our expectations. As you know, it's got an extremely low pacemaker rate, it's very easy to implant, and it continues to get wider visibility now that it has our commercial footprint. As you know, the bulk of the sales are in – call it the DOC [Denominazione di Origine Controllata] region; Germany, Austria, Switzerland, as well as the UK and the Nordics. We're not in France yet. We expect to be there I think by the end of 2019. And we're just now trying to expand ACURATE into other markets like Australia as well as Canada. So you'll see that ACURATE platform continue to – and also Latin America – continue to expand outside of the U.S. throughout the second half of this year and in 2019. And then in parallel, I'm really excited about the next-generation ACURATE neo, the combined improved PBL rate with the enhanced seal, with the best-in-class pacemaker right now, and ease of use. And then we finish up our SCOPE 1 and SCOPE 2 and hopefully initiate that U.S. IDE here in the second half. So a lot of momentum there, and combined with the potential dual-valve strategy and the complementary nature of Claret really makes a compelling TAVR portfolio for us. Frederick Wise - Stifel, Nicolaus & Co., Inc.: Turning to AF, Mike, you highlighted a number of milestones and targets. Maybe talk about the timing. I don't think you said it of the U.S. AF catheter launches. EU you said end of 2019, but U.S., is it 2020 or 2021? And are those launches the key inflection or a key driver that gets you to -- actually you are roughly at -- sustains you at or gets you to above-market levels of growth, or can you get there before with all the portfolio that you have? Thanks so much.

Michael F. Mahoney - Boston Scientific Corp.

Management

EP has been a strategic focus for us for a while. Five years ago, we essentially didn't have much of an EP business in terms of any innovation. And over time, we really believe that we'll have the most compelling portfolio in EP as you project out over the next few years. We're the only company with a modern mapping system, full therapeutic catheter launches, including pore sensing over time. And we're the only company with two shots on goal with single-shot therapy with cryo as well as with A-fib – with RF with our Apama balloon. So we think the portfolio is uniquely differentiated, and we're doing this because this market is so large. It's growing mid-teens, and we're currently growing at market, but we don't have the scale some of our competitors do. So we think the combination of that portfolio, and we'll have the single-shot balloons in Europe in the second half of 2019 and we'll launch the IDE trials in the U.S. in the second half of 2019 as well. So we think that combination, if you look at DSC over the next three years, we'll be uniquely positioned in EP. And where we grow in EP, we also do better in CRM. So it's also important for us from that perspective. Frederick Wise - Stifel, Nicolaus & Co., Inc.: I appreciate it. Thanks, Mike.

Operator

Operator

Our next question is from the line of Larry Biegelsen, Wells Fargo. Please go ahead.

Lawrence Biegelsen - Wells Fargo Securities LLC

Management

Good morning. Thanks for taking the questions, and I'll reiterate the congratulations on another strong quarter. First, I also wanted to start with a product question. I think the next big data presentation for you guys is the IMPERIAL IDE with Eluvia at hopefully I think TCT in September, and I think that study is comparing Eluvia to Zilver for PTX. So my question is do you think you need to show superiority in that trial for the product to do well commercially in the United States? And I had a follow-up question.

Michael F. Mahoney - Boston Scientific Corp.

Management

We'll have Dr. Meredith respond to that one.

Ian T. Meredith - Boston Scientific Corp.

Management

Thanks, Larry. I think the trial is designed on non-inferiority. And I think a lot about that question about superiority or non-inferiority, but I think that point estimate of the difference is something that physicians take home from those studies. So it's designed as a non-inferiority study, and there are obviously safety and efficacy endpoints. I think the data doesn't need to be a superiority study. It's important to look at point estimates.

Lawrence Biegelsen - Wells Fargo Securities LLC

Management

That's helpful. And regarding yesterday's ruling between Boston Scientific and Nevro, what does it say about your freedom to operate in the U.S. with paresthesia-free 10,000-hertz spinal cord stimulation? And what are your plans to present the ACCELERATE data? I think the slides say it's going to complete in 2018, so should we expect to see that at NANS [North American Neuromodulation Society] 2019? Thanks for taking the questions.

Ian T. Meredith - Boston Scientific Corp.

Management

Larry, perhaps I could take that one. As you know, the ACCELERATE trial is the study of the PRECISION spinal cord stimulation system and now the Spectra WaveWriter system, both modified to deliver high-frequency stimulation up to 10,000 hertz. The estimated primary completion date is being pushed out now from July 2018 to March 2019, and an estimated completion date for that will be between April 2019 and November 2019. This nine-month delay ensures that we can collect sufficient data on the Spectra WaveWriter system. Now, I might add, as you know, this is a randomized trial, and the primary goal of the ACCELERATE trial is to look at the impact of frequency on pain relief, where we now know that frequency is only one element. The pulse amplitude and other factors are also very important, and you know that we have both the WHISPER and PROCO studies, which have basically demonstrated that choosing between frequencies results in better outcomes. That's the WHISPER study, and the PROCO study was within subject comparison of multiple frequencies, showing that you could in fact actually get as good pain relief with 1,000 hertz versus 10,000 hertz and using significantly less energy and battery life to do that. So I think we're changing our view on what spinal cord stimulation patterns and frequencies need to be to cover both amplitude and waveform.

Lawrence Biegelsen - Wells Fargo Securities LLC

Management

Thanks for taking the questions, guys.

Operator

Operator

And our next question is from the line of Joanne Wuensch, BMO Capital Markets. Please go ahead.

Joanne Karen Wuensch - BMO Capital Markets

United States

Good morning and thanks for taking my question, very nice quarter. Two questions, I'll put them both out there. First of all, in cardiac rhythm management, it looks likes like there are some product gaps that need to be filled. And how do you think about filling those and what timing, and ultimately how do you view that business line?

Michael F. Mahoney - Boston Scientific Corp.

Management

Sure. In CRM, we really are on a high degree of offense in defibrillators. We don't see any product gaps there. And we have a lot of differentiation, primarily in two areas, with our S-ICD, which continues to drive double-digit growth globally, and we have a multiyear head start on that. And we continue to drive enhancements to that to improve procedures. And Ken can comment on it in a minute. It's just on the enhanced clinical body of evidence that continues to mount on that. So that's a long-term differentiator for us. The second one is our RESONATE platform with HeartLogic is taking share there. And we want to continue to focus with it more on CRT-D with that platform. So on defib, we're really in a very strong position. On the pacemaker side, we do have some product gaps with CRT-D pacing with MRI. We hope to fill that gap within the next – I guess fourth quarter this year. So that will be -- so we expect really the second half of this year to maintain pacemaker softness, but that MRI CRT-D gap will be filled by the end of the year. So likely you'll see in 2019 some improvement in our pacemaker capabilities. The only other gap that we have in pacemaker is the leadless platform, and those efforts are underway in combining a standalone leadless pacemaker and also uniquely differentiated combining our leadless pacemaker with our S-ICD. Maybe, Ken, you want to comment on that piece of it.

Kenneth Stein, M.D. - Boston Scientific Corp.

Management

Thanks, Mike. Again, Joanne, I think we're comfortable that it's our competitors who have gaps, particularly in the high-voltage arena. Mike mentioned S-ICD. We have the world's only ICD that does not require any leads touching the heart. And as you look to how that's evolving, I think Mike hit on something that we're very excited about, which is our EMPOWER leadless pacing system, which is going to go into IDE trials in 2019, which will include a trial designed to show that that can function as a run of the mill VVI pacemaker and close that gap, if you will, but also show that it can be capable of coordinating with and communicating with the S-ICD, creating, frankly, another product gap for our competitors and resolving what has been the residual anxiety people have had about using the S-ICD in primary prevention patients.

Joanne Karen Wuensch - BMO Capital Markets

Operator

Excellent. And as a follow-up question, I'm going very back to the beginning of Q&A. There's a lot of M&A that you're doing a lot faster than I and many investors, I think, would have expected. If we look forward three to five years, how do you big picture view the portfolio? How do you plan for building it out from here? And are there things you don't want to have anymore? Thanks.

Michael F. Mahoney - Boston Scientific Corp.

Management

Oh yeah, there's lots of things we don't want to have. So we note all that. So we have a very – I'm not going to share it on the call. We have a very thoughtful laid out strategic plan that we continue to modify some of the tactics and regions and by BU. We know very clearly what spaces we want to invest in, what adjacencies we want to invest in, and what areas we don't. And so it's very well laid out. And not surprisingly, if you look at these small tuck-in deals, none of these are significant and one-size. So they're tuck-in deals that all leverage capabilities that we currently have. They enhance the diversification growth profile of the company, and importantly, probably most importantly, tremendous confidence in our team's ability to deliver on them. And we've spread them out across the BUs and we work very closely with our operations team, and we still see a pipeline of future tuck-in deals over the next 12 months.

Joanne Karen Wuensch - BMO Capital Markets

Operator

Thank you.

Operator

Operator

Our next question is from the line of Robbie Marcus, JPMorgan. Please go ahead.

Robert J. Marcus - JPMorgan Securities LLC

Analyst · Robbie Marcus, JPMorgan. Please go ahead

Great, thanks and congrats on a good quarter. Dan, I wanted to start and follow up on the tax question. Do you mind spending a minute on where the tax upside will be reinvested in the fourth quarter? Is it all into the tax line, or is it throughout the P&L? Maybe talk about some of the mechanisms that will help lower the tax rate going forward in 2019.

Daniel J. Brennan - Boston Scientific Corp.

Management

Sure, Robbie. The short answer to that is it will all show up on the tax line, it won't show up in any other area of the P&L. And just to, again, I think probably worth recapping, so we finalized the 2001 to 2010 IRS settlement. There's an $82 million non-cash benefit to adjusted earnings in the quarter, $0.06, which is the difference between the $0.41 and the $0.35. Our current expectation is that we would reinvest substantially all of this benefit, likely in the fourth quarter. Therefore, there's no change to full-year adjusted EPS guidance. We've invested in our tax structure with the goal of reducing our tax rate 2019 and beyond. So recall our – we're on record now as saying we'll have an operational rate of 15% in 2019 and beyond. Goal would be to reinvest that in our tax structure, bring that 15% down. The way we would do that is – it's not a cash investment, so this is a non-cash benefit. And what we would do is monetize some of our existing deferred tax assets. And simply put, when you look at the world and the different tax rates around the world and where you earn your income and where you have certain presences, that's what we would evaluate is how do you do that to take that 15% and bring that down for the future. So hopefully that's clear. We'll be more disclosive as we go through Q3 and Q4 and enact those strategies. We're in the process of developing them now. But goal would be to take that $82 million benefit, reinvest it and bring down the 15% in 2019 and beyond, all on the tax line.

Robert J. Marcus - JPMorgan Securities LLC

Analyst · Robbie Marcus, JPMorgan. Please go ahead

Okay, great, and then just a quick follow-up. Emerging market growth, strong double digits this quarter. Maybe you can just talk about how sustainable that strength is, some of the health of the emerging markets and are you seeing an impact. And then maybe just give us your latest thoughts on any impact from China tariffs and the latest on the China price decreases this year. Thanks.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yeah. So this is a very good quarter with emerging market growth. As we laid out in our Investor Day a while ago, emerging markets will continue to be accretive to our overall growth profile. I think what you're seeing is just an increased commercial capability and portfolio enhancements, whether it be the emerging markets in Asia, Middle East-Africa, and also Eastern Europe. So all three of those regions performed well, China being the largest one. And so I think the capabilities of local team, the regulatory product approvals that we have, and also it's the diversification of the business. So in prior years, it was really a DES play only. So DES is still important for us, but it's diversifying into complex coronary capabilities. Peripheral intervention is growing extremely fast in emerging markets. We're expanding Endoscopy, Urology, and Neuromodulation. So it's the diversification of portfolio and just excellent work by the local teams. I think the other comment I'll just make broadly, maybe that we're most proud about is the diversification of the company. And five or six years ago, if you would have said DES is going to be down mid-single digits and CRM was going to be up 1%, you'd have a company at Boston probably growing flat. And we put up a 9% operational, 8% organic. And our R&D pipeline in combination with the tuck-in M&A are all reinforcing that category leadership strategy, diversification, and faster growth markets. So it's a much different company, and we're very confident in our ability to continue the momentum.

Daniel J. Brennan - Boston Scientific Corp.

Management

And just to tie off specifically on your China question, Robbie, so we don't manufacture in China. We do buy a small portion of our components. It's a small, very manageable percentage of our supply costs, have some ability to substitute in some other suppliers outside of China, so don't see a big impact there. In terms of the tariffs that are there, currently we don't see any medical devices in that tariff list, so I'm not anticipating a big impact there, and really nothing new on the China tender, so kind of status quo from where we've been the last six months, which is no real updates on that.

Operator

Operator

Okay, next we have Chris Pasquale, Guggenheim. Please go ahead.

Christopher Pasquale - Guggenheim Securities LLC

Analyst

Thanks, a quick one for Dan and then one for Dr. Meredith on Claret. Dan, can you just quantify the M&A dilution you're offsetting this year?

Daniel J. Brennan - Boston Scientific Corp.

Management

Yeah, it's a little north of $0.02, yeah.

Christopher Pasquale - Guggenheim Securities LLC

Analyst

Great, thanks, and then...

Daniel J. Brennan - Boston Scientific Corp.

Management

Just a quick comment on that. So none of them individually is that large when you see the press release is they're all overall immaterial on each one. It's just when you do that, the number we've done, and we're excited for the deals we've done it just aggregates to about $0.02.

Christopher Pasquale - Guggenheim Securities LLC

Analyst

Perfect, thank you. And then, Dr. Meredith, on Claret, do you expect to receive a new tech add-on payment for that technology when the IPPS final rule is released in a couple of weeks? And how do you think about the potential for adoption, either with or without that economic incentive for use? And then from a pipeline perspective, what are you more focused on? Is it iterating the technology or expanding the indications for use? I know there has been some question about whether leaving the left subclavian exposed might limit the efficacy of that particular device.

Ian T. Meredith - Boston Scientific Corp.

Management

Okay, thanks very much, Chris, for the question. First of all, as you know, there is an application for the NTAP in process, and we'll hear the outcome of that by the end of August, and it will be coming to effect if we receive that in October. But we are not dependent on that nor have we modeled that as that being critical to the uptake in the utilization. More than 100 centers in the U.S. are currently using the device, and it's up to 60% of cases in those centers using device. So I think physicians have essentially voted with their feet. As you know, the last 15 trials in a pooled registry have shown the stroke rate of around 4.5% in more than 8,000 patients, and half of those are disabling strokes. So I think physicians and hospitals are voting with their feet with respect to this. And obviously, the NTAP payment would be much welcome, but it's certainly not – we're not dependent on that. And as for expanding the indications, I think the first thing to say is to consolidate where we are in the TAVR market, and then obviously the iteration of the device to cover the left vertebral artery. Now does that really matter? Probably not significantly so, it accounts for less than 10%, probably 5% of the flow. The other vessels are more relevant. And of course, seeing that you've mentioned thereafter the indications for other uses, the mitral, left atrial appendage occlusion, and then high-risk PVI for AF ablation, because all of those procedures are associated with somewhere between 0.5% and 1.5% risk of stroke and a 20% to 40% occurrence of asymptomatic cerebral ischemic injuries on MR or other forms of neuroimaging. So I think that's the way it rolls out.

Susan Vissers Lisa - Boston Scientific Corp.

Management

Kevin, we'll take one more, please.

Operator

Operator

And that question is from the line of Bruce Nudell, SunTrust Robinson. Please go ahead.

Bruce M. Nudell - SunTrust Robinson Humphrey, Inc.

Analyst · Bruce Nudell, SunTrust Robinson. Please go ahead

Thank you for squeezing me in. I just have two questions. One clinical, one M&A-related. So on the clinical side, just to put a finer point on it, the result, Nevro put out a press release this morning saying they're still protected above 1.5 kilohertz. Without the debating the veracity of the statement, just given the day got to date showing of Nevro's response between 1 and 10 kilohertz, the improved battery efficiency, and the importance of waveform optionality, do you actually – is there any evidence that you really are going to have to go above 1.5-kilohertz? That's my first question.

Ian T. Meredith - Boston Scientific Corp.

Management

Bruce, that's a good question. And the reality is there's definitely a learning curve for the law of frequencies, but we have level-one evidence in that PROCO randomized trial. And we also have data from the WHISPER trial, and there are other studies like the NORTH study, three randomized controlled trials that showed that when properly delivered, 1 kilohertz provides excellent outcomes. But more importantly, as I said before, there are more things that determine pain relief, the optionality, the ability to use two waveforms simultaneously, a softer session, and a para-3 fib. So it is not all just about the frequency. There are other factors, amplitude, variability in amplitude, pulse sweep, duration, training. So there is really more to it than just the frequency.

Bruce M. Nudell - SunTrust Robinson Humphrey, Inc.

Analyst · Bruce Nudell, SunTrust Robinson. Please go ahead

Thanks. And my second follow-up is – or my follow-up is to Mike. Mike, you seem to be taking a very aggressive view in some of your acquisitions towards really getting heft in targeted areas. So in EP you bought Apama and you bought a cryo balloon one-shot. In BPH, you're exploring both embolization as well as the NxThera approach. Could you just talk about that strategy of really going after things in a very aggressive way?

Michael F. Mahoney - Boston Scientific Corp.

Management

I think I would recall it as very planful and smart because it is all planned. And as I mentioned before, many of these are companies that we already have investments in and we've been tracking for multiple years, so it's not ad-hoc. And I think the second thing is it just reinforces category leadership. We're the category leader in urology, but we didn't have an MIS play and we didn't want to spend $1 billion to acquire one. And so we felt NxThera is an excellent offering and very good for shareholders, and it creates strengthening category leadership in urology and expands our BPH beyond Greenlight. EP is a fantastic market that we're committed long term to. There are pull-through benefits to our large CRM business, and we saw an opportunity in the fastest growing segment, which is single-shot, to disrupt and be the only company to have both. And we see that segment growing likely plus 20%. And so we feel like that puts us at a competitive advantage in a fast-growth market with a differentiated portfolio that helps pull through. Same thing with Claret. We feel that Claret is a proven technology. It will have a revenue impact in the second half of this year and 2019 just like NxThera. So some of these deals will have revenue this year and next year, some of them are longer-term investments. But Claret, as Ian mentioned, is a perfect complement to our TAVR strategy, and there's upside in other indications in structural. So we think all of this reinforces category leadership in spaces that are high growth, that enhance the long-term growth profile of the company, and our team has excellent ability to execute on these.

Bruce M. Nudell - SunTrust Robinson Humphrey, Inc.

Analyst · Bruce Nudell, SunTrust Robinson. Please go ahead

Thanks so much.

Susan Vissers Lisa - Boston Scientific Corp.

Management

Great, with that we'd like to conclude the call. Thanks for joining us today and appreciate your interest in Boston Scientific. Before you disconnect, Kevin will give you all the pertinent details for the replay.