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Boston Scientific Corporation (BSX)

Q3 2017 Earnings Call· Thu, Oct 26, 2017

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Boston Scientific Q3 2017 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, this conference is being recorded. I'd now like to turn the conference over to Susie Lisa. Please go ahead.

Susan Lisa - Boston Scientific Corp.

Management

Thank you, Stacy. 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 Q3 2017 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 Investors/Filings/Quarterly Results and non-GAAP reconciliations. The duration of this morning's call will be approximately one hour. Mike will provide strategic and revenue highlights for Q3 2017; Dan will review the financials for the quarter, and then Q4 2017 and full year 2017 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, operational revenue growth is defined as excluding the impact of foreign currency exchange rates. Organic revenue growth is defined as excluding the impact of changes in foreign currency exchange rates and sales from the acquisitions of EndoChoice and Symetis over the relevant prior year period. In Mike and Dan's remarks, all references to growth are on an organic year-over-year basis unless otherwise specified. 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 and 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 Q4 and full year 2017 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.

Michael F. Mahoney - Boston Scientific Corp.

Management

Well done, Susie. Good morning, everyone. Boston Scientific delivered strong results, again, in third quarter 2017 with both revenue and EPS coming in at the high end of our guidance range despite a 9% organic revenue growth comparison in Q3 2016. Operational revenue growth of 6% and organic revenue growth of 4% reflects strong execution by our global teams and the success of our category lead strategy. We leveraged the 6% operational revenue growth in the quarter to deliver a 16% adjusted EPS growth, or $0.31 per share, which is the high end of our guidance range. Also, if you exclude the $0.02 negative impact of foreign exchange, adjusted EPS grew 23% year-over-year. This EPS growth reflects an 80 basis point year-over-year improvement in adjusted operating margin to 25.1%, led by a solid 72.2% gross margin and the 100 basis point reduction to year-over-year in SG&A spending to 35.2% of revenue. We're also excited about our plans to close out 2017, build upon our global momentum and drive sustainable long-term growth in 2018 and beyond. We're also narrowing our full-year 2017 operational revenue growth guidance to an estimated 7% growth, which includes an approximate 120 basis point full-year impact from the EndoChoice and Symetis acquisitions. We're also narrowing our full-year adjusted EPS guidance to $1.24 to $1.27, which represents 11% to 14% earnings growth. This revised adjusted EPS guidance includes an expected $0.07 to $0.08 negative impact, or approximate 700 basis point headwind, from foreign exchange. I'll now provide some highlights on third quarter 2017 results and thoughts to finish out the year. We continue to grow faster than market in most all of our businesses and regions. We also delivered consistent organic revenue growth in every geography, led by 8% growth in AMEA, 5% in Europe, and 3% in…

Daniel J. Brennan - Boston Scientific Corp.

Management

Thanks, Mike. Third quarter consolidated reported revenue of $2.222 billion represents 6% growth on a reported and operational basis, which excludes the impact of changes in foreign currency and is at the high end of our guidance range of 5% to 6%. Our reported revenue reflects a $3 million headwind from foreign exchange, which is $17 million or approximately 80 basis points less than the $20 million headwind expected at the time of guidance. Further, excluding the 140 basis point contribution from acquisitions, organic revenue was at the higher end of guidance with 4.3% growth. Although immaterial to the quarter overall, our revenue growth reflects a modest impact in the 10 basis point to 20 basis point range from the hurricanes in the quarter, which impacted procedures. Our thoughts are with those impacted by the hurricane and I'd like to reiterate Mike's thanks to our employees for their winning spirit, particularly on their ability to serve the needs of customers and patients throughout the many weather-related challenges this quarter. We delivered Q3 adjusted earnings per share of $0.31, also at the high end of our guidance range of $0.29 to $0.31, and representing 16% year-over-year growth. This double-digit adjusted earnings per share growth was driven primarily by the strong sales growth and P&L line item metrics that were in line with our guidance ranges. Adjusted gross margin for the third quarter was 72.2% compared to 72.5% in Q3 last year and, significantly, includes a year-over-year negative 120 basis point impact from foreign exchange, which is 40 basis points more than our guidance of 80 basis points. Revenue benefited from the euro strengthening, but since we are largely hedged for 2017, there is little corresponding benefit in gross profit, which negatively impacts the gross margin rate. Adjusted gross margin for the…

Susan Lisa - Boston Scientific Corp.

Management

Thanks, Dan. Stacy, 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. Stacy, please go ahead.

Operator

Operator

And we'll go to Mike Weinstein from JPMorgan. Please go ahead. [Technical Difficulty] (28:46-30:47)

Operator

Operator

Pardon me. We'll go to David Lewis with Morgan Stanley. Please go ahead. David Ryan Lewis - Morgan Stanley & Co. LLC: Can you hear me?

Susan Lisa - Boston Scientific Corp.

Management

Yes. (30:54) David Ryan Lewis - Morgan Stanley & Co. LLC: I am the lucky winner. Okay. So, let me kick it off here with a couple questions. Maybe I'll just keep asking, because I'm the only one who can talk. But just two questions, one for Dan and one for Mike. So, Dan, a couple things. You did bring up momentum improving in the fourth quarter. I just wonder if you could highlight what gets better. And you also shared with us at Analyst Day some specific commentary for 2018: 5% to 7% top, 50 bps of margin, $300 million non-op. Just want to know if there's any changes to 2018 assumptions you provided at Analyst Day, and then a quick follow-up for Mike.

Daniel J. Brennan - Boston Scientific Corp.

Management

Sure. I'll start with the second one. No update to that. We obviously have not issued guidance yet for 2018; would expect to do that in early 2018. So those numbers that we had given as goals at Investor Day are still good. Relative to Q4, we've guided to Q4 organic revenue growth of 4% to 5%, so the midpoint is 4.5%. So yes, there is, I would say, a slight acceleration if you take the midpoint of our range at that 4.5% versus the 4.3% we posted in Q3. But really, the key point to note is the comp, as we mentioned. The growth comp for Q3 was 9% and it's a little bit over 10% in Q4, so I think that gets at the acceleration portion for Q4. Broadly, the biggest driver from Q3 to Q4 is CRM. We don't expect to be down 1% in CRM in the fourth quarter, especially with the momentum of the RESONATE launch and our MRI safe defibrillator portfolio in the U.S. So, I'd say that's probably the biggest driver of the momentum from Q3 to Q4. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay. Very helpful. And then, Mike, just want to clarify some things on LOTUS. So, the slight delay into the first quarter, you talked about platform enhancements. So, how much of this is – is it new platform enhancements, additional required documentation or is it simply a longer than expected standard process for Europe? And just U.S. PMA timing, is approval mid-2018 still a decent estimate? Thanks so much.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes, I'll start with the second one. Yes, we haven't changed our timelines for U.S. approval to be mid-2018. So, we stay on track for that. There's a potential that the actual submission may slip into January, but we're comfortable with our timeline for approval mid-2018 and launching and starting to see a nice impact in the U.S. second half of 2018. No. In Europe, it really comes down to very small minimal impact to our overall business in Structural Heart franchise. And so what we want to do is ensure as robust a possible manufacturing and quality control process, given the importance of the platform, and we're just continuing to take a long-term view of this. And depending on the review time needed by the European regulators, we expect to launch LOTUS Edge in Europe in first quarter 2018. So, the bulk of it really is ensuring sound manufacturing and quality control, and we estimate a first quarter 2018 launch. David Ryan Lewis - Morgan Stanley & Co. LLC: And Mike, were there any changes to the device inter-quarter that necessitated this move?

Michael F. Mahoney - Boston Scientific Corp.

Management

No, we haven't made any technical changes beyond the pin pull fix that we've discussed. It's more scalability of our operations and supply chain and quality capabilities. David Ryan Lewis - Morgan Stanley & Co. LLC: Great. Thank you very much.

Operator

Operator

Thank you, and we'll go to the line of Mike Weinstein with JPMorgan. Please go ahead.

Michael Weinstein - JPMorgan Securities LLC

Management

Perfect, can you hear me okay?

Susan Lisa - Boston Scientific Corp.

Management

We can.

Michael Weinstein - JPMorgan Securities LLC

Management

Mike, just to follow up with that and flesh that out if you can, what are you referring to in scalability of the operations on LOTUS?

Michael F. Mahoney - Boston Scientific Corp.

Management

Simply, as we look at the – we talked about the end of the line QC testing that we've put in place that's automated, as well as testing along the lines of it in different increments, as well as ensuring we have the sufficient design builds for the number of devices needed for the PMA submission. So, it's design builds as well as enhancements to the quality control and scalability of the line. And so, with that, as said, we don't see a delay in our U.S. approval and we see potentially a 90-day delay in terms of our European launch.

Michael Weinstein - JPMorgan Securities LLC

Management

Okay. And so, the people just want to know what's the risk of another delay here happening. Do you just want to characterize that?

Michael F. Mahoney - Boston Scientific Corp.

Management

We feel comfortable with it. So, we haven't projected a delay to the U.S., which is the biggest market. We've exceeded our Structural Heart guidance, we estimate, for the year. The only impact, which we think is quite minor, is in Europe, which is potentially a 90-day delay. And so, we debated forever whether we should just say January or first quarter; we landed on the first quarter. So, we feel like a 90-day delay in Europe is an accurate date and we haven't delayed our U.S. launch. And in the meantime, we exceeded expectations with WATCHMAN as well as ACURATE.

Michael Weinstein - JPMorgan Securities LLC

Management

Okay. Let me – Dan, just one question on 2018. I heard your answer to David that – the dollar has moved since the June analyst meeting. You haven't gotten any benefit of that on the bottom line in 2017. Does that help you at all relative to that $0.05 headwind you called out for 2018?

Daniel J. Brennan - Boston Scientific Corp.

Management

Yes. Mike, I think that's a good point. As the rates have moved in 2017 and we're largely hedged in 2017, obviously, as we head into that year, we haven't seen a benefit. And actually, from a gross margin rate perspective, we've actually seen it go the other way on us. I think it's fair to assume our hope is that if rates were to stay where they are that we might see a little improvement against that $0.05 that we gave you of negative FX at Investor Day.

Michael Weinstein - JPMorgan Securities LLC

Management

Okay. Thanks. I'll let some others jump in.

Michael F. Mahoney - Boston Scientific Corp.

Management

Thanks, Mike.

Operator

Operator

Thank you. And we'll go to Bob Hopkins with Bank of America. Please go ahead.

Robert Hopkins - Bank of America Merrill Lynch

Management

Great. Thanks for taking the question. So just to – sorry to beat the dead horse here on LOTUS, but it's obviously such a key pipeline for you. So, I'm just curious to see what exactly changed from your kind of previous guidance, like what exactly is causing this? Is it something that you guys have decided to do or is it something that's been sort of mandated by regulators that you have to do?

Ian Meredith, M.D., Ph.D. - Boston Scientific Corp.

Management

Perhaps, I can take that actually, Bob. This is Ian Meredith here. So, as you know, we are well out of the starting gate with the regulatory approval processes, both Europe and indeed for the PMA. We have the PMA submission in the U.S. We have two of the three modules already submitted, including the clinical module, and the clinical module is one that might be the normal stumbling block. That's out there. And the technical data, as Mike said, will be submitted by year-end or possibly in January, and we're just trying to meet the number of design builds to provide that technical information. In Europe, we're working very closely with our notified body to ensure LOTUS Edge notification of change reflects the regulator's requirements in advance of the new medical device regulation framework that will come into place 2019 to 2020. So, I think the timeline is in our hands and I think the processes Mike outlined before really characterize the minor delay.

Robert Hopkins - Bank of America Merrill Lynch

Management

Okay. Great. Thank you for that. And then, Mike, one bigger-picture question for you on a couple of issues that have been swirling around the last month or two. I'd love to get your view on the outlook for growth in your business in China, given some of the changes that have been going on in China, or proposed changes from a kind of a national pricing perspective. What's your outlook for China in light of those potential changes? And any update, also, on kind of the national coverage decision determination that'll be made in late November on ICDs? Thank you.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes. So, we continue to see very strong growth in China. We're up 18% in the Emerging Markets and over 20% growth in China, again. And really, our business in China is really being diversified beyond just drug-eluting stents. So, some of the pricing, tendering and so forth you see in drug-eluting stents potentially could have an impact on our price, which we've already baked in to lots of our guidance that we gave at Investor Day. But also, that's offset by volume as we continue to increase our commercial distribution reach, and now we're playing in tenders and provinces that we never had in the past. So, we think our volume and distribution reach will offset any potential price declines in DES in China. And then, we continue to register new products in complex coronary. But more importantly, we just continue to diversify beyond DES in China. WATCHMAN's doing quite well for us at nice ASPs. Our whole MedSurg business was very underweight there a few years ago. Now, Endo/Uro/Neuromod are gaining traction, as well as our PI business. So, we really don't see in our projections a change of our kind of 15% growth commitment coming out of the Emerging Markets over the next couple of years.

Robert Hopkins - Bank of America Merrill Lynch

Management

Great. That's very helpful. Thank you.

Operator

Operator

And we'll go to...

Susan Lisa - Boston Scientific Corp.

Management

Sorry, Stacy. One second. On the NCD, Ken?

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

Management

Yes, Bob. It's Ken. Just quickly on the NCD, we're looking forward to the revised national coverage decision. As you know, the existing NCD is quite old at this point and really sort of just hasn't kept up with professional society guidelines and appropriate use criteria. We have urged CMS reserve coverage for the currently covered patient populations, but also just to clarify reimbursement around some of the edge cases that got caught up in the DOJ investigation a few years back. And we're optimistic that the results are going to enable physicians to use the devices where appropriate and where indicated under current professional guidelines.

Operator

Operator

And we'll go to Rick Wise with Stifel, Nicolaus. Please go ahead. Frederick Wise - Stifel, Nicolaus & Co., Inc.: Hi. Good morning, everybody.

Michael F. Mahoney - Boston Scientific Corp.

Management

Rick. Frederick Wise - Stifel, Nicolaus & Co., Inc.: Mike, maybe start off with some (41:32), obviously, you called out your above plan commercial performance for ACURATE neo. Maybe update us, if you would, in a little more detail on the European progress in whatever way you like: number of countries you're in now, hospitals. Can you give us any sense of market share and maybe what's next in terms of product gains or clinical milestones? Just give us some updates there. Thank you.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes. Candidly, Symetis has outperformed our expectations, and its potential impact, globally, we're much more bullish on as part of our TEVR strategy, quite frankly, than versus we first acquired it. So today we're primarily in Germany and some of the Nordic countries, and we're expanding. We're getting out of some distribution arrangements that were previously set. We're working through that this year and early part of next. And we're enhancing our direct sales force with the Symetis platform. So, we'll seek to provide potentially more specific guidance on Structural Heart at the next earnings call. We'll detail out what our plans are for 2018. But essentially, we've been able to deploy the bulk of our Structural Heart commercial organization and clinical over to Symetis while we're enhancing the LOTUS valve and bringing that back to Europe in first quarter 2018, and Europe and U.S. approval by second half – second quarter next year. So, the valve is doing very well. And I think to speak to that, there was just an interesting article written yesterday in JACC Magazine, JACC, that maybe Ian can highlight a bit.

Ian Meredith, M.D., Ph.D. - Boston Scientific Corp.

Management

Yes. Thanks, Mike. Rick, we continue to be very excited about the progress of the ACURATE platform in Europe. And as you know, the SCOPE I trial, which is a randomized, multi-center, head-to-head trial comparing S3 versus ACURATE, is going extremely well in the countries that it's in. And indeed, it's on target to complete its enrollment by the middle of next year. The SCOPE II trial, which is a randomized, head-to-head trial against the Evolut R or PRO platform is also doing well, and we expect that to complete enrollment in the middle of the year. As well as that, Mike just mentioned there was a nice publication in JACC: Interventions (sic) [JACC: Cardiovascular Interventions], yesterday. Three German centers comparing head-to-head – non-randomized data, though – ACURATE versus S3, showing equivalent efficacy and safety with a significantly lower rate of pacemakers for ACURATE and overall excellent results. Of course, this is not randomized data, but it bodes very well to the results of the forthcoming SCOPE I trial and, more importantly, the planned U.S. IDE ACURATE trial in full – for all classes, the extreme high and intermediate risk, which is planned for the second half of next year. So, these data published yesterday certainly give us great insight into the likely – or potentially likely outcomes for both SCOPE I and the U.S. IDE trial. Frederick Wise - Stifel, Nicolaus & Co., Inc.: Now, that's real helpful. Just one follow-up on pacers. The 4% decline sort of stands out this quarter. Maybe I missed it, but remind us the issues here. Is it competitive dynamics, product approval timing, and just where are we there in terms of getting that back on track? Thank you.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes. So, Pacer for the quarter, we really anniversary – quite frankly, it's more of a comp issue. We've anniversaried some tough comps with the pacer growth that we had last year, and so we expect that to improve. But really, it was a comp issue for the quarter and it was offset by our strong growth in ICD, which is up 1% for the quarter, really being fueled by S-ICD. And the quarter really didn't reflect any Resonate benefit beyond what we saw in Europe – sorry, European's CRM business grew nicely on the heels of Resonate, which we will launch in – with earnest throughout 2018. Frederick Wise - Stifel, Nicolaus & Co., Inc.: Thank you.

Operator

Operator

And we'll go to Glenn Novarro with RBC Capital Markets. Please go ahead.

Glenn John Novarro - RBC Capital Markets LLC

Management

Hi. Good morning, guys. Can you hear me, okay?

Michael F. Mahoney - Boston Scientific Corp.

Management

Hi, Glenn.

Daniel J. Brennan - Boston Scientific Corp.

Management

Good morning, Glenn.

Glenn John Novarro - RBC Capital Markets LLC

Management

Great. Thanks. I want to focus on the ICD franchise. So, congratulations, you got MRI safe approved sooner than expected; at least, sooner than we thought. And if I go back to the impact of MRI pacing on your business – over a year ago, the business prior – your pacing business prior to MRI approval was declining, and then it started growing double-digits. So, wonder if you can help us think about how your ICD franchise should grow going forward now that you have MRI safe in the marketplace. And then, as a follow-up, at your analyst meeting back in June you talked about a replacement headwind for the U.S. ICD business for next year. Is that still on track, and can you remind us the impact for 2018? Thanks.

Michael F. Mahoney - Boston Scientific Corp.

Management

Sure. So, we're very bullish on our position, particularly in Defib, as we close out 2017 and enter in 2018. As we articulated, that Resonate platform not only offers that MRI capability, but we believe that HeartLogic, that Ken can probably detail out a bit more, is a highly differentiated diagnostic tool for heart failure physicians that we'll be doing a number of clinical studies on. Then, you combine it with a longevity benefit. So, I think we're really well positioned with Resonate and S-ICD to take share in Q4 as well as throughout 2018 in Defib, which is clearly – is the highest profit margin business within CRM versus Pacer. So, we don't expect this to have the same level of growth rates that we saw when we had the Pacer MRI, because we had this MRI compatibility strategy with our current ICD and CRT-Ds. But nonetheless, we do expect to grow faster than market in Defib and expect faster growth in fourth quarter and in 2018 than we saw in 2017 in that business. And that'll also be combined with some benefits of a – more of a tailwind in replacements, which we talked about being about 100 basis points to CRM. So, we think we're very well positioned in the high margin Defib business with S-ICD and Resonate, as well as the tailwind, and also our strength in the EP business, which is up 18% in the quarter.

Glenn John Novarro - RBC Capital Markets LLC

Management

Great. Thanks for taking my question.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes.

Operator

Operator

And we'll go to Larry Biegelsen with Wells Fargo. Please go ahead.

Lawrence Biegelsen - Wells Fargo Securities LLC

Management

Hey, good morning, guys. Thanks for taking the question. So, two for me. I wanted to start with – what struck me in the quarter was all of the regions except the U.S. accelerated on an organic basis. So, the U.S., I think, went from 7% to 2.8%. And I know you said weather was a pretty minor impact, but the amount of the impact, I think, was lower than some other companies have called out. And I guess my question is why the deceleration in the U.S.? And do you expect a benefit from Medtronic's issues in any business in the fourth quarter? And I had one follow-up.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes. We didn't really want to overplay the weather card. We thought it was kind of 10 basis points to 20 basis points in the quarter, so had some impact and – but our teams did a really nice job. It had some impact on procedures, clearly, in Houston and in Florida. But overall, I think it just shows the balance and strength of the company, that diversified growth across Europe and Asia-Pac, and also, particularly with Europe's growth, which was a 9% operational growth with a benefit of a number of our new platforms, with the Eluvia, the DES, and the DCB, with the Resonate platform launching more quickly in Europe, as well as the impact of Symetis, as well as the growth of EP; it was significant in Europe. And again, all those platforms are coming to the U.S. So it gives us a lot of optimism for the U.S. growth as we head into 2018, 2019 and 2020 on the heels of these platforms that are performing very well in Europe. So, will there be upside from Medtronic's challenges? I think all companies have had challenges with Puerto Rico, and I think our team's done a really good job of limiting supply outages and having terrific contingency plans and backup resiliency plans in order to minimize those impacts that you're maybe seeing more strongly from other companies.

Lawrence Biegelsen - Wells Fargo Securities LLC

Management

Thanks. And then, Ian, I wanted to ask you one question. When you were asked this a couple quarters ago about LOTUS versus Symetis and the share, I think you said you expect them to be roughly 50/50 and it might have taken some people by surprise. I'm just wondering, at this point, do you still expect it to be 50/50 or is Symetis maybe picking up more, in your view? Thanks for taking the questions.

Ian Meredith, M.D., Ph.D. - Boston Scientific Corp.

Management

Thanks, Larry. Probably, it's hard for me to comment fairly on market share. Obviously, you can see that ACURATE is doing very, very well in Europe. It's a very popular platform. I think it'll play out over time what the market share will be.

Lawrence Biegelsen - Wells Fargo Securities LLC

Management

Fair enough.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes. I guess it just speaks to why we acquired Symetis in the first place. And we've talked about it for a while. We think the data for Symetis is very compelling, and Ian articulated that in terms of its performance against the best valves that Edwards and Medtronic has. We'll have a trial that will report that out. So, we have a lot of confidence in the clinical capabilities of Symetis and we have tremendous confidence in the unique abilities of LOTUS. And so, combined in a $5 billion market, which is a very small number for us today, we think it gives us the most unique growth profile in Structural Heart combined with WATCHMAN. And we're in the – I think we're not even – we're probably in the top of the first inning, still, in terms of our LOTUS opportunity as well as Symetis.

Lawrence Biegelsen - Wells Fargo Securities LLC

Management

All right. Thanks for taking the questions.

Operator

Operator

And we'll go to Joanne Wuensch with BMO Capital Markets. Please go ahead.

Joanne Karen Wuensch - BMO Capital Markets

United States

Can you hear me okay?

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes. Good morning.

Joanne Karen Wuensch - BMO Capital Markets

United States

Wonderful. Good morning. I have two questions for you. The first one has to do with gross margins. The commentary at the Analyst Day would imply a 50 basis point improvement next year, but this year you're absorbing 120 basis points from the FX headwind. And with FX shifting, walk me through, please, why this wouldn't be better next year?

Daniel J. Brennan - Boston Scientific Corp.

Management

Well, obviously, we haven't given guidance yet, Joanne, relative to 2018. You're correct, it's 120 basis point headwind for the full year this year, and I think what's nice is that we basically will have offset that with operational improvements this year relative to the total number. So specific to next year, it's one of the numbers that'll add down to what we give for total guidance for operating margin and earnings per share and such for 2018. But the focus of the team relative to the operational improvements and the value improvement programs that we drive is alive and well. So, we'll need to sort that out relative to what FX will be next year. Again, the hope – as I mentioned to Mike Weinstein's question earlier, the hope is that with the rates where they are, we might see a little bit less of a headwind next year relative to the FX at the bottom line. But we'll give specific line item guidance when we give guidance in 2018.

Joanne Karen Wuensch - BMO Capital Markets

United States

Thank you. My follow-up question has to do with – sorry, another LOTUS question – LOTUS in the United States. Assuming the third module goes in at the end of this year or the beginning of next, what are the steps that you need to then take to get a timely mid-year approval for LOTUS in the United States? Thank you.

Ian Meredith, M.D., Ph.D. - Boston Scientific Corp.

Management

Well, once the PMA submission is completed, it will be just a case of answering any questions that are required to complete that submission. And it's just simply a process of dialogue with the FDA. We have frequent and very productive communication with the FDA. So, it's simply a process of meeting their expectations. There's obviously a timeline to the FDA approval process, and in that time we may be required to answer questions.

Joanne Karen Wuensch - BMO Capital Markets

United States

But taking it a step further, what about manufacturing, ramp, productivity, sales force training? All that will be set in advance, I assume.

Michael F. Mahoney - Boston Scientific Corp.

Management

Yes. Unfortunately, with the delays, we've had – we have commercial capability ready to go in the U.S. for LOTUS. They've been deployed elsewhere within our Cardiovascular team since they can't, obviously, sell LOTUS at this point. So, we have resources already established and we'll continue to strengthen and build upon that team. So, it won't be a commercial concern for us. And by the time we launch LOTUS in the U.S. at greater scale in the third quarter, we'll have been ramping up manufacturing significantly in the first half. So commercial capabilities and manufacturing should not be a concern for us when we launch in the U.S.

Joanne Karen Wuensch - BMO Capital Markets

United States

Terrific. Thank you very much. Have a good day.

Michael F. Mahoney - Boston Scientific Corp.

Management

Thanks.

Operator

Operator

We'll go to Matt Taylor with Barclays. Please go ahead.

Matthew Taylor - Barclays Capital, Inc.

Management

Hi. Thanks for taking the question. I wanted to ask one about the balance sheet and use of cash, given you gave us an update on the settlement today. Can you talk us through a little bit how you're thinking about using your cash flow going forward as you're now going to be kind of out from under this overhang?

Daniel J. Brennan - Boston Scientific Corp.

Management

Yes, Matt. I think we've been pretty public about that in the past, and I don't think that really the timing of the payment for the IRS settlement really changes that. It's M&A and returning cash to shareholders are our two most favored uses of cash. I think we've balanced that well over the last four or five years, while at the same time settling a lot of legacy litigation liabilities and such. So, as we look forward to 2018, 2019, 2020, think back to Investor Day, we had talked about 90-plus percent of our cash over the next three years being able to go towards M&A and share repurchase over that timeframe, where it's been kind of the reverse of that over the last three or four years. So, I would look for M&A and share repurchase over that timeframe. And from an M&A perspective, there's plenty of opportunities out there to support our overall strategy of category leadership. I think you've seen that this year with a couple of the more notable ones we've done with Symetis and Apama, and I'd look for more of the same.

Matthew Taylor - Barclays Capital, Inc.

Management

Thanks. And one follow-up, I just wanted to ask about your mitral program and how you're thinking about mitral options in repair and replacement? It's been a little bit of time since we've gotten an update there. Can you talk about what you have and if you need to add anything to the portfolio to be competitive?

Michael F. Mahoney - Boston Scientific Corp.

Management

Sure. So, our focus clearly has been on the TAVR platforms, as you know, with LOTUS as well as ACURATE, as well as our WATCHMAN. And we think the size of the TAVR market is well over $5 billion, likely. And the WATCHMAN market, every point of penetration is $250 million; and, we continue to press on clinical and portfolio advantages there. So, we've been investing in the mitral area more with our VC investments, some of which have not been disclosed. So, we're interested in repair as well as replace. And we've really done more work on that through VC investments that we've made as well as a few internal, organic R&D opportunities. So, more to come on that. It's an area that we're interested in. We do think it'll be a significant market. We do think it'll play out longer than TAVR, given that it's more fragmented. So, expect us to continue to enhance our capabilities in that area, but it's not as much of a priority versus our atrial appendage and TAVR programs.

Matthew Taylor - Barclays Capital, Inc.

Management

Okay. Thank you, guys.

Susan Lisa - Boston Scientific Corp.

Management

All right. Stacy, with that, we'll conclude the call. Thank you very much, everyone, for listening in today. Apologies for the technical issues and, Stacy, if you could please give the replay information.