Boston Scientific Corporation
Q2 2016 Earnings Call Transcript

Published: 28 Jul 2016

[Operator:]

Ladies and gentlemen, thanks for standing by. Welcome to the Second Quarter 2016 Boston Scientific Earnings Conference 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 would now like to turn the conference over to your host, Susie Lisa. Please go ahead.

[Susan Vissers Lisa:]

Thank you, Greg. 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 2016 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 2016, Dan will review the financials for the quarter and then Q3 2016 and full-year 2016 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. Keith Dawkins and Dr. Ken Stein. Before we begin, I'd like to remind everyone that on the call, organic revenue growth is defined as excluding the impact of changes in foreign currency exchange rates and sales from the acquisition of the American Medical Systems, AMS, Male Urology portfolio over the prior-year period. 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 Q2 2016 results and Q3 and full-year 2016 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:]

Thank you, Susie, and good morning, everyone. We continue to beat our long-range strategic plan goals and execute very well as a global team. The success of our category leadership strategy is helping us gain share in our core markets, expand into faster growth adjacencies and deliver solutions that address unmet clinical needs. Our consistent results continue to demonstrate that Boston Scientific is uniquely positioned to deliver differentiated long-term shareholder value. With long-term visibility and mid-single-digit organic revenue growth, complemented by ongoing operating margin improvement initiatives, our goal is to consistently drive double-digit adjusted EPS growth. We're very excited about our excellent second quarter performance, first half results and most importantly our plans for the future. In Q2 we drove total operational revenue growth of 16% and organic revenue growth of 10%, excluding the impact of the AMS Urology acquisition. We had strong results across all regions, and five of our seven business units grew revenue double-digits organically. We've leveraged that revenue growth to drive adjusted operating income growth of 22%, resulting in an adjusted operating margin of 23.4%, a 130 basis point improvement year-over-year. We delivered adjusted EPS of $0.27, achieving the high end of guidance and representing 25% growth, including a negative $0.015 impact from foreign currency. So given our strong performance, we're increasing our 2016 guidance for revenue and adjusted EPS. We're increasing our full year organic revenue growth guidance from 6% to 8% to 8% to 9%. Full year operational revenue growth guidance, which includes the benefit of AMS, is increased from 9% to 11% to 11% to 12%. We're maintaining our full-year adjusted operating margin guidance of 24% to 24.5%, which at the midpoint is roughly 200 basis points of improvement over 2015. We're also increasing our adjusted EPS guidance by a penny over our prior range to $1.07 to $1.11, which represents 15% to 19% growth. Importantly, this adjusted EPS guidance includes an expected $0.05 negative impact from foreign exchange. I'll now provide some highlights on Q2 results and our 2016 outlook. In my remarks all references to growth are on a constant currency, organic, year-over-year basis and they exclude the benefit of AMS. Our second quarter revenue growth of 10% was broad-based across businesses and regions, led again by exciting new product launches, continued global expansion, and execution of our category leadership strategy. We drove double-digit growth in five businesses

[Daniel J. Brennan:]

Thanks, Mike. In Q2 we generated organic revenue growth of 10% versus our 6% to 8% guidance range and adjusted EPS of $0.27, representing 25% year-over-year growth and the high end of our guidance range of $0.25 to $0.27 cents. The strong adjusted EPS growth performance in Q2 was driven primarily by revenue growth upside and a lower SG&A rate versus prior year. And given the strong performance in the first half of 2016, we are again raising full year guidance for revenue growth and adjusted EPS. Consolidated revenue of $2.126 billion represented operational revenue growth of 16%, exceeding the high end of guidance and excludes the impact of a $24 million headwind from foreign exchange which was in line with guidance. Excluding an approximate 500 basis point contribution from the AMS Male Urology portfolio acquisition, organic revenue growth was 10% in the quarter and 15% on an as-reported basis. Adjusted gross margin for the second quarter was 70.7%, decreasing 60 basis points year-over-year and unfortunately 130 basis points below the midpoint of Q2 guidance due to a few factors that I will detail. The year-over-year decrease is due to the unfavorable impact of foreign exchange, which was a 120 basis point headwind as well as costs related to our new Malaysia manufacturing plant, the AMS integration, including the AMS quality remediation expense. Compared to guidance, the shortfall is due to inventory charges in advance of new product launches, inventory write-offs related to WATCHMAN FLEX and more unfavorable FX. We now expect Q3 and full-year 2016 adjusted gross margin to be in the range of 71.5% to 72.5%, which includes an expected 75 to 100 basis points of unfavorable foreign exchange. A key element in the second half increase is lower expected inventory charges, and we will also benefit fully from the lower 2016 standard costs of our products as we will have sold through all of the inventory valued at last year's higher standards. Adjusted SG&A expenses were $763 million or 35.9% of sales in Q2, down 140 basis points year-over-year. We continue to believe our full-year rate will be between 35.5% and 36.5%, which at the midpoint would be a 140 basis point improvement compared to last year. Adjusted research and development expenses were $222 million in the second quarter, or 10.4% of sales, which is down 50 basis points year-over-year. As a result of a slightly lower R&D rate in the first half, we expect our full-year 2016 adjusted R&D rate to be between 10.5% and 11.5% of sales, or 50 basis points lower than prior guidance. Royalty expense was 0.9% of sales in Q2, roughly flat year-over-year. Our Q2 2016 adjusted operating margin of 23.4% was in line with our guidance and represents a 130 basis point improvement over Q2 last year, which marks the eighth consecutive quarter in which we will have expanded adjusted operating margin by 100 basis points or more. As a reminder, we've signaled a sequential decrease in adjusted operating margin from Q1's rate as we experience the usual increase in SG&A from Q1 to Q2 due to seasonal trade show activity and began to ramp re-investment of the medical device excise tax suspension. Our first-half 2016 adjusted operating margin of 24.2% positions us well to achieve our full-year adjusted operating margin guidance of 24% to 24.5%, and we remain on track to reach 25%-plus in 2017. Q2 adjusted operating income grew 22% year-over-year, with all three reportable segments expanding adjusted operating margin by at least 170 basis points over Q2 2015. Specific to Rhythm Management, the team delivered an adjusted operating margin of 16.9%, up 280 basis points year-over-year. In the second half of 2016, we expect Rhythm Management adjusted operating margin to continue to improve and be 18% to 19%. This second half gain is expected to result from realizing the full benefit of 2016 product costs, leveraging the improved top-line performance expected of the global CRM and EP businesses, and we continue to believe Rhythm Management is on track to deliver an adjusted operating margin of 20% in 2017. Turning to the balance sheet, we had some key developments in the quarter that helped reduce future uncertainties. Before I get into the details of the activity in the quarter, let me try to frame out the next three years of expected cash flow at a high level. From 2017 through 2019, we believe we can generate cumulative adjusted free cash flow, after CapEx, approaching $6 billion. We expect to allocate roughly two-thirds of that $6 billion to a combination of M&A and share repurchases. As you are aware, the two most significant liabilities on our balance sheet are our IRS transfer pricing case and the mesh litigation. During the quarter, we took two important steps to manage these liabilities. First, we reached a stipulation of settled issues with the IRS for the 2001 to 2007 tax years. And importantly, this stipulation also provides a framework to settle the remaining years 2008 through 2015 as well. While there's work to do to conclude all the years, we are confident we will bring these to conclusion over the coming quarters. With a payment in 12 to 24 months, this would eliminate one of the most significant liabilities on our balance sheet. With regards to mesh, we increased our reserve by $608 million during the quarter. With the same goal of managing our liabilities, we've reached conditional or final settlements on 12,000 claims and made significant progress towards reaching agreement in principle on another 7,000 claims for a total of 19,000 claims. This represents approximately half of the roughly 40,000 known claims, and we expect to make even more progress during the remainder of 2016. As you know, every quarter we assess all four key components involving calculating the reserve and make any necessary adjustments for all probable and estimable charges, including the volume of known claims, the estimated cost to resolve each claim, an estimate of future claims and the cost to defend each claim. Our total legal reserve, of which mesh is included, was $2.375 billion as of June 30, 2016, and we believe it reflected our best estimate of what is probable and estimable. Of note as well is that included in this reserve is the Mirowski judgment which we have paid in full subsequent to quarter end. So as of today, the reserve would be closer to $2 billion. As a reminder, this $2 billion includes a number of claims we have agreed in principle to settle, but have not yet paid. Once those settlements are funded, the amount of the reserve will be adjusted accordingly. Now I'll move on to interest expense. Interest expense for the quarter was $59 million, compared to $106 million in Q2 of last year. The decrease is primarily due to the pre-tax one-time charge of approximately $45 million associated with the senior note refinancing in Q2 of last year. Excluding this charge, Q2 2016 interest expense was $61 million. Our average interest expense rate was 4% in Q2 this year, compared to 8% in Q2 last year. The lower interest rate expense in Q2 of 2016 was primarily due to lower average cost of debt resulting from the senior notes refinancing and the inclusion of the pre-tax one-time charge in Q2 of last year that I mentioned. Excluding this charge, Q2 2015 interest expense would have been 4.6%. Our tax rate for the second quarter was 47.8% on a reported basis and 14.2% on an adjusted basis. As reported last week, we're pleased with the conditional settlement reached with the IRS counsel regarding our transfer pricing litigation and plan to use some of the current benefit to repatriate overseas cash, thus we continue to expect our full-year 2016 adjusted tax rate to be approximately 14%. We believe this IRS settlement, in addition to recent progress we've made towards reaching agreements in principle to settle additional mesh claims as I mentioned, are prudent actions to take in the management of our balance sheet. Finally, Q2 2016 adjusted EPS of $0.27 includes approximately $0.015 of unfavorable FX and represents 25% year-over-year growth or 32% growth, excluding the impact of foreign exchange. On a reported GAAP basis, Q2 2016 EPS was a loss of $0.15 and includes net charges and amortization expense totaling $580 million after tax. Adjusted free cash flow for the quarter was $464 million, compared to $406 million in Q2 of last year. Given the strong adjusted free cash flow generation in the first half of this year, we are raising our full year adjusted free cash flow guidance from $1.5 billion to $1.6 billion, which was formerly our stretch goal. Achieving adjusted free cash flow of $1.6 billion would represent 17% growth, and we continue to pursue inventory management initiatives designed to improve the working capital contribution to cash flow. In Q2 we used cash primarily to repay $250 million of bank term loans as well as fund the previously agreed legal settlements. As of June 30, 2016, we had cash on hand of $438 million. Near-term, our capital allocation priorities are to manage contingencies and pursue tuck-in M&A. We ended Q2 with 1.375 billion fully diluted weighted average shares outstanding. Consistent with our prior guidance, we expect our share count to increase by roughly 5 million per quarter through the end of 2016 as we plan to keep the buyback suspended for the balance of this year. We expect this to result in a fully diluted weighted average share count of approximately 1.380 billion shares for full-year 2016. I'll now walk through guidance for Q3 and full-year 2016. For the full year we now expect consolidated revenue to be in a range of $8.270 billion to $8.370 billion, which represents year-over-year growth of 8% to 9% on an organic basis and 11% to 12% on both an operational and reported basis. As a result of a stronger dollar, at current rates we expect foreign exchange to be a headwind of approximately $70 million for the full-year 2016. Turning to adjusted EPS, we now expect full-year 2016 adjusted EPS to be in a range of $1.07 to $1.11, representing 15% to 19% adjusted earnings growth. Our previous guidance assumed the unfavorable FX on full-year adjusted EPS would be between $0.05 and $0.06. Given the fact that Q2 saw slightly less unfavorable impact than expected, we now believe the full year impact will be closer to $0.05, which assumes $0.02 to $0.03 in the second half of this year. On a GAAP basis we expect EPS to be in a range of $0.30 to $0.35. Now turning to Q3 2016, we expect consolidated revenues to be in a range of $2.35 billion to $2.85 billion. This represents year-over-year growth in a range of 7% to 9% organically and 8% to 10% operationally. We expect the foreign exchange headwind on Q3 revenue to be negligible. For the third quarter adjusted EPS is expected to be in a range of $0.25 to $0.27 per share, and GAAP EPS is expected to be in a range of $0.13 to $0.15 per share. Please check our Investor Relations website for Q2 2016 financial and operational highlights, which outlines Q2 results as well as Q3 and full-year 2016 guidance including P&L line item guidance. So with that, I'll turn it back over to Susie who will moderate the Q&A.

[Susan Vissers Lisa:]

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

[Operator:]

Thank you. Your first question comes from the line of Mike Weinstein from JPMorgan. Please go ahead.

[Michael Weinstein:]

Yes, good morning. First off, can you hear me okay?

[Daniel J. Brennan:]

Hey. Good morning, Mike.

[Michael F. Mahoney:]

Hear you fine, Mike. Thanks.

[Michael Weinstein:]

All right. Well, first off, fantastic quarter, obviously, so congratulations. Let me just clarify just on a few items. So number one, the pacemaker performance being as strong as it is on the back of the MRI launch, one question I've already gotten from people, is that a clean number? Is there any stocking in that number that we should be aware of? Second, the move in the Structural Heart guidance to the high end of the range, is that WATCHMAN more than Lotus? If you could kind of share any insights into that? And then I'll follow up. Thanks.

[Michael F. Mahoney:]

Sure. Good morning, Mike. On the pacemaker, our team has been waiting for a long time for that product approval. We've had some slow quarters in our pacemaker business in the U.S. Outside the U.S. has done quite well with that product for a while, so that's not a stocking number. We were ready for that launch for quite a while. And the team, our commercial teams did an excellent job executing it. So we think it's a very innovative product and long in coming. And the U.S. team essentially did what the OUS teams have done with that product for a while. And Structural Heart, we continue to be really excited about the future for Structural Heart. It continues to be our largest investment area as a company. We're comfortable with the high end of our guidance that we provided at $175 million to $200 million. We continued to invest long-term in R&D capabilities, clinical capabilities and commercial capabilities to prepare ourselves for the launch in the U.S. And we're really excited about the upcoming data that we expect to see in London Valves on our pacemaker rate with the addition of Lotus Edge and depth guard. So it's really an important category for us. As you know we continue to – we outlined at Investor Day back in I think 2013 and 2015 our focus to continue to grow in our core businesses and take share, which we're doing, and importantly expand into faster growth markets. And that's exactly what you're seeing as a company. And our Structural Heart investment really is kind of leading the pack there.

[Michael Weinstein:]

So Mike, I apologize, the question was within Structural Heart, WATCHMAN is what's driving to the high end of the range there?

[Michael F. Mahoney:]

What's driving the high end of the range there is we're just -continue to open up new accounts. We continue to improve our account utilization. And we continue to build up our commercial capabilities in the U.S.

[Michael Weinstein:]

Okay. The gross margin kind of issues in the quarter, I think that you did a good job of, Dan, walking through what those are. So if we look at the back half of the year and expect an improvement in the gross margin, that's because, one, your inventory issues from the AMS transaction basically you get to a better, safer cost on those products, and then the FX headwind that you saw this quarter on the gross margin should dissipate, is that accurate?

[Daniel J. Brennan:]

No, somewhat. Let me just make sure we're clear on that. So we're at 70.7% in the quarter. The guidance range for Q3 and the full year is 71.5% to 72.5%. So it implies the uptick that you mentioned in the second half. I think the two key drivers of that are the inventory charges for the CRM products related to the better uptake of MRI-safe brady and quad in the U.S. as well as the WATCHMAN FLEX. We don't believe that those repeat themselves. And then secondly, we will get the full benefit in the second half of the lower manufacturing costs that we have for 2016 standards because we'll now be selling all the inventory at the new standards, and we will have sold off all the inventory at last year's standards. Those are the two main drivers that put us back into the 71.5% to 72.5% range. FX, we actually assume, is probably somewhat in the same range as where it was in Q2. That's really the reason, if you think back to last quarter, our guidance for FX in gross margin would have implied about 70 to 75 basis points each quarter for Qs 2, 3, and 4. Now it's 120; so that's a 50 basis point difference. And that's the reason why the guidance for the full year came from 72% to 73% to 71.5% to 72.5%.

[Michael Weinstein:]

Got it. All right. I have a long list of questions, but I'll let some others jump in. Thank you.

[Daniel J. Brennan:]

Thanks, Mike.

[Operator:]

Your next question comes from the line of David Lewis from Morgan Stanley. Please go ahead.

[David R. Lewis:]

Good morning. In light of a very strong revenue quarter, guys, I hate to ask something as banal as cash flow, Dan, but you don't give us multi-year cash flow estimates that often and I noticed that your $6 billion free cash estimate in the next three years is 10% higher than what we were looking for. Can you just sort of walk us through kind of why that would be and some of the components? I imagine one component's CapEx and perhaps the other is margins. But our margins numbers are pretty high and you're still 10% above us. So what could be driving that significant upside?

[Daniel J. Brennan:]

I think you answered your own question there, David, a bit. It's margins and CapEx. So one of the things that we have this year is, as we detailed in our guidance at the beginning of the year, is a CapEx number at $350 million that's $100 million higher than we think we need to effectively run each year. So we get that back, hopefully, each of the next three years and then expanding margins. So our goal next year is 25%-plus. And as we've given guidance for or long-term goals for 27% to 28% by 2020, the combination of those two factors and the CapEx I think gets you a long way there. And then the other piece is that we're going to continue to try, from a working capital perspective, to make that be our friend. We have a lot of inventory initiatives in place to really hopefully lead the industry in that regard and be best-in-class. And when we do that, that'll turn something that's going to drag on cash flow into a positive and hopefully see the beginnings of that this year. You see that from us taking our guidance from 1.5 billion to 1.6 billion; a piece of that is the inventory initiatives.

[David R. Lewis:]

Okay. Very helpful. And then, Mike, maybe a couple of product questions. I guess the first is just sort of the forgotten biz for Boston MedSurg is sort of no longer forgotten given the organic growth. And specifically, Endoscopy has gone from mid-single growth last year to double-digit growth this year. I wonder if you could just give us a sense of sort of where we are in the product cycles. Is it share gain from competitors? Is it product cycles that is driving that? And then secondarily, on DES on SYNERGY, where do you think we are in sort of share versus mix? And obviously you're growing dramatically ahead of market. So what are some of the factors that are driving that? And I'll jump back in queue. Thanks. Great quarter.

[Michael F. Mahoney:]

Thanks, David. Yeah. We've definitely never forgotten about Endo. It's really an incredibly high-performing business and it has been for a number of years. And they really have just continued to grow and expand. So our Endo business enjoys a, first of all, a strong market; a bit fewer competitors in our Endoscopy markets than some of our others. It has very strong growth profile in terms of the market growth and OUS expansion. And we are a very strong category leader across the globe, and we continue to expand particularly in the emerging markets. The portfolio is really driving a lot of the launch, a lot of the success that you've seen in 2016, led by our SpyGlass digital DS platform, which is driving solid double-digit growth and helps pull through the core portfolio. We also launched a product called the AXIOS Stent which is doing very well, as well as a hemostasis clip. So the portfolio cadence for Endo is very strong. It's very well led. It's very globally oriented. And they also do a great job of laying out the economic value proposition for hospitals beyond the portfolio. So they continue to perform very well and intentionally somewhere in my comments with Mike in his first question, we're intentionally focusing on investing greater in faster growth markets and faster growth businesses. And they represent 40% of our operating income, the MedSurg sector does now for BSC, so more to come there. DES is doing excellent. And we had a few critics early on in our launch, saying we weren't being aggressive enough. We signaled all along that we're going to be – drive an appropriate premium price for this product because we believe it is the best product available in the marketplace and the data is proving that out. And maybe Keith can comment in a minute. So we believe it's the premium product. We do offer a premium price for it, and so we've been smart in our rollout of it. And I think physicians and customers have seen the value of the ease-of-use and the clinical data of SYNERGY. And we expect the U.S. penetration to be probably above 50%, closer to 50% to 60% in the U.S. in 2016, and we continue to roll it out globally. So the team's doing a nice job there. But again, it's part of the overall story in Interventional Cardiology. Again, pointing to faster growth segments, our DES doing well, a lot of investments in complex coronary and imaging, which are part of the portfolio, and clearly our Structural Heart. So Kevin Ballinger and the team are doing a nice job.

[Susan Vissers Lisa:]

Keith.

[Keith D. Dawkins:]

Yes, David. I think the SYNERGY stent operators around the world are appreciating the best-in-class acute performance because obviously if you can't deliver the stent, that's really the end of the discussion. And we have a lot of data now, including the EVOLVE II pivotal data, the EVOLVE (39

[David R. Lewis:]

Great. Thank you very much.

[Daniel J. Brennan:]

Thank you.

[Michael F. Mahoney:]

Thanks, David.

[Operator:]

Your next question comes from the line of Larry Biegelsen from Wells Fargo. Please go ahead.

[Larry Biegelsen:]

Good morning, guys. Thanks for taking the question and congrats on a really strong quarter. So, Dan, you raised the organic growth from 6% to 8% to 8% to 9%, but you only raise the EPS guidance by a penny. And so can you talk about why you're not getting better leverage on the incremental revenue? You kept the operating margin guidance the same. And then I had one follow-up.

[Daniel J. Brennan:]

Sure, Larry. I think probably the best way to explain that just to do a quick summary of the increase in revenue. So the revenue is $170 million higher at the midpoint of guidance and that breaks down into three things

[Larry Biegelsen:]

Got it – sorry.

[Daniel J. Brennan:]

And then we're also – just as you look at it still very pleased to be at 15% to 19% full-year EPS growth which would be four years straight of double-digit adjusted EPS growth.

[Larry Biegelsen:]

Got it. Sorry to interrupt there. And then for my follow-up, at the 2015 analyst meeting, the organic revenue goal was 3% to 6% in 2016 and 2017. You're now guiding to 8% to 9% in 2016. How should we think about the sustainability of the 8% to 9% and your goals in 2017 and beyond? And I recognize you're not giving guidance here, but you're way outperforming what you expected to do at your analyst meeting last year. Thanks for taking my questions.

[Michael F. Mahoney:]

Yes. Thank you. The team is outperforming as part of the high performance culture that we have as a company. We're very excited about the full-year guidance, 8% to 9%. As you said, it compares to 3% to 6% we laid out, so it's a pretty strong beat there, and strong momentum across really each region and each business. So, we're not going to provide any outlook into 2017. Clearly outperforming the market at this level is not likely sustainable each year. But that being said, we're constantly looking to outperform the market. We're investing in faster growth businesses, and we're very confident in our ability long-term to drive mid-single-digit revenue growth, improve margins and drive double-digit EPS growth.

[Larry Biegelsen:]

Thanks for taking my questions, guys.

[Daniel J. Brennan:]

Thanks, Larry.

[Operator:]

Your next question comes from the line of Bob Hopkins from Bank of America. Please go ahead.

[Robert Adam Hopkins:]

All right. Thanks. Can you hear me okay?

[Michael F. Mahoney:]

Yep. Hear you fine, Bob.

[Daniel J. Brennan:]

Good morning.

[Robert Adam Hopkins:]

Great. Good morning. So obviously, you've got the best revenue growth here for Boston Scientific essentially since the financial crisis, a higher absolute level of revenues than I think any of us thought, so congratulations on the unbelievable progress. I guess my first question is really kind of philosophical in terms of the long-term now that you've got this sort of higher level revenues and higher level of revenue growth. You guys have given some long-term guidance on operating margin targets and goals. So now that you're kind of outperforming on revenues, what's the thought on those operating margin targets? Is the thought that you'll take an opportunity to spend more and continue to sort of keep those operating margin targets? Or is it more likely that with this higher level of growth that you could be towards the high end or higher of the long-term targets that you've set previously?

[Daniel J. Brennan:]

Thanks, Bob. Yeah, I don't think we'll be changing the trajectory in terms of the margin guidance we've given. As we always say, it's about striking a balance between delivering durable, consistent revenue growth and expanding operating margins. And if you look at the numbers and see what we've done for the last three years relative to revenue growth and particularly on the margin expansion front, looking at 27% to 28% adjusted operating margin by 2020, and a consistent durable growing top line through that period and the goal of double-digit adjusted EPS growth each of those years, I think we're going to stick with that as our targets.

[Robert Adam Hopkins:]

No, I understand you're sticking with the targets, but I'm just trying to understand philosophically because you're outperforming so nicely here, is the bias more towards opportunities to invest more? Or let some of that through? Because again, these levels are just so much higher than we originally thought.

[Daniel J. Brennan:]

Again, it's striking a balance. We do have a lot of investment, as Mike mentioned, relative to Structural Heart. That's a lot of investment to get to the U.S. market and be successful there. And I think we're – it's always about striking that balance.

[Michael F. Mahoney:]

Yeah. And I think also we'll do an Investor Day 2017. We haven't nailed down yet. But we're making significant investments in platforms and markets that will have a big impact on the growth rate of the business in 2018, 2019 and 2020. And so you look at our launch in the U.S. of TAVR, our launch in the U.S. in the future of a deep brain stimulation, launching – only one that will have a drug-eluting stent and a drug-coated balloon for peripheral vascular, and we continue to expand into pulmonary and other areas across the company. So we definitely are investing for long-term growth, and a lot of it is big clinical investments in R&D that will impact the company, particularly in 2018, 2019 and 2020.

[Robert Adam Hopkins:]

Great. And then on Structural Heart just real quickly, what was the driver of you guys providing guidance? It'll be at the high end of the range, is that Lotus or WATCHMAN or both?

[Michael F. Mahoney:]

It's both. Both are doing quite well.

[Robert Adam Hopkins:]

Great. Thanks for taking the questions.

[Daniel J. Brennan:]

Thank you.

[Operator:]

Your next question comes from the line of Brooks West from Piper Jaffray. Please go ahead.

[Brooks E. West:]

Good morning. Can you hear me?

[Michael F. Mahoney:]

Yeah. I hear you fine, Brooks.

[Brooks E. West:]

Great. Thanks, guys. Just to put a cap on the gross margin discussion, so, Dan, those all seem like transient issues with the inventory. And I'm not trying to push for guidance for next year, but as I look at my model we've got you at about 73% gross margins for 2017. I don't see anything that I really need to flow-through into 2017 from this. Is that the correct way to think about it? I mean, you're a little bit lower for 2016, but in terms of thinking about the forward model that should resolve itself and we should kind of go back to where we thought we were going. Correct?

[Daniel J. Brennan:]

Yeah. I mean, I wouldn't talk specifically about a rate for 2017. Obviously, the goal is to continuously increase the gross margin rate. And it'll be part of what we believe is 25%-plus adjusted operating margin for next year, so with that as the goal. The FX in the back half is really the only thing that we believe is consistent from the Q2 performance. The other things I mentioned relative to inventory charges and the benefit from the standards, hopefully, to your point, is a transient thing. So the FX is the only one that continues into the second half.

[Brooks E. West:]

Okay. Perfect. And then maybe kind of piggybacking on Bob's question, but also thinking about some of the questions around MedSurg. You kind of conditioned us, in terms of the long-term operating margin progression, to think about Rhythm Management. And obviously, you're making great progress there. But given the growth we're seeing in MedSurg and Interventional Cardiology, it seems like that equation maybe needs to change a little bit. And if we allocate a little bit more of the strength in MedSurg to that equation, it seems like we push up to and through those targets maybe more quickly than if we were just relying on Rhythm Management. Is that also a fair kind of way to look at your business?

[Daniel J. Brennan:]

Yeah. I think the focus on Rhythm Management has really just been because of where they were, right. Starting off in the high single-digits, it's gotten a lot of focus over the last three or four years. I think we've made – Joe and the team have made tremendous progress getting it to the 16.9% that it is in Q2, the 18% to 19% that it'll be the second half of this year, and then ultimately the 20% next year and beyond that in 2018 and beyond. All the while, to you point, MedSurg and Cardiovascular have continued to grow their margins as well. So I think it goes back to what Mike said to the answer to the last question which is there's investments that we're making to ensure that durable growth 2018, 2019, 2020 and beyond and it's not just one business that has that investment. We're investing in all of the businesses. So we spend a lot of time looking at each of the individual segments and the profitability there, and the math adds up to what we've given for our goals.

[Brooks E. West:]

Perfect. And if I could sneak in just one product question, I'm wondering if Mirviss [Jeffrey] has decided whether to bring a drug-coated balloon to the U.S. or not?

[Michael F. Mahoney:]

Yes, we'll likely be providing additional insights on our clinical strategy with our balloon at the next quarterly call.

[Brooks E. West:]

Perfect. Thanks, guys.

[Operator:]

Your next question comes from the line of Rick Wise from Stifel. Please go ahead.

[Rick Wise:]

Good morning, everybody. Maybe let me start off with Lotus. Mike, you talked about gaining EU share in the quarter. Maybe give us a little more color on that, are you ready to quantify that at all? You've talked about penetration or share of greater than 30% in your selected accounts. And maybe just add some more color on the Edge launch coming up in September. Is this a share gainer? Or no, that's going to require more time and those additional sizes that are coming in the first half of 2017?

[Michael F. Mahoney:]

Yep. Sure. Again, the big investment for us in Structural Heart with WATCHMAN and TAVR, and you know, we're planning for the long-term here, particularly with our TAVR, given the market growth profile and how large the market is. And our view that we have a very differentiated platform from the other market contenders, given the controlled release of our Lotus valve and the lowest paravalvular leakage rates. So we think we truly have a differentiated platform in a very large market. We're a bit hamstrung in the near-term in Europe without having all five sizes. We have three of them today. So that hurts us a bit, but we'll solve that with a 21-millimeter in first quarter 2017 and eventually the largest size at probably first half 2017. So that will help. So in the meantime, we continue to do very well with the three valve sizes that we have. We won't provide any additional guidance in terms of number of accounts or penetration, but clearly it is a share taking strategy. The market's already large. The market's growing, and we're quite confident that we're currently the strong number three player. But that's not going to be our aspiration over the years, particularly as we launch Lotus Edge and depth guard.

[Rick Wise:]

Yeah. Turning to a bigger picture question, Dan obviously is emphasizing the growth in free cash flow this year, the $6 billion number you threw out over the next few years. You're also saying, Dan, that, I think correctly that with the settling or going a long way toward settling the IRS agreements a major uncertainty is off the table. I mean, all that suggests to me that that might give you more flexibility in thinking about M&A or portfolio additions. You just announced Cosman. How are you thinking about this, Mike and Dan? And should we be thinking that there is more possibility for M&A as a result? Any color would be appreciated. Thank you.

[Daniel J. Brennan:]

Sure, Rick. Yeah. I'll hit it from a financial perspective; maybe Mike can jump in on the strategic side. The goal – and I think you've framed it out very well, that's our goal is to eliminate the uncertainties that we have on the balance sheet. I think we've taken a lot of good steps in the quarter to do that. And that's going to give us more financial flexibility in the future. And that's the goal. So we should hopefully free up more of that cash flow for the long-term. We gave you the numbers hopefully as goals for the next three years. And the goal is to have as much of that available to fuel the business from an M&A and share repurchase perspective. So I don't know if anything specific, but yeah, I mean, that's really the goal is to eliminate the uncertainties and give us as much financial flexibility as we can have.

[Rick Wise:]

Thank you.

[Operator:]

Your next question comes from the line of Matt Taylor from Barclays. Please go ahead.

[Matthew Taylor:]

Hi. Thanks for taking the questions. So I guess the first question that wanted to clarify when you talked about MRI-safe timelines, could you just inform us what revising the goal for Tacky MRI timeline, entail what the change was there, and then S-ICDs still on track. Can you talk about how that's doing and how you expect MRI-safe approval to potentially improve sales for S-ICD?

[Michael F. Mahoney:]

Absolutely. We'll ask Dr. Stein to comment on this question.

[Kenneth Stein:]

Yeah, Matt. I mean on the MRI, not going to get into any of the details of the change in the protocol. But in the course of conduct of our ENABLE MRI trial, we have made a decision that we do need to revise the protocol with respect to patient screening and eligibility. And that's just the process of getting that protocol or vision through is what's going to cause the push in the timeline. Still have a goal of getting that approved by the end of 2017.

[Matthew Taylor:]

Great. And on S-ICD?

[Kenneth Stein:]

I'm sorry. Could you clarify the question on S-ICD?

[Matthew Taylor:]

Yeah. I was just curious. I may have missed the comment here because the comments went by kind of fast. But do you still have the same timeline for S-ICD MRI approval? And just how is S-ICD performing today?

[Kenneth Stein:]

Yeah. We still have the same timeline, anticipating approval Q3 of this year. And really couldn't be more pleased with what we've seen in terms of uptake of the EMBLEM MRI where it's been launched in Europe and the existing EMBLEM device in the U.S. and globally.

[Michael F. Mahoney:]

We expect EMBLEM MRI approval in the U.S. in third quarter.

[Kenneth Stein:]

Q3 this year.

[Michael F. Mahoney:]

Yep.

[Matthew Taylor:]

Great. And could you just talk about broader utilization? Obviously, your results were phenomenal this quarter. Are you seeing something going on in either the U.S. market or some of the emerging markets that you play in that's contributing to higher levels of utilization that may not continue going forward? Or do you think that you're really just outperforming your markets from good execution?

[Michael F. Mahoney:]

Well, thanks, Matt. It's Mike. I also don't want to be a broken record here, but I think I want to just reinforce, consistent with our Investor Day presentations in 2013 and 2015, we've continued to invest our portfolio into faster growth markets. So, kind of in the maybe 2011 timeframe, we called our market growth profile about 3% in the markets we compete in. So as we've shifted our portfolio over time into faster growth markets, we think the markets we compete in now are kind of in the 4% to 5% growth range, if you look at the composite of BSC. So we are pleased that we're outperforming the market, but we'll strive to continue to do so. But we think that we have fundamentally shifted the markets that we play in to about a 4% to 5% growth market versus maybe a 2% to 3% growth market 4 or 5 years ago. So the markets are stronger that we compete in and the team is doing a really nice job of outperforming.

[Matthew Taylor:]

Thanks for the thought.

[Susan Vissers Lisa:]

Greg, we'll take one more question please.

[Operator:]

Okay. That question comes from the line of Glenn Navarro from RBC Capital Markets. Please go ahead.

[Glenn John Novarro:]

Hi. Thanks for squeezing me in. Two questions. One, drug-eluting stents in the quarter up high-single digits, significantly outpacing the market. You have Abbott launching Absorb. So my question is, is this high-single digits sustainable, given Absorb coming into the market? Or should we anticipate a little moderation going forward? And then I had a quick follow-up.

[Michael F. Mahoney:]

So, yeah. We're not giving DES guidance for the third quarter or fourth quarter. We're going to continue to run the play, which is we believe we have the best product in the market, and Keith can comment a bit more on the clinical data. And we've been competing with Absorb in Europe for quite a while. We would put it at probably less than a 7% – the BVS probably less than 7% of the global market and it's been on the market for quite a while. So we feel like we're in the position of strength in terms of our product portfolio, and we continue to look at BVS, it's an interesting technology. And we've got a number of bets and it's a fact (57

[Glenn John Novarro:]

And then with Keith on the line, I'd love to get his thoughts on kind of SYNERGY versus Absorb. And then my follow-up result was on Eluvia which was just launched in Europe and the data is very strong. And once you come to the U.S. you'll be by far – you'll be the second DES on the market for peripherals but with by far the best data. So how is Eluvia doing in Europe? And it just seems like this is one product that has a significant opportunity that's flying under the radar screen so just thoughts on Eluvia as well. Thanks.

[Keith D. Dawkins:]

And so, Glenn, in terms of SYNERGY and BVS, obviously there's not a lot of head-to-head data between the two, but BVS has been available in Europe. It's had CE Mark for five-and-a-half years and the penetration, as Mike said, is mid-single digits. And you and everybody else on the call is well aware of the Absorb II and Absorb III data. The safety profile of drug-eluting stents is paramount. Safety profile is more important than efficacy. And with a stent thrombosis rate that is at least 2x SYNERGY, we feel that the first generation, fully absorbable scaffolds, the safety profile is open to question. We do have an interest in the space. Obviously, as a leader in DES we have to have that. And as you know also we have three shots on goal and our own internal FAST program which is a thinner strap, more deliverable stent, more compliant, less malapposition is in first human use trials now. And we are still anticipating commercialization in Europe in 2018.

[Glenn John Novarro:]

And then just your thoughts on Eluvia, how it's performing in Europe? And your thoughts on how it will perform in the United States once launched?

[Michael F. Mahoney:]

Sure. So we're early with our Eluvia platform. It's a large investment. We'll be announcing additional data sets on both our balloon and our stent at CIRSE, which I think is in Barcelona in September third quarter this year. So we'll continue to lay out our clinical data there. But I think just, again, the strength of having a – in Europe, a drug-coated balloon and a differentiated drug-eluting stents for the peripheral vascular offers physicians more options. And so it uniquely positions us in the SFA and it also helps us pull through our core portfolio. So I think these investments are paying off in Europe, based on the growth, and we've got to wrap up our clinical trial of Eluvia which we anticipate by year-end 2016. And so we look forward to that finishing. And then we'll provide additional comments on our balloon at our third quarter earnings call.

[Glenn John Novarro:]

Okay. Thank you for taking the questions.

[Michael F. Mahoney:]

Thank you.

[Daniel J. Brennan:]

Thanks, Glenn.

[Susan Vissers Lisa:]

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

[Operator:]

Thank you. Ladies and gentlemen, this conference will be available for replay after 10