Earnings Labs

Boston Scientific Corporation (BSX)

Q2 2015 Earnings Call· Thu, Jul 23, 2015

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by and welcome to the BSX Q2 2015 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 our host. Ms. Susan Lisa, please go ahead.

Susan Vissers Lisa - Vice President-Investor Relations

Management

Thank you, Katy. Good morning, everyone and thanks for joining us. With me on today's call are Mike Mahoney, President 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 2015 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 begin our prepared remarks with an update on our business progress and his perspectives on the quarter. Dan will then review our overall Q2 2015 financial results as well as guidance for full-year 2015 and Q3 of 2015. 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 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 Q3 and full-year 2015 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 those differences include those described in the Risk Factors section of our most recent 10-K and subsequent 10-Qs and 8-Ks filed with the SEC. These statements speak only as…

Susan Vissers Lisa - Vice President-Investor Relations

Management

Thanks, Dan. Katy, Let's open it up to questions for the next 25 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. Katy, please go ahead.

Operator

Operator

Thank you. And our first question comes from the line of Mike Weinstein at JPMorgan.

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan

Thank you. Good morning. Can you hear me okay? Michael F. Mahoney - President, Chief Executive Officer & Director: Hear you well. Good morning.

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan

Perfect. Thanks, guys. So, two items and I'll start maybe with Structural Heart. So, you had talked at the Analyst Meeting about LOTUS market share trending north of 10% in Europe. Could you just spend a minute on that? I think there was some back and forth at the meeting, just trying to get a sense where LOTUS is at this point. Is there anything more you can give us there? And then are there any metrics you can share on the WATCHMAN launch at this point in the U.S.? And how should we think about the dependence upon reimbursement either the NCD or the add-on payment in order to drive growth in 2016 and beyond? Thanks. Michael F. Mahoney - President, Chief Executive Officer & Director: Sure. Thanks for the question. Good morning. Overall, as we mentioned in the script there, we're very pleased with the performance of Structural Heart overall. We took the guidance up to the high end of the range of $75 million to $100 million, which includes as you indicated, WATCHMAN and LOTUS. And I do think having the combination of LOTUS and WATCHMAN does uniquely position us in a competitive Structural Heart field, particularly given the lead that we have in the U.S. with the WATCHMAN platform globally. So starting with WATCHMAN, your first question, the great news is we're on track and actually slightly ahead of schedule in terms of our year-end goal of driving 100 large account openings in the U.S. So, we're actually ahead of pace there, which is very encouraging. We indicated during the script we're very pleased with the clinical results that we're receiving and a lot of that's due to the very measured and we believe thorough training program that we've put in place. The implants to-date are…

Susan Vissers Lisa - Vice President-Investor Relations

Management

Keith, do you want to add anything? Keith D. Dawkins - Global Chief Medical Officer & Executive VP: Just to say, Mike, that on the clinical side the Berlin valve meeting in September we'll have the important data sets including the 250-patient REPRISE II extension one year data and the first 500 patients, that's half the patients of the RESPOND post-market study. And then more important (35:19) data coming out of (35:21) in October.

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan

Thanks, Keith. So, Mike, what's the appetite as well as the balance sheet bandwidth for additional M&A post the AMS acquisition? Michael F. Mahoney - President, Chief Executive Officer & Director: Well, we're always – as you know, we've always been, we think pretty smart with our acquisitions. So over the last few years with the Bayer acquisition, EP, Alliant (35:46), and now the AMS, that we've moved into faster markets. In terms of capacity, we saw, as Dan indicated in his script, we have capacity for tuck-in M&A, which is what we've historically done since I've been here. And so I think you'll see us continuing to be active in the tuck-in M&A area, so long as it hits our strategic fit and financial guidelines that we lay out.

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan

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

Operator

Operator

The next question comes from the line of Rick Wise with Stifel. Please go ahead. Rick A. Wise - Stifel, Nicolaus & Co., Inc.: Good morning, everybody. Turning to the U.S. CRM businesses, you both said I think you expected some additional headwinds from a product, competitive point of view. I'm just curious, was it better – it was a little worse than I expected, the pressure was a little greater, was it better or worse than you expected? And just as part of that, obviously, you're doing great in Europe with the mid-single-digit growth with the full sort of next wave portfolio. Is that the way we should think about the kind of growth we could see in the United States once you have that in 2016 and beyond? Michael F. Mahoney - President, Chief Executive Officer & Director: The answer to your question is yes. That's really why we articulated that. We grew over 5% in Europe with that new cadence of product. And it's been a consistent, I believe, five quarters in a row of performance like that despite the tough comps in Europe. So, we have a very strong portfolio, and that's the portfolio that we'll be launching essentially in 2016 in the U.S. and then later in Japan. So, overall, it's kind of – the U.S. has some pressure. We called it last quarter. We'll continue to see some softness there. So, we anticipate kind of maybe flattish growth in the second half overall CRM. But we really build a lot of momentum going into 2016 with that portfolio and the launch of EMBLEM in the U.S. in the back half as well. So, I think the other good news is for CRM overall, if you look at the trailing 12-months, we're up 2% to…

Operator

Operator

And our next question comes from the line of Bob Hopkins with Bank of America. Please go ahead.

Robert A. Hopkins - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please go ahead

Thanks and good morning. So just a couple of quick questions. I want to focus mine again on WATCHMAN. And first, Mike, I was just wondering if you could talk a little bit about the demand side of the equation. I realize fully that this is a controlled rollout, you need to be careful about training, but in the centers where you are rolled out, what are you seeing from the demand side, either for physicians and patients, anything that's kind of surprised you in the early going and again, particularly interested in terms of just demand for the product in the centers that you're launched. Michael F. Mahoney - President, Chief Executive Officer & Director: So we have Dr. Stein here. I thought maybe he'd provide some commentary on your question then I can add on to it. Kenneth Stein - Senior Vice President & Chief Medical Officer-Cardiac Rhythm Management: Yeah, Bob. I mean, we've been really gratified at the demand where we've launched it. I mean, really, we've been really carefully controlling the number of sites as we bring them on. As Mike mentioned in his script, we're actually bringing them on a bit faster than we had thought we would when we spoke at the Investors Day. But that really is what's throttling use of the device at this point. We have folks really asking us, joining all of our training programs. And it's early to say who are the patients who are getting it but what we've seen to-date, both in terms of patient selection and in terms of patient outcome is really right in line with what we expected to see based on our prior clinical trials.

Robert A. Hopkins - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please go ahead

And then the other thing I wanted to ask about as it relates to WATCHMAN is just a little bit more specific on the reimbursement side, relating to the add-on payment. I was wondering if you could set some expectations for us. How confident are you that you will get that add-on payment? And if you don't get it, does that change the way you think about the rollout of the product and the demand for the product in 2016? Michael F. Mahoney - President, Chief Executive Officer & Director: Well, I think we really won't to provide any additional comments on the – on our – kind of giving a percentage on that. We're very confident in the data of WATCHMAN as Dr. Stein has articulated. We're very pleased with the clinical outcomes that we're seeing in the launch. And so we think the submission has unprecedented clinical data for it, but we won't provide any further comments in terms of putting odds against it. And hopefully at the end of the 3Q earnings call, we'll have better visibility to it.

Robert A. Hopkins - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please go ahead

But I mean if you don't get it, does that matter to demand. So, we'll move away from how confident are you that you will get it, but if you don't, does that have a big impact, you think, on the rollout of the product? Michael F. Mahoney - President, Chief Executive Officer & Director: Well, I think, we're having a lot of success right now. So, we'll open 100 centers this year and so, there is a strong demand for it. It delivers an unmet patient need for patients who suffer from atrial fibrillation or at risk for stroke. Ken, if you have any additional thoughts on it? Kenneth Stein - Senior Vice President & Chief Medical Officer-Cardiac Rhythm Management: Just the only other thing that I just want to draw attention to is in addition to the NTAP, CMS has also proposed reassigning into a new higher class DRG...

Robert A. Hopkins - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please go ahead

Right. Kenneth Stein - Senior Vice President & Chief Medical Officer-Cardiac Rhythm Management: ...as opposed to the DRG 251, they proposed reassignment to 273, 274 which would represent a 20% increase – anticipate reimbursement to hospitals. And we'd expect running about that roughly in the same timeframe as the NTAP.

Robert A. Hopkins - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please go ahead

Great. Thanks very much.

Operator

Operator

Our next question comes from the line of David Lewis with Morgan Stanley. Please go ahead. David R. Lewis - Morgan Stanley & Co. LLC: Good morning. Just two quick questions. I guess first, Mike, I'm thinking about SYNERGY and that number you gave us of 30% mix ex-U.S. and that obviously suggests to a lot of us that conversion has been a lot tougher for SYNERGY and there's obviously been more sensitivity to price and value. So, I guess two questions off of that. I guess how would you expect U.S. mix to track relative to the ex-U.S. experience? And then, just given your comments on FAST, I guess the question I have is, is FAST worth it? I mean, can you actually demonstrate better outcomes with FAST than SYNERGY? Is that investment for shareholders a good investment in your view? Michael F. Mahoney - President, Chief Executive Officer & Director: Starting with SYNERGY, I think the big difference in the U.S. and Europe, really the difference in Europe as well as Japan as well, is high variance, much higher variance of pricing country-to-country. So, we have been very thoughtful about which countries we launch SYNERGY in and which countries we don't. And so, as you said, it represents 30% of our overall Europe DES revenue mix but it represents greater than 50% of our share in approximately the 10 EU countries that we're selling it into. So, where we sell it, we drive over 50% share and those accounts are paying a premium. And there's many countries that we don't sell it at all. In the U.S., there is less variance in the pricing across the hospital system. So, as a result of that, we do expect the share to be quite significant in terms of the mix…

Susan Vissers Lisa - Vice President-Investor Relations

Management

Just on SYNERGY and FAST, Keith, do you want to comment anything? Keith D. Dawkins - Global Chief Medical Officer & Executive VP: Sure. Yeah, David. Just a couple of things. So in relation to the mix of SYNERGY in Europe, of course, we don't have reimbursements in France yet, which we're anticipating in Q4 and France is the largest DES market in Europe, so that will make a significant difference. And then with regard to FAST, I think we all agree that the currently available commercial FRS product is not a workhorse product with sub mid-single digit (47:56) market share four years after CE Mark. So we think and we're confident that we can improve on the acute performance of FRS with our differentiated FAST technology. And that's the purpose of this first human use study to study the acute performance of our FAST products and we'll give more details of that at TCG (48:20) this year. David R. Lewis - Morgan Stanley & Co. LLC: Great. Thank you very much.

Operator

Operator

And your next question comes from the line of Josh Jennings with Cowen & Company. Please go ahead. Joshua T. Jennings - Cowen & Co. LLC: Hi. Good morning. Thanks a lot for taking the questions. I was just hoping for an update on the subcutaneous ICD platform, if there's anything new to report on the reimbursement front, any color on the European rollout. I know it's been still very early. And then any details on the launch plan in the U.S.? And then just lastly if you're continuing to see sequential sales growth for the subcutaneous ICD and whether there may have been any disruption this quarter in the U.S. with the EMBLEM planned launch in Q3? Michael F. Mahoney - President, Chief Executive Officer & Director: Sure. Thank you for the question. On reimbursement, the majority of the U.S. population's currently covered with the S-ICD. We estimate we're covering about 200 million lives today, including Medicare beneficiaries, about two-thirds of the Medicaid population and about 40% of the private pay market. And we continue to work on the private pay market, and we continue to make progress there. So, overall, in reimbursement, it's really not much of a headwind, and we continue to make good progress on the private side. EMBLEM really is off to a very strong start in Europe. We're not going to break out the EMBLEM sales in Europe, but we received very strong momentum off of that new launch. Physicians are very attracted to the 20% thinner design and longer battery life and also the ability to track patients remotely with the patient monitoring. In the U.S., you're really going to see a launch that'll take place more in the back half of Q3. And so, we're transitioning to that product in the U.S.,…

Operator

Operator

Our next question comes from the line of Brooks West with Piper Jaffray. Please go ahead. Brooks E. West - Piper Jaffray & Co (Broker): Hi, guys. Thanks for taking the questions. Mike, just following up on the last question, specifically on Lutonix. Can you guys give us a little bit better idea of the scale and opportunity for the U.S. drug-coated balloon partnership? And then just a little bit more detail on kind of how that product was received when you all launched it in Q2? Michael F. Mahoney - President, Chief Executive Officer & Director: Yeah. So, the alliance we have with Bard really works for both companies, given their investment in Lutonix balloon and our capabilities in atherectomy, thrombectomy and some of the complex PI procedures. So, the alliance is going well. It's very early. So, we're not going to break out separate sales or give kind of hospital account information given the competitiveness of that field. But I would say the early innings of it are very positive. The companies are working well together. They have excellent registry data that they've presented. And we have a very strong commercial team with a very wide portfolio to help them to leverage that. So, we're bullish about the alliance, but we're going to steer away from providing specific sales breakouts or account information. Brooks E. West - Piper Jaffray & Co (Broker): Do you see that though, Mike, as something that could be a $100 million product for Boston at some point? Michael F. Mahoney - President, Chief Executive Officer & Director: Yeah. You'd have to ask Tim Ring and the Bard team that. Brooks E. West - Piper Jaffray & Co (Broker): All right. And then one for Ken. Just on the growth trends in Electrophysiology. Can you – just a little bit more on what's driving that. Is that catheters? Is it the diagnostic piece you got from Bard? How is the rollout of the Rhythmia system going? Just any kind of detail on trends you could give us there would be very helpful. Thanks. Kenneth Stein - Senior Vice President & Chief Medical Officer-Cardiac Rhythm Management: Yeah. I'm not going to break it out specifically by product category, Brooks. Rhythmia, again, we are I would say well into the early phase of the launch and really very pleased with how the system's performing. It is really the first next-generation mapping system for arrhythmias – high density, high resolution. I can't tell you the number of cases that I've gone out and been with colleagues where you do the case and you finish and they say, gosh, we just never could've done this procedure successfully with any of the previous mapping systems. So, so far, everything that we've seen with it during the early launch has validated all of our thoughts when we purchased the technology. Brooks E. West - Piper Jaffray & Co (Broker): Okay.

Susan Vissers Lisa - Vice President-Investor Relations

Management

Katy, we'll take one more, please.

Operator

Operator

Okay. Our last question then comes from the line of Larry Biegelsen with Wells Fargo. Please go ahead.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Wells Fargo. Please go ahead

Hey, guys. Thanks for fitting me in. Two questions here. First, so, Dan, I couldn't help but mention you said early on that you've grown 6% or better the last six quarters per Mike's commentary. But the guidance assumes a bit of a deceleration. So, basically, are you saying that it's going to be difficult to grow 6% operationally in the second half of this year? And that $61 million this quarter for interest expense, is that what we should assume for Q4 in 2016 once the AMS deal closes? I did have one follow-up question on WATCHMAN. Thanks. Daniel J. Brennan - Chief Financial Officer & Executive Vice President: Sure, Larry. So, in terms of the second half revenue, I think there's really three key things that are the headwinds on the back half of this year. The first, and we mentioned this, is the IC comps. So, when you think of Interventional Cardiology last year in the second half, that grew 8% in Q3 and 10% in Q4, so 9% overall in the second half. So, we're up against much more significant comps on the IC side. We now are looking at CRM. We talk about that being flattish for the back half of 2015. Obviously feel good about the new launches we'll have in late 2015 and early 2016, and with Mike's comments, believe we're on the right side of a share gain strategy beyond that. But the next two quarters, should be flattish in CRM. So, those two – plus when you think of the operational revenue growth rate, in the first half of this year, we've had six months of Bayer revenue contribution, and in the second half, we'll only have two months without a comparable from the year prior. So, I think those are the real headwinds. We obviously have tailwinds as well. We're excited about the launch of WATCHMAN, and we're excited about, as Dr. Stein mentioned, Rhythmia, LOTUS in Europe, things like that. But the balance of it, we think 4% to 6% is the right range.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Wells Fargo. Please go ahead

But Dan, the $61 million per quarter, and then for interest expense, once AMS closes? Just lastly on WATCHMAN, I think this has kind of been asked a few different ways on the call, but how common are the local non-coverage decisions in place for – that have been put in place for Lariat and how much do you think that's impacting the early uptake? And that's it for me, guys. Thanks for taking the questions. Daniel J. Brennan - Chief Financial Officer & Executive Vice President: Sure. I'll take the interest one quickly and then turn it over for the second one. I'd say the net of the new debt at the favorable rates offset by the fact that we have incremental debt for the AMS acquisition probably puts us in a $10 million to $20 million a year increase in overall interest expense, on an annual basis. Michael F. Mahoney - President, Chief Executive Officer & Director: And, Larry, just on WATCHMAN, not a whole lot new there. Just to reinforce, the vast clinical data that we have with WATCHMAN. I would argue is quite a bit different than what we've seen with Lariat in the U.S. So, it's difficult to even put those platforms in the same bucket. And so, the good news is we've enrolled our first 50 centers faster than planned and we'll likely enroll our second set of 50 centers, the goal of 100 centers faster than plan and we're delivering very good outcomes. And we're receiving strong uptake from it and we'll get more on the reimbursement pathway as we mentioned with the NCD in November and the NTAP as well. So, we like the momentum that we have and as Dr. Stein said, we'll continue to layer on more and more clinical evidence on top of WATCHMAN to further differentiate it.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Wells Fargo. Please go ahead

Thanks for that.

Susan Vissers Lisa - Vice President-Investor Relations

Management

Okay. Thanks, Mike. And with that, we'd like to conclude the call. Thanks for joining us today. We appreciate your interest in Boston Scientific. Before you disconnect, Katy will give you all the pertinent details for the replay. Thank you.