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spk03: Good morning and welcome to the Boston Scientific third quarter 2020 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Susan Lisa, Vice President, Investor Relations. Please go ahead.
spk06: Thank you, Andrew. Good morning, everyone. 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 2020 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 financials and filings. The duration of this morning's call will be approximately an hour. Mike will focus his comments on Q3 performance inclusive of the impact of the COVID-19 pandemic. as well as future catalysts and the general outlook for our business. Dan will review the financials for the quarter, and then we'll take your questions. During today's Q&A session, Mike and Dan will be joined by 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 excludes the impact of foreign currency fluctuation and organic revenue further excludes the impact of certain acquisitions, including BTG, through August 15th, as there are no prior period-related net sales, as well as the divestitures of the global embolic microspheres portfolio and the intrauterine health franchise. On this call, all references to sales and revenue, unless otherwise specified, are organic. Finally, average daily sales, ABS, normalizes sales growth for a difference in selling days year over year. 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, the impact of the COVID-19 pandemic upon the company's operations and financial results, 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, and earnings, as well as our tax rates, R&D spend, and other expenses. Factors that may cause such differences include those described in the risk factor 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.
spk11: Thanks, Susie, and thank you to everyone for joining us today. And please report that we made significant progress in third quarter with excellent commercial execution and strong clinical adoption across our category-leading portfolio as we build new capabilities and fuel our new product launch cadence. We continue to invest in our promising future and are confident that this will enable us to continue to grow at the high end of our peer group, improve operating margins, and deliver double-digit adjusted EPS growth and strong free cash flow for the long term. In the third quarter, operational sales declined 2.5% and organic sales declined 5.7%, normalizing for currency and the divestiture of both our intrauterine health business and legacy bees business, as well as excluding the contribution of BTG through August 15th. Importantly, note that the organic revenue result includes a negative 230 basis point impact related to sales return reserves in the quarter, as we strategically shifted to a consignment-based model for our left atrial appendage closure franchise, with the launch of our next-generation Watchman Flex device in the U.S. I'll provide more detail on the strategy and the success of the Watchman Flex launch in a bit, as I now offer highlights of our performance in third quarter 20. Every region and every business segment improved sequentially versus second quarter, and many countries returned to year-over-year growth in third quarter. Regional performance improved significantly. It was very consistent around the globe. U.S. sales declined four, Europe, Middle East, Africa also declined three, and Asia-Pac declined four. We delivered growth in China for the second consecutive quarter, plus 2% growth in third quarter on an organic basis. This China growth includes a negative 770 basis point impact from sales return reserves. China has strong sales in complex PCI, including imaging, rhythm management, peripheral interventions, structural heart, and urology public health. And our swift progress diversifying the portfolio into these high-growth markets means that DES will represent approximately 10% of our China revenue in 2020. We expect our China business to accelerate growth in fourth quarter, and we are targeting double-digit growth in 2021, including the DES tender-related impact. This regional sales performance was mirrored with a balanced and sharp recovery across our business units. PI delivered 2% growth in the quarter. Europe Public Health, Neuromod, and Endoscopy revenue all declined 1 to minus 3. CRM was down 4 and EP was down 7. Interventional cardiology's organic 17% decline includes more than 10 percentage points of negative impact related to the combined sales return reserve for transition to watchman consignment and China DES tender, which are $63 million and $10 million respectively. Specialty pharma sales of $74 million in the quarter were in line with our expectations down mid-single digits year-to-date. Adjusted operating income of approximately $620 million represents a 23.4 adjusted operating margin, nearly double our second quarter rate, and down 270 basis points year over year. This, too, includes a negative 170 basis point impact related to the transition to consignment for a Watchman franchise. Adjusted EPS for third quarter was $37. Now to turn the outlook for fourth quarter. Trends continue to evolve largely as we've expected, with worldwide organic revenue improving sequentially in third quarter, even in those regions experiencing COVID flare-ups. We aim to return to organic revenue growth in fourth quarter, excluding the impact of the shift to consignment for Watchman, and with the obvious caveat of COVID uncertainty. From an adjusted operating margin standpoint, we're targeting a similar rate in fourth quarter, again excluding the impact of the shift to consignment for Watchman. Our businesses are strong with a compelling global pipeline and multiple ongoing launches with recent approvals that are helping lead our recovery. We're also benefiting from the overall high acuity mix of our business and site of care. Admittedly, determining the remaining backlog or estimating the new patient funnel remains a challenge and varies by business and region. We believe that we have worked through a meaningful portion of our patient backlog given the acuity profiles of our technologies. We're also encouraged by the ability of our customers to manage COVID while performing elective procedures, as well as improvement in new patient referral rates, which are still slightly below normal levels. We have confidence that across the portfolio, our broad product launch cadence will help offset these challenges. I'll now provide some additional commentary on the business units. Euro pelvic health sales declined 1% in the quarter, normalizing for the interuterine health divestiture. Sequential improvement was led by our stone and prostate health franchises with LithaView, Resume, and Spacor, all growing double digits in third quarter. Notably, Resume achieved its highest sales quarter ever, supported by our differentiated five-year clinical data. And we target ongoing improvement with new launches such as Spacor View in the U.S., as well as the benefit of a higher office ASC mix for our more elective procedures. For endoscopy, third quarter sales declined 3%, reflecting a favorable mix of both relatively high acuity and outpatient ASC site of service. Trends in the quarter were led in the U.S. by sequential growth in our hemostasis and biliary franchises, along with infection prevention, which grew double digits in the quarter. We continue to see good resilience in ERCP procedures for the pancreas and bile ducts, such as stone removal and tumor biopsies. Our Exalt D launch is accelerating with over 100 accounts open globally and encouraging early trends from the transitional pass-through payment granted by CMS that wouldn't affect July 1st in the outpatient setting. We also completed the limited market release of Spyglass Discover with surgeons enthusiastic about its direct visualization and resulting ability to treat patients effectively with a single-stage approach. thus enabling fewer interventions and shorter length of stay in the hospital. We continue to target launch of our single-use bronchoscope in the second half of 21. In CRM, third quarter sales declined 4%, with high-voltage sales down 3% and low-voltage sales down 7% for the quarter. We continue to believe that our 2020 CRM performance will be roughly in line with the overall market. And importantly, our LUX-DX implantable cardiac monitor is off to a strong start, given the seamless patient interface and back-end monitoring, plus the ability to be programmed remotely and have event detection settings adjusted without an in-person visit. EP sales were down 7% in third quarter, with trends showing strong sequential improvement. We've been very pleased with the limited market release of Polarex, which is a second-generation single-shot cryo catheter, and will move to full launch in Europe by year-end. EP's base remains one of the largest, fastest-growing markets in MedTech, announced expanded investment in the irreversible electroporation field with Parapulse. Of note, we have elected to discontinue further development and clinical investments of our Opama Luminize RF single-shaft balloon. In neuromodulation, organic revenue declined 3% as the business has returned very quickly to serve patients in need, aided by our broad portfolio, digital capabilities, and site of service. We've seen a nicely balanced procedural recovery across RF, VertiFlex, and SCS as we execute our category leadership strategy in pain. We're also pleased with our recent WaveRider Alpha launch in Europe, which offers the Contour Waveform, with up to 32 contacts, MRI capability, and Bluetooth connectivity. Turning to deep brain stimulation, our precise PC and JEVIA directional systems continue to drive market share gains. Additionally, the recent EU launch of our precise genus platform expands our capabilities in both the primary and rechargeable segments with full-body MRI capability and new Bluetooth capabilities. Genus builds on our innovative foundational technology designed to offer multiple independent channel control, directional capabilities, and integrated visualization of the patient's brain structure for optimal programming and outcomes. Turning to interventional cardiology, Q3 sales declined 17% organically, which includes more than 10 percentage points of negative impact related to sales return reserves for the transition to consignment for Watchman and the upcoming China DES National Tender. Within coronary therapies, new products like the Mamba microcatheter imaging products, such as Comet and Avigo, and the Synergy XD and 48mm transducer, TAVR sales grew both year-over-year and sequentially as we continue to focus on the EU launch of Accurate Neo2 and U.S. IDE enrollment, as well as continued U.S. and Japan rollout of Lotus Edge and U.S. intermediate risk trial enrollment. We're also pleased with the consistent progress of our cerebral embolic protection device, Sentinel, which grew over 20% in the third quarter. As disclosed at our TCT webcast earlier this month, we now expect U.S. approval for AccurateNeo 2 in 2024, as well as Lotus Edge indication expansion into intermediate risk in 2024. Our next-generation AccurateNeo 2 is launching in Europe and now offers low PVL rates, best-in-class pacemaker rates, and great hemodynamics. Lotus Edge offers predictable control with a platform that may be fully recaptured and repositioned at any time. We believe both vials offer distinct benefits, while Sentinel has uniquely demonstrated a reduction in stroke rates during TAVR procedures in both its IDE and numerous large registries. Returning to Watchman, the franchise experienced a very robust recovery in third quarter, with low double-digit growth, excluding the impact of the sales return reserve. Our U.S. limited market release of Watchman Flex has gone extremely well, with exceptional physician feedback, and we have moved into full launch ahead of schedule, and we're targeting a complete conversion to Flex by mid-2021. We believe the strategic shift to a consignment-based model strongly complements the launch of this highly clinically differentiated product, and we are purposely making this investment given the significant potential for Flex growth. Moving rapidly to a consignment model will enable us to better support customers and drive committed share agreements while accelerating the conversion to Watchman Flex at a price premium. our market leadership. We're exceeding our flex contracting goals thus far and targeting completing the vast majority of this shift to consignment by year end 2020, which will result in a slightly larger headwind to revenue growth in Q4 than Q3. Turning to PI, the third quarter organic sales grew 2%, reflecting an overall favorable mix of high acuity and outpatient site of care for procedures, as well as a category-leading portfolio and strong cadence of new product launches. Of note, the BTG interventional medicine portfolio grew high single digits on a pro forma basis in third quarter. All franchises in PI delivered growth in the quarter, arterial, venous, and IO, with particular strength in drug-eluting, IO, and China. We also continue to anticipate two imminent launches, Alluvia in China and Ranger DCB in the U.S., with Ranger Japan a large study with long-term follow-up and adjudicated outcomes presented TCT earlier this month, showed no association of mortality with pacotaxel-coated devices, and should further accelerate the growth of this important category where we are uniquely positioned. Venus results were solid, highlighted by a sharp recovery in our varithine and varicose vein therapy, and a new ECOS Interventional oncology continues to perform very well as TheraSphere Y90 share gains. We've also moved to full launch for the TruSelect microcatheter. BTG became organic mid-quarter, and as mentioned at TCT, we expect to exit 2020 realizing $125 million of the $175 million in originally target synergies ahead of plan and solely via cost As we continue to expand the BTG interventional medicine product lines globally, I'd also like to highlight several important sustainability accomplishments this quarter, including being named among the top 50 of America's most just companies by Forbes Just Capital for the second consecutive year. We rank 38 overall, second among all healthcare companies, and number one overall for diversity, equity, and inclusion. social justice, transparent customer communications, and ethical leadership were also commented. MIT Sloan Management Review Glassdoor also recognized BSC as a culture champion, one of only 21 companies named to this inaugural list. So as we continue our commitment to anti-racism, both actions and resources, including our important Close the Gap initiative to close the health equity gap in underserved communities through provider education and collaboration, advocacy and society partnerships, and patient disease state awareness. So overall, I'll leave you with a few key points about our bright outlook. We're encouraged by consistent quarterly improvement in business trends and resilience in the face of COVID flare-ups. We have a robust cadence of new product launches across the portfolio, such as Watchman Flex, Exalti, Polarex, Accurate Neo2, WaveRide Alpha, Precise Genus, and LuxDX. Our pipeline in 2021 and beyond also positions as well in high-growth markets with new adjacencies and a portfolio that offers us access, partnership, and expansion of our customer reach. We're strategically deploying investment spend to enhance our new launches and digital capabilities. And our strong financial position and compelling venture portfolio enables us to continue to develop multiple high-growth markets. As we close out 2020 and push to 2021, We remain highly confident in our long-term ability to grow at the high end of our peer group, improve operating margins, deliberate double-digit EPS growth, and strong free cash flow. I'm extraordinarily grateful to our employees for their winning spirit, and I'll now turn things over to Dan. Thanks, Mike.
spk12: Third quarter consolidated revenue of $2,659,000,000 represents a reported revenue decline of 1.8% and reflects a $19,000,000 tailwind from foreign exchange. On an operational basis, which excludes the impact of foreign currency fluctuations, revenue declined 2.5% in the quarter. BTG sales contributed 370 basis points prior to becoming organic on August 15th, partially offset by the divestitures of our legacy Embolic Beads portfolio and intrauterine health business. Excluding the net contribution of acquisitions and divestitures, organic revenue declined 5.7% and includes a $63 million or 230 basis point headwind from the sales return reserve related to our conversion to a consignment inventory model for our Watchman franchise. With the launch of our next generation Watchman Flex device here in the United States. volumes continued to trend upward through the ongoing COVID-19 pandemic. A rebounding top line and continued P&L discipline contributed to our Q3 adjusted earnings per share of 37 cents, along with a six cent tax benefit, which was partially offset by a negative four cent impact from the Watchman consignment sales return reserve. Adjusted in line with our expectations to approach 70% in the back half of the year, as we outlined on the Q2 call. The sequential improvement is driven by lower negative manufacturing variances, slightly offset by the impact of the transition to watchman consignment. As a reminder, Q2 production levels were below 75% of capacity, resulting in material manufacturing variances that were expensed within the P&L in that quarter. unfavorable manufacturing variances decreased and were capitalized within inventory on the balance sheet basis point headwind related to the Watchman consignment transition. This is slightly ahead of our expectations given the trajectory of our revenue recovery in the quarter and continued P&L discipline. We increased investment spending while maintaining prudent adjusted SG&A and adjusted R&D rates of 35.9% and 9.5% respectively. Q3 also had some favorability related to timing and investments to be similar to Q3, excluding the impact of Watchman consignment in both quarters. On a GAAP basis, operating margin was negative 7.7% and includes a $219 million intangible asset impairment, primarily related to APAMA, and a $260 million litigation-related expense. As Mike detailed, we've discontinued the development of the APAMA RF balloon, and I'll provide an update on our legal reserve shortly. Moving below the line, our expectations for full year adjusted interest and other expense have not changed from our Q2 call to be slightly above the range of $400 to $425 million provided at the beginning of the year. Our tax rate for the third quarter was 31.7% on a GAAP basis and minus 3.5% on an adjusted basis, which includes an $88 million non-cash benefit driven by this quarter's completion of the IRS examination of our 2014 to 2016 tax years in a favorable position compared to our reserves. This resulted in a $0.06 benefit to adjusted earnings per share. Adjusted free cash flow for the quarter was $870 million, and reported free cash flow was $595 million, driven by strong operating margins and improved working capital efficiency. As of September 30, 2020, we had cash on hand of $2 billion, total liquidity, including available credit facilities, of $4.8 billion, and a prudent debt maturity profile with no near-term maturities. During the quarter, we prepaid the remaining $250 million balance on our February 2021 term loan. This leaves us with no debt maturities until May of 2022. Capital expenditures for the third quarter were $49 million. We continue to expect full-year 2020 capital expenditures of approximately $350 million as we focus on certain plant expansions and projects to meet capacity With respect to our legal reserves, we booked $260 million in Q3, primarily related to MeSH, inclusive of a reserve related to one-time claims made by a coalition of state attorneys general. Year to date, we have made cash payments of $30 million into qualified settlement funds, leaving approximately $85 million remaining to fund outstanding billion 445 million fully diluted weighted average shares outstanding and expect approximately 1 billion 447 million for the fourth quarter 2020 and 1 billion 432 million for the full year 2020 in closing our businesses and pipeline remain very strong and our long-term fundamentals have not changed with targeted organic revenue growth at the high end of our peers sustained adjusted operating margin expansion, double-digit adjusted earnings per share growth, and strong free cash flow. Please check our investor relations website for Q3 2020 financial and operational highlights, which outlines more detailed Q3 results. And with that, I'll turn it back to Suzy, who will moderate the Q&A.
spk06: Thanks, Anne. Andrew, let's open it up to questions for the next 30 minutes or so. In order to enable us to take as many as possible, please limit yourself to one question and one related follow-up. Andrew, please go ahead.
spk03: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on the telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. Our first question comes from David Lewis of Morgan Stanley. Please go ahead.
spk10: Great. Well, good morning, and thanks for taking the question. Just got one for Mike and then a follow-up related for Dan. So, Mike, I just want to come back to this high-end device comment you made. So I just want to confirm that whatever the MedTech peers grow, let's say that's 4% to 5%, you inspire to grow three points faster. And then also for you, I think there's a concern in light of CRM and IC market dynamics or TAVR dynamics. that the ability to do that, frankly, has changed. So clearly people are focusing on the things that have gone below plan. Maybe you could let me focus on some of the pieces of the business or segments that are above plan that are giving you the confidence that that algorithm of three points above four to five or whatever have you have is still achievable. And then I'd follow up for Dan.
spk11: Good morning, David. Thanks for the question. Yeah, we're very confident in our ability to continue to grow at the high end of our peer group. We've done so for a number of years. are quite exciting. Now, if you look across our businesses in our launch schedule, You know, we've highlighted Watchman Flex, and we laid out at TCT why we believe the Watchman Flex market's larger than originally anticipated, and based on the increase in utilization that we're seeing, we see that as a multibillion-dollar market. So I don't want to go across every business, but we have a very strong product launch cadence. We talked about MPI with both the Luby stent and the pending approval for Ranger. We're seeing excellent growth out of our interventional oncology business led by BTG, which actually grew upper single digits in the quarter, and really the strength of our med-surg businesses. Our endo business with the launch of our single-use scopes, the momentum of our urology business, and we have two big launches in Neuromod. and Europe in both STS and DBS, where we continue to take share. So really across the portfolio, we have a rich bag of product launches. Clearly, we would have liked to have the accurate NEO approval prior to 2024, and that's certainly something that we wish we could pull in, and we'll continue to try that based on our discussions with the FDA. But if you look at just the incremental tailwind of Watchman Growth and Paxil, we believe those two elements there neutralize the slight delay with Acura Neo on its own. So we have a history of growing above market, and the product launch case we have is strong, and our VC portfolio is quite good, and the free cash flow and balance sheets that deploy against that is very strong.
spk10: Okay. Very helpful, Mike. And then, Dan, just for you, I appreciate the confirmation of growing in fourth quarter. Should we assume that growth in the fourth quarter is kind of low single-digit type growth? And then look, 21, I know we're not going to get a lot out of you here, but everyone's very focused on 21 as a percent of 2019. It's treated double-digit growth for next year. I wonder if maybe you'd comment on kind of the – reality of those numbers, but more specifically, any parameters you can offer us on 21 on the top bottom line tax margins for consideration of our models as we head into next year. Thanks so much.
spk12: guidance relative to a number, whether it be one number or another. So the commentary and our belief is that we're aiming to grow in the fourth quarter, obviously, with the COVID caveats that Mike mentioned. With respect to 2021, probably can't give you a lot of detail on that. We're right in the middle of our annual operating plan process right now. It except to say that, again, as I mentioned closing out my prepared commentary, that it's really the same goals we've always had, which is to grow at the high end of the peers, to expand operating margin, and to deliver double-digit adjusted earnings per share growth. So really no change there. We're working through the process. And the goal would be when we get to the February call to give you a sense of where we are and let you know what we think 2021 might hold.
spk03: The next question comes from Robert Hopkins of Bank of America. Please go ahead.
spk02: Oh, thanks, and good morning. Can you hear me okay?
spk12: Good morning, Bob. Yeah, you're fine, Bob.
spk02: Good morning. Great. Thanks so much. So to start, I apologize for the short-term-oriented question, but, Mike, I was wondering if you could just comment on the degree to which the pretty significant global flare-up of COVID in the last few weeks has impacted the business, and therefore how confident are you in that comment on fourth quarter that you offered ex-watchman?
spk11: Sure. So we obviously have seen an uptick globally. Everyone reads the newspapers there. I would say the hospitals are doing an amazing job of managing COVID while still performing elective procedures. So you've seen that with the sequential growth that we've had in third quarter. We're certainly mindful of the fourth quarter potential interruptions there. So our goal is to aim to return to grow ex-watchmen. But we're obviously watching COVID quite significantly like everyone else is. And we continue to see month-over-month improvement in our trends. But we put a caveat there in the fourth quarter as we aim to grow, excluding Watchman. And obviously, if the COVID dramatically improves or increases, and there's more shutdowns and more pressures on the hospital system, that that could impact the fourth quarter. But so far, we've seen nice improvement sequentially month-over-month. Hospital's doing a better job managing it. And patients need the care that products like Boston Scientific and our obviously managing our spend, and you saw the strong improvement in operating income margins in the third quarter and the drop through in EPS. So we expect that trend to continue.
spk02: Okay, great. And then just one product comment. Could you just remind me what you said on Watchman in the quarter? I think you said it grew double digits. Just curious. It sounds like you saw a very rapid recovery in Watchman over the course of the quarter. Just wondering if we could get any more specifics or details. And thank you.
spk11: It did grow double digits in third quarter, and it's really been just an excellent launch. The early results have been very good, and as I mentioned in the script, we aim with this consignment model to switch the high majority of our customers over by year end and complete that by second quarter. And that consignment model shift, we think, is a smart move because it gets flex in the hands of our operators, which they want. It allows us to tie up longer-term, highly committed share contracts
spk03: Great, thank you. The next question comes from Vijay Kumar of Evercore ISI.
spk13: Please go ahead. Hey, guys. Thanks for taking my question. Mike, maybe getting back to a bigger picture question on the algorithm here, double-digit earnings algorithm. One, perhaps could you give us an update on BTG? I think the last update was 506. depreciation, what synergy is coming in better where we are in BTG. And when you look at that 2021, I guess the double digits EPS is the right phase. 2019, I'm curious because, you know, the deals annualized here and it's included in the 2020 numbers and streets modeling close to 18, 19% revenue growth for next year. It seems a little excessive, but any comments I think would be helpful.
spk12: Sure, Vijay. This is Dan. I can start, and Mike can add in certainly as well. Relative to VTG, I think we're essentially even more committed to the benefits of that deal now than we were when we did it. You look at the growth, one of the highlights in the quarter, and Mike mentioned it, when you pro forma for the various pieces within interventional medicines, they were all at high single digits. That's in the middle of a global pandemic. So a lot of good hopes for that. Mike also mentioned on the BTG synergies that we had talked about $175 million in total synergies. Well, now we're at $125 million, we believe, exiting 2020. We believe that we'll get that whole $175 million in total out of cost. So the revenue synergies that we had planned will actually be upside. So we look at BTG as a nice... Relative to comps, I think the most relevant comp is going to end up being 2019. I mean, 2020, we will compare to that, obviously, but it's a different year. I'm not going to comment on the specific numbers that are out there relative to your revenue growth for 2021, but I think when you look at it, it'll be 2021 versus 2019. That'll be the most relevant comparison I think we have.
spk13: Gotcha. And then... Maybe on structural heart here, Mike, maybe just comment on scope, too. You know, does it matter? I mean, the stocks certainly have reacted post-ECP, but it feels like with that NEO2, it shouldn't matter. Perhaps could you talk about what structural heart should look like for Boston within Europe?
spk11: Sure. And Dr. Meredith can make some additional comments. But we just are launching scope, our NEO2 platform right now. And so that obviously, as you know, is our second-gen platform. It's shown in our EU studies that Dr. Meredith can further comment on. It's got improved PVL rates, very low pacemaker rates, very good hemodynamics, and it's our second-generation valve. And the enrollment in the U.S. is going quite well for that system. So we're quite bullish on accurate NEO2 in Europe. And we're hoping as COVID, as we're hopefully in the second half here of COVID overall, that we'll continue to accelerate the trialing in the U.S. for that platform. So we'll continue to reiterate that platform, and we're confident that the European team will deliver strong results in 21 with Acronia 2.
spk08: comments. I think you heard the panel discussion, Vijay, at TCT and most of the positions on the panel recognised that this was a comparison of a first generation versus a third generation They recognize that AccurateDO2 has a 60% larger skirt and significantly improved PBL performance in independent call adjudicated data sets. So I don't think it's going to influence the use of AccurateDO2.
spk13: Thanks, Guy.
spk03: The next question comes from Larry. Eagleson of Wells Fargo. Please go ahead.
spk09: Good morning, guys. Thanks for taking the question. Just a follow-up on TAVR. Actually, a couple TAVR questions, and I'll just leave it at that. Mike, at a high level, does it still make sense from an ROI perspective to develop two TAVR platforms? And then for you, Ian, I heard your comments to Vijay regarding the commercial impact. But, you know, given the results of Scope 1 and 2, you know, there seemed to be some clinical risk with the U.S. pivotal trial. And I've looked at the primary, you know, safety and efficacy endpoints. Can you talk about your confidence in the NEO2 U.S. pivotal trial, you know, being able to show non-inferiority, you know, between NEO2 and Sapien 3 and Evalute Pro, you know, given what we've seen with Scope 1 and 2? You know, it doesn't look like a slam dunk, but I'd love to hear your thoughts. Thanks for taking the questions, guys.
spk08: So perhaps I'll start with the second question there, Larry, about our confidence around the accurate analysis. CE mark study. And so we believe that data will certainly play out in the, what we saw in the CE mark study of AccurateNeo2 will play out in the US AccurateNeo2 IDE study. So we are working with the FDA now as a longer patient follow-up as part of that study, but we remain confident.
spk09: Thanks, Dr. Meredith.
spk11: Yeah, and the first question on our product portfolio, we're always looking at across our portfolio where investment spend makes the most sense given the market opportunities. And we've obviously had the two-valve strategy, and we're seeing strong results in the sites that are using Lotus in the U.S. Opening new sites has been a challenging exercise for us given the pandemic, but the sites that are using Lotus in the U.S. are using it quite regularly. So we do believe that the two-valve strategy makes sense, and we're excited about the AccurateNeo 2 launch in Europe.
spk03: Thank you, guys. The next question comes from Joanne Lynch of Citibank. Please go ahead.
spk05: Hi, can you hear me okay?
spk08: Yep, we hear you fine, Joanne.
spk05: Excellent. Good morning. Two sets of questions. First one has to do with some of your commentary for the fourth quarter. I'm curious why operating margins would not improve in the fourth quarter versus the third quarter. And I want to make sure I can quantify what the Watchman adjustment is in the fourth quarter, because you say you will have growth X Watchman adjustment.
spk12: Sure, I can probably take that one, Joanne. Second part first. We expect it to be roughly similar. So you saw a $63 million top line adjustment for the sales term reserve for the transition. And so as we look at it, obviously it depends on how that rolls out. And in terms of operating margin, the main driver of that is that Q3 was probably better than we had anticipated, so 23.4%. 170 basis point negative impact from the Watchman sales return reserve. So we're kind of back into a pretty good range on that operating margin in Q3 and would believe that as we head into Q4, being in that range for the fourth quarter is a good place to be. From a gross margin standpoint, it's probably, again, largely similar to what you saw in the third quarter. We were 69.3% gross margin. In the quarter, that included 60 basis point negative impact from the Watchman reserves. So we're in that 69 to 70 range. That's probably where gross margin would settle out in the fourth quarter. And the rest of the P&L should look pretty similar. So the adjusted operating margin for the fourth quarter.
spk05: Okay. And then big picture, there is a perception, and this is largely after the TCT meeting, that there's, how do I say this, sort of an execution issue that may or may not be happening at Boston Scientific. How much of this is reality and how much of it is just you have so many products that are going through the pipeline, not everything is going to go exactly as planned?
spk11: Last year, we put up about 7.3, and obviously with the impact of COVID in 2020, and we've seen strong improvements each quarter, and we're set up for a very strong 21 based on that product launch schedule. Now, there's no doubt that we were disappointed with the delay with Accurate Neo in the U.S. I think Dr. Merida just laid out some of those reasons, and now we're excited about the Neo 2 launch, but we are disappointed in the Scope 1 schedule. But I think the benefit of Boston Scientific is we're highly diversified. You look at the growth of Watchman, you look at the significant growth improvement across our businesses, and really the diversification of our business. We've, for many years in a row, continued to reduce down the weighting of DES and CRM in our portfolio, given the growth trajectory of those markets, and increased the weighting of our other businesses. look at the growth of our PI business with BTG, Endoscopy, Euro, Neuromod, and also the promising growth that we see in EP. So we clearly wish the accurate scope results would have been different. But if you look at the overall execution of the company and the diversification that we've enabled, as well as the strong free cash flow and ability to continue to improve margins, we're excited about 21 and beyond. Thank you.
spk03: Next question comes from Robbie Marcus of J.C. Morgan. Please go ahead.
spk00: Thanks for taking the question. Maybe Dan or Mike, I was wondering if you could speak to the current M&A environment. You know, you've had a lot of investments on the private side. The balance sheet looks better than it's been in the past. How should we think about M&A, and if you could also touch on the reason for the discontinuation of APAMA?
spk12: again, I can start and Mike can comment as well. The M&A environment is a little bit challenging. I think you're probably referring to the IPO market. So within our VC portfolio, we've seen some of the companies go public and with some pretty lofty valuations. You know, we weren't able to acquire those companies. Obviously, the upside on the other side of it is it's for the potential to acquire them. So it does seem to present a short-term challenge. We have over 40 companies in our VC portfolio, so there's a lot to choose from, and we'll see where that goes. And we have, as you know, we have the cash ready and available to be opportunistic relative to M&A in general. So still optimistic that we're going to get some good, solid M&A done over time and be able to add to the top-line story that we have.
spk11: The pipeline is certainly there of M&A opportunities, but we want to be disciplined in terms of the price that we'll pay and to drive shareholder value. So we'll continue to do that, and we certainly plan to do a few tuck-in acquisitions over the next 12 months. On APAMA, essentially we made a decision there on our portfolio. Given the timeline delays that were impacted, the APAMA program with COVID, Really along with faster than anticipated new technology developments, namely IRE, we made the decision to discontinue the development and clinical investment in the APAMA platform. So we're going to continue to invest significantly in our stable point, our force sensing catheter. We're very bullish on our APAMA, I'm sorry, on our cryo balloon in Europe. That will be in full launch mode in the fourth quarter, which should provide some significant growth in 2021. And we're very encouraged about the investment that we have in Ferropulse for IRE. And that's an investment we made six years ago. And now we have an option to purchase that company. So as the market continues to shift, we believe we're in a very strong position with those platforms for the future.
spk00: Thanks. And maybe a quick follow-up. As I listen to your commentary, it sounds like volume trends continue to improve. Are you able to speak to how the pipeline is filling up behind that, how patient visits and scans are filling up behind that, and is there a discrepancy by geography? Thanks.
spk11: Yeah, I had a few comments there in my script. It's a difficult one to call. I would say overall, globally, It differs by region, by state. Some states in the U.S. have very normalized referral patterns and new patient funnels. Some in the U.S. may be down 10%. China is essentially back to normal, I would say, and Japan is quite strong. So it really varies around the world. I think if you were to net it all out, it's down. So we're not quite at normal new patient referral programs globally. And we're down. It's tough to call that whether it's down 5% or down 10%, but it's down slightly. And it really varies by state and by country.
spk00: Appreciate it.
spk11: Thanks.
spk03: Yep. The next question comes from Rick Wise of Stiefel. Please go ahead.
spk15: Good morning, everybody. Maybe just a couple of product questions and just updates here. Mike, you highlighted the early success of Exalt D, 100 accounts open. Is that where you want it to be? Is that where you're expected? Again, COVID aside and, you know, post-COVID, is that where you're expected? Just maybe talk us through what's next. And I'll go ahead and ask the other two. I'm just curious, Sentinel obviously had a terrific quarter. What's next there? And talk about the trial enrollments. And maybe we haven't talked to the SICD program in a long time. Just wondering, it seems a little random, but just hearing some competitive noise. What's next from Boston Scientific on that side of the ledger? Thanks a lot.
spk11: Sure. So Exalt, Sentinel, and SICD. I'll get Dr. Meredith to pitch into the middle here so I don't bore you too much here. But on Exalt, we clearly lost, call it four to six months with Exalt without launch. But the really encouraging news in third quarter, we've really picked up quite a bit of momentum. So our accounts, we've had more access to our customers in the U.S. and in Europe. And we've opened approximately 100 global accounts. And so the team has really made strong progress, call it the last 60 to 90 days, and new account openings, training, and really starting to increase utilization of that platform. And we also had a nice tailwind. Just I would say broadly, we had strong tailwinds and reimbursement in third quarter. I won't get too off track, but with the new TPT with Exalt, that was a nice tailwind for that. So we looked at for Exalt to be a nice growth driver for us in 2021. We also have the surgical scope recently approved. we're on track for a bronchoscope. So that's a multi-billion dollar opportunity. You know, just broadly with reimbursement, I'll just call this out because we picked on a few of the headwinds with scope one and scope two. We had some great reimbursement news, not only with Alluvia, but with Exalt, also with ECOS in the quarter. So I think it really demonstrates, you know, the clinical efficacy of these platforms and additional reimbursement. So I'll turn over Sentinel to Dr. Meredith and maybe SICD comments from Dr. Stein. Thanks, Mike. Thanks for the question, Rick.
spk08: With respect to Sentinel, as you know, we're in more than 750 accounts worldwide and 20% of TAVRs in the sites that are actually using Sentinel are actually having a Sentinel procedure. Stroke, as you know, is a debilitating and devastating TAVR. We believe that this is the right strategy. The protected TAVR trial that you mentioned is now more than ever a critical study to actually prove beyond a shadow of a doubt that cerebral embolic protection is the right strategy for TAVR. We're very pleased with having designed that study process. trial and continue to activate sites despite COVID. Obviously, there was some slowing of new site activation in the second and early in the third quarter, but we believe that that will continue to ramp up. So we're looking forward to the results of that trial. It's a critical study in light of the trials as the single most important study in this field, and I'm glad that we actually planned this prospectively.
spk11: Dr. Stein, any comments on SICD?
spk14: Yeah, yeah. Thanks a lot, Mike. And Rick, I'll be quick here. I think we're very pleased with what we're seeing in terms of continued growth with the SICD. As I think you know, we recently reported out the results of two major clinical trials, Praetorian and Untouched. The operator published in the Women's Journal of Medicine on Touch was just published in Circulation, which really convincingly show that the SICD is a remarkably safe, straightforward procedure and ought to be considered as first-line therapy for the broad group of patients with a primary prevention indication who don't have indication for anti-bradycardia pacing or anti-tachycardia pacing. You know, I think what comes next and what's, I think, very exciting from that standpoint is we push out our modular cardiac rhythm management concept with the development of our Empower Leadless Pacemaker, which is designed to be able to communicate with the SICD and can deliver both backup brady pacing and anti-tachycardia pacing. And that is still on track to launch into clinical trials the first half of next year.
spk15: Thanks, everybody.
spk03: The next question comes from Matt. Please go ahead.
spk11: Good morning, Matt.
spk01: Hi. Can you hear me okay?
spk11: Yeah, you're fine.
spk01: Terrific. Thank you. So just a couple of questions, if I could, on ASCs and sort of your exposure to the outpatient channel. You've talked about that, if I remember correctly, kind of in the two-thirds range. If you could maybe comment on just how some of those businesses are performing related to the predominantly inpatient lines of business, maybe in terms of pre-COVID, you know, percent of pre-COVID levels or or any other metrics like that? And then I just had one quick follow-up on the same topic.
spk11: Sure. Yes, we provided, I think as our, maybe our first quarter is called, the mix by business roughly of our inpatient versus outpatient. And that's really kind of been very consistent in terms of the recovery during COVID. So across our businesses, we Not surprising where we had a stronger outpatient orientation. You've seen a bit stronger recovery there with PI and urology, endo and neuromod. You know, you saw neuromod, geez, it was down like, what, 70%, 80% or some crazy number in the second quarter and came back dramatically in the third quarter because of patient demand in that setting. So really, uro, endo, PI, neuromod are more oriented to outpatient setting and CRM. and interventional cardiology lean a little bit more towards inpatient. And the kind of patient recovery, if you look at the third quarter results, are pretty consistent with that.
spk01: That's super helpful. And then just if I could, I think we're all looking at the current trends and wondering over the next couple of months if we're going to be facing some version of what we saw in like July and August in some areas of the country. And, you know, in terms of hospitals getting, you know, capacity getting tighter, some regions, some states, you know, picking counties or zip codes and trying to steer folks away from booking inpatient cases or overnight cases or things like that. And I'm wondering if you have any comments or experience from how that went in those areas in Q3, because we did see a little bit of that and potentially what that might entail over the next several months if we continue to see that happen, as anecdotal as that might be.
spk11: Yeah, it's tough to call. I mean, we don't see a scenario where the results of 2Q are matched again. So we don't see that happening. And you saw, obviously, a strong improvement, 3% negative growth, neutralizing for the one-timers in third quarter. And as I mentioned before, we've seen sequential improvement really each quarter since the darkest time of COVID. And so hospitals are doing a remarkably good job of managing COVID patients and elective procedures. Hospitals have know, built additional capacity to manage COVID patients during the surge. They're better staffed for it. So I think it's going to be potentially a challenging winter, but the hospitals are much better prepared to manage it, I believe, than they were six, eight months ago. And they're also better able to manage elective procedures in parallel. So, you know, with that, we commented before that The new patient referral pattern globally still isn't at 100%. And so that likely still could be under some pressure as COVID continues to surge. But we'll continue to, we're having great progress in launching new products, getting products approved. We're managing our margins. We'll drive strong EPS. and we'll see how the COVID impact plays out. But we've seen sequential improvement monthly, and we continue to aim for growth in the fourth quarter despite the COVID challenges and excluding the watchman consignment.
spk01: Thanks, Mike. Appreciate that.
spk03: You bet.
spk06: Last question, Andrew.
spk03: Thank you, and that will come from Danielle Antelphi of SVB Lyrinc. Please go ahead.
spk04: Hey, good morning, everyone. Thank you so much for squeezing me in and congrats on a strong quarter. I have two products related questions. So first on Watchman, you know, one of the things investors are paying attention to is, you know, potential competitor coming to market. And I was hoping maybe you could outline what the most from a competitive perspective are that you've built around the Watchman business that should make us feel okay about the continued growth trajectory there. And I'll just ask my second now. On Exalt-B, given the financial constraints at hospitals, I'm just curious about how quickly that can be the meaningful revenue contributor that it probably ultimately will be. But, you know, hospitals have to work through their current financial duress. And those are my questions. Thanks so much.
spk11: Sure. Dr. Stein, do you want to speak to the Watchman clinical capabilities? Sure.
spk14: Yeah, thanks, Mike. And, Danielle, I think on Watchman, first of all, we're very pleased with the response that we've seen and the clinical data we generated with the Flex device approved on the basis of a trial that didn't just meet its endpoints but actually showed 100% successful seal at one year. And I think combined with the great clinical results, And physician familiarity and ease of use with the Flex device, I think, is very strong against any competition. We continue to push what is the most robust portfolio of clinical science on the safety and efficacy of the device. The ongoing option trial, which in spite of COVID has continued to enroll well, which extends the use of the device as a first line for patients following a fib ablation. And then, as I think you know, we've recently announced the imminent launch of our champion trial, which is a head-to-head trial of the Watchman device as first-line therapy against novel oral anticoagulants.
spk11: Yeah, so obviously the clinical safety efficacy is the primary driver, and that's why Dr. Stein commented first. And then on the business model, that was obviously one of the reasons we switched to the consignment model. was to continue to build a strong moat supported by our clinical efficacy and also the ease of use and just the penetration that we see globally. And the consignment model changeover allows us to drive longer-term, high-committed share contracts at the appropriate price uplift. So we think that's a smart move for us. On Exalti, I mentioned before with the – With the breakthrough status, we did get the additional reimbursement in the outpatient setting, which is very, very helpful. And we believe in the inpatient setting and the outpatient setting, there's room in that DRG that makes sense for the ExaltD platform. So our endoscopy team will continue to drive healthcare economic studies with ExaltD. It's clear that physicians see the benefit of reducing the risk of infection. And our team is gaining more and more capabilities in terms of how to drive utilization of Exalti as each month passes. So we think this will be a nice growth driver, and we know it will be a nice growth driver for us in 2021. Thank you. Thank you.
spk03: This concludes our question and answer session. I would like to turn the conference back over to Susan and Lisa for any closing remarks.
spk06: And thanks, everyone, for joining. We appreciate your time. And we'll now turn it back to Andrew for the replay details.
spk03: Thank you. This concludes today's conference call. Replay for this call may be accessed in one hour until November 4, 2020, by dialing 1-877-344-7529 or 1-412-3179. and use access code 10147673. Again, 10147673. You may now disconnect your line at this time. Thank you.
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