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spk14: Good morning and welcome to the Boston Scientific Third Quarter 2021 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 2. Please note this event is being recorded. I would now like to turn the conference over to Lauren Tangler, Vice President, Investor Relations. Please go ahead.
spk06: Thank you, Andrew. Welcome, everyone, and thanks for joining us. With me on today's call are Mike Mahoney, Chairman and Chief Executive Officer, and Dan Brennan, Executive Vice President and Chief Financial Officer. We issued a press release earlier this morning announcing our Q3 2021 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 one hour. Mike will focus his comments on Q3 performance as well as future catalysts and the outlook for our business, including Q4 full year 2021 guidance. Dan will review the financials for the quarter, provide more details regarding our Q4 and 2021 guidance, and then we'll take your questions. During today's Q&A session, Mike and Dan will be joined by our chief medical officers, Dr. Ian Meredith and Dr. Ken Stein. Before we begin, I'd like to remind everyone that on the call, operational revenue growth excludes the impact of foreign currency fluctuation, and organic revenue growth further excludes acquisitions and divestitures for which there are less than a full period of comparable net sales. Relevant acquisitions for organic growth versus 2020 and 2019 include Preventus, Ferripulse, and Luminous Surgical, which closed in March, August, and September of 2021, respectively, as well as VertiFlex and BTG Interventional Medicines, which closed in May and mid-August of 2019, respectively. Divestitures include BTG Spec Pharma, which closed on March 1, 2021, and the Global Embolic Microspheres Portfolio, an intrauterine health franchise, which were divested in August 2019 and second quarter of 2020, respectively. Guidance includes the recently announced Devorah Medical and Bayless Medical acquisitions, which are expected to close in Q4 21 and Q1 22 respectively. For more information, please refer to slide nine of our financial and operating highlights deck, which may be found on our investor relations website. On this call, all references to sales and revenue, unless otherwise specified or organic. Finally, growth goals of six to 8% ex-COVID represent comparisons between time periods in which results are not material impacted by the COVID-19 pandemic. A note, this call contains forward-looking statements within the meaning of the federal securities laws, which may be identified by words like anticipate, expect, may, believe, estimate, and other similar words. They include, among other things, the impact of COVID-19 pandemic upon the company's operations and financial results, statements about our growth and market share, new product approvals and launches, acquisitions, 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 comments.
spk09: Thanks, Lauren, and thank you, everyone, for joining us today. I'm proud of our global team's execution despite the various challenges presented by the COVID surge in third quarter. The third quarter was impacted by COVID more than we anticipated as the Delta variant surged globally and some elective procedures were deferred. While we aren't satisfied with this quarter's sales results, we delivered on our third quarter EPS and margin targets and we're confident that as global vaccination rates continue to increase and COVID wanes, we are well positioned to achieve our long-term sales goals. We continue to be excited and confident about the opportunities we laid out at our recent investor day. Further enabled by our strategy of category leadership, entry into higher adjacent growth markets, and tuck in M&A. Total company third quarter operational sales grew 10% versus 2020, while organic sales grew 11% versus 20 and 4% versus 2019. Just below our guidance of 12 to 14% versus 2020, as Delta impacted procedure volume globally. Despite the temporary impact of procedure volumes, we saw strength in new product launches, generated robust clinical evidence, and executed broadly across the portfolio. Q3 adjusted EPS of 41 cents grew 10.5% versus 2020 and 4% versus 2019, reaching the high end of our third quarter guidance range of 39 to 41 cents. Adjusted operating margin at 25.6% continues to improve, and was in line with our third quarter expectations. We continue to be pleased with our cash flow with third quarter pre-cash flow generation of $360 million and adjusted pre-cash flow of $525 million. We're updating our fourth quarter and our full year guidance ranges for both sales and EPS, which assumes some level of impact to procedures from COVID and staffing shortages. Compared to 2020, we target fourth quarter 21 organic revenue growth of 12% to 16% and full year growth of 18% to 19%. Compared to 2019, we target fourth quarter 21 organic revenue growth of 4% to 8% and for full year organic revenue growth of 5% to 6% versus 2019. Our fourth quarter adjusted EPS estimate is $0.43 to $0.45. And we're updating a full year adjusted EPS to a revised range of $160 to $1.62. Dan will provide more details on both sales and EPS performance and outlook, including the revenue contribution from our acquisitions this year. I'll now provide additional highlights in Q3 21 results, along with comments on our fourth quarter and 21 outlook. Within the regions on an operational basis, Q3 2020, the U.S. grew 15%, Europe, Middle East, Africa grew 8%, Asia PAC grew 8% and the emerging market sales grew 18%. Operationally, despite the impact from Delta, EMEA delivered solid growth in third quarter across the majority of businesses and countries, with notable strength in PI, EP, and Endo, fueled by new and ongoing product launches like TheraSphere, Polarex, and Axios. We continue to improve our NEO2 performance with strong utilization driving double-digit growth versus both 20 and 2019. Asia-Pac was impacted by pandemic-related lockdowns in parts of the region, though growth in China remained very strong. We're encouraged heading into fourth quarter in 2022 as countries within Asia-Pac are reopening as vaccination rates increase and COVID cases decline. Although Japan was in a state of emergency throughout third quarter, we were able to advance new product launches achieving number one share position with our Ranger drug-coated balloon, as well as launching Polarex in October. China continues to deliver excellent results, and sales grew 14% versus 2020. We continue to see momentum across their portfolio, driven by complex PCI and imaging, as well as new product launches like Alluvia and Axios. Digital tools are also playing a role, enabling virtual physician training and allowing us to expand our reach with differentiated products like Ivis. We continue to expect double-digit full-year 2021 growth from China versus both 2020 and 2019. I'll now provide some additional commentary on the business units. Urology and public health sales grew 7% organically versus 2020, and the luminous acquisition closed in September, which expands the urology portfolio and stone offering to include the Moses Laser, which is complementary to the LithoView single-use flexible ureteroscope in our broad portfolio of disposables that support kidney stone removal. The Prostate Health franchise grew double digits with continued strength in our Resume and Spacer businesses, and we're excited to initiate two trials in this space within the quarter. The Global Saber Clinical Trial, which will examine the effectiveness of SpacerView in reducing late toxicity in patients receiving a stereotactic body radiotherapy treatment for prostate cancer and a vapor trial, which compares resume to dual drug therapy for BPH. Our elective procedures within the pelvic health portfolio were impacted by the third quarter surge in Delta, but historical growth trends have shown a quicker recovery as COVID surges wane. In endoscopy, sales grew 11% organically versus 2020. Our market-leading global endoscopy portfolio continues to benefit from differentiated, innovative technology launches, including Axios, Resolution Ultra hemostasis clip, and single-use scopes. During the quarter, Exalt-B received FDA clearance and is now available in both U.S. and Europe, with physicians pleased with its image quality and suction capabilities. We continue to make progress with Exalt-D, and are launching the 1.5 enhanced EXALT-D design, which features improved physician ergonomics. Additionally, we're pleased to now have approximately 40% of ERCP procedures qualify for additional reimbursement with NTAP approval as of October 1st. In cardiac rhythm management, organic sales were flat versus 2020. SICD sales grew mid-single digits versus Q3 2019. supported by the launch of the enhanced electrode. While core CRM third quarter trends improved over first half 21, across both DFIP and PACER, we believe that growth likely lagged the market. Looking ahead, we anticipate stabilization in our core CRM growth exiting 2021 and into early 2022, supported by SICD and our differentiated HeartLogic offering. Within our diagnostics franchise, our LUX DX implantable cardiac monitor continues to gain share as physicians are pleased with the implant experience, technology, and remote programming capability. Our preventive business remains on track to deliver plus 20% growth for the full year versus 2020 on a pro forma basis, fueled by the broad and differentiated ambulatory ECG portfolio. Electrophysiology organic sales were up 10% versus 2020, driven by strong international sales in both Europe and Japan. International growth is well above market, driven by the innovative portfolio, including Polarex and StablePoint. Polarex was recently approved in Japan, with the first cases occurring in October. In addition, the frozen AF trial completed an enrollment, which represents an important step in bringing Polarex to the U.S. with an expected launch in 2023. We also closed our FairPulse acquisition in third quarter, which is the only commercially available PFA technology, and we are seeing strong early usage in a limited number of launched accounts in Europe. Finally, we announced our acquisition of Bayless Medical, further enabling our strategy of category leadership with a novel approach to left heart access. Within the U.S., the Bayless platform is used in close to 40% of EP ablation procedures on the left side of the heart. Furthermore, it is used in left atrial appendage closure and mitral valve intervention. We expect to close this acquisition in first quarter 2022. In neuromodulation, organic revenue grew 2% versus 2020, as underlying procedure volumes was impacted by the delta surge throughout much of the quarter. Within our pain management franchise, we continue to see excitement for our WaveRider Alpha SES system and differentiated FAST algorithm, as well as our Cognita digital solutions. Within deep brain stimulation, the majority of our accounts have transitioned to precise genus, and we continue to drive new account openings as physicians are pleased with the integrated platform and personalized therapy. And last week we received approval for our essential tremor indication, and they're excited to begin a limited launch in fourth quarter 2021, which will expand our addressable market by $2 billion. In interventional cardiology, organic sales grew 26% versus 2020, which includes a 1200 basis point tailwind related to the Watchman consignment sales return reserve taken in third quarter 20. Our Watchman franchise had another strong quarter of double digit growth as physicians continue to be pleased with the next generation flex performance and differentiated clinical data. This positive sentiment has been further supported by ongoing real world clinical evidence presented to HRS demonstrating high rates of effective LAA closure and low rates of complications post-procedure. We continue to innovate and are launching our fixed curve sheet offering greater deployment control and ability to reach an expanded range of anatomies. We also anticipate enabling our U.S. label to include DAPT to support physician and patient choice in patient implant care by year end. In TAVR, AccurateNeo2 continues to do well with physicians pleased with its clinical performance and ease of use backed by strong real-world clinical data resulting in approximately 20% market share in open accounts. Momentum continues with Sentinel, our cerebral embolic protection device, which is exceeding 20% share in the U.S. where it's utilized. Coronary therapies grew 8% versus 2020 as the China DES tender impact begins to annualize and our portfolio mix shift into higher growth markets continues to strengthen. We continue to see excellent growth in complex PCI and imaging, being driven by RotaPro and Ivis. We also just received FDA clearance for Avigo2, our next generation guidance platform. Purple Interventions consistently delivers with organic sales up 8% versus Q3 2020. TheraSphere was a standout once again and grew double digits in the quarter with continued momentum for the positive EPOC trial, a first of its kind where TheraSphere was studied as second line therapy with their primary endpoint of progression-free survival in patients with MCRC was met. Additionally, we've begun patient enrollment in the Mandarin trial, an important first step for bringing HCC treatment to China patients. In arterial, our drug alluvium portfolio continues to perform well, growing double digits for 2020 with positive late-breaking clinical data presented at VIVA earlier this month. Alluvia, our drug loony stun, exhibited superiority in the imminent trial, compared to bare metal stents, and two-year data from the Ranger 2 trial demonstrated continued high rates of primary patency and significant reduction in reinterventions with our Ranger DCB. In Venus, we continued to push forward with our first patient enrolled in a high P-throat trial. We also had late-breaking clinical data from the knockout PE registry presented at Viva, confirming the safety and efficacy of ECOS. Building our strategy of category leadership, we announced our acquisition of Devorah Medical and the Wolf thrombectomy platform, which is an innovative technology designed to rapidly capture and extract blood clots in arterial and venous systems while minimizing blood loss. We look forward to closing this acquisition in fourth quarter 21. More broadly, we're furthering our commitments to sustainability, and I'm proud to report that Boston Scientific is joining the United Nations Race to Zero campaign, And since 2017, we've reduced the BSC carbon footprint by 50% and are on track to meet our goal to be carbon neutral and all manufacturing and key distribution sites by 2030. We're building on this foundation to establish ambitious science-based targets to set us on a path to net zero emissions across our entire value chain. We are bullish about the future outlook of Boston Scientific. At our recent investor day, we detailed our LRP plans for growth of 68% growth, operating margin expansion to 50 basis points or more each year, and double-digit adjusted EPS growth. I'd like to extend a big thank you to our employees for their contributions and winning spirit. Sorry. And I'll now turn things over to Dan.
spk10: Thanks, Mike. Third quarter consolidated revenue of $2,932,000,000 represents 10.3% reported revenue growth versus the third quarter 2020 and reflects a $17 million tailwind from foreign exchange. On an operational basis, revenue growth was 9.7% in the quarter. Sales from the acquisitions of Preventus, Farapulse, and Luminis contributed 220 basis points, more than offset by the divestiture of specialty pharmaceuticals, resulting in 10.6% organic revenue growth, slightly below our guidance range of 12 to 14% growth versus 2020. Compared to the third quarter of 2019, organic growth was 4.1%, below our guidance range of 5% to 7%. This 4.1% growth excludes $35 million in 2019 sales of divested intrauterine health, embolic beads, and BTG specialty pharmaceutical businesses, as well as $117 million in 2021 sales of acquired businesses, which consists of half a quarter of BTG interventional medicines, a full quarter of Preventus, and post-closed revenue from FaroPulse and Luminous. Spend controls and a favorable tax rate drove Q3 adjusted earnings per share of 41 cents, representing 10.5% growth versus 2020, 4% growth versus 2019, and achieving the high end of our guidance range of 39 to 41 cents. Adjusted gross margin for the third quarter was 70.6%, in line with our expectations. We expect slight sequential improvements to continue in Q4 as some headwinds remain, in particular, the transient cost of running plants with COVID-specific measures, increased freight costs, and some price pressures on direct materials and wages. Third quarter adjusted operating margin was 25.6%, again, in line with our expectations, driven by spend controls and lower travel offsetting the revenue headwinds. We're pleased with our trajectory and continue to target adjusted operating margin to average 26% for the second half of this year. On a GAAP basis, operating margin was 13.2% and includes a $128 million intangible asset impairment, primarily related to Veneti as we've made the decision to retire the Vici Venus stent following our voluntary recall earlier this year. Moving to below the line, adjusted interest and other expense totaled $104 million, again in line with expectations. Our tax rate for the third quarter was 7.8% on an adjusted basis favorable to our expectations driven by the geographic mix of earnings. We ended Q3 with $1,436,000,000 fully diluted weighted average shares outstanding. Adjusted free cash flow for the quarter was $525,000,000 and free cash flow was $359,000,000 with $465,000,000 from operating activities less 106 million net capital expenditures. Our goal remains to deliver adjusted free cash flow in line with 2020, approximately $2 billion, as we continue to expect increased working capital investments in inventory and accounts receivable during the remainder of 2021. As of September 30, 2021, we had cash on hand of $1.9 billion. We continue to expect to close the acquisition of Devoro Medical in Q4 of this year and Bayless Medical Company in Q1 of 2022. Our top priority for capital remains tuck-in M&A, and we'll continue to assess additional opportunities in conjunction with our financial goals. I'll now walk through guidance for fourth quarter and full year 2021. For the full year, we expect 2021 operational revenue growth to be in a range of 18% to 19% versus 2020, which includes an approximate net 30 basis point headwind from the divestiture of our intrauterine health franchise and specialty pharmaceuticals partially offset by the acquisitions of Preventus, Farapulse, and Luminous. Excluding the impact of closed acquisitions and divestitures, we expect full-year organic revenue growth to be in a range of 18% to 19% versus 2020, and 5% to 6% versus 2019. For the organic comparison to 2019, full-year 2019 sales exclude $50 million in sales of our Embolic Beads portfolio and intrauterine health franchise, as well as $81 million in specialty pharmaceutical sales. And at the midpoint of guidance, 2021 sales exclude approximately $530 million in sales from recent acquisitions, including Verti- BTG Interventional Medicines through mid-August, Preventus, Farapulse, and Luminous, as well as $13 million of specialty pharmaceutical sales prior to divestiture. For the fourth quarter 2021, we expect operational revenue growth to be in a range of 14% to 18% versus 2020, which includes an approximate net 180 basis point tailwind from the acquisitions of Preventus, Ferropulse, and Luminous, partially offset by the divestiture of specialty pharmaceuticals. Excluding the impact of acquisitions and divestitures, we expect Q4 organic revenue growth to be in a range of 12% to 16% versus 2020, and 4% to 8% growth versus 2019. For the Q4 organic comparison to 2019, 2019 sales exclude $67 million in sales of our divested intrauterine health and specialty pharmaceuticals businesses. And at the midpoint of guidance, 2021 sales exclude approximately $90 million in sales from the acquisition of Preventus, Ferrapulse, and Luminous. We continue to expect adjusted below the line expenses which include interest payments, dilution from our VC portfolio, and costs associated with our hedging program to be approximately $400 to $425 million for the year. Based on year-to-date favorability, we now forecast our full-year 2021 operational tax rate to be approximately 10%, and our adjusted tax rate to be approximately 9%. We expect fully diluted weighted average share count of approximately 1,439,000,000 shares for Q4 2021 and 1,434,000,000 shares for the full year 2021. We are narrowing the range for full year 2021 adjusted earnings per share guidance to $1.60 to $1.62, which includes our update to sales guidance and considers Q3 performing at the high end of our guidance range. For the fourth quarter, adjusted earnings per share is expected to be in a range of 43 cents to 45 cents. Please check our investor relations website for Q3 2021 financial and operational highlights, which outlines more detailed Q3 results. With that, I'll turn it back to Lauren, who will moderate the Q&A.
spk06: Thanks, Dan. Andrew, let's open it up to questions for the next 35 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. Andrew, please go ahead.
spk14: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your 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 2. Again, please limit yourself to one question and one related follow-up. At this time, we will pause momentarily to assemble our roster. The first question comes from Bob Hopkins of Bank of America. Please go ahead.
spk11: Hi, thank you, and can you hear me okay?
spk10: Good morning, Bob. Very fine, Bob.
spk11: Thanks. Oh, great. Good morning. Thank you. So first question is pretty straightforward. I'm just curious how your thoughts on Q4 have evolved since the analyst day and what you're seeing today in terms of procedure volumes, you know, especially in the U.S.? ?
spk09: Sure. Good morning, Bob. Good morning. As you saw with some other peers, you know, third quarter, July was pretty good. And then we saw a slowdown, a larger slowdown than anticipated August and September. And I would say the last few weeks of September, you know, certainly improved versus that August, early September trend. And, you know, we provided our fourth quarter, you know, sales guidance here. You know, overall, clearly when you travel, you know, outside of the U.S., the vaccination rates are improving in the Western countries, Japan, South Korea, Australia. Vaccination rates are improving in Europe. And you know what the vaccination status is here. So overall, we are more optimistic about the improved growth in fourth quarter versus third quarter based on the improved vaccination rates. Although we do expect, you know, COVID still to be a bit spotty. We also highlighted some of the staffing challenges. So overall, based on the guidance, we do anticipate an improved fourth quarter versus third quarter, but we're still guarded given the staffing challenges to some locations and COVID.
spk11: Yeah, makes sense. And then just one quick follow-up on that. I guess taking a step back, one of the things that's giving a lot of MedTech investors pause right now is just the sheer number of macro issues to kind of think through from staffing, to COVID waves, to supply chain, to inflation. And that's before we even start to look at company fundamentals. So I guess one big picture question I'd ask you, Mike, is, you know, all that's making it kind of hard for investors to know how to think about modeling for, you know, the next 12 months. And so I just would love your kind of top down thoughts on the ability of Boston to deliver over the next 12 months, you know, given all these headwinds, you know, not asking for specific quantification of things, but just your ability to manage through all these headwinds.
spk09: Yeah, so if you think about that, you take a step back and look at third quarter, and that's why I started my script that I'm really proud of the team's global execution. Because if you think about it, we went through a delta surge in the third quarter, which was bigger than most anybody anticipated. And we grew 11% versus 20% and 4% versus 19%. Now, 4% is not a great number, but it's not a bad number, growing 4% given the delta surge. And during that time, we had nice improvement in operating income margin, despite some of the supply chain headwinds that everyone's familiar with. And we delivered our EPS growth. So in a quarter where Delta surged, we grew top line fairly well, clearly not where we want it to be in normal situations, but we improved margins. We hit EPS. And in the third quarter, we have all those macro issues you talked about, but we do anticipate moving forward that You know, the impact on COVID in the company when it surges has decreased upon each surge. So every time there's been a Delta surge, the performance, although not where we want it to be, has been better each time. And so that shows the hospital's ability to manage COVID. You know, one great thing about our portfolio was we're primarily an interventional medicine company. And I was at a couple sites just yesterday, and they're doing 80% of their Watchman volume outpatient now. So you've seen a dramatic shift in Watchman, for example, outpatient procedures. So I think our portfolio has tailwinds that support productivity for hospitals. Hospitals have shown the ability to execute despite surges. And in a quarter where about every macro issue was thrown on top of the company, I think the performance is quite good.
spk11: Great. Appreciate the thoughts. Thank you.
spk14: The next question comes from Robbie Marcus with J.P. Morgan. Please go ahead.
spk08: Yeah, great. Thanks for taking the questions. So maybe shifting over to some of the businesses, we'd love to get a sense of what you're seeing out in the field. I know it's early, but you have some competition coming from Watchmen. We'd love to hear what you're seeing there and just how you feel about your positioning and you know, how we should be thinking about trialing of competitive products in the near term.
spk09: Hey, Robbie. Good morning. You know, clearly the competition will have some trialing benefit, but I would say I've been in the field extensively in Europe last week as well as U.S. this week and probably never been more enthusiastic about the future of Watchmen. I made a comment earlier about the procedural trends, how efficient the procedure is being done with the Watchman Flex. You know, every doctor that we speak, that I've spoken with, which is quite a few in our field, doctors that have transitioned, which 99.9% of them have, from 2.5 to Watchman Flex, have increased utilization significantly. And they've done that because of the safety profile of the device. and the outcomes that they're getting. And then you see right now we have some additional product enhancements being launched with the delivery catheter, and we have a cadence of additional platforms being developed over the next two years as well as expanding clinical outcomes. So the growth in Watchman was excellent in the third quarter, and we think it will be a critical growth driver moving forward, and we have a lot of confidence in our ability maintain a clear leadership position here.
spk08: Great. And maybe just on the other side of the house, you yourself have several new disposable scopes launching. I know it was a tough environment over the past 12 plus months to get into hospitals and set up accounts, but maybe just the latest update on where you were in third quarter and where you think you'll be in fourth quarter with those launches and the environment and the receptivity so far. Thanks.
spk09: Yeah, I would say on Exalt D, it's commentary similar to previous calls where we continue to chip away at it, I would say. We're making progress primarily in the U.S. with capital placements. Utilization continues to improve. And importantly, we had an additional launch this quarter, the 1.5 Exalt D, which will address some ease of use enhancements in the in the platform, which doctors are anxious for. So I think that'll help. And it'll be a nice growth driver for Endo in 2022. I would say coming out of the quarter, we're more bullish on Exalt B, I would say. The performance of that platform is quite good in terms of its suction capability. And our team is ramping up supply chain manufacturing capabilities. to enhance supply for Exalt-B in 2022. So the combination will continue to, along with Axios and a lot of other products in Endo, continue to drive Endo to be nicely accretive to the company going forward here.
spk08: Great. Thanks for taking the questions.
spk14: The next question comes from Joanne Wench of Citi. Please go ahead.
spk04: Good morning, and thank you for taking the question. For the fourth quarter, there's a somewhat larger range than usual of 12% to 16%. I'm a little bit curious what takes you to the bottom end versus the top end. And I'd like to confirm that the buck succeeded $1.62 for the year. Assumes the higher end of the full year guidance?
spk10: Just that second question, the EPS range is $1.60 to $1.62. What's the question on that one, Joanne?
spk04: Does that assume the higher or the end of the guidance, the mid-range of the guidance? I thought I had heard higher.
spk10: I don't think it assumes that. It assumes that we're within the 4% to 8% range versus 2019 and the 12% to 16% range versus 2020 in the fourth quarter for sale.
spk04: Okay, thank you. Thank you for that clarity. And for the fourth quarter? What takes you to the top end versus the bottom end? Yeah.
spk10: As we saw in the third quarter, I mean, it's a little bit larger range than we're used to. But just as Mike detailed, the uncertainties around COVID and staff insurances and where we are, I think just provides for a larger range in the quarter. Again, four to eight, we think at any point in that range is good growth versus 2019 and 12 to 16 versus 2020. But just given the uncertainty, feel it's appropriate to have a little bit larger range for the fourth quarter.
spk04: Okay, thanks. And then a follow-up question on products. Can you just give us an idea of what you're seeing in Neuromod from a competitive landscape point of view? Thank you.
spk09: You know, it's a market where there's a lot of innovation, and there's a number of competitors. You know, I think we haven't had all the competitors report, but based on what we've seen so far, we think we gained share so far based on the competition that's reported today. based on really the platform that we recently launched with the FAST algorithm and that Cognita practice management software application that we also use as part of our system. So I think it's a dynamic market where there's a lot of new product enhancements, but I think our team in Valencia, our Neuromod businesses, we think best in breed in terms of innovation. Almost all of their innovations come internally, whether it be DBS or SCS, And they always have a pretty strong, impressive cadence of new launches every 18 months. So I put our team against anybody in SCS. And at least so far in the third quarter, we gained share. And this Faust algorithm is just in its early days of launching. Really, the business, as you know, Joanne, has been impacted by COVID. Our urology and neuromod businesses are the two businesses that are the most sensitive to surges and the most responsive when COVID wanes. And so, you know, hopefully, you know, the COVID trends will continue globally, and you'll see improvement in both urology and neuromod in fourth quarter as COVID continues to stabilize. So that's been a business that's been challenged during COVID, as have our competitors. But we expect that business to improve quite a bit as COVID improves.
spk04: Excellent. Thank you so much.
spk14: The next question comes from Rick Wise with Stifel. Please go ahead.
spk12: Good morning, Mike. Hi, Dan. I was hoping to get just at a big picture question. We're talking about the pressures of COVID. But on the other hand, I continue to read reports about patient backlogs. I read a report yesterday, a large hospital center in Maine has a backlog 1,500 procedures waiting to be addressed. How are you all seeing the backlog situation for your broad array of procedures? How are you dialing that in, not just to the fourth quarter, but how do we think about it impacting, how are you thinking about it impacting next year, that idea that there's growing backlogs everywhere in the world, probably?
spk09: Yeah, so, good morning, Rick. um so we're obviously we haven't we can't not going to give our guidance for 2022 yet uh we'll hold off a few more months but um you know our lrp goals are 68 organic uh you know we'll likely have a an organic comp of what five to six um going into it which is versus 19 and a bigger conference of 2020. but anyway so i mean overall you'd like to be optimistic because you think covet impact will be less in 22 than it is in 21 based on the vaccination rates and the improvement in Asia, Europe, and hopefully the U.S. as well. So you'd like to see in 2022 a better COVID environment. The staffing shortages are a bit of a challenge, but the hospitals do hustle and they figure out a ways to get things done. But it does create a bit of a headwind, but COVID should be better. And the backlog, you do see a backlog in some of our procedures. You see a Watchman backlog in other areas. So overall, I hope, I think the macro trend should point to better in 22 versus what we've seen in 21 given the vaccination rates broadly.
spk12: Gotcha. And just maybe one product question. You highlighted that on the DBS side, you're opening new accounts. And obviously, the essential tremor indication opens up a new opportunity. Can you give us a little more color on both those? Just, you know, where do you think you are in terms of opening new accounts? What do we expect? Is that going to accelerate? And how are you going to get after? Maybe you can give us a little more color on how are you going to get after that essential tremor indication?
spk09: Sure. It's a nice new indication for us. As you know, DBS is a nice growing market. It's still very underpenetrated. It's a market that does well when COVID wanes and a market that does not do well when COVID surges. So hopefully you'll see a improvement in fourth quarter across the board in the market, in particular with us, and a 22 as COVID improves. But it doesn't do well when COVID surges because of the duration of the procedure time and the fact that it It typically can be deferred a few months. Back to your backlog question. On the business itself, they've done an amazing job. We weren't a player at all six, seven years ago. And now we're the number one de novo market share leader in Europe. I would say we're probably likely tied for number one on de novo market share in the U.S. And the team continues to add sales and commercial resources. And the new indication obviously will help that business in 2022 now that we're on label. So it's a similar call point, a similar physician, the same commercial team that we have. So it's almost like a adjacency for us with the same physician and the same sales rep. So it should help the business in 2022. And again, I don't think I'm too optimistic, but I'm assuming COVID is broadly better at 22 versus 21. So that'll help the Neuromod DBS business.
spk12: Thanks, Mike.
spk14: The next question comes from Larry Beagleson with Wells Fargo. Please go ahead.
spk13: Good morning. Thanks for taking the question. One on Watchman, one for Dan on the P&L. So on Watchman, you know, I'd love to hear from Dr. Stein or Dr. Meredith kind of what the counter strategy and counter messages are For amulet, you know, if there's a doctor who is considering using it, you know, what data are you pointing to? You know, we have heard doctors are very satisfied with Flex, but I'm just curious, you know, kind of what you would say to a doctor who's considering, you know, using amulet, and I had one follow-up.
spk01: Well, perhaps I can start and then Ken can follow. First of all, as Mike alluded to earlier, one of the important features of Watchman Flex is the ease of use, the rounded ball design, the proven safety of the device. So, of course, physicians will trial new devices, but the support we have in terms of education and training, the ease of use of the device, The safety profile and the excellent outcomes we're seeing is really driving the continued use and loyalty to Watchman Flex. I think it's also important, Larry, as you know, to highlight that what we like about the AMULET-IDE trial is it's just another large trial that's provided evidence for left atrial appendage closure in the context of increased ischemic risk patients in the setting of atrial fibrillation. So that's going to grow the entire market. This is a big piece of evidence that basically says if you're at increased risk of stroke in the setting of atrial fibrillation, we've got two devices that were equally efficacious. Of course, it was very, very... focused on the first-generation device. Ken?
spk15: Yeah, no, thanks, Ian. Yeah, Larry, again, reiterate what Ian said. First off, right, the amyloid IDE shows everyone, again, more data that just as a therapy left atrial appendage occlusion is safe and effective and is a fantastic alternative for patients who need that kind of therapy. And then, you know, that trial looked against our last-generation device, a generation that's no longer sold in the U.S., and showed non-inferiority for safety and efficacy, but a higher rate of procedural complications, you know, if it were me, I know which device I'd wanna have.
spk13: That's very helpful. And Dan, you know, looking at 2022, you know, the streets at about 16% EPS growth, anything you'd call out that the street's missing, you know, and how should we think about the tax rate next year, you know, excluding a potential increase, you know, in corporate tax rates? Thanks for taking the question.
spk10: Sure. And I think as per usual, I think you're going to have to wait for our guidance until our Q4 call. So I wouldn't necessarily point to anything in 2022. You heard our long-term goals at Investor Day, but we'll hold off on guidance until we have our Q4 call in February.
spk12: Fair enough. Thanks.
spk14: The next question comes from Vijay Kumar with Evercore ISI. Please go ahead.
spk02: Hey, guys. Thanks for taking my question. I had two, one on Watchman and one on the tax rate, and I'll ask them both up front. Mike, on Watchman, we understand the market is underpenetrated and should expand massively given the amount of clinical data. But in the context of staffing challenges, you know, uh, code and my understanding is there are limited number of centers who can do these kinds of structural hard procedures. Um, you know, how should we think about market expansion versus, uh, uh, you know, is that going to accelerate in the, in this current environment, uh, given the challenges and you have a second player coming in, uh, would love your thoughts on, uh, on market expansion versus, uh, uh, competition and on, on tax, uh, Dan, Is the call for tax reform, what kind of impact should we assume? Thank you.
spk09: Hi, Vijay. Yeah, to be honest, we're extremely confident about Watchman going into fourth quarter and full year 22. I made a few comments before that, first of all, Watchman, the clinical results for Watchman Flex are extraordinarily good. And doctors have tremendous confidence in the platform, and they've been using it for about a year. And your average doctor is increasing their utilization of Watchmen every quarter because of the confidence that they have. And the referring physician community is seeing their patients recover and get off blood thinners and reduce the risk of stroke. So it's expanding the awareness in the referring physician community, the GI community, the neuro community. So there's a lot of momentum there. And the other important thing I mentioned, that productivity, even in COVID, You have hospitals dramatically moving watchmen, limiting anesthesia, using ice imaging, and doing procedures that are very, very efficient, in many cases less than an hour. And the economics of watchmen now are quite good across the U.S. So there's, you know, there's always headwinds and tailwinds across a diversified portfolio, but the tailwinds from reimbursement, procedural efficiency, Clinical outcomes, new clinical data, product cadence are very, very positive with Watchman.
spk10: And then on the tax rate, Vijay, as you'd expect, we're following the development of the legislation closely. I would say all of it is still a work in progress. As you see, there's a lot of negotiating of outcomes still going on. And as usual, we'll provide guidance on our Q4 call in February.
spk02: Thanks, guys.
spk14: The next question comes from Danielle Antofi of SVB The Rink. Please go ahead.
spk05: Hey, good morning, everyone. Thank you so much for taking the question. Mike, I appreciate all the commentary on COVID and improving, and I think we're all in the same boat. We hope it's better heading into next year. But just the new dynamic here is the hospital labor shortage, and I'm just curious sort of how you as a company are helping hospitals manage through that, what you're seeing hospitals do to adapt to be able to continue to get patients through the system and treated, given the labor shortages, which, you know, that to me seems like a tougher nut to crack as far as like sort of when that will resolve. It feels like that's not something that can sort of fix itself overnight. So we just love some commentary there.
spk09: Sure. I've been in the field a lot recently, and it is an issue for hospital CEOs. There's no doubt about it. They've had to increase their wages and labor force expenses to accommodate increasing wages for nurses and staff and so forth. So they're working through that process. But it's not going to be a short-term issue, but hospitals are pretty resilient. And as you know, a couple things I would say that point specific to BSE and how that's changing is just the use of telehealth and telemedicine and prescreening for patients has become, you know, very widespread and very efficient. So that reduces down significantly the number of patient visits to the hospital, drives more efficiency and staff productivity. So I think you're going to continue to see that trend, you know, continue to increase. Another one more specific to Boston is what I mentioned before is, you know, we're not a surgery company. So we're not driving multi-day length of stays in a hospital. The portfolio shift, the shift to interventional medicine is helpful for hospitals. And it gets patients in and out of the clinic or outpatient setting typically in the same day. And you see more of our complex procedures because of the capabilities and the technology we have augmented by imaging move to more outpatient settings. And I made the comment on Watchmen how that mix shift has moved more and more to same-day procedures. So I think a combination of telehealth, a combination of outpatient orientation and same-day procedures is very helpful for our product mix. And hospitals, just like anybody else, they innovate and they find a way. So it is a headwind. But it's, you know, in the quarter here where we had staffing shortages and its surge, we grew okay. And I think the surges will calm and the staffing shortage will likely linger a bit. But hospitals are pretty resilient in figuring out ways to drive volume.
spk05: That's it for me. That was very helpful. Thank you.
spk14: The next question comes from Matthew O'Brien with Piper Sandler. Please go ahead.
spk03: Good morning. Thanks for taking the questions. Um, Mike, as I look across the portfolio, I think a lot of things held up better than I might've expected going into Q3 with all these, these COVID headwinds, you know, with, with their sphere doing better and peripheral and, and, um, uh, preventive seeming to hold up, you know, CRM and Watchman obviously doing well, even when netting out the, um, the reserve tailwind. So what I'm curious about is what you're seeing in non COVID geographies, as far as the momentum in those businesses, You know, are you taking share with some of these new products? Are you seeing accelerating momentum with some of these new categories? And why wouldn't that accelerate coming out of COVID just given, you know, some of the underlying strength that I think is there?
spk09: Yeah, I think it should accelerate in a less COVID impacted year for sure. You know, you hit a number of the highlights. You know, our PI business has been very resilient consistently. Drives consistent high performance. We're the number one DCB player now in Japan. The team's done a great job with that launch. And the TheraSphere platform continues to do extremely well. And you saw that clinical data. So, you know, that division continues to do very well. Endo, I would put him despite COVID, grew 8% versus 19 in the quarter. And a number of new product launches. Euro has been impacted by COVID, but That typically bounces back when COVID improves. And we've got a lot of commentary and watchmen today. We saw strong EP growth in Europe. We continue to lag in the U.S., but the EP momentum we see in Europe and Japan is very encouraging based on our cryo capabilities as well as the early insights into FerriPulse. I don't know if I answered your question, but... I'm actually, as I said in the call, I'm really pleased with the quarter given the macro headwinds that the company faced.
spk03: Yeah, that's helpful. And as the follow-up on the acquisition side, you know, can you just talk a little bit about the plans for Devoro maybe over the next couple of years? And then Bayless, I think you said 40% of all your cases with interventional cardiologists of those cases are EP crossings. What can you do from an atrial appendage closure or mitral valve you know, perspective as we look at over the next couple of years.
spk15: Thanks. Maybe this is Ken. I'll start first with Bayless. So, yeah, you're right. We do see the Bayless technologies in the U.S. used in around 40% of EP ablation procedures on the left side of the heart, and at least that in structural heart left atrial procedures like Watchman or mitral valve interventions. It's one of the great things to us for that potential acquisition because of the synergies it provides across our entire portfolio of left atrial procedures. And, you know, just getting back to maybe some of the earlier questions, I mean, one of the advantages of it, right, is anything that makes our procedures safer, more predictable, and more efficient is just increasingly important in this pandemic and hopefully eventually a post-pandemic environment.
spk03: Yeah, and just real quick on Devorah. Thanks.
spk09: So Devorah hasn't closed yet. It'll close hopefully fourth quarter, I guess, pretty soon here. So we think it's a perfect fit for the PI portfolio. We have a lot of strength in our arterial business. with our Alluvia and DCB. Our interventional oncology business has been a very strong grower for many quarters in a row, and you saw the data coming out of our Therosphere business. And we're doing a lot of work in the venous area with ECOS, with clinical trial, but there are a few product segments where we have gaps, and Devoro does fill those. And so we made an early investment in Devoro a number of years ago because we like their technology, we like their leadership team, and sure enough, they've delivered quite well, and so we acquired them. But it's still an early stage product, it's still an early stage company, so we aim to have, Lauren, I'm not exactly sure what we've communicated in 22 in terms of product economy. Second half launch. Second half launch, okay. So you'll see second half 22 impact with product approvals and product launched. And we're excited about bringing that in.
spk03: Got it. Thank you.
spk14: The next question comes from Anthony Petroni with Jefferies. Please go ahead.
spk00: Thanks. I'll have a two-part question. One's high level and one's on Watchman. High level, I guess, can you recap, and the company did a good job in the midst of the pandemic, what percent of the overall portfolio is linked to non-urgent elective procedures versus critical. And so maybe another way of asking when we look into 22, you know, what percent of the business could potentially see a tailwind, what potentially can face a headwind. And then on Watchman, maybe just high level on how we see shares trending over time. Is this, you know, potentially a 70% Boston market, 30% Abbott? And that takes into consideration the different designs out of the gate. Just curious to hear comments on the differences in targeting different size anatomies and potentially the limitation from competition in having a complete left appendage closure immediately post-surgery. Is that limiting for any follow-up surgeries? Thanks.
spk10: Anthony, I can take the one on the relative level of acuity of the procedures. And the short answer is it varies by business, right? So if you look at cardiology and you look at peripheral, you look at cardiac rhythm management, those have held on and we're actually getting pretty good at this now at the number of waves we've had relative to COVID. Those are much more emergent and hold up better. Mike mentioned this earlier that businesses like neuromodulation and urology, they come down very quickly in a COVID wave. The good news is they come back very quickly. So it's kind of a V-shaped curve for those businesses. They obviously don't perform as well in a COVID setting, but they come back very nicely on the other side. So there's not really one number you can point to for the whole company and pinpoint it. It varies by business. But I think we've proven and have a good track record in a non-COVID environment that the business performs very well. And as Mike's comments preclude, that's what we're looking forward to in 22 and beyond.
spk15: And Anthony, on Watchmen, again, I think we just have to come back to You know, the amulet IDE trial compared that device to our last generation Watchman device. And the Watchman Flex device, which is now the device that we commercialize in the United States, is really set the standard for safety and for efficacy. And just to remind everyone, our Pinnacle Flex trial results with Watchman Flex show less than 1% procedural safety events no pericardial effusions in that trial through seven days, no device embolizations, and 100% effective left atrial appendage closure. And I just don't think there's anything else out there that approaches those numbers. So as Mike said, as Ian said, we remain highly bullish and highly confident in the continued success of WATCHMAN.
spk06: Thank you, Dr. Stein. With that, we'd like to conclude. Mr. Paul, thanks for joining us today. We appreciate your interest in Boston Scientific. Before you disconnect, Andrew will give you the pertinent details for the replay.
spk14: Thank you. Again, this concludes today's conference call. The replay for this call may be accessed in one hour until November 3rd, 2021 by dialing 1-877-344-7529 or 1-412-317-0088. and use access code 101-602-03. Again, 101-602-03. Thank you. You may disconnect your line.
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