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 two. Please note this event is being recorded. I would now like to turn the conference over to Lauren Tengler, Vice President, Investor Relations. Please go ahead.
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 Preventice, Farapulse, and Lumenis Surgical, which closed in March, August, and September of 2021 respectively, as well as Vertiflex and BTG Interventional Medicine, which closed in May and mid-August of 2019 respectively.
Divestitures include BTG S pec Pharma, which closed on March 1, 2021, and the global embolic microspheres portfolio and intrauterine health franchise, which were divested in August 2019 and second quarter of 2020 respectively. Guidance excludes the recently announced Devoro Medical and Baylis Medical acquisitions, which are expected to close in Q4 2021 and Q1 2022 respectively. For more information, please refer to slide 9 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, are organic. Finally, growth goals of 6%-8% ex-COVID represent comparisons between time periods in which results are not materially 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 Factors section of our most recent 10-K and subsequent 10-Qs filed with the SEC. These statements speak only as of today's date, and we disclaim any intention or obligation to update them. At this point, I'll turn it over to Mike for comments.
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 2020 and 4% versus 2019. Just below our guidance of 12%-14% versus 2020 as Delta impacted procedure volume globally. Despite the temporary impact to procedure volumes, we saw strength in new product launches, generated robust clinical evidence, and executed broadly across the portfolio. Q3 adjusted EPS of $0.41 grew 10.5% versus 2020 and 4% versus 2019, reaching the high end of our third quarter guidance range of $0.39-$0.41. 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 free cash flow generation of $360 million and adjusted free 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 2021 organic revenue growth of 12%-16% and full year growth of 18%-19%. Compared to 2019, we target fourth quarter 2021 organic revenue growth of 4%-8% and for full year organic revenue growth of 5%-6% versus 2019.
Our fourth quarter adjusted EPS estimate is $0.43-$0.45, and we're updating full year adjusted EPS to a revised range of $1.60-$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 2021 results, along with comments on our fourth quarter and 2021 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, POLARx, and AXIOS.
ACURATE neo2 performance with strong utilization, driving double-digit growth for both versus both 2020 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-19 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 POLARx 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 Eluvia and AXIOS.
Digital tools are also playing a role enabling virtual physician training and allowing us to expand our reach with differentiated products like IVUS. 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 Pelvic Health sales grew 7% organically versus 2020, and the Lumenis acquisition closed in September, which expands the urology portfolio and stone offering to include the MOSES laser, which is complementary to the LithoVue single-use flexible ureteroscope and our broad portfolio of disposables that support kidney stone removal. The prostate health franchise grew double digits with continued strength in our Rezūm and SpaceOAR businesses, and we're excited to initiate two trials in this space within the quarter.
The global SABRE clinical trial, which will examine the effectiveness of SpaceOAR Vue in reducing late toxicity in patients receiving stereotactic body radiotherapy treatment for prostate cancer, and a Vapor trial which compares Rezūm 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 Model 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 Model D and are launching the 1.5 enhanced EXALT Model 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 first. In cardiac rhythm management, organic sales were flat versus 2020. S-ICD 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 2021 across both defib 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 S-ICD 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 Preventice business remains on track to deliver +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 POLARx and Stablepoint. POLARx was recently approved in Japan, with the first cases occurring in October. In addition, the FROzEN-AF trial completed enrollment, which represents an important step in bringing POLARx to the U.S. with an expected launch in 2023.
We also closed our Farapulse 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 Baylis Medical Company, further enabling our strategy of category leadership with a novel approach to left heart access. Within the U.S., the Baylis 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 WaveWriter Alpha SCS System and differentiated FAST algorithm, as well as our Cognita digital solution. Within deep brain stimulation, the majority of our accounts have transitioned to Vercise Genus, and we continue to drive new account openings as physicians are pleased with the integrated platform and personalized therapy. Last week, we received approval for our essential tremor indication and are excited to begin our 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 1,200 basis point tailwind related to the WATCHMAN consignment sales return reserve taken in third quarter of 2020.
Our WATCHMAN franchise had another strong quarter of double-digit growth as physicians continue to be pleased with the next-generation FLX performance and differentiated clinical data. This positive sentiment has been further supported by ongoing real-world clinical evidence presented at 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 sheath, 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, ACURATE neo2 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 IVUS. We also just received FDA clearance for AVVIGO II, our next-generation guidance platform. Peripheral 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 EPOCH trial, a first of its kind where TheraSphere was studied as second-line therapy with a 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 to bringing HCC treatment to Chinese patients. In arterial, our drug-eluting portfolio continues to perform well, growing double digits versus 2020 with positive late-breaking clinical data presented at VIVA earlier this month. Eluvia, our drug-eluting stent, exhibited superiority in the EMINENT trial compared to bare metal stents, and two-year data from the RANGER II trial demonstrated continued high rates of primary patency and significant reduction in reinterventions with our Ranger DCB. In Venous, we continue to push forward with our first patient enrolled in the HI-PEITHO trial. We also had late-breaking clinical data from the KNOCOUT PE registry presented at VIVA, confirming the safety and efficacy of EKOS.
Building on our strategy of category leadership, we announced our acquisition of Devoro 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 of 2021. 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. Since 2017, we've reduced the BSC carbon footprint by 50% and are on track to meet our goal to be carbon neutral at 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 6%-8% 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. Now I'll turn things over to Dan.
Thanks, Mike. Third quarter consolidated revenue of $2.932 billion represents 10.3% reported revenue growth versus the third quarter of 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 Preventice, Farapulse, and Lumenis 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%-14% growth versus 2020. Compared to the third quarter of 2019, organic growth was 4.1% below our guidance range of 5%-7%.
This 4.1% growth excludes $35 million in 2019 sales of divested intrauterine health, embolic beads, and BTG Specialty Pharmaceuticals businesses, as well as $117 million in 2021 sales of acquired businesses, which consists of half a quarter of BTG Interventional Medicine, a full quarter of Preventice, and post-close revenue from Farapulse and Lumenis. Spend controls and a favorable tax rate drove Q3 adjusted earnings per share of $0.41, representing 10.5% growth versus 2020, 4% growth versus 2019, and achieving the high end of our guidance range of $0.39-$0.41. 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 Veniti as we've made the decision to retire the Vici Venous 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 million fully diluted weighted average shares outstanding. Adjusted free cash flow for the quarter was $525 million, and free cash flow was $359 million with $465 million 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 Baylis 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%-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 Preventice, Farapulse, and Lumenis.
Excluding the impact of closed acquisitions and divestitures, we expect full-year organic revenue growth to be in a range of 18%-19% versus 2020 and 5%-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. At the midpoint of guidance, 2021 sales exclude approximately $530 million in sales from recent acquisitions, including BTG Interventional Medicine through mid-August, Preventice, Farapulse, and Lumenis, as well as $13 million of specialty pharmaceutical sales prior to divestiture.
For the fourth quarter of 2021, we expect operational revenue growth to be in a range of 14%-18% versus 2020, which includes an approximate net 180 basis point tailwind from the acquisitions of Preventice, Farapulse, and Lumenis, partially offset by the divestiture of specialty pharmaceutical. Excluding the impact of acquisitions and divestitures, we expect Q4 organic revenue growth to be in a range of 12%-16% versus 2020 and 4%-8% growth versus 2019. For the Q4 organic comparison to 2019 sales exclude $67 million in sales of our divested intrauterine health and specialty pharmaceuticals businesses. At the midpoint of guidance, 2021 sales exclude approximately $90 million in sales from the acquisition of Preventice, Farapulse, and Lumenis.
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 million-$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 million shares for Q4 2021 and 1,434 million shares for the full year 2021. We are narrowing the range for full year 2021 adjusted earnings per share guidance to $1.60-$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 $0.43-$0.45. 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.
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.
Thank you. We will now begin the question- and- answer session. To ask a question, you may press star, then one 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 two. 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.
Hi. Thank you. Can you hear me okay?
Good morning, Bob. Very fine, Bob. Hi.
Oh, great. Good morning. Thank you. 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.
Sure. Good morning, Bob. I would-
Morning.
As you saw with some other peers, you know, third quarter, July was pretty good. Then we saw a slowdown, the largest slowdown anticipated August and September. I would say the last few weeks of September, you know, certainly improved versus that August, early September trend. 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, you know, Japan, South Korea, Australia. Vaccination rates are improving in Europe and, you know, with the vaccination status here. 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. Overall, you know, based on the guidance, we do anticipate an improved fourth quarter versus third quarter, but we're still, you know, guarded given the staffing challenges to some locations and COVID.
Yeah, makes sense. Then just one quick follow-up on that. I guess taking a step back, one of the things that's giving, you know, a lot of med tech 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. That's before we even start to look at company fundamentals. 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. 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.
If you think about that, you take a step back and look at third quarter. That's why I started my script on that I'm really proud of the team's global execution, because you think about it, we went through a you know a Delta surge in the third quarter, which was bigger than most anybody anticipated, and we grew 11% versus 2020 and 4% versus 2019. Now, 4% is not a great number, but it's not a bad number growing 4% given the Delta surge. During that time, we had nice improvement in operating income margin despite some of the supply chain you know headwinds that everyone's familiar with. We delivered our EPS growth. 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. In the third quarter, we have all those macro issues you talked about. We do anticipate moving forward that, you know, the impact on COVID and the company as when the surges has decreased upon each surge. Every time there's been a Delta surge, the performance, although not where we want it to be, has been better each time. That shows the hospital's ability to manage COVID. You know, one great thing about our portfolio was we're primarily interventional medicine company, and I was at a couple sites just yesterday, and they're doing 80% of their WATCHMAN volume outpatient now. You're seeing a dramatic shift in WATCHMAN, for example, it's outpatient procedure.
I think our portfolio has tailwinds that support productivity for hospitals. Hospitals have shown the ability to execute despite surges. In a quarter where about every macro issue was thrown on top of the company, I think the performance was quite good.
Great. Appreciate the thoughts. Thank you.
The next question comes from Robbie Marcus with JP Morgan. Please go ahead.
Yeah, great. Thanks for taking the questions. Maybe shifting over to some of the businesses, would 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 WATCHMAN. Would 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.
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 and as well as U.S. this week, and probably never been more enthusiastic about the future of WATCHMAN. I made a comment earlier about the procedural trends, how efficient the procedure is being done with WATCHMAN FLX. You know, every doctor 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 FLX have increased utilization significantly. They've done that because of the safety profile of the device and the outcomes they're getting.
You see right now we have some additional product enhancements being launched with the delivery catheter. We have a cadence of additional platforms being developed over the next two years as well as expanding clinical outcomes. The growth in WATCHMAN was excellent in the third quarter, and we think it'll be a critical growth driver moving forward, and we have a lot of confidence in our ability to maintain a clear leadership position here.
Great. 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+ 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.
Yeah, I would say on EXALT Model D, it's commentary similar to previous calls where we continue to chip away at it, I would say. You know, we're making progress primarily in the U.S. with capital placements. Utilization continues to improve. Importantly, we had additional launch this quarter, the 1.5 EXALT Model D, which will address some ease of use enhancements in the platform which doctors are anxious for. So I think that'll help. And it'll be a nice growth driver for Endoscopy in 2022. I would say coming out of the quarter, we're more bullish on EXALT Model B, I would say.
The performance of that platform was quite good in terms of its suction capability, and our team is ramping up supply chain manufacturing capabilities to enhance supply for EXALT Model B in 2022. The combination will continue to along with AXIOS and a lot of other products in Endoscopy continue to drive Endoscopy to be nicely accretive to the company going forward here.
Great. Thanks for taking the questions.
The next question comes from Joanne Wuensch of Citi. Please go ahead.
Good morning, and thank you for taking the question. For the fourth quarter, there's a somewhat larger range than usual of 12%-16%. I'm a little bit curious what takes you to the bottom end versus the top end. I'd like to confirm that the $1.60-$1.62 for the year assumes the higher end of the full year guidance.
Just that second question, the EPS range is $1.60-$1.62. What's the question on that one, Joanne?
Does that assume the higher end of the guidance, the mid-range of the guidance? I thought I had heard higher.
I don't think it assumes that. It assumes that we're within the 4%-8% range versus 2019 and the 12%-16% range versus 2020 in the fourth quarter for scale.
Okay. Thank you. Thank you for that clarity. For the fourth quarter? What takes you to the top end versus the bottom end?
As we saw in the third quarter, I mean, it's a little bit larger range than we're used to. Just as Mike detailed, the uncertainties around COVID and staffing shortages and where we are, I think provides for a larger range in the quarter. Again, 4%-8%, we think, at any point in that range is good growth versus 2019 and 12%-16% versus 2020. Just given the uncertainty, feel it's appropriate to have a little bit larger range for the fourth quarter.
Okay, thanks. A follow-up question on products. Can you just give us an idea of what you're seeing in Neuromodulation from a competitive landscape point of view? Thank you.
You know, it's a market where there's a lot of innovation and there's a number of competitors. 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, 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. I think it's a dynamic market where there's a lot of you know new product enhancements. I think our team in Valencia, our Neuromodulation business is 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 you know, pretty strong impressive cadence of new launches every 18 months. You know, I put our team against anybody in SCS, and at least so far in the third quarter, we gained share, and this FAST algorithm is just in its early days of launching. Really the business, as you know, Joanne, has been impacted by COVID. Our urology and Neuromodulation businesses are the two businesses that are the most sensitive to surges and the most responsive when COVID wanes. You know, hopefully, as you know, the COVID trends will continue globally and you'll see improvement in both urology and Neuromodulation in fourth quarter as COVID continues to stabilize.
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.
Excellent. Thank you so much.
You bet.
The next question comes from Rick Wise with Stifel. Please go ahead.
Hi. Good morning, Mike. Hi, Dan. I was hoping to get just 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 of 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 are you thinking about it impacting next year, that idea that there's growing backlogs everywhere in the world, probably?
Yeah. Good morning, Rick. We're obviously not gonna give our guidance for 2022 yet. We'll hold off a few more months. You know, our LRP goals are 68% organic. You know, we'll likely have an organic comp of what? 5%-6% g oing into it, which is, you know, versus 2019 and a bigger comp versus 2020. Anyway, I mean, overall you like to be optimistic because you think COVID impact will be less in 2022 than it is in 2021 based on the vaccination rates and the improvement in Asia, Europe and hopefully the U.S. as well. 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. It does create a bit of a headwind. With COVID should be better.
The backlog, you do see a backlog in some of our procedures. You see a WATCHMAN backlog in other areas. Overall, I think the macro trends should point to better in 2022 versus what we've seen in 2021, given the vaccination rates broadly.
Gotcha. 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 to you know, where do you think you are in terms of opening new accounts? What do we expect? Is that gonna accelerate? And how are you gonna get after? Maybe you can give us a little more color on how are you gonna get after that essential tremor indication.
Sure. It's a nice new indication for us. As you know, DBS is a nice growing market. It's still very under-penetrated. It's a market that does well when COVID wanes and a market that does not do well when COVID surges. Hopefully you'll see an improvement in fourth quarter, across the board in the market and particularly with us and in 2022 as COVID improves. It doesn't do well when COVID surges because of the duration of the procedure time, and the fact that it typically can be deferred a few months, back to your backlog question. On the business itself, they've done an amazing job. You know, 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. The team continues to add sales and commercial resources. The new indication obviously will help that business in 2022, now that we're on label. It's a similar call point, a similar physician, the same commercial team that we have. It's almost like a adjacency for us with the same physician and the same sales rep. It should help the business in 2022. Again, I don't think I'm too optimistic, but I'm assuming COVID is broadly better in 2022 versus 2021, so that'll help the Neuromodulation DBS business.
Thanks, Mike.
The next question comes from Larry Biegelsen with Wells Fargo. Please go ahead.
Good morning. Thanks for taking the question. One on WATCHMAN, one for Dan on the P&L. 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, you know, what data are you pointing to? You know, we have heard doctors are very satisfied with FLX, 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 have one follow up.
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 FLX is the ease of use, the rounded ball design, the proven safety of the device. 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 FLX.
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. That's going to grow the entire market. This is a big piece of evidence that basically says, if you're at an 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?
Yeah. No. Thanks, Ian. Yeah, Larry, again, reiterate what Ian said. First off, right? The Amulet 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. 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.
That's very helpful. Dan, you know, looking at 2022, you know, the Street's 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.
Sure. I think as per usual, I think you're gonna have to wait for our guidance until our Q4 call. I wouldn't necessarily point to anything in 2022. You heard our long-term goals at Investor Day, we'll hold off on guidance until we have our Q4 call in February.
Fair enough. Thanks.
The next question comes from Vijay Kumar with Evercore ISI. Please go ahead.
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 upfront. Mike, on WATCHMAN, you know, we understand the market is underpenetrated and should expand massively, given the amount of clinical data. You know, in the context of staffing challenges, you know, COVID and my understanding is there are limited number of centers who can do these kinds of structural heart procedures. You know, how should we think about market expansion versus, you know, is that gonna accelerate in this current environment, given the challenges and you have a second player coming in? Would love your thoughts on market expansion versus competition.
On tax, Dan, is the corporate tax reform what kind of impact should we assume? Thank you.
Hi, Vijay. Yeah, to be honest, we're extremely confident about WATCHMAN going into fourth quarter and full year 2022. I made a few comments before that. First of all, WATCHMAN, the clinical results for WATCHMAN FLX are extraordinarily good, and doctors have tremendous confidence in the platform, and they've been using it for about a year. Your average doctor is increasing their utilization of WATCHMAN every quarter because of the confidence that they have. The referring physician community is seeing, you know, their patients recover and get off blood thinners and reduce the risk of stroke. It's expanding the awareness in the referring physician community, the GI community, the neuro community. There's a lot of momentum there.
The other important thing, I mentioned that productivity, you know, even in COVID, you have hospitals dramatically moving WATCHMAN, limiting anesthesia, using ICE imaging and doing procedures that are very, very efficient, in many cases less than an hour. The economics of WATCHMAN now are quite good across the U.S. There's, you know, 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.
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. As usual, we'll provide guidance on our Q4 call in February.
Thanks, guys.
The next question comes from Danielle Antalffy of SVB Leerink. Please go ahead.
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. Just the new dynamic here is the hospital labor shortage. 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. Would just love some commentary there.
Sure. I've been in the field a lot recently, and you know, it is an issue for hospital CEOs. There's no doubt about it. You know, they've had to increase their wages and labor force expenses to accommodate increasing wages for nurses and staff and so forth. They're working through that process. You know, it's not gonna be a short-term issue, but hospitals are pretty resilient. As you know, a couple things I would say that point specific to BSC on how that's changing is just the use of telehealth and telemedicine and pre-screening for patients. It's become very widespread and very efficient. That reduces down significantly the number of patient visits to the hospital and drives more efficiency and staff productivity.
I think you're gonna continue to see that trend continue to increase. Another one more specific to Boston is what I mentioned before, we're not a surgery company, so we're not driving multi-day lengths of stay in a hospital. The portfolio shift to interventional medicine is helpful for hospitals, and it gets patients in and out of a clinic or outpatient setting typically in the same day. You see more of our complex procedures because of the capabilities and the technology we have, augmented by imaging, move to more outpatient settings. I made the comment on WATCHMAN, how that mix shift has moved more and more to same day procedures.
I think a combination of telehealth, outpatient orientation and same day procedures is very helpful for our product mix. Hospitals, just like anybody else, they innovate and they find a way. It is a headwind, but it's you know, in the quarter here where we had staffing shortages and a surge, we grew okay. I think the surges will calm and the staffing shortages will likely linger a bit, but hospitals are pretty resilient in figuring out ways to drive volume.
That's it for me. That was very helpful. Thank you.
The next question comes from Matthew O'Brien with Piper Sandler. Please go ahead.
Good morning. Thanks for taking the questions. Mike, as I look across the portfolio, I think a lot of things held up better than I might have expected going into Q3 with all these COVID headwinds, you know, with TheraSphere doing better in peripheral and Preventice seeming to hold up, you know, CRM and WATCHMAN obviously doing well even when netting out the reserve tailwind. 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? Why wouldn't that accelerate coming out of COVID, just given, you know, some of the underlying strength that I think is there?
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, drives consistent high performance. We're the number one DCB player now in Japan. The team's done a great job with that launch. The TheraSphere platform continues to do extremely well, and you saw that clinical data. You know, that division continues to do very well. Endoscopy, I would put them despite COVID, grew 8% versus 2019 in the quarter and a number of new product launches. Urology has been impacted by COVID, but that typically bounces back when COVID improves. A lot of commentary on WATCHMAN 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 Farapulse. I don't know if I answered your question, but actually, as I said in the call, I'm really pleased with the quarter given the macro headwinds that the company faced.
Yeah, that's helpful. 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? Then Baylis, I think you said 40% of all your cases with interventional cardiologists, or of those cases are EP crossings. What can you do from a atrial appendage closure or mitral valve, you know, perspective as we look out over the next couple of years? Thanks.
Hey, Matthew, maybe this is Ken. I'll start first with Baylis. So yeah, you're right. We do see the Baylis 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 of that potential acquisition because of the synergies it provides across our entire portfolio of left atrial procedures. 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.
Yeah. Just real quick on Devoro. Thanks.
Devoro hasn't closed yet. It'll close, hopefully fourth quarter, I guess, right? Pretty soon here. We think it's a perfect fit for the PI portfolio. We have a lot of strength in our arterial business with our Eluvia and DCB. Our interventional oncology business has been a, you know, very strong grower for many quarters in a row, and you saw the data coming out of our TheraSphere business. We're doing a lot of work in the venous area with EKOS, with clinical trial. There are a few product segments where we have gaps, and Devoro does fill those. We made an early investment in Devoro a number of years ago because we liked their technology. We liked their leadership team.
Sure enough, they've delivered quite well. We acquired them. It's still an early stage product. It's still an early stage company. We aim to have Lauren, I'm not exactly sure what we've communicated in 2022 in terms of product economy.
Second half launch.
Second half launch.
Yep.
You'll see second half 2022 impact with product approvals and product launched. We're excited about bringing that in.
Got it. Thank you.
The next question comes from Anthony Petrone with Jefferies. Please go ahead.
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? Maybe another way of asking, when we look into 2022, you know, what percent of the business could potentially see a tailwind, what potentially can face a headwind? 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 atrial appendage closure immediately post-surgery. Is that limiting for any follow-up surgeries? Thanks.
Sure, Anthony. I can take the one on the relative level of acuity of the procedures. The short answer is it varies by business, right? 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, 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 Neurology, they come down very quickly in a COVID wave. The good news is they come back very quickly. 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.
There's not really one number you can point to for the whole company and pinpoint it. It varies by business. I think we've proven and have a good track record in a non-COVID environment that the business performs very well. As Mike's comments preclude, that's what we're looking forward to in 2022 and beyond.
Anthony, on WATCHMAN, again, I think I just have to come back to the Amulet IDE trial compared that device to our last generation WATCHMAN device. The WATCHMAN FLX device, which is now the device that we commercialize in the United States, it is really set the standard for safety and for efficacy. Just to remind everyone, our PINNACLE FLX trial results with WATCHMAN FLX 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. I just don't think there's anything else out there that approaches those numbers. As Mike said, as Ian said, we remain highly bullish and highly confident in the continued success of WATCHMAN.
Thank you.
Thank you, Dr. Stein. With that, we'd like to conclude the call. 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.
Thank you. Again, this concludes today's conference call. The replay for this call may be accessed in one hour until November third, 2021, by dialing 1-877-344-7529 or 1-412-317-0088 and use access code 10160203. Again, 10160203. Thank you. You may disconnect your line.