Boston Scientific Corporation

Good morning and welcome to the Boston Scientific Fourth Quarter 2020 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Susan Lisa, Vice President, Investor Relations. Please go ahead.

Thank you, Andrew. Good morning, everyone, and thanks for joining us. With me on today's call are Mike Mahoney, Chairman and Chief Executive Officer, and Dan Brennan, Executive Vice President and Chief Financial Officer. We issued a press release earlier this morning announcing our Q4 2020 results, which included reconciliations of the non-GAAP measures used in the release. We have posted a copy of that release, as well as reconciliations of the non-GAAP measures used in today's call, to the Investor Relations section of our website under the heading Financials and Filings. Duration of this morning's call will be approximately one hour. Michael focuses comments on Q4 performance, inclusive of the impact of the COVID-19 pandemic, as well as future catalysts and the outlook for our business, including Q1 and fiscal year 2021 guidance. Dan will review the financials for the quarter, provide more details regarding our Q1 and fiscal 21 guidance, and then we'll take your questions. During today's Q&A session, Mike and Dan was 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 excludes the impact of foreign currency fluctuations, and organic revenue further excludes the impact of certain acquisitions, including VertiFlex through June and BTG through August 15th, as there are no prior period-related net sales, as well as the divestitures of the global embolic microspheres portfolio and the intrauterine health franchise. Guidance excludes the recently announced preventive acquisition and assumes an April 1 divestiture of the BTG specialty pharmaceutical business. On this call, all references to sales and revenue, unless otherwise specified, are organic. Average daily sales normalizes sales growth for a difference in selling days year over year. Finally, growth goals of six to 8%, excluding COVID, represent comparisons between time periods in which results are not materially impacted by the COVID-19 pandemic. Of note, this call contains forward-looking statements within the meaning of federal securities laws, which may be identified by words like anticipate, expect, believe, estimate, and other similar words. They include, among other things, the impact of the COVID-19 pandemic upon the company's operations and financial results, statements about our growth and market share, new product approvals and launches, clinical trials, cost savings and growth opportunities, our cash flow and expected use, our financial performance, including sales, margins and earnings, as well as our tax rates, R&D spend, and other expenses. Factors that may cause such differences include those described in the risk factors section of our most recent 10-K and subsequent 10-Qs filed with the SEC. These statements speak only as of today's date, and we disclaim any intention or obligation to update them. At this point, I'll turn it over to Mike for his comments.

Thank you, Susie. Thanks for joining us today. 2020, I'm very proud of how the BSC team has responded and how we're able to serve patients while keeping our employees safe and leveraging this year's challenges into a strengthening of our portfolio and digital capabilities. We're excited about the outlook in 2021 and beyond and expect to return to growth supported by our category leadership positions, innovative pipeline, and ongoing expansion into higher growth markets. pandemic and a strengthened position given our innovative and diversified portfolio and our global team. As we pre-announced on January 12, Q4 2020 sales declined 8% on an organic basis, which included 370 basis points of negative impact from the sales return reserve related to our conversion to a consignment inventory model Organic sales, excluding the impact of this Watchman consignment, grew low single digits in October, down low single digits in November, and then declined low double digits in December as the COVID-19 pandemic intensified in Europe and the U.S. in particular. Our fourth quarter sales results were largely consistent with our third quarter 20 results, which declined 6% organically, which included a 230 basis point impact from Watchman consignment. For the full year of 2020, operational sales declined 7.8%, and organic sales declined 11.3%, both of which include the 170 basis point impact from Watchman. Today, we also announced Q4 adjusted operating margin of 18.3% and adjusted BPS of 23 cents, which includes approximately 730 basis points and 13 cents of charges, respectively, related to Watchman consignment and Lotus Edge discontinuation. Importantly, we do not expect any material charges related to Watchman consignment or Lotus in 2021. Adjusted operating margin for the full year was 19.3%, with adjusted EPS of 96 cents, reflecting the impact of reduced procedure volume due to COVID, as well as the impact from the shift to Watchman consignment and Lotus. Full year 2020 cash flow was strong, despite the COVID impact, at $2 billion in adjusted pre-cash flow, with free cash flow at $1.1 billion. Our 2020 financials are clearly a negative outlier to our pre-pandemic six-year track record of excellent results. We believe we'll return to delivering strong results in 2021, thanks to our strategy of category leadership in key markets, portfolio diversification, and high-growth adjacencies. We continue to execute against our strategic plan objectives and drive towards ex-COVID financial goals for 6% to 8% organic sales growth, operating margin expansion, and double-digit adjusted EPS growth, with improved ability to deploy our healthy free cash flow. We're excited to turn the page in 2020 and confident in our plans to build on our global momentum in 2021 and beyond. we are reinstating guidance for Q1 and 2021 full year, which is based on our underlying COVID impact assumptions. These assumptions reflect an ongoing meaningful impact from the pandemic in first quarter, improvement in second quarter, and a return to more normal procedure levels in second half 21. Our guidance also excludes the recently announced preventive acquisition and assumes an April 1st investiture of the BTG Spec Pharma business. We're targeting 2021 organic revenue growth of 12% to 18% versus 2020, and flat to up 5% versus 2019, both excluding the impact of acquisitions and investitures. And Dan will give more details. Given the expected waning impact of COVID-19, we expect to see organic revenue accelerate over the course of the year, and we're guiding to full-year adjusted EPS of $1.50 to $1.60. For Q1 2021, sales trends in January continue to be challenging due to the impact of COVID. However, we anticipate that our sales trends will improve throughout Q1 as COVID trends stabilize and vaccine access improves. As a result, we forecast first quarter 2021 organic revenue in a range of down three to up three versus 2020, and down six to flat versus 2019, both excluding the impact of acquisitions with adjusted EPS of 28 to 34 cents. I'll now provide some brief highlights of Q4 and 2020 results, along with thoughts on our 21 outlook. So returning back to Q4, regionally, the U.S. is down 9% on an operational basis, inclusive of the 600 basis point watchman impact. Both Europe, Middle East, Africa, and Asia-Pac were also down 6% operationally. Operationally, emerging market sales declined 9%, and China was down 7%. China results include a 10% point negative impact from the DES tender sales return reserves. Outside this impact, China had excellent sales in IC imaging, complex coronary, PI, structural heart, urology, pelvic health, and we expect double-digit growth from China in 2021, given the momentum in these franchises, the diversification of our portfolio, and with drug-eluting stats now representing approximately 5% of our China revenue mix in 2021. I'll now provide some additional commentary in our business units. Urology and normalizing for the intrauterine health divestiture. Full-year sales declined 7%, and Q4 growth was led by continuous strength in Lithiview, SpaceOar, and Resume. In Q4, Lithiview grew double digits and crossed the threshold of treating 200,000 patients cumulatively. We recently launched SpaceOar View Hydrogel, which is visible under CT imaging, and helped drive full-year growth for that franchise north of 20% versus 2019. And for endoscopy, Q4 sales also grew 1% with a broad-based recovery across regions and notable strength in infection prevention. Full-year 2020 sales declined 6%. Our Exalt-D launch has received strong physician feedback, and we continue to expand our global account base. Unfortunately, hospital systems has COVID-19 restrictions have made adoption of Exalt-D more challenging. We do expect ExaltD to build momentum throughout 2021 and remain bullish on the significant multi-year runway, but the pandemic continues to be a short-term headwind in driving ExaltD access. We will also continue to build a body of clinical evidence and are very encouraged by uptake of the transitional pass-through payment for ExaltD in the outpatient setting. The launch of Spyglass Discover continues to go well, and we continue to target launch of our single-use bronchoscope in the second half of 2021. We're also pleased to have recently launched the RISE ProKnife, which complements our high-growth endoluminal surgery portfolio. In cardiac rhythm management, Q4 sales declined 6%, with both high- and low-voltage performance similar to overall CRM. Full-year sales declined 12%. In 2021, we anticipate beginning enrollment soon in modular ATP, our dual-track clinical study for a standalone leafless pacemaker, as well as survive anti-tachycardia patients. Our high-voltage business is now nearly three times the size of our low-voltage business, so increasing access to emblem SICD for appropriate patient populations is a significant driver for this leadless pacemaker work. Importantly, our LuxDX implantable cardiac monitor is off to an excellent launch, given its high-quality ECG signals, arrhythmia algorithm performance, and streamlined back-end monitoring. We're also excited about our recent acquisition a broad portfolio with Body Guardian Mini that covers all four modalities of ambulatory ECG monitoring and establishes a strong position for BSC in the field of cardiac diagnostics. We expect to close the deal by mid-21, after which we'll be uniquely positioned across all diagnostic therapies, including AECG, LUX-DX, our plantable cardiac monitor, and HeartLogic, as well as implantable and ablative therapies. Electrophysiology sales were down 2% in Q4 and 14% for the full year. In December, we did begin the full launch of Polarex, the second-generation single-shot cryoablation catheter in Europe, and physicians are noting Polarex ease of use and attractive procedure duration. StablePoint, our novel force-sensing therapeutic catheter with direct sense, was also recently approved in Japan and is receiving positive EU physician feedback early in the commercial launch. In neuromodulation, Q4 organic revenue declined 12%, but grew sequentially from Q3, while full-year neuromod sales were down 16%. The fourth-quarter decline is primarily due to a high rate of spinal cord stimulation patient cancellations in November and December due to the COVID surge. We expect the majority of these procedures to be rescheduled and are pleased to have launched our next-generation WaveRider Alpha. fast and contour paraseizure-free waveforms with MRI capability supported by our Cognita software solutions that enhance the physician's ability to identify, manage, and maintain SCS patients. We also recently received U.S. approval of our Versace Genus platform, which expands our MRI capabilities in both the rechargeable and non-rechargeable segments with Bluetooth communication between the implant, the patient remotes, Biology Q4 sales declined 23% organically, but that includes an approximate negative 1,600 basis point impact related to the transition to Watchman consignment and for the China tender reserve. Full-year ICU sales were down 18%, including a 720 basis point impact related to those same reserve items. The Watchman franchise accelerated its recovery in Q4 with 18% growth, excluding the impact of the Watchman consignment. Our U.S. launch of Watchman Flex has gone extremely well, with positive physician feedback on device performance and safety, and a higher than expected conversion rate in a shift to a consignment model. This program to shift is now concluded, and we target a complete conversion to Flex by mid-2021. We also continue to invest in clinical trials to expand the patient indication for Watchman Flex, and we expect a complete enrollment of the option trial by year-end. Within Coronary Therapies, we continue to improve our sales mix each year via the growth and innovation of our complex PCI franchise. Although drug-eluting stents continue to be a challenge from a pricing standpoint, DES now represents 7% of total company sales in 2020. We continue to differentiate with new product launches such as Synergy XD and 48mm, as well as the newly approved Megatron in the U.S. Our complex PCI portfolio is an important growth driver with new products such as Comma de Vigo and NextGen Rotor Pro. We expect our global PCI and imaging franchise to be 50% larger than DES in 2021. In TAVR, AccurateNeo 2 is performing very well in Europe given its excellent ease of use, low rates of PVL, and best-in-class pacemaker rates and hemodynamics. We continue to focus on the NEO2-US IDE enrollment, and in mitral later this year, we'll begin an early feasibility study in the U.S. for Millipede, a transcatheter anaplasty ring system for patients with functional mitral regurgitation. In peripheral interventions, Q4 organic sales grew 5%, which was an acceleration from Q3, and reflect an overall mix of high acuity as well as category-leading portfolio and a broad cadence of new product launches. Full-year PI sales declined 3%, and the BTG interventional medicine business grew 12% in the quarter, led by high teens' growth in ECOS on a new council, new reimbursement, and market penetration into pulmonary embolism. We continue to have best-in-class clinical evidence of our ecosystem that will add to our breadth and research with anticipation of HYPETRA trial, the first global head-to-head study of interventional therapy for pulmonary embolism compared to standard anticoagulation. In arterial, our drug alluvium portfolio grew mid-20s as we launched the Ranger DCB in the U.S. and saw uptake of the NTAP for alluvia. And the market continues to cover as additional long-term data sets continue to show no mortality risk associated with pacotexel devices. And we expect our drug alluvium portfolio to exceed $150 million in 2021. I'd also like to highlight briefly two important sustainability accomplishments this quarter. inclusion in the Dow Jones Sustainability Index, and the Newsweek's America's Most Responsible Company 2021 list. These recognitions are a gratifying reflection of our commitment to sustainable economic, environmental, and social practices. So overall, we're very optimistic on the outlook of 2021 and beyond. The high acuity nature of our portfolio, multiple product launches, and a diminishing impact from the COVID-19 pandemic shall help BSE to execute well and significantly improve performance in 21. We will continue to execute our category leadership strategy and diversify the portfolio into high-growth markets like the Preventus Acquisition, which is expected to have an exciting growth diagnostics platform with excellent long-term prospects. This deal is the latest example of our strength and balance sheet and compelling venture portfolio, which enabled to continue to develop multiple high growth market opportunities. In addition, the excellent work of our health We continue to drive towards ex-COVID financial goals for 6% to 8% organic revenue growth and margin expansion to drive strong cash flow and double-digit adjusted EPS. And finally, we continue to live our values with enduring commitment to sustainable business practices. I'm grateful to our employees and for their winning spirit, and I'll turn things over to Dan. Thanks, Mike.

Fourth quarter consolidated revenue of $2,708,000,000 represents a reported revenue decline of 6.8%. and reflects a $44 million tailwind from foreign exchange. On an operational basis, revenue declined 8.3% in the quarter. Excluding the impact of the divestiture of our intrauterine health franchise, organic revenue declined 8% and includes a $106 million, or a 370 basis point headwind from the sales return reserve related to our conversion our left atrial appendage closure franchise, with the launch of our next generation Watchman Flex device in the United States, which is now substantially complete. The mid-quarter discontinuation of Lotus Edge created a $15 million headwind in the quarter. As Mike detailed, these results are largely consistent with third quarter results as the impact of the COVID-19 pandemic increased in December after our revenue was trending flat to 2019 through October and November. adjusted earnings per share of 23 cents includes a negative six cent impact from the Watchman consignment sales return reserve, as well as a negative seven cent impact from the discontinuation of loaded veg, primarily related to inventory charges. Our full year 2020 consolidated revenue of $9,913,000,000 declined 7.7% on a reported basis and 7.8% including this net contribution, organic sales declined 11.3%, including a 170 basis point headwind from the transition to Watchman consignment. In addition to top line challenges resulting from the COVID-19 pandemic, full year 2020 adjusted earnings per share of 96 cents includes several charges, 10 cents related to the transition to Watchman consignment, 7 cents related to Lotus Edge inventory charges, and 2 cents due to inventory charges Fourth quarter was 64.9%. which means relatively more normal levels of manufacturing variances, although still negative, with volumes not yet back to historical levels. As a result, we expect to materially work through the lagging impact of unfavorable manufacturing variances excluding a 300 basis point headwind related to the Watchman consignment transition and a 450 basis point headwind related to the discontinuation of Lotus Edge. On a GAAP basis, operating margin was negative 0.3% and includes a $131 million goodwill impairment related to the announced sale of specialty pharmaceuticals, an additional $64 million in charges related to the discontinuation of Lotus Edge, and $18 million Adjusted interest and other expense totaled $108 million, resulting in full-year adjusted interest and other expense of $429 million, in line with expectations at the beginning of the year. The cost of the make-hole call for early paydown of a portion of our May 22 bonds was more than offset by a gain on investments in the fourth quarter, a separate $363 million gain based on our investment for the fourth quarter was 38.8% on a GAAP basis and 9.4% on an adjusted basis. Our full year tax rate was minus 1.7% on a GAAP basis and 5.2% on an adjusted basis, which is comprised of an operational rate of 11.2%, less 150 basis points of benefit from stock compensation, and 450 basis points benefit from discrete items recognized during the year, the most significant of which was an $88 million non-cash benefit driven by the Q3 completion of the IRS examination of our 2014 to 2016 tax years in a favorable position compared to our reserves. Adjusted free cash flow for the quarter was $552 million, and free cash flow was $500. $173 million from operating activities, less $153 million net capital expenditures. Despite the pandemic, we generated very solid full-year adjusted free cash flow of $2 billion in line with 2019 and free cash flow of $1.1 billion with $1.5 billion from operating activities, less $364 2020 adjusted free cash flow with headwinds of increasing inventory and accounts receivable as we return to more normalized volumes. As of December 31st, 2020, we had cash on hand of $1.7 billion and total liquidity, including available credit facilities, of $4.5 billion. Our top priority for capital deployment remains tuck-in M&A and We have capacity to pursue additional business development opportunities while continuing to remain active within our venture capital portfolio and take advantage of opportunistic share repurchase as we did in December. During the quarter, we repurchased $535 million in shares and paid early $250 million of our May 2022 bonds. The total is roughly equivalent. With respect to our legal reserves, we booked $18 million in Q4 to true up our MeSH reserve, including additional legal fees and some litigation outside the United States. Our total legal reserve, of which MeSH is included, was $569 million as of December 31, 2020. There's been no material change to the U.S. MeSH claims outlook over the last three years, but during 2020, we incorporated estimable international claims, one-time claims made by a coalition of state attorneys general, and adjustments to our legal fee reserve. Materially, all U.S. claims have been settled or are in the final stages of settlement, and we continue to work to fully resolve global MeSH claims. However, given the nature of resolving the final claims, And given COVID related delays in the courts, we expect full global resolution to lag into 2022. I'll now walk through guidance for full year 2021 and Q1 2021. As Mike stated, our guidance is based on assumptions that the impact of the COVID pandemic in Q1 2021 will drive similar results to Q4 2020, improve into Q2 2021, and that the second half of 2021 will return to relatively normal procedural volumes. With this high-level trend, we're widening our top-line guidance range to account for some degree of variability while still trying to provide insight and direction. Likewise, our EPS guidance range will be wider to allow for flexibility in spending levels as the COVID-specific cost containment We will continue to manage spending prudently, but we are making the necessary investments to ensure we are ready to capitalize on momentum in a post-COVID world. Our guidance assumes the divestiture of specialty pharmaceuticals closes April 1st, 2021, the midpoint of first half 2021 expectations, and does not include assumptions for acquisitions that have not yet closed, including preventive solutions. So for the full year, we expect 2021 organic revenue growth to be in the range versus 2020. This includes a tailwind of $179 million in watch minute sales return reserves that were booked in 2020, a headwind of $62 million from 2020 Lotus Edge sales, and excludes a 300 basis point tailwind from foreign exchange, as well as 190 basis points from the divestiture of our intrauterine health franchise and specialty pharmaceuticals. This guidance represents revenue growth of 0% to 5% versus calculation excludes 2019 sales of divested businesses, embolic beads, intrauterine health, and specialty pharmaceuticals, and excludes projected 2021 sales of acquired businesses, VertiFlex and BTG, prior to 24 months post-close. Therefore, full-year 2019 sales exclude $50 million in sales of our embolic beads portfolio and intrauterine health franchise, and as well as $81 million in specialty pharmaceutical sales. And at the midpoint of guidance, 2021 sales exclude approximately $305 million in sales of VertiFlex through May and BTG Interventional Medicines through mid-August, as well as $35 million specialty pharmaceutical sales through March. For Q1 2021, we expect organic revenue growth to of $21 million from Q1 2020 Lotus Edge sales and excluding a 400 basis point tailwind from foreign exchange, as well as 20 basis points from the divestiture of our intrauterine health franchise. This guidance represents down 6% to flat versus 2019, excluding the impact of acquisitions and divestitures. million in sales of our embolic beads portfolio and intrauterine health franchise. And at the midpoint of guidance, 2021 sales exclude approximately $125 million in sales of VertiFlex and BTG Interventional Medicines, as well as 35 million specialty pharmaceutical sales. In terms of adjusted operating margin, we expect Q1 2021 to be below 2019, Q2 to improve and the second half of 2021 to be at or exceeding the full-year 2019 level of 26.1%. We forecast our full-year 2021 operational and adjusted tax rate to be approximately 11%, with minimal benefit from the accounting standard for stock compensation, as this benefit is primarily recognized within the first quarter. We expect adjusted below-the-line capital portfolio and costs associated with our hedging program to be approximately $400 to $425 million for the year. We expect a fully weighted diluted, fully diluted weighted average share count of approximately 1,435,000,000 shares for Q1 2021 and 1,436,000,000 shares for full year 2021. We expect adjusted earnings per share for the first quarter to be in a range of $0.28 to $0.34, which includes approximately $0.01 from specialty pharmaceuticals, and for the full year to be in a range of $1.50 to $1.60 compared to $1.58 adjusted earnings per share earned in 2019 and excludes specialty pharmaceuticals Q2 to Q4. website for Q4 2020 financial and operational highlights, which outlines more detailed Q4 results. And with that, I'll turn it back to Suzy, who will moderate the Q&A.

Thanks, Dan. Andrew, let's open it up to questions for the next 30 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 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. 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.

Oh, great. Thanks. And good morning. Morning. So, Mike, just to start, if OK, I wanted to ask a big picture question, because obviously, historically, investors are used to Boston growing above MedTech peers. And with the 2021 guide you're giving us today is, I think you said, zero to five percent organic revenue growth over 2019. And zero to five is not a premium to what we're hearing from others. And it's actually below some that have guided for It's that same time period. So when do you think Boston can once again start to show revenues that look better than your peers? Is that now more of a 2022 event in your mind? Thank you.

Sure. Thanks, Bob. We believe pre-COVID, as you know, we grew faster than our peer group for multiple years in a row. And I think excluding we've had obviously challenges in 2020 with COVID. So we see as COVID wanes. And COVID eventually, as we go to the second half of the year, as the impact diminishes, as vaccines roll out and the business becomes more normal, we will then grow faster than our peer groups, just like we used to. So during the period where we're impacted, we were impacted 20 months of COVID impact in 2020, and we're seeing some impact in first quarter. And we think that's going to diminish quite a bit in second quarter as vaccines roll out and patient demand increases. And we expect a very healthy second half of the year. So the normal guidance of 0% to 5% over 19 is clearly not what we'd expect in a COVID-free environment. really reflects the impact of COVID in Q1 and some impact in Q2. It depends. Maybe Q2 will be better. It depends on what happens with the vaccine rollout. But it lays out a COVID impact for really the first half of the year and getting back to at-market, if not above-market growth in second half, consistent with what we've done in the past, you know, given the strength of the portfolio.

Okay, well, thank you for that. And I did want to ask a product-related question because there's been a couple of pieces of sort of negative news just in the last week, frankly, on SICD and Preventus. And so I'm just curious, how big a business is SICD and is the problem fixed? And then on Preventus, can that business keep growing 25%, 30% if the Novitas reimbursement decision isn't reversed? We'd love some thoughts on that, and thank you.

Sure, Bob. I'll take the Preventus one and turn it over to Dr. Stein in a minute for the SICD commentary. So on Preventus, we're very excited about this acquisition. As you know, the business, and we'll talk about the reimbursement piece too, the business grew $160 million in 2020. It grew over 30% growth. And as you know, there's also, besides the broadest diagnostic portfolio that the And we also add our implantable cardiac loop recorder. So we believe we have the most comprehensive diagnostic portfolio versus our peer group with that full suite of products. And importantly, if you look at Preventus, the long-term Holter segment is obviously very important. It represents, you know, call it 10% to 15% of their sales. And it's a fast-growing market. And the reimbursement situation there, I would call that fluid. And so we expect to see additional meetings in the near future. And we'll see where that plays out in terms of that reimbursement. We don't think the current reimbursement level is consistent with the clinical results, effectiveness, and amount of work and labor required for a long-term Holter. But I think that reimbursement position will be fluid. But I think what's unique to Preventus in Boston is the mix of the portfolio. So although the long-term Holter market was growing the fastest in May in the future, depending on what happens with the reimbursements, percent of the product mix was growing over 20 percent in the other modalities, including MCOT and others. And the uniqueness of their device is they're able to switch from a long-term holter, short-term holter across these four modalities given the software they have. So I think the mix of the products is helpful. The reimbursement in the other three categories is actually slightly improved. And so I think we have the the nice flexibility to move patients seamlessly across that continuum of diagnostics. The reimbursements improved in some areas. There is obviously a headwind with long-term Holter, and I think there will be quite a few discussions on that aspect in the future. So I think given the mix of products and the benefit for BSE, we're quite happy with that acquisition and comfortable that it will grow very healthy. In terms of SICD, Dr. Stein, I'll turn that over to you in terms of that question.

Yeah, thanks a lot, Mike, and thanks, Bob. And I think what you're referring to is the FDA classification of our recent advisory regarding the electrode that's a critical part of the SICD system. And I think it's really important just to emphasize, you know, to everyone who's listening, you know, in this particular case, we did not issue the advisory specifically because of the rate of the issue that we were seeing. The rate is actually only 0.2% at 41 months. And that rate is at least as good, if not actually better, than the best transvenous leads that are out there on the market. So in this case, we advised because with the advisory, we were able to give physicians better education on how to detect and how to diagnose the issue. as they follow their patients post-implant. The FDA classification then was expected. The FDA's determination is not based on rates of harm. I'd tell you overall, the impact that we see has been limited. The EP community as a whole recognizes the excellent overall performance of the SICD electrode and the unique benefits that this device offers. It is still the only ICD on the market that can provide defibrillation without touching the heart and vascular system. And those considerations, frankly, are why the FDA and international regulators have uniformly agreed that the electrode should remain on the market and ought to remain available for physicians and for patients.

The next question comes from David Lewis of Morgan-Stanlin. Please go ahead.

Good morning. Thanks for taking the question. Dan, I appreciate the comments in the first quarter. Basically, the guide implies kind of no improvement, it seems like, on the lower end, maybe to the mid part of the range. I'm just sort of curious, does the upper end of that range define kind of recovery middle part of the quarter? And what have you seen here in February relative to January?

Thanks, David. I wouldn't comment specifically on the months within the quarter, but what I would say is exactly what Mike said and I reiterated, which we think Q1 will look a lot like Q4, right? So if you look at the zero to down six, the midpoint of that is down three. We were down four in Q4. We were down three in Q3. So we're kind of in the COVID world, we believe, still in Q1, and our results will be impacted by that. You heard Mike's answer to Bob's question. I think a lot of optimism around the second half and getting past COVID, getting into that part of the curve, and getting back to above-peer revenue growth and margin expansion, because the goal for the second half, again, is to get operating margins above where we were in 2019. a pretty appropriate guide for Q1 and for the full year 2021 before we sit today.

Okay, and then just two quick follow-ups from me for Mike. Mike, just a quick follow-up on Preventus. It's 15% of the revenue base, but it's probably 30%, 50% of the growth rate of the asset, and we haven't seen the merger document yet. But to the extent that reimbursing rates can't get revised, do you have relief, and are you as committed to this transaction when the biggest growth driver obviously is a little impaired? That's number one. The other one is just on Watchman. These consignment comments that you made in the fourth quarter, the consignment was larger than expected. What does that tell us in terms of your commercial progress in terms of converting accounts over to Flex? Are you feeling a lot better about that Flex conversion getting there by mid-year based on what we saw in consignment? Thanks so much.

Yeah, I'll start with the Watchman one. That consignment really exceeded our expectations. We're complete with it. You won't see any more consignment charges this year nor any Lotus charges, so that's good. And really what it just shows is the broad adoption and enthusiasm for Watchman Flex. So we'll be easily done with a full Watchman conversion in the second quarter. It's well on its way now. And so most of our customers want it. use and the momentum that it has. So that really exceeded it. We expect to have a great year with Watchman in 2021 and beyond. The option trial will finish enrolling by year end. The champion trial is enrolling now. There's a portfolio of enhancements behind Watchman Flex, and there's a lot of momentum with that business. So that's really good. For Bendis, we're excited about it. As I mentioned before, as you said, the long-term Holter is the faster growing market. And Prevent has done a nice job in taking share in that market. And there is some exposure, as you said, about 15% of that product mix is long-term Holter, but only about half of that's impacted by the current reimbursement modification given the Medicare mix there. So, you know, call that 10-ish million of exposure within that one segment. As I mentioned before, the other segments had a modification of slight tailwind of improvements in reimbursement. And again, Preventus is the only company that can offer that variability, and so near-term, that's a win for Preventus. They have a market-leading portfolio there, and the businesses outside of long-term Holter are in 2020. So the other businesses, although the market growth of those segments aren't as strong as long-term halter prevent us, uh, gain share against this competitive set, uh, in 2020. And we have the ability to move across that portfolio. So obviously the long-term halter market is a strategic segment. It's the faster growing, uh, segment where we've gained share. Um, and we will work with the societies and, uh, uh, uh, industry as well as the, uh, and the costs associated. And maybe, Dr. Stein, if you want to comment more on that piece of it.

Yeah, thanks, Mike. Again, I think we're sort of disappointed, you know, a bit just in the failure to recognize the advantages that you get with a long-term versus a short-term Holter. I mean, the math on this isn't really hard. If you do a 14-day Holter monitor, you get seven times as much data as you get when you do a two-day Holter recording. And particularly if you're doing the study looking for intermittent conditions like atrial fibrillation, it's probably the most common reason to order one of these tests. The diagnostic yield is far greater with the longer-term recording. And I think over the long run, I don't think that's a heavy lift to convince payers of that proposition. In the short term, again, it just gets back to what Mike said earlier, Preventus really has some unique competitive differentiation, particularly in the fact that their Body Guardian mini product can do all four of the modes of monitoring, short-term Holter, long-term Holter, event monitoring, and MCOT, mobile cardiac outpatient telemetry. And so the ability to do that switch remotely is a big advantage in light of these kinds of payer decisions and also just put that on top of the really, I think, industry-leading AI abilities, which are useful, you know, within the ambulatory monitoring space and also just really brings an enhanced capability to Boston Scientific as a company.

Great. Thanks so much. Yep.

The next question comes from Larry Beagleson of Wells Fargo. Please go ahead.

Good morning. Thanks for taking the question. One on the guidance for Dan and, well, maybe two on the guidance. First, Dan, the guidance implies sales of about $11.5 billion at the midpoint, if I'm doing the math right, which is above your 2019 sales. But EPS are expected to be slightly below at the midpoint for 2021 relative to 2019. I know you gave a lot of helpful color on how to think about the P&L, but At a high level, why would sales be meaningfully above in 2021 but EPS slightly below? And I had one follow-up.

Sure. I think probably the best way to go through that, Larry, is maybe just give you a quick walk through the components of operating margin, which is really the driver there. So in terms of adjusted operating margin, we expect Q1 will be dilutive to 2019. could largely be characterized as a post-COVID world when we get to the second half of 21 that will be at or exceeding the full year. term. It's interesting. If you go back and you take a look at 2020 and you adjust out, you know, Lotus and Watchman and then the abnormal variances we talked a lot about in Q2 from the those quarters. So I think we've proven that in a COVID impacted world, gross margin is in that approaching 70% range. And so that's probably where it is in the first quarter as well, is in that approaching 70 range, because we're still in a COVID world, we have lower volumes, we actually have more COVID related costs, things And the manufacturing plants we have to do related to COVID, including higher freight and other things that in the time that we're impacted by COVID, we're likely in that world. Now, the good news is in 2020, and you saw from the cash flow, we were able to deliver very strong cash flow. And a lot of that was working capital, but also reducing costs. 2020 to do that. Well, as those kind of lapsed at the end of 2020, we haven't put a lot of those back in place because we want to invest. We want to be going towards the point where we're in that post-COVID world investing for momentum. We're spending smartly. We're obviously making the right investments, mostly commercially and research and development focused. But you're likely to potentially short, when you look at the profile of the elements of operating margin, gross margin is likely challenged in the first quarter, second quarter. We'll start to improve in the back half, as it always does anyway, historically, sequentially as you go through the year. So we think that's a likelihood. And then from an OPEX perspective, as you get higher sales, you'll have the SG&A percentage So gross margin a little bit less contribution than we might have thought a year ago, and SG&A probably lower than we thought a year ago. But, again, key back to operating margin expansion in the second half versus 2019.

Perfect. And then, you know, Mike, given how elective your procedures are, you know, what are your expectations for a potential catch-up in deferred procedures that, you know, were obviously deferred in 2019? Thanks for taking the questions. Thanks.

Pretty confident that will happen. You saw in second quarter the impact of some of our businesses like spinal cord stimulators and Euro PH. fell, I think Nerva was down 40% in the second quarter and Euro was down 30%. And you saw them snap back very quickly when the COVID impact improved in the third quarter. And then obviously COVID came back stronger again. So I'd say the business responds very quickly once the COVID impact stabilizes and decreases and as vaccines will become more prominent, you'll see a sharp recovery of these businesses. As you saw, fourth quarter grew. You know, PI grew 5%. The BTG interventional grew double-digit. Packet tax grew plus 20%. Endo and Euro grew. So some of our businesses are just more impacted, namely spinal cord stimulation, urology, and some of our core CRM IC businesses. And as COVID improves, we've seen that it steps back pretty quickly, and that's where you see a very bullish second-half guide when we feel the impact will be minimized. Thank you.

The next question comes from Joanne Winch of Citibank. Please go ahead.

Good morning, everybody. Two questions. Exalt D, you've been very forthright in sharing how the pandemic has slowed uptake of this. And can we think about how, in an improving environment, you look to launch it in a more constructive way?

Yeah, so the teams, I would say, doing the best they can, I would say, in the environment. We've placed a number of capital units in U.S. and some of the Western markets in Europe. So the capital is in place, and the sales team is in place. The outpatient reimbursement is quite healthy for that product, which is great, and they're building new clinical evidence. In the near term here, the challenge continues to be access. having our teams accessible to the suites to really drive what is kind of a behavior change in using a single-use scope. And so as COVID continues to improve, this will be a great growth driver for us in 2021. And it'll get better and better each quarter, just like we're seeing now. However, the ability for us to really turn on accounts in high utilization is difficult, given the limitations of some of the rep access and the hesitancy to modify kind of current practices in a COVID world. But we have seen some success for sure. And our team, the reimbursement is very helpful. And as the year goes on, that will become a more meaningful growth driver each quarter for us. And we'll launch the Broncoscope in the second half of 2021. And we believe this will be a nice $2 billion market for us. And we think it will follow a very similar path. ex-COVID as our urology scope did, as well as our spyglass scope and endo as well. So we have a lot of experience there. We know how to make these devices. You'll see enhancements to Exal-D likely in the second half of the year as well. And as COVID continues to wane down, that business will accelerate in 21.

Thanks. And my second question has to do with the peripheral intervention business. That's the business that seems to be gaining momentum and gaining it on the back of BTG also. And how do you think about that rolling out throughout the year? Because these two seem to me to be the main drivers to getting to that second half strength that you're talking about. Thank you.

Sure, I'll talk about PI. Look at the main drivers. Watchman Flex is going to have a fantastic year in 21. PI will likely be our fastest growing division, and I'll talk about that in a minute. Endo and Euro will do extremely well. And then SCS and Neuromod have some terrific launches, and we can talk about Cryo and some other things. But on PI specifically, they're set up for a very strong year. They grew 5% with COVID impact in fourth quarter. They have the most differentiated portfolio in arterial with the Ranger Balloon and the Lubia, including the NTAP with the Lubia. And we expect that business, as I mentioned, will more than double. It'll exceed $150 million this year. So we're really well positioned there. The venous space continues to grow extremely well. And then in interventional oncology, which is really the gem that we acquired with BTG, it's really exceeded expectations in terms of sales results. Now we're expanding it more aggressively in Europe and Asia-Pac. Just got some great reimbursement in Korea, Poland, and some other countries. We're expanding indications there. So the composite businesses within PI will be very healthy in 21.

Thank you.

The next question comes from Robbie Marcus of JPMorgan. Please go ahead.

Oh, great. Thanks for taking the question. You know, not to beat a dead horse here, but I wanted to touch on guidance for a second and really just hit on the strategy that you took when approaching it. You know, it's still we're in the middle of COVID, and I understand you're planning for a more normal second half. But just want to understand, you know, especially after last year and 2019, how much room is there on the downside should the virus really, the impact extend, vaccine rollout continues at a slow pace? You know, how much downside have you planned for in guidance? Just trying to think, you know, how conservative it is versus some of the worser case scenarios.

Sure, Ravi, I can take that. I think it's an appropriate amount. So as we look at coming into the year, obviously first time giving guidance in a year, we want to have a range out there that we're confident we can hit. And we believe in the ranges we've given for Q1 sales and EPS and full year sales and EPS. that those are ranges that we can hit that contemplate different outcomes. Yes, they're wider than they normally are. That's intentional, as we mentioned, given the uncertainty of where we are in a COVID environment. But we felt it important to kind of be on the record of what we think we can do, give you some insight into how we see the business, both in the short term and, again, into the second half and full year. So I believe there's an appropriate amount of room on both sides within the guidance ranges.

Got it. And then maybe just to follow up, you know, as we look at some of the new product launches, it looks like you have basically your 2020 slate will be launching here. We have Waverider. We have Exalti, which you touched on. You know, how should we think about 2022 and beyond? I know you have the slide there, but how delayed has some of your new product launches been? How has patient enrollment been? And do you expect any gaps in new product launches due to the trial enrollment environment? Thanks.

I would say on the good news, a lot of the things that we launched in 2020, you're going to get big impact in 2021. Some of the launches were impacted in 20. So we have no shortage of product launches that we're launching right now. clinical trial, I would say it's a bit mixed. The Watchman clinical trials have ramped very, very quickly with the option trial, the champion trial starting. Some of the trials that require new therapies have been a bit slower. We are excited about the Mitral approval to begin that clinical trial in the U.S., which is a nice win for us. We had some challenges trying to do that overseas given the COVID impact. The Exalt B we already talked about. So, you know, I would say it's a bit of a kind of a mixed result depending on which business you're in. But in some of the markets, it may be about a six-month impact in terms of enrollment timing. We're enrolling the U.S. trial for Accurate. We're enrolling the U.S. trial for Cryo. So maybe there's some impact maybe the six-months

So the only thing I'd add, Mike, is protected TAVR trials. I agree with what you said. It's been a mixed bag, but some trials are going a lot faster. Protected TAVR is one of those trials with cerebral embolic protection where recruitment is going ahead, well ahead of schedule. So it is a mixed portfolio of trials.

All right, Andrew, one final question, please.

Yes, and that question will come from Matt Taylor of UBS.

Please go ahead. Thank you for taking the question. I wanted to ask one on the assumptions for this year. You called out China as growing double digits, which is encouraging face of the stent headwind. I was wondering if you could give us any high-level thoughts on the different geographies. Are you expecting major differences in Europe versus the U.S. versus – you know, Latin America in recovery, any specifics that you can give us there?

Sure. Just for 21, you're assuming? For 21, I think, you know, I'd say the LATAM region, you know, is struggling a bit more with COVID impact than some other regions from a geographic kind of standpoint. been more effective. The China business, we're comfortable with strong double-digit growth in 2021. The DES business, as I mentioned, is only about 5% of our mix. And you've got great balance of our complex coronary PI and other businesses there. So China will have a strong year this year. You are seeing some minor flare-ups in China with COVID in the near term, but they've done a remarkable job of managing it. You are seeing some flare-ups of COVID in Japan as well. But, you know, so I think overall Asia business likely could be stronger given the impact of COVID. And U.S. and Europe have been kind of similar in terms of the COVID impact and the pace of recovery.

Okay, thanks. And I just wanted to ask kind of a continuation of an earlier question. When you're assuming that improving organic growth as COVID is Wayne, do you think that's going to spill over into 22 so you could see a stronger first half of the year in 22 as some of that excess demand or held-back demand gets cleaned up?

That's certainly the scenario we'd like to see. We're not given 22 guidance here, but obviously 22 will be refreshing. There will be no COVID impact at all, we assume, in the year. And we'll be above our peer group, back to that kind of six to eight ex-COVID range. And there certainly is a potential where the volumes are greater, given the desire to have these procedures done. So that will be refreshing.

we'd like to conclude the call on that. Thanks, Andrew. Please go ahead.

Oh, yes. Just to conclude the Q&A session, I'd like to turn the conference back over to Susan and Lisa for any closing remarks.

Thank you for your attention and your interest in the company.

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