Boston Scientific Corp (BSX) 2020 Q4 法說會逐字稿

Good morning, and welcome to the Boston Scientific Fourth Quarter 2020 Financial Results Conference Call. (Operator Instructions) 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 & Filings.

The duration of this morning's call will be approximately 1 hour. Mike will focus his 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 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 excludes the impact of foreign currency fluctuation, and organic revenue further excludes the impact of certain acquisitions, including Vertiflex through June and BTG through August 15, 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 Preventice 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 6% 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. As we finish up the challenging 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.

We are well positioned to emerge in the headwinds of the pandemic in a strengthened position given our innovative and diversified portfolio and our global team. As we preannounced 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 for our next-generation WATCHMAN FLX device in the U.S.

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 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 EPS of $0.23, which includes approximately 730 basis points and $0.13 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 $0.96, 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 free cash flow with free cash flow at $1.1 billion. Our 2020 financials are clearly a negative outlier to our pre-pandemic 6-year track record of excellent results. We believe we will return to delivering strong results in 2021, thanks to our strategy of category leadership in key markets, portfolio diversification into 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 '21 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 Preventice acquisition and assumes an April 1 divestiture 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 divestitures, 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 '21, sales trends in January continued 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 '21 organic revenue in a range of down 3% to up 3% versus 2020 and down 6% to flat versus 2019, both excluding the impact of acquisitions, with adjusted EPS of $0.28 to $0.34.

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 sales -- 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 stents now representing approximately 5% of our China revenue mix in 2021.

I'll now provide some additional commentary on our business units. Urology and Pelvic Health sales grew 1% on an organic basis in the quarter, normalizing for the intrauterine health divestiture. Full year sales declined 7%, and Q4 growth was led by continued strength in LithoVue, SpaceOAR and Rezum. In Q4, LithoVue grew double digits and crossed the threshold of treating 200,000 patients cumulatively. We recently launched SpaceOAR Vue 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 is receiving a strong physician feedback, and we continue to expand our global account base. Unfortunately, hospital systems during COVID-19 restrictions have made adoption of EXALT-D more challenging. We do expect EXALT-D to build momentum throughout 2021 and remain bullish on the significant multiyear runway, but the pandemic continues to be a short-term headwind in driving EXALT-D 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 EXALT-D 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 ORISE 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 stand-alone leadless pacemaker as well as provide antitachycardia pacing to EMBLEM S-ICD patients. Our high-voltage business is now nearly 3x the size of our low-voltage business, so increasing access to EMBLEM S-ICD for appropriate patient populations is a significant driver for this leadless pacemaker work.

Importantly, our LUX-Dx implantable cardiac monitor is off to an excellent launch given this high-quality ECG signals, arrhythmia algorithm performance and streamlined back-end monitoring. We're also excited about our recent acquisition of Preventice Solutions, which grew 30% in 2020 to $158 million by offering best-in-class detection algorithms, a broad portfolio with Bodyguardian Mini that covers all 4 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 and LUX-Dx, our implantable 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 POLARx, the second-generation single-shot cryoablation catheter in Europe, and physicians are noting POLARx ease of use and attractive procedure duration. StablePoint, our novel forceps in therapeutic catheter with DIRECTSENSE, 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 was 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 WaveWriter Alpha SCS system at NANS last month.

Alpha offers FAST and Contour paresthesia-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 Vercise Genus platform, which expands our MRI capabilities in both the rechargeable and nonrechargeable segments, with Bluetooth communication between the implant, the patient remote and the physician programmer.

Turning to Interventional Cardiology. 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 IC sales were down 18%, including a 720 basis point impact related to the 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 FLX has gone extremely well, with positive physician feedback and device performance and safety in a higher-than-expected conversion rate in the shift to consignment model.

This program to shift has now concluded, and we target a complete conversion to FLX by mid-2021. We're also continuing to invest in clinical trials to expand the patient indication for WATCHMAN FLX. We expect to 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. And we continue to differentiate with new product launches, such as SYNERGY XD and 48-millimeter 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 COMET and AVVIGO and next-gen ROTAPRO. We expect our global PCI and imaging franchise to be 50% larger than DES in 2021. In TAVR, ACURATE neo2 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 U.S. IDE enrollment. And in mitral later this year, we'll begin an early feasibility study in the U.S. for Millipede, a transcatheter angioplasty 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 EKOS and a new console, new reimbursement and market penetration into pulmonary embolism. We continue to have best-in-class clinical evidence of our EKOS system will add to our breadth and research with anticipation of HI-PEITHO trial, the first global head-to-head study of interventional therapy for pulmonary embolism compared to standard anticoagulation.

In arterial, our drug-eluting portfolio grew mid-20s as we launched the Ranger DCB in the U.S. and saw uptake of the NTAP for Eluvia. And the market continues to cover as additional long-term data sets continue to show no mortality risk associated with paclitaxel devices. Now we expect our drug-eluting portfolio to exceed [$115 million] in 2021.

I'd also like to highlight briefly 2 important sustainability accomplishments this quarter: inclusion in the Dow Jones Sustainability Index; and the Newsweek's America's Most Responsible Companies 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 for 2021 and beyond. The high acuity nature of our portfolio, multiple product launches and a diminishing impact from the COVID-19 pandemic should all help BSC 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 Preventice acquisition, which is expected to add exciting growth diagnostics platform with excellent long-term prospects. This deal is the latest example of our strength in balance sheet and compelling venture portfolio, which enable to continue to develop multiple high-growth market opportunities. In addition, the excellent work of our health care economics and reg teams in 2020 led to multiple product approvals and reimbursement wins. That also positions us well to go forward.

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 now I'll turn things over to Dan.

Thanks, Mike. Fourth quarter consolidated revenue of $2.708 billion 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 to a consignment inventory model for our left atrial appendage closure franchise with the launch of our next-generation WATCHMAN FLX 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. Q4 adjusted earnings per share of $0.23 includes a negative $0.06 impact from the WATCHMAN consignment sales return reserve as well as a negative $0.07 impact from the discontinuation of LOTUS Edge, primarily related to inventory charges.

Our full year 2020 consolidated revenue of $9.913 billion declined 7.7% on a reported basis and 7.8% on an operational basis, which includes 350 basis points related to the acquisitions of Vertiflex and BTG and is net of the divestiture of our legacy embolic beads portfolio and intrauterine health franchise. Excluding 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 $0.96 include several charges: $0.10 related to the transition to WATCHMAN consignment, $0.07 related to LOTUS Edge inventory charges and $0.02 due to inventory charges related to the lower demand at the onset of the pandemic. This is partially offset by a net $0.05 tax benefit.

Adjusted gross margin for the fourth quarter was 64.9%, including a 440 basis point negative impact from LOTUS Edge inventory charges. Excluding these inventory charges, Q4 adjusted gross margin was equal to Q3 adjusted gross margin of 69.3% and in line with our expectations despite a larger impact from the transition to WATCHMAN consignment.

Looking forward, we expect production in Q1 of 2021 to be at similar levels to Q4 2020, 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 capitalized on the balance sheet within the first half of 2021.

Fourth quarter adjusted operating margin was 18.3% or 25.6%, 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 in litigation-related expenses.

Moving to below the line. 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-whole 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 in Pulmonx is included in our GAAP results and excluded from adjusted results.

Our tax rate 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 noncash 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 $520 million, with $673 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 million in net capital expenditures.

For 2021, we aim to meet or exceed 2020 adjusted free cash flow with headwinds of increasing inventory and accounts receivable as we return to more normalized volumes. As of December 31, 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. 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 to the expected proceeds of the divestiture of Specialty Pharmaceuticals, which is expected to close in the first half of 2021. 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 3 years. But during 2020, we incorporated estimable international claims, onetime 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 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 measures implemented in Q2 2020 were largely concluded as of year-end. 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 1, 2021, the midpoint of first half 2021 expectations, and does not include assumptions for acquisitions that have not yet closed, including Preventice Solutions. So for the full year, we expect 2021 organic revenue growth to be in the range of 12% to 18% versus 2020. This includes a tailwind of $179 million in WATCHMAN 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 2019, excluding the impact of acquisitions and divestitures and includes a $50 million headwind from 2019 LOTUS Edge sales. This 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 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 Pharmaceuticals sales through March.

For Q1 2021, we expect organic revenue growth to be in a range of minus 3% to plus 3% versus 2020, including a headwind 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. For this calculation, 2019 sales exclude $15 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 Pharmaceuticals 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 expenses, which include interest payments, dilution from our venture capital portfolio and costs associated with our hedging program to be approximately $400 million to $425 million for the year. We expect a fully weighted diluted -- fully diluted weighted average share count of approximately 1.435 billion shares for Q1 2021 and 1.436 billion 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 of 2021. Please check our Investor Relations website for Q4 2020 financial and operational highlights, which outlines more detailed Q4 results.

And with that, I'll turn it back to Susie, who will moderate the Q&A.

Thanks, Dan. Andrew, let's open it up to questions for the next 30 minutes or so. (Operator Instructions) Andrew, please go ahead.

(Operator Instructions) The first question comes from Bob Hopkins of Bank of America.

So Mike, just to start, if okay, I wanted to ask a big-picture question. Because obviously, historically, investors are used to Boston growing above med tech peers. And with the 2021 guide you're giving us today is, I think you said 0% to 5% organic revenue growth over 2019. And 0% to 5% is not a premium to what we're hearing from others, and it's actually below some that have guided for that same time period. So when do you think Boston can once again start to show revenue did look better than your peers? Is that now more of a 2022 event in your mind?

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 challenged in 2020 with COVID. So we see as COVID wanes and COVID eventually towards second -- 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 group just like we used to. So during the period where we're impacted, we're impacted 20 months of COVID impact in 2020, and we're seeing some impact in first quarter. And we think that's good, diminish quite a bit in the 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 do expect in a COVID-free environment. So it really reflects the impact of COVID in Q1 and some impact in Q2. It depends. Maybe Q2 will be better, depends on what happens to 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, given the strength of the portfolio.

Okay. And I just -- 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 S-ICD and Preventice. And so I'm just curious, how big a business is S-ICD? And is the problem fixed? And then on Preventice, can that business keep growing 25%, 30% if Novitas reimbursement decision isn't reversed? Would love some thoughts on that.

Sure. Bob, I'll take the Preventice one and then turn it over to Dr. Stein in a minute for the S-ICD commentary. So on Preventice, 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 they offer with a short-term Holter long-term -- Holter MCOT event monitoring, 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 Preventice, the long-term Holter segment is obviously very important. It represents 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 long-term Holter. But I think that reimbursement position will be fluid. But I think what's unique to Preventice and 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 reimbursement, we also have well over 80% of the product mix was growing over 20% in the other modalities, including MCOT and others. And the uniqueness of their device, they're able to switch from a long-term Holter, short-term Holter across these 4 modalities, given the software they have. So I think the mix of the products is helpful. The reimbursement in the other 3 categories is actually slightly improved. And so I think we have 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 BSC, we're quite happy with that acquisition and comfortable that it will grow very healthy. In terms of S-ICD, Dr. Stein, I'll turn that over to you in terms of that question.

Yes. 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 S-ICD system. And I think it's really important just to emphasize to everyone who's listening. In this particular case, we did not issue the advisory 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, right?

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 S-ICD 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 Stanley.

Dan, I appreciate the comments in the first quarter. Basically, the guide implies kind of no improvement. It seems like on the -- sort of on the lower end, maybe to the mid part of the range. I'm just sort of curious, is 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 reiterate it, which we think Q1 will look a lot like Q4, right? So if you look at the 0% to down 6%, the midpoint of that is down 3%. We were down 4% in Q4, we were down 3% 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, just in a COVID world which we're still in here in Q1. I think those numbers are pretty appropriate guide for Q1 and for the full year 2021 with where we sit today.

Okay. And then just 2 quick follow-ups for me for Mike. Mike, just a quick follow-up on Preventice. 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 reimbursement 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. Is these consignment comments that you made in the fourth quarter, if consignment was larger than expected, what does that tell us in terms of your commercial progress in terms of converting accounts over to FLX? Are you feeling a lot better about that FLX conversion getting there by midyear based on what we saw on consignment?

Yes. 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 that the broad adoption and enthusiasm for WATCHMAN FLX. So we'll be easily done with the full WATCHMAN conversion in the second quarter. It's well on its way now. And so most of our customers want to switch to FLX, given the safety profile and the ease of 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, we'll finish enrolling by year-end. The CHAMPION trial is enrolling now.

There's a portfolio of enhancements behind WATCHMAN FLX, and there's a lot of momentum with that business. So that's really good. On Preventice, we're excited about it. And as I mentioned before, as you said, the long-term Holter is the faster-growing market. And Preventice 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 is impacted by the current reimbursement modification given the Medicare mix there.

So call that $10-ish million of exposure within that 1 segment. As I mentioned before, the other segments had a modification of slight tailwind of improvement in reimbursement. And again, Preventice is the only company that can offer that variability. And so if the market shifts a bit more towards MCOT in the near term, that's a win for Preventice. They have a market-leading portfolio there and the businesses outside of long-term Holter grew nearly 20% in 2020. So the other businesses, although the market growth of those segments aren't as strong as long-term Holter, Preventice gained share against its competitive set in 2020. And we have the ability to move across that portfolio.

So obviously, the long-term Holter market is a strategic segment. It's the faster-growing segment where we've gained share. And we'll work with the societies and industry as well as the appropriate authorities to educate as best we can on the clinical efficacy and the costs associated. And maybe Dr. Stein, do you want to comment more on that piece of it?

Yes. Thanks, Mike. Again, I think we're sort of disappointed 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 7x as much data as you get when you do a 2-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. Preventice really has some unique competitive differentiation, particularly in the fact that their BodyGuardian Mini product can do all 4 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 they're really, I think, industry-leading AI abilities, which are useful within the ambulatory monitoring space and also just really brings an enhanced capability to Boston Scientific as a company.

The next question comes from Larry Biegelsen of Wells Fargo.

One on the guidance for Dan and -- well, maybe 2 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 to 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. Q2 improves and then I think the key point is that in what is -- 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 operating margin of 26.1% in the second half. So why is that? And again, that corresponds to that period where you have more normalized volumes.

And the key really is gross margin in the short term. It's interesting, if you go back and you take a look at 2020 and you adjust out LOTUS and WATCHMAN. And then the abnormal variances we talked a lot about in Q2 from the lower production volumes, you kind of get a gross margin that's around 70% each of 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 in 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 it from the cash flow, we were able to deliver very strong cash flow, and a lot of that was working capital, but also reducing our operating expenses. So we took strong measures in 2020 to do that. Well, as those kind of lapse 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 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 see a little bit of an uptick in spend as a percentage of sales in the first half of '21.

However, as we've talked about over the last 6 months, there's less in travel and there's less in other areas. So long story short, when you look at the profile of the elements of operating margin, gross margin is likely challenged in the first quarter or second quarter. It will 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 to be lower as a percentage of that, which then gets us above that 26.1% in the second half.

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, Mike, given how elective your procedures are, what are your expectations for a potential catch-up in deferred procedures that were obviously deferred in 2019?

Yes. We're pretty confident that will happen. You saw in the second quarter, the impact of some of our businesses like spinal cord stimulators and Uro/PH fell, I think, neuromod was down 40% in the second quarter and Uro 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 vaccine -- once the COVID impact stabilizes and decreases and as vaccines will become more prominent, you'll see a sharp recovery of these businesses.

Many of our businesses, as you saw, fourth quarter grew. PI grew 5%. The BTG interventional grew double digit. Paclitaxel grew plus 20%, Endo and Uro 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.

Next question comes from Joanne Wuensch of Citibank.

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?

Yes. So the teams -- I would -- doing the best they can, I would say, in the environment. We 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. And there's -- near term here, the challenge continues to be access, having our teams accessible to the suites to really drive what is a 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 we'll get better and better each quarter, just like we're seeing now.

However, the ability for us to really turn on accounts and higher utilization is difficult given the limitations of some of the rep access and the hesitancy to modify kind of current practices in the 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 bronchoscope in the second half of 2021, and we believe this will be a nice $2 billion market for us. And it's -- 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 EXALT-D likely in the second half of the year as well. And as COVID continues to wane down, that business will accelerate in '21.

And my second question has to do with the Peripheral Intervention business. That's a business that seems to be gaining momentum and gaining in on the back of BTG also. And how do you think about that rolling out throughout the year? Because these 2 seem to me to be the main drivers to getting to that second half strength that you're talking about?

Sure. I'll talk about PI. I think when you look at the main drivers, WATCHMAN FLX 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 Uro 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 and specifically, they've got -- just -- 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 Eluvia, including the NTAP with Eluvia. And we expect that business, as I mentioned, will more than double. It will 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.

The next question comes from Robbie Marcus of JPMorgan.

Great. 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. 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, especially after last year '19, how much room is there on the downside should the virus really -- the impact extend, vaccine rollout continues at a slow pace. How much downside have you planned for in guidance? Just trying to think how conservative it is versus some of the worser case scenarios?

Sure, Robbie, I can take that one. In terms of the answer, 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 a follow-up. 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 EXALT-D, which you touched on. How should we think about 2022 and beyond? I know you have the slide there, but how delayed has some of your new product launch has been? How is patient enrollment been and do you expect any gaps in new product launches due to the trial enrollment environment?

I would say on -- the good news is a lot of the things that we launched in 2020 are going to get big impact in '21 and '22 because there are -- some of the launches were impacted in '20. So we have no shortage of product launches that we're launching right now that will impact '22 as well.

In terms of the clinical trial, I would say it's a bit mixed. The WATCHMAN clinical trials have ramped 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 in the -- 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-D, we already talked about.

So 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 maybe about a 6-month impact in terms of enrollment timing. We're enrolling the U.S. trial for ACURATE, we're enrolling the U.S. trial for cryo. So maybe there's some impact, maybe the 6-month range for, I would think, most companies in terms of clinical trial work. Dr. Stein or Dr. Meredith, any thoughts on that?

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

Andrew, one final question, please.

And that question will come from Matt Taylor of UBS.

I wanted to ask one on the assumptions for this year. You called out China is growing double digits, which is encouraging phase 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 Latin America in recovery? Any specifics that you can give us there?

Sure. Just for '21, you're assuming. For '21, I think I'd say the LATAM region is struggling a bit more with COVID impact than some other regions. From a geographic kind of standpoint, Asia has 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 -- 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. And I just wanted to ask kind of a continuation of an earlier question, when you're assuming the improving organic growth as COVID wins. 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 have [right back in the] '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 6% to 8% 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 a potential nice tailwind for the company.

All right -- we'd like to conclude the call. Thanks, Andrew. Please go ahead.

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

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

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