Boston Scientific Corporation

Good morning, everyone, and welcome to the Boston Scientific first quarter 2023 earnings call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key, 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 and then one on your telephone keypad. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Lauren Tengler, Vice President, Investor Relations. Please go ahead.

Thank you, Jamie. Welcome, everyone, and thanks for joining us today. 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 Q1 2023 results, which included reconciliations of the non-GAAP measures used in the release. We have posted a copy of that release, as well as reconciliations of the non-GAAP measures used in today's call, to the investor relations section of our website under the heading Financials and Filings. The duration of this morning's call will be approximately one hour. Mike and Dan will provide comments on Q1 performance, as well as the outlook for our business, including Q2 and full year 2023 guidance. And then we'll take your questions. During today's Q&A session, Mike and Dan will be joined by our Chief Medical Officer, Dr. Ken Stein. Before we begin, I'd like to remind everyone that on the call, operational revenue growth excludes the impact of foreign currency fluctuations, and organic revenue growth further excludes acquisitions and divestitures for which there are less than a full period of comparable net sales. Relevant acquisitions excluded for organic growth are Bayless Medical, which closed on February 14, 2022, the majority stake investment in Architect Scientific Holding Limited, and Apollo Endosurgery, which closed in February and April of this year, respectively. Please note that we have elected to consolidate ACOTEC results of operations on a one-quarter lag, thus having no impact to our Q1 reported or adjusted results. Guidance excludes the previously announced agreement to purchase a majority stake in MITEC, which has not closed. For more information, please refer to our Financial and Operating Highlights Deck, which may be found on our Investor Relations website. On this call, all references to sales and revenue, unless otherwise specified, are organic. This call contains forward-looking statements within the meaning of the federal security clause, which may be identified by words like anticipate, expect, may, believe, estimate, and other similar words. They include, among other things, statements about our growth in market share, new and anticipated product approvals and launches, acquisitions, clinical trials, cost savings and growth opportunities, our cash loan expected use, our financial performance, including sales, margins, and earnings, as well as our tax rates, R&D spend, and other expenses. If our underlying assumptions turn out to be incorrect or certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. Factors that may cause such differences include those described in the risk factor section of our most recent 10-K and subsequent 10-Qs filed with the SEC. These statements speak only as of today's date, and we disclaim any intention or obligation to update them. At this point, I'll turn it over to Mike.

Thanks, Lauren. Thank you to everyone for joining us today. Our first quarter performance exceeded our expectations across all business units and regions, which is a testament to the winning spirit of our global team and the relentless focus on innovation and execution. We also launched more than 70 new products globally in 2022. In the first quarter of 2023, total company operational sales grew 15%, versus 2022, while organic sales grew 14%, exceeding the high end of our guidance range of six to eight. We believe that all business units grew faster than the respective markets with differentiated portfolios and a strong commercial execution supported by healthy procedural demand. First quarter adjusted EPS of 47 cents grew 19% versus 2022, exceeding the high end of the guidance range of 42 to 44 cents. First quarter adjusted operating margin was 25.5%, which is in line with expectations. Now for our 2023 guidance. For second quarter 23, organic revenue, we're guiding to growth of 7% to 9%, and full-year organic growth of 8% to 10%. Our second quarter 23 adjusted EPS estimate is 48 to 50 cents, and we're guiding to a full-year adjusted EPS range of $1.90 to $1.96. I'll now provide additional highlights on first quarter, along with comments on our 2023 outlook, and Dan will provide more details on the financials. Regionally, on an operational basis, the U.S. grew 13% versus first quarter 22, inclusive of 140 basis point tailwind from the Bayless acquisition, with notable organic strength across all our business units. Europe, Middle East, and Africa grew 20% on an operational basis versus first quarter 22, with nearly every market growing double digits in the quarter. This strong above-market growth is driven by our diverse portfolio, new launches, and commercial execution with healthy underlying market demand. We remain excited about the year ahead and expect to continue to outpace our peers within the EMEA market. Asia-Pac grew 15% operationally versus Q1 2022, with broad-based strength across all major markets and business units. Within the quarter, we're pleased to have received Health Sciences Authority approval for FerriPulse in Singapore, expanding access of this innovative new technology to more patients. In Japan, first quarter growth is fueled by the launch of Agent drug-coated balloon, a differentiated coronary drug-coated balloon for instant re-stenosis in small vessels, with physicians pleased with ease of use and balloon deliverability. China also grew double digits in first quarter ahead of our expectations with solid procedural demand as hospitals work through COVID-delayed procedures. Our diverse portfolio in China, commercial execution, and supply chain management within the country supported the strong performance in the quarter. In February, we also closed our majority stake investment in Accotech, further expanding our presence in the market, and we continue to expect double-digit growth in China for the full year. I'll now provide some comments on our business units. Urology sales grew 16% organically. All four franchises grew double digits in the quarter, with strength in key products including Lithivue and Rezum. In the US, we received FDA clearance and initiated a limited market release for Lithivue Elite, which is a single-use flexible ureteroscope, which incorporates an innovative pressure sensing capability that will enable physicians to monitor intrarenal pressure during stone removal procedures. Endoscopy sales for the quarter grew 11% organically versus first quarter, 22, with broad-based strength across all regions and franchises. Our single-use imaging franchise grew double digits, and we're pleased to have recently launched our third-generation Exalt D with improved ergonomic design updates to improve the physician experience. In April, we closed the Apollo Endosurgery Acquisition, which furthers furthers our category leadership strategy within the important area of endoluminal surgery with differentiated technologies like OverStitch and X-TAC along with an entry into the adjacent endobariatric market. Neuromodulation sales grew 14% organically versus first quarter 22. Our pain business grew high single digits in the quarter with strong SCS performance driven by our innovative alpha portfolio with fast therapy, and our Cognita suite of digital tools supporting patient activation. Our Brain franchise grew double digits in the quarter, driven by new product launches including GuideXT, which was developed in collaboration with BrainLab. This revolutionary software provides implanting and managing clinicians the ability to model the effect of a patient's stimulation ahead of actual programming, which will improve procedural efficiency. In the quarter, peripheral interventions also grew 12% organically versus first quarter 22. Our arterial franchise grew double digits, led by a drug-eluting portfolio, establishing clear leadership in SFA drug elution, further supported by our differentiated Lubia long-length DES. Our venous franchise growth was driven by ongoing above-market performance in Varathena, And within the quarter, we launched ECOS Plus in the U.S., which provides more ultrasound power to resolve clot burden more quickly and completely. Our interventional oncology franchise grew double digits with strength across the entire portfolio. We look forward to initiating our limited market release in the second quarter for Obsidio, the first conformable embolic indication for the peripheral vasculature. Cardiology delivered another excellent quarter, with operational sales growing 17%, when organic sales growing 15 versus first quarter 22. Within cardiology, interventional cardiology therapies, sales grew 13%. Our coronary therapies franchise grew low double digits in first quarter, led by strong performance within our imaging portfolio, with particular strength in the U.S. with the ongoing launch of the Vigo2 guidance system. Our structural heart valves franchise continues to grow strong double digits, and we're pleased to have completed enrollment on our accurate IDE trial and continue to expect to launch accurate NEO2 within the U.S. in the second half of 2024. Watchman sales grew 29% organically versus first quarter 22. Demand remains very strong for Watchman Flex, and we now have treated more than 300,000 patients globally since launch. We are proud of our performance to date, and we continue to invest for the future through product innovation, solutions, and clinical evidence. Last week, the Population Health Research Institute announced the IDE approval of LAOS-4, which is a collaborative research study with Boston Scientific that will continue to expand our LAAC clinical evidence. This trial is expected to start in mid-2023. It will complement the existing Champion AF and option trials. Cardiac rhythm management sales grew 8% organically versus first quarter 22. Our diagnostics franchise grew strong double digits in the quarter with continued momentum across the portfolio. In core CRM, both our high voltage and low voltage businesses grew mid-single digits, and we believe that all major markets were in line or slightly above market growth. We do expect our core CRM growth to taper closer to market growth for the remainder of 23 as replacement tailwinds neutralize. Electrophysiology sales grew 54% operationally and 31% organically versus first quarter 22. Our international EP business grew 40%, and importantly, the EMEA region grew our EP business 57%, driven by strong adoption of FerroPulse and PolarX. We continue to invest in the expansion of our portfolio and received approval in Japan, Canada, and Europe for PolarFit, which is an expandable balloon catheter capable of creating 28 and 31-millimeter sizes, providing procedural adaptability and efficiency. And just last week, one-year outcomes data from the Manifest PF Registry were presented as a late breaker at EHRA. This is the first large, real-world data set on a novel ablation technology, which demonstrated real-world safety, efficacy, and efficiency of the FerroPulse PFA system. The data also reinforced the minimal learning curve and reproducibility of the FerriPulse workflow in everyday commercial use. We continue to advance our clinical evidence within this space and initiate enrollment in our Advantage AF trial, which is studying the use of FerriPulse for patients with persistent atrial fibrillation. We also look forward to the readout of our ADVENT-USID randomized control trial in the second half of this year and continue to expect their approval in the U.S. in 2024. We're also very pleased with the performance of our Access Solutions franchise, which grew strong double digits in first quarter, driven by further penetration into transeptal crossing procedures. Last week, we released our 22 performance report, outlining our environmental, social, and governance results. We are pleased with the progress our global teams have made to advance sustainable innovation while contributing to a healthier planet, addressing inequities and supporting communities around the world. We have much more to do, and our values-based culture will serve us well as we continue to transform lives and hold ourselves accountable to our commitments. We are confident the year ahead will bring many more exciting milestones across each of our business units, and we remain committed to our financial goals of consistently growing faster than our underlying markets and our peer group, expanding operating margins, and delivering double-digit adjusted EPS growth with strong free cash flow generation. We also look forward to hosting our Hybrid Investor Day event on September 20th. With that, I'll pass it off to Dan to provide more details on the financials. Thanks, Mike.

First quarter consolidated revenue of $3,389,000,000 represents 12% reported revenue growth versus first quarter 2022 and reflects an $88 million headwind from foreign exchange, slightly favorable to our expectations with continued volatility in foreign exchange rates throughout the quarter. Excluding this 290 basis point headwind from foreign exchange, operational revenue growth was 14.9% in the quarter. Sales from the acquisition of Bayless through mid-February contributed 90 basis points, resulting in 14% organic revenue growth, nicely exceeding our guidance range of 6% to 8%. Strong revenue performance resulted in Q1 adjusted earnings per share, of 47 cents, again, exceeding the high end of our guidance range of 42 to 44 cents and representing growth of 19.2% versus 2022. Adjusted gross margin for the quarter was 70.4%. We continue to expect full year 2023 gross margin to include a similar level of macroeconomic and supply chain headwinds as 2022 and expect a sequential improvement in Q2 resulting in a first half 2023 gross margin that is higher than the second half of 2023, largely due to the timing of foreign exchange movements in 2022. First quarter adjusted operating margin was 25.5%. We continue to prioritize operating margin expansion and are maintaining our full year 2023 goal of approximately 26.4% adjusted operating margin, representing 80 basis points of improvement versus the full year 2022. On a GAAP basis, the first quarter operating margin was 16.3%. Moving to below the line, first quarter adjusted interest and other expense totaled $78 million, slightly favorable to expectations due to gains on certain unhedged currencies. On an adjusted basis, our tax rate for the first quarter was 12.8%, including discrete tax items and the benefit from stock compensation accounting, slightly higher than expectations due to the timing of certain discrete tax items Our operational tax rate was 13.8% for the first quarter in line with our full year expectations of approximately 14%. Fully diluted weighted average shares outstanding ended at 1,446,000,000 shares in Q1. Free cash flow for the quarter was $83,000,000 with $190,000,000 from operating activities less $108,000,000 net capital expenditures. Excluding payments related to acquisitions, restructuring, and other special items, adjusted free cash flow was $229 million. We continue to aim for full year 2023 adjusted free cash flow in excess of $2.3 billion. As of March 31st, 2023, we had cash on hand of $570 million, which in accordance with accounting standards for less than wholly owned subsidiaries includes the cash balance from Acotech of approximately $140 million following the completion of our majority stake investment. As of March 31st, our leverage was two and a half times in line with our expectations. I'll now walk through guidance for Q2 and the full year 2023. We expect full year 2023 operational revenue growth to be in a range of 9% to 11%, which excludes an approximate 50 basis point headwind from foreign exchange, excluding the impact of closed acquisitions and the recently closed divestiture of our pathology business, which had approximately $24 million revenue in 2022. We expect full year 2023 organic revenue growth to be in a range of 8% to 10% versus 2022. We expect second quarter 2023 operational revenue growth to be in a range of 7.5% to 9.5% versus Q2 2022. excluding an approximate 100 basis point headwind from foreign exchange based on current rates. Excluding the contribution from closed acquisitions and divestitures, we expect second quarter 2023 organic revenue growth to be in a range of 7% to 9%. We expect our full year 2023 adjusted below the line expenses to be approximately $340 million. We continue to expect our full year 2023 operational tax rate to be approximately 14% with an adjusted tax rate of approximately 13% under current legislation and forecasted geographic mix of sales. We expect a fully diluted weighted average share count of approximately 1,458,000,000 shares for Q2 2023 and 1,464,000,000 shares for full year 2023, which includes the 23.98 million shares we expect to issue based on our current stock price on June 1st, 2023, upon the conversion of our mandatory convertible preferred stock. We expect the impact to adjusted earnings per share to be neutral with the approximately $14 million quarterly preferred stock dividend ending at the time of conversion. We expect full year adjusted earnings per share to be in a range of $1.90 to $1.96, representing 11 to 15% growth versus 2022, which we believe delivers top-tier financial performance. We continue to anticipate a neutral impact from FX on full-year 2023 adjusted earnings per share. We expect second quarter adjusted earnings per share to be in a range of $0.48 to $0.50. For more information, please check our investor relations website for Q1 2023 financial and operational highlights, which outlines more details on Q1 results and 2023 guidance. Before I turn the call over for a few upcoming events to note, we will be hosting our annual shareholder meeting on May 4th at 8 a.m. Eastern, and our Q2 2023 earnings call on Thursday, July 27th at 7.30 a.m. Eastern. With that, I'll turn it back to Lauren, who will moderate the Q&A.

Thanks, Dan. Amy, let's open it up to questions for the next 35 minutes or so. In order for us to take as many questions as possible, please try and limit yourself to one question. Jamie, please go ahead.

Ladies and gentlemen, at this time we will begin the question and answer session. To ask a question, you may press star and then one on your telephone keypad. If you are using a speakerphone, we do ask you please pick up the handset prior to pressing the keys to ensure the best sound quality. If at any time your question has been addressed and you'd like to withdraw your question, you may press star and two. Again, that is star and then one. to ask a question. Our first question today comes from Robbie Marcus from J.P. Morgan. Please go ahead with your question.

Oh, great. Good morning, and congrats on a great quarter here. Thanks, Robbie. Let me start with, and I'll just ask one two-part question here. Great, great performance in the first quarter, particularly on the top line. We all know this is probably the last easy comp from COVID trends in first quarter last year. But would love to get a sense of, you know, what are you seeing globally? How sustainable is this? You know, you guided to a slight deceleration second quarter. Anything to note there other than conservatism? And then second, you know, there have been some news reports lately about M&A on the behalf of Boston Scientific. We'd love to just get a refresh on your M&A strategy. We've seen a lot more smaller tuck-in type deals historically. You know, is that still the goal? And any thoughts there? Thanks a lot.

Sure, Ravi. Thanks for the question. The second one's easier for me. Then I'll do the first one. On the second one on MA, as you know, we've been consistent over the years. As a matter of practice, we never comment on rumors or speculation in the marketplace. On the first question, really proud of the global performance really across the board. If you look on the regional side, as I mentioned in the script there, U.S. grew 13%. I think it's really important to note that Europe grew 20%. and Asia PAC grew 15. So it wasn't one region or one business. It really was across the board performance. And it's encouraging in Europe in particular where we have an impressive product line in our EP portfolio and in our TAVI portfolio that's not launched yet in the U.S., which I think is a good signal for the future as you'll hear about more in Investor Day, as well as in Japan where we have our PolarX product approved in Japan but not approved in the U.S. So And the fact that the U.S. put up a double-digit number, albeit on some softer comps, as you said, given the COVID impact, the European and Asian pack performance is really impressive, and LATAM. And those products, many of those products are not yet approved in the U.S. So overall, really pleased. You saw, you know, most every business unit grew double digits. But I think more importantly, and not all of our competitors have reported yet, but we'd be surprised if we didn't exceed LATAM. the peer group across each one of our businesses. So the execution of the team is quite strong. And also I would say there were clearly some underlying market improvement in first quarter. You saw the public hospitals report good patient volume, particularly good outpatient volume, which is a good indicator for Boston Scientific given our portfolio. Nursing shortage is still a challenge for sure, but has improved. and, you know, hospitals being very efficient. So the underlying backdrop for procedure volume demand has improved and is strong, and our portfolio really meets the moment around the world. So we're really pleased with the overall performance.

And then specific to Q2, Ravi, just to double-click a bit on that, as Mike said, relative to CRM, you know, that grew 8% in the quarter. We had talked about at the beginning of the year that kind of growing at market, lower single digits. We have some replacement trends that start to get a little bit more challenging. So that 8% probably a bit outsized for what we're expecting there. And then Neuromod, as you look at that, that's a business that over the last many quarters has been kind of in that low single-digit range. And to pop a 14, that's great in the quarter, but I think a little early to call the ball on that market and say that it's fully recovered. So just the 7 to 9 I think is appropriately prudent for second quarter guidance.

Great. Thanks for the thoughts.

Welcome. Our next question comes from Joanne Wench from Citi. Please go ahead with your question.

Good morning, and may I reiterate or repeat the quarter? One of the things I've been trying to figure out this particular quarter is how much of what we're seeing is easy comps, pent-up demand, or something else. I know you can't particularly pick that apart on this kind of delivery, but if it is pent-up demand, is there any way to quantify how many quarters or what kind of tailwind that is And I'll throw my second question in, too. Fairpole seems to be doing quite well outside the United States, and we're getting a lot of questions on the timing of it in the United States and what that ramp may look like. If there's any color or sort of level setting of expectations, that would be appreciated. Thank you.

Sure. On the first one, Joanne, I wish we could give you a perfect scientific response to your question on the overall market. I would say It's, it's a healthy market for all the factors that you just indicated. There are some easier comps. You know, our comp for Q1 was, uh, what it was, uh, eight, nine, seven, but that was based on, you know, COVID impacted, uh, uh, 2021. So that maybe the comps are a little bit easier, but clearly the, uh, procedure volume is stronger. Uh, as I mentioned with the, the hospitals that have reported the outpatient momentum, uh, is quite strong, which fits our portfolio. And we've got a very strong portfolio cadence across the world right now. So I think it's really all those things that contribute to a very strong first quarter and the increase in the guide that we gave for the full year. You know, we typically said previously that the markets that we serve grow kind of plus 6% in that range. Clearly, the market grew faster than that in the first quarter. But we're not quite ready to call you know, this exceptionally strong market growth for the full year. We think that would be premature to do that and not responsible. So that's why we gave the guidance that we did of the 8 to 10 full year, because we do see strong underlying market demand, but it may not be quite as strong as we saw in first quarter. And we'll see as the year goes on. On FairPulse, you know, I was at that EHR meeting in Europe just last week, and the enthusiasm for FairPulse is very unique, I would say. The manifest data was excellent. And Dr. Stein is here. Can you remind us when do we expect the trial to read out?

So our USID trial, Joanne, is ADVENT. It's the most rigorous trial that anyone's done in this space. It's a double-blind, randomized trial against conventional thermal ablation. Continue to expect to present that data second half of this year. Submit to the FDA at the same time. So, again, continue to anticipate U.S. approval in 24.

Would you expect it to ramp similarly to what you're seeing outside the United States?

Sorry, I didn't hit the question.

She asked, would sales ramp similar in U.S. versus... With Ferripulse? Yeah.

Yeah, so Ferripulse, we broke out the number for you in Europe, which is 57%, I believe.

Organically, all EP.

Yep, and that includes PolarX, which makes a very strong contribution, and we expect approval for PolarX in the U.S. the second half of this year. We do expect PolarX to be a nice part of our portfolio globally for many, many years. So that's having a nice contribution, and Ferripulse is having an outweighed contribution despite some still limitations in supply. Customer demand is outpacing supply, I would say, still at this moment. Clearly, there's a lot of enthusiasm. You saw the manifest trial data in terms of the safety, the efficacy, and the productivity has clearly been differentiated. We'll continue to report our progress in EP, but the momentum in Europe is quite strong, and that's why we called that number out for you.

Thank you so much.

Our next question comes from Rick Wise from Stifel. Please go ahead with your question.

Good morning to you both, and good morning to everybody. Mike, just looking ahead to the September 20th analyst day, Boston's excellent CFO recently spoke in public, I think March 1st at my friend Joanne's event, and said that he's excited for the next chapter for the company for 23, and then for 24, five and six. And I think he said, Boston has the opportunity to have a special chapter for the company. I'm just wondering, what do you think Dan meant? What is a special chapter, and does that possibly suggest more willingness, given that everything is happening fundamentally and with the product portfolio, to commit to a sustained higher growth rate guidance for the next LRP?

Well, Dan's a smart guy, and he wouldn't have said that unless he meant it. And so I certainly support that. We'll lay it out more on Investor Day. But just – Overall, you see the strength of our businesses really across the board, and the portfolio mix continues to help us. It's what we purposely designed and executed on for many, many quarters in a row. Our businesses in the slower growth markets continue to get smaller and smaller as a percent of our sales, and we continue to layer on faster growth markets and better innovation that also help us with pricing. and you're very aware of many of our key products that are launched outside the U.S. that are not in the U.S. that we can make very nice gross margins and have high customer demand. So we look forward to bringing those to the U.S., and we'll also tell you about some other products or capabilities that may lie outside our three-year LRP. But we'll share all that at Investor Day, but we're very excited about the future of the company.

And I'm going to sneak in one quick follow-up on Ferrapulse. I know that you've been supply constrained on ferropulse generators. Is that situation improving? Will it be resolved by the time you hopefully get U.S. approval? Any update on that situation? Thank you.

Yes, we do expect that to dramatically improve prior to having U.S. approval, primarily because we have really important strategic contractors that we have very long-term contracts in place with, who are very much part of our solution. But we also in parallel have internal capabilities that we're ramping up. And so both those things will continue to happen for many, many years. But we do expect, particularly in the second half of 23, to have enhanced council supply to meet the demand. And we expect by the time the U.S. approval, that we'll have significantly more capabilities in this area. So I guess for that reason, it's the only reason why we're happy about the timeline and the slight delay in the U.S. with the trial is to ramp up production. But we expect to be able to meet that demand in the U.S. when we get approval. Thanks so much.

Our next question comes from Larry Bigelson from Wells Fargo. Please go ahead with your questions.

Good morning. Congrats on a great start to the year here, guys. So one for Dr. Stein, one for Mike. So Dr. Stein, you know, Farrapulse is a single shot technology, you know, with PFA energy, you know, but companies are developing large focal catheters and dual energy sources. How are you thinking about the evolution of Farrapulse, you know, beyond its current geometry and energy source? And Mike, you know, we all completely understand you won't comment on rumors, but, you know, there are interesting assets in medtech that would you know, push you to over four and a half times leverage or require the use of equity to relatively large deals. You know, are those options on the table? And just remind us of how you think about ROIC. Thank you.

Yeah, thanks, Larry. The second one. As a matter of practice, Larry, we don't comment on rumors of speculation. You know, I will comment on, we did comment on the closing of Apollo in the quarter. which is really going to be a nice asset for us, endoscopy, expand our endoluminal presence, and a nice continued focus on category leadership. So, yeah, we have our venture portfolio. We've signed the Aquatech or closed the Aquatech deal this year. We had closed the Apollo deal. But like we always said, any future deal speculation as a matter of practice, we don't comment on.

And then, Larry, on sort of the evolution of Ferropulse, we certainly are looking at alternative technologies. catheter form factors, and as you mentioned, there are a lot of different things that you can do with pulse field energy and with the Farrah Wave platform or the Farrah Pulse platform. I do think it's important, though, as you think through that, to think through the different use cases, and so for atrial fibrillation, whether it's paroxysmal atrial fibrillation where really the goal of therapy is just pulmonary vein isolation, or whether it's persistent atrial fibrillation, where you may very well need to go beyond that, do pulmonary vein isolation plus posterior wall isolation, which we're investigating right now in our ADVANTAGE trial. And as Mike noted in his prepared remarks, we've already begun enrollment in that trial and really are, I'd say, beyond pleased at the excitement, at the rate at which we're enrolling in that trial. When you think about both of those use cases, it's our belief, and in fact the data that you've seen from things like MANIFEST supports that belief, that the Farrow Wave catheter itself is uniquely well-suited among all the competing technologies for achieving those goals. So again, when you think about AEF ablation, we think that the Farrow Wave catheter is the best of the catheter form factors out there. And then when you couple that with the waveform that we deliver, when you couple that with the dosing protocol that we've optimized over the many years of preclinical and clinical research that Farrapulse did and that we've continued since the acquisition, we are really satisfied with that as the catheter that's going to be preferred for afib ablation. And then it's adding on to some of these other form factors that you talk about as we think about some of the smaller use cases beyond the AFib market.

All right. Thank you very much.

Our next question comes from Travis Speed from Bank of America. Please go ahead with your question.

Hey, thanks for taking the question. I guess high level, maybe you could just refresh us on your overall capital allocation priorities. and start there. And then a quick question on the guidance. Revenue growth obviously moved up quite a bit, but earnings didn't move up quite as much. So I just want to make sure I'm not missing something on the EPS side, given that margins are staying the same.

Sure, Travis. I think I can probably take both of those. Capital allocation priorities remain unchanged. It's been an equation that's worked well for us for many years here relative to capital allocation. So first priority is high-quality tuck-ins. adjacent high growth M&A. And Mike just gave you a couple examples of those that we've closed this year. And then we fill in on the back with any excess cash for share repurchase. And as you know, obviously don't pay a dividend this time. So I think that's clear. With respect to the drop through in the quarter, as I look at it, we kind of beat the midpoint of the range and the consensus by $200 million. You drop that through at our overall margin percentage, and you get to about, you know, two to three cents of additional adjusted EPS you would have expected. We delivered three and a half. I think that's kind of in that range. We're at 25.5% adjusted operating margin. I think that puts us right in place to achieve that 26.4 for the year. So I think all's well relative to the margin profile. And if the 26.4, again, it would be 80 basis points on top of – of last year, which I think gives us a bit of differentiated expansion versus our peer set.

Great. Thanks a lot.

Sure, Travis. Our next question comes from Vijay Kumar from Evercore. Please go ahead with your question.

Hey, guys. Congrats on the printing. Thanks for taking my question. I had a two-part, one product and one capital allocation. On the product side, PFA, Mike, did I hear it correctly? uh, on the prior question on, on, uh, Sarah calls, uh, can it do point by point, uh, ablation at this point? I thought it was single shot, um, uh, cancer, but I would be curious to know, uh, if you have, if it can do point by point ablation and, and, uh, are you gaining share in the RF side as well, uh, in the current market? Um, and then on, on the capital allocation side, um, I know you're not going to comment on market speculation, so this is not related to market speculation, but can you just remind us, in current interest rate environment, what kind of leverage levels would Boston be comfortable with? And if Boston deems a deal as strategic, would it be okay doing an earnings dilute appeal?

Yeah. Let me start with a question about the Farrah Pulse and Farrah Wave and really answer it in two parts. So the first part, so the current catheter that we have approved in C-mark countries and, as Mike said, in Singapore, and that we're evaluating in the U.S. in the ADVENT trial is a quote-unquote single-shot catheter. So it's not a point-by-point ablation catheter. And as I said to Larry, it's a catheter form factor that really is uniquely well-suited for pulmonary vein isolation and for posterior wall isolation. And again, we firmly believe that this is the best form factor out there for tackling the vast majority of patients who are undergoing atrial fibrillation ablation. Now, having said that, and I think sort of the proof behind that is when you look at our commercial release in Europe, we are taking share both from centers that were quote-unquote single-shot centers, so the cryo users, but also taking share from folks who were very well-known in the field for their point-by-point RF ablation. I'd say we've really been impressed and pleased at the way we're converting folks who were point-by-point users into PFA, and that's based on the safety, based on the efficacy, and also, frankly, based on the efficiency of ablation with FarrowWave.

And then relative to your specific question on leverage, I'd say it's been a focused and intentional journey for us to get back to BBB+, with all three rating agencies that rate us, and very comfortable there, obviously committed to investment grade and comfortable at that BBB rating.

Sorry, on earnings dilution, Dan, would you be concerned earnings dilutive deal if Boston deems it as strategic?

I wouldn't comment on specific dilution and this and that. I think from our perspective, relative to the M&A environment, we're committed to looking at deals that are high growth and tuck in acquisitions as we've done.

Thanks, guys.

And our next question comes from Danielle Antoloffi from UBS. Please go ahead with your question.

Thanks so much. Good morning, everyone, and congrats on a really strong quarter. Just a question on Farrah Pulse. Sorry, there's so much focus on this one product on the call, but I'm curious about how you guys are thinking about the evolution of the market broadly. I mean, this has been a market, the AF ablation market, that's been a double-digit grower for the last decade plus. But is it right to think about Farrah Pulse and just the advent of pulse field ablation overall as potentially accelerating market growth in a meaningfully and sustainable way? because of the safety profile of the device, or how are you thinking about, and what are you seeing, I guess, in Europe about market growth overall for this device? And I have one follow-up on Watchman.

Yeah, sure, Danielle. I guess I'll take that first one, and we'll see on the follow-up. I mean, the easy answer to what your question was is yes. You know, we do see TheraPulse. accelerating adoption of AF ablation. AF, right, is the most common sustained arrhythmia that's seen globally, in fact. Ablation today, for current indications, is still very much underpenetrated. It's underpenetrated for a couple of reasons, right? And one is safety concerns around the procedure. One is just the skill level and the relative inefficiency of AF ablations today using thermal energy. So I think, you know, first of all, you know, with the TheraPulse system, with TheraWave, and again, the safety, the efficacy, and the procedural efficiency, I think it's going to pull more people in who are currently indicated. And then, you know, also believe that there's a real opportunity to drive further use of this with patients with persistent atrial fibrillation, where, frankly, conventional thermal ablation results are marginal at best. It's one of the reasons we're so excited about the ADDvantage trial that we recently began enrollment in the United States, which is aimed at getting approval and indication for Farrow Wave for persistent atrial fibrillation, as well as paroxysmal atrial fibrillation.

Okay, thanks for that. And then my question on Watchman is just really around in a similar vein sort of what we're seeing from a market growth perspective there because really strong numbers, hard to parse out what's backlogged, what's underlying growth, but it's been growing quite healthily for a while with a competitor launching in the U.S. Just curious what you're seeing from a market growth acceleration perspective on Watchman. Thanks so much.

Sure. I would say we call the market growth. 25%-ish growth, so very, very strong as it continues to get more and more scale. I think it's important to note that we believe our share is maintained at least flat, if not actually increased, over the past six months. So our teams in the U.S. have done a very, very excellent job commercially with the Watchman Flex product. So we continue to see this be the plus 20%, 25% market grower. for a number of years here. And then we have these very groundbreaking trials with Option, with Champion, and we just highlighted Laos IV, which will follow those. So we're very committed to the market development of this category and expanding the indication over time through these clinical trials, assuming that they're positive. And I think just as importantly, we look to continue that momentum with our product cadence. We have a differentiated steerable sheet that'll be approved. in the coming nine months. And then our third generation Watchman product, which we'll be launching kind of around this time next year, our first quarter next year. So we've got the portfolio and the clinical work to continue to expand the market, and the team's doing an excellent job.

Thank you. Yep.

Our next question comes from Cecilia Furlong from Morgan Stanley. Please go ahead with your question.

Great. Good morning, and thanks for taking the question and also echoing my congrats on the quarter. I wanted to ask specifically just your comments on pain and SES, really what you saw in the quarter, especially as it pertains to recent headwinds prior auth, and then just your outlook in terms of underlying market growth. Did we see some recapture in one queue? Was that part of the strength in how you're thinking about underlying market growth going forward?

Sure. In the first quarter, we did see an improvement out of that global business. The overall business grew 14% led by our deep brain stimulation business. They had a terrific quarter. And spinal cord stent did fine, about 9%. So in the quarter, there definitely was some improvement in staffing, which likely helped the entire market and the neuromod business. And as we said, there are some slightly favorable comps as well in the quarter. comparing to the 21 COVID year. But overall, we expect that business and the pain size to grow above market and the brain side, DBS, significantly above market. And we're very excited about this new StimView capability. One challenge with deep brain stimulation, it's an excellent procedure, but it takes quite a bit of time and a lot of coordination between neurologists, implanting physicians, the patient, And we believe this software enhancement will continue to improve the productivity and cycle time for patients. So overall, I think it's too early to call what we think the market will be for spinal cord stem for the full year. We still would say maybe mid-single digits, kind of 5%, 6% is where we would land if you forced us to give you a number now.

Great. And if I could just quickly follow up on China, some of your comments, what you saw in the quarter, coming in ahead of expectations, how should we think about really just the rest of the 23 in terms of pent-up demand, backlog procedures, and then also what you've seen to date with Watchman in the region? And thanks for taking the questions.

Yeah, China catches up to everything quickly. So there was an impact early in the quarter with COVID procedures, and they clawed that back very quickly the second half of the quarter. So we do expect double-digit growth in China. despite some of the pricing pressure consistent with previous years, really based on the strength of the overall portfolio there, and continuing to expand our capabilities. We're excited about this ACOTEC agreement, where we own 60% of ACOTEC, which is a local China company that's the leader in drug-coated balloons in the region, as well as many other peripheral and potentially cardiology procedures. We think that Strategic Alliance will also help us and help them. And we continue to expect double-digit growth in China. And Watchmen, you know, I have the exact numbers, is doing fine in China. And, you know, we can provide more details in the future. But that flex is approved, I believe, there, isn't it? Yes.

Good quarter.

Yep.

Thanks for taking the questions.

You're welcome. Ernest. Our next question comes from Matt Taylor from Jefferies. Please go ahead with your question.

Good morning. Thanks for taking the question. So, great result. I guess what I'm struggling to understand is, you know, obviously you saw strong demand in the quarter, and I think we're seeing a lot of macro things improving, like staffing, et cetera. I mean, couldn't it actually theoretically get better sequentially? Why are we thinking so conservatively? Do you think that the direction of travel could be positive, negative, or neutral? And what are some of the background thoughts that you would base that on?

Well, I would say, again, we were super proud of the quarter. We exceeded, we believe, the peer group and did well across every region. I won't go through every one. We do think there are, despite it being a 9.7 comp, again, it's off of a lighter 21. So we do think there is some comp benefit there, despite it showing a 9.7 if you look at the number. But that doesn't take away from the excellent performance in the quarter overall as you compare to our peers. So I just think it would be not prudent for us to assume the same market growth for the remainder of the year when traditionally this has been a call it 6.5% markets that we serve in. Over time you're going to see that serve market growth continue to expand like we have every every couple years based on our portfolio So to say that the markets kind of jump from six percent to ten percent Over the last six months probably isn't feasible. So we think that the markets are healthy we still think the markets grow to kind of six to seven where we serve and Those will hopefully increase over time as our strategy continues to play out But it's too soon to call the first quarter performance for the market lapping every quarter.

Yeah, and then, Mike, just to follow up on that, I mean, thinking ahead to 2024, you know, if we do have some, let's call it supernormal growth this year, some catch-up or whatever, do you still think that you can grow in kind of the LRP range in 2024 over, you know, what could be a tough comp in 2023 if things play out well?

I would attend our investor day. We'll give you a sense then of what we think the LRP is for 24, 5, and 6. We'll see how this year plays out over the next few quarters. But I would imagine, as we have at prior investor days, we'll give you a good sense there about what we think the next three years look like.

Okay. I'll be there. Thanks, Ken.

All right.

Thanks, Matt. And our next question comes from Matt Mixick from Barclays. Please go ahead with your question.

Great. Thanks so much. So a question for Dan and then just a couple of follow-ups on some of the product lines here we haven't yet talked about so much on the call. So for Dan, pre-cash flow conversion, could you talk maybe a little bit about where you're at now, where you want to be, and what some of the challenges are currently in a supply chain or whatever else has been more challenging and how you're kind of tackling those? And as I mentioned, just have one other follow-up.

Sure. I think I would say I'm not where I want to be yet on free cash flow conversion. It's a key focus item for us. Some things are structural and some are probably a bit more transient and focused on working capital. The foundational ones are as an acquisitive company, and we're going to continue obviously over time to to be acquiring companies, we're going to have integration costs. So that's a cost that kind of gets in the way of free cash flow conversion. We have had in the past, we've had litigation challenges. I think those are waning over time here. That's a good thing. So that's one less thing that will get in the way of that. We have restructuring as well. So we have restructuring charges, I think, good hygiene of a company to continue to drive out continuous improvement and drive out unnecessary costs. So I think those are still going to be there. So from a foundational perspective, those are a bit challenging relative to the difference between operating cash flow and adjusted cash flow. On the working capital side, the things that we really focus on there relative to receivables and payables and inventory, have a real maniacal focus inside the company to continue to make those continue to be in our favor. Some things are structural relative to how the differences between operational and adjusted free cash flow. Others have our focus, but The takeaway is we are probably not where I want to be, but focused on improving that over time.

Great. Thanks. And then maybe to follow up for Mike. So interventional oncology, you know, when we talk to clinicians, that business just seems to be, you know, growing at very healthy kind of rates in these centers. So, you know, just any quick color comment on what Obsidio could mean to that business. And then, you know, similarly, you know, stone management, Very strong. Maybe if you could talk a little bit about, you know, how the Luminous acquisition is kind of dovetailing there and what the impact of this new single-use scope could be. Thanks.

Yeah, Matt, thank you, first of all, for bringing up these other businesses that are, you know, over $2 billion and growing very fast and accretive to our margin profile overall. FerroPulse we love, but sometimes it drowns out everything else we're doing as a company. Interventional Oncology is so pleased with overall that BTG acquisition. It's been integrated very well. Jeff Mervis, Peter Patz, and the team do a really nice job with that. We continue to take core share with Y90. The Cryo product that we have has been a surprise for us. It does extremely well globally. This Obsidio should be, again, another differentiated product to round out that portfolio even further. It just speaks to the category of leadership focus that we have as a company. We're very well positioned from a portfolio standpoint. The team is also pushing for new clinical indications. It's very early. They won't be impacted in the LRP, but we think Y90 and other therapies can be used outside their current indications, and we hope to prove that through our clinical science over the coming five years, so we want to invest long-term there. So we see a bright future overall for interventional oncology, and we're positioned well. And the same goes for the similar words, although be it different products, for urology. We're the clear global leader here. The team has taken LithoView, the single-use scope, and pioneered that, and really want to continue to pioneer that industry and tie in our pressure sensor, other AI algorithms, and fluid management to create a smarter, more efficient system that's more productive for the doctor and the staff and have better outcomes for patients. So we call that StoneSmart, and that's a multi-year journey that the team continues to execute well on. So I think that differentiated product as well as the other key components of that urology business make Boston really a preferred partner for most customers. We have to earn that every day with our clinical people and our smart contracting, but we have a very robust portfolio to serve that call point.

Thanks for that.

And our final question today comes from Chris Pasquale from Nefron. Please go ahead with your question.

Thanks for fitting me in. Sorry, Mike, but I'm going to go back to Ferripulse real quick here to finish up. Dr. Stein, I want to ask a couple follow-ups on the MANIFEST study. First, do you think 80% efficacy in paroxysmal patients is a realistic goal for advent, or should we keep in mind any important differences in endpoints or trial design? And then second, I was struck by the relatively low use of mapping in Europe today. How important do you think arrhythmia integration is to the long-term outlook of Ferripulse, and how are you thinking about the regulatory pathway and timing to achieve that?

Yeah, Chris, I'll take manifest first and then say a few words about where we think we need to be in terms of mapping. And so, I mean, as you guys said in the question, there are some very important differences in trial design between our Advent study and what you saw in Manifest. And, you know, some towards the positive, some towards the negative. There are differences, actual definition of endpoints. So in Manifest, that 80% number that you cite allowed for patients to still be on a previously ineffective antiarrhythmic drug over the course of the year. That would not count as a success in ADVENT. And the actual just monitoring strategy in ADVENT is a lot more intensive than it was in a registry like MANIFEST. On the other hand of that is that MANIFEST is the first broad rollout in real-world commercial experience, you know, as opposed to just going to some, you know, highly selected clinical trial sites. I think what I'd urge on ADVENT, really the importance is the comparison in the randomized trial against thermal ablation techniques. The trial right is designed as a non-inferiority trial. We would have had to design a much larger trial to be able to use superiority as a primary endpoint. although if we hit non-inferiority, we're allowed to test for superiority. But really, the goal in ADVENT is, again, to get regulatory approval based on non-inferiority versus thermal techniques. And then let's look, and in real-world use, let's see if we can duplicate results like the manifest results in the United States. On mapping, I think we... anticipate in the United States we'll see more use of mapping than we see in Europe for the obvious economic reasons. You know, having said that, right, for paroxysmal AFib, where you're just doing pulmonary vein isolation, you know, it's pretty clear that you don't have to map to have a successful procedure with TheraPulse, and the manifest results speak for themselves in that regard. And I'd expect things to split out, you know, pretty much the same way they do with cryoablation. When you go beyond that, though, I think there will be more of a tendency to want to map those cases. And so, you know, we will have a second-generation farrow wave catheter that will be integrated with the Rhythmia system, but we're never going to force people to use Rhythmia. We're always going to maintain it as an open system. You can map with whatever system you want, although we believe with some of the enhancements we're going to bring out, It's going to drive a lot of folks to want to use Rhythmia when they want to map a fair wave case.

Thank you, Dr. Stein, and thank you for joining us today. We appreciate your interest in Boston Scientific. If we are unable to get to your question or if you have any follow-ups, please don't hesitate to reach out to the Investor Relations team. Before you disconnect, Jamie will give you all of the pertinent details for the replay.

And ladies and gentlemen, that will conclude today's conference call and presentation. To join the replay, we will have it up within the next two hours. The conference ID would be 274-2311. Again, that is 274-2311. The dial-in numbers would be 81877-344-7529 or 1-412-317-0088. The replay will be available until May 3rd, 2023 at 1159 p.m. Eastern Time. Once again, today's conference is concluded. Thank you for attending. You may now disconnect.