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spk15: We all need a little love what you do.
spk00: Yeah.
spk06: Good morning and welcome to the Boston Scientific second quarter 2022 earnings call All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Lauren Tingler. Vice President, Investor Relations. Please go ahead.
spk12: Thank you, Andrew. 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 Q2 2022 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 filing. The duration of this morning's call will be approximately one hour. Mike will focus his comments on Q2 performance, as well as future catalysts and the outlook for our business, including Q3 2022 and full year 2022 guidance. Dan will review the financials for the quarter, provide more details regarding our Q3 and full year 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 growth further excludes acquisitions and divestitures for which there are less than a full period of comparable net sales. Relevant acquisitions excluded for the organic growth are Preventus, Faripulse, and Lumina Surgical, which closed in March, August, and September of 2021, respectively, as well as Bayless Medical, which closed on February 14, 2022. Divestitures include the BTG Specialty Pharmaceuticals, which closed on March 1, 2021. Guidance excludes the recently announced agreement to purchase the majority stake of MITEC, which is expected to close in the second half of 2022. For more information, please refer to our Financial and Operatings 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 federal security flaws, which may be identified by words like anticipate, expect, may, believe, estimate, and other similar words. They include, among other things, the impact of COVID-19 pandemic upon the company's operations and financial results, statements about our growth and market share, new and anticipated product approvals and launches, acquisitions, clinical trials, cost savings, and growth opportunities, our cash flow and expected use, our financial performance, including sales margins and earnings, as well as our tax rates, R&D spend, and other expenses. Factors that may cause such differences include those described in the risk factor section of our most recent 10-K and subsequent 10-Qs filed with the SEC. These statements speak only as of today's date, and we disclaim any intention or obligation to update them. At this point, I'll turn it over to Mike for his comments.
spk18: Thanks, Lauren. Thank you to everyone for joining us today. We're very pleased with our second quarter performance and our strong outlook for the full year, supported by our innovative portfolio, commercial execution, clinical evidence, and strategic tuck-in M&A. In second quarter 22, total company operational sales grew 10% versus prior year, while organic sales grew 7% despite a strong comp of 9% organic growth in second quarter 21 versus 2019. Our sales results exceeded the high end of our guidance range of 3% to 6%. Importantly, we continue to grow faster than our peers in most of our businesses and regions. Second quarter adjusted EPS of 44 cents grew 9.6% versus prior year, again, exceeding the guidance range of 41 to 43 cents. Second quarter adjusted operating margin was 25.2%, which is in line with expectations. We anticipate more durable and consistent procedural growth for remainder of the year as hospitals continue to manage through staffing challenges and COVID waves. Our first half revenue performance was 8.1%, and we anticipate growth to accelerate in the second half. And therefore, we are increasing our full year 22 guidance for operational growth from 10.5% to 11.5%. and organic growth to plus 8% to 9%. For third quarter 22 revenue, we're guiding to operational growth of 10% to 12% and organic growth of 8% to 10%. We aim to improve operating margins in 2022. However, with the ongoing impact of supply chain challenges, we are updating our adjusted operating margin to 26% to 26.2% for the full year as a result of FX volatility and additional supply chain related operating margin pressure. We are narrowing our full year 22 adjusted EPS guidance to $1.74 to $1.77. Our third quarter 22 adjusted EPS estimate is 43 to 45 cents. And Dan will provide more details on both of these sales and EPS performance and the outlook. I'll now provide some additional highlights in the quarter along with comments on our 22 outlook. Regionally, the U.S. delivered operational growth of 7% versus prior year. And sales in the quarter included a transient impact from the contrast dye shortage, primarily impacting our coronary therapies, watchmen, and PI business. In Europe, Middle East, Africa, our business grew 12% in operational basis first prior year. We had excellent broad-based growth across the EMEA region with five of eight business units posting double-digit growth. Key products in emerging markets within the region are driving growth across the portfolio. with particular strength in electrophysiology, Watchman, and interventional cardiology therapies. In Asia, we grew 11% operationally versus prior year. We're quite pleased with the overall performance of the region, despite the impact of COVID and related public health measures within China, with notable performance in Japan, India, and our ASEAN countries. We continue to make progress in new products and commence the first Watchman Flex cases in China, Korea, Singapore, and Malaysia. The China team executed well in a very tough environment, growing 9% and performing in line with our expectations. We remain confident in the team's ability to drive double-digit growth for the full year 22, supported by our diversified portfolio and commercial execution. Latin America grew 33% operationally versus prior year, and all eight business units in the vast majority of countries grew double digits in the quarter. Urology and public health organic sales grew 7% and 16% on an operational basis first prior year. Globalization continues to be a focus, with 44% growth within emerging markets, driven by new and ongoing product launches such as Lithiview and Spacor in key countries, with momentum continuing with the recent approval of the TriaFirm ureteral stent in China. We continue to be pleased with the luminous integration and execution of the global Turning to endoscopy, sales grew 6% organically versus prior year. Broadly, this diverse business continues to perform well with products like our innovative Axio stent, the only stent indicated for transgastric and transduodenal access. We also continue to strengthen our single-use imaging franchise with ExaltD expanding to new accounts and driving utilization. To further broaden our portfolio, we announced an agreement to purchase a majority stake in MITech, which includes the novel Hanaro Stent Technology, a family of conformable, self-expanding metal stents. This agreement is expected to close in the second half of 2022. In neuromodulation, organic revenue declined 1% versus prior year against a very challenging year-over-year comp, with the US launches of WaveRider Alpha and Versace Genus, along with COVID procedural recovery in second quarter 21. In pain, sales grew sequentially in second quarter, with physicians excited about a robust and innovative portfolio of offerings for SCS, including Waverider Alpha, Fast Therapy, and the Cognita Practice Optimization suite of solutions. In Brain, performance also improved sequentially with the U.S. launch of the neural navigator software with StimView XT, which is our integrated imaging and programming platform, developed in partnership with BrainLab. In cardiology, organic sales grew 8% versus prior year, and operational sales grew 12%. Within cardiology, interventional cardiology therapies, organic sales grew 6% versus prior year. Our coronary therapies franchise grew mid-single digits, led by double-digit growth within our imaging business, as our Vigo2 guidance system moved into full launch in the U.S. Internationally, strong growth continues, driven by our innovative and comprehensive portfolio for imaging, preparing and treating complex coronary disease. Physician enthusiasm for accurate NEO2 continues, supported by ongoing clinical data that further validates the differentiating enhancements of NEO2, including the Italian NEO registry, which demonstrated reduced rates of PVL, low PPI, excellent hemodynamics, and high device success rate in more than 900 patients. Turning to Watchman, organic sales grew 17% versus prior year. Growth accelerated sequentially on a comp-adjusted basis with strength across the region with a full launch of Flex in Japan, market share gains in Europe, and increased penetration in the U.S. as we continue to drive awareness with ongoing clinical evidence in our second-generation device. We remain confident based on our ongoing discussions with FDA that our DAP submission will be approved in the coming months. And the usage of DAPT with FLEX was recently highlighted in real-world data with more than 17,000 patients with the NCDR registry. This demonstrated no significant difference in rates of major events at 45 days post-implant, whether patients were discharged from the hospital on DAPT, the DOAC and aspirin, or warfarin and aspirin. In rhythm management, organic sales grew 7% versus prior year. In core CRM, we anticipate that our growth was at or above the market with our low-voltage business growing mid-single digits and our high-voltage business growing low-single digits. Our SICD franchise continues to form well, further supported by positive data from the investigator-sponsored ATLAS trial presented at HRS earlier this year. The ATLAS trial compared emblem SICD to single-chamber transvenous ICD devices and demonstrated similar protection from sudden death, and superiority from serious lead-related complications at six months. Our diagnostics business continues to perform well outpacing the market driven by the Preventus portfolio and our implantable cardiac LUX DX. In electrophysiology, sales grew 9% on an organic basis and 67% on an operational basis first prior year. Second quarter performance was led by strength and differentiation of our portfolio in Europe and Japan. We're pleased to have completed an enrollment in both the Newton AF trial and the ADMINT trial. Important steps to expand the offering of our stable point for sensing catheter in the U.S. in 2023 and FerroPulse in the U.S. in 2024. Physician enthusiasm is very strong for both our Polarex and FerroPulse platforms in Europe, and we're looking forward to increasing our account openings in the second half of this year. The Bayless team continues to execute well with strong performance in the quarter led by VersaCross RF access system. The integration is on track and we're excited to have launched the Bayless developed VersaCross Connect LAAC solution to provide safe and more efficient access to left side heart for Watchman Flex implants. In peripheral interventions, organic sales grew 6% versus prior year. Within the arterial franchise, we had another very strong quarter of double digit growth in the drug looting portfolio as Ranger and Alluvia solidify their positions in key global markets. In Venus, the U.S. clot management business was impacted in the quarter by both the transient impact of the contrast shortage as well as by competition, largely offset by strength in Varathena sales as we continue to expand market share with our innovative offering. Interventional oncology grew low double digits in the quarter, fueled by our innovative cancer therapies TheraSphere and IceFX, as well as the robust set of embolization access and delivery tools that we offer. Globalization remains a significant opportunity in this space, and notably we have commenced treatment of patients with hepatic malignancies in the Hainan Province of China with TheraSphere through a medical pilot program. Outside of the Hainan Province, TheraSphere treatment in China is restricted to the Mandarin clinical trial. Earlier this quarter, we issued our annual performance report, which showcases our commitment to corporate responsibility and progress toward our longer-term goals. In this report, we highlight key metrics in support of our efforts, including performance against our first human capital scorecard, which tracks company-wide goals and is part of the company's annual bonus plan. You can access this report at any time through our investor relations website. We're very pleased with our first half results and now look for 2022 and beyond. despite the macroeconomic challenges we continue to face. Our innovative portfolio category leadership strategy, commercial execution, and commitment to ongoing clinical evidence positions us well today and into the future. We look forward to hosting an investor event at TCT this September. We'll provide more details as they're available. While the macroeconomic environment continues to be challenging, we remain committed to our long-term financial goals, continuing to grow sales faster than underlying markets, operating margin expansion, double-digit adjusted EPS growth, and strong adjusted free cash flow. I remain very grateful to our employees for their winning spirit and will now turn things over to Dan to review our financial performance in more detail.
spk16: Thanks, Mike. Second quarter consolidated revenue of $3,244,000,000 represents 5.4% reported revenue growth versus second quarter 2021 and reflects a $130,000,000 headwind from foreign exchange, higher than our expectations due to the strengthened U.S. dollar. Excluding this 420 basis point headwind from foreign exchange, operational revenue growth was 9.6% in the quarter. Quarterly sales from the acquisitions of Ferropulse, Luminous, and Bayless contributed 300 basis points, resulting in 6.6% organic revenue growth, exceeding the high end of our guidance range of 3% to 6% growth versus 2021. Strong top line results primarily drove Q2 adjusted earnings per share of 44 cents, representing 9.6% growth versus 2021 and exceeding the high end of our guidance range of 41 to 43 cents. Adjusted gross margin for the second quarter was 70.4%, in line with our expectations. Although we've seen some stabilization in the cost of freight, we do anticipate incremental second half headwinds of approximately $75 million versus pre-COVID levels, resulting from inefficiencies in our manufacturing plants due to the availability of direct materials and the cost to procure them. This incremental $75 million brings the total headwind versus 2019 to $375 million. Recall, this headwind is primarily driven by inflationary pressures on direct materials, freight, and labor costs, as well as inefficiencies in our manufacturing plants due to material availability. We now expect our full year adjusted gross margin to be slightly below the second half of 2021 adjusted gross margin of 70.8%. We anticipate a slight improvement to adjusted gross margin in the second half due to the full realization of standard cost improvements consistent with historical trends, as well as an FX tailwind from the stronger U.S. dollar. Second quarter adjusted operating margin was 25.2%, resulting in a first half adjusted operating margin of 25.5%. As a result of the increased macroeconomic pressures on gross margin, We now anticipate our full year adjusted operating margin to be within a range of 26 to 26.2%. Despite these macroeconomic headwinds, we're focused on margin improvement versus the second half 2021 average of 25.9%, with our range representing 10 to 30 basis points of operating margin expansion. On a gap basis, second quarter operating margin was 13%, including a charge related to ongoing IP litigation. Moving to below the line, adjusted interest and other expense totaled $74 million in the quarter, lower than our expectations, driven in part by a one-time FX gains from certain unhedged currencies. Our tax rate for the second quarter was 12.8% on an adjusted basis, including discrete tax items and the benefit from stock compensation accounting. Excluding these items, our operational tax rate was 14.3% in line with our expectations. We ended Q2 with $1,438,000,000 fully diluted weighted average shares outstanding. Adjusted free cash flow for the quarter was $593,000,000 and free cash flow $204,000,000 with $307,000,000 from operating activities less $103,000,000 net capital expenditures. For full year 2021 adjusted free cash flow we continue to aim to be at or above 2021 adjusted free cash flow of $2.2 billion. As of June 30, 2022, we had cash on hand of $276 million, and we continue to expect to close the purchase of the majority stake of MITech in the second half of 2022, funded with cash on hand. Our top priority for capital allocation remains high-quality tuck-in M&A, and we'll continue to assess opportunities in conjunction with our financial goals. We continue to expect leverage of two and a half times by year end 2022. And as of June 30th, our leverage was 2.6 times. I'll now walk through guidance for Q3 and for the full year 2022. We expect full year 2022 operational revenue growth to be in a range of 10.5% to 11.5% versus 2021, which excludes an approximate 400 basis point headwind from foreign exchange based on current rates. 200 basis points higher than our previous expectations and includes a 250 basis point contribution from the acquisitions of Preventus, TheraPulse, Luminous, and Bayless, and $13 million of pre-investiture specialty pharmaceutical sales in 2021. As a result of our strong Q2 performance and confidence in durable and consistent procedural growth, we are raising our full year 2022 organic revenue growth range to 8% to 9% versus 2021, excluding the impact of closed acquisitions and divestitures. We expect third quarter 2022 operational revenue growth to be in a range of 10% to 12% versus 2021, which excludes an approximate 400 basis point headwind from foreign exchange based on current rates, and includes a 200 basis point contribution from the acquisitions of Ferropulse, Luminous, and Bayless, excluding the impact of closed acquisitions We expect third quarter 2022 organic revenue growth to be in a range of 8% to 10%. We now expect our full year 2022 adjusted below-the-line expenses to be approximately $350 million, reflecting the FX gain recognized in Q2. We continue to expect our full year 2022 operational tax rate to be 14%, with an adjusted tax rate of approximately 13%. including the benefit of the accounting standard for stock compensation and discrete tax items recognized in the first half of the year. As a reminder, our tax rate reflects current legislation, including a provision on the treatment of R&D expenditures. We continue to believe there is bipartisan support to reverse this provision, and if such legislation were to be enacted, we would expect our full-year tax rate to revert to its historic range of approximately 11% operational and 10% adjusted resulting in a $0.06 earnings per share benefit. We expect a fully diluted weighted average share count of approximately 1,442,000,000 shares for Q3 and 1,441,000,000 shares for the full year 2022. As a result of continued uncertainty within the macroeconomic environment, as well as FX volatility, we are narrowing our full year adjusted earnings per share range to $1.74 to $1.77. and for the third quarter, expect to be in a range of 43 cents to 45 cents. Please check our investor relations website for Q2 2022 financial and operational highlights, which outlines more detailed Q2 results. In closing, I am proud of the first half results we achieved with projected second half momentum supporting our organic revenue guidance increase of 100 basis points at the midpoint. Despite a challenging macroeconomic environment, we remain focused on operating margin expansion and expect to see sequential improvement in the second half of this year. And with that, I'll turn it back to Lauren who will moderate the Q&A.
spk12: Thanks, Dan. Andrew, 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 limit yourself to one question. Andrew, please go ahead.
spk06: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please limit yourself, excuse please, to pick up your handset before pressing the keys. If at any time your question has been addressed and you'd like to withdraw your question, please press star and two. And as Ms. Tangler had said, please limit yourself to one question. At this time, we will pause momentarily to assemble our roster. The first question comes from Joanne Lynch with Citi. Please go ahead.
spk13: Good morning, and thank you for taking the question. May I say congratulations? I want to spend just a little bit of time on the organic growth rate, because when you entered the year, we were looking for 6% to 8%, which was raised on the first quarter call to 6.5% to 8.5%, and now to 8% to 9% organic. What is happening in your core businesses or in your particular franchises, maybe, that's helping you sort of buck the trend and actually be raising your organic growth rate each quarter?
spk18: Good morning, Joanne and Dan. Dan can supplement as well. Just as Dan mentioned in the script and I did, I would just overall we're very pleased with the execution of our global team. We had just tremendous growth in each region. Europe with a pretty mature market, as you saw, grew double digits and we made significant investments in the GEM region over the last few years and the team there has really done a nice job of building up our scale. that's driving outside growth for us in Europe, and we're taking share in the mature markets. In Asia-Pac, we've seen a rebound of strength in Japan, given the portfolio that we have, led by Polarex, which is our cryo-offering NDP, as well as Watchman. And the China team did a really nice job of delivering in a tough environment. In the US, we continue to do quite well as well, and you'll see the impact of those acquisitions going more organic, a bit benefit in the second half of the year and also in 2023. So I think the team has executed quite well. We think we've gained share in most all of our businesses, as I said in the script. And we continue to try to position ourselves into faster growth markets consistently quarter over quarter. So I'm just I think it's portfolio, the clinical evidence we're driving, and very strong commercial execution.
spk06: The next question. Oh, go ahead.
spk13: No, that's fine. Go on.
spk06: Thank you. Thank you. The next question comes from Robbie Marcus of J.P. Morgan. Please go ahead.
spk14: Oh, great. Thanks for taking the question. I'll add my congratulations on a good quarter. Thanks, Robbie. Dan, I was wondering, it sounds like you're absorbing about 300 basis points of headwinds versus 2019, but on track to generate flat operating margins, which is really impressive given all the headwinds. Maybe just walk through where you're seeing those pressures and you know, how you're offsetting it in the base business. And then if there's anything we should be focused on that carries over into 2023 in the models from some of these offsets or pressures. Thanks.
spk16: Sure. Thanks, Robbie. And maybe helpful to just give a couple of finer points on the numbers. So in 2019, we were 26.1% adjusted operating margin. We were 72.4% gross margin. So if you just look at the bottom line operating margin, the midpoint of our guidance in 2022 is back at that 26.1%. And as you said, we're absorbing the $375 million headwind, the majority of which hits in 2022. The sum of that that will go to 23 for your question of 2023. So there's some from a gross margin standpoint that will still be on the balance sheet in 23. But the majority of that 375 will hit in 2022 and hits gross margins. So when you look at the P&L, all line items of the P&L, we've had activities in place to offset that over the last two-plus years, whether it's looking at standard cost value improvement programs, pricing discipline, a bit of a favorable product mix, other opportunities to leverage SG&A and R&D in a smart and thoughtful way. And so the entire 375 has been offset through the whole P&L. You see gross margin. Obviously, gross margin is lower. We talked about being a little bit lower than last year's second half average of that 70.8%. So we haven't been able to offset the full 375 in gross margin, but that's what the rest of the P&L is for, right? Whether it's SG&A, R&D, even areas like royalties, we were very focused to offset that. So I'm very pleased to look at a 26.1% midpoint guidance for this year against that 2019 and look forward to 23 and beyond. A little early to get specific about 23, obviously, relative to what we see. We've been clear that we don't see the macroeconomic headwinds abating in 22, but we are hopeful for 23 and beyond that we'll see some relief there. Great. Appreciate the thoughts.
spk06: The next question comes from Larry Diegelson with Wells Fargo. Please go ahead.
spk05: Good morning. Thanks for taking the questions and congrats on a nice quarter. You know, I heard you mention that you are having an analyst meeting at TCT. So, are you expecting to present any significant data there? So, for example, the Saval, you know, BTK data. And if so, kind of what should we be looking for in your confidence you can overcome, you know, the issues of previous devices? And just maybe on Devoro, any color on the launch there and how you see that fitting into the treatment armamentarium. Thanks for taking the question.
spk18: Thanks, Larry. I'll make a couple comments on Devoro and maybe Dr. Meredith can answer what's heading up at TCT. Again, the broad-based PI business, you saw the performance in my report, three franchises, Our arterial franchise, which grew double digit, very strong. Our second biggest one, interventional oncology, again, grew double digit with really terrific performance and new clinical indications we're going after. And our smaller businesses, our venous business, and the gap that we have, as you mentioned, is the Devorah product that we acquired. And so we'll be in our first patients in the second half of this year, and hopefully those will go quite well. And we'll hopefully have some approval in 2023 to launch Devoro in 2023. So all things going well. You'll see some impact, you know, as the year progresses in 2023 to fill that portfolio gap that we have in Venus. So more to come, and we'll have good clinical data by year end. Ian, or Dr. Meredith, are you on the line?
spk09: I am, Mike. Thank you. Yes, sir. So the formal announcements for what's going to be presented at TCT haven't come out yet, so I don't want to comment on that further, but we're absolutely delighted that TCT will be in Boston this year, giving us a great opportunity to highlight the full strength of our cardiovascular businesses. But no formal announcement yet, as the program hasn't been finalised. Thank you. Thanks.
spk06: The next question comes from Vijay Kumar with Evercore. Please go ahead.
spk10: Hey, guys. Congrats on the print share, and thanks for taking my question. I have a two-part question. One, just on the guidance here, first half versus second half, the high end implies, I think, low doubles in the second half versus 8% in first half. You know, the pre-pandemic comps, you know, first half, second half, 21 versus 19, they seem comparable. There was no first half versus second half. So I'm curious, what's driving the second half acceleration? You know, what was the China lockdown and contrast media impact in 2Q? Perhaps is that what's giving you the confidence looking at the underlying trends for second half? And then on the gross margin, $375 million of cost, do you know what – What dollar amount of that is capitalized on the balance sheet? Thank you.
spk16: So the cost on the balance sheet, I'll take that one first. Yes, I do know what it is. And it'd be a minimal headwind for early 2023 because, as I said, the 375 that is incremental this year is not all going to hit the P&L this year, but the lion's share of it does hit in 22. So small headwind for 23, but hopefully should be manageable. Relative to your question, let me just put a finer point on the numbers, and I can turn it to Mike for some of the color. So our first half actual in 2022 in terms of our organic revenue growth rate was 8.1%. If I take the midpoint of the full year guidance, so 8.5%, that implies around 9% for the second half. So a nice acceleration to your point to that 9%. The comps, again, 21 versus 20, those are a little bit crazy comps, obviously, with the COVID pandemic. comps. So the 21 versus 19 I think is a good basis to use for comps. That's what we did all last year. The first half comp was 5.9%. The second half comp is 5.4%. So basically the second half comp is 50 basis points easier, but our revenue at the midpoint is call it 90 basis points of acceleration. So it's outstripping the comps and it's real apples to apples acceleration first half to second half, which is great to see. I'll take the China piece. And just say that relative to what we had for expectations in Q2, China was basically in line with that. The scenario that we put in for guidance, that's pretty much what transpired as part of China. Looking forward to seeing the second half return to more normal growth rates and double digits for the full year.
spk18: I don't know, Mike, if you'd add anything relative to that. We do have about a 50 basis point easier comp, second half versus first half. So that helps a little bit. In the first half, as you know, we did have some impact from the contract shortage, so that's been essentially resolved, so we think we'll see smoother sailing there. We had a tougher second quarter despite the 9% growth in China, and we expect that business to strengthen despite being quite strong in the first half. We continue to be excited about our EP business. The growth in Japan and in Europe is tremendous. and we expect to open up more accounts with Ferropulse and Cryo in those markets. I won't go through a long list. Neuromod had a super difficult comp in the second quarter, so we expect double-digit growth out of Neuromod in the second half. So we just really have strong performance across the board in our business units, slightly easier comp but not significant, and good momentum as a company on the top line.
spk10: Helpful commentary. Congrats again, Mike.
spk18: Thank you.
spk06: The next question comes from Rick Wise with CIFOL. Please go ahead.
spk03: Good morning, Mike. Hi, Dan. Maybe you could give us a little more color on two key products, both Watchman and Faribault. Watchman, you did face a difficult 2Q comp, another excellent quarter. Maybe talk about where we are in the flex rollout and what's driving that growth and how sustainable you see it or what sustains this kind of impressive growth going ahead. And on FerriPulse, we recently checked in with some early FerriPulse adopters in Europe, and they love the technology, but were concerned about price and sort of limiting their utilization. So maybe you can sort of Talk about that, how you're addressing that issue, and any color on where you are with the number of accounts and your goals in terms of account opening in Europe. Any extra color would be great. Thank you so much.
spk18: Thanks, Rick. On Watchman, Dr. Stein can further comment. Really similar comments to previous quarters. It always starts with, do you get excellent clinical outcomes? And that's what WatchmanFlex continues to prove with the safety profile and ease of use, which drives increasing comfort level from physicians and referring physicians and increasing utilization and more doctors using it per site. So really it's those clinical outcomes and the safety profile and ease of use And then in terms of the market, as you know, we're very under-penetrated still, about 8% or so in the market that we see likely around $2 billion in the coming years here. And as you know, we're doing those clinical trials with Champion and Option, which have enrolled, not completed enrollment, but are enrolling far ahead of schedule. So we think this market can continue to grow 25%, 30% for multiple years. And importantly, we have a really nice cadence of additional platforms coming for Watchman to continue to improve it. And that Bayless acquisition, we're going to make a safe procedure even more productive in terms of turnaround time with the integration of the Bayless platform with Watchman. to help improve productivity further to drive more procedure volume and utilization. And you're also getting some global expansion in Japan and China that launched their first Watchman Flex cases. Dr. Stein, any other comments on Watchman? No, not much.
spk02: Again, it's safety and ease of use with Flex. It's continued growth into the currently indicated patient populations. It's looking forward to the data, so our option trial completed enrollment and actually enrolled way ahead of schedule in spite of the COVID challenges, looking for data from Champion. And then I just want to read out what Mike said, really excited about Bayless bringing the VersaCross solution. So we've commenced that launch in the US. And again, it's just part of this whole portfolio around all of our AF therapies to make procedures safer, make them more efficient. And I do think that that's what you see driving all the growth.
spk18: Yeah, in Ferro Pulse, we're not going to provide some of the information you're asking about how many accounts, how many account openings, all those things. We obviously track that. It's a super important platform for us, we think, for many years here. And I would say overall, we've had some supply chain issues that we continue to manage, which has tampered a bit of the new account openings. Nevertheless, the team is opened up many more accounts in second quarter than in first quarter. We expect quite a few more incremental new account openings in third quarter versus second quarter. So we're increasing the pace of our account openings. The utilization of the platform is quite high for physicians. It is priced at a bit of a premium because it's a premium product. And we think that's the right appropriate pricing. And that's something that we can always take a look at for the future but we think it delivers a unique value. And it's not massively available in terms of some of the supply chain constraints. So it's important for us to continue to improve on that, which we will in the second half of the year.
spk03: Thanks so much.
spk18: Dr. Stein, any other comments there? Okay. Thank you, Rick.
spk06: Thank you. The next question comes from Cecilia Furlong with Morgan Stanley. Please go ahead.
spk01: Great. Good morning, and thank you for taking the question. I wanted to ask on Watchmen, but specifically contrast supply, if you could just talk to the headwind that posed in the quarter. And then, Bradley, too, can you speak to what you've seen from a residual staffing shortage impact across the hospital system at this point? Where do you feel we are in recovery, and how much further recovery is incorporated in your outlook for the back half of the year? And thank you for taking the question.
spk18: Sure. There certainly was an impact with the contrast shortage with Watchmen, some of our interventional cardiology procedures, and some of our peripheral procedures in second quarter. So potentially sales could have been a bit better absent that, but we haven't quantified that, and it's a bit difficult. We did see kind of mid-quarter some Watchmen procedures that were deferred due to the contrast shortage. Hopefully that helps us a bit more in third quarter. and second half to make up for some of that, but we aren't able to quantify that for you in terms of what the incremental impact was, but there was some impact in 2Q with Watchman. On the staffing shortage, hospitals do heroic work in continuing to support their communities, and it's still a big issue. And so is it better, maybe incrementally slightly better? But it's still a challenge for hospitals and thus things like procedural productivity and doing a watch procedure same day in less time and doing a Farrah Pulse procedure in Europe significantly faster with great results becomes more and more important. And I think that's the focus of our portfolio is driving great clinical outcomes but also assisting the productivity and throughput of the hospital and the patient satisfaction. I think many of our key products do that. And so the staffing shortage will continue to be with us. It's not going to be an overnight fix. And hopefully over time it continues to improve. But a staffing shortage rebound is not baked into our second half guidance. We assume that the staffing shortage will be with us for a while.
spk01: Great. Thank you for taking the questions and congrats on the quarter.
spk07: thank you the next question comes from travis steed with bank of america please go ahead hey good morning congrats on a good quarter uh so you talked about the gross margin pressures being offset in the p l just curious how sustainable that is as you move into 23 does some of that opex have to come back or can you keep opex this level until the gross margin pressures ease and then a quick follow-up on on china up nine percent much better than your peers which are still down Just curious what's driving the strength in your China business versus peers? Thank you.
spk16: Sure, I can take the gross margin and Mike can take the China. I think the management of the overall P&L is how I would answer that. So we look, as we said to Robbie's question, we've effectively been able to offset the $375 million headwind from 2019 at the midpoint of our adjusted operating margin guidance for this year. And it really is managing all lines of the P&L. Through the rest of 22 and into 23, we're going to monitor the macroeconomic situation, all the elements that we talked about. We'll see if that means we need to continue to focus on the spending that we have in place or whether we can let a little air out of the balloon on some of those items and invest some more. But key point being that all the decisions that we make relative to spending are with a long-term revenue growth pipeline in mind. We try not to make decisions that are impacting long-term revenue growth. So we look at areas that don't have an impact there. But that's what we do. We manage the P&L top to bottom, and we'll continue to do that through the rest of 22 and 23 and beyond.
spk18: China grew about 9% in the quarter, which is quite a bit less than what they typically grow. So there was an impact for sure in the quarter on the lockdowns. We saw mid-quarter very, very weak growth. And then maybe the last three, four weeks of the quarter improvements. And then we anticipate a more consistent, strong performance in the second half. You know, it's difficult to point to one thing because like Boston Scientific across the board, their portfolio is much more diversified. And the business that continues to really drive there is our complex coronary capabilities with our imaging, our Wolverine, our cutting balloon, all things related to treating complex coronary disease, which is so significant in China. And then our peripheral interventions business is also one of our larger businesses there. And so it's a diverse portfolio that obviously hits a lot of patient demand. And we have a strong team there. And they were impacted by the lockdowns quite a bit, but did a great job in improving results the very end of the second quarter, I would say.
spk07: That's helpful. Thank you.
spk06: The next question comes from Pito Chickering with Deutsche Bank. Please go ahead.
spk17: Hey, good morning, guys. Thanks for taking my questions here. Two quickies. From a capital allocation perspective, I understand M&A will always be a priority for you guys. But as you look at your free cash flow generation, what are the reasons to not get more aggressive with ShareRepo to keep driving EPS growth? And also, can you give us any details on the Vortex hard pump, such as the size of the pump, or when you start seeing data from that? Thanks so much.
spk16: Sure, Peter. I can take the Sherry purchase one. Yeah, our capital allocation strategy, I think, is crystal clear. With the available free cash flow we have, high quality, high growth tuck-in M&A is the first priority. And we use excess cash to fill in on the back for Sherry purchase. If you look over the history of the last few years, we've done a lot of great deals. I'm super proud of the class of 2021, the five deals we did there. So that utilized the available cash that we had and didn't leave any any room for Sherry purchase. So it's M&A first, and then if room with excess cash, Sherry purchase. And it's been clear, and I think it would continue to be that going forward.
spk09: That's like the Vitalist. Do you want me to take that?
spk18: Yeah, go ahead.
spk09: Yeah, thanks. So just with respect to Vortex, the product is called Vitalist, and it is an internally developed product. acute mechanical support device. We've just undertaken a first-in-human study. It's a very early phase yet, and there's not really much more to actually report at this stage. I'm very pleased with the progress in a first-in-human study.
spk17: Any chance you could give us the size of the pump?
spk18: Yeah, this is Mike. Yeah, it's just too early. Yeah, I think I'll just comment. Dr. Meredith, we completed the early feasibility study. We're very bullish on the platform. We're going to continue to drive clinical evidence that we need, but it's far too early to be sharing details about the platform. Great. Thanks so much.
spk06: The next question comes from Josh Jennings with Cowan. Please go ahead.
spk04: Hi, good morning. Thanks for taking the questions. Just wanted to focus on Watchman. And just with the DAPT label update, do you expect that to cause any change in terms of physician decision-making on device selection? I mean, it seems like it's not impacting growth and that there's some off-label utilization going on out there already with data that's been put in the public domain. And then just the second part is, I heard you say on kind of next-generation Watchman devices and saw a presentation recently about coding enhancements that could increase hemocompatibility, potentially reduce the device-weighted thrombus rate. It seems like there's some bench and animal data out there already, but any update you can give us on this coding enhancement project internally would be great to hear. Thanks for taking the questions.
spk02: Yes, it's Ken. Thanks, Josh. Let me take first just the question about DAPT again. You know, I'm probably pretty sure you're referring to data we presented at TCT from the DAPT-FLEX study, right? And as Mike said in his script, that was a real-world evidence study of 17,000 patients showing, as you said, already great variability in the post-implant drug regimen that people are using out there in the real world. and certainly supporting the safety and efficacy of using DAP post-implant, no difference in death, no difference in stroke, no difference in bleeding, no difference in device-related thrombus, whether or not patients were treated with the on-label regimen of warfarin aspirin, DOAC and aspirin, or if they were treated with DAP post-implant. And that's why, again, we have a high degree of confidence that the data will support a label change within the coming months from FDA. You know, whether that change is going to have a material impact on what people are doing in the real world, you know, it certainly takes us to the point where, you know, Flex, you know, clearly superior to the competition out there in terms of safety and ease of use and post-implant leak takes away, you know, what may have been the only real differentiated feature the competition was using. But I think most people recognize already that whatever regimen you use post-implant, you're going to get a great result with Flex. I think in terms of the next generation Flex device, I don't think we're prepared to go into any, just as Mike said with Vortex, although we're a lot closer to the goal line on this one, really not prepared to go into any detail at this moment on the benefits that we see of the new device.
spk04: Understood. Thanks a lot for the answers.
spk06: The next question comes from Richard Newiter with Truist. Please go ahead.
spk08: Hi. Thanks for taking the questions and congrats on the quarter. You have some competitors out there that are calling out pricing strategies, particularly to head into 2023. Anything you'd call out there potentially as a lever to offset margin headwinds or sustain? And then also, if you could just comment a little bit more on the double-digit growth comment in the back half that you're expecting out of your Neuromod business? Any specific regions driving that? I'm assuming that doesn't assume a major pickup in SES, but other product categories, but please correct that if that's wrong. Thank you.
spk18: Yeah, and the pricing one, similar to some previous comments we've made, for us, it's all about our portfolio mix. and consistently diversifying the portfolio into more innovative, faster growing areas where we deliver great clinical benefit and markets that are potentially less price sensitive. And as many of you, as you're aware, we've reduced down dramatically, for example, the concentration of drug-eluting stents to quite a small percentage in the company. So as a result of all that, our pricing impact has improved year over year. It's still slightly negative for 2022, but it's improved versus 2021 versus each year. And hopefully in the near future will be a kind of break even and maybe even one day an upside of being positive price. But right now it's still slightly negative. Like any good company, and you heard earlier that our prices are too high in some areas, but like any good company, we try to, where we have differentiated value and economic proof, and it's appropriately profitable for hospitals, we try to take appropriate price increases. Difficult to do in some parts of our portfolio. Some of our hospitals are under longer-term contracts, but we do the best job we can when it makes sense for us and it warrants it with the customer. But overall, we're seeing not a neutral or positive price yet, but improving consistent price performance.
spk16: And on the Neuromod question, I can take that one. It's twofold. One is less COVID impact across those businesses in the second half. And then another is just simple math on the comps. The comps are minus one and minus seven for 2021 in the second half versus 19. So that's helpful as well. So that's the reason for the commentary around double digits on Neuromod for the second half.
spk18: Thank you. The minus one for third quarter. Yes, yes.
spk06: The next question comes from Jason Bedford with Raymond James. Please go ahead.
spk15: Good morning. Just two EP-related questions. It's a bit tough for me to get at here, but do you have an organic EP growth number in the international markets? Just ex-Balus, I guess. And then just secondly, on the Ferropulse rollout, you mentioned the supply chain challenges, but when do you expect to fully launch the product in Europe?
spk18: Yes, maybe, Dan, you can help me with the comp. Fair Pulse, in terms of an organic comp and Cryo, there were no sales prior to us buying the companies. So Cryo had no sales and neither did Fair Pulse. So they were essentially startups. And now you're getting some sales for both. So, Dan, maybe you can comment any further on that one. In terms of the supply chain for Fair Pulse, like many companies that deal with capital equipment and and chips and so forth. There's some challenges there. On the catheter side, we really aren't supply constrained, which is great news. So the team's done a great job on the catheter side. On the capital equipment, it's a bit tougher, but it's improving quarter over quarter and difficult to say when it would be unconstrained. But we continue to increase the number of new installations each month and each quarter.
spk16: And then, Jason, just on the EP numbers, international grew mid-teens. The total grew nine, so the U.S. grew less than nine.
spk06: Okay. Thank you. Now, Ms. Tengler, I understand there's time for one more questioner.
spk12: Yes, that's right, Andrew.
spk06: Thank you. Just one moment, please. The next question comes from Shagun Singh with RBC. Please go ahead with your question.
spk11: Thank you so much for taking the question. I was wondering if you can provide a little bit color on 2023. You did call out durable growth in the back half of this year. Directionally, should we expect that strength to continue into next year, just given your higher acuity exposure and despite a potential economic slowdown? What are the key catalysts we should look out for next year? And then you talked about some macroeconomic headwinds continuing into 2023, but the majority will impact a majority of the impact is going to come this year. Does that mean we can expect you to return to plus 50 basis points of operating margin goal in 2023 and beyond? Thank you for taking the question.
spk16: Yes, let me take the second part first. So just to be clear on my commentary, the commentary is there's $375 million of incremental impact in 2022 versus our pre-COVID 2019. The majority of that hits the P&L in 2022. It's balance sheet. It comes to the P&L in 2022. The commentary is not that that all goes away for 2023, that the commentary is relative to the macroeconomic 375. The majority of that 375 will hit the P&L in 2022. We fully believe that macroeconomic headwinds will persist into 2023. At what level? We don't know. We'll obviously be more, we'll see more over the second half And I think just overall, a bit early to be commenting specifically on 2023. We do see a very helpful backdrop from a revenue perspective. You see that in our first half performance this year. You see it in the guidance raise we had on the organic revenue for the second half. Durable, consistent revenue growth is a big piece of our strategy. You heard Mike talk about operating margin expansion and growing at the high end of our peer set for revenue. Those are all long-term tenets of the company. that we'll look to continue, you know, 23 and beyond. But specific numbers for 23, I think it's just a bit early.
spk11: Great. Thank you for joining us today. I'm sorry, just a key catalyst of the top line for 23?
spk18: There's so many. Yeah, it's really, you know, one thing about the company, you follow us, it's interesting. We will launch a bunch of new products in 2023, you know, especially, you know, in the U.S. Just talking about EP, hopefully it will be a bit more constrained there, and hopefully we'll launch our cryo platform potentially the second half of 23. We have many product launches each year, and it's really the strength of the diversity of the portfolio across the board. So we'll touch on it a bit more, but it's – Yeah, our portfolio doesn't change overnight. So it's so much of our current products and new enhancements that we'll continue to layer on top.
spk12: Thanks, Mike. Thanks for joining us today. We appreciate your interest in Boston Scientific. If we're 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, Andrew will give you all the pertinent details for the replay.
spk06: Please note, a recording will be available one hour in one hour by dialing either 1-877-344-7529 or 1-412-317-0088 using replay code 3825727 until August 3rd, 2022 at 1159 p.m. Eastern Time. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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