Boston Scientific Q3 2022 Earnings Call Transcript

Quartr
Provided by Quartr
October 26, 2022

There are 14 speakers on the call.

Operator

Good morning, and welcome to the Boston Scientific Third Quarter 2022 Earnings Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Lauren Tengler, Vice President, Investor Relations.

Operator

Please go ahead.

Speaker 1

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 Q3 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 Filings. The duration of this morning's call will be approximately 1 hour.

Speaker 1

Mike and Dan will provide comments on Q3 performance as well as the outlook for our business, including Q4 'twenty two and full year 'twenty two guidance. And then we'll take your questions. During today's Q and A session, Mike and Dan will be joined by our Chief Medical Officers, Doctor. Ian Meredith and Doctor. Ken Stein.

Speaker 1

Before we begin, I'd like to remind everyone that on the call, operational revenue growth excludes the impact of foreign currency fluctuation and organic revenue growth further excludes Acquisitions and divestitures for which there are less than a full period of comparable net sales. Relevant acquisitions include excluded for organic growth Our Preventis, Therapulse and Luminess Surgical, which closed in March, August September of 2021, respectively, as well as Bayless Medical, which closed on February 14, 2020 Divestitures include the BTG Specialty Pharmaceuticals, which closed on March 1, 2021. Guidance excludes the previously announced agreement to purchase the majority stake of MiTech, which is expected to close by year end 2022. 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.

Speaker 1

This call contains forward looking statements within the meaning of federal securities laws, 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 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 and D spend and other expenses. If our underlying assumptions turn out to be incorrect or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward looking Factors that may cause such differences include those described in the Risk Factors section of our most recent 10 ks 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.

Speaker 2

Thanks, Lauren. Thank you to everyone for joining us here today. We're very proud of our performance in Q3, particularly in light of the ongoing macroeconomic the winning spirit of our global team. Q3 'twenty two total company operational sales grew 14% versus prior year And organic sales grew 11.5%, which does exceed the high end of our guidance range of 8% to 10%. This performance is to our category leadership strategy and focus on innovation with strong commercial execution.

Speaker 2

6 of our 8 of our business units grew double digits organically, and we believe that nearly all of our businesses and regions grew faster than their respective markets. 3rd quarter adjusted EPS of $0.43 grew 6.3% versus prior year, at the low end of our guidance range of $0.43 to $0.45 Attributable to increased FX headwinds and slightly higher spend within the quarter. We have grown 9.2% organically year to date through Q3. And in light of this performance, we are increasing our full year 'twenty two guidance for operational growth to approximately 11.5% And organic growth to approximately 9%. For Q4 'twenty two revenue, we're guiding to operational growth of 8.5% to 10.5% And organic growth of 7% to 9%.

Speaker 2

We're also updating our full year 'twenty two adjusted EPS guidance to $1.71 to 1 $0.74 primarily related to the ongoing headwind from foreign exchange. Our Q4 'twenty two adjusted EPS estimate is $0.45 to $0.48 Throughout 2022, we have maintained our goal to improve operating margins. While our goal remains, we feel it's prudent to provide Updated adjusted operating margin target of approximately 26%, considering the continued macroeconomic pressures. On a full year basis, this does represent approximately 70 basis points of margin expansion versus our 2021 rate of 25.3%. I'll now provide additional Q3 highlights along with some comments on future outlook.

Speaker 2

Regionally, the U. S. Delivered operational growth of 12% versus prior year. Strong growth was realized across most all of our businesses, business units, particularly cardiovascular and endoscopy, including the approximate 300 basis point tailwind from acquisitions. Europe, Middle East and Africa grew 15% on an operational basis versus prior year.

Speaker 2

We continue to see excellent execution fueled by our innovative portfolio with 7 of the 8 business units growing double digits. Sales growth accelerated within our growth emerging market countries within Europe, with notable strength across cardiology and peripheral interventions. In Asia Pac, we grew 15% operationally with strong growth in China, India and ASEAN countries. While our Japan results saw some impact from COVID within the quarter, we continue to see strength driven by new products, including PolarX, Watchmen, Flex and Rezum. Our team in China delivered excellent results in Q3 with a growth of 36%.

Speaker 2

Growth is primarily driven by our ICTX business within cardiovascular, PI and our CRM business units, supported by new and ongoing product launches across Turning to Latin America, the team executed another exceptional quarter growing 29% operationally. All business units in major markets grew double digits in Q3 and across the portfolio more than 10 new products were launched, enabled by remote training and support. I'll now provide some thoughts on our business units, starting with Urology and Public Health, which grew organic sales 13% and 16% on an operational basis. The Stone Management, Prosthetic Urology and Prostate Health franchises all grew double digits in 3rd quarter with balanced performance across the regions. We continue to focus on global expansion and are pleased to have received approval and commence the launches of the SpaceOAR in both Korea, Mexico and Rezum in Japan.

Speaker 2

Our Luminus acquisition did turn organic in September, And we remain excited about the global opportunity ahead with the Moses Laser Technology, lithovu single use flexible ureteroscopes And our broad portfolio of stone management products. In endoscopy, sales grew 10% organically. Growth within the quarter was driven by our biliary and single use imaging franchises with ongoing market development activities enabling increased utilization of Exalt D and other key products. In Neuromodulation, organic revenue grew 3%. Our pain franchise sales were flat year over year, In SCS, while international growth was very strong with broad demand for WaveWriter alpha, our U.

Speaker 2

S. SCS sales were by pre authorization denials despite strong patient demand and ongoing physician interest in our fast therapy. We have a team in place focused on supporting the pre authorization documentation requirements. However, we do anticipate that challenges will continue to persist in the 4th quarter. In deep brain stimulation, the U.

Speaker 2

S, EMEA and LATAM regions grew double digits in the 3rd quarter. Globally, we're seeing stable underlying DBS procedure growth, We continue to see momentum in the U. S. As we moved into full launch of our StimView XT integrated imaging and programming platforms. Cardiology delivered another excellent quarter with organic sales growing 13% and operational sales growing 16%.

Speaker 2

Within cardiology, Interventional Cardiology Therapies, organic sales grew 11%. This coronary therapies franchise performed well in Q3, driven by strong performance in our international regions, particularly with our differentiated imaging franchise. Importantly, we recently completed enrollment in our AGN IDE trial. This is the very first U. S.

Speaker 2

Trial for a coronary drug coated balloon to treat instant restenosis, and we expect to launch in Japan in 'twenty three and the U. S. In 2024. Our structural heart valves franchise did grow double digits in Q3 again with continued strength in Europe with our ACURATE NEO2 TAVR platform. Additionally, results from the protected TAVR trial were presented as a late breaker at TCT.

Speaker 2

Recall the protected TAVR trial studied our cerebral embolic protection Device, SENTINEL with TAVR versus unprotected TAVR. With a reduction in the primary endpoint of overall stroke, While the reduction in the primary endpoint of overall stroke did not reach statistical significance, a secondary analysis demonstrated a clinically meaningful 63% relative risk reduction in severe disabling stroke. Turning to WATCHMAN, organic sales grew 26 percent in Q3. Global growth continues to be very strong, further supported by the U. S.

Speaker 2

FDA approval of an expanded label to include DAPT, giving physicians and patients choice of DAPT or OAC in the 1st 45 days post implant. We continue to focus on innovation in this space with the TruSteer, which is our new steerable sheath, and we also highlighted our next generation flex device, WATCHMAN and FlexPro at our TCT Investor event in September. We expect FlexPro to build on our 2nd generation Flex with additional sizes and a device coding designed to enhance healing. In cardiac rhythm management, organic sales grew 7% versus prior year. We had another strong quarter as we continue to focus on lifetime patient management from diagnostics to implant with our broad portfolio.

Speaker 2

Within Core CRM, our low voltage franchise grew mid single digits and high voltage grew low single digits. Our diagnostics franchise continues to perform very well. We're pleased to have received CE Mark for our implantable cardiac monitor, LuxDx, and we have commenced our commercial launch. Electrophysiology sales grew 26% on an organic basis and 83% on an operational basis. We continue to see strength in our comprehensive international portfolio, which grew 45% organically, and this includes 2 months of contribution from ParaPulse.

Speaker 2

Physician demand for Polarex in Japan and Feripulse and Polarex in Europe remains very strong, And we continue to see increased utilization at existing centers, while we are expanding into new accounts. In addition, we're pleased to have launched VERIPULSE in Australia and Singapore under special access, and we anticipate approval in 'twenty three. The Bayless integration continues to go well with the differentiated transseptal access portfolio growing double digits in the quarter and remains on track to achieve our full year expectations. In peripheral interventions, organic sales grew 12% with broad growth across all major franchises In arterial, our differentiated drug eluting portfolio grew double digits in the quarter, and we received FDA approval for a line extension of Eluvia And commenced launch of the longest length of drug lumustat for peripheral arterial disease in the U. S.

Speaker 2

The interventional oncology business had another very strong quarter With great growth and continued strength in our cancer therapies, ICX and TheraSPHERE. We're pleased to have closed an acquisition of Sorry, Obsidio and the gel embolic material technology. Obsidio is the 1st gel embolic with an indication for the peripheral vasculature and a complementary addition to our portfolio. We look forward to launching this technology within the U. S.

Speaker 2

In 2023. In alignment with our overall commitment to progress our environment, social and governance efforts, the PI division announced collaboration with the healthcare data platform, Truvita, aiming to provide insights to help better address healthcare disparities within various PI disease states. We remain committed to driving Sustainable innovation of Boston Scientific and despite the persistent macroeconomic pressures, we continue to invest for the long term in R and D, Execute strategic tuck in M and A with a focus on improving patient outcomes today and into the future. We're also excited about ahead and remain focused on our long term financial goals, continuing to grow sales faster than the markets, operating margin expansion, Double digit adjusted EPS growth and strong adjusted free cash flow generation. Before I turn it over to Dan, I do want to take a moment to share That our Chief Medical Officer, Doctor.

Speaker 2

Ian Meredith will be retiring in April of 2023. We're extremely grateful for his strong contributions, Particularly his dedication to patients, clinical science and meaningful innovation and his great sense of humor. With that, I'll now turn things over to Dan

Speaker 3

to review our financial performance in more detail. Thanks, Mike. 3rd quarter Consolidated revenue of $3,170,000,000 represents 8.1% reported revenue growth versus Q3 2021 and reflects a $162,000,000 headwind from foreign exchange, higher than our expectations due to the continued strength of the U. S. Dollar.

Speaker 3

Excluding this 550 basis point headwind from foreign exchange, operational revenue growth was 13.7% in the quarter. Sales from the acquisitions of Farapulse through July, Luminus through August and Bayless contributed 220 basis points, resulting in 11.5 percent organic revenue growth, exceeding the high end of our guidance range of 8% to 10% growth versus 2021. Continued foreign exchange headwinds and slightly higher spend on R and D investment across the portfolio largely offset our top line outperformance, resulting in Q3 adjusted earnings per share of $0.43 achieving the low end of our guidance range, representing 6.3% growth versus 2021. Adjusted gross margin for the Q3 was 70.7 percent, in line with our expectations. The macroeconomic environment continues to be challenging, particularly related to inflationary pressures and availability of materials, which have largely offset a slight improvement in freight costs.

Speaker 3

For full year 2022, we continue to expect adjusted gross margin to be slightly below 70.8%, which includes $375,000,000 in macroeconomic headwinds versus 2019. These headwinds are predominantly from increased freight costs And unfavorable manufacturing variances primarily related to direct material cost and availability with a smaller portion attributable to increased labor costs. Recall, unfavorable manufacturing variances are recognized over approximately 6 months, in line with our inventory turns. 3rd quarter adjusted operating margin was 25.5%, slightly lower than our expectations. Target to allow for the flexibility to weigh near term spend discipline with investments to continue to fuel top line growth.

Speaker 3

We now expect full year adjusted operating margin to be approximately 26%. One time charges within the quarter's results included a minor write off related to the continuation of our SAVAL program. In addition, we recognized a GAAP charge attributable to an intangible asset impairment of $125,000,000 primarily related to Vertiflex as the business continues to face reimbursement challenges impacting the revenue outlook for the product. On a GAAP basis, the 3rd quarter operating margin was 11.3%. Moving to below the line, adjusted interest and other Expense totaled $91,000,000 in Q3, higher than our expectations, driven in part by FX losses from certain unhedged currencies.

Speaker 3

Our tax rate for the Q3 was 11.9% on an adjusted basis, including discrete tax items and the benefit from stock compensation accounting. Excluding these items, our operational tax rate was 14%, in line with expectations. We ended Q3 with 1,440,000,000 Diluted weighted average shares outstanding. Adjusted free cash flow for the quarter was $626,000,000 And free cash flow $320,000,000 with $470,000,000 from operating activities, less $150,000,000 net Capital expenditures. We now expect our full year 2022 adjusted free cash flow to be approximately $2,000,000,000 Our total legal reserve as of September 30th was $304,000,000 a decrease of $210,000,000 versus June 30th, primarily related to mesh and certain IP litigation payments.

Speaker 3

As of September 30, 2022, we had cash on hand of $338,000,000 Our top priority for capital allocation remains high quality tuck in M and A and we'll continue to assess opportunities in conjunction with our As of September 30, our leverage was 2.5 times and we now expect year end leverage to be at or slightly below 2.5 times. I'll now walk through guidance for Q4 and the full year 2022. We expect full year 2022 operational revenue growth to be approximately 11.5% versus 2021, which excludes an approximate 500 basis point headwind from foreign exchange based on current rates, 100 basis points higher than our previous expectations. Excluding a 250 basis contribution from the acquisitions of Preventis, Therapulse, Luminus and Bayless and $13,000,000 of Pre divestiture specialty pharmaceutical sales in 2021, we now expect full year 2022 organic revenue growth to be approximately 9% versus 2021, reflecting our strong Q4 performance and confidence in continued consistent procedural growth. We expect Q4 2022 operational revenue growth to be in a range of 8.5% to 10.5% versus 2021, which excludes an approximate 650 basis point headwind from foreign exchange based on current rates.

Speaker 3

Excluding a 150 basis point contribution from the acquisition of Thales, we expect Q4 2022 organic revenue growth To be approximately $350,000,000 Full year 2022 operational tax rate expectations remain unchanged At approximately 14% with an adjusted tax rate of approximately 13%, including the benefit of the accounting standard for stock compensation discrete tax items recognized year to date. Our tax rate expectations reflect current legislation, including a provision on the treatment of R and D expenditures. We continue to believe there's bipartisan support to reverse this provision, and if such legislation were to be enacted, we would expect our full year tax rate We expect a fully diluted weighted average share count of approximately 1,443,000,000 shares for Q4 2022 and 1,440,000,000 shares for the full year 2022. Our long term hedging strategy continues to be effective at minimizing FX impact on EPS And we are largely hedged through 2023. At current rates, we now anticipate FX headwinds on our full year 2022 adjusted earnings per share of $0.06 which is $0.03 unfavorable versus previous expectations due to the continued strengthening of the U.

Speaker 3

S. Dollar. As a result, We are updating our full year adjusted earnings per share range to $1.71 to $1.74 representing 5% to 7% growth versus 2021. We expect 4th quarter adjusted earnings per share to be in a range of $0.45 to $0.48 One quick housekeeping item before I turn it back over to Lauren. We continue to expect full year 2022 preferred stock dividend expense of approximately $55,000,000 related to our May 2020 mandatory convertible preferred stock offering using the if converted method.

Speaker 3

These shares will mature on June 1, 2023, at which point the dividend expense will retire and our share count will increase based on our share price at the time of conversion. In each of the conversion scenarios, the resulting impact to EPS should be immaterial. For more information, please check our Investor Relations website for Q3 2022 financial and operational highlights, which outlines more details on Q3 results and the MCPS share conversion. In closing, I'm proud of the results we've achieved year to date Continued revenue momentum and despite a challenging macroeconomic environment, we remain focused on operating margin expansion balanced with investment in our innovative portfolio And with that, I'll turn it back to Lauren, who will moderate the Q and A.

Speaker 1

Thank you, 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.

Operator

We will now begin the question and answer session. The first question comes from Robbie Marcus with JPMorgan. Please go ahead.

Speaker 4

Great. Thanks for taking the question and congrats on a great top line quarter. I'll also add congratulations Doctor. Meredith on a very well deserved retirement. Maybe for my question, It really was a strong top line, double digits organic.

Speaker 4

4th quarter continues to look good in guidance. I think the one Area where we're seeing a little pressure is on margins. So Dan, I was hoping you might be able to give us an early look into next year. Do you think the Street's generally in a decent spot for next year with returning to more normalized margin expansion? Or do you think It's still going to be a pressured year in 2023.

Speaker 3

Thanks. Sure, Robbie. I think, obviously, early To comment on 2023 specifically, but I think I can probably give you some commentary that will be helpful. First, you mentioned share count. That shouldn't really be a driving factor, because I mentioned on the conversion of the MCPS that, that shouldn't really impact next year's EPS once converted.

Speaker 3

Let me look at Q3 first though. If you look at EPS for the quarter, given the reported revenue at the high end of the range, it's probably reasonable to expect that we would have been at the high end of the EPS range, which was $0.43 to $0.45 We achieved $0.43 which is 0 point 0 $2 lower than the $0.45 a $0.01 of that is from the incremental FX headwind and a $0.01 is from lower operating income percentage versus expectations in the quarter. I think the FX impact, I think, is well understood given the strengthening of the U. S. Dollar.

Speaker 3

So not a lot of additional commentary there. Relative to our operating income percentage, The goal is to be 26% for the full year, and this involves balancing certain initiatives to reduce expenses in the short term to offset the supply chain and inflation headwinds, while at the same time continuing to fuel our top line, which has been performing very well. If you look at the P and L components of a 26% adjusted margin scenario in 2022, it would likely have gross margin higher than 2021, SG and A lower 2021 and R and D slightly higher than 2021. And we think this is appropriate. And keep in mind, as Mike said, This would be 70 basis points higher than the 2021 adjusted operating income margin full year of 25.3 percent and in line with the 2021 second half And importantly, in line with 2019 full year, while absorbing $375,000,000 of supply chain and inflation headwinds compared to 2019.

Speaker 3

So I feel very good about how we're balancing that and looking at that 26% as a very successful number for the year. Specific to 2023, Again, our goal is always to continue to increase operating margin, long standing goal of doing that 50 basis points per year. If you look at the 25.3% last year, we'll be 70 basis points, as I said, advanced on that in 2022, if we hit that 26%. And then even with where we were in 2019 and the second half. So more to come as we evolve And deliver guidance likely in that February timeframe, but I feel good where we are in 'twenty two and look forward to continuing the journey in 'twenty three and beyond.

Speaker 4

Great. Appreciate the color. Thanks.

Operator

The next question comes from Larry Biegelsen with Wells Fargo. Please go ahead. Good morning. Thanks for taking the question. I just wanted to ask about neuromodulation.

Operator

Mike, could you talk a little bit about more The reimbursement challenges there, what channels are you seeing that in? And it seems like all your businesses are consistently growing Around the corporate growth rate except Neuromodulation. So what's the plan to accelerate the growth in that business? And let me just also Stan, my congratulations to Doctor. Meredith and I wholeheartedly agree with your comments earlier, especially about his sense of humor.

Operator

Thanks for taking the Questions?

Speaker 2

Hey, Larry, yes, we're quite proud of the performance. Nearly every business grew double digits and faster than the peer group And every region as well. You saw the growth in Europe and China and all of us. We're quite proud of the results in the quarter And really through the year. Neuromod, they're really broken down in 2 pieces.

Speaker 2

The deep brain stimulation franchise is doing extremely well, Growing strong double digits, U. S, Europe and a nice pipeline. And we're not seeing really some of the macro headwinds in the DBS business. On the spinal cord stimulation business, as you know, this market has been tough to call, really over the past few years during the pandemic. And now as we're essentially hopefully getting out of the pandemic, the markets we think in the Low single digits to potentially mid single digit range now.

Speaker 2

So it has come down a bit, in terms of the overall market growth rate, we believe. What's hurting the market, not necessarily B. S. Boston Scientific, as you've seen some competitive results already and you've seen this trend throughout the year, Has been in the spinal cord stimulation market in the U. S.

Speaker 2

And we're seeing more pre authorization denials In the U. S, we are seeing strong patient funnels. So our team is essentially really focused on building additional capabilities to Our physician customers manage those pre authorization dials. These patients need the products. The products obviously work.

Speaker 2

I think this is more of an industry challenge right now. And we're working with them to streamline that authorization process to get patients through the funnel and physician to get paid. So we do anticipate that headwind will persist in Q4. Hopefully, it will get better in 2023. Us, like our competitors, will have easy comps in 2023 based on this.

Speaker 2

So that helps mathematically. But fundamentally, we need to improve the Help our patients and customers with this pre authorization hiccups and some of the capabilities we're building to assist them with that. But I think it's more of a Class issue right now than a Boston Scientific issue.

Speaker 5

Thank you so much.

Operator

The next question comes from Joanne Wuensch with Citi. Please go ahead.

Speaker 1

Sorry, thank you very much for taking the questions. Can we spend a little bit of time on the WATCHMAN franchise? You've had Over the last 12 months, increased competition, but an improved label and sort of a broader geographic reach. Can you pick apart how those segments are going or how those headwinds and maybe not headwinds are impacting the franchise? Thanks.

Speaker 2

Sure. The Watchmen business had a terrific quarter. It grew 26%, the bulk of that growth coming from the U. S. We have launched recently in Japan, albeit a bit slower given the COVID situation there and the need for more proctoring, but that should have A bigger impact for us in 2023, similar results in China.

Speaker 2

I would say same commentary, a bit slower out of the gate given some of the COVID restrictions, We should get better in 2023. We've also continued to gain share in Europe, which I think is important. But by far, the most important market is the U. S. And the team there has done an excellent job.

Speaker 2

It's really a comment similar to previous calls. You did call out the DAP label. That did have some additional momentum for us In Q3, some physicians kind of converted back to WATCHMAN FLX now that we've had that label. And really, it's the consistent ease of use, the safety benefits and the support that The implanting cardiologist or EP is receiving from the referrer. The referring community is getting more and more confident in WATCHMAN in particular each quarter.

Speaker 2

And so we expect the market to continue to be quite healthy. We're calling it roughly 30% growth. We're investing in the clinical trials that you're aware of with Option Champion to further widen the market opportunity for it, and we have a very strong pipeline of new products coming behind what is already a differentiated from So we think we're in really good position here and we're going to continue to grow the market and invest to have this be one of our top growth drivers.

Speaker 1

Thank you very much.

Operator

The next question comes from Vijay Kumar with Evercore. Please go ahead.

Speaker 6

Hey, guys. Thanks for taking my question. Dan, maybe one for you on the financial side here. I think The 26% operating margin for the year, that would imply Q4, the pretty steep ramp in Q4. Are we thinking about margins the right way?

Speaker 6

And when you think about those margins, what should FX impact be for next year at current rates? Anything to think about, balance sheet inventories, which have been capitalized that flowing through the P and L for next year, any impact for our 2022? Thank

Speaker 3

Sure. Relative to did you say, MJ?

Speaker 6

Yes, I meant the inventory impact for 'twenty three, sorry, not 'twenty two.

Speaker 3

Yes, right. Got that. Specific to Q4, so your math is right, right? We're 25.5% year to date adjusted operating margin. So it implies the 27.5% for the Q4 to get to the full year 'twenty six percent.

Speaker 3

We believe we have the plans in place to do that. There's a bit of a seasonality If you look back over the past few years, Q4 is usually the highest margin quarter we have, both gross and operating. So we're looking for that trend to continue In Q4, so but yes, it requires a strong Q4, but we believe we have the plans in place to deliver that. Specific to 23, I probably can be a little bit helpful on that. I think somewhat unique to us in our hedging program, we do hedge out multiple years In that program, so as I mentioned in my commentary, we are largely hedged for 2023.

Speaker 3

So if rates were to stay where they are today, I think you'd likely see an impact in 'twenty three of pretty similar to what you see this year on earnings per share. Recall, at the operating margin percentage Level, you don't see much benefit from FX. You see that in the gross margin, but then because our The majority of our OpEx dollars are dollar denominated. You lose that in the OpEx section of the P and L. So the operating margin contribution From FX is very minor.

Speaker 3

So not much to talk about there, but relative to EPS impact, I would say likely similar to what you see this year assuming Rates remain constant.

Speaker 7

Thanks guys.

Speaker 2

Thanks for your

Operator

time. The next question comes from Travis Seed with Bank of America. Please go ahead.

Speaker 5

Hey, thanks for taking the question and Also congrats to Ian Meredith. I might have missed it earlier, but can you remind us again the moving parts on what drove the higher OpEx and the lower Op margin guide for 20 2 versus 3 months ago, just as a quick clarification. And then the question I was going to ask was more on the Analyst Day last year, you were committed to a double digit EPS growth CAGR, this year you're close to 7%. Is that double digit EPS CAGR still good? And can the starting point for 2023 And still be in that double digit range given the macro pressures that we're in?

Speaker 3

Yes, on the double digit Earnings per share, that's always been our growth goal and we've achieved that many years. The issue this year is a change in Tax legislation that was that went into effect in January, and that is about $0.06 overall for the year. So if that were the old legislation, we would be solidly double digits. So It's a provision on the amortization of R and D within tax. And so that's really The stick in the spokes are getting to double digits this year.

Speaker 3

Double digit remains our goal going forward as we talked about at Investor Day.

Speaker 2

And then your first question was, I would just comment, there's a lot of focus on with Aviomed Society and others And advocating for that R and D amortization to reverse. So that is a one timer that will annualize in 'twenty three. And if you neutralize with that and Some of the FX were strong double digits for the year.

Speaker 5

That's helpful. And if you could just remind us the moving parts on the 2022 margin guide, exactly what The higher OpEx and what drove the change in op margin again? I may have missed that earlier.

Speaker 3

Yes, it's really just a balance within the P and L. So If you think of where we are versus 2021, you'll see higher gross margin, you'll see lower SG and A and you'll see slightly higher R and D. So we're balancing The P and L to try and offset the $375,000,000 of headwinds that we have versus 2019 and just maintaining The appropriate level of spend in that R and D line to continue to fuel the top line. So that's really the only tweak within there. So Making sure that we fuel the top line while still trying to offset the supply chain and inflationary headwinds.

Speaker 5

Great. Congrats on the good top line.

Speaker 3

Thanks.

Operator

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

Speaker 8

Great. Good morning and thank you for taking the questions. Just wanted to ask A bit more color on what you saw exiting September versus July August across your portfolio. And then looking at the 4Q guide, if you could just walk through And expectations either U. S, OUS, what you're looking at for China and then just expected either seasonality, any impact From deductibles, anything you would call out specifically that you incorporated in the 4Q guide?

Speaker 8

And thanks for taking the question.

Speaker 3

Yes. I mean, I think, seriously, I don't think we're going to get into the specifics of the quarter. I mean, we're I think the revenue results stand in their own. We're super proud of the 11.5% organic growth in the quarter. So I think that speaks for itself.

Speaker 3

Relative to Q4, obviously, we're giving guidance today. We know where we are Through October, the through where we are in October. And Neuromod, as Mike said, Neuromod is probably a bit challenged in Q4 versus what we might have expected 90 days ago, but The rest of the business has tremendous momentum and again super proud of the 11.5% that we delivered in Q3, again with most of those businesses in double digits.

Speaker 2

You asked about the regions. You saw the U. S. Performance in Q3 and for the full year is quite strong, but and also a particular strength Europe and Asia Pac and our China business grew over 30% in the quarter. It's done extremely well this year based on the diversification of the the portfolio and the product launches and really the innovation of the team in China and also shout out to the European team.

Speaker 2

In a very mature market, it continues to grow double digits in the kind of Western more established markets and very strong double digits in the emerging markets there. So you're seeing really balanced growth across each region throughout the year. And many of those products, as I mentioned in the script, In Europe, particularly in EP, we're working on clinical trials to get these products through and approved in the U. S.

Speaker 8

Thanks for taking the question.

Operator

You're welcome. The next question comes from Rick Wise with Stifel. Please go ahead.

Speaker 9

Hi, Mike. Hi, Dan. Two questions. Maybe just on the recovery, just one large picture and one product question. On the recovery, obviously, FX is an unavoidable factor that's going to continue.

Speaker 9

But I'm curious to what extent are some of the other Macro headwinds stabilizing or even improving, particularly staffing, I keep saying to myself, if staffing were less of an issue, Maybe you would have grown even more rapidly. Is staffing still an issue? Are things stabilizing in general on the freight and cost side are getting worse? And then I have a product follow-up question.

Speaker 2

Sure. On the hospital staffing, you've seen some of the big public companies hospital Change our report. Maybe it's gotten incrementally better, but certainly still quite a challenge for hospitals. Despite that, The procedure volumes are quite healthy, despite some of the staffing shortages. Could they be a little bit better if their shortage were improved?

Speaker 2

Likely. But they're doing a nice job of managing it and it's forcing us to be innovative with them on reducing procedure times, which we continue to do find ways through our portfolio. So staffing may be slightly better, but still a very tough environment for hospitals It might provide some upside over time as that gets better, but it's going to get better more slowly, not overnight. And the other headwinds, we've talked about, But Dan, I think the $375,000,000 ish of incremental supply chain bucketed supply chain costs versus 'nineteen. And the biggest We are seeing some slight improvement in some of the freight areas and we expect some slight improvements ongoing there In 'twenty three, the bigger bucket that's most impactful is the product cost, the material cost, the supplies and raw materials that we purchase.

Speaker 2

And due to some of the shortage there, we have tied up some longer term contracts to ensure supply, but those have come at more hefty price increases. So that bucket, we don't see getting better in 2023. So we think we'll carry that forward in 2023 as you annualize those contracts. Some of the other areas will get more efficient, the productivity of our manufacturing plants and so forth. So as Dan mentioned, we expect to carry many of these supply chain headwinds primarily from material cost into our 2023 plans.

Speaker 2

But similar to this year, we did improve margins 70 bps versus 21. Our goal will be to continue to improve margins in 2023 and manage through that.

Speaker 9

That's great, Mike. And just it's hard to resist asking about Ferra PULSE. It sounds like things are going extremely well. Can you talk about drivers of the demand for Ferra PULSE in Europe? Maybe any incremental color on centers opened?

Speaker 9

And And just maybe update us, remind us if everything is still on track for data U. S. Data readout in 2023 And approval in 24. Thank you again.

Speaker 2

Thanks, Rick. I'll let Doctor. Stein cover that one.

Speaker 3

Yes, sure. Thanks, Mike, and thanks, Rick, for the question. Very pleased with the commercial rollout in Europe to date, both in terms of continued pre procedure growth at the centers Where we have opened and being able to open new centers as we continue the product launch. And I think that the drivers are Really, what we've always said is the promise of the Farapulse technology, right? It's enhanced safety as compared to thermal ablation.

Speaker 3

It's proving to be at least as efficacious, if not more effective. And certainly, as Mike mentioned, in terms of the issue with Headwinds with staffing, it's a much more efficient procedure and really just couldn't be happier With what we're seeing in terms of outcomes in Europe to date, we have completed enrollment in our U. S. IDE trial that was the ADVENT trial And again, still on track to finish follow-up for the primary endpoint of that data in sort of Mid term next year and then submit to the FDA and then it's all in the hands of the regulators.

Speaker 9

Thank you very much.

Operator

The next question comes from Matthew O'Brien with Piper Jaffray. Please go ahead.

Speaker 7

Good morning. Thanks for taking the question. And let me offer my congratulations to Doctor. Meredith as well on his retirement. Mike, it seems like you're taking a little bit of near term pain right now to continue your spending In these growth areas because you continue to be one of the faster growth diversified medtech names out there.

Speaker 7

So I'm just curious If you feel like that momentum is going to continue into 2023 where you can stay one of the faster growth large cap Med tech names out there. And if it's going to be more of a broad based level of improvement across all the different Franchises where you can keep kind of growing in this double digit range in some areas or if it's going to be a little bit more focal than what we've seen historically. I don't know if

Speaker 2

Sure. What you've seen the performance this year It's pretty consistent across all of our divisions. 6 of 8 grew double digits in the quarter. You've seen similar performance throughout the year because of the Innovation and commercial teams that we have and our each quarter, as we mentioned many times, the lower growth markets, That mix of those businesses get smaller each quarter, and we layer on M and A and new innovation to grow faster. So that's kind of our formula, It's proven to work pretty well.

Speaker 2

As we look in some of the decisions that we make, we're very excited about the portfolio Of significant launches that we have, most of the significant very significant Movable meeting launch Move the needle launches are more in the 'twenty four, 'twenty five period, and that's where you're seeing the great growth in Europe, Whether it be our Acura NeoValve, the agent balloon that we're excited about, which we think will change really the script in coronary That will launch next year in Japan. And as Doctor. Stein just mentioned, our EP portfolio with Feripulse and Cryo is doing Well, outside the U. S. And we have other launches.

Speaker 2

So that does require quite a bit of R and D and clinical work. We'll be starting a persistent trial with Verapulse in the coming months here. So we think our R and D spend is appropriate to fuel that consistent Above peer market growth over the LRP. In 'twenty three, we'll give guidance in February. We will have a bit tougher comps in 'twenty three based on The estimated 9% growth this year, but if you look at we're excited what 'twenty three will bring and we'll give more guidance there.

Speaker 2

But if you look at the company And what we have for the future based on what we're seeing in Europe and the clinical science that we're delivering, whether it be in our interventional oncology business or EP business, We're quite confident in the next LRP that will consistently grow above the peer group.

Operator

The next question comes from Matt Taylor with Jefferies. Please go ahead.

Speaker 7

Hi. Thanks for taking the question. Can you hear me okay?

Speaker 3

Yes. I hear you fine, Matt.

Speaker 7

Thanks, Dan. Okay. So I wanted to Back and just ask one about Q4. Just on the 7% to 9% organic versus the 11% plus that you did this quarter, obviously the comp It's tougher, but is there anything else you call out there? Are you seeing anything slow down?

Speaker 7

Are you being conservative? Any highlights on

Speaker 3

I think it's really just the comp, which is the better part of 2 50 basis points more difficult. And neuromod is lower than the average of the rest But as we've continued to say, 6 of 8 double digits in Q3, continued momentum with a lot of the good new product launches we have, both in the U. S. And Internationally, so I think the business has great momentum. And I think once you clear for the comp, it's a great Q4.

Speaker 3

And we deliver 9% organic revenue growth for the full year versus 2021, I think that would be a great year for the company.

Speaker 7

Great. Can I ask one follow-up? I just wanted to know, you heard more about pent up demand Signs from some of the other peers that have reported. Would you espouse that be are you seeing signs of that start to come due? And how do you square that, I guess, With staffing getting slightly better, what are the things that I guess could release over the next couple of quarters to help with the volumes?

Speaker 2

Yes, we think the volume is pretty good. And there is certainly pent up demand, but It's been in the system for a while. You look at your typical backlog, whether it be a knee replacement or a AFib product or whatever Immense health implants, oftentimes you're getting a 60 to 120 day wait in the U. S. And so there's certainly pent up demand, But I don't see that getting cured in the near term.

Speaker 2

I think there's just a very strong patient demand. There is a bit of a staffing shortage. There's only so many labs that a hospital has to do procedures. And so we see pretty strong volume, Which I guess is a good sign for the future here. Despite some of the staffing shortages and just hospitals extremely busy, Lab time very busy and demand that outstrips their supply in many cases that drive the waitlist.

Speaker 2

But we don't see that Wait list dramatically changing in the coming months.

Speaker 7

Thanks, Mike. Thanks, Tim.

Operator

The next question comes from Tito Chickering with Deutsche Bank. Please go ahead.

Speaker 10

Hey, good morning guys. Thanks for taking my question. Now it's been a while since the last COVID spike. Have you seen the funnel for patients to get procedures normalized across your product Folio versus pre COVID levels, are you seeing any bottlenecks within that funnel as you think about your organic growth? And just to be clear, This isn't about necessarily nurse staffing at hospitals, but all the

Speaker 2

touch points across healthcare system. Thank you. I think it's similar to the last response. It depends on the region of the world. We did see slowdown In Q3 in Japan, and you see pockets in China and sometimes pockets all over the world depending on what happens with COVID.

Speaker 2

But overall, that's being smoothed out with the underlying pretty good procedure growth and us doing a bit better. And so again, I think as you look to Q4 in 'twenty three here, staffing shortage is still is an issue. It's not going to be resolved in 'twenty three. Hospitals are being very innovative To try to shore that up, but it's strong patient demand, common to see longer wait list. So we do see pretty consistent demand, But we don't see a quick fix for the staffing shortage, but the underlying demand is still strong despite that.

Speaker 2

Great. Thanks so much.

Operator

The next question comes from Chris Pasquale with Nephron Research. Please go ahead.

Speaker 11

Thanks. I wanted to follow-up on the increased prior auth denials in Neuromod. You talked about helping physicians Documentation, but what about addressing the underlying payer reticence to allow access to those therapies? Do you think more clinical data can help and what have you

Speaker 2

I don't really much more to comment on. The team does quite a bit With our clinical studies that we do for product approvals, it's a well accepted therapy across It's been it's a pretty mature market in terms of number of competitors and clinical science that's actually increased quite a bit the last few years. Part of it is the payers. We certainly work with our Hema teams to contact those payers directly and reemphasize that clinical evidence. But it's really a bit of a just some of the recent pre authorization denials that just need to be worked through in terms of their efficiency, And we aim to improve that process.

Speaker 3

Got you.

Speaker 7

I

Speaker 2

don't think it's related to any It's not related to slowdown, it's not related to any poor clinical data. There's good clinical data at Boston Scientific and our peer group, And it's well established by the implanter, whether it be a pain physician or a orthopedic physician. It's well proven out. I think it's working through some of the mechanics of these pre authorization denials is the issue. But I also think overall the market is a bit slower, Even excluding that than it was historically.

Speaker 11

Okay. And then renal denervation is going to

Speaker 5

be a hot topic at Boston

Speaker 2

Doctor. Meredith, I'll take that one.

Speaker 12

Yes. Thanks, Chris. It's a good question. Yes, we will see Medtronic's hypotension study Come out at and we just saw the RADIANCE II trial results come out at TCT with ultrasound. This is a real therapy and hypertension is an enormous cardiovascular problem globally and we follow this space very carefully.

Speaker 12

This is a significant opportunity. Obviously, the results still could be improved. If you look, there's Significant variability in the treated arm effect, and that probably reflects that we've got more to do to understand In whom we should be using this form of therapy, but it's a real opportunity. Hypertension is a massive cardiovascular problem. We follow the field very closely.

Speaker 12

It's one that we have to pay attention to.

Speaker 11

Thanks and congrats Doctor. Meredith.

Speaker 12

Thank you.

Operator

And I understand there's time for one last question, and that would be from Matt Miksic With Barclays, please go ahead.

Speaker 13

Hey, thanks so much for squeezing me in. Hey, how are you? So congrats on a really strong quarter. And Doctor. Meredith, we'll certainly miss your insights And your cheerful disposition.

Speaker 13

And I guess I'm thankful to that I've got about 6 months to Good to know this humorous side that everyone's referring to. So I look forward to that. Just one follow-up, if I could, on margins. Dan, you talked about the impact of FX and it seems like that explains pretty much the $0.03 reduction in EPS Guide for the year. Just maybe one question on trajectory.

Speaker 13

You know, you saw just strong Q3 here. You're adjusting Q4 for EPS and top end of the range for organic growth. That strikes me as a little bit conservative, just given the strength, but I'd love your comment on that. And then maybe You're not talking much about 'twenty three, but the shape of margins. I know there's been a lot of questions around how far into 'twenty three Some of the higher costs will go.

Speaker 13

And if we were to think about, is that sort of a front half, back half that we should be thinking about for 23 at this point? Or Sure, it's too early to say, but any insight you can give on how we should think about costs as they roll through inventory, P and L and so on. Thanks so much.

Speaker 3

Sure, Matt. A lot to chew on in that question. So the first, I agree with your assertion. The $1.71 to $1.74 from the $1.74 to $1.77 adjusted earnings share guidance for the year, that is FX. That's down $0.03 FX is the FX impact on EPS was $0.03 it is now $0.06 So that is the difference for the $171,000,000 to $174,000,000 change in guidance.

Speaker 3

On the revenue for Q4, your comment that it appears conservative, think it's appropriate. I think we've looked at all the different variables that are there, the momentum in the business, and we think that the guidance we gave is appropriate. And I think for 2023, I think it's just a bit early. I mean, I gave you a little bit of a teaser there on FX given where we are with our hedging program. I think other than that and obviously that our goal is to continue to expand operating margin over time.

Speaker 3

But other than that, I'll probably just Let you wait until we give guidance officially on all the specifics, but super excited about how the company has performed this year

Speaker 1

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 Before you disconnect, Andrew will give you all of the pertinent details for the replay. Thank you.

Operator

Please note, a recording will be available in 1 hour

Powered by Quartr
Earnings Conference Call
Boston Scientific Q3 2022
00:00 / 00:00