Boston Scientific Corporation (BSX) Earnings Call Transcript & Summary

Okay. Good morning, everyone. Thanks for joining us on Day 2 of HealCoNext. Pleasure to have Boston Scientific kick off day 2 for us. We have Jeff Mirviss, President of PI. That's Peripheral Interventions. We also have Cat Jennings, President of Peripheral Vascular and from Investor Relations, we have Lauren Tengler. Before we start, I have to say we're used to asking, what is the utilization big picture? How is acute trending? And when we get down to segment level, sometimes I have to do some work. So I learned a lot about PI, preparing this Q&A list. So thanks for taking the time this morning, Jeff and Cat.

Pleasure to be here.

So Jeff, maybe starting with some big picture questions for you. Give us a little bit of macro, big picture on what PI is. It's a $2 billion segment for you guys, growing pretty fast. What end markets do you serve? And what are these end markets growing at?

Yes. Thanks for bringing up the question about peripheral and sort of what is it. Because I think it's unique in that companies define peripheral in different ways. It's not like a consistent definition like maybe interventional cardiology would be. And so the way we look at peripheral is really in 3 key focus areas: because it's easy to get distracted in peripheral. And by the way, peripheral came from just outside the heart, sort of peripheral to the heart. And so that's a lot of geography that's a lot of highways of arteries and veins to cover everything from a head to the toes outside the heart. So what we look at is staying really, really focused in 3 areas. The first area is just very broadly arterial. And it's a focus primarily in peripheral artery disease, so blockages in the leg. And that's about maybe half of the market, growing sort of mid-single digits-ish. And it's been a big driver of growth for PI at Boston Scientific, specifically with our drug-eluting portfolio being the only company with a contemporary drug-eluting stent and drug-coated balloon. And so that's broken up above the knee and below the knee, so even sort of further defined within PAD. The second area is Interventional Oncology. And this is an area where we serve the interventional radiologists in a whole variety of cancer treatments and other disease states that the radiologist treats. That's maybe about 1/3 of the market. That's about a high single-digit grower. And the biggest drivers of growth there is Y-90, our TheraSphere product. And then an ablation product we have called ICEfx, which is an ablation product used primarily for renal cell carcinoma, kidney cancer and other applications. And then, of course, there's VENOUS within peripheral for Boston Scientific. That's maybe 20%-ish or so. It's been a very strong grower as a market category for Boston Scientific as well over time. And the biggest driver of growth for us there has been our Varithena product to treat superficial venous insufficiency. So a lot of disease states in peripheral, and we could probably spend the whole time defining all of them, but I'm sure you want to get to other questions.

No, this is a helpful overview. If I just based on those numbers you gave, Jeff, arterial mid-singles, interventional high singles, VENOUS are growing fast. The [indiscernible] is perhaps maybe 7-ish in high singles. Clearly, you guys have grown well above market over the last -- consistently, I would say, over the last 4 or 5 years. What's driven that above market growth? Is that market share gain, if it is market share, who do you compete with in the space?

Yes. Well, you know our mantra at Boston Scientific. Our goal is to grow faster than the market and grow operating income faster than sales. And we've been very fortunate to do that in peripheral for really a lot of reasons. I mean I think one is organic R&D portfolio, just our R&D engine has been very productive over the past handful of years. In fact, we launched over a dozen products during COVID. So we've invested a lot, and we've got a really good return on that investment. I think second is globalization. We spent a lot of time looking at geographic expansion. China has obviously been a big focus for us. We've grown a lot in China. And the rest of the emerging markets has been a strong grower for us. And we've done some market development as well early on in venous and interventional oncology. So I think sort of the basics of organic investments that have paid off handsomely, geographic expansion and then, of course, M&A. And we've done some very good M&A that's allowed us to sort of expand into some close adjacencies and bring our portfolio to more customers and really expand our portfolio under the sort of category leadership umbrella. And that's given us the benefits of scale and really some good pull-through. That's helped us grow quite a bit.

Understood. A couple of macro questions before we dive into the segments, right? I was just looking at some of the numbers back in the depth of the pandemic. I mean this segment did remarkably well, right? It was barely down. Other categories were down well in the double digits. What differentiates PI? Like why is the segment so resilient, if you will?

Yes, it is quite a resilient segment. And the good news is I'm a terrible forecaster because I thought PI was going to do a lot worse in the height of the pandemic than it did. So I'm proud to say I was wrong on that forecast. And the reason it really starts with just -- it's a favorable mix of high acuity procedures. Cancer care is a great example. The interventional radiologists really stepped to the fore in the middle of the pandemic and provided treatment options for patients where other options were really suboptimal for example, radiation therapy and going into the hospital every day for a month for radiation treatment versus coming in for a single, sometimes same-day procedure in and out was much more efficient and patients preferred it. So that's just a great example of the efficiency of some of the procedures in PI that really was a tailwind for the business during the pandemic. And then the site of care, I think, was another really good reason. We have a good number of our procedures that are done outside of the hospital for PAD and other procedures. So that was another tailwind where patients needed to have a procedure done and the doctors were able to handle it outside of the hospital really efficiently and safely. So that was a nice benefit for us. BTG went organic in 2020, August, I believe it was. So that was a really nice tailwind of growth. That business has done extremely well for us. So that helped. And then I mentioned product launches, drug-eluting and many product launches just really helped us to pull through some products and take some share and expand our footprint. So it all came together in a really nice story. And in fact, I think you saw the Q3 results just last quarter. It was our first quarter where we eclipsed $500 million. So we've got a $2 billion run rate with double-digit growth. So we obviously aim to achieve highly, but there's a lot of good tailwinds in this business.

And just given how the business performed during the depth of the pandemic, Jeff, should the same hold true if there is a recession how resilient as a segment versus other categories, if you will?

It's proven to be quite resilient. So I'm confident that it will continue to be. So I think health care in general tends to be a bit more recession-proof. These procedures, while they may be called elective, that doesn't mean that you just can't do them. You can maybe put them off a little bit. But in general, the procedures in peripheral will need to get done. And a lot of them are quite emergent, especially like with cancer care and some of the procedures like even in PAD, where patients can be in extreme pain and have really lifestyle limiting issues that sort of encourage them to get in. So I'm confident if there is a recession that this business will remain pretty robust.

And that sort of maybe ties into this next question on reimbursement. Is there any out-of-pocket burden here for patients? And I know this segment, it's given the ASC exposure, perhaps outpatient is more important. Any reimbursement changes, recent changes that we need to be aware of for fiscal '23?

I would say that from a reimbursement perspective, nothing major. I'd sun that up at a high level to be a slight positive, especially in outside the hospital segment with overall reimbursement going up sort of low single digits. Hospital same way. It sort of depends on what procedures you're talking about. But to sum it up, it's a slight positive. The only headwind, I guess, could be Eluvia, which we had the NTAP that went away October 1 of 2022. That was for hospital inpatient, which is a pretty small segment relative to the hospital outpatient. But that anniversary October 1. That would be the only sort of potential headwind in 2023.

That's helpful, Jeff. And maybe at the last macro question before we dive into the segment. Any sense on what percentage of these procedures are ASC within PI versus inpatient?

Yes. Broadly across the enterprise at BSC, it's probably about 2/3 of our procedures happen in the outpatient setting, so hospital outpatient. And then -- and so that's the majority sort of are in the hospital outpatient. When we look at outside the hospital, it's a relatively small percentage. Hard to guess exactly because the data isn't as robust, but maybe 20% or even less. So I think that it's a trend that we've embraced and has actually helped our growth quite a bit.

Understood. And then maybe now diving into other segments, and maybe Cat can chime. And Jeff mentioned Eluvia. It's been a key driver on the arterial side. How large is Eluvia? Like do you have any single product, which has been a key driver within arterial? Or maybe give us an overview of some of the key products you have within that segment?

Yes. No. Thanks so much, and I appreciate the opportunity to be here with you guys. So in arterial, our growth driver has been our drug-eluting portfolio. So that's made up of 2 products: Eluvia, which we've talked about a bit; and Ranger, which is our drug-coated balloon. So Eluvia, our drug-eluting stent; and Ranger, our drug-coated balloon. And I think what really differentiates Boston Scientific is we're the only company in the peripheral space that has both a drug-eluting stent and a drug-coated balloon, and that really puts us in a unique position. Because what it's allowed us to do is take the #1 position in the SFA. So the vessel bed that these products are approved in, we have the #1 position in the United States. And it's been a really exciting journey for us because this is built off of not just great technology, but also the strength of the clinical data that we've brought to bear. Level 1 evidence, randomized clinical trials, comparative effectiveness data demonstrating Eluvia with superior to Zilver PTX, which is the only other DES on the market. And then also showing that we were superior to bare metal stents, both of those getting published in the Lancet and then in circulation recently, which are really highly valued publications by the medical community. And then with Ranger, again, demonstrating comparative effectiveness data that you can get similar results to impact with half the drug dose. So it's been just a really great story for us. It's really resonated in the market.

Understood. Since you brought up those 2 products, let's start with Eluvia, how big is this product for you and how penetrated is this market, right? When you look at the about the knee, do you have further opportunity to penetrate the market? Or are we now at a point where it's all about share gains, talk about drivers?

Yes. No, it's a great question. So last year, I know we said that we were going to do north of $150 million in drug-eluting revenue, and we well exceeded that number. And I think we're continuing to grow in this segment. So I'm really proud of what the team has been able to accomplish there. And to your question around, is this just market share taking, I would say, no. We know that there are a lot of bare metal stents that continue to be used. We know that there are a lot of plain balloon angioplasty that continues to be performed in this segment. There continues to be a lot of room for both of these technologies to continue to grow. And candidly, we continue to launch in different geographies. And so that continues to propel our growth. The one other thing I'll mention is we just launched our longest length Eluvia stents. So now not only do we have the best drug-eluting stent on the market, but we also have the longest drug-eluding stent on the market, which as you know, physicians really value.

That longest length be -- if you don't mind, I thought when it comes to peripheral, there is always a risk of fracture, right? I mean, these are [ tough ] vessels, pretty long. Is there any risk now as the length extends? Or why do physicians appreciate the longer length?

Yes. Oftentimes, what happens is that the issues with restenosis happen at stent overlap zones. And so that's one of the reasons why physicians like to use a longer stent, so that they have fewer overlaps.

Got you. And any sense in how the segment that market? Like how many overlaps there are? What percentage of the market can this longer stent apply? Does it have a premium pricing, assuming it does?

Yes. We did launch it at a premium price. And I think it's -- we don't have a per procedure data in the way that you're describing. We haven't disclosed some of that data. But what I would say is what's really impressive about Eluvia is it really takes lesion length out of the equation. Because what we showed in the IMPERIAL trial is whether you had a long lesion or a short lesion, you were able to get similar results in terms of patency, which is very unusual in the peripheral space. Usually, the longer the lesion, the worse the patency rates are over time. And what we showed with IMPERIAL is that Eluvia really took that out of the mix. You really got phenomenal long lesion length results with Eluvia.

Got you. And then you also brought up DCBs. I feel like that market, we went through the ups and downs. Are we passed all of those meta analysis and the questions that raised on mortality? Are we past -- and is this market back to double-digit growth at this point?

I'd say that while we passed through a lot of the questions around paclitaxel, there are still pockets of physicians who have questions around paclitaxel. So I think as we continue to get more data out in the marketplace around the safety of paclitaxel coated and eluting devices, I think that there is opportunity to continue to grow the market. And that's where I look at that bare metal stent opportunity and the plain balloon angioplasty opportunity. I think we continue to have a lot of room to grow.

Understood. What does Ranger set position in the market at this point? Is this now like #1 or #2? Or any way to quantify what this opportunity is?

Yes. So we don't break out Eluvia and Ranger separately. But what I can tell you is it's really exceeded all of our expectations. Ranger has taken the #1 position in Japan by quite a broad margin. We also have just a very strong presence with Eluvia in Japan. We've done really well in that market. And what I'm excited about is this portfolio that we have, the drug-eluting stent and the drug-coated balloon, they really appear to be working well together.

Understood. And so that fiscal '21 exceeding $150 million, so that was both DES and Ranger, correct?

Yes.

Got you. And just taking to arterial. I think you've recently discontinued the BTK program. Was that because of lack of clinical efficacy? Or can you talk about the go-no-go edition there?

Yes, sure. So that was our SAVAL program. And when you look at the data that we presented at CIRSE, what you see is we did a randomized trial, SAVAL, which is a drug-eluting stent for below-the-knee lesions versus PTA. And what you saw was a really great patency rate in the SAVAL arm, but the PTA arm did better than expected. And so we weren't able to hit our primary endpoint of superiority in terms of efficacy versus the control arm. And the positive message is that back to your earlier question about Katsanos, we didn't see any mortality signals or anything like that with paclitaxel. However, because we weren't able to meet the primary endpoint, we did close down that program.

Got you.

I wouldn't say maybe really quickly, this continues to be an enormous unmet need for patients. Physicians are really looking for more and better solutions below the knee. And so this is an area we're going to continue to invest in.

As an arm, is there a stent opportunity? Or what kind of options do BTK patients have?

Yes. So today, really, the only approved therapies are balloon angioplasty and an atherectomy. And when you look at the outcomes that these patients have, they're just not as robust as people would like in very sick patients. And so we're making investments, both internal and external in this space.

Understood. And then maybe 1 other product you guys have highlighted on recent calls has been the EKOS product. I think that came from BTT. How does this EKOS product fit in within your portfolio? And -- and is there any reimbursement update or perhaps indication expansion that could drive EKOS?

Sure. So EKOS is in our venous portfolio. It's a clot management product. And as you know, clot management, that segment has been a very competitive segment over the last few years. I'm really excited because we were launching a new EKOS catheter, EKOS Plus, which is the first iteration we've had in this space in quite some time. And so it's an opportunity for us to refresh the portfolio, new console, new catheter and get more excitement about EKOS. It's still a very widely used technology. And one of the big investments we're making in this space is around clinical data. We're running the -- one of the largest clinical data sets in this space with a trial called HI-PEITHO comparing EKOS to standard of care for PE patients because today, only 1 in 10 patients with PE gets treated with through an interventional approach, 9 out of 10 don't. And rather than focusing on this very small portion of the market that is actually getting treatment, we're looking to expand the market dramatically by doing the type of clinical data, bringing the type of clinical data that we need to drive the market growth long-term.

And PE, just for reference, that is pulmonary embolism, correct?

Yes. Pulmonary embolism. Yes, exactly.

I know it's a lot of highways, I mean, outside the heart. How -- I'm assuming given you guys were running a trial here, the opportunity here could be substantial. Any sense and if this trial has its end coin, when are we expecting a data readout and what the opportunity could be?

Yes. So it won't read out for until the clinical trial is completely enrolled, and we don't anticipate that to be in 2023. But what I would say is the endpoint is rather short. It's only a 30-day endpoint. So after we complete enrollment in the trial, the data will be available reasonably soon thereafter. .

And how big is this opportunity for, in general, the PE opportunity?

Yes. So if you think about the PE market of being, call it, a $400 million market today and only 1 in 10 patients gets treatment, then that gives you a feel for the total TAM of the market.

That's helpful. And then, Jeff, I got one for you. When you look at this product suite rate within PI, are there any obvious gaps for Boston that you feel like you need to fill in PI?

Well, so we're always looking to fill out the portfolio more, I think. We joke that it's medtech 101, which is keeping the pipeline fresh and having new product launches. And as we talked about, it's such a broad segment that we have to be very, very, very focused. So I think job one is to keep the current pipeline fresh with iterations and expanding into sort of the close adjacencies. Probably the biggest area is what Cat talked about, which is critical ischemia or the below-the-knee segment. The disease state is horrible. It's very, very challenging for patients and the unmet needs are probably the greatest in all of PI. So we are convicted to find the right innovation, and we talked about the drug-eluting adoption in peripheral being so low. I mean if you contrast it to interventional cardiology, where 95-plus percent of patients get a drug-eluting stent and soon drug-coated balloon, the adoption in peripheral is only like 15% or 20%. So we think there are more ways to innovate in drug-eluting and to help patients with just a more durable therapy. And then there's a lot of cancer out there. Well, I'm sure we'll talk about that, but there are many, many solid tumors that could be treated by interventional radiologists that are not being treated today. And that's a key sort of unmet need as well.

And just you brought up a couple of really interesting points, Jeff, on CLI and below-the-knee, stents are not working, atherectomy is not working. Balloons don't work. Do we need a new technology? And is that technology even available in the market?

Yes. So nothing has worked. You're right. There have been 4 large-scale randomized drug-coated balloon trials that have failed to show efficacy. And so it really is a challenging disease state, and it is different than coronary arteries and arteries above the knee. The disease process is different, and I think it will require new innovation. And so we are looking at it from a fresh perspective and working closely with FDA as well as our clinical advisers and our innovators and researchers within Boston Scientific to try and come up with a new approach. And so it will take some time, but we think this is a really large segment and a huge unmet need. And the right innovation, I think, could be a huge opportunity.

Understood. And just digging on to this product portfolio. I know you guys did a deal yesterday, I think on the endoscopy side. I'm curious, Jeff, like how are deals sourced for Boston? Is this that driven by business units? And curiosity, one of your peers from endoscopy or other segments comes up with an idea [ how the ] segments compete for capital within Boston.

Yes. We do a lot of thumb wrestling across the executive committee table. But it is business plan. And so perhaps there was a time where it was more centralized. But I think we're very empowered at Boston Scientific. And so Cat and I and others, we spend a lot of our time looking at opportunities. We sort of pride ourselves on keeping an open mind and looking at everything so that we don't miss out on any opportunities. And we look at both adjacencies as well as sort of new opportunities to move into. And we have a very robust process. So nothing gets to the Executive Committee table until it goes through a very rigorous process within the business unit. As we talked about how big and sort of fragmented peripheral is, it takes us a long time just to get to the 1 thing that we then want to pitch to Mike and the rest of the Executive Committee. And so that's within the business unit. And that across the enterprise, we have a very robust process to bake off opportunities both strategically and financially. And then, of course, a deal is only as good as the quality of the integration and what you can do with it once it's part of the BSC family. And so we go through sort of an exhaustive process to make sure that we turn over every stone, so there are no surprises and that we can appropriately integrate it to keep product quality and bringing into our manufacturing network. So I think we've built some pretty strong muscle and it's definitely a part of our formula, which is both organic growth as well as bringing in inorganic opportunities to fuel the growth even further.

Understood. And then one more sort of big picture question before we go to -- move into [indiscernible]. Anything on -- I know we touched on reimbursement. But how big is PI for you guys in China? Anything on the [ EBP ] front we need to be aware of?

I can jump in, Jeff. Yes. Just broadly in China, the diversification of that business is actually quite similar to Boston Scientific overall. Maybe a little less on serum and Neuromod, but broadly very similar. And just as far as EBP goes, and I'll turn it back to Jeff to give any more context. We've been having success in participating specifically in the drug-eluting stent tender, the balloon tender because it allows us to expand our market access in China, which is really critical and important. And so we've found that opportunistically participating in [ EBP ] has been beneficial for us, maybe a little bit because of our size being bit smaller than some of our other peers, but we found it to be good. I don't know, Jeff, if there's anything you would add.

I think that's great. I'd also just touch on the fact that PI is so fragmented, as I mentioned. We have over 4,000 SKUs within peripheral. And so there is no really, really large category, like coronary drug-eluting stents or something. And so therefore, because PI is made up of a lot of small things that add up to a large number, we think that sort of product and disease state diversification mitigates any sort of big impact from something like EBP.

Understood. And then I guess switching gears now to on the oncology side. What tumors are you treating right now, Jeff? Is this mostly liver cancer? And I think you did mention opportunity to expand to other tumors? So are you running any clinical trials?

Yes. So just broadly speaking, just to frame up the size of the oncology space. So in the U.S., there are 700,000 deaths a year from cardiovascular disease. And there -- that's the #1 cause of death in the U.S. There are 600,000 deaths from cancer. That's the #2 cause of death in the U.S. So not only is that awful for patients, that's a huge financial burden to the health care system. So we see that as an opportunity to bring innovation to bear to treat more cancer. So to answer your question specifically, for TheraSphere right now, we're very focused on the liver. And liver cancer is a very complex disease state because there's early stage and late stage. There's primary liver cancer and metastatic liver cancer. So you can't just say liver cancer. You have to sort of double click on it and then expand within the multiple type of cancers, and that's what we're trying to do right now. So we are FDA approved for primary liver cancer. TheraSphere is the only product that's approved for primary liver cancer in the United States. And we aspire to move into metastatic colorectal liver cancer. That's where the cancer starts in the colon and then metastasizes to the liver. We announced our EPOCH trial. And so that's the goal of working collaboratively with FDA to get on label for metastatic liver cancer. And then we're looking at expanding geographically. So we're running a trial right now called the Mandarin trial. That's to get into China. China has over half the world's primary liver cancer. So we see this as not only a great way to help patients with an efficient and effective therapy, but also a really big business opportunity to geographically expand for TheraSphere. And then we're looking at new cancers. And so we think about it as just any solid tumor that an interventional radiologist can access from a blood vessel is a target for TheraSphere. And we're looking at a trial called the Frontier trial, which is for brain cancer, specifically recurrent glioblastoma. And just like with many cancers, brain cancer is an awful diagnosis. But there are many types of brain cancer, sort of initial diagnosis and recurrent and then different types of tumors. And so we hope to expand into that disease state as well with the current TheraSphere. So one of the nice things of expanding into new solid tumors is the whole R&D process is much more efficient because the product exists. You know how to manufacture it. And so the technical risk is virtually nonexistent. So it's really about executing the clinical trial and then getting on label with FDA.

Any timeline for these trials, Jeff, on the metastatic colorectal cancer? I thought that trial, that had been going on for a while, right? Or when are we expecting the headline results?

Yes. So the results have been published and presented about a year ago. It was published in the Lancet GI, I think. It was presented at Congress in Europe called CIRSE last 2 Septembers ago. And we're working collaboratively with FDA right now to get the indication expansion. And so that's been a process, and so that will take a bit of time. So that one is potentially more near-term, whereas something like brain cancer is long-term because you have to start with the first human use trial. The Frontier trial, I believe, is like 20 patients. Then we have to show that it's safe and then go into the Phase II and then Phase III trial. So it's a bit of a journey. But I think both clinicians, patients and also, importantly, FDA sees how few options there are for patients. And so I think to the extent that it could go quickly, this is one where I feel like all the stakeholders are aligned.

This metastatic colorectal cancer, is that a PMA? And if the FDA does approve this, what does it mean from a market expansion, TAM expansion for Boston?

Well, I think first and foremost, we have positive data, which is unique in the Y-90 field. And so it helps from a differentiation standpoint and really puts Y-90 and TheraSphere specifically more on the map with medical oncologists and then the interventional radiologists. A lot of these patients come to a process in the hospital called the tumor board, where multi specialties come together and collaborate to determine what's best for the patient. So having such strong data sets for TheraSphere really makes it a much more compelling option at the tumor ward for the interventional radiologists. And then being on label just sort of opens up the opportunity with interventional radiologists and patients to pursue it as more of an earlier option, whereas in the past, I think Y-90 and TheraSphere was reserved for a later-stage option. So we're sort of climbing up the ladder, if you will, of treatment options for patients. And like I said before, it's such an efficient procedure. Patients can get in and out of the hospital same day, many times with a single treatment rather than maybe chemotherapy or radiation therapy that's quite burdensome in terms of time and side effects.

Sorry. Once we get the approval, Jeff, do we need reimbursement pathway to be set for MCRC?

No, reimbursement is established and in place for Y-90. So it goes right into the current reimbursement scheme that's in place today. And it's a strong reimbursement setup. So that's a nice part of it.

And in terms of market opportunity, how many MCRCs can you address with an approval in MCRC?

Jeff, we've said it's around 30,000 incidents rate in the U.S. And we do have MCRC outside the U.S. in varied geographies, Vijay, but it does open up a newer market.

Understood. And then, Lauren, a couple for you here. I think your guidance here at 9% for fiscal '22, that implies 8% for Q4. Just on the macro here, what have you guys said on utilization, Europe, China, block downs, et cetera, anything from a big picture perspective we should be aware of?

No. So that growth rate in Q4 implies right around 8%. It is a tougher comp going from Q3 to Q4. So the range of the 7% to 9%, 8% at the midpoint seems very reasonable, and we haven't provided any differing macro environment perspective than that.

And the Swiss headlines on China lockdowns, is that -- does Boston have a [indiscernible]?

Yes. So I mean, China's experienced lockdowns kind of throughout the year. If you look at our Q2 performance, we grew about 9%. Q3, we grew about 36% and are forecasting to grow double digits for the full year.

Understood. And then just 1, given where we are. Anything on FX up there, thoughts on FX and pricing environment for fiscal '23?

Sure. So for FX, we have seen more headwinds than historically just related to the strength of the dollar and frankly, some nice growth in countries where we don't hedge currency just because it's too expensive. So net-net, that's been about $0.06 of a headwind to EPS. As you know, our goal is 0 and historically has been 0. However, just in light of all those items, we have seen headwinds. If you look towards next year, we do anticipate slightly unfavorable FX versus '22, and that's largely due to the strong growth in those markets where we don't hedge currencies. As it pertains to pricing, we've been really proud of the strides we've made in improving the price headwind over the last few years. We used to see around a 3% headwind to sales kind of pre-COVID. We continue to invest in innovative new products where we can really diversify the portfolio away from more of our price-sensitive markets and enter into new adjacent markets where price isn't as much of a pressure item. And so as we look forward, we've talked about sort of more low single-digit declines right now. And maybe there is a world where we can get back to flat, which would be the first time ever, but certainly continue to see improvement in price and less of a headwind than it has been historically.

Got you. And just on FX, sorry, when you said slightly unfavorable versus fiscal '22, is that another $0.06 plus headwinds in that '23?

So that with -- if you take $0.06 in 2022 as a headwind, you would add a little bit to it in '23. So you've already got the $0.06 in your baseline. And so the slightly unfavorable would be whatever you view as slightly to that $0.06.

Understood. Then maybe in the last minute here, Jeff, Cat, maybe for you, Lauren, any key products we should be aware of for next year, which would be new or something that the Street should be focused on?

I'll turn it over to team PI, yes.

Cat, you go first, then I'll chime in.

Sure. So one thing that we haven't talked about is our Wolf thrombectomy system that will be going through early market release next year. And we're really excited about this product. It's a very unique mechanism of action, really new in the thrombectomy space. We talked about how big and how fast growing that market is. So we're excited to bring new technology, new innovation to this space. And maybe, Jeff, I'll turn it over to you.

Yes. I'll just touch on broad category called embolization. It's about a $900 million market. We did an acquisition last year called Obsidio in that space. And then we have an organic product called Embold, which is a coil. And both of those together, we think, could be leading products in the embolization space. And so that will be organic growth to PI. And so we're super excited about that underneath the Interventional Oncology umbrella.

Great. And Lauren, from a corporate perspective, anything that you would highlight?

I think ongoing momentum, more durable procedural volume, consistent growth, our diversification, our globalization, I think that all culminates to another strong outlook for 2023.

Fantastic. I think with that, we're at the end of time. Jeff, Cat and Lauren, thank you for the time this morning. I learned a lot about PI. Excited about Wolf. I should focus more maybe for other conversations.

Next time. Next time. Thanks for having us.

Thanks so much, Vijay.

Thank you, Vijay.

Take care.