Medtronic plc (MDT) Earnings Call Transcript & Summary

Okay. I think we're going to -- it's time to get started. So hello, everyone. I'm Ryan Weispfenning, Vice President and Head of Investor Relations at Medtronic. Thank you for joining us for our Medtronic General Manager Call Series. Today marks the second episode this calendar year and the fifth since we initiated these in late 2019. We're excited to host the second episode here of our GM Call Series. And we've got a full pipeline of innovative products and ongoing launches that we intend to highlight with these calls and give you an opportunity to hear from and interact with the presidents and general managers who are running these large businesses at Medtronic. For today's event, we're pleased to feature our Neuromodulation business, which is in our Neuroscience portfolio. I'm going to invite each of our Neuromod leaders to turn on their videos one by one in a moment. But for now, I'll introduce them by name and title. You can see their pictures here on the slide. So joining me today is Dave Anderson, President of Neuromodulation; Charlie Covert, who leads Pain Therapies, which addresses spinal cord stimulation, drug infusion for chronic pain and cancer pain and drug infusion for severe spasticity; Anu Codaty, who leads Interventional Pain, which includes RF nerve ablation, balloon kyphoplasty, vertebroplasty and RF ablation; and Krissy Wright, who is serving as the Interim General Manager for Brain Modulation, which includes our Deep Brain Stimulation portfolio. Similar to prior calls, I have some prepared questions for our Neuromodulation management team, and then we'll have plenty of time for questions from the sell-side analysts that cover Medtronic. If we go to the next slide. If you're a sell-side analyst that covers Medtronic and you intend to ask a live question during today's event, please make sure you're connected to the Zoom platform via the link in the invitation you received. [Operator Instructions] And let's go to the next slide. I want to note that on today's call, we could make some comments that may be considered forward-looking statements, and actual results might differ materially from those projected in any forward-looking statement, given risks and uncertainties. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports and other filings that we make with the SEC, and we do not undertake to update any forward-looking statement. I encourage you to go back and read this slide. Further, we'll be discussing certain products and indications... [Audio Gap] Krissy, Anu and Charlie, thanks for joining me today. And Dave, if you could turn on your camera to join us. I'm definitely excited to highlight your business given the increased focus we're seeing on this market and our enhanced competitive position. Before we dive into the business, though, Dave, perhaps you could share how long you've been at Medtronic and what roles you've held prior to this role.

Well, thanks, Ryan. I came to Medtronic 4 years ago to lead our enabling technologies business, and transitioned to my current role as President of Neuromodulation about 18 months ago. I began my career as an engineer, and I've been in med tech really for my whole career, beginning at St. Jude Medical, Abbott, and then smaller start-ups as well.

Great. Thanks for that introduction, Dave. So next, I'm wondering if you could start at a high level with the Neuromodulation business as a whole. I'm sure there's a few in the audience today that are less familiar with this business. So maybe you could share the size of the business, the key markets that we serve and the disease states that we're addressing. And while you're at it, to tack one more on, could you also provide some color on the Neuromod market and its growth today?

Sure. So the Neuromodulation portfolio consists of 3 businesses: Implantable Pain Therapies, which is spinal cord stimulation and targeted drug delivery; Interventional Pain, which includes kyphoplasty, vertebroplasty and ablation; and Brain Modulation, which includes DBS and laser ablation. Last fiscal year, we were at about $1.6 billion in revenue in a COVID-depressed market. As we look forward and we look at post-COVID market growth over the next few years, we see our largest businesses, spinal cord stimulation and Deep Brain Stimulation, being mid- to high single-digit growth. We see Interventional Pain being mid-single-digit growth, but having some fast-growing segments like tumor ablation that's going to grow to double digits. And targeted drug delivery is a low single-digit growth, but it's an important therapy for our patients, it has strategic value for our customers, it's important in the continuum of care.

Great. And I think that the case, as is the case with many therapies at Medtronic, yours are no different that they're very underpenetrated. What are some of the barriers to adoption across your key markets? And when you think about market development, how do you make that decision on whether or not you invest and grow established markets versus allocating resources to enter into new therapies?

Well, as you shared, we treat multiple, debilitating, undertreated diseases such as chronic pain, movement disorders, spasticity, epilepsy, cancer pain. And as you look across them, what's the most common is that our most sizable therapies like spinal cord stimulation, Deep Brain Stimulation, targeted drug delivery, they're later in the care continuum, and they have fragmented care pathways and patient awareness is low. So while that's a headwind to penetration and adoption, we see some of the therapy innovations that we're bringing and have brought, like BrainSense and DBS or closed-loop therapies in spinal cord stimulation, that they're going to provide more compelling value to referrers and clinicians and then ultimately, be able to generate more patient awareness as well. So we're going to unlock that for greater penetration. As we consider established versus new markets, we look at the addressable population. We look at how penetrated they are, how fertile the ground is to penetrate further. And as we look at that from a geographic perspective, Spinal Cord Stimulation for failed back surgery, it's reasonably penetrated in developed geographies, but still very underpenetrated in many geographies. And then you look at new indications like nonsurgical refractory back pain or painful diabetic neuropathy or upper limb and neck. And those are large populations that are just beginning to be served. So significant opportunity for growth in those new indications. As you look at DBS, movement disorders is underpenetrated even in developed geographies. So there's significant opportunity that remains. And then as you look at new diseases that we could treat with neuromodulation and the broader potential of bioelectronic medicine, there's many more disease states that we can effectively treat. And we're assessing that right now, which new disease areas we'll enter with the technologies that we have.

Great. And then I was thinking we could turn a little bit to your technology as well because there's an exciting story here. Can you tell us about neuromodulation's innovation pipeline, and perhaps spend some time talking about some of our recently launched products. And as you do that, how has product innovation played into your strategy to capture market share? And how do you feel about Medtronic's competitive position right now to maintain and expand our share position?

Well, we're certainly in a strong position right now with our recent launches across our portfolio. And our future is even brighter as we have the promise of personalized medicine through the closed-loop therapies that you'll hear more about today from Charlie and Krissy. In spinal cord stimulation, DTM is showing outstanding durable pain relief, that's been evidenced by our recent 12-month RCT publication. We've also brought that market-leading platform capability to the recharge-free segment with Vanta. So Spinal Cord Stimulation, stronger than ever before, future's bright with closed loop. In DBS, we now have the only sensing-enabled directional stimulation system in the market, and we're in clinical trials right now on making that closed loop on adapting. As we look ahead, we see smart adaptive therapies in both DBS and SCS being a game changer for outcomes and driving even more share take. So we're gaining share across all our businesses that's driven by our recent product launches, and we see that trend will only strengthen as we have a really robust pipeline behind us.

Great. Thanks for that overview, Dave. And I'll have you join us again at the end for Q&A. But next, I want to take a quick tour through the Neuromod portfolio. Let's turn first to Brain Modulation and Krissy Wright, and I see your camera's on, Krissy. Thanks for joining us today. And first, Krissy, I'm wondering if you could share how long you've been at Medtronic and what roles you've held prior to your current role. And then it would be great for you to have us -- have you walk us through the Brain Mod business in the market, touching on the conditions that we treat, the market size, growth rates and our leading product portfolio, including Percept and SenSight. And then if you could share with us a little bit about the future of DBS with our ADAPT clinical study and closed-loop DBS. So I realize that's a lot of questions, but hoping you can cover some of those things for us today.

Yes. Great. Thanks, Ryan. Really happy to be with the organization today. So as Ryan said, I'm Krissy Wright, and I'm actually currently the CFO for the Neuromodulation and Public Health operating units and was recently named the Interim General Manager for the Brain Mod IOU as Mike Daly is out on a medical leave. So I've been with Medtronic for about 11 years, primarily with roles in finance, both in Corporate Finance as well as with a number of businesses in the RTG and now Neuroscience portfolio, and I had a stint through corporate development as well. Prior to Medtronic, I worked for PricewaterhouseCoopers, first in their audit practice and then in the transaction services organization focused on financial due diligence. So I'll try to tackle your questions, Ryan, one by one. So first, the Deep Brain Stimulation is used primarily to treat movement disorder conditions. And Medtronic has the most approved indications, including Parkinson's disease, essential tremor, dystonia under an HDE, epilepsy as well as OCD under an HDE. We're approved in all major geographies, but as Dave mentioned earlier, into very underpenetrated therapy. And our research tells us that less than 15% of eligible patients in the U.S., less than 10% in Western Europe and only about 1% in China receive DBS therapy today. We estimate our global market to be approximately $700 million across all indications, and we think it's going to be growing high single digits for new implants in the next 5 years. We've invested heavily in the last 5 years to overhaul our overall product portfolio. Last year, we launched Percept with our new INS, including BrainSense and its 3T MRI compatible. And this year, we launched SenSight, our directional lead system, which is the only lead system on the market specifically designed for sensing. Both Percept and SenSight were launched with more than 10 years of research into sensing. Medtronic has been working for decades to understand the brain, and our BrainSense technology had been critical advancement in this pursuit. Percept and its sensing capabilities now offers clinicians a way to monitor patient's brain activity and observe the changes with stimulation and medical therapies. They can use what they see to inform their treatment decisions. We believe strongly that BrainSense is more than just a technological widget. It's a major paradigm shift for us in how we can treat diseases of the brain, starting with how movement disorders such as Parkinson's can be monitored and treated to create a patient-tailored approach. And lastly, with the ADAPT study, we're currently evaluating how brain sensing can be used for adaptive DBS, ADBS, in Parkinson's patient subject, and we look at it to automatically adjust the stimulation in response to fluctuations in each patient's brain activity. And globally, all sites are currently actively screening for enrollment, and we continue to actively recruit more centers.

Great. Great. Thanks for that overview, Krissy. And I'll ask you to join us again in a little bit for Q&A. But next, let's move on to a Anu Codaty. Anu leads our Interventional Pain business. Thanks for joining us today, Anu. I'm wondering if you could share with us how long you've been at Medtronic and the roles you've held prior to your current role. And then tell us about the Interventional Pain business and where you're taking this business. How are you looking at both market expansion as well as strengthening our current offerings?

Good morning, everyone. I'm Anu Codaty. It's a pleasure to be with all of you. I've been in health care for my entire career, 22-plus years. The last 10 of those have been with Medtronic. During my time here, I've held various roles in corporate strategy, business development and product development. Prior to Medtronic, I was with Genentech and Bain & Company. Last year, I took on this role leading the Interventional Pain Integrated OU. When I think about strategy, we really think of it in 3 buckets. First and foremost is innovation-led growth in our core vertebral compression fracture segment; taking share in balloon kyphoplasty, a therapy that we created; advancing clinical and data-enabled innovation in our fast-growing tumor ablation segment; and finally, owning the entire pain care continuum by expanding into the high-growth early intervention segment. One critical way in which we are getting after this strategy is by implementing a portfolio mindset into our commercial teams. Earlier this year, we combined my sales force in Interventional Pain and Charlie Covert's Spinal Cord Stimulation business under 1 sales leader to offer the full portfolio to treat back pain. With integrated sales management, we have brought discipline in offering the full portfolio of products and commercial solutions to pain managers and surgeons through the entire care continuum and across all care settings. This structure was also designed to position ourselves for growth in this early intervention space, which we find very exciting. Right now, we are seeing this in play as we are leveraging Vanta and our interventional portfolio, specifically RF ablation within new accounts. We are seeing our ability to offer pricing and contracting opportunities in all types of service, particularly the lower acuity sites of care. We're seeing very strong growth in Spine Essentials. This is our ASC and office BKP product line. We created this streamlined kit by partnering with physicians to simplify the procedure without compromising on either the quality or the familiarity that they're used to while managing costs. This streamlined kit provides the most commonly treated spine -- provides product for the most commonly treated spine levels with VCF. It includes all the tools you need for a single-level BKP and contains a bone biopsy device in every kit. Further, as part of this overall portfolio strategy, our dedicated ASC sales force is trained on Accurian RF system for nerve tissue ablation, so that when they're going to ASCs, they offer the full portfolio again. Touching upon our early interventions portfolio, we are targeting several chronic pain disease states, which have large underlying patient populations and a very high degree of unmet need. First is lumbar spinal stenosis. This has about 2.5 million patient population, degenerative disk disease with a 3 million addressable patient population and sacroiliac joint dysfunction with 1.5 million patient population. Again, very large patient populations, all following a similar care continuum. And finally, aggregating with pain managers who are our current customers. Ryan, talking about how we are looking at expansion and [Audio Gap] we're really focused in the short term here on protecting our market share with enhancements like faster ablation times. We've also made investments in clinical data. One example is the OPuS One study. This is the largest prospective study on the performance and safety of radio frequency ablation for the treatment of palliative bone metastasis to date. This data demonstrates that OsteoCool provides significant pain relief and improved quality of life in as little as 3 days, and a benefit that is sustained through 12 months as a palliative treatment for patients with bone metastasis. We've made major investments in R&D to support the growth of this important platform as well as in expanding our BKP portfolio. We have the best RFA system, the strongest clinical data and leading market share. We continue to invest in developing the market to increase awareness amongst referring oncologists as well as treaters, and we feel great about our investments in this area again.

Great. Thanks, Anu, and appreciate the overview of the interventional business, which I know doesn't always come up on earnings calls, so it's good to give that overview for investors and analysts. And I'll ask you to join us again for the Q&A session when that comes up here shortly. But next, let's turn to Pain Therapies and Spinal Cord Stimulation. And Charlie, can you please join me? Thanks for turning on your camera. I'm going to start with the same question that I asked Dave, Krissy and Anu. Maybe if you can start with just how long you've been at Medtronic and the roles that you've held. And then give us a bit of perspective on the SCS market, including the size of the market, the growth expectations, which I know a lot of investors and analysts have been asking about. And then share with us how some of our recent product launches like DTM, Intellis and Vanta are making a difference in the market. Charlie, I can't hear you either.

Ryan, you got me now? I apologize for that.

Yes.

Well, thanks for the question. I appreciate the opportunity to connect with the group today. For those of you I haven't met, my name is Charlie Covert. I'm GM for implantable Pain Therapies business. I stepped in as GM in this business back in about 2016. My experience in med device dates back about 20 years with over 15 of those with Medtronic. And prior to my current role leading Pain, I held multiple roles in our Cardiac Surgery and Cardiac Rhythm businesses across strategy, product planning, marketing, business development and sales. And prior to moving over to our Pain business in 2016, led marketing and strategy for our pacemaker business launching Micra, the transcatheter pacemaker, which I'm sure many of you are familiar with, and led product planning for our first Bluetooth-enabled platforms within that Cardiac Rhythm business as well. So I hope that background helps. But let me turn to your questions, Ryan. We've got a lot of ground to cover here. I'll start with the market. In terms of the SCS market, ultimately, as Dave mentioned at the outset, we see it recovering and growing in the mid- to high single digits as we anticipate several new indications for the therapy being approved and adopted. And I'm going to discuss a little bit more about those in just a moment here. But the current environment is a bit more challenging, as you all know, as we've continued to navigate kind of the effect of COVID-19 on a highly elective procedure space. It has not fully recovered to the pre-pandemic levels. And while we see many patients who are already in the later stages of the SCS care pathway, may have been treated and likely caught up since mid-2020, we know that there's still patients out there in the early stages of the care pathway that have been delayed. So we'll be continuing to work through that backlog. Looking ahead, we believe that the core indications for failed back surgery syndrome, or FBSS, and CRPS, or complex regional pain syndrome, will recover in kind of that low single-digit growth range. But we see the expansion of clinical evidence to drive coverage and adoption of SCS for new indications, multiple new indications, including nonsurgical refractory back pain, upper limb and neck chronic pain and painful diabetic neuropathy is really key drivers of growth. And as we've stated also in the past, with an opportunity, we believe, a total addressable market that's over existing double the market revenue today in our current indications. So if these additional indications begin to kind of pull in new patients, we believe this market is going to grow, again, in that mid- to high single-digit range for several years. So I want to switch a little bit to kind of our product launch space after having commented on the market, that's a bit of a longer-term view, but really what excites me now about our business is our current competitive position in a number of our recently launched technologies into the marketplace. I'll start with DTM spinal cord stimulation. This is a proprietary algorithm on our platform, the Intellis rechargeable platform, that has demonstrated superior sustained back relief compared to conventional spinal cord stimulation. And for those of you not familiar with DTM SCS, it's an algorithm that targets multiple signals at multiple anatomical targets. And just recently, in a large multicenter RCT at 12 months, DTM demonstrated superiority, with 84% of patients with chronic back pain treated with DTM SCS reporting greater than 50% pain relief, and that's compared to 51% of patients that were treated with conventional spinal cord stimulation. Those trial results were first announced back last October, but have just recently also been published in a peer-reviewed Journal of Pain Practice. Beyond the evidence, we continue to receive really positive feedback from our clinicians and customers and their patients on DTM SCS, and we are taking share from our competitors in the market, which, again, we're proud of and the progress we've been able to see in the adoption of the therapy here. Moving beyond our rechargeable market into our recharge-free segment of the spinal cord stimulation market. This summer, we just recently launched Vanta, which is our high-performance recharge-free implantable neurostimulator with a device life that can be optimized up to 11 years. Now historically, Medtronic, as you may know, has been a low single-digit player in the recharge-free market, which accounts for about 1/4 of the total spinal cord stimulation market. And we obviously expect Vanta to change that. It offers a battery that lasts nearly twice as long as competitive devices at comparable settings. And Vanta with Intellis provides unmatched MRI access, and this is a key feature for clinicians, as we know that about 4 out of 5 or greater than 80% of patients are going to need an MRI within 5 years in their implant. As for DTM on Vanta, this is a question that comes up often, we're carrying out the DTM principles, multiplex algorithm, coordinating multiple signals at multiple anatomical targets, forwarding to a program we call DTM ENDURANCE. And it's specifically proposed for our recharge-free platform, Vanta. And we're still early in our evidence development for DTM ENDURANCE. But the evidence we have so far is encouraging. It suggests that patients can maintain pain relief and satisfaction while benefiting from a reduction in energy usage, which is really important on a recharge-free platform. And we look forward to sharing more about this in the coming quarters, Ryan.

Yes. Thanks, Charlie. That's exciting. And I was also thinking about your pipeline. I know investors are interested in our next-generation SCS system using closed loop, which uses ECAPS. And I was wondering if you can give us an update on that program as well as the 3 indication expansion trials that you touched on earlier. Maybe you can update us on where those trials stand.

Yes. Sure. Thanks. Well, there's no doubt that this space has advanced considerably in the last several years. But we've not done this in a way, Ryan, that really looks at the body's response. And that's what our next-generation closed-loop technologies will help us do. We look at personalized and real-time response to stimulation. We adjust the therapy as needed. So it's built around ECAPS, which you referenced, which stands for evoked compound action potentials, and this is a measure of neuro response to stimulation. One of the ways I've tried to describe it to others in the past, a simplistic way to think about it would be like an adaptive cruise control feature in your car. You set your speed, or in the case of SCS therapy, a preferred dose, and we automatically maintain and adjust the dose like your car would maintain a safe distance and optimal speed. Yes, we really believe this is going to be a disruptive leap forward in this space, especially considering our unique approach where we expect to deliver contemporary therapy like DTM in a closed-loop fashion. Also, we plan to carry forward the cutting-edge proven technology at the Intellis platform. And as many of you already know, this includes the smallest INS on the market, our overdrive battery technology, SureScan MRI and snapshot objective reporting. So when we put these aspects together, we see our next-generation SCS system is really unmatched in the market. We're tracking, as we've talked about in the past, to an FDA submission here before the end of the calendar year, and we'll be providing more updates on that into the future. On the indication expansion topic, this again, as I outlined at the outset Dave mentioned, this really represents the future growth for this space. And we're in various stages of clinical evidence for each of the 3 emerging indications that we're studying. And I'll make a couple of comments on each of those. For nonsurgical refractory back pain, there are 2 studies underway right now, one in the U.S. and one in Europe. The studies have distinct end points, each is required differently in the respective markets. We anticipate pivotal data available next calendar year, in 2022. Today, nonsurgical back -- refractory back pain is roughly a $110 million market, and we estimate the TAM to be about $1 billion. So it's a significant opportunity for us. Regarding upper limb and neck pain, feasibility study work is currently underway, where we're evaluating the effectiveness of DTM spinal cord stimulation in this population. But we believe that this patient population could really benefit from our next-generation closed-loop therapy as well. You think about it, given the narrower space kind of in the cervical spinal canal, these patients are known to have a higher degree of positional sensitivity, potentially accentuating the benefit that they could receive from a really responsive closed-loop system like the one we're implementing through ECAPS. So one or more studies will follow. But right now, we're currently in feasibility study phase on this work. And then finally, on painful diabetic neuropathy, we're currently planning a study in this patient population with the benefit of our latest therapy advancements. We anticipate beginning enrollment in that study in calendar year '22. It's about a $70 million market we estimate today, and we would put this TAM just shy of about $2 billion.

Okay. Great. Great. Thanks, Charlie. All really big opportunities for Medtronic. And I'll ask you to join me soon for Q&A. But before we do that, I want to circle back to Dave. And so Dave, if you could turn on your camera. And I know these are really exciting times for Medtronic Neuromodulation with a number of successful products in multiple growing markets you're taking share, and you have a very robust pipeline. Just wondering, though, as we close out here, what do you think is most underappreciated or least understood as you think about the future of Neuromodulation?

Thanks, Ryan. I appreciate the opportunity to kind of wrap it with a perspective there. First, while more and more investors are starting to notice, I think many may not fully appreciate the turnaround that this business is undergoing. After years of losing share, we made significant investments in these businesses. And you've heard today about all the technology that we've recently brought to market. And this innovation has transformed us from being a perennial share donor to a business that's growing above market and poised to do so for many years to come with our robust pipeline. So that's, to me -- first and foremost, that's today. Our trajectory has shifted, and we see that accelerating. As we look ahead into the future, I want to highlight what I see is really 2 critical areas to transformation and growth. The first, you've heard about through Charlie and Krissy, and I mentioned it, but personalized medicine that will be achieved through closed-loop therapies. What I want to step back is the foundation to all of that is sensing. It's really difficult to sense brain and spine signals. We're sensing something that's 1 million times smaller than the stimulation therapy that we're delivering. We've been working on it for more than a decade, and now it's available. So as we develop smart, adaptable AI-driven algorithms that leverage that sensing, that understanding, we're truly able to deliver personalized medicine for the first time. Now as you think about that capability and the platforms that we just talked about and you think about different diseases that could be treated, that's the promise of bioelectronic medicine. We're assessing those diseases right now. We look forward to sharing those new treatment opportunities in the future.

Yes. Really exciting stuff there, Dave, and very helpful. Wondering any last comments here before we go to Q&A.

Let's go to Q&A.

Okay. Good. So we'll turn here to Q&A. As we have the Neuromodulation team here today, I ask that you please keep your questions focused on that business. We don't intend to answer broader non-Neuromod questions today, and we're not going to provide any updates today on things like COVID impact on broader Medtronic. So please keep your questions focused on Neuromod. [Operator Instructions] Lastly, please be advised that this Q&A session is being recorded. And with that, I'll pause a moment here to see the hands go up in the queue. And I'll ask Krissy, Anu and Charlie to join Dave and me by turning their cameras back on. Okay. So I'm seeing some hands pop up. [Operator Instructions] And so the first question here will go to Matt Miksic at Credit Suisse. Matt?

So I'll stick to just one. The comments you made on the SCS market, I appreciate the color on where it can go long term and where it is today. I'm just wondering if you could maybe provide a little more cadence as to how we'd get there with these new indications? Is it sort of exiting '22 and '23 as these indications build, would you anticipate? Or maybe map out some -- just the trajectory of growth would be super helpful.

Thanks, Matt. Charlie, why don't you take that?

Yes, I'll start with that. Matt, thanks for the question. I think, first, as I talked about, let's kind of capture all 3 of them maybe in the context to your question. I think first, the timing of our -- of the 3, I think the timing of data around nonsurgical refractory back pain will be earliest in our cadence, Matt. So that opportunity that I talked about in the range of about $1 billion I think it begins to unfold, right, as we release some of that data in calendar year '22. We're going to be initiating a study then around painful diabetic neuropathy in that time frame as well, probably closer to midyear next year to get initiated in that space. And then over the course of the enrollment then, the follow-up, we would expect in the next couple of years that opportunity to begin to unfold. And then finally, as we bring our ECAPS-enabled system to market and we begin to think about the application of that technology for a population like upper limb and neck, we will start to build evidence both around the indication but also that technology. So I think you're going to see a real steady cadence, I would say, over the next 4 to 6 years, the technology beginning next year against each of these indication spaces. I think the only other comment I'll make here is that this is going to require more than clinical evidence, right? So we've got a robust effort underway that we'll be initiating around ensuring that we can bring payers along on the ride for some of these indications that aren't currently covered as well. So I hope that helps answer the question.

Yes. Thanks, Matt. Next, let's go to the line of Danielle Antalffy at SVB Leerink. Danielle?

Krissy, I think this question is probably for you in the Deep Brain Stimulation market here. You mentioned the very low penetration rates. And I guess I'm curious whether you think we're at an inflection or what it's going to take to get us to an inflection from a penetration perspective? So getting at is it technology? And it sounds like you guys have made a lot of advances there. Is that enough? Do we need to -- need more clinical data? What is the big barrier to adoption? What keeps us from 15% penetration in the U.S. to whatever it should be, 30%, 50%, pick a number.

Yes. Thanks for the question, Danielle. So actually, it's a combination of all of them, right? I do think technology, especially Medtronic's launch of technology with sensing capabilities, helps to personalize the medicine for our patients. And we have a number of clinical studies which show that when patients get DBS therapy, they improve, right? So it is not a question of efficacy from the DBS therapy itself. And really, as we think about the underpenetration, it comes down to a couple just large barriers in the marketplace. One is patient acceptance. They need to get brain surgery. So we're working on ways to innovate on the procedure, make it more palatable for patients, looking at a sleep DBS as an example; as well as the referral pathway can be a little bit of a headwind for us as well and working on ways to connect the neurosurgeons with the neurologists in the communities to be able to provide education for the availability of DBS as well as just community outreach. So it's going to be a combination of all of those areas in order for us to really break down the barriers to increasing our penetration overall.

Thanks, Danielle. Next, let's go to the line of Matt Taylor at UBS. Matt?

You guys can hear me okay?

I can.

Great. So I did have a question about the new indications. I was wondering, given you had your competitor, Nevro, come out with some data around PDN, for example, do you think Medtronic could actually see a pickup in its own PDN implants before you have data as the broader acceptance in the market driving that? Or do you think most of that will accrue to Nevro?

Go for it, Charlie. Can you comment on that, please?

Yes, I'll go for it. Thanks, Matt. Yes, I think naturally, I mean if you think about the application of our therapies against the existing indication spaces today, we do see that happens in some context. Look at nonsurgical refractory back pain today, Matt. I mean this is a -- it's not labeled, it's not indicated right now, but it gets -- it does get used. And there are times where that gets challenged by payers and other times where our clinicians are successful and kind of demonstrate the case for these patients. So I think we're going to see that, too, with painful diabetic neuropathy. But clearly, until we've got an indicated use or a label to prove use for this, we won't be out there promoting that to the marketplace, but there may be some natural tendency to use it for that cause.

Next, let's go to the line of Chris Pasquale at Guggenheim. Chris?

Can you hear me okay?

We can.

So a question for Charlie, and maybe Dave can chime in as well. Curious why you think the SCS market has been more impacted by COVID than some other non-emergent procedure categories. And what gives you confidence that the SCS market can be a mid- to high single-digit grower going forward? It was a much faster growth market than that back in 2017 and '18, and it actually declined in '19. So the trajectory pre-COVID was not really clear. So just some thoughts on that would be helpful.

I'll start, Charlie, just kind of sharing about COVID impact, and then maybe Charlie can share a more forward-looking view on SCS. As we look at our businesses and COVID impact, we looked, for example, specifically at Delta this last quarter, but you can look at past waves, SCS and DBS were actually both very impacted. Our businesses like interventional, balloon kyphoplasty, those are less elective, those tended to do much better. So just to be clear, I do think SCS and DBS are examples of among the most elective, among the, let's say, most quickly deferred. And so we've seen that in the Delta variant as well. So I just want to put it in that category. I don't think it's just DBS -- or just SCS, but we've certainly seen it in DBS as well. But Charlie, you want to speak to maybe the post-COVID forward-looking view?

Yes. I'll just kind of summarize it by saying reiterating a point I made earlier about the -- just the sheer size of the opportunity, first, I mean, being twice the existing revenue market that exists today, I think, is going to be a motivator for pulling these patients forward for this therapy. The fact of the matter is these patients with some of these conditions that we've kind of highlighted that are not being treated today continue to go untreated in this space without options. And we believe that will be a significant driver for penetration of spinal cord stimulation in the future. And then as you know, too, this market is very dynamic, the chronic pain space. Anu talked about a number of the emerging therapies too within -- in her area as well. And we believe that bringing that new innovation, that new technology to these growth opportunities will motivate even greater interest in this therapy. So I really -- I'm optimistic about the opportunity, the sheer size and then also the technology we can bring to these markets.

Thanks, Chris. Next, let's go to the line of Larry Biegelsen at Wells Fargo. Larry?

Ryan, you can hear me?

We can.

Good. So I wanted to ask a question for Dave or Krissy on epilepsy. Curious to know how big that indication is for you guys today? What's next in the pipeline? And how are you thinking about applying the closed-loop technology there?

Sure. I'll start, and then Krissy, please add some specifics on what I'd share. For starters, we are looking at epilepsy from a disease perspective and see significant opportunity. Obviously, we have 2 later-stage therapies today with DBS and laser ablation. But again, a very undertreated, very debilitating disease state. I'd say, overall, from a broad perspective, we're looking at how can we treat more effectively and how can we treat earlier in the care continuum, too. So Krissy, do you want to share some of your kind of strategic point of view on it?

Yes. Thanks, Dave. And as you mentioned, we are looking at doing a deep dive in our strategy overall, including adding some additional products to our portfolio. And as we see it right now, and you're probably familiar with our Visualase transaction we did a number of years ago, also focused on laser ablation for epilepsy. And with the indication we got in DBS as well, we continue to see growth for that therapy as well. But because these patients are treated through a number of physicians and get passed along the way, it's a pretty complicated care continuum. We feel that it's really important for us to have a number of options for them as they work through their very complicated medical journey.

Thanks, Larry. Next. [Operator Instructions] I see top of the queue here, Danielle Antalffy. Danielle, you have another question?

I do. Thanks, Ryan. Sorry to be greedy here, guys.

No problem.

But just a question for Anu on the Interventional Pain space. This is a market I don't actually work as well as the other 2. So would love to hear a little bit more color on the competitive landscape here and how that's evolving. And then it's a multipart question, I apologize. How much overlap is there in Interventional Pain versus something like spinal cord stim, for example?

Thank you, Danielle. Let me cover that in -- by therapy. In the vertebral compression fracture space, our primary competition, this is a highly competitive space, primary competitors are Stryker, J&J, Merit Medical. We still have the leading market share in the space. Stryker is our strongest competitor here. Again, we believe that with our innovation-driven portfolio, we have significantly increased our investment in R&D that we will continue to be the leader in the space taking share. And historically, we've donated share to Stryker. We have reversed that trend, and we see that trajectory changing. On the tumor ablation space, Merit Medical is really the key player there that is our competitor. And we still have the leading market share there. We expect -- again, it's an attractive, fast-growing market. We expect other entrants. But right now, that's Merit Medical there. In terms of your second question with -- in terms of overlap with Charlie Covert's business, we see overlap in 2 key areas. One, pain physicians are -- we see an increase in the number of pain physicians wanting to do kyphoplasty in the office setting. So we see an overlap there. There's also overlap in the surgeons in between both of these businesses, and that's what we're trying to leverage there.

Thanks, Danielle. Next, let's go to the line of Steve Lichtman at Oppenheimer. Steve?

Ryan, can you here me?

We can.

Okay. Great. Both on the SCS and the DBS sides of the business, you talked underpenetration worldwide. Obviously, Neuromodulation is much heavier revenue mix in the U.S. and the rest of Medtronic. Can you -- can international be an outside driver versus U.S. over the next 3 to 5 years in the Neuromod business? If so, how? And if not, why not?

Thanks, Steve. I'll start, and then ask Charlie and Krissy to share more specifics. But the simple answer is, absolutely. It's an area that we're really strengthening our focus on is what will it take in different geographies to unlock more penetration. As Krissy shared for DBS, outside the U.S. it's very underpenetrated yet considered standard of care. And for SCS, there's a few more barriers just depending on how different the geographies and cultures from a reimbursement and a perception of the therapy perspective. But maybe, Krissy, why don't you start since it is standard of care worldwide. It's just a question of penetration, and then maybe Charlie follow up with that sense.

Right. Great. Thanks. And Steve, actually, for us in DBS globally, we're about 50% of our revenue comes from OUS as well, which is a little bit dissimilar than Charlie or Anu's business. And we absolutely see opportunity for us internationally in terms of our future growth. And what we're trying to do is identify those geographies where we have the right opportunities for partnership with our clinicians, the right concentration of patient population and the referral pathway is available for us to overinvest to gain increased penetration in those markets first versus smattering our investment all over the place and perhaps realizing lower returns for those investments. And some of the key geographies that we're focused on would be China. As you noted, we're under 1% penetrated in China. We have large opportunity in Japan as well as Latin America, and our CEMA region actually is a strong growth driver for us in the future as well.

Yes, and a relatively consistent answer with what Krissy stated other than the fact that we are a much larger and more dominant proportion business in our developed markets, the U.S. and Western Europe, for example, in spinal cord stimulation, but significant opportunity, Steve, outside the United States for our therapy as well. But it's going to require, first and foremost, I think, an investment and a focus on therapy awareness. I mean in a number of these markets, there's just not -- there's not a developed understanding of spinal cord stimulation as applications and similarly with targeted drug delivery as well. So that's our primary focus in a number of these markets, but then building evidence if that evidence needs to be local, right? Investments in local versus global evidence, I think, are important considerations. One of the studies that we're pursuing, for example, around nonsurgical refractory back pain could have some application in some of our markets outside of the United States and Western Europe as we leverage there as well. And then ultimately, bringing the right type of payer coverage strategies or health care system strategies to get these therapies covered. And then finally, putting the technology into these markets as well. The pipeline that we talked about, the strength of that pipeline, making sure we can pull that through to these geographies. So it's an incredible body of work there, but a significant opportunity as both Dave and Krissy highlighted.

Okay. Thanks, Steve. Let's next go back to the line of Chris Pasquale at Guggenheim. Chris?

I had a question about how you guys think about clinical evidence in the pain space. In our conversations with clinicians, one of the topics that's come up is some skepticism about the quality of clinical data in the SCS field, how it translates into the real-world setting. So as you think about differentiating your own innovative products, embarking on all these indication expansion trials, is that something that you think about do we need more objective measures to quantify what is an inherently subjective variable in pain?

I'll take a stab at it. Dave, if you want to chime in, feel free to as well. But we have a lot of discussions around this, Chris, but particularly around how we advance this space. I can tell you from my experience in the past I gave you in introduction, I spent a number of years in cardiac rhythm, right? And you look at things like patient with a sinus node dysfunction or an AV block. If you pass out, you get a pacemaker. And they're very, very concrete measures of a patient that might need a defibrillator, for example, of an ejection fraction less than 35. Pain is highly subjective, as you called out. So if you think about -- you think about the investments that we're making, right, in our portfolio, ECAPS is a great example, right, of that investment. Another is the fact that we've got an accelerometer in both of our platforms, both Intellis and Vanta, that allows us to see patient's activity and posture, right? To begin to start to look at ways that we can correlate that patient's response or that patient's outcome as something more than a subjective measure, make it more objective. There is a promise of doing that with a technology like ECAP. So we're actually getting a quantitative view in our sense of that neural system and then be able to correlate that with other measures, physiological measures, for example, to begin to objectify this. So I think it's a very relevant discussion, an important one. We're working on that -- toward that direction. In the near term, obviously, very committed on the -- I'll say, the execution, the quality of our current clinical programs as well to deliver really, really strong outcomes for our patients. Dave, if you want to add anything, feel free there as well.

I think you covered it well. I think you can see our commitment to evidence is as strong as our commitment to innovation. We're absolutely working on objective measures as well. And I think that's something you'll see in real world evidence we'll be building on top of the prospective trials, too.

Thanks, Chris. Next, let's go to the line of David Rescott at Truist. David?

Ryan, can you guys hear me all right?

We can.

Great. Within the Interventional Pain business, I know you talked a lot about kind of going after several chronic disease states such as lumbar spinal stenosis, degenerative disk disease as they join. And just kind of wondering what the strategy here behind taking share in these segments are? I mean is this something where the existing portfolio that Medtronic has is positioned to take share here? Or would we need to see some more internal development or kind of M&A to really build out the portfolio position here?

Thanks for the question, David. This is really where we expect to see a lot of innovation. We have invested in innovation in this space. The whole focus here is minimally invasive surgery where pain physicians can do these procedures in lower-acuity setting, and surgeons can also do these procedures in lower-acuity settings. So this is where we have doubled down on innovation, and we will certainly be looking at tuck-in acquisitions as well.

And maybe I'll just add, David, that maybe for the basis of the question when you first started the question was why? And these are just large patient populations that are poorly treated and we see high growth in. So we see it fitting our portfolio well and bidding the patients that we think we can treat well.

Thanks, David. Let's see. I'm taking a look at the queue. Are there any questions? Any more questions? One last call for questions. [Operator Instructions] There, we can see a couple popping up. Let's go to the line of Jayson Bedford at Raymond James. Jayson?

Ryan, can you hear me okay?

We can.

Just a couple of clarification questions here at the end. You mentioned SCS and DBS are the 2 biggest revenue sources in Neuromod. Maybe just as a percent of total, how big are these subsegments as a percent of Neuromod revenue? And then my second question was just on nonsurgical refractory back pain. I think you said pivotal data in calendar '22. Just curious, was that U.S. or European data, because I think you mentioned you have 2 studies going?

So I'll start with the first one with some simple math, so we can get precise following. But it's something in the order of 35% to 40% of our revenue is SCS, probably roughly 25-ish percent is DBS; Interventional will be third; and Targeted Drug Delivery will be fourth.

I'll just make a quick comment, Jayson, on the timing. The initial data we'll be sharing will be our earliest data from Europe, but we will be following with the U.S. thereafter. And we'll be able to provide a little more timing on that as we kind of work through completion of enrollment over the course of the next couple of months, we expect.

And Charlie, will we see both U.S. and European data?

[Audio Gap] And we'll be close on U.S., but I'll provide a little bit more guidance on that maybe looking forward.

Thanks, Jayson. Let's go to the line of Matt Miksic at Credit Suisse. Matt, go ahead.

Yes. So a kind of clarifying question. Just on ADAPT-PD, maybe if you could flush out what the time line looks like for that. You mentioned opening it to additional centers and enrolling. Remind us sort of what the follow-up looks like, and when you think that will be in a position to be enabled on Percept?

Yes. Thanks, Matt. So as I mentioned, globally, all of our open centers are actively screening for enrollment. And we expect the completion of enrollment by Q4 of FY '22. But for competitive reasons, we're not sharing any additional time lines in terms of when we would have our results at this point.

Okay. Thanks, Matt. I think we will wrap it there. I want to thank Dave, Krissy, Anu and Charlie for their participation in today's call. And thanks to the audience for joining us today. If you have any follow-up questions, please reach out to me or Francesca or Wynne on my team. And as a reminder, a replay of this call will be available on our website, investorrelations.medtronic.com, later today. We hope you'll join us for our next episode, which we're working on and hope to announce in the coming months. Thanks, everyone, for your continued support and interest in Medtronic and have a great week. Bye.