Sync right in.
Exactly. All righty. Let's get going with our next session. I'd like to welcome Kestra Management to my right, immediate right, Brian Webster, Kestra President, CEO, and to Brian's right, Vaseem Mahboob, Chief Financial Officer. I've had the privilege of knowing Brian. I brag about this, Brian, whenever I can. I have very few.
You're going to make me feel old.
Very few claims to fame, but I think we met in the mid-1990s when Lilly spun out Physio-Control and Bear Stearns took Physio-Control public. It was a privilege to watch you turn that business around then and to follow your career over the years. Vaseem and I met about 15 years ago now, and I've had the pleasure of knowing you and working with you and watching your lovely kids grow up and everything else. Now that I've softened you up, so.
Now you're a big end.
Talk to me about 26 numbers. No. Oh, I'm not talking. Look, I'm excited to welcome Kestra Medical here because I think Kestra went, as many of you know, Kestra went public in early March. Since then, I've had the pleasure of watching the company, watching their commercial momentum build as reflected positively in the company's beat and raise performance in their July quarter, which is their first fiscal quarter. I don't want to taint the story, but they have the same fiscal year as Medtronic. That's how I remember. It's an April fiscal year. Just this week at American Heart, the company released their really compelling, outstanding post-approval study, primary results. As a reminder, Kestra's ASSURE Wearable Cardioverter Defibrillator, WCD, got FDA approved in 2021, and we've seen broad-based adoption and uptake since. Let's get right into it, Brian.
Big news since we last spoke. The ASSURE post-approval study, primary results were just presented. I feel very privileged that this is so hard on the heels of that data. Talk about the data. What's it mean for WCD adoption and obviously, most particularly, ASSURE market share?
Yeah. Yeah. Thank you for having us, first of all. Thanks everybody for being here. It was a big day for the company yesterday. Post-approval studies, as you know, are part of the regulatory process. When you get a pre-market approval from the FDA, they set certain product standards that you have to meet in a post-approval study. That is done to ensure that products, when they come to market, are safe and effective. We had, from the first patient, started enrolling in that study. We reported yesterday on an over 21,000 patient study and met our primary endpoints and met a bunch of other important secondary endpoints. I think that what it means for us, I would put it in three different buckets. One bucket is anytime you can meet the regulator's requirements, that's a good thing to do.
We met those. That means we're in a really good place when it comes to our PMA, our relationship with the FDA, and everything else. That's number one. Number two, the data that we presented was fantastic and will help us competitively because we have a device that most people would recognize as being differentiated from our competitor. This just cements that. It makes it easier at the point of sale for our reps to compete because now they have this very large study to defend our position with. That's going to help us when it comes to winning market share and competing on a day-to-day basis. We were in New Orleans yesterday, had a chance to interface with a bunch of our territory reps, and they're just very excited about the data.
The third thing I think is really important about this particular situation is this data set coupled with some data that our competitor published a few months ago, I think is going to help elevate the category. Ultimately, in today's world, wearable defibrillators are only prescribed to about one out of seven patients who are eligible for one. What we need is stronger guidelines from the AHA and HRS and also heart failure guidelines. We think that all this evidence, the combined studies between our competitor and the one we just did, that's about 40,000 patients' worth of data that very clearly identifies the risk profile for these patients and the risk level being significant enough where they need protection.
We think this is going to be, as it makes its way through the committees that identify the guidelines, we think this will be a pretty seminal moment for the industry because it's going to help us get to that next level of clinical practice. That will ultimately just open up the TAM here. There's about 850,000 patients in this TAM. Right now, we're only serving a little over maybe 120,000 of them.
Yeah. That's a great point. You highlighted in the press release yesterday the potential for the data to inform future changes to clinical practice. I think that was your language, very political-sounding. I think everybody in this room knows that changing guidelines is complex and political, can take time. Was that press release language justifiably lobbying? I mean, maybe talk just a little bit about what has to go into the next steps to make that important event happen.
Yeah. The language was very specific, to your point, and it was intended to do a little bit of lobbying without it feeling like pressure, right?
Right.
You picked right up on that. Maybe we did not do a very good job of being subtle. When the guidelines that are established by the arrhythmia committee under AHA and HRS, when those guidelines were put in place for the WCD, it was 2017 when those were done. Back in 2017, there was something like maybe 15 clinical studies, papers that had been done by our competitor that informed the guidelines. Okay? Since then, there has been a tremendous amount of evidence, including these two large ones that I just talked about. The number of studies now is something like 130 studies that will inform the committee. The evidence is there. Now we need to activate the committee to take it on and evaluate that. We are not calling our shot right now. We do think it needs to be evaluated.
I think they think it needs to be evaluated. What the timing for that is going to be is anybody's question.
Yeah. I mean, is it sort of a benign neglect kind of issue? I don't know what the right word should be here. Is it just they haven't thought about it? And the data really, I mean, did you interact with committee members? Not that it would happen so quickly, but just that they said, "Wow, it's even better than I thought." I mean, how do you gauge?
Yeah. I mean, the timing of the last guidelines, which was that 2017, it was right about when Zoll had published their best trial, which was their randomized trial. And that was a mixed results trial. The as-treated version didn't meet its endpoint. The per protocol version handily met its endpoint. That, I think, probably in the intervening years, the committee has just said, "Well, there hasn't been a big enough body of evidence to really drive us back to the table to talk about it." Nobody's saying anything publicly about it, but I know that there are a number of physicians that are involved in those circles that are very interested in taking it up.
Great. I mean, obviously, I mean, as the data showed, it's life-changing. And that was very compelling. Let's unpack the competitive aspects of this a little more. I don't know, sort of a dumb question, but how does Zoll react to the data? Do they take a, "Yes, we're one for all, and this is a class effect approach"? Or I feel like I've heard you say repeatedly, Brian, that Zoll sales reps have focused on their large clinical data sets and how they compare favorably to your historically smaller set. But now this study is the largest data set that exists.
Yeah.
What happens? How does this change the playing field?
I'd like to say that they're taking an all-for-one, one-for-all approach, but I don't think that's very likely because what they're going to recognize is that this data set is so specific, and it takes away any argument they have out in the field about their device having better clinical evidence than ours. I don't think they're going to be very happy about it. It will ultimately help the category grow and the market grow. They'll look at it in that way at some point. When you're talking about the reps out in the field, they're not going to appreciate it because it's going to be difficult for them to counter-detail the level of evidence that we have.
You said that the Kestra sales team was excited because they understand what they're going to be able to do with it. But again, I only care about me, not them. It's like, does this help them open new accounts faster? Do they penetrate existing accounts faster? Do I raise my estimates 50% or 25%? Or how do I think about what they can do now with this in hand?
I think you kind of go down the hierarchy of needs for the way a sales rep will think about their territory. The very first thing they're going to do is they're going to go to all their best prescribers, and they're going to lock them down with this data. Right? They're going to say, "This is why you've been prescribing. You were right to do that," dot, dot, dot. That's the very first step you do. The very next step is you're going to go start activating new prescribers in that same practice, in that same hospital, if you will. It's going to be with that data. That's going to allow you within that institution to grow that.
The third step, I think, is now you're going to neighboring institutions, additional hospitals that maybe haven't been as active in prescribing WCDs, and you're going to start talking to them. It's a little too early to tell to know what the impact will be. I might not jump into the model changing yet, but we certainly think it's a positive to—it's going to accrue to our favor here.
Yeah. No, for sure. One thing that intrigued me, and I don't know whether it's important or not, but just dreaming about what's next as well. I was intrigued to see that ASSURE has the ability to detect other types of arrhythmias besides VT and VF, i.e., AFib and bradycardia. I'm not sure if this is a good question or not, but does this point in some way—I'm dreaming about something that doesn't exist—that future adjacent markets or leveraging technology or relationships?
In the med tech world, especially with Class III devices, part of your responsibility as a company is to, when you go out and you do these big post-approval studies, especially ones as large as this, your responsibility is to look at that data and take that data and use it to solve even more patient problems, right, and physician issues, and learn from that data. The fact that we have comorbidities in our patient population of 72% of our patients were hypertensive, right? The fact that 37% of our patients had AF, the fact that there is prevalence of asystole and bradycardia in our patients, that is our responsibility to go and be able to provide better solutions in those areas. That is a good way of thinking about where are we going to go in the future as we expand our capabilities.
You talked about, if we step back and just look at the big picture again for a second, you talked about the one in seven patients. You talk about the low penetration. How are you thinking? And just remind us briefly, what's baked into your numbers in terms of market growth and penetration as we look at it over the next couple of years? As of Sunday.
Yeah. Yeah. The market growth assumptions that we've used have been based on— because we use the data we use is based on claims data, so it's always in the rear. The market growth data we've used is over the last three years, the unit growth has been about 6% per year. Then you have price growth because every year this category gets basically a COLA increase. You combine those two together, which is usually 2%-3%. That's 8% per year of growth is what we kind of model in. We just got the 2026 number, which is going to go up 2.8%. That's been the past. Now it'll be very interesting to see, does that market growth go faster? I think it feels to us like it is, but we haven't seen the claims data yet to prove that out.
Yeah. I feel like we've done a lot of due diligence and individual hospital physician calls. I think I'm being very honest in sort of saying, as I reflect on it, that every conversation that we've had has, in some way, shape, or form, talked about welcoming another competitor, welcoming, in particular, for women-specific designs. Is that, having the two competitors and the competitive jousting, is that changing their dynamics versus 6 or 12 months ago? Is it creating greater awareness in a constructive way?
I think what we're seeing happen right now is we came in, we disrupted a monopoly, as you know. They've been going through the different stages of grief, of denial, first it's denial. Now they're at a point where they're saying, "Well, okay, these guys, they're taking our market share. How are we going to grow our business?" They came to the simple conclusion that they have to grow the market. That's where they're focused. They're focused on, obviously, they're competing day to day, but they're also really focused on growing the market by issuing studies like they did with the SCD -PROTECT study and just the way they're advertising and everything else. They're focused on growing the market. That's okay, right? We want market growth. We think there's lots more penetration for the category.
And just remind everybody about your commercial strategy here. I mean, you have differentiated technology, compelling data now, even more compelling data, established reimbursement. So it's all about commercialization. Just give us your latest thinking about the nuts and bolts of your commercial strategy, territory expansion in network patient coverage. A lot of topics here, but maybe just at a high level.
Yeah. The high level is we're building a direct-to-cardiology sales force. We had the benefit of knowing where our competitors' prescribers were before, so we could target the high prescribers in the U.S. When we originally started to commercialize, we started targeting those folks. Now, as we've gotten more of the insurance contracts under our belt, where we try and put the sales reps is at the intersection between high prescribing volume and high payer coverage, so places where we actually have payers under contract. That's what we're spending our time on. We put qualified cardiac, typically reps that have good cardiac experience, and then we also buttress them with clinical resources.
When you get an account up and running and you're really driving volume through that account, that rep needs somebody to help quarterback that account. We're starting to kind of selectively add those kind of resources as well. One unique attribute of our commercial model that you may remember is we have a commercial execution model where we actually use contract partners to do the patient fittings. Every time we put a new rep out there, we'll put four or five of these patient specialists who will go in and actually execute the fitting for us. That gives us the ability to scale the business and handle the rapid growth that happens in any given territory.
You've been creating these new territories. How long does it typically take to ramp productivity in a new territory? I mean, are those unfolding as expected based on your experience so far?
Yeah. We think about it as I think the model we build around is about a six-month ramp from the time we bring them on board until they're up to full productivity. Depending on who you get, if you get a rep who's got a lot of physician relationships in a given territory, they may hit the ground running more rapidly. We do track different cohorts of the reps. We had sort of our original cohort of reps. We track how they're doing in terms of productivity improvements. We track the new cohorts of reps to see, are they coming up that curve at the same slope that we hope for? We're seeing both of those occur. The existing previous reps who've been around for two or three years, they're continuing to incrementally add productivity.
The new reps are getting right on the curve that we would expect. So far, that's been a really good productivity indicator for us.
Yeah. Yeah. I want to focus for a moment on a question I always get asked a lot about revenue conversion. If I'm saying it right from memory, Kestra converted 44% of ASSURE prescriptions into—so doctor writes a prescription. You converted 44% in fiscal 2025 into revenue. Talk about some of the factors that drive this adjusted conversion rate. How should we, just in the most straightforward, simple terms, do you expect that conversion rate to evolve in coming years and why?
Sure. Let me take that one. You're right. I mean, we did have a mid-40 kind of conversion rate. I think it's our way of kind of giving the street and the investors a sense on how effective and efficient are we in converting those prescriptions to revenue because we're not providing any productivity numbers because we felt that we were the only public company out there. We don't want to put our strategy in the public domain. There are three key components to the conversion rate. The first one is really the ability to take that prescription and convert it into a fitting. Not all prescriptions become a fitting for good reason. Sometimes you get a prescription, but unfortunately, the patient passes away. There's a 20% coinsurance for this KO606 cord. Some people think it's too expensive. Don't want to wear it.
Whether it's a Zoll device or ours, they just won't wear it. There are some good reasons why a prescription does not become a fitting. We think we have already seen a big advantage of about five to six points in our fill rate, if you will, versus Zoll. We think Zoll is in the high 70% range. We are in the 85% range. We have been consistently in that 85% range for a while. The second bucket is really around the ability to convert that fitting into a claim. Because as you know, it's a rental model. Every 30 days, you have to submit a new claim to the payers to get paid. We have said that being in network totally unlocks the rental model, right?
As we have seen better coverage on the insurance side, and we reported at the end of last year that we had 70% of our patients who were in network. Last quarter, we said we had done 80% or so. That really helps streamline the process of submitting that claim. And quite frankly, a lot of these patients do not have any out-of-network benefits. In those cases, you actually have to basically take a write-off for those. We think, and Zoll has actually published the data, they are at about 98% in network. We have closed the gap significantly in the last 18 months. If you remember, we were in the 60%-70% range, now 80%. That will happen over time. There is a pretty long tail of insurance payers in this cover.
From a covered lives perspective, we are in the 90% plus range, but the mix, that 10% delta will change. We have been very intentional and deliberate in our commercial strategy that as we are putting reps or deploying reps into new regions, we are actually making sure that not only do we drop them into insurance prescription density regions, but also areas that have high insurance coverage. That has really helped us accelerate that from 70%-80%. It is not going to go from 80%-90% overnight, but it is going to be happening over time. Finally, the last part of the conversion rate is really the difference in us having been in the market for a couple of years and Zoll has been out there for a long time.
We suspect and we know that they actually are on accrual accounting, but for us, we're mostly cash-based accounting. We have to wait for that cash to come in. It's just a timing delta. As we create that history, take that back to our auditors and show them that we can actually collect that cash when we submit the claim, we think we'll shrink the time on that cash piece of it. The good news here is when we think about the mid-40s, we don't have to get to 100%. When we do the math and you look at those conversion rates that I talked about, Zoll versus us, we think they're in the high 60s.
We just have to go from the mid-40s to the high 60s and the current sell-side models based on what's out there have us getting to in the high 50s over the model period, which is in fiscal year 2028. Again, a lot of different components, but we have made very good progress and have given an aside to those KPIs and they're all tracking in the right direction.
That's very helpful. Brian, I don't know why I can't help myself. I have to ask about what's next. Got to look ahead, right? You've been your usual opaque, I'm trying to say, maybe I can say it nicer. You're your serious conservative self and haven't shared much, but is there a pipeline? Are there other products? Or no, the opportunity here for the next three to five years is so significant given the under penetration, et cetera, et cetera, that that's all you need to be focused on.
Yeah. Obviously, we're not going to put our R&D pipeline out in the public arena. So you know why I'm being opaque. But I think for us, innovation is really a core principle at our company. We have more patent assets in our company than we have people. And so it would be unnatural for us to not innovate. So we are still investing in our R&D engine. We have some exciting stuff in the works. And we have our platforms, three different platforms that are distinct. One platform is the wearable platform that we've got some exciting innovation that we're working on. We have the WCD platform that we have some exciting innovation. And then we have the digital platform, which is something that we innovate more rapidly in because it's not a class III device. And so yes, we have a pipeline. Yes, we are innovating.
We do believe we've got some things that will be really exciting and help us to extend the product differentiation that we have. That's really ultimately our goal. We don't want our competitor to think that there's an opportunity for leapfrog here. We're going to keep extending the bar there.
We had a conversation somewhere early on in this process, the IPO process. You impressed me very much with talking about the company's evolution and the history sort of inside Stryker, sort of before it got to Stryker. Inside, and you made the point to me, I forget your exact language, but that the whole bones of the company are more evolved and matured and sophisticated than people understand because of that sort of incubation period, if you will, inside Stryker. I just thought it'd be interesting for people to hear that.
Yeah, the nature, ultimately, we were a spinout of a spinout, right? Physio was a spinout from Medtronic, and then we were a spinout from Physio. As part of that spinout from Physio, we were able to have our engineering, operations, clinical teams all be embedded within that Physio-Control Stryker environment, which is a very mature Class III medical device, very mature quality system, very mature supply chain, all those things. We had the benefit of that through our strategy on how we did that. We did not have to go back and re-engineer stuff because we did not do it under a mature quality system, which a lot of startup companies have to do. We had mature design controls. We had all that stuff. We got the benefit of that.
Even our supply chain that we use today, which is a world-class supply chain, a lot of startup companies, because of their low volume when they start up, they cannot attract a supply chain like that. We were able to because we were using the leverage of that relationship within that environment. A lot of those things, I think, led to a really, really good product. We are seeing that in our clinical results and also the reliability of the product. The supply chain is the same, a really well-functioning supply chain for the same reason.
Yeah. Yeah. That makes sense. Maybe talk a little bit about guidance. You obviously reported a terrific quarter in September. I know you're in the middle of, it's probably really your quiet period, even as you get ready for the next quarter. Talk to us about your approach to raising guidance, your confidence, and your now more positive incrementally outlook and how we think about your philosophy going ahead. I don't know if it's for the team or for you, Brian.
I think one of the things we talk about a lot, Rick, is we had a run rate business. In the last two and a half, three years that we've been on the market, we have collected a lot of data and a lot of information that gives us a lot of predictability, if you will, on where the business is going. On top of that, we are able to take those run rates and do all of the regular math on the productivity numbers, the rep count that we have, the visibility that we have on the market. With the solid, consistent execution, we are able to get internally, and we've shown this before we went public, that we could predict the number with a very fine precision. I think that's important. That's the foundation.
The second part of it is we are also a new public company, and we feel that our credibility is one of our biggest assets. Coupled with strong, solid execution and an aspirational goal, we still want to be able to put numbers that we can always beat and raise. That's really the philosophy. Nothing very complicated. It's just pure solid execution.
I think you promised me early on every quarter you beat and raise, but I won't say that publicly. I don't want anybody to hear that. Annie, I think you had a question.
Hi. Yeah. I just wanted to circle back to Brian's comments around Salesforce expansion. I think in the past, you had mentioned plans to double your birthday sales rep count over the next couple of years. I'm just curious if that's still a good baseline to think about the future Salesforce expansion and if we could sort of imagine that building even faster.
The comment about doubling the Salesforce was that was at the time of the IPO at a time when we had about 70 reps. We said over the next couple of years, we're going to probably double that. That was that math. We're certainly on or even ahead of that trajectory right now. I think the last big question that we had to answer before we really decided whether it was appropriate to go faster or not was this question that we answered yesterday. I think now we're going to roll all this stuff out. We're going to assess how our team does with it. That'll allow us to make decisions about when and if to try and go even faster with the sales team.
Having the clinical questions buttoned up, because I viewed that as the last thing, if those clinical results came out and they were not stellar, that would be the last thing that would have slowed us down in terms of competitively. We have climbed over that bridge now. We feel like we are in a good position now.
We're actually going to tell him the clock started late. We're a couple of minutes over.
Wait a minute. I got three and a half minutes left.
I know, but you just wrapped it up so beautifully with that comment that I think that's a high point. Before I descend further into my low-life comments, I think we should end. Thank you both. Really appreciate it. Congratulations on the data. Clearly a major milestone, positive milestone.
Thank you.
Thanks so much.
Appreciate it.
Thank you.
Thanks for letting us.