iRhythm Technologies, Inc.
Q2 2020 Earnings Call Transcript

Published: 9 Aug 2020

[Operator:]

Thank you for standing by, and welcome to the iRhythm Technologies Q2 2020 Earnings Conference Call. . I would now like to hand the conference over to your speaker for today, Leigh Salvo, Investor Relations. Please go ahead.

[Leigh Salvo:]

Thank you all for participating in today's call. Joining me are

[Kevin King:]

Thanks, Leigh. Good afternoon, and thank you for joining us. On behalf of the iRhythm team, we hope you're remaining safe and healthy. I'd like to start our call by recognizing the iRhythm team. Over the past few months, I've observed our team rallying to meet the challenges, demonstrating incredible resilience and operating at the highest level, all while adopting to a new work environment. Despite the challenges, we have continued to deliver our service without interruption to the physicians and patients that rely on it. We recognize the need for high-quality care has never been greater, and the iRhythm team is intently focused on delivering the care needed in today's environment. I'd also like to welcome Doug Devine to our team. Doug joined us during an exceptionally challenging and unusual time of our business. Despite that, he was able to immediately step in to provide a very smooth transition, and has already demonstrated the impact of his leadership on our finance organization and input on our long-term growth objectives.

[Douglas Devine:]

Thank you, Kevin. Before I jump into my comments on the quarter, I'd first like to express how excited I am to join iRhythm and to thank Kevin and the Board for offering me the opportunity to contribute to the future growth of a great company and a great team. The second quarter of 22020 undoubtedly goes down in the record books as one of the most challenging business environments all of us have ever experienced. iRhythm rose to the challenge rapidly and successfully shifting our business model to accommodate our physician customers and their patients. We expanded home enrollments from a single-digit percent to over 50% of volume at peak, maintained traction onboarding new accounts with evolving sales models and executed internally on many aspects of our operation in a remote environment while at the same time reducing expenses, preserving liquidity and cash.

[Operator:]

. And our first question comes from Robbie Marcus with JPMorgan.

[Lilia-Celine Breton Lozada:]

This is actually Lili on for Robbie. Could you provide a bit of color on the use of ZIO in acute settings in the quarter? I understand you probably don't want to break out specific numbers. But how big of a benefit was the acceleration in adoption here? And are these tailwinds something that we can expect to continue to see in the back half of the year? Or will this kind of slow down as the virus abates?

[Kevin King:]

Lili, this is Kevin. What - the acute setting, are you referring to ZIO ATs used in hospital?

[Lilia-Celine Breton Lozada:]

Yes, that's right. Sorry about that.

[Kevin King:]

Yes, for inpatients. That level has decreased. And the uptick in ZIO AT volume we're talking about is in the traditional ambulatory outpatient cases, where the likelihood or possible threat of a life-critical arrhythmia exists. Many of the patients that were in the COVID environment back in the March, April time frame, when we gave the May reporting, those numbers, too, were a little bit on the smaller side. A vast majority here is ambulatory-related traditional market. And we're extremely confident in that adoption rate that we're seeing right now. This is the core market that we're growing ourselves into.

[Lilia-Celine Breton Lozada:]

Great. And just one quick follow-up. As you guys mentioned, there's clear benefit to ZIO over traditional Holters in this environment, given the single-wear nature of the device. So what have you been hearing on doctors on how this has impacted their adoption? And do you think that this could have lasting impacts longer term post virus?

[Kevin King:]

Yes. In a similar way to how we're seeing telemedicine become adopted due to the pandemic, we're also finding on the Holter side, this is much of an accelerant - COVID is an accelerant to adoption. In many cases, patients are refusing to wear medical devices that have been - that are reused or have been worn by others. There are staff constraints. And then of course, just the ability to do Holter monitoring via home enrollment with a device that has limited capacity or a hospital would have limited number of Holter monitors, when we have a single-use wearable with essentially limitless inventory to provide to accounts for home enrollment, there's major advantages here. And then of course, all of the demonstrated clinical superiority of ZIO is weighing in here as well in a big way.

[Operator:]

And our next question comes from David Lewis with Morgan Stanley.

[Calvin Chu:]

This is Calvin on for David. Just kind of a related question, could you comment on how resurgence has impacted either June or July results in sort of either direction in terms of both the underlying demand from regular way ZIO patients as well as, to your point perhaps in the context of constrained hospital capacity and resurging hotspots, resulting in kind of an increased demand for ZIO to capacity?

[Kevin King:]

Sure. Calvin, it's Kevin. Look, I think this sustained and rather spiky nature of COVID-19 has created a really, really heterogeneous market with demand levels being varied in geographic locations and in accounts. So within areas that are hotspots, we clearly see a high degree of variability in our daily and week-over-week registrations. I would say, even in recovered regions, there's nonuniformity. It's almost like a lingering effect from COVID-19. And as we stated in the prepared remarks, many accounts have not returned to full growth yet. So I think the effect of COVID-19 is really depressing demand within the marketplace overall. That said, where there are opportunities, we do think that we are taking up a larger percentage of the markets through the benefits of our single platform, the wearable biosensor that's clinically superior to other approaches. I just mentioned this to Lili. Our ZioSuite information system is having impact on workflows as it helps accounts, especially those accounts that have reduced staffing levels due to layoffs, and our ability to deploy home enrollment via the ZioSuite application. And so in the cases where there is demand and patients are getting to the hospital, I think we're getting a disproportionate percentage of those. That said, part of the market seems to be cut off, if you will, due to the increase in spottiness and spikiness of the nature of the virus here. I probably just may just add one comment there. I do think that accounts are better prepared now than they were in March. Many of them have put in place staff and patient safety protocols. They have limited access to accounts for us. But they have been able to deal with this qualitatively. They have been able to deal with this in a better way than they were back in the March-April time frame. And many, many accounts just completely shut down. I think that we hear less of that, it's probably more about capacity constraints right now.

[Operator:]

And our next question comes from Margaret Kaczor with William Blair.

[Brandon Vazquez:]

First, I just wanted to see if we could talk a little bit more about the comments on kind of gradual increases or gradual improvements as you went into July. I was wondering if you could quantify that at all a little bit, I was trying to trying to understand, I can appreciate you're going to return back to year-over-year growth. But what does that look like kind of on a sequential basis? How much above 90% of pre-COVID levels might we be at?

[Kevin King:]

Doug, do you want to comment on that?

[Douglas Devine:]

Sure. I mean July was a slight uptick from June. And then I think as we have highlighted, given the COVID situation and given that we're seeing great variabilities between our accounts. It's a - it's difficult to predict where September is going to go in this model and where August may go. So I mean I think we've led you directionally that trending slightly up from 90% and that we're viewing Q1 levels as being a reasonable level of expectation. But we're not in a position to be more specific than that at this point in time.

[Brandon Vazquez:]

Okay. That's helpful. And then also, I was curious, the adoption of ZioSuite, and that sounds great and it sounds like it's getting a lot of traction. I was curious if there's any difference in utilization or growth rates in accounts that have adopted ZIO, any noticeable trends, either positive or negative, I would guess positive, that you've seen in those accounts.

[Kevin King:]

So we've spoken in the past about our innovation stack. The 4 or 5 layers of information system stack was most recently rearchitected and launched as - under the brand ZioSuite. We now have all of our accounts or nearly all of our accounts migrated to ZioSuite. And we - this is the benefit of having a digital information system platform that's cloud-based and so forth. So all of our customers or nearly all of our customers, the best of my knowledge, have migrated the ZioSuite, and we're getting really, really strong feedback on the benefits of ZioSuite relative to staff productivity. And as I mentioned earlier, a lot of our accounts have had staff layoffs. And so they're being asked to do more with less and the ZioSuite is helping them when it comes to ordering monitoring devices, tracking where patients are, getting reporting and things of that nature. Plus it's a great productivity boost for physicians if they're working from home because of the ability to use your tablet, your desktop, your cell phone and so forth for ZIO. So I would say that it's been a great success and it's fully deployed and it's having an impact compared to what we had called ZIO Reports previously.

[Brandon Vazquez:]

Great. And then one last one on my end. Any updates on kind of the high-risk market? I think we were originally thinking that we'd see some mSToPS and SCREEN AF data in 2020. Is that still the case? Or any other updates there?

[Kevin King:]

Sure. Dan? Dan can take that one for you.

[Daniel Wilson:]

Brandon, it's Dan. So maybe a couple to call out for you there. So mSToPS, we still expect the 3-year outcomes data potentially at AHA in November this year, so excited about that. SCREEN AF, if you recall, that was on deck to be presented at a conference earlier this year in the May time frame, which that conference got postponed, so unclear when that data will be presented. I think the investigators are trying to find the right venue or journal to present that data. And then the third one I'd call out for you is GUARD-AF, which kicked off late last year. That trial was paused in March due to COVID but has since been restarted last month. And like our commercial business, the trial has now adopted our home enrollment service as well as some other virtual features. So that one is just getting back up and running after getting started late last year. So too early to give any potential timelines around that one. But like mSToPS, that does have stroke outcomes data. So we're excited about both of those.

[Operator:]

And our next question comes from Kaila Krum with Truist.

[Kaila Krum:]

And welcome, Doug, to the conference call and the team. So you guys mentioned in the press release that you think that lower volumes in the quarter were in part offset by a higher ASP. So can you give us the split between volume and price if it was meaningful in the quarter? And then what contributed to that price benefit? Is it just standard business mix with XT? Or is that tied to AT? I'm trying to understand if AT is big enough today to be a meaningful contributor at this point.

[Kevin King:]

Yes. I can maybe take up on the ASP mix question and maybe Doug can take the second half. Or Doug, if you'd like to take the whole thing, go ahead.

[Douglas Devine:]

Yes. I'll go ahead and take it. So first, on the ASP, it was a healthy ASP kind of mid-single-digits type of uptick in ASP. Now as you're aware, AT has a meaningfully higher ASP than XT does. And so half of that increase was driven by the change in the mix, where we saw AT units increasing quarter-on-quarter and we saw XT units decreasing on quarter-on-quarter. So that kind of magnified the impact you were seeing from AT. And then the second piece of it is that we are seeing some more general improvements in our revenue cycle management, which led to the remainder of most of the increase. Taking the second part of your question on the impact of AT. The impact of AT is growing. It is still well below 10% of our revenue. And we'd say directionally, as it continues to grow, which we expect it to and have strong confidence that it's going to, we will provide steadily greater detail on the breakouts of AT in the future.

[Kaila Krum:]

Great. Okay. That makes sense. And then it sounds like you guys are - or have been sort of looking at your long-term growth vision. I think you mentioned that Doug has already been able to provide some input there. So I imagine that's something you guys evaluate and reevaluate over time. But are there any initiatives that you now feel maybe more confident implementing that you may not have otherwise, just given the reimbursement update and expected rate increase?

[Kevin King:]

Kaila, I think we've always been confident in the reimbursement outlook, even prior to - obviously prior to this Tuesday or Monday or Tuesday's announcements or information out there. We've been - we've not altered our strategy because of the reimbursement, favorable reimbursement or potentially favorable reimbursement here. And our confidence has remained the same, driving new indications, driving geographical expansion, driving new forms of clinical evidence that can open up new markets, like the silent atrial fibrillation markets. Platform investments, we've essentially modernized or rearchitected 3/5 of our technology platform in the last 18 months. And similar to what I just described about ZIO AT, these things are being invested, rolled out and having incremental impact and keeping our platform fresh and current and highly competitive. We're just continuing to do that, we're not taking our foot off the gas here at all nor are we really changing our strategy because of the confidence. You bet, Kaila.

[Operator:]

And our next question comes from Cecilia Furlong with Canaccord Genuity.

[Cecilia Furlong:]

I guess I wanted to follow up first on mSToPS as well as SCREEN AF. But just how you think about the rollout of this and the impact in 2021, but really specifically, your thoughts around how screening in high-risk patients plays into a post-COVID or COVID-altered world and really the ability to shift practice.

[Daniel Wilson:]

Cecilia, it's Dan. I would - I guess I would just start by saying we - as we've looked at what's going on in the health care environment today, our conclusion is that there's potentially more asymptomatic or undiagnosed AF in the population than there ever has been. So I think that's the first point that we're even more confident that this is a market that we should be going after and investing against. On mSToPS, that is - it is an important trial, given the outcomes data and really the first opportunity to show that targeted detection of asymptomatic AF can potentially lead to improved outcomes, including hopefully a reduction of strokes. That's been our hypothesis all along, and we have had favorable data to this point suggesting we are on the right track. But this will really be the first opportunity to see that data come together. And we know that, that is important data from a market development standpoint, whether it be with payers, physicians or even clinical guidelines, like the USPSTF prevention screen task force. So we're really looking forward to that data later this year. SCREEN AF is important as well. And we're excited for that data to come out. And as I mentioned earlier, GUARD-AF, like mSToPS, will have stroke outcomes data as well. So we really believe things are lining up well for us in this initiative. It will take time as the clinical data comes out and we're - with that data looking to change behavior. So we're excited about it and believe we're on the right path. I think it's too early to say we'll see anything from a commercial standpoint next year. But we're absolutely moving in the right direction.

[Cecilia Furlong:]

Great. And if I could just ask just any updates on your collaboration with Verily, ability to really start hiring people into that program again and just kind of timelines and relative to your kind of pre-COVID expectations.

[Daniel Wilson:]

Kevin, I can take that one. So I think we mentioned on our first call - or I'm sorry, our first quarter earnings call back in May that we had surpassed the development milestone in May. So that was an important milestone. And as we have talked about before, we're developing an end-to-end solution, combining technologies from both parties with Verily's Study Watch. Study Watch is one potential component of that solution. The collaboration has gone quite well to this point, and we continue to tick through milestones relatively on schedule, albeit with minor delays due to product development and specifically hardware development work being more difficult to do in a remote environment. But overall, we're on schedule, give or take a quarter or two. So nothing specifically to call out in terms of next steps other than continues to move forward. There's a decent chance we'll hit another milestone later this year or early next year. And similarly to my comments on the silent AF market in general, I think it's too early to point to any kind of commercial impact from this. But again, it is moving in the right direction.

[Operator:]

And our next question comes from Suraj Kalia with Oppenheimer.

[Suraj Kalia:]

So first question, Kevin, for you or Doug. And Doug, forgive me, I did not follow your commentary exactly. So there was a net 5% increase in ASP. ZIO XT price was down quarter-over-quarter. But AT was up quarter-over-quarter. I guess within the context of the codes currently used, how sustainable are these price increases for ZIO AT? And am I right that the AT price increase was in double digits in the quarter? Maybe I didn't connect the dots.

[Douglas Devine:]

So first, yes, I mean, correcting a couple of points. So first, I said it was mid-single digit. I don't want to be as specific as putting a number to it on the pricing. Now ZIO AT prices were very consistent quarter-on-quarter. So what changed is that ZIO AT became a much greater fraction of our mix. And - I mean not much greater - ZIO AT units grew quarter-on-quarter. ZIO XT units declined quarter-on-quarter. ZIO AT has a significantly higher ASP than ZIO XT. And so that is accounting for half of the overall ASP on a per unit basis on the quarter. And then as you look at the other side - the other parts of the revenue cycle management, we do believe that those are sustainable. Some of it was negotiations. Some of it was just doing a better - continuously improving the reimbursement processes.

[Suraj Kalia:]

Got it. Now it's clearer. And Kevin, one last and I'll hop back in queue. I presume you will be supplying the invoices for various components to CMS before the final reimbursement rule comes out.

[Kevin King:]

Sure. As I said on the call, I think it was yesterday, we provided to CMS over 500,000 invoices for our service across contracted, non-contracted, Medicare, self-pay, client bill. They have full access of all various and sundry types of payments over an extended period of time. And they have everything they can get from us.

[Operator:]

And our next question comes from Marie Thibault with BTIG.

[Marie Thibault:]

Looking forward to getting to know you. I wanted to ask a question about the market share commentary you gave. It's definitely encouraging and it makes a lot of sense. Is there any way to sort of quantify what you're seeing in terms of that share shift? I understand it's very difficult in this environment. And then secondly, do you believe some of those underlying factors, which sound like they're part of a larger social trend, you believe that's sustainable to help you maintain some of that market share shift?

[Kevin King:]

Sure. So we - the data that we have is iRhythm company-specific data that we gather from our customers with very good intelligence on prescribers, prescribing patterns, prescribing mix relative to traditional Holters and event monitors and traditional MCT devices across the thousands of accounts that we have. And we can trend those over time. And through our sales operations calls that we have on a monthly basis, we get a good feeling for how things are trending. And when we see increases in volumes and accounts, we're often asking, "Are these volumes coming from new prescribers, existing prescribers and what is the mix?" So the data is gathered internally. It's consistent, it's reliable. I would also say, compared to other companies that have reported in the category, we were down 3% year-over-year. And I think other companies who have reported were closer to 20% to 25% down year-over-year. So that would imply to us in a market that decreased that we have taken a bigger piece of it.

[Marie Thibault:]

Sure. Makes a lot of sense. And then I guess my follow-up question would be on your sales rep count in the quarter and what are your hiring plans? I think you'd hoped for 160 or so by the end of the year, whether that's being maintained or if there are any changes there.

[Kevin King:]

Yes. Obviously, we didn't do much hiring here in the second quarter. We only recently restored hiring of key positions. So really nothing meaningful in the second quarter per se and a lot by what happens in Q3. I don't have a number off the top of my head. But my guess is it's probably going to end up being less than 160, just given the delay in the hiring pipeline and needing to restart that pipeline up again.

[Operator:]

And our next question comes from Gene Mannheimer with Colliers.

[Eugene Mannheimer:]

Congrats on the great progress here. I just had a couple of follow-ups on the reimbursement. Kevin, you said - you said that yesterday, CMS published some modifications to the RVUs that go into the payment calc, where you'll drive a small benefit. I'm just wondering if you can quantify that for us.

[Kevin King:]

Sure. So on August 5, CMS published a, I guess you'd call it, a correction. And I don't think anybody really codes should equal a global code value. And initially, as reported, they did not. So the sum of the hookup and interpretation, the technical code should equal the global code. In that first pass release, it didn't. And then within the day, it was corrected and they now do. And when that happens, the technical code went up and the global code went down by almost the same amount. And then the hookup and interpretation were sort of in the fractional percentage movements downward. We reported if we calculated 2019 revenues, mix and all of the other things that the impact would have been low single digits. And now we believe it would be high single-digit impact year-over-year to the positive.

[Eugene Mannheimer:]

Wow. Okay, that's great. Okay. And another question on, I guess, how things can change between now and December. Historically, does the reimbursement tend to change from the proposed rule to the final rule? And if so, has it veered very much from that proposed rule?

[Kevin King:]

I think the big factor here, I guess, is the conversion factor that all of the RVUs and the physician payment system get multiplied by to arrive at a price point. And what was proposed in the rule here was about a 10.6% decrease in conversion factor across all categories, not just the code set that we use but for everything. And my guess is that, that is going to be heavily debated. It's a fairly large decrease. And I think in prior years, it's been nowhere near that level. There is a reason for that. And it's my understanding, I'm hoping I'm correct, but physician payment for codes that are called evaluation and management, E&M codes, went up substantially and that CMS is required to operate a balanced budget format, so they can't just pile on more expense. They have to - when something goes up, something else has to go down. And it seems like the best way that they were able to facilitate that was to just drain more water out of the pool through the conversion factor. So my suspicion is in the budgeting process, that's going to be highly debated. As far as on the code structure side, I - the process was so thorough and so complete, I'm hoping that there's not much to change. But of course, there's the comment period. And we'll see what happens.

[Eugene Mannheimer:]

Okay. Great color. So last one for me then, just in terms of your home enrollment trends. So let's say that volumes did return to near-normal pre-COVID level, call it, 95% to 100%, what - where does home enrollment registration plateau in your view?

[Kevin King:]

It's a good question. We said in our prepared remarks, Gene, that we think this 30% level, slightly plus/minus a point or 2, around 30%, feels right to us. A lot of accounts are loving, if you will, the ability to order things remotely without having patients come into the office, particularly patients that have already had prior studies or exams, drug titration, follow-up to ablation, subsequent ZIO Patches, things of that nature, plus even new cases, which are being seen today. So I think that, that's here to stay. And it's probably going to get built off the backs of what we hear about telemedicine being here to stay as well, that telemedicine had been on the kind of on the sidelines for a long time and then it got pushed to the forefront. And many physicians are really liking it. Many physicians are feeling that they're doing a very good job in seeing their patients remotely and probably won't go back. So I'd call it about 1/3 of our business, 30% of our business is probably the plateau that we're hoping for. We're able to do 100% or very close, very soon be able to do 100%. So if the COVID pandemic here spikes up - God, we hope not. But if it were, we would be able to sustain our operations all the way up to 100%.

[Operator:]

And ladies and gentlemen, this concludes our Q&A portion of today's conference. I'd now like to turn the call back over to Mr. Kevin King for any closing remarks.

[Kevin King:]

Great. Thank you, operator. Thank you, everyone, for joining our call today on our Q2 2020 earnings call updates. We appreciate your continued interest and support of the company and continue to wish you great health and great safety throughout this period of time. I will look forward to talking to you later. Thank you. Bye-bye.

[Operator:]

Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect. Everyone, have a great day.