iRhythm Technologies, Inc. (NASDAQ:IRTC) Q2 2023 Earnings Call Transcript August 3, 2023

iRhythm Technologies, Inc. misses on earnings expectations. Reported EPS is $-0.61 EPS, expectations were $0.75.

Operator: Hello, and welcome to today’s iRhythm Technologies, Inc. Q2 2023 Earnings Conference Call. My name is Bailey, and I will be your moderator for today’s call. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. [Operator Instructions] I would now like to pass the conference over to our host, Stephanie Zhadkevich. Please go ahead.

Stephanie Zhadkevich: Thank you, all, for participating in today’s call. Earlier today, iRhythm released financial results for the second quarter ended June 30, 2023. Before we begin, I’d like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. These are based upon our current estimates and various assumptions and reflect management’s intentions, beliefs and expectations about future events, strategies, competition, products, operating plans and performance.

These statements include risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our most recent annual and quarterly reports on Form 10-K and Form 10-Q, respectively, filed with the Securities and Exchange Commission. Also during the call, we will discuss certain financial measures that have not been prepared in accordance with U.S. GAAP with respect to our non-GAAP and cash-based results, including adjusted EBITDA, adjusted operating expenses and adjusted net loss.

Unless otherwise noted, all references to financial metrics are presented on a non-GAAP basis. The presentation of additional information should not be considered in isolation of as a substitute for or superior to results prepared in accordance with GAAP. Please refer to the tables in our earnings release and 10-Q for a reconciliation of these measures to the most directly comparable GAAP financial measures. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 3, 2023. iRhythm disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

And with that, I’ll turn the call over to Quentin Blackford, iRhythm’s President and CEO.

Quentin Blackford: Thank you, Stephanie. Good afternoon, and thank you all for joining us. Brice Bobzien, our Chief Financial Officer; and Dan Wilson, our EVP of Corporate Development and Investor Relations, join me on today’s call. My prepared remarks today cover business updates during the second quarter of 2023 and progress we’ve made against our growth and operational initiatives. I’ll then turn the call over to Brice to provide a detailed review of our financial results and updated guidance. In the second quarter of 2023, we realized continued growth across multiple channels and built on the solid momentum we saw in the first quarter of 2023. We recognized record quarterly revenue of a $124.1 million in the second quarter, which was ahead of our expectations and represented 22% growth compared to the prior year.

These results were driven by continued strong volume from both Zio XT and Zio AT as we continued to see near record levels of new account openings, opened additional large national accounts, continued to gain traction within the primary care space, and increased our market penetration within existing accounts. Fueling this growth was a continued market shift away from the short-term Holter usage towards long-term continuous monitoring as well as Zio XT outpacing the growth of an expanding ACM market. The second quarter was also the first full quarter that CAMELOT data was available for our commercial teams to use in the field. The clinical value of Zio XT versus other modalities and brands is resonating with our customers, driving account wins and impacting account retention.

While early, payers are also responding positively to CAMELOT data, and it is influencing payer policies, including recent successes where previous utilization of Holters or prior authorization requirements for long-term ECG are now updating their policies and removing these requirements. Full manuscript publication of the CAMELOT data in a peer-reviewed journal is in process. We are also beginning to expand into additional analyses of these real-world data to further demonstrate the clinical value of the Zio services to patients, physicians, payers and healthcare systems. We are also making meaningful inroads with driving EHR Integrations, which are intended to allow for an administratively simpler process and integrate Zio into existing workflows of our customers and their staff.

Through incredible cross functional efforts by our internal teams and great collaboration with our customers, we achieved a significant milestone this past April, with 1 million all-time registrations for the Zio services received through EHR integrated accounts. We believe this is translated to an estimated 175,000 hours of time back to our customer’s staff to support patient care, in which we project may have saved health systems and estimated $4 million in staff time cost. The pace of EHR Integration at both new and existing accounts has only accelerated throughout 2023, with the total volume of registrations through EHR Integration, up more than 60% year-over-year. We are very excited to continue this progress and to continue developing innovative solutions for our customers as we strive to serve millions more patients within the coming years.

As we move into the back half of 2023, we also are eagerly awaiting the upcoming Zio Monitor Launch later this quarter to provide our next-generation device for our best-in-class long-term continuous monitoring service. We believe that compared to Zio XT, this thinner, smaller, lighter, more breathable device can improve patient compliance and diagnostic yield as a result of extended wear times. Initial real-world data from the first 673 patients who wore Zio Monitor were presented at ACC this past March, and the first market evaluation phase was concluded in May with the Zio Monitor being used by 6,000-plus patients over a 12-month period. The market evaluation data confirmed the findings from ACC and showed that when compared to Zio XT, Zio Monitor showed an increase in patient compliance and diagnostic yield as well as delivering the same high-quality service.

As we move into full commercial launch, we are planning a purposeful rollout strategy designed to support our customers and patients with the best-in-class service they have come to expect from iRhythm. To do this, we are implementing a phased rollout that allows us to bring availability of Zio Monitor to patients as quickly as possible while making sure that we transition away from Zio XT in a measured fashion. We look forward to sharing additional details with you in the months ahead. Turning to additional pillars for iRhythm’s long-term sustainable growth, we’ve recently had several milestones essential to strengthening our international presence. In Japan, we are thrilled to announce that we were granted high medical needs designation by the Japanese Ministry of Health and Welfare or the MHLW in early July.

Worth noting, this designation is specific to Zio, giving us a differentiated position in this large market. As a reminder, Japan is the second largest ACM market in the world with 1.5 million ACM tests prescribed annually. Japan still utilizes the Holter monitor as a standard of care with very limited adoption of patch-based technologies, resulting in a very attractive point of entry for Zio as a disruptive, innovative technology, and service. By working closely with the Japanese Heart Rhythm Society, our teams did an exceptional job using Zio’s extensive clinical trial evidence and differentiated AI to help the MHLW appreciate Zio’s clinical value when compared to the existing Holter standard of care. Following this designation, we submitted our Shonin application for regulatory review in July.

Importantly, the designation enables priority review for marketing authorization by the Japanese pharmaceutical and medical device agency or the PMDA, and it also paves the way for potential premium pricing specifically for Zio in Japan. We will continue to work closely with the PMDA during the review of our Shonin submission and look forward to updating you on the progress in future quarters. In Europe, we were also pleased to announce that we have opened our first market evaluation engagement in Switzerland, with early onboarding of one of the country’s five university hospitals. This initial engagement will allow targeted healthcare providers to experience the Zio service in preparation for a broader commercial launch in the future. As shared in our strategic plan at our Investor Day last September, this market priming phase represents the initial steps of our international growth plan to accelerate access to long-term cardiac monitoring to more patients worldwide as we gain experience with regional reimbursement dynamics in parallel.

While we are hyper focused on execution within our growth pillars, I’ve also been pleased with the progress made to drive operational excellence throughout the organization, enhancing our financial profile and preparing to scale the business for future growth. We achieved a significant milestone in our global business services center in Manila during the quarter as we welcome the first wave of full-time employees. We’ve been very pleased with the progress made in our ongoing business transformation activities as is being demonstrated by the nice improvements in our financial profile this quarter. Lastly, as previously disclosed, we received a warning letter from the FDA on May 25th, which focused on our Zio AT system and the alleged non-conformities related to medical device reporting requirements and quality system requirements.

Since receipt of the warning letter in late May, we have engaged with the FDA and submitted a thorough response. We have been encouraged by the collaborative engagement with them and believe we have now clarified with the agency, the labeling modifications that are needed to improve the user’s understanding of the Zio AT system and how the device is used for the provision of ambulatory mobile cardiac telemetry services. In addition, we have proposed enhanced design features to the product that further address areas of focus while also following the FDA’S direction to work with the CDRH product review team regarding changes that occurred under letters of the file and the potential need to submit a 510(k) as a catch up for changes to the Zio AT system.

While we understand the FDA continues to review our responses, we are pleased with the progress and we’ll continue to work collaboratively with them to address their concerns. While always subject to change until the review is completed, we’ve agreed to make their requested labeling changes that will allow us to continue to market Zio AT as a device for ambulatory MCT services. We remain committed to our customers, patient safety, quality, and compliance, and we will continue to work diligently and collaboratively to resolve the warning letter to the FDA’s satisfaction. Considering the proposed design enhancements and other commitments related to the Zio AT system, we do expect our original timeline for the submission of our next-generation Zio MCT system to be impacted.

Based on current estimates, we anticipate Zio MCT to be delayed by approximately 12 months as we work through the product modifications for Zio AT and potential regulatory filing requirements, resulting in a 2025 market introduction of our next-gen Zio MCT system. Given the additional time, our strategy regarding the Zio MCT system enhancements has shifted such that we intend to move directly to Zio MCT 2.0 by pulling additional product design features into our initial submission that we had previously planned for a later generation. We will continue to evaluate options to expedite our product timelines and ensure that we can bring innovative technologies to market as quickly as possible. In closing, I could not be prouder of the iRhythm team.

The teams will remain focused and committed to the goals that we laid out at the beginning of the year despite the potential of being easily distracted and have achieved outstanding results to date. We delivered tremendous growth in the first half of 2023 and are making the necessary investments into the business to continue driving growth through multiple levers in an operationally efficient manner. We continue to believe that the global ambulatory cardiac monitoring market will grow significantly in the coming years and we are well positioned to capture our share of this sizable opportunity ahead. We’ve never been more excited about the future of our company. With that, I’ll now turn the call over to Brice to discuss our financial performance.

Brice Bobzien: Thanks, Quentin. As a reminder, unless otherwise noted, the financial metrics that I discuss today will be presented on a non-GAAP basis. Reconciliations to GAAP can be found in today’s earnings release and on our IR website. As previously mentioned, our second quarter results demonstrated significant momentum in our core U.S. market as we realize revenues of a $124.1 million or 21.6% year-over-year growth. Looking at new store same-store mix, new store defined as accounts that have been open for less than 12 months, accounted for over 30% of our year-over-year volume growth. This was driven by the second quarter being the second highest quarter ever of Zio XT new account openings while we also continue to increase penetration in existing accounts and reduced account churn.

Home enrollment for Zio Services was approximately 20% of volume in the second quarter. Average selling prices during the second quarter were in line both year-over-year and quarter-over-quarter, with pricing stable within the commercial portfolio and national rates in place for our Medicare business. As of the beginning of 2023, we have continued to leverage our IDTF footprint in the most efficient manner to serve our patients. After the second quarter close, CMS did release proposed updates to their calendar year 2024 physician fee schedule that included relatively minor reductions to the physician conversion factor used to calculate payments for all CPT codes, as well as proposed clinical labor cuts to relative value units for all CPT codes.

However, the proposed rule also incorporated an increase in San Francisco’s geographic practice cost index modifier. Thus, we believe the net impact of the CMS calendar year 2024 proposed rule will be immaterial to iRhythm’s business as we understand it today. As this is only a proposed rule at this point, we intend to proactively engage with CMS and industry groups until the rule is finalized in the November timeframe. Longer-term, we intend to continue to work with CMS and other stakeholders to properly understand the value of AI and innovative medical devices such as the Zio Systems. Moving down the rest of the P&L, gross margin for the second quarter was 69.5%, representing a 160 basis point improvement compared to the first quarter of 2023 and a 70 basis point improvement versus the second quarter of 2022.

Both sequentially and year-over-year improvements were driven by a reduction in unit cost to serve as we ramp volume significantly and continue to leverage our fixed cost infrastructure. Second quarter adjusted operating expenses were 99.7 million, down 9% sequentially and up 7% year-over-year. Sequentially, decreased spend was primarily driven by seasonal items in the first quarter that did not reoccur in the second, such as timing of payroll taxes, as well as annual sales and leadership meetings, slightly offset by higher personnel expenses to support growing volumes. Also, as expected, some of the duplicative costs incurred during the first quarter of 2023, starting to slow down as we operationalize the global business services center in the Philippines and begin to leverage third parties.

Compared to the second quarter of 2022, the increase in adjusted operating expenses was primarily due to payroll-related expenses to support the business’s significant volume growth. Particularly encouraging is that SG&A as a percentage of revenue was dramatically reduced compared to the prior quarters, led sequentially by the benefit in G&A leverage. We believe that this is a trend that is sustainable over the long-term as we begin to realize value from our focus on operational efficiency. Adjusted net loss in the second quarter was $13.1 million or a loss of $0.43 per share compared to adjusted net loss of $33.4 million or a loss of a $1.10 per share in the first quarter of 2023. Year-over-year, we saw a $0.36 improvement in adjusted net loss per share as we continue to drive operating leverage in our core business.

Second quarter 2023 business transformation costs were $5.4 million, generally in line with expectations as we continue to stand up our global business services center. Importantly, adjusted EBITDA in the second quarter 2023 was positive $4.4 million, reflecting an increase of $16.4 million sequentially and an increase of $9.3 million year-over-year. You can clearly see the momentum building in the organization as we put greater focus around operational efficiency. Turning to guidance. We are updating our 2023 outlook to reflect the anticipated full-year revenue growth of approximately 18% to 19% compared to 2022, representing a range of approximately $485 million to $490 million. This takes into consideration our performance in the first half of 2023 and seasonality typically seen in the third quarter while also remaining thoughtful as we continue to navigate the remainder of the year.

We anticipate approximately 25% of full-year revenues to be realized in the third quarter in line with non-COVID years. We continue to believe that gross margin will range between approximately 69% and 70% for the full-year. As previously detailed, our full-year guidance contemplates pressure to gross margin in the back half of 2023 as we ramp to launch our Zio Monitor Services into the U.S. commercial marketplace. This will include an evaluation of our current XT inventory levels and may reflect underutilized cost for our Zio Monitor System as we scale the new product. We continue to anticipate that adjusted operating expenses in 2023 will range between approximately $417 million and $427 million. Notably, our adjusted operating expense guidance now contemplates costs associated with the FDA engagement and the Department of Justice inquiry.

However, we’ve been able to drive efficiencies in the business that will offset these incremental increases for the remainder of the year. With the update to revenue guidance and the efficiencies created with an operating expenses, we now believe that adjusted EBITDA margin in 2023 will range between approximately 0% and 0.5% of revenue. As a reminder, adjusted EBITDA will continue to exclude restructuring costs, transformation costs, and stock-based compensation expenses. In 2023, we continue to anticipate incurring approximately $15 million to $20 million of one-time non-GAAP business transformation and restructuring costs related to the ongoing globalization efforts to drive efficiency, improve scalability, and provide continued high-quality customer and patient experience.

We believe that the expenses incurred related to these activities in 2023 will further enable operating leverage into the future, especially as we grow to serve more patients in our core markets and internationally. Finally, we ended the second quarter in a strong financial position with $164.7 million of cash and short-term investments to drive continued growth in our core business, invest in innovation and lay the foundation for future expansion. With that, Quentin, Dan and I would like to now open the call for questions. Operator?

Q&A Session

Operator: Thank you. [Operator Instructions] We request that each person limits themselves to one question and one follow-up. Thank you. Our first question today comes from the line of Margaret Kaczor from William Blair. Please go ahead, Margaret. Your line is now open.

Margaret Kaczor: Hey. Good afternoon, guys. Thanks for taking the question. Maybe just to start, I wanted to see if you guys can give any breakdown in terms of growth of XT versus AT this quarter. And I referenced that in part because of guidance, right? So we saw guidance on the low end, up $5 million. You obviously had a really nice beat this quarter, at least relative to our numbers. You’re talking about near record new account adds, national accounts, we’re seeing the accelerating growth. So long story short, I’m trying to understand, why not raise the high end of the guidance range? I know AT was part of that in the past, and we’ll get you.

Quentin Blackford: Sure. Hey, thanks for the question, Margaret. Look, I think overall, we continue to be really encouraged with momentum in the business on both the XT and the AT business for that matter, with AT continuing to step up off of where it was at in Q1. I’ll let Brice get into some of specifics around exactly how the two figures grew within the quarter itself. But in terms of the full-year, I think more than anything else, we are not going to get ahead of ourselves at this point in time on the high end of the guide. Certainly, we’re ahead in Q2. We’re very bullish with respect to the momentum that we’re seeing. But going into the back half of the year, we want to be thoughtful about it. So there’s nothing to read into there, but I’ll let Brice speak to the results of the quarter.

Brice Bobzien: Yes. Margaret, good question. And we’ve talked about this in the past. I think from a registration perspective, we’re seeing pretty significant growth across both lines of business. When you think about the AT component, it’s in that high-30s range that we’ve talked about in the past. And you can think about then where that meets from an XT perspective, it’s north of the 20% range. So we feel great about the progress being made and where we’re at operationally to Quentin’s point. We just need to be thoughtful as we navigate the back half of the year and make sure we’re not getting ahead of ourselves.

Margaret Kaczor: Okay. That’s helpful. And then the second thing I wanted to touch on a little bit is, the warning letter. In your comments on the label changes, the FDA is requiring to kind of leave the product on to the market. So that, one, did I understand that correctly? You will be able to leave kind of AT on the market. And then two, what’s the impact of that label change that they’re asking for? Does that limit your ability to sell it all or add new accounts or anything of that sort? Thank you.

Quentin Blackford: Yes, Margaret. That is the right way to think about it. We work through with the FDA sort of our suggested labeling changes. They’ve had some adjusted labeling changes as well to which we’re in full alignment with, and we’re in the process of working those into the label as we speak. And most of that is just around clarifying more clearly for the patient and the physician, matters around trigger limits, duration of the life of the product, those sort of things. So it’s nothing that’s going to impede our ability to sell the product or market the product. And to your point, yes, we’ve reached alignment there that, we can continue to monitor or, sorry, market as an MCT monitor into the future.

Margaret Kaczor: Perfect. Thanks, guys.

Quentin Blackford: Thank you.

Operator: Thank you. The next question today comes from the line of Allen Gong from JPMorgan. Please go ahead, Allen. Your line is now open.

Lily Lozada: Hi. This is actually Lily on for Allen. Thanks so much for taking the question. Maybe just following up on that. Could you just talk a bit about the trends you’ve been seeing in Zio AT in light of the warning letter? Have you seen that result in any sort of softness in demand since that was announced?

Quentin Blackford: Yes. I think for the most part over the course of the quarter, keep in mind that the warning letter came in the latter part of it. So we were very proactive to get out with our customers to address the fact that there was a warning letter to speak to exactly where the focus was at and make sure that we were proactively engaging with our customers. And I I’ll tell you, we’ve been really encouraged by the results that we’ve seen in that AT business, even post the warning letter. So momentum continues to be strong. I think we’re as excited as ever about that product line. To Brice’s point earlier, we’re going to be thoughtful about it in the back half of the year. The comps do get a bit easier with AT in the back half considering, we had the challenges with it in the fourth quarter of last year.

So the setup is nice, but we’re just not going to get ahead of ourselves at this point with respect to the high end of our guidance. But with AT, incredibly bullish on it. We think there’s a tremendous amount of market share to be gained in that MCT space. We think the AT product is differentiated. Certainly, we’re excited to get the next-generation of our MCT device out there, but there’s a lot of runway in that space and the momentum continues to be very strong in our business there.

Lily Lozada: Great. That’s helpful. And then maybe just on the DoJ inquiry. Is there anything new that you’d be willing to share in terms of what they’re actually looking into? Any timelines we should be keeping in mind and how you’re thinking about this impacting the business? Thanks so much.

Quentin Blackford: Yes. With respect to the DoJ, not a whole lot to update on at this point in time, I mean, we are producing documentation for them. It’s hard to get any real clarity on exactly what the area of focus is. I would point back to, we believe we’re not the only one in the industry that received the document request or the subpoena knowing that one of our competitors in the MCT space also received that. So we’re complying with them. We continue to cooperate with them. The interactions have been very cordial. We’re going to continue to work directly with them. But in terms of giving you a timeline around what to expect, it’s hard to say. I really don’t know what to share with you there. As we have updates, we’ll be committed to updating the investor community as we have those. But at this point in time, there’s just not any new information shared.

Lily Lozada: Got it. Thank you.

Operator: Thank you. The next question today comes from the line of Kallum Titchmarsh from Morgan Stanley. Please go ahead, Kallum. Your line is now open.

Kallum Titchmarsh: Thanks, guys. Just one on international from me, if possible. So obviously, good development here in Japan. Can you maybe talk a bit more about this and how we should think about modeling the ramp out here over time once approved, and I guess relative to what we saw in the U.S. relative to the launch there? Thanks.

Quentin Blackford: Yes. We’re super excited about what we’re seeing in Japan. I think capturing that high medical needs, designation is a meaningful milestone for us. And I think most importantly, the fact that it’s specific to Zio and not long-term monitoring in general is even more encouraging to us because it creates some real differentiation for us in a market that frankly hasn’t valued patch-based technologies just yet. And then to have, differentiated within that group is significant. We’re on file now as we identified with respect to the Shonin application. I think that probably runs 9 to 12 months is our best estimate, and then we’ll immediately go into discussions around reimbursement, which is probably another six months.

And certainly, having the high medical needs designation, I think, puts us in a position to really push for premium pricing in that segment. I think it’ll be very attractive pricing for us in that market, which again is the second largest market in the world more than 1.5 million ACM test being prescribed each and every year. But when you think about timing of contribution, I think, you probably see a product coming into the market late in 2024 as we turn into 2025. So we’ll speak more around what to think about in the way of contribution as we get more clarity on when it will be available to come into the market, but probably not a revenue driver for us in the year of 2024, but a product that begins to come into the market early 2025.

Kallum Titchmarsh: Got it. And then maybe just one follow-up, please. So just on penetration of Zio in the U.S. ACM market, there are quite a few numbers out there at the moment. Maybe it would be helpful if you could break down and quantify where you think penetration sits right now. I guess relative to the traditional Holter devices and then any impact you’ve seen from the emergence of compelling products that might have changed the rate of penetration?

Quentin Blackford: Yes. I think that penetration rate sits somewhere right around 30% of the overall market utilizing patch-based technology. So I think there’s a meaningful runway that continues to sit in front of this entire industry. I think we have the fair share of that 30%. I think we have the best-in-class product that’s out there certainly CAMELOT, the data that we released earlier in the year would validate that. And back to the point that you got a long runway in here as these patch-based technologies become the standard of care in this industry. And I think that’s going to fuel significant growth, not only for ourselves, but for our competitors as well. I think the rising tide is going to lift all boats in this scenario, and that’s going to be the case for several years.

I think where it gets really exciting is the progress that we see around the primary care physicians utilizing this device to a meaningful degree and the interest level that continues to grow there. The bigger question is does the overall market grow significantly with this technology considering how easy it is to use. And I think that becomes the real opportunity where you can more than double the overall size of this market over the next several years. So you’ve got two things working in your favor. You’ve got early adoption of the technology as it moves the sort of standard of care, and then you’ve got the opportunity to really meaningfully increase double, if not triple the overall size of the market.

Kallum Titchmarsh: Got it. Thanks a lot, guys.

Quentin Blackford: Thank you.

Operator: Thank you. The next question today comes from the line of Marie Thibault from BTIG. Please go ahead, Marie. Your line is now open.

Marie Thibault: Hi. Thanks so much for taking the questions and congrats on a great quarter. Wanted to ask here a clarification on the FDA warning letter process. I think I heard you say that in your discussions with the FDA, you’ve also proposed enhanced design features and are still determining the potential need to submit a 510(k). Any clarity on the sorts of timelines you’re thinking about with the agency, anything that they’ve communicated on that front, and just wanted to understand those proposed enhanced design features. Certainly understand MCT is a separate thing, but just wanted to learn a little bit more about that.

Quentin Blackford: Yes. Hey, Marie, thanks for the question. With respect to the letter to file or would they like to see a catch up 510(k), that is something that’s still in the review with the CDRH and therefore, the FDA. And I’ll tell you that the collaboration there has been terrific. A lot of great dialogue and back and forth there. And they certainly are looking at our letters to file and getting comfortable with whether that was an approach they’re okay with or if they would like see us move to a catch up 510(k). In terms of the time frame around that, I can’t give you any specific timing around it other than it’s the active part of their review right now, and we’re in the midst of it. So it could be quick.

It could take a bit longer. The way we’ve thought about the Zio MCT in those time frames, frankly, is that it’s going to take a bit of time to work through this with them and that there maybe a catch up 510(k) that’s required of which we’re highly confident that we would be able to continue to market the product and leave that agency product in the marketplace while we work through a catch up 510(k), but we would need to get that through the FDA, and then we could submit MCT. So when we talk about the delay in the MCT product, a lot of that is sort of contemplating navigating through this with the AT product and the FDA. So that’s what’s impacting those time frames a bit. With respect to the design features, they’re relatively straightforward.

It’s identifying the capability to put on the patch itself away to notify the patient when they might be approaching that match trigger limit. So think about that as a light that begins to flash on the device itself. It’s working into, say, Zio Suite, a trigger limit counter, so that as you’re approaching it, you start to see that. So these are relatively easy design enhancements that we’ve identified and are working with the FDA on, nothing that changes the features functions of the product in any way or how we would sell it. But just it’s more informative to the patient and the physician. So that’s how we think about it. And of course, as I said, when the FDA sort of clarified if they’re okay with our learn to file approach or if they’d like to see us, file a catch up 510(k), we can provide more information at that point in time, but we feel good about the interactions, the date, the tone and the interactions, and exactly how we can continue to navigate forward with this and the product staying in the market throughout that process.

Marie Thibault: Okay. That’s well understood. Thanks for all that detail, Quentin. My follow-up here is on Zio Monitor. Good to hear all the really positive feedback coming out of that product. How are you thinking about the phase launch? Should we be in a broad launch by the end of the year? And how should we be thinking about changes in return rates or any uptick in prescribing? Any ways to think about that new enhanced product? Thank you.

Brice Bobzien: Yes. Marie, we’re super excited about these monitoring being market place. And that launch will start here in the back half of Q3 and we’re really excited to get it into our patients and our customers’ hands. And it will continue throughout the remainder of the year. As you know, these things take a bit of time as you’re pushing them out into multiple channels and multiple different customers, but we’re really excited. As far as contemplation of any improvement in the return device rate, we haven’t necessarily thought about it thus far. It’s going to take some time for it to be out there and start to be utilized and frankly for it to come all the way back through the system. So nothing contemplated from a guidance perspective.

So any benefit that we would get, and we do believe there’s a benefit over time is not contemplated in the guidance that stands now. We also have not contemplated any incremental volume associated with the Zio Monitor Launch. Penetration levels, ramping volumes, those sorts of things have been performing incredibly well with XT. Do we think there’s an opportunity for that to be enhanced with monitor? Absolutely, there is, but that has not been contemplated in the guide as it stands now.

Marie Thibault: Okay. Very good. Good luck with it. Thank you.

Quentin Blackford: Thank you.

Operator: Thank you. The next question today comes from the line of Richard Newitter from Truist Securities. Please go ahead, Richard. Your line is now open.

Samuel Brodovsky: Hi. This is Sam on for Rich. Thanks for taking the questions. First one to put a finer point on AT as it’s contemplated in the guide. Is it reasonable to expect and does guidance expect an acceleration in year-over-year growth for AT in the second half, given that those comps get easier?

Quentin Blackford: Yes. So the comp definitely gets easier. The way we’re thinking about it is we’re keeping it in line with what our original expectations were, and a 100%, there could be – it is on some easier comps, so we could see accelerated growth there. But we want to see it play through the numbers before we get out ahead of ourselves. So that’s the way we thought about it. Really no adjustment to what we had originally assumed from the original guidance.

Samuel Brodovsky: Got it. That’s helpful. And then second one, just on cost and impressive margin result here in the quarter. And as we think about some of those costs coming out, how sustainable could they be? And as we think about 2024 with some of these, hopefully, one-time costs coming out with the DOJ and warning letter. But actually think about leveraging the business into next year. Thank you for taking the question.

Brice Bobzien: Yes. So gross margin in the quarter, we’re really happy with the results. 69.5% coming off a quarter of 67.9% in Q1. So nice improvement from a sequential quarter standpoint. Honestly, to your point, there’s some duplicative costs that were in Q2 or Q1. And some of those came out in Q2, but there are still others that are there. And a lot of that is just creating efficiency in these areas of focus that we’ve had. And that’s being leveraging some third-party resources for our customer care and our clinical ops side as well as standing up the global business center in Manila. So there is some duplicative cost still in the system, but we did see it start to tail down. I, for me, as I think about gross margin, I – we talked about the Zio Monitor Launch being a bit of a headwind in the short run because we have to evaluate the XT inventory levels, and that’ll take a while to get the scale.

So, as you’re thinking about the model, I think, gross margin probably pulls back a little bit in Q3, but spend, I think, spend is a $100 million or so. It’s going to be relatively consistent. Now there will always be some volatility, and that’s why we put out the range of 417 to 427. And you’ll work that into your model. But I do think over time, this is absolutely sustainable. It’s just going to take a few quarters for us to fully have those new operations up and running, and until we really see it play through. We’ll talk more about 2024 as we move throughout the year, but, we feel great about the trajectory we’re heading.

Samuel Brodovsky: Thanks for taking the question.

Operator: Thank you. The next question today comes from the line of Nathan Treybeck from Wells Fargo. Please go ahead, Nathan. Your line is now open.

Nathan Treybeck: Hi. Thanks for taking the question. Just to clarify on the warning letter, is there any change to your marketing claims at the moment for Zio AT as an MCT device?

Quentin Blackford: No. No. There’s further clarification in the label itself, as I indicated earlier, just to help and enhance the understanding for the patient, but there’s no difference in how we’re marketing the device and we’ll continue to market it as an MCT device.

Nathan Treybeck: Okay, great. Thanks. And in terms of – so what can you comment on the next-gen Zio MCT that you will kind of bring it to the market due to the submission delay? Will this be a 30-day device? And anything you can give on the next-gen device? Thanks.

Quentin Blackford: Yes. So great question. The first generation of the MCT device was certainly looking to extend the wear period out beyond the 14 days that’s in our AT product today, getting north of 20. By going to the 2.0 version, it does start to introduce capabilities like utilizing a smart device versus our gateway that we use today. When you introduce that, it now starts to open up opportunities to go even beyond 21 days, get out closer to that 30 days, if not 30 days. So, yes, it opens up that feature set, opens up things like making information more available through the smart device, on a more timely manner, to inform a patient, to inform a physician. There’s just a lot of things you can do through a smart device.

Now there are some other things that we’ll bring into the product itself that we’re not going to disclose at this point in time more for competitive reasons, but I think there are some real differentiators that we had planned originally in the second generation of MCT to be delivered after the launch of the first generation, we’ll now pull that forward. So as we get closer to submitting that and ultimately getting that through clearance, we’ll start to talk about some of those enhanced features. But we’re excited about MCT, I think it’s a tremendous opportunity for us in the future.

Nathan Treybeck: Great. Thanks.

Operator: Thank you. The next question today comes from the line of David Rescott from Baird. Please go ahead, David. Your line is now open.

David Rescott: Hey, guys. Thanks for taking the question. Congrats on the strong quarter here. Just first on the Zio MCT extended timeline here. I just have a two-part question. One, wanted to clarify that what your talking about with the Zio kind of MCT 2.0 is essentially more of just an enhancement that’s coming in 2025 and there’s not a new device coming between the proxy of now and Zio MCT? And then the second part to that question, I’m just wondering if the extended timelines here impact the kind of five-year 20% growth outlook that you have or the way in which you’ve kind of described that that you get there. I think you previously talked more about linear growth and just wondering if the timelines here impacts that at all?

Quentin Blackford: David, thanks for the question. I don’t see it impacting our path to where we’re trying to get over the five years to a $1 billion in revenue. I don’t see it impacting that at all. I think we continue to be encouraged by the momentum in the AT business. It’s growing very nicely for us. I do think, there are some things we can even do on that AT product. Before we get to the next-generation of the MCT device that we will bring to market that can continue to enhance it. So I don’t see any change to the long-term trajectory of what we’re taking the business and getting to the $1 billion in revenue and the time frames that we talked about. There will not be another device that will get introduced between, say, AT and ultimately getting to that MCT what I’m now calling 2.0, but it will really be our initial version of our Zio MCT product into the market.

It’s just we’re bringing features that were originally in the second generation forward into that first generation. Now I think it’s important to note, we were within a matter of weeks, a month or so of being able to submit our Zio MCT product with the FDA or approval of sort of that first generation device. The reality is we navigate through the warning letter with the FDA, and we want to make sure we address all of their concerns appropriately, our focus is on AT with them. And we’re not going to focus on anything other than AT with the agency until we get them comfortable, and we feel like there’s a clear path there, but we want to navigate through that before we introduce MCT as a filing. So we’re really happy with the progress on MCT.

We’re excited by it. A lot of that first generation is designed. Now we move on to designing in some of those second generation features while we continue to work with the agency on AT. And at the end of the day, it speeds up our ability to get an even better product into the market.

David Rescott: Okay. Makes sense. I guess, just on the warning letter then, I think you said, you talked about kind of the clarification around the label changes. I’m just wondering, based on what you submitted, if the FDA essentially has accepted these clarifications and maybe the risk that we’ve all kind of thought about for the device to maybe come off the market, has been removed or if that kind of risk is more or less off the table at this point just based on where you are in the discussions with the FDA on the warning letter. Thank you.

Quentin Blackford: Yes. And I think, look, out of respect to the agency, we realized that the review is still open, right? And anytime the review is still open, the agency could go any direction that they want to. So your initial question, have we aligned with the agency? We absolutely have with respect to the labeling requirements that both, one, we have suggested some updates and they suggested some updates. We’ve absolutely aligned with them on what those labeling changes need to look like, but we’re putting those into the label as we speak, and there’s alignment there that with those labeling updates, we can continue to market the product as an MCT device. So there’s alignment there with the agency. The part of the review that we’re not through yet is they’re digging into the letter to file.

They’re looking into that. And ultimately, they’re going to have to get comfortable that either the letter to file approach that we took is one that they’re comfortable with. We continue to believe that it was the right approach. We’ve had external experts and consultants look at this as well that, align with our point of view around letter to file, but we respect the fact that that the agency could have a different point of view. And if that’s the case, then, likely would run down the path of sort of a catch up 510(k) to where you would put those letter to file changes into, you know a catch up 510(k) to get it on file. In that scenario, we continue to believe that the product would stay in the market and that we would continue to market the product and there would not be any disruption with it.

And my view is, we’ve had multiple months of interaction now with the agency if they were interested in halting the product or delaying, marketing of the product, seizing shipment of the product, they would have made that clear in the warning letter, or they would have begun to make that clear in the interactions that we’ve had with them to date. And there’s nothing in those interactions that give us any indication that that is where they would go with this. As a matter of fact, the fact that we’re raising the midpoint of our guidance, I think, should infer the confidence that we have in the interactions to date and sort of the fact that we’re pleased with where this has gone thus far. So we continue to be excited about the future, continue to believe we can navigate through this in a very successful way and that the product will remain in the market throughout.

David Rescott: Great. Thank you.

Operator: Thank you. The next question today comes from the line of David Saxon from Needham. Please go ahead, David. Your line is now open.

David Saxon: Yes. Good afternoon, guys, and thanks for taking my questions. I wanted to start with reimbursement, maybe a two-parter here. Maybe first, just give an update on where you are with transferring volumes to your SF IDTF. And then secondly, maybe can you just remind us what you’ve seen historically in terms of, changes at commercial payers. We obviously see what CMS is proposing, but I think it’d be helpful if you could frame what commercial rates have done, as contracts renew?

Brice Bobzien: Sure. So as far as the progression to the San Francisco IDTF, I would say we’re operating in line with our expectations. We still believe that roughly 50% of our total volume in 2023 will run through that San Francisco IDTF. So I think we’re progressing well. And again, we’ll continue to bring the investor community up to speed should anything change from there, but we’re operating in line with what the plan was. As far as the reimbursement side, you probably saw the announcement on the CMS side for calendar year 2024. And there were some small reductions contemplated in the proposed rule. And with some small changes to the physician conversion factor, the clinical labor reductions for relative value units across all CPT codes.

In our mind, that’s probably about a 4% to 5% reduction in the reimbursement for CMS with those two impacts. As importantly, I think you probably saw the San Francisco, geographic modifier being increased by about 2%. So as we think about it, that’s 2% to 3% net-net on 25% of our business immaterial from our perspective. So it is a proposed rule. We’ll certainly continue to work with CMS and provide as much information as we can as to why we should continue to look at these and maybe a reduction isn’t necessarily necessary, but that’s a relatively small reduction. As far as the commercial pricing goes, we’ve said low single digits from the beginning on that guided to it. And we’re landing right in that sweet spot and right then that range.

There are a few commercial payers that do follow CMS pricing. Those would be incorporated based on this 2024 proposed rule. Again, it still falls into that low single-digit range. So no deviation from what our expectations would have been originally.

David Saxon: Okay. That’s super helpful. Thanks for that, Brice. And then, I guess as a follow-up, I haven’t heard anything on the Zio Watch, so maybe just give an update date on how you’re thinking about pilot timing and kind of monetizing that product. Thanks for taking my questions.

Quentin Blackford: Yes. Great. So with respect to the watch, again, development teams continue to make progress in and around that. Our focus has here in the near term turned entirely to the AT product and just navigating through the questions that were posed there, I would expect we’ll be in pilots, probably more the turn of the New Year and into the very beginning of next year, but progress is being made there. And I’m excited about what the watch can bring over time.

David Saxon: Great. Thank you.

Operator: Thank you. The next question today comes from the line of Bill Plovanic from Canaccord. Please go ahead, Bill. Your line is now open.

John Young: Hey, everyone. It’s John on for Bill tonight. Thanks for taking our questions and congrats on the quarter. Maybe I could go to the PCP side. I know you commented that, continues to be strong. You’re seeing a lot of success there. But could you provide any, metrics around that? Maybe talk about the high number of new accounts you opened in Q2, how many of those were from PCPs. And just talk about how the commercial field force may be dividing its time between the two opportunities. Thanks.

Quentin Blackford: Yes. I don’t think we’ve given any specific color around exactly what percent of the new accounts are coming from PCPs, and that may be something that we’ll look to disclose further into the future. I can tell you we’re having a lot of good success in that segment of the market. We’ve spoken about some of the new national accounts that we’ve brought on board. Many of those are primary care focused national accounts, if you will. And so really excited about the the success that we’re having there and maybe more importantly, the interest that continues to build around that model. I think there’s no question in my mind that primary care is where the majority of the application of this patch is going to happen in the future.

It’s just – it’s so easy to use and the benefits are so significant benefits beyond even sort of diagnostic capability with the patient, but workflow benefits that that these networks, these IDNs are beginning to see. And I think it kind of hits on your question of how are the reps devoting their time? Well, a lot of the success we’re having in the primary care channel frankly comes from the accounts that we already have a relationship with where we were dealing with the cardiologist or the EP, the specialist. They see the value of having this device placed much earlier in the care pathway by the primary care physician, which then helps them identify who do they really need to spend time with? Do they need to schedule an office visit with a patient or not?

And they will make that determination based upon what they’re seeing in the report coming off of the Zio patch. So you see a lot of these existing accounts now having the primary care specialists within their network, prescribe the device, and then they’ll look at the report and Zio Suite make a determination. So in terms of refocusing a sales reps, time or call point, not a whole lot of that at this point in time. They’re focused on the specialist, these networks where we can go deeper into the channel. And then we’ve got a large national, sort of national accounts team that’s really focusing more at that national level to go broad across these big strategic players like the one medical that we’ve announced in the past, that allow us to come from a top down approach.

So a lot of great progress. I’m incredibly excited about where this is going to go in the future.

John Young: I appreciate all that color. Thanks. And then maybe just as my follow-up. Any update on the Know Your Rhythm program? I know you spent a lot of Investor Day talking about this the – the at risk model and the asymptomatic opportunity, especially with the CAMELOT data that you have now. Just any updates around that program would be great. Thanks.

Quentin Blackford: Yes, continue to have a lot of discussions in and around it. I would expect, we’ll be in formal pilots here in the third quarter with some of these parties. But I think we’re also seeing that the Know Your Rhythm, as we defined it historically around that asymptomatic population, quite honestly, it’s starting to branch beyond that. It’s more about an undiagnosed population, and we’re seeing this in the interest of payers where they’re starting to see connections, say, in disease state that go beyond just arrhythmias, but how does an arrhythmia connect to, say, a diabetic population or a COPD population or hypertensive population or sleep disease. They see these connections and the idea is, where we see those connections in medical records, can we identify populations that have been undiagnosed with arrhythmias that can increase the opportunities to find those things and then better treat those patients and therefore reduce cost downstream.

That’s getting a lot of discussion and a lot of track at this point in time in terms of identifying ways to validate that, put pilots in place, and ultimately open up those markets. So I would tell you, we’re very excited about Know Your Rhythm, although I think it is broadening a bit in terms of how it’s being defined today or how we see it growing versus maybe how we defined it earlier around just the asymptomatic population. So it’s growing a bit.

John Young: Great. Thanks so much.

Operator: Thank you. The next question today comes from the line of Suraj Kalia from Oppenheimer. Please go ahead, Suraj. Your line is now open.

Suraj Kalia: Good afternoon, Quentin and Brice. Can you hear me all right?

Quentin Blackford: Yes. We can hear you, Suraj.

Suraj Kalia: Perfect. Hey, Quentin, congrats on the quarter. Quentin, many calls going on, so please forgive me if this is redundant. I must have missed it. Specifically going back on Zio AT, Quentin, I just want to make sure I heard your comments about labeling changes. But if you recall, the warning letter was also talking about misbranding. So I just want to make sure you’re all, there is a clear understanding you all can bill Medicare as MCOT. With the event trigger thresholds or throttles, that is status quo, there is no change, there’s not going to be no surprise on the – a few months down the line on that aspect.

Quentin Blackford: That’s correct, Suraj. So, as we work through this with the agency around the labeling updates that, again, some that they’ve suggested, some that we’ve recommended and they’ve aligned to, and we’ve certainly aligned to their recommendations. And we’re in the process of making those updated labeling changes, which again, are really informing the patient more clearly and the physician more clearly around the device and the features of it, not changing any of the features of the product at all, we can continue to market that device as an MCT device. And now keep in mind, the FDA does not make determination around what you can bill or how you bill, right? That’s an AMA billing code question, but I will tell you we feel very comfortable that we meet the requirements of AMA’s definition of MCT as well and also the very clear requirements in the billing code for MCT.

So in our mind, nothing changes there at all. We continue to see AT as an MCT product and we’ll continue to market that way.

Suraj Kalia: Fair enough. Quentin, in terms of pressure points in the field, for your next-gen 2.0 MCT, 30-day 24/7. I go with the assumption, this is going to be, like, real-time 24/7. Obviously, the business model by your competitors versus iRhythm is completely and fundamentally different. Should we think about any aspects of shared economics with Zio MCT that you’ll envision rolling out in the future, more specifically, just given the centers really don’t make any money on MCT with the Zio approach.

Quentin Blackford: Yes. I don’t know why the approach with Zio is any different than any competitive approach. Zio AT is an MCT product. It works very similar to any of the competitive products. Yes, we have the trigger limit, which is in our product by design to address battery life issues. And, frankly, as a patient or a physician would approach the trigger limit, we would send a second device to replace it. It’s no different than a competitive product that has a battery limit issue. When their battery dies, they’re no longer recording. They have to take that off and recharge it or put a new patch on. So it’s no different than the competitive devices that are in the market today. We position ours as 14 days. We believe that the data that you can get off that 14 days is very valuable and as good as anything you’re getting off of a traditional MCT device, but there are opportunities for us to extend the wear period into the future.

But in terms of competitive positioning, how we’re going to position the new MCT product. I don’t see it a whole lot different than AT. This has got some enhanced design features to it that continue to differentiate it within the marketplace and we’re excited by that.

Suraj Kalia: Forgive me, Quentin, I should have rephrased. What I meant was the professional and the technical fee collection by on the MCOT side is, you guys collect the $800 or so in Medicare. On the other side, it’s not collective, it is collected by the cardiologist, right, and that’s the economics I was talking about. If there could be some aspect of shared economics eventually, when 2.0 is rolled out?

Quentin Blackford: Yes. I think, look, as we get closer to rolling out 2.0, we can talk about how we’re going to position it in the market or if pricing were to change in some fashion, then I suppose we could talk about that. I don’t envision that at this point in time. And that’s getting into something that we probably would discuss more of that closer to that launch date if we were to think differently on how we would position it in the marketplace.

Suraj Kalia: Fair enough. Gentlemen, thank you for taking my questions and congrats again.

Quentin Blackford: Hey. Thanks, Suraj.

Operator: Thank you. The next question today comes from the line of Mike Polark from Wolfe Research. Please go ahead, Michael. Your line is now open.

Michael Polark: Hey, good afternoon. Thank you for taking the question. I wanted to pick up the Know Your Rhythm thread and broaden it and ask for a reminder on something as impactful as like USPSTF kind of a full unlock of screening. Is there a path there that you can articulate today with the kind of two, three, four-year horizon, or is that kind of a dream at this point? I know there’s obviously been tons of evidence generated over a long period of time, but one of the major trials that was positioned to answer the question USPSTF was wanting to be asked or answered GUARD-AF kind of fell short on enrollment and so might be underpowered. And so just where does this all stand today? And then what are the next steps with the – with an organization like that?

Quentin Blackford: Yes. Look, we certainly will continue to work with the USPSTF around getting them to identify the need for proactive screening. I think that’s an important part of the future opportunity here and certainly open stores more readily, although I don’t think you necessarily have to have that to open the doors with commercial payers. And, look, the USPSTF typically works on cycles, right? It’s not every year that they’re reviewing these sort of things. But to that point, we expect there’s going to be data out later this year, economic data around the mSToPS study. I think you’re going to see some incremental information coming out around GUARD-AF. We’ve already seen some of the economic data that’s been presented around Zio, in particular, in terms of the quality adjusted life year and sort of the economic value of that, which came back very, very attractive.

$17,000 for quality adjusted life year, we know that when you start to get less than 50,000, it becomes very, very attractive to payers. And frankly, it’s capturing a lot of attention, as we sit in front of payers with it. So folks are paying attention here. This is not something that we’ve put on the back burner and not focused on, but to move the USPSTF, it takes time, and they work on cycles. So we will continue to work with them, but we’re going to continue to pull data together, that makes the case for the value of this device delivers.

Michael Polark: Helpful. My other one is on international and I know it’s early days in small numbers and all that. But, like, so something like Japan, is that a country where you build a local IDTF or you leverage what you’re doing in Manila or a little of both and maybe in Europe as an example as well as you start to open up more European markets? Are you building local IDTF support or using Manila or a little bit of both? I’m just curious how this kind of evolves and cross-border or intercountry service support, what the vision is. And one more piece of this, are any of these countries places where you might want to go in as kind of a product-first company as opposed to a product enabled service company. Thank you so much.

Quentin Blackford: It’s a good question, Mike. Actually, it’s a great question because I think, those are the very things that we navigate through on a daily basis as we think about the international opportunity. And the reality is every country is a bit unique and different. And early on, those countries that we believe can leverage, say, the UK stack that we’ve put in place and already built, those are sort of higher up on our areas of focus just from the aspect of being able to move with speed. Over time, we’ll continue to build out capabilities that meet local requirements, particularly around privacy that’s very important to us and very important to our patients. But we want to make sure we can meet those needs before we could go into any one of those markets.

So all of that comes into consideration as we think about, which markets we go into first. I mentioned, we’ll get started here in Switzerland here in the very near-term. Spain, Netherlands are next on that list in terms of ease to get into the market and really start to evaluate the product there. Japan, we’re on file from a regulatory perspective. We’ll build out capabilities there locally to a degree, but we’ll also leverage those across the company that we can in a way that is compliant with Japanese requirements. So those are still things that we’re working through with the local administrators in that country. So all of that will define more clearly as we get closer to commercial launch, but I think we’ve got a clear path here.

And your question is the right one, but every country is just a little bit unique and different than a different pathway for each one maybe required. Some of those will leverage infrastructure, although we might have to build a bit ourselves. In terms of a country where we go product-first versus services, those are certainly things we’re looking at as well. So not going to get ahead of ourselves there, but there are opportunities.

Michael Polark: Thank you.

Operator: Thank you. There are no additional questions waiting at this time. So I’d like to pass the conference back over to the management team for any closing remarks.

Quentin Blackford: Sure. Well, again, thank you for your time today. We’re incredibly pleased with the progress to date in the business and the strong operational performance that our teams have put together. We’ve never been more excited or believe stronger in the future that sits ahead of us. We’ll see many of you on the road over the course of the next quarter, and I look forward to sharing our next quarterly update in just a few short months. With that, take care.

Operator: This concludes today’s conference call. Thank you all for your participation. You may now disconnect your lines.