iRhythm Technologies - Q1 2023

Transcript

Operator (participant)

Hello, welcome to the iRhythm Technologies, Inc. Q1 2023 earnings conference call. My name is Lauren. I'll be coordinating your call today. If you would like to ask a question during the presentation, you may do so by pressing star followed by one on your telephone keypad. I will now hand you over to host Stephanie Zhadkevich, Director of Investor Relations, to begin. Stephanie, please go ahead.

Stephanie Zhadkevich (Director of Investor Relations)

Thank you all for participating in today's call. Earlier today, iRhythm released financial results for the first quarter ended 31st March 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 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 could 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 involve risks and uncertainties that could cause as-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 Securities and Exchange Commission. During the call, we will discuss certain financial measures that have not been prepared in accordance with US 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 this 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 their most directly comparable GAAP financial measures.

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, 4th May 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. With that, I'll turn the call over to Quentin Blackford, iRhythm's President and CEO.

Quentin Blackford (President and CEO)

Thank you, Stephanie. Good afternoon. Thank you all for joining us. Brice Bobzien, our Chief Financial Officer, and Daniel Wilson, our EVP of Corporate Development and Investor Relations, join me on today's call. My prepared remarks today cover progress we've made during the first quarter of 2023 and discuss the growth initiatives for our business. I'll turn the call over to Brice to provide a detailed review of our financial results and updated guidance. In the first quarter of 2023, we continued to build upon the solid momentum we had exiting last year, recognizing revenue of $111.4 million or 21% growth year-over-year.

Our commercial team did a terrific job building upon the discipline and rigor introduced in the back half of last year to capture key strategic wins driven by a continued push into primary care, as well as increasing penetration into large and national accounts. The outperformance in the quarter was driven by the strength of our Zio XT business, fueled by better-than-expected volume and another record quarter of new account openings. Additionally, we were pleased with the performance of a returned device rate for the quarter, as well as the performance of our Zio AT business, which grew 21% year-over-year on a revenue basis, both in line with our expectations. Encouragingly, growth during the first quarter came from across the business as we saw strong contributions from all regions, deeper penetration in our existing accounts, and a record number of both new accounts and new prescribers.

Volume from cardiologist prescribers grew nicely during the quarter, while contributions from primary care continued to outpace overall company growth. The interest in Zio from primary care physicians continues to grow, evidenced by the significant and growing interest from large national primary care networks. We continue to believe that the primary care channel will be a nice lever for growth as we are in the very early stages of a significant market expansion opportunity. Lastly, we saw continued growth from our large blue-chip accounts as our differentiated commercial strategies to drive further penetration into these valuable partners continues to deliver.

Our ability to deliver value across the continuum of care by quickly and accurately detecting arrhythmias for benefit of patients by enabling better clinical outcomes, and even more important in today's environment, by improving healthcare resource utilization, has resonated with our various stakeholders as we aim to deliver on our mission. Supporting this continued growth is a steady drumbeat of positive clinical data that continues to demonstrate Zio's value proposition and competitive differentiation in the marketplace. The CAMELOT data released at ACC in March was truly game-changing for patients, customers, and Zio XT in particular. This was the largest and most contemporary real-world comparative effectiveness analysis of ambulatory cardiac monitoring, retrospectively analyzing the ACM experience of nearly 290,000 diagnostic-naive patients.

Compared to all other ambulatory cardiac monitors, CAMELOT demonstrated that long-term continuous monitoring with Zio XT was associated with the highest diagnostic yield and the fastest time to clinical diagnosis, the lowest likelihood of retesting, and the lowest acute care healthcare resource utilization. With the data now in the hands of our commercial teams and the payer relations team, we are excited to further demonstrate how consequential it can be to choose the right monitoring service the first time.

As one example of the impact we are starting to see from CAMELOT, the Value Based Care Council or VBCC of the National Association of Managed Care Physicians or NAMCP has validated through an independent third-party review of evidence that Zio XT contributes value to health systems and payers. The NAMCP offers educational materials, evidence-based tools, and resources to help medical directors from purchasers, plans, and provider systems to make effective and informed decisions. The Value Based Care Council is composed of medical directors and chief medical officers from around the country who have experience and knowledge about value-based care, along with corporate members from the industry who share these interests.

In their final report after an objective review of Zio XT claims and evidence, they showed that the value proposition for Zio XT is credible and objective related to diagnostic yield, analyzable wear time, detection of many types of arrhythmias, lower likelihood of retesting compared with other monitoring types, improved clinical out times, and decreased time to diagnosis. Additional details and full results of this important collaboration will be announced at a later date. We believe CAMELOT data demonstrates that Zio XT should be the gold standard for long-term continuous monitoring. We also believe that the commercial release of our Zio monitor represents an improvement to the already high bar we've set for ourselves. In addition to its inconspicuous profile, the pliability of the new Zio monitor allows for comfortable wear and is designed to improve patient compliance and satisfaction.

Initial real-world and clinical experience data with Zio monitor also presented at ACC demonstrated high patient compliance with the potential to extend wear times in the future. 14-day data from 673 patients wearing Zio monitors demonstrated higher compliance and higher quality ECG compared to Zio XT, while 30-day extended wear monitoring yielded additional clinical findings beyond 14 days. Post-clearance evaluations of Zio monitor show consistent and even improved performance compared to Zio XT, with potential to greatly improving monitoring and decision-making for more complex patients. We continue to expect the full launch of Zio monitor later this year with the new platform providing significant product optionality into the future. We continue to drive towards realization of opportunities for future growth, we are just as committed to driving growth in a scalable, sustainable manner.

As mentioned on our last earnings call, we established a global business services center, and we are working toward ongoing business transformation activities to position the company to maintain patient satisfaction, scale globally, and perform more efficiently. We have hired a dedicated GBS leader along with a team that is now in place and anticipate opening our Manila office during the second quarter. During the first quarter, we also announced internal restructuring to better align the organization to pursue our strategic objectives and to drive operational efficiency, alignment, and focus. This allows us to increase the pace of organizational execution by realigning many functions in the business to create synergy, enabling our groups to work more efficiently and to scale more quickly. We look forward to how this will continue to elevate our ability to serve millions more patients as we continue our rapid growth.

Furthermore, our commitment to operating as responsible corporate stewards was highlighted in a recently refreshed ESG report released in April. This report and the excellent work by so many around the company that it represents reflects the elevated focus our organization has on ESG matters and reconfirms our commitment to growing responsibly and sustainably for the benefit of patients, customers, communities, employees, and the environment. Our company profile and the nature of our products dovetails nicely with ESG initiatives, be it the reusable, recyclable profile of our Zio device, our continued emphasis on equitable access to care, or our unwavering commitment to patients in the communities which we serve. This report is also a nice example of the governance mechanisms we've put in place over the past year to embed ESG policies and initiatives into our operations as we continue to transform the company.

We look forward to communicating progress against our roadmap in the future as a continued driver of long-term value creation for our stakeholders. Before turning to Brice, there's one final item on which I'd like to comment. As we will disclose in our 10-Q file today, after the quarter close on 4 April, we received an inquiry from the Civil Division of the U.S. Department of Justice seeking information and documents regarding the company's products and services. Our teams are working on responding to the DOJ's inquiry, and we will fully cooperate with the department's request. At this point, we are very early in this process of engaging with them, and it's too early to speculate on the precise motivations behind their inquiry or any anticipated duration of the engagement. As we have more information, we will be sure to provide the necessary updates.

In closing, we remain bullish on the business for 2023 and beyond. Continuing on the solid momentum of late 2022, we have begun the new year in a very strong position to drive continued growth in our core business and making the investments necessary to transform the company. We believe that we are well-positioned to capture the opportunities ahead while efficiently scaling our operations and have never been more excited by the future that we see in front of us. With that, I will now turn the call over to Brice to discuss our financial performance.

Brice Bobzien (CFO)

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 Quentin mentioned, first quarter results demonstrated continued momentum as we realized revenue of $111.4 million, representing 21% year-over-year growth. This strength was driven by significant volume growth in our core U.S. business, slightly offset by a low single-digit pricing decline in line with expectations. With national CMS rates in place as of 1st January 2023, we began leveraging our San Francisco IDTF with approximately 25% of Zio XT volume processed through the San Francisco location, also consistent with expectations.

Looking at new store, same store mix, new store defined as accounts that have been open for less than 12 months accounted for almost 35% of our year-over-year growth. While we continue to drive record new account openings contributing significant growth, this new store same store contribution mix is also reflective of tremendous volume growth from existing accounts, implying reduced account churn and increasing penetration in these accounts. Home enrollment for Zio Services was about 20% of volume in the first quarter. Moving down the rest of the P&L, gross margin for the first quarter was 67.9%, representing a 200 basis point decline compared to fourth quarter 2022. This decline was primarily driven by expected ASP fluctuations sequentially as we began processing claims for the CMS business at updated national rates beginning 1st January, as well as expected slight declines in our commercial realized ASP.

Gross margin in the first quarter 2023 represented 100 basis point improvement from first quarter 2022. This was driven by a reduction in unit cost to serve as we ramped volume significantly and were able to leverage our fixed cost infrastructure offset by year-over-year pricing headwinds. Note that cost of revenue during the first quarter 2023 included some duplicative costs as we began to leverage third-party providers for certain clinical operations and customer care services to enable growth and scale our operations. First quarter adjusted operating expenses were $109.5 million, up 13% sequentially and 31% year-over-year. The spend in the first quarter was generally in line with expectations, with the increase primarily driven by increased personnel expenses to support volume growth and elevated commissions for volume outperformance in our core business.

There were also some duplicative costs incurred in our operating expenses during the first quarter as we stand up our global business services center in the Philippines. Importantly, we also made incremental investments in R&D as we finalized development of our Zio monitor to prepare for commercial launch later this year, continued developing our Zio MCT product that we plan to submit for regulatory approval in the third quarter, and advanced initiatives in adjacent market opportunities. Adjusted net loss for the first quarter was $33.4 million, or a loss of $1.10 per share, compared to adjusted net loss of $17.9 million, or a loss of $0.59 per share in the fourth quarter of 2022. This compares to adjusted net loss of $0.80 per share, or a $0.30 decline versus first quarter 2022.

We reported approximately $5.7 million of expenses related to business transformation activities in the first quarter 2023. Also recall that in the first quarter of 2022, we incurred $26.9 million in impairment, restructuring, and transformation charges, primarily associated with the reduction in size of our San Francisco facility. Adjusted EBITDA in the first quarter 2023 was negative $12 million, reflecting a decline of $13.1 million sequentially and a decline of $7.2 million year-over-year. While this represented reductions compared to the fourth quarter 2022 and the first quarter 2022, this short-term decrease in adjusted EBITDA margin resulted from investments being made to our near-term volume growth drivers as well as long-term initiatives.

Turning to guidance, we are updating our outlook to reflect anticipated full-year revenue growth of approximately 17%-19% compared to 2022, representing a range of approximately $480 million-$490 million, contemplating our outperformance in the first quarter of 2023. Our outlook on anticipated pricing remains unchanged compared to prior expectations. We expect seasonality in line with non-pandemic historic trends with approximately 25% of full-year revenue anticipated in the second quarter of 2023. We continue to believe that gross margin will range between approximately 69% and 70% for the full year. Incremental gross margin improvements will be realized through volume growth contributions to our per unit cost as well as improvements to our fixed cost structure.

Recall that our full-year guidance contemplates a bit of pressure to gross margin in the middle of 2023 as we ramp to launch our Zio monitor service into the U.S. commercial marketplace. This will include an evaluation of our current Zio XT inventory levels and may reflect underutilized costs for our Zio monitor system as we scale the new product. We now anticipate that adjusted operating expenses in 2023 will range between approximately $417 million and $427 million, including updated variable compensation reflected as a result of increased volume demand. This quarter included some seasonal items that will not repeat for the remainder of the year, such as the return of our in-person global sales and leadership meetings for the first time in the last several years.

Additionally, as we stand up our global business services center in the Philippines and begin to leverage third parties, duplicative costs incurred in the first quarter will begin to step down over the remainder of the year. As a result, we anticipate that overall operating expense levels on a quarterly basis will step down slightly compared to the first quarter for the remainder of the year. Thus, we continue to believe that adjusted EBITDA margin in 2023 will range between approximately -0.5% and 0.5% of revenue. As a reminder, adjusted EBITDA will continue to exclude restructuring costs, transformation costs, and stock-based compensation expense. In 2023, we continue to anticipate incurring approximately $15 million-$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. Note that adjusted operating expense and adjusted EBITDA guidance do not include costs related to the Department of Justice inquiry as we are very early in the process of engaging with the department. We ended the first quarter in a strong financial position with $176.3 million of cash on hand to drive continued growth in our core business, invest in innovation, and lay the foundation for future expansion. While we continuously review our capital structure to support the best interests of the company and our stakeholders, we are confident in our liquidity position to operate our business for the foreseeable future.

We could not be more excited for the strong momentum in the business to continue, look forward to upcoming catalysts that we anticipate can drive growth in 2023 and beyond. With that, Quentin, Dan, and I would like to now open the call for questions. Operator?

Operator (participant)

Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure that your phone is unmuted locally. We also ask that you limit yourself to one question and one follow-up question. Our first question comes from Allen Gong from JPMorgan. Allen, please go ahead.

Allen Gong (Vice President and Equity Research Analyst)

Hi. Thanks. Congrats on the good quarter. I just had one quick one on the quarter and then a follow-up. Definitely encouraging to see the quarter starting off on a bit of a strong note with AT growing at 21%. When I think about you had talked about how it seems like AT is improving, device return rates are improving. How is that really tracking relative to expectations so far in the second quarter, and what more do you need to see before we can maybe see guidance moving up? You know, not to beat a dead horse, but up towards that 20% LRP.

Quentin Blackford (President and CEO)

Yeah. Hey, Allen, thanks for the question. You know, I've been very pleased with what I've seen in the business thus far with return device rates in the AT business. I would say that more or less we've been right in line with our expectations, if not slightly ahead of where we expected to be, but not materially. You look at the first quarter, the driver of the business is just the underlying volume strength that we're seeing. Our registrations in the quarter were up in the mid to high twenties as we start to approach 30%. Some of the strongest registration growth we've seen in almost two years now, and that's getting back into some COVID comparisons that start to get a little bit unique, right?

The registration growth has been phenomenal, and that's really what's driving the overall growth in the business. I still continue to believe that as we make progress with return device rates and AT returns to historic growth rates, that has the opportunity to provide some upside to the guidance that we've laid out today. But really the strength of the quarter was driven on the registration growth in the business.

Allen Gong (Vice President and Equity Research Analyst)

Got it. You know, for a less fun question, this Department of Justice inquiry is news to us.I believe you said it was civil, so hopefully downside is kind of limited. When I think about, do you have any sense of what they're actually looking into, the kind of timelines that you should expect for any updates on the process, and just kind of, what the downside could be to the inquiry? Thank you.

Quentin Blackford (President and CEO)

I think, it's a bit early at this point, Allen Gong, to really articulate anything more clear around the matter itself. We certainly will engage with the DOJ and try to learn as much as we can, and we'll communicate as we have more clarity around what that looks like. I think at the end of the day, we know that within this industry, these things occur from time to time. We understand that. I will tell you, we've done an incredible amount of work over the course of the last 12-18 months, with the new leadership team in place, building out incremental, more robust capabilities. We've put in place a chief risk function, a chief risk officer. We have a dedicated compliance function.

I mean, we've continued to mature the organization over the last year or so. That continues to give me confidence that, quality, compliance, all of these things are very important to us and will continue to be, and we're elevating our capabilities in the organization. To give you any specifics on what they might be focused on or where their focus is at, it's just too early at this point, and there's not a whole lot more we can comment on at this point in time. You know, as we do get more information, we'll certainly be sharing it.

Operator (participant)

Thank you. Our next question comes from Margaret Kaczor from William Blair. Margaret, please go ahead.

Macauley Kilbane (Equity Research Associate)

Hi, everyone. This is Macaulay on for Margaret. Thanks for taking our question, and congrats on the quarter. Obviously, the PCP momentum has continued, and from our channel checks, what we've heard is there's been better access to iRhythm compared to before. Are there certain partnerships where that is happening more than others? Just as a follow-up, is there a certain type of patient you're seeing now more than previous before you kind of had these partnerships?

Quentin Blackford (President and CEO)

Yeah, no, thanks for the question. I'll tell you on the access side, we spent a lot of time over the course of 2022 really working to ensure that patients that needed access to our product could get it. Nearly 93% of all patients from a commercial perspective have access into our product, the majority of which, the vast majority of which without any prior authorization for Zio XT. I think we've done a terrific job increasing access, creating awareness around it.

You know, one of the things that we're seeing in the marketplace. The product is so easy to use and apply that in many times, cardiologists are actually recommending that the primary care physicians, particularly within their own network, begin to prescribe the product and have the product applied much further upstream because it helps them really identify which patients they then need to see further downstream and spend time with. I think you've got the cardiologists who are making the push for this device to be utilized in more of the primary care setting. We're going directly at the primary care networks. We announced the agreement, last quarter with One Medical.

We continue to expand those with additional primary care networks that only increase the utilization of the product in that primary care space and certainly elevate the awareness of the value of the product. I think it's a combination of things, both access that we're working to create and doing a nice job improving, but also just creating a lot of awareness in the primary care channel with respect to how easy this product is to use and how it can help them streamline the patients they're caring for and where they need to go next within their network.

Macauley Kilbane (Equity Research Associate)

That's great. Just one real quick on Zio monitor. In terms of what's being assumed in the mix between Monitor and Zio XT once it does enter the full launch.

Quentin Blackford (President and CEO)

Yeah, it's a good question. Thanks for asking. I would say from a guidance perspective, we're not necessarily anticipating an acceleration in volume or anything specifically related to Zio monitor. What I would say is we absolutely believe this is a great product, and there's absolute opportunity for upside with it. From a guidance perspective, not necessarily anything baked in specific to Monitor.

Macauley Kilbane (Equity Research Associate)

Great. Thanks again for taking the questions.

Quentin Blackford (President and CEO)

Thank you.

Operator (participant)

Thank you. Our next question comes from Marie Thibault with BTIG. Marie, please go ahead.

Marie Thibault (Managing Director and Medical Technology and Digital Health Analyst)

Hi. Congrats on a great quarter, and thanks for taking the questions. Wanted to ask my first here on the Novitas final LCD that was out. We certainly get some questions on it, just wanted to hear your latest thoughts on the risk around that LCD, the possibility of spread to, you know, a Noridian or a different geography, any details you can offer on, you know, the number of prescriptions, you know, that would meet the EKG requirement. Any details around that?

Quentin Blackford (President and CEO)

Hey, Marie. Thanks for the question. Yeah, look, I don't view the final LCD out of Novitas as anything that gives me any concern really at all. I don't think it's significantly restrictive. I think it mirrors, quite frankly, many of the commercial policies that are already out there that we navigate in and around every single day. I mean, at the end of the day, you look at where they landed with the final position of their LCD, and the reality is there's a handful. You can probably count 10-12 different sort of criteria that so long as the patient is meeting or the physician believes it is taking place, enables or allows them to prescribe a path technology.

You know, I think the initial concern was, is there gonna be a requirement for a 12-lead ECG to be performed before they can step into something else? That's not the case at all. That's one of the 12 criteria, but they're all sort of ors, if you will. Meaning if you meet any one of those significant list of criteria. I don't view this as anything that's gonna impact sort of the momentum in the marketplace. Again, it's very much in line with what we see with the majority of our commercial payers. If you get into the details, even on the 12-lead ECG, for example, you just start to do some market checks, you're gonna find that north of 80%, upwards of even 90% of physicians are already capturing this sort of information.

We're providing it, like I said, in the commercial payer universe already. I don't have any concerns around it. Certainly we're mindful of it, but it's a normal part of how we operate the business today and how the physicians, I believe, interact with their patients today. No real concern from our perspective there.

Marie Thibault (Managing Director and Medical Technology and Digital Health Analyst)

Okay, good to hear. Good to hear you confirm that. I'll ask my follow-up here on the San Francisco facility. Sounds like about 25% of the volume is being processed through that facility. What are you expecting, in the numbers you'd given us for Q2 on guidance in terms of the shift toward that? How is hiring and sort of all the hurdles you need to jump to shift more volume going on that side? Thanks for taking the questions.

Quentin Blackford (President and CEO)

Sure. Hey, Marie, it's Brice. Yeah, we still anticipate about 50% of the full year volume running through the San Francisco IDTF. No differential from what we anticipated from the beginning of the year. As you can imagine, that would imply a ramp throughout the year. As it stands now, hiring is going well. It's still something we monitor on a regular basis, but no deviation from the contemplation in the original guide.

Marie Thibault (Managing Director and Medical Technology and Digital Health Analyst)

Very good. Thank you.

Quentin Blackford (President and CEO)

Yep.

Operator (participant)

Thank you. Our next question comes from Nathan Treybeck from Wells Fargo. Nathan, please go ahead.

Nathan Treybeck (Equity Research VP)

Hi. Thanks for taking the questions. Can you talk about the ASP declines you saw as you began processing at the new national rate? How should we think about this as you shift your volumes to the San Francisco IDTF? Thanks.

Quentin Blackford (President and CEO)

Sure. Hey, Nathan, this is Brice. Yeah. In the first quarter, if you remember looking back into 2022, from a CMS perspective, we were still navigating most of the volumes through the Houston IDTF. At that point, it was at a lower ASP point than what we ultimately ended up pushing through Chicago. In the specific to XT, I would say there's actually a bit of pricing tailwind from a CMS perspective on the XT side. Now, I will say on the AT side, it's almost exactly the other way, and they effectively net each other off. There's a bit of overall pricing pressure. On the AT side, the national rate was established and call it 11% less than what we saw in 2022.

All volumes on the AT side go through San Francisco, both in 2022 as well as 2023. That 11% impact is basically the way you can think about AT. On the commercial side, that low single digits played through. A portion of that was those commercial contracts that are tied to the CMS rate. The other portion of that would just be normal course of business and contracting. Effectively, it came in right in line with expectations as we think about Q1, and again, that's the reason we reiterated the ASP guide for 2023.

Nathan Treybeck (Equity Research VP)

Great. Thanks. In terms of the Zio monitor, over what time frame should we think about you kind of moving all your volumes, your XT volumes to the monitor? As that happens, how should we think about margins? Thanks.

Quentin Blackford (President and CEO)

Yeah. I think from a commercial perspective, you're gonna see that migration taking place over the course of 2024. Obviously, I think as quickly as we can move towards the monitor, we're gonna wanna do that. At the same time, we're ramping production volumes, we're introducing some automation on the Zio monitor so that we can produce that at a lower cost in time and at scale. All of those are gonna play into sort of how quickly we can work through that conversion, the hope is to get to monitor as quickly as we possibly can.

I think in terms of the gross margin progression, Brice, certainly feel free to speak to that, but we know that we're gonna have a bit of pressure in the third quarter, late third quarter, sort of as we think about transitioning into the release of monitor, and it's not at full scale, so it's gonna put a bit of pressure on the gross margin. We also got to think about how we step out of the Zio XT product, and do we have any inventory charges that we have to look at from a reserves, excess, obsolescence. We'll pay attention to those sort of things, all of which is contemplated in our forward-looking guidance.

Once we get into monitor and start to really build that and ramp it and work into the efficiencies of that automation, I think you're gonna see some benefits in that gross margin line. We'll give more color and clarity around that when we're ready to set expectations for 2024, but we certainly see Zio monitor as something that can drive some nice gross margin improvement for us into the future.

Nathan Treybeck (Equity Research VP)

Great. Thanks.

Operator (participant)

Thank you. Our next question comes from Cecilia Furlong from Morgan Stanley. Cecilia, please go ahead.

Cecilia Furlong (Equity Research Analyst)

Great. good afternoon, and thank you for taking the questions. I wanted to ask about AT, just following some of the recent disruption. It did look like strength in the quarter, but as you think going forward, are you back to what feels like a normalized growth rate for AT? How are you factoring that into your guidance, relative growth versus XT? Wanted to ask too, just tied in with that for Zio MCT coming out, in the future, how you're thinking about timeframe for that, if it's 30 days shorter, just would love your outlook at this point.

Quentin Blackford (President and CEO)

Sure. I think from an AT perspective, Cecilia, Brice sort of mentioned this in some of his comments earlier in response to one of the questions. You know, we saw, I would say low teens in terms of pricing pressure coming out of the AT business. You had the CMS rate that was down about 11% with respect to AT, and on the commercial side, a couple points of incremental pressure there. Think about it as the low teens in terms of pricing pressure, and we communicated that the AT business grew around 21%. From a volume perspective, AT was up in the mid-30s. That's down from where it was at last year, which was closer to the upper 40s.

We're not back to those historic growth rates, but yet it is growing in line with sort of how we expected it would in the guidance that we set. To the degree that we can get that back up into those historic growth rates, then there's upside to the financial forecast that we put out there. That's not something that we necessarily wanna get ahead of ourselves with. We wanna see that show up in the results, and then we can reflect it more aggressively in the, in the financial guidance that we put out there. I will say we've been pleased with the progress. With respect to Zio MCT we hope to get on file with the FDA here in the mid part of the year. Everything's tracking very well to that.

Really pleased with the progress the teams have made to get on file from an FDA perspective. We would look to have approval sometime out in 2024 and then potentially have that product into the market in the back part of 2024. The idea would be certainly to have an extended wear period beyond the 14 days that our Zio AT has today. Not sure we get all the way to the 30 days, but we're gonna be a whole lot closer to it, and I think start to really eliminate this argument from a competitive perspective that, 14 days may not be enough for what they're looking for. While we don't get all the way to 30 days, it's close enough in that it starts to eliminate that issue for us altogether.

I'm excited by what we're gonna see with Zio MCT. I think it's a terrific product. I would say we're not waiting for MCT to continue to work on closing the gaps in our AT portfolio. We'll introduce the AF burden onto our Zio AT product here in the next 30 to 45 days or so into the U.S. marketplace, which continues to enhance the value of proposition of that particular product for us. There are reasons we can get back to those historic growth rates this year, but we wanna see that play out before we start to really reflect it in our guidance more aggressively.

Cecilia Furlong (Equity Research Analyst)

Great. Appreciate the color. Just turning again to PCPs and the strength that you've seen there. I don't know if there are any metrics you can put around it, but just how you're looking at 2023 contributions going through that channel versus what we saw in 2022 and from a top-line standpoint, really how you're thinking about that reflected in your overall guidance range? Thank you for taking the questions.

Quentin Blackford (President and CEO)

I will tell you, I think a lot of the volume strength that we saw in the first quarter, again, a record for us in nearly two years now, is being fueled by the strength of the primary care adoption of the technology. It's interesting in terms of how it's showing up. I think you see a little bit of this in the statistic that Brice pointed out in terms of 35% of our growth is coming from new accounts and call it 65% coming from existing accounts. What you're seeing is in those existing accounts, a lot of further penetration into the account itself and starting to work with the primary care physician within the account versus just the cardiologist.

It's driving a lot of the growth in our existing accounts as well as we move into other channels of the account we're already in. I think it's a bit too early to give specific measures around the progress with respect to PCP. I think that's something we'll continue to think about into the future. Right now, I would tell you the majority of the outperformance is really coming from these incremental channels that we're starting to really position the product for, but also utilizing the voice of the cardiologist, just in terms of how easy the product is to move it further upstream and get into these other channels. It's quite encouraging in what we're seeing.

As I shared, the strength of the quarter was on the back of the true underlying volume in the period itself. We wanna see that continue to play out before we update any financial guidance. Very encouraged by what we're seeing there.

Cecilia Furlong (Equity Research Analyst)

Great. Thank you.

Operator (participant)

Thank you. Our next question comes from Richard Newitter from Truist. Richard, please go ahead.

Richard Newitter (Managing Director and Senior Research Analyst)

Hi. Thanks for taking the questions. Quentin, I was hoping or wondering, could you comment a little bit on the month-to-month trends through the quarter, particularly as you exited in March and kinda, what you saw in April?

Quentin Blackford (President and CEO)

You know, it's a good question, Rich. I will tell you in the first quarter, January and February were incredibly strong months for us. We did see March pull back a bit. We saw that remain sort of at that lower level through the early part of April, but it came back very strong in the back part of April and has been very strong here in the very early part of May as well. I attribute that, and this is something we pay very close attention to and I think have a good finger on the pulse. I do think sort of the holiday period, the spring break period through that late March, early April timeframe did feel like it was a bit heavier than what we've seen historically.

I think through some other channel checks that's been validated. What we've seen in late April and into the early part of May has been really, really encouraging and something that we're very excited to be seeing. I think it comes back to why we just don't wanna get ahead of ourselves at this point in time. You know, the most recent trends in the business are something we're very pleased with.

Richard Newitter (Managing Director and Senior Research Analyst)

Okay. That's, that's really helpful color. Maybe just a follow-up here. You know, thinking about the guidance move 16-18 to 17%-19% now year-over-year, you just did 21%. I guess, A, is any color you can give on the quarterly cadence between 2Q and 4Q, anything you'd wanna call out here? Do you feel comfortable more or less where consensus is for 2Q? B, Quentin, why wouldn't you hit the 20% marker, or stay in the 20% arena for longer? I guess, what's the reason why growth would decelerate? Thanks.

Quentin Blackford (President and CEO)

Yeah. Rich, I think it's a fair question. I think, there's certainly the potential there to be at 20%, you know, I kinda look at it as we're a quarter into the year. We certainly aren't gonna get out ahead of ourselves. We're incredibly bullish on what we're seeing in the business, I think there's a lot of economic uncertainty that continues to remain out there. We wanna be mindful of that. You know, when we put something out there and tell you that we're gonna deliver on it, we wanna deliver on it. I think we just need a little bit more time to get comfortable to raise it, up into that 20% range.

Certainly, you look at the first quarter, return to device rates were not all the way back to where they were in the prior year. Zio AT is not all the way back to where it was. Yet volume was incredibly strong, and we grew north of 20%, nearly 21%. We know that we can grow more than 20%, but we wanna see this continue to play out for a little bit of time before we get ahead of ourselves. In terms of the quarterly cadence, I look at Q2, I'll give you a bit of color around it. You know, historically, we're gonna drop 24.5%-25% of revenue into the second quarter. I think that's the right way to continue to think about it.

Sequentially, it's probably gonna step up, right around that 8% range or so is kinda how we've modeled it, and I think that's the way you ought to think about it for the time being. If you're, if you're around those ranges, then I think we're all probably thinking about the second quarter in the similar way. Then look, we'll see how volumes play out and, we'll deal with the back half of the year as we have more confidence in what the volumes might look like. Right now, we feel very good with that back end guidance that we put out there.

Richard Newitter (Managing Director and Senior Research Analyst)

Thank you, congrats on the quarter.

Quentin Blackford (President and CEO)

Thanks, Rich.

Operator (participant)

Thank you. Our next question comes from Bill Plovanic from Canaccord. Bill, please go ahead.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

Great. Thanks. Good evening, and thanks for taking my questions. I'm a little different. I'm just curious, you know, Medicaid, you know, is a state by state, and that's something I think, you know, before the Category I code, you didn't get paid on a lot, and there are a lot of states you didn't even go after. I'm just curious if you could help us understand kinda what have you seen since the implementation of the Category I code? How should we think about the potential opportunity that you could pick up from this over the next and the timeframe in which you could capture this?

Quentin Blackford (President and CEO)

Hey, Bill. It's Greg. good question. Medicaid is one that we're actually really coming onto our radar, and frankly, we've internally set up a committee that's focused on just this. You know, we're really taking a state by state approach in certain situations where we see the highest portion of our patient population ultimately coming through those channels. That's honestly what you have to do. You have to have a code in place, not only with the Cat code for broader coverage from, basically the category being in place on the Medicare side, but also have that code in place with the individual states. From a Medicaid perspective, honestly, we're going down the line and saying which ones do we work on first.

Some are a little bit easier to get after than others, but we have a process where we're working into each. Now, I will tell you, for the most part, we're still covering those patient populations. What's happening is effectively, it's going without payment. What you'll see as we make progress is that non-contracted bucket that we report in our 10-Q will continue to shrink, and ultimately it will shift up and you'll start to see the ASP benefits associated with it. I think for us, I would say it's absolutely something we're thinking about, and we're making it a priority and we're pushing it forward.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

Then, if you had to quantify that, how much of an opportunity is that is dollar-wise? If, if today, if all of that, Medicaid that you're not getting paid for, you did get paid for it some reasonable reimbursement rate.

Quentin Blackford (President and CEO)

Yeah. Maybe I best quantify it on a unit basis where I would say, effectively now maybe we're getting $25-$30 per unit. I can see a path. It's usually a percentage of the Medicare established rate, call it 70%, depending on the state. Think about that as going from, that $30 point price point up to $170. We haven't necessarily put volume out there as to what the percentage is of that non-contract is, but it's pretty substantial on a per unit basis. Again, not all states will happen at once, but it becomes a reasonable opportunity for us.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

Okay. If I could just ask on international, just any update on Japan, designation reimbursement?

Quentin Blackford (President and CEO)

Yeah. Thanks, Bill. You know, certainly excited by Japan. I think we're gonna hear very shortly sort of the high medical needs designation, whether we're gonna receive that or not. I expect it sometime within the next 30 days. Once we have that, our file is ready to be submitted from a regulatory perspective and will be on file immediately. I think we'll be filing anytime here in the next, call it 30-60 days there in Japan and hope to have an approval sometime in the course of 2024, and then moving on to getting it into the product or, sorry, getting the product into the market. We're very close.

I think this, it's probably quite honestly been a month or two beyond where we were hoping to be. The high medical needs is something that's worth pursuing and we're gonna get an answer to it soon.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

Thank you. Thanks for taking my questions.

Operator (participant)

Thank you. Our final question comes from Suraj Kalia from Oppenheimer. Suraj, please go ahead.

Suraj Kalia (Managing Director and Senior Analyst)

Quentin, can you hear me all right?

Quentin Blackford (President and CEO)

We got you.

Suraj Kalia (Managing Director and Senior Analyst)

Sorry, but I'm in a train, so pardon the background noise. Quentin, I'll ask two questions, both of them together. The Zio monitor and its introduction for, let's say, the Zio XT, 30-day. Should we think about a staged approach, first 21 days and then 30 days? What's the status of the gateway for 21-day battery? My second question, Quentin, where are you on the discussions with the payers for offshoring, the report readout and analysis? You'll set up a facility in Manila. Curious how payers are responding to that. Thank you for taking my questions.

Quentin Blackford (President and CEO)

Sure. Thanks, Suraj. Appreciate the question. Look, Zio monitor, just to be clear, the initial launch of Zio monitor will replace Zio XT, which is a 14-day product, and the initial Zio monitor will be put into the market as a 14-day product. That platform, the very same form factor is what will be used for our Zio MCT product when we launch that. You know, that's gonna be anywhere from 21-30 days in terms of its wear period. We continue to work through that with respect to Zio MCT, but that'll be the longer duration wear period.

I think what you're referring to is we had put out a study, there was some trial data that was published back at ACC that just demonstrated the Zio monitoring, which again is the same form factor as what Zio MCT will be, has very successful wear properties with it all the way out to 30 days. We'll keep Zio Monitor in terms of what's gonna replace Zio XT at the 14-day period for the time being, but I think it creates some flexibility if we wanted to think about that over a longer duration. With respect to the gateway, the gateway is something that we're working with also to extend sort of the duration of its usability, if you will. Today it's 14.

Well, it's 14 days with Zio AT, with Zio MCT, I think we can get that out to 21+ days. I think if we start to look at that in a little bit of a different way to maybe where we make it rechargeable, of course it can go as long as it needs to go, depending on how many days we have the Zio MCT patch working, which, could be up to 30 days potentially. It gives us a lot of flexibility from that perspective. On the payer side with respect to some of the offshoring or setting up the Manila facility, I would tell you we're making very good progress.

I would say some of the largest payers we've already worked through and have the consent to be able to process their claims offshore. Anything with the U.S. government, we're keeping all onshore, and we're very careful about that from a compliance perspective and have the proper controls in place to make sure that we're monitoring that really on a case-by-case basis. I've been pleased with the progress with the payers, and we started with the largest payers, and now we're continuing to work down the list to some smaller payers. I think, to be completely transparent with you, there are some payers who prefer not to leverage the offshore capabilities. We respect that, and we can certainly accommodate that in our workflow and make sure that's the case.

The big payers are pretty well understanding of it. Frankly, in many cases, many of these big payers have offshoring capabilities of their very own, set up, in the same city centers that we're looking at setting up operations with. We feel good about that in that we've made a lot of good progress around that effort.

Operator (participant)

Thank you. We have no further questions. I'll now hand back over to the management team for closing remarks.

Quentin Blackford (President and CEO)

Terrific. Well, thank you. I will say we're extremely encouraged by the start of the year and the momentum that we see building within our business as we focus on driving towards our strategic objectives. I wanna take the opportunity to thank all of our teams for their hard work, their dedication to really advancing our cause as we aim to serve all patients who can benefit from our products and services. That list continues to grow each and every day. Thank you for joining our call, and we look forward to catching up the next time.

Operator (participant)

This concludes today's call. Thank you for joining. You may now disconnect your lines.