Q2 2025 iRhythm Technologies Inc Earnings Call

Bethany: Good afternoon. Thank you for attending today's Irhythm Technologies, Inc. Q2 2025 earnings conference call. My name is Bethany, and I will be the moderator for today's call. All lines will be muted during the presentation portion of the call, and we do ask that you limit yourself to one question. I would now like to pass the conference over to our host, Stephanie Zhadkevich, Senior Director of Investor Relations. Please go ahead.

Good afternoon.

Thank you for attending today. I Rhythm Technologies Inc, Q2 2025 earnings conference. Call, my name is Bethany and I will be the moderator for today's call all lines. Will be muted during the presentation portion of the call. And we do ask that you limit yourself to 1 question. I would now like to pass the conference over to our host Stephanie

B****, Senior Director of Investor Relations. 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, 2025. 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 involve 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.

Thank you all for participating in today's call. Earlier today, we released financial results for the second quarter and for the period ending June 30, 2025.

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 involve risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

Stephanie Zhadkevich: 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 this 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 on our earnings release in 10-Q for reconciliation of these measures to the most directly comparable GAAP financial measures.

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 10K and form, 10 Q, respectively filed, with the Securities and Exchange Commission.

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.

Stephanie Zhadkevich: Unless otherwise indicated, all references to financial measures in this call, other than revenue, refer to non-GAAP results. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, July 31, 2025. 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.

The presentation of this additional information should not be considered in isolation, or as a substitute for, or superior to results prepared in accordance with GAAP. Please refer to the tables in our earnings release in the 10-Q for reconciliation of these measures to the most directly comparable GAAP financial measures, unless otherwise indicated. While references to financial measures in this call refer to revenue, we are discussing non-GAAP results. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, July 31, 2025. I reiterate that we disclaim any intention or obligations, except as required by law, to update or revise any financial projections or forward-looking statements because of new information, future events, or otherwise.

Quentin Blackford: Thank you, Stephanie. Good afternoon, everyone, and thank you for joining us today. Dan Wilson, our Chief Financial Officer, is with me on today's call. My remarks will cover our business performance during the second quarter of 2025 and our outlook for the remainder of the year. I will then turn the call over to Dan to provide a detailed review of our financial results and updated guidance for 2025. We're excited to report strong second-quarter results with $186.7 million in revenue, representing more than 26% year-over-year growth driven by acceleration within our core long-term continuous monitoring business, continued progress with innovative channel partners, and sustained strength in our ZOAT product line.

And with that, I'll turn the call over to Quinton Blackford, our rhythm is president and CEO.

Thank you, Stephanie. Good afternoon, everyone. And thank you for joining us today. Dan. Wilson our Chief Financial Officer is with me on today's call, my remarks will cover our business performance. During the second quarter of 2025 and our outlook, for the remainder of the year, I will then turn the call over to Dan to provide a detailed review of our financial results and updated. Guidance for 2025.

Quentin Blackford: We achieved record new account openings in long-term continuous monitoring driven by innovative channel partnerships in combination with continued strong growth from recently launched IDN customers that are adopting both ZO Monitor and ZOAT, leading to record revenue quarters for both product lines. We're also encouraged by the momentum we're seeing across our international markets, with continued strong demand in the United Kingdom, steady uptake in four additional European countries, and our broad commercial launch in Japan, all demonstrating the global potential of our platform and our expanding pillars of growth. As we've discussed for several quarters, Irhythm's strategic focus on moving prescribing early in the care journey to primary care physicians has not only resulted in greater capacity for cardiologists and electrophysiologists to see qualified patients, but has also enabled proactive monitoring to be offered upstream to pre-identified patients who may otherwise be asymptomatic.

We're excited to report. Strong second quarter results with 186.7 million in Revenue. Representing more than 26% year-over-year growth driven by acceleration within our core. Long-term continuous monitoring business continued progress with Innovative Channel partners and sustained strength in our zoat product line.

We achieved record new account openings and long-term continuous monitoring driven by innovative channel partnerships, combined with continued strong growth from recently launched ID and customers who are adopting both Zio Monitor and Zoat, leading to record revenue quarters for both product lines.

We're also encouraged by the momentum we're seeing across our international markets, with continued strong demand in the United Kingdom, steady uptake in four additional European countries, and our broad commercial launch in Japan. All demonstrating the global potential of our platform and our expanding pillars of growth.

Quentin Blackford: We've realized the benefits of this approach within our core business, where we continue to see strong accelerating volume growth driven by expanding prescribing patterns within additional channels of our large installed base, further enabled by our EHR integration strategy and the focused execution of our commercial team. Over the past year, they've deepened engagement across existing accounts and expanded our footprint within large health systems, many of which have quickly grown into some of our most significant relationships. These results highlight our differentiated ability to deliver scalable, system-wide solutions that resonate with health systems seeking streamlined, single-vendor approaches. Our Epic Aura solution, which we began offering more broadly earlier this year, is generating strong customer interest and demonstrating early operational impacts. Many early adopters are already expanding ZO usage to new departments and care settings, leading to both volume growth and improved patient access.

As we've discussed for several quarters, high rhythm strategic focus on moving prescribing early in the care journey to primary care physicians has not only resulted in greater capacity for cardiologists and electrophysiologists to see qualified patients, but has also enabled proactive monitoring to be offered upstream to pre-identified patients who may otherwise be asymptomatic. We realized the benefits of this approach within our core business, where we continue to see strong, accelerating volume growth driven by expanding prescribing patterns within additional channels of our large installed base, further enabled by our EHR integration strategy and the focused execution of our commercial team. Over the past year, they've deepened engagement across existing accounts and expanded our footprint within large health systems.

Systems, many of which have quickly grown into some of our most significant relationships. These results highlight our differentiated ability to deliver scalable systemwide solutions that resonate with health systems seeking streamlined, single-vendor approaches.

Quentin Blackford: These integrations are also delivering significant efficiency gains, reducing project implementation times by over 50% on average. With over 40 health systems now actively implementing or preparing Aura integrations, we're excited about the continued expansion of this offering. Building on this solid foundation in our core business, we're seeing accelerating growth from innovative national account openings as we work toward addressing approximately 27 million undiagnosed patients at risk for arrhythmias in the United States alone. This represents a significant market opportunity that we're uniquely positioned to capture. During the second quarter, the contribution from innovative channel partners continued to grow as we added more than 1,000 prescribers at Signify Health, launched with another nationwide partner in Centerwell, and renewed the program with the innovative channel partner from the fourth quarter of last year.

Our epic Aura solution, which we began offering more broadly earlier this year, is generating strong customer interest in demonstrating early operational impacts. Many early adopters are already expanding usage to new departments in care settings, leading to both volume growth and improved patient access. These integrations are also delivering significant efficiency gains, reducing project implementation times by over 50% on average. With over 40 health systems now actively implementing or preparing Aura integrations, we're excited about the continued expansion of this offering.

Quentin Blackford: What gives us confidence in this approach, albeit still in the very early stages of this market expansion, is that all of our innovative channel partners have increased their activity after pilot launches and are contributing in progressively meaningful ways as we continue adding additional partner accounts. We now have 12 partners under contract covering approximately 2 million potential patients with a robust near-term pipeline of 40 active discussions and a long-term target list of approximately 100 potential partners in the US market. We're optimistic this will be a meaningful contributor to our growth for years to come due to the expected repeat monitoring, new members entering the funnel, and impacting patient health statuses in the populations we serve.

Building on this solid foundation in our Core Business, we're seeing accelerating growth from the Innovative national account openings. As we work toward addressing approximately 27, million undiagnosed patients at risk for AIDS in the United States alone. This represents a significant Market opportunity that we're uniquely positioned to capture during the second quarter, the contribution, from Innovative Channel Partners, continue to grow, as we added more than 1,000 prescribers at signify, Health launched with another Nationwide partner in Center. Well, and renewed the program with the Innovative Channel partner from the fourth quarter of last year.

Quentin Blackford: An essential contributor to success in these programs has been a growing body of real-world evidence describing the importance of early arrhythmia detection, especially in adjacent disease states where patients may already have or be at risk of developing arrhythmias. At the American Diabetes Association event in June of this year, retrospective real-world analysis of patients with type 2 diabetes, some of whom also had chronic kidney disease, demonstrated that cardiac arrhythmias present frequently and early, often preceding major cardiovascular events such as heart attack, stroke, or heart failure. These results build upon findings presented at the American Heart Association in 2024, which demonstrated that patients with diabetes and COPD who developed arrhythmias had twice the hospitalization rate, 35 to 50% higher emergency care cost, and hospital stays up to five days longer compared to matched patients without arrhythmias, all of which drive up costs within the healthcare system.

What gives us confidence in this approach? Albeit still in the very early stages of this Market expansion. Is that all of our Innovative Channel Partners, have increased their activity after pilot launches and are contributing in progressively, meaningful ways. As we continue adding additional partner accounts. We now have 12 Partners under contract covering approximately 2 million potential patients with a robust near-term pipeline of 40 active discussions and a long-term Target list of approximately 100 potential Partners in the US market. We're optimistic, this will be a meaningful contributor to our growth for years to come due to the expected. Repeat, monitoring new members, entering the funnel and impacting patient Health, statuses in the populations, we serve

Quentin Blackford: Furthermore, real-world data presented at the American College of Cardiology event in May of this year demonstrated that fewer than one in five patients experienced a symptom coinciding with an arrhythmic episode, reinforcing the need to monitor patients based upon unique health factors instead of symptoms. ZO is ideally positioned to address this growing market need. As published in our Camelot data and reinforced in our Avalon data presentation at HRS this year, ZO long-term cardiac monitoring is associated with higher diagnostic yield, lower likelihood of repeat testing, and lower likelihood of cardiovascular events compared to other long-term cardiac monitoring products. These are very important, distinctive features of our ZO platform that allow us to find and enable the treatment of arrhythmias at lower cost.

At the American Diabetes Association event in June of this year, retrospective, real world, analysis of patients, with type 2 diabetes. Some of whom also had chronic kidney disease demonstrated. That cardiac arrhythmias present frequently and early often preceding major cardiovascular events such as heart attack stroke or heart failure. These results build upon findings presented at American Heart Association in 2024, which demonstrated that patients with diabetes and COPD who developed a rhythm, as had twice, the hospitalization rate 35 to 50% higher, emergency care costs in hospital. Stays up to 5 days longer compared to match patients without arrhythmias. All of which drive up costs within the Healthcare System. Furthermore, real world data presented at the American College of Cardiology events in May of this year demonstrated that fewer than 1 in 5 patients. Experienced a symptom coinciding with an arrhythmic episode reinforcing. The need to monitor patients based upon unique Health factors instead of symptoms zo is ideally positioned to address this growing Market need as published in our camp.

Quentin Blackford: To further enable this proactive monitoring strategy for more patients, we're particularly excited to highlight our recent partnership with Lucem Health, a leader in AI-driven early disease detection solutions. This partnership represents a significant step forward in our mission to accelerate early detection of undiagnosed arrhythmias and other associated comorbid conditions. As we announced earlier today, this partnership is a first-of-its-kind offering utilizing Lucem's predictive AI to help identify arrhythmias earlier in patient populations with an elevated risk for arrhythmias. Through this comprehensive solution, we're bringing together real-world claims data, EHR integration, and predictive AI to enable physicians to identify appropriate patients for proactive monitoring using ZO ECG monitoring services and deliver precision medicine solutions for population health management.

Camelot data and reinforcing our Avalon data presentation at HRS. This year, Zeo, long-term cardiac monitoring, is associated with higher diagnostic yield, lower likelihood of repeat testing, and lower likelihood of cardiovascular events compared to other long-term cardiac monitoring products. These are very important distinctive features of our Zeo platform that allow us to find and enable the treatment of arrhythmias at lower cost.

To further enable this proactive monitoring strategy. For more patients, we're particularly excited to highlight our recent partnership with lusome health, a leader in AI driven early disease detection Solutions. This partnership represents a significant step forward in our mission. To accelerate early detection of undiagnosed arrhythmias and other Associated comorbid conditions.

Quentin Blackford: This initiative positions us to empower organizations that shift from reactive care to proactive preventative care, delivering data-driven insights for review by physicians to support better outcomes and financial efficiency across populations. We believe this approach will support broader healthcare system goals to extend value beyond individual patient diagnosis to population health initiatives and value-based care strategies across specialties. By embracing proactive arrhythmia detection, leading to earlier care intervention, we can help patients and members live fuller, more meaningful lives grounded in wellness, not crisis, while at the same time reducing the cost burdens of our existing healthcare system. With ZOAT, we delivered another record quarter driven by sustained momentum across both new and existing accounts. Our commercial team has executed exceptionally well on two fronts.

As we announced earlier today, this partnership is a first of its kind offering utilizing glucans predictive AI to help identify arrhythmia as earlier in patient, populations with an elevated risk for ahmia. Through this comprehensive solution, we're bringing together. Real world claims data EHR integration and predictive AI to enable Physicians to identify appropriate patients for proactive. Monitoring using, Zoe CG monitoring services and deliver, Precision medicine solutions for population Health Management.

This initiative positions us to empower organizations that shift from reactive care to proactive, preventive care, delivering data-driven insights for review by physicians to support better outcomes and financial efficiency across populations. We believe this approach will support broader health care system goals to extend value beyond individual patient diagnosis and the population health initiatives and value-based care strategies across specialties.

By embracing proactive arrhythmia detection leading to earlier care intervention. We can help patients and members live, Fuller, more meaningful lives grounded in Wellness, not crisis while at the same time, reducing the cost burdens of our existing Health Care system.

Quentin Blackford: First, by expanding adoption of ZOAT within our longstanding customer base, more of which are now integrating both ZO Monitor and ZOAT into the workflows, and second, by bringing new accounts on board with full system integrations from the outset. This dual-pronged approach is enabling us to deliver more comprehensive solutions to health systems and is accelerating our growth in a market where we still hold low double-digit share compared to the more than 70% market share in our core long-term monitoring segment. The consistent growth over the past three quarters reinforces our confidence in the significant opportunity ahead. Our next-generation ZO MCT product, for which we expect to file the 510(k) this quarter, is designed to significantly enhance our competitive position in this large, underpenetrated market.

With UAT, we delivered another record quarter driven by sustained momentum across both new and existing accounts. Our commercial team has executed exceptionally well on two fronts. First, by expanding the adoption of Zoat within our long-standing customer base, more of which are now integrating both Zeal Monitor and Zoat into their workflows. Second, by bringing new accounts on board with full system integrations from the outset. This dual-pronged approach is enabling us to deliver more comprehensive solutions to health systems and is accelerating our growth in a market where we still hold a low double-digit share compared to the more than 70% market share in our core long-term monitoring segment.

The consistent growth over the past three quarters reinforces our confidence in the significant opportunity ahead.

Quentin Blackford: Key improvements we intend to submit to the FDA include moving ZO MCT onto the same form factor as ZO Monitor, with a smaller footprint, better adhesion, and extended battery life, extending wear time from 14 days to 21 days, and advanced software for enhanced detection parameters and an improved final wear report. While we're encouraged by the success of our ZOAT service, we believe that our next-generation MCT, or ZO MCT, could be even better for our customers and their patients. Additionally, our market access and payer relations teams have made significant progress, expanding access to ZO services as an in-network benefit to more than 10 million additional patients throughout the country. These wins have included removing MCT as an investigational benefit and recognizing the clinical value of 14-day monitoring.

Our next generation Zeo MCT product for which we expect to file the 510(k) this quarter is designed to significantly enhance our competitive position in this large, underpenetrated market. Key improvements we intend to submit to the FDA include moving Zeo MCT onto the same form factor as Zeo Monitor, with a smaller footprint, better adhesion, and extended battery life, extending wear time from 14 days to 21 days, and advanced software for enhanced detection parameters, along with an improved final wear report. While we're encouraged by the success of our Zo AT service, we believe that our next generation MCT or Zoom...

Key could be even better for a customer and their patients.

Quentin Blackford: Turning to markets outside of the United States, we continue to make steady progress in the UK, four additional European markets, and in Japan. In Japan, we have launched eight new commercial accounts since our second quarter commercialization with positive feedback from physicians to date. We're recruiting patients for retrospective and prospective studies to compare ZO with other cardiac monitors in Japan, with the goal of demonstrating superiority of ZO over other in-country offerings. In Europe, we were pleased with another quarter of strength in the UK private market, and we've seen steady uptake in the four additional countries where we launched commercially last fall. Our teams are focused on creating market awareness through KOL engagements and on demonstrating ZO's value proposition through publications and collaborations. Looking forward, we're energized by our expanding innovation pipeline and the multiple growth vectors we're developing.

Additionally, our Market access and payer relations teams have made significant progress, expanding access to Zeo Services as an in-network benefit to more than 10 million additional patients throughout the country. These winds have included removing NCT as an investigational benefit and recognizing the clinical value of 14 day monitoring

Turning the markets outside of the United States. We continue to make steady progress in the UK for additional European markets and in Japan. In Japan, we have launched 8 new commercial accounts. Since our second quarter commercialization with positive feedback from Physicians to date, we recruiting patients for retrospective. And prospective studies to compare Zeo with other cardiac monitors in Japan, with the goal of demonstrating superiority of Zo over other in country offerings,

Used with another quarter of strength in the UK private market. And we have seen steady uptake in the 4 additional countries. Where we launched commercially last fall, our teams are focused on creating Market awareness, through K, engagements, and on demonstrating Zios value proposition through Publications and collaborations.

Quentin Blackford: Our teams are making substantial progress on next-generation capabilities, strategic partnerships, and platform enhancements that will drive both near-term performance and long-term market expansion. We're confident these investments position us to maintain our innovation leadership while capturing the significant opportunities ahead. Our strong growth trajectory is built on a foundation of operational excellence and financial discipline that positions us for sustainable scaling. We're demonstrating this commitment through our approach to regulatory excellence, submitting comprehensive responses to the FDA's warning letter and 483 observations, and implementing measures that go beyond the agency's requirements while planning a third-party audit for the second half of this year as we drive toward best-in-class quality processes. Importantly, we've expanded adjusted EBITDA margins by 500 basis points since Q2 of last year while investing aggressively in growth initiatives, demonstrating our ability to generate sustainable operating leverage.

Looking forward. We're energized by expanding Innovation pipeline in the multiple growth vectors. We're developing our teams are making substantial progress on Next Generation capabilities, strategic Partnerships and platform enhancements that will drive both near-term performance and long-term Market expansion. We're confident these Investments position us to maintain our Innovation leadership while capturing the significant opportunities ahead.

Quentin Blackford: This performance reflects our disciplined approach to process optimization, strategic automation deployment, and focused investment in financially attractive growth opportunities. With that, I'll now turn the call over to Dan to discuss our recent financial performance and updated outlook. Thank you, Quentin. As a reminder, unless otherwise noted, the financial metrics that I discussed 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. We delivered strong, profitable growth in the second quarter of 2025, with revenue of 186.7 million, up 26.1% year-over-year, combined with an adjusted EBITDA margin of 8.4%. This marks our third consecutive quarter of 20% plus year-over-year revenue growth while driving 500 basis points of adjusted EBITDA margin improvement.

Our strong growth trajectory is built on a foundation of operational excellence, and financial discipline that positions us for sustainable scaling. We're demonstrating this commitment through our approach to regulatory Excellence submitting comprehensive responses to the fda's warning letter and 483 observations and implementing measures that go beyond the agency's requirements while planning a third-party audit for the second half of this year, as we drive toward best-in-class quality processes importantly, we've expanded adjusted, Evita margins by 500 basis points since Q2 of last year while investing aggressively in growth initiatives. Demonstrating, our ability to generate sustainable operating leverage, this performance, reflects our disciplined approach to process optimization, strategic Automation and focused investment in financially attractive growth opportunities with that. I'll now turn the call over to Dan to discuss our recent financial performance and updated Outlook.

Thank you Quinton as a reminder, unless otherwise noted, the financial metrics that I discussed 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, we delivered strong profitable growth. In the second quarter, 2025 with revenue of 186.7 million up 26.1% year-over-year combined with an adjusted ebaa margin of 8.4%.

Quentin Blackford: Volume growth was robust across both product lines, driven by continued strength from our core business, strong ZOAT mix, and contributions from innovative channel accounts. New store growth, with new stores defined as accounts that have been open for less than 12 months, accounted for approximately 68% of our year-over-year volume growth. Home enrollment for ZO services in the US was approximately 23% of volume in the second quarter. Moving down the P&L, gross margin for the second quarter was 71.2% ahead of our expectations. Compared to second quarter 2024, improvement to gross margin was driven by volume leverage and continued benefit from operational efficiencies, offsetting the higher blended cost per unit from increased ZOAT product mix.

This marks our third consecutive quarter of 20% plus year-over-year. Revenue growth while driving 500 basis points of adjusted IBA, margin Improvement. Volume growth was robust across both product lines, driven by continued strength, from our Core Business. Strong zo a team mix and contributions from Innovative Channel accounts. New store growth with new stores defined as accounts that have been open for less than 12 months, accounted for approximately 68% of our year-over-year, volume growth.

Home enrollment for Zio services in the US was approximately 23% of volume in the second quarter.

Quentin Blackford: Second quarter adjusted operating expenses were 145.2 million, a 16% increase year-over-year, primarily driven by our ongoing remediation activities, incremental expenses to support our global volume growth, and funding of innovation and commercial growth initiatives. These purposeful investments were enabled by savings generated from operational excellence initiatives, which demonstrate our ability to deliver top-line growth while generating meaningful operating leverage. Adjusted net loss in the second quarter of 2025 was 10.2 million, or an adjusted net loss of 32 cents per share, compared to an adjusted net loss of 18.8 million, or an adjusted net loss of 61 cents per share in the second quarter of 2024. Adjusted EBITDA in the second quarter of 2025 was 15.7 million, equating to an adjusted EBITDA margin of 8.4% of revenue, compared to an adjusted EBITDA margin of 3.4% in the second quarter of 2024.

Moving down the p&l gross margin for the second quarter was 71.2% ahead of our expectations. Compared to second quarter 2024 Improvement to gross margin was driven by volume leverage and continued benefit from operational efficiencies. Offsetting the higher Blended cost per unit from increased zoat product mix.

Second quarter adjusted. Operating expenses were 145.2 million, a 16% increase year-over-year, primarily driven by our ongoing, remediation activities incremental, expenses to support our Global volume growth and funding of innovation and Commercial. Growth initiatives. These purposeful Investments were enabled by savings generated from. Operational excellence initiatives which demonstrate our ability to deliver Topline growth while generating meaningful operating Leverage.

Adjusted net loss in the second quarter of 2025 was 10.2 million or an adjusted. Net loss of 32 cents per share, compared to an adjusted, net loss of 18.8 million, or an adjusted, net loss of 61 cents per share in the second quarter of 2024,

Quentin Blackford: This 500 basis point improvement in adjusted EBITDA profitability is the direct result of robust top-line growth combined with thoughtful and intentional initiatives that we have implemented to drive sustainable efficiency at scale. Adjusted EBITDA in the second quarter of 2025 included 1.7 million of IP R&D expense. As noted in prior quarters, we continue to incur incremental legal and consulting fees, as well as other company expenses related to FDA remediation efforts and DOJ subpoena activities. We continue to expect these incremental remediation expenses will be approximately 15 million in 2025. Turning to guidance, we're raising full-year 2025 revenue guidance to 720 to 730 million due to first-half outperformance, continued momentum in our core business, sustained AT strength, and contribution from innovative channels. This outlook includes significant US volume growth, with pricing now expected to be flat compared to prior year.

Adjusted IBA in the second quarter of 2025 was $15.7 million, equating to an adjusted EBA margin of 8.4% of revenue compared to an adjusted EBIT margin of 3.4% in the second quarter of 2024. This 500 basis point improvement in adjusted EBA profitability is the direct result of robust top-line growth combined with thoughtful and intentional initiatives that we have implemented to drive sustainable efficiency at scale.

Adjusted IBA and the second quarter of 2025 included, 1.7 million of Ip R&D expense.

As noted in prior quarters, we continued to incur incremental legal and consulting fees, as well as other company expenses related to FDA remediation efforts and DOJ subpoena activities. We continue to expect these incremental remediation expenses will be approximately $15 million in 2025.

Quentin Blackford: We expect third quarter 2025 revenue to be slightly down compared to the second quarter, consistent with normal seasonality. For gross margin, we now anticipate full-year 2025 gross margin to slightly exceed full-year 2024 gross margin as clinical operations and manufacturing efficiencies largely offset proposed tariffs on global imports. We anticipate that third quarter gross margin will decline slightly from second quarter due to hiring within our clinical operations teams ahead of anticipated volume growth. We estimate that the negative impact to gross margins from tariffs will be approximately negative 20 to 40 basis points for the full year, with the impact more weighted in the back half of the year. This impact is slightly below our prior estimates, with incremental clarity on tariffs moving forward and as our teams have executed supply chain strategies to mitigate potential impacts from tariffs.

Second quarter, consistent with normal seasonality.

For gross margin. We now anticipate full year, 2025 gross margin to slightly exceed full year 2024 gross margin as clinical operations and Manufacturing efficiencies largely offset proposed tariffs on Global Imports. We anticipate that third quarter, gross margin will decline slightly from second quarter due to hiring within our clinical operations, teams ahead of anticipated. Volume growth.

Quentin Blackford: As mentioned previously, we're strategically building raw material inventory to mitigate potential supply chain disruptions, creating a slight headwind to free cash flow. We're updating our full-year 2025 adjusted EBITDA margin guidance to 8 to 8.5% of revenues. As noted previously, adjusted EBITDA continues to absorb acquired IP R&D expenses, tariff impacts, and FDA remediation expense. We are leveraging our increase to revenue guidance as an opportunity to accelerate planned development projects and investments into infrastructure, such as clinical software tools and AI, to fuel long-term operational efficiencies and margin accretion. We expect adjusted operating expenses to decline in the second half of the year due to front-loaded corporate activities and payroll costs, offset by reinvestments and increased regulatory audit activities. We expect third quarter 2025 adjusted EBITDA margin to range between 9 and 9.5%.

We estimate that the negative impact to gross margins from tariffs will be approximately -20 to 40 basis points for the full year with the impact more weighted, in the back half of the Year. This impact is slightly below our prior estimates with incremental Clarity on tariffs, moving forward. And as our teams have executed supply chain strategies to mitigate potential impacts from tariffs,

As mentioned previously, we're strategically building raw material inventory to mitigate potential supply chain disruptions creating a slight headwind to free cash flow.

We're updating our full year 2025 adjusted, Eva de margin guidance, to 8, to 8 and a half percent of revenues as noted previously, adjusted ebit. Doc continues to absorb acquired IP R&D expenses, tariff impacts and FDA, remediation expense. We are leveraging our increase to revenue guidance as an opportunity to accelerate planned development projects and investments into infrastructure such as clinical software tools, and AI to fuel. Long-term operational efficiencies and margin accretion.

We expect adjusted operating expenses to decline in the second half of the year due to front-loaded corporate activities and payroll costs offset by reinvestments and increased regulatory audit activities.

Quentin Blackford: Finally, we ended the third quarter in a strong financial position with 545.5 million in unrestricted cash on hand. For full-year 2025, we continue to anticipate being slightly free cash flow negative and anticipate becoming free cash flow positive for full-year 2026. This expectation has taken into consideration the cash flow impact from inventory buildup of raw materials, as well as prioritized investments into infrastructure and next-generation technology platforms. Before closing, I'd like to comment on the recently issued physician fee schedule as proposed by the Centers for Medicare and Medicaid Services, or CMS, for calendar year 2026. While still preliminary at this time, we estimate that the applicable CMS rates in 2026 versus 2025 will be flat to slightly up for ZO Monitor and up approximately 2% for ZOAT. As a reminder, CMS represents approximately 24% of total company revenues.

We expect third quarter, 2025 adjusted, EBA margin to range between 9 and 9, and a half percent.

Finally, we ended the third quarter in a strong financial position with 545 and a half million in unrestricted. Cash on hand for full year 2025, we continue to anticipate being slightly free cash flow negative and anticipate becoming free cash flow positive for full year 2026. This expectation has taken into consideration. The cash flow impact from inventory buildup of raw materials, as well as prioritized Investments and to infrastructure and Next Generation technology platforms.

Quentin Blackford: We will provide further commentary following the CMS final rule expected in November. In closing, we were very pleased with the financial results from the second quarter of 2025 and the continued momentum in our business. Our teams are focused on delivering profitable growth, and we are strategically investing in the opportunities to grow our business into the future. We see a balanced set of near and long-term growth drivers and are well-positioned to deliver sustainable profitability as we continue to execute on our operational excellence initiatives. I will now turn the call back to Quentin for closing remarks. Thanks, Dan, and thank you all for your continued support of Irhythm today. The first half of 2025 demonstrated exceptional execution and the accelerating recognition of Irhythm's transformative value proposition across the healthcare ecosystem.

Before closing, I'd like to comment on the recently issued Physician Fee Schedule as proposed by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2026. While still preliminary, at this time, we estimate that the applicable CMS rates in 2026 versus 2025 will be flat to slightly up for Zeo Monitor and up approximately 2% for Zio. As a reminder, CMS represents approximately 24% of total company revenues. We will provide further commentary following the CMS final rule expected in November.

In closing, we are very pleased with the financial results from the second quarter of 2025 and the continued momentum in our business. Our teams are focused on delivering profitable growth, and we are strategically investing in opportunities to grow our business into the future. We see a balanced set of near- and long-term growth drivers and are well-positioned to deliver sustainable profitability as we continue to execute on our operational excellence initiatives. I will now turn the call back to Clinton for closing remarks.

Quentin Blackford: We remain convinced that the ambulatory cardiac monitoring market represents a largely untapped opportunity with substantial growth potential validated by our momentum across our core business, including both ZO Monitor and ZOAT, innovative channels, and international markets. ZO's clinically validated platform uniquely positions us to lead the transformation of cardiac care through proactive monitoring that enables truly preventative interventions. Our technology empowers healthcare providers to shift from reactive to preventative care by identifying critical rhythm abnormalities before they manifest as serious cardiac events, while our AI-powered analytics enable precision care pathways that improve outcomes and reduce cost. This approach addresses one of healthcare's greatest challenges: shifting diagnosis earlier in the care journey to prevent costly emergency interventions while alleviating system capacity constraints. As we expand globally and enhance our platform capabilities, our scalable foundation positions us to drive the clinical insights that will power value-based population health management.

Thanks Dan, and thank you all for your continued support of ithm today. The first half of 2025, demonstrated, exceptional execution, and the accelerating recognition of Ireland's. Transformative value proposition across the healthcare ecosystem. We remain convinced that the ambulatory cardiac monitoring Market represents a largely untapped opportunity with substantial growth potential validated by our momentum across our Core Business, including both Zeo Monitor and zoat Innovative channels. And international markets, Zeo is clinically validated platform, uniquely positions us to lead the transformation of Cardiac Care through proactive, monitoring, that enables truly preventive. Interventions, our technology, empowers Healthcare Providers to shift from reactive to preventative care, by identifying critical Rhythm abnormalities before they manifest, a serious cardiac events. While our AI powered analytics enabled, Precision, Care, Pathways, that improve outcomes and reduce cost.

Quentin Blackford: We're achieving this while maintaining an unwavering commitment to operational excellence and regulatory compliance. Our financial discipline, evidenced by more than 500 basis points of adjusted EBITDA margin improvement while investing in growth, demonstrates sustainable scaling with clear visibility to free cash flow generation. This combination of market opportunity, clinical differentiation, and operational excellence creates a compelling foundation for long-term value creation. We're confident in our trajectory toward market leadership and grateful for your continued support as we transform cardiac care globally. Operator, we're now ready for questions.

This combination of Market opportunity, clinical differentiation, and operational excellence, creates a compelling foundation for long-term value, creation for confident, in our trajectory toward Market, leadership, and grateful for your continued support as we transform Cardiac Care globally, operator. We're now ready for questions.

Operator: Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by two. Again, to ask a question, please press star one. We do ask that you limit yourself to one question, and if you would like to ask a follow-up, please join the queue again. We will begin with our first question from the line of Alan Gong with JP Morgan. Please go ahead.

Thank you.

If you would like to ask a question, please press star followed by 1 on your telephone keypad. If for any reason you would like to remove that question, please press star followed by 2. Again, to ask a question, please press star 1. We do ask that you limit yourself to one question, and if you would like to ask a follow-up, please join the queue again. We will begin with our first question from the line of Allan Gong with JP Morgan. Please go ahead.

Analyst: Thanks for the question. Congratulations on a really good quarter. So, you know, I guess my first question is really going to fall on the guide, right? You clearly saw a lot of upside in the quarter. It came in a little over 10 million above consensus for the second quarter, and you're raising your full-year guide, basically pulling that kind of strength forward into the third quarter and fourth quarter. I know you said on the first quarter call you wanted to maintain some conservatism around some of the innovative partnerships you were making, and clearly that's starting to contribute. But when we think about, you know, the difference between the bottom of your new guidance at 720, the top at 730, and then the potential for outperformance at the top, you know, above that, how should we think about the drivers of that?

Thanks for the question. Congratulations on a really good quarter. So, you know, I guess, my, my first question is really going to fall on the guide, right? You clearly saw a lot of upset in the quarter came in a little over 10 million above consensus for second quarter and you're raising your full year guide, basically, pulling that kind of strength forward in the third quarter and fourth quarter. I know you said on the first quarter call, you wanted to maintain some conservatism around some of the Innovative Partnerships you were making and clearly that's starting to contribute but when we think about, you know, the difference between the bottom of your new

28 is the top at 7:30, and then the potential for outperformance at the top.

Above that.

Or should we think about the drivers of that?

Dan Wilson: Yeah, thanks, Alan. Appreciate the question and being on the call here. Look, clearly there's a lot of momentum in the business right now that has us very excited. I think the one thing I do want to be really clear about is our approach to how we think about guidance has not changed at all. We continue to set expectations that we feel highly confident in being able to deliver, and this latest revision of that guidance reflects the same philosophy. So we're not thinking about it any differently. You know, to your point, we raised guidance last quarter by roughly 15 million on the year. This quarter, we're raising roughly 30 million on the year. It's not about, you know, introducing incremental risk. I think it's more about acknowledging the strength that we see coming across the business, really across all sectors of it.

Dan Wilson: You know, in Q2 alone, we beat by our numbers roughly 12 million. We raised the back half of the year by, call it 18 million, which is roughly $9 million in Q3 and Q4, which, you know, to us is a measured step up from what we're already seeing. And if you look at Q2, the momentum within the quarter was really strong, particularly towards the back half of it. So just a lot of strength in the quarter itself and really accelerating over the course of the quarter. When you think about the drivers, you know, the core business continues to be the biggest driver this far and away. Yes, innovative channels did contribute and contributed nicely, but the core business is where we saw the majority of the outperformance in the quarter itself.

Yeah, thanks Ellen. Appreciate the question and uh, and being on the call here. Well clearly there's a lot of momentum in the business right now that has us very excited. I think the 1 thing I do want to be really clear about is our approach to how we think about guidance has not changed at all, we continue to set expectations that we feel highly confident and being able to deliver. And this latest revision of that guidance, reflects the same philosophy so we're not thinking about it any differently, you know, to your point. We raised guidance last quarter by roughly 15 million on the Year, this quarter, we're raising roughly 30 million on the year. It's not about, you know, introducing incremental risk. I think it's more about acknowledging. The strengths that we see coming across the business or really across all sectors of it. You know, in Q2 alone we beat by by our numbers roughly 12 million. We raised the back half of the Year by call, it 18 million, which is roughly 9 million dollars in Q3 and Q4 which, you know, to us is a measured step up from what we're already seeing and if you look at Q2 the momentum within the quarter was, was really

Dan Wilson: And when we think about the full-year increase of 30 million, I would say, you know, roughly two-thirds of that is coming out of the core business, which is being fueled by both strong execution from our commercial team and our EHR integration teams, but onboarding of new accounts as well that are just meaningful in size and have quickly transitioned into some of our largest accounts. So the core business is performing incredibly well. I would tell you ZOAT continues to perform exceptionally well. I think the competitive disruption that we saw there late last year initially helped turn attention towards AT, but I think the momentum we see in that business right now is more sustained, especially in accounts where we've built strong integrations.

Really strong, particularly towards the back half of us. So just a lot of strength uh in the quarter itself and and really accelerating over the course of the quarter. When you think about the drivers, you know, the Core Business continues to be the the biggest driver of this far and away. Yes, Innovative channels did contribute, it contributed nicely but the core business is where we saw the majority of the outperformance in the quarter itself. And when we think about the full year, increase of 30 million, I would say, you know, roughly 2/3 of that is coming out of the Core Business, which is being fueled by most strong execution, from our commercial team, and our EHR integration teams, but on boarding of of new accounts as well that are just uh meaningful in size and they have quickly transitioned into some of our largest accounts. So uh the core business is performing incredibly well. I would tell you zoat continues to perform exceptionally. Well. Um I I think the competitive disruption that we saw their late last year initially helped turn attention towards at but I think the the momentum we see in that business right now is is more sustained.

Dan Wilson: We see our new customers coming on, you know, deploying both ZO Monitor and ZOAT at the same time, much to a much greater degree than what we had seen in the past. And so we're highly confident in that business. And then to your point on innovative channels, we certainly saw a bit of outperformance in the second quarter. We've guided a bit of an increase. I'd say about a quarter of the increase on the full year is coming out of innovative channels. I spoke about the fact that we increased our prescribing physicians with Signify by nearly 1,000 physicians in the quarter itself. We just got launched with Centerwell, and we just re-upped the contract with the partner in the fourth quarter that we had talked about, you know, a couple of quarters ago that we'll begin patching in the back half of the year.

Especially in accounts where we've built strong Integrations. We see our new customers coming on deploying both Zeo Monitor and Zeo at the same time much, uh, to a much greater degree than what we had seen in the past. And so we're we're highly confident in that business and then to your point on Innovative channels. We, we certainly saw a bit of outperformance in the second quarter. Um, we've guided a bit of an increase, I'd say about a quarter of the increase, on the full year is coming out of innovative channels. I spoke about the fact that we increased our our prescribing

Dan Wilson: So continue to feel really good about, you know, the guide overall. You know, I would set it out there that it's not our intent to beat the guide each quarter by, call it, 10 to 12 million dollars, but it is about setting up a guidance expectation that we feel very good we can execute against and deliver, and if we execute well, outdeliver.

Physicians with Signify by nearly a thousand, uh, physicians in the quarter itself. We just got lost with CenterWell, and we just, uh, re-upped the contract with the partner in the fourth quarter that we had talked about, you know, a couple quarters ago, that we'll begin patching in the back half of the year. So we continue to feel really good about, you know, the guidance overall. Um, you know, I would set it out there that, uh, it's not our intent to be the guy at each quarter by, call it, $10 to $12 million. But it is about setting up a guidance expectation that we feel very good we can execute against and deliver. And if we, uh, execute well, out-deliver.

Operator: Thank you. Our next question comes from the line of Joanne Wunch with Citigroup. Please go ahead.

Thank you.

Please go ahead.

Analyst: Hey, this is actually Antoinette for Joanne. Thank you for taking the questions. Just a quick follow-up on the previous question. Are you able to share what in the quarter, what the volume contribution was from those innovative channel partners and then the 40 accounts that you're sort of in active discussions with? Can you give any maybe timeline on when you expect those to come online? Thank you.

Uh, hey, this is Ashley Anthony for Joan. Thank you for taking the questions. Um, just a quick follow-up on the previous question. Um, are you able to share what, in the quarter, the volume contribution was from those Innovative Channel partners and then the 40 accounts that you're sort of in active discussions with? Can you give maybe a timeline on when you expect those to come online? Thank you.

Dan Wilson: Yeah, we're not going to break out the actual contribution from the innovative channel partners. We gave you a peek into that last quarter. We said it was about 3% of total revenue. I can tell you that stepped up in Q2 and exited the quarter, you know, even higher. As we continue to bring these folks on and they continue to prescribe more, you know, on a daily basis, relative to the 40 accounts that are out there, I think it'll be a nice steady cadence over the remainder of the year and into next year. I'm not going to guide in terms of how quickly and what number we expect within the next, you know, quarter itself. I think we want to continue to get some experience here and see how that comes together.

Dan Wilson: I am excited by the Lucem announcement that we made relative to, you know, the AI partnership. I think it speaks directly to the innovative channel partners incredibly well, where we can get into those innovative channel partners' medical data history sets, you know, of their patients, identify through algorithms which ones are likely to have arrhythmias, and then get patches on those folks. Early results coming out of some of these pilots with the Lucem algorithm is remarkable, where we find yields of 80 to 90% hit rates in terms of patients who had no idea they might have had an arrhythmia do, in fact, have an arrhythmia that needs to be treated. So we're excited by it. We'll update you as we go, but I'm not going to give a specific number this quarter. I'll just tell you it stepped up from where it was at in Q1.

Yeah, what I what I'm not going to break out the actual contribution from the Innovative Channel Partners. We gave you a peek into that last quarter. We said it was about, 3% of total revenue. I can tell you that stepped up in Q2 uh, and exited the quarter, you know, even higher uh, as we continue to bring these folks on and they continue to prescribe more, you know, on a daily basis relative to the 40 accounts that are out there. I I think it'll be a nice steady Cadence over the the remainder of the year and into next year, um, I'm not going to guide in terms of how quickly and what number we expect within the next, you know, quarter itself. I think we want to continue to get some experience here and see how that comes together. I am excited by the lusome announcement that we made relative to, you know, the AI partnership. I think it speaks directly to the Innovative Channel, Partners, incredibly well, where we can get into, uh, those Innovative Channel Partners. Medical Data, history sets, you know, of their patients identify through algorithms, which ones are likely to have arrhythmias and then get patches on those folks, uh, early results coming out of

Some of these Pilots with the lusome algorithm is its remarkable where we find yields of 80 to 90% hit rates. In terms of patients who had no idea, they might have had an arrhythmia due in fact, having arrhythmia that needs to be treated. So we're excited by it, we'll update you as we go. But um not going to give a specific number this court. I'll just tell you, it stepped up from from where it was at in q1.

Operator: Thank you. Our next question comes from the line of Brandon Vasquez with William Blair. Please go ahead.

Thank you.

Our next question, Council. On the line of Brandon Vasquez with William Blair, please go ahead.

Quentin Blackford: Hey, everyone. Thanks for taking the questions and congrats on a nice quarter here. Quentin, I was really intrigued by the comment that you had made about when you're getting into these Epic accounts, you're actually seeing increased volumes as you go and you integrate into the account. So maybe can you spend a minute just talking about what does that look like? Where are these incremental patients coming from? Why are you seeing increased volumes? And if possible, I'll stretch and try to ask, are there any numbers you can give us on how big that opportunity is and like what the incremental patients are? But any color around that would be helpful. Thank you.

Hi everyone. Thanks for taking the the questions and congrats on a nice quarter here. Uh, Quinton, I was really intrigued by your comment that you had made about when you're getting into these epic accounts. You're actually seeing increased volumes as you go. Uh, and you integrate into the account. So maybe, can you spend a minute just talking about? What does that look like? Where are these incremental patients coming from? Why are you seeing increased volumes? And if possible I'll I'll stretch and try to ask. Are there any numbers you can give us on how big that opportunity is and like what the incremental patients are? Uh, but any, any color around? That would be helpful. Thank you.

Dan Wilson: Yeah, look, we've been really pleased with the integrations around the Epic opportunity. They've been a terrific partner. We've got a team internally who's dedicated entirely to the Epic integrations, and we're moving as quickly as we can, and that team's done a phenomenal job. As I mentioned, we've got, you know, north of 40 accounts actively in integrations in that pipeline and continues to build. And so we're super excited by it. I would say that the contribution in the second quarter from Epic didn't really lead to outperformance. We're still in the very early stages of getting these accounts onboarded. We really just started to open it up at the beginning of the year, but we see some really promising trends in those accounts that we're integrating. I would tell you, on average, we see, you know, north of 20% increase in prescribing patterns post-integration.

Dan Wilson: Some accounts even as high as 40%. So we'll monitor it as we go. We're super bullish on the opportunity here with Epic. We understand the value of the streamlined workflow. What we like to see is when we get integrated with these accounts, not only are they integrating, you know, ZO Monitor, but ZOAT quickly comes along and we become a single solution for an entire system, which is nice to see. In terms of the size of the opportunity, you know, I would just tell you 65% of our accounts that are integrated are using EMRs or roughly Epic related. So there's a tremendous opportunity in the current, you know, customer population that are already using Epic to integrate with Aurum.

Yeah, look we've been really pleased with the Integrations around the Epic opportunity. They've been a terrific partner, we've got a team internally who's dedicated entirely to the Epic Integrations, and we're moving as quickly as we can and that team's done a phenomenal job. Um as I mentioned we've got, you know north of 40 accounts actively in Integrations uh, in that Pipeline and and continues to build and so we're super excited by it. I would say that the the contribution of the second quarter from epic, didn't really lead to outperformance. We're in the, we're still in the very early stages of getting these accounts on board and we really just started to open it up at the beginning of the year, but we see some really promising Trends in those accounts that were integrating. I would tell you on average we see you know north of 20% increase in prescribing Pasa patterns uh post integration. Um some accounts even as high as 40%. So we we'll monitor it as we go. We're super bullish on the opportunity here with with epic. We understand that the value of the streamlined workflow, uh,

what we like to see is when we get integrated with these accounts, uh, not only are they integrating, you know, Zeo monitor, but zoat quickly comes along and and we become a single, uh, solution for an entire system which is is nice to see.

In terms of the size, the opportunity, you know, I would just tell you 65% of our accounts um, that are integrated are using uh, emrs or or roughly epic related. So, there's a tremendous opportunity in the current, you know, uh, customer population that are already using uh, epic to integrate with aura.

Operator: Thank you. Our next question comes from the line of Marie V. Balt with BTID. Please go ahead.

Thank you.

Our next question comes from the line of Murray the bolts with btig. Please go ahead.

Analyst: Hi, good evening. Thanks for taking the questions and great quarter. Wanted to ask for a little bit more detail here. You told us a little bit about the drivers of the guidance raise going forward. I think I heard two-thirds from core and new accounts and a quarter of it from increasing from innovative channels. What was a little bit of difference there? The ZOAT, I'm guessing, might have been part of it. And can you give us a similar breakout for what drove the outperformance in Q2? Just very curious about the details there.

In Q2 just very curious about the details there.

Dan Wilson: Yeah, I would tell you the outperformance in Q2 is very similar to how we thought about the raise on the full year. So the core business drove the majority of that outperformance in the quarter. ZOAT and innovative channels sort of contributed in an equal way the remainder of that delta. And that's the way to think about the full-year guide.

Dan Wilson: So of the $30 million increase in the full year, call it roughly 20 from the core business, and the other 10 was spent relatively evenly between ZOAT and innovative channels, which, you know, when you look at the outperformance in the second quarter, compare that to the guide for the full year, the amount of incremental or increase in the guidance that we put through in Q3 and Q4 relative to ZOAT and innovative channel partners is actually a bit less than what the beat was in Q2. So continue to hold back there a bit of our optimism. We want to continue to see that play out, but we continue to like this setup relative to those two opportunities.

Yeah, I would tell you the outperformance in Q2 uh is very similar to how we thought about the Rays on the full year. So the Core Business drove, the majority of that outperformance in the quarter zoat and and Innovative channels, sort of contributed in an equal way, the remainder of that Delta. And that's the way to think about the full year guide. So of the, the 30 million dollar increase in the full year, call it roughly 20 from The Core Business, and the other 10 was spent relatively evenly between 08 and and Innovative channels, which, you know, when you look at the outperformance in the second quarter, uh, compare that to the, the guide for the full year, um, the amount of incremental, uh, or increase in the guidance that we put through in Q3 and Q4 relative to zoat and Innovative Channel Partners is actually a bit less than what the the beat was in Q2. So continue to to hold back there. A bit of our optimism. We want to continue to see that play out, uh but we continue to like that, with this setup uh relative to those 2 opportunities.

Operator: Thank you. Our next question comes from the line of Nathan Trebek with Wells Fargo. Please go ahead.

Thank you.

Our next question comes from the line of Nathan Trebek with Wells Fargo. Please go ahead.

Analyst: Hi, thanks for taking the question and congrats on a pretty strong quarter. Can you say if there are maybe one or two key innovative partnerships of this wealth that you disclosed that are kind of underpinning this growth outlook? And in terms of reorder rates in these accounts, what are you seeing? How sustainable is it? Thanks.

Hi. Uh thanks for taking the question and congrats on a pretty strong quarter. Um, C, can you say if there if there are maybe 1 or 2 key key, Innovative Partnerships of of the 12 that you disclose that are kind of underpinning this growth Outlook and in terms of reorder rates in these accounts, what what are you seeing as sustainable? Is it thanks.

Dan Wilson: Yeah, I will tell you, you know, Signify, we've talked quite publicly about. They've been an outstanding partner here. They certainly are contributing very nicely. Centerwell that I just announced, you know, in my prepared remarks has very quickly stepped up, is going to be a meaningful contributor in this innovative channel partners. We've talked about Oak Street in the past. You know, they've been our longest partner in this innovative channel partner opportunity, but they continue to prescribe at very healthy rates. I think one of the things that's really encouraging to us as we continue to get closer to these partners of ours is just learning about their prescribing patterns.

Dan Wilson: You know, I think what we're learning is most of these folks expect this to be a repeat monitoring sort of opportunity into the future, where whether they're retesting every single year their patient population to try to stay ahead of the asymptomatic, you know, population that is just completely unaware and avoid those catastrophic downstream events, or they're signing up new patients who are coming in all the time. There's going to be a continuous repeat sort of prescribing pattern with these innovative channel partners that excites us. And I think, again, it just speaks to the optimism about the future here. When we talk about a 27 million patient opportunity, you know, the majority of those are asymptomatic or symptom-confused. Many of them are experiencing comorbid disease states, type 2 diabetes, COPD, CKD. A lot of times, they're confusing symptoms with true arrhythmias.

I will tell you uh you know signify we've talked quite publicly about they've been an outstanding partner here. Um they they certainly are contributing very nicely Center. Well that that I just announced, you know, in my prepared remarks is very quickly, stepped up um is going to be a meaningful contributor in this Innovative Channel Partners. Uh we've talked about Oak Street in the past. You know they've been our longest partner in this Innovative Channel partner but uh opportunity but they continue to to prescribe it very healthy rates. I think 1 of the things that's really encouraging to us as we continue to get closer to. These partners of ours is is just learning about their prescribing patterns. You know, I think what we're learning is most of these folks expect this to be a repeat monitoring sort of opportunity into the future where whether they're retesting every single year their patient population to try to stay ahead of the asymptomatic. You know, population that um, is just completely unaware and avoid those catastrophic Downstream uh, events or they're signing up, new patients, who are coming in all the time. There's going to be a

Dan Wilson: We need to find those patients, and the way to find them is through innovative channel partners, which is why, you know, we've got a big bolus of targeted accounts that we're in conversations with, and we've got a whole list behind that that we'll continue to step into as well. But couldn't be more excited about the innovative channel opportunity as we move into the future.

Us repeat, uh, sort of prescribing pattern with these Innovative Channel partners that excites us. And and I think again just uh, speaks to the optimism about the future here when we talk about a 27 million patient opportunity, you know, the majority of those are asymptomatic or symptom confused. Many of them are are experiencing comorbid disease States type 2 diabetes COPD CKD. A lot of times they're confusing symptoms uh, with with true arrhythmias. Um, we need to find those patients and the way to find them is through Innovative Channel Partners, which is why, you know, we've got a big bolus of targeted accounts that we're in conversations with, uh, and we've got a whole list behind that, that we'll continue to step into as well, but couldn't be more excited about Innovative Channel opportunity, as we move into the future.

Operator: Thank you. Our next question comes from a line of David Roman with Goldman Sachs. Please go ahead.

Thank you.

Our next question comes from the line of David Roman with Goldman Sachs. Please go ahead.

Analyst: Thank you, and I appreciate your taking the question. I know, Dan, you talked about the physician fee schedule and impacted direct reimbursement, but I was hoping maybe if you had any preliminary thoughts on the ambulatory specialty model proposal that came out that appears to have some incremental incentives associated with early detection. I know that is not expected to go into place until 2027, but maybe any early thoughts on that and how that might be a source of incremental demand on the forward.

I appreciate your you're taking the question. I I Know Dan you talked about the uh,

The Physician fee schedule and it impacted director reimbursement, but I was hoping maybe if you had any preliminary thoughts on the ambulatory specialty model proposal that came out that appears to have some incremental incentives associated with early detection. I know that is not expected to go into place until 2027, but maybe any any early thoughts on that and how that might be a source of of incremental delay.

and on the Ford,

Dan Wilson: Yeah, David, good question. It's Dan here. We are aware of that. Our teams are certainly looking into that as we think about what's on our product roadmap, what those opportunities are for securing additional reimbursement. We'll see what ultimately gets finalized in the final rule, but it is something we're exploring. We're excited about those types of initiatives being brought forward on the fee schedule, and we'll be exploring those into the future.

Quentin Blackford: I think ultimately, David, those create greater awareness in and around, you know, disease, disease state, and prevalence of it. And the more we create awareness, I think the greater lead opportunity it ends up being into our product ultimately.

Yeah, we David? Good question is Dan, here we are aware of that. Um, our teams are certainly, um, looking into that as we think about what's on our product roadmap, what those opportunities are for, um, securing additional reimbursement. Um, we'll see what ultimately gets finalized in in the, you know, the final rule, but it is something we're exploring. We're excited about um those types of initiatives being brought forward uh, on the fee schedule and we'll be exploring those into the future.

I think ultimately David, those create greater awareness in and around, you know, disease disease State, um, and prevalence of it. And the more we created awareness, I think the greater uh, lead opportunity that ends up being into our product, ultimately,

Operator: Thank you. Our next question comes from the line of David Saxon with Needham & Company. Please go ahead.

Thank you.

Our next question comes from the line of David Saxon with Needham & Company. Please go ahead.

Analyst: Great. Good afternoon, Quentin and Dan. Thanks for taking my question and congrats on my quarter. I wanted to ask about guidance, and it's a two-parter. So third quarter, I think, Dan, you said you're expecting it to be down sequentially due to seasonality, and that all makes sense. But I look back and, except for last year, you were able to grow through that seasonality, and last year, you were flat. Quentin, you talked about growth or strength accelerating into the second half quarter. So I guess, you know, it sounds like the momentum should continue. So why would third quarter be down sequentially? And, you know, if it in fact is, can you give us some guardrails around, you know, what that sequential growth might be?

Great, uh, good afternoon, Quinton and Dan. Thanks for taking my question and congrats with my quarter. I wanted to ask about guidance and it's a 2-part. Um, so third quarter, I think and you, you said, you're expecting it to be down sequentially, um, due to seasonality, and that'll make sense. But I I look back and

Analyst: And then the second part of the question is just around that renewed partnership with the channel partner you saw in fourth quarter. If memory serves, that was a very lumpy partner with their monitoring. So is that how to think about their go-forward cadence, or should it be smoother or more gradual going forward? Thanks so much.

Except for last year, you were able to grow through that seasonality and and last year you were flat Clinton. You talked about growth uh or strength accelerating into the second half quarter so I guess you know it sounds like the momentum should continue. So why would uh third quarter be down to sequentially? And and you know if it in fact is can can you give us some guard rails around? You know what that sequential, uh, growth might be. And then um the second part of the question is just around that renewed partnership with the channel partner. You saw in fourth quarter if memory serves that was uh a very lumpy partner um with their monitoring. So is that how to think about their go forward kits or should it be uh, smoother or more gradual? Going forward. Thanks so much.

Dan Wilson: Yep. Hi, David. It's Dan. I'll take the first question there, and maybe Quentin will take the second one. So I did say Q3 revenue down slightly. You can think of that as, call it, down 1%. You're right to point out, you know, last year down a little bit less than that 1% and growing through that in prior years. You know, I do, seasonality is real in our business, right, as physicians and patients, you know, do go on vacation and enjoy the summer months. So that is something we're mindful of. It is something we've seen in the business. And then would also just point out, you know, with innovative channel being a bigger, you know, growing part of our business, you know, those are kind of new prescribing patterns, new patients.

Dan Wilson: And again, want to make sure we're being thoughtful in terms of, you know, how we're thinking about guide. So I believe that's the right way to think about it, that down 1% for Q3. And then I'll let Quentin address the second question.

Quentin Blackford: Yeah, I would just, I would add to that. You know, we're bringing that Q3 number up by, call it, roughly $9 million, right? So it's still a meaningful improvement in the Q3 guide and what that implies for Q4. You know, when you think about 30 million on the full year and you know what we outperformed in Q2. So obviously, we feel good about the momentum in the business. But to your point, you know, I think it demonstrates some of the thoughtfulness around how we continue to think about our guide and set up the guide to make sure that we can ultimately deliver on it. Your question around the lumpiness of the partner in the fourth quarter, I think it's a little bit too early to identify exactly what their prescribing patterns are going to be.

Yep. Hi David, it's Dan, I'll take the the first uh question there and and maybe Quinn will take the second 1. So um I did say Q3 Revenue down slightly. Um, you can think of that as call it down, 1%, you're right to point out, you know, last year down a little bit less than than that 1% and and growing through that in Prior years. Um, you know, I do seasonality is real in our business, right? Is Physicians and patients, you know, do go on vacation and, um, enjoy the summer months. So that is something we're mindful of it is something we've seen in the business and then would also just point out, you know, with Innovative Channel being a bigger, you know, growing part of our business. You know, the those are kind of new prescribing patterns, new patients. And again want to make sure we're being thoughtful in terms of, you know, how we're thinking about guide. Um, so believe that's the right way to think about it that down 1% for Q3. Um, and then I'll let Quinn address the second question. Yeah, I would just I would add to that, you know, we're bringing that Q3 number up by

Call it roughly 9 million dollars, right? So, it's still a meaningful Improvement in in the Q3 guide and and what that implies for Q4, you know, when you think about 30 million on the full year and you know what we outperformed in Q2, so, um, obviously, we feel good about the momentum and the business, but to your point, uh, you know, I think it demonstrates some of the thoughtfulness around how we continue to think about our guide and set up the guide to make sure that we can ultimately deliver on it. Uh, your question around the lumpiness of the the

Quentin Blackford: You know, what they ran in the fourth quarter was a bit of an isolated program with a targeted population that they got through very quickly. This program is to go beyond that population now and go more broadly across their entire patient set. I suspect it's probably going to be a lot less lumpy than what it was in the fourth quarter. But until we really see prescribing patterns come from that partner, you know, I think we're going to be a bit hesitant to really roll it into expectations. We just, we want to have a bit of experience behind us before we get ahead of ourselves there.

Partner in the fourth quarter. I think it's a little bit too early to to identify exactly what their prescribing patterns are going to be. You know what they ran in the fourth quarter, was a bit of a, an isolated program with the targeted population that they got through very quickly. This program is to go beyond that population now and go more broadly across their entire patient set. Um,

I suspect it's probably going to be a lot less lumpy than what it was in the fourth quarter, but until we really see prescribing patterns come from that partner, you know, I think we're going to be a bit hesitant to really roll it into expectations. We just, we want to have a bit of experience behind us before we get ahead of ourselves there.

Operator: Thank you. Our next question comes from the line of Richard Neuwidder with Truist. Please go ahead.

Thank you.

Our next question comes from the line of Richard. The winner with truist, please go ahead.

Analyst: Hi, thank you. Congrats on the quarter. Maybe just the first, the underlying environment, you know, this was a pretty significant step up in growth and growth acceleration. Is this all underlying market growth picking up? And if so, what's behind that? And is there a potential of some halo from just, you know, the TSA market and electrophysiology pickup there driving that? And to what extent is this shared gains as well? And that might be booing your growth.

Hi, thank you. Uh, congrats on the quarter.

Um, maybe just the first, uh, the underlying environment. You know, this was a pretty significant step up in growth and growth acceleration.

Is there is this all underlying market growth picking up and if so what's behind that and is there potentially some Halo some some just you know, the PSA Market um and electric physiology pickup, they're driving that and and to what extent is the shared game uh as well. So that might be doing in your growth.

Dan Wilson: Yeah, Rich, thanks for the comments. Look, I think it's a combination of all of it, to be honest with you. There's no question, you know, PFA is having incredible success, and those procedures need to be monitored. And I'm sure we're getting a bit of a benefit from that. I don't think it's the vast majority of it. When you look at PFA, you know, procedures, there's probably 300 to 400,000 being performed. There were, you know, ablations being monitored prior to PFA being introduced as well. So there's probably some benefit, but it's hard for us to measure that specifically, to be honest with you. We don't always know when our monitor is being used post-PFA procedure or not. But I'm sure there's some contribution to it, and we'll continue to enjoy that benefit. And we want to be there to monitor those patients.

Yeah, Rich. Thanks. Uh thanks for the comments. Um,

Dan Wilson: I do think our market share position continues to improve, even in the long-term cardiac monitoring market. You know, we have north of a 70% market share. Our latest data would tell us it's probably close to 72%, which is, you know, an increase from where it was at coming into the year. So I do think we continue to take share. But importantly, I do think the overall market continues to expand. We have made a very concerted effort to push prescribing up the care pathway into primary care. And the reality is more patients are seen at the primary care physician's office, and they're more likely to get a patch in that setting than having to wait till they get referred on to cardiology.

You know, being introduced as well. So, um, there's probably some benefit, but it's hard for us to, to measure that specifically, to be honest with you. We don't always know when our monitors being used post, uh, PFA procedure or not, but that I'm sure there's some contribution to it, and, and we'll continue to enjoy that benefit. And, and we want to be there to monitor those patients. Um, I do think our market share position continues to improve even in long-term. Cardiac monitoring Market. You know, we have north of a 70 percent market. Share. Our latest data would tell you tell us, it's probably close to 702%, which is, you know, an increase from where it was at coming into the year. So I I do think we continue to take share. But importantly, I do think the overall Market continues to expand. We have made a very concerted effort to push. Prescribing up the care pathway into Primary Care.

Dan Wilson: You know, what I love seeing in a lot of these large IDNs that we're working in is that many times now a cardiologist or an EP won't even want to see their patient unless they have a report in hand that's been prescribed, you know, earlier in the care pathway by primary care, and then they show up with it, or they look at the report before the patient ever gets there and makes a determination that they do or don't need to see the patient. That is, that's a terrific sort of way for the product and our tool to be used as it becomes sort of a rule in and a rule out opportunity.

Dan Wilson: And when we look at it down through our business, the amount of prescribing happening in primary care continues to grow in a meaningful way, both in the large IDNs that we're in today, where the cards and the EPs are moving prescribing to primary care, but also then in these innovative channel partners where they are predominantly primary care physician offices. So I think it's a combination of all three that you hit on. I think that it's overall market expansion. I definitely think we're taking, you know, market share in this space, both on the monitor and AT side. And yeah, I think PFA is probably contributing a bit as well.

And the reality is more patients are seen at the primary care, physicians office, and they're more likely to get a patch in that setting than having to wait till they get referred on to Cardiology, you know what I love seeing. And a lot of these large idns that we're working in is that, uh, many times. Now, a cardiologist or an EP won't even, uh, want to see their patient unless they have a report in hand, that's been prescribed, you know, earlier in the care pathway by primary care and then they show up with it. Or they look at the report before the patient ever gets there and makes a determination that they do or don't need to see the, the patient that is um, that. That's a terrific. Sort of way for the product in our tool to be used as it becomes sort of a rule in and a rule out opportunity. And when we look at it down through our business, um, the amount of

Describing happenings in primary care continues to grow in a meaningful way. Both in the large IDNs that we're in today, where the cards and the EPS are moving prescribing to primary care, but also then in these innovative channel partners where they are predominantly primary care physician offices. So, I think it's a combination of all three that you hit on. I think that it's overall market expansion. I definitely think we're taking market share in this space, both on the monitor and at site. And, uh, yeah, I think PFA is probably contributing a bit as well.

Operator: Thank you. Our next question comes from the line of David Rescott with Baird. Please go ahead.

Thank you.

Our next question.

David rat with beard, please go ahead.

Analyst: Oh, great. Thanks for taking the questions, and congrats on a really strong quarter here. I wanted to ask on the new store growth callout that you've been calling out. You know, it's ticked up pretty meaningfully, not only on a quarter-over-quarter basis over the past couple of quarters, but also year-over-year. And at first, I'm just wondering if the innovative channel partners are captured in that new store growth callout. And then, you know, if at all, you know, is it something on the core business, the AT business, these innovative channel partners that are kind of pulling up this same store growth broadly overall?

Analyst: And when you think about these, I guess, the same store, our new store mix going forward, as well as the innovative channel partners, is there any, you know, thing we should be thinking about from a margin contribution perspective in either of those kind of thought processes as it relates to that original, I think, 15% operating margin or rebate down margin that you laid out for the 2027 timeframe? Thank you.

Oh great. Um, thanks for staying the questions and uh, congrats on the really strong quarter here. Um, I wanted to ask on on the new store growth, um, call out that you've been calling out. Um, you know, it it's ticked up pretty meaningfully, not only on a quarter of a quarter basis of the best level, of course, but also, um year over year. And at first, I'm just wondering if the Innovative Channel partners are captured in that new store growth, um, call out. Um, and then, you know, if, if at all, you know, is it, is it something on on the Core Business? The, the at business, these Innovative Channel partners, that are kind of, uh, pulling up this same store growth, broadly overall. And when you think about these, um, the I guess the same store, our new store mix,

Uh, going forward as well as the Innovative uh Channel Partners. Uh, is there any you know thing we should be thinking about from a margin contribution perspective and either of those um kind of thought processes as it relates to to that original, I think 15% operating margin or it rebound margin that you laid out for the 2027 time frame. Thank you.

Dan Wilson: Yep. Thanks for the question, David. This is Dan, and I can address those questions there. So you're right to point out new store growth, you know, ticking up slightly from what we saw in Q1 and really kind of historical patterns. That number does bounce around a little bit. We have been very successful in onboarding new accounts, but not only innovative channel partners, but also within the core business. And we called that out in our prepared remarks. So we've seen a lot of success recently launching large IDN customers, you know, across their entire prescriber base with EHR integration, with ZO Monitor, with ZOAT. So really impressive launches, and that is contributing to that new store growth number as well. And then it's important to point out, you know, overall revenue growth has accelerated as well.

Dan Wilson: So there's still really healthy growth from that same store number if you were to do the math there as well. Your question in terms of margin related to the innovative channel, still very early, but we do believe that can be a very profitable part of our business. We've talked about this one-to-many selling model many times before. We mentioned 1,000 prescribers at Signify turning on, and we're, you know, we're engaging with these accounts really at the top end of these accounts. So we'll see where it goes over time. We're still in the early innings, but I believe it can be a meaningful contributor to the business.

Yep. Thanks for the question, David. This is Dan, I can, um, address those questions there. So, um, you're right to point out new store growth. Uh, you know, taking up slightly from what we saw in q1 and, and really, um, kind of historical patterns that number does bounce around a little bit. Um, we have been very successful in onboarding new accounts but not only Innovative Channel Partners, but also, uh, within the core business. So, we called that out in our prepared remarks. So, um, we've seen a lot of success recently launching large IBN customers, you know, across their entire prescriber base with EHR and integration with Zio monitor with Zio at. Um, so really, really impressive launches and and that is contributing to that new store growth, uh, number as well. And then it's important to point out, you know, overall Revenue growth has accelerated as well. So there's still really Healthy Growth from

From that same store number. Uh, if you were to do the math there as well, um, your question in terms of margin related to the Innovative Channel, um, still very early, uh, but we do believe, um, that can be a very profitable part of our business. We've talked about this 1 to many selling model, uh, many times before we mentioned a thousand prescribers that signify turning on. Um, and we're, you know, we're engaging with these accounts really at the, the top end, um, of, of these accounts. So, um, we'll see where it goes over time. We're still in the early Innings, but I believe it can be a meaningful contributor to the business.

Operator: Thank you. Our next question comes from the line of Suraj Kalia with Oppenheimer. Please go ahead.

Thank you.

Our next question comes from the line of farad Ka with Oppenheimer. Please go ahead.

Analyst: Quentin, Dan, can you hear me all right?

Clinton Dan. Can you hear me? All right.

Dan Wilson: Yep. We got you.

Yep, we got you.

Analyst: All right. Pardon the background noise, Quentin. So I'll be quick. Obviously, a fantastic quarter, Quentin. Maybe you could help us understand. Quentin, you guys are the de facto standard of care on long-term monitoring. For ZOAT in particular, or the MCAT category in particular, I'm curious if you could give us some additional color what all needs to happen because I think so all of us are looking at a straight line to 70% share. You know, but it's not the same as long-term monitoring. Maybe you could help us understand for MCAT, for your velocity of share gains to increase, is it just blocking and tackling? Is it a large IDNs? Is it form factor? Any additional color because that component of the bulk business is obviously picking up pretty rapidly. Any color there would be great. Thank you again, and congrats.

Pardon the background noise gendon, so I'll be quick. Um, obviously a fantastic quarter Clinton, um, maybe you could help us understand.

Quenton, you guys are the defacto standard of Care on long term monitoring.

For Z18 in particular, or the MM Cod category in particular, I'm curious if you could give us some additional color.

What all needs to happen.

Because I think. So, all of us are looking at a, a straight line to 70%, share, you know, but it's not the same as long-term monitoring. Maybe you could help us understand for mcot.

For your velocity of share games to increase. Is this just blocking and tackling is a large, idms? Is it form factor any additional color? Because that that component of the business is obviously picking up pretty rapidly, any colors, that would be great. Thank you again, and for that.

Dan Wilson: Thank you, Suraj. We appreciate that. Look, we are very excited about the MCT category as a whole and our opportunity to continue to take share there. We know that we've got a long way to go to sort of get the parity in terms of market share position relative to long-term cardiac monitoring. I think there's a few things going on there. And as I look back over the last, you know, year and a half or so, I think we've learned a lot about our AT business. You know, you look prior to the warning letter and the 483 observations that we were dealing with, that AT business was growing very healthy for us, 60, 70% every single quarter. And then post that, it really dropped down to, call it, roughly around 20% there for a period of time.

Yeah, thank you sir Roger we appreciate that. Like we're we are very excited about the MCT category as a whole and our opportunity to continue to take share their we we know that, um, we've got a long way to go to sort of get the parity in terms of market share position relative to long-term cardiac monitoring

I think there's a few things going on there and as I look back over the last, you know, year and a half or so, I think we've learned a lot about our at business. Um, you know, you look prior to the warning letter and the, the 483 observations that we were dealing with that at business was growing very healthy for US 60, 70 every single quarter,

Dan Wilson: And yes, there was a competitive disruption that sort of opened the opportunity for customers to begin to look elsewhere. And we certainly took advantage of that opportunity and put our foot in that door with AT. But I think folks are beginning to realize very quickly that the AT product is actually a pretty good product. There's still many shortcomings relative to what the ideal product demands in that space. But when you look at ZOAT and the fact that we monitor for 14 continuous days on a single patch, you're going to get 14 good days of monitoring out of that. And you look at competitive MCT products in the market, even though they're indicated up to 30 days, we know from data that the average wear time for competitive MCT devices is only 12.8 days. They're only wearing two patches generally to get to the 12.8 days.

Dan Wilson: So we do offer a solution that I think is easy to use. Patients like it. Once we get integrated with systems, it's very easy from a workflow perspective to use both ZO Monitor and ZOAT. And that has contributed to our success to date. But I also think that does have some limitation in terms of how far it can go if we ever want to get to the full 70%. And that's why we're excited about ZO MCT, which will get submitted with the FDA this quarter. When we bring that product to market, we're going to have a much longer duration. We're going to be on the same form factor as Monitor. You know, we're going to have the ability to really start to close some of the competitive gaps that have been out there relative to other products that ZOAT just hasn't had.

And then post that it really dropped down to to call it roughly around 20% there for a period of time. And and yes there was a competitive disruption that sort of opened the opportunity for customers to begin to to look elsewhere. And we certainly took advantage of that opportunity and and put our foot in that door with at. But I think I think folks are beginning to realize very quickly that the at product is is actually a pretty good product. There's still many shortcomings relative to what the ideal product demands in that space. But when you look at zoat and the fact that we monitor for 14, continuous days on a single patch, you're going to get 14 good days of monitoring out of that. And you look at competitive MCT products in the market even though they're they're indicated up to 30 days. We know from data that the average wear time for competitive MCT devices is only 12.8 days. They're only wearing 2 patches generally to get to the the 12.8 days.

So we do offer a solution that I think is easy to use patients, like it once we get integrated with systems, it's very easy from a workflow perspective to use Bozo Monitor and zoat. And that is contributed to our success to date.

Dan Wilson: And I do like that opportunity to continue to close that gap. But I also think as we learn more about the AT or, sorry, the MCT market, there's probably two markets within MCT. There's what we call sort of the buy and bill market where, you know, customer accounts are buying the device directly from a competitor of ours. They put it in their clinic. They're doing the interpretation, the reading right there in clinic, downloading the data. We don't offer that sort of business model. And ZO MCT is something that we're going to have to continue to evaluate how we address that segment of the market. I think that's probably 20% or so of the entire MCT market that we're still probably going to have to think through the right product market fit for how we get after that segment of the market.

But I also think that does have some limitation in terms of how far it can go. If we ever want to get to the full 70%, and that's why we're excited about Zoom CT, which will get submitted with the FDA this quarter. Um, when we bring that product to Market, we're going to have a much longer duration. We're going to be on the same form factor as monitor. Um, you know, we're we're going to have the ability to really start to close some of the competitive gaps that have been out there relative to to other products that zoat just hasn't had. And and I do like that opportunity to continue to close that Gap.

Dan Wilson: But there's still 80% of that MCT market that our MCT product, new MCT product, is going to go squarely at and I think going to have tremendous success within it. So a lot that we're still learning there, very bullish on the MCT market overall, and clearly incredibly thrilled with the success that the team is having in driving the AT product in that business opportunity today.

But I also think as we learn more about the at or sorry the MCT Market, there's probably 2 markets within MCT. There's what we call sort of the buy and and build Market where uh, you know, customer accounts are buying the device directly from a, a, a competitor of ours, they put it in their Clinic. They're doing the interpretation, the, the reading right there in clinic downloading the data, we don't offer that sort of business model, um, and zoom, CT is something that we're going to have to continue to evaluate how we address that segment of the market. I think that's probably 20% or so of the entire MCT Market, um, that we're still probably going to have to think through the right product Market, fit for how we get after that segment of the market. But there's still 80% of that MCT Market, that that are MCT.

Our new MCT product is squarely aimed at the night segment, and we believe it will have tremendous success within it. There’s a lot that we’re still learning, but we are very bullish on the MCT market overall. We are clearly incredibly thrilled with the success that the team is having in driving this product within that business opportunity today.

Operator: Thank you. Our next question comes from a line of William Kovanic with Canaccord Genuity. Please go ahead.

Thank you.

Our next question comes from the line of William Kevon with Kord genuity

Please go ahead.

Analyst: Great. Thanks. Good evening. Thanks for taking my questions. You know, it's a good quarter. Everybody's asked a lot of the great questions. I'd really like to focus on the FDA. It looks like it's in the rearview mirror. I just want to clarify at this point, you know, you've answered, you know, where are we in the process? It sounds like you've answered all the questions and you're just waiting for that final inspection in terms of the 483 and the warning letters. I want to be clear on that, if you know, kind of what's left there. And then secondly, given the commentary that the ZO MCT is going to file this quarter, I assume that that means they're running in parallel, not sequentially in terms of kind of wrapping one up before you go for the next. Thanks.

Great, thanks. Good evening. Thanks for taking my question. Um,

Your son, the FDA. It looks like it's in the rearview mirror. I just want to clarify at this point, you know, you've answered, you know, where are we in the process? It sounds like you've answered all the questions and you're just waiting for that final inspection in terms of the 483 in the morning letters. I want to be clear on that if you know kind of what's left there. And then secondly given the commentary that the zlm CT is going to file this quarter. Um I assume that that means they're running in parallel, not sequentially in terms of kind of wrapping 1 up before you go for the next thanks.

Dan Wilson: Yeah, let me hit that last one, Bill, first on the MCT filing running in parallel. I presume you mean in parallel with sort of remediation or the FDA coming back to close down the warning letter. And if that is what you're referring to, you're absolutely right. They will run in parallel. There's nothing that's holding up our MCT submission and the FDA reviewing that. So that will get on file here in the third quarter. And yes, it will run in parallel. With respect to the FDA, I think it's important to note I don't ever view it as it being in the rearview mirror. I think this is a new way of doing business for us. We have revamped our quality management system. We're doing things in a very different way than what we had historically. And that's the new way of doing business for iRhythm.

Yeah, let me hit that last 1. Uh, bill, first on on the MCT filing running in parallel.

I I I presume you mean in parallel with sort of remediation or the FDA coming back to close down the the warning letter and if that is what you're referring to, you're absolutely right. They will run in parallel, there's nothing that's holding up our MCT submission and and the FDA reviewing that so that will get on file uh here in the third quarter and and yes it will run in parallel with respect to the FDA. I I think it's important to Note. I

Dan Wilson: And we've embraced that. And I think it ultimately becomes a competitive differentiator as we think about sort of how these IDTFs get utilized in this marketplace. I think our team has done a phenomenal job of addressing the concerns that were identified in the warning letter and the 483 observations. To your point, we have submitted all of our responses to them, and now we're waiting for them to respond to us up to and including an inspection to close out the warning letter. So everything we've committed to that had dates tied to it, obligations tied to it, we have completed that, and we have handed that back over to the hands of the FDA. Now, keep in mind, we obligated ourselves to go above and beyond what the FDA was focused on.

I don't ever view it as it being in the rearview mirror. I think this is a new way of doing business for us. Um, we have revamped our quality management system. We're doing things in a very different way than what we had historically and that's the new way of of doing business for ithm and uh We've embraced that and I think It ultimately becomes a competitive differentiator as we think about sort of how these idtf get utilized in.

This Marketplace. I think our team has done a phenomenal job of addressing the concerns that were identified in the warning letter in the 43 observations to your point. We have submitted all of our responses uh to them. And and now we're waiting for them to respond to us up to an including uh an inspection to close out the warning letter. So everything we've committed to uh

Dan Wilson: We took a holistic view of the entire quality management system and said, "We're going to revamp the entire thing as we get after this." There's still some work that we're doing there that went above and beyond what the FDA had focused on that will be completed in the back part of this year. Once that is completed, that is when we'll have the third-party firm come in and audit us just as if they were the FDA. And frankly, probably with more of a scrutinizing eye than even the FDA would. And we've told the FDA we'll share the outcome of those results once they're through it. So I feel really good about the progress we've made here. The tone, the communication, it's a 180 from what it was, you know, two years ago.

that had dates tied to it obligations tied to it. We have completed that and we have handed that back over to the hands of the FDA now. Keep in mind, we obligated ourselves to go above and beyond what the FDA was focused on. We we took a holistic view of the entire quality management system. And said we're going to revamp the entire thing as we get after this. There's still some work that we're doing there that went above and beyond what the FDA had focused on that. Will be completed in the back part of this year. Once that is completed, that is when we'll have the third party, uh, firm come in and audit us. Uh, just as if they were the FDA and frankly probably with more of a scrutinizing eye than even the FDA would and and we've told the FDA, we'll share the outcome of those results. Uh, once they're through it. So

Dan Wilson: I do think as we continue to innovate in this space at the pace that we want to, we're always going to be working very closely with the FDA. And that needs to be a very collaborative relationship. And that's what's been established now. And I'm really pleased with how the teams have handled that and the relationships they've been able to build. So I hope that answers your question. We're excited about the future. We still have a little bit of work here to do to close out the formal warning letter, which includes them coming on site. I can't tell you when that's going to happen, but we're ready for them when they're ready to be here.

I feel really good about the progress. We've made here the tone, the communication, uh, it's a 180 from what it was, you know, 2 years ago. Um, I do think as we continue to innovate in this space at the pace that we want to, we're always going to be working very closely with the FDA uh and that needs to be a very collaborative relationship and that's what's been established now. And and I'm really pleased with um, how the teams have handled that and and the relationships, they've been able to build so um,

I hope that answers your question. We're we're excited about the future. We still have a little bit of work here to do that. To close out, the formal warning letter, which includes them coming on site. I can't tell you when that's going to happen, but, uh, we're ready for them when when they're ready to to be here.

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

Thank you.

There are no additional questions waiting at this time, I would like to pass the conference back to the management team for any closing remarks.

Dan Wilson: Well, thank you. Thank you for your time today, and thank you to our outstanding iRhythm team. You know, it's hard to imagine a time when we've been more optimistic about the future that sits ahead of us. The market opportunity is substantial, our competitive position is strengthening, and our execution continues to deliver. We look forward to continuing to execute against our strategic plan and unlock the tremendous potential that sits before us. Thanks again for your time today, and we'll see you all soon on the road.

Well thank you. Uh thank you for your time today and thank you to our outstanding, I Rhythm team. You know it's hard to imagine a time when we've been more optimistic about the future that sits ahead of us the market opportunity is substantial. Our competitive position is strengthening and our execution continues to deliver. We look forward to continuing to execute our against our strategic plan and unlock the tremendous potential. That sits before us, thanks again, for your time today. And we'll see you all soon on the road.

Operator: That concludes the iRhythm Technologies Inc. Q2 2025 earnings conference call. I hope you all enjoy the rest of your day. You may now disconnect your lines.

That concludes the eye Rhythm Technologies, Inc, Q2 2025 earnings conference call? I hope you all. Enjoy the rest of your day. You may now disconnect your lines.