iRhythm Holdings, Inc.

I've remarked there'll be an opportunity to ask questions. If you'd like to ask a question during this time, you can do so by pressing star followed by one on your telephone keypad. I'll now hand you over to Stephanie Zadkiewicz, Director of Investor Relations, to begin. Please go ahead when you're ready.

Thank you all for participating in today's call. Earlier today, iRhythm released financial results for the second quarter ended June 30th, 2024. 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 law pursuant to the safe harbor provisions of the Private Security 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 four looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our most recent annual and quarterly reports on Form 10-K and Form 10-Q, respectively, filed with the Securities and Exchange Commission. Also during the call, we will discuss certain financial measures that have not been prepared in accordance with U.S. GAAP with respect to our non-GAAP and cash-based results, including adjusted EBITDA, adjusted operating expenses, and adjusted net loss. Unless otherwise noted, all references to financial metrics are presented on a non-GAAP basis. The presentation of this additional information should not be considered in isolation of, as a substitute for, or superior to results prepared in accordance with GAAP. Please refer to the tables in our earnings release and 10Q for reconciliation of these measures to their most directly comparable GAAP financial measures. 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, August 1st, 2024. iRhythm displays 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 will turn the call over to Quinton Blackford, iRhythm's President and CEO.

Thank you, Stephanie. Good afternoon, and thank you all for joining us. Bryce Bobzien, our Chief Financial Officer, and Dan Wilson, our EVP of Corporate Development and Investor Relations, join me on today's call. My prepared remarks today cover business updates during the second quarter of 2024, as well as our annual outlook. I'll then turn the call over to Bryce to provide a detailed review of our second quarter financial results and updated 2024 guidance. Finally, Bryce and Dan will both discuss the CFO transition that we announced earlier today before I close out with final remarks. Once again, we realized strong results in the second quarter from our core business as we achieved revenue of $148 million, representing 19.3% growth versus the prior year. This success was driven by another quarter of record volume demand, along with a slight improvement in average selling prices. Within our core business, our teams continue to drive growth from new accounts that were opened in the prior 12 months, as well as penetration in existing accounts. And we have built a very strong pipeline thanks to the growing recognition of Zio's value proposition. The compelling Camelot real-world evidence data demonstrating Zio superiority, both across categories and within category directly against competitors for highest diagnostic yield and lowest retest rate, continues to provide traction with clinicians and health systems. Payers have also responded favorably to our health economic data in Camelot, enabling our market access team to drive favorable negotiations with greenfield contracts and to drive updates to several existing coverage policies for improved patient access. Our continued focus within the primary care channel has been successfully driving conversions from competitors as well as continued conversion of customers from traditional modalities such as short-term Holter monitoring with a steady stream of new evidence demonstrating the value of 14 days of monitoring for a range of arrhythmias not only AFib. In addition to winning competitive share and driving the mixed shift towards long-term continuous monitoring, iRhythm is driving accelerated expansion of the total ACM market by expanding into primary care, where we estimate that there are more than 15 million patients with cardiac-related palpitations who visit their physicians each year. Zio's value proposition to address the quintuple aim of healthcare is clearly resonating with primary care providers and integrated delivery networks, as well as large national primary care accounts, some of whom have begun to proactively monitor for arrhythmias, even if a patient is not symptomatic. In large IDNs, cardiologists, EPs, and primary care physicians have begun to appreciate the utility of Xeo as a workflow efficiency tool, enabling them to diagnose the right patient the first time and alleviate some of the capacity constraints facing many cardiologists and EP practices by helping to identify the appropriate patients who should be seen by these specialty physicians. We believe that this trend towards pushing zeo earlier in the treatment care pathway will only accelerate with further appreciation the zeo value proposition by primary care providers. And with initiatives such as our epic aura ehr partnership, which will be introduced into the first accounts in the fourth quarter of this year and then launch a more broadly in 2025. Additionally, we have found solid traction and product market fit in the undiagnosed arrhythmia space, specifically in value based primary care programs. which has been the culmination of several factors we have been driving over the past few years. The known increases in healthcare utilization and cost have been met with a focus on serving patients in lower cost settings of care. The ease of use for physicians and patients alike of our XeoMonitor, together with iRhythm's clinical evidence with mSTOPs and other trials, demonstrate Xeo's ability to identify undiagnosed arrhythmias and the cost effectiveness of a proactive arrhythmia monitoring approach. In parallel, the Camelot data showed that long-term continuous monitoring is associated with the lowest healthcare utilization, with Xeo specifically having the highest diagnostic yield and lowest retest rates compared to competitors. What we initially conceived as our know-your-rhythm program for the payer channels has been instead organically adopted by innovative value-based care organizations over the past few quarters to encapsulate proactive monitoring strategies. We've been excited by the early progress in this area as we've seen some of our top customer accounts during the second quarter prescribing Zio for proactive monitoring. Even more encouraging is that we signed a number of additional large national accounts during the second quarter with a strong pipeline that remains in place that we believe will be nice contributors of future growth. Turning to ZOAT, we continued to make progress on the remediation activities of the FDA warning letter during the quarter and submitted the first of our responses to the FDA on the two 510 s this week with the second plan to be submitted shortly. Recall that we submitted two 510 files in January of this year. One is a catch up for changes previously made to the ZOAT system as a letter to file and a second 510 for design features and labeling updates to further address areas of focus noted in the FDA warning letter. The agency came back with a request for data that included incremental electromagnetic compatibility or EMC testing and human factors testing around design changes made to satisfy their request. We look forward to having provided these responses in the near term and will then wait to hear back from the FDA. With respect to the FDA, the agency was on site at our San Francisco and Orange County facilities in the back half of July. The inspections concluded yesterday with several 483 observations noted. We are in the early stages of evaluating these and we intend to provide responses to the FDA in a timely fashion. At a high level, the observations were primarily focused on our quality system and regulatory compliance, including complaint handling and medical device reporting, risk analysis regarding the involvement of the company's certified technicians to prepare the ECG reports and the CAPA process. We remain committed to our customers' patient safety, quality, and compliance, and we will continue to work diligently and collaboratively to resolve the warning letter to the FDA's satisfaction. In parallel, our teams continue to work diligently to prepare for the subsequent filing of our next generation MCT product, ZOMCT, and we continue to believe that 510 submission for that product will be submitted late in the second half of 2024 following clearance of the two 510Ks for ZOAT. Moving to our strategic pillars for future growth, we are also making significant strides to open up new opportunities outside of our core business beginning in the back part of this year. In Western Europe, we remain on track to launch commercial activities in four countries, the Netherlands, Austria, Switzerland, and Spain, with first patient patching anticipated before year-end 2024. we could not be more excited for the culmination of this enormous cross-functional effort that demonstrates iRhythm's commitment to introducing a better way to monitor for arrhythmias to millions more patients globally. As we move into 2025 and beyond, commercial launch in these countries could constitute an incremental market opportunity of 1.5 million patients who could potentially benefit from Xeo each year. It also represents an important lever for growth towards our $1 billion revenue target in our 2027 long-range plan. To support this broad commercial launch, we have completed two limited market evaluations in five top centers in Switzerland and Spain, continue to be very active at major European medical conferences with educational events and presentations, and have held an advisory board with 15 of Europe's leading KOLs to drive physician awareness of Zio. In Japan, we continue to anticipate a regulatory decision by the PMDA in late 2024. representing the first step of our foray into the second largest medical device market in the world with approximately 1.6 million ACM tests being prescribed per year. Recall that we received a high medical needs designation from the Japanese MHLW last year and that this distinction is specific to Xeo. Granted at the recommendation of the Japanese Heart Rhythm Society, this designation has created significant interest with potential commercial partners and also has informed our regulatory submission with the PMDA. As we continue to engage with the Japanese PMDA, we have finalized our reimbursement dossier that would be submitted to the MHLW immediately following a regulatory decision. We are also pleased to note that we have now signed a letter of intent with our distribution partner in Japan. We are actively collaborating with them to prepare for a limited market launch in the first half of 2025 and look forward to sharing more details as we make progress in the coming months. In potential new indications, we plan to move forward with a market evaluation in obstructive sleep apnea in the United States in 2025, representing our initial foray into an adjacent indication with significant overlap in arrhythmias and a sizable unaddressed patient population. Thus far, early results from the sleep pilot that we launched in February have indicated that physician demand is high for a service that could streamline their workflow to decrease current pain points in the diagnostic journey for OSA, including insurance validation, patient facilitation, and comprehensive report delivery, all in an integrated digital platform. Market research performed to date associated with this project has confirmed that cardiologists are likely to be early adopters of a service that combines an OSA and ACM diagnostic. A frictionless ordering process, high-quality report with clear insights, and seamless integration between the two tests were cited as key features physicians would look for in this type of service. These learnings have validated our views of the value of a technology and service platform that can serve multiple patient indications. We plan to continue building a potential product and service offering that we can then launch into market evaluation beginning in 2025. With that, I'll now turn the call over to Bryce to discuss our recent financial performance.