iRhythm Holdings, Inc.

You may proceed. Thank you all for participating in today's call. Earlier today, iRhythm released financial results for the fourth quarter and full year ended December 31st, 2023. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. These are based upon our current estimates and various assumptions and reflect management's intentions, beliefs, and expectations about future events, strategies, competition, products, operating plans, and performance. These statements 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. 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 report 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 10-K for a reconciliation of these measures to their most directly comparable GAAP financial measures. Unless otherwise noted, 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, February 22, 2024. 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 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 fourth quarter of 2023, as well as a 2024 outlook and initiatives. I'll then turn the call over to Bryce to provide a detailed review of our fourth quarter financial results and 2024 guidance. You heard from us in January that 2023 was a transformational year for iRhythm on multiple fronts. We drove a banner year, re-accelerating our unit volume growth with a record number of new accounts, advanced our penetration into the primary care channel, introduced groundbreaking clinical evidence of superiority, continued market access traction, and opened our global business services center in the Philippines, all while introducing greater operational discipline across the organization and launching the most successful product in the history of our company in the XeoMonitor. This fueled our performance in the fourth quarter that led to full-year revenue of $493 million, or growth of 20% versus the prior year, in line with our long-range plan, exceeding the high end of our guidance range, and reflecting momentum across multiple channels. In the fourth quarter, we continued building upon the solid execution of the first nine months of 2023. We were pleased to see strong volume contributions from both new and existing accounts exiting the year. While nearly 70% of registration growth came from existing accounts, The fourth quarter was the second strongest quarter of new account openings in our history, setting up nicely as we move into 2024. The ease of use, accuracy, and simple workflow of Xeo Monitor and Xeo Suite digital products is resonating within the primary care channel. which represented approximately 21% of total U.S. ZOXT registrations during 2023, a figure that has grown consistently over the past few years and was driven by innovative PCP network account activations as well as continued emphasis on our land and expand strategy within integrated health networks. ZO Monitor, which launched last September, has also progressed faster than planned, now representing nearly 70% of registrations for our long-term continuous monitoring services. We believe the combination of the Xeo Monitor form factor with its smaller profile and high rate of patient compliance, as well as our refreshed myXeo app, has continued to contribute to an improved device return rate of approximately half a percent thus far in our product launch cycle. While in the early stages, Xeo Monitor has also improved the patient journey, resulting in fewer calls into our customer care teams from patients. In addition, we have seen that patients who are digitally engaged via the MyXeo app have a much higher compliance rate, especially for home enrollment patients. As we continue to transition all in-clinic accounts to Xeo Monitor throughout the first half of 2024, we are excited to see how the largest launch in the history of our company could catalyze additional momentum in the business. To further improve clinician workflow efficiencies, to streamline access to Xeo services, and to enable healthcare provider access to patients' electronic health information, we also remain committed to investments in the service aspects of our systems, such as electronic health record integration offerings. During 2023, we implemented new bi-directional EHR integrations across nearly 950 customer locations and have now received more than 1.5 million all-time registrations for Xeo services through EHR integrated accounts. EHR integrations are intended to allow for an administratively simpler process and integrate Xeo into existing workflows of our customers and their staff. By embedding the Xeo experience into the native EHR platform of a health system or practice, these integrations allow streamlined access for ordering, document review, and billing, thereby enabling our customers and their staff to spend more time with patients throughout the care pathway. Moreover, we know from experience that EHR integration accelerates same-store growth, such as making Xeo directly available to primary care and non-cardiology specialists. The operational efficiencies we can drive for our customers is a clear differentiator as we expect to have more exciting announcements on this front as we move through 2024 and beyond. In our Xeo AT business, we continue to work diligently and collaboratively with the FDA to remediate concerns noted in their warning letter to us last year. We have now submitted two 510 applications. One is a catch-up for changes previously made as letter to file to the ZOAT system before our receipt of the warning letter, and a second 510 to capture changes to design features and labeling updates following our interaction with the FDA. While we believe that our next-generation ZOMCT device will further strengthen our competitive positioning in this space, we still believe that there are meaningful market share gains to be made with our ZOAT product compared to the approximate 7% penetration that we currently hold in the mobile cardiac telemetry category. In the MCT category, we estimate that every 10 points of share gain represents roughly $80 million to $100 million of incremental revenue to iRhythm, a significant opportunity for growth as we aim to deliver on our $1 billion revenue target in our long-range plan. As we continue to progress our product innovation roadmap, we have also continued to build upon our substantial body of clinical evidence with strong fourth-quarter publication output in top-tier medical journals and at conferences. The INSTOP's cost-effectiveness data was published in November 2023 and demonstrated that proactive monitoring for atrial fibrillation in an at-risk population with the iRhythm ZOXT patch provided high value from a health economic perspective. The CAMELOT study, which has been part of our commercial narrative for much of 2023, was published in the American Heart Journal in December. The manuscript, with independent statistical analysis, extends the initial findings in several ways. One, shows Xeo's long-term cardiac monitor superiority for highest odds of arrhythmia encounter diagnosis and lowest odds of retesting not only across different categories of monitoring, such as Holter and event recorders, but directly against specific competitor products and services. And two, it showcases Xeo's long-term cardiac monitor performance and clinical superiority for specific critical arrhythmias, such as heart block and ventricular tachycardia, which can have major clinical consequences if missed. This peer-reviewed publication continues the long history of evidence that the Xeo long-term continuous monitoring service provides high value and performance with the highest diagnostic yield and lowest likelihood of retesting across a wide range of ambulatory cardiac monitoring services. We also continue to make strides in AI. A December publication in Nature Digital Medicine by the Scripps Research Translational Institute in collaboration with our team demonstrated the performance of developed AI to identify patients at risk of near-term AFib based on patients who had no AFib on their initial ZO patch. This early work could help identify which patients should have repeat testing. Additionally, research from our collaboration with the Duke Clinical Research Institute presented at November's American Heart Association meeting, demonstrated the ability to more robustly predict heart failure hospitalization when adding ZOECG features to existing clinical risk models. Both studies advance our thesis that 14 days of continuous, uninterrupted ZO monitoring has valuable biometric information that can classify and predict conditions or risks well beyond the arrhythmias we diagnose with ECG monitoring today. These insights demonstrate feasibility of adjacent market opportunities and validate our ability to provide novel insights through our platform for future value creation. These are also being proven from a business model perspective by our teams. We were excited to see our first Know Your Rhythm pilot launch this quarter aimed at identifying arrhythmias in asymptomatic populations, and while early, we are seeing very encouraging data supportive of the value propositions. Similarly, we are seeing several national primary care networks employing proactive screening approaches with targeted populations aimed at finding arrhythmias sooner and avoiding the devastating downstream cost of care that come from patients unaware of existing arrhythmias. iRhythm is uniquely well-positioned to address the macro shift in healthcare towards value-based care for an aging population as cardiac monitoring with Xeo adds value to all five objectives of the quintuple aim of healthcare. We look forward to sharing more details on these initiatives as they progress. We also expect to be launching our very first pilot into the sleep space in the coming months. With deep relationships with cardiologists, electrophysiologists, and primary care physicians, as well as our experience with remote diagnostic services, iRhythm is well positioned to validate our belief that there is a need for a streamlined diagnostic pathway into what we have heard can feel like a fragmented and disjointed sleep diagnostic journey for both patients and clinicians. Today, the process of referring a patient to a sleep specialist, prescribing a sleep lab or a home sleep test, all the way through to a formal diagnosis can be a cumbersome experience. Our initial pilot will be aimed at exploring the value of a process from the ordering of a sleep test to the delivery of the interpreted results and diagnostic report to the prescribing physician via a streamlined integration with a single portal, such as our XeoSuite platform. We see sleep as an important adjacent market and have multiple initiatives in place to explore how we can bring our innovative capabilities into this space for the benefit of clinicians and patients. Turning towards our international efforts, we were thrilled to have received CE Mark under European Union Medical Device Regulation, or EUMDR, for XeoMonitor and the Zeus system at the end of 2023. This marks the jumping-off point to introduce our innovative technology into more European markets and enable further global expansion. Importantly, the EU MDR is arguably one of the most stringent regulatory frameworks for product approvals globally, and receipt of this certification demonstrates our commitment to providing the highest quality products and services. With CE Mark in hand, we are continuing market access evaluation and market expansion efforts in prioritized countries across Europe, including four countries targeted for entry in 2024 where there are approximately 800,000 ambulatory cardiac monitoring tests performed annually. In preparation for these launches, our market access teams have been hard at work with various countries on our roadmap, and encouragingly, Switzerland has just released an updated national reimbursement decision for long-term ECG examinations in excess of 1,000 Swiss francs. We have also continued to pursue national reimbursement in the UK. As we continue to progress with the public health systems while we await a decision on national reimbursement by the National Health System, we continue to advance our efforts within the UK private payer sector that demonstrated significant growth in 2023. Through the Artificial Intelligence and Health and Care Award from the NHS England in September 2020, real-world evaluation of ZOXT at scale across NHS Trust has shown that ZO service has an overwhelmingly positive impact on patient waiting times, hospital resource utilization, clinical diagnostic yield, and pathway cost savings. We will continue to work through contracting at private UK sites where this message is clearly resonating. In Japan, we continue to be excited about the upcoming entry into the second largest cardiac monitoring market in the world with approximately 1.5 million ACM tests being prescribed per year. Recall that we received a high medical needs designation from the Japanese MHLW last year and it is important to note that this designation is not specific to long-term patching, but is instead specific to Xeo. This designation, at the recommendation of the Japanese Heart Rhythm Society, has created significant interest with potential commercial partners, and we are pleased that, after thorough search, we have identified our distribution partner for Xeo in Japan. We are actively collaborating with them to prepare for the launch in early 2025 while we continue to engage with the Japanese PMDA on a regulatory dossier in parallel. Lastly, but very importantly, we are committed to continue driving operational efficiency and financial sustainability through an intense focus on organizational discipline as we work towards achieving our adjusted EBITDA targets stated in our long-range plan. While there is still work to do to achieve the 15% adjusted EBITDA margin goal we set for ourselves for 2027, I have been pleased by our ability to drive 1,000 basis points of improvement over the past two years. The performance of the newly minted Global Business Services Center in Manila has exceeded our expectations thus far, and the process excellence this group has driven will be a key enabler for the global growth towards which we are striving in the years to come. Additionally, within the first half of 2024, we anticipate implementing automation in our production lines for XeoMonitor that will drive scale, reduce our cost to manufacture, and serve as the basis for our next generation ZOMCT platform. We are excited about these initiatives and others that continue to create leverage throughout our P&L, and we are energized to drive programs that will allow us to serve more patients more efficiently around the globe. With that, I'll now turn the call over to Bryce to discuss our recent financial performance.

Thanks, 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. Fourth quarter 2023 results demonstrated continued strength in our core markets as revenue grew to $132.5 million, representing 6% sequential and 18% year-over-year growth. As Quentin mentioned, this was driven by strong volumes from new accounts opened in the prior 12 months, continued penetration of existing accounts, and reduced account churn. New store, same store mix, with new store defined as accounts have been open for less than 12 months, accounted for approximately 34% of our year-over-year volume growth. Home enrollment for Xeo Services was approximately 21% of volume in the fourth quarter. Average selling prices during the fourth quarter were down approximately 400 basis points year-over-year and down slightly quarter-over-quarter. Moving down the rest of the P&L, gross margin for the fourth quarter was 66%, and for the full year 2023 was 67.3%. As previously discussed, we expected temporary gross margin pressure in the back half of 2023, primarily driven by costs associated with the transition from ZOXT to the new ZO Monitor. We continue to see positive marketplace reaction to ZO Monitor. This has resulted in a faster than anticipated transition from ZOXT and has created near-term pressure on the gross margin due to the accelerated recognition of costs of our legacy XT components. This accelerated transition does not yet have the benefit of automation and scale, which resulted in an increased cost per unit. We believe that this will be mitigated once automation lines for XeoMonitor are implemented Finally, we completed the current phase of building our center of excellence in our San Francisco IDTF in the fourth quarter. We've incurred costs related to scaling and training newly onboarded clinical cardiac technicians that resulted in inefficiencies in the short term. These investments were important to ensure the quality of our services provided to our patients, and we expect the associated cost to abate as the team come up to speed over the next couple quarters. Fourth quarter adjusted operating expenses were $113.8 million, up 6.2% sequentially, and 17.2% year-over-year. Full-year adjusted operating expenses were $430 million, up 18.2% compared to 2022. Sequentially, the increased spend was driven by legal, regulatory, and professional fees. Compared to the fourth quarter 2022, this increase in adjusted operating expenses was primarily due to increased personnel to scale operations, as well as the previously mentioned professional fees. During 2023, we incurred approximately $9 million of legal and consulting fees, as well as other company expenses related to the FDA warning letter and DOJ subpoena. Despite these temporary expenses and rolling out the most significant product launching in the company's history, we were able to drive 120 basis point improvement in adjusted operating expenses as a percentage of revenue. Adjusted net loss in the fourth quarter was approximately $25.8 million, or a loss of $0.84 per share. compared to an adjusted net loss of 17.9 million, or an adjusted net loss of 59 cents per share in the fourth quarter of 2022. Adjusted net loss for the full year 2023 was approximately 96.5 million, or $3.16 per share, compared to an adjusted net loss of 84.5 million, or a loss of $2.82 per share during 2022. Fourth quarter 2023 business transformation costs were 1.8 million, bringing full year 2023 business transformation costs to 15.9 million. in line with guidance as we finalize the transition to our Global Business Services Center. Additionally, we recorded an impairment charge of $11.1 million related to the capitalized value of our San Francisco office as a result of the continued declining commercial real estate market conditions within San Francisco. Adjusted EBIT in the fourth quarter 2023 was $2.4 million, reflecting an increase of $2 million sequentially and an increase of $1.3 million year-over-year. Adjusted EBIT for the full year 2023 was minus $4.9 million, representing 180 basis point improvement to adjusted EBIT margin compared to 2022. Absent the expenses related to legal and advisory fees, as well as other company expenses associated with the FDA warning letter and DOJ subpoena, adjusted EBIT margin would have been approximately 0.8%. Turning to guidance, we are reiterating our 2024 outlook as presented earlier this year and anticipate full-year revenue of approximately $575 to $585 million, driven predominantly by volume growth in our core markets. As we think about the first quarter, we did see weather-related impacts in January. However, we've seen registrations rebound nicely thus far in February. We believe that the first quarter revenue trend will be closer to 22% of full-year revenues, considering weather-related impacts from January of approximately $1 to $2 million. Excluding this, we would have expected to see first quarter 2024 in line with historical averages at approximately 22.5%. Turning to gross margin, we are providing full year 2024 gross margin guidance in the range of 68 to 69%, an improvement of approximately 120 basis points at midpoint. During the first half of 2024, we anticipate continued direct and indirect costs from the transition to XeoMonitor, natural inefficiencies from the implementation of automation to produce XeoMonitor at scale, and the optimization of our Center of Excellence in San Francisco. We expect the first half to be relatively consistent with the 2023 gross margin exit rate. In the back half of the year, however, we anticipate an improvement in gross margin due to the majority of our business being transitioned to the new XeoMonitor platform, initial ramp of automation lines to produce XeoMonitor, and our clinical operations team in San Francisco operating at full capacity. For 2024, we anticipate adjusted EBITDA margin to range between 3% and 4% of revenues, which would represent a 400 to 500 basis point improvement compared to 2023, in line with our slated path to adjusted EBITDA targets in 2027 and driven by our focus on sustainable operating leverage improvements throughout the P&L. As a reminder, adjusted EBITDA will continue to exclude impairment and restructuring costs, business transformation costs, and stock-based compensation expenses. We have contemplated in our adjusted EBITDA guidance approximately $8 to $10 million of legal, consulting, and other company expenses in 2024 as we continue to remediate findings associated with the FDA warning letter and navigate responses to the DOJ subpoena. As we make progress on these two issues, the vast majority of these costs will come out of the P&L in the future. Finally, we ended 2023 in a strong financial position with approximately $133.8 million of cash in short-term investments. As you're aware, we improved our capital position at the beginning of 2024 with the introduction of financing with Braidwell to mature our capital structure ahead of our next phase of growth. As a reminder, your end cash and short-term investments balance does not include the repayment of $35 million to Silicon Valley Bank or the $75 million term loan drawn down from Braidwell at the beginning of 2024. As we continue to grow and mature, we will evaluate our capital structure to ensure financial flexibility in alignment with shareholder interests. With that, I'd like to turn it back to Quinton before we open it up for questions.