Quentin Blackford
Analyst · Morgan Stanley
Thank you, Stephanie and good afternoon, and thank you all for joining us. Doug Devine, our Chief Operating Officer and Chief Financial Officer; and Dan Wilson, our EVP of Corporate Strategy and Development, join me on today's call. My prepared remarks today cover progress we've made throughout the first half of 2022 and discuss the near and long-term growth initiatives for our business. I'll then turn the call over to Doug to provide a detailed review of our second quarter financial results. Starting with our second quarter results, we were pleased with the performance during the quarter with revenues up 10% sequentially and 26% year-over-year, and we achieved record quarterly registrations amidst a difficult market environment. Our top line results were ahead of expectations and position us well for the second half of 2022 and beyond. We also continue to make progress in driving an increased focus on operational discipline, delivering nearly 200 basis points of sequential improvement in our gross margin profile. In our core U.S. commercial business, we achieved another record of quarterly registrations driven by an all-time high number of new accounts doing business with us in the quarter with new account openings in the second quarter, up 22% compared to the first quarter of 2022. Our volume performance outperformed the market year-to-date, driven by our strong growth in primary care and other specialty segments as we continue to grow our overall share of the market. While we realized our highest level of daily registrations ever in the month of June, we have already seen seasonality typical of the summer months, and there continues to be clinical staffing shortages and a challenging macroeconomic environment, which we anticipate will continue through the back half of the year. On the pricing front, we shared last month that CMS published the proposed calendar year 2023 Physician Fee Schedule, which contained proposed payment rates for the two main CPT codes related to long-term continuous ECG monitoring. In the proposed rule, CMS published data that implies payment rates ranging from $207 to $295 across the Company's three IDTFs. We estimate that proposed rates will have an immaterial impact on our overall ASP in calendar year 2023 versus calendar year 2022. We are now in a public comment period that runs through early September before CMS issues a final rule anticipated in early November for implementation on January 1, 2023. During the open comment period, we are continuing to fully participate in the rule-making process to share relevant information as CMS finalizes their rates for calendar year 2023. Turning to updates on the innovation front. We were excited to announce that we gained 510(k) clearance for the clinically integrated ZEUS System for the Zio Watch. This is an important early step in expanding our platform to more patients who may benefit from preventative and proactive cardiac monitoring. The ZUES system produced in partnership with Verily combines deep learned algorithms with our proven and trusted ECG monitoring service in a clinical-grade long-term noninvasive wearable device. Using a continuous PPG AI-based algorithm, the Zio Watch not only detect AFib, but also characterizes the amount of AFib over time, the calculated AFib burden estimate with accuracy comparable to the Zio XT patch as a reference. This contextualization of patient native presence or absence collected through the monitoring period is important and clinically meaningful to aid in a potential diagnosis. With full integration into our Zio service, the Zio Watch is intended to be complementary to Zio monitors by adding the modality with longer wear times for patients who require long-term monitoring. We plan to introduce the ZUES system for a limited market evaluation in 2023. Another highlight of our ongoing product innovation efforts, the Zio Monitor, our next-generation biosensor, has demonstrated an initial positive impact on patient compliance following an initial launch several months ago. While preliminary, we are encouraged by the impact of this lighter, smaller, and thinner form factor could potentially have on our patient's experience while also providing opportunity for greater manufacturing and scalability efficiencies. We continue to anticipate full-scale commercialization and conversion to this next-generation device in 2023. And finally, we were excited to launch a new clinical resource center on our website to enable clinicians centralized access to clinical evidence, on-demand webinars and case studies. This resource serves as a gateway to publish clinical evidence, offering summaries of significant research, as well as a list of more than 35 clinically relevant published articles to support the clinical validity of Zio. Furthermore, the webinar library post on-demand educational videos featuring respected physicians and clinical staff discussing the impacts and outcomes of their experiences with Zio. In a case study section offers evidence illustrating how the Zio service has helped health care systems improve cardiac patient care. Turning toward progress against the pillars that we have identified for our future success, I'm excited that we have rounded out our executive leadership team to include a number of new individuals, which we believe will be important for growth and transformation of the business in the coming years. Dr.MintuTurakhia, our recently appointed Chief Medical Officer and Chief Scientific Officer, has hit the ground running in his first two months to drive innovation, lead research and evidence generation and enhance our clinical vision. Chad Patterson who joined the Company as our new Chief Commercial Officer in late July, has extensive experience driving revenue growth through strategic sales and marketing execution in global markets, which will be leveraged as we expand geographically, and into adjacent spaces. Reyna Fernandez has also recently joined iRhythm as our Chief Human Resource Officer, to develop and lead implementation of strategies to support our global growth imperatives bringing a wealth of experience in leading HR functions in large global organizations as well as companies with fast-paced, high-growth focused environments. Finally, we are also excited to have Brice Bobzien join us on August 8 as our new Chief Financial Officer, to guide our organization through financial and operational transformation, as well as help position the Company to scale internal processes as we prepare for future growth. I'm very excited to welcome these seasoned leaders into our leadership team and look forward to executing on our vision of building iRhythm into a market leader in the digital health care space. Finally, we are also pleased to announce that we will hold an Investor Day on the morning of September 21 in New York City for analysts and investors of the Company. This half-day event will focus on key elements of a refreshed vision, renewed long-term business strategy, details of our growth pillars, and long-range financial targets. We appreciate that investors and stakeholders have been asking for greater granularity on these topics, and we are excited to be able to host this event in person as well as via live video webcast. In conclusion, we finished the first half of 2022 having made steady progress against our goals and in a strong position to capitalize on the sizable opportunities ahead of us to serve millions more patients. We see significant runway for growth within our core market that we serve today as we continue to shift the standard of care to Zio, the gold standard in this space. With more than $200 million of cash on the balance sheet, and a clear path to being profitable, we continue to invest in our mid- and long-term initiatives that will leverage our technology platform in new geographies and across new markets. We are excited about our future here at iRhythm. I'll now turn the call over to Doug to discuss our financials.