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iRhythm Holdings (NASDAQ:IRTC) Q2 2020 Earnings Call

iRhythm Holdings (NASDAQ:IRTC) Q2 2020 earnings call, held 2020-08-06. Watch the replay and read the transcript on 6ix.

Thu, August 6, 2020 at 4:30 PMendedReplay
iRhythm Holdings (NASDAQ:IRTC) Q2 2020 Earnings Call
Company
iRhythm Holdings, Inc. (NASDAQ:IRTC)
Period
Q2 2020 earnings call
Date
Thu, Aug 6, 2020, 4:30 PM ET
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Watch the replay on this page · 56 min
Results news release
iRhythm Technologies Announces Second Quarter 2020 Financial Results · Thu, Aug 6, 2020

On 6ix: 6ix.com/event/irhythm-holdings-inc-irtc-q2-2020-earnings-call

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Transcript

Automated transcript · Written by software from the replay's audio. It can mishear names and figures; the replay is the record.

0:00 Ladies and gentlemen, thank you for standing by, and welcome to the iRhythm Technologies Q2 2020 earnings conference calls. At this time, offices have been assigned to a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during a session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker for today, Lee Salvo, Investor Relations. Please go ahead.

0:32 Thank you all for participating in today's call. Joining me are Kevin King, CEO, Doug Devine, CFO, and Dan Wilson, EVP Strategy, Corporate Development, and Investor Relations. Earlier today, iRhythm released financial results for the second quarter ended June 30, 2020. A copy of the press release is available on the company's website. 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, which are made 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. All forward-looking statements, including without limitation, those statements related to the impact of COVID-19 on our business, expectations for economic recovery, market expansion and penetration, Productivity improvements, reimbursement, release of clinical data, operating trends, and our future financial expectations, including revenue, gross margins, profitability, and operating expenses, are based upon our current estimates and various assumptions. These statements involve material 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 risks and uncertainties associated with our business, Please refer to the risk factor section of our most recent annual and quarterly reports on Form 10-K and Form 10-Q, respectively, with the SEC.

2:00 This conference call contains time-sensitive information and is accurate only as it's live broadcast today, August 6, 2020. IRISM 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 Kevin.

2:20 Thanks, Lee. Good afternoon, and thank you for joining us. On behalf of the iRhythm team, we hope you're remaining safe and healthy. I'd like to start our call by recognizing the iRhythm team. Over the past few months, I've observed our team rallying to meet the challenges, demonstrating incredible resilience, and operating at the highest level, all while adopting to a new work environment. Despite the challenges, we have continued to deliver our service without interruption to the physicians and patients that rely on it. We recognize the need for high-quality care has never been greater, and the iRhythm team is intently focused on delivering the care needed in today's environment. I'd also like to welcome Doug Devine to our team.

3:07 Doug joined us during an exceptionally challenging and unusual time of our business. Despite that, he was able to immediately step in to provide a very smooth transition, and he has already demonstrated the impact of his leadership on our finance organization and input on our long-term growth objectives. In my prepared remarks today, I'll discuss the key highlights of our second quarter, provide our current views of the market environment, discuss our outlook, and our strategic priorities for this environment. Doug will go into more detail on our financials for the second quarter before we open a call up for questions. As we enter the second quarter, we face many uncertainties related to the impact of COVID-19 and what that would have on our business. To manage this uncertainty, we implemented three operating initiatives. First, to protect and support the health and well-being of our employees, our communities, and our customers.

4:09 Second, to ensure uninterrupted ZEO service delivery. And third, to ensure continued financial strength by adjusting our operating plan. Our team delivered on all three objectives in our financial and operating results for the second quarter demonstrate this. We were encouraged by our second quarter results despite the impact and challenges of COVID-19, which we felt especially early in the quarter. Total revenue for the second quarter of 2020 was $50.9 million, a decrease of 3% compared to the same period in 2019, and a decrease of 20% compared to the first quarter of 2020.

4:54 We saw steady recovery throughout the quarter, and the pace of recovery exceeded our expectations and revised operating plans. Average daily registration rates grew steadily through the quarter and compared to the average weekly registration rates prior to COVID, April represented the trough at 65% of pre-COVID levels and June was approximately 90% of pre-COVID levels. While COVID-19 suppressed the overall market in the second quarter, we believe iRhythm increased its share of the market as measured by our success in three areas. First, compared to legacy Holter monitoring services, Our clinically superior digital platform was proven to be well-suited to deliver services in a virtual environment.

5:44 Our single-use ZEO devices are patient-friendly and eliminate the need for cleaning of equipment between uses. Second, our home enrollment service, enabled by our digital platform, was instrumental in maintaining the registration levels we experienced in the quarter. We expect it will remain an important component of many of our accounts workflows going forward. As we shared in early May, home enrollment represented over 50% of registrations for the month of April. As hospitals and physicians began resuming in-office patient visits, this percentage leveled out to just below 30% as we exited the quarter. We expect to remain at these levels for the foreseeable future.

6:31 and believe this will be a key factor in ensuring continuity of patient care in the event of a continued ramp in COVID cases that leads to reduced in-office patient care. As such, we've been actively working on improving the efficiency of our home enrollment service and are prepared to support 100% of our volume if needed. For example, we recently launched version 1.8 of Xeo Suite, which now tracks includes a tracking feature that provides us and our physician customers with patient and device visibility from registration to report delivery. ZO Suite is an important component of our service as we continue to scale our operations and home enrollment service.

7:19 Lastly, ZOAT demonstrated continued strong traction and meaningful growth over the first quarter of 2021, over 2020. Our single platform solution continues to resonate with our customers as they put high value in streamlining workflows across their cardiac monitoring needs. The experience that our customers have with ZOXT and the high confidence and familiarity they have with our service and platform has benefited ZOAT adoption. Further, ZOAT has unique advantages over traditional MCT technologies that are being recognized by our physician customers. ZOAT utilizes the same form factor as ZOXT, resulting in high patient compliance and wear time, and is backed by the same detection algorithms and AI tools we have developed for ZOXT over the last several years.

8:18 Less than a year into the full market launch of ZOAT, we're very pleased with the adoption to date. We are increasingly confident that we can continue to expand into the MCT market and Take Meaningful Share. While we're pleased to see signs of market recovery, the situation remains fluid, with the level of recovery varying widely within accounts and within regions. So while we've continued to see slight improvement in July, we believe there are several market factors that may lead to suppressed demand through the rest of 2020. Feedback from our commercial team indicates that a number of accounts have effectively worked through their backlog and are now seeing a steady flow of new patients.

9:04 While encouraging, we're not yet experiencing this trend consistently as patient willingness to enter the healthcare system remains varied, particularly in regions that have experienced a strong resurgence of COVID-19 and continued uncertainty as numbers escalate. In addition, were aware that hospitals, especially those in hotspot regions, have limited or even ceased performing procedures deemed deferrable or elective. And nearly all healthcare facilities have adopted new, highly stringent protocols and workflows which are likely to impact patient volume and throughput while they remain in place. Utilizing telemedicine solutions, including our home and service, will help offset these pressures But the adoption of virtual care models has also been varied.

9:56 That said, new account adoption of our Xeo service continues to be at lower than pre-COVID-19 levels. The impact to our third quarter and to the second half of the year remains unpredictable, particularly with the continuing rise in daily new cases of COVID-19, up 3x over May levels. We remain cautious on steady rates of volume recovery as we progress into the second half of the year. However, we do expect to return to year-over-year revenue growth in the third quarter. If current trends continue, we expect Q3 to be in line with pre-COVID levels with volumes growing slightly from June levels. Offsetting this is the expected impact of summer seasonality and its effect on physician prescribing patterns.

10:48 Longer term, we have high confidence in our ability to change the standard of care and continue to gain market share. As I noted earlier, we're focused on the long term and managing our business accordingly with the primary goal of continuity of service for physicians and their patients. Next, I want to spend a minute providing an update on our operations and cost containment measures. Our priority remains on health and safety of our employees and maintaining stringent safety protocols for all in-office functions and employees. We've continued to maintain full organizational capacity through a combination of work from home capabilities wherever possible, daily onsite operations for those groups that must work from the office, and the use of virtual online tools to facilitate group projects, and to provide support to our physician customers and their patients.

11:44 Our field sales activity has remained primarily virtual in most regions through the country. Regarding our cost containment measures, with a noted increase in patient registration levels during the quarter, we have now returned all previously furloughed employees, reinstated salary to pre-COVID levels and resumed hiring for key roles. We are maintaining certain other cost containment measures to preserve cash and liquidity but are making the required investments to continue to scale the business to meet the increased demand and pursue long-term growth initiatives. Turning to reimbursement, as you likely know, CMS published the much-anticipated proposed Medicare Physician Fee Schedule proposed rule for 2021 earlier this week. The issuance of the proposed rule is now followed by a public comment period that closes on October 5, 2020 and will culminate in CMS's final rule, expected on or around December 1, for implementation on January 1, 2021.

12:54 We covered the details of this proposal and its impact on our business during a conference call this past Tuesday, which is archived and available on our website, So I won't repeat all of that information today. On August 5th, CMS published a correction to the relative value units and related information used to determine Medicare payments for the eight new codes associated with external extended ECG monitoring. The correction increases the relative value units for technical codes 93XX2, and 93XX6 and decreases the RVUs for the global codes 93XX0 and 93XX4.

13:44 The remaining four codes associated with the patient hookup activities and final interpretation were revised downward by a small percentage. This correction is incrementally more positive if applied to our 2019 revenues as described earlier in the week. After several years of collaboratively working with the American Medical Association, the Heart Rhythm Society, the American College of Cardiology, and the CMS staff, we are pleased with the very positive impact the proposed outcome will have on our business and especially to have such a significant milestone successfully behind us. Our long-term strategy remains intact, and this includes increasing market penetration with the Xeo platform, increased operating leverage through continued productivity and automation improvements, and expanding the addressable market into new indications and geographies.

14:45 We expect to continue planned investments to drive long-term growth and profitability for shareholders and are as confident as ever in the durability of our business. While we're cautious on the outlook for the remainder of 2020 and would be hesitant to predict a fast recovery, we believe the future of iRhythm has never been brighter. There is a considerable potential for structural changes to how healthcare is delivered, and that will play to the strengths of our digital platform. We're focused on positioning iRhythm to continue to drive the standard of care and how cardiac arrhythmias are diagnosed and managed and delivering our zeal service to the millions. With that, I'd like to turn the call over to Doug.

15:33 Thank you, Kevin. Before I jump into my comments on the quarter, I'd first like to express how excited I am to join iRhythm and to thank Kevin and the board for offering me the opportunity to contribute to the future growth of a great company and a great team. The second quarter of 2020-20 undoubtedly goes down on the record books as one of the most challenging business environments all of us have ever experienced. iRhythm rose to the challenge rapidly and successfully shifting our business model to accommodate our physician customers and their patients. We expanded home enrollments from a single-digit percent to over 50% of volume at peak, maintained traction onboarding new accounts with evolving sales models, and executed internally on many aspects of our operation in a remote environment, while at the same time reducing expenses, preserving liquidity and cash.

16:31 Moving on to the financial highlights for the second quarter of 2020, revenue declined 3% year over year and was sequentially down 20% quarter on quarter. Gross margins were 69.6% for the quarter, We experienced continued traction and expansion of ZOAT, and cash and short-term investments were $114.9 million at quarter end. Taking a more detailed look at the second quarter financial results, revenue recovered throughout the quarter from a low point in April, followed by steady improvement through May and June, exiting the quarter approximately 10% below our pre-COVID run rates.

17:16 We saw that trend continue and gradually improve through July as well. As we think about individual drivers within revenue, we saw continued strong quarter-on-quarter growth for ZOAT. A higher ZOAT mix combined with improvements in revenue cycle management led to ASP increases in the second quarter. On an account and regional level, second quarter volume showed material variances across regions and accounts. 50% of our accounts remained more than 10% off their Q1 run rates, offset by continued onboarding of new accounts and growth of over 10% in run rate over Q1 run rates for 25% of our existing accounts.

18:03 The large number of accounts more than 10% off Q1 run rates indicates many accounts and regions are still well below full recovery. As Kevin mentioned, home enrollment peaked at slightly over 50% of patient registrations early in the quarter before reducing to end of the quarter at 36% of volume. July home enrollment levels have continued to trend downwards into just below 30%. The iRhythm team has demonstrated flexibility to support home enrollments and is well positioned moving forward to meet evolving conditions. Turning our attention to the rest of the P&L, gross margin for the second quarter of 2020 was 69.6%, a 5.1% decrease compared to the gross margin of 74.7% in Q1 of 2020.

18:56 Second quarter gross margin was down due to lower volumes for absorption of labor and fixed costs and some higher costs associated with home enrollment, primarily outbound shipping and logistics costs and labor. Gross margins improved from a low point in April as we moved through the quarter. Non-adjusted operating expenses for the second quarter of 2020 were $55.6 million compared to $56.6 million for the prior quarter, a decrease of 1.9%. Excluding the $3 million milestone payment to Verily, OPEX was $52.6 million, or a decrease of 7.2%. Looking at cash OpEx and adjusting out both the Verily milestone and looking at the cash operating expenses, we're down $13.7 million compared to the first quarter, or a decrease of 24.6%, evidencing the company's strong actions to preserve cash.

19:56 A couple other points to note on OpEx. We partially reinstated stock compensation, resulting in a $9.5 million increase to non-cash OpEx quarter on quarter. Also, bad debt expense, a metric that we've been watching very closely in the current environment, improved 3.2 million versus the first quarter as payments trended stronger than forecasted. Finally, the net loss for the second quarter of 2020 was 20.4 million, a loss of 75 cents a share, compared to a net loss of 10.7 million, or 43 cents a share, for the same period in the prior year. Turning our expectations for the remainder of 2020, while the business stabilized somewhat in June and July compared to the preceding two and a half months, due to the current environment and heightened level of uncertainty surrounding the COVID-19 pandemic, we remain unable to estimate the magnitude or duration of specific impacts on our business, and for that reason, we will not be resuming financial guidance at this time. We do, however, want to communicate to investors the following activities and steps that we are taking to ensure long-term sustainability of the business.

21:11 First, that our ability to rapidly transit from in clinic to home enrollment operational environment remains key to maintaining meaningful registrations and revenue streams during this challenging period. Second, we took significant steps to decrease our spending run rate and preserve cash in the second quarter and we intend to continue to take appropriate measures going forward to preserve liquidity while balancing growing and investing in the business as volumes return. And finally, with over $114 million in cash and short-term investments on hand, we're in a strong position to weather any near-term challenges. Kevin, Dan and I would now like to open up the call for questions. Operator?

21:57 Thank you. As a reminder, to ask a question, you need to press star one on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. And our first question comes from Robbie Marcus with JP Morgan. You may proceed. Hi, this is actually Lillian for Robbie. Thanks for taking the question. Could you provide a bit of color on the use of ZO in acute settings in the quarter? Understanding you probably don't want to break out specific numbers, but how big of a benefit was the acceleration and adoption here, and are these tailwinds something that we can expect to continue to see in the back half of the year, or will this kind of slow down as the virus abates?

22:46 Hi, Lily. This is Kevin. What acute setting are you referring to ZOATs used in hospital? Yes, that's right. Sorry about that. for inpatients. Yeah, that level has decreased and the uptick in ZOAT volume we're talking about is in the traditional ambulatory outpatient cases where the likelihood or possible threat of a life-critical arrhythmia exists. Many of the patients that were in the COVID environment back in the March-April timeframe when we gave the May reporting. Those numbers, too, were a little bit on the smaller side.

23:31 The vast majority here is ambulatory-related traditional market. And we're extremely confident in that adoption rate that we're seeing right now. This is the core market that we're growing ourselves into. Great, thanks. And just one quick follow-up. You know, as you guys mentioned, there's clear benefits to ZO over traditional holders in this environment, given the single-word nature of the device. So what have you been hearing on doctors on how this has impacted their adoption, and do you think that this could have lasting impacts longer-term post-virus things?

24:17 Yes, you know, in a similar way to how we're seeing telemedicine become adopted, you know, due to the pandemic, we're also finding on the Holter side, this is much of an accelerant, COVID's an accelerant to adoption. In many cases, patients are refusing to wear medical devices that have been, that are reused or have been worn by others. There are staff constraints and then, of course, just the ability to do Holter monitoring via home enrollment with a device that has limited capacity or a hospital that would have a limited number of Holter monitors.

25:04 When we have a single-use wearable with essentially limitless inventory to provide to accounts for home enrollment, there's major advantages here. and then of course all of the demonstrated clinical superiority of Zio is weighing in here as well in a big way. Great, thank you. You're welcome. And our next question comes from David Luz with Morgan Stanley. You may proceed. Thank you for taking my question. This is Calvin on for David. Just kind of a related question. Could you comment on how resurgence has impacted either June or July results in sort of either direction in terms of both the underlying demand from regular way ZO patients as well as, you know, to your point perhaps in the context of strain hospital capacity and resurgence hotspots resulting in kind of an increased demand for ZO to reserve vet capacity.

26:10 Thank you.

26:13 Hi, Calvin. It's Kevin. Look, I think this sustained and rather spiky nature of COVID-19 has created a really, really heterogeneous market with demand levels being varied in geographic locations and in accounts. So within areas that are hotspots, we clearly see a high degree of variability in our daily and week-over-week registrations. I would say even in recovered regions, there is non-uniformity. It's almost like a lingering effect from COVID-19. And as we stated in the prepared remarks, many accounts have not returned to full growth yet. So I think the effect of COVID-19 is really and many more.

27:11 That said, where there are opportunities, we do think that we are taking up a larger percentage of the market through the benefits of our single platform, the wearable biosensor that's clinically superior to other approaches. I just mentioned this to Lily. Our ZEO Suite information system is having an impact on workflows as it helps accounts, especially those accounts that have reduced staffing levels due to layoffs and our ability to deploy home enrollment via the ZEO Suite application. And so in the cases where there is demands and patients are getting to the hospital, I think we're getting a disproportionate percentage of those.

28:00 That said, part of the market seems to be cut off, if you will, due to the increase in spottiness and spikiness in the nature of the virus here. I probably may just add one comment here. I do think that accounts are better prepared now than they were in March. Many of them have put in place staff and patient safety protocols. They have limited access. to accounts for us. But they have been able to deal with this feels qualitatively. They have been able to deal with this in a better way than they were back in the March-April time frame. And many, many accounts just completely shut down.

28:47 I think that we hear less of that. This is probably more about capacity constraints right now. Very helpful. Thanks so much. And our next question comes from Margaret Cazor with William Blair. You may proceed.

29:11 Thanks for taking the question. First, I just wanted to see if we could talk a little bit more about the comments on kind of gradual increases or gradual improvements as you went into July. I was wondering if you could quantify that at all a little bit was trying to trying to understand, I can appreciate you're going to return back to year-over-year growth, but what does that look like kind of on a sequential basis? How much above 90% of pre-COVID levels might we be at?

29:42 Doug, do you want to comment on that? Sure.

29:47 Sure. I mean, July was a slight uptick from June, and then I think as we have highlighted, given the COVID situation and given that We're seeing great variability between our accounts. It's difficult to predict where September is going to go in this model and where August may go. So I think we've led you directionally that trending slightly up from 90% and that we're viewing Q1 levels as being a reasonable level of expectation, but we're not in a position to be more specific than that at this point in time.

30:37 Okay, that's helpful. And then also I was curious, the adoption of Zio Suite, and that sounds great, and it sounds like it's getting a lot of traction. I was curious if there's any difference in utilization or growth rates in accounts that have adopted Zio, any noticeable trends, either positive or negative, I would guess positive, that you've seen in those accounts?

31:06 So we've spoken in the past about our innovation stack, the four or five layers and the information system stack was most recently re-architected and launched under the brand XeoSuite. We now have all of our accounts or nearly all of our accounts migrated to XeoSuite. This is the benefit of having a digital information system platform that's cloud-based and so forth. So all of our customers, or nearly all of our customers, to the best of my knowledge, have migrated to ZO Suite and we're getting really, really strong feedback on the benefits of ZO Suite relative to staff productivity.

31:56 And as I mentioned earlier, a lot of our accounts have had staff layoffs and so they're being asked to do more with less and Xeo Suite is helping them when it comes to ordering monitoring devices, tracking where patients are, getting reporting and things of that nature. Plus it's a great productivity boost for physicians if they're working from home because of the ability to use your tablet, your desktop, your cell phone and so forth for Xeo. So I would say that it's been a great success and it's fully deployed and it's having an impact compared to what we had called zeal reports previously.

32:36 Great. And then one last one on my end. Any updates on kind of the high-risk market? I think we were originally thinking that we'd see some MSTOPS and Screen AF data in 2020. Is that still the case or any other updates there? Thank you.

32:51 Sure, Dan. Dan can take that one for you.

32:53 Yeah. Hi, Brandon. It's Dan. Maybe a couple to call out for you there. So MSTOPs, we still expect the three-year outcomes data potentially at AHA in November this year. So excited about that. Screen AF, if you recall, that was on deck to be presented at a conference earlier this year in the May timeframe, which that conference got postponed. So unclear when that data will be presented. I think the investigators are trying to find the right venue or journal to present that data. And then the third one I'd call out for you is Guard AF, which kicked off late last year. That trial was paused in March due to COVID, but it's since then restarted last month. And like our commercial business, the trial has now adopted our home enrollment service as well as some other virtual features. So that one's just getting back up and running after getting started late last year. So too early to give any potential timelines around that one, but like MSTOPS, that does have stroke outcomes data. So we're excited about both of those.

34:14 Great. Thank you. And our next question comes from Kayla Crum, the Jewish. You may proceed.

34:25 Hey guys, thanks for taking our questions and welcome Doug to the conference call and the team. So you guys mentioned in the press release I think that lower volumes in the quarter were in part offset by a higher ASP. So can you give us the split between volume and price if it was meaningful in the quarter? And then what contributed to that price benefit? Is it just standard business mixed with XT? or is that tied to AT? I'm trying to understand if AT is big enough today to be a meaningful contributor at this point.

35:00 I can maybe take the ASP next question and maybe Doug can take the second half or Doug if you'd like to take the whole thing.

35:11 Go ahead. I'll go ahead and take it. So first on the ASP, It was a healthy ASP, kind of a mid-single digits type of uptick in ASP. Now, as you're aware, AT has a meaningfully higher ASP than XT does. And so half of that increase was driven by the change in the mix, where we saw AT units increasing quarter on quarter, and we saw XT units decreasing quarter on quarter. So that kind of magnified the impact you were seeing from ASP. And then the second piece of it is that we are seeing some more general improvements in our revenue cycle management, which led to the remainder of most of the increase.

36:05 Taking the second part of your question on the impact of AT, the impact of AT is growing. It is still well below 10% of our revenue. and, you know, we'd say directionally, you know, as it continues to grow, which we expect it to and have strong confidence that it's going to, we will provide steadily greater detail on the breakouts of AT in the future.

36:31 Great. Okay. That makes sense. And then, you know, it sounds like you guys are or have been sort of looking at your long-term growth vision. I think you mentioned that Doug has already been able to provide some input there. I imagine that's something you guys evaluate and reevaluate over time, but are there any initiatives that you now feel maybe more confident implementing that you may not have otherwise, just given the reimbursement update and expected rate increase?

37:01 Kayla, I think we've always been confident in the reimbursement outlook. Even prior to this Tuesday or Monday or Tuesday's announcements or information out there, we've not altered our strategy because of the favorable reimbursement or potentially favorable reimbursement here, and our confidence has remained the same. Driving new indications, driving geographical expansion, and many more. and keeping our platform fresh and current and highly competitive.

38:11 We're just continuing to do that. We're not taking our foot off the gas here at all, nor are we really changing our strategy.

38:19 Great. Thanks, Kevin.

38:20 Because of the confidence. Yeah, because of the confidence. Yeah, you bet, Tina. And our next question comes from Cecilia Furlong with Canaccord Genuity. You may proceed.

38:35 Great. Thanks for taking our question. I guess I wanted to follow up first on MSOPs as well as Screen AF, but just how you think about the rollout of this and the impact in 2021, but really specifically your thoughts around how screening in high-risk patients plays into a post-COVID or COVID-altered world and really the ability to shift practice.

39:03 Hi, Cecilia and Stan. I guess I would just start by saying as we've looked at what's going on in the healthcare environment today, our conclusion is that there's potentially more asymptomatic or undiagnosed AF in the population than there ever has been. I think that's the first point that we're even more confident that this is a market that we should be going after and investing against. On mSTOPS, it is an important trial given the outcomes data and really the first opportunity to show that targeted detection of asymptomatic AF can potentially lead to improved outcomes, including hopefully a reduction of strokes.

39:55 That's been our hypothesis all along, and we have had and many more. later this year. Screen AF is, you know, important as well, and we're excited for that data to come out. And as I mentioned earlier, GART AF, like MSTOPS, will have stroke outcomes data as well. So we really believe things are, you know, lining up well for us in this initiative.

40:48 You know, it will take time as the clinical data comes out, and we're with that data looking to change behavior. So we're excited about it and believe we're on the right path. I think it's too early to say we'll see anything from a commercial standpoint next year, but we're absolutely moving in the right direction.

41:13 Great. Thank you. And if I could just ask just any updates on your collaboration with Farrelly, ability to really start hiring people into that program again and just kind of at timelines and relative to your kind of pre-COVID expectations. Thank you.

41:37 Kevin, I can take that one. I think we mentioned on our first call I'm sorry, our first quarter earnings call back in May that we had surpassed development milestone in May. So that was an important milestone. And as we have talked about before, we're developing an end-to-end solution, combining technologies from both parties with Verily's StudyWatch, one potential component of that solution. The collaboration has gone quite well to this point, and we continue to tick through milestones relatively on schedule, albeit with minor delays due to product development and specifically hardware development work being more difficult to do in a remote environment.

42:31 But overall, we're on schedule give or take a quarter or two. So nothing specifically to call out in terms of next steps other than continues to move forward. There's a decent chance we'll hit another milestone later this year, early next year. And similarly to my comments on the Simon AF market in general, I think it's too early to point to any kind of commercial impact from this. But again, it is moving in the right direction.

43:06 Great. Thank you, Dan.

43:09 You're welcome. Thank you. And our next question comes from Seraj Kalia with Oppenheimer. You may proceed.

43:21 Can you hear me all right? Hi, Seraj. Perfect. So first question, Kevin, for you or Doug. Doug, forgive me, I did not follow your commentary exactly. So there was a net 5% increase in ASP. ZOXD price was down quarter over quarter, but AT was up quarter over quarter. I guess within the context of the codes currently used, how sustainable are these price increases for ZOAT? And am I right that the AT price increase was in double digits in the quarter? Maybe I didn't connect the dots. Let me see. First...

44:05 Correcting a couple of points. First, I said it was mid-single digit. I don't want to be as specific as pointing a number to it on the pricing. Now, ZOAT prices were very consistent quarter-on-quarter. So what changed is that ZOAT became a much greater fraction of our mix. ZOAT units grew quarter-on-quarter. ZOXT units declined quarter-on-quarter. ZOAT has a significantly higher ASP than ZOXT and so that is accounting for half of the overall ASP on a per unit basis on the quarter. And then as you look at the other parts of the revenue cycle management, we do believe that those are sustainable. Some of it was negotiation, some of it was just doing a better, continuously improving the reimbursement processes.

45:04 Got it. Okay. Now it's clearer. And Kevin, one last and I'll hop back in queue. I presume you all will be supplying the invoices for various components to CMS before the final reimbursement rule comes out? Thank you for taking my questions.

45:25 Sure. As I said on the call, I think it was yesterday, we provided to CMS over 500,000 invoices for are service across contracted, non-contracted, Medicare, self-pay, client bill. They have full access of all various and sundry types of payments over an extended period of time. And they have everything they can get from us. Any other questions? And our next question comes from Marie DeVault with BTIG.

46:20 We're looking forward to getting to know you. I wanted to ask a question about the market share commentary you gave. It's definitely encouraging and it makes a lot of sense. Is there any way to sort of quantify what you're seeing in terms of that share ship? I understand it's very difficult in this environment. And then secondly, Do you believe some of those underlying factors, which sound like they're part of a larger social trend, do you believe that's sustainable to help you maintain some of that market share shift?

46:48 Sure. So the data that we have is iRhythm company-specific data that we gather from our customers. We have very good intelligence on Prescribers, prescribing patterns, prescribing mix relative to traditional holders and event monitors and traditional MCT devices across the thousands of accounts that we have. And we can trend those over time. And through our sales operations calls that we have on a monthly basis, we get a good feeling for how things are trending. And when we see increases in volumes in accounts, we're often asking, are these OEMs coming from new prescribers, existing prescribers, and what is the mix? So the data is gathered internally.

47:41 It's consistent. It's reliable. I would also say compared to other companies that have reported in the category, we were down 3% year over year, and I think other companies that reported were closer to 20% to 25% down. year over year. So that would imply to us in a market that's decreased that we've taken a bigger piece of it.

48:12 Sure, makes a lot of sense. And then I guess my follow-up question would be on your sales rep count in the quarter and whether your hiring plans, I think you'd hope for 160 or so by the end of the year, whether that's being maintained or if there are any changes there. Thanks.

48:30 Yeah, obviously we didn't do much hiring here in the second quarter. We only recently restored hiring of key positions, so really nothing meaningful in the second quarter per se, and a lot is appreciated by what happens in Q3. Don't have a number off the top of my head, but my guess is it's probably going to end up being less than 160 just given the delay in the hiring pipeline and needing to restart that pipeline up again.

49:08 Thank you for taking the question.

49:12 You bet. And our next question comes from Jane Manheimer with Colliers. You may proceed.

49:23 Good afternoon. Congrats on the great progress here. I just had a couple of follow-ups on the reimbursement. Kevin, you said that yesterday CMS published some modifications to the RVUs that go into the payment calc where you'll derive a small benefit.

49:53 I guess you'd call it a correction. And I don't think anybody really codes should equal a global code value. And initially, as reported, they did not. So the sum of the hookup interpretation and the technical code should equal the global code. And in that first pass release, it didn't. And then within a day, it was corrected, and they now do and when that happened the technical code went up and the global code went down by almost the same amount and then the hookup and interpretation were sort of in the fractional percentage movements downward.

50:41 We reported if we calculated 2019 revenues, you know, mix and all of the other things that The impact would have been low single digits, and now we believe it would be high single digit impact year over year to the positive.

51:00 Wow. Oh, that's great. Okay. Thanks for that, Kevin. And another question on, I guess, how things can change between now and December. Historically, does the reimbursement tend to change from the proposed rule to the final rule? and if so, has it veered very much from that proposed rule?

51:24 I think the big factor here is the conversion factor that all of the RVUs in the physician payment system get multiplied by to arrive at a price point. And what was proposed in the rule here was about a 10.6% decrease in conversion factor across all categories, not just the code set that we use, but for everything. And my guess is that that is going to be heavily debated. It's a fairly large decrease, and I think in prior years it's been nowhere near that level.

52:10 There is a reason for that, and it's my understanding. I'm hoping I'm correct, but physician payment for codes that are called evaluation and management, E and M codes, went up substantially, and that CMS is required to operate in a balanced budget format, so they can't just pile on more expense. When something goes up, something else has to go down. And it seems like the best way that they were able to facilitate that was to just drain more water out of the pool through the conversion factor. So my suspicion is in the budgeting process that that's going to be hotly debated. As far as on the code structure side, the process was so thorough and so complete, I'm hoping that there's not much to change. But of course, if there's a common period, then we'll see what happens.

53:08 Great color, thanks. So last one from me then, just in terms of your home enrollment trends. So let's say that volumes did return to near normal pre-COVID level, call it 95% to 100%. Where does home enrollment registration plateau in your view?

53:31 You know, it's a good question. We said in the prepared remarks, Gene, that we think this 30% level, slightly plus minus a point or two around 30%, feels right to us. A lot of accounts are loving, if you will, the ability to order things remotely without having patients come into the office, particularly patients that have already had prior studies or exams, drug Titration, follow-up to ablation, subsequent CO patches, things of that nature, plus even new cases which are being seen today. So I think that that's here to stay, and it's probably going to get built off the backs of what we hear about telemedicine being here to stay as well, that telemedicine had been kind of on the sidelines for a long time, then it got pushed to the forefront and many physicians are really liking it. Many physicians are feeling that they're doing a very good job in seeing their patients remotely and probably won't go back.

54:40 I'd call it about a third of our business. 30% of our business is probably the plateau that we're hoping for. We're able to do 100% or very close, very soon be able to do 100%. So if the COVID pandemic here spikes up, God, we hope not, but if it were, We would be able to sustain our operations all the way up to 100%.

55:03 Fantastic. Thank you. You're welcome. And ladies and gentlemen, this concludes our Q&A portion of today's conference. Now I'm going to turn the call back over to Mr. Kevin King for any closing remarks.

55:18 Great. Thank you, operator. Thank you, everyone, for joining our call today on our Q2 2020 conference. Earnings Call Updates. We appreciate your continued interest and support in the company and continue to wish you great health and great safety throughout the spirit of time. We'll look forward to talking to you later. Thank you. Bye-bye. Ladies and gentlemen, this concludes today's conference call. Thank you for participating and you may now disconnect. Everyone have a great day.

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Speakers

Lee Salvo

Investor Relations

Doug Devine

CFO

Kevin King

CEO

Dan Wilson

EVP Strategy, Corporate Development, and Investor Relations

Margaret Cazor

Analyst, William Blair

Kayla Crum

Analyst, Jefferies

Cecilia Furlong

Analyst, Canaccord Genuity

Seraj Kalia

Analyst, Oppenheimer

Marie DeVault

Analyst, BTIG

Jane Manheimer

Analyst, Colliers

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