iRhythm Technologies Inc

NASDAQ:IRTC

Earnings Call Transcript 2018-Q4

[Operator]

Good day, ladies and gentlemen, and welcome to iRhythm Quarter Fourth 2018 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, today’s call will be recorded.

I would now like to turn the call over to Lynn Lewis with Investor Relations. Ma’am you may begin.

[Lynn Lewis, IR]

Thank you, Sidney, thank you all for participating in today's call. Joining me are Kevin King, CEO; and Matthew Garrett, CFO. And Derrick Sung, EVP of Strategy and Corporate Development. Earlier today, iRhythm Technologies released financial results for the fourth quarter and full year ended December 31, 2018. 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, our examination of operating trends and our future expectations, which include expectations for hiring, growth in our organization and reimbursement, guidance for revenue, gross margin, operating expenses in 2019, 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 the risks and uncertainties associated with our business, please refer to the Risk Factors section of our most recent quarterly report on Form 10-K with the Securities and Exchange Commission.

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. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 12, 2019.

And with that, I'll turn the call over to Kevin.

[Kevin King, CEO]

Thanks, Lynn. Good afternoon and thanks for joining us. Strong momentum carried us into 2018 and we exited the year even stronger. Our full year revenue was 147.3 million representing 55% growth over the prior year after adjusting for topic 606 and exceeding our guidance range of 142 million to 144 million.

Gross margin for the full year improved 2.9 points. Fourth quarter revenue was 43.2 million up 56% when compared to the prior year period and gross margins increased 275.6% a 3.4 point improvement over the same period in 2017.

I’m exceptionally proud of our team’s many accomplishments which included substantial progress on the long and short-term goals we set for our organization. Briefly this past year, we achieved our annual sales expansion goal reaching 110 reps, increased sales productivity in terms of time to ramp as well as peak productivity, published three major studies in peer-reviewed journals, highlighting the superiority of our Zio service and opportunity to expand our market.

We now have 26 published studies and over 30 new studies in our pipeline. We reached nearly full reimbursement coverage in neural network contracts in the US for our Zio XT service and we made strong progress on Zio AT contracting and launch this new offering to targeted accounts. It’s clear to us that the power of Zio platform is helping our customers to achieve meaningful improvements to clinical decision-making in less time and at lower costs than previously possible.

We are in our strongest position to-date, both operationally and financially, Zio has proven clinical superiority. The completeness of our Zio service combined with the strength of our sales and support organizations gives us confidence to project 2019 year-over-year revenue growth in a range of 36% to 40%.

I would like to take a few minutes to briefly summarize our recent progress and offer some thoughts on milestones and goals for 2019 and beyond and then I'll turn the call over to Matt for further review of our financial performance and guidance for 2019.

Starting with our commercial organization, sales force expansion continues to be a key factor fueling our growth. Over the past several years we've been successful in adding and integrating 20 to 30 high quality reps per year. As noted earlier, we reached our hiring goal for 2018 in the first half of the year and focused our attention to sales training and the buildout of our customer care organizations for the remainder of the year. This focus paid off as 2018 hires have shown higher levels of initial productivity than the new reps we brought on in previous years.

Equally important are most tenured reps those with three or more years of tenure continue to increase to their peak sales and now average 2.5 million in sales annually. This average peak sales level continues to move higher as a result of greater brand awareness, impact to clinical studies, greater in-network contracts and a focus on large integrated delivery systems.

While it's difficult to predict exactly where the upper limit may be, we believe the peak sales can move even higher.

We plan to add 20 to 30 reps in 2019 ending the year with a sales organization of about 130 to 140. Importantly, we will continue to expand our commercial team to whatever cost-effective size is required to capture the full and untapped market potential that lies in front of us.

Turning our attention to account penetration, we continue to see increased adoption in new and existing accounts, driven by the recognition of the proven superiority and completeness of our platform and increased size of our sales force. A key measure of new account velocity is measured by the time it takes for a new prescriber to reach 50 initial Zio prescriptions. At the end of 2018, we estimated this metric to be roughly three months an improvement of more than 50% from the prior year.

Zio AT is another key component to our market penetration strategy, Zio AT allows us to address an important subset of patients who have higher acuity conditions such as syncope or unexplained loss of consciousness and may require more immediate physician notification. Zio AT provides a meaningful opportunity to gain account penetration by enabling us to offer an even more complete solution for our customers.

Results from accounts within our limited launch phase is encouraging, each are migrating from legacy options to the complete range of Zio XT and Zio AT.

In January, when presented data that demonstrated the Zio XT acceleration affect taking place in a representative account that recently adopted Zio AT. The data available on our presentation on our website cover the period from December 2016 to December 2018. It highlighted that Zio XT share grew from initial 10% of total account volume to a combined 90% with Zio XT at 76 and Zio AT of 14. While still in the early days of our Zio XT AT experience we believe this data is representative of the opportunity that lies in front of us.

It’s worth reiterating the primary reason for our phased rollout of the Zio AT as that the number of possible contracted buyers for Zio AT is significantly less than that of Zio XT. Many health plans continue to have negative MCT coverage decisions, stating that the technology is either still unproven or too costly compared to alternatives. And those that do cover MCT the policies are often narrowly limited in indications or require a failed first-line testing. We expect to have completed our initial contracting efforts by the first half of this year and will then more aggressively expand AT into the market at that time.

We believe our accelerating market share gains are coming not only from our proven clinical superiority but from the completeness of our service enabling us to emerge as a standard of care in long-term continuous monitoring. Early in our business lifecycle we recognize that traditional algorithm approaches to detecting irregular heart rhythms was a challenge and would likely not scale to meet the needs of the future.

If you rate for example over a terabyte of patient ECG data each day, a number that continues to grow with increased volumes and longer patient wear times. It’s also well understood and documented in the scientific literature that computerized ECG interpretation error rates approach 50% that can be as high as 70% for certain complex arrhythmias. Increasingly, there was a reliance on experts for correction and most ECG algorithms are based on the 1980 MIT-BIH database that only contains 47 subjects with four different arrhythmia classes.

Our development investment to create a highly scalable proprietary AI platform was driven by three factors. One, the opportunity to substantially improve the accuracy of ECG analysis, reducing the rate of misinterpretations and inappropriate patient management. Two, the expected increasing Zio volume and increasing wear times in a growing complexity of each patient’s Zio record. And lastly, AI allows us to move away from outdated feature engineering techniques such as T wave protection to utilize all of the information contained within an ECG record. This means our future AI capabilities will not only accurately diagnose patients with cardiac arrhythmias, but also be capable of predicting a patient's future risk allowing for earlier medical treatment and possible prevention.

Some of the benefits of our AI investments were published in a major study in January issue of Nature Medicine. The study described the capabilities of our deep neural network which we collaborated with Stanford Machine Learning Group, using our proprietary Zio database. The Nature of publication highlights that we have the first and only set of deep learning artificial intelligence algorithms demonstrate to exceed expert interpretation by board-certified cardiologists across 12 diagnostic classes of cardiac arrhythmias. We’re increasingly excited about the opportunities arising from the market expansion of through our clinical research efforts. As a reminder of the legacy ambulatory monitoring market where we’re rapidly taking share is focused on the initial diagnosis of symptomatic patients and amounts to over 4.5 million tests per year in US. We estimate that our share of its existing market segment is now on the double-digits as we broaden our presence and displays legacy Holter events and mobile telemetry with our Zio XT and AT services.

In 2018, we published a KP-RHYTHM study, which expanded our addressable market into the growing population of at least 1 million patients who had already been diagnosed but required ongoing monitoring and care of physician of the arrhythmias to manage their conditions.

We also published the results of two additional trials mSToPS and the Mesa study, which are helping us to develop to asymptomatic or silent AF market that could open up an additional 10 million plus patients. We have a robust pipeline of clinical research and you can expect to see additional studies coming out of the year that will demonstrate the clinical utility, comparative effectiveness and strength of our Zio platform across a variety of indications.

In 2019 we look forward to continuing our momentum with strong execution across our business, confidence in our highly competitive positioning and differentiation includes Zio’s proven superiority, the growing strength of our AI algorithms and data analytics and the completeness of a platform that routinely creates meaningful value for our customers, large and small.

With that I would like to turn it over to Matt Garrett our CFO for a review of our financial results and guidance for 2018.

[Matt Garrett, CFO]

Thanks, Kevin. We're extremely pleased with the financial performance for the fourth quarter 2018, not just the top-line revenue growth, but more importantly our execution on the P&L. Our continued focus during the quarter on sales force productivity, sales infrastructure support and large integrated system penetration drove accelerating top-line growth. We also continue to demonstrate material improvement in our gross margins while our spending profile net of one-time adjustments for annual bonuses, commissions, and long-term debt restructuring gives us continued confidence in expectations for our long-term financial performance.

Highlights for the fourth quarter 2018, as adjusted for topic 606 are as follows:

Revenue growth of 56% year-over-year and sequential growth of 13%, non-adjusted gross margins of 75.6% an increase of 3.4 percentage points over the prior year, continued success of 80 launches in key pilot account which contributed to the accelerated adoption of XT and iRhythm as a full solution in those accounts and growth in our sales force productivity through the development and onboarding of new reps as well as the continued impact of penetrating large integrated systems leading to confidence that the top end of our rep productivity thresholds can in fact continue to increase over time.

Taking a more detailed look at fourth quarter results as adjusted for topic 606. Revenue for the three months ended December 31, 2018 was 43.2 million, an increase of 56% year-over-year and 13% sequentially. As Kevin noted, sales force productivity levels continue to rise as we penetrate these large integrated systems and as reps hired over the past year achieve meaningful productivity levels.

We have spoken in the past about positive trends in our growth trajectory which remain compelling and in turn support the confidence we project in the business and our ongoing investment thesis that continue to deliver benchmark performance.

Some of the trends we’d like to highlights include: the continued positive impact of mix shift to contracted claims, small but regionally important payor contracts continue to flow in for Zio XT as we approach peak pricing for that portion of our business. Our attention now turns to Zio AT Mix that will continue to drive meaningful ASP growth for the foreseeable future.

Volume to price mix for the quarter was 85% to 15% a ratio that we expect to continue into 2019. For the second quarter in a row same-store new store unit growth ran at a robust 60% to 40% split. We view this mix as a positive sign of our ability to more deeply penetrate existing accounts as we focus on new large integrated systems that tend to have a slightly longer lag times to onboard than smaller accounts. As one example of this measure, our top 25 existing accounts grew a combined 50% year-over-year and 17% sequentially. Nearly all of them exhibited double-digit annual growth.

We continue to see significant improvements in sales productivity levels and as a result, we now believe that 2.5 million in sales is no longer the ceiling for third and fourth-year reps but rather the potential average. As of now new reps for achieving material levels of productivity earlier than we’ve seen in prior years.

And finally, we continue to see dramatic XT volume expansion in accounts where we have piloted AT. In the month post AT launch we experienced a 42% increase in average XT volume, this continues to validate our confidence in the pull-through impact AT will have on XT volume upon broad commercialization of AT.

In summary these trends continue to speak to our ability to scale this high volume business in a meaningful way around our strategic approach to opening and penetrating large volume accounts, which is a key component of our growth strategy.

Turning our attention to the rest of the P&L. Non-adjusted gross margin for the fourth quarter of 2018 was 75.6% compared to 72.2% a 3.4 percentage point improvement over the same period in 2017. In the quarter we had a non-standard cost adjustment related to a vendor rebate leading to a positive one-time 0.5 percentage point impact on margins. Excluding this adjustment gross margin still expanded to 75% over a full percentage point of sequential growth.

Operating expenses for the fourth quarter of 2019 were 44.2 million compared to 30.6 million for the same period of the prior year. Growth and spend continues to be driven by sales force expansion and sales force support hiring needs, bad debt expense and stock compensation continues to run higher as well due to over delivery on our top-line growth.

It is important to note that OpEx was approximately 4 million higher in the quarter than we anticipated due to a number of material one-time adjustments, most notably for commissions and annual bonuses booked in Q4. Even with these charges the 44% increase in spending was our lowest year-over-year quarterly growth in OpEx in over two years. While we will continue to keep a close eye on OpEx growth it is our present plan to continue our substantial investment in the growth drivers as I will discuss in guidance momentarily.

One final note, on October 23, 2018 we repaid an existing debt obligation using proceeds from the issuance of debt from a different lender, Silicon Valley Bank and accounted for as a debt extinguishment. As a result, we incurred a total loss on existing debt of $3 million.

Finally, the net loss for the fourth quarter of 2018 was 14.7 million or a loss of $0.61 per share, compared with a net loss of 11.1 million or a loss of $0.48 per share for the same period of the prior year.

Turning to our guidance for 2019, we anticipate revenue for the full year 2019 of 201 million to 206 million, and we would expect similar quarterly patterning that we have seen historically. This represents annual growth of 36% to 40%, demonstrating our growing confidence in our ability to scale the organization appropriately as we continue to produce benchmark top-line growth. Gross margins for the year is expected to range from 75% to 76%, continuing our trends of both price and cost improvements.

Finally, we expect operating expenses to range from 191 million to 197 million including 28 million to 30 million for research and development and 163 million to 167 million for SG&A. This range reflects our expectation that OpEx will continue to trend downward even as we continue to scale the business.

We’d now like to open the call up for questions. Joining me for Q&A is Kevin King, President and CEO; and Derrick Sung, our Executive Vice President of Strategy and Corporate Development. Operator?

[Operator]

[Operator Instructions] And your first question comes from David Lewis with Morgan Stanley. Your line is now open.

[David Lewis, Morgan Stanley]

Just a few questions from me if you bear with me. Kevin I’ll to start with you obviously. Very strong finish to the year and encouraging guide above the consensus to start the year, so obviously you seem to have momentum in the business. Can you sort of break down with us, in the year what’s underlying that confidence and how much of this is just core XT traction or any if at all material contribution from AT? And then I have some follow-ups on spending.

[Kevin King, CEO]

Sure. Hi. David. Look AT is -- will eventually become a material part of our business, but at this point, it's still early days. And the AT market opportunity, as I described is roughly 10% of total. So if you are going to be modeling, I think the way to model it is it’s about XT penetration, it’s conversion in new and existing accounts, it’s increased sales productivity, it’s increased productivity from a number of new salespeople, it’s physician confidence driven by the clinical superiority of our product as measured by our clinical studies, I think those are the main drivers for us here.

[David Lewis, Morgan Stanley]

Just thinking about spending here for a second because you had some commentary in the script here. So obviously you are still guiding to modest SG&A leverage here in 2019 which we didn’t see in 2018. Can you just talk about the confidence in sort of the unit profitability model here? On one hand you have gross margins heading higher rep productivity is heading higher, and you taking up these expectations. But still your spending materially sort of sales force expansion. That’s the right way to think about the business this year and next year and maybe talk a little about just your confidence that the incremental sales acquisitions coming at a high contribution margin but you’re spending significantly to drive enhance growth? And then I have a quick follow on R&D.

[Kevin King, CEO]

I think you got David, the total addressable market for us is quite large even when we are growing at the rates we have been growing, we’re still a relatively small share, and we need to continue to invest in the commercial side of our business. If you look at the R&D spend the R&D spend is a healthy increase as well because we've got a pipeline of new indications, new products, new technologies that we’re investing in over time. That said we’re increasingly confident that there is strong leverage and strong pull-through in our business you’re beginning to see that effect now where the OpEx growth rates are slowing, while the revenue growth rates are continuing to be in the upper tier of our peer groups and so forth. So I'm totally confident and I think as far as profitability, it's just not that far off, Matt I don’t know if you want to comment on what timing our range or something like that but if you’ve got a number?

[Matthew Garrett]

Yes I don’t know if we -- David, I don’t know again if we really talked specifically about the time. I think we’ve talked about the fact, as long as we continue to define these investment opportunities for us to drive top-line growth we’re going to do that, obviously we’re guiding to the high-end of our sales rep numbers from IPO earlier in the overall process. We’re not sure we did achieve the high-end of that range. So there's always a potential for additional spend there if we can continue to see that growth trajectory. All of that said we grew Q4 versus Q4 even with those one-time adjustments of 44% and the guidance we just gave I think indicates that the midpoint less than 30% OpEx growth. So we’re clearly seeing the traction in the business that we thought all along. If you want to tie it down I think at this point we’d be looking at 2020 as a timeframe to start talking about EBITDA and that being breakeven.

[David Lewis, Morgan Stanley]

And just one quick follow up on spending and I will jump back in queue. R&D as probably you’re spending more money in R&D but what’s interesting is that number is up on absolute dollar basis in ‘19 versus ‘18, yet we’re pretty far long with mSToPS Screen AF. So it feels like that number maybe equal parts development and research, can you just flush that out a little bit for us because I think where those absolute dollars going given your major trial expense may or may not be behind us? Thanks so much.

[Matthew Garrett]

So David, the trial expense is not included in our R&D number, it’s in our SG&A number. So when you’re looking at R&D, you’re looking at product technology algorithm indications new product expansion, innovation.

[Operator]

Our following question comes from Robbie Marcus with J.P. Morgan. Your line is now open.

[Robbie Marcus, J.P. Morgan]

You’re building your reps, your growth is extremely strong and strong going out of ‘18 and into ‘19. Can you help us understand how much of that is driven by opening new accounts and how much penetrations left at your existing account? So if we think about how much more of the sales force you will need, how much is already opportunity you have in place to go capture and how much is you have to go seek out?

[Kevin King, CEO]

Robbie that’s involving -- I should say there’s evolving answer to that question. As you know we have guided for the 50-50 same-stores new store split for quite some time. That changed in Q3 where I think our initial thoughts was ahead a lot to do with some more seasonality in the business. But what we’re seeing is that we’re actually having the ability to further penetrate existing accounts in ways that our potentially expanding our customers’ ability to sell Zio product. What I mean by that is we’re able to go further upstream into emergency rooms and even in the primary care in a way that was hard for us based upon our knowledge of accounts use of Event and Holter that would been an incremental add to that particular account and we’re going in the opposite direction as it relates to the neurology department and some of the other new indications that we’re identifying. So basically what I think we are seeing is not with EHR integration with our approach of going after larger accounts. And with these additional kind of added benefits to our sales model we are seeing the ability to deeper penetrate in existing account than we’ve seen in the past. Does that answer the question?

[Robbie Marcus, J.P. Morgan]

Yes, that’s really helpful. And then maybe just two other quick ones, I will get it together. First how do we think about what’s in your numbers now from some of the new indications like KP-RHYTHM, are you starting to see a systematic at all in your treatment numbers? And then maybe just help us understand how the new neural learning will play into the algorithm when that all will hit the algorithm and is that something you are going to roll out and make a big deal about to doctors and physicians? Thanks.

[Kevin King, CEO]

Robbie I would say that studies KP-RHYTHM are still in the awareness phase. There have been a number of published articles that came out ahead of KP-RHYTHM the significance of atrial fibrillation burden. And while physicians are highly aware of the importance of it they are only now starting to internalize it and figure out how we can help them to better manage their patients with paroxysmal AF. So I think out of the million patients that are in that tam are in very earliest stages and that we’ll rollout over time. That said, there's no question that it takes a lot to characterize atrial fibrillation beyond just presence of atrial fibrillation and that's what the study was meant to prove out. So I think that’s the perspective we have on that.

Relative to the deep learned algorithms. These are in operation now. We received FDA clearance for a release, in particular release last year. We had clearance prior to that but we did another version upgrade and we’re seeing material benefits in our business and the way that we described it to our physician is look it’s all about helping you to make a confident diagnosis and treatment decision for your patients and most physicians know that traditionally algorithms have not been very accurate and it’s a cause for concern for them. Now the paper highlights that we’re superior or equal to expert cardiologist and I think that that's giving people great confidence in their ability to prescribe Zio and I think that's going to be a big driver for us as we go forward on the prescribing pattern side.

[Operator]

Thank you. Our following question comes from Jason Mills with Canaccord. Your line is now open.

[Jason Mills, Canaccord]

Wanted to start with I guess a bit of 20,000 foot question. Specifically the inertia that you’ve talked about since you really launched several years ago being the status quo, and that's what you'll say now but I’m just wondering more broadly. If given your success -- if your success suggests that you're seeing the flood gates open a little bit with respect to that inertia and those that still to the state have not in a large way decided to change to a patch based EKG monitoring algorithm, the evidence of your recent growth is suggesting that the flood gates are either opening or about to open there. And then I guess the second part of the question is the prototypical competition question besides inertia given your success usually breeds interest and trying to replicate it. Is there anything of note, in terms of different competitors out there they think that you see on the horizon?

[Kevin King, CEO]

Thanks for the words on inertia and progress that we're making here. I’m a little bit more conservative than most, Jason, and that I don't believe healthcare is ever binary, off then it’s on. So I'm not sure I would use the word flood gates, I would use steady momentum, progress driven by two major factors right that we are proven to be clinically superior and we’re offering the most complete solution for our customers. And those two things need to go hand-in-hands, there is an and in between there, clinically superior and complete and that's what's allowing us to penetrate these accounts. So we are increasingly confident that we are the leader in the space. I don't really see competitive threats in a big way, our competitive threat is really all about helping customers to change their status quo as you mentioned earlier in your first comment there. So it doesn't appear that anything is really immediately on the horizon and if it were it would need to be proven clinically, it would need to be as complete as iRhythm is helping people to understand how to diagnose or manage their patients to the level of effectiveness that we have.

[Jason Mills, Canaccord]

Kevin that’s helpful. And then Matt I know we’ve talked about my model and certainly trying to understand the productivity of your sales force and project forward and these models can get somewhat inclusive and comprehensive but I’m wondering if you would be willing to talk a little bit about some of the metrics that you went over in a little bit more detail. It’s quite amazing to me that you're still not seeing the upper limits or least you don’t think you’ve seen the upper limit of your productivity curve. I think you also mentioned that the newer reps are becoming very productive, highly productive even quicker. I'm wondering if you can quantify that even a little bit further to help us refine our models? And then Kevin you mentioned that you will continue to add as you see necessary. I know in the past you sort of talked about an upper band to your sales force, it seems like maybe at this point in time you’re not sure if that upper band is going to be adequate enough to really go after the targeted addressable market, maybe you could address that? And then I had one more follow-up.

[Kevin King, CEO]

There is a lot there, let’s see. I think Jason you starting with kind of what has changed from our perspective as it relates to sales rep productivity both in terms of scale and in terms of when they can get to scale and why has that so dramatically changed. I think that is a number of reasons for that. Some of them we've known and some of them come along a little bit more lately that leads us to not quite knowing where that peak is, I will give you some examples. Remember when we set the original model at four years in a 4.5 million that was four years ago when we probably were only 40% to 50% contracted with just a few major players other than CMS. So now we’re nearly complete on the Zio XT side of the business. Going to accounts where you are nearly complete on contracting versus ones where you are less than 50%, I think automatically provides you a leg up.

Secondly, I think that we've done a lot in the last two to three years on hiring and training, bringing on better people, training them in a more unique and complete way. We just got back from National Sales Meeting last week where I believe the feedback was quite strong in the discussion around how we go about these large integrated systems and how we attack them. I think that that has improved. I think the ability for us to offer a full EHR solution has helped in our ability to onboard, particularly the large account. Some of those accounts will not work with you if you do not have bilateral EHR capability.

We have developed over the last couple of years part of our expenditures something you heard me talk about is the infrastructure support for the sales team not the least that which is onboarding teams. We literally have full-time individuals who work with the sales team to onboard these large integrated systems to ensure that the run smoothly.

And then finally, I just think it's a combination of all the clinical studies and brand awareness we have seen is really making a difference when we do end up approaching an overall account if you will. And I think when you add all of that up, plus what I answered to Robbie earlier about the ability to penetrate more deeply in existing accounts, even more than we probably thought early on, all of those indications have led us to be able to have a stronger position around sales rep productivity and where we’ve taken the cap up to 2.5 and are now calling it an average.

[Jason Mills, Canaccord]

That's very helpful. Thanks for the detail and then lastly maybe spreading the low ground for Derrick who is available. mSToPS in screening market if you will, could you help us understand or level set us with respect to the process. We obviously have three year data that we’re awaiting to us and I presume the folks with right mSToPS or the Zio into guidelines would want to see those through your data. Maybe you could explain the process of getting written into the guidelines specifically for this new target addressable market and just perhaps walk us through process and proceed here? Thank you.

[Derrick Sung, EVP Strategy and Corporate Development]

Sure Jason, the following AF market is a market that we’re very excited about. We've become increasingly optimistic about it as we publish our mSToPS data and really been the center of these discussions around developing the market. And to your point it does require a significant market development effort. That market development effort starts with evidence, clinical evidence and also health economic evidence to demonstrate that we can not only find patients with atrial fibrillation in this high-risk to asymptomatic population but that finding then this will then lead to treatment which will lead to earlier improvement of health outcomes and ultimately health economic benefits. So for the mSToPS study in particular as you mentioned that is data that will be coming out at the three year endpoints. So that will certainly help drive guidelines which are written by societies and the professional clinical community, as well as coverage decisions which are driven by the peer community.

Now it’s not about mSToPS alone however, we have -- we and others are investing an additional clinical evidence to drive forward this market. In our case there was another study that we’re involved in called Screen AF and that’s a similar asymptomatic at risk, at home study evolving the use of our Zio. That study we expect to be fully enrolled some time this year in 2019 and potentially have a read out of topline data potentially late this year or maybe early next depending on timing.

We’re also are aware that we’re not in this effort alone and that there are other stakeholders such as pharma companies, payors and ourselves in addition to the clinical community who are very much interested in developing this market. So all of that I think is a very optimistic outlook on this market's, it is long-term but those are kind of the sets that are going to be required to develop this market, so it will take a little time.

[Kevin King, CEO]

Jason, just back on your comments on opening the flood gates. There is an interesting stat out there on oral anticoagulation therapy penetration, in that I believe Warfarin still holds 55% market share after the massive investment in clinical evidence of the benefits of oral anticoagulation therapy. I think it's just the conservatism of healthcare and the requirement for proof not only on the clinical side on the cost-effectiveness side that kind of taps down the market. That's very different from say technology adoption of iPhones or any other type of trend that we see on consumer side.

[Operator]

Our following question comes from Glenn Novarro with RBC Capital Markets.

[Glenn Novarro, RBC Capital Markets]

I have one on the sales force and then few follow-ups. Kevin you talked about adding 20 to 30 reps in 2019. Can you talk about where you are in the hiring process, how many you have hired and how confident you are in getting these reps on board in the first half of the year? And then I have two follow ups on AT.

[Kevin King, CEO]

Hi, Glenn, Kevin. Look our goal is to get most of these people in place in the first half of the year. So we will hopefully get there, hiring right now is taking place. I don't have the exact number of people that we have hired off the top with my head. I would expect that I will follow the same trajectory that we have in the past. We have gotten pretty good at doing about 10 a quarter and if we follow that we should get pretty close to 20 by the midpoint of the year and possibly a few more towards the back of the year but we’re going all out, all the territories are open, all the recruiting is taking place all for all of the open assignments. Initially nothing holding us back other than just I believe hire the right people and that's a difficult process at iRhythm that we really spend a lot of time qualifying all employees to make sure that they've got the right wherewithal to do the job, not only for today but for tomorrow.

[Glenn Novarro, RBC Capital Markets]

And then my follow-ups on AT, Kevin in your prepared remarks, you talked about some reimbursement challenges for AT. Can you talk about what you're doing to resolve these reimbursement challenges with the payors and timing of this resolution? And then also you talked about mix in AT pricing. Can you talk about the price premium AT is getting over XT and I'm assuming that's been a pretty sustainable premium since its launch?

[Kevin King, CEO]

Look I'll the second one first, so the price premium over XT is about 2 to maybe 2.5 times, you can go to Medicare websites and you can look up pricing and so forth. But it’s based on the averages to 2 to 2.5 times. The comment I made about contracting with AT is not specific to iRhythm it's specific to the code. The MCT code has been around for about 10 years and it's an expensive technology and the evidence the peer-reviewed publications don't support it’s used as a broad tool for ambulatory monitoring. It prefers Zio XT as a proven product and in the past it supported things like Holter monitors and Event monitors. That said there is a narrow indication for AT when patients need more timely delivery of information that's associated with their risk of their acuity and it's in those cases that health plans do allow -- do have a positive coverage policies and do have the ability to contract. So we've been driving like crazy to get insight in that work with those we’re making very good progress, and I think we're going to wrap that up to the level that we can by the midyear, and that we will remove any patient friction that we might experience going forward. That said organizations like the BlueCross and BlueShield Association, which represent about 80 million to 90 million lives in United States has a negative coverage policy for MCT. So that's just says that any BlueCross and BlueShield number you don’t have to pay for their product out of pocket or they need an alternative test. And depending upon where you live BlueCross and BlueShield could be the dominant player if you will, in that market, and so it requires us to be very sensitive to our accounts and understand how they are going to deal with prescribing Zio ET when the percentages that their patients maybe high, it's not in all cases but it may be high and that's a little bit of a dance that has to be done because we certainly don't want to jeopardize the high degree of penetration that we have with payors amongst the XT business. So it's more of a strategic tiptoeing if you will with accounts and figuring out how to bring on the right accounts.

And there's only about 400,000. This is only 1/10th of the whole ambulatory cardiac monitoring market and the reason why it's there is largely because the coverage policies don’t allow to get any bigger.

[Operator]

Thank you. Our following question comes from Joanne Wuensch with BMO. Your line is now open.

[Joanne Wuensch, BMO]

In no particular order, you mentioned emergency rooms and primary care settings, how much do you think you’re penetrated or if served selling Zio into these markets?

[Matthew Garrett]

Hey, Joanne, it’s Matt. I would argue that it’s very, very small at this point, you're only going to see in some of our larger integrated systems and clearly it’s probably some of the more mature systems that we had on board for quite some time. So it's very anecdotal and I don't think that we’re in a position yet to put any sort of figure on that.

The way in which our service works is that the Zio can be prescribed by anyone across a delivery network and so if a patient were to enter the emergency room in the status quo days, they would -- cardiac arrhythmia symptoms, they would then get an appointment to go to cardiology to get Holter monitor, take the Holter monitor home wear it bring it back and eventually the report would have to find their way to their primary care physician or the person who saw them, they won’t see the same person that they saw in emergency room.

In the cases where emergency departments are primary care or using Zio in the new world you can prescribe Zio it can be on the shelf in the emergency department, you leave with it and the next time you come back to the hospital your report is done. And so this is a workflow enabler if you will or improves the workflow inside these large integrated delivery systems, and I'm confident that more and more -- we’re going to see this more and more as these digital services like ours enable people to deliver care at the time it's needed and do it in less labor and less cost.

[Kevin King, CEO]

I think that’s really good point, Kevin here. Just to add to the subtle nature of this, a good portion of these individuals who are coming through the emergency room feel that they're having some sort of palpitations or events that in actuality is something else. So the ability to capture them in the emergency room, the system understands that the ability to rule out is incredibly valuable because it does not wait cardiologists’ or EP’s time to see patients that they otherwise would need to spend time with. So that is where you get into this value prop at the integrated system level that they see very clearly and we’re happy to help drive.

[Joanne Wuensch, BMO]

Thank you, just a second question. If I heard you right in 2020 we should start thinking about you moving towards profitability. Walk me through peak gross margins and when do you think you will be cash flow breakeven? Thank you.

[Matthew Garrett]

Well I am not sure, we’re quite ready to say a particular quarter or particular period but I do believe that on current kind of organic look at the business there is reason to believe that we could be both EBITDA and OpEx breakeven, at some point during the year 2020. That said, without understanding the top end of our sales force hiring, additional investment that we want to make in the business that as we sit here today, we don't see. I'm not ready to call a particular time I’m just saying that we believe given where we are today that that is absolutely achievable. The other thing that I’ve said recently is if you look at our growth rate, and assuming that you're going to continue to have benchmark growth, it would only take us one to two quarters max if we were to slow that OpEx growth significantly, which would mean pulling back on some of the levers that we think are important to top-line growth, but nevertheless would be able to do that in such a way that we would see cash flow breakeven and/or EBITDA positive numbers very, very quickly. So that was my point of saying we keep an eye on our spend and as long as we feel that the overall growth rates of OpEx continue to decrease as we achieve what we think is our top-line guidance that we can easily foresee that ability in 2020.

[Operator]

Thank you. Our following question comes from Suraj Kalia with Northland Securities. Your line is now open.

[Suraj Kalia, Northland Securities]

So Kevin and Matt maybe I can -- if you could help us with a little additional granularity and on the metrics. Can you tell us what is the average new accounts being opened per tenured rep and per new rep?

[Kevin King, CEO]

Suraj, we don’t really give that level of detail out.

[Suraj Kalia, Northland Securities]

Okay. And in terms of the OpEx, Kevin again, and at least from the commentary and from what I understand, you'll recognize the surplus component of finalizing the ECG readout in COGS, clinical trials are represented in the SG&A component. Can you walk us through the SG&A component? I want to piggyback one of the earlier questions about the OpEx, the SG&A, even if I look at the FY '19 guidance, still seems quite high. What else is included, is it higher commissions, is it incentives, any color there would be great?

[Kevin King, CEO]

Yes. So the question on clinical trial costs. When we run a trial, is that not taken out of OpEx. Am I mistaken?

[Matthew Garrett]

No, it's OpEx.

[Kevin King, CEO]

It's OpEx. Okay. So that's in our SG&A, right.

[Matthew Garrett]

Correct.

[Kevin King, CEO]

Okay. And all of our cost of our service is advice and data curation and all of the other associated are in course. So Suraj, I don't know how to answer your question. It's seems that you're asking for what's in SG&A?

[Suraj Kalia, Northland Securities]

No, what I'm asking is, you have currently 110 reps, let's say, X amount is spent on clinical trials, which is embedded in the SG&A. You're going to add a 20, 30 additional reps this year. Trying to triangulate, okay, this is how much the SG&A has increased, this is why it's increasing. Even if I look at a tenured rep generating $2.5 million revenues annualized, some of the datas -- on -- I would love to get some additional color. Okay, we're spending $20 million in clinical trials. These many reps are -- we -- from a modeling perspective, we can back out, okay, this much is in -- the reps are being paid, this is their commission. Just trying to put the nuts and bolts together, and eventually see okay, this much time down the line, on a normalized basis, the Company is going to reach profitability or where you think things are going to settle down.

[Kevin King, CEO]

Yes. Well, Suraj, I mean I think I did about as much detail as we've ever given on profitability with my previous comments on 2020. And we don't really give out the level of detail that you are requesting as it relates to '19. I'll share this with you the way that we look at it. We've seen this improvement productivity obviously in gross margin. We've seen it as it relates to our sales reps. Where we're also starting to see it is in that infrastructure about supporting the sales reps, and we're also seeing a diminishing growth and from a run rate basis on some of the items, we've talked about throughout 2018 such as sales commissions, as well as stock compensation and bad debt expense.

We don't expect those to continue to grow. So when we say that we grew year-over-year OpEx of 44%, which includes the $4 million of kind of one-time accruals, if you take that out, you're actually less than I think in the low 30%s. We're guiding toward below 30% next year. That growth on a run rate basis, coming out of Q4, would be mostly related to the new sales headcount and a continued investment that we're making in the support structure around that team. And I think that's probably about as much detail that we go into.

[Operator]

Thank you. Ladies and gentlemen, I'm not showing any further questions at this time. I would now like to turn the call back to Kevin King, the CEO for any closing remarks.

[Kevin King, CEO]

Thanks everyone for joining our call today. We look forward to talking with you at the end of the first quarter on further updates. All of our material is on our iRhythm website for you to review. We look forward to talking to you soon. Thanks.

[Operator]

Ladies and gentlemen. Thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a great day.