Kevin King
Analyst · Morgan Stanley. Please go ahead
Thanks, Lynn. Good afternoon, and thanks for joining us. 2019 is off to a very strong start. We achieve first quarter year-over-year revenue growth of 54% reaching $47.2 million. Q1 gross margins increased by 3.4 points to 75.2%. Our business continues to strengthen on many fronts driven by accelerated adoption of our highly differentiated Zio platform with an existing and new accounts particularly and targeted large hospital networks. Zio has proven clinical superiority. The completeness of our service combined with our increased organizational strength, give us the confidence to increase our 2019 revenue guidance to $206 million to $211 million up from $201 million to $206 million, which represents annual growth of 40% to 44%. The three primary components that remain key to our short and long-term growth strategy are, sales team expansion and continued productivity improvements, increase market penetration with our single Zio platform strategy and expanding our addressable market into new indications. I’d like to take the next few minutes to highlight our progress on each of these objectives as well as some of our near-term catalysts and then I’ll turn the call over to Matt for a detailed financial review of the quarter and additional annual guidance. Starting with our commercial organization, salesforce expansion continues to be a key contributor to our sustained growth rates. Over the past several years, we have successfully increased the size of our sales channel by 20 to 30 high quality reps per year, while increasing the productivity of our most tenured reps. As mentioned on our last call, our 2019 goal is to add a similar number of sales positions bringing our total sales rep head count to 130 to 140 reps. We have also created a number of regional sales manager positions to support the increased headcount. Similar to our hiring trend in 2018, we plan to have the majority of these new hires in place by the end of the first half of this year. Importantly, we will continue to expand our commercial team to whatever cost effect of size is required to capture the full and untapped market potential that lies in front of us. Turning to account penetration, we continue to see adoption in new and existing accounts. The proven superiority and completeness of our Zio platform enables accounts to measurably diagnose more patients in less time with fewer unnecessary repeat tests and at lower cost and with fewer resources compare to other approaches. Zio AT a newer component of our platform strategy addresses our – expands our addressable market into a previously unaddressed segment of the market provides our customers with a more complete solution on a single platform. We are increasingly encouraged by Zio AT’s impact with on our early customer sites. As we’ve discussed in prior earnings call, the payer landscape for this market segment remains challenging as measured by the number of health plans with no or negative coverage policies for the technology, the percentage of plans that have a narrow set of indications for use and a relatively higher bar for medical necessity including sales first line testing. These challenges played a key role in our decision to implement a phased rollout of Zio AT. I’m pleased that we have now achieved a threshold of AT contracting that allows us to more rapidly expands Zio AT into the market in the second half of this year. At the Heart Rhythm Society Meeting this week in San Francisco, we plan to more broadly unveil our Zio AT. Clinical evidence remains a key pillar not only in our discussions with payers, but also as a driver for competitive differentiation and market adoption. And important perspective randomized study was published in the February 11th online issue of the Journal of Interventional Cardiac Electrophysiology, the diagnostic capabilities of our Zio service was compared against the event monitor as well as two other ambulatory ECG monitoring technologies including another patch based monitor. To study design was unbiased in that the performance of each of the monitors was compared against an implanted pacemaker which is widely accepted as the goal standard for Atrial Fibrillation detection. Results demonstrated not only that Zio was significantly more accurate in detecting AFib than the event monitor, but also that Zio was the most accurate of all ECG monitoring modalities tested with an r squared value of 0.999 compared to the gold standard pacemaker. The statistical probability of having a correct AF diagnosis as measured by the odds of a collect diagnosis reveal that Zio was 12.3 times higher than the event monitor, six times more likely to accurately detect AF compared to the [indiscernible] monitor and twice as likely to accurately detect AF compared to the CAM monitor. Studies such as discontinued to demonstrate the superior accuracy of our Zio service and its potential to positively impact patient treatment decisions compared to legacy monitoring technologies and new patch based offerings. Sign on AF remains our other key market expansion priority. This is a population of 10 million plus patients who are undiagnosed with AF, but have risk factors such as age, hypertension and diabetes. We’ve published last year the mSToPS study that demonstrated the utility of Zio in diagnosing AF in this asymptomatic population. And at the annual meeting of the American College of Cardiology last month, a poster was presented on one year health resource utilization from the mSToPS trial, which show that patients who are diagnosed with AF in the Zio monitored group had a significantly lower rate of hospitalizations and emergency room visits. Then the non-monitored controlled group. Evidence such as just to build the case for targeted detection of AF by Zio in the asymptomatic population. In 2020, we expect the three year outcome for health care utilization data from mSToPS to be published, which will be an important data point for clinicians and payers and opening up this market. Finally, I’d like to discuss reimbursement. During the last quarter, many opinions and perspectives surfaced in the media related to the reimbursement landscape and its impact on Zio XT. Now that we are able to comment on it, I will discuss the current status, how we see the process unfolding and our views on any potential reimbursement change. It’s important to start this discussion by knowing that Zio XT has rapidly become a standard of care for long-term continuous ambulatory cardiac monitoring across the country. Our services has covered and reimbursed by nearly all national, regional and government health plans. Medicare accounted for about 27% of our total sales in Q1. The mechanism by which we report our services to these health plans and receive payment is to a category three CPT code, which is by definition a temporary billing code established for new technologies. In my case of our Zio service, a new long-term continuous ambulatory monitoring code was established in brought forth by the ACC to the American Medical Association in close partnership with iRhythm in 2012. In 2017, the ACC again in close partnership with iRhythm successfully brought forth the code for renewal. Since then, we have continued to work closely. After both use data and published clinical evidence is gathered over time, eventually the temporary code can become a permanent code or what is called a category one code. The process to convert a code from category three to category one is governed by the American Medical Association or AMA and CMS or Medicare. The way the process is designed. A physician specialty society, which has an official advisory seat on the CPT committees, sponsors the code conversion, presents the data and clinical evidence to the AMA committees in carriers to code through the process. In our case, the specialty society who will sponsor our code is the American College of Cardiology or the ACC. Importantly, we have been collaborating with ACC and what is termed a CPT code change application, which is necessary to convert the code from a category three to a category one status. In order for the ACC to effectively sponsor the code application it needs what they term in industry advisor and iRhythm is the primary industry advisor as the leader in the category. As ACC has a formal and official seat within the AMA CPT process, it is very important that we as the primary provider of the service be in alignment with them and we are. The work we’ve been engaged in with ACC involves a review of all available clinical literature, of which Zio XT is the primary monitoring technology involved in nearly all of these studies to properly code – to code change application. This code change application is based on physician usage and clinical studies. Importantly, iRhythm has invested heavily in creating substantive clinical evidence in this category and also represents more than 95% of the volume of tests that utilize the current long-term continuous monitoring code. We are very pleased with our interactions with the ACC to date and view them as a key partner in this important process. As we’ve previously discussed, if any changes take effect, it is expected to occur no earlier than 2021 and no later than 2022. Our preference is that this occurs sooner rather than later and we’re working with the medical societies towards a 2021 change. However, the exact timing will be dictated by the calendar per submission of CPT applications. We should know later in the year, whether our code change application will be considered for a 2021 calendar cycle. While the general code change application process is consistent, the specific pathway to a pricing outcome is unique to each code, because physician usage and clinical studies dictate the definition, which is different for each code. Other examples are useful to aid in general understanding, but because each pathway has unique, one cannot assume an outcome for one code based on solely on other experiences, any sub-supposition is truly speculative. Of course, there are examples of category three to category one code changes were a final pricing went up or down compared to their category three price. This is understandable since a category three code is established, when services new and experience is low or nonexistent. It is only after industry and physicians gain experience that the technology can be better defined and through that change in definition, the pricing may go up or down on a relative basis. With this in mind, I want to reiterate our confidence in the value of our Zio service and that we do not currently anticipate of substantial change to our Medicare reimbursement rate during this process. The value in differentiating on our Zio XT service has been proven in over 30 peer review clinical studies, including those which directly compare our service to legacy Holter monitor and event monitor technologies. We believe that this differentiation is clear in the minds of the medical societies and payers, the two key constituents involved in any reimbursement decision. Our Zio XT service has also been rigorously and independently valued by hundreds of commercial health plans with whom we have established in network contracts, as well as our local Medicare administrative contractor. These health plans have considered our published clinical evidence, the clinical utility and healthy economic benefits of our Zio service along with our proprietary analysis methodology to conclude that our Zio service is appropriately valued. We expect the process and outcome for establishing a national Medicare rate when the code moves to a permanent status to be no different. I want to note, however, that we maybe limited in the frequency of updates and availability of new information we share, because interested parties involved in the coaching process are legally bound by non-disclosure and confidentiality agreements. That said, we are confident in our path forward and it will make every effort to update you to the extent we are able to disclose new inflammation. In summary, we have confidence in our highly competitive positioning and differentiation, including Zio’s proven clinical superiority and the completeness of a platform that routinely creates meaningful value for our customers, large and small. We look forward to continuing the success in 2019. And with that, I’d like to turn it over to Matt Garrett, our CFO for a review of the first quarter financial results and guidance for 2019. Matt?