Leslie Trigg
Analyst · Goldman Sachs
Thanks, Lynn. Good afternoon, everybody, and thank you for joining us to review our first quarter 2021 results. Since our last update in March, the Outset team has continued to execute exceptionally well across all of our key strategic initiatives. We outperformed on revenue, secured new console orders across care settings and made substantial progress operationally. For the first quarter, we reported $22.9 million in total revenue, representing 219% growth year-over-year and 33% growth sequentially. This outperformance, relative to our expectations, was driven primarily by increased product volume as well as higher ASPs. While new customer acquisition is important, a leading indicator we watch just as closely is whether our existing customers expand their use of Tablo to other facilities within their network. This metric provides tangible validation of Tablo's value in lowering cost and increasing operating efficiencies. In the first quarter, more than 75% of the consoles ordered were for shipment to new sites within existing customer networks. Customers continue to cite positive experiences as well as an appreciation for Tablo's economic value and ease of use as factors that are driving their decision to purchase additional consoles and expand to new locations. In terms of new customers, we added several health systems during the quarter and are currently projecting that we will have signed agreements with seven of the top eight national health systems as well as a third of the top 100 regional health systems by the end of this year. Achieving these goals will be a testament to the strength of our entire commercial organization market receptivity to Tablo and importantly, our future growth prospects. As more prominent health systems adopt and expand with Tablo, we're starting to see a greater number of independent publications and abstracts. For example, Q1 saw clinical abstracts written and submitted to scientific conferences from UPMC, the University of New Mexico and HCA. These abstracts reported on Tablo's success treating high acuity patients and cost reduction. The St. Mark's HCA abstract, for example, reported a $550 per treatment cost savings with Tablo. As we've outlined in the past, we include both acute and subacute facilities in our definition of the acute market. Within the subacute market, we're focused on penetrating both long-term acute care facilities known as LTAC as well as skilled nursing facilities. For these customers, the Tablo value proposition is similar, supplies and labor cost reduction along with operating efficiency and clinical versatility. Our sales team has successfully communicated these advantages to LTACs across the country. And in fact, Tablo is now used by three of the four largest LTAC providers. While we still have considerable runway, both in terms of expansion across our LTAC customers and new customer acquisition, we're pleased by the adoption uptake so far. With our installed base growing in the acute and subacute markets, we are increasingly confident that our value proposition is resonating quickly following console deployment. We view this early momentum as critical and expect it to continue to build as key stakeholders experience the unparalleled benefits of Tablo's clinical versatility, point-of-care mobility, data-rich simplicity and economic advantages. As we move to expand our footprint, we have also continued to grow our home population. In the first quarter, we signed master contracts with four new home customers, which in part led to a 50% sequential increase in home console orders. This early traction helps fuel our anticipated home growth trajectory and puts us in a good position to meet our 2021 home goals. The majority of our new home contracts are with progressive, innovative customers spanning both health systems and dialysis care providers. One of our notable new customers, for example, is focused on enabling health systems to identify chronic kidney disease earlier and manage patients all the way to the home. In this model, Tablo is their preferred home dialysis technology, while the services provider supports the patient journey from the hospital to the home for the health system. In other cases, the health system itself is standing up and managing its own home dialysis program. In fact, currently a third of the health systems in our pipeline are interested in beginning home programs. In both models, Tablo is an important enabling technology. From a provider's perspective, we believe that as we collect and present real-world evidence, Tablo's value proposition at home will become increasingly tangible. To-date, patient data from those at home remains exceptional. We continue to see highly differentiated patient training times on Tablo, consistently two weeks or less compared to the four to six weeks it typically takes patients to learn the incumbent device. Additionally, we have seen much lower patient attrition. For example, published data on the incumbent device documents a training dropout rate that is 60% higher than seen on Tablo to-date. Moreover, while still very early and on a small number of patients, we have not had a patient choose to come off Tablo once they started at home. As our patient population grows, we certainly expect the dropout rate to increase, but it's a good start and one that we are very proud of attaining. We continue to believe that these two metrics, training time and dropout rate, are the most vital because they represent the biggest historical problems that have prevented HHD growth in the past, onerous training and high attrition. On a qualitative level, we get to see the impact Tablo is having on patients' lives every day. We recently had a patient go back to work and another report that he is now able to cycle 10 to 15 miles per day even on the days he dialysis. These are the stories that really motivate us the most and represent the impact we intend to have on the lives of patients. We look forward to continuing to deliver on our vision to transform dialysis for patients into a tech-enabled journey with seamless activation, training and retention, all driven by digital marketing and support features. As orders for Tablo build, our supply chain and manufacturing teams have continued to lift production capacity while maintaining an exceptional level of quality and focus on our cost reduction activities, both of which are vital to our long-term success. Our new facility in Tijuana, Mexico, which incorporates a state-of-the-art cloud-based manufacturing and documentation system produced 165 consoles in Q1 ahead of plan. This outperformance was the primary driver of slightly better-than-forecasted gross profit, leading to our second quarter of positive gross margin. The factory continues to ramp, and in April alone, the team manufactured over 100 consoles. With production increasing, we remain well positioned to satisfy our forecasted shift schedule fully from the new manufacturing facility in the second half of this year. Additionally, we submitted our 510(k) application to FDA as expected in March to enable our new contract manufacturing partner to produce Tablo cartridges. The submission puts us on track to shift the majority of production from Asia to Mexico later this year and to see the anticipated benefit from the related cost reduction in the second half of 2021, assuming FDA clearance within the expected timeframe. Looking ahead, we remain focused on achieving three critical objectives through 2021. First, driving growth in the acute market by expanding more deeply within our current customer base and signing new agreements with regional and national health systems, second, accelerating home patient adoption to capture incremental user data, bolster customer relationships and provide a foundation for significant growth in 2022, while working to ensure an exceptional Tablo home experience for patients and their families. And third, continuing to focus on increasing manufacturing output and cost reduction activities to drive gross margin expansion. With the benefit of our recent follow-on offering, we are more confident than ever in our ability to drive the adoption of Tablo across multiple care settings. The proceeds will help us fund revenue growth, which is tracking above our internal estimates for less than a year ago. Additionally, we are moving forward with various home, R&D, international and data analytics initiatives designed to drive durable long-term growth and profitability. In summary, our first quarter was marked by strong revenue performance, continued operational execution and substantial progress across our strategic initiatives. We see demand for Tablo accelerating across the acute and subacute care settings with a growing number of providers uptaking Tablo for home as well. At the same time, we remain on track with manufacturing and cost reduction initiatives. With interest in Tablo and clear visibility on the timing of console placements, we are confident in our positioning for consistent strong performance in 2021 and beyond. And so, with that I'll now turn the call over to Rebecca to review our financials and provide more granularity on our expectations and key drivers for the remainder of 2021.