Kim Blickenstaff
Analyst · Bank of America. Your line is open
Thanks, Susan. And welcome everyone to today's call. Joining me is Leigh Vosseller, our Chief Financial Officer. It's been a tremendous first half of 2018. We began the year with big aspirations to grow product development and operational progress, and I'm proud that in the first 2 quarters we delivered on all fronts by meeting or exceeding our goals throughout the business. Some highlights of Q2 include: our achievement of 60% year-over-year sales growth, which is a third consecutive quarter of record sales, our 6 points year-over-year gross margin improvement, the FDA approval of the t:slim X2 with Basal-IQ technology, our first automated insulin delivery algorithm, and the earlier than anticipated designation as compatible with integrated continuous glucose monitoring devices, or iCGM. The initiation of the pivotal trial for t:slim X2 with Control IQ technology, featuring the algorithm we license from TypeZero; and the receipt of CE Mark approval and the significant efforts to prepare for the international launch in the second half of the year. The positive momentum we entered 2018 with has continued to build, primarily due to the high demand for the t:slim X2 pump. As included in today's press release, our increase in sales guidance reflects our success in the first 2 quarters and our confidence that we will deliver continued growth. In looking where our business came from the second quarter, 2 things stood out. First is that we continue to have great success in attracting people using multiple daily injections to pump therapy. Expanding the number of people using insulin pumps has always been a strategic goal for the company, and having about half our new customer report being new to pump therapy is great evidence of our continued achievement of this goal. Second is that we saw a notable increase from the number of new customers who were choosing to convert from a Medtronic pump to the t:slim X2. If that, this quarter, we saw twice as many Medtronic conversions and twice as many Animas conversions compared to Q2 of last year. In volume, Animas conversions were similar to what we saw in Q1. Our success in both expanding the market and capturing market share is a sign of the overall insulin pump market is healthy and that Tandem is continuing to emerge as a significant player in the space. Now owning or we continuing to see more meaningful growth for customer adoption, but something I'm particularly proud of is that our customers reported a high rate of satisfaction with our pumps. In the second quarter, we completed our annual customer survey, and the feedback we receive is extremely important as it helps guide our continuous improvement efforts, and is also an indicator of our customers' renewal intentions. Renewals continued to be a key strategic area of focus for us, and we shipped more than twice as many of renewal pumps in the second quarter compared to Q2 last year. We anticipate positive momentum we've experienced these few quarters will continue as Q3 is already off to a strong start. An important driver is our upcoming launch to the t:slim X2 with Basal-IQ technology, which is designed to help reduce the frequency and duration of low-glucose events or hypoglycemia. We are seeing great enthusiasm of the diabetes community, not only about the availability of our predictive low-glucose spend, or PLGS feature on our pump, but also on our decision to offer this feature in-warranty t:slim X2 users in the United States at no cost. As a reminder, our t:slim X2 with Basal-IQ technology is designed to look 30 minutes into the future to predict where glucose levels are heading. It then suspends insulin delivery when low glucose is predicted and automatically resumes insulin delivery once glucose levels begin to rise. Our pivotal clinical trial demonstrated a 31% relative reduction in time spent below 70 mg/dL and using Basal-IQ with no rebound hypoglycemia, compared to a CGM enabled insulin pump without this feature. We believe this data is compelling and we are actively sharing it with payers as a part of our larger strategy to pursue more direct contracts. Our t:slim X2 is also the first insulin pump designated as compatible with iCGM devices. This is significant as we're now able to launch this pump ahead of our original time line with Dexcom's G6 CGM, which requires no fingersticks for calibration or diabetes treatment decisions. To put this in perspective, the compatibility of Dexcom's G6 means that our pump users can have the most accurate sensor available, and yet also eliminate at least 40 to 50 fingersticks per week or more than 2,000 fingersticks over the course of a single year. We expect this to translate into measurable quality of life improvement, not to mention cost reduction for Tandem customers. We are on track to begin shipping Basel IQ pumps in August, and we’ll concurrently be rolling out the software to existing t:slim X2 to customers. With only one additional screen for users to learn, this pump is so easy to use that training on the new feature is typically able to be done in 30 to 45 minutes through a web-based training module. Following launch of Basal-IQ, the next software update we are working on for the t:slim X2 with Control-IQ, our second generation automated insulin delivery system. As a reminder, we intend for the system to utilize Dexcom’s iCGM or G6 sensor values and AID technology that we licensed from TypeZero. Control-IQ was designed to increase or decrease basal insulin to minimize hyper and hypoglycemia and improve the user's time spent within the targeted glycemic range. It is also been designed for leapfrog competing products by providing automated correction boluses, which we believe will bring additional benefits to our customers. We are working with Dexcom and TypeZero on the integration of our technologies into the Clinical Acceptance of the Artificial Pancreas or DCLP3 portion of the IDCL trial. Enrollment began in June and is progressing well. We’ll be using data from this study and our modular PMA submission to the FDA, the first module, of which we plan to submit via FDA in September. While the study won’t conclude until next year, the benefit of modular submission is that it allows the agency to review at sections. This will hopefully resolve in a more expedited review process compared to waiting until all the data is available for more traditional PMA submission. Our goal is to launch t:slim X2 with Control-IQ in the summer of 2019, subject to FDA approval. Our automated insulin delivery efforts are intended to provide customers with systems that can improve their therapy management experience and ultimately their clinical outcomes. Launching G5 integration last year, Basal IQ this year and our anticipated launch to Control-IQ next year is a remarkable cadence to our product releases. It not only allows us to deliver exciting features to our new customers, but through the use of the Tandem Device Updater, we are also able to offer continuing innovation for existing in-warranty t:slim X2 customers, a capability offered by no other insulin pump company. Turning to a longer-term growth driver for the company. We are making excellent progress on our preparation to launch t:slim X2 outside of the United States in the upcoming months. Most notable was our receipt of CE Mark at the end of April and our active contracting efforts. Today, we have entered into agreements with independent distributors for markets in Australia, New Zealand, Italy, Scandinavia, South Africa, Spain and the United Kingdom. While there isn’t great data on the exact number of people of type 1 diabetes by country, we know it’s an underpenetrated market globally. With our history of about half of our customers converting to multiple daily injections and the fact that we strategically chosen countries and distributors with meaningful Animas representation, we believe our international expansion will be modest this year and a meaningful growth driver over the next few years. We’ll be providing additional color on what we think is opportunity represents in the future closer to our upcoming international launch. We’re on track amidst OUS shipments this year, and we’ll keep you updated with these efforts, along with the happenings of our business as we continue to make progress. With so many great things that happening at the company, we’re planning to host an Institutional Investor and Analyst day here in San Diego on September 25th at which we will discuss more about our automated insulin delivery algorithms, our international plans and the longer-term strategy for the company. September 25th is the day-off between the DCT Cardiology Conference taking place in San Diego and the NASS spine conference taking place in Los Angeles. So we welcome any med tech folks to these conferences or anyone who would like to make the trip to San Diego to join us. The event will also be webcast. Additional details on registration information are available through the Investor Center of our website. I’ll now turn the call over to Leigh to further discuss our results for the quarter and updated guidance for the year.