Kim Blickenstaff
Analyst · Stifel. Your question, please
Thanks, Susan. And welcome everyone to today’s call. Joining me today is Leigh Vosseller, our Chief Financial Officer. 2018 is off to a strong start with record first quarter sales and meaningful operational progress throughout our business. In addition, we continue to advance our new products under development, including our PMA submission to the FDA in February for the t:slim X2 with Basal-IQ which features a predictive low glucose suspend algorithm. Overall, I am proud that the positive momentum from the end of 2017 has continued, further strengthening our confidence that we’ll achieve our goals in 2018. Starting with sales. Two of the key strategic initiatives we executed on in 2017, the launch of the t:slim X2 with Dexcom G5 integration and the launch of our custom t:lock infusion sets continued to drive our top line growth in the first quarter. As we’ve discussed in the past, these initiatives along with current Tandem customers becoming eligible for insurance reimbursement and choosing to renew with our insulin pumps, once again, served as an inflection point in our business model at the end of last year. So, these were not one-time events; we continue to benefit from them in Q1; and we expect, we will continue to do so moving forward as well. Consistent with what we saw in Q4, about half of our organic customers reported being new to pump therapy, suggesting strength in the overall pump market. Of the customers who report converting from another manufacturer, we were pleased to continue to see a high number of former Medtronic and Animas customers choose the t:slim X2. Prior to the Animas October announcement that they were exiting the market, our shipments to former Animas customers as a percent of our business were in the low teens. In December, it grew to more than 20% of our shipments and it remains at this level during the first quarter. This increase in Animas conversions, even with Medtronic being designated as a preferred pump partner emphasizes the importance of people with diabetes, having a choice in their insulin pump therapy management, and that diabetes is not a one size fits all solution. At Tandem, we work hard to offer the diabetes community flexible, differentiated options for therapy management. As a result, we now have the updatable t:slim X2 platform and have found that it's the perfect choice for the vast majority of our customers. At the same time, demand for our t:flex insulin pump, which features the 480-unit insulin cartilage for people with greater insulin needs, has not been enough to support its continued development, and we've decided to discontinue new pump sales at the end of the second quarter. For comparison to the first quarter, we shipped less than 100 t:flex plus compared to more than 4,000 t:slim X2 pumps. Our current t:flex customers can rest assured however that their pumps will remain fully supported. We will continue manufacturing t:flex cartridges all compatible infusion sets, so they will have access to supplies and to the same 24/7 customer support for the time left in their warranties. From an R&D perspective, we are evaluating other potential solutions for people with greater insulin needs such as insulin concentrates and we’ll keep everyone informed, should these initiatives progress. Where our near term product development focus lies is bringing our automated insulin delivery or AID products to the diabetes community. As we've discussed in the past, the three critical components of an AID system are an insulin pump, a continuous glucose monitor sensor and an algorithm. An algorithm can only be as good as the information that is provided to by the CGM. Dexcom has offered best-in-class CGM technology for some time, and they've raised the bar once again with the recent FDA approval of their G6 sensor that will offer people with diabetes a number of important advantages including no fingersticks and acetaminophen blocking. The sensor also received approval for integrated interoperability or iCGM which is expected to streamline the regulatory process when used with other connected devices. Big congratulations to our San Diego partners, the Dexcom for this accomplishment. The G6 approval is a win for the diabetes community and strengths the overall systems that we plan to integrate with our sensors. As we look to what this means for Tandem's products and development, starting with the t:slim X2 with Basal-IQ. This system is designed to suspend insulin when low blood glucose is predicted and automatically resume insulin delivery when glucose levels begin to rise. In February, we submitted a PMA to the FDA, which included previously announced positive pivotal study data that showed the system achieved the primary outcome of reducing times spent in hypoglycemia by 31% compared to sensor-augmented pump therapy alone. We were thrilled to see these clinical results and equally important to us was the feedback from study participants that the system is easy to use and they have high level of confidence using it without a significant training burden to get started. As we shared in the past, this supports the usability data we presented at the Diabetes Technology Meeting in the fourth quarter, which demonstrated a 99% success rate among study participants who performed a series of critical tests using the Basal-IQ system after initial computer-based training. We believe ease of the use of our system will give us a competitive advantage when compared to other systems that are currently available. Our t:slim X2 with Basal-IQ pivotal study use Dexcom's G5 sensor. However, based on Dexcom's recent G6 approval and iCGM designation, we've been speaking with the FDA to outline the path for us to offer t:slim X2 with Basal-IQ and iCGM compatibility. This would allow for our Basal-IQ system to be used with Dexcom’s G6 sensors. Due to competitive reasons, we won’t be outlining the regulatory path details, but we remain confident on our goals to launch the t:slim X2 with Basal-IQ this summer with the G5 sensor and we’re actively working on adding iCGM or G6 sensor compatibility shortly thereafter. Our ability to have this flexibility and adapt to the pace of our partner’s innovation reflects the power of the Tandem device updater. It’s a feature that no other insulin pump company offers today and continues to allow us to stand out compared to the competition. As we previously announced, all new features approved of the t:slim X2 by the FDA in 2018, will be made available to in-warranty users for no cost. Based on our current development activities, we expect these features will include both our Basal-IQ software and the iCGM or G6 compatibility. We’re also making great progress with our second generation automated insulin delivery system with the t:slim X2 with Control IQ. Also designed as a software update, t:slim X2 users, the system increases or decreases Basal insulin to minimize hyper -- or hypoglycemia and improve the user’s time spent within a targeted glycemic range. The hybrid closed loop product has all been designed to leapfrog competing products by providing automated correction boluses which we believe will bring additional benefits to our customers. The system was designed to utilize Dexcom’s G6 sensor values and AID technology that we licensed from TypeZero and we’ll be pursuing the approval of iCGM compatibility as a part of this submission. As a reminder, we are participating in the International Diabetes Closed Loop Trial and the pivotal trail portion is anticipated to commence this quarter. Accordingly, we believe we’re on track to file our modular PMA submission to the FDA in the second half of this year and our goal is to launch the t:slim X2 with Control IQ including iCGM compatibility in the first half of 2019, following FDA review and approval. Turning to another of our growth initiatives, we’re on track and actively preparing to commence sales outside of the U.S. in the second half of 2018. We announced the filing of our medical device application in Canada in the first quarter and we anticipate receiving our CE Mark this quarter. As a reminder, we expect to operate direct sales in clinical operations in Canada, but primarily leverage our other domestic customer support resources. For other geographies, we plan to utilize distributors with mostly existing infrastructure and resources and have announced some of these key relationships in the past few weeks. We welcome these partners on Australia, New Zealand, Italy and Scandinavia. While there’s significant activity internally comparing to offer the t:slim X2 outside of the United States, we continue to prioritize our efforts within the U.S. and have modest expectations for the contribution from international sales in 2018, but believe it’s strategically important to position us for 2019 and beyond. Overall, it’s been busy start to the year and I’m very pleased with the progress we’ve made across all of the Company’s initiatives in the first quarter. I credit these accomplishments to the hard work, passion and dedication of our employees. I will now turn the call over to Leigh to further discuss our results for the quarter and our financial guidance. Leigh?