Kim Blickenstaff
Analyst · Piper Jaffrey. Your question please
Thank you, Susan, hello everyone and thank you for joining us on today's call. With me today is John Cajigas, our Chief Financial Officer. We're coming out of our first quarter performance with great confidence about our ability to achieve our key goals for the remainder of the year both operationally and commercially. Although it remains a highly competitive environment, we showed strength in our sales. We also continue to provide our customers with number one rated support and just as importantly we made meaningful progress on our automated insulin delivery pipeline. Across the company we are focused on furthering this momentum in 2017 and closely monitoring our progress toward all of our key goals. The competitive headwinds we expected in the first half of this year are there as anticipated but the reasons customer choose Tandem over the competition is for our best-in-class pump platform and the emphasis our company puts on customer care, and that's where we will continue to focus our time and attention. We understand that our customers have choices and that customers who chooses Tandem product rely on us for the long-term care and it is a responsibility we do not take lightly. To the contrary, we take great pride in the high customer satisfaction scores and we intend to continue to deliver on our new products and development and validate the great across that our customers have placed in us. As a reminder, in September of last year we launched the t:slim X2 pump, our next generation flagship product. It is unique as it brings people with diabetes all the features and benefits that made Tandem fastest-growing pump company while offering an ability like no other pump available today. It's the only insulin pump that can be updated by a customer to add new features using their personal computer. This tool the Tandem Device Updater is revolutionary for our industry because as a company that is constantly innovating. It is designed for us to be able to bring new features to our customers as they are approved by the FDA. The purchasing trends that we saw on the first quarter suggest that this differentiated product offering is helping us successfully compete against Medtronic's launch of their 630G and their 670G pumps. As we discussed in the past, Medtronic announced the approval of both their pumps around the same time we were launching our t:slim X2. As a result we experienced pause in the market which is something we've seen historically during competitive launches as customers look to evaluate the new pump offerings prior to making a decision. But even with the absence of a full-scale launch with the 670G, we found that people with diabetes particularly people using multiple daily injection are beginning to move forward with their purchasing decisions and that the market has slowly begun to unfreeze. The 630G began shipping in the fourth quarter of last year and we're increasingly seeing reports and hearing feedback from customers and healthcare providers who are disappointed in Medtronic's new platform. The weaknesses of the Medtronic product become very real once customers and healthcare providers see and use the product firsthand, especially if they ever seen a Tandem pump. Concerns about 670G have centered around the new interface being difficult to learn, train and use, as well as on the form factor of the pump, namely that is still antiquated and has increased in size compared to Medtronic's historical platform. This is where the t:slim X2 shines in comparison. The 670G is more than 60% larger than the t:slim X2, while the t:slim X2 offers the same 300 unit capacity in addition to modern features such as Bluetooth connectivity, a rechargeable battery that in today's world consumers have come to expect. Our display which is one third larger than the 670G screen provides a convenient and easy-to-use menus of a touch screen similar to today's consumer friendly mobile devices. In addition, we’re partnering with Dexcom for the continuous glucose monitoring technology, the most accurate sensor available. The real-world accuracy of Medtronic's new sensor which is what powers their automated insulin delivery algorithm remains to be seen. We do know that Dexcom CGM sensors superior as the only device allows a person to make therapy decisions without pricking their finger and requires half the calibrations of Medtronic. So the users of the 670G are not able to make dosing decisions using their sensor, this means that user will likely still need 5 to 7 finger sticks per day to use the pump in a real-world setting. In addition to patient burden, this also adds additional cost of extra meters drips to the rest of the system. We also know that the 670G is not indicated for use by anyone below the age of 14 and that Medtronic determined that may not be safe for children under 7. It's not clear to us that Medtronic is going out a way to make these facts apparent to customers or healthcare provider, and we believe it is essential that the marketplace understands what the 670G is and what is not. By highlighting the core differentiated features of the t:slim X2, we’re able to capitalize on the shortcomings of competitive products. Suffice it to say that we feel confident in our ability to compete pump platform versus pump platform against Medtronic. And the time when we would be able to offer superior automated insulin system is fast approaching. Historically about half of our customers have reported being new to pump therapy and half of them reported converting from a competitors pump. In the first quarter, nearly 60% of our customers reported being new to pump therapy from multiple daily injection. At among customers switching from competitors pump, we continue to see the largest percentage converting from Medtronic all by anonymous. This is encouraging because we are demonstrating our ability to continue attracting people from MDI. As people converting from another pump take time to evaluate their decision, we are getting closer to FDA approval of our t:slim X2 with G5 integration, which we believe will strengthen our competitive positioning even further. If you look back at our first quarter shipments from 2016, the majority were key slim G4 pumps that are integrated with Dexcom's G4 continuous glucose monitoring sensor. This wasn’t surprising because independent survey show that CGM integration has been and continues to be the top feature impacting a customer's purchasing decision across all durable insulin pumps. That being said, the majority of our customers do not actively use CGM but maybe considering it or want the optionality to use it in the future. The t:slim X2 is the only pump that provides this flexibility without asking customers to make trade-offs such as increasing the pump size and complexity to buy for this feature. Since we announced the launch of the t:slim X2, it quickly became the vast majority of our pump shipments. This trend was encouraging as it was a recognition from our customers that the power of the Tandem Device Updater is game changing. We submitted the PMA supplement for the t:slim X2 with G5 integration to the FDA earlier this year, and have been very pleased with the interactive nature of our review. Our approval is always at the discretion of the FDA we are preparing to launch this summer. As a reminder subject, the FDA approval we expect to offer G5 sensor integration as a software update free of charge for more than 10,000 t:slim X2 customers to the Tandem Device Updater. Our customers won't need to wait months or years to gain access to new features that can benefit the therapy management or pay several thousand dollars out-of-pocket B2B first in line to access the newest technology. In fact, we're preparing to begin shipping new t:slim X2 pumps with G5 integration within 30 days of FDA approval and we expect the current t:slim X2 customers will simply be notified of the update via email and then be able to update their pumps to the new software even sooner. While bringing this pump to market is a top priority for our company equally so our two automated insulin delivery products that we also plan to offer customers as an update to their t:slim X2 platform. Since our last call, we've engaged in several productive discussions with the FDA on our first automated insulin delivery pump with t:slim X2 with predictive low glucose suspend. We recently filed the IDE for a pivotal study and are preparing to commence the study in the upcoming weeks. As a reminder, we anticipate a six-month review process for t:slim X2 with PLGS because it will come shortly after the FDA review of the t:slim X2 with G5 integration. The only different feature will be the PLGS algorithm and so we are preparing for launch in early 2018. Activities also continue to progress surrounding our second-generation automated insulin delivery algorithm which will include our t:slim X2 platform with the treat-to-range technology that we licensed from TypeZero, as well as Dexcom's G6 sensor. With TypeZero's technology, our product will deliver automated correction boluses in addition to adjusting basal insulin. As a reminder we are participating in the NIH-funded International Diabetes Closed-Loop Trial alongside TypeZero and Dexcom. We plan to use the data from this trial as our pivotal trial data in a PMA filing with the FDA. Based on traditional review times, we are targeting launch of the TypeZero algorithm or in our t:slim X2 platform by the end of 2018. As you can see, we're making great progress with our future products in addition to the strength we offer in our t:slim X2 platform today. I think this is recognized by Medtronic as we increasingly hear of their sales efforts focused on discussing our company's stock price or financial condition, rather than product offerings and customer support. In addition, they are pressuring customers to make a commitment to purchase the 630G before artificial deadline which happens to coincide with Medtronic's fiscal year end in order to have priority access to the 670G. We see these tactics as Bayou Theatrics intended to redirect the attention of customers in healthcare providers away from the products themselves, promote peer and suppress choice. As I said in my opening remarks, we are firm believers in market choice and the rapid growth we have experienced underscores the demand in the diabetes community for new and innovative products. Our employees are extraordinary and with their continued support we will continue to deliver our number one rated customer service in advance our key programs even in the face of these negative campaigns. Most importantly, we expect to continue offering the diabetes community a superior product that is always designed with the user in mind and best-in-class customer support. As for our cash needs, we will always seek to appropriately capitalize our business. In addition, we are implementing measures that will help to reduce our cash burn and remain confident that we will spend less in 2017 compared to last year. We expect the t:slim X2 these with G5 integration will be highly competitive and will drive new pump sales in addition to our pump renewals and increase infusion set sales that will benefit the back half of the year. Our goals for 2017 focus on successfully executing our business plan, supporting our customers and building shareholder value. We remain confident that our differentiated insulin pumps, the power of our Tandem Device Updater and our robust pipeline position us well to compete both in the near-term and long-term. I'll now turn the call over John, who will provide further detail on our results for the quarter in our financial guidance.