Lonnel Coats
Analyst · Citigroup
Thank you, Kim. Good morning, everyone, and thanks for joining us on today's call. I will share with you some recent key events and conclude with a business update. I'll then turn the call over to Dr. Pablo Lapuerta, our Chief Medical Officer, for updates on our sotagliflozin programs, and to Jeff Wade, our Chief Financial Officer, for an update on our financial results. We had a productive third quarter as we and our collaborator, Sanofi, worked diligently to prepare for a potential FDA advisory committee meeting. As a reminder, sotagliflozin has an expected PDUFA date of March 22, 2019. In parallel, we continue to highlight clinical data for sotagliflozin with 4 poster presentations and 1 oral presentation at the European Association for the Study of Diabetes or better known as EASD, at their annual meeting. Coming out of EASD, we were pleased by the feedback from key opinion leaders and endocrinologists that SGLT inhibitors have a place in type 1 diabetes treatment landscape that the benefits are significant to patients and that the risk of diabetic ketoacidosis, while serious, can be managed. On the XERMELO front, we achieved U.S. XERMELO net sales of $6.3 million in third quarter of 2018, up 19% over the prior year quarter and 5% from the second quarter of 2018. We saw a continued increase in our patient base, and we saw 1/4 of XERMELO dispenses coming from the patient assistance program or free drug. We anticipate that the dynamics from the patient assistance program will persist through the remainder of this year and will follow us into next year. Total paid prescriptions, or TRx, for the third quarter was 1,227 up from 1,171 in the second quarter. Patient demand grew 6% quarter-over-quarter and 47% year-over-year as measured by total units, which includes patient assistance or free drug. There were 132 new patient starts. The overall discontinuation rate remains in line with our expectations. We continue to see increased numbers of patient restarts after drug discontinuation, and we anticipate this trend will continue. The compliance rate remains around 80%, which we believe to be quite remarkable. While the launch metrics have improved, we will likely fall shy of achieving our objective of doubling XERMELO net sales in 2018 from 2017's $15.1 million. We believe that achieving XERMELO net sales at a range of $24 million to $27 million is a reasonable expectation for this year. Turning to ex U.S. Our collaborator, Ipsen, continues to obtain approvals for XERMELO in other territories. In the third quarter, XERMELO received approval in Australia and was launched in Switzerland and Sweden. In addition, we recently announced that XERMELO received approval from Health Canada. We're making steady progress on the XERMELO launch, and we believe we have an opportunity to substantially expand the market for XERMELO over time. We believe inhibition of tryptophan hydroxylase and reduction of serotonin production have additional therapeutic applications. We're doing work to expand the opportunity for XERMELO by initiating a Phase II study in biliary tract cancer, while we'll be exploring telotristat ethyl plus first-line combination therapy with a progression-free survival end point. We've also received considerable inbound interest from investigators to examine to telotristat ethyl in other cancers, including neuroendocrine tumors, and we will support selected investor sponsored studies in these areas. We continue to make progress on remaining of our early-stage pipeline. We have completed the multiple-ascending dose portion of the Phase I study for LX2761, which is our locally acting SGLT1 inhibitor and anticipate data in the fourth quarter. For LX9211, which is of our candidate for neuropathic pain, we have completed the single-ascending dose portion of the Phase I study in healthy volunteers, and we expect data in the fourth quarter. Now I'd like to turn the call over to Dr. Lapuerta, who will provide an update on our sotagliflozin program.