Good afternoon, my name is Stephanie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Lexicon Pharmaceuticals First Quarter 2015 Conference Call. [Operator Instructions] I would now like to turn the conference over to Mr. Chas Schultz, Senior Director, Finance and Communications. Please go ahead, sir.

Thank you, Stephanie. Good afternoon, and welcome to the Lexicon Pharmaceuticals First Quarter 2015 Conference Call. I'm Chas Schultz, and with me today are Lonnel Coats, Lexicon's President and Chief Executive Officer; Dr. Pablo Lapuerta, Lexicon's Executive Vice President and Chief Medical Officer; Jeff Wade, Lexicon's Executive Vice President of Corporate and Administrative Affairs and Chief Financial Officer; and John Northcott, Lexicon's Vice President of Marketing, Commercial Strategy and Operations. We expect that you have seen a copy of our earnings press release that was distributed this afternoon. During this call, we will review the information provided in the release, provide an update on our clinical programs and then use the remainder of our time to answer your questions. If you would like to view the slides for today's call, please access the Lexicon website at www.lexpharma.com. You will see a link on the homepage for today's webcast. Before we begin, I would like to state that we will be making forward-looking statements, including statements relating to Lexicon's clinical development of telotristat etiprate and sotagliflozin. These statements may include characterizations of the results of and projected timing of clinical trials of such compounds and the potential therapeutic and commercial potentials of such compounds. This call may also contain forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances, and intellectual property, as well as other matters that are not historical facts or information. Various risks may cause Lexicon's actual results to differ materially from those expressed or implied in such forward-looking statements. These risks include uncertainties related to the timing and results of clinical trials and preclinical studies of our drug candidates, our dependence upon strategic alliances and ability to enter into additional collaboration and license agreements, our ability to obtain patent protection from discoveries, limitations imposed by patents owned or controlled by third parties, and the requirements of substantial funding to conduct our drug development and commercialization activities. For a list and a description of the risk and uncertainties that we face, please see the reports we have filed with the Securities and Exchange Commission. I will now turn the call over to Mr. Coats.

Thank you, Chas, and thank you, everyone, for joining us on today's call. I will remind everyone that our objective in creating stakeholder value is deeply rooted in advancing our 2 late-stage assets. One is telotristat etiprate for carcinoid syndrome and sotagliflozin for type 1 diabetes. We believe very strongly that each of these assets by themselves will create great value for our stakeholders. If both of these assets should be successful, then we think we'd create even greater value. It's also strategically important to us that we maintain and prepare ourselves for the U.S. market for the carcinoid program, telotristat etiprate, which we'll speak a little to that this afternoon. With that being said, let's talk a little bit about how we're executing to our plan. One is that we've completed the enrollment in our pivotal Phase III clinical trial of telotristat etiprate. We have commenced enrollment in our phase -- pivotal Phase III clinical trial of sotagliflozin. We have commenced screening in our Phase II clinical trial of sotagliflozin in young adults with our partner, JDRF. We've expanded our collaboration with Ipsen to include rights for the commercialization of telotristat etiprate in Canada, and we've advanced a development candidate into IND-enabling studies for neuropathic pain with our partner, BMS. If I could remind you that telotristat etiprate, our Phase III program is progressing toward completion. The Phase III program is designed to satisfy requirements for approval both in the United States and in Europe. The Phase III randomized, placebo-controlled, double-blind study has 135 patients on somatostatin analog therapy, and the treatment period is 12 weeks followed by a 36-week open-label extension. The primary endpoint is change from baseline in the number of daily bowel movements. Again, we're very pleased to say enrollment has completed, and this program is…

Thank you, Lonnel. I will provide a brief financial update. As indicated in our press release today, we have revenues for the 2015 first quarter of $1.8 million, an increase from $0.3 million in the prior year period. The increase was primarily due to revenues recognized from our license and collaboration agreement with Ipsen. Our research and development expenses for the 2015 first quarter decreased 13% to $20.9 million from $24 million in the prior year period. The decrease was primarily due to reductions in personnel costs as a result of our restructuring in 2014 partially offset by increases in external clinical research and development costs. In connection with our acquisition of Symphony Icon, we made an initial estimate of the fair value of our liability for the base and contingent payments. Changes in this liability based on the development of the programs and the time until such payments are expected to be made are recorded in our consolidated statements of operations. The associated increase in fair value of Symphony Icon purchase liability was $1.8 million in the first quarter and $1.1 million for the prior year period. Our general and administrative expenses for the 2015 first quarter were $5.7 million, consistent with the prior year period. Our net loss for the 2015 first quarter was $28.1 million or $0.04 per share compared to a net loss of $30.8 million or $0.06 per share in the prior year period. For the 2015 first quarter, our net loss included noncash, stock-based compensation expense of $2 million compared to $2.3 million in the corresponding period in 2014. Finally, as of March 31, 2015, we had $315.1 million in cash and investments as compared to $339.3 million as of December 31, 2014. On next slide, I will update our forward-looking guidance for 2015.…

Well, we're very pleased to say Lexicon is indeed advancing our late-stage pipeline towards the market. We look at telotristat etiprate, the Phase III TELESTAR enrollment is complete. The commercial preparations are underway in the U.S. The collaboration with Ipsen has now been expanded and established in the U.S. The commercialization of telotristat etiprate in Europe is also ongoing. As for sotagliflozin, we're now in Phase III, and we are now in Phase II with the JDRF study. And both are progressing well. So we are very pleased to report that we are indeed advancing Lexicon and our assets toward market. With that, I want to thank everyone for joining us today, and we will stop here and take questions.

[Operator Instructions] Your first question comes from the line of Jessica Fye with JPMorgan. Jessica M. Fye - JP Morgan Chase & Co, Research Division: I guess, first, on the neuropathic pain asset you've identified with Bristol, can you talk about the time lines there? How long are you expecting for the IND-enabling studies? And when could this actually move into Phase I? And then also, just on the decision to partner Canada with Ipsen, was this something that was initiated by them or by you?

Well, let me start with Ipsen, and then I'll turn it over to Jeff. Is that okay? We've been in discussion with Ipsen for quite some time, and it had always been their desire to have rights in Canada. And we felt, given the advancement of our relationship with them and the capabilities that we've witnessed, that it was most appropriate to execute this arrangement with them and feel very confident about it. With that being said, I'll turn the BMS question over to Jeff.

So we've selected a candidate -- a development candidate, and that development candidate is being moved into IND-enabling studies. That usually takes between 12 to 18 months or so. But we haven't outlined -- this is obviously a partnership, and we haven't outlined specific time lines for that program as of yet. Jessica M. Fye - JP Morgan Chase & Co, Research Division: Okay, great. And maybe one more, if I can. Just are there any comments on the enrollment progress for the Phase II JDRF study?

Just that, that study has commenced enrollment and that we're pleased with how things are going so far, and the same with the Phase III study as well. That's been enrolling quite well.

And to your point, Jessica, we expect to hit our time lines as been outlined.

Your next question comes from the line of Alan Carr with Needham & Company.

This is Esther sitting in for Alan. So could you remind us what the powering assumptions for the Phase III trial for telotristat are?

Very good question. I'll let Dr. Pablo Lapuerta answer that question.

In our Phase III program for TELESTAR, the primary endpoint is the reduction in bowel movement frequency averaged over the course of the 12 weeks of the study. And the specific reduction in frequency that we're powered for is on the order of 1 bowel movement per day from the baseline that we expect to remain somewhere between approximately 5 and 6. However, the powering is done in order to give us the best chance to show robust efficacy. So our expectation is based on Phase II experience, where we showed reductions in bowel movement frequency of the order of 40% in our open-label study and on the order of 25% in our short-term placebo-controlled study. So we powered for a robust program [ph]. So our expectation is that Phase III results should look like Phase II.

Okay. So what would a clinically meaningful change look like?

A clinically meaningful change for an individual with this condition would be a reduction in bowel movement frequency of approximately 25% to 30%. So that would be a reduction from, say, 6 bowel movements a day to 4.5 or 4. For a mean change -- in a clinical trial, the mean change may be a little bit less because there are some responders on telotristat etiprate, there are some responders on placebo. So we suggest that when the results come out, you look for both the mean change in the population overall but also the proportion of patients with at least a 30% reduction in bowel movement frequency from baseline to week 12 on the 2 different treatment groups.

Okay. And could you remind us where these clinical sites are? I'm not sure if you...

We have 84 sites in North America, Europe and Australia.

And sorry, one more. What kind of endpoints will you disclose in 3Q?

We'll let Jeff Wade answer that.

So we're going to disclose top line results to the primary endpoint -- results on the primary endpoint, and we'll provide indications of efficacy. And those will be the primary thing we'll release.

Your next question comes from the line of Stephen Willey with Stifel. Stephen D. Willey - Stifel, Nicolaus & Company, Incorporated, Research Division: Just wondering to what extent, if any, additional safety data from TELECAST may be a rate-limiting step in filing the NDA. And I'm presuming you can probably get the solution started on a rolling basis and then supplement this as it comes in.

So our plan right now is predicated on having the TELECAST -- as we noted today, TELECAST enrollment is scheduled to end tomorrow. And we will -- we expect to have the data in a timely fashion to keep our time lines on the NDA filing. So it is -- it's a supportive study. But we expect to have the data -- we won't have the top line data at the same time we have the top line data from the pivotal study, but we will have it in a timely manner to support the NDA filing. Stephen D. Willey - Stifel, Nicolaus & Company, Incorporated, Research Division: Okay. So should we expect another kind of top line efficacy announcement out of TELECAST between the top line TELESTAR announcement and then the eventual filing?

I think TELECAST is really a supportive study designed to bolster our safety database, so that's the primary purpose of that study. The TELESTAR is the study that is going to provide us with evidence of efficacy. And that's -- those are the top line results that I think we should be focused on. Stephen D. Willey - Stifel, Nicolaus & Company, Incorporated, Research Division: Okay. And then just lastly, I know that there was a lot of discussion around cardiovascular outcomes in type 2 at the FDA panels for the DPP-4s, and there was some discussion around maybe future requirements being dictated within kind of a mechanism-specific context. And I'm just kind of wondering if, in your discussions with FDA, you've gotten any kind of feedback that would suggest that SGLT1 as a mechanism would be something that would kind of require a full MACE readout or maybe just a couple of the MACE subsets?

Yes. I'll sort of give my general thought, and then I'll have Pablo to answer any follow-up. But no, we've had no such conversations with the agency. I think we're proceeding as we are relative to advice that has been given. And I think we need to show that the drug is both effective and safe against the standards that you would with any type 1 product and do not believe the requirements that are in for type 2 drugs extend themselves over to -- I mean, type 2 diabetes extends themselves over to type 1. But Pablo, I'll let you follow up anything you want to add.

We'll be learning a lot about the SGLT2 class in terms of cardiovascular outcomes as the couple of the first studies read out over the next 6 months, and I think that would really be the basis for thinking about the class and the implications. In terms of SGLT1, we believe our SGLT1 inhibition is in the gastrointestinal tract, and because of that, we've never had any concerns about cardiovascular mechanisms related to our dual mechanism of action.

[Operator Instructions] Your next question comes from the line of Cristina Ghenoiu with Cowen.

I had a quick question about telotristat. Can you remind me how variable are these bowel movements in patients? Like, once you establish a baseline for a patient like in the placebo group typically, did you see any patients kind of vary like -- from like 2, 3, to like 5, 6 going back to 2, 3 or something like that?

Dr. Lapuerta?

What we've seen in general is that this endpoint of a mean bowel movement frequency averaged over the 12 weeks of the study is very precise. It's very precise because patients are giving you assessments every single day. Now in terms of week-to-week, we haven't seen that much variability in patients, just a little bit because patients take these injections of octreotide. And so some patients in screening will have a little bit of a reduction on octreotide. And unfortunately for them, the effect wears off early. So you're asking about our screening periods. We've seen some patients who start out with, say, 3 bowel movements or 5 bowel movements per day soon after an octreotide injection, but by the end of the screening up to 6 or 7 since it's worn off.

Okay. And the other question I had, besides the BMS collaboration, are there any other collaborations that you have ongoing in that we may expect to hear news from in the coming months?

Yes. I would simply say we remain opportunistic, and we have a pretty strong library of assets. And as opportunities present themselves, we will communicate to the market if we so should choose to do a deal.

[Operator Instructions] At this time, there are no additional questions in the queue.

Again, let me close out by saying thank you to all of you who have joined the call and just close by saying again that Lexicon continues to make substantial progress, and we'll keep you informed as we make additional progress throughout the next quarter. Thank you.

This does conclude today's conference call. You may now disconnect. Speakers, if you'll hold the line.