Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) Q4 2022 Earnings Call Transcript

Carly Kenselaar: Okay. Great. That’s really helpful. And then we just also had one question on SOLOIST. We were wondering if the data looked essentially the same when you looked at the group that started sota while they were still in the hospital versus patients who started sota within three days of discharge. Curious if you presented that analysis.

Craig Granowitz: Yes. So Carly, I’ll answer that one as well. I think we shared at the last earnings call and Dr. Pitt shared at the American Heart Association, it’s a terrific question. And what you see is that there was no difference in the primary endpoint between those two groups of patients. So whether you start the patient before they leave the hospital or on the day, they leave the hospital, which is about half or 600 of those patients or you start the patients within three days after leaving the hospital, the primary endpoint of cardiovascular death, emergency unscheduled hospital readmission or emergency room visit are the same. The group that we showed the 30- and 90-day 50% reduction in readmission is, again are the patients coming back to the hospital?

So by definition, that is patients that have not yet left the hospital and are coming back to the hospital. And I think you asked the right question because what we’ve shown is that overall, those patients are the same, whether in the primary end point, whether they are leaving the hospital or have left the hospital but you’re still looking at a 50% reduction in the hard clinical endpoint of hospital readmission by 30 days.

Carly Kenselaar: Okay, perfect. Thanks for taking our questions.

Lonnel Coats: You bet.

Operator: The next question is from Joseph Stringer with Needham & Company. Please go ahead.

Joseph Stringer: Hi, thanks for taking our questions. First one is on sota and HF. Just wondering if you could confirm that there were no additional requests for data from FDA sort of in and around the late cycle review meeting. And then the second one is on 9211. You mentioned you’re in partnership discussion, but a lot will depend on your upcoming meeting with the FDA. So I guess, does this mean that you are in a position to initiate additional clinical trials of 9211 and potentially a Phase 3 program post interaction with FDA and without a partnership? And then I think in some of the prepared remarks, you mentioned that you’re doing some work to optimize the proper dosing regimens. Can you just characterize what type of work that is? Is it modeling or otherwise? Thanks for taking our questions.

Lonnel Coats: Yes. Joe, I’m going to try my best to remember all your questions, but I appreciate all three. The first one, in terms of the additional data, when you get past a late-cycle review meeting, your past life cycle review meeting. So in terms of additional data, no, there’s not been any request for additional data from the FDA. We’re at the stage now where we should be entering into label negotiations and discussions. So we’re late in the process, that’s what I would say. As for LX9211 and moving into Phase 3. We wouldn’t want to do that until we have our FDA meeting, which we’ve requested. And as we know more about that, we’ll certainly keep everybody informed of that. I would just characterize overall partnership conversations as good overall conversations, good progress with parties.