Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) Q1 2023 Earnings Call Transcript

Operator: And our next question comes from Yigal Nochomovitz from Citigroup. Please go ahead with your question.

Yigal Nochomovitz: Hi, Lonnel and Jeff and team, thanks for taking the question. On 9211 I’m just curious, you mentioned you are going to have feedback from the FDA in this quarter on the path forward. Could you talk a little bit more about what you expect there? Have you proposed a specific Phase 3 plan for both indications? What additional validation or clearance are you expecting from the FDA with regard to those two diseases? And also regarding partnering, I know you have talked about partnering this in the past. Can you just give us an update there on how that’s going? Thanks.

Lonnel Coats: Okay, great questions. Yigal, let me turn it over to Jeff.

Jeff Wade: We are outlining with FDA to keep elements of the plan going forward into late stage development. And it’s mostly focused on the largest of these indications, which is diabetic peripheral neuropathic pain and other work that we need to do to advance the program going forward. So that’s really been the area of focus. And in addition to that, we are continuing dialogue with potential partners and we will be proceeding with those discussions as we get further into the development. But in the meantime, we are continuing to take steps to push this forward into development. And we are committed to doing that going forward, and we will do that with the feedback that we get from the agency later this quarter.

Yigal Nochomovitz: So, you would wait for a partner for starting a Phase 3 or not necessarily you might look at yourself?

Jeff Wade: So, we are pushing forward with development, and doing the work to push forward in development and advancing that. Frankly, we believe that, the way to create the greatest value in partnership is to continue to develop the drag and push it forward in development.

Yigal Nochomovitz: Okay. But you are focusing on DPN.

Lonnel Coats: Yes. Yigal, I think for us DPN is the biggest opportunity. And to Jeff’s point, we are not going to — we shouldn’t wait for a partner who will be waiting forever, trying to negotiate the proper value I think we can achieve with this program. The best way to do this is to get the FDA feedback, make sure that we are aligned around that feedback, and keep developing the program forward so that we can be in the best position to achieve the value we think this drug will have going forward. So, DPN will be our focus. I think what a partnership really provides for us if we should achieve that is it allows us to go broader than DPN. It allowed us to go beyond DPN to PHN, which is why we did that work and pursue a broader neuropathic pain indication. But in the absence of that Lexicon can advance this compound for DPN, which is what is our current goal.

Yigal Nochomovitz: Okay, great. And then on heart failure, so obviously a big day coming up in I guess 25 days. So, I wanted to drill down a little bit into this slice of the market, this transition of care in the recently worsening heart failure. I just want to get a better understanding. I mean, how much of a whitespace is this in terms of comp entrenched competitors are — what are you hearing from the channel checks as far as — are SGLT is being used off label here, or is this really an area where you’re just going to come in and be able to take share quickly given the unique value proposition that you, you’ve outlined both with the guidelines as well as with the strong data at AHA? And what’s been the — you’ve mentioned some early discussions, as you said, with the IDNs and the reimbursement and the Medicare and so on.