Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) Q3 2023 Earnings Call Transcript

Sravan Emany: Yes. Thanks, Boris for your questions. On the first question, I’ll take it and then Mike can again obviously add additional color. I don’t think we ever is — I think our plan is always to run this trial to completion before we read out any results and we’ve always contemplated that being a 2024 event. I think at this point in time, we’re able to say that we think we’ll be able to have a readout in the third quarter of 2024 for the trial. And I think that’s when you’ll see a more complete data set around the primary endpoint. Mike, I don’t know if there’s anything else

Mike Shetzline: I think it’s fair.

Sravan Emany: All right. And then the second question do you want to take the second one?

Mike Shetzline: Yes. So for the antroautonomy [ph] question, it’s a good question. Clearly there was enteral economy achieved in the CLEPA program that’s in the public domain. And you may have seen from our presentation at the UEG meeting, on the SAR nutrition data that we had antroautonomy achieved in the nutrition study as well. Going have to be a higher percentage in the 14% that glepaglutide has published. But nonetheless it’s a small open-label study. So we’re just looking forward to the Phase III data to better define those outcomes for the patient populations we have in the STAR study.

Boris Peaker: Great. Thanks for taking my question.

Operator: Thank you for your question. [Operator Instructions] Our next question is from the line of Tim Chiang with Capital One. Your line is live.

Tim Chiang: Thanks. You know, since we’re almost done with 2023 and obviously you’re doing still quite well with LINZESS. I sort of wanted to get your thoughts on how you sort of look at growth rates for LINZESS for next year? Obviously, you’ll probably provide some guidance at the beginning of next year. But how do you guys think LINZESS is situated at this point?

Sravan Emany: Thanks, Tim. Good to talk to you. I think as we’ve said already we’re excited about the performance of LINZESS right now and the volume growth we’ve had in 2023. The fact that we’re in year 11 of the drug still driving high single-digit demand growth is just a great outcome. And so we think that there are a lot of untreated patients continue to be in a growing market. So we’re excited about that. With respect to future guidance I think we’ll give guidance at the appropriate time which is next year in the early part like we always did.

Tom McCourt: Yes. I think, Tim this is Tom. Well it’s been really remarkable over the last three years how steady the growth year-over-year has been. And certainly this year has actually been stronger than we’ve seen in a long time. And what’s probably the most important lead indicator here is the volume increase in new-to-brand patients. We’re at a 15%, 16% increase year-over-year which is always probably the most — the best predictor of future growth. So we’re certainly not signing up for a 15% increased number for next year. But certainly it’s looking very, very strong. And certainly, we’re still assessing the upside from the pediatric indication. There’s no question we’re seeing some growth there. And we really to really understand, kind of, how much we should be investing in that growth opportunity. But I think things look bright and I think we’re very confident in what we’ll see next year.

Tim Chiang: Maybe just one follow-up. Obviously, we all get a lot of questions about the GLP-1s but the weight loss drugs. Have you seen any impact? I mean is there any impact to LINZESS from these LP-1 drugs for weight loss?