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

So while we’re encouraged by the early look and by the favorable findings, we do need to remember that as a reminder the primary endpoint for the Phase 2 has safety tolerability as well. As well as ALFAS really looking forward to that data set to better understand what these changes in the peripheral T-cells mean on clinical endpoints.

Tom McCourt: Thanks Jason.

Operator: Thank you for the questions. Our next question is from the line of David Amsellem with Piper Sandler. Your line is live.

David Amsellem: Hey thanks. So, just had a couple of commercially oriented questions on apraglutide. Can you just remind us of the size of the CIC patient subgroup relative to the stoma subgroup? That’s number one. Number two is what is the approximate if you have this patient footprint or number of patients that are on Gattex and what’s your estimate of the patients the number of patients over time that have cycled through it? That’s number two. And then lastly just latest thoughts on how are you thinking about pricing of apraglutide to the extent that a generic of Gattex materializes? Thank you.

Sravan Emany: All right. So, I think I’ll start on the first one and then Mike you can check me on this. Our estimates right now are that the market is essentially 50/50 between stoma patients and CIC patients. The overall market size is rough globally is 17,000 patients. And so — and it’s roughly 50/50 between the two subsets. Number two with respect to the patient footprint on Gattex and the number of patients treated I think our — again this is all public information and this is to be checked I think our understanding is that it’s about 2,000 patients in the US that have been treated by Gattex. And so that’s the number that we have. And then third David on pricing. I think Tom already answered this question. I think we’re going to — the Gattex already has a number that’s out there.

With respect to the idea of a generic I think our view is we’re going to come with a very interesting and compelling data package here hopefully in that we’ll find out in a few months. But hopefully we’ll have a compelling data package to bring to the market and something that will be quite competitive. And then I think on top of that the idea of a generic we don’t really see the generics being that viable here. Just there’s not that much patient population as you can see from Gattex only having treated 2,000 patients in the United States. It’s not an asset for a disease state we think is heavily managed. And there isn’t a lot of volume to get from or massive reduction in price in this one.

Tom McCourt: And I think we also feel that there’s probably it’s not a real high probability that we’ll see a generic. Certainly, there’s been and end of file but nobody has really acted on it. And obviously you’re going to have to maintain our rems program et cetera. So, this is and there’s a lot of mechanics to be able to launch a generic and support the generic. So, I do think that — and I think when you look at the fact that about 50% of patients discontinued therapy on Gattex within the first year, I think it speaks to the limitations of the drug. And I think, having a drug move from like daily injections to once-a-week injection and a drug that’s certainly more potent and longer-acting, really could help a broader patient population particularly the CIC patients.

Tom McCourt: Thanks, David.

David Amsellem: Thank you.

Operator: Thank you for your question. Our next question is from the line of Boris Peaker with TD Cohen. Your line is live.

Boris Peaker: Great. A couple of questions for me. First on 104, just curious why aren’t you disclosing the T-cell data? Or maybe another way to ask it is when will we see the actual T-cell data? And then on the apraglutide, if we look at Zelanepaglutide [ph] they showed a 14% of patients that come independent of parenteral nutrition. I’m just curious how important is that in terms of kind of assessing the apraglutide data.