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Ladies and gentlemen, thank you for standing by. My name is Sharell and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Q2 2023 Investor Update Conference Call. [Operator Instructions]. I would now like to turn the call over to Matt Roache, Director of Investor Relations. Your line is now open.

Thank you, Sharell. Good morning, and thanks for joining us for our second quarter 2023 investor update. Our press release issued this morning can be found on our website. Today's call and accompanying slides include forward-looking statements. Such statements involve risks and uncertainties that may cause actual results to differ materially. A discussion of these statements and risk factors is available on the current safe harbor statement slide as well as under the heading Risk Factors in our annual report on Form 10-K in the year ended December 31, 2022, and in our subsequent SEC filings. All forward-looking statements speak as of the date of this presentation, and we undertake no obligation to update such statements. Also included are non-GAAP financial measures, which should be considered only as a supplement to and not a substitute for or superior to GAAP measures. To the extent applicable, please refer to the tables at the end of our press release for a reconciliation of these measures to the most directly comparable GAAP measures. During today's call, Tom McCourt, our Chief Executive Officer, will review our strategic priorities and our pipeline; and Sravan Emany, our Chief Financial Officer, will provide an update on the commercial performance of LIN

Thanks, Matt. Good morning, everyone, and thanks for joining us today. I'm excited to provide an update on our progress on what has been a transformative quarter at Ironwood. First, I'm pleased to announce that we are increasing our full year LIN

Thanks, Tom, and good morning, everyone. I'm happy to provide additional details on what was a very exciting and transformative quarter for Ironwood. Starting on Slide 9. As Tom mentioned a few moments ago, both LIN

[Operator Instructions]. Your first question comes from the line of Tim Chiang with Capital One. Your line is now open.

Hi, thanks. I've just got a few questions. I think maybe the first question is on the improved pricing for LIN

Yes. So, thanks, Tim. Good to hear from you. So, I think from a pricing perspective, for the first few quarters, we experienced favorable pricing relative to our initial guidance and expectations. And I think as we disclosed, that's due to favorable channel mix. First half pricing trends have been improved our outlook for the full year. And as you can imagine, when you have the volume of LIN

Got it. And then maybe just a follow-up on apraglutide. I mean obviously, you've adjusted the time line for the top line readout. Is there any change -- is it really just screening related? Is that the reason for the push out on the release of the date of data?

Yes. So, I think we always said is -- I think the key here, Tim, is that we elected to enroll all the patients that made it successfully through the STARS study and the screening process. And so, as Tom mentioned, we have a commitment to those patients and a commitment to those sites. And in order to maintain the global diversity of the trial, we believe this is beneficial for the patients and our overall global development opportunity. And so, we're excited that the trial enrollment is completed, and we've got 164 patients. And with that, I think we'll have something to report out in the first quarter of next year.

Tim, this is Tom. I think this is a discussion that we had, obviously, with the Vectiv team. And the process of screening these patients is pretty robust and challenging. And we're asking patients to go through an awful lot during the screening process. So, we felt obligated to really include them into the trial. We felt it was absolutely the right thing to do. We had good alignment with VectivBio on that. Plus, it certainly strengthens the overall diversity of the study as we think about a global program as we think about the future filings of the product. So, we are absolutely delighted with where the program is at. Certainly, everything looks right where it needs to be. And I think we have great conviction and confidence in the clinical development program at this point.

And two final points on top of that, which is one that it's an extra 20 patients in the trial in the study. And then two, notwithstanding the extra 20 patients, we still expect to have a 2025 launch, and there's no impact from our perspective on the timing of our commercial launch.

Got it. Thanks. The details are very helpful. Thanks.

Your next question comes from the line of Boris Peaker with TD Cowen. Your line is now open.

Good morning, and congratulations on strong LIN

Andrew, why don't you kind of take the first crack...?

Yes. So, on that first question on LIN

I mean, Boris, the other -- I think part of that, too, is certainly, the pediatric indication was a strong endorsement of the overall profile of the drug, which I think has a significant halo effect. I'm sure we'll better understand what we think the upside potential is for pediatrics. It's still early. But Andrew and the team are taking -- really evaluating how promotional responsive this is to really understand how hard we can push or how hard we should push on the investment side. But I think this is -- I mean, as you know, it continues to be a remarkable drug to see this kind of linear growth and even acceleration in growth, particularly with the new to brand to see a 15% increase in new to brand at this point on the base business that we have, this is pretty remarkable.

Yes. And so, we're just seeing these new patients continue to compare [ph]. And then I think the other piece is a strong profile remains the same, right, clinically, huge patient satisfaction. I think the things that have made LIN

Yes. So, on generic Gattex, I mean, tough to say what's going through another pharmaceutical manufacturers' mind on what they're doing strategy-wise. But at the end of the day, peptides are not always easy drugs to make an easy drug to bring to market. I think there's a number of kind of market dynamics for a generic to make it challenging. So, we haven't seen it yet. I think maybe not the most unexpected outcome for us at this point.

Yes. Boris, I mean as far as we're concerned, that's nothing but good news. When you look at kind of where Gattex in and when you look at the profile, of apraglutide with regard to its potency and its half-life, I mean this really could be a significant advancement in care for patients.

Andrew, Congratulations. And thanks, taking my questions.

Your final question comes from the line of David Amsellem from Piper Sandler. Your line is now open.

Thanks. So, on the Gattex generic question, I know it's hard to make. It's a peptide and all that. But I guess my question here is, to the extent that Gattex does lose exclusivity, how are you thinking about payer dynamics for apraglutide? How are you thinking about pricing for apraglutide? So just help us understand the commercial implications of a loss of exclusivity for Gattex. And then secondly, for the STARGA

Yes, Andrew, why don't you start with the first one?

So, on the generic Gattex question, I think maybe it's a little bit early on where we are in terms of for us to specifically guide on price. But I think I can say that this is certainly something that we considered and modeled out when we did the transaction. So regardless of if there's a Gattex generic or there's not, I think we feel quite comfortable about the investment we've made here and the strong opportunity there is rapidly tied in the future. And with respect to the STARGA

Yes. I think the big part here is what is -- where is the greatest opportunity for value creation. And obviously, that's something that we'll critically assess. I mean I don't think we're at this point we're tied to any specific outcome, we'll evaluate. I think a lot of it has to do with what the profile ends up looking like as to how assertive we would be in this space. But I think we're very data-driven. We're very evidence-driven. It will certainly make a good choice. And we're -- I mean, this is a huge unmet medical need. Keep in mind, the biggest problem here is the GI problems associated with this. And when that occurs, obviously, the GI community is involved and consulted. So, they certainly would play a role even though they don't directly often care for these patients, they're often consulted on these patients. Operator?