Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) Q4 2023 Earnings Call Transcript

But at this point in time, we feel that given the change in the AMCAP rules from Medicaid that we anticipate, just given our volume and where our book of business has been over the last few years that’s going to affect us this year. It won’t affect us on a 2025 over 2024 perspective because it’s a year-over-year measure. But for this year, we do think that there will be a meaningful headwind from a price perspective just given our volumes on Medicaid.

Tom McCourt: I think the one thing that we are seeing is we’re seeing growth across the entire population. I think that’s important to note. You look across all doses, we’re seeing very strong growth, both in new to brand, new prescriptions as well as overall total Rxs [ph]. So, I mean that’s very healthy. We are seeing some very promising movement in the pediatric population but at this point, it’s a relatively small percent of our business, but it’s growing rapidly, and there is probably some additional exposure on the Medicaid side in the pediatric population. But I think as far as overall health of growth, we’re seeing it across all patient populations, all payer segments. So, I think it’s all heading in the right direction.

And to Sravan’s point, we see this cap change is kind of a onetime hit this year. But the most important thing that we have to continue to do is drive demand growth. It’s the one thing that’s within our control. And what we do know about this brand, it continues to be extremely promotionally responsive, but we’re going to continue to invest appropriately in the brand.

Chase Knickerbocker: Yes. Thanks, Tom. And maybe kind of piggybacking off of that. If we dig in a little bit more to the volume growth assumptions. What percentage, I guess, or what portion of that growth kind of comes from the pediatric population in your guys’ assumption? What portion of that kind of growth assumption? And then also just to ask another question before I hopped in back in the queue. On 104, I mean, pretty high price tag acquisition recently, obviously, in PBC. Maybe speak to how this kind of validates your kind of attempts at the space and way too early of a question, but if your thesis plays out here, 104 is an approvable medicine. And how do you see kind of fitting into the treatment paradigm?

Sravan Emany: Chase, we haven’t given guidance on the size of the pediatric indication. I think we’re still evaluating. It’s small, and we’re still — but it’s growing. We’re still evaluating through some of the pilots that we’re running. We extended them into this year. I think we mentioned that earlier this year. And so, as we know more, we’ll come back and give more granular guidance potentially over the course of the year. But at this time, it’s baked into our guidance. I want to reiterate what Tom said is we continue to see patients, more patients seeking care in this space. And the good news is that as the market leader, we’re seeing more patients, we get a disproportionate share, and more patients end up coming on LINZESS.

Based on the clinical profile, patient satisfaction, and formulary access, which is class-leading and just the duration on the market effectiveness. So, we do get a disproportion of that, but a lot of it is also just broader demand also as patients care. With respect to CNP-104, it’s — congratulations to the Simon Bay team. Obviously, that’s a great outcome for them. We think this space is — the reason we entered the space is we found an asset from a science perspective and a profile perspective, we think that actually, one is an extension of our GI continuum. And in terms of where we can — we, as an organization, can continue to treat GI diseases. So, it’s poor within our strategy. Two, I think we found the signs behind this asset and the potential to be disease-modifying, exceptionally interesting.

As Mike had mentioned earlier, all the other therapies on market essentially treat the underlying symptoms of PBC, there if you actually get to the autoimmune destruction whereas we think — and again, we will — with a hypothesis, which we will have more data for you in the third quarter this year. And hopefully, it’s validated that we think that CNP-104 actually will stop and arrest that autoimmune destruction. And so, which we think will be a differentiated asset in this market. And so that’s our perspective. But again, congratulations to the Simon [indiscernible].

Tom McCourt: Yes. I think this is all great news. I mean this is — it really puts a focus on it is a highly problematic disease that needs better care. So, I think it increases the intention and the momentum in this marketplace and hopefully, if we’re right, we can really take advantage.

Operator: Your next question comes from the line of Jason Butler from JMP Securities. Your line is open.

Jason Butler : Thanks for taking my questions. Just two for me. For apraglutide, could you just walk us through the gating items following positive results from STARS and a potential regulatory submission, and then just on one, how are you thinking about further investment in the pediatric commercial opportunity? It’s still early, like you said, but are you seeing signals that continue to justify investing in that business?

Sravan Emany: Yes, I’ll start with the second one, Jason, on LINZESS, just for a point of continuity and then Mike will answer the first question regarding regulatory pathway. Yes, look, early signs are very positive on pediatrics. And just from a new to brand, specific dose size that 92-microgram or so microgram dose, we feel really — we feel positive about it. We think it’s an opportunity worth pursuing between now and 2029 and worthy of the investment but again, it’s still too early to provide granular guidance as to what we think it will be in this year. And so, we’re just — as we know more, we’ll share that. We just don’t want to — given the growth profile and given how small it is right now. It’s something that we just want to be more cautious about from a guidance perspective. But we are pleased with the uptake and pleased with the return on investment.