Q4 2023 Ironwood Pharmaceuticals Inc Earnings Call
Participants
Matt Roache; Director, Investor Relations; Ironwood Pharmaceuticals Inc
Thomas McCourt; Director; Ironwood Pharmaceuticals Inc
Michael Shetzline; Chief Medical Officer, Senior VP and Head of Research & Drug Development; Ironwood Pharmaceuticals Inc
Sravan Emany; Chief Financial Officer, Senior Vice President; Ironwood Pharmaceuticals Inc
Mohit Bansal; Analyst; Wells Fargo Securities, LLC
Chase Knickerbocker; Analyst; Craig-Hallum Capital Group
Jason Butler; Analyst; JMP Securities LLC
Presentation
Operator
Good day and welcome to the Ironwood Pharmaceuticals fourth quarter and full-year 2023 investor update call. (Operator Instructions) And finally, I would like to advise all participants that this call is being recorded. Thank you.
I would now like to turn our call over to Matt Roache, Director of Investor Relations, to begin the conference. Matt, over to you.
Matt Roache
Thank you, Gavin. Good morning, and thanks for joining us for our fourth quarter and full-year 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 for the year ended December 31, 2022, and in our quarterly report on Form 10-Q for the quarters ended June 30, 2023 and September 30, 2023, in our subsequent SEC filings.
All forward-looking statements speak as of the date of this presentation. 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 reconciliations of these measures to the most directly comparable GAAP measures.
During today's call, Tom McCourt, our Chief Executive Officer, will begin with a brief overview. Mike Shetzline, our Chief Medical Officer, will discuss our pipeline; and Sravan Emany, our Chief Financial Officer, provide a commercial update and review our financial results and guidance.
Today's webcast includes slides, so for those of you dialing in, please go to the Events section of our website to access the accompanying slides separately.
With that, I'll turn the call over to Tom.
Thomas McCourt
Thanks, Matt, and good morning, everyone, and thanks for joining us today. I'm absolutely delighted to share with you the progress we made in 2023 and why we believe our future is bright. We made important progress in 2023 toward realizing our vision of becoming the leading TI. health care company in the industry. I am very proud of Darren with team and the significant headway we made in 2023 across our three strategic priorities, which are maximized Linzess, advance our GI pipeline and deliver sustained profits and cash flow.
As we turn our attention to 2024, I'm confident in our strategy and look forward to what we expect to be an exciting and transformational year for our Company.
Let's begin on Slide 6 with a brief overview of some of our key achievements against our strategic priorities in 2023. First, maximizing Linzess in its 11th year on the market. Linzess had another terrific year as the leading prescription treatment for adults with IBS-C and chronic idiopathic constipation through 2023. Prescription demand increased a robust 10% year over year. New-to-brand prescriptions ramped up significantly, increasing 15% compared to 2022, which we believe is a key indicator for future growth potential in addition, Linzess reached an all-time high of 46% in TRx share in the combined branded and generic IBS-C and chronic idiopathic constipation market, strengthening its market leadership and in June of 2023, Linzess received FDA approval for the fund for functional constipation in pediatric patients ages six to 17 becoming the first and only approved prescription therapy for this patient population, an achievement We're incredibly proud of moving forward. Our focus remains on continuing to grow lenses, prescription demand and delivering strong brand profits and cash flow. Next, advance our GI pipeline in areas of high unmet need. Last year, we strengthened our GI pipeline with the acquisition effective bio, including its lead asset, a privatized as the next-generation long-acting GLP-2 analog. We believe a privatized, if successful, has the potential to become the standard of care in treating patients with short bowel syndrome dependent on parenteral support based on its clinical profile and the potential convenient once weekly dosing. If approved, we believe have prioritized can achieve 1 billion in peak net sales. I prioritize unique pharmacologic properties and strong clinical data to date, including the positive data from the stars nutrition study gives us confidence in the STARS Phase three study, which was on track to read out in March. In addition to a privatized, we're also excited about the progress of CMP. one for a potential a potential disease-modifying therapy for the treatment of primary biliary cholangitis or PBC. Late last year, we completed an early analysis that showed evidence of favorable T cell responses in patients treated with CMP. one oh four, supporting the mechanistic rationale for the asset, which we believe could positively impact disease progression in PBC. We're looking forward to the top line Phase two data in the third quarter. We believe both have privatized and CMP. one oh four has the potential to improve standard of care and the quality of life for patients suffering from these serious GI diseases with key data expected this year.
Our third priority is delivered sustained profits and cash flow. We're committed to being thoughtful and disciplined in our capital allocation as we strive to grow the business, achieve our vision and deliver value to patients and shareholders.
Looking ahead to 2024, we expect to deliver greater than $150 million in adjusted EBITDA while continuing to progress multiple clinical programs with the potential with the potential to deliver long-term growth. We believe the positive momentum across our pipeline programs, combined with the continued strong performance of Linzess, uniquely positions us for success of our mission to be the leader in GI. We're excited about the key near term debt data catalysts, which we believe will present the opportunity to propel Ironwood's growth and create value for patients and shareholders for years to come. At the end of this month, we will be celebrating Rare Disease Day. I'd like to take this opportunity to say a special thank you to all the employees, patients, caregivers and advocates in the rare disease community for their shared dedication to advancing and supporting new therapies for diseases with significant unmet medical need.
I would now like to turn the call over to Mike to review our pipeline by.
Michael Shetzline
Thanks, Tom, and good morning, everyone. Over the past few years, we've made significant strides to expand our footprint in GA today, we have a portfolio of innovative drug development programs with upcoming data that could be transformational for our Company. As shown on slide 8, in March, we expect top line data from the STARS Phase three clinical program of apalutamide in short bowel syndrome with intestinal failure, which was our primary focus and the value driver of the effective bio acquisition, we believe at Purdue type. It's successful and approved has best-in-class potential as the only once-weekly GLP-2 analog for the whole spectrum of patients with short bowel syndrome dependent on parenteral support, also known as SBSIS., a disease for which there is considerable unmet need. Novel STARS three trial is designed to show efficacy across both patient subtypes, stoma and colon in continuity. As you may recall, the primary endpoint is relative change from baseline in weekly parenteral Squaire volume. At 24 weeks, we view success as achieving the primary endpoint IC only once-weekly GLP-2 therapy for SBSIF. and look forward to seeing the pivotal data in March.
In addition to evaluating apalutamide for short bowel syndrome with intestinal failure, we're also looking at the asset as a potential treatment for patients with graft versus host disease or GVHD. It is expected from this exploratory Phase two study later this quarter, which will inform a decision on further investment in the program.
Next CMP. one oh four for PBC, we're encouraged by the favorable T cell responses in patients treated with CMP. one oh four that we saw last year and look forward to seeing how this may impact liver function in the top line results expected in the third quarter of 2024. We're excited about CMT. one and four because because it has the potential to be the first disease-modifying therapy for patients suffering with PBC. As there are no therapies on the market today that address the root cause of the autoimmune destruction of the liver bile ducts. And finally, IW 3,300 a wholly owned Ironwood asset for visceral pain conditions, including interstitial cystitis and bladder pain syndrome. The Phase two study is ongoing and progressing well. The near-term catalysts I just highlighted reinforce our confidence in the tremendous opportunity we have in front of us with multiple programs that we believe have the potential to improve the standard of care and the quality of life for patients suffering with GI diseases.
With that, I'll turn it over to Sravan.
Sravan Emany
Thanks, Mike, and good morning, everyone. I'll begin on Slide 10. As Tom mentioned earlier, Linzess had another very strong year in 2023. As you can see, demand growth has been remarkable over time, reinforcing that patients and health care professionals continue to choose Linzess and a growing market. We believe the strong demand momentum and success of Linzess will continue as a result of high treatment satisfaction with both patients and health care professionals, combined with increased clinical utility and the new pediatric indication, class-leading formulary access guideline recommendations, focused commercial execution and new patient starts celebration.
Next, I'll provide a brief update on the vector bio transaction. The integration of iron wooden Factive bio business operations is ongoing and progressing very well. In December, we successfully completed the squeeze-out merger under Swiss law. At that time, I would purchase all remaining outstanding ordinary shares of Vector bio for $17 per share in cash.
Next, I will provide additional details on our fourth quarter and full year 2023.
Slide financial performance. I'm pleased that we were able to meet or exceed all three of our guidance metrics in 2023.
I'll begin with Lonza. Linzess. Us net sales were $274 million in the fourth quarter of 2023, an increase of 5% compared to the 2020 to the fourth quarter of 2022, driven by prescription demand growth, 10%, partially offset by price and inventory channel fluctuations for full year 2023, as shown on slide 11, Linzess US net sales were 1 billion, 73 million and increase 7% year over year, driven by continued strong Linzess prescription demand growth of 10%. Commercial margins were 77% in the fourth quarter compared to 74% in the fourth quarter of 2022. For the full year 2023 commercial margins were 73%, in line with full year 2022.
Moving to Ironwood revenues in Q4, Ironwood revenues were $118 million, driven primarily by U.S. Linzess collaboration revenues of $114 million. For the full year, Ironwood revenues were $443 million with Linzess U.S. collaboration revenues of 430 million in the fourth quarter. And for the full year, Ironwood recorded 32 million, an 83 million income tax expense, respectively, the majority of which was non-cash. In addition, Ironwood recorded interest expense of 8,000,022 million dollars in the fourth quarter. And for the full year respectively, and recorded 1,000,019 million in interest and investment income, respectively in the fourth quarter. For the full year and for the full year, GAAP net loss was 2 million in the fourth quarter, driven by onetime noncash tax expense tied to a change, Massachusetts state laws and approximately 1 billion for the full year in 2023. As a reminder, for the full year, GAAP net loss includes a one-time charge of approximately 1.1 billion from the acquisition of active buyers. Adjusted EBITDA was 40 million in Q4 and a loss of 885 million for the full year full year adjusted EBITDA loss also includes the one-time charge of approximately 1.1 billion from the acquisition of active buyer in the fourth quarter. And for the full year 2023, Ironwood generated approximately 36,000,183 million, respectively, in cash flow from operations and ended the year with 92 million in cash and cash equivalents after repaying 100 million of the outstanding principal balance on our revolving credit facility and cash. As of the end of December, the outstanding drawn balance on the revolver was 300 million.
Next, I'll review our 2024 guidance on Slide 12. As previously stated, in January, we expect Linzess US net sales growth in the low single digits percent, driven by continued high single digit prescription demand growth, offset by mid to high single-digit price erosion primarily driven by the Medicaid and AMP cap removal legislation, which went into effect on January 1st of this year, we expect Ironwood revenue of between 435 and 455 million, and we expect adjusted EBITDA of greater than 150 million, which is in line with our previously stated expectation on announcements as effective bio acquisition of greater than 175 million of operating cash flows in 2024 to ramp up. We are very pleased with the progress we made in 2023. Ironwood is a much different company than we were just a few years ago. And we believe we have positioned 2024 as a potential transformational year for our Company.
Looking ahead, we remain focused on maximizing Linzess, advancing our GeoMx pipeline and delivering sustained profits and cash flows. We are excited about the continued strong wins, performance and the key pipeline catalysts ahead, which we believe can propel Ironwood's next phase of growth. We look forward to sharing the Starz Phase three top-line results with you in March. I want to close by thanking all of our employees, patients, caregivers and advocates for their shared dedication to advancing and supporting therapies for GI diseases.
Operator, you may now open up the line for questions.
Question and Answer Session
Operator
(Operator Instructions) Amy Levy, Jefferies.
Michael Shetzline
Hey, thanks so much for taking your question. Just two from us on CIC., it looks like glepaglutide twice daily is showing higher improvement on PSA reduction compared to Gattex and CIC. patients despite a relatively similar weaning protocol Do you view this as a sign that improved PK will translate to efficacy? Additionally, can you walk us through the order of the hierarchical testing that you'll be looking at for the secondary endpoints and where CIC. falls relative to this? And then finally, and can you give us any color on how much additional sales force that you may need to add to launch appetite in SBS and how we should model SG&A? Thanks so much.
Okay.
Sravan Emany
Thanks, Amy. I guess I'll start by handing it over to Mike can answer the first two questions now. And sir, the third on the sales force.
Michael Shetzline
Yes, thanks, and good, good questions. And so the first question you asked is related to PK and exposure around the glepaglutide program and sort of some of the findings they had, which did sort of portend to have better from parenteral support reduction perspective of outcome. And I see I see population. The root of your question is obviously what gives you the best pharmacodynamic response from a PK perspective. And we've actually modeled and looked into this quite extensively because the question is whether it's C max or whether it's a UC., right, where they need to cover the receptor for multiple times or consistently throughout time. And that's sort of the where you're getting at with the glepaglutide twice weekly that by doing it twice weekly or giving the drug twice weekly, they maintained sort of a higher trough throughout the week and is that the reason why they might see better parenteral support and reductions. We certainly think that there is an exposure related benefit to having drug chronically or at least persistently available to the receptors. And that's one of the reasons why we think the once weekly has the potential opportunity to be best in class. So we certainly consider that we're going to learn a lot from the study in terms of how to model that, that pharmacodynamic response. But it certainly is part of the the PK PD profile that we think is very positive and aspirational for a glut of glutamate.
And the second question you asked is about the key secondaries. So we have taken into account statistically the secondary endpoints, obviously to have future discussions with the agency on potential label language. Those key secondaries are that first one is really the reduction of at least one day off parenteral support for the total population at week 24. So it's not a subtype of question and point of the total population. The second one really looks at the Princess put volume reductions in stoma, the subpopulation at week 24. And then the third one looks at the pore volume reductions for CIC. specifically at week 48 because as we've mentioned many times, we think the CFC population takes a little longer to respond. They start with lower place, parenteral support, value needs and those kind of things. And the fourth one is what is the enteral autonomy endpoint minutes at week 48.
Sravan Emany
And then with respect to the sales force question and at launch, we will have large sales force ever arrayed against this disease states with over 90, our existing 90 reps, 90 plus reps here at ION. And from an incremental investment standpoint, I think we'll see you and as we get closer to launch or how much that needs to evolve. We don't think it's very much. We do think there will be additional investments, though and tied to selling a therapy that is a rare disease. And so that includes hub services, patient services. And there is this becomes much more of a service model where we have to follow the patient through on their their patient journey and help support them. So we'll build out some of those additional ancillary components of our sales force and our and our team. But that and we don't think is significant in terms of incremental spend and would not affect the guidance we've already given in terms of where we'll be in 2025.
Thomas McCourt
I mean, I think the this is Tom. I think the big thing to understand with the sales force deployment because we're already in the offices today that a lot of these physicians who really kind of specialize in managing these patients on reside. So that's the reason why we feel very confident that we have an adequate sales force. There may be some additional roles that will be specific for certain large GI practices that we are we're taking a look at that I think very creatively and effectively accelerate the uptake of the drug. But we're not looking at certainly a significant incremental spend and sales force.
Mohit Bansal
Great.
Michael Shetzline
That's super helpful. Thanks so much.
Operator
David Amsellem, Piper Sandler.
And today, this is Sam. On for David, as we get closer to epacadostat data, what are your latest thoughts on pricing of?
Absolutely tied to the extent that generic Gattex interior lager? And what's your latest thinking on your strategy for Apoquel type ex-US, particularly in Europe?
Mohit Bansal
Yes.
Sravan Emany
Yes. So I think, Tim, first on pricing, I think we're still I'm working on on some of that in terms of where those are where we'll price it. I don't think we've communicated yet our strategy. I think we still have some time before we feel like we're ready to do that I think a lot of it will tied to what our clinical profile actually looks like and how differentiated it actually is. And so we'll wait till we have the data in March before we start working on that.
With respect to the second part of your question, which is that for U.S. look, we're I think we're we understand them are current field and sales force is heavily US and we're open.
Thomas McCourt
I think you have some flexibility about and we'll think about MOXUS. in a very strategic manner for us I mean, you can imagine I mean, having a best-in-class product like this or potentially best in class product is we are certainly getting a fair bit of inbound interest from, but it's up. Obviously, it's something we're good at certainly take advantage of as we move forward.
And thanks, guys.
Operator
Mohit Bansal, Wells Fargo.
Mohit Bansal
Great.
Thank you for taking my question.
I have two.
So one is like how much how much information about the secondary endpoints that you just mentioned, we could expect to see the top-line release in March?
That's the first question.
And the second one is you do have a differentiated leaning mechanism from the parenteral support. Could you talk a little bit more about that? And could it impact placebo as long as we are as we look forward to the data?
Thank you.
Michael Shetzline
Yes, sure. So as I mentioned, I mean I can give you the key secondaries are described as I put them forward in the prior question. I mean, the main one is the days off one at least one day off parenteral support. You may recall that's kind of a standard endpoint. It's been around since the Gattex phase because Gattex user responder definition and the responder was a 20% reduction. And that translated roughly like one day out of the week and stuff like that. But that's sort of been one that's been compared across our agents and agents in the class hub. And then the other two are we're really just trying to get granular on the subpopulations between settlement and CIC. and the stoma is at 24 weeks as we mentioned, because oftentimes the stoma populations have a higher principal value need and they tend to respond more quickly. That's why the 24 week is also at that point for that reason. And the third one is I see I see specific subpopulation, but that's a French's portfolio reduction at week 48 because they often take longer respond. And then finally, enteral autonomy, which is the complete we've seen off of parenteral support, which we think is of value value to patients. And then we'll certainly share the data in March with the top line results.
And the second question, you talked about the winning algorithm, the waning of the aspect of waning as obviously a meaningful part of the study, right? But the aspect of the difference between stoma and CSC has been around since the Gattex days and really became clear sort of in the post marketing approach to Gattex with patients because even those I see I see sub-population did not participate in the primary endpoint in the Gattex program or even the glemba program on really highlighting the differences between CIC. and a stoma, the real data as it looking closer at that data, it really became clear that the reason for that is I see I see patients start with a lower pressure for volume at baseline and therefore make smaller incremental reductions. And that called into question this 10% threshold for urine output to define who gets to wean. And so that got to a lot of external discussions which are happening for the last decade. Honestly, I could see I see patients participate in the primary endpoint if they could win without hitting the 10% endpoint. And that's what the winning algorithm is all about saying if patients in their weaning have greater than 10% reduction or increase in urine output, they can win all patients, but if they have less than 10% and there I see I see patient, then they go through a bunch of other parameters like their diet like they're still input their nutritional status or stool output on their nutritional status, their body weight and all those parameters. And if they're all in line and the subjects doing nutritionally very well that even if they don't hit the 10%, they could still participate in winning the winning algorithm we used in the stars nutrition and study, and you saw that data presented at UEGW and the patients who very well granted a small nine patient open-label study, but they all did respond and did were able to wean. And so the point to the question you asked about the placebo response is a good question. We have that's an open-label study. So we certainly got the treatment effect from that study. We had a 40% reduction in Princess providing at week 24, that increased to 52% by week 52 and week 52. So we certainly think there's an opportunity for therapeutic gain to your point about placebo. We roughly look at the placebo response at an agnostic of of that aspect across the patient population. So even including what we've seen in other studies with a placebo responder placebo response around the 20%. We think there's certainly room there for therapeutic gain with the winning algorithm, NCIC. patients canceled.
Thank you very much.
Mohit Bansal
For.
Operator
Chase Knickerbocker, Craig-Hallum Capital Group.
Chase Knickerbocker
Good morning, guys, and thanks for taking the questions. I actually wanted to start with Alon's ask questions later, not a hub, so I won't go on to start. I just want to dig in a little bit deeper on 2020 for net revenue guide and maybe talk about the different moving pieces that could drive outperformance or underperformance on that guide from a standpoint of the net pricing decline assumptions. So you guys like pretty confident in those assumptions, you know, is the assumed pediatric growth driving some increased Medicaid exposure that actually makes that erosion a little bit worse. And you know, what does additional pediatric exposure or differing patient mix kind of due to that erosion kind of assumption?
Sravan Emany
Good morning, Chris.
Michael Shetzline
And so thanks for your question.
Sravan Emany
I would say our guidance is pretty straightforward and consistent with how we've done it in past years, which is at this point in time, we're still anticipating high single digit volume growth, your over a very strong 2023 the fact that we're going to still grow another year from a volume perspective, and that's going to be high single digits. Again, it's pretty impressive in my mind. We also gave guidance at the JPMorgan Healthcare Conference. And we think today that the one that we think the price erosion and any other fluctuations will actually be mid to high-single digit headwind of low single digit growth. And for the full year. Now, if some of those headwinds do not materialize, we could have a year that resembles last year. But at this point in time, we feel that the given the and the change in the Amcast rules for Medicaid that we anticipate just given our volume and where our book of business has been over the last few years and that that's a 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 a meaningful headwind from a price perspective.
Thomas McCourt
And just given our volume and volumes in Medicaid, 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, if you look across all doses, we're seeing very strong growth both in new to brand new prescriptions as well as overall total RXs. So I mean, that's very healthy and we are seeing some very promising promising move. But in the pediatric population 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 Joe, is it's all heading in the right direction to Trevor's point, we see this and campground 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. That's the one thing that's within our control and what we do know about this brand, it continues to be extremely promotionally responsive. So we're going to continue to invest appropriately in the brands.
Michael Shetzline
Yes.
Chase Knickerbocker
Thanks, Tom. And maybe kind of piggybacking off of that, if we dig in a little bit more to that and 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 was the portion of that kind of growth assumption? And then also just the asset.
Then another question before I hop back into queue on one oh four. I mean, pretty high price tag acquisition recently, obviously in PBC and 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, one oh four is an approvable medicine and how do you see it kind of fitting into the treatment paradigm?
Thomas McCourt
So Greg, yes.
Sravan Emany
So I since we haven't given guidance on on the size of the pediatric indication, I think we're still evaluating. It's small. We're still, but it's growing. We're still evaluating. And 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 we'll we'll 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 is 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. And I'm coming on lenses based on the clinical profile of patient satisfaction and and formulary access, which is class-leading. And just I just had the duration on the market effectiveness. So we do get just portion of that, but a lot of it is also just broader demand also as patients seek care.
And with respect to CMP, one of for Al, congratulations to the CymaBay team, obviously, and that's a great outcome for them. We think this space is the reason we entered the space as we found an asset from a science perspective and a profile perspective. We think that actually one is an extension of our Chennai continuity continuum in terms of where we can. We as an organization, can you treat GI diseases, so fits core within our strategy. Two, I think we found the science 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. Very few actually get to the autoimmune on 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 CMP one or four actually will start and arrest that autoimmune destruction and so which we think will be a differentiated asset. And so that's our perspective. But again, congratulations to some of you.
Thomas McCourt
I think this is all great news. I mean, this is it really puts a focus on. It is a high, highly problematic disease that needs better care. So I think it increases the attention and the momentum in this marketplace that hopefully, if we're right, we can really take advantage of.
Mohit Bansal
Great. Thanks.
Operator
Jason Butler, JMP Securities.
Jason Butler
Hi. Thanks for taking the questions. I had just two for me for aggregates and could you just walk us through the gating items following positive results from stores and a potential regulatory submission? And then just on that, 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 that continues to justify and investing in that in that business?
Yes, I'll start with the second one, Jason, on lenses. Just the point of continuity and then Mike will answer the first question regarding regulatory pathway on, yes, look into early early signs are very positive on pediatrics and just from a new-to-brand specific dose size, that's a 90 microgram or so your microgram dose, we feel really good.
Yes, 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'll just some 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. And it's something that we just want to be more cautious about from a guidance perspective, but we are pleased with the uptake and am pleased with the return on investment, but we're not seeing a dramatic increase in our investment, I think in in a maybe a refinement of our marketing mix.
Thomas McCourt
I mean, there's no question, you know, we're running a number of pilots, digital pilots, right now certainly sales files right now. And we're taking a critical look to the whole Medicaid exposure piece, which has been part of the equation with regard to where we're going to focus our activity and investment. So I think we're very we're very pleased with what we're seeing is from inside, but we certainly are going to be very, very disciplined with regard to how we invest our money is.
And at this point in the lifecycle, yes.
Michael Shetzline
So yet further appetite for the Phase three. I mean, honestly, we're clearly 110% focused on the March top-line results and very much committed to that and delivering that. So we all can understand where we are. And then of course, we still have a launch opportunity for 2025, which we're focused on and they've been in between that that will all fall in as we see the data in March.
Operator
As a reminder, if you wish to ask a question, please press star followed by one on your telephone. And your next question comes from the line of Tutogen of Capital One.
Your line is open Thanks, Mike. I wanted to ask you a couple of questions just on like obviously business, there's not going to be any head to head data it with copper glued titled and type and Gattex. But just looking at the Gattex label, obviously, that drug was approved a long long time ago on the primary efficacy endpoint was a clinical response measurement. And I wanted to get your comments on it because obviously, let's assume you have good data in March, but how would you sort of I mean, will you provide data on the secondary outcome measure of at least a 20% reduction of parental support volume from baseline at week 20 in 24, just sort of a relative comparator to Gattex?
Mohit Bansal
Yes.
Michael Shetzline
Thanks, Tim. So you're exactly right. And I kind of alluded discipline to make other comments, but the CapEx program had a responder definition responder definition required a 20% reduction in principal volume to be responder. And that actually translates quite well to the endpoint of the reduction in at least one day of the week. In fact, you may recall, I don't know if you're aware, but at the Gattex Advisory Committee, it all came down to that front from the agency is one day a week meaningful. And does this sort of 20% relate to that, meaning a responder definition of. And it was a key discussion point and clear that the advisors agreed and it ultimately got NPS is approval for Gattex, ensure best syndrome requiring parenteral support of So edge. So for us, it translates into that one day off to your point, we have a 20% reduction endpoint, but it's not one of the key secondaries that's statistically accounted for because it's also in the regulatory discussions taken a second seat to the parenteral support readout volume reduction at 24 weeks as well as the one day off, and I'm not sure how the discussions have gone with the agency, but they do very much correlate them whether you take the relative change from baseline or percent change it does those volumes do looking translate pretty well. And if you look at Glip is at primary was a little nuance to is the percent change. They didn't use the responder definition gets exited. But if you look at the data, it actually translates pretty well across the two studies, even 10 years apart, which I thought quite quite interesting given the nature of short bowel syndrome, it's intestinal failure.
Okay.
That's helpful, Mike. And I guess just the common ground between the data that we have with Gattex and Glatopa is that they have obviously shown basically about it, 2.42 liter reduction per week in parenteral support it needs, right. I mean and that's sort of like the absolute delta over over placebo. So I just wanted to make sure that that's sort of I mean, if you can get that similar type of efficacy, that would be considered a win, Mike?
Mohit Bansal
Yes.
Michael Shetzline
Well, I think right now, I mean, you're getting to the granular volumes. But honestly, right now for us, the winner is going to be the statistics around the primary endpoint. I mean, because that's how it's going to play forward with the agency perspective, and that's what we're committed to delivering. But we certainly will have all that data, Tim, as things roll forward just like it happened with the CapEx CapEx and the glemba programs. A lot of those more nuanced volume data is to come out later because the primary top line data easily six that is statistically relevant endpoints from a first run perspective. And then we'll have multiple scientific sessions, which will continue to rollout data to inform us of the study outcomes.
I mean is it possible that some of this more specific data might be able to be released at like an upcoming medical conference like DDW?
Michael Shetzline
Or do you think you'll you won't make the cut off well, the abstract deadline for this CDW's for us last December. So it's that's kind of a there's obviously the fast track point. But the point is for the top line, we really stick to the statistically relevant endpoints. So they're going to they're going to be there be a lot of data coming later.
Got it. Okay, thanks.
Mohit Bansal
Thanks.
Much, Mike.
Mohit Bansal
Yes.
Operator
As there are no further questions, I would like to thank our speakers for today's presentation, and thank you all for joining us.
This now concludes today's conference. You may now disconnect.
