Ironwood Pharmaceuticals Inc Q4 FY2023 Earnings Call

Good day, and welcome to the Ironwood Pharmaceuticals Fourth Quarter and Full Year 2023 Investor Update Call. I would like to remind all participants that this call is being recorded. Thank you. Now, I would like to invite Matt Roache, Director of Investor Relations, to start the conference. Matt, it’s yours.

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 our quarterly report on Form 10-Q for the quarters ended June 30, 2023, and September 30, 2023, and 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, will 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 slide separately. With that, I'll turn the call over to Tom.

Thanks, Matt. 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 GI healthcare company in the industry. I am very proud of the Ironwood team and the significant headway we made in 2023 across our three strategic priorities, which are: maximize LINZESS, advance our GI pipeline, and deliver sustained profits and cash flows. 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. In 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 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 LINZESS subscription 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 of VectivBio, including its lead asset, Apraglutide as the next-generation, long-acting GLP-2 analog. We believe Apraglutide, 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 Apraglutide can achieve $1 billion in peak net sales. Apraglutide's 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 3 study, which is set to read out in March. In addition to Apraglutide, we're also excited about the progress of CNP-104, 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 CNP-104 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 2 data in the third quarter. We believe both Apraglutide and CNP-104 have 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 to deliver 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 to deliver long-term growth. We believe the positive momentum across the pipeline, combined with the continued strong performance of LINZESS, uniquely positions us for success in our mission to be the leader in GI. We're excited about the key near-term 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.

Thanks, Tom, and good morning, everyone. Over the past few years, we've made significant strides to expand our footprint in GI. Today, we have a portfolio of innovative GI 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 3 clinical program of Apraglutide in short bowel syndrome with intestinal failure, which was our primary focus and the value driver of the VectivBio acquisition. We believe Apraglutide, if 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 SBS-IF, a disease for which there is considerable unmet need. The novel STARS 3 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 score volume at 24 weeks. We view success as achieving the primary endpoint as the only once-weekly GLP-2 therapy for SBS-IF and look forward to seeing the pivotal data in March. In addition to evaluating Apraglutide 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. Data is expected from this exploratory Phase 2 study later this quarter, which will inform a decision on further investment in the program. Next, CNP-104 for PBC. We're encouraged by the favorable T-cell responses in patients treated with CNP-104 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 CNP-104 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. Finally, IW-3300, a wholly owned Ironwood asset for visceral pain conditions, including interstitial cystitis and bladder pain syndrome. The Phase 2 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 from GI diseases. With that, I'll turn it over to Sravan.

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 healthcare professionals continue to choose LINZESS in 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 healthcare professionals, combined with increased clinical utility from the new pediatric indication, class-leading formulary access, guideline recommendations, focused commercial execution, and new patient start acceleration. Next, I'll provide a brief update on the VectivBio transaction. The integration of Ironwood and VectivBio business operations is ongoing and progressing very well. In December, we successfully completed the squeeze-out merger under Swiss law. At that time, Ironwood purchased all remaining outstanding ordinary shares of VectivBio for $17 per share in cash. Next, I will provide additional details on our fourth quarter and full year 2023 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 LINZESS. LINZESS U.S. net sales were $274 million in the fourth quarter of 2023, an increase of 5% compared to the fourth quarter of 2022, driven by prescription demand growth of 10%, partially offset by price and inventory channel fluctuations. For full year 2023, as shown on Slide 11, LINZESS U.S. net sales were $1.73 billion, an increase of 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 and $83 million income tax expense, respectively, the majority of which was noncash. In addition, Ironwood recorded interest expense of $8 million and $22 million in the fourth quarter and for the full year, respectively, and recorded $1 million and $19 million in interest and investment income, respectively, in the fourth quarter and for the full year. GAAP net loss was $2 million in the fourth quarter, driven by a one-time noncash tax expense tied to a change in 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 VectivBio. Adjusted EBITDA was $40 million in Q4 and a loss of $885 million for the full year. The full year adjusted EBITDA loss also includes the one-time charge of approximately $1.1 billion from the acquisition of VectivBio. In the fourth quarter and for the full year 2023, Ironwood generated approximately $36 million and $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 in 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 U.S. net sales growth in the low single digits, driven by continued high single-digit prescription demand growth, offset by mid- to high single-digit price erosion primarily driven by the Medicaid AMP cap removal legislation, which went into effect on January 1 of this year. We expect Ironwood revenue of between $435 million and $455 million, and we expect adjusted EBITDA of greater than $150 million which is in line with our previously stated expectations on the announcement of the VectivBio acquisition of greater than $175 million of operating cash flows in 2024. To wrap 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 GI pipeline, and delivering sustained profits and cash flows. We are excited about the continued strong LINZESS performance and the key pipeline catalysts ahead of us, which we believe can propel Ironwood's next phase of growth. We look forward to sharing the STARS Phase 3 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.

The first question is from Amy Li from Jefferies. Your line is open.

Thanks so much for taking my questions. Just two from us. On CIC, it looks like Apraglutide twice daily is showing higher improvement on PS reduction compared to GATX and CIC patients despite a relatively similar approval. 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, can you give us any color on how much additional sales force that you may need to add to launch Apraglutide in SBS and how we should model SG&A? Thanks so much.

Okay. Well, thanks, Amy. I guess I'll start by handing it over to Mike to answer the first two questions, and I'll answer the third on the sales force.

Yes. Thanks, Amy. Good questions. So, the first question you asked is related to PK and exposure around the Apraglutide program and sort of some of the findings they had, which pointed to a better outcome in the CIC population from a parenteral support reduction perspective. 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 Cmax or whether it's AUC, right, whether you need to cover the receptor multiple times or consistently throughout time. That sort of where you're getting at with the Apraglutide twice weekly that by doing it twice weekly or giving the drug twice weekly, they maintain a higher trough throughout the week. And is that the reason why they might see better reductions in parental support? We certainly think that there is an exposure-related benefit to having the drug chronically or at least persistently available to the receptors. And that's one of the reasons why we think that 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 pharmacodynamic response, but it certainly is part of the PK/PD profile that we think is very positive and aspirational for Apraglutide. The second question you asked is about the key secondaries. So, we have taken into account statistically the secondary endpoints, obviously, for future discussions with the agency on potential label language. Those key secondaries are the first one is really the reduction of at least 1 day off parenteral support for the total population at week 24. So, it's not a subtype endpoint; it's the total population. The second looks at the parental support volume reductions in Stoma, the subpopulation at week 24. And then the third looks at parental support volume reductions for CIC, specifically at week 48. Because as we've mentioned many times, we think the CIC population takes a little longer to respond. They start with lower parental support volume needs and those kinds of things. The fourth one is the enteral autonomy endpoint, and that's at week 48.

Regarding the sales force question, at launch, we will have the largest sales force ever dedicated to this disease state with over 90 existing representatives at Ironwood. As we approach the launch, we will assess how much incremental investment may be necessary. We believe it won't be substantial, but we do expect there will be additional investments related to selling a therapy for a rare disease. This will involve hub services and patient services, creating a more service-oriented model where we support patients throughout their journey. We will develop some of these additional ancillary aspects of our sales force and team, but we do not anticipate significant incremental spending that would affect our previously provided guidance for 2025.

This is Tom. I think the big thing to understand with the sales force deployment is we're already in the offices today, a lot of these physicians who really specialize in managing these patients 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're taking a look at that I think we very creatively and effectively accelerate the uptake of the drug. But we're not looking at certainly a significant incremental spend in sales force.

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

This is Tim on for David. As we get closer to Apraglutide data, what are your latest thoughts on pricing of Apraglutide to the extent a generic Gattex materializes? And what's your latest thinking on your strategy for Apraglutide ex U.S., particularly in Europe?

Yes. So, thanks, Tim. First, on pricing, I think we're still working on some of that in terms of where we'll price it. I don't think we've communicated yet our strategy. And I think we still have some time before we feel like we're ready to do that. A lot of that will tie to what our clinical profile actually looks like and how differentiated it actually is. So, we'll wait until we have the data in March before we start working on that. With respect to the second component of your question, which is Apraglutide ex U.S., look, I think we understand that our current field and sales force is heavily U.S., and we're open to exploring some flexibility about how we'll think about ex U.S. in a very strategic manner for our company.

I mean you can imagine, having a best-in-class product like this or potentially a best-in-class product, we are certainly getting a fair bit of inbound interest. It's obviously something we're going to certainly take advantage of as we move forward.

Your next question comes from the line of Mohit Bansal from Wells Fargo. Your line is open.

Great. Thanks for taking my question. I have two. So, one is how much information about the secondary endpoint that you just mentioned, we could expect to see with 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 parental support. Could you talk a little bit more about that? And could it impact placebo as well as we look forward to the data? Thank you.

Yes, I can provide details on the key secondary endpoints. The primary one is the days of at least one day of parental support, which has been a standard measure since the Gattex phase. This approach uses a responder definition based on a 20% reduction, which typically translates to about one day per week. We are also focusing on subpopulations between stoma and CIC. The stoma data at 24 weeks is important because this group often requires more parental support and tends to respond more quickly. For the CIC subpopulation, we are looking at parental support volume reduction at 48 weeks since they generally take longer to respond. Additionally, we believe that complete lifelong parental support is valuable for patients. We will share the top-line results in March. Regarding the weaning algorithm, this aspect has been part of the study from the beginning. The distinctions between stoma and CIC populations became evident during the post-marketing phase of Gattex, particularly as the CIC patients did not contribute to the primary endpoint in the Gattex or CLEPA programs, which highlighted these differences. Our analysis revealed that CIC patients start with a lower baseline parental support volume, leading to smaller reductions, which raised questions about the 10% threshold for urine output necessary for weaning. This sparked extensive discussions over the past decade about whether CIC patients could qualify for weaning without meeting the 10% threshold. Our weaning algorithm states that if patients show greater than 10% or increased EUTRx, they can proceed with weaning. For CIC patients with less than 10%, we assess various factors such as diet, stool input, nutritional status, and body weight. If these factors are favorable, they may still qualify for weaning despite not hitting the 10% mark. We tested this weaning algorithm in the STARS nutrition study, which, while small with only 9 patients, showed successful responses and the ability to wean. To address your question about the placebo response, it’s valid; this was an open-label study with a clear treatment effect. We observed a 40% reduction in parental volume by week 24, which increased to 52% by week 52. We believe there’s potential for therapeutic gain. When considering the placebo response, we estimate it to be around 20%, and we see room for improvement with the weaning algorithm in CIC patients.

Your next question comes from the line of Chase Knickerbocker from Craig-Hallum Capital Group. Your line is open.

Good morning, guys. Thanks for taking my questions. I actually wanted to start with the LINZESS question, believe it or not. So, a longer one to start. I just want to dig in a little bit deeper on 2024 net revenue guidance. 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 look pretty confident in those assumptions. Is the assumed pediatric growth driving some increased Medicaid exposure that actually makes that erosion a little bit worse? And what does additional pediatric exposure or different patient mix kind of do to that erosion assumption?

I would say our guidance is pretty straightforward and consistent with how we've done it in the past years, which is, at this point in time, we're still anticipating high single-digit volume growth over a very strong 2023. The fact that we're going to still grow another year from a volume perspective, 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 that we think. And today, we think the price erosion and any other fluctuations will essentially be a mid to high single-digit headwind to have low single-digit growth in 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 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.

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. 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. As to Sravan's point, we see this cap change as a one-time 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 is it continues to be extremely promotionally responsive, but we're going to continue to invest appropriately in the brand.

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 growth assumption? And then also just to ask another question before I hop 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 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 it kind of fitting into the treatment paradigm?

We haven't provided guidance on the pediatric indication size as we are still evaluating it. It is small but growing, and we are continuing our assessments through the pilots we've run, which we extended into this year. As we gather more information, we will offer more detailed guidance over the year. For now, it is included in our overall guidance. I want to emphasize what Tom mentioned: we are seeing an increasing number of patients seeking care in this area. The encouraging aspect is that, as the market leader, we are capturing a larger share, with more patients turning to LINZESS due to its clinical profile, patient satisfaction, and exceptional formulary access, making it a leader in the class. This success is also reflective of the overall increase in demand as patients prioritize their care. Concerning CNP-104, congratulations to the Simon Bay team on their outstanding achievement. We entered this space because we identified an asset from both a scientific and profile standpoint that we believe extends our gastrointestinal portfolio. We see opportunity in continuing to address GI diseases, which aligns with our strategy. We find the science behind this asset and its potential to be disease-modifying particularly compelling. As Mike mentioned earlier, existing therapies primarily address the symptoms of primary biliary cholangitis (PBC), while we believe CNP-104 has the potential to halt and reverse autoimmune damage. We anticipate having more data to support our hypothesis by the third quarter of this year, which we expect to validate our position on CNP-104 as a unique asset in this market. Again, congratulations to the Simon team.

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

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

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?

Yes, I'll address the second question regarding LINZESS first, and then Mike will respond to the question about the regulatory pathway. Early signs in the pediatric space are very promising. Regarding the specific 92-microgram dose, we feel optimistic about it. We believe it represents an opportunity worth pursuing up until 2029 and justifies the investment. However, it's still too early to provide detailed guidance for this year. As we gather more information, we will share our insights, but we want to approach this cautiously given the current growth profile and its small size. Nonetheless, we are pleased with the uptake and the return on investment.

But we're not seeing a dramatic increase in our investment. I think this is maybe a refinement of our marketing mix. I mean there's no question. We're running a number of pilots, digital pilots right now, certainly sales pilots right now. We're taking a critical look at the whole Medicaid exposure piece, which has to be part of the equation with regard to where we're going to focus our activity and investment. I think we're very pleased with what we're seeing as Sravan said, but we certainly are going to be very, very disciplined with regard to how we invest our money at this point in the life cycle.

Yes, for the Apraglutide for the Phase 3, I mean, honestly, we're clearly 110% focused on the March top-line results and very much committed to that in 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 then in between that, that will all fall in as we see the date in March.

Your next question comes from the line of Tim Chiang of Capital One. Your line is open.

Mike, I wanted to ask you a couple of questions. There won't be any direct comparison data between Apraglutide and GATX, but if we look at the GATX label, that drug was approved quite some time ago. Its main efficacy endpoint is a clinical response measurement. I would like to hear your thoughts on this because, assuming you have positive data in March, will you provide information on the secondary outcome measure of at least a 20% reduction in parental support volume from baseline at weeks 20 and 24 as a relative comparison to GATX?

Yes. Thanks, Tim. So, you're exactly right, and I kind of alluded to this in my other comments, but the GATX program had a responder definition. The responder definition required a 20% reduction in parental support volume to be a responder. That actually translates quite well to the endpoint of the reduction in at least 1 day of per week. In fact, you may recall, I don't know if you're aware, but at the GATX Advisory Committee, it all came down to that - is one day a week meaningful? And does this sort of 20% relate to that, meaning a responder definition? It was a key discussion point and clearly, the advisers agreed, and it ultimately got NPS approval for GATX and short bowel syndrome requiring parenteral support. 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 volume reduction at 24 weeks as well as the one-day off endpoint, and that's how the discussions have gone with the agency. But they do very much correlate whether you take the relative change from baseline or percent change those volumes do translate pretty well. If you look at CapEx primary was a little nuance to is the percent change. They didn't use the responder definition CapEx did. But if you look at the data, it actually translates pretty well across the two studies even 10 years apart, which I found quite interesting given the nature of short bowel syndrome with intestinal failure.

That's helpful, Mike. I wanted to point out that the data we have from GATX and Glepa indicates a reduction of about 2 points or 2 liters per week in parental support needs compared to the placebo. I just wanted to confirm that if we can achieve similar efficacy, that would be considered a success, right?

Yes. Well, I think right now, I mean, you're getting to the granular volumes. But honestly, right now for us, the win 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 productively, 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 GATX and the Glepa programs. A lot of those more nuanced volume data is going to come out later because the primary top-line data usually sticks to statistically relevant endpoints from a first run perspective, and then we'll have multiple scientific sessions where we'll continue to roll out 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? Or do you think you won't make the cutoff?

The abstract deadline for this DDW was last December. There are indeed fast track points to consider. We are prioritizing statistically relevant endpoints for the top line, so expect a significant amount of data to be released later.

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.