Yahoo Finance

Mike Shetzline

Thanks, good morning, everyone. We're pleased to have initiated our rolling NDA submission earlier this year, which we expect to be completed in the third quarter of 2025. I want to dive a bit deeper into the opportunity around apraglutide and the compelling data generated from the Stars phase three clinical trial, including additional data from the Open label extension study STARS Extend.
Short bowel syndrome with intestinal failure results from severe organ failure due to a reduction in intestinal function below the minimum necessary for adequate nutrition and fluid absorption, leading to a dependence on parenteral support or the IV administration of fluid and nutrients to maintain health, growth, and survival.
Approximately 18,000 adult patients are impacted by this disorder across the US, Europe, and Japan. This condition is associated with increased mortality, significant morbidity, high economic burden, and reduced quality of life. Intervention with parental support comes with its own challenges affecting quality of life.
Parentoral support can be required for 10 hours a day and six days a week on average.
Due to the significant patient burden, reducing the number of days and or the hours a day per week on parental support is extremely important to patients and their healthcare providers. Apraglutide is uniquely designed to accelerate intestinal growth for improved gut function and intestinal absorption.
Apraglutide is the only GLP-2 analog to achieve a statistically significant reduction in weekly parental sport volume with once weekly dosing.
In the STARS Phase 3 study, patients also achieved clinically meaningful parental support volume reductions as early as week eight. Additionally, as previously presented, some patients achieved two and three days off of parental sport per week, and the portion of patients achieved enteral autonomy in the STARS Phase 3 study.
Enteral autonomy is when individuals no longer require parental support, a significant life changing milestone for patients and their families in their treatment journey. We're now seeing even more patients achieving enter autonomy in our extension study, fairly further reinforcing Aroglutide's clinical profile.
As Tom mentioned, based on an analysis we shared in January, 27 total patients treated with aproglutide achieved enteral autonomy. Beyond that, we continue to see encouraging trends in parental sport volume reduction more broadly with longer exposure to aproglutide. We're excited by this growing body of clinical evidence that we believe supports apraglutide's potential if approved to become the first long acting once weekly GLP-2 therapy for the treatment of short bowel syndrome.
With that, I'll turn it over to Greg to review our financials, Greg.

Gregory Martini

Thanks, Mike. We ended 2024 in a strong financial position, achieving our 2024 full-year guidance. Our business continues to be supported by strong LINZESS prescription demand.
We saw 11% full year 2024 prescription demand growth and recognized $223 million in LINZESS US net sales in the fourth quarter and $916 million for the full year.
Ironwood recorded $88.4 million in collaborative arrangements revenue in the fourth quarter of 2024 and $340.4 million for the full year.
As you can see on slide 11 in 2024, LINZESS continued to deliver strong double digit extended unit and new to brand prescription demand growth. The continued strong prescription demand growth bolsters our confidence in the strength of LINZESS over time and the expectation that LINZESS will drive meaningful cash flows moving forward to fund the next stage of growth through the advancement of apraglutide.
Turning to slide 12 to review full year 2024 financial highlights.
Total revenue was $351.4 million GAAP net income was $1.8 million and adjusted EBITDA was $100.6 million which includes stock-based compensation. As a reminder, we have provided 2025 financial guidance for adjusted EBITDA excluding stock-based compensation expense. And we'll be moving to this new definition beginning in the first quarter of 2025.
We ended the full year 2024 with $88.6 million of cash and cash equivalents on the balance sheet. In the fourth quarter, Ironwood repaid $15 million of debt, ending the year with $385 million drawn on our credit facility.
Over the past 12 months, in the midst of pricing headwinds in 2024, Ironwood reduced its total debt balance outstanding by roughly $115 million. As of December 30th, 2024, Ironwood had access to roughly $254 million in liquidity between the $88.6 million of cash on hand and $165 million undrawn revolver capacity.
In 2025, we remain focused on delivering sustained profits and cash flows to fund the advancement of Aroglutide, and repay debt to strengthen our balance sheet.
Moving to financial guidance on slide 13. We are reiterating our 2025 guidance at this time. This includes US Linnet sales between $800 million and $850 million. We expect LINZESS prescription demand to remain strong with high single digit prescription demand growth.
This strong demand growth is expected to be more than offset by pricing headwinds associated with the Medicare Part B redesign that went into effect earlier this year. We expect Ironwood revenue between $260 and $290 million.
As a reminder, Ironwood recognizes collaborative arrangement revenues from LINZESS as a portion of commercial profits, which includes an ad back for Ironwood selling and marketing expenses. And we expect adjusted EBITDA excluding stock-based compensation of greater than $85 million which reflects a roughly $55 million decrease from 2024 operating expenses, primarily within SG&A driven by the reorganization actions announced last month.
In summary, we have taken actions to continue to generate profits and cash flows, pay down debt, strengthen our balance sheet, and support the advancement of Aroglutide in 2025, and to position the company for long-term growth.
We are increasingly encouraged by the positive body of clinical evidence that we believe supports aroglutide's potential to meaningfully change the treatment paradigm for short bowel syndrome and become our second blockbuster therapy.
We are working diligently to complete our NDA submission by the third quarter of 2025, and pre-launch planning is well under way to support the commercialization of apoglutide upon approval by the FDA.
I want to close by thanking all of our employees, patients, caregivers, and advocates for their shared dedication to advancing life changing therapies for patients with GI and rare diseases. Operator, you may now open the line for questions.

Question and Answer Session

Operator

Thank you. We will now begin the question and answer session.(Operator Instructions)
Chase Knickerbocker, [Quay Callum].

Chase Knickerbocker

Oh, good morning. Thanks for taking our questions. Just first for me, I get it, it's kind of early after kind of just taking these kind of headcount changes, but can you kind of just speak to the confidence you have in any kind of initial kind of learnings now that you've kind of went to more, virtual based marketing at least personally with yourselves around kind of the confidence you have on high single digit volume growth this year, without that in-person promotion from the Ironwood side. Thanks.

Thomas McCourt

Yeah. Sure, thanks, Chase. As we still have a very solid marketing mix supporting and driving the growth of LINZESS. We still have a number of AI sales personnel in the really the key offices, and at this point, it's a lot of the consumer advertising that's probably driving the ongoing growth. Certainly, when we look at ROIs, it tends to look very positive. And this is something that we've continued to refine over time. You think about where we were three or five years ago, we basically cut our selling effort more than by 50%, and we've also pulled back on, the media buy to increase the bottom line profit of the drug, and we have not seen any evidence that demand is slowing down and we're seeing that so far out of the gate. It's early. The numbers, as don't always line up year over year.
But we're still seeing very strong momentum, on the brand, and I think as long as we can maintain broad payer access, I don't see that slowing down, when you have a brand in a market that has almost 50% market share. It's really hard for an emerging competitor to really, capture share around you and away from you, and we're actually continuing to see either maintaining or increasing our market share even in the face of multiple competitors over the last four or five years. So I think we feel very confident in the single digit demand growth.
And we'll be certainly watching, what's going on with our payer mix to really better understand what kind of exposure we have as the year goes on, but I think, we feel very confident in the guidance we've we've given that you know it's very achievable and hopefully we'll do everything we can to exceed it.

Chase Knickerbocker

That's great, Tom, thanks. And Greg, maybe just a couple on the model. First, if we think about kind of the cadence of cost savings, should we be kind of assuming that, one has a fairly full kind of recognition, at least on a run rate basis of of kind of those cost savings and then just second on the R&D line as these kind of, trial activities start to roll off. I mean when should we be kind of modeling a decrease in R&D. Is it, back up at '25, is it '26, just help us think about expenses.

Gregory Martini

Yeah, thanks, Chase. In terms of the cost savings actions that were taken last month, first quarter, we won't see the full impact because these actions were taken at the end of January. So you'll really start seeing that full run rate in Q2 for the rest of the year.
And then as you think about R&D, really R&D for 2025 would not expect to see a decline really year over year, specifically with apraglutide in the ongoing extension study. And also some of the CMC activities that we're continuing to complete as we move forward and prepare for a commercial launch.
The 2026 is where we would start to see some of that inflection in terms of overall R&D spend. And we'll provide more details on that as we get closer to two.

Thomas McCourt

I think it's important to mention Chase too on the long term extension, as Mike mentioned earlier, I mean, as we continue to actively follow these patients, we're seeing ongoing reduction in parental support and even enter autonomy.
So you know I think this is a really solid investment for us to really further understand the potential benefit that these patients can occur over time. And certainly you know that obviously strengthens the overall profile of the drug.

Chase Knickerbocker

Got it. And then just last thing from me, Greg, and I'll hop back in cue, but can you just kind of speak to the the confidence around, maintaining compliance on the covenants around the revolver and and it gets, a little bit complex. I think it would be kind of helpful to kind of walk through a little bit of the kind of detailed math on kind of some of those ad backs if if if you'd oblige us.
Thank you.

Gregory Martini

Yeah, thanks. I think just broadly speaking, we have a high degree of confidence in our outlook of 2025 with our financial guidance, we will be able to continue to maintain covenant compliance throughout the year and have a very high degree of confidence there. We did adjust the adjusted EBITDA definition.
As I noted in the prepared remarks, to give a little bit more clarity about some of the key adjustments we have with those debt covenants, specifically with stock-based compensation. But there are other adbacks, and I can't necessarily go through all of them in detail.
But there are other adbacks that do give us additional room and comfort with being able to achieve those covenant amounts for our debt throughout 25, and it's something we're very much focused on and very focused on disciplined expense management to continue to drive profits and cash flows with those covenants in mind.

Operator

Jason Butler, Citizens JMP.

Jason Butler

Thanks for taking the question. Just had one on the long term for.
Can you speak to the patient characteristics of those patients reaching or achieving enter autonomy, I guess were you seeing this from both CIC and stoma patients, and then how does this compare to the double-blind period of the study where you, I think it was about seven patients achieved enteral autonomy. Have any of those patients, maintained enter autonomy for the entire period? Thank you.

Mike Shetzline

Yeah, thanks, Jason. Thanks for your question. So in terms of the patients achieving enteral autonomy, we really benefit from the fact that we have completed the largest ever done Phase 3 program in SBS-IF. So it's SBS-IF as is a very heterogeneous, syndrome patient disease.
So having that large patient population really gives us an opportunity to look at a broad spectrum of patients. And their outcomes and if you to direct your question to this enteral autonomy, we certainly are seeing patients achieve enter autonomy on both stoma and CIC.
We'll actually roll out the details on the whole population. That's one of the things we're putting together for this submission because we know that's an important question for all of us in terms of understanding the critical benefit to this patient population. And it's fair to say that it is in all of the secondaries we presented some of this data last year too in all the secondaries that look at subpopulations across the SBS-IF, we really do all we see a numerical benefit with apraglutide. So we really do think the patient population that we're targeting is the right one, meaning the broad patient population with short bowel syndrome and intestinal failure. In terms of the double blind data, you probably recall that initially we saw enter autonomy achieved at 24 weeks, and that actually included stoma patients as well.
And then by the end of 48 weeks we had roughly 10 patients achieve enter autonomy. The 27 comes from adding in the star's extend data, which is the o'12 study, which is the extension study. And that Brought that number up obviously to a very meaningful number of 27. Which really in aggregate is a pretty robust outcome if you look at other comparative products in terms of how many patients are achieving, enter autonomy, and the patients who achieved enter autonomy in the double blind period carry on into the extension program. So we're really seeing good fidelity and once patients achieve enter autonomy they maintain it.

Jason Butler

Great. Thank you for taking the question.

Operator

Amy Li, Jefferies.

Amy Li

Hi, this is Kathy on for Amy. Congrats on the quarter. So I guess I was wondering, as we think about the timing of the Medicare Part D redesign impact, is it fair to assume that the impact to LINZESS revenues won't be until the second half of 2025 since LINZESS is low cost and it takes time for patients to get into catastrophic coverage?

Gregory Martini

Yeah, thanks, Cathy, for the question. I think the key for us is our full year guidance obviously takes into account our expectations for this redesign for the full year. I think there is an element of timing here where we will have to see how prescription demand trends and ultimately the tiering within Medicare Part D plays out over the course of the year.
So I do think each quarter we move forward we'll have better insights into what the potential price exposure is, but we feel very confident that our guidance range appropriately accounts for the trends and the expectations we have for the year.

Amy Li

Okay, great. Thank you.

Operator

[Pitakar Seat], Leerink Partners.

Pitakar Seat

Hi guys, this is Matt Calperon for Pythaler. Thanks for taking my questions. Just a couple for me. How should we be thinking about the launch expenses for apraglutide both in terms of magnitude and timing and what levels are contemplated in the 2025 adjusted eBay guide, and then second question just what options exist around the 2026 convert and how is the company thinking about managing that?

Gregory Martini

Thank you. Thanks, Matt. I can take both of those. In terms of the commercial launch expenses, we have been working on commercial planning activities from 2024. And we'll continue that into 2025. I would say at this point they are not significant expenses within the overall P&L. And we would expect to see a bit of a ramp up as we get closer to launch in 2026, and we'll provide additional details on exactly what that spend looks like as we get closer to that timing.
And then in terms of the 2026 convertible notes, this is something that we continually evaluate our capital structure in the context of our overall forecast and outlook, and we are very much focused throughout 2025 on strengthening our balance sheet with the And on driving profits and cash flows to repay our existing debt and so we'll provide additional details as we make decisions on any further actions on our balance sheet, but at this point I really want to focus on driving cash flows to repay our outstanding debt.

Pitakar Seat

Got it, thank you.

Operator

David Amsellem, Piper Sandler.

David Amsellem

Hey thanks. I joined late, so maybe you already addressed this, but can you just talk more broadly about the cost structure? It's not so much about your ability to launch apraglutide. But the extent to which you can extract more savings. I know you had the recent restructuring, but maybe talk more about how you're thinking about further streamlining just given the state of the capital structure. Thanks.

Gregory Martini

Yeah, thanks, David. In terms of cost structure, I think we feel very good about our outlook, as I mentioned, in terms of 2025 and the actions we've taken to really focus on profits and cash flows in '25.
As we move forward, we'll continue to evaluate other alternatives to really prioritize investments focused on those. We think will drive the best long term value and that includes the Ironwood P&L as well as the overall brand investment in conjunction with that. So at this point I think we've communicated everything that we can at this time on what we plan to do for '25 and we'll continue to evolve that as we move forward in '26.

Operator

Okay, thank you. Ladies and gentlemen, that concludes our Q&A session and today's call. Thank you everyone for joining. You may now disconnect.