Q4 2024 Ironwood Pharmaceuticals Inc Earnings Call
Kathleen: My name is Kathleen and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals 4th Quarter 2024 Investor Update Conference Call.
Kathleen: All lines have been placed on mute to prevent any background noise.
Kathleen: After the speaker's remarks, there will be a question and answer session. Thank you. I would now like to turn the call over to Greg Martini, Chief Financial Officer. Please go ahead.
Speaker Change: Good morning and thanks for joining us for our fourth quarter and full year 2024 Investor Update. Our press release issued this morning can be found on our website.
Speaker Change: Today's call and accompanying slides include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Speaker Change: Such statements involve risks and uncertainties that may cause actual results to differ materially.
Speaker Change: A discussion of these statements and risk factors is available on the current Safe Harbor Statements slide, as well as under the heading Risk Factors in our annual report on Form 10-K for the year ended December 31, 2023, and in our subsequent SEC filings.
Speaker Change: All forward-looking statements speak as of the date of this presentation, and we undertake no obligation to update such statements.
Speaker Change: 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.
Speaker Change: 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 gap measures.
Speaker Change: During today's call, Tom McCourt, our Chief Executive Officer, will begin with a brief overview.
Speaker Change: Mike Shetzline, our Chief Medical Officer, will discuss our pipeline, and I will provide a commercial update and review of our financial results and guidance.
Tom Mccourt: 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. Good morning, everyone, and thanks for joining us today to review the fourth quarter and full year 2024 financial results and business updates.
Tom Mccourt: We're entering 2025 with a streamlined focus on advancing apiglutide and realizing its potential to significantly expand the market in GLP-2 treated patients with short bowel syndrome who are dependent on parenteral support.
Tom Mccourt: Recent data from our Open Label Extension Study, which is called STARS EXTEND, further reinforce and strengthen our confidence in amperaglutide's potential to become Ironwood's next blockbuster therapy.
Tom Mccourt: Last month, we shared an analysis showing that 27 total patients achieved enteral autonomy, or in other words, achieved independence from parental support while on apiglutide.
Tom Mccourt: These data are important when thinking about the impact apiglutide can have in this patient population and demonstrate apiglutide's potential to provide patients with either longer periods away from or complete freedom from parenteral support.
Tom Mccourt: Building on these promising results, we're planning to include additional analysis based on exposure time.
Tom Mccourt: from the Long-Term Extension Study into our NDA submission package to support an even more robust, clinically differentiated, and comprehensive data package to the FDA.
Tom Mccourt: As we recently announced, we have initiated the rolling submission of our NDA and expect to complete submission in the third quarter of 2025.
Tom Mccourt: If approved, Epiglutide will become the first long-acting GLP-2 to market for short bowel syndrome patients who are dependent on parental support, providing a new treatment option with the convenience of once-weekly dosing.
Tom Mccourt: Aligned with this next phase of growth, we have restructured our business to focus on bringing apiglutide to market, strengthening our commitment to advancing care for patients with short bowel syndrome. We believe these changes we've made position us for future growth.
Tom Mccourt: long-term value creation, and ultimately reinforce our commitment to bringing new medicines to patients with rare disease.
Tom Mccourt: We have a strong team in place to drive the success of apiglutide if approved.
Tom Mccourt: Our commercial efforts, led by Tammy Gaskin, our newly appointed Chief Commercial Officer, and she is supported by an experienced team with expertise in key functional areas of commercialization in both GI and rare disease.
And, we're actively preparing for a potential commercial launch.
Tom Mccourt: Unlike Linzess, launching a treatment for rare disease like short bowel syndrome requires a targeted approach.
Tom Mccourt: And through our extensive market assessment, we now know that this is a much smaller, rare disease-focused prescriber base primarily located in short bowel syndrome centers of excellence, where the majority of patients are managed.
Tom Mccourt: With these insights in mind, we plan to implement a robust patient support service model, one that ensures seamless care from the point of prescription to treatment authorization, delivery, initiation, and ongoing utilization of apiglutide.
Tom Mccourt: While apiglutide is our focus for the future, Linzess remains a critical part of our portfolio, helping millions of adults with IBSC and chronic constipation.
Tom Mccourt: Even after 12 years, demand continues to grow, further solidifying Linzess as the prescription market leader.
Tom Mccourt: In the fourth quarter of 2024, we saw a 12% increase in prescription demand.
Tom Mccourt: growth compared to the fourth quarter of 2023 per IQVIA, and 11 percent prescription demand growth for 2024 year over year.
Tom Mccourt: New-to-brand volume growth was 11% for the fourth quarter of 2024 and 14% for the full year.
Tom Mccourt: This marks the eighth consecutive quarter for double-digit, new-to-brand volume growth, demonstrating that patients and providers continue to choose Linzest.
Tom Mccourt: For the full year of 2024, we achieved our latest 2024 financial guidance delivering $916 million in net sales.
Tom Mccourt: And based on IQVIA script data, we are starting to see Medicare utilization, a headwind in 2024, stabilize as a percent of our book of business in the second half of 2024.
Tom Mccourt: As we look ahead to 2025, we expect to see continued strong demand growth with LINZ-S while also anticipating pricing headwinds and therefore have a focused investment to continue to drive profits.
Tom Mccourt: We expect the cash flows from LINSES will continue to sustain future capital needs to fund the next stage of growth for Ironwood, namely the commercial approval and launch of apiglutide for short bowel syndrome patients who are dependent on parental support.
Tom Mccourt: Before I turn the call over to Mike to talk about epiglutide and short bowel syndrome in more detail, I want to take a moment to express our gratitude to our colleagues and partners in the physician, health care provider, and patient community.
Tom Mccourt: February is Rare Disease Month and as we work towards our goal of developing and commercializing life-changing therapies for patients with GI and rare diseases we also seek to increase awareness
Tom Mccourt: for the people we serve who are at the center of our work year-round.
Without your commitment, and your commitment,
Tom Mccourt: engagement, we would not have been able to run the largest ever short bowel syndrome intestinal failure trial with apiglutide.
Tom Mccourt: Short Bowel Syndrome is a devastating condition that we thank you for your trust in us as we work.
Tom Mccourt: urgently to deliver this important medicine to short bowel syndrome patients who are dependent on parental support. With that, I'll turn it over to Mike. Mike?
Thanks, Tom, and good morning, everyone.
Tom Mccourt: 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.
Tom Mccourt: I want to dive a bit deeper into the opportunity around epiglutide and the compelling data generated from the STARS Phase III clinical trial, including additional data from the open-label extension study, STARS Xtend.
Tom Mccourt: 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.
Tom Mccourt: leading to a dependence on parenteral support or the IV administration of fluid and nutrients to maintain health, growth, and survival.
Tom Mccourt: Approximately 18,000 adult patients are impacted by this disorder across the U.S., Europe, and Japan. This condition is associated with increased mortality, significant morbidity, high economic burden, and reduced quality of life.
Tom Mccourt: Intervention with parenteral support comes with its own challenges affecting quality of life.
Tom Mccourt: Parenteral support can be required for 10 hours a day and six days a week on average.
Tom Mccourt: Due to the significant patient burden, reducing the number of days and or the hours a day per week on parenteral support is extremely important to patients and their health care providers.
Tom Mccourt: Apiglutide is uniquely designed to accelerate intestinal growth for improved gut function and intestinal absorption.
Tom Mccourt: Apiglutide is the only GLP-2 analog to achieve a statistically significant reduction in weekly parenteral support volume with once-weekly dosing.
Tom Mccourt: In the STARS Phase 3 study, patients also achieved clinically meaningful parenteral support volume reductions as early as week 8.
Tom Mccourt: Additionally, as previously presented, some patients achieved two and three days off of parenteral support per week, and a portion of patients achieved enteral autonomy in the STARS Phase 3 study.
Tom Mccourt: Enteral autonomy is when individuals no longer require parenteral support, a significant life-changing milestone for patients and their families in their treatment journey.
Tom Mccourt: We're now seeing even more patients achieving enteral autonomy in our extension study, fairly, further reinforcing apoglutase clinical profile.
Tom Mccourt: As Tom mentioned, based on an analysis we shared in January, 27 total patients treated with apiglutide achieved enteral autonomy. Beyond that, we continue to see encouraging trends in parenteral spore volume reduction more broadly with longer exposure to apiglutide.
Tom Mccourt: We're excited by this growing body of clinical evidence that we believe supports apiglutide's potential, if approved, to become the first long-acting, once-weekly GLP-2 therapy for the treatment of short bowel syndrome.
Tom Mccourt: With that, I'll turn it over to Greg to review our financials. Greg? Thanks, Mike. We ended 2024 in a strong financial position, achieving our 2024 full-year guidance.
Tom Mccourt: Our business continues to be supported by strong Linzess prescription demand.
Greg Martini: We saw 11% full-year 2024 prescription demand growth and recognized 223 million dollars in Linzess U.S. net sales in the fourth quarter.
and 916 million dollars for the full year.
Greg Martini: Ironwood recorded $88.4 million in collaborative arrangements revenue in the fourth quarter of 2024 and $340.4 million for the full year.
Greg Martini: As you can see on slide 11, in 2024, Glenzeth continued to deliver strong, double-digit extended unit and new-to-brand prescription demand growth.
Greg Martini: 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 apiglutide.
Greg Martini: Turning to slide 12 to review full year 2024 financial highlights.
Greg Martini: Total revenue was $351.4 million. Gap net income was $1.8 million and adjusted EBITDA was $100.6 million, which includes stock-based compensation.
Greg Martini: As a reminder, we have provided 2025 financial guidance for adjusted EBITDA, excluding stock-based compensation expense, and will be moving to this new definition beginning in the first quarter of 2025.
Greg Martini: We ended the full year 2024 with $88.6 million of cash and cash equivalents on the balance sheet.
Greg Martini: In the fourth quarter, Ironwood repaid $15 million of debt, ending the year with $385 million drawn on our credit facility.
Greg Martini: Over the past 12 months, in the midst of pricing headwinds in 2024, Ironwood reduced its total debt balance outstanding by roughly $115 million.
Greg Martini: As of December 31st, 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.
Thank you.
Greg Martini: In 2025, we remain focused on delivering sustained profits and cash flows to fund the advancement of apiglutide and repaid debt to strengthen our balance sheet.
Moving to financial guidance on slide 13.
We are reiterating our 2025 guidance at this time.
Greg Martini: This includes U.S. LINZESC net sales between $800 and $850 million.
Greg Martini: We expect Glenz's prescription demand to remain strong with high single-digit prescription demand growth.
Greg Martini: 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 million and $290 million.
Greg Martini: As a reminder, Ironwood recognizes Collaborative Arrangement revenues from Linzess as a portion of commercial profits, which includes an add-back for Ironwood's selling and marketing expenses.
Greg Martini: 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.
Greg Martini: 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 Apriclutide in 2025, and to position the company for long-term growth.
Greg Martini: We are increasingly encouraged by the positive body of clinical evidence that we believe supports apoglutide's potential to meaningfully change the treatment paradigm for short bowel syndrome and become our second blockbuster therapy.
Greg Martini: We are working diligently to complete our NDA submission by the third quarter of 2025, and prelaunch planning is well underway to support the commercialization of apiglutide upon approval by the FDA.
Greg Martini: 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.
Greg Martini: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue.
Greg Martini: And if you would like to withdraw your question, simply press star 1 again.
Greg Martini: If you are called upon to ask your question and listening by a loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Again, please press star 1 to join the queue.
Speaker Change: And your first question comes from the line of Chase Knickerbocker of Quay Callum. Your line is now open.
Good morning. Thanks for taking our questions.
Speaker Change: Just first for me, I get it's kind of early after kind of just taking these kind of head count changes.
Speaker Change: 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, you know, virtual-based marketing, at least personally with yourselves?
Speaker Change: around kind of the confidence you have on high single-digit volume growth this year, you know, without that in-person promotion from the Ironwood side. Thanks.
Speaker Change: Tom, do you want to take that? Yeah, sure. Thanks Chase. You know, as you know, we still have a very
supporting and driving the growth of Linzess.
Speaker Change: You know, and at this point, you know, it's a lot of the consumer advertising that's probably driving the ongoing growth. Certainly, you know, when we look at ROIs, it tends to look very, very positive.
Speaker Change: And this is something, yeah, that we've continued to refine over time.
Speaker Change: If you think about where we were three and five years ago, we basically cut our selling effort more than by half.
Speaker Change: And we've also pulled back on the media buy to increase the bottom line profit of the drug.
Speaker Change: And we have not seen any evidence that demand is slowing down.
Speaker Change: And we're seeing that so far out of the gate. It's early, the numbers, as you know, don't always line up year over year.
Speaker Change: But, you know, we're still seeing very, very strong momentum, you know, on the brand. And I think as long as we can maintain broad payer access, I don't see that slowing down. You know, when you have a brand in a market that has almost 50 percent market share,
Speaker Change: It's really hard for an emerging competitor to really capture share around you or away from you.
Speaker Change: 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.
Speaker Change: and we'll be certainly watching, you know, what's going on with our payer mix.
Speaker Change: to really better understand what kind of exposure we have as the year goes on. But I think, you know, we feel very confident in the guidance we've given that, you know, it's very achievable and hopefully, you know, we'll do everything we can to exceed it.
Greg Martini: That's great, Tom. Thanks. And, Greg, maybe just a couple on the model.
Greg Martini: First, if we think about kind of the cadence of cost saving, should we be kind of assuming that
Greg Martini: You know, Q1 has a fairly full kind of recognition, at least on a run rate basis, of kind of those cost savings.
Greg Martini: And then just second, on the R&D line, as these kind of, you know, trial activities start to roll off, I mean, when should we be kind of modeling a decrease in R&D? Is it, you know, back up at 25? Is it at 26? Just help us think about expenses.
Greg 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,
Greg Martini: Really, R&D for 2025, I would not expect to see a decline really year over year, specifically with apiglutide and 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.
Greg Martini: The 2026 is where we would start to see some of that inflection in terms of overall R&D spend. We'll provide more details on that as we get closer to 2026.
Speaker Change: 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...
Speaker Change: We're seeing ongoing reduction in parental support and even enteral autonomy. So, you know, I think this is a really solid investment for us.
Speaker Change: 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.
Speaker Change: Got it. Then just last thing from me, Greg, and I'll hop back in queue, but can you just kind of speak to the confidence around, you know, maintaining compliance on the covenants around the revolver? And it gets, you know, 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 add-backs if you'd oblige us. Thank you.
Yeah.
Yeah, absolutely. Thanks, Jess.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: But there are other ad backs and I can't necessarily go through all of them in detail But there are other ad backs that do give us additional room and comfort with being able to achieve those covenant
Speaker Change: 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.
Thanks, guys.
Speaker Change: Your next question comes from the line of Jason Butler of Citizens JMP. Please go ahead.
Hi, thanks for taking the question.
Jason Butler: just had one on the long-term data for apiglutide. Can you maybe speak to the patient characteristics of those patients reaching or achieving enteral autonomy? I guess, were you seeing this from both CIC and stoma patients?
Jason Butler: And then, how does this compare to the double-blind period of the study, where I think it was about seven patients achieved enteral autonomy? Have any of those patients, you know, maintained enteral autonomy for the entire period? Thank you.
Thank you.
Yeah, thanks.
Jason Butler: 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 three program in SPSIF. So it's SPSIF as you know is a very heterogeneous
Jason Butler: syndrome, patient disease. So having that large patient population really gives us an opportunity to look at a broad spectrum of patients.
Jason Butler: and their outcomes. And if you, to direct your question to the enteral autonomy, we certainly are seeing patients achieve enteral autonomy on both stoma and CIC.
Jason Butler: 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.
Jason Butler: In all of the secondaries, we presented some of this data last year, too. In all the secondaries that look at subpopulations across the SPSIF,
Jason Butler: we really do always see a numerical benefit with apiglutide. 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.
Jason Butler: In terms of the double-blind data, you probably recall that initially we saw enteral autonomy achieved at 24 weeks, and that actually included stoma patients as well.
Jason Butler: And then by the end of 48 weeks, we had roughly 10 patients achieve enteral autonomy.
Jason Butler: The 27 comes from adding in the STARS XTEND data, which is the O12 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 comparator products in terms of how many patients are achieving enteral autonomy. And the patients who achieved enteral autonomy in the double-blind period
Jason Butler: carry on into the Extension program. So we're really seeing good fidelity, and once patients achieve intra-autonomy, they maintain it.
Great, thank you for taking the question.
Thank you.
Speaker Change: Your next question comes from the line of Amy Lee of Jeffries. Please go ahead.
Speaker Change: Hi, this is Cassie 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?
Thank you.
Speaker Change: Yeah, thanks Kathy 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.
Speaker Change: 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
the trends and the expectations we have for the year.
Okay, great. Thank you.
Speaker Change: Your next question comes from the line of Faisal Kursid of Fleering Partners. Please go ahead.
Speaker Change: Hi, guys. This is Matt Calperon for FESL. Thanks for taking my questions. Just a couple for me. How should we be thinking about the launch expenses for Apple Glutide, both in terms of magnitude and timing? And what levels are contemplated in the 2025 adjusted EBITDA guide? And then second question, just what options exist around the 2026 convert? And how is the company thinking about managing that? Thank you.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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,
Speaker Change: 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.
Speaker Change: with the intent 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.
Got it. Thank you.
Speaker Change: Your next question comes from the line of David Amsalem of Piper Sandler. Please go ahead.
David Amsalem: 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.
Sravan Emany, Thomas McCourt, Michael Shetzline
Speaker Change: As we move forward, we'll continue to evaluate other alternatives to really prioritize investments focused on those in need.
investments we think will drive the best long-term value.
Speaker Change: and that includes the Ironwood P&L as well as the overall Linzess brand investment.
Speaker Change: in conjunction with AbbVie. 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 and beyond.
Okay, thank you.
Speaker Change: Ladies and gentlemen, that concludes our Q&A session and today's call. Thank you everyone for joining. You may now disconnect.
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