IRONWOOD PHARMACEUTICALS INC(IRWD)Q2 2026 法說會逐字稿

Good morning, everyone. My name is Ian, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Q2 2026 Investor Update Conference Call. I would like to now turn the call over to Chris Stamm, VP, Investor Relations and Communications. Please go ahead.

Good morning and thanks for joining our second quarter 2026 investor update. A press release issued this morning highlighting Q2 results can be found on our website. Today's call and accompanying slides include forward-looking statements within the meanings of the Private Securities Litigation Reform Act of 1995. 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 slide as well as under the heading Risk Factors in our Annual Report Form 10-K for the year ended December 31, 2025, and in our subsequent SEC filings. All forward-looking statements speak as of the date of this presentation, and 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 review second quarter business highlights and strategic priorities. After Tom, Chief Commercial Officer Tammi Gaskins will provide an overview of second quarter LINZESS performance. Next, Jeff Silber, our newly appointed Chief Medical Officer and Head of Research and Drug Development, will give a brief update on apraglutide. Then Ron Silver, our Interim Chief Financial Officer, will close our prepared remarks with a financial update before we open the call for questions. Jeff Ruberti, our Chief Strategy Officer, will also be available for the Q&A at the end of the call. Today's webcast includes accompanying slides. For those joining by phone, please visit the events section of our website to access the presentation. And with that, I'll turn the call over to Tom.

Thanks, Chris. Thanks, everyone, for joining us to review Ironwood's second quarter 2026 financial results and business update. Before I begin, in addition to welcoming Chris, who joined the team in June to lead our IR and communications efforts, I'd like to introduce 2 recent additions to the Ironwood leadership team, who you'll be hearing more from today and in the weeks and months ahead. But first, I want to sincerely thank former Chief Medical Officer and Head of R&D, Michael Shetzline, who retired after a distinguished career dedicated to advancing GI science and patient care. Most recently, he led the team through a major company milestone, successful initiation of the confirmatory Phase III STARS-2 trial. Last month, we welcomed Dr. Jeff Silber, Mike's successor, who brings more than 30 years of experience in the industry and academia. Jeff is an accomplished leader in drug development from preclinical through submission, commercialization, and expanding value of brands through lifecycle management. Previously Chief Medical Officer at Vedanta Biosciences, he brings broad late-stage development expertise to Ironwood, having supported multiple successful new drug applications and valuable brands in leadership roles at AbbVie, EMD Serono, Merck KGaA, and Merck & Co. His leadership will be instrumental as we advance apraglutide through Phase III and commercialization. I'd also like to introduce Ron Silver, our Senior Vice President, Corporate Controller, and Chief Accounting Officer, who is serving as Interim Chief Financial Officer. Ron has been with Ironwood for 8 years, serving in key financial leadership roles, providing him with deep knowledge of our business and strategy. His experience and leadership will be invaluable as we continue to execute against our priorities. Now, let's dive into the second quarter business updates. At the beginning of the year, we outlined three key priorities for 2026: maximizing the performance of LINZESS, advancing apraglutide, and delivering sustained profitability and cash flow. These priorities remain central to achieving our mission to redefine standard of care for patients living with gastrointestinal and rare disease while creating long-term shareholder value. During the second quarter, we made meaningful progress across each priority. Starting with LINZESS, the brand continues to demonstrate exceptional strength in its 14th year on the market and remains the prescription leader in both irritable bowel syndrome with constipation and chronic idiopathic constipation. We're pleased to report a second consecutive quarter of strong LINZESS performance, delivering $282.3 million in U.S. net sales fueled by improved net price and mid-single-digit prescription demand growth. This outstanding performance supported our decision to raise our full-year 2026 financial guidance. Based on the updated outlook, LINZESS is positioned to grow more than 30% year-over-year, return to blockbuster status, and deliver the highest annual U.S. net sales in the product's history. We also achieved an important regulatory milestone during the quarter, with the FDA approval of LINZESS for the treatment of functional constipation in pediatric patients 2 years of age and older. This is another important milestone, establishing LINZESS as the only prescription therapy approved for functional constipation in this age group, addressing yet another unmet patient need. Turning to apraglutide, in June we initiated the STARS-2 confirmatory Phase III clinical trial evaluating apraglutide in adults with short bowel syndrome with intestinal failure, or SBS-IF. The trial is now actively recruiting patients, and we continue to activate additional sites to drive enrollment. STARS-2 will build on the positive data from the Phase III STARS trial, which we believe demonstrates that apraglutide has the potential to be a best-in-class therapy for patients with SBS who are dependent on parenteral support. Our goal is to ensure apraglutide will be the first long-acting GLP-2 analog to market. Finally, we delivered strong financial results during the quarter, generating $51.3 million in GAAP net income and $83 million in adjusted EBITDA. We've also repaid our $200 million convertible notes at maturity with cash on hand. Looking ahead, we expect to leverage LINZESS generating cash flow to further reduce our debt, and we are well positioned to end 2026 with a gross leverage below 1x, while maintaining resources necessary to advance and prepare for the potential commercialization of apraglutide. With that, I'll turn the call over to Tammi to provide some additional context on LINZESS. Tammi?

Thanks, Tom, and good morning, everyone. As Tom just stated, LINZESS delivered another strong quarter with U.S. net sales of $282.3 million. That's a 14% year-over-year increase driven by both demand growth and improved net price. Now, through the first half, LINZESS U.S. net sales reached $555 million, up 44% year-over-year, underscoring the strength and momentum of the brand. Now, if I just double-click for a minute on demand, the slide you see shows year-on-year EUTRx volume growth of 4% for quarter 2 and 5% year-to-date June. We expect this demand momentum to persist and anticipate mid-single-digit demand growth for the full year, giving us the confidence to raise our full-year financial guidance. Turning to price, the positive impact seen in Q1 from elimination of inflationary rebates across channels continued to benefit net price as planned, in addition to favorable timing of gross-to-net rebate reserves as compared to the second quarter of 2025. Our full-year net sales guidance reflects the ongoing benefit of improved net price, combined with anticipated reduced variability in sequential quarterly U.S. net sales as compared to 2025, really due to more consistent net price across channels. To that end, since demand volume is historically highest in the second half of the year, we expect quarterly performance to build, with the fourth quarter projected to deliver the highest net sales for 2026. This performance also highlights the significant unmet needs that LINZESS helps to address for millions of patients with IBS-C and CIC across the U.S. And the recent FDA approval for FC, functional constipation, down to 2 years of age further expands the reach of LINZESS and helps highlight its importance for a broader range of patients. Now I'd like to hand the presentation over to Jeff Silber to highlight our progress advancing apraglutide.

Thanks, Tammi, and good morning, everyone. I'm excited to be joining the Ironwood team at such an important time to work to bring apraglutide to patients suffering from SBS-IF as quickly as possible. Today, I'd like to share my perspective on why the science behind apraglutide and what it could mean for patients is so compelling. There's a considerable unmet need for patients with SBS-IF. On average, these patients require parenteral support, that is, IV fluids and nutrients, 10 hours per day, 6 days per week, creating a real burden to their quality of life. Although parenteral support meets the nutritional needs that enable them to survive, patients continue to face many significant daily challenges. As highlighted in the landmark HCP survey that Ironwood presented at DDW last May, central line infections, fatigue, central line pain, and abdominal pain are all common and highly distressing challenges associated with parenteral support. These findings underscore the need for therapies that reduce patients' IV dependence and the associated burden of parenteral support while improving their quality of life. One of the reasons I'm so excited to have joined Ironwood is the opportunity to help advance a therapy with the potential to address this significant unmet medical need. First, apraglutide is currently the only once-weekly GLP-2 analog with positive Phase III efficacy and safety data in adults with SBS-IF. Data from the STARS study, the largest Phase III clinical trial in SBS-IF conducted to date, demonstrated significant reductions in parenteral support requirements compared with placebo at week 24, with treatment effects observed as early as week 8. As you can see in the graph on the left, at week 24 in the overall population, the reduction in weekly parenteral support volume in the apraglutide group was more than double that of the placebo group. In addition, a significantly greater proportion of patients receiving apraglutide were able to reduce their dependence on parenteral support by at least 1 day per week. Importantly, apraglutide was well-tolerated in the STARS study with an overall safety and GI tolerability profile that was similar to that of placebo. The graph on the right comes from our Phase III long-term extension study, STARS-Extend. About 90% of the patients enrolled in the STARS trial rolled over into STARS-Extend, and the majority remained on treatment at the time of the analysis shown here. These longer-term data show that patients achieve further reductions in their parenteral support requirements with continued exposure to apraglutide. This translates into more patients achieving additional days off of parenteral support, with some reaching enteral autonomy, which is the ultimate goal for patients with SBS-IF. In fact, more than 1 in 5 patients enrolled in STARS-Extend had achieved enteral autonomy as of January. We look forward to sharing additional STARS-Extend updates in the future. The clinical profile we have observed to date reflects apraglutide's best-in-class, differentiated molecular design, differentiating it from both native GLP-2 and other GLP-2 analogs. Apraglutide is long-acting, enabling convenient once-weekly dosing, and it's demonstrated a favorable tolerability profile that may support better treatment adherence. This is an important point because maintaining patients on therapy is a key factor in achieving full treatment benefit, including meaningful and sustained reductions in parenteral support. When you put all this together, the clinical evidence, the favorable tolerability, and the convenience of once-weekly dosing, we believe that apraglutide has the potential to become the preferred GLP-2 treatment option for patients with SBS-IF, which we expect to expand the number of patients who may benefit from GLP-2 therapy. Looking into the future, a uniquely differentiated GLP-2 analog like apraglutide has the potential to restore intestinal function in patients with other types of GI compromise beyond SBS-IF. Today, however, our top priority is advancing apraglutide to patients with SBS-IF as quickly as possible. And to that end, the confirmatory Phase III STARS-2 trial was initiated in June as planned and is now actively recruiting patients. STARS-2 is a 24-week global randomized double-blind placebo-controlled trial. The primary endpoint is relative change from baseline in actual weekly parenteral support volume at week 24. As we continue to add clinical trial sites, we'll be leveraging the infrastructure and the relationships that we developed during the conduct of the STARS study. As a reminder, the Phase III STARS study was the largest SBS-IF trial conducted to date, with 68 global sites. We're building on that strong foundation, leveraging those existing site relationships and adding new high-potential sites, including more sites in the U.S., and identifying opportunities to accelerate enrollment. Successful execution of STARS-2 remains one of our highest priorities for Ironwood. And site activation continues. We expect enrollment to build, and we're evaluating opportunities to accelerate the enrollment timeline. We look forward to updating you on our progress in the coming months. In summary, if approved, we believe apraglutide's differentiated clinical profile, once-weekly dosing, and long-term data position it to meaningfully improve the treatment landscape for patients with SBS-IF. With that, I'll pass the call to Ron.

Thanks, Jeff. Thanks, Tom, for the introduction. I'm pleased to have the opportunity to join the call today and look forward to working closely with our investors and analysts as we continue to advance our strategic priorities, focus on financial discipline and operational excellence. Turning to our financial results. During the second quarter, total revenue was $113 million, GAAP net income was $51 million, and adjusted EBITDA was $83 million. We ended the quarter with $79 million in cash and cash equivalents and $113 million in collaboration receivables. As Tom mentioned, we repaid our convertible notes at maturity in June. Looking ahead, we intend to continue using operating cash flows to further reduce our debt balance. Based on our current outlook, we expect to end the year with less than $300 million of gross debt outstanding, further strengthening our balance sheet and financial flexibility. Now turning to guidance. Given the continued strength of LINZESS and our very strong first half performance, I am pleased to share that we are increasing our full year of 2026 guidance. We now expect LINZESS U.S. net sales of between $1.15 billion and $1.20 billion, representing a greater than 30% increase year-over-year. This increase is driven by significantly improved net price and mid-single-digit LINZESS prescription demand growth. Our revenue guidance has increased to between $460 million and $485 million, and we expect adjusted EBITDA of greater than $310 million. This increase in our guidance reflects both the strength of our underlying business and our confidence in continued execution on our priorities throughout the remainder of the year. Now I'd like to turn the call back over to Tom for some closing remarks.

Thanks, Ron. In summary, the second quarter was marked by strong commercial execution of LINZESS, continued advancement of apraglutide with the initiation of STARS-2, and meaningful progress towards strengthening our balance sheet. Throughout the second half of the year, we will remain laser-focused on executing on our strategic priorities and advancing our vision to redefine standard of care for patients living with GI and rare disease. Before I turn it over to Q&A, I would like to thank our employees, patients, caregivers, investigators, and advocacy partners for their continued commitment and support. Operator, we're now ready to open up the line for questions.

Our first question comes from Jason Butler from Fergusons.

It's Jason Butler from Citizens. Thanks for taking the questions. Just a couple for me. First, I know one question at the beginning of the year was, would there be an impact on demand from the net price change? It seems like you have an increased comfort level that isn't going to happen now, even on a delayed basis. Can you just walk us through those dynamics?

Hi, Jason, it's Tammi. Appreciate the question. So as I stated, through June we are tracking to 5% year-to-date EUTRx volume demand growth, which is modestly ahead of what we had shown or indicated early in the year, which was low single-digit demand growth. And based on where we are in the year and the fact that historically our performance from a demand perspective even further increases in the second half of the year, that has given us the confidence and the belief to raise the demand number to mid-single-digit. We did indicate previously that we thought there could be some demand softening due to the elimination of the inflationary rebates across channels. We've done a lot working with our partner to really help ensure ongoing access for patients across channels, and we think we're in a very good spot now to deliver in that mid-single-digit range to the full year.

Great. And then second one for me just starts to understand you're still relatively early here in the trial, but can you just walk us through how site onboarding is going and then just the comments you made about potentially impacting or improving enrollment timelines. Can you just give us a little more detail about what your strategies could be there? Thank you.

Yes, absolutely, Jason. This is Jeff Ruberti. I'll open the response, but as you noted, it's early days. We initiated the trial in June and we have our first sites activated and enrolling patients. And the full weight of the company is really pressing behind, ramping up the trial, activating more sites, and we look forward to providing more operational details. As you noted, Jeff Silber just joined the team and it is a priority as well. And Jeff, do you want to comment on how can we accelerate the timeline?

Sure. It's week three and so, I am working with the team and what's impressed me so far is the diligence with which the team is executing on the plan that had been laid out over the last several months. I am just now beginning to look through this with a fine-tooth comb. We'll be looking for opportunities to accelerate and look forward to executing optimally on the plan that had already been developed.

Yes, I think the big thing here, Jason, is the expansion of the number of sites, particularly in the U.S. where we were with STARS. As you recall, there weren't many U.S. sites; it was largely ex-U.S. We see a real opportunity here. That's built on strong support from our steering committee, the scientific steering committee, who are many of the key investigators around the country, and our ability to identify high-potential sites where we know patients exist. With our trial design and the clinical profile of the drug, we're confident we can bring in a number of patients fairly quickly. We'll be updating you and the rest of the investment community as we progress through that process.

Our next question comes from the line of Mohit Bansal with Wells Fargo.

Great, thank you very much for taking my questions and congrats on all the progress. I have two questions, one on apra and one on LINZESS. For LINZESS, there has been some concern that higher prices could create issues for payer plans and affect the Medicaid patient population. Are you seeing any evidence of that in the Medicaid population? So far it doesn't seem to be the case, but we'd appreciate your comments. For apra, now that you are expanding to new sites, how will you prevent the trial conduct issues seen last time when patients were not dosed properly, and how will you ensure that does not happen again as you add more sites?

Tammi, do you want to take the first question on this?

Yes, sure. Hi, Mohit. It's Tammi, and I appreciate the question. So, you're absolutely correct in that before we had talked about, and part of the reason we indicated low single-digit demand growth at the beginning of the year is through the elimination of the inflationary rebates across channels, including Medicaid, we thought there could be some demand softening. But based on where we are at the year, the 5%, and the fact that we have done, as I mentioned, a lot with our partners, to work with the states individually to help ensure ongoing access to those patients, we are now very confident in that mid-single-digit expectation for that mid-single-digit demand growth through the rest of the year, especially since historically our demand has a bit of a seasonality and increases towards the latter half for the year, especially in Q4.

Just to be clear on kind of this issue or concern that we had at dose. As you recall, with the original trials, the STARS trial, the intent was to deliver a 5-milligram dose. Unfortunately, due to the kit and the instructions, what we actually saw was a delivery of 3.5 milligram. Now, clearly the drug worked and was extremely well-tolerated, even at 3.5 milligram. So what we wanted to do was match that so we could leverage the great data of STARS with this smaller confirmatory dose. Now, what we've done since then, based on the root cause analysis on the delivery, we've dramatically improved the kit to avoid any kind of errors in instruction or implementation of the new kit. We've done several human factors studies around that. We've also done drug exposure and pharmacokinetic data. So we're absolutely confident that we're in complete control of the dose and we're absolutely confident that this error will not happen in STARS-2. So I think moving forward, we see a very, very high probability of success to reconfirm the great data we saw in the original STARS trial.

Our next question comes from the line of Dominic Rose with Intron Health.

I've got 2. My first question is both Q1 and Q2 saw favorable time phasing of gross-to-net rebate reserves. Do we expect this to unwind in H2 or would there be more favorable moves? Is there anything you can tell us about that? And my second question is in May you flagged that Medicaid would be most likely seeing reduced volume growth in H2. Is that still your expectation now, given the guidance upgrade?

Thanks, Dominic. Tammi, do you want to take both of those?

Sure. I appreciate the question. This is Tammi. To start with the favorability of phasing of gross-to-net reserves, we do expect less variability in sequential quarterly net sales this year. We had quite a bit of variability last year for two key reasons. First, there was more difference in net price across channels. Second, because we accrued rebates relative to actual demand dispensed in a quarter, that variability in price was amplified by seasonality in certain sectors of the business. This year, net price should be more consistent across channels and will not be affected nearly as much by seasonality and actual units dispensed. We also expect to see quarter-on-quarter increases in performance, with Q4 being the strongest quarter of the year from a net sales perspective. The key takeaway is not to expect an unwinding due to changes in favorability quarter-on-quarter.

And the anticipated reduction for Medicaid volume? So, bottom line, Tammi, I think where we're at is we're not seeing the dramatic reduction in Medicaid that we thought we were at risk of. So, you know, I think we feel very good about the current trend we're on with regard to volume as well as net price.

And we expect more consistent sequential quarterly net sales growth continue to improve performance each quarter throughout the end of the year, with fourth quarter being our strongest performer.

Our next question comes from the line of Chase Knickerbocker with Craig-Hallum. So, bottom line, Tammi, I think where we're at is we're not seeing the dramatic reduction in Medicaid that we thought we were at risk of. So I think we feel very good about the current trend we're on with regard to volume as well as net price. Tammi Gaskins, Chief Commercial Officer, said we expect more consistent sequential quarterly net sales growth and to continue improving performance each quarter through the end of the year, with the fourth quarter being our strongest performer.

Maybe just on LINZESS net sales guidance. The high end of the range went up by a higher magnitude than the bottom. Just trying to understand the end caps on the guidance there. Is it a little bit of conservatism as far as IRA rebates in the back half affecting the bottom end of the range? Or could you help me understand both sides?

Hi, Chase. The increase in the guidance was actually consistent on each end of the range. It was up by $25 million. I think the major driver of the confidence to raise that guidance was the single-digit demand, which we've seen now, it's only 2 quarters in a row. So give us confidence we'll be able to land in that range. But just to reiterate, the range was improved consistently across both ends.

Understood. And then just as we think about, you know, the EBITDA guidance on the year. Any additional kind of color you can give us as far as kind of how we should be thinking about kind of R&D progressing in Q3 and Q4 on those step-ups just as we think about kind of the bottom end of the P&L.

Sure. Thanks, Chase. Appreciate the question. So for the remainder of '26, we do expect R&D expense to increase relative to the first half of the year. That reflects the ramp up of the STARS-2 trial we initiated in June. We also expect a modest increase in SG&A expense as well, I think through OpEx.

And obviously, Chase, that's all going to be depending on how many sites we can get up and running and how fast we can do that. And obviously, that's a critical investment in our future. So, you know, while obviously this quarter the EBITDA was remarkably strong, I think we certainly see that continuing throughout the end year, but we clearly will see an increased expense, as Ron mentioned, but that's going to be largely dependent on how many sites we can get up and running and how fast we can do it.

And there are no further questions at this time. With that, that concludes today's conference call. Thank you all for joining us. You may now disconnect, and have a good rest of your day.