IRWD

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:30 a.m. ET Chief Executive Officer - Thomas McCourt Chief Commercial Officer - Tammi Gaskins Chief Medical Officer and Head of Research and Drug Development - Jeffrey Silber Interim Chief Financial Officer - Ronald Silver Chief Strategy Officer - Jeff Ruberti VP, Investor Relations and Communications - Chris Stamm Operator: 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. [Operator Instructions] I would like to now turn the call over to Chris Stamm, VP, Investor Relations and Communications. Please go ahead. Chris Stamm: 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. Thomas McCourt: 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? Tammi Gaskins: 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. Jeffrey Silber: 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. Ronald Silver: 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. Thomas McCourt: 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. Operator: [Operator Instructions] Our first question comes from the line of Jason Butler from Fergusons. Jason Butler: 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? Tammi Gaskins: 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. Jason Butler: 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. Jeff Ruberti: 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? Jeffrey Silber: 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. Thomas McCourt: Yes, I think the big thing here, Jason, is really the expansion of the number of sites, particularly in the U.S. where we were with STARS. As you recall, there wasn't a lot of U.S. sites. It was largely ex-U.S. And we see a real opportunity here. And obviously that's building off real strong support from our steering committee -- scientific steering committee, who are a lot of the key investigators around the country, and also our ability to identify high-potential sites where there clearly is or we know there are patients that exist. And I think with our trial design and combining that with the clinical profile of the drug, we're pretty confident that we're going to be able to bring in a number of patients fairly quickly. But obviously, we'll be updating you and the rest of the investment community as we progress through that process. Operator: Our next question comes from the line of Mohit Bansal with Wells Fargo. Mohit Bansal: Great, thank you very much for taking my questions and congrats on all the progress. So I have 2 questions, one on apra and one on LINZESS. So there was some -- so for LINZESS, there was some concern around like -- could there be some plans they could have an issue given the price is higher now? Are you seeing anything like that in the Medicaid patient population? So far, it doesn't seem like that, but we'd love for you to touch upon that. And then for apra, so now that you are expanding to newer sites and all that, how do you make sure that trial conduct issues last time when people did not dose properly, how do you ensure that repeat of that doesn't happen as you go into more sites here? Jeff Ruberti: Tammi, do you want to take the first question on this? Tammi Gaskins: 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. Thomas McCourt: 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. And 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. Operator: [Operator Instructions] Our next question comes from the line of Dominic Rose with Intron Health. Dominic Rose: 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? Jeff Ruberti: Thanks, Dominic. Tammi, do you want to take both of those? Tammi Gaskins: Sure. I appreciate the question. This is Tammi. So, to start with the favorability of phasing of gross-to-net reserves, so first as I indicated in my comments, we do expect less variability in sequential quarterly net sales this year. We had quite a bit of variability last year because there was -- for 2 key reasons. One, there was more difference in net price across channels. And because of accruing rebates relative to actual demands dispensed in a quarter, that variability in price had more of a variability because of seasonality of certain sectors of the business. So this year, more consistent net price across channels, not be affected nearly to the extent of the seasonality and actual units dispensed, but also we expect to see quarter-on-quarter increase in performance with Q4 actually being the strongest quarter that we'll have this year from a net sales perspective. So in key takeaway, don't expect there to be an unwinding, if you will, due to changes in favorability quarter-on-quarter. Thomas McCourt: And the anticipated reduction for Medicaid volume? Tammi Gaskins: Yes. So, as I said, we saw strong 5% demand growth through mid-year. We've worked very hard at a state level with our payer to help maintain access across channels, including Medicaid, and we are still projecting to have our growth across channels to be in line with expectations to drive that mid-single-digit demand growth through the full year. Thomas McCourt: 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. Tammi Gaskins: 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. Operator: Our next question comes from the line of Chase Knickerbocker with Craig-Hallum. Chase Knickerbocker: 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 edge caps -- the end caps on the guidance there. Is it a little bit of conservatism just as far as kind of IRA rebates in the back half as far as the bottom end of the range? Or just maybe kind of help me understand both sides. Jeff Ruberti: 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. Chase Knickerbocker: 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. Jeff Ruberti: Absolutely. Ron, do you want to take that? Ronald Silver: 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. Thomas McCourt: 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. Operator: 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. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributed the strong Q2 performance to a second consecutive quarter of improved net price and mid-single-digit prescription demand growth for LINZESS. The elimination of inflationary rebates across channels has successfully stabilized net price, reducing the sequential quarterly variability seen in previous years. Strategic focus has shifted toward the rare disease pipeline with the initiation of the STARS-2 confirmatory Phase III trial for apraglutide in short bowel syndrome. The recent FDA approval of LINZESS for pediatric functional constipation (ages 2+) establishes it as the only prescription therapy in this category, expanding the brand's addressable market. Management emphasized a transition in leadership with the appointment of a new Chief Medical Officer and Interim CFO to oversee the next phase of clinical and commercial execution. Operational efficiency and strong cash flow enabled the repayment of $200 million in convertible notes, significantly strengthening the balance sheet. Full-year 2026 LINZESS net sales guidance was raised to $1.15 billion–$1.20 billion, assuming continued mid-single-digit demand growth and stable pricing dynamics. Management expects Q4 2026 to be the strongest quarter for net sales, following historical seasonal demand patterns where volume peaks in the second half of the year. The company aims to achieve a gross leverage ratio below 1x by year-end 2026 while maintaining sufficient liquidity for apraglutide's potential commercialization. R&D expenses are projected to increase in the second half of 2026 as the STARS-2 trial ramps up site activation and patient recruitment globally. Strategic efforts are focused on making apraglutide the first long-acting GLP-2 analog to reach the market, leveraging its once-weekly dosing profile. Management addressed previous dosing errors in the STARS trial by implementing a redesigned kit and improved instructions to ensure consistent delivery in the STARS-2 study. The company is monitoring potential demand softening in the Medicaid channel due to pricing changes, though current trends have remained more resilient than initially feared. The transition to an Interim CFO and a new CMO introduces a period of leadership evolution during a critical Phase III clinical execution phase. Future profitability remains dependent on the successful enrollment and execution of the STARS-2 trial, which is currently in the early stages of site activation. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management reported that demand has not softened as much as feared, with year-to-date volume growth at 5%, leading to an upgrade from 'low' to 'mid-single-digit' growth expectations. The company worked closely with partners to ensure ongoing patient access across channels despite the elimination of inflationary rebates. Ironwood is significantly expanding the number of U.S. clinical sites compared to the previous STARS trial, which was primarily conducted ex-U.S. The team is leveraging existing relationships from the largest SBS-IF trial conducted to date while identifying new high-potential sites to speed up recruitment. Management confirmed that the previous 3.5mg delivery error was caused by kit instructions; they have since conducted human factors studies and redesigned the kit to ensure 5mg delivery. They expressed high confidence that the dosing error will not recur in the STARS-2 trial, maintaining the integrity of the confirmatory data. Management does not expect an 'unwinding' of favorable reserves, noting that more consistent pricing across channels has reduced the volatility seen in 2025. Performance is expected to build sequentially, with the highest net sales projected for the fourth quarter.

This article first appeared on GuruFocus. Total Revenue: $113 million in Q2 2026. LINZESS U.S. Net Sales: $282.3 million in Q2 2026, a 14% year-over-year increase; first-half 2026 sales reached $555 million, up 44% year-over-year. LINZESS Prescription Demand: Mid-single-digit growth, with year-on-year EQ TRx volume growth of 4% in Q2 and 5% year-to-date through June. GAAP Net Income: $51.3 million in Q2 2026. Adjusted EBITDA: $83 million in Q2 2026. Cash and Cash Equivalents: $79 million at the end of Q2 2026. Collaboration Receivables: $113 million at the end of Q2 2026. Debt Repayment: Repaid $200 million convertible notes at maturity in June 2026. Full-Year 2026 Guidance (Raised): LINZESS U.S. net sales of $1.15 billion to $1.2 billion (greater than 30% year-over-year increase); total revenue of $460 million to $485 million; adjusted EBITDA greater than $310 million. Warning! GuruFocus has detected 7 Warning Signs with IRWD. Is IRWD fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. LINZESS delivered strong Q2 2026 performance with U.S. net sales of $282.3 million, a 14% year-over-year increase, driven by both demand growth and improved net price. The company raised its full-year 2026 guidance for LINZESS U.S. net sales to between $1.15 billion and $1.2 billion, representing a greater than 30% year-over-year increase and the highest annual sales in the product's history. FDA approval of LINZESS for functional constipation in pediatric patients two years of age and older expands the product's reach to a new patient population, addressing an unmet need. Apraglutide's Phase III STARS trial demonstrated significant reductions in parenteral support requirements, with more than one in five patients achieving enteral autonomy in the long-term extension study, positioning it as a potential best-in-class therapy. The company generated strong financial results with $51.3 million in GAAP net income and $83 million in adjusted EBITDA, and repaid its $200 million convertible notes at maturity, strengthening its balance sheet. The company expects to end 2026 with gross leverage below 1X, further enhancing financial flexibility to support apraglutide's development and commercialization. The company noted potential demand softening in Medicaid due to the elimination of inflationary rebates, although it has worked to mitigate this risk and currently expects mid-single-digit demand growth. The STARS II trial is still in early stages, with enrollment just beginning, and there is uncertainty regarding the timeline for completing the trial and potential delays in site activation. The company acknowledged a previous dosing error in the STARS trial (delivering 3.5 mg instead of 5 mg), which required root cause analysis and kit improvements, and there is a risk of similar issues in STARS II. R&D expenses are expected to increase in the second half of 2026 due to the ramp-up of STARS II, which could impact profitability despite strong current results. The company faces potential variability in gross-to-net rebate reserves, although it expects more consistent net pricing across channels this year. The company's guidance relies on continued mid-single-digit demand growth, which may be affected by seasonal factors and payer dynamics, posing a risk to achieving the higher end of the range. Q: Can you walk us through the dynamics around the potential impact on demand from the net price change, and what gives you increased comfort that there won't be a delayed negative impact?A: Tammi Gaskins, Chief Commercial Officer, stated that year-to-date through June, LINZESS prescription demand growth is tracking at 5%, which is modestly ahead of the low single-digit growth expected earlier in the year. Given that demand historically increases in the second half of the year, the company has raised its full-year demand expectation to mid-single-digits. She noted that they have worked extensively with their partner to ensure ongoing patient access across all channels, mitigating the anticipated demand softening from the elimination of inflationary rebates. Q: Regarding the STARS II trial, how is site onboarding going, and what strategies are you considering to potentially improve enrollment timelines?A: Jeff Ruberti, Chief Strategy Officer, noted it is early days since the trial initiated in June, but the first sites are activated and enrolling patients. Jeff Silver, Chief Medical Officer, added that the team is executing diligently on the established plan and is looking for opportunities to accelerate. CEO Thomas McCourt highlighted a key strategy: expanding the number of sites, particularly in the U.S., where the original STARS trial had limited presence. They are leveraging the scientific steering committee and identifying high-potential sites to bring patients in quickly. Q: Given the higher net price, are you seeing any issues with patient access in the Medicaid population, and how are you ensuring that the dosing errors from the STARS trial are not repeated in STARS II?A: Tammi Gaskins confirmed that despite initial concerns, they are not seeing the dramatic reduction in Medicaid volume that was anticipated. They have worked with states individually to maintain access. Regarding the dosing error, CEO Thomas McCourt explained that the original trial intended to deliver a 5mg dose but delivered 3.5mg due to kit instructions. Since then, they have dramatically improved the kit based on root cause analysis, conducted human factor studies, and gathered drug exposure data, giving them high confidence that the error will not be repeated in STARS II. Q: Both Q1 and Q2 saw favorable time phasing of gross-to-net rebate reserves. Should we expect this to unwind in H2, and is the reduced Medicaid volume growth expectation still in place?A: Tammi Gaskins explained that they expect less variability in sequential quarterly net sales this year due to more consistent net price across channels. She does not expect an unwinding of the favorability. The company expects quarterly performance to build, with Q4 being the strongest quarter. Regarding Medicaid, they are still projecting growth across all channels to be in line with expectations to drive mid-single-digit demand growth for the full year, as they have not seen the dramatic reduction they initially feared. Q: Can you provide more color on the LINZESS net sales guidance increase, and how should we think about R&D and SG&A expenses progressing in Q3 and Q4?A: Jeff Ruberti clarified that the guidance increase was consistent across both ends of the range, raised by $25 million, driven by confidence in the mid-single-digit demand growth. Interim CFO Ron Silver stated that R&D expense is expected to increase in the second half of the year due to the ramp-up of the STARS II trial, with a modest increase in SG&A as well. CEO Thomas McCourt added that the expense increase will depend on how quickly they can activate sites, which is a critical investment in the company's future. Q: What is driving the strong LINZESS performance, and what is the outlook for the rest of the year?A: Tammi Gaskins reported Q2 U.S. net sales of $282.3 million, a 14% year-over-year increase, driven by both demand growth and improved net price. Year-to-date sales reached $555 million, up 44%. The company raised its full-year guidance to between $1.15 billion and $1.2 billion, representing over 30% growth. This is fueled by improved net price and mid-single-digit prescription demand growth, with Q4 projected to be the highest net sales quarter for 2026. Q: Can you provide an update on the apraglutide clinical program and its potential?A: Jeff Silver, Chief Medical Officer, highlighted that apraglutide is the only once-weekly GLP-2 analog with positive Phase III data in SBS-IF. The STARS trial showed significant reductions in parenteral support requirements, with more than double the reduction in weekly volume compared to placebo at week 24. Long-term data from STARS-XTEND showed further reductions, with more than one in five patients achieving enteral autonomy. The drug's favorable tolerability and convenient dosing position it as a potential best-in-class therapy. Q: What were the key financial highlights for the second quarter, and what is the updated financial guidance?A: Interim CFO Ron Silver reported Q2 total revenue of $113 million, GAAP net income of $51 million, and adjusted EBITDA of $83 million. The company repaid its $200 million convertible notes at maturity with cash on hand. Full-year 2026 guidance was increased to LINZESS U.S. net sales of $1.15-$1.2 billion, total revenue of $460-$485 million, and adjusted EBITDA of greater than $310 million. The company expects to end the year with less than $300 million in gross debt. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Ironwood Pharmaceuticals, Inc.? Here are five stocks we like better. LINZESS sales strengthened: U.S. second-quarter sales rose 14% to $282.3 million, prompting Ironwood to raise 2026 LINZESS guidance to $1.15 billion-$1.2 billion. Apraglutide advanced: The company began enrolling patients in the confirmatory Phase III STARS-2 trial for short bowel syndrome with intestinal failure and is working to accelerate recruitment. Financial outlook improved: Ironwood repaid $200 million in convertible notes, raised 2026 revenue guidance to $460 million-$485 million and expects adjusted EBITDA above $310 million. 3 Stocks Trading Near $5 With Massive Earnings Upside Ironwood Pharmaceuticals (NASDAQ:IRWD) reported second-quarter results marked by higher LINZESS sales, the start of enrollment in its confirmatory Phase III study of apraglutide, and repayment of its convertible notes, prompting the company to raise its full-year 2026 financial outlook. Chief Executive Officer Thomas McCourt said the company remains focused on three priorities for 2026: maximizing LINZESS performance, advancing apraglutide for short bowel syndrome with intestinal failure, and delivering sustained profitability and cash flow. → 3 Drone Stocks That Should Soar After the Summer Slump Ironwood Pharmaceuticals’ 2026 Guidance Shock Sparks a Major Re-Rating LINZESS generated $282.3 million in U.S. net sales during the second quarter, up 14% from a year earlier. McCourt said performance was driven by improved net price and mid-single-digit prescription-demand growth. First-half U.S. net sales for LINZESS totaled $555 million, a 44% year-over-year increase. Chief Commercial Officer Tammi Gaskins said prescription volume, measured by total prescriptions, increased 4% in the second quarter and 5% through June. The company now expects mid-single-digit demand growth for the full year. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Gaskins attributed part of the higher net price to the continued benefit of eliminating inflationary rebates across channels, as well as favorable timing related to gross-to-net rebate reserves compared with the second quarter of 2025. She said Ironwood expects reduced quarterly variability in net sales during 2026 because net prices are more consistent across channels than they were last year. The company expects LINZESS demand to build in the second half, with the fourth quarter projected to produce the highest net sales of the year. Management said it does not expect a significant reduction in Medicaid demand after having worked with its partner and state payers to maintain patient access. → Jersey Mike's Serves Fresh Gains After IPO Stumble Ironwood raised its 2026 LINZESS U.S. net-sales guidance to between $1.15 billion and $1.2 billion, representing growth of more than 30% year over year. McCourt said the outlook would return LINZESS to blockbuster status and result in the highest annual U.S. net sales in the product’s history. During the quarter, the Food and Drug Administration approved LINZESS for functional constipation in pediatric patients ages 2 and older. McCourt said LINZESS is now the only prescription therapy approved for functional constipation in that age group. Ironwood initiated its confirmatory Phase III STARS-2 trial of apraglutide in June and has begun recruiting patients. The study is evaluating the once-weekly GLP-2 analog in adults with short bowel syndrome with intestinal failure who depend on parenteral support, such as IV fluids and nutrients. New Chief Medical Officer and Head of Research and Drug Development Jeff Silber said STARS-2 is a 24-week global, randomized, double-blind, placebo-controlled trial. Its primary endpoint is the relative change from baseline in actual weekly parenteral-support volume at week 24. Silber said the company is adding sites and leveraging infrastructure developed during the prior Phase III STARS trial, which included 68 global sites. Ironwood is also adding more U.S. sites and identifying high-potential locations with known patient populations in an effort to support enrollment. The company is evaluating opportunities to accelerate enrollment, though management characterized the process as being in its early stages. Chief Strategy Officer Jeff Ruberti said the company had activated its first sites and was enrolling patients. Silber highlighted prior STARS data showing apraglutide reduced parenteral-support requirements compared with placebo at week 24, with treatment effects observed as early as week eight. He said the study showed apraglutide was well tolerated, with overall safety and gastrointestinal tolerability similar to placebo. In the STARS long-term extension study, more than one in five enrolled patients had achieved enteral autonomy as of January 2025, according to Silber. He said Ironwood believes apraglutide’s once-weekly dosing, tolerability profile and clinical results could position it as a preferred GLP-2 treatment option if approved. Management also addressed a dosing issue from the original STARS trial. Silber said the intended 5-milligram dose resulted in delivery of 3.5 milligrams because of the study kit and instructions. He said Ironwood has redesigned the kit, completed human-factor studies and collected drug-exposure and pharmacokinetic data, adding that the company is confident it can control dosing in STARS-2. Ironwood reported second-quarter total revenue of $113 million, GAAP net income of $51.3 million and adjusted EBITDA of $83 million. The company ended the quarter with $79 million in cash and cash equivalents, along with $113 million in collaboration receivables. Interim Chief Financial Officer Ron Silver said Ironwood repaid its $200 million convertible notes at maturity in June using cash on hand. The company plans to use operating cash flow to further reduce debt and expects to end 2026 with less than $300 million in gross debt outstanding. McCourt said the company expects gross leverage to be below one times by year-end. For 2026, Ironwood raised total revenue guidance to between $460 million and $485 million and now expects adjusted EBITDA of more than $310 million. Silver said research and development expense should rise in the second half as the STARS-2 study ramps up, while selling, general and administrative expenses are expected to increase modestly. McCourt also announced leadership changes, including Silber’s appointment as chief medical officer following the retirement of former CMO and R&D head Mike Schutzelein. Ron Silver, previously senior vice president, corporate controller and chief accounting officer, is serving as interim CFO. Ironwood Pharmaceuticals, Inc is a commercial‐stage biotechnology company focused on the discovery, development and commercialization of medicines for gastrointestinal (GI) disorders. The company's flagship product is linaclotide, marketed under the brand name LINZESS in the United States for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). Through a strategic collaboration with Allergan (now part of AbbVie), Ironwood also commercializes linaclotide in select ex-U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Ironwood Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

– Raises full-year 2026 LINZESS® (linaclotide) U.S. net sales guidance to $1.15 - $1.20 billion, representing greater than 30% increase year-over-year; Raises total revenue guidance to $460 - $485 million and adjusted EBITDA guidance to greater than $310 million – – Q2 2026 LINZESS U.S. net sales of $282 million; $555 million year-to-date representing 44% year-over-year growth – – Total revenue of $113 million, GAAP net income of $51 million and adjusted EBITDA of $83 million in Q2 2026; repaid $200 million convertible notes with cash on hand – – Confirmatory Phase 3 STARS-2 trial of apraglutide in short bowel syndrome with intestinal failure (SBS-IF) now actively recruiting patients – BOSTON, August 06, 2026--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life‑changing therapies for people living with gastrointestinal (GI) and rare diseases, today reported its second quarter 2026 results and recent business performance. "Throughout the first half of the year, we have remained laser focused on meaningful execution of our three strategic priorities: maximizing LINZESS, advancing apraglutide, and delivering sustained profits and cash flows," said Tom McCourt, chief executive officer of Ironwood. "We are pleased to report a second consecutive quarter of strong performance for LINZESS, fueled by improved net price and mid-single digit prescription demand growth which supported our decision to raise our full-year 2026 financial guidance. We also repaid our $200 million convertible notes during the quarter using cash on hand and remain committed to further debt reduction and strengthening our balance sheet through year end." "Importantly, we initiated STARS-2 and are actively recruiting patients in this confirmatory Phase 3 trial of apraglutide with the goal that it will be the first long-acting GLP-2 analog to market. Based on the positive Phase 3 STARS data and the confirmatory design of STARS-2, we are confident that apraglutide has the potential to be a best-in-class therapy for people with short bowel syndrome with intestinal failure, a condition with significant unmet need," McCourt continued. "With Dr. Jeffrey Silber now serving as chief medical officer and head of research and drug development, his proven clinical development leadership further strengthens our ability to advance apraglutide and bring it to patients as quickly as possible." Second Quarter 2026 Financial Highlights1 Second Quarter Corporate Highlights U.S. LINZESS In May 2026, the U.S. Food and Drug Administration (FDA) approved the use of LINZESS in pediatric patients 2 years of age and older with functional constipation (FC). LINZESS remains the only FDA-approved prescription therapy for pediatric FC. Prescription Demand: Total LINZESS demand in the second quarter of 2026 was 59.8 million LINZESS capsules, a 4% increase compared to the second quarter of 2025, per IQVIA. Based on this performance, we raised our U.S. LINZESS net sales guidance, which now reflects a mid-single digit percentage demand growth. U.S. Brand Collaboration: LINZESS U.S. net sales are provided to Ironwood by its U.S. partner, AbbVie Inc. ("AbbVie"). LINZESS U.S. net sales were $282.3 million in the second quarter of 2026, a 14% increase compared to $248.0 million in the second quarter of 2025. Ironwood and AbbVie share equally in U.S. brand collaboration profits. Collaboration Revenue to Ironwood: Ironwood recorded $110.0 million in collaboration revenue in the second quarter of 2026 related to sales of LINZESS in the U.S., a 28% increase compared to $85.7 million for the second quarter of 2025. See the U.S. LINZESS Commercial Collaboration table at the end of the press release. Apraglutide Ironwood initiated and is actively recruiting patients for STARS-2, (NCT07742735) a confirmatory Phase 3 clinical trial of apraglutide for patients with SBS-IF dependent on parenteral support ("PS"), a severe chronic malabsorptive condition. STARS-2 is a 24-week global, randomized, double-blind, placebo-controlled trial. The primary endpoint is relative change from baseline in actual weekly PS volume. Secondary endpoints also to be measured at week 24 for the overall population include clinical response (defined as a 20% reduction in PS volume), number of days of PS per week, and enteral autonomy. Apraglutide is a once-weekly, long-acting synthetic glucagon-like peptide-2 ("GLP-2") analog with the potential to treat a range of rare GI diseases in which GLP-2 can play a central role in addressing disease pathophysiology. Based on positive data generated from the STARS Phase 3 trial, Ironwood believes apraglutide has the potential to be a best-in-class therapeutic to improve the standard of care for adult patients with SBS who are dependent on PS, as the first and only GLP-2 to achieve a statistically significant reduction in weekly PS volume with once-weekly administration. In May 2026, during the 2026 Digestive Disease Week (DDW) conference, Ironwood presented data pooled from studies in the STARS clinical program - including the Phase 2 STARS Nutrition study, STARS Phase 3 randomized placebo-controlled study, and the ongoing open-label extension study STARS Extend. In this analysis, apraglutide showed a safety profile consistent with previous studies. These findings build on the positive data previously announced in 2024. Corporate Updates In May, Ronald Silver, Ironwood’s Corporate Controller and Chief Accounting Officer, was appointed as Interim Chief Financial Officer, following the resignation of Gregory Martini. In July, Dr. Jeffrey Silber joined Ironwood as Chief Medical Officer and Head of Research and Drug Development, following the retirement of Dr. Michael Shetzline. With broad medical and scientific leadership expertise, Dr. Silber will lead Ironwood’s next phase of R&D strategy and execution. Second Quarter 2026 Financial Results Total Revenue. Total revenue in the second quarter of 2026 was $113.0 million, compared to $85.2 million in the second quarter of 2025. Total Costs and Expenses. Total costs and expenses in the second quarter of 2026 were $33.7 million, compared to $39.9 million in the second quarter of 2025. Interest Expense. Interest expense was $7.2 million in the second quarter of 2026, in connection with Ironwood’s convertible senior notes, which were paid at maturity in June 2026, and revolving credit facility. Interest expense was $8.4 million in the second quarter of 2025 in connection with Ironwood’s convertible senior notes and revolving credit facility. Interest and Investment Income. Interest and investment income was $1.6 million in the second quarter of 2026 and $0.8 million in the second quarter of 2025. Other. Other income was insignificant in the second quarter of 2026 and in the second quarter of 2025 and pertained to a gain recorded for pension-related activities. Income Tax Expense. Ironwood recorded $22.4 million of income tax expense in the second quarter of 2026, the majority of which was non-cash, as Ironwood continues to utilize net operating losses to offset taxable income for federal purposes and in many states. Ironwood recorded $14.2 million of income tax expense in the second quarter of 2025, the majority of which was non-cash, as Ironwood continued to utilize net operating losses to offset taxable income for federal purposes and in many states. GAAP Net Income. GAAP net income was $51.3 million, or $0.31 per share (basic and diluted) in the second quarter of 2026, compared to GAAP net income of $23.6 million, or $0.15 per share (basic) and $0.14 per share (diluted) in the second quarter of 2025. Non-GAAP Net Income. Non-GAAP net income was $51.5 million, or $0.31 per share (basic and diluted), in the second quarter of 2026, compared to non-GAAP net income of $23.6 million, or $0.15 per share (basic) and $0.14 per share (diluted), in the second quarter of 2025. Adjusted EBITDA. Adjusted EBITDA was $83.0 million in the second quarter of 2026, compared to $50.1 million in the second quarter of 2025. Cash Flow Highlights. Ironwood ended the second quarter of 2026 with $79.1 million of cash and cash equivalents, compared to $215.5 million of cash and cash equivalents at the end of 2025. Ironwood 2026 Financial Guidance. Ironwood is raising its 2026 financial guidance and now expects: Non-GAAP Financial Measures Ironwood presents non-GAAP net income (loss) and non-GAAP net income (loss) per share to exclude amortization of acquired intangible assets, and net restructuring expenses, all net of tax effect. Non-GAAP adjustments are further detailed below: Amortization of acquired intangible assets are non-cash expenses arising in connection with the acquisition of VectivBio, which is considered to be non-recurring. Restructuring expenses are considered to be a non-recurring event as they are associated with distinct operational decisions. Restructuring expenses include costs associated with exit and disposal activities. Ironwood also presents adjusted EBITDA, a non-GAAP measure, as well as guidance on adjusted EBITDA. Adjusted EBITDA is calculated by subtracting stock-based compensation, net restructuring expenses, net interest expense, income taxes, depreciation and amortization from GAAP net income (loss). The adjustments are made on a similar basis as described above related to non-GAAP net income (loss), as applicable. Management believes this non-GAAP information is useful for investors, taken in conjunction with Ironwood’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood’s operating performance. These measures are also used by management to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of non-GAAP net income (loss) and non-GAAP net income (loss) per share to GAAP net income (loss) and GAAP net income (loss) per share, respectively, and for a reconciliation of adjusted EBITDA to GAAP net income (loss), please refer to the tables at the end of this press release. Ironwood does not provide guidance on GAAP net income or a reconciliation of expected adjusted EBITDA to expected GAAP net income because, without unreasonable efforts, it is unable to predict with reasonable certainty the non-GAAP adjustments used to calculate adjusted EBITDA. These adjustments are uncertain, depend on various factors and could have a material impact on GAAP net income for the guidance period. Conference Call Information Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time on Thursday, August 6th, 2026, to discuss its second quarter results and recent business activities. Individuals interested in participating in the call should dial (888) 596-4144 (U.S.) or (646) 968-2525 (international) using conference ID number and event passcode 3647053. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com. The call will be available for replay via telephone starting Thursday, August 6, 2026, at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on Thursday, August 20, 2026. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) using conference ID number 3647053. The archived webcast will be available on Ironwood’s website for one year beginning approximately one hour after the call has completed. About Ironwood Pharmaceuticals Ironwood Pharmaceuticals (Nasdaq: IRWD) is a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases. Ironwood is advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for short bowel syndrome patients who are dependent on parenteral support. In addition, Ironwood has been a pioneer in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for the treatment of irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Building upon our history of innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of diseases and address significant unmet needs. Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland. We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on X and on LinkedIn. About LINZESS (Linaclotide) LINZESS® is the #1 prescribed brand in the U.S. for the treatment of patients with irritable bowel syndrome with constipation ("IBS-C") or chronic idiopathic constipation ("CIC"), based on IQVIA data. LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C in adults and pediatric patients 7 years of age and older. LINZESS has also been shown to relieve constipation, infrequent stools, hard stools, straining and incomplete evacuation associated with CIC in adult patients. LINZESS relieves constipation in children and adolescents aged 2 to 17 years with functional constipation. LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of IBS-C in adults and pediatric patients 7 years of age and older, CIC in adults and functional constipation (FC) in pediatric patients 2 years of age and older. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with Grand Life Sciences for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide. LINZESS Important Safety Information INDICATIONS AND USAGE LINZESS® (linaclotide) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older, chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients 2 years of age and older. IMPORTANT SAFETY INFORMATION Contraindications LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration. LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Warnings and Precautions Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism, which was associated with increased mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. Diarrhea In adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of adult patients with IBS-C or CIC treated with LINZESS 145 mcg or 290 mcg once daily, and in <1% of adult patients with CIC treated with LINZESS 72 mcg once daily. In pediatric patients, diarrhea was also the most common adverse reaction in clinical trials of patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC treated with LINZESS. In two double-blind trials, diarrhea was reported in 4% of pediatric patients 6 to 17 years of age with FC treated with LINZESS 72 mcg once daily, and 7% and 8% of pediatric patients 7 to 17 years of age with IBS-C treated with LINZESS 145 mcg and 290 mcg once daily, respectively. In clinical trials, severe diarrhea was reported in one pediatric patient with FC treated with LINZESS 72 mcg once daily and in one pediatric patient with IBS-C treated with LINZESS at a dose higher than the recommended 145 mcg once daily dosage for IBS-C. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated. Common Adverse Reactions (incidence ≥2% and greater than placebo) In adult patients with IBS-C or CIC: diarrhea, abdominal pain, flatulence and abdominal distension. In pediatric patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC: diarrhea. Please see full Prescribing Information including Boxed Warning:https://www.rxabbvie.com/pdf/linzess_pi.pdf LINZESS® and CONSTELLA® are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Ironwood’s ability to execute on its mission; Ironwood’s strategy, business, financial position and operations; Ironwood’s ability to drive growth and profitability; the commercial potential of LINZESS; Ironwood’s financial performance and results, and guidance and expectations related thereto; LINZESS prescription demand growth, LINZESS U.S. net sales, total revenue and adjusted EBITDA in 2026; our commitment to further debt reduction and strengthening our balance sheet and the timing to achieve thereof; anticipated recruitment in our STARS-2 trial; the goal of bringing the first long-acting, once-weekly GLP-2 analog to market; and our belief that apraglutide has the potential to become a best-in-class, long-acting GLP-2 therapy for people with SBS-IF. These forward-looking statements speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development of linaclotide, apraglutide, and our other product candidates; the risk of uncertainty relating to pricing and reimbursement policies in the U.S., which, if not favorable for our products, could hinder or prevent our products’ commercial success; the risk that clinical programs and studies, including for apraglutide, may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risk that findings from our completed nonclinical studies and clinical trials may not be replicated in later trials and earlier-stage clinical trials may not be predictive of the results we may obtain in later-stage clinical trials or of the likelihood of regulatory approval; the risk that apraglutide will not be approved by the FDA or other regulatory agencies; the risk of competition or that new products may emerge that provide different or better alternatives for treatment of the conditions that our products are approved to treat; the risk that healthcare reform and other governmental and private payor initiatives may have an adverse effect upon or prevent our products’ or product candidates’ commercial success; the efficacy, safety and tolerability of linaclotide and our product candidates; the risk that the commercial and therapeutic opportunities for LINZESS, apraglutide or our other product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional patent protection for linaclotide, apraglutide and other product candidates, that patents for linaclotide, apraglutide or other products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; the risk that the development of apraglutide is not successful or that any of our product candidates does not receive regulatory approval or is not successfully commercialized; outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including abbreviated new drug application litigation; the risk that financial and operating results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues; developments in accounting guidance or practice; Ironwood’s or AbbVie’s accounting practices, including reporting and settlement practices as between Ironwood and AbbVie; the risk that our indebtedness could adversely affect our financial condition or restrict our future operations; and the risks listed under the heading "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2025, and in our subsequent Securities and Exchange Commission filings. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806795754/en/ Contacts Investors and Media: Chris StammVice President, Investor Relations and [email protected] Investors: Precision AQStephanie [email protected]

Ironwood Pharmaceuticals (IRWD) came out with quarterly earnings of $0.31 per share, beating the Zacks Consensus Estimate of $0.26 per share. This compares to earnings of $0.14 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +19.23%. A quarter ago, it was expected that this drugmaker would post earnings of $0.07 per share when it actually produced earnings of $0.24, delivering a surprise of +242.86%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Ironwood, which belongs to the Zacks Medical - Drugs industry, posted revenues of $113.04 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 5.66%. This compares to year-ago revenues of $85.24 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Ironwood shares have added about 23.2% since the beginning of the year versus the S&P 500's gain of 12.8%. While Ironwood has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Ironwood was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.30 on $149.24 million in revenues for the coming quarter and $1.04 on $473.42 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Harrow (HROW), has yet to report results for the quarter ended June 2026. The results are expected to be released on August 10. This pharmaceutical and drug compounding company is expected to post quarterly loss of $0.23 per share in its upcoming report, which represents a year-over-year change of -195.8%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Harrow's revenues are expected to be $71.1 million, up 11.5% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ironwood Pharmaceuticals, Inc. (IRWD) : Free Stock Analysis Report Harrow, Inc. (HROW) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

We recently compiled a list of the 8 Best Small Cap Pharma Stocks to Buy Right Now. Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) is among the best small cap pharma stocks. TheFly reported on May 7 that IRWD reported its first-quarter 2026 financial performance for the period ended March 31, 2026, showing great year-over-year improvement. Total revenue increased to $106.5 million from $41.1 million, driven primarily by a higher share of U.S. net profits from LINZESS. Total expenses declined significantly to $33.9 million from $70.3 million, reflecting lower R&D, SG&A, and restructuring costs. The company reported that GAAP net income reached $40.8 million compared with a loss of $37.4 million a year earlier, while non-GAAP net income also turned positive at $40.9 million. Adjusted EBITDA improved sharply to $76.7 million versus a loss of $4.7 million. Cash and cash equivalents rose to $220.5 million, with continued operating cash generation and improved profitability across core segments. Beyond financials, on May 4, Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) also shared new data from a healthcare provider survey presented at Digestive Disease Week 2026 focused on treatment approaches in short bowel syndrome and the use of total parenteral nutrition. Providers highlighted the clinical goal of reducing reliance on TPN to improve patient quality of life and limit complications such as infections, thrombosis, fatigue, and line-related pain. Most respondents prioritized lowering the number of days patients require TPN each week, while others focused on reducing daily infusion time, with fewer emphasizing volume reduction. The findings underscored the significant long-term burden of TPN dependence, particularly complications linked to central venous access, which were identified as among the most distressing for patients and key limitations in current treatment approaches for short bowel syndrome. Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) is a biopharmaceutical company focused on developing and commercializing transformative therapies for gastrointestinal (GI) and rare diseases. While we acknowledge the potential of IRWD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.

Interested in Ironwood Pharmaceuticals, Inc.? Here are five stocks we like better. LINZESS momentum: Q1 U.S. net sales were $272.5 million, up 97% year-over-year driven by net price improvements (including elimination of inflationary rebates) and ~5% prescription growth, and management reiterated 2026 LINZESS guidance of $1.125–1.175 billion in U.S. net sales with company-level adjusted EBITDA > $300 million. Apraglutide progress and opportunity: The confirmatory STARS-2 phase III is on track for site initiation in Q2 with 124 patients randomized and a primary endpoint of relative parenteral support volume change at week 24, as Ironwood targets a roughly 18,000 global SBS-IF patient pool and a U.S. TAM of > $4 billion. Financial strength and debt plans: Ironwood reported Q1 GAAP net income of $40.8 million and adjusted EBITDA of $76.7 million, held $220.5 million in cash, and plans to repay its 2026 convertible note in cash while targeting year-end total debt of ~ $300 million (under 1x expected 2026 adjusted EBITDA). 3 Stocks Trading Near $5 With Massive Earnings Upside Ironwood Pharmaceuticals (NASDAQ:IRWD) reported a strong start to 2026 and reiterated its full-year outlook, pointing to sharp first-quarter growth for LINZESS and continued progress toward a confirmatory phase III program for apraglutide in short bowel syndrome with intestinal failure (SBS-IF). Chief Executive Officer Thomas McCourt said the company’s 2026 priorities are “maximizing LINZESS, advancing apraglutide, and delivering sustained profits and cash flow,” adding that the first quarter included progress across each area. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Ironwood Pharmaceuticals’ 2026 Guidance Shock Sparks a Major Re-Rating McCourt said LINZESS remained the prescription leader in irritable bowel syndrome with constipation and chronic idiopathic constipation and posted “97% year-over-year net sales growth” in the first quarter, driven primarily by improved net price and supported by 5% prescription demand growth. Chief Commercial Officer Tammi Gaskins reported LINZESS first-quarter U.S. net sales of $272.5 million, a 97% increase versus the first quarter of 2025. She attributed the net price improvement primarily to two factors: Elimination of inflationary rebates across channels, including Medicaid, which Gaskins said is expected to persist through 2026 and is reflected in guidance. Favorable time phasing of gross-to-net rebate reserves compared with the prior-year quarter. → Years in the Making, AMD’s Upside Movement Has Just Begun Gaskins also said the company expects “reduced variability in sequential quarterly LINZESS U.S. net sales” in 2026 compared with 2025 due to more consistent net price across channels. In the quarter, Ironwood also recognized $104.2 million in U.S. brand collaboration revenue, up 169% from $38.8 million in the year-ago period. During the Q&A, CFO Greg Martini said the first-quarter demand growth rate was “slightly above” the company’s low-single-digit full-year expectation but “in line with our expectations” within the guidance framework. He added that the company does not expect the same quarterly fluctuations seen in 2025, forecasting more consistent phasing through 2026. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Asked about what could pressure demand later in the year, Martini said Ironwood had anticipated some response to pricing changes and specifically noted Medicaid as an area where it could see reduced growth in the back half of 2026. McCourt highlighted ongoing efforts to broaden LINZESS use into younger populations. He said the FDA accepted a supplemental new drug application for LINZESS to treat functional constipation in children ages two to five, granted priority review, and set a PDUFA target action date of May 24, 2026. McCourt noted LINZESS is currently the only FDA-approved drug for children seven years and older with IBS-C and for children six to 17 with functional constipation. In response to an analyst question about the commercial magnitude of a two-to-five-year-old label expansion, Gaskins said the company is “very excited” about potentially offering a prescription therapy to an additional pediatric population and expects it would support incremental demand, but emphasized the adult IBS-C and CIC populations remain “the main driver of growth over the next few years.” Ironwood also outlined progress for apraglutide in SBS-IF. McCourt said the company advanced the STARS-2 confirmatory phase III trial in the quarter by completing clinical site feasibility and remains on track for site initiation in the second quarter. At Digestive Disease Week (DDW) in Chicago, the company presented results from the LANDMARK survey and updated long-term extension data. McCourt said the LANDMARK survey underscored the need for therapies addressing multiple dimensions of the burden of total parenteral nutrition (TPN), and that patients identified reduction in days of TPN as a top priority. He also said additional long-term extension data presented at DDW showed a safety profile consistent with prior studies. Chief Medical Officer Michael Shetzline provided details on STARS-2, describing it as designed based on FDA interactions to “confirm and further support” prior STARS phase III data. Key elements he cited include: 124 patients enrolled with SBS-IF in a 1:1 randomization Inclusion of both stoma and colon-in-continuity patient populations Primary endpoint: relative parenteral support volume change from baseline at week 24 Secondary endpoints at week 24: clinical response (defined as 20% reduction in parenteral support volume), days off parenteral support per week, and enteral autonomy Dose: 3.5 mg once weekly, intended to confirm the efficacy and tolerability seen previously On trial execution, Shetzline said the company is leveraging operational experience from the original STARS program and will continue to use prior sites while also evaluating additional centers to support recruitment. In response to a question about stratification, Shetzline said STARS-2 will not formally stratify colon-in-continuity and stoma patients, but the company will track recruitment to ensure a representative mix aligned with FDA discussions. Gaskins also summarized the company’s view of the commercial opportunity, estimating roughly 18,000 SBS-IF patients across the U.S., Europe, and Japan, including more than 8,000 patients in the U.S. dependent on parenteral support three or more days per week. She characterized that subgroup as representing a total addressable U.S. market of more than $4 billion. Based on public disclosures and claims data, she estimated about 1,500 to 2,000 patients are on GATTEX at any given time, which she said suggests “significant opportunity” to increase overall GLP-2 utilization. Gaskins also said the STARS phase III trial showed a twofold relative reduction in parenteral support volume at 24 weeks with once-weekly apraglutide versus placebo, and that in the STARS Extend long-term extension study, “approximately 1 in 5 or 20% of patients achieved enteral autonomy as of January 2025.” She added that pooled long-term safety data across the STARS program showed a safety and tolerability profile consistent with previous studies, low discontinuation rates due to treatment-emergent adverse events, and no new safety observations. Ironwood reported first-quarter GAAP net income of $40.8 million and adjusted EBITDA of $76.7 million. Martini said total revenue in the quarter was $106.5 million. The company ended the quarter with $220.5 million in cash and cash equivalents and $105.8 million in accounts receivable, which Martini said is expected to be collected before the June 15 maturity of the company’s convertible notes. Martini said Ironwood plans to use cash on hand and 2026 cash flows to reduce debt and intends to repay the 2026 convertible note in cash at maturity. He added the company expects to end the year with approximately $300 million of total debt, “less than 1x our expected 2026 adjusted EBITDA.” Management reiterated its 2026 guidance, including: LINZESS U.S. net sales: $1.125 billion to $1.175 billion Ironwood revenues: $450 million to $475 million Adjusted EBITDA: greater than $300 million On expenses, Martini said R&D is expected to ramp through the remainder of 2026 as STARS-2 initiates. He also noted that lower commercial reimbursements versus the year-ago quarter reflected a restructuring completed in the first quarter of 2025 and said the first quarter of 2026 is more representative of the run rate for the rest of 2026. Asked about lifecycle management for LINZESS and potential over-the-counter (OTC) plans, Shetzline said the company believes LINZESS has an OTC opportunity given its safety database and said Ironwood is in ongoing engagement with AbbVie on an OTC plan, adding the company will provide updates in the future. Ironwood Pharmaceuticals, Inc is a commercial‐stage biotechnology company focused on the discovery, development and commercialization of medicines for gastrointestinal (GI) disorders. The company's flagship product is linaclotide, marketed under the brand name LINZESS in the United States for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). Through a strategic collaboration with Allergan (now part of AbbVie), Ironwood also commercializes linaclotide in select ex-U.S. The article "Ironwood Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.