US Market News
2 months ago
Ironwood Pharmaceuticals Reports Strong First Quarter 2026 Results With 97% Year-Over-Year LINZESS U.S. Net Sales Growth; Maintains Full-Year 2026 Financial GuidanceMay 7, 2026 7:05 AM
Business Wire – LINZESS® (linaclotide) U.S. net sales of $273 million in Q1 2026, primarily driven by improved net price and 5% EUTRx demand growth year-over-year – – Total revenue of $107 million, GAAP net income of $41 million and adjusted EBITDA of $77 million in Q1 2026 – – On track to begin site initiations for Phase 3 confirmatory trial of apraglutide in short bowel syndrome with intestinal failure (SBS-IF) in the second quarter of 2026 – – sNDA for LINZESS treatment of functional constipation (FC) in patients 2 to 5 years of age accepted and granted priority review by FDA; PDUFA date set for May 24th – 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 first quarter 2026 results and recent business performance. “Our first quarter of 2026 delivered strong financial performance, driven by significantly improved net price and mid-single digit prescription growth for LINZESS, positioning us well to achieve our full-year 2026 financial guidance,” said Tom McCourt, chief executive officer of Ironwood. “We expect strong first quarter revenue to result in significant operating cash flows in the second quarter of 2026, which will help support repayment of our 2026 convertible notes at maturity in June.” “We remain on track for site initiation for the confirmatory STARS-2 Phase 3 clinical trial in the second quarter,” said Michael Shetzline, chief medical officer, senior vice president and head of research and drug development at Ironwood. “Building on the positive results from STARS, we believe that the highly potent, selective, and long-acting pharmacologic properties of apraglutide have the potential to drive best-in-class efficacy and tolerability with once-weekly dosing and redefine the standard of care in SBS-IF. Importantly, the long-term data generated to date show compelling enteral autonomy outcomes, with rapid and sustained reductions in parenteral support over time.” First Quarter 2026 Financial Highlights1 (in thousands, except for per share amounts) Q1 2026 Q1 2025 Total revenue $ 106,506 $ 41,143 Total costs and expenses 33,933 70,251 GAAP net income (loss) 40,773 (37,386 ) GAAP net income (loss) – per share basic 0.25 (0.23 ) GAAP net income (loss) – per share diluted 0.24 (0.23 ) Adjusted EBITDA2 76,671 (4,742 ) Non-GAAP net income (loss) 40,945 (23,228 ) Non-GAAP net income (loss) per share – basic 0.25 (0.14 ) Non-GAAP net income (loss) per share – diluted 0.24 (0.14 ) 1 Refer to the Reconciliation of GAAP Results to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA table at the end of this press release. Refer to Non-GAAP Financial Measures for additional information. 2 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). First Quarter and Full Year 2026 Corporate Highlights U.S. LINZESS In January 2026, the FDA accepted and granted priority review of a supplemental New Drug Application (sNDA) for LINZESS for the treatment of functional constipation (FC) in patients 2 to 5 years of age. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of May 24th. Prescription Demand: Total LINZESS prescription demand in the first quarter of 2026 was 56.0 million LINZESS capsules, a 5% increase compared to the first quarter of 2025, per IQVIA. 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 $272.5 million in the first quarter of 2026, a 97% increase compared to $138.5 million in the first quarter of 2025. Ironwood and AbbVie share equally in U.S. brand collaboration profits. Q1 2026 LINZESS U.S. net sales growth year-over-year was driven by 5% demand growth and significantly improved net price due to elimination of inflationary rebates and favorable time-phasing of gross-to-net rebate reserves in the first quarter of 2026 relative to 2025. LINZESS commercial margin was 76% in the first quarter of 2026, compared to 52% in the first quarter of 2025. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release. Net profit for the LINZESS U.S. brand collaboration, net of commercial and research and development (“R&D”) expenses, was $204.7 million in the first quarter of 2026, a 211% increase compared to $65.9 million in the first quarter of 2025. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release. Collaboration Revenue to Ironwood: Ironwood recorded $104.2 million in collaboration revenue in the first quarter of 2026 related to sales of LINZESS in the U.S., a 169% increase compared to $38.8 million for the first quarter of 2025. See the U.S. LINZESS Commercial Collaboration table at the end of the press release. Apraglutide Apraglutide is a once weekly, long-acting synthetic glucagon-like peptide-2 (“GLP-2”) analog with the potential to treat a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology. Ironwood is advancing apraglutide for short bowel syndrome (“SBS”) patients dependent on parenteral support (“PS”), a severe chronic malabsorptive condition. Ironwood believes apraglutide has the potential 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. Ironwood expects to begin initiating clinical sites in the second quarter of 2026, for STARS-2, a confirmatory Phase 3 clinical trial of apraglutide for patients with SBS-IF. STARS-2 is planned to be a 24-week global, randomized, double-blind, placebo-controlled trial. The primary endpoint is relative change from baseline in actual weekly PS volume, with additional key secondary endpoints also planned. In May, during the 2026 Digestive Disease Week (DDW), Ironwood presented data pooled from 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 - apraglutide showed a safety profile consistent with previous studies. These findings build on the positive data previously announced in 2024. First Quarter 2026 Financial Results Total Revenue. Total revenue in the first quarter of 2026 was $106.5 million, compared to $41.1 million in the first quarter of 2025. Total revenue in the first quarter of 2026 consisted of $104.2 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., and $2.3 million in royalties and other revenue. Total revenue in the first quarter of 2025 consisted of $38.8 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., and $2.3 million in royalties and other revenue. Total Costs and Expenses. Total costs and expenses in the first quarter of 2026 were $33.9 million, compared to $70.3 million in the first quarter of 2025. Total costs and expenses in the first quarter of 2026 consisted of $21.9 million in R&D expenses, $12.0 million in selling, general and administrative (“SG&A”) expenses, and reversal of an insignificant amount in restructuring expenses. Total costs and expenses in the first quarter of 2025 consisted of $27.4 million in R&D expenses, $24.3 million in SG&A expenses, and $18.6 million in restructuring expenses. Interest Expense. Interest expense was $9.1 million in the first quarter of 2026, in connection with Ironwood’s convertible senior notes and revolving credit facility. Interest expense was $8.1 million in the first quarter of 2025 in connection with Ironwood’s convertible senior notes and revolving credit facility. Interest and Investment Income. Interest and investment income was $1.7 million in the first quarter of 2026 and $0.9 million in the first quarter of 2025. Other. Other income was insignificant in the first quarter of 2026 and in the first quarter of 2025 and pertained to a gain recorded for pension-related activities. Income Tax Expense. Ironwood recorded $24.4 million of income tax expense in the first 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 $1.1 million of income tax expense in the first 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 (Loss). GAAP net income was $40.8 million, or $0.25 per share (basic) and $0.24 per share (diluted) in the first quarter of 2026, compared to GAAP net loss of $37.4 million, or ($0.23) per share (basic and diluted) in the first quarter of 2025. Non-GAAP Net Income (Loss). Non-GAAP net income was $40.9 million, or $0.25 per share (basic) and $0.24 per share (diluted), in the first quarter of 2026, compared to non-GAAP net loss of $23.2 million, or ($0.14) per share (basic and diluted), in the first quarter of 2025. Non-GAAP net income (loss) excludes the impact of amortization of acquired intangible assets, and net restructuring expenses, all net of tax effect. See Non-GAAP Financial Measures below. Adjusted EBITDA. Adjusted EBITDA was $76.7 million in the first quarter of 2026, compared to ($4.7) million in the first quarter of 2025. 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). See Non-GAAP Financial Measures below. Cash Flow Highlights. Ironwood ended the first quarter of 2026 with $220.5 million of cash and cash equivalents, compared to $215.5 million of cash and cash equivalents at the end of 2025. The outstanding principal balance on the revolving credit facility was $385.0 million as of March 31, 2026. Ironwood generated $5.1 million in cash from operations in the first quarter of 2026, compared to $20.0 million in cash from operations in the first quarter of 2025. Ironwood had $105.8 million in accounts receivable as of March 31, 2026, primarily related to first quarter 2026 collaboration revenues. Ironwood 2026 Financial Guidance. Ironwood continues to expect: 2026 Guidance (May 2026) U.S. LINZESS Net Sales $1.125 - $1.175 billion Driven by improved net price and low-single digit percentage demand growth Total Revenue1 $450 - $475 million Adjusted EBITDA2 >$300 million 1 Ironwood’s U.S. collaborative arrangements revenue includes reimbursement from AbbVie for a portion of Ironwood’s commercial expenses related to sales of LINZESS in the U.S. 2 Adjusted EBITDA is calculated by subtracting stock-based compensation, net restructuring expenses, net interest expense, income taxes, and depreciation and amortization from GAAP net income (loss). For purposes of this guidance, we have assumed that Ironwood will not incur material expenses related to business development activities in 2026. 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. 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. 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 and are 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, May 7th, 2026 to discuss its first quarter results and recent business activities. Individuals interested in participating in the call should dial (888) 596-4144 (U.S. and Canada) 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, May 7th, 2026, at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on Thursday, May 21st, 2026. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (609) 800-9909 (international) using conference ID number 3647053. The archived webcast will be available on Ironwood’s website for 1 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 6 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 adults with IBS-C or CIC. 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 AstraZeneca 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, and for the treatment of chronic idiopathic constipation (CIC) in adults, and for the treatment of functional constipation (FC) in pediatric patients 6 years of age and older. IMPORTANT SAFETY INFORMATION WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. 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 145 mcg and 290 mcg LINZESS-treated patients and in
US Market News
2 months ago
Ironwood Survey Findings at DDW 2026 Underscore Need for Therapies that Address Multiple Dimensions of Total Parenteral Nutrition (TPN) Burden in Short Bowel Syndrome (SBS)May 4, 2026 7:05 AM
Business Wire
– Surveyed HCPs identified reduction of days on TPN as a top priority –
– Improved quality of life, lower risk of infection and thrombosis viewed as key benefits of reduced TPN dependence –
– Additional presentations feature long-term apraglutide safety and tolerability data, new linaclotide data analyses across patient populations –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, presented new findings at Digestive Diseases Week® (DDW) 2026 from a survey assessing healthcare provider (HCP) perspectives on the use of total parenteral nutrition (TPN) in the treatment of short bowel syndrome (SBS). Surveyed HCPs emphasized the importance of reducing patient dependence on TPN to improve quality of life, reduce line infections and lower the risk of thrombosis. The majority (46.4%) identified reducing the number of days per week on TPN as a priority attribute of future therapies. An additional 30.1% prioritized reducing TPN hours per day, while fewer respondents (11.3%) prioritized reducing TPN volume.
SBS is a serious and chronic condition characterized by reduced absorptive capacity for fluids and/or nutrients, often requiring long-term dependence on parenteral support or PS (IV nutrition and/or IV hydration) to sustain life. Patients with SBS who are chronically dependent on PS, also referred to as SBS with intestinal failure (SBS-IF), frequently experience significant treatment burden, reduced quality of life and increased risk of severe complications such as infections. Despite current management approaches, substantial unmet need remains for therapies that reduce PS dependence and improve outcomes. An estimated 18,000 adult patients suffer from SBS-IF in the U.S., Europe and Japan, and have chronic dependence on PS.
“For many people living with short bowel syndrome, TPN is life-sustaining but can also profoundly affect quality of life. The LANDMARK survey shows that there remains a clear need for more therapies that further reduce TPN dependence,” said Syed-Mohammed R. Jafri, M.D., a gastroenterologist and transplant hepatologist with Detroit-based Henry Ford Health and lead author of the study. “While reducing TPN volume is still important, reducing the number of days on TPN may have a more meaningful impact on patients' lives.”
The survey findings also highlighted the significant burden associated with long-term TPN dependence among patients with SBS-IF. HCPs cited central line infections (59.8%), fatigue (47.9%), central line pain (43.2%), abdominal pain (40.5%), edema (37.5%) and thrombosis (29.5%) as the most common complications. Central line infections (49.7%) and central line pain (44.0%) were identified as the most distressing issues for patients. Nearly half of respondents (48.2%) cited central venous catheter related challenges – including infections, pain and thrombosis – as a primary limitation of TPN, followed by decreased quality of life (34.8%) and hepatotoxicity (32.4%).
“The survey findings underscore the real-world experience of patients suffering with SBS-IF while the endpoints in our STARS and STARS-2 clinical trials of apraglutide are designed to evaluate dimensions of parenteral support dependence, including reduction in TPN volume and increases in days off TPN,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “By staying grounded in real-world insights from HCPs – and patients – we can better focus on improving patient outcomes.”
In addition to the survey findings, Ironwood and its collaborators presented data from apraglutide and linaclotide studies. Key findings are summarized below.
Apraglutide Long-Term Safety Data
Data pooled from the STARS clinical program – including the Phase 2 STARS Nutrition study, STARS Phase 3 randomized placebo-controlled parent study and the ongoing open-label extension STARS Extend – demonstrated that apraglutide showed a well-tolerated long-term safety profile consistent with previous studies, low discontinuation rates due to TEAEs and no new safety observations.
Linaclotide Data
In pediatric patients aged 2-5 years with functional constipation, data from a Phase 3 open-label extension showed that linaclotide 72 mcg was well tolerated with no new safety signals. The majority of patients saw their FC symptoms resolve, with a low incidence of diarrhea.
In adults with IBS-C, a post-hoc analysis showed that linaclotide was associated with improved IBS-C symptoms across race, ethnicity and age subgroups. Safety outcomes were consistent with the established safety profile.
In adults with severe CIC, a post-hoc pooled analysis of Phase 3 studies showed that linaclotide 72 mcg or 145 mcg improved bowel movement frequency, stool consistency, straining and most abdominal symptoms, highlighting its ability to address both bowel function and symptom burden.
A post-hoc analysis showed that linaclotide demonstrated efficacy across key clinical endpoints in adults with CIC and IBS-C irrespective of pH-modifying agent use, and in IBS-C irrespective of pH-modifying agent use, with safety outcomes consistent with the known safety profile.
About the LANDMARK Survey
The LANDMARK disease burden survey is a cross-sectional study of HCPs, patients and caregivers assessing the real-world burden of SBS and PS dependence. The HCP survey recruited 336 participants (U.S., n=123; Europe, n=213) with two or more years of experience treating patients with SBS-IF and actively managing one or more patients. Respondents included physicians (42.0%), pharmacists (23.0%), and dietitians (18.0%), practicing primarily in gastroenterology (45.2%), clinical nutrition/nutritional support (23.5%) and internal medicine (17.3%).
About STARS and STARS-2
The STARS (STudy of ApRaglutide in SBS) pivotal Phase 3 clinical trial represents the largest Phase 3 clinical trial in SBS-IF to date.
This global, multicenter, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of weekly subcutaneous injections of apraglutide in adult patients with SBS-IF. STARS enrolled 164 patients and dosed 163 stratified approximately 50/50 (stoma vs. colon-in-continuity), then evaluated them over 24 weeks (stoma and colon-in-continuity populations) and 48 weeks (colon-in-continuity population only). Patients were randomized 2:1 to either once weekly apraglutide or placebo. The primary endpoint was relative change from baseline in actual weekly PS volume at week 24. Key secondary endpoints included patients who achieved a reduction from baseline of at least 1 day/week of PS at week 24 (all patients); relative change from baseline in actual weekly PS volume at week 24 (stoma population); patients who achieved a reduction from baseline of at least 1 day/week of PS at week 48 (colon-in-continuity population); and patients reaching enteral autonomy at week 48 (colon-in-continuity population). The study was conducted in 18 countries with 68 active sites.
STARS-2 is a planned confirmatory Phase 3 clinical trial of apraglutide for patients with SBS-IF. STARS-2 is planned to be a 24-week global, randomized, double-blind, placebo-controlled trial. The clinical trial will consist of a primary endpoint measuring relative change from baseline in actual weekly PS as well as additional key secondary endpoints.
About Apraglutide
Apraglutide is an investigational, next-generation, long-acting synthetic GLP-2 analog with the potential to treat a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology. Ironwood is advancing apraglutide for short bowel syndrome (“SBS”) patients dependent on parenteral support (“PS”), a severe chronic malabsorptive condition. As the first and only GLP-2 to achieve a statistically significant reduction in weekly parenteral support volume with once-weekly administration, Ironwood believes apraglutide has the potential to improve the standard of care for adult patients with SBS who are dependent on PS.
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 6 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 adults with IBS-C or CIC. 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 AstraZeneca 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 and for the treatment of chronic idiopathic constipation (CIC) in adults and for the treatment of functional constipation (FC) in children and adolescents 6 to 17 years of age.
IMPORTANT SAFETY INFORMATION
WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.
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
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 145 mcg and 290 mcg LINZESS-treated patients and in
US Market News
2 months ago
Ironwood Pharmaceuticals to Share Real-World HCP Perspectives on Burden of Total Parenteral Nutrition in Short Bowel Syndrome (SBS) at Digestive Disease Week® 2026April 23, 2026 7:05 AM
Business Wire
– Separate poster will feature long-term safety and tolerability data from STARS clinical trial program of apraglutide in adults with SBS who are dependent on parenteral support (PS) –
– Linaclotide data presentations highlight efficacy and safety insights in IBS-C, CIC and pediatric FC –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, announced today that the company will present data from its LANDMARK survey during the 2026 Digestive Disease Week® (DDW) meeting being held from May 2-5 in Chicago, IL. The data will spotlight healthcare professional (HCP) insights on the burden of total parenteral nutrition (TPN) for patients with short bowel syndrome (SBS), as well as preferred attributes for potential new therapies that reduce TPN dependence.
SBS is a serious and chronic condition characterized by reduced absorptive capacity for fluids and/or nutrients, often requiring long-term dependence on parenteral support (PS) (IV nutrition and/or IV hydration) to sustain life. Patients with SBS who are chronically dependent on PS, also referred to as SBS with intestinal failure (SBS-IF), frequently experience significant treatment burden, reduced quality of life and increased risk of severe complications such as infection. Despite current management approaches, substantial unmet need remains for therapies that reduce PS dependence and improve outcomes. An estimated 18,000 adult patients suffer from SBS-IF in the U.S., Europe and Japan, and have chronic dependence on PS.
Ironwood is advancing apraglutide, an investigational, next-generation, long-acting synthetic GLP-2 analog, for SBS patients dependent on PS.
“Short bowel syndrome remains a complex and underserved condition where patients and clinicians face significant challenges, particularly for those who rely on parenteral support, which is often life-sustaining but can be associated with substantial treatment burden,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “By bringing forward real-world healthcare professional perspectives, we aim to deepen understanding of current management and the factors that shape SBS-IF care in everyday practice and help inform future therapeutic approaches.”
In addition to the LANDMARK survey data, Ironwood will present long-term safety and tolerability data from the STARS clinical trial program of apraglutide in adults with SBS who are dependent on PS. Additional presentations include key findings from the company’s Phase 3 open-label safety extension study of linaclotide in pediatric patients aged 2–5 years with functional constipation, as well as analyses in adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
A full list of the poster presentations is below.
Short Bowel Syndrome
“Burden of Total Parenteral Nutrition for Patients with Short Bowel Syndrome Dependent on Parenteral Support: Healthcare Professional Perspectives on Risks, Limitations, and Treatment Priorities” (Sunday, May 03, 12:30 pm CT) will be presented by Mena Boules, M.D., Ironwood Pharmaceuticals.
“Long-Term Safety and Tolerability of Once-Weekly Apraglutide in Patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF)” (Sunday, May 03, 12:30 pm CT) will be presented by Palle Bekker Jeppesen, M.D., Dr.med/Sci., Ph.D., dls., Rigshospitalet, Copenhagen.
IBS-C, CIC and Functional Constipation
“Effect of pH-Modifying Agents on the Efficacy and Safety of Linaclotide in Adults with Chronic Idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C): A Post Hoc Analysis” (Saturday, May 02, 12:30 pm CT) will be presented by Satish SC Rao, M.D., Ph.D., FRCP (LON), FACG, AGAF, Augusta University.
“Safety and Efficacy of Linaclotide in Pediatric Patients Aged 2–5 Years with Functional Constipation (FC): Results from an Open-Label Safety Extension of a Phase 3 Study” (Monday, May 04, 12:30 pm CT) will be presented by Carlo Di Lorenzo, M.D., Nationwide Children’s Hospital.
“Efficacy and Safety of Linaclotide in Irritable Bowel Syndrome with Constipation (IBS-C): A Phase 3 Post Hoc Analysis by Race, Ethnicity and Age” (Saturday, May 02, 12:30 pm CT) will be presented by Aditya Ashok, M.D., Weill Cornell Medical College.
“Linaclotide Efficacy in Adults with Severe Chronic Idiopathic Constipation (CIC): A Post Hoc Pooled Analysis of Phase 3 Studies” (Monday, May 04, 12:30 pm CT) will be presented by Anthony J. Lembo, M.D., Digestive Disease Institute, Cleveland Clinic.
About the LANDMARK Survey
The LANDMARK disease burden survey is a cross-sectional study of HCPs, patients and caregivers assessing the real-world burden of SBS and PS dependence. The HCP survey recruited 336 participants (U.S., n=123; Europe, n=213) with two or more years of experience treating patients with SBS-IF and actively managing one or more patients. Respondents included physicians (42.0%), pharmacists (23.0%) and dietitians (18.0%), practicing primarily in gastroenterology (45.2%), clinical nutrition/nutritional support (23.5%) and internal medicine (17.3%).
About Apraglutide
Apraglutide is an investigational, next-generation, long-acting synthetic GLP-2 analog with the potential to treat a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology. Ironwood is advancing apraglutide for short bowel syndrome (“SBS”) patients dependent on parenteral support (“PS”), a severe chronic malabsorptive condition. As the first and only GLP-2 to achieve a statistically significant reduction in weekly parenteral support volume with once-weekly administration, Ironwood believes apraglutide has the potential to improve the standard of care for adult patients with SBS who are dependent on PS.
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 6 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 adults with IBS-C or CIC. 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 AstraZeneca 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 and for the treatment of chronic idiopathic constipation (CIC) in adults and for the treatment of functional constipation (FC) in children and adolescents 6 to 17 years of age.
IMPORTANT SAFETY INFORMATION
WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.
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
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 145 mcg and 290 mcg LINZESS-treated patients and in
US Market News
4 months ago
Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Results; Achieves 2025 Financial Guidance and Reiterates Strong 2026 OutlookFebruary 25, 2026 7:05 AM
Business Wire
– LINZESS® (linaclotide) EUTRx demand growth of 11% for full year 2025 year-over-year –
– 2025 Ironwood revenue of $296 million, GAAP net income of $24 million and adjusted EBITDA of $138 million –
– Continue to expect full-year 2026 LINZESS® U.S. net sales of $1.125 to $1.175 billion; total revenues of $450 to $475 million and adjusted EBITDA of greater than $300 million –
– Key elements of confirmatory Phase 3 clinical trial design of apraglutide in short bowel syndrome with intestinal failure (SBS-IF) have been finalized with site initiations expected to begin in the second quarter of 2026 –
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 fourth quarter and full-year 2025 results and recent business performance.
“In 2025, LINZESS delivered 11% EUTRx demand growth year-over-year, continuing to strengthen its position as the prescription market leader for the treatment of IBS-C and CIC, surpassing 5.7 million unique patients treated since launch. Additionally, throughout 2025 our disciplined approach to expense management allowed us to navigate LINZESS pricing headwinds, deliver $24 million in GAAP net income and $138 million in adjusted EBITDA and generate $127 million in cash flow from operations,” said Tom McCourt, chief executive officer of Ironwood. “Importantly, we ended 2025 with $215 million in cash and cash equivalents, positioning Ironwood well for 2026.”
“As we enter 2026, we remain focused on our core priorities of maximizing LINZESS, advancing apraglutide and delivering sustained profits and cash flows. We believe our full-year 2026 financial guidance demonstrates the significant progress we’ve made across these priorities and our ability to drive increasing shareholder value. In 2026, we expect increased LINZESS U.S. Net Sales and disciplined expense management to drive greater than $300 million in adjusted EBITDA, enabling us to continue advancing apraglutide and reduce our debt to further strengthen our financial position. We believe apraglutide has the potential to redefine the standard of care for patients living with SBS-IF and look forward to initiating sites for the confirmatory Phase 3 clinical trial, STARS-2, in the second quarter of this year. With an improved financial position, we now have a clear path to execute our strategy, and we continue to evaluate all options to maximize shareholder value.”
Fourth Quarter and Full Year 2025 Financial Highlights1
(in thousands, except for per share amounts)
Q4 2025
Q4 2024
FY 2025
FY 2024
Total revenue2
$47,709
$90,545
296,151
$351,410
Total costs and expenses
40,904
59,054
197,649
258,286
GAAP net income (loss)2
(2,276)
2,256
24,017
880
GAAP net income (loss) – per share basic and diluted2
(0.01)
0.01
0.15
0.01
Adjusted EBITDA2, 3
10,913
37,256
138,083
129,364
Non-GAAP net income (loss)2
(2,274)
2,536
40,091
4,980
Non-GAAP net income (loss) per share – basic and diluted2
(0.01)
0.01
0.25
0.04
1 Refer to the Reconciliation of GAAP Results to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA table at the end of this press release. Refer to Non-GAAP Financial Measures for additional information.
2 Figures presented for the fourth quarter of 2024 collaboration revenue to Ironwood includes a $7.2 million positive adjustment to reflect Ironwood’s estimate of LINZESS gross-to-net reserves as of December 31, 2024.
3 Adjusted EBITDA is calculated by subtracting restructuring expenses, net interest expense, income taxes, depreciation and amortization and stock-based compensation, from GAAP net income (loss). The exclusion of stock-based compensation from Adjusted EBITDA represents an update to our definition of Adjusted EBITDA, effective in the first quarter of 2025. For comparison purposes, fourth quarter and full year 2024 Adjusted EBITDA have also been updated to reflect this updated definition.
Fourth Quarter and Full Year 2025 Corporate Highlights
Apraglutide
Apraglutide is a once weekly, long-acting synthetic glucagon-like peptide-2 (“GLP-2”) analog with the potential to treat a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology.
Ironwood is advancing apraglutide for short bowel syndrome (“SBS”) patients dependent on parenteral support (“PS”), a severe chronic malabsorptive condition. Ironwood believes apraglutide has the potential 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 parenteral support volume with once-weekly administration.
Ironwood met with the U.S. Food and Drug Administration (“FDA”) in the fourth quarter of 2025 and aligned on key design elements of a confirmatory Phase 3 clinical trial (“STARS-2”) for patients with SBS-IF. STARS-2 is planned to be a 24-week global, randomized, double-blind, placebo-controlled trial. The clinical trial will consist of a primary endpoint measuring relative change from baseline in actual weekly PS volume as well as additional key secondary endpoints. Site initiations are expected to begin in the second quarter of 2026.
U.S. LINZESS
Label Expansion: In November, the FDA approved LINZESS for the treatment of irritable bowel syndrome with constipation (IBS-C) in patients aged 7 years of age and older. In addition to expanding its clinical utility, this new indication establishes LINZESS as the first and only prescription drug approved for the treatment of IBS-C in patients 7-17 years old.
Prescription Demand: Total LINZESS prescription demand in the fourth quarter of 2025 was 63 million LINZESS capsules, a 13% increase compared to the fourth quarter of 2024, per IQVIA. Total prescription demand was 234 million LINZESS capsules for the full year 2025, a 11% increase compared to the full year 2024, per IQVIA.
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 $163.2 million in the fourth quarter of 2025, a 27% decrease compared to $223.0 million in the fourth quarter of 2024, and $864.5 million for the full year 2025, a 6% decrease compared to $916.3 million for the full year 2024. Ironwood and AbbVie share equally in U.S. brand collaboration profits.
Fourth quarter 2025 LINZESS U.S. net sales decrease year-over-year was driven by unfavorable quarterly phasing of gross-to-net rebate reserves and increased net pricing headwinds associated with Medicare Part D redesign. As a reminder, gross-to-net rebate reserves in 2025 are based on rebates owed for units dispensed by channel in each applicable quarter. In its first quarter 2025 results, Ironwood stated that it expects gross-to-net rebate reserves based on units dispensed to impact quarterly phasing of 2025 LINZESS U.S. net sales.
LINZESS commercial margin was 54% in the fourth quarter of 2025, compared to 64% in the fourth quarter of 2024. LINZESS commercial margin was 66% for the full year in 2025 and 66% for the full year in 2024. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release.
Net profit for the LINZESS U.S. brand collaboration, net of commercial and research and development (“R&D”) expenses, was $81.5 million in the fourth quarter of 2025, a 40% decrease compared to $135.2 million in the fourth quarter of 2024. Net profit for LINZESS U.S. brand collaboration, net of commercial and R&D expenses, was $545.4 million for the full year 2025, a 4% decrease compared to $570.9 million for the full year 2024. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release.
Collaboration Revenue to Ironwood: Ironwood recorded $45.2 million in collaboration revenue in the fourth quarter of 2025 related to sales of LINZESS in the U.S., a 49% decrease compared to $88.4 million for the fourth quarter of 2024. Fourth quarter of 2024 collaboration revenue to Ironwood includes a $7.2 million positive adjustment to reflect Ironwood’s estimate of LINZESS gross-to-net reserves as of December 31, 2024. Ironwood recorded $289.3 million in collaboration revenue for the full year 2025 related to the sales of LINZESS in the U.S., a 15% decrease compared to $340.4 million in 2024. See the U.S. LINZESS Commercial Collaboration table at the end of the press release.
Corporate Updates
In December 2025, Ironwood, VectivBio AG and Ferring International Center S.A. (“Ferring”) entered into a license amendment and a settlement agreement and release pursuant to which the parties have settled all claims between the parties arising out of Ferring’s complaint filed in the U.S. District Court in the Eastern District of Texas. As part of the agreed-upon license amendment, Ironwood agreed to pay Ferring $12.5 million. Ironwood paid $7.5 million in December 2025 and is obligated to pay the remaining $5.0 million on or by December 31, 2026, subject to accelerated payment in certain circumstances.
Fourth Quarter and Full Year 2025 Financial Results
Total Revenue. Total revenue in the fourth quarter of 2025 was $47.7 million, compared to $90.5 million in the fourth quarter of 2024. Total revenue for the full year 2025 was $296.2 million, compared to $351.4 million for the full year 2024.
Total revenue in the fourth quarter of 2025 consisted of $45.2 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., and $2.5 million in royalties and other revenue. Total revenue in the fourth quarter of 2024 consisted of $88.4 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., and $2.1 million in royalties and other revenue.
Total revenue for the full year 2025 consisted of $289.3 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S. and $6.9 million in royalties and other revenue. Total revenue for the full year 2024 consisted of $340.4 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S. and $11.0 million in royalties and other revenue.
Total Costs and Expenses. Total costs and expenses in the fourth quarter of 2025 were $40.9 million, compared to $59.1 million in the fourth quarter of 2024. Total costs and expenses for the full year 2025 were $197.6 million, compared to $258.3 million for the full year 2024.
Total costs and expenses in the fourth quarter of 2025 consisted of $19.3 million in selling, general and administrative (“SG&A”) expenses, $21.9 million in R&D expenses, and reversal of $0.3 million in restructuring expenses. Total costs and expenses in the fourth quarter of 2024 consisted of $33.6 million in SG&A expenses, $25.4 million in R&D expenses, and $0.1 million in restructuring expenses.
In connection with the Ferring settlement, Ironwood recorded a charge of $5.0 million as SG&A expense in the consolidated statements of income during the fourth quarter of 2025.
Total costs and expenses for the full year 2025 consisted primarily of $82.3 million in SG&A expenses, $95.1 million in R&D expenses, and $20.3 million in restructuring expenses. Total costs and expenses for the full year 2024 consisted primarily of $144.3 million in SG&A expenses, $111.4 million in R&D expenses, and $2.6 million in restructuring expenses.
In connection with the Ferring settlement, Ironwood recorded a charge of $12.5 million as SG&A expense in the consolidated statements of income during the year ended December 31, 2025.
Interest Expense. Interest expense was $7.9 million in the fourth quarter of 2025 and $32.7 million for the full year in 2025, in connection with Ironwood’s convertible senior notes and revolving credit facility. Interest expense was $8.9 million in the fourth quarter of 2024 and $33.0 million for the full year 2024, in connection with Ironwood’s convertible senior notes and revolving credit facility.
Interest and Investment Income. Interest and investment income was $1.5 million in the fourth quarter of 2024 and $4.1 million for the full year 2025. Interest and investment income was $0.8 million in the fourth quarter of 2024 and $4.5 million for the full year 2024.
Other. Other income was $0.1 million in the fourth quarter of 2025 and $0.2 million for the full year 2025 driven by a gain recorded for pension-related activities. Other income was $0.6 million in the fourth quarter of 2024 and for the full year 2024 driven by a gain recorded for pension-related activities.
Income Tax Expense. Ironwood recorded $2.7 million of income tax expense in the fourth quarter of 2025 and $46.0 million of income tax expense for the full year 2025, 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 $21.7 million of income tax expense in the fourth quarter of 2024 and $64.3 million of income tax expense for the full year 2024, 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 (Loss). GAAP net loss was $2.3 million, or $(0.01) per share (basic and diluted) in the fourth quarter of 2025, compared to GAAP net income of $2.3 million, or $0.01 per share (basic and diluted) in the fourth quarter of 2024. GAAP net income for the full year 2025 was $24.0 million, or $0.15 per share (basic and diluted), compared to GAAP net income of $0.9 million, or $0.01 per share (basic and diluted), for the full year 2024.
Non-GAAP Net Income (Loss). Non-GAAP net loss was $2.3 million, or $(0.01) per share (basic and diluted), in the fourth quarter of 2025, compared to non-GAAP net income of $2.5 million, or $0.01 per share (basic and diluted), in the fourth quarter of 2024. Non-GAAP net income for the full year 2025 was $40.1 million, or $0.25 per share (basic and diluted), compared to non-GAAP net income of $5.0 million, or $0.04 per share (basic and diluted), for the full year 2024.
Non-GAAP net income excludes the impact of amortization of acquired intangible assets, restructuring expenses and acquisition-related costs, all net of tax effect. See Non-GAAP Financial Measures below.
Adjusted EBITDA. Adjusted EBITDA was $10.9 million in the fourth quarter of 2025, compared to $37.3 million in the fourth quarter of 2024. For the full year 2025, adjusted EBITDA was $138.1 million, compared to $129.4 million for the full year 2024.
Adjusted EBITDA is calculated by subtracting stock-based compensation, restructuring expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related costs, from GAAP net income (loss). See Non-GAAP Financial Measures below.
Cash Flow Highlights. Ironwood ended the fourth quarter of 2025 with $215.5 million of cash and cash equivalents, compared to $88.6 million of cash and cash equivalents at the end of 2024.
The outstanding principal balance on the revolving credit facility was $385.0 million as of December 31, 2025.
Ironwood generated $74.6 million in cash from operations in the fourth quarter of 2025, compared to $15.2 million in cash from operations in the fourth quarter of 2024. Ironwood generated $127.0 million in cash from operations for the full year 2025, compared to $103.5 million for the full year 2024.
Ironwood 2026 Financial Guidance. Ironwood continues to expect:
2026 Guidance
(February 2026)
U.S. LINZESS Net Sales
$1.125 - $1.175 billion
Driven by improved net price and low-single digit percentage demand growth
Total Revenue1
$450 - $475 million
Adjusted EBITDA2
>$300 million
1 Ironwood’s U.S. collaborative arrangements revenue includes reimbursement from AbbVie for a portion of Ironwood’s commercial expenses related to sales of LINZESS in the U.S.
2 Adjusted EBITDA is calculated by subtracting stock-based compensation, restructuring expenses, net interest expense, income taxes, and depreciation and amortization, from GAAP net income (loss). For purposes of this guidance, we have assumed that Ironwood will not incur material expenses related to business development activities in 2026. 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. 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.
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, restructuring expenses, and acquisition-related costs, 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 and are 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.
Acquisition-related costs in connection with the acquisition of VectivBio are considered to be non-recurring and include direct and incremental costs associated with the acquisition and integration of VectivBio to the extent such costs were not classified as capitalizable transaction costs attributed to the cost of net assets acquired through acquisition accounting.
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, restructuring expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related costs from GAAP net income. 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 Wednesday, February 25th, 2026 to discuss its fourth quarter and full year 2025 results and recent business activities. Individuals interested in participating in the call should dial (888) 596-4144 (U.S. and Canada) or (646) 968-2525 (international) using conference ID number and event passcode 2530602. 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 Wednesday, February 25th, 2026, at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on Wednesday, March 11, 2026. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (609) 800-9909 (international) using conference ID number 2530602. The archived webcast will be available on Ironwood’s website for 1 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 Short Bowel Syndrome (SBS)
SBS is a serious and chronic condition where there is diminished absorptive capacity for fluids and/or nutrients, sometimes requiring dependence on parenteral support to maintain health. SBS typically occurs because of extensive intestinal resection, and patients with SBS who are chronically dependent on parenteral support, also referred to as SBS with intestinal failure (SBS-IF), often experience significant quality of life impact and are at risk of severe complications such as infection. An estimated 18,000 adult patients suffer from SBS-IF in the U.S., Europe and Japan, and have chronic dependence on PS, which significantly impacts quality of life and carries the risk of severe complications such as infection. Those with the most severe SBS-IF require PS infusions for up to 10 to 15 hours per day. SBS-IF is associated with frequent complications, significant morbidity and mortality, high economic burden and an impaired quality of life.
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 6 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 adults with IBS-C or CIC. 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 AstraZeneca 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 and for the treatment of chronic idiopathic constipation (CIC) in adults and for the treatment of functional constipation (FC) in children and adolescents 6 to 17 years of age.
IMPORTANT SAFETY INFORMATION
WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.
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
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 145 mcg and 290 mcg LINZESS-treated patients and in
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