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Ironwood Pharmaceuticals Reports Strong Third Quarter 2025 Results; Raises Full Year 2025 Financial Guidance<\/b><\/p>\n
\u2013 LINZESS\u00ae<\/sup> (linaclotide) U.S. net sales of $315 million in Q3 2025, an increase of 40% year-over-year; EUTRx demand growth increased 12% year-over-year \u2013<\/i><\/p>\n \u2013 GAAP net income of $40 million and adjusted EBITDA of $82 million in Q3 2025; ended Q3 2025 with $140 million in cash and cash equivalents \u2013<\/i><\/p>\n \u2013 Raises full-year 2025 LINZESS U.S. net sales guidance to $860 – $890 million; total revenue guidance to $290 – $310 million and adjusted EBITDA guidance to greater than $135 million \u2013<\/i><\/p>\n \u2013 FDA approves LINZESS as the first drug for the treatment of children 7 years and older with irritable bowel syndrome with constipation (IBS-C) \u2013<\/i><\/p>\n BOSTON–(BUSINESS WIRE<\/a>)–Ironwood Pharmaceuticals, Inc.<\/a> (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today reported its third quarter 2025 results and recent business performance.<\/p>\n \n\u201cLINZESS delivered a strong third-quarter performance, driven by accelerated double-digit prescription demand growth combined with improved net pricing, which prompted us to raise our full-year 2025 financial guidance. Importantly, we expect our strong third-quarter revenue will result in substantial fourth-quarter cash flows, which will strengthen our financial position, enable us to reduce our debt and maintain compliance with debt covenants over the coming quarters,\u201d said Tom McCourt, chief executive officer of Ironwood.<\/p>\n \n\u201cAs part of our ongoing commitment to patients, we continue to seek ways to expand the clinical utility of LINZESS. This month, the FDA approved LINZESS for the treatment of IBS-C in patients 7 years of age and older. We also remain focused on advancing the apraglutide program toward a confirmatory Phase 3 trial, with plans to align on a trial design with the FDA later this year. Pending that alignment, we expect to initiate a Phase 3 confirmatory study in the first half of 2026. In addition, we continue to review strategic alternatives to maximize shareholder value and look forward to providing an update on that process as appropriate,\u201d added Tom McCourt.<\/p>\n Third Quarter 2025 Financial Highlights1 \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n Q3 2025<\/span><\/b><\/p>\n<\/td>\n Q3 2024<\/span><\/b><\/p>\n<\/td>\n<\/tr>\n \nTotal revenue 2<\/sup><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$122,060<\/p>\n<\/td>\n \n$91,592<\/p>\n<\/td>\n<\/tr>\n \nTotal costs and expenses<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n46,576<\/p>\n<\/td>\n \n65,956<\/p>\n<\/td>\n<\/tr>\n \nGAAP net income 2<\/sup><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n40,080<\/p>\n<\/td>\n \n3,646<\/p>\n<\/td>\n<\/tr>\n \nGAAP net income \u2013 per share basic 2<\/sup><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n0.25<\/p>\n<\/td>\n \n0.02<\/p>\n<\/td>\n<\/tr>\n \nGAAP net income \u2013 per share diluted 2<\/sup><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n0.23<\/p>\n<\/td>\n \n0.02<\/p>\n<\/td>\n<\/tr>\n \nAdjusted EBITDA 2,3<\/sup><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n81,811<\/p>\n<\/td>\n \n34,488<\/p>\n<\/td>\n<\/tr>\n \nNon-GAAP net income 2<\/sup><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n41,933<\/p>\n<\/td>\n \n3,869<\/p>\n<\/td>\n<\/tr>\n \nNon-GAAP net income per share \u2013 basic 2<\/sup><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n0.26<\/p>\n<\/td>\n \n0.02<\/p>\n<\/td>\n<\/tr>\n \nNon-GAAP net income per share \u2013 diluted 2<\/sup><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n0.24<\/p>\n<\/td>\n \n0.02<\/p>\n<\/td>\n<\/tr>\n 1<\/sup>Refer to the Reconciliation of GAAP Results to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Income to Adjusted EBITDA table at the end of this press release. Refer to Non-GAAP Financial Measures for additional information. Third Quarter 2025 Corporate Highlights<\/b><\/p>\n Apraglutide<\/b><\/p>\n U.S. LINZESS<\/b><\/p>\n \n\u2013 Third quarter LINZESS U.S. net sales growth year-over-year was driven by improved net pricing and strong 12% demand growth in the quarter. 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 and this dynamic led to a favorable year-over-year net price in the third quarter of 2025.<\/p>\n \n\u2013 LINZESS commercial margin was 76% in the third quarter of 2025, compared to 65% in the third quarter of 2024. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release.<\/p>\n \n\u2013 Net profit for the LINZESS U.S. brand collaboration, net of commercial and research and development (\u201cR&D\u201d) expenses, was $233.1 million in the third quarter of 2025, a 67% increase compared to $139.6 million in the third quarter of 2024. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release.<\/p>\n Corporate Updates<\/b><\/p>\n Third Quarter 2025 Financial Results<\/b><\/p>\n \n\u2013 Total revenue in the third quarter of 2025 consisted of $119.6 million associated with Ironwood\u2019s 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 third quarter of 2024 consisted of $88.9 million associated with Ironwood\u2019s share of the net profits from the sales of LINZESS in the U.S., and $2.7 million in royalties and other revenue.<\/p>\n \n\u2013 Total costs and expenses in the third quarter of 2025 consisted of $21.9 million in selling, general and administrative (\u201cSG&A\u201d) expenses, $22.5 million in R&D expenses, and $2.2 million in restructuring expenses. Total costs and expenses in the third quarter of 2024 consisted of $36.1 million in SG&A expenses, $29.8 million in R&D expenses, and an insignificant amount in restructuring expenses.<\/p>\n \n\u2013 Third quarter 2025 SG&A expenses include an estimated $7.5 million litigation contingency reserve associated with the litigation referenced above.<\/p>\n \n\u2013 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.<\/p>\n \n\u2013 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.<\/p>\n \n\u2013 The outstanding principal balance on the revolving credit facility was $385.0 million as of September 30, 2025.<\/p>\n \n\u2013 Ironwood generated $47.6 million in cash from operations in the third quarter of 2025, compared to $9.9 million in cash from operations in the third quarter of 2024.<\/p>\n \n\u00a0<\/p>\n<\/td>\n Prior 2025<\/b><\/p>\n Guidance<\/b><\/p>\n \n(August 2025)<\/p>\n<\/td>\n Updated 2025<\/b><\/p>\n Guidance<\/b><\/p>\n \n(November 2025)<\/p>\n<\/td>\n<\/tr>\n \nU.S. LINZESS Net Sales<\/p>\n<\/td>\n \n$800 – $850 million<\/p>\n<\/td>\n \n$860 – $890 million<\/p>\n<\/td>\n<\/tr>\n \nTotal Revenue1<\/sup><\/p>\n<\/td>\n \n$260 – $290 million<\/p>\n<\/td>\n \n$290 – $310 million<\/p>\n<\/td>\n<\/tr>\n \nAdjusted EBITDA2<\/sup><\/p>\n<\/td>\n \n>$105 million<\/p>\n<\/td>\n \n>$135 million<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\u2013 In the fourth quarter, Ironwood expects continued strong LINZESS prescription demand growth to be more than offset by reduced net price associated with unfavorable quarterly phasing of gross-to-net rebate reserves and increased Medicare Part D redesign impact as compared to third quarter of 2025.<\/p>\n 1<\/sup> Ironwood\u2019s U.S. collaborative arrangements revenue includes reimbursement from AbbVie for a portion of Ironwood\u2019s commercial expenses related to sales of LINZESS in the U.S. The FY2025 total revenue guidance accounts for the impact of the reduction to Ironwood\u2019s commercial expenses and corresponding reimbursement from AbbVie due to Ironwood\u2019s strategic reorganization announced in January 2025. Non-GAAP Financial Measures<\/b><\/p>\n \nIronwood 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:<\/p>\n \nIronwood 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.<\/p>\n \nManagement believes this non-GAAP information is useful for investors, taken in conjunction with Ironwood\u2019s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood\u2019s 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.<\/p>\n \nIronwood 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.<\/p>\n About Ironwood Pharmaceuticals<\/b><\/p>\n \nIronwood 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\u00ae (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.<\/p>\n \nFounded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland.<\/p>\n \nWe routinely post information that may be important to investors on our website at www.ironwoodpharma.com<\/a>. In addition, follow us on X<\/a> and on LinkedIn<\/a>.<\/p>\n About LINZESS (Linaclotide)<\/b><\/p>\n \nLINZESS\u00ae is the #1 prescribed brand in the U.S. for the treatment of patients with irritable bowel syndrome with constipation (\u201cIBS-C\u201d) or chronic idiopathic constipation (\u201cCIC\u201d), 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.<\/p>\n \nLINZESS 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.<\/p>\n \nIn 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\u00ae 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.<\/p>\n LINZESS Important Safety Information<\/b><\/p>\n INDICATIONS AND USAGE<\/b><\/p>\n \nLINZESS\u00ae (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.<\/p>\n IMPORTANT SAFETY INFORMATION<\/b><\/p>\n WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE<\/b><\/p>\n \n\u00a0<\/p>\n 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.<\/b><\/p>\n<\/td>\n<\/tr>\n<\/table>\n Contraindications<\/b><\/p>\n
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2 <\/sup>Figures presented for the third quarter of 2024 include a $5.8 million increase to collaborative arrangement revenues as a result of an adjustment recorded for Ironwood\u2019s estimate of LINZESS gross-to-net reserves as of September 30, 2024.
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3<\/sup> Adjusted EBITDA is calculated by subtracting restructuring expenses, net interest expense, income taxes, depreciation and amortization and stock-based compensation, from GAAP net income. 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, third quarter 2024 Adjusted EBITDA has also been updated to reflect this updated definition.<\/p>\n\n
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2<\/sup> Adjusted EBITDA is calculated by subtracting restructuring expenses, net interest expense, income taxes, depreciation and amortization and stock-based compensation, from GAAP net income. 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 purposes of this guidance, we have assumed that Ironwood will not incur material expenses related to business development activities in 2025. 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\u2019s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood\u2019s 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.<\/p>\n\n
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