Ironwood(IRWD) - 2025 Q1 - Quarterly Results

Financial Performance and Guidance 2025 Financial Guidance Ironwood Pharmaceuticals reiterated LINZESS U.S. net sales and total revenue guidance for 2025, while raising adjusted EBITDA due to strategic spending shifts Updated 2025 Financial Guidance (April 2025) | Guidance Metric | Prior 2025 Guidance (Feb 2025) | Updated 2025 Guidance (Apr 2025) | | :--- | :--- | :--- | | U.S. LINZESS Net Sales | $800 - $850 million | $800 - $850 million | | Total Revenue | $260 - $290 million | $260 - $290 million | | Adjusted EBITDA | >$85 million | >$105 million | - The increase in adjusted EBITDA guidance is a result of the company no longer planning certain apraglutide commercial launch investments and shifting focus to the confirmatory Phase 3 trial following recent FDA feedback[3] - The definition of Adjusted EBITDA was updated in Q1 2025 to exclude stock-based compensation, calculated by subtracting specific expenses from GAAP net income[7] Q1 2025 Performance Highlights LINZESS Q1 2025 prescription demand grew 8% year-over-year, though U.S. net sales decreased 46% due to pricing and rebate adjustments LINZESS Q1 2025 Performance vs. Q1 2024 | Metric | Q1 2025 | Change vs. Q1 2024 | | :--- | :--- | :--- | | Prescription Demand Growth (YoY) | 8% | N/A | | U.S. Net Sales | $138.5 million | -46% | - The strong 8% year-over-year prescription demand growth in Q1 2025 is in line with the company's full-year expectations[2][3][4] - The significant drop in Q1 2025 net sales was impacted by a change in AbbVie's estimate of gross-to-net rebate reserves, expected to affect quarterly phasing but not full-year results[3][8] Corporate and Product Information About Ironwood Pharmaceuticals Ironwood Pharmaceuticals is a biotechnology company specializing in therapies for gastrointestinal (GI) and rare diseases, with LINZESS as its flagship product and apraglutide in development - The company focuses on developing and commercializing therapies for people with gastrointestinal (GI) and rare diseases[9] - Ironwood is advancing apraglutide, a long-acting synthetic GLP-2 analog, for short bowel syndrome[9] - The company was founded in 1998 and is headquartered in Boston, Massachusetts, with an additional site in Basel, Switzerland[10] About LINZESS (Linaclotide) LINZESS (linaclotide) is the leading U.S. prescription for IBS-C and CIC in adults, and functional constipation in children, acting as a first-in-class GC-C agonist - LINZESS is the 1 prescribed brand in the U.S. for adults with IBS-C or CIC[11] - It is the first FDA-approved medicine in the GC-C agonist class, which is distinct from laxatives[12] - Ironwood co-develops and co-commercializes LINZESS with AbbVie in the U.S. and partners with Astellas (Japan) and AstraZeneca (China) for other major markets[13] LINZESS Important Safety Information This section outlines crucial safety details for LINZESS, including its approved uses, contraindications, and key warnings, notably a boxed warning for pediatric dehydration Indications and Usage LINZESS is indicated for adults with IBS-C and CIC, and for children aged 6 to 17 with functional constipation - Indicated for adults with IBS-C and CIC[14] - Indicated for children and adolescents (6 to 17 years) with functional constipation (FC)[14] Warnings and Precautions LINZESS carries a boxed warning for serious dehydration risk in pediatric patients under 2 years old and is contraindicated in this age group, as well as in cases of mechanical gastrointestinal obstruction - BOXED WARNING: LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration, based on deaths observed in nonclinical neonatal mice studies[15][16] - The drug is also contraindicated in patients with known or suspected mechanical gastrointestinal obstruction[18] Common Adverse Reactions The most common adverse reaction for LINZESS in both adult and pediatric trials was diarrhea, with other common reactions in adults including abdominal pain, flatulence, and abdominal distension - Diarrhea was the most common adverse reaction in both adult (IBS-C/CIC) and pediatric (FC) patient trials[19] - In adult patients, other common adverse reactions (≥2% and greater than placebo) included abdominal pain, flatulence, and abdominal distension[19] Disclosures Forward-Looking Statements This section cautions investors that forward-looking statements, including financial guidance and clinical plans, are subject to risks and uncertainties, with actual results potentially differing materially - Cautions investors not to place undue reliance on forward-looking statements related to financial guidance, LINZESS performance, and apraglutide development[21] - Highlights that actual results may differ materially due to risks such as clinical development outcomes, pricing and reimbursement policies, competition, and patent protection[21] - Refers investors to the "Risk Factors" section in the company's Annual Report on Form 10-K for a full disclosure of applicable risks[21]