Core Viewpoint - Ironwood Pharmaceuticals (IRWD) shares dropped 31.5% following regulatory updates regarding apraglutide, a next-generation GLP-2 analog for treating short bowel syndrome with intestinal failure [1][7] Company Performance - Year-to-date, Ironwood shares have decreased by 85.4%, significantly underperforming the industry, which declined by 9.8% [3] Recent Development Activities - The phase III STARS study assessed apraglutide's effectiveness in reducing parenteral support dependency in adult patients with short bowel syndrome and intestinal failure [4] - A rolling new drug application (NDA) submission for apraglutide was initiated in January 2025, with completion expected in the third quarter of 2025 [5][4] - A recent discussion with the FDA indicated that a confirmatory phase III study is now required for apraglutide's approval, potentially delaying the NDA filing and approval timeline [7] Strategic Moves - Ironwood is exploring alternatives to maximize shareholder value amidst the recent challenges [2] - The company acquired the rights to develop and commercialize apraglutide through the acquisition of VectivBio in June 2023 [8]

Core Viewpoint - Ironwood Pharmaceuticals is required by the FDA to conduct a confirmatory Phase 3 trial for apraglutide to gain approval for treating short bowel syndrome with intestinal failure [1][2][5] Group 1: FDA Requirements and Trials - The FDA has indicated that a confirmatory Phase 3 trial is necessary for the approval of apraglutide, following a recent dialogue with the company [2][3] - Pharmacokinetic analysis revealed that the exposure and dose delivered in the STARS Phase 3 trial were lower than planned due to issues in dose preparation and administration [2] - Ironwood plans to collaborate with the FDA to design the confirmatory Phase 3 trial and outline the regulatory path forward [3] Group 2: Clinical Data and Efficacy - Apraglutide demonstrated strong safety and efficacy data in the STARS Phase 3 trial, with 27 patients dependent on parenteral support achieving enteral autonomy, which is a key goal for these patients [4] - The company intends to continue the long-term extension trial, believing that data from the STARS trial will be crucial for the new drug application (NDA) submission [4] Group 3: Company Response and Market Impact - The CEO of Ironwood expressed disappointment regarding the FDA's requirement for an additional trial, emphasizing the potential value of apraglutide for patients suffering from short bowel syndrome with intestinal failure [5] - Ironwood has initiated a rolling NDA submission for apraglutide, with completion expected in Q3 2025 [5] - Following the announcement, Ironwood's stock price fell by 30.28%, trading at 66 cents [5]

Group 1 - The article discusses the author's long-standing interest in Ironwood Pharmaceuticals, particularly in relation to its potential in the biotech sector [1] - The author emphasizes the focus on innovative companies that are developing breakthrough therapies and pharmaceuticals, indicating a strategic investment approach [1] - The article highlights the features of the author's investment group, Compounding Healthcare, which includes model healthcare portfolios and a weekly newsletter [1] Group 2 - The author has disclosed a beneficial long position in ABBV shares, indicating a personal investment interest [2] - The article clarifies that the opinions expressed are solely those of the author and not influenced by any business relationships with mentioned companies [2] - It is noted that past performance does not guarantee future results, emphasizing the speculative nature of investments [3]

Ironwood Pharmaceuticals (IRWD) reported adjusted earnings of 2 cents per share for the fourth quarter of 2024, missing the Zacks Consensus Estimate of 10 cents. The company had recorded break-even earnings in the year-ago quarter.See the Zacks Earnings Calendar to stay ahead of market-making news.Total revenues in the fourth quarter were $90.5 million, which also missed the Zacks Consensus Estimate of $92 million. The top line decreased almost 23% year over year due to the decrease in collaborative arrange ...

Financial Data and Key Metrics Changes - For the full year 2024, the company achieved $916 million in net sales, meeting its financial guidance [14] - GAAP net income for 2024 was $1.8 million, with adjusted EBITDA of $100.6 million [28] - Total revenue for 2024 was $351.4 million, with cash and cash equivalents at $88.6 million at year-end [27][28] Business Line Data and Key Metrics Changes - LINZESS saw a 12% increase in prescription demand growth in Q4 2024 compared to Q4 2023, and 11% growth year-over-year for 2024 [13] - New-to-brand volume growth for LINZESS was 11% in Q4 2024 and 14% for the full year, marking eight consecutive quarters of double-digit growth [13] - Collaborative arrangements revenue was $88.4 million in Q4 2024 and $340.4 million for the full year [26] Market Data and Key Metrics Changes - The company is experiencing stabilization in Medicare utilization, which was a headwind in 2024, particularly in the second half of the year [14] - The market for short bowel syndrome is characterized by a smaller prescriber base, primarily located in specialized centers [11] Company Strategy and Development Direction - The company is focused on advancing apraglutide, aiming for it to become a blockbuster therapy for short bowel syndrome [7][9] - A rolling submission of the NDA for apraglutide has been initiated, with completion expected in Q3 2025 [9][19] - The company plans to implement a robust patient support service model for apraglutide, ensuring seamless care from prescription to treatment [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for LINZESS, despite anticipated pricing headwinds due to Medicare Part D redesign [14][30] - The company is focused on generating sustained profits and cash flows to support the advancement of apraglutide and repay debt [29][31] - Management is optimistic about the clinical evidence supporting apraglutide's potential to change treatment paradigms for short bowel syndrome [32] Other Important Information - The company reduced its total debt balance by approximately $115 million over the past 12 months [29] - The company has access to roughly $254 million in liquidity, including cash and undrawn revolver capacity [29] Q&A Session Summary Question: Confidence in initial learnings from virtual-based marketing and volume growth - Management indicated strong marketing support for LINZESS, with positive ROI from consumer advertising driving growth [37][40] Question: Cost savings recognition and R&D spending - Full impact of cost savings will be seen in Q2 2025, with R&D spending expected to remain stable in 2025 and potentially decrease in 2026 [44][45] Question: Confidence in maintaining compliance on debt covenants - Management expressed high confidence in maintaining covenant compliance throughout 2025 [50][51] Question: Patient characteristics achieving enteral autonomy with apraglutide - Patients achieving enteral autonomy include both stoma and CIC patients, with a significant number maintaining this status [56][59] Question: Timing of Medicare Part D redesign impact on LINZESS revenues - Management believes the impact will be more pronounced in the second half of 2025, but guidance accounts for this redesign [62][64] Question: Launch expenses for apraglutide and 2026 convertible notes - Launch expenses for apraglutide will ramp up as the launch date approaches, with a focus on strengthening the balance sheet to manage existing debt [68][70]

Ironwood Pharmaceuticals (IRWD) Q4 2024 Earnings Call March 31, 2025 12:02 PM ET Company Participants Greg Martini - CFOThomas McCourt - CEOMichael Shetzline - SVP, Chief Medical Officer and Head of Research & DevelopmentJason Butler - Managing Director & Biotechnology Equity ResearchKatherine Wang - Equity AssociateMatthew Cowper - Vice President - Equity Research Conference Call Participants Chase Knickerbocker - Senior Equity Research Analyst - HealthcareDavid Amsellem - Sr. Research Analyst Operator My ...

Ironwood Pharmaceuticals (IRWD) came out with quarterly earnings of $0.02 per share, missing the Zacks Consensus Estimate of $0.10 per share. This compares to break-even earnings per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -80%. A quarter ago, it was expected that this drugmaker would post earnings of $0.09 per share when it actually produced earnings of $0.02, delivering a surprise of -77.78%.Over the last four quarters, ...

Exhibit 99.1 FOR IMMEDIATE RELEASE Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Results; Achieves 2024 Financial Guidance – 2024 Ironwood revenue of $351 million, GAAP net income of $2 million and adjusted EBITDA of $101 million – BOSTON, Mass., February 27, 2025 — 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 ...

Core Viewpoint - Ironwood Pharmaceuticals has initiated a rolling new drug application for apraglutide to treat short bowel syndrome, while also undergoing significant corporate restructuring, including a workforce reduction of nearly 50% [1][2][7]. Group 1: Drug Development and NDA Submission - The rolling NDA submission for apraglutide is aimed at treating short bowel syndrome patients dependent on parenteral support, with completion expected in Q3 2025 [1]. - Ironwood acquired the rights to apraglutide through the acquisition of VectivBio in June 2023, and the drug has shown promising results in phase III studies [3]. - Data from the STARS Extend study indicated that longer exposure to apraglutide led to an increased number of patients achieving enteral autonomy, which is a key goal for SBS patients [4]. Group 2: Corporate Restructuring - The company plans to reduce its workforce by almost 50%, primarily affecting the field force, and will close the phase II exploratory study STARGAZE [2][7]. - Anticipated restructuring charges are estimated to be around $20-$25 million, primarily incurred in the first half of 2025 [7]. - The strategic reorganization is expected to yield annual operating expense savings of approximately $55-$60 million [8]. Group 3: Financial Guidance and Market Performance - Ironwood expects total revenues in the range of $260-$290 million for 2025, which is below the Zacks Consensus Estimate of $329.7 million [9]. - U.S. sales of Linzess are projected to be between $800-$850 million, and the company anticipates delivering adjusted EBITDA of over $85 million in 2024 [9]. - Following the announcements, Ironwood's shares fell by 11.6% and have decreased by 73.8% over the past year, contrasting with a 5.8% decline in the industry [2].

The Biden administration on Friday unveiled the next 15 prescription drugs that will be subject to price negotiations between manufacturers and Medicare, kicking off the second phase of a landmark process that aims to make costly medications more affordable for seniors. Topping the list are Novo Nordisk's blockbuster diabetes injection Ozempic, weight loss shot Wegovy and diabetes pill Rybelsus, which are considered one product in the talks since they all share the same active ingredient: semaglutide. Those ...