Company Performance - Ironwood Pharmaceuticals reported a quarterly loss of $0.14 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.05, and compared to a loss of $0.02 per share a year ago, indicating an earnings surprise of -180% [1] - The company posted revenues of $41.14 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 21.83%, and down from $74.88 million in the same quarter last year [2] - Over the last four quarters, Ironwood has not surpassed consensus EPS estimates and has topped consensus revenue estimates only once [2] Stock Performance - Ironwood shares have declined approximately 79.1% since the beginning of the year, contrasting with the S&P 500's decline of -4.7% [3] - The current Zacks Rank for Ironwood is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.03 on revenues of $64.03 million, and for the current fiscal year, it is $0.23 on revenues of $267.76 million [7] - The trend of estimate revisions for Ironwood is mixed, and changes in these estimates could impact stock performance [6] Industry Context - The Medical - Drugs industry, to which Ironwood belongs, is currently in the top 26% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]

Core Viewpoint - Ironwood Pharmaceuticals (IRWD) is anticipated to report a year-over-year decline in earnings due to lower revenues for the quarter ended March 2025, with the consensus outlook indicating a significant impact on its near-term stock price [1][3]. Earnings Expectations - The consensus EPS estimate for Ironwood is a loss of $0.05 per share, reflecting a year-over-year change of -150% [3]. - Expected revenues are projected at $59.45 million, which is a decrease of 20.6% compared to the same quarter last year [3]. Estimate Revisions - Over the last 30 days, the consensus EPS estimate has been revised down by 42.86%, indicating a bearish sentiment among analysts regarding the company's earnings prospects [4]. - The Most Accurate Estimate for Ironwood is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -121.05% [10][11]. Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from the consensus estimate, with a strong predictive power for positive readings [6][7]. - Stocks with a positive Earnings ESP and a Zacks Rank of 1, 2, or 3 have historically produced a positive surprise nearly 70% of the time [8]. Historical Performance - Ironwood has not been able to beat consensus EPS estimates in any of the last four quarters, with a notable surprise of -80% in the last reported quarter [12][13]. Conclusion - Ironwood does not appear to be a compelling candidate for an earnings beat, and investors should consider other factors when making decisions regarding this stock ahead of its earnings release [16].

[Financial Performance and Guidance](index=1&type=section&id=Financial%20Performance%20and%20Guidance) [2025 Financial Guidance](index=1&type=section&id=2025%20Financial%20Guidance) 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](index=3&type=chunk) - 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](index=7&type=chunk) [Q1 2025 Performance Highlights](index=1&type=section&id=Q1%202025%20Performance%20Highlights) 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](index=2&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) - 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](index=3&type=chunk)[8](index=8&type=chunk) [Corporate and Product Information](index=3&type=section&id=Corporate%20and%20Product%20Information) [About Ironwood Pharmaceuticals](index=3&type=section&id=About%20Ironwood%20Pharmaceuticals) 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](index=9&type=chunk) - Ironwood is advancing **apraglutide**, a long-acting synthetic GLP-2 analog, for **short bowel syndrome**[9](index=9&type=chunk) - The company was founded in 1998 and is headquartered in Boston, Massachusetts, with an additional site in Basel, Switzerland[10](index=10&type=chunk) [About LINZESS (Linaclotide)](index=3&type=section&id=About%20LINZESS%20%28Linaclotide%29) 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](index=11&type=chunk) - It is the **first FDA-approved medicine** in the **GC-C agonist class**, which is distinct from laxatives[12](index=12&type=chunk) - 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](index=13&type=chunk) [LINZESS Important Safety Information](index=3&type=section&id=LINZESS%20Important%20Safety%20Information) 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](index=3&type=section&id=Indications%20and%20Usage) 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](index=14&type=chunk) - Indicated for **children and adolescents (6 to 17 years) with functional constipation (FC)**[14](index=14&type=chunk) [Warnings and Precautions](index=4&type=section&id=Warnings%20and%20Precautions) 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](index=15&type=chunk)[16](index=16&type=chunk) - The drug is also **contraindicated** in patients with known or suspected **mechanical gastrointestinal obstruction**[18](index=18&type=chunk) [Common Adverse Reactions](index=4&type=section&id=Common%20Adverse%20Reactions) 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](index=19&type=chunk) - In adult patients, other common adverse reactions (≥2% and greater than placebo) included **abdominal pain, flatulence, and abdominal distension**[19](index=19&type=chunk) [Disclosures](index=5&type=section&id=Disclosures) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) 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](index=21&type=chunk) - Highlights that **actual results may differ materially** due to risks such as clinical development outcomes, pricing and reimbursement policies, competition, and patent protection[21](index=21&type=chunk) - 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](index=21&type=chunk)

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, ...