Financial Performance - Ironwood Pharmaceuticals reported an adjusted loss of 14 cents per share for Q1 2025, wider than the Zacks Consensus Estimate of a loss of 5 cents, compared to an adjusted loss of 2 cents per share in the same quarter last year [1] - Total revenues for Q1 2025 were $41.1 million, missing the Zacks Consensus Estimate of $59 million, and representing a year-over-year decrease of approximately 45.1% [1] - The company's share price fell by 14.6% on May 7 due to the disappointing Q1 results [1] Product Performance - Ironwood's sole marketed product, Linzess, generated net sales of $138.5 million in the U.S., down 46% year-over-year, with prescription demand growth offset by price erosion from Medicare Part D redesign [3] - Total prescription demand for Linzess increased by 8% year-over-year [3] - Ironwood's share of net profit from Linzess sales in the U.S. was $38.8 million, also a decrease of 46% year-over-year [4] Revenue from Partnerships - Ironwood has agreements with Astellas Pharma and AstraZeneca for the development and commercialization of Linzess in Japan and China, respectively [4] - The company recorded $2.3 million in royalties and other revenues in Q1 2025, down 28.1% from the prior-year quarter [5] Cost and Expenses - Total costs and expenses in Q1 2025 were $70.3 million, an increase of 10% from the previous year [7] - Ironwood recorded a negative adjusted EBITDA of $4.7 million in Q1 2025, compared to an adjusted EBITDA of $21.1 million in the same quarter last year [7] Cash Position - As of March 31, 2025, Ironwood had cash and cash equivalents of $108.5 million, up from $88.6 million as of December 31, 2024 [7] 2025 Guidance - The company reaffirmed its 2025 guidance, expecting total revenues in the range of $260-$290 million and U.S. sales of Linzess to be between $800-$850 million [8] - Ironwood anticipates delivering an adjusted EBITDA of more than $105 million in 2025 [8] Pipeline Updates - Ironwood initiated the rolling NDA submission for apraglutide, a next-generation GLP-2 analog, for treating short bowel syndrome in January 2025 [9] - A confirmatory phase III study will be required for apraglutide approval, which is expected to delay the NDA filing completion originally anticipated in Q3 2025 [10] - The phase III STARS study evaluated apraglutide for reducing parenteral support dependency in adult patients with short bowel syndrome [11] Market Position - Ironwood currently holds a Zacks Rank 3 (Hold) [12] - In contrast, ANI Pharmaceuticals, a better-ranked stock in the biotech sector, carries a Zacks Rank 2 (Buy) [12]

Summary of Ironwood Pharmaceuticals Conference Call Company Overview - **Company**: Ironwood Pharmaceuticals - **Focus**: Gastrointestinal (GI) diseases - **Key Product**: LINZESS, successfully commercialized for about a decade - **Pipeline Product**: Aproglutide, aimed at treating short bowel syndrome [1][3] Core Points and Arguments Financial Performance - **LINZESS Growth**: Continued high single-digit growth in its twelfth year, with a target to meet or exceed guidance [3][4] - **EBITDA Target Increase**: Raised from $85 million to $105 million [4] - **Net Sales Guidance**: Reiterated full-year expectation of $800 million to $850 million despite lower first-quarter sales due to seasonal dynamics [13][15] Product Insights - **LINZESS Demand Drivers**: - Large patient population still untreated (tens of millions) [8] - Best-in-class clinical profile and high treatment satisfaction [8] - Broad payer access and potential transition to over-the-counter (OTC) status [9][10] - **Aproglutide Development**: - Positioned as best-in-class GLP-2 for short bowel syndrome with strong efficacy and safety data [5][22] - FDA requested a conservative trial, but the company is optimistic about the market opportunity [5][22] Strategic Considerations - **Pricing Pressures**: Evaluating strategic options due to pricing pressures on LINZESS and delays with Aproglutide [6] - **Market Positioning**: Focus on maximizing shareholder value and improving stock performance [6][39] - **Debt Management**: Acknowledgment of debt management as a priority while exploring options to realize the potential of both LINZESS and Aproglutide [39][41] Regulatory and Market Dynamics - **Medicare Part D Impact**: Adjustments in revenue recognition due to Part D redesign accounted for in sales guidance [15] - **FDA Engagement**: Ongoing discussions with the FDA regarding OTC approval for LINZESS and confirmatory trials for Aproglutide [16][33] Additional Important Insights - **Marketing Strategy**: Shifted from personal promotion to consumer advertising, maintaining brand growth while reducing costs [11][12] - **Clinical Trial Insights**: Positive results from the phase three trial of Aproglutide, with a focus on patient retention and efficacy [30][31] - **Future Plans**: Plans to retool sales efforts and maintain relationships within the GI community as they prepare for Aproglutide's launch [45][46] This summary encapsulates the key points discussed during the conference call, highlighting Ironwood Pharmaceuticals' current status, strategic direction, and future opportunities in the GI market.

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]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 IRONWOOD PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 100 Summer Street, ...

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 ...