Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-34620 IRONWOOD PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (617) 621-7722 (Re ...

Core Insights - Ironwood Pharmaceuticals (IRWD) reported adjusted earnings of 14 cents per share for Q2 2025, surpassing the Zacks Consensus Estimate of a loss of 2 cents, compared to breakeven earnings in the same quarter last year [1][7] - Total revenues for Q2 were $85.2 million, exceeding the Zacks Consensus Estimate of $62 million, although this represents a year-over-year decrease of approximately 9.7% [1][7] - The company's sole marketed product, Linzess, generated net sales of $248 million in the U.S., reflecting a 17% year-over-year increase due to prescription demand growth [4][5] Financial Performance - Ironwood's share of net profit from Linzess sales in the U.S. totaled $85.7 million, a decrease of 6% year-over-year despite higher overall product sales [5][7] - Royalties and other revenues were negative $0.5 million in Q2, down from $3 million in the same quarter last year [8] - Total costs and expenses in Q2 were $39.9 million, down 42.5% from the previous year [8] - Adjusted EBITDA for Q2 was $50.1 million, marking an increase of around 37.3% year-over-year [9] Guidance and Future Outlook - Ironwood maintained its 2025 guidance, expecting total revenues between $260 million and $290 million, with U.S. sales of Linzess projected to be between $800 million and $850 million [10] - The company anticipates delivering an adjusted EBITDA of over $105 million in 2025 [10] Pipeline Developments - Ironwood is developing apraglutide for treating short bowel syndrome with intestinal failure, having initiated a rolling NDA submission to the FDA in January 2025 [11] - A confirmatory phase III study will be required for apraglutide approval, with plans to finalize the study design and align with the FDA in Q4 2025 [12][13] - The company acquired the rights to develop apraglutide following the acquisition of VectivBio in June 2023 [13]

Exhibit 99.1 FOR IMMEDIATE RELEASE Ironwood Pharmaceuticals Reports Second Quarter 2025 Results; Maintains Full Year 2025 Financial Guidance – LINZESS (Iinaclotide) U.S. net sales of $248 million in Q2 2025; EUTRx demand growth of 10% year-over-year – – Plans to align with FDA on confirmatory Phase 3 trial design in Q4 2025 – – Progressing previously announced strategic alternatives review to maximize shareholder value – BOSTON, Mass., August 7, 2025 — Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotec ...

Company Overview - Ironwood Pharmaceuticals (IRWD) shares have decreased by approximately 18.4% over the past month, underperforming the S&P 500 [1] - The most recent earnings report is crucial for understanding the catalysts affecting the stock [1] Earnings Estimates - Fresh estimates for Ironwood have remained flat over the past month, with the consensus estimate shifting by -180% [2] VGM Scores - Ironwood has a Growth Score of B, a Momentum Score of F, and a Value Score of A, placing it in the top quintile for value investment strategy [3] - The aggregate VGM Score for Ironwood is A, which is significant for investors not focused on a single strategy [3] Outlook - Ironwood holds a Zacks Rank of 3 (Hold), indicating an expectation of in-line returns in the upcoming months [4] Industry Performance - Ironwood is part of the Zacks Medical - Drugs industry, where competitor Zoetis (ZTS) has seen a gain of 4.3% over the past month [5] - Zoetis reported revenues of $2.22 billion for the last quarter, reflecting a year-over-year increase of 1.4%, with EPS rising from $1.38 to $1.48 [5] - For the current quarter, Zoetis is projected to post earnings of $1.61 per share, indicating a year-over-year change of +3.2% [6] - The Zacks Consensus Estimate for Zoetis has changed by +1% over the last 30 days, also holding a Zacks Rank of 3 (Hold) [6]

Acquisition and Collaboration - The Company acquired VectivBio Holding AG in June 2023 to advance apraglutide for short bowel syndrome patients[33]. - The Company has collaboration agreements with AbbVie and AstraZeneca for linaclotide, with shared development costs and profits[51]. - The Company’s collaboration with AbbVie for linaclotide includes a 50% share of net profits and losses from U.S. sales[55]. - The collaboration agreement with AstraZeneca includes tiered royalties starting in the mid-single-digit percent, increasing up to 20%, with potential milestone payments totaling up to $90 million[68]. Financial Performance - Collaborative arrangements revenue for the three months ended March 31, 2025, totaled $41.1 million, a decrease from $74.9 million in the same period of 2024[51]. - Collaborative arrangements revenue related to LINZESS sales in the U.S. decreased to $38,769,000 in Q1 2025 from $71,715,000 in Q1 2024, representing a decline of 46%[59]. - Total collaborative arrangements revenue for the same period was $39,394,000 in Q1 2025 compared to $72,455,000 in Q1 2024, a decrease of 45.5%[59]. - The Company recognized a $38.0 million reduction to collaboration revenue during the three months ended March 31, 2024, due to changes in estimates of sales reserves and allowances[58]. Expenses and Liabilities - The Company incurred $1.8 million in total research and development expenses under the linaclotide collaboration for North America during the three months ended March 31, 2025[54]. - The company incurred $3.1 million in selling, general and administrative costs for LINZESS sales in Q1 2025, down from $10.2 million in Q1 2024[59]. - The Company incurred $18.3 million in restructuring expenses during the three months ended March 31, 2025, primarily related to workforce reductions[131]. - Total accrued expenses and other current liabilities increased to $33,439,000 as of March 31, 2025, compared to $26,849,000 as of December 31, 2024[96]. Cash and Debt Management - As of March 31, 2025, the Company has cash and cash equivalents sufficient to meet projected operating needs for at least the next twelve months[34]. - The Company has long-term debt obligations, including convertible notes maturing on June 15, 2026[34]. - The estimated fair value of the 2026 Convertible Notes was $176,900,000 as of March 31, 2025, down from $186,600,000 as of December 31, 2024[89]. - The Company repaid the $200,000,000 aggregate principal amount of the 2024 Convertible Notes upon maturity in June 2024[99]. - The Revolving Credit Facility was increased from $500.0 million to $550.0 million in September 2024, with a maturity date extended to December 31, 2028[115]. - As of March 31, 2025, the outstanding principal balance on the revolving credit facility was $385.0 million, with total interest expense recognized of $7.149 million for the three months ended March 31, 2025[124]. Revenue and Royalty Income - Royalty revenue from Canada and Mexico combined was $0.6 million in Q1 2025, slightly down from $0.7 million in Q1 2024[60]. - The company recognized $0.8 million in royalty revenue from Europe and the Expanded Territory in Q1 2025, up from $0.7 million in Q1 2024[63]. - Under the license agreement with AbbVie, royalties based on sales volume in Europe are in the upper-teens percent, while royalties in the Expanded Territory are in the upper-single digits for the first five years[62]. - The company recognized $0.5 million in revenue related to development activities in Q1 2025, down from $0.7 million in Q1 2024[76]. Tax and Regulatory Compliance - The Company recorded an income tax expense of $1.1 million for the three months ended March 31, 2025, compared to $9.1 million for the same period in 2024[128]. - The Company adopted ASU 2023-09 on January 1, 2025, which improves transparency in income tax disclosures[43]. Asset Management - Total assets measured at fair value as of March 31, 2025, amounted to $75,083,000, with $53,563,000 in money market funds and $21,520,000 in commercial paper[87]. - The Company recorded a right-of-use asset of $10,600,000 and an operating lease liability of $14,900,000 as of March 31, 2025[94]. Interest and Currency Risks - The effective annual interest rate of the 2026 Convertible Notes was 1.9% as of March 31, 2025[109]. - The Company is exposed to a potential increase in annual interest expense of $2.6 million from a 10% change in the applicable interest rate on its $550.0 million Revolving Credit Facility[204]. - The fair value of the 2026 Convertible Notes is dependent on the price and volatility of the Company's Class A Common Stock, affecting the cash required at conversion or maturity[205]. - The company is exposed to foreign currency exchange rate risks due to international operations, with local currencies as functional currencies[207]. - The company does not currently hedge its foreign currency exchange rate risk, and fluctuations are not expected to materially impact results[207].

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)