Ironwood Pharmaceuticals, Inc. (IRWD) reported adjusted earnings of 2 cents per share for the third quarter of 2024, missing the Zacks Consensus Estimate of 9 cents. The company had recorded adjusted earnings of 12 cents per share in the year-ago quarter.Total revenues in the third quarter were $91.6 million, which beat the Zacks Consensus Estimate of $89 million. However, the top line decreased almost 19.4% year over year due to the decrease in collaborative arrangements revenues related to its sole market ...

Financial Data and Key Metrics Changes - In Q3 2024, Ironwood reported US net sales of LINZESS at $226 million, reflecting a 19% year-over-year decline [11][18] - Ironwood's total revenue for Q3 was $92 million, also down 19% year-over-year [18] - GAAP net income for the quarter was $4 million, with adjusted EBITDA reported at $26 million [18][19] - The company generated $10 million in operating cash flow during the third quarter [10] Business Line Data and Key Metrics Changes - LINZESS experienced a 13% increase in prescription demand year-over-year, marking the seventh consecutive quarter of double-digit growth in new to brand prescriptions [6][11] - Despite strong volume growth, LINZESS faced pricing pressures primarily due to an increase in Medicaid prescriptions [6][11] Market Data and Key Metrics Changes - The company noted that LINZESS US net sales were down 19% year-over-year, with a year-to-date decline of 13% compared to the same period in 2023 [18] - The company is closely monitoring Medicaid utilization trends and legislative changes that may impact LINZESS [11][18] Company Strategy and Development Direction - Ironwood is focused on maximizing LINZESS profits and cash flow while advancing the apraglutide NDA submission, expected in Q1 2025 [10][19] - The company has decided not to pursue an exclusive license for CNP104 and has halted recruitment for the IW-3300 Phase 2 study to focus on high-value projects [9][10] - The strategic priority includes delivering sustained profits and cash flow, with an emphasis on managing pricing pressures for LINZESS [10][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing pricing headwinds for LINZESS but expressed confidence in the brand's market leadership and demand growth [10][20] - The company plans to provide further guidance on LINZESS demand and pricing expectations for 2025 early next year [11][19] Other Important Information - Ironwood amended its credit facility, providing $50 million in additional liquidity and extending maturity to December 2028 [18] - The company ended Q3 with $88 million in cash and cash equivalents, indicating a strong capital position to support future initiatives [18] Q&A Session Summary Question: Commercial margin for LINZESS and impact of Part D redesign in 2025 - Management acknowledged pricing headwinds in 2025 and indicated that guidance for that year will be provided early next year, while expressing satisfaction with current commercial margins [24][25] Question: Potential for renegotiation with payers as LINZESS approaches the end of its commercial life - Management is critically evaluating how to increase profits and cash flow, including exploring new contracting strategies and optimizing spending [28][30] Question: Drivers of demand growth and promotional strategies - Management emphasized the importance of growing the market and capturing share, while also focusing on efficient demand generation and lifecycle management opportunities [32][33] Question: Commercial readiness for apraglutide - Management highlighted ongoing preparations for market readiness, including disease awareness programs and building core capabilities for patient support [35][36] Question: Expected increase in SG&A costs for apraglutide prelaunch - Management indicated that guidance for 2025 will be provided next year, noting existing commercial infrastructure will support the launch [43][44] Question: Sales force strategy for apraglutide - Management expressed confidence in integrating apraglutide into the existing sales force, leveraging their experience in gastroenterology [46][47]

Ironwood Pharmaceuticals (IRWD) came out with quarterly earnings of $0.02 per share, missing the Zacks Consensus Estimate of $0.09 per share. This compares to earnings of $0.12 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -77.78%. A quarter ago, it was expected that this drugmaker would post earnings of $0.17 per share when it actually produced break-even earnings, delivering a surprise of -100%.Over the last four quarters, ...

Ironwood Pharmaceuticals, Inc. (IRWD) reported break-even earnings for the second quarter of 2024 compared with the Zacks Consensus Estimate of earnings of 17 cents per share. The company had recorded adjusted earnings of 31 cents per share in the year-ago quarter. Total revenues in the second quarter were $94.4 million, which also missed the Zacks Consensus Estimate of $104 million. The top line decreased almost 12.1% year over year due to the decrease in collaborative arrangements revenues related to the ...

1 Ironwood Pharmaceuticals Q2 2024 Investor Update August 8, 2024 | --- | --- | |--------------|-------| | | | | | | | | | | | | | | | | | | | | | | Introduction | | | | | | Matt Roache | | | | | | | | | | | | | | | | | | | 2 | Safe Harbor Statement 3 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about our ability to ...

Ironwood Pharmaceuticals (IRWD) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of $0.17. This compares to earnings of $0.31 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -100%. A quarter ago, it was expected that this drugmaker would post earnings of $0.18 per share when it actually produced a loss of $0.02, delivering a surprise of -111.11%. Over the last four quarters, the company has ...

Ironwood Pharmaceuticals, Inc. (IRWD) reported an adjusted loss of 2 cents per share for first-quarter 2024 in contrast to the Zacks Consensus Estimate of earnings of 18 cents per share. The company had recorded adjusted earnings of 25 cents per share in the year-ago quarter.Total revenues in the reported quarter were $74.9 million, which significantly missed the Zacks Consensus Estimate of $103 million. The top line decreased almost 28% year over year due to a $30.0 million gross-to-net change in estimate ...

Financial Data and Key Metrics Changes - In Q1 2024, Ironwood reported total revenue of approximately $75 million, a decrease of 28% year-over-year, primarily due to a $30 million reduction in collaborative arrangements revenue [9][18] - LINZESS U.S. net sales were reported at $257 million, reflecting a 3% year-over-year increase, with a commercial margin of 71% compared to 73% in Q1 2023 [99][85] - The company expects LINZESS U.S. net sales to decline in the mid-single digits for the full year 2024, with total revenue guidance set between $405 million and $425 million and adjusted EBITDA greater than $120 million [85][88] Business Line Data and Key Metrics Changes - LINZESS maintained strong demand momentum with a 10% year-over-year increase in prescription volume and an 18% increase in new-to-brand prescriptions, marking the 12th year on the market [3][17] - The company is focused on the commercialization of apraglutide, which has shown positive Phase III results for treating short bowel syndrome, with plans for a potential launch in 2025 [4][12] Market Data and Key Metrics Changes - The estimated addressable market for apraglutide includes approximately 17,000 adult patients in the U.S. and Europe suffering from short bowel syndrome with intestinal failure, with many still untreated by GLP-2 therapies [94] - The company has a strong sales presence established in the offices of GI specialists across the U.S., with over 90 sales representatives targeting major GI practices [29] Company Strategy and Development Direction - The strategic priorities include maximizing LINZESS, advancing the GI pipeline, and delivering sustained profits and cash flow [39] - The company aims to leverage its expertise in commercialization to maximize the potential of apraglutide and drive impactful outcomes for patients [13][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for LINZESS and the potential for apraglutide to achieve $1 billion in peak net sales due to its differentiated profile and once-weekly dosing [40][105] - The company is optimistic about the upcoming data presentations at medical congresses, which are expected to enhance the clinical profile of apraglutide [15][103] Other Important Information - Ironwood generated approximately $45 million in cash flow from operations in Q1 2024 and ended the quarter with $122 million in cash and cash equivalents [108] - The company does not anticipate the need to access capital markets for additional funding to support the potential apraglutide launch [10] Q&A Session Summary Question: What is the current internal estimate on durability of treatment for apraglutide? - Management indicated that the Phase III data supports the once-weekly administration and that the goal for most patients is enteral autonomy [28] Question: Can you provide updates on the addressable market for apraglutide post ICD-10 codes implementation? - Management noted that over 7,000 patients have been identified through ICD-10 codes, reinforcing their estimates of the patient population [120] Question: What are the expectations for the upcoming data at DDW? - Management confirmed that they plan to present data supporting the efficacy of apraglutide in both stoma and colon-in-continuity patient populations [36][72] Question: Can you elaborate on the gross-to-net adjustment and its impact? - The adjustment was primarily due to differences in government and contractual rebates, leading to a $60 million change in LINZESS U.S. net sales estimates [44][50] Question: What are the next steps for the apraglutide NDA submission? - Management emphasized that the submission is a top priority and that they are working diligently to prepare the necessary data for the filing [138]

16 20 month Long-Term Safety and Durability 42 patients with PBC Randomized, Double-blinded, placebo-controlled, parallel assignment Doses: Placebo, CNP-104 4mg/kg, CNP-104 8mg/kg IV Infusion on Days 1 and 8 10 | --- | --- | --- | |--------------------------------------------------------------------------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Sravan Emany Commercial Update, Q1 2024 Financial Highlights and Revised FY 2024 Guidance | | | | | | | ...

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 March 31, 2024 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) (State or other j ...