Linzess (linaclotide)
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IRWD Q4 Earnings and Revenues Fall Shy of Estimates, Stock Tanks
ZACKS· 2026-02-26 16:41
Key Takeaways IRWD posted Q4 loss and revenue miss, with sales down 47% and shares sliding 11%.Ironwood's Linzess profit share declined 49% as U.S. net sales dropped 27% Y/Y in Q4 2025.IRWD reaffirmed 2026 revenue outlook of $450M-$475M and continues to see EBITDA above $300M.Ironwood Pharmaceuticals (IRWD) reported an adjusted loss of 1 cent per share for the fourth quarter of 2025, against the Zacks Consensus Estimate of earnings of 2 cents. The company had reported adjusted earnings of 1 cent per share i ...
IRWD Rises 307% in 6 Months: Is This an Indication to Buy the Stock?
ZACKS· 2026-02-12 16:35
Core Insights - Ironwood Pharmaceuticals (IRWD) shares have surged 307.3% over the past six months, significantly outperforming the industry, sector, and S&P 500 Index, which saw a decline of 1.7% during the same period [1][8]. Company Performance - The primary driver for the stock's rise is the increasing demand for Linzess (linaclotide), Ironwood's sole marketed product, which is approved for treating irritable bowel syndrome with constipation (IBS-C) and functional constipation in children [4][10]. - Ironwood's revenue guidance for 2026 is optimistic, projecting total revenues of $450-$475 million, representing a 54% year-over-year increase at the midpoint, with adjusted EBITDA expected to exceed $300 million [8][11]. Revenue Generation - Ironwood collaborates with AbbVie (ABBV) for the marketing of Linzess in the U.S., sharing profits and losses equally. In the first nine months of 2025, Ironwood's share of net profit from Linzess sales was $244.1 million, with expectations for continued growth in 2026 [6][7]. - The company also has partnerships with Astellas Pharma and AstraZeneca for Linzess in Japan and China, respectively, generating steady royalty revenues based on net sales in those markets [9]. Market Strategy - Despite a reduction in Linzess' list price effective January 1, 2026, management anticipates an increase in net sales year-over-year due to reduced mandatory government rebates, which should enhance net revenues [12]. - Ironwood is focusing on label expansion studies for Linzess to support long-term growth [12]. Pipeline Development - Ironwood is advancing apraglutide, a next-generation GLP-2 analog, toward a phase III study in the first half of 2026, targeting short bowel syndrome with intestinal failure [13][14]. - The company acquired the rights to develop apraglutide following the acquisition of VectivBio in June 2023 [14]. Valuation Metrics - Ironwood is currently trading at a price-to-sales (P/S) ratio of 2.33, slightly above the industry average of 2.31, but below its five-year mean of 4.06 [15]. - The Zacks Consensus Estimate for 2026 earnings per share (EPS) has increased from 47 cents to 76 cents over the past 30 days, indicating a positive outlook from analysts [16]. Investment Outlook - The company is viewed positively, with recommendations for prospective investors to consider adding IRWD stock to their portfolios for potential gains in both the short and long term [17][18].
Does Ironwood's Bullish 2026 View Signal Greater Linzess Adoption?
ZACKS· 2026-02-05 14:51
Core Viewpoint - Ironwood Pharmaceuticals is experiencing increased demand for its primary product, Linzess, which is marketed in collaboration with AbbVie, indicating a positive outlook for the company's revenue growth in the coming years [1][5]. Group 1: Product and Market Performance - Linzess is approved for treating irritable bowel syndrome with constipation (IBS-C) in adults and children aged seven and above, as well as functional constipation in children aged six to 17 [2]. - Ironwood has partnerships with Astellas Pharma and AstraZeneca for Linzess' development in Japan and China, respectively, generating royalty revenue from these collaborations [3]. - The company's revenue primarily comes from its collaboration with AbbVie for Linzess in the U.S., where profits and losses are shared equally [4]. Group 2: Financial Outlook - Ironwood's share of net profit from Linzess sales in the U.S. was $244.1 million in the first nine months of 2025, with expectations for significant sales growth in 2026 [5][10]. - The company anticipates total revenues of $450 million to $475 million in 2026, representing a 54% year-over-year increase at the midpoint compared to 2025 [7]. - An adjusted EBITDA of over $300 million is expected in 2026, reflecting effective cost management [7]. Group 3: Stock Performance and Valuation - Ironwood's stock has surged 457.2% over the past six months, outperforming the industry and the S&P 500 [9]. - The company is trading at a price-to-sales (P/S) ratio of 2.35, which is higher than the industry average of 2.28, but below its five-year mean of 4.08 [11]. Group 4: Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share (EPS) remains stable at 16 cents, while estimates for 2026 have increased from 47 cents to 76 cents [13].
Ironwood Stock Rises 27% on Upbeat Revenue Guidance for 2026
ZACKS· 2026-01-05 16:31
Core Insights - Ironwood Pharmaceuticals (IRWD) shares increased by 26.7% on January 2 due to positive revenue guidance for 2026 [1][6] - The company maintained its revenue guidance for the full year 2025, initially provided in November 2025 [1] Revenue Guidance - Ironwood expects total revenues of $450 million to $475 million in 2026, reflecting a 54% year-over-year increase at the midpoint compared to 2025 [3] - The company anticipates adjusted EBITDA of more than $300 million in 2026, indicating effective cost management [3] Product Information - Ironwood's primary product, Linzess (linaclotide), is approved for treating irritable bowel syndrome with constipation (IBS-C) and functional constipation in children and adolescents [2] - In the past six months, Ironwood's shares surged by 498.9%, significantly outperforming the industry average increase of 6% [2] Pricing Strategy - Effective January 1, 2026, Linzess' list price will be reduced to enhance patient access, with expectations for net sales to increase year over year due to the removal of inflation-related statutory rebates [4] Pipeline Developments - Ironwood is developing apraglutide, a next-generation GLP-2 analog, for treating short bowel syndrome with intestinal failure [7] - The company plans to initiate a confirmatory phase III study on apraglutide in the first half of 2026 after aligning with the FDA on the study design [8] Financial Position - Ironwood expects revenues of $290 million to $310 million for 2025, with an adjusted EBITDA of over $135 million [9] - The company ended the fourth quarter of 2025 with more than $200 million in cash and cash equivalents [9] Market Position - Ironwood currently holds a Zacks Rank 1 (Strong Buy), indicating strong market confidence [10] - Other top-ranked biotech stocks include CorMedix (CRMD) and ANI Pharmaceuticals (ANIP), both also holding a Zacks Rank 1 [10]
IRWD Beats on Q3 Earnings & Revenues, Raises 2025 View, Stock Soars
ZACKS· 2025-11-11 16:01
Core Insights - Ironwood Pharmaceuticals (IRWD) reported adjusted earnings of 24 cents per share for Q3 2025, significantly surpassing the Zacks Consensus Estimate of 9 cents and up from 2 cents per share in the same quarter last year [1][6] - Total revenues for Q3 were $122.1 million, exceeding the Zacks Consensus Estimate of $68 million, representing a year-over-year increase of approximately 33.3% [1][6] Financial Performance - Linzess, Ironwood's sole marketed product, generated net sales of $314.9 million in the U.S., a 40% increase year-over-year, driven by improved net pricing and strong demand growth [3] - Total prescription demand for Linzess rose by 12% year-over-year [3] - Ironwood's share of net profit from Linzess sales in the U.S. amounted to $119.6 million, reflecting a 35% year-over-year increase [4] - The company recorded adjusted EBITDA of $81.8 million in Q3, showing a significant year-over-year increase [9] Guidance and Outlook - Ironwood raised its 2025 revenue guidance to a range of $290-$310 million, up from the previous guidance of $260-$290 million [10] - U.S. sales of Linzess are now expected to be between $860-$890 million, compared to the earlier projection of $800-$850 million [10] - The adjusted EBITDA forecast for 2025 has been increased to over $135 million, up from the previous expectation of more than $105 million [11] Product Developments - The FDA approved Linzess for the treatment of irritable bowel syndrome with constipation (IBS-C) in patients aged seven years and older, making it the first and only drug approved for this indication in the specified age group [12] - Ironwood is developing apraglutide, a next-generation GLP-2 analog, for treating patients with short bowel syndrome who are dependent on parenteral support [13][14] - The company plans to initiate a confirmatory phase III study for apraglutide in the first half of 2026, pending alignment with the FDA [14] Partnerships - Ironwood has agreements with Astellas Pharma and AstraZeneca for the development and commercialization of Linzess in Japan and China, respectively, with both companies required to pay royalties on net revenues [7]
IRWD Stock Rises as Q2 Earnings & Revenues Trump Estimates
ZACKS· 2025-08-08 15:41
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]
IRWD Stock Down 15% as Q1 Earnings & Revenues Miss Estimates
ZACKS· 2025-05-08 14:55
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]