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Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) has reiterated its full-year 2025 financial guidance for LINZESS U.S. net sales and total Ironwood revenue, while also raising its adjusted EBITDA forecast. The biotechnology company developing and commercializing life-changing therapies for gastrointestinal and rare diseases reported strong prescription demand growth for LINZESS in the first quarter of 2025, offset by anticipated pricing headwinds and a change in estimate of gross-to-net rebate reserves.
The company's updated 2025 guidance includes LINZESS U.S. net sales of $800-$850 million and total Ironwood revenue of $260-$290 million. Additionally, Ironwood has raised its adjusted EBITDA guidance to greater than $105 million for 2025, reflecting its strategic focus on the confirmatory Phase 3 trial for apraglutide and the reduction of certain commercial launch planning investments.
In the first quarter of 2025, LINZESS U.S. net sales were $138.5 million, a 46% decrease compared to the same period last year. This decrease is attributed to a change in AbbVie's estimate of gross-to-net rebate reserves, which is expected to impact the quarterly phasing of LINZESS U.S. net sales but not the full-year results. Ironwood and AbbVie share equally in U.S. brand collaboration profits.
Ironwood's chief executive officer, Tom McCourt, stated, "Today, we are reiterating our full-year 2025 LINZESS U.S. net sales and total Ironwood revenue guidance. In the first quarter of 2025, we saw continued strong prescription demand growth of 8% year-over-year, which was offset by anticipated pricing headwinds as well as a change in estimate of AbbVie gross-to-net rebate reserves, which was refined to reflect rebates owed for units dispensed in the first quarter of 2025. We do not expect first quarter LINZESS U.S. net sales results or this change in estimate to impact the full-year results." [NUMBER 1]
The company's financial guidance reflects Ironwood's strategic reorganization and the impact of the reduction to its commercial expenses and corresponding reimbursement from AbbVie. The adjusted EBITDA calculation excludes stock-based compensation, representing an update to the definition of adjusted EBITDA effective in the first quarter of 2025.
Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland. The company's LINZESS brand is the #1 prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), based on IQVIA data. LINZESS is a once-daily capsule that helps relieve abdominal pain, constipation, and overall abdominal symptoms associated with IBS-C and CIC.
References:
[1] https://www.businesswire.com/news/home/20250425289111/en/Ironwood-Pharmaceuticals-Reiterates-Full-Year-2025-LINZESS-U.S.-Net-Sales-Guidance-and-Raises-Adjusted-EBITDA-Guidance
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