Ironwood Q4: $351mln revenue, 11% LINZESS demand growth YoY, $101mln adj. EBITDA.

• Ironwood reports Q4 and FY24 results • Achieved 2024 financial guidance • Positive open-label extension study data • Increased patients on apraglutide achieving enteral autonomy • Initiated rolling NDA submission • LINZESS demand growth of 11% for FY24 • FY24 Ironwood revenue at $351 million • GAAP net income at $2 million • Adjusted EBITDA at $101 million

Ironwood Pharmaceuticals (IRWD) reported its fourth-quarter and full-year 2023 financial results on February 28, 2024, showcasing a robust performance and promising clinical developments [1]. The company achieved its 2024 financial guidance and reported revenue of $351 million for the year [1].

One of the most notable developments for Ironwood in Q4 2023 was the positive results from its Phase III STARS trial of once-weekly apraglutide for adult patients with Short Bowel Syndrome with Intestinal Failure (SBS-IF) [2]. The trial met its primary endpoint, with apraglutide reducing actual weekly parenteral support (PS) volume by an average of 27.3% compared to placebo at week 24 [2]. Additionally, patients treated with apraglutide experienced a clinically meaningful improvement, achieving at least one day off PS per week [2].

Apraglutide, a GLP-2 analog, has shown potential as a treatment for SBS-IF patients who are dependent on PS. The positive results from the STARS trial have led Ironwood to initiate rolling New Drug Application (NDA) submissions and other regulatory filings for apraglutide as a once-weekly treatment for adult patients with SBS who are dependent on PS [2].

Another significant development for Ironwood in Q4 2023 was the growth of LINZESS demand, with a year-over-year increase of 11% for FY2024 [1]. LINZESS, an approved treatment for irritable bowel syndrome with constipation (IBS-C), has been a key contributor to Ironwood's revenue growth.

Ironwood reported GAAP net income of $2 million and adjusted EBITDA of $101 million for FY2024 [1]. The company's financial performance demonstrates its continued progress in delivering innovative treatments for gastrointestinal disorders.

[1] Ironwood Pharmaceuticals. (2024, February 28). Ironwood Pharmaceuticals Reports Fourth-Quarter and Full-Year 2023 Results and Achieves 2023 Financial Guidance. Retrieved from https://investor.ironwoodpharma.com/press-releases/press-release-details/2024/Ironwood-Pharmaceuticals-Reports-Fourth-Quarter-and-Full-Year-2023-Results-Achieves-2023-Financial-Guidance/default.aspx
[2] Ironwood Pharmaceuticals. (2024, February 29). Ironwood Pharmaceuticals Announces Positive Topline Results from Global Phase III Trial of Once-Weekly Apraglutide in Adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF). Retrieved from https://investor.ironwoodpharma.com/press-releases/press-release-details/2024/Ironwood-Pharmaceuticals-Announces-Positive-Topline-Results-from-Global-Phase-III-Trial-of-Once-Weekly-Apraglutide-in-Adults-with-Short-Bowel-Syndrome-with-Intestinal-Failure-SBS-IF/default.aspx