IRONWOOD PHARMACEUTICALS INC Q4 FY2024 earnings call

Tom McCourt's Remarks - Focused on advancing apraglutide, with rolling NDA submission for apraglutide expected to be completed in Q3 2025. Restructured business to focus on apraglutide commercialization. LINZESS remains critical, with 12% Q4 2024 prescription demand growth and 11% full-year growth. ### Mike Shetzline's Remarks - Discussed apraglutide's clinical data from STARS Phase III and Extend studies, showing patients achieving enteral autonomy and reduction in parenteral support volume. ### Greg Martini's Remarks - Reviewed 2024 financial results, achieving full-year guidance with $351.4 million total revenue, $1.8 million GAAP net income, and $100.6 million adjusted EBITDA. Outlined 2025 guidance and focus on funding apraglutide advancement and debt repayment.

LINZESS contributed significantly to revenue. In the fourth quarter of 2024, LINZESS U.S. net sales were $223 million, and for the full year 2024, it was $916 million. Collaborative arrangements revenue was $88.4 million in Q4 2024 and $340.4 million for the full year. Apraglutide is the future focus but not yet a revenue contributor in terms of current financials.

2025 Guidance - U.S. LINZESS net sales expected between $800 million and $850 million with high single-digit prescription demand growth, offset by Medicare Part D pricing headwinds. ### Ironwood revenue expected between $260 million and $290 million. ### Adjusted EBITDA, excluding stock-based compensation, expected >$85 million, reflecting $55 million decrease in operating expenses mainly in SG&A due to reorganization. ### Focus on maintaining covenant compliance and funding apraglutide advancement.

Potential market uncertainties related to LINZESS demand and apraglutide regulatory approval. ### Regulatory risks associated with the NDA submission and approval process for apraglutide. ### Uncertainties around the impact of Medicare Part D redesign on LINZESS sales.

Q: Can you speak to confidence in high single-digit volume growth for LINZESS without in-person promotion?

A: Tom McCourt noted LINZESS has a solid marketing mix with consumer advertising, strong momentum, and broad payer access, confident in single-digit growth.

Q: When will cost savings from restructuring be fully recognized?

A: Greg Martini said first quarter won't see full impact, with full run rate in Q2.

Q: Confidence in maintaining revolver covenants?

A: Greg Martini stated high confidence in 2025 outlook and disciplined expense management to maintain covenants.

Q: Patient characteristics of those achieving enteral autonomy with apraglutide?

A: Greg Martini said apraglutide benefits from large Phase III program, seeing enteral autonomy on stoma and CIC patients, with numerical benefit across subpopulations.

Q: Timing of Medicare Part D redesign impact on LINZESS revenues?

A: Greg Martini said full year guidance accounts for impact, with better insights each quarter.

Q: Launch expenses for apraglutide and 2026 convert?

A: Greg Martini said commercial launch expenses not significant yet, with ramp-up closer to launch; 2026 convert evaluated in context of capital structure and focus on debt repayment.

Q: Further cost structure streamlining?

A: Greg Martini said will continue to evaluate alternatives to prioritize value-driving investments.