Ironwood Pharmaceuticals (IRWD) Wells Fargo 21st Annual Healthcare Conference summary

Business performance and strategic changes

• Achieved a significant turnaround year with a $300-$350 million swing in net sales and projected 30% year-over-year growth.

• Improved cash flows enabled repayment of $200 million in convertible debt and ongoing deleveraging to below 1x EBITDA.

• LINZESS regained blockbuster status, surpassing $1 billion in sales, driven by improved net price and demand growth.

• List price reduction eliminated inflationary rebates, bringing more consistency to net pricing across channels.

• Raised full-year guidance mid-year due to continued net price benefits and higher demand expectations.

Market dynamics and access

• LINZESS maintains strong market access, with 100% Medicare coverage and leading position in IBS-C/CIC.

• Medicare Part D is the largest revenue segment, followed by commercial and Medicaid; pricing clarity expected through 2027.

• Demand growth is supported by an aging population and dissatisfaction with OTC therapies, with most new patients sourced from OTC.

• Expectation of mid-single-digit U.S. TRx volume growth for the full year.

• Market-leading access and payer collaboration are key to sustaining growth.

Apraglutide development and regulatory progress

• FDA requested a confirmatory trial for apraglutide due to dosing variability in the initial trial; new trial is shorter and smaller, with improved dosing instructions.

• Expanded U.S. trial sites to accelerate enrollment, aiming for NDA submission by 2029, with efforts to expedite timeline.

• Primary endpoint for the new trial is 24 weeks, leveraging data from previous trials and long-term extension studies.

• FDA now requires aggregate analysis of patient populations, simplifying trial design.

• Apraglutide's once-weekly dosing and favorable tolerability profile may offer advantages over daily GATTEX, with potential for higher patient retention and efficacy.