IRONWOOD PHARMACEUTICALS INC Q4 FY2023 earnings call

• Maximizing LINZESS: LINZESS had 10% y-o-y prescription demand growth in 2023, new-to-brand prescriptions up 15%, TRx share reached 46%, and FDA approval for pediatric functional constipation. - Advancing GI pipeline: Acquired VectivBio, Apraglutide Phase 3 STARS study on track for March readout, CNP-104 Phase 2 top-line data expected Q3 2024, IW-3300 Phase 2 study ongoing. - Delivering sustained profits/cash flow: Committed to capital allocation, expecting adjusted EBITDA >$150M in 2024.

LINZESS was a key segment. In 2023, LINZESS U.S. net sales were $1.73 billion, an increase of 7% year-over-year, driven by 10% prescription demand growth. LINZESS U.S. net sales in Q4 2023 were $274 million, up 5% from Q4 2022. Commercial margins for LINZESS were 73% for full year 2023 and 77% in Q4 2023. Ironwood revenues in full year 2023 were $443 million, with LINZESS U.S. collaboration revenues of $430 million.

• LINZESS U.S. net sales growth in low single digits, driven by high single-digit prescription demand growth offset by mid- to high single-digit price erosion from Medicaid AMP cap removal. - Ironwood revenue expected between $435 million and $455 million. - Adjusted EBITDA expected to be greater than $150 million.

• Risks associated with forward-looking statements, where actual results may differ. - Impact of Medicaid AMP cap removal on pricing and revenue. - Uncertainties in clinical trial outcomes for pipeline assets like Apraglutide and CNP-104.

Q: On CIC, thoughts on Apraglutide's PK translating to efficacy and hierarchical testing for secondary endpoints?

A: Mike Shetzline discussed PK/PD profile and hierarchical testing including total population 1 day off parenteral support, stoma subpopulation at 24 weeks, CIC specific at 48 weeks, and enteral autonomy at 48 weeks.

Q: Thoughts on Apraglutide pricing and ex-U.S. strategy?

A: Sravan Emany said pricing strategy not communicated yet, and ex-U.S. strategy is being considered strategically.

Q: On LINZESS 2024 net revenue guidance and pediatric exposure?

A: Sravan Emany discussed low single-digit growth with mid to high single-digit price erosion due to Medicaid changes, and Tom McCourt noted growth across all patient populations including pediatric, which is growing but still early.