Rhythm Pharmaceuticals Hits $194.8M in 2025 IMCIVREE Sales, Preps March HO PDUFA

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Rhythm Pharmaceuticals reported Q4 net product revenue of $57.3 million, up 12% sequentially, driving full-year IMCIVREE sales to $194.8 million—a 50% increase year-over-year—while US contributed $39.0 million and ex-US $18.3 million. The company prepares for a March 20 PDUFA decision on acquired hypothalamic obesity and expects Phase 3 Japan data in March.

1. Q4 Financial Performance

Rhythm recorded net IMCIVREE revenue of $57.3 million in Q4, up 12% sequentially, contributing to full-year sales of $194.8 million—a 50% increase versus the prior year. US sales accounted for $39.0 million (68%) while ex-US revenues reached $18.3 million, reflecting a one-time $3.2 million pricing adjustment in France from the previous quarter.

2. Inventory Build and Q1 Outlook

In Q4, vials shipped to specialty pharmacies exceeded patient dispensations by approximately 1.7 million units, increasing inventory days on hand to about 20 days from a normalized 10–15 days. Management warned this pull-forward could dampen first-quarter revenue, alongside typical payer plan renewals and patient transitions on and off the bridge program.

3. Acquired Hypothalamic Obesity and Pipeline

Rhythm is preparing for a March 20 PDUFA decision for acquired hypothalamic obesity, a neuroendocrine disease affecting an estimated 10,000 US patients. The company expanded its US sales force from 16 to 42, engaged providers managing over 2,000 diagnosed or suspected cases, and highlighted 40-week Phase 2 bivamelagon data showing mean BMI reductions of 10.8% (400 mg) and 14.3% (600 mg), with full 52-week results due mid-year.

4. International Expansion and Japan Phase 3

Ex-US operations grew to over 100 employees across 13 countries, with IMCIVREE available in more than 25 markets and eight new launches in 2025. The EMA review for HO is under CHMP consideration with an opinion expected in Q2 and EU authorization possible in H2 2026, while Phase 3 Japan top-line data is due in March, targeting a launch within the next 12 months.

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