Rhythm Pharmaceuticals Reports Q4 2025 Earnings, Beats Estimates, Sets March 2026 PDUFA Goal for Setmelanotide in Acquired Hypothalamic Obesity

RYTM
February 26, 2026

Rhythm Pharmaceuticals, Inc. reported fourth‑quarter and full‑year 2025 financial results on February 26, 2026, showing net product revenue of $57.3 million for Q4 and $194.8 million for the year, up 37% and 50% respectively from the same periods in 2024. The company’s earnings per share of $‑0.73 beat consensus estimates of $‑0.79, a $0.06 improvement driven by disciplined cost management that preserved margins despite a 4% increase in revenue.

Cash, cash equivalents and short‑term investments stood at $388.9 million as of December 31, 2025, an increase of $68.3 million from the $320.6 million reported a year earlier. Non‑GAAP operating expenses for 2025 were $295.5 million, reflecting a shift from $42.0 million in R&D to $57.5 million in SG&A in Q4, as the company ramps up commercial operations in preparation for the launch of setmelanotide in acquired hypothalamic obesity (HO). Management highlighted that the company’s gross profit margin remained strong at 89.4% over the last twelve months, with cost of goods sold at 8.5% of product revenue.

Rhythm confirmed a March 20, 2026 PDUFA goal date for the supplemental New Drug Application of setmelanotide in HO and announced that topline data from a Phase 3 Japanese cohort and the EMANATE trial will be reported in the same month. The company also reiterated its guidance for 2026, projecting non‑GAAP operating expenses of $385 million to $415 million, a range that signals continued investment in commercial expansion while maintaining a focus on cost discipline.

"Our strong financial performance in Q4 2025 is a testament to the effectiveness of our commercial strategy and the growing demand for IMCIVREE," said CEO David Meeker. He added, "We are prepared to bring IMCIVREE to patients with acquired HO in the United States, pending FDA approval," and noted that the company is advancing next‑generation MC4R pathway agonists to improve patients’ lives. CFO Hunter C. Smith cautioned that a $1.3 million negative inventory swing and an increase in inventory days on hand to roughly 20 days could dampen U.S. sales in the first quarter of 2026, reflecting a pull‑forward of revenue from the quarter of actual patient demand.

Investors responded positively to the earnings release, citing the earnings beat, robust revenue growth, and the upcoming regulatory milestones as key drivers of confidence in Rhythm’s near‑term commercial and clinical trajectory.

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