Rhythm Pharmaceuticals announced that it has secured product listing agreements in Ontario, Alberta, British Columbia, Saskatchewan, Nova Scotia, and the Federal Non‑Insured Health Benefits program, enabling public reimbursement for its rare‑obesity therapy IMCIVREE (setmelanotide) for patients with Bardet‑Biedl syndrome and obesity. The agreements cover adult and pediatric patients aged six and older who have clinically or genetically confirmed Bardet‑Biedl syndrome and obesity, removing a key barrier to access in Canada.
The new reimbursement agreements are a strategic win that expands Rhythm’s commercial footprint in the Canadian rare‑obesity market. By removing the cost barrier, the company is positioned to capture a larger share of patients who previously could not afford the drug, which is expected to translate into incremental sales. The move also aligns with Rhythm’s broader strategy to grow its presence in rare neuroendocrine diseases, reinforcing its competitive position against other rare‑disease therapies.
Rhythm’s Q3 2025 results provide context for the impact of the Canadian reimbursement. The company reported $51.3 million in revenue, a 6 % sequential increase from Q2 2025 and a 54.3 % year‑over‑year rise from $33.3 million in Q3 2024. U.S. sales accounted for 74 % of revenue, while international sales grew to $13.1 million. The Canadian reimbursement is expected to add to the international segment, potentially boosting future quarterly revenue and supporting the company’s guidance for 2025 operating expenses of $295–$315 million.
Management emphasized the significance of the agreements. CEO David Meeker said the reimbursement “removes a key barrier to access and positions Rhythm to capture a larger share of the Canadian rare‑obesity market.” General Manager Carol Stiff of Rhythm Canada added that the agreements “recognize the substantial burden of obesity associated with this rare disease” and that the company remains committed to equitable access for patients across the country.
The market reaction has been mixed. Oppenheimer downgraded Rhythm from “Outperform” to “Perform,” citing valuation concerns and the view that the anticipated hypothalamic obesity label expansion is already priced in. Other analysts, including H.C. Wainwright and Stifel, maintained positive ratings and raised price targets, reflecting confidence in the company’s revenue growth and the therapeutic potential of IMCIVREE. The mixed reaction underscores investors’ focus on valuation multiples while acknowledging the company’s strong commercial momentum.
Looking ahead, Rhythm is preparing for a U.S. launch of IMCIVREE for acquired hypothalamic obesity with a PDUFA date of December 20, 2025, and expects preliminary results from a Phase II Prader‑Willi syndrome trial by year‑end 2025. The company’s guidance for 2025 reflects confidence in continued growth, supported by the Canadian reimbursement and upcoming U.S. milestones.
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