Rhythm Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net product revenue from global sales of IMCIVREE was $92.1 million for the third quarter of 2026, an increase of 29% sequentially from the second quarter of 2026 and a 79% increase from $51.3 million in the third quarter of 2025.
• U.S. revenue was $67.5 million (73% of product revenue), up $16.5 million or 32% sequentially, driven by increased patient demand for acquired HO and growth in Bardet-Biedl syndrome (BBS).
• Ex-U.S. revenue was $24.7 million (27% of product revenue), up $4.4 million or 22% sequentially.
• Year-to-date revenue for the nine months ended September 30, 2026, was $223.5 million, compared to $137.5 million in the same period of 2025.
• Research and development (R&D) expenses were $52.5 million for the quarter, up from $46.0 million in the prior year quarter, primarily due to increased CMC, clinical trial, and personnel costs.
• Selling, general, and administrative (SG&A) expenses were $66.8 million for the quarter, up from $52.4 million in the prior year quarter, driven by increased personnel costs and stock-based compensation.
• Net loss attributable to common stockholders was $(42.4) million, or $(0.61) per share, compared to $(54.3) million, or $(0.82) per share, in the third quarter of 2025.
• Cash, cash equivalents, and short-term investments totaled approximately $320.9 million as of September 30, 2026, down from $388.9 million as of December 31, 2025.
• Other expense, net, was $(1.5) million for the quarter, compared to $(0.1) million in the prior year quarter, due to decreased interest income.

Guidance and Future Outlook:

• For the year ending December 31, 2026, the company anticipates Non-GAAP Operating Expenses between $360 million and $380 million.
• GAAP R&D expenses are expected to be approximately $165 million to $175 million for the full year 2026.
• GAAP SG&A expenses are expected to be approximately $195 million to $205 million for the full year 2026.
• The company expects its cash position as of September 30, 2026, will be sufficient to fund planned operations for at least 24 months.
• Anticipated milestones include initiating a pivotal Phase 3 trial for bivamelagon in acquired HO by year-end 2026 and beginning country-level launches of IMCIVREE in Europe (starting with Germany) in 2027.

Business Segments and Product Lines:

• IMCIVREE (setmelanotide) commercial launch in Japan for acquired HO commenced on October 13, 2026.
• More than 700 patient start forms for IMCIVREE for acquired HO have been received from over 500 prescribers in the U.S. as of September 30, 2026.
• The number of patients on reimbursed therapy globally increased by 20% sequentially in the third quarter of 2026.
• Bivamelagon is advancing into pivotal development for Prader-Willi syndrome (PWS) and acquired HO.
• RM-718 enrollment in a Phase 1/2, Part D trial for PWS is expected to be completed in the second half of 2026.
• Health Canada approved IMCIVREE for weight management in adult and pediatric patients aged 4 and older with acquired HO on September 22, 2026.
• Five presentations regarding IMCIVREE were accepted for ObesityWeek® 2026, covering diagnostic criteria, patient-reported outcomes, and Phase 3 trial results.

Market and Competitive Landscape:

• The U.S. launch momentum for IMCIVREE in acquired HO is described as strong, reinforcing the significant unmet need in the disease.
• Japan is identified as a market with the potential to become the company's second largest.
• The company is expanding international operations, including launches in the UK and Europe.

Risks and Challenges:

• The press release notes forward-looking statements regarding clinical trial enrollment, regulatory approvals, and commercial growth which are subject to risks and uncertainties.
• Specific risks mentioned include the design and outcome of clinical trials, competition, unfavorable pricing regulations, third-party reimbursement practices, and healthcare reform initiatives.
• Risks also include the ability to successfully commercialize setmelanotide, liquidity and expense management, and the ability to retain key employees.

Management Commentary and Tone:

• David Meeker, M.D., Chairman, CEO, and President, stated that the company continues to make strong progress in bringing IMCIVREE to patients with acquired HO, highlighted by continued commercial momentum in the U.S.
• Management expressed confidence in the potential of bivamelagon across multiple indications following strong clinical results.
• Dr. Meeker noted that the restructured royalty agreement with LG Chem reflects a strong belief in the future potential of the portfolio.
• Management described a clear and compelling path to long-term growth and value creation with IMCIVREE as a global foundation, bivamelagon entering Phase 3, and further development planned for RM-718.

Other Key Points:

• Rhythm amended its exclusive license agreement with LG Chem for bivamelagon, agreeing to pay $350 million in fixed payments over four years to reduce the royalty rate from low-to-mid single digits to 1% on net product revenue.
• The company secured a five-year term loan facility providing access to up to $750 million, led by KKR's HealthCare Royalty in partnership with Blackstone Life Sciences.
• The company entered into an amended and restated Revenue Interest Financing Agreement with Health Care Royalty in connection with the term loan.
• Manher ("AJ") Joshi, M.D., was appointed as Chief Medical Officer on August 17, 2026.
• IMCIVREE received expanded Marketing Authorization in the United Kingdom for the treatment of obesity and control of hunger in patients with acquired HO due to hypothalamic injury or impairment.
• The company announced the presentation of six abstracts at the 64th Annual European Society for Paediatric Endocrinology (ESPE) Meeting.