RHYTHM PHARMACEUTICALS (RYTM) Company Report

Rhythm Pharmaceuticals reported product revenue of $57.3 million for Q4 2025, marking a 12% increase quarter-over-quarter, and $194.8 million for the full year 2025.
The company ended Q4 2025 with $388.9 million in cash, cash equivalents, and short-term investments.
Rhythm Pharmaceuticals provided 2026 Non-GAAP Operating Expenses guidance in the range of $385 million to $415 million.
A significant upcoming milestone is the March 20, 2026 PDUFA goal date for the sNDA for setmelanotide in acquired hypothalamic obesity.
The company is on track to initiate a pivotal Phase 3 trial evaluating oral bivamelagon in acquired hypothalamic obesity by the end of 2026.

2 days ago

Presentation

Rhythm Pharmaceuticals Reports Q4 and Full-Year 2025 Results, Prepares for HO Launch

RYTM

Earnings

Product Launch

Guidance Update

Rhythm Pharmaceuticals reported Q4 2025 revenue of $57.3 million, representing a 12% quarter-over-quarter increase, and full-year 2025 revenue of $194.8 million, an increase of approximately 50% from 2024.
The company is preparing for the Acquired Hypothalamic Obesity (HO) launch for IMCIVREE, pending regulatory approval with a PDUFA goal date of March 20, 2026.
For bivamelagon, the FDA confirmed readiness to move to Phase 3 for HO, requiring a 12-month double-blind, randomized controlled trial and a larger safety database, with a goal to initiate the Phase 3 HO study by year-end 2026.
Rhythm Pharmaceuticals ended 2025 with approximately $389 million in cash equivalents and short-term investments, which are expected to be sufficient to fund planned operations for at least 24 months.
The company provided 2026 non-GAAP operating expense guidance of $385 million to $415 million, including non-GAAP R&D expenses of $197 million-$213 million and non-GAAP SG&A expenses of $188 million-$202 million.

2 days ago

Transcript

Rhythm Pharmaceuticals Reports Strong Q4 and Full-Year 2025 Results, Provides 2026 Guidance, and Updates on Pipeline Milestones

RYTM

Earnings

Guidance Update

Product Launch

Rhythm Pharmaceuticals reported $57.3 million in IMCIVREE sales for Q4 2025 and $194.8 million for the full year 2025, representing a 12% sequential increase and approximately 50% year-over-year growth, respectively.
The company ended 2025 with approximately $389 million in cash, cash equivalents, and short-term investments, which are expected to fund planned operations for at least 24 months.
For 2026, Rhythm Pharmaceuticals anticipates non-GAAP operating expenses between $385 million and $415 million, an increase of approximately 35% over 2025, driven by investments in next-generation MC4R agonists, U.S. commercial operations for the Acquired Hypothalamic Obesity (HO) launch, and Japan operations.
Key upcoming milestones include the PDUFA date for Acquired HO in March 2026, top-line data from the Japanese HO cohort in March 2026, and full 6-month data from the PWS trial by mid-year 2026.
The FDA confirmed bivamelagon is ready for Phase 3, requiring a 12-month double-blind, randomized controlled trial with a larger safety database, with a goal to initiate the Phase 3 HO study by year-end 2026.

2 days ago

Transcript

Rhythm Pharmaceuticals Reports Q4 and Full-Year 2025 Revenue, Provides 2026 Guidance, and Advances Pipeline

RYTM

Earnings

Guidance Update

Product Launch

Rhythm Pharmaceuticals reported Q4 2025 revenue of $57.3 million and full-year 2025 revenue of $194.8 million, marking a 12% sequential increase and approximately 50% year-over-year growth, respectively.
The company is actively preparing for the Acquired Hypothalamic Obesity (HO) launch in the United States, with a PDUFA goal date of March 20, 2026, and anticipates a CHMP opinion in Q2 2026 and EU marketing authorization in the second half of 2026 for HO.
GAAP EPS for Q4 2025 was a net loss of $0.73 per basic and diluted share, and the company concluded 2025 with $389 million in cash equivalents and short-term investments, projected to fund operations for at least 24 months.
Rhythm Pharmaceuticals issued 2026 non-GAAP operating expense guidance of $385 million-$415 million, representing an approximate 35% increase over 2025, primarily driven by investments in next-generation MC4R agonists, US commercial operations for HO, and building operations in Japan.
Positive Phase 2 data for bivamelagon in HO demonstrated persistent BMI reductions and consistent safety, with plans to initiate a Phase 3 HO study by year-end 2026 following constructive feedback from the FDA.

2 days ago

Transcript

Rhythm Pharmaceuticals Reports Q4 and Full Year 2025 Financial Results and Provides 2026 Outlook

RYTM

Earnings

Guidance Update

Product Launch

Rhythm Pharmaceuticals reported Q4 2025 net product revenue from global sales of IMCIVREE of $57.3 million, contributing to a full-year 2025 revenue of $194.8 million, up from $130.1 million in full-year 2024.
The company posted a net loss attributable to common stockholders of $48.8 million, or $(0.73) per share, for Q4 2025, and $201.9 million, or $(3.11) per share, for the full year 2025.
As of December 31, 2025, cash, cash equivalents, and short-term investments were approximately $388.9 million, which is projected to fund operations for at least 24 months.
Key upcoming milestones include a PDUFA goal date of March 20, 2026, for the sNDA for setmelanotide in acquired hypothalamic obesity, and anticipated topline data announcements in March 2026 for the Japanese cohort of the setmelanotide Phase 3 trial in acquired HO and the Phase 3 EMANATE trial.
For the year ending December 31, 2026, Rhythm anticipates Non-GAAP Operating Expenses to be between $385 million and $415 million.

2 days ago

8-K

Rhythm Pharmaceuticals Reports Q4 and Full Year 2025 Results and Provides 2026 Outlook

RYTM

Earnings

Guidance Update

Product Launch

Rhythm Pharmaceuticals reported net product revenue from global sales of IMCIVREE of $57.3 million for the fourth quarter of 2025 and $194.8 million for the full year 2025.
The company ended 2025 with cash, cash equivalents, and short-term investments of $388.9 million as of December 31, 2025, which is expected to fund planned operations for at least 24 months.
Rhythm Pharmaceuticals anticipates a PDUFA goal date of March 20, 2026, for its sNDA for setmelanotide in acquired hypothalamic obesity (HO).
The company expects to report topline data in March 2026 from both the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired HO and the Phase 3 EMANATE trial.
For the year ending December 31, 2026, Rhythm anticipates Non-GAAP Operating Expenses between $385 million and $415 million.

2 days ago

Press Release

Rhythm Pharmaceuticals Discusses IMCIVREE Growth and Upcoming Milestones

RYTM

Product Launch

Revenue Acceleration/Inflection

New Projects/Investments

Rhythm Pharmaceuticals is awaiting a PDUFA date of March 20th for its therapy IMCIVREE (setmelanotide) for hypothalamic obesity (HO), which is considered the most significant indication for the company.
The company reported $57 million in sales last quarter, primarily from Bardet-Biedl syndrome (BBS), with 9% quarter-over-quarter growth for the bulk of last year.
Rhythm estimates upwards of 10,000 hypothalamic obesity patients in the U.S., presenting a significantly larger long-term sales opportunity compared to BBS, which has a $300 million peak sales opportunity in the U.S. alone.
The company maintains a strong financial position with $418 million in cash at the end of Q3, providing a cash runway of at least 24 months.
Positive interim Phase 2 data for setmelanotide in Prader-Willi syndrome (PWS) was reported, and a Phase 1 study for the weekly injectable RM-718 in PWS has commenced, with further data expected in the first half of the year.

Feb 11, 2026, 4:00 PM

Transcript

Rhythm Pharmaceuticals Provides Updates on IMCIVREE, Pipeline, and Financials at Biotech Conference

RYTM

Product Launch

New Projects/Investments

Guidance Update

Rhythm Pharmaceuticals anticipates a PDUFA date of March 20th for its hypothalamic obesity (HO) indication for IMCIVREE (setmelanotide), following a delay from December.
The company reported $57 million in sales last quarter, primarily from Bardet-Biedl syndrome (BBS), with an average 9% quarter-over-quarter growth for the bulk of last year, and projects a $300 million peak sales opportunity in the U.S. alone for BBS.
Rhythm has expanded its U.S. sales force to 42 salespeople and identified upwards of 10,000 potential HO patients in the U.S., with 2,000 suspected or diagnosed HO patients already identified.
Interim Phase 2 data for setmelanotide in Prader-Willi syndrome (PWS) is promising, with an 18-patient data readout expected in the first half of 2026.
Rhythm Pharmaceuticals exited Q3 (2025) with $418 million in cash, providing at least 24 months of cash runway.

Feb 11, 2026, 4:00 PM

Transcript

Rhythm Pharmaceuticals Discusses Upcoming PDUFA, Sales Growth, and Pipeline

RYTM

Product Launch

Revenue Acceleration/Inflection

New Projects/Investments

Rhythm Pharmaceuticals anticipates a PDUFA date of March 20, 2026, for hypothalamic obesity (HO), which is considered the most significant event for the company. The company has expanded its U.S. sales force to 42 and identified over 2,000 suspected HO patients in anticipation of approval.
The company reported $57 million in sales in the last quarter, primarily from Bardet-Biedl syndrome (BBS), with approximately 9% quarter-over-quarter growth for most of the previous year. The U.S. market for BBS alone is estimated to have a $300 million peak sales opportunity.
For HO, Rhythm Pharmaceuticals estimates upwards of 10,000 patients in the U.S., representing a significantly larger long-term sales opportunity than BBS.
Interim Phase II data for IMCIVREE in Prader-Willi syndrome (PWS) showed positive results, with two patients out six months doing well and several others showing improvements. Full Phase II data is expected in the first half of 2026, and a weekly injectable therapy, RM-718, is also in development for PWS.
Rhythm Pharmaceuticals ended Q3 with approximately $418 million in cash, providing at least 24 months of runway.

Feb 11, 2026, 4:00 PM

Transcript

Rhythm Pharmaceuticals Announces Preliminary Q4 and Full Year 2025 Net Product Revenues and Upcoming Milestones

RYTM

Earnings

Guidance Update

Product Launch

Rhythm Pharmaceuticals announced preliminary, unaudited net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an 11% increase over Q3 2025, and approximately $194 million for the full year of 2025, a 50% increase from FY 2024.
U.S. sales of IMCIVREE contributed approximately 68% of fourth quarter preliminary unaudited net product revenues and approximately 69% of full-year 2025 preliminary unaudited net product revenues.
The company has a March 20, 2026 PDUFA goal date for its sNDA for setmelanotide in acquired hypothalamic obesity, pending FDA approval for a U.S. launch.
Rhythm Pharmaceuticals is on track to report topline data in the first quarter of 2026 from the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired hypothalamic obesity and from the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases.

Jan 9, 2026, 2:06 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for RHYTHM PHARMACEUTICALS.

Q4 2025

Feb 26, 2026

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Q3 2025

Nov 4, 2025

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Q2 2025

Aug 5, 2025

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