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    RYTM
    Earnings call· Dec 2025(Q4 FY25)

    RHYTHM PHARMACEUTICALS Q4 FY25 earnings call RYTM

    Feb 26, 2026 Source

    Executive summary

    Rhythm Pharmaceuticals Q4 FY25 — Strong IMCIVREE Sales and Bivamelagon Phase 3 Progress

    Rhythm Pharmaceuticals delivered a strong Q4 FY25, driven by robust IMCIVREE sales growth and significant progress in its pipeline, particularly with Bivamelagon's Phase 2 data supporting a move to Phase 3. The company is actively preparing for the acquired hypothalamic obesity launch, while also managing increased operating expenses for future investments. The FDA's requirement for a longer Bivamelagon Phase 3 trial highlights the regulatory hurdles for new chemical entities, but management remains confident in its long-term growth strategy.

    Highlights

    5

    • Global IMCIVREE sales reached $57.3 million in Q4 FY25, a 12% sequential increase and 37% YoY increase, driven by a 10% increase in patients on reimbursed therapy.

    • Full-year 2025 IMCIVREE revenue increased approximately 50% to $194.8 million.

    • Bivamelagon Phase 2 data showed persistent mean BMI reductions of 10.8% (400mg cohort) and 14.3% (600mg cohort) at 40 weeks, with FDA confirming readiness for Phase 3.

    • Ended FY25 with $389 million in cash, cash equivalents, and short-term investments, sufficient to fund operations for at least 24 months.

    • Acquired HO launch preparations are on track, with engagement with HCPs caring for over 2,000 suspected patients and payer coverage expected within 3-9 months post-approval.

    Concerns

    4

    • Inventory days on hand at specialty pharmacy increased to approximately 20 days, potentially pulling forward $1.7 million in Q4 revenue from Q1 FY26.

    • FDA requires a full 12-month double-blind randomized controlled trial for Bivamelagon Phase 3, with a larger safety database (closer to 142 patients), rather than a shorter trial.

    • Non-GAAP operating expenses are anticipated to increase by approximately $104.5 million at the midpoint in 2026, a 35% increase over 2025, driven by Bivamelagon/RM-718 development, HO launch, and Japan operations.

    • PWS study has a minimal threshold of 5% BMI change for success, acknowledging it's a challenging disease with multiple genetic factors.

    Guidance & targets

    6
    CategoryTargetConfidence
    Full-year Non-GAAP Operating Expenses
    $385 million to $415 million
    high materiality
    High
    Full-year Non-GAAP R&D Expenses
    $197 million to $213 million
    medium materiality
    High
    Full-year Non-GAAP SG&A Expenses
    $188 million to $202 million
    medium materiality
    High
    IMCIVREE EU marketing authorization for HO
    H2 2026
    high materiality
    Medium
    Bivamelagon Phase 3 HO study initiation
    Year-end 2026
    high materiality
    Medium
    Cash runway
    at least 24 months
    high materiality
    High

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    IMCIVREE Global Sales
    Strong global sales driven by increased patient numbers on reimbursed therapy. Includes sales in over 25 countries outside the US.
    Patients on reimbursed therapy: increased by approximately 10% sequentially
    		$57.3 million37%12%—
    IMCIVREE US Sales
    Represented 68% of total product revenue. Growth driven by increases in product dispensed to patients.
    		$39 million—$2.1 million increase—
    IMCIVREE ex-US Sales
    Represented 32% of total product revenue. Sequential increase largely due to negative impact of a one-time $3.2 million charge in Q3 2025 related to France pricing agreement.
    		$18.3 million—$5.2 million increase (40%)—

    Operational metrics

    32
    Bivamelagon Phase 2 patient BMI loss
    14.5%
    14 weeks

    One 64-year-old male patient in the 600mg cohort lost 14.5% BMI at 14 weeks before discontinuing.

    Global IMCIVREE sales
    $51.3 millionbaseline for Q4 walk
    Q3 FY25

    Global sales in Q3 FY25, prior to the $57.3 million in Q4 FY25.

    US specialty pharmacy inventory variance
    $1.7 milliongreater than dispensed
    Q4 FY25

    Volume of vials shipped to specialty pharmacy was $1.7 million greater than vials dispensed to patients in Q4 2025.

    GAAP EPS component from accrued dividends
    $0.02
    Q4 FY25

    Included in the GAAP EPS net loss of $0.73 per share.

    GAAP operating expenses
    $362.3 million
    FY25

    Total GAAP operating expenses for the full year 2025.

    Stock-based compensation
    $66.8 million
    FY25

    Included in GAAP operating expenses for 2025.

    Gross cash proceeds from convertible preferred shares
    $150 million
    April 2024

    Raised through the issuance of convertible preferred shares.

    Full-year 2025 IMCIVREE revenue
    $194.8 millionup 50% from 2024
    FY25

    Total revenue from sales of IMCIVREE for the full year.

    US sales gross to net
    84.6%generally in line with previous quarters
    Q4 FY25

    Gross to net percentage for US sales.

    Cost of goods sold as % of product revenue
    8.5%down slightly
    Q4 FY25

    Primarily attributable to cost of materials and royalty payment on setmelanotide. Down slightly due to increase in finished goods inventory.

    R&D expenses
    $42 millionvs $41.2 million Q4 FY24; decreased $4 million sequentially from Q3 FY25
    Q4 FY25

    Decrease due to transition of area development managers to sales reps and decreased costs in Phase 3 HO trial and Phase 2 Bivamelagon trial.

    SG&A expenses
    $57.5 millionvs $38.1 million Q4 FY24; increased $5.1 million sequentially from Q3 FY25
    Q4 FY25

    Increase due to increased headcount costs and professional fees associated with anticipated HO launch and field force transfer.

    Weighted average common shares outstanding
    67 million
    Q4 FY25

    Weighted average common shares outstanding for the fourth quarter.

    GAAP EPS
    -$0.73
    Q4 FY25

    Net loss per basic and diluted share.

    Cash used in operations
    $25 millionvs $116 million FY25
    Q4 FY25

    Cash used in operations for the fourth quarter.

    Cash, cash equivalents and short-term investments
    $389 million
    end of FY25

    Total cash and investments at the end of 2025.

    Common share count
    68,285,039
    February 24, 2026

    Total common shares outstanding as of February 24, 2026.

    Preferred shares converted
    729,164
    since Q3 FY25 end

    Common stock converted from preferred shares since the end of Q3 FY25.

    Remaining potential common shares from preferred
    2,395,831
    as of Feb 24, 2026

    Potential common shares that could be converted from remaining preferred shares.

    Non-GAAP operating expenses
    $295.5 millionlower end of guided range
    FY25

    Non-GAAP operating expenses for the full year 2025.

    Non-GAAP operating expenses increase
    $104.5 million35% over 2025 (midpoint)
    FY26

    Anticipated increase in non-GAAP operating expenses for 2026.

    Specialty pharmacy inventory days on hand
    20 daysvs normalized 10-15 days
    Q4 FY25 end

    Inventory days on hand at the specialty pharmacy increased for the second consecutive quarter.

    Inventory swing
    -$1.3 million
    Q3 to Q4 FY25

    Net effect of vials shipped vs dispensed, representing a negative inventory swing from Q3 to Q4.

    One-time charge for France pricing agreement
    $3.2 million
    Q3 FY25

    Negative impact on ex-US revenue in Q3 2025 related to the final agreement on reimbursed price for IMCIVREE.

    Setmelanotide Phase 3 BMI decrease (non-GLP-1 patients)
    15%
    40 weeks

    BMI decrease from setmelanotide Phase 3 data at the 40-week time point in patients not on a concomitant GLP-1.

    Acquired HO estimated prevalence
    10,000
    current

    Estimated prevalence of acquired HO in the United States.

    Acquired HO estimated prevalence
    5,000 to 8,000
    current

    Estimated prevalence of acquired HO in Japan.

    HCPs engaged for acquired HO
    2,000+
    current

    Healthcare providers engaged who care for patients diagnosed with or suspected to have acquired HO.

    Priority medical centers for acquired HO
    40
    current

    Approximately 40 priority medical centers identified throughout the nation based on significant concentration of aHO patients.

    International organization employees
    100+
    FY25

    International organization grew to over 100 employees across 13 countries.

    IMCIVREE available countries
    25+8 newly added during the year
    FY25

    IMCIVREE is now available in more than 25 countries outside the United States.

    Abstracts accepted
    64
    2025

    64 abstracts (originals and encores) accepted for posters or oral presentations at 12 international and national scientific congresses.

    Industry KPIs

    6
    MetricValueDetails
    Launch access metrics3 to 9 monthsmonths
    Pipeline read out calendarMultiple readouts
    Product franchise net sales$57.3 millionUSD
    Regulatory approvals filingsPDUFA goal date
    Prescription volume new startsincreased by approximately 10%%
    Clinical trial efficacy safety data7.7% to 14.3% BMI reduction%

    Risks & headwinds

    5
    Inventory pull-forwardQ1 FY26

    $1.7 million in Q4 revenue from Q1 FY26

    Mitigation: Management acknowledges this dynamic and typical Q1 renewals/changes; the buildup of inventory this year is less than prior year.

    Bivamelagon Phase 3 regulatory requirementsLonger development timeline

    Full 12-month double-blind randomized controlled trial and larger safety database (closer to 142 patients) required

    Mitigation: Plan to run trial largely in countries where setmelanotide is not available for acquired HO to facilitate enrollment.

    Increased operating expensesFY26

    Anticipated $104.5 million increase in non-GAAP operating expenses for 2026 (35% over 2025)

    Mitigation: Framed as a 'meaningful opportunity to invest in Rhythm's long-term potential' across Bivamelagon/RM-718 development, HO launch, and Japan operations.

    PWS trial challengesOngoing

    Minimal threshold of 5% BMI change for success; acknowledged as a 'more challenging disease' with multiple genetic factors confounding results

    Mitigation: 17 of 18 patients remain on treatment, indicating perceived benefit; company will collect hunger scores and share data midyear.

    EMANATE study uncertaintyMarch 2026 readout

    SRC1 and some SH2B1 variants are of unknown significance, disproportionately benign, posing risk to positive readout

    Mitigation: Data will inform future studies with next-generation molecules; company will learn a lot from these studies regardless of outcome.

    What to watch in Q1 FY26

    5

    IMCIVREE HO PDUFA decision

    March 20, 2026
    CurrentUnder FDA review
    TargetApproval decision

    Why it matters

    Approval for acquired HO would significantly expand IMCIVREE's addressable market and revenue opportunity.

    As shown on Slide 13, we have multiple upcoming milestones with PDUFA for HO, top line data from our Japanese HO cohort and the EMANATE readout all coming in March.

    Q&A highlights

    8

    Are there any changes to enrollment criteria or other features for Bivamelagon Phase 3, given FDA feedback?

    The trial will largely mimic the setmelanotide Phase 3 in sample size and duration. Potential modifications to patient-reported outcome measures are being considered, but no specific FDA feedback was given on this.

    “I think to your point, the trial will largely mimic our Phase 3. We continue to look at our patient reported outcome measures. Are there other things we can do to get better and better at, for example, understanding hyperphagia/hunger.”

    asked by Derek Archila · answered by David Meeker

    2 min read5 chapters

    Detailed Narrative

    01

    Bivamelagon Phase 2 Data & FDA Feedback

    Rhythm Pharmaceuticals presented 9-month data from the Bivamelagon Phase 2 HO study, including 6 months on drug for original placebo patients. The data showed persistent BMI reductions and consistent safety and tolerability. The mean BMI decrease for the 400mg cohort at 40 weeks was 10.8%, and for the 600mg cohort, it was 14.3%. The FDA confirmed readiness for Phase 3 but requires a full 12-month double-blind randomized controlled trial and a larger safety database (closer to 142 patients), similar to the setmelanotide trial, for this new chemical entity. The company plans to run this trial largely in countries where setmelanotide will not be available for acquired HO.

    02

    Acquired Hypothalamic Obesity (HO) Launch Preparations

    The company is actively preparing for the acquired HO launch, pending regulatory approval by the March 20 PDUFA goal date. The sales force was expanded from 16 to 42 experienced rare disease specialists. Engagement efforts, leveraging claims data, have identified healthcare providers caring for over 2,000 patients diagnosed with or suspected of acquired HO. Payer coverage is expected within 3 to 9 months post-approval, building on established relationships from BBS, with ongoing engagement to secure access.

    03

    International Expansion & HO Opportunity

    IMCIVREE is now available in over 25 countries outside the US, with 8 new countries added in 2025, and the international organization has grown to over 100 employees across 13 countries. Japan represents a significant long-term opportunity for acquired HO, with an estimated prevalence of 5,000 to 8,000 patients. The company had a positive in-person meeting with the Japanese PMDA and anticipates top-line data from the Japanese HO cohort in March. The EMA submission for HO is under review, with a CHMP opinion expected in Q2 and EU marketing authorization in H2 2026.

    04

    Emanate & PWS Study Updates

    Top-line data for the EMANATE study is expected by the end of March. Management noted that POMC/LEPR substudies are considered higher probability for positive results due to patient enrollment and known pathogenicity of variants, while SRC1 and some SH2B1 variants carry higher risk. The Prader-Willi Syndrome (PWS) trial continues on track for full 6-month data by midyear, with 17 of 18 patients remaining on treatment, which is seen as encouraging given the challenging nature of the disease.

    05

    Next-Generation MC4R Agonists Development

    Development is underway for next-generation MC4R agonists, Bivamelagon and RM-718. Bioequivalent studies, drug-drug interaction studies, and hepatic impairment studies for Bivamelagon are expected to be completed by year-end, with the goal of initiating Phase 3 HO study by year-end 2026. The RM-718 weekly formulation is enrolling in HO, with initial 3-month data expected by midyear. The company aims to move these compounds through proof-of-concept and registrational studies to drive long-term growth.

    AI-generated summary of the company’s earnings call. Not investment advice.