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    RYTM
    Earnings call· Mar 2026(Q1 FY26)

    RHYTHM PHARMACEUTICALS Q1 FY26 earnings call RYTM

    May 5, 2026 Source

    Executive summary

    Rhythm Pharmaceuticals Q1 FY26 — Strong HO Launch and Pipeline Progress

    Rhythm Pharmaceuticals reported strong Q1 FY26 results, driven by robust initial uptake of IMCIVREE for acquired hypothalamic obesity (HO) in the U.S. and significant regulatory progress in Europe and Japan. The company is advancing its pipeline, including new formulations and next-generation therapies, while maintaining a solid financial position to support future growth and address unmet needs in rare genetic obesity disorders.

    Highlights

    5

    • Global net revenues reached $60.1 million in Q1 FY26, representing 5% sequential growth over Q4 FY25.

    • IMCIVREE for acquired Hypothalamic Obesity (HO) received over 150 start forms in six weeks post-approval, with approximately 80% from new prescribers.

    • The European Commission granted marketing authorization for IMCIVREE in acquired HO, with launches anticipated to begin in 2027.

    • The Japanese PMDA accepted the NDA filing for IMCIVREE in acquired HO, with anticipated approval and launch by the end of 2026.

    • The company ended Q1 FY26 with approximately $341 million in cash, cash equivalents, and short-term investments, expected to fund operations for at least 24 months.

    Concerns

    3

    • U.S. revenue in Q1 FY26 was impacted by a $1.8 million specialty pharmacy inventory pull-forward in Q4 FY25.

    • A temporary increase in patients receiving free drug through the bridge program occurred in Q1 FY26 due to insurance plan transitions.

    • The launch trajectory for acquired HO in Japan is difficult to forecast compared to the U.S. due to different regulatory timelines and market dynamics.

    Guidance & targets

    8
    CategoryTargetConfidence
    Non-GAAP operating expenses
    $385M-$415M
    high materiality
    High
    Non-GAAP R&D expenses
    $197M-$213M
    medium materiality
    High
    Non-GAAP SG&A expenses
    $188M-$202M
    medium materiality
    High
    Cash runway
    Sufficient for at least 24 months
    high materiality
    High
    IMCIVREE for acquired HO (Japan) approval and launch
    Anticipated approval and launch by the end of 2026
    high materiality
    High
    IMCIVREE for acquired HO (Europe) launches
    Anticipated to begin in 2027
    high materiality
    High
    IMCIVREE for acquired HO (Germany) launch
    Launch in 2027
    medium materiality
    High
    Phase III trial for bivamelagon in HO
    Start by the end of 2026
    high materiality
    High

    Segment performance

    4
    SegmentRevenueYoYQoQMargin
    United States
    U.S. revenue impacted by a $1.8M Q4 FY25 specialty pharmacy inventory pull-forward and a temporary increase in patients on the bridge program due to insurance transitions in Q1 FY26.
    		$36.66M———
    International
    Growth driven by increased sales volumes in Germany and France, as well as certain named patient sales markets like Saudi Arabia and Greece. Named patient sales can result in more variable quarterly revenue growth due to longer lead times.
    		$23.2M—27% sequential increase—
    Bardet-Biedl Syndrome (BBS)
    Steady, consistent growth over the last three years. Temporary increase in patients on free drug through bridge program in Q1 FY26 due to insurance transitions, now returned to Q4 levels.
    IMCIVREE prescriptions: steady growthPatients on reimbursed therapy: primary driver of 8% QoQ global increase
    		————
    Acquired Hypothalamic Obesity (HO)
    Strong U.S. launch start. Broad label includes causes beyond tumor/tumor treatment-related HO. Payer receptivity encouraging, with initial reimbursement approvals; formal policies expected in 3-9 months.
    IMCIVREE start forms: >150 in 6 weeksClinical trial patient conversions: ~40 start formsUnique prescribers: ~110New prescribers of IMCIVREE: ~80%Prescribers who are endos: ~80%
    		————

    Operational metrics

    33
    Global net revenues
    $60.1M5% sequential growth
    Q1 FY26

    Global net revenues from sales of IMCIVREE.

    Global net revenues
    $57M
    Q4 FY25

    Prior quarter global net revenues.

    U.S. revenue contribution
    61%
    Q1 FY26

    Percentage of total global net revenues generated in the United States.

    International revenue
    $23.2M27% sequential increase
    Q1 FY26

    Revenue generated outside the U.S.

    International revenue
    $18.3M
    Q4 FY25

    Prior quarter international revenue.

    Global patients on reimbursed therapy
    8%over prior quarter
    Q1 FY26

    Increase in global patients on reimbursed therapy, primarily driven by BBS.

    Specialty pharmacy inventory pull-forward
    $1.8M
    Q4 FY25

    Inventory increase in Q4 FY25 that pulled sales forward, affecting U.S. revenue in Q1 FY26.

    U.S. gross-to-net
    84%consistent with recent quarters
    Q1 FY26

    Gross-to-net for U.S. sales.

    Cost of goods sold as % of product revenue
    11.9%
    Q1 FY26

    Within normal range, primarily driven by cost of materials and royalty payments.

    R&D expenses
    $41.7Mvs $37M in Q1 FY25
    Q1 FY26

    Year-over-year increase primarily attributable to headcount-related costs.

    SG&A expenses
    $63.6Mvs $39.1M in Q1 FY25
    Q1 FY26

    Year-over-year increase primarily reflected higher headcount-related costs and marketing activities for HO launch.

    SG&A expenses sequential increase
    $6.1M11% compared to Q4 FY25
    Q1 FY26

    Sequential increase in SG&A expenses.

    Weighted average common shares outstanding
    68M
    Q1 FY26

    Shares outstanding for Q1 FY26.

    Cash used in operations
    $44.2M
    Q1 FY26

    Cash outflow from operating activities during the quarter.

    GAAP EPS
    -$0.83
    Q1 FY26

    Net loss per basic and diluted share.

    Accrued dividends on convertible preferred stock per share
    $0.02
    Q1 FY26

    Portion of GAAP EPS from accrued dividends.

    Accrued dividends on convertible preferred stock
    $1.1M
    Q1 FY26

    Total accrued dividends on convertible preferred stock.

    Cash, cash equivalents and short-term investments
    $341M
    Q1 FY26

    Balance at the end of the first quarter.

    Non-GAAP operating expenses
    $82.2M
    Q1 FY26

    Non-GAAP operating expenses for the quarter, excluding stock-based compensation.

    Stock-based compensation
    $23.1M
    Q1 FY26

    Included in total operating expenses.

    HO patient prevalence
    10,000
    estimated

    Estimated prevalence of acquired HO patients.

    HO patient prevalence
    5,000-8,000
    estimated

    Estimated prevalence of acquired HO patients in Japan.

    BBS patient prevalence
    5,000
    estimated

    Estimated prevalence of Bardet-Biedl Syndrome patients in the U.S.

    HO opportunity size vs BBS
    2x
    estimated

    Acquired HO opportunity is approximately twice the size of BBS.

    Sales representatives (BBS)
    16
    prior to HO launch

    Number of sales representatives for BBS prior to scaling for HO.

    Sales representatives (total)
    42
    current

    Total sales representatives deployed across the country, scaled for HO opportunity.

    HO start forms received
    >150
    first 6 weeks post-approval

    Number of start forms received for IMCIVREE in acquired HO.

    HO start forms from clinical trial patients
    ~40
    first 6 weeks post-approval

    Portion of HO start forms from patients converting from clinical trials.

    Unique HO prescribers
    ~110
    first 6 weeks post-approval

    Number of unique physicians prescribing IMCIVREE for acquired HO.

    New prescribers of IMCIVREE (for HO)
    ~80%
    first 6 weeks post-approval

    Percentage of unique HO prescribers who are new to IMCIVREE.

    HO prescribers who are endocrinologists
    ~80%
    early launch

    Percentage of HO prescribers who are endocrinologists, along with some pediatricians and primary care physicians.

    Japan employees
    ~50
    current

    Number of employees in Japan for pre-launch activities.

    International patients on reimbursed therapy growth
    double-digit percent growthQoQ
    Q1 FY26

    Growth in patients on reimbursed therapy across more than 25 countries, with BBS as a primary driver and early access programs for HO contributing meaningfully.

    Industry KPIs

    2
    MetricValueDetails
    Pipeline read out calendarPWS 6-month data, RM-718 data, Bivamelagon Phase III start
    Regulatory approvals filingsIMCIVREE for acquired HO

    Risks & headwinds

    4
    Specialty pharmacy inventory pull-forwardQ1 FY26 impact

    $1.8M in Q4 FY25

    Mitigation: Not explicitly stated, but inventory changes did not significantly impact Q1 revenue.

    Temporary increase in patients on free drug bridge programQ1 FY26

    Not quantified, but impacted Q1 FY26 U.S. revenue

    Mitigation: Patient support teams worked with patients, payers, and HCPs; number of patients on bridge therapy has since returned to Q4 levels.

    Variability in international named patient sales revenue

    Can result in more variable quarterly revenue growth

    Mitigation: Not explicitly stated, but acknowledged as a characteristic of these markets.

    Time to establish HO-specific IMCIVREE payer policies3-9 months post-approval

    Approximately three to nine months from approval

    Mitigation: Prior education for BBS has facilitated discussions and understanding; initial approvals for reimbursement are being seen.

    What to watch in Q2 FY26

    5

    HO launch cadence (new patients/week)

    Throughout 2026
    Current~20 new patients/week (excluding trial conversions)
    TargetSustainable steady growth

    Why it matters

    Indicates the underlying demand and long-term trajectory of the key new product launch.

    But the vast majority of the patients or the physicians are waiting to have those conversations with their patients as they come in for their regularly scheduled visits. So that will flow through on, I would say, more of a steady pace moving forward.

    Q&A highlights

    5

    Can you provide an update on the total number of identified patients for HO, and how many of the received start forms came from pre-identified patients versus newly discovered ones?

    The previously stated 2,000+ identified patient number has increased but will no longer be updated; the focus is now on start forms. The vast majority of the 150+ start forms received came from physicians who had been engaged by the field teams prior to approval, indicating strong initial activation.

    “So many of those start forms that we've received, if you take a look at them, have come from the list of physicians that we educated prior to approval. I would say that overall, the vast majority of these start forms were from physicians that our field teams had some type of engagement with prior to approval.”

    asked by Phil Nadeau · answered by Jennifer Chien

    2 min read5 chapters

    Detailed Narrative

    01

    Acquired Hypothalamic Obesity (HO) Launch Dynamics

    The U.S. commercial launch of IMCIVREE for acquired HO is off to a strong start, with over 150 start forms received in six weeks, including approximately 40 from clinical trial patients. Approximately 80% of the 110 unique prescribers are new to IMCIVREE, primarily endocrinologists. Payer receptivity is encouraging, with initial reimbursement approvals, though formal HO-specific policies are expected to be established within three to nine months. The broad label, covering various causes of HO, provides significant opportunity for physician education beyond tumor-related cases, which currently represent the vast majority of patients.

    02

    International Expansion for HO

    The European Commission granted marketing authorization for IMCIVREE in acquired HO, with launches anticipated to begin in 2027. The company is actively pursuing country-level reimbursement negotiations, including seeking an exemption from Germany's exclusion list for lifestyle drugs, a process expected to take six to nine months. In Japan, the PMDA has accepted the NDA filing for IMCIVREE in acquired HO, with approval and launch anticipated by the end of 2026, driven by strong KOL support and a significant unmet need in an estimated 5,000-8,000 patients. The company has nearly 50 employees in Japan and is executing pre-launch tactics.

    03

    Bardet-Biedl Syndrome (BBS) Performance

    The base business, predominantly Bardet-Biedl Syndrome (BBS), showed steady growth in Q1 FY26. While there was a temporary increase in patients on the bridge program due to insurance transitions at the beginning of the year, most have since moved back to reimbursed therapy. The company continues to adapt and optimize its approach to identifying and treating BBS patients, leveraging lessons learned from the initial launch to unlock long-term opportunities.

    04

    Pipeline and Life Cycle Management

    Rhythm is pursuing a life cycle management strategy with next-generation therapies. This includes ongoing CMC work and bioequivalent studies for bivamelagon, with the goal of starting a Phase III trial in HO by the end of 2026. The company is also continuing work on genetic causes of MC4R pathway impairment, focusing on clarifying variants with true loss of function for future trials with next-generation therapies, and building out its early research function focused on programs like CHI.

    05

    Prader-Willi Syndrome (PWS) Data Updates

    The company anticipates sharing 6-month data from Dr. Miller's PWS study at the endo meeting in June, which is expected to include BMI, HQCT, and DEXA scan data. Further RM-718 data (from a smaller patient set) and potentially additional available PWS data will be shared around the Q2 earnings call. Management expects IMCIVREE to provide both a reduction in hyperphagia symptoms and a decrease in weight/BMI in PWS patients, based on its satiety signal mechanism.

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