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    RYTM
    Earnings call· Jun 2026(Q2 FY26)

    RHYTHM PHARMACEUTICALS Q2 FY26 earnings call RYTM

    Aug 4, 2026 Source

    Executive summary

    Rhythm Pharmaceuticals Q2 FY26 — Strong IMCIVREE HO Launch and Promising RM-718 Data

    Rhythm Pharmaceuticals delivered a strong Q2 FY26, driven by the successful U.S. launch of IMCIVREE for acquired hypothalamic obesity, which saw robust patient demand and prescriber engagement. The company also reported encouraging Phase II data for its next-generation weekly MC4R agonist, RM-718, showing comparable efficacy to existing treatments without hyperpigmentation. Despite a one-time international revenue adjustment, the company maintains a solid financial position and is advancing its pipeline and global commercialization efforts.

    Highlights

    5

    • Global net product sales totaled $71.3 million, representing 19% sequential growth over Q1 FY26.

    • U.S. launch of IMCIVREE for acquired hypothalamic obesity (HO) saw strong demand with over 400 start forms from approximately 300 prescribers in 14 weeks.

    • RM-718, a weekly MC4R agonist, demonstrated clinically meaningful BMI reductions of 11.6% at week 16 in HO patients, comparable to setmelanotide and bivamelagon, with no generalized hyperpigmentation.

    • Secured positive payer policies for HO covering approximately 25% of Medicaid and 35% of commercial covered lives by end of Q2 FY26.

    • Continued growth in patients on reimbursed therapy globally, increasing by over 20% quarter-over-quarter.

    Concerns

    2

    • International revenue decreased from $23.2 million in Q1 FY26 to $20.3 million in Q2 FY26, primarily due to a $3.8 million retrospective charge associated with the French contribution M mechanism.

    • Two patients discontinued RM-718 Phase II trial due to adverse events (injection site reactions, nausea) within the first 4 weeks of treatment.

    Guidance & targets

    9
    CategoryTargetConfidence
    Non-GAAP operating expenses
    $363 million to $397 million
    high materiality
    High
    Non-GAAP R&D expenses
    $175 million to $195 million
    medium materiality
    High
    Non-GAAP SG&A expenses
    $188 million to $202 million
    medium materiality
    High
    Cash runway
    sufficient to fund planned operations for at least 24 months
    high materiality
    High
    IMCIVREE approval and launch in Japan
    by year-end 2026
    high materiality
    High
    IMCIVREE launch in Germany for acquired HO
    in the first half of 2027
    medium materiality
    High
    IMCIVREE launches in other European countries for acquired HO
    in 2027 following Germany
    medium materiality
    Medium
    Initiate Phase III trial of bivamelagon in RH
    over the end of this year
    high materiality
    High
    Enrollment of PWS patients in Part D of RM-718 open-label trial
    complete by the end of the year
    medium materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    United States
    Generated $51 million in product revenue, representing 72% of global product revenue, driven by the strong start of the acquired HO launch and continued growth in BBS.
    Product revenue % of total: 72%
    		$51 million———
    International
    Revenue decreased to $20.3 million from $23.2 million in Q1 FY26, primarily due to a $3.8 million retrospective charge associated with the French contribution M mechanism, with $2.3 million related to 2025 revenue. Excluding this impact, the international business remains strong with continued patient growth.
    		$20.3 million———

    Operational metrics

    44
    Global net product sales
    $71.3 million19% sequential growth over Q1
    Q2 FY26

    Global net product sales of IMCIVREE totaled $71.3 million, which represents 19% sequential growth over Q1.

    Global net product sales
    $60.1 million
    Q1 FY26

    revenue increasing from $60.1 million in Q1 '26 to $71.3 million in Q2.

    U.S. product demand revenue growth
    $11.3 millionsequential
    Q2 FY26

    We saw an $11.3 million in revenue growth attributable to increased product demand in the U.S.

    International net product sales
    $23.2 million
    Q1 FY26

    International revenue decreased from $23.2 million to $20.3 million in Q2.

    Retrospective charge
    $3.8 million
    Q2 FY26

    the decrease in revenue was mainly attributable to a $3.8 million retrospective charge associated with the French contribution M mechanism, which levies a charge on pharmaceutical companies when reimbursed drug sales industry-wide exceeds specified statutory thresholds. $2.3 million of this $3.8 million charge was related to 2025 revenue.

    Gross-to-net (GTN)
    86%improved somewhat
    Q2 FY26

    GTN improved somewhat in the quarter to 86%, providing an additional support to Q2 revenue.

    Product shipments vs patient dispenses
    Exceeded by $2.9 million
    Q2 FY26

    product shipments to IMCIVREE specialty -- I'm sorry, to Rhythm Specialty Pharmacy exceeded patient dispenses by approximately 2.9 million, providing a modest benefit to revenue in the quarter.

    Inventory days
    20 daysincreased slightly
    as of June 30

    Inventory on [ Hampton Specialty Pharmacy ] increased slightly to 20 days as of June 30.

    Cost of goods sold as % of product revenue
    12.5%
    Q2 FY26

    Cost of goods sold this quarter was 12.5% of product revenue, within our normal range, and primarily driven by cost of materials and royalty payments on setmelanotide in conjunction -- I'm sorry, in connection with higher net product revenue during the quarter.

    R&D expenses
    $43.4 millionincreased $1.7 million sequentially compared to Q1 2026; compared to $42.3 million in Q2 2025
    Q2 FY26

    R&D expenses were $43.4 million for the second quarter of 2026 compared to $42.3 million in the same period last year. Sequentially, R&D expenses increased $1.7 million compared to the first quarter of 2026.

    SG&A expenses
    $67.4 millionincreased $3.8 million or approximately 6% sequentially compared to Q1 2026; compared to $45.9 million in Q2 2025
    Q2 FY26

    SG&A expenses were $67.4 million for the second quarter of 2026 compared to $45.9 million in the prior period. Sequentially, SG&A expenses increased by $3.8 million or approximately 6% compared to the first quarter of 2026.

    Weighted average common shares outstanding
    68.6 million
    Q2 FY26

    Weighted average common shares outstanding were 68.6 million for Q2 2026.

    GAAP EPS
    -$0.73
    Q2 FY26

    GAAP EPS for the second quarter of 2026 was a net loss per basic and diluted share of $0.73, including $0.02 per share from accrued dividends on convertible preferred stock of $1.1 million.

    Cash used in operations
    $9 million
    Q2 FY26

    Cash used in operations was approximately $9 million during the quarter.

    Cash, cash equivalents and short-term investments
    $331 million
    end of Q2 FY26

    We ended the second quarter with approximately $331 million in cash, cash equivalents and short-term investments

    Non-GAAP operating expenses
    $110.9 million
    Q2 FY26

    For the second quarter, operating expenses of approximately $110.9 million included $26.1 million of stock-based compensation.

    IMCIVREE start forms for HO
    more than 400
    in 14 weeks since March 19

    Since approval on March 19, we have received more than 400 start forms from approximately 300 prescribers. This includes 66 start forms for converted trial patients

    Unique prescribers for HO
    approximately 300
    between March 19 and end of Q2

    approximately 300 unique prescribers for acquired HO.

    Prescribers with multiple HO patients
    approximately 20%
    Q2 FY26

    Approximately 20% of these physicians have prescribed IMCIVREE for more than 1 patient with acquired HO.

    HO patient age distribution
    21%
    Q2 FY26

    21% of prescriptions for patients ages 4 to 11

    HO patient age distribution
    18%
    Q2 FY26

    18% for patients 12 to 17

    HO patient age distribution
    12%
    Q2 FY26

    12% for patients 18 to 21.

    HO patients incident
    approximately 15%
    Q2 FY26

    approximately 15% of patients suffer the injury resulting in their acquired HO within the last 2 years.

    HO patients prevalent
    approximately 50%
    Q2 FY26

    approximately 50% of patients having their injury occur more than 10 years ago.

    HO prescriber mix
    43%
    Q2 FY26

    adult and pediatric endocrinologists accounting for 43% and 37% of prescribers, respectively.

    HO prescriber mix
    37%
    Q2 FY26

    adult and pediatric endocrinologists accounting for 43% and 37% of prescribers, respectively.

    HO prescriber mix (total endocrinologists)
    80%
    Q2 FY26

    80% of prescribers being endocrinologists (derived from 43% adult and 37% pediatric endocrinologists).

    Priority HO accounts activated
    65%
    by end of June

    We've made solid progress in penetrating our priority accounts with 65% activated by the end of June

    HO prescriptions from priority accounts
    almost 25%
    Q2 FY26

    almost 25% of prescriptions coming from these accounts.

    Medicaid HO coverage
    approximately 25%
    by end of Q2

    By the end of Q2, we secured positive policies for HO covering approximately 25% of Medicaid covered lives

    Commercial HO coverage
    35%
    by end of Q2

    and 35% of commercial covered lives.

    HO patients with GLP-1 experience
    about 50%
    Q2 FY26

    about 50% of our IMCIVREE-prescribed AHO patients had prior or current experience on GLP.

    HO patients currently on GLP-1
    about 25%
    Q2 FY26

    But currently, there's about 25% of the patients that are currently still on a GLP.

    RM-718 Phase II HO trial enrollment
    11
    Q2 FY26

    Eleven patients were enrolled

    RM-718 Phase II HO trial active patients
    8
    Q2 FY26

    and 8 patients remain on active therapy.

    RM-718 Phase II HO trial patients at week 16
    7
    Q2 FY26

    Seven patients have reached 16 weeks, and that is the data we are sharing here.

    RM-718 Phase II HO mean BMI reduction
    11.6%
    at week 16

    The mean BMI change of 11.6% for the 7 patients who have reached week 16 is shown on Slide 9.

    Setmelanotide HO mean BMI reduction
    10.1%
    at week 16

    In a pooled analysis of patients with HO in the Phase II and Phase III setmelanotide trials, the week 16 BMI reduction was 10.1%.

    Bivamelagon HO mean BMI reduction
    10.1%
    at week 14

    For bivamelagon at 600-milligram dose, mean BMI reduction for 7 patients at week 14 was 10.1%

    BBS territory managers
    10
    Q2 FY26

    we now have a new territory manager group dedicated to BBS with plans to grow this to 10 TMs.

    HO territory managers
    42
    Q2 FY26

    we have made a transition to focus our 42 territory managers exclusively on HO.

    Estimated HO patient population
    5,000 to 8,000
    current

    With approximately 5,000 to 8,000 patients living with acquired hypothalamic obesity in Japan

    Estimated HO patient population
    approximately 10,000
    current

    With an estimated prevalence of approximately 10,000 patients in Europe

    Medical congress abstracts
    approximately 75
    this year

    We have approximately 75 abstracts, both originals and encores submitted and presented and are slated for presentation this year in European and Japanese medical congresses

    Risks & headwinds

    5
    Discontinuation of RM-718 Phase II trial due to adverse eventsWithin first 4 weeks of treatment

    2 patients out of 11 enrolled

    Mitigation: N/A (acknowledged as part of trial, but overall tolerability profile favorable)

    Retrospective charge from French contribution M mechanism impacting international revenueQ2 FY26

    $3.8 million ($2.3 million related to 2025 revenue)

    Mitigation: N/A (statutory charge)

    Busy endocrinology offices and long wait times impacting speed of HO uptakeOngoing

    N/A

    Mitigation: Teams are persistent in engaging HCPs.

    Patients not yet diagnosed with HOOngoing

    N/A

    Mitigation: Education of physicians, patient evaluation by HCPs.

    Physicians wanting to gain experience with IMCIVREE before prescribing to all patientsEarly launch phase

    N/A

    Mitigation: N/A (natural part of new drug adoption).

    What to watch in Q3 FY26

    5

    IMCIVREE HO launch patient start forms

    Next quarter
    Current>400 in 14 weeks
    TargetSustained growth beyond initial urgency

    Why it matters

    Indicates the durability and long-term trajectory of the HO market opportunity.

    all of the launch metrics that we have been really monitor -- strengthen our belief holistically in terms of this long-term opportunity for sustained ongoing growth in the HO opportunity.

    Q&A highlights

    5

    What are the expectations for discontinuation rates for IMCIVREE in HO, and how might they compare to BBS?

    It's too early to provide specific HO discontinuation rates. However, the global BBS discontinuation rate was around 30%. HO patients may have lower discontinuation rates due to stronger efficacy seen in clinical studies and potentially easier injection experience. The company is actively monitoring this.

    “holistically, there are differences just in terms of what our data has shown in the BBS patient population versus the HO population in terms of the strength of efficacy that may make that discount rate lower in this particular population.”

    asked by Tazeen Ahmad · answered by Jennifer Chien

    2 min read6 chapters

    Detailed Narrative

    01

    IMCIVREE U.S. HO Launch Progress

    The U.S. launch of IMCIVREE for acquired hypothalamic obesity (HO) has shown strong early demand, with over 400 start forms received from approximately 300 unique prescribers in the first 14 weeks post-FDA approval. Prescriptions are evenly split between patients 21 and younger and those 22 and older, with pediatric patients making up a larger share of early prescriptions. The majority of prescribers are endocrinologists (43% adult, 37% pediatric), and 65% of priority accounts have been activated.

    02

    RM-718 Phase II Data

    Preliminary open-label Phase II Part C trial data for RM-718, a weekly MC4R agonist, in acquired HO patients showed a mean BMI reduction of 11.6% at week 16 for 7 patients. These results compare favorably to setmelanotide (10.1% BMI reduction at week 16) and bivamelagon (10.1% BMI reduction at week 14) in similar patient populations. RM-718 was generally well tolerated, with no observed generalized hyperpigmentation, validating its potential as a viable treatment option.

    03

    International Expansion for HO

    The European Commission granted marketing authorization for IMCIVREE in acquired HO in May. The company anticipates launching in Germany in H1 2027, with other European countries (France, UK, Italy, Spain, Netherlands) following in 2027. In Japan, IMCIVREE approval for acquired HO and launch are anticipated by year-end 2026, with pricing discussions expected to take 2-3 months post-marketing authorization.

    04

    Prader-Willi Syndrome (PWS) Program

    Positive 6-month data from the setmelanotide trial in PWS were presented at ENDO, showing clinically meaningful BMI and BMI-Z score reductions, fat mass reduction, lean mass preservation, and improvements in hyperphagia and anxiety. The company expects to update on the path forward for PWS in the next few months⏳, considering setmelanotide, bivamelagon, or RM-718 as viable options. Enrollment of PWS patients in Part D of the RM-718 open-label trial is expected to complete by year-end.

    05

    Payer and GLP-1 Dynamics

    Early payer experience for HO has been positive, with positive policies covering approximately 25% of Medicaid and 35% of commercial covered lives by Q2 end, without GLP-1 step-edit requirements. Approximately 50% of IMCIVREE-prescribed HO patients had prior or current GLP-1 experience, with 25% currently on GLP-1s, indicating an unmet need addressed by IMCIVREE.

    06

    Commercial Organization Evolution

    Rhythm is evolving its North America commercial organization, dedicating 42 territory managers exclusively to HO and establishing a new group of 10 territory managers for BBS. This aims to ensure focused execution for both opportunities and maximize patient reach.

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