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Rhythm Pharmaceuticals (RYTM) Q1 FY26 earnings call: guidance and Q&A

Earnings call· Mar 2026 (Q1 FY26)· Health Care· May 5, 2026

Source: earnings call transcript

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

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

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%
————

Risks & headwinds

Specialty pharmacy inventory pull-forward Q1 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 program Q1 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 policies 3-9 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

HO launch cadence (new patients/week)

Throughout 2026
Current ~20 new patients/week (excluding trial conversions)
Target Sustainable 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.

Find out whether RYTM delivers this. Inve re-checks your case every morning.

Q&A highlights

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 read 5 chapters

Detailed narrative

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.

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.

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.

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.

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.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.