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Rhythm Pharmaceuticals, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 4 August 2026: press release. Guidance figures: 2 lowered, 2 kept. The quarter’s numbers.

Key takeaways

  • Product revenue rose 19% sequentially: Global IMCIVREE revenue was $71.3 million, up from $48.5 million in the second quarter of 2025. Management attributed the sequential growth mainly to U.S. acquired HO demand and continued BBS demand. Source
  • U.S. revenue rose 38% sequentially: U.S. revenue was $51.0 million, 72% of product revenue, up $14.1 million from the first quarter. Management attributed the sequential increase primarily to patient demand for IMCIVREE in acquired HO. Source
  • Over 400 acquired HO start forms: More than 400 patient start forms for acquired HO had been received from approximately 300 prescribers by June 30, 2026, since FDA approval on March 19, 2026. The earlier count, in the first-quarter release, was more than 150 within six weeks. Source
  • RM-718 showed 11.6% BMI reduction: Preliminary Part C data from the Phase 1/2 study covered seven patients with acquired HO. The company announced the data the same day as its quarterly results. Source
  • Prader-Willi six-month data presented: The open-label Phase 2 trial in PWS reported fat mass reductions with lean mass preserved, plus improvements in hyperphagia and anxiety measures. Source
  • SG&A rose on personnel costs: SG&A rose from $45.9 million a year earlier, driven by personnel costs including stock-based compensation. SG&A was $63.6 million in the first quarter. Source
  • Cash and investments fell to $330.9 million: Cash, cash equivalents and short-term investments were $330.9 million at June 30, 2026, down from $388.9 million at December 31, 2025. Source

“The demand we are seeing from both patients and physicians reinforces the significant unmet need in acquired HO”

David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm Pharmaceuticals

Guidance

AreaPeriodFigureAgainst last quarter
Non-GAAP operating expenses Sourceyear ending December 31, 2026$363 million to $397 millionLowered from $385 million to $415 million
R&D expenses (GAAP, component of non-GAAP operating expenses) Sourceyear ending December 31, 2026approximately $175 million to $195 millionLowered from approximately $197 million to $213 million
SG&A expenses (GAAP, component of non-GAAP operating expenses) Sourceyear ending December 31, 2026approximately $188 million to $202 millionKept
Cash runway Sourceat least 24 months from June 30, 2026at least 24 monthsKept

What changed from last quarter

  • Guidance lowered: The 2026 non-GAAP operating expense range was lowered to $363 million to $397 million from $385 million to $415 million. Source
  • Guidance lowered: The 2026 R&D expense range was lowered to approximately $175 million to $195 million from approximately $197 million to $213 million. Source
  • Guidance kept: The 2026 SG&A expense range is unchanged at approximately $188 million to $202 million. Source

Results and growth drivers

  • Product revenue rose 19% sequentially: Global IMCIVREE revenue was $71.3 million, up from $48.5 million in the second quarter of 2025. Management attributed the sequential growth mainly to U.S. acquired HO demand and continued BBS demand. Source
  • Net loss attributable rose year over year: Net loss attributable to common stockholders was $(48.0) million a year earlier, at $(0.75) per share. Weighted-average shares were 68.6 million, up from 63.7 million. Source
  • Six-month product revenue reached $131.4 million: First-half IMCIVREE product revenue compares with $86.2 million in the first half of 2025. First-half net loss attributable to common stockholders was $(107.1) million, or $(1.57) per share. Source

Segments and regions

  • U.S. revenue rose 38% sequentially: U.S. revenue was $51.0 million, 72% of product revenue, up $14.1 million from the first quarter. Management attributed the sequential increase primarily to patient demand for IMCIVREE in acquired HO. Source
  • Ex-U.S. revenue fell 13% sequentially: Ex-U.S. revenue was $20.3 million, 28% of product revenue, down $2.9 million from the first quarter. The number of reimbursed patients on IMCIVREE continued to increase. Source
  • Contribution M charge in France: A $3.8 million retrospective charge under France's Contribution M mechanism is recorded in the ex-U.S. figures. Of that amount, $3.1 million relates to revenue from periods before the second quarter. Source

“During the quarter, we strengthened Rhythm’s foundation for long-term growth with positive Phase 2 results for setmelanotide in Prader-Willi syndrome (PWS), as well as positive RM-718 results in acquired HO patients.”

David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm Pharmaceuticals

Demand and patient uptake

  • Over 400 acquired HO start forms: More than 400 patient start forms for acquired HO had been received from approximately 300 prescribers by June 30, 2026, since FDA approval on March 19, 2026. The earlier count, in the first-quarter release, was more than 150 within six weeks. Source
  • BBS demand kept growing: Management cited continued growth in demand in Bardet-Biedl syndrome as a contributor to the sequential U.S. increase, alongside acquired HO demand. Source
  • Reimbursed patients rose over 20%: The reimbursed patient figure is reported at the global level, covering both U.S. and ex-U.S. patients on IMCIVREE. Source

Products and pipeline data

  • RM-718 showed 11.6% BMI reduction: Preliminary Part C data from the Phase 1/2 study covered seven patients with acquired HO. The company announced the data the same day as its quarterly results. Source
  • Prader-Willi six-month data presented: The open-label Phase 2 trial in PWS reported fat mass reductions with lean mass preserved, plus improvements in hyperphagia and anxiety measures. Source
  • TRANSCEND results published in NEJM: The publication by Dr. Jennifer Miller and colleagues was accompanied by a 'Science Behind the Study' editorial by Professor Sadaf Farooqi. Source
  • Consensus BBS diagnostic algorithm published: The peer-reviewed paper was announced on May 28, 2026, and is the basis for the new diagnostic approach described in it. Source

“we remain focused on expanding treatment options for patients and realizing the potential of our pipeline of MC4R agonists.”

David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm Pharmaceuticals

Costs and operating expenses

  • SG&A rose on personnel costs: SG&A rose from $45.9 million a year earlier, driven by personnel costs including stock-based compensation. SG&A was $63.6 million in the first quarter. Source
  • R&D rose on personnel and genetic testing: Higher personnel costs, data analytics for genetic testing, pre-clinical expense and bivamelagon trials were partly offset by lower CMC activity and trial costs. Source
  • Six-month R&D rose on headcount: First-half R&D expense was $85.2 million, with the increase driven by personnel costs for research and development programs, partly offset by lower CMC and clinical trial expenses. Source
  • Other expense narrowed: Other expense, net improved from $(1.0) million, mainly from lower non-cash interest expense tied to the LG Chem liability. Source

Capital, cash and balance sheet

  • Cash and investments fell to $330.9 million: Cash, cash equivalents and short-term investments were $330.9 million at June 30, 2026, down from $388.9 million at December 31, 2025. Source
  • Preferred shares outstanding declined: Series A convertible preferred stock was carried at $114.3 million, with 115,000 shares outstanding against 132,500 at year-end. Accrued preferred dividends were $1,065 thousand in the quarter. Source
  • Receivables and inventory increased: Accounts receivable rose to $40.4 million and inventory to $30.5 million, from year-end amounts of $26.1 million and $25.8 million. Source

Medical meetings and pipeline

  • Six ESPE abstracts accepted: Three oral and three poster abstracts cover pediatric acquired HO and BBS, including final Phase 3 pediatric results, for presentation at ESPE 2026. Source
  • Long-term weight data at ECO: Five-year BBS weight outcomes and six-year POMC or LEPR outcomes were presented, along with a 52-week indirect comparison in children aged 2 to 5 years. Source
  • Pipeline spans several rare diseases: Management described a broad program in other rare diseases, two investigational MC4R agonists, and preclinical small molecules for congenital hyperinsulinism. Source

Coming up, as management said on 4 August 2026

  • Japan decision and launch: Launch of IMCIVREE for acquired HO in Japan is anticipated, pending a decision by MHLW by year-end 2026. Source
  • Bivamelagon pivotal Phase 3 start: A pivotal Phase 3 trial of bivamelagon in acquired HO is to be initiated by year-end 2026. Source
  • European country launches in 2027: Country-level launches of IMCIVREE for acquired HO in Europe are anticipated beginning in 2027. Source
  • Congenital HO substudy enrollment: Enrollment in the setmelanotide substudy in congenital HO is expected to complete in the second half of 2026. Source
  • RM-718 PWS Part D enrollment: Enrollment in the Phase 1/2 Part D trial of RM-718 in PWS is expected to complete in the second half of 2026. Source

Figures management reported

FigureReported
IMCIVREE product revenue, global Source$71.3 million (second quarter of 2026)
IMCIVREE product revenue, U.S. Source$51.0 million (72% of product revenue)
IMCIVREE product revenue, ex-U.S. Source$20.3 million (28% of product revenue)
R&D expense Source$43.4 million (second quarter of 2026)
FDA approval, acquired HO SourceMarch 19, 2026
Trial readout, RM-718 Part C Source11.6% mean BMI reduction (n=7, 16 weeks)
Publication, TRANSCEND Phase 3 SourcePublished in NEJM, July 8, 2026
Japan approval decision, acquired HO SourcePending; decision expected by year-end 2026

Risks management discussed

  • Regulatory: Management cited a retrospective charge under France's Contribution M mechanism, which affected ex-U.S. revenue in the quarter. Source

Earlier plans management reported on

  • Not stated: The first-quarter release planned this announcement for the second quarter; the six-month data were presented at ENDO on June 13, 2026. Source
  • Not stated: The first-quarter release anticipated a PMDA decision in the second half of 2026. This release cites a decision by MHLW by year-end 2026. Source
  • Not stated: The first-quarter release expected Part C results at mid-year 2026. Preliminary Part C data were announced with these results. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.