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Rhythm Pharmaceuticals, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 3 November 2026: press release. Guidance figures: 1 raised, 2 lowered, 1 kept. The quarter’s numbers.

Key takeaways

  • IMCIVREE revenue rose 29% sequentially: Global IMCIVREE net product revenue was $92.1 million, up 29% from the second quarter and up from $51.3 million a year earlier. Source
  • U.S. revenue rose 32% sequentially: U.S. revenue was $67.5 million, 73% of product revenue, up $16.5 million or 32% from the second quarter, driven by acquired HO and BBS demand. Source
  • Japan launch for acquired HO started: Japan's health ministry approved IMCIVREE for acquired HO on August 24, 2026; the launch was announced October 13. Management called Japan a market with potential to become its second largest. Source
  • 700 plus patient start forms received: More than 700 patient start forms for acquired HO, from more than 500 prescribers, had been received after the March 19, 2026 FDA approval, as of September 30, 2026. Source
  • Operating expense guidance range lowered: Full-year non-GAAP operating expense guidance is now $360 million to $380 million, compared with $363 million to $397 million in the prior release. Source
  • Cash balance fell to $320.9 million: Cash, cash equivalents and short-term investments were $320.9 million at September 30, 2026, against $388.9 million at December 31, 2025, excluding the $250 million term loan draw and the LG Chem payment. Source
  • LG Chem royalty cut for $350M: Rhythm will pay LG Chem $350 million in fixed payments over four years; the bivamelagon royalty falls from low-to-mid single digit to 1% of MC4R portfolio net product revenue. Source
  • Bivamelagon moves into Prader-Willi pivotal: Bivamelagon will advance into pivotal development in Prader-Willi syndrome; a 6-month hyperphagia study is planned for 2027, pending FDA alignment. Source

“Our commercial launch in Japan represents another important milestone in a market with the potential to become our second largest,”

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$360 million to $380 millionLowered from $363 million to $397 million
R&D expenses (GAAP) Sourceyear ending December 31, 2026approximately $165 million to $175 millionLowered from approximately $175 million to $195 million
SG&A expenses (GAAP) Sourceyear ending December 31, 2026approximately $195 million to $205 millionRaised from approximately $188 million to $202 million
Liquidity runway Sourceat least 24 months from September 30, 2026at least 24 monthsKept

What changed from last quarter

  • Guidance lowered: Full-year non-GAAP operating expense range lowered and narrowed to $360 million to $380 million. Source
  • Guidance lowered: Full-year GAAP R&D expense range lowered to $165 million to $175 million. Source
  • Guidance raised: Full-year GAAP SG&A expense range raised to $195 million to $205 million. Source
  • Guidance kept: Cash runway guidance of at least 24 months is unchanged from the prior release. Source
  • New: Commercial launch of IMCIVREE in Japan for acquired HO announced October 13, 2026. Source
  • New: Bivamelagon license with LG Chem amended; royalty cut to 1% in exchange for $350 million in fixed payments. Source
  • New: Five-year term loan facility of up to $750 million entered; amended and restated revenue interest financing agreement signed. Source
  • New: Manher ('AJ') Joshi, M.D., named Chief Medical Officer, announced August 17, 2026. Source
  • New: Non-GAAP operating expense definition now also excludes fixed consideration for milestone payments. Source
  • New: Bivamelagon program headline: advance into pivotal development in Prader-Willi syndrome. Source

Results and growth drivers

  • IMCIVREE revenue rose 29% sequentially: Global IMCIVREE net product revenue was $92.1 million, up 29% from the second quarter and up from $51.3 million a year earlier. Source
  • Nine-month product revenue reached $223.5 million: Year-to-date product revenue was $223.5 million, compared with $137.5 million for the first nine months of 2025. Source
  • Net loss narrowed year over year: Net loss attributable to common stockholders was $42.4 million, or $(0.61) per share, against $54.3 million, or $(0.82) per share, a year earlier. Source
  • Reimbursed patients grew 20%: The number of patients on reimbursed therapy globally rose 20% from the second quarter, the company reported. Source

Segments and regions

  • U.S. revenue rose 32% sequentially: U.S. revenue was $67.5 million, 73% of product revenue, up $16.5 million or 32% from the second quarter, driven by acquired HO and BBS demand. Source
  • Japan launch for acquired HO started: Japan's health ministry approved IMCIVREE for acquired HO on August 24, 2026; the launch was announced October 13. Management called Japan a market with potential to become its second largest. Source
  • Ex-U.S. revenue rose 22% sequentially: Ex-U.S. revenue was $24.7 million, 27% of product revenue, a sequential increase of $4.4 million or 22%. Reimbursed patients outside the U.S. continued to increase. Source
  • Canadian and UK approvals reported: Health Canada approved IMCIVREE for acquired HO on September 22, 2026, and the UK authorization was expanded on August 11, 2026. European country launches begin with Germany in 2027. Source

“The strength of the U.S. launch through two quarters reinforces both the significant unmet need in acquired HO”

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

Products and customers

  • 700 plus patient start forms received: More than 700 patient start forms for acquired HO, from more than 500 prescribers, had been received after the March 19, 2026 FDA approval, as of September 30, 2026. Source
  • U.S. growth from HO and BBS: Sequential U.S. growth was driven mainly by patient demand for IMCIVREE in acquired HO, with continued growth in demand in Bardet-Biedl syndrome. Source

Costs and operating expenses

  • Operating expense guidance range lowered: Full-year non-GAAP operating expense guidance is now $360 million to $380 million, compared with $363 million to $397 million in the prior release. Source
  • R&D guidance range lowered: GAAP R&D guidance is $165 million to $175 million, down from $175 million to $195 million. Source
  • SG&A guidance range raised: GAAP SG&A guidance is $195 million to $205 million, up from $188 million to $202 million. Source
  • Quarterly R&D and SG&A rose: Third-quarter R&D was $52.5 million and SG&A was $66.8 million, both higher than a year earlier, with R&D citing CMC, trial, personnel and milestone costs. Source
  • Cost of sales more than doubled: Cost of sales was $12.2 million in the third quarter against $5.5 million a year earlier; nine-month cost of sales was $28.3 million against $14.7 million. Source
  • Non-GAAP definition now excludes milestones: Non-GAAP operating expenses now also exclude fixed consideration for milestone payments, in addition to in-licensing and stock-based compensation. Source

“We are excited about advancing our next-generation MC4R agonists, beginning with bivamelagon.”

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

Cash, capital and financing

  • Cash balance fell to $320.9 million: Cash, cash equivalents and short-term investments were $320.9 million at September 30, 2026, against $388.9 million at December 31, 2025, excluding the $250 million term loan draw and the LG Chem payment. Source
  • Term loan of up to $750 million: A five-year term loan led by KKR's HealthCare Royalty with Blackstone Life Sciences provides access to up to $750 million; the initial draw was $250 million. Source
  • LG Chem royalty cut for $350M: Rhythm will pay LG Chem $350 million in fixed payments over four years; the bivamelagon royalty falls from low-to-mid single digit to 1% of MC4R portfolio net product revenue. Source
  • Cash runway kept at 24 months: Management said cash supports planned operations for at least 24 months, based on the September 30, 2026 balance and current operating plans. Source
  • Lower interest income raised other expense: Other expense, net was $(1.5) million against $(0.1) million a year earlier, as interest income fell with lower average cash and short-term investments. Source

Pipeline and strategy

  • Bivamelagon moves into Prader-Willi pivotal: Bivamelagon will advance into pivotal development in Prader-Willi syndrome; a 6-month hyperphagia study is planned for 2027, pending FDA alignment. Source
  • Bivamelagon Phase 3 in acquired HO: A pivotal Phase 3 trial of bivamelagon in acquired HO is to start by year-end 2026. Source
  • RM-718 enrollment in PWS: Enrollment in the Part D trial of RM-718 in Prader-Willi syndrome is expected to complete in the second half of 2026. Source
  • Congenital HO enrollment moved to 2027: Enrollment in the setmelanotide congenital HO substudy is now expected to complete in 2027; the prior release gave the second half of 2026. Source

Leadership and medical meetings

  • Chief Medical Officer appointed: Manher ('AJ') Joshi, M.D. was appointed Chief Medical Officer, as announced August 17, 2026. Source
  • Five ObesityWeek presentations accepted: Five presentations were accepted for ObesityWeek 2026, covering HO diagnostic criteria, TRANSCEND patient-reported outcomes and two-year Phase 3 results. Source
  • Six ESPE abstracts presented: Six abstracts, including three oral and three poster presentations, were presented at the ESPE Meeting, as announced September 10, 2026. Source

Coming up, as management said on 3 November 2026

  • ObesityWeek presentations in November: Five ObesityWeek 2026 presentations are scheduled for November 14-17, 2026. Source
  • Payment to LG Chem due: A $70 million payment to LG Chem is due under the amended bivamelagon licensing agreement; the release gives no date. Source
  • Germany first European launch in 2027: Country-level launches of IMCIVREE for acquired HO in Europe begin with Germany in 2027. Source
  • Bivamelagon hyperphagia study in 2027: A 6-month hyperphagia study of bivamelagon in PWS is planned for 2027, pending alignment with the FDA. Source

Figures management reported

FigureReported
IMCIVREE net product revenue, global, Q3 2026 Source$92.1 million
IMCIVREE net product revenue, nine months 2026 Source$223.5 million
R&D expenses, Q3 2026 Source$52.5 million
Patient start forms, acquired HO Sourcemore than 700
Japan approval, acquired HO Sourceapproved August 24, 2026

Earlier plans management reported on

  • Not stated: Management restated the plan to start the pivotal trial by year-end 2026, the same timing as the prior release. Source
  • Not stated: Enrollment completion moved from the second half of 2026 in the prior release to 2027 in this release. Source
  • Not stated: Management kept the second half of 2026 timing for completing enrollment in the RM-718 PWS Part D trial. Source
  • Not stated: The prior release anticipated a Japan launch after a health ministry decision by year-end 2026; this release reports the launch was announced October 13, 2026. 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.