Rhythm Pharmaceuticals Q2 Earnings Call Highlights

Key Points

• IMCIVREE sales rose 19% sequentially to $71.3 million in Q2 2026, supported by early demand following its U.S. launch for acquired hypothalamic obesity. Rhythm received more than 400 start forms from roughly 300 prescribers during the first 14 weeks.
• Preliminary RM-718 Phase II data showed a mean 11.6% BMI reduction at 16 weeks among seven evaluable acquired-HO patients, although injection-site reactions and nausea led to two early discontinuations.
• Rhythm ended June with approximately $331 million in cash and short-term investments, which it expects to fund operations for at least 24 months. The company is planning a bivamelagon Phase III trial, additional RM-718 development in Prader-Willi syndrome, and international IMCIVREE launches beginning in Japan by year-end 2026.

Rhythm Pharmaceuticals NASDAQ: RYTM reported second-quarter 2026 global net product sales of $71.3 million for IMCIVREE, up 19% sequentially from $60.1 million in the first quarter, as the company cited an early positive reception to its U.S. launch in acquired hypothalamic obesity, or HO.

Chief Executive Officer David Meeker said the launch of IMCIVREE for acquired HO, approved by the FDA on March 19, represented the company’s next phase of growth. He also highlighted preliminary Phase II data for RM-718, a weekly MC4R agonist, as well as ongoing preparations for further international launches and potential development in Prader-Willi syndrome.

Early U.S. HO Launch Metrics

During the first 14 weeks following approval through June 30, Rhythm received more than 400 IMCIVREE start forms for acquired HO from approximately 300 unique prescribers. The total included 66 forms for converted clinical-trial participants, representing nearly all U.S. trial patients, according to Jennifer Lee, executive vice president and head of North America.

Lee said early prescriptions reflected a mix of incident and prevalent patients. Based on the company’s internal review of a portion of the prescriptions, about 15% of patients had sustained the injury associated with acquired HO within the past two years, while approximately half had experienced the injury more than 10 years ago.

Prescriber engagement was led by endocrinologists. Adult endocrinologists accounted for 43% of prescribers and pediatric endocrinologists represented 37%. About 20% of physicians had prescribed IMCIVREE for more than one acquired HO patient.

The company said 65% of its priority accounts had been activated by the end of June, and those accounts generated nearly 25% of prescriptions. Rhythm has identified approximately 43 priority accounts, which Lee described as centers where patients with brain tumors receive care before and after surgery and management for hypothalamic dysfunction.

On access, Rhythm said it had secured positive acquired HO coverage policies representing approximately 25% of Medicaid-covered lives and 35% of commercial covered lives by quarter-end. Lee said the company expects more policies to be established within three to nine months following approval.

Rhythm also noted that approximately half of prescribed acquired HO patients had prior or current experience with GLP-1 therapies, while about 25% remained on a GLP-1. The company said none of the acquired HO-specific payer policies in place required patients to try a GLP-1 before IMCIVREE.

Revenue, Expenses and Cash Position

U.S. product revenue totaled $51 million, or 72% of second-quarter product sales. Chief Financial Officer Hunter Smith said U.S. revenue growth was driven by increased demand in both acquired HO and Bardet-Biedl syndrome, or BBS. More than half of the $11.3 million sequential U.S. revenue increase came from the acquired HO launch.

International revenue declined to $20.3 million from $23.2 million in the first quarter. Smith attributed the decline primarily to a $3.8 million retrospective charge associated with France’s Contribution M mechanism, including $2.3 million related to 2025 revenue. Excluding that charge, he said the international business continued to add patients on reimbursed therapy.

• Research and development expense was $43.4 million, compared with $42.3 million a year earlier.
• Selling, general and administrative expense was $67.4 million, compared with $45.9 million in the prior-year period.
• GAAP net loss was $0.73 per basic and diluted share, including $0.02 per share from accrued dividends on convertible preferred stock.
• Cash used in operations was approximately $9 million.
• Cash equivalents and short-term investments totaled approximately $331 million at June 30.

The company said its cash resources are expected to fund planned operations for at least 24 months. Rhythm lowered the midpoint of its 2026 non-GAAP R&D expense outlook by $20 million because certain chemistry, manufacturing and controls activities for RM-718 and bivamelagon shifted from late 2026 to early 2027. It now expects total non-GAAP operating expenses of $363 million to $397 million for the year, including R&D expense of $175 million to $195 million and SG&A expense of $188 million to $202 million.

RM-718 Data and Pipeline Plans

Rhythm released preliminary results from Part C of an open-label Phase II trial of RM-718 in acquired HO. Of 11 enrolled patients, seven had reached the 16-week time point and showed a mean BMI reduction of 11.6%. The company compared that result with a 10.1% BMI reduction at week 16 in a pooled setmelanotide analysis and a 10.1% reduction at week 14 for bivamelagon at a 600-milligram dose.

Eight patients remained on active RM-718 therapy. Two patients discontinued during the first four weeks because of adverse events: one due to injection-site reactions and one due to nausea that continued despite dose reductions. A third patient completed the 16-week trial period but later withdrew from the long-term extension for personal reasons.

Meeker said RM-718 was generally well tolerated, with injection-site reactions and nausea as the most common adverse events. The company reported no generalized hyperpigmentation with either RM-718 or bivamelagon, which it said supports their greater specificity for the MC4R receptor relative to setmelanotide.

Rhythm plans to complete enrollment of 10 to 15 Prader-Willi syndrome patients in Part D of the open-label RM-718 study by the end of 2026. The company is also targeting initiation of a Phase III trial of bivamelagon in acquired HO by year-end. Initial enrollment will include patients age 12 and older while the company finalizes manufacturing work for orally dissolvable tablets during the first quarter of 2027.

International Expansion

In Japan, Rhythm expects marketing authorization for IMCIVREE in acquired HO and a commercial launch by the end of 2026. Yann Mazabraud, executive vice president and head of international, said the company expects to begin pricing discussions with Japan’s National Health Insurance Authority after receiving authorization from the Ministry of Health, Labour and Welfare. Rhythm estimates there are approximately 5,000 to 8,000 people with acquired HO in Japan.

In Europe, the European Commission granted marketing authorization for IMCIVREE in acquired HO in May. Rhythm expects to launch in Germany in the first half of 2027, subject to securing an exemption from the German Federal Joint Committee’s Annex II exclusion list. The company has also submitted dossiers to begin pricing discussions in France, the U.K., Italy, Spain and the Netherlands, with launches in those markets anticipated in 2027 following Germany.

Rhythm said it continues to see growth opportunities in BBS and has reorganized its North American field organization. Its 42 territory managers are now dedicated to acquired HO, while a separate BBS-focused territory manager group is expected to grow to 10 managers.

About Rhythm Pharmaceuticals (NASDAQ:RYTM)

Rhythm Pharmaceuticals, Inc is a clinical‐stage biotechnology company dedicated to developing targeted therapies for rare genetic diseases of obesity and metabolic dysfunction. The company's research focuses on the melanocortin‐4 receptor (MC4R) pathway, which plays a central role in regulating appetite, energy expenditure and body weight. Using proprietary peptide technology, Rhythm aims to provide precision treatments to patients with specific genetic variants that disrupt normal weight regulation.

The company's lead investigational product, setmelanotide, is a selective MC4R agonist designed to restore signaling in patients with deficiencies in genes such as POMC, LEPR and PCSK1.

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