Financial Data and Key Metrics Changes - Rhythm Pharmaceuticals reported global revenue of $51.3 million for Q3 2025, a sequential increase of 6% from $48.5 million in Q2 2025 [28] - The number of patients on reimbursed therapy increased by 10% globally during the quarter [28] - Year-over-year, net product revenues increased by $18 million, or 54%, compared to Q3 2024 [32] Business Line Data and Key Metrics Changes - InSibiri sales reached $51.3 million, driven predominantly by Bardet-Biedl Syndrome (BBS), with a 10% increase in the number of patients on reimbursed therapy [4][28] - The proportion of prescriptions for pediatric versus adult patients began to normalize, with 50% of new patients being adults, 22% adolescents, and 28% pediatrics [16] Market Data and Key Metrics Changes - In the U.S., $38.2 million or 74% of Q3 net revenue was generated, while $13.1 million or 26% came from international markets [28] - International revenue decreased by $3.4 million quarter-over-quarter, but patients on reimbursed therapy increased at a low double-digit percentage [30] Company Strategy and Development Direction - The company is preparing for the launch of InSibiri for hypothalamic obesity, pending FDA approval, with a PDUFA date set for December 20, 2025 [5][11] - Rhythm is focused on engaging with physicians and payers to establish InSibiri as a foundational treatment for acquired hypothalamic obesity [20] - The company aims to complete enrollment of the RM-718 weekly phase 2 study in HO patients during Q1 2026 and initiate a phase 3 study with Bivamelagon next year [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of InSibiri for hypothalamic obesity, highlighting strong growth in BBS and promising regulatory dialogues [5][11] - The company anticipates that the upcoming data readouts and regulatory approvals will position it for sustained long-term growth [4][5] Other Important Information - Rhythm raised approximately $189 million in net proceeds from a follow-on equity offering completed in July 2025, ending Q3 with $416.1 million in cash [28] - The company expects to have sufficient cash to fund planned operations for at least 24 months [34] Q&A Session Summary Question: Can you share your latest thinking on the trial design for your phase 3 HO study? - The HO trial will be a double-blind randomized controlled trial, with expectations for a full year of data [39] Question: Can you provide more details on the efficacy endpoints for Prader-Willi syndrome? - Success will be defined by a BMI percent change, with a target of a 5% threshold in BMI decrease in 52 weeks [45] Question: What are the drivers behind the changes to the ongoing Prader-Willi trial? - The trial was extended to allow patients to continue beyond the initial six months if they wish, and there is a possibility of adding additional sites [51] Question: How should investors think about the launch curve in hypothalamic obesity? - The company has a solid foundation based on learnings from the BBS launch, but the process of getting patients diagnosed may take time [60][62] Question: What is the anticipated gross to net in HO relative to BBS? - The gross to net mix is uncertain, but the company expects to work through reimbursement processes similar to those for BBS [66]

Financial Performance & Guidance - Rhythm Pharmaceuticals reported Q3 2025 product revenue of $51.3 million, compared to $33.3 million in Q3 2024[51] - The company experienced a 10% quarter-over-quarter growth in patients on reimbursed therapy globally[49] - Q3 2025 operating expenses totaled $98.5 million, including $18.8 million in stock-based compensation expense[52] - Rhythm anticipates non-GAAP operating expenses for 2025 to be between $295 million and $315 million, including R&D expenses of $150 million to $165 million and SG&A expenses of $145 million to $150 million[52] - As of September 30, 2025, Rhythm Pharmaceuticals held $416.1 million in cash, cash equivalents, and short-term investments[51] IMCIVREE & Pipeline Updates - Steady growth in global IMCIVREE sales in Q3 2025 was primarily driven by Bardet-Biedl syndrome (BBS)[10] - The FDA accepted the sNDA for setmelanotide in acquired hypothalamic obesity (HO) for Priority Review, with a PDUFA goal date of December 20, 2025[10] - A German investigator-led study showed that over 80% of BBS patients on setmelanotide exhibited either resolution of MASLD or stabilization at grade S1 after six months of therapy[12] - The same study showed 100% of patients (N=26) with both BBS and metabolic dysfunction-associated steatotic liver disease (MASLD) showed improvement[12] Strategic Initiatives & Market Access - Rhythm Pharmaceuticals estimates the U S prevalence of acquired hypothalamic obesity to be approximately 10,000 patients[15] - IMCIVREE is available in >25 countries outside the United States[36] - Rhythm estimates the European prevalence of acquired hypothalamic obesity to be approximately 10,000 patients[40] - Rhythm estimates the prevalence of acquired hypothalamic obesity in Japan to be approximately 5,000 to 8,000[43]

Revenue Performance - Third quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) was $51.3 million, representing a 6% increase sequentially from the second quarter of 2025[3]. - Revenue generated in the United States was $38.2 million, accounting for 74% of product revenue, with a 19% sequential increase[3]. - Revenue from outside the United States was $13.1 million, a decrease of $3.4 million or 21% sequentially[3]. - Product revenue for Q3 2025 reached $51.298 million, a 54% increase from $33.251 million in Q3 2024[41]. - Total revenues for the nine months ended September 30, 2025, were $132.504 million, compared to $88.296 million for the same period in 2024, reflecting a 50% year-over-year growth[41]. Expenses and Losses - R&D expenses for the third quarter of 2025 were $46.0 million, up from $37.9 million in the same quarter of 2024[8]. - SG&A expenses increased to $52.4 million in the third quarter of 2025, compared to $35.4 million in the third quarter of 2024[9]. - Net loss attributable to common stockholders for the third quarter of 2025 was ($54.3) million, or ($0.82) per share, compared to a net loss of ($45.0) million, or ($0.73) per share, in the same quarter of 2024[10]. - The net loss for Q3 2025 was $52.904 million, compared to a net loss of $43.641 million in Q3 2024, representing a 21% increase in losses[41]. - The company reported a net loss per share of $0.82 for Q3 2025, compared to $0.73 for Q3 2024[41]. Financial Position - Cash, cash equivalents, and short-term investments as of September 30, 2025, were approximately $416.1 million, up from $320.6 million as of December 31, 2024[6]. - Total assets increased to $506,874,000 as of September 30, 2025, up from $392,273,000 on December 31, 2024, representing a growth of 29.1%[42]. - Current assets rose to $494,802,000, compared to $374,200,000 at the end of 2024, marking a 32.2% increase[42]. - Cash and cash equivalents decreased to $52,078,000 from $89,137,000, a decline of 41.6%[42]. - Short-term investments increased significantly to $363,974,000, up from $231,428,000, reflecting a growth of 57.1%[42]. - Total current liabilities decreased to $104,267,000 from $115,517,000, a reduction of 9.8%[42]. - Stockholders' equity surged to $148,817,000, compared to $21,729,000 at the end of 2024, an increase of 584.5%[42]. - The accumulated deficit widened to $(1,304,372,000) from $(1,155,338,000), indicating a decrease in retained earnings[42]. - Accounts receivable increased to $33,034,000 from $18,512,000, a rise of 78.5%[42]. - Inventory levels rose to $22,107,000, compared to $18,741,000, an increase of 17.5%[42]. - Additional paid-in capital increased to $1,454,048,000 from $1,177,045,000, reflecting a growth of 23.5%[42]. Future Outlook - The company anticipates Non-GAAP Operating Expenses for the year ending December 31, 2025, to be approximately $295 million to $315 million[17]. - The company anticipates Non-GAAP Operating Expenses for the year ending December 31, 2025, to be a key focus for financial performance evaluation[36]. - Rhythm expects to report preliminary results from the setmelanotide Phase 2 trial in Prader-Willi syndrome in the fourth quarter of 2025[1]. - The FDA has set a PDUFA goal date of December 20, 2025, for the supplemental new drug application for setmelanotide in acquired hypothalamic obesity[1]. - Rhythm Pharmaceuticals is actively pursuing regulatory submissions and anticipates future announcements regarding ongoing clinical trials[35]. - The company is focused on expanding its market presence and enhancing its product pipeline, particularly with setmelanotide for hypothalamic obesity[35].

Core Insights - Rhythm Pharmaceuticals reported continued momentum in the third quarter of 2025, highlighted by FDA acceptance of the supplemental new drug application (sNDA) for acquired hypothalamic obesity and steady growth from Bardet-Biedl syndrome (BBS) commercial efforts [2][5] Financial Performance - Revenue from global sales of IMCIVREE (setmelanotide) was $51.3 million for Q3 2025, a 6% increase from Q2 2025, primarily driven by growth in patients and sales for BBS treatment [3][9] - U.S. revenue accounted for $38.2 million (74% of product revenue), marking a 19% sequential increase, while international revenue was $13.1 million (26% of product revenue), reflecting a 21% decrease [3][9] - The company recorded a one-time charge of $3.2 million in Q3 2025 due to a final reimbursed price agreement for IMCIVREE in France [3][9] - R&D expenses were $46.0 million in Q3 2025, up from $37.9 million in Q3 2024, mainly due to increased headcount and stock-based compensation [10] - SG&A expenses rose to $52.4 million in Q3 2025 from $35.4 million in Q3 2024, driven by higher costs associated with expanding operations and marketing [11] - The net loss attributable to common stockholders was $54.3 million for Q3 2025, compared to a net loss of $45.0 million in Q3 2024 [12] Clinical Developments - Rhythm expects to report preliminary results from the Phase 2 trial of setmelanotide in Prader-Willi syndrome in Q4 2025 [5][13] - A recent observational study indicated that setmelanotide treatment improved measures of metabolic dysfunction-associated steatotic liver disease (MASLD) and kidney function in BBS patients [6][7] Upcoming Milestones - The FDA's PDUFA goal date for the sNDA for setmelanotide in acquired hypothalamic obesity is set for December 20, 2025 [5][7] - The company anticipates completing enrollment in the Phase 1 trial evaluating RM-718 in Q1 2026 and announcing topline data from various ongoing trials in early 2026 [13] Cash Position - As of September 30, 2025, the company had approximately $416.1 million in cash, cash equivalents, and short-term investments, compared to $320.6 million at the end of 2024 [8][20]

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Core Insights - Rhythm Pharmaceuticals, Inc. (RYTM) is expected to report a year-over-year increase in earnings driven by higher revenues for the quarter ended September 2025, with a consensus outlook indicating a quarterly loss of $0.72 per share, reflecting a +1.4% change from the previous year, and revenues projected at $50.24 million, up 51.1% from the year-ago quarter [1][3] Earnings Expectations - The earnings report is anticipated to be released on November 4, and if the actual results exceed expectations, the stock may experience upward movement; conversely, a miss could lead to a decline [2] - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4] Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that the Most Accurate Estimate for Rhythm Pharmaceuticals is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +9.24%, indicating a bullish sentiment among analysts [11] - A positive Earnings ESP is a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1 (Strong Buy), 2 (Buy), or 3 (Hold) [9] Historical Performance - In the last reported quarter, Rhythm Pharmaceuticals was expected to post a loss of $0.66 per share but actually reported a loss of -$0.75, resulting in a surprise of -13.64% [12] - Over the past four quarters, the company has only beaten consensus EPS estimates once [13] Conclusion - Rhythm Pharmaceuticals is viewed as a compelling candidate for an earnings beat, but investors should consider other factors influencing stock performance beyond just earnings results [16]

Core Viewpoint - Rhythm Pharmaceuticals, Inc. is set to report its third quarter 2025 financial results and provide a corporate update on November 4, 2025, at 8:00 a.m. ET [1] Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases [3] - The company's lead product, IMCIVREE® (setmelanotide), is an MC4R agonist approved by the FDA for treating obesity related to specific genetic conditions [3][4] - Setmelanotide is indicated for patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or deficiencies in POMC, PCSK1, or LEPR [4][5] Upcoming Events - Rhythm will host a live conference call and webcast for its financial results on November 4, 2025 [1] - The company will also participate in two fireside chats on November 12, 2025, at the Guggenheim Healthcare Innovation Conference and the Stifel Healthcare Conference [7] Product Indications - In the U.S., setmelanotide is indicated for long-term weight reduction in patients with specific genetic obesity conditions [4] - In the EU and UK, it is indicated for obesity treatment and hunger control associated with genetically confirmed BBS or related deficiencies [5] Limitations and Contraindications - Setmelanotide is not indicated for obesity due to benign variants of POMC, PCSK1, or LEPR [6][8] - Serious hypersensitivity reactions have been reported, contraindicating its use in patients with prior serious hypersensitivity to the drug [9] Warnings and Precautions - Patients may experience disturbances in sexual arousal, depression, and hypersensitivity reactions [10][11][12] - Skin hyperpigmentation and the development of new melanocytic nevi have been observed, necessitating regular skin examinations [13] Adverse Reactions - Common adverse reactions (≥20% incidence) include skin hyperpigmentation, injection site reactions, nausea, headache, and depression [15]

Core Insights - ClearBridge Investments reported a modest underperformance of its "ClearBridge Small Cap Growth Strategy" compared to the Russell 2000 Growth Index in Q2 2025, as the market rally favored lower market capitalization and riskier stocks [1] - Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) showed a one-month return of -4.79% but a significant 95.91% increase over the last 52 weeks, with a market capitalization of $6.458 billion as of October 2, 2025 [2][3] Company Overview - Rhythm Pharmaceuticals, Inc. focuses on metabolic conditions related to genetic and injury-related obesity, with its main product launched in several rare indications and potential for broader market approval soon [3] - The company has a pipeline of candidates aimed at enhancing lifecycle management and addressing related illnesses, indicating robust growth potential [3] Hedge Fund Interest - Rhythm Pharmaceuticals, Inc. was held by 40 hedge fund portfolios at the end of Q2 2025, a decrease from 47 in the previous quarter, suggesting a decline in popularity among hedge funds [4] - Despite acknowledging the potential of Rhythm Pharmaceuticals, the company is viewed as having less upside compared to certain AI stocks, which are considered to carry less downside risk [4]

Core Insights - Rhythm Pharmaceuticals (NASDAQ: RYTM) has experienced a significant price increase of approximately 52% since the previous article, indicating strong market performance and investor interest [1]. Company Overview - Rhythm Pharmaceuticals is recognized as a pioneer in the field of rare genetic obesity, suggesting a unique market position and potential for growth in a specialized healthcare niche [1]. Investment Perspective - The author expresses a long-term beneficial position in Rhythm Pharmaceuticals, indicating confidence in the company's future performance and potential for continued investment success [2].

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