Rhythm Pharmaceuticals Reports Second Quarter 2025 Financial Results and Business Update
Rhythm Pharmaceuticals (NASDAQ:RYTM) reported strong Q2 2025 financial results, with IMCIVREE® global sales reaching $48.5 million, up 29% from Q1 2025. The company successfully raised $189.2 million through a public offering of common stock at $85 per share.
Key clinical achievements include positive Phase 2 results for bivamelagon and Phase 3 TRANSCEND trial data for setmelanotide in acquired hypothalamic obesity. The Phase 2 trial showed significant BMI reductions of 9.3% in the 600mg cohort and 7.7% in the 400mg cohort. The company plans to complete regulatory submissions for setmelanotide in acquired hypothalamic obesity to FDA and EMA in Q3 2025.
Q2 2025 resulted in a net loss of $48.0 million ($0.75 per share), compared to $33.6 million ($0.55 per share) in Q2 2024. The company projects $285-315 million in Non-GAAP Operating Expenses for 2025.
Rhythm Pharmaceuticals (NASDAQ:RYTM) ha riportato risultati finanziari solidi nel secondo trimestre del 2025, con le vendite globali di IMCIVREE® che hanno raggiunto i 48,5 milioni di dollari, in aumento del 29% rispetto al primo trimestre del 2025. L'azienda ha raccolto con successo 189,2 milioni di dollari attraverso un'offerta pubblica di azioni ordinarie a 85 dollari per azione.
Tra i principali traguardi clinici si segnalano risultati positivi di Fase 2 per il bivamelagon e dati della sperimentazione di Fase 3 TRANSCEND per setmelanotide nell'obesità ipotalamica acquisita. La sperimentazione di Fase 2 ha mostrato riduzioni significative dell'IMC pari al 9,3% nel gruppo da 600 mg e al 7,7% nel gruppo da 400 mg. L'azienda prevede di completare le presentazioni regolatorie per setmelanotide nell'obesità ipotalamica acquisita alla FDA e all'EMA nel terzo trimestre del 2025.
Il secondo trimestre del 2025 si è chiuso con una perdita netta di 48,0 milioni di dollari (0,75 dollari per azione), rispetto a 33,6 milioni di dollari (0,55 dollari per azione) nel secondo trimestre del 2024. L'azienda prevede spese operative Non-GAAP tra 285 e 315 milioni di dollari per il 2025.
Rhythm Pharmaceuticals (NASDAQ:RYTM) reportó sólidos resultados financieros en el segundo trimestre de 2025, con ventas globales de IMCIVREE® que alcanzaron los 48,5 millones de dólares, un aumento del 29% respecto al primer trimestre de 2025. La compañía recaudó con éxito 189,2 millones de dólares mediante una oferta pública de acciones ordinarias a 85 dólares por acción.
Los principales logros clínicos incluyen resultados positivos de Fase 2 para bivamelagon y datos del ensayo TRANSCEND de Fase 3 para setmelanotida en obesidad hipotalámica adquirida. El ensayo de Fase 2 mostró reducciones significativas del IMC del 9,3% en la cohorte de 600 mg y del 7,7% en la cohorte de 400 mg. La compañía planea completar las presentaciones regulatorias para setmelanotida en obesidad hipotalámica adquirida ante la FDA y EMA en el tercer trimestre de 2025.
El segundo trimestre de 2025 resultó en una pérdida neta de 48,0 millones de dólares (0,75 dólares por acción), comparado con 33,6 millones de dólares (0,55 dólares por acción) en el segundo trimestre de 2024. La compañía proyecta gastos operativos Non-GAAP entre 285 y 315 millones de dólares para 2025.
Rhythm Pharmaceuticals (NASDAQ:RYTM)은 2025년 2분기 강력한 재무 실적을 보고했으며, IMCIVREE® 글로벌 매출이 4,850만 달러로 2025년 1분기 대비 29% 증가했습니다. 회사는 보통주를 주당 85달러에 공개 발행하여 1억 8,920만 달러를 성공적으로 조달했습니다.
주요 임상 성과로는 bivamelagon의 2상 긍정적 결과와 후천성 시상하부 비만에 대한 setmelanotide의 3상 TRANSCEND 시험 데이터가 포함됩니다. 2상 시험에서는 600mg 군에서 9.3%, 400mg 군에서 7.7%의 BMI 유의미한 감소가 나타났습니다. 회사는 2025년 3분기에 FDA와 EMA에 후천성 시상하부 비만에 대한 setmelanotide 규제 제출을 완료할 계획입니다.
2025년 2분기 순손실은 4,800만 달러(주당 0.75달러)로, 2024년 2분기의 3,360만 달러(주당 0.55달러)와 비교됩니다. 회사는 2025년 비-GAAP 영업비용을 2억 8,500만~3억 1,500만 달러로 예상하고 있습니다.
Rhythm Pharmaceuticals (NASDAQ:RYTM) a annoncé de solides résultats financiers pour le deuxième trimestre 2025, avec des ventes mondiales d'IMCIVREE® atteignant 48,5 millions de dollars, en hausse de 29 % par rapport au premier trimestre 2025. La société a levé avec succès 189,2 millions de dollars grâce à une offre publique d'actions ordinaires à 85 dollars par action.
Les principales avancées cliniques incluent des résultats positifs de phase 2 pour le bivamelagon et des données de l'essai de phase 3 TRANSCEND pour le setmelanotide dans l'obésité hypothalamique acquise. L'essai de phase 2 a montré des réductions significatives de l'IMC de 9,3 % dans la cohorte à 600 mg et de 7,7 % dans la cohorte à 400 mg. La société prévoit de finaliser les soumissions réglementaires pour le setmelanotide dans l'obésité hypothalamique acquise auprès de la FDA et de l'EMA au troisième trimestre 2025.
Le deuxième trimestre 2025 s'est soldé par une perte nette de 48,0 millions de dollars (0,75 dollar par action), contre 33,6 millions de dollars (0,55 dollar par action) au deuxième trimestre 2024. La société prévoit des dépenses opérationnelles Non-GAAP comprises entre 285 et 315 millions de dollars pour 2025.
Rhythm Pharmaceuticals (NASDAQ:RYTM) meldete starke Finanzergebnisse für das zweite Quartal 2025, wobei die weltweiten IMCIVREE®-Verkäufe 48,5 Millionen US-Dollar erreichten, ein Anstieg von 29 % gegenüber dem ersten Quartal 2025. Das Unternehmen sammelte erfolgreich 189,2 Millionen US-Dollar durch ein öffentliches Angebot von Stammaktien zu je 85 US-Dollar ein.
Wichtige klinische Erfolge umfassen positive Phase-2-Ergebnisse für Bivamelagon sowie Daten der Phase-3-TRANSCEND-Studie für Setmelanotid bei erworbener hypothalamischer Adipositas. Die Phase-2-Studie zeigte signifikante BMI-Reduktionen von 9,3 % in der 600-mg-Kohorte und 7,7 % in der 400-mg-Kohorte. Das Unternehmen plant, die Zulassungsanträge für Setmelanotid bei erworbener hypothalamischer Adipositas im dritten Quartal 2025 bei FDA und EMA einzureichen.
Das zweite Quartal 2025 endete mit einem Nettoverlust von 48,0 Millionen US-Dollar (0,75 US-Dollar pro Aktie) im Vergleich zu 33,6 Millionen US-Dollar (0,55 US-Dollar pro Aktie) im zweiten Quartal 2024. Das Unternehmen prognostiziert Non-GAAP-Betriebskosten zwischen 285 und 315 Millionen US-Dollar für 2025.
- IMCIVREE global sales grew 29% quarter-over-quarter to $48.5 million
- Successfully raised $189.2 million through public offering
- Bivamelagon Phase 2 trial met primary endpoint with significant BMI reductions
- Strong Phase 3 TRANSCEND trial results showing 19.8% placebo-adjusted BMI reduction
- Cash runway extended to at least 24 months
- Net loss increased to $48.0 million in Q2 2025 from $33.6 million in Q2 2024
- SG&A expenses increased 26% year-over-year to $45.9 million
- R&D expenses rose 40% year-over-year to $42.3 million
- Other income turned to $1.0 million expense from $8.7 million income year-over-year
Insights
Rhythm's Q2 shows strong 29% sequential revenue growth with positive trial results for hypothalamic obesity treatments, significantly strengthening its market position.
Rhythm Pharmaceuticals delivered $48.5 million in Q2 2025 IMCIVREE revenue, representing impressive
The most significant clinical developments came from the hypothalamic obesity programs. Setmelanotide demonstrated a remarkable
From a financial perspective, R&D expenses increased to
The company's cash position of
Rhythm's setmelanotide and bivamelagon show clinically meaningful weight reductions in hypothalamic obesity, supporting potential breakthrough treatments for this rare condition.
The clinical data presented by Rhythm Pharmaceuticals this quarter represents potentially significant advancements for patients with hypothalamic obesity, a rare condition with limited treatment options. The Phase 3 TRANSCEND trial for setmelanotide delivered remarkable efficacy with a
The bivamelagon Phase 2 results further strengthen Rhythm's position in this therapeutic area, achieving statistically significant BMI reductions of
The company's development of weekly-administered RM-718 (enrolling first patients in Phase 1 Part C) indicates a strategic focus on improving patient convenience through less frequent dosing. Additionally, the real-world data presented at ESPE-ESE showing consistent improvements in BMI, BMI-Z, and hunger scores in 35 hypothalamic obesity patients treated with setmelanotide for up to nine months provides valuable supportive evidence beyond controlled trials.
With regulatory submissions for setmelanotide in acquired hypothalamic obesity on track for Q3 2025, additional readouts from the Prader-Willi syndrome trial in 2H 2025, and multiple other trial milestones through 2026, Rhythm is establishing a comprehensive clinical program addressing several rare neuroendocrine diseases with significant unmet needs. The consistency of clinical effects across trials and patient populations suggests their MC4R agonism platform has potential to transform treatment paradigms in these conditions.
-- Second quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of
-- U.S. and EU regulatory submissions for setmelanotide in acquired hypothalamic obesity on track to be completed in the third quarter of 2025 --
-- Bivamelagon Phase 2 trial met primary endpoint with statistically significant, clinically meaningful BMI reductions in patients with acquired hypothalamic obesity --
-- Raised approximately
-- Management to host conference call today at 8:00 a.m. ET --
BOSTON, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today reported financial results and provided a business update for the second quarter ended June 30, 2025.
“Rhythm has made significant progress in advancing our melanocortin-4 receptor agonism platform and executing on our global mission to transform the lives of patients with rare neuroendocrine diseases,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “This quarter, we presented strong Phase 2 and Phase 3 data that demonstrated the potential efficacy of both bivamelagon and setmelanotide, respectively, as treatment options for patients with acquired hypothalamic obesity.”
Dr. Meeker continued, “Global commercial sales of IMCIVREE achieved double-digit growth this quarter, and we also strengthened our balance sheet through an upsized common stock offering in July. We enter the second half of 2025 well-positioned to drive sustained growth and value for patients and shareholders by working to expand the reach of setmelanotide into additional rare MC4R pathway diseases and develop new therapeutic options designed to improve the patient experience.”
Second Quarter and Recent Business Highlights
- Revenue from global sales of IMCIVREE was
$48.5 million for the second quarter of 2025, an increase of29% percent on a sequential basis from the first quarter of 2025, primarily driven by sales of IMCIVREE for the treatment of patients with Bardet-Biedl syndrome (BBS). In the second quarter of 2025, revenue of$32.0 million , or66% of product revenue, was generated in the United States, an increase of31% on a sequential basis. Revenue of$16.5 million , or34% of product revenue, was generated outside the United States, a sequential increase of24% ; and - On July 11, 2025, Rhythm closed an upsized public offering of 2,367,647 shares of its common stock at a price of
$85 per share, resulting in net proceeds of approximately$189.2 million , net of underwriting discounts and commissions, but excluding certain other offering expenses payable by the Company.
Second Quarter and Recent Clinical Development Highlights
- Today, Rhythm announced that it has enrolled the first patient with hypothalamic obesity in Part C of its Phase 1 trial evaluating RM-718, a weekly-administered melanocortin-4 receptor (MC4R) agonist;
- On July 12, 2025, at the Endocrine Society’s Annual Meeting, data from the Company’s pivotal Phase 3 TRANSCEND trial evaluating setmelanotide in acquired hypothalamic obesity, the largest randomized, placebo-controlled trial in acquired hypothalamic obesity to date, were delivered in an oral presentation. Highlights of the presentation included:
- -
19.8% placebo-adjusted difference in BMI reduction (N=120); and - Statistically significant BMI reductions following setmelanotide treatment were consistently observed across subgroups stratified by age (<12, 12 to 17, <18, and 18 years and older; ranging from -
15.6% to -17.2% ) and by sex (-16.3% female; -16.8% male);
- -
- On July 9, 2025, Rhythm announced bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment in its Phase 2 trial in patients with acquired hypothalamic obesity, including;
- -
9.3% BMI reduction from baseline in the 600mg cohort (n=8) (p-value=0.0004); - -
7.7% BMI reduction from baseline in the 400mg cohort (n=7) (p-value=0.0002); - Post-hoc analyses showing bivamelagon demonstrated BMI reductions consistent with BMI reductions achieved with setmelanotide therapy as observed in similar patient populations at comparable dosing durations; and
- Safety and tolerability results were consistent with MC4R agonism and mechanism of action during the placebo-controlled portion of the trial; and
- -
- During the Joint Congress between the European Society for Paediatric Endocrinology and the European Society of Endocrinology (ESPE-ESE) and the European Congress on Obesity (ECO) in May 2025, Rhythm presented new, real-world data that showed consistent improvements in body mass index, BMI-Z, and hunger scores in 30 patients with acquired hypothalamic obesity and five (5) patients with congenital hypothalamic obesity who were treated with setmelanotide for up to nine months.
Anticipated Upcoming Milestones
Rhythm expects to achieve the following near-term milestones:
- Complete submissions of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) and a Type II variation request to the European Medicines Agency seeking approval for setmelanotide for the treatment of acquired hypothalamic obesity in the third quarter of 2025;
- Disclose preliminary results from the Company’s setmelanotide Phase 2 trial in Prader-Willi syndrome in the second half of 2025;
- Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired hypothalamic obesity in the first quarter of 2026;
- Announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired hypothalamic obesity in the first quarter of 2026;
- Announce topline data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026;
- Complete enrollment in the setmelanotide Phase 3 trial substudy in congenital hypothalamic obesity in the first half of 2026; and
- Pending alignment with U.S and European regulatory agencies, initiate a pivotal Phase 3 trial evaluating bivamelagon in acquired hypothalamic obesity in 2026.
In addition, Rhythm announced today that it plans to host “Commercial Readiness for Acquired Hypothalamic Obesity”, an in-person and webcasted event for investors and analysts, on September 24, 2025, in Boston to review its global launch strategy for setmelanotide. The event will also feature insights from leading physicians about the urgent need to treat patients with acquired hypothalamic obesity. Registration details will follow.
Second Quarter 2025 Financial Results:
Cash Position: As of June 30, 2025, cash, cash equivalents and short-term investments were approximately
Revenue: Net product revenues relating to global sales of IMCIVREE were
R&D Expenses: R&D expenses were
SG&A Expenses: SG&A expenses were
Other income (expense), net: Other income (expense), net was (
Net Loss: Net loss attributable to common stockholders was (
Year to Date 2025 Financial Results:
Revenue: Net product revenues relating to sales of IMCIVREE were
R&D Expenses: R&D expenses were
SG&A Expenses: SG&A expenses were
Other income (expense), net: Other income (expense), net was (
Net Loss: Net loss attributable to common stockholders was (
Financial Guidance: For the year ending December 31, 2025, Rhythm anticipates approximately
- GAAP total operating expenses, inclusive of:
- SG&A expenses of approximately
$135 million to$145 million ; - R&D expenses of approximately
$150 million to$170 million ; and - Excluding stock-based compensation.
- SG&A expenses of approximately
Non-GAAP Operating Expenses is defined as GAAP operating expenses excluding stock-based compensation and fixed consideration related to in-licensing (see below under "Non-GAAP Financial Measures" for more details).
Based on its current operating plans, Rhythm expects that its cash, cash equivalents and short-term investments as of June 30, 2025, combined with the net proceeds from the July 2025 offering, will be sufficient to fund the Company’s planned operations for at least 24 months.
Conference Call Information
Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET today to review its second quarter 2025 financial results and recent business activities. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start.
A webcast of the call will also be available under "Events and Presentations" in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call.
About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the FDA to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.
Setmelanotide Indication
In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.
Limitations of Use
Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:
- Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
- Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity
Contraindication
Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.
Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.
Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs.
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥
USE IN SPECIFIC POPULATIONS
Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.
Please see the full Prescribing Information for additional Important Safety Information.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the safety, efficacy, potential benefits of, and clinical design or progress of any of our products or product candidates at any dosage or in any indication, including, setmelanotide, bivamelagon, and RM-718; the potential use of setmelanotide in patients with acquired hypothalamic obesity; the commercial growth of IMCIVREE; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product candidates, including the anticipated supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency; the estimated market size and addressable population for our drug products, including setmelanotide for the treatment of hypothalamic obesity; the future announcement of data from our ongoing clinical trials, including the Japanese cohort of our Phase 3 trial evaluating setmelanotide for patients with acquired hypothalamic obesity, the substudy evaluating setmelanotide for patients with congenital hypothalamic obesity, the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases; Part C of the Phase 1 trial evaluating RM-718, and the open-label Phase 2 trial evaluating setmelanotide in patients with Prader-Willi syndrome; the ongoing enrollment in our clinical trials; the Company’s business strategy and plans; our anticipated financial performance and financial position for any period of time, including estimated Non-GAAP Operating Expenses for the year ending December 31, 2025; the sufficiency of our cash, cash equivalents and short-term investments to fund our operations; and the timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors, including those discussed under the caption “Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the three months ended June 30, 2025 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this press release or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise.
Non-GAAP Financial Measures
This press release includes Non-GAAP Operating Expenses, a supplemental measure of our performance that is not required by, or presented in accordance with, U.S. GAAP and should not be considered as an alternative to operating expenses or any other performance measure derived in accordance with GAAP.
We define Non-GAAP Operating Expenses as GAAP operating expenses excluding stock-based compensation and fixed consideration related to in-licensing.
We caution investors that amounts presented in accordance with our definition of Non-GAAP Operating Expenses may not be comparable to similar measures disclosed by our competitors because not all companies and analysts calculate this non-GAAP financial measure in the same manner. We present this non-GAAP financial measure because we consider it to be an important supplemental measure of our performance and believe it is frequently used by securities analysts, investors, and other interested parties in the evaluation of companies in our industry. Management believes that investors’ understanding of our performance is enhanced by including this non-GAAP financial measure as a reasonable basis for comparing our ongoing results of operations.
Management uses this non-GAAP financial measure for planning purposes, including the preparation of our internal annual operating budget and financial projections; to evaluate the performance and effectiveness of our operational strategies; and to evaluate our capacity to expand our business. This non-GAAP financial measure has limitations as an analytical tool, and should not be considered in isolation, or as an alternative to, or a substitute for operating expenses or other financial statement data presented in accordance with GAAP in our consolidated financial statements.
Rhythm has not provided a quantitative reconciliation of forecasted Non-GAAP Operating Expenses to forecasted GAAP operating expenses because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence. This item, which could materially affect the computation of forward-looking GAAP operating expenses, is inherently uncertain and depends on various factors, some of which are outside of Rhythm's control.
Corporate Contact:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com
Media Contact:
Layne Litsinger
Real Chemistry
410-916-1035
llitsinger@realchemistry.com
| Rhythm Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited) | |||||||||||||||
| Three months ended June 30, | Six months ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenues: | |||||||||||||||
| Product revenue, net | $ | 48,502 | $ | 29,078 | $ | 86,220 | $ | 55,045 | |||||||
| License revenue | — | — | (5,014 | ) | — | ||||||||||
| Total revenues | 48,502 | 29,078 | 81,206 | 55,045 | |||||||||||
| Costs and expenses: | |||||||||||||||
| Cost of sales | 5,543 | 2,947 | 9,191 | 5,753 | |||||||||||
| Research and development | 42,308 | 30,194 | 79,281 | 158,858 | |||||||||||
| Selling, general, and administrative | 45,947 | 36,415 | 85,034 | 70,797 | |||||||||||
| Total costs and expenses | 93,798 | 69,556 | 173,506 | 235,408 | |||||||||||
| Loss from operations | (45,296 | ) | (40,478 | ) | (92,300 | ) | (180,363 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Other income (expense), net | 1,576 | 302 | 932 | 824 | |||||||||||
| Gain on settlement of forward contract | — | 8,900 | — | 8,900 | |||||||||||
| Interest expense | (5,817 | ) | (4,603 | ) | (11,226 | ) | (9,358 | ) | |||||||
| Interest income | 3,242 | 4,097 | 6,881 | 7,143 | |||||||||||
| Total other (expense), net | (999 | ) | 8,696 | (3,413 | ) | 7,509 | |||||||||
| Loss before income taxes | (46,295 | ) | (31,782 | ) | (95,713 | ) | (172,854 | ) | |||||||
| Provision for income taxes | 337 | 479 | 417 | 779 | |||||||||||
| Net loss | $ | (46,632 | ) | $ | (32,261 | ) | $ | (96,130 | ) | $ | (173,633 | ) | |||
| Accrued dividends on convertible preferred stock | (1,349 | ) | (1,302 | ) | (2,671 | ) | (1,302 | ) | |||||||
| Net loss attributable to common stockholders | $ | (47,981 | ) | $ | (33,563 | ) | $ | (98,801 | ) | $ | (174,935 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.75 | ) | $ | (0.55 | ) | $ | (1.56 | ) | $ | (2.89 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 63,684,359 | 61,011,824 | 63,373,489 | 60,577,691 | |||||||||||
| Other comprehensive loss: | |||||||||||||||
| Net loss attributable to common stockholders | $ | (47,981 | ) | $ | (33,563 | ) | $ | (98,801 | ) | $ | (174,935 | ) | |||
| Foreign currency translation adjustment | (2,104 | ) | (302 | ) | (2,106 | ) | (373 | ) | |||||||
| Unrealized (loss), net on marketable securities | (93 | ) | (134 | ) | (103 | ) | (378 | ) | |||||||
| Comprehensive loss | $ | (50,178 | ) | $ | (33,999 | ) | $ | (101,010 | ) | $ | (175,686 | ) | |||
| Rhythm Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited) | ||||||||
| June 30, 2025 | Dec. 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 135,586 | $ | 89,137 | ||||
| Short-term investments | 155,444 | 231,428 | ||||||
| Accounts receivable, net | 26,122 | 18,512 | ||||||
| Inventory | 18,872 | 18,741 | ||||||
| Prepaid expenses and other current assets | 24,656 | 16,382 | ||||||
| Total current assets | 360,680 | 374,200 | ||||||
| Property and equipment, net | 297 | 632 | ||||||
| Right-of-use asset | 3,262 | 3,477 | ||||||
| Intangible assets, net | 5,747 | 6,174 | ||||||
| Restricted cash | 527 | 464 | ||||||
| Other long-term assets | 2,220 | 7,326 | ||||||
| Total assets | $ | 372,733 | $ | 392,273 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 15,982 | $ | 12,328 | ||||
| Accrued expenses and other current liabilities | 69,185 | 62,658 | ||||||
| Other current liability - LG Chem | 40,000 | 37,704 | ||||||
| Lease liability | 510 | — | ||||||
| Deferred revenue | — | 1,286 | ||||||
| Deferred royalty obligation, current | 3,778 | 1,541 | ||||||
| Total current liabilities | 129,455 | 115,517 | ||||||
| Long-term liabilities: | ||||||||
| Deferred royalty obligation | 106,014 | 108,269 | ||||||
| Lease liability, non-current | 3,681 | 3,938 | ||||||
| Total liabilities | 239,150 | 227,724 | ||||||
| Commitments and contingencies (Note 13) | ||||||||
| Series A convertible preferred stock, | 145,491 | 142,820 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 64 | 61 | ||||||
| Additional paid-in capital | 1,241,744 | 1,177,045 | ||||||
| Accumulated other comprehensive (loss) | (2,248 | ) | (39 | ) | ||||
| Accumulated deficit | (1,251,468 | ) | (1,155,338 | ) | ||||
| Total stockholders’ equity | (11,908 | ) | 21,729 | |||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 372,733 | $ | 392,273 | ||||
FAQ
What were Rhythm Pharmaceuticals (RYTM) Q2 2025 earnings results?
How much did Rhythm Pharmaceuticals raise in their July 2025 stock offering?
What were the Phase 2 trial results for RYTM's bivamelagon in hypothalamic obesity?
What is RYTM's cash position and financial outlook for 2025?
When will Rhythm submit regulatory applications for setmelanotide in hypothalamic obesity?
