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Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Business Update

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Rhythm Pharmaceuticals (RYTM) reported Q4 2024 global sales of $41.8 million for IMCIVREE, up 26% from Q3 2024. Full-year 2024 revenue reached $130.1 million, compared to $77.4 million in 2023.

Key developments include FDA approval for IMCIVREE's expanded label to treat children as young as 2 years old, and completion of enrollment in the Phase 2 trial of oral MC4R agonist bivamelagon. The company raised $75 million through ATM equity offering, extending cash runway into 2027.

Financial results show Q4 2024 net loss of $44.6 million ($0.72 per share). R&D expenses increased to $238.0 million for 2024, while SG&A expenses reached $144.3 million. Cash position as of December 31, 2024, was $320.6 million.

Rhythm Pharmaceuticals (RYTM) ha riportato vendite globali nel Q4 2024 di $41.8 milioni per IMCIVREE, in aumento del 26% rispetto al Q3 2024. Il fatturato totale per l'anno 2024 ha raggiunto $130.1 milioni, rispetto ai $77.4 milioni del 2023.

Sviluppi chiave includono l'approvazione da parte della FDA per l'etichetta ampliata di IMCIVREE, che consente il trattamento di bambini a partire dai 2 anni, e il completamento dell'arruolamento nella fase 2 della sperimentazione clinica del bivamelagon, un agonista orale dell'MC4R. L'azienda ha raccolto $75 milioni tramite un'offerta di equity ATM, estendendo la disponibilità di liquidità fino al 2027.

I risultati finanziari mostrano una perdita netta nel Q4 2024 di $44.6 milioni ($0.72 per azione). Le spese per R&D sono aumentate a $238.0 milioni per il 2024, mentre le spese SG&A hanno raggiunto $144.3 milioni. La posizione di cassa al 31 dicembre 2024 era di $320.6 milioni.

Rhythm Pharmaceuticals (RYTM) reportó ventas globales de $41.8 millones en el Q4 2024 para IMCIVREE, un aumento del 26% en comparación con el Q3 2024. Los ingresos totales del año 2024 alcanzaron $130.1 millones, en comparación con $77.4 millones en 2023.

Los desarrollos clave incluyen la aprobación de la FDA para la etiqueta ampliada de IMCIVREE para tratar a niños tan jóvenes como de 2 años, y la finalización de la inscripción en el ensayo de Fase 2 del agonista oral MC4R bivamelagon. La compañía recaudó $75 millones a través de una oferta de acciones ATM, extendiendo su disponibilidad de efectivo hasta 2027.

Los resultados financieros muestran una pérdida neta en el Q4 2024 de $44.6 millones ($0.72 por acción). Los gastos de I+D aumentaron a $238.0 millones para 2024, mientras que los gastos SG&A alcanzaron $144.3 millones. La posición de efectivo al 31 de diciembre de 2024 era de $320.6 millones.

리듬 제약 (RYTM)은 IMCIVREE에 대한 2024년 4분기 글로벌 매출이 $41.8 백만에 달하며, 이는 2024년 3분기 대비 26% 증가한 수치라고 보고했습니다. 2024년 전체 수익은 $130.1 백만에 이르며, 이는 2023년의 $77.4 백만과 비교됩니다.

주요 개발 사항으로는 2세 어린이까지 치료할 수 있도록 IMCIVREE의 확장된 라벨에 대한 FDA 승인이 있으며, 구강 MC4R 작용제인 비바멜라곤의 2상 시험 등록 완료가 포함됩니다. 회사는 ATM 주식 공모를 통해 $75 백만을 모금하여 2027년까지 현금 운영을 연장했습니다.

재무 결과는 2024년 4분기 순손실이 $44.6 백만 ($0.72 주당)이라고 보여줍니다. R&D 비용은 2024년 $238.0 백만으로 증가했으며, SG&A 비용은 $144.3 백만에 도달했습니다. 2024년 12월 31일 기준 현금 보유액은 $320.6 백만이었습니다.

Rhythm Pharmaceuticals (RYTM) a annoncé des ventes mondiales au T4 2024 de $41.8 millions pour IMCIVREE, en hausse de 26 % par rapport au T3 2024. Le chiffre d'affaires total pour l'année 2024 a atteint $130.1 millions, contre $77.4 millions en 2023.

Les développements clés incluent l'approbation de la FDA pour l'étiquetage élargi d'IMCIVREE permettant de traiter des enfants dès l'âge de 2 ans, ainsi que l'achèvement de l'inscription dans l'essai de phase 2 de l'agoniste oral MC4R bivamelagon. L'entreprise a levé $75 millions grâce à une offre d'actions ATM, prolongeant ainsi sa trésorerie jusqu'en 2027.

Les résultats financiers montrent une perte nette au T4 2024 de $44.6 millions ($0.72 par action). Les dépenses de R&D ont augmenté à $238.0 millions pour 2024, tandis que les dépenses SG&A ont atteint $144.3 millions. La position de trésorerie au 31 décembre 2024 était de $320.6 millions.

Rhythm Pharmaceuticals (RYTM) berichtete von globalen Verkäufen im Q4 2024 in Höhe von $41.8 Millionen für IMCIVREE, was einem Anstieg von 26 % im Vergleich zum Q3 2024 entspricht. Der Gesamtumsatz für das Jahr 2024 erreichte $130.1 Millionen, verglichen mit $77.4 Millionen im Jahr 2023.

Wichtige Entwicklungen umfassen die FDA-Zulassung für das erweiterte Label von IMCIVREE zur Behandlung von Kindern ab 2 Jahren sowie den Abschluss der Rekrutierung in der Phase-2-Studie des oralen MC4R-Agonisten Bivamelagon. Das Unternehmen hat $75 Millionen durch ein ATM-Aktienangebot gesammelt, wodurch die Liquiditätsreserve bis 2027 verlängert wurde.

Die finanziellen Ergebnisse zeigen einen Nettoverlust im Q4 2024 von $44.6 Millionen ($0.72 pro Aktie). Die F&E-Ausgaben stiegen auf $238.0 Millionen für 2024, während die SG&A-Ausgaben $144.3 Millionen erreichten. Die Liquiditätsposition zum 31. Dezember 2024 betrug $320.6 Millionen.

Positive
  • Q4 revenue up 26% QoQ to $41.8M
  • Full year revenue grew 68% YoY to $130.1M
  • $75M raised through ATM offering
  • Cash runway extended into 2027
  • FDA approval for expanded label to include children aged 2+
Negative
  • Net loss increased to $264.6M in 2024 vs $184.7M in 2023
  • R&D expenses jumped 76% to $238.0M
  • SG&A expenses increased 23% to $144.3M

Insights

Rhythm Pharmaceuticals delivered robust Q4 2024 revenue growth with IMCIVREE sales reaching $41.8 million, representing a 26% sequential increase and bringing full-year 2024 revenue to $130.1 million – a 68% year-over-year increase. This acceleration suggests strong market adoption for IMCIVREE in Bardet-Biedl syndrome, with the U.S. market accounting for 76% of revenue but international sales representing a significant growth opportunity.

The FDA's approval to expand IMCIVREE's label to children as young as 2 years old is strategically important, potentially increasing the addressable patient population by 15-20% based on age demographics in rare genetic obesity conditions. This regulatory win, coupled with similar approval in the UK, strengthens Rhythm's competitive position in the rare obesity space where few effective treatments exist.

The company's pipeline momentum is accelerating with completed enrollment across multiple late-stage trials. The upcoming Q2 2025 readout for setmelanotide in acquired hypothalamic obesity represents a potential inflection point, as this indication has a substantially larger patient population than the company's current approved indications. The Phase 2 trial completion for oral MC4R agonist bivamelagon further diversifies their approach to treating obesity-related conditions.

While operating losses increased to $264.6 million for 2024, this reflects strategic R&D investments including the $92.4 million bivamelagon acquisition from LG Chem – a differentiated oral therapy that could expand treatment options beyond injectable setmelanotide. Excluding this one-time acquisition cost, the underlying operational burn rate appears more sustainable.

Rhythm's financial position is solid with $320.6 million in cash and investments as of December 31, 2024, plus an additional $34.7 million raised in January 2025. This extended cash runway into 2027 provides substantial operational flexibility through multiple clinical readouts that could drive valuation inflection points.

Rhythm's clinical momentum in rare obesity disorders is accelerating, with the company strategically expanding both breadth of indications and treatment modalities. The expanded FDA approval for IMCIVREE in children as young as 2 years old represents more than just incremental patient population growth – it establishes Rhythm's first-mover advantage in pediatric genetic obesity treatment during a critical developmental window when intervention may yield enhanced long-term metabolic benefits.

The company's multi-pronged approach to MC4R pathway modulation deserves attention. While injectable setmelanotide has proven effective, the advancement of oral bivamelagon could dramatically expand patient acceptance and compliance. The completion of the Phase 2 trial enrollment for this oral candidate in acquired hypothalamic obesity is particularly significant as this represents a substantially larger addressable market than their current rare genetic indications – potentially 10-20 times larger based on prevalence estimates.

The Phase 3 EMANATE trial's innovative four-substudy design (SH2B1, POMC/PCSK1, SRC1, and LEPR) creates multiple independent opportunities for label expansion while efficiently utilizing clinical resources. This approach allows for sequential data readouts and potential approvals, creating a steady stream of catalysts through 2026 while mitigating the risk associated with any single genetic subset.

Real-world data showing >5% weight reduction in pediatric hypothalamic obesity patients provides important validation beyond controlled clinical settings. This evidence supports setmelanotide's effectiveness in the complex real-world setting where treatment options for these patients remain severely

The expansion into Prader-Willi syndrome (PWS) represents a strategic move into an indication with established diagnostic pathways and higher awareness among clinicians. While challenging due to the complex nature of PWS, success here would significantly expand Rhythm's addressable market.

The Japanese cohort completion highlights Rhythm's global regulatory strategy, potentially opening access to the world's third-largest pharmaceutical market where obesity treatments face different regulatory and cultural considerations than Western markets.

-- Fourth quarter 2024 net revenue from global sales of IMCIVREE® (setmelanotide) of $41.8 million --

-- On track to report topline data from global Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity in the second quarter of 2025 --

 -- Completed enrollment in the Phase 2 trial of oral MC4R agonist bivamelagon in acquired hypothalamic obesity --

-- FDA approved expanded label for IMCIVREE to include children as young as 2 years old --

-- Raised approximately $75 million in gross proceeds under ATM equity offering program; Cash runway extended into 2027 --

-- Management to host conference call today at 8:00 a.m. ET --

BOSTON, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global 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 fourth quarter and full year ended December 31, 2024.

“Rhythm delivered solid IMCIVREE global sales growth in the fourth quarter and is poised to drive continued growth in 2025,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “Our Phase 3 trial in acquired hypothalamic obesity (HO) remains on track as we expect to disclose topline data in the second quarter of 2025. We are well capitalized as we strengthened our balance sheet with approximately $75 million in gross proceeds raised under our ATM program, which extends our cash runway into 2027, enabling us to execute on multiple clinical milestones expected in the year ahead.”

Fourth Quarter and Recent Business Highlights

  • Revenue from global sales of IMCIVREE was $41.8 million for the fourth quarter of 2024, an increase of 26% percent on a sequential basis from the third quarter of 2024, primarily driven by sales of IMCIVREE for the treatment of Bardet-Biedl syndrome (BBS). In the fourth quarter of 2024, revenue of $31.7 million, or 76% of product revenue, was generated in the United States, an increase of 36.2% on a sequential basis; revenue of $10.1 million, or 24% of product revenue, was generated outside the United States;
  • Today, the Company announced that it raised approximately $75 million in gross proceeds from the sale of approximately 1.3 million shares of common stock at a weighted average price of $56.30 under its “at the market” equity offering program (the “ATM Program”) during the fourth quarter of 2024 and in January 2025;
  • Today, Rhythm announced that it completed enrollment in the Phase 2 trial evaluating oral MC4R agonist bivamelagon (LB54640) in acquired hypothalamic obesity;
  • Today, Rhythm announced a strategic partnership agreement with Trispera Pharma Solutions in Turkey;
  • On January 10, 2025, Rhythm announced that it:
    • Completed enrollment in its supplemental, 12-patient Japanese cohort of the global Phase 3 trial evaluating setmelanotide in acquired HO. Data from this supplemental cohort will serve as the basis for a regulatory submission in Japan;
    • Completed enrollment in the Phase 3 EMANATE trial of setmelanotide, which is comprised of four substudies: SH2B1 (n=121); POMC and/or PCSK1 (n=79); SRC1 (n=73); and LEPR (n=23). The four-substudy design of this trial allows for independent data readouts and potential registration for each genetic cohort;
  • On December 20, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for IMCIVREE to include children as young as 2 years old with syndromic or monogenic obesity due to BBS or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency;
  • On December 3, 2024, Rhythm announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE to include the treatment of obesity and control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adult and pediatric patients as young as 2 years old and older; and
  • During the annual meeting of the European Society for Paediatric Endocrinology in November 2024, Rhythm presented new, real-world data that showed four pediatric patients, two with acquired HO and two with congenital HO, achieved >5% weight reduction at three months on setmelanotide. The Company announced plans for a new, 34-week substudy in the ongoing setmelanotide Phase 3 trial in 39 patients with congenital HO aged 4 years and older.

Anticipated Upcoming Milestones

Rhythm expects to achieve the following near-term milestones:

  • Begin enrolling the first patients with congenital HO in a 34-week substudy of setmelanotide being conducted under the protocol for its global Phase 3 trial in the first quarter of 2025;
  • Begin enrolling the first patients with Prader-Willi syndrome (PWS) in a 26-week, open-label Phase 2 trial evaluating setmelanotide in the first quarter of 2025;
  • Begin enrolling patients with acquired HO in Part C of the Phase 1 trial evaluating the weekly, MC4R agonist RM-718 in the first quarter of 2025;
  • Announce top-line data in the Phase 3 trial evaluating setmelanotide in acquired HO in the second quarter of 2025;
  • Announce topline data from the Phase 2 trial of bivamelagon in acquired HO in the second half of 2025; and
  • Announce top-line data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first half of 2026.

Fourth Quarter and Full Year 2024 Financial Results:

Cash Position: As of December 31, 2024, cash, cash equivalents and short-term investments were approximately $320.6 million, as compared to $275.8 million as of December 31, 2023. The December 31, 2024 cash balance does not include gross proceeds of approximately $34.7 million from the sale of stock under the Company’s ATM program executed during January 2025.

Revenue: Net product revenues relating to global sales of IMCIVREE were $41.8 million for the fourth quarter of 2024 and $130.1 million for the full year of 2024, as compared to $24.2 million for the fourth quarter of 2023 and $77.4 million for the full year of 2023.

R&D Expenses: R&D expenses were $41.2 million in the fourth quarter of 2024 and $238.0 million for the full year of 2024, as compared to $29.9 million in the fourth quarter of 2023 and $135.0 million for the full year of 2023. The year-over-year increase was primarily due to increased costs associated with the acquisition of bivamelagon from LG Chem and its development with certain additional product manufacturing activity, ongoing clinical trials and increased headcount. This increase was partially offset by decreased costs in other trials.

SG&A Expenses: SG&A expenses were $38.1 million for the fourth quarter of 2024 and $144.3 million for the full year of 2024, as compared to $32.4 million for the fourth quarter of 2023 and $117.5 million for the full year of 2023. The year-over-year increase was primarily due to increased headcount, marketing and promotions costs and expenses for professional services and partially offset by inventory-related costs that were capitalized as labor and overhead.

Other income (expense), net: Other income (expense), net was ($2.1) million for the fourth quarter of 2024 and $5.2 million for the full year of 2024.

Net Loss: Net loss attributable to common stockholders was ($44.6) million for the fourth quarter of 2024 and ($264.6) million for the full year of 2024, or a net loss per basic and diluted share of ($0.72) and ($4.34), respectively, as compared to a net loss attributable to common stockholders of ($41.6) million for the fourth quarter of 2023 and ($184.7) million for the full year of 2023, or a net loss per basic and diluted share of ($0.70) and ($3.20), respectively.

Financial Guidance: For the year ended December 31, 2024, the Company had GAAP total operating expenses of $382.3 million, inclusive of $92.4 million associated with the acquisition of the rights to bivamelagon from LG Chem. The Company today reported non-GAAP Operating Expenses for the year ended December 31, 2024 of $250.2 million, which is derived from GAAP total operating expenses of $382.3 million less $39.7 million in stock-based compensation and $92.4 million associated with the acquisition of the rights to bivamelagon from LG Chem.

For the year ending December 31, 2025, Rhythm anticipates approximately $285 million to $315 million in Non-GAAP Operating Expenses. Non-GAAP Operating Expenses are derived from:

  • 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.

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 existing cash, cash equivalents and short-term investments as of December 31, 2024, and including proceeds from the sale of stock through its ATM program during January 2025, will be sufficient to fund its operating expenses and capital expenditure requirements into 2027.

Conference Call Information
Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET today to review its fourth quarter and full year 2024 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 U.S. Food and Drug Administration (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 LB54640 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 ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

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 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; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product candidates; the estimated market size and addressable population for our drug products; the announcement of data from our clinical trials, including 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, and the Phase 2 trial evaluating the oral MC4R agonist bivamelagon in acquired hypothalamic obesity; Part C of the Phase 1 trial evaluating RM-718; the open-label Phase 2 trial evaluating setmelanotide in patients with Prader-Willi syndrome; the ongoing enrollment in our clinical trials; existing or future collaboration agreements; 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; and 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”, “aim” 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 ability to achieve necessary regulatory approvals, risks associated with data analysis and reporting, failure to identify and develop additional product candidates, 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, the impact of competition, risks relating to product liability lawsuits, inability to maintain collaborations, or the failure of these collaborations, our reliance on third parties, risks relating to intellectual property, our ability to hire and retain necessary personnel, general economic conditions, risks related to internal control over financial reporting, and the other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 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:
Sheryl Seapy
Real Chemistry
(949) 903-4750
sseapy@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 December 31, Year Ended December 31,
 
 2024
 2023
 2024
 2023
 
evenues:                
Product revenue, net$41,830  $24,234  $130,126  $77,428  
Total revenues 41,830   24,234   130,126   77,428  
Costs and expenses:                
Cost of sales 3,787   3,233   13,368   9,302  
Research and development 41,168   29,892   237,957   134,951  
Selling, general, and administrative 38,130   32,374   144,304   117,532  
Total costs and expenses 83,085   65,499   395,629   261,785  
Loss from operations (41,255)  (41,265)  (265,503)  (184,357) 
Other income (expense):                
Other income (expense), net (195)  39   2,239   190  
Gain on settlement of forward contract       8,900     
Interest expense (5,447)  (4,018)  (20,603)  (13,892) 
Interest income 3,514   3,819   14,711   13,945  
Total other income (expense), net (2,128)  (160)  5,247   243  
Loss before income taxes (43,383)  (41,425)  (260,256)  (184,114) 
Provision for income taxes (89)  196   346   564  
Net loss$(43,294) $(41,621) $(260,602) $(184,678) 
Accrued dividends on convertible preferred stock (1,340)     (3,970)    
Net loss attributable to common stockholders$(44,634) $(41,621) $(264,572) $(184,678) 
Net loss per share attributable to common stockholders, basic and diluted$(0.72) $(0.70) $(4.34) $(3.20) 
                 
Weighted-average common shares outstanding, basic and diluted 61,596,442   59,211,199   60,995,204   57,673,128  
                 
Other comprehensive loss:                
Net loss attributable to common stockholders$(44,634) $(41,621) $(264,572) $(184,678) 
Foreign currency translation adjustment 977   76   2   (140) 
Unrealized (loss) gain, net on marketable securities, net of tax (412)  (175)  (175)  366  
Comprehensive loss$(44,069) $(41,720) $(264,745) $(184,452) 
 


Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
 
 December 31,
2024
 December 31,
2023

 
Assets        
Current assets:        
Cash and cash equivalents$89,137  $60,081  
Short-term investments 231,428   215,765  
Accounts receivable, net 18,512   14,867  
Inventory 18,741   8,624  
Prepaid expenses and other current assets 16,382   8,931  
Total current assets 374,200   308,268  
Property and equipment, net 632   1,341  
Right-of-use asset 3,477   781  
Intangible assets, net 6,174   7,028  
Restricted cash 464   328  
Other long-term assets 7,326   14,999  
Total assets$392,273  $332,745  
Liabilities, Convertible Preferred Stock and Stockholders’ Equity        
Current liabilities:        
Accounts payable$12,328  $4,885  
Accrued expenses and other current liabilities 62,658   48,262  
Other current liability - LG Chem 37,704     
Deferred revenue 1,286   1,286  
Deferred royalty obligation, current 1,541     
Lease liability    770  
Total current liabilities 115,517   55,203  
Long-term liabilities:       
Deferred royalty obligation 108,269   106,143  
Lease liability, non-current 3,938   490  
Derivative liability    1,150  
Total liabilities 227,724   162,986  
Commitments and contingencies        
Series A convertible preferred stock, $0.001 par value: 150,000 shares
authorized; 150,000 and 0 shares issued and outstanding at December 31, 2024
and December 31, 2023, respectively. Liquidation preference of $150,000 as of
December 31, 2024.
 142,820     
Stockholders’ equity:        
Common stock, $0.001 par value: 120,000,000 shares authorized; 62,390,654
and 59,426,559 shares issued and outstanding at December 31, 2024 and
December 31, 2023, respectively
 61   59  
Additional paid-in capital 1,177,045   1,064,302  
Accumulated other comprehensive (loss) income (39)  134  
Accumulated deficit (1,155,338)  (894,736) 
Total stockholders’ equity 21,729   169,759  
Total liabilities, convertible preferred stock and stockholders’ equity$392,273  $332,745  

FAQ

What was Rhythm Pharmaceuticals (RYTM) Q4 2024 revenue from IMCIVREE sales?

RYTM reported Q4 2024 global IMCIVREE sales of $41.8 million, with $31.7 million from US sales and $10.1 million from international markets.

When will RYTM report topline data for setmelanotide in hypothalamic obesity?

Rhythm expects to announce topline data from the Phase 3 trial of setmelanotide in acquired hypothalamic obesity in Q2 2025.

How much cash does RYTM have and how long will it last?

RYTM had $320.6M in cash as of Dec 31, 2024, plus $34.7M raised in January 2025, extending runway into 2027.

What is RYTM's expected non-GAAP operating expenses for 2025?

Rhythm anticipates non-GAAP operating expenses of $285-315 million for 2025.

What was the net loss for RYTM in full year 2024?

RYTM reported a net loss of $264.6 million ($4.34 per share) for full year 2024.

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3.31B
55.10M
0.53%
115.09%
8.87%
Biotechnology
Pharmaceutical Preparations
Link
United States
BOSTON