Corcept Therapeutics Announces Fourth Quarter and Full-Year 2024 Audited Financial Results and Provides Corporate Update
Corcept Therapeutics (NASDAQ: CORT) reported strong financial results for Q4 and full-year 2024. The company achieved revenue of $675.0 million in 2024, marking a 40% increase from 2023, with Q4 revenue at $181.9 million. Net income reached $141.2 million for 2024, up 33% year-over-year.
The company's cash position strengthened to $603.2 million as of December 31, 2024. Corcept provided 2025 revenue guidance of $900-950 million. Key developments include the submission of a New Drug Application (NDA) for relacorilant in hypercortisolism treatment, positive results from the GRACE and GRADIENT trials, and promising outcomes from the CATALYST study showing that 23.8% of patients with difficult-to-control type 2 diabetes have hypercortisolism.
Corcept Therapeutics (NASDAQ: CORT) ha riportato risultati finanziari solidi per il quarto trimestre e per l'intero anno 2024. L'azienda ha registrato entrate di 675,0 milioni di dollari nel 2024, segnando un aumento del 40% rispetto al 2023, con entrate nel quarto trimestre pari a 181,9 milioni di dollari. L'utile netto ha raggiunto i 141,2 milioni di dollari per il 2024, in aumento del 33% rispetto all'anno precedente.
La posizione di cassa dell'azienda si è rafforzata a 603,2 milioni di dollari al 31 dicembre 2024. Corcept ha fornito una previsione di entrate per il 2025 di 900-950 milioni di dollari. Sviluppi chiave includono la presentazione di una Nuova Domanda di Farmaco (NDA) per il relacorilant nel trattamento dell'ipercortisolismo, risultati positivi dagli studi GRACE e GRADIENT, e risultati promettenti dallo studio CATALYST che mostrano che il 23,8% dei pazienti con diabete di tipo 2 difficile da controllare ha ipercortisolismo.
Corcept Therapeutics (NASDAQ: CORT) reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024. La compañía logró ingresos de 675,0 millones de dólares en 2024, marcando un aumento del 40% en comparación con 2023, con ingresos del cuarto trimestre de 181,9 millones de dólares. La utilidad neta alcanzó los 141,2 millones de dólares para 2024, un aumento del 33% interanual.
La posición de efectivo de la compañía se fortaleció a 603,2 millones de dólares al 31 de diciembre de 2024. Corcept proporcionó una guía de ingresos para 2025 de 900-950 millones de dólares. Los desarrollos clave incluyen la presentación de una Nueva Solicitud de Medicamento (NDA) para relacorilant en el tratamiento del hipercortisolismo, resultados positivos de los ensayos GRACE y GRADIENT, y resultados prometedores del estudio CATALYST que muestran que el 23,8% de los pacientes con diabetes tipo 2 difícil de controlar tienen hipercortisolismo.
Corcept Therapeutics (NASDAQ: CORT)는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했습니다. 이 회사는 2024년에 6억 7천5백만 달러의 수익을 달성하여 2023년 대비 40% 증가했으며, 4분기 수익은 1억 8천1백90만 달러였습니다. 순이익은 2024년 동안 1억 4천1백20만 달러에 도달하여 전년 대비 33% 증가했습니다.
회사의 현금 보유액은 2024년 12월 31일 기준으로 6억 3백20만 달러로 강화되었습니다. Corcept는 2025년 수익 가이던스를 9억-9억 5천만 달러로 제공했습니다. 주요 개발 사항으로는 고코르티솔증 치료를 위한 relacorilant의 신규 의약품 신청(NDA) 제출, GRACE 및 GRADIENT 시험의 긍정적인 결과, 그리고 제어하기 어려운 제2형 당뇨병 환자의 23.8%가 고코르티솔증을 앓고 있다는 CATALYST 연구의 유망한 결과가 포함됩니다.
Corcept Therapeutics (NASDAQ: CORT) a annoncé de solides résultats financiers pour le quatrième trimestre et l'année complète 2024. L'entreprise a réalisé des revenus de 675,0 millions de dollars en 2024, marquant une augmentation de 40 % par rapport à 2023, avec des revenus au quatrième trimestre de 181,9 millions de dollars. Le bénéfice net a atteint 141,2 millions de dollars pour 2024, en hausse de 33 % par rapport à l'année précédente.
La position de trésorerie de l'entreprise s'est renforcée à 603,2 millions de dollars au 31 décembre 2024. Corcept a fourni des prévisions de revenus pour 2025 de 900 à 950 millions de dollars. Les développements clés incluent la soumission d'une Nouvelle Demande de Médicament (NDA) pour le relacorilant dans le traitement de l'hypercortisolisme, des résultats positifs des essais GRACE et GRADIENT, et des résultats prometteurs de l'étude CATALYST montrant que 23,8 % des patients atteints de diabète de type 2 difficile à contrôler souffrent d'hypercortisolisme.
Corcept Therapeutics (NASDAQ: CORT) hat starke finanzielle Ergebnisse für das vierte Quartal und das Gesamtjahr 2024 berichtet. Das Unternehmen erzielte Einnahmen von 675,0 Millionen Dollar im Jahr 2024, was einem Anstieg von 40% im Vergleich zu 2023 entspricht, wobei die Einnahmen im vierten Quartal 181,9 Millionen Dollar betrugen. Der Nettogewinn erreichte 141,2 Millionen Dollar für 2024, was einem Anstieg von 33% im Jahresvergleich entspricht.
Die Liquiditätsposition des Unternehmens stärkte sich zum 31. Dezember 2024 auf 603,2 Millionen Dollar. Corcept gab eine Umsatzprognose für 2025 von 900-950 Millionen Dollar bekannt. Zu den wichtigsten Entwicklungen gehören die Einreichung eines Neuen Arzneimittelantrags (NDA) für Relacorilant zur Behandlung von Hyperkortisolismus, positive Ergebnisse aus den Studien GRACE und GRADIENT sowie vielversprechende Ergebnisse aus der CATALYST-Studie, die zeigen, dass 23,8% der Patienten mit schwer zu kontrollierendem Typ-2-Diabetes Hyperkortisolismus haben.
- Revenue grew 40% to $675.0M in 2024
- Net income increased 33% to $141.2M
- Strong cash position of $603.2M
- Positive 2025 revenue guidance of $900-950M
- Successful NDA submission for relacorilant
- Record number of new Korlym prescribers and patients
- Q4 net income declined to $30.7M from $31.4M YoY
- DAZALS study missed primary endpoint in ALS treatment
-
2024 revenue of
$675.0 million -
2025 revenue guidance of
$900 $950 million -
2024 net income of
$141.2 million -
Cash and investments of
$603.2 million
Financial Results
“Once again, we had a record number of new Korlym® prescribers and a record number of patients receiving Korlym in the quarter. Physicians are increasingly aware of hypercortisolism’s true prevalence and the poor health outcomes for patients who go untreated. Screening is becoming more common and the number of patients receiving appropriate care continues to increase. We are confident that our Cushing’s syndrome business will grow for many years,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.
Corcept’s fourth quarter 2024 revenue was
Net income was
Cash and investments were
Clinical Development
“We made substantial progress in all of our clinical development programs in 2024,” added Dr. Belanoff. “We submitted a New Drug Application (NDA) for our proprietary, selective cortisol modulator, relacorilant, as a treatment for hypercortisolism, based on compelling results from our GRACE, GRADIENT, long-term extension and Phase 2 studies. Our CATALYST study demonstrated that hypercortisolism is much more common than previously assumed in patients with difficult-to-control diabetes and that treatment with a cortisol modulator can significantly improve their glucose control. We expect data from ROSELLA, our pivotal study in women with platinum-resistant ovarian cancer, this quarter.”
Hypercortisolism (Cushing’s Syndrome)
- Relacorilant for patients with hypercortisolism – NDA submitted in December 2024
- GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism – primary endpoint achieved in randomized withdrawal phase; open-label phase demonstrated clinically meaningful improvements in a broad range of hypercortisolism signs and symptoms; relacorilant was well-tolerated, consistent with its known safety profile, with no cases of endometrial hypertrophy or drug-induced vaginal bleeding, relacorilant-induced hypokalemia, adrenal insufficiency or QT prolongation
- GRADIENT – Supportive data for NDA – Patients treated with relacorilant exhibited clinically meaningful improvements in a broad range of hypercortisolism signs and symptoms in randomized, double-blind, placebo-controlled, Phase 3 trial in 137 patients with hypercortisolism caused by adrenal gland pathology; relacorilant was well-tolerated, consistent with its known safety profile, including no cases of endometrial hypertrophy or drug-induced vaginal bleeding, relacorilant-induced hypokalemia, adrenal insufficiency or QT prolongation
- Phase 3 long-term extension study – Supportive data for NDA – clinically meaningful and durable cardiometabolic improvements exhibited in 116 patients who completed the GRACE, GRADIENT or Phase 2 relacorilant studies, with no new or notable safety signals observed; treatment duration of up to six years
- CATALYST Part 1 – Of 1,057 patients with difficult-to-control type 2 diabetes, 23.8 percent were found to have hypercortisolism
- CATALYST Part 2 – Primary endpoint met in randomized, double-blind, placebo-controlled study of 136 patients identified with hypercortisolism in CATALYST Part 1; patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c, with a decrease from baseline of 1.47 percent compared to a decrease of 0.15 percent in patients who received placebo (p-value: < 0.0001); safety profile of Korlym in this study was consistent with the medication’s label; no new adverse events were observed
- MOMENTUM – 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension to begin this quarter
“The positive results from our pivotal GRACE study, and confirmatory evidence from our GRADIENT, long-term extension and Phase 2 studies, provide powerful support for relacorilant’s NDA in hypercortisolism. Patients in these studies experienced clinically significant improvements in a wide array of hypercortisolism’s signs and symptoms, without the off-target effects and toxicities that accompany currently available treatments. Relacorilant’s strong efficacy and safety profile positions it to become the new standard of care for patients with hypercortisolism,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
“CATALYST is a landmark study that will change the way physicians treat some of their sickest patients. Its findings are striking: One-in-four patients whose type 2 diabetes resists treatment with the best available medications have hypercortisolism and hyperglycemia in these patients responds powerfully to treatment with a cortisol modulator,” added Dr. Guyer. “We plan to build on these findings. Our MOMENTUM study will establish the prevalence of hypercortisolism in patients with resistant hypertension.”
Oncology
- ROSELLA – Results expected this quarter from pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer
-
Early-stage prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer, conducted in collaboration with the University of
Chicago
“If ROSELLA replicates the positive results of our large, controlled, Phase 2 study, it will constitute a major medical advance and serve as the basis for relacorilant’s next NDA. We expect progression-free survival results this quarter,” said Dr. Guyer. “Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer.”
Amyotrophic Lateral Sclerosis (ALS)
- DAZALS – In a randomized, double-blind, placebo-controlled Phase 2 study in 249 patients with ALS, dazucorilant did not meet its primary endpoint of improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R); a statistically significant improvement in overall survival at week 24 was observed; an open-label, long-term extension study is ongoing and one-year overall survival results are expected in the second quarter
“ALS is a devastating disease, with few good treatment options. In DAZALS, patients who received dazucorilant did not show improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R), which was the study’s primary endpoint. An improvement in overall survival was observed at week 24 of the study – no deaths (0 of 83 patients) were observed in the 300 mg dazucorilant arm, compared to 5 deaths (5 of 82 patients) in the placebo group (p-value: 0.02). The open-label, long-term extension study is ongoing and we expect one-year overall survival results in the second quarter,” said Dr. Guyer.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- MONARCH – Enrollment continues in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 120 patients with biopsy-confirmed MASH and in 75 patients with presumed MASH
“In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures and was well-tolerated. We look forward to building on these promising results in our MONARCH study,” said Dr. Guyer.
Conference Call
We will hold a conference call on February 26, 2025, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym, the first medication approved by the
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website.
In this press release, forward-looking statements include those concerning: trends in medical practice, including trends regarding the identification and treatment of patients with hypercortisolism; our 2025 revenue guidance and factors that may affect our revenue and continued revenue growth, such as increased uptake or price reductions in competing medications, including generic versions of Korlym, and the performance of our third-party pharmacy and other vendors; relacorilant as a treatment for patients with hypercortisolism and solid tumors, dazucorilant as a treatment for patients with ALS, miricorilant as a treatment for patients with MASH; the timing and outcome of relacorilant’s NDA in hypercortisolism; the timing and outcome of our CATALYST, MOMENTUM, ROSELLA, DAZALS and MONARCH trials and their impact on patient care and Corcept’s commercial prospects; and the accrual and attributes of our clinical data. We disclaim any intention or duty to update forward-looking statements made in this press release.
CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) |
|||||
|
December 31, 2024 |
|
December 31, 2023(1) |
||
|
(Unaudited) |
|
|
||
Assets |
|
|
|
||
Cash and investments |
$ |
603,165 |
|
$ |
425,397 |
Trade receivables, net of allowances |
|
53,976 |
|
|
41,123 |
Insurance recovery receivable related to Melucci litigation |
|
— |
|
|
14,000 |
Inventory |
|
15,995 |
|
|
15,974 |
Operating lease right-of-use asset |
|
5,324 |
|
|
120 |
Deferred tax assets, net |
|
130,914 |
|
|
90,605 |
Other assets |
|
31,179 |
|
|
34,298 |
Total assets |
$ |
840,553 |
|
$ |
621,517 |
Liabilities and Stockholders’ Equity |
|
|
|
||
Accounts payable |
$ |
15,376 |
|
$ |
17,396 |
Accrued settlement related to Melucci litigation |
|
— |
|
|
14,000 |
Operating lease liabilities |
|
6,936 |
|
|
151 |
Other liabilities |
|
138,652 |
|
|
83,265 |
Stockholders’ equity |
|
679,589 |
|
|
506,705 |
Total liabilities and stockholders’ equity |
$ |
840,553 |
|
$ |
621,517 |
|
|
|
|
||
(1) Derived from audited financial statements at that date |
|||||
CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (In thousands, except per share data) |
|||||||||||||||
|
Three Months Ended |
|
Year Ended |
||||||||||||
|
December 31, |
|
December 31, |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenues |
|
|
|
|
|
|
|
||||||||
Product revenue, net |
$ |
181,890 |
|
|
$ |
135,405 |
|
|
$ |
675,040 |
|
|
$ |
482,375 |
|
|
|
|
|
|
|
|
|
||||||||
Operating expenses |
|
|
|
|
|
|
|
||||||||
Cost of sales |
|
2,956 |
|
|
|
1,876 |
|
|
|
10,882 |
|
|
|
6,481 |
|
Research and development |
|
70,300 |
|
|
|
54,707 |
|
|
|
246,887 |
|
|
|
184,353 |
|
Selling, general and administrative |
|
83,372 |
|
|
|
47,152 |
|
|
|
280,320 |
|
|
|
184,259 |
|
Total operating expenses |
|
156,628 |
|
|
|
103,735 |
|
|
|
538,089 |
|
|
|
375,093 |
|
Income from operations |
|
25,262 |
|
|
|
31,670 |
|
|
|
136,951 |
|
|
|
107,282 |
|
Interest and other income |
|
6,698 |
|
|
|
5,139 |
|
|
|
24,542 |
|
|
|
17,275 |
|
Income before income taxes |
|
31,960 |
|
|
|
36,809 |
|
|
|
161,493 |
|
|
|
124,557 |
|
Income tax expense |
|
(1,214 |
) |
|
|
(5,454 |
) |
|
|
(20,284 |
) |
|
|
(18,417 |
) |
Net income |
$ |
30,746 |
|
|
$ |
31,355 |
|
|
$ |
141,209 |
|
|
$ |
106,140 |
|
|
|
|
|
|
|
|
|
||||||||
Net income attributable to common stockholders |
$ |
30,395 |
|
|
$ |
31,138 |
|
|
$ |
139,733 |
|
|
$ |
105,496 |
|
|
|
|
|
|
|
|
|
||||||||
Basic net income per common share |
$ |
0.29 |
|
|
$ |
0.30 |
|
|
$ |
1.35 |
|
|
$ |
1.02 |
|
|
|
|
|
|
|
|
|
||||||||
Diluted net income per common share |
$ |
0.26 |
|
|
$ |
0.28 |
|
|
$ |
1.23 |
|
|
$ |
0.94 |
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares outstanding used in computing net income per common share |
|
|
|
|
|
|
|
||||||||
Basic |
|
103,643 |
|
|
|
102,455 |
|
|
|
103,232 |
|
|
|
103,560 |
|
Diluted |
|
118,459 |
|
|
|
110,886 |
|
|
|
113,480 |
|
|
|
111,742 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20250226825813/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
Source: Corcept Therapeutics
FAQ
What were Corcept Therapeutics (CORT) key financial metrics for 2024?
What is CORT's revenue guidance for 2025?
What were the main findings of CORT's CATALYST study in 2024?
What major regulatory submission did CORT complete in 2024?
When will CORT release results from the ROSELLA ovarian cancer trial?
