Corcept Therapeutics Announces Third Quarter Financial Results, Positive Results From Phase 3 GRADIENT Trial in Patients With Cushing’s Syndrome and Provides Corporate Update
Corcept Therapeutics (NASDAQ: CORT) reported strong Q3 2024 financial results with revenue of $182.5 million, up 48% year-over-year. Net income reached $47.2 million with EPS of $0.41. The company increased its 2024 revenue guidance to $675-700 million and reported cash and investments of $547.6 million.
The company announced positive results from its Phase 3 GRADIENT trial in Cushing's syndrome patients, supporting findings from the pivotal GRACE study. Patients treated with relacorilant showed meaningful improvements in various symptoms. Corcept plans to submit a new drug application (NDA) for relacorilant this quarter.
Corcept Therapeutics (NASDAQ: CORT) ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con un fatturato di 182,5 milioni di dollari, in aumento del 48% rispetto all'anno precedente. L'utile netto ha raggiunto i 47,2 milioni di dollari con un utile per azione (EPS) di 0,41 dollari. L'azienda ha aumentato le previsioni di fatturato per il 2024 a 675-700 milioni di dollari e ha riportato disponibilità liquide e investimenti per un totale di 547,6 milioni di dollari.
L'azienda ha annunciato risultati positivi dal suo studio di fase 3 GRADIENT sui pazienti con sindrome di Cushing, a sostegno delle conclusioni dello studio fondamentale GRACE. I pazienti trattati con relacorilant hanno mostrato miglioramenti significativi in vari sintomi. Corcept prevede di presentare una nuova richiesta di approvazione per il farmaco (NDA) per relacorilant entro la fine di questo trimestre.
Corcept Therapeutics (NASDAQ: CORT) reportó resultados financieros sólidos para el tercer trimestre de 2024, con ingresos de 182.5 millones de dólares, lo que representa un aumento del 48% en comparación con el año anterior. La renta neta alcanzó los 47.2 millones de dólares con una utilidad por acción (EPS) de 0.41 dólares. La compañía incrementó su guía de ingresos para 2024 a 675-700 millones de dólares y reportó efectivo e inversiones por un total de 547.6 millones de dólares.
La compañía anunció resultados positivos de su ensayo de fase 3 GRADIENT en pacientes con síndrome de Cushing, respaldando los hallazgos del estudio clave GRACE. Los pacientes tratados con relacorilant mostraron mejoras significativas en varios síntomas. Corcept planea presentar una nueva solicitud de medicamento (NDA) para relacorilant este trimestre.
Corcept Therapeutics (NASDAQ: CORT)는 2024년 3분기 재무 실적을 발표했으며, 수익은 $182.5 백만으로 전년 대비 48% 증가했습니다. 순이익은 4720만 달러에 이르렀고 주당 순이익(EPS)은 0.41달러였습니다. 회사는 2024년 수익 목표를 6억 7500만~7억 달러로 상향 조정했으며, 현금 및 투자 총액은 5억 4760만 달러에 달했습니다.
회사는 쿠싱 증후군 환자를 대상으로 한 3상 GRADIENT 시험에서 긍정적인 결과를 발표했으며, 이는 중요한 GRACE 연구의 결과를 뒷받침합니다. Relacorilant으로 치료받은 환자들은 여러 증상에서 유의미한 개선을 보였습니다. Corcept는 이번 분기에 relacorilant에 대한 새로운 약물 허가 신청(NDA)을 제출할 계획입니다.
Corcept Therapeutics (NASDAQ: CORT) a annoncé de solides résultats financiers pour le troisième trimestre 2024, avec des revenus de 182,5 millions de dollars, en hausse de 48 % par rapport à l'année précédente. Le bénéfice net a atteint 47,2 millions de dollars avec un bénéfice par action (EPS) de 0,41 dollar. L'entreprise a relevé ses prévisions de revenus pour 2024 à 675-700 millions de dollars et a déclaré des liquidités et des investissements de 547,6 millions de dollars.
L'entreprise a annoncé des résultats positifs de son essai de phase 3 GRADIENT chez des patients atteints du syndrome de Cushing, soutenant les résultats de l'étude pionnière GRACE. Les patients traités avec du relacorilant ont montré des améliorations significatives dans divers symptômes. Corcept prévoit de soumettre une nouvelle demande de médicament (NDA) pour le relacorilant ce trimestre.
Corcept Therapeutics (NASDAQ: CORT) hat starke Finanzzahlen für das dritte Quartal 2024 veröffentlicht, mit Einnahmen von 182,5 Millionen US-Dollar, was einem Anstieg von 48% im Vergleich zum Vorjahr entspricht. Der Nettogewinn belief sich auf 47,2 Millionen US-Dollar mit einem Gewinn pro Aktie (EPS) von 0,41 US-Dollar. Das Unternehmen hat seine Umsatzprognose für 2024 auf 675-700 Millionen US-Dollar angehoben und meldete Bargeld und Investitionen in Höhe von 547,6 Millionen US-Dollar.
Das Unternehmen kündigte positive Ergebnisse seiner Phase-3-Studie GRADIENT bei Patienten mit Cushing-Syndrom an, die die Ergebnisse der wegweisenden GRACE-Studie unterstützen. Patienten, die mit Relacorilant behandelt wurden, zeigten signifikante Verbesserungen in verschiedenen Symptomen. Corcept plant, in diesem Quartal einen neuen Zulassungsantrag (NDA) für Relacorilant einzureichen.
- Revenue increased 48% YoY to $182.5 million
- Net income grew to $47.2 million from $31.4 million YoY
- EPS increased to $0.41 from $0.28 YoY
- Raised 2024 revenue guidance to $675-700 million
- Strong cash position of $547.6 million
- Positive Phase 3 GRADIENT trial results supporting NDA submission
- Operating expenses increased 47% to $135.9 million YoY
Insights
The Q3 results showcase exceptional performance with
The imminent NDA submission for relacorilant, positive GRADIENT trial results and upcoming data from multiple late-stage trials (CATALYST, ROSELLA, DAZALS) position CORT for significant near-term catalysts. The diversified pipeline spanning Cushing's syndrome, oncology, ALS and MASH demonstrates strong growth potential beyond the core business.
The GRADIENT trial results strongly validate relacorilant's efficacy profile, showing meaningful improvements in key symptoms without serious adverse effects common to current treatments. Critical improvements were observed in:
- Systolic blood pressure (reduction of 6.6 mm Hg)
- Glucose metabolism (fasting glucose reduction of 22.2 mg/dL)
- Body weight (reduction of 3.9 kg)
The absence of relacorilant-induced hypokalemia, endometrial issues and adrenal insufficiency significantly differentiates it from existing treatments. The comprehensive data package, combining GRACE and GRADIENT results, strengthens the upcoming NDA submission.
-
Revenue of
$182.5 million -
Increase in 2024 revenue guidance to
$675 $700 million $640 $670 million -
Net income per common share of
$0.41 $0.28 -
Cash and investments of
$547.6 million - Results from Phase 3 GRADIENT trial support findings from pivotal Phase 3 GRACE study; new drug application (NDA) of relacorilant to be submitted this quarter
Financial Results
“In the third quarter, we added more Korlym® prescribers and more patients received Korlym treatment than ever before,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “Physicians are increasingly aware of hypercortisolism’s true prevalence and of the poor health outcomes of patients who go untreated. Screening is becoming more common and the number of patients receiving appropriate care continues to increase. For patients and physicians who choose Korlym, our extensive system of support services is critical to optimizing the benefit of our medication.”
Corcept’s third quarter 2024 revenue was
The company increased its 2024 revenue guidance to
Cash and investments were
Clinical Development
“Our clinical development programs have positioned us for a transformative fourth quarter,” added Dr. Belanoff. “We are on track to submit our NDA for relacorilant as a treatment for patients with hypercortisolism (Cushing's syndrome) by year-end. We also expect to release data from (i) the treatment phase of our CATALYST study in patients with Cushing’s syndrome, (ii) ROSELLA, our pivotal study in women with platinum-resistant ovarian cancer, and (iii) DAZALS, our study in patients with amyotrophic lateral sclerosis (ALS) by year-end.”
Cushing’s Syndrome
- Relacorilant for Cushing’s syndrome – NDA submission expected this quarter
- GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with all etiologies of Cushing’s syndrome – 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, with no cases of relacorilant-induced hypokalemia, endometrial hypertrophy or related vaginal bleeding, adrenal insufficiency or QT prolongation
- GRADIENT – Supportive trial 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 Cushing’s syndrome caused by adrenal gland pathology; relacorilant was well-tolerated, with a safety profile consistent with the GRACE study, including no cases of relacorilant-induced hypokalemia, endometrial hypertrophy or related vaginal bleeding, adrenal insufficiency or QT prolongation
- CATALYST – Treatment phase of randomized, double-blind, placebo-controlled study of Korlym in 136 patients with hypercortisolism and difficult-to-control type 2 diabetes; results expected this quarter
“GRADIENT’s positive results in patients with Cushing’s syndrome confirm relacorilant’s promise as a significant medical advancement for the treatment of this deadly disease. As was true in the GRACE study, patients in GRADIENT who received relacorilant experienced clinically meaningful improvements in a broad range of hypercortisolism signs and symptoms, without suffering some of the serious adverse effects that can arise in patients taking currently approved treatments,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “These data will be a powerful addition to relacorilant’s NDA, which we plan to submit by year-end.”
The pivotal Phase 3 GRACE trial is the basis for relacorilant’s NDA in Cushing’s syndrome and met its primary endpoint. Patients in GRACE’s initial, open-label phase exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia and other symptoms experienced by patients with Cushing’s syndrome. In the randomized withdrawal phase, GRACE met its primary endpoint and demonstrated that patients who remained on relacorilant maintained these improvements while those who received placebo saw a significant worsening in their signs and symptoms of hypercortisolism. Consistent with its known safety profile, relacorilant was well-tolerated in both phases of GRACE.
As part of relacorilant’s NDA in Cushing’s syndrome, the 22-week Phase 3 GRADIENT study supports the GRACE trial by providing further evidence of relacorilant’s efficacy and safety profile. Patients treated with relacorilant in the GRADIENT study exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight and body composition compared to baseline, while patients who received placebo did not. The trial’s primary endpoint was the improvement in systolic blood pressure (SBP) compared to placebo with hyperglycemia, weight and body composition as secondary endpoints.
Patients who entered GRADIENT with hypertension and received relacorilant exhibited clinically meaningful and statistically significant improvements in mean SBP at 22 weeks (reduction of 6.6 mm Hg; p-value: 0.012), compared to baseline. Patients who received placebo did not (reduction of 2.1 mm Hg; p-value: ns), compared to baseline. The comparison between those who received relacorilant and placebo was not statistically significant. During the study, 5 patients who received placebo compared to 1 patient who received relacorilant required rescue therapy with anti-hypertension medications. To ensure accuracy, hypertension was measured by 24-hour ambulatory blood pressure monitoring.
GRADIENT patients with hyperglycemia who received relacorilant experienced clinically meaningful and statistically significant improvements at 22 weeks in glucose metabolism, including fasting glucose (placebo-adjusted reduction of 22.2 mg/dL; p-value: 0.002), area under the curve of the oral glucose tolerance test (placebo-adjusted reduction of 2.6 h*mmol/L; p-value: 0.046) and hemoglobin A1c (placebo-adjusted reduction of 0.3 percent; p-value: 0.019), compared to those who received placebo.
Patients in GRADIENT who received relacorilant experienced clinically meaningful and statistically significant improvements at 22 weeks in body weight (placebo-adjusted reduction of 3.9 kg; p-value: 0.0001) and both visceral adipose fat mass and volume (p-values: 0.018 and 0.016, respectively), compared to those who received placebo.
Relacorilant was well tolerated in GRADIENT, with side effects consistent with those seen in its Phase 2 and GRACE trials. Across all of these studies, the most common adverse events were mild-to-moderate nausea, edema, pain in extremities and back, and fatigue – all symptoms associated with the “cortisol withdrawal” many patients experience following surgery or start of medical therapy for Cushing’s syndrome. Importantly, there were no relacorilant-induced instances of hypokalemia, relacorilant-induced endometrial hypertrophy or related vaginal bleeding, adrenal insufficiency or QT prolongation.
Complete results from the GRADIENT trial will be presented at a medical conference next year.
“We are also looking forward to results from the treatment phase of our CATALYST study by year-end,” continued Dr. Guyer. “CATALYST is the largest and most rigorous study ever conducted of hypercortisolism in patients with difficult-to-control diabetes. CATALYST’s prevalence results confirm there are many more patients with Cushing's syndrome than was previously assumed and the trial is poised to be a landmark study in the identification and treatment of patients with hypercortisolism. We are confident it will lead to better health outcomes for many patients who are struggling today.”
Oncology
- ROSELLA – Enrollment completed in pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer; results expected this quarter
-
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
“Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer. 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 data, ROSELLA’s primary endpoint, by the end of this year,” said Dr. Guyer.
Amyotrophic Lateral Sclerosis (ALS)
- DAZALS – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2 trial of dazucorilant in 249 patients with ALS; results expected this quarter
“ALS is a dire disease, with few good treatment options. Our selective cortisol modulator dazucorilant showed great promise in an animal model of ALS, improving motor performance and reducing neuroinflammation and muscular atrophy. We expect data regarding DAZALS’s primary endpoint – improvement in patients’ ALS Functional Rating Scale-Revised (ALSFRS-R) score – by the end of this year. We hope DAZALS will lead to a much-needed advance for patients with ALS,” 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. “Miricorilant has the potential to greatly benefit the millions of patients with MASH.”
Conference Call
We will hold a conference call on October 30, 2024, 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. Additionally, 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 that 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 include, but are not limited to, risks related to the sale and reimbursement of Korlym and our ability to operate our business successfully in a competitive and closely regulated market; risks related to the study and development of Korlym, relacorilant, dazucorilant, miricorilant and our other product candidates, including their clinical attributes and applicable regulatory approvals, mandates, oversight and other government requirements; general litigation risks; and the scope and protective power of our intellectual property. These and other risks 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 revenue growth and 2024 revenue guidance; the development of relacorilant as a treatment for patients with Cushing’s syndrome 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 Cushing’s syndrome; the timing of and expectations regarding our CATALYST, ROSELLA, DAZALS and MONARCH trials and the possibility of relacorilant, dazucorilant and miricorilant being approved for the treatment of any disorder; and the accrual and attributes of our clinical data and the timing and content of our regulatory submissions. 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) |
|||||
|
September 30,
|
|
December 31,
|
||
|
(Unaudited) |
|
|
||
Assets |
|
|
|
||
Cash and investments |
$ |
547,646 |
|
$ |
425,397 |
Trade receivables, net of allowances |
|
59,717 |
|
|
41,123 |
Insurance recovery receivable related to Melucci litigation |
|
— |
|
|
14,000 |
Inventory |
|
15,814 |
|
|
15,974 |
Operating lease right-of-use asset |
|
5,503 |
|
|
120 |
Deferred tax assets, net |
|
126,799 |
|
|
90,605 |
Other assets |
|
28,778 |
|
|
34,298 |
Total assets |
$ |
784,257 |
|
$ |
621,517 |
Liabilities and Stockholders’ Equity |
|
|
|
||
Accounts payable |
$ |
18,584 |
|
$ |
17,396 |
Accrued settlement related to Melucci litigation |
|
— |
|
|
14,000 |
Operating lease liabilities |
|
6,791 |
|
|
151 |
Other liabilities |
|
120,047 |
|
|
83,265 |
Stockholders’ equity |
|
638,835 |
|
|
506,705 |
Total liabilities and stockholders’ equity |
$ |
784,257 |
|
$ |
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 |
|
Nine Months Ended |
||||||||||||
|
September 30, |
|
September 30, |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenues |
|
|
|
|
|
|
|
||||||||
Product revenue, net |
$ |
182,546 |
|
|
$ |
123,601 |
|
|
$ |
493,150 |
|
|
$ |
346,970 |
|
|
|
|
|
|
|
|
|
||||||||
Operating expenses |
|
|
|
|
|
|
|
||||||||
Cost of sales |
|
2,867 |
|
|
|
1,645 |
|
|
|
7,926 |
|
|
|
4,604 |
|
Research and development |
|
59,336 |
|
|
|
45,517 |
|
|
|
176,587 |
|
|
|
129,646 |
|
Selling, general and administrative |
|
73,745 |
|
|
|
45,262 |
|
|
|
196,948 |
|
|
|
137,107 |
|
Total operating expenses |
|
135,948 |
|
|
|
92,424 |
|
|
|
381,461 |
|
|
|
271,357 |
|
Income from operations |
|
46,598 |
|
|
|
31,177 |
|
|
|
111,689 |
|
|
|
75,613 |
|
Interest and other income |
|
6,345 |
|
|
|
5,208 |
|
|
|
17,844 |
|
|
|
12,135 |
|
Income before income taxes |
|
52,943 |
|
|
|
36,385 |
|
|
|
129,533 |
|
|
|
87,748 |
|
Income tax expense |
|
(5,730 |
) |
|
|
(5,007 |
) |
|
|
(19,070 |
) |
|
|
(12,963 |
) |
Net income |
$ |
47,213 |
|
|
$ |
31,378 |
|
|
$ |
110,463 |
|
|
$ |
74,785 |
|
|
|
|
|
|
|
|
|
||||||||
Net income attributable to common stockholders |
$ |
46,690 |
|
|
$ |
31,172 |
|
|
$ |
109,344 |
|
|
$ |
74,353 |
|
|
|
|
|
|
|
|
|
||||||||
Basic net income per common share |
$ |
0.45 |
|
|
$ |
0.31 |
|
|
$ |
1.06 |
|
|
$ |
0.72 |
|
|
|
|
|
|
|
|
|
||||||||
Diluted net income per common share |
$ |
0.41 |
|
|
$ |
0.28 |
|
|
$ |
0.98 |
|
|
$ |
0.66 |
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares outstanding used in computing net income per common share |
|
|
|
|
|
|
|
||||||||
Basic |
|
103,371 |
|
|
|
102,014 |
|
|
|
103,094 |
|
|
|
103,933 |
|
Diluted |
|
113,723 |
|
|
|
111,099 |
|
|
|
111,571 |
|
|
|
112,054 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20241030790123/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
Source: Corcept Therapeutics Incorporated
FAQ
What were Corcept Therapeutics (CORT) Q3 2024 earnings?
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