Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update
Corcept Therapeutics (NASDAQ: CORT) reported strong Q2 2024 financial results, with revenue of $163.8 million, a 39% increase year-over-year. The company raised its 2024 revenue guidance to $640 – $670 million. Net income per share was $0.32, up from $0.25 in Q2 2023. Cash and investments stood at $492.5 million.
Corcept's clinical development pipeline showed progress, with positive results from the GRACE trial for relacorilant in Cushing's syndrome. The company plans to submit a New Drug Application for relacorilant in Q4. The CATALYST study revealed a 24% prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes. Results from several late-stage trials, including ROSELLA for ovarian cancer and DAZALS for ALS, are expected by year-end.
Corcept Therapeutics (NASDAQ: CORT) ha riportato forti risultati finanziari del Q2 2024, con un fatturato di 163,8 milioni di dollari, un aumento del 39% rispetto all'anno precedente. L'azienda ha alzato le sue previsioni di fatturato per il 2024 a 640 - 670 milioni di dollari. L'utile netto per azione è stato di 0,32 dollari, rispetto a 0,25 dollari nel Q2 2023. La liquidità e gli investimenti ammontavano a 492,5 milioni di dollari.
Il pipeline di sviluppo clinico di Corcept ha mostrato progressi, con risultati positivi dal trial GRACE per relacorilant nella sindrome di Cushing. L'azienda prevede di presentare una Nuova Domanda di Farmaco per relacorilant nel Q4. Lo studio CATALYST ha rivelato una prevalenza del 24% di ipercortisolismo in pazienti con diabete di tipo 2 difficile da controllare. I risultati di diversi trial di fase avanzata, inclusi ROSELLA per il cancro ovarico e DAZALS per l'ALS, sono attesi entro la fine dell'anno.
Corcept Therapeutics (NASDAQ: CORT) informó sobre sólidos resultados financieros del Q2 2024, con ingresos de 163,8 millones de dólares, un aumento del 39% en comparación con el año anterior. La compañía elevó su perspectiva de ingresos para 2024 a entre 640 y 670 millones de dólares. El ingreso neto por acción fue de 0,32 dólares, por encima de 0,25 dólares en el Q2 2023. El efectivo y las inversiones se situaron en 492,5 millones de dólares.
El pipeline de desarrollo clínico de Corcept mostró avances, con resultados positivos del ensayo GRACE para relacorilant en el síndrome de Cushing. La empresa planea presentar una Nueva Solicitud de Medicamento para relacorilant en el Q4. El estudio CATALYST reveló una prevalencia del 24% de hipercortisolismo en pacientes con diabetes tipo 2 de difícil control. Se esperan resultados de varios ensayos de última fase, incluidos ROSELLA para cáncer de ovario y DAZALS para ELA, para finales de año.
Corcept Therapeutics (NASDAQ: CORT)는 2024년 2분기 재무 결과를 보고했으며, 수익은 1억 6,380만 달러로 전년 대비 39% 증가했습니다. 회사는 2024년 수익 가이던스를 6억 4천만 - 6억 7천만 달러로 상향 조정했습니다. 주당 순이익은 0.32달러로, 2023년 2분기의 0.25달러에서 증가했습니다. 현금과 투자 자산은 4억 9,250만 달러에 달했습니다.
Corcept의 임상 개발 파이프라인은 성과를 나타냈으며, 쿠싱 증후군에 대한 relacorilant의 GRACE 시험에서 긍정적인 결과를 보였습니다. 회사는 4분기에 relacorilant에 대한 신약 신청서를 제출할 계획입니다. CATALYST 연구에서는 조절이 어려운 제2형 당뇨병 환자에서 24%의 고코르티솔혈증 유병률이 드러났습니다. 자궁난소암에 대한 ROSELLA와 ALS에 대한 DAZALS를 포함한 여러 후기 단계 시험의 결과는 연말까지 발표될 예정입니다.
Corcept Therapeutics (NASDAQ: CORT) a annoncé de solides résultats financiers pour le Q2 2024, avec un chiffre d'affaires de 163,8 millions de dollars, en hausse de 39 % par rapport à l'année précédente. La société a relevé ses prévisions de revenus pour 2024 à 640 - 670 millions de dollars. Le bénéfice net par action s'élevait à 0,32 dollar, contre 0,25 dollar au Q2 2023. Les liquidités et investissements s'élevaient à 492,5 millions de dollars.
Le pipeline de développement clinique de Corcept a montré des avancées, avec des résultats positifs de l'
Corcept Therapeutics (NASDAQ: CORT) berichtete über starke finanzielle Ergebnisse für Q2 2024 mit Einnahmen von 163,8 Millionen Dollar, was einem Anstieg von 39% im Jahresvergleich entspricht. Das Unternehmen erhöhte seine Umsatzprognose für 2024 auf 640 – 670 Millionen Dollar. Der Nettogewinn je Aktie betrug 0,32 Dollar, ein Anstieg von 0,25 Dollar im Q2 2023. Die liquiden Mittel und Investitionen beliefen sich auf 492,5 Millionen Dollar.
Die klinische Entwicklungspipeline von Corcept zeigte Fortschritte, mit positiven Ergebnissen aus der GRACE-Studie zu relacorilant bei Cushing-Syndrom. Das Unternehmen plant, im Q4 einen Antrag auf ein neues Medikament für relacorilant einzureichen. Die CATALYST-Studie ergab eine 24%ige Prävalenz von Hyperkortisolismus bei Patienten mit schwer kontrollierbarem Typ-2-Diabetes. Die Ergebnisse mehrerer Studien in fortgeschrittenen Phasen, einschließlich ROSELLA für Eierstockkrebs und DAZALS für ALS, werden noch in diesem Jahr erwartet.
- Revenue increased 39% year-over-year to $163.8 million
- 2024 revenue guidance raised to $640 – $670 million
- Net income per share increased to $0.32 from $0.25 in Q2 2023
- Cash and investments grew to $492.5 million
- Positive results from GRACE trial for relacorilant in Cushing's syndrome
- CATALYST study revealed 24% prevalence of hypercortisolism in difficult-to-control diabetes patients
- Operating expenses increased to $128.2 million from $88.1 million in Q2 2023
Insights
Corcept Therapeutics' Q2 2024 results demonstrate robust financial performance and promising clinical developments. The company reported
The financial health of Corcept is further underscored by its net income of
However, it's worth noting that operating expenses have increased to
The positive clinical trial results, particularly from the GRACE study for relacorilant in Cushing's syndrome, could potentially lead to a new drug application in Q4 2024. This, coupled with the CATALYST study results, could significantly expand Corcept's market opportunity in the endocrinology space.
Overall, Corcept's financial performance and clinical progress present a compelling narrative for potential growth, but investors should remain vigilant about the increasing operational costs and the outcomes of pending late-stage clinical trials.
Corcept's clinical development pipeline shows promising advancements across multiple indications. The GRACE trial's positive results for relacorilant in Cushing's syndrome patients are particularly noteworthy. The study demonstrated clinically meaningful improvements in various symptoms, including hypertension, hyperglycemia and cognitive impairment. This positions relacorilant as a potential game-changer in Cushing's syndrome treatment, with an NDA submission expected in Q4 2024.
The CATALYST study's findings are equally intriguing, revealing that
In oncology, the ROSELLA trial for relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer patients could be a major breakthrough if it replicates the positive Phase 2 results. The potential to become a new standard of care in this difficult-to-treat cancer would be a substantial win for Corcept.
The company's expansion into ALS with the DAZALS trial of dazucorilant and MASH with the MONARCH trial of miricorilant demonstrates Corcept's commitment to leveraging its expertise in cortisol modulation across various indications. These studies could open up entirely new markets for the company if successful.
While the clinical pipeline appears robust, it's important to note that many of these trials are in late stages with results expected by year-end. The outcomes of these studies will be critical in determining Corcept's future growth trajectory and market position.
MENLO PARK, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today reported its results for the quarter ended June 30, 2024.
Financial Results
- Revenue of
$163.8 million , a 39 percent increase over the same period in 2023 - Increase in 2024 revenue guidance to
$640 –$670 million , from$620 –$650 million - Net income per common share of
$0.32 (diluted), compared to$0.25 in second quarter 2023 - Cash and investments of
$492.5 million as of June 30, 2024
“Once again, we had a record number of new Korlym® prescribers and a record number of patients receiving Korlym this quarter. Physicians are increasingly aware that hypercortisolism is much more prevalent than was previously assumed, so they are screening more patients for the disorder,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “From the launch of Korlym, we implemented a unique system of patient and physician support and have invested in multiple refinements over the past 12 years. Hypercortisolism is a complicated disease and the expertise we have developed is critical to the life-changing impact for patients who receive Korlym treatment.”
Corcept’s second quarter 2024 revenue was
The company increased its 2024 revenue guidance to
Clinical Development
“During the second quarter we presented the results from our GRACE and CATALYST trials. GRACE’s positive results are a welcome development for patients with hypercortisolism and constitute a significant step toward our new drug application for relacorilant, which we expect to submit in the fourth quarter. In addition, the results from the prevalence phase of our CATALYST study establish that hypercortisolism is a driving biological force in patients with diabetes refractory to treatment. We expect data from the treatment phase of the CATALYST study, as well as our other late-stage studies, GRADIENT, ROSELLA and DAZALS, by the end of this year,” added Dr. Belanoff.
Cushing’s Syndrome
- GRACE – 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 and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognitive impairment and quality of life
- Relacorilant New Drug Application (NDA) – NDA submission for Cushing’s syndrome expected in the fourth quarter
- GRADIENT – Phase 3 trial of relacorilant in 137 patients with Cushing’s syndrome caused by adrenal adenomas – enrollment completed; results expected in the fourth quarter
- CATALYST – Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – in the first 1,055 patients enrolled,
24% were found to have hypercortisolism; 136 patients with hypercortisolism entered a randomized, double-blind, placebo-controlled study of Korlym – treatment phase results expected in the fourth quarter
“Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing’s syndrome. Patients in GRACE’s open-label phase experienced significant improvements across a broad range of clinically meaningful endpoints, without significant safety burden. 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,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
“Our Phase 4 CATALYST trial is the largest and most rigorous study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. The prevalence results from CATALYST confirm there are considerably more patients with Cushing's syndrome than was previously assumed. CATALYST is poised to become the landmark study that guides physicians toward expanded screening for hypercortisolism and will result in better health outcomes for many patients who are struggling today,” said Dr. Guyer.
Oncology
- ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – enrollment completed; results expected in the fourth quarter
- Open-label, Phase 1b trial of relacorilant plus pembrolizumab in 14 patients with advanced adrenal cancer with cortisol excess – improvement in Cushing’s syndrome signs and symptoms observed; no change in tumor progression
- Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago – enrollment continues
“Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer. If our pivotal ROSELLA trial replicates the positive results from our large, controlled, Phase 2 study, it will constitute a major medical advance. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year,” said Dr. Guyer.
Amyotrophic Lateral Sclerosis (ALS)
- DAZALS – Randomized, double-blind, placebo-controlled, Phase 2 trial of dazucorilant in 249 patients with ALS – enrollment completed; results expected in the fourth quarter
“Dazucorilant showed great promise in an animal model of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We expect data by the end of this year and are hopeful that the trial results will create a much-needed advance for patients with ALS,” said Dr. Guyer.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- MONARCH – Randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant with a cohort of patients with biopsy-confirmed MASH and a second cohort of patients with presumed MASH based on non-invasive diagnostic tests – enrollment continues
“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 July 29, 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 U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, California. For more information, visit Corcept.com.
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, our ability to operate our business and generate sufficient revenue to fund our activities; the availability of competing treatments for hypercortisolism, including the potential for rapid uptake or discounted pricing of generic versions of Korlym; our ability to obtain acceptable prices and adequate insurance coverage and reimbursement for Korlym; risks related to the development of Korlym, relacorilant, dazucorilant, miricorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; the timing, cost and outcome of legal disputes and investigations; 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: favorable trends in medical practice, our continued revenue growth and 2024 revenue guidance, which may be adversely affected by changing technology, government pricing regulations and increased uptake or price reductions in competing medications, including generic versions of Korlym; the rates of screening and treatment for hypercortisolism; cortisol modulation’s potential to treat serious diseases; development of relacorilant as a treatment for Cushing’s syndrome and ovarian, adrenal and prostate cancer; the design, timing and expectations regarding our GRACE and GRADIENT trials; the timing and disposition of relacorilant’s NDA in Cushing’s syndrome, including any additional requirements, revisions or delays imposed by the FDA in course of its review; the design, timing and expectations regarding our CATALYST trial; the design, timing and expectations of our ROSELLA trial and the potential for relacorilant plus nab-paclitaxel to become a standard of care; the design, timing and expectations of our DAZALS trial of dazucorilant in patients with ALS; the design, timing and expectations of our MONARCH trial in patients with MASH; and the accrual and attributes of clinical data, as well as the timing of regulatory submissions with respect to, all of our development activities. 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) | |||||
| June 30, 2024 | December 31, 2023(1) | ||||
| (Unaudited) | |||||
| Assets | |||||
| Cash and investments | $ | 492,471 | $ | 425,397 | |
| Trade receivables, net of allowances | 53,837 | 41,123 | |||
| Insurance recovery receivable related to Melucci litigation | — | 14,000 | |||
| Inventory | 16,801 | 15,974 | |||
| Operating lease right-of-use asset | 5,684 | 120 | |||
| Deferred tax assets, net | 111,848 | 90,605 | |||
| Other assets | 33,914 | 34,298 | |||
| Total assets | $ | 714,555 | $ | 621,517 | |
| Liabilities and Stockholders’ Equity | |||||
| Accounts payable | $ | 19,484 | $ | 17,396 | |
| Accrued settlement related to Melucci litigation | — | 14,000 | |||
| Operating lease liabilities | 5,669 | 151 | |||
| Other liabilities | 93,159 | 83,265 | |||
| Stockholders’ equity | 596,243 | 506,705 | |||
| Total liabilities and stockholders’ equity | $ | 714,555 | $ | 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 | Six Months Ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenues | |||||||||||||||
| Product revenue, net | $ | 163,796 | $ | 117,715 | $ | 310,604 | $ | 223,369 | |||||||
| Operating expenses | |||||||||||||||
| Cost of sales | 2,524 | 1,574 | 5,059 | 2,960 | |||||||||||
| Research and development | 58,745 | 43,277 | 117,251 | 84,128 | |||||||||||
| Selling, general and administrative | 66,935 | 43,281 | 123,203 | 91,845 | |||||||||||
| Total operating expenses | 128,204 | 88,132 | 245,513 | 178,933 | |||||||||||
| Income from operations | 35,592 | 29,583 | 65,091 | 44,436 | |||||||||||
| Interest and other income | 6,004 | 3,347 | 11,498 | 6,928 | |||||||||||
| Income before income taxes | 41,596 | 32,930 | 76,589 | 51,364 | |||||||||||
| Income tax expense | (6,108 | ) | (5,402 | ) | (13,339 | ) | (7,957 | ) | |||||||
| Net income | $ | 35,488 | $ | 27,528 | $ | 63,250 | $ | 43,407 | |||||||
| Net income attributable to common stockholders | $ | 35,120 | $ | 27,356 | $ | 62,640 | $ | 43,173 | |||||||
| Basic net income per common share | $ | 0.34 | $ | 0.27 | $ | 0.61 | $ | 0.41 | |||||||
| Diluted net income per common share | $ | 0.32 | $ | 0.25 | $ | 0.57 | $ | 0.38 | |||||||
| Weighted-average shares outstanding used in computing net income per common share | |||||||||||||||
| Basic | 103,118 | 101,964 | 102,954 | 104,908 | |||||||||||
| Diluted | 111,244 | 109,590 | 110,550 | 112,492 | |||||||||||
CONTACT:
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
FAQ
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