Corcept Therapeutics Announces First Quarter Financial Results and Provides Corporate Update
Corcept Therapeutics Incorporated reported strong financial results for the first quarter of 2024, with a revenue of $146.8 million, a 39% increase from the same period in 2023. The company raised its 2024 revenue guidance to $620 - $650 million and reported a net income per common share of $0.25. Corcept continues to focus on developing medications for various disorders by modulating the effects of cortisol. The company highlighted record numbers of new prescribers and patients for its drug Korlym in the first quarter, showcasing its growing presence in the market.
Revenue of $146.8 million, a 39% increase over the same period in 2023
Net income per common share of $0.25 (diluted), compared to $0.14 in first quarter 2023
Increased 2024 revenue guidance to $620 - $650 million
Record number of new Korlym prescribers and patients in the first quarter
First quarter operating expenses of $117.3 million compared to $90.8 million in 2023 due to increased clinical trial activity
Increase in operating expenses due to clinical trial activity and team expansion
Potential risks associated with increased expenses affecting profitability
Reliance on the success of ongoing clinical trials for future revenue growth
The substantial 39 percent increase in revenue reported by Corcept Therapeutics is a standout figure, demonstrating the company's strong growth trajectory. The revision of revenue guidance upwards from $600 million to between $620 and $650 million further underscores management's confidence in sustained growth and perhaps reflects underlying market dynamics such as increased recognition and treatment of hypercortisolism.
From a financial perspective, the increase in operating expenses to $117.3 million, primarily due to enhanced clinical trial activity and commercial team expansion, indicates strategic reinvestment into the company's core competencies. These investments could potentially generate long-term value for stakeholders, provided that the trials lead to successful drug approvals and subsequent market capture.
Moreover, the reported cash reserves of $451 million offer a cushion for future R&D and commercial endeavors. This financial health metric is important for investors as it suggests a reduced likelihood of needing to raise capital in the short-term, which could dilute shareholder value.
The positive results from the GRACE trial's open-label phase for relacorilant in treating Cushing's syndrome are highly encouraging. The anticipation of results from the randomized withdrawal phase could be a significant inflection point for the company, potentially validating the drug's efficacy and safety profile. The implications are substantial, as Cushing's syndrome, though rare, has a considerable impact on patient quality of life and may represent a niche yet lucrative market.
Completion of enrollment in other late-stage studies, including GRADIENT and CATALYST, signals Corcept's commitment to exploring cortisol modulation across different conditions. The CATALYST trial's finding that approximately 25% of enrolled patients with difficult-to-control diabetes had hypercortisolism, if validated by full results, may open an avenue for repurposing Korlym in a broader patient population, thus expanding its commercial potential.
Corcept's diversified pipeline, with various trials expected to yield data by year-end, positions the company favorably in multiple domains, including oncology and ALS. The potential of relacorilant in combination therapies for cancer and dazucorilant for ALS could cater to significant unmet needs, enhancing the company's market footprint if clinical outcomes are favorable.
MENLO PARK, Calif., May 01, 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 March 31, 2024.
Financial Results
- Revenue of
$146.8 million , a 39 percent increase over the same period in 2023 - Increase in 2024 revenue guidance to
$620 –$650 million , from$600 -$630 million - Net income per common share of
$0.25 (diluted), compared to$0.14 in first quarter 2023 - Cash and investments of
$451.0 million as of March 31, 2024
“There were a record number of new Korlym® prescribers in the first quarter and a record number of patients receiving Korlym. 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. “When Korlym is prescribed, we use the expertise and infrastructure that we have developed and refined over many years to support physicians and patients. This additional care helps create a life-changing impact for patients who receive Korlym treatment.”
Corcept’s first quarter 2024 revenue was
The company increased its 2024 revenue guidance to
Clinical Development
“The results of the open-label phase of our GRACE trial, which we released last week, are compelling,” said Dr. Belanoff. “We expect to build on these results in the trial’s randomized withdrawal phase. Results from this portion of the study will be available in the coming weeks. We are on track to submit our NDA for relacorilant in Cushing’s syndrome by the end of this quarter.
“In addition, we have completed enrollment in all our other late-stage studies – GRADIENT, CATALYST, ROSELLA and DAZALS. We expect that these studies will provide potent evidence that cortisol modulation is a powerful therapeutic mechanism with activity in many serious disorders,” added Dr. Belanoff. “We expect data from these trials by the end of this year.”
Cushing’s Syndrome
- GRACE – Phase 3 trial of relacorilant in patients with all etiologies of hypercortisolism – open-label phase demonstrated clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, waist circumference, cognitive impairment and quality of life; results from randomized withdrawal phase expected this quarter
- Relacorilant New Drug Application (NDA) – NDA submission for Cushing’s syndrome expected this quarter
- GRADIENT – Phase 3 trial of relacorilant in 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; patients with hypercortisolism may enter a randomized, double-blind, placebo-controlled study of Korlym – enrollment completed; preliminary results: approximately
25% of patients enrolled were found to have hypercortisolism; full prevalence phase results expected this quarter and treatment phase results expected by year-end
“Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing’s syndrome. Patients in GRACE’s open-label phase exhibited significant improvements across a broad range of clinically meaningful endpoints, without significant safety burden. All patients have now completed the randomized withdrawal phase of the study. We plan to present data from both the open-label and randomized withdrawal phases of the study at a medical conference in June,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
“Our CATALYST trial is the largest and most rigorous study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. We believe that CATALYST will be a landmark study to guide physicians as they identify and treat patients with hypercortisolism. We will present final results from the prevalence phase at the American Diabetes Association’s 84th Scientific Sessions in June,” said Dr. Guyer.
Oncology
- ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer – enrollment completed; results expected by year-end
- Open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess – enrollment completed; results expected by mid-year
- Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago – enrollment continues
“Fully enrolling ROSELLA takes us a big step closer to addressing the unmet medical need of women with platinum-resistant ovarian cancer. Relacorilant has the potential to become the standard of care for patients with this devastating disease. 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 patients with ALS – enrollment completed; results expected by year-end
“Better treatments for ALS are urgently needed. Dazucorilant showed great promise in an animal model of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. Fully enrolling DAZALS is an important step toward understanding dazucorilant's potential for significantly improving outcomes for people living with this devastating disease. We expect data by the end of this year,” said Dr. Guyer.
Non-alcoholic Steatohepatitis (NASH)
- MONARCH – Randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed NASH – 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. “This drug has the potential to greatly benefit the millions of patients with NASH.”
Conference Call
We will hold a conference call on May 1, 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 across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept’s advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, ALS and NASH. 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 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; 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 NASH; 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) | |||||
| March 31, 2024 | December 31, 2023(1) | ||||
| (Unaudited) | |||||
| Assets | |||||
| Cash and investments | $ | 451,037 | $ | 425,397 | |
| Trade receivables, net of allowances | 61,518 | 41,123 | |||
| Insurance recovery receivable related to Melucci litigation | — | 14,000 | |||
| Inventory | 15,036 | 15,974 | |||
| Operating lease right-of-use asset | 61 | 120 | |||
| Deferred tax assets, net | 97,870 | 90,605 | |||
| Other assets | 30,413 | 34,298 | |||
| Total assets | $ | 655,935 | $ | 621,517 | |
| Liabilities and Stockholders’ Equity | |||||
| Accounts payable | $ | 12,557 | $ | 17,396 | |
| Accrued settlement related to Melucci litigation | — | 14,000 | |||
| Operating lease liabilities | 76 | 151 | |||
| Other liabilities | 95,438 | 83,265 | |||
| Stockholders’ equity | 547,864 | 506,705 | |||
| Total liabilities and stockholders’ equity | $ | 655,935 | $ | 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 | |||||||
| March 31, | |||||||
| 2024 | 2023 | ||||||
| Revenues | |||||||
| Product revenue, net | $ | 146,808 | $ | 105,654 | |||
| Operating expenses | |||||||
| Cost of sales | 2,535 | 1,386 | |||||
| Research and development | 58,505 | 40,851 | |||||
| Selling, general and administrative | 56,268 | 48,564 | |||||
| Total operating expenses | 117,308 | 90,801 | |||||
| Income from operations | 29,500 | 14,853 | |||||
| Interest and other income | 5,493 | 3,581 | |||||
| Income before income taxes | 34,993 | 18,434 | |||||
| Income tax expense | (7,231 | ) | (2,555 | ) | |||
| Net income | $ | 27,762 | $ | 15,879 | |||
| Net income attributable to common stockholders | $ | 27,514 | $ | 15,807 | |||
| Basic net income per common share | $ | 0.27 | $ | 0.15 | |||
| Diluted net income per common share | $ | 0.25 | $ | 0.14 | |||
| Weighted-average shares outstanding used in computing net income per common share | |||||||
| Basic | 102,791 | 107,885 | |||||
| Diluted | 109,915 | 115,425 | |||||
CONTACT:
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
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