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 $146.8
million, compared to $105.7 million in the first quarter of 2023.
First quarter operating expenses were $117.3 million, compared to
$90.8 million in the first quarter of 2023, due to increased
clinical trial activity and expenses to support the expansion of
our commercial team. Net income was $27.8 million in the first
quarter of 2024 compared to $15.9 million in the same period last
year. Cash and investments were $451.0 million at March 31, 2024
compared to $425.4 million at December 31, 2023.
The company increased its 2024 revenue guidance
to $620 – $650 million.
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 INCORPORATEDCONDENSED
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 INCORPORATEDCONDENSED
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.comMedia
inquiries:communications@corcept.com www.corcept.com
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