- Revenue of $182.5 million, a 48 percent increase over the same
period in 2023
- Increase in 2024 revenue guidance to $675 – $700 million, from
$640 – $670 million
- Net income per common share of $0.41 (diluted), compared to
$0.28 in third quarter 2023
- Cash and investments of $547.6 million as of September 30,
2024
- 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
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
September 30, 2024.
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 $182.5 million,
compared to $123.6 million in the third quarter of 2023. Third
quarter operating expenses were $135.9 million, compared to $92.4
million in the third quarter of 2023. Net income was $47.2 million
in the third quarter of 2024, compared to $31.4 million in the same
period last year.
The company increased its 2024 revenue guidance to $675 – $700
million.
Cash and investments were $547.6 million at September 30, 2024,
compared to $492.5 million at June 30, 2024. The balance at
September 30, 2024 reflects the acquisition of $23.4 million of
common stock (870,000 shares) in the third quarter pursuant to the
company’s stock repurchase program, net exercise of employee stock
options and net vesting of restricted stock grants.
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 U.S. Food and Drug
Administration for the treatment of patients with Cushing’s
syndrome. Corcept is headquartered in Redwood City, 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, 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, 2024
December 31, 2023(1)
(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
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