Corcept Therapeutics Incorporated (NASDAQ: CORT), a
commercial-stage company engaged in the discovery and development
of medications to treat severe endocrine, oncology, metabolism and
neurology disorders by modulating the effects of the hormone
cortisol, today reported results for the quarter ended September
30, 2023.
Financial Results
- Revenue of $123.6
million, a 22 percent increase from third quarter 2022
- Increase in 2023
revenue guidance to $470 - $480 million, from $455 - $470
million
- Net income per common share of $0.28
(diluted), compared to $0.30 in third quarter 2022
- Cash and investments of $414.8
million as of September 30, 2023
“Our strong results in the third quarter reflect
returns on our substantial investment in helping physicians to
better recognize and treat hypercortisolism. As screening for
hypercortisolism (Cushing’s syndrome) becomes more common, the
number of patients receiving medical therapy grows. We are
confident this trend will continue. Korlym is an excellent
treatment for patients with Cushing’s syndrome and there are many
eligible patients who have yet to receive it. We are raising our
2023 revenue guidance again, to $470 - $480 million,” said Joseph
K. Belanoff, MD, Corcept’s Chief Executive Officer.
Corcept’s third quarter 2023 revenue was $123.6
million, compared to $101.7 million in the third quarter of 2022.
Third quarter operating expenses were $92.4 million, compared to
$69.8 million in the third quarter of 2022, due to increased
clinical trial activity and expenses to support the expansion of
our clinical development and commercial teams. Net income was $31.4
million in the third quarter of 2023 compared to $34.6 million in
the same period last year.
Cash and investments were $414.8 million at
September 30, 2023 compared to $363.3 million at the end of the
prior quarter.
Clinical Development
“We are also very excited by the potential of
our clinical development programs, with important milestones
approaching. In 2024, we expect to report data from our trials in
Cushing’s syndrome (the GRACE, GRADIENT and CATALYST studies),
ovarian cancer (ROSELLA) and ALS (DAZALS). We also plan to submit
an NDA for relacorilant in Cushing’s syndrome and to complete
enrollment of our Phase 2b MONARCH study in patients with NASH,”
added Dr. Belanoff.
Cushing’s
Syndrome
- GRACE – Phase 3
trial of relacorilant as a treatment for patients with all
etiologies of Cushing’s syndrome – enrollment completed; new drug
application (NDA) submission expected in the second quarter of
2024
- GRADIENT – Phase 3
trial of relacorilant as a treatment for patients with Cushing’s
syndrome caused by adrenal adenomas – continues enrollment; results
expected in mid-2024
- 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 – continues enrollment;
prevalence phase results expected in first quarter of 2024 and full
results by year-end 2024
“Relacorilant has tremendous promise as a
treatment for patients with Cushing’s syndrome and we are eager to
make it available,” said Bill Guyer, PharmD, Corcept’s Chief
Development Officer. “Additionally, our CATALYST trial has the
potential to serve as a landmark study to guide physician’s
understanding of Cushing’s syndrome. CATALYST is the largest study
ever conducted to establish the prevalence of hypercortisolism in
patients with difficult-to-control diabetes. We expect CATALYST’s
findings to greatly enhance physicians’ ability to diagnose and
treat the many patients with Cushing’s syndrome whose condition now
frequently goes undiagnosed. We expect data from the prevalence
phase of the CATALYST study by early next year.”
Oncology
- ROSELLA –
360-patient pivotal Phase 3 trial of relacorilant plus
nab-paclitaxel in patients with recurrent, platinum-resistant
ovarian cancer – continues enrollment; results expected by year-end
2024
- Open-label, Phase
1b trial of relacorilant plus pembrolizumab in patients with
adrenal cancer with cortisol excess – continues enrollment; results
expected in early 2024
- Randomized,
placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide
in patients with prostate cancer – initiated in collaboration with
the University of Chicago
“Our Phase 2 trial demonstrated the potential of
relacorilant combined with nab-paclitaxel to become a new standard
of care for the treatment of patients with platinum-resistant
ovarian cancer. The results were published in June in The Journal
of Clinical Oncology. Our pivotal ROSELLA trial aims to replicate
those results. We expect data by the end of next year,” said Dr.
Guyer.
Amyotrophic Lateral Sclerosis
(ALS)
- DAZALS –
198-patient, randomized, double-blind, placebo-controlled, Phase 2
trial of dazucorilant in patients with ALS – continues enrollment;
results expected by year-end 2024
“ALS, also known as Lou Gehrig’s disease, is a
devastating illness with an urgent need for better
treatment. We are conducting our DAZALS study at sites in
Europe and the United States to investigate dazucorilant’s
potential to significantly improve the lives of patients with ALS.
We expect data from this study by the end of next year,” said Dr.
Guyer.
Non-alcoholic Steatohepatitis
(NASH)
- MONARCH – 150-patient, randomized,
double-blind, placebo-controlled, Phase 2b trial of miricorilant in
patients with biopsy-confirmed NASH – initiated in October
2023
“We intend MONARCH to build on the promising
results of our Phase 1b study, which demonstrated that miricorilant
effectively reduces liver fat, improves liver health and key
metabolic and lipid measures and is well-tolerated. Miricorilant
has the potential to greatly benefit the millions of patients with
NASH. We look forward to sharing our Phase 1b results and more
details about MONARCH at a medical conference this fall,” said Dr.
Guyer.
Conference Call
We will hold a conference call on November 1,
2023, 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 www.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; generate sufficient revenue to fund our
activities; the availability of competing treatments for
hypercortisolism, including 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: our continued revenue growth and 2023 revenue
guidance; cortisol modulation’s potential to treat many serious
diseases; development of relacorilant as a treatment for Cushing’s
syndrome and ovarian, adrenal and prostate cancer; expectations
regarding the GRACE trial; the timing and outcome of relacorilant’s
NDA in Cushing’s syndrome; the design, timing and expectations
regarding our CATALYST trial; the timing and expectations of our
ROSELLA trial and the potential for relacorilant plus
nab-paclitaxel to become a standard of care; the timing and
expectations of our DAZALS trial of dazucorilant in patients with
ALS; the timing and substance of our MONARCH trial in patients with
NASH, and the pace of enrollment, study design and timelines, 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)
|
September 30, 2023 |
|
December 31, 2022(1) |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash and investments |
$ |
414,846 |
|
$ |
436,619 |
Trade receivables, net of allowances |
|
34,626 |
|
|
31,057 |
Insurance recovery receivable related to Melucci litigation |
|
14,000 |
|
|
14,000 |
Inventory |
|
16,265 |
|
|
17,031 |
Operating lease right-of-use asset |
|
178 |
|
|
1,143 |
Deferred tax assets, net |
|
87,102 |
|
|
61,465 |
Other assets |
|
27,005 |
|
|
22,115 |
Total assets |
$ |
594,022 |
|
$ |
583,430 |
Liabilities and
Stockholders’ Equity |
|
|
|
Accounts payable |
$ |
16,710 |
|
$ |
11,976 |
Accrued settlement related to Melucci litigation |
|
14,000 |
|
|
14,000 |
Operating lease liabilities |
|
225 |
|
|
1,143 |
Other liabilities |
|
101,408 |
|
|
54,469 |
Stockholders’ equity |
|
461,679 |
|
|
501,842 |
Total liabilities and stockholders’ equity |
$ |
594,022 |
|
$ |
583,430 |
|
|
|
|
(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, |
|
|
2023 |
|
|
|
2022 |
|
|
2023 |
|
|
|
2022 |
|
Revenues |
|
|
|
|
|
|
|
Product revenue, net |
$ |
123,601 |
|
|
$ |
101,728 |
|
$ |
346,970 |
|
|
$ |
298,802 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of sales |
|
1,645 |
|
|
|
1,339 |
|
|
4,604 |
|
|
|
3,905 |
|
Research and development |
|
45,517 |
|
|
|
33,292 |
|
|
129,646 |
|
|
|
94,237 |
|
Selling, general and administrative |
|
45,262 |
|
|
|
35,163 |
|
|
137,107 |
|
|
|
110,525 |
|
Total operating expenses |
|
92,424 |
|
|
|
69,794 |
|
|
271,357 |
|
|
|
208,667 |
|
Income from operations |
|
31,177 |
|
|
|
31,934 |
|
|
75,613 |
|
|
|
90,135 |
|
Interest and other income |
|
5,208 |
|
|
|
1,070 |
|
|
12,135 |
|
|
|
1,780 |
|
Income before income
taxes |
|
36,385 |
|
|
|
33,004 |
|
|
87,748 |
|
|
|
91,915 |
|
Income tax (expense)
benefit |
|
(5,007 |
) |
|
|
1,604 |
|
|
(12,963 |
) |
|
|
(7,098 |
) |
Net
income |
$ |
31,378 |
|
|
$ |
34,608 |
|
$ |
74,785 |
|
|
$ |
84,817 |
|
|
|
|
|
|
|
|
|
Net income
attributable to common stockholders |
$ |
31,172 |
|
|
$ |
34,550 |
|
$ |
74,353 |
|
|
$ |
84,755 |
|
|
|
|
|
|
|
|
|
Basic net income per
common share |
$ |
0.31 |
|
|
$ |
0.32 |
|
$ |
0.72 |
|
|
$ |
0.80 |
|
|
|
|
|
|
|
|
|
Diluted net income per
common share |
$ |
0.28 |
|
|
$ |
0.30 |
|
$ |
0.66 |
|
|
$ |
0.73 |
|
|
|
|
|
|
|
|
|
Weighted-average
shares outstanding used in computing net income per common
share |
|
|
|
|
|
|
|
Basic |
|
102,014 |
|
|
|
107,125 |
|
|
103,933 |
|
|
|
106,479 |
|
Diluted |
|
111,099 |
|
|
|
116,620 |
|
|
112,054 |
|
|
|
115,818 |
|
CONTACT:Investor inquiries:ir@corcept.comMedia
inquiries:CorceptCommunications@corcept.com www.corcept.com
Grafico Azioni Corcept Therapeutics (NASDAQ:CORT)
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Grafico Azioni Corcept Therapeutics (NASDAQ:CORT)
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