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 June 30,
2023.
Financial Results
- Revenue of $117.7
million, a 14 percent increase from second quarter 2022
- Increase in 2023
revenue guidance to $455 - $470 million, from $435 - $455
million
- Net income per common share of $0.25
(diluted), compared to $0.24 in second quarter 2022
- Cash and investments of $363.3
million as of June 30, 2023
- Purchase of 6.6 million shares of
Corcept common stock for $145.4 million
“The strong results of our commercial business
in the second quarter reflect the early returns on our substantial
investment to help improve the ability of physicians to recognize
and treat hypercortisolism. 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 confident in the growth
potential of our Cushing’s syndrome business and are raising our
2023 revenue guidance again, to $455 - $470 million,” said Joseph
K. Belanoff, MD, Corcept’s Chief Executive Officer.
Corcept’s second quarter 2023 revenue was $117.7
million, compared to $103.4 million in the second quarter of 2022.
Second quarter operating expenses were $88.1 million, compared to
$72.0 million in the second quarter of 2022, due to increased
spending on our development programs and to support the expansion
of our clinical development and commercial teams. Net income was
$27.5 million in the second quarter of 2023 compared to $27.4
million in the same period last year.
Cash and investments were $363.3 million at June
30, 2023 compared to $465.1 million at March 31, 2023. In April
2023, Corcept purchased 6.6 million shares of its common stock for
$145.4 million.
Clinical Development
“We are also very excited by the potential of
our clinical development programs. In the next twelve months we
expect data from our GRACE, GRADIENT and CATALYST studies,
submission of an NDA for relacorilant in Cushing’s syndrome,
completion of enrollment of our ROSELLA and DAZALS studies and
initiation of a Phase 2b trial of miricorilant in patients with
NASH,” added Dr. Belanoff.
Cushing’s Syndrome
- Enrollment
completed in Phase 3 GRACE trial of relacorilant as a treatment for
patients with all etiologies of Cushing’s syndrome – new drug
application (NDA) submission expected in the second quarter of
2024
- Enrollment nears
completion in Phase 3 GRADIENT trial of relacorilant as a treatment
for patients with Cushing’s syndrome caused by adrenal
adenomas
- Enrollment
continues in CATALYST – 1,000-patient 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
“With enrollment in GRACE complete, we are
focused on finishing the trial and preparing our NDA. Relacorilant
has tremendous promise as a treatment for patients with all types
of Cushing’s syndrome and we are eager to make it available. Our
GRADIENT trial will produce valuable data about an etiology of
Cushing’s syndrome that affects many patients whose
hypercortisolism frequently goes undiagnosed and untreated,” said
Bill Guyer, PharmD, Corcept’s Chief Development Officer.
“Additionally, we are very excited that our
CATALYST trial is progressing ahead of schedule. CATALYST is the
largest study ever conducted to establish the prevalence of
hypercortisolism in patients with difficult-to-control diabetes. We
expect that it will further enable physicians to identify and
provide effective treatment for a substantial group of patients
with Cushing’s syndrome, whose condition, in most cases, now goes
undiagnosed. We have received very positive feedback from leading
endocrinologists regarding this study and expect to complete
enrollment in the fourth quarter,” added Dr. Guyer.
Oncology
- Enrollment
continues in ROSELLA – 360-patient pivotal Phase 3 trial of
relacorilant plus nab-paclitaxel in patients with recurrent,
platinum-resistant ovarian cancer
- Enrollment
continues in open-label, Phase 1b trial of relacorilant plus
pembrolizumab in patients with adrenal cancer with cortisol
excess
- Randomized,
placebo-controlled Phase 2 trial of relacorilant plus enzalutamide
in patients with prostate cancer, in collaboration with the
University of Chicago, expected to begin in the third quarter
“Relacorilant combined with nab-paclitaxel has
the potential to become a new standard of care for the treatment of
patients with platinum-resistant ovarian cancer. The results of our
positive Phase 2 trial were recently published in the prestigious
Journal of Clinical Oncology. Our pivotal ROSELLA trial aims to
replicate those results. We are on track to complete enrollment by
the end of this year,” said Dr. Guyer.
Amyotrophic Lateral Sclerosis
(ALS)
- Enrollment
continues in DAZALS – 198-patient, randomized, double-blind,
placebo-controlled Phase 2 trial of dazucorilant in patients with
ALS
“We are conducting our DAZALS study in
collaboration with TRICALS, the leading ALS academic consortium in
Europe, to investigate dazucorilant’s potential to significantly
improve the lives of patients with ALS. We recently added clinical
trial sites in the United States and are on track to complete
enrollment by early 2024,” said Dr. Guyer.
Non-alcoholic Steatohepatitis
(NASH)
- Enrollment continues in Phase 1b trial
of miricorilant in patients with presumed NASH – Phase 2b trial to
begin in the fourth quarter
“Miricorilant, a potent, oral, selective
cortisol modulator with targeted activity in the liver, continues
to demonstrate great promise as a treatment for NASH. Our Phase 1b
study has identified a dosing regimen that effectively reduced
liver fat, improved liver health and key metabolic and lipid
measures and was well-tolerated. We plan to start a Phase 2b trial
in the fourth quarter,” said Dr. Guyer.
Conference Call
We will hold a conference call on August 2,
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.
Hypercortisolism
Hypercortisolism, often referred to as Cushing’s
syndrome, is caused by excessive activity of the hormone cortisol.
Endogenous Cushing’s syndrome is an orphan disease that most often
affects adults aged 20-50. In the United States, an estimated
20,000 patients have Cushing’s syndrome, with about 3,000 new
patients diagnosed each year. Symptoms vary, but most patients
experience one or more of the following manifestations: high blood
sugar, diabetes, high blood pressure, upper-body obesity, rounded
face, increased fat around the neck, thinning arms and legs, severe
fatigue and weak muscles. Irritability, anxiety, cognitive
disturbances and depression are also common. Hypercortisolism can
affect every organ system and can be lethal if not treated
effectively. Corcept holds patents directed to the composition of
relacorilant and the use of cortisol modulators, including Korlym,
in the treatment of patients with hypercortisolism.
About Corcept Therapeutics
Corcept has discovered a large portfolio of
proprietary compounds that selectively modulate the effects of
cortisol and owns extensive United States and foreign intellectual
property covering both their composition and their use to treat a
variety of serious disorders. Clinical trials are being conducted
with the company’s leading selective cortisol modulators as
potential treatments for patients with serious disorders –
Cushing’s syndrome, ovarian, prostate and adrenal cancer, ALS,
post-traumatic stress disorder and liver disease. Corcept’s drug
Korlym® was the first medication approved by the U.S. Food and Drug
Administration for the treatment of patients with Cushing’s
syndrome.
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, conduct our clinical trials and achieve our
other goals during the COVID-19 pandemic and 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 our 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, among others: our continued revenue growth and
2023 revenue guidance; the number of eligible patients who have yet
to receive Korlym; 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,
including relacorilant’s clinical attributes, regulatory approvals,
mandates, oversight and other requirements; expectations regarding
the GRACE trial as the basis for relacorilant’s NDA in Cushing’s
syndrome; the design, timing and expectations regarding our
CATALYST trial; the timing and expectations of our ROSELLA trial of
relacorilant plus nab-paclitaxel in patients with recurrent
platinum-resistant ovarian cancer and the potential for
relacorilant plus nab-paclitaxel to become a standard of care for
these patients; the timing and expectations of our DAZALS trial of
dazucorilant in patients with ALS; the timing and substance of our
Phase 1b trial and planned Phase 2b trial in patients with NASH;
our other pre-clinical and clinical development programs, including
the pace of enrollment, study design and timelines, and the accrual
and attributes of clinical data; and the timing of 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) |
|
|
June 30, 2023 |
|
December 31, 2022(1) |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash and investments |
$ |
363,262 |
|
$ |
436,619 |
Trade receivables, net of allowances |
|
32,553 |
|
|
31,057 |
Insurance recovery receivable related to Melucci litigation |
|
14,000 |
|
|
14,000 |
Inventory |
|
15,677 |
|
|
17,031 |
Operating lease right-of-use asset |
|
235 |
|
|
1,143 |
Deferred tax assets, net |
|
78,214 |
|
|
61,465 |
Other assets |
|
20,684 |
|
|
22,115 |
Total assets |
$ |
524,625 |
|
$ |
583,430 |
Liabilities and
Stockholders’ Equity |
|
|
|
Accounts payable |
$ |
7,976 |
|
$ |
11,976 |
Accrued settlement related to Melucci litigation |
|
14,000 |
|
|
14,000 |
Operating lease liabilities |
|
297 |
|
|
1,143 |
Other liabilities |
|
80,738 |
|
|
54,469 |
Stockholders’ equity |
|
421,614 |
|
|
501,842 |
Total liabilities and stockholders’ equity |
$ |
524,625 |
|
$ |
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 |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues |
|
|
|
|
|
|
|
Product revenue, net |
$ |
117,715 |
|
|
$ |
103,386 |
|
|
$ |
223,369 |
|
|
$ |
197,074 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of sales |
|
1,574 |
|
|
|
1,316 |
|
|
|
2,960 |
|
|
|
2,566 |
|
Research and development |
|
43,277 |
|
|
|
32,825 |
|
|
|
84,128 |
|
|
|
60,945 |
|
Selling, general and administrative |
|
43,281 |
|
|
|
37,813 |
|
|
|
91,845 |
|
|
|
75,362 |
|
Total operating expenses |
|
88,132 |
|
|
|
71,954 |
|
|
|
178,933 |
|
|
|
138,873 |
|
Income from operations |
|
29,583 |
|
|
|
31,432 |
|
|
|
44,436 |
|
|
|
58,201 |
|
Interest and other income |
|
3,347 |
|
|
|
630 |
|
|
|
6,928 |
|
|
|
710 |
|
Income before income
taxes |
|
32,930 |
|
|
|
32,062 |
|
|
|
51,364 |
|
|
|
58,911 |
|
Income tax expense |
|
(5,402 |
) |
|
|
(4,650 |
) |
|
|
(7,957 |
) |
|
|
(8,702 |
) |
Net
income |
$ |
27,528 |
|
|
$ |
27,412 |
|
|
$ |
43,407 |
|
|
$ |
50,209 |
|
|
|
|
|
|
|
|
|
Net income
attributable to common stockholders |
$ |
27,356 |
|
|
$ |
27,398 |
|
|
$ |
43,173 |
|
|
$ |
50,196 |
|
|
|
|
|
|
|
|
|
Basic net income per
common share |
$ |
0.27 |
|
|
$ |
0.26 |
|
|
$ |
0.41 |
|
|
$ |
0.47 |
|
|
|
|
|
|
|
|
|
Diluted net income per
common share |
$ |
0.25 |
|
|
$ |
0.24 |
|
|
$ |
0.38 |
|
|
$ |
0.44 |
|
|
|
|
|
|
|
|
|
Weighted-average
shares outstanding used in computing net income per common
share |
|
|
|
|
|
|
|
Basic |
|
101,964 |
|
|
|
106,289 |
|
|
|
104,908 |
|
|
|
106,151 |
|
Diluted |
|
109,590 |
|
|
|
115,399 |
|
|
|
112,492 |
|
|
|
115,222 |
|
CONTACT:Corcept TherapeuticsFor
Investor inquiries:ir@corcept.comFor Media
inquiries:CorceptCommunications@corcept.comwww.corcept.com
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