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 June 30,
2024.
Financial Results
- Revenue of $163.8
million, a 39 percent increase over the same period in 2023
- Increase in 2024
revenue guidance to $640 – $670 million, from $620 – $650
million
- Net income per
common share of $0.32 (diluted), compared to $0.25 in second
quarter 2023
- Cash and investments
of $492.5 million as of June 30, 2024
“Once again, we had a record number of new
Korlym® prescribers and a record number of patients receiving
Korlym this quarter. 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.
“From the launch of Korlym, we implemented a unique system of
patient and physician support and have invested in multiple
refinements over the past 12 years. Hypercortisolism is a
complicated disease and the expertise we have developed is critical
to the life-changing impact for patients who receive Korlym
treatment.”
Corcept’s second quarter 2024 revenue was $163.8
million, compared to $117.7 million in the second quarter of 2023.
Second quarter operating expenses were $128.2 million, compared to
$88.1 million in the second quarter of 2023, due to increased
spending on clinical trials and sales and marketing activities and
to support the expansion of our commercial and clinical development
teams. Net income was $35.5 million in the second quarter of 2024
compared to $27.5 million in the same period last year. Cash and
investments were $492.5 million at June 30, 2024 compared to $451.0
million at March 31, 2024.
The company increased its 2024 revenue guidance
to $640 – $670 million.
Clinical Development
“During the second quarter we presented the
results from our GRACE and CATALYST trials. GRACE’s positive
results are a welcome development for patients with
hypercortisolism and constitute a significant step toward our new
drug application for relacorilant, which we expect to
submit in the fourth quarter. In addition, the results from
the prevalence phase of our CATALYST study establish that
hypercortisolism is a driving biological force in patients with
diabetes refractory to treatment. We expect data from the treatment
phase of the CATALYST study, as well as our other late-stage
studies, GRADIENT, ROSELLA and DAZALS, by the end of this year,”
added Dr. Belanoff.
Cushing’s Syndrome
- GRACE – Phase 3
trial of relacorilant in 152 patients with all etiologies of
hypercortisolism – primary endpoint achieved in randomized
withdrawal phase; open-label phase demonstrated clinically
meaningful and statistically significant improvements in
hypertension, hyperglycemia, weight, lean muscle mass, waist
circumference, cognitive impairment and quality of life
- Relacorilant New
Drug Application (NDA) – NDA submission for Cushing’s syndrome
expected in the fourth quarter
- GRADIENT – Phase 3
trial of relacorilant in 137 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 – in the first 1,055 patients
enrolled, 24% were found to have hypercortisolism; 136 patients
with hypercortisolism entered a randomized, double-blind,
placebo-controlled study of Korlym – treatment phase results
expected in the fourth quarter
“Relacorilant has demonstrated tremendous
promise as a treatment for patients with Cushing’s syndrome.
Patients in GRACE’s open-label phase experienced significant
improvements across a broad range of clinically meaningful
endpoints, without significant safety burden. 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,” said
Bill Guyer, PharmD, Corcept’s Chief Development Officer.
“Our Phase 4 CATALYST trial is the largest and
most rigorous study ever conducted to establish the prevalence of
hypercortisolism in patients with difficult-to-control diabetes.
The prevalence results from CATALYST confirm there are considerably
more patients with Cushing's syndrome than was previously assumed.
CATALYST is poised to become the landmark study that guides
physicians toward expanded screening for hypercortisolism and will
result in better health outcomes for many patients who are
struggling today,” said Dr. Guyer.
Oncology
- ROSELLA – Pivotal
Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients
with platinum-resistant ovarian cancer – enrollment completed;
results expected in the fourth quarter
- Open-label, Phase
1b trial of relacorilant plus pembrolizumab in 14 patients with
advanced adrenal cancer with cortisol excess – improvement in
Cushing’s syndrome signs and symptoms observed; no change in tumor
progression
- Randomized,
placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide
in patients with prostate cancer in collaboration with the
University of Chicago – enrollment continues
“Relacorilant has the potential to become the
standard of care for patients with platinum-resistant ovarian
cancer. If our pivotal ROSELLA trial replicates the positive
results from our large, controlled, Phase 2 study, it will
constitute a major medical advance. 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 249 patients with ALS – enrollment completed;
results expected in the fourth quarter
“Dazucorilant showed great promise in an animal
model of ALS – improving motor performance and reducing
neuroinflammation and muscular atrophy. We expect data by the end
of this year and are hopeful that the trial results will create a
much-needed advance for patients with ALS,” said Dr. Guyer.
Metabolic Dysfunction-Associated
Steatohepatitis (MASH)
- MONARCH – Randomized, double-blind,
placebo-controlled, Phase 2b trial of miricorilant with a cohort of
patients with biopsy-confirmed MASH and a second cohort of patients
with presumed MASH based on non-invasive diagnostic tests –
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.
“Miricorilant has the potential to greatly benefit the millions of
patients with MASH.”
Conference Call
We will hold a conference call on July 29, 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 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
Korlym, 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, including any
additional requirements, revisions or delays imposed by the FDA in
course of its review; 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 MASH; 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) |
|
June 30, 2024 |
|
December 31, 2023(1) |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash and investments |
$ |
492,471 |
|
$ |
425,397 |
Trade receivables, net of allowances |
|
53,837 |
|
|
41,123 |
Insurance recovery receivable related to Melucci litigation |
|
— |
|
|
14,000 |
Inventory |
|
16,801 |
|
|
15,974 |
Operating lease right-of-use asset |
|
5,684 |
|
|
120 |
Deferred tax assets, net |
|
111,848 |
|
|
90,605 |
Other assets |
|
33,914 |
|
|
34,298 |
Total assets |
$ |
714,555 |
|
$ |
621,517 |
Liabilities and
Stockholders’ Equity |
|
|
|
Accounts payable |
$ |
19,484 |
|
$ |
17,396 |
Accrued settlement related to Melucci litigation |
|
— |
|
|
14,000 |
Operating lease liabilities |
|
5,669 |
|
|
151 |
Other liabilities |
|
93,159 |
|
|
83,265 |
Stockholders’ equity |
|
596,243 |
|
|
506,705 |
Total liabilities and stockholders’ equity |
$ |
714,555 |
|
$ |
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 |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenues |
|
|
|
|
|
|
|
Product revenue, net |
$ |
163,796 |
|
|
$ |
117,715 |
|
|
$ |
310,604 |
|
|
$ |
223,369 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of sales |
|
2,524 |
|
|
|
1,574 |
|
|
|
5,059 |
|
|
|
2,960 |
|
Research and development |
|
58,745 |
|
|
|
43,277 |
|
|
|
117,251 |
|
|
|
84,128 |
|
Selling, general and administrative |
|
66,935 |
|
|
|
43,281 |
|
|
|
123,203 |
|
|
|
91,845 |
|
Total operating expenses |
|
128,204 |
|
|
|
88,132 |
|
|
|
245,513 |
|
|
|
178,933 |
|
Income from operations |
|
35,592 |
|
|
|
29,583 |
|
|
|
65,091 |
|
|
|
44,436 |
|
Interest and other income |
|
6,004 |
|
|
|
3,347 |
|
|
|
11,498 |
|
|
|
6,928 |
|
Income before income
taxes |
|
41,596 |
|
|
|
32,930 |
|
|
|
76,589 |
|
|
|
51,364 |
|
Income tax expense |
|
(6,108 |
) |
|
|
(5,402 |
) |
|
|
(13,339 |
) |
|
|
(7,957 |
) |
Net
income |
$ |
35,488 |
|
|
$ |
27,528 |
|
|
$ |
63,250 |
|
|
$ |
43,407 |
|
|
|
|
|
|
|
|
|
Net income
attributable to common stockholders |
$ |
35,120 |
|
|
$ |
27,356 |
|
|
$ |
62,640 |
|
|
$ |
43,173 |
|
|
|
|
|
|
|
|
|
Basic net income per
common share |
$ |
0.34 |
|
|
$ |
0.27 |
|
|
$ |
0.61 |
|
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
Diluted net income per
common share |
$ |
0.32 |
|
|
$ |
0.25 |
|
|
$ |
0.57 |
|
|
$ |
0.38 |
|
|
|
|
|
|
|
|
|
Weighted-average
shares outstanding used in computing net income per common
share |
|
|
|
|
|
|
|
Basic |
|
103,118 |
|
|
|
101,964 |
|
|
|
102,954 |
|
|
|
104,908 |
|
Diluted |
|
111,244 |
|
|
|
109,590 |
|
|
|
110,550 |
|
|
|
112,492 |
|
CONTACT:Investor inquiries:ir@corcept.comMedia
inquiries:communications@corcept.com www.corcept.com
Corcept Therapeutics (NASDAQ:CORT)
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