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 and year ended
December 31, 2023.
Financial Results
-
Fourth quarter revenue of $135.4 million, a 31 percent increase
over the same period in 2022
-
Full year 2023 revenue of $482.4 million, a 20 percent increase
over 2022
-
Reiterated 2024 revenue guidance of $600 – $630 million
-
Fourth quarter net income of $31.4 million, compared to $16.6
million in fourth quarter 2022
-
2023 net income of $106.1 million, compared to $101.4 million in
2022
-
Cash and investments of $425.4 million as of December 31, 2023
“The medical field is increasingly recognizing
that Cushing’s syndrome is much more prevalent than was previously
assumed. Our strong 2023 commercial results reflect that physicians
are more regularly screening for hypercortisolism. The results
demonstrate our ability to support these physicians as they manage
this complex disease. We are confident these trends will continue
and are reiterating our 2024 revenue guidance of $600 – $630
million,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive
Officer.
Corcept’s fourth quarter 2023 revenue was $135.4
million, compared to $103.1 million in the fourth quarter of 2022.
Revenue for the full year was $482.4 million, compared to $401.9
million in 2022.
Diluted net income per common share was $0.28 in
the fourth quarter of 2023, compared to $0.14 in the fourth quarter
of 2022. For the full year, it was $0.94 compared to $0.87 in
2022.
Cash and investments were $425.4 million at
December 31, 2023 compared to $436.6 million at December 31, 2022.
In 2023, Corcept paid $154.5 million to purchase its common stock
in connection with the April 2023 tender offer, the exercise of
employee stock options and vesting of restricted stock grants.
Clinical Development
“Our clinical development programs are advancing
rapidly and will reach important milestones this year. We are
on-track to submit our NDA for relacorilant in Cushing’s syndrome
and will report data from our trials in Cushing’s syndrome (GRACE,
GRADIENT and CATALYST), ovarian cancer (ROSELLA) and ALS (DAZALS),”
added Dr. Belanoff.
Cushing’s Syndrome
- GRACE – Phase 3
trial of relacorilant in patients with all etiologies of
Cushing’s syndrome – results from open label and randomized
withdrawal phases expected in the second quarter
- Relacorilant New
Drug Application (NDA) – NDA submission for Cushing’s syndrome
expected in the second quarter
- GRADIENT – Phase 3
trial of relacorilant in patients with Cushing’s syndrome caused by
adrenal adenomas – enrollment continues; results expected in the
second half of this year
- 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 continues;
preliminary prevalence phase results: 24% prevalence rate in the
first 700 patients enrolled; final results from prevalence and
treatment phases expected by year-end
“We are on-track to submit our relacorilant NDA
in the second quarter. Relacorilant has demonstrated tremendous
promise as a treatment for patients with Cushing’s syndrome and we
are eager to make it more broadly available,” said Bill Guyer,
PharmD, Corcept’s Chief Development Officer.
“Our CATALYST trial 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 stimulate physicians’ efforts to screen for
hypercortisolism in patients with difficult-to-control diabetes and
to treat them when hypercortisolism is found. Almost all of these
patients currently go undiagnosed. We believe that CATALYST will be
a landmark study and look forward to presenting the final results
from the prevalence phase at the American Diabetes Association’s
84th Scientific Sessions in June,” added Dr. Guyer.
Oncology
- ROSELLA – Pivotal
Phase 3 trial of relacorilant plus nab-paclitaxel in patients with
platinum-resistant ovarian cancer – enrollment continues; 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
“If our ROSELLA trial replicates the results of
our Phase 2 trial in patients with platinum-resistant ovarian
cancer (results published in The Journal of Clinical Oncology, June
2023), it will constitute a major medical advance and could
establish the combination of relacorilant and nab-paclitaxel as a
new standard of care for women with this devastating disease. We
expect data from ROSELLA 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 continues; results
expected by year-end
“ALS is a lethal illness with an urgent need for
better treatment. Dazucorilant showed great promise in animal
models of ALS – improving motor performance and reducing
neuroinflammation and muscular atrophy. Our DAZALS study is
investigating dazucorilant’s potential to significantly improve the
lives of patients with ALS. 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
“Miricorilant has the potential to greatly
benefit the millions of patients with NASH. Our Phase 1b study
demonstrated that miricorilant effectively reduces liver fat,
improves liver health and key metabolic and lipid measures and is
well-tolerated. We look forward to building on these promising
results in our MONARCH study,” said Dr. Guyer.
Conference Call
We will hold a conference call on February 15,
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 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 www.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 2024 revenue
guidance; the rates of screening and treatment of hypercortisolism;
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; the design, timing and
expectations regarding our GRACE trial; the timing and outcome of
relacorilant’s NDA in Cushing’s syndrome; the design, timing and
expectations regarding our GRADIENT trial; 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 INCORPORATEDCONDENSED
CONSOLIDATED BALANCE SHEETS(In thousands) |
|
|
December 31, 2023 |
|
December 31, 2022(1) |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash and investments |
$ |
425,397 |
|
$ |
436,619 |
Trade receivables, net of allowances |
|
41,123 |
|
|
31,057 |
Insurance recovery receivable related to Melucci litigation |
|
14,000 |
|
|
14,000 |
Inventory |
|
15,974 |
|
|
17,031 |
Operating lease right-of-use asset |
|
120 |
|
|
1,143 |
Deferred tax assets, net |
|
90,605 |
|
|
61,465 |
Other assets |
|
34,298 |
|
|
22,115 |
Total assets |
$ |
621,517 |
|
$ |
583,430 |
Liabilities and
Stockholders’ Equity |
|
|
|
Accounts payable |
$ |
17,396 |
|
$ |
11,976 |
Accrued settlement related to Melucci litigation |
|
14,000 |
|
|
14,000 |
Operating lease liabilities |
|
151 |
|
|
1,143 |
Other liabilities |
|
83,265 |
|
|
54,469 |
Stockholders’ equity |
|
506,705 |
|
|
501,842 |
Total liabilities and stockholders’ equity |
$ |
621,517 |
|
$ |
583,430 |
|
|
|
|
(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 |
|
Year Ended |
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues |
|
|
|
|
|
|
|
Product revenue, net |
$ |
135,405 |
|
|
$ |
103,056 |
|
|
$ |
482,375 |
|
|
$ |
401,858 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of sales |
|
1,876 |
|
|
|
1,480 |
|
|
|
6,481 |
|
|
|
5,385 |
|
Research and development |
|
54,707 |
|
|
|
36,754 |
|
|
|
184,353 |
|
|
|
130,991 |
|
Selling, general and administrative |
|
47,152 |
|
|
|
42,323 |
|
|
|
184,259 |
|
|
|
152,848 |
|
Settlement expense related to Melucci litigation |
|
— |
|
|
|
14,000 |
|
|
|
— |
|
|
|
14,000 |
|
Insurance recovery related to Melucci litigation |
|
— |
|
|
|
(14,000 |
) |
|
|
— |
|
|
|
(14,000 |
) |
Total operating expenses |
|
103,735 |
|
|
|
80,557 |
|
|
|
375,093 |
|
|
|
289,224 |
|
Income from operations |
|
31,670 |
|
|
|
22,499 |
|
|
|
107,282 |
|
|
|
112,634 |
|
Interest and other income |
|
5,139 |
|
|
|
1,777 |
|
|
|
17,275 |
|
|
|
3,557 |
|
Income before income
taxes |
|
36,809 |
|
|
|
24,276 |
|
|
|
124,557 |
|
|
|
116,191 |
|
Income tax expense |
|
(5,454 |
) |
|
|
(7,675 |
) |
|
|
(18,417 |
) |
|
|
(14,773 |
) |
Net
income |
$ |
31,355 |
|
|
$ |
16,601 |
|
|
$ |
106,140 |
|
|
$ |
101,418 |
|
|
|
|
|
|
|
|
|
Net income
attributable to common stockholders |
$ |
31,138 |
|
|
$ |
16,553 |
|
|
$ |
105,496 |
|
|
$ |
101,288 |
|
|
|
|
|
|
|
|
|
Basic net income per
common share |
$ |
0.30 |
|
|
$ |
0.15 |
|
|
$ |
1.02 |
|
|
$ |
0.95 |
|
|
|
|
|
|
|
|
|
Diluted net income per
common share |
$ |
0.28 |
|
|
$ |
0.14 |
|
|
$ |
0.94 |
|
|
$ |
0.87 |
|
|
|
|
|
|
|
|
|
Weighted-average
shares outstanding used in computing net income per common
share |
|
|
|
|
|
|
|
Basic |
|
102,455 |
|
|
|
107,700 |
|
|
|
103,560 |
|
|
|
106,787 |
|
Diluted |
|
110,886 |
|
|
|
116,328 |
|
|
|
111,742 |
|
|
|
115,966 |
|
|
CONTACT: Investor
inquiries: ir@corcept.com Media
inquiries: Communications@corcept.com www.corcept.com
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