Corcept Therapeutics Announces Fourth Quarter, Full Year 2013 Revenue and
Provides 2014 Outlook
MENLO PARK, CA -- (Marketwired) -- 01/30/14 -- Corcept Therapeutics
Incorporated (NASDAQ: CORT)
-- Fourth quarter 2013 revenue up 56% over third quarter 2013 revenue
-- Company anticipates Korlym 2014 revenue to grow to a range of $24
million to $28 million, up from $10.4 million in 2013
-- Multiple clinical and regulatory milestones expected during 2014
Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical
company engaged in the discovery, development and commercialization
of drugs for the treatment of severe metabolic, psychiatric and
oncologic disorders, today reported its unaudited net revenue for the
quarter and year ended December 31, 2013 and cash balance as of that
date. The company also provided an overview of the clinical and
regulatory milestones expected during 2014.
Corcept reported estimated net revenue of $4.1 million for the fourth
quarter of 2013 and $10.4 million for the full year. The company's
estimated cash and cash equivalents were $54.9 million at year-end.
Audited results will be available when the company files its Annual
Report on Form 10-K with the Securities and Exchange Commission.
The company estimates 2014 net revenue will be between $24 and $28
"Korlym(R) revenue increased 56 percent in the fourth quarter
compared to the prior quarter," said Joseph K. Belanoff, MD,
Corcept's Chief Executive Officer. "We expect our momentum to
continue in 2014, with Korlym revenue reaching the $24 million to $28
million range for the year."
"We have also made progress toward our other goals and are expecting
significant developments in 2014," Dr. Belanoff continued. "We expect
in the next few days to begin enrolling patients in our study of
mifepristone as a treatment for triple-negative breast cancer. This
study grew out of our work with researchers at the University of
Chicago. We have many other collaborations with academic researchers
exploring the basic science and possible clinical use of mifepristone
(Korlym's active ingredient) in a wide range of indications. While it
is too early to tell whether these investigations will bear fruit, we
are pleased that the medical community is exploring the potential use
of our drug in diseases as varied as alcoholism, post-traumatic
stress disorder and other forms of cancer."
"We will have interim results from our Phase 3 trial of Korlym for
the treatment of psychotic depression in the second quarter of 2014,"
added Dr. Belanoff. "And in the latter part of the year we expect
that two of our novel, selective GR antagonists will enter the
-- Produce Korlym revenue of between $24 and $28 million.
-- Release positive interim results of our study of Korlym in the
treatment of psychotic depression in the second quarter, leading to an
NDA submission by year end.
-- Enroll sufficient patients in our Phase 1 study of mifepristone in
combination with chemotherapy for the treatment of triple-negative
breast cancer to present initial results in the first half of 2015.
-- Advance two of our next-generation selective GR antagonists to the
clinic in the second half of the year.
"In 2013, we focused on building our Cushing's syndrome business as we
addressed our other strategic priorities," said Dr. Belanoff. "We
look forward to an exciting year in 2014. Successful
commercialization of Korlym will remain a key objective while we
continue to develop mifepristone for the treatment of psychotic
depression and triple negative breast cancer. We also plan to advance
our novel, selective GR antagonists to the clinic this year,
potentially for the treatment of patients with Cushing's syndrome,
psychotic depression or triple-negative breast cancer."
Corcept will hold a conference call on January 30, 2014, at 5:00 p.m.
Eastern Time (2:00 p.m. Pacific Time) to discuss this announcement.
To participate, dial 1-888-771-4371 from the United States or
1-847-585-4405 internationally approximately ten minutes before the
start of the call. The passcode is 36540064.
A replay will be available through February 13, 2014 at
1-888-843-7419 from the United States and +1- 630-652-3042
internationally. The passcode is 3654 0064.
About Cushing's Syndrome
Endogenous Cushing's syndrome is caused by prolonged exposure of the
body's tissues to high levels of the hormone cortisol and is
generated by tumors that produce cortisol or ACTH. Cushing's syndrome
is an orphan indication that most commonly affects adults aged 20-50.
An estimated 10-15 of every one million people are newly diagnosed
with this syndrome each year, resulting in over 3,000 new patients
annually in the United States. An estimated 20,000 patients in the
United States have Cushing's syndrome. Symptoms vary, but most people
have 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. Cushing's syndrome can affect every organ
system in the body and can be lethal if not treated effectively.
Korlym blocks the glucocorticoid receptor type II (GR) to which
cortisol normally binds, thereby inhibiting the effects of excess
cortisol in Cushing's syndrome patients. In April 2012, Corcept made
Korlym available as a once-daily oral treatment of hyperglycemia
secondary to endogenous Cushing's syndrome in adult patients with
glucose intolerance or diabetes mellitus type 2 who have failed
surgery or are not candidates for surgery. Korlym was the first
FDA-approved treatment for that illness and the FDA has designated it
as an Orphan Drug for that indication. Orphan Drug designation is a
special status designed to encourage the development of medicines for
rare diseases and conditions. Because Korlym is an Orphan Drug,
Corcept will have marketing exclusivity for the approved indication
in the United States until February 2019.
About Psychotic Depression
Psychotic depression is a serious psychiatric disorder that affects
approximately three million people annually in the United States. It
is more prevalent than either schizophrenia or bipolar I disorder.
Psychotic depression is characterized by severe depression
accompanied by delusions, hallucinations or both. People with the
disorder are approximately 70 times more likely to commit suicide
than the general population and often require lengthy and expensive
hospital stays. There is no FDA-approved treatment for psychotic
About Triple-Negative Breast Cancer
Triple-negative breast cancer is a form of the disease in which the
three receptors that fuel most breast cancer growth - estrogen,
progesterone, and the HER-2/neu gene - are not present. Since the
tumor cells lack the necessary receptors, common treatments, such as
hormone therapy and drugs that target estrogen, progesterone, and
HER-2, are ineffective. In 2013, approximately 40,000 women were
diagnosed with triple-negative breast cancer. There is no
FDA-approved treatment and neither a targeted treatment nor a
preferred standard chemotherapy regimen for relapsed triple-negative
breast cancer patients exists.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery,
development and commercialization of drugs for the treatment of
severe metabolic, psychiatric and oncologic disorders. Korlym, a
first generation GR antagonist, is the company's first FDA-approved
medication. The company has a phase 3 trial underway for mifepristone
for treatment of the psychotic features of psychotic depression, a
phase 1 trial of mifepristone for the treatment of triple-negative
breast cancer, and a portfolio of selective GR antagonists that block
the effects of cortisol but not progesterone. It owns extensive
intellectual property covering the use of GR antagonists, including
mifepristone, in the treatment of a wide variety of metabolic,
psychiatric and oncologic disorders. It also holds composition of
matter patents for its selective GR antagonists.
Statements made in this news release, other than statements of
historical fact, are forward-looking statements, including statements
relating to Corcept's estimated net revenue for the quarter and year
ended December 31, 2013, estimated cash balance as of December 31,
2013, anticipated net revenue for 2014 and the company's 2014
objectives. Forward-looking statements are subject to a number of
known and unknown risks and uncertainties that might cause actual
results to differ materially from those expressed or implied by such
statements, including completion of Corcept's financial closing
procedures, final adjustments and other developments that may arise
between now and the time the financial results for Corcept's fourth
quarter and full year 2013 are finalized. There can be no assurances
regarding the magnitude or timing of Corcept's revenues, the pace of
Korlym's acceptance by physicians and patients, the reimbursement
decisions of government or private insurers, the pace of enrollment
in or the outcome of the company's study of mifepristone in the
treatment of triple-negative breast cancer, the results of the
analysis of interim results of the company's Phase 3 trial of
mifepristone for the treatment of psychotic depression, the effects
of rapid technological change and competition, the protections
afforded by Korlym's Orphan Drug Designation or by Corcept's other
intellectual property rights, or the cost, pace and success of
Corcept's product development efforts. These and other risks are set
forth in the company's SEC filings, all of which are available from
the company's website (http://www.corcept.com) or from the SEC's
website (http://www.sec.gov). Corcept disclaims any intention or duty
to update any forward-looking statement made in this news release.
Chief Financial Officer
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