Corcept Therapeutics Announces Fourth Quarter, Full Year 2013
Revenue and Provides 2014 Outlook
MENLO PARK, CA--(Marketwired - Jan 30, 2014) - 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 million.
"Korlym® 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 clinic."
2014 Objectives
- 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."
Conference Call
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.
About Korlym®
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 depression.
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.
CONTACT: Charles Robb Chief Financial Officer Corcept
Therapeutics 650-688-8783 Email Contact www.corcept.com
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