Corcept Therapeutics Announces Fourth Quarter and Full Year Revenue and Corporate Update
February 12 2013 - 4:05PM
Marketwired
Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical
company engaged in the discovery, development and commercialization
of drugs for the treatment of severe metabolic and psychiatric
disorders, today reported its unaudited net revenue for the quarter
and the year ended December 31, 2012 and cash balance as of
December 31.
Corcept reported estimated net revenue of $1.4 million for the
fourth quarter of 2012 and $3.3 million for the full year. The
company's estimated cash and cash equivalents were $93.0 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.
In April 2012, Corcept began offering its first product, Korlymâ„¢
(mifepristone) 300 mg Tablets, as a once-daily oral treatment of
hyperglycemia secondary to endogenous Cushing's syndrome in adult
patients who have type 2 diabetes mellitus or glucose intolerance
and have failed surgery or are not candidates for surgery.
"This has been a pivotal year for Corcept," said Joseph K.
Belanoff, M.D., the company's Chief Executive Officer. "Following
the FDA's approval of Korlym, we have made great strides in
building the capabilities necessary to bring this effective
medicine to patients, including hiring medical science liaisons and
sales representatives, and working with insurers, charitable
organizations and our specialty pharmacy to make sure that every
patient has access to the medicine. We are pleased that a diverse
group of doctors has prescribed Korlym and that their patients are
responding so well."
2012 Corporate Highlights and 2013
Objectives
In 2012, Corcept:
- Received FDA approval of Korlym for the treatment of endogenous
Cushing's syndrome on the February 17th PDUFA date.
- Made Korlym commercially available to patients less than two
months after the drug's approval.
- Developed the infrastructure to promote Korlym, including
logistical capabilities, payer relations, hiring of medical science
liaisons and sales representatives, patient outreach and support,
and the hiring of other medical affairs, marketing and
administrative personnel.
- Raised $89.3 million, including $13.3 million from the exchange
and exercise of warrants, $46.1 million from the sale of common
stock and $29.9 million from a non-dilutive, capped royalty
financing.
- Increased the number of clinical trial sites in our phase 3
trial of mifepristone for treatment of psychotic depression.
- Expanded discovery and pre-clinical work on our proprietary
families of next-generation selective GR-II antagonists.
"We focused in 2012 on gaining regulatory approval and building
the commercial infrastructure needed to launch Korlym," said Dr.
Belanoff. "In 2013, successful commercialization of Korlym will
remain a key objective while we pursue our other strategic goals,
including enrolling a sufficient number of patients in our phase 3
study of mifepristone for the treatment of psychotic depression to
perform a successful interim analysis, and advancing more of our
next generation selective GR-II antagonists towards human use."
Conference Call
Corcept will hold a conference call on February 12, at 5:00 p.m.
Eastern Time (2:00 p.m. Pacific Time) to discuss this announcement.
To participate in the call, dial 1-866-813-5647 from the United
States or 1-847-619-6249 internationally. The pass code is
34250159. Please dial in approximately ten minutes before the start
of the call.
A replay of the call will be available through February 26, 2013
at 1-888-843-7419 from the United States and 1-630-652-3042
internationally. The pass code is 34250159.
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 to 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 Korlymâ„¢
Korlym blocks the glucocorticoid receptor type II (GR-II) to
which cortisol normally binds, thereby inhibiting the effects of
excess cortisol in Cushing's syndrome patients. On April 10, 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. The disorder is characterized by severe depression
accompanied by delusions, hallucinations or both. People with
psychotic depression 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 Corcept Therapeutics
Incorporated
Corcept is a pharmaceutical company engaged in the discovery,
development and commercialization of drugs for the treatment of
severe metabolic and psychiatric disorders. Korlym, a first
generation GR-II 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 and a portfolio of selective GR-II antagonists that
block the effects of cortisol but not progesterone. It owns
extensive intellectual property covering the use of GR-II
antagonists, including mifepristone, in the treatment of a wide
variety of metabolic and psychiatric disorders. It also holds
composition of matter patents for its selective GR-II
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, 2012, estimated cash balance as
of December 31, 2012, and the company's 2013 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 2012 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 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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