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 financial results for the quarter
ended March 31, 2013.
First Quarter Financial Results
For the first quarter of 2013, Corcept recognized $1.7 million
in net product revenue, after deducting associated government
rebates, chargebacks and other allowances. Cost of sales for the
first quarter of 2013 was $20,000. Because we expensed product
manufacturing costs incurred prior to FDA approval in February
2012, our cost of sales in the first quarter of 2013 consisted
primarily of stability testing and distribution costs.
Corcept reported a net loss of $12.1 million, or $0.12 per
share, for the first quarter of 2013, compared to a net loss of
$11.0 million, or $0.13 per share for the same period in 2012.
The net loss for the first quarter of 2013 and the corresponding
period in 2012 each included significant non-cash expenses of $2.4
million. After adjusting for these non-cash expenses, the company's
net loss on a non-GAAP basis was $9.7 million, or $0.10 per share,
for the first quarter of 2013, compared to $8.6 million, or $0.10
per share, for the same period in 2012. A reconciliation from GAAP
net loss to non-GAAP net loss is included in this press
release.
Corcept's cash balance as of March 31, 2013 was $81.5 million,
as compared to $93.0 million at December 31, 2012, and reflects
approximately $11.6 million spent on operations during the first
quarter of 2013.
Operating expenses for the first quarter were $12.7 million,
compared to $11.0 million for the first quarter of 2012.
- Selling, general and administrative expenses in the first
quarter of 2013 were $8.4 million, compared to $7.5 million for the
comparable period in 2012. The increase was primarily due to
increased staffing, consultancy and other professional services
costs related to the commercialization of Korlym®.
- Research and development expenses in the first quarter of 2013
were $4.3 million, compared to $3.5 million for the comparable
period in 2012. The increase was primarily due to the expansion of
our phase 3 trial of mifepristone for the treatment of psychotic
depression and the development of our next-generation selective
GR-II antagonists.
Significant non-cash expenses included stock-based compensation
of $1.3 million for the first quarter of 2013, as compared to $2.4
million for the comparable period of 2012. Stock-based compensation
expense for the first quarter of 2012 included $1.3 million related
to performance-based stock options that vested in their entirety on
the approval by the FDA of our New Drug Application for Korlym in
February 2012. In addition, the net loss for the first quarter of
2013 included $1.1 million attributable to accretion of interest
expense on Corcept's capped royalty financing transaction, which we
entered into in August 2012.
"We are pleased that the number of physicians prescribing Korlym
for the first time, as well as physicians issuing prescriptions for
their second, third and fourth patients, continues to grow," said
Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. "Our
goal remains to bring Korlym to every patient it can help."
In April 2012, Corcept began offering its first product, Korlym
(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.
Conference Call
Corcept will hold a conference call on May 2, 2013, at 5:00 p.m.
Eastern Time (2:00 p.m. Pacific Time) to discuss this announcement.
To participate, dial 1-888-771-4371 in the United States or
1-847-585-4405 internationally approximately ten minutes before the
start of the call. The pass code is 34774024.
A replay of the call will be available through May 16, 2013 at
1-888-843-7419 from the United States and 1-630-652-3042
internationally. The pass code is 34774024.
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 Korlym®
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.
Non-GAAP Measures of Net Loss
To supplement Corcept's financial results presented on a GAAP
basis, we use non-GAAP measures of net loss that exclude
significant non-cash expenses related to stock-based compensation
expense and the accretion of interest expense under our capped
royalty financing transaction. We believe that this non-GAAP
measure of net loss helps investors better evaluate the company's
past financial performance and potential future results. Non-GAAP
measures should not be considered in isolation or as a substitute
for comparable GAAP accounting and investors should read them in
conjunction with the company's financial statements prepared in
accordance with GAAP. The non-GAAP measure of net loss we use may
be different from, and not directly comparable to, similarly titled
measures used by other companies.
"Safe Harbor" Statement under the Private
Securities Litigation Reform Act of 1995
Statements made in this news release, other than statements of
historical fact, are forward-looking statements. 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 the
pace of Korlym's acceptance by physicians and patients, 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, including its ability to
advance its next-generation GR-II antagonists towards human use.
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.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED BALANCE SHEETS
(in thousands)
March 31, December 31,
2013 2012
------------- -------------
(Unaudited) (Note)
ASSETS:
Cash and cash equivalents $ 81,460 $ 93,032
Trade receivables, net 1,143 557
Inventory 4,676 4,663
Other assets 862 914
------------- -------------
Total assets $ 88,141 $ 99,166
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Accounts payable $ 2,263 $ 3,804
Deferred revenue 76 16
Long-term obligation 32,795 31,680
Other liabilities 2,004 1,889
Stockholders' equity 51,003 61,777
------------- -------------
Total liabilities and stockholders' equity $ 88,141 $ 99,166
============= =============
Note: Derived from audited financial statements at that date.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31,
----------------------------
2013 2012
------------- -------------
Revenues:
Product sales, net $ 1,717 $ --
Operating expenses:
Cost of sales 20 --
Research and development 4,257 3,542
Selling, general and administrative 8,383 7,487
------------- -------------
Total operating expenses 12,660 11,029
------------- -------------
Loss from operations (10,943) (11,029)
Interest and other expense (1,141) (5)
------------- -------------
Net loss $ (12,084) $ (11,034)
============= =============
Basic and diluted net loss per share $ (0.12) $ (0.13)
============= =============
Shares used in computing basic and diluted net
loss per share 99,814 84,420
============= =============
CORCEPT THERAPEUTICS INCORPORATED
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31,
----------------------------
2013 2012
------------- -------------
GAAP net loss $ (12,084) $ (11,034)
Significant non-cash expenses:
Stock-based compensation
Research and development 148 118
Selling, general and administrative 1,162 2,270
------------- -------------
Total stock-based compensation 1,310 2,388
------------- -------------
Accretion of interest expense related to
long-term obligation 1,115 ―
------------- -------------
Non-GAAP net loss, as adjusted for significant
non-cash expenses $ (9,659) $ (8,646)
============= =============
GAAP basic and diluted net loss per share $ (0.12) $ (0.13)
============= =============
Non-GAAP basic and diluted net loss per share,
as adjusted for significant non-cash expenses $ (0.10) $ (0.10)
============= =============
Shares used in computing basic and diluted net
loss per share 99,814 84,420
============= =============
CONTACT: Charles Robb Chief Financial Officer Corcept
Therapeutics 650-688-8783 Email Contact www.corcept.com
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