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Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
CORCEPT THERAPEUTICS
ANNOUNCES FOURTH QUARTER 2004 RESULTS
MENLO PARK, Calif.,
(March 3, 2005) -- Corcept Therapeutics Incorporated (NASDAQ: CORT) today
reported financial results for the fourth quarter and the full year 2004.
For the fourth quarter of 2004, Corcept reported a net loss of $5.3 million,
or $0.24 per share, compared to a net loss of $2.0 million, or $0.23 per
share for the fourth quarter of 2003. For the full year 2004, the company
reported a net loss of $15.5 million, or $0.84 per share. This compares
to a net loss of $9.8 million, or $1.22 per share, for the full year 2003.
As of December 31, 2004, Corcept had cash, cash equivalents and marketable
securities of $46.9 million. The total cash used in the company's operating
activities for the fourth quarter and full year 2004 was $4.9 million
and $13.7 million, respectively.
Total operating expenses
were $5.5 million for the fourth quarter of 2004, which included $4.3
million of research and development expenses. This compares to total operating
expenses of $2.0 million for the fourth quarter of 2003, which included
$1.2 million of research and development expenses. This increase in research
and development expenses over the prior year period was primarily related
to increased activity in the clinical development of CORLUX® for the
treatment of the psychotic features of psychotic major depression, or
PMD. General and administrative expenses increased to $1.2 million in
the fourth quarter of 2004 from $0.8 million for the same period in 2003,
attributable to increases in staffing, professional fees, insurance costs
and non-cash stock-based compensation.
"2004 has been
a year of accomplishments for Corcept," said Joseph K. Belanoff,
M.D., Corcept's Chief Executive Officer.
2004 highlights:
PMD Program
- We reached agreement
with the U.S. Food and Drug Administration (FDA) on Special Protocol
Assessments (SPAs) for the design of two Phase III clinical trials evaluating
CORLUX for the treatment of the psychotic features of PMD. These trials
will be conducted at approximately 50 sites in the United States. Because
of the serious nature of PMD and the lack of approved drugs for the
disorder, the FDA previously granted Fast Track designation for CORLUX
for the treatment of the psychotic features of PMD.
- The Phase III studies
in the United States began enrollment in the second half of the year.
We anticipate reporting initial results from both of these trials in
the first half of 2006.
- We have selected
investigational sites and will soon begin enrollment for a third Phase
III trial in PMD in Europe. We expect to report the results of this
trial in late 2006.
Discovery Research
/ Intellectual Property
- We have identified
and filed patent applications for three series of selective GR-II antagonists,
compounds that, unlike CORLUX, do not block the progesterone receptor
and only block the GR-II receptor. We are currently evaluating which
compound or compounds we intend to move toward an Investigational New
Drug application (IND). We hope to initiate a human clinical trial with
the selected compound in 2006.
- We announced the
resolution of an issue relating to the inventorship of a patent exclusively
licensed by Corcept from Stanford University. The patent in question
covers the use of GR-II antagonists to treat the psychotic features
of PMD. Under the resolution, Corcept will retain its exclusive rights
to the patent with no change in the previously agreed to royalty payment
schedule.
Alzheimer's Disease
Program
- Enrollment continues
in our Phase II clinical trial. We hope to report results by the end
of 2005.
Dr. Belanoff added,
"We believe that our $46.9 million in cash and marketable securities
will enable us to complete the clinical development, as currently planned,
of CORLUX, our lead product candidate for the treatment of the psychotic
features of PMD."
Commenting on Corcept's
financial guidance for 2005, Fred Kurland, Corcept's Chief Financial Officer,
stated, "Because we will have three Phase III clinical trials under
way, we anticipate an increase in spending in 2005 compared with 2004.
We currently expect the net cash used to be between $25 million and $30
million for 2005. Additionally, we expect that the 2005 net loss per share
will range from $1.15 to $1.38, excluding the impact of Financial Accounting
Standard 123(R), Share-Based Payments, which we plan to adopt in the third
quarter of 2005."
About Psychotic
Major Depression
PMD is a serious psychiatric disorder that affects approximately three
million people annually in the United States. It is more prevalent than
either schizophrenia or manic depressive illness. The disorder is characterized
by severe depression accompanied by delusions, hallucinations or both.
People with PMD 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 PMD.
About Corcept Therapeutics
Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged
in the development of drugs for the treatment of severe psychiatric and
neurological diseases. Corcept's lead product, CORLUX, is currently in
Phase III clinical trials for the treatment of the psychotic features
of psychotic major depression. The drug is administered orally to PMD
patients once per day for seven days. CORLUX, a potent GR-II antagonist,
appears to mitigate the effects of the elevated and abnormal release patterns
of cortisol seen in PMD. Corcept is also conducting a clinical trial to
evaluate the safety and efficacy of our product in improving cognition
in patients with mild to moderate Alzheimer's disease. For additional
information about the company, please visit www.corcept.com.
Statements made in this news release, other than statements of historical
fact, are forward-looking statements, including, for example, statements
relating to our PMD clinical development program, the expected timing
of results of our clinical trials, our spending pace, and our expected
financial results. 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.
For example, there can be no assurances with respect to the commencement,
cost, rate of spending, completion or success of clinical trials; there
can be no assurances with respect to the regulatory process or regulatory
approvals; there can be no assurances with respect to commercial success;
and financial projections may not be accurate. These and other risk factors
are set forth in the Company's SEC filings, all of which are available
from our website (www.corcept.com) or from the SEC's website (www.sec.gov).
We disclaim any intention or duty to update any forward-looking statement
made in this news release.
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CORCEPT
THERAPEUTICS INCORPORATED
CONDENSED BALANCE SHEETS
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December 31,
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December 31,
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2004
(Unaudited)
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2003
(Note)
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ASSETS:
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Current assets:
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Cash,
cash equivalents and short-term investments
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$
37,401,133
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$ 11,577,283
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Other
current assets
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838,114
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165,341
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Total current assets
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38,239,247
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11,742,624
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Long-term
investments
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9,485,523
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-
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Other
assets
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46,858
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38,336
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Total
assets
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$ 47,771,628
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$ 11,780,960
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LIABILITIES AND STOCKHOLDER’S EQUITY:
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Current
liabilities:
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Accounts
payable
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$
549,516
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$ 321,806
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Other
current liabilities
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1,274,525
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692,180
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Total
current liabilities
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1,824,041
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1,013,986
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Other
liabilities
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-
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523,689
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Total
liabilities
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1,824,041
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1,537,675
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Convertible
preferred stock
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-
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41,715,974
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Total
stockholders’ equity (deficit)
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45,947,587
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(31,472,689)
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Total
liabilities and stockholders’ equity
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$
47,771,628
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$ 11,780,960
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CORCEPT
THERAPEUTICS INCORPORATED
STATEMENT OF OPERATIONS
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For the Three Months Ended
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For the Year
Ended
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December 31, _
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December 31, _
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2004
(Unaudited)
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2003
(Unaudited)
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2004
(Unaudited)
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2003
(Note)
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OPERATING EXPENSES:
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Research
and development*
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$ 4,306,513
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$ 1,181,710
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$
11,550,771
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$ 8,223,014
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General
and administrative*
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1,215,881
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836,652
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4,494,064
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1,746,278
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5,522,394
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2,018,362
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16,044,835
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9,969,292
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Interest
and other income, net
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232,678
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34,048
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578,238
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190,765
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Non-operating
expense
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(21,330)
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(5,208)
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(67,884)
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(33,835)
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Net
loss
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$ (5,311,046)
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$ (1,989,522)
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$
(15,534,481)
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$
(9,812,362)
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Basic and diluted net
loss per share
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$ (0.24)
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$ (0.23)
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$
(0.84)
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$
(1.22)
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Shares used in computing
basic and diluted net loss per share
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22,556,092
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8,496,224
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18,440,390
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8,068,560
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*Includes
non-cash stock-based compensation of the following:
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Research
and development
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$ 84,773
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$ 135,060
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$
202,434
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$ 551,176
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General
and administrative
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289,664
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228,312
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1,474,949
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(307,772)
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Total non-cash
stock-based compensation
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$ 374,437
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$ 363,372
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$
1,677,383
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$ 243,404
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