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Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
CORCEPT THERAPEUTICS
ANNOUNCES SECOND QUARTER 2004 RESULTS
MENLO PARK, Calif.,
(August 9, 2004) -- Corcept Therapeutics Incorporated (NASDAQ: CORT) today
reported financial results for the second quarter and six months ended
June 30, 2004.
For the second quarter of 2004, Corcept reported a net loss of $3.6 million,
or $0.18 per share compared to a net loss of $2.9 million, or $0.37 per
share for the second quarter of 2003. For the first six months of 2004,
the company reported a net loss of $6.1 million, or $0.43 per share. This
compares to a net loss of $5.7 million of $0.73 per share for the first
six months of 2003.
As of June 30, 2004, Corcept had cash, cash equivalents and marketable
securities of $55.2 million. The total cash used in the company's operating
activities for the second quarter and first six months of 2004 was $3.2
million and $5.4 million, respectively. In April 2004, Corcept completed
its initial public offering, in which the company sold 4,500,000 shares
of common stock at $12 per share. The net proceeds of this offering were
$49.0 million.
Total operating expenses
were $3.7 million for the second quarter of 2004 compared to total operating
expenses of $2.9 million in the second quarter of 2003. In the second
quarter of 2004, research and development expenses increased to $2.6 million
from $2.3 million in the second quarter of 2003. This increase was primarily
related to preparations for the commencement of pivotal clinical trials
for the treatment of the psychotic features of psychotic major depression
or PMD using CORLUX. These trials are expected to commence during the
second half of 2004. General and administrative expenses increased to
$1.1 million in the second quarter of 2004 from $615,000 for the same
period in 2003. This increase was attributable to an increase in non-cash
stock-based compensation, and increases in patent, legal and professional
fees, staffing costs and insurance costs.
Total operating expenses
were $6.3 million for the six months ended June 30, 2004, compared to
total operating expenses of $5.8 million in the first six months of 2003
"We believe that
the funds raised in our initial public offering will enable us to complete
the clinical development of our lead product candidate, CORLUX,
for the treatment of PMD," said Dr. Joseph Belanoff, Corcept's Chief
Executive Officer. "Due to the serious nature of PMD and the lack
of approved drugs for the disorder, the FDA has granted a Fast Track designation
for CORLUX for the treatment of the psychotic features of PMD. We made
good progress in the second quarter of 2004 preparing for the commencement
of pivotal Phase III trials. The goal of our pivotal trials is to demonstrate
that CORLUX causes a rapid and sustained reduction in the psychotic symptoms
of PMD, a result that we observed in the double-blind clinical study we
completed last December. We are in active dialogue with the FDA concerning
the design of these trials."
Commenting on Corcept's
financial guidance for the remainder of 2004, Fred Kurland, Corcept's
Chief Financial Officer, stated, "Our forecast for cash use for the
remainder of 2004 is unchanged from our view a quarter ago. After we commence
our pivotal clinical trials, we anticipate an increase in the pace of
spending over that experienced in the first half of 2004. We continue
to expect a net cash burn of between $15 million and $20 million for 2004."
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 sufficiency of our
cash, and our expected expenses. Forward-looking statements are subject
to a number of known and unknown risks and uncertainties which 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, 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. 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 CONSOLIDATED BALANCE SHEETS
(Unaudited)
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June 30,
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December 31,
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2004
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2003
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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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$52,033,627
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$11,577,283
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Other
current assets
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878,689
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165,341
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|
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Total current assets
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52,912,316
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11,742,624
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Long-term
investments
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3,160,107
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-
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Other
assets
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51,856
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38,336
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Total
assets
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$56,124,279
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$11,780,960
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LIABILITIES
AND STOCKHOLDER’S EQUITY:
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Current liabilities:
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Accounts payable
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$ 629,765
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$
321,806
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Other current liabilities
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770,799
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692,180
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Total current liabilities
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1,400,564
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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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1,400,564
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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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Stockholders’ equity:
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Common stock
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22,687
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9,335
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Additional paid-in capital
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101,549,861
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8,981,827
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Notes receivable from stockholders
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(246,258)
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(246,258)
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Deferred compensation
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(2,496,955)
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(2,279,524)
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Deficit accumulated during the development stage
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(44,072,096)
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(37,937,426)
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Accumulated other comprehensive loss
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(33,524)
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(643)
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Total stockholders’ equity
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54,723,715
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(31,472,689)
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Total liabilities and stockholders’ equity
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$56,124,279
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$11,780,960
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CORCEPT THERAPEUTICS INCORPORATED
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)
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For the Three Months Ended
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For the Six Months Ended
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June
30,
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June
30,
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2004
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2003
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2004
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2003
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OPERATING
EXENSES:
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Research
and development*
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$
2,569,419
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$ 2,308,352
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$ 4,146,003
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$ 5,493,207
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General
and administrative*
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1,125,027
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614,625
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2,118,472
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295,715
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3,694,446
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2,922,977
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6,264,475
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5,788,922
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Interest
and other income, net
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115,913
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46,530
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140,221
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105,901
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Interest
expense
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(5,208)
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(5,208)
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(10,416)
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(10,416)
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Net loss
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$(3,583,741)
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$(2,881,655)
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$(6,134,670)
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$(5,693,437)
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Basic and diluted net
loss per share
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$
(0.18)
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$
(0.37)
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$
(0.43)
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$
(0.73)
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Shares used in computing
basic and diluted net loss per share
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19,777,534
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7,877,765
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14,291,397
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7,791,082
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*Includes non-cash stock-based compensation of the following:
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Research and development
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$ 117,140
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$ 138,400
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$ 258,142
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$ 289,041
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General and administrative
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439,992
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217,987
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830,482
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(726,500)
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Total non-cash stock-based compensation
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$ 557,132
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$ 356,387
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$ 1,088,624
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$
(437,459)
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