|

Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
CORCEPT
THERAPEUTICS ANNOUNCES FOURTH QUARTER 2005 RESULTS
MENLO PARK, Calif.,
(March 8, 2006) -- Corcept Therapeutics Incorporated (NASDAQ: CORT)
today reported financial results for the fourth quarter and the full year
ended December 31, 2005.
For the fourth quarter
of 2005, Corcept reported a net loss of $5.2 million, or $0.23 per share,
compared to a net loss of $5.3 million, or $0.24 per share, for the fourth
quarter of 2004. For the full year 2005, the company reported a net loss
of $20.1 million, or $0.89 per share. This compares to a net loss of $15.5
million, or $0.84 per share, for the full year 2004.
As of December 31,
2005, Corcept had cash, cash equivalents and marketable securities of
$29.6 million. The total cash used in the company's operating activities
for the fourth quarter and full year 2005 was $3.8 million and $17.2 million,
respectively.
Total operating expenses
were $5.5 million for the fourth quarter of 2005, unchanged from the same
period in 2004. In the fourth quarter of 2005, research and development
expenses increased to $4.5 million from $4.3 million in the fourth quarter
of 2004. 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 decreased to $1.0 million for the fourth quarter of 2005, from
$1.2 million for the same period in 2004, primarily due to decreases in
stock-based and cash compensation.
Highlights for 2005
and early 2006 include:
PMD program
- The Company's Phase
III studies continued enrollment during the year. We are updating our
guidance and anticipate reporting initial results from the Corcept 07
and Corcept 09 trials in the third quarter of 2006 and from the Corcept
06 trial in the fourth quarter of 2006. Our previous guidance was to
anticipate the reporting of these results in the first half of 2006
for Corcept 07 and in the second half of 2006 for Corcept 09 and 06.
Intellectual property
- In February 2006,
we announced that the European Patent Office (EPO) allowed the Company's
patent covering the use of GR-II antagonists to treat the psychotic
features of PMD. This allowance followed our 2005 rebuttal to an observation
filed with the EPO by Akzo Nobel in 2004 challenging the claims of our
patent application. This patent is exclusively licensed to the Company
by Stanford University.
- In November 2005,
a U.S. patent was issued to the company for the use of GR-II antagonists
for the prevention and treatment of stress disorders.
Prevention of antipsychotic
medication-induced weight gain
- In May 2005, we
announced results from two preclinical studies conducted in a rat model
of olanzapine-induced weight gain. These studies demonstrated that CORLUX
has the potential both to reduce the weight gain associated with olanzapine
and to prevent the weight gain associated with the initiation of treatment
with olanzapine.
- In October 2005,
we announced an agreement with Eli Lilly and Company (Lilly) in which
Lilly agreed to fund Corcept's proof-of-concept clinical study evaluating
the ability of CORLUX to mitigate weight gain associated with the use
of olanzapine in healthy male volunteers. We began enrolling subjects
in this study in February 2006. Results are expected to be announced
in the third quarter of 2006.
Alzheimer's disease
proof-of-concept trial
- We closed enrollment
in our Phase II clinical study to evaluate CORLUX in patients with mild-to-moderate
Alzheimer's disease. The study had enrolled 80 of the originally planned
160 patients. We expect to report the results of this trial later this
month.
Commenting on Corcept's
financial guidance for 2006, Fred Kurland, Corcept's Chief Financial Officer,
stated, "Based on the timeline of our clinical development program,
we expect that net cash used in 2006 will be between $20 million and $25
million."
Joseph K. Belanoff,
M.D., Corcept's Chief Executive Officer further stated, "We believe
that our cash and marketable securities will enable us to complete, as
currently planned, the clinical development of our lead product candidate,
CORLUX, for the treatment of the psychotic features of PMD."
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. The Company is also conducting a proof-of-concept
study evaluating the ability of CORLUX to mitigate weight gain associated
with the use of olanzapine. 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 clinical and preclinical development programs, 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 whether our issued
patents will be successfully challenged, there can be no assurances with
respect to commercial success; and financial projections may not be accurate;
there can be no assurances that the proof of concept study will be completed,
that the study will be successful, or that Corcept will decide to pursue
further activities with respect to weight gain associated with olanzapine
or other antipsychotic medications. 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.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED BALANCE SHEETS
(in thousands)
| |
December 31,
2005
|
December 31,
2004
|
| |
| |
(Unaudited)
|
(Note)
|
|
ASSETS:
|
|
|
|
Current assets:
|
|
|
|
Cash, cash equivalents and short-term investments
|
$
29,080
|
$
37,401
|
|
Other current assets
|
425
|
838
|
|
Total current assets
|
29,505
|
38,239
|
|
|
|
|
|
Long-term
investments
|
539
|
9,486
|
|
Other
assets
|
112
|
47
|
|
Total assets
|
$ 30,156
|
$ 47,772
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDER’S EQUITY:
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable
|
$
549
|
$
550
|
|
Other current liabilities
|
2,972
|
1,274
|
|
Total current liabilities
|
3,521
|
1,824
|
|
Capital
lease obligation, long-term portion
|
42
|
-
|
|
Total
liabilities:
|
3,563
|
1,824
|
| |
|
|
|
Total
stockholders’ equity
|
26,593
|
45,948
|
| |
|
|
|
Total liabilities and stockholders’ equity
|
$ 30,156
|
$ 47,772
|
Note: Derived from
audited consolidated financial statements at that date.
CORCEPT
THERAPEUTICS INCORPORATED
STATEMENT OF OPERATIONS
(in thousands, except per share amounts)
| |
For the Three
Months Ended
December
31,
|
Year Ended
December 31, |
| |
| |
2005
|
2004
|
2005
|
2004
|
| |
(Unaudited) |
(Unaudited) |
(Unaudited) |
(Audited) |
| OPERATING
EXPENSES: |
|
|
|
|
|
Research and
development*
|
$ 4,514
|
$ 4,307
|
$ 17,074
|
$ 11,551
|
|
General and
administrative*
|
991
|
1,216
|
4,084
|
4,494
|
|
Total operating expenses
|
5,505
|
5,523
|
21,158
|
16,045
|
|
Interest and
other income, net
|
275
|
233
|
1,117
|
578
|
|
Non-operating
expense
|
(17)
|
(21)
|
(52)
|
(68)
|
|
Net loss
|
$ (5,247)
|
$ (5,311)
|
$ (20,093)
|
$ (15,535)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share
|
$ (0.23)
|
$ (0.24)
|
$ (0.89)
|
$ (0.84)
|
|
Shares
used in computing basic and diluted net loss per share
|
22,640
|
22,556
|
22,608
|
18,440
|
|
|
|
|
|
|
|
*Includes non-cash
stock-based compensation of the following:
|
|
|
|
|
|
Research and
development
|
$
41
|
$ 84
|
$ (26)
|
$ 202
|
|
General and
administrative
|
153
|
290
|
799
|
1,475
|
|
Total non-cash
stock-based compensation
|
$ 194
|
$ 374
|
$ 773
|
$ 1,677
|
|
|
|
|
|
|
|
|
|