Corcept Therapeutics Announces Fourth Quarter and Full Year 2013
Financial Results
MENLO PARK, CA--(Marketwired - Mar 5, 2014) - Corcept
Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company
engaged in the discovery, development and commercialization of
drugs for the treatment of severe metabolic, psychiatric and
oncologic disorders, today reported its financial results for the
fourth quarter and full year ended December 31, 2013.
For the fourth quarter of 2013, Corcept recognized $4.1 million
in net product revenue compared to $1.4 million for the same period
in 2012, after deducting associated government rebates, chargebacks
and other allowances. For the full year 2013, Corcept reported net
product revenue of $10.4 million compared to $3.3 million in the
comparable period in 2012. Cost of sales for the fourth quarter of
2013 and the full year 2013 were $60,000 and $143,000,
respectively, compared to $19,000 and $91,000 for the comparable
periods in 2012. Cost of sales includes the cost to manufacture
Korlym (which includes material, third-party manufacturing costs
and indirect personnel and other overhead costs) based on units
sold in the current period, as well as the cost of stability
testing and distribution.
Corcept reported a net loss of $11.1 million, or $0.11 per
share, for the fourth quarter of 2013, compared to a net loss of
$11.1 million, or $0.11 per share for the same period in 2012. For
the fiscal year ended December 31, 2013, Corcept reported a net
loss of $46.0 million, or $0.46 per share, compared to a net loss
of $38.0 million, or $0.41 per share for the full year 2012.
The net loss for the fourth quarter of 2013 included significant
non-cash expenses of $2.4 million, compared to $2.2 million for the
fourth quarter of 2012. For the full year 2013, the net loss
included significant non-cash expenses of $9.6 million, as compared
to $7.0 million for the full year of 2012. After adjusting for
these non-cash expenses, the company's net loss on a non-GAAP basis
was $8.7 million, or $0.09 per share, for the fourth quarter of
2013, compared to $9.0 million, or $0.09 per share, for the same
period in 2012. For the fiscal year ended December 31, 2013, the
non-GAAP net loss was $36.4 million, or $0.36 per share, compared
to $31.1 million, or $0.33 per share, for the full year 2012. A
reconciliation from U.S. GAAP net loss to non-GAAP net loss is
included in this press release.
Corcept's cash balance as of December 31, 2013 was $54.9
million, as compared to $93.0 million at December 31, 2012. During
the year, we spent $37.1 million on operating activities and issued
payments of $1.0 million related to our capped royalty financing
obligation.
Operating expenses for the fourth quarter were $14.1 million,
compared to $11.4 million for the fourth quarter of 2012. Operating
expenses for the full year 2013 were $51.9 million, compared to
$39.6 million for the same period in 2012.
- Selling, general and administrative (SG&A) expenses in
the fourth quarter of 2013 were $7.5 million, compared to $6.5
million for the comparable period in 2012. SG&A expenses
were $31.2 million for the full year 2013, compared to $25.4
million for the same period in 2012. The increases in both the
fourth quarter and full year were primarily due to
increased staffing, expansion of our contracted sales force,
consultancy and other professional services costs related to
the commercialization of Korlym®.
- Research and development (R&D) expenses in the fourth
quarter of 2013 were $6.6 million, compared to $4.9 million
for the comparable period in 2012. R&D expenses were $20.5
million for the full year 2013, compared to $14.1 million for
the same period in 2012. The increase was primarily due to
accelerated patient enrollment in the third and fourth
quarters in our Phase 3 study of mifepristone for the
treatment of psychotic depression, which was only
partially offset by decreases in costs for the clinical trials
with Korlym for Cushing's syndrome, drug-drug interaction and
other NDA-supportive studies.
Significant non-cash expenses included stock-based compensation
of $1.3 million and $5.2 million for the fourth quarter and full
year of 2013, respectively, as compared to $1.0 million and $5.3
million, respectively for the comparable periods of 2012. The full
year 2012 stock-based compensation expense 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 fourth
quarter and full year of 2013 included $1.1 million and $4.4
million, respectively, attributable to accretion of interest
expense on Corcept's capped royalty financing obligation, which we
entered into in August 2012. We recorded $1.1 million and $1.7
million, respectively, of accretion of interest expense on our
capped royalty transaction for the fourth quarter and full year of
2012.
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 to 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 Triple-Negative Breast Cancer
Triple-negative breast cancer is a form of the disease in which
the three receptors that fuel most breast cancer growth --
estrogen, progesterone, and the HER-2/neu gene -- are not present.
Since the tumor cells lack the necessary receptors, common
treatments, such as hormone therapy and drugs that target estrogen,
progesterone, and HER-2, are ineffective. In 2013, approximately
40,000 women were diagnosed with triple-negative breast cancer in
the United States. There is no FDA approved treatment and no
accepted standard of care for these patients.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery,
development and commercialization of drugs for the treatment of
severe metabolic, psychiatric and oncologic disorders. The FDA has
approved the company's first drug, Korlym® (mifepristone) 300 mg
Tablets, a glucocorticoid receptor antagonist, as a once-daily oral
treatment for 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. The company also has a Phase 3 trial underway for
mifepristone for treatment of psychotic depression and a portfolio
of selective GR antagonists that block the effects of cortisol but
not progesterone. It owns extensive intellectual property covering
the use of GR antagonists, including mifepristone, in the treatment
of a wide variety of metabolic and psychiatric disorders and in
triple-negative breast cancer. It also holds composition of matter
patents for its selective GR 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) |
|
|
|
December 31, 2013 |
|
December 31, 2012 |
|
|
(Unaudited) |
|
(Note) |
|
|
|
|
|
|
|
ASSETS: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
54,877 |
|
$ |
93,032 |
|
Trade receivables, net |
|
|
1,428 |
|
|
557 |
|
Inventory |
|
|
5,546 |
|
|
4,663 |
|
Other assets |
|
|
1,226 |
|
|
914 |
|
|
Total
assets |
|
$ |
63,077 |
|
$ |
99,166 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,381 |
|
$ |
3,804 |
|
Deferred revenue |
|
|
25 |
|
|
16 |
|
Long-term obligation |
|
|
35,065 |
|
|
31,680 |
|
Other liabilities |
|
|
4,589 |
|
|
1,889 |
|
Stockholders' equity |
|
|
21,017 |
|
|
61,777 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
63,077 |
|
$ |
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 December 31, |
|
|
Year Ended December 31, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2013 |
|
|
2012 |
|
|
2013 |
|
|
2012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
4,115 |
|
|
$ |
1,377 |
|
|
$ |
10,357 |
|
|
$ |
3,307 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
60 |
|
|
|
19 |
|
|
|
143 |
|
|
|
91 |
|
|
Research and development |
|
|
6,567 |
|
|
|
4,856 |
|
|
|
20,470 |
|
|
|
14,074 |
|
|
Selling, general and administrative |
|
|
7,517 |
|
|
|
6,482 |
|
|
|
31,240 |
|
|
|
25,414 |
|
|
|
Total
operating expenses |
|
|
14,144 |
|
|
|
11,357 |
|
|
|
51,853 |
|
|
|
39,579 |
|
Loss from operations |
|
|
(10,029 |
) |
|
|
(9,980 |
) |
|
|
(41,496 |
) |
|
|
(36,272 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Interest and other expense |
|
|
(1,095 |
) |
|
|
(1,144 |
) |
|
|
(4,515 |
) |
|
|
(1,776 |
) |
|
|
Net
loss |
|
$ |
(11,124 |
) |
|
$ |
(11,124 |
) |
|
$ |
(46,011 |
) |
|
$ |
(38,048 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.11 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net
loss per share |
|
|
99,833 |
|
|
|
99,796 |
|
|
|
99,819 |
|
|
|
93,015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS INCORPORATED |
|
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS |
|
(in thousands, except per share amounts) |
|
|
|
(Unaudited) |
|
|
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2013 |
|
|
2012 |
|
|
2013 |
|
|
2012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(11,124 |
) |
|
$ |
(11,124 |
) |
|
$ |
(46,011 |
) |
|
$ |
(38,048 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Significant non-cash expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
153 |
|
|
|
130 |
|
|
|
618 |
|
|
|
546 |
|
|
|
Selling, general and administrative |
|
|
1,160 |
|
|
|
916 |
|
|
|
4,578 |
|
|
|
4,764 |
|
|
|
|
Total
stock-based compensation |
|
|
1,313 |
|
|
|
1,046 |
|
|
|
5,196 |
|
|
|
5,310 |
|
|
Accretion of interest expense related to long-term
obligation |
|
|
1,070 |
|
|
|
1,105 |
|
|
|
4,410 |
|
|
|
1,680 |
|
|
|
Non-GAAP net loss |
|
$ |
(8,741 |
) |
|
$ |
(8,973 |
) |
|
$ |
(36,405 |
) |
|
$ |
(31,058 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic and diluted net loss per share |
|
$ |
(0.11 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic and diluted net loss per share as
adjusted for significant non-cash expenses |
|
$ |
(0.09 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net
loss per share |
|
|
99,833 |
|
|
|
99,796 |
|
|
|
99,819 |
|
|
|
93,015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACT: Charles Robb Chief Financial Officer Corcept
Therapeutics 650-688-8783 Email Contact www.corcept.com
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