Corcept Therapeutics Announces Third Quarter 2013 Financial Results
and Corporate Update
MENLO PARK, CA--(Marketwired - Nov 7, 2013) - 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 September 30, 2013.
Third Quarter Financial Results
- Recognized net revenue of $2.6 million, compared to $1.9
million in the previous quarter, an increase of 39 percent. Our
revenues would be about approximately 20 percent higher if patients
who are receiving Korlym but cannot pay for it could pay for it.
Our expectation is that, as the Affordable Care Act enables these
patients to obtain health insurance in 2014, they will become
paying customers.
- Recorded a GAAP net loss of $10.9 million, or $0.11 per share,
compared to a net loss of $11.9 million, or $0.12 per share in the
previous quarter. After adjusting for significant non-cash
expenses, net loss on a non-GAAP basis was $0.08 per share,
compared to $0.10 per share in the previous quarter. A
reconciliation of GAAP net loss to non-GAAP results is included in
this press release.
- As of September 30, 2013, we held cash and cash equivalents of
$63.2 million.
Operational Highlights
- Enrolled patients at a faster rate than projected in our phase
3 study of the use of mifepristone, the active ingredient in
Korlym®, in the treatment of psychotic depression. We now expect to
perform an interim analysis of data from this study and report its
results in the second quarter of 2014, one quarter earlier than
previously reported.
- Submitted our Marketing Authorization Application to the
European Medicines Agency (EMA) for approval to promote Korlym for
endogenous Cushing's syndrome in the European Union under the brand
name Corluxin®. We expect initial feedback and questions from the
EMA in the first quarter of 2014.
- Licensed from the University of Chicago patent rights covering
the use of competitive glucocorticoid (GR) antagonists, including
mifepristone, in combination with chemotherapy in the treatment of
triple-negative breast cancer, a form of breast cancer typically
with a poor prognosis. On December 12th, the University of Chicago
plans to report the findings from the first human study using
mifepristone to help treat metastatic triple-negative breast cancer
at the San Antonio Breast Cancer Symposium.
"We had an excellent third quarter, as evidenced by our nearly
40 percent increase in revenue," said Joseph K. Belanoff, M.D.,
Corcept's Chief Executive Officer. "Our Cushing's syndrome business
added new prescribers in every part of the country. Many physicians
with one patient taking Korlym found that the drug worked and wrote
prescriptions for second and third patients. With greater
visibility into the business, we can now provide revenue guidance
for the balance of 2013 and will provide revenue guidance for
fiscal 2014 at our year-end conference call."
"We also advanced our other strategic priorities," said Dr.
Belanoff. "Enrollment in our phase 3 trial for the treatment of
Psychotic Depression accelerated. We now expect to report results
of our interim analysis in the second quarter, earlier than
expected. In addition, investigators at the University of Chicago
will present findings from the first study of mifepristone combined
with chemotherapy to treat women with metastatic triple-negative
breast cancer at the Breast Cancer Symposium in San Antonio on
December 12th."
Financial Results
For the third quarter of 2013, we recognized net product revenue
of $2.6 million. Cost of sales for the third quarter of 2013 was
$40,000. Because we expensed product manufacturing costs incurred
prior to FDA approval, our cost of sales in the third quarter of
2013 consisted primarily of stability testing and distribution
costs.
We reported a net loss of $10.9 million, or $0.11 per share, for
the third quarter of 2013, compared to a net loss of $8.3 million,
or $0.08 per share, for the third quarter of 2012.
The net loss for the third quarter of 2013 and the third quarter
of 2012 included significant non-cash stock-based compensation
expenses of $1.3 million and $1.0 million, respectively. In
addition, we accreted non-cash interest expense related to our
capped royalty financing transaction of $1.1 million in the third
quarter of 2013 and $575,000 in the comparable period in 2012.
After adjusting for these non-cash expenses, the company's net loss
on a non-GAAP basis was $8.5 million, or $0.08 per share, for the
third quarter of 2013, compared to $6.7 million, or $0.07 per
share, for the third quarter of 2012. A reconciliation of GAAP net
loss to non-GAAP net loss is included below.
Operating expenses for the third quarter of 2013 were $12.4
million, compared to $8.7 million for the corresponding period in
2012.
- Selling, general and administrative expenses in the third
quarter of 2013 were $7.2 million, compared to $5.7 million
for the comparable period in 2012. The increase was primarily
due to increased staffing, consultancy, contracted sales force
and other professional services costs to support
the commercialization of Korlym.
- Research and development expenses in the third quarter of
2013 were $5.2 million, compared to $3.0 million for the
comparable period in 2012. The increase was primarily due to
increased clinical trials costs, staffing and consultancy to
support the expansion of our phase 3 trial of mifepristone for
the treatment of psychotic depression, the development of our
next-generation selective GR-II antagonists and the
preparation of the regulatory submission to the EMA for
approval of Corluxin for Cushing's syndrome in Europe.
Our cash balance as of September 30, 2013 was $63.2 million, as
compared to $93.0 million at December 31, 2012, and reflects
approximately $29.4 million spent on operations during the first
nine months of 2013.
Financial Guidance
Fulfilling our commitment to provide revenue guidance as soon as
clear trends in our business were established, we expect revenue
for 2013 to be approximately $9.6 million. We will provide revenue
guidance for fiscal year 2014 at our year-end conference call in
February 2014.
Conference Call
Corcept will hold a conference call on November 7, 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 35967600.
A replay of the call will be available through November 21, 2013
at 1-888-843-7419 from the United States and +1-630-652-3042
internationally. The pass code is 35967600.
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,
approximately half of whom are cured by surgery. Symptoms vary, but
most patients 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 competitively antagonizes the glucocorticoid receptor
type II (GR-II), one of the two receptors to which cortisol
normally binds, thereby inhibiting the effects of excess cortisol
in Cushing's syndrome patients. In April 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 competitive 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 competitively antagonize 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, psychiatric and other disorders. It
also holds composition of matter patents for its selective GR-II
antagonists.
Non-GAAP Measures
To supplement Corcept's financial results presented on a GAAP
basis, we use a non-GAAP measure of net loss that excludes
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 measures of net revenue and 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. Forward-looking
statements in this news release include but are not limited to
revenue guidance for 2013, quotes from management and statements
regarding increased revenue expectations as the Affordable Care Act
enables patients to obtain health insurance, the timing of an
interim analysis of data and reported results from our phase 3
trial of mifepristone for the treatment of psychotic depression,
the timing of feedback and questions from the EMA, and the timing
of reported findings from the University of Chicago regarding the
study in humans of mifepristone in combination with chemotherapy in
the treatment of metastatic triple-negative breast cancer. The
company's actual results may differ materially from those
anticipated in these forward-looking statements. Factors that may
contribute to such differences include, among others, 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
protections afforded by Korlym's Orphan Drug Designation, by
Corcept's patent portfolio, or by the company's other intellectual
property rights, the effects of rapid technological change and
competition, or the cost, pace and success of Corcept's product
development efforts, including its ability to advance its
next-generation selective 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,
except as may be required by law.
|
|
CORCEPT THERAPEUTICS INCORPORATED |
CONDENSED BALANCE SHEETS |
(in thousands) |
|
|
|
September 30, 2013 |
|
December 31, 2012 |
|
|
(Unaudited) |
|
(Note) |
|
|
|
|
|
|
|
ASSETS: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
63,175 |
|
$ |
93,032 |
|
Trade receivables, net |
|
|
1,019 |
|
|
557 |
|
Inventory |
|
|
5,555 |
|
|
4,663 |
|
Other assets |
|
|
1,308 |
|
|
914 |
|
|
Total
assets |
|
$ |
71,057 |
|
$ |
99,166 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,337 |
|
$ |
3,804 |
|
Deferred revenue |
|
|
55 |
|
|
16 |
|
Long-term obligation |
|
|
34,642 |
|
|
31,680 |
|
Other liabilities |
|
|
3,250 |
|
|
1,889 |
|
Stockholders' equity |
|
|
30,773 |
|
|
61,777 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
71,057 |
|
$ |
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
2013 |
|
|
2012 |
|
|
2013 |
|
|
2012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
2,634 |
|
|
$ |
1,055 |
|
|
$ |
6,242 |
|
|
$ |
1,930 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
40 |
|
|
|
24 |
|
|
|
82 |
|
|
|
72 |
|
|
Research and development |
|
|
5,155 |
|
|
|
3,008 |
|
|
|
13,903 |
|
|
|
9,218 |
|
|
Selling, general and administrative |
|
|
7,179 |
|
|
|
5,694 |
|
|
|
23,723 |
|
|
|
18,932 |
|
|
|
Total
operating expenses |
|
|
12,374 |
|
|
|
8,726 |
|
|
|
37,708 |
|
|
|
28,222 |
|
Loss from operations |
|
|
(9,740 |
) |
|
|
(7,671 |
) |
|
|
(31,466 |
) |
|
|
(26,292 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other expense |
|
|
(1,166 |
) |
|
|
(622 |
) |
|
|
(3,421 |
) |
|
|
(632 |
) |
|
|
Net
loss and comprehensive loss |
|
$ |
(10,906 |
) |
|
$ |
(8,293 |
) |
|
$ |
(34,887 |
) |
|
$ |
(26,924 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.11 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net
loss per share |
|
|
99,814 |
|
|
|
99,082 |
|
|
|
99,814 |
|
|
|
90,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS INCORPORATED |
|
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS |
|
(in thousands, except per share amounts) |
|
|
|
(Unaudited) |
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2013 |
|
|
2012 |
|
|
2013 |
|
|
2012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(10,906 |
) |
|
$ |
(8,293 |
) |
|
$ |
(34,887 |
) |
|
$ |
(26,924 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Significant non-cash expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
161 |
|
|
|
160 |
|
|
|
466 |
|
|
|
416 |
|
|
|
Selling, general and administrative |
|
|
1,148 |
|
|
|
833 |
|
|
|
3,417 |
|
|
|
3,848 |
|
|
|
|
Total
stock-based compensation |
|
|
1,309 |
|
|
|
993 |
|
|
|
3,883 |
|
|
|
4,264 |
|
|
Accretion of interest expense related to long-term
obligation |
|
|
1,133 |
|
|
|
575 |
|
|
|
3,340 |
|
|
|
575 |
|
Non-GAAP net loss |
|
$ |
(8,464 |
) |
|
$ |
(6,725 |
) |
|
$ |
(27,664 |
) |
|
$ |
(22,085 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic and diluted net loss per share |
|
$ |
(0.11 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic and diluted net loss per share as
adjusted for significant non-cash expenses |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net
loss per share |
|
|
99,814 |
|
|
|
99,082 |
|
|
|
99,814 |
|
|
|
90,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACT: Charles Robb Chief Financial Officer Corcept
Therapeutics 650-688-8783 Email Contact www.corcept.com
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