Corcept Therapeutics Announces First Quarter 2014 Financial Results
Interim Analysis of Data From Phase 3 Trial of Mifepristone for
the Treatment of Psychotic Depression Fails to Demonstrate Efficacy
With Statistical Significance
MENLO PARK, CA--(Marketwired - May 7, 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
quarter ended March 31, 2014. The company also reported that
it is discontinuing its Phase 3 psychotic depression study (Study
14) based on the recommendation of the study's data monitoring
committee that the study was unlikely to meet its primary endpoint
with statistical significance.
First Quarter Financial Results and Upward Revision to Revenue
Guidance
Corcept continues to commercialize Korlym® for the treatment of
Cushing's syndrome, a devastating disease that afflicts more than
20,000 patients in the United States. "Our Cushing's syndrome
business continues to progress," said Joseph K. Belanoff, M.D.,
Corcept's Chief Executive Officer. "Physicians have been
prescribing Korlym in increasing numbers, reflecting the fact that
this medicine helps patients in important ways. We are
increasing our 2014 revenue guidance from a range of $24-28 million
to $25-29 million."
For the first quarter of 2014, Corcept recognized $4.4 million
in net product revenue compared to $1.7 million for the same period
in 2013. Corcept reported a net loss of $13.9 million, or
$0.14 per share, for the first quarter of 2014, compared to a net
loss of $12.1 million, or $0.12 per share, for the same period in
2013. The first quarter of 2014 net loss included $3.3 million
in performance bonuses paid to employees for accomplishments during
2013. No bonuses were paid in 2013.
The net loss for the first quarter of 2014 and the corresponding
period in 2013 each included significant non-cash expenses of $2.4
million. After adjusting for these non-cash expenses, the
company's net loss on a non-GAAP basis was $11.5 million, or $0.11
per share, for the first quarter of 2014, compared to $9.7 million,
or $0.10 per share, for the same period in 2013. A
reconciliation from GAAP net loss to non-GAAP net loss is contained
in a table attached to this press release.
Selling, general and administrative expenses in the first
quarter of 2014 were $9.8 million, compared to $8.4 million in the
first quarter of 2013. Research and development expenses in
the first quarter of 2014 were $7.3 million, compared to $4.3
million for the comparable period in 2013, primarily due to the
increased enrollment in Study 14 and additional spending to develop
Corcept's next-generation selective GR-II antagonists.
Corcept's cash balance as of March 31, 2014 was $43.6 million,
compared to $54.9 million as of December 31, 2013.
Phase 3 Trial of Mifepristone for the Treatment of Psychotic
Depression (Study 14)
An interim analysis of data from the first 226 patients to
enroll in Study 14 showed that the study had failed to reach its
primary endpoint -- a rapid and sustained reduction in the
patients' psychotic symptoms -- with statistical
significance. The independent data monitoring committee
advised Corcept that continuing the study to its full enrollment of
450 patients would be unlikely to generate a statistically
significant result. Corcept has decided to discontinue Study
14 and redeploy resources to more promising programs, particularly
in oncology.
Clinical Pipeline Progress
"Although the interim results of our psychotic depression study
are disappointing, our own research and the research of academic
investigators has shown that glucocorticoid receptor antagonism has
therapeutic potential in many serious diseases," said Dr.
Belanoff. "Our study of mifepristone in the treatment of
triple-negative breast cancer should yield initial efficacy results
in the first half of 2015; and we will move two of our
next-generation compounds into the clinic this year. In
addition, many other clinical studies are underway at leading
academic institutions to test the effectiveness of mifepristone and
our newer compounds in various indications. We expect that
2014 will be a busy and productive year."
Conference Call
Corcept will hold a conference call on May 7, 2014, at 4:30 p.m.
Eastern Time (1:30 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
37151424.
A replay of the call will be available through May 21, 2014 at
1-888-843-7419 from the United States and 1-630-652-3042
internationally. The pass code is 37151424.
About Korlym®
Korlym competitively blocks the glucocorticoid receptor type II
(GR) 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 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 20-50. 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. 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 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. Because 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. There is no FDA-approved treatment and neither
a targeted treatment nor a preferred standard chemotherapy regimen
for relapsed triple-negative breast cancer patients exists.
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. Korlym,
a first generation competitive GR antagonist, is the company's
first FDA-approved medication. The company has a Phase 1 trial
of mifepristone for the treatment of triple-negative breast cancer
and a portfolio of selective GR antagonists that competitively
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, psychiatric and oncologic disorders. 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.
Forward-Looking Statements
Statements made in this news release, other than statements of
historical fact, are forward-looking statements. These
forward-looking statements, including statements regarding the
magnitude or timing of Corcept's revenues and expenses, are subject
to 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 reimbursement decisions of government
or private insurers, the pace of enrollment in or the outcome of
the company's study of mifepristone in the treatment of
triple-negative breast cancer, 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. 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) |
|
|
|
March 31, 2014 |
|
December 31, 2013 |
|
|
(Unaudited) |
|
(Note) |
|
|
|
|
|
|
|
ASSETS: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
43,618 |
|
$ |
54,877 |
|
Trade receivables, net |
|
|
1,922 |
|
|
1,428 |
|
Inventory |
|
|
5,457 |
|
|
5,546 |
|
Other assets |
|
|
1,834 |
|
|
1,226 |
|
|
Total
assets |
|
$ |
52,831 |
|
$ |
63,077 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,666 |
|
$ |
2,381 |
|
Deferred revenue |
|
|
29 |
|
|
25 |
|
Long-term obligation |
|
|
35,114 |
|
|
35,065 |
|
Other liabilities |
|
|
4,651 |
|
|
4,589 |
|
Stockholders' equity |
|
|
9,371 |
|
|
21,017 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
52,831 |
|
$ |
63,077 |
|
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 March 31, |
|
|
|
|
|
|
|
|
|
|
2014 |
|
|
2013 |
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
4,405 |
|
|
$ |
1,717 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
174 |
|
|
|
20 |
|
|
Research and development |
|
|
7,285 |
|
|
|
4,257 |
|
|
Selling, general and administrative |
|
|
9,805 |
|
|
|
8,383 |
|
|
|
Total
operating expenses |
|
|
17,264 |
|
|
|
12,660 |
|
Loss from operations |
|
|
(12,859 |
) |
|
|
(10,943 |
) |
|
|
|
|
|
|
|
|
|
Interest and other expense |
|
|
(1,071 |
) |
|
|
(1,141 |
) |
|
|
Net
loss |
|
$ |
(13,930 |
) |
|
$ |
(12,084 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.14 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per
share |
|
|
100,521 |
|
|
|
99,814 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS INCORPORATED |
|
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS |
|
(in thousands, except per share amounts) |
|
|
|
(Unaudited) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
2014 |
|
|
2013 |
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(13,930 |
) |
|
$ |
(12,084 |
) |
|
|
|
|
|
|
|
|
|
Significant non-cash expenses: |
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
162 |
|
|
|
148 |
|
|
|
Selling, general and administrative |
|
|
1,216 |
|
|
|
1,162 |
|
|
|
|
Total
stock-based compensation |
|
|
1,378 |
|
|
|
1,310 |
|
|
Accretion of interest expense related to long-term
obligation |
|
|
1,044 |
|
|
|
1,115 |
|
Non-GAAP net loss, as adjusted for significant non-cash
expenses |
|
$ |
(11,508 |
) |
|
$ |
(9,659 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic and diluted net loss per share |
|
$ |
(0.14 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
Non-GAAP basic and diluted net loss per share, as
adjusted for significant non-cash expenses |
|
$ |
(0.11 |
) |
|
$ |
(0.10 |
) |
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per
share |
|
|
100,521 |
|
|
|
99,814 |
|
CONTACT: Charles Robb Chief Financial Officer Corcept
Therapeutics 650-688-8783 Email Contact www.corcept.com
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