Commercial & Financial
Highlights
Corcept Therapeutics Incorporated (NASDAQ:CORT), a pharmaceutical
company engaged in the discovery, development and commercialization
of drugs that treat severe metabolic, oncologic and psychiatric
disorders by modulating the effects of cortisol, today reported its
financial results for the quarter ended June 30, 2017.
Corcept reported quarterly revenue of $35.6
million, compared to revenue of $19.7 million in the second quarter
of 2016, an increase of 80 percent.
The company raised its 2017 revenue guidance
from $125-135 million to $145-155 million.
Second quarter GAAP net income was $12.6
million, compared to GAAP net income of $1.0 million in the second
quarter of 2016. Excluding non-cash expenses related to
stock-based compensation and interest on the Royalty Financing,
Corcept generated $16.0 million of non-GAAP net income in the
second quarter, compared to non-GAAP net income of $3.2 million in
the second quarter of 2016. A reconciliation of GAAP to non-GAAP
net income is set forth below.
“Our excellent performance last quarter
demonstrates the fundamental strength of our Cushing’s syndrome
franchise,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive
Officer. “Increasing numbers of physicians recognize that
using Korlym® to modulate cortisol activity is the optimum
treatment for many patients. At the same time, our field
force is doing a superb job educating physicians about the value of
screening patients for hypercortisolism. This is especially
true in the community setting, where the vast majority of patients
receive their care.
“The efficacy of Korlym is what fuels our strong
growth,” added Dr. Belanoff. “Successful development of our
next-generation cortisol modulator, CORT125134, will augment that
growth. A medication with Korlym’s benefits but without the
side effects caused by Korlym’s affinity for the progesterone
receptor will make cortisol modulation a treatment option for even
more patients.”
“In the next few quarters, we will significantly
enlarge our cortisol modulation platform,” said Robert S. Fishman,
MD, Corcept’s Chief Medical Officer. “CORT118335, which shows
promise as a treatment for metabolic disorders such as fatty liver
disease and antipsychotic-induced weight gain, will enter Phase 1
this month. This quarter we will complete CLIA validation of
our FKBP5 gene activity assay, which we expect will allow
physicians to better diagnose and treat patients with
hypercortisolism. Our dose-ranging trial of CORT125281
combined with Xtandi will be studied in healthy subjects this
quarter and in patients with castration-resistant prostate cancer
next quarter. Later this year, we plan to open expansion
cohorts in our study of CORT125134 with Abraxane in patients with
solid-tumor cancers. Most important, our open-label trial of
CORT125134 as a treatment for Cushing’s syndrome continues to
accumulate patients. We expect final results in the first
quarter of 2018 and have begun planning our end-of-Phase 2 FDA
meeting and Phase 3 trial.”
Financial
Discussion
Operating expenses for the second quarter
increased to $22.8 million, from $18.2 million in the second
quarter of 2016, primarily due to increased spending on the
development of CORT125134, CORT118335, and CORT125281, and
increased compensation expense and pharmacy costs related to higher
revenue.
Corcept’s cash and marketable securities totaled
$67.7 million at June 30, 2017, compared to $57.3 million at March
31, 2017 and $41.8 million at June 30, 2016. These balances reflect
scheduled payments under the company’s royalty financing obligation
(the “Royalty Financing”) of $5.7 million in the second quarter of
2017 and $4.8 million in the first quarter of 2017.
Corcept extinguished its obligations under the
Royalty Financing in July 2017, making a final payment of $4.6
million.
Conference Call
Corcept will hold a conference call on August 1,
2017, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss
this announcement. To participate, dial 1-888-771-4371 from the
United States or 1-847-585-4405 internationally approximately 10
minutes before the start of the call. The passcode will be
45276605. A replay will be available through August 15, 2017 at
1-888-843-7419 from the United States and 1-630-652-3042
internationally. The passcode will be 45276605.
About
Hypercortisolism
Hypercortisolism, often referred to as Cushing’s
syndrome, is caused by excessive activity of the stress hormone
cortisol. Endogenous Cushing’s syndrome is an orphan
indication that most often affects adults aged 20-50. In the
United States, an estimated 20,000 patients have Cushing’s
syndrome, with about 3,000 new patients being diagnosed each
year. Symptoms vary, but most people experience 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 inhibits the effects of excess cortisol
in patients with hypercortisolism by modulating the activity at the
glucocorticoid receptor, one of the two receptors to which cortisol
binds. Korlym was the first FDA-approved treatment for
patients with Cushing’s syndrome and the FDA has designated it as
an Orphan Drug for that indication.
About Corcept
Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in
the discovery, development and commercialization of drugs that
treat severe metabolic, oncologic and psychiatric disorders by
modulating the effects of cortisol. Korlym® is the company’s first
FDA-approved medication. Corcept has a large portfolio of
proprietary compounds that modulate the effects of cortisol but not
progesterone. Corcept owns extensive intellectual property covering
the use of cortisol modulators, including mifepristone, in the
treatment of a wide variety of serious disorders, including
Cushing’s syndrome. It also holds composition of matter patents
covering its selective cortisol modulators.
Non-GAAP Measures of
Net Income
To supplement Corcept’s financial results
presented on a GAAP basis, we use non-GAAP measures of net income
that exclude non-cash stock-based compensation expense and the
interest expense of the Royalty Financing. We believe that these
non-GAAP measures help 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 income we
use may be different from, and not directly comparable to,
similarly titled measures used by other companies.
Forward-Looking
Statements
Statements and management quotations in this
press release, other than statements of historical fact, are
forward-looking statements. These are based on our current
plans and expectations and 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. Forward-looking statements include those
concerning our revenue guidance, the pace of Korlym’s acceptance by
physicians and patients, the timing and outcome of clinical trials
and regulatory meetings, the protections afforded by Korlym’s
Orphan Drug designation for Cushing’s syndrome and our other
intellectual property rights, including the composition of matter
patents covering our selective cortisol modulators and patents
concerning the use of cortisol modulators to treat patients with
Cushing’s syndrome, triple-negative breast cancer,
castration-resistant prostate cancer and other indications.
These and other risks are set forth in our SEC filings, which are
available at our website or from the SEC’s website. We disclaim any
intention or duty to update forward-looking statements made in this
press release.
Abraxane® is a registered trademark of
Celgene Corporation.Xtandi® is a registered trademark of Astellas
Pharma Inc.
CORCEPT THERAPEUTICS INCORPORATED |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
(Unaudited) |
|
|
(Note) |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash and
investments |
|
$ |
67,659 |
|
|
$ |
51,536 |
|
Trade
receivables, net of allowances |
|
|
9,504 |
|
|
|
9,860 |
|
Inventory |
|
|
6,299 |
|
|
|
5,164 |
|
Other
assets |
|
|
3,075 |
|
|
|
2,193 |
|
Total
assets |
|
$ |
86,537 |
|
|
$ |
68,753 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,082 |
|
|
$ |
2,290 |
|
Long-term
obligation |
|
|
4,573 |
|
|
|
14,664 |
|
Other
liabilities |
|
|
13,737 |
|
|
|
10,420 |
|
Stockholder's equity |
|
|
66,145 |
|
|
|
41,379 |
|
Total
liabilities and stockholders’ equity |
|
$ |
86,537 |
|
|
$ |
68,753 |
|
|
|
|
|
|
|
|
|
|
Note: Derived from audited financial statements at that
date |
|
CORCEPT THERAPEUTICS
INCORPORATED |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(in thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales, net |
|
|
35,559 |
|
|
|
19,724 |
|
|
|
63,158 |
|
|
|
35,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
775 |
|
|
|
426 |
|
|
|
1,421 |
|
|
|
829 |
|
Research
and Development |
|
|
7,876 |
|
|
|
5,672 |
|
|
|
15,052 |
|
|
|
10,307 |
|
Selling,
general and administrative |
|
|
14,113 |
|
|
|
12,118 |
|
|
|
29,150 |
|
|
|
22,549 |
|
Total operating
expenses |
|
$ |
22,764 |
|
|
$ |
18,216 |
|
|
$ |
45,623 |
|
|
$ |
33,685 |
|
Income from
operations |
|
|
12,795 |
|
|
|
1,508 |
|
|
|
17,535 |
|
|
|
2,100 |
|
Interest and other
expense |
|
|
(98 |
) |
|
|
(531 |
) |
|
|
(323 |
) |
|
|
(1,142 |
) |
Income before income
taxes |
|
|
12,697 |
|
|
|
977 |
|
|
|
17,212 |
|
|
|
958 |
|
Provision for income
taxes |
|
|
(50 |
) |
|
|
— |
|
|
|
(177 |
) |
|
|
— |
|
Net
income |
|
$ |
12,647 |
|
|
$ |
977 |
|
|
$ |
17,035 |
|
|
$ |
958 |
|
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized
gain/(loss) on available-for-sale securities |
|
|
(5 |
) |
|
|
— |
|
|
|
(17 |
) |
|
|
— |
|
Total
comprehensive income |
|
$ |
12,642 |
|
|
$ |
977 |
|
|
$ |
17,018 |
|
|
$ |
958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net
income per common share |
|
$ |
0.11 |
|
|
$ |
0.01 |
|
|
$ |
0.15 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net
income per common share |
|
$ |
0.10 |
|
|
$ |
0.01 |
|
|
$ |
0.14 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income per share |
|
|
113,249 |
|
|
|
110,034 |
|
|
|
113,059 |
|
|
|
109,848 |
|
Shares used in
computing diluted net income per share |
|
|
123,011 |
|
|
|
115,329 |
|
|
|
122,171 |
|
|
|
114,448 |
|
CORCEPT THERAPEUTICS
INCORPORATED |
|
RECONCILIATION OF GAAP TO NON-GAAP Net Income
/ (Loss) |
|
(in thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income |
|
$ |
12,647 |
|
|
$ |
977 |
|
|
$ |
17,035 |
|
|
$ |
958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
850 |
|
|
|
272 |
|
|
|
1,503 |
|
|
|
558 |
|
Selling, general and administrative |
|
|
2,355 |
|
|
|
1,384 |
|
|
|
4,403 |
|
|
|
2,712 |
|
Total stock-based compensation |
|
|
3,205 |
|
|
|
1,656 |
|
|
|
5,906 |
|
|
|
3,270 |
|
Accretion
of interest expense related to long-term obligation |
|
|
149 |
|
|
|
523 |
|
|
|
419 |
|
|
|
1,107 |
|
Non-GAAP net income, as
adjusted for non-cash expenses |
|
$ |
16,001 |
|
|
$ |
3,156 |
|
|
$ |
23,360 |
|
|
$ |
5,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic net income
per share |
|
$ |
0.11 |
|
|
$ |
0.01 |
|
|
$ |
0.15 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP diluted net income
per share |
|
$ |
0.10 |
|
|
$ |
0.01 |
|
|
$ |
0.14 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net
income per share, as adjusted for non-cash expenses |
|
$ |
0.14 |
|
|
$ |
0.03 |
|
|
$ |
0.21 |
|
|
$ |
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP diluted net
income per share, as adjusted for non-cash expenses |
|
$ |
0.13 |
|
|
$ |
0.03 |
|
|
$ |
0.19 |
|
|
$ |
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income per share |
|
|
113,249 |
|
|
|
110,034 |
|
|
|
113,059 |
|
|
|
109,848 |
|
Shares used in
computing diluted net income per share |
|
|
123,011 |
|
|
|
115,329 |
|
|
|
122,171 |
|
|
|
114,448 |
|
CONTACT:
Charles Robb
Chief Financial Officer
Corcept Therapeutics
650-688-8783
crobb@corcept.com
www.corcept.com
Corcept Therapeutics (NASDAQ:CORT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Corcept Therapeutics (NASDAQ:CORT)
Historical Stock Chart
From Sep 2023 to Sep 2024