Corcept Therapeutics Incorporated (NASDAQ:CORT), a company engaged
in the discovery, development and commercialization of drugs to
treat severe metabolic, oncologic and psychiatric disorders by
modulating the effects of the stress hormone cortisol, today
reported its financial results for the quarter ended September 30,
2017.
Financial Highlights
- Third quarter revenue of $42.8 million, an increase of 97
percent from third quarter 2016
- 2017 revenue guidance increased to $157 – 162 million
- GAAP net income of $0.11 per share, compared to $0.02 per share
in third quarter 2016
- Cash and investments increased $9.0 million, to $76.7
million
Corcept reported quarterly revenue of $42.8
million, compared to $21.7 million in the third quarter of
2016. The company raised its 2017 revenue guidance from $145
– 155 million to $157 – 162 million.
The company’s third quarter GAAP net income was
$13.8 million, compared to $2.6 million in the same period last
year. Excluding non-cash expenses related to stock-based
compensation, Corcept generated $17.4 million of non-GAAP net
income in the third quarter, compared to $4.9 million in the third
quarter of 2016. A reconciliation of GAAP to non-GAAP net income is
set forth below.
Operating expenses for the third quarter
increased to $29.1 million, from $18.7 million in the third quarter
of 2016, primarily due to increased compensation expense, pharmacy
costs related to higher revenue and increased spending on the
development of relacorilant (the newly-approved generic name for
CORT125134), CORT118335 and CORT125281.
Corcept’s cash and marketable securities
increased $9.0 million in the third quarter, to $76.7
million. This balance reflects the final payment of $4.6
million under the company’s royalty financing agreement, which is
now fully extinguished.
“Our Cushing’s syndrome franchise had another
excellent quarter,” said Joseph K. Belanoff, MD, Corcept’s Chief
Executive Officer. “More and more physicians recognize that
Cushing’s syndrome sometimes goes undiagnosed and are screening
more aggressively for the disease. There is also growing
awareness that, for many patients, cortisol modulation with Korlym
is the best medical treatment.
“We expect our strong growth to continue,” added
Dr. Belanoff. “Relacorilant promises to provide Korlym’s
benefits, but without the side effects caused by Korlym’s affinity
for the progesterone receptor – an important medical improvement.
We also achieved CLIA-validation for our FKBP5 assay, a direct
measure of cortisol activity. This biologic test has the
potential to help physicians better diagnose and optimally treat
patients with hypercortisolism.”
Clinical Highlights
- Results in Phase 2 trial of relacorilant (generic name for
selective cortisol modulator CORT125134) expected by end of first
quarter 2018; planning underway for end-of-Phase 2 FDA meeting,
Phase 3 trial
- Phase 1/2 trial of relacorilant plus Abraxane® to open efficacy
cohort in patients with pancreatic cancer by year-end
- Phase 1 trial of selective cortisol modulator CORT125281 in
healthy subjects initiated; dose-ranging in combination with
Xtandi® (enzalutamide) in patients with castration-resistant
prostate cancer to start this quarter
- Selective cortisol modulator CORT118335 now in Phase 1; results
expected in second quarter 2018
- CLIA validation achieved for FKBP5 gene expression assay for
diagnosing and optimally treating patients with Cushing’s
syndrome
“We continue to broaden and advance our cortisol
modulation platform,” said Robert S. Fishman, MD, Corcept’s Chief
Medical Officer. “Development of relacorilant is our top
priority, with planning underway for an end-of-Phase 2 FDA meeting
and the start of Phase 3 in the third quarter of next year.
“We have made exciting progress in other areas
as well. By year-end, we plan to begin a dose-ranging trial of
CORT125281 combined with Xtandi to treat patients with
castration-resistant prostate cancer and to begin testing the
combination of relacorilant and Abraxane in patients with
pancreatic cancer. One of our most promising selective
cortisol modulators, CORT118335, has entered Phase 1. This
compound is very potent in animal models of fatty liver disease and
both the prevention and reversal of weight gain caused by
antipsychotic medications such as Zyprexa® (olanzapine) – serious
disorders that affect millions of people and for which there are no
approved treatments. We expect to begin Phase 2 trials for
both indications in the third quarter of 2018.”
Conference Call
Corcept will hold a conference call November 2,
2017, at 5:00 pm Eastern Time (2:00 pm Pacific Time). To
participate, dial 1-888-771-4371 from the United States or
1-847-585-4405 internationally ten minutes before the start of the
call. The passcode is 45799161. A replay will be
available through November 16, 2017 at 1-888-843-7419 from the
United States and 1-630-652-3042 internationally. The passcode will
be 45799161.
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 disease
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 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 United States and foreign
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 risks and uncertainties
that might cause actual results to differ materially from those the
forward-looking statements express or imply. 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 and 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.Zyprexa® is a registered trademark of Eli Lilly and
Company.
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS
INCORPORATEDCONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash and
investments |
|
$ |
76,664 |
|
|
$ |
51,536 |
|
Trade
receivables, net of allowances |
|
|
11,872 |
|
|
|
9,860 |
|
Inventory |
|
|
5,508 |
|
|
|
5,164 |
|
Other
assets |
|
|
16,628 |
|
|
|
2,193 |
|
Total
assets |
|
$ |
110,672 |
|
|
$ |
68,753 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
6,226 |
|
|
$ |
2,290 |
|
Long-term
obligation |
|
|
— |
|
|
|
14,664 |
|
Other
liabilities |
|
|
18,144 |
|
|
|
10,420 |
|
Stockholder's equity |
|
|
86,302 |
|
|
|
41,379 |
|
Total
liabilities and stockholders’ equity |
|
$ |
110,672 |
|
|
$ |
68,753 |
|
|
|
CORCEPT THERAPEUTICS
INCORPORATEDCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales, net |
|
|
42,763 |
|
|
|
21,725 |
|
|
|
105,921 |
|
|
|
57,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
976 |
|
|
|
668 |
|
|
|
2,397 |
|
|
|
1,497 |
|
Research
and Development |
|
|
11,693 |
|
|
|
7,054 |
|
|
|
26,745 |
|
|
|
17,360 |
|
Selling,
general and administrative |
|
|
16,471 |
|
|
|
10,931 |
|
|
|
45,621 |
|
|
|
33,480 |
|
Total operating
expenses |
|
$ |
29,140 |
|
|
$ |
18,653 |
|
|
$ |
74,763 |
|
|
$ |
52,337 |
|
Income from
operations |
|
|
13,623 |
|
|
|
3,072 |
|
|
|
31,158 |
|
|
|
5,172 |
|
Interest and other
expense |
|
|
86 |
|
|
|
(487 |
) |
|
|
(237 |
) |
|
|
(1,629 |
) |
Income before income
taxes |
|
|
13,709 |
|
|
|
2,585 |
|
|
|
30,921 |
|
|
|
3,543 |
|
Income tax benefit
(expense) |
|
|
48 |
|
|
|
— |
|
|
|
(129 |
) |
|
|
— |
|
Net
income |
|
$ |
13,757 |
|
|
$ |
2,585 |
|
|
$ |
30,792 |
|
|
$ |
3,543 |
|
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain
(loss) on available-for-sale securities |
|
|
3 |
|
|
|
— |
|
|
|
(14 |
) |
|
|
— |
|
Total
comprehensive income |
|
$ |
13,760 |
|
|
$ |
2,585 |
|
|
$ |
30,778 |
|
|
$ |
3,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net
income per common share |
|
$ |
0.12 |
|
|
$ |
0.02 |
|
|
$ |
0.27 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net
income per common share |
|
$ |
0.11 |
|
|
$ |
0.02 |
|
|
$ |
0.25 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income per share |
|
|
113,603 |
|
|
|
110,652 |
|
|
|
113,242 |
|
|
|
110,118 |
|
Shares used in
computing diluted net income per share |
|
|
125,651 |
|
|
|
116,419 |
|
|
|
123,417 |
|
|
|
115,163 |
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS
INCORPORATEDRECONCILIATION OF GAAP TO NON-GAAP NET INCOME(in
thousands, except per share amounts) |
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income |
|
$ |
13,757 |
|
|
$ |
2,585 |
|
|
$ |
30,792 |
|
|
$ |
3,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
1,049 |
|
|
|
321 |
|
|
|
2,552 |
|
|
|
879 |
|
Selling,
general and administrative |
|
|
2,574 |
|
|
|
1,510 |
|
|
|
6,977 |
|
|
|
4,222 |
|
Total
stock-based compensation |
|
|
3,623 |
|
|
|
1,831 |
|
|
|
9,529 |
|
|
|
5,101 |
|
Accretion
of interest expense related to long-term obligation |
|
|
37 |
|
|
|
455 |
|
|
|
456 |
|
|
|
1,562 |
|
Non-GAAP net income, as
adjusted for non-cash expenses |
|
$ |
17,417 |
|
|
$ |
4,871 |
|
|
$ |
40,777 |
|
|
$ |
10,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic net income
per share |
|
$ |
0.12 |
|
|
$ |
0.02 |
|
|
$ |
0.27 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP diluted net income
per share |
|
$ |
0.11 |
|
|
$ |
0.02 |
|
|
$ |
0.25 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net
income per share, as adjusted for non-cash expenses |
|
$ |
0.15 |
|
|
$ |
0.04 |
|
|
$ |
0.36 |
|
|
$ |
0.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP diluted net
income per share, as adjusted for non-cash expenses |
|
$ |
0.14 |
|
|
$ |
0.04 |
|
|
$ |
0.33 |
|
|
$ |
0.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income per share |
|
|
113,603 |
|
|
|
110,652 |
|
|
|
113,242 |
|
|
|
110,118 |
|
Shares used in
computing diluted net income per share |
|
|
125,651 |
|
|
|
116,419 |
|
|
|
123,417 |
|
|
|
115,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACT:Charles RobbChief Financial OfficerCorcept
Therapeutics650-688-8783crobb@corcept.comwww.corcept.com
Corcept Therapeutics (NASDAQ:CORT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Corcept Therapeutics (NASDAQ:CORT)
Historical Stock Chart
From Apr 2023 to Apr 2024