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 results for the quarter ended June 30, 2018.
Financial Highlights
- Revenue of $62.3 million, a 75 percent increase from second
quarter 2017
- GAAP net income of $0.14 per share, compared to $0.10 per share
in second quarter 2017
- Non-GAAP net income of $0.20 per share, compared to $0.13 per
share in second quarter 2017
- Cash and investments of $159.9 million, a $19.6 million
increase from first quarter 2018
- 2018 revenue guidance revised to $250 – 270 million, from $275
– 300 million
- Company announces $100 million stock repurchase program
Relacorilant Data
The final 18 patients enrolled in the trial (the
“High-Dose” cohort) receive 250 mg/day of relacorilant for four
weeks, with dose being increased, as tolerability permits, to 300
mg/day for four weeks, then 350 mg/day for four weeks, then 400
mg/day for four weeks; data are available for the 250 mg/day and
300 mg/day dose levels.
Based on FDA feedback, Corcept has developed
response criteria for relacorilant’s Phase 3 trial. Applying these
endpoints to the High-Dose cohort at eight weeks of treatment
(conclusion of the 300 mg dose level) produces the following
results:
- Fifty-eight percent of patients with hyperglycemia achieved
improved glucose control, as shown by a (i) 0.5 percent or greater
reduction in HbA1c or (ii) 50 mg/dl or greater reduction (or
normalization) in 2-hour glucose as measured in the oral glucose
tolerance test or (iii) 25 percent or greater decrease in
antidiabetic medications
- Fifty-five percent of patients with uncontrolled hypertension
achieved a five millimeter or greater drop in either systolic or
diastolic blood pressure, as measured by 24-hour ambulatory
monitoring
- No evidence of progesterone receptor affinity; no instances of
hypokalemia
- Testing of higher doses is ongoing; Phase 3 trial planned to
start this year
Oncologic and Metabolic
Disorders
- Placebo-controlled, Phase 2 trial of relacorilant plus
Abraxane® (nab-paclitaxel) in metastatic ovarian cancer planned to
start by year-end
- Results expected by year-end in study of relacorilant plus
Abraxane in patients with metastatic pancreatic cancer
- Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi®
(enzalutamide) in patients with metastatic castration-resistant
prostate cancer
- Planning underway for placebo-controlled, Phase 2 trials of
CORT118335 in patients with antipsychotic-induced weight gain and
non-alcoholic steatohepatitis (“NASH”); both trials planned to
start by year-end
Financial Results
Corcept reported quarterly revenue of $62.3
million, compared to $35.6 million in the second quarter of 2017.
Second quarter GAAP net income was $18.2 million, compared to $12.6
million in the same period last year. Excluding non-cash expenses
related to stock-based compensation, utilization of deferred tax
assets, accreted interest on the company’s retired royalty
financing obligation and related income tax effects, non-GAAP net
income in the second quarter was $25.4 million, compared to $16.0
million in the second quarter of 2017. (A reconciliation of GAAP to
non-GAAP net income is set forth below.) The company reduced its
2018 guidance to $250 – 270 million.
Second quarter operating expenses were $41.7
million, compared to $22.8 million in the second quarter of 2017,
primarily due to increased spending to advance relacorilant,
CORT118335 and CORT125281 and costs from increased sales
volume.
Cash and investments were $159.9 million at June
30, 2018, an increase of $19.6 million from first quarter 2018.
The company announced a program to repurchase up
to $100 million of its common stock, which it intends to fund using
cash and investments. Details of the program are provided
below.
“Our Cushing’s syndrome franchise continues its
significant growth, driven by physicians’ increasing realization
that hypercortisolism is a serious disorder and that cortisol
modulation is the best medical therapy for many patients,” said
Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “We are
confident this shift in medical practice will continue.”
Relacorilant’s Phase 2 Trial
“Interim data from our Phase 2 trial’s High-Dose
cohort showed that relacorilant provided clinically meaningful
benefit without the two off-target effects – progesterone receptor
affinity and increased cortisol levels – that cause Korlym®’s most
common and serious adverse events – termination of pregnancy,
endometrial thickening, vaginal bleeding and low potassium
(hypokalemia),” said Robert S. Fishman, MD, Corcept’s Chief Medical
Officer.
“That relacorilant did not cause hypokalemia in
these patients is surprising – and important,” he added.
“Forty-four percent of the patients in Korlym’s pivotal trial
experienced hypokalemia, which can be life-threatening. It is one
of the most common adverse events in patients taking Korlym
today.
“Interim efficacy data have also been
impressive. Based on our planned Phase 3 endpoints, 58 percent of
the patients with hyperglycemia achieved improved glucose control.
Applying the same endpoints, this figure was 48 percent at the
comparable time in Korlym’s pivotal trial (“SEISMIC”) and 23
percent at the conclusion of treatment in the Low-Dose cohort. (See
Figure 1) For patients with hypertension, 55 percent responded in
the High-Dose cohort, compared to 44 percent in SEISMIC and 45
percent of the Low-Dose cohort. (See Figure 2)
“Relacorilant was well-tolerated,” he concluded.
“We observed one serious adverse event, a pilonidal abscess, which
resolved without discontinuing relacorilant. One patient
discontinued due to musculoskeletal pain and fatigue – a relatively
common adverse event seen as cortisol modulation decreases cortisol
activity.”
Oncology
“At ASCO’s annual meeting this May, we reported
positive data from the dose-finding portion of our Phase 1/2 study
of relacorilant plus Abraxane to treat patients with solid tumors,”
added Dr. Fishman. “At the minimum therapeutic dose, four of nine
patients with metastatic pancreatic cancer and four of seven
patients with metastatic ovarian cancer demonstrated durable
disease control. These results are especially notable in patients
with such dire disease, all of whom had progressed on one or more
prior taxane-based treatments. Recently, another patient with
pancreatic cancer has achieved a partial response.
“These results justify significantly expanding
our oncology program. By year-end, we plan to open a
placebo-controlled, Phase 2 trial of relacorilant plus Abraxane in
metastatic ovarian cancer. We also expect to have enough data by
year-end in patients with metastatic pancreatic cancer to determine
if a definitive trial is warranted.”
Conference Call
Corcept will hold a conference call August 9,
2018, at 5:00 pm Eastern Time (2:00 pm Pacific Time). To
participate, dial 1-888-394-8218 from the United States or
1-323-794-2588 internationally ten minutes before the start of the
call (passcode: 6703650). A replay will be available through August
23, 2018 at 888-203-1112 from the United States and 719-457-0820
internationally (passcode: 6703650).
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 our first
FDA-approved medication. We have a large portfolio of proprietary
compounds that modulate the effects of cortisol but not
progesterone. We own 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. We also hold
composition of matter patents covering its selective cortisol
modulators.
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. Our first approved product,
Korlym, inhibits the effects of excess cortisol 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’s Stock Repurchase Program
Our Board of Directors has approved a program
authorizing the repurchase of up to $100 million of the company’s
common stock through June 30, 2019. Purchases under this program
may be made in the open market, in privately negotiated
transactions or otherwise. The timing and amount of any repurchases
will be determined based on market conditions, stock price and
other factors. The program does not require the company to
repurchase any specific number of shares of its common stock and
may be modified, suspended or discontinued at any time without
notice.
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 include the following non-cash items – stock-based
compensation, utilization of deferred tax assets to offset a
portion of our income tax liability, accreted interest on our
now-retired royalty financing obligation and related income tax
effects. We believe these non-GAAP measures help investors better
evaluate our 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 quotations in this press release,
other than statements of historical fact, are forward-looking
statements based on our plans and expectations and are subject to
risks and uncertainties that might cause actual results to differ
materially from those such statements express or imply. These risks
and uncertainties include, but are not limited to, our ability to
generate sufficient revenue to fund our commercial operations and
development programs, the protections afforded by Korlym’s Orphan
Drug designation and our intellectual property, the availability of
competing treatments, including generic versions of Korlym, our
ability to obtain acceptable prices or adequate insurance coverage
and reimbursement for Korlym, and scientific, regulatory,
management and financial risks related to the development of our
product candidates for any indication. These and other risks are
set forth in our SEC filings, available at our website and the
SEC’s website. In this press release, forward-looking statements
include those concerning our 2018 revenue guidance and expected
growth in 2019 and beyond; our stock repurchase program and its
intended funding sources; physician awareness of hypercortisolism
and selection of Korlym as the best medical therapy for many
patients and continued shift in medical practice; the clinical
attributes of relacorilant based on interim data; data from the
dose-finding portion of our Phase 1/2 study of relacorilant plus
Abraxane® as justification for significantly expanding our oncology
program; and the progress and results of our development programs,
including our current and planned clinical trials of relacorilant,
CORT125281 and CORT118335. 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, |
|
|
|
2018 |
|
|
2017(1) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash and
investments |
|
$ |
159,945 |
|
|
$ |
104,025 |
|
Trade
receivables, net of allowances |
|
|
28,704 |
|
|
|
15,300 |
|
Inventory |
|
|
10,447 |
|
|
|
8,376 |
|
Other
receivable |
|
|
— |
|
|
|
12,896 |
|
Deferred
tax assets |
|
|
71,102 |
|
|
|
76,703 |
|
Other
assets |
|
|
4,184 |
|
|
|
3,237 |
|
Total
assets |
|
$ |
274,382 |
|
|
$ |
220,537 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
6,365 |
|
|
$ |
8,579 |
|
Other
liabilities |
|
|
24,508 |
|
|
|
20,990 |
|
Stockholders’ equity |
|
|
243,509 |
|
|
|
190,968 |
|
Total
liabilities and stockholders’ equity |
|
$ |
274,382 |
|
|
$ |
220,537 |
|
|
|
|
|
|
|
|
|
|
(1)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 EndedJune 30, |
|
Six Months EndedJune
30, |
|
|
2018 |
2017 |
|
2018 |
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales, net |
$ |
62,312 |
|
|
|
35,559 |
|
|
$ |
119,971 |
|
|
|
63,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
1,154 |
|
|
|
775 |
|
|
|
2,328 |
|
|
|
1,421 |
|
Research
and development |
|
20,543 |
|
|
|
7,876 |
|
|
|
37,593 |
|
|
|
15,052 |
|
Selling,
general and administrative |
|
19,981 |
|
|
|
14,113 |
|
|
|
38,421 |
|
|
|
29,150 |
|
Total operating
expenses |
$ |
41,678 |
|
|
$ |
22,764 |
|
|
$ |
78,342 |
|
|
$ |
45,623 |
|
Income from
operations |
|
20,634 |
|
|
|
12,795 |
|
|
|
41,629 |
|
|
|
17,535 |
|
Interest and other
income (expense) |
|
562 |
|
|
|
(98 |
) |
|
|
856 |
|
|
|
(323 |
) |
Income before income
taxes |
|
21,196 |
|
|
|
12,697 |
|
|
|
42,485 |
|
|
|
17,212 |
|
Income tax expense |
|
(3,000 |
) |
|
|
(50 |
) |
|
|
(6,830 |
) |
|
|
(177 |
) |
Net
income |
$ |
18,196 |
|
|
$ |
12,647 |
|
|
$ |
35,655 |
|
|
$ |
17,035 |
|
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain
(loss) on available-for-sale securities, net of tax impact of $(7),
$0, $41 and $0, respectively |
|
25 |
|
|
|
(5 |
) |
|
|
(127 |
) |
|
|
(17 |
) |
Total
comprehensive income |
$ |
18,221 |
|
|
$ |
12,642 |
|
|
$ |
35,528 |
|
|
$ |
17,018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net
income per common share |
$ |
0.16 |
|
|
$ |
0.11 |
|
|
$ |
0.31 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net
income per common share |
$ |
0.14 |
|
|
$ |
0.10 |
|
|
$ |
0.28 |
|
|
$ |
0.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute
basic net income per share |
|
115,492 |
|
|
|
113,249 |
|
|
|
115,189 |
|
|
|
113,059 |
|
Shares used to compute
diluted net income per share |
|
127,515 |
|
|
|
123,011 |
|
|
|
127,610 |
|
|
|
122,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS INCORPORATED |
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME |
(in
thousands, except per share amounts) (Unaudited) |
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income |
|
$ |
18,196 |
|
|
$ |
12,647 |
|
|
$ |
35,655 |
|
|
$ |
17,035 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash expenses
(benefits): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
1,963 |
|
|
|
850 |
|
|
|
3,427 |
|
|
|
1,503 |
|
Selling,
general and administrative |
|
|
4,054 |
|
|
|
2,355 |
|
|
|
7,544 |
|
|
|
4,403 |
|
Total
stock-based compensation |
|
|
6,017 |
|
|
|
3,205 |
|
|
|
10,971 |
|
|
|
5,906 |
|
Accretion
of interest expense related to debt obligation |
|
|
— |
|
|
|
149 |
|
|
|
— |
|
|
|
419 |
|
Deferred
tax assets |
|
|
2,474 |
|
|
|
— |
|
|
|
5,643 |
|
|
|
— |
|
Income
tax effect of non-GAAP adjustments(1) |
|
|
(1,264 |
) |
|
|
— |
|
|
|
(2,304 |
) |
|
|
— |
|
Non-GAAP net income, as
adjusted for non-cash expenses |
|
$ |
25,423 |
|
|
$ |
16,001 |
|
|
$ |
49,965 |
|
|
$ |
23,360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic net income
per share |
|
$ |
0.16 |
|
|
$ |
0.11 |
|
|
$ |
0.31 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP diluted net income
per share |
|
$ |
0.14 |
|
|
$ |
0.10 |
|
|
$ |
0.28 |
|
|
$ |
0.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net
income per share, as adjusted for non-cash expenses |
|
$ |
0.22 |
|
|
$ |
0.14 |
|
|
$ |
0.43 |
|
|
$ |
0.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP diluted net
income per share, as adjusted for non-cash expenses |
|
$ |
0.20 |
|
|
$ |
0.13 |
|
|
$ |
0.39 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute
basic net income per share |
|
|
115,492 |
|
|
|
113,249 |
|
|
|
115,189 |
|
|
|
113,059 |
|
Shares used to compute
diluted net income per share |
|
|
127,515 |
|
|
|
123,011 |
|
|
|
127,610 |
|
|
|
122,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)Calculated by applying the statutory tax rate to the pre-tax,
non-discrete, non-GAAP adjustments.
CONTACT:Charles RobbChief Financial OfficerCorcept
Therapeutics650-688-8783crobb@corcept.comwww.corcept.com
Photos accompanying this announcement are available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/06e45b60-50ce-4fdf-8748-1ce8dbd93b05
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