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- and year-ended
December 31, 2017 and provided interim data from its Phase 2 trial
of relacorilant to treat patients with hypercortisolism.
Financial Highlights
- 2017 revenue of $159.2 million, an increase of 96 percent from
2016
- Fourth quarter revenue of $53.3 million, an increase of 124
percent from fourth quarter 2016
- 2017 GAAP net income of $1.04 per share, compared to $0.07 per
share in 2016
- Fourth quarter GAAP net income of $0.77 per share, compared to
$0.04 per share in fourth quarter 2016
- Cash and investments at December 31, 2017 of $104.0
million
- 2018 revenue guidance of $275 – 300 million
Corcept’s 2017 revenue was $159.2 million,
compared to $81.3 million in 2016. Fourth quarter revenue was
$53.3 million, compared to $23.8 million in the fourth quarter of
2016.
GAAP net income was $129.1 million for the year
and $98.3 million in the fourth quarter of 2017, compared to
$8.1 million for the year and $4.6 million in the fourth quarter of
2016. Fourth quarter 2017 net income included a one-time,
non-cash gain of $76.7 million from recognition of the company’s
deferred tax assets. Excluding this non-cash gain and
non-cash expenses related to stock-based compensation and implied
interest on the company's capped royalty obligation (which it
retired in July 2017), Corcept generated $24.7 million of non-GAAP
net income in the fourth quarter, compared to $6.9 million in the
fourth quarter of 2016. For the full-year, non-GAAP net income was
$63.3 million, compared to $17.1 million in 2016. A
reconciliation of GAAP to non-GAAP net income is set forth
below.
Operating expenses increased to $31.6 million in
the fourth quarter 2017, from $18.8 million in the fourth quarter
2016, primarily due to increased spending to develop the company’s
proprietary, selective cortisol modulators, including relacorilant,
CORT125281 and CORT118335. Costs resulting from revenue
growth also increased, primarily compensation expense for the
company’s expanded sales force and the cost of dispensing Korlym®
to more patients.
Cash and investments increased $27.4 million in
the fourth quarter, to $104.0 million. This balance does not
include $12.9 million delivered to Corcept in January 2018 pursuant
to the settlement of litigation with the company’s former specialty
pharmacy.
“We produced outstanding results in 2017 and
expect strong performance in 2018. Physicians are
increasingly aware of the risks of not treating hypercortisolism
and are more frequently screening patients for the disease.
For many of the patients they identify, physicians are choosing
cortisol modulation as the optimum medical treatment,” said Joseph
K. Belanoff, MD, Corcept’s Chief Executive Officer.
Relacorilant Phase 2 Trial Interim
Results
- Top-line findings from first 17 patients enrolled in this trial
(“Low Dose Cohort”)
- Dosing: each patient received 100 mg/day of relacorilant for
four weeks, then 150 mg/day for four weeks, then 200 mg/day for
four weeks
- Statistically significant, dose-dependent improvements in
glucose tolerance and serum osteocalcin (a marker of bone growth
suppressed by excess cortisol activity)
- Five millimeters or greater reduction in blood pressure in 45
percent of patients with uncontrolled hypertension
- No evidence of progesterone receptor affinity; no serious
adverse events
- Testing of higher doses continues; results expected in second
quarter
- Phase 3 trial expected to start in second half of 2018
“The data emerging from relacorilant’s Phase 2
trial point to a major clinical advance – a medication
offering the benefits of potent cortisol modulation, but without
Korlym’s serious off-target effects,” said Dr. Belanoff.
“Relacorilant’s activity in these patients is
extremely encouraging,” said Robert S. Fishman, MD, Corcept’s Chief
Medical Officer. “The medication’s safety profile was
excellent: no serious adverse events and, as expected, no signs of
progesterone receptor affinity.
“We were pleasantly surprised that even at
relatively modest doses administered for only 12 weeks, many
patients in the low dose cohort responded: Patients with
hyperglycemia demonstrated improved glucose tolerance as measured
by the oral glucose tolerance test. Levels of osteocalcin – a
marker of bone formation – also improved, which is important
because hypercortisolism frequently causes osteoporosis. For
both measures, these results grew more pronounced as the dose of
relacorilant increased, with the highest dose reaching statistical
significance compared to baseline (see Figures 1 and 2).
Forty-five percent of patients (five of eleven) with uncontrolled
hypertension showed a five millimeter or greater reduction in
systolic or diastolic blood pressure as measured by 24-hour
ambulatory monitoring – a result at 12 weeks that was similar to
the one we saw in Korlym’s pivotal trial after six months of
treatment.
An infographic accompanying this announcement are available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/169da0f1-9927-4e2b-bed4-0b7a6568c65a
We expect that these measures will show an even
greater effect size in the trial’s final cohort of patients, who
are receiving higher doses of the medication, and look forward to
sharing the full results at scientific conferences later in the
year.”
Other Clinical Developments
“Relacorilant’s promising initial Phase 2
results should not overshadow the progress in our other development
programs,” added Dr. Fishman. “CORT118335’s Phase 1 trial
continues. We plan to initiate Phase 2 trials of this
compound as a treatment for patients with antipsychotic-induced
weight gain and non-alcoholic steatotic hepatitis (“NASH”) by
year-end. CORT125281 is now being tested in patients with
castration-resistant prostate cancer. Finally, our Phase 1/2
trial of relacorilant plus Abraxane® to treat patients with solid
tumors is generating encouraging early results, which will be
released in detail later this year.”
Conference Call
Corcept will hold a conference call February 22,
2017, at 5:00 pm Eastern Time (2:00 pm Pacific Time). To
participate, dial 1-800-289-0459 from the United States or
1-323-794-2558 internationally ten minutes before the start of the
call. The passcode is 094798. A replay will be
available through March 8, 2018 at 1-888-203-1112 from the United
States and 1-719-457-0820 internationally. The passcode will be
1581123.
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
include 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 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 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,
non-GAAP basic net income per share and non-GAAP diluted net income
per share that exclude non-cash stock-based compensation expense
and the interest expense of the company’s capped royalty
obligation. 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 in this press release, other than
statements of historical fact, are forward-looking
statements. Such statements are subject to risks and
uncertainties that might cause actual results to differ materially
from those they express or imply and should be considered in light
of various important factors, including, but 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, risks related to
the development of our product candidates, regulatory approvals and
other requirements. These and other risks and uncertainties
are set forth in our SEC filings, which are available at our
website and the SEC’s website. Forward-looking statements in this
press release include those concerning our 2018 revenue guidance,
the pace of Korlym’s acceptance by physicians and patients, interim
results of relacorilant’s Phase 2 trial and our preparations for
Phase 3, our development of relacorilant as a treatment for solid
tumors and our development of CORT125281, CORT118335 and our other
product candidates. We disclaim any intention or duty to
update these forward-looking statements.
Abraxane® is a registered trademark of
Celgene Corporation.
CORCEPT THERAPEUTICS INCORPORATED |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In
thousands) |
|
|
December 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash and
investments |
|
$ |
104,025 |
|
|
$ |
51,536 |
|
Trade
receivables, net of allowances |
|
|
15,300 |
|
|
|
9,860 |
|
Inventory |
|
|
8,376 |
|
|
|
5,164 |
|
Other
receivable |
|
|
12,896 |
|
|
|
— |
|
Deferred
tax assets |
|
|
76,703 |
|
|
|
— |
|
Other
assets |
|
|
3,237 |
|
|
|
2,193 |
|
Total
assets |
|
$ |
220,537 |
|
|
$ |
68,753 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
8,579 |
|
|
$ |
2,290 |
|
Long-term
obligation |
|
|
— |
|
|
|
14,664 |
|
Other
liabilities |
|
|
20,990 |
|
|
|
10,420 |
|
Stockholder's equity |
|
|
190,968 |
|
|
|
41,379 |
|
Total
liabilities and stockholders’ equity |
|
$ |
220,537 |
|
|
$ |
68,753 |
|
|
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS INCORPORATED |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except per share amounts) |
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales, net |
|
|
53,280 |
|
|
|
23,811 |
|
|
|
159,201 |
|
|
|
81,321 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
1,156 |
|
|
|
561 |
|
|
|
3,554 |
|
|
|
2,058 |
|
Research
and Development |
|
|
13,632 |
|
|
|
6,484 |
|
|
|
40,376 |
|
|
|
23,844 |
|
Selling,
general and administrative |
|
|
16,795 |
|
|
|
11,760 |
|
|
|
62,416 |
|
|
|
45,240 |
|
Total operating
expenses |
|
$ |
31,583 |
|
|
$ |
18,805 |
|
|
$ |
106,346 |
|
|
$ |
71,142 |
|
Income from
operations |
|
|
21,697 |
|
|
|
5,006 |
|
|
|
52,855 |
|
|
|
10,179 |
|
Interest income and
other (expense) |
|
|
188 |
|
|
|
(410 |
) |
|
|
(49 |
) |
|
|
(2,039 |
) |
Income before income
taxes |
|
|
21,885 |
|
|
|
4,597 |
|
|
|
52,806 |
|
|
|
8,140 |
|
Income tax benefit |
|
|
76,445 |
|
|
|
— |
|
|
|
76,316 |
|
|
|
— |
|
Net
income |
|
$ |
98,330 |
|
|
$ |
4,597 |
|
|
$ |
129,122 |
|
|
$ |
8,140 |
|
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized
gain/(loss) on available-for-sale securities |
|
|
(61 |
) |
|
|
— |
|
|
|
(75 |
) |
|
|
— |
|
Total
comprehensive income |
|
$ |
98,269 |
|
|
$ |
4,597 |
|
|
$ |
129,047 |
|
|
$ |
8,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net
income per common share |
|
$ |
0.86 |
|
|
$ |
0.04 |
|
|
$ |
1.14 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net
income per common share |
|
$ |
0.77 |
|
|
$ |
0.04 |
|
|
$ |
1.04 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute
basic net income per share |
|
|
114,370 |
|
|
|
111,902 |
|
|
|
113,527 |
|
|
|
110,566 |
|
Shares used to compute
diluted net income per share |
|
|
127,361 |
|
|
|
118,866 |
|
|
|
124,515 |
|
|
|
116,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS INCORPORATED |
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME |
(in thousands, except per share amounts) |
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income |
|
$ |
98,330 |
|
|
$ |
4,597 |
|
|
$ |
129,122 |
|
|
$ |
8,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash expenses
(benefits): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
1,191 |
|
|
|
433 |
|
|
|
3,743 |
|
|
|
1,312 |
|
Selling,
general and administrative |
|
|
2,640 |
|
|
|
1,525 |
|
|
|
9,618 |
|
|
|
5,746 |
|
Total
stock-based compensation |
|
|
3,831 |
|
|
|
1,958 |
|
|
|
13,361 |
|
|
|
7,058 |
|
Accretion
of interest expense related to long-term obligation |
|
|
— |
|
|
|
367 |
|
|
|
456 |
|
|
|
1,929 |
|
Deferred
tax assets |
|
|
(76,703 |
) |
|
|
— |
|
|
|
(76,703 |
) |
|
|
— |
|
Income
tax effect of non-GAAP adjustments1 |
|
|
(805 |
) |
|
|
— |
|
|
|
(2,902 |
) |
|
|
— |
|
Non-GAAP net income,
adjusted for non-cash items |
|
$ |
24,653 |
|
|
$ |
6,922 |
|
|
$ |
63,334 |
|
|
$ |
17,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic net income
per share |
|
$ |
0.86 |
|
|
$ |
0.04 |
|
|
$ |
1.14 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP diluted net income
per share |
|
$ |
0.77 |
|
|
$ |
0.04 |
|
|
$ |
1.04 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net
income per share, adjusted for non-cash items |
|
$ |
0.22 |
|
|
$ |
0.06 |
|
|
$ |
0.56 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP diluted net
income per share, adjusted for non-cash items |
|
$ |
0.19 |
|
|
$ |
0.06 |
|
|
$ |
0.51 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute
basic net income per share |
|
|
114,370 |
|
|
|
111,902 |
|
|
|
113,527 |
|
|
|
110,566 |
|
Shares used to compute
diluted net income per share |
|
|
127,361 |
|
|
|
118,866 |
|
|
|
124,515 |
|
|
|
116,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1Calculated by applying the applicable statutory tax rate.
CONTACT:Charles RobbChief Financial OfficerCorcept
Therapeutics650-688-8783crobb@corcept.comwww.corcept.com
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