Corcept Therapeutics Incorporated (NASDAQ: CORT), a
commercial-stage company engaged in the discovery and development
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 March
31, 2019.
Financial Highlights
- Revenue of $64.8 million, a 12
percent increase from first quarter 2018
- Fully-diluted GAAP net income of
$0.15 per share, compared to $0.14 per share in first quarter
2018
- Fully-diluted non-GAAP net income
of $0.20 per share, compared to $0.19 per share in first quarter
2018
- Cash and investments of $215.7
million, a $9.0 million increase from year-end 2018
- Reaffirmed 2019 revenue guidance of
$285 – $315 million
Corcept reported quarterly revenue of $64.8
million, compared to $57.7 million in the first quarter of 2018.
First quarter GAAP net income was $18.3 million, compared to $17.5
million in the same period last year. Excluding non-cash expenses
related to stock-based compensation, utilization of deferred tax
assets and related income tax effects, non-GAAP net income in the
first quarter was $24.3 million, compared to $24.5 million in the
first quarter of 2018. A reconciliation of GAAP to non-GAAP net
income is included below.
First quarter operating expenses were $45.9
million, compared to $36.7 million in the first quarter of 2018,
primarily due to an increase in research and development personnel
and increased spending to advance new compounds towards the clinic
and to formulate and manufacture relacorilant, CORT118335 and
CORT125281.
Cash and investments were $215.7 million at
March 31, 2019, an increase of $9.0 million from year-end. This
increase was after the expenditure of $13.6 million in the first
quarter to repurchase 1.2 million shares of common stock. At March
31, 2019, $62.8 million remained available under Corcept’s stock
repurchase program.
The company reaffirmed 2019 revenue guidance of
$285 – $315 million.
“As in prior years, our first quarter revenue
was reduced as payors forced patients to secure reauthorization of
their insurance,” said Joseph K. Belanoff, MD, Corcept’s Chief
Executive Officer. “Our first quarter revenue was also reduced by
the requirement that we cover a portion of the ‘donut hole’ in
Medicare Part D insurance plans – a portion that, by statute,
increased significantly this year. No patient’s care was
interrupted, because we provide Korlym® at no cost until coverage
is restored. The number of patients receiving Korlym continues to
grow.
“Awareness of Cushing’s syndrome and the
importance of screening more widely for the disorder is
increasing,” Dr. Belanoff added. “Our goal is to educate physicians
about the benefits of cortisol modulation with Korlym and, should
it continue to generate positive clinical data and we secure FDA
approval, relacorilant, Korlym’s planned successor. We
believe relacorilant has the potential to offer significant
benefits – even beyond what we see with Korlym.”
Clinical Highlights
- Dosing continues in Phase 3 trial
of relacorilant in patients with Cushing’s syndrome (“GRACE”)
- European Medicines Agency (“EMA”)
recommends orphan designation for relacorilant to treat patients
with Cushing’s syndrome
- Dosing initiated in double-blind,
placebo-controlled, Phase 1b trial of CORT118335 for prevention of
antipsychotic-induced weight gain; Phase 2 trials in reversal of
antipsychotic-induced weight gain planned in second half of
2019
- Placebo-controlled, Phase 2 trial
of CORT118335 to treat non-alcoholic steatohepatitis (“NASH”)
planned in second half of 2019
- Data from Phase 1/2 trial of
relacorilant plus Abraxane in solid tumors to be presented at 2019
ASCO Meeting, May 31 – June 4
- Dosing continues in controlled,
Phase 2 trial of relacorilant plus Abraxane® in metastatic ovarian
cancer
- Dosing continues in Phase 1/2 trial
of CORT125281 plus Xtandi® in castration-resistant prostate
cancer
“It is an exciting time to join Corcept,” said
Andreas Grauer, MD, who became Corcept’s Chief Medical Officer in
March 2019. “Three of our proprietary, selective cortisol
modulators have entered the clinic and we are conducting five
clinical trials – in Cushing’s syndrome, solid tumors and
antipsychotic-induced weight gain. Additional trials – in
antipsychotic-induced weight gain and NASH – are planned for later
in the year.”
“Relacorilant’s GRACE trial continues to dose
patients with Cushing’s syndrome and has begun opening sites in
Europe, where many of our Phase 2 patients were enrolled. The EMA’s
recommendation that relacorilant receive orphan drug designation is
especially gratifying. Unlike in the United States, orphan
designation in Europe requires the authorities to find plausible
evidence of a drug’s efficacy and potential to confer significant
clinical benefit compared to already-approved treatments – findings
we hope GRACE will confirm for relacorilant.” (For more about
GRACE, go to cushingresearch.com.)
Corcept presented data from relacorilant’s Phase
2 trial at the 2019 annual meeting of the American Association of
Clinical Endocrinologists (“AACE”) in April. Subjects in the trial
exhibited clinically meaningful improvements in the trial’s key
endpoints – hypertension and glucose control – and in a variety of
secondary endpoints, including weight loss, liver function,
coagulopathy, insulin resistance, cognitive function, mood and
quality of life. Relacorilant was well-tolerated, with the most
common adverse events being those associated with a reduction in
excess cortisol activity. These side effects usually resolve
with continued treatment. There were no instances of abnormal
vaginal bleeding, even in women who had previously experienced
abnormal vaginal bleeding with Korlym. Importantly, there were no
instances of hypokalemia, an adverse event experienced by 44
percent of patients in Korlym’s pivotal trial and a leading cause
of Korlym discontinuation. (Corcept’s AACE presentation is
available at ir.corcept.com/events.)
“Our oncology program is also progressing,” said
Dr. Grauer. “Enrollment has begun in our 180-patient, controlled,
Phase 2 trial of relacorilant plus Abraxane® in patients with
metastatic ovarian cancer. At the ASCO congress this June, we will
present data from our Phase 1/2 trial of relacorilant plus Abraxane
in a variety of solid tumors and discuss our plans in metastatic
pancreatic cancer.”
“Finally, our most promising compound for
metabolic disorders, CORT118335, has entered the clinic. We are
dosing healthy subjects in a placebo-controlled Phase 1b trial in
the prevention of antipsychotic-induced weight gain and plan
to start two placebo-controlled, Phase 2 trials in patients later
this year, as well as a placebo-controlled, Phase 2 trial in
patients with NASH – a precursor of cirrhosis. These disorders
afflict millions of patients and there are no good treatment
options.”
Conference
CallWe will hold a conference call on May 9, 2019,
at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate,
dial 1-800-347-6311 from the United States or 1-323-994-2132
internationally approximately ten minutes before the start of the
call. The passcode will be 4773625. A replay will be available
through May 23, 2019 at 888-203-1112 in the United States and
719-457-0820 internationally. The passcode will be 4773625.
HypercortisolismHypercortisolism, often referred
to as Cushing’s syndrome, is caused by excessive activity of the
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. Hypercortisolism can affect every organ system in the
body and can be lethal if not treated effectively.
About Corcept Therapeutics
IncorporatedCorcept is a commercial-stage company engaged
in the discovery and development of drugs that treat severe
metabolic, oncologic and psychiatric disorders by modulating the
effects of the stress hormone cortisol. Corcept’s approved product,
Korlym®, was the first FDA-approved treatment for patients with
Cushing’s syndrome. Korlym modulates the activity of cortisol at
the glucocorticoid receptor, one of the two receptors to which
cortisol binds. Corcept has discovered a large portfolio of
proprietary compounds that selectively modulate the effects of
cortisol but lack Korlym’s affinity for the progesterone receptor.
Corcept owns extensive intellectual property covering the
composition of its selective cortisol modulators and in the use of
cortisol modulators, including Korlym, to treat a wide variety of
serious disorders.
Non-GAAP Measures of
Net IncomeTo supplement our 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 the following non-cash expenses –
stock-based compensation, our use of deferred tax assets to offset
current tax expense and related income tax effects. We believe
these non-GAAP measures help investors better evaluate our past
financial performance and potential future results. Our non-GAAP
measures should not be considered in isolation or as a substitute
for comparable GAAP measures. Investors should read our non-GAAP
presentation in conjunction with our financial statements prepared
in accordance with GAAP. The non-GAAP measures we use may be
different from, and not directly comparable to, similarly titled
measures used by other companies.
Forward-Looking
StatementsStatements in this press release, other than
statements of historical fact, are forward-looking statements,
which 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 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 availability of competing
treatments, including generic versions of Korlym; our ability to
obtain acceptable prices or adequate insurance coverage and
reimbursement for Korlym; and risks related to the development of
our product candidates, including regulatory approvals, mandates,
oversight and other requirements. These and other risks are set
forth in our SEC filings, which are available at our website and
the SEC’s website. In this press release, forward-looking
statements include those concerning our 2019 revenue guidance,
increasing awareness of Cushing’s syndrome and the importance of
screening more widely for the disorder, and statements
concerning our anticipated increase in Korlym uptake; the progress,
timing, design and results of our development programs, including
the GRACE trial and our other clinical trials; the clinical and
commercial attributes of relacorilant, CORT125281 and CORT118335;
and the scope and protective power of our intellectual property. 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) |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018(1) |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Cash and investments |
|
$ |
215,747 |
|
|
$ |
206,760 |
|
Trade receivables, net of allowances |
|
|
19,218 |
|
|
|
17,588 |
|
Inventory |
|
|
15,360 |
|
|
|
16,242 |
|
Operating right-of-use asset |
|
|
1,465 |
|
|
|
— |
|
Deferred tax assets |
|
|
61,681 |
|
|
|
62,659 |
|
Other assets |
|
|
6,741 |
|
|
|
8,445 |
|
Total assets |
|
$ |
320,212 |
|
|
$ |
311,694 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
9,330 |
|
|
$ |
8,266 |
|
Operating lease liability |
|
|
1,521 |
|
|
|
— |
|
Other liabilities |
|
|
23,606 |
|
|
|
27,546 |
|
Stockholders’ equity |
|
|
285,755 |
|
|
|
275,882 |
|
Total liabilities and stockholders’ equity |
|
$ |
320,212 |
|
|
$ |
311,694 |
|
|
|
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS INCORPORATED |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except per share amounts) |
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
64,829 |
|
|
$ |
57,659 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of sales |
|
|
1,240 |
|
|
|
1,174 |
|
Research and development |
|
|
20,244 |
|
|
|
17,050 |
|
Selling, general and administrative |
|
|
24,389 |
|
|
|
18,440 |
|
Total operating
expenses |
|
$ |
45,873 |
|
|
$ |
36,664 |
|
Income from operations |
|
|
18,956 |
|
|
|
20,995 |
|
Interest and other income |
|
|
1,097 |
|
|
|
294 |
|
Income before income
taxes |
|
|
20,053 |
|
|
|
21,289 |
|
Income tax expense |
|
|
(1,779 |
) |
|
|
(3,830 |
) |
Net
income |
|
$ |
18,274 |
|
|
$ |
17,459 |
|
Other comprehensive
income: |
|
|
|
|
|
|
|
|
Net unrealized income (loss)
on available-for-sale investments, net of tax impact of $(52) and
$48, respectively |
|
|
164 |
|
|
|
(152 |
) |
Total comprehensive
income |
|
$ |
18,438 |
|
|
$ |
17,307 |
|
|
|
|
|
|
|
|
|
|
Basic net income per
common share |
|
$ |
0.16 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
Diluted net income per
common share |
|
$ |
0.15 |
|
|
$ |
0.14 |
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic
net income per share |
|
|
114,844 |
|
|
|
114,882 |
|
Shares used to compute diluted
net income per share |
|
|
123,895 |
|
|
|
127,733 |
|
|
|
|
|
|
|
|
|
|
|
CORCEPT
THERAPEUTICS INCORPORATED |
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME |
(in thousands,
except per share amounts) |
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
GAAP net income |
|
$ |
18,274 |
|
|
$ |
17,459 |
|
|
|
|
|
|
|
|
|
|
Non-cash
expenses/(benefits): |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
28 |
|
|
|
— |
|
Research and development |
|
|
1,979 |
|
|
|
1,464 |
|
Selling, general and administrative |
|
|
4,689 |
|
|
|
3,490 |
|
Total stock-based compensation |
|
|
6,696 |
|
|
|
4,954 |
|
Deferred tax assets |
|
|
926 |
|
|
|
3,169 |
|
Income tax effect of non-GAAP adjustments(1) |
|
|
(1,607 |
) |
|
|
(1,040 |
) |
Non-GAAP net income, as
adjusted for non-cash expenses |
|
$ |
24,289 |
|
|
$ |
24,542 |
|
|
|
|
|
|
|
|
|
|
GAAP basic net income per
share |
|
$ |
0.16 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
GAAP diluted net income per
share |
|
$ |
0.15 |
|
|
$ |
0.14 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income per
share, as adjusted for non-cash expenses |
|
$ |
0.21 |
|
|
$ |
0.21 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP diluted net income
per share, as adjusted for non-cash expenses |
|
$ |
0.20 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic
net income per share |
|
|
114,844 |
|
|
|
114,882 |
|
Shares used to compute diluted
net income per share |
|
|
123,895 |
|
|
|
127,733 |
|
|
|
|
|
|
|
|
|
|
(1)Calculated by applying the statutory tax rate to the pre-tax,
non-discrete, non-GAAP adjustments.
CONTACT:Christopher S. James, MDDirector,
Investor RelationsCorcept
Therapeutics650-684-8725cjames@corcept.comwww.corcept.com
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