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 results for the quarter ended June 30,
2020.
Financial Highlights
- Revenue of $88.6 million, a 23 percent increase from second
quarter 2019
- GAAP diluted net income of $0.23 per share, compared to $0.17
per share in second quarter 2019
- Non-GAAP diluted net income of $0.32 per share, compared to
$0.25 per share in second quarter 2019
- Cash and investments of $409.6 million, compared to $349.0
million at March 31, 2020
- Reaffirmed 2020 revenue guidance of $355 – 375 million
Revenue was $88.6 million in the second quarter,
compared to $72.3 million in the second quarter of 2019.
Second quarter revenue was $4.7 million lower than in the
first quarter, primarily because in March 2020 some patients
refilled their prescriptions a few days earlier than usual as a
safeguard against pandemic-related delays. These safety
stocks were consumed in the second quarter. This shift
in refill timing increased shipments of Korlym tablets in the first
quarter and decreased them by a similar amount in the second
quarter.
We reaffirm our 2020 revenue guidance of $355 –
375 million.
Second quarter GAAP net income was $28.3
million, compared to $20.2 million in the same period last year.
Excluding non-cash expenses related to stock-based
compensation and the utilization of deferred tax assets, together
with related income tax effects, non-GAAP net income in the second
quarter was $39.7 million, compared to $31.0 million in the second
quarter of 2019. A reconciliation of GAAP to non-GAAP net
income is included below.
Second quarter operating expenses were $53.3
million, compared to $47.6 million in the second quarter of 2019,
primarily due to increased spending to conduct clinical trials in
Cushing’s syndrome, antipsychotic-induced weight gain and solid
tumors and to formulate and manufacture the company’s proprietary,
selective cortisol modulators and to increased employee recruiting
and compensation expense.
Cash and investments were $409.6 million at June
30, 2020, an increase of $60.6 million from March 31, 2020.
“Patients with Cushing’s syndrome are at
elevated risk of infection with the novel coronavirus,” said Joseph
K. Belanoff, MD, Corcept’s Chief Executive Officer. “Our
clinical specialists, medical science liaisons and patient
advocates have done an excellent job helping physicians provide the
care these patients need, despite the challenges posed by the
Covid-19 pandemic.
“The pandemic’s impact on Corcept has been
varied,” Dr. Belanoff added. “As our first and second quarter
results showed, pandemic-related changes in patient refill choices
can shift revenue from one quarter to another. More
fundamentally, while the heightened vulnerability of patients with
Cushing’s syndrome to Covid-19 has caused patients to stay on
therapy, which tends to increase demand for Korlym, it remains
difficult for doctors to arrange the tests and on-going monitoring
needed to diagnose new patients and optimize their care. In
addition, many patients are reluctant to leave their homes, even to
visit their doctor. And opportunities for our clinical
specialists to meet with physicians in person remain limited,
although telephone and video conference contact is becoming more
common.
“We expect that these countervailing forces will
continue in coming quarters, but also expect any changes to be
manageable and reiterate our 2020 revenue guidance of $355 – 375
million.”
Cushing’s Syndrome
- Phase 3 trial of relacorilant in patients with all etiologies
of Cushing’s syndrome (GRACE) continues at 60 sites in the United
States, Europe and Israel; NDA submission planned in second quarter
2022
- Enrollment underway in Phase 3 trial of relacorilant in
patients with Cushing’s syndrome of adrenal origin (GRADIENT)
“Although the Covid-19 pandemic has slowed
patient enrollment and clinical site activation, our Cushing’s
syndrome program continues to make important progress,” said
Andreas Grauer, MD, Corcept’s Chief Medical Officer. “We
opened five additional clinical sites in GRACE, our pivotal trial
of relacorilant to treat patients with all etiologies of Cushing’s
syndrome, bringing the total to 60. Enrollment activity has
increased, particularly in Europe, where pandemic-related
restrictions have eased. We plan to submit relacorilant’s
NDA, based on the results of GRACE, in the second quarter of
2022.
“In addition, enrollment has begun in GRADIENT,
our double-blind, placebo-controlled, Phase 3 trial with a planned
total of 130 patients whose Cushing’s syndrome is caused by an
adrenal adenoma or adrenal hyperplasia.1 GRADIENT is the first
controlled clinical trial of medical treatment in this etiology of
the disease.
Solid Tumors
- Completed enrollment in controlled, Phase 2 trial of
relacorilant plus nab-paclitaxel in patients with metastatic
ovarian cancer; results expected in first half 2021
- Initiated Phase 3 trial of relacorilant plus nab-paclitaxel in
patients with metastatic pancreatic cancer (RELIANT)
- Selection of optimum dose of exicorilant plus enzalutamide in
patients with castration-resistant prostate cancer expected by
year-end
- Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor
pembrolizumab in patients with metastatic or unresectable adrenal
cancer expected to start in third quarter 2020
“Our development of relacorilant as a potential
treatment for solid tumors recently achieved two important
milestones,” said Dr. Grauer. “We completed enrollment in our
controlled, Phase 2 trial of relacorilant combined with
nab-paclitaxel to treat patients with metastatic ovarian
cancer. We also initiated RELIANT, our Phase 3 trial of
relacorilant plus nab-paclitaxel in patients with metastatic
pancreatic cancer. Data from our open-label, Phase 1/2 trial
in patients with these tumors were very encouraging.2
Replicating those results in these larger, more rigorous trials
would be an important medical advance.”
Our controlled, Phase 2 trial of relacorilant
plus nab-paclitaxel in patients with metastatic, platinum-resistant
ovarian cancer has enrolled its goal of 178 patients, at 28 sites
in the United States, Canada and Europe. Participants were
randomly assigned to receive either relacorilant plus
nab-paclitaxel or nab-paclitaxel alone. The trial’s primary
endpoint is progression free survival, with secondary endpoints
including objective response rate and duration of objective
response. Data is expected in the first half of next
year.
RELIANT has a planned enrollment of 80 patients
with metastatic pancreatic cancer, with an interim analysis of data
from the first 40 patients. Each patient will receive
relacorilant plus nab-paclitaxel. The primary endpoint is
objective response rate, with secondary endpoints including
progression-free survival and duration of response. RELIANT
will be conducted at 20 sites in the United States. We
believe sufficiently positive results would support accelerated
approval by the FDA.
“In the third quarter, we plan to initiate an
open-label, 20-patient, Phase 1b trial of relacorilant combined
with the PD-1 checkpoint inhibitor pembrolizumab in patients with
metastatic or unresectable adrenal cancer that produces excess
cortisol,” said Dr. Grauer. “These patients respond poorly to
pembrolizumab monotherapy and also suffer from Cushing’s
syndrome. By modulating the effects of excess cortisol,
including cortisol-induced immune suppression, relacorilant may
both treat the symptoms of Cushing’s syndrome and allow
pembrolizumab achieve its full cancer-killing effect.”
Metabolic Diseases
- Enrollment continues in double-blind, placebo-controlled, Phase
2 trial of miricorilant to reverse recent APIWG (GRATITUDE)
- Double-blind, placebo-controlled Phase 2 trial (GRATITUDE 2) of
miricorilant to reverse long-standing antipsychotic-induced weight
gain (APIWG) planned to start in third quarter 2020
- Double-blind, placebo-controlled Phase 2 trial of miricorilant
in patients with non-alcoholic steatohepatitis (NASH) planned to
start in fourth quarter 2020
“Miricorilant has shown great promise as a
treatment for APIWG,” said Dr. Grauer. “In our Phase 1b
trial, healthy subjects given olanzapine plus miricorilant gained
less weight and had lower triglycerides and less sharply elevated
liver enzymes than subjects who received olanzapine plus placebo –
despite being treated for only two weeks. We hope to confirm
and extend these results in the GRATITUDE trials.
“Our on-going GRATITUDE trial is testing the
ability of miricorilant to reduce recent weight gain caused by
antipsychotic medications in 100 patients with schizophrenia,”
added Dr. Grauer. “Study participants continue to receive
their established dose of antipsychotic medication and either 600
milligrams of miricorilant or placebo for 12 weeks. Our
second trial, GRATITUDE 2 will test the same effect in patients
with long-standing APIWG.
“Completion of formulation work for miricorilant
has allowed us to advance by one quarter the start of our second
Phase 2 trial in patients with APIWG and our first Phase 2 trial in
patients with NASH,” said Dr. Grauer.
Conference
Call
We will hold a conference call on August 4th,
2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To
participate, dial 1-800-353-6461 from the United States or
1-334-323-0501 internationally approximately ten minutes before the
start of the call (passcode 6800706). A replay will be
available through August 18, 2020 at 1-888-203-1112 in the United
States and 1-719-457-0820 internationally (passcode 6800706).
About Corcept Therapeutics
Corcept is 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 hormone cortisol. Korlym® was the first drug approved by the
U.S. Food and Drug Administration for patients with Cushing’s
syndrome. We have discovered a large portfolio of proprietary
compounds that selectively modulate the effects of cortisol. We own
extensive United States and foreign intellectual property covering
the composition of our selective cortisol modulators and the use of
cortisol modulators to treat a variety of serious disorders.
GAAP Measures of Net Income
To supplement our financial results presented on
a GAAP basis, we use non-GAAP measures of net income, basic net
income per share and diluted net income per share that exclude the
following non-cash expenses – (i) stock-based compensation, (ii)
our use of deferred tax assets to offset current tax expense and
(iii) related income tax effects. We believe these non-GAAP
measures help investors evaluate our financial performance and
potential future results. Our non-GAAP measures may be different
from, and not directly comparable to, those used by other
companies. They are not a substitute for comparable GAAP measures
and should not be considered in isolation. Investors should read
our non-GAAP presentation in conjunction with our financial
statements prepared in accordance with GAAP.
Forward-Looking Statements
Statements in this press release, other than
statements of historical fact, are forward-looking statements based
on our current plans and expectations that are subject to risks and
uncertainties that might cause our actual results to differ
materially from those statements express or imply. These risks and
uncertainties include, but are not limited to, our ability to
operate our business and achieve our goals during the Covid-19
pandemic and 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 their clinical attributes,
regulatory approvals, mandates and 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 2020 revenue guidance; the impact of the Covid-19
pandemic on our operations, financial performance and clinical
development programs; the progress, enrollment, timing, design and
results of our clinical trials; and the clinical and commercial
attributes of relacorilant, exicorilant and miricorilant. We
disclaim any intention or duty to update forward-looking statements
made in this press release.
CORCEPT THERAPEUTICS INCORPORATEDCONDENSED
CONSOLIDATED BALANCE SHEETS(In thousands, except per share
data) |
|
|
June 30, 2020 |
|
December 31, 2019 (1) |
|
|
(Unaudited) |
|
|
|
Assets |
|
|
|
|
Cash and investments |
$ |
409,558 |
|
|
$ |
315,314 |
|
Trade receivables, net of allowances |
22,725 |
|
|
|
19,928 |
|
|
Inventory |
16,120 |
|
|
|
17,405 |
|
|
Operating lease right-of-use asset |
3,472 |
|
|
|
3,446 |
|
|
Deferred tax assets, net |
35,470 |
|
|
|
45,677 |
|
|
Other assets |
10,478 |
|
|
|
10,542 |
|
|
Total assets |
$ |
497,823 |
|
|
$ |
412,312 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
Accounts payable |
$ |
6,304 |
|
|
$ |
7,537 |
|
Operating lease liabilities |
3,505 |
|
|
|
3,461 |
|
|
Other liabilities |
34,316 |
|
|
|
30,132 |
|
|
Stockholders' equity |
453,698 |
|
|
|
371,182 |
|
|
Total liabilities and stockholders’ equity |
$ |
497,823 |
|
|
$ |
412,312 |
|
|
|
|
|
|
(1) Derived from audited
financial statements at that date |
|
|
|
|
CORCEPT THERAPEUTICS INCORPORATEDCONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME(In
thousands, except per share data) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues |
|
|
|
|
|
|
|
Product revenue, net |
$ |
88,565 |
|
|
|
$ |
72,257 |
|
|
|
$ |
181,812 |
|
|
|
$ |
137,086 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of sales |
1,234 |
|
|
|
1,377 |
|
|
|
3,112 |
|
|
|
2,617 |
|
|
Research and development |
26,497 |
|
|
|
21,656 |
|
|
|
52,620 |
|
|
|
41,900 |
|
|
Selling, general and administrative |
25,572 |
|
|
|
24,591 |
|
|
|
53,107 |
|
|
|
48,980 |
|
|
Total operating expenses |
$ |
53,303 |
|
|
|
$ |
47,624 |
|
|
|
$ |
108,839 |
|
|
|
$ |
93,497 |
|
|
Income from operations |
35,262 |
|
|
|
24,633 |
|
|
|
72,973 |
|
|
|
43,589 |
|
|
Interest and other income |
1,010 |
|
|
|
1,178 |
|
|
|
2,481 |
|
|
|
2,275 |
|
|
Income before income
taxes |
36,272 |
|
|
|
25,811 |
|
|
|
75,454 |
|
|
|
45,864 |
|
|
Income tax expense |
(7,945 |
) |
|
|
(5,625 |
) |
|
|
(17,062 |
) |
|
|
(7,404 |
) |
|
Net
income |
$ |
28,327 |
|
|
|
$ |
20,186 |
|
|
|
$ |
58,392 |
|
|
|
$ |
38,460 |
|
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
Net unrealized gain on
available-for-sale investments, net of tax impact of $(170), $(73),
$(190) and $(124), respectively |
545 |
|
|
|
227 |
|
|
|
606 |
|
|
|
391 |
|
|
Foreign currency translation
loss, net of tax |
(15 |
) |
|
|
— |
|
|
|
(27 |
) |
|
|
— |
|
|
Total comprehensive
income |
$ |
28,857 |
|
|
|
$ |
20,413 |
|
|
|
$ |
58,971 |
|
|
|
$ |
38,851 |
|
|
|
|
|
|
|
|
|
|
Basic net income per
share |
$ |
0.25 |
|
|
|
$ |
0.18 |
|
|
|
$ |
0.51 |
|
|
|
$ |
0.34 |
|
|
|
|
|
|
|
|
|
|
Diluted net income per
share |
$ |
0.23 |
|
|
|
$ |
0.17 |
|
|
|
$ |
0.48 |
|
|
|
$ |
0.31 |
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic
net income per common share |
115,006 |
|
|
|
114,340 |
|
|
|
114,790 |
|
|
|
114,590 |
|
|
Shares used in computing
diluted net income per common share |
123,234 |
|
|
|
121,783 |
|
|
|
122,756 |
|
|
|
122,831 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORCEPT THERAPEUTICS
INCORPORATEDRECONCILIATION OF GAAP TO NON-GAAP NET
INCOME(In thousands, except per share data) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
GAAP net income |
$ |
28,327 |
|
|
$ |
20,186 |
|
|
$ |
58,392 |
|
|
$ |
38,460 |
|
|
|
|
|
|
|
|
|
Non-cash expenses
(benefits) |
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
Cost of sales |
15 |
|
|
55 |
|
|
38 |
|
|
83 |
|
Research and development |
2,794 |
|
|
2,505 |
|
|
5,399 |
|
|
4,484 |
|
Selling, general and administrative |
5,680 |
|
|
5,176 |
|
|
10,970 |
|
|
9,865 |
|
Total stock-based compensation |
8,489 |
|
|
7,736 |
|
|
16,407 |
|
|
14,432 |
|
Deferred income taxes |
4,922 |
|
|
4,908 |
|
|
10,017 |
|
|
5,834 |
|
Income tax effect of non-GAAP adjustments (1) |
(2,037 |
) |
|
(1,857 |
) |
|
(3,938 |
) |
|
(3,464 |
) |
Non-GAAP net income,
adjusted for non-cash expenses |
$ |
39,701 |
|
|
$ |
30,973 |
|
|
$ |
80,878 |
|
|
$ |
55,262 |
|
|
|
|
|
|
|
|
|
GAAP basic net income
per share |
$ |
0.25 |
|
|
$ |
0.18 |
|
|
$ |
0.51 |
|
|
$ |
0.34 |
|
|
|
|
|
|
|
|
|
GAAP diluted net
income per share |
$ |
0.23 |
|
|
$ |
0.17 |
|
|
$ |
0.48 |
|
|
$ |
0.31 |
|
|
|
|
|
|
|
|
|
Non-GAAP basic net
income per share, adjusted for non-cash expenses |
$ |
0.35 |
|
|
$ |
0.27 |
|
|
$ |
0.70 |
|
|
$ |
0.48 |
|
|
|
|
|
|
|
|
|
Non-GAAP diluted net
income per share, adjusted for non-cash expenses |
$ |
0.32 |
|
|
$ |
0.25 |
|
|
$ |
0.66 |
|
|
$ |
0.45 |
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income per share |
115,006 |
|
|
114,340 |
|
|
114,790 |
|
|
114,590 |
|
Shares used in
computing diluted net income per share |
123,234 |
|
|
121,783 |
|
|
122,756 |
|
|
122,831 |
|
|
|
|
|
|
|
|
|
(1) Calculated by
applying the statutory tax rate to the pre-tax, non-discrete,
non-GAAP adjustments. |
________________________
1 See our 2020 ENDO poster at the Research & Pipeline /
Publications tab of our website.2 See our ASCO poster at the
Investors / Events tab of our website.
CONTACT:Christopher S. James, MDDirector,
Investor RelationsCorcept
Therapeutics650-684-8725cjames@corcept.comwww.corcept.com
Corcept Therapeutics (NASDAQ:CORT)
Historical Stock Chart
From Apr 2024 to May 2024
Corcept Therapeutics (NASDAQ:CORT)
Historical Stock Chart
From May 2023 to May 2024