Corcept Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update
Financial Results
- Revenue of
$101.7 million , compared to$96.1 million in third quarter 2021 - Tightened 2022 revenue guidance of
$400 –$410 million - Diluted net income per common share of
$0.30 , compared to$0.24 in third quarter 2021 - Cash and investments of
$401.2 million , compared to$382.0 million atJune 30, 2022
Corcept’s third quarter 2022 revenue was
Cash and investments of
“Diagnosing and treating patients with a complex disease such as Cushing’s syndrome requires frequent in-person contact with physicians. Our revenue in the third quarter was affected by fewer than expected in-person interactions as many physician practices have not returned to pre-pandemic patterns of activity. To reflect this near-term challenge, we are tightening our 2022 revenue guidance to
Clinical Development
“Our clinical trials continue to advance and generate data supporting cortisol modulation’s broad therapeutic potential,” added
Oncology
- Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
- Enrollment continues in open-label, Phase 1b trial of relacorilant plus
pembrolizumab in patients with adrenal cancer with cortisol excess - Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer to begin next year in collaboration with the
University of Chicago
“We and our investigators are excited that ROSELLA is active and enrolling patients,” said
Amyotrophic Lateral Sclerosis (ALS)
- Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
“ALS, also known as Lou Gehrig’s disease, is a devastating neuromuscular illness with an urgent need for better treatment,” said
Metabolic Diseases
- Enrollment completed in GRATITUDE and GRATITUDE II – two double-blind, placebo-controlled Phase 2 trials of miricorilant to reverse recent and long-standing antipsychotic-induced weight gain (AIWG) – data from both trials expected this quarter
- Enrollment continues in Phase 1b dose-finding trial of miricorilant in patients
with presumed non-alcoholic steatohepatitis (NASH) – data expected in the first half of 2023
“We expect our double-blind, placebo-controlled GRATITUDE and GRATITUDE II trials in patients with AIWG to build on the positive data from our Phase 1 studies,” said
“The goal of our Phase 1b dose-finding study in patients with NASH is to identify a dosing regimen that captures the unprecedented rapidity and magnitude of liver fat reduction observed in our prior study without causing excessive liver irritation,” added
Cushing’s Syndrome
- Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected
in second half 2023 - Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients
with Cushing’s syndrome caused by adrenal adenomas
“We advanced relacorilant to Phase 3 in Cushing’s syndrome based on its extremely promising Phase 2 efficacy and safety data. We expect our GRACE trial to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the second half of 2023,” said
Conference Call
We will hold a conference call on
Hypercortisolism
Hypercortisolism, 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
About
Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol and owns extensive
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 such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business, conduct our clinical trials and achieve our other goals during the COVID-19 pandemic and generate sufficient revenue to fund our activities; the availability of competing treatments for hypercortisolism, including generic versions of Korlym; our ability to obtain acceptable prices and adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; the timing, cost and outcome of legal disputes and investigations; and the scope and protective power of our intellectual property. These and other risks are set forth in our
In this press release, forward-looking statements include, among others, those concerning our expectations regarding the course of the COVID-19 pandemic and its effects on our commercial results and clinical activities; the number of eligible patients who have yet to receive Korlym; our continued revenue growth and 2022 revenue guidance; cortisol modulation’s potential to treat many serious diseases; development of relacorilant as a treatment for Cushing’s syndrome and ovarian, adrenal and prostate cancer, including relacorilant’s clinical attributes, regulatory approvals, mandates and oversight, and other requirements; the potential for relacorilant plus nab-paclitaxel to become a standard of care for patients with recurrent platinum-resistant ovarian cancer; the timing and substance of our results in the GRATITUDE trials of miricorilant in patients with antipsychotic-induced weight gain and our Phase 1b trial in patients with NASH; expectations regarding the GRACE trial as the basis for relacorilant’s NDA in Cushing’s syndrome; the timing and expectations of our DAZALS trial of dazucorilant in patients with ALS; our other pre-clinical and clinical development programs, including the pace of enrollment, study design and timelines, and the accrual and attributes of clinical data; and the timing of regulatory submissions. We disclaim any intention or duty to update forward-looking statements made in this press release.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
2022 |
2021(1) |
||
(Unaudited) | |||
Assets | |||
Cash and investments | $ 401,157 | $ 335,812 | |
Trade receivables, net of allowances | 29,414 | 27,625 | |
Inventory | 17,073 | 17,950 | |
Operating lease right-of-use asset | 1,707 | 514 | |
Deferred tax assets, net | 57,342 | 27,455 | |
Other assets | 26,562 | 14,400 | |
Total assets | $ 533,255 | $ 423,756 | |
Liabilities and Stockholders’ Equity | |||
Accounts payable | $ 8,178 | $ 6,908 | |
Operating lease liabilities | 1,707 | 526 | |
Other liabilities | 50,006 | 40,516 | |
Stockholders’ equity | 473,364 | 375,806 | |
Total liabilities and stockholders’ equity | $ 533,255 | $ 423,756 | |
(1) Derived from audited financial statements at that date |
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
(In thousands, except per share data)
Three Months Ended | Nine Months Ended | ||||||
2022 | 2021 | 2022 | 2021 | ||||
Revenues | |||||||
Product revenue, net | $ 101,728 | $ 96,131 | $ 298,802 | $ 267,156 | |||
Operating expenses | |||||||
Cost of sales | 1,339 | 1,275 | 3,905 | 3,927 | |||
Research and development | 33,292 | 28,091 | 94,237 | 85,345 | |||
Selling, general and administrative | 35,163 | 30,533 | 110,525 | 90,071 | |||
Total operating expenses | $ 69,794 | $ 59,899 | $ 208,667 | $ 179,343 | |||
Income from operations | 31,934 | 36,232 | 90,135 | 87,813 | |||
Interest and other income | 1,070 | 72 | 1,780 | 457 | |||
Income before income taxes | 33,004 | 36,304 | 91,915 | 88,270 | |||
Income tax benefit (expense) | 1,604 | (5,833) | (7,098) | (7,811) | |||
Net income | $ 34,608 | $ 30,471 | $ 84,817 | $ 80,459 | |||
Net income attributable to common stockholders | $ 34,550 | $ 30,471 | $ 84,755 | $ 80,459 | |||
Basic net income per common share | $ 0.32 | $ 0.26 | $ 0.80 | $ 0.69 | |||
Diluted net income per common share | $ 0.30 | $ 0.24 | $ 0.73 | $ 0.63 | |||
Weighted-average shares outstanding used in computing net income per common share | |||||||
Basic | 107,125 | 115,791 | 106,479 | 116,297 | |||
Diluted | 116,620 | 125,136 | 115,818 | 127,173 |
CONTACT:
Investor Relations
ir@corcept.com
www.corcept.com
Source: Corcept Therapeutics Incorporated