Corcept Therapeutics Announces Fourth Quarter and Full-Year 2021 Audited Financial Results and Provides Corporate Update
Corcept Therapeutics Announces Fourth Quarter and Full-Year 2021 Audited Financial Results and Provides Corporate Update
February 15, 2022 at 4:05 PM EST
Financial Results
- Fourth quarter revenue of
$98.8 million , compared to$85.7 million in fourth quarter 2020 - 2021 revenue of
$366.0 million , compared to$353.9 million in 2020 - 2022 revenue guidance of
$400 –$430 million - Fourth quarter GAAP net income of
$32.1 million , compared to$26.0 million in fourth quarter 2020 - 2021 GAAP net income of
$112.5 million , compared to$106.0 million in 2020 - Purchase of ten million shares of Corcept common stock for
$207.5 million in fourth quarter 2021 - Cash and investments of
$335.8 million
“Korlym is an excellent treatment for Cushing’s syndrome and there are many eligible patients who have yet to receive it. As pandemic restrictions and fears recede, as they already have in certain locations, we expect our growth to continue and are providing 2022 revenue guidance of
Corcept’s fourth quarter 2021 revenue was
GAAP net income was
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 fourth quarter was
Cash and investments of
Clinical Development
“In addition to successfully managing challenges posed by the pandemic for our commercial business, we significantly advanced our clinical development programs in 2021,” said
Solid Tumors
- Updated overall survival data from Phase 2 trial in patients with recurrent platinum-resistant ovarian cancer expected in first quarter 2022; Phase 3 trial planned to start second quarter 2022
- Selection of the optimum dose of exicorilant or relacorilant plus enzalutamide in patients with castration-resistant prostate cancer (CRPC) expected in second quarter 2022
- Enrollment continues in 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
“Our 178-patient, randomized, controlled Phase 2 trial of relacorilant in patients with recurrent platinum-resistant ovarian cancer met its objective of improving progression free survival, without increased side effect burden,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We and our investigators are excited to advance relacorilant for the potential treatment of ovarian cancer based on these statistically significant and clinically meaningful results. We expect the trial’s updated overall survival data later this quarter and plan to meet with the FDA in the coming months to define the best path forward.”
Metabolic Diseases
- Enrollment completed in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing antipsychotic-induced weight gain (AIWG); data expected in fourth quarter 2022
- Completion of enrollment in GRATITUDE, a double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse recent AIWG, expected by mid-2022; data expected in fourth quarter 2022
- Enrollment continues in Phase 1b dose-finding trial of miricorilant in patients with presumed NASH
“We are pleased to have fully-enrolled GRATITUDE II and to be nearing completion of enrollment in GRATITUDE. AIWG is a serious metabolic disorder suffered by millions of patients in
“We and our investigators are very excited by the unprecedented rapidity and magnitude of liver fat reduction experienced by patients taking miricorilant in our previous NASH study,” 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 quarter 2023
- Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
“Our Phase 3 GRACE and GRADIENT trials continue to accrue patients and generate data. We expect GRACE to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, and we are on track to make this submission in the second quarter 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
GAAP Measures of Net Income
To supplement our financial results presented on a GAAP basis, we use a non-GAAP measure 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) the use of deferred tax assets to offset current tax expense and (iii) related income tax effects. We believe this non-GAAP measure helps investors evaluate our financial performance and potential future results. Our non-GAAP measure may be different from, and not directly comparable to, those used by other companies. It is 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 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 those concerning our expectations regarding the course of the COVID-19 pandemic and its effects on our commercial results and clinical activities as pandemic restrictions and fears intensify or recede; the number of eligible patients who have yet to receive Korlym; our 2022 revenue guidance; cortisol modulation’s potential to treat many serious diseases; the advancement of our new cortisol modulators to the clinic; planned meetings with the
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
2021(1) |
2020(1) |
||||||
| Assets | |||||||
| Cash and investments | $ | 335,812 | $ | 476,892 | |||
| Trade receivables, net of allowances | 27,625 | 26,198 | |||||
| Inventory | 17,950 | 21,157 | |||||
| Operating lease right-of-use asset | 514 | 2,509 | |||||
| Deferred tax assets, net | 27,455 | 31,603 | |||||
| Other assets | 14,400 | 13,372 | |||||
| Total assets | $ | 423,756 | $ | 571,731 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Accounts payable | $ | 6,908 | $ | 10,554 | |||
| Operating lease liabilities | 526 | 2,551 | |||||
| Other liabilities | 40,516 | 35,288 | |||||
| Stockholders’ equity | 375,806 | 523,338 | |||||
| Total liabilities and stockholders’ equity | $ | 423,756 | $ | 571,731 | |||
| (1) Derived from audited financial statements at that date | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands, except per share data)
| Three Months Ended | Year Ended | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||
| Revenues | |||||||||||||||||||
| Product revenue, net | $ | 98,822 | $ | 85,735 | $ | 365,978 | $ | 353,874 | |||||||||||
| Operating expenses | |||||||||||||||||||
| Cost of sales | 1,354 | 1,254 | 5,281 | 5,582 | |||||||||||||||
| Research and development | 28,519 | 28,275 | 113,864 | 114,764 | |||||||||||||||
| Selling, general and administrative | 32,285 | 25,696 | 122,356 | 105,326 | |||||||||||||||
| Total operating expenses | $ | 62,158 | $ | 55,225 | $ | 241,501 | $ | 225,672 | |||||||||||
| Income from operations | 36,664 | 30,510 | 124,477 | 128,202 | |||||||||||||||
| Interest and other income | 72 | 297 | 529 | 3,400 | |||||||||||||||
| Income before income taxes | 36,736 | 30,807 | 125,006 | 131,602 | |||||||||||||||
| Income tax expense | (4,683 | ) | (4,813 | ) | (12,494 | ) | (25,591 | ) | |||||||||||
| Net income | $ | 32,053 | $ | 25,994 | $ | 112,512 | $ | 106,011 | |||||||||||
| Other comprehensive income: | |||||||||||||||||||
| Net unrealized loss on available-for-sale investments, net of tax impact of |
(356 | ) | (309 | ) | (621 | ) | (50 | ) | |||||||||||
| Foreign currency translation gain (loss), net of tax | 14 | 147 | (21 | ) | 204 | ||||||||||||||
| Total comprehensive income | $ | 31,711 | $ | 25,832 | $ | 111,870 | $ | 106,165 | |||||||||||
| Basic net income per share | $ | 0.28 | $ | 0.22 | $ | 0.97 | $ | 0.92 | |||||||||||
| Diluted net income per share | $ | 0.26 | $ | 0.20 | $ | 0.89 | $ | 0.85 | |||||||||||
| Shares used in computing basic net income per common share | 113,741 | 116,320 | 115,653 | 115,412 | |||||||||||||||
| Shares used in computing diluted net income per common share | 122,432 | 127,423 | 125,963 | 124,194 | |||||||||||||||
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME
(In thousands, except per share data)
| Three Months Ended | Year Ended | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||
| GAAP net income | $ | 32,053 | $ | 25,994 | $ | 112,512 | $ | 106,011 | |||||||||||
| Non-cash expenses (benefits) | |||||||||||||||||||
| Stock-based compensation | |||||||||||||||||||
| Cost of sales | 21 | 15 | 59 | 66 | |||||||||||||||
| Research and development | 3,342 | 2,865 | 14,106 | 11,222 | |||||||||||||||
| Selling, general and administrative | 7,447 | 5,550 | 28,766 | 22,251 | |||||||||||||||
| Total stock-based compensation | 10,810 | 8,430 | 42,931 | 33,539 | |||||||||||||||
| Deferred income taxes | 2,299 | 2,311 | 4,346 | 14,089 | |||||||||||||||
| Income tax effect of non-GAAP adjustments (1) | (2,594 | ) | (2,023 | ) | (10,303 | ) | (8,049 | ) | |||||||||||
| Non-GAAP net income, adjusted for non-cash expenses | $ | 42,568 | $ | 34,712 | $ | 149,486 | $ | 145,590 | |||||||||||
| GAAP basic net income per share | $ | 0.28 | $ | 0.22 | $ | 0.97 | $ | 0.92 | |||||||||||
| GAAP diluted net income per share | $ | 0.26 | $ | 0.20 | $ | 0.89 | $ | 0.85 | |||||||||||
| Non-GAAP basic net income per share, adjusted for non-cash expenses per share | $ | 0.37 | $ | 0.30 | $ | 1.29 | $ | 1.26 | |||||||||||
| Non-GAAP diluted net income per share, adjusted for non-cash expenses per share | $ | 0.35 | $ | 0.27 | $ | 1.19 | $ | 1.17 | |||||||||||
| Shares used in computing basic net income per common share | 113,741 | 116,320 | 115,653 | 115,412 | |||||||||||||||
| Shares used in computing diluted net income per common share | 122,432 | 127,423 | 125,963 | 124,194 | |||||||||||||||
| (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments. | |||||||||||||||||||
CONTACT:
Investor Relations
ir@corcept.com
www.corcept.com
Source: Corcept Therapeutics Incorporated