UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | |||||||||
(Address of Principal Executive Offices) (Zip Code)
(650 ) 327-3270
Registrant's telephone number, including area code
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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Item 2.02. Results of Operations and Financial Condition.
Item 7.01 Regulation FD Disclosure.
On February 23, 2021, Corcept Therapeutics Incorporated (the “Company”) issued a press release announcing its financial results for the quarter ended December 31, 2020 and a corporate update. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Item 2.02 and Item 7.01 and the information contained in the press release attached as Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Item 2.02 and Item 7.01 and the information contained in the press release attached as Exhibit 99.1 is not incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in the filing unless specifically stated so therein.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
| Exhibits No. | Description | ||||
| 99.1 | |||||
| 104.1 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document. | ||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CORCEPT THERAPEUTICS INCORPORATED | ||||||||||||||
| Date: | February 23, 2021 | By: | /s/ Charles Robb | |||||||||||
| Name: Charles Robb | ||||||||||||||
| Title: Chief Financial Officer and Secretary | ||||||||||||||
EXHIBIT 99.1
CORCEPT THERAPEUTICS ANNOUNCES FOURTH QUARTER
AND FULL-YEAR 2020 AUDITED FINANCIAL RESULTS
•2020 revenue of $353.9 million, compared to $306.5 million in 2019
•Fourth quarter revenue of $85.7 million, compared to $87.9 million in 2019
•2020 GAAP net income of $106.0 million, compared to $94.2 million in 2019
•Fourth quarter GAAP net income of $26.0 million, compared to $29.4 million in fourth quarter 2019
•Cash and investments of $476.9 million at year-end, compared to $315.3 million at year-end 2019
•Acquisition of 458,769 shares pursuant to the company’s stock repurchase program
•Reiterated 2021 revenue guidance of $375 - 405 million
MENLO PARK, Calif. (February 23, 2021) - 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 hormone cortisol, today reported its results for the quarter- and year-ended December 31, 2020.
Corcept’s 2020 revenue was $353.9 million, compared to $306.5 million in 2019. Fourth quarter revenue was $85.7 million, compared to $87.9 million in the fourth quarter of 2019. The company reiterated its 2021 revenue guidance of $375 – 405 million.
GAAP net income was $106.0 million for the year and $26.0 million in the fourth quarter of 2020, compared to $94.2 million for the year and $29.4 million in the fourth quarter of 2019.
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 was $34.7 million in the fourth quarter, compared to $40.3 million in the fourth quarter of 2019. For the full-year, non-GAAP net income was $145.6 million, compared to $133.3 million in 2019. A reconciliation of GAAP to non-GAAP net income is included below.
Cash and investments increased by $32.7 million in the fourth quarter, to $476.9 million at December 31, 2020. At December 31, 2019, the balance of cash and investments was $315.3 million.
The company spent $9.7 million in the fourth quarter repurchasing 458,769 shares of common stock pursuant to its stock repurchase program. Under the currently authorized terms of that program, $190.3 million remains available for the repurchase of shares.
“Corcept’s financial and clinical accomplishments in 2020 lay the foundation for significant progress this year,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “As the COVID-19 pandemic is brought under control, the easing of public health restrictions and greater willingness of patients to visit their doctors will allow more physicians to diagnose and optimally treat patients with Cushing’s syndrome. We expect revenue next year of $375-405 million.
“Improving conditions should also permit more rapid progress in our clinical development programs, many of which have been significantly slowed by the pandemic,” he added. We are currently evaluating our proprietary, selective cortisol modulators as potential treatments for patients with metastatic ovarian and pancreatic cancer, castration-resistant prostate cancer, adrenal cancer, Cushing’s syndrome, antipsychotic-induced weight gain and non-alcoholic steatohepatitis. We will have topline data from our ovarian and pancreatic cancer trials in the second quarter. In the fourth quarter, we plan to initiate a Phase 2 trial in patients with amyotrophic lateral sclerosis (ALS).”
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. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its 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, the completion of our financial closing procedures and any adjustments that may result from the completion of the annual independent audit of our consolidated financial statements; our ability to operate our business and achieve our goals and conduct our clinical trials 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; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. 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 2021 revenue guidance and our stock repurchase program; the progress, enrollment, timing, design and results of our clinical trials; the course of the COVID-19 pandemic and its impact on patients, physicians, medical practice and clinical research activities; and the clinical and commercial attributes of Korlym, relacorilant, exicorilant and miricorilant and other proprietary, selective cortisol modulators. We disclaim any intention or duty to update forward-looking statements made in this press release.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
December 31, 2020 (1) | December 31, 2019 (1) | ||||||||||
| Assets | |||||||||||
| Cash and investments | $ | 476,892 | $ | 315,314 | |||||||
| Trade receivables, net of allowances | 26,198 | 19,928 | |||||||||
| Inventory | 21,157 | 17,405 | |||||||||
| Operating lease right-of-use asset | 2,509 | 3,446 | |||||||||
| Deferred tax assets, net | 31,603 | 45,677 | |||||||||
| Other assets | 13,372 | 10,542 | |||||||||
| Total assets | $ | 571,731 | $ | 412,312 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Accounts payable | $ | 10,554 | $ | 7,537 | |||||||
| Operating lease liabilities | 2,551 | 3,461 | |||||||||
| Other liabilities | 35,288 | 30,132 | |||||||||
Stockholders’ equity | 523,338 | 371,182 | |||||||||
| Total liabilities and stockholders’ equity | $ | 571,731 | $ | 412,312 | |||||||
(1) Derived from audited financial statements at that date | |||||||||||
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands, except per share data)
| Three Months Ended | Year Ended | ||||||||||||||||||||||
| December 31, | December 31, | ||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||
| Revenues | |||||||||||||||||||||||
| Product revenue, net | $ | 85,735 | $ | 87,895 | $ | 353,874 | $ | 306,486 | |||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Cost of sales | 1,254 | 1,436 | 5,582 | 5,504 | |||||||||||||||||||
| Research and development | 28,275 | 24,312 | 114,764 | 89,017 | |||||||||||||||||||
| Selling, general and administrative | 25,696 | 27,131 | 105,326 | 100,359 | |||||||||||||||||||
| Total operating expenses | $ | 55,225 | $ | 52,879 | $ | 225,672 | $ | 194,880 | |||||||||||||||
| Income from operations | 30,510 | 35,016 | 128,202 | 111,606 | |||||||||||||||||||
| Interest and other income | 297 | 1,444 | 3,400 | 5,070 | |||||||||||||||||||
| Income before income taxes | 30,807 | 36,460 | 131,602 | 116,676 | |||||||||||||||||||
| Income tax expense | (4,813) | (7,079) | (25,591) | (22,495) | |||||||||||||||||||
| Net income | $ | 25,994 | $ | 29,381 | $ | 106,011 | $ | 94,181 | |||||||||||||||
| Other comprehensive income (loss): | |||||||||||||||||||||||
Net unrealized gain on available-for-sale investments, net of tax impact of $96, $20, $15 and $(104), respectively | (309) | (62) | (50) | 327 | |||||||||||||||||||
| Foreign currency translation loss, net of tax | 147 | 9 | 204 | 4 | |||||||||||||||||||
| Total comprehensive income | $ | 25,832 | $ | 29,328 | $ | 106,165 | $ | 94,512 | |||||||||||||||
| Basic net income per share | $ | 0.22 | $ | 0.26 | $ | 0.92 | $ | 0.82 | |||||||||||||||
| Diluted net income per share | $ | 0.20 | $ | 0.24 | $ | 0.85 | $ | 0.77 | |||||||||||||||
| Shares used in computing basic net income per common share | 116,320 | 114,347 | 115,412 | 114,349 | |||||||||||||||||||
| Shares used in computing diluted net income per common share | 127,423 | 122,688 | 124,194 | 122,566 | |||||||||||||||||||
CORCEPT THERAPEUTICS INCORPORATED
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME
(In thousands, except per share data)
| Three Months Ended | Year Ended | ||||||||||||||||||||||
| December 31, | December 31, | ||||||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||
| GAAP net income | $ | 25,994 | $ | 29,381 | $ | 106,011 | $ | 94,181 | |||||||||||||||
| Non-cash expenses (benefits) | |||||||||||||||||||||||
| Stock-based compensation | |||||||||||||||||||||||
| Cost of sales | 15 | 39 | 66 | 144 | |||||||||||||||||||
| Research and development | 2,865 | 2,707 | 11,222 | 9,541 | |||||||||||||||||||
| Selling, general and administrative | 5,550 | 4,864 | 22,251 | 19,628 | |||||||||||||||||||
| Total stock-based compensation | 8,430 | 7,610 | 33,539 | 29,313 | |||||||||||||||||||
| Deferred income taxes | 2,311 | 5,146 | 14,089 | 16,877 | |||||||||||||||||||
Income tax effect of non-GAAP adjustments (1) | (2,023) | (1,826) | (8,049) | (7,035) | |||||||||||||||||||
| Non-GAAP net income, adjusted for non-cash expenses | $ | 34,712 | $ | 40,311 | $ | 145,590 | $ | 133,336 | |||||||||||||||
| GAAP basic net income per share | $ | 0.22 | $ | 0.26 | $ | 0.92 | $ | 0.82 | |||||||||||||||
| GAAP diluted net income per share | $ | 0.20 | $ | 0.24 | $ | 0.85 | $ | 0.77 | |||||||||||||||
| Non-GAAP basic net income per share, adjusted for non-cash expenses per share | $ | 0.30 | $ | 0.35 | $ | 1.26 | $ | 1.17 | |||||||||||||||
| Non-GAAP diluted net income per share, adjusted for non-cash expenses per share | $ | 0.27 | $ | 0.33 | $ | 1.17 | $ | 1.09 | |||||||||||||||
| Shares used in computing basic net income per common share | 116,320 | 114,347 | 115,412 | 114,349 | |||||||||||||||||||
| Shares used in computing diluted net income per common share | 127,423 | 122,688 | 124,194 | 122,566 | |||||||||||||||||||
(1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments. | |||||||||||||||||||||||
CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
cjames@corcept.com
www.corcept.com