UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
FORM 8-K CURRENT REPORT
Pursuant to Section 13 or 15(d) of the |
Date of Report: March 05, 2014
(Date of earliest event reported)
Corcept Therapeutics
(Exact name of registrant as specified in its charter)
DE
(State or other jurisdiction
of incorporation)
000-50679
(Commission File Number)
77-0487658
(IRS Employer
Identification Number)
149 Commonwealth, Menlo Park CA
(Address of principal executive offices)
94025
(Zip Code)
(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:
- o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
- o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
- o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
- o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
- o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
Item 2.02. Results of Operations and Financial Condition On March 5, 2014, Corcept Therapeutics Incorporated (the "Company"), issued a press release announcing its financial results for the quarter and year ended December 31, 2013. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The information in this Item 2.02 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 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 7.01. Regulation FD Disclosure
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
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.
|
|
Dated: March 05, 2014 |
CORCEPT THERAPEUTICS
By: /s/ G. Charles Robb |
|
|
|
| Exhibit No. | Description |
| 99.1 | Press Release of Corcept Therapeutics dated March 05, 2014 |
MENLO PARK, CA -- (Marketwired - March 05, 2014) - Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, psychiatric and oncologic disorders, today reported its financial results for the fourth quarter and full year ended December 31, 2013.
For the fourth quarter of 2013, Corcept recognized $4.1 million in net product revenue compared to $1.4 million for the same period in 2012, after deducting associated government rebates, chargebacks and other allowances. For the full year 2013, Corcept reported net product revenue of $10.4 million compared to $3.3 million in the comparable period in 2012. Cost of sales for the fourth quarter of 2013 and the full year 2013 were $60,000 and $143,000, respectively, compared to $19,000 and $91,000 for the comparable periods in 2012. Cost of sales includes the cost to manufacture Korlym (which includes material, third-party manufacturing costs and indirect personnel and other overhead costs) based on units sold in the current period, as well as the cost of stability testing and distribution.
Corcept reported a net loss of $11.1 million, or $0.11 per share, for the fourth quarter of 2013, compared to a net loss of $11.1 million, or $0.11 per share for the same period in 2012. For the fiscal year ended December 31, 2013, Corcept reported a net loss of $46.0 million, or $0.46 per share, compared to a net loss of $38.0 million, or $0.41 per share for the full year 2012.
The net loss for the fourth quarter of 2013 included significant non-cash expenses of $2.4 million, compared to $2.2 million for the fourth quarter of 2012. For the full year 2013, the net loss included significant non-cash expenses of $9.6 million, as compared to $7.0 million for the full year of 2012. After adjusting for these non-cash expenses, the company's net loss on a non-GAAP basis was $8.7 million, or $0.09 per share, for the fourth quarter of 2013, compared to $9.0 million, or $0.09 per share, for the same period in 2012. For the fiscal year ended December 31, 2013, the non-GAAP net loss was $36.4 million, or $0.36 per share, compared to $31.1 million, or $0.33 per share, for the full year 2012. A reconciliation from U.S. GAAP net loss to non-GAAP net loss is included in this press release.
Corcept's cash balance as of December 31, 2013 was $54.9 million, as compared to $93.0 million at December 31, 2012. During the year, we spent $37.1 million on operating activities and issued payments of $1.0 million related to our capped royalty financing obligation.
Operating expenses for the fourth quarter were $14.1 million, compared to $11.4 million for the fourth quarter of 2012. Operating expenses for the full year 2013 were $51.9 million, compared to $39.6 million for the same period in 2012.
- Selling, general and administrative (SG&A) expenses in the fourth quarter of 2013 were $7.5 million, compared to $6.5 million for the comparable period in 2012. SG&A expenses were $31.2 million for the full year 2013, compared to $25.4 million for the same period in 2012. The increases in both the fourth quarter and full year were primarily due to increased staffing, expansion of our contracted sales force, consultancy and other professional services costs related to the commercialization of Korlym®.
- Research and development (R&D) expenses in the fourth quarter of 2013 were $6.6 million, compared to $4.9 million for the comparable period in 2012. R&D expenses were $20.5 million for the full year 2013, compared to $14.1 million for the same period in 2012. The increase was primarily due to accelerated patient enrollment in the third and fourth quarters in our Phase 3 study of mifepristone for the treatment of psychotic depression, which was only partially offset by decreases in costs for the clinical trials with Korlym for Cushing's syndrome, drug-drug interaction and other NDA-supportive studies.
Significant non-cash expenses included stock-based compensation of $1.3 million and $5.2 million for the fourth quarter and full year of 2013, respectively, as compared to $1.0 million and $5.3 million, respectively for the comparable periods of 2012. The full year 2012 stock-based compensation expense included $1.3 million related to performance-based stock options that vested in their entirety on the approval by the FDA of our New Drug Application for Korlym in February 2012. In addition, the net loss for the fourth quarter and full year of 2013 included $1.1 million and $4.4 million, respectively, attributable to accretion of interest expense on Corcept's capped royalty financing obligation, which we entered into in August 2012. We recorded $1.1 million and $1.7 million, respectively, of accretion of interest expense on our capped royalty transaction for the fourth quarter and full year of 2012.
About Cushing's Syndrome
Endogenous Cushing's syndrome is caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing's syndrome is an orphan indication that most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients annually in the United States. An estimated 20,000 patients in the United States have Cushing's syndrome. Symptoms vary, but most people have 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. Cushing's syndrome can affect every organ system in the body and can be lethal if not treated effectively.
About Korlym®
Korlym blocks the glucocorticoid receptor type II (GR-II) to which cortisol normally binds, thereby inhibiting the effects of excess cortisol in Cushing's syndrome patients. On April 10, 2012, Corcept made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing's syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness and the FDA has designated it as an Orphan Drug for that indication. Orphan Drug designation is a special status designed to encourage the development of medicines for rare diseases and conditions. Because Korlym is an Orphan Drug, Corcept will have marketing exclusivity for the approved indication in the United States until February 2019.
About Psychotic Depression
Psychotic depression is a serious psychiatric disorder that affects approximately three million people annually in the United States. It is more prevalent than either schizophrenia or bipolar I disorder. The disorder is characterized by severe depression accompanied by delusions, hallucinations or both. People with psychotic depression are approximately 70 times more likely to commit suicide than the general population and often require lengthy and expensive hospital stays. There is no FDA-approved treatment for psychotic depression.
About Triple-Negative Breast Cancer
Triple-negative breast cancer is a form of the disease in which the three receptors that fuel most breast cancer growth -- estrogen, progesterone, and the HER-2/neu gene -- are not present. Since the tumor cells lack the necessary receptors, common treatments, such as hormone therapy and drugs that target estrogen, progesterone, and HER-2, are ineffective. In 2013, approximately 40,000 women were diagnosed with triple-negative breast cancer in the United States. There is no FDA approved treatment and no accepted standard of care for these patients.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, psychiatric and oncologic disorders. The FDA has approved the company's first drug, Korlym® (mifepristone) 300 mg Tablets, a glucocorticoid receptor antagonist, as a once-daily oral treatment for hyperglycemia secondary to endogenous Cushing's syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. The company also has a Phase 3 trial underway for mifepristone for treatment of psychotic depression and a portfolio of selective GR antagonists that block the effects of cortisol but not progesterone. It owns extensive intellectual property covering the use of GR antagonists, including mifepristone, in the treatment of a wide variety of metabolic and psychiatric disorders and in triple-negative breast cancer. It also holds composition of matter patents for its selective GR antagonists.
Non-GAAP Measures of Net Loss
To supplement Corcept's financial results presented on a GAAP basis, we use non-GAAP measures of net loss that exclude significant non-cash expenses related to stock-based compensation expense and the accretion of interest expense under our capped royalty financing transaction. We believe that this non-GAAP measure of net loss helps investors better evaluate the company's past financial performance and potential future results. Non-GAAP measures should not be considered in isolation or as a substitute for comparable GAAP accounting and investors should read them in conjunction with the company's financial statements prepared in accordance with GAAP. The non-GAAP measure of net loss we use may be different from, and not directly comparable to, similarly titled measures used by other companies.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
Statements made in this news release, other than statements of historical fact, are forward-looking statements. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements, including the pace of Korlym's acceptance by physicians and patients, the pace of enrollment in or the outcome of the company's phase 3 trial of mifepristone for the treatment of psychotic depression, the effects of rapid technological change and competition, the protections afforded by Korlym's Orphan Drug Designation or by Corcept's other intellectual property rights, or the cost, pace and success of Corcept's product development efforts, including its ability to advance its next-generation GR-II antagonists towards human use. These and other risks are set forth in the company's SEC filings, all of which are available from the company's website (http://www.corcept.com) or from the SEC's website (http://www.sec.gov). Corcept disclaims any intention or duty to update any forward-looking statement made in this news release.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED BALANCE SHEETS
(in thousands)
December 31, December 31,
2013 2012
------------- -------------
(Unaudited) (Note)
ASSETS:
Cash and cash equivalents $ 54,877 $ 93,032
Trade receivables, net 1,428 557
Inventory 5,546 4,663
Other assets 1,226 914
------------- -------------
Total assets $ 63,077 $ 99,166
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Accounts payable $ 2,381 $ 3,804
Deferred revenue 25 16
Long-term obligation 35,065 31,680
Other liabilities 4,589 1,889
Stockholders' equity 21,017 61,777
------------- -------------
Total liabilities and stockholders' equity $ 63,077 $ 99,166
============= =============
Note: Derived from audited financial statements at that date.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Year Ended
December 31, December 31,
-------------------- --------------------
2013 2012 2013 2012
--------- --------- --------- ---------
Revenues:
Product sales, net $ 4,115 $ 1,377 $ 10,357 $ 3,307
Operating expenses:
Cost of sales 60 19 143 91
Research and development 6,567 4,856 20,470 14,074
Selling, general and
administrative 7,517 6,482 31,240 25,414
--------- --------- --------- ---------
Total operating expenses 14,144 11,357 51,853 39,579
--------- --------- --------- ---------
Loss from operations (10,029) (9,980) (41,496) (36,272)
Interest and other income, net - - - -
Interest and other expense (1,095) (1,144) (4,515) (1,776)
--------- --------- --------- ---------
Net loss $ (11,124) $ (11,124) $ (46,011) $ (38,048)
========= ========= ========= =========
Basic and diluted net loss per
share $ (0.11) $ (0.11) $ (0.46) $ (0.41)
========= ========= ========= =========
Shares used in computing basic
and diluted net loss per share 99,833 99,796 99,819 93,015
========= ========= ========= =========
CORCEPT THERAPEUTICS INCORPORATED
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Year Ended
December 31, December 31,
-------------------- --------------------
2013 2012 2013 2012
--------- --------- --------- ---------
GAAP net loss $ (11,124) $ (11,124) $ (46,011) $ (38,048)
Significant non-cash expenses:
Stock-based compensation
Research and development 153 130 618 546
Selling, general and
administrative 1,160 916 4,578 4,764
--------- --------- --------- ---------
Total stock-based
compensation 1,313 1,046 5,196 5,310
--------- --------- --------- ---------
Accretion of interest expense
related to long-term
obligation 1,070 1,105 4,410 1,680
--------- --------- --------- ---------
Non-GAAP net loss $ (8,741) $ (8,973) $ (36,405) $ (31,058)
========= ========= ========= =========
GAAP basic and diluted net loss
per share $ (0.11) $ (0.11) $ (0.46) $ (0.41)
========= ========= ========= =========
Non-GAAP basic and diluted net
loss per share as adjusted for
significant non-cash expenses $ (0.09) $ (0.09) $ (0.36) $ (0.33)
========= ========= ========= =========
Shares used in computing basic
and diluted net loss per share 99,833 99,796 99,819 93,015
========= ========= ========= =========
CONTACT: Charles Robb Chief Financial Officer Corcept Therapeutics 650-688-8783 crobb@corcept.com www.corcept.com