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 06, 2017
(Date
of earliest event reported)
Corcept Therapeutics
(Exact name of
registrant as specified in its charter)
CA
(State or
other jurisdiction
of incorporation) 000-50679
(Commission
File Number) 74-0487658
(IRS Employer
Identification Number)
149 Commonwealth Drive
(Address of
principal executive offices)
94025
(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:
- 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 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 06, 2017 |
CORCEPT THERAPEUTICS
By: /s/ Charles Robb
|
|
| |
| Exhibit No. | Description |
| 99.1 | Press Release of Corcept Therapeutics dated March 06, 2017 |
MENLO PARK, CA -- (Marketwired - March 06, 2017) - Corcept Therapeutics Incorporated (NASDAQ: CORT)
- 2016 revenue of $81.3 million, a 62 percent increase from 2015
- Fourth quarter 2016 revenue of $23.8 million, a 59 percent increase from fourth quarter 2015
- 2016 GAAP net income of $8.1 million, compared to GAAP net loss of $6.4 million in 2015
- Fourth quarter GAAP net income of $4.6 million, compared to $1.0 million in fourth quarter 2015
- 2016 non-GAAP net income of $17.1 million, compared to $2.5 million in 2015
- Fourth quarter non-GAAP net income of $6.9 million, compared to $3.1 million in fourth quarter 2015
- 2017 revenue guidance increased to $120 - $130 million
Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today reported financial results for the quarter- and year-ended December 31, 2016.
The company also increased its 2017 revenue guidance from $115 - $125 million to $120 - $130 million.
"Our Cushing's syndrome franchise performed well in 2016 and we are pleased with its strong start this year," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "The clinical specialists we hired in the middle of 2016 have become full contributors to our sales effort. Another cohort of clinical specialists has just completed its training. We look forward to their contributions later this year. Our highly-skilled field personnel continue to introduce new physicians to Korlym®, while experienced prescribers continue to identify additional patients who may benefit from the medication. Our growing revenues will fully-fund our planned clinical programs (Korlym, CORT125134, CORT125281 and CORT118335), our discovery and pre-clinical development work and the development of our FKBP5 gene expression assay -- a prospective new tool to help diagnose and treat patients with Cushing's syndrome."
Financial Discussion
Corcept reported revenue of $23.8 million for
the fourth quarter of 2016 and $81.3 million for the full year. GAAP net income
for the fourth quarter of 2016 was $4.6 million, or $0.04 per share, compared to
net income of $1.0 million, or $0.01 per share, in the fourth quarter of 2015.
For the full year, the company reported GAAP net income of $8.1 million, or
$0.07 per share, compared to a net loss of $6.4 million, or $0.06 per share, in
2015.
Excluding non-cash expenses related to stock-based compensation and implied interest on the company's capped royalty obligation (the "Royalty Financing"), Corcept reported $6.9 million of non-GAAP net income in the fourth quarter, compared to non-GAAP net income of $3.1 million in the fourth quarter of 2015. Non-GAAP net income for 2016 was $17.1 million, compared to non-GAAP net income of $2.5 million for 2015. A reconciliation of GAAP to non-GAAP net operating results is set forth below.
Operating expenses in the fourth quarter of 2016 were $18.8 million, compared to $13.3 million in the fourth quarter of 2015. Full-year operating expenses were $71.1 million, compared to $53.7 million in 2015. These increases were primarily due to (i) greater compensation expense for the company's expanded sales force and operational costs resulting from increased sales volumes and (ii) increased spending on development of CORT125134 and other selective cortisol modulators.
Corcept's cash and cash equivalents were $51.5 million at December 31, 2016, an increase of $3.7 million from September 30, 2016 and $11.1 million from December 31, 2015. The company's cash balances reflect scheduled payments under the Royalty Financing of $4.4 million in the fourth quarter of 2016 and $14.8 million for all of 2016. Corcept expects to make its final payment under the Royalty Financing in July 2017.
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 20-50. An estimated
10-15 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 modulates the effect of cortisol at
the glucocorticoid receptor, one of the two receptors to which cortisol binds,
thereby inhibiting the effects of excess cortisol in patients with Cushing's
syndrome. Since 2012, Corcept has 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. The FDA has designated it as an Orphan Drug for that
indication.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical
company engaged in the discovery, development and commercialization of drugs
that treat severe metabolic, oncologic and psychiatric disorders by modulating
the effects of cortisol. Korlym, a first-generation cortisol modulator, is the
company's first FDA-approved medication. The company has a portfolio of
proprietary compounds that modulate the effects of cortisol but not
progesterone. Corcept owns extensive intellectual property covering the use of
cortisol modulators, including mifepristone, in the treatment of a wide variety
of metabolic, oncologic and psychiatric disorders. It also holds composition of
matter patents covering its selective cortisol modulators.
Forward-Looking Statements
Statements made in this news release,
other than statements of historical fact, are forward-looking statements. These
forward-looking statements, including statements regarding anticipated future
revenues, the timing of clinical trials and clinical trial results and expansion
of the company's clinical and pre-clinical pipeline are subject to known and
unknown risks and uncertainties that might cause actual results to differ
materially from those expressed or implied by such statements. Such risks and
uncertainties include the pace of Korlym's acceptance by physicians and
patients, the cost, pace of enrollment in and the outcome of the planned trials
of CORT125134, CORT118335 and CORT125281, development of an assay of FKBP5 gene
expression, the protections afforded by Korlym's Orphan Drug designation and
Corcept's other intellectual property rights. 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,
2016 2015
------------- -------------
ASSETS:
Cash and cash equivalents $ 51,536 $ 40,435
Trade receivables, net 9,860 6,221
Inventory 5,164 4,482
Other assets 2,193 764
------------- -------------
Total assets $ 68,753 $ 51,902
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Accounts payable $ 2,290 $ 1,325
Deferred revenue - 158
Long-term obligation 14,664 27,493
Other liabilities 10,420 4,428
Stockholders' equity (deficit) 41,379 18,498
------------- -------------
Total liabilities and stockholders' equity $ 68,753 $ 51,902
============= =============
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three Months Ended Year Ended
December 31, December 31,
-------------------- --------------------
2016 2015 2016 2015
--------- --------- --------- ---------
Revenues:
Product sales, net $ 23,811 $ 14,967 $ 81,321 $ 50,286
Operating expenses:
Cost of sales 561 364 2,058 1,361
Research and development 6,484 4,089 23,844 15,419
Selling, general and
administrative 11,760 8,863 45,240 36,949
--------- --------- --------- ---------
Total operating expenses 18,805 13,316 71,142 53,729
--------- --------- --------- ---------
Income / (Loss) from operations 5,007 1,651 10,179 (3,443)
Interest and other expense (410) (692) (2,039) (2,965)
--------- --------- --------- ---------
Net income / (loss) $ 4,597 $ 959 $ 8,140 $ (6,408)
========= ========= ========= =========
Basic and diluted net income /
(loss) per share $ 0.04 $ 0.01 $ 0.07 $ (0.06)
========= ========= ========= =========
Shares used in computing basic
net income / (loss) per share 111,902 109,191 110,566 106,883
========= ========= ========= =========
Shares used in computing diluted
net income / (loss) per share 118,866 113,783 116,139 106,883
========= ========= ========= =========
CORCEPT THERAPEUTICS INCORPORATED
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS
(in thousands, except per share amounts)
Three Months Ended Year Ended
December 31, December 31,
------------------- -------------------
2016 2015 2016 2015
--------- --------- --------- ---------
GAAP net income / (loss) $ 4,597 $ 959 $ 8,140 $ (6,408)
Non-cash expenses:
Stock-based compensation
Research and development 433 260 1,312 839
Selling, general and
administrative 1,525 1,233 5,747 5,174
--------- --------- --------- ---------
Total stock-based
compensation 1,958 1,493 7,059 6,013
--------- --------- --------- ---------
Accretion of interest expense
related to long-term obligation 367 651 1,929 2,848
--------- --------- --------- ---------
Non-GAAP net income / (loss) $ 6,922 $ 3,103 $ 17,128 $ 2,453
========= ========= ========= =========
GAAP basic and diluted net income /
(loss) per share $ 0.04 $ 0.01 $ 0.07 $ (0.06)
========= ========= ========= =========
Non-GAAP basic and diluted net
income / (loss) per share as
adjusted for non-cash expenses $ 0.06 $ 0.03 $ 0.15 $ 0.02
========= ========= ========= =========
Shares used in computing basic net
income / (loss) per share 111,902 109,191 110,566 106,883
========= ========= ========= =========
Shares used in computing diluted
net income / (loss) per share 118,866 113,783 116,139 112,034
========= ========= ========= =========
CONTACT: Charles Robb Chief Financial Officer Corcept Therapeutics 650-688-8783 crobb@corcept.com www.corcept.com