Corcept Therapeutics Announces Fourth Quarter and Full Year 2012 Financial Results

Corcept Therapeutics Announces Fourth Quarter and Full Year 2012 Financial 
Results 
MENLO PARK, CA -- (Marketwire) -- 03/07/13 --  Corcept Therapeutics
Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the
discovery, development and commercialization of drugs for the
treatment of severe metabolic and psychiatric disorders, today
reported its financial results for the fourth quarter and full year
ended December 31, 2012. 
In April 2012, Corcept began offering its first product, Korlym(TM)
(mifepristone) 300 mg Tablets, as a once-daily oral treatment of
hyperglycemia secondary to endogenous Cushing's syndrome in adult
patients who have type 2 diabetes mellitus or glucose intolerance and
have failed surgery or are not candidates for surgery. 
For the fourth quarter of 2012, Corcept recognized $1.4 million in
net product revenue, after deducting associated government rebates,
chargebacks and other allowances. For the full year 2012, Corcept
reported net product revenue of $3.3 million. Cost of sales for the
fourth quarter of 2012 and the full year 2012 were $19,000 and
$91,000, respectively. Because we expensed product manufacturing
costs prior to FDA approval, our cost of sales consisted primarily of
stability testing and distribution costs. 
Corcept reported a net loss of $11.1 million, or $0.11 per share, for
the fourth quarter of 2012, compared to a net loss of $9.9 million,
or $0.12 per share for the same period in 2011. For the fiscal year
ended December 31, 2012, Corcept reported a net loss of $38.0
million, or $0.41 per share, compared to a net loss of $32.4 million,
or $0.39 per share, for the full year 2011. 
The net loss for the fourth quarter of 2012 included significant
non-cash expenses of $2.2 million, compared to $1.0 million for the
fourth quarter of 2011. For the full year 2012, the net loss included
significant non-cash expenses of $7.0 million, as compared to $3.4
million for the full year of 2011. After adjusting for these non-cash
expenses, the company's net loss on a non-GAAP basis was $9.0
million, or $0.09 per share, for the fourth quarter of 2012, compared
to $8.9 million, or $0.11 per share, for the same period in 2011. For
the fiscal year ended December 31, 2012, the non-GAAP net loss was
$31.1 million, or $0.33 per share, compared to $28.9 million, or
$0.35 per share, for the full year 2011. 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, 2012 was $93.0 million, as
compared to $39.6 million at December 31, 2011, and included net
proceeds of (i) $13.6 million from our March 2012 warrant exchange
and other warrant and option exercises, (ii) $46.1 million from our
July 2012 sale of common stock and (iii) $29.9 million from our
August 2012 capped royalty financing transaction, less $36.0 million
spent on operations during the year. 
Operating expenses for the fourth quarter were $11.4 million,
compared to $9.9 million for the fourth quarter of 2011. Operating
expenses for the full year 2012 were $39.6 million, compared to $32.3
million for the same period in 2011. 


 
--  Selling, general and administrative (SG&A) expenses in the fourth
    quarter of 2012 were $6.5 million, compared to $3.3 million for the
    comparable period in 2011. SG&A expenses were $25.4 million for
    the full year 2012, compared to $11.3 million for the same period in
    2011. The increases in both the fourth quarter and full year were
    primarily due to increased staffing, consultancy and other
    professional services costs related to the commercialization of
    Korlym.
    
    
--  Research and development (R&D) expenses in the fourth quarter of
    2012 were $4.9 million, compared to $6.6 million for the comparable
    period in 2011. The decrease was primarily due to a reduction in our
    product manufacturing expenses, which we began capitalizing as
    inventory following FDA approval. R&D expenses were $14.1 million
    for the full year 2012, compared to $21.0 million for the same period
    in 2011. The decrease was primarily due to (i) lower consultancy costs
    (ii) capitalization of product manufacturing costs as inventory after
    FDA approval and (iii) decreased clinical trial costs related to
    Cushing's syndrome. These decreases were partially offset by the cost
    of expanding our (i) phase 3 trial of mifepristone for the treatment
    of psychotic depression and (ii) discovery research for our
    next-generation selective GR-II antagonists.

  
Significant non-cash expenses included stock-based compensation of $1.0
million and $5.3 million for the fourth quarter and full year of
2012, respectively, as compared to $1.0 million and $3.4 million,
respectively for the comparable periods of 2011. 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 2012 included $1.1 million and $1.7 million,
respectively, attributable to accretion of interest expense on
Corcept's capped royalty financing transaction, which we entered into
in August 2012. 
In 2013, Corcept plans to focus on both the commercialization of
Korlym and the company's other strategic priorities -- enrolling a
sufficient number of patients in our phase 3 study of mifepristone
for the treatment of psychotic depression to perform a successful
interim analysis, and advancing more of our next generation selective
GR-II antagonists towards human use. 
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 10-15 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(TM) 
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 Corcept Therapeutics Incorporated 
Corcept is a pharmaceutical company engaged in the discovery,
development and commercialization of drugs for the treatment of
severe metabolic and psychiatric disorders. Korlym, a first
generation GR-II antagonist, is the company's first FDA-approved
medication. The company has a phase 3 trial underway for mifepristone
for treatment of the psychotic features of psychotic depression and a
portfolio of selective GR-II antagonists that block the effects of
cortisol but not progesterone. It owns extensive intellectual
property covering the use of GR-II antagonists, including
mifepristone, in the treatment of a wide variety of metabolic and
psychiatric disorders. It also holds composition of matter patents
for its selective GR-II 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, including statements
relating to the company's 2013 objectives. 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,
                                                     2012           2011    
                                                -------------  -------------
                                                 (Unaudited)       (Note)   
                                                                            
ASSETS:                                                                     
  Cash and cash equivalents                     $      93,032  $      39,635
  Trade receivables, net                                  557              -
  Inventory                                             4,663              -
  Other assets                                            914            198
                                                -------------  -------------
    Total assets                                $      99,166  $      39,833
                                                =============  =============
                                                                            
LIABILITIES AND STOCKHOLDERS' EQUITY:                                       
  Accounts payable                              $       3,804  $       3,611
  Deferred revenue                                         16              -
  Long-term obligation                                 31,680              -
  Other liabilities                                     1,889          1,415
  Stockholders' equity                                 61,777         34,807
                                                -------------  -------------
    Total liabilities and stockholders' equity  $      99,166  $      39,833
                                                =============  =============

 
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,     
                                 --------------------  -------------------- 
                                                                            
                                    2012       2011       2012       2011   
                                 ---------  ---------  ---------  --------- 
                                                                            
Revenues:                                                                   
  Product sales, net             $   1,377  $       -  $   3,307  $       - 
                                                                            
Operating expenses:                                                         
  Cost of sales                         19          -         91          - 
  Research and development           4,856      6,645     14,074     21,001 
  Selling, general and                                                      
   a
dministrative                    6,482      3,283     25,414     11,331 
                                 ---------  ---------  ---------  --------- 
    Total operating expenses        11,357      9,928     39,579     32,332 
                                 ---------  ---------  ---------  --------- 
Loss from operations                (9,980)    (9,928)   (36,272)   (32,332)
                                                                            
Interest and other income, net           -          1          -          3 
Interest and other expense          (1,144)        (9)    (1,776)       (25)
                                 ---------  ---------  ---------  --------- 
    Net loss                     $ (11,124) $  (9,936) $ (38,048) $ (32,354)
                                 =========  =========  =========  ========= 
                                                                            
Basic and diluted net loss per                                              
 share                           $   (0.11) $   (0.12) $   (0.41) $   (0.39)
                                 =========  =========  =========  ========= 
                                                                            
Shares used in computing basic                                              
 and diluted net loss per share     99,796     84,225     93,015     83,309 
                                 =========  =========  =========  ========= 
                                                                            
                                                                            
                     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,     
                                 --------------------  -------------------- 
                                                                            
                                    2012       2011       2012       2011   
                                 ---------  ---------  ---------  --------- 
                                                                            
GAAP net loss                    $ (11,124) $  (9,936) $ (38,048) $ (32,354)
                                                                            
Significant non-cash expenses:                                              
  Stock-based compensation                                                  
    Research and development           130        114        546        547 
    Selling, general and                                                    
     administrative                    916        918      4,764      2,888 
                                 ---------  ---------  ---------  --------- 
      Total stock-based                                                     
       compensation                  1,046      1,032      5,310      3,435 
                                 ---------  ---------  ---------  --------- 
  Accretion of interest expense                                             
   related to long-term                                                     
   obligation                        1,105          -      1,680          - 
                                 ---------  ---------  ---------  --------- 
    Non-GAAP net loss            $  (8,973) $  (8,904) $ (31,058) $ (28,919)
                                 =========  =========  =========  ========= 
                                                                            
                                                                            
GAAP basic and diluted net loss                                             
 per share                       $   (0.11) $   (0.12) $   (0.41) $   (0.39)
                                 =========  =========  =========  ========= 
                                                                            
Non-GAAP basic and diluted net                                              
 loss per share as adjusted for                                             
 significant non-cash expenses   $   (0.09) $   (0.11) $   (0.33) $   (0.35)
                                 =========  =========  =========  ========= 
                                                                            
Shares used in computing basic                                              
 and diluted net loss per share     99,796     84,225     93,015     83,309 
                                 =========  =========  =========  ========= 

  
CONTACT:
Charles Robb
Chief Financial Officer
Corcept Therapeutics
650-688-8783
crobb@corcept.com
www.corcept.com 
 
 
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