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Cornerstone Therapeutics Inc. Reports Third Quarter 2012 Financial Results  
11/8/2012 9:20:23 AM

CARY, NC--(Marketwire - November 08, 2012) -

Cornerstone Therapeutics Inc. (NASDAQ: CRTX)

  • Net product sales increased 49% year over year
  • Net income increased tenfold year over year
  • Integration of EKR Therapeutics completed ahead of schedule

Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets, today announced results for the quarter ended September 30, 2012.

Total net revenues were $37.5 million for the third quarter of 2012 versus $25.2 million reported for the third quarter of 2011, an increase of 49%. Net sales from the ZYFLO® family of products and CUROSURF® amounted to $14.5 million and $10.0 million, respectively, up 74% and 7%, respectively, for the third quarter of 2012 versus the third quarter of 2011. CARDENE® I.V. net sales were $12.8 million for its first full quarter in 2012.

Net income for the third quarter of 2012 was $1.2 million, or $0.05 per diluted share, compared to net income of $117,000, or no earnings per diluted share, for the third quarter of 2011. On a non-GAAP basis, net income for the third quarter of 2012 was $5.6 million, or $0.19 per diluted share, an increase of 66% from non-GAAP income of $3.4 million, or $0.13 per diluted share, in the third quarter of 2011. Non-GAAP net income and net income per diluted share exclude stock-based compensation expense, amortization of product rights, amortization of debt financing costs, acquisition adjustments related to inventory sold, transaction-related expenses, the change in acquisition-related contingent payments, and the gain on the divestiture of certain product rights.

"We laid out a transformative strategic plan in June 2011, and I am pleased to say we've come a long way in reshaping Cornerstone as a specialty pharmaceutical player in the hospital and related specialty market," said Craig A. Collard, Chief Executive Officer of Cornerstone Therapeutics. "The integration of EKR Therapeutics was completed successfully and rapidly, well ahead of our plans, and we are on track to achieve in excess of $8 million in synergies during the second half of 2012. We plan to use our positive momentum to seek out additional acquisition opportunities to fuel our growth."

As part of the acquisition of EKR Therapeutics, Inc., Cornerstone acquired full product rights to CARDENE I.V. and RETAVASE®. Cornerstone began to actively market CARDENE I.V. at the end of the second quarter and the third quarter of 2012 marked the first full quarter of results.

A breakdown of net revenues by product for the three and nine months ended September 30, 2012 (in thousands, except percentages) follows:

                                                                            
                 Three Months                   Nine Months                 
                    Ended                          Ended                    
                September 30,      Change      September 30,      Change    
               --------------- -------------  --------------- ------------- 
                 2012    2011     $       %     2012    2011      $      %  
               ------- ------- -------  ----  ------- ------- -------- ---- 
Net product                                                                 
 sales                                                                      
  CUROSURF     $ 9,963 $ 9,347 $   616     7% $26,845 $25,402 $  1,443    6%
  ZYFLO product                                                             
   family       14,495   8,316   6,179    74   37,731  22,313   15,418   69 
  CARDENE I.V.                                                              
   product                                                                  
   family       12,778       -  12,778   100   13,514       -   13,514  100 
  ALLERX® Dose                                                              
   Pack                                                                     
   products          -   5,437  (5,437) (100)  (1,125) 26,191  (27,316)(104)
  Anti-                                                                     
   infective                                                                
   products        281   1,645  (1,364)  (83)   3,374  11,278   (7,904) (70)
  Other                                                                     
   products          8     433    (425)  (98)     814  (2,067)   2,881  139 
               ------- ------- -------        ------- ------- --------      
  Total net                                                                 
   product                                                                  
   sales        37,525  25,178  12,347    49   81,153  83,117   (1,964)  (2)
License and                                                                 
 royalty                                                                    
 agreement                                                                  
 revenues            -       2      (2) (100)       4      99      (95) (96)
               ------- ------- -------        ------- ------- --------      
Net revenues   $37,525 $25,180 $12,345    49  $81,157 $83,216 $ (2,059)  (2)
               ------- ------- -------        ------- ------- --------      
                                                                            

Conference Call Information

Cornerstone Therapeutics Inc. will host a conference call at 8:30 a.m. ET today to discuss financial results. To participate in the live conference call, please dial 888-296-4217 (U.S. callers) or 719-325-4746 (international callers), and provide passcode 2185410. A live webcast of the call will also be available through the Investor Relations section of the Company's website. Please allow extra time prior to the webcast to register, download and install any necessary audio software.

The conference call and webcast will be archived for 30 days. The telephone replay of the call will be available approximately two hours after completion of the call by dialing 888-203-1112 (U.S. callers) or 719-457-0820 (international callers) and providing passcode 2185410.

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets. Key elements of the Company's strategy are to focus its commercial and internal development efforts in the hospital and related specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies, marketed and/or registration-stage products, and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc.

Use of Non-GAAP Financial Measures

To supplement the consolidated financial statements presented in accordance with GAAP, the Company uses non-GAAP measures of certain components of financial performance. These non-GAAP measures include non-GAAP operating income, non-GAAP net income and non-GAAP net income per diluted share. The Company's management regularly uses supplemental non-GAAP financial measures to understand, manage and evaluate its business and make operating decisions. These non-GAAP measures are among the primary factors management uses in planning for and forecasting future periods.

These non-GAAP measures are not in accordance with, or an alternative to, measures prepared in accordance with GAAP and may be different from similarly titled non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. The additional non-GAAP financial information presented in this press release should be considered in conjunction with, and not as a substitute for, or superior to, the financial information presented in accordance with GAAP (such as operating income (loss), net income (loss) and earnings (loss) per share) and should not be considered measures of the Company's liquidity. These non-GAAP measures should only be used to evaluate the Company's results of operations in conjunction with the corresponding GAAP measures.

The non-GAAP financial measures reflect adjustments for stock-based compensation expense, amortization of product rights, amortization of debt financing costs, acquisition adjustments related to inventory sold, transaction-related expenses, the change in acquisition-related contingent payments, and the gain on the divestiture of certain product rights. The Company excludes these items from its non-GAAP measures because it believes that their exclusion provides an additional means to assess the extent to which the Company's efforts and execution of its strategy are reflected in its operating results. In particular, stock-based compensation expense is excluded primarily because it is a non-cash expense that is determined based on subjective assumptions; product rights amortization is excluded because it is not reflective of the cash-settled expenses incurred related to product sales; debt financing costs amortization is excluded because it is not reflective of the cash-settled expenses incurred related to the Company's debt; and the acquisition adjustment related to inventory sold, transaction-related expenses, the Company's gain on acquisition contingent payments, and the Company's gain on the divestiture of certain product rights are excluded because management believes they have no direct correlation to current operating results. Management believes that these non-GAAP measures, when shown in conjunction with the corresponding GAAP measures, enhance investors' and management's overall understanding of the Company's current financial performance and its prospects for the future.

The non-GAAP measures are subject to inherent limitations because (1) they do not reflect all of the expenses associated with the results of operations as determined in accordance with GAAP and (2) the exclusion of these items involved the exercise of judgment by management. Even though the Company has excluded stock-based compensation expense, amortization of product rights, amortization of debt financing costs, acquisition adjustments related to inventory sold, transaction-related expenses, the change in acquisition-related contingent payments, and the gain from the divestiture of product rights from the non-GAAP financial measures, stock-based compensation is an integral part of the Company's compensation structure, the acquisition of additional companies and/or product rights and the divestiture of the Company's Factive and Spectracef product rights are an important part of its business strategy, the Company has incurred substantial indebtedness to fund its growth strategy and transaction-related expenses, whether or not the transaction is successfully closed, may be significant cash expenses.

Safe Harbor Statement

Statements in this press release regarding the progress and timing of our product development programs and related trials; our future opportunities; our strategy, future operations and opportunities, including our plans regarding the manner and timing for the manufacture and sale of our newly-acquired cardiovascular products, anticipated financial position, future revenues and projected costs; our management's prospects, plans and objectives; and any other statements about management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Any statements that are not statements of historical fact (including, without limitation, statements containing the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements.

There are a number of important factors that could cause our actual results or events to differ materially from those indicated by such forward-looking statements, including risks relating to our "critical accounting estimates"; our ability to develop and maintain the necessary sales, marketing, supply chain, distribution and manufacturing capabilities to commercialize our products; our ability to replace the revenues from our marketed unapproved products, which we ceased manufacturing and distributing at the end of 2010, our propoxyphene products, which we voluntarily withdrew from the U.S. market in November 2010 at the request of the U.S. Food and Drug Administration, or FDA, and our anti-infective products, which we divested in March 2012; the adverse impact of returns of previously sold inventory; patient, physician and third-party payer acceptance of our products as safe and effective therapeutic products; our heavy dependence on the commercial success of a relatively small number of currently marketed products; our ability to maintain regulatory approvals to market and sell our products; our ability to obtain FDA approval to manufacture, market and sell our products and product candidates, including our lixivaptan compound, CRTX 080, and RETAVASE; our ability to successfully and effectively launch our Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Suspension product (formerly known as CRTX 067); our ability to enter into additional strategic licensing, product acquisition, collaboration or co-promotion transactions on favorable terms, if at all; our ability to manage and control unknown liabilities in connection with any acquisitions; our ability to successfully manage growth or integrate acquired businesses and operations; our ability to maintain compliance with NASDAQ listing requirements; adverse side effects experienced by patients taking our products; difficulties relating to clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies and clinical trials with respect to our product candidates and whether such results will be indicative of results obtained in later clinical trials; our ability to develop and commercialize our product candidates before our competitors develop and commercialize competing products; our ability to satisfy FDA and other regulatory requirements; our substantial indebtedness and debt covenants; and our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the SEC on March 6, 2012 and in our subsequent filings with the SEC. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

In addition, the statements in this press release reflect our expectations and beliefs only as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as may be required by law. Our forward-looking statements do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this release.

TRADEMARKS

CUROSURF® is owned by Chiesi Farmaceutici S.p.A. and is licensed to Cornerstone Therapeutics for sales and marketing purposes in the United States. CARDENE® I.V. and RETAVASE® are registered trademarks of EKR Therapeutics, Inc. ZYFLO CR® and ZYFLO® are registered trademarks of Cornerstone Therapeutics Inc.

FINANCIAL TABLES FOLLOW

                                                                            
                                                                            
                     CORNERSTONE THERAPEUTICS INC.                          
           CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)           
                              (UNAUDITED)                                   
            (In thousands, except share and per share data)                 
                                                                            
                               Three Months Ended      Nine Months Ended    
                                 September 30,           September 30,      
                            ----------------------- ----------------------- 
                                2012        2011        2012        2011    
                            ----------- ----------- ----------- ----------- 
Net revenues                $    37,525 $    25,180 $    81,157 $    83,216 
Costs and expenses:                                                         
  Cost of product sales                                                     
   (exclusive of                                                            
   amortization of product                                                  
   rights)                       14,397       9,960      31,984      29,183 
  Selling, general and                                                      
   administrative                12,933      11,239      32,745      36,113 
  Research and development        1,998         199       3,729       1,372 
  Gain on divestiture of                                                    
   product rights                     -           -      (1,492)          - 
  Transaction-related                                                       
   expenses                       1,764           -       7,944           - 
  Amortization of product                                                   
   rights                         5,284       3,591      13,774      13,277 
  Change in acquisition-                                                    
   related contingent                                                       
   payments                      (1,574)          -      (1,574)          - 
                            ----------- ----------- ----------- ----------- 
    Total costs and                                                         
     expenses                    34,802      24,989      87,110      79,945 
                            ----------- ----------- ----------- ----------- 
Income (loss) from                                                          
 operations                       2,723         191      (5,953)      3,271 
Other expenses:                                                             
  Interest expense, net          (1,684)        (38)     (1,799)       (121)
  Other expense, net               (215)          -        (215)          - 
                            ----------- ----------- ----------- ----------- 
    Total other expenses         (1,899)        (38)     (2,014)       (121)
                            ----------- ----------- ----------- ----------- 
Income (loss) before income                                                 
 taxes                              824         153      (7,967)      3,150 
                            ----------- ----------- ----------- ----------- 
Benefit from (provision                                                     
 for) income taxes                  425         (36)      3,038      (1,094)
                            ----------- ----------- ----------- ----------- 
Net income (loss)           $     1,249 $       117 $    (4,929)$     2,056 
                            =========== =========== =========== =========== 
                                                                            
Comprehensive income (loss) $     1,249 $       117 $    (4,929)$     2,056 
                            =========== =========== =========== =========== 
                                                                            
Net income (loss) per                                                       
 share, basic               $      0.05 $      0.00 $     (0.19)$      0.08 
                            =========== =========== =========== =========== 
Net income (loss) per                                                       
 share, diluted             $      0.05 $      0.00 $     (0.19)$      0.08 
                            =========== =========== =========== =========== 
Weighted-average common                                                     
 shares, basic               26,245,765  25,782,481  26,040,695  25,646,455 
                            =========== =========== =========== =========== 
Weighted-average common                                                     
 shares, diluted             26,603,258  26,331,700  26,040,695  26,223,317 
                            =========== =========== =========== =========== 
                                                                            
                                                                            
                                                                            
                        CORNERSTONE THERAPEUTICS INC.                       
                         CONSOLIDATED BALANCE SHEETS                        
               (In thousands, except share and per share data)              
                                                                            
                                                                            
                                                September 30,               
                                                    2012       December 31, 
                                                 (Unaudited)       2011     
                                               -------------- --------------
Assets                                                                      
Current assets:                                                             
  Cash and cash equivalents                    $       34,179 $       73,968
  Accounts receivable, net                             24,562         11,894
  Inventories, net                                     38,173          9,419
  Prepaid expenses                                      4,107          3,753
  Income tax receivable                                 4,241          1,900
  Deferred tax asset                                    1,228              2
  Other current assets                                 13,035          6,112
                                               -------------- --------------
    Total current assets                              119,525        107,048
                                               -------------- --------------
Property and equipment, net                             1,516          1,574
Product rights, net                                   247,766        106,960
Goodwill                                               38,324         15,218
Amounts due from related parties                            -             38
Deferred tax asset, less current portion                    -            523
Other assets                                               32            953
                                               -------------- --------------
    Total assets                               $      407,163 $      232,314
                                               ============== ==============
Liabilities and Stockholders' Equity                                        
Current liabilities:                                                        
  Accounts payable                             $       20,232 $       10,012
  Accrued expenses                                     39,308         37,125
  Acquisition-related contingent payments               5,778              -
  Deferred revenue                                          -          1,428
  Other current liabilities                               464             90
                                               -------------- --------------
    Total current liabilities                          65,782         48,655
                                               -------------- --------------
Acquisition-related contingent payments, less                               
 current portion                                       37,633          8,800
Long-term debt                                         89,515              -
Deferred tax liability                                 36,077              -
Other long-term liabilities                             4,936             56
                                               -------------- --------------
    Total liabilities                                 233,943         57,511
                                               -------------- --------------
                                                                            
Stockholders' equity                                                        
  Preferred stock - $0.001 par value,                                       
   5,000,000 shares authorized; no shares                                   
   issued and outstanding                                   -              -
  Common stock - $0.001 par value, 90,000,000                               
   shares authorized; 26,305,033 and                                        
   25,803,864 shares issued and outstanding as                              
   of September 30, 2012 and December 31,                                   
   2011, respectively                                      26             26
  Additional paid-in capital                          166,549        163,203
  Retained earnings                                     6,645         11,574
                                               -------------- --------------
    Total stockholders' equity                        173,220        174,803
                                               -------------- --------------
    Total liabilities and stockholders' equity $      407,163 $      232,314
                                               ============== ==============
                                                                            
                                                                            
                                                                            
                       CORNERSTONE THERAPEUTICS INC.                        
                   CONSOLIDATED STATEMENTS OF CASH FLOWS                    
                                (UNAUDITED)                                 
                               (In thousands)                               
                                                       Nine Months Ended    
                                                         September 30,      
                                                   ------------------------ 
                                                       2012         2011    
                                                   -----------  ----------- 
Cash flows from operating activities                                        
Net (loss) income                                  $    (4,929) $     2,056 
Adjustments to reconcile net (loss) income to net                           
 cash (used in) provided by operating activities:                           
  Amortization and depreciation                         14,267       11,146 
  Amortization of debt costs                                26            - 
  Provision for prompt payment discounts                 2,390        2,781 
  Provision for inventory allowances                       847          339 
  Acquisition accounting adjustment on inventory                            
   sold                                                  3,061            - 
  Gain on sale of product rights                        (1,492)           - 
  Loss on disposal of property and equipment               215            - 
  Change in acquisition-related contingent                                  
   payments                                             (1,574)           - 
  Impairment of product rights                               -        2,500 
  Stock-based compensation                               2,027        1,586 
  Deferred revenue                                      (1,428)     (54,856)
  Benefit from deferred income taxes                       177        1,223 
Changes in operating assets and liabilities:                                
  Accounts receivable                                   (7,654)      56,615 
  Inventories                                           (1,001)       2,540 
  Prepaid expenses and other assets                      8,289        7,508 
  Accounts payable                                      (2,441)       2,003 
  Accrued expenses                                     (14,224)      (3,083)
  Income taxes receivable                               (2,341)      (2,007)
                                                   -----------  ----------- 
    Net cash (used in) provided by operating                                
     activities                                         (5,785)      30,351 
                                                   -----------  ----------- 
Cash flows from investing activities                                        
Acquisition of business, net of cash acquired         (125,921)           - 
Purchase of property and equipment                        (265)        (574)
Proceeds from sale of product rights                     3,000            - 
                                                   -----------  ----------- 
  Net cash used in investing activities               (123,186)        (574)
                                                   -----------  ----------- 
Cash flows from financing activities                                        
Proceeds from term loans                                90,000            - 
Proceeds of debt financing costs                          (511)           - 
Proceeds from exercise of common stock options and                          
 warrants                                                1,157          368 
Excess tax benefit from stock-based compensation           284          513 
Payments related to net settlement of restricted                            
 stock                                                    (122)           - 
Acquisition-related contingent payments                 (1,603)           - 
Principal payments on capital lease obligation             (23)         (62)
                                                   -----------  ----------- 
  Net cash provided by financing activities             
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