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8-K - FORM 8-K - CORNERSTONE THERAPEUTICS INCb85265e8vk.htm
Exhibit 99.1
(ORNERSTONE LOGO)
FOR IMMEDIATE RELEASE
     Cornerstone Therapeutics Reports Fiscal Year 2010 Financial Results
    Net revenues increased 14% year-over-year to a record $125.3 million
 
    Curosurf® achieved new market share high for full year 2010
 
    Cash balance at year end grew to $50.9 million
CARY, N.C., March 3, 2011- Cornerstone Therapeutics Inc. (NASDAQ: CRTX) today reported full year and fourth quarter 2010 results. Total net revenues were $125.3 million for the full year of 2010, representing a 14% increase over the $109.6 million reported for the full year of 2009. Total net revenues for the fourth quarter of 2010 were $32.5 million representing a 6% increase over the $30.8 million for the fourth quarter of 2009. Net product sales from strategic products were 60% of total net revenues, or $74.7 million, for the full year of 2010, an increase from the 36% of total net revenues, or $39.0 million, for the full year of 2009. Net product sales from strategic products were 66% of total net revenues, or $21.4 million, for the fourth quarter of 2010, an increase from the 52% of total net revenues, or $16.0 million, for the fourth quarter of 2009.
Net income for 2010 was $6.2 million, or $0.24 per diluted share, compared to net income of $10.2 million, or $0.54 per diluted share in 2009. Fourth quarter net income was $0.8 million, or $0.03 per diluted share, compared to $2.7 million, or $0.10 per diluted share, for the fourth quarter of 2009. On a non-GAAP basis, net income for 2010 was $18.9 million, or $0.73 per diluted share, compared to non-GAAP net income of $17.4 million, or $0.93 per diluted share in 2009. On a non-GAAP basis, fourth quarter net income was $5.2 million, or $0.20 per diluted share, compared to non-GAAP net income of $5.5 million, or $0.21 per diluted share for the fourth quarter of 2009. Non-GAAP net income and net income per diluted share exclude amortization of product rights, acquisition-related expenses in connection with the 2009 transaction with Chiesi Farmaceutici S.p.A., and stock-based compensation.
“Cornerstone ended 2010 with record net sales, a strong cash position and a more focused product portfolio,” said Craig A. Collard, Cornerstone’s President and Chief Executive Officer. “As a result of the efforts of the company’s dedicated employees, we achieved another record year in net revenues, including a new market share high with Curosurf; we also successfully distributed the remaining inventory as the final phase in our plan to cease manufacturing and distribution of AlleRx® and HyoMax® and generated significant cash.”
Mr. Collard continued, “We believe that the momentum built in 2010 positions us to build a portfolio of products that will leverage our presence in the respiratory and hospital markets while we continue to advance our internal pipeline.”
A breakdown of net revenues by product for the fourth quarter and year ended December 31, 2010 (in thousands, except percentages) follows:

 


 

                                                                 
    Three Months Ended December 31,     Change     Year Ended December 31,     Change  
    2010     2009     $     %     2010     2009     $     %  
Net Product Sales
                                                               
Curosurf
  $ 9,854     $ 8,310     $ 1,544       19 %   $ 33,621     $ 10,463     $ 23,158       221 %
Zyflo® product family
    8,764       4,122       4,642       113       30,619       17,959       12,660       70  
Factive®
    963       1,087       (124 )     (11 )     5,126       1,178       3,948       335  
Spectracef® product family
    1,849       2,494       (645 )     (26 )     5,327       9,390       (4,063 )     (43 )
AlleRx Dose Pack products
    5,200       8,722       (3,522 )     (40 )     27,305       31,707       (4,402 )     (14 )
HyoMax product family
    2,270       3,131       (861 )     (27 )     10,071       28,148       (18,077 )     (64 )
Other Products (1)
    3,582       2,883       699       24       11,675       10,443       1,232       12  
         
Total net product sales
    32,482       30,749       1,733       6       123,744       109,288       14,456       13  
License and royalty agreement revenues
    32       39       (7 )     (18 )     1,573       276       1,297       470  
         
Net Revenues
  $ 32,514     $ 30,788     $ 1,726       6 %   $ 125,317     $ 109,564     $ 15,753       14 %
         
 
 (1)   Primarily propoxyphene/acetaminophen products.
Gross margin percentage for the full year of 2010 was 74% compared to 82% for the full year of 2009. The lower gross margin percentage compared to the prior period was due to a relatively higher portion of our net product sales in 2010 derived from products that have lower gross margins, specifically Curosurf. Gross margin percentage for the fourth quarter was 70%, similar to the fourth quarter of 2009.
Selling, general and administrative expenses increased $7.5 million, or 16%, for the full year of 2010 compared to 2009. The increase was primarily related to our incurring a full year of expenses in 2010 for our hospital sales force that we created in September 2009, co-promotion expenses relating to Zyflo CR and increased sample usage for both Zyflo CR and Factive, partially offset by lower stock compensation and reduced legal and consulting costs during 2010 as compared to 2009 when we incurred significant expenses related to the Chiesi transaction. Selling, general and administrative expenses during the fourth quarter increased $4.0 million, or 36%, compared to the fourth quarter of 2009. The increase was primarily related to co-promotion expenses relating to Zyflo CR and AlleRx and increased sample usage for both Zyflo CR and Factive.
Royalty expenses decreased $6.1 million, or 32%, during 2010 compared to 2009. The reduction in royalty expense was primarily due to lower net revenues from our HyoMax products, partially offset by increased royalties for Zyflo CR and Factive. Royalty expenses increased $0.6 million, or 28% during the fourth quarter of 2010 compared to the fourth quarter of 2009 primarily due to product mix.
As of December 31, 2010, the Company had $50.9 million in cash and cash equivalents, an increase of 170%, compared to $18.9 million as of December 31, 2009.
Conference Call Information
Cornerstone Therapeutics will host a conference call today at 8:30 AM ET to discuss its financial results for the quarter and twelve months ended December 31, 2010. To participate in the live conference call, please dial 866-730-5770 (U.S. callers) or 857-350-1594 (international callers), and provide passcode 99190634. A live webcast of the call will also be available through the “Investors—Webcasts & Presentations” section of the Company’s website at http://www.crtx.com. Please allow extra time prior to the webcast to register for the webcast and to download and install any necessary audio software.
The conference call and the webcast will be archived for 30 days. The telephone replay of the call will be available today at 11:30 AM ET, by dialing 888-286-8010 (U.S. callers) or 617-801-6888 (international callers), and providing passcode 56948345.

 


 

About Cornerstone Therapeutics
Cornerstone Therapeutics Inc. (Nasdaq: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on acquiring, developing and commercializing products for the respiratory and related markets. Key elements of the Company’s strategy are to leverage commercial capabilities by promoting respiratory and related products to high prescribing physicians through its respiratory sales force and to hospital-based healthcare professionals through its hospital sales force; acquire rights to existing patent- or trade secret-protected, branded products, which can be promoted through the same channels to generate on-going high-value earnings streams; advance its development projects and further build a robust pipeline; and generate revenues by marketing approved generic products through its wholly owned subsidiary, Aristos Pharmaceuticals, Inc.
Use of Non-GAAP Financial Measures
This press release highlights the Company’s financial results on both a GAAP and a non-GAAP basis. The GAAP results include certain costs and charges that are excluded from non-GAAP results. By publishing the non-GAAP financial measures, management intends to provide investors with additional information to further analyze the Company’s performance and underlying trends. Management evaluates results and makes operating decisions using both GAAP and non-GAAP measures included in this press release. Non-GAAP results are not prepared in accordance with GAAP, and non-GAAP information should be considered a supplement to, and not a substitute for, financial statements prepared in accordance with GAAP. Investors and potential investors are encouraged to review the reconciliation of non-GAAP financial measures to their most directly comparable GAAP measures attached to this press release.
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, 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,” “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 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, and from 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; patient, physician and third-party payor 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 with FDA-approved marketing applications; our ability to obtain FDA approval to market and sell our products under development; our ability to enter into additional strategic licensing product acquisition, collaboration or co-promotion transactions on favorable terms, if at all; our ability to maintain compliance with NASDAQ listing requirements; adverse side effects experienced by patients taking our products; our ability to develop and commercialize our product candidates before our competitors develop and commercialize competing 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 satisfy FDA and other regulatory requirements; 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 Securities and Exchange Commission (the SEC) on March 4, 2010 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 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. 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. Spectracef® is owned by Meiji Seika Kaisha Ltd. Factive® is owned by LG Life Sciences, Ltd. Curosurf, Spectracef and Factive are licensed to Cornerstone Therapeutics for sales and marketing purposes in the United States and, with respect to Factive, certain other countries.
FINANCIAL TABLES FOLLOW
Contacts
Investor Relations Contacts:
Westwicke Partners, John Woolford, +1-443-213-0506, john.woolford@westwicke.com or Westwicke
Partners, Stefan Loren, Ph.D., +1-443-213-0507, sloren@westwicke.com;
Media Relations Contact:
Fleishman-Hillard, Andrea Moody, +1-919-457-0743, andrea.moody@fleishman.com
###

 


 

CORNERSTONE THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except share and per share data)
                                 
    Three Months Ended     Year Ended  
    December 31,     December 31,  
    2010     2009     2010     2009  
    (Unaudited)                  
Net revenues
  $ 32,514     $ 30,788     $ 125,317     $ 109,564  
Costs and expenses:
                               
Cost of product sales (exclusive of amortization of product rights)
    9,599       9,212       32,313       19,457  
Selling, general and administrative
    15,109       11,112       53,198       45,731  
Royalties
    2,856       2,240       12,702       18,775  
Research and development
    740       1,163       4,488       3,608  
Amortization of product rights
    3,943       3,587       14,728       6,115  
         
Total costs and expenses
    32,247       27,314       117,429       93,686  
         
Income from operations
    267       3,474       7,888       15,878  
         
Other expenses:
                               
Interest expense, net
    (38 )     (15 )     (85 )     (128 )
Other expense, net
                (25 )      
         
Total other expenses
    (38 )     (15 )     (110 )     (128 )
         
Income before income taxes
    229       3,459       7,778       15,750  
Benefit from (provision for) income taxes
    563       (771 )     (1,609 )     (5,547 )
         
Net income
  $ 792     $ 2,688     $ 6,169     $ 10,203  
         
Net income per share, basic
  $ 0.03     $ 0.11     $ 0.24     $ 0.58  
         
Net income per share, diluted
  $ 0.03     $ 0.10     $ 0.24     $ 0.54  
         
Weighted-average common shares, basic
    25,463,467       24,972,954       25,412,636       17,651,668  
         
Weighted-average common shares, diluted
    26,093,755       25,751,756       26,036,544       18,776,588  
         

 


 

CORNERSTONE THERAPEUTICS INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
                 
    December 31,     December 31,  
    2010     2009  
     
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 50,945     $ 18,853  
Accounts receivable, net
    76,476       16,548  
Inventories, net
    15,174       18,106  
Prepaid and other current assets
    5,111       4,808  
Income tax receivable
    197        
Deferred income tax asset
    6,599       3,507  
     
Total current assets
    154,502       61,822  
     
Property and equipment, net
    1,486       1,312  
Product rights, net
    112,328       126,806  
Goodwill
    13,231       13,231  
Amounts due from related parties
    38       38  
Long-term accounts receivable and other assets
    8,553       113  
Total assets
  $ 290,138     $ 203,322  
     
Liabilities and Stockholders’ Equity
               
Current liabilities:
               
Accounts payable
  $ 7,671     $ 7,172  
Accrued expenses
    46,599       23,703  
Current portion of license agreement liability
    1,368       1,019  
Current portion of capital lease
    83       10  
Current portion of deferred revenue
    37,616        
Income taxes payable
          1,606  
     
Total current liabilities
    93,337       33,510  
     
License agreement liability, less current portion
          1,341  
Capital lease, less current portion
    146       39  
Deferred revenue, less current portion
    19,578        
Deferred income tax liability
    4,679       4,564  
     
Total liabilities
    117,740       39,454  
     
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; 25,472,963 and 25,022,644 shares issued and outstanding as of December 31, 2010 and December 31, 2009, respectively
    25       25  
Additional paid-in capital
    160,106       157,745  
Retained earnings
    12,267       6,098  
     
Total stockholders’ equity
    172,398       163,868  
     
Total liabilities and stockholders’ equity
  $ 290,138     $ 203,322  
     

 


 

CORNERSTONE THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
                 
    Year Ended December 31,  
    2010     2009  
Cash flows from operating activities
               
Net income
  $ 6,169     $ 10,203  
Adjustments to reconcile net income to net cash provided by operating activities:
               
Amortization and depreciation
    14,778       6,392  
Provision for prompt payment discounts
    3,903       3,157  
Provision for inventory allowances
    1,340       1,474  
Loss on sale of property and equipment
    25        
Impairment of product rights
    350        
Stock-based compensation
    1,339       3,291  
Benefit from deferred income taxes
    (2,977 )     (3,632 )
Changes in operating assets and liabilities:
               
Accounts receivable
    (63,831 )     (6,718 )
Inventories
    1,592       (8,202 )
Prepaid expenses, long-term accounts receivable and other assets
    (8,743 )     (3,121 )
Accounts payable
    499       (3,116 )
Accrued expenses
    23,154       2,053  
Income taxes payable/receivable
    (1,803 )     (1,331 )
Deferred revenue
    57,194        
     
Net cash provided by operating activities
    32,989       450  
     
Cash flows from investing activities
               
Proceeds from sale of marketable securities
          300  
Proceeds from sale of property and equipment
    2        
Purchase of property and equipment
    (375 )     (635 )
Purchase of product rights
    (250 )     (5,169 )
     
Net cash used in investing activities
    (623 )     (5,504 )
     
Cash flows from financing activities
               
Proceeds from exercise of common stock options and warrants
    544       437  
Proceeds from issuance of shares of common stock
          15,465  
Payments for cancellation of warrants
          (41 )
Excess tax benefit from stock-based compensation
    478       1,269  
Principal payments on license agreement liability
    (1,250 )     (2,500 )
Principal payments on capital lease obligation
    (46 )     (9 )
     
Net cash (used in) provided by financing activities
    (274 )     14,621  
     
Net increase in cash and cash equivalents
    32,092       9,567  
Cash and cash equivalents as of beginning of year
    18,853       9,286  
     
Cash and cash equivalents as of end of year
  $ 50,945     $ 18,853  
     
 
               
Supplemental disclosure of cash flow information
               
Cash paid during the year for interest
  $ 318     $ 531  
     
Cash paid during the year for income taxes
  $ 6,780     $ 9,260  
     
Supplemental schedule of non-cash investing and financing activities
               
Purchase of property and equipment with capital leases
  $ 226     $  
     
Acquisition of product rights through equity issued and liabilities assumed
  $     $ 110,050  
     

 


 

CORNERSTONE THERAPEUTICS INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(In thousands, except share and per share data — unaudited)
The following tables show the non-GAAP financial measures used in this press release reconciled to the most directly comparable GAAP financial measures.
                                 
    Three Months Ended December 31,     Year Ended December 31,  
    2010     2009     2010     2009  
         
GAAP income from operations
  $ 267     $ 3,474     $ 7,888     $ 15,878  
Add: stock-based compensation1
    369       321       1,339       1,478  
Add: amortization of product rights
    3,943       3,587       14,728       6,115  
Add: acquisition-related expenses2
                      3,563  
         
Non-GAAP income from operations
  $ 4,579     $ 7,382     $ 23,955     $ 27,034  
         
 
                               
GAAP net income
  $ 792     $ 2,688     $ 6,169     $ 10,203  
Add: stock-based compensation1
    369       321       1,339       1,478  
Add: amortization of product rights
    3,943       3,587       14,728       6,115  
Add: acquisition-related expenses2
                      3,563  
Less: tax effects related to above items3
    58       (1,108 )     (3,324 )     (3,927 )
         
Non-GAAP net income
  $ 5,162     $ 5,488     $ 18,912     $ 17,432  
         
 
                               
GAAP net income per share, diluted
  $ 0.03     $ 0.10     $ 0.24     $ 0.54  
         
Non-GAAP net income per share, diluted
  $ 0.20     $ 0.21     $ 0.73     $ 0.93  
         
 
                               
Shares used in diluted net income per share calculation:
                               
GAAP net income
    26,093,755       25,751,756       26,036,544       18,776,588  
         
Non-GAAP net income
    26,093,755       25,751,756       26,036,544       18,776,588  
         
 
1   Stock-based compensation excludes stock-based compensation charges incurred in connection with the Chiesi transaction, which are included in acquisition-related expenses.
 
2   Acquisition-related expenses include stock-based compensation charges and legal, accounting and related costs that resulted from or were incurred in connection with the Chiesi transaction. During 2009, acquisition-related stock-based compensation charges include $1.8 million of charges that were included in selling, general and administrative expenses.
 
3   Tax effects for the three months ended December 31, 2010 and 2009 are calculated using effective tax rates of (1.3)% and 28.4%, respectively. Tax effects for 2010 and 2009 are calculated using effective tax rates of 20.7% and 35.2%, respectively.