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8-K - FORM 8-K - Impax Laboratories, LLCc07617e8vk.htm
Exhibit 99.1
(IMPAX LOGO)
Company Contact:
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 933-3526
www.impaxlabs.com
Impax Laboratories Reports Growth in Revenue,
Profit and Earnings in the Third Quarter 2010
HAYWARD, Calif. (November 2, 2010) — Impax Laboratories, Inc. (NASDAQ: IPXL) today reported adjusted net revenue in the third quarter of 2010, excluding the effect of a change in accounting for revenue received under the Company’s Strategic Alliance Agreement with Teva, increased $42.6 million to $107.6 million compared to the prior year period, driven by sales of generic Adderall XR® for which there were no sales in the third quarter of 2009, as well as increased sales of the Company’s fenofibrate products. Earnings before interest, taxes, depreciation and amortization (EBITDA) for the third quarter of 2010, excluding adjusted items, increased $12.2 million to $27.8 million, compared to $15.6 million in the prior year period. Net income for the third quarter 2010, excluding adjusted items, increased to $15.8 million, or $0.24 per diluted share, compared to $9.0 million, or $0.15 per diluted share, in the prior year period. On a generally accepted accounting principles (GAAP) basis, net revenue in the third quarter of 2010 increased $239.0 million to $304.0 million due to the change in revenue recognition, and net income increased to $75.2 million, or $1.15 per diluted share, compared to $6.7 million, or $0.11 per diluted share in the prior year period.
In July 2010, the Company materially modified its Strategic Alliance Agreement with Teva and applied the revised revenue recognition standards of FASB ASC 605-25 Multiple Element Arrangements. Application of the revised standards resulted in the recognition in the third quarter of 2010 of previously deferred net revenue of $196.4 million that would have been recognized over the remaining life of the Teva agreement under the prior standards. This had the effect of increasing third quarter net revenue by $196.4 million, net income by $61.4 million and net income per diluted share by $0.98. Please refer to the attached information and footnotes on pages 9 and 10 for a further description and reconciliation of adjusted items.
“Our positive third quarter results continued to reflect demand for our generic Adderall XR® and fenofibrate products. However, on-going supply issues of generic Adderall XR® with our supplier Shire Laboratories continued to constrain our ability to fill strong customer demand leading to lower than expected sales and market share. Following numerous attempts to resolve the recent and recurring supply issues, we have initiated litigation alleging breach of contract and other related claims due to Shire’s failure to fill our orders for product.” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories.
Dr. Hsu continued, “With our strong balance sheet consisting of more than $358 million in cash and short-term investments and no debt, we continue to aggressively pursue generic and brand opportunities to acquire products, technologies or companies with compelling business strategies to drive near and long term growth. We also remain excited with the continued development of our late-stage product IPX066 for Parkinson’s disease patients. We recently completed the APEX-PD Phase III study in naïve patients and expect to release the top line results later this year. Enrollment in the ADVANCED-PD Phase III study was completed in late August and we look forward to the completion of this study in early 2011, with data release in the second quarter of 2011. We continue to progress toward filing the new drug application in the fourth quarter of 2011.”

 

 


 

Segment Information
The Company has two reportable segments, the Global Pharmaceuticals Division (generic products) and the Impax Pharmaceuticals Division (brand products) and does not allocate general corporate services to either segment.
Global Pharmaceuticals Division Information
                                 
    Three Months Ended     Nine Months Ended  
    September 30     September 30,  
(Unaudited; amounts in thousands)   2010     2009     2010     2009  
Revenues:
                               
Global Product sales, net
  $ 91,051     $ 46,636     $ 537,794     $ 123,144  
Private Label
    528       1,752       1,539       5,269  
Rx Partner (a)
    202,800       8,328       213,504       30,183  
OTC Partner
    2,365       1,769       6,439       5,255  
Research Partner
    3,384       2,962       10,153       8,406  
Other
                      11  
 
                       
Total Revenues (a)
    300,128       61,447       769,429       172,268  
 
                       
Cost of revenues (a)
    140,279       25,098       282,309       72,339  
 
                       
Gross profit (a)
    159,849       36,349       487,120       99,929  
 
                       
 
                               
Operating expenses:
                               
Research and development
    12,819       8,909       32,608       28,761  
Patent litigation
    1,033       1,647       4,786       4,058  
Selling, general and administrative
    4,127       2,561       11,149       7,628  
 
                       
Total operating expenses
    17,979       13,117       48,543       40,447  
 
                       
Income from operations (a)
  $ 141,870     $ 23,232     $ 438,577     $ 59,482  
     
(a)   The following table reflects the impact on the Global Pharmaceuticals Division results due to the change in revenue recognition to the Company’s Strategic Alliance Agreement with Teva.
                                                 
    Three Months Ended     Nine Months Ended  
  September 30, 2010     September 30, 2010  
(Unaudited; amounts in thousands)   As
Reported
    Impact of
change
   
Adjusted
    As
Reported
    Impact of
change
   
Adjusted
 
Rx Partner
  $ 202,800     $ 196,440     $ 6,360     $ 213,504     $ 196,440     $ 17,064  
Total Revenues
    300,128       196,440       103,688       769,429       196,440       572,989  
Cost of revenues
    140,279       95,426       44,853       282,309       95,426       186,883  
Gross profit
    159,849       101,014       58,835       487,120       101,014       386,106  
Income from operations
  $ 141,870     $ 101,014     $ 40,856     $ 438,577     $ 101,014     $ 337,563  
Excluding the change in revenue recognition under the Teva Agreement, Global Pharmaceuticals Division revenues increased $42.2 million to $103.7 million, driven by a significant increase in Global Product sales, net, as discussed below.

 

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During the third quarter of 2010, Global Product sales, net, increased $44.4 million to $91.1 million over the same period in 2009 primarily due to sales of generic Adderall XR® and, to a lesser extent, increased sales of the Company’s fenofibrate products. Partially offsetting these gains was a $2.0 million decline in Rx Partner revenue (before the change in revenue recognition) and a $1.2 million decline in Private Label revenue. The decline in Rx Partner revenue is primarily attributable to reduced sales of generic Wellbutrin® products as competition continues to erode the Company’s market share, while Private Label product sales declined due to lower demand for the Company’s generic loratadine/PSE products.
Excluding the change in revenue recognition, gross profit increased $22.5 million to $58.8 million primarily due to sales of generic Adderall XR® and an increase in fenofibrate sales. Adjusted gross profit margin of 57% for the third quarter 2010 declined from the 59% margin for the prior year period due to the slightly higher concentration of lower-margin products.
Research and development expenses for the third quarter of 2010 increased $3.9 million to $12.8 million, compared to the prior year primarily due to higher spending on bioequivalency studies, active pharmaceutical ingredients and compensation expenses.
Selling, general and administrative expenses for the third quarter of 2010 increased $1.6 million to $4.1 million due to increased marketing expenses, sales incentives and customer freight, all related to higher sales levels as noted above.
Excluding the change in revenue recognition, Global Pharmaceuticals Division income from operations in the third quarter of 2010 increased $22.9 million to $40.9 million, compared to $17.7 million in the prior year, due to the increase in sales as noted above.
Impax Pharmaceuticals Division Information
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
(Unaudited; amounts in thousands)   2010     2009     2010     2009  
Revenues:
                               
Promotional Partner
  $ 3,535     $ 3,499     $ 10,538     $ 10,007  
Research Partner
    330             440        
 
                       
Total revenues
    3,865       3,499       10,978       10,007  
 
                       
Cost of revenues
    2,843       2,957       9,280       9,250  
 
                       
Gross profit
    1,022       542       1,698       757  
 
                       
 
                               
Operating expenses:
                               
Research and development
    11,027       6,334       30,656       17,983  
Selling, general and administrative
    930       761       2,478       2,528  
 
                       
Total operating expenses
    11,957       7,095       33,134       20,511  
 
                       
Loss from operations
  $ (10,935 )   $ (6,553 )   $ (31,436 )   $ (19,754 )
Impax Pharmaceuticals Division revenues in the third quarter of 2010 were $3.9 million, a slight increase over the prior year due primarily to the addition of Research Partner revenue related to a Development and Co-Promotion Agreement with Endo Pharmaceuticals which was entered into in June 2010.
The Company is currently investing in research and development to develop brand products which provide longer product life cycles and the potential for significantly higher profit margins than generic products. In the third quarter of 2010, research and development expense increased $4.7 million to $11.0 million, primarily due to planned increased spending on clinical studies for the Company’s leading drug candidate for Parkinson’s disease.

 

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The Company’s planned increase in investment in research and development during the third quarter of 2010 contributed to an Impax Pharmaceuticals Division loss from operations of $10.9 million compared to a loss from operations of $6.6 million in the third quarter of 2009.
Corporate and Other Information
                                 
    Three Months Ended     Nine Months Ended  
(Unaudited; amounts in thousands)   September 30,     September 30,  
    2010     2009     2010     2009  
Litigation settlement
  $     $ 818     $     $ 1,674  
General and administrative
    7,575       5,698       23,509       19,770  
 
                       
Total operating expenses
    7,575       6,516       23,509       21,444  
 
                       
Loss from operations
  $ (7,575 )   $ (6,516 )   $ (23,509 )   $ (21,444 )
Total corporate operating expenses for the third quarter of 2010 increased $1.1 million to $7.6 million, due to increased compensation, higher insurance costs related to increasing levels of business activity and an increase in systems implementation expenses.
Cash and Short-Term Investments
Cash and short-term investments were $358.4 million as of September 30, 2010, as compared to $90.4 million as of December 31, 2009. The change in cash and short-term investments from year-end 2009 is due to strong year to date product sales.
2010 Financial Outlook
The Company previously updated its full year 2010 forecast on August 3, 2010. The Company provides this further update to its full year 2010 forecast.
  Cash flows from operating activities, before changes in working capital, less capital expenditures (Free Cash Flow), planned to be positive.
  Updated May 2010 — gross margins as a percent of total revenues to approximate 50% for the balance of the year.
  Updated November 2010 — Total research and development expenses across the generic and brand divisions to approximate $85 million with generic R&D to approximate $43 million (an increase of $2 million due to increased purchases of active pharmaceutical ingredients) and brand R&D to approximate $42 million.
  Updated November 2010 — Patent litigation expenses of approximately $8 million (a decrease of approximately $3 million due to delayed spending on litigation).
  Selling, general and administrative expenses of approximately $50 million.
  Updated May 2010 — estimated consolidated effective tax rate of approximately 40% (without renewal in 2010 of the federal R&D tax credit).
  Capital expenditures expected to be approximately $20 million.
Conference Call Information
The Company will host a conference call today at 11:00 a.m. EDT to discuss its results. The number to call from within the United States is (877) 719-9796 and (719) 325-4778 internationally. The call can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (888) 203-1112 (in the U.S.) and (719) 457-0820 (international callers). The access conference code is 7669744.

 

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About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals Division and markets third-party branded products through the Impax Pharmaceuticals Division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company’s Web site at: www.impaxlabs.com.
Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position, results of operations and market value of its common stock, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, reductions or loss of business with any significant customer, the impact of competitive pricing and products and regulatory actions on the Company’s products, the ability to sustain profitability and positive cash flows, the ability to maintain sufficient capital to fund operations, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the ability to successfully develop and commercialize pharmaceutical products, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, reliance on key alliance, collaboration, license and distribution agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, exposure to product liability claims and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

 

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Impax Laboratories, Inc.
Consolidated Statements of Operations
(Unaudited; amounts in thousands, except share and per share data)
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2010     2009     2010     2009  
Revenues:
                               
Global Pharmaceuticals Division (a)
  $ 300,128     $ 61,447     $ 769,429     $ 172,268  
Impax Pharmaceuticals Division
    3,865       3,499       10,978       10,007  
 
                       
Total Revenues
    303,993       64,946       780,407       182,275  
 
                       
 
                               
Cost of revenues (b)
    143,122       28,055       291,589       81,589  
 
                       
Gross profit (c)
    160,871       36,891       488,818       100,686  
 
                       
 
                               
Operating expenses:
                               
Research and development
    23,846       15,243       63,264       46,744  
Patent litigation
    1,033       1,647       4,786       4,058  
Litigation settlement
          818             1,674  
Selling, general and administrative
    12,632       9,020       37,136       29,926  
 
                       
Total operating expenses
    37,511       26,728       105,186       82,402  
 
                       
Income from operations (c)
    123,360       10,163       383,632       18,284  
 
                       
Other (expense) income, net
    (91 )     (6 )     (134 )     52  
Interest income
    405       180       680       636  
Interest expense
    (38 )     (185 )     (108 )     (735 )
 
                       
Income before income taxes
    123,636       10,152       384,070       18,237  
Provision for income taxes
    48,501       3,495       146,114       6,373  
 
                       
Net income before noncontrolling interest
    75,135       6,657       237,956       11,864  
Add back loss attributable to noncontrolling interest
    28       28       40       53  
 
                       
Net Income (d)
  $ 75,163     $ 6,685     $ 237,996     $ 11,917  
 
                       
 
                               
Net Income per share: (d)
                               
Basic
  $ 1.20     $ 0.11     $ 3.85     $ 0.20  
 
                       
Diluted
  $ 1.15     $ 0.11     $ 3.65     $ 0.20  
 
                       
 
                               
Weighted average common shares outstanding:
                               
Basic
    62,435,116       60,559,064       61,778,465       60,130,608  
Diluted
    65,470,341       61,247,700       65,171,055       60,667,227  
     
(a)   Rx Partner revenue for the three and nine months ended September 30, 2010 includes $196.4 million attributable to a change in revenue recognition under the Teva Agreement.
 
(b)   Cost of revenues for the three and nine months ended September 30, 2010 includes $95.4 million attributable to the change as noted in footnote (a).
 
(c)   Gross profit and income from operations for the three and nine months ended September 30, 2010 includes $101.0 million attributable to the change as noted in footnote (a).
 
(d)   For the three and nine months ended September 30, 2010, net income includes $61.4 million and net income per share includes $0.98 and $0.99, respectively, attributable to the change as noted in footnote (a).

 

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Impax Laboratories, Inc.
Condensed Consolidated Balance Sheets
(amounts in thousands)
                 
    September 30,     December 31,  
    2010     2009  
    (unaudited)          
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 165,772     $ 31,770  
Short-term investments
    192,579       58,599  
Accounts receivable, net
    95,567       185,854  
Inventory, net
    42,036       49,130  
Current portion of deferred product manufacturing costs-alliance agreements
    3,006       11,624  
Current portion of deferred income taxes
    37,114       32,286  
Prepaid expenses and other current assets
    2,958       4,748  
 
           
Total current assets
    539,032       374,011  
 
           
Property, plant and equipment, net
    103,066       101,650  
Deferred product manufacturing costs-alliance agreements
    8,231       96,619  
Deferred income taxes, net
    1,396       48,544  
Other assets
    25,587       12,358  
Goodwill
    27,574       27,574  
 
           
Total assets
  $ 704,886     $ 660,756  
 
           
 
               
Liabilities and Stockholders Equity
               
Current liabilities:
               
Accounts payable
  $ 19,156     $ 23,295  
Accrued expenses
    82,083       62,055  
Accrued income taxes payable
    32,942       31,627  
Accrued profit sharing and royalty expenses
    15,235       53,695  
Current portion of deferred revenue-alliance agreements
    19,438       33,196  
 
           
Total current liabilities
    168,854       203,868  
 
           
Deferred revenue-alliance agreements
    36,773       224,522  
Other liabilities
    13,645       10,139  
 
           
Total liabilities
  $ 219,272     $ 438,529  
 
           
Total stockholders equity
    485,614       222,227  
 
           
Total liabilities and stockholders equity
  $ 704,886     $ 660,756  
 
           

 

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Impax Laboratories, Inc.
Condensed Consolidated Statement of Cash Flows
(Unaudited; amounts in thousands)
                 
    Nine Months Ended September 30,  
    2010     2009  
Cash flows from operating activities:
               
Net income
  $ 237,996     $ 11,917  
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
               
Depreciation
    9,066       7,806  
Amortization of Wachovia 3.5% Debentures discount and deferred financing costs
          301  
 
               
Amortization of Credit Agreement deferred financing costs
    25       50  
Bad debt expense
    215       131  
Deferred income taxes (benefit)
    46,657       (9,430 )
Provision for uncertain tax positions
    35       695  
Tax benefit related to the exercise of employee stock options
    (4,337 )      
Deferred revenue-Alliance Agreements
    22,947       36,388  
Deferred product manufacturing costs-Alliance Agreements
    (9,739 )     (20,853 )
Deferred revenue recognized-Alliance Agreements
    (224,454 )     (43,844 )
Amortization deferred product manufacturing costs-Alliance Agreements
    106,746       29,750  
Accrued profit sharing and royalty expense
    86,985       523  
Profit sharing and royalty payments
    (125,445 )     (455 )
Payments on exclusivity period fee
          (6,000 )
Payments on accrued litigation settlements
    (5,865 )     (8,037 )
Share-based compensation expense
    7,706       5,179  
Accretion of interest income on short-term investments
    (374 )     (424 )
Changes in assets and liabilities:
               
Accounts receivable
    90,072       (18,368 )
Inventory
    7,094       (6,606 )
Prepaid expenses and other assets
    (11,225 )     1,346  
Accounts payable, accrued expenses and income taxes payable
    22,349       14,824  
Other liabilities
    3,431       2,740  
 
           
Net cash provided by (used in) operating activities
  $ 259,885     $ (2,367 )
 
           
 
               
Cash flows from investing activities:
               
Purchase of short-term investments
    (306,784 )     (49,563 )
Maturities of short-term investments
    173,178       47,748  
Purchases of property, plant and equipment
    (10,541 )     (8,405 )
 
           
Net cash (used in) investing activities
  $ (144,147 )   $ (10,220 )
 
           
 
               
Cash flows from financing activities:
               
Repayment of long-term debt
          (12,887 )
Tax benefit related to the exercise of employee stock options
    4,337        
Proceeds from exercise of stock options and purchases under the ESPP
    13,927       3,776  
 
           
Net cash provided by (used in) financing activities
  $ 18,264     $ (9,111 )
 
           
 
               
Net increase (decrease) in cash and cash equivalents
  $ 134,002     $ (21,698 )
Cash and cash equivalents, beginning of period
  $ 31,770     $ 69,275  
Cash and cash equivalents, end of period
  $ 165,772     $ 47,577  

 

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Impax Laboratories, Inc.
Non-GAAP Financial Measures
Total revenues, net income, EBITDA and earnings per share excluding adjusted items are not measures of financial performance under generally accepted accounting principles (“GAAP”) and should not be construed as substitutes for, or superior to, consolidated total revenues, net income and earnings per share as a measure of financial performance. However, management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the Company’s operations and to better understand its business. Further, management believes the inclusion of non-GAAP financial measures provides meaningful supplementary information to and facilitates analysis by investors in evaluating the Company’s financial performance, results of operations and trends. The Company’s calculation of total revenues, net income, EBITDA and earnings per share excluding certain adjusted items may not be comparable to similarly designated measures reported by other companies, since companies and investors may differ as to what type of events warrant adjustment.
The following table provides a summary of GAAP and adjusted results for the three and nine months ended September 30, 2010 and 2009.
                                 
    Three Months Ended     Nine Months Ended  
(Unaudited)   September 30,     September 30,  
(amounts in thousands, except per share data)   2010     2009     2010     2009  
GAAP results:
                               
Total revenues
  $ 303,993     $ 64,946     $ 780,407     $ 182,275  
Net income
  $ 75,163     $ 6,685     $ 237,996     $ 11,917  
Net income per diluted share
  $ 1.15     $ 0.11     $ 3.65     $ 0.20  
 
                               
Adjusted results:
                               
Total revenues (1)
  $ 107,553     $ 64,946     $ 583,967     $ 182,275  
Net income
  $ 15,823     $ 9,008     $ 183,089     $ 17,733  
Net income per diluted share
  $ 0.24     $ 0.15     $ 2.81     $ 0.29  
The following tables reconcile reported results to net income adjusted for after-tax items for the three and nine months ended September 30, 2010 and 2009.
                                 
    Three months ended     Nine months ended  
(Unaudited)   September 30,     September 30,  
(in millions, except per share amounts)   2010     2009     2010     2009  
Net income
  $ 75.2     $ 6.7     $ 238.0     $ 11.9  
Adjusted to add (deduct):
                               
Change in revenue recognition (1)
    (101.0 )             (101.0 )        
Antitrust litigation settlement (2)
            0.8               1.7  
Share-based compensation
    2.5       2.0       7.7       5.2  
Income tax effect
    39.2       (0.5 )     38.4       (1.0 )
 
                       
Adjusted net income
  $ 15.8     $ 9.0     $ 183.1     $ 17.7  
 
                       
 
                               
Adjusted net income per diluted share
  $ 0.24     $ 0.15     $ 2.81     $ 0.29  
Please refer to the attached footnotes on page 10 for a more detailed description of adjusted items.

 

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Impax Laboratories, Inc.
Non-GAAP Financial Measures
The following tables reconcile reported results to adjusted EBITDA for the three and nine months ended September 30, 2010 and 2009.
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(Unaudited; amounts in millions)   2010     2009     2010     2009  
Net income
  $ 75.2     $ 6.7     $ 238.0     $ 11.9  
Adjusted to add (deduct):
                               
Other (income) expense, net
    0.0       0.0       0.1       (0.1 )
Interest income
    (0.4 )     (0.2 )     (0.7 )     (0.6 )
Interest expense
    0.0       0.2       0.1       0.7  
Depreciation and amortization
    3.0       2.6       9.1       8.2  
Income taxes
    48.5       3.5       146.1       6.4  
Noncontrolling interest
    (0.0 )     (0.0 )     (0.0 )     (0.1 )
 
                       
EBITDA
    127.2       12.8       392.7       26.4  
 
                       
 
                               
Adjusted to add (deduct):
                               
Change in revenue recognition (1)
    (101.0 )             (101.0 )        
Antitrust litigation settlement (2)
            0.8               1.7  
Share-based compensation
    2.5       2.0       7.7       5.2  
 
                       
Adjusted EBITDA
  $ 27.8     $ 15.6     $ 299.4     $ 33.3  
 
                       
(1) Material Modification to Teva Agreement
In July 2010, the Company entered into a material modification of its Strategic Alliance Agreement with Teva, and as a result the Company will apply the revised accounting standards of FASB ASC 605-25 Multiple Element Arrangements (“ASC 605-25”) which became effective for agreements entered into or materially modified on or after June 15, 2010, to its recognition of revenue under the Teva Agreement. The Company applied the accounting principles of ASC 605-25 on a prospective basis beginning in the quarter ended September 30, 2010. For the three months and nine months ended September 30, 2010, the application of ASC 605-25 resulted in recognition in the quarter ended September 30, 2010 of previously deferred revenue and related costs, with the effect of increasing RX Partner revenue by $196.4 million and increasing Cost of revenues by $95.4 million. Basic earnings per share increased by approximately $0.98 and $0.99 for the three and nine months ended September 30, 2010, respectively, as a result of the prospective application of ASC 605-25.
(2) Litigation settlement
In January 2010, the Company entered into an agreement to settle a lawsuit related to its previously marketed Lipram UL products. Under the terms of the litigation settlement agreement, the Company agreed to reimburse the plaintiff for certain litigation costs, which was paid by the Company in January 2010. The Company recorded an accrued expense for this payment in the year ended December 31, 2009. In the three and nine months ended September 30, 2009 the Company recorded litigation settlement expense of $0.8 million and $1.7 million, respectively, which included legal and other professional fees incurred by the Company in its defense against the lawsuit.

 

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