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EX-31.1 - EX-31.1 - Aptalis Pharma Incm70832exv31w1.htm
EX-32.1 - EX-32.1 - Aptalis Pharma Incm70832exv32w1.htm
Table of Contents

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
     
o   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the quarterly period ended March 31, 2011
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                      to                     .
Commission File Number 333-153896
APTALIS PHARMA INC.
(Exact Name of Registrant as Specified in Its Charter)
     
Delaware
(State or Other Jurisdiction of Incorporation or
organization)
  74-3249870
(I.R.S. Employer Identification No.)
     
22 Inverness Center Parkway
Suite 310
Birmingham, AL

(Address of Principal Executive Offices)
  35242
(Zip Code)
(205) 991-8085
(Registrant’s telephone number, including area code)
AXCAN INTERMEDIATE HOLDINGS INC.
(Registrant’s Former Name)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes o No o Registrant has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934, but is not required to file such reports under such sections.
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (paragraph 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes o No o (Registrant is not subject to the requirements of Rule 405 of Regulation S-T at this time).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer”, “accelerated filer” and “small reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer o Accelerated filer o  Non-accelerated filer o
(Do not check if a smaller reporting company)
Smaller reporting company o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No o
As of May 13, 2011, there were 100 shares of common stock of the registrant outstanding, all of which were owned by Aptalis MidHoldings Inc.
 
 

 


 

APTALIS PHARMA INC.
INDEX
         
    3  
    4  
    4  
    4  
    5  
    6  
    7  
    8  
    36  
    60  
    60  
    61  
    61  
    61  
    61  
    62  
    63  
 EX-3.1
 EX-31.1
 EX-31.2
 EX-32.1
 EX-32.2

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Forward-Looking Statements
     This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the U.S. federal securities laws. Statements other than statements of historical facts including, without limitation, statements regarding our future financial position, business strategy, budgets, projected costs and plans, future industry growth and objectives of management for future operations, are forward-looking statements. In addition, forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “intend,” “estimate,” “project,” “forecast,” “anticipate,” “believe” or “continue” or the negative thereof or variations thereon or similar terminology.
     Although we believe that the expectations reflected in these forward-looking statements are reasonable, we can give no assurance that such expectations will prove to have been correct. Certain of the important factors that could cause actual results to differ materially from our expectations, or “cautionary statements,” include, but are not limited to, those discussed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 2 of Part I of this Quarterly Report, “Risk Factors” in Item 1A of Part II of this Quarterly Report, as well as elsewhere in this Quarterly Report on Form 10-Q.
     We caution you not to place undue reliance on any forward-looking statements and we do not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events. All subsequent written and oral forward-looking statements attributable to us, or persons acting on our behalf, are expressly qualified in their entirety by the cautionary statements.

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PART I. FINANCIAL INFORMATION
Item 1   Financial Statements
APTALIS PHARMA INC.
Condensed Consolidated Balance Sheets
(in thousands of U.S. dollars, except share related data)
                 
    March 31,     September 30,  
    2011     2010  
    (unaudited)     (audited)  
    $     $  
Assets
               
Current assets
               
Cash and cash equivalents
    87,330       161,503  
Accounts receivable, net
    75,717       32,379  
Accounts receivable from the parent company (Note 18)
    526       487  
Income taxes receivable
    3,672       2,906  
Inventories, net (Note 7)
    63,450       23,866  
Prepaid expenses and deposits
    5,620       3,277  
Deferred income taxes, net (Note 13)
    6,107       2,331  
 
Total current assets
    242,422       226,749  
Property, plant and equipment, net (Note 8)
    90,268       35,777  
Intangible assets, net (Note 9)
    731,013       347,962  
Goodwill, net (Note 9)
    181,718       73,540  
Deferred debt issue expenses, net of accumulated amortization of $5,236 ($14,136 as at September 30, 2010) (Note 11)
    32,236       20,443  
Deferred income taxes, net (Note 13)
    14,406       8,706  
 
Total assets
    1,292,063       713,177  
 
Liabilities
               
Current liabilities
               
Accounts payable and accrued liabilities
    131,762       94,673  
Income taxes payable (Note 13)
    3,275       3,446  
Installments on long-term debt (Note 11)
    8,918       13,163  
Deferred income taxes (Note 13)
    620       47  
 
Total current liabilities
    144,575       111,329  
Long-term debt (Note 11)
    972,170       581,312  
Other long-term liabilities
    11,252       10,028  
Employees severance indemnities (Note 12)
    5,080        
Deferred income taxes (Note 13)
    95,501       31,540  
 
Total liabilities
    1,228,578       734,209  
 
 
               
Shareholders’ Equity (Deficiency)
               
Capital Stock (Note 14)
               
Common shares, par value $0.001; 100 shares authorized: 100 issued and outstanding as at March 31, 2011, and September 30, 2010
    1       1  
Deficit
    (538,400 )     (468,152 )
9.05% Note receivable from the parent company (Note 18)
    (133,154 )     (133,154 )
Additional paid-in capital
    757,689       614,113  
Accumulated other comprehensive loss
    (22,651 )     (33,840 )
 
Total shareholders’ equity (deficiency)
    63,485       (21,032 )
 
Total liabilities and shareholders’ equity (deficiency)
    1,292,063       713,177  
 
The accompanying notes are an integral part of the condensed consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
On behalf of the Board,
     
 
Director   Director

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APTALIS PHARMA INC.
Condensed Consolidated Statements of Operations
(in thousands of U.S. dollars)
(unaudited)
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
    $     $     $     $  
Net product sales
    109,774       94,365       195,712       204,497  
Development fees
    599             599        
Royalties
    987             987        
 
Total revenue
    111,360       94,365       197,298       204,497  
 
Cost of goods sold (a)
    31,853       68,150       49,276       94,778  
Selling and administrative expenses (a) (Note 12)
    39,044       28,406       64,215       60,645  
Management fees (Note 18)
    730       1,000       1,568       1,855  
Research and development expenses (a)
    10,983       7,683       17,938       16,109  
Other research and development expenses attributable to development fees (a)
    855             855        
Depreciation and amortization
    18,453       13,999       32,026       30,692  
Loss on disposal of product line (Note 6)
    7,365             7,365        
Transaction, restructuring and integration costs (Notes 4 and 5)
    19,249             22,297        
Impairment of intangible assets and goodwill (Note 9)
          107,158             107,158  
 
Total operating expenses
    128,532       226,396       195,540       311,237  
 
Operating income (loss)
    (17,172 )     (132,031 )     1,758       (106,740 )
 
Financial expenses (Note 12)
    30,145       16,385       46,374       32,582  
Loss on extinguishment of debt (Note 11)
    28,311             28,311        
Interest income
    (123 )     (159 )     (315 )     (307 )
Other income
          (7,700 )           (7,700 )
Loss on foreign currencies
    633       1,408       876       1,393  
 
Total other expenses
    58,966       9,934       75,246       25,968  
 
Loss before income taxes
    (76,138 )     (141,965 )     (73,488 )     (132,708 )
Income taxes expense (benefit) (Note 13)
    (4,469 )     21,795       (3,265 )     21,606  
 
Net loss
    (71,669 )     (163,760 )     (70,223 )     (154,314 )
 
 
(a)   Excluding depreciation and amortization
The accompanying notes are an integral part of the condensed consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.

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APTALIS PHARMA INC.
Condensed Consolidated Shareholders’ Equity (Deficiency) and Comprehensive Income (Loss)
(in thousands of U.S. dollars, except share related data)
(unaudited)
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
 
                               
Common shares (number)
                               
Balance, beginning and end of period
    100       100       100       100  
 
 
  $       $       $       $    
 
                               
Common shares
                               
Balance, beginning and end of period
    1       1       1       1  
 
 
                               
Deficit
                               
Balance, beginning of period
    (466,706 )     (288,340 )     (468,152 )     (297,658 )
Dividends paid
    (25 )           (25 )     (128 )
Net loss
    (71,669 )     (163,760 )     (70,223 )     (154,314 )
 
Balance, end of period
    (538,400 )     (452,100 )     (538,400 )     (452,100 )
 
 
                               
Additional paid-in capital
                               
Balance, beginning of period
    613,492       619,195       614,113       619,053  
Capital contribution
    140,000             140,000        
Stock-based compensation expense (recovery)
    5,272       (2,367 )     5,763       (891 )
Stock-based compensation plan redemptions
    (35 )     (57 )     (84 )     (328 )
Provision on interest receivable from the parent company
    (2,971 )     (2,971 )     (6,008 )     (6,008 )
Interest income from the parent company, net of taxes of ($1,040, $1,040 $2,103, $2,103)
    1,931       1,931       3,905       3,905  
 
Balance, end of period
    757,689       615,731       757,689       615,731  
 
 
                               
9.05% Note receivable from the parent company
                               
Balance, beginning and end of period
    (133,154 )     (133,154 )     (133,154 )     (133,154 )
 
 
                               
Accumulated other comprehensive loss
                               
Balance, beginning of period
    (35,869 )     (27,308 )     (33,840 )     (24,478 )
Hedging contracts fair value adjustments, net of taxes of (nil, ($38), nil, $4)
          71             (7 )
Foreign currency translation adjustments
    13,218       (7,371 )     11,189       (10,123 )
 
Balance, end of period
    (22,651 )     (34,608 )     (22,651 )     (34,608 )
 
Total shareholders’ equity (deficiency)
    63,485       (4,130 )     63,485       (4,130 )
 
 
                               
Comprehensive income (loss)
                               
Other comprehensive income (loss)
    13,218       (7,300 )     11,189       (10,130 )
Net loss
    (71,669 )     (163,760 )     (70,223 )     (154,314 )
 
Total comprehensive loss
    (58,451 )     (171,060 )     (59,034 )     (164,444 )
 
 
                               
Accumulated other comprehensive loss
                               
Amounts related to foreign currency translation adjustments
    (22,651 )     (34,608 )     (22,651 )     (34,608 )
Amounts related to hedging contracts fair value adjustments
                       
 
Accumulated other comprehensive loss
    (22,651 )     (34,608 )     (22,651 )     (34,608 )
 
The accompanying notes are an integral part of the condensed consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.

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APTALIS PHARMA INC.
Condensed Consolidated Cash Flows
(in thousands of U.S. dollars)
(unaudited)
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
    $     $     $     $  
 
                               
Cash flows from operating activities
                               
Net loss
    (71,669 )     (163,760 )     (70,223 )     (154,314 )
Adjustments to reconcile net income to cash flows from operating activities
                               
Non-cash financial expenses
    15,281       1,746       17,035       3,508  
Inventory stepped-up value expensed
    4,382             4,382        
Depreciation and amortization
    18,453       13,999       32,026       30,692  
Stock-based compensation expense (recovery)
    5,272       (2,367 )     5,763       (891 )
Loss on disposal of product line and write-down of assets
    7,365       56       7,395       81  
Impairment of intangible assets and goodwill (Note 9)
          107,158             107,158  
Non-cash loss (gain) on foreign exchange
    (733 )     522       (694 )     43  
Change in fair value of derivatives
          (105 )           (621 )
Deferred income taxes
    (5,633 )     20,436       (7,234 )     19,066  
Other non-cash adjustments related to unapproved PEPs (Note 2)
    (3,706 )     53,407       (3,706 )     53,407  
Changes in working capital items
                               
Accounts receivable
    (3,508 )     17,661       (16,116 )     2,760  
Accounts receivable from the parent company
    (1 )     (74 )     (39 )     (74 )
Income taxes receivable
    3,824       (63 )     1,887       1,671  
Inventories
    2,978       (3,065 )     4,105       (7,933 )
Prepaid expenses and deposits
    1,011       466       1,579       202  
Accounts payable and accrued liabilities
    (14,595 )     (15,822 )     (16,509 )     4,292  
Income taxes payable
    (3,639 )     910       (873 )     572  
 
Net cash provided by (used in) operating activities
    (44,918 )     31,105       (41,222 )     59,619  
 
 
                               
Cash flows from investing activities
                               
Acquisition, net of cash acquired (Note 4)
    (525,667 )           (525,667 )      
Disposal of intangible assets
    500             500        
Acquisition of property, plant and equipment
    (2,371 )     (2,333 )     (3,506 )     (3,462 )
 
Net cash used in investing activities
    (527,538 )     (2,333 )     (528,673 )     (3,462 )
 
 
                               
Cash flows from financing activities
                               
Issuance of long-term debt
    746,250             746,250        
Repayment of long-term debt
    (355,887 )           (369,050 )     (20,865 )
Deferred debt issue expenses
    (22,963 )           (22,963 )      
Stock-based compensation plan redemptions
    (35 )     (57 )     (84 )     (328 )
Capital contribution
    140,000             140,000        
Dividends paid
    (25 )           (25 )     (128 )
 
Net cash provided by (used in) financing activities
    507,340       (57 )     494,128       (21,321 )
 
Foreign exchange loss (gain) on cash held in foreign currencies
    1,710       (692 )     1,594       (857 )
 
 
                               
Net increase (decrease) in cash and cash equivalents
    (63,406 )     28,023       (74,173 )     33,979  
Cash and cash equivalents, beginning of period
    150,736       132,391       161,503       126,435  
 
Cash and cash equivalents, end of period
    87,330       160,414       87,330       160,414  
 
The accompanying notes are an integral part of the condensed consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
1. Governing Statutes, Description of Business and Basis of Presentation
On May 4, 2011, Axcan Intermediate Holdings Inc announced that it has changed its name to Aptalis Pharma Inc., a corporation incorporated on November 28, 2007, under the General Corporation Law of the State of Delaware and its subsidiaries (together the “Company”), commenced active operations with the purchase, through a wholly-owned indirect subsidiary on February 25, 2008, of all of the outstanding common shares of Axcan Pharma Inc. at a price of $23.35 per share (“the Acquisition”), a company incorporated under the Canada Business Corporation Act. The Company provides innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. The Company has manufacturing and commercial operations in the United States, the European Union and Canada. The Company also formulates and clinically develops, enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegration tablet (ODT) formulations.
On February 11, 2011, the Company completed the acquisition of Eurand N.V. (“Eurand”) through a wholly owned indirect subsidiary pursuant to a Share Purchase Agreement dated November 30, 2010 (as amended) resulting in Eurand becoming an indirect subsidiary of the Company. Eurand is a specialty pharmaceutical company that is engaged in the development, manufacturing and commercialization of enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies.
As described in Note 4, the Eurand transaction has been accounted for in accordance with the acquisition method of accounting for business combinations. Accordingly, the Company’s condensed consolidated financial statements reflect the assets, liabilities and results of operations of Eurand from the date of acquisition.
The accompanying unaudited condensed consolidated financial statements are presented in U.S. dollars, the reporting currency, and prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial statements and with the requirements of the Securities and Exchange Commission for reporting on Form 10Q. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. The interim financial statements and related notes should be read in conjunction with the Company’s audited financial statements for the fiscal year ended September 30, 2010. When necessary, the financial statements include amounts based on informed estimates and best judgment of management. The results of operations for the interim periods reported are not necessarily indicative of results to be expected for the year. In Management’s opinion, the financial statements reflect all adjustments (including those that are normal and recurring) that are necessary for a fair presentation of the results of operation for the periods shown. Certain prior period amounts have been reclassified to conform to the current period presentation. All intercompany transactions and balances have been eliminated on consolidation.
2. Significant Accounting Policies
The following policies are interim updates to those discussed in Note 2 to the Company’s audited financial statements for the fiscal year ended September 30, 2010.
Revenue recognition
Revenue is recognized when the product is shipped to the Company’s customers, provided the Company has not retained any significant risks of ownership or future obligations with respect to the product shipped. Provisions for sales discounts and estimates for chargebacks, managed care and Medicaid rebates, product returns and distribution service agreement fees are recorded as a reduction of product sales revenues at the time such revenues are recognized. These revenue reductions are established by the Company at the time of sale, based on historical experience adjusted to reflect known changes in the factors that impact such reserves. In certain circumstances, returns of products are allowed under the Company’s policy and provisions are maintained accordingly. These revenue reductions are generally reflected as an addition to accrued liabilities. Amounts received from customers as prepayments for products to be shipped in the future are reported as deferred revenue.
The Company presents, on a net basis, taxes collected from customers and remitted to governmental authorities; that is, they are excluded from revenues.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
ULTRASE and VIOKASE, the Company’s pancreatic enzyme products (“PEPs”) have historically accounted for approximately a 19% of the Company’s net sales in the three years ended September 30, 2009. Prior to April 28, 2010, products that were marketed in the U.S. to treat exocrine pancreatic insufficiency had been available before the passage of the Federal Food, Drug, and Cosmetic Act, or FDCA, in 1938 and, consequently, there were marketed PEPs that had not been approved under the NDA process by the FDA. In 1995, the FDA issued a final rule requiring that these PEPs be marketed by prescription only, and, in April 2004, the FDA mandated that all manufacturers of exocrine pancreatic insufficiency drug products file an NDA and receive approval for their products by April 2008 or be subject to regulatory action. In October 2007, the FDA published a notice in the Federal Register extending the deadline within which to obtain marketing approval for exocrine pancreatic insufficiency drug products to April 28, 2010, for those companies that were (a) marketing unapproved pancreatic enzyme products as at April 28, 2004; (b) submitted NDAs on or before April 28, 2009; and (c) that continue diligent pursuit of regulatory approval. The FDA has required all manufacturers with unapproved NDAs to cease distribution of unapproved products after April 28, 2010, until such time that NDA approval is granted. After this date, the unapproved products were still available on pharmacy shelves for a short time until stock is depleted. The FDA has stated that it will continue to review NDAs that have been submitted by manufacturers of unapproved PEPs, and will approve additional PEPs even after the April 28, 2010 deadline has passed, if they meet the required safety, effectiveness and product quality standards. The Company completed the submission for ULTRASE MT in the fourth quarter of fiscal year 2008. The submission of the Company’s rolling NDA for VIOKASE was completed in the first quarter of fiscal year 2010.
ULTRASE MT and VIOKASE did not receive NDA approval by the April 28, 2010 deadline and the Company has ceased distributing the two products after that date, in compliance with the FDA guideline. The Company recorded an additional $23,453,000 sales deductions reserve in its fiscal year ended September 30, 2010. This reserve is for product returns and other sales deductions as an estimate of Company’s liability for ULTRASE MT and VIOKASE that may be returned by the original purchaser under the Company DSAs or applicable return policies. The cease distribution order issued by the FDA was not considered as a product recall. As at March 31, 2011, the remaining reserve was $5,293,000 and was based on management estimates of ULTRASE MT and VIOKASE inventory in the distribution channel, assumptions on related expiration dates of this inventory as well as estimated erosion of ULTRASE MT and VIOKASE demand, based on competition from approved PEPs and the resulting estimated sell-through of ULTRASE MT and VIOKASE, actual return activity and other factors. In future periods, the Company will monitor and review the estimates and will prospectively record changes to the reserve.
On November 28, 2010, the FDA issued complete response letters regarding the NDAs for ULTRASE MT and VIOKASE. The letters require that unresolved deficiencies raised with respect to the manufacturing and control processes at the manufacturer of the active ingredient for both ULTRASE MT and VIOKASE be addressed before approval can be granted. The letters also require that deficiencies identified in an FDA inspection of such manufacturer must be resolved before the NDAs can be approved. The Company is in ongoing discussions with the FDA and continues to work with the manufacturer of the active pharmaceutical ingredient to address the remaining open issues identified by the FDA, as soon as possible.
3. Recently Issued Accounting Standards
In December 2010, the FASB amended guidance on disclosure of supplementary pro forma information for business combinations and clarifies that when presenting comparative financial statements, a public entity should disclose revenue and earnings of the combined entity as though the current period business combinations had occurred as of the beginning of the comparable prior annual reporting period only. The amendment also expands the supplemental pro forma disclosures to include a description of the nature and amount of material, nonrecurring pro forma adjustments directly attributable to the business combination included in the reported pro forma revenue and earnings. This guidance is effective prospectively for business combinations entered into in fiscal years beginning on or after December 15, 2010, with early adoption permitted. The Company will apply this guidance for future acquisitions on its condensed consolidated financial statements.
In December 2010, the FASB issued guidance that modifies the Step 1 of the goodwill impairment test for reporting units with zero or negative carrying amounts. For those reporting units, an entity is required to perform Step 2 of the goodwill impairment test if qualitative factors indicate that it is more likely than not that a goodwill impairment exists. This guidance is effective for fiscal years and interim periods within those years, beginning after December 15, 2010. Early adoption is not permitted. The Company is currently evaluating the impact of the adoption of this guidance on its condensed consolidated financial statements.
In December 2010, the FASB issued guidance that clarified the recognition and classification of annual fees mandated by the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act in the income statements of pharmaceutical manufacturers. The guidance requires that the liability for the fee should be estimated and recorded in full upon the first qualifying sale with a corresponding deferred cost that is amortized to expense using a straight-line method of allocation unless another method better allocates the fee over the calendar year that it is payable. The annual fee shall be presented as an operating expense. This guidance is effective for calendar years beginning after December 31, 2010, when the fee initially becomes effective. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
In March 2010, the FASB issued guidance related to revenue recognition that applies to arrangements with milestones relating to research or development deliverables. This guidance provides criteria that must be met to recognize consideration that is contingent upon achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. The guidance provides a definition of substantive milestone and should be applied regardless of whether the arrangement includes single or multiple deliverables or units of accounting. This guidance is effective prospectively to milestones achieved in fiscal years, and interim periods within those years, after June 15, 2010, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements.
In March 2010, the FASB amended the existing guidance on stock compensation to clarify that an employee share-based payment award with an exercise price denominated in the currency of a market in which a substantial portion of the entity’s equity securities trades should not be considered to contain a condition that is not a market, performance, or service condition. Therefore, such an award should not be classified as a liability if it otherwise qualifies as equity. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2010. The adoption of this guidance is not expected to have a material impact on the Company’s condensed consolidated financial statements.
In October 2009, the FASB amended the existing guidance on revenue recognition related to accounting for multiple-element arrangements. This amendment addresses how to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting, and how the arrangement consideration should be allocated among the separate units of accounting. This guidance is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, and early adoption is permitted. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements.
In April 2008, the FASB issued guidance that amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset. The intent of this guidance is to improve the consistency between the useful life of a recognized intangible asset determined in accordance with the guidance on intangible assets and the period of expected cash flows used to measure the fair value of the asset determined in accordance with the amended guidance for business combinations and other authoritative guidance. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Early adoption is prohibited. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements.
In December 2007, the FASB issued guidance related to collaborative arrangements. The guidance defines collaborative arrangements and establishes reporting requirements for transactions between participants in a collaborative arrangement and between participants in the arrangement and third parties. The guidance also establishes the appropriate income statement presentation and classification for joint operating activities and payments between participants, as well as the sufficiency of the disclosures related to these arrangements. This guidance is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2008, and shall be retrospectively to all prior periods presented for all collaborative arrangements existing as of the effective date. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements.
4. Acquisition of Eurand N.V. (“Eurand”)
Description of the transaction
On February 11, 2011 or the Acquisition Date, Axcan Holdings Inc. (“Axcan Holdings”), the Company’s indirect parent, and Axcan Pharma Holding B.V. (“Axcan AcquisitionCo”), an indirect subsidiary of the Company, pursuant to a Share Purchase Agreement dated November 30, 2010 (as amended) acquired 95.6% (99.1% after giving effect to the additional shares that are guaranteed to be delivered under a notice of guaranteed delivery) of the outstanding shares of Eurand N.V. (“Eurand”) for a purchase price of $12.00 per share in cash resulting in total consideration of approximately $589,555,000 for 100% of such shares. The Company acquired 100% of the outstanding shares of Eurand by March 31, 2011. As a result of the acquisition, Eurand has become an indirect subsidiary. In addition, Axcan AcquisitionCo and other direct and indirect subsidiaries of the Company acquired from Eurand substantially all of Eurand’s assets, including the capital stock of Eurand’s direct and indirect U.S. and foreign subsidiaries, and transferred the capital stock of former Eurand U.S. subsidiaries to the Company.
Prior to the transaction, Eurand was a specialty pharmaceutical company that developed, manufactured and commercialized enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies. Eurand has had six products approved by the FDA since 2001 and had a pipeline of product candidates in development for itself and its collaboration partners. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles and taste-masking/orally disintegrating tablet (ODT) formulations. Eurand was a global company with facilities in the U.S. and Europe. The acquisition of Eurand will enable the Company to leverage the combination of two leading specialty pharmaceutical players, expand its gastroenterology product portfolio and provide the Company with a proprietary R&D growth engine and technology platforms supported by an extensive patent portfolio to meaningfully diversify its business and expand its geographic and manufacturing footprint.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
 
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Fair value of consideration transferred
The table below details the consideration transferred to acquire Eurand:
                         
    Conversion             Form of  
    Calculation     Fair Value     Consideration  
            $          
Eurand common stock outstanding as of acquisition date
    48,359,433       580,313     Cash
Mutiplied by cash consideration per common share outstanding
    12.00                  
Eurand stock options canceled for a cash payment(a)
            9,242     Cash
 
Total fair value of consideration transferred
            589,555          
 
(a)   Each Eurand stock option, whether or not vested and exercisable on the acquisition date, was canceled for a cash payment equal to the excess of the per share value of the acquisition consideration over the per share exercise price of the Eurand stock option.
The aggregate equity purchase price of $589,555,000 plus acquisition costs (including related fees and expenses) were funded by cash equity contributions amounting to $140,000,000 from affiliates of TPG Capital L.P. and certain co-investors made through Aptalis Holdings Inc., the proceeds from the Senior Secured Term Loan Facility (as defined below) under the Company’s amended and restated credit agreement and related security and other agreements and cash on hand from the Company and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147,000,000 (the “Senior Secured Revolving Credit Facility”) and (ii) a $750,000,000 senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”). The Senior Secured Revolving Credit Facility is comprised of $115,000,000 of existing revolving credit commitments that were extended or issued on February 11, 2011, (the “ Extended Commitments “) and $32,000,000 of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility.
The Company borrowed $500,000,000 of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of the Company and Eurand, were also used to repay the outstanding term loan portion amounting to $125,660,000 of the Company’s existing senior secured credit facilities and to pay related fees and expenses. The remaining amount of $250,000,000 of the Senior Secured Term Loan Facility was used on March 15, 2011 to redeem 100% of the Company’s existing 9.25% senior secured notes due 2015.
Basis of presentation
The transaction has been accounted for in accordance with the acquisition method of accounting for business combinations under existing U.S. generally accepted accounting principles (“GAAP”). The acquisition method of accounting requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date including acquired in-process research and development assets.
Assets acquired and liabilities assumed
A preliminary purchase price allocation has been made and the recorded amounts are subject to change. The following recognized amounts are provisional and subject to change:
  Amounts and useful lives for identifiable intangible assets and property, plant and equipment, pending the finalization of valuation efforts;
  Amounts for income tax assets and liabilities, pending finalization of estimates and assumptions in respect of certain tax aspects of the transaction, revision to fair value of acquired assets and liabilities, and the filing of Eurand’s pre-acquisition tax returns; and
  The allocation of goodwill among reporting units.
The Company will finalize the purchase price allocation as it obtains the information necessary to complete the measurement process. Any changes resulting from facts and circumstances that existed as of the acquisition date may result in retrospective adjustments to the provisional amounts recognized at the acquisition date. The Company expects to finalize the purchase price allocation no later than one year from the acquisition date.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
 
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Resulting from the preliminary purchase price allocation, the following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date.
                         
                    Amounts  
            Step-up to     recognized as of  
    Book value     fair value     acquisition date  
    $     $     $  
Cash and cash equivalents
    63,888             63,888  
Accounts receivable (a)
    22,662             22,662  
Inventories (b)
    25,465       18,727       44,192  
Other current assets (c)
    6,552             6,552  
Property, plant and equipment (d)
    44,652       10,874       55,526  
Identifiable intangible assets (d)
    7,053       406,876       413,929  
Current liabilities (e)
    (51,960 )           (51,960 )
Long-term debt, including current portion
    (3,394 )           (3,394 )
Deferred income taxes liabilities, net (f)
    (237 )     (61,012 )     (61,249 )
Other non-current liabilities
    (8,489 )     2,278       (6,211 )
 
Total identifiable net asssets
    106,192       377,743       483,935  
Goodwill (g)
    37,540       68,977       106,517  
 
Net assets acquired
    143,732       446,720       590,452  
 
Effective settlement of pre-existing relationships (h)
    (897 )           (897 )
 
Total fair value of consideration transferred
                    589,555  
 
(a)   As of acquisition date, the fair value of accounts receivable acquired approximated book value. The gross contractual amount receivable was $23,118,000 of which $456,000 was not expected to be collected.
 
(b)   Reflects the adjustment to step-up the carrying value of inventory acquired by $18,727,000 to estimated fair value as of February 11, 2011. The stepped-up value is recorded as a charge to cost of goods sold as acquired inventory is sold.
 
(c)   Includes prepaid assets and income tax receivable.
 
(d)   The amounts recorded for the major components of acquired identifiable intangible assets are as follows:
                 
    Amounts     Weighted  
    recognized as of     average useful  
    acquisition date     lives (years)  
    $          
Trademarks, trademark licenses, manufacturing rights and other intangible assets with a finite life
    413,929       17.04  
 
Total identifiable intangible assets
    413,929       17.04  
 
 
    In addition, the estimated aggregate amortization expense for the five succeeding years will be $25,599,000 annually.
 
(e)   Includes accounts payable, accrued liabilities and income taxes payable.
 
(f)   Comprises of current deferred tax assets $823,000, non current deferred tax assets $15,703,000, current deferred tax liabilities $3,000 and non current deferred tax liabilities $77,772,000.
 
(g)   The excess of purchase price over the fair value amounts assigned to the assets acquired and liabilities assumed represents the goodwill amount resulting from the acquisition. The goodwill recorded as part of the acquisition is largely attributable to synergies expected to result from combining the operations of Eurand and the Company and intangible assets that do not qualify for separate recognition. The Company does not expect any portion of this goodwill to be deductible for tax purposes. The allocation of goodwill among reporting units is not complete, pending finalization of the Company’s internal reporting structure and composition of its post-acquisition operating segments and reporting units.
 
(h)   The Company had entered into an exclusive development license and supply agreement with Eurand. No gain or loss was recognized in conjunction with the effective settlement of the contractual relationship between the Company and Eurand as a result of this acquisition.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
 
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Transaction related costs
During the six-month period ended March 31, 2011, the Company has expensed $11,292,000 (an additional $1,070,000 was expensed in the fiscal year ended September 30, 2010) of costs relating to legal, financial, valuation and accounting advisory services performed in connection with effecting the transaction with Eurand, which are included in transaction and restructuring costs in the accompanying Statement of Condensed Interim Consolidated Operations.
Actual and proforma information
The revenues derived from the Eurand entities for the period from the Acquisition Date to March 31, 2011 were $25,752,000 and loss before income taxes was $670,000, excluding the effects of the non-recurring acquisition accounting adjustments described above.
The following table presents unaudited pro forma consolidated results of operations as if the acquisition of Eurand had occurred as of October 1, 2009:
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
    $     $     $     $  
Total revenue
    131,530       123,478       261,397       261,358  
Loss before income taxes
    (27,059 )     (108,865 )     (27,459 )     (117,070 )
 
Net loss
    (24,914 )     (130,002 )     (26,433 )     (134,781 )
 
The pro forma consolidated results of operations were prepared using the acquisition method of accounting and are based on the historical financial information of the Company and Eurand. The pro forma information does not reflect any synergies and other benefits that the Company may achieve as a result of the acquisition, or the costs necessary to achieve these synergies. In addition, the pro forma information does not reflect the costs to integrate the operations of the Company and Eurand.
The pro forma information is not necessarily indicative of what the Company’s consolidated results of operations actually would have been had the transaction been completed on October 1, 2009. In addition, the pro forma information does not purport to project the future results of operations of the Company. The pro forma information reflects primarily the following pro forma adjustments:
  elimination of product sales and royalties between Eurand and the Company, an elimination of the Company’s cost of sales for Eurand-sourced inventories, and the elimination of certain PEP-related charges stemming from intercompany transactions;
 
  elimination of Eurand’s historical intangible asset amortization expense;
 
  additional amortization expense related to the fair value of identifiable intangible assets acquired;
 
  additional depreciation expense related to the fair value adjustment to property, plant and equipment acquired;
 
  elimination of interest expense and amortization of deferred financing costs related to the Company’s term loan under the legacy senior secured credit facilities and 9.25% senior secured notes due 2015 that were repaid as part of the acquisition transaction;
 
  additional interest expense and amortization of deferred financing costs associated with financing obtained under the Amended and Restated Senior Secured Credit Facilities obtained by the Company in connection with the acquisition transaction;
 
  reduction of interest income associated with cash and cash equivalents that were used to partially fund the acquisition;
 
  elimination of acquisition-related costs and acquisition-related restructuring charges;
 
  elimination of $4,382,000 of the acquisition accounting adjustment on Eurand’s inventory that was sold subsequent to the Aquisition Date, which will not have a continuing impact on the Company’s operations.
The pro forma effective tax rate differs from the statutory rate due to the relatively large impact of actual permanent differences on relatively small pro forma income before tax, valuation allowances on deferred tax assets in certain jurisdictions, and the expected impact of foreign withholding taxes upon repatriation of foreign earnings.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
 
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
5. Restructuring and Integration
Acquisition related cost-rationalization and integration initiatives
The Company has initiated restructuring measures in conjunction with the integration of the operations of Eurand. These measures are intended to capture synergies and generate cost savings across the Company.
Restructuring actions taken thus far include workforce reductions across the Company and other organizational changes. These reductions primarily come from the elimination of redundancies and consolidation of staff in the sales and marketing, manufacturing, research and development, and general and administrative functions, as well as from the planned closure of Eurand’s manufacturing facility in Nogent-Oise, France.
During the quarter ended March 31, 2011, the Company recorded a restructuring expense in the amount of $5,025,000 related to planned employee termination costs. Employee termination costs are generally recorded when the actions are probable and estimable and include accrued severance benefits and health insurance continuation, many of which may be paid out during periods after termination.
The following table summarizes restructuring liability activity related to the Eurand acquisition during the quarter ended March 31, 2011:
                         
    Liability             Balance  
    Established     Payments     March 31,2011  
    $     $     $  
Severance and related benefits
    5,025       (132 )     4,893  
 
The Company estimates to incur additional costs between $17,172,000 and $21,346,000 in connection with planned employee termination costs. The restructuring actions taken thus far are expected to be substantially completed by the end of 2012.
Through March 31, 2011, the Company has incurred integration costs of $5,980,000 representing certain external, incremental costs directly related to integrating the acquired business and primarily include expenditures for consulting and systems integration. Restucturing and integration costs are included in transaction and restructuring costs in the accompanying Statement of Condensed Consolidated Operations.
6. Disposal of the PHOTOFRIN/PHOTOBARR Product Line
On March 28, 2011, The Company entered into a definitive agreement with Pinnacle Biologics, Inc., which acquired all global assets and rights related to PHOTOFRIN/PHOTOBARR, including inventory, for non-contingent payments amounting to $4,252,000. In addition to the non-contingent payments, additional payments shall be made to the Company after the achievement of certain milestones events. In addition, the Company will be paid royalties on annual net sales of PHOTOFRIN/PHOTOBARR.
During the quarter ended March 31, 2011, The Company recorded a loss of $7,365,000 as a result of the disposal of the PHOTOFRIN/PHOTOBARR product line. Consideration for additional contingent payments to be made to the Company shall be recorded as a gain in the period in which they are received.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
 
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
7. Inventories
                 
    March 31,     September 30,  
    2011     2010  
    $     $  
Raw material and packaging material, net of reserve for obsolescence of $2,498 (nil as at September 30, 2010)
    18,065       10,316  
Work in progress, net of reserve for obsolescence of $927 (nil as at September 30, 2010)
    6,896       595  
Finished goods, net of reserve for obsolescence of $1,122 ($758 as at September 30, 2010)
    38,489       12,955  
 
 
    63,450       23,866  
 
As disclosed in Note 2, the Company’s PEPs did not obtain regulatory approval by the April 28, 2010 deadline established by the FDA. As a result, a charge of $44,883,000 was recorded during the fiscal year ended September 30, 2010, to cost of goods sold to reduce inventories to their net realizable value and for estimated loss for purchase and other materials and supply commitments related to ULTRASE MT and VIOKASE products.
Include the adjustment to step-up the carrying value of inventory acquired by $18,727,000 to estimated fair value as of February 11, 2011, less a charge to cost of goods sold as acquired inventory is sold amounting to $4,382,000.
8. Property, Plant and Equipment
                         
    March 31, 2011  
            Accumulated        
    Cost     depreciation     Net  
    $     $     $  
Land
    4,865             4,865  
Buildings
    46,542       5,580       40,962  
Furniture and equipment
    37,303       5,206       32,097  
Automotive equipment
    30       1       29  
Computer equipment and software
    24,016       12,322       11,694  
Leasehold and building improvements
    1,190       569       621  
 
 
    113,946       23,678       90,268  
 
                         
    September 30, 2010  
            Accumulated        
    Cost     depreciation     Net  
    $     $     $  
Land
    2,240             2,240  
Buildings
    23,252       4,490       18,762  
Furniture and equipment
    8,534       3,515       5,019  
Computer equipment and software
    18,419       9,588       8,831  
Leasehold and building improvements
    1,220       295       925  
 
 
    53,665       17,888       35,777  
 

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
 
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
9. Goodwill and Intangible Assets
The following table reflects the changes in carrying amount of goodwill from September 30, 2010 to March 31, 2011:
                 
    March 31,     September 30,  
    2011     2010  
    $     $  
Balance, beginning of period
    73,540       165,823  
Acquisition of Eurand
    106,517        
Impairment
          (91,400 )
Foreign exchange
    1,661       (883 )
 
Balance, end of period
    181,718       73,540  
 
As disclosed in Note 4, the amount recorded as goodwill for the acquisition of Eurand is provisional and subject to the completion of the allocation of the consideration transferred to the assets acquired and liabilities assumed.
The following table reflects the changes in the carrying amount of intangible assets:
Trademarks, trademark licenses, manufacturing rights and other intangible assets with a finite life
                         
    March 31, 2011  
            Accumulated        
    Cost     amortization     Net  
    $     $     $  
Balance, as at September 30, 2010
    459,207       111,245       347,962  
Acquisition of Eurand
    413,929             413,929  
Assets written-off on disposal of Photofrin/Photobarr
    (11,749 )     (1,503 )     (10,246 )
Amortization
          26,335       (26,335 )
Foreign exchange
    6,483       780       5,703  
 
Balance, as at March 31, 2011
    867,870       136,857       731,013  
 
                         
    September 30, 2010  
            Accumulated        
    Cost     amortization     Net  
    $     $     $  
Balance, as at September 30, 2009
    491,411       70,121       421,290  
Impairment
    (26,400 )     (10,642 )     (15,758 )
Amortization
          52,465       (52,465 )
Foreign exchange
    (5,804 )     (699 )     (5,105 )
 
Balance, as at September 30, 2010
    459,207       111,245       347,962  
 

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APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
 
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
10. Segment Information
Prior to the acquisition of Eurand, the Company operated in one segment, pharmaceutical products. Effective with the acquisition of Eurand, the Management of the Company is reassessing the Company’s internal reporting structure and composition of its operating segments for disclosure in succeeding interim and annual reporting periods.
The Company operates in the following geographic areas:
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
    $     $     $     $  
Total revenue
                               
United States
                               
Domestic sales
    80,078       68,371       138,027       152,147  
Foreign sales
    2,292       1,243       2,562       2,621  
Canada
                               
Domestic sales
    8,099       7,862       18,145       16,729  
Foreign sales
    225             361        
European Union
                               
Domestic sales
    16,430       14,691       31,280       28,715  
Foreign sales
    4,236       2,080       6,923       3,920  
Other
          118             365  
 
 
    111,360       94,365       197,298       204,497  
 
Revenue is attributed to geographic areas based on the country of origin of the sales.
                 
    March 31,     September 30,  
    2011     2010  
    $     $  
Property, plant, equipment and intangible assets
               
Canada
    270,669       299,180  
United States
    52,867       13,906  
European Union
    497,745       70,653  
 
 
    821,281       383,739  
 
                 
    March 31,     September 30,  
    2011     2010  
    $     $  
Goodwill
               
Canada
    61,887       61,887  
United States
    20,931        
European Union
    98,900       11,653  
 
 
    181,718       73,540  
 

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APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
11. Long-term Debt
                 
    March 31,     September 30,  
    2011     2010  
    $     $  
Senior secured term loan of $748,125 as at March 31, 2011, ($0 as at September 30, 2010), bearing interest at a rate per annum equal to an applicable margin plus, at the Company’s option, either (1) a base rate determined by reference to the highest of (a) the prime rate of Banc of America Securities LLC, (b) the federal funds effective rate plus 1/2 of 1.00% and (c) the one-month LIBOR rate plus 1.00% or (2) a LIBOR rate determined by reference to the costs of funds for U.S. dollar deposits for the interest period relevant to such borrowing adjusted for certain additional costs. The applicable margins for borrowings under the Senior Secured Term Loan Facility are 3.00% with respect to base rate borrowings and 4.00% with respect to LIBOR borrowings. In addition, the LIBOR rate and base rate for borrowings under the Senior Secured Term Loan Facility are subject to a floor of 150 basis points and 250 basis points, respectively, secured by substantially all of the present and future assets of the Company, payable in quarterly installments, maturing in February 2017
    744,626        
 
               
Term loans of $0 as at March 31, 2011, ($138,823 as at September 30, 2010), bearing interest at the one-month British Banker Association LIBOR (0.26% as at September 30, 2010), plus the applicable rate based on the consolidated total leverage ratio of the Company and certain of its subsidiaries for the preceding twelve months, secured by substantially all of the present and future assets of the Company, payable in quarterly installments
          135,210  
 
               
Unsecured loan of 2,252 Euros as at March 31, 2011, with a variable interest of 1.6% above Euribor. Euribor interest rate has a cap of 2.5%
    3,194        
 
               
Senior unsecured notes, bearing interest at 12.75% and maturing in March 2016
    233,268       233,094  
 
               
Senior notes bearing interest at 9.25%, redeemed on March 15, 2011
          226,171  
 
 
               
 
    981,088       594,475  
 
               
Installments due within one year
    8,918       13,163  
 
 
               
 
    972,170       581,312  
 
On February 11, 2011, the Company entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147,000,000 (the “Senior Secured Revolving Credit Facility”) and (ii) a $750,000,000 senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”).
The Company borrowed $500,000,000 of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of the Company and Eurand, were used to repay the outstanding term loan portion amounting to $125,660,000 of the Company’s existing senior secured credit facilities. Following the repayment, all unamortized deferred financing fees of $2,653,000 and original issuance discount of $3,188,000 related to the term loan were written off and are included in loss on extinguishment of debt in the accompanying Statement of Condensed Consolidated Operations.
On February 25, 2008, the Company issued $228,000,000 aggregate principal amount of its 9.25% senior secured notes (the “Senior Secured Notes”) due March 1, 2015. The Senior Secured Notes were priced at $0.98737 with a 10% yield to March 1, 2015. On March 15, 2011, $250,000,000 of the Senior Secured Term Loan Facility was drawn to redeem the Company’s Senior Secured Notes at a redemption price of 106.938%. The aggregate redemption amount consisted of $228,000,000 in aggregate principal amount, and $15,819,000 of redemption premium which is included in loss on extinguishment or debt in the accompanying Statement of Condensed Consolidated Operations. Following the redemption all unamortized deferred financing fees of $4,992,000 and original issuance discount of $1,659,000 related to these notes were written off and are included in loss on extinguishment of debt in the accompanying Statement of Condensed Consolidated Operations.

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APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
The Company’s Amended and Restated Senior Secured Credit Facilities totaling $897,000,000 is composed of a Senior Secured Term Loan Facility amounting to $750,000,000 and a Senior Secured Revolving Credit Facility totaling $147,000,000. The Senior Secured Revolving Credit Facility is comprised of $115,000,000 of existing revolving credit commitments that were extended or issued (the “ Extended Commitments”) and $32,000,000 of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility. The Amended and Restated Senior Secured Credit Facilities bear interest at a variable rate available composed of either the Federal Funds Rate or the British Banker Association LIBOR rate, at the option of the Company, plus the applicable rate based on the consolidated total leverage ratio of the Company and certain of its subsidiaries for the preceding twelve months. The principal amount of the Senior Secured Term Loan Facility amortizes in equal quarterly installments in aggregate annual amounts equal to 1% of the original principal amount with payments beginning in fiscal year 2011. The principal amount outstanding of the loans under the Senior Secured Term Loan Facility will be due and payable on February 11, 2017. The principal amount of outstanding loans under the Senior Secured Revolving Facility will be due and payable on February 11, 2016 with respect to Extended Commitments and on February 25, 2014 with respect to Unextended Commitments.
As at March 31, 2011, $750,000,000 of term loans had been issued and no amounts had been drawn during the quarter against the revolving credit facility. The term loans were priced at $0.995, with a yield to maturity of 5.6%. The Amended and Restated Senior Secured Credit Facility requires the Company to meet certain financial covenants, beginning quarter ending June 30, 2011. The maintenance of these financial covenants is solely with respect to the Senior Secured Revolving Credit Facility. The credit agreement governing the Amended and Restated Senior Secured Credit Facility requires the Company to prepay outstanding term loans contingent upon the occurrence of events, subject to certain exceptions, with: (1) 100% of the net cash proceeds of any incurrence of debt other than debt permitted under the Amended and Restated Senior Secured Credit Facility, (2) commencing with the fiscal year ending September 30, 2011, 50% (which percentage will be reduced if the senior secured leverage ratio is less than a specified ratio) of the annual excess cash flow (as defined in the credit agreement governing the Senior Secured Term Loan Facility) and (3) 100% of the net cash proceeds of all non-ordinary course asset sales or other dispositions of property (including casualty events) by the Company or by its subsidiaries, subject to reinvestments rights and certain other exceptions.
Pursuant to the annual excess cash flow requirements defined in the preceding credit agreement, the Company was required to prepay $13,163,000 of outstanding term loans in the first quarter of fiscal year 2011 ($17,583,000 for the fiscal year 2009 which was paid in the first quarter of fiscal year 2010).
On May 6, 2008, the Company issued $235,000,000 of 12.75% senior unsecured notes due March 1, 2016, (the “Senior Unsecured Notes”). The Senior Unsecured Notes were priced at $0.9884 with a yield to maturity of 13.16%. The Senior Unsecured Notes are subordinated to the Credit Facility and Senior Secured Notes.
The Company may redeem some or all of the Senior Unsecured Notes prior to March 1, 2012, at a redemption price equal to 100% of the principal amount of the Senior Unsecured Notes redeemed plus a “make-whole” premium and accrued and unpaid interest. On or after March 1, 2012, the Company may redeem some or all of the Senior Unsecured Notes at the redemption prices (expressed as percentages of principal amount of the Senior Unsecured Notes to be redeemed) set forth below:
         
    Senior  
    Unsecured  
    Notes  
    %  
2012
    106.375  
2013
    103.188  
2014 and thereafter
    100.000  

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APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Payments required in each of the next five twelve-month periods to meet the retirement provisions of the long-term debt are as follows:
         
    $  
2012
    8,918  
2013
    8,918  
2014
    7,858  
2015
    7,500  
2016
    242,500  
Thereafter
    710,625  
 
 
    986,319  
Unamortized original issuance discount
    5,231  
 
 
    981,088  
 
12. Information Included in the Consolidated Operations and Cash Flows
a) Financial expenses
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
    $     $     $     $  
Interest on long-term debt (including amortization of original issuance discount of $510 and $1,020 in 2011($511 and $1,027 in 2010)
    17,166       14,568       31,772       29,379  
Interest and bank charges
    277       323       522       425  
Interest rate swaps (Note 16)
          113             17  
Financing fees
    10,422       143       10,557       278  
Amortization of deferred debt issue expenses
    2,280       1,238       3,523       2,483  
 
 
    30,145       16,385       46,374       32,582  
 
b) Other information
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
    $     $     $     $  
Rental expenses
    973       973       1,857       1,877  
Shipping and handling expenses
    1,862       1,678       3,200       3,294  
Advertizing expenses
    2,512       3,957       4,039       7,854  
Depreciation of property, plant and equipment
    3,573       2,095       5,691       4,099  
Amortization of intangible assets
    14,880       11,904       26,335       26,593  
Stock-based compensation expense (recovery)
    5,272       (2,367 )     5,763       (891 )
 
c) Employee benefit plan
A subsidiary of the Company has a defined contribution plan (the “Plan”) for its U.S. employees. Participation is available to substantially all U.S. employees. Employees may contribute up to 15% of their gross pay or up to limits set by the U.S. Internal Revenue Service. The Company may make matching contributions of a discretionary percentage. The Company charged to operations contributions to the plan totaling $194,000 for the three-month period and $361,000 for the six-month period ended March 31, 2011, ($186,000 for the three-month period and $402,000 for the six-month period ended March 31, 2010).

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APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
d) Employees severance indemnities
The liability for severance indemnities relates primarily to Eurand ‘s and now the Company’s employees in Italy. The unfunded severance indemnity liability is calculated in accordance with local civil and labor laws based on each employee’s length of service, employment category and remuneration. There is no vesting period or funding requirement associated with the liability. The liability recorded on the balance sheet is the amount the employee would be entitled to if the employee were to immediately terminate their employment involuntary.
e) Cash flows relating to interest and income taxes of operating activities
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
    $     $     $     $  
Interest received
    115       159       307       307  
Interest paid
    18,678       27,172       20,012       29,119  
Income taxes received
    744             744       2,372  
Income taxes paid
    3,160       752       5,445       2,608  
 
13. Income Taxes
The Company establishes a valuation allowance against deferred tax assets in accordance with U.S. GAAP. As at March 31, 2011, the Company has a valuation allowance of $112,692,000 against the Company’s net deferred tax assets generated in the U.S. reporting unit and of $4,275,000 against the deferred tax assets generated in its European reporting unit. In future periods, if the deferred tax assets are determined by management to be more likely than not to be realized, the tax benefits relating to the reversal of the valuation allowance will be recorded.
The Company’s effective tax rates for the three-month and six-month periods ended March 31, 2011, were 5.9% and 4.5% respectively, as compared to minus 15.4% and minus 16.3% respectively in the prior year’s periods. The effective tax rate for the three-month and six-month periods ended March 31, 2011, is affected by a number of elements, the most important being the establishment of the valuation allowance of $29,585,000 against the Company’s net deferred tax assets mostly attributable to the U.S. reporting unit during the six-month period ended March 31, 2011.
As at March 31, 2011, with respect to uncertain tax positions, the Company had unrecognized tax benefits of $12,110,000 ($11,485,000 as at September 30, 2010).
The following table presents a summary of the changes to unrecognized tax benefits:
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
    $     $     $     $  
Balance, beginning of period
    10,834       10,896       11,485       10,409  
Acquisition of Eurand
    401             401        
Additions based on tax positions related to the current year
    8       8       16       15  
Additions for tax positions of prior years
    867       414       1,300       920  
Settlements
                (1,063 )      
Reductions for tax positions of prior years
                (29 )     (26 )
 
Balance, end of period
    12,110       11,318       12,110       11,318  
 
The Company has historically recognized interest relating to income tax matters as a component of financial expenses and penalties related to income tax matters as a component of income tax expense. As at March 31, 2011, the Company had accrued $1,237,000 ($1,075,000 as at September 30, 2010) for interest relating to income tax matters. There were no amounts recorded for penalties as at March 31, 2011.
The Company and its subsidiaries file tax returns in the U.S. federal jurisdiction and various states, local and foreign jurisdictions including Canada and France. In many cases, the Company’s uncertain tax positions are related to tax years that remain subject to examination by relevant tax authorities. The Company is subject to federal and state income tax examination by U.S. tax authorities for fiscal years 2005 through 2010. The Company is subject to Canadian and provincial income tax examination for fiscal years 2005 through 2010. There are numerous other income jurisdictions for which tax returns are not yet settled, none of which is individually significant. The Company is currently being audited by Canada Revenue Agency for fiscal year 2005 to fiscal year 2008.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
The Company and its U.S. subsidiaries file as members of a U.S. Federal consolidated income tax return, of which Axcan Holdings Inc. is the parent. The consolidated income tax liability is allocated among the members of the group in accordance with a tax allocation agreement. The tax allocation agreement provides that each member of the group is allocated its share of the consolidated tax provision determined generally on a separate income tax return method.
As at March 31, 2011, and September 30, 2010, no provision has been made for income taxes on the undistributed earnings of the Company’s foreign subsidiaries that the Company intends to indefinitely reinvest.
14. Stock Incentive Plans
Management equity incentive plan
In April 2008, the Company’s indirect parent company adopted a Management Equity Incentive Plan (the “MEIP Plan”), pursuant to which the indirect parent company grants options to selected employees and directors of the Company. The MEIP Plan provides that a maximum of 3,833,307 shares of common stock of the indirect parent company are issuable pursuant to the exercise of options. The per share purchase price cannot be less than the fair value of the share of common stock of the indirect parent company at the grant date and the option expires no later than ten years from the date of grant. Vesting of these stock options is split into 3 categories: 1) time-based options: 50% of option grants generally vest ratably over 5 years and feature a fixed exercise price equal to the fair value of common stock of the indirect parent company on grant date; 2) premium options: 25% of stock option grants with an exercise price initially equal to the fair value of common stock on grant date that will increase by 10% each year and generally vesting ratably over 5 years; and 3) performance-based options: 25% of stock option grants with a fixed exercise price equal to the fair value of common stock on grant date which vest upon the occurrence of a liquidity event (as defined under the terms of the MEIP Plan) based on the achievement of return targets calculated based on the return received by majority shareholders from the liquidity event. While the time-based options and the premium options are expensed over the requisite service period, the performance-based options will not be expensed until the occurrence of the liquidity event.
Special equity grant
In April 2008, the indirect parent company approved the Restricted Stock Unit grant agreement and the penny option grant agreement (collectively “Equity Grant Agreements”) pursuant to which a one-time grant of equity-based awards of either restricted stock units (“RSUs”) or options to purchase shares of common stock of the indirect parent company for a penny (“Penny Options”) was made to certain employees of the Company. A maximum of 1,343,348 shares of common stock of the indirect parent company are issuable with respect to the special grants. As a result of the option to allow the recipients to elect to have an amount withheld that is in excess of the required minimum withholding under the current tax law, the special grants will be accounted for as liability awards. As a liability award, the fair value on which the expense is based is remeasured each period based on the estimated fair value and the final expense will be based on the fair value of the shares on the date the award is settled. The RSUs and Penny Options expire no later than four years and ten years respectively from the date of grant. One third of the granted RSUs and Penny Options vested immediately on date of grant; one third vested on August 25, 2009, and the remainder vested on August 25, 2010.
The carrying value of an RSU or Penny Option is always equal to the estimated fair value of one common share of the indirect parent company. The RSUs and Penny Options entitle the holders to receive common shares of the indirect parent company at the end of a vesting period. The total number of RSUs and Penny Options granted were 1,343,348 with an initial fair value of $10, equal to the share price at the date of grant. As at March 31, 2011, there were 1,086,247 outstanding RSUs and Penny Options (1,172,396 as at September 30, 2010) of which 1,082,913 (1,167,396 as at September 30, 2010) were vested.
Annual grant
In June 2008, the Company’s indirect parent company adopted a Long Term Incentive Plan (the “LTIP”), pursuant to which the indirect parent company is expected to grant annual awards to certain employees of the Company (the “participants”). The value of an award is initially based on the participant’s pay grade and base salary and is subsequently adjusted based on the outcome of certain performance conditions relating to the fiscal year. Each award that vests is ultimately settleable, at the option of the participant, in cash or in parent company common stock of equivalent value. The awards vest (i) upon the occurrence of a liquidity event (as defined under the terms of the LTIP) and (ii) in varying percentages based on the level of return realized by majority shareholders as a result of the liquidity event.
The awards granted under this LTIP are classified as liabilities in accordance with the FASB issued guidance on distinguishing liabilities from equity, since the award is for a fixed amount of value that can be settled, at the option of the participant, in (i) cash, or (ii) a variable number of parent company common stock of equivalent value.
The Company will not recognize any compensation expense until such time as the occurrence of a liquidity event generating sufficient return to the majority shareholders (in order for the award to vest) is probable. If such an event was probable as of March 31, 2011, the value of the awards to be expensed by the Company would range between $6,000,000 and $7,200,000 depending on the level of return expected to be realized by the majority shareholders.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
15. Financial Instruments
Interest rate risk
The Company is exposed to interest rate risk on its variable interest bearing term loans. The term loans bear interest based on British Banker Association LIBOR. As further disclosed in Note 16, the Company may enter into derivative financial instruments to manage its exposure to interest rate changes and reduce its overall cost of borrowing. As described in the subsequent events (Note 19), the Company entered into two separate pay-fixed, receive-floating interest rate swaps on April 4, 2011.
Currency risk
The Company is exposed to financial risk arising from fluctuations in foreign exchange rates and the degree of volatility of the rates. The Company has used derivative instruments historically to reduce its exposure to foreign currencies risk. As at March 31, 2011, no foreign exchange contracts were outstanding. As at March 31, 2011, the financial assets totaling $163,272,000 ($194,005,000 as at September 30, 2010) include cash and cash equivalents and accounts receivable for CAN$7,472,000, 25,888,000 Euros and 1,403,000 Swiss francs respectively (CAN$4,073,000, 18,658,000 Euros and 1,820,000 Swiss francs as at September 30, 2010). As at March 31, 2011, the financial liabilities totaling $1,112,850,000 ($689,148,000 as at September 30, 2010) include accounts payable and accrued liabilities and long-term debt of CAN$8,328,000, 21,359,000 Euros and 29,000 Swiss francs respectively (CAN$10,234,000 and 8,158,000 Euros as at September 30, 2010).
Credit risk
As at March 31, 2011, the Company had $47,484,000 ($134,299,000 as at September 30, 2010) of cash invested in with one financial institution. At times, such deposits may exceed the amount insured by the Federal Deposit Insurance Corporation.
Fair value of the financial instruments on the balance sheet
The estimated fair value of the financial instruments is as follows:
                                 
    March 31, 2011     September 30, 2010  
    Fair     Carrying     Fair     Carrying  
    value     amount     value     amount  
    $     $     $     $  
Assets
                               
Cash and cash equivalents
    87,330       87,330       161,503       161,503  
Accounts receivable from the parent company
    526       526       487       487  
Accounts receivable, net
    75,416       75,416       32,015       32,015  
Liabilities
                               
Accounts payable and accrued liabilities
    131,762       131,762       94,673       94,673  
Long-term debt
    1,010,662       981,088       608,535       594,475  

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
The following methods and assumptions were used to calculate the estimated fair value of the financial instruments on the balance sheet.
a) Financial instruments for which fair value is deemed equivalent to carrying amount
The estimated fair value of certain financial instruments shown on the consolidated balance sheet is equivalent to their carrying amount. These financial instruments include cash and cash equivalents, accounts receivable, net, accounts receivable from the parent company, accounts payable and accrued liabilities.
b) Long-term debt
The fair value of the long-term debt bearing interest at fixed rates has been established according to market prices obtained from a large U.S. financial institution. The fair value of the variable interest bearing term loan has been established based on broker-dealer quotes.
16. Derivates and Hedging Activities
Risk management objective of using derivatives
The Company is exposed to certain risk arising from both its business operations and economic conditions. The Company principally manages its exposures to a wide variety of business and operational risks through management of its core business activities. The Company manages economic risks, including interest rate, liquidity and credit risk primarily by managing the amount, sources, conditions and duration of its debt funding and the use of derivative financial instruments. Specifically, the Company enters into derivative financial instruments to manage exposures that arise from business activities that result in the payment of future known and uncertain cash amounts, the value of which are determined by interest rates. The Company’s derivative financial instruments, if any, are used to manage differences in the amount, timing and duration of the Company’s known or expected cash payments principally related to the Company’s borrowings.
Cash flow hedges of interest rate risk
The Company’s objectives in using interest rate derivatives are to add stability to interest expense and to manage its exposure to interest rate movements. To accomplish this objective, the Company primarily uses interest rate swaps as part of its interest rate risk management strategy. Interest rate swaps designated as cash flow hedges involve the receipt of variable-rate amounts from a counterparty in exchange for the Company making fixed-rate payments over the life of the agreements without exchange of the underlying notional amount. During the three-month and six-month periods ended March 31, 2010, such derivatives were used to hedge the variable cash flows associated with existing variable-rate debt.
The effective portion of changes in the fair value of derivatives designated and that qualify as cash flow hedges is recorded in Accumulated Other Comprehensive Income and is subsequently reclassified into earnings in the period that the hedged forecasted transaction affects earnings. The ineffective portion of the change in fair value of the derivatives is recognized directly in earnings.
Amounts reported in Accumulated Other Comprehensive Income related to derivatives will be reclassified to interest expense as interest payments are made on the Company’s variable-rate debt.
In March 2009, the Company had entered into a pay-fixed, receive-floating interest rate swap of a notional amount of $52,000,000 amortizing to $13,000,000 through February 2010. The Company’s two interest rate swaps with a combined notional amount of $63,000,000 that were designated as cash flow hedges of interest rate risk matured during the quarter ended March 31, 2010, and the Company has not entered into new derivative agreements.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
The tables below present the effect of the Company’s derivative financial instruments on the consolidated operations as at March 31, 2011, and March 31, 2010.
Tabular disclosure of the effect of derivative instruments for the three-month and six-month periods ended March 31, 2011, and 2010:
                         
    Location in the     For the     For the  
    Condensed     three-month     three-month  
    Consolidated     period ended     period ended  
    Financial     March 31,     March 31,  
    Statements     2011     2010  
            $     $  
Interest rate swaps in cash flow hedging relationships
                       
Gain (loss) recognized in other comprehensive income on derivatives (effective portion, net of tax of $1 in 2010
    OCI             (3 )
Gain (loss) reclassified from accumulated comprehensive income into income (effective portion)
    Financial
expenses
            (113 )
Gain (loss) recognized in income on derivatives (ineffective portion and amount excluded from effectiveness testing)
    Financial
expenses
             
 
                       
Interest rate swaps not designated as hedging instruments
                   
Loss recognized in income on derivatives
  Financial expenses            
                         
    Location in the     For the     For the  
    Condensed     six-month     six-month  
    Consolidated     period ended     period ended  
    Financial     March 31,     March 31,  
    Statements     2011     2010  
            $     $  
Interest rate swaps in cash flow hedging relationships
                       
Gain (loss) recognized in other comprehensive income on derivatives (effective portion), net of tax of $166 in 2010
    OCI             (309 )
Gain (loss) reclassified from accumulated comprehensive income into income (effective portion)
    Financial
expenses
            (464 )
Gain (loss) recognized in income on derivatives (ineffective portion and amount excluded from effectiveness testing)
    Financial
expenses
            447  
 
                       
Interest rate swaps not designated as hedging instruments
                   
Loss recognized in income on derivatives
    Financial
expenses
             
 
17. Fair Value Measurements
Effective October 1, 2008, the Company adopted the authoritative guidance for fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The guidance also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The guidance describes three levels of inputs that may be used to measure fair value:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 — Inputs that are unobservable and significant to the overall fair value measurement.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
If the inputs used to measure the financial assets and liabilities fall within the different levels described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.
There are no financial assets and liabilities measured at fair value on a recurring basis as at March 31, 2011, and September 30, 2010.
Interest rate swap agreements as more fully described in Note 16 and are measured at fair value based on observable market interest rate curves as of the measurement date.
During the three-month period ended March 31, 2010, the Company recorded a goodwill impairment charge of $91,400,000 and an intangible assets impairment charge of $15,758,000 related to the PEPs event. The fair value measurement method used in the Company’s impairment analysis utilized a discounted cash flow model and market approach that incorporates significant unobservable inputs or Level 3 assumptions. These assumptions include, among others, projections of the Company’s future operating results, the implied fair value using an income approach by preparing a discounted cash flow analysis and other subjective assumptions.
18. Related Party Transactions
As at March 31, 2011, and September 30, 2010, the Company had a note receivable from its parent company amounting to $133,154,000. During the three-month periods ended March 31, 2011, and March 31, 2010, the Company earned interest income on the note amounting to $1,931,000 net of taxes amounting to $1,040,000 and $3,905,000 net of taxes amounting to $2,103,000 for the six-month periods ended March 31, 2011, and March 31, 2010. The related interest receivable from the parent company amounting to $33,139,000 as at March 31, 2011, ($27,130,000 as at September 30, 2010) has been recorded in the shareholders’ equity section of the condensed consolidated balance sheet. This amount was subject to a full provision which was also recorded in the statement of shareholders’ equity. As at March 31, 2011, the Company has an account receivable from the parent company amounting to $526,000 ($487,000 as at September 30, 2010).
During the three-month period ended March 31, 2011, the Company recorded charges pursuant to the terms of a management fee arrangement with a controlling shareholding company amounting to $730,000 and $1,568,000 during the three-month period and the six-month period ended March 31, 2011($1,000,000 during the three-month period and $1,855,000 during the six-month period ended March 31, 2010). Also, during the three-month and six-month periods ended March 31, 2011, the Company recorded fees from a controlling shareholding company amounting to $5,028,000 of which $1,508,000 was accounted for as deferred debt issue costs, $2,514,000 as selling and administrative expense and $1,006,000 as financing fees. As at March 31, 2011, the Company accrued fees payable to a controlling shareholding company amounting to $770,000 ($1,574,000 as at September 30, 2010).
During the three-month and six-month periods ended March 31, 2011, the Company paid a dividend to its parent company amounting to $25,000 ($128,000 during the six-month period ended March 31, 2010) to allow for the payment of certain group expenses.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
19. Subsequent Events
Agreements with Mpex Pharmaceuticals Inc. for the acquisition and development of Aeroquin
On April 11, 2011, Axcan Holdings Inc., an indirect parent company of the Company, entered into a series of agreements with Mpex Pharmaceuticals Inc. (“Mpex”) for the acquisition and development of Aeroquin™ (the “Aeroquin Transaction”), a proprietary aerosol formulation of levofloxacin, which is currently in Phase 3 clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis (CF). Under these agreements, Axcan Holdings has an option to acquire all of Mpex’s assets related to Aeroquin™ in a merger, with continued development of Aeroquin™ by Mpex under the terms of a Development Agreement between the parties. Prior to the merger Mpex will transfer all of its assets that are not related to Aeroquin™ to a newly formed company that will be owned primarily by current Mpex stockholders. As a result of the Aeroquin Transaction, the Company made an initial non-contingent payment of $12,000,000 on April 21, 2011. Additional remaining time-based, non-contingent payments in relation with the Aeroquin Transaction amounting to $50,500,000 will be paid in a number of additional installments, of which the final installment is due on November 1, 2013.
Under the terms of the Option Agreement dated April 11, 2011 among Axcan Holdings, Mpex, and Axcan Lone Star Inc., a Delaware corporation and an indirect wholly-owned subsidiary of Axcan Holdings and a direct wholly-owned subsidiary of the Company (“Merger Sub”), Axcan Holdings has an option to terminate the Merger Agreement described below. This option may be exercised during a certain period of time, which period in no event will end later than August 1, 2011.
Under the terms of the Agreement and Plan of Merger dated April 11, 2011 (the “Merger Agreement”) among Axcan Holdings, Merger Sub, Mpex and certain stockholders of Mpex who will serve as representatives of the Mpex security holders under the Merger Agreement, Merger Sub will merge with and into Mpex, with Mpex surviving (the “Surviving Company”) as an indirect wholly-owned subsidiary of Axcan Holdings and a direct wholly-owned subsidiary of the Company (the “Merger”). Pursuant to the Merger Agreement, the aggregate merger consideration that the Mpex security holders will receive, subject to the consummation of the Merger, consists of (i) the non-contingent payments mentioned above; (ii) contingent payments of up to $195,000,000 if certain regulatory and commercial milestones are met related to Aeroquin™, and (iii) earn-out payments based on net sales of Aeroquin™. Indemnity obligations of the Mpex security holders will be satisfied by set-off against a portion of the foregoing merger consideration payments.
Unless terminated pursuant to the Option Agreement described above, the Merger is expected to close during the third quarter of 2011. The further development of Aeroquin™ will be conducted pursuant to the terms of the Development Agreement dated April 11, 2011 among Axcan Holdings, Merger Sub, and Mpex. Upon completion of the divestiture of assets and liabilities unrelated to Aeroquin™ (the “Divestiture”) to a newly formed company (“Spinco”), Spinco will assume all of Mpex’s obligations under the Development Agreement. Under the Development Agreement, Mpex (and after the Divestiture, Spinco) will be paid for the actual development costs of Aeroquin™ and will have primary responsibility for conducting day-to-day development activities. Axcan Holdings and Merger Sub will have input regarding development strategy. Pursuant to the Development Agreement, on April 12, 2011 Mpex was paid $9,196,000 for development expenses incurred by Mpex since November 15, 2010 and $9,448,000 for estimated development costs to be incurred during the first three months of the Development Agreement. All payments under the Development Agreement, Option Agreement and Merger Agreement to Mpex or Mpex security holders, as applicable, will be made by or on behalf of Merger Sub (or after the consummation of the Merger, the Surviving Company).
Equity investment in Axcan Holdings
Simultaneous with the execution of the Mpex agreements, Axcan Holdings received the proceeds of a $55,000,000 equity investment from funds managed by Investor Growth Capital Limited. Axcan Holdings will contribute the proceeds of the equity investment to its subsidiaries to fund a portion of the cost of the Mpex transactions and a partial repayment on the Company’s $133,154,000 note receivable from its parent company.
Risk management measures undertaken to reduce exposure to interest rate fluctuations
On April 4, 2011, the Company entered into two separate pay-fixed, receive-floating interest rate swaps. The first swap has a notional amount of $331,000,000 amortizing to $84,000,000 by its maturity in December 2015. The second swap has a notional amount of $219,000,000 and matures in December 2016. The interest rate swaps will effectively fix the Company’s interest payments on the hedged debt at 2.386% for the first swap and 3.18% for the second swap, respectively, inclusive of a labor floor of 1.5%, plus the appropriate margin on each debt interest period. These swaps were designated as cash flow hedges of interest rate risk.

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
20. Condensed Consolidating Financial Information
As of March 31, 2011, the Company had outstanding $746,626,000 aggregate principal amount of the Senior Secured Term Loan Facility. The Senior Secured Term Loan Facility is fully and unconditionally guaranteed, jointly and severally by certain of the Company’s wholly-owned subsidiaries.
The following supplemental tables present condensed consolidating balance sheets for the Company and its subsidiary guarantors and non-guarantors as at March 31, 2011, and September 30, 2010, the condensed consolidating statements of operations for the three-month and six-month periods ended March 31, 2011, and March 31, 2010, and the condensed consolidating statement of cash flows for the six-month periods ended March 31, 2011, and March 31, 2010.
Condensed consolidating balance sheet as at March 31, 2011
                                         
                    Subsidiary              
    Aptalis     Subsidiary     non-              
    Pharma Inc.     guarantors     guarantors     Eliminations     Consolidated  
    $     $     $     $     $  
Assets
                                       
Current assets
                                       
Cash and cash equivalents
    3,242       33,246       50,842             87,330  
Accounts receivable, net
          54,168       21,549             75,717  
Accounts receivable from the parent company
    52       474                   526  
Intercompany receivables
    42,041       11,324       16,999       (70,364 )      
Income taxes receivable
          3,260       412             3,672  
Inventories, net
          45,820       26,427       (8,797 )     63,450  
Prepaid expenses and deposits
    123       4,109       1,655       (267 )     5,620  
Deferred income taxes, net
          1,539       1,690       2,878       6,107  
 
Total current assets
    45,458       153,940       119,574       (76,550 )     242,422  
Property, plant and equipment, net
          41,390       48,878             90,268  
Intangible assets, net
          282,145       448,868             731,013  
Investments in subsidiaries
    (140,563 )     1,212,795       184,298       (1,256,530 )      
Intercompany advances
    1,064,659       269,998       641,954       (1,976,611 )      
Goodwill, net
          82,818       98,900             181,718  
Deferred debt issue expenses, net
    30,419       1,817                   32,236  
Deferred income taxes, net
          58       14,348             14,406  
 
Total assets
    999,973       2,044,961       1,556,820       (3,309,691 )     1,292,063  
 
Liabilities
                                       
Current liabilities
                                       
Accounts payable and accrued liabilities
    6,126       94,673       31,230       (267 )     131,762  
Income taxes payable
          3,097       178             3,275  
Intercompany payables
    2,051       59,090       9,223       (70,364 )      
Short-term portion of long term debt
    6,770       730       1,418             8,918  
Deferred income taxes
                620             620  
 
Total current liabilities
    14,947       157,590       42,669       (70,631 )     144,575  
 
Long-term debt
    898,647       71,747       1,776             972,170  
Intercompany advances
    22,894       1,724,026       229,691       (1,976,611 )      
Other long-term liabilities
          11,252                   11,252  
Employees severance indemnities
                5,080             5,080  
Deferred income taxes
          27,711       67,790             95,501  
 
Total liabilities
    936,488       1,992,326       347,006       (2,047,242 )     1,228,578  
 
Shareholders’ Equity (Deficiency)
                                       
Capital stock
                                       
Common shares
    1       29,519       1,075,397       (1,104,916 )     1  
Preferred shares
          298,298             (298,298 )      
Purchased price allocation at equity
                19,167       (19,167 )      
Retained earnings (deficit)
    (538,400 )     (373,746 )     119,668       254,078       (538,400 )
9.05% Note receivable from the parent company
    (133,154 )                       (133,154 )
Additional paid-in capital
    757,689       121,215       943       (122,158 )     757,689  
Accumulated other comprehensive loss
    (22,651 )     (22,651 )     (5,361 )     28,012       (22,651 )
 
Total shareholders’ equity (deficiency)
    63,485       52,635       1,209,814       (1,262,449 )     63,485  
 
Total liabilities and shareholders’ equity (deficiency)
    999,973       2,044,961       1,556,820       (3,309,691 )     1,292,063  
 

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating balance sheet as at September 30, 2010
                                         
                    Subsidiary              
    Aptalis     Subsidiary     non-              
    Pharma Inc.     guarantors     guarantors     Eliminations     Consolidated  
    $     $     $     $     $  
Assets
                                       
Current assets
                                       
Cash and cash equivalents
    864       104,608       56,031             161,503  
Accounts receivable, net
          19,262       13,117             32,379  
Accounts receivable from the parent company
    50       437                   487  
Intercompany receivables
    11,092       1,618       4,265       (16,975 )      
Income taxes receivable
          2,906                   2,906  
Inventories, net
          17,697       6,563       (394 )     23,866  
Prepaid expenses and deposits
    48       2,385       844             3,277  
Deferred income taxes, net
          1,355       857       119       2,331  
 
Total current assets
    12,054       150,268       81,677       (17,250 )     226,749  
Property, plant and equipment, net
          27,383       8,394             35,777  
Intangible assets, net
          285,703       62,259             347,962  
Investments in subsidiaries
    (354,104 )     830,813       78,175       (554,884 )      
Intercompany advances
    826,431       91,811       679,391       (1,597,633 )      
Goodwill, net
          61,887       11,653             73,540  
Deferred debt issue expenses, net
    18,021       2,422                   20,443  
Deferred income taxes, net
                8,706             8,706  
 
Total assets
    502,402       1,450,287       930,255       (2,169,767 )     713,177  
 
Liabilities
                                       
Current liabilities
                                       
Accounts payable and accrued liabilities
    5,975       77,887       10,811             94,673  
Income taxes payable
          1,938       1,508             3,446  
Intercompany payables
    449       15,340       1,186       (16,975 )      
Installments on long-term debt
    5,546       7,617                   13,163  
Deferred income taxes
          47                   47  
 
Total current liabilities
    11,970       102,829       13,505       (16,975 )     111,329  
Long-term debt
    510,663       70,649                   581,312  
Intercompany advances
    801       1,512,092       84,740       (1,597,633 )      
Other long-term liabilities
          10,028                   10,028  
Deferred income taxes
          30,618       922             31,540  
 
Total liabilities
    523,434       1,726,216       99,167       (1,614,608 )     734,209  
 
Shareholders’ Equity (Deficiency)
                                       
Capital stock
                                       
Common shares
    1       21,020       735,742       (756,762 )     1  
Preferred shares
          78,175             (78,175 )      
Retained earnings (deficit)
    (468,152 )     (354,020 )     98,657       255,363       (468,152 )
9.05% Note receivable from the parent company
    (133,154 )                       (133,154 )
Additional paid-in capital
    614,113       12,736       689       (13,425 )     614,113  
Accumulated other comprehensive loss
    (33,840 )     (33,840 )     (4,000 )     37,840       (33,840 )
 
Total shareholders’ equity (deficiency)
    (21,032 )     (275,929 )     831,088       (555,159 )     (21,032 )
 
Total liabilities and shareholders’ equity (deficiency)
    502,402       1,450,287       930,255       (2,169,767 )     713,177  
 

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating operations for the three-month period ended March 31, 2011
                                         
                    Subsidiary              
    Aptalis     Subsidiary     non-              
    Pharma Inc.     guarantors     guarantors     Eliminations     Consolidated  
    $     $     $     $     $  
Net product sales
          89,191       20,496       87       109,774  
Development fees
          497       102             599  
Royalties
          920       67             987  
 
Total revenue
          90,608       20,665       87       111,360  
 
Cost of goods sold
          22,597       7,098       2,158       31,853  
Selling and administrative expenses
    16,197       13,987       8,860             39,044  
Management fees
    730                         730  
Research and development expenses
          8,392       2,591             10,983  
Other research and development expenses attributable to development fees
          631       224             855  
Depreciation and amortization
          12,449       6,004             18,453  
Loss on disposal of assets
          7,365                   7,365  
Transaction and restructuring costs
          15,501       3,748             19,249  
 
Total operating expenses
    16,927       80,922       28,525       2,158       128,532  
 
Operating income (loss)
    (16,927 )     9,686       (7,860 )     (2,071 )     (17,172 )
 
Financial expenses
    28,087       30,659       2,245       (30,846 )     30,145  
Loss of extinguishment of debt
    24,269       4,042                   28,311  
Interest income
    (14,119 )     (2,273 )     (14,577 )     30,846       (123 )
Other income
                (241 )     241        
Loss (gain) on foreign currencies
    (14,401 )     9,620       470       4,944       633  
 
Total other expenses (income)
    23,836       42,048       (12,103 )     5,185       58,966  
 
Income (loss) before income taxes
    (40,763 )     (32,362 )     4,243       (7,256 )     (76,138 )
Income taxes expense (benefit)
    (1,042 )     (1,788 )     (979 )     (660 )     (4,469 )
Equity in earnings (loss) in subsidiaries
    (31,948 )     (1,374 )           33,322        
 
Net income (loss)
    (71,669 )     (31,948 )     5,222       26,726       (71,669 )
 

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating operations for the three-month period ended March 31, 2010
                                         
                    Subsidiary              
    Aptalis     Subsidiary     non-              
    Pharma Inc.     guarantors     guarantors     Eliminations     Consolidated  
    $     $     $     $     $  
Net product sales
          77,560       17,114       (309 )     94,365  
 
Cost of goods sold
          61,535       6,586       29       68,150  
Selling and administrative expenses
    1,002       20,902       6,502             28,406  
Management fees
    1,000                         1,000  
Research and development expenses
          6,063       1,620             7,683  
Depreciation and amortization
          12,045       1,954             13,999  
Impairment of intangible assets and goodwill
          107,158                   107,158  
 
Total operating expenses
    2,002       207,703       16,662       29       226,396  
 
Operating income (loss)
    (2,002 )     (130,143 )     452       (338 )     (132,031 )
 
Financial expenses
    14,946       27,856       1,805       (28,222 )     16,385  
Interest income
    (12,067 )     (1,935 )     (14,379 )     28,222       (159 )
Other income
          (7,700 )                 (7,700 )
Loss (gain) on foreign currencies
    16,148       (9,604 )     117       (5,253 )     1,408  
 
Total other expenses (income)
    19,027       8,617       (12,457 )     (5,253 )     9,934  
 
Income (loss) before income taxes
    (21,029 )     (138,760 )     12,909       4,915       (141,965 )
Income taxes expense (benefit)
    37,612       (15,169 )     (546 )     (102 )     21,795  
Equity in earnings (loss) in subsidiaries
    (105,119 )     18,472             86,647        
 
Net income (loss)
    (163,760 )     (105,119 )     13,455       91,664       (163,760 )
 

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating operations for the six-month period ended March 31, 2011
                                         
                    Subsidiary              
    Aptalis     Subsidiary     non-              
    Pharma Inc.     guarantors     guarantors     Eliminations     Consolidated  
    $     $     $     $     $  
 
                                       
Net product sales
          157,703       38,034       (25 )     195,712  
Development fees
          497       102             599  
Royalties
          920       67             987  
 
Total evenue
          159,120       38,203       (25 )     197,298  
 
Cost of goods sold
          33,556       13,683       2,037       49,276  
Selling and administrative expenses
    20,723       27,636       15,856             64,215  
Management fees
    1,568                         1,568  
Research and development expenses
          15,198       2,740             17,938  
Other research and development expenses attributable to development fees
          631       224             855  
Depreciation and amortization
          24,170       7,856             32,026  
Loss on disposal of assets
          7,365                   7,365  
Transaction and restructuring costs
          18,549       3,748             22,297  
 
Total operating expenses
    22,291       127,105       44,107       2,037       195,540  
 
Operating income (loss)
    (22,291 )     32,015       (5,904 )     (2,062 )     1,758  
 
Financial expenses
    43,011       59,459       4,033       (60,129 )     46,374  
Loss of extinguishment of debt
    24,269       4,042                   28,311  
Interest income
    (26,362 )     (4,184 )     (29,898 )     60,129       (315 )
Other income
                (483 )     483        
Loss (gain) on foreign currencies
    (10,604 )     7,585       313       3,582       876  
 
Total other expenses (income)
    30,314       66,902       (26,035 )     4,065       75,246  
 
Income (loss) before income taxes
    (52,605 )     (34,887 )     20,131       (6,127 )     (73,488 )
Income taxes expense (benefit)
    (2,105 )     372       (880 )     (652 )     (3,265 )
Equity in earnings (loss) in subsidiaries
    (19,723 )     15,536             4,187        
 
Net income (loss)
    (70,223 )     (19,723 )     21,011       (1,288 )     (70,223 )
 

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating operations for the six-month period ended March 31, 2010
                                         
                    Subsidiary              
    Aptalis     Subsidiary     non-              
    Pharma Inc.     guarantors     guarantors     Eliminations     Consolidated  
    $     $     $     $     $  
Net product sales 
          172,583       33,220       (1,306 )     204,497  
 
Cost of goods sold
          84,084       11,662       (968 )     94,778  
Selling and administrative expenses
    1,345       45,303       13,997             60,645  
Management fees
    1,855                         1,855  
Research and development expenses
          13,770       2,339             16,109  
Depreciation and amortization
          26,656       4,036             30,692  
Impairment of intangible assets and goodwill
          107,158                   107,158  
 
Total operating expenses
    3,200       276,971       32,034       (968 )     311,237  
 
Operating income (loss)
    (3,200 )     (104,388 )     1,186       (338 )     (106,740 )
 
Financial expenses
    29,903       56,517       3,765       (57,603 )     32,582  
Interest income
    (24,536 )     (3,930 )     (29,444 )     57,603       (307 )
Other income
          (7,700 )                 (7,700 )
Loss (gain) on foreign currencies
    22,865       (14,268 )     (22 )     (7,182 )     1,393  
 
Total other expenses (income)
    28,232       30,619       (25,701 )     (7,182 )     25,968  
 
Income (loss) before income taxes
    (31,432 )     (135,007 )     26,887       6,844       (132,708 )
Income taxes expense (benefit)
    33,971       (11,328 )     (935 )     (102 )     21,606  
Equity in earnings in subsidiaries
    (88,911 )     34,768             54,143        
 
Net income (loss)
    (154,314 )     (88,911 )     27,822       61,089       (154,314 )
 

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating cash flows for the six-month period ended March 31, 2011
                                         
                    Subsidiary              
    Aptalis     Subsidiary     non-              
    Pharma Inc.     guarantors     guarantors     Eliminations     Consolidated  
    $     $     $     $     $  
Cash flows from operating activities
                                       
Net cash provided by (used in) operating activities
    (79,627 )     40,262       (1,857 )           (41,222 )
 
 
                                       
Cash flows from investing activities
                                       
Acquisition, net of cash acquired
                (525,667 )           (525,667 )
Disposal of intangible assets
          500                   500  
Acquisition of property, plant and equipment
          (1,913 )     (1,593 )           (3,506 )
Intercompany advances
    (330,397 )     (156,548 )     52,341       434,604        
Investments in subsidiaries
    (114,000 )     (339,621 )     (106,123 )     559,744        
 
Net cash used in investing activities
    (444,397 )     (497,582 )     (581,042 )     994,348       (528,673 )
 
 
                                       
Cash flows from financing activities
                                       
Issuance of long-term debt
    673,615       72,635                   746,250  
Repayment of long-term debt
    (288,184 )     (80,515 )     (351 )           (369,050 )
Stock-based compensation plan redemptions
    (84 )                       (84 )
Defered debt issue expenses
    (21,014 )     (1,949 )                 (22,963 )
Intercompany advances
    22,094       175,659       236,851       (434,604 )      
Dividends paid
    (25 )                       (25 )
Capital contribution
    140,000                         140,000  
Issue of shares
          220,123       339,621       (559,744 )      
 
Net cash provided by (used in) financing activities
    526,402       385,953       576,121       (994,348 )     494,128  
 
Foreign exchange loss on cash held in foreign currencies
          5       1,589             1,594  
 
Net increase (decrease) in cash and cash equivalents
    2,378       (71,362 )     (5,189 )           (74,173 )
Cash and cash equivalents, beginning of period
    864       104,608       56,031             161,503  
 
Cash and cash equivalents, end of period
    3,242       33,246       50,842             87,330  
 

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APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating cash flows cash flows for the six-month period ended March 31, 2010
                                         
                    Subsidiary              
    Aptalis     Subsidiary     non-              
    Pharma Inc.     guarantors     guarantors     Eliminations     Consolidated  
    $     $     $     $     $  
Cash flows from operating activities
                                       
Net cash provided by (used in) operating activities
    (56,048 )     92,699       22,968             59,619  
 
 
                                       
Cash flows from investing activities
                                       
Acquisition of property, plant and equipment
          (3,089 )     (373 )           (3,462 )
Intercompany advances
    45,791       166       (86 )     (45,871 )      
Investments in subsidiaries
                (68,000 )     68,000        
 
Net cash provided by (used in) investing activities
    45,791       (2,923 )     (68,459 )     22,129       (3,462 )
 
 
                                       
Cash flows from financing activities
                                       
Repayment of long-term debt
    (8,791 )     (12,074 )                 (20,865 )
Stock-based compensation plan redemptions
    (328 )                       (328 )
Intercompany advances
    18,870       (65,081 )     340       45,871        
Dividends paid
    (128 )                       (128 )
Issue of shares
          68,000             (68,000 )      
 
Net cash provided by (used in) financing activities
    9,623       (9,155 )     340       (22,129 )     (21,321 )
 
Foreign exchange gain (loss) on cash held in foreign currencies
          11       (868 )           (857 )
 
Net increase (decrease) in cash and cash equivalents
    (634 )     80,632       (46,019 )           33,979  
Cash and cash equivalents, beginning of period
    702       41,859       83,874             126,435  
 
Cash and cash equivalents, end of period
    68       122,491       37,855             160,414  
 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
On May 4, 2011, Axcan Intermediate Holdings Inc. announced that it has changed its name to Aptalis Pharma Inc.
You should read the following discussion in conjunction with the Condensed Consolidated Interim Financial Statements and the related notes that appear in Part I, Item 1 of this Quarterly Report. The results of operations for the three-month and six-month periods ended March 31, 2011, and March 31, 2010, reflect the results of operations for Aptalis Pharma Inc. previously known as Axcan Intermediate Holdings Inc. and its consolidated subsidiaries.
Unless the context otherwise requires, in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, the terms “Axcan”, “Aptalis”, “Company”, “we”, “us” and “our” refer to Aptalis Pharma Inc. previously known as Axcan Intermediate Holdings Inc. and its consolidated subsidiaries.
This discussion contains forward-looking statements and involves numerous risks and uncertainties, including but not limited to those described in Part 2, Item 1A of this Quarterly Report and “Item 1A Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended September 30, 2010. Actual results may differ materially from those contained in any forward-looking statements.
OVERVIEW
Our Business
Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, LACTEOL®, DELURSAN®, and SALOFALK®. Our vision is to become the reference specialty pharma company providing innovative, effective therapies for unmet medical needs, including cystic fibrosis and gastrointestinal disorders, and we hope to achieve this through our mission: to improve health and quality of care by providing specialty therapies for patients around the world. The Company will strive to improve patient quality of care thanks to a broad range of products in cystic fibrosis and gastrointestinal disorders, a robust pipeline, technology platform, manufacturing capabilities and a skilled team of professionals with deep understanding of our customers’ needs.
In addition to our marketing activities, the Company also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary pharmaceutical technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations.
We intend to enhance our position as the leading specialty pharmaceutical company concentrating in the field of cystic fibrosis and gastroenterology by pursuing the following strategic initiatives: 1) growing sales of existing products; 2) launching new products; 3) selectively acquiring or in-licensing complementary late stage or in-market products from third parties; 4) pursuing growth opportunities through development pipeline and through our pharmaceutical technologies business; and 5) expanding internationally.
Business Environment
While the ultimate end users of our products are the individual patients to whom our products are prescribed by physicians, our direct customers include a number of large pharmaceutical wholesale distributors and large pharmacy chains. The pharmaceutical wholesale distributors that comprise a significant portion of our customer base sell our products primarily to retail pharmacies, which ultimately dispense our products to the end consumers.
Increasingly, in North America, third-party payors, such as private insurance companies and drug plan benefit managers, aim to rationalize the use of pharmaceutical products and medical treatments, in order to ensure that prescribed products are necessary for the patients’ disorders. Moreover, large drug store chains now account for an increasing portion of retail sales of prescription medicines. The pharmacists and managers of such retail outlets are under pressure to reduce the number of items in inventory in order to reduce costs.
We use a “pull-through” marketing approach that is typical of pharmaceutical companies. Under this approach, our sales representatives actively promote our portfolio products by demonstrating the features and benefits of our products to physicians and, in particular, gastroenterologists and cystic fibrosis centers who may prescribe our products for their patients. The patients, in turn, take the prescriptions to pharmacies to be filled. The pharmacies then place orders, directly or through buying groups, with the wholesalers, to whom we sell our products.
Our expenses are comprised primarily of selling and administrative expenses (including marketing expenses), cost of goods sold (including royalty payments to those companies from which we license some of our commercialized products), research and development expenses, financial expenses as well as depreciation and amortization.
In March 2010, the Health Care and Education Reconciliation Act of 2010 was enacted in the U.S. This healthcare reform legislation contains several provisions that impact our business, which include expanding rebate coverage to managed Medicaid and an increase to the rate of rebates for all our drugs dispensed to Medicaid beneficiaries; expanding the 340(B) drug pricing program requiring drug manufacturers to provide discounted product to reduce the Medicare Part D coverage gap; and assessing a new fee on manufacturers and importers of branded prescription drugs paid for pursuant to coverage provided under specified government programs. The impact of these changes is further discussed below under the “Affordable Care Act” subsection.
On April 29, 2010, we announced that we had taken steps to cease the distribution of ULTRASE MT and VIOKASE, effective April 28, 2010, in response to FDA guidance related to the distribution of unapproved pancreatic enzyme products, or PEPs. The effects of ceasing to distribute these product lines on our financial statements are summarized in the section “Unapproved pancreatic enzyme products (“PEPs”) event” below.

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Acquisition of Eurand N.V. (“Eurand Acquisition”)
On February 11, 2011 or Acquisition Date, Axcan Holdings Inc. (“Axcan Holdings”), the Company’s indirect parent, and Axcan Pharma Holding B.V. (“Axcan AcquisitionCo”), an indirect subsidiary of the Company, pursuant to a Share Purchase Agreement dated November 30, 2010 (as amended) acquired 95.6% (99.1% after giving effect to the additional shares that are guaranteed to be delivered under a notice of guaranteed delivery) of the outstanding shares of Eurand N.V. (“Eurand”) for a purchase price of $12.00 per share in cash resulting in total consideration of approximately $589.6 million for 100% of such shares. We acquired 100% of the outstanding shares of Eurand by March 31, 2011. As a result of the acquisition, Eurand has become an indirect subsidiary. In addition, Axcan AcquisitionCo and other direct and indirect subsidiaries of the Company acquired from Eurand substantially all of Eurand’s assets, including the capital stock of Eurand’s direct and indirect U.S. and foreign subsidiaries, and transferred the capital stock of former Eurand U.S. subsidiaries to the Company.
Prior to the transaction, Eurand was a specialty pharmaceutical company that developed, manufactured and commercialized enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies. Eurand has had six products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles and taste-masking/orally disintegrating tablet (ODT) formulations. Eurand was a global company with facilities in the U.S. and Europe. The acquisition of Eurand will enable us to leverage the combination of two leading specialty pharmaceutical players, expand our gastroenterology product portfolio and provide us with a proprietary R&D growth engine and technology platforms supported by an extensive patent portfolio to meaningfully diversify its business and expand its geographic and manufacturing footprint.
Fair value of consideration transferred
The table below details the consideration transferred to acquire Eurand:
                         
    Conversion             Form of  
    Calculation     Fair Value     Consideration  
    (in millions of U.S. dollars)  
Eurand common stock outstanding as of acquisition date
    48,359,433       580.3     Cash
Mutiplied by cash consideration per common share outstanding
    12.00                
Eurand stock options canceled for a cash payment(a)
            9.3     Cash
 
Total fair value of consideration transferred
            589.6          
 
 
(a)   Each Eurand stock option, whether or not vested and exercisable on the acquisition date, was canceled for a cash payment equal to the excess of the per share value of the acquisition consideration over the per share exercise price of the Eurand stock option.
The aggregate equity purchase price of $589.6 million plus acquisition costs (including related fees and expenses) were funded by cash equity contributions, made through Aptalis Holdings Inc., amounting to $140.0 million from affiliates of TPG Capital L.P. and certain co-investors, the proceeds from the Senior Secured Term Loan Facility (as defined below) under the Company’s amended and restated credit agreement and related security and other agreements and cash on hand from Aptalis and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147.0 million (the “Senior Secured Revolving Credit Facility”) and (ii) a $750.0 million senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”). The Senior Secured Revolving Credit Facility is comprised of $115.0 million of existing revolving credit commitments that were extended or issued on February 11, 2011 (the “ Extended Commitments”) and $32.0 million of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility.
We borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of Aptalis and Eurand, were used to repay the outstanding term loan portion amounting to $125.7 million of the Company’s existing senior secured credit facilities. The remaining amount of $250.0 million of the Senior Secured Term Loan Facility was used on March 15, 2011 to redeem 100% of our existing 9.25% senior secured notes due 2015.
Basis of presentation
The transaction has been accounted for in accordance with the acquisition method of accounting for business combinations under existing U.S. generally accepted accounting principles (“GAAP”). The acquisition method of accounting requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date including acquired in-process research and development assets.

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Assets acquired and liabilities assumed
A preliminary purchase price allocation has been made and the recorded amounts are subject to change. The following recognized amounts are provisional and subject to change:
  Amounts and useful lives for identifiable intangible assets and property, plant and equipment, pending the finalization of valuation efforts;
 
  Amounts for income tax assets and liabilities, pending finalization of estimates and assumptions in respect of certain tax aspects of the transaction, revision to fair value of acquired assets and liabilities, and the filing of Eurand’s pre-acquisition tax returns; and
 
  The allocation of goodwill among reporting units.
We will finalize the purchase price allocation as we obtain the information necessary to complete the measurement process. Any changes resulting from facts and circumstances that existed as of the acquisition date may result in retrospective adjustments to the provisional amounts recognized at the acquisition date. We expect to finalize the purchase price allocation no later than one year from the acquisition date.
Resulting from the preliminary purchase price allocation, the following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date.
                         
                    Amounts  
    Book value as at     Step-up to     recognized as of  
(in millions of U.S. dollars)   February 11, 2011     fair value     acquisition date  
 
    $       $       $  
Cash and cash equivalents
    63.9             63.9  
Accounts receivable (a)
    22.7             22.7  
Inventories (b)
    25.5       18.7       44.2  
Other current assets (c)
    6.6             6.6  
Property, plant and equipment (d)
    44.6       10.9       55.5  
Identifiable intangible assets (d)
    7.0       406.9       413.9  
Current liabilities (e)
    (52.0 )           (52.0 )
Long-term debt, including current portion
    (3.4 )           (3.4 )
Deferred income taxes liabilities, net (f)
    (0.2 )     (61.0 )     (61.2 )
Other non-current liabilities
    (8.5 )     2.3       (6.2 )
 
Total identifiable net assets
    106.2       377.8       484.0  
Goodwill (g)
    37.5       69.0       106.5  
 
Net assets acquired
    143.7       446.8       590.5  
Effective settlement of pre-existing relationships (h)
    (0.9 )           (0.9 )
 
Total fair value of consideration transferred
                    589.6  
 
 
(a)   As of acquisition date, the fair value of accounts receivable acquired approximated book value. The gross contractual amount receivable was $23.2 million, of which $0.5 million was not expected to be collected.
 
(b)   Reflects the adjustment to step-up the carrying value of inventory acquired by $18.7 million to estimated fair value as of February 11, 2011. The stepped-up value is recorded as a charge to cost of goods sold as acquired inventory is sold.
 
(c)   Includes prepaid assets and income tax receivable.
 
(d)   The amounts recorded for the major components of acquired identifiable intangible assets are as follows:
                 
    Amounts     Weighted  
    recognized as of     average useful  
(in millions of U.S. dollars)   acquisition date     lives (years)  
 
    $       $  
Trademarks, trademark licenses, manufacturing rights and other intangible assets with a finite life
    413.9       17.04  
 
Total identifiable intangible assets
    413.9       17.04  
 
        In addition, the estimated aggregate amortization expense for the five succeeding years will be $25.6 million annually.
 
(e)   Includes accounts payable, accrued liabilities and income taxes payable.
 
(f)   Comprises of current deferred tax assets $0.8 million, non-current deferred tax assets $15.7 million and non-current deferred tax liabilities $77.7 million.

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(g)     The excess of purchase price over the fair value amounts assigned to the assets acquired and liabilities assumed represents the goodwill amount resulting from the acquisition. The goodwill recorded as part of the acquisition is largely attributable to synergies expected to result from combining the operations of Eurand and the Company and intangible assets that do not qualify for separate recognition. The Company does not expect any portion of this goodwill to be deductible for tax purposes. The allocation of goodwill among reporting units is not complete, pending finalization of the Company’s internal reporting structure and composition of its post-acquisition operating segments and reporting units.
(h)    The Company had entered into an exclusive development license and supply agreement with Eurand. No gain or loss was recognized in conjunction with the effective settlement of the contractual relationship between the Company and Eurand as a result of this acquisition.
Transaction related costs
During the six-month period ended March 31, 2011, we have expensed $11.3 million (an additional $1.1 million was expensed in the fiscal year ended September 30, 2010) of costs relating to legal, financial, valuation and accounting advisory services performed in connection with effecting the transaction with Eurand, which are included in acquisition and restructuring costs in the accompanying Statement of Condensed Interim Consolidated Operations.
Actual and proforma information
The revenues derived from the Eurand entities for the period from the Acquisition Date to March 31, 2011 were $25.7 million and loss before income taxes was $0.7 million, excluding the effects of the non-recurring acquisition accounting adjustments described above.
The following table presents pro forma consolidated results of operations as if the acquisition of Eurand had occurred as of October 1, 2009:
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
    2011     2010     2011     2010  
 
    $       $       $       $  
Total revenue
    131.5       123.5       261.4       261.4  
Loss before income taxes (a)
    (27.1 )     (108.9 )     (27.5 )     (117.1 )
 
Net loss (a)
    (24.9 )     (130.0 )     (26.4 )     (134.8 )
 
The pro forma consolidated results of operations were prepared using the acquisition method of accounting and are based on the historical financial information of the Company and Eurand. The pro forma information does not reflect any synergies and other benefits that the Company may achieve as a result of the acquisition, or the costs necessary to achieve these synergies. In addition, the pro forma information does not reflect the costs to integrate the operations of the Company and Eurand.
The pro forma information is not necessarily indicative of what the Company’s consolidated results of operations actually would have been had the transaction been completed on October 1, 2009. In addition, the pro forma information does not purport to project the future results of operations of the Company. The pro forma information reflects primarily the following pro forma adjustments:
  elimination of product sales and royalties between Eurand and the Company, an elimination of the Company’s cost of sales for Eurand-sourced inventories, and the elimination of certain PEP-related charges stemming from intercompany transactions;
 
  elimination of Eurand’s historical intangible asset amortization expense;
 
  additional amortization expense related to the fair value of identifiable intangible assets acquired;
 
  additional depreciation expense related to the fair value adjustment to property, plant and equipment acquired;
 
  elimination of interest expense and amortization of deferred financing costs related to the Company’s term loan under the legacy senior secured credit facilities and 9.25% senior secured notes due 2015 that were repaid as part of the acquisition transaction;
 
  additional interest expense and amortization of deferred financing costs associated with financing obtained under the Amended and Restated Senior Secured Credit Facilities obtained by the Company in connection with the acquisition transaction;
 
  reduction of interest income associated with cash and cash equivalents that were used to partially fund the acquisition;
 
  elimination of acquisition-related costs and acquisition-related restructuring charges;
 
  elimination of $4.4 million of the acquisition accounting adjustment on Eurand’s inventory that was sold subsequent to the Aquisition Date, which will not have a continuing impact on the Company’s operations.
The pro forma effective tax rate differs from the statutory rate due to the relatively large impact of actual permanent differences on relatively small pro forma income before tax, valuation allowances on deferred tax assets in certain jurisdictions, and the expected impact of foreign withholding taxes upon repatriation of foreign earnings.

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FINANCIAL OVERVIEW FOR THREE-MONTH AND SIX-MONTH PERIODS ENDED MARCH 31, 2011
This discussion and analysis is based on our unaudited condensed interim financial statements as at March 31, 2011 and our audited annual consolidated financial statements and the related notes thereto reported under U.S. GAAP. The results of Eurand’s business have been included in our results of operations, financial condition and cash flows only for the period subsequent to the completion of the acquisition. For a description of our products, see the section entitled “Business Products” in Item 1, Part I in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010, filed with the Securities and Exchange Commission.
For the three-month period ended March 31, 2011, total revenue was $111.4 million ($94.4 million for the three-month period ended March 31, 2010), operating loss was $17.1 million ($132.1 million for the three-month period ended March 31, 2010) and net loss was $71.7 million ($163.7 million for the three-month period ended March 31, 2010). For the six-month period ended March 31, 2011, total revenue was $197.3 ($204.5 million for the six-month period ended March 31, 2010), operating income was $1.8 million (operating loss of $106.8 million for the corresponding period of fiscal year 2010) and net loss was $70.2 million ($154.3 million for the corresponding period of fiscal year 2010). Total revenue in the United States was $82.4 million (74.0% of total revenue) for the three-month period ended March 31, 2011, compared to $69.6 million (73.7% of total revenue) for the corresponding period of the preceding fiscal year. In the European Union, total revenue was $20.7 million (18.5% of total revenue) for the three-month period ended March 31, 2011, compared to $16.8 million (17.8% of total revenue) for the corresponding period of the preceding fiscal year. In Canada, total revenue was $8.3 million (7.5% of total revenue) for the three-month period ended March 31, 2011, compared to $7.9 million (8.4% of total revenue) for the corresponding period of the preceding fiscal year. Total revenue in the United States was $140.6 million (71.2% of total revenue) for the six-month period ended March 31, 2011 compared to $154.8 million (75.7% of total revenue) for the corresponding period of the preceding fiscal year. In the European Union, total revenue was $38.2 million (19.4% of total revenue) for the six-month period ended March 31, 2011, compared to $32.6 million (15.9% of total revenue) for the corresponding period of the preceding fiscal year. In Canada, total revenue was $18.5 million (9.4% of total revenue) for the six-month period ended March 31, 2011, compared to $16.7 million (8.2% of total revenue) for the corresponding period of the preceding fiscal year.
Unapproved pancreatic enzyme products (“PEPs”) event
As previously disclosed, we ceased distributing our ULTRASE MT and VIOKASE product lines in the U.S. effective April 28, 2010. ULTRASE MT and VIOKASE had accounted for approximately 19% of our total net sales in the last three fiscal years ended September 30, 2009.
This action was taken as we did not receive FDA approval for ULTRASE MT or VIOKASE by April 28, 2010, the date mandated by the FDA to obtain approval for pancreatic enzyme products. We also interrupted shipments of product from the United States to Canada and export markets to allow time for the U.S. Food and Drug Administration to review our request confirming that applicable export requirements were being met as the FDA does not currently allow any shipment of this product within the U.S. As of March 31, 2011, this interruption of shipments was still in place.
We completed the initial submission of our NDA for ULTRASE MT and, in the fourth quarter of fiscal 2008, received a first complete response letter from the FDA. Further to the filing of our response to this letter, we received a second complete response letter from the FDA in the fourth quarter of fiscal 2009. On May 5, 2010 the FDA issued an additional complete response with respect to our NDA for ULTRASE MT. As was the case with prior letters, the FDA requires that deficiencies raised with respect to the manufacturing and control processes at the manufacturer of the active ingredient of ULTRASE MT be addressed before approval can be granted. We have submitted our response to this letter to the FDA that confirmed a November 28, 2010 Prescription Drug User Fee Act, or PDUFA, date for our ULTRASE MT NDA.
The submission of our rolling NDA for VIOKASE was completed in the first quarter of fiscal year 2010. At the time we completed this submission, we requested a priority review and the FDA advised us in the second quarter of fiscal year 2010 that it would not grant a priority review for this NDA. The initial PDUFA date for VIOKASE was August 30, 2010. In August 2010, we received feedback from the FDA regarding the timeline to review the VIOKASE NDA. At that time, the FDA indicated that the review was progressing but postponed the PDUFA date to November 30, 2010, to allow more time to complete their review.
On November 28, 2010, the FDA issued complete response letters regarding the NDAs for ULTRASE MT and VIOKASE. The letters require that unresolved deficiencies raised with respect to the manufacturing and control processes at the manufacturer of the active ingredient for both ULTRASE MT and VIOKASE be addressed before approval can be granted. The letters also require that deficiencies identified in an FDA inspection of such manufacturer must be resolved before the NDAs can be approved. Based on information available to the Company, on or about January 20, 2010, the manufacturer of the active pharmaceutical ingredient to ULTRASE MT and VIOKASE received a warning letter from the FDA noting that certain deficiencies previously identified by the FDA in an inspection of such manufacturer have not yet been resolved. Failure by the manufacturer to promptly correct these violations may result in further regulatory action against the manufacturer.
We are in ongoing discussions with the FDA and continue to work with the manufacturer of the active pharmaceutical ingredient to address the remaining open issues identified by the FDA. However, those remaining issues do not require additional clinical studies.
As a result of taking steps to cease distribution of ULTRASE MT and VIOKASE and in accordance with U.S. GAAP, we recorded an additional $23.4 million sales deduction reserve for the fiscal year ended September 30, 2010. This additional reserve was an estimate of our liability for ULTRASE MT and VIOKASE that may be returned by the original purchaser under our DSAs or applicable return policies as well as other incremental sales deductions that may be incurred in addition to those previously recorded for ULTRASE MT and VIOKASE prior to the PEPs event. The cease distribution order issued by the FDA was not considered as a product recall. This reserve was based on management estimates of ULTRASE MT and VIOKASE inventory in the distribution channel, assumptions on related expiration dates of this inventory as well as estimated erosion of ULTRASE MT and VIOKASE demand, based on competition from approved PEPs and the resulting estimated sell-through of ULTRASE MT and VIOKASE, actual return activity and other factors.

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The reserves that we have taken as a result of having ceased distribution of our PEPs reflect many subjective estimates that were required to be made by management. These estimates include:
a)   The quantity and expiration dates of PEPs inventory in the distribution channel;
 
b)   Short-term prescription demand during the period of time during which the products continued to be available at the pharmacy level;
 
c)   Other factors.
The reserve related to the PEPs event, was $5.3 million as at March 31, 2011, ($11.0 million as at September 30, 2010). This reserve includes a reversal of $3.7 million in the quarter-ended March 31, 2011 to reflect the estimated sales value of the remaining inventory in the distribution channel as at March 31, 2011. In future periods, we will continue to monitor and review the assumptions and estimates and will prospectively record changes to the PEPs reserve.
Financial highlights
                 
    March 31,     September 30,  
(in millions of U.S. dollars)   2011     2010  
 
    $       $  
Total assets
    1,292.1       713.2  
Long-term debt (a)
    981.1       594.5  
Shareholders’ equity (deficiency)
    63.5       (21.0 )
 
 
(a)   Including the current portion
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     three-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
(in millions of U.S. dollars)   2011     2010     2011     2010  
 
    $       $       $       $  
Total revenue
    111.4       94.4       197.3       204.5  
EBITDA (1)
    (27.6 )     (111.8 )     4.6       (69.8 )
Adjusted EBITDA (1)
    35.9       50.0       72.7       96.2  
Net loss
    (71.7 )     (163.7 )     (70.2 )     (154.3 )
 

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(1)   A reconciliation of net income to EBITDA (a non-U.S. GAAP measure) and from EBITDA to Adjusted EBITDA (a non-U.S. GAAP measure) for the three-month and six-month periods ended March 31, 2011 and 2010 are as follows:
                                 
    For the     For the     For the     For the  
    three-month     three-month     six-month     six-month  
    period ended     period ended     period ended     period ended  
    March 31,     March 31,     March 31,     March 31,  
(in millions of U.S. dollars)   2011     2010     2011     2010  
 
    $       $       $       $  
Net loss
    (71.7 )     (163.7 )     (70.2 )     (154.3 )
Financial expenses
    30.2       16.3       46.4       32.5  
Interest income
    (0.1 )     (0.2 )     (0.3 )     (0.3 )
Income tax expense (benefit)
    (4.4 )     21.8       (3.3 )     21.6  
Depreciation and amortization
    18.4       14.0       32.0       30.7  
 
EBITDA h)
    (27.6 )     (111.8 )     4.6       (69.8 )
Transaction, integration, refinancing costs and other payments to third parties a)
    21.0       2.6       24.3       4.4  
Management fees b)
    0.8       1.0       1.6       1.9  
Stock-based compensation expense excluding impact of the unapproved PEPs event c)
    5.3       2.5       5.8       4.0  
Preliminary impairment of intangible assets and goodwill related to the unapproved PEPs event d)
          107.2             107.2  
Adjustments related to the unapproved PEPs event e)
    (3.7 )     48.5       (3.7 )     48.5  
Loss on extinguishment of debt
    28.3             28.3        
Loss on disposal of product line f)
    7.4             7.4        
Inventory stepped-up value expenses g)
    4.4             4.4        
 
Adjusted EBITDA h)
    35.9       50.0       72.7       96.2  
 
 
a)   Represents transaction, integration, restructuring and refinancing costs as well as due diligence costs related to the Eurand Acquisition as well as to certain other business development projects, non-recurring transactions, payments to third parties in respect of research and development milestones and other progress payments as defined within our credit agreement.
 
b)   Represents management fees and other charges associated with the Management Services Agreement with TPG.
 
c)   Represents stock-based employee compensation expense under U.S. GAAP guidance.
 
d)   Intangible assets and goodwill write-downs related to the unapproved PEPs event.
 
e)   Adjustments and other write-downs related to the unapproved PEPs event, including a reduction of $3.7 million to the sales returns reserve during the three-month and six-month periods ended March 31, 2011 (additional returns provision of $10.4 million, inventory write-down of $28.1 million, accrual for purchases and other materials and supply commitments of $14.9 million and a stock-based compensation recovery of $4.9 million during the three-month and six-month periods ended March 31, 2010).
 
f)   Loss resulting from the disposal of the PHOTOFRIN/PHOTOBARR product line.
 
g)   As part of the purchase price allocation for Eurand Acquisition, the book value of inventory acquired was stepped up to fair value by $18.7 million as at Acquisition date. The stepped-up value is recorded as charge to cost of goods sold as acquired inventory is sold, until acquired inventory will be sold off.
 
h)   EBITDA and Adjusted EBITDA are both non-U.S. GAAP financial measures and are presented in this report because our management considers them important supplemental measures of our performance and believes that they are frequently used by interested parties in the evaluation of companies in the industry. EBITDA, as we use it, is net income before financial expenses, interest income, income taxes and depreciation and amortization. We believe that the presentation of EBITDA enhances an investor’s understanding of our financial performance. We believe that EBITDA is a useful financial metric to assess our operating performance from period to period by excluding certain items that we believe are not representative of our core business. The term EBITDA is not defined under U.S. GAAP, and EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA, as we use it, is EBITDA adjusted to exclude certain non-cash charges, unusual or non-recurring items and other adjustments set forth below. Adjusted EBITDA is calculated in the same manner as “EBITDA” and “Consolidated EBITDA” as those terms are defined under the indentures governing our notes and Credit Facility further described in the section “Liquidity and Capital Resources-Long-term Debt and New Senior Secured Credit Facility”, except that in calculating Adjusted EBITDA, we do not include certain additional adjustments under the indenture and the Credit Facility that permit us to increase “EBITDA” and “Consolidated EBITDA” by including projected cost savings and synergies calculated on a pro forma basis that we expect to realize in future periods related to actions already taken or expected to be taken within twelve months of the end of the applicable period, including the Eurand Acquisition and related initiatives. We believe that the inclusion of supplementary adjustments applied to EBITDA in presenting Adjusted EBITDA are appropriate to provide additional information to investors about certain material non-cash items and unusual or non-recurring items that we do not expect to continue in the future and to provide additional information with respect to our ability to meet our future debt service and to comply with various covenants in our indentures and Credit Facility. Adjusted EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. EBITDA and Adjusted EBITDA have limitations as an analytical tool, and they should not be considered in isolation, or as substitutes for analysis of our results as reported under U.S. GAAP. Some of these limitations are:

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    EBITDA and Adjusted EBITDA do not reflect all cash expenditures, future requirements for capital expenditures, or contractual commitments;
 
    EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, working capital needs;
 
    EBITDA and Adjusted EBITDA do not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt;
 
    Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect any cash requirements for such replacements;
 
    Adjusted EBITDA reflects additional adjustments as provided in the indentures governing our secured and unsecured notes and new senior secured credit facilities; and
 
    Other companies in our industry may calculate EBITDA and Adjusted EBITDA differently than we do, limiting its usefulness as a comparative measure.
Because of these limitations, EBITDA and Adjusted EBITDA should not be considered as measures of discretionary cash available to us to invest in our business. Our management compensates for these limitations by relying primarily on the U.S. GAAP results and using EBITDA and Adjusted EBITDA as supplemental information.

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Overview of results of operations
                                 
    For the     For the        
    three-month     three-month        
    period ended     period ended        
    March 31,     March 31,        
(in millions of U.S. dollars)   2011 2010   Change  
    $     $     $     %  
Net product sales
    109.8       94.4       15.4       16.3  
Development fees
    0.6             0.6        
Royalties
    1.0             1.0        
 
Total revenue
    111.4       94.4       17.0       18.0  
 
Cost of goods sold a) b)
    31.9       68.2       (36.3 )     (53.2 )
Selling and administration expenses a) b)
    38.9       28.4       10.5       36.9  
Management fees
    0.8       1.0       (0.2 )     (20.0 )
Research and development expenses a)
    10.9       7.7       3.2       41.6  
Other Research and development expenses attributable to development fees a)
    0.9             0.9        
Loss on disposal of product line
    7.4             7.4        
Depreciation and amortization
    18.4       14.0       4.4       31.4  
Transaction, restructuring and integration costs
    19.3             19.3        
Impairment of intangible assets and goodwill b)
          107.2       (107.2 )     (100.0 )
 
Total operating expenses
    128.5       226.5       (98.0 )     (43.3 )
 
Operating income (loss)
    (17.1 )     (132.1 )     115.0       87.1  
 
Financial expenses
    30.2       16.3       13.9       85.3  
Loss on extinguishment of debt
    28.3             28.3        
Interest income
    (0.1 )     (0.2 )     0.1       50.0  
Other income
          (7.7 )     7.7       100.0  
Loss (gain) on foreign currencies
    0.6       1.4       (0.8 )     (57.1 )
 
Total other expenses
    59.0       9.8       49.2       502.0  
 
Income (loss) before income taxes
    (76.1 )     (141.9 )     65.8       46.4  
Income taxes expense (benefit) b)
    (4.4 )     21.8       (26.2 )     (120.2 )
 
Net income (loss)
    (71.7 )     (163.7 )     92.0       56.2  
 
 
a)   Exclusive of depreciation and amortization
 
b)   Including one time charges related to the unapproved PEPs event

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    For the     For the        
    six-month     six-month        
    period ended     period ended        
    March 31,     March 31,        
(in millions of U.S. dollars)   2011     2010     Change  
    $     $     $     %  
Net product sales b)
    195.7       204.5       (8.8 )     (4.3 )
Development fees
    0.6             0.6        
Royalties
    1.0             1.0        
 
Total revenue
    197.3       204.5       (7.2 )     (3.5 )
 
Cost of goods sold a) b)
    49.3       94.8       (45.5 )     (48.0 )
Selling and administration expenses a) b)
    64.1       60.6       3.5       5.8  
Management fees
    1.6       1.9       (0.3 )     (15.8 )
Research and development expenses a)
    17.9       16.1       1.8       11.2  
Other Research and development expenses attributable to development fees a)
    0.9             0.9        
Loss on disposal of product line
    7.4             7.4        
Depreciation and amortization
    32.0       30.7       1.3       4.2  
Transaction, restructuring and integration costs
    22.3             22.3        
Impairment of intangible assets and goodwill b)
          107.2       (107.2 )     (100.0 )
 
Total operating expenses
    195.5       311.3       (115.8 )     (37.2 )
 
Operating income (loss)
    1.8       (106.8 )     108.6       101.7  
 
Financial expenses
    46.4       32.5       13.9       42.8  
Loss on extinguishment of debt
    28.3             28.3        
Interest income
    (0.3 )     (0.3 )            
Other income
          (7.7 )     7.7       100.0  
Loss (gain) on foreign currencies
    0.9       1.4       (0.5 )     (35.7 )
 
Total other expenses
    75.3       25.9       49.4       190.7  
 
Income (loss) before income taxes
    (73.5 )     (132.7 )     59.2       44.6  
Income taxes expense (benefit) b)
    (3.3 )     21.6       (24.9 )     (115.3 )
 
Net income (loss)
    (70.2 )     (154.3 )     84.1       54.5  
 
 
a)   Exclusive of depreciation and amortization
 
b)   Including one time charges related to the unapproved PEPs event
Net product sales
Net product sales in the U.S. amounted to $80.9 million for the three-month period ended March 31, 2011, compared to $69.6 million for the corresponding period of the preceding fiscal year, an increase of $11.3 million (16.2%) and $139.2 million for the six-month period ended March 31, 2011, compared to $154.8 million for the corresponding period of the preceding fiscal year, a decrease of $15.6 million (10.1%). For the three-month period, the increase in sales in U.S. is due to the inclusion of post-acquisition sales of legacy Eurand products ($19.1 million), higher sales volume of Carafate products ($6.6 million) and the favourable impact of the sales returns reserve related to the PEPs event ($14.1 million), partially offset by the absence of Ultrase and Viokase product sales ($29.3 million). For the six-month period, the decrease in net products sales is due to the absence of Ultrase and Viokase product sales ($59.9 million) partially offset by the favourable impact of the sales returns related to the PEPs event (additional provision amounting to $10.4 million during the three-month period ended March 31, 2010 and reversal of $3.7 million during the three-month period ended March 31, 2011), higher sales volume of Carafate products ($10.8 million) and by the increase related to the inclusion of post-acquisition sales of legacy Eurand products ($19.1 million).
Net product sales in the European Union increased 22.6%, to $20.6 million for the three-month period ended March 31, 2011, compared to $16.8 million for the corresponding period of the preceding fiscal year and increased 16.6% from $32.6 million for the six-month period ended March 31, 2010 to $38.0 million for the six-month period ended March 31, 2011. The increase is mostly due to the inclusion of post-acquisition sales of legacy Eurand products amounting to $5.1 million.
Net product sales in Canada increased 5.1%, to $8.3 million for the three-month period ended March 31, 2011, compared to $7.9 million for the corresponding period of the preceding fiscal year and increased 10.8% from $16.7 million for the six-month period ended March 31, 2010 to $18.5 million for the six-month period ended March 31, 2011. The increase in sales resulted primarily from higher sales volume of SALOFALK.

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Net product sales are stated net of deductions for product returns, chargebacks, contract rebates, DSA fees, discounts and other allowances. The following table summarizes our gross-to-net product sales adjustments for each significant category:
                                 
    For the     For the        
    three-month     three-month        
    period ended     period ended        
    March 31,     March 31,        
(in millions of U.S. dollars)   2011     2010     Change  
    $     $     $     %  
Gross product sales
    133.3       133.7       (0.4 )     (0.3 )
 
Gross-to-net product sales adjustments
                               
Product returns
    5.0       2.8       2.2       78.6  
Product returns related to unapproved PEPs event
    (3.7 )     10.4       (14.1 )     (135.6 )
Chargebacks
    9.2       10.7       (1.5 )     (14.0 )
Contract rebates
    8.5       11.3       (2.8 )     (24.8 )
DSA fees
    2.3       1.8       0.5       27.8  
Discounts and other allowances
    2.2       2.3       (0.1 )     (4.3 )
 
Total gross-to-net product sales adjustments
    23.5       39.3       (15.8 )     (40.2 )
 
Total net product sales
    109.8       94.4       15.4       16.3  
 
                                 
    For the     For the        
    six-month     six-month        
    period ended     period ended        
    March 31,     March 31,        
(in millions of U.S. dollars)   2011     2010     Change  
    $     $     $     %  
Gross product sales
    241.1       279.0       (37.9 )     (13.6 )
 
Gross-to-net product sales adjustments
                               
Product returns
    7.9       4.1       3.8       92.7  
Product returns related to unapproved PEPs event
    (3.7 )     10.4       (14.1 )     (135.6 )
Chargebacks
    20.1       25.5       (5.4 )     (21.2 )
Contract rebates
    13.6       25.9       (12.3 )     (47.5 )
DSA fees
    3.4       3.6       (0.2 )     (5.6 )
Discounts and other allowances
    4.1       5.0       (0.9 )     (18.0 )
 
Total gross-to-net product sales adjustments
    45.4       74.5       (29.1 )     (39.1 )
 
Total net product sales
    195.7       204.5       (8.8 )     (4.3 )
 
Product returns, contract rebates, DSA fees, discounts and other allowances totalled $23.5 million (17.6% of gross product sales) for the three-month period ended March 31, 2011 and $45.4 million (18.8% of gross product sales) for the six-month period ended March 31, 2011, compared to $39.3 million (29.4% of gross product sales) and $74.5 million (26.7% of gross product sales) for the corresponding period of the preceding fiscal year.
The decrease in total deductions as a percentage of gross product sales was mainly due to the PEPs event (additional provision amounting to $10.4 million during the three-month period ended March 31, 2010 and reversal of $3.7 million during the three-month period ended March 31, 2011) and revenue related to pharmaceutical technology business acquired in the Eurand transaction that doesn’t have sales deductions. Excluding those two elements, the sales deductions would have been 22.2% during the three-month period ended March 31, 2011 and 21.3% during the six-month period ended March 31, 2011 compared to 21.6% and 22.9% for the same periods last year.

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     Affordable Care Act
The Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010, known together as the Affordable Care Act, enacted in the U.S in March 2010 contain several provisions that could impact our business.
Although many provisions of the new legislation do not take effect immediately, several provisions became effective during the fiscal year ended September 30, 2010. These include (1) an increase in the minimum Medicaid rebate to States participating in the Medicaid program on our branded prescription drugs; (2) the extension of the Medicaid rebate to Managed Care Organizations that dispense drugs to Medicaid beneficiaries; and (3) the expansion of the 340(B) Public Health Service Act drug pricing program, which provides outpatient drugs at reduced rates, to include certain children’s hospitals, free standing cancer hospitals, critical access hospitals, and rural referral centers.
In addition, beginning in 2011, the new law requires drug manufacturers to provide a 50% discount to Medicare beneficiaries for any covered prescription drugs purchased during a Medicare Part D coverage gap (i.e. the “donut hole”). Also, beginning in 2011, new fees will be assessed on all branded prescription drug manufacturers and importers. This fee will be calculated based upon each organization’s percentage share of total branded prescription drug sales to U.S. government programs (such as Medicare Parts B and D, Medicaid, Department of Veterans Affairs and Department of Defense programs and TRICARE retail pharmacy program) made during the previous fiscal year. The aggregated industry wide fee is expected to total $28 billion through 2019, ranging from $2.5 billion to $4.1 billion annually. The Internal Revenue Service, or IRS, has issued guidance for calculating preliminary fees, but there is still uncertainty as to final implementation, since the IRS has requested public comment and may make changes in response. The new law also imposes a 2.3% excise tax on sales of certain taxable medical devices that are made after December 31, 2012, including our FLUTTER mucus clearance device. Further, effective March 31, 2013, the law requires pharmaceutical, medical device, biological, and medical supply manufacturers to begin reporting to the federal government the payments they make to physicians and teaching hospitals, and physician ownership interests in those entities. The law also provides for the creation of an abbreviated regulatory pathway for FDA approval of biosimilars and interchangeable biosimilar products. While creation of the biosimilars program is authorized as of passage of the legislation in 2010, the process of creating the regulatory pathway for approval of biosimilars will likely be lengthy, and the FDA is in the process of soliciting public input.
While certain aspects of the new legislation implemented in 2010 are expected to reduce our revenues in future years, other provisions of this legislation may offset, at some level, any reduction in revenues when these provisions become effective. In future years, based on our understanding, these other provisions are expected to result in higher revenues due to an increase in the total number of patients covered by health insurance and an expectation that existing insurance coverage will provide more comprehensive consumer protections. This would include a federal subsidy for a portion of a beneficiary’s out-of-pocket cost under Medicare Part D. However, these higher revenues will be negatively impacted by the branded prescription drug manufacturers’ fee.
The impact in terms of additional reserves recorded has been $0.5 million for the three-month period ended March 31, 2011 and $2.2 million for the six-month period ended March 31, 2011 compared to $0.8 million in the three-month and the six-month periods of last year.
Development fees
For the three-month and six month periods ended March 31, 2011, development fees amounted to $0.6 million. These fees resulted from the inclusion of Eurand’s business in the post-acquisition period. Development of a new pharmaceutical formulation generally includes the following stages:
  feasibility and prototype development;
  formulation optimization and preparation of pilot clinical samples;
  scale-up, validation and preparation of clinical samples for regulatory and commercial purposes;
  clinical trials; and
  preparation of documents and regulatory filings.
The Company applies its proprietary pharmaceutical technologies in one of two ways — either to develop products on behalf of our collaborators or as internal programs. In both situations, the Company is involved in all stages of the formulation development process and performs largely the same types of work although, in general, the Company only performs clinical trials for the products we develop internally. Clinical trials for co-developed products are typically performed by our collaboration partners. For internal projects, we fund all of the development costs with a view either to out-license the product once it is fully developed and has obtained the applicable regulatory approvals, or to market it directly.
In our typical co-development contract, we generally receive development fees and milestones from our collaborators. Most of our current co-development agreements provide for us to perform development activities based on an hourly service fee. Our current co-development agreements also typically include provisions for the receipt of milestone payments upon the achievement of certain development and/or regulatory milestones including, by way of example, successful completion of development phases, successful demonstration of bioequivalence, and acceptance and approval by the applicable regulatory agencies. Milestone payments are usually structured as lump sum payments, which are due if and when we reach certain mutually agreed-upon development milestones as set forth in the agreements. In many cases, achievement of such milestone payments is based on factors that are out of our control, including, among other things, regulatory approval of the product. In addition, in many cases, decisions directly affecting the receipt of these payments are made at the sole discretion of our collaborator. Due to the structure of our co-development agreements and the inherent difficulty in predicting progress on development plans, our development fees may fluctuate significantly from quarter to quarter. In addition, development fees will fluctuate depending on the number of co-development agreements we enter into in a given year or quarter.

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Royalties
For the three-month and six month periods ended March 31, 2011, royalties amounted to $1.0 million and resulted from the inclusion of legacy Eurand’s business in the post-acquisition period. The Company earns royalty revenues from its collaborators equal to a percentage of their product sales.
Cost of goods sold
Cost of goods sold consists principally of the cost of raw materials, royalties and manufacturing. For the three-month period ended March 31, 2011, cost of goods sold decreased $36.3 million (53.2%) to $31.9 million from $68.2 million for the corresponding period of the preceding fiscal year. As a percentage of net product sales, cost of goods sold for the three-month period ended March 31, 2011, decreased compared to the corresponding period of the preceding fiscal year to 29.1% from 72.2% mostly due to the unapproved PEPs event. For the six-month period ended March 31, 2011, cost of goods sold decreased $45.5 million (48.0%) to $49.3 million from $94.8 for the corresponding period ended March 31, 2010. As a percentage of net product sales, cost of goods sold for the six-month period ended March 31, 2011 decreased compared to the corresponding period of the preceding fiscal year to 25.2% from 46.4% primarily due to provisions taken as a result of the unapproved PEPs event.
Excluding the unapproved PEPs during the three-month period ended March 31, 2011, cost of goods sold as a percentage of net product sales would have been 30.1% compared to 32.3% for the three-month period ended March 31, 2010 and 25.8% compared to 26.1% for the six-month period ended March 31, 2010. The decreases related to the unapproved PEPs event was partially offset by the additional expense associated the inventory stepped up to fair value. As part of the purchase price allocation for Eurand Acquisition, the book value of inventory acquired was stepped up to fair value by $18.7 million as at Acquisition Date. The stepped-up value is recorded as charge to cost of goods sold as acquired inventory is sold, until acquired inventory will be sold off. An amount of $4.4 million was expensed during the three-month period ended March 31, 2011.
Selling and administrative expenses
Selling and administrative expenses, on an ongoing basis, consist principally of salaries and other costs associated with our sales force and marketing activities. For the three-month period ended March 31, 2011, selling and administrative expenses increased $10.5 million (36.9%) to $38.9 million from $28.4 million for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, selling and administrative expenses increased $3.5 million (5.8%) to $64.1 million from $60.6 million for the corresponding period of the preceding fiscal year. The increases are mainly resulting from the inclusion of legacy Eurand’s business in the post-acquisition period amounting to $11.1 million and an increase in non-cash stock-based compensation expense. The increases were partially offset by a reduction of ULTRASE AND VIOKASE products marketing expenses and patient programs.
Management fees
Management fees consist of fees and other charges associated with the Management Services Agreement with TPG. For the three-month period ended March 31, 2011, management fees decreased $0.2 million (20.0%) to $0.8 million from $1.0 million for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, management fees decreased $0.3 million (15.8%) to $1.6 million from $1.9 million for the corresponding period of the preceding fiscal year.
Research and development expenses
Research and development expenses refer to internal research and development expense and consist principally of fees paid to outside parties that we use to conduct clinical studies and to submit governmental approval applications on our behalf, as well as the salaries and benefits paid to personnel involved in research and development projects. For the three-month period ended March 31, 2011, research and development expenses increased $3.2 million (41.6%) to $10.9 million, from $7.7 million for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, research and development expenses increased $1.8 million (11.2%) to $17.9 million, from $16.1 million for the corresponding period of the preceding fiscal year. The increase in research and development expenses is mainly due to the inclusion of expenses associated with Eurand activities in the post-acquisition period amounting to $2.8 million. The increase was partially offset by the reduction in expenses related to the development work on PEPs for the six-month period ended March 31, 2011.
On March 14, 2011, we entered into an agreement with a third-party to jointly develop a new combination product including Sucralfate. Under the terms of this agreement, we will pay a series of contingent and non-contingent milestone based payments. Upon commercialization of the new product, we will pay the third party to the arrangement a single digit royalty on net sales of the new product. Additionally, the Company will pay the third party a single digit royalty on net sales of Carafate, beginning on January 1, 2013, until December 31, 2019.
Other research and development expenses attributable to development fees
The Company incurs research and development expense on a number of external projects with third parties that generate development fee revenues and consist principally of personnel cost. For the three-month and six month periods ended March 31, 2011, research and development expenses attributable to development fees amounted to $0.9 million and resulting from the inclusion of expenses associated with Eurand activities in the post-acquisition period.

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Loss on disposal of product line
On March 28, 2011, we entered into a definitive agreement with Pinnacle Biologics, Inc., which acquired all global assets and rights related to PHOTOFRIN/PHOTOBARR, including inventory, for non-contingent payments amounting to $4.2 million. In addition to the non-contingent payments, additional payments shall be made to us after the achievement of certain milestones events. In addition, the Company will be paid royalties on annual net sales of PHOTOFRIN/PHOTOBARR.
During the quarter ended March 31, 2011, we recorded a loss of $7.4 million as a result of the disposal of the PHOTOFRIN/PHOTOBARR product line. Consideration for additional contingent payments to be made to the Company shall be recorded as a gain in the period in they are received.
Depreciation and amortization
Depreciation and amortization consists principally of the amortization of intangible assets with a finite life. Intangible assets include trademarks, trademark licenses and manufacturing rights. For the three-month period ended March 31, 2011, depreciation and amortization increased $4.4 million (31.4%) to $18.4 million from $14.0 million for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, depreciation and amortization increased $1.3 million (4.2%) to $32.0 million from 30.7 million for the corresponding period of the preceding fiscal year. These increases are mainly due to additional depreciation and amortization of intangible assets recognized on the acquisition of Eurand.
Transaction, restructuring and integration costs
During the six-month period ended March 31, 2011, we have expensed $11.3 million (an additional $1.1 million was expensed in the fiscal year ended September 30, 2010) of costs relating to legal, financial, valuation and accounting advisory services performed in connection with effecting the transaction with Eurand, which are included in acquisition and restructuring costs in the accompanying Statement of Condensed Consolidated Operations.
We have initiated restructuring measures in conjunction with the integration of the operations of Eurand. These measures are intended to capture synergies and generate cost savings across the Company.
Restructuring actions taken thus far include workforce reductions across the Company and other organizational changes. These reductions primarily come from the elimination of redundancies and consolidation of staff in the sales and marketing, manufacturing, research and development, and general and administrative functions, as well as from the planned closure of Eurand’s manufacturing facility in Nogent-Oise, France.
During the quarter ended March 31, 2011, we recorded a restructuring expense in the amount of $5.0 million related to planned employee termination costs. Employee termination costs are generally recorded when the actions are probable and estimable and include accrued severance benefits and health insurance continuation, many of which may be paid out during periods after termination.
The Company estimates to incur additional costs between $17.2 million and $21.3 million in connection with planned employee termination costs. The restructuring actions taken thus far are expected to be substantially completed by the end of 2012.
Through March 31, 2011, the Company has incurred integration costs of $6.0 million representing certain external, incremental costs directly related to integrating the acquired business and primarily include expenditures for consulting and systems integration.
Impairment of intangible assets and goodwill
The value of goodwill and intangible assets with an indefinite life are subject to an annual impairment test unless events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. The intangible assets with a finite life and property, plant and equipment are subject to an impairment test whenever events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. As a result of the unapproved PEPs event, we compared the carrying value of the intangible assets with a finite life affected by the unapproved PEPs event to estimated future undiscounted cash flows. The change in circumstances associated with the unapproved PEPs event also caused us to review the carrying value of our long lived intangible assets including goodwill. Based on this review, a preliminary impairment charge of $107.2 million was recorded for the three-month and six-month periods ended March 31, 2010, reflecting charges of $91.4 million for the goodwill allocated to our U.S. reporting unit and of $15.8 million related to finite life intangible assets.
Financial expenses
Financial expenses consist principally of interest and fees paid in connection with funds borrowed for acquisitions. For the three-month period ended March 31, 2011, financial expenses increased $13.9 million (85.3%) to $30.2 from $16.3 million for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, financial expenses increased $13.9 million (42.8%) to $46.4 million from $32.5 million for the corresponding period of the preceding fiscal year. For the three-month period ended March 31, 2011, financial expenses included certain one-time fees related to bridge financing and the renegotiation of our credit agreement. On February 11, 2011, we entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition as described in the Long-term debt and Credit Facility section below.

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Loss on extinguishment of debt
In conjunction with the Eurand Acquisition, the proceeds of the debt and equity financing were used to repay the outstanding term loan amounting to $125.7 million of our then existing senior secured credit facilities. Subsequent to the Eurand Acquisition, we redeemed our existing 9.25% senior secured notes of $228.0 million due 2015 at a premium of 106.938%. The difference between the net carrying value and the repayment price of the outstanding term loan and 9.25% senior secured notes was recognized as a loss on extinguishment of debt. For the three-month and six-month periods ended March 31, 2011, loss on Extinguishment of Debt amounted to $28.3 million and comprised of the write-off of the unamortized deferred financing fees, the original issuance discount and the redemption premium.
Interest income
For the three-month period ended March 31, 2011, total interest income decreased to $0.1 million from $0.2 million for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, and the six-month period ended March 31, 2010, total interest income amounted $0.3 million.
Other income
In June 2007, we initiated a lawsuit under the U.S. Lanham Act against a number of defendants alleging they falsely advertised their products to be similar or equivalent to ULTRASE® MT. During the three-month and six-month periods ended March 31, 2010, an amount of $7.7 million was paid to us pursuant to settlement arrangements entered into with the defendants in these matters.
Income taxes
For the three-month period ended March 31, 2011, income tax benefit amounted to $4.4 million compared to income tax expense of $21.8 million for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, income tax benefit amounted to $3.3 million compared to income tax expense of $21.6 million for the corresponding period of the preceding fiscal year. The effective tax rate was 5.9%, for the three-month period ended March 31, 2011, compared to minus 15.4% for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, the effective tax rate was 4.5% compared to minus 16.3% for the corresponding period of the preceding fiscal year. The effective tax rate for the three-month and six-month periods ended March 31, 2011, is affected by a number of elements, the most important being the establishment of a valuation allowance of $29.5 million during the six-month period ended March 31, 2011 against our net deferred tax assets mostly attributable to the U.S. reporting unit. If, in future periods, the deferred tax assets are determined by management to be more likely than not to be realized, the tax benefits relating to the reversal of the valuation allowance will be recorded.
The difference between our effective tax rate and the statutory income tax rate is summarized as follows:
                                 
            For the             For the  
            three-month             three-month  
            period ended             period ended  
            March 31,             March 31,  
(in millions of US dollars)     2011       2010  
    %     $     %     $  
Combined statutory rate applied to pre-tax income (loss)
    35.00       (26.6 )     35.00       (49.7 )
Increase (decrease) in taxes resulting from:
                               
Change in promulgated rates
    (0.13 )     0.1       0.07       (0.1 )
Difference with foreign tax rates
    (0.80 )     0.6       0.56       (0.8 )
Valuation allowance
    (32.21 )     24.5       (31.71 )     45.0  
Tax benefit arising from a financing structure
    6.35       (4.8 )     2.40       (3.4 )
Non-deductible items
    (2.80 )     2.1       (23.96 )     33.9  
Non-taxable items
                       
Investment tax credits
    0.89       (0.7 )     0.28       (0.4 )
State taxes
    (0.29 )     0.2       2.61       (3.6 )
Other
    (0.14 )     0.1       (0.61 )     0.9  
 
 
    5.87       (4.5 )     (15.36 )     21.8  
 

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            For the             For the  
            six-month             six-month  
            period ended             period ended  
            March 31,             March 31,  
(in millions of US dollars)     2011       2010  
    %     $     %     $  
Combined statutory rate applied to pre-tax income (loss)
    35.00       (25.7 )     35.00       (46.4 )
Increase (decrease) in taxes resulting from:
                               
Change in promulgated rates
    (0.09 )     0.1              
Difference with foreign tax rates
    0.79       (0.6 )     1.13       (1.5 )
Valuation allowance
    (40.26 )     29.5       (33.91 )     45.0  
Tax benefit arising from a financing structure
    11.63       (8.5 )     5.73       (7.6 )
Non-deductible items
    (3.44 )     2.5       (25.92 )     34.4  
Non-taxable items
                       
Investment tax credits
    1.24       (0.9 )     0.45       (0.6 )
State taxes
    (0.42 )     0.3       2.56       (3.3 )
Other
                (1.32 )     1.6  
 
 
    4.45       (3.3 )     (16.28 )     21.6  
 
Net income
For the three-month period ended March 31, 2011, net loss decreased $92.0 million (56.2%) to $71.7 million from $163.7 million for the corresponding period of the preceding fiscal year. For the six-month period ended March 31, 2011, net loss decreased $84.1 million (54.5%) to $70.2 million from net loss of $154.3 million for the corresponding period of the preceding fiscal year. The decreases in net loss are mainly due the additional charges related to the unapproved PEPs event amounting to $175.1 million in the three-month and six-month periods ended March 31, 2010. The decreases in net loss were partially offset by the loss on extinguishment of debt amounting to $28.3 million and transaction and acquisition costs amounting to $19.3 million for the three-month period and $22.3 million for the six-month period ended March 31, 2011.
Balance sheets as at March 31, 2011, and September 30, 2010
The following table summarizes balance sheet information as at March 31, 2011, compared to September 30, 2010.
                                 
    March 31,     September 30,        
(in millions of U.S. dollars)   2011     2010     Change  
    $     $     $     %  
Cash and cash equivalents
    87.3       161.5       (74.2 )     (45.9 )
Current assets
    242.4       226.7       15.7       6.9  
Total assets
    1,292.1       713.2       578.9       81.2  
Current liabilities
    144.6       111.3       33.3       29.9  
Long-term debt
    972.2       581.3       390.9       67.2  
Total liabilities
    1,228.6       734.2       494.4       67.3  
Shareholders’ equity (deficiency)
    63.5       (21.0 )     84.5       (402.4 )
Working capital
    97.8       115.4       (17.6 )     (15.3 )
Working capital decreased by $17.6 million (15.3%) to $97.8 million as at March 31, 2011, from $115.4 million as at September 30, 2010.
Total assets increased $578.9 million (81.2%) to $1,292.1 million as at March 31, 2011, from $713.2 million as at September 30, 2010. This increase was mainly due to the total assets acquired with Eurand Acquisition amounting to $693.1 million as at March 31, 2011.
Long-term debt increased $390.9 million (67.2%) to $972.2 million as at March 31, 2011, from $581.3 million as at September 30, 2010. On February 11, 2011, the Company entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition as described in the Long-term debt and Credit Facility section below.

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Liquidity and Capital Resources
Cash requirements
As at March 31, 2011, working capital was approximately $97.8 million and $115.4 million as at September 30, 2010. Cash generated from operations, is used to fund working capital, capital expenditures, milestone payments, debt service and business development activities. We regularly review product and other acquisition opportunities and may therefore require additional debt or equity financing. We cannot be certain that such additional financing, if required, will be available on acceptable terms, or at all.
On February 11, 2011 or Acquisition Date, Axcan Holdings Inc. (“Axcan Holdings”), our indirect parent, and Axcan Pharma Holding B.V. (“Axcan AcquisitionCo”), an indirect subsidiary of the Company, pursuant to a Share Purchase Agreement dated November 30, 2010 (as amended) acquired 95.6% (99.1% after giving effect to the additional shares that are guaranteed to be delivered under a notice of guaranteed delivery) of the outstanding shares of Eurand N.V. (“Eurand”) for a purchase price of $12.00 per share in cash resulting in total consideration of approximately $589.6 million for 100% of such shares. We had acquired 100% of the outstanding shares of Eurand by March 31, 2011. As a result of the acquisition, Eurand has become an indirect subsidiary. In addition, Axcan AcquisitionCo and other direct and indirect subsidiaries of the Company acquired from Eurand substantially all of Eurand’s assets, including the capital stock of Eurand’s direct and indirect U.S. and foreign subsidiaries, and transferred the capital stock of former Eurand U.S. subsidiaries to the Company.
The aggregate equity purchase price of $589.6 million plus acquisition costs (including related fees and expenses) were funded by cash equity contributions amounting to $140.0 million from affiliates of TPG Capital L.P. and certain co-investors, the proceeds from the Senior Secured Term Loan Facility (as defined below) under the Company’s amended and restated credit agreement and related security and other agreements and cash on hand from Aptalis and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147.0 million (the “Senior Secured Revolving Credit Facility”) and (ii) a $750.0 million senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”). The Company borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition.
A portion of the proceeds of the equity and debt financings, together with cash on hand of Aptalis and Eurand, were also used to repay the outstanding term loan portion amounting to $125.7 million of the Company’s existing senior secured credit facilities and to pay related fees and expenses. The remaining amount of $250.0 million of the Senior Secured Term Loan Facility was used on March 15, 2011 to redeem 100% of the Company’s existing 9.25% senior secured notes due 2015.
There are currently two rating agencies (Moody’s and Standard & Poor’s) rating AIH’s debt. These ratings are revised from time to time.
Contractual obligations and other commitments
The following table summarizes our significant contractual obligations as at March 31, 2011, and the effect such obligations are expected to have on our liquidity and cash flows in future years. This table excludes the payment of amounts already recorded on the balance sheet as current liabilities as at March 31, 2011, and certain other purchase obligations as discussed below:
                                         
            Less than                     More than 5  
(in millions of U.S. dollars)   Total     1 year     1-3 years     3-5 years     years  
    $     $     $     $     $  
Long-term debt
    986.3       8.9       16.8       250.0       710.6  
Operating leases
    5.9       2.7       3.0       0.2        
Other commitments
    3.8       2.9       0.8       0.1        
Interest on long-term debt
    445.5       76.8       155.6       163.3       49.8  
 
                             
 
    1,441.5       91.3       176.2       413.6       760.4  
 
                             
Purchase orders for raw materials, finished goods and other goods and services are not included in the above table. Management is not able to accurately determine the aggregate amount of such purchase orders that represent contractual obligations, as purchase orders may represent authorizations to purchase rather than binding agreements. For the purpose of this table, contractual obligations for the purchase of goods or services are only included in other commitments where there exist agreements that are legally binding and enforceable on us and that specify all significant terms, including: fixed or minimum quantities to be purchased; fixed, minimum or variable price provisions; and the approximate timing of the transaction. Our purchase orders are based on current needs and are fulfilled by our vendors within relatively short timetables. We do not have significant agreements for the purchase of raw materials or finished goods specifying minimum quantities or set prices that exceed our short-term expected requirements. We also enter into contracts for outsourced services; however, the obligations under these contracts are not significant and the contracts generally contain clauses allowing for cancellation without significant penalty. As milestone payments are primarily contingent upon successfully achieving clinical milestones or on receiving regulatory approval for products under development, they do not have defined maturities and therefore are not included in the above table.

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The expected timing of payment of the obligations discussed above is estimated based on current information. The timing of payments and actual amounts paid may differ depending on the timing of receipt of goods or services, or, for some obligations, changes to agreed-upon amounts.
As at March 31, 2011, we had unrecognized tax benefits of $11.7 million ($11.3 million as at September 30, 2010). Due to the nature and timing of the ultimate outcome of these uncertain tax positions, we cannot make a reasonably reliable estimate of the amount and period of related future payments. Therefore, our unrecognized tax benefits with respect to our uncertain tax positions has been excluded from the above contractual obligations table.
Long-term debt and Credit Facility
On February 11, 2011, the Company entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147.0 million (the “Senior Secured Revolving Credit Facility”) and (ii) a $750.0 million senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”).
We borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of Aptalis and Eurand, were used to repay the outstanding term loan portion amounting to $125.7 million of our existing senior secured credit facilities and to pay related fees and expenses. Following the repayment, all unamortized deferred financing fees of $2.7 million and original issuance discount of $3.2 million related to the term loan were written off and are included in loss on extinguishment of debt in the accompanying Statement of Condensed Interim Consolidated Operations. The remaining amount of $250.0 million of the Senior Secured Term Loan Facility was drawn on March 15, 2011 to redeem our existing 9.25% senior secured notes due 2015.
On February 25, 2008, the Company issued $228.0 million aggregate principal amount of its 9.25% senior secured notes (the “Senior Secured Notes”) due March 1, 2015. The Senior Secured Notes were priced at $0.98737 with a 10% yield to March 1, 2015. On March 15, 2011, $250.0 million of the Senior Secured Term Loan Facility was used to redeem 100% of the Company’s Senior Secured Notes at a redemption price of 106.938%. The aggregate redemption amount consisted of $228.0 million in aggregate principal amount, $0.8 million accrued interest and $15.8 million of redemption premium which is included in loss on extinguishment or debt in the accompanying Statement of Condensed Interim Consolidated Operations. Following the redemption all unamortized deferred financing fees of $5.0 million and original issuance discount of $1.7 million related to these notes were written off and are included in loss on extinguishment of debt in the accompanying Statement of Condensed Interim Consolidated Operations.
The Company’s Amended and Restated Senior Secured Credit Facilities totaling $897.0 million is composed of a Senior Secured Term Loan Facility amounting to $750.0 million and a Senior Secured Revolving Credit Facility totaling $147.0 million. The Senior Secured Revolving Credit Facility is comprised of $115.0 million of existing revolving credit commitments that were extended or issued on February 11, 2011 (the “ Extended Commitments”) and $32.0 million of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility. The Amended and Restated Senior Secured Credit Facilities bear interest at a variable rate composed of either (i) the highest of the federal funds rate plus 0.5%, Bank of America, N.A.’s “prime rate”, or the one month British Banker Association LIBOR rate plus 1.00%, or (ii) the British Banker Association LIBOR rate (subject to a floor) of 1.50% with respect to borrowings under the Senior Secured Revolving Credit Facility, step-downs based on the company’s consolidated total leverage ratio). The principal amount of the Senior Secured Term Loan Facility amortizes in equal quarterly installments in aggregate annual amounts equal to 1% of the original principal amount with payments beginning in fiscal year 2011. The principal amount outstanding of the loans under the Senior Secured Term Loan Facility will be due and payable on February 11, 2017. The principal amount of outstanding loans under the Senior Secured Revolving Facility will be due and payable on February 11, 2016 with respect to Extended Commitments and on February 25, 2014 with respect to Unextended Commitments.
As at March 31, 2011, $750.0 million of term loans had been issued and no amounts are currently drawn against the revolving credit facility. The term loans were priced at $0.995 with a yield to maturity of 5.6%. The credit agreement governing the Amended and Restated Senior Secured Credit Facilities requires the Company to meet certain financial covenants, beginning the quarter ending June 30, 2011. The maintenance of these financial covenants is solely with respect to the Senior Secured Revolving Credit Facility. The credit agreement governing the Amended and Restated Senior Secured Credit Facility requires the Company to prepay outstanding term loans contingent upon the occurrence of events, subject to certain exceptions, with: (1) 100% of the net cash proceeds of any incurrence of debt other than debt permitted under the credit agreement governing the Amended and Restated Senior Secured Credit Facilities, (2) commencing with the fiscal year ended September 30, 2011, 50% (which percentage will be reduced if the senior secured leverage ratio is less than a specified ratio) of the annual excess cash flow (as defined in the credit agreement governing the Senior Secured Term Loan Facility) and (3) 100% of the net cash proceeds of all non-ordinary course asset sales or other dispositions of property (including casualty events) by the Company or by its subsidiaries, subject to reinvestments rights and certain other exceptions.
Pursuant to the annual excess cash flow requirements of our credit agreement in effect prior to the Amended and Restated Senior Secured Credit Facilities, the Company was required to prepay $13.2 million of outstanding term loans in the first quarter of fiscal year 2011 ($17.6 million for the fiscal year 2009 which was paid in the first quarter of fiscal year 2010).
On May 6, 2008, the Company issued $235.0 million of 12.75% senior unsecured notes due March 1, 2016, (the “Senior Unsecured Notes”). The Senior Unsecured Notes were priced at $0.9884 with a yield to maturity of 13.16%. The Senior Unsecured Notes are subordinated to the Amended and Restated Senior Secured Credit Facilities.

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The Company may redeem some or all of the Senior Unsecured Notes prior to March 1, 2012, at a redemption price equal to 100% of the principal amount of the Senior Unsecured Notes redeemed plus a “make-whole” premium and accrued and unpaid interest. On or after March 1, 2012, the Company may redeem some or all of the Senior Unsecured Notes at the redemption prices (expressed as percentages of principal amount of the Senior Unsecured Notes to be redeemed) set forth below:
         
    Senior  
    Unsecured
Notes
 
    %  
2012
    106.375  
2013
    103.188  
2014 and thereafter
    100.000  
Operating leases
We have various long-term operating lease agreements for office space, automotive equipment and other equipment. The latest expiry date for these agreements is in 2015.
Other commitments
Other operating commitments consist primarily of amounts relating to administrative services, clinical studies and other research and development services.
Related party transactions
As at March 31, 2011, and September 30, 2010, we had a note receivable from our parent company amounting to $133.2 million. The note receivable has been recorded in the shareholders’ equity section of the consolidated balance sheet. During the three-month periods ended March 31, 2011, and March 31, 2010, we earned interest income on the note amounting to $1.9 million net of taxes amounting to $1.0 million and $3.9 million net of taxes amounting to $2.1 million for the six-month period ended March 31, 2011 and 2010. The related interest receivable from our parent company amounting to $33.1 million as at March 31, 2011, ($27.1 million as at September 30, 2010) has been recorded in the shareholder’s equity section of the consolidated balance sheet. This amount was subject to a full provision which was also recorded in the statement of shareholders’ equity. As at March 31, 2011, we have an account receivable from our parent company amounting to $0.5 million ($0.5 million as at September 30, 2010).
Pursuant to the terms of a management fee arrangement with a controlling shareholding company, we recorded charges amounting to $0.8 million and $1.6 million during the three-month and six-month periods ended March 31, 2011 ($1.0 million and 1.9 million during the three-month and six-month periods ended March 31, 2010). As at March 31, 2011, we accrued fees payable to a controlling shareholding company amounting to $0.8 million ($1.6 million as at September 30, 2010). Also, during the three-month and six-month periods ended March 31, 2011, we recorded fees from a controlling shareholding company amounting to $5.0 million of which $1.5 million was accounted for as deferred debt issue costs, $2.5 million as selling and administrative expense and $1.0 million as financing fees. As at March 31, 2011, the Company accrued fees payable to a controlling shareholding company amounting to $0.7 million ($1.6 million as at September 30, 2010).
During the six-month period ended March 31, 2010, we paid a dividend to our parent company amounting to $0.1 million to allow for the payment of certain group expenses.
Balance sheet arrangements
We do not have any transactions, arrangements and other relationships with unconsolidated entities that are likely to affect our operating results, our liquidity or capital resources. We have no special purpose or limited purpose entities that provide off-balance sheet financing, liquidity or market or credit risk support, and do not engage in leasing, hedging, research and development services, or other relationships that expose us to liability that is not reflected on the face of the condensed consolidated interim financial statements.

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Cash flows
Our cash flows from operating, investing and financing activities for the three-month periods ended March 31, 2011, and March 31, 2010 as reflected in the condensed consolidated statements of cash flows, are summarized in the following table:
                         
    For the     For the        
    three-month     three-month        
    period ended     period ended        
    March 31,     March 31,        
(in millions of U.S. dollars)   2011     2010     Change  
    $     $     $  
Net cash provided by (used by) operating activities
    (44.9 )     31.1       (76.0 )
Net cash used by investing activities
    (527.5 )     (2.3 )     (525.2 )
Net cash provided by (used by) financing activities
    507.4       (0.1 )     507.5  
Our cash flows from operating, investing and financing activities for the six-month periods ended March 31, 2011, and March 31, 2010 as reflected in the condensed consolidated statements of cash flows, are summarized in the following table:
                         
    For the     For the        
    six-month     six-month        
    period ended     period ended      
    March 31,     March 31,        
(in millions of U.S. dollars)   2011     2010     Change  
    $   $   $
Net cash provided by (used by) operating activities
    (41.2 )     59.6       (100.8 )
Net cash used by investing activities
    (528.7 )     (3.5 )     (525.2 )
Net cash provided by (used by) financing activities
    494.2       (21.3 )     515.5  
Cash flows provided by operating activities decreased $76.0 million to $44.9 million of cash used by operating activities from $31.1 million of cash provided by operating activities for the three-month period ended March 31, 2010. Cash flows provided by operating activities decreased $100.8 million to $41.2 million of cash used by operating activities from $59.6 million of cash provided by operating activities for the six-month period ended March 31, 2010. The decreases in net cash provided by operating activities are mainly due to the transaction and restructuring costs, and financing fees related to Eurand Acquisition.
Cash flows used by investing activities increased $525.2 million to $527.5 million from $2.3 million for the three-month period ended March 31, 2010. Cash flows used by investing activities increased $525.2 million to $528.7 million from $3.5 million for the six-month period ended March 31, 2010. The increases in cash flows used by investing activities are due to Eurand Acquisition.
Cash flows provided by financing activities increased $507.5 million to $507.4 million of cash provided in the three-month period ended March 31, 2011, from $0.1 million of cash used in the three-month period ended March 31, 2010. Cash flows provided by financing activities increased $515.5 million to $494.2 million of cash provided in the six-month period ended March 31, 2011, from $21.3 million of cash used in the six-month period ended March 31, 2010. On February 11, 2011, the Company entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition as described in the Long-term debt and Credit Facility section above.

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Significant accounting policies
Our consolidated financial statements are prepared in accordance with U.S. GAAP, applied on a consistent basis. Some of our critical accounting policies require the use of judgment in their application or require estimates of inherently uncertain matters. Therefore, a change in the facts and circumstances of an underlying transaction could significantly change the application of our accounting policies to that transaction, which could have an effect on our financial statements. The policies that management believes are critical and require the use of complex judgment in their application are discussed below.
Use of estimates
The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the recorded amounts of assets and liabilities and the disclosure of contingent assets and liabilities as at the date of the financial statements and also affect the recognized amounts of revenues and expenses during the fiscal year. Estimates are used when accounting for amounts recorded in connection with acquisitions, including fair value determinations of assets and liabilities. Other significant estimates and assumptions made by management include those related to the charges to be recorded in conjunction with ceasing of distributing PEPs, allowances for accounts receivable, inventories, reserves for product returns, rebates, chargebacks and DSA fees, the classification of intangible assets between finite life and indefinite life, the useful lives of long-lived assets, the expected cash flows used in evaluating long-lived assets, goodwill and investments for impairment, stock based compensation costs, pending legal settlements and the establishment of provisions for income taxes including the realizability of deferred tax assets. The estimates are made using the historical information and various other relevant factors available to management. We review all significant estimates affecting the financial statements on a recurring basis and record the effect of any adjustments when necessary. Actual results could differ from those estimates based upon future events, which could include, among other risks, changes in regulations governing the manner in which we sell our products, changes in the healthcare environment, foreign exchange and managed care consumption patterns.
The charges that we have recorded as a result of having ceased distribution of our PEPs also reflect many subjective estimates that were required to be made by management. These estimates include:
a)   The quantity and expiration dates of PEPs inventory in the distribution channel;
b)   Assumptions regarding market share growth after an eventual re-launch of our PEPs; and
c)   Other factors.
In future periods, management will monitor and review the assumptions and estimates and will prospectively record changes to provisions reflected in the current fiscal year.
Revenue recognition
Revenue is recognized when the product is delivered to our customers, provided we have not retained any significant risks of ownership or future obligations with respect to the product delivered. Provisions for sales discounts and estimates for chargebacks, managed care and Medicaid rebates, product returns and DSA fees are established as a reduction of product sales revenues at the time such revenues are recognized. These revenue reductions are established by us at the time of sale, based on historical experience adjusted to reflect known changes in the factors that impact such reserves. In certain circumstances, product returns are allowed under our policy and provisions are maintained accordingly. These revenue reductions are generally reflected as an addition to accrued liabilities. Amounts received from customers as prepayments for products to be delivered in the future are reported as deferred revenue.
The following table summarizes the activity in the accounts related to revenue reductions:
                                                         
                                            Reserves        
                                            related        
                                            to the        
    Product     Contract     Charge-     DSA     Discounts     unapproved        
(in millions of U.S. dollars)   returns     rebates     backs     fees     and other     PEPs event     Total  
 
    $       $       $       $       $       $       $  
Balance as at September 30, 2010
    13.4       6.1       8.1       1.3       0.2       11.0       40.1  
Provisions
    7.9       13.6       20.1       3.4       4.1             49.1  
Provisions related to the unapproved PEPs event
                                  (3.7 )     (3.7 )
Eurand Acquisition
    7.3       7.8       0.9       1.9       0.2             18.1  
Settlements
    (6.3 )     (13.2 )     (15.3 )     (2.3 )     (3.9 )     (2.0 )     (43.0 )
 
Balance as at March 31, 2011
    22.3       14.3       13.8       4.3       0.6       5.3       60.6  
 

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Product returns
We do not provide any form of price protection to our wholesale customers and we generally permit product returns only if the product is returned in the six months prior to and twelve months following its expiration date. Under our policy, credit for returns is issued to the original purchaser at current wholesale acquisition cost less 10%.
We estimate the proportion of recorded revenue that will result in a return by considering relevant factors, including:
  past product returns activity;
  the duration of time taken for products to be returned;
  the estimated level of inventory in the distribution channel;
  product recalls and discontinuances;
  the shelf life of products;
  the launch of new drugs or new formulations; and
  The loss of patent protection or new competition.
Our estimate of the level of inventory in the distribution channel is based on inventory data provided by wholesalers, third-party prescription data and, for some product return provisions, estimated retail pharmacy information.
Returns for new products are more difficult to estimate than for established products. For shipments made to support the commercial launch of a new product under standard terms, our estimate of sales return accruals are primarily based on the historical sales returns experience of similar products. Once sufficient historical data on actual returns of the product are available, the returns provision is based on this data and any other relevant factors as noted above.
The accrual estimation process for product returns involves in each case a number of interrelating assumptions, which vary for each combination of product and customer. Accordingly, it would not be meaningful to quantify the sensitivity to change for any individual assumption or uncertainty. However, we do not believe that the effect of uncertainties, as a whole, significantly impacts our financial condition or results of operations.
The accrued liabilities include reserves of $22.3 million as at March 31, 2011, ($13.4 million as at September 30, 2010) for estimated product returns, excluding the additional provision related to the unapproved PEPs event. The increase is due to the integration of legacy Eurand products ($7.4 million) and additional reserve for URSO product ($2.4 million).
As at March 31, 2011, the product returns reserve related to the unapproved PEPs event amounted to $5.3 million which represents primarily management’s current estimate of the balance of ULTRASE MT and VIOKASE inventory in the distribution channel. Due to the subjectivity of this estimate, we prepared various sensitivity analyses to ensure our final estimate is within a reasonable range. A change in assumptions that resulted in a 10% change in the quantity of ULTRASE MT and VIOKASE inventory in the distribution channel would have resulted in a change in the return reserve of approximately $0.5 million.
Rebates, chargebacks and other sales deduction
In the U.S., we establish and maintain reserves for amounts payable to managed care organizations, state Medicaid and other government programs for the reimbursement of portions of the retail price of prescriptions filled that are covered by these programs. We also establish and maintain reserves for amounts payable to wholesale distributors for the difference between their regular sale price and the contract price for the products sold to our contract customers.
The amounts are recognized as revenue reductions at the time of sale based on our best estimate of the product’s utilization by these managed care and state Medicaid patients and sales to our contract customers, using historical experience, the timing of payments, the level of reimbursement claims, changes in prices (both normal selling prices and statutory or negotiated prices), changes in prescription demand patterns, and the levels of inventory in the distribution channel.
Amounts payable to managed care organizations and state Medicaid programs are based on statutory or negotiated discounts to the selling price. Medicaid rebates generally increase as a percentage of the selling price over the life of the product. As it can take up to six months for information to reach the Company on actual usage of the Company’s products in managed care and Medicaid programs and on the total discounts to be reimbursed, the Company maintains reserves for amounts payable under these programs relating to sold products. We estimate the level of inventory in the distribution channels based on inventory data provided by wholesalers and third-party prescription data.
Revisions or clarification of guidelines related to state Medicaid and other government program reimbursement practices which are meant to apply to prior periods, or retrospectively, can result in changes to management’s estimates of the rebates reported in prior periods. However, since the prices of the Company’s products are fixed at the time of sale and the quantum of rebates is therefore reasonably determinable at the outset of each transaction; these factors would not impact the recording of revenues in accordance with generally accepted accounting principles.

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The accrual estimation process for managed care organizations, state Medicaid and other government programs rebates involves in each case a number of interrelating assumptions, which vary for each combination of products and programs. Accordingly, it would not be meaningful to quantify the sensitivity to change for any individual assumption or uncertainty. However, we do not believe that the effect of uncertainties, as a whole, significantly impacts the Company’s financial condition or results of operations.
Accrued liabilities include reserves of $14.3 million and $13.8 million as at March 31, 2011, ($6.1 million and $8.1 million as at September 30, 2010) for estimated contract rebates and chargebacks. The increase is mainly due to the integration of legacy Eurand products ($10.7 million) and additional reserves related to the Affordable Care Act ($2.2 million) and TRICARE ($1.6 million).
If the levels of chargebacks, fees pursuant to DSAs, managed care, Medicaid and other government rebates, product returns and discounts fluctuate significantly and/or if our estimates do not adequately reserve for these reductions of net product revenues, our reported revenue could be negatively affected.
Intangible assets and goodwill
Intangible assets with a finite life are amortized over their estimated useful lives according to the straight-line method over periods varying from 6 months to 20 years. The straight-line method of amortization is used because it reflects, in the opinion of management, the pattern in which the intangible assets with a finite life are used. In determining the useful life of intangible assets, we consider many factors including the intention of management to support the asset on a long-term basis by maintaining the level of expenditure necessary to support the asset, the use of the asset, the existence and expiration date of a patent, the existence of a generic version of, or competitor to, the product and any legal or regulatory provisions that could limit the use of the asset.
The following table summarizes the changes to the carrying value of the intangible assets and goodwill from September 30, 2010, to March 31, 2011:
                 
    Intangible        
    assets     Goodwill  
 
    $       $  
Balance as at September 30, 2010
    348.0       73.5  
Eurand Acquisition
    413.9       106.5  
Depreciation and amortization
    (26.4 )      
Disposal of intangible assets
    (10.2 )      
Foreign exchange translation adjustments
    5.7       1.7  
 
Balance as at March 31, 2011
    731.0       181.7  
 
Research and development expenses
Research and development expenses are charged to operations in the period they are incurred. The costs of intangibles that are purchased from others for a particular research and development project that have no alternative future use are expensed at the time of acquisition.
Income taxes
Income taxes are calculated using the asset and liability method. Under this method, deferred income tax assets and liabilities are recognized to account for the estimated taxes that will result from the recovery or settlement of assets and liabilities recorded at their financial statement carrying amounts. Deferred income tax assets and liabilities are measured based on enacted tax rates and laws at the date of the financial statements for the fiscal years in which the temporary differences are expected to reverse. A valuation allowance is provided for the portion of deferred tax assets that is more likely than not to remain unrealized. Adjustments to the deferred income tax asset and liability balances are recognized in net income as they occur.
We conduct business in various countries throughout the world and are subject to tax in numerous jurisdictions. As a result of our business activities, we file a significant number of tax returns that are subject to examination by various federal, state, and local tax authorities. Tax examinations are often complex as tax authorities may disagree with the treatment of items reported by us and this may require several years to resolve.
Changes in accounting standards
See Note 3 to our Condensed Interim Consolidated Financial Statements in Item 1 of Part 1 for a description of recently issued accounting standards, including our expected adoption dates and estimated effects, if any, on our results of operations, financial condition and cash flows.

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Subsequent Events
Agreements with Mpex Pharmaceuticals Inc. for the acquisition and development of Aeroquin
On April 11, 2011, Aptalis Holdings Inc. (“Aptalis Holdings”), an indirect parent company of Aptalis Holdings Inc. (the “Company”), entered into a series of agreements with Mpex Pharmaceuticals Inc. (“Mpex”) for the acquisition and development of Aeroquin™ (the “Aeroquin Transaction”), a proprietary aerosol formulation of levofloxacin, which is currently in Phase 3 clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis (CF). Under these agreements, Aptalis Holdings has an option to not acquire all of Mpex’s assets related to Aeroquin™ in a merger, with continued development of Aeroquin™ by Mpex under the terms of a Development Agreement between the parties. Prior to the merger Mpex will transfer all of its assets that are not related to Aeroquin™ to a newly formed company that will be owned primarily by current Mpex stockholders. As a result of the Aeroquin Transaction, the Company made an initial non-contingent payment of $12.0 million on April 21, 2011. Additional remaining time-based, non-contingent payments in relation with the Aeroquin Transaction amounting to $50.5 million will be paid in a number of additional installments, of which the final installment is due on November 1, 2013.
Under the terms of the Option Agreement dated April 11, 2011 among Aptalis Holdings, Mpex, and Axcan Lone Star Inc., a Delaware corporation and an indirect wholly-owned subsidiary of Aptalis Holdings and a direct wholly-owned subsidiary of the Company (“Merger Sub”), Aptalis Holdings has an option to terminate the Merger Agreement described below. This option may be exercised during a certain period of time, which period in no event will end later than August 1, 2011.
Under the terms of the Agreement and Plan of Merger dated April 11, 2011 (the “Merger Agreement”) among Aptalis Holdings, Merger Sub, Mpex and certain stockholders of Mpex who will serve as representatives of the Mpex security holders under the Merger Agreement, Merger Sub will merge with and into Mpex, with Mpex surviving (the “Surviving Company”) as an indirect wholly-owned subsidiary of Aptalis Holdings and a direct wholly-owned subsidiary of the Company (the “Merger”). Pursuant to the Merger Agreement, the aggregate merger consideration that the Mpex security holders will receive, subject to the consummation of the Merger, consists of (i) the non-contingent payments above, (ii) contingent payments of up to $195 million if certain regulatory and commercial milestones are met related to Aeroquin™, and (iii) earn-out payments based on net sales of Aeroquin™. Indemnity obligations of the Mpex security holders will be satisfied by set-off against a portion of the foregoing merger consideration payments.
Unless terminated pursuant to the Option Agreement described above, the Merger is expected to close during the third quarter of 2011. The further development of Aeroquin™ will be conducted pursuant to the terms of the Development Agreement dated April 11, 2011 among Aptalis Holdings, Merger Sub, and Mpex. Upon completion of the divestiture of assets and liabilities unrelated to Aeroquin™ (the “Divestiture”) to a newly formed company (“Spinco”), Spinco will assume all of Mpex’s obligations under the Development Agreement. Under the Development Agreement, Mpex (and after the Divestiture, Spinco) will be paid for its actual development costs of Aeroquin™ and will have primary responsibility for conducting day-to-day development activities. Aptalis Holdings and Merger Sub will have input regarding development strategy. Pursuant to the Development Agreement, on April 12, 2011 Mpex was paid $9.2 million for development expenses incurred by Mpex since November 15, 2010 and $9.4 million for estimated development costs to be incurred during the first three months of the Development Agreement. All payments under the Development Agreement, Option Agreement and Merger Agreement to Mpex or Mpex security holders, as applicable, will be made by or on behalf of Merger Sub (or after the consummation of the Merger, the Surviving Company).
Equity investment in Aptalis Holdings
Simultaneous with the execution of the Mpex agreements, Aptalis Holdings received the proceeds of a $55.0 million equity investment from funds managed by Investor Growth Capital Limited. Axcan Holdings will contribute the proceeds of the equity investment to its subsidiaries to fund a portion of the Mpex transactions and a partial repayment on the Company’s $133.2 million note receivable from its parent company.
Risk management measures undertaken to reduce exposure to interest rate fluctuations
On April 4, 2011, the Company entered into two separate pay-fixed, receive-floating interest rate swaps. The first swap has a notional amount of $331.0 million amortizing to $84.0 million by its maturity in December 2015. The first swap has a notional amount of $219.0 million and matures in December 2016. The interest rate swaps will effectively fix the Company’s interest payments on the hedged debt at 2.386% for the first swap and 3.18% (including 150 bps LIBOR floor) for the second swap, respectively, plus the appropriate margin on each debt interest period. These swaps were designated as cash flow hedges of interest rate risk.

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Item 3.   Quantitative And Qualitative Disclosure About Market Risk
For quantitative and qualitative disclosures about market risk affecting us, see “Quantitative and Qualitative Disclosure about Market Risk” in Item 7A of Part II of our Annual Report on Form 10-K for the fiscal year ended September 30, 2010, which is incorporated herein by reference. As of March 31, 2011, our exposure to market risk has not changed materially since September 30, 2010.
Item 4T.   Controls and Procedures
Evaluation of disclosure controls and procedures
We conducted an evaluation under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of March 31, 2011, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective to ensure that material information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in internal control over financial reporting
In the ordinary course of business, we routinely enhance our information systems by either upgrading our current systems or implementing new systems. During the period covered by the Quarterly Report on Form 10-Q, no change occurred in our internal controls over financial reporting during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

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PART II. OTHER INFORMATION
Item 1A.   Risk Factors
There have been no material changes from the risk factors disclosed in our Form 10-Q for the quarterly period ended December 31, 2010.
Item 5.   Other Information
Information regarding the restructuring initiatives we have undertaken as a result of our acquisition of Eurand under Note 5 in the Notes to Condensed Consolidated Financial Statements under Part I, Item 1 of this Quarterly Report on Form 10-Q is incorporated by reference herein.
Item 6.   Exhibits.
     
Exhibit No.   Exhibit
 
3.1
  Certificate of Amendment of the Certificate of Incorporation of Aptalis Pharma Inc. (f/k/a Axcan Intermediate Holdings Inc.)
 
   
31.1
  Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
   
31.2
  Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
   
32.1
  Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 
   
32.2
  Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
         
  APTALIS PHARMA INC.
 
 
Date: May 13, 2011  BY:   /s/ Steve Gannon    
    Steve Gannon   
    Senior Vice President, Finance, Chief Financial Officer and Treasurer   

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EXHIBIT INDEX
     
Exhibit No.   Exhibit
 
3.1
  Certificate of Amendment of the Certificate of Incorporation of Aptalis Pharma Inc. (f/k/a Axcan Intermediate Holdings Inc.)
 
   
31.1
  Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
   
31.2
  Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
   
32.1
  Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 
   
32.2
  Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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