UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
     

FORM 6-K
 
     
 
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
 
For the month of August 2010
 
001-33444
 
(Commission File Number)
 
     

 
Eurand N.V.
(Exact Name of Registrant as Specified in Its Charter)
 
Not Applicable
 
(Translation of registrant’s name into English)
 
Olympic Plaza
Fred. Roeskestraat 123
1076 EE Amsterdam, The Netherlands
(Address of principal corporate office)
 
     

 
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F: Form 20-F þ Form 40-F o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934: Yes o No þ
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-

 

 

Index to Form 6-K


   
Page
     
Part I
Unaudited Condensed Consolidated Financial Information
 
 
 
1
 
 
 
 
 
 
19
     

 

 


PART I. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION
 

EURAND N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands of euros)
 
   
June 30,
2010
(Unaudited)
   
December 31, 2009
(Note 2)
 
       
ASSETS
           
  Current Assets
           
Cash and cash equivalents
    20,720       16,893  
Marketable securities
    17,572       23,049  
Accounts receivable, less allowance for doubtful accounts of €431 and €436, respectively
    21,347       21,331  
Inventories, net
    19,494       15,633  
Prepaid expenses and other current assets
    10,526       9,041  
Deferred income taxes
    2,148       2,086  
Total Current Assets
    91,807       88,033  
                 
  Non-Current Assets
               
Property, plant and equipment, net of accumulated depreciation of €79,230 and €73,145 , respectively
    37,301       35,596  
Goodwill
    28,315       26,818  
Other intangible assets, net of accumulated amortization of €6,793 and €5,720, respectively
    6,353       6,288  
Deferred income taxes
    84       1,133  
Other non-current assets
    21       21  
Total Non-Current Assets
    72,074       69,856  
                 
Total Assets
    163,881       157,889  
                 

 
See accompanying notes to unaudited condensed consolidated financial statements.
 

 

 
-1-

 

EURAND N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands of euros, except share and per share amounts)
 
   
June 30,
2010
(Unaudited)
   
December 31, 2009
(Note 2)
 
       
LIABILITIES AND SHAREHOLDERS’ EQUITY
           
  Current Liabilities
           
Current portion of long-term debt from banks
    1,000       -  
Short-term borrowings
    -       207  
Accounts payable
    8,353       12,628  
Income taxes payable
    3,240       3,260  
Accrued expenses and other current liabilities
    24,112       20,158  
Total Current Liabilities
    36,705       36,253  
                 
  Non-Current Liabilities
               
Long-term debt from banks
    2,000       -  
Employees severance indemnities
    3,864       3,932  
Other non-current liabilities
    3,523       3,192  
Deferred income taxes
    6,176       2,938  
Total Non-Current Liabilities
    15,563       10,062  
                 
Commitments and contingencies (Note 11)
               
                 
 Shareholders' Equity
               
Ordinary shares, par value €0.01 (130,000,000 shares authorized and 47,943,296 and 47,856,976  shares issued and outstanding as of June 30, 2010 and December 31, 2009, respectively)
    479       479  
Additional paid-in capital
    152,472       150,976  
Accumulated deficit
    (47,299 )     (44,286 )
Accumulated other comprehensive income
    5,961       4,405  
Total Shareholders' Equity
    111,613       111,574  
 Total Liabilities and Shareholders' Equity
    163,881       157,889  

 
See accompanying notes to unaudited condensed consolidated financial statements.
 

 
-2-

 


 

 
EURAND N.V.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands of euros, except share and per share amounts)
 
   
For the three months ended
   
For the six months ended
 
   
June 30,
2010
   
June 30,
2009
   
June 30,
2010
   
June 30,
2009
 
Product sales
    29,441       24,095       56,287       48,098  
Royalties
    1,839       2,445       4,647       5,298  
Development fees
    1,641       4,010       3,062       6,312  
Revenues
    32,921       30,550       63,996       59,708  
 
Cost of goods sold
    (15,624 )     (15,565 )     (28,379 )     (29,810 )
Research and development expenses attributable to development fees
    (1,240 )     (2,211 )     (2,472 )     (3,823 )
Other research and development expenses
    (4,401 )     (3,173 )     (8,469 )     (7,900 )
Selling, general and administrative costs
    (14,168 )     (8,492 )     (25,096 )     (16,650 )
Amortization of intangibles
    (311 )     (347 )     (618 )     (702 )
Other income (expenses)
    35       -       (471 )     -  
Operating income (loss)
    (2,788 )     762       (1,509 )     823  
                                 
Interest income (expense), net
    (12 )     75       5       128  
Foreign exchange gain (loss), net
    -       (353 )     512       (297 )
                                 
Income (loss) before taxes
    (2,800 )     484       (992 )     654  
                                 
Income tax expense
    (573 )     (1,086 )     (2,021 )     (2,230 )
                                 
Net loss
    (3,373 )     (602 )     (3,013 )     (1,576 )
                                 
Net loss per share:
                               
Basic and diluted net loss per share
    (0.07 )     (0.01 )     (0.06 )     (0.03 )
Weighted average shares used to compute basic and diluted net loss per share
    47,907,205       45,754,727       47,885,957       45,753,725  

 
See accompanying notes to unaudited condensed consolidated financial statements.

 

 
 

 
-3-

 


EURAND N.V.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
Six months ended June 30, 2010 and 2009
 (In thousands of euros, except share amounts)

 
                           
Accumulated
       
               
Additional
         
Other
   
Total
 
   
Common Stock
   
Paid-In
   
Accumulated
   
Comprehensive
   
Shareholders'
 
   
Shares
   
Amount
   
Capital
   
Deficit
   
Income
   
Equity
 
                                     
As at December 31, 2008
    45,751,997       458       134,643       (38,382 )     5,383       102,102  
Comprehensive loss:
                                               
 Net loss
                            (1,576 )             (1,576 )
 Cumulative exchange translation adjustment
                                    (456 )     (456 )
Comprehensive loss
                                            (2,032 )
Stock option compensation
                    1,152                       1,152  
Exercise of stock options
    3,920       -                               -  
As at June 30, 2009
    45,755,917       458       135,795       (39,958 )     4,927       101,222  
                                                 
As at December 31, 2009
    47,856,976       479       150,976       (44,286 )     4,405       111,574  
Comprehensive loss:
                                               
 Net loss
                            (3,013 )             (3,013 )
 Cumulative exchange translation adjustment
                                    1,556       1,556  
Comprehensive loss
                                            (1,457 )
Stock option compensation
                    1,397                       1,397  
Exercise of stock options
    86,320             99                       99  
As at June 30, 2010
    47,943,296       479       152,472       (47,299 )     5,961       111,613  

See accompanying notes to unaudited condensed consolidated financial statements.

 
-4-

 


EURAND N.V.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands of euros)
 
   
For the six months ended
 
   
June 30, 2010
   
June 30, 2009
 
Operating Activities
           
Net loss
    (3,013 )     (1,576 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
               
 Depreciation
    3,048       3,511  
 Amortization
    618       702  
 Unrealized foreign exchange (gains) losses
    (1,646 )     (58 )
 Stock compensation
    1,397       1,152  
 Deferred income taxes
    1,085       21  
Changes in operating assets and liabilities:
               
 Accounts receivable, net
    1,127       (4,526 )
 Inventories, net
    (2,474 )     (1,359 )
 Prepaid expenses and other current assets
    (430 )     (1,152 )
 Other non-current assets
    -       (67 )
 Accounts payable
    (4,744 )     (1,578 )
 Accrued expenses and other current liabilities
    2,032       5,955  
 Other non-current liabilities
    (158 )     857  
 Income taxes
    (25 )     (970 )
Cash provided by (used in) operating activities
    (3,183 )     912  
                 
Investing Activities
               
Purchase of marketable securities
    (5,276 )     (6,189 )
Maturity of marketable securities
    12,585       3,832  
Losses from hedging of marketable securities
    (1,817 )     -  
Purchases of property, plant and equipment
    (1,837 )     (2,258 )
Cash provided by (used in) investing activities
    3,655       (4,615 )
                 
Financing Activities
               
Net changes in short term borrowings
    (208 )     (72 )
Exercise of stock options
    99       -  
Cash received from long-term debt from banks
    3,000       -  
Cash provided by (used in) financing activities
    2,891       (72 )
Effect of exchange rates on cash
    464       (53 )
Increase (decrease) in cash and cash equivalents
    3,827       (3,828 )
Cash and cash equivalents at beginning of period
    16,893       19,146  
Cash and cash equivalents at end of period
    20,720       15,318  

 
See accompanying notes to unaudited condensed consolidated financial statements.
 

 

 
-5-

 
EURAND N.V.
(In thousands of euros, except share and per share data)

 

1.      Company Overview
 
Eurand N.V. is a holding company formerly known as Eurand B.V., and before that, Eurand Pharmaceuticals Holdings B.V., that was incorporated in The Netherlands as a private company with limited liability in 1984 and converted into a Dutch public limited liability company by notarial deed of conversion executed November 30, 2006.  In May 2007, Eurand N.V. completed an initial public offering of its ordinary shares in the United States and its ordinary shares began trading on the NASDAQ Global Market.  Eurand N.V.’s principal executive offices are located at Olympic Plaza, Fred. Roeskestraat 123, 1076 EE Amsterdam, The Netherlands, telephone +31 20-673 2744, with operating subsidiaries organized in the United States, Italy, France and Ireland.
 
Eurand N.V. together with its subsidiaries (collectively the “Company”) is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products, utilizing proprietary pharmaceutical technologies to develop novel products that it believes will have advantages over existing products or will address unmet medical needs.  Through collaboration arrangements, the Company has applied its technologies to drug products in a range of therapeutic areas, including cardiovascular, gastrointestinal, pain, nutrition and respiratory.  The Company is developing and commercializing a portfolio of therapeutic products to address conditions associated with cystic fibrosis and gastrointestinal disorders and, which are being promoted in the United States with the Company’s own sales and marketing team.
 
2.      Basis of Presentation
 
The accompanying unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2010 and 2009, have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and Regulation S-X of the U.S. Securities and Exchange Commission (“SEC”), consistently applied. The accompanying financial statements are condensed, because certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary to fairly present the financial position, results of operations, changes in shareholders’ equity and cash flows of the interim periods presented. All such adjustments are of a normal recurring nature. The results of operations for any interim period are not necessarily indicative of results for the full financial year. The accompanying condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2009. The accounting policies applied in preparing the accompanying unaudited condensed consolidated financial statements are consistent with those for the year ended December 31, 2009, except as discussed in Adoption of Accounting Standards below.
 
The preparation of the accompanying unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. Actual results could differ materially from those estimates.
 
Adoption of Accounting Standards
 
In January 2010, the FASB issued Accounting Standard Update (“ASU”) 2010-06 for Fair Value Measurements and Disclosures (ASC 820):  Improving Disclosures about Fair Value Measurements.  This ASU requires new disclosures for transfers in and out of Level 1 and 2 and activity in Level 3; and also clarifies existing disclosures for level of disaggregation and about inputs and valuation techniques.  The changes to the ASC as a result of this update were effective for interim and annual periods beginning after December 15, 2009, except for the Level 3 disclosures, which are effective for fiscal years beginning after December 15, 2010 and for interim periods within those years; and the adoption did not have a material impact on our consolidated financial statements. For Level 3 disclosures the Company does not expect that new requirements will have a significant impact on its consolidated financial statements.

 

 
-6-

 
EURAND N.V.
(In thousands of euros, except share and per share data)

 

Recent Accounting Pronouncements
 

In October 2009, the FASB issued ASU 2009-13, Multiple-Deliverable Revenue Arrangements, which amends ASC 605, “Revenue Recognition.”  ASU 2009-13 amends the ASC to eliminate the residual method of allocation for multiple-deliverable revenue arrangements, and requires that arrangement consideration be allocated at the inception of an arrangement to all deliverables using the relative selling price method. The ASU also establishes a selling price hierarchy for determining the selling price of a deliverable, which includes: (1) vendor-specific objective evidence if available, (2) third-party evidence if vendor-specific objective evidence is not available, and (3) estimated selling price if neither vendor-specific nor third-party evidence is available. Moreover, the ASU changes separability criteria applied in identification of units of accounting, abolishing the criterion that there must be objective and reliable evidence of fair value of the undelivered item(s) for the delivered item to be a separate unit of accounting. Additionally, ASU 2009-13 expands the disclosure requirements related to a vendor's multiple-deliverable revenue arrangements. The changes to the ASC as a result of this update are effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010 (January 1, 2011 for the Company). The changes to the ASC as a result of this update also permit retrospective application for all periods presented. The Company is currently evaluating the potential impact, if any, of the adoption on its consolidated financial statements.

On 31 March 2010 FASB ratified Emerging Issues Task Force (“EITF”) Issue No. 08-9, “Milestone Method of Revenue Recognition” (Issue 08-9). The ASU resulting from Issue 08-9 amends ASC 605-28. The Task Force concluded that the milestone method is a valid application of the proportional performance model when applied to research or development arrangements. Accordingly, the consensus states that an entity can make an accounting policy election to recognize a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. The milestone method is not required and is not the only acceptable method of revenue recognition for milestone payments. The guidance in Issue 08-9 is effective for fiscal years, and interim periods within those years, beginning on or after 15 June 2010 (January 1, 2011 for the Company), and may be applied prospectively to milestones achieved after the adoption date or retrospectively for all periods presented. Early adoption is permitted provided that the revised guidance is retrospectively applied to the beginning of the year of adoption. The Company has elected not to adopt the ASU before January 1, 2011. The Company does not expect that the adoption of the ASU will have a significant impact on the consolidated financial statements of the Company.

 

 
The carrying amounts of cash and cash equivalents, net accounts receivable, net accounts payable, short term borrowings and long term debt from banks approximate their fair values as of June 30, 2010 and December 31, 2009.
 
 
As of June 30, 2010 and December 31, 2009 the Company held U.S. treasury bills and French government bonds; and U.S. treasury bills, German and French government bonds, respectively, classified as “held to maturity.” Held to maturity investments are recorded at cost, adjusted for amortization of premiums and discounts.
 
   
June 30, 2010 (unaudited)
   
December 31, 2009 (note 2)
 
   
Carrying value
   
Fair value measured at prices quoted in active markets for identical assets (Level 1)
   
Carrying value
   
Fair value measured at prices quoted in active markets for identical assets (Level 1)
 
                         
Marketable securities
    17,572       17,559       23,049       23,013  
 
For marketable securities, pricing inputs are readily observable in the market, the valuation methodology used is widely accepted by market participants, and the valuation does not require significant management discretion. Level 1 inputs include quoted prices for identical instruments and are observable.
 
Marketable securities held as of June 30, 2010 and December 31, 2009 all had contractual maturities within one year of the reporting dates.
 
4.    Derivatives
 
The Company enters into forward exchange contracts to hedge receivables and payables denominated in U.S. dollars and Swiss francs. These contracts do not meet the criteria for formal designation and documentation at hedge inception and, accordingly, they are adjusted to fair value through income. Any respective assets or liabilities resulting from the fair value valuation of forward exchange contracts are disclosed as other current assets and other current liabilities, respectively, and were immaterial as of  June 30, 2010 and December 31, 2009. The notional amounts of the forward exchange contracts to sell U.S. dollars were $18,782,000 and  $29,723,000 as of June 30, 2010 and December 31, 2009, respectively. The notional amounts of the forward exchange contracts to buy Swiss francs were CHF 3,665,000 and CHF 3,776,000 as of June 30, 2010 and December 31, 2009, respectively.  During the three months ended June 30, 2010 and 2009, the Company recognized foreign exchange gains (losses) of €(3,687) and €176, respectively, within foreign exchange gain (loss), net, in the unaudited consolidated statement of operations, related to these hedging activities. During the six months ended June 30, 2010 and 2009, the Company recognized foreign exchange losses of €5,214 and €218, respectively, within foreign exchange gain (loss), net, in the unaudited consolidated statement of operations, related to these hedging activities.
 


 
5.      Inventories, net
 
   
June 30,
2010
(unaudited)
   
December 31,
2009
(note 2)
 
             
Raw materials
    10,677       9,759  
Work in progress
    3,390       3,174  
Finished goods
    5,427       2,700  
      19,494       15,633  

 
Allowances for obsolescence of inventories were €1,750 and €1,681 as of June 30, 2010 and December 31, 2009, respectively.


 
-7-

 
EURAND N.V.
(In thousands of euros, except share and per share data)

 

6.      Prepaid Expenses and Other Current Assets
 
   
June 30,
2010
(unaudited)
   
December 31,
2009
(note 2)
 
             
Litigation settlement receivable – current portion
    4,303       3,646  
Prepayments
    3,917       2,135  
Recoverable amounts for income taxes
    1,670       1,649  
Recoverable amounts for other taxes
    387       1,053  
Deferred cost of goods sold
    249       558  
      10,526       9,041  

 
7.      Income Taxes
 
The major reconciling items between the income taxes computed at the Dutch statutory tax rate of 25.5% and the effective tax rate for the three and six months ended June 30, 2010 and 2009 are the increase in the valuation allowance recorded on net operating losses (“NOLs”) incurred by certain of our subsidiaries and the effect of Imposta Regionale sulle Attività Produttive (“IRAP tax”) in Italy.
 
The IRAP tax is an Italian regional tax on productive activities, and has a statutory rate of 3.9%. The IRAP tax base is similar to the corporate tax base, however deduction of interest and most labor costs is not permitted. The IRAP tax is not deductible for corporate tax purposes.
 
8.      Accrued Expenses and Other Current Liabilities
 
   
June 30,
2010
(unaudited)
   
December 31,
2009
(note 2)
 
             
             
Accrued employee compensation
    6,194       5,436  
Accrued expenses
    3,782       3,448  
Accrued product returns
    2,451       3,595  
Accrued rebates and chargebacks
    2,352       940  
Social security and other contributions
    1,408       1,523  
Taxes, other than income taxes
    836       898  
Deferred revenues
    7,089       4,318  
      24,112       20,158  
 

 

 
-8-

 
EURAND N.V.
(In thousands of euros, except share and per share data)

 

 
9.      Long-Term Debt from Banks
 
On June 16, 2010 the Company entered into an unsecured loan agreement with an Italian bank to borrow €3,000 repayable in installments from September 2010 through September 2013 with a variable interest of 1.6% above Euribor. Euribor interest rate is hedged by a cap of 2.5%.
 
Long-term debt from banks is as follows:
 
   
June 30,
2010
(unaudited)
   
December 31,
2009
(note 2)
 
             
             
Loan from Italian bank
    3,000       -  
      3,000       -  
                 
Amount due within one year
    (1,000 )     -  
      2,000       -  
 
10.      Shareholders’ Equity
 
Share Capital
 
During the six months ended June 30, 2010 and 2009, the Company issued 86,320 and 3,920 ordinary shares, respectively, in order to satisfy our obligations on the exercise of employee stock options.
 
Equity Based Compensation
 
Certain of our employees participate in the Eurand N.V. Equity Compensation Plan (the “Plan”) for which a maximum of 12,235,224 ordinary shares have been authorized for grants of options and other share awards by us. The Plan is an amendment and restatement of the Eurand N.V. Equity Compensation Plan adopted on August 29, 2007, which in turn was an amendment and restatement of the Eurand N.V. 1999 Stock Option Plan first adopted in December 1999.
 
The criteria for measurement of option value, and consequently the commencement of the amortization of the expense, were met for 870,250 and 254,000 options, respectively, during the six months ended June 30, 2010 and 2009.
 
11.      Commitments and Contingencies
 
We are involved in legal proceedings arising in the normal course of business. Management believes that, based on advice of legal counsel and currently available information, the outcome of these proceedings will not have a material adverse effect on our consolidated financial statements.
 


 
-9-

 
EURAND N.V.
(In thousands of euros, except share and per share data)

 

12.      Per Share Information
 

In accordance with ASC Topic 260, “Earnings per Share,” the Company has reported both basic and diluted net loss per share. The computation of diluted net loss per share did not assume the effect of shares issuable upon the exercise of stock options as their effects are anti-dilutive. Averages of non-dilutive stock options are as follows:
 
   
For the three months ended
 
For the six months ended
 
   
June 30, 2009
(unaudited)
   
June 30, 2009
(unaudited)
   
June 30, 2010
(unaudited)
   
June 30, 2009
(unaudited)
 
                         
Average of non-dilutive stock options
    4,522,136       3,840,096       4,205,679       3,852,356  

 
13.      Geographic Revenues
 
Revenues based on the country in which the recipient of the product or service is resident, are as follows:
 
   
For the three months ended
   
For the six months ended
 
   
June 30, 2010 (unaudited)
   
June 30, 2009 (unaudited)
   
June 30, 2010 (unaudited)
   
June 30, 2009 (unaudited)
 
                         
U.S.A
    23,151       16,814       43,542       32,894  
Germany
    2,709       3,062       6,496       6,040  
United Kingdom
    1,708       2,382       3,841       4,827  
Japan
    1,074       1,394       1,893       2,527  
Italy
    943       1,269       1,592       2,686  
Spain
    329       1,037       779       1,459  
Switzerland
    1,253       915       1,271       2,262  
Canada
    308       804       703       1,206  
France
    553       545       1,006       1,461  
Netherlands
    34       471       474       1,080  
Other
    859       1,857       2,399       3,266  
      32,921       30,550       63,996       59,708  

 

 

 
-10-

 


 
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
 
You should read the following discussion and analysis in conjunction with our unaudited condensed consolidated financial statements and the related notes to our unaudited condensed consolidated financial statements and the other financial information appearing elsewhere in this report.  Except for historical information contained herein, this discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from the results discussed below. Accordingly, investors should not place undue reliance upon our forward-looking statements.
 
Forward Looking Statements
 
The forward-looking statements are contained primarily in the section entitled “Operating and Financial Review and Prospects”. All statements in this document that are not statements of historical fact are forward looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements. These statements are based upon management’s current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. In addition to the risks and uncertainties included in this Report on Form 6-K, other factors that could cause our actual results or actual outcomes to differ materially from those expressed in or implied by such forward-looking statements include, but are not limited to:
 
·  
our ability to market, commercialize and achieve market acceptance for ZENPEP ® or any of the products that we are developing, commercializing or may develop or commercialize in the future, including the growth and establishment of specialty sales, marketing and distribution capabilities in the United States to commercialize products;
 
·  
the possibility that our competitors have introduced significant quantities of unapproved products into the market place prior to the FDA’s April 28 th , 2010 Stop Distribution date and that, for a period of time, this excess inventory will compete with sales of our approved product, ZENPEP;
 
·  
the uncertainty surrounding the timing of the U.S. Food and Drug Administration’s (FDA) approval for Axcan’s ULTRASE® MT.  The Company licenses, manufactures and supplies Ultrase capsules to Axcan and there is possibility that we may have significantly reduced PEP sales to this customer in the United States until such approval is obtained, as well as subsequent competition in the event that the product is approved;
 
·  
the expected timing, costs, progress or success of any of our preclinical and clinical development programs, regulatory approvals, or commercialization efforts;
 
·  
delays in obtaining, or a failure to obtain and maintain, regulatory approval for our product candidates;
 
·  
our ability to continue to successfully manufacture our existing products;
 
·  
the potential advantages of our products or product candidates over other existing or potential products;
 
·  
our ability to enter into any new co-development or licensing agreements or to maintain any existing co-development or licensing agreements with respect to our product candidates or products;
 
·  
our ability to effectively maintain existing licensing relationships and establish new licensing relationships;
 

 
-11-

 

·  
the expense, time and uncertainty involved in the development of our product candidates, some or all of which may never reach the regulatory approval stage;
 
·  
our reliance on collaboration partners and licensees, to obtain and maintain regulatory approval for certain of our products and product candidates, and to commercialize such products;
 
·  
our ability to compete in the pharmaceutical industry;
 
·  
our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others;
 
·  
the continuation of product sales by our collaborators and licensees;
 
·  
a loss of rights to develop and commercialize our products under our license and sublicense agreements;
 
·  
a loss of any of our key scientists or management personnel;
 
·  
our estimates of market sizes and anticipated uses of our products and product candidates;
 
·  
our estimates, and the estimates of others, including equity research analysts, of our future performance;
 
·  
and our estimates, and the estimates of others, including equity research analysts, regarding our anticipated future revenue, expenses, operating losses, capital requirements and our needs for additional financing.
 
 
Business Update
 
Marketed Product Updates
 
 
EUR-1008 – ZENPEP ® (pancrelipase) Delayed-Release Capsules
 
FDA-approved ZENPEP is a proprietary porcine-derived pancreatic enzyme replacement product, or PEP, developed to address the 2004 FDA guidance on pancreatic enzyme products (PEPs).  It has been approved for the treatment of (exocrine pancreatic insufficiency) EPI due to cystic fibrosis (CF) or other conditions.  Patients suffering from EPI are unable to produce or secrete pancreatic enzymes necessary for digestion, resulting in the malabsorption of nutrients and overall malnutrition.  EPI patients typically require PEPs which break down fats, proteins and complex carbohydrates for proper absorption into the body.  PEPs are a daily requirement for patients with EPI and are considered necessary for survival of many patients with CF.  According to data from IMS Health, PEPs generated approximately $1.3 billion in worldwide sales and approximately $403 million in U.S. sales in 2009.
 
PEPs had been commercialized in the U.S. without the benefit of FDA approval for more than 70 years.  In 2004, after significant adverse event reports, the FDA conducted a review of PEPs and found that none demonstrated “consistent bioactivity that results in predictable safety and effectiveness,” primarily as a result of lack of product stability and overfill.  As a result of these findings, the FDA mandated that all PEPs be subject to FDA review and approval and established criteria to ensure consistent quality, potency and stability of PEPs.  The FDA initially allowed certain manufacturers to continue to manufacture and sell unapproved PEPs until April 28, 2008.  However, in October 2007 the FDA extended the deadline to April 28, 2010.
 
 
We launched ZENPEP ® (pancrelipase) Delayed-Release Capsules, a treatment for pancreatic insufficiency, in November 2009. In mid-December 2009, we introduced PANCRELIPASE™, an authorized generic (AG) to the 5000 unit dose of ZENPEP.  The AG is intended to retain the market share which the unbranded Pancrelipase captured in 2009 in the low-dose segment of the gastroenterology market. This market has historically has moved to the lowest-cost product.
 

 
-12-

 

 
In addition to receiving five years of regulatory exclusivity as a new chemical entity (NCE), we have filed a number of patent applications that include claims intended to provide market exclusivity for certain commercial aspects of ZENPEP.  On February 9, 2010, the U.S. Patent and Trademark Office issued U.S. Patent No. 7,658,918, entitled "STABLE DIGESTIVE ENZYME COMPOSITIONS".  We expect that this patent will provide us with patent coverage on ZENPEP until at least February 20, 2028.
 
We are marketing ZENPEP to the approximately 120 CF Centers across the U.S. through our own sales force of 16 sales representatives and to the gastrointestinal market segment primarily through a contract sales organization of 49 sales representatives.
 
Based on publicly available materials and our industry knowledge, we are aware of two other PEP manufacturers that filed and have pending NDAs for a PEP and two (Solvay/Abbott and Johnson & Johnson) who have received FDA approval. In 2009 two PEPs received FDA approval, Creon ® from Solvay/Abbott and ZENPEP.  In April 2010 McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, announced FDA approval for Pancreaze™, its reformulated PEP, formerly marketed as Pancrease.
 
 
ZENPEP Launch Update
 
For the week ended July 23, 2010, our total ZENPEP franchise (ZENPEP and the AG) held 15% of total prescriptions in the PEP market.  This represents an increase of 9 points or 150%  when compared with a 6% share of total prescriptions as of April 23, 2010.
 
In late March 2010, the FDA, in accordance with its previously stated guidance that all marketed PEPs were required to have FDA approval by April 28, 2010, declared this a Stop Distribution date for unapproved PEPs and advised that patients not currently taking an approved product begin working with their healthcare professionals to switch to an FDA-approved PEP. On April 29, 2010, the Centers for Medicare & Medicaid Services (CMS) announced that, effective immediately, certain unapproved PEPs would no longer be reimbursed.
 
 
On May 6, 2010, Axcan announced that the FDA issued a complete response letter regarding Axcan’s New Drug Application (NDA) for its coated PEP, ULTRASE ® MT.  This letter requires that deficiencies 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 (Eurand is not the manufacturer of the active ingredient).  The FDA has not requested any new clinical studies.  Axcan has stated publicly that they are working closely with the FDA to address outstanding questions and are confident that ULTRASE ® MT will receive NDA approval, but cannot give any guidance at this point as to when approval will occur.
 
 
In accordance with the FDA's guidance, Axcan has stated that they stopped distribution of Ultrase effective April 28, 2010.  We license, manufacture and supply Ultrase capsules to Axcan and also receive royalties based on a percentage of Axcan’s net sales of the finished product. Both in 2009 and in the three months ended March 31, 2010, revenues from product sales and royalties to Axcan in the United States accounted for 31% of our total revenues.  In the second quarter of 2010 our revenues from Ultrase decreased substantially compared with the second quarter of 2009 and the first quarter of 2010, and accounted for 19% of our total revenues.  However, sales of ZENPEP in the second quarter 2010 more than offset lower product sales and royalties from Axcan for Ultrase, compared with the second quarter of 2009.
 
 
The ULTRASE ® MT product, if approved, would compete with ZENPEP.  As there are currently only three approved products for the PEP market (ZENPEP, Creon ® by Solvay/Abbott and Pancreaze™ by Johnson & Johnson) as long as Axcan's ULTRASE ® MT and VIOKASE ® products remain unapproved, an opportunity is presented for ZENPEP, or the other approved PEPs, to capture an additional share of the PEP market.  Pending FDA approval and launch, we anticipate lower product sales and royalties from Axcan for Ultrase in the second half of 2010 compared with the first half, but we expect that, compared with the second half of 2009, the revenue decrease due to Ultrase should be more than offset by increasing ZENPEP franchise revenues.
 

 
-13-

 

Product Development Pipeline Updates
 
 
EUR-1008 – ZENPEP ® (pancrelipase) Delayed-Release Capsules
 
 
In late 2009, the European Medicines Agency (EMA) finalized its draft guidelines on the clinical development and evaluation of medicinal products, including PEPs, for the treatment of cystic fibrosis.  Based on these guidelines and the feedback we received from the EMA on the clinical and regulatory path forward for EUR-1008 (ZENPEP), we anticipate initiating a Phase III study in Europe in the second half of 2010.
 
 
The EMA has deemed a ZENPEP marketing authorization application eligible for evaluation of the under the Centralized Procedure, which enables a single marketing authorization that is valid across the European Union and provides the potential for 10 years of marketing exclusivity once the product is approved.  We believe that ZENPEP could be the first product to be filed under the Centralized Procedure since the EMA guidelines were issued.
 
 
We intend to out-license the distribution rights for EUR-1008 in Europe and Asia and discussions are ongoing with potential partners in those regions.
 
 
EUR-1025 – Once-Daily Formulation of Ondansetron
 
 
Following a meeting with the FDA in late 2009, we submitted a protocol to the FDA for two Phase III studies evaluating EUR-1025, a proprietary once-a-day oral modified-release formulation of ondansetron, in the prevention of nausea and vomiting.  The FDA recently provided its response, and Eurand is incorporating this feedback into the protocol design. 
 
 
EUR-1073 – CLIPPER™ (beclomethasone dipropionate)
 
 
Chiesi Farmaceutici S.p.A., the licensor of EUR-1073, a corticosteroid for the treatment of ulcerative colitis, completed a Phase IIIb clinical study in Europe comparing CLIPPER™ to the current standard of care, prednisolone, in ulcerative colitis. Following a thorough analysis of the data from this study, Eurand has decided to discontinue development of this product and return the rights to Chiesi at no cost to Eurand.

 
 

 

Presentation of Financial information
 
We prepared our financial statements included in this report in euros in accordance with U.S. GAAP. References to “U.S. dollars,” “dollars,” “U.S. $” or “$” in this report are to the currency of the United States and references to “euro”, “(euro)” or “€“ are to the single currency of the European Union.
 
Exchange Rate Information
 
Fluctuations in the exchange rates between the euro and the dollar will affect the dollar amounts received by owners of our shares on payment of dividends, if any, paid in euros. Moreover, such fluctuations may also affect the dollar price of our shares on the NASDAQ Global Market.
 

 
-14-

 

The following table sets forth information regarding the exchange rates of U.S. dollar per euro for the periods indicated. Average rates are calculated by using the average of the closing noon buying rates on each day during the periods presented.
 
   
High
   
Low
   
Average
   
Period End
 
                         
Three months ended
                       
March 31, 2009
    1.3946       1.2547       1.3035       1.3261  
June 30, 2009
    1.4270       1.2903       1.3619       1.4020  
September 30, 2009
    1.4795       1.3852       1.4311       1.4630  
December 31, 2009
    1.5100       1.4243       1.4762       1.4332  
March 31, 2010
    1.4536       1.3344       1.3820       1.3526  
June 30, 2010
    1.3666       1.1959       1.2740       1.2291  
                                 
    Six months ended June 30,
                               
2009
    1.4270       1.2547       1.3334       1.4020  
2010
    1.4536       1.1959       1.3267       1.2291  
                                 
Month in 2010
                               
January
    1.4536       1.3870       1.4266       1.3870  
February
    1.3955       1.3476       1.3675       1.3660  
March
    1.3758       1.3344       1.3570       1.3526  
April
    1.3666       1.3130       1.3417       1.3302  
May
    1.3183       1.2224       1.2563       1.2369  
June
    1.2385       1.1959       1.2223       1.2291  
July
    1.3069       1.2464       1.2811       1.3069  

Results of Operations
 
This section discusses our operating results.

 
Three months ended June 30, 2010, compared to three months ended June 30, 2009
 
 

 
The following table shows how revenues for the three months ended June 30, 2010 changed compared to the same period in 2009.

   
Three months ended June 30,
 
   
2010
   
2009
   
Increase (decrease) compared to previous period
 
   
(euros in thousands, except percentages)
 
Product sales
    29,441       24,095       5,346       22 %
Royalty income
    1,839       2,445       (606 )     -25 %
Development fees
    1,641       4,010       (2,369 )     -59 %
Total revenues
    32,921       30,550       2,371       8 %


 
-15-

 

Revenues. Our total revenues were €32.9  million for the three months ended June 30, 2010, compared to €30.6  million for the same period in 2009, an increase of €2.4  million or approximately 8%. The increase was primarily due to sales of ZENPEP and its AG (Authorized Generic), Pancrelipase TM , which we sell in the U.S. market and were launched at the end of 2009. This growth would have been 0.9 million, approximately 3%, if we excluded the effect of currency exchange rates variances.

Our product sales were €29.4  million for the three months ended June 30, 2010, an increase of €5.3  million or approximately 22% compared to the same period in 2009.  The increase was due to sales of ZENPEP which more than offset lower sales of ULTRASE to Axcan and no revenues from our low cost pancrelipase product which generated significant sales in 2009. The increase in product sales growth would have been €4.1  million or approximately 17% if currency effects worth €1.2  million were excluded.
 
 
Our royalties were €1.8  million for the three months ended June 30, 2010, a decrease of €0.6  million or approximately 25%, due to a decrease in royalties from ULTRASE of Axcan.  This decrease would have been 0.7 million or 29% if the currency effects were excluded. Pending FDA approval and launch, we anticipate substantially lower product royalties from ULTRASE of Axcan in the subsequent periods.

Our development fees were €1.6 million for the three months ended June 30, 2010 compared to €4.0  million for the same period in 2009, a decrease of €2.4  million, or approximately 59%.  If the currency exchange rate effect were excluded the decrease would have been 62% or €2.5  million.  Development fees may fluctuate significantly from quarter to quarter depending on when certain milestone fees are earned and during the same period of 2009 included milestone revenue from GSK related to the launch of LAMICTAL ODT.

Cost of Goods Sold. Our cost of goods sold was €15.6  million for the three months ended June 30, 2010 compared to €15.6  million for the same period in 2009.  If negative foreign exchange effects of approximately €0.6  million were excluded, cost of goods sold would have decreased by €0.6  million or approximately 4% compared to the previous year. During the second quarter of 2010 we sold some inventories of ZENPEP that had been expensed in previous periods before in the third quarter of 2009 we received a regulatory approval for commercial launch in the U.S. If the related inventories were not expensed in previous periods cost of goods sold in the three months ended June 30, 2010 would have been higher by approximately €0.4 million.

Cost of goods sold as a percentage of product sales was 53.1% compared to 64.6% in the same period of 2009 and is primarily the result of the increase in higher margin ZENPEP product sales.

Research and Development Expenses. Research and development expenses were €5.6  million for the three months ended June 30, 2010 compared to €5 .4 million for the same period in 2009, representing an increase of €0.3  million, or approximately 5%.  If foreign exchange rate effects were excluded, total R&D expense would have increased by €0 .1 million, approximately 1%.  We classify our research and development expenses into two categories, research and development expenses attributable to development fees and other research and development expenses.

Research and Development Expenses Attributable to Development Fees . For the three months ended June 30, 2010, we were involved in a number of external projects for third parties, which we classify in our consolidated statement of operations as research and development expenses attributable to development fees. For the three months ended June 30, 2010, we incurred €1.2 million in research and development expenses attributable to development fees, representing 22% of our total research and development expenses. This represented a decrease of €1.0 million compared to the same period in 2009. The largest component of these research and development expenses attributable to development fees was personnel costs. For the three months ended June 30, 2010, €0.6 million of personnel costs were incurred compared to €0.7 million for the same period in 2009. With more than 10 active external projects during the three months ended June 30, 2010 and 2009, no single project was individually significant.
 
Other Research and Development Expenses. In our consolidated statement of operations, we refer to internal research and development expenses as other research and development expenses. For the three months ended June 30, 2010, we incurred €4.4 million in other research and development expenses, representing 78% of our total research and development expenses. This represented an increase of €1.2 million compared to the same period in 2009. Certain components of our other research and development expenses, notably clinical study activity, can

 
-16-

 

significantly vary from quarter to quarter. Both for the three months ended June 30, 2010 and 2009, the only internal project that was individually significant with respect to our total research and development expenses was ZENPEP® (EUR-1008). In the three months ended June 30, 2010 development costs for EUR-1008 were €1.7 million and €1.5 million in the same period in 2009. For the three months ended June 30, 2010 and 2009, the portion of our research and development expenses attributable to other internal development projects was €2.7 million and €1.7 million, respectively, and was comprised of multiple projects, none of which was individually significant in relation to our total research and development expenses.

Selling, General and Administrative Expenses. Selling, general and administrative expenses were €14.2 million for the three months ended June 30, 2010 compared to €8.5  million for the same period in 2009, representing an increase of €5.7 million, ap proximately 67% or €4.9 million, approximately 58% if the currency effects were excluded.  This is primarily attributable to an increase in direct sales and marketing expenses associated with the launch of ZENPEP, the expansion of the sales force, and related marketing, patient support and managed care programs.

Income tax expense. For the three months ended June 30, 2010, we recorded income taxes of €573 thousand on a pre-tax loss of €2.8 million .  In the three months ended June 30, 2009, we recorded income taxes of approximately €1 .1 million on a pre-tax income of €484 thousand .  Our taxes do not correlate directly to our consolidated profit and loss before tax for two main reasons.  First, we are subject to certain local income taxes in Italy for which most labor and financial costs are non-deductible.  Second, we have recorded valuation allowances to reduce deferred tax assets and withholding taxes recoverable in certain operating subsidiaries that are not generating taxable profits on a recurring basis to amounts that are deemed more likely than not to be recovered. Additionally in the second quarter 2010, due to revisions to our estimates of revenues from product sales and royalties from ULTRASE of Axcan, we revised and increased our estimated annual effective tax rate applied to the income of our Italian subsidiary. The effect of this revision, which was applied to income before taxes for the first half of 2010, was fully recorded in income tax expense in the second quarter of 2010.
 
 
Six months ended June 30, 2010, compared to six months ended June 30, 2009
 
The following table shows how revenues for the six months ended June 30, 2010 changed compared to the same period in 2009.

   
Six months ended June 30,
 
   
2010
   
2009
   
Increase (decrease) compared to previous period
 
   
(euros in thousands, except percentages)
 
Product sales
    56,287       48,098       8,189       17 %
Royalty income
    4,647       5,298       (651 )     -12 %
Development fees
    3,062       6,312       (3,250 )     -52 %
Total revenues
    63,996       59,708       4,288       7 %


Revenues. Our total revenues were €64 .0 million for the six months ended June 30, 2010, compared to €59.7  million for the same period in 2009, an increase of €4.3  million or approximately 7%. The increase was primarily due to sales of ZENPEP and its AG (Authorized Generic), Pancrelipase TM , which we sell in the U.S. market and were launched at the end of 2009. This growth was not affected by changes in exchange rates.


 
-17-

 

 
 
Our royalties were €4.6  million for the six months ended June 30, 2010, a decrease of €0.7  million or approximately 12%, due to a decrease in royalties from ULTRASE of Axcan. This decrease would have been 0.6 million or 11% if the currency effects were excluded. Pending FDA approval and launch, we anticipate substantially lower product royalties from ULTRASE of Axcan in the subsequent periods.

Our development fees were €3.1 million for the six months ended June 30, 2010 compared to €6.3  million for the same period in 2009, a decrease of €3.2  million, or approximately 52%.  The currency exchange rate had no significant impact on the development fees. Development fees may fluctuate significantly from quarter to quarter depending on when certain milestone fees are earned and for the first six months of 2009 included a milestone payment from GSK related to the launch of LAMICTAL ODT.

Cost of Goods Sold. Our cost of goods sold was 28.4 million for the six months ended June 30, 2010 compared to 29.8 million for the same period in 2009, representing a decrease of €1.4  million, or approximately 5%.  If foreign exchange effects of approximately €0.3  million were excluded then the decrease would have been approximately €1 .7 million or 6%, compared to the previous year. During the first half of 2010 we sold some inventories of ZENPEP that were expensed in previous periods before in the third quarter of 2009 we received a regulatory approval for commercial launch in the U.S. If the related inventories were not expensed in previous periods cost of goods sold in the six months ended June 30, 2010 would have been higher by approximately €0.5 million.

Cost of goods sold as a percentage of product sales was 50.4% compared to 62.0% in the same period of 2009 primarily as result of the increase in higher margin ZENPEP product sales.

Research and Development Expenses. Research and development expenses were 10.9 million for the six months ended June 30, 2010 compared to €11 .7 million for the same period in 2009, representing a decrease of €0.8  million, or approximately 7%.  Foreign exchange rate effects have not had any significant impact and would show the same decrease if the currency effects were excluded.  We classify our research and development expenses into two categories, research and development expenses attributable to development fees and other research and development expenses.

Research and Development Expenses Attributable to Development Fees . For the six months ended June 30, 2010, we were involved in a number of external projects for third parties, which we classify in our consolidated statement of operations as research and development expenses attributable to development fees. For the six months ended June 30, 2010, we incurred €2.5 million in research and development expenses attributable to development fees, representing 23% of our total research and development expenses. This represented a decrease of €1.4 million compared to the same period in 2009. The largest component of these research and development expenses attributable to development fees was personnel costs. For the six months ended June 30, 2010, €0.9 million of personnel costs were incurred compared to €1.3 million for the same period in 2009. With more than 10 active external projects during the six months ended June 30, 2010 and 2009, no single project was individually significant.
 
Other Research and Development Expenses. In our consolidated statement of operations, we refer to internal research and development expenses as other research and development expenses. For the six months ended June 30, 2010, we incurred €8.5 million in other research and development expenses, representing 77% of our total research and development expenses. This represented an increase of €0.6 million compared to the same period in 2009. Certain components of our other research and development expenses, notably clinical study activity, can significantly vary from quarter to quarter. Both for the six months ended June 30, 2010 and 2009, the only internal project that was individually significant with respect to our total research and development expenses was ZENPEP® (EUR-1008). In the six months ended June 30, 2010 development costs for EUR-1008 were €2.9 million and €3.4 million in the same period in 2009. For the six months ended June 30, 2010 and 2009, the portion of our research and development expenses attributable to other internal development projects was €5.6 million and €4.5 million,

 
-18-

 

respectively, and was comprised of multiple projects, none of which was individually significant in relation to our total research and development expenses.

Selling, General and Administrative Expenses. Selling, general and administrative expenses were €25.1 million for the six months ended June 30, 2010 compared to 16.7 million for the same period in 2009, representing an increase of €8.4 million, ap proximately 51% or 8.1 million, approximately 49% if the currency effects were excluded.  This is primarily attributable to an increase in direct sales and marketing expenses associated with the launch of ZENPEP, the expansion of the sales force, and related marketing, patient support and managed care programs.

 
Income tax expense. For the six months ended June 30, 2010, we recorded income taxes of 2.0 million on a pre-tax loss of €992 thousand .  In the six months ended June 30, 2009, we recorded income taxes of approximately €2 .2 million on a pre-tax income of €654 thousand .  Our taxes do not correlate directly to our consolidated profit and loss before tax for two main reasons.  First, we are subject to certain local income taxes in Italy for which most labor and financial costs are non-deductible.  Second, we have recorded valuation allowances to reduce deferred tax assets and withholding taxes recoverable in certain operating subsidiaries that are not generating taxable profits on a recurring basis to amounts that are deemed more likely than not to be recovered.
 

Changes in Financial Position
 
Cash and cash equivalents . Cash and cash equivalents were €20.7 million as of June 30, 2010 compared to €16.9 million as of December 31, 2009. Our cash and cash equivalents increased primarily due to cash received on maturity of marketable securities of €12.6 million and cash received from long-term bank borrowings of €3.0 million, which more than offset purchase of marketable securities of €5.3 million, cash used in operating activities in the period of €3.2 million and investments in property, plant and equipment of €1.8 million.
 
Marketable securities . Marketable securities were €17.6 million as of June 30, 2010 compared to €23.0 million as of December 31, 2009.
 
Total shareholders’ equity . Shareholders’ equity on June 30, 2010 did not change from December 31, 2009 and was €111.6 million, primarily as a result of the following offsetting equity changes: a net loss of €3.0 million, the effects of share-based compensation of €1.4 million and a positive exchange translation adjustment of €1.6 million.
 
Off Balance Sheet Arrangements
 
As of June 30, 2010, we did not have any off balance sheet arrangements.
 
 
Exchange Rate Risk
 
Our European operations use the euro as the functional currency, and our U.S. operations use the U.S. dollar as the functional currency. We express our consolidated financial statements in euros. Our European operations transact business in euros primarily with European customers, with the notable exception of Axcan, our largest customer. Our U.S. operations transact business in U.S. dollars primarily with U.S. customers. We recognize the cumulative effect of foreign currency translations as a separate component of shareholders’ equity.
 

A hypothetical 10% appreciation in currency exchange rates against the U.S. dollar from the prevailing market rates would have increased our pre-tax loss by approximately €874 thousand for the six months ended June 30, 2010. Conversely, a hypothetical 10% depreciation in currency exchange rates against the U.S. dollar from the prevailing market rates would have decreased our pre-tax loss by approximately €1.1 million for the six months ended June 30, 2010.
 

 
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Impact of Inflation
 
We do not believe that inflation has had a material effect on our business, results of operations or financial condition for any of the periods discussed or that inflation will affect us to a different extent than it affects the general economy.
 
 

PART II. OTHER INFORMATION
 
Risk Factors
 
There have been no material changes from the risk factors set forth in the Company's quarterly report on Form 6-K for the quarter ended March 31, 2010.
 

 
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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.

                Date: August 6, 2010

 
EURAND N.V.
 
(Registrant)
   
 
By:
/s/Mario Crovetto
   
Mario Crovetto
   
Chief Financial Officer


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