form10q.htm


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

FORM 10-Q

x  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934

for the quarterly period ended September 30, 2009

OR
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 1-10638

CAMBREX CORPORATION
(Exact name of registrant as specified in its charter)

DELAWARE
22-2476135
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)

ONE MEADOWLANDS PLAZA, EAST RUTHERFORD, NEW JERSEY 07073
(Address of principal executive offices)

(201) 804-3000
(Registrant's telephone number, including area code)

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 twelve 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 ý.   No o.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer.  See definition of “accelerated filer and large accelerated filer”in Rule 12b-2 of the Exchange Act.  (Check one):

Large accelerated filer o
Accelerated filer ý
Non-accelerated filer o
Smaller reporting company o
(Do not check if a smaller reporting company)

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes o.   No ý.
 
As of October 31, 2009, there were 29,285,406 shares outstanding of the registrant’s Common Stock, $.10 par value.
 


 
 

 

CAMBREX CORPORATION AND SUBSIDIARIES

Form 10-Q

For The Quarter Ended September 30, 2009
Table of Contents
 
     
Page No.
Part I
Financial information
 
       
 
Item 1.
 
       
   
2
       
   
3
       
   
4
       
   
5 - 19
       
 
Item 2.
20 - 26
       
 
Item 3.
27
       
 
Item 4.
27
       
Part II
Other information
 
       
 
Item 1.
28
       
 
Item 1A.
28-35
       
 
Item 6.
36
       
37

 


Part I - FINANCIAL INFORMATION

Item 1.
Financial Statements

CAMBREX CORPORATION AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share data)

   
September 30,
   
December 31,
 
   
2009
   
2008
 
   
(unaudited)
       
ASSETS
           
Current assets:
           
Cash and cash equivalents
  $ 45,345     $ 32,540  
Trade receivables, net
    37,466       36,685  
Inventories, net
    61,341       61,133  
Prepaid expenses and other current assets
    9,193       8,798  
Total current assets
    153,345       139,156  
                 
Property, plant and equipment, net
    166,303       161,500  
Goodwill
    36,838       35,374  
Other non-current assets
    4,661       5,042  
                 
Total assets
  $ 361,147     $ 341,072  
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current liabilities:
               
Accounts payable
  $ 16,167     $ 19,700  
Accrued expense and other current liabilities
    35,566       45,080  
Total current liabilities
    51,733       64,780  
                 
Long-term debt
    124,000       123,800  
Deferred income tax
    17,774       16,138  
Accrued pension and postretirement benefits
    45,707       44,165  
Other non-current liabilities
    16,537       17,403  
Total liabilities
    255,751       266,286  
                 
Stockholders' equity:
               
                 
Common stock, $.10 par value; authorized 100,000,000, issued 31,406,778 shares at respective dates
    3,140       3,140  
Additional paid-in capital
    100,132       99,881  
Retained earnings
    25,113       11,960  
Treasury stock, at cost, 2,129,361 and 2,224,613 shares at respective dates
    (18,177 )     (19,014 )
Accumulated other comprehensive loss
    (4,812 )     (21,181 )
                 
Total stockholders' equity
    105,396       74,786  
                 
Total liabilities and stockholders' equity
  $ 361,147     $ 341,072  
 
See accompanying notes to unaudited consolidated financial statements.

2


CAMBREX CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations
(unaudited)
(in thousands, except per-share data)

   
Three months ended
   
Nine months ended
 
   
September 30,
   
September 30,
 
   
2009
   
2008
   
2009
   
2008
 
                         
Gross sales
  $ 57,802     $ 56,508     $ 177,568     $ 184,440  
Allowances and rebates
    285       193       623       1,137  
Net sales
    57,517       56,315       176,945       183,303  
Other revenues
    (1,147 )     1,977       (262 )     1,792  
Net revenues
    56,370       58,292       176,683       185,095  
Cost of goods sold
    39,422       42,057       120,919       127,120  
Gross profit
    16,948       16,235       55,764       57,975  
Operating expenses:
                               
Selling, general and administrative expenses
    9,295       8,767       26,889       31,511  
Research and development expenses
    2,026       1,772       5,924       5,945  
Restructuring expenses
    -       321       -       1,469  
Strategic alternative costs
    -       833       -       1,408  
Total operating expenses
    11,321       11,693       32,813       40,333  
                                 
Operating profit
    5,627       4,542       22,951       17,642  
                                 
Other expenses/(income):
                               
Interest expense, net
    1,111       956       3,410       2,302  
Other (income)/expenses, net
    (31 )     485       (139 )     459  
                                 
Income before income taxes
    4,547       3,101       19,680       14,881  
                                 
Provision for income taxes
    1,584       304       6,520       6,002  
Net income
  $ 2,963     $ 2,797     $ 13,160     $ 8,879  
                                 
                                 
Earnings per share of common stock:
                               
Basic
  $ 0.10     $ 0.10     $ 0.45     $ 0.31  
Diluted
  $ 0.10     $ 0.10     $ 0.45     $ 0.31  
                                 
Weighted average shares outstanding:
                               
Basic
    29,253       29,163       29,225       29,096  
Effect of dilutive stock based compensation
    50       15       24       5  
Diluted
    29,303       29,178       29,249       29,101  

See accompanying notes to unaudited consolidated financial statements.

3


CAMBREX CORPORATION AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
 
   
Nine months ended
 
   
September 30,
 
   
2009
   
2008
 
Cash flows from operating activities:
           
Net income
  $ 13,160     $ 8,879  
Adjustments to reconcile net income to cash flows:
               
Depreciation and amortization
    14,774       16,115  
Increase in inventory reserve
    2,514       3,763  
Stock based compensation included in net income
    988       1,665  
Other
    90       1,034  
Changes in assets and liabilities:
               
Trade receivables
    833       17,102  
Inventories
    135       (14,975 )
Prepaid expenses and other current assets
    (518 )     (237 )
Accounts payable and other current liabilities
    (12,450 )     (33,203 )
Other non-current assets and liabilities
    30       (3,045 )
Net cash provided by/(used in) operating activities
    19,556       (2,902 )
                 
Cash flows from investing activities:
               
Capital expenditures
    (9,651 )     (22,908 )
Acquisition of business, net of cash
    -       (1,284 )
Other investing activities
    57       -  
Net cash used in investing activities
    (9,594 )     (24,192 )
                 
Cash flows from financing activities:
               
Long-term debt activity (including current portion):
               
Borrowings
    19,700       55,800  
Repayments
    (19,500 )     (36,416 )
Other financing activities
    (44 )     44  
Net cash provided by financing activities
    156       19,428  
Effect of exchange rate changes on cash and cash equivalents
    2,687       (1,649 )
Net increase/(decrease) in cash and cash equivalents
    12,805       (9,315 )
Cash and cash equivalents at beginning of period
    32,540       38,488  
Cash and cash equivalents at end of period
  $ 45,345     $ 29,173  
 
See accompanying notes to unaudited consolidated financial statements.

4


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements
(dollars in thousands, except share data)

(1)
Basis of Presentation

Unless otherwise indicated by the context, "Cambrex" or the "Company" means Cambrex Corporation and subsidiaries.

The accompanying unaudited consolidated financial statements have been prepared from the records of the Company.  In the opinion of management, the financial statements include all adjustments, which are of a normal and recurring nature, except as otherwise described herein, and are necessary for a fair statement of financial position and results of operations in conformity with generally accepted accounting principles (“GAAP”).  These interim financial statements should be read in conjunction with the financial statements for the year ended December 31, 2008.

The results of operations for the three and nine months ended September 30, 2009 are not necessarily indicative of the results expected for the full year.

(2)
Impact of Recently Issued Accounting Pronouncements

Fair Value Measurements

The Company adopted the Financial Accounting Standards Board’s (“FASB”) Statement “Fair Value Measurements” related to nonfinancial assets and nonfinancial liabilities effective January 1, 2009.  This statement defines fair value, establishes a framework for measuring fair value in GAAP, and expands disclosures about fair value measurements.  This statement applies whenever another standard requires (or permits) assets or liabilities to be measured at fair value.   The standard does not expand the use of fair value to any new circumstances.  The effect of adopting this pronouncement did not have a material impact on the Company’s financial position or results of operations.

Disclosures about Derivative Instruments and Hedging Activities

The Company adopted the FASB’s Statement “Disclosures about Derivative Instruments and Hedging Activities” effective January 1, 2009.  This statement requires enhanced disclosures about derivative and hedging activities and thereby improves the transparency of financial reporting.  This statement also encourages, but does not require, comparative disclosures for earlier periods at initial adoption.  The effect of adopting this pronouncement did not have an impact on the Company’s financial position or results of operations.

Employers’ Disclosures about Postretirement Benefit Plan Assets

In December 2008, the FASB issued “Employers’ Disclosures about Postretirement Benefit Plan Assets.”  This statement provides guidance on additional disclosures about plan assets of a defined benefit pension or other postretirement plan.  This statement is effective for fiscal years ending after December 15, 2009.  Upon initial application, the provisions of this pronouncement are not required for earlier periods that are presented for comparative purposes. The Company is currently evaluating the disclosure requirements of this new statement.

5


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(2)
Impact of Recently Issued Accounting Pronouncements (continued)

Subsequent Events

The Company adopted the FASB’s Statement “Subsequent Events” effective June 30, 2009.  This statement establishes general standards of accounting for, and disclosure of, events that occur after the balance sheet date but before financial statements are issued or are available to be issued.  This statement requires the disclosure of the date through which an entity has evaluated subsequent events and the basis for that date, that is, whether that date represents the date the financial statements were issued or were available to be issued.  The effect of adopting this pronouncement did not have a material impact on the Company’s financial position or results of operations.

FASB Accounting Standards Codification and the Hierarchy of GAAP

The Company adopted the FASB’s Statement “The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles” effective September 30, 2009.  This statement provides for the FASB Accounting Standards Codification to become the single official source of authoritative, nongovernmental U.S. GAAP.  This statement does not change GAAP but reorganizes the literature.

Measuring Liabilities at Fair Value

In August 2009, the FASB issued “Fair Value Measurements and Disclosures —Measuring Liabilities at Fair Value.”  This update provides amendments to “Fair Value Measurements and Disclosures – Overall”, for the fair value measurement of liabilities.  This update provides clarification for circumstances in which a quoted price in an active market for the identical liability is not available, how to estimate the fair value of a liability and how to determine the quoted price.  The amendments in this update reduce potential ambiguity in financial reporting when measuring the fair value of liabilities.  This update is effective for the first reporting period beginning after issuance.  The Company is currently evaluating the potential impact of this update.

Revenue Arrangements with Multiple Deliverables

In September 2009, the Emerging Issues Task Force (“EITF”) issued “Revenue Arrangements with Multiple Deliverables.”  This issue addresses how to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting, and how to allocate the consideration to each unit of accounting.  This issue will supersede EITF 00-21 “Revenue Arrangements with Multiple Deliverables.”  This issue eliminates the use of the residual value method for determining allocation of arrangement consideration; and allows the use of an entity's best estimate to determine the selling price if vendor specific objective evidence and third-party evidence can not be determined.  This issue also requires additional disclosure to provide both qualitative and quantitative information regarding the significant judgments made in applying this issue.  In addition, for each reporting period in the initial year of adoption, this issue requires disclosure of the amount of revenue recognized subject to the measurement requirements of this issue and the amount of revenue that would have been recognized if the related transactions were subject to the measurement requirements of Issue 00-21.  This issue is effective for revenue arrangements entered into or materially modified in fiscal years beginning after June 15, 2010.  Early adoption is permitted.  The Company is currently evaluating the potential impact of this issue.

6


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(3)
Stock Based Compensation

The Company recognizes compensation costs for stock option awards to employees based on their grant-date fair value.  The value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model.  The weighted-average fair value per share for stock options granted to employees during the nine months ended September 30, 2009 and 2008 was $1.48 and $1.88, respectively.

For the three months ended September 30, 2009 and 2008, the Company recorded $104 and $129, respectively, in selling, general and administrative expenses for stock options, which, in 2008, includes $23 recorded in strategic alternative costs as a result of a modification to previous stock option awards related to a special dividend declared in 2007.  For the nine months ended September 30, 2009 and 2008, the Company recorded $416 and $434, respectively, in selling, general and administrative expenses for stock options, which in 2008, includes $136 for the acceleration of stock options previously awarded to the former CEO and $76 recorded in strategic alternative costs as a result of a modification to previous stock option awards related to a special dividend declared in 2007.  As of September 30, 2009, the total compensation cost related to unvested stock option awards granted to employees but not yet recognized was $1,219.  The cost will be amortized on a straight-line basis over the remaining weighted-average vesting period of 2.9 years.

For the three months ended September 30, 2009 and 2008, the Company recorded $135 and $208, respectively, in selling, general and administrative expenses for restricted stock awards.  For the nine months ended September 30, 2009 and 2008, the Company recorded $520 and $1,121, respectively, in selling, general and administrative expenses for restricted stock awards, which includes $461 in 2008 for the acceleration of restricted stock previously awarded to the former CEO.  As of September 30, 2009 the total compensation cost related to unvested restricted stock granted, but not yet recognized was $456.  The cost will be amortized on a straight-line basis over the remaining weighted-average vesting period of 0.9 years.

The following table is a summary of the Company’s stock option activity issued to employees and related information:

Options
 
Number of Shares
   
Weighted Average Exercise Price
 
             
Outstanding at January 1, 2009
    1,590,869     $ 14.07  
Granted
    20,000     $ 4.17  
Forfeited or expired
    (2,000 )   $ 12.97  
Outstanding at March 31, 2009
    1,608,869     $ 13.27  
Granted
    2,500     $ 2.45  
Forfeited or expired
    (52,450 )   $ 21.21  
Outstanding at June 30, 2009
    1,558,919     $ 12.98  
Forfeited or expired
    (9,550 )   $ 9.78  
Outstanding at September 30, 2009
    1,549,369     $ 13.00  
                 
Exercisable at September 30, 2009
    799,013     $ 20.29  

7


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)
 
 
(3)
Stock Based Compensation (continued)

The aggregate intrinsic value for all stock options outstanding as of September 30, 2009 was $1,200.  The aggregate intrinsic value for all stock options exercisable as of September 30, 2009 was $98.

A summary of the Company’s nonvested stock options and restricted stock as of September 30, 2009 and changes during the three and nine months ended September 30, 2009, are presented below:

   
Nonvested Stock Options
   
Nonvested Restricted Stock
 
   
Number of Shares
   
Weighted-Average Grant-Date Fair Value
   
Number of Shares
   
Weighted-Average Grant-Date Fair Value
 
                         
Nonvested at January 1, 2009
    833,819     $ 5.55       143,327     $ 13.38  
Granted
    20,000     $ 4.17       16,182     $ 2.23  
Vested during period
    (375 )   $ 7.71       (31,753 )   $ 12.31  
Nonvested at March 31, 2009
    853,444     $ 5.51       127,756     $ 12.24  
Granted
    2,500     $ 2.45       8,532     $ 4.22  
Vested during period
    (65,625 )   $ 5.59       (7,596 )   $ 4.74  
Forfeited
    (875 )   $ 11.21       (655 )   $ 17.02  
Nonvested at June 30, 2009
    789,444     $ 5.49       128,037     $ 12.12  
Granted
    -       -       5,814     $ 6.20  
Vested during period
    (32,989 )   $ 11.05       (38,572 )   $ 13.35  
Forfeited
    (6,099 )   $ 6.92       (1,515 )   $ 15.45  
Nonvested at September 30, 2009
    750,356     $ 5.24       93,764     $ 11.20  
 
(4)
Goodwill

The changes in the carrying amount of goodwill for the nine months ended September 30, 2009, are as follows:

Balance as of January 1, 2009
  $ 35,374  
Translation effect
    1,464  
Balance as of September 30, 2009
  $ 36,838  
 
8


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(5)
Income Taxes

The Company recorded tax expense of $1,584 and $6,520 in the three and nine months ended September 30, 2009, respectively, compared to $304 and $6,002 in the three and nine months ended September 30, 2008, respectively.  The increase is due to changes in the geographic mix of pre-tax earnings, the enactment of reduced tax rates in Sweden and tax benefits related to the favorable resolution of certain tax matters in the three and nine months ended September 30, 2008.

The Company maintains a full valuation allowance against its domestic, and certain foreign, deferred tax assets and will continue to do so until an appropriate level of profitability is sustained or tax strategies can be developed that would enable the Company to conclude that it is more likely than not that a portion of these deferred tax assets would be realized.  As such, improvements in pre-tax income in the future, within these jurisdictions where the Company maintains a valuation allowance, may result in these tax benefits ultimately being realized.  However, there is no assurance that such improvements will be achieved.

As of January 1, 2009 the Company had approximately $1,697 of unrecognized tax benefits, excluding gross interest and penalties.  During the three and nine months ended September 30, 2009, the Company increased its unrecognized tax benefits by $61 and $178, respectively, for current year positions and foreign currency translation.  Of the total balance of unrecognized tax benefits at September 30, 2009 $1,145, if recognized, would affect the effective tax rate.

In the next twelve months the Company may decrease the reserve for unrecognized tax benefits for intercompany transactions by approximately $250 mainly due to the expiration of a statute of limitation period.  This item would impact the income tax provision.

In September 2008 the Company was selected for a random IRS examination for tax year 2006.  The examination is in process and no adjustments have been proposed to date.  Tax years 2007 and forward remain open to examination within the U.S.  The Company is also subject to exams in its significant non-U.S. jurisdictions for 2004 and 2007 forward.

The Company is also subject to audits in various states for various years in which it has filed income tax returns.  In June 2009 the Company finalized a New Jersey examination of its open tax years, with no material adjustments.  Previous state audits have resulted in immaterial adjustments.  Open years for the majority of states where the Company files are 2006 and forward.

In July 2009, the Company’s Italian subsidiary received a preliminary report from the local taxing authority related to an audit of the subsidiary’s 2006 tax return.  This report challenged the deductibility of certain intercompany transactions for 2006 and the benefits related to a transaction initiated in 2003.  In October 2009, the Company formally responded to the preliminary report. The Company expects the tax authority to either respond in the Company’s favor, or issue a formal assessment prior to December 31, 2009 based upon the merits of the Company’s response.  If the tax authority were to disagree with the Company’s position on these issues, the Company estimates an assessment, excluding penalties, could be levied against this subsidiary for up to $7,000 based upon the preliminary report.  Although it is early in the process at this time, the Company has analyzed these issues in accordance with guidance on uncertain tax positions and believes its reserves are adequate, and intends to defend itself.

9


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(5)
Income Taxes (continued)

In September 2009, the Company’s Swedish subsidiary was examined by the local taxing authority. The tax authority has questioned certain significant intercompany balances and transactions.  The Company expects to file a response to the inquiry in November 2009.  The Company expects it to take several months before a formal audit report is issued.  If the tax authority were to disagree with the Company’s position on these issues, the Company estimates the preliminary assessment would be less than $2,000. Although it is early in the process at this time, the Company has analyzed these issues in accordance with guidance on uncertain tax positions and believes its reserves are adequate, and intends to defend itself.

(6)
Net Inventories

Inventories are stated at the lower of cost, determined on a first-in, first-out basis, or market.

Net inventories at September 30, 2009 and December 31, 2008 consist of the following:
 
   
September 30,
   
December 31,
 
   
2009
   
2008
 
             
Finished goods
  $ 22,967     $ 24,657  
Work in process
    23,320       22,372  
Raw materials
    11,376       10,688  
Supplies
    3,678       3,416  
Total
  $ 61,341     $ 61,133  

(7)
Strategic Alternative Costs and Restructuring Expenses

Strategic Alternative Costs

Strategic alternative costs include expenses that the Company has incurred related to the decision to sell the businesses that comprised the Bioproducts and Biopharma segments in February 2007 and costs associated with a project to streamline the Company’s legal structure.  These costs are not considered part of either the restructuring program or discontinued operations under current accounting guidance.

Strategic alternative costs for the three and nine months ended September 30, 2008 were $833 and $1,408, respectively, consisting primarily of costs associated with the project to streamline the Company’s legal structure, change-in-control benefits, and costs associated with the modification of employee stock options due to the payment of the special dividend in connection with the divestiture discussed above.

Restructuring Expenses

Corporate Office Restructuring

During 2007, the Company announced a plan to eliminate certain employee positions at the corporate office upon completion of the sale of the businesses that comprised the Bioproducts and Biopharma segments.  This plan included certain one-time benefits for terminated employees.  Costs related to this plan are recorded as restructuring expenses in the income statement.  For the three and nine months ended September 30, 2008, the Company recognized expense of $45 and $295, respectively.

10


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(7)
Strategic Alternative Costs and Restructuring Expenses (continued)

Consolidation of Domestic Research and Development Activities

In December 2007, the Company consolidated its United States research and development (“R&D”) activities and small scale active pharmaceutical ingredient (“API”) production with its facility in Charles City, Iowa.  The restructuring reserve at December 31, 2008 consisted of the remaining lease payments and related costs under the Company’s current operating lease at the New Jersey R&D facility.  The operating lease expires in December 2010.  Costs related to this consolidation are recorded as restructuring expenses on the income statement.  For the three and nine months ended September 30, 2008 the Company recorded rent and related expenses of $276 and $1,174, respectively.

The following table reflects the activity related to the restructuring reserves through September 30, 2009:

   
December 31, 2008
   
2009 Activity
   
September 30, 2009
 
   
Reserve
         
Cash
   
Reserve
 
   
Balance
   
Expense
   
Payments
   
Balance
 
                         
Employee termination costs
  $ 462     $ -     $ (403 )   $ 59  
Lease payments and related costs
    3,021       -       (1,158 )     1,863  
Total
  $ 3,483     $ -     $ (1,561 )   $ 1,922  
 
(8)
Derivatives and Hedging Activities

The Company operates internationally and is exposed to fluctuations in foreign exchange rates and interest rates in the normal course of business.  These fluctuations can increase the costs of financing, investing and operating the business.  The Company uses derivative financial instruments to reduce these exposures to market risks resulting from fluctuations in interest rates and foreign exchange rates.

By nature, all financial instruments involve market and credit risks.  The Company is exposed to credit losses in the event of nonperformance by the counterparties to the contracts.  While there can be no assurance, the Company does not anticipate non-performance by these counterparties.

Foreign Currency Forward Contracts

The Company's policy is to enter into forward exchange contracts to hedge forecasted cash flows associated with foreign currency transaction exposures which are accounted for as cash flow hedges, as deemed appropriate.  This hedging strategy mitigates the impact of short-term foreign exchange rate movements on the Company's operating results primarily in Sweden and Italy.  The Company's primary market risk relates to exposures to foreign currency exchange rate fluctuations on transactions entered into by these international operations that are denominated primarily in U.S. dollars, Swedish krona, and euros.  As a matter of policy, the Company does not hedge to protect the translated results of foreign operations.

The Company's forward exchange contracts substantially offset gains and losses on the transactions being hedged.  The forward exchange contracts have varying maturities with none exceeding twelve months. The Company makes net settlements for forward exchange contracts at maturity, based upon negotiated rates at inception of the contracts.

11


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(8)
Derivatives and Hedging Activities (continued)

All forward contracts outstanding at September 30, 2009 have been designated as cash flow hedges and, accordingly, changes in the fair value of these derivatives are not included in earnings but are included in accumulated other comprehensive (loss)/income (“AOCI”).  Changes in the fair value of the derivative instruments reported in AOCI will be reclassified into earnings as a component of product revenue when the forecasted transaction occurs.  The ineffective portion of all hedges is recognized in current-period earnings and is immaterial to the Company's financial results.

The notional amounts of foreign exchange forward contracts were $14,795 and $20,568 at September 30, 2009 and December 31, 2008, respectively.

The fair value of the Company’s forward contracts is a gain of $172 and is located under the caption “other current assets” on the balance sheet as of September 30, 2009.

The Company recognized a pre-tax gain in other comprehensive income from foreign exchange contracts of $897 and $850 for the three and nine months ended September 30, 2009, respectively.  The Company reclassified a pre-tax loss of $342 and $446 from AOCI into other revenue related to foreign exchange forward contracts for the three and nine months ended September 30, 2009, respectively.  Assuming current market conditions continue, the entire amount recorded in AOCI related to foreign exchange forward contracts is expected to be reclassed into other revenue within the next 12 months to reflect the fixed prices obtained from the forward contracts.

Interest Rate Swap Agreements

The Company enters into interest rate swap agreements to reduce the impact of changes in interest rates on its floating rate debt.  The swap agreements are contracts to exchange floating rate for fixed interest payments periodically over the life of the agreements without the exchange of the underlying notional debt amounts.

All swap contracts outstanding at September 30, 2009 have been designated as cash flow hedges and, accordingly, changes in the fair value of derivatives are recorded each period in AOCI.  Changes in the fair value of the derivative instruments reported in AOCI will be reclassified into earnings in the period in which earnings are impacted by the variability of the cash flows of the hedged item.  The ineffective portion of all hedges is recognized in current-period earnings and is immaterial to the Company's financial results.

As of September 30, 2009, the Company had three interest rate swaps in place with an aggregate notional value of $60,000, at an average fixed rate of 4.48%, all with maturity dates of October 2010.  The Company’s strategy has been to cover a portion of its outstanding bank debt with interest rate protection.  At September 30, 2009, the coverage was approximately 48% of the Company’s variable interest rate debt.  At September 30, 2009 the Company had variable debt of $124,000, of which $60,000 is fixed by interest rate swaps.  Interest expense under these agreements, and the respective debt instruments that they hedge, are recorded at the net effective interest rate of the hedged transactions.  The fair value of these agreements was based on quoted market prices and was in a loss position of $2,559 at September 30, 2009.  This loss is reflected in the balance sheet under the caption “Accrued expense and other current liabilities.”

12


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(8)
Derivatives and Hedging Activities (continued)

The Company increased other comprehensive income by $340 and $981, respectively, related to interest rate swaps for the three and nine months ended September 30, 2009.  The Company reclassified a pre-tax loss of $643 and $1,865 from AOCI into interest expense related to interest rate swaps for the three and nine months ended September 30, 2009, respectively.  Assuming current market conditions continue, approximately $2,340 is expected to be reclassed out of AOCI into interest expense within the next 12 months.

(9)
Fair Value Measurements

U.S. GAAP establishes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2 inputs are quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets in markets that are not active, inputs other than quoted prices that are observable for the asset or liability, including interest rates, yield curves and credit risks, or inputs that are derived principally from, or corroborated by, observable market data through correlation; Level 3 inputs are unobservable inputs based on the Company’s assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement.

The following tables provide the assets and liabilities carried at fair value measured on a recurring basis as of September 30, 2009 and December 31, 2008:

         
Fair Value Measurements at September 30, 2009 using:
 
Description
 
Total
   
Quoted Prices in Active Markets for Identical Assets (Level 1)
   
Signifcant Other Observable Inputs (Level 2)
   
Significant Unobservable Inputs (Level 3)
 
Foreign currency forwards, assets
  $ 172     $ -     $ 172     $ -  
Interest rate swaps
    (2,559 )     -       (2,559 )     -  
Total
  $ (2,387 )   $ -     $ (2,387 )   $ -  

         
Fair Value Measurements at December 31, 2008 using:
 
Description
 
Total
   
Quoted Prices in Active Markets for Identical Assets (Level 1)
   
Signifcant Other Observable Inputs (Level 2)
   
Significant Unobservable Inputs (Level 3)
 
Foreign currency forwards, assets
  $ 808     $ -     $ 808     $ -  
Foreign currency forwards, liabilities
    (1,486 )     -       (1,486 )     -  
Interest rate swaps
    (3,541 )     -       (3,541 )     -  
Total
  $ (4,219 )   $ -     $ (4,219 )   $ -  

13


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(9)
Fair Value Measurements (continued)

The Company’s derivative assets and liabilities include foreign exchange forward contracts and interest rate swap contracts that are measured at fair value using observable market inputs such as forward rates, interest rates, the Company’s credit risk and its counterparties’ credit risks. Based on these inputs, the derivative assets and liabilities are classified within Level 2 of the valuation hierarchy. Based on the Company’s continued ability to enter into forward contracts and interest rate swaps, the Company considers the markets for our fair value instruments to be active.

As of September 30, 2009, there has not been any significant impact to the fair value of the Company’s derivative liabilities due to its own credit risk. Similarly, there has not been any significant adverse impact to the Company’s derivative assets based on the Company’s evaluation of its counterparties’ credit risks.

(10)
Comprehensive Income/(Loss)

The following table shows the components of comprehensive income/(loss) for the three and nine months ended September 30, 2009 and 2008:

   
Three months ended
   
Nine months ended
 
   
September 30,
   
September 30,
 
   
2009
   
2008
   
2009
   
2008
 
                         
Net income
  $ 2,963     $ 2,797     $ 13,160     $ 8,879  
Foreign currency translation
    9,902       (24,022 )     13,731       (11,018 )
Unrealized gain/(loss) on hedging contracts, net of tax
    1,006       (293 )     1,826       (311 )
Pension, net of tax
    273       132       812       397  
Total
  $ 14,144     $ (21,386 )   $ 29,529     $ (2,053 )
 
 
(11)
Retirement Plans and Other Postretirement Benefits

Domestic Pension Plans

The components of net periodic pension cost for the Company’s domestic plans for the three and nine months ended September 30, 2009 and 2008 are as follows:

   
Three months ended
   
Nine months ended
 
   
September 30,
   
September 30,
 
   
2009
   
2008
   
2009
   
2008
 
                         
Components of net periodic benefit cost
                       
Interest cost
  $ 857     $ 878     $ 2,571     $ 2,634  
Expected return on plan assets
    (731 )     (1,021 )     (2,193 )     (3,063 )
Amortization of prior service costs
    109       109       327       327  
Recognized actuarial loss
    136       24       408       72  
Net periodic benefit cost
  $ 371     $ (10 )   $ 1,113     $ (30 )

14


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(11)
Retirement Plans and Other Postretirement Benefits (continued)

The Company has a Supplemental Executive Retirement Plan for key executives.  This plan is non-qualified and unfunded.  Net periodic benefit costs for the three months ended September 30, 2009 and 2008 were $84 and $77, respectively.  Net periodic benefit costs for the nine months ended September 30, 2009 and 2008 were $252 and $231, respectively.

International Pension Plan

The components of net periodic pension cost for the Company’s international plan for the three and nine months ended September 30, 2009 and 2008 are as follows:

   
Three months ended
   
Nine months ended
 
   
September 30,
   
September 30,
 
   
2009
   
2008
   
2009
   
2008
 
                         
Components of net periodic benefit cost
                       
Service cost
  $ 121     $ 137     $ 363     $ 411  
Interest cost
    170       218       510       654  
Recognized actuarial loss
    30       33       90       99  
Amortization of prior service cost
    (1 )     (2 )     (3 )     (6 )
                                 
Net periodic benefit cost
  $ 320     $ 386     $ 960     $ 1,158  

Other Postretirement Benefits

Cambrex provides certain postretirement health and life insurance benefits to all eligible retired employees.  Such plans are self-insured and are not funded.  The net periodic benefit cost for the three months ended September 30, 2009 and 2008 was $8.  The net periodic benefit cost for the nine months ended September 30, 2009 and 2008 was $24.  See Note 13 for a discussion of subsequent events related to these benefits.

(12)
Contingencies

The Company is subject to various investigations, claims and legal proceedings covering a wide range of matters that arise in the ordinary course of its business activities.  The Company continually assesses all known facts and circumstances as they pertain to all legal and environmental matters and evaluates the need for reserves and disclosures as deemed necessary based on these facts and circumstances.  These matters, either individually or in the aggregate, could have a material adverse effect on the Company's financial condition, operating results and cash flows in a future reporting period.

Environmental

In connection with laws and regulations pertaining to the protection of the environment, the Company and its subsidiaries are a party to several environmental proceedings and remediation investigations and cleanups and, along with other companies, have been named potentially responsible parties (“PRP”) for certain waste disposal sites ("Superfund sites").  Additionally, the Company has retained the liability for certain environmental proceedings associated with the sale of the Rutherford Chemicals business.

15


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(12)
Contingencies (continued)

Each of these matters is subject to various uncertainties, and it is possible that some of these matters will be decided unfavorably against the Company.  The resolution of such matters often spans several years and frequently involves regulatory oversight or adjudication.  Additionally, many remediation requirements are not fixed and are likely to be affected by future technological, site, and regulatory developments.  Consequently, the ultimate liability with respect to such matters, as well as the timing of cash disbursements cannot be determined with certainty.

In matters where the Company has been able to reasonably estimate its liability, the Company has accrued for the estimated costs associated with the study and remediation of Superfund sites not owned by the Company and the Company's current and former operating sites.  These accruals were $6,201 and $6,226 at September 30, 2009 and December 31, 2008, respectively.  The decrease in the accrual includes payments of $290 partially offset by increases to reserves of $100 and the impact of currency of $165.  Based upon available information and analysis, the Company's current accrual represents management's best estimate of the probable and estimable costs associated with environmental proceedings including amounts for investigation fees where full remediation costs may not be estimable at the reporting date.

CasChem

As a result of the sale of the Bayonne, New Jersey facility, the Company became obligated to investigate site conditions and conduct required remediation under the New Jersey Industrial Site Recovery Act.  The Company submitted a sampling plan to the New Jersey Department of Environmental Protection (“NJDEP”) and is awaiting approval.  The results of the completed and proposed sampling, and any additional sampling deemed necessary, will be used to develop an estimate of the Company's future liability for remediation costs, if any.

Cosan

In response to the NJDEP, the Company completed its initial investigation and submitted the results of the investigation and a proposed Remedial Action Work Plan (“RAW”) to the NJDEP for its Cosan Clifton, New Jersey site.  The NJDEP subsequently rejected the RAW and requested additional investigative work at the site and that work is on-going.  The reserve was $1,177 at September 30, 2009 which is based on the initial remedial action plan.  The results of the additional investigative work may impact the remediation plan and costs.

Additionally, the Company has recorded a liability of $923 for the Cosan Carlstadt, New Jersey site based on the investigations completed to date and the proposed RAW submitted to the NJDEP for their approval.  The NJDEP has subsequently required the Company to perform additional investigative work prior to approval of the RAW.  The results of this additional investigative work may impact the remediation plan and costs.
 
Berry’s Creek

The Company received a notice from the United States Environmental Protection Agency (“USEPA”) that two former operating subsidiaries of the Company are considered PRPs at the Berry’s Creek Superfund Site in New Jersey.  The operating companies are among many other PRPs that were listed in the notice.  Pursuant to the notice, the PRPs have been asked to perform a remedial investigation and feasibility study of the Berry’s Creek Site.  The Company has joined the group of PRPs and filed a response to the USEPA agreeing to jointly negotiate to conduct or fund an appropriate remedial investigation and feasibility study of the Berry’s Creek Site.  The PRPs have engaged consultants to evaluate investigation and remedial alternatives and develop a method to allocate related costs among the PRPs.  As of September 30, 2009 the Company’s reserve was $309 to cover the initial phase of investigation based on a tentative agreement on the allocation of the site investigation costs among the PRPs.  The investigation is expected to take several years and at this time it is too early to predict the extent of any additional liabilities.

16


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(12) 
Contingencies (continued)

Nepera, Inc. – Maybrook and Harriman Sites

Nepera, Inc. (“Nepera”) is named a PRP of the Maybrook Site in Hamptonburgh, New York by the USEPA in connection with the disposition, under appropriate permits, of wastewater at that site prior to Cambrex's acquisition of Nepera in 1986.  The USEPA also issued the Company a Notice of Potential Liability and the Company signed a Consent Decree to complete the Record of Decision (“ROD”) and has provided the USEPA with appropriate financial assurance, including a letter of credit to guarantee the obligation under the Consent Decree.

Nepera is also named a responsible party of the Harriman, New York production facility by the New York State Department of Environmental Conservation.  A final ROD was issued which describes the remediation plan for the site.  Implementation of the ROD is on-going.

As of September 30, 2009, the reserve recorded on the books was $1,300 and represents the Company’s best estimate to complete both RODs.

Solvent Recoveries Superfund Site

A subsidiary of the Company is one of approximately 1,300 PRPs at a Superfund site (“the Site”) in Southington, Connecticut, once operated by Solvent Recoveries, Inc.  The PRP group has completed a Remedial Investigation/Feasibility Study and the USEPA has proposed remediation of the Site.  In 2008, the Company agreed to enter into a consent decree and settlement with the other PRPs and the USEPA whereby the Company agreed to pay a settlement amount of $353 with an initial payment of $106 and the remaining $247 to be paid in installments over time as the remediation proceeds.  The Company has reserved for the unpaid portion of the settlement and has entered into a letter of credit to guarantee the payment obligation under the settlement.

Newark Bay Complex Litigation

CasChem and Cosan have been named as two of several hundred third-party defendants in a third-party complaint filed in February 2009, by Maxus Energy Corporation (“Maxus”) and Tierra Solutions, Inc. (“Tierra”).  The original plaintiffs include the NJDEP, the Commissioner of the NJDEP and the Administrator of the New Jersey Spill Compensation Fund, which originally filed suit in 2005 against Maxus, Tierra and other defendants seeking recovery of cleanup and removal costs for alleged discharges of dioxin and other hazardous substances into the Passaic River, Newark Bay, Hackensack River, Arthur Kill, Kill Van Kull and adjacent waters (the “Newark Bay Complex”).  Maxus and Tierra are now seeking contribution from third-party defendants, including subsidiaries of the Company, for cleanup and removal costs for which each may be held liable in the lawsuit. Maxus and Tierra also seek recovery for cleanup and removal costs that each has incurred or will incur relating to the Newark Bay Complex.  The Company expects to vigorously defend against the lawsuit. At this time it is too early to predict whether the Company will have any liability in this matter.

17


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(12) 
Contingencies (continued)

The Company is involved in other environmental matters where the range of liability is not reasonably estimable at this time and it is not determinable when information will become available to provide a basis for adjusting or recording an accrual, should an accrual ultimately be required.

Litigation and Other Matters

Lorazepam and Clorazepate

In 1998 the Company and a subsidiary were named as defendants (along with Mylan Laboratories, Inc. (“Mylan”) and Gyma Laboratories of America, Inc. (“Gyma”)) in a proceeding instituted by the Federal Trade Commission (“FTC”) in the United States District Court for the District of Columbia (the “District Court”).  Suits were also commenced by several State Attorneys’ General and class action complaints by private plaintiffs in various state courts.  The suits alleged violations of the Federal Trade Commission Act arising from exclusive license agreements between the Company and Mylan covering two APIs (Lorazepam and Clorazepate).  The FTC and Attorneys’ General suits were settled in February 2001.

All cases have been resolved except for one brought by four health care insurers. In 2008 the District Court, in this remaining case, entered judgment after trial against Mylan, Gyma and Cambrex in the amount of $8,355, payable jointly and severally, and also a punitive damage award against each defendant in the amount of $16,709.  In addition, the District Court ruled that the defendants were also subject to a total of approximately $7,000 in prejudgment interest.  The parties will appeal the awards.

Cambrex paid $12,415 in exchange for a release from Mylan and full indemnity in 2003 against future costs or liabilities in related litigation brought by purchasers, as well as potential future claims related to this matter.  Cambrex expects any payment of the judgment against it to be made by Mylan under the indemnity described above.

Other

The Company has commitments incident to the ordinary course of business including corporate guarantees of certain subsidiary obligations to the Company’s lenders related to financial assurance obligations under certain environmental laws for remediation; closure and third party liability requirements of certain of its subsidiaries and a former operating location; contract provisions for indemnification protecting its customers and suppliers against third party liability for manufacture and sale of Company products that fail to meet product warranties and contract provisions for indemnification protecting licensees against intellectual property infringement related to licensed Company technology or processes.

Additionally, as permitted under Delaware law, the Company indemnifies its officers, directors and employees for certain events or occurrences while the officer, director or employee is, or was, serving at the Company’s request in such capacity. The term of the indemnification period is for the officer's, director's or employee’s lifetime. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited; however, the Company has a Director and Officer insurance policy that covers a portion of any potential exposure.  The Company currently believes the estimated fair value of its indemnification agreements is not material based on currently available information, and as such, the Company has no liabilities recorded for these agreements as of September 30, 2009.

18


CAMBREX CORPORATION AND SUBSIDIARIES
Notes to Unaudited Consolidated Financial Statements (Continued)
(dollars in thousands, except share data)

(12)
Contingencies (continued)

Cambrex's subsidiaries are party to a number of other proceedings that are not considered material at this time.

(13)
Subsequent Events

The Company has evaluated subsequent events through the issuance date of this Form 10-Q.

On October 29, 2009, the Company approved the termination, effective December 31, 2009, of certain post-retirement health and life insurance benefits previously provided to eligible retired employees.  The Company expects this decision will result in an increase to pre-tax income in the fourth quarter 2009 of approximately $1,500.
 
In October 2009, the Company was named in a lawsuit by the former owners of a business acquired in 2006 by the Company’s subsidiary.  The subsidiary was subsequently sold with the Bioproducts and Biopharma segments in 2007. The lawsuit alleges the Company and its codefendants failed to pay certain accelerated milestone payments that the Company estimates to be $4,800. The Company believes that it is entitled to indemnification from the purchasers of the Bioproducts and Biopharma segments for any potential costs, expenses and damages related to this lawsuit and therefore, has no reserve recorded as of September 30, 2009. Further, Cambrex believes that the complaint lacks merit and should it be necessary, the Company intends to vigorously defend against the lawsuit.

19


CAMBREX CORPORATION AND SUBSIDIARIES
(dollars in thousands, except share data)

Item 2. 
Management's Discussion and Analysis of Financial Condition and Results of Operations

Executive Overview

The following significant events occurred during the third quarter 2009:
 
 
·
Sales increased 2.3% on a reported basis compared to third quarter 2008.  Sales, excluding currency impact, increased 6.1%, or $3,459.
 
·
Gross margins increased on a reported basis to 29.3% from 28.7% in the third quarter 2008. Gross margin, excluding currency impact, increased to 32.0% in the third quarter 2009.
 
·
Operating profit improved to $5,627 from $4,542 in the third quarter 2008.
 
·
Debt, net of cash was $78,713 at the end of the third quarter 2009, a $4,330 improvement during the current quarter.

Results of Operations

Comparison of Third Quarter 2009 versus Third Quarter 2008

Gross sales in the third quarter 2009 of $57,802 were $1,294 or 2.3% above the third quarter 2008.  Excluding a 3.8% unfavorable impact of foreign exchange, reflecting a stronger U.S. dollar, sales increased 6.1%.  The increase is primarily due to higher volumes of an active pharmaceutical ingredient (“API”) used in the Company’s polymeric drug delivery technology, increased generic revenues resulting from the timing of orders and higher controlled substances and custom development revenues.  Partially offsetting these increases were lower sales of two APIs manufactured under long-term supply agreements and a feed additive for which a contract was terminated earlier in 2009.

The following table reflects sales by geographic area for the three months ended September 30, 2009 and 2008:

   
Three months ended September 30,
 
   
2009
   
2008
 
             
North America
  $ 22,586     $ 19,465  
Europe
    30,765       33,029  
Asia
    2,592       1,041  
Other
    1,859       2,973  
Total gross sales
  $ 57,802     $ 56,508  

Gross margins increased to 29.3% in the third quarter 2009 from 28.7% in the third quarter 2008.  Cost reductions and favorable product mix were the main drivers of the higher margins.  This was partially offset by lower pricing of generic APIs and an API manufactured under a long-term supply agreement.  Gross margins were unfavorably impacted 2.7% due to foreign currency exchange.

Selling, general and administrative expenses of $9,295 or 16.1% of gross sales in the third quarter 2009 increased from $8,767, or 15.5% in the third quarter 2008. The increase is a result of higher legal fees and personnel costs partially offset by a favorable impact of foreign currency.

20


Results of Operations (continued)
 
Comparison of Third Quarter 2009 versus Third Quarter 2008 (continued)

Research and development (“R&D”) expenses of $2,026 were 3.5% of gross sales in the third quarter 2009, compared to $1,772 or 3.1% of gross sales in the third quarter 2008.  The increase is primarily due to higher costs related to the development of new products and technology platforms.

Restructuring expenses for the third quarter 2008 were $321, the majority of which consists of rent and related costs associated with the closure of the New Jersey R&D facility.

Strategic alternative costs for the third quarter 2008 were $833, primarily consisting of costs associated with a project to streamline the Company’s legal structure.

Operating profit in the third quarter 2009 was $5,627 compared to $4,542 in the third quarter 2008.  Excluding restructuring expenses and strategic alternative costs of $1,154 recorded in 2008, operating profit was flat quarter over quarter.  An unfavorable impact of foreign currency and higher administrative spending mostly offset higher gross margins as discussed above.

Net interest expense was $1,111 in the third quarter 2009 compared to $956 in the third quarter 2008.  Third quarter 2009 results reflect lower interest income in the third quarter 2009 compared to the same period last year as a result of lower interest rates.  Higher average debt was mostly offset by lower interest rates during the quarter.  The average interest rate on debt was 3.6% in the third quarter 2009 versus 4.7% in the third quarter 2008.

The effective tax rate for the third quarter 2009 was 34.8% compared to 9.8% in the third quarter 2008. The tax provision in the third quarter 2009 was $1,584 compared to $304 in the third quarter 2008.  The increase is due to changes in the geographic mix of pre-tax earnings, the enactment of reduced tax rates in Sweden and tax benefits related to the favorable resolution of certain tax matters in the three months ended September 30, 2008.  The Company maintains a full valuation allowance against its domestic, and certain foreign, net deferred tax assets and will continue to do so until an appropriate level of profitability is sustained or tax strategies can be developed that would enable the Company to conclude that it is more likely than not that a portion of these net deferred tax assets would be realized.  As such, improvements in pre-tax income in the future within these jurisdictions where the Company maintains a valuation allowance may result in these tax benefits ultimately being realized.  However, there is no assurance that such improvements will be achieved.

Net income in the third quarter 2009 was $2,963, or $0.10 per diluted share, versus $2,797, or $0.10, per diluted share in the same period a year ago.

Comparison of First Nine Months 2009 versus First Nine Months 2008

Gross sales for the first nine months of 2009 of $177,568 were $6,872 or 3.7% below the first nine months of 2008.  Excluding an 8.3% unfavorable impact of foreign exchange, reflecting a stronger U.S. dollar in the first nine months of 2009 versus 2008, sales were 4.6% higher than the same period last year.  The increase is primarily due to higher volumes of an API used in the Company’s polymeric drug delivery technology, higher controlled substances, an API manufactured under a long-term supply agreement and custom development revenues.  Partially offsetting these increases were lower sales of generic APIs and a feed additive for which a contract was terminated earlier in 2009.

21


Results of Operations (continued)
 
Comparison of First Nine Months 2009 versus First Nine Months 2008 (continued)

The following table reflects sales by geographic area for the nine months ended September 30, 2009 and 2008:

   
Nine months ending September 30,
 
   
2009
   
2008
 
             
North America
  $ 61,040     $ 65,200  
Europe
    103,256       104,911  
Asia
    7,382       8,228  
Other
    5,890       6,101  
Total gross sales
  $ 177,568     $ 184,440  
 
Gross margins were flat at 31.4% in the first nine months of 2009 compared to the first nine months of 2008.  Gross margins were favorably impacted 2.5% due to foreign currency exchange.  Excluding the foreign currency impact, the decrease in margins is mainly due to lower pricing related to our generics products and an API manufactured under a long-term supply agreement.

Selling, general and administrative expenses of $26,889 or 15.1% of gross sales in the first nine months of 2009 decreased from $31,511 or 17.1% in the first nine months of 2008.  The decrease in expense is due primarily to lower spending at the operating sites and the impact of foreign currency exchange partially offset by higher legal fees.

R&D expenses were $5,924 or 3.3% of gross sales in the first nine months of 2009 compared to $5,945 or 3.2% of gross sales in the first nine months of 2008.  The results reflect the increased utilization of certain R&D personnel on revenue-generating custom development projects resulting in these costs being classified as either inventory or cost of goods offset by higher costs related to the development of new products and technology platforms.

Restructuring expenses for the first nine months of 2008 were $1,469, consisting of rent and related costs associated with the closure of the New Jersey R&D facility and costs associated with the restructuring of the corporate office.

Strategic alternative costs for the first nine months of 2008 were $1,408, consisting of costs associated with a project to streamline the Company’s legal structure, change-in-control benefits and costs associated with the modification of employee stock options due to the payment of the special dividend in connection with the 2007 divestiture of the businesses that comprised the Bioproducts and Biopharma segments.

Operating profit in the first nine months of 2009 was $22,951 compared to $17,642 in the first nine months of 2008.  The results reflect lower administrative expenses at the operating sites, lower strategic alternative and restructuring costs and the favorable impact of foreign currency partially offset by lower gross profit.

Net interest expense was $3,410 in the first nine months of 2009 compared to $2,302 in the first nine months of 2008.  The first nine months of 2009 results reflect higher average debt partially offset by lower interest rates compared to the first nine months of 2008, lower interest income and lower capitalized interest.

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Results of Operations (continued)
 
Comparison of First Nine Months 2009 versus First Nine Months 2008 (continued)

The average interest rate on debt was 3.9% in the first nine months of 2009 versus 4.9% in the first nine months of 2008.

The effective tax rate for the first nine months of 2009 was 33.1% compared to 40.3% in the first nine months of 2008.  The tax provision in the first nine months of 2009 was $6,520 compared to $6,002 in the first nine months of 2008.  The increase is due to changes in the geographic mix of pre-tax earnings, the enactment of reduced tax rates in Sweden and tax benefits related to the favorable resolution of certain tax matters in the nine months ended September 30, 2008.  The Company maintains a full valuation allowance against its domestic, and certain foreign, net deferred tax assets and will continue to do so until an appropriate level of profitability is sustained or tax strategies can be developed that would enable the Company to conclude that it is more likely than not that a portion of these net deferred tax assets would be realized.  As such, improvements in pre-tax income in the future within these jurisdictions where the Company maintains a valuation allowance may result in these tax benefits ultimately being realized.  However, there is no assurance that such improvements will be achieved.

In July 2009, the Company’s Italian subsidiary received a preliminary report from the local taxing authority related to an audit of the subsidiary’s 2006 tax return.  This report challenged the deductibility of certain intercompany transactions for 2006 and the benefits related to a transaction initiated in 2003.  In October 2009, the Company formally responded to the preliminary report. The Company expects the tax authority to either respond in the Company’s favor, or issue a formal assessment prior to December 31, 2009 based upon the merits of the Company’s response.  If the tax authority were to disagree with the Company’s position on these issues, the Company estimates an assessment, excluding penalties, could be levied against this subsidiary for up to $7,000 based upon the preliminary report.  Although it is early in the process at this time, the Company has analyzed these issues in accordance with guidance on uncertain tax positions and believes its reserves are adequate, and intends to defend itself.

In September 2009, the Company’s Swedish subsidiary was examined by the local taxing authority. The tax authority has questioned certain significant intercompany balances and transactions.  The Company expects to file a response to the inquiry in November 2009.  The Company expects it to take several months before a formal audit report is issued.  If the tax authority were to disagree with the Company’s position on these issues, the Company estimates the preliminary assessment would be less than $2,000.  Although it is early in the process at this time, the Company has analyzed these issues in accordance with guidance on uncertain tax positions and believes its reserves are adequate, and intends to defend itself.

Net income for the first nine months of 2009 was $13,160, or $0.45 per diluted share, versus $8,879, or $0.31 per diluted share, in the same period a year ago.

Liquidity and Capital Resources

Cash and cash equivalents increased $12,805 in the first nine months of 2009.   During the first nine months of 2009, cash provided by operations was $19,556 versus cash used in operations of $2,902 in the same period a year ago.  The increase in cash flows from operations in the first nine months of 2009 versus the first nine months of 2008 is due primarily to the unusually large cash payments required in 2008 related to change-in-control and restructuring payments, and better year to date inventory management during 2009.
 
Cash flows in the first nine months of 2009 related to capital expenditures were $9,651 compared to $22,908 in 2008.  The majority of the funds in 2009 were used for a new mid-scale Pharma manufacturing facility in Karlskoga, Sweden and capital improvements to existing facilities.  The majority of the funds in 2008 were used for the new facility in Karlskoga, Sweden, an API purification facility in Milan, Italy and capital improvements to existing facilities.

23


Results of Operations (continued)
 
Liquidity and Capital Resources (continued)

Cash flows provided by financing activities in the first nine months of 2009 was $156 compared to $19,428 in the same period a year ago.  Cash inflows in 2009 and 2008 related to net borrowings used for domestic operations, capital expenditures and payments related to certain accruals.

Many of Cambrex’s contracts are short-term in duration.  As a result, the Company must continually replace its contracts with new contracts to sustain its revenue.  In addition, certain of the Company’s long-term contracts may be cancelled or delayed by clients for any reason upon notice.  The Company currently has a long-term sales contract that accounts for approximately 10% of annual sales that is scheduled to expire at the end of 2013.  There is no guarantee that this contract will be renewed.  The Company also has a contract for certain drug delivery products that accounted for nearly 4% of annual sales in 2008 that expired in September 2009.  The Company has tentatively agreed on certain commercial terms for a new multi-year agreement and believes a final agreement will be signed.  However, should a new commercial agreement not be signed, it is likely that the parties will pursue certain legal actions to enforce their respective rights, specifically, the customer has filed an opposition to the Company’s patent in the European Union related to the products sold under this contract and is also seeking a patent for a competing product in certain jurisdictions including the European Union. The Company believes it has enforceable intellectual property rights and should a new agreement not be signed it intends to enforce these rights as necessary. While the outcome of these actions is uncertain, should the customer’s opposition or patent application be successful, it would unfavorably impact the Company’s sales volumes and pricing compared to the previous contract.

The Company believes that cash flows from operations along with funds available from a revolving line of credit will be adequate to meet the operational and debt servicing needs of the Company, but no assurances can be given that this will continue to be the case, especially in light of the recent unprecedented volatility in worldwide credit markets.  The Company was in compliance with all financial covenants at September 30, 2009.

Impact of Recent Accounting Pronouncements

Fair Value Measurements

The Company adopted the Financial Accounting Standards Board (“FASB”) Statement “Fair Value Measurements” related to nonfinancial assets and nonfinancial liabilities effective January 1, 2009.  This statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles (“GAAP”), and expands disclosures about fair value measurements.  This statement applies whenever another standard requires (or permits) assets or liabilities to be measured at fair value.   The standard does not expand the use of fair value to any new circumstances.  The effect of adopting this pronouncement did not have a material impact on the Company’s financial position or results of operations.

Disclosures about Derivative Instruments and Hedging Activities
 
The Company adopted the FASB’s Statement “Disclosures about Derivative Instruments and Hedging Activities” effective January 1, 2009.  This statement requires enhanced disclosures about derivative and hedging activities and thereby improves the transparency of financial reporting.  This statement also encourages, but does not require, comparative disclosures for earlier periods at initial adoption.  The effect of adopting this pronouncement did not have an impact on the Company’s financial position or results of operations.

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Employers’ Disclosures about Postretirement Benefit Plan Assets

In December 2008, the FASB issued “Employers’ Disclosures about Postretirement Benefit Plan Assets.”  This statement provides guidance on additional disclosures about plan assets of a defined benefit pension or other postretirement plan.  This statement is effective for fiscal years ending after December 15, 2009.  Upon initial application, the provisions of this pronouncement are not required for earlier periods that are presented for comparative purposes. The Company is currently evaluating the disclosure requirements of this new statement.

Subsequent Events

The Company adopted the FASB’s Statement “Subsequent Events” effective June 30, 2009.  This statement establishes general standards of accounting for, and disclosure of, events that occur after the balance sheet date but before financial statements are issued or are available to be issued.  This statement requires the disclosure of the date through which an entity has evaluated subsequent events and the basis for that date, that is, whether that date represents the date the financial statements were issued or were available to be issued.  The effect of adopting this pronouncement did not have a material impact on the Company’s financial position or results of operations.

FASB Accounting Standards Codification and the Hierarchy of GAAP

The Company adopted the FASB’s Statement “The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles” effective September 30, 2009.  This statement provides for the FASB Accounting Standards Codification to become the single official source of authoritative, nongovernmental U.S. GAAP.  This statement does not change GAAP but reorganizes the literature.

Measuring Liabilities at Fair Value

In August 2009, the FASB issued “Fair Value Measurements and Disclosures —Measuring Liabilities at Fair Value.”  This update provides amendments to “Fair Value Measurements and Disclosures – Overall”, for the fair value measurement of liabilities.  This update provides clarification for circumstances in which a quoted price in an active market for the identical liability is not available, how to estimate the fair value of a liability and how to determine the quoted price.  The amendments in this update reduce potential ambiguity in financial reporting when measuring the fair value of liabilities.  This update is effective for the first reporting period beginning after issuance.  The Company is currently evaluating the potential impact of this update.

Revenue Arrangements with Multiple Deliverables

In September 2009, the Emerging Issues Task Force (“EITF”) issued “Revenue Arrangements with Multiple Deliverables.” This issue addresses how to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting, and how to allocate the consideration to each unit of accounting.  This issue will supersede EITF 00-21 “Revenue Arrangements with Multiple Deliverables.”  This issue eliminates the use of the residual value method for determining allocation of arrangement consideration; and allows the use of an entity's best estimate to determine the selling price if vendor specific objective evidence and third-party evidence can not be determined.  This issue also requires additional disclosure to provide both qualitative and quantitative information regarding the significant judgments made in applying this issue.  In addition, for each reporting period in the initial year of adoption, this issue requires disclosure of the amount of revenue recognized subject to the measurement requirements of this issue and the amount of revenue that would have been recognized if the related transactions were subject to the measurement requirements of Issue 00-21.  This issue is effective for revenue arrangements entered into or materially modified in fiscal years beginning after June 15, 2010.  Early adoption is permitted.  The Company is currently evaluating the potential impact of this issue.

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Forward-Looking Statements

This document may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and Rule 3b-6 under The Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding expected performance, especially expectations with respect to sales, research and development expenditures, earnings per share, capital expenditures, acquisitions, divestitures, collaborations, or other expansion opportunities.  These statements may be identified by the fact that they use words such as “expects,” “anticipates,” “intends,” “estimates,” “believes” or similar expressions in connection with any discussion of future financial and operating performance.  Any forward-looking statements are qualified in their entirety by reference to the factors discussed throughout this Form 10-Q.  Any forward-looking statements contained herein are based on current plans and expectations and involve risks and uncertainties that could cause actual outcomes and results to differ materially from current expectations including, but not limited to, global economic trends, pharmaceutical outsourcing trends, competitive pricing or product developments, government legislation and regulations (particularly environmental issues), tax rate, interest rate, technology, manufacturing and legal issues, including the outcome of outstanding litigation disclosed in the Company’s public filings, the Company’s ability to satisfy the continued listing standards of the New York Stock Exchange, changes in foreign exchange rates,  uncollectible receivables, loss on disposition of assets, cancellation or delays in renewal of contracts, lack of suitable raw materials or packaging materials, the Company’s ability to receive regulatory approvals for its products and other factors described in Item 1A “Risk Factors” within this Form 10-Q.  Any forward-looking statement speaks only as of the date on which it is made, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.  New factors emerge from time to time and it is not possible for the Company to predict which will arise.  In addition, the Company cannot assess the impact of each factor on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

For further details and a discussion of these and other risks and uncertainties, investors are cautioned to review the Cambrex 2008 Annual Report on Form 10-K, including the Forward-Looking Statement section therein, and other filings with the U.S. Securities and Exchange Commission.  The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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Quantitative and Qualitative Disclosures about Market Risk

There has been no significant change in the Company’s exposure to market risk during the first nine months of 2009.  For a discussion of the Company’s exposure to market risk, refer to Part II, Item 7A, “Quantitative and Qualitative Disclosures about Market Risk,” contained in the Company’s Annual Report on Form 10-K for the period ended December 31, 2008.
 
Item 4.
Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Form 10-Q.  Based on that evaluation, our chief executive officer and chief financial officer have concluded that, as of the end of such period, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to management, including our chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure.
 
Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II - OTHER INFORMATION

CAMBREX CORPORATION AND SUBSIDIARIES

Legal Proceedings

See the discussion under Part I, Item 1, Note 12 to the Consolidated Financial Statements.

Risk Factors

Factors That May Affect Future Results

The following risk factors and other information included in this Quarterly Report on Form 10-Q should be carefully considered.  If any of the following risks occur, the Company’s business, financial condition, operating results and cash flows could be materially adversely affected.  The risks and uncertainties described below are not the only ones the Company faces.  Additionally, risks and uncertainties not presently known to the Company or that it currently deems immaterial also may impair its business, financial condition, operating results and cash flows in the future.

Risks Relating to Cambrex’s Business
 
 
Companies may discontinue or decrease their usage of Cambrex’s services.

The Company has observed increasing pressure on the part of its customers to reduce spending, including the use of its services and products, as a result of negative macro-economic trends and various market dynamics specifically affecting the pharmaceutical industry.  These customers could discontinue or decrease their usage of Cambrex’s services and products, including as a result of the global economic slowdown.
 
 
New technologies, competition or a reduction in demand for Cambrex’s products could reduce sales.

The markets for the Company’s products are competitive and price sensitive.  The Company’s competitors may lower prices on products in the future and the Company may, in certain cases, respond by lowering its prices.  Conversely, failure to anticipate and respond to price competition may hurt Cambrex’s market share. Some of the Company’s competitors also have significant financial, operational, sales and marketing resources, and experience in research and development (“R&D”) which may reduce the Company’s level of business.  Companies may develop new technologies that would compete with the Company’s products or render its products obsolete.  Several of Cambrex’s customers, especially those that buy its generic active pharmaceutical ingredients, have internal capabilities similar to Cambrex’s.  In addition, demand for the Company’s products may weaken due to a reduction in R&D budgets, loss of distributors or other factors.

The Company believes that customers in its markets display loyalty to their initial supplier of a particular product.  Therefore, it may be difficult to generate sales to potential customers who have purchased products from competitors.  To the extent the Company is unable to be the first to develop and supply new products, its competitive position may suffer.

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The Company’s failure to obtain new contracts or renew existing contracts may adversely affect its business.

Many of Cambrex’s contracts are short-term in duration.  As a result, the Company must continually replace its contracts with new contracts to sustain its revenue.  In addition, certain of the Company’s long-term contracts may be cancelled or delayed by clients for any reason upon notice.  The Company currently has a long-term sales contract that accounts for approximately 10% of annual sales that is scheduled to expire at the end of 2013.  There is no guarantee that this contract will be renewed.  The Company also has a contract for certain drug delivery products that accounted for nearly 4% of annual sales in 2008 that expired in September 2009.  The Company has tentatively agreed on certain commercial terms for a new multi-year agreement and believes a final agreement will be signed.  However, should a new commercial agreement not be signed, it is likely that the parties will pursue certain legal actions to enforce their respective rights, specifically, the customer has filed an opposition to the Company’s patent in the European Union related to the products sold under this contract and is also seeking a patent for a competing product in certain jurisdictions including the European Union. The Company believes it has enforceable intellectual property rights and should a new agreement not be signed it intends to enforce these rights as necessary. While the outcome of these actions is uncertain, should the customer’s opposition or patent application be successful, it would unfavorably impact the Company’s sales volumes and pricing compared to the previous contract.

Failure to obtain products and raw materials from third-party manufacturers could affect Cambrex’s ability to manufacture and deliver its products.

The Company relies on third-party manufacturers to supply many of its raw materials and intermediates.  In addition, the Company has a single source for supplies of some raw materials to its products.  Manufacturing problems may occur with these and other outside sources.  If such problems occur, the Company cannot ensure that it will be able to manufacture its products profitably or on time.

Disruptions to the Company’s manufacturing operations could adversely affect its results.

Due to heavy reliance on manufacturing and related operations to produce and distribute the products the Company sells, the Company could be adversely affected by disruptions of these operations.  Any significant disruption of those operations for any reason, such as labor unrest, power interruptions, fire, or other events beyond the Company’s control could adversely affect its sales and customer relationships and therefore adversely affect its business. While insurance coverage may reimburse the Company, in part, for profits lost from such disruptions, any sustained reduction in the Company’s ability to provide these products would negatively impact its sales growth expectations, cash flows and profitability.

Failure to win early stage business opportunities can cause difficulty in winning future opportunities with that customer.

Certain products the Company sells are incorporated into its customers’ drug manufacturing processes. In some cases, once a customer chooses a particular product for use in a drug manufacturing process, it is unlikely that the customer will later switch to a competing alternative. In many cases, the regulatory approvals related to a drug product will specify the products qualified for use in its making. Obtaining the regulatory approvals needed for a change in the manufacturing process is time consuming, expensive and uncertain. Accordingly, if a customer does not select the Company’s products or services early in its manufacturing design phase for any number of reasons, the Company may lose the opportunity to participate in the customer’s manufacturing of such product. Because the Company faces competition in this market from other companies, it is at risk that its competitors could win significant early business with customers making it difficult for the Company to recover late-stage opportunities with higher volumes.

Litigation may harm the Company or otherwise negatively impact its management and financial resources.

Complex or extended litigation could cause the Company to incur large expenditures and distract its management.  For example, lawsuits by employees, stockholders, counterparties to acquisition and divestiture contracts, collaborators, distributors, customers, or end-users of the Company’s products or services could be very costly and substantially disrupt its business.  Disputes from time to time with such companies or individuals are not uncommon, and the Company cannot be assured that it will always be able to resolve such disputes out of court or on terms favorable to the Company.

Refer to Note 12 for a discussion of the Company’s environmental and legal matters.

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Incidents related to hazardous materials could adversely affect the Company.

Portions of the Company’s operations require the controlled use of hazardous materials.  Although the Company is diligent in designing and implementing safety procedures to comply with the standards prescribed by federal, state, local and foreign regulations, including the European Commission’s Registration, Evaluation and Authorization of Chemicals (“REACH”) regulation, the risk of accidental contamination of property or injury to individuals from these materials cannot be completely eliminated.  In the event of such an incident, the Company could be liable for any damages which could adversely affect its business.  Additionally, any incident could shut down the Company’s research and manufacturing facilities and operations.

The Company generates waste that must be transported to approved storage, treatment and disposal facilities.  The transportation and disposal of such waste are required to meet applicable state and federal statutes and regulations.  The storage, treatment and disposal of such waste potentially exposes the Company to environmental liability if, in the future, such transportation and disposal are deemed to have violated such statues or regulations or if the storage, treatment and disposal facilities are inadequate and are proved to have damaged the environment.

The Company is also party to several environmental remediation investigations and cleanups and, along with other companies, has been named a potentially responsible party for certain waste disposal sites.

Refer to Note 12 for a discussion of the Company’s environmental and legal matters.

Potential product liability claims, errors and omissions claims in connection with services the Company performs and potential liability under indemnification agreements between the Company and its officers and directors could adversely affect the Company.

The Company manufactures products intended for use by the public.  These activities could expose the Company to risk of liability for personal injury or death to persons using such products, even though the Company does not presently market or sell the products to end users.  The Company seeks to reduce its potential liability through measures such as contractual indemnification provisions with clients (the scope of which may vary from client-to-client, and the performances of which are not secured), exclusion of services requiring diagnostic or other medical services, and insurance maintained by clients.  The Company could be materially and adversely affected if it were required to pay damages or incur defense costs in connection with a claim that is outside the scope of the indemnification agreements, if the indemnity, although applicable, is not performed in accordance with its terms or if the Company’s liability exceeds the amount of applicable insurance or indemnity.  In addition, the Company could be held liable for errors and omissions in connection with the services it performs.  The Company currently maintains product liability and errors and omissions insurance with respect to these risks.  There can be no assurance, however, that the Company’s insurance coverage will be adequate or that insurance coverage will continue to be available on terms acceptable to the Company.

The Company also indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity.  The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited; however, the Company has a Director and Officer insurance policy that covers a portion of any potential exposure.  The Company could be materially and adversely affected if it were required to pay damages or incur legal costs in connection with a claim above its insurance limits.

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While the Company has what it believes to be adequate insurance coverage, any claims beyond its insurance coverage may result in substantial costs and a reduction in its available capital resources.

The Company maintains property insurance policies covering physical damage to its equipment, facilities, buildings and inventory; employer’s liability insurance generally covering death or work injury of employees; product liability insurance covering product liability claims arising from the use, consumption or operation of its products; public liability insurance covering certain incidents to third parties that occur on or in the premises of the company; business interruption insurance and directors and officers liability insurance, among others.  The Company does not maintain key man life insurance on any of its senior management or key personnel.  The Company’s insurance coverage, however, may not be sufficient to cover any claim for product liability, damage to its fixed assets or injury to its employees.

Loss of key personnel could hurt the Company.

The Company depends on its ability to attract and retain qualified scientific and technical employees as well as a number of key executives.  There can be no assurance the Company will be able to retain key personnel, or to attract and retain additional qualified employees.  The Company’s inability to attract and retain key personnel would have a material adverse effect on the Company’s business.

The Company has made significant capital investments to its facilities to meet its potential future needs and, as a result, the Company depends on the success of attracting new and retaining existing customers’ projects and their continued business.

The Company has recently made substantial investments in all of its manufacturing facilities.  With the completion of these new facilities, the Company’s fixed costs have increased.  If the Company is not able to utilize the facilities to capacity, its margins could be adversely affected.

Global growth is subject to a number of economic risks.

The current global economy affects businesses such as Cambrex’s in a number of ways.  The current equity market and tightening of credit in financial markets adversely affects the ability of the Company’s customers to obtain financing for significant purchases and operations and could result in a decrease in or cancellation of orders for its products and services as well as impact the ability of the Company’s customers to make payments. The Company believes that cash flows from operations, along with funds available from a revolving line of credit, will be adequate to meet the operational and debt servicing needs of the Company, but no assurances can be given that this will continue to be the case.  Given the current state of the worldwide credit markets, there is a risk that the funds available to be drawn under the Company’s revolving line of credit may not be available in the event of the failure of one or more participant banks.  Strengthening of the rate of exchange for the U.S. dollar against certain major currencies such as the Euro, Swedish krona and other currencies also adversely affects the Company’s results.

The Company has a significant amount of debt.

The Company has a $200,000 revolving credit facility of which $124,000 was outstanding at September 30, 2009.  This facility expires in April of 2012.  If the Company is unable to generate sufficient cash flow or otherwise obtain funds necessary to make required payments on the credit facility, it will be in default.  This current debt arrangement requires the Company to comply with specified financial ratios. The Company’s ability to comply with these ratios may be affected by events beyond its control.

Even if the Company is able to meet its debt service obligations, the amount of debt it has could adversely affect the Company by limiting its ability to obtain any necessary financing in the future for working capital, capital expenditures, debt service requirements, or other purposes.  It also places the Company at a disadvantage relative to its competitors who have lower levels of debt, while making it more vulnerable to a downturn in its business or the economy in general.  It also requires the Company to use a substantial portion of its cash to pay principal and interest on its debt, instead of investing those funds in the business.

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The Company’s liquidity, business, financial condition, results of operations and cash flows could be materially and adversely affected if the financial institutions which hold its funds fail.

The Company has significant funds held in bank deposits, money market funds and other accounts at certain financial institutions.  A significant portion of the funds held in these accounts exceed insurable limits.  If any of the financial institutions where the Company has deposited funds were to fail, the Company may lose some or all of its deposited funds that exceed the insurance coverage limit. Such a loss would have a material and adverse effect on the Company’s liquidity, business, financial condition, results of operations and cash flows.

A payment failure by any large customer or multiple smaller customers could adversely affect the Company’s cash flows and profitability.

Historically, the Company has not experienced any significant bad debt or collection problems, but such problems may arise in the future. The failure of any of the Company’s customers to make timely payments could require the Company to write off accounts receivable or increase provisions made against its accounts receivable, either of which could adversely affect the Company’s cash flows and profitability.

The Company has significant inventories on hand.

The Company maintains significant inventories and has an allowance for slow-moving and obsolete inventory. Any significant unanticipated changes in future product demand or market conditions, including the current uncertainty in the global market, could also have an impact on the value of inventory and adversely impact the Company’s results of operations.

International unrest or foreign currency fluctuations could adversely affect the Company’s results.

The Company’s international revenues, which include revenues from its non-U.S. subsidiaries and export sales from the U.S., represent the majority of its product revenues.

There are a number of risks arising from the Company’s international business, including:

 
·
the possibility that unfriendly nations or groups could boycott its products;
 
 
·
general economic and political conditions in the markets in which it operates;
 
 
·
potential increased costs associated with overlapping tax structures;
 
 
·
more limited protection for intellectual property rights in some countries;
 
 
·
unexpected changes in regulatory requirements;
 
 
·
the difficulties of compliance with a wide variety of foreign laws and regulations;
 
 
·
longer accounts receivable cycles in certain foreign countries; and
 
 
·
import and export licensing requirements.

In addition, a significant portion of the Company’s business is conducted in currencies other than the U.S. dollar, which is its reporting currency.  The Company recognizes foreign currency gains or losses arising from its operations in the period incurred.  As a result, currency fluctuations between the U.S. dollar and the currencies in which the Company does business have caused, and will continue to cause, foreign currency transaction gains and losses.  The Company cannot predict the effects of exchange rate fluctuations upon its future operating results because of the number of currencies involved, the variability of currency exposures, and the potential volatility of currency exchange rates.  The Company engages in limited foreign exchange hedging transactions to mitigate the impact of this volatility on its operations, but its strategies are short-term in nature and may not adequately protect its operating results from the full effects of exchange rate fluctuations.

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Cambrex’s operating results may unexpectedly fluctuate in future periods.

The Company’s revenue and operating results have fluctuated, and could continue to fluctuate, on a quarterly basis.  The operating results for a particular quarter may be lower than expected as a result of a number of factors, including, but not limited to, the timing of contracts; the delay or cancellation of a contract; the mix of services provided; seasonal slowdowns in different parts of the world; the timing of start-up expenses for new services and facilities; changes in government regulations; and unfavorable exchange rates with the U.S. dollar.  Because a high percentage of the Company’s costs are relatively fixed in the short term, such as the cost of maintaining facilities and compensating employees, any one of these factors could have a significant impact on the Company’s quarterly results.  In some quarters, the Company’s revenue and operating results may fall below the expectations of securities analysts and investors due to any of the factors described above.  If such event occurred, sales of common stock by existing holders would cause the trading price of the Company’s common stock to decline, even if the decline in revenue did not have any long-term adverse implications for the Company’s business.

The possibility the Company will be unable to protect its technologies could affect its ability to compete.

The Company’s success depends to a significant degree upon its ability to develop proprietary products and technologies.  However, the Company cannot be assured that patents will be granted on any of its patent applications.  The Company also cannot be assured that the scope of any of its issued patents will be sufficiently broad to offer meaningful protection.  The Company has patents issued in selected countries, therefore, third parties can make, use, and sell products covered by its patents in any country in which the Company does not have patent protection.  In addition, issued patents or patents the Company licenses could be successfully challenged, invalidated or circumvented so that its patent rights would not create an effective competitive barrier.  The Company provides its customers the right to use its products under label licenses that are for research purposes only.  These licenses could be contested, and the Company cannot be assured that it would either be aware of an unauthorized use or be able to enforce the restrictions in a cost-effective manner.

If a third party claimed an intellectual property right to technology the Company uses, it may need to discontinue an important product or product line, alter its products and processes, defend its right to use such technology in court or pay license fees.  Although the Company may, under these circumstances, attempt to obtain a license to such intellectual property, it may not be able to do so on favorable terms, or at all.  Additionally, if Cambrex’s products are found to infringe on a third party’s intellectual property, the Company may be required to pay damages for past infringement, and lose the ability to sell certain products or receive licensing revenues.

The Company could be subject to goodwill impairment charges in the future.

Under U.S. GAAP, the Company is required to evaluate goodwill for impairment at least annually.  If the Company determines that the fair value is less than the carrying value, an impairment loss will be recorded in the Company’s statement of operations.  The determination of fair value is a highly subjective exercise and can produce significantly different results based on the assumptions used and methodologies employed.  If the Company’s projected long-term sales growth rate, profit margins or terminal rate are considerably lower and/or the assumed weighted average cost of capital is considerably higher, future testing may indicate impairment and the Company would have to record a non-cash goodwill impairment loss in its statement of operations.

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Assessments by various tax authorities may be materially different than the Company has provided for and it may experience significant volatility in its annual and quarterly effective tax rate.

As a matter of course, the Company is regularly audited by federal, state, and foreign tax authorities.  From time to time, these audits result in proposed assessments.  In recent years, the Company utilized significant tax attributes in the form of foreign tax credits and U.S. net operating loss carryforwards to reduce or eliminate potential tax expense related to the repatriation of funds into the U.S. resulting from the 2005 Jobs Creation Act and from the sale of the businesses that comprised the Bioproducts and Biopharma segments in 2007.  While the Company believes that it has adequately provided for any taxes related to these items, and taxes related to all other aspects of its business, any such assessments or future settlements may be materially different than it has provided.

The Company may pursue transactions that may cause it to experience significant charges to earnings that may adversely affect its stock price and financial condition.

The Company regularly reviews potential transactions related to technologies, products, product rights and businesses complementary to its business.  These transactions could include mergers, acquisitions, divestitures, strategic alliances or licensing agreements.  In the future, the Company may choose to enter into these transactions at any time.  As a result of acquiring businesses or entering into other significant transactions, the Company may experience significant charges to earnings for merger and related expenses.  If the Company is not able to successfully integrate the acquired business to create the advantages the acquisition was intended to create, it may affect the Company’s results of operations and the market price of its common stock.  Furthermore, if the Company is unable to improve the operating margins of acquired businesses or operate them profitably, it may be unable to achieve its growth strategy.

Risks Related to Cambrex’s Industry

Any significant change in government regulation of the drug development process could have a material adverse effect on the Company.

The manufacturing of pharmaceutical products is subject to extensive regulation by governmental authorities, including the Food and Drug Administration (“FDA”) and comparable regulatory authorities in other countries.  The Company’s business, as well as its customer’s business depends in part on strict government regulation of the drug development process.  Legislation may be introduced and enacted from time to time to modify regulations administered by the FDA and governing the drug approval process.  Any significant reduction in the scope of regulatory requirements or the introduction of simplified drug approval procedures could have a material adverse effect on the Company’s business.

Violations of cGMP and other government regulations could have a material adverse effect on the Company.

All facilities and manufacturing techniques used for manufacturing products for clinical use or for commercial sale in the United States must be operated in conformity with current Good Manufacturing Practices (“cGMP”) regulations as required by the FDA and other comparable regulatory authorities in other countries and for certain products, the Drug Enforcement Agency.  The Company’s facilities are subject to scheduled periodic regulatory and customer inspections to ensure compliance with cGMP and other requirements applicable to such products.  A finding that the Company had materially violated these requirements could result in regulatory sanctions including, but not limited to, the FDA withholding approval of new drug applications or supplements and the denial of entry into the U.S. of products manufactured at non-compliant foreign facilities, the loss of a customer contract, the disqualification of data for client submissions to regulatory authorities and a mandated closing of the Company’s facilities.  Any such violations would have a material adverse effect on the Company’s business.  Cambrex’s customers are typically subject to the same, or similar, regulations and any such violations or other actions by regulatory agencies, including, but not limited to, plant shutdowns or product recalls that eliminate or reduce the Company’s sale of its products or services could negatively impact the Company’s business.

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The outsourcing trend in the preclinical and clinical stages of drug research and development may decrease, which could slow the Company’s growth.

The success of the Company’s business depends to a certain extent on the number of contracts and the size of the contracts that it may obtain from pharmaceutical companies. Over the past several years, the Company has benefited from increased levels of outsourcing by pharmaceutical companies of their drug R&D activities. A slowing of the outsourcing trend could result in a diminished growth rate in the Company’s sales and adversely affect its business, financial condition and results of operations.

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Item 6. 
Exhibits

 
1.
Exhibit 31.1 – Section 302 Certification Statement of the Chief Executive Officer.
 
2.
Exhibit 31.2 – Section 302 Certification Statement of the Chief Financial Officer.
 
3.
Exhibit 32    – Section 906 Certification Statements of the Chief Executive Officer and Chief Financial Officer.

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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.

   
CAMBREX CORPORATION
     
 
By
/s/ Gregory P. Sargen
 
   
Gregory P. Sargen
   
Vice President and Chief Financial Officer
   
(On behalf of the Registrant and as the
   
Registrant's Principal Financial Officer)

Dated:  November 4, 2009
 
 
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