Table of Contents

 

 

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 June 30, 2009

OR

 

¨ 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 000-30334

 

 

Angiotech Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

British Columbia, Canada   98-0226269

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification Number)

1618 Station Street

Vancouver, B.C. Canada

  V6A 1B6
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (604) 221-7676

 

 

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 (as amended, the “Exchange Act”) during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes   x     No   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes   ¨     No   ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes   ¨     No   x

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

85,136,725 Common Shares, no par value, as of August 7, 2009

 

 

 


Table of Contents

ANGIOTECH PHARMACEUTICALS, INC.

QUARTERLY REPORT ON FORM 10-Q

For the Three Months Ended June 30, 2009

TABLE OF CONTENTS

 

         Page
    PART I—FINANCIAL INFORMATION     

Item 1

 

Financial Statements:

  
 

Consolidated Balance Sheets as of June 30, 2009 (unaudited) and December 31, 2008

   1
 

Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2009 and 2008 (unaudited)

   2
 

Consolidated Statements of Stockholders’ Equity (Deficit) as of June 30, 2009 and 2008 (unaudited)

   3
 

Consolidated Statements of Cash Flows for the Three and Six Months Ended June 30, 2009 and 2008 (unaudited)

   4
 

Notes to Unaudited Consolidated Financial Statements

   5

Item 2

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   34

Item 3

 

Quantitative and Qualitative Disclosures about Market Risk

   56

Item 4

 

Controls and Procedures

   56
  PART II—OTHER INFORMATION   

Item 1

 

Legal Proceedings

   57

Item 1A

 

Risk Factors

   58

Item 2

 

Unregistered Sales of Equity Securities and Use of Proceeds

   74

Item 3

 

Defaults Upon Senior Securities

   74

Item 4

 

Submission of Matters to a Vote of Security Holders

   74

Item 5

 

Other Information

   75

Item 6

 

Exhibits

   76

SIGNATURES

   77


Table of Contents

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements

Angiotech Pharmaceuticals, Inc.

CONSOLIDATED BALANCE SHEETS

(All amounts expressed in thousands of U.S. dollars)

(Unaudited)

 

     June 30,
2009
    December 31,
2008
 

ASSETS

    

Current assets

    

Cash and cash equivalents [note 5]

   $ 50,658      $ 38,952   

Short-term investments [note 6]

     1,657        848   

Accounts receivable

     28,405        25,524   

Inventories [note 7]

     38,761        38,594   

Deferred income taxes, current portion

     3,520        3,820   

Prepaid expenses and other current assets

     4,475        5,234   
                

Total current assets

     127,476        112,972   
                

Long-term investments

     1,561        1,561   

Assets held for sale

     8,463        8,422   

Property, plant and equipment [note 8]

     47,293        49,108   

Intangible assets [note 9]

     183,230        195,477   

Deferred financing costs [note 11]

     12,398        11,363   

Other assets

     1,899        6,294   
                

Total assets

   $ 382,320      $ 385,197   
                

LIABILITIES AND STOCKHOLDERS’ DEFICIT

    

Current liabilities

    

Accounts payable and accrued liabilities [note 10]

   $ 44,615      $ 46,620   

Income taxes payable

     7,756        8,071   

Interest payable on long-term debt

     6,109        6,514   

Deferred revenue, current portion

     210        210   
                

Total current liabilities

     58,690        61,415   
                

Deferred revenue

     895        999   

Deferred leasehold inducement

     3,050        2,780   

Deferred income taxes

     37,863        40,577   

Other tax liabilities

     2,962        3,145   

Long-term debt [note 11]

     575,000        575,000   

Other liabilities

     904        1,154   
                

Total non-current liabilities

     620,674        623,655   
                

Commitments and contingencies [note 14]

    

Stockholders’ deficit

    

Share capital [note 13]

    

Authorized:

    

200,000,000 Common shares, without par value

    

50,000,000 Class I Preference shares, without par value

    

Common shares issued and outstanding:

    

June 30, 2009 – 85,126,725

    

December 31, 2008 – 85,121,983

     472,740        472,739   

Additional paid-in capital

     32,915        32,107   

Accumulated deficit

     (843,106     (843,673

Accumulated other comprehensive income

     40,407        38,954   
                

Total stockholders’ deficit

     (297,044     (299,873
                

Total liabilities and stockholders’ deficit

   $ 382,320      $ 385,197   
                

See accompanying notes to the consolidated financial statements

 

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Angiotech Pharmaceuticals, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS

(All amounts expressed in thousands of U.S. dollars, except share and per share data)

(Unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2009     2008     2009     2008  

REVENUE

        

Royalty revenue

   $ 16,996      $ 25,536      $ 34,107      $ 54,466   

Product sales, net

     47,179        50,533        93,316        98,259   

License fees

     398        53        25,450        105   
                                
     64,573        76,122        152,873        152,830   
                                

EXPENSES

        

License and royalty fees

     2,568        3,661        5,474        8,032   

Cost of products sold

     25,682        26,809        49,648        52,658   

Research and development

     6,833        18,584        12,930        34,889   

Selling, general and administration

     21,606        25,813        41,178        53,654   

Depreciation and amortization

     8,296        8,539        16,560        17,017   

In-process research and development

     —          —          —          2,500   
                                
     64,985        83,406        125,790        168,750   
                                

Operating (loss) income

     (412     (7,284     27,083        (15,920
                                

Other income (expenses):

        

Foreign exchange (loss) gain

     (1,441     140        (709     563   

Investment and other (expense) income

     (600     686        (615     1,442   

Interest expense on long-term debt

     (9,641     (10,941     (19,685     (23,061

Write-down / loss on investments

     —          (10,660     —          (10,660
                                

Total other expenses

     (11,682     (20,775     (21,009     (31,716
                                

(Loss) / income before income taxes

     (12,094     (28,059     6,074        (47,636

Income tax (recovery) / expense

     (217     (1,988     5,507        (5,802
                                

Net (loss) income

   $ (11,877   $ (26,071   $ 567      $ (41,834
                                

Basic and diluted net (loss) / income per common share:

   $ (0.14   $ (0.31   $ 0.01      $ (0.49
                                

Basic and diluted weighted average number of common shares outstanding (in thousands)

     85,122        85,122        85,122        85,114   
                                

See accompanying notes to the consolidated financial statements

 

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Angiotech Pharmaceuticals, Inc.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(All amounts expressed in thousands of U.S. dollars, except share data)

(Unaudited)

 

     Common Shares    Additional
paid-in
   Accumulated     Accumulated
other
comprehensive
    Comprehensive
loss
    Total
stockholders’
 
   Shares    Amount    capital    deficit     income       equity  

Balance at December 31, 2007

   85,073,983    $ 472,618    $ 29,669    $ (102,497   $ 42,282        $ 442,072   
                                             

Exercise of stock options for cash

   48,000      121               121   

Stock-based compensation

           817            817   

Net unrealized loss on available-for-sale securities, net of taxes (nil)

                (4,133   $ (4,133     (4,133

Cumulative translation adjustment

                10,583        10,583        10,583   

Net loss

              (15,763       (15,763     (15,763
                       

Comprehensive loss

                $ (9,313  
                                                   

Balance at March 31, 2008

   85,121,983    $ 472,739    $ 30,486    $ (118,260   $ 48,732        $ 433,697   
                                             

Stock-based compensation

           608            608   

Net unrealized loss on available-for-sale securities, net of taxes

                (2,235   $ (2,235     (2,235

Reclassification of net unrealized loss on available-for-sale securities, net of taxes (nil)

                10,656        10,656        10,656   

Cumulative translation adjustment

                9        9        9   

Net loss

              (26,071       (26,071     (26,071
                       

Comprehensive loss

                $ (17,641  
                                                   

Balance at June 30, 2008

   85,121,983    $ 472,739    $ 31,094    $ (144,331   $ 57,162        $ 416,664   
                                             

 

     Common Shares    Additional
paid-in
    Accumulated     Accumulated
other
comprehensive
    Comprehensive
income
    Total
stockholders’
 
   Shares    Amount    capital     deficit     income       (deficit)  

Balance at December 31, 2008

   85,121,983    $ 472,739    $ 32,107      $ (843,673   $ 38,954        $ (299,873
                                              

Stock-based compensation

           386              386   

Net unrealized gain on available-for-sale securities, net of taxes (nil)

               847      $ 847        847   

Cumulative translation adjustment

               (1,152     (1,152     (1,152

Net income

             12,444          12,444        12,444   
                      

Comprehensive income

               $ 12,139     
                                                    

Balance at March 31, 2009

   85,121,983    $ 472,739    $ 32,493      $ (831,229   $ 38,649        $ (287,348
                                              

Exercise of stock options

   4,742      1      (1           —     

Stock-based compensation

           423              423   

Net unrealized gain on available-for-sale securities, net of taxes (nil)

               (38   $ (38     (38

Cumulative translation adjustment

               1,796        1,796        1,796   

Net loss

             (11,877       (11,877     (11,877
                      

Comprehensive loss

               $ (10,119  
                                                    

Balance at June 30, 2009

   85,126,725    $ 472,740    $ 32,915      $ (843,106   $ 40,407        $ (297,044
                                              

See accompanying notes to the consolidated financial statements

 

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Angiotech Pharmaceuticals, Inc.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(All amounts expressed in thousands of U.S. dollars)

(Unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2009     2008     2009     2008  

OPERATING ACTIVITIES

        

Net (loss) income

   $ (11,877   $ (26,071   $ 567      $ (41,834

Adjustments to reconcile net loss to cash provided by operating activities:

        

Depreciation and amortization

     9,117        9,654        18,225        19,128   

Loss on disposition of property and equipment

     24        12        67        12   

Write-down / loss on redemption of investments

     —          10,656        —          10,656   

Write-down and other deferred financing charges

     643        —          643        —     

Unrealized foreign exchange loss (gain)

     (496     60        (642     48   

Deferred leasehold inducements

     (77     (59     (136     (118

Deferred income taxes

     (1,013     315        (2,596     (5,365

Stock-based compensation expense

     423        607        809        1,424   

Deferred revenue

     (52     97        (105     44   

Non-cash interest expense

     750        559        1,368        1,117   

In-process research and development

     —          —          —          2,500   

Net change in non-cash working capital items relating to operations [note 18]

     (4,959     2,183        1,672        (6,041
                                

Cash (used in) provided by operating activities

     (7,517     (1,987     19,872        (18,429
                                

INVESTING ACTIVITIES

        

Purchase of property, plant and equipment

     (946     (2,388     (1,689     (5,785

Purchase of intangible assets

     (2,500     (1,000     (2,500     (1,000

Loans advanced

     (1,200     —          (1,200     —     

In-process research and development

     —          —          —          (2,500

Other

     12        150        251        304   
                                

Cash used in investing activities

     (4,634     (3,238     (5,138     (8,981
                                

FINANCING ACTIVITIES

        

Deferred financing charges and costs

     (1,386     (1,536     (2,976     (1,621

Proceeds from stock options exercised

     —          —          —          121   
                                

Cash used in financing activities

     (1,386     (1,536     (2,976     (1,500
                                

Effect of exchange rate changes on cash and cash equivalents

     (328     (116     (52     499   

Net (decrease) increase in cash and cash equivalents

     (13,865     (6,877     11,706        (28,411

Cash and cash equivalents, beginning of period

     64,523        69,792        38,952        91,326   
                                

Cash and cash equivalents, end of period

   $ 50,658      $ 62,915      $ 50,658      $ 62,915   
                                

See accompanying notes to the consolidated financial statements

 

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Angiotech Pharmaceuticals, Inc.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

(All tabular amounts expressed in thousands of U.S. dollars, except share and per share data)

(Unaudited)

 

1. BASIS OF PRESENTATION

We prepared these unaudited interim consolidated financial statements in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for the presentation of interim financial information. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K, as amended by our Form 10-K/A, for the year ended December 31, 2008.

In management’s opinion, all adjustments (which include reclassification and normal recurring adjustments) necessary to present fairly the consolidated balance sheets, consolidated statements of operations, consolidated statements of stockholders’ deficit and consolidated statements of cash flows at June 30, 2009 and for all periods presented, have been made. In connection with the preparation of the interim financial statements and in accordance with the recently issued Statement of Financial Accounting Standards (“SFAS”) No. 165, Subsequent Events, we evaluated subsequent events after the balance sheet date of June 30, 2009 through August 7, 2009, which is the date the financial statements were issued. The results of operations for the three and six months ended June 30, 2009 may not necessarily be indicative of the results for the full year ending December 31, 2009.

All amounts herein are expressed in U.S. dollars unless otherwise noted. The year end balance sheet data was derived from audited financial statements but does not include all of the disclosures required under U.S. GAAP.

 

2. SIGNIFICANT ACCOUNTING POLICIES

Other than the changes in accounting policies described below in these interim consolidated financial statements, all accounting policies are the same as described in note 2 to our audited consolidated financial statements for the year ended December 31, 2008 included in our 2008 Annual Report on Form 10-K, as amended by our Form 10-K/A, filed with the SEC.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities and disclosures of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the reported periods. Estimates are used when accounting for the collectability of receivables, valuing deferred tax assets, provisions for inventory obsolescence, accounting for manufacturing variances, determining stock-based compensation expense and reviewing long-lived assets for impairment. Actual results may differ materially from these estimates.

a) Liquidity risk

Liquidity risk is the risk that the Company will encounter difficulty in meeting obligations associated with its financial liabilities and other contractual obligations. We monitor and manage our liquidity risk by preparing rolling cash flow forecasts, monitoring the condition and value of assets available to be used as security in financing arrangements, seeking flexibility in financing arrangements and establishing programs to monitor and maintain compliance with terms of financing agreements. A key component of managing liquidity risk is also ensuring that operating cash flows are optimized. Our principal objective in managing liquidity risk is to maintain cash and access to cash at levels sufficient to meet our day-to-day operating requirements.

For the six months ended June 30, 2009, we reported a balance of cash and cash equivalents (“cash resources”) of $50.7 million, which represented a net increase in cash resources of $11.7 million as compared to December 31, 2008. During the three months ended June 30, 2009, we used $7.5 million to fund operating activities; $4.6 million to fund investing activities and $1.4 million for financing activities. For the six months ended June 30, 2009, operating activities provided $19.9 million, and we used $5.1 million to fund investing activities and $3.0 million for financing activities. Our cash resources are used to support clinical studies, research and development initiatives, sales and marketing initiatives, working capital requirements, debt servicing requirements and for general corporate costs. Our cash resources may also be used to fund acquisitions of, or investments in, businesses, products or technologies that expand, complement or are otherwise related to our business.

During 2008 and continuing in 2009, we undertook various initiatives and developed a plan to manage our operating and liquidity risks including:

 

   

Reduction of research and development activities and reduction in staffing within the clinical and research and development departments.

 

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Gross margin improvement initiatives including the transfer of certain manufacturing operations to lower cost regions and the closure of the Syracuse, NY operations.

 

   

Cost containment initiatives including staffing reductions in general and administrative departments, a supplier concession program and other cost reduction initiatives.

 

   

Selective reduction in certain sales and marketing investments and investments in medical affairs.

 

   

Postponement of selected planned capital expenditures.

 

   

Obtained a financing commitment from Wells Fargo Foothill, LLC (“Wells Fargo”) as described below and in Note 11.

 

   

Completed an Amended and Restated Distribution and License Agreement with our partner Baxter International Inc. (“Baxter”) for which we received an up-front payment of $25.0 million in lieu of future royalty and milestone obligations related to the existing formulations of COSEAL or any future products under the terms of the Amended and Restated Distribution and License Agreement.

We face a number of risks and uncertainties that may significantly impact our ability to generate cash flows from our operations and to fund our capital expenditures and future opportunities that might be available to us. These risks and uncertainties may materially impact our liquidity position in 2009 and future years. The more significant risks and uncertainties that have and may continue to impact our future operating results, cash flows and liquidity position are as follows:

 

   

Revenue in our Pharmaceutical Technologies segment declined $8.2 million for the three months ended June 30, 2009, as compared to the same period in 2008, primarily as a result of decrease in royalty revenue derived from sales by Boston Scientific Corporation (“BSC”) of TAXUS ® coronary stent systems primarily due to new competitive entrants into the U.S. drug-eluting stent market beginning in 2008. The decrease in royalty revenue derived from sales by BSC of TAXUS ® coronary stent systems was $20.0 million for the six months ended June 30, 2009, as compared to the same period in 2008. However, our Pharmaceutical Technologies segment revenues improved by $5.0 million for the six months ended June 30, 2009 as compared to the same period in 2008, primarily as a result of a one-time license fee income from Baxter of $25.0 million for an Amended and Restated Distribution and License Agreement. Under our license agreement with BSC, we do not control the direct or indirect sales of the TAXUS products. We expect the impact of new competitive conditions to be reflected through the full year 2009 and in subsequent years, which, accordingly, is expected to result in lower revenues and cash flows derived from sales of TAXUS in 2009 and subsequent years.

 

   

Revenue from the Medical Products segment for the three and six months ended June 30, 2009 was $47.2 million and $93.3 million, respectively, compared to $50.5 million and $98.3 million, respectively in the same periods in 2008. The current economic environment and difficult credit markets and liquidity environment may have an impact on our customers and therefore on our product sales in 2009 and future years. In light of these conditions, we are continuously monitoring and managing our sales activities; however, several factors that may affect our revenues are not within our control. In addition, we continue to implement our marketing plans for our newer promoted brand products such as the Quill SRS product line, with the expectation of growth in the second half of 2009. It is possible that the expected growth in revenue in the second half of 2009 for these newer product lines may not be achieved and revenues for other products may decline.

 

   

Our gross margins for product sales were 46% and 47%, respectively for the three and six months ended June 30, 2009 compared to 47% and 46%, respectively for the three and six months ended June 30, 2008. Gross margins for the six months ended June 30, 2009 compared to the same period in 2008 were positively impacted by a relative increase in sales of higher margin product lines and the continued launch of certain new, higher margin product lines for which there were no material sales in the comparable period in 2008. However, these positive factors were offset by unfavorable production variances at our Aguadilla, Puerto Rico facility. During the remainder of 2009, we may have further changes in the mix or volume of products to be purchased by our customers. In addition, the new manufacturing facilities will be completing their initial full cycles of production. There can be no assurance that these gross margin improvements will continue in the remainder of 2009 or thereafter.

 

   

We have implemented initiatives to reduce our research and development costs, selling, general and administrative costs and capital expenditures for 2009. We continue to closely monitor costs in relation to sales activity and forecasted revenues. We expect that some limited future cost reductions could be achieved if forecasted revenues are not achieved. However, such cost reductions may affect our future opportunities. In addition, as reported in note 14, we have entered into certain commitments and are exposed to certain contingencies for which the outcome is not necessarily within our control. Acceleration of research and development activities under collaboration agreements by counterparties and any unexpected outcomes in respect of contingencies may require payments earlier than they are currently expected.

 

   

As noted in Note 11(c), on May 29, 2009, we entered into amendment to our senior secured term loan and revolving credit facility with Wells Fargo that we had previously announced in March 2009. This financing originally included a delayed draw secured term loan facility of up to $10.0 million and a secured revolving credit facility, with a borrowing base

 

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derived from the value of certain of our finished goods inventory and accounts receivable, providing up to an additional $22.5 million in available credit, subject to certain terms and conditions. The amendment included, among other things, early termination of the term loan facility, which was originally scheduled to terminate on August 31, 2009. The amendment also expanded the definition of Permitted Investments and eliminated a $2.5 million availability block, increasing the total available credit under the revolving credit facility to $25.0 million (subject to a borrowing base formula derived from the value of certain of our finished goods inventory and accounts receivable). As of June 30, 2009, the amount of financing available under the revolving credit facility was approximately $10.7 million and there were no borrowings outstanding under the revolving credit facility. The secured credit facility includes certain covenants and restrictions with respect to our operations and requires us to maintain certain levels of adjusted earnings before interest, taxes, depreciation and amortization (“Adjusted EBITDA”) and interest coverage ratios, among other terms and conditions. These covenants may limit our ability to borrow under the revolving credit facility or may require repayment. While we expect to be able to maintain the Adjusted EBITDA and interest coverage covenants during 2009, it is possible that events and circumstances may occur that may affect our ability to operate our business within the restrictions proposed by the financial covenants and other restrictions relating to the revolving credit facility.

 

   

Our future interest payments related to our existing long-term debt continues to be significant. During the three and six months ended June 30, 2009, we incurred interest expense of $9.6 million and $19.7 million respectively on the outstanding long-term debt obligations, as compared to $10.9 million and $23.0 million respectively for the same periods in 2008. Additional interest expense will be incurred if the revolving credit facility described above is utilized. The Senior Floating Rate Notes due 2013 (“Floating Rate Notes”) reset quarterly to an interest rate of 3-month London Interbank Offered Rate (“LIBOR”) plus 3.75% and bore an interest rate of 4.41% at June 30, 2009 compared to 6.43% at June 30, 2008. Volatility in the LIBOR rates and interest rates in general are outside of our control. We do not use derivatives to hedge against this interest rate risk and it is possible that volatility in the LIBOR rate will continue throughout fiscal 2009. Changes in the LIBOR rate will affect interest costs.

 

   

We are significantly leveraged and have significant future interest payments. We are continuing to evaluate a range of financial and strategic alternatives with our financial and legal advisors with respect to our capital structure. There can be no assurance that we will be able to consummate any new financing or other transaction that would be favourable to us. Actions to pursue alternative financing structures may require us to incur additional costs, which may impact our cash and liquidity position.

While we believe that we have developed planned courses of action and identified other opportunities to mitigate the operating and liquidity risks outlined above, there can be no assurance that we will be able to achieve any or all of the opportunities we have identified or obtain sufficient liquidity to execute our business plan. Furthermore, there may be other material risks and uncertainties that may impact our liquidity position that we have not yet identified.

b) Recently adopted accounting policies

In December 2007, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 141 (Revised 2007), Business Combinations, or SFAS No. 141(R). SFAS No. 141(R) will change the accounting for business combinations. Under SFAS No. 141(R), an acquiring entity will be required to recognize all the assets acquired and liabilities assumed in a transaction at the acquisition-date fair value with limited exceptions. SFAS No. 141(R) will change the accounting treatment and disclosure for certain specific items in a business combination. SFAS No. 141(R) applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. We have adopted this standard but the impact on accounting for business combinations will be dependent upon future acquisitions.

On April 1, 2009, the FASB issued FASB Staff Position (“FSP”) FAS No. 141(R)-1, Accounting for Assets Acquired and Liabilities Assumed in a Business Combination That Arise from Contingencies, to amend and clarify the initial recognition and measurement, subsequent measurement and accounting, and related disclosures arising from contingencies in a business combination under SFAS No. 141(R). FSP FAS No. 141(R)-1 applies to all assets acquired and liabilities assumed in a business combination that arise from contingencies that would be within the scope of FAS No. 5 if not acquired or assumed in a business combination, except for assets or liabilities arising from contingencies that are subject to specific guidance in FAS 141(R). We have adopted this standard but the impact on accounting for business combinations will be dependent upon future acquisitions.

In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements—An Amendment of ARB No. 51, or SFAS No. 160. SFAS No. 160 establishes new accounting and reporting standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a subsidiary. SFAS No. 160 is effective for fiscal years beginning on or after December 15, 2008. Adopting this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In November 2007, the Emerging Issues Task Force issued EITF Issue 07-01, Accounting for Collaborative Arrangements or EITF Issue 07-01. EITF Issue 07-01 requires collaborators to present the results of activities for which they act as the principal on a gross basis and report any payments received from (made to) other collaborators based on other applicable GAAP or, in the

 

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absence of other applicable GAAP, based on analogy to authoritative accounting literature or a reasonable, rational, and consistently applied accounting policy election. Further, EITF Issue 07-01 clarified that the determination of whether transactions within a collaborative arrangement are part of a vendor-customer (or analogous) relationship subject to Issue 01-9, Accounting for Consideration Given by a Vendor to a Customer. EITF Issue 07-01 is effective for fiscal years beginning December 15, 2008. Adoption of this standard has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities or SFAS No. 161. SFAS No. 161 amends and expands the disclosure requirements of SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities. It requires qualitative disclosures about objectives and strategies for using derivatives, quantitative disclosures about fair value amounts of gains and losses on derivative instruments, and disclosures about credit-risk-related contingent features in derivative agreements. This statement is effective for financial statements issued for fiscal years beginning after November 15, 2008. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

In April 2008, the FASB issued FSP FAS No. 142-3, Determination of the Useful Life of Intangible Assets, or FSP FAS No. 142-3. FSP FAS No. 142-3 amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets. The intent of the position is to improve the consistency between the useful life of a recognized intangible asset under SFAS No. 142 and the period of expected cash flows used to measure the fair value of the intangible asset. FSP FAS 142-3 is effective for fiscal years beginning after December 15, 2008. Adoption of this standard has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In September 2008, the FASB issued FSP 133-1 and FASB Interpretation Number (FIN) 45-4, Disclosures about Credit Derivatives and Certain Guarantees: An Amendment of FASB Statement No. 133 and FASB Interpretation No. 45; and Clarification of the Effective Date of FASB Statement No. 161. FSP 133-1 and FIN 45-4 amends disclosure requirements for sellers of credit derivatives and financial guarantees. It also clarifies the disclosure requirements of SFAS No. 161 and is effective for quarterly periods beginning after November 15, 2008, and fiscal years that include those periods. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

In December 2008, the FASB issued FSP SFAS No. 140-4 and FIN No. 46R-8, Disclosures by Public Entities (Enterprises) about Transfers of Financial Assets and Interests in Variable Interest Entities. This statement increases the disclosure requirements regarding continuing involvement with financial assets that have been transferred, as well as the company’s involvement with variable interest entities. The FSP is effective for financial statements issued for interim periods ending after December 15, 2008. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

In June 2008, the EITF Issue 08-3, Accounting for Lessees for Maintenance Deposits under Lease Arrangements, or EITF Issue 08-3 provides guidance for accounting for nonrefundable maintenance deposits. It also provides revenue recognition accounting guidance for the lessor. EITF Issue 08-3 is effective for fiscal years beginning after December 15, 2008. Adopting this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In June 2008, the EITF reached a consensus on EITF Issue 08-4, Transition Guidance for Conforming Changes to EITF Issue 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios. Subsequent to the issuance of EITF Issue 98-5, certain portions of the guidance contained in EITF Issue 98-5 were nullified by EITF Issue 00-27, Application of EITF Issue 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios’. However, the portions of EITF Issue 98-5 that were nullified by EITF Issue 00-27 were not specifically identified in EITF Issue 98-5, nor were the illustrative examples in EITF Issue 98-5 updated for the effects of EITF Issue 00-27. EITF Issue 08-4 specifically addresses the conforming changes to EITF Issue 98-5 and provides transition guidance for the conforming changes. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In June 2008, the FASB ratified EITF Issue 07-5, Determining Whether an Instrument (or an Embedded Feature) is Indexed to an Entity’s Own Stock. EITF Issue 07-5 provides that an entity should use a two step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. It also clarifies the impact of foreign currency denominated strike prices and market-based employee stock option valuation instruments on the evaluation. EITF Issue 07-5 is effective for fiscal years beginning after December 15, 2008. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

 

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In September 2008, the FASB ratified EITF Issue 08-5, Issuer’s Accounting for Liabilities Measured at Fair Value With a Third-Party Credit Enhancement. EITF Issue 08-5 provides guidance for measuring liabilities issued with an attached third-party credit enhancement (such as a guarantee). It clarifies that the issuer of a liability with a third-party credit enhancement should not include the effect of the credit enhancement in the fair value measurement of the liability. EITF Issue 08-5 is effective for the first reporting period beginning after December 15, 2008. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In November 2008, the EITF Issue 08-6, Equity method Investment Accounting Considerations, or EITF Issue 08-6 addresses a number of matters associated with the impact of SFAS No. 141(R) and SFAS No. 160 on the accounting for equity method investments including initial recognition and measurement and subsequent measurement issues. EITF Issue 08-6 is effective, on a prospective basis, for fiscal years beginning after December 15, 2008 and interim periods within those fiscal years. Adopting this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In November 2008, the EITF Issue 08-07, Accounting for Defensive Intangible Assets, or EITF Issue 08-7 provides guidance for accounting for defensive intangible assets subsequent to their acquisition in accordance with SFAS No. 141R and SFAS No. 157 including the estimated useful life that should be assigned to such assets. EITF Issue 08-7 is effective for intangible assets acquired on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. We have adopted this standard and the impact on accounting for defensive intangible assets will be dependent upon future acquisitions.

On January 12, 2009, the FASB issued FSP EITF No. 99-20-1, Amendments to the Impairment Guidance of EITF Issue 99-20. The FSP eliminates the requirement that a holder’s best estimate of cash flows be based upon those “that a market participant” would use. Instead, the FSP requires that an other-than-temporary impairment be recognized through earnings when it is probable that there has been an adverse change in the holder’s estimated cash flows from the cash flows previously projected. The Staff Position is effective for the first interim period or fiscal year ending after December 15, 2008, and each interim and annual period thereafter. Retroactive application to a prior interim period is not permitted. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In April 2009, the FASB issued FSP FAS No. 107-1 and APB 28-1, Interim Disclosures about Fair Value of Financial Instruments, or FSP FAS 107-1. FSP FAS 107-1 amends the disclosure requirements of FAS No. 107, Disclosures about Fair Value of Financial Instruments, for interim reporting periods of publicly traded companies as well as in annual financial statements. FSP FAS 107 requires public companies to disclosure the fair value of its financial instruments whenever it issues summarized financial information for interim reporting periods. FSP FAS No. 107-1 is effective for interim periods beginning after June 15, 2009. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

In April 2009, the FASB issued FSP FAS No. 115-2 and FAS No. 124-2, Recognition and Presentation of Other-than-Temporary Impairments, or FSP FAS No. 115-2. FSP FAS No. 115-2 amends the impairment guidance for certain debt securities and will require an investor to assess the likelihood of selling the security prior to recovering the cost basis. If the investor is able to meet the criteria to assert that it will not have to sell the security before recovery, impairment charges related to non-credit losses would be reflected in other comprehensive income. FSP FAS 115-2 is effective for interim periods beginning after June 15, 2009. Adoption of this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In April 2009, the FASB issued FSP FAS No. 157-4, Determining Fair Value When the Volume and Level of Activity for Asset or Liability have significantly Decreased and Identifying Transactions that are Not Orderly, or FSP FAS No. 157-4. FSP FAS No. 157-4 amends FAS No. 157, Fair Value Measurements, to provide additional guidance on fair value measurements in inactive markets. The new approach is designed to address whether a market is inactive, and if so, whether a transaction in that market should be considered distressed. FSP FAS No. 157-4 provides additional guidance on how fair value measurements might be determined in an active market. FSP FAS No. 157-4 is effective for interim periods beginning after June 15, 2009 and shall be applied prospectively. Adoption of this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In May 2009 the FASB issued SFAS No. 165, Subsequent Events. SFAS No. 165 establishes general standards for the accounting and disclosure of events which occur after the balance sheet date but before the financial statements are issued or are available for issuance. This standard is effective for interim or annual periods ending after June 15, 2009. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

 

3. RECENT ACCOUNTING PRONOUNCEMENTS

In June 2009 the FASB issued SFAS No. 166, Accounting for Transfers of Financial Assets to amend SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities. The new standard features the

 

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following changes: elimination of the qualifying special purpose entity concept, introduction of new criteria for the recognition and derecognition of financial asset transfers eligible for sale accounting, and extension of disclosure requirements. SFAS No. 166 is applicable to all financial asset transfers occurring from January 1, 2010. We are assessing the potential impact that the adoption of SFAS 166 may have on our consolidated financial position, results of operations or cash flows.

In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R) – Consolidation of Variable Interest Entities (“VIE’s”). The new standard eliminates the QSPE exemption and defines a new approach for assessing whether VIE’s should be consolidated. SFAS No. 167 is effective for annual and interim periods beginning after November 15, 2009. We are assessing the potential impact that the adoption of SFAS 167 may have on our consolidated financial position, results of operations or cash flows.

 

4. FINANCIAL INSTRUMENTS AND FINANCIAL RISK

For certain of our financial assets, and liabilities, including cash and cash equivalents, accounts receivable, and accounts payable and accrued liabilities, the carrying amounts approximate fair value due to their short-term nature. The fair value of the short-term investments approximates $1.6 million as at June 30, 2009 (December 31, 2008—$0.8 million). The total fair value of the long-term debt approximates $387.5 million (December 31, 2008—$224.2 million) and has a carrying value of $575.0 million as at June 30, 2009 and as at December 31, 2008.

The fair values of the short-term investments and long-term debt is based on quoted market prices at June 30, 2009 and at December 31, 2008.

Financial risk includes interest rate risk, exchange rate risk and credit risk:

 

   

Interest rate risk arises due to our long-term debt bearing fixed and variable interest rates. The interest rate on the Floating Rate Notes is reset quarterly to 3-month LIBOR plus 3.75%. These Floating Rate Notes currently bear interest at a rate of 4.41%. We do not use derivatives to hedge against interest rate risks.

 

   

Foreign exchange rate risk arises as a portion of our investments, revenues and expenses are denominated in currencies other than U.S. dollars. Our financial results are subject to the variability that arises from exchange rate movements in relation to the U.S. dollar, and is primarily limited to the Canadian dollar, the Swiss franc, the Euro, the Danish krone and the UK pound sterling. Foreign exchange risk is primarily managed by satisfying foreign denominated expenditures with cash flows or assets denominated in the same currency.

 

   

Credit risk arises as we provide credit to our customers in the normal course of business. We perform credit evaluations of our customers on a continuing basis and the majority of our trade receivables are unsecured. The maximum credit risk loss that we could face is limited to the carrying amount of accounts receivable. Concentrations of credit risk with respect to trade accounts receivable are limited due to the large number of customers and their dispersion across many geographic areas. However, a significant amount of trade accounts receivable is with the national healthcare systems of several countries. Efforts by governmental and third-party payers to reduce health care costs or the announcement of legislative proposals or reforms to implement government controls could impact our credit risk. Although we do not currently foresee a significant credit risk associated with these receivables, collection is dependent to some extent upon the financial stability of those countries’ national economies. At June 30, 2009, accounts receivable is net of an allowance for uncollectible accounts of $257,000 (December 31, 2008 – $270,000).

 

5. CASH AND CASH EQUIVALENTS

Cash and cash equivalents includes the following:

 

     June 30,
2009
   December 31,
2008

U.S. dollars

   $ 40,099    $ 21,866

Canadian dollars

     1,318      3,942

Swiss franc

     1,355      3,053

Euro

     5,280      5,263

Danish krone

     1,136      2,022

Other

     1,470      2,806
             
   $ 50,658    $ 38,952
             

 

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6. SHORT-TERM INVESTMENTS

 

June 30, 2009

   Cost    Gross Unrealized
Gains
   Carrying value

Short-term investments:

        

Available-for-sale equity securities

   $ 848    $ 809    $ 1,657
                    

December 31, 2008

   Cost    Gross Unrealized
Gains
   Carrying value

Short-term investments:

        

Available-for-sale equity securities

   $ 848    $ —      $ 848
                    

 

7. INVENTORIES

 

     June 30,
2009
   December 31,
2008

Raw materials

   $ 9,854    $ 10,357

Work in process

     14,531      12,232

Finished goods

     14,376      16,005
             
   $ 38,761    $ 38,594
             

 

8. PROPERTY, PLANT AND EQUIPMENT

 

June 30, 2009

   Cost    Accumulated
Depreciation
   Net book
value

Land

   $ 4,790    $ —      $ 4,790

Buildings

     14,336      1,597      12,739

Leasehold improvements

     18,304      5,623      12,681

Manufacturing equipment

     20,064      7,851      12,213

Research equipment

     7,370      4,823      2,547

Office furniture and equipment

     3,703      2,793      910

Computer equipment

     9,022      7,609      1,413
                    
   $ 77,589    $ 30,296    $ 47,293
                    

 

December 31, 2008

   Cost    Accumulated
depreciation
   Net book
Value

Land

   $ 4,755    $ —      $ 4,755

Buildings

     14,200      1,257      12,943

Leasehold improvements

     17,944      5,108      12,836

Manufacturing equipment

     18,815      6,302      12,513

Research equipment

     7,316      4,363      2,953

Office furniture and equipment

     3,698      2,486      1,212

Computer equipment

     9,000      7,104      1,896
                    
   $ 75,728    $ 26,620    $ 49,108
                    

Depreciation expense, including depreciation expense allocated to cost of goods sold, for the three and six months ended June 30, 2009 amounted to $1.7 million and $3.5 million, respectively ($2.1 million and $4.0 million, respectively for the three and six months ended June 30, 2008).

 

9. INTANGIBLE ASSETS

 

June 30, 2009

   Cost    Accumulated
amortization
   Net book
value

Acquired technologies

   $ 130,561    $ 58,497    $ 72,064

Customer relationships

     110,557      36,941      73,616

In-licensed technologies

     55,851      27,442      28,409

Trade names and other

     14,428      5,287      9,141
                    
   $ 311,397    $ 128,167    $ 183,230
                    

 

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December 31, 2008

           Cost           

 

Accumulated
Amortization

  

 

    Net book    
value

Acquired technologies

   $ 128,061    $ 52,303    $ 75,758

Customer relationships

     110,509      32,426      78,083

In-licensed technologies

     55,829      24,104      31,725

Trade names and other

     14,410      4,499      9,911
                    
   $ 308,809    $ 113,332    $ 195,477
                    

Amortization expense for the three and six months ended June 30, 2009 amounted to $7.4 million and $14.8 million, respectively ($7.2 million and $15.2 million, respectively for the three and six months ended June 30, 2008).

 

10. ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

 

         June 30, 2009        December 31, 2008

Trade accounts payable

   $ 5,209    $ 4,700

Accrued license and royalty fees

     9,235      4,196

Employee-related accruals

     12,477      17,382

Accrued professional fees

     4,612      9,888

Accrued contract research

     3,403      2,121

Other accrued liabilities

     9,679      8,333
             
   $ 44,615    $ 46,620
             

 

11. LONG-TERM DEBT

 

  (a) Issued and Outstanding Long-Term Debt

 

         June 30, 2009        December 31, 2008

Senior Floating Rate Notes

   $ 325,000    $ 325,000

7.75% Senior Subordinated Notes

     250,000      250,000

Revolving Credit Facility (Note 11(c))

     —        —  
             
   $ 575,000    $ 575,000
             

 

  (b) Deferred Financing Costs

Deferred financing costs are capitalized and amortized on a straight-line basis, which approximates the effective interest rate method, to interest expense over the life of the debt instruments.

 

June 30, 2009

           Cost            Accumulated
Amortization
       Net Book    
Value

Debt issuance costs relating to:

        

Senior Floating Rate Notes

   $ 8,000    $ 2,932    $ 5,068

7.75% Senior Subordinated Notes

     8,718      3,542      5,176

Revolving Credit Facility (Note 11 (c))

     2,403      249      2,154
                    
   $ 19,121    $ 6,723    $ 12,398
                    

December 31, 2008

   Cost   

 

Accumulated
Amortization

  

 

Net Book
Value

Debt issuance costs relating to:

        

Senior Floating Rate Notes

   $ 8,000    $ 2,358    $ 5,642

7.75% Senior Subordinated Notes

     8,718      2,997      5,721
                    
   $ 16,718    $ 5,355    $ 11,363
                    

 

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  (c) Revolving Credit Facility

On May 29, 2009, we entered into an amendment to our senior secured term loan and revolving credit facility with Wells Fargo that we had previously announced in March 2009. This financing originally included a delayed draw secured term loan facility of up to $10.0 million and a secured revolving credit facility, with a borrowing base derived from the value of certain of our finished goods inventory and accounts receivable, providing up to an additional $22.5 million in available credit, subject to certain terms and conditions. The amendment included, among other things, early termination of the term loan facility, which was originally scheduled to terminate on August 31, 2009. The amendment also expanded the definition of permitted investments and eliminated a $2.5 million availability block, increasing the total available credit under the revolving credit facility to $25.0 million (subject to a borrowing base formula derived from the value of certain of our finished goods inventory and accounts receivable). As of June 30, 2009, the amount of financing available under the revolving credit facility was approximately $10.7 million and there were no borrowings outstanding under the revolving credit facility.

In connection with the early termination of the term loan facility, we expensed the unamortized balance of debt issuance costs associated with the secured term loan, resulting in a write-down of deferred financing costs of $0.6 million.

At any time, the amount of financing available under the revolving credit facility, which is secured by certain of our inventory and accounts receivable assets may be significantly less than $25.0 million and is expected to fluctuate from month to month with changes in levels of finished goods inventory and accounts receivable. Any borrowings outstanding under the revolving credit facility bear interest ranging from LIBOR + 3.25% to LIBOR +3.75%, with a minimum Base LIBOR Rate of 2.25%. As the minimum Base LIBOR Rate under the revolving credit facility is 2.25% and the LIBOR was 0.66% on June 30, 2009, a 0.5% increase or decrease in the LIBOR as of June 30, 2009 would have no impact on interest payable under the credit facility.

The revolving credit facility includes certain covenants and restrictions with respect to our operations and requires us to maintain certain levels of Adjusted EBITDA and interest coverage ratios, among other terms and conditions. Repayment of any amounts drawn under the revolving credit facility can be made at certain points in time with ultimate maturity being February 27, 2013. Prepayments made under the revolving credit facility in certain circumstances, cannot be re-borrowed by us. The purpose of this facility is to provide additional liquidity and capital resources for working capital and general corporate purposes.

 

12. INCOME TAXES

For the three and six months ended June 30, 2009 we recorded an income tax recovery of $0.2 million and an income tax expense of $5.5 million, respectively, compared to income tax recoveries of $2.0 million and $5.8 million for the three and six months ended June 30, 2008, respectively. The income tax recovery for the three months ended June 30, 2009 was primarily due to the amortization of identifiable intangible assets. The income tax expense for the six months ended June 30, 2009 also includes a $6.1 million write-off of deferred charges relating to taxes paid in prior years in connection with an inter-company transfer of the CoSeal intellectual property underlying the transaction with Baxter.

The effective tax rate for the three and six months ended June 30, 2009 was 1.8% and 90.7%, respectively compared to an effective tax rate of 7.1% and 12.2% for the same period in 2008. The effective tax rate for the current period was lower than the statutory Canadian tax rate of 30.0% and was primarily due to valuation allowances on net operating losses.

 

13. SHARE CAPITAL

During the three and six months ended June 30, 2009, we issued 4,742 (48,000 for the three and six months ended June 30, 2008) common shares upon exercises of stock options. We issue new shares to satisfy stock option exercises.

(a) Stock Options

Angiotech Pharmaceuticals, Inc.

In June 2006, the shareholders approved the adoption of the 2006 Stock Incentive Plan (“2006 Plan”) which superseded our previous stock option plans. The 2006 Plan incorporated all of the options granted under our previous stock option plans and, in total, provides for the issuance of non-transferable stock-based awards to purchase up to 13,937,756 common shares to employees, officers, Board of Directors, and persons providing ongoing management or consulting services. The 2006 Plan provides for, but does not require, the granting of tandem stock appreciation rights that at the option of the holder may be exercised instead of the underlying option. When the tandem stock appreciation right is exercised, the underlying option is cancelled. The tandem stock appreciation rights are settled in equity and the optionee receives common shares with a fair market value equal to the excess of the fair value of the shares subject to the option at the time of exercise (or the portion thereof so exercised) over the aggregate option price of the shares set forth in the option agreement. The exercise of tandem stock

 

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appreciation rights is treated as the exercise of the underlying option. The exercise price of the options is fixed by the Board of Directors, but will generally be at least equal to the market price of the common shares at the date of grant, and for options issued under the 2006 Plan and our 2004 Stock Incentive Plan (“2004 Plan”), the term may not exceed five years. For options granted under stock option plans prior to the 2004 Plan, the term did not exceed 10 years. Options granted are also subject to certain vesting provisions. Options generally vest monthly after being granted over varying terms from 2 to 4 years. Any one person is permitted, subject to the approval of the Board of Directors, to receive options and tandem SARs to acquire up to 5% of our issued and outstanding common shares.

A summary of CDN dollar stock option transactions is as follows:

 

     No. of
optioned
shares
    Weighted average
exercise price

(in CDN$)
   Weighted average
remaining
contractual term
(years)
   Aggregate
intrinsic
value
(in CDN$)

Outstanding at December 31, 2007

   7,675,944      $ 15.55    3.16    $ 177

Exercised

   (48,000     2.50      

Forfeited

   (127,000     15.74      
                        

Outstanding at March 31, 2008

   7,500,944        15.63    2.93      —  
                        

Exercisable and expected to vest at March 31, 2008

   6,272,728        16.60    2.75      —  
                        

Forfeited

   (118,913     16.51      
                        

Outstanding at June 30, 2008

   7,382,031        15.61    2.69      32
                        

Exercisable and expected to vest at June 30, 2008

   6,321,522      $ 16.49    2.50    $ 32
                        
     No. of
optioned
shares
    Weighted average
exercise price

(in CDN$)
   Weighted average
remaining
contractual

term (years)
   Aggregate
intrinsic
value
(in CDN$)

Outstanding at December 31, 2008

   7,644,632      $ 12.82    2.67    $ 196

Granted

   1,434,000        0.38      

Forfeited

   (728,732     22.80      
                        

Outstanding at March 31, 2009

   8,349,900        9.81    3.07      1,059
                        

Exercisable and expected to vest at March 31, 2009

   7,242,730        9.81    2.52      50
                        

Granted

   10,000        2.31      

Exercised

   (4,742     0.26      

Forfeited

   (2,719,931     17.86      
                        

Outstanding at June 30, 2009

   5,635,227        5.91    3.39      4,734
                        

Exercisable and expected to vest at June 30, 2009

   4,099,332      $ 5.91    2.27    $ 499
                        

These options expire at various dates from September 15, 2009 to March 9, 2014.

 

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A summary of U.S. dollar stock option transactions is as follows:

 

     No. of
optioned
shares
    Weighted average
exercise price

(in U.S.$)
   Weighted average
remaining
contractual

term (years)
   Aggregate
intrinsic
value
(in U.S.$)

Outstanding at December 31, 2007

   1,051,218      $ 9.39    3.73    $ —  

Forfeited

   (240,000     11.35      
                        

Outstanding at March 31, 2008

   811,218        8.81    3.62      —  
                        

Exercisable and expected to vest at March 31, 2008

   272,315        10.62    2.71      —  
                        

Forfeited

   (50,094     8.36      
                        

Outstanding at June 30, 2008

   761,124        8.84    3.37      —  
                        

Exercisable and expected to vest at June 30, 2008

   314,860      $ 10.40    2.46    $ —  
                        

 

     No. of
optioned
shares
    Weighted average
exercise price

(in U.S.$)
   Weighted average
remaining
contractual

term (years)
   Aggregate
intrinsic
value (in
U.S.$)

Outstanding at December 31, 2008

   1,790,968      $ 3.19    4.19    $ 64

Granted

   1,228,500        0.27      
                        

Outstanding at March 31, 2009

   3,019,468        2.01    4.35      715
                        

Exercisable and expected to vest at March 31, 2009

   2,147,662        2.01    3.14      38
                        

Granted

   15,000        2.06      

Forfeited

   (172,383     7.56      
                        

Outstanding at June 30, 2009

   2,862,085        1.67    4.16      3,355
                        

Exercisable and expected to vest at June 30, 2009

   1,877,814      $ 1.67    2.89    $ 369
                        

These options expire at various dates from June 9, 2010 to March 9, 2014.

American Medical Instruments Holdings, Inc. (“AMI”)

On March 9, 2006, AMI granted 304 stock options under AMI’s 2003 Stock Option Plan (the “AMI Stock Option Plan”), each of which is exercisable for approximately 3,852 of our common shares upon exercise. All outstanding options and warrants granted prior to the March 9, 2006 grant were settled and cancelled upon the acquisition of AMI. No further options to acquire common shares can be issued pursuant to the AMI Stock Option Plan. Approximately 1,171,092 of our common shares were reserved in March 2006 to accommodate future exercises of the AMI options.

 

     No. of
optioned
shares
    Weighted average
exercise price

(in U.S.$)
   Weighted average
remaining
contractual

term (years)
   Aggregate
intrinsic
value

(in U.S.$)

Outstanding at December 31, 2007 and March 31, 2008

   443,012      $ 15.44    7.94    $ —  
                        

Exercisable at March 31, 2008

   55,378        15.44    7.94      —  
                        

Forfeited

   (31,781     15.44      
                        

Outstanding at June 30, 2008

   411,231        15.44    7.69      —  
                        

Exercisable and expected to vest June 30, 2008

   53,938      $ 15.44    7.69    $ —  
                        

 

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Table of Contents
     No. of
optioned
shares
    Weighted average
exercise price

(in U.S.$)
   Weighted average
remaining
contractual

term (years)
   Aggregate
intrinsic
value
(in U.S.$)

Outstanding at December 31, 2008

   363,077      $ 15.44    7.19    $ —  

Forfeited

   (14,927     15.44      
                        

Outstanding at March 31, 2009

   348,150        15.44    6.94      —  
                        

Exercisable and expected to vest at March 31, 2009

   297,459        15.44    6.94      —  
                        

Forfeited

   (30,335     15.44      
                        

Outstanding at June 30, 2009

   317,815        15.44    6.69      —  
                        

Exercisable and expected to vest at June 30, 2009

   271,541      $ 15.44    6.69    $ —  
                        

These options expire on March 8, 2016.

(b) Stock-based compensation expense

We recorded stock-based compensation expense of $0.4 million and $0.8 million respectively for the three and six months ended June 30, 2009 ($0.6 million and $1.4 million, respectively for the three and six months ended June 30, 2008) relating to awards granted under our stock option plan, modified or settled subsequent to October 1, 2002. The estimated fair value of the stock options granted is amortized to expense on a straight-line basis over the vesting period and was estimated on the date of the grant using the Black-Scholes option pricing model with the following weighted average assumptions for grants for the three and six months ended June 30, 2009:

 

     Three months ended
June 30, 2009
   Six months ended
June 30, 2009

Dividend Yield

   Nil    Nil

Expected Volatility

   1.243 – 1.281    1.105 – 1.281

Weighted Average Volatility

   1.258    1.185

Risk-free Interest Rate

   2.00% – 2.07%    1.46% – 2.07%

Expected Term (Years)

   3    3

The weighted average fair value of stock options granted in the three and six months ended June 30, 2009 are presented below:

 

     Three months ended
June 30, 2009
   Six months ended
June 30, 2009

CDN$ options

   $ 1.71    $ 0.32

U.S.$ options

   $ 1.50    $ 0.19

There were no stock options granted in the three and six months ended June 30, 2008.

 

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Table of Contents

A summary of the status of nonvested options as of June 30, 2009 and changes during the three and six months ended June 30, 2009, is presented below:

 

Nonvested CDN$ options

   No. of
optioned
shares
    Weighted average
grant-date

fair value
(in CDN$)

Nonvested at December 31, 2008

   1,968,003      $ 1.24

Vested

   (182,833     2.11

Granted

   1,434,000        0.26
            

Nonvested at March 31, 2009

   3,219,170        0.68
            

Vested

   (54,931     1.99

Forfeited

   (267,030     10.70

Granted

   10,000        1.71
            

Nonvested at June 30, 2009

   2,907,209      $ 0.62
            

Nonvested U.S. $ options

   No. of
optioned
shares
    Weighted average
grant-date

fair value
(in U.S.$)

Nonvested at December 31, 2008

   1,420,490      $ 0.60

Vested

   (115,184     0.93

Granted

   1,228,500        0.18
            

Nonvested at March 31, 2009

   2,533,806        0.31
            

Vested

   (107,185     0.90

Forfeited

   (172,383     5.22

Granted

   15,000        1.50
            

Nonvested at June 30, 2009

   2,269,238      $ 0.37
            

Nonvested AMI options

   No. of
optioned
shares
    Weighted average
grant-date

fair value
(in U.S.$)

Nonvested at December 31, 2008

   313,478      $ 6.51

Vested

   (86,675     6.51

Forfeited

   (10,112     6.51
            

Nonvested at March 31, 2009

   216,691        6.51
            

Forfeited

   (28,890     6.51
            

Nonvested at June 30, 2009

   187,801      $ 6.51
            

As of June 30, 2009, there was $1.8 million of total unrecognized compensation cost related to nonvested stock options granted under the 2006 Plan. These costs are expected to be recognized over a weighted average of 2.2 years.

As of June 30, 2009, there was $0.9 million of total unrecognized compensation cost related to the nonvested AMI stock options granted under the AMI Stock Option Plan. These costs are expected to be recognized over 2.7 years on a straight-line basis as a charge to income. The total fair value of options vested during the three and six months ended June 30, 2009 was $nil and $564,000, respectively ($nil and $360,000 respectively for the three and six months ended June 30, 2008).

During the three and six months ended June 30, 2009 and 2008, the following activity occurred:

 

     Three months ended
June 30,
   Six months ended
June 30,

(in thousands)

   2009    2008    2009    2008

Total intrinsic value of stock options exercised

           

CDN dollar options

   $ 7    $ n/a    $ 7    $ 33

U.S. dollar options

     n/a      n/a      n/a      n/a

Total fair value of stock awards vested

   $ 327    $ 499    $ 1,178    $ 1,569

There was no cash received from stock option exercises for the three and six months ended June 30, 2009 ($nil and $121,000 respectively for the three and six months ended June 30, 2008).

 

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14. COMMITMENTS AND CONTINGENCIES

(a) Commitments

We have entered into research and development collaboration agreements that involve joint research efforts. Certain collaboration costs and any eventual profits will be shared as per terms provided for in the agreements. We may also be required to make milestone, royalty, and / or other research and development funding payments under research and development collaboration and other agreements with third parties. These payments are contingent upon the achievement of specific development, regulatory and/or commercial milestones. We accrue for these payments when it is probable that a liability has been incurred and the amount can be reasonably estimated. We do not accrue for these payments if the outcome of achieving these milestones is not determinable. Our significant contingent milestone, royalty and other research and development commitments are as follows:

Quill Medical, Inc. (“Quill”)

In connection with the acquisition of Quill in June 2006, we may be required to make additional contingent payments of up to $150 million upon the achievement of certain revenue growth and a development milestone. These payments are primarily contingent upon the achievement of significant incremental revenue growth over a five-year period from July 1, 2006, subject to certain conditions.

National Institutes of Health (“NIH”)

In November 1997, we entered into an exclusive license agreement with the Public Health Service of the United States, through the NIH, whereby we were granted an exclusive, worldwide license to certain technologies of the NIH relating to the use of paclitaxel. Pursuant to this license agreement, we agreed to pay NIH milestone payments upon achievement of certain clinical and commercial development milestones and pay royalties on net TAXUS sales by BSC and ZILVER sales by Cook Medical Inc. At June 30, 2009, we have accrued royalty fees of $8.0 million payable to NIH under this agreement related to royalties on sales in the third and fourth calendar quarters of 2008 and the first calendar quarter of 2009.

Biopsy Sciences LLC (“Biopsy Sciences”)

In connection with the acquisition of certain assets from Biopsy Sciences in January 2007, we may be required to make certain contingent payments of up to $2.7 million upon the achievement of certain clinical and regulatory milestones and up to $10.7 million for achieving certain commercialization milestones. As of June 30, 2009, we have paid $0.7 million towards the successful completion of the U.S. clinical trial enrollment for the Bio-Seal lung biopsy track plug.

Rex Medical LP (“Rex Medical”)

In March 2008, we entered into an agreement with Rex Medical to manufacture and distribute the Option TM Inferior Vena Cava (“IVC”) Filter. For the quarter ended June 30, 2008, we made a payment of $2.5 million to Rex Medical to obtain the marketing rights for the Option IVC Filter. We recorded this payment as an in-process and research development cost. For the quarter ended June 30, 2009, we made a milestone payment of $2.5 million upon achievement of the FDA 510(k) clearance. We have capitalized this payment as an intangible asset. Under terms of this agreement, we may be required to make further contingent payments of up to $5.0 million upon achievement of certain regulatory and commercialization milestones. In addition, we have committed to making escalating royalty payments of 30% to 47.5% based on annual net sales of these products.

 

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Haemacure Corporation (“Haemacure”)

In June 2009, we entered into license, distribution, development and supply agreements for fibrin and thrombin technologies with Haemacure. The collaboration provides us with access to technology for certain of our surgical product candidates which are currently in preclinical development. As part of this collaboration, we have agreed to provide to Haemacure a senior secured bridge financing facility. The senior bridge loan will provide $2.5 million to Haemacure in multiple draw-downs throughout 2009. The loan will be senior to all of Haemacure’s existing and future indebtedness, subject to certain exceptions, will bear interest at an annual rate of 10%, compounded quarterly, and will have a term of two years. We may, at our sole discretion, during a period of two years, advance up to an additional $1 million to Haemacure from time to time, in multiple draw-downs, for a total loan amount of $3.5 million. The senior secured bridge loan also has certain equity conversion features and rights to board representation upon conversion. As of June 30, 2009, $1.2 million of the secured bridge financing facility has been drawn upon by Haemacure and a further $0.6 million of the loan, which had been accrued at June 30, 2009, was drawn upon subsequent to June 30, 2009. Of the total of $1.8 million paid and accrued, $1.2 million has been classified as other assets and $0.6 million has been classified as prepaid expenses and other current assets.

(b) Contingencies

 

  i) From time to time, we may be subject to claims and legal proceedings brought against us in the normal course of business. Such matters are subject to many uncertainties. We believe that adequate provisions have been made in the accounts where required. However, we are not able to determine the outcome or estimate potential losses of the pending legal proceedings listed below, or other legal proceedings, to which we may become subject in the normal course of business or estimate the amount or range of any possible loss we might incur if it does not prevail in the final, non-appealable determinations of such matters. We cannot provide assurance that the legal proceedings listed here, or other legal proceedings not listed here, will not have a material adverse impact on our financial condition or results of operations.

 

  ii) BSC, a licensee, is often involved in legal proceedings (to which we are not a party) concerning challenges to its stent business. If a party opposing BSC is successful, and if a court were to issue an injunction against BSC, royalty revenue would likely be significantly reduced. The ultimate outcome of any such proceedings is uncertain at this time.

 

  iii) On April 4, 2005, together with BSC, we commenced a legal action in the Netherlands against Sahajanand Medical Technologies Pvt. Ltd. (“SMT”) for patent infringement. On May 3, 2006, the Dutch trial court ruled in our favor, finding that our EP (NL) 0 706 376 patent was valid, and that SMT’s Infinnium™ stent infringed the patent. On March 13, 2008, a Dutch Court of Appeal held a hearing to review the correctness of the trial court’s decision. The Court of Appeal released their judgment on January 27, 2009, ruling against SMT (finding our patent novel, inventive, and sufficiently disclosed). The Court of Appeal however requested amendment of claim 12 before rendering their decision on infringement. We have filed a response to the Court’s decision, and have additionally filed a further Writ against SMT seeking to prevent SMT from, among other things, use of their CE mark for SMT’s Infinnium™ stent. A date for the court’s decision on infringement has not yet been set. Any decision of the Court of Appeal is appealable to the Supreme Court of the Netherlands.

 

  iv) On March 23, 2006, RoundTable Healthcare Partners, LP as Seller Representative, we as Buyer, and LaSalle Bank (“LaSalle”) as Escrow Agent, executed an Escrow Agreement under which we deposited $20 million with LaSalle. On April 4, 2007, LaSalle received an Escrow Claim Notice issued by us, which directed LaSalle to remit the $20 million to us as Buyer. On or about April 16, 2007, LaSalle received from RoundTable a Notice of Objection to our Escrow Claim Notice. On July 3, 2007, LaSalle filed an action in the Circuit Court of Cook County, Illinois, asking the court to resolve this dispute. After various hearings and discussions, we executed a Joint Letter of Direction allowing the release of $6.5 million to RoundTable, thereby leaving the amount in dispute being approximately $13.5 million. On March 21, 2008, this action was moved to the U.S. District Court Southern District of New York. We are now in the discovery phase of this litigation. On March 20, 2009, Roundtable filed a motion for partial summary judgment and a hearing was held on April 16, 2009. On April 8, 2009, we filed a motion to dismiss certain of the claims in the lawsuit as not yet ripe for resolution. A hearing on our motion was held on April 30, 2009. We do not know when a decision will be issued by the court on either motion. The escrow amounts have been included in the acquisition cost related to the AMI acquisition and amounts held in escrow are not reflected as financial assets in the consolidated financial statements.

 

  v) In July 2004, Dr. Gregory Baran initiated legal action, alleging infringement by Medical Device Technologies Inc. (“MDT”) of two U.S. patents owned by Dr. Baran. These patents allegedly cover MDT’s BioPince™ automated biopsy device. On September 25, 2007, the judge issued her decision pursuant to the Markman hearing (patent claim interpretation) of December 2005. We have submitted a Motion for Summary Judgment to the court based upon the Markman decision. No hearing date has yet been set by the court.

 

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  vi) At the European Patent Office (“EPO”), various patents either owned or licensed by or to us are in opposition proceedings including the following:

 

   

In EP0784490, an oral hearing has been scheduled for October 1, 2009.

 

   

In EP0809515 (which is licensed from (and to) BSC), the EPO held an oral hearing on January 30, 2008 and thereafter revoked this patent. An appeal was filed on April 22, 2008. The parties have been summoned to attend an oral hearing on the appeal at the EPO on June 19, 2009. On February 26, 2009, BSC submitted a request to withdraw from the oral hearing. On June 25, 2009 the EPO issued a notice stating that the decision under appeal was set aside and the patent would be remitted to the patent examiner for further prosecution.

 

   

In EP0830110 (which is licensed from Edwards LifeSciences Corporation) an amended form of this patent was found valid after an oral hearing on September 28, 2006; however, the opponent appealed the decision on December 21, 2006. An oral hearing has been scheduled for September 9, 2009.

 

   

In EP0876166 the EPO held an oral hearing on September 24, 2008, and thereafter revoked this patent. Angiotech filed an appeal on January 19, 2009, and then filed a request to withdraw the appeal on March 10, 2009.

 

   

In EP0975340 (which is licensed from (and to) BSC), an oral hearing was held on December 4, 2008. The EPO issued an Interlocutory Decision on December 23, 2008 stating the patent was found to have met the requirements of the convention. The opponent has appealed this decision. The opponent withdrew their appeal on June 23, 2009, and requested that the patent be maintained in amended form.

 

   

In EP1118325 (which is licensed from the NIH), an oral hearing was held on April 7, 2009, and the patent was upheld. The decision is appealable.

 

   

In EP1155689, briefs are being exchanged.

 

   

In EP1407786 (which is licensed from (and to) BSC), the patent was revoked in a decision from the EPO on December 9, 2008. An appeal was filed on January 30, 2009. An appeal was also filed on behalf of the opponent on April 8, 2009.

 

   

In EP1429664, an oral hearing had been scheduled for May 27, 2009; however, the oral hearing was canceled by the EPO on May 14, 2009. The proceedings will continue in writing.

 

   

In EP1159974, briefs are being exchanged.

 

   

In EP1159975, a Notice of Opposition was filed on June 5, 2009. The EPO has not yet set a date for Angiotech’s response.

 

   

In EP0991359, Angiotech’s response to the opposition was due prior to the extended deadline of May 15, 2009 but Angiotech did not file a response. A notice of failure to respond to the opposition was issued by the EPO on July 7, 2009. Angiotech’s response to this notice is due September 7, 2009.

 

   

In EP0876165, the EPO revoked the patent as an outcome of an oral hearing held on June 24, 2009. An appeal may be filed up to August 24, 2009.

 

  vii) On July 7, 2008, we entered into a note purchase agreement (the “Note Purchase Agreement”) with Ares Management (“Ares”) and New Leaf Venture Partners (“New Leaf”) under which Ares and New Leaf agreed to purchase between $200 and $300 million, at our option, of convertible notes to be issued by the newly formed subsidiary. In connection with our entry into the Note Purchase Agreement, we commenced a tender offer for our Floating Rate Notes and Subordinated Notes for an aggregate purchase price of $165 million including accrued and unpaid interest and certain premiums. On September 22, 2008, we announced that we would be unable to satisfy the conditions to closing in the Note Purchase Agreement, and on September 23, 2008, we announced the termination of the tender offer and the transaction was abandoned. Ares and New Leaf subsequently terminated the Note Purchase Agreement on November 19, 2008. The Note Purchase Agreement provided for a non-refundable fee, subject to certain conditions, of $3 million to Ares and New Leaf plus reimbursement of up to an additional $3 million for Ares’ and New Leaf’s transaction-related expenses. The Note Purchase Agreement also provided that if we were to enter into an agreement related to an Alternate Transaction, as defined in the Note Purchase Agreement, within 12 months of termination of the Note Purchase Agreement, we would have been required to pay Ares and New Leaf a non-refundable fee of $10 million plus reimburse Ares and New Leaf for transaction-related expenses of up to an additional $4 million (subject to certain conditions) upon our agreement to such Alternative Transaction. On June 17, 2009 we entered into a Settlement Agreement and Mutual Release (the “Settlement Agreement”) with Ares and New Leaf that fully resolved any existing and potential claims under the Note Purchase Agreement and we have made all payments specified in the Settlement Agreement. In connection with certain types of alternative transactions to the transaction described above in the Note Purchase Agreement, we may also be required under the terms of agreements with certain advisers to pay fees to such advisors, whether or not such advisors participate in such alternative transactions. Our obligations to such advisors end in May 2010.

 

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15. SEGMENTED INFORMATION

We operate in two reportable segments: (i) Pharmaceutical Technologies and (ii) Medical Products. We report segmented information to the gross margin level. All other income and expenses are not allocated to segments as they are not considered in evaluating the segment’s operating performance.

The Pharmaceuticals Technologies segment includes royalty revenue generated from out-licensing technology related to the drug-eluting stent and other technologies.

The Medical Products segment includes revenues and gross margins of single use, specialty medical devices including suture needles, biopsy needles / devices, micro surgical ophthalmic knives, drainage catheters, self-anchoring sutures, other specialty devices, biomaterials and other technologies.

The following tables represent reportable segment information for the three and six months ended June 30, 2009 and 2008:

 

     Three months ended
June 30,
    Six months ended
June 30,
 
     2009     2008     2009     2008  

Revenue

        

Pharmaceutical Technologies

   $ 17,394      $ 25,589      $ 59,557      $ 54,571   

Medical Products

     47,179        50,533        93,316        98,259   
                                

Total revenue

     64,573        76,122        152,873        152,830   
                                

Licence and royalty fees – Pharmaceutical Technologies

     2,568        3,661        5,474        8,032   

Cost of products sold – Medical Products

     25,682        26,809        49,648        52,658   
                                

Gross margin

        

Pharmaceutical Technologies

     14,826        21,928        54,083        46,539   

Medical Products

     21,497        23,724        43,668        45,601   
                                

Total gross margin

     36,323        45,652        97,751        92,140   
                                

Research and development

     6,833        18,584        12,930        34,889   

Selling, general and administration

     21,606        25,813        41,178        53,654   

Depreciation and amortization

     8,296        8,539        16,560        17,017   

In-process research and development

     —          —          —          2,500   
                                

Operating (loss) income

     (412     (7,284     27,083        (15,920

Other expenses

     (11,682     (20,775     (21,009     (31,716
                                

(Loss) income before income taxes

   $ (12,094   $ (28,059   $ 6,074      $ (47,636
                                

During the three months ended June 30, 2009, revenue from one licensee represented approximately 25% of total revenue, and during the six months ended June 30, 2009, revenue from two licensees represented approximately 37% of total revenue. During the three and six months ended June 30, 2008, revenue from one licensee represented approximately 31% and 33% of total revenue, respectively.

We allocate our assets into two reportable segments; however, as noted above, depreciation, income taxes and other expenses and income are not allocated to segment operating units. The following table represents total assets for each reportable segment at June 30, 2009 and December 31, 2008:

 

     June 30,
2009
   December 31,
2008

Total assets

     

Pharmaceutical Technologies

   $ 83,117    $ 67,506

Medical Products

     299,203      317,691
             

Total assets

   $ 382,320    $ 385,197
             

 

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The following table represents capital expenditures for each reportable segment at June 30, 2009 and 2008:

 

     Three months ended
June 30
   Six months ended June 30
           2009                2008                2009                2008      

Capital expenditures

           

Pharmaceutical Technologies

   $ 202    $ 225    $ 241    $ 760

Medical Products

     744      2,163      1,498      5,687
                           

Total capital expenditures

   $ 946    $ 2,388    $ 1,739    $ 6,447
                           

 

16. RESTRUCTURING CHARGES

During the three and six months ended June 30, 2009, we recorded charges of $0.2 million and $0.5 million, respectively, related to various relocation activities at our Puerto Rico location associated with capacity rationalization and consolidation in the Medical Products segment. For the three and six months ended June 30, 2008, we recorded charges of $0.9 million and $1.6 million, respectively, related to various relocation activities at our Syracuse and Puerto Rico locations, and $0.5 million and $1.5 million, respectively, related to employee severance benefits at our Syracuse plant location. The charges related to relocation activities are being recorded as incurred.

As at June 30, 2009, a liability of $1.4 million (December 31, 2008 – $4.1 million) was accrued related to the severance cost associated with our Syracuse location and we have terminated or transferred all of the employees from our Syracuse location.

The expenses recorded in accordance with SFAS 146, Accounting for Costs Associated with Exit or Disposal Activities require us to make significant estimates and assumptions. These estimates and assumptions will be evaluated and adjusted as appropriate on at least a quarterly basis for changes in circumstances. It is possible that such estimates could change in the future resulting in additional adjustments, and the effect of any such adjustments could be material.

Changes in the accrued liability for restructuring charges are as follows:

 

     Severance Benefits  

Balance, December 31, 2007

   $ 3,227   

Severances charged

     1,664   

Accretion expense

     156   

Severances paid

     (973
        

Balance, December 31, 2008

   $ 4,074   

Severances paid

     (2,649
        

Balance, June 30, 2009

   $ 1,425   
        

 

17. NET LOSS PER SHARE

Net loss per share was calculated as follows:

 

     Three months ended
June 30,
    Six months ended
June 30,
 
           2009                 2008                 2009                2008        

Numerator:

         

Net (loss) income

   $ (11,877   $ (26,071   $ 567    $ (41,834
                               

Denominator:

         

Basic and diluted weighted average common shares outstanding (1)

     85,122        85,122        85,122      85,114   
                               

Basic and diluted net (loss) income per common share:

   $ (0.14   $ (0.31   $ 0.01    $ (0.49
                               

 

  (1)

There is no dilutive effect on basic weighted average common shares outstanding for the three months ended June 30, 2009 and 2008 and the six months ended June 30, 2008 as we were in a loss position for those periods. There is no diluted effect on basic weighted average common shares outstanding for the six months ended June 30, 2009 as the impact of in-the-money stock options was negligible.

 

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18. CHANGE IN NON-CASH WORKING CAPITAL ITEMS RELATING TO OPERATIONS AND SUPPLEMENTAL CASH FLOW INFORMATION

The change in non-cash working capital items relating to operations was as follows:

 

     Three months ended
June 30,
    Six months ended
June 30,
 
         2009                 2008               22009                 2008        

Accounts receivable

   $ 467      $ (1,169   $ (2,532   $ (5,545

Inventories

     1,089        (2,910     58        (2,137

Prepaid expenses and other assets

     (595     1,011        6,357        2,541   

Accounts payable and accrued liabilities

     (1,706     4,224        (1,514     3,315   

Income taxes payable

     769        (3,648     (291     (3,473

Interest payable on long term debt

     (4,983     4,675        (406     (742
                                
   $ (4,959   $ 2,183      $ 1,672      $ (6,041
                                

Supplemental disclosure:

 

     Three months ended
June 30,
   Six months ended
June 30,
           2009                2008                2009                2008      

Income taxes paid

   $  1,690      $      629      $  3,100      $  1,560  

 

19. CONDENSED CONSOLIDATING GUARANTOR FINANCIAL INFORMATION

The following presents the condensed consolidating guarantor financial information as of June 30, 2009 and December 31, 2008, and for the three and six months ended June 30, 2009 and 2008 for our direct and indirect subsidiaries that serve as guarantors of the Senior Subordinated Notes and the Senior Floating Rate Notes, and for our subsidiaries that do not serve as guarantors. Non-guarantor subsidiaries include the Swiss subsidiaries and a Canadian Trust that cannot guarantee our debt. All of our subsidiaries are 100% owned, and all guarantees are full and unconditional, joint and several.

 

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Condensed Consolidating Balance Sheet

As at June 30, 2009

USD (in ‘000s)

 

    Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantors
Subsidiaries
    Non Guarantors
Subsidiaries
    Consolidating
Adjustments
    Consolidated
Total
 

ASSETS

         

Current assets

         

Cash and cash equivalents

  $ 32,010      $ 7,730      $ 10,918      $ —        $ 50,658   

Short term investments

    1,657        —          —          —          1,657   

Accounts receivable

    392,302        48,267        276,715        (688,878     28,406   

Inventories

    —          31,133        8,883        (1,255     38,761   

Deferred income taxes, current portion

    —          3,520        —          —          3,520   

Prepaid expenses and other current assets

    1,511        2,634        330        —          4,475   
                                       

Total Current Assets

    427,480        93,283        296,846        (690,133     127,476   
                                       

Long term investments

    825        —          736        —          1,561   

Investment in subsidiaries

    50,699        293,123        —          (343,822     —     

Assets held for sale

    5,363        3,100        —          —          8,463   

Property, plant and equipment

    8,397        31,173        7,723        —          47,293   

Intangible assets

    13,834        149,009        20,387        —          183,230   

Goodwill

    —          —          —          —          —     

Deferred financing costs

    10,244        2,154        —          —          12,398   

Other assets

    1,281        501        117        —          1,899   
                                       

Total Assets

  $ 518,123      $ 572,343      $ 325,809      $ (1,033,955   $ 382,320   
                                       

LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY

  

Current liabilities

         

Accounts payable and accrued liabilities

  $ 247,877      $ 417,789      $ 67,852      $ (688,902   $ 44,616   

Income taxes payable

    (1,740     7,100        2,395        —          7,755   

Interest payable on long-term debt

    6,109        —          —          —          6,109   

Deferred revenue, current portion

    —          —          210        —          210   
                                       

Total Current Liabilities

    252,246        424,889        70,457        (688,902     58,690   
                                       

Deferred revenue

    —          —          895        —          895   

Deferred leasehold inducement

    2,640        410        —          —          3,050   

Deferred income taxes

    (1,683     39,013        533        —          37,863   

Other tax liabilities

    1,915        726        321        —          2,962   

Long-term debt

    575,000        —          —          —          575,000   

Other liabilities

    —          92        812        —          904   
                                       

Total Non-current Liabilities

    577,872        40,241        2,561        —          620,674   
                                       

Shareholders’ (Deficit) Equity

         

Share capital

    472,740        917,189        262,209        (1,179,398     472,740   

Additional paid in capital

    32,915        91,406        18,058        (109,464     32,915   

Accumulated deficit

    (838,499     (901,119     (45,540     942,053        (843,105

Accumulated other comprehensive income

    20,849        (263     18,064        1,756        40,406   
                                       

Total Shareholders’ (Deficit) Equity

    (311,995     107,213        252,791        (345,053     (297,043
                                       

Total Liabilities and Shareholders’ (Deficit) Equity

  $ 518,123      $ 572,343      $ 325,809      $ (1,033,955   $ 382,320   
                                       

 

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Condensed Consolidating Balance Sheet

As at December 31, 2008

USD (in ‘000s)

 

    Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantors
Subsidiaries
    Non Guarantors
Subsidiaries
    Consolidating
Adjustments
    Consolidated
Total
 

ASSETS

         

Current assets

         

Cash and cash equivalents

  $ 10,180      $ 6,572      $ 22,200      $ —        $ 38,952   

Short term investments

    848        —          —          —          848   

Accounts receivable

    397,846        73,663        258,349        (704,334     25,524   

Inventories

    —          31,939        7,824        (1,169     38,594   

Deferred income taxes, current portion

    —          3,820        —          —          3,820   

Prepaid expenses and other current assets

    1,674        3,074        486        —          5,234   
                                       

Total Current Assets

    410,548        119,068        288,859        (705,503     112,972   
                                       

Long term investments

    825        —          736        —          1,561   

Investment in subsidiaries

    60,204        292,438        —          (352,642     —     

Assets held for sale

    5,322        3,100        —            8,422   

Property, plant and equipment

    9,194        30,326        9,588        —          49,108   

Intangible assets

    15,112        158,097        22,268        —          195,477   

Goodwill

    —          —          —          —          —     

Deferred financing costs

    11,363        —          —          —          11,363   

Deferred income taxes

    —          —          —          —          —     

Other assets

    271        5,911        112        —          6,294   
                                       

Total Assets

  $ 512,839      $ 608,940      $ 321,563      $ (1,058,145   $ 385,197   
                                       

LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY

  

Current liabilities

         

Accounts payable and accrued liabilities

  $ 232,391      $ 418,529      $ 100,057      $ (704,357   $ 46,620   

Income taxes payable

    (1,260     6,974        2,357        —          8,071   

Interest payable on long-term debt

    6,514        —          —          —          6,514   

Deferred revenue, current portion

    —          —          210        —          210   
                                       

Total Current Liabilities

    237,645        425,503        102,624        (704,357     61,415   
                                       

Deferred revenue

    —          —          999        —          999   

Deferred leasehold inducement

    2,768        12        —          —          2,780   

Deferred income taxes

    (1,959     42,010        526        —          40,577   

Other tax liabilities

    2,292        585        268        —          3,145   

Long-term debt

    575,000        —          —          —          575,000   

Other liabilities

    —          272        882        —          1,154   
                                       

Total Non-current Liabilities

    578,101        42,879        2,675        —          623,655   
                                       

Shareholders’ (Deficit) Equity

         

Share capital

    472,739        917,189        262,209        (1,179,398     472,739   

Additional paid in capital

    32,108        91,405        18,059        (109,465     32,107   

Accumulated deficit

    (827,794     (866,180     (83,019     933,319        (843,674

Accumulated other comprehensive income

    20,040        (1,856     19,014        1,756        38,954   
                                       

Total Shareholders’ (Deficit) Equity

    (302,907     140,558        216,264        (353,788     (299,874
                                       

Total Liabilities and Shareholders’ (Deficit) Equity

  $ 512,839      $ 608,940      $ 321,563      $ (1,058,145   $ 385,197   
                                       

 

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Table of Contents

Condensed Consolidating Statement of Operations

Three months ended June 30, 2009

USD (in ‘000s)

 

     Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantors
Subsidiaries
    Non Guarantors
Subsidiaries
    Consolidating
Adjustments
    Consolidated
Total
 

REVENUE

          

Royalty revenue

   $ 16,085      $ 911      $ —        $ —        $ 16,996   

Product sales, net

     —          37,098        15,090        (5,009     47,179   

License fees

     —          39        359        —          398   
                                        
     16,085        38,048        15,449        (5,009     64,573   
                                        

EXPENSES

          

License and royalty fees

     2,558        —          10        —          2,568   

Cost of products sold

     16        21,347        9,562        (5,243     25,682   

Research & development

     4,495        2,247        91        —          6,833   

Intercompany R&D charges

     496        (496     —          —          —     

Selling, general and administration

     4,753        13,434        3,419        —          21,606   

Depreciation and amortization

     1,162        4,166        2,968        —          8,296   
                                        
     13,480        40,698        16,050        (5,243     64,985   
                                        

Operating income (loss)

     2,605        (2,650     (601     234        (412
                                        

Other income (expense)

          

Foreign exchange gain (loss)

     (19,279     81        17,749        8        (1,441

Investment and other income

     18        (614     (4     —          (600

Interest expense on long-term debt

     (9,343     (143     (155     —          (9,641

Management fees

     (47     47        —          —          —     

Dividend income

     —          1,000        —          (1,000     —     
                                        

Total other expenses

     (28,651     371        17,590        (992     (11,682
                                        

Income (loss) before income taxes

     (26,046     (2,279     16,990        (758     (12,094

Income tax (recovery) expense

     (363     (1,716     1,862        —          (217
                                        

Income (loss) from operations

     (25,683     (562     15,127        (758     (11,877

Equity in subsidiaries

     17,184        19,825        —          (37,009     —     
                                        

Net income (loss)

   $ (8,499   $ 19,263      $ 15,127      $ (37,768   $ (11,877
                                        

 

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Table of Contents

Condensed Consolidating Statement of Operations

Six months ended June 30, 2009

USD (in '000s)

 

     Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantors
Subsidiaries
    Non Guarantors
Subsidiaries
    Consolidating
Adjustments
    Consolidated
Total
 

REVENUE

          

Royalty revenue

   $ 30,989      $ 1,980      $ 1,138      $ —        $ 34,107   

Product sales, net

     —          73,904        29,254        (9,841     93,316   

License fees

     —          67        25,383        —          25,450   
                                        
     30,989        75,951        55,775        (9,841     152,873   
                                        

EXPENSES

          

License and royalty fees

     5,463        —          10        —          5,473   

Cost of products sold

     71        40,454        18,877        (9,754     49,648   

Research & development

     8,509        4,263        158        —          12,930   

Intercompany R&D

     496        (496     —          —          —     

Selling, general and administration

     8,724        26,612        5,842        —          41,178   

Depreciation and amortization

     2,356        8,284        5,921        —          16,561   
                                        
     25,619        79,117        30,808        (9,754     125,790   
                                        

Operating income (loss)

     5,370        (3,166     24,967        (87     27,083   
                                        

Other income (expense)

          

Foreign exchange gain

     (12,488     (1,945     13,727        (3     (709

Investment and other

     (5     (617     6        —          (616

Interest expense on long-

     (19,328     125        (481     —          (19,684

Management fees

     (47     47        —          —          —     

Dividend income

     —          3,000        —          (3,000     —     
                                        

Total other expenses

     (31,868     610        13,252        (3,003     (21,009
                                        

(Loss) income before income taxes

     (26,498     (2,556     38,219        (3,090     6,074   

Income tax (recovery) expense

     (368     2,527        3,348        —          5,507   
                                        

(Loss) income from operations

     (26,130     (5,083     34,871        (3,090     567   

Equity in subsidiaries

     34,033        14,670        —          (48,703     —     
                                        

Net income (loss)

   $ 7,903      $ 9,587      $ 34,871      $ (51,793   $ 567   
                                        

 

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Condensed Consolidating Statement of Operations

Three months Ended June 30, 2008

USD (in ‘000s)

 

     Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Consolidating
Adjustments
    Consolidated
Totals
 

REVENUE

          

Royalty revenue

   $ 23,578      $ 827      $ 1,131      $ —        $ 25,536   

Product sales, net

     —          34,255        18,427        (2,149     50,533   

License fees

     —          (24     77        —          53   
                                        
     23,578        35,058        19,635        (2,149     76,122   
                                        

EXPENSES

          

License and royalty fees

     3,656        5        —          —          3,661   

Cost of products sold

     —          16,297        12,116        (1,604     26,809   

Research and development

     11,924        6,296        364        —          18,584   

Intercompany R&D charges

     1,983        (2,407     294        130        —     

Selling, general and administration

     6,349        15,431        4,033        —          25,813   

Depreciation and amortization

     1,221        6,013        1,169        136        8,539   
                                        
     25,133        41,635        17,976        (1,338     83,406   
                                        

Operating (loss) income

     (1,555     (6,577     1,659        (811     (7,284
                                        

Other income (expenses) :

          

Foreign exchange gain (loss)

     204        (1,065     958        43        140   

Investment and other income

     524        9        156        (3     686   

Interest income (expense)

     (10,941     (2,743     2,740        3        (10,941

Write-down/loss on redemption of investments

     (10,660     —          —          —          (10,660

Management fees

     (915     834        (49     130        —     
                                        

Total other income (expenses)

     (21,788     (2,965     3,805        173        (20,775
                                        

(Loss) income from continuing operations before income taxes

     (23,343     (9,542     5,464        (638     (28,059

Income tax expense (recovery)

     (50     702        (2,640     —          (1,988
                                        

Income (loss) from continuing operations

     (23,293     (10,244     8,104        (638     (26,071
                                        

Equity in subsidiaries

     (1,080     6,801        —          (5,721     —     
                                        

Net (loss) income

   $ (24,373   $ (3,443   $ 8,104      $ (6,359   $ (26,071
                                        

 

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Condensed Consolidating Statement of Operations

Six Months Ended June 30, 2008

USD (in 000’s)

 

     Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Consolidating
Adjustments
    Consolidated
Totals
 

REVENUE

          

Royalty revenue

   $ 50,782      $ 1,351      $ 2,333      $ —        $ 54,466   

Product sales, net

     —          66,140        35,419        (3,300     98,259   

License fees

     —          (45     150        —          105   
                                        
     50,782        67,446        37,902        (3,300     152,830   
                                        

EXPENSES

          

License and royalty fees

     8,024        8        —          —          8,032   

Cost of products sold

     —          32,624        22,220        (2,186     52,658   

Research and development

     21,580        12,657        652        —          34,889   

Intercompany R&D charges

     3,414        (4,358     713        231        —     

Selling, general and administration

     13,448        30,982        9,224        —          53,654   

Depreciation and amortization

     2,382        12,026        2,337        272        17,017   

In-process research and development

     —          2,500        —          —          2,500   
                                        
     48,848        86,439        35,146        (1,683     168,750   
                                        

Operating income (loss)

     1,934        (18,993     2,756        (1,617     (15,920
                                        

Other income (expenses) :

          

Foreign exchange gain (loss)

     151        3,755        (3,337     (6     563   

Investment and other income

     873        77        492        —          1,442   

Interest income (expense)

     (10,822     (20,970     8,730        1        (23,061

Write-down/loss on redemption of investments

     (10,660     —          —          —          (10,660

Dividend income

     20,000        —          —          (20,000     —     

Management fees

     (1,533     1,407        (105     231        —     
                                        

Total other (expenses) income

     (1,991     (15,731     5,780        (19,774     (31,716
                                        

(Loss) income from continuing operations
before income taxes

     (57     (34,724     8,536        (21,391     (47,636

Income tax expense (recovery)

     161        (5,662     (707     406        (5,802
                                        

(Loss) income from continuing operations

     (218     (29,062     9,243        (21,797     (41,834
                                        

Equity in subsidiaries

     (37,705     (3,305     —          41,010        —     
                                        

Net (loss) income

   $ (37,923   $ (32,367   $ 9,243      $ 19,213      $ (41,834
                                        

 

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Condensed Consolidating Statement of Cash Flows

Three months ended June 30, 2009

USD (in ‘000s)

 

    Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantors
Subsidiaries
    Non Guarantors
Subsidiaries
    Consolidating
Adjustments
  Consolidated
Total
 

OPERATING ACTIVITIES:

         

Cash used in operating activities

  $ (25,888   $ (4,691   $ 23,062      $ —     $ (7,517
                                     

INVESTING ACTIVITIES:

         

Purchase of property, plant and equipment

    (201     (715     (30     —       (946

Purchase of intangible assets

    —          (2,500     —          —       (2,500

Loans advanced

    (1,200           (1,200

Other

    12        —          —          —       12   
                                     

Cash used in investing activities

    (1,389     (3,215     (30     —       (4,634
                                     

FINANCING ACTIVITIES:

         

Deferred financing charges and costs

    (1,386     —          —          —       (1,386

Dividends received / (paid)

    —          1,000        (1,000     —       —     

Intercompany notes payable/receivable

    19,362        951        (20,313     —       —     
                                     

Cash provided by (used in) financing activities

    17,976        1,951        (21,313     —       (1,386
                                     

Effect of exchange rate changes on cash and cash equivalents

    —          (17     (311     —       (328

Net (decrease) increase in cash and cash equivalents

    (9,301     (5,972     1,408        —       (13,865

Cash and cash equivalents, beginning of period

    41,311        13,702        9,510        —       64,523   
                                     

Cash and cash equivalents, end of period

  $ 32,010      $ 7,730      $ 10,918      $ —     $ 50,658   
                                     

 

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Condensed Consolidating Statement of Cash Flows

Six months ended June 30, 2009

USD (in ‘000s)

 

    Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantors
Subsidiaries
    Non Guarantors
Subsidiaries
    Consolidating
Adjustments
  Consolidated
Total
 

OPERATING ACTIVITIES:

         

Cash used in operating activities

  $ 11,836      $ 193      $ 7,843      $ —     $ 19,872   
                                     

INVESTING ACTIVITIES:

         

Purchase of property, plant and equipment

    (240     (1,399     (50     —       (1,689

Purchase of intangible assets

    —          (2,500     —          —       (2,500

Loans advanced

    (1,200     —          —          —       (1,200

Other

    12        334        (95     —       251   
                                     

Cash used in investing activities

    (1,428     (3,565     (145     —       (5,138
                                     

FINANCING ACTIVITIES:

         

Deferred financing charges and costs

    (1,366     (1,610     —          —       (2,976

Dividends received / (paid)

    —          3,000        (3,000     —       —     

Intercompany notes payable/receivable

    12,787        3,155        (15,942     —       —     
                                     

Cash provided by (used in) financing activities

    11,421        4,545        (18,942     —       (2,976
                                     

Effect of exchange rate changes on cash and cash equivalents

    —          (15     (38     —       (52

Net (decrease) increase in cash and cash equivalents

    21,829        1,159        (11,282     —       11,706   

Cash and cash equivalents, beginning of period

    10,181        6,571        22,200        —       38,952   
                                     

Cash and cash equivalents, end of period

  $ 32,010      $ 7,730      $ 10,918      $ —     $ 50,658   
                                     

 

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Condensed Consolidating Statement of Cash Flows

Three Months Ended June 30, 2008

USD (in ‘000s)

 

    Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Consolidating
Adjustments
  Consolidated
Totals
 

OPERATING ACTIVITIES:

         

Cash (used in) provided by operating activities

  $ (11,978   $ (2,810   $ 12,801      $ —     $ (1,987
                                     

INVESTING ACTIVITIES:

         

Purchase of property, plant and equipment

    (261     (1,625     (502     —       (2,388

Purchase of intangibles

    —          (1,000     —          —       (1,000

Other assets

    68        215        (133     —       150   
                                     

Cash (used in) provided by investing activities

    (193     (2,410     (635     —       (3,268
                                     

FINANCING ACTIVITIES:

         

Deferred financing costs

    (1,522     —          (14     —       (1,536

Notes receivable / payable

    23,891        (675     (23,216     —       —     
                                     

Cash provided by (used in) financing activities

    22,369        (675     (23,230     —       (1,536
                                     

Effect of exchange rate changes on cash and cash equivalents

    —          (19     (97     —       (116

Net increase (decrease) in cash and cash equivalents

    10,198        (5,914     (11,161     —       (6,877

Cash and cash equivalents, beginning of year

    22,058        9,290        38,444        —       69,792   
                                     

Cash and cash equivalents, end of year

  $ 32,256      $ 3,376      $ 27,283      $ —     $ 62,915   
                                     

 

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Condensed Consolidating Statement of Cash Flows

Six Months Ended June 30, 2008

USD (in ‘000s)

 

    Parent Company
Angiotech
Pharmaceuticals,
Inc.
    Guarantor
Subsidiaries
    Non-Guarantor
Subsidiaries
    Consolidating
Adjustments
    Consolidated
Totals
 

OPERATING ACTIVITIES:

         

Cash (used in) provided by operating activities

  $ (8,102   $ (11,581   $ 21,254      $ (20,000   $ (18,429
                                       

INVESTING ACTIVITIES:

         

Purchase of property, plant and equipment

    (919     (4,003     (863   $ —        $ (5,785

Purchase of intangibles

    —          (1,000     —          —          (1,000

In-process research and development

    (2,500     —          —          —          (2,500

Other assets

    (725     977        52        —          304   
                                       

Cash (used in) provided by investing activities

    (4,144     (4,026     (811     —          (8,981
                                       

FINANCING ACTIVITIES:

         

Deferred financing costs

    (1,607     —          (14     —          (1,621

Dividends paid

    —          —          (20,000     20,000        —     

Notes receivable / payable

    22,198        (1,352     (20,846     —          —     

Proceeds from stock options exercised and share capital issued

    121        —          —          —          121   
                                       

Cash provided by (used in) financing activities

    20,712        (1,352     (40,860     20,000        (1,500
                                       

Effect of exchange rate changes on cash and cash equivalents

    —          1        498        —          499   

Net increase (decrease) in cash and cash equivalents

    8,466        (16,958     (19,919     —          (28,411

Cash and cash equivalents, beginning of year

    23,790        20,334        47,202        —          91,326   
                                       

Cash and cash equivalents, end of year

  $ 32,256      $ 3,376      $ 27,283      $ —        $ 62,915   
                                       

 

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Table of Contents
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

ANGIOTECH PHARMACEUTICALS, INC.

For the three and six months ended June 30, 2009

(All amounts following are expressed in U.S. dollars unless otherwise indicated.)

MANAGEMENT’S DISCUSSION & ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following management’s discussion and analysis (“MD&A”), dated June 30, 2009, provides an update to the MD&A for the year ended December 31, 2008 and should be read in conjunction with our unaudited consolidated financial statements for the three and six months ended June 30, 2009 and our audited consolidated financial statements for the year ended December 31, 2008, each of which has been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Additionally, the MD&A and unaudited consolidated financial statements for the three and six months ended June 30, 2009 have been prepared in accordance with the applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”) for the presentation of interim financial information. Additional information relating to our Company, including our 2008 audited consolidated financial statements and our 2008 Annual Report on Form 10-K (as amended by our Form 10-K/A, the “10-K”), is available by accessing the SEDAR website at www.sedar.com or the SEC’s EDGAR website at www.sec.gov/edgar.shtml.

Forward-Looking Statements and Cautionary Factors That May Affect Future Results

Statements contained in this Quarterly Report on Form 10-Q that are not based on historical fact, including without limitation statements containing the words “believes,” “may,” “plans,” “will,” “estimates,” “continues,” “anticipates,” “intends,” “expects” and similar expressions, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and constitute “forward-looking information” within the meaning of applicable Canadian securities laws. All such statements are made pursuant to the “safe harbor” provisions of applicable securities legislation. Forward-looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for the remainder of 2009 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements.

Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products sold by our partners; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to conduct research and development, to expand manufacturing and commercialization activities; and any other factors that may affect our performance.

In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this Quarterly Report on Form 10-Q to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; our failure to obtain patent protection for discoveries; loss of patent protection resulting from third-party challenges to our patents; commercialization limitations imposed by patents owned or controlled by third parties; our ability to obtain rights to technology from licensors; liability for patent claims and other claims asserted against us; our ability to obtain and enforce timely patent and other intellectual property protection for our technology and products; the ability to enter into, and to maintain, corporate alliances relating to the development and commercialization of our technology and products; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; our ability to restructure and to service our debt obligations; and any other factors referenced in our other filings with the applicable Canadian securities regulatory authorities or the SEC.

For a more thorough discussion of the risks associated with our business, see the section entitled “Risk Factors” in this Quarterly Report on Form 10-Q.

 

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Given these uncertainties, assumptions and risk factors, investors are cautioned not to place undue reliance on such forward-looking statements. Except as required by law, we disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained in this Quarterly Report on Form 10-Q to reflect future results, events or developments.

This Quarterly Report on Form 10-Q contains forward-looking information that constitutes “financial outlooks” within the meaning of applicable Canadian securities laws. We have provided this information to give shareholders general guidance on management’s current expectations of certain factors affecting our business, including our financial results. Given the uncertainties, assumptions and risk factors associated with this type of information, including those described above, investors are cautioned that the information may not be appropriate for other purposes.

Business Overview

We are a specialty pharmaceutical and medical device company that discovers, develops and markets innovative technologies primarily focused on acute and surgical applications. We generate our revenue through our sales of medical products and components, as well as from royalties derived from sales by our partners of products utilizing certain of our proprietary technologies. For the first six months of 2009, we recorded $93.3 million in direct sales of our various medical products and components and $59.6 million in royalties and license fees received from our partners.

Our research and development efforts focus on understanding and characterizing biological conditions that often occur concurrent with medical device implantation, surgery or acute trauma, including scar formation and inflammation, cell proliferation, bleeding and coagulation, infection and tumor tissue overgrowth. Our strategy is to utilize our various technologies in the areas of drugs, drug delivery, surface modification, biomaterials and medical devices to create and commercialize novel, proprietary medical products that reduce surgical procedure side effects, improve surgical outcomes, shorten hospital stays, or are easier or safer for a physician to use.

We develop our products using a proprietary and systematic discovery approach. We use our drug screening capabilities to identify new uses for known pharmaceutical compounds. We look for compounds that address the underlying biological causes of conditions that can occur with medical device implantation, surgery or acute trauma. Once appropriate drugs have been identified, we work to formulate the drug, or a combination of drugs, with our portfolio of drug, drug delivery and surface modification technologies and biomaterials to develop a novel surgical implant or medical device. We have patent protected, or have filed patent applications for, certain of our technology and many of our products and potential product candidates.

We currently operate in two segments: Pharmaceutical Technologies and Medical Products.

Pharmaceutical Technologies

Our Pharmaceutical Technologies segment focuses primarily on establishing product development and marketing collaborations with major medical device, pharmaceutical or biomaterials companies and to date has derived the majority of its revenue from royalties due from partners that develop, market and sell products incorporating our technologies. Currently, our principal revenues in this segment are from royalties derived from sales by Boston Scientific Corporation (“BSC”) of TAXUS ® coronary stent systems incorporating the drug paclitaxel. TAXUS stents have been evaluated by the industry’s most extensive randomized, controlled clinical trial program, with patient follow-up out to five years in some cases. BSC’s controlled clinical trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries. To date, millions of TAXUS stents have been implanted globally.

Medical Products

Our Medical Products segment manufactures and markets a wide range of single-use specialty medical products, primarily medical device products and medical device components. These products are sold directly to end users or other third-party medical device manufacturers. This segment contains two specialized direct sales and distribution organizations as well as significant manufacturing capabilities. Many of our medical products are made using our proprietary manufacturing processes or are protected by our intellectual property. Our Medical Products segment may apply certain of our proprietary technologies to its products to create novel, next-generation medical products to market directly to end users or medical products distributors.

Proprietary Medical Products. Certain of our product lines, which we refer to as our Proprietary Medical Products, are marketed and sold by our two direct sales groups. We believe certain of these product lines contain technology advantages that may provide for more substantial revenue growth potential as compared to our overall product portfolio. Our significant currently marketed Proprietary Medical Products include (i) our Quill SRS wound closure product line, which is marketed and sold by our Surgical Products Sales Group, and (ii) our HemoStream dialysis catheter, our SKATER™ line of drainage catheters, our BioPince full core biopsy device, our EnSnare™ retrieval device and our V+Pad hemostatic pad which are marketed and sold by our Interventional Products Sales Group.

 

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Base Medical Products. Certain of our product lines, which we refer to as our Base Medical Products, represent more mature finished goods product lines in the ophthalmology, biopsy and general surgery areas or medical device components manufactured by us and sold to other third-party medical device manufacturers who assemble those components into finished medical devices. Sales of our Base Medical Products are supported by a small group of direct sales personnel, as well as a network of independent sales representatives and medical product distributors. Sales of our Base Medical Products tend to exhibit greater volatility or slower relative growth, particularly our sales of components to third-party medical device manufacturers, which may be impacted by customer concentration and the business issues that certain of our large customers may face, as well as to a more limited extent by economic and credit market conditions.

Significant Recent Developments

Option™ Inferior Vena Cava Filter . In June 2009, we announced that the United States Food and Drug Administration (“FDA”) had granted 510(k) clearance for the Option™ Inferior Vena Cava (“IVC”) Filter, for use in both permanent and retrievable indications. We commenced commercial sales of the Option IVC Filter in the United States in July 2009.

IVC filters are implanted in patients that are at high risk for developing pulmonary embolism, which can be a life threatening condition. IVC filters are implanted in the inferior vena cava and are designed to catch clot material to prevent it from reaching the lungs, while allowing blood to continue to flow normally. Patients at high risk for pulmonary embolism are typically patients undergoing a significant surgical procedure, trauma patients or patients that have experienced a previous embolic event. IVC filters have been shown in several studies to significantly reduce the risk of pulmonary embolism and related mortality in certain high risk patient populations. In certain cases, once the risk of an embolic event has passed, the IVC filter will be removed in a subsequent surgical procedure. We believe the Option IVC Filter may have a number of potential competitive benefits, which include a unique filter design that may reduce the potential for filter migration after implantation, thereby making the product safer for patients, insertion potential through either the femoral or jugular route, which may make the product easier for a physician to use, and the use of non-thrombogenic material which reduce the risk of blood clots occurring in the filter. We also believe the unique design of the Option IVC Filter may allow physicians to remove or retrieve the device from patients more easily, or after longer periods of time have passed as compared to existing competitive IVC filters.

The Option IVC Filter was approved based upon the results of a United States multi-center prospective clinical trial. The purpose of the clinical trial was to evaluate the device’s safety and efficacy in preventing pulmonary emboli and to assess the ability to retrieve the device from the body up to 175 days following implantation. The results, representing a total of 100 patients, were presented at the 2009 Society of Interventional Radiology conference in San Diego, CA on March 9, 2009. Successful filter implantation was achieved in 100% of the subjects and the retrieval rate in the study was 92.3%. Clinical success, which was achieved in 88% of subjects, was defined as placement of the filter without subsequent pulmonary embolism, significant filter migration or embolization, symptomatic caval thrombosis or other complications requiring filter removal or invasive intervention.

The Option IVC Filter was licensed in March 2008 from our partner Rex Medical L.P. (“Rex Medical”). We are obligated to pay royalties and milestone payments to Rex Medical derived from our sales of the Option IVC Filter. We made a milestone payment of $2.5 million to Rex Medical upon 510(k) clearance of the Option IVC Filter during the second quarter of 2009 and recorded the payment as an intangible asset.

License, Distribution, Development and Supply Agreements with Haemacure Corporation. In June 2009, we announced that we had entered into license, distribution, development and supply agreements for fibrin and thrombin technologies with Haemacure Corporation (“Haemacure”). The collaboration provides us with access to technology for certain of our surgical product candidates which are currently in preclinical development. As part of this collaboration, we have agreed to provide to Haemacure a senior secured bridge financing facility. The senior secured bridge loan will provide $2.5 million to Haemacure in multiple draw-downs throughout 2009. The loan will be senior to all of Haemacure’s existing and future indebtedness, subject to certain exceptions, will bear interest at an annual rate of 10%, compounded quarterly, and will have a term of two years. We may, at our sole discretion, during a period of two years, advance up to an additional $1 million to Haemacure from time to time, in multiple draw-downs, for a total loan amount of $3.5 million. The senior secured bridge loan also has certain equity conversion features and rights to board representation upon conversion. As of June 30, 2009, $1.2 million of the loan has been drawn upon by Haemacure and a further $0.6 million of the loan, which had been accrued at June 30, 2009, was drawn upon subsequent to June 30, 2009. Of the total of $1.8 million paid and accrued, $1.2 million has been classified as other assets and $0.6 million has been classified as prepaid expenses and other current assets.

New TAXUS Regulatory Approvals and Clinical Data. In July 2009, we announced that our partner BSC had received approval from the FDA to market its TAXUS Liberté Long™ paclitaxel-eluting coronary stent system, a next-generation paclitaxel-eluting stent specifically designed for treating more diffuse coronary artery disease with a single coronary stent. At 38 mm, it is the longest available paclitaxel-eluting stent, providing physicians an option that can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs. It affords a more efficient treatment option for the estimated 8 to 10

 

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percent of patients with long lesions. BSC plans to launch the product in the United States in August 2009. In May 2009, we announced that our partner BSC, had received approval from the FDA to market its TAXUS ® Liberté ® Atom™ paclitaxel-eluting coronary stent system, a next-generation paclitaxel-eluting stent specifically designed for treating small coronary vessels. It was approved for use in vessels as small as 2.25 mm in diameter and joins the TAXUS Express Atom™ stent as the only drug-eluting stents (“DES”) approved for small vessel use in the United States.

In May 2009, we announced that our partner BSC had launched the platinum chromium TAXUS Element™ paclitaxel-eluting coronary stent system in select markets worldwide. The platinum chromium TAXUS Element paclitaxel-eluting coronary stent system is the third-generation BSC coronary stent platform that incorporates our research, technology and intellectual property related to the use of paclitaxel. The TAXUS Element stent features BSC’s proprietary platinum chromium alloy, which is designed to enable thinner stent struts, increased flexibility and a lower stent profile while improving radial strength, recoil and radiopacity. In addition, the TAXUS Element stent platform incorporates new balloon technology intended to improve upon BSC’s market-leading Maverick ® balloon catheter technology.

New Independent TAXUS Clinical Data. In May 2009 we announced that our partner BSC had welcomed the publication of an article in the Journal of the American College of Cardiology (JACC) reviewing data on more than 19,000 patients from the Swedish national registry who were evaluated for restenosis, or the re-narrowing or arteries, after percutaneous coronary intervention (“PCI”). The Swedish Coronary Angiography and Angioplasty Registry holds data on all patients undergoing PCI in Sweden. The objective of this independent study was to evaluate restenosis rates of DES’s in patients with and without diabetes in a real-world setting. The article reported that patients who received a TAXUS Liberté paclitaxel-eluting stent had numerically lower incidences of repeat procedures to treat restenosis at two years as compared to patients treated with ‘olimus-based DES’s, including Johnson & Johnson, Inc.’s Cypher ® Stent and Medtronic Inc.’s Endeavor ® Stent.

In the patients with diabetes, the TAXUS Liberté demonstrated a statistically significant lower restenosis rate compared to the Endeavor, which had more than two times the risk of repeat procedures. The JACC article reported that both the TAXUS Liberté stent and BSC’s first-generation paclitaxel-eluting stent, the TAXUS Express, were the only stents in the study showing no increased risk of restenosis for patients with diabetes as compared to those without diabetes. Data for both the Cypher and Endeavor stents indicated significant increased risk of restenosis in patients with diabetes. In addition, the study showed that the TAXUS Liberté had an approximately 23 percent lower restenosis rate at two years compared to the prior-generation TAXUS Express.

The Swedish registry study included four DES brands: TAXUS Liberté, TAXUS Express, Cypher and Endeavor. In total, the registry included 35,478 DES implants during 22,962 procedures in 19,004 patients, with 1,807 restenoses reported over a mean 29-month follow-up period. For the entire study population, the repeat revascularization rate per stent was 3.5 percent after one year and 4.9 percent after two years. Overall, the adjusted risk of restenosis was 1.23 times higher in patients with diabetes than in patients without diabetes. In patients with diabetes, restenosis was higher in the non-TAXUS stents. The sirolimus-eluting Cypher and the zotorolimus-eluting Endeavor had higher restenosis rates in patients with diabetes compared with those in patients without diabetes (1.25 times and 1.77 times, respectively).

New ZILVER ® PTX™ Clinical Data . In April 2009 we announced that our partner Cook Medical Inc. (“Cook”) had reported data that showed that 82 percent of patients who were treated with Cook’s ZILVER PTX paclitaxel-eluting peripheral stent were free from reintervention at two-year follow up. The ZILVER PTX Registry study, involving 792 patients globally, is assessing the safety and efficacy of the ZILVER PTX in treating peripheral artery disease. The most recent results were reported at the 31st International Symposium Charing Cross Controversies Challenges Consensus. Data was compiled at 12 and 24 months for 593 patients and 177 patients respectively. The registry, which enrolled a broad spectrum of patients, includes patients with complex lesions (e.g., long lesions, total occlusions, in-stent restenosis). The corresponding event-free survival rates were 87 percent and 78 percent, and freedom from target lesion revascularization was 89 percent and 82 percent. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six and 12 months and were maintained through 24 months. Detailed evaluation of stent x-rays demonstrated excellent stent integrity through 12 months, confirming previously published results showing 99 percent completely intact stents (less than 1 percent stent fracture rates observed) with a mean follow up of 2.4 years in the challenging superior femoral artery and popliteal arteries, including behind the knee locations.

Financial and Strategic Alternatives Process. Over the last two and a half years, revenue in our Pharmaceutical Technologies segment has declined significantly, primarily due to lower royalties derived from sales by BSC of TAXUS coronary stent systems. This decline in royalty revenue has negatively and materially impacted our liquidity and results of operations. As a result of this and other factors impacting our business and the capital markets, our management and Board of Directors believe a transaction or transactions of significant size and scope may be necessary to meaningfully address liquidity concerns and the working capital needs of our business. Our evaluation of various financial and strategic alternatives continued through the second quarter of 2009. As part of this continuing process, we secured interim senior secured financing for working capital and liquidity purposes in the first quarter of

 

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2009 by way of a credit facility, we amended our credit facility in the second quarter of 2009, and in July 2009 we filed a shelf registration statement on Form S-3 in the United States and a preliminary short form base shelf prospectus in British Columbia and Ontario, as described in more detail below.

Amendment to Credit Facility. On May 29, 2009, we entered into an amendment to our senior secured term loan and revolving credit facility with Wells Fargo Foothill, LLC (“Wells Fargo”) as the sole arranger, administrative agent and lender that we had previously announced in March 2009. This financing originally included a delayed draw secured term loan facility of up to $10.0 million, and a secured revolving credit facility with a borrowing base derived from the value of certain of our finished goods inventory and accounts receivable, providing up to an additional $22.5 million in available credit, subject to certain terms and conditions. The amendment included, among other things, early termination of the term loan facility, which was undrawn at the time of the amendment and was originally scheduled to terminate on August 31, 2009. The amendment also expanded the definition of Permitted Investments and eliminated the $2.5 million availability block, increasing the total available credit under the revolving credit facility to $25.0 million (subject to a borrowing base formula derived from the value of certain of our finished goods inventory and accounts receivable).

Filing of Shelf Registration Statement on Form S-3. On July 23, 2009, we announced that we had filed a shelf registration statement on Form S-3 with the United States Securities and Exchange Commission and a corresponding preliminary short form base shelf prospectus with the securities commissions of British Columbia and Ontario (collectively, the “Offering Documents”). The Offering Documents, when made final and / or declared effective, will allow us to make offerings of Common shares, Class I Preference shares, debt securities, warrants or units for initial aggregate proceeds of up to $250.0 million during the next 25 months to potential purchasers in the United States, British Columbia and Ontario.

Ongoing Clinical Programs

The following discussion describes our product candidates, or certain of our partners’ product candidates, that are being evaluated in ongoing human clinical trials and their stage of development:

Partner Clinical Programs

ZILVER PTX Paclitaxel-Eluting Peripheral Vascular Stent System. The ZILVER PTX paclitaxel-eluting peripheral vascular stent, which is under evaluation in clinical trials being conducted by our partner Cook, is a specialized stent product incorporating our proprietary paclitaxel technology and is designed for placement in diseased arteries in the limbs to restore blood flow. Cook licenses the rights to use paclitaxel with peripheral stents and certain other non-coronary medical devices from us. Under the terms of our license agreement with Cook, we are entitled to receive royalty payments upon the commercial sale of paclitaxel-eluting peripheral vascular stent products, including the ZILVER PTX.

Of patients with PAD, only a quarter indicate any material symptoms. The “silent” nature of this condition can result in a number of patients being diagnosed only when their condition has progressed to the severe stage. In patients with severe PAD whose condition is not improving with risk-factor modification, exercise programs and pharmacological therapy, invasive procedures may need to be carried out. These procedures include angioplasty, stenting or surgery. To date, stent procedures for PAD in the limbs have been limited due to high observed rates of restenosis, as well as risk of stent fracture with existing products, as these stents are exposed and not protected by the patient’s anatomy as with coronary stents.

Cook is a co-exclusive licensee, together with BSC, of our proprietary paclitaxel technology to reduce restenosis following stent placement in PAD. The ZILVER PTX paclitaxel-eluting peripheral stent is designed to reduce restenosis following placement of a stent in PAD patients. The ZILVER PTX is currently undergoing multiple human clinical trials in the United States, Japan, the European Union and selected other countries to assess product safety and efficacy.

In January 2007, Cook released nine-month data from its EU clinical study. The preliminary data presented by Cook on the first 60 patients in the randomized trial, which is examining the safety of using Cook’s ZILVER PTX paclitaxel-eluting stent to treat blockages, or lesions, of the superficial femoral artery (“SFA”) above the knee, indicated that the ZILVER PTX stent showed an equal adverse event rate to conventional angioplasty for treating SFA lesions. The ZILVER PTX stent also displayed a zero-percent fracture rate for 41 lesions at six months and 18 lesions at one year.

In July 2007, Cook announced that the first U.S. patients in a randomized pivotal human clinical trial of ZILVER PTX were treated at Tri-City Medical Center in Oceanside, CA. The trial is designed to randomize patients to receive either the ZILVER PTX stent or balloon angioplasty. Data from this clinical trial is intended to be used to support submission to the FDA for approval in the United States to market the device. In addition, data collected on Japanese and U.S. patients is expected to be combined for the final evaluation of the device and used for regulatory submissions in both markets for approval.

 

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In June 2008, Cook reported positive interim results from the registry arm of a clinical study designed to measure the efficacy of the ZILVER PTX in treating PAD patients, specifically in the treatment of blockages in the femoropopliteal artery. The results were reported by trial investigators at the 2008 SVS Vascular Annual Meeting, and revealed clinical improvement, excellent durability and fracture resistance, high rates of event-free survival (“EFS”) and freedom from target lesion revascularization (“TLR”). Interim data was compiled at six and 12 months using 435 patients and 200 patients, respectively. The corresponding EFS rates were 94% and 84%, and freedom from TLR was 96% and 88%. Evaluation of stent x-rays is ongoing, and currently suggests stent fractures in approximately one percent of cases at six months and less than two percent of cases at 12 months. In addition, the ZILVER PTX stent exhibited no safety concerns and results were better than expected for Trans-Atlantic Inter-Society Consensus class C and D lesions, occlusions, in-stent restenosis and lesions greater than seven centimeters. Follow-up to the registry arm of the study will continue through two years. In April 2009, Cook reported initial data on two-year follow up from this registry that showed that 82% of patients who were treated with the ZILVER PTX were free from reintervention at two-year follow up. These most recent results were reported at the 31st International Symposium: Charing Cross Controversies Challenges Consensus.

In September 2008, Cook announced it had completed enrollment in its pivotal human clinical trial for the ZILVER PTX. The 420 patients enrolled in Cook’s randomized trial include PAD patients treated in Germany, the United States and Japan. On the same date, Cook announced that it had enrolled an additional 780 patients in the European Union, Canada and Korea in a clinical registry to evaluate the safety of the ZILVER PTX device. Those data have been used for submission in Europe for CE Mark approval to market the device there, with additional regulatory submissions pending in additional markets.

Data from Cook’s ZILVER PTX Registry study reported in April 2009 is discussed above under “Significant Recent Developments-New ZILVER PTX Clinical Data.”

TAXUS Element Paclitaxel-Eluting Coronary Stent System. The TAXUS Element stent system is currently being evaluated in BSC’s TAXUS PERSEUS clinical program, which was commenced in July 2007 and is designed for submission to the FDA in an application for approval to market and sell the TAXUS Element stent system in the United States. The PERSEUS clinical program is expected to collectively enroll approximately 1,500 patients at 100 U.S. and international centers. The PERSEUS clinical program will evaluate the safety and efficacy of the TAXUS Element stent in two studies. The first study, TAXUS PERSEUS Workhorse, will evaluate the safety and efficacy of the TAXUS Element stent compared to the TAXUS Express2 stent. This study will evaluate 1,264 patients with “workhorse” lesions from 2.75 to 4.0 mm. The primary endpoint of the workhorse study is target lesion failure at 12 months, and its secondary endpoint is in-segment percent diameter stenosis at nine months. The second study is the TAXUS PERSEUS Small Vessel study, which will compare the TAXUS Element stent to a historic control (TAXUS V de novo bare-metal Express Coronary Stent System). This study will include 224 patients with lesions from 2.25 to 2.75 mm. The primary endpoint of the small vessel study is in-stent late loss at nine months, and its secondary endpoint is target lesion failure at 12 months. Study success is dependent on both endpoints.

TAXUS Petal™ Bifurcation Paclitaxel-Eluting Coronary Stent System. The TAXUS PETAL bifurcation paclitaxel-eluting coronary stent system, which is under evaluation in clinical trials being conducted by BSC, represents a novel BSC coronary stent product candidate that incorporates our research, technology and intellectual property related to the use of paclitaxel. Conventional coronary stents were designed to treat tubular arteries, and are considered less than optimal for the y-shaped anatomy of a bifurcated area of the coronary arteries. The TAXUS PETAL is a specialized coronary stent designed to treat both the main branch and the side branch of a bifurcation by incorporating an innovative side structure (the PETAL strut) in the middle of the stent that opens into a side branch.

In July 2007 BSC initiated the TAXUS PETAL I First Human Use trial, which is expected to enroll a total of 45 patients in New Zealand, France and Germany. The trial is a non-randomized study with an initial assessment of acute performance and safety (including rates of death, myocardial infarction and target vessel revascularization) at 30 days and six months, with continued annual follow-up to occur for five years. Upon successful completion of this study, BSC has indicated that it intends to begin a pivotal trial which if successful would provide a basis for U.S. and international approvals for the commercialization of the TAXUS PETAL stent.

Angiotech Clinical Programs

Bio-Seal™ Lung Biopsy Tract Plug System. Bio-Seal is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydrogel plug. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture. The plug is absorbed into the body after healing of the puncture site has occurred. We are the worldwide manufacturer and distributor of the Bio-Seal Lung Biopsy Tract Plug System, which has already received CE Mark approval and is currently marketed and sold in the European Union.

 

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Bio-Seal has undergone a human clinical trial in the United States which was designed to assess the safety and efficacy of Bio-Seal, with the primary endpoint being reduction in rates of pneumothorax in patients undergoing lung biopsy procedures. The study was designed to provide a basis for FDA clearance for the commercialization of Bio-Seal. The prospective, randomized, controlled clinical trial enrolled and randomized 339 patients at 15 different investigational sites. Inspiratory upright chest x-rays were performed at 30 to 60 minutes, 24 hours and 30 days after treatment. The trial enrolled its first patient in October 2005 and completed enrollment in June 2008. In March 2009, we announced positive results from this clinical trial at the Society of Interventional Radiologists Annual Scientific Meeting in San Diego, CA. The trial demonstrated a statistically significant clinical benefit in the group receiving Bio-Seal. The Bio-Seal treatment arm hit the primary end point of clinical success for rate of absence of pneumothorax at each time period as compared to traditional treatment. Based on the per-protocol population, the clinical success rate was 85% using Bio-Seal and 69% in the control group. This difference was statistically significant (p=0.002). Although not powered for statistical analysis, positive trends were also observed for Bio-Seal subjects as compared to the control group in various secondary endpoints, including fewer Bio-Seal subjects admitted to the hospital for pneumothoraces (9.4% vs. 13.6%), fewer chest tube placements in Bio-Seal patients (3.5% vs. 10.7%), and fewer additional chest x-rays required in Bio-Seal patients (0.6% vs. 5.3%).

Data from this clinical trial study has been submitted to the FDA. The FDA has asked us various questions about the study and our submission and we have responded to all of the questions from the FDA received to date. Upon further review by the FDA, we may either receive 510(k) clearance to market Bio-Seal in the United States or be required to respond to additional questions or conduct additional clinical studies for this product candidate. Upon receiving such further information from the FDA, we will determine the timing of product launch or any further development work necessary to achieve approval should we choose to continue the development of this product candidate.

MultiStem ® Stem Cell Therapy. The MultiStem stem cell therapy is under evaluation in clinical trials being conducted together with our partner Athersys, Inc. (“Athersys”) for the treatment of acute myocardial infarction. MultiStem stem cells are proprietary adult stem cells derived from bone marrow that have demonstrated the ability in laboratory experiments to form a wide range of cell types. MultiStem may work through several mechanisms, but a primary mechanism appears to be the production of multiple therapeutic molecules produced in response to inflammation and tissue damage. We and Athersys believe that MultiStem may represent a unique “off the shelf” stem cell product candidate, based on its potential ability to be used without tissue matching or immunosupression, and its potential capacity for large scale production. We entered into an agreement with Athersys in May 2006 to co-develop and commercialize MultiStem for use in the indications of acute myocardial infarction and peripheral vascular disease. On December 20, 2007, we and Athersys announced we had received authorization from the FDA to commence a phase I human clinical trial to evaluate the safety of MultiStem in the treatment of acute myocardial infarction. Upon completion of a phase I human clinical trial currently being conducted by Athersys, we may assume lead responsibility for further clinical development. We currently own marketing and commercialization rights with respect to this product candidate. On September 22, 2008, as part of certain cost reduction initiatives, we announced a potential amendment of, and reduction in, cash outlays related to our collaboration with Athersys. The final terms of such amendment to our collaboration with Athersys may have an impact on our expected future expenditures for research and development of MultiStem, and the extent of our future financial and commercial commitments and rights relating to this product candidate.

Completed or Suspended Clinical Programs

5-FU-Eluting Central Venous Catheter. Central venous catheters (“CVC”) are usually inserted into critically ill patients for extended periods of time to administer fluids, drugs, and nutrition, as well as facilitate frequent blood draws. Through our proprietary drug identification strategy, we have elected to evaluate 5-Fluorouracil (“5-FU”), a drug previously approved by the FDA for treatment of various types of cancer, as a compound that may help to prevent certain types of infection in patients receiving a CVC. We recently completed a human clinical trial in the United States designed to assess the safety and efficacy of our 5-FU-eluting CVC in preventing various types of catheter related infections. The study was a randomized, single-blind, 960-patient, 25-center study and was designed to evaluate whether our 5-FU-eluting CVC prevents bacterial colonization at least as well as the market-leading anti-infective CVC. On July 10, 2007, we announced that we had completed enrollment of the study, and on October 9, 2007, we announced this study had met its primary statistical endpoint of non-inferiority as compared to the market leading anti-infective CVC (a chlorhexidine / silver sulfadiazine (CH-SS) coated CVC) and indicated an excellent safety profile. In March 2008, we presented the clinical trial data at the 28th International Symposium on Intensive Care and Emergency Medicine in Brussels, Belgium. Based on the clinical trial data, the investigators concluded that our 5-FU CVC met the primary endpoint of the study; specifically that our 5-FU CVC product candidate was non-inferior in its ability to prevent bacterial colonization of the catheter tip when compared to catheters coated with CH-SS. There were no statistically significant differences in the rate of adverse events related to the study devices, or in the rates of catheter-related bloodstream infections. Additionally, there was no evidence for acquired resistance to 5-FU in clinical isolates exposed to the drug for a second time. Based on the positive results achieved in the study, in December 2007 we filed a request for 510(k) clearance from the FDA to market and sell the CVC in the United States and on April 17, 2008, we announced that we had received 510(k) clearance from the FDA to market our 5-FU CVC in the United States but have not yet commercially

 

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launched the product. We are currently developing potential product launch plans as well as evaluating certain product line extensions relating to this clinical program. Should sufficient liquidity and capital resources be available, we anticipate commencing commercialization of this technology during the first half of 2010.

Vascular Wrap™ . Our paclitaxel-eluting mesh surgical implant, or Vascular Wrap, is designed to treat complications, including graft stenosis or restenosis that may occur in connection with vascular graft implants in hemodialysis patients or in patients that have peripheral artery disease. Vascular grafts are implanted in patients in order to bypass diseased blood vessels, or to provide access to the vascular system of kidney failure patients in order to facilitate the process of hemodialysis. In many cases, these vascular grafts fail due to proliferation of cells or scar tissue into the graft (graft stenosis or restenosis), which can negatively impact blood flow through the vascular graft.

In April 2008, we elected to suspend enrollment in our U.S. and EU human clinical trials for our Vascular Wrap product candidate in patients undergoing surgery for hemodialysis access, pending a safety review to evaluate an imbalance of infections observed between the two study groups. As a result of these observations, we elected to notify physicians to suspend further enrollment in the trials, pending a full review of the potential cause of the implant site infections. There are currently no plans to resume enrollment in these clinical trials, however, we are continuing to monitor, evaluate and collect data with respect to the patients that were enrolled in the clinical trial. We are continuing to evaluate alternatives for this program, including potential collaborations, partnerships, divestitures or future clinical development initiatives.

Acquisitions

As part of our business development efforts we have completed several significant acquisitions. Terms of certain of these acquisitions may require us to make milestone or contingent payments upon achievement of certain product development and commercialization objectives. During the six months ended June 30, 2009, we did not complete any significant acquisitions.

Collaboration, License and Sales and Distribution Agreements

In connection with our commercial and research and development efforts, we have entered into various arrangements with corporate and academic collaborators, licensors, licensees and others for the research, development, clinical testing, regulatory approval, manufacturing, marketing and commercialization of certain of our product candidates. Terms of the various license agreements may require us, or our collaborators, to make milestone payments upon achievement of certain product development and commercialization objectives and pay royalties on sales of commercial products, if any, resulting from the collaborations. During six months ended June 30, 2009, we did not enter into any significant collaboration, license or sales and distribution agreements other than the Amended and Restated Distribution and License Agreement with Baxter International, Inc. (“Baxter”) related to our COSEAL ® technology described in and attached to our Quarterly Report on Form 10-Q for the three months ended March 31, 2009. We also entered into the license, distribution, development and supply agreements with Haemacure in June 2009 for fibrin and thrombin technologies (refer to “Significant Recent Developments— License, Distribution, Development and Supply Agreements with Haemacure Corporation”).

Our other significant collaborations, licenses, sales and distribution agreements are listed in the exhibits index to the Form 10-K and may be found at the locations specified therein.

Critical Accounting Policies and Estimates

Our consolidated financial statements are prepared in accordance with U.S. GAAP. These accounting principles require management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. We believe that the estimates and assumptions upon which we rely are reasonable and are based upon information available to us at the time the estimates and assumptions were made. Actual results could differ materially from our estimates.

We believe the following policies to be critical to understanding our financial condition, results of operations, and expectations for the remainder of 2009 because these policies require management to make significant estimates, assumptions and judgments about matters that are inherently uncertain.

 

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Revenue Recognition

 

(i) Royalty revenue

We recognize royalty revenue when we have fulfilled the terms in accordance with the contractual agreement, have no future obligations, the amount of the royalty fee is determinable and collection is reasonably assured. We record royalty revenue from BSC on a cash basis due to our inability to accurately estimate the BSC royalty before we receive the reports and payments from BSC. This results in a one quarter lag between the time we record royalty revenue and the time the associated sales were recorded by BSC.

 

(ii) Product sales

We recognize revenue from product sales, including shipments to distributors, when the product is shipped from our facilities to the customer provided that we have not retained any significant risks of ownership or future obligations with respect to products shipped. We recognize revenue from product sales net of provisions for future returns. These provisions are established in the same period as the related product sales are recorded and are based on estimates derived from our historical experience.

We consider revenue to be realized or realizable and earned when all of the following criteria are met: persuasive evidence of a sales arrangement exists; delivery has occurred or services have been rendered; the price is fixed or determinable; and collectibility is reasonably assured. These criteria are generally met at the time of shipment when the risk of loss and title passes to the customer or distributor.

We include amounts billed to customers for shipping and handling in revenue. The corresponding costs for shipping and handling are included in cost of products sold.

 

(iii) License fees

License fees are comprised of initial fees and milestone payments derived from collaborative and other licensing arrangements. Non-refundable milestone payments are recognized upon the achievement of specified milestones when the milestone payment is substantive in nature, the achievement of the milestone was not reasonably assured at the inception of the agreement and we have no further significant involvement or obligation to perform under the arrangement. Initial fees and non-refundable milestone payments received, which require our ongoing involvement, are deferred and amortized into income on a straight-line basis over the period of our ongoing involvement if no other objective form of measurable performance exists which indicates another method of recognition is more appropriate.

Income tax expense

Income taxes are accounted for under the liability method. Deferred tax assets and liabilities are recognized for the differences between the financial statement and income tax bases of assets and liabilities, and for operating losses and tax credit carry forwards. The carrying value of our net deferred tax assets assumes that we will be able to generate sufficient future taxable income in certain tax jurisdictions to realize the value of these assets. Management evaluates the realizability of the deferred tax assets and assesses the need for any valuation allowance adjustment. A valuation allowance is provided for the portion of deferred tax assets that is more likely than not to be unrealized. Deferred tax assets and liabilities are measured using the enacted tax rates and laws.

Significant estimates are required in determining our provision for income taxes including, but not limited to, accruals for tax contingencies and valuation allowances for deferred income tax assets. Some of these estimates are based on interpretations of existing tax laws or regulations. Our effective tax rate may change from period to period based on the mix of income among the different foreign jurisdictions in which we operate, changes in tax laws in these jurisdictions, and changes in the amount of valuation allowance recorded.

Stock-based compensation

We account for stock-based compensation in accordance with Statement of Financial Accounting Standards (“SFAS”) 123(R) Share-Based Payment, a revision to SFAS 123, Accounting for Stock-Based Compensation. SFAS 123(R) requires us to recognize the grant date fair value of share-based compensation awards granted to employees over the requisite service period. We use the Black-Scholes option pricing model to calculate stock option values, which requires certain assumptions including the future stock price volatility and expected time to exercise. Changes to any of these assumptions, or the use of a different option pricing model (such as the binomial model), could produce a different fair value for stock-based compensation, which could have a material impact on our earnings.

 

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Cash equivalents, short and long-term investments

We invest our excess cash balances in short-term securities, principally investment grade commercial debt and government agency notes. At June 30, 2009, we held one equity security which was classified as available-for-sale, and accordingly, was recorded at fair market value.

As part of our strategic product development efforts, we also invest in or receive as consideration equity securities of certain companies with which we have license or collaboration agreements. The equity securities of some of these companies are not publicly traded and so fair value is not readily available. These investments are recorded using the cost method of accounting and are tested for impairment by reference to anticipated undiscounted cash flows expected to result from the investment, the results of operations and financial position of the investee, and other evidence supporting the net realizable value of the investment.

Intangible assets

Our identifiable intangible assets are primarily comprised of technologies acquired through our business combinations. Intangible assets also include in-licensed proven medical technologies. We amortize intangible assets on a straight-line basis over the estimated life of the technologies, which range from two to twelve years depending on the circumstances and the intended use of the technology. We determine the estimated useful lives for intangible assets based on a number of factors such as legal, regulatory or contractual limitations; known technological advances; anticipated demand for our products; and the existence or absence of competition. We review the carrying value of our intangible assets for impairment indicators at least annually and whenever there has been a significant change in any of these factors listed above. A significant change in these factors may warrant a revision of the expected remaining useful life of the intangible asset, resulting in accelerated amortization or an impairment charge, which would impact earnings. We tested our intangible assets for impairment as at September 30, 2008 and determined that there was no impairment. Given the continued decline in our market value in the fourth quarter of 2008 and the further negative indicators of the economy as a whole, we updated our impairment tests of intangible assets as at December 31, 2008 and determined that there was no impairment. No additional impairment testing was conducted for the three and six months ended June 30, 2009 as there have been no further indicators of impairment since December 31, 2008.

Results of Operations

Overview

 

(in thousands of U.S.$ except per share data)

   Three months ended
June 30,
    Six months ended
June 30,
 
   2009     2008     2009     2008  

Revenues

        

Pharmaceutical Technologies

   $ 17,394      $ 25,589      $ 59,557      $ 54,571   

Medical Products

     47,179        50,533        93,316        98,259   
                                

Total revenues

     64,573        76,122        152,873        152,830   

Operating (loss) income

     (412     (7,284     27,083        (15,920

Other expenses

     (11,682     (20,775     (21,009     (31,716
                                

(Loss) income before income taxes

     (12,094     (28,059     6,074        (47,636

Income tax (recovery) expense

     (217     (1,988     5,507        (5,802
                                

Net (loss) income

   ($ 11,877   ($ 26,071   $ 567      ($ 41,834
                                

Basic and diluted net (loss) income per common share

   ($ 0.14   ($ 0.31   $ 0.01      ($ 0.49

For the three months ended June 30, 2009, we recorded a net loss of $11.9 million ($0.14 basic and diluted net loss per common share), compared to a net loss of $26.1 million ($0.31 basic and diluted net loss per common share) for the three months ended June 30, 2008.

 

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The decrease in net loss of $14.2 million is due to several factors, including: (i) a $11.8 million decrease in research and development costs due primarily to the completion or termination of various of our human clinical trial activities and from certain cost reduction initiatives implemented during 2008; (ii) a decrease in selling, general and administrative costs of $4.2 million, primarily resulting from cost reduction initiatives implemented during the second half of 2008; (iii) a decrease in write-down and loss on redemption of investments of $10.7 million; and (iv) lower interest expense incurred on our Senior Floating Rate Notes due in 2013 (the “Floating Rate Notes”). These factors were partially offset by a reduction of $7.5 million in royalty revenue derived from BSC’s sales of paclitaxel-eluting coronary stent systems, lower medical products sales of $3.4 million and lower gross profit associated with such sales of $2.2 million and an income tax recovery of $0.2 million in the second quarter of 2009 compared to an income tax recovery of $2.0 million in the same period in 2008.

For the first six months of 2009, we recorded a net income of $0.6 million ($0.01 basic and diluted net income per share), compared to a net loss of $41.8 million ($0.49 basic and diluted net loss per share) for the same period in 2008. The shift of $42.4 million from our prior net loss to net income is primarily due to decreases in research and development and selling, general and administrative expenses in the first six months of 2009 as compared to the same period in 2008 as well as the receipt of the $25.0 million payment from Baxter in the first quarter of 2009. These factors were offset by a $19.8 million reduction in royalty revenue derived from BSC’s sales of paclitaxel-eluting coronary stent systems as compared to the same period in 2008, and an income tax expense of $5.5 million recorded in the first six months of 2009 as compared to an income tax recovery of $5.8 million recorded in the same period in 2008.

Revenues

 

(in thousands of U.S.$)

   Three months ended
June 30,
   Six months ended
June 30,
   2009    2008    2009    2008

Pharmaceutical Technologies:

           

Royalty revenue – paclitaxel-eluting stents

   $ 16,085    $ 23,579    $ 30,989    $ 50,782

Royalty revenue – other

     911      1,957      3,118      3,684

License fees

     398      53      25,450      105
                           
   $ 17,394    $ 25,589    $ 59,557    $ 54,571
                           

Medical Products:

           

Product sales

     47,179      50,533      93,316      98,259
                           

Total revenues

   $ 64,573    $ 76,122    $ 152,873    $ 152,830
                           

We operate in two reportable segments:

Pharmaceutical Technologies

Our Pharmaceutical Technologies segment includes royalty revenue generated from licensing our proprietary paclitaxel technology to various partners, as well as revenue derived from the licensing of certain of our biomaterials and other technologies. Currently, our principal revenues in this segment are from royalties derived from sales by BSC of TAXUS coronary stent systems incorporating the drug paclitaxel. Royalty revenue derived from sales of TAXUS stent systems by BSC for the three month period ended June 30, 2009 decreased by 32% as compared to the same period in 2008. The decrease in royalty revenues was a result of lower sales of TAXUS stent systems by BSC, driven primarily by the entry of new competitors into the drug-eluting coronary stent market during the second half of 2008. Royalty revenue for the quarter ended June 30, 2009 was based on BSC’s net sales for the period January 1, 2009 to March 31, 2009 of $252 million, of which $119 million was in the United States, compared to net sales of $353 million for the same quarter in 2008, of which $195 million was in the United States. The average gross royalty rate earned in the three month period ended June 30, 2009 on BSC’s net sales was 6.6% for sales in the United States and 6.2% for sales in other countries, compared to an average rate of 7.3% for sales in the United States and 5.8% for sales in other countries for the same period in 2008.

The average gross royalty rate relating to TAXUS sales in the United States declined during the three months ended June 30, 2009 as compared to the same period of the prior year as a result of our tiered royalty rate structure, whereby we receive higher royalty rates on sales volume above certain contractually established baselines. The average gross royalty rate relating to sales in countries other than the United States increased slightly in the current period due to the impact of relative TAXUS sales by BSC in Japan, where sales are subject to our tiered royalty payment structure, relative to other countries outside of the United States.

 

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Royalty revenue derived from sales of TAXUS stent systems by BSC for the first six months of 2009 decreased by 39% as compared to the same period in 2008. The decrease in royalty revenues was a result of lower sales of TAXUS stent systems by BSC. Royalty revenue for the first six months of 2009 was based on BSC’s net sales for the period October 1, 2008 to March 31, 2009 of $491 million, of which $223 million was in the United States, compared to net sales of $716 million for the same period in 2008, of which $395 million was in the United States. The average gross royalty rate earned in the first six months of 2009 on BSC’s net sales was 6.5% for sales in the United States and 6.1% for sales in other countries, compared to an average rate of 7.4% for sales in the United States and 6.8% for sales in other countries for the same period in 2008.

The average gross royalty rate relating to TAXUS sales in the United States declined during the six months ended June 30, 2009 as compared to the same period in 2008 as a result of our tiered royalty rate structure, whereby we receive higher royalty rates on sales volume above certain contractually established baselines. The average gross royalty rate relating to sales in countries other than the United States increased slightly in the current period due to the impact of increased relative TAXUS sales by BSC in Japan, where sales are subject to our tiered royalty payment structure, relative to other countries outside of the United States. This increase was mitigated slightly by an additional royalty payment we received during the first quarter of 2008 relating to royalties on sales outside of the United States that were owed from prior periods in 2007.

For the six months ended June 30, 2009, license fees increased by $25.3 million as compared to the same period during 2008 due to the $25.0 million payment received from Baxter in the first quarter of 2009.

We expect revenues in our Pharmaceutical Technologies segment may decrease for the remainder of 2009 as compared to revenues recorded in the second half of 2008 and the first half of 2009, primarily as a result of the continued decline in royalty revenues derived from sales by BSC of TAXUS, increased competition from new competitors that entered into the drug-eluting coronary stent market in the United States in the second half of 2008 and the elimination of ongoing royalty payments from Baxter as a result of our entry into the Amended and Restated Distribution and License Agreement. Our royalties derived from sales by BSC of TAXUS declined from $50.8 million in the first half of 2008 to $33.3 million in the second half of 2008 and to $31.0 million in the first half of 2009.

Medical Products

Our Medical Products segment manufactures and markets a range of single-use, specialty medical devices.

Certain of our product lines, which we refer to as our Proprietary Medical Products, are marketed and sold by our two direct sales groups. We believe certain of these product lines contain technology advantages that may provide for more substantial revenue growth potential as compared to our overall product portfolio. Our significant currently marketed Proprietary Medical Products include (i) our Quill SRS wound closure product line, which is marketed and sold by our Surgical Products Sales Group, and (ii) our HemoStream dialysis catheter, our SKATER line of drainage catheters, our BioPince full core biopsy device, our EnSnare™ retrieval device and our V+Pad hemostatic pad, which are marketed and sold by our Interventional Products Sales Group.

Certain of our product lines, which we refer to as our Base Medical Products, represent more mature finished goods product lines in the ophthalmology, biopsy and general surgery areas, or medical device components manufactured by us and sold to other third party medical device manufacturers who assemble those components into finished medical devices. Sales of our Base Medical Products are supported by a small group of direct sales personnel, as well as a network of independent sales representatives and medical product distributors. Sales of our Base Medical Products tend to exhibit greater volatility or slower relative growth, particularly our sales of components to third-party medical device manufacturers, which may be impacted by customer concentration and the business issues that certain of our large customers may face, as well as to a more limited extent by economic and credit market conditions.

Revenue from our Medical Products segment for the three months ended June 30, 2009 was $47.2 million compared to $50.5 million for the same period in 2008. The decrease was primarily related to lower sales of our Base Medical Products. This decrease was offset by higher sales of our Proprietary Medical Products during the period as compared to the same period of 2008.

Sales of our Base Medical Products were $33.7 million during the second quarter of 2009 representing 71% of our total Medical Products segment sales. Sales of our Base Medical Products declined by approximately 13% in the second quarter of 2009 as compared to the second quarter of 2008. The decline in our Base Medical Products sales in the second quarter of 2009 as compared to the second quarter of 2008 is due primarily to lower sales of medical device components to other third-party medical device manufacturers, generally relating to certain customers that have postponed or cancelled orders, or implemented inventory reduction programs in response to changing economic and credit market conditions, and more particularly relating to cancelled orders for surgical needles by one of our largest customers. Manufacturing of surgical needles, as of November 2008, was fully transferred to our facility in Aguadilla, Puerto Rico from our facility in Syracuse, New York. We believe that the closure of our Syracuse production facility in November and the finalization of our move of surgical needle production to Aguadilla, combined with the

 

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difficult economic and credit market environment, may have negatively impacted our Base Medical Product sales during the second quarter of 2009 as compared to the second quarter of 2008. We currently expect that certain of our customers may increase their order levels later in 2009; however, there can be no assurance that we will record sales of surgical needles to these customers at levels observed in prior periods. Sales of our Base Medical Products were also impacted to a lesser extent by foreign currency fluctuations. Excluding the impact of foreign currency changes, revenue would have declined by 10% as compared to the second quarter of 2008.

Sales of our Proprietary Medical Products were $13.5 million during the second quarter of 2009, representing 29% of our total Medical Products segment sales. Sales of Proprietary Medical Products increased by approximately 15% in the second quarter of 2009 as compared to the second quarter of 2008. The increase in sales of our Proprietary Medical Products during the period was primarily the result of higher sales of certain of our product lines, most significantly our Quill SRS product line and our HemoStream dialysis catheter. Sales of our Proprietary Medical Products as compared to the same period of 2008 were also negatively impacted by foreign currency fluctuations. Excluding the impact of foreign currency changes, revenue would have increased by 21% as compared to the second quarter of 2008.

Revenue from our Medical Products segment for the first six months of 2009 was $93.3 million, a decrease of 5% from the $98.3 million of revenue recorded for the same period of 2008, which was due to a 13% decline in sales of our Base Medical Products to $66.8 million from $76.4 million due to factors consistent with the three month period as noted above, offset by increased sales of our Proprietary Medical Products to $26.5 million from $21.8 million due to factors consistent with the three month period as noted above. Excluding the impact of foreign currency changes, revenue would have declined by 1% as compared to the first six months of 2008.

Because we believe certain of our product lines, including our Quill SRS product line, our HemoStream dialysis catheter, and our recently approved Option IVC Filter have a high potential for growth, we expect that revenue in our Medical Products segment will increase during the remainder of 2009 as compared to 2008. This expected growth may be mitigated or offset by lower sales of our Base Medical Products, in particular if our sales of medical devices and device components to third-party customers continue at lower than expected levels.

Expenditures

 

(in thousands of U.S.$)

   Three months ended
June 30,
   Six months ended
June 30,
   2009    2008    2009    2008

License and royalty fees

   $ 2,568    $ 3,661    $ 5,474    $ 8,032

Cost of products sold

     25,682      26,809      49,648      52,658

Research and development

     6,833      18,584      12,930      34,889

Selling, general and administrative

     21,606      25,813      41,178      53,654

Depreciation and amortization

     8,296      8,539      16,560      17,017

In-process research and development

     —        —        —        2,500
                           
   $ 64,985    $ 83,406    $ 125,790    $ 168,750
                           

License and royalty fees on royalty revenue

License and royalty fee expenses include license and royalty payments due to certain of our licensors, primarily relating to paclitaxel-eluting coronary stent system royalty revenue received from BSC. The decrease in this expense in the three and six months ended June 30, 2009 as compared to the same periods in 2008 reflects the decrease in our royalty revenue. We expect license and royalty fee expense to continue to be a significant cost in 2009, commensurate with the amount of royalty revenue we earn.

Cost of products sold

Cost of products sold is comprised of costs and expenses related to the production of our various medical devices, device component and biomaterial products and technologies, including direct labor, raw materials, depreciation and certain fixed overhead costs related to our various manufacturing facilities and operations.

 

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Cost of products sold decreased by $1.1 million to $25.7 million for the three months ended June 30, 2009 compared to $26.8 million for the same period in 2008. Cost of products sold decreased by $3.0 million to $49.7 million for the six months ended June 30, 2009 compared to $52.7 million for the same period in 2008. The decreases in cost of products sold for the three and six months ended June 30, 2009 as compared to the same periods in 2008 were primarily related to the lower levels of aggregate Medical Products segment sales as described above.

Gross margins for our Medical Products segment sales were 45.6% for the three months ended June 30, 2009 compared to 47.0% for the same period in 2008 and were 46.8% for the six months ended June 30, 2009 compared to 46.4% for the same period in 2008. Gross margins in 2009 compared to 2008 were positively impacted by a relative increase in sales of higher margin product lines and the continued launch of certain new, higher margin product lines for which there were no material sales in the comparable prior year period. These positive factors were offset by unfavorable production variances at our Aguadilla, Puerto Rico facility. Specifically, we have incurred costs for labor, inventory, materials and overhead at our Aguadilla facility in anticipation of surgical needle order levels consistent with what was recorded during 2008. With the unexpected cancellation of orders by one of our largest customers at the beginning of 2009, we commenced steps to eliminate excess costs in this facility that were no longer justified by the lower resulting production volumes. These excess costs, the majority of which were capitalized during the past two quarterly periods in anticipation of shipping orders as originally scheduled with our largest customer, are now being written off or expensed over the next two quarterly periods with no concurrent revenue recorded as originally anticipated. These actions have or are expected to negatively impact our Medical Products segment gross margin by approximately three to five percentage points during each of the second quarter and second half of 2009. The actual impact may be higher or lower than anticipated depending on the amount of sales revenue generated.

We expect that cost of products sold will continue to be significant and that gross margins may improve for the remainder of 2009, primarily as a result of improved sales mix, including potential increases in sales of selected product lines that provide higher relative contribution margins. These improvements may be offset if we continue to experience unfavorable manufacturing variances at our Aguadilla, Puerto Rico facility as described above, and as a result, gross margins may not improve as quickly as expected during the remainder of 2009.

Research and development

Our research and development expense is comprised of costs incurred in performing research and development activities, including salaries and benefits, clinical trial and related clinical manufacturing costs, contract research costs, patent procurement costs, materials and supplies, and operating and occupancy costs. Our research and development activities occur in two main areas:

(i) Discovery and pre-clinical research - Our discovery and pre-clinical research efforts are divided into several distinct areas of activity, including screening and pre-clinical evaluation of pharmaceuticals and various biomaterials and drug delivery technologies, evaluation of mechanism of action of pharmaceuticals, mechanical engineering and pursuing patent protection for our discoveries.

(ii) Clinical research and development - Clinical research and development refers to internal and external activities associated with clinical studies of product candidates in humans, and advancing clinical product candidates towards a goal of obtaining regulatory approval to manufacture and market these product candidates in various geographies.

Research and development expenditures decreased significantly to $6.8 million and $12.9 million for the three and six months ended June 30, 2009 respectively, as compared to $18.6 million and $34.9 million for the same periods in 2008. The decreases were primarily due to the suspension of enrollment in our Vascular Wrap clinical trial, the reduction or elimination of staffing within our clinical and research departments and reduction in other direct costs in the second half of 2008 relating to the postponement or elimination of other selected research programs and activities.

We expect our research and development expenditures may continue to be lower in 2009 as compared to 2008, reflecting the factors described above. Even after these expected declines, we anticipate we will continue to incur significant research and development expenditures in 2009.

Selling, general and administrative expenses

Our selling, general and administrative expenses are comprised of direct selling and marketing costs related to the sale of our various medical products, including salaries, benefits and sales commissions, and our various management and administrative support functions, including salaries, commissions, benefits and other operating and occupancy costs.

 

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Selling, general and administrative expenditures were $21.6 million and $41.2 million, respectively, for the three and six months ended June 30, 2009 as compared to $25.8 million and $53.7 million, respectively for the same periods in 2008. The lower expenditures were primarily due to reduced salaries, benefits and travel costs as well as reduced severance and other restructuring charges related to the closure and consolidation of our Syracuse, NY manufacturing facility.

We expect that selling, general and administrative expenses may continue to be lower in 2009 than in 2008 due to staff and other expense reductions implemented primarily during the second half of 2008. Expenditures could materially increase or fluctuate depending on product sales levels, the timing of launch of certain new products and growth of new product sales, or as a result of litigation or other legal expenses that may be incurred to support and defend our intellectual property portfolio or other aspects of our business.

Depreciation and amortization

Depreciation and amortization expense was $8.3 million and $16.6 million, respectively, for the three and six months ended June 30, 2009, compared to $8.5 million and $17.0 million, respectively for the same periods in 2008. Depreciation and amortization expense is comprised of amortization of licensed technologies and identifiable intangible assets purchased through business combinations of $14.8 million and $15.2 million, respectively, and depreciation of property, plant and equipment of $1.7 million and $3.5 million, respectively for the six months ended June 30, 2009.

We expect depreciation and amortization expense in the remainder of 2009 to be comparable to the same periods in 2008.

In-process research and development (“IPR&D”)

We record IPR&D expense relating to acquired or in-licensed technologies that are at an early stage of development and have no alternative future use.

We had no IPR&D expense in either the three or six month periods ended June 30, 2009. In the three month period ended March 31, 2008, we recorded IPR&D expense of $2.5 million for an initial license payment made to Rex Medical to obtain the marketing rights for the Option IVC Filter. We had no IPR&D expense in the three months ended June 30, 2008.

We may incur further IPR&D expenditures in the event we in-license or acquire additional early stage technologies.

Other Income (Expense)

 

(in thousands of U.S.$)

   Three months ended
June 30,
    Six months ended
June 30,
 
   2009     2008     2009     2008  

Foreign exchange (loss) gain

   ($ 1,441   $ 140      ($ 709   $ 563   

Investment and other income

     (600     686        (615     1,442   

Interest expense on long term-debt

     (9,641     (10,941     (19,685     (23,061

Write-down or net loss on redemption of available-for-sale securities

     —          (10,660     —          (10,660
                                

Total other expenses

   ($ 11,682   ($ 20,775   ($ 21,009   ($ 31,716
                                

Net foreign exchange losses during the three and six month periods ended June 30, 2009 were primarily the result of changes in the relationship of the U.S. dollar to other foreign currency exchange rates when translating our foreign currency denominated cash and cash equivalents to U.S. dollars for reporting purposes at period end. We continue to hold foreign currency denominated cash and cash equivalents to meet our anticipated operating and capital expenditure needs in future periods in jurisdictions outside of the United States. We do not use derivatives to hedge against exposures to foreign currency arising from our balance sheet financial instruments and therefore are exposed to future fluctuations in the U.S. dollar to foreign currency exchange rates.

Investment and other income for the three and six months ended June 30, 2009 decreased by $1.3 million and $2.1 million respectively, when compared to the same periods in 2008, primarily as a result of lower interest income received in 2009 due primarily to lower cash balances available to invest. Included in investment and other income for the three and six months ended June 30, 2009 is a charge of $0.6 million relating to the write-off of the portion of the deferred financing charges related to the term loan with Wells Fargo that terminated on May 29, 2009.

 

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During the three and six months ended June 30, 2009, we incurred interest expense of $9.6 million and $19.7 million, respectively, on our outstanding long-term debt obligations, as compared to $10.9 million and $23.1 million, respectively, for the same periods in 2008. The decreases have resulted from a decline in the interest rate applicable on our Floating Rate Notes due to lower LIBOR rates. The interest rate decline resulted in an average interest rate of 4.9% on our Floating Rate Notes for the three months ended June 30, 2009 as compared to 6.4% for the three months ended June 30, 2008. Interest expense also includes $0.6 million for amortization of deferred financing costs for each period presented.

Income Tax

For the three and six months ended June 30, 2009, we recorded an income tax recovery of $0.2 million and an income tax expense of $5.5 million, respectively, compared to an income tax recoveries of $2.0 million and $5.8 million for the three and six months ended June 30, 2008, respectively. The income tax recovery for the three months ended June 30, 2009 was primarily due to the amortization of identifiable intangible assets. The income tax expense for the six months ended June 30, 2009 also includes a $6.1 million write-off of deferred charges relating to taxes paid in prior years in connection with an inter-company transfer of the CoSeal intellectual property underlying the transaction with Baxter.

The effective tax rate for the three and six months ended June 30, 2009 was 1.8% and 90.7% respectively, compared to an effective tax rate of 7.1% and 12.2% respectively, for the comparable periods in 2008. The effective tax rate for the current period was lower than the statutory Canadian tax rate of 30.0% and was primarily due to valuation allowances on net operating losses.

Liquidity and Capital Resources

At June 30, 2009, we had working capital of $68.8 million and cash resources of $50.7 million, consisting of cash and cash equivalents. In aggregate, our working capital increased by $17.2 million as compared to December 31, 2008, primarily relating to the $25.0 million in cash received pursuant to the transaction with Baxter as described above.

In addition, as described above under “Significant Recent Developments—Amendment to Credit Facility,” on May 29, 2009, we entered into an amendment to our senior secured term loan and revolving credit facility with Wells Fargo that we had previously announced in March 2009. This financing originally included a delayed draw secured term loan facility of up to $10.0 million and a secured revolving credit facility, with a borrowing base derived from the value of our finished goods inventory and accounts receivable, providing up to an additional $22.5 million in available credit, subject to certain terms and conditions. The amendment included, among other things, early termination of the term loan facility, which was originally scheduled to terminate on August 31, 2009. The amendment also expanded the definition of Permitted Investments and eliminated a $2.5 million availability block, increasing the total available credit under the revolving credit facility to $25.0 million (subject to a borrowing base formula based on certain of our and our subsidiaries’ finished goods inventory and accounts receivable). As of June 30, 2009, the amount of financing available under the revolving credit facility was approximately $10.7 million and there were no borrowings outstanding under the revolving credit facility.

Our cash resources and any borrowings available under the revolving credit facility, in addition to cash generated from operations or cash available per commitments of certain of our creditors, are used to support our continuing clinical studies, research and development initiatives, sales and marketing initiatives, working capital requirements, debt servicing requirements and for general corporate purposes. We may also use our cash resources to fund acquisitions of, or investments in, businesses, products or technologies that expand, complement or are otherwise related to our business.

At any time, the amount of financing available under the revolving credit facility, which is secured by certain of our inventory and accounts receivable assets, may be significantly less than $25.0 million and is expected to fluctuate from month to month with changes in levels of finished goods and accounts receivable. Any borrowings outstanding under the revolving credit facility bear interest ranging from LIBOR + 3.25% to LIBOR +3.75%, with a minimum Base LIBOR Rate of 2.25%. As the minimum Base LIBOR Rate under the revolving credit facility is 2.25% and the LIBOR rate was 0.66% on June 30, 2009, a 0.5% increase or decrease in the LIBOR rate as of June 30, 2009 would have no impact on interest payable under the credit facility. The revolving credit facility includes certain covenants and restrictions with respect to our operations and requires us to maintain certain levels of Adjusted EBITDA and interest coverage ratios, among other terms and conditions. Repayment of any amounts drawn under the revolving credit facility can be made at certain points in time with ultimate maturity being February 27, 2013. Prepayments made under the revolving credit facility in certain circumstances cannot be re-borrowed by us. We maintain this facility to provide additional liquidity and capital resources for working capital and general corporate purposes in the near term and more flexibility and time to explore other longer-term options for our overall capital structure and working capital needs.

 

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On July 23, 2009, we announced that we filed the Offering Documents with the securities commissions of British Columbia and Ontario and the United States Securities and Exchange Commission. The Offering Documents, when made final and / or declared effective, will allow us to make offerings of Common shares, Class I Preference shares, debt securities, warrants or units for initial aggregate proceeds of up to $250.0 million during the next 25 months to potential purchasers in British Columbia, Ontario and the United States. We believe that having the ability to issue these securities gives us the flexibility to raise capital quickly and effect other long-term changes to our capital structure that we may deem advisable in the future.

Due to numerous factors that may impact our future cash position, working capital and liquidity as discussed below and the significant cash that will be necessary to continue to service our current level of debt obligations, there can be no assurance that we will have adequate liquidity and capital resources to satisfy our financial obligations beyond June 2010.

Our cash inflows and the amounts of expenditures that will be necessary to execute our business plan are subject to numerous uncertainties, including but not limited to changes in drug-eluting coronary stent markets, including the impact of increased competition in such markets and research relating to the efficacy of drug-eluting stents, the sales achieved in such markets by our partner BSC, the timing and success of product sales and marketing initiatives and new product launches, the timing and success of our research, product development and clinical trial activities, the timing of completing certain operational initiatives including facility closures, our ability to effect reductions in certain aspects of our budgets in an efficient and timely manner, and changes in interest rates. These and other uncertainties may adversely affect our liquidity and capital resources to a significant extent and may force us to further reduce our expenditures on research and development or on our various new product and sales and marketing initiatives in order for us to continue to service our debt obligations. Such further reductions in our budgeted expenditures may have an adverse effect on our new product development and sales growth initiatives and reduce our ability to achieve the revenue growth targets, product launch or new product development timelines in our current operating plan. There can also be no assurance that such reductions in expenditures will be adequate to provide sufficient cash flow to continue to service our current level of debt obligations.

In particular, should our royalties received from BSC decline more significantly than we expect in future periods as a result of competition in the drug-eluting stent market or due to negative research or publications relating to the efficacy of drug-eluting stents, our liquidity may continue to be adversely affected, and we may be forced to explore alternative funding sources through debt, equity or other public or private securities offerings, or to pursue certain reorganization, restructuring or other strategic or financial alternatives. We may not be able to complete any restructuring, reorganization or strategic activities on terms that would be favourable for our shareholders. Capital markets conditions deteriorated significantly during 2008 and early 2009, including a significant and material decline in the level of corporate lending activity, combined with a significant increase in the cost of any such lending. Current market conditions may have a material impact on our ability to complete any of the activities as described on favourable terms, if at all.

As a result of uncertainty and volatility relating to the market and competitive environment for drug-eluting stents and to address our liquidity needs, during 2008, we commenced the exploration of a broad range of strategic and financial alternatives (see “Business Overview – Financial and Strategic Alternatives Process”).

Cash Flow Highlights

 

(in thousands of U.S.$)

   Three months ended
June 30,
    Six months ended
June 30,
 
   2009     2008     2009     2008  

Cash and cash equivalents, beginning of period

   $ 64,523      $ 69,792      $ 38,952      $ 91,326   

Net loss excluding non-cash items

     (2,558     (4,170     18,200        (12,388

Working capital requirements

     (4,959     2,183        1,672        (6,041
                                

Cash (used in) provided by operating activities

     (7,517     (1,987     19,872        (18,429

Cash used in investing activities

     (4,634     (3,238     (5,138     (8,981

Cash used in financing activities

     (1,386     (1,536     (2,976     (1,500

Effect of exchange rate changes on cash

     (328     (116     (52     499   
                                

Net (decrease) increase in cash and cash equivalents

     (13,865     (6,877     11,706        (28,411
                                

Cash and cash equivalents, end of period

   $ 50,658      $ 62,915      $ 50,658      $ 62,915   
                                

 

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Cash Flows from Operating Activities

Cash used in operating activities for the quarter ended June 30, 2009 was $7.5 million compared to cash used in operating activities of $2.0 million for the same period in 2008. Net income for the current quarter, excluding non-cash items, resulted in cash outflows of $2.6 million compared to cash outflows of $4.2 million for the same period of 2008. Working capital requirements resulted in cash outflows of $5.0 million for the second quarter of 2009 compared to cash inflows of $2.2 million for the same quarter of 2008. The increase in cash outflows related to working capital for the second quarter of 2009 as compared to the same quarter of 2008 resulted primarily from certain payments related to the terminated transaction with Ares Management and New Leaf Ventures announced in the second half of 2008 as well as an interest payment on the 7.75% Senior Subordinated Notes due in 2014 (the “Subordinated Notes”) we made on March 31, 2008 which was not made until April 1 in 2009 and from the impact of non-cash tax expense.

Cash provided by operating activities for the six months ended June 30, 2009 was $19.9 million compared to cash used in operating activities of $18.4 million for the same period in 2008. The increase in cash provided by operating activities was due primarily to the one-time cash payment of $25.0 million received from Baxter in the first quarter of 2009, reduced research and development and selling, general and administrative costs in 2009 and the impact of working capital changes during the period. Working capital changes included a reduction in net cash outflows from accounts receivable of $3.0 million due to decreased sales at the end of the second quarter of 2008 as compared to the second quarter of 2009, an increase in net cash inflows from prepaid expenses and other assets of $6.4 million due to non-cash tax expense and an increase in net cash inflows from income taxes payable of $3.1 million.

Cash Flows from Investing Activities

Net cash used in investing activities for the quarter ended June 30, 2009 was $4.6 million compared to net cash used of $3.2 million for the same quarter in 2008. For the quarter ended June 30, 2009, the net cash used in investing activities was primarily related to the $2.5 million payment to Rex Medical for the Option IVC Filter as well as the $1.2 million advanced to Haemacure. For the quarter ended June 30, 2008, the net cash used in investing activities was primarily for capital expenditures of $2.4 million, of which $0.3 million was for lab equipment and the expansion of our R&D facilities and $2.1 million was for manufacturing equipment, mainly for the expansion of our Puerto Rico manufacturing facility. We also paid a $0.8 million earn-out milestone payment to a third party upon our successful completion of the Bio-Seal clinical trial.

Net cash used in investing activities for the first six months of 2009 was $5.1 million compared to net cash used of $9.0 million for the same period in 2008. For the first six months of 2009, the net cash used in investing activities was primarily for capital expenditures of $1.7 million as well as the payments made to Rex Medical and Haemacure as described above. For the first six months of 2008, the net cash used in investing activities was primarily for capital expenditures of $5.8 million, of which $1.8 million was for lab equipment and the expansion of our R&D facilities, and $3.9 million was for manufacturing equipment, mainly for the expansion of our Puerto Rico manufacturing facility. We also paid a $0.8 million licensing milestone to a third-party upon our successful completion of the Bio-Seal clinical trial and invested $2.5 million in IPR&D for an initial license payment to Rex Medical, as described above.

Depending on the level of our cash portfolio, we invest our excess cash in short-term marketable securities, principally investment grade commercial debt and government agency notes. Investments are made with the secondary objective of achieving the highest rate of return while meeting our primary objectives of liquidity and safety of principal. Our investment policy limits investments to certain types of instruments issued by institutions with investment grade credit ratings and places restrictions on maturities and concentration by type and issuer. At June 30, 2009, we were not holding any short-term marketable securities.

At June 30, 2009 and December 31, 2008, we retained the following cash and cash equivalents denominated in foreign currencies in order to meet our anticipated foreign operating and capital expenditures in future periods.

 

(in thousands of U.S.$)

   June 30,
2009
   December 31,
2008

Canadian dollars

   $ 1,318    $ 3,942

Swiss franc

     1,355      3,053

Euro

     5,280      5,263

Danish krone

     1,136      2,022

Other

     1,470      2,806
             

 

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Cash Flows from Financing Activities

Net cash used in financing activities for the three and six months ended June 30, 2009 were $1.4 million and $3.0 million, respectively, and were primarily for expenditures related to our senior secured credit facility (see “Liquidity and Capital Resources” above and note 11(c) to unaudited interim consolidated financial statements for three and six months ended June 30, 2009). Net cash used in financing activities for the three and six months ended June 30, 2008 were $1.5 million and were related to payments made as a result of the terminated transaction with Ares and New Leaf.

Senior Floating Rate Notes

On December 11, 2006, we issued Floating Rate Notes in the aggregate principal amount of $325 million. The Floating Rate Notes bear interest at an annual rate of LIBOR plus 3.75%, which is reset quarterly. Interest is payable quarterly in arrears on March 1, June 1, September 1, and December 1 of each year through to maturity. The Floating Rate Notes are unsecured senior obligations, are guaranteed by certain of our subsidiaries and rank equally in right of payment to all of our existing and future senior indebtedness. At June 30, 2009, the interest rate on these notes was 4.41%. We may redeem all or a part of the notes at specified redemption prices.

Senior Subordinated Notes

On March 23, 2006, we issued Subordinated Notes in the aggregate principal amount of $250.0 million. These Subordinated Notes bear interest at an annual rate of 7.75% payable semi-annually in arrears on April 1 and October 1 of each year through to maturity. The Subordinated Notes are unsecured obligations. The Subordinated Notes and related note guarantees provided by us and certain of our subsidiaries are subordinated to our Floating Rate Notes described above, our existing and future senior indebtedness. We may redeem all or a part of the notes at specified redemption prices.

Debt Covenants

The terms of the indentures governing our Floating Rate Notes and our Subordinated Notes include various covenants that impose restrictions on the operation of our business and the business of our subsidiaries, including the incurrence of certain liens and other indebtedness.

In addition, the terms of our senior secured credit facility, include customary financial covenants, including maintaining certain levels of Adjusted EBITDA and interest coverage ratios, as well as covenants that limit our ability to, among other things, incur indebtedness, create liens, merge or consolidate, sell or dispose of assets, change the nature of their business, make distributions and make advances, loans or investments.

Contractual Obligations

During the three and six months ended June 30, 2009, there were no significant changes in our payments due under contractual obligations, as disclosed in our Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in the Form 10-K.

Contingencies

We are party to various legal proceedings, including patent infringement litigation and other matters. See Part II, Item 1 and Note 14(b) “Contingencies”, in the Notes to the Consolidated Financial Statements of Part I, Item 1 of this Quarterly Report on Form 10-Q for more information.

Off-Balance Sheet Arrangements

As of June 30, 2009, we do not have any off-balance sheet arrangements, as defined by applicable securities regulators in Canada and the United States, that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that would be material to investors.

 

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Recently Adopted Accounting Policies

In December 2007, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 141 (Revised 2007), Business Combinations, or SFAS No. 141(R). SFAS No. 141(R) will change the accounting for business combinations. Under SFAS No. 141(R), an acquiring entity will be required to recognize all the assets acquired and liabilities assumed in a transaction at the acquisition-date fair value with limited exceptions. SFAS No. 141(R) will change the accounting treatment and disclosure for certain specific items in a business combination. SFAS No. 141(R) applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. We have adopted this standard but the impact on accounting for business combinations will be dependent upon future acquisitions.

On April 1, 2009, the FASB issued FASB Staff Position (“FSP”) FAS No. 141(R)-1, Accounting for Assets Acquired and Liabilities Assumed in a Business Combination That Arise from Contingencies, to amend and clarify the initial recognition and measurement, subsequent measurement and accounting, and related disclosures arising from contingencies in a business combination under SFAS No. 141(R). FSP FAS No. 141(R)-1 applies to all assets acquired and liabilities assumed in a business combination that arise from contingencies that would be within the scope of FAS No. 5 if not acquired or assumed in a business combination, except for assets or liabilities arising from contingencies that are subject to specific guidance in FAS 141(R). We have adopted this standard but the impact on accounting for business combinations will be dependent upon future acquisitions.

In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements—An Amendment of ARB No. 51, or SFAS No. 160. SFAS No. 160 establishes new accounting and reporting standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a subsidiary. SFAS No. 160 is effective for fiscal years beginning on or after December 15, 2008. Adopting this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In November 2007, the Emerging Issues Task Force (“EITF”) issued EITF Issue 07-01, Accounting for Collaborative Arrangements or EITF Issue 07-01. EITF Issue 07-01 requires collaborators to present the results of activities for which they act as the principal on a gross basis and report any payments received from (made to) other collaborators based on other applicable GAAP or, in the absence of other applicable GAAP, based on analogy to authoritative accounting literature or a reasonable, rational, and consistently applied accounting policy election. Further, EITF Issue 07-01 clarified that the determination of whether transactions within a collaborative arrangement are part of a vendor-customer (or analogous) relationship subject to Issue 01-9, Accounting for Consideration Given by a Vendor to a Customer. EITF Issue 07-01 is effective for fiscal years beginning December 15, 2008. Adoption of this standard has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities or SFAS No. 161. SFAS No. 161 amends and expands the disclosure requirements of SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities. It requires qualitative disclosures about objectives and strategies for using derivatives, quantitative disclosures about fair value amounts of gains and losses on derivative instruments, and disclosures about credit-risk-related contingent features in derivative agreements. This statement is effective for financial statements issued for fiscal years beginning after November 15, 2008. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

In April 2008, the FASB issued FSP FAS No. 142-3, Determination of the Useful Life of Intangible Assets, or FSP FAS No. 142-3. FSP FAS No. 142-3 amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets. The intent of the position is to improve the consistency between the useful life of a recognized intangible asset under SFAS No. 142 and the period of expected cash flows used to measure the fair value of the intangible asset. FSP FAS 142-3 is effective for fiscal years beginning after December 15, 2008. Adoption of this standard has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In June 2008, the EITF issued EITF Issue 08-3, Accounting for Lessees for Maintenance Deposits under Lease Arrangements. EITF Issue 08-3 provides guidance for accounting for nonrefundable maintenance deposits. It also provides revenue recognition accounting guidance for the lessor. EITF Issue 08-3 is effective for fiscal years beginning after December 15, 2008. Adopting this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In June 2008, the EITF reached a consensus on EITF Issue 08-4, Transition Guidance for Conforming Changes to EITF Issue 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios. Subsequent to the issuance of EITF Issue 98-5, certain portions of the guidance contained in EITF Issue 98-5 were nullified by EITF Issue 00-27, Application of EITF Issue 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or

 

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Contingently Adjustable Conversion Ratios. However, the portions of EITF Issue 98-5 that were nullified by EITF Issue 00-27 were not specifically identified in EITF Issue 98-5, nor were the illustrative examples in EITF Issue 98-5 updated for the effects of EITF Issue 00-27. EITF Issue 08-4 specifically addresses the conforming changes to EITF Issue 98-5 and provides transition guidance for the conforming changes. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In June 2008, the FASB ratified EITF Issue 07-5, Determining Whether an Instrument (or an Embedded Feature) is Indexed to an Entity’s Own Stock. EITF Issue 07-5 provides that an entity should use a two step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. It also clarifies the impact of foreign currency denominated strike prices and market-based employee stock option valuation instruments on the evaluation. EITF Issue 07-5 is effective for fiscal years beginning after December 15, 2008. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In September 2008, the FASB ratified EITF Issue 08-5, Issuer’s Accounting for Liabilities Measured at Fair Value With a Third-Party Credit Enhancement. EITF Issue 08-5 provides guidance for measuring liabilities issued with an attached third-party credit enhancement (such as a guarantee). It clarifies that the issuer of a liability with a third-party credit enhancement should not include the effect of the credit enhancement in the fair value measurement of the liability. EITF Issue 08-5 is effective for the first reporting period beginning after December 15, 2008. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In September 2008, the FASB issued FSP 133-1 and FASB Interpretation Number (FIN) 45-4, Disclosures about Credit Derivatives and Certain Guarantees: An Amendment of FASB Statement No. 133 and FASB Interpretation No. 45; and Clarification of the Effective Date of FASB Statement No. 161. FSP 133-1 and FIN 45-4 amends disclosure requirements for sellers of credit derivatives and financial guarantees. It also clarifies the disclosure requirements of SFAS No. 161 and is effective for quarterly periods beginning after November 15, 2008, and fiscal years that include those periods. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

In November 2008, the EITF issued EITF 08-6, Equity method Investment Accounting Considerations. EITF Issue 08-6 addresses a number of matters associated with the impact of SFAS No. 141(R) and SFAS No. 160 on the accounting for equity method investments including initial recognition and measurement and subsequent measurement issues. EITF Issue 08-6 is effective, on a prospective basis, for fiscal years beginning after December 15, 2008 and interim periods within those fiscal years. Adopting this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In November 2008, the EITF issued EITF 08-7, Accounting for Defensive Intangible Assets. EITF Issue 08-7 provides guidance for accounting for defensive intangible assets subsequent to their acquisition in accordance with SFAS No. 141R and SFAS No. 157 including the estimated useful life that should be assigned to such assets. EITF Issue 08-7 is effective for intangible assets acquired on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. We have adopted this standard and the impact on accounting for defensive intangible assets will be dependent upon future acquisitions.

In December 2008, the FASB issued FSP SFAS No. 140-4 and FIN No. 46R-8, Disclosures by Public Entities (Enterprises) about Transfers of Financial Assets and Interests in Variable Interest Entities. This statement increases the disclosure requirements regarding continuing involvement with financial assets that have been transferred, as well as the company’s involvement with variable interest entities. The FSP is effective for financial statements issued for interim periods ending after December 15, 2008. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

On January 12, 2009, the FASB issued FSP EITF No. 99-20-1, Amendments to the Impairment Guidance of EITF Issue 99-20. The FSP eliminates the requirement that a holder’s best estimate of cash flows be based upon those “that a market participant” would use. Instead, the FSP requires that an other-than-temporary impairment be recognized through earnings when it is probable that there has been an adverse change in the holder’s estimated cash flows from the cash flows previously projected. The Staff Position is effective for the first interim period or fiscal year ending after December 15, 2008, and each interim and annual period thereafter. Retroactive application to a prior interim period is not permitted. Adoption of these standards has not had a material impact on our consolidated balance sheets, results of operations or cash flows.

In April 2009, the FASB issued FSP FAS No. 107-1 and APB 28-1, Interim Disclosures about Fair Value of Financial Instruments, or FSP FAS 107-1. FSP FAS 107-1 amends the disclosure requirements of FAS No. 107, Disclosures about Fair Value of Financial Instruments, for interim reporting periods of publicly traded companies as well as in annual financial statements. FSP FAS 107 requires public companies to disclosure the fair value of its financial instruments whenever it issues summarized financial information for interim reporting periods. FSP FAS No. 107-1 is effective for interim periods beginning after June 15, 2009. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

 

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In April 2009, the FASB issued FSP FAS No. 115-2 and FAS No. 124-2, Recognition and Presentation of Other-than-Temporary Impairments, or FSP FAS No. 115-2. FSP FAS No. 115-2 amends the impairment guidance for certain debt securities and will require an investor to assess the likelihood of selling the security prior to recovering the cost basis. If the investor is able to meet the criteria to assert that it will not have to sell the security before recovery, impairment charges related to non-credit losses would be reflected in other comprehensive income. FSP FAS 115-2 is effective for interim periods beginning after June 15, 2009. Adoption of this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In April 2009, the FASB issued FSP FAS No. 157-4, Determining Fair Value When the Volume and Level of Activity for Asset or Liability have significantly Decreased and Identifying Transactions that are Not Orderly, or FSP FAS No. 157-4. FSP FAS No. 157-4 amends FAS No. 157, Fair Value Measurements, to provide additional guidance on fair value measurements in inactive markets. The new approach is designed to address whether a market is inactive, and if so, whether a transaction in that market should be considered distressed. FSP FAS No. 157-4 provides additional guidance on how fair value measurements might be determined in an active market. FSP FAS No. 157-4 is effective for interim periods beginning after June 15, 2009 and shall be applied prospectively. Adoption of this standard did not have a material impact on our consolidated balance sheets, results of operations or cash flows.

In May 2009 the FASB issued SFAS No. 165, Subsequent Events. SFAS No. 165 establishes general standards for the accounting and disclosure of events which occur after the balance sheet date but before the financial statements are issued or are available for issuance. This standard is effective for interim or annual periods ending after June 15, 2009. This standard had no impact on the company’s financial results given that it relates to disclosure and presentation only.

Recent Accounting Pronouncements

In June 2009 the FASB issued SFAS No. 166, Accounting for Transfers of Financial Assets to amend SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities. The new standard features the following changes: elimination of the qualifying special purpose entity concept, introduction of new criteria for the recognition and derecognition of financial asset transfers eligible for sale accounting, and extension of disclosure requirements. SFAS No. 166 is applicable to all financial asset transfers occurring from January 1, 2010. We are assessing the potential impact that the adoption of SFAS 166 may have on our consolidated financial position, results of operations or cash flows.

In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R) – Consolidation of Variable Interest Entities (“VIE’s”). The new standard eliminates the QSPE exemption and defines a new approach for assessing whether VIE’s should be consolidated. SFAS No. 167 is effective for annual and interim periods beginning after November 15, 2009. We are assessing the potential impact that the adoption of SFAS 167 may have on our consolidated financial position, results of operations or cash flows.

Outstanding Share Data

As of June 30, 2009, there were 85,126,725 common shares issued and outstanding for a total of $472.7 million in share capital. At June 30, 2009, we had 5,635,227 CDN dollar stock options outstanding under the Angiotech Pharmaceuticals, Inc. stock option plans (of which 4,099,332 were exercisable and expected to vest) at a weighted average exercise price of CDN$5.91. We also had 2,862,085 U.S. dollar stock options outstanding under the plans at June 30, 2009, (of which 1,877,814 were exercisable and expected to vest) at a weighted average exercise price of US$1.67 per option. Each CDN dollar stock option and U.S. dollar stock option is exercisable for one common share of Angiotech Pharmaceuticals, Inc.

As of June 30, 2009, there were 83 stock options outstanding in the AMI stock option plan (of which 70 were exercisable and expected to vest). Each AMI stock option is exercisable for approximately 3,852 common shares of Angiotech Pharmaceuticals, Inc. upon exercise at a weighted average exercise price of US$15.44 per option.

 

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Item 3. Quantitative and Qualitative Disclosures about Market Risk

The primary objective of our investment activities is to preserve our capital to fund operations. We also seek to maximize income from our investments without assuming significant risk. To achieve our objectives, we maintain a portfolio of cash equivalents and investments in a variety of securities of high credit quality. As of June 30, 2009 we had cash and cash equivalents of $50.7 million.

Interest Rate Risk

As the issuer of the Floating Rate Notes, we are exposed to interest rate risk. The interest rate on the Floating Rate Notes is reset quarterly to 3-month LIBOR plus 3.75%. The aggregate principal amount of the Floating Rate Notes is $325 million and the notes bear interest at a rate of approximately 4.4% (December 31, 2008 – 6.0%). Based upon our average floating rate debt levels during the three months ended June 30, 2009, a 100 basis point increase in interest rates would have impacted our interest expense by approximately $0.8 million for the three months ended June 30, 2009 and June 30, 2008. We do not use derivatives to hedge against interest rate risk.

Foreign Currency Risk

We operate internationally and enter into transactions denominated in foreign currencies. As such, our financial results are subject to the variability that arises from exchange rate movements in relation to the U.S. dollar. Our foreign currency exposures are primarily limited to the Canadian dollar, the Swiss franc, the Danish krone, the Euro and the U.K. pound sterling. We incurred net transaction losses of $1.4 million and $0.7 million for the three and six months ended June 30, 2009, respectively, and net transaction gains of $0.1 million and $0.6 million for the three and six months ended June 30, 2008, respectively, primarily as a result of changes in the relationship of the U.S. to Canadian dollar and other foreign currency exchange rates when translating our foreign currency-denominated cash and cash equivalents to U.S. dollars for reporting purposes at period end. We have not entered into any forward currency contracts or other financial derivatives to hedge foreign exchange risk, and therefore, we are subject to foreign currency transaction and translation gains and losses. We purchase goods and services in U.S. and Canadian dollars, Swiss francs, Danish krone, the Euro and U.K. pound sterling, and earn a significant portion of our license and milestone revenues in U.S. dollars. Foreign exchange risk is managed primarily by satisfying foreign denominated expenditures with cash flows or assets denominated in the same currency.

Since we operate internationally and approximately 13% and 14% of our net revenue for the three months ended June 30, 2009 and June 30, 2008, respectively, were generated in other than the United States dollars, foreign currency exchange rate fluctuations could significantly impact our financial position, results of operations, cash flows and competitive position.

For purposes of specific risk analysis, we used a sensitivity analysis to measure the potential impact to our consolidated financial statements for a hypothetical 10% strengthening of the U.S. dollar compared with the Canadian dollar, the Swiss franc, the Danish kroner, the Euro and the U.K. pound sterling for the three months ended June 30, 2009. Assuming a 10% strengthening of the U.S. dollar, our product net revenue would have been negatively impacted by approximately $2.9 million on an annual basis.

 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures.

Based upon an evaluation of the effectiveness of disclosure controls and procedures, our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”) have concluded that as of the end of the period covered by this Quarterly Report on Form 10-Q our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) were effective to provide reasonable assurance that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified by the rules and forms of the SEC and is accumulated and communicated to management, including the CEO and CFO, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting.

No change was made to our internal control over financial reporting during the three months ended June 30, 2009 that has materially affected, or is reasonably likely to materially affect, such internal control over financial reporting.

 

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PART II—OTHER INFORMATION

 

Item 1. Legal Proceedings

On April 4, 2005, together with BSC, we commenced a legal action in the Netherlands against Sahajanand Medical Technologies Pvt. Ltd. (“SMT”) for patent infringement. On May 3, 2006, the Dutch trial court ruled in favor of Angiotech, finding that Angiotech’s EP (NL) 0 706 376 patent was valid, and that SMT’s Infinnium™ stent infringed the patent. On March 13, 2008, a Dutch Court of Appeal held a hearing to review the correctness of the trial court’s decision. The Court of Appeal released their judgment on January 27, 2009, ruling against SMT (finding the Angiotech patent novel, inventive, and sufficiently disclosed). The Court of Appeal however requested amendment of claim 12 before rendering their decision on infringement. We have filed a response to the Court’s decision, and have additionally filed a further Writ against SMT seeking to prevent SMT from, among other things, use of their CE mark for SMT’s Infinnium™ stent. A date for the court’s decision on infringement has not yet been set. Any decision of the Court of Appeal is appealable to the Supreme Court of the Netherlands.

On March 23, 2006, RoundTable Healthcare Partners, LP as Seller Representative, we as Buyer, and LaSalle Bank (“LaSalle”) as Escrow Agent, executed an Escrow Agreement under which we deposited $20 million with LaSalle. On April 4, 2007, LaSalle received an Escrow Claim Notice issued by us, which directed LaSalle to remit the $20 million to us as Buyer. On or about April 16, 2007, LaSalle received from RoundTable a Notice of Objection to our Escrow Claim Notice. On July 3, 2007, LaSalle filed an action in the Circuit Court of Cook County, Illinois, asking the court to resolve this dispute. After various hearings and discussions, we executed a Joint Letter of Direction allowing the release of $6.5 million to RoundTable, thereby leaving the amount in dispute being approximately $13.5 million. On March 21, 2008, this action was moved to the U.S. District Court Southern District of New York. We are now in the discovery phase of this litigation. On March 20, 2009, Roundtable filed a motion for partial summary judgment and a hearing was held on April 16, 2009. On April 8, 2009, we filed a motion to dismiss certain of the claims in the lawsuit as not yet ripe for resolution. A hearing on our motion was held on April 30, 2009. We do not know when a decision will be issued by the court on either motion.

In July 2004, Dr. Gregory Baran initiated legal action, alleging infringement by Medical Device Technologies Inc. (“MDT”) of two U.S. patents owned by Dr. Baran. These patents allegedly cover MDT’s BioPince™ automated biopsy device. On September 25, 2007, the judge issued her decision pursuant to the Markman hearing (patent claim interpretation) of December 2005. We have submitted a Motion for Summary Judgment to the court based upon the judges’ Markman decision. No hearing date has yet been set by the court.

At the European Patent Office (“EPO”), various patents either owned or licensed by or to us are in opposition proceedings including the following:

 

   

In EP0784490, an oral hearing has been scheduled for October 1, 2009.

 

   

In EP0809515 (which is licensed from (and to) BSC), the EPO held an oral hearing on January 30, 2008 and thereafter revoked this patent. An appeal was filed on April 22, 2008. The parties have been summoned to attend an oral hearing on the appeal at the EPO on June 19, 2009. On February 26, 2009, BSC submitted a request to withdraw from the oral hearing. On June 25, 2009 the EPO issued a notice stating that the decision under appeal was set aside and the patent would be remitted to the patent examiner for further prosecution.

 

   

In EP0830110 (which is licensed from Edwards LifeSciences Corporation) an amended form of this patent was found valid after an oral hearing on September 28, 2006; however, the opponent appealed the decision on December 21, 2006. An oral hearing has been scheduled for September 9, 2009.

 

   

In EP0876166 the EPO held an oral hearing on September 24, 2008, and thereafter revoked this patent. Angiotech filed an appeal on January 19, 2009, and then filed a request to withdraw the appeal on March 10, 2009.

 

   

In EP0975340 (which is licensed from (and to) BSC), an oral hearing was held on December 4, 2008. The EPO issued an Interlocutory Decision on December 23, 2008 stating the patent was found to have met the requirements of the convention. The opponent has appealed this decision. The opponent withdrew their appeal on June 23, 2009, and requested that the patent be maintained in amended form.

 

   

In EP1118325 (which is licensed from the NIH), an oral hearing was held on April 7, 2009, and the patent was upheld. The decision is appealable.

 

   

In EP1155689, briefs are being exchanged.

 

   

In EP1407786 (which is licensed from (and to) BSC), the patent was revoked in a decision from the EPO on December 9, 2008. An appeal was filed on January 30, 2009. An appeal was also filed on behalf of the opponent on April 8, 2009.

 

   

In EP1429664, an oral hearing had been scheduled for May 27, 2009; however, the oral hearing was canceled by the EPO on May 14, 2009. The proceedings will continue in writing.

 

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In EP1159974, briefs are being exchanged.

 

   

In EP1159975, a Notice of Opposition was filed on June 5, 2009. The EPO has not yet set a date for Angiotech’s response.

 

   

In EP0991359, Angiotech’s response to the opposition was due prior to the extended deadline of May 15, 2009 but Angiotech did not file a response. A notice of failure to respond to the opposition was issued by the EPO on July 7, 2009. Angiotech’s response to this notice is due September 7, 2009.

 

   

In EP0876165, the EPO revoked the patent as an outcome of an oral hearing held on June 24, 2009. An appeal may be filed up to August 24, 2009.

 

Item 1A. Risk Factors

You should consider carefully the following information about these risks, together with all of the other information contained within this document. Additional risks and uncertainties not currently known to us or that we currently deem immaterial may impair our business operations. If any of the following risks actually occur, our business, results of operations and financial condition could be harmed.

Risks Related to Our Business

We have historically been unprofitable and may not be able to achieve and maintain profitability

We began operations in 1992 and have incurred a loss from operations in a majority of the years in which we have been operating. Our ability to become profitable and maintain profitability will depend on, among other things, the amounts of royalty revenue we receive from our corporate partners; our ability to restructure our existing indebtedness; our ability to maintain and improve sales of our existing product lines; our ability to successfully market and sell certain new products and technologies; our ability to research, develop and successfully launch new products and technologies; our ability to improve our gross profit margins through realization of lower research and development and general and administrative expenditures, lower manufacturing costs and efficiencies or improved product sales mix; our ability to effectively control our various operating costs; and foreign currency fluctuations.

Our working capital and funding needs may vary significantly depending upon a number of factors including, but not limited to, the level of royalty revenue we receive from corporate partners; our levels of sales and gross profit; costs associated with our manufacturing operations, including capital expenditures, labour and raw materials costs, and our ability to realize manufacturing efficiencies from our various operations; fluctuations in certain working capital items, including inventory and accounts receivable, that may be necessary to support the growth of our business or new product introductions; progress of our research and development programs and costs associated with completing clinical studies and the regulatory process; collaborative and license arrangements with third parties; the cost of filing, prosecuting and enforcing our patent claims and other intellectual property rights; expenses associated with litigation; opportunities to in-license complementary technologies or potential acquisitions; potential milestone or other payments we may make to licensors or corporate partners; and technological and market developments that impact our royalty revenue, sales levels or competitive position in the marketplace.

The decline in TAXUS royalty payments from BSC, the large amount of our outstanding indebtedness and the related cash interest payments due on such indebtedness, the current economic conditions affecting our and our partners’ financial stability, as well as the capital expenditures required to develop the medical products segment of our business, among other factors, have magnified our working capital needs and funding shortages. Our revolving credit facility and recently filed shelf registration statement (when declared effective by the SEC) provide us with the flexibility and time to explore longer-term options for our overall capital structure and working capital needs. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” in this Quarterly Report on Form 10-Q. These longer-term options include one or more financial and strategic alternatives, including a capital influx from one or more new investors and the restructuring of our outstanding indebtedness, but such efforts have not been successful to date due to our significant debt burden. Due to numerous factors that may impact our future cash position, working capital and liquidity, as discussed below, and the significant cash that will be necessary to continue to service our current level of debt obligations, there can be no assurances that we will have adequate liquidity and capital resources to satisfy our financial obligations beyond June 2010. If our cash flows are worse than expected, we may require additional funds in order to meet the funding requirements of our commercial operations for our research and development programs, to satisfy certain contractual obligations, for other operating and capital requirements, for potential acquisitions or in-licensing of technologies, to satisfy milestone or other payment obligations due to licensors or corporate partners, or to repay or refinance our indebtedness. Financing in addition to our credit facility may not be available, and even if available, may not be available on attractive or acceptable terms due to difficult credit markets and other factors.

 

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Our obligation to pay cash interest on our notes has had, and we expect will continue to have, an adverse effect on our liquidity.

We currently have two series of notes outstanding: Senior Floating Rate Notes due 2013 (the “Floating Rate Notes”) and 7.75% Senior Subordinated Notes due 2014 (the “Subordinated Notes”). We are obligated to make periodic cash interest payments on both the Floating Rate Notes and the Subordinated Notes.

As a result of these required cash interest payments, we have had significant liquidity issues. If our cash flows are worse than expected, an inability to access additional sources of liquidity to fund our cash needs, or to refinance our outstanding notes, could further adversely affect our financial condition or results of operations and our ability to make payments on our debt, and could force us to seek the protection of the bankruptcy laws.

During 2008, we commenced certain cost reductions with the goal of achieving positive consolidated free cash flow (after the incurrence of net interest expense). These efforts may not be sufficient to achieve our goal. If further cost reductions beyond those that have been implemented become necessary, our future prospects may be adversely impacted.

In September 2008, we announced that we were pursuing various initiatives to reduce operating costs and focus our business efforts on our most promising near term product opportunities. We have implemented operating cost reductions across all functions in the company, including in research and development and general and administrative functions, with more limited reduction initiatives in sales and marketing. The cost reduction efforts were designed to reduce certain expenses while maintaining support for the sales of our existing marketed product lines. Our remaining resources subsequent to these changes are focused primarily on our existing Medical Products business, and on selected new products that have recently launched or are expected to be launched in the near future. Selected actions that have been taken with respect to the reorganization include postponement of the scheduled launch of our 5-fluorouracil-eluting central venous catheter; discontinuation of our research activities in Rochester, New York; postponement of certain pre-clinical-stage research activities, pending the completion of partnering or other funding activities that would offset direct costs and personnel costs associated with such programs; reduction of certain financial and personnel contributions relating to our joint venture with Genzyme Corporation; rationalization or elimination of office and laboratory space in various locations; rationalization of selected pending and issued intellectual property; elimination of certain expenses and reductions in personnel in all general and administrative and in research and development departments; selective reduction in certain sales and marketing investments personnel and in medical affairs; and postponement of selected planned capital expenditures.

However, the cost reductions implemented to date may not be sufficient to achieve our previously stated goal of achieving positive consolidated free cash flow (after the incurrence of net interest expense). If we are required to make further reductions to our expense levels beyond those that have been implemented, our future business prospects may be adversely impacted.

We depend on BSC for a significant amount of our future revenues and development of TAXUS.

Although the acquisition of our Medical Products segment has diversified our revenue, we anticipate that a significant amount of our revenue for the next few years will be derived from and dependent upon royalty revenues from BSC. We do not have control over the sales and marketing efforts, stent pricing, production volumes, distribution or regulatory environment related to BSC’s paclitaxel-eluting coronary stent program. Our involvement is limited to the terms of our 1997 License Agreement (as amended) with BSC and Cook, which provides for the receipt of royalty revenue based on the net sales of TAXUS and specifies the applicable royalty rates.

Royalty revenue from BSC has declined as described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report on Form 10-Q, which BSC has attributed to a decline in the number of angioplasty procedures in the United States and may decline further in the future. If BSC is impaired in its ability to market and distribute TAXUS, whether for this reason or due to a failure to comply with applicable regulatory requirements, discovery of a defect in the device, increased incidence of adverse events or identification of other safety issues, or previously unknown problems with the manufacturing operations for TAXUS (any of which could, under certain circumstances, result in a manufacturing injunction), our revenues could be further significantly reduced. BSC’s failure to resolve these issues in a timely manner and to the satisfaction of the FDA and other regulatory authorities, or the occurrence of similar problems in the future, could delay the launch of additional TAXUS product lines in the United States and could have a significant impact on our royalty revenue from sales of TAXUS.

Additionally, BSC may terminate our 1997 License Agreement under certain circumstances, including, if BSC is unable to acquire a supply of paclitaxel at a commercially reasonable price; if BSC reasonably determines that the paclitaxel-eluting coronary stent is no longer commercially viable; or if our license agreement with the National Institutes of Health (“NIH”), certain rights under which are sublicensed to BSC, terminates.

 

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The amounts payable by BSC to us vary from 1% to 9% of net sales depending on various factors, including volume of sales from time to time and patent protection laws in the country of sale. From these amounts, we must pay certain royalties to our licensors, including the NIH and the University of British Columbia (“UBC”), under license agreements. The royalty rates paid by BSC to us are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report on Form 10-Q. There is no guarantee that royalty payments under our 1997 License Agreement will continue, and demand for BSC’s paclitaxel-eluting coronary stent products could continue to decline as a result of the factors stated above, as well as competition, technological change, reimbursement or other factors. Also, the royalty rate payable by BSC could decline if and when patent protection expires, or no longer exists as defined by our 1997 License Agreement, in certain jurisdictions.

BSC may be enjoined from the selling, or otherwise become subject to limitations applicable to its ability to sell, TAXUS in the United States.

Our royalty revenue derived from the sale of paclitaxel-eluting coronary stents depends on BSC’s ability to continue to sell its various TAXUS paclitaxel-eluting stent products and to launch next generation paclitaxel-eluting stents in the United States. Historically, stent manufacture and sale is the subject of a substantial amount of U.S. patent litigation, and we anticipate that our licensees, including BSC and others, may be involved in material legal proceedings related to paclitaxel-eluting stents.

Many of the products we are depending on to grow our business are not yet ready for sale or have only recently been introduced for sale.

Many of the products we are depending on to drive future growth are not yet ready for sale or have only recently been introduced for sale. If any of our products are not approved for sale or do not achieve market acceptance, our ability to generate revenues will be adversely affected.

If our products are alleged to be harmful, we may not be able to sell them, we may be subject to product liability claims not covered by insurance and our reputation could be damaged.

The nature of our business exposes us to potential liability risks inherent in the testing, manufacturing and marketing of pharmaceutical products and medical devices. Using our drug candidates or devices in clinical trials may expose us to product liability claims. These risks will expand with respect to drugs or devices, if any, that receive regulatory approval for commercial sale. In addition, some of the products we manufacture and sell are designed to be implanted in the human body for varying periods of time. Even if a drug or device were approved for commercial use by an appropriate governmental agency, there can be no assurance that users will not claim that effects other than those intended may have resulted from our products. Component failures, manufacturing flaws, quality system failures, design defects, inadequate disclosure of product-related risks or product-related information or other safety issues with respect to these or other products we manufacture or sell could result in an unsafe condition or injury to, or death of, a patient. In addition, although many of our products are subject to review and approval by the FDA or other regulatory agencies, under the current state of the law, any approval of our products by such agencies will not prohibit product liability lawsuits from being brought against us in the event that our products are alleged to be defective, even if such products have been used for their approved indications and appropriate labels have been included.

In the event that anyone alleges that any of our products are harmful, we may experience reduced consumer demand for our products or our products may be recalled from the market. In addition, we may be forced to defend individual or class action lawsuits and, if unsuccessful, to pay a substantial amount in damages. A recall of some of our products could result in exposure to additional product liability claims, lost sales and significant expense to perform the recall. The outcome of litigation, particularly class action lawsuits, is difficult to assess or quantify. Plaintiffs in these types of lawsuits often seek recovery of very large or indeterminate amounts, including not only actual damages, but also punitive damages. The magnitude of the potential loss relating to these types of lawsuits may remain unknown for substantial periods of time. In addition, the cost to defend against any future litigation may be significant.

We do not have insurance covering our costs and losses as a result of any recall of products or devices incorporating our technologies whether such recall is instituted by a device manufacturer or us as required by a regulatory agency. Insurance to cover costs and losses associated with product recalls is expensive. If we seek insurance covering product recalls in the future it may not be available on acceptable terms. Even if obtained, insurance may not fully protect us against potential liability or cover our losses. Some manufacturers that suffered such claims in the past have been forced to cease operations or declare bankruptcy.

We do have insurance covering product liability. However, our insurance may not fully protect us from potential product liability claims. If a product liability claim or a series of claims is brought against us in excess of our insurance coverage, our business could suffer. Some manufacturers that suffered such claims in the past have been forced to cease operations or even to declare bankruptcy.

 

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Our success depends on the successful commercialization of our technology.

The successful commercialization of our technology is crucial for our success. Successful product development in the pharmaceutical industry is highly uncertain and very few research and development projects produce a commercial product. Medical devices, pharmaceutical applications and surgical implants utilizing our technology are in various stages of clinical and commercial development and face a variety of risks and uncertainties. Principally, these risks and uncertainties include the following:

 

 

Future clinical trial results may show that some or all of our technology, or the technology of our strategic collaborators that incorporate our technology, is not safe or effective.

 

 

Even if our technology is shown to be safe and effective, we and our strategic collaborators may face significant or unforeseen difficulties in manufacturing our medical devices or the medical devices and surgical implants that use our technology. These difficulties may become apparent when we or our strategic collaborators manufacture the medical devices or surgical implants on a small scale for clinical trials and regulatory approval or may only become apparent when scaling-up the manufacturing to commercial scale.

 

 

Even if our technology-based products are successfully developed, receive all necessary regulatory approvals and are commercially produced, there is no guarantee that there will be market acceptance of them or that they will not cause unanticipated side effects in patients. For example, if drug-eluting stents are found to cause, or are perceived to be the cause of, blood clots in patients, then sales of our drug-eluting stent products may be adversely affected. In addition, there is no guarantee that there will be market acceptance of our products. Our ability to achieve market acceptance for any of our products will depend on a number of factors, including whether or not competitors may develop technologies which are superior to or less costly than our technology-based products, and whether governmental and private third-party payers provide adequate coverage and reimbursement for our products, with the result that our technology-based products, even if they are successfully developed, manufactured and approved, may not generate significant revenues.

If we are unsuccessful in dealing with any of these risks, or if we are unable to successfully commercialize our technology for some other reason, it would likely seriously harm our ability to generate revenue.

We depend on our strategic collaborators for the development, regulatory approval, testing, manufacturing and the potential commercialization of our products.

Historically, our strategy has been to enter into various arrangements with corporate and academic collaborators, licensors, licensees and others for the research, development, clinical testing, regulatory approval, manufacturing, marketing and commercialization of our product candidates. For instance, we collaborate with BSC and Cook to develop and market paclitaxel-eluting coronary and peripheral stents. Strategic collaborators, both existing (particularly BSC) and those that we may collaborate with in the future, are or may be essential to the development of our technology and potential revenue and we have little control over or access to information regarding our collaborators’ activities with respect to our products.

Our strategic collaborators may fail to successfully develop or commercialize our technology to which they have rights for a number of reasons, including:

 

 

failure of a strategic collaborator to continue, or delays in, its funding, research, development and commercialization activities;

 

 

the pursuit or development by a strategic collaborator of alternative technologies, either on its own or with others, including our competitors, as a means for developing treatments for the diseases targeted by our programs;

 

 

the preclusion of a strategic collaborator from developing or commercializing any product, through, for example, litigation or other legal action; and

 

 

the failure of a strategic collaborator to make required milestone payments, meet contractual milestone obligations or exercise options which may result in our terminating applicable licensing arrangements.

We have and we expect that we will continue to enter into licensing agreements with third parties to give us access to technologies that we may use to develop products through our strategic collaboration and partnership arrangements. The technologies governed by these license agreements may be critical to our ability to maintain our competitive advantage in our existing products and to develop future products. For example, through licenses with NIH and UBC, we have been granted access to technologies that have contributed to the development of the TAXUS paclitaxel-eluting coronary stent.

 

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Pursuant to terms of existing license agreements, licensors have the ability to terminate their respective licenses upon the occurrence of certain specified circumstances. Events which may allow licensors to exercise these termination provisions include our bankruptcy, sub-licensing without the licensor’s consent, a transaction which results in a change of control of us, our failure to use the required level of diligence efforts to develop, market and sell products based on the licensed technology, our failure to maintain adequate levels of insurance with respect to the licensed technologies or other acts or omissions that may constitute a breach by us of our license agreement. In addition, any failure to continue to have access to these technologies may materially affect the benefits that we currently derive from the collaboration and partnership arrangements and may negatively impact our results and operations.

If our process related to product development does not result in an approved and commercially successful product, our business could be adversely affected.

We focus our research and development activities on areas in which we have particular strengths. The outcome of any development program is highly uncertain, notwithstanding how promising a particular program may seem. Success in pre-clinical and early-stage clinical trials may not necessarily translate into success in large scale clinical trials. Further, to be successful in clinical trials, increased investment will be necessary, which will adversely affect our short-term profitability.

In addition, we will need to obtain and maintain regulatory approval in order to market new products. Notwithstanding the outcome of clinical trials for new products, regulatory approval may not be achieved. The results of clinical trials are susceptible to varying interpretations that may delay, limit or prevent approval or result in the need for post-marketing studies. In addition, changes in regulatory policy for product approval during the period of product development and review by regulators of a new application may cause delays or rejection. Even if we receive regulatory approval, this approval may include limitations on the indications for which we can market the product. There is no guarantee that we will be able to satisfy the applicable regulatory requirements, and we may suffer a significant variation from planned revenue as a result.

Our planned clinical trials may not begin on time, or at all, and our planned and ongoing clinical trials may not be completed on schedule, or at all.

The commencement or completion of any of our clinical trials may be delayed or halted for numerous reasons, including, but not limited to, the following:

 

 

the FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;

 

 

the data and safety monitoring committee of a clinical trial recommends that a trial be placed on hold or suspended;

 

 

patients do not enroll in clinical trials at the rate we expect;

 

 

patients are not followed-up at the rate we expect;

 

 

patients experience adverse side effects or events related to our products;

 

 

patients die or suffer adverse medical effects during a clinical trial for a variety of reasons, including the advanced stage of their disease and medical problems, which may or may not be related to our product candidates;

 

 

regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials if investigators find us not to be in compliance with regulatory requirements;

 

 

the failure of our manufacturing process to produce finished products which conform to design and performance specifications;

 

 

changes in governmental regulations or administrative actions;

 

 

the interim results of the clinical trial are inconclusive or negative;

 

 

pre-clinical or clinical data is interpreted by third parties in different ways;

 

 

our clinical trial expenditures are constrained by our budgetary considerations; or

 

 

our trial design, although approved, is inadequate to demonstrate safety and/or efficacy.

Clinical trials may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient follow-up in clinical trials depend on many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites and the eligibility criteria for the study and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires

 

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them to undergo extensive post-treatment procedures to assess the safety and effectiveness of our products, or they may be persuaded to participate in contemporaneous trials of competitive products. Delays in patient enrollment or failure of patients to continue to participate in a study may cause an increase in costs and delays or may result in the failure of the trial.

Our clinical trial costs will increase if we have material delays in our clinical trials or if we need to perform more or larger clinical trials than planned. Adverse events during a clinical trial could cause us to repeat a trial, terminate a trial or cancel an entire program.

Pre-clinical development is a long, expensive and uncertain process, and we may terminate one or more of our pre-clinical development programs.

We may determine that certain pre-clinical product candidates or programs do not have sufficient potential to warrant the allocation of resources. Accordingly, we may elect to terminate our programs for such product candidates. If we terminate a pre-clinical program in which we have invested significant resources, our prospects will suffer, as we will have expended resources on a program that will not provide a return on our investment and we will have missed the opportunity to have allocated those resources to potentially more productive uses.

We may not be able to protect our intellectual property or obtain necessary intellectual property rights from third parties, which could adversely affect our business.

Our success depends, in part, on ensuring that our intellectual property rights are covered by valid and enforceable patents or effectively maintained as trade secrets and our ability to detect violations of our intellectual property rights and enforce such rights against others.

The validity of our patent claims depends, in part, on whether prior art references described or rendered obvious our inventions as of the filing date of our patent applications. We may not have identified all prior art, such as U.S. and foreign patents, published applications or published scientific literature that could adversely affect the validity of our issued patents or the patentability of our pending patent applications. For example, patent applications in the United States are maintained in confidence for up to 18 months after their filing. In some cases, however, patent applications remain confidential in the U.S. Patent and Trademark Office, which we refer to as the U.S. Patent Office, for the entire time prior to issuance as a U.S. patent. Patent applications filed in countries outside the United States are not typically published until at least 18 months from their first filing date. Similarly, publication of discoveries in scientific or patent literature often lags behind actual discoveries. Therefore, we cannot be certain that we were the first to invent, or the first to file patent applications related to, our technology. In the event that a third party has also filed a U.S. patent application covering a similar invention, we may have to participate in an adversarial proceeding, known as an interference, declared by the U.S. Patent Office to determine priority of invention in the United States. It is possible that we may be unsuccessful in the interference, resulting in a loss of some portion or all of our U.S. patent positions. The laws in some foreign jurisdictions do not protect intellectual property rights to the same extent as in the United States, and many companies have encountered significant difficulties in protecting and defending such rights in foreign jurisdictions. If we encounter such difficulties or we are otherwise precluded from effectively protecting our intellectual property rights in foreign jurisdictions, our business prospects could be substantially harmed.

We frequently seek patents to protect our intellectual property. It should be recognized that we may not be able to obtain patent protection for key elements of our technology, as the patent positions of pharmaceutical, biotechnology and medical device companies are uncertain and involve complex legal and factual questions for which important legal issues are largely unresolved. For example, no consistent policy has emerged regarding the scope of health-related patent claims that are granted by the U.S. Patent Office or enforced by the U.S. federal courts. Rights under any of our issued patents may not provide us with commercially meaningful protection for our products or afford us a commercial advantage against our competitors or their competitive products or processes. In addition, even if a patent is issued, the coverage claimed in a patent application may be significantly reduced in the patent as granted.

There can be no assurance that:

 

 

patent applications will result in the issuance of patents;

 

 

additional proprietary products developed will be patentable;

 

 

licenses we have obtained from third parties that we use in connection with our technology will not be terminated;

 

 

patents issued will provide adequate protection or any competitive advantages;

 

 

patents will not be successfully challenged by any third parties; or

 

 

the patents of others will not impede our or our collaborators’ ability to commercialize our technology.

 

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For example, the drug paclitaxel is itself not covered by composition of matter patents. Therefore, although we are developing an intellectual property portfolio around the use of paclitaxel for intended commercial applications, others may be able to engage in off-label use of paclitaxel for the same indications, causing us to lose potential revenue. Furthermore, others may independently develop similar products or technologies or, if patents are issued to us, design around any patented technology developed by us, which could affect our potential to generate revenues and harm our results of operations.

Patent protection for our technology may not be available based on prior art. The publication of discoveries in scientific or patent literature often lags behind actual discoveries. As a consequence, there may be uncertainty as to whether we or a third party were the first creator of inventions covered by issued patents or pending patent applications or that we or a third party were the first to file patent applications for such inventions. Moreover, we might have to participate in interference proceedings declared by the U.S. Patent Office, or other proceedings outside the United States, including oppositions, to determine priority of invention or patentability, which could result in substantial cost to us even if the outcome were favourable. An unfavourable outcome in an interference or opposition proceeding could preclude us, our collaborators and our licensees from making, using or selling products using the technology or require us to obtain license rights from prevailing third parties. We do not know whether any prevailing party would offer us a license on commercially acceptable terms, if at all. We may also be forced to pay damages or royalties for our past use of such intellectual property rights, as well as royalties for any continued usage.

As part of our patent strategy, we have filed a variety of patent applications internationally. Oppositions have been filed against various granted patents that we either own or license and which are related to certain of our technologies. See “Legal Proceedings” elsewhere in this Quarterly Report on Form 10-Q for a discussion of the proceedings related to certain of such oppositions.

Our future success and competitive position depend in part on our ability to obtain and maintain certain proprietary intellectual property rights used in our approved products and principal product candidates. Any such success depends in part on effectively prosecuting claims against others who we believe are infringing our rights and by effectively defending claims of intellectual property infringement brought by our competitors and others. The stent-related markets have experienced rapid technological change and obsolescence in the recent past, and our competitors have strong incentives to attempt to stop or delay us from introducing new products and technologies. See “—We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.”

We do not know whether the patents that we have obtained or licensed, or may be able to obtain or license in the future, would be held valid or enforceable by a court or whether a competitor’s technology or product would be found to infringe such patents. Further, we have no assurance that third parties will not properly or improperly modify or terminate any license they have granted to us.

We have obtained licenses from third parties with respect to their intellectual property that we use in connection with our technology. However, we may need to obtain additional licenses for the development of our current or future products. Licenses may not be available on satisfactory terms or at all. If available, these licenses may obligate us to exercise diligence in bringing our technology to market and may obligate us to make minimum guarantee or milestone payments. This diligence and these milestone payments may be costly and could adversely affect our business. We may also be obligated to make royalty payments on the sales, if any, of products resulting from licensed technology and may be responsible for the costs of filing and prosecuting patent applications. These costs could affect our results of operations and decrease our earnings.

Certain of our key technologies include trade secrets and know-how that may not be protected by patents. There can be no assurance that we will be able to protect our trade secrets. To help protect our rights, we undertake to require employees, consultants, advisors and collaborators to enter into confidentiality agreements. We cannot assure you that all employees, consultants, advisors and collaborators have signed such agreements, or that these agreements will adequately protect our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure. Furthermore, we may not have adequate remedies for any such breach. Any disclosure of confidential data into the public domain or to third parties could allow our competitors to learn our trade secrets and use the information in competition against us.

If certain single-source suppliers fail to deliver key product components in a timely manner, our manufacturing ability would be impaired and our product sales could suffer.

We depend on certain single-source suppliers that supply components used in the manufacture of certain of our products. If we need alternative sources for key component parts for any reason, these component parts may not be immediately available to us. If alternative suppliers are not immediately available, we will have to identify and qualify alternative suppliers, and production of these components may be delayed. We may not be able to find an adequate alternative supplier in a reasonable time period or on commercially acceptable terms, if at all. Shipments of affected products have been limited or delayed as a result of such problems in the past, and similar problems could occur in the future. Our inability to obtain our key source supplies for the manufacture of our products may require us to delay shipments of products, harm customer relationships or force us to curtail or cease operations.

 

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If physicians do not recommend and endorse our products or products that use our technology, or if our working relationships with physicians deteriorate, our products or products that use our technology may not be accepted in the marketplace, which could adversely affect our sales and royalty revenues.

In order for us to sell our products or continue to receive royalty revenues from the sale of products that use our technologies, physicians must recommend and endorse them. We believe that recommendations and endorsements by physicians will be essential for market acceptance of our products, and we do not know whether we will obtain the necessary recommendations or endorsements from physicians. Acceptance of our products or of products that use our technology depends on educating the medical community as to the distinctive characteristics, perceived benefits, safety, clinical efficacy and cost-effectiveness of these products compared to products of competitors, and on training physicians in the proper application of these products. If we are not successful in obtaining the recommendations or endorsements of physicians for our products or our collaborators are not successful in doing the same for their products that use our technology, our sales and royalty revenues may not increase or may decline.

In addition, if we fail to maintain our working relationships with physicians, many of our products may not be developed and marketed in line with the needs and expectations of professionals who use and support our products. The research, development, marketing and sales of many of our new and improved products is dependent upon our maintaining working relationships with physicians. We rely on these professionals to provide us with considerable knowledge and experience regarding our products and the marketing of our products. Physicians assist us as researchers, marketing consultants, product consultants, inventors and as public speakers. If we are unable to maintain our strong relationships with these professionals and continue to receive their advice and input, the development and marketing of our products could suffer, which could adversely affect the acceptance of our products in the marketplace and our sales.

If we are unable to license new technologies to utilize in the development of products, or our existing license agreements are terminated, our ability to maintain our competitive advantage in our existing products and to develop future products may be adversely affected.

We have entered into, and we expect that we will continue to enter into, licensing agreements with third parties to give us access to technologies that we may use to develop products through our strategic collaboration and partnership arrangements. The technologies governed by these license agreements may be critical to our ability to maintain our competitive advantage in our existing products and to develop future products. For example, through licenses with the NIH and UBC, we have been granted access to technologies that have contributed to the developments of the TAXUS paclitaxel-eluting coronary stent.

Pursuant to terms of our existing license agreements, licensors have the right under certain specified circumstances to terminate their respective licenses. Events that may allow licensors to exercise these termination provisions include:

 

 

our bankruptcy;

 

 

sub-licensing without the licensor’s consent;

 

 

a transaction which results in a change of control of us;

 

 

our failure to use the required level of diligence to develop, market and sell products based on the licensed technology;

 

 

our failure to maintain adequate levels of insurance with respect to the licensed technologies; or

 

 

other acts or omissions that may constitute a breach by us of our license agreement.

In addition, any failure to continue to have access to these technologies may materially adversely affect the benefits that we currently derive from our collaboration and partnership arrangements and may adversely affect our results and operations.

Compulsory licensing and/or generic competition may affect our business in certain countries.

In a number of countries, governmental authorities and other groups have suggested that companies which manufacture medical products (i.e., pharmaceuticals and medical devices) should make products available at a low cost. In some cases, governmental authorities have held that where a pharmaceutical or medical device company does not do so, their patents might not be enforceable to prevent generic competition. Alternatively, some governmental authorities could require that we grant compulsory licenses to allow competitors to manufacture and sell their own versions of our products, thereby reducing our sales or the sales of our licensee(s). In all of these situations, the results of our operations in these countries could be adversely affected.

 

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We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.

In connection with maintaining the value of our various intellectual property and exclusivity rights, we regularly evaluate the activities of others worldwide. Our success will depend, in part, on our ability to obtain patents, or licenses to patents, maintain trade secret protection and enforce our rights against others. Should it become necessary to protect those rights, we intend to pursue all cost-efficient strategies, including, when appropriate, negotiation or litigation in any relevant jurisdiction. For a summary of certain of our current legal proceedings, see “Legal Proceedings” elsewhere in this Quarterly Report on Form 10-Q.

We intend to pursue and to defend vigorously any and all actions of third parties related to our material patents and pioneering technology. Any failure to obtain and protect intellectual property could adversely affect our business and our ability to operate could be hindered by the proprietary rights of others.

Our involvement in intellectual property litigation could result in significant expense, adversely affecting the development of product candidates or sales of the challenged product or intellectual property and diverting the efforts of our technical and management personnel, whether or not such litigation is resolved in our favor. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources and intellectual property litigation may be used against us as a means of gaining a competitive advantage. Competing parties frequently file multiple suits to leverage patent portfolios across product lines, technologies and geographies and to balance risk and exposure between the parties. Uncertainties resulting from the initiation and continuation of any litigation could affect our ability to continue our operations. In the event of an adverse outcome as a defendant in any such litigation, we may, among other things, be required to:

 

 

pay substantial damages or back royalties;

 

 

cease the development, manufacture, use or sale of product candidates or products that infringe upon the intellectual property of others;

 

 

expend significant resources to design around a patent or to develop or acquire non-infringing intellectual property;

 

 

discontinue processes incorporating infringing technology; or

 

 

obtain licenses to the infringed intellectual property.

We cannot be assured that we will be successful in developing or acquiring non-infringing intellectual property or that necessary licenses will be available upon reasonable terms, if at all. Any such development, acquisition or license could require the expenditure of substantial time and other resources and could adversely affect our business and financial results. If we cannot develop or acquire such intellectual property or obtain such licenses, we could encounter delays in any introduction of products or could find that the development, manufacture or sale of products requiring such licenses could be prohibited.

If third parties file patent applications, or are issued patents claiming technology also claimed by us in pending applications, we may be required to participate in interference proceedings with the U.S. Patent Office, or other proceedings outside the United States, including oppositions, to determine priority of invention or patentability, which could result in substantial cost to us even if the eventual outcome were favorable.

Our ability to operate could be hindered by the proprietary rights of others.

A number of pharmaceutical, biotechnology and medical device companies as well as research and academic institutions have developed technologies, filed patent applications or received patents on various technologies that may be related to our business. Some of these technologies, applications or patents may conflict with or adversely affect our technologies or intellectual property rights, including those that we license from others. We are aware of other parties holding intellectual property rights that may represent prior art or other potentially conflicting intellectual property, including stents coated with agents intended to reduce restenosis. Any conflicts with the intellectual property of others could limit the scope of the patents, if any, that we may be able to obtain or result in the denial of our current or future patent applications altogether.

If patents that cover our activities are issued to other persons or companies, we could be charged with infringement. In the event that other parties’ patents cover any portion of our activities, we may be forced to develop alternatives or negotiate a license for such technology. We do not know whether we would be successful in either developing alternative technologies or acquiring licenses upon reasonable terms, if at all. Obtaining any such licenses could require the expenditure of substantial time and other resources and could harm our business and decrease our earnings. If we do not obtain such licenses, we could encounter delays in the introduction of our products or could find that the development, manufacture or sale of products requiring such licenses is prohibited.

 

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Technological advances and evolving industry standards could reduce our future product sales, which could cause our revenues to grow more slowly or decline.

The markets for our products are characterized by rapidly changing technology, changing customer needs, evolving industry standards and frequent new product introductions and enhancements. The emergence of new industry standards in related fields may adversely affect the demand for our products. This could happen, for example, if new standards and technologies emerged that were incompatible with customer deployments of our applications. In addition, any compounds, products or processes that we develop may become obsolete or uneconomical before we recover any of the expenses incurred in connection with their development. We cannot assure you that we will succeed in developing and marketing product enhancements or new products that respond to technological change, new industry standards, changed customer requirements or competitive products on a timely and cost-effective basis. Additionally, even if we are able to develop new products and product enhancements, we cannot assure you that they will achieve market acceptance.

We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no such claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper or prevent our ability to commercialize certain product candidates, which could severely harm our business.

We may incur significant costs complying with environmental laws and regulations.

Our research and development processes and manufacturing operations involve the use of hazardous materials. We are subject to federal, state, provincial, local and other laws and regulations in the countries in which we operate or sell our products, which govern the use, manufacture, storage, handling and disposal of such materials and certain waste products. The risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of an accident or the discovery of pre-existing contamination at one or more of our facilities, we could be held liable for any damages that result and any such liability could exceed our resources. We may not be specifically insured with respect to this liability, and we do not know whether we will be required to incur significant costs to comply with environmental laws and regulations in the future, or whether our operations, business or assets will be harmed by current or future environmental laws or regulations.

We face and will continue to face significant competition.

Competition from pharmaceutical companies, medical device companies, biotechnology companies and academic and research institutions is intense and is expected to increase. Many of our competitors and potential competitors have substantially greater product development capabilities, experience conducting clinical trials and financial, scientific, manufacturing, sales and marketing resources and experience than our company. We also face competition from non-medical device companies, such as pharmaceutical companies, which may offer non-surgical alternative therapies for disease states which are currently or intended to be treated using our products. Other companies may:

 

 

develop and obtain patent protection for products earlier than us;

 

 

design around patented technology developed by us;

 

 

obtain regulatory approvals for such products more rapidly;

 

 

have greater manufacturing capabilities and other resources;

 

 

have larger or more experienced sales forces;

 

 

develop more effective or less expensive products; or

 

 

have greater success in obtaining adequate third-party payer coverage and reimbursement for their competing products.

 

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While we intend to expand our technological capabilities in order to remain competitive, there is a risk that:

 

 

research and development by others will render our technology or product candidates obsolete or non-competitive;

 

 

treatments or cures developed by others will be superior to any therapy developed by us; and

 

 

any therapy developed by us will not be preferred to any existing or newly-developed technologies.

The commercial potential of our products and product candidates will be significantly limited if we are not able to obtain adequate levels of reimbursement or market acceptance for them.

Our ability to commercialize human therapeutic products and product candidates successfully will depend in part on the extent to which coverage and reimbursement for such products and related treatments will be available from government health administration authorities, private health insurers and other third-party payers or supported by the market for these products. There can be no assurance that third-party payers’ coverage and reimbursement will be available or sufficient for the products we might develop.

Third party payers are increasingly challenging the price of medical products and services and instituting cost containment measures to control or significantly influence the purchase of medical products and services. These cost containment measures, if instituted in a manner affecting the coverage of or payment for our products, could have a material adverse effect on our ability to operate profitably. In some countries in the European Union and in the United States, significant uncertainty exists as to the reimbursement status of newly-approved healthcare products, and we do not know whether adequate third-party coverage and reimbursement will be available for us to realize an appropriate return on our investment in product development, which could seriously harm our business. In the United States, while reimbursement amounts previously approved appear to have provided a reasonable rate of return, there can be no assurance that our products will continue to be reimbursed at current rates or that third-party payers will continue to consider our products cost-effective and provide coverage and reimbursement for our products, in whole or in part.

We cannot be certain that our products will gain commercial acceptance among physicians, patients and third party payers, even if necessary international and United States marketing approvals are maintained. We believe that recommendations and endorsements by physicians will be essential for market acceptance of our products, and we do not know whether these recommendations or endorsements will be obtained. We also believe that surgeons will not use these products unless they determine, based on clinical data and other factors, that the clinical benefits to patients and cost savings achieved through use of these products outweigh their cost. Acceptance among physicians may also depend upon the ability to train surgeons and other potential users of our products and the willingness of such users to learn these relatively new techniques.

Future legislation or regulatory changes to, or consolidation in, the healthcare system may affect our ability to sell our product profitably.

There have been, and we expect there will continue to be, a number of legislative and regulatory proposals to change the healthcare system, and some could involve changes that could significantly affect our business. Efforts by governmental and third-party payers to reduce health care costs or the announcement of legislative proposals or reforms to implement government controls could cause a reduction in sales or in the selling price of our products, which would seriously harm our business. Additionally, initiatives to reduce the cost of healthcare have resulted in a consolidation trend in the healthcare industry, including hospitals. This in turn has resulted in greater pricing pressures and the exclusion of certain suppliers from certain market segments as consolidated groups such as group purchasing organizations, independent delivery networks and large single accounts continue to consolidate purchasing decisions for some of our hospital customers. We expect that market demand, government regulation, and third-party reimbursement policies will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances among our customers and competitors, which may reduce competition, exert further downward pressure on the prices of our products and may adversely impact our business, financial condition or results of operations.

We must receive regulatory approval for each of our product candidates before they can be sold commercially in Canada, the United States or internationally, which can take significant time and be very costly.

The development, manufacture and sale of medical devices and human therapeutic products in Canada, the United States and internationally is governed by a variety of statutes and regulations. These laws require, among other things:

 

 

regulatory approval of manufacturing facilities and practices;

 

 

adequate and well-controlled research and testing of products in pre-clinical and clinical trials;

 

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review and approval of submissions containing manufacturing, pre-clinical and clinical data in order to obtain marketing approval based on establishing the safety and efficacy of the product for each use sought, including adherence to cGMPs during production and storage; and

 

 

control of marketing activities, including advertising and labelling.

The product candidates currently under development by us or our collaborators will require significant research, development, pre-clinical and clinical testing, pre-market review and approval, and investment of significant funds prior to their commercialization. In many instances, we are dependent on our collaborators for regulatory approval and compliance, and have little or no control over these matters. The process of completing clinical testing and obtaining such approvals is likely to take many years and require the expenditure of substantial resources, and we do not know whether any clinical studies by us or our collaborators will be successful, that regulatory approvals will be received, or that regulatory approvals will be obtained in a timely manner. Despite the time and resources expended by us, regulatory approval is never guaranteed. Even if regulatory approval is obtained, regulatory agencies may limit the approval to certain diseases, conditions or categories of patients who can use them.

If any of our development programs are not successfully completed in a timely fashion, required regulatory approvals are not obtained in a timely fashion, or products for which approvals are obtained are not commercially successful, it could seriously harm our business.

Our products and manufacturing facilities that have, or may receive, regulatory approval, are or will be subject to ongoing regulation. In addition, we have little or no control over the manufacturing facilities of our collaborators in which certain of our products are manufactured.

Our products and manufacturing operations are subject to extensive regulation in the United States by the FDA and by similar regulatory agencies abroad. Ongoing regulation includes compliance with an array of manufacturing and design controls and testing, quality control, storage and documentation procedures. Regulatory agencies may also require expensive post-approval studies. Any adverse events associated with our products must also be reported to regulatory authorities. If deficiencies in our or our collaborators’ manufacturing and laboratory facilities are discovered, or we or our collaborators fail to comply with applicable post-market regulatory requirements, a regulatory agency may close the facility or suspend manufacturing.

With respect to products manufactured by third-party contractors, we are, and we expect to continue to be, dependent on our collaborators for continuing regulatory compliance and we may have little or no control over these matters. Our ability to control third-party compliance with FDA and other regulatory requirements will be limited to contractual remedies and rights of inspection. Our failure or the failure of third-party manufacturers to comply with regulatory requirements applicable to our products may result in legal or regulatory action by those regulatory authorities. There can be no assurance that our or our collaborators’ manufacturing processes will satisfy regulatory, cGMP or International Standards Organization (“ISO”) requirements.

In addition, there may be uncertainty as to whether or not we or others who are involved in the manufacturing process will be able to make the transition to commercial production of some of our newly developed products. A failure to achieve regulatory approval for manufacturing facilities or a failure to make the transition to commercial production for our products will adversely affect our prospects, business, financial condition and results of operations.

If we are unable to fully comply with federal and state “fraud and abuse laws”, we could face substantial penalties, which may adversely affect our business, financial condition and results of operations.

We are subject to various laws pertaining to health care fraud and abuse, including the federal Anti-Kickback Statute, physician self-referral laws, the federal False Claims Act, the federal Health Insurance Portability and Accountability Act of 1996, the federal False Statements Statute, and state law equivalents to these federal laws, which may not be limited to government-reimbursed items and may not contain identical exceptions. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, civil and criminal penalties, damages, fines, exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid, and the curtailment or restructuring of operations. Any action against us for violation of these laws could have a significant impact on our business. In addition, we are subject to the U.S. Foreign Corrupt Practices Act. Any action against us for violation by us or our agents or distributors of this act could have a significant impact on our business.

 

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We may be unsuccessful in marketing, selling and distributing certain of our products.

We distribute a number of our products worldwide. In order to achieve commercial success for our approved products, we have established our sales and marketing force in the United States, Europe and other parts of the world. If our distribution personnel or methods are not sufficient to ensure we have supply to meet demand for our products or if there is a quality control failure with our products, it could harm our prospects, business, financial condition and results of operations.

To the extent that we enter into co-promotion or other marketing and sales arrangements with other companies, any revenues received will be dependent on the efforts of others, and we do not know whether these efforts will be successful. Failure to develop a direct sales and marketing force or enter into appropriate arrangements with other companies to market and sell our products will reduce our ability to generate revenues.

Consolidation in the healthcare industry could have an adverse effect on our revenues and results of operations.

Many healthcare industry companies, including medical device companies, are consolidating to create new companies with greater market power. As the healthcare industry consolidates, competition to provide goods and services to industry participants will become more intense. These industry participants may try to use their market power to negotiate price concessions or reductions for medical devices that incorporate components produced by us. If we are forced to reduce our prices because of consolidation in the healthcare industry, our revenues would decrease and our consolidated earnings, financial condition or cash flows would suffer.

We may incur losses associated with foreign currency fluctuations.

We report our operating results and financial position in U.S. dollars in order to more accurately represent the currency of the economic environment in which we operate.

Our operations are in some instances conducted in currencies other than the U.S. dollar and fluctuations in the value of foreign currencies relative to the U.S. dollar could cause us to incur currency exchange losses. In addition to the U.S. dollar, we currently conduct operations in Canadian dollars, Euros, Swiss francs, Danish kroner, and U.K. pounds sterling. Exchange rate fluctuations may reduce our future operating results and comprehensive income. For a description of the effects of exchange rate fluctuations on our results, see “Quantitative and Qualitative Disclosures about Market Risk” in this Quarterly Report on Form 10-Q.

We have not entered into any forward currency contracts or other financial derivatives to hedge foreign exchange risk, and therefore we are subject to foreign currency transaction and translation gains and losses. We purchase goods and services in U.S. and Canadian dollars, Euros, Swiss francs, Danish kroner, and U.K. pounds sterling, and earn a significant portion of our license and milestone revenues in U.S. dollars. Foreign exchange risk is managed primarily by satisfying foreign denominated expenditures with cash flows or assets denominated in the same currency.

Acquisition of companies or technologies may result in disruptions to our business.

As part of our business strategy, we may acquire additional assets and businesses principally relating to or complementary to our current operations. Any acquisitions or mergers by us will be accompanied by the risks commonly encountered in acquisitions of companies. These risks include, among other things, higher than anticipated acquisition costs and expenses, the difficulty and expense of integrating the operations and personnel of the companies and the loss of key employees and customers as a result of changes in management.

In addition, geographic distances may make integration of acquired businesses more difficult. We may not be successful in overcoming these risks or any other problems encountered in connection with any acquisitions.

If significant acquisitions are made for cash consideration, we may be required to use a substantial portion of our available cash, cash equivalents and short-term investments. Future acquisitions by us may cause large one-time expenses or create goodwill or other intangible assets that could result in significant asset impairment charges in the future. Acquisition financing may not be available on acceptable terms, if at all.

 

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If we fail to hire and retain key management, scientific and technical personnel, we may be unable to successfully implement our business plan.

We are highly dependent on our senior management and scientific and technical personnel. The competition for qualified personnel in the healthcare field is intense, and we rely heavily on our ability to attract and retain qualified managerial, scientific and technical personnel. Our ability to manage growth effectively will require continued implementation and improvement of our management systems and the ability to recruit and train new employees. We may not be able to successfully attract and retain skilled and experienced personnel, which could harm our ability to develop our product candidates and generate revenues.

Risks Relating to our Indebtedness, Shares, and Organization and Structure

Our existing and future permitted debt could adversely affect our operations and we may need to restructure our existing debt to ensure that our cash flows are adequate to service our debt.

As described elsewhere in this Quarterly Report on Form 10-Q, we have a significant amount of debt outstanding, the majority of which is guaranteed by our subsidiaries. The Floating Rate Notes, the Subordinated Notes and our revolving credit facility are guaranteed by certain of our subsidiaries.

The amount and terms of our indebtedness and other financial obligations have adversely affected our operations. For example, it:

 

 

increases our vulnerability to general adverse economic and industry conditions;

 

 

limits our ability to obtain additional financing in the future for working capital, capital expenditures, acquisitions, general corporate purposes or other purposes;

 

 

requires us to dedicate a substantial portion of our cash flow from operations to the payment of principal and interest on our indebtedness, thereby reducing the funds available to us for operations and any future business opportunities, including acquisitions permitted by our Subordinated Notes and Floating Rate Notes;

 

 

limits our planning flexibility for, or ability to react to, changes in our business and the industry as discussed under “Management’s Discussion and Analysis of Financial Condition and Results of Operations –Business Overview “ in this Quarterly Report on Form 10-Q; and

 

 

places us at a competitive disadvantage with competitors who may have less indebtedness and other obligations or greater access to financing.

The Floating Rate Notes bear interest at rates that fluctuate with changes in certain prevailing benchmarks. If interest rates increase, we may be unable to meet our debt service obligations under the Floating Rate Notes, the Subordinated Notes, our revolving credit facility and other indebtedness.

As described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations —Liquidity and Capital Resources” in this Quarterly Report on Form 10-Q, we are party to a revolving credit facility in order to provide additional liquidity and capital resources for working capital and general corporate purposes in the near term and more flexibility and time to explore other longer-term options for our overall capital structure and working capital needs. Additionally, we have filed with the SEC a shelf registration statement on Form S-3 that, when declared effective, will enable us to issue and sell up to an aggregate of $250 million of our common shares, Class I Preference shares, debt securities, warrants and/or units in one or more public offerings.

If our cash flows are worse than expected, we may need to refinance or restructure all or a portion of our indebtedness on or before maturity. We cannot assure you that we will be able to repay or refinance any of our debt on commercially reasonable terms or at all. If we are unable to refinance our debt or obtain new financing under these circumstances, we would have to consider other options, such as:

 

 

sales of certain assets to meet our debt service obligations;

 

 

sales of equity; and

 

 

negotiations with our lenders under the revolving credit facility and the holders of our Floating Rate Notes and our Subordinated Notes to restructure the applicable debt.

We may not be able to implement one or more of these alternatives on terms acceptable to us or at all. Our revolving credit facility and the indentures governing our Floating Rate Notes and Subordinated Notes may restrict, or market or business conditions may limit, our ability to do some of these things. Moreover, if we are unable to obtain sufficient financing when we need it or on terms satisfactory to us, our development activities could have to be delayed, curtailed or eliminated and our financial results could be adversely affected.

 

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We and our subsidiaries are permitted to incur substantially more debt, which could further exacerbate the risks associated with our leverage.

The terms of the indentures governing the Floating Rate Notes and Subordinated Notes and our revolving credit facility expressly permit the incurrence of additional amounts of debt for specified purposes. Moreover, neither the indentures governing the Floating Rate Notes and Subordinated Notes nor our revolving credit facility imposes any limitation on our incurrence of liabilities that are not defined as “Indebtedness” under such indentures or facility (such as trade payables). If new debt or other liabilities are added to our and our subsidiaries’ current levels of debt, the related risks that we and they now face could be exacerbated.

If our cash flows prove inadequate to service our debt and provide for our other obligations, we may be required to refinance all or a portion of our existing debt or future debt at terms unfavorable to us.

Our ability to make payments on and refinance our debt, including the Floating Rate Notes, the Subordinated Notes, any borrowings under our revolving credit facility and other financial obligations, and to fund our capital expenditures and acquisitions will depend on our ability to generate substantial operating cash flow. This will depend on our future performance, which will be subject to prevailing economic conditions and to financial, business and other factors beyond our control. Although we have a revolving credit facility in place, if our cash flows are worse than expected, and the amounts we are able to draw on that facility prove inadequate to meet our debt service and other obligations in the future, we may be required to refinance all or a portion of our existing or future debt, including the Floating Rate Notes, the Subordinated Notes or our revolving credit facility, on or before maturity, to sell assets or to obtain additional financing. We cannot assure you that we will be able to refinance any of our indebtedness, including the Floating Rate Notes, the Subordinated Notes or the revolving credit facility, sell any such assets or obtain such additional financing on commercially reasonable terms or at all. Additionally, because the indentures governing the Floating Rate Notes and Subordinated Notes require that, upon the occurrence of a “change of control,” as defined in the indentures, we must make an offer to repurchase the Floating Rate Notes and Subordinated Notes, respectively, at a price equal to 101% of the principal amount thereof, plus accrued and unpaid interest, if any, to the date of repurchase. The occurrence of a “change of control,” as defined in our revolving credit facility, would constitute an event of default and would permit the lenders to terminate their commitments and accelerate any outstanding borrowings under the facility. Thus, in the event that we were required to repurchase the Floating Rate Notes and Subordinated Notes pursuant to our offer, we would not have enough cash available to make such repurchase.

For additional risks related to the refinancing of our existing debt, see “—Our existing and future permitted debt could adversely affect our operations, and we need to restructure our existing debt to ensure that our cash flows are adequate to service our debt.”

The indentures governing the Floating Rate Notes and Subordinated Notes and our revolving credit facility contain covenants that may limit our ability to take advantage of certain business opportunities advantageous to us that may arise.

The indentures governing the Floating Rate Notes and Subordinated Notes and our revolving credit facility contain certain covenants that, among other things, limit our ability and the ability of certain of our subsidiaries to:

 

 

incur, assume or guarantee additional indebtedness or issue preferred stock;

 

 

pay dividends or make other equity distributions to our shareholders;

 

 

purchase or redeem our capital stock;

 

 

make certain investments;

 

 

create liens;

 

 

sell or otherwise dispose of assets;

 

 

engage in transactions with our affiliates; and

 

 

merge or consolidate with another entity or transfer all or substantially all of our assets.

These restrictions could limit our ability to obtain future financing, make acquisitions or needed capital expenditures, withstand economic downturns in our business, industry or the economy in general, conduct operations or otherwise take advantage of business opportunities that may arise.

 

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Although the indentures for the Floating Rate Notes and Subordinated Notes and our revolving credit facility contain fixed charge coverage test that limit our ability to incur indebtedness, these limitation are subject to a number of significant exceptions and qualifications. Moreover, neither of the indentures nor our revolving credit facility imposes any limitation on our incurrence of liabilities that are not considered “Indebtedness” under the indentures (such as operating leases), nor do the indentures impose any limitation on the amount of liabilities incurred by subsidiaries, if any, that might be designated as “Unrestricted Subsidiaries” under the indentures. Despite current indebtedness levels, we and our subsidiaries may still be able to incur substantially more debt. This could further exacerbate the risks associated with our leverage. Also, although the indentures and our revolving credit facility limit our ability to make restricted payments, these restrictions are subject to significant exceptions and qualifications.

The current global credit and financial market conditions may exacerbate certain risks affecting our business.

Sales of our products are dependent, in large part, on reimbursement from government health administration authorities, private health insurers, distribution partners and other organizations. As a result of the current global credit and financial market conditions, these organizations may be unable to satisfy their reimbursement obligations or may delay payment. In addition, federal and state health authorities may reduce Medicare and Medicaid reimbursements, and private insurers may increase their scrutiny of claims. A reduction in the availability or extent of reimbursement could negatively affect our product sales and revenue.

Due to the recent tightening of global credit, there may be a disruption or delay in the performance of our third-party contractors, suppliers or collaborators. We rely on third parties for several important aspects of our business, including royalty revenue, portions of our product manufacturing, clinical development of future collaboration products, conduct of clinical trials and raw materials. If such third parties are unable to satisfy their commitments to us, our business would be adversely affected.

Certain of our products are used in elective medical procedures which are not covered by insurance. Adverse changes in the economy or other conditions or events have had and may continue to have an adverse effect on consumer spending and may reduce the demand for these procedures. Any such changes, conditions or events could have an adverse effect on our sales and results of operations.

The NASDAQ and/or the Toronto Stock Exchange may delist our common shares from quotation on its exchange, which could limit investors’ ability to make transactions in our common shares and subject us to additional trading restrictions.

The NASDAQ rules provide that the exchange can delist a company’s shares for failing to maintain a share price above a dollar. Our common shares have traded in the past at less than a dollar on the NASDAQ. We cannot assure you that we will continue to meet the listing requirements of the NASDAQ or that our common shares will continue to be traded on the NASDAQ in the future.

The Toronto Stock Exchange may delist a company’s shares if, in the opinion of the Toronto Stock Exchange, the financial condition and/or the operating results of the company appear to be unsatisfactory or appear not to warrant continuation of the securities on the trading list. The Toronto Stock Exchange may consider a number of factors when determining whether to delist a company’s shares, including the company’s ability to meet its obligations as they become due, working capital position, quick asset position, total assets, capitalization, cash flow, earnings, annual revenues, public distribution of the listed shares, share price and trading activity. We cannot assure you that we will continue to meet the listing requirements of the Toronto Stock Exchange or that our common shares will continue to be traded on the Toronto Stock Exchange in the future.

The threat of delisting and/or a delisting of our common shares could have material adverse effects by, among other things:

 

 

reducing the liquidity and market price of our common shares;

 

 

reducing the number of investors willing to hold or acquire our common shares, thereby further restricting our ability to obtain equity financing;

 

 

reducing the amount of news and analyst coverage of our company; and

 

 

reducing our ability to retain, attract and motivate our directors, officers and employees.

United States investors may not be able to obtain enforcement of civil liabilities against us.

We were formed under the laws of British Columbia, Canada. A substantial portion of our assets are located outside the United States. In addition, a majority of the members of our board of directors and our officers are residents of countries other than the United States. As a result, it may be impossible for United States investors to affect service of process within the United States upon us or these persons or to enforce against us or these persons any judgments in civil and commercial matters, including judgments under United States federal or state securities laws. In addition, a Canadian court may not permit United States investors to bring an original action in Canada or to enforce in Canada a judgment of a state or federal court in the United States.

 

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Laws and provisions in our notice of articles, articles, shareholder rights plan and stock option plan could delay or deter a change in control.

Our notice of articles and articles allow for the issuance of Class I Preference shares. The board of directors may set the rights and restrictions of any series of preference shares in its sole discretion without the approval of the holders of our common shares. The rights and restrictions of our preference shares may be superior to those of the common shares. Accordingly, the issuance of preference shares also could have the effect of delaying or preventing a change of control of our company. There are at present, no preference shares outstanding.

In addition, under the Business Corporations Act (British Columbia) and our articles, some business combinations, including the sale, lease or other disposition of all or substantially all of our undertaking, must be approved by at least three-quarters of the votes cast by our shareholders in aggregate or, in some cases, approved by at least three-quarters of the votes cast by holders of each class of shares. In some cases, a business combination must be approved by a court. Shareholders may also have a right to dissent from the transaction, in which case, we would be required to pay dissenting shareholders the fair value of their common shares provided they have followed the required procedures.

In addition, our shareholders adopted a shareholder rights plan which provides for substantial dilution to an acquirer of 20% or more of our common shares, except in certain circumstances, including a) the acquirer makes a bid to all shareholders, which, among other things, is held open for at least 60 days and is accepted by independent shareholders holding at least 50% of the outstanding common shares, or b) the bid is otherwise approved by our board of directors. The shareholder rights plan must be reconfirmed by the shareholders every three years.

Furthermore, all of our executive officers have contractual rights under employment agreements that provide for 12 to 24 months severance pay in the event of a change of control of our company. Under our stock option plan, following a change of control, all outstanding stock options vest immediately. In the event that an offer is made to our shareholders generally or to a class of our shareholders, that if accepted would result in the offeror becoming a control person (generally meaning a person holding 20% or more of a company’s voting shares), our board of directors has the discretion under our stock option plan to determine to accelerate the vesting and expiry date of all outstanding options.

Limitations on the ability to acquire and hold our common shares may be imposed by the Competition Act (Canada). This legislation permits the Commissioner of Competition to review any acquisition of a significant interest in our company so long as our assets are valued above certain thresholds. This legislation grants the Commissioner jurisdiction to challenge such an acquisition before the Competition Tribunal if the Commissioner believes that it would, or would be likely to, result in a substantial lessening or prevention of competition in any market in Canada. A reviewable acquisition may not proceed unless the relevant minister is satisfied or is deemed to be satisfied that there is likely to be a net benefit to Canada from the transaction.

Each of these matters could delay or deter a change in control that would be attractive to, and provide liquidity for, shareholders, and could limit the price that investors are willing to pay in the future for our common shares.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

 

Item 3. Defaults Upon Senior Securities

None.

 

Item 4. Submission of Matters to a Vote of Security Holders

(a) On June 4, 2009, we held our 2009 annual general meeting of shareholders.

(b) Proxies were solicited by our management pursuant to Regulation 14A under the Exchange Act. Those directors nominated (Proposal 1) in the proxy statement are shown under (c) below. There was no solicitation opposing management’s nominees for directors and all such nominees were elected pursuant to the vote of the shareholders.

(c) Those matters voted upon and the results were as follows:

(1) Fixing the size of the Board of Directors at six and the election of directors (Proposal 1); and

(2) Appointment of auditors for the ensuing year and the authorization of the directors to fix the remuneration to be paid to the auditors (Proposal 2).

 

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Proposal

   For    Against    Withheld    Spoiled    Broker
Non-Votes

Proposal 1

   38,497,304    10,563,239    0    —      1

William L. Hunter

   48,372,605    —      687,938    —      1

David T. Howard

   37,984,105    —      11,076,438    —      1

Edward M. Brown

   47,845,486    —      1,215,057    —      1

Arthur H. Willms

   37,972,567    —      11,087,976    —      1

Laura Brege

   48,361,448    —      699,095    —      1

Henry A. McKinnell Jr.

   48,340,053    —      720,490    —      1

Proposal 2

   48,504,958    —      555,586    —      —  

 

Item 5. Other Information

RATIO OF EARNINGS TO FIXED CHARGES

The following table sets forth our ratios of earnings to fixed charges for the periods indicated. In computing the ratios of earnings to fixed charges, earnings consist of income from continuing operations before income taxes plus fixed charges. Fixed charges include interest expense and amortization of capitalized expenses related to indebtedness and the portion of lease rental expense representative of interest. We estimate the interest component of lease rental expense to be one-third of lease rental expense.

 

     Year Ended December 31,
(in Thousands)
    Three
Months
Ended
June 30,
    Six
Months
Ended
June 30,
     2004    2005    2006    2007     2008     2009     2009

Ratio of Earnings to Fixed Charges

   116.8    82.9    1.6      —   (1)      —   (1)      —   (1)    1.3

Deficiency of Earnings Available to Cover Fixed Charges

   —      —      —      $ (70,592   $ (754,068   $ (12,094   —  

Ratio of Combined Fixed Charges and Preferred Share Dividends to Earnings

   116.8    82.9    1.6      —   (1)      —   (1)      —   (1)    1.3

Deficiency of Earnings Available to Cover Combined Fixed Charges and Preferred Share Dividends

   —      —      —      $ (70,592   $ (754,068   $ (12,094   —  

 

(1) Our earnings during this period were insufficient to cover fixed charges and, accordingly, ratios are not presented.

 

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Item 6. Exhibits

The following Exhibits are filed as a part of this report:

 

Exhibit

Number

  

Description

  3.1    First Amendment to Credit Agreement, dated as of May 29, 2009, by and among Angiotech, as Parent, the subsidiaries of Parent listed as borrowers on the signature pages thereto, as borrowers, the lenders signatory thereto, as lenders, and Wells Fargo Foothill, LLC, as arranger and administrative agent (incorporated by reference to Exhibit 10.1 to Angiotech’s Current Report on Form 8-K filed June 3, 2009)
31.1    Certification of CEO Pursuant to Securities Exchange Act Rules 13a-14 and 15d-14 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2    Certification of CFO Pursuant to Securities Exchange Act Rules 13a-14 and 15d-14 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1    Certification of CEO and CFO Pursuant to 18 U.S.C. Section 1350 as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  Angiotech Pharmaceuticals, Inc.
Date: August 7, 2009   By:  

/s/ K. Thomas Bailey

   

K. Thomas Bailey

(Principal Financial Officer and Duly Authorized Officer)

 

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