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EX-32.1 - EXHIBIT 32.1 - NOVELION THERAPEUTICS INC.c23808exv32w1.htm
EX-31.1 - EXHIBIT 31.1 - NOVELION THERAPEUTICS INC.c23808exv31w1.htm
EX-31.2 - EXHIBIT 31.2 - NOVELION THERAPEUTICS INC.c23808exv31w2.htm
EX-32.2 - EXHIBIT 32.2 - NOVELION THERAPEUTICS INC.c23808exv32w2.htm
Table of Contents

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended September 30, 2011
OR
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File No. 0-17082
QLT INC.
(Exact name of registrant as specified in its charter)
     
British Columbia, Canada   N/A
     
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)
     
101 — 887 Great Northern Way, Vancouver, B.C., Canada   V5T 4T5
     
(Address of principal executive offices)   (Zip code)
Registrant’s telephone number, including area code: (604) 707-7000
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o
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 during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No o
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 definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
             
Large accelerated filer o   Accelerated filer þ   Non-accelerated filer o   Smaller reporting company o
        (Do not check if a smaller reporting company)    
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
As of November 1, 2011, the registrant had 49,363,310 outstanding shares of common stock.
 
 

 

 


 

QLT INC.
QUARTERLY REPORT ON FORM 10-Q
September 30, 2011
TABLE OF CONTENTS
         
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 Exhibit 31.1
 Exhibit 31.2
 Exhibit 32.1
 Exhibit 32.2

 

 


Table of Contents

PART I — FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
QLT Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
                 
(In thousands of U.S. dollars)   September 30, 2011     December 31, 2010  
 
               
ASSETS
               
Current assets
               
Cash and cash equivalents
  $ 203,955     $ 209,478  
Accounts receivable
    10,244       10,720  
Current portion of contingent consideration (Notes 9 and 11)
    37,908       36,520  
Inventories (Note 2)
    2,681       3,324  
Current portion of deferred income tax assets
    1,557       3,643  
Current portion of mortgage receivable (Note 3)
    5,713       2,004  
Prepaid and other
    2,043       2,958  
 
           
 
    264,101       268,647  
 
               
Property, plant and equipment
    4,024       3,035  
Deferred income tax assets
    1,550       2,700  
Mortgage receivable (Note 3)
          6,013  
Long-term inventories and other assets (Note 4)
    12,233       13,319  
Contingent consideration (Notes 9 and 11)
    70,966       94,069  
 
           
 
  $ 352,874     $ 387,783  
 
           
 
               
LIABILITIES
               
Current liabilities
               
Accounts payable
  $ 5,652     $ 6,031  
Income taxes payable
    11       716  
Accrued liabilities (Note 5)
    7,363       6,323  
Deferred income tax liability
    82       82  
 
           
 
    13,108       13,152  
 
               
Uncertain tax position liabilities
    1,664       1,687  
 
           
 
    14,772       14,839  
 
           
 
               
SHAREHOLDERS’ EQUITY
               
Share capital (Note 7)
               
Authorized
               
500,000,000 common shares without par value
               
5,000,000 first preference shares without par value, issuable in series
               
Issued and outstanding
               
Common shares
    462,429       479,998  
September 30, 2011 — 49,363,310 shares
               
December 31, 2010 — 51,154,392 shares
               
Additional paid-in capital
    294,173       287,646  
Accumulated deficit
    (521,469 )     (497,669 )
Accumulated other comprehensive income
    102,969       102,969  
 
           
 
    338,102       372,944  
 
           
 
  $ 352,874     $ 387,783  
 
           
See the accompanying Notes to the Unaudited Condensed Consolidated Financial Statements.

 

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QLT Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars except share and per share information)   2011     2010     2011     2010  
 
                               
Revenues
                               
Net product revenue (Note 8)
  $ 6,226     $ 5,535     $ 20,724     $ 24,786  
Royalties
    3,355       3,050       10,441       9,891  
 
                       
 
    9,581       8,585       31,165       34,677  
 
                       
 
                               
Costs and expenses
                               
Cost of sales
    2,673       1,869       7,422       11,813  
Research and development
    11,282       8,101       32,334       22,776  
Selling, general and administrative
    5,842       5,354       19,198       15,238  
Depreciation
    328       306       1,040       922  
 
                       
 
    20,125       15,630       59,994       50,749  
 
                       
 
                               
Operating loss
    (10,544 )     (7,045 )     (28,829 )     (16,072 )
 
                               
Investment and other income
                               
Net foreign exchange (losses) gains
    (298 )     409       39       78  
Interest income
    146       602       534       1,599  
Fair value change in contingent consideration (Note 11)
    1,828       5,206       6,864       10,167  
Other gains
    9       24       18       392  
 
                       
 
    1,685       6,241       7,455       12,236  
 
                       
 
                               
Loss before income taxes
    (8,859 )     (804 )     (21,374 )     (3,836 )
 
                               
(Provision for) recovery of income taxes (Note 10)
    (247 )     107       (2,426 )     5,527  
 
                       
 
                               
Net (loss) income
  $ (9,106 )   $ (697 )   $ (23,800 )   $ 1,691  
 
                       
 
                               
Basic and diluted net (loss) income per common share
  $ (0.18 )   $ (0.01 )   $ (0.47 )   $ 0.03  
 
                               
Weighted average number of common shares outstanding (thousands)
                               
Basic
    49,732       51,656       50,425       52,794  
Diluted
    49,732       51,656       50,425       53,789  
See the accompanying Notes to the Unaudited Condensed Consolidated Financial Statements.

 

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QLT Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars)   2011     2010     2011     2010  
 
                               
Cash (used in) generated by operating activities
                               
Net (loss) income
  $ (9,106 )   $ (697 )   $ (23,800 )   $ 1,691  
Adjustments to reconcile net (loss) income to net cash used in operating activities
                               
Depreciation
    328       306       1,040       922  
Gain on sales of long-lived assets
    (8 )           (17 )     (317 )
Share-based compensation
    690       618       2,283       1,872  
Unrealized foreign exchange gains (losses)
    206       (425 )     102       (113 )
Interest earned on note receivable
          (250 )           (741 )
Deferred income taxes
    395       942       3,276       (4,337 )
Changes in non-cash operating assets and liabilities
                               
Accounts receivable
    3,101       3,952       815       270  
Inventories
    309       273       1,323       757  
Long-term deposits and other assets
    319       592       1,365       4,569  
Accounts payable
    476       383       (256 )     73  
Income taxes receivable / payable
    1,945       6,027       (940 )     5,951  
Other accrued liabilities
    881       684       401       12  
Deferred revenue
                      (4,244 )
 
                       
 
    (464 )     12,405       (14,408 )     6,365  
 
                       
 
                               
Cash provided by investing activities
                               
Net proceeds from sale of property, plant and equipment
    8             17        
Purchase of property, plant and equipment
    (530 )     (231 )     (2,069 )     (1,430 )
Net proceeds from sale of long-lived assets
                      317  
Proceeds from mortgage receivable
          3,822       2,004       3,822  
Proceeds from contingent consideration(1)
    8,192       4,321       21,715       17,644  
 
                       
 
    7,670       7,912       21,667       20,353  
 
                       
 
                               
Cash used in financing activities
                               
Common shares repurchased, including fees
    (4,155 )     (8,668 )     (14,583 )     (17,082 )
Issuance of common shares
    66       490       1,838       763  
 
                       
 
    (4,089 )     (8,178 )     (12,745 )     (16,319 )
 
                       
 
                               
Effect of exchange rate changes on cash and cash equivalents
    (262 )     152       (37 )     71  
 
                       
 
                               
Net increase (decrease) in cash and cash equivalents
    2,855       12,291       (5,523 )     10,470  
Cash and cash equivalents, beginning of period
    201,100       186,293       209,478       188,114  
 
                       
 
                               
Cash and cash equivalents, end of period
  $ 203,955     $ 198,584     $ 203,955     $ 198,584  
 
                       
 
                               
Supplementary cash flow information:
                               
 
                               
Interest paid
  $     $     $     $  
Income taxes paid
    2             938       10  
(1)  
On October 1, 2009, all of the shares of QLT USA, Inc. (“QLT USA”) were sold to TOLMAR Holding, Inc. (“Tolmar”) for up to an aggregate $230.0 million, plus cash on hand of $118.3 million. The purchase price included contingent consideration of $200.0 million which had a fair value of $156.2 million on October 1, 2009, representing a non-cash investing activity.
 
   
During the three months ended September 30, 2011, proceeds received on collection of the contingent consideration totalled $10.0 million (2010 — $9.5 million). Approximately $8.2 million (2010 — $4.3 million) of the proceeds were included within cash provided by investing activities. The remaining $1.8 million (2010 — $5.2 million) of the proceeds were recorded in the Statement of Operations as the fair value change in contingent consideration and were therefore reflected in the net (loss) income line item within cash used in operating activities.
 
   
During the nine months ended September 30, 2011, proceeds received on collection of the contingent consideration totalled $28.6 million (2010 — $27.8 million). Approximately $21.7 million (2010 — $17.6 million) of the proceeds were included within cash provided by investing activities. The remaining $6.9 million (2010 — $10.2 million) of the proceeds were recorded in the Statement of Operations as the fair value change in contingent consideration and were therefore reflected in the net (loss) income line item within cash used in operating activities.
See the accompanying Notes to the Unaudited Condensed Consolidated Financial Statements.

 

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QLT Inc.
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY
(Unaudited)
                                                         
                            Accumulated                        
share information are expressed in                   Additional     Other                     Total  
share information are expressed in   Common Shares     Paid-in     Comprehensive     Accumulated     Comprehensive     Shareholders’  
thousands of U.S. dollars)   Shares     Amount     Capital     Income     Deficit     Loss     Equity  
 
                                                       
Balance at January 1, 2010
    53,789,289     $ 506,023     $ 275,592     $ 102,969     $ (480,130 )   $     $ 404,454  
Exercise of stock options, for cash, at prices ranging from CAD $2.44 to CAD $6.27 per share
    265,585       1,243       (333 )                       910  
Stock-based compensation
                2,365                         2,365  
Common share repurchase
    (2,900,482 )     (27,268 )     10,022                         (17,246 )
Net loss
                            (17,539 )     (17,539 )     (17,539 )
 
                                                     
Comprehensive loss
                                  (17,539 )      
 
                                         
Balance at December 31, 2010
    51,154,392     $ 479,998     $ 287,646     $ 102,969     $ (497,669 )   $     $ 372,944  
Exercise of stock options, for cash, at prices ranging from CAD $2.44 to CAD $6.27 per share
    138,883       1,002       (288 )                       714  
Stock-based compensation
                955                         955  
Common share repurchase
    (533,500 )     (5,006 )     1,331                         (3,675 )
Net loss
                            (8,549 )     (8,549 )     (8,549 )
 
                                                     
Comprehensive loss
                                  (8,549 )      
 
                                         
Balance at March 31, 2011
    50,759,775     $ 475,994     $ 289,644     $ 102,969     $ (506,218 )   $     $ 362,389  
Exercise of stock options, for cash, at prices ranging from CAD $2.44 to CAD $6.27 per share
    196,996       1,504       (438 )                       1,066  
Stock-based compensation
                688                         688  
Common share repurchase
    (1,006,572 )     (9,436 )     2,300                         (7,136 )
Net loss
                            (6,145 )     (6,145 )     (6,145 )
 
                                                     
Comprehensive loss
                                  (6,145 )      
 
                                         
Balance at June 30, 2011
    49,950,199     $ 468,062     $ 292,194     $ 102,969     $ (512,363 )   $     $ 350,862  
Exercise of stock options, for cash, at prices ranging from CAD $2.44 to CAD $6.27 per share
    42,556       264       (76 )                       188  
Stock-based compensation
                681                         681  
Common share repurchase
    (629,445 )     (5,897 )     1,374                         (4,523 )
Net loss
                            (9,106 )     (9,106 )     (9,106 )
 
                                                     
Comprehensive loss
                                  (9,106 )      
 
                                         
Balance at September 30, 2011
    49,363,310     $ 462,429     $ 294,173     $ 102,969 (1)   $ (521,469 )   $     $ 338,102  
 
                                         
(1)  
At September 30, 2011 our accumulated other comprehensive income is entirely related to historical cumulative translation adjustments from the application of U.S. dollar reporting when the functional currency of QLT Inc. was the Canadian dollar.
See the accompanying Notes to the Unaudited Condensed Consolidated Financial Statements.

 

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NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Throughout this Quarterly Report on Form 10-Q (this “Report”), the words “we,” “us,” “our,” “the Company” and “QLT” refer to QLT Inc. and its wholly owned subsidiaries, QLT Plug Delivery, Inc., QLT Therapeutics, Inc. and QLT Ophthalmics, Inc., unless stated otherwise.
1. CONDENSED SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Business
QLT is an ocular-focused company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide. We are focused on developing our synthetic retinoid program for the treatment of certain inherited retinal diseases, developing our proprietary punctal plug drug delivery system, as well as U.S. marketing of our commercial product, Visudyne®, for the treatment of wet age related macular degeneration (“wet AMD”).
Basis of Presentation
These unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States and pursuant to the rules and regulations of the United States Securities and Exchange Commission (the “SEC”) for the presentation of interim financial information. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with United States generally accepted accounting principles have been condensed, or omitted, pursuant to such rules and regulations. These financial statements do not include all disclosures required for annual financial statements and should be read in conjunction with our audited consolidated financial statements and notes thereto included as part of our Annual Report on Form 10-K for the year ended December 31, 2010 (our “2010 Annual Report”). All amounts are expressed in United States dollars unless otherwise noted.
In the opinion of management, the condensed consolidated financial statements reflect all adjustments (including reclassifications and normal recurring adjustments) necessary to present fairly the financial position, results of operations and cash flows at September 30, 2011, and for all periods presented. The interim results presented are not necessarily indicative of results that can be expected for a full year.
Principles of Consolidation
These consolidated financial statements include the accounts of QLT and its subsidiaries, all of which are wholly owned. The principal subsidiaries included in our consolidated financial statements are QLT Plug Delivery, Inc., QLT Therapeutics, Inc. and QLT Ophthalmics, Inc., each of which is incorporated in the State of Delaware in the United States of America. All intercompany transactions have been eliminated.
Use of Estimates
The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods presented. Significant estimates are used for, but not limited to, provisions for non-completion of inventory, provision for excess inventory, assessment of the recoverability of long-lived assets, the fair value of the mortgage receivable, the fair value of contingent consideration, allocation of costs to manufacturing under a standard costing system, allocation of overhead expenses to research and development, sales rebates and return accruals, determination of the fair value of assets and liabilities acquired in net asset acquisitions or purchase business combinations, stock-based compensation, provisions for taxes, tax assets and liabilities. Actual results may differ from estimates made by management.
Segment Information
We operate in one industry segment, which is the business of developing, manufacturing, and commercializing opportunities in ophthalmology. Our chief operating decision maker reviews our operating results on an aggregate basis and manages our operations as a single operating segment.
Revenue Recognition
Net Product Revenue
Net product revenue is derived from sales of Visudyne to distributors in the U.S. and to Novartis Pharma AG (“Novartis”) outside the U.S., plus reimbursement of certain costs from Novartis. We recognize revenue from the sale of Visudyne when persuasive evidence of an arrangement exists, delivery has occurred, the end selling price of Visudyne is fixed or determinable, and collectibility is reasonably assured. For U.S. Visudyne sales, provisions for certain vendor charge-backs, discounts, Medicaid rebates, distributor fees and product returns are accounted for as a reduction of revenue in the same period the related revenue is recorded. Rebates, vendor charge-backs, and discounts are estimated based on contractual terms, historical experience, and projected market conditions. Product returns are estimated based on historical experience and business trends. We recognize revenue upon delivery, when title and risk of loss passes to Novartis and other distributors.

 

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Royalties
We recognize royalties when product is sold by Novartis to end customers based on royalty rates specified in the Amended and Restated PDT Product Development, Manufacturing and Distribution Agreement (“Amended PDT Agreement”) with Novartis. Royalties are based on net product sales (gross sales less discounts, allowances and other items) and calculated based on information supplied to us by Novartis.
Income Taxes
Income taxes are reported using the asset and liability method, whereby deferred tax assets and liabilities are recognized for the future tax consequences attributable to: (i) differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and (ii) operating loss and tax credit carry forwards using applicable enacted tax rates. An increase or decrease in these tax rates will increase or decrease the carrying value of future net tax assets resulting in an increase or decrease to net income. Income tax credits, such as investment tax credits, are included as part of the provision for income taxes. The realization of our deferred tax assets is primarily dependent on generating sufficient taxable income prior to expiration of any loss carry forward balance. A valuation allowance is provided when it is more likely than not that a deferred tax asset may not be realized. Changes in valuation allowances are included in our tax provision in the period of change.
Contingent Consideration
Contingent consideration arising from the sale of all of the shares of our then wholly-owned subsidiary, QLT USA, on October 1, 2009 is measured at fair value. The contingent consideration is revalued at each reporting period and changes are included in continuing operations.
Net (Loss) Income Per Common Share
Basic net (loss) income per common share is computed using the weighted average number of common shares outstanding during the period. Diluted net (loss) income per common share is computed in accordance with the treasury stock method, which uses the weighted average number of common shares outstanding during the period and also includes the dilutive effect of potentially issuable common stock from outstanding stock options.
The following table sets out the computation of basic and diluted net (loss) income per common share:
                                 
    Three months ended     Nine months ended  
(In thousands of U.S. dollars, except share and per share   September 30,     September 30,  
data)   2011     2010     2011     2010  
Numerator:
                               
Net (loss) income
  $ (9,106 )   $ (697 )   $ (23,800 )   $ 1,691  
 
                       
Denominator: (thousands)
                               
Weighted average common shares outstanding
    49,732       51,656       50,425       52,794  
Effect of dilutive securities:
                               
Stock options
                      995  
 
                       
Diluted weighted average common shares outstanding
    49,732       51,656       50,425       53,789  
 
                       
 
                               
Basic and diluted net (loss) income per common share
  $ (0.18 )   $ (0.01 )   $ (0.47 )   $ 0.03  
Excluded from the calculation of diluted net loss per common share for the three and nine months ended September 30, 2011 were 6,365,176 shares related to stock options because their effect was anti-dilutive. For the three and nine months ended September 30, 2010, 6,394,907 and 3,564,189 shares, respectively, were excluded from the calculation of diluted net (loss) income per common share because their effect was anti-dilutive.
Fair Value of Financial Assets and Liabilities
The carrying values of cash and cash equivalents, trade receivables and payables, contingent consideration and the mortgage receivable approximate fair value. We estimate the fair value of our financial instruments using the market approach. The fair values of our financial instruments reflect the amounts that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price).

 

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Recently Issued Accounting Standards
In May 2011, the FASB issued ASU 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. ASU No. 2011-04 generally provides a uniform framework for fair value measurements and related disclosures between U.S. GAAP and International Financial Reporting Standards (“IFRS”). Additional disclosure requirements in the update include: (1) for Level 3 fair value measurements, quantitative information about unobservable inputs used, a description of the valuation processes used by the entity, and a qualitative discussion about the sensitivity of the measurements to changes in the unobservable inputs; (2) for an entity’s use of a nonfinancial asset that is different from the asset’s highest and best use, the reason for the difference; (3) for financial instruments not measured at fair value but for which disclosure of fair value is required, the fair value hierarchy level in which the fair value measurements were determined; and (4) the disclosure of all transfers between Level 1 and Level 2 of the fair value hierarchy. ASU 2011-04 will be effective for interim and annual periods beginning on or after December 15, 2011, which for us will be our 2012 first quarter. We are currently evaluating the impact that ASU 2011-04 will have on our financial statements.
In June 2011, the FASB issued ASU 2011-05, Presentation of Comprehensive Income, which amends existing guidance by allowing only two options for presenting the components of net income and other comprehensive income: (1) in a single continuous financial statement, statement of comprehensive income or (2) in two separate but consecutive financial statements, consisting of an income statement followed by a separate statement of other comprehensive income. Also, items that are reclassified from other comprehensive income to net income must be presented on the face of the financial statements. ASU No. 2011-05 requires retrospective application, and it is effective for fiscal years, and interim periods within those years, beginning after December 15, 2011 (for us this will be our 2012 first quarter), with early adoption permitted. We believe the adoption of this update will change the way in which comprehensive income is presented and provide additional detail on the face of certain financial statements when applicable, rather than as disclosed currently. It will not have any other impact on our financial statements.
Recently Adopted Accounting Standards
In October 2009, the FASB issued EITF 08-01, Revenue Arrangements with Multiple Deliverables (currently within the scope of FASB Accounting Standards Codification (ASC) Subtopic 605-25). This statement provides principles for allocation of consideration among its multiple-elements, allowing more flexibility in identifying and accounting for separate deliverables under an arrangement. The EITF introduces an estimated selling price method for valuing the elements of a bundled arrangement if vendor-specific objective evidence or third-party evidence of selling price is not available, and significantly expands related disclosure requirements. This standard is effective on a prospective basis for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Alternatively, adoption may be on a retrospective basis, and early application is permitted. The prospective adoption of this standard on January 1, 2011, did not have a material impact on our financial condition, results of operations or cash flows.
In March 2010, the FASB ratified the EITF final consensus on Issue ASC 2010-17, Milestone Method of Revenue Recognition. The guidance in this consensus allows the milestone method as an acceptable revenue recognition methodology when an arrangement includes substantive milestones. The guidance provides a definition of a substantive milestone and should be applied regardless of whether the arrangement includes single or multiple deliverables or units of accounting. The scope of this consensus is limited to transactions involving milestones relating to research and development deliverables. The guidance includes enhanced disclosure requirements about each arrangement, individual milestones and related contingent consideration, information about substantive milestones and factors considered in the determination. The consensus is effective prospectively to milestones achieved in fiscal years, and interim periods within those years, after June 15, 2010. Early application and retrospective application are permitted. The prospective adoption of this standard on January 1, 2011, did not have a material impact on our financial condition, results of operations or cash flows.
In December 2010, the FASB issued ASU 2010-27, Fees Paid to the Federal Government by Pharmaceutical Manufacturers. ASU 2010-27 provides guidance on the recognition and classification of the annual fee imposed by the Patient Protection and Affordable Care Act as amended by the Health Care and Education Affordability Reconciliation Act on pharmaceutical companies that sell branded prescription drugs or biologics to specified government programs in the United States. Under this guidance, the annual fee should be estimated and recognized in full as a liability upon the first qualifying sale with a corresponding deferred cost that is amortized to operating expense using a straight-line method of allocation unless another method better allocates the fee over the calendar year in which it is payable. The annual fee is not deductible for federal income tax purposes. This guidance became effective for calendar years beginning after December 31, 2010. The prospective adoption of this standard on January 1, 2011, did not have a material impact on our financial condition, results of operations or cash flows.

 

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2. INVENTORIES
                 
(In thousands of U.S. dollars)   September 30, 2011     December 31, 2010  
 
               
Raw materials and supplies
  $ 56     $ 74  
Work-in-process
    26,653       28,045  
Finished goods
    416       274  
Provision for excess inventory
    (11,085 )     (11,077 )
Provision for non-completion of inventory
    (2,185 )     (2,185 )
 
           
 
  $ 13,855     $ 15,131  
Long-term inventory, net of provisions
    (11,174 )     (11,807 )
 
           
Current inventory
  $ 2,681     $ 3,324  
 
           
We review our inventory quantities against our forecast of future demand and market conditions and, if necessary, provide a reserve for potential excess or obsolete inventory. Our provision for excess inventory of $11.1 million as of September 30, 2011, which was applied against our long-term inventory, has been determined based on our forecast of future Visudyne demand.
We record a provision for non-completion of inventory to provide for the potential failure of inventory batches in production to pass quality inspection. During the three and nine months ended September 30, 2011, there were no charges against the provision for non-completion of product inventory.
We classify inventories that we do not expect to convert or consume in the next year as non-current based upon an analysis of market conditions such as sales trends, sales forecasts, sales price, and other factors. See Note 4 — Long-Term Inventories and Other Assets.
3. MORTGAGE RECEIVABLE
Under the terms of the original mortgage agreement, our mortgage receivable was due on August 29, 2010 and comprised a two-year, 6.5% interest-only, second mortgage in the amount of CAD $12.0 million related to the sale of our land and building to Discovery Parks Holdings Ltd., an affiliate of Discovery Parks Trust (“Discovery Parks”) in 2008. Effective August 29, 2010, we entered into an amended mortgage agreement with Discovery Parks, pursuant to which we received payment of CAD $4.0 million on August 30, 2010. The remaining mortgage receivable of CAD $8.0 million comprised a 7.5% interest-only second mortgage, of which CAD $2.0 million was due on or before May 1, 2011, and CAD $6.0 million is due on August 29, 2012. We have received the CAD $2.0 million that was due on or before May 1, 2011.
4. LONG-TERM INVENTORIES AND OTHER ASSETS
                 
(In thousands of U.S. dollars)   September 30, 2011     December 31, 2010  
 
               
Inventory, net of provisions
  $ 11,174     $ 11,807  
Deposits and other
    1,059       1,512  
 
           
 
  $ 12,233     $ 13,319  
 
           
5. ACCRUED LIABILITIES
                 
(In thousands of U.S. dollars)   September 30, 2011     December 31, 2010  
 
               
Royalties
  $ 1,033     $ 1,225  
Compensation
    3,836       3,698  
Directors’ Deferred Share Units compensation
    1,710       1,400  
Other
    784        
 
           
 
  $ 7,363     $ 6,323  
 
           

 

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6. FOREIGN EXCHANGE FACILITY
We have a foreign exchange facility for the sole purpose of entering into foreign exchange contracts. The facility allows us to enter into a maximum of $100.0 million in forward foreign exchange contracts for terms up to 15 months, or in the case of spot foreign exchange transactions, a maximum of $70.0 million. The facility requires security in the form of cash or money market instruments based on the contingent credit exposure for any outstanding foreign exchange transactions. At September 30, 2011, there was no collateral pledged as security for this facility, as we had no outstanding foreign exchange transactions.
7. SHARE CAPITAL
(a) Share Buy-Back Programs
On December 8, 2010, we announced that our Board of Directors authorized the repurchase of up to 3,615,285 of our issued and outstanding common shares, being 10% of our public float as of December 9, 2010, over a 12-month period commencing December 16, 2010 under a normal course issuer bid. All purchases are to be effected in the open market through the facilities of the TSX or NASDAQ, and in accordance with regulatory requirements. The actual number of common shares which are purchased and the timing of such purchases will be determined by management, subject to compliance with applicable law. All common shares repurchased will be cancelled. Cumulative purchases under this program through September 30, 2011, were 2,191,817 shares at an average price of $7.02, for a total cost of $15.4 million.
On October 27, 2009, we announced that our Board of Directors authorized the repurchase of up to 2,731,534 of our common shares, being 5% of our issued and outstanding common shares, over a 12-month period commencing November 3, 2009 under a normal course issuer bid. In May 2010, the normal course issuer bid was increased to repurchase up to 4,700,060 shares, representing 10% of our public float. All purchases under the bid were effected in the open market through the facilities of the NASDAQ, and in accordance with all regulatory requirements. Total purchases under this program were 3,744,972 shares at an average price of $5.59 per share, for a total cost of $20.9 million.
(b) Stock Options
We use the Black-Scholes option pricing model to estimate the value of the options at each grant date, using the following weighted average assumptions (no dividends are assumed):
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
    2011     2010     2011     2010  
Annualized volatility
          55.4 %     48.8 %     53.8 %
Risk-free interest rate
          2.1 %     2.1 %     2.3 %
Expected life (years)
          3.7       3.7       3.7  
The Black-Scholes option pricing model was developed for use in estimating the value of traded options that have no vesting restrictions and are fully transferable. In addition, option pricing models require the input of highly subjective assumptions, including the expected stock price volatility. We project expected volatility and expected life of our stock options based upon historical and other economic data trended into future years. The risk-free interest rate assumption is based upon observed interest rates appropriate for the terms of our stock options.
There were no stock options granted during the three months ended September 30, 2011. The weighted average grant date fair value of stock options granted during the three months ended September 30, 2010 was CAD $2.79. The weighted average grant date fair value of stock options granted during the nine months ended September 30, 2011 and 2010 was CAD $2.79 and CAD $2.61, respectively.

 

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The impact on our results of operations of recording stock-based compensation for the three and nine months ended September 30, 2011 and 2010 was as follows:
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars)   2011     2010     2011     2010  
 
                               
Cost of sales
  $ 58     $ 5     $ 69     $ 158  
Research and development
    369       338       1,100       957  
Selling, general and administrative
    263       275       1,114       757  
 
                       
Stock-based compensation expense before income taxes
    690       618       2,283       1,872  
Related income tax benefits
    (22 )     (13 )     (58 )     (32 )
 
                       
 
                               
Stock-based compensation, net of income taxes
  $ 668     $ 605     $ 2,225     $ 1,840  
 
                       
At September 30, 2011, total unrecognized estimated compensation cost related to non-vested stock options was $4.8 million, which is expected to be recognized over 36 months with a weighted average period of 2.1 years.
The intrinsic value of stock options exercised and the related cash from exercise of stock options during the three and nine months ended September 30, 2011 and 2010 was as follows:
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars)   2011     2010     2011     2010  
 
                               
Intrinsic value of stock options exercised
  $ 113     $ 342     $ 841     $ 558  
Cash from exercise of stock options
  $ 188     $ 490     $ 1,968     $ 763  
Upon option exercise, we issue new shares of stock. The share-based compensation capitalized as part of inventory and the related tax benefits recorded were negligible for all periods presented above.
8. NET PRODUCT REVENUE
Under the terms of the Amended PDT Agreement with Novartis, on January 1, 2010, we received from Novartis the exclusive U.S. rights to the Visudyne patents to sell and market Visudyne in the U.S. In the nine months ended September 30, 2010, $5.0 million of previously deferred revenue related to inventory previously shipped to Novartis for sales outside the U.S. was recognized as revenue. Details of our revenue recognition accounting policy are described in Note 1 — Condensed Summary of Significant Accounting Policies.
Net product revenue for the three and nine months ended September 30, 2011 and 2010, was determined as follows:
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars)   2011     2010     2011     2010  
 
                               
U.S. Visudyne sales by QLT
  $ 3,853     $ 5,218     $ 15,631     $ 16,668  
Visudyne sales to Novartis
    2,026             4,011       6,988  
Add: Royalties reimbursed to QLT
    337       308       1,051       999  
Add: Other costs reimbursed to QLT
    10       9       31       131  
 
                       
Net product revenue from Visudyne sales
  $ 6,226     $ 5,535     $ 20,724     $ 24,786  
 
                       

 

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The tables below summarize end-user Visudyne sales for the three and nine months ended September 30, 2011 and 2010. Under the Amended PDT Agreement with Novartis, Visudyne is sold by QLT in the U.S., and by Novartis outside the U.S. (for which we earn a 20% royalty on net sales). See Note 1 - Condensed Summary of Significant Accounting Policies.
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars)   2011     2010     2011     2010  
 
                               
U.S.
  $ 3,853     $ 5,218     $ 15,631     $ 16,668  
Europe
    5,729       5,303       19,856       19,447  
Rest of World
    11,044       9,945       32,350       30,010  
 
                       
Worldwide
  $ 20,626     $ 20,466     $ 67,837     $ 66,125  
 
                       
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
    2011     2010     2011     2010  
 
                               
U.S.
    19 %     25 %     23 %     25 %
Europe
    28 %     26 %     29 %     29 %
Rest of World
    53 %     49 %     48 %     46 %
 
                       
Worldwide
    100 %     100 %     100 %     100 %
 
                       
9. CONTINGENT CONSIDERATION
On October 1, 2009, we divested the Eligard® product line as part of the sale of all of the shares of our U.S. subsidiary, QLT USA, to Tolmar for up to an aggregate $230.0 million plus cash on hand of $118.3 million. Pursuant to the stock purchase agreement, we received $20.0 million on closing and $10.0 million on October 1, 2010 and expect to receive up to an additional $200.0 million payable on a quarterly basis in amounts equal to 80% of the royalties paid under the license agreement with Sanofi Synthelabo Inc. (“Sanofi”) for the commercial marketing of Eligard in the U.S. and Canada, and the license agreement with MediGene Aktiengesellschaft (“MediGene”) which, effective March 1, 2011, has been assigned to Astellas Pharma Europe Ltd. (“Astellas”) for the commercial marketing of Eligard in Europe. The estimated fair value of these expected future quarterly payments is reflected as Contingent Consideration on our Condensed Consolidated Balance Sheet. We are entitled to these payments until the earlier of our receipt of the additional $200.0 million or October 1, 2024. As of September 30, 2011, we had received an aggregate $74.0 million of contingent consideration. We expect to receive the remaining $126.0 million on a quarterly basis, over the next three to four years. The contingent consideration payments are not generated from a migration or continuation of activities and therefore are not direct cash flows of the divested business. We have not had any continuing involvement with this business following its sale. See Note 11 — Financial Instruments and Concentration of Credit Risk.
10. INCOME TAXES
The change in the effective tax rate was primarily due to changes in the overall mix of income (loss) in the jurisdictions in which we operate, including changes in our valuation allowance in such jurisdictions. In 2010, we completed an intra-entity transfer of intellectual property and, as a result, shifted certain related future development expenditures to the acquiring entity. During 2011, as insufficient evidence exists to support current or future realization of the tax benefits associated with such development expenditures as well as certain other current period expenditures, the benefit of certain tax assets has not been recognized in the current periods. The tax recovery for the nine months ended September 30, 2010 reflected a benefit of $5.6 million which was recorded as a result of the restructuring of our arrangement with Novartis under the Amended PDT Agreement.
11. FINANCIAL INSTRUMENTS AND CONCENTRATION OF CREDIT RISK
We have various financial instruments that must be measured under the fair value standard including cash and cash equivalents, the mortgage receivable and, from time to time, forward currency contracts. The mortgage owed to us is recorded as a receivable and is carried at amortized cost. Based on market information, the book value of our mortgage receivable approximates fair value. Our financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy.

 

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The following table provides information about our assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2011 and indicates the fair value hierarchy of the valuation techniques we utilized to determine such fair value:
                                 
    Carrying Value     Fair Value Measurements at September 30, 2011  
(In thousands of U.S. dollars)   September 30, 2011     Level 1     Level 2     Level 3  
Assets:
                               
Cash and cash equivalents
  $ 203,955     $ 203,955     $     $  
Contingent consideration(1)
    108,874                   108,874  
 
                       
Total
  $ 312,829     $ 203,955     $     $ 108,874  
 
                       
(1)  
To estimate the fair value of contingent consideration at September 30, 2011, we used a discounted cash flow model based on estimated timing and amount of future cash flows, discounted using a cost of capital of 10% determined by management after considering available market and industry information. Future cash flows were estimated by utilizing external market research to estimate market size, to which we applied market share, pricing, and foreign exchange assumptions based on historical sales data, expected future competition and current exchange rates. If the discount rate were to increase by 1%, the contingent consideration would decrease by $1.5 million, from $108.9 million to $107.4 million. If estimated future revenues were to decrease by 10%, the contingent consideration would decrease by $1.7 million, from $108.9 million to $107.2 million.
The following table represents a reconciliation of our asset (contingent consideration) measured and recorded at fair value on a recurring basis, using significant unobservable inputs (Level 3):
         
(In thousands of U.S. dollars)   Level 3  
Balance at January 1, 2010
  $ 151,078  
Transfers to Level 3
     
Settlements
    (36,982 )
Fair value change in contingent consideration
    16,493  
 
     
Balance at December 31, 2010
  $ 130,589  
Transfers to Level 3
     
Settlements
    (11,172 )
Fair value change in contingent consideration
    2,282  
 
     
Balance at March 31, 2011
  $ 121,699  
Transfers to Level 3
     
Settlements
    (7,386 )
Fair value change in contingent consideration
    2,753  
 
     
Balance at June 30, 2011
  $ 117,066  
Transfers to Level 3
     
Settlements
    (10,020 )
Fair value change in contingent consideration
    1,828  
 
     
Balance at September 30, 2011
  $ 108,874  
 
     
We purchase goods and services primarily in U.S. dollars and Canadian dollars, and earn most of our revenues in U.S. dollars. As at each of September 30, 2011 and 2010, we had no outstanding forward foreign currency contracts.
Other financial instruments that potentially subject us to concentration of credit risk include our cash, cash equivalents, accounts receivable, contingent consideration, and mortgage receivable. To limit our credit exposure in regards to cash and cash equivalents, we deposit our cash with high quality financial institutions and the primary goals of our treasury policy are capital preservation and liquidity. Our treasury policy limits investments to certain money market securities issued by governments, financial institutions and corporations with investment-grade credit ratings, and places restrictions on maturities and concentration by issuer.
Our accounts receivable, as at September 30, 2011 and December 31, 2010, comprised amounts primarily owing from Novartis, ASD Specialty Healthcare, Inc. d/b/a Besse Medical (our principal U.S. wholesale distributor of Visudyne) and Priority Healthcare Distribution, Inc. d/b/a CuraScript SD Specialty Distribution.

 

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ITEM 2.  
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following information should be read in conjunction with the accompanying unaudited interim condensed consolidated financial statements and notes thereto, which are prepared in accordance with generally accepted accounting principles (“GAAP”) in the United States (“U.S.”) and our audited consolidated financial statements and notes thereto included as part of our Annual Report on Form 10-K for the year ended December 31, 2010 (our “2010 Annual Report”).
All of the following amounts are expressed in U.S. dollars unless otherwise indicated.
Note regarding Trademarks
The following words used in this Report are trademarks:
   
Avastin® is a registered trademark of Genentech, Inc.
   
Eligard® is a registered trademark of Sanofi S.A.
   
Lucentis® is a registered trademark of Genentech, Inc.
   
Visudyne® is a registered trademark of Novartis AG.
   
Xalatan® is a registered trademark of Pfizer Health AB.
Any words used in this Report that are trademarks but are not referred to above are the property of their respective owners.
OVERVIEW
QLT is an ocular-focused company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide. We are focused on developing our synthetic retinoid program for the treatment of certain inherited retinal diseases, developing our proprietary punctal plug drug delivery system, as well as U.S. marketing of our commercial product, Visudyne®, for the treatment of wet age related macular degeneration (“wet AMD”).
Products, Revenues and Other Sources of Funds
We have one commercial product, Visudyne, which utilizes light-activated photodynamic therapy (“PDT”) to treat the eye disease known as wet AMD, the leading cause of blindness in people over the age of 50 in North America and Europe. Visudyne is also used for the treatment of subfoveal choroidal neovascularization secondary to pathologic myopia, or severe near-sightedness, and presumed ocular histoplasmosis. Visudyne was co-developed by QLT and Novartis Pharma AG (“Novartis”) of Switzerland and is marketed and sold in over 80 countries worldwide.
On January 1, 2010, we received from Novartis the exclusive U.S. rights to the Visudyne patents to sell and market Visudyne in the U.S. As a result, we operate a direct marketing and sales force through our U.S. subsidiary, QLT Ophthalmics, Inc., and have rights to all end-user revenue derived from Visudyne sales in the U.S. Novartis continues to market and sell Visudyne for ophthalmic use outside the U.S. and pays us a royalty on net sales of the product.
On October 1, 2009, we divested the Eligard® line of products to TOLMAR Holding, Inc. (“Tolmar”) as part of the sale of all of the shares of our U.S. subsidiary, QLT USA, Inc. (“QLT USA”). Pursuant to the stock purchase agreement, we are entitled to future consideration payable quarterly in amounts equal to 80% of the royalties paid under the license agreement with Sanofi Synthelabo Inc. (“Sanofi”) for the commercial marketing of Eligard in the U.S. and Canada, and the license agreement with MediGene Aktiengesellschaft (“MediGene”), which, effective March 1, 2011, has been assigned to Astellas Pharma Europe Ltd. (“Astellas”) for the commercial marketing of Eligard in Europe. The estimated fair value of the expected future quarterly payments is reflected as Contingent Consideration on our Condensed Consolidated Balance Sheet. We are entitled to these quarterly payments until the earlier of our receipt of $200.0 million or October 1, 2024. As of September 30, 2011, we had received an aggregate $74.0 million of contingent consideration.

 

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Research and Development
Our current research and development efforts are focused on:
QLT091001 orphan drug program for the treatment of Leber Congenital Amaurosis and Retinitis Pigmentosa. We are currently conducting a Phase Ib clinical proof-of-concept study of QLT091001, a synthetic retinoid therapy for 11-cis-retinal, a key biochemical component of the visual retinoid cycle, in patients with Leber Congenital Amaurosis (“LCA”) and Retinitis Pigmentosa (“RP”). On October 21, 2011, results for the full cohort of 14 LCA subjects and updated longer term visual function data on previously reported subjects were presented at the 2011 American Academy of Ophthalmology Annual Meeting. We continue to monitor and analyze LCA subject follow up and intend to initiate retreatment in subjects as needed. We are also continuing our dialogue with the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) in Europe, with regards to the design and protocol requirements for a pivotal trial for this indication.
Enrolment of up to 14 patients in the RP cohort is ongoing and has been expanded outside of Canada to the U.S. and Europe. We recently received clearance from the FDA for our Investigational New Drug Application (“IND”), and also clearances from the U.K. Medicines and Healthcare Products Regulatory Agency, the Centrale Commissie Mensgebonden Onderzoek (CCMO) (The Netherlands) and the Federal Institute for Drugs and Medical Devices (Germany) for our Clinical Trial Applications, allowing us to proceed with the expansion of investigator sites in the U.S, U.K, The Netherlands, and Germany. Our goal is to complete enrolment of RP patients by year end.
QLT091001 has received orphan drug designations for the treatment of LCA and RP by the EMA, and for the treatment of LCA and RP due to inherited mutations in the LRAT and RPE65 genes by the FDA. These designations provide market exclusivity in the applicable jurisdiction for ten years and seven years, respectively, after a product is approved. QLT091001 has also been granted two Fast Track designations by the FDA for the treatment of the LRAT and RPE65 genetic mutations in both LCA and RP. The FDA’s Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended for the treatment of serious diseases and fill an unmet medical need. In October 2011, we held a Scientific Advice meeting with the EMA to discuss our pivotal trial program for the treatment of LCA.
On May 31, 2011, the United States Patent and Trademark Office issued a key patent related to this program, covering various methods of use of QLT091001 in the treatment of diseases associated with an endogenous 11-cis-retinal deficiency, expiring in 2027. The molecule in QLT091001 is not eligible for composition of matter protection per se, as it was previously known in the scientific community. To further strengthen the patent protection for this program, we continue to pursue additional patent protection in the U.S. and elsewhere covering various aspects of our program. If QLT091001 is approved by the FDA and the EMA for marketing in the U.S. and EU, we plan to apply for any patent term extensions and regulatory exclusivities that are available to us under applicable law.
Punctal Plug Drug Delivery System for the treatment of Glaucoma. We are developing a minimally invasive, proprietary punctal plug drug delivery system with the goal of delivering a variety of drugs topically to the eye through controlled sustained release to the tear film. We are currently targeting the treatment of glaucoma and ocular hypertension with this system. On August 29, 2011, we announced the results of our Phase II clinical study on the safety and efficacy of the latanoprost punctal plug drug delivery program (“L-PPDS”) in subjects with glaucoma and ocular hypertension after four weeks of treatment with the L-PPDS. The trial featured simultaneous placement of latanoprost-eluting punctal plugs in both the upper and lower puncta for delivery of a daily drug load with a goal of enabling comparable clinical outcomes to that of daily administered Xalatan® eye drops. More recently, our ongoing device development work with our new proprietary upper lid punctal plug showed a retention rate of 81% at one month in volunteers (27 eyes). A device study in volunteers to further study the longer term handling, comfort and retention of the new upper plug, as well as other plug iterations, is underway. Additional near term development goals for this program include commencing further Phase II trials in glaucoma to evaluate single versus double plug approaches as well as duration of sustained release. If these trials are successful, our goal is to commence Phase III clinical development activities in 2013.
We believe this platform technology may be suited for delivery of other types of molecules to the tear film of the eye in order to treat anterior segment diseases of the eye. This could include other medications for glaucoma, or other diseases or conditions of the eye including allergy, dry eye, and ocular inflammation. Further development work with our punctal plug delivery system program is ongoing with additional formulation development work for several new product candidates in the prostaglandin and anti-inflammatory areas.

 

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RESULTS OF OPERATIONS
The following table sets out our net (loss) income from operations for the three and nine months ended September 30, 2011 and 2010.
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars, except per share data)   2011     2010     2011     2010  
 
                               
Net (loss) income
  $ (9,106 )   $ (697 )   $ (23,800 )   $ 1,691  
Basic and diluted net (loss) income per common share
  $ (0.18 )   $ (0.01 )   $ (0.47 )   $ 0.03  
Detailed discussion and analysis of our results of operations are as follows:
Revenues
Net product revenue for the three and nine months ended September 30, 2011 and 2010 was determined as follows:
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars)   2011     2010     2011     2010  
 
                               
U.S. Visudyne sales by QLT
  $ 3,853     $ 5,218     $ 15,631     $ 16,668  
Visudyne sales to Novartis
    2,026             4,011       6,988  
Add: Royalties reimbursed to QLT(1)
    337       308       1,051       999  
Add: Other costs reimbursed to QLT(2)
    10       9       31       131  
 
                       
Net product revenue from Visudyne sales
  $ 6,226     $ 5,535     $ 20,724     $ 24,786  
 
                       
Under the terms of the Amended and Restated PDT Product Development, Manufacturing and Distribution Agreement (“Amended PDT Agreement”) with Novartis, on January 1, 2010, we received from Novartis the exclusive U.S. rights to the Visudyne patents to sell and market Visudyne in the U.S. We utilize contract manufacturers for Visudyne production and are responsible for product supply to Novartis and other distributors. Details of our revenue recognition accounting policy are described in Note 1 — Condensed Summary of Significant Accounting Policies in the Notes to the Unaudited Condensed Consolidated Financial Statements.
  (1)  
“Royalties reimbursed to QLT”
     
This represents amounts we receive from Novartis in reimbursement for actual royalty expenses we incur with third party licensors for sales of Visudyne outside of the U.S.
  (2)  
“Other costs reimbursed to QLT”
     
This represents certain administrative expenses we incur on behalf of Novartis under the Amended PDT Agreement.
For the three months ended September 30, 2011, net product revenue from Visudyne increased by $0.7 million, or 13%, to $6.2 million compared to $5.5 million for the same period in 2010. The increase was primarily due to the sale of a batch of Visudyne to Novartis, partially offset by lower Visudyne sales in the U.S.
For the nine months ended September 30, 2011, net product revenue from Visudyne decreased by $4.1 million, or 16%, to $20.7 million compared to $24.8 million for the nine months ended September 30, 2010. The decrease was primarily due to the recognition of $5.0 million of previously deferred revenue in the prior period, following the commencement of the Amended PDT Agreement on January 1, 2010. The deferred revenue related to inventory previously shipped to Novartis for sales outside the U.S.

 

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The tables below summarize end-user Visudyne sales for the three and nine months ended September 30, 2011 and 2010. Under the Amended PDT Agreement with Novartis, Visudyne is sold by QLT in the U.S., and by Novartis outside the U.S. (for which we earn a 20% royalty on net sales). See Note 1 - Condensed Summary of Significant Accounting Policies in the Notes to the Unaudited Condensed Consolidated Financial Statements.
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars)   2011     2010     2011     2010  
 
                               
U.S.
  $ 3,853     $ 5,218     $ 15,631     $ 16,668  
Europe
    5,729       5,303       19,856       19,447  
Rest of World
    11,044       9,945       32,350       30,010  
 
                       
Worldwide
  $ 20,626     $ 20,466     $ 67,837     $ 66,125  
 
                       
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
    2011     2010     2011     2010  
 
                               
U.S.
    19 %     25 %     23 %     25 %
Europe
    28 %     26 %     29 %     29 %
Rest of World
    53 %     49 %     48 %     46 %
 
                       
Worldwide
    100 %     100 %     100 %     100 %
 
                       
The worldwide sale of Visudyne and related royalties are our only sources of revenue. While we have sought to protect our proprietary Visudyne technology by, among other things, obtaining and licensing patents in the U.S., Europe, Japan, and other jurisdictions, because Visudyne is a mature pharmaceutical product, some of the key U.S. patents protecting it have expired or will expire in the near future. For example, one of the U.S. patents (U.S. Patent No. 5,214,036) covering lipid-based formulations of the compound verteporfin (the active ingredient in Visudyne) expired on May 25, 2010, and the U.S. patent (U.S. Patent No. 5,095,030) covering the compound verteporfin expired on September 9, 2011. See Item 1. Business — Patents, Trademarks and Proprietary Rights in our 2010 Annual Report for a more detailed discussion of our Visudyne patent portfolio. Generally, once all patent protection expires, market exclusivity is lost. As is inherent in the biopharmaceutical industry, the loss of market exclusivity can result in significant competition from market entry of generic versions of products, which can have a significant adverse effect on product revenues. However, the effect of the expiration of one or more patents covering a biopharmaceutical product will depend upon a number of factors, such as the extent to which the product is protected by other patents in a relevant jurisdiction, the nature of the market and the position of the product in it, the growth or decline of the market and the complexities and economics of the process for manufacture of the product. Based upon our consideration of these and other factors as they relate specifically to Visudyne, we believe that the expiration of the U.S. patent covering lipid-based formulations of verteporfin in 2010 and the expiration of the U.S. patent covering the compound verteporfin in 2011 are unlikely to have a material adverse effect on our revenues over the next several years since, among other things:
 
we own and license additional U.S. patents covering lipid-based formulations of verteporfin and approved uses of Visudyne that provide additional patent protection for Visudyne and do not expire until, at the latest, 2015 and 2016, respectively;
 
in Europe and Japan, the basic patents covering the verteporfin compound do not expire until 2014 and additional patents and patent applications relating to lipid-based formulations of verteporfin and approved uses of Visudyne do not expire until, at the latest, 2016 and 2017, respectively; and
 
relative to the sale of many other biopharmaceutical products, Visudyne does not generate significant revenue and the manufacturing process is complex, which may make Visudyne a less desirable generic target.
Royalties
Under the Amended PDT Agreement, Novartis continues to market and sell Visudyne outside the U.S. and pays us a 20% royalty on net sales of the product outside the U.S. For the three months ended September 30, 2011, royalty revenues increased by $0.3 million, or 10%, to $3.4 million, compared to $3.1 million for the same period in 2010 and for the nine months ended September 30, 2011, royalty revenues increased by $0.6 million, or 6%, to $10.4 million compared to $9.9 million for the same period in 2010. In each period, royalty revenues increased in line with the increase in Visudyne sales outside the U.S.

 

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Costs and Expenses
Cost of Sales
For the three months ended September 30, 2011, cost of sales increased $0.8 million, or 43%, to $2.7 million compared to $1.9 million in 2010. The increase was primarily due to the sale of a batch of Visudyne to Novartis, offset by lower Visudyne sales in the U.S. For the nine months ended September 30, 2011, cost of sales decreased $4.4 million, or 37%, to $7.4 million compared to $11.8 million for the same period in 2010. The decrease was primarily due to inclusion in the prior period of $4.0 million of cost of sales associated with the recognition of revenue that related to inventory previously shipped to Novartis for sales outside the U.S.
Research and Development
Research and development, or R&D, expenditures increased 39% to $11.3 million for the three months ended September 30, 2011 compared to $8.1 million in the same period in 2010. For the nine months ended September 30, 2011, R&D expenditures increased 42% to $32.3 million compared to $22.8 million in the same period in 2010. For each period, the increase was primarily due to higher spending on our synthetic retinoid program, partially offset by no spending on QLT091568 (Beta Blocker Glaucoma Program) in the three and nine months ended September 30, 2011.
The magnitude of future R&D expenses is highly variable. Numerous events can happen to an R&D project prior to it reaching any particular milestone that can significantly affect future spending and activities related to the project. These events include:
 
inability to design devices to function as expected;
 
delays or inability to formulate an active ingredient in an appropriate concentration to deliver effective doses of a drug;
 
changes in the regulatory environment;
 
introduction of competing technologies and treatments;
 
unexpected safety issues;
 
patent application, maintenance and enforcement issues;
 
inability to operate without infringing the proprietary rights of others;
 
changes in the commercial marketplace;
 
difficulty enrolling patients in, or keeping them in, our clinical studies;
 
inadequate trial design to demonstrate safety and/or efficacy;
 
delays in study progression, including study site, Institutional Review Board and regulatory delays;
 
positive trial results that may result in increased spending;
 
failure to meet favorable study endpoints;
 
inability to develop cost effective manufacturing methods that comply with regulatory standards;
 
inability to attract personnel or retain personnel with appropriate expertise;
 
inability to manufacture sterile supplies necessary for composition of products;
 
uncertainties related to collaborative arrangements;
 
environmental risks; and
 
other factors referenced under Part II, Item 1A, Risk Factors.
We may also undertake new R&D projects that may significantly affect our future spending and activities.
R&D expenditures by therapeutic area were as follows:
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
(In thousands of U.S. dollars)   2011     2010     2011     2010  
 
                               
Ocular
  $ 11,282     $ 8,101     $ 32,334     $ 22,530  
Other
                      246  
 
                       
 
                               
 
  $ 11,282     $ 8,101     $ 32,334     $ 22,776  
 
                       

 

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Selling, General and Administrative Expenses
For the three months ended September 30, 2011, selling, general and administrative, or SG&A, expenses increased 9% to $5.8 million compared to $5.4 million for the three months ended September 30, 2010. The increase was primarily due to increased spending on commercial operations. For the nine months ended September 30, 2011, SG&A expenses increased 26% to $19.2 million compared to $15.2 million for the same period in 2010. The increase was primarily due to increased spending on commercial operations and separation costs related to the departure of our former Chief Medical Officer.
Investment and Other Income
Net Foreign Exchange (Losses) Gains
For the three and nine months ended September 30, 2011 and 2010, net foreign exchange (losses) gains comprise gains and losses from the impact of foreign exchange fluctuations on our monetary assets and liabilities that are denominated in currencies other than the U.S. dollar (principally the Canadian dollar). See the section entitled “Liquidity and Capital Resources — Interest and Foreign Exchange Rates” below.
Interest Income
For the three months ended September 30, 2011, interest income decreased 76% to $0.1 million compared to $0.6 million for the same period in 2010. For the nine months ended September 30, 2011, interest income decreased 67% to $0.5 million compared to $1.6 million for the same period in 2010. For each period the decrease occurred primarily because the prior year included $0.3 million and $0.7 million, respectively, of interest earned on the note receivable from Tolmar which was collected on October 1, 2010 in connection with the sale of QLT USA to Tolmar on October 1, 2009, $0.1 million of interest earned on tax refunds and higher interest earned on the mortgage receivable from Discovery Parks Holdings Ltd.
Fair Value Change in Contingent Consideration
As part of the sale of all of the shares of QLT USA to Tolmar, we are entitled to receive up to $200.0 million in consideration payable on a quarterly basis in amounts equal to 80% of the royalties paid under the license agreements with each of Sanofi and Astellas (formerly with MediGene) for the commercial marketing of Eligard in the U.S., Canada, and Europe. At September 30, 2011, there was $126.0 million remaining to be paid to us by Tolmar. The fair value of this amount, $108.9 million, is reported as Contingent Consideration on our Condensed Consolidated Balance Sheet, and is estimated using a discounted cash flow model. Contingent consideration is revalued at each reporting period and is positively impacted each period by the passage of time, since all remaining expected cash flows move closer to collection, thereby increasing their present value. The fair value change in contingent consideration is also impacted by the projected amount and timing of expected future cash flows and by the cost of capital used to discount these cash flows.
For the three months ended September 30, 2011, the fair value change in contingent consideration decreased to $1.8 million compared to $5.2 million for the same period in 2010. The decrease occurred primarily because the prior period included a favorable impact due to a decrease in the cost of capital used to discount these cash flows, and because of an increase in cash flow projections. In addition, the positive impact on the fair value change in contingent consideration decreases each period as the outstanding balance remaining to be paid to us decreases. For the nine months ended September 30, 2011, the fair value change in contingent consideration decreased to $6.9 million compared to $10.2 million for the same period in 2010. The decrease occurred because of the reduced positive impact due to a lower outstanding balance and also because the prior period included a more favorable increase in cash flow projections.
Income Taxes
The change in the effective tax rate was primarily due to changes in the overall mix of income (loss) in the jurisdictions in which we operate including changes in our valuation allowance in such jurisdictions. In 2010, we completed an intra-entity transfer of intellectual property and, as a result, shifted certain related future development expenditures to the acquiring entity. During 2011, as insufficient evidence exists to support current or future realization of the tax benefits associated with such development expenditures as well as certain other current period expenditures, the benefit of certain tax assets has not been recognized in the current periods. The tax recovery for the nine months ended September 30, 2010 reflected a benefit of $5.6 million which was recorded as a result of the restructuring of our arrangement with Novartis under the Amended PDT Agreement.

 

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LIQUIDITY AND CAPITAL RESOURCES
General
In 2011 and the foreseeable future periods, we expect our cash resources and working capital, cash flow from operations, cash from the collection of the contingent consideration, and other available financing resources to be sufficient to fund current product research and development, operating requirements, liability requirements, acquisition and licensing activities, milestone payments, and repurchases of our common shares.
If adequate capital is not available, our business could be materially and adversely affected. Factors that may affect our future capital requirements include: the status of competitors and their intellectual property rights; levels of future sales of Eligard and our receipt of contingent consideration under the QLT USA stock purchase agreement with Tolmar; levels of future sales of Visudyne; the progress of our R&D programs, including preclinical and clinical testing; future share repurchases; fluctuating or increasing manufacturing requirements; the timing and cost of obtaining regulatory approvals; the levels of resources that we devote to the development of manufacturing, and other support capabilities; technological advances; the cost of filing, prosecuting and enforcing our patent claims and other intellectual property rights; the expiration of our Visudyne patents and potential loss of market exclusivity for Visudyne; pre-launch costs related to commercializing one of our products in development; acquisition and licensing activities; milestone payments; and our ability to establish collaborative arrangements with other organizations.
Sources and Uses of Cash
We finance operations, product development and capital expenditures primarily through existing cash, proceeds from our commercial operations, sales of assets and interest income.
For the three months ended September 30, 2011, we used $0.5 million of cash in operations as compared to generating $12.4 million for the same period in 2010. The $12.9 million negative cash flow variance was primarily attributable to:
   
A negative operating cash flow variance from lower net tax refunds of $5.1 million;
   
A negative operating cash flow variance from higher operating and inventory related expenditures of $3.9 million;
   
A negative operating cash flow variance from proceeds related to the fair value change in contingent consideration of $3.4 million; and
   
A negative operating cash flow variance from lower investment and other income of $0.5 million.
During the three months ended September 30, 2011, cash flows provided by investing activities consisted of proceeds on collection of the contingent consideration of $8.2 million, offset by capital expenditures of $0.5 million.
For the three months ended September 30, 2011, cash flows used in financing activities consisted primarily of common shares repurchased for $4.2 million, including share repurchase costs, offset by $0.1 million received for the issuance of common shares related to the exercise of stock options.
For the nine months ended September 30, 2011, we used $14.4 million of cash in operations as compared to generating $6.4 million for the same period in 2010. The $20.8 million negative cash flow variance was primarily attributable to:
   
A negative operating cash flow variance from higher operating and inventory related expenditures of $12.1 million;
   
A negative operating cash flow variance from lower net tax refunds of $6.1 million;
   
A negative operating cash flow variance from proceeds related to the fair value change in contingent consideration of $3.3 million;
   
A negative operating cash flow variance from lower investment and other income of $1.1 million;
   
A positive operating cash flow variance from higher foreign exchange gains of $0.5 million; and
   
A positive operating cash flow variance from higher cash receipts from product sales and royalties of $1.3 million.
During the nine months ended September 30, 2011, cash flows provided by investing activities consisted of proceeds on collection of the contingent consideration of $21.7 million, and proceeds from the collection of the mortgage receivable of $2.0 million, offset by capital expenditures of $2.0 million.

 

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For the nine months ended September 30, 2011, cash flows used in financing activities consisted primarily of common shares repurchased for $14.6 million, including share repurchase costs, offset by $1.8 million received for the issuance of common shares related to the exercise of stock options.
Interest and Foreign Exchange Rates
We are exposed to market risk related to changes in interest and foreign currency exchange rates, each of which could adversely affect the value of our current assets and liabilities. At September 30, 2011, we had $204.0 million in cash and cash equivalents and our cash equivalents had an average remaining maturity of 17 days. If market interest rates were to increase immediately and uniformly by one hundred basis points from levels at September 30, 2011, the fair value of the cash equivalents would decline by an immaterial amount due to the short remaining maturity period.
The functional currency of QLT Inc. and its U.S. subsidiaries is the U.S. dollar, therefore our U.S. dollar-denominated cash and cash equivalents holdings do not result in foreign currency gains or losses in operations. To the extent that QLT Inc. holds a portion of its monetary assets and liabilities in Canadian dollars, we are subject to translation gains and losses. These translation gains and losses are included in operations for the period.
At September 30, 2011, we had no outstanding forward foreign currency contracts.
Contractual Obligations
Our material contractual obligations as of September 30, 2011 comprised our supply agreements with contract manufacturers, and clinical and development agreements. We also have operating lease commitments for office space, office equipment and vehicles. Details of these contractual obligations are described in our 2010 Annual Report.
Off-Balance Sheet Arrangements
In connection with the sale of assets and businesses, we provide indemnities with respect to certain matters, including product liability, patent infringement, and contractual breaches and misrepresentations, and we provide other indemnities to parties under the clinical trial, license, service, manufacturing, supply, distribution and other agreements that we enter into in the normal course of our business. If the indemnified party were to make a successful claim pursuant to the terms of the indemnification, we would be required to reimburse the loss. These indemnities are generally subject to threshold amounts, specified claims periods and other restrictions and limitations.
Except as described above and the contractual arrangements described in the Contractual Obligations section above, we do not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Recently Issued and Recently Adopted Accounting Standards
Refer to Note 1 — Summary of Significant Accounting Policies in the Notes to Unaudited Condensed Consolidated Financial Statements for a discussion of recently issued and adopted accounting standards.
Outstanding Share Data
As of November 1, 2011, there were 49,363,310 common shares issued and outstanding for a total of $462.4 million in share capital. As of November 1, 2011, we had 6,339,065 stock options outstanding under the QLT 2000 Incentive Stock Option Plan (of which 4,302,085 were exercisable) at a weighted average exercise price of CAD $5.57 per share. Each stock option is exercisable for one common share.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods presented. Significant estimates are used for, but not limited to, provisions for non-completion of inventory, provision for excess inventory, assessment of the recoverability of long-lived assets, the fair value of the mortgage receivable, the fair value of contingent consideration, allocation of costs to manufacturing under a standard costing system, allocation of overhead expenses to research and development, sales rebates and return accruals, determination of fair value of assets and liabilities acquired in net asset acquisitions or purchase business combinations, stock-based compensation, and provisions for taxes, tax assets and tax liabilities. Actual results may differ from estimates made by management. Please refer to our Critical Accounting Policies and Estimates included as part of our 2010 Annual Report.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward looking information” within the meaning of the Canadian securities legislation which are based on our current expectations and projections. Words such as “anticipate,” “project,” “believe,” “expect,” “forecast,” “outlook,” “plan,” “intend,” “estimate,” “should,” “may,” “assume,” “continue” and variations of such words or similar expressions are intended to identify our forward-looking statements and forward-looking information. Such statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of QLT to be materially different from the results of operations or plans expressed or implied by such forward-looking statements and forward-looking information. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying the forward-looking statements and forward-looking information.
The following factors, among others, including those described under Item 1A. Risk Factors in this Report and Item 1A. Risk Factors in our 2010 Annual Report could cause our future results to differ materially from those expressed in the forward-looking statements and forward-looking information:
   
levels of future sales of Visudyne, including the impact of competition, loss of patent protection and limited commercial supply and technical support for laser devices required for Visudyne therapy;
   
our ability to effectively market and sell Visudyne in the U.S.;
   
the ability of Novartis to effectively market and sell Visudyne in countries outside the U.S.;
   
our continued ability to supply Visudyne to our customers;
   
our expectations regarding Visudyne label changes and reimbursement;
   
receipt of all or part of the contingent consideration pursuant to the stock purchase agreement entered into with Tolmar, which is based on anticipated levels of future sales of Eligard;
   
unanticipated future operating results;
   
our reliance on contract manufacturers and suppliers to manufacture Visudyne at competitive prices and in accordance with the U.S. Food and Drug Administration and other local and foreign regulatory requirements as well as our product specifications;
   
our reliance on our specialty wholesale distributors to distribute Visudyne in accordance with regulatory requirements and the terms of our agreements;
   
our expectations regarding future tax liabilities as a result of our recent restructuring transactions, changes in estimates of prior years’ tax items and results of tax audits by tax authorities;
   
the scope, validity and enforceability of our and third party intellectual property rights;
   
our ability to successfully develop our programs, including our punctal plug drug delivery system and synthetic retinoid program;
   
the anticipated timing, cost and progress of the development of our technology and clinical trials;
   
the anticipated timing of regulatory submissions for products and product candidates;
   
the anticipated timing for receipt of, and our ability to maintain, regulatory approvals for products and product candidates;
   
the anticipated timing for receipt of, and our ability to maintain, reimbursement approvals for our products and product candidates, including reimbursement under U.S. governmental and private insurance programs; and
   
existing governmental laws and regulations and changes in, or the failure to comply with, governmental laws and regulations.
Although we believe that the assumptions underlying the forward-looking statements and forward-looking information contained herein are reasonable, any of the assumptions could be inaccurate, and therefore such statements and information included in this Report may not prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements and forward-looking information included herein, the inclusion of such statements and information should not be regarded as a representation by us or any other person that the results or conditions described in such statements and information or our objectives and plans will be achieved. Any forward-looking statement and forward-looking information speaks only as of the date on which it is made. Except to fulfill our obligations under the applicable securities laws, we undertake no obligation to update any such statement or information to reflect events or circumstances occurring after the date on which it is made.

 

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Financial guidance for 2011 is contained in our press release issued on November 3, 2011 which can be found on SEDAR at www.sedar.com and EDGAR at www.sec.gov. Information contained in the press release and related Material Change Report and Current Report on Form 8-K filed therewith shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, and is not incorporated by reference herein.
ITEM 3.  
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
See “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources” in this Report as well as “Item 7A. Quantitative and Qualitative Disclosures about Market Risk” of our 2010 Annual Report.
ITEM 4.  
CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We maintain a set of disclosure controls and procedures designed to ensure that information required to be disclosed in filings made pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified and in accordance with the SEC’s rules and forms and is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial Officer. Our principal executive and financial officers have evaluated our disclosure controls and procedures as of the end of the period covered by this Report and concluded that our disclosure controls and procedures were effective in timely alerting them to material information required to be included in our periodic SEC reports.
It should be noted that the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote. However, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are effective under circumstances where our disclosure controls and procedures should reasonably be expected to operate effectively.
Changes in Internal Control over Financial Reporting
Our internal control over financial reporting is designed with the objective of providing reasonable assurance regarding the reliability of our financial reporting and preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
No change was made to our internal controls over financial reporting during the fiscal quarter ended September 30, 2011 that has materially affected, or is reasonably likely to materially affect, such internal controls over financial reporting.

 

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PART II — OTHER INFORMATION
ITEM 1.  
LEGAL PROCEEDINGS
There are currently no material pending legal proceedings. For information regarding litigation and other risks, uncertainties and other factors that may materially and adversely affect our business, products, financial condition and operating results, refer to Item 1A. Risk Factors in this Report and Item 1A. Risk Factors in our 2010 Annual Report.
ITEM 1A.  
RISK FACTORS
In addition to the risk factors set forth below and other information set forth in this Report, you should carefully consider the factors discussed in “Part 1A. Risk Factors” of our 2010 Annual Report, which could materially affect our business, products, financial condition and operating results.
The risks described below and in our 2010 Annual Report are not the only risks facing us. Additional risks and uncertainties not currently known to us or that we currently deem not to be material also may materially adversely affect our business, products, financial condition and operating results.
Visudyne is currently our only commercial product. Accordingly, any decrease in sales of Visudyne would harm our business.
Visudyne is our only commercial product and, accordingly, any decrease in Visudyne product sales would harm our business and cause our financial results to be below expectations. In 2009, worldwide sales of Visudyne decreased 25.5% from the prior year, primarily due to the approval and reimbursement in Europe of alternative therapeutics for AMD. In 2010, worldwide sales of Visudyne decreased 14.2% from 2009. We cannot assure you that Visudyne product sales will not continue to decrease. Visudyne may be rendered obsolete or uneconomical by competitive changes, including generic competition. Visudyne sales could also be adversely affected by other factors, including:
   
product manufacturing or supply interruptions or recalls;
   
the development of competitive products by other companies;
   
developing and maintaining effective sales and marketing capabilities;
   
marketing or pricing actions by our competitors or regulatory authorities;
   
changes in the reimbursement by third-party payors;
   
changes in or withdrawal of regulatory approval for or the labelling of Visudyne;
   
the majority of the laser devices used in Visudyne therapy have reached, or are nearing, the end of their lifecycle;
   
declining commercial supply and technical support for laser devices used in Visudyne therapy;
   
disputes relating to patents or other intellectual property rights;
   
disputes with our licensees; and
   
changes in laws and regulations that adversely affect our ability to market Visudyne.
We face intense competition, which may limit our commercial opportunities and our ability to generate revenues.
The biopharmaceutical industry is highly competitive and is characterized by rapidly evolving technology. Competition in our industry occurs on many fronts, including developing and bringing new products to market before others, developing new technologies to improve existing products, developing new products to provide the same benefits as existing products at less cost, developing new products to provide benefits superior to those of existing products, and acquiring or licensing complementary or novel technologies from other pharmaceutical companies or individuals.

 

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We face intense competition against Visudyne, as well as our technology under clinical development. We may be unable to contend successfully with current or future competitors. Our competitors include major pharmaceutical and biopharmaceutical companies, many of which are large, well-established companies with access to financial, technical and marketing resources significantly greater than ours and substantially greater experience in developing and manufacturing products, conducting preclinical and clinical testing and obtaining regulatory approvals. Our competitors may develop or acquire new or improved products to treat the same conditions that our products treat, or may make technological advances that reduce their cost of production so that they may engage in price competition through aggressive pricing policies to secure a greater market share to our detriment. Our commercial opportunities will be reduced or eliminated if our competitors develop or acquire and market products that are more effective, have fewer or less severe adverse side effects, or are less expensive than our products. Competitors also may develop or acquire products that make our current or future products obsolete.
In connection with Visudyne, we face significant competition from Lucentis®, an anti-VEGF antibody approved for the treatment of neovascular wet AMD, and diluted Avastin® (bevacizumab), which is also used off-label extensively by physicians to treat wet AMD. In addition, we are aware of other competitive therapies for wet AMD under development. For instance, in April 2011, the FDA granted priority review for Regeneron Pharmaceuticals, Inc.’s Biologics License Application (BLA) for VEGF Trap-Eye for the treatment of neovascular wet AMD. The FDA review deadline for this product is November 18, 2011, which means that, if approved, the VEGF Trap-Eye could launch as early as the fourth quarter of 2011. In addition, EpiRad90, a product under development by NeoVista Inc., has been CE marked in the EU for marketing and is in Phase III clinical trials in the U.S. for the treatment of wet AMD. Further, one of our Visudyne competitors is also our collaborator. Novartis, which, pursuant to the Amended PDT Agreement, has the marketing and sales rights to our Visudyne product outside of the U.S., also has rights to market Lucentis® outside of the U.S.
In connection with our technology under clinical development, including our punctal plug drug delivery technology and synthetic retinoid, our competitors may develop or obtain patent protection for products earlier than us, design around patented technology developed by us, obtain regulatory approval for such products before us, or develop more effective or less expensive products than us.
Any of these competitive products or events could have a significant negative impact on our business and financial results, including reductions in our market share, revenues and gross margins.
Product development is a long, expensive and uncertain process, and we may terminate one or more of our development programs. If we terminate a development program or product candidate, or alternately, if we decide to modify a development program, our prospects may suffer and we may incur significant expenses that could adversely affect our financial condition or results of operations.
We may determine that certain product candidates or programs do not have sufficient potential to warrant the continued allocation of resources to them. Accordingly, we may elect to terminate or modify one or more of our programs, which could include changing our clinical or business model for further development, including by attempting to extract or monetize value from the program by either selling, out-licensing or potentially partnering part or all of the program. If we terminate and seek to monetize part or all of a program in which we have invested significant resources, or we modify a program and expend further resources on it, and subsequently fail to achieve our intended goals, our prospects may suffer, as we will have expended resources on a program that may not provide a suitable return, if any, on our investment and we may have missed the opportunity to allocate those resources to potentially more productive uses. In addition, in the event of a termination of a product candidate or program, we may incur significant expenses and costs, including separation costs, associated with the termination of the program, which could adversely affect our financial condition or results of operations.
Our commercial success depends in part on our ability and the ability of our licensors to obtain and maintain patent protection and/or orphan drug designation and resulting marketing exclusivity on our products and technologies, to preserve trade secrets, and to operate without infringing the proprietary rights of others.
We have applied for and will continue to apply for patents for certain aspects of Visudyne and our product candidates and technology. We have patents and patent applications covering, among other things, compositions, pharmaceutical formulations, processes for manufacturing compounds and/or methods of treating diseases by administering therapeutic compounds. Such applications may not result in the issuance of any patents, and any patents now held or that may be issued may not provide us with a preferred position with respect to any product or technology.
We may not be able to obtain patent protection on aspects of our product candidates and technology. For example, while U.S. Patent No. 7,951,841 was issued on May 31, 2011 covering various methods of use of QLT091001 in the treatment of diseases associated with an endogenous 11-cis-retinal deficiency until 2027, the molecule in QLT091001 is not eligible for composition of matter protection in the U.S. or elsewhere because it was previously known in the scientific community. Therefore, we may not be able to prevent competitors from commercializing the molecule in QLT091001 for the treatment of diseases that fall outside of the scope of our patents protecting this program.

 

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The FDA and EMA have granted QLT091001 orphan drug designations for the treatment of LCA and RP, which gives us seven years and 10 years, respectively, of market exclusivity for the use of QLT091001 for the treatment of LCA and RP from the date that QLT091001 is approved, if it is approved. However, this market exclusivity does not pertain to indications outside of the scope of our patents, nor does it prevent other types of drugs from receiving orphan designations or approvals in these same indications.
Patents issued or licensed to us may be challenged, invalidated or circumvented successfully, or may have expired or expire in the near future. For example, some of the key U.S patents protecting Visudyne have expired or will expire in the near future, with the remaining unexpired patents having varying strengths and duration. To the extent a preferred position is conferred by patents we own or license, upon expiry of such patents, or if such patents are successfully challenged, invalidated or circumvented, our preferred position may be lost. We may not be able to develop and successfully launch more advanced replacement products and/or technologies before our patents expire. If we fail to develop and successfully launch new products prior to the expiry of patents for our products, our revenue from those products could decline significantly.
Further, upon the expiry of, or successful challenge to, our patents covering a product, including Visudyne, generic competitors may introduce a generic version of that product, thereby adversely affecting our revenue and profitability. Generic competitors typically sell their products at prices much lower than those charged by the innovative pharmaceutical or biotechnology companies who have incurred substantial expenses associated with the research and development of the drug product. As a result of this possible increase in competition, we may need to lower our prices in order to maintain sales of our products or we may lose a competitive advantage and marketability of our products and technologies. In the case of Visudyne, the loss of a preferred position may have a material adverse effect on our business, cash flow, results of operations and financial position.
Patents issued or licensed to us may be infringed by the products or processes of other parties. The cost of enforcing our patent rights against infringers, if such enforcement is required, could be significant, and the time demands could interfere with our normal operations.
It is also possible that a court may find us to be infringing validly issued patents of third parties. In that event, in addition to the cost of defending the underlying suit for infringement, we may have to pay license fees and/or damages and may be enjoined from conducting certain activities. Obtaining licenses under third-party patents can be costly, and such licenses may not be available at all. Under such circumstances, we may need to materially alter our products or processes, may be unable to launch a product or may lose the right to continue to manufacture and sell a product entirely or for a period of time.
Unpatented trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and commercial success. Although we attempt to, and will continue to attempt to, protect our proprietary information through reliance on trade secret laws and the use of confidentiality agreements with our collaborators, contract manufacturers, licensees, employees and consultants and other appropriate means, these measures may not effectively prevent disclosure of or access to our proprietary information, and, in any event, others may develop independently, or obtain access to, the same or similar information.
ITEM 2.  
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On December 8, 2010, we announced that our Board of Directors authorized the repurchase of up to 3.6 million of our issued and outstanding common shares, being 10% of our public float as of December 9, 2010, over a 12 month period commencing December 16, 2010 under a normal course issuer bid. All purchases are to be effected in the open market through the facilities of the TSX or NASDAQ, and in accordance with regulatory requirements. The actual number of common shares which are purchased and the timing of such purchases are determined by management, subject to compliance with applicable law. All common shares repurchased will be cancelled. In accordance with TSX rules, daily purchases made by us on the TSX will not exceed 3,604 common shares (25% of our average daily trading volume of 14,414 common shares on the TSX for the six completed calendar months prior to TSX approval of the normal course issue bid) subject to certain prescribed exemptions. Rule 10b-18 of the U.S. Securities Exchange Act of 1934, as amended, contains similar restrictions on daily purchases that may be made by us on the NASDAQ based on 25% of the average daily trading volume of our common shares on NASDAQ for the most recently completed four calendar weeks on a rolling basis, subject to certain exemptions for block purchases. The price that we will pay for any such shares will be the market price on the TSX or the NASDAQ, as the case may be, at the time of acquisition. Since initiating this normal course issuer bid, to November 3, 2011, we have repurchased through the facilities of the NASDAQ, and immediately cancelled, an aggregate 2,191,817 common shares at an average price of $7.02 per share, for a total cost of $15.4 million. Shareholders may obtain a copy of our TSX Form 12 — Notice of Intention to Make a Normal Course Issuer Bid, without charge, by request directed to the attention of our Secretary, at our offices located at 887 Great Northern Way, Suite 101, Vancouver, B.C., Canada V5T 4T5.

 

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The following table sets forth information regarding our purchases of common shares on a monthly basis during the three months ended September 30, 2011:
                                 
Issuer Purchases of Equity Securities  
                    Total Number of     Maximum Number  
    Total             Shares Purchased as     of Shares that May  
    Number of     Average     Part of Publicly     Yet Be Purchased  
    Shares     Price Paid     Announced Plans or     Under the Plans or  
Period   Purchased     per Share     Programs     Programs  
July 1, 2011 through July 31, 2011
                      2,052,913  
 
                               
August 1, 2011 through August 31, 2011
    82,300     $ 7.19       82,300       1,970,613  
 
                               
September 1, 2011 through September 30, 2011
    547,145     $ 7.14       547,145       1,423,468  
 
                       
 
                               
Total
    629,445     $ 7.15       629,445       1,423,468  
 
                       
ITEM 6.  
EXHIBITS
The exhibits filed or furnished with this Report are set forth in the Exhibit Index.

 

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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.
         
  QLT Inc.
(Registrant)
 
 
Date: November 3, 2011  By:   /s/ Robert L. Butchofsky    
    Robert L. Butchofsky   
    President and Chief Executive Officer
(Principal Executive Officer) 
 
         
Date: November 3, 2011  By:   /s/ Cameron R. Nelson    
    Cameron R. Nelson   
    Senior Vice President, Finance and
Chief Financial Officer
(Principal Financial and Accounting Officer) 
 

 

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EXHIBIT INDEX
         
Exhibit    
Number   Description
       
 
  31.1    
Rule 13a-14(a) Certification of the Chief Executive Officer.
       
 
  31.2    
Rule 13a-14(a) Certification of the Chief Financial Officer.
       
 
  32.1    
Section 1350 Certification of the Chief Executive Officer.
       
 
  32.2    
Section 1350 Certification of the Chief Financial Officer.

 

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