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8-K - FORM 8-K - NOVELION THERAPEUTICS INC.d626516d8k.htm

Exhibit 99.1

 

LOGO

News release

QLT ANNOUNCES THIRD QUARTER 2013 RESULTS

 

For Immediate Release   November 7, 2013

VANCOUVER, CANADA — QLT Inc. (NASDAQ: QLTI; TSX: QLT) (“QLT” or the “Company”) is a biotechnology company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide. The Company today reported financial results for the third quarter ended September 30, 2013. Unless specified otherwise, all amounts are in U.S. dollars and in accordance with U.S. GAAP.

2013 THIRD QUARTER FINANCIAL RESULTS

QLT Expenses / Other Income

Research and Development (R&D) expenses relate to QLT’s synthetic retinoid program. During the third quarter of 2013, R&D expense was $5.2 million compared to $5.6 million for the same period in 2012. The $0.4 million decrease was primarily due to savings from the Company’s 2012 R&D workforce reduction.

During the third quarter of 2013, Selling, General and Administrative (SG&A) expense was $1.7 million compared to $2.7 million for the same period in 2012. The $1.0 million decrease was primarily due to savings from the Company’s 2012 restructuring initiatives.

Operating Loss

The operating loss for the third quarter of 2013 was $7.5 million, compared to an operating loss of $19.9 million recorded during the same period in 2012. The $12.4 million improvement in operating results is primarily due to restructuring charges recorded in 2012 and savings related to the 2012 restructuring initiatives.

Income from Discontinued Operations, Net of Income Taxes

During the third quarter of 2013, we earned $0.1 million of income from discontinued operations, net of income taxes, compared to $94.1 million for the same period in 2012. The decrease was primarily due to a pre-tax gain of $101.4 million related to the divestment of the Visudyne® business in the third quarter of 2012.

(Loss) / Income Per Share

Loss per share from continuing operations was $0.15 in the third quarter of 2013 compared to a loss per share from continuing operations of $0.25 in the third quarter of 2012. The improvement was primarily due to restructuring charges recorded in 2012 and savings related to the 2012 restructuring initiatives. These improvements were partially offset by a lower gain from the Fair Value Change in Contingent Consideration in the current period, as well as the 2012 income tax recovery resulting from the recognition of the tax benefit of our operating losses from continuing operations.


Income per share from discontinued operations was negligible in the third quarter of 2013 compared to income per share from discontinued operations of $1.86 in the third quarter of 2012, which was primarily due to the $101.4 million pre-tax gain related to the sale of our Visudyne business.

Cash and Cash Equivalents

As at September 30, 2013, the Company’s consolidated cash balance consisted of $114.1 million of cash and cash equivalents, down from $307.4 million of cash and cash equivalents at the end of 2012. The decrease was largely due to the $200 million special cash distribution to the Company’s shareholders, which was completed in June 2013, partially offset by $7.5 million of funds that were released to us from escrow on September 26, 2013. During the third quarter of 2013, proceeds received in connection with collection of the Eligard Contingent Consideration totaled $9.3 million ($28.2 million collected during the nine months ended September 30, 2013). In addition, we still have up to $48.6 million of Eligard Contingent Consideration remaining to be collected.

Passive Foreign Investment Company

The Company believes that it was classified as a Passive Foreign Investment Company (PFIC) for 2008 – 2012, and that it may be classified as a PFIC in 2013, which could have adverse tax consequences for U.S. shareholders. Please refer to our Annual Report on Form 10-K for additional information.


QLT Inc.—Financial Highlights

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME

In accordance with United States generally accepted accounting principles

(Unaudited)

 

     Three months ended     Nine months ended  
     September 30,     September 30,  

(In thousands of U.S. dollars except share and per share information)

   2013     2012     2013     2012  

Expenses

        

Research and development

   $ 5,243      $ 5,639      $ 13,715      $ 19,621   

Selling, general and administrative

     1,676        2,669        5,568        12,648   

Depreciation

     230        238        717        927   

Restructuring charges

     354        11,402        1,847        11,402   
  

 

 

   

 

 

   

 

 

   

 

 

 
     7,503        19,948        21,847        44,598   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (7,503     (19,948     (21,847     (44,598

Investment and other income

        

Net foreign exchange gains (losses)

     (54     65        (36     (84

Interest income

     39        59        175        147   

Fair value change in contingent consideration

     71        2,840        1,904        6,432   

Other gains

     64        21        100        102   
  

 

 

   

 

 

   

 

 

   

 

 

 
     120        2,985        2,143        6,597   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from continuing operations before income taxes

     (7,383     (16,963     (19,704     (38,001

(Provision for) Recovery of income taxes

     (109     4,345        (434     3,798   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from continuing operations

     (7,492     (12,618     (20,138     (34,203
  

 

 

   

 

 

   

 

 

   

 

 

 

Income from discontinued operations, net of income taxes

     96        94,078        116        89,082   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income and comprehensive (loss) income

     ($7,396   $ 81,460        ($20,022   $ 54,879   
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net (loss) income per common share

        

Continuing operations

     ($0.15     ($0.25     ($0.40     ($0.69

Discontinued operations

   $ 0.00      $ 1.86      $ 0.00      $ 1.80   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income per common share

     ($0.14   $ 1.61        ($0.39   $ 1.11   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of common shares outstanding (thousands)

        

Basic and diluted

     51,082        50,600        50,851        49,592   


QLT Inc.—Financial Highlights

CONDENSED CONSOLIDATED BALANCE SHEETS

In accordance with United States generally accepted accounting principles

(Unaudited)

 

(In thousands of U.S. dollars)

   September 30, 2013     December 31, 2012  

ASSETS

    

Current assets

    

Cash and cash equivalents

   $ 114,086      $ 307,384   

Restricted cash

     —          7,500   

Accounts receivable

     755        3,960   

Contingent consideration—current

     40,557        41,255   

Income taxes receivable

     404        554   

Deferred income tax assets—current

     316        644   

Assets held for sale

     —          300   

Prepaid and other

     1,705        1,442   
  

 

 

   

 

 

 

Total current assets

     157,823        363,039   

Property, plant and equipment

     2,180        2,655   

Deferred income tax assets—non-current

     195        370   

Contingent consideration—non-current

     9,569        35,154   
  

 

 

   

 

 

 

Total assets

     169,767        401,218   
  

 

 

   

 

 

 

LIABILITIES

    

Current liabilities

    

Accounts payable

     3,924      $ 6,121   

Accrued liabilities

     1,407        2,515   

Accrued restructuring charge

     249        1,933   

Deferred income

     —          456   
  

 

 

   

 

 

 

Total current liabilities

     5,580        11,025   

Uncertain tax position liabilities

     1,874        1,875   
  

 

 

   

 

 

 

Total liabilities

     7,454        12,900   
  

 

 

   

 

 

 

SHAREHOLDERS’ EQUITY

    

Share capital

    

Authorized

    

500,000,000 common shares without par value

    

5,000,000 first preference shares without par value, issuable in series

    

Issued and outstanding

     466,229        471,712   

Common shares

    

September 30, 2013 – 51,081,878 shares

    

December 31, 2012 – 51,589,405 shares

    

Additional paid-in capital

     95,524        296,024   

Accumulated deficit

     (502,409     (482,387

Accumulated other comprehensive income

     102,969        102,969   
  

 

 

   

 

 

 

Total shareholders’ equity

     162,313        388,318   
  

 

 

   

 

 

 

Total shareholders’ equity and liabilities

   $ 169,767      $ 401,218   
  

 

 

   

 

 

 


About QLT

QLT is a biotechnology 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.

QLT’s head office is based in Vancouver, Canada and the Company is publicly traded on NASDAQ Stock Market (symbol: QLTI) and the Toronto Stock Exchange (symbol: QLT). For more information about the Company’s products and developments, please visit our web site at www.qltinc.com.

QLT Inc. Contacts:

Investor & Media Relations

Andrea Rabney or David Pitts

Argot Partners

212-600-1902

andrea@argotpartners.com

david@argotpartners.com

Visudyne® is a registered trademark of Novartis AG

Eligard® is a registered trademark of Sanofi S.A.

Certain statements in this press release constitute “forward-looking statements” of QLT within the meaning of the Private Securities Litigation Reform Act of 1995 and constitute “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to: statements concerning our PFIC status; and statements which contain language such as: “assuming,” “prospects,” “goal,” “future,” “projects,” “potential,” “believes,” “expects,” “hopes,” and “outlook.” Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company’s future operating results are uncertain and likely to fluctuate; currency fluctuations; the risk that sales of Visudyne or Eligard may be less than expected thereby impacting our contingent consideration; the risk that we may not receive any or as much additional contingent consideration as we might expect under our agreements with respect to the sale of Visudyne, Eligard and the PPDS Technology; risks and uncertainties concerning the impacts that QLT’s strategic initiatives will have on the market price of our securities; risks resulting from recent changes in personnel; uncertainties relating to our development plans, timing and results of the clinical development and commercialization of our products and technologies; assumptions related to continued enrollment trends, efforts and success, and the associated costs of these programs; outcomes for our clinical trials may not be favorable or may be less favorable than interim/preliminary results and/or previous trials; there may be varying interpretations of data produced by one or more of our clinical trials; risks and uncertainties associated with the safety and effectiveness of our technology; the timing, expense and uncertainty associated with the regulatory approval process for products to advance through development stages; risks and uncertainties related to the scope, validity, and enforceability of our intellectual property rights and the impact of patents and other intellectual property of third parties; and general economic conditions and other factors described in detail in QLT’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Forward-looking statements are based on the current expectations of QLT and QLT does not assume any obligation to update such information to reflect later events or developments except as required by law.

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