EX-99.1 2 d577754dex991.htm EXHIBIT 99.1 PRESS RELEASE DATED AUGUST 1,2013 Exhibit 99.1 Press Release dated August 1,2013

Exhibit 99.1

 

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News release

QLT ANNOUNCES SECOND QUARTER 2013 RESULTS

For Immediate Release August 1, 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 second quarter ended June 30, 2013. Unless specified otherwise, all amounts are in U.S. dollars and in accordance with U.S. GAAP.

2013 SECOND QUARTER FINANCIAL RESULTS

Discontinued Operations Reporting

On September 24, 2012, the Company announced that it completed the sale of its Visudyne® business to Valeant Pharmaceuticals International, Inc. On April 3, 2013, the Company completed the sale of its punctal plug delivery system technology (the “PPDS Technology”) to Mati Therapeutics Inc. In accordance with the accounting standard for discontinued operations, the results of operations relating to both the Visudyne business and the PPDS Technology have been excluded from continuing operations and reported as discontinued operations for the current and prior periods.

QLT Expenses / Other Income

Research and Development (R&D) expenses relate to QLT’s synthetic retinoid program. During the second quarter of 2013, R&D expense was $4.4 million compared to $7.5 million for the same period in 2012. The $3.1 million decrease was primarily due to savings from the Company’s 2012 restructuring initiatives and higher spending in 2012 related to the completion of certain early stage safety studies and manufacturing activities required to support clinical studies.

During the second quarter of 2013, Selling, General and Administrative (SG&A) expense was $1.8 million compared to $5.9 million for the same period in 2012. The $4.1 million decrease was primarily due to savings from the Company’s 2012 restructuring initiatives.

Investment and Other Income was $1.2 million for the second quarter of 2013. This primarily consists of a $1.0 million gain related to the Fair Value Change in the Contingent Consideration asset. This gain occurred primarily because our contingent consideration assets are recorded as the present value of future expected payments with respect to Eligard® and Visudyne, and therefore as each quarter elapses, even if no changes are made to the underlying Eligard and Visudyne contingent consideration forecasts, a gain will be booked related to the time value of money as we move closer to realizing the full face value of the future expected payments.


Operating Loss

The operating loss for the second quarter of 2013 was $7.1 million, compared to a $13.7 million operating loss incurred during the same period in the prior year. The $6.6 million improvement in operating results is primarily due to savings from our 2012 restructuring initiatives and reduced spending on our synthetic retinoid program offset by $0.7 million of restructuring costs incurred during the quarter.

(Loss) Income from Discontinued Operations, Net of Income Taxes

For the second quarter of 2013, we incurred a $0.2 million loss from discontinued operations, net of income taxes, compared to a $4.1 million loss from discontinued operations for the same period in 2012.

Loss Per Share

Loss per share was $0.12 in the second quarter of 2013 compared to a $0.33 loss per share in the second quarter of 2012. The improvement was primarily due to restructuring savings and lower spending on the synthetic retinoid program, partially offset by restructuring charges and a lower gain from the Fair Value Change in Contingent Consideration in the current period.

Cash and Cash Equivalents and Restricted Cash

The Company’s consolidated cash balance at June 30, 2013 consisted of $103.2 million of cash and cash equivalents and $7.5 million of restricted cash, down from $307.4 million of cash and cash equivalents and $7.5 million of restricted cash 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 on June 27, 2013, and $13.5 million of common share repurchases completed in the first quarter of 2013. During the second quarter of 2013, proceeds received in connection with collection of the Eligard Contingent Consideration totaled $8.0 million ($18.9 million collected during the six months ended June 30, 2013). In addition, we still have up to $57.9 million of Eligard Contingent Consideration remaining to be collected.

“During our first year as your fiduciaries, QLT’s Board of Directors is very pleased to have reduced SG&A and non-retinoid development expenses by approximately 70% and returned significant capital to shareholders in such a tax-efficient manner; while simultaneously advancing the development of our orphan-disease-focused synthetic oral retinoid program. Throughout the balance of 2013, your Board will continue its efforts to maximize value for our shareholders, including further advancing QLT091001. We look forward to updating you on our development plans for QLT091001 by year-end 2013,” said Jason M. Aryeh, Chairman of the Board.

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

In accordance with United States generally accepted accounting principles

(Unaudited)

 

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

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

   2013     2012     2013     2012  

Expenses

        

Research and development

    $ 4,392       $ 7,465       $ 8,472       $ 13,981   

Selling, general and administrative

     1,810        5,872        3,892        9,980   

Depreciation

     252        326        487        689   

Restructuring charges

     671        —          1,493        —     
  

 

 

   

 

 

   

 

 

   

 

 

 
     7,125        13,663        14,344        24,650   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (7,125     (13,663     (14,344     (24,650

Investment and other income

        

Net foreign exchange gains (losses)

     84        (32     18        (150

Interest income

     80        56        136        88   

Fair value change in contingent consideration

     1,038        1,650        1,833        3,591   

Other gains

     36        29        36        83   
  

 

 

   

 

 

   

 

 

   

 

 

 
     1,238        1,703        2,023        3,612   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from continuing operations before income taxes

     (5,887     (11,960     (12,321     (21,038

Provision for income taxes

     (142     (251     (325     (548
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from continuing operations

     (6,029     (12,211     (12,646     (21,586
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) Income from discontinued operations, net of income taxes

     (170     (4,093     20        (4,995

Net loss and comprehensive loss

   ($ 6,199   ($ 16,304   ($ 12,626   ($ 26,581
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per common share

        

Continuing operations

   ($ 0.12   ($ 0.25   ($ 0.25   ($ 0.44

Discontinued operations

   ($ 0.00   ($ 0.08    $ 0.00      ($ 0.10
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share

   ($ 0.12   ($ 0.33   ($ 0.25   ($ 0.54
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of common shares outstanding (thousands)

        

Basic and diluted

     50,883        49,191        50,736        49,088   


QLT Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

In accordance with United States generally accepted accounting principles

(Unaudited)

 

(In thousands of U.S. dollars)

   June 30,
2013
    December 31,
2012
 

ASSETS

    

Current assets

    

Cash and cash equivalents

   $ 103,180      $ 307,384   

Restricted cash

     7,502        7,500   

Accounts receivable

     684        3,960   

Contingent consideration—current

     40,627        41,255   

Income taxes receivable

     600        554   

Deferred income tax assets—current

     362        644   

Assets held for sale

     —          300   

Prepaid and other

     2,396        1,442   
  

 

 

   

 

 

 

Total current assets

     155,351        363,039   

Property, plant and equipment

     2,235        2,655   

Deferred income tax assets—non-current

     230        370   

Contingent consideration—non-current

     18,743        35,154   
  

 

 

   

 

 

 

Total assets

     176,559        401,218   
  

 

 

   

 

 

 

LIABILITIES

    

Current liabilities

    

Accounts payable

     3,319      $ 6,121   

Accrued liabilities

     1,189        2,515   

Accrued restructuring charge

     666        1,933   

Deferred income

     —          456   
  

 

 

   

 

 

 

Total current liabilities

     5,174        11,025   

Uncertain tax position liabilities

     1,813        1,875   
  

 

 

   

 

 

 

Total liabilities

     6,987        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

    

June 30, 2013 – 51,081,878 shares

    

December 31, 2012 – 51,589,405 shares

    

Additional paid-in capital

     95,387        296,024   

Accumulated deficit

     (495,013     (482,387

Accumulated other comprehensive income

     102,969        102,969   
  

 

 

   

 

 

 

Total shareholders’ equity

     169,572        388,318   
  

 

 

   

 

 

 

Total shareholders’ equity and liabilities

   $ 176,559      $ 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 ability to maximize the value of our assets, including further progressing QLT091001; 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.