NOVELION THERAPEUTICS INC 
By
"We are pleased to report another quarter of profitability, driven by our revenue streams from Visudyne(R) and Eligard(R)," said
2009 FIRST QUARTER FINANCIAL RESULTS
Worldwide Product Sales
Visudyne sales for the first quarter were
Worldwide Eligard sales in the first quarter were
QLT Revenues
For the first quarter, total revenue of
QLT Expenses
For the first quarter of 2009, Research and Development (R&D) expense was
Operating Income/Loss
Operating income for the first quarter was
Earnings Per Share (EPS)/Loss Per Share
EPS of
In the first quarter, non-GAAP EPS was
Cash and Short-Term Investments
The Company's consolidated cash balance at
RECENT COMPANY ANNOUNCEMENTS
- Announced the results from a Phase Ia trial of QLT091001 in healthy
adult volunteers. The trial demonstrated the drug is safe and well-
tolerated and achieved its primary goal of estimating an appropriate
dose for studies in patients. QLT091001 is an orally administered
synthetic retinoid replacement for 11-cis-retinal and is being
developed for the potential treatment of Leber's Congenital Amaurosis
(LCA), an inherited progressive retinal degenerative disease that
leads to retinal dysfunction and visual impairment beginning at
birth.
- Announced the appointment of Ms. Kathryn Falberg to the Company's
board of directors and audit committee, effective March 25, 2009. Her
appointment brings the board membership to seven directors who will
all stand for re-election at the Annual General Meeting of
Shareholders on May 5, 2009.
- Announced that the United States Court of Appeals for the First
Circuit (the "Court of Appeals") denied our Petition for Panel
Rehearing and Rehearing En Banc ("QLT Petition") of the January 12,
2009 Court of Appeals decision in our litigation with MEEI. The QLT
Petition was filed on January 26, 2009. The January 12, 2009 Court of
Appeals decision upheld the liability and damages aspect of the 2007
judgment of the United States District Court for the District of
Massachusetts in the lawsuit brought against us by MEEI.
- Announced that QLT was the defendant in a lawsuit filed by
Massachusetts General Hospital (MGH) in Massachusetts state court.
MGH alleges that it entered into a written agreement with QLT that
requires QLT to pay MGH the same royalties that it pays MEEI on sales
of Visudyne, as determined by the District Court and affirmed by the
Court of Appeals.
- Announced the final results of a modified Dutch Auction tender offer
whereby QLT accepted for purchase and cancellation 20,000,000 of its
common shares at a price of $2.50 per share, for a total cost of
$50.0 million.
Conference call information
QLT Inc. will hold an investor conference call to discuss first quarter 2009 results on
About QLT
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. Our research and development efforts are focused on pharmaceutical products in the field of ophthalmology. In addition, we utilize three unique technology platforms, photodynamic therapy, Atrigel(R) and punctal plugs with drugs, to create products such as Visudyne(R) and Eligard(R) and future product opportunities. For more information, visit our web site at www.qltinc.com.
QLT Inc. - Financial Highlights
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Three months ended
March 31,
(In thousands of United States dollars,
except per share information) 2009 2008
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(Unaudited)
Revenues
Net product revenue $ 20,817 $ 20,016
Royalties 8,907 6,301
Licensing, milestones and other 367 377
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$ 30,091 $ 26,694
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Costs and expenses
Cost of sales(1) 12,998 11,757
Research and development 5,886 8,048
Selling, general and administrative 5,202 7,164
Depreciation 344 1,022
Litigation 334 -
Restructuring (123) 7,599
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24,641 35,589
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Operating income (loss) 5,450 (8,895)
Investment and other income (expense)
Net foreign exchange gains 49 254
Interest income 1,377 2,318
Interest expense (1,503) (3,028)
Other 64 153
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(13) (303)
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Income (loss) from continuing
operations before income taxes 5,437 (9,198)
Recovery of (provision for) income taxes (4,136) 164
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Income (loss) from continuing operations 1,301 (9,034)
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Loss from discontinued operations,
net of income taxes - (1,437)
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Net income (loss) $ 1,301 $ (10,471)
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Basic net income (loss) per common share
Continuing operations $ 0.02 $ (0.12)
Discontinued operations - (0.02)
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Net income (loss) $ 0.02 $ (0.14)
Diluted net income (loss) per common share
Continuing operations $ 0.02 $ (0.12)
Discontinued operations - (0.02)
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Net income (loss) $ 0.02 $ (0.14)
Weighted average number of
common shares outstanding (in thousands)
Basic 61,287 74,620
Diluted 61,287 74,620
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(1) Includes amount accrued on Visudyne sales pursuant to judgment
rendered in the MEEI litigation.
QLT Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
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(In accordance with United States generally accepted accounting
principles)
March 31, December 31,
(In thousands of United States dollars) 2009 2008
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(Unaudited)
ASSETS
Current assets
Cash and cash equivalents $ 130,149 $ 165,395
Restricted cash 124,847 124,578
Accounts receivable 24,634 31,096
Income taxes receivable 47,009 50,899
Inventories 9,105 11,633
Current portion of deferred
income tax assets 7,683 9,835
Other 8,581 11,144
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352,008 404,580
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Property, plant and equipment 2,753 3,184
Deferred income tax assets 29,319 30,216
Goodwill 23,145 23,145
Mortgage receivable 9,525 9,834
Long-term inventories and other assets 21,574 20,799
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$ 438,324 $ 491,758
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LIABILITIES
Current liabilities
Accounts payable $ 8,701 $ 9,115
Accrued restructuring charge 177 726
Accrued liabilities 129,804 129,512
Current portion of deferred revenue 5,245 5,673
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143,927 145,026
Uncertain tax position liabilities 1,815 2,033
Deferred revenue 1,102 1,469
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146,844 148,528
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SHAREHOLDERS' EQUITY
Common shares 514,009 702,221
Additional paid-in capital 267,906 123,367
Accumulated deficit (578,263) (579,564)
Accumulated other comprehensive income 87,828 97,206
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291,480 343,230
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$ 438,324 $ 491,758
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As at March 31, 2009, there were 54,620,328 issued and outstanding common
shares and 5,103,929 outstanding stock options.
QLT Inc.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
2009 First Quarter Reconciliation of GAAP Earnings to
Adjusted Non-GAAP Earnings Exhibit 1
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(In millions of Three months Three months
United States dollars, ended ended
except per share March 31, 2009 March 31, 2009
information) GAAP Adjustments Non-GAAP(1)
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(Unaudited)
Revenues
Net product revenue $ 20.8 $ - $ 20.8
Royalties 8.9 - 8.9
Licensing, milestones
and other 0.4 (0.4) (a) -
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30.1 (0.4) 29.7
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Cost and expenses
Cost of sales (13.0) 0.0 (b) (13.0)
Research and development (5.9) 0.2 (b) ( 5.7)
Selling, general and
administrative (5.2) 0.3 (b) (4.9)
Depreciation (0.3) - ( 0.3)
Litigation (0.3) 0.3 (c) -
Restructuring 0.1 (0.1) (d) -
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(24.6) 0.8 (23.9)
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Operating income 5.5 0.4 5.8
Investment and other
income (expense)
Net foreign exchange gains 0.1 - 0.1
Interest income 1.4 (0.7) (e) 0.7
Interest expense (1.5) - (1.5)
Other 0.1 - 0.1
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(0.0) (0.7) (0.7)
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Income from continuing
operations before income taxes 5.4 (0.3) 5.1
Recovery of (provision for)
income taxes (4.1) 0.2 (f) (3.9)
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Income from continuing operations 1.3 (0.1) 1.2
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Income from discontinued
operations, net of income taxes - - -
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Net income $ 1.3 $ (0.1) $ 1.2
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Basic net income per
common share:
Continuing operations $ 0.02 $ 0.02
Discontinued operations - -
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Net income $ 0.02 $ 0.02
Diluted net income per
common share:
Continuing operations $ 0.02 $ 0.02
Discontinued operations - -
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Net income $ 0.02 $ 0.02
Weighted average number of
common shares outstanding
(in millions)
Basic 61.3 61.3
Diluted 61.3 61.3
Adjustments:
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(a) Remove licensing and milestone revenue.
(b) Remove stock-based compensation.
(c) Remove litigation expense.
(d) Remove restructuring adjustment.
(e) Remove interest income related to income tax refund.
(f) Remove income tax impact of the above adjustments.
(1) The adjusted non-GAAP financial measures have no standardized meaning
under GAAP and are not comparable between companies. Management believes
that the adjusted non-GAAP financial measures are useful for the purpose
of financial analysis. Management uses these measures internally to
evaluate the Company's operating performance before items that are
considered by management to be outside of the Company's core operating
results.
A full explanation of how QLT determines and recognizes revenue resulting from Visudyne sales is contained in the financial statements contained in the periodic reports on Forms 10-Q and 10-K, under the heading "Significant Accounting Policies - Revenue Recognition." Visudyne sales are product sales by Novartis under its agreement with QLT.
QLT Plug Delivery, Inc. is a wholly-owned subsidiary of QLT Inc.
Atrigel is a registered trademark of QLT USA, Inc.
Visudyne is a registered trademark of Novartis AG.
Eligard is a registered trademark of Sanofi-aventis.
QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol "QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT."
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: our expectations for the development of our punctal plug platform; our expectations for timing to receive results from our on-going Phase II punctal plug study; our expectations for timing to receive results relating to our Visudyne RADICAL combination study and the Novartis sponsored MONTBLANC Visudyne combination study; our expectation that positive data from the combination studies could help drive Visudyne sales; and statements which contain language such as: "assuming," "prospects," "future," "projects," "believes," "expects" 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; uncertainties relating to the timing and results of the clinical development and commercialization of our products and technologies (including Visudyne and our punctal plug technology) and the associated costs of these programs; the timing, expense and uncertainty associated with the regulatory approval process for products; uncertainties regarding the impact of competitive products and pricing; risks and uncertainties associated with the safety and effectiveness of our technology; 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.
SOURCE QLT Inc.
