NOVELION THERAPEUTICS INC 
By Increases 2009 Guidance for Eligard(R) Sales and Adjusted EBITDA
"We are pleased to report another strong financial quarter, with robust Eligard(R) sales of
"We remain very focused on the development of our punctal plug program and continue to make innovative advancements to our proprietary platform. As separately announced, we released this morning data from our Phase II study investigating a high dose of latanaprost, 44 (micro)g, in addition to the retention rates of our proprietary plugs. We continue to strongly believe in the potential of our punctal plug delivery technology for broad use in ocular diseases."
2009 SECOND QUARTER FINANCIAL RESULTS
Worldwide Product Sales
Visudyne sales for the second quarter were
Worldwide Eligard sales in the second quarter were
QLT Revenues
For the second quarter, total revenue of
QLT Expenses
For the second quarter of 2009, Research and Development (R D) expense was
Operating Income/Loss
Operating income for the second quarter was
Earnings Per Share (EPS)/Loss Per Share
EPS of
In the second quarter, non-GAAP EPS was
Cash and Short-Term Investments
The Company's consolidated cash and cash equivalents balance at
Guidance Update
Based on strong first half results, we are raising our guidance for full year Eligard sales to
RECENT COMPANY ANNOUNCEMENTS
* Announced interim data from an ongoing Phase II clinical trial and a device study for the punctal plug delivery system. Preliminary interim results from the ongoing Phase II clinical trial of the 44-(micro)g Latanoprost Punctal Plug Delivery System (L-PPDS) show that the mean reduction in intraocular pressure (IOP) from baseline was 3.5 mmHg at the Week 4 visit with 36% of patients having an IOP decrease from baseline (greater than or equal to) 5 mmHg. The 44-(micro)g L-PPDS employs an early, proprietary punctal plug prototype, and based on a review of the preliminary data, it was well tolerated. Concurrent with the Phase II clinical trial, punctal plug prototype designs for the sustained delivery system are being tested in an ongoing multicenter study in more than 500 healthy volunteers. Based on currently available data, preliminary results for one family of designs show an overall retention rate of 75% after eight weeks of follow-up.
* Announced 12-month primary analysis results from the Novartis-sponsored Phase II MONT BLANC study which was presented on
* Announced 12-month primary analysis results from the Phase II RADICAL study (Reduced Fluence Visudyne Anti-VEGF-Dexamethasone In Combination for AMD Lesions) in patients with wet AMD. The purpose of the study is to determine if Visudyne combined with Lucentis reduces retreatment rates compared with Lucentis monotherapy, while maintaining similar vision outcomes and an acceptable safety profile. Three Visudyne-Lucentis combination therapies were evaluated against Lucentis monotherapy. The overall results showed that fewer retreatment visits were required with the combination therapies than with Lucentis monotherapy, and the differences were statistically significant. The visual acuity results do not permit determining whether the vision outcomes with combination therapy are superior, the same, or inferior to the monotherapy regimen given in this study.
* Announced that on
Conference call information
QLT Inc. will hold an investor conference call to discuss second 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
-----------------------------------------------
(In thousands of United Three months ended Six months ended
States dollars, except June 30, June 30,
per share information) 2009 2008 2009 2008
-------------------------------------------------------------------------
(Unaudited)
Revenues
Net product revenue $ 19,959 $ 22,517 $ 40,775 $ 42,533
Royalties 12,678 7,736 21,585 14,037
Licensing, milestones
and other 367 368 735 745
-------------------------------------------------------------------------
33,004 30,621 63,095 57,315
-------------------------------------------------------------------------
Costs and expenses
Cost of sales(1) 16,637 14,148 29,636 25,905
Research and development 7,225 8,114 13,111 16,162
Selling, general
and administrative 4,540 4,882 9,742 12,046
Depreciation 354 1,080 697 2,101
Litigation - 864 334 864
Restructuring (33) 1,872 (156) 9,471
-------------------------------------------------------------------------
28,723 30,960 53,364 66,549
-------------------------------------------------------------------------
Operating income (loss) 4,281 (339) 9,731 (9,234)
Investment and other
income (expense)
Net foreign exchange
gains (losses) 6,726 (17) 6,775 237
Interest income 588 1,619 1,965 3,936
Interest expense (345) (3,040) (1,848) (6,068)
Other (40) 109 24 262
-------------------------------------------------------------------------
6,929 (1,329) 6,916 (1,633)
-------------------------------------------------------------------------
Income (loss) from continuing
operations before income taxes 11,210 (1,668) 16,647 (10,867)
Provision for income taxes (2,581) (1,066) (6,716) (902)
-------------------------------------------------------------------------
Income (loss) from
continuing operations 8,629 (2,734) 9,931 (11,769)
-------------------------------------------------------------------------
Loss from discontinued
operations, net of
income taxes - (4,704) - (6,140)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Net income (loss) $ 8,629 $ (7,438) $ 9,931 $ (17,909)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic net income (loss)
per common share
Continuing operations $ 0.16 $ (0.04) $ 0.17 $ (0.16)
Discontinued operations - (0.06) - (0.08)
-------------------------------------------------------------------------
Net income (loss) $ 0.16 $ (0.10) $ 0.17 $ (0.24)
Diluted net income (loss)
per common share
Continuing operations $ 0.16 $ (0.04) $ 0.17 $ (0.16)
Discontinued operations - (0.06) - (0.08)
-------------------------------------------------------------------------
Net income (loss) $ 0.16 $ (0.10) $ 0.17 $ (0.24)
Weighted average number of
common shares outstanding
(in thousands)
Basic 54,620 74,620 57,954 74,620
Diluted 54,620 74,620 57,954 74,620
-------------------------------------------------------------------------
(1) Includes amount accrued on Visudyne sales pursuant to judgment
rendered in the MEEI litigation.
QLT Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
-------------------------------------
(In accordance with United States generally accepted accounting
principles)
June 30, December 31,
(In thousands of United States dollars) 2009 2008
-------------------------------------------------------------------------
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents $ 134,927 $ 165,395
Restricted cash - 124,578
Accounts receivable 26,406 31,096
Income taxes receivable 48,092 50,899
Inventories 16,426 11,633
Current portion of deferred income tax assets 10,137 9,835
Other 6,950 11,144
-------------------------------------------------------------------------
242,938 404,580
-------------------------------------------------------------------------
Property, plant and equipment 2,453 3,184
Deferred income tax assets 28,059 30,216
Goodwill 23,145 23,145
Mortgage receivable 10,325 9,834
Long-term inventories and other assets 17,072 20,799
-------------------------------------------------------------------------
$ 323,992 $ 491,758
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LIABILITIES
Current liabilities
Accounts payable $ 8,194 $ 9,115
Accrued restructuring charge 139 726
Accrued liabilities 4,004 129,512
Current portion of deferred revenue 6,051 5,673
-------------------------------------------------------------------------
18,388 145,026
Uncertain tax position liabilities 2,584 2,033
Deferred revenue 735 1,469
-------------------------------------------------------------------------
21,707 148,528
-------------------------------------------------------------------------
SHAREHOLDERS' EQUITY
Common shares 514,009 702,221
Additional paid-in capital 268,477 123,367
Accumulated deficit (569,633) (579,564)
Accumulated other comprehensive income 89,432 97,206
-------------------------------------------------------------------------
302,285 343,230
-------------------------------------------------------------------------
$ 323,992 $ 491,758
-------------------------------------------------------------------------
-------------------------------------------------------------------------
As at June 30, 2009, there were 54,620,328 issued and outstanding common
shares and 5,942,226 outstanding stock options.
QLT Inc.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
----------------------------------------------
2009 Second Quarter Reconciliation of GAAP Earnings to
Adjusted Non-GAAP Earnings Exhibit 1
-------------------------------------------------------------------------
Three months Three months
(In millions of United ended ended
States dollars, except June 30, 2009 June 30, 2009
per share information) GAAP Adjustments Non-GAAP(1)
-------------------------------------------------------------------------
(Unaudited)
Revenues
Net product revenue $ 20.0 $ - $ 20.0
Royalties 12.7 (2.2) (a) 10.5
Licensing, milestones
and other 0.4 (0.4) (b) -
-------------------------------------------------------------------------
33.0 (2.5) 30.5
-------------------------------------------------------------------------
Cost and expenses
Cost of sales (16.6) 4.6 (c)(d) (12.0)
Research and development (7.2) 0.3 (d) (7.0)
Selling, general and
administrative (4.5) 0.3 (d) (4.3)
Depreciation (0.4) - (0.4)
Litigation - - -
Restructuring 0.0 (0.0) (e) -
-------------------------------------------------------------------------
(28.7) 5.2 (23.6)
-------------------------------------------------------------------------
Operating income 4.3 2.6 6.9
Investment and other income
(expense)
Net foreign exchange gains 6.7 (8.0) (f) (1.2)
Interest income 0.6 (0.3) (g) 0.3
Interest expense (0.3) - (0.3)
Other (0.0) - (0.0)
-------------------------------------------------------------------------
6.9 (8.3) (1.3)
-------------------------------------------------------------------------
Income before income taxes 11.2 (5.6) 5.6
Provision for income taxes (2.6) 1.2 (h) (1.4)
-------------------------------------------------------------------------
Net income $ 8.6 $ (4.4) $ 4.2
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Income per common share:
Basic $ 0.16 $ 0.08
Diluted 0.16 0.08
Weighted average number of
common shares outstanding
(in millions):
Basic 54.6 54.6
Diluted 54.6 54.6
Adjustments:
------------
(a) Remove royalty revenue related to reversal of a provision for a
potential retroactive pricing rebate on certain sales of Eligard
from 2004 to 2008.
(b) Remove licensing and milestone revenue.
(c) Remove inventory write-down.
(d) Remove stock-based compensation.
(e) Remove restructuring credit.
(f) Remove foreign exchange gains related to intercompany debt.
(g) Remove interest income related to income tax refund.
(h) 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.
QLT Inc.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
----------------------------------------------
2009 Second Quarter Reconciliation of GAAP Earnings to
Adjusted Non-GAAP Earnings Exhibit 2
-------------------------------------------------------------------------
Six months Six months
(In millions of United ended ended
States dollars, except June 30, 2009 June 30, 2009
per share information) GAAP Adjustments Non-GAAP(1)
-------------------------------------------------------------------------
(Unaudited)
Revenues
Net product revenue $ 40.8 $ - $ 40.8
Royalties 21.6 (2.2) (a) 19.4
Licensing, milestones
and other 0.7 (0.7) (b) -
-------------------------------------------------------------------------
63.1 (2.9) 60.2
-------------------------------------------------------------------------
Cost and expenses
Cost of sales (29.6) 4.7 (c)(d) (25.0)
Research and development (13.1) 0.5 (d) (12.6)
Selling, general and
administrative (9.7) 0.6 (d) (9.1)
Depreciation (0.7) - (0.7)
Litigation (0.3) 0.3 (e) -
Restructuring 0.2 (0.2) (f) -
-------------------------------------------------------------------------
(53.4) 5.9 (47.4)
-------------------------------------------------------------------------
Operating income 9.7 3.0 12.8
Investment and other income
(expense)
Net foreign exchange gains 6.8 (8.0) (g) (1.2)
Interest income 2.0 (1.0) (h) 0.9
Interest expense (1.8) - (1.8)
Other 0.0 - 0.0
-------------------------------------------------------------------------
6.9 (9.0) (2.1)
-------------------------------------------------------------------------
Income before income taxes 16.6 (5.9) 10.7
Provision for income taxes (6.7) 1.4 (i) (5.3)
-------------------------------------------------------------------------
Net income $ 9.9 $ (4.5) $ 5.4
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Income per common share:
Basic $ 0.17 $ 0.09
Diluted 0.17 0.09
Weighted average number of
common shares outstanding
(in millions):
Basic 58.0 58.0
Diluted 58.0 58.0
Adjustments:
------------
(a) Remove royalty revenue related to reversal of a provision for a
potential retroactive pricing rebate on certain sales of Eligard
from 2004 to 2008.
(b) Remove licensing and milestone revenue.
(c) Remove inventory write-down.
(d) Remove stock-based compensation.
(e) Remove litigation expense.
(f) Remove restructuring credit.
(g) Remove foreign exchange gains related to intercompany debt.
(h) Remove interest income related to income tax refund.
(i) 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.
Lucentis is a registered trademark of Genentech, Inc.
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 punctal plug studies; our expectations for timing to receive results relating to our Visudyne RADICAL combination study and the Novartis sponsored MONT BLANC 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 sand 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.
