(Source: Canada Newswire)

QLT SEPARATELY ANNOUNCES SHARE REPURCHASE PROGRAM
VANCOUVER, Oct. 27 /CNW/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT)
("QLT" or the "Company") today reported financial results for the
third quarter ended September 30, 2009. Unless specified otherwise,
all amounts are in U.S. dollars and in accordance with U.S. GAAP.
"Our recently announced accomplishments mark a significant
turning point for the Company, as we have fulfilled our vision of
becoming a company focused solely in the ocular therapeutic area and
will soon have a commercial presence in the U.S.," said Bob
Butchofsky, President and Chief Executive Officer of QLT. "We are
looking forward to advancing the punctal plug drug delivery platform
and expect to report additional data in the first quarter next
year."
2009 THIRD QUARTER FINANCIAL RESULTS
Financial Reporting
For the third quarter and nine months ended September 30, 2009,
QLT is reporting the results of our divested QLT USA business as one
line item called Income from Discontinued Operations on our
statements of operations. This item captures in one line the net
results of the entire QLT USA operation through September 30, 2009.
Worldwide Product Sales
Worldwide Visudyne(R) sales for the third quarter were $23.5
million, a decrease of 31.1% from sales in the third quarter of
2008. Sales in the U.S. were $6.2 million, down 32.5% from the prior-
year third quarter, while sales outside the U.S. were $17.3 million,
down 30.5% from the prior year. Worldwide Eligard(R) sales in the
third quarter were $65.0 million, an increase of 18.8% over the
third quarter of 2008. U.S. sales of $18.8 million were up 11.4%
from last year, while sales outside the U.S. increased 22.1% to
$46.1 million. All revenue items related to the Eligard product are
included in the Income from Discontinued Operations line on the
statements of operations.
QLT Revenues
Revenue is now comprised solely of revenue from Visudyne. For the
third quarter, revenue of $8.8 million was down 19.2% from the third
quarter of 2008 due primarily to the decrease in end-user Visudyne
sales. QLT's share of profit from Visudyne sales was 28.9% in the
quarter, up from 22.6% in the third quarter of 2008.
QLT Expenses
For the third quarter of 2009, Research and Development (R&D)
expense was $7.4 million, up from $6.9 million in the same period of
2008 primarily due to increased spending on the punctal plug
program. Selling, General and Administrative (SG&A) expense was $4.5
million, up slightly from $4.4 million last year.
Operating Income/Loss
Operating loss for the third quarter was $6.0 million, compared
to operating income of $17.0 million in the prior-year third
quarter. Last year's income included a $21.3 million gain from the
sale of our corporate headquarters and surrounding land. Excluding
that gain, the operating loss increased from last year due to the
drop in Visudyne sales.
Earnings Per Share (EPS)/Loss Per Share
EPS of $0.16 in the third quarter compared to EPS of $1.97 in the
prior-year quarter. The decline occurred because the 2008 third
quarter results included a $134 million gain from the sale of
Aczone(R) and Atrigel(R) (within discontinued operations) and the
$21.3 million gain from the sale of our headquarters and land. In
the third quarter, non-GAAP loss per share was $0.08, significantly
lower than GAAP EPS primarily because the income from discontinued
operations and a non-cash foreign exchange gain related to an
intercompany loan were eliminated. A full reconciliation of GAAP to
non-GAAP EPS for the third quarter and nine months is provided in
Exhibits 1 and 2.
Cash and Short-Term Investments
The Company's consolidated cash and cash equivalents balance at
September 30, 2009 was $194.0 million, up from $134.9 million at the
end of the second quarter primarily due to collection of income tax
refunds during the quarter. The cash and cash equivalents balance at
September 30, 2009 did not include $20.0 million ($16.5 million net
of transaction fees) that was paid to us on October 1, 2009 as the
first installment of our sale of QLT USA.
2009 Guidance Update
- As previously announced, under the terms of our sale of QLT
USA, we
expect to be paid up to an additional $200 million in quarterly
payments equal to 80% of the royalties paid to QLT USA under the
Sanofi and Medigene agreements. As a result of this transaction:
- In the fourth quarter we expect to record a gain of over $100
million within income from discontinued operations related to the
accounting gain on the sale, which represents the excess of the
estimated present value of all consideration expected to be
received under the deal compared to the net book value of the net
assets that were sold.
- We will have an asset on the balance sheet called Contingent
Consideration, which represents the estimated present value of
the
expected remaining payments due from the $200 million of
quarterly
payments mentioned above.
- Cash collected each quarter will not be recorded as revenue,
rather it will draw down the Contingent Consideration asset on
the
balance sheet. In the fourth quarter we expect to collect
Contingent Consideration of approximately $8.4 million.
- Each period we will have to assess the fair value of the
Contingent Consideration and any changes will flow through the
P&L
as gains or losses within Other Income and Expense.
- Guidance for Eligard sales was increased in our last earnings
update
to $240-255 million. Given that we will no longer be reporting
any
revenue from Eligard sales on our statements of operations, we
are
discontinuing our guidance for end-user Eligard sales. However,
Eligard sales through the nine months ended September 30, 2009 of
$191.1 million were in line with the previous guidance.
- Guidance for R&D expense is $30-33 million and for SG&A
expense is
$18-21 million, unchanged from previous guidance, although we do
expect that both line items will be near the bottom end of the
guidance ranges.
- Guidance for adjusted EBITDA (defined as operating income
plus stock
compensation and depreciation expense and adjusted for other one-
time
and non-cash items) was increased in our last earnings call to
$15-20
million. As above, given that we will no longer be reporting
revenue
from Eligard, we are discontinuing guidance for adjusted EBITDA.
However, through the nine months ended September 30, 2009
adjusted
EBITDA (including EBITDA associated with our discontinued
operations)
was $18.3 million.
- The amendment to the Visudyne agreement does not take effect
until
January 1, 2010, and therefore there is not expected to be any
material impact to our 2009 operating results. Beginning in 2010,
QLT's revenue from Visudyne will comprise: (i) end-user net sales
of
Visudyne in the U.S., (ii) royalties in the amount of 20% of net
sales of Visudyne outside of the U.S., (iii) product revenue from
selling unlabelled Visudyne product to Novartis for its sale of
the
product outside of the U.S., and (iv) reimbursement from Novartis
for
the existing third party royalties we currently pay to University
of
British Columbia and Massachusetts General Hospital for sales of
Visudyne outside the U.S. (no reimbursement will be received for
the
ongoing damages paid to MEEI in the amount of 3.01% of Visudyne
sales).
In 2010, we will provide guidance on adjusted EBITDA plus the
quarterly payments due for the sale of QLT USA (calculated as 80% of
the Eligard royalty payments referenced above), because we believe
this to be a more reflective measure of our cash-flow for the next
several years.
RECENT COMPANY ANNOUNCEMENTS
- Announced the receipt of an income tax refund of Cdn$45.3
million
from the Canada Revenue Agency. The income tax refund resulted
primarily from a request to carryback losses the Company incurred
in
2007 in connection with the judgment of the United States
District
Court for the District of Massachusetts in favor of Massachusetts
Eye
and Ear Infirmary.
- Announced the sale of all of the shares of QLT's wholly-
owned U.S.
subsidiary, QLT USA, Inc. ("QLT USA"), to TOLMAR Holding, Inc.
("TOLMAR") for up to an aggregate US$230 million pursuant to a
Stock
Purchase Agreement dated October 1, 2009. QLT USA's principal
operating asset is the Eligard line of products for the treatment
of
prostate cancer. The Eligard line of products is currently
manufactured by TOLMAR, Inc., a wholly-owned subsidiary of
TOLMAR.
- Announced that QLT has restructured its agreement with
Novartis
Pharma AG to simplify the relationship, under which, effective
January 1, 2010, it will, among other things, receive exclusive
U.S.
rights to the Visudyne patents to sell and market Visudyne in the
U.S.
About QLT
QLT Inc. is a global biopharmaceutical company dedicated to the
discovery, development and commercialization of innovative ocular
therapies. We utilize two unique technology platforms, photodynamic
therapy (used in the Visudyne product) and punctal plugs which are
currently under development for future product opportunities. For
more information, visit our web site at www.qltinc.com.
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.