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| QLTI > SEC Filings for QLTI > Form 10-Q on 5-May-2009 | All Recent SEC Filings |
5-May-2009
Quarterly Report
Revenues
Net Product Revenue
Net product revenue was determined as follows:
Three months ended
March 31,
(In thousands of U.S. dollars) 2009 2008
Visudyne sales by Novartis $ 27,754 $ 36,480
Less: Marketing and distribution costs(1) (8,687 ) (18,032 )
Less: Inventory costs(2) (1,656 ) (1,989 )
Less: Royalties to third parties(3) (602 ) (779 )
$ 16,809 $ 15,680
QLT's 50% share of Novartis' net proceeds from
Visudyne sales $ 8,404 $ 7,840
Add: Advance on inventory costs from Novartis(4) 1,943 1,355
Add: Royalties reimbursed to QLT(5) 612 797
Add: Other costs reimbursed to QLT(6) 820 1,912
Revenue from Visudyne sales $ 11,779 $ 11,904
Net product revenue from Eligard 9,038 8,112
$ 20,817 $ 20,016
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(1) "Less:
Marketing and
distribution
costs"
This
represents
Novartis' cost
of marketing,
promoting, and
distributing
Visudyne, as
well as
certain
specified
costs incurred
and paid for
by QLT,
determined in
accordance
with the PDT
Product
Development,
Manufacturing,
and
Distribution
Agreement
between QLT
and Novartis.
The costs
incurred by
Novartis are
related to its
sales force,
advertising
expenses,
marketing, and
certain
administrative
overhead
costs. The
costs incurred
by us include
marketing
support, legal
and
administrative
expenses that
we incur in
support of
Visudyne
sales.
(2) "Less:
Inventory
costs"
This
represents
Novartis' cost
of goods sold
related to
Visudyne. It
includes the
cost of bulk
Visudyne we
ship to
Novartis and
our provisions
for excess or
obsolete
inventory,
losses on
manufacturing
purchase
commitments,
plus Novartis'
packaging and
labelling
costs,
freight,
custom duties
and inventory
obsolescence.
(3) "Less:
Royalties to
third parties"
This
represents the
royalty
expenses we
incur and
charge to
Novartis
pursuant to
the PDT
Product
Development,
Manufacturing
and
Distribution
Agreement
between QLT
and Novartis.
The amounts
are calculated
by us based on
specified
royalty rates
from existing
license
agreements
with our
licensors of
certain
Visudyne
patent rights.
(4) "Add: Advance on inventory costs from Novartis"
This
represents the
amount that
Novartis
advances to us
for shipments
of bulk
Visudyne and
reimbursement
for inventory
obsolescence.
The price of
the Visudyne
shipments is
determined
based on the
existing
agreement
between QLT
and Novartis
and represents
our actual
costs of
producing
Visudyne.
(5) "Add:
Royalties
reimbursed to
QLT"
This is
related to
item (3) above
and represents
the amounts we
receive from
Novartis in
reimbursement
for the actual
royalty
expenses we
owe to third
party
licensors.
(6) "Add: Other costs reimbursed to QLT"
This
represents
reimbursement
by Novartis to
us of our
portion of the
marketing and
distribution
costs
described in
(1) above. Our
marketing and
distribution
costs include
marketing
support, legal
and
administrative
expenses that
we incur in
support of
Visudyne
sales.
For the three months ended March 31, 2009, revenue from Visudyne declined by
$0.1 million, or 1%, to $11.8 million compared to $11.9 million for the three
months ended March 31, 2008. The decrease was due to a 24% decline in Visudyne
sales by Novartis over the same period in the prior year as a result of
decreased end user demand due to competing therapies, offset by a 52% reduction
in marketing and distribution costs. For the three months ended March 31, 2009,
approximately 31% of the total Visudyne sales by Novartis were in the U.S., 25%
were in Europe, and 44% were in other markets worldwide. For the three months
ended March 31, 2008, approximately 25% of the total Visudyne sales by Novartis
were in the United States, 36% were in Europe, and 39% were in other markets
worldwide. Overall, the ratio of our 50% share of Novartis' net proceeds from
Visudyne sales compared to total worldwide Visudyne sales was 30.3% for the
three months ended March 31, 2009, up from 21.5% for the three months ended
March 31, 2008.
For the three months ended March 31, 2009, net product revenue from Eligard
increased by $0.9 million, or 11%, to $9.0 million, from $8.1 million for the
three months ended March 31, 2008. The increase was due to increased shipments
of Eligard to commercial licensees, which was driven by Eligard's continued
growth in Europe and the U.S.
Royalties
For the three months ended March 31, 2009, royalty revenue was $8.9 million,
which was $2.6 million, or 41% higher than royalty revenue of $5.7 million for
the same period in 2008. The increase is partially a result of a $1.8 million
provision for a potential retroactive pricing rebate on certain sales of Eligard
recorded in the three months ended March 31, 2008. The remaining increase is a
result of Eligard's continued growth in Europe and the U.S..
Costs and Expenses
Cost of Sales
For the three months ended March 31, 2009, cost of sales increased by 11% to
$13.0 million compared to $11.8 million for the same period in 2008. The
increase was mainly due to higher shipments of Eligard to our commercial
licensees. Cost of sales related to Eligard increased from $8.5 million to
$9.6 million in the three months ended March 31, 2009 compared to the same
period in 2008. The increase was due to continued growth of the product in
Europe and the U.S..
Costs of sales related to Visudyne increased from $3.3 million to $3.4 million
in the quarter ended March 31, 2009 compared to the same period in 2008. The
current period cost of sales related to Visudyne includes a $0.4 million charge
for a loss on a minimum manufacturing purchase commitment and $0.6 million
charge for an inventory write-down. Cost of sales related to Visudyne for both
periods included 3.01% of worldwide Visudyne sales, pursuant to damages awarded
in the judgment against us in the MEEI litigation. See Note 12(b) Contingencies
in the "Notes to Condensed Consolidated Financial Statements" in this report.
Unless the judgment is reversed or altered upon further appellate review, QLT
will be required to continue to pay MEEI 3.01% of worldwide Visudyne net sales,
and this amount will be reported in cost of sales. We are in communication with
Novartis about sharing in the cost of the judgment and the ongoing obligation.
However, there is no guarantee that they will agree to participate.
Research and Development
Research and development, or R&D, expenditures decreased 27% to $5.9 million for
the three months ended March 31, 2009 compared to $8.0 million in the same
period in 2008. The decrease was a result of lower overhead expenses due to cost
savings from restructuring and lower spending on Visudyne combination studies,
partially offset by higher spending on punctal plug development.
The magnitude of future R&D expenses is highly variable and depends on many
factors over which we have limited visibility and control. Numerous events can
happen to an R&D project prior to it reaching any particular milestone which can
significantly affect future spending and activities related to the project.
These events include:
• inability to design punctal plugs to function as expected,
• delays or inability to formulate active ingredient in right concentration to deliver effective doses of drug,
• changes in the regulatory environment,
• introduction of competing technologies and treatments,
• unexpected safety issues,
• patent application, maintenance and enforcement issues,
• inability to operate without infringing the proprietary rights of others,
• changes in the commercial marketplace,
• difficulties in enrolling patients into or keeping them in our clinical studies,
• delays in study progression, including study site, Institutional Review Board and regulatory delays,
• failure to meet favorable study endpoints,
• inability to develop cost effective manufacturing methods that comply with regulatory standards,
• inability to attract personnel or retain personnel with expertise required by our development program,
• inability to manufacture sterile supplies necessary for composition of products,
• uncertainties related to collaborative arrangements,
• environmental risks, and
• other factors referenced under Item 1A, Risk Factors.
R&D expenditures by therapeutic area were as follows:
Three months ended
March 31,
(In thousands of U.S. dollars) 2009 2008
Ocular $ 5,712 $ 6,708
Dermatology 10 1,274
Other 164 66
$ 5,886 $ 8,048
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Selling, General and Administrative Expenses
For the three months ended March 31, 2009, selling, general and administrative,
or SG&A, expenses decreased 27% to $5.2 million compared to $7.2 million for the
three months ended March 31, 2008. The decrease was primarily due to cost
savings from restructuring and higher Visudyne production in the three months
ended March 31, 2009 compared to the same period in 2008, which resulted in an
increased allocation of costs to manufacturing under our standard costing
system.
Litigation
During the three months ended March 31, 2009, we incurred a charge of
approximately $0.3 million in connection with the reimbursement of legal fees,
accounting fees and other amounts to resolve legal issues not material to QLT or
its business.
Restructuring Charge
During the three months ended March 31, 2008, we restructured our operations and
during the three months ended March 31, 2009, we recorded a $0.1 million
adjustment to our restructuring accrual related to severance, termination
benefits and other costs as we complete final activities associated with this
restructuring. For the three months ended March 31, 2008, we provided most of
the approximately 115 affected employees with severance and support to assist
with outplacement and recorded $7.6 million of restructuring charges which
included a property, plant, and equipment impairment charge of $1.5 million.
Annualized operating savings as a result of the 2008 restructuring, which was
substantially completed by June 30, 2008, are approximately $11.0 million.
Investment and Other Income (Expense)
Net Foreign Exchange Gains
Net foreign exchange gains comprise gains from the impact of foreign exchange
fluctuations on our cash and cash equivalents, restricted cash, derivative
financial instruments, foreign currency receivables, foreign currency payables
and, prior to its redemption in September 2008, U.S. dollar denominated
convertible debt. See "Liquidity and Capital Resources - Interest and Foreign
Exchange Rates."
Details of our net foreign exchange gains were as follows:
Three months ended
March 31,
(In thousands of U.S. dollars) 2009 2008
Cash and cash equivalents $ 2,501 $ 1,902
Restricted cash 2,622 3,246
U.S. dollar convertible debt - (4,585 )
Foreign exchange contracts 1,108 2,059
Foreign currency receivables and payables (6,182 ) (2,368 )
Net foreign exchange gains $ 49 $ 254
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Interest Income
For the three months ended March 31, 2009, interest income decreased 41% to
$1.4 million compared to $2.3 million for the same period in 2008. The decrease
was primarily due to a substantial decline in interest rates partially offset by
$0.7 million of interest earned on tax refunds, $0.2 million of interest earned
on our second mortgage financing and a higher average cash balance compared to
the same period in the prior year.
Interest Expense
Interest expense of $1.5 million for the three month period ended March 31, 2009
is entirely related to interest expense on the post judgment accrued liability
associated with the MEEI patent litigation damage award. For the three months
ended March 31, 2008, $3.0 million of interest expense comprised $1.3 million of
interest accrued on the 3% convertible senior notes due in 2023 (which were
redeemed on September 15, 2008), $0.3 million of amortization of deferred
financing expenses related to the placement of these notes and interest expense
of $1.4 million on the post judgment accrued liability associated with the MEEI
patent litigation damage award.
Loss from Discontinued Operations
During the third quarter of 2008, we completed the sale of Aczone and
out-license of certain Atrigel rights. In accordance with SFAS No. 144,
Accounting for the Impairment or Disposal of Long-lived Assets, the results of
operations from the Aczone and Atrigel products were excluded from continuing
operations and reported as discontinued operations for the prior period.
Income Taxes
The effective income tax rate for the three month period ended March 31, 2009
was 76.1% compared to 1.8% for the same period in the prior year. The increase
in the effective tax rate was primarily due to an increased valuation allowance
against the tax benefit of losses associated with punctal plug development
expenditures and changes in the overall mix of income (loss) in the
jurisdictions in which we operate and it reflects the impact of a corporate
reorganization and the outcome of items currently outstanding with tax
authorities.
LIQUIDITY AND CAPITAL RESOURCES
General
Our cash resources and working capital, cash flow from operations, and other
available financing resources will be utilized to fund current product
development programs, operating requirements, and liability requirements.
We are continuing to pursue the sale of QLT USA or its remaining assets,
principally the Eligard product line and related assets, but such a transaction
will not be completed if we are unable to sell it on terms, including price that
are satisfactory to us. If adequate capital is not available, our business could
be materially and adversely affected. Other factors that may affect our future
capital requirements include: the status of competitors and their intellectual
property rights; the outcome of legal proceedings and damage awards; the
progress of our R&D programs, including preclinical and clinical testing;
potential future share repurchases; fluctuating or increasing manufacturing
requirements; the timing and cost of obtaining regulatory approvals; the levels
of resources that we devote to the development of manufacturing, and other
support capabilities; technological advances; the cost of filing, prosecuting
and enforcing our patent claims and other intellectual property rights; and our
ability to establish collaborative arrangements with other organizations.
On April 15, 2009, the District Court issued an order releasing the appeal bond
that we had posted in August 2007 and directed the bonding company to pay out
the bond amount to MEEI. The District Court order also entered a judgment
ordering us to pay MEEI $14.1 million in attorneys' fees and costs to MEEI, to
which a reduction of $3.0 million previously agreed to by MEEI was applied. On
April 23, 2009, the appeal bond amount of $124.8 million was released to MEEI,
and we paid MEEI an additional $2.2 million to satisfy the difference between
the District Court judgment, plus attorneys' fees and interest, and the amount
held by the bonding company. We are in communication with Novartis about sharing
in the cost of the judgment and the ongoing obligation. However, there is no
guarantee that they will agree to participate.
Sources and Uses of Cash
We have financed operations, product development and capital expenditures
primarily through proceeds from our commercial operations, public and private
sales of equity securities, private placement of convertible senior notes,
licensing and collaborative funding arrangements, sale of non-core assets and
interest income.
The primary drivers of our operating cash flows during the three month period
ended March 31, 2009 were cash payments related to the following: R&D
activities, SG&A expenses, raw material purchases, manufacturing costs related
to the production of Eligard, tax installments, and interest expense, offset by
cash receipts from product revenues, royalties and milestone payment, interest
income and a tax refund.
For the three month period ended March 31, 2009, we generated $17.6 million of
cash from operations as compared to using $6.2 million for the same period in
2008. The $23.8 million positive cash flow variance is primarily attributable
to:
• A positive cash flow variance from higher cash receipts from product
sales, royalties and milestones of $7.5 million;
• A positive cash flow variance from lower operating and inventory related expenditures of $7.2 million;
• A positive cash flow variance from lower restructuring costs of $3.9 million;
• A positive cash flow variance from a tax refund of $2.9 million;
• A positive cash flow variance from higher foreign exchange gains of $2.6 million;
• A positive cash flow variance from higher investment and other income of $2.3 million; and
• A negative cash flow variance from tax installments of $1.7 million.
During the three month period ended March 31, 2009, the disposal of fixed assets
of $0.1 million accounted for the most significant cash flows provided by
investing activities offset by capital expenditures of $0.1 million.
For the three month period ended March 31, 2009, our cash flows used in
financing activities consisted primarily of common shares repurchased, including
share repurchase costs, of $51.9 million.
Interest and Foreign Exchange Rates
We are exposed to market risk related to changes in interest and foreign
currency exchange rates, each of which could adversely affect the value of our
current assets and liabilities. At March 31, 2009, we had $130.1 million in cash
and cash equivalents. Approximately $106.1 million, or 82%, of the cash and cash
equivalents was held in two U.S. Government money market funds that have
maintained their net asset values and applied for coverage under the U.S.
Treasury Department's Temporary Guarantee Program for Money Market Funds
(Guarantee Program). The remaining balance was held in cash and term deposits.
At March 31, 2009, our term deposits had an average remaining maturity of
15 days. If market interest rates were to increase immediately and uniformly by
one hundred basis points from levels at March 31, 2009, the fair value of the
term deposits would decline by an immaterial amount due to the short remaining
maturity period. Since the remaining cash and cash equivalents were all held in
money market funds and cash, changes in market interest rates do not impact
their fair value.
To offset the foreign exchange impact of our U.S. dollar-denominated
liabilities, we held approximately the equivalent amount in U.S.
dollar-denominated cash, restricted cash, cash equivalents, accounts receivables
and foreign currency contracts such that if the U.S. dollar were to increase in
value by 10% against the Canadian dollar, the increase in the fair value of our
U.S. dollar denominated liabilities would be approximately offset by the
increase in fair value of our U.S. dollar-denominated cash, restricted cash,
cash equivalents, accounts receivables and foreign currency contracts, resulting
in an immaterial amount of unrealized foreign currency translation loss. As the
functional currency of our U.S. subsidiaries is the U.S. dollar, the U.S.
dollar-denominated cash and cash equivalents holdings of our U.S. subsidiaries
do not result in foreign currency gains or losses in operations. The Canadian
dollar is the functional currency of QLT Inc., while the U.S. dollar is our
reporting currency. Since QLT Inc. holds a portion of its cash and cash
equivalents in its functional currency, the Canadian dollar, we are subject to
translation gains and losses. These translation gains and losses are included as
part of the cumulative foreign currency translation adjustment, which is
reported as a component of shareholders' equity under accumulated other
comprehensive income.
We enter into foreign exchange contracts to manage exposures to currency rate
fluctuations related to our U.S. dollar-denominated liabilities. The net
unrealized gain in respect of such foreign currency contracts for the three
months ended March 31, 2009 was $0.8 million, and was included as part of the
net foreign exchange gains in our results of operations.
At March 31, 2009, we had outstanding forward foreign currency contracts as
noted below.
Maturity Period Quantity (millions) Average Price
CAD / USD
forward contracts to buy USD 2009 USD 73.0 1.24615 per USD
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Contractual Obligations
Our material contractual obligations as of March 31, 2009 comprised our supply
agreements with contract manufacturers, and clinical and development agreements.
We also have operating lease commitments for office space and office equipment.
Details of these contractual obligations are described in our Annual Report on
Form 10-K for the year ended December 31, 2008.
Off-Balance Sheet Arrangements . . .
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