QLT Inc. Reports Operating Results (10-Q)

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Nov 06, 2009
QLT Inc. (QLTI, Financial) filed Quarterly Report for the period ended 2009-09-30.

QLT PhotoTherapeutics Inc. is a world leader in the development and commercialization of proprietary pharmaceutical products for use in photodynamic therapy an emerging field of medicine utilizing light-activated drugs in the treatment of disease. QLT's innovative science has advanced photodynamic therapy beyond applications in cancer towards potential breakthrough treatments in ophthalmology and autoimmune disease. (PRESS RELEASE) Qlt Inc. has a market cap of $194.4 million; its shares were traded at around $3.56 with a P/E ratio of 16.9 and P/S ratio of 1.6.

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On October 16, 2009, we entered into an Amended and Restated PDT Product Development, Manufacturing and Distribution Agreement (the Amended PDT Agreement) with Novartis. Under the Amended PDT Agreement, effective January 1, 2010, we will, among other things, receive exclusive U.S. rights to the Visudyne® patents to sell and market Visudyne in the U.S. Under the Amended PDT Agreement, we will have exclusive U.S. sales and marketing rights to Visudyne, including rights to all end-user revenue derived from Visudyne sales in the U.S. Novartis will have marketing and sales rights in all countries outside of the U.S. (ex-US) and will pay QLT a royalty of 20% of ex-US net sales until December 31, 2014, and thereafter 16% of ex-US net sales until the expiry of the Amended PDT Agreement on December 31, 2019. We will continue to manufacture Visudyne and will supply the product at a pre-specified price exclusively to Novartis for ex-US distribution. QLT and Novartis will each be responsible for all costs and expenses associated with marketing and sales in their respective territories. Also under the Amended PDT Agreement, QLT and Novartis have released each other from all open claims the parties may have against each other, including any in connection with QLTs litigation with MEEI and QLTs litigation with MGH.

For the three months ended September 30, 2009, revenue from Visudyne sales of $8.8 million decreased by $2.1 million, or 19.2%, from the three months ended September 30, 2008. The decrease was primarily due to a 31.1% decline in Visudyne sales by Novartis over the same quarter in the prior year as a result of decreased end user demand due to competing therapies, offset by a 48.6% reduction in marketing and distribution costs. In the third quarter of 2009, approximately 26% of the total Visudyne sales by Novartis were in the U.S., 28% were in Europe, and 46% were in other markets worldwide. For the third quarter of 2008, approximately 27% of the total Visudyne sales by Novartis were in the U.S., 29% were in Europe, and 44% 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 28.9% in the third quarter of 2009, up from 22.6% in the third quarter of 2008.

For the nine months ended September 30, 2009, revenue from Visudyne sales of $31.3 million decreased by $5.2 million, or 14.2%, from the nine months ended September 30, 2008. The decrease was primarily due to a 27.9% 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 50.5% reduction in marketing and distribution costs. In the nine months ended September 30, 2009, approximately 29% of the total Visudyne sales by Novartis were in the U.S., 27% were in Europe, and 44% were in other markets worldwide. In the nine months ended September 30, 2008, approximately 26% of the total Visudyne sales by Novartis were in the U.S., 34% were in Europe, and 40% 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 30.2% in the nine months ended September 30, 2009, up from 22.4% in the nine months ended September 30, 2008.

For the three months ended September 30, 2009, cost of sales of $2.2 million decreased $0.8 million, or 26.3%, compared to $3.0 million for the same period in 2008. The decrease in cost of sales was related to the drop in Visudyne sales for the three month period. For the nine months ended September 30, 2009, cost of sales of $12.7 million increased $2.0 million, or 19.0%, compared to $10.7 million for the same period in the prior year. The increase was mainly due to a $4.6 million inventory write-down related to Visudyne recorded in the second quarter of 2009, offset by lower cost of sales related to the drop in Visudyne sales. Inventory quantities are regularly reviewed and provisions for excess or obsolete inventory are recorded primarily based on our forecast of future demand and market conditions. During the nine months ended September 30, 2009, we concluded that based on our forecast of future Visudyne demand, certain early stage materials used in the manufacture of Visudyne were potential excess inventory. As a result, we provided a reserve against the excess inventory and in the second quarter of 2009, recorded a charge of $4.6 million in cost of sales.

Cost of sales related to Visudyne included 3.01% of worldwide Visudyne net sales, pursuant to damages awarded in the judgment against us in the MEEI litigation. See Note 12 Contingencies in the Notes to Unaudited Condensed Consolidated Financial Statements in this report. We are required to continue to pay MEEI 3.01% of worldwide Visudyne net sales, and this amount is reported in cost of sales. On October 16, 2009, we entered into an Amended and Restated PDT Product Development, Manufacturing and Distribution Agreement with Novartis. Under the Amended PDT Agreement, QLT and Novartis have released each other from all open claims the parties may have against each other, including any in connection with QLTs litigation with MEEI and QLTs litigation with MGH. No reimbursement has been or will be received for the damages paid to MEEI in the amount of 3.01% of worldwide Visudyne net sales.

For the three months ended September 30, 2009, research and development, or R&D, expenditures increased 7.1% to $7.4 million compared to $6.9 million in the same period in 2008. The increase was a result of higher spending on the punctal plug program which more than offset a decline in Visudyne R&D. For the nine months ended September 30, 2009, R&D decreased 11.1% to $20.5 million compared to $23.0 million for the same period in 2008. The decrease was a result of lower overhead expenses due to cost savings from restructuring, lower spending on Visudyne combination studies and Lemuteporfin, partially offset by higher spending on punctal plug development.

Read the The complete ReportQLTI is in the portfolios of Charles Brandes of Brandes Investment, Arnold Van Den Berg of Century Management.