Call Start: 08:32
Call End: 09:07
QLT, Inc. (QLTI)
Q4 2011 Earnings Results Conference
February 23, 2012 8:30 am ET
Robert Butchofsky – President and CEO
Cameron Nelson – Vice President, Finance and Chief Financial Officer
Karen Peterson – Investor Relations Specialist
Doug Miehm - RBC Capital Markets
Scott Henry – Roth Capital Partners
Jason Aryeh - JALAA Equities, LP
Previous Statements by QLTI
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Hello. This is the Chorus Call conference operator. Welcome to the QLT Inc. Fourth Quarter and Year-End 2011 Conference Call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. (Operator Instructions)
At this time, I’d like to turn the conference over to Karen Peterson, Investor Relations Specialist. Please go ahead.
Good morning, everyone. And welcome to QLT’s fourth quarter and year-end 2011 earnings conference call. If you have not yet received a copy of our press release, you can find it by visiting our website at www.qltinc.com. The conference call is being webcast live and will be available on our website for the next 30 days.
Presenting today is Bob Butchofsky, our President and CEO; and Cameron Nelson, Senior Vice President and Chief Financial Officer. Before I turn the call over to Bob, let me review the Safe Harbor statement.
On behalf of the speakers who follow, we caution investors that certain statements in this conference call is forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and constitute forward-looking information within the meaning of Canadian Securities Laws. For the purposes of this caution, we refer to such statements as forward-looking statements.
Forward-looking statements are predictions only, which involve known and unknown risks and uncertainties and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements.
For additional information about the material factors or assumptions underlying such statements, and about the material factors that may cause actual results to vary from those expressed or implied in such statements, please consult our earnings press release sent out earlier this morning and available on our corporate website, as well as our filings with the U.S. Securities and Exchange Commission and the Canadian Securities regulatory authorities, including the risk factors detailed in the most recently filed annual report on Form 10-K and quarterly reports on Form 10-Q.
QLT undertakes no obligation to update such information to reflect later events or developments, except as required by law. This call also includes a discussion of non-GAAP financial measures as defined by applicable securities laws. The most directly comparable U.S. GAAP financial measures and the information reconciling these non-GAAP finance measures to QLT’s financial results prepared in accordance with U.S. GAAP have been included in the earnings press release issued earlier today and posted on our website.
And, with that, I’ll turn the call over to Bob.
All right. Thanks a lot, Karen. Good morning, everyone, and thank you for joining us on our fourth quarter and year-end 2011 conference call. I’m going to spend most of my time this morning highlighting updates or development pipeline starting first with review of the synthetic retinoid program, followed by our punctal plug delivery program and have a short discussion on Visudyne and the macular degeneration market.
Let’s start with QLT091001, our retinoid product for inherited retinal diseases. As most of you know the next milestone for the program as the upcoming data for the Retinitis Pigmentosa or RP Phase 1B trial, which we expect to have it you before the end of the current quarter. The QLT R&D Day we held in New York last December, I told you that based on higher than expected demand especially from the new treatment centers in both the U.S. and Europe that we were expanding the trial from the original target of 14 RP patients, up to a maximum of 20 RP patients.
We are now expecting to report top-line data in the first quarter on 17 subjects from the trial. And you should expect this will be a top-line preliminary endpoint summary release. We are expecting that a more detailed presentation of the results from the RP trial will be made in the second quarter this year. If the results of the RP trial are positive, then we plan on presenting at the ARVO meeting held in Florida in early May and potentially to other meetings as well.
We’ve also initiated a retreatment study for RP patients and we will be able to discuss that with you later in 2012. Last on this program, I like to take the opportunity to thank our global investigators and their patience for the work and input in the RP program. We hope to generate positive data from this trial.
Now let’s turn briefly to our Leber Congenital Amaurosis or LCA program, which is a Phase 1B trial for pediatric subjects. We completed the four cohort study of 14 subjects in the second half of last year and we are continuing to focus our efforts on collecting retreatment data in patients with LCA. Some patients are in the process of being retreated and we’re expecting to continue to retreat patients into the second quarter of this year.
As a reminder, I want to mention that we face some logistical challenges and get any LCA patients back at children’s hospital at McGill University in Montreal where all of the retreatments are taking place. The patient follow-up takes place over 30 days and most of the children in trial have to travel to Montreal with one or both of their parents or guardians. So we face some difficulties getting children out of school and parents out to work for that period of time.