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QLT, Inc. (QLTI)
Q2 2011 Earnings Call
July 28, 2011, 8:30 a.m. ET
Karen Peterson – Investor Relations Specialist
Robert Butchofsky – President and CEO
Cameron Nelson – Vice President, Finance and Chief Financial Officer
Scott Henry – ROTH Capital Partners
Steve Yoo – Leerink Swann & Company
Jeffrey Cohen – C.K. Cooper & Co.
Cosme Ordonez – GMP Securities
Previous Statements by QLTI
» QLT CEO Discusses Q1 2011 Results - Earnings Call Transcript
» QLT CEO Discusses Q4 2010 Results - Earnings Call Transcript
» QLT CEO Discusses Q3 2010 Results – Earnings Call Transcript
At this time, I would like to turn the conference over to Karen Peterson, Investor Relations Specialist. Please go ahead.
Good morning, everyone. And welcome to QLT’s second quarter 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, uncertainties and undo alliance should not be placed on such statements. Certain material factors or assumptions are implied to 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 underlining such statements, and about the material facts 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 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 GAAP financial measures and information reconciling these non-GAAP finance measures to QLT’s financial results prepared in accordance with GAAP have been included in the earnings press release issued 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 Q2 call today. I want to begin with a brief overview of where we are with the Retinoid Program, and then follow that up by outlining where we are with the punctal plug program. And then I’ll make a couple brief comments about Visudyne sales before turning the call over to Cam to walk you through financial results for the quarter.
As you saw in the press release we issued this morning, we’ve now completed enrollment in the Phase IB study of QLT 091001 for LCA or Leber Congenital Amaurosis, and that’s with a total of 14 subjects enrolled in the trial.
As I’ve mentioned previously, LCA is considered by most experts to be the most devastating retinoid disease with the most severe form of both retinoid degeneration and vision loss, and it affects children soon after birth. And there are, as most of you know, no treatment options currently approved for this disease.
With regards to our 001 program, we’re nearing completion of a protocol amendment that will enable us to begin dosing, doing multi-dosing, of the initial subjects enrolled in this study. The majority of the subjects in the trial have been enrolled for more than 9 to 12 months now and have received only a single seven-day dosing during that period of time.
This retreatment amendment will provide additional treatment cycles if needed with repeat treatments of a seven-day dosing regimen. We expect to have some data and follow up from patients receiving their second treatment cycle of 001 in the coming months.
On the regulatory front, we’ve recently had a very productive meeting with the FDA to discuss the 001 program and outline our thoughts for pivotal trial for LCA.
I’m not going to discuss the meeting in any detail other than to say that we believe it went very well, that the FDA was extremely helpful with our plans to develop this orphan drug and that we anticipate having additional interactions and dialog with the FDA throughout the remainder of this year. And our goal is getting agreement on the more detailed requirements for our regulatory and registration pathway for 001 by the end of this year.
In general though I can tell you we’re proposing a placebo-controlled trial with approximately 30 to 40 subjects. The placebo arm would cross over to active treatment after some period of time.