Previous Statements by PDLI
» PDL BioPharma, Inc. Q1 2010 Earnings Call Transcript
» PDL BioPharma, Inc. Q4 2009 Earnings Call Transcript
» PDL BioPharma Q3 2009 Earnings Call Transcript
I'll now turn the call over to John McLaughlin, President and CEO of PDL BioPharma.John McLaughlin Also with me today is Cris Larson, our Vice President and Chief Financial Officer, who will discuss our financial results in a few minutes. The second quarter of 2010 has been productive for PDL as we continue to focus on identifying and executing an opportunities to improve returns for our stockholders. During the quarter we achieved an increase in royalty revenue year-over-year, we reduced dilution and strengthened our capital structure by repurchasing a portion of our convertible notes. We realized a gain on our foreign currency hedging contracts and we continue to evaluate new asset purchase opportunities to build shareholder value today and to the future. Beginning with our license products, we were pleased to see the filing of Roche and Genentech biologics license application with the USFDA for Herceptin conjugate for T-DM1. T-DM1 is a novel antibody drug conjugate, which Roche terms and owned the antibody developed for the treatment of patients with advanced HER2-positive metastatic breast cancer. According to Roche T-DM1 has a potential to peak sales of 2 billion to 5 billion Swiss francs and is expected to receive fast-track approval in the United States. As such, we anticipate T-DM1 maybe approved as early as the first half of 2011. In addition to T-DM1 I would like to address some recent news related to Mylotarg and Avastin. As you know it finds with the prepared Company Wyeth voluntarily with through Mylotarg for the market in late June at the recommendation of the FDA. As it relates to PDL Mylotarg represents a small percentage of our overall revenue with royalties 303,000 in the second quarter of 2010. Given this we do not believe this development will have a substantial negative effect on our annual revenue for 2010 and beyond.
Similarly, based on follow-up Avastin breast cancer studies that failed to show our meaningful survival benefit. The FDA's Oncology Drug Advisory Committee recommended that first-line treatment with Avastin in combination with Paclitaxel for HER2-negative breast cancer removed from the US label for this drug. If the FDA accepts the recommendation from the Advisory Committee to remove the approval for first-line treatment of HER2-negative breast cancer we would no longer receive royalties for this indication.Based on our internal model, we estimate in 2009 this indication represented less than 5% of total global Avastin sales. The Advisory Committee recommendation does not impact Avastin use in multiple cancers including advance colorectal, lung, kidney, and glioblastoma. Also last Thursday Genentech and Roche announced that they have filed with the USFDA for the approval Avastin for second-line treatment HER2-negative breast cancer. It is important for me to note that we have provided selected financial information from our internal model for Avastin sales on a stand-alone basis due to the extraordinary circumstance presented by the FDA panel recommendation. We do not intend to make it a standard practice to provide guidance such as this in the future. Turning back to our license products, during the American Society of Clinical Oncology Annual Meeting, it is also known as the ASCO Annual Meeting, in June, Genentech and Roche presented positive data from a Phase 3 clinical trial of Avastin for use in previously untreated advanced ovarian cancer which would be a new and potentially very large indication for the drug. Further recent data from a large multinational Phase 4 trial validates Avastin's use in treating non-small cell lung cancer. In addition to these recent product developments, we saw a number of positive clinical presentations, specifically related to Avastin, Herceptin and T-DM1 at ASCO this year as well as recent positive data presented on late-stage licensed compounds for Alzheimer's disease for which PDL has two Phase 3 products under license, Bapineuzumab and Solanezumab. We anticipate clinical trial results for these two new drugs in mid 2012. Read the rest of this transcript for free on seekingalpha.com