Celgene (CELG) Q3 2011 Earnings Call October 27, 2011 9:00 am ET Executives Mark Alles - Robert J. Hugin - Chairman, Chief Executive officer, President, Secretary and Chairman of Executive Committee Jacqualyn A. Fouse - Chief Financial Officer and Senior Vice President Patrick E. Flanigan III - Analysts Jim Birchenough - BMO Capital Markets U.S. Brian Abrahams - Wells Fargo Securities, LLC, Research Division Sapna Srivastava - Goldman Sachs Group Inc., Research Division Michael J. Yee - RBC Capital Markets, LLC, Research Division John S. Sonnier - William Blair & Company L.L.C., Research Division Matthew Roden - UBS Investment Bank, Research Division Robyn Karnauskas - Deutsche Bank AG, Research Division Mark J. Schoenebaum - ISI Group Inc., Research Division Rachel L. McMinn - BofA Merrill Lynch, Research Division Eric Schmidt - Cowen and Company, LLC, Research Division Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division Christopher J. Raymond - Robert W. Baird & Co. Incorporated, Research Division Yaron Werber - Citigroup Inc, Research Division Howard Liang - Leerink Swann LLC, Research Division George Farmer - Canaccord Genuity, Research Division Geoffrey C Meacham - JP Morgan Chase & Co, Research Division Maged S. Shenouda - Stifel, Nicolaus & Co., Inc., Research Division Ryan Martins - Lazard Capital Markets LLC, Research Division Gene Mack - Mizuho Securities USA Inc., Research Division M. Ian Somaiya - Piper Jaffray Companies, Research Division Michael G. King - Rodman & Renshaw, LLC, Research Division Presentation Operator
As a reminder, during today's call we'll be making forward-looking statements regarding our financial outlook, in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent 10-Q on file with the SEC. This statement speaks only as of today's date, and we undertake no duty to update or revise them. Finally, reconciliation of any non-GAAP financial measure to the most comparable gap measure is available as part of the earnings release.I would now like to turn the call over to Celgene's Chairman and CEO, Bob Hugin. Robert J. Hugin Thank you, Patrick, and welcome to your Celgene quarterly conference call. In addition to Patrick, I'm joined this morning by Jackie Fouse, our Chief Financial Officer; and for the first time by Mark Alles, who has been an invaluable member of Celgene leadership team since 2004. Mark leads our commercial organization in the Americas, and earlier this year added a responsibility for our Asia-Pacific operations. He will become our global Chief Commercial Officer in January. Welcome, Mark. Before Jackie and Mark review the financial and operating results of the quarter -- excuse me, I'd like to provide my perspective. It was an outstanding quarter for Celgene. Our teams continue to deliver excellent commercial and financial results were advancing our regulatory, clinical and research programs, all designed to produce sustained long-term growth and valued creation. The strong global performance of multiple products drove our outstanding financial results. These exceptional results support raising our financial outlook for the remainder of the year. Jackie will review this with you in just a few minutes. During the quarter we also made substantial progress on all of our strategic initiatives. We strengthened and expanded the global reach of our hematology and oncology franchises, significantly advanced our development pipeline of 25 Phase III and pivotal clinical trials, and progressed our robust early pipeline of nearly 20 compounds in preclinical and clinical development. All of these initiatives are designed to enhance industry-leading growth well into the future, and are all the more impressive as they were achieved while simultaneously successfully navigating an Article 20 processes in Europe and overcoming strong economic headwinds.
Importantly, during the quarter, we advanced critical programs that has the potential to be significant near-term drivers for our business. As I just mentioned, the REVLIMID Article 20 processes was successfully concluded. This allows us to update our European newly diagnosed marketing application with analysis from the Article 20 process. We're also updating the filing with more mature data from the trials, including the survival data from the CALGB study, which became available during the review period. We're moving forward to complete this work and file the data with the responses to the 120-day questions as rapidly as possible this quarter.We're optimistic that the review process can be completed in the first 3 to 4 months of 2012. It's also our intention to file this updated data in multiple countries including the United States throughout 2012. There are a number of other important regulatory filings that are being finalized for submission. All that have the potential to have a meaningful impact on our commercial results in the coming quarters. We'll follow the submission of our responses to the 120-day questions on the myeloma application with our REVLIMID MDF del 5q application in Europe. Also during this quarter, we expect to support the expansion of our solid tumor franchise with the supplemental new drug application to the FDA for ABRAXANE, for first line treatment of non-small cell lung cancer and in reviewing our filing options in multiple international markets. And before the end of this year, we also plan on enhancing our global expansion initiative with the submission of a new drug application for REVLIMID in relapse refractory multiple myeloma in China. These are some of our near-term drivers. Our Phase III programs reflect our long-term investment in R&D and the areas in which we believe we have a competitive advantage and can deliver innovative breakthrough therapies to patients suffering from serious debilitating diseases. The trials depicted on the slide has the potential to transform the way the patients suffering from these diseases are treated. Our myeloma program is designed to definitively establish REVLIMID as the backbone of therapy in all segments of the disease. With Thalidomide positioned as a potential breakthrough in relapse and refractory disease.
Our MDS trials can extend our MDS and AML franchise to broader patient populations with global potential. We also have encouraging pipeline in Phase II studies in MDS with oral azacitidine and ACE-536. Our lymphoma and CLL programs are advancing rapidly, capitalizing our increasing knowledge of REVLIMID's mechanism of action related to B-cell activity. These are extraordinarily high potential programs which are accruing well.Mark will provide some additional insight on our progress in advancing ABRAXANE, but as you can tell from our Phase III program, we believe in this unique growth potential and are investing accordingly. We're making outstanding progress in our new inflammatory franchise with the accelerating accrual of our Phase III trials for apremilast and psoriatic arthritis and psoriasis. Read the rest of this transcript for free on seekingalpha.com