Incyte CEO Discusses Q3 2010 Results - Earnings Call Transcript
Incyte (
)
Q3 2010
Earnings Call
November 9, 2010 8:30 a.m. ET
Executives
Paul Friedman – President and Chief Executive Officer
Patricia Andrews – Executive Vice President, Chief Commercial Officer
David Hastings – Executive Vice President, Chief Financial Officer
Richard Levy – Executive Vice President, Chief Drug Development and Medical Officer
Pamela Murphy – Vice President, Investor Relations/Corporate Communications
Analysts
Bret Holley - Oppenheimer
David Friedman - Morgan Stanley Smith Barney
Eric Schmidt – Cowen & Company
Rachel McMinn – Bank of America Merrill Lynch
Tommy - Jefferies & Co
Avik Roy - Monness, Crespi, Hardt
Joshua Schimmer – Leerink Swann
Liisa Bayko – JMP Securities
Tom Russo – Robert W. Baird
Mark Monane - Needham & Company
Presentation
Operator
Compare to:
Previous Statements by INCY
»
Incyte Corporation Q2 2010 Earnings Call Transcript
»
Incyte Corporation Q4 2009 Earnings Call Transcript
»
Incyte Corporation Q3 2009 Earnings Call Transcript
»
Incyte Corporation Q2 2009 Earnings Call Transcript
Greetings, ladies and gentlemen, and welcome to the Incyte Corporation’s Q3 2010 financial results. [Operator Instructions.] As a reminder this conference is being recorded. It is now my pleasure to introduce your host, Ms. Pamela Murphy, vice president of investor relations and communications. Thank you, Ms. Murphy. You may begin.
Pamela Murphy
Thank you and good morning. On the call today are Paul Friedman, Incyte’s President and Chief Executive Officer; Dave Hastings, Executive Vice President, Chief Financial Officer; Rich Levy, Executive Vice President, Chief Drug Development Officer and Medical Officer; and Pat Andrews, Executive Vice President, Chief Commercial Officer.
To begin, Paul will review recent developments at Incyte and Dave will follow with a discussion of our Q3 financial results. We’ll then open up the call for Q&A.
Before beginning, we’d like to remind you that some of the statements made during the call today, including statements regarding our plans and expectations for our drug development programs, including the timing of our clinical trials, regulatory submissions, and the potential safety and efficacy of our compounds, as well as our expected financial results and guidance are forward looking statements. These forward looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described from time to time in our 10Q for the quarter ended June 30, 2010, and from time to time in our SEC documents.
Paul?
Paul Friedman
Good morning everyone. We continue to make excellent progress on all fronts, as reflected in the increase in publications and presentations of our clinical results, most notably for our JAK1 and JAK2 inhibitors.
In particular, data from our lead JAK inhibitor, Incyte 18424, was the subject of an article in the New England Journal of Medicine, in which the potential of 424 in the treatment of myelofibrosis was described. As there are currently no approved therapies for this disease, we are encouraged by the conclusions of the authors, as well as the comments in the accompanying editorial by [inaudible], which reaffirms JAK1 and JAK2 inhibition as a new targeted therapy for myelofibrosis.
Now also tomorrow the full 24-week Phase 2A results of Incyte 28050 in rheumatoid arthritis will be presented at the American College of Rheumatology annual meeting. We are hosting a presentation of the data Wednesday evening, tomorrow evening, that will be one chance for those of you who are not attending the ACR meeting in person.
Beyond these accomplishments, we're especially looking to the completion of the two Phase 3 trials with 18424 in myelofibrosis. The controlled portion of the U.S. trial COMFORT-1 has completed, and we expect to release the top line results in the second half of December. Provided the results are positive, we intend to submit a new drug application in the first half of 2011. The European registration trial COMFORT-II, being conducted by Novartis, is also expected to be completed this year, and the MAA submission is planned in the first half of 2011 as well.
Full results from both studies are expected to be submitted for presentation this coming June at both the ASCO and the European Society of Hematology meetings. As part of our objective to expand the use of 18424 into a second indication in myeloproliferative neoplasms, we secured a special protocol assessment, which we've talked about before, for a Phase 3 trial in patients with polycythemia vera, and we began this joint local Phase 3 trial, called RESPONSE, in the U.S. last month, and last week we announced the achievement of $50 million in milestones as a result of the start of that trial.
We look forward to the initiation of RESPONSE outside of the United States, which Novartis has targeted to commence in early 2011. If trials progress as planned, we could present data in the first half of 2013 and submit the SNDA in the second half of 2013. Additionally, with respect to 424, the COGs group, the Children's Oncology Group, is conducting now a pediatric Phase 1-2 trial of the compound in patients with relaxed or refractory solid tumors, leukemia, or myeloproliferative neoplasms. Enrollment continues and it is expected to complete in the second half of 2012.
Moving to our second JAK inhibitor, Incyte 28050, which is now known as LY3009104, this compound is in Phase 2 development for the treatment of RA. I had mentioned earlier that data from the Phase 2A trial will be presented tomorrow. This is a compound that's part of a licensing and collaboration agreement with Eli Lilly.
This quarter we elected to exercise our co-development rights for the compound. As a result of this decision, we'll now be responsible for funding 30% of the associated global development costs through regulatory approval in our RA. In exchange for co-funding the development costs, our royalty rate will increase across all tiers, resulting in effective rates ranging up to the high 20s, with potential future global sales of LY in RA. We believe that this decision has significant future financial upside for the company.
Read the rest of this transcript for free on seekingalpha.com
