Medivation, Inc. (MDVN)
Q2 2010 Earnings Call Transcript
August 09, 2010 04:30 am
David Hung - President and CEO, Director
Pat Machado - CBO, CFO
Lynn Seely - CMO
Kim Lee - Global Hunter Securities
Andrew Vaino - Roth Capital Partners
Ram Selvaraju - Noble Financial
Good day everyone and welcome to Medivation, Second Quarter 2010 Financial Results Conference Call. This call is being recorded, at the end of the company’s prepared remarks, we’ll open the call for questions and we’ll provide specific instructions at that point.
I would now like to turn the call over to Joey Fleury.
Thank you and welcome to Medivation’s, second quarter 2010 financial results conference call. On the call today from Medivation, are Dr. David Hung, President and CEO, Patrick Machado, Chief Business and Financial Officer, Dr. Lynn Seely, Chief Medical Officer and Rohan Palekar, Chief Commercial Officer. We issued a press release earlier today, a copy of which can be found at www.medivation.com in the news section.
Before we begin I would like to remind you the various remarks that we make on this call contains forward looking statements, including statements regarding the timing of clinical trail initiation, enrollment and data product candidate potential and continued development, regulatory matters, our collaboration, the sufficiency of our cash resources and statements above our future opportunities and success which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995.
Any statements contained in the call that are not statements of historical fact may be deemed to be forward-looking statements, forward-looking statements involve risks and uncertainties that could cause Medivation’s actual results to differ significantly from those projected, including without limitation press related progress, timing and result of Medivation’s, clinical child, difficulties as a way as in obtaining regulatory approval enrolment of patients in Medivation’s clinical trials, partnering of Medivation’s product candidate, manufacturing of Medivation’s product candidate.
Competition with Medivation’s product candidate should they receive marketing approval. The adequacy of Medivation’s financial resources unanticipated expenditures or liabilities, intellectual property matter and other risks and uncertainties detailed in Medivation’s filings with the Security and Exchange Commission including its quarterly report on Form 10-Q for the quarter ended June 30
2010, filed today with the SEC.
You are cautioned not to place undue reliance on the forward-looking statements which speak only as of the date of this call. Medivation disclaims any obligation or undertaking to update or revise any forward looking statements contained in this conference call.
With that, I will now turn the call over to Dr. David Hung, President and CEO of Medivation.
Thank you all for joining us today. I’ll begin the call with an update on our programs including recent developments. I will then review second quarter financial results and provide updated financial guidance. And I’ll conclude with an outline of our near term company milestone. Just to begin with our Dimebon program. As you know we together with our Partner Pfizer remain committed determining for the Dimebon offers clinical benefit to Alzheimer and Huntington disease patients.
We recently held a Dimebon steering committee meeting with our key investigators and [stock leaders] to discuss the connection data and our ongoing Phase 3 development program. And they too remain supportive and committed to conceiving our trials and securing additional data to determine as Dimebon can offer hope to this underserved patient population.
In order to achieve this goal, we are focusing on CONCERT our 12-month trial in mild-to-moderate Alzheimer’s patients. We are taking Aricept and HORIZON our six month trial in Huntington disease patients. We are encouraged by a continued progress in both trials. In Huntington disease, we are pleased to announce that we had completed enrollment in the HORIZON study of six months randomized, double-blind, placebo-controlled Phase 3 trails designed to evaluate the potential benefits of Dimebon on thinking, memory and global function.
We roll that portal of 403 patients in the HORIZON trial versus our target enrolment of 350 patients. We expect to report top line results from the HORIZON trial in the first half of 2011.
If the data are positive, we will then request a pre-NDA meeting with the FDA. We believe our clinical development program in Huntington disease is an attractive opportunity for Medivation for several reasons. First, Huntington disease is a fatal genetic disease with a substantial unmet medical need. Currently, no medication are approved by the FDA to treat the impairments and cognition in global function that are associated with the condition.
Second, the patient population being studied in HORIZON is more homogeneous at Alzheimer’s patients, because Huntington disease is a genetic disease with a single genetic cause.
And third, we believe that the Huntington disease market represents a commercially attractive opportunity to Medivation even in the scenario where Dimebon is not approved to treat Alzheimer’s disease. The HD indication offers a shorter regulatory approval period, [proper cash] of our premium pricing, reduced commercialization cost and a potentially longer commercial exclusivity period based on orphan drug exclusivity as well as intellectual property.
In Alzheimer’s disease, we presented the data from the Phase 3 CONNECTION study and the separate Phase 3 safety and tolerability study to the FDA as well as at the international conference on Alzheimer’s disease. After reviewing these data, the FDA confirmed that our prior trial published in the Lancet plus our ongoing Phase 3 CONCERT trial will support approval of Dimebon to treat mild-to-moderate Alzheimer’s disease provided that the CONCERT results are robustly positive.