Medivation, Inc. Q1 2010 Earnings Call Transcript

Medivation, Inc. Q1 2010 Earnings Call Transcript
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Medivation, Inc. (MDVN)

Q1 2010 Earnings Call

May 10, 2010 04:30 am ET

Executives

Nicole Foderaro - IR

David Hung - President, CEO and Director

Lynn Seely - CMO

Analysts

Michael Yee - RBC Capital Markets

Ram Selvaraju - Hapoalim

Andrew Vaino - Roth Capital

Howard Liang - Leerink Swann

Presentation

Operator

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Good day everyone and welcome to the Medivation first quarter 2010 financial result 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 on how to ask questions.

I would now like to turn the call over to Nicole Foderaro. Please go ahead, ma'am.

Nicole Foderaro

Thank you and welcome to Medivation's first 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 that various remarks that we make on this call contain forward-looking statements, including statements regarding the timing of clinical trial initiation, enrollment and completions, the receipt of related payments and projected operating expenses and cash levels that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts maybe 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, risk related to progress, timing and results of Medivation's clinical trials, difficulties or delays in obtaining regulatory approval, enrollment at patients in Medivation's clinical trials, partnering in Medivation's product candidates, 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, reliabilities and intellectual property matters and other risk and uncertainties detailed in Medivation's filings of the Securities and Exchange Commission including as quarterly report on Form 10-Q for the quarter ended March 31st, 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's disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this conference call. With that I will turn the call over to Dr. David Hung, President and CEO of Medivation.

David Hung

Thank you all for joining us today, I will begin the call with recent developments, Pat will then review first quarter financial results and provide financial guidance. And I will conclude with an outline of company milestones that we anticipate achieving this year. As you know in March, we and our partner Pfizer announced disappointing results from the Phase 3 CONNECTION trial of Dimebon in mild-to-moderate Alzheimer's patients. Dimebon failed to meet any of the efficacy endpoints in this trial.

In the weeks following the data announcement, we and Pfizer have conducted a thorough analysis of the CONNECTION data and study logistics to better understand the result. The conclusions of our analysis are that Dimebon did not demonstrate clinical benefit in the CONNECTION study and that no systematic issues with the study logistics were identified that would explain the results. After considering the CONNECTION results and all other available Dimebon data had generated to-date, Medivation remains committed to determining that the Dimebon office clinical benefit to Alzheimer's and Huntington's Disease patients.

In reaching this conclusion we considered multiple factors including the following: number one, the clinical benefit in mild-to-moderate Alzheimer's disease and Huntington disease seen in two prior dimebon trials. Number two, dimebon's excellent safety and tolerability profile across all studies completed to-date totaling more than 2,000 patients. Number three, our strong preclinical package consistently demonstrating dimebon's pharmacological activity across multiple assays. And number four, the significant unmet need for improved treatments in both AD and HD.

While the above factors convinced us that dimebon development should continue. At the same time, we realize that the probability of success for dimebon, particularly in AD had to reduce by the disappointing CONNECTION results. Thus we cannot justify proceeding with the comprehensive development program we had in place prior to the CONNECTION read out.

Accordingly, we have decided to streamline our ongoing dimebon development program to focus fully on the trials that we believe have the highest probability of demonstrating a benefit to patients that also happen to be the furthest along in development. We will discontinue the trials that do not meet these criteria. The Phase 3 dimebon trials that we will be continuing are CONCERT, our 12 month trial in mild-to-moderate AD patients were taken to donepezil and HORIZON, our six months trial in HD patients.

Medivation holds operational responsibility for both these trials and we intend to move forward with them. Our goal is complete patient enrollment in both CONCERT and HORIZON this year. Our decision to prioritize these two trials was influenced in large part by the following considerations.

First, with the 12 months dosing period CONCERT provides twice as much time as CONNECTION to observe potential benefit in dimebon treated patients and potential decline in placebo patients. Second, the patient population being studied in HORIZON, HD patients, is more homogenous than Alzheimer's patients because Huntington's Disease is a genetic disorder caused by a single gene mutation. Third, we believe that the estimated incremental cost of Medivation of continuing CONCERT, HORIZON through completion as compared to the cost of shutting down these trials produces a favorable risk adjusted return to Medivation given the large commercial opportunities we are targeting.

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