Xenoport, Inc. (XNPT)

Q2 2012 Results Earnings Call

August 7, 2012 5:00 PM ET


Jackie Cossmon – Investor Relations

Ron Barrett – Chief Executive Officer

Bill Harris – Vice President, Finance and CFO

Vince Angotti – Executive Vice President and COO


Ravi Mehrotra – Credit Suisse

Michael Yee – RBC Capital Markets

Brian Abrahams – Wells Fargo Securities

Eric Schmidt – Cowen and Company

Juan Sanchez – Ladenburg Thalman & Company & Company

David Friedman – Morgan Stanley



Good afternoon. My name is [Temra], and I will be your conference operator today. At this time, I would like to welcome everyone to the XenoPort Second Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. (Operator Instructions)

Thank you. Ms. Cossmon. You may begin your conference.

Jackie Cossmon

Thank you, [Temra]. Good afternoon and thank you for joining us on the call. Here with me today are Ron Barrett, our Chief Executive Officer; Bill Harris, our Vice President of Finance and Chief Financial Officer; and Vince Angotti, our Executive Vice President and Chief Operating Officer.

Before we begin our discussion of today's news, I would like to note that the information to be discussed on this conference call and webcast, including answers to questions asked during this call will include forward-looking statements that involve risks and uncertainties, including statements related to the therapeutic and commercial potential of our product candidates, future sales of and promotional activities for gabapentin enacarbil, FDA and other regulatory authority discussions, regulatory processes and the timing of regulatory filings and actions, our current and future clinical development programs and clinical trials, the release of additional clinical trial data and the timing thereof, our clinical development efforts, potential advantages of our product candidates, our dependence on collaborative partners and matters related to our dispute with GSK.

XenoPort can give no assurance with respect to these statements and we assume no obligation to update them. For detailed information about the risks and uncertainties that could cause actual results to differ materially from those implied by or anticipated in these forward-looking statements, please refer to the Risk Factor section of our most recent SEC filings, including our discussion of the inherent risks of clinical trials and regulatory matters. This webcast is a copyright of XenoPort.

At this time, I will turn the presentation over to Ron.

Ron Barrett

Thank you, Jackie. Good afternoon and thank you to those joining us on today’s call. I would like to discuss our progress since the last quarterly call and then Bill Harris will discuss the highlights of our second quarter financial results. We will both be relatively brief and then we will then take your questions.

We have been busy since the start of the second quarter and I’d like to thanks Xenoport’s employees for their strong efforts in advancing multiple development programs and other business objectives.

Starting with our novel fumarate compound, 829, we initiated the first human trial two weeks ago. We expect dosing of the 60 healthy volunteer subjects in this single dose fed versus fasted Phase 1 trial four formulations of 829 plus placebo will be completed this week. We will have a lot of bioanalytical work to complete and we hope to report preliminary safety, tolerability, pharmacokinetic results from this trial in October.

As you know, we are interested in the potential development of 829 in relapsing-remitting multiple sclerosis or RRMS and psoriasis. In addition to these two potential indications, there are published data that suggest potential utility of Nrf2 activator in a number of neurodegenerative diseases.

In July, we were happy to announce the collaboration with the Michael J. Fox Foundation that will enable us to assess 829’s potential efficacy in the Parkinson's disease animal model.

Now turning to Arbaclofen Placarbil or AP, we expect completion of enrollment of the pivotal Phase 3 trial for the treatment of spasticity in MS patients this fall and topline results in Q1 of 2013. Patients who complete this trial are eligible to continue AP treatment in the six-month open-label safety study.

As I mentioned in our last call, we initiated communication with the FDA to discuss the possible need to modify our trials to ensure that we meet the FDA's safety data requirements of 150 subjects with six months and 100 subjects with nine months of AP exposure.

We now have FDA agreement to enroll subjects directly into the open-label safety study, allowing directly enroll subjects to stay on AP for nine months. We believe that this was a good outcome since it avoided potential modification of the Phase 3 efficacy protocol for which we have a special protocol assessment and should allow us to keep our timeline of the potential filing of the NDA in the second half of 2013.

In June, we also had a productive End-of-Phase 2 meeting with the FDA, regarding our L-Dopa prodrug 279. As I mentioned last quarter, we have discussed the data with of our Phase 2 279 trial with an advisory board comprised of Parkinson's disease experts. They indicated they believe that the pharmacokinetics of 279 compared to Sinemet were impressive, encouraged us to find a way and continue development of product candidate.

We also took note of the results of the Phase 3 trial of the intravenous infusion pump Duodopa, that were presented at AAN earlier this year, where the maximum benefit of Duodopa over optimized Sinemet was observed at 10 to 12 weeks. I’ll remind you that the length of treatment of the optimized doses of 279 and Sinemet in the randomize phase of our Phase 2 trial was only two weeks.

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