Xenoport Q3 2007 Earnings Call Transcript

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2007-11-07 16:58:02.0

Tags: XenoPort Inc.

Question-and-Answer Session

Operator

(Operator Instructions). Your first question comes from the line of Greg Wade with Pacific Growth.

Greg Wade - Pacific Growth

Good afternoon. Thanks for taking my question. First up, for Ron. You indicated there is four Phase 3 for 512. Can you just remind me what the fourth Phase 3 is?

Ron Barrett

Sure.

Greg Wade - Pacific Growth

And then, for Bill Harris. In terms of expenses on a going forward basis for this year and perhaps next year for R&D, would it be more appropriate to take this R&D spend for this quarter, add back to $3.6 million and use that as a run rate? Thanks.

Ron Barrett

Okay, Greg, thanks for the question. And with regard to the description four Phase 3 trials there is no new news here. We have three pivotal efficacy studies 052 which we’ve already reported positive results of. The two studies that I mentioned today are 60 and 053. And then we have a fourth study which is the long-term expansion study, patients who come out of 52 and 53 are offered the ability to roll over to an Open Label Extension Study, that study is called XT-55. So that is an open-label safety study, but it is a Phase 3 study.

Greg Wade - Pacific Growth

Hey, Bill.

Bill Harris

Hi, Greg, it's Bill. Regarding the go-forward run rate on R&D, as you know our policy is to only provide guidance for the cash position. But, having said that, I think it is important to remember that the [3.6] is a non-recurring events, so adding that back is not unreasonable.

Qualitatively you can imagine our expenses are going to track the, primarily the Phase 3 RLS development program, which is kind of crescendo-ing as we speak and expect to wane in the first half of '08, and underneath that you'll have the Phase 2, the two Phase 2s for 986 kind of building up underneath it. So qualitatively, I think you need to think of those two things, but adding back the 36 is reasonable.

Ron Barrett

Operator, can we have the next question?

Operator

Your next question comes from the line of Rachel McMinn with Cowen & Company.

Rachel McMinn - Cowen &Co

Hi, there are a couple of questions. Just to go further on that R&D expense as you mentioned, you guys are going to be completing this big Phase 3 program. So, just philosophically here without asking for specific guidance, should we expect you guys to kind of continue to build up a pipeline, so that those numbers would be similar or should we really be thinking about this as a high water mark?

 

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