CV Therapeutics Inc. Q4 2007 Earnings Call Transcript

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2008-02-27 12:23:07.0

Tags: CV Therapeutics Inc.

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Jim Birchenough.

Louis Lange

Hi, Jim.

Jim Birchenough - Lehman Brothers

Hi, guys. Just a couple of questions, one on your cash burn guidance. You are already on a cash burn run rate for less $85 million and you've got Regadenoson that could get approved, and continued growth of Ranexa. So, I was just wondering why you are suggesting less than $100 million and seeming to get a bit of cushion where you could guide presumably to much lower burn?

Dan Spiegelman

Well, part of it is to give some cushion and the other part deals with the fact that, as I tried to indicate, we would expect cash used in the first quarter to be higher than what we've seen in the last couple of quarters due to annual timing differences.

Jim Birchenough - Lehman Brothers

Any particular reason for the cushion, Dan?

Dan Spiegelman

Just being appropriately conservative.

Jim Birchenough - Lehman Brothers

And then just in terms of thinking about the ex-US opportunity, what sort of economics are you looking for Ranexa ex-US? And how do you think about that, in terms of balancing a global opportunity that might be more attractive once you get a label revision?

Louis Lange

Well, Jim, I think that, once the drug hopefully gets approved, we will want and need a partner. We're in a lot of discussions both territorial and global. And I think it's our goal to maximize the business opportunity, for us and the shareholders. And they all come with different bells and whistles. So I can't be specific about it. But I think the one thing that I would say is the company, the other company has to believe in this drug and we have to believe that they can sell it. So that's very important to us whether that's global or just in Europe.

Jim Birchenough - Lehman Brothers

And just a final question and I will get back in the queue. You have been within two weeks of PDUFA with Renexa, both negatively and positively. You are two weeks in front of PDUFA with Regadenoson. How confident are you that it's going to go positively?

Louis Lange

Well, they are completely different products. Remember a lot of the issues around Ranexa concerned to QT interval. We are dealing with a very straight forward development program where we had 10 studies, the pivotals both work. We invented the molecule. We created every scrap of data associated with it. So I am hoping for the best, but I don't think there is any language that we could say today would be exactly accurate looking forward two and half weeks. So I think that once the FDA, they have been working diligently on this, signs the letter? I think we just have to wait for them.

 

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