Jazz Pharmaceuticals plc (NASDAQ:JAZZ) Q2 2023 Earnings Call Transcript

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Rob Iannone: Yes, happy to, Bruce. So we know that narcolepsy patients have significantly disrupted nighttime sleep. We also know that oxybate have a very big impact in improving the architecture of nighttime sleep. And we think that’s why for a short-acting drug, patients then have substantial improvement in daytime symptoms like cataplexy or excessive daytime sleepiness. When you look across studies of oxybate, whether that be a fixed dose high sodium version or immediate release oxybate there is improvement. It’s very comparable. There’s no evidence that a fixed-dose regimen improves to suite sleep to a greater extent. Patients typically do not normalize their sleep and there’s really no evidence that waking to take a second administration impacts one way or another.

Bruce Cozadd: And then Rob, I think there was a question on reboxetine at the end of the question as well.

Rob Iannone: And sorry, Bruce, could you just repeat that for me then?

Bruce Cozadd: I think the question was any thoughts on data on reboxetine? I mean I’ll just jump in and say historically, we — in our conversations with KOLs, we’ve not found that there’s as much interest in that as other drugs available or in development. This has been available in certain markets for a long time in treatment of other diseases, but we haven’t heard of a huge success in this patient population in the U.S.

Rob Iannone: Okay. Thanks for clarifying that, Bruce. And I would just say that our focus with Xywav is a nighttime administration to address the underlying cause of disruptive nighttime sleep, which has profound effects on daytime symptoms. Reboxetine is one of several drugs that’s used as a daytime alerting agent, and is sometimes complementary to oxybate, but we don’t think a substitute for many patients.

Operator: Thank you. The next question comes from the line of Charles Duncan with Cantor Fitzgerald. Your line is now open.

Charles Duncan: Bruce and team, congrats on good commercial performance in the quarter and thanks taking our questions. Sorry to ask about a nuance in the pipeline, but it actually relates to the next readout that could come. And that’s on JZP150 and PTSD disorder. I guess I’m wondering if given that this is an early Phase II, would you focus more on stat sig and effect size or the overall results of the study to enable the drug to move forward. And then in terms of the statistical analysis plan, it looks like a wide range of doses. So I guess I’m wondering, is it each dose relative to placebo? Or would you combine doses, the analysis of the two dose groups versus placebo?

Bruce Cozadd: Rob, do you want to take the 150 question?

Rob Iannone: Yes. Thanks, Bruce. We do think the cap size is a comprehensive composite endpoint. It has regulatory endorsement as an endpoint that could be used for approval, and it does capture quite a bit the broad range of symptomatology in PTSD patients. So we do think that that’s a good way to measure the effect of the drug. We are measuring other things in exploratory ways as well, which we certainly will take into account. You’re right that the trial is three arms. There’s two active dose levels in placebo. And given the sample size that we have, we feel we’re well powered to make comparisons with both of those different dose levels against placebo. We don’t have to collapse across those ones.

Bruce Cozadd: Well, I think that was our last question. So I just want to jump in and thank all of our questioners for moving us through, I think, most of our commercial business, a lot of our pipeline and our strategy. Hopefully, people feel great about the quarter on the top line, on the bottom line, the new guidance, increased diversification and the momentum we have in our business, particularly our three key growth drivers in Xywav, Epidiolex and Rylaze. I’d just like to close today’s call by recognizing all of our Jazz colleagues for their efforts in delivering new therapeutic options to patients, and thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today.

Operator: This concludes today’s call. Thank you for your participation. You may now disconnect your lines.

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