Jazz Pharmaceuticals plc (NASDAQ:JAZZ) Q3 2022 Earnings Call Transcript

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Ash Verma: Hi. Thanks for taking my question. Just one. So on Epidiolex, I think the NCE plus forward timeline passed on September 28. Can you confirm if you have visibility whether there were any Paragraph IV patent certification? Thanks.

Bruce Cozadd: Nothing to add other than we’ve made clear in our filings that that’s the earliest filings could occur. We fully expect there may be filings over time. Of course, those go into the FDA first and come to us later, but nothing to report at this point.

Ash Verma: Okay.

Operator: Please stand by for our next question. Our next question comes from Madhu Kumar with Goldman Sachs. Your line is now open.

Madhu Kumar: Great. Thanks for taking our question. We are curious on how to think about, kind of, Xywav growth in IH and kind of how you look at the trajectory now. Do you think that there’s kind of like a further up ramp to happen? As you mentioned, they kind of — as physicians get more experience with Xywav, they get comfortable with it. There could be like a further tick up and expansion in idiopathic hypersomnia, like, how should we think about that?

Bruce Cozadd: Yes. Kim, do you want to talk a little bit about future opportunity for growth with IH?

Kim Sablich: Sure. So lots of opportunity for growth. We’ve talked in the past about there being already out there in the marketplace, 37,000 patients who are diagnosed with IH and they’re actually out actively seeking health care. So it’s not a sales diagnosis. So we’ve got a nice, healthy patient population to go after. What we’re focused on right now is really ensuring that we’re educating around IH diagnosis. Despite this, given we really want to try to help HCPs ensure that they’re taking into consideration the full range of symptoms that patients are experienced, they’re really used to mostly focusing on that excessive daytime sleepiness the off-label usage of weight-promoting agents and stimulants have been enabling them to address, and we want to make sure that they’re thinking much more broadly about the breadth of symptoms that patients are experiencing and that Xywav can treat.

And then secondarily, we’re helping HCPs to identify patients who maybe be ready for Xywav. And again, a big part of that is around making sure they’re thinking about that full breadth of symptoms. So overall, strong excitement and feedback in the market, but as we’ve said, I think for a long time now, idiopathic hypersomnia is a new market. And we’re excited to build it just like we did with narcolepsy, but we expect that it will take some time and grow gradually. So overall, lots of reasons to be optimistic, but also to appreciate, Jazz is been working in the narcolepsy market for a decade or more now. And we plan to be successful there ultimately with Xywav in idiopathic hypersomnia, but it will take some time.

Bruce Cozadd: I’ll maybe add that, Kim — and Kim mentioned narcolepsy. And remember, our sales force is really trying to do two things here, drive adoption in the new market of IH, but also continue our messaging to the narcolepsy community, including about the importance of the lowered sodium that we see in Xywav that led the FDA to grant the orphan exclusivity based on a safer product because of that reduction in sodium and what that can mean for cardiovascular events. So, important to do that narcolepsy messaging as we continue to grow in IH.

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