Jazz Pharmaceuticals PLC Xywav Investor Update Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : I feel like there have been a number of questions kind of related to this, but just to ask it directly, can you comment on how you envision the shape of the launch ramp for Xywav in IH?

Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst : Maybe just on the dosing regimen, just given that you have the once-nightly and twice-nightly in the label for IH, any color on the number of patients who completed the trial on the once-nightly dosing? I think in the label, you say that 23% started the double-blind withdrawal period. And then along those same lines for Dr. Bogan, in practice, how are physicians going to weigh up whether to start a patient on the once-nightly or twice-nightly dosing regimen for IH? Richard Bogan Yes, I'll jump in. The Europeans have -- seem to have more longer sleeper types. And part of that is just the clinical people they see. And some of these folks have such severe sleep inertia, they can't awaken in the middle of the night to take a second dose. So many of the patients were started -- they can only -- they were prescribed 2 doses, but they started out with 1. But after they began to get a response, they could wake up and take the second dose. And based on our experience in narcolepsy patients, in the pharmacokinetics and the pharmacodynamics of the drug, most of us in the U.S. prefer twice dosing. So in the clinical trial, I can't remember the exact percent, but it was around -- it was over 80% ended up in the stable dose period on twice-nightly dosing. But for those who couldn't, we gave them 1 dose, and we could go up to 6 grams, which is not the dose that we typically use, but we could go up to 6 grams in 1 dose. And those patients also showed benefit with taking 1 dose. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 13, 2021 / 8:30PM, JAZZ.OQ - Jazz Pharmaceuticals PLC Xywav Investor Update I mean the parameters, the Epworth, the Idiopathic Hypersomnia Severity Scale, the Patient Global Impression, all of those parameters were statistically significant. I mean they showed response. So we have the flexibility to be able to use 1 dose and 2 doses. But I would say, in my experience, over 80% of the patients are going to be on twice-nightly dosing.

Question: Gary Jay Nachman - BMO Capital Markets Equity Research - Analyst : Okay. Great. Just following up with Dr. Bogan on a previous comment. If most patients have IH chronically, any concern with them taking Xywav indefinitely well beyond the 6 months that you saw in the open-label extension of the Phase III? Would you consider taking them off at any point to see if they go into remission? I know there's been good durability with the narcolepsy patients on oxybate. Bruce mentioned earlier, a lot of them stay on for their entire lives. I'm just curious if you think that should be the same with IH, that same kind of durability? Richard Bogan Yes, that's an interesting question because we don't really know. It's rare, in my experience, for it to remit. But as we understand more about the disorder that maybe the standard of care is, hey, we have someone who's doing really well, and maybe we'll start withdrawing drugs. Because the first thing that will happen is they'll quit taking stimulants in the daytime because most of the patients on Xywav are still going to be on some sort of wakeness-promoting medication. So they might give a signal. And some of them don't. Some of them just take the Xywav. But as we follow the patients over a period of time, that may -- that's an interesting question whether we will do a clinical challenge. My impression is probably not. This is considered chronic in most people. And I see this a lot in some of my narcolepsy patients. They may miss a dose here or there or whatever. And then they're like, "Well, gosh, I didn't get that bad. Maybe I don't need it." And they stop the drug, and then 2 months later, they're like, "Uh-oh, now I see where I was." So it's not unreasonable to maybe test people, periodically withdraw and see how they do. But the majority -- well over 80%, maybe 90% are going to be on the drug forever really. And I have patients that have been on Xyrem since the clinical trials, 2002 and -- for narcolepsy, obviously. But yes, these are chronic long-term therapy medications.