Jazz Pharmaceuticals plc (NASDAQ:JAZZ) Q4 2022 Earnings Call Transcript

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Ash Verma: Hi. Thanks for taking question — my question. I have two. So, first one on the suvecaltamide. So, what’s the level of confidence here in the essential tremor mechanism, the T-type calcium channel pathway? And we’ve seen that Neurocrine failed with the same mechanism and Praxis data is expected shortly. Is your molecule in any way different versus some of these competitors? And then, second, I wanted to see if you can provide any kind of a color on what you’re observing in the marketplace for the Xyrem AG. Are stable patients getting switched to AG whenever they’re going back to the physicians for their regular checkup? Or are the insurance clients driving the AG uptake without patients seeing the doctor? I’m trying to just get a sense of how quickly Hikma can take a share here.

Bruce Cozadd: So, let’s go first to Rob on the 385 question, on the suvecaltamide question.

Rob Iannone: Yes. I would start just by saying that we had the benefit of a Phase 2a proof-of-concept study before initiating our current trial, which enabled us to see the fact there was the response that we expect to see based on the mechanism and consistent with our preclinical data. It also allowed us to identify what would ultimately be the right patient selection criteria and the right endpoints, of course, in agreement with the FDA for that trial. And so, we think the prior data that we had in our Phase 2 with our molecule gives us confidence about the outcome of the ongoing Phase 2b, which, as you know, is three doses with a once-daily formulation.

Bruce Cozadd: Yes. And I’ll just add on the second part of your question. Probably too early for us to comment on payer dynamics. We saw obviously where Hikma put their WAC pricing at the time of launch. We’re aware that there is some uptake of the AG as we would expect and as was built into our expectations coming into the year, and this is built into the guidance we’ve given you, but I don’t think we’ve got enough data yet to get more specific.

Operator: Thank you. Our next question comes from Ami Fadia with Needham & Company. Your line is open.

Ami Fadia: Great. Thanks for taking my question. Maybe firstly, just on the IH market, since you’ve been in the market for some time now, any sort of updated thoughts around the size of the market and the value of Xywav, are you seeing more patients being diagnosed and treated in the market? And then, just a follow-up on JZP385. Can you remind us how you’re thinking about the essential tremor patient population as opposed to the Parkinson’s disease? Are there similarities or differences that we should be thinking about as we consider — if we see positive data in essential tremor, do we — does that give us greater confidence that in the Parkinson’s disease drug would also work? Thank you.

Bruce Cozadd: So, Kim, maybe you could start on just how you’re thinking about the IH opportunity overall.

Kim Sablich: Yes, sure. I’ll start by reiterating that we feel like we have compelling growth in IH, already was 1,750 patients coming out of the end of the year and do expect it to grow nicely moving forward. But as we said, we are building a market here. There’s quite a bit of education to do. So, we’re still trying to estimate ultimately how big this will be. We feel very optimistic, but we know we need to still educate prescribers on how to better diagnose IH. There are 37,000 patients out there we’ve been talking about that are diagnosed and actively seeking treatment. But the HCPs have kind of shown us that they tend to think fairly narrowly about the condition. It’s being all that excessive daytime sleepiness. And we’re reminding them that this is a 24-hour condition and that we’re approved with Xywav to treat the full condition and address multiple symptoms of IH, not just EDS.

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