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

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We’ve been out there doing that for a year, but HCPs are continuing to have a very impressed reaction to these data that has shown that we can reduce seizures by around 60% in LGS and Dravet and nearly 50% in TSC. So, overall, we’re very excited about the future potential of Epidiolex as a significant contributor to our top-line and to Vision 2025.

Operator: Thank you. Our next question comes from Marc Goodman with SVB Leerink. Your line is open.

Marc Goodman: Yes. Can you give us a flavor for the persistence of these patients, the IH patients, and how that’s going? We know what the number is at the end of the quarter. I’m just kind of curious if there are a lot of patients that are already dropping off and you’re getting a lot of new patients, so that’s the net effect. So, just trying to get a sense of that. Maybe on an absolute basis, you can give us a sense, or even on a relative basis, relative to how the drug is used for narcolepsy and the persistence there? Just maybe give us a sense there. And then, just one quick question, just on the R&D guidance. Is there included any major milestones in there or is that just increased because of the clinical studies that you’ve already mentioned?

Bruce Cozadd: So, maybe Kim will come to you on what we’re seeing in terms of patient staying on IH thus far in launch, although we’re still pretty early. And then, Rene, maybe you can take the question on R&D guidance. Kim?

Kim Sablich: Got it. Had to come back off of mute. Yes, so we’re 14 months into the launch, and we continue to be really pleased with the uptake and we’re still seeing from the marketplace a lot of excitement about having the first, only-approved product for IH. We have had compelling growth continue into this quarter with 1,750 active patients exiting the quarter and we’re expecting to have — continue to have a strong growth here. In terms of persistence, I basically just say it’s pretty consistent in terms of what we see in narcolepsy. So, the number we do report around active patients is that net number that includes both those coming on and as well as those coming off. Our focus in IH remains on educating prescribers on how to better diagnosed IH and identify patients who would benefit from Xywav.

We’re reminding them that IH is a 24-hour condition and that Xywav is approved to treat the full condition, and can address multiple symptoms of IH, not just the daytime symptom of excessive daytime sleepiness. And keep in mind, I think we caution for some while that we’re building the market here. This is the first and only FDA-approved treatment for IH in adults. Overall, in the long-term, we feel as we build this market, we’re really confident in our ability to ultimately maximize Xywav’s potential in this very underserved marketplace.

Renee Gala: Yes. And then I’ll just chime in Marc with respect to the R&D milestones. So, our increased R&D guidance is really a reflection of an expanded more robust pipeline. Clearly, you saw the expenses in Q4 come up a reflection of taking on the zanidatamab program, which we want to invest fully behind across 2023. So, it’s a combination of zani and the clinical programs to support that, the later-stage studies for suvecaltamide, of course, JZP150, we expect to read out at the end of this year, and then the broader expansion altogether. I had mentioned on the call that we have a pipeline today that’s four times the size of the one that we had not that long ago in 2015. So, the focus we’ve had on disciplined capital allocation has enabled us to be able to lean more into R&D as part of our spending in 2023.

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