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

Page 5 of 10

Bruce Cozadd: Thanks, Gary. I’m going to reorder your questions a little bit maybe have Kim take Monday/Wednesday/Friday dosing and then comment on any impact of not having IV. And then, Dan, maybe you can take the ex-U.S. piece of this. So, Kim?

Kim Sablich: Great. Thanks for asking about Rylaze. We’re really pleased that the sales for Rylaze have exceeded the prior U.S. peak sales with Erwinaze and we believe this is a really strong signal that the unmet needs of the market had never truly been satisfied. In terms of Monday/Wednesday/Friday dosing, we really believe when we put this out there that our costumers were utilizing Rylaze and not denying any patients access to it because we had a label with every 48-hour dosing. So, we really were not expecting a lift in sales from the Monday/Wednesday/Friday dosing, but instead probably a lift in customer satisfaction in terms of customers who used to and this is the preferred route of — way of dosing the product would be able to administer it in a way that was closer to what they’re historically used to and prefer.

Dan Swisher: And then, just following up on Kim. This is Dan. So — and very quickly on the CRL question. We don’t see that as a limitation to the uptake in the U.S. market. We’re just looking to get that additional data in the hands of the HCPs ideally through the label, but it’s also been published and presented at ASH. So, the IM uptake has gone very well. Outside the U.S., we filed with the EMA last year, and we do anticipate a approval come in sometime. I can’t remember, you guys can let me know if you’ve given a specific timing. And then, the — on the Japan side, we are going to be engaging with the health authorities and trying to bring this program differentiated from Erwinase to the marketplace. There’s still no non-E.

coli-based Erwinia in the Japanese market. In terms of overall growth, it really depends a little bit on pricing. Europe and the U.S. and Japan likely would be more tied to a lower pricing. And so, historically we saw 80% of Erwinase revenue coming from the U.S. versus Europe, while there is still a lot of patients over there, but ultimately, it depends on how we can differentiate the product. And near-term focus, of course, is getting the product approved. And the EU potential for approval is later this year.

Operator: Thank you. Our next question comes from Balaji Prasad with Barclays. Your line is open.

Balaji Prasad: Thanks for the questions. Just two from me. Firstly, with Vision 2025, including around $2 billion of oxybate, would you discuss the relative role or contribution between narcolepsy and IH towards this vision? Secondly, with Epidiolex, I wanted to address the point where we’re getting significant investor questions, which is the generic challenges to Epidiolex with 10 to 11 filers. Is there any confidence that can provide the market around the durability of Epidiolex? Just want to see that — ensure that this is not an overhang on the stock for the longer run. Thanks.

Bruce Cozadd: Yes. So, maybe I’ll take that second question first, and then we can have maybe Renee jump in a little bit on what we’ve said in terms of the oxybate revenue piece of Vision 2025. On Epidiolex, there’s no new information out there on durability. We’ve said from the time we first announced the GW transaction that we did have a lot of confidence in the durability of this asset. We had predicted correctly the likely timing of first ANDA submissions, and of course, that’s public now with our announcement of the Hatch-Waxman litigation. Since the time of the deal, we did have additional IP issue, including some with longer duration patents. That’s not a surprise. We again predicted that at the time of the transaction. But I don’t have new information to share other than all the things we’ve shared historically that give us confidence that this is not a short-duration product.

Page 5 of 10