Bruce Cozadd: Yes. I love the way you ended your question, which is right where I was going to go with my answer, which is we absolutely expect a new product to get some use. But we think all high-sodium patients, be they on Xyrem, AG Xyrem or the LUMRYZ product or potential future Xywav products as we saw from the data we shared earlier this year at the neurology meeting, we can see even in as little as 180 days, an increase in hypertension diagnosis or initiation of anti-hypertensive therapy when starting on a high-sodium oxybate products. So as physicians and patients have already discovered this matters, and we believe that will continue to be important, making Xywav the oxybate of choice.
Operator: Your next question comes from the line of Charles Duncan from Cantor Fitzgerald.
Elaine Kim: This is Elaine Kim on for Charles. Congrats on the quarter. Regarding PTSD, what are your perspectives on the unmet need and the potential for psychedelic medicine such as MAP’s MDMA and possibly compasses [indiscernible] therapy? And where do you see JZP-150 fitting in the emerging treatment landscape?
Bruce Cozadd: Rob, do you want to jump in on that?
Robert Iannone: Sure. So when I think about a treatment like MDMA and what is associated with that in terms of the support that one needs ultimately, I think that that’s going to be appropriate for a subset of the population. PTSD is overall very, very common. And so we think JZP-150 could potentially be much more broadly applicable.
Operator: Your next question comes from the line of Jeff Hung from Morgan Stanley.
Jeff Hung: For the suvecaltamide, what’s the bar for success in the essential tremor study? And can you talk about what gives you confidence that the Phase IIb will read out positively?
Robert Iannone: Yes, I think we have a good sense of — Yes. I think we have a good sense of what’s a meaningful change on the TETRAS endpoints and then more focused on the ADL and a subset of the performance scale as well. And so from our Phase II and from interactions with KOLs and FDA, we have a good sense of what’s going to be a meaningful change there. And you’ve seen the other studies that have been published that could be relative benchmarks. Why do we think that JZP-385 is differentiated? Well, a couple of things. One is that it’s a state-dependent inhibitor. So it selectively acts on active ion channels, which should ultimately create a better therapeutic index. We have a once-daily formulation. And based on our prior studies, we selected a threefold dose range for the Phase IIb, 10, 20 and 30 milligrams, which I think has really allowed us to kind of push that dosing and exposure up to really get maximal efficacy.
So we think it’s differentiated on that basis and hope to see pretty robust efficacy with — across that dose range.
Operator: Your next question comes from the line of Mohit Bansal from Wells Fargo.
Mohit Bansal: So I have a question regarding the oxybate franchise. So can you comment on if there is anything going on with the pricing of Xywav with the — with LUMRYZ and outside generics on the market. I’m asking because this is not the first time since the launch of AG, we have seen a sequential decline in this franchise. So just wanted to understand, how do you see growth to get to the $2 billion number that you’ve talked about in 2025.
Bruce Cozadd: So the quick answer on pricing is there has not been a significant change in terms of sort of our revenue per patient in the past few quarters. In terms of the revenue decline, that’s driven by a loss of Xyrem revenues, which, as I’ve said, have been going down for a long time and are now representing a smaller and smaller portion of our overall revenues while Xywav continues to grow. So those 2 things at present, as was built into our guidance for the year, essentially are offsetting each other to some degree, but our focus is on growing that Xywav business in narcolepsy and importantly, in idiopathic hypersomnia even as we see royalty income off the AG continue to increase.
Operator: Your next question comes from the line of Troy Langford from TD Cowen.
Troy Langford: Congrats on the progress in the quarter. Just with respect to the opportunity with Zanidatamab. I guess what else do you guys think you need to check off that list before you can complete the regulatory submission for the product in H1 ’24 or H1 next year. And related to that, do you all think that you would need to significantly amplify your current oncology sales force to effectively commercialize the product?
Renee Gala: Yes, I’ll jump in on that 1 and just make some comments about our level of excitement about Zani and then ask Rob to comment on the path forward from a regulatory perspective. So as we mentioned on the call, we are extremely excited about this opportunity. This is a highly derisked asset, a global asset for us. And then also one with significant revenue potential. We talked a bit about the data that’s been generated to date since doing this transaction. We continue to be impressed with what we in terms of just robust antitumor activity in HER2. And that’s in both monotherapy and in combination with other agents, and that gives us a ton of confidence to put both significant investment behind the molecule, but then also to outline the opportunity as having peak revenue potential of over $2 billion.
In terms of the near-term need from a commercialization perspective, we don’t believe that this is going to require significant augmenting of our current field force. We believe that, that will be quite efficient. And of course, we are focused on going to market first with BTC, as Rob outlined, and then we’ll build from there. So Rob, you want to comment on development?
Robert Iannone: Yes. I think the specific question was what else is needed to complete the BLA submission for BTC. And it’s just the usual components. As you might expect, some of those components are going to be available sooner than others. And with breakthrough designation, we’ve been given the opportunity to do a rolling submission. That allows us to submit components as soon as they’re ready to give the FDA sort of a head start on reviewing those components. And then as we said, within the first half of the year, expect to be able to provide everything that’s needed to complete that submission.
Operator: And we have no further questions in our queue at this time. I will now turn the call over to Bruce for closing remarks.
Bruce Cozadd: Thank you so much. I’d like to close today’s call by recognizing our Jazz colleagues for their efforts in delivering new therapeutic options to patients and also thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today.
Operator: This concludes today’s conference call. Thank you for your participation, and you may now disconnect your lines.
