Jazz Pharmaceuticals PLC at Bank of America Global Healthcare Conference Transcript

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

Question: Jason Gerberry - BofA Global Research - Analyst : Okay. Maybe we can start with some -- just some strategy-level questions first. And in terms of thinking about the portfolio build-out, if you go back a year or two, people worried about competitive forces that might erode certain monopoly positions in markets like oxybate. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 18, 2024 / 2:55PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Bank of America Global Healthcare Conference We sit here today, you've launched Xywav. I think it's annualizing about $1.5 billion, and IH is a growth source within that. Do you feel like -- I feel like the markets discount the stock because there's still a perceived necessity to do a deal. As you kind of sit here and you talk about disciplined M&A, I'm just kind of curious how you think about the progress to diversify and solidify the base. And then you have some pipeline that you spoke about. Where does M&A ultimately fit in all that? And the fact that you've sort of solidified the base, does that alter, I think, that perceived necessity to do a deal?

Question: Jason Gerberry - BofA Global Research - Analyst : So is it fair to say less of a focus on maybe reducing oxybate as a percent of the revenue pie and more just trying to be opportunistic where you see good assets that could either fit the rare orphan sort of CNS vertical or the oncology vertical?

Question: Jason Gerberry - BofA Global Research - Analyst : Yeah. And one question I get, given now that we've got a number of quarters under our belt, we can see the impact of the AG. We can see the impact of the branded competitor that's out there. Does that, in any way -- I don't know -- lessen the need for an immediate contributor in any way and allow you to focus more on thinking more long term? Just wondering, what are some of the benefits of sort of how you're seeing the durability play out?

Question: Jason Gerberry - BofA Global Research - Analyst : Yeah. So [RenTe] how the best way to ask this question. So a lot of investors have wondered about the -- having oncology and CNS under one roof. Other companies have made the decision strategically to kind of break those apart. If zani data are as strong as you hoped you would -- and you're not getting credit in the stock, right? How are you guys thinking about sort of the idea of keeping these two businesses under one roof and especially, if the markets aren't coming around to that? Because a lot of people will say to me, I think there's a lot of trapped value with the oncology business right now in Jazz proper. And so I think zani data will put that truly to the test next year when you do put the Phase 3 data card. So just curious if that's a thought process at all with the management, the Board, in terms of keeping these two businesses together. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 18, 2024 / 2:55PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Bank of America Global Healthcare Conference

Question: Jason Gerberry - BofA Global Research - Analyst : Understood.

Question: Jason Gerberry - BofA Global Research - Analyst : Yeah.

Question: Jason Gerberry - BofA Global Research - Analyst : Yeah. Let's talk about zani and the update at ESMO. In terms of kind of key takeaways, it seems to us that maybe the PFS improved a little bit. So maybe the margin for error on the primary registrational endpoint has a little bit more cushion. I guess, the other thing we've observed in some competitor studies is that the ToGA regimen seems to maybe be doing a little bit better than the original study. So maybe how do you kind of distill down the learnings of ESMO as it pertains to that frontline GEA study and your confidence that will hit the registration endpoint?

Question: Jason Gerberry - BofA Global Research - Analyst : Along those lines, you've guided to zani being about a $2 billion between the three indications, I think, BTC, GEA, and breast. I would assume GEA is a pretty meaningful proportion of that number. Just to confirm, I think there's about 5,000 to 10,000 US patients that have that HER2 amplified on breast cancer profile.

Question: Jason Gerberry - BofA Global Research - Analyst : Yeah. And as I think about data scenarios for GEA, the one thing I struggle with is if you, with your doublet arm, show really good data, even strong relative to KEYNOTE-811 in terms of PFS profile, why the market wouldn't just consolidate to doublet? What's the rationale for going to a triplet in that scenario? And so I guess, the question really is, how much incremental benefit do you feel like the triplet arm needs to show in, perhaps, a subset of patients to be the approach for some versus consolidating the market back to doublet therapy?

Question: Jason Gerberry - BofA Global Research - Analyst : Yeah. Maybe just --

Question: Jason Gerberry - BofA Global Research - Analyst : Sure. Okay. And then another ESMO question, just like -- ENHERTU as a competitive threat does come up a lot. They had some data at ESMO. Not sure if you saw that data and had any thoughts. There were several treatment arms. It seems like they maybe have some combinability issues. One arm had like 50% dropout rates; another arm had really profound PFS. So just how do you kind of contextualize the ENHERTU competitive threat?

Question: Jason Gerberry - BofA Global Research - Analyst : Okay. So in the last five minutes, just a couple of quick hitters on the commercial business. So maybe starting with oxybate, about 3,000-ish patients; you're adding a couple of hundred a quarter. So that's like something like 10% penetrated into a TAM you guys have defined for IH. Is this -- do you draw parallels to the narcolepsy launch, where it's just the sort of kind of slow, smoldering, continued progression? I think about competitor drugs like WAKIX. Like, they just seem to consistently add a couple of hundred patients a quarter. I'm wondering how to think about IH because it is the primary sideway growth driver going forward. And so I'm wondering if my characterization of that is accurate, and your confidence level to keep kind of just building that patient base at the pace that we're at?

Question: Jason Gerberry - BofA Global Research - Analyst : Yeah.

Question: Jason Gerberry - BofA Global Research - Analyst : And then on the orexin program, it sounds like there's a potential to revive this program and identify appropriate therapeutic window without the QT interval prolongation. Has that been internally understood and characterized? Should we expect an update on the 3Q call as it pertains to that program? Just anything you can say on that front.

Question: Jason Gerberry - BofA Global Research - Analyst : Final question from me. As it pertains to Epidiolex in the ongoing patent litigation, there were a number of filers. But I just wonder if they're paper ANDAs, right? Like, do you know if anyone's actually committed the investment to be able to manufacture botanical-sourced material, which is kind of what the FDA has guided to? I imagine during the litigation process, you get some line of sight into what the ANDA challengers actually have. But just curious if you can comment at all on that.

Question: Jason Gerberry - BofA Global Research - Analyst : Sure. Okay. I think we're at time right? Well, thank you guys so much for joining us.