Jazz Pharmaceuticals PLC at Needham Virtual Healthcare Conference Transcript

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

Question: Ami Fadia - Needham & Company Inc - Analyst : Great. Thanks, Bruce. Maybe just to follow up on the comment related to the tariffs. As you said, they're most likely coming. What would that mean in terms of the cost of goods for the company? Anything you can share today with regards to dependence on countries outside the US for pieces of the supply chain, that could be helpful, and then perhaps any comments around where IP is situated?

Question: Ami Fadia - Needham & Company Inc - Analyst : Yeah, that makes sense. The other thing that's top of mind for investors these days is just, all the changes that have gone on at HHS and the FDA and as you've sort of thought about the submission for Zepzelca and any other interactions with the FDA, have you seen any changes or perhaps if you can just share what experience you've had in terms of just the level of engagement with the FDA and getting feedback and such?

Question: Ami Fadia - Needham & Company Inc - Analyst : Yeah. Okay. Let's switch gears to Chimerix and the asset that you've acquired through that. You have the PDUFA date coming up in second line in August as you just mentioned. How do we -- how does one sort of think about any kind of risks surrounding that PDUFA date? What got you comfortable? And then also, can you talk about the ongoing Phase 3 in first line for which there's data that's going to be reported -- the interim data for that also kind of around the third quarter of the year. So how do we sort of think about approval and then additional data in first line and path to approval in first line, expanding the label in first line? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 09, 2025 / 4:45PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Needham Virtual Healthcare Conference

Question: Ami Fadia - Needham & Company Inc - Analyst : Okay. Maybe if you could also talk about, how this fits into Jazz's core capabilities, in terms of a relatively rare type of an pharmacology indication. And maybe if you could also speak to the market opportunity, both in second line and first line and how you see that evolve over time.

Question: Ami Fadia - Needham & Company Inc - Analyst : Okay. Let's switch gears to zanidatamab. You have the approval and you've launched it in BTC and, obviously, the bigger opportunity is ahead of us, particularly with the GEA ongoing Phase 3 where the data is expected now, later this year. If you could just talk about, firstly, your level of confidence around the study with some of the expected or -- the unexpected longer time it has taken for the events to pan out in the study. So maybe any updated comments there. And what are you looking for in terms of -- what is the bogie for the study compared to the current standard of care?

Question: Ami Fadia - Needham & Company Inc - Analyst : Okay. All right. That was quite thorough. Thank you, Stefan. Perhaps maybe if you could switch gears and just talk about the breast cancer opportunity, which represents perhaps the biggest opportunity for zani down the line in terms of its market size. Where do you see it positioned within the current treatment paradigm and what is the benchmark as we think about second line or third line metastatic breast? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 09, 2025 / 4:45PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Needham Virtual Healthcare Conference

Question: Ami Fadia - Needham & Company Inc - Analyst : Okay. I did want to talk about BTC, which is the indication that you have launched. Maybe if you could talk about how the launch is progressing, what's the initial feedback and uptake, and maybe just looking beyond later in the year, once you do have the GEA data, talk to us about how you're thinking about compendia listing and when that might -- how long that might take following the data, before physicians have the option to start using the drug in GEA?

Question: Ami Fadia - Needham & Company Inc - Analyst : Okay. I want to switch gears and I got the five-minute warning. So I want to switch gears and talk about Zepzelca, and you're getting ready to sort of have the submission in first line maintenance. Can you talk about what you're seeing in the small cell lung cancer market with the approval of Imdelltra, how that's impacting the utilization currently? Obviously, you're commercializing Zepzelca in second line, but then Imdelltra is also being assessed in first-line maintenance in combination with durvalumab. And so in a sort of scenario where that combination also comes forward, how do you think about marketing Zepzelca with the atezo sort of against that product and how do you sort of see that market dynamic play out?

Question: Ami Fadia - Needham & Company Inc - Analyst : So I suppose, yeah, so I guess the same dynamic will go through within -- do you think kind of would be sort of driven by the utilization of atezo in first line? Do you think that --

Question: Ami Fadia - Needham & Company Inc - Analyst : Okay. I'm being told we are out of time, so unfortunately, I would have to close our session here. Thank you so much both of you for taking the time to do this. And thanks for listening as well.

Question: Ami Fadia - Needham & Company Inc - Analyst : Thank you so much.