Jazz Pharmaceuticals PLC at Citi Global Healthcare Conference Transcript

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

Question: Traver Davis - Citigroup - Analyst : Yeah. So thanks for the helpful overview. I guess a logical place to start is on Ziihera. As you mentioned, recent FDA approval in BTC, so I don't want to front-run your event next week, but just in terms of an infrastructure build-out, can you just walk us through the launch plans for the drug in this first indication? How many reps will you have detailing it? Will this require sort of a meaningful headcount expansion at Jazz? And I guess then also on education, how much heavy lifting do you think there will be in the field? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 03, 2024 / 3:15PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Citi Global Healthcare Conference

Question: Traver Davis - Citigroup - Analyst : And so you have Phase 3 data coming next year in GEA. But at ESMO a few months ago, you guys provided a data update on the Phase 2 if I recall. So can you just outline the activity for the drug that you saw in that clinical work for this indication? And so I guess, what gives you confidence that the Phase 3 study will be successful and open up a big expansion opportunity for the drug?

Question: Traver Davis - Citigroup - Analyst : And then in GEA, maybe you can just outline the differences in the size of the patient population versus BTC and then also duration of therapy. You mentioned it in the clinical trial experience, but how does that compare to BTC?

Question: Traver Davis - Citigroup - Analyst : So maybe moving down the line of expansion opportunities. You mentioned studying the drug in breast cancer, another significant opportunity. The drug has shown activity with HER2-targeted therapies. So maybe you can just walk us through the approach for bringing this drug through the clinic for this indication. And then how do you expect to eventually position the drug within the treatment paradigm? I guess it's maybe a little bit more crowded than for BTC.

Question: Traver Davis - Citigroup - Analyst : Maybe we could just close the loop on zanidatamab, then I want to go back on the $2 billion-plus total revenue opportunity that you guys have cited. I know that the size of the patient population varies across each of the indications you're going after and I imagine sort of there's level of competition. So maybe you can just frame for us how you build out that $2 billion-plus projection and what assumes are embedded in that?

Question: Traver Davis - Citigroup - Analyst : So is it just in those three indications?

Question: Traver Davis - Citigroup - Analyst : Four, yeah, right. Got you.

Question: Traver Davis - Citigroup - Analyst : Got you. So maybe we can pivot to your pretty substantial commercial business. I certainly want to spend some time there. So maybe you can just provide us with, I guess, a high-level state of the union on your very well-entrenched SLEEP franchise. You mentioned you've launched Xywav. It's already annualizing at $1.5 billion-plus I recall, and IH is driving sort of the next wave of growth there. But there is competition out there as well. So how should investors be thinking about what the SLEEP franchise means to Jazz today, tomorrow, and years down the 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. DECEMBER 03, 2024 / 3:15PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Citi Global Healthcare Conference

Question: Traver Davis - Citigroup - Analyst : Right. And maybe just following up quickly on IH. You mentioned the numbers that you put out in 3Q in terms of where you are when penetrating that market opportunity. So I guess, how should we think about the rate at which you can drive incremental market share in IH? Is it a steady, linear climb, gradual over time, or is it different kind of trajectory?

Question: Traver Davis - Citigroup - Analyst : Maybe we can shift gears to Epidiolex. Over the summer, you shared an update on your Phase 3 study being conducted in Japan. I believe that was for treatment-resistant epilepsies. Probably not the overall outcome that you wanted but you did see numeric improvements in the primary and secondary endpoints and safety seems to remain clean. So I guess, how should we think about what that data means to the overall franchise and also the opportunity within Japan that you've previously called out in the past? But I wonder whether there's clinical outcome impacts that in a way?

Question: Traver Davis - Citigroup - Analyst : I just wanted to dig on the point of generic challengers. So I mean, clearly, you're confident in your IP as you've mentioned. Are there any other challenges that generic entrants face with a pretty unique product like Epidiolex? And do you think that they'll be able to -- and maybe not all of them but some of them not get across the finish line in terms of getting their ANDAs approved because of those challenges?

Question: Traver Davis - Citigroup - Analyst : Got you. And then are you seeing any meaningful impact from recent branded drugs that have come into the space?

Question: Traver Davis - Citigroup - Analyst : Got you. Maybe just moving along to Zepzelca. You recently announced success for your Phase 3 trial in combination use in first-line small cell lung cancer. So maybe you can just walk us through the highlights from that outcome and help in moving Zepzelca into frontline combo use for this population, help sort of expand the overall revenue opportunity.

Question: Traver Davis - Citigroup - Analyst : I think we have time for one last question. I've been following the story for well over a decade now since early days of you guys introducing Xyrem. But you've been very active on the business development front in terms of bringing in new assets to both the commercial and pipeline franchises. So I guess, what are your latest thoughts on M&A from here? What capacity do you think you might have in continuing to build out the pipeline? And how should we be thinking of sort of any particular areas of focus that maybe aren't in today where you could have some interest in?