The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: So many things you just covered there but maybe we can start on your commercial business here. As you think about the Xywav business that I
think there's been a lot of focus on the sustainability of your sleep wake disorder business. Maybe help provide some context for what gives you
the conviction that Xywav in that growth profile is sustainable in the forward?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: And what are you seeing as the competitive landscape has rapidly changed over the last couple of years, how has that gone, maybe relative to
your prior expectations? And what do you maybe anticipate on the forward?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: And maybe speak to Epidiolex here and you guys have been doing and undergoing additional data generation. How meaningful has that been to
the community and the impact then as it flows through to potential sale?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: And when you think about that expansion into Japan, maybe help provide some context for what that incremental opportunity is. And then as
you think about the data read that's coming in the second half of this year, maybe any areas of risk or should we feel pretty comfortable here given
what you've seen in prior trials.
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Are there, maybe one of the questions I had around this trial is that the inclusion criteria, maybe like the background therapies that patients could
be on are varied between US-based trials versus [one] I guess, how should we think about that?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Great. I want to turn to Zani, since as you mentioned, your most derisked asset. You have a nice -- you have a PDUFA date later at almost the end
of this year. Just remind us the differentiation here, what gives you the conviction as you think about launching in second line BTC, that you will
really be able to gain a foothold there?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: And what will that take maybe from an infrastructure standpoint, as you think about launching into this indication, is your existing sales force
sufficient? Do you need to build it out? How much education, I mean, clearly the data set has been out there, but how much education is required
here?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Maybe on that point, you have always talked about BTC being the starting point to launching you into frontline GEA, into breast cancer, potentially
into other indications. Maybe help remind us what evidence you've seen there, what does give you the conviction as you look to these upcoming
data reads or potential trials that you're running to give you conviction that this really will have a meaningful place there?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Leaning to that point, I mean, these indications that you're mentioning here, they're incredibly crowded. And (inaudible) maybe but the treatment
paradigm itself is shifting so rapidly. How do you think about that in the context of your development plan, then where exactly will Zani fit in as
landscape changes?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: And maybe on one more here as you think about the frontline data that's coming later this year. Help frame expectations around what you could
see, what would be clinically meaningful. Is the clinical bar different than the commercial bar here, the regulatory bar, what would help support a
path to approval.
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Maybe in the interest of time, we can jump over to Suvecaltamide data card (inaudible) imminently here. Help frame your expectations into this
data read, obviously essential tremors has been a very difficult space.
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Got it.
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: And maybe just one point of clarification when you said it was a pivotal study. You do still expect to run a Phase 3 process, like this would not be
sufficient.
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Okay. And if you think about the T-CALM study, which I think as you mentioned, form the basis of a lot of these decisions on how to advance here
-- or sorry, the T-CALM to the study. How do you think about the differences that existed other than the endpoint, right?
There's dosing differences. There's formulation differences, even the patient population slightly different. What do you think is most likely to
positively impact the outcome here?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Maybe let me ask you one more late-stage clinical program question. Zepzelca for frontline, although one where you have a near term data read
coming. Maybe help frame that data set, your expectations into it, what gives you the confidence here that you will be able to see a clinically
meaningful benefit?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Maybe I can continue there. As you think about the evolution of space, obviously, Amgen just had it IMDELLTRA approved. How do you see the
evolution of that space. Clearly, they are also talking about going to earlier line settings. You will presumably be competing against them. How do
you maybe maintain your moat in that landscape.
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Maybe in the last couple of minutes, we've discussed so many different programs. We've not discussed a lot of programs because you have so
many. But you do have these two verticals, whether it's the neuroscience, the oncology. As you think about the forward, how do you think about
balancing one against the other? What maybe what areas are you most interested in and which do you believe really will drive that longer-term
growth?
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: So as you think about corporate development because that does make up $0.5 billion of your Vision 2025 goal that you've put out there. How are
you thinking about deals? Are you looking for maybe later-stage assets they can fill. They can bring on revenue in a more near term fashion. Are
you looking for earlier stage where that return on investment could be greater, maybe more similar to some of the more recent deals you've done?
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JUNE 12, 2024 / 2:40PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Goldman Sachs Global Healthcare Conference
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Maybe in the context then as you think about corporate development here. Remind us where things stand from a balance sheet perspective. You've
talked about being able to delever very quickly post the GW acquisition, but is there an optimal leverage profile you're trying to hit.
Question: Andrea Tan - Goldman Sachs & Co. LLC - Analyst
: Where we do feel comfortable going to with your leverage profile.
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