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: Marc Goodman - Leerink Partners - Analyst
: Rob, can you talk about the orexin, 441? Any type of comment you can make? Have you figured out the safety margin? Is your low dose kind of
doing what you wanted to do? Any comments there would be helpful.
And then just on the settlement with Epidiolex, is there any reason you're being so kg? Can you actually give us the date?
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FEBRUARY 25, 2025 / 9:30PM, JAZZ.OQ - Q4 2024 Jazz Pharmaceuticals PLC Earnings Call
Question: Jessica Fye - JPMorgan - Analyst
: For the HERIZON-GEA trial, I think you said you'll complete enrollment in the next few weeks. So just to confirm, is that for the upsized 918 patient
target enrollment. Can you remind us when you completed enrollment of the originally planned 714 patients? And then I guess while I made on
this trial, Rob, when you see the event rate maturing differently than initially projected as it seems to be here, do you take that as positive, neutral
or negative for probability of success?
Question: Jason Gerberry - BofA Global Research - Analyst
: Mine just on M&A. You guys seem to be flagging that again this year. And I guess it's been a dominant part of the Jazz investor discussion for a
while now, but you really haven't like swung the bat in a big way since GW. And so just kind of curious maybe why that is, ultimately, if you can
reflect on that. And then with this Epidiolex patent settlement in place and not having a runway on a $1 billion franchise plus well into next decade.
Just how does that alter how you guys think about M&A having that longevity of assets now?
Question: Annabel Samimy - Stifel Nicolaus and Company, Incorporated - Analyst
: Just quickly on Zepzelca, just curious if there was any strange trend at the end of the year, we saw it compressing a little bit. And then what can
we expect from Zepzelca this year? I know you're filing the sNDA? The approval is not expected to expect until 2026, but could we be seeing some
entity and guideline -- compendia listing for this specific indication?
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FEBRUARY 25, 2025 / 9:30PM, JAZZ.OQ - Q4 2024 Jazz Pharmaceuticals PLC Earnings Call
Question: Andrea Newkirk - Goldman Sachs - Analyst
: Bruce, I was just wondering if you might be willing to provide an update on the CEO search and the background are fit that the Board is looking
for? And then in the context of this ongoing transition. As a follow-up to the M&A or BD question earlier, how should we think about that strategy
and the timing for a potential transaction to occur this year?
Question: Troy Langford - TD Cowen - Analyst
: Congrats on the results this quarter. Just a really quick one on the opportunity for Ziihera and breast cancer. About how many breast cancer patients
total do you think would fall into that and HER2 progression or intolerance bucket that Ziihera could potentially address? Should (inaudible) succeed
in the Phase III trial?
Question: Amy Li - Jefferies - Analyst
: This is Amy on for Akash. How should we think about the pricing strategy for zani depending on whether the doublet or triplet arm hits in
HERIZON-GEA, if pricing remained consistent, how would the outcome of these arms impact your peak sales estimates?
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FEBRUARY 25, 2025 / 9:30PM, JAZZ.OQ - Q4 2024 Jazz Pharmaceuticals PLC Earnings Call
Question: Mohit Bansal - Wells Fargo Securities, LLC - Analyst
: Congrats on the progress. Rob, if you could help me understand the [RMC] of GEA trial in a little bit detail. It seems like in the context of commercial
aspect, it is a pretty important arm given that majority of the patients that we believe are high patients. But again, this arm is not power to show
benefit over -- so it seems like you are looking at just any benefit over Herceptin. That may be enough.
So in that context, could you help us understand like how would you look at (inaudible) and how should investors like us look at (inaudible) when
the data come out in the context of market opportunity?
Question: David Amsellem - Piper Sandler Companies - Analyst
: So how are you thinking about Zepzelca's exclusivity runway particularly with the label expansion opportunity in first-line? So that's number one.
And then secondly, to the extent that your own orexin program doesn't pan out, I guess my question here is, how badly do you need to be in the
orexin game, so to speak? In other words, would you continue to pursue other orexin? Or do you feel like there's other areas in terms of M&A and
(inaudible) that you would then turn your focus on?
Just trying to get a better sense of how you're thinking about your sleep franchise to the extent there isn't an orexin that moves forward in your
pipeline?q
Question: Ami Fadia - Needham & Company Inc. - Analyst
: Perhaps to switch gears to the oxybate franchise. Can you talk about some of the dynamics in the narcolepsy market and how you're seeing rise
impact either your business or the overall market? Are you seeing switches from Xyrem or Xywav or any switch facts? And then also as the AGs
have the ability to launch their own generics at the end of the year, how should we think about sort of shoring up the Xyrem revenues, switching
them to Xyway or -- and maybe just sort of what type of payer dynamics you expect once additional generics come to market and how that might
impact Xywav?
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FEBRUARY 25, 2025 / 9:30PM, JAZZ.OQ - Q4 2024 Jazz Pharmaceuticals PLC Earnings Call
Question: Gary Nachman - Raymond James - Analyst
: On the 2025 guidance, you didn't break down the revenue components specifically this time. So can you give us more of a sense of how you expect
the neuro and oncology franchises to trend relative to the overall revenue growth of 5% that you said this year? And then just the R&D, as you're
scaling back in expenses relative to last year, down 8%, just talk more about the reprioritization of the pipeline? And what's the right level of spend
going forward for R&D as a percentage of revenue?
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