The following is excerpted from the question-and-answer section of the transcript.
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Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. Very helpful. And I was at ASCO and I was very impressed with BTC data. Definitely, want to talk about ZW25. Let's start on sodium
oxybate. And I think the question I get a lot from investors is you put out Vision 2025. And I will -- to your team's credit, you usually do not miss
guidance. I can actually -- you give a wide range. I've traditionally said you hit guidance again and again.
There is a perception right now. Epidiolex is launching well. It is a good product. The business will, quote-unquote, break. That Jazz will walk away
from Vision 2025, and you've talked about roughly $2 billion in sales between the royalties, Xyrem and Xywav in 2025. Talk to me about where you
stand right now and your confidence that the business won't, quote-unquote, break on the sodium oxybate side over the next two years?
Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. Now, maybe to your point, I think one thing that isn't necessarily well understood by investors is there are kind of three buckets. You
have naive. You have sodium oxybate refractory patients. These are patients that maybe you've tried adjust product in the past. And you have
actual switches.
If you look at Avadel is [compassing] Q1, what they said was actually, we didn't take a lot of patients from Jazz [resonant]. In fact, they said it was
50/50 naive, and then patients who were refractory to a sodium oxybate treatment. There is this dynamic where everything's binary, right. A patient
for Avadel is not a patient for Jazz. And I think that's how we simply think about these things.
What about the paradigm that both products would be able to grow? Let's say, Xywav and Avadel's product, LUMRYZ, over the next two years.
And have you seen patients currently switching off of a Jazz sodium oxybate regimen onto Avadel or actually have you seen the reverse?
Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. That's very helpful. Now maybe going and stepping back, another part of Vision 2025 is the M&A component, about $500 million. I'm
guessing that refractory BTC for ZW25 is probably $50 million. So we are still talking about $450 million.
Phil, who, by the way, is beloved from Lilly Investors. I consistently hear that. I think he gave an interesting comment on the Q1 call, where he's like
you like what we're not going to do our value destructive deals simply to hit Vision 2025. And by the way, when we think about the rate like the
revenues and how quickly you have to buy it and then the multiple.
I don't think people would be happy if you bought this year or something like that. I'm just going to say. So what does he mean by that? Can you
expand on what's still meant by that comment? And how committed are you to the framework of Vision 2025 of about $450 million in revenues
that would have to come probably by next year? Is there appetite for maybe more biological risk for a BD deal where it's not actually revenues that
are on the market today. How do you think about the risk benefit of one of those approaches?
Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. I mean this is kind of a question that I think people have for Neurocrine as well. They have a very important readout with a muscarinic
in Q3, and people say, hey, Kevin, are you going to do a BD deal ahead of that or after?
And I think a lot of investors want -- even in your case, you have a similarly big card flip, which is ZW25, HERIZON-GEA at the end of the year is a
pivotal dataset. Why do a deal, especially if maybe it would require equity value, until you've had that card flip, considering it's such a big value
driver from how your company internally feels about that asset. So again, appetite for BD before the HERIZON-GEA card flip and after, do you feel
like there's a difference?
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JUNE 06, 2024 / 6:00PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Jefferies Healthcare Conference
Question: Akash Tewari - Jefferies LLC - Analyst
: Is that your [potent] HER2 program?
Robert Iannone - Jazz Pharmaceuticals Inc - Executive Vice President, Global Head of Research And Development, Member of the Executive
Committee
Yes.
Question: Akash Tewari - Jefferies LLC - Analyst
: I was at ASCO as well. I think one of the things maybe investors aren't appreciating right now, if I look at BTC and GEA, they're both instances where
there's heterogeneous HER2 expression. I think the pushback a lot of investors have is if we look at Herceptin PERJETA in a similar setting to what
you're running in first line, that failed. You did not see a benefit on Herceptin PERJETA with chemo versus tras chemo. Why would that show up
with a bispecific antibody that's hitting kind of same epitopes?
Can you talk to me about what Herceptin PERJETA showed in BTC compared to your data?
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JUNE 06, 2024 / 6:00PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Jefferies Healthcare Conference
Robert Iannone - Jazz Pharmaceuticals Inc - Executive Vice President, Global Head of Research And Development, Member of the Executive
Committee
Sure.
Question: Akash Tewari - Jefferies LLC - Analyst
: I think the question comes for HERIZON-GEA, what's the bar? And I've noticed your team is not -- a lot of these companies -- I think if you look at
your powering, especially, when you've increased powering for next year, you can kind of do that math on PFS. I think you'd be able to hit with the
effect size as small as two months. It doesn't seem like that's the bar that your team is looking for this study.
It seems like on PFS, the bar internally for you guys is maybe four months plus. Talk to me about what investors should be looking at for what's
clinically meaningful for PFS for HERIZON-GEA.
Robert Iannone - Jazz Pharmaceuticals Inc - Executive Vice President, Global Head of Research And Development, Member of the Executive
Committee
Yes. So the bar versus our expectation might be different, right? So if you just look at other references around PFS, so what was it for KEYNOTE-811
less than two months?
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JUNE 06, 2024 / 6:00PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Jefferies Healthcare Conference
Question: Akash Tewari - Jefferies LLC - Analyst
:
Question: Akash Tewari - Jefferies LLC - Analyst
:
Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. Okay. Blow away is the quote from today's fireside. Okay, I'm going to ask the strategic question, and this is -- I wish Bruce was here
for this, but I'll try for you guys either. So in late '23, there was a Bloomberg article. Did not come from Jazz, let's be very clear, saying, hey, there
are options for Jazz as both strategically as a takeout, or B, breaking up the company.
I think this stock has chronically been viewed as, in terms of free cash flow, far more valuable than what investors are ascribing because you'll have
these competitive overhangs and it's just difficult to maybe model some aspects of the business from '25 to 2030.
I cover Exelixis, right? Exelixis is a catalyst, a $2 billion drug. It's got an IP overhang. It's going to trade somewhere between $6 billion to $8 billion.
You guys are trading at close to a 10-year low. You may be technically trading at five times next year's earnings.
If -- let's just play HERIZON-GEA, you get approved in PD-1 high, PD-1 low. And our math, that suggests that could be a $1.5 billion indication in
first line in of itself. You have IP presenting out to 2038. You have $1 billion oncology franchise right now.
When I look at that business, it looks Exelixis like, when you think about the growth trajectory of that on a standalone basis over the next decade.
Why not spin off your oncology franchise trade at $6 billion to $8 billion as a standalone company, and then keep the CNS business for yourself.
Would that be a way to maybe unlock value for the stock right now?
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JUNE 06, 2024 / 6:00PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Jefferies Healthcare Conference
Robert Iannone - Jazz Pharmaceuticals Inc - Executive Vice President, Global Head of Research And Development, Member of the Executive
Committee
The question is for Renee, but I will point out you mentioned breast cancer in zanidatamab. We've already kicked off that program that's essentially
a head to head for -- against Herceptin, where we know we have data to beat that in a field where it's really wide-open after in HER2 on third line,
potentially in second line. You also didn't mention some of the other near-term readouts we have such as first-line (inaudible).
Question: Akash Tewari - Jefferies LLC - Analyst
: Last question for you and I realize we're almost of time. Sleep, (inaudible) data, Rob, you see that type of CGI improvement, especially when patients
were washed out of sodium oxybate. There is kind of a sense where these drugs are starting to arrive. These are going to be -- you're showing a
remarkable biological signal. The question, I think, we all have is really the effect of directions on sleep architecture.
It sounds like the Takeda is sitting on some of that data. They have alluded to it at their investor event. Rob, how would you view your sodium
oxybate franchise in the end whether or narcolepsy will be an orexin sodium oxybate combo treatment? How does that change, if, let's say, an
orexin shows a meaningful benefit on sleep architecture as a standalone agent.
Robert Iannone - Jazz Pharmaceuticals Inc - Executive Vice President, Global Head of Research And Development, Member of the Executive
Committee
So we know that the root cause in narcolepsy is disrupted nighttime sleep. So the advantage of Xywav is it directly addresses that. Unlike
wake-promoting agents where you can improve some of the symptoms of narcolepsy, such as daytime sleepiness as measured by setting up our
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JUNE 06, 2024 / 6:00PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Jefferies Healthcare Conference
sleepiness scale, you don't ever correct the underlying, disrupted nighttime sleep. And it's sort of like now as a physician in training going in and
doing an overnight shift. You have a cup of coffee because it does help keep you awake, but you certainly don't feel good. It's not the same as
getting a good night's sleep.
So we think that any therapy really has to address the disrupted nighttime sleep. And in the field, while orexin agonists certainly are proving to be
the most potent wake-promoting agents, we don't yet know whether there is improvement in nighttime sleep and how that ultimately will play
out. And there certainly is even a risk for especially longer half-life drugs, have insomnia that may be counterproductive. So we continue to think
it is potentially complementary to Xywav and time will tell us the data.
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