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: 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.
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JUNE 06, 2024 / 6:00PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Jefferies Healthcare Conference
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?
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JUNE 06, 2024 / 6:00PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Jefferies Healthcare Conference
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.
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JUNE 06, 2024 / 6:00PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Jefferies Healthcare Conference
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?
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?
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?
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.
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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
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 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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