Jazz Pharmaceuticals at TD Cowen Conference: Strategic Growth in Focus

On Wednesday, 05 March 2025, Jazz Pharmaceuticals (NASDAQ: JAZZ) presented a confident outlook at the TD Cowen 45th Annual Healthcare Conference. The company highlighted record revenues and strategic acquisitions, yet acknowledged the challenges of generic competition. Jazz’s focus on oncology and sleep disorder treatments was evident, showing both optimism and strategic foresight.

Key Takeaways

• Jazz Pharmaceuticals reported record revenues of $4.1 billion in 2024.
• The acquisition of Chimerix aims to enhance the oncology portfolio, particularly in pediatric glioma.
• ZYWAWE showed strong growth, with a 19% increase in Q4.
• The company is preparing for significant regulatory milestones in 2025.
• Expansion into breast cancer indications for XIHEREA represents a new market opportunity.

Financial Results

• Record revenues of $4.1 billion in 2024.
• ZYWAWE grew 16% for the year and 19% in the fourth quarter.
• Epidiolex is positioned to become a blockbuster, with exclusivity extending to the late 2030s.
• 2025 guidance includes the impact of authorized generics.

Operational Updates

• Acquisition of Chimerix to enhance the oncology portfolio.
• XIHEREA approved for second-line biliary tract cancer with a positive initial launch.
• Significant results from the frontline trial for ZYXELCA in small cell lung cancer.
• European approval for XIHEREA in BTC expected in Q2.
• Ongoing pivotal trials for XIHEREA in breast cancer.

Future Outlook

• Focus on securing approval for duradaviprone with a PDUFA date of August 18.
• Anticipated submission for ZYXELCA in frontline small cell lung cancer in the first half of the year.
• Expected European approval for XIHEREA in BTC in Q2.
• GEA trial readout for XIHEREA expected in the second half of the year.
• Continued growth for ZYWAWE in idiopathic hypersomnia, with strategic positioning amidst generic competition.

Q&A Highlights

• Confidence in duradaviprone approval based on extensive experience and durable responses.
• The GEA trial requires zanodetimab to outperform the control and show incremental benefits.
• Enthusiasm among physicians for XIHEREA in breast cancer, especially post-HER2 treatment.
• ZYWAWE’s low sodium content and flexible dosing are key market advantages.

For more details, readers are encouraged to refer to the full transcript of the conference call.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Joe Thome, Senior Biotech Analyst, TD Cowen: Alrighty. I think we’re going to go ahead and get started. Thank you all for joining us in the room and online for the third day of TD Cowen’s forty fifth annual healthcare conference. I am, Joe Thome, one of the senior biotech analysts here on the team at TD Cowen. It’s It’s my pleasure to have with us today, the team from Jazz Pharmaceuticals for a fireside chat.

We have EVP and CFO Phil Johnson and EVP global head of R and D and CMO Rob Unone. So thank

Phil Johnson, EVP and CFO, Jazz Pharmaceuticals: you both for joining us. Maybe just to kick things off, obviously, some news this morning, but, will

Joe Thome, Senior Biotech Analyst, TD Cowen: be great just to kind of get a high level overview of where the company sits and what investors should be looking at this year, and then we can dive into the specifics.

Phil Johnson, EVP and CFO, Jazz Pharmaceuticals: Fantastic. Thanks, Joe. It’s really an exciting time at Jazz. I’m really pleased to be here at the conference, not only have this session but to meet with investors to talk about Jazz, answer their questions and help them make some informed investment decisions. Before I get started, I do need to do some of the work here to let you know, please do consult our SEC filings, our recent earnings call for risk associated with our business.

If we do refer to 2025 guidance in this session, we’ll be referring to the guidance we gave at our recent earnings call. And then we may talk about non GAAP measures as well. Please do refer to our earnings materials for reconciliation to the corresponding GAAP measures as well. Before I get into the state of the business, which is in a really strong position, let’s talk a little bit about the announcement we had this morning. Well timed to be able to be here with you today.

I know you got some good knowledge of that company and its lead molecule as well. So Chimerix, their lead acid, dronavaprone, is targeted to H3K27M mutation in glioma that typically affects very young pediatric patients or young adult patients. Devastating disease with very poor prognosis, I think probably something like maybe twelve to fifteen months patients survive from time of diagnosis. There’s really been no advances here, presence radiation therapy, fifty, sixty years ago. So huge unmet need.

Looking forward to hopefully closing this transaction in the second quarter and then working aggressively with our new colleagues at Chimerix on getting this product approved and then out to patients and physicians. This is a great fit with our oncology business. It can leverage some of the capabilities we’ve already developed, particularly the commercial capabilities, provides us a near term launch and also an asset that can be very durable as well with patent life ascending into 02/1937 and potentially beyond with patent term extension. Please do consult the overall press release. We just put out the joint press release with Chimerix for additional details and then we’ll be I’m sure answering some questions here during the session.

In terms of the state of the business, as I said, coming off a really strong 2024, we had record revenues of $4,100,000,000 in the year. Each of our promoted brands also, had record years, really strong growth with Ziwave growing 16% for the year and 19% in the fourth quarter, really strong new patient adds in the fourth quarter, ’5 ’20 ’5. So that business continues to perform extremely well even with authorized generic competition and branded competition. Epidiolex also performed extremely well last year growing in the teens positioned to be a blockbuster this year. And we had really good news with settlements with our ANDA filers and provided some clarity for The Street for how long we’ll have for exclusivity for that product, which I think was welcome news, maybe a surprise to some that that would go out to the very late 2030s.

And then on sort of newer products coming to market, had great progress last year with the approval of and then getting initial patients treated with XIHEREA for second line biliary tract cancer. I know Rob will talk more in his remarks about the progress we’re making with XIHEREA and the great potential we see to help patients and also to generate significant revenues for Jazz and value for shareholders. So let me turn to Rob for some of your thoughts.

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: Yes. Thanks, Phil. I would love to start with the Chimerix announcement for this morning. As Phil mentioned, this is a very high unmet need cancer. I’m a pediatric oncologist by training.

Even though I look young, I finished my training in 02/2001. And there really has been no progress in this area. So I know from treating these patients that it’s been a very sad situation to have only radiation and surgery as the effect of therapy. There was a breakthrough here in identifying the H3K27M mutation as causal in a group of these diffuse high grade gliomas. Just want to spend a moment explaining how that works because I think that underlies the rationale, why we think this is going to be a very promising drug.

That mutation results in hypomethylation. So there are growth factors, growth signaling that are essentially shut off in normal cells through a methylation process. And because of this mutation, you see then lack of methylation or so called hypomethylation that then releases the growth signaling so that that becomes then the growth driver for this tumor. What’s been shown with doradaviprone is it reverses that hypomethylation and causes remethylation of those growth genes that should be suppressed in normal tissue. And that’s been the mechanism of action.

The clinical data bear that out. They’ve studied over four hundred patients. And amongst those, there was a large proportion who had this mutation. And it’s clear that the mutation is a marker for essentially frontline as well as second line. So patients who are just completing their radiation therapy then move on to get tirdavapone, very well tolerated in that setting or even some data in combination therapy settings.

In the pivotal trial, which was curated to identify those patients who truly had documented progression, for example, and then had a response and a durable response, because that is the criteria for an accelerated approval in The U. S. That you show objective responses that are durable. So So the pivotal program will be a subset of that larger sample set. And it’s past the validation period.

It’s been given priority review with a PDUFA date of this August 18. So we think this is potentially a meaningful targeted therapy for these patients who have a very poor prognosis and literally, literally no alternatives.

Joe Thome, Senior Biotech Analyst, TD Cowen: Perfect.

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: I do want to I mean, that’s the news of the day, and I I wanted to touch on that, but we’ve got a lot of other exciting stuff. So if you give me another two or three minutes, I’ll just hit a couple of highlights, and then we’ll jump into the q and a. So I do want to talk about SYBELCA. I think you all know this is our drug that’s approved in second line. It’s now the preferred treatment choice second line small cell lung cancer.

We put in place a frontline trial soon after we did this in licensing deal. And we were very thrilled to see in the fall that, at the time of the PFS analysis and the interim OS analysis, we were stat sig on both. And we’ve said that it was clinically meaningful in both and should become the new standard of care in frontline. We continue to be on track to complete that submission this half of this year. We haven’t said yet where this is going to be published, but we’re moving quickly to publish this, present it at a major Congress and publish it contemporaneously and then to move quickly to get this adopted into NCCM because we do think it’s practice changing.

Very excited about that. Zihara has been had a number of really important milestones recently. Of course, we had approval for BTC and now we have some launch under our belt, which we feel is going very well. Docs really want to use this for their BTC patients because of the transformative efficacy that we’ve seen. It’s also helpful that we’re now in the marketplace on formularies.

Docs who are prescribing for BTC will be the very same docs will be prescribing for GEA when that trial ultimately reads out. We are expecting approval in Europe for BTC. We’ve said 2Q this year, so imminent and we’re reiterating that we’re on track for that. We slightly revised timelines on the readout for the GEA trial based on the fact that it is an events driven trial. The first readout is PFS, so it’s based on progression events.

We will take an early look at OS at that point. And then we count events for OS when we do a second OS and then a final OS. We’re nearly we said we’re closing enrollment imminently. And with more mature events projections, we now have more confidence around when this should read out. So we’ve said second half of this year.

We are still waiting, counting events as they come in. And so we certainly wanted to leave open the possibility that that could be pulled into 3Q, which is essentially a quarter off what we had said previously. It’s not on the basis of enrollment. That’s gone as good or better than projected. It really does have to do with events.

And we’re extremely excited about turning that card over because we believe that, that Sahara, every time we’ve looked at data, it’s, you know, performed, outperformed, whether that be in BTC or in GEA with the two frontline Phase II trials that independently are showing fifteen point two and sixteen point seven months of median PFS compared to historical references, which should be about the eight month range. But also in breast cancer and we’re seeing activity as monotherapy, we’re seeing activity in combinations, we’re seeing activity in patients who’ve progressed on Herceptin. And so it gives us a lot of confidence that head to head with Herceptin like in the gastric trial, we should be positive. We also have two other pivotal programs, very excited that we’ve kicked off our breast cancer program. There’s a real opportunity here.

So you go from approximately twelve thousand BTC patients, sixty three thousand GEA patients, one hundred and fifty thousand breast cancer patients, U. S, Europe, Japan. So breast cancer, obviously, very big population. For those who don’t know the field, you might say, isn’t that pretty crowded? I would say it’s evolved in a way that there’s a real opportunity for Xyhara there because in HER2 now it’s entrenched in second line, it’s likely to move to front line based on the ongoing trial.

And for all the other HER2 agents, there really are no data showing efficacy in patients who’ve progressed on NR2. And there’s reasons for some of those to think that they wouldn’t perform very well in that setting. We now have a growing body of data showing efficacy after NR2, you know, being comparable recently published at San Antonio Breast Cancer Symposium and patient, a cohort of patients who all had had in HER2 showing very strong data. So we think we could be first. And right now that’s sort of a third line plus, but if in HER2 moves to frontline, it could wind up being a second line plus in a population of patients who tend to survive to their next line of therapy.

So very excited that that ultimately would play out to its favor. And we lastly started a pivotal trial in a cohort several cohorts of patients that would support a tumor agnostic indication. So for anyone who has IHC3 plus HER2, regardless of tumor type, without an approved alternative therapy would then be eligible and that trial is ongoing as well. Those are the big highlights, Joe.

Joe Thome, Senior Biotech Analyst, TD Cowen: Perfect. And as I’m sure everyone in the room is aware, CHIMEREX was our top Q1 pick for the regulatory review. So, we also like the asset. The deal is going to close in Q2. The PDUFA is in August.

So maybe can you talk a little bit about your confidence that the drug will be approved this cycle? And obviously, there’s the Phase three ongoing to move it front line. How do you think about the odds of success to move it frontline H3K27 but glioma?

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: Yes. So for me, we’ve looked at again, very large experience. We’ve looked at the data, both objective response rates, seeing some very durable responses, looking at patients who did receive it in front line where you’d expect, you know, a very short progression free interval and survival. You know, single arm data showing very encouraging results there. So we think it’s a meaningful potential treatment for patients.

We’re pleased that the FDA recognized that with priority review. There’s been no hint that there would be a need for an ad board, you know, ODAC. And so that for a fairly straightforward package that August 18 PDUFA date seems reasonable or even beatable. Whether this would get used in front line, so of course, we would never promote off label and we do expect that initial label to be in the recurrent setting. However, we’ve just had very high unmet medical need.

There really are no alternatives to this therapy. Patients universally progress on a pretty tight timeline. And so there was a lot of interest in participating, in a trial where they could give this immediately following radiation therapy as part of the frontline therapy. And that was really the inspiration for the confirmatory trial, a so called action trial that’s ongoing, which is a frontline trial and would ultimately update the label, but just showing the appetite to have that as really a first a first response rather than waiting for patients to progress who, you know, universally do and are then at a pretty challenging situation. You know, progression occurs with typically with symptomatic complications given, you know, the location of these tumors in the in the midline of the brain.

Joe Thome, Senior Biotech Analyst, TD Cowen: Perfect. And we do get probably the most questions on zanodetimab and Zaihara and GEA for the upcoming readout. Can you talk a little bit about what will be deemed in your mind or clinician’s eyes clinically meaningful in terms of an extension on PFS? And do you need to hit in both arm B and arm C in the upcoming trial?

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: Sure. So for those who may not be familiar with the trial, it’s newly diagnosed gastroesophageal adenocarcinoma who are HER2 positive by the typical ASCO cap criteria, which is IHC two plus and amplified or IHC three plus The great majority of these patients tend to be three plus In the most recent trial, that was about eighty percent. It’s designed as a three arm trial where the standard of care remains receptive chemotherapy. That’s ARM A. ARM B is zanodetimab replacing Herceptin plus the backbone chemotherapy.

And then ARM C adds to that tislelizumab, which we believe is a best in class PD-one inhibitor. And we know that for patients who overexpress PD L1, they’re likely to derive some benefit from a PD-one inhibitor. There’s been a lot of experience with this population of patients, three prior clinical trials showing the control arm to perform pretty similarly. I mentioned, you know, the best was probably eight months, the very early trial that got its approval was more like six point seven months median PFS. The most recent press in his keynote eight eleven, which actually got accelerated approval based on response rate, but when the PFS data read out, that was about a median of two months.

Ultimately, they had survival data, but the approval was based on response rate at a median about two months. In our trial, like I said, we certainly don’t necessarily expect to replicate what we’ve seen in Phase II, but I am encouraged that it’s two independent Phase IIs that are showing fifteen point two months and then incrementally better when you add tislelizumab. So pretty promising. And we as you know, we upsized the trial to ensure that we have adequate power for the overall survival analysis that will come later.

Joe Thome, Senior Biotech Analyst, TD Cowen: Maybe on that overall survival analysis, when we see the data in the back half of the year, maybe how much are will OSB and kind of how are you going to be using that when potentially taking the PFS data to the FDA?

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: Yes. I’m going to answer that, but I realized I left one of your questions on the table, which is what do you need to get approval for both? So I gave that detailed study design because certainly you need to beat the control arm to get approval. So arm B has to beat A and B Stat SIG clinically meaningful to get approval. Arm C has to be a control arm, arm A Stat SIG and B clinically meaningful.

Now for contribution to components, you wouldn’t want to add a therapy if it’s not also adding incremental efficacy. And so arm C has to be incrementally better than arm B. Yes, for efficacy, but also just an overall benefit risk when you’re talking about whatever additional toxicity you might have from that. That traditionally hasn’t had to be a statistical evaluation versus more of a consideration of the totality of the data, especially when you’re going to want to look at subgroups like PDL1. And then coming back to your other question was?

Joe Thome, Senior Biotech Analyst, TD Cowen: In terms of how mature the OS is going to be and how you’re going to use those when the

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: So the first analysis is PFS driven by PFS events. Now one of the consequences of having pushed out a little bit beyond protocol assumptions is we probably have more power for OS than we thought we would. Having said that, what’s important is that we preserve the power for the study for the longer term. So we do have a shot. The purpose of that first OS is really to support the approval based on PFS to show that there’s not a detriment, that there’s a trend in the right direction.

The second OS analysis has about the power that the original trial design would have had in its final. And so then you start to get into sort of a more meaningful probability of success. And then you have a final analysis that we think is comparably powered to other modern trials. Now having said that, powering is just a construct that relates to how big is the effect size. And so like in the ZYPSELCA trial where we weren’t expecting a stat sig OS result, you can see it if the facts big enough.

So we’ll see. That’s the nice thing about having multiple shots there.

Joe Thome, Senior Biotech Analyst, TD Cowen: And can you talk a little bit about the relative size of the GEA market versus GA market versus your initial launch indication of second line BTC?

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: So BTC is about twelve thousand patients first and second line worldwide with about when we talk about U. S, Europe and Japan with about 3,000 in The U. S. GA is substantially larger, frontline 63,000. And in frontline, you tend to get a longer duration of therapy, of course.

And then when you get the breast cancer, hundred and fifty thousand. And even if you’re in second, third, fourth line, those patients do tend to make it to subsequent lines, you know, more so than, let’s say, difficult to treat lung cancers. And so we think that becomes one of the biggest market drivers for us.

Phil Johnson, EVP and CFO, Jazz Pharmaceuticals: Similar to BTC where there’s the 12,000 Rob mentioned across those various geographies with 3,000 in The U. S. I also think GEA is similar with the 63,000 you mentioned across those major geographies and roughly eight I believe in The U. S.

Joe Thome, Senior Biotech Analyst, TD Cowen: And in the ASCO data in BTC last year, we did see that Xyhara does show maybe a slightly larger benefit in the IHC3 plus population versus two plus and the label followed that. When you think about GEA, do you expect the same thing? And what proportion of patients in the trial do you anticipate will have IHC three plus disease?

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: You know, we don’t we don’t have data from the trial to track, but we know it’s a great majority that are three plus, you know, probably similar to BTC. You know, is that eighty percent? Is it some, you know, not quite sure, but it’s a great majority of three plus anyhow. But I would say I would caution around conclusions around IHC2 plus Again, I would never promote off label or encourage this, but if I were the treating physician and I had a second line BTC patient with an amplified two plus I would use it. We just don’t have enough data to be sure it doesn’t work there.

Certainly, when you’re in a frontline setting where you’re also with combination therapy, for a tolerated drug, I think there’s, you know, there’s a reason to give it a shot to have some added benefit. So I don’t anticipate that our label would be restricted in frontline GA and I actually anticipate when we read out the frontline BTC will probably broaden the label.

Joe Thome, Senior Biotech Analyst, TD Cowen: And maybe can you talk a little bit about the opportunity in breast cancer and your work here? Obviously, you’ve shown some interesting data post in HER2. Kind of how are you thinking about zanodimab in that setting?

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: Yes. I mean, this is something that I think if you’re not working in the field, you may have missed this. But I would say, I had prior experience in breast cancer really going back for Keytruda days. But when I was at ImmunomatiX as their CMO, obviously, we worked with many breast cancer experts. I would say that the day this deal closed, you know, I was on the phone all day with breast cancer docs saying we want to work with this drug, based on the experience that they had.

And they they were observing a couple of things, very well tolerated, especially as monotherapy, highly active, you know, not in a direct comparison, but, you know, more than you’d expect even from the combination of Herceptin and Perjeta. And perceiving that while there’s a lot of excitement around INHER2, it’s not curative. And there’s gonna be a major scientific gap in terms of how do you treat a patient who’s progressed on an HER2. Remember, an HER2 is built on the Herceptin scaffold, so you’re essentially giving Herceptin with a warhead. Especially anticipating that the frontline in HER2 trial is remember a combination of in HER2 PERJETA versus in HER2 versus the so called Cleopatra regimen, which is Herceptin, Herceptin, Herceptin, chemotaxate.

So you may be in a situation where patients are getting Herceptin based plus PERJETA and then progress. And so you wouldn’t just give the frontline therapy next or at least not without having data to show that it works. And then there’s a whole host of other things you could give. But would you give TDM one, which is another ADC? Well, and HER2 kind of blew TDM1 out of the water head to head.

Would you give Tucatinib, which is certainly relied upon for BRAIN NETs, but no data in that setting after in HER2? And so the message to us was there’s a big gap here. We know your drug is working. We have accumulating body of data show it’s actually working no matter what you’ve given before. Herceptin, Perjeta, tucatinib, TDM1, now growing body of literature on and HER2 itself, which makes sense because and HER2 resistance is probably from resistance to the TOPO1 warhead.

They said, we want we want this drug as a, you know, a choice for after and HER2. And there’s been tremendous enthusiasm for doing that trial at a time where no one seems to be working in that space. There are novel ADCs that would obviously be testing after INHER2 as a salvage, but none in the pivotal space. And so it was serendipitous that we had the opportunity to get into, we have the data to do it. And ultimately the design of the trial is patient comes in, they’re assigned their chemotherapy, they’re randomized to either get to anadatumumab or septin in patients who all progressed on Herceptin and then progressed on Herceptin based ADC, it seems like a low bar to win.

And based on the data, we’re confident that it’s going to win handily and be the only asset that has data in that space. And I certainly think that, you know, for head to head intercept in naive patients with gastric and look good there, but it’s going to have

Phil Johnson, EVP and CFO, Jazz Pharmaceuticals: to look in breast cancer.

Joe Thome, Senior Biotech Analyst, TD Cowen: Perfect. And maybe we’ll jump over to the sleep franchise, maybe start on the narcolepsy side of things. What are you seeing in terms of, obviously generic Xyrem and potential competition from Lumerise as it relates to your XYwave franchise? How sticky are you able to keep your Oxivate side of things and what’s anticipated in the current guidance?

Phil Johnson, EVP and CFO, Jazz Pharmaceuticals: Yeah, so as we mentioned before, we do expect Epidiolex to grow this year, I’m sorry, XY Wave to grow this year, and we gave our guidance. We didn’t break that out between narcolepsy and idiopathic hypersomnia. Clearly we’ve said consistently the biggest growth opportunity with idiopathic hypersomnia. As I mentioned earlier, we’ve been really pleased with how well narcolepsy has held up, not just with the AG but also with Lumerise coming in as well. We do think this really speaks to the benefit that patients and physicians see to low sodium in a patient population that has an increased risk relative to the general population of cardiovascular events.

And we’ve continued to build out not only the messaging to physicians on this point, messaging to payers, but also bringing additional services that have really helped with persistency and getting patients up to a really good therapeutic dose where they’re getting good benefit from the drug through our Nurse Navigator program that’s been highly successful. So we really feel good about the position that we are in. We did say for 2025, our guidance does assume that authorized generics continue for the full year of 2025. Then there is uncertainty that will happen in 2026. That is the year that generics can come in.

Technically even Hikma could elect to come in now. They could have elected to come in last year as well. Certainly if we do have generics coming in and HIPAA would not be in the AG, that AG revenue would go away. We expect remaining Xyrem revenue to come down significantly. XYwave is the question mark.

To the extent that the market including payers are really valuing the low sodium content that we have, We think that can be a stickier franchise. And we will look forward to making strong progress this year growing that franchise position ourselves well for 26,000,000.

Joe Thome, Senior Biotech Analyst, TD Cowen: And when you think about IH, how penetrated into this market are you? Can you kind of talk about how easy it’s been to identify and treat this proportion of patients?

Phil Johnson, EVP and CFO, Jazz Pharmaceuticals: The rule is nothing for this condition before. So this is a market that we’re building over time. And it took us quite a while to build narcolepsy as well. So I think it was three thousand nine hundred patients that we had on Zywave in idiopathic hypersomnia coming out of 2024. There’s probably at least twenty seven thousand I think from the claims data we’ve seen of patients who are diagnosed and seeking treatment and then we have anecdotal data from physicians saying in their practice they actually think they have as many IH patients as they do narcolepsy patients.

So we see significant room here in The U. S. To continue to grow in IH. NIH.

Joe Thome, Senior Biotech Analyst, TD Cowen: And we have heard,

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: I just said if I I know you don’t have much time, but I do want to just come back from medical perspective. To me, Zywave has orphan exclusivity because of the high cardiovascular risk in narcolepsy patients and the FDA statement that Zywave is safer for all narcolepsy patients because of that underlying risk. So for me, the benefits of low sodium should be the main driver of treatment choice, even if all other things are equal. And nobody should be taking that amount of sodium who doesn’t have to, especially a patient with narcolepsy. Having said that, Zywave has other advantages.

It is it can be tailored and optimized by virtue of its split dose. For many people, it’s not intuitive. Why would you want to take a drug twice when if you could only take it once? In this case, actually, it’s important that you have the flexibility. You know, when I say tailored, it’s because people’s lifestyles vary day to day.

I can’t have two prescriptions, one one for Lumarize, one for Zywave. So on a on a Saturday Friday night, we’re out late and you’ve got an early morning soccer game with your child. Maybe you got to tailor it to fit that schedule versus on a on a Sunday, Saturday and Sunday, say, I really want to just sleep as well as I can, and you tailor that. Optimizing, it’s clear from the study studies we’ve done associating PK exposure of oxoBate to PSG findings, that you don’t optimize with a PK curve that looks like LumRise. If you gave XiWave once, as you can do, it’s effective but may not be optimized for a particular patient.

Being able to wake up, take that second dose to ensure that you get the maximal effect for the next period of night really ultimately gives you the best sleep. And this is the root cause of narcolepsy. You have to correct the underlying sleep in order to have relief of symptoms during the day, which is not, you know, which is, of course, sleepiness, cataplexy, but other, related symptoms. So it it can be tailored and optimized in a way where it’s it’s also the superior drug, not just the safer drug.

Joe Thome, Senior Biotech Analyst, TD Cowen: Perfect. And with that, we are at time. So congrats on all the great progress and looking forward to more.

Rob Unone, EVP, Global Head of R&D and CMO, Jazz Pharmaceuticals: Thanks for having us, Joe. Appreciate it.

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