Jazz Pharmaceuticals at Goldman Sachs Conference: Strategic Growth and Challenges

On Wednesday, 11 June 2025, Jazz Pharmaceuticals (NASDAQ:JAZZ) presented at the Goldman Sachs 46th Annual Global Healthcare Conference. The company outlined its robust growth in commercial areas like Xywav and Epidiolex while addressing challenges in its oncology segment due to shipment timing. Jazz’s strategic initiatives and a strong financial position were highlighted, with ongoing efforts to mitigate potential tariff impacts and a focus on corporate development.

Key Takeaways

• Jazz reported strong growth in Xywav and Epidiolex, despite softness in oncology.
• The company holds $2.6 billion in cash, supporting its strategic initiatives.
• Upcoming product launches and regulatory decisions are anticipated to drive future growth.
• Jazz is actively exploring corporate development opportunities and mitigating tariff impacts.
• A CEO search is underway following Bruce Cozadd’s retirement announcement.

Financial Results

Jazz Pharmaceuticals reported robust financial health, with significant growth in key areas:

• First Quarter Performance: Strong growth in Xywav and Epidiolex; oncology faced challenges due to shipment timing.
• Cash Position: The company ended the first quarter with $2.6 billion in cash.
• Operating Cash Flow: Approximately $400 million generated in the quarter.
• Revenue Diversification: Xyrem and associated AG royalty income now represent less than 10% of total revenue.
• Epidiolex ANDA Settlement: Extends the product’s durability to the late 2030s.

Operational Updates

Jazz Pharmaceuticals is advancing its product pipeline and operational strategies:

• Product Launches: Expected launches include Subzelca, prasinezumab in Europe, and dordavapril pending regulatory approval.
• ASCO Presentations: Highlighted promising data for Zubselca and zanidatumab.
• Zubselca: Priority review granted by the FDA with a PDUFA date of October 7.
• Orexin Program: Trials for JZP-441 in narcolepsy type 1 patients are underway.

Future Outlook

The company is strategically positioned for future growth:

• CEO Search: Ongoing with both internal and external candidates considered.
• Generic Entry: Generics could enter the market by January 1 next year, impacting pricing strategies.
• Zanidatumab Commercial Opportunity: Potential significant market opportunity across multiple cancer types.

Q&A Highlights

Key insights from the conference call Q&A session included:

• Zanidatumab: Clinical success hinges on the magnitude of benefit in trials.
• Xywav: The impact of generic sodium oxybates will depend on market entry strategies and payer valuation.
• Orexin Program: JZP-441 trials showed cardiovascular effects to be monitored.

Readers interested in more detailed insights are encouraged to refer to the full transcript below.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Good morning, everyone. Thanks so much for joining us. I’m Andrea Newkirk, one of the biotech analysts here at Goldman Sachs, and I’m really pleased to be joined by Phil Johnson, CFO and Rob Yunone, EVP of Global Head of R and D and CMO of Jazz. Thank you guys both for joining us this morning.

Phil Johnson, CFO, Jazz: Thanks for having us.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Maybe we’ll start at a high level here. There’s so much macro uncertainty going on right now. Maybe just talk to us about the overall business and why you continue to have confidence in the forward growth trajectory.

Phil Johnson, CFO, Jazz: Sure. So I think we’re making great progress across our main priorities, both in our commercial operations with the pipeline as well as corporate development. In the first quarter, we had really strong growth with both Xywav and our sleep business as well as Epidiolex. We had some softness in the oncology business in part because we had one fewer shipping week in the quarter. That will impact us going forward.

And then we’ve got a number of upcoming catalysts, including launches for line BTC, prasinezumab in Europe, line maintenance with Sepselka hopefully as well this year, and then obviously with the acquisition of Chimerix, dordavapril with the August PDUFA date could lead to a launch this year as well. So see good momentum on the oncology side of our business. As well, maybe leave to Rob to talk about the pipeline, but had a number of presentations, oral presentations at ASCO, highlighting progress we’re making in the pipeline there. And then on the corporate development side, we had a number of questions when Bruce had announced his retirement last year if we would place corporate development on hold until we had a new CEO named. We’d said at the time, No, that’s not the strategy of the company.

We know the kinds of assets that we’re looking for. We’ll continue to progress things from the front in this interim timeframe as well. I think many investors looked at us and said, Nah, we don’t think you’re going do that. We think you’ll actually pause things. So obviously, we did not pause things.

We feel really good about the Chimerix acquisition opportunity that we have there to benefit patients that have pretty rare aggressive form of diffuse glioma. And Rob may want to talk more about that. And we’re positioned to continue to do additional corporate development, very strong financial position. End of the first quarter, 2,600,000,000.0 in cash, about $400,000,000 in operating cash flow in the quarter. Even after we pay for Chimerix and some of the litigation settlements we had discussed, we’re in a really strong position to invest in the business, both commercial assets we have in house, pipeline assets as well as additional corporate development.

I know some of the uncertainties, there’s a number of them that have come up. Certainly, tariffs has been one that has been discussed. We think positioned the company quite well for near term potential impacts from that and identified a number of actions that we can take to buffer that impact further in the medium to longer term as well. So feel good about where the business is headed. Obviously, we’ll need to be very agile as we work through what’s been a more volatile sort of regulatory political environment.

But we’re, I think, well prepared to do that.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Maybe on that point, what actions have you taken as a company to better position yourself?

Phil Johnson, CFO, Jazz: So the sort of the main one we’ve done so far, the easiest one, is to ensure that we have sufficient finished goods inventory already here in The U. S. To serve forward demand for quite some period. At the time of our last earnings call, we’d said effectively at that time we already had enough inventory to cover demand for 2025. I think it’s safe to assume that we’re now we’ve continued that trend and we’re well covered for this year and into next year.

So we don’t anticipate if tariffs were to come, that there would be any impact in 2025 that would cause us to have to move off the guidance that we had issued before. And we’ll continue to look for ways that we can go ahead and buffer the medium term impact. One of the things we’ve already mentioned is we do have the ability to produce our largest selling product, Xywav, here in The U. S. That would effectively eliminate that impact.

And there are suppliers that we can work with for things like Epidiolex to have more production done here stateside that would further reduce the impact to us in the medium to long term.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: You mentioned Bruce’s departure or the transition that’s happening right now. Where do things stand with the CEO search? And what is the background or strategic vision that the company and the board is looking for?

Phil Johnson, CFO, Jazz: So the progress is continuing well on the search. Bruce had wanted to give the board sufficient time to go ahead and have the ability to get the right person in and not have to make a quick decision. This is a little bit different than some companies have handled the CEO search. But he said, hey, listen, I’m around at least for the next year so that the board can go ahead and conduct the search and get the right individual to lead Jazz into the future. Clearly, the board is not sharing sort of who they’re talking to, whether that’s with internal or external constituents, but it is both internal and an external search that they’re conducting.

I do think Bruce founded this company for two main reasons. One, to really have a strong impact on patients, and two, to have it be a great place to work. I think those kinds of founding principles and sort of the ethos, the culture of the company would be high up on the list for potential successors for him from the board’s perspective. Includes someone who can continue to drive the growth and transformation of the business. Five years or so ago, the company had 75% of its revenue with Xyrem.

That product and the associated AG royalty income was less than 10% in the most recent quarter. So really significant transformation and diversification of the company these past five years. I think bringing in someone who can complement the current team to continue that transformation of the company. During Rob’s tenure in particular, the company has done more and more to build earlier clinical and even preclinical capabilities, to position itself more as a biopharma company, less as sort of traditionally viewed as a spec pharma company. That kind of transformation is also important, that it continues so the company can impact patients and create significant value for shareholders.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Maybe on that point in the transformation to having much more of a focus on the R and D, Rob, let me bring you in here. We’re coming on the back of ASCO. You also had a webcast yesterday with respect to CipVelka. What did you find to be most exciting out of your data presentations there at ASCO?

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: Well, thanks for the question. I certainly feel like in my six years and that was actually my ASCO because I started just before ASCO with Jazz, the most impactful one that we’ve had with multiple presentations, but specifically three oral presentations, including on dirdavaprone, sanadatumab, and Subselka. And I would say as a headline, the lung session on Monday was really, I would say, a historic one for small cell lung cancer. And that was noted by the presenters and some of the more experienced questioners around the progress that’s been made in small cell lung cancer, you know, recently versus over the last thirty years. And a big part of that was the Amphorte results, showing that when Tibzelca is given as part of a switch maintenance regimen for extensive stage small cell lung cancer patients, that there was a meaningful overall survival and progression free survival benefit.

We expect that to become the new standard of care. I think there was good discussion around how well tolerated Zubzelca was in that setting with only six percent discontinuation due to AEs compared to three percent in the control arm, as well as the study really demonstrating the importance of being proactive in the treatment of these patients and not allowing them to progress to line before getting additional therapy upon what had been the standard of care. We’ve now said that the FDA has given us priority review for a supplemental on that with an October 7 PDUFA date, and we have submitted to NCCN in the hopes that they’ll meet off cycle and quickly adopt this into their recommendations. We were also very pleased to see updated data in line GEA, our phase two trial with Sanadanumab plus chemotherapy. For the time having mature enough overall survival data to show a median of thirty six point five months in the centrally confirmed patients where the PFS and the response rates were all consistent with prior reports.

That trial, in addition to previously published data with zanitazolizumab and chemotherapy in that frontline GEA setting, it will give us confidence for our readout later this year for frontline GEA. And then, of course, really pleased to have dirdavaprone now, as Phil mentioned, in our portfolio. I think a great fit for Jazz in terms of wanting to serve patients who have a very high unmet need in areas where we think we have fully already the capabilities to do so from a commercial and development perspective. We have a PDUFA date there for the line indication of August 18, so very exciting that’s coming up soon. And we’re pleased on the progress of the confirmatory frontline trial that would bring tridaviprone to the frontline setting.

So yeah, big ASCO for us, for sure.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Let’s dig into ZANI. So obviously, a nice update there at ASCO. And to your point, these prior studies have increased your confidence as you head into Horizon GEA. But maybe for the audience here, just remind us how this study is structured with your three arms. And what is success here?

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: So this is a three arm trial. The control arm is Herceptin and chemotherapy as the backbone. Arm B is zanadatumab on that same chemotherapy backbone, so a head to head comparison of Zanee versus Herceptin. And all the prior data preclinically, etcetera, suggests we should do very well against that. And then given how the field has evolved in terms of the potential value of PD-one inhibitor, in particular in patients who have inflamed tumors as measured by some level of baseline PD L1 expression.

The RMC is Tislelizumab, which is Bechene’s PD-one inhibitor, which I feel is a best in class PD1 inhibitor in combination with XANI and chemotherapy. In terms of what does success look like there, well, certainly we need to demonstrate that XANI is contributing to that in order to get approval for ZANI, and we also need to demonstrate that tislelizumab is incrementally contributing to any benefit compared to the control arm. You know, talk about contribution of components in that regard. You know, the the magnitude of benefit, you know, there there’s a regulatory consideration there, of course. There’s a practice consideration.

There’s a payer consideration. You know, those are all somewhat, you know, different globally. What I’d say is there has been recent precedent in in this setting. You know, there’s been three phase three trials where the control arm has actually done quite, you know, consistently in that PFS of 6.7 to 8.1 range, 8.1 being most recently with KEYNOTE-eight 11, and the precedent for approvals, you know, certainly with the trial, TOGA, and then with KEYNOTE-eight 11. KEYNOTE- Keytruda was approved, recall, on an accelerated basis from a subset of data in that trial on ORR and duration of response and then confirmed with a PFS endpoint.

Ultimately, overall survival was also added to that. So I think that gives us a reasonably good precedent for what the health authorities are looking for and what practitioners are looking for in terms of incremental benefit.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: So it’s your understanding that maybe the regulatory benefit or the magnitude of benefit is consistent with what clinicians would want to see to adopt this new treatment paradigm?

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: I think they’re generally consistent, for sure. And we feel the study we’ve said this before publicly as we change the sample size has always been well powered for PFS in terms of what would be considered a clinically meaningful benefit. When we took the study on from Zymeworks, we knew as today that it was not as well powered as it could be for overall survival. It had a sample size that was about that of keynote eight eleven, which had only two arms. And of course, this has three arms.

And so we increased the sample size from about seven fourteen to a target of nine eighteen in order to be sure that we have sufficient overall survival power, which I think is important here because now we know Keytruda has survival data that we want to be able to compare favorably to. We were able to do that without much without any really impact on the ongoing trial. We’ve maintained now two interim analyses and then a final analysis. The prior plan was two total overall survival analyses. So we’ve essentially been able to add one without really changing the target for the two.

Great.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: And how does the triplet or arm C need to perform relative to arm B? And then how does the triplet need to perform relative to the pembro triplet, recognizing people will be making cross trial comparisons? Yeah,

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: and maybe I would start with that one. It’s inevitable that we’ll make cross trial comparisons. And I understand the logic of doing that in this particular case, given where pembro is. It’ll be very important, though, to do so while understanding maybe potential differences in the patients that were enrolled or different characteristics of those patients. And one key factor is when we talk about, quote, PD L1 positive patients where KEYTRUDA has their indication remember, in the PD L1 negative patients, standard of care globally remains Herceptin It’ll be very important just to recognize that there are differences in those assays.

The assay that was developed for tislelizumab uses even a different antibody architecture as well as a slightly different scoring system. So we’ll have the ability within that trial to look at a range of PD L1 expression to really try to identify what’s optimal. It’s possible that with sanadatumab that maybe there’ll be broader activity even that was observed with pembro. But in making those cross study comparisons, it would be important to, as much as possible, compare apples to apples as you bridge between those two assays.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Do you see scope for physicians to essentially just replace Herceptin? In their pembro triplet right now, they’re using Herceptin. Is there scope for them to simply replace Herceptin with zanidatumab?

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: Sure. And we think that’s the central question of this trial is, is zanadatumab better than Herceptin as the backbone for this therapy? And we certainly believe it is based on all the prior data we have where you can do comparisons to Herceptin. We know we have activity in patients who progressed on Herceptin and Perjeta and other HER2 agents, especially in the breast cancer setting. Of course, we have the two phase IIs conducted independently in different parts of the world by Zym and Beijing.

So we think we will compare favorably there. We think that PD-1s are roughly similar. And certainly tislelizumab is approved. Prior data, I think, are very comparable, so I would consider it a best in class. I don’t see the PD-one selection as the variable here.

Now, I think there’s no reason if ZANI, tisly, and chemo shows promising results that that regimen just shouldn’t be adopted broadly by prescribers. But if there’s some reason for a prescriber, I don’t know, maybe it has to do with an approval or something else or just some preference, there’s no reason that ZANI couldn’t be combined with pembro as well. And there’s certainly the opportunity for us to do some evidence generation to kind of support that practice in combination with pembro.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Got it. And as you think about the OS endpoint here, you’ll have your interim when you have your top line data here. But how important is that to get that on the label to see significance? Do you need to have significance on the label?

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: Sure. I mean, our best understanding from talking to global health authorities is that overall survival in a stat sig manner is not required for approval, provided that the PFS benefit is large enough. It’s always the case that FDA would want to see interim OS data to ensure that there’s not a negative trend. That could happen. You know, things like this happen.

You saw that negative trend with pembro actually in the PD L1 negatives. I’m not sure exactly why, but sometimes if a drug is actually causing toxicity and no benefit, it might actually result in a detriment. So, you know, that’s our best understanding. We do think this situation is different than others that have maybe been highlighted recently, and that this is frontline therapy, where clearly there’s a strong association between PFS and OS. There’s a big difference in the time between median PFS and median OS.

And there are subsequent therapies that are highly active that could confound the measurement of OS in the context of this trial. And just because you can’t measure it to a stat sig doesn’t mean that the drug is not providing a survival benefit, you know, were you to be able to study outcomes line of therapy over line of therapy. And so generally health authorities recognize that in the frontline setting, which is different than a line setting where maybe those increments are shorter and there’s not necessarily a line drug that’s active. So that’s certainly how I’m thinking about that. Remember, the PFS will read out with the plan level maturity well ahead of when we have the full maturity on OS.

That doesn’t mean that OS can’t hit. Know, Inforte hit on the interim analysis, right? And that was because the magnitude of benefit was larger than we anticipated that it would be. So it’s certainly possible. I mean, power is, you know, an assessment of based on what you think the clinical benefit is going be.

So if it’s larger, you might turn out, hey, actually we’re more well powered than we thought we were at that or interim. But it may well be that, you know, for one arm or the other, we’re waiting on the next OS readout. And I think ultimately that while that may not be required for approval, could be important in the marketplace.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: And if the profile of ZANI holds and is consistent, maybe take the haircut to what you’ve seen in the prior trials, how do you maybe how do you quantify or maybe how are you thinking about the commercial opportunity afforded by Xanny in GEA?

Phil Johnson, CFO, Jazz: So we’ve talked overall about the potential commercial outlook for BTC, GEA, breast cancer, and then the pan tumor trial, which we see as a $2,000,000,000 plus opportunity. We have not broken down in dollar terms the numbers by BTC, breast cancer, and pan tumor. Certainly, GEA is a larger patient population to be addressed than we have with BTC currently. In the markets where we have rights to zanidatumab, you’re probably at twelve thousand patients total in BTC, and line, about three thousand of those here in The U. S.

In GEA, a much larger number, about 60,000 in total, with about 8,000 here in The U. S. In the line. So certainly a much larger opportunity relative, but we’ve not quantified it specifically in dollars.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Fair. Maybe jumping to your commercial business here. To your point, you did see nice growth in the sleep business. Maybe speak to us a little bit about the dynamics you’re seeing both in the narcolepsy and the IH patient populations as it pertains to Xywav.

Phil Johnson, CFO, Jazz: Yeah. So I’ve seen really good growth in Xywav. Been really pleased with how the product has been performing in narcolepsy. This is an area where we’ve had both branded competition for some time now as well as authorized generic competition. Despite that, we’ve continued to have net patient adds, 125 in the most recent quarter, which we think does speak to the benefit that physicians and patients see to having low sodium.

CyWA is the only product that has low sodium, and we’ve had data we’ve published that shows within six months of switching to and going on a high sodium oxybate, there’s increased incidence of new diagnosis of hypertension. So again, this is something this patient population in particular we think should be avoided, as we do look at every narcolepsy patient as a potential patient for Xywav. Narcolepsy patients, along with IH patients, have about a two to three times greater incidence of cardiovascular events, heart attack, stroke, than the general population. So certainly I think this is an important feature of Xywav and one that’s clinically meaningful for patients. FDA has recognized as such that low sodium content is safer than high sodium content oxybate, including both the brands that are available and the HE.

On the IH side, that’s where we’ve seen the most growth. In fact, the last couple of quarters, we’ve seen that growth begin to accelerate, adding three twenty five patients in this most recent quarter last year, probably averaging around two fifty a quarter. So we continue to build that market. There really was nothing available prior to Xywav for patients with idiopathic hypersomnia and really see a significant amount of additional growth there. Know, if you look at published numbers, you’ll see numbers that are roughly half as far as the size of IH market, number of patients relative to narcolepsy.

But many of the physicians who treat these patients tell us they think they have as many IH patients as narcolepsy. So we still see a lot of room for growth with IH moving forward as well. We are the only product that’s approved there and currently the only product that can be marketed for that indication given the current lay of the land from a legal perspective.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Maybe as you think about the landscape moving forward, how are you contemplating the impact of generic sodium oxybates coming onto the market?

Phil Johnson, CFO, Jazz: So with generics, there’s a couple of dynamics to keep in mind. would be effectively the generics that are not potentially offered by HICMA, and then would be HICMA. So just in terms of timing and ability to come to market, generics can come to market effectively January one of next year, uncertain if they will do that or not. If they do come to market, they’ll need to have a REMS program to facilitate distribution of the product. Hickman actually has a different dynamic.

Since 2024, they’ve been able to come to market with their own generic. If they do come to market with their own generic, that would accelerate when other generics can come, so their calculus is probably more complex. But they can only market either the AG or the generic. So let’s go to a scenario where Hickam actually is marketing a generic whenever that would occur. Clearly, our AG royalty income would go away.

We’d also expect when you have generic Xyrem available that remaining revenue, which is going to be pretty small at this point, but remaining revenue for Xyrem would go down substantially. And the question mark really is what happens to Xywav. Xywav is not AB rated to Xyrem, would not be AB rated to the generics. Think it has a significant benefit offered by the low sodium content that is meaningful from a safety perspective for these patients. But I think it will be highly dependent upon how many generics come to market, what their pricing strategy is, and how much payers also value that safety benefit that can be offered by Xywav.

So we’re planning for different scenarios. We don’t know exactly what the generics will decide to do and when, but certainly believe we’ve a strong position with Xywav to continue to serve patients with narcolepsy and IH for the years to come.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: You mentioned this, that if a generic were to come to market, they would need to establish their own REMS program. How difficult is that?

Phil Johnson, CFO, Jazz: It’s not the same as you’d normally have with the generic product coming to market. It is additional investment of time and expense and resources to put it together. It certainly is doable. Obviously, you had a branded competitor, have adult, put their program in place to support Lumerize. Their economics are probably a bit different than the generics.

So again, an additional requirement, something that they’d need to do to be able to sell the drug effectively, probably not precluding them from coming to market, but may weigh into some of their calculations on when they want to come, how many might be coming, etcetera.

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: Got it. And it’s not just standing it up. It’s obviously operating it.

Phil Johnson, CFO, Jazz: Yeah.

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: Who are prescribed, you know, there’s you have to track those patients and the regulatory oversight of that as well. K. Phil said it, but I would just also emphasize that, you know, we’re talking about generics to high sodium oxybate, whereas, you know, Xywav of course is a safer, low sodium alternative that’s considered safer for every patient with narcolepsy who has a significant increase in cardiovascular risk over time. And that’s been recognized by the FDA in its Orphan Drug Exclusivity Determination. And, you know, certainly the cardiology experts that I’ve spoken to, you know, talk about the importance of minimizing risk due to sodium intake, you know, throughout the life of a patient.

It’s not like maybe there’s an analogy to cholesterol where you don’t want to start actively managing your cholesterol after your heart attack. You want to be doing it in advance. And there is an analogy around the impact of kidney function and hypertension through lifelong increased sodium intake. So it’s a real risk factor in a population of patients who are already at elevated risk. So as that when that comes to payer conversations or as we’re doing now and prescriber and patient conversations, I think there’s a continues to be a meaningful advantage of Xywav over the high sodium oxybates.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: And as you think about the durability of this business, how does that get impacted by an orexin agonist coming to the market?

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: Yeah. So for me, it’s still pretty early days in terms of the impact orexins will have in narcolepsy or beyond. I think it’s not yet clear what the best in class profile would be and the potential risks of profiles that are suboptimal, like where there might be a longer half life and then potentially excess exposure as you head into the evening hours and throughout the night Mhmm. Where you could actually have disruption of sleep. Some of the earliest data suggests certainly that erections are not correcting root cause of narcolepsy, which is disrupted nighttime sleep, you know, less deep sleep, multiple awakenings after sleep onset, like on average 80, you know, whereas for the average person it would be a few.

Or even, you know, total sleep time, the important measurements. Very little data yet published from the orexin field. What has been published suggests that there’s actually potential for disruption, but more work to be done there. And ultimately, I think, you know, in addition to just measuring sleepiness on a patient scale, we need to measure all the symptoms of narcolepsy and the potential impact of not getting fully restored asleep at nighttime. So with having said all of that, I continue to think that Orexin will be a very potent wake promoting agent that for patients who are appropriate for Xywav and benefiting from Xywav could be complementary during the day in the same way that other wake promoting agents are used.

And you’d want to optimize that so that you don’t have residual effects into the evening.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Maybe to that point, give us an update here on your own orexin program. Sure.

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: So we have JZP-four forty one, which, as we had previously disclosed, when we pushed the doses to the highest levels in healthy volunteers to determine what our maximum effect would be on weight promotion in a healthy volunteer sleep deprived model, we saw cardiovascular effects that we would want to clearly stay away from in practice. We also saw some of the other adverse effects that were noted in the field, such as visual disturbances. And so in order to take that program forward, we feel we need a much better therapeutic margin than those maximum doses studied. We think there’s potentially an opportunity in narcolepsy type one where the exposures could be lower, a little bit akin to what Takeda has done in terms of not wanting to push their dose on a drug they feel might have hepatotox liability. So we’ve started a trial now.

It’s going to be approximately eight or 10 patients. It’s a crossover to placebo in NT1 patients where there’s a four to five week treatment duration and then a safety follow-up.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: And where do things stand with your gen?

Rob Yunone, EVP of Global Head of R and D and CMO, Jazz: So we’re still pursuing a backup program, and it’s in the preclinical space, and we haven’t yet given an update yet on the timing there. But again, still of interest to us because I personally feel that it’s not clear what the best in class agent will be, and there’s an opportunity to differentiate, particularly on the basis of having an optimal half life. I personally would much rather have a shorter half life where you might have to dose two or even three times during the day and minimize that risk of carryover effect.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Maybe in the last three minutes, much of your business we have not touched on here. But Phil, any place you want to go here with Epidiolex in terms of the tail of revenue that can now be expected given the settlements with the end filers or even Rylase and what you’re seeing in the oncology business? Bring us on Sure.

Phil Johnson, CFO, Jazz: Yeah. So definitely I think Epidiolex is one, as we had talked about earlier this year. Feel really good about the resolution with the 10 ANDA filers, including the disclosure we made on our prior earnings call that we now have the facility at the very late 2030s. You saw the stock go from probably 120ish up into the low 140s based on that news. Because the market recognized the longer durability of that franchise compared to prior expectations.

So a couple of practical implications of having gotten that resolution, certainly making sure that we’re investing appropriately behind Epidiolex to maximize benefit to patients and revenue for Jazz over this long runway that we have. And then on the corporate development side, we’ve been looking and continuing to look at opportunities to build that part of our business with additional molecules. So certainly with that longer runway and having that significant revenue, it’s a great platform for us to build upon. And then in oncology, broadly, I’d say, as I mentioned at the beginning, first quarter was affected by the number of shipping weeks that we had. Beyond that, there were a couple of dynamics that affected two of our major products there.

One was the change to pediatric ALL protocols last year by COG, where we are seeing it take a bit longer for sales of Rylase to normalize. We continue to expect that that will occur in large measure from some of the discussions we’re having with treating physicians who are saying they still expect to use asparaginase as before and to follow these protocols that don’t change the overall number of doses of asparaginase, simply the timing of when that’s administered. So therefore, if people are still taking the same amount asparaginase over time, potentially when they have hypersensitivity reactions, we’d still have the ability to have Rylase used in that setting. So look forward to that progressing as we go through 2025. No Subzelca, Rob mentioned, we really have seen and we’ve been messaging for a while the great potential that we’ve seen in that line maintenance setting and are thrilled with that we were able to present at ASCO.

We have seen a reduction in some of the or line utilization, one, as you’ve seen adoption of IMDELTRA, as you would expect with a new entrant coming in. And then more recently, with the really strong results in that limited stage line patient population from the ADRIATIC study, a delay in those patients getting to the line. Again, that will eventually sort of wash out and we will then be really focused on that line maintenance opportunity with the opportunity for some patients to also get line treatment with Stepsilica as well.

Andrea Newkirk, Biotech Analyst, Goldman Sachs: Great. Well, with that, right on time. So much, guys, for joining us.

Phil Johnson, CFO, Jazz: Thank you. Really appreciate the opportunity.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.