Jazz Pharmaceuticals at Needham Conference: Strategic Growth Insights

On Wednesday, 09 April 2025, Jazz Pharmaceuticals (NASDAQ: JAZZ) presented at the 24th Annual Needham Virtual Healthcare Conference. The company outlined its strategic direction, highlighting robust revenue growth and key acquisitions. While optimistic about future prospects, Jazz also addressed challenges like potential pharmaceutical tariffs.

Key Takeaways

• Jazz Pharmaceuticals reported $4.1 billion in total revenues for 2024, with strong performances across sleep, epilepsy, and oncology portfolios.
• The acquisition of Chimerix is expected to close in Q2, introducing dordavaprone, a promising treatment for diffuse glioma.
• Jazz provided 2025 revenue guidance of $4.15 to $4.4 billion, anticipating a 5% year-over-year growth.
• The company is closely monitoring potential tariffs but expects no disruption in medicine supply to U.S. patients.
• Jazz's interactions with the FDA remain positive, with ongoing reviews for Zepzelca and dordavaprone.

Financial Results

• Total Revenues: Jazz Pharmaceuticals achieved $4.1 billion in 2024.
• Portfolio Performance: Each of the sleep, epilepsy, and oncology portfolios are annualizing at over $1 billion based on fourth-quarter sales.
• Revenue Guidance: For 2025, Jazz projects revenues between $4.15 billion and $4.4 billion, reflecting approximately 5% growth.
• Epidiolex Settlement: Jazz settled with all 10 Epidiolex ANDA filers, allowing generic entry in the late 2030s.

Operational Updates

• Chimerix Acquisition: The acquisition is a strategic move to enhance Jazz's oncology portfolio, with dordavaprone as a key asset.
• Dordavaprone: This treatment for H3K27M mutant diffuse glioma has potential patent protection until 2037.
• Zepzelca sNDA: Jazz plans to submit an sNDA for Zepzelca in the first half of the year for small cell lung cancer.
• Tariff Monitoring: Jazz is preparing strategies to mitigate the impact of potential tariffs on pharmaceutical products.

Future Outlook

• Capital Allocation: Jazz is committed to long-term value creation through prudent capital management.
• FDA Interactions: The company reports no change in FDA responsiveness, maintaining a positive engagement.
• Dordavaprone PDUFA Date: Scheduled for August 18, 2025.
• GEA Trial Data: Expected in the second half of the year for zanidatumab.

Q&A Highlights

• Tariff Impact: Jazz is assessing strategies to minimize the impact of tariffs on manufacturing costs.
• Chimerix Acquisition Rationale: Dordavaprone aligns well with Jazz's focus on rare oncology spaces.
• Zanidatumab in GEA: Confidence in the Phase III study design, supported by positive Phase II data.
• Zepzelca Market Dynamics: Despite new competition, Zepzelca experienced 11% growth in 2024.

Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - 24th Annual Needham Virtual Healthcare Conference:

Ami, Host: Good afternoon, everyone. Thanks for joining the next session with Jazz Pharmaceuticals. It's my pleasure to be hosting Bruce Kossad, chairman and CEO, as well as Stephane Fodderi, who's the, therapeutic lead in oncology clinical development at Jazz. Both of you, thank you so much for taking the time to join us today.

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: Yeah. Happy to be with you. Thank you.

Ami, Host: Bruce, why don't you just kick us off with some opening remarks, and, we can drive straight into q and a. And for our listeners, feel free to send me any questions you have on the dashboard.

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: All right. Terrific. Well, thank you all for spending a few minutes with us today. As we discuss our business, I'll remind you, please do consult our SEC filings and refer to our fourth quarter and full year twenty twenty four earnings announcement on February 25 for additional information and risk factors. If we refer to guidance today, it's as of the time we provided that guidance on February 25.

And if we refer to non GAAP financial measures, please refer to our earnings disclosures for a full reconciliation to GAAP. A couple comments just entering, setting us up for a conversation here. As a reminder, we did record total revenues of 4,100,000,000.0 in 2024, including the highest ever annual revenues from each of our promoted commercial products. Our sleep, our epilepsy, and our oncology portfolios are each annualizing at over a billion dollars based on fourth quarter net product sales. And then, of course, we had some exciting developments late in the year with FDA approval for and launch of ZYHERA in its initial indication of second line BTC.

We also disclosed coming into this year that we did settle with all 10 current Epidiolex ANDA filers with agreements allowing generic entry beginning in the very late 2030s. We did provide revenue guidance for 2025 of 4.15 to 4,400,000,000.0, reflecting continued top and bottom line growth, including about 5% year over year top line growth at the midpoint. And we started 2025 in strong financial position. And and then since, that time, of course, we announced on March 5 that we entered into a definitive agreement to acquire Chimerix in an all cash deal. That acquisition should close this quarter in the second quarter pending customary closing conditions.

Chimerix's lead clinical acid is dordavaprone, a novel first in class small molecule treatment for H3K27M mutant diffuse glioma, a rare high grade brain tumor that most commonly affects children and young adults. And we believe this is a strong strategic fit with our capabilities in oncology. This provides us a potential launch this year, and would create a durable revenue opportunity with patent protection into 02/1937 with the potential to receive patent term extension if approved. And throughout the rest of 2025, you should continue to focus on our continued strong commercial execution to drive our growing and diversified revenue base and making key progress on R and D programs, including submitting an sNDA for Zepzelca in extensive stage first line small cell lung cancer in the first half of this year. That'll give us the opportunity for more patients to be treated with Zepzelca for a longer duration.

We're looking forward to presenting that data. We already said the top line was positive, but presenting that data at a medical congress that should support potential inclusion in NCCN guidelines and compendia listing. And of course, we're also looking forward to our phase three Horizon GEA o one trial data in the second half of the year for, zanidatumumab, based on an updated assessment of progression events. On the financial front, we're looking forward to continuing to be good stewards of capital focused on long term value creation. I can't resist making a comment about tariffs given what's going on in the in the world around us.

And I'll say, you know, per the communication on April 2, pharmaceuticals were among several classes of products not subject to tariffs. We certainly have seen the recent comments that those tariffs are coming for pharmaceuticals and we're closely monitoring this complex and evolving situation, including those potential sector specific tariffs. We don't expect interruption of the supply of our medicines to serve U. S. Patients and our focus will remain what it always has been, which is delivering innovative and life changing medicines to patients with serious disease.

So with that, Ami, happy to jump into your q and a.

Ami, Host: Great. Thanks, Bruce. Maybe just to follow-up on the comment related to the tariffs. As you said, they are most likely coming. What would that mean in terms of the cost of goods for the company?

Anything you can shed today with regards to dependence on countries outside The US, for pieces of the supply chain, that could be helpful. And then perhaps any comments around where IP is situated?

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: Yeah. So I'll say it's a little bit of a complex situation, and it's hard to give quantitative information given that we have yet to see a specific policy to react to. It is certainly true that we have significant revenues in The US with some of those products manufactured outside The US. You certainly can see in our, regulatory filings that we have some company owned manufacturing facilities which are outside The US, specifically in Ireland, The UK, and Italy. That doesn't mean that's the source of all of our products.

We certainly have, in some cases, manufactured some of our products, not in our own facilities, but through contract arrangements in The US. You know, there are certain things we can do in the short term to minimize impact, including where we hold inventory in the short term. I think the real question is what is the long term, implication? And and I will say that's complex to figure out too because it's unclear to us whether we're really looking at a long term rational economic policy that you should expect will stay in place forever or for many years to come or whether you're looking at things that would be subject to revision again. And, you know, it's it's difficult when you're operating a business and you're trying to make long term investment decisions, including about manufacturing capacity, you know, where to make those investments requires years to pay off.

If you look at, getting a facility outfitted up and running and regulatorily approved to supply products in a regulated industry, you can't snap your fingers and make that happen overnight. So what the right long term investment decisions are depends on your view, not only of what gets announced in the near term, but what plays out over the longer term. And I would say we'll try to be thoughtful about that. We do have IP that's outside The US as well. That's a little different.

That has to do with, you know, probably more tax implications. And again, we haven't seen anything specific to respond to yet to allow us to make a make a conclusion. I will say two two other things. It's a good time to be a company with significant revenues and cash flow and financial flexibility. I know not everyone in the industry is in that position.

And as we see impact to valuations, you've heard me say, Ami, many times over the years, I don't like it when our stock price is down, but I like it when everybody's stock price is down because if you're a net acquirer of assets, that can have implications for your ability to invest and create value over time. And again, we'll have to see how things play out over a longer term, but I'll just remind people that, you know, in general, low valuations are not a bad thing for an acquirer.

Ami, Host: Yep. That makes sense. You know, the other thing that's top of mind for investors, these days is just, all the changes that have gone on at HHS and the FDA. And, you know, as you've sort of thought about the submission for, Zepzelca, and any other interactions with the FDA, have you, seen any changes or perhaps if you can just share what, you know, experience you've had in terms of just the level of engagement with the FDA and, you know, getting feedback and such.

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: Yeah. I mean, I will say we interact with FDA very regularly across a portfolio of commercial products and R and D products. I don't think we've seen yet, any change in responsiveness of FDA. You know, we've benefited historically from the fact that a number of our products and product candidates are, you know, important treatments for patients without a lot of treatment options, and I think they've tended to go to the top of the priority list. You've seen breakthrough therapies.

You've seen early approvals. You've seen accelerated approvals, priority reviews. I would hope those things under any scenario continue to be at the top of the priority list and get the most, attention. You know, certainly a lot of what we read about in changes at FDA, you know, have to do with more senior officials, policy making groups, as opposed to sort of the core review teams. So I'm not I'm not claiming there'll be no impact, but, you know, as of yet, in terms of the the standard review process, we haven't seen an impact.

And I'll remind you that we've got different types of interactions with the FDA ahead of us. It is true that through the Chimerix acquisition, once closed, we'll be looking for, an approval of a new product, for a serious disease with a PDUFA date in August. A little different when you refer to Zepzelca and maybe even ZiHara in that, you know, once we submit a supplemental approval request for Zepzelca in frontline maintenance therapy and essential extensive stage small cell lung cancer. We'll also be presenting that data publicly. People will be able to see the data at a major medical meeting.

We'll be seeking inclusion in NCCN treatment guidelines. And with a product that's on the market, physicians will be able to use the product. It may even be reimbursed and generate revenues for us independent of getting to that FDA review process. We want to get it on label. We want to be able to promote it, which we can only do once FDA acts, but it is a little bit different because it's a drug on the market.

I make similar comments as we get to GEA with zanidatumab. We've got a product that is on the market, thanks to our approval last year. That was part of our strategy to go for biliary tract cancer second line approval first, even though it's a more limited revenue contribution, it allows us the ability to get that product on the market so that if and when we come along with data in another indication like GEA, you know, there may be the ability for people once that data's out and guidelines are updated to have access to the product and have it be reimbursed.

Ami, Host: Yeah. Okay. Let's, switch gears to Chimerix and, the asset that you've, acquired through that. You have the PDUFA date coming up in second line in August, as you just mentioned. How do we how how does one sort of think about, any kind of risks surrounding that PDUFA date?

What got you comfortable? And then also, you talk about the ongoing phase three in first line for which there's data that's gonna be reported, the interim data for that also kind of around the third quarter of the year. So, how do we sort of think about approval and then additional data in first line and parts to approval in first line, expanding the label in first line?

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: Yeah. Maybe I'll I'll start and then ask Stephane to weigh in. And it just as a reminder to people, we've announced a deal. The deal is pending. It has not closed yet.

Yes. So we're not gonna reveal any new, you know, Chimerix confidential information today. We're gonna refer to, you know, comments that have already been made in our general assessment of the asset. But, again, we think it's a great strategic fit in the rare oncology space. We'll leverage our capabilities, both on the development and the commercial, particularly the commercial side.

These patients tend to be treated in academic centers where Jazz already has a presence for Rylase. And, and again, we think it's got a good, durable profile. But, Stefan, maybe you can comment a little bit on why we're excited about this in terms of regulatory path and what we see in terms of benefits of the product?

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: Yeah. It's an exciting opportunity, again, I think, for Jazz with an additional oncology product this time. It addresses a population of patients with particularly aggressive type of brain tumor called glioma, high grade glioma. There aren't really many treatment options for those patients based on where it's primarily located in the brain and based on its growth pattern, as a matter of fact. It's located in deep structures in the midline like brainstems, so it's not easily accessible for surgery on the one hand.

On the other hand, these tumors tend to grow in infiltrative matter in to the tissue rather than forming a well defined tumor mass that you would think you could just take it out. So that doesn't work. So those patients typically get radiation therapy to the area of the tumor and then it's really a follow-up and observation and all of those patients eventually will progress and eventually die. And median survival in those patients with that standard of care is typically below one year. So dodaviprone has shown exciting results in a number of phase two studies, have been summarized in our meta analyses, and that's the basis, those data for the ongoing phase three study, as you mentioned.

PDUFA date is, as Bruce, I think, mentioned it, 08/18/2025. Darbepril did receive priority review. Positive. We also see from the clinical studies and data we have so far a positive risk benefit profile that supports the approval. Obviously, it mainly showed toxicities in the range of fatigue, headache, nausea, vomiting, predominantly grade one, two, a fairly low incidence of grade three or higher treatment emergent adverse events of around nine to ten percent, and a very low rate of discontinuations or dose reductions.

So in addition to the high unmet need, the dismal outcome with standard therapy, the very encouraging data at least from the Phase II, which are the basis for the approval and positive safety data, I would say, so adds to the confidence in terms of looking at the PDUFA date.

Ami, Host: Okay. Maybe if you could also talk about how this fits into Jazz's core capabilities in terms of, you know, kind of a rare relatively rare type of an oncology indication. And maybe if you could also speak with speak to the market opportunity, both in kind of second line and first line and how so how you see that evolve over time.

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: I mean, in general, I would say the fit is we've often gone after these serious diseases where you've got a unique treatment, either the only treatment or a differentiated treatment where you've got a narrow group of patients funneling through a relatively small group of, you know, specialist oncologists that we can reach efficiently with our with our sales force. You know, we certainly have done a nice job, I think, with with Rylase. I think we've done a nice job with Zepzelca now coming along with tardavaprone, you know, to follow on to those capabilities. Yeah. Where, you know, patients and their families are really desperate to have a treatment option that has potential.

As as Stephane said, this is a terrible diagnosis, and the prognosis is pretty inevitable with with not a lot to offer. Not everyone's gonna respond to doravaprone. We understand that. But, you know, the opportunity for some patients to have a response and maybe even a durable response is a particularly exciting development. And then in terms of, lines of therapy, Stefan, I don't know if you want to comment on that, just how it would be used in practice.

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: Yeah. So there there isn't much choice in in second line upon progression, so that is a huge unmet need. But even if you look at first line, as I said, the standard of care is pretty radiation therapy and then observation. I hope nothing happens, but something always happens in this case. It's a disease that mainly affects children and young adults.

As a matter of fact, it's obviously predominantly treated at academic centers, which is a good overlap to with acute lymphoblastic leukemia, similar in each diagnosis with huge unmet need. The phase three action trial is the first line study ongoing. You alluded to it in your previous question. That study is designed in a way that patients would get standard of care radiation therapy and then being randomized to the standard of care placebo, nothing beyond radiation therapy essentially, versus two different doses or dose regimens of dolodaviprone. So we have three arms, two investigational ones with regard to the dose and the drug.

And the standard of care on primary endpoint would be looking at PFS and OS. They should go very close with each other in RBCs where there isn't much of a choice in in subsequent lines of therapy. So so that's what's going on there. So it's both an opportunity in in the second line plus setting, but but also in particular, I would even say in the first line setting.

Ami, Host: Okay. Let's switch gears to zanidatumab. You have the approval, and and you've launched it in BTC. And, obviously, the bigger opportunity is ahead of us, particularly with the GEA ongoing Phase three where the data is expected now later this year. If you could sort of just talk about, firstly, your level of confidence around, the study with, you know, some of the expected or the unexpected longer time it has taken for the events to pan out in the study.

So maybe kind of any kind of updated comments there and what are you looking for in terms of know, what is sort of the bogey for the study compared to the current standard of care?

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: Yeah. Yeah. Thanks. So there's a number of, I think, features that that would make us confident in in the design of the study and the probability of success for the frontline study. Our three zero one study number one, we base it on clinical data from two actually independently conducted phase two studies, both sanitamab plus chemotherapy in one study and the second study with the addition of tislelizumab.

These studies also conducted in different geographies and don't overlap in that sense as well. In those studies, we reported with including recent updates at ESMO twenty twenty four median progression free survival somewhere between fifteen and sixteen point seven months, which compares actually very each one of those studies to the keynote 11 arms, if you want. I wanna make the point here also that GA, HER2 positive GA, is really driven by HER2 as the primary oncogenic driver, not necessarily primarily by PD L1 expression in a subgroup of patients and having a, as we think, superior anti HER2 drug over trastuzumab that would give us an advantage here as well. Mechanism of action, we've described it. Oftentimes in the past is fairly unique, the way zanidetamab binds to its target crosslinks receptors on the surface of cells and leads to cap formation, cluster formation, internalization, interruption of HER2HER3 activation and activation of complement dependent cytotoxicity through producing this cap folding on the top of cells that leads to the activation.

We did make, I think, important and impactful design changes as we increased the number of the patients on the 03/2001 study from seven fourteen to nine eighteen. That increase in size of the study helped us primarily to increase the powering of overall survival as a supportive endpoint, I would say, to PFS. And by doing so increases the probability of success in the study. We have a very reproducible safety record with enidetamab through the whole development program, phase one, phase two single agent in combination with various chemotherapies, chemotherapy regimens and non chemotherapy agents that has been very reproducible and highly manageable. And zanidatumab is a very flexible drug.

It's not an antibody drug conjugate that's somewhat burdened by carrying chemotherapy around. It's open to combination with very different agents. Now it's a phase three study, a randomized study with the three arms: the chemo ZANI, chemo Dublin, ZANI chemo checkpoint inhibitor triplet, and standard of care arm. It's an event driven endpoint PFS, so we need to wait for a certain number of events before we can actually do the analyses. Turned out to be that the accrual of the events was somewhat slower than expected.

That's not necessarily uncommon in similar situations. It doesn't necessarily mean anything bad for that matter. It can actually be positive and favorable sometimes and not something that worries us too much. Though we are blinded to the specifics of where those events were slower, was it the standard of care arm, was it the experimental arm, I couldn't say and we're not supposed to know this. So that's important in terms of data integrity.

But we have some confidence from historical data in terms of how the control arm most likely is going to perform. If you look at the pivotal Phase III trials in that space, starting with Toga and going all the way up to the KEYNOTE-eight 11 studies. And I think these are the big phase three randomized studies that should probably serve as the benchmarking here. The performance of the control arm trastuzumab and chemotherapy has been actually in a fairly narrow range and very predictable between, if you look at median PFS, six point seven and eight point one month. So you never are secure from surprises.

Something can always happen. But I think if you look at sort of the historical roadmap and precedent, if you will, it's probably low likelihood. And we are kind of looking at control arm expectations somewhat in that range that we saw in the KEYNOTE-eight 11 EMMATOGA study. So that's another, I think, factor to add confidence to the study as it is. In terms of PD L1 expression, this was not part of the stratification factors.

We do, however, collect those data and they will be part of a post hoc or further analyses. And we will in due time also present those data. The FDA will obviously have visibility to those as well. I want to make the point here that not all of those patients do express PD L1. The high proportion that was found came through in the KEYNOTE-eleven study of eighty five percent PD L1 expressers above the threshold of one was probably a little bit enriched and may not necessarily reflect the true proportion of PD L1 patients in this patient population.

But wherever it ends up, there is a proportion of patients who do not benefit from PD L1 and the three zero one study is set up to address those patients as well. I think primarily we have really opportunity to replace trastuzumab regardless of PD L1 status as we'd be very confident we have the better and much more superior anti HER2 drug in that circumstance.

Ami, Host: Okay. All right. That was quite thorough. Thank you, Stephane. Perhaps maybe if you could switch gears and just talk about the breast cancer opportunity, which represents, perhaps the biggest opportunity for Xanee, down the line in terms of its market size.

Where do you see it positioned within the current treatment paradigm and what is sort of the benchmark as we think about second line or third line metastatic breast?

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: Yeah. We see opportunities in breast cancer across all lines of therapy, and and that means the whole bandwidth from early breast cancer looking at new adjuvant treatment approaches all the way up to use of cenidatumab in metastatic breast cancer. As everybody is aware, we are currently running a Phase III randomized study in beta line metastatic breast cancer of cemidatumab plus chemotherapy versus trastuzumab plus chemotherapy. The special attraction of that study is not that it's another study that is somewhat placed and situated in metastatic breast cancer. And there's many studies in the past that have put themselves in place.

But I think the feature here is that we are positioning ourselves in patients who have progressed on or are intolerant to NHER2. That's a big player that causes a lot of disruptions, I think, in the metastatic breast cancer space as there are very little clinical data. And that includes all the previous regimens that have been placed HER2CLIMB and others. They don't really have included patients that have progressed on HER2. So that is an opportunity for cenidatumab to be among the first to occupy that space and show efficacy.

So why would we be confident? We do have actually experience with cenidatumab in combinations in patients who have been treated and progressed on TDXD before from actually a number of different studies. I just maybe want to highlight one study, the one most recently presented at the San Antonio Breast Conference last year, which was the combination of XANI plus Evorpasept. A small study but nevertheless with different cohorts. But in the cohort of patients with HER2 positive breast cancer, all of those patients actually had tDXD prior.

And the response rate in an otherwise heavily pretreated population median number of treatments was somewhat like six or five before. Response rate was still thirty three percent. And if you just focused on the centrally confirmed patients, up to fifty five percent. So there is evidence of activity of XANI after TDXD, and I hope that will be reflected in the phase three study. As well, we also have collaborations with iSPY in early breast cancer as you may be aware.

So that's an ongoing project in the neoadjuvant space. And to our collaboration with MD Anderson, we're also running a study with them in early breast cancer of Xeni monotherapy as well as a couple of other cohorts that combine Xeni with the relevant chemotherapies used in that space, too. We had generated, I think, very positive data in a chemotherapy free triplet as well with CDK inhibitors and endocrine therapy last year and before at San Antonio with clinical outcome data which compare very favorably to other reference studies in that space and that may offer potentially patients who do not want to go for chemotherapy who can tolerate it. Another alternative there as well. Last not least, in a study outside breast, our pan tumor study just cover also includes a breast cancer cohort post TDXT as well.

So a very broad position, I think, of Xanian breast cancer with actually good confidence inspiring data, I want to say, from phase onetwo data along the development program as well.

Ami, Host: I did wanna kind of talk about BDC, which is the indication that you have launched. Maybe if you could talk about how the launch is progressing, what sort of the initial feedback and uptake, And maybe just looking beyond later in the year, once you do have the GEA data, talk to us about how you're thinking about compendia listing and kind of when that might you know, how long that might take following the data, before physicians have the option to start using, the drug in GA?

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: So, in BTC, second line BTC, I would say the initial reception from HCPs reception from HCPs has been very positive to have this treatment option. I think we've got the right team to execute on this launch given our infrastructure. You know, there's a high overlap between that group that's diagnosing and treating BTC relative to our Zepzelca call universe. So we're in the right places to leverage our footprint. And, you know, while we expect the revenue contribution to be modest from BTC given the limited patient population, again, that does set us up for the other part of your question, Ami, which is the ability to move quickly with GEA post data.

You know, compelling data can cause NCCN to meet off cycle and update their information quickly as we saw with BTC, honestly, post approval. So, you know, we'll be looking forward with positive data to get that published quickly, get that into guidelines quickly. Maybe, Stephane, you could talk a little bit about the GEA landscape and how people might look to new data to alter practice.

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: Yeah. You look at about in in terms of HER two positive patients across The US, Europe, Japan, Sixty Three Thousand patients, about twelve thousand in The US. It's a significantly bigger population of patients compared to BTC and a little bit smaller compared to breast cancer where it's about one hundred and fifty thousand. Nevertheless, patients in great need of therapies target their primary driver for the malignancy. The bench line marks are really still the TOGA study actually, which I mentioned before for those patients who do not express PD L1 above the one plus threshold at least.

And for the PD L1 positive patients, it's still the KEYNOTE-eleven study, which still leaves room for improvement as well. So I wanna repeat what I'd said before, but I think the the the three one study fits fits very well into this picture. And and given the activity of zanidetamab and all the other variables I mentioned before, I think we're very optimistic about

Ami, Host: Okay. I wanna switch gears and and, you know, I've got the five minute warning. So, wanna switch gears and talk about Zepzelca, and you're getting ready to sort of have the submission in first line maintenance. Can you talk about what you're seeing in the small cell lung cancer market with the approval of Andeltra? How that's impacting the utilization currently?

Obviously, you you're commercializing Zepzelca in second line, but then I'm delta is also being assessed in first line maintenance in combination with durvalumab. And so, you know, in a in a sort of scenario where that combination also comes forward, how do you think about marketing Zepzelca, Vetetizo sort of against that product? How do you sort of see that market dynamic play out?

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: Well, we're seeing two different things. We're seeing the current second line market, which is where we're operating, where we do have a new competitor. Despite that, we saw excellent growth certainly through 2024, '11 percent growth despite that new entrant in the market. And Zepzelca remains the treatment of choice in that second line setting. A reminder that small cell lung cancer is frequently treated in community and outpatient centers.

Zepzelca doesn't require monitoring, while Tirlatumab requires twenty four hour inpatient hospital monitoring. Despite that, we are going to see some use, you know, particularly UC use in the academic centers. But that headwind we're experiencing with a new entrant in this space is offset by the tailwind we think we're gonna have when we can move up to the frontline setting. You know, we've obviously seen our own data even though we haven't shared it publicly yet other than that we hit both on progression free survival, but also overall survival, in the in the unwinding we had last year. We're really looking forward to presenting that data at an upcoming medical meeting and then progressing to guidelines as quickly as we can even as we pursue the FDA approval.

Ami, Host: So I I suppose, yeah. I mean, so I guess the same dynamic will go through within, do do you think kind of it would be sort of driven by the utilization of atezo in first line? Do you think that that's

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: you wanna comment a little bit on on, how our approach and our data would compare generally with how, people are treated in first line today?

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: Yeah. The the the study was conducted with atezolizumab, which has the highest penetration in in that first line extensive stage small cell lung cancer space over durvalumab. Having said that physicians are very familiar, I think, these days with almost any type of approved and available checkpoint inhibitor, you may question or ask how exchangeable they are at the end of the day. So we don't see this so much of a problem. The treatment approach, whether you use a tezelezumab or durvalumab is still the same, chemo plus checkpoint inhibitor and induction for four to six months, and then continue with the checkpoint inhibitor.

And as per our data, should be now checkpoint inhibitor to thalizumab. That's where the data is based on plus plus the lurbinectedin.

Ami, Host: Okay. I'm being told we are out of time. So, unfortunately, I would have to close our session here. Thank you so much, both of you, for taking the time to do this.

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: And,

Bruce Kossad, Chairman and CEO, Jazz Pharmaceuticals: thanks for assistance

Ami, Host: as well.

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: Thank you. Thank you.

Ami, Host: Thank you so much.

Stephane Fodderi, Therapeutic Lead in Oncology Clinical Development, Jazz Pharmaceuticals: Thank you.

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