Jazz Pharmaceuticals plc (JAZZ) September 10, 2026 Conference Transcript

School Summit. We're thrilled today to have Jazz Pharma. Guys, maybe just give us the two-minute kind of high level, and then we can kind of get into some specific questions. We've got a lot.

Yeah, thanks, Jeff, for having us here. And before we start, I'll just mention Sam and I will be making some forward-looking comments, so please do refer to the risk factors in our SEC filings. And if we do refer to any guidance, we're referring to our most recent guidance provided in our earnings update and any non-GAAP financial measures we reference are reconciled there as well. Samantha Pierce is our chief commercial officer and be happy to give you an overview of the company.

Great. Well, thank you for inviting us and thanks for joining us today, everybody. Absolutely. So I think I would just start by really reiterating and highlighting the strong commercial performance over the last few quarters. You know, our second quarter performance was obviously very strong, our best quarter ever, $1.2 billion, double digit growth. And I think what's really encouraging about what we're seeing right now from Jazz is that performances across all of our key brands. So double digit growth across all of our key brands puts us in a really strong position. Really strong foundations when you look at Zywave, which has been our brand that has been, you know, generating really good revenues for a long time now, continues to grow strongly with 13% growth in the last quarter, still adding, you know, significant numbers of net patient ads each quarter. And even in the face of new competition, continues to perform extremely well. What we're excited about is the way that we've executed on some of those new launches as well. So the performance with Mudezo, with Zepselka, and I think that combined with the outlook for Zahira now as we launch into GEA has given us the confidence to raise our guidance for the full year in 2026. Looking ahead, we obviously are really excited about the Zahira potential. We were delighted with the label that we got in that first line metastatic GEA, and I'm sure we'll talk a little bit more about that. And I think that label, combined with the development program, has given us the confidence to raise our expectations there for Zahira to $3 to $5 billion for that asset. So a really exciting period for Jazz, a much more diversified portfolio with lots of inflection points to come. And, you know, we're excited about the future and where we can take jazz with our new kind of rare disease-focused strategy as well and some of the corp dev that we're doing there.

Great. Great background. Thanks for that, Sam. Yeah, maybe to your last point about the evolution of the portfolio. So you guys have gone from, you know, sleep primarily to, you know, now oncology, epilepsy. You've targeted, you know, sort of a natural evolution of the portfolio. Is there sort of a longer term kind of objective in terms of therapeutic focus? I know, obviously, rare is the underpinning of all of them. But I wondered if there's a longer term objective in terms of where you want to be in some of the different therapeutic areas.

Yeah, I think as we've set out our strategy at the beginning of this year, with our focus on rare disease, you're really seeing us now kind of execute and pull that strategy through. You know, we've built real strengths in rare disease, and particularly real strengths in particular therapeutic areas. So, you know, the leadership position that we have in epilepsy with Epidiolex, we're looking to build on that now with some of the corp dev deals that we've done that will enable us to leverage those strengths in epilepsy with other diseases. You know, similarly, you know, we've got strengths in rare, some of the rare oncology areas, like neuro-oncology, the deal that we did with chimerics, really enables us to leverage our rare disease capabilities there. And we'd be looking to kind of augment that with other opportunities as we can. And of course, you know, the big focus at the moment is in Zahira, which is being launched in a rare disease indication. But of course, as we look ahead to the full potential of Zahira, we're excited to take that into other the tumor types, which would include more broad, broad tumors like breast cancer, for example. So, you know, where we are at the moment, our focus very much on rare disease, we can talk about some of the corporate development deals that we've done, you know, that are really kind of strengthening our, our position there. But that's really the focus.

Let's talk about Zahira. So give us a, you know, kind of the where you are and what maybe approximate, you know, timelines for expanding the kind of the indication base. What are the growth drivers that we should be focused on the next call, you know, 12 to 24 months?

Yeah, so commercially, obviously, right now we are focused on launching well with Zahira in the first line GA segment. We were delighted with the label that we got there. And, you know, this is an opportunity for us to really leverage the strengths that we've built in launching in rare oncology. We've obviously got a team there that was built for BTC. So we have that established team. We're not expecting reimbursement headwinds. We have the permanent J code. And we've also got a lot of experience of launching in this space where academic adoption is obviously going to be very important. But what's also going to be important is that we can get a rapid adoption in the community setting as well. And this is a launch that is somewhat similar to what we succeeded to do with Zaheara in the first line maintenance segment, which was also driven by community adoption. So we're excited there to start with, and our obviously key commercial focus is really doing that well and getting to peak sales as quickly as we possibly can. Beyond that, of course, we're excited. You know, the data shows, you know, Zahira to be a really new standard of care for HER2-directed treatment. And we're excited about taking that drug into other TUMOR, other HER2-expressing tumors. You know, looking ahead, obviously, breast cancer is significantly larger. We have the study, the phase three study ongoing in metastatic breast cancer. We also have a full development program that is looking, you know, our pan-tumor program, early breast cancer, colorectal, non-small cell lung cancer. And we look at the totality of that development plan, gave us the confidence to increase the peak sales projections for Zyhera in the $3 to $5 billion range. So obviously a very, very important asset for JAS and one that we're committed to kind of maximizing the potential of.

Next milestone in the breast cancer study, we expect the top line data from that phase three study to read out second half of 27, early 28.

Yeah. Like, you know, just a general thought on what we should be looking for.

Yes, well, we'll be reporting Zahira revenues to you on a quarterly basis. And I think that's going to be, you know, the best measure of how this launch is going. We had already achieved at the point of launch into GEA. With BTC, we'd already achieved a standard of care there, you know, with more than 50% share. So everything that you see from here is really going to be driven by the GEA uptake. And, you know, some of the important things for us to be able to achieve that is obviously, you know, we are focused on ensuring that the product is adopted in those academic centers of excellence. There's already very high awareness and appreciation of these results, which are obviously very strong. As I mentioned, what's really going to be very important as well is that we ensure that community doctors also appreciate the benefits of Zyheera. And that when, you know, patients are diagnosed with a HER2-GEA, that we can support them in those moments to ensure that they're aware of Zahira and that they are, you know, considering the most appropriate treatment, of which obviously Zahira would be an option. Right.

And, you know, there's a mixed Medicare and commercial population, right? Are there differences, like, in terms of, like, pathway placement or speed or regimen across this different kind of population? And could that create an uneven early adoption? Like, how could you see, like, differences in adoption between these two kind of populations? Yeah.

So we've learned a lot from our experience with Zihira, particularly in adoption in the community setting and, you know, working with GPOs on contracting to make sure that adoption, you know, is rapid and appropriate for these patients. So, you know, we're not anticipating significant differences here. I mean, I think it's going to be important that all patients, irrespective of the channel, you know, have the opportunity to get Zihira.

And then, you know, you mentioned you got a really good label for Zahir as well, right? In terms of triplet versus doublet. Maybe talk about like the utilization you expect initially with triplet versus doublet. And especially with respect to like older or less fit patients, where do you see like, you know, the use across a different kind of patient population?

Yes. Well, when you look at the totality of the data, we believe that the most appropriate choice for patients will be the triplet regimen. You know, more than two years overall survival benefit in that regimen. We know that patients will, you know, the PFS there is long. And the fact that, you know, this treatment within the label is available to both PDL positive and PDL negative patients is a real differentiator. It's probably the first time that that's been available to both those types of patients. So and that means that obviously patients can get on treatment earlier. They don't need to have a test for PDL and, you know, patients can get the benefit of Zyhera sooner. So our communication will be very much focused on the triplet regimen. Clearly, there may be some patients for whom an immunotherapy is not appropriate, and the doublet will be available also for those patients, which also has strong efficacy associated with it. But that's going to be our focus at launch.

Question for you, maybe the last one on Sahira. When you think about the peak opportunity, I'm assuming that breast is the majority of that. How do you think about, you know, kind of the different segments over the medium to longer term?

Yes, well, GEA is a sizable part. When we talk about the three to five billion peak, you know, GEA does represent a sizable proportion of that. So that's a really important focus for us now. But clearly, breast cancer longer term is one of the largest tumor types. So, you know, as we as we kind of get towards that launch, you know, that's going to be obviously critical for us to execute well around metastatic breast. We've also got the studies in early breast cancer as well ongoing there.

But the HER2, I mean, obviously, you don't have to reinvent the wheel. I mean, there's many other tumor types, right, that are, you know, kind of longer term, good opportunities as well. I guess maybe you'd anticipate raising the peak as you get more clarity on, you know, beyond breast.

Yeah. So, you know, we have the pan-tumor trial ongoing. We've got our focus on colorectal cancer and non-small-cell lung cancer as well. I mean, we do see with Zaheer's mechanism of action and the data that we already have in hand, that Zaheer can represent a new standard of care for all her two expressing cancers.

Shant, you want to, should we go to Epidiolex?

Oh, yeah, sure.

And epilepsy. Yeah, so.

Yeah, Zepselka did have a very good quarter. You know, we're exceeding $100 million in the second quarter, 42% revenue growth. Obviously, the launch into the first line maintenance segment happened in October last year. What we have been seeing is a gradual kind of tapering down of that second line business over time with increased competition there, even, you know, before the Lagoon study readout. Our focus commercially has been 100% on the first line maintenance segment since we launched there, and we've seen really good growth. In the second quarter, revenue, if you split that down, between 30% to 40% of that revenue was being generated by that first-line maintenance segment, and that's obviously growing. So we can expect to see that second-line business continue to taper down, and we'll be focused on continuing to drive growth in that first-line maintenance segment.

Yeah, sure. Yeah. Let's talk about the, kind of the broadly, the neuro-franchise. So what are the largest maybe remaining opportunities as you look at Epidiolex across, you know, pediatric, adult, and kind of some of the long-term care settings? Wanted to get your perspective on that before we move on.

Yeah, I mean, we're really pleased with the growth that we've driven with Epidiolex in the last few quarters. We delivered 16% revenue growth in the second quarter and 14% volume growth globally. And what we're seeing there is continued opportunity for us to grow Epidiolex in the current label indications, particularly in the adult long-term care segment, where, you know, many patients there, LGS patients don't yet have a definitive diagnosis. So we've been investing in certain tools that help physicians diagnose patients with LGS so that they can be considered for Epidiolex. We also know that persistency is a hallmark of Epidiolex. Patients do tolerate the drug very well, and they stay on the drug for a long time. But we know if they get enrolled in our Jazz Cares program, which is our patient support program, they stay on drug even longer. So we've put a lot of effort into making sure that as many patients as possible can benefit from that program. So continued growth in the adult segment, continued growth as a result of persistency. One of the other strategies that we're pursuing that will support our continued penetration in the adult segment is the recent NDA capsule filing that we made. So, you know, that is a formulation that is going to be particularly beneficial for adult patients who have to take quite large volumes of the oral solution, which is a sesame oil based solution. So the capsule formulation is going to be better tolerated, more convenient for adult patients.

You mentioned about capsule formulation and, you know, you could expect that it could expand the patient pool, I guess, for epidialics. Can you talk about how you would distinguish between generally incremental kind of adult starts and improved persistence from capsule versus just conversion from the existing kind of solution patients?

Yeah, I mean, there will be a combination of both those two things. We do think there will be some conversion of, you know, oral solution patients onto the capsule, but we also do believe that the capsule formulation will provide an incremental growth opportunity, particularly in that adult segment. So, yeah, I mean, there will be an element of both of those.

Quality of the getting, and we talk about, like, the growth you could expect from capsule formulation, like, just, like, broad level.

Yeah, we haven't been specific around what that would look like. But, you know, we will absolutely, you know, we will expect to see growth in that adult segment. So more patients who otherwise might not have tolerated Epidiolex or perhaps come off treatment because of the issues of the oral solution. It's a weight based drug. So they're obviously taking quite large volumes of oral solution. And we do believe that it will expand out that opportunity for Epidiolex.

How would you say, was there another kind of barrier in terms of adoption with respect to kind of, you know, guidelines or reimbursement or access? Are there like new, you know, verticals that you could still invest in to see, you know, an uptick in growth in the next couple of years?

Access has always been very strong for Epidiolex. That's not really been a barrier. But we do believe that Epidiolex can offer benefits to patients beyond the current label indication. So we've invested in four really important clinical studies that are going to have longer term strategic upside potential for Epidiolex. We have a phase three DEE study that we've initiated. We have a study in juvenile myoclonic epilepsy, which is actually utilizing the capsule formulation. We have a study ongoing, a phase three, four study in adult LGS, providing us more data to help us penetrate that adult segment. And then we have an earlier stage focal onset seizure study. And these studies really come about the fact that, you know, having settled the Ander filers, we know that we have exclusivity out of the So it's opened up the aperture for us to make these additional more strategic investments in the continued growth of Epidiolex.

Maybe just help frame those opportunities, the new ones that you're investing in in Phase 3.

Yeah, so, I mean, they are new patient populations for us. So if you look at the Phase 3 DEE study, for example, there are about 120,000 to 150,000 U.S. patients in that particular segment. JME would be between around about 60,000 US patients. So, you know, they're quite sizable opportunities.

And staying on epilepsy, you recently made an acquisition with, you know, Actio. Maybe talk about what made like ABS-1230 a kind of compelling target and how could you use your kind of epilepsy infrastructure to kind of, you know, commercialize this product once it launches?

Yeah, from the commercial perspective, we're, you know, really, I mean, as a company, we're really excited about this acquisition. I think when Renee set out our rare disease strategy at the beginning of this year at JP Morgan, you know, we talked about where our focus wants to be, the kind of assets that we'd like to bring in that we believe are kind of jazz assets. And I think the Actio acquisition, it falls right in that sweet spot. I mean, this is an area of really high unmet medical need. And these little babies actually diagnosed with KCNT1 epilepsy, really very limited treatment options, devastating diagnosis, potentially 100 or so seizures a day. So, you know, the opportunity for us to bring an asset forward to have an impact on these little kids is obviously hugely motivating. And, you know, it gives us the opportunity to really leverage the expertise that we built in epilepsy. You know, with Epidiolex, we have the number one branded anti-seizure medication. We have a fabulous team. You know, the opportunity for us to leverage those capabilities with a new asset like this. And also, obviously, with significant commercial synergies is exactly the type of deal I think that Jazz should be doing.

How would you characterize, I mean, just given the presentation of these kids, I don't think you have to really raise awareness, but talk about this as maybe a global opportunity. What is the, you know, market? So U.S., what's the visibility of KC&T1?

Yeah, I mean, it's a little early for us to go into a lot of detail on this. Obviously, the deal still needs to close. But in the US, there are around two and a half thousand patients that are diagnosed with KCNT1 epilepsy. And the prevalence, I think, is similar, you know, outside of the US as well. So, you know, clearly, this is an exciting global opportunity for JAS. You know, testing in this space is reflexive already. It's done, you know, for the kids with epilepsy that will get this test. I'm sure as we dig into this, there'll be, you know, opportunities for us to understand, you know, clearly how we can really leverage the rare disease capabilities that we have at JAS with the patient support focus that we have, you know, the support that we have and the connectivity with patient advocacy groups and the patient communities in general. But that's another reason why I think this is a really perfect fit for Jazz.

And then you mentioned genetic testing, like, I know launch maybe is a year or two ahead, but maybe talk about the kind of infrastructure you have to build ahead of, you know, the potential launch in terms of like patient finding infrastructure or, you know, diagnosis and, you know, things like that. And then is there a possibility to kind of improve the kind of diagnosis or awareness in Yeah,

I think many of the areas that JAWS operates in now, obviously, with a rare disease focus, you know, patient identification is a core capability and one that we've been investing in significantly. It's going to be relevant for Actio ABS 1230, as it is relevant for Midezo, and it's relevant for Zahira, actually, and GEA. So those kind of patient identification capabilities we're building and we're leveraging right now, and we will certainly We leverage that for this launch as well. You know, testing is a key part of that. And often there is an opportunity to kind of improve the timeliness of the testing to enable that patients, you know, can access treatment early on. But these are all things that we will, you know, dig into as we get as we get our hands on the asset fully and get closer to launch.

And maybe we can move to Zyweb. Maybe talk about like the competition there. And, you know, you mentioned you haven't seen that much impact, like you are getting new patients start. So maybe just talk high level of what you're seeing in the market.

For which brand, sorry?

Zywave.

For Zywave, yeah. Yes, for Zywave, we're very happy with the durability and the resilience of Zywave. Continues, you know, second quarter was another great quarter for Zywave. You know, continued really strong growth, 13% growth, 525 net patient ads. You know, as we started this year, there were many question marks around that. You know, would we continue to be able to grow Zywave? And I think we've answered those questions. And I think that's all based around, you know, the differentiation that we've established in the minds of physicians and with patients on the importance of having that low sodium option, which has withstood the pressure from the high sodium generics, I think, really, really well. So I think we understand, you know, that aspect of the market much better now. And we're very confident in our position vis-a-vis the generics. Obviously, as we look ahead, you know, we have new competitors coming into the market with orexins as well that, you know, potentially provide, you know, a potent daytime alerting agent for patients. Still some questions to be answered there around, you know, the dosing, the half-life, you know, the impact on nighttime sleep. And we know Xywave is an important agent for, you know, disrupted nighttime sleep. There's certainly scientifically and clinically, you know, a reason, and we've heard from doctors how that they may be excited to use these, that they may see them as a complementary agent used together. Obviously, we don't yet know how these agents will be priced and whether payers will support combination therapy. But certainly from a scientific point of view, that seems possible. We don't anticipate, we have a really strong stable base of ZyWave patients. We're not anticipating that those patients would be switched away from ZyWave onto anorexin. But obviously, with a new option in the market, there could be some delay in the time that it takes for patients to maybe get to ZyWave. So we may in time see some impact on the pace with which we add patients onto the ZyWave.

You just mean in the form of maybe broader step edits through generics?

Yes, not necessarily through generics, but, you know, with the orexins on the market, could there be a delay in the time that it takes for a pay? I mean, they already work through other daytime alerting agents today often. So with orexin, maybe, you know, they're working through an orexin and maybe take longer to get the eye wave. That could be one impact that we see.

Maybe frame how IH is a little subtly with the nuances of the opportunity there and the same idea with regard to competition.

Yeah, so Zywave remains the only licensed product for idiopathic hypersomnia, and this is the area of business that we've seen particularly strong growth. If you look at the new patient ads over the last few quarters, roughly two-thirds of them have been coming from IH. So, you know, really still strong momentum there. And this is a market that is, you know, very large. You know, there's, I believe, 37,000 patients diagnosed with IH, only 9,000 of them on treatment. So there's a lot of room for us to continue to drive growth within the IH segment. And the actual overall prevalent undiagnosed population, you know, could be significantly larger as well. So when you look at the kind of patient funnel, there's lots of opportunities for us to impact the numbers of patients that are diagnosed and the numbers of patients that get treated. And, you know, given the fact that we are still the only labeled option here, that gives us, you know, gives us a lot to work with.

Maybe going back to your point on, you know, Zyweb and Dorex and Zelda might kind of delay the use of Zyweb. Maybe talk about kind of the time it can take to, you know, get on Zyweb and what kind of peer sequencing that could create with like a commercial risk for Zyweb. I mean, could there be like an op, like, you know, a possibility that other commercial products would delay, but, you know, it would be like a longer delay kind of for the patients to get on Zywave?

Yeah. Well, I mean, even with the erexins coming on the market with the multisource generics, we believe that Zywave is going to continue to have a really important place in treatment for these patients. We know the importance of improving the sleep architecture, managing the disrupted nighttime sleep. And really, Xywave is a product that kind of does that, you know, exceptionally well. So with orexins coming into the market, it does give more options for that kind of daytime piece. And, you know, the time that it takes, it can vary significantly for patients as they move through on their patient journey towards ZyWave. So, you know, there could be an impact there on that patient journey as you insert orexin into that journey, which is what I was mentioning before. But we do believe that many patients ultimately will still need ZyWave. Um, and we know that when patients are established on Zywave, you know, they do, um, they do do very well on the treatment and we invest a lot in ensuring that, you know, patients are onboarded onto treatment well with our patient support programs, uh, and that they can maintain, um, on treatment successfully for, for a long period of time.

Are you good on, on, on, okay. Yeah. Maybe let's talk a, maybe bigger picture on, uh, on BD and, and, um, anyway, obviously, um, the, uh, Actio deal. You still have to close, but talk a little bit about, you know, the capacity, you know, what the sub-therapeutic areas. Obviously, you're going to, you know, continue with the core verticals, but what opportunities are kind of you guys seeing? How should we think about, you know, the size and scale and maybe the appetite?

John, do you want to take that one? Sure, happy to. Thank you. Yeah, so the focus is on Rare and those verticals that we have expertise in, epilepsy, sleep, oncology. And if you look over the past 12 to 18 months, we've done several deals sort of in that category, which I think are good proxies for the kind of deals you could look for us to do going forward. So we did a deal with Saniona, early stage epilepsy deal. We acquired Chimerics, which is how we brought the Medeso asset into the company. We did a deal with Abselra earlier this year for T-cell engagers, and then we've just completed the Actio deal. So those are all the kinds of deals we've done, and we've got a very strong balance sheet, and so we've got the capacity to look for more deals in that category. We'd also be open to looking in rare disease outside of our core areas of competency. If we do do that, we're less likely to go early in development. We're going to want to make sure we're past proof of concept, at least probably if we go outside those three earlier, three core areas. And if we're doing more deals in those core areas, you can look for sort of a wider lens of early stage, late stage licensing, acquisition, etc. But we're still very active. We're seeing a lot of substrate, especially in epilepsy and oncology in particular. So you should expect to see more from Jazz.

Maybe on a follow-up on that, you mentioned your focus is on rare disease at this point. But with Zahara now, at some point, you'll be in breast cancer, colorectal cancer, which is not rare. But would that change your strategy in terms of what kind of assets you would acquire in the future?

Yeah, it's a great question. It's a very happy circumstance that we find ourselves in with Zahara. And when we do, if we do in the future find ourselves with an asset that has that broader potential, we're going to look to fully maximize it the way we are with Zahara. So our focus is on rare disease assets, but if we do find ourselves with an asset that looks like it has some broader potential, we'll absolutely lean into that, whether it's ourselves developing it through partnerships, whatever makes the most sense for the asset.

And just as you think about, you know, deals from a sourcing perspective, is there, obviously, there's been a big focus on Chinese assets, which is given minimal up front, but, you know, sort of a placeholder in the pipeline. Is there a mechanism or is there a geography that, you know, you guys would kind of tilt into, or is it just, you know, related to the core indications?

I think the primary driver is, is it a good strategic fit for the company with our rare disease strategy? And then, you know, we look at things like where is our commercial footprint? And Sam talked about some of the leverage we're going to get with the Actio product in terms of the existing infrastructure we have. So if there are overlays like that, that can be particularly attractive, but we don't have any limits in terms of, you know, geography or where we're looking. We're casting a wide net and looking for anything that would be a good strategic fit for us. Okay.

And last question, we've done this to a few companies, just sort of boilerplate kind of AI type of question. So maybe talk about how that, you know, what sort of utilization has Jazz really done to deploy that? Other efficiency gains, like looking through to maximize commercial, like what are the kind of things that you guys have done?

Yeah, maybe I'll start sort of at a company-wide level, and Sam can talk a little bit more about the commercial organization. But we're leaning very heavily into the opportunities that AI has to increase efficiency for our teams. So it's a tool that we are very active around. We have utilization goals at the company where we really want to make sure that we're getting the most out of what AI can offer us. And then within each functional area, whether it's finance, commercial, clinical, they're all specific use cases that we're leaning into. And Sam, maybe you can talk about the commercial organization in particular.

Yeah, well, we've made a very specific investment in this space, having set up a new part of our commercial organization, which is focused on the customer experience. And, you know, this is really important, particularly in rare disease where, you know, we want to leverage data, leverage AI and the digital capabilities to make sure that we can identify patients really well, that we can use predictive algorithms to understand, you know, where they might show up and also where they might be at risk of dropping off treatment. A good example is with Zywave, where we know we're using AI and predictive algorithms to understand, you know, after a patient has been on treatment for a certain amount of time, we kind of know using these capabilities when they might be at risk of falling off treatment, and therefore we can support them with our patient support programs to stay on treatment. You know, similarly with Zihira, it's a rare disease, and the treatment in community is pretty fragmented. So we're using AI and data, and again, to understand when and where patients are being diagnosed, and then using our kind of systems and next best actions with the sales teams to ensure that we can support physicians to be there in those moments that matter. So there's a whole suite of capabilities that we're building that are going to enable us to give the best possible experience to customers that in the end is going to help drive good patient outcomes too.

Thank you, guys.

Thank you.