Cool summit. We're thrilled today to have Jazz Pharmaceuticals. Guys, maybe just give us the two-minute high level, and then we can get into some specific questions. We got a lot.
Yeah. Thanks, Geoff, for having us here. Before we start, I'll just mention, Sam and I'll be making some forward-looking comments, so please do refer to the risk factors in our SEC filings. 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 Pearce 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. I think I would just start by really reiterating and highlighting the strong commercial performance over the last few quarters. Our second quarter performance was obviously very strong. Our best quarter ever, $1.2 billion, double-digit growth. I think what's really encouraging about what we're seeing right now from Jazz is that performance is across all of our key brands. Double-digit growth across all of our key brands puts us in a really strong position. Really strong foundations when you look at XYWAV, which has been our brand that has been generating really good revenues for a long time now. Continues to grow strongly with 13% growth in the last quarter. Still adding significant numbers of net patient adds each quarter. 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. The performance with dordaviprone, with Zepzelca, and I think that combined with the outlook for Ziihera 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 Ziihera potential. We were delighted with the label that we got in first-line metastatic GEA, and I'm sure we'll talk a little bit more about that. I think that label, combined with the development program, has given us the confidence to raise our expectations there for Ziihera to $3 billion-$5 billion for that asset. So a really exciting period for Jazz. A much more diversified portfolio with lots of inflection points to come.
We are excited about the future and where we can take Jazz with our new rare disease-focused strategy as well, and some of the corp dev that we are doing there.
Great. Great background. Thanks for that, Sam. Maybe to your last point about the evolution of the portfolio. You guys have gone from sleep primarily to now oncology, epilepsy. You have targeted sort of a natural evolution of the portfolio. Is there a longer-term objective in terms of therapeutic focus? I know obviously rare is the underpinning of all of them, but I wondered if there is a longer-term objective in terms of where you want to be in some of the different therapeutic areas.
Yeah, I think as we have set out our strategy at the beginning of this year with our focus on rare disease, you are really seeing us now execute and pull that strategy through. We have built real strengths in rare disease, and particularly real strengths in particular therapeutic areas. So, the leadership position that we have in epilepsy with Epidiolex, we are looking to build on that now with some of the corp dev deals that we have done that will enable us to leverage those strengths in epilepsy with other assets.
Similarly, we've got strengths in some of the rare oncology areas, like neuro-oncology. The deal that we did with Chimerix really enables us to leverage our rare disease capabilities there, and we'd be looking to augment that with other opportunities as we can. And of course, the big focus at the moment is in Ziihera, which is being launched in a rare disease indication. But of course, as we look ahead to the full potential of Ziihera, we're excited to take that into other tumor types, which would include more broad tumors, like breast cancer, for example. So 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 that are really strengthening our position there. But that's really the focus.
Let's talk about Ziihera. So give us a where you are and maybe approximate timelines for expanding the indication base. What are the growth drivers that we should be focused on in the next, 12- 24 months?
Yeah. So commercially, obviously right now we are focused on launching well with Ziihera in the first-line GEA segment. We were delighted with the label that we got there. And 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 Ziihera in the first-line maintenance segment, which was also driven by community adoption.
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. The data shows Ziihera to be a really new standard of care for HER2 directed treatment, and we're excited about taking that drug into other HER2 expressing tumors. Looking ahead, obviously breast cancer is significantly larger. We have the phase III study ongoing in metastatic breast cancer. We also have a full development program that is looking, 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 Ziihera in the $3 billion- $5 billion range. Obviously a very important asset for Jazz and one that we're committed to maximizing the potential of.
Next milestone in the breast cancer study, we expect the top-line data from that phase III study to read out second half of 2027, early 2028.
On GEA launch for Ziihera, you mentioned that you expect a rapid kind of uptake, because you have a 90% prescriber overlap with BTC and permanent J-code, and you expect limited payer friction. Maybe talk about high level over the next three to six months, what should investors be looking for in terms of launch metrics that would indicate that launch is getting ahead of expectations or just a general thought on what we should be looking for?
Yes. Well, we'll be reporting Ziihera revenues to you on a quarterly basis, and I think that's going to be the best measure of how this launch is going. We had already achieved the point of launch into GEA. With BTC, we'd already achieved a standard of care there, with more than 50% share. So everything that you see from here is really going to be driven by the GEA uptake. And some of the important things for us to be able to achieve there is obviously, 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 Ziihera, and that when patients are diagnosed with a HER2 GEA, that we can support them in those moments to ensure that they're aware of Ziihera and that they are considering the most appropriate treatments, of which obviously Ziihera would be an option.
Right. There's a mixed Medicare and commercial population, right? Are there differences in terms of pathway placement or speed or regimen across this different kind of population, and could that create an uneven early adoption? How could you see differences in adoption between these two kind of populations?
Yeah. We've learned a lot from our experience with Ziihera, particularly in the adoption in the community setting and working with GPOs on contracting to make sure that adoption is rapid and appropriate for these patients. We're not anticipating significant differences here. I think it's going to be important that all patients, irrespective of the channel, have the opportunity to get Ziihera.
Then, you mentioned you got a really good label for Ziihera as well, right? In terms of triplet versus doublet. Maybe talk about the utilization you expect initially with triplet versus doublet and, especially with respect to older or less fit patients, where do you see the use across different kind of patient population?
Yes. When you look at the totality of the data, we believe that the most appropriate choice for patients will be the triplet regimen. More than two years overall survival benefit in that regimen. We know that patients will, the PFS there is long. The fact that this treatment within the label is available to both PD-L1 positive and PD-L1 negative patients is a real differentiator. It's probably the first time that's been available to both those types of patients. That means that obviously patients can get on treatment earlier. They don't need to have a test for PD-L1, and patients can get the benefit of Ziihera sooner. 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. That's going to be our focus at launch.
Question for you, maybe the last one on Ziihera. When you think about the peak opportunity, I'm assuming that breast is the majority of that. How do you think about the different segments over the medium to longer term?
Yes. GEA is a sizable part. When we talk about the $3 billion-$5 billion peak, GEA does represent a sizable proportion of that, so that's a really important focus for us now. Clearly, breast cancer longer term, is one of the largest tumor types. As we get towards that launch, 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 that HER2, obviously you do not have to reinvent the wheel. There are many other tumor types that are kind of longer term good opportunities as well. I guess maybe you would anticipate raising the peak as you get more clarity beyond breast?
Yeah. So, we have the pan-tumor trial ongoing. We have got our focus on colorectal cancer and non-small cell lung cancer as well. We do see with Ziihera's mechanism of action and the data that we already have in hand, that Ziihera can represent a new standard of care for all HER2 expressing cancers.
Yep. Shaun, should we go to Epidiolex?
Oh, yeah, sure.
And epilepsy. Yeah, so give it.
Yeah. We can ask about Zepzelca. Maybe talk about it has a good quarter this year. Second quarter, maybe how quickly can you see the first-line build offset the erosion of the historical second-line business? How do you see the first-line, second-line dynamic play out within Zepzelca?
Yeah, Zepzelca did have a very good quarter. We are 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 tapering down of that second-line business over time, with increased competition there, even before the LAGOON study readout. Our focus commercially has been 100% on the first-line maintenance segment since we launched there, and we have seen really good growth. In the second quarter revenue, if you split that down, between 30%- 40% of that revenue was being generated by that first-line maintenance segment, and that is obviously growing. So we can expect to see that second-line business continue to taper down, and we will be focused on continuing to drive growth in that first-line maintenance segment.
Yeah, sure. Let us talk about the neuro franchise. So what are the largest maybe remaining opportunities as you look at Epidiolex across pediatric, adult, and some of the long-term care settings? I want to get your perspective on that before we move on to neuro.
Yeah. 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. 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 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 JazzCares program, which is our patient support program, they stay on drug even longer.
We 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. 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 could expect that it could expand the patient pool, I guess, for Epidiolex. Can you talk about how you would distinguish between genuinely incremental adult starts and improved persistence from capsule versus just conversion from the existing solution patients?
Yeah. There will be a combination of both those two things. We do think there will be some conversion of 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, there will be elements of both of those.
Qualitatively, can you maybe talk about the growth you could expect from capsule formulation, just broad level?
Yeah. We haven't been specific around what that would look like, but 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. We do believe that it will expand out that opportunity for Epidiolex.
How would you say, was there another barrier in terms of adoption with respect to guidelines or reimbursement or access? Are there new verticals that you could still invest in to see 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. 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 III 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 III, for study in adult LGS, providing us more data to help us penetrate that adult segment. Then we have an earlier stage focal onset seizure study. These studies really come about the fact that having settled the ANDA filers, we know that we have exclusivity out to the late 2030s.
It 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 are investing in in phase III.
Yeah. They are new patient populations for us. If you look at the phase III DEE study, for example, there are about 120,000- 150,000 U.S. patients in that particular segment. JME would be between around about 60,000 U.S. patients. They are quite sizable opportunities.
Staying on epilepsy, you recently made an acquisition with Actio. Maybe talk about what made ABS-1230 a compelling target, and how could you use your epilepsy infrastructure to commercialize this product once it launches?
Yeah. From the commercial perspective, as a company, we are really excited about this acquisition. I think when Renee set out our rare disease strategy at the beginning of this year at JP Morgan, we talked about where our focus wants to be, the kind of assets that we would like to bring in that we believe are Jazz assets. I think the Actio acquisition, it falls right in that sweet spot. This is an area of really high unmet medical need. These little babies actually diagnosed with KCNT1 epilepsy, really very limited treatment options, devastating diagnosis, potentially 100 or so seizures a day. The opportunity for us to bring an asset forward to have an impact on these little kids is obviously hugely motivating. It gives us the opportunity to really leverage the expertise that we have built in epilepsy.
With Epidiolex, we have the number one branded anti-seizure medication. We have a fabulous team. 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, just given the presentation of these kids, I do not think you have to really raise awareness, but talk about this as maybe a global opportunity. What is the market, so U.S., what is the visibility of KCNT1?
Yeah. It is a little early for us to go into a lot of detail on this. Obviously, the deal still needs to close. But in the U.S., there are around 2,500 patients that are diagnosed with KCNT1 epilepsy. The prevalence, I think, is similar outside of the U.S. as well. So, clearly, this is an exciting global opportunity for Jazz. Testing in this space is reflexive already. It is done for the kids with epilepsy that will get this test. I am sure as we dig into this, there will be opportunities for us to understand clearly how we can really leverage the rare disease capabilities that we have at Jazz with the patient support focus that we have, the support that we have, and the connectivity with patient advocacy groups and the patient communities in general.
But that is another reason why I think this is a really perfect fit for Jazz.
Yeah. You mentioned genetic testing. I know launch maybe is a year or two ahead, but maybe talk about the kind of infrastructure you have to build ahead of the potential launch in terms of patient-finding infrastructure or diagnosis and things like that. Is there a possibility to improve the kind of diagnosis or awareness in that regard before?
I think many of the areas that Jazz operates in now, obviously with a rare disease focus, 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 midazo, and it's relevant for Ziihera, actually, and GEA. So those kind of patient identification capabilities we're building and we're leveraging right now, and we will certainly leverage that for this launch as well. Testing is a key part of that, and often there is an opportunity to improve the timeliness of the testing to enable that patients can access treatment early on. But these are all things that we will dig into as we get our hands on the asset fully and get closer to launch.
Maybe we can move to XYWAV. Maybe talk about the competition there. You mentioned you haven't seen that much impact, like you are getting new patient starts, so maybe just talk high level of what you're seeing in the market.
For which brand, sorry?
XYWAV.
For XYWAV.
XYWAV, yeah.
Uh-huh. Yeah. Yes. For XYWAV, we're very happy with the durability and the resilience of XYWAV continues. Second quarter was another great quarter for XYWAV. Continued really strong growth, 13% growth, 525 net patient adds. As we started this year, there were many question marks around that. Would we continue to be able to grow XYWAV? I think we've answered those questions, and I think that's all based around 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. I think we understand that aspect of the market much better now, and we're very confident in our position vis-à-vis the generics.
Obviously, as we look ahead, we have new competitors coming into the market with orexins as well, that potentially provide a potent daytime alerting agent for patients. Still some questions to be answered there around the dosing, the half-life, the impact on nighttime sleep. We know XYWAV is an important agent for disrupted nighttime sleep. There's certainly scientifically and clinically 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 have a really strong, stable base of XYWAV patients. We're not anticipating that those patients would be switched away from XYWAV onto an orexin.
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 XYWAV. So we may, in time, see some impact there on the pace with which we add patients onto the XYWAV.
You just mean in the form of maybe broader step edits through generics?
Yes.
Okay.
Not necessarily through generics, but with the orexins on the market, could there be a delay in the time that it takes for a pay? They already work through other daytime alerting agents today often. With orexin, maybe they are working through an orexin, it may take longer to get XYWAV, that could be one impact that we see.
Maybe frame how IH is a little subtly, what the nuances of the opportunity there and the same idea with regard to competition.
Yeah. XYWAV 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 adds over the last few quarters, roughly two-thirds of them have been coming from IH. So really still strong momentum there. This is a market that is very large. 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. The actual overall prevalent undiagnosed population 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 given the fact that we are still the only labeled option here that gives us a lot to work with.
Maybe going back to your point on XYWAV kind of directions, others might kind of delay the use of XYWAV. Maybe talk about the time it can take to get on XYWAV and what kind of PR sequencing that could create with a commercial risk for XYWAV. Could there be a possibility that other commercial products would delay, but it would be a longer delay for the patients to get on XYWAV.
Yeah. Even with the orexins coming on the market, with the multi-source generics, we believe that XYWAV 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, XYWAV is a product that kind of does that exceptionally well. So with orexins coming into the market, it does give more options for that kind of daytime piece. And the time that it takes, it can vary significantly for patients as they move through on their patient journey towards XYWAV. So 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 XYWAV.
And we know that when patients are established on XYWAV, they do very well on the treatment. And we invest a lot in ensuring that patients are onboarded onto treatment well with our patient support programs, and that they can maintain on treatment successfully for a long period of time.
Are you good on neuro ? Okay. Yeah. Maybe let's talk maybe bigger picture on BD and, I know obviously, the Actio deal still has to close, but talk a little bit about the capacity, the therapeutic areas. Obviously, you're going to continue with the core verticals, but what opportunities are you guys seeing? How should we think about the size and scale and maybe the appetite?
John, do you want to take that one?
Sure. Happy to. Yeah, the focus is on rare and those verticals that we have expertise in, epilepsy, sleep, oncology. If you look over the past 12- 18 months, we've done several deals in that category, which I think are good proxies for the kind of deals you could look for us to do going forward. We did a deal with Saniona, early-stage epilepsy deal.
We acquired Chimerix, which is how we brought the Zepzelca asset into the company. We did a deal with AbCellera earlier this year for T cell engagers, and then we've just completed the Actio deal. Those are all the kinds of deals we've done, and we've got a very strong balance sheet, 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 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 core areas. If we're doing more deals in those core areas, you can look for a wider lens of early stage, late stage, licensing, acquisition, et cetera.
We are still very active. We are seeing a lot of substrate, especially in epilepsy and oncology in particular. You should expect to see more from Jazz.
Maybe on follow-up on that, you mentioned your focus is on rare disease at this point, but with Ziihera now, at some point you will be in breast cancer or colorectal cancer, which is not rare. Would that change your strategy in terms of what kind of assets you would acquire in future?
Yeah, it is a great question, and it is a very happy circumstance that we find ourselves in with Ziihera. When we do, if we do in the future find ourselves with an asset that has that broader potential, we are going to look to fully maximize it the way we are with Ziihera. 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 will absolutely lean into that, whether it is ourselves developing it through partnerships, whatever makes the most sense for the asset.
Just as you think about deals from a sourcing perspective, obviously there has been a big focus on Chinese assets, which is given minimal upfront, but sort of a placeholder in the pipeline. Is there a mechanism or is there a geography that you guys would kind of tilt into, or is it just related to the core indications?
I think the primary driver is it a good strategic fit for the company with our rare disease strategy? Then, 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 can be particularly attractive, but we don't have any limits in terms of 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. Last question, we've done this to a few companies, just sort of boilerplate kind of AI type of question. So maybe talk about what sort of utilization has Jazz really done to deploy that. Are there efficiency gains, like looking through to maximize commercial? What are the kind of things that you guys have done?
Yeah, maybe I'll start at a company-wide level, and Sam can talk a little bit more about the commercial organization. We're leaning very heavily into the opportunities that AI has to increase efficiency for our team. 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. Then within each functional area, whether it's finance, commercial, clinical, they're all specific use cases that we're leaning into. 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. This is really important, particularly in rare disease, where 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 where they might show up, and also where they might be at risk of dropping off treatment. Good example is with XYWAV, where we know we're using AI and predictive algorithms to understand, 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.
Similarly with Ziihera, it's a rare disease, and the treatment in community is pretty fragmented. So we're using AI and data, and again, these 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. 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.
Thanks .