Jazz Pharmaceuticals (JAZZ) Q2 2026 earnings call transcript

Thank you, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its second quarter, 2026 financial results. The slide presentation accompanying this webcast is available on the investor section of our website, along with the press release and quarterly report on Form 10-2 for The second quarter ended June 30, 2026. On the call today are Renee Gallo, President and Chief Executive Officer, Sam Pierce, Chief Commercial Officer, Robby Annone, Global Head of R&D and Chief Medical Officer, and Phil Johnson, Chief Financial Officer.

On slide two, I'd like to remind you that today's webcast includes forward-looking statements such as those related to our future financial and operating results, growth potential and anticipated development, regulatory and commercial milestones, The Office of Policy and Policy and Policy and Policy, provided on the Jazz Phaμ an additional month to date, as the Office of Policy and Policy and Policy for the Department of Security. We undertake no duty or obligation to update our forward-looking statements. As noted on slide three, we will discuss non-GAAP financial measures on this webcast. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release and the slide presentation available on the Investor section of our website.

Now I'd like to turn the call over to Renee.

Thanks, John. Good afternoon, everyone, and thank you for joining today's conference call. We delivered another outstanding quarter, generating record revenue of $1.2 billion, representing 16 percent year-over-year growth. The momentum we've built in the first half of the year provides us with confidence to raise our full-year revenue guidance. Our results reflect an intense focus on aligned execution across our diversified portfolio, sustained demand of our commercial We will go over to management, and I will now turn the call to light on the other. And I will share with you, the the key things you want to do to launch this next year. And the new feature of the SANI DataMap, the cost of this is financial service, which is a health issue that requires a risk of getting forward.

And I will invite you to introduce the panelists to our panelists and to the panelists. I will now turn the call over to a wonderful day to see how we do the Jazz Pharmaceuticals' plans to help them get their plans, and to help them get their plans, and to help them get their plans. And that is, I will turn the call over to a new year of the Jazz Pharmaceuticals' plans, and to help them get their plans. Thank you. Position us to sustain our momentum while delivering meaningful benefits for patients and driving robust returns for our shareholders.

With that, I'll turn the call over to Sam to share more details on our commercial performance.

Thank you, Renee. Our commercial teams delivered another impressive quarter of revenue with 16% growth across the portfolio and double digit growth from each of our key promoted brands. This performance is a result of focused investment and targeted impactful execution, which is driving sustained momentum across our increasingly diversified portfolio. I will begin on slide 7 with rare sleep. Diwave's profile as the only low sodium oxabate on the market continues to resonate with physicians and patients. Diwave net product sales increased 13% to $471 million in the second quarter of 2026 compared to the second quarter of 2025. Supported by targeted healthcare provider and patient-focused digital campaigns, our field execution continues to expand the narcolepsy and idiopathic hypersomnia markets and deliver sustained new patient ads.

These efforts emphasize XyWave's differentiated low-sodium profile and the efficacy it provides by treating underlying, disrupted nighttime sleep and addressing daytime symptoms for patients living with narcolepsy and idiopathic hypersomnia.

Demand for XyWave remains robust, with approximately 525 net patient additions in the quarter. This brings our total active patients to approximately 17,125, representing more than 12% year-over-year growth. This momentum is supported by our targeted investments in high-touch patient support services, such as our Field Nurse Educator Program, which deliver differentiated support to help patients achieve optimal dosing and sustained treatment. This first-half performance underscores the durability of our sleep franchise, with limited impact from high-sodium generics. Whilst we will closely monitor second-half market dynamics, including generic availability and potential new product launches, our confidence in Zyway's foundational role is unwavering. Its clinical profile remains differentiated as the only low sodium oxfate and the only FDA approved option for IH patients.

Moving to slide eight and Epidiolex. Epidiolex delivered another outstanding quarter with net product sales growing 16% year over year to $292 million, driven primarily by robust underlying demand. This momentum is fueled by our field team's ongoing success in educating HCPs and caregivers on Epidiolex's broad spectrum efficacy and its meaningful beyond seizure benefits for new and existing patients.

Concurrently, we are actively expanding the Epidiolex franchise. While Rolb will cover our clinical expansion into new treatment-resistant seizures, I want to highlight a critical lifecycle initiative, our novel capsule formulation. Designed to unlock additional utilization within our approved indications, the capsule targets deeper penetration in certain segments of the adult patient population. By offering this convenient alternative alongside our oral solution formulation, we aim to improve accessibility and compliance for adult patients, while firmly reinforcing our long-term leadership in the anti-seizure market.

Turning to our oncology portfolio, we are extremely pleased with the ongoing launch of Zihira in BTC, as shown on slide 9. In the second quarter of 2026, Zyheera generated $15 million in net product sales. Since launching in second line BTC, we have rapidly established clinical leadership, achieving more than 50% of the addressable market share in the US. This clinical momentum is driven by deepening utilization in academic centers and expanding adoption across community settings, supported by highly consistent, positive, real-world prescriber experiences. Critically, our success in BTC serves as a powerful commercial foundation for our next major growth phase in GEA. Because there is significant direct overlap between existing BTC and GEA treating accounts, our commercial infrastructure is fully primed.

On slide 10, you can see how our launch readiness framework is designed to drive rapid uptake. Our commercial footprint is highly optimized, with over 90% target position overlap, allowing our team to rapidly generate clinician excitement and demand. And this enthusiasm is rooted in Zani Datamab's exceptional clinical data, specifically an unprecedented median overall survival exceeding two years, establishing it as the potential preferred backbone in HER2-positive GEA. To support immediate clinical adoption at launch, we've submitted this data to key oncology pathways, and we'll leverage our already established permanent J-code to minimize reimbursement barriers. Backed by our robust Jazz Cares patient support program, we are fully prepared to deliver seamless access to patients upon approval.

Turning to slide 11 and Medezo. Medezo generated $48 million in net product sales in the second quarter of 2026, representing remarkable progress since our launch in August of last year. Driven by highly coordinated disciplined execution, more than 600 patients have now been treated with Medezo through the end of the second quarter. To sustain this upward trajectory, we initiated additional non-personal promotion and peer-to-peer speaker programs in the second quarter. These initiatives are designed to educate community-based physicians and expand our reach to ensure timely referral of patients to academic centers of excellence. On the diagnostic front, while biomarker testing is already high in high-grade gliomas, we are actively working to establish reflexive testing across all gliomas.

This systematic approach is critical to ensure every H3K27M patient is identified early and referred to targeted care. To support this, updated NCCN guidelines now endorse liquid biopsy for the H3K27M biomarker. This represents a major milestone that broadens diagnostic pathways, reduces patient risk, and accelerates time to treatment.

Finally, Midezo continues to benefit from robust, highly favorable payer coverage. Combined with our dedicated patient support services, we are exceptionally well positioned to maintain this strong commercial momentum. Moving to slide 12 and Zepzelka, we are very pleased with Zepzelka's performance this quarter, achieving $106 million in net product sales, a 42% year-over-year increase. This robust growth was driven by highly positive prescriber feedback and rapid adoption in the first-line maintenance setting, which more than offset the anticipated tapering of our historical second-line business.

The strength of our MFORTE trial data clearly demonstrates that Zepzelka's greatest clinical value is in early intervention in combination with a PD-L1 inhibitor in the first-line maintenance setting, a consensus recently reinforced by its elevation to a Category 1 listing in the NCCM guidelines. Because metastatic small-cell lung cancer progresses so rapidly, reaching patients earlier in their journey is critical. Later, Rob will provide an update on the second line indication. Overall, we are very pleased with the commercial performance across our portfolio in the second quarter, and we remain focused on sustaining this momentum throughout the remainder of the year.

With that, I'll now turn the call over to Rob to provide an update on our pipeline. Rob?

Thanks, Sam. I'll start on slide 14. This is a very exciting time at Jazz Pharmaceuticals As given in part by the August 25th Bidufa for Xanadetamab. The Phase 3 Horizon GEA-01 trial results were recently published in the New England Journal of Medicine, further characterizing the efficacy and safety profile of Xanadetamab in combination with chemotherapy, with and without the PD-1 inhibitor Tizalizumab. The publication in the New England Journal of Medicine underscores the clinical significance of these results, and we believe will support awareness and adoption of Xanodatamab among oncologists treating GEA patients.

We also presented subgroup data at ASCO, confirming that the XANI and TISLI combination delivers a consistent survival benefit, irrespective of PD-L1 tumor expression. A 26.4-month median overall survival was observed with the xanadetamab plus tizolizumab arm, which was more than seven months longer than the control arm with trastuzumab. The benefit was seen for all HER2-positive patients, irrespective of tumor PD-L1 status, and represents a remarkable advance for this patient population. Danidatumab plus chemotherapy showed a clinically meaningful survival benefit with a median OS of more than two years and a strong trend towards statistical significance at the time of the first interim OS analysis. We look forward to the upcoming top-line results from the second interim OS analysis of this double arm, which are expected in 3Q26.

In addition, we have submitted the New England Journal of Medicine manuscript for potential inclusion in the NCCN guidelines. Our belief in XANA data map increases as it was recently granted breakthrough therapy designation for adults with previously treated, locally advanced, unresectable, or metastatic HER2-positive Colorectal cancer We look forward to sharing more on our development plans for colorectal cancer in the near term Turning to slide 15 our R programs remain focused on building the next generation of growth drivers through internal innovation and external partnerships We are leveraging our deep expertise in rare epilepsies to broaden our pipeline and extend the potential benefits of Epidiolex Also known as cannabidiol to more patients with treatment resistant seizures We are initiating three new clinical trials including a phase four trial in adults with LGS a phase three trial assessing the anti efficacy in a broad group of developmental and epileptic encephalopathies and a seamless phase two three trial that will explore the We'll be right back.

We will now turn the call over to management for the FDF and TSC to broaden utilization of epithiolex in currently approved indications of LGS, DS, and TSC to improve flexibility and provide a new administration option for patients.

Moving to oncology and Zipselka, based on the results of the LAGUN trial and in alignment with FDA, in 3Q26, we will submit for FDA's review and subsequent action a labeling supplement to remove the second-line indication. The first-line maintenance indication will not be affected.

Lastly, on MODESO, our Phase III action trial is progressing. Based on the latest estimate of event accrual, we now anticipate that the overall survival interim analysis will be in the first half of 2027. This trial is designed to confirm the benefit of MODESO and support regulatory approval as frontline therapy directly following radiation. We are making meaningful progress across our pipeline and in-house R&D efforts, and we look forward to sharing more updates as our programs advance. Now I will turn the call over to Phil for a financial update. Phil?

Thanks, Rob. Before diving into the financials for the quarter, I'd like to underscore our consistent progress delivering on our rare disease strategy. Our commercial organization is firing on all cylinders, and we're making targeted investments to continue our momentum. Our R&D organization is working with urgency to generate practice-changing clinical data, highlighted by the Nijin publication of the Zani first-line GEA results, and speed new medicines to market while also We are also expanding indications for our existing medicines to benefit even more patients. And we are deploying capital in a disciplined manner to enhance our growth prospects, most recently with the upsellery deal.

Turning to the financial results for the quarter, I will start with high-level comments on our non-GAAP adjusted P&L as shown on slide 17. Please note that our full financial results are available in today's press release and 10Q. The outstanding execution of our field-based teams was reflected in record quarterly revenue of $1.21 billion, an increase of 16% over the second quarter of 2025, driven by 32% growth in our oncology portfolio, 13% growth in Zywave, and 16% growth in Epidiolex. Moving down the P&L, our non-GAAP adjusted gross margin declined slightly year on year due to higher sales of Zepselka and Medeso, which carry third-party royalties.

Non-GAAP adjusted SG&A and R&D expenses both grew 11%, with the increase in SG&A driven by higher expenses for Medeso and Zahira Firstline GEA, and to a lesser extent by investments in key commercial capabilities and digital and AI. While the increase in R&D was driven by higher expenses related to clinical trial costs, primarily related to Zany Datamab. Our non-GAAP adjusted effective tax rate this quarter was moderately higher than our full year 2026 guidance due to shifts in the expected geographic mix of income and expenses.

While our shares outstanding for the quarter reflect the accounting effect of our higher share price on our convertible notes and employee stock plans. At the bottom line, we posted very robust non-GAAP adjusted EPS of $5.71, which included IPR&D charges totaling $0.94. Beyond the income statement, I'd highlight that we generated operating cash flow of $824 million in the first half of the year, and during the second quarter, we paid off our 2026 convertible notes. With our strong financial position, we're able to continue to invest in our currently marketed products and our existing pipeline, as well as in corporate development.

Turning to slide 18 and our 2026 financial guidance, I'll focus my comments on those guidance elements that have changed since our last earnings call. We now expect total revenues in the range of $4.60 to $4.75 billion. This significant upward revision is largely driven by the outstanding execution of our XIWAVE field teams, driving home the unique benefits XIWAVE offers as the only low-sodium oxabate.

To date, uptake of high-sodium generics has been quite limited, and we continue to post strong net patient ads. We now anticipate double-digit growth for ZyWave in 2026 and rare sleep revenue of between $2.025 and $2.125 billion. Strong first-half results of our rare oncology and epilepsy portfolio further support our revised total revenue guidance range. On the expense side, we've modestly increased our SG&A expense guidance. This reflects deliberate strategic investments to build upon momentum in Zywave and Epidiolex, as well as to drive implementation of our rare disease strategy and our corporate development efforts.

Finally, our updated share count guidance is 69 to 70 million shares, reflecting the increase in our stock price since our last earnings call and its accounting effect on our convertible notes and employee stock compensation plans. I will now turn the call back to Renee for closing remarks.

Thank you, Phil. I'll conclude our prepared remarks on slide 20. Our second quarter results demonstrated the strength and continued diversification of our product portfolio, delivering record quarterly revenue, including a 32% increase from our oncology products compared to 2Q25, and consistent execution across our commercial and R&D pipeline. Importantly, we enter the second half of the year with significant momentum, highlighted by the anticipated Vani Datamab approval and launch in GEA and multiple upcoming clinical readouts. Building on our proven scientific capabilities and strong financial position, we are making a meaningful impact for patients. Over the past 12 months, we have embarked on I am incredibly proud of the execution by the entire Jazz team during this time and deeply grateful for the trust you have placed in our shared vision.

That concludes our prepared remarks. I would now like to turn the call over to the operators to open the line for Q&A.

Hi there, Mark. This is Sam. Yes, thanks for the question. Yeah, very pleased with the continued momentum that we've seen for Epidiolex, 16% revenue growth, taking up to $292 million for the quarter. This is 12% volume growth, which again just reflects really good, strong demand in both the pediatric and the adult settings, reinforcing our position as the number one branded anti-seizure medication in refractory epilepsy. I think some of this growth is coming from, continues to come from our focus on the long-term care setting. As you know, we've generated some good data there. Beyond seizure benefits really resonate with adults, and we can continue to see good headroom for growth, actually, in that segment as well.

There were no really significant, unusual inventory movements, but I'll hand over to Phil if he wants to comment further on that topic.

Yeah, thanks, Sam. Just to note, Mark, ex-US, you may recall that in the second quarter last year, we had talked about some one-time pricing adjustments that were made in a couple of the ex-US markets that did depress second quarter 2025 revenue Thank you.

Good question, Jeff. So we've been productively engaged with the FDA, and it does feel like we're in the home stretch. We're highly confident in the approval, I would still say on or before the PDUFA date, and we are certainly ready to launch. On your second question around the second interim for the doublet, certainly we had a great result at the very first interim, and certainly we have more power this next term. So looking forward to those results in 3-2 of this year.

Yeah, appreciate the question. Definitely extremely pleased with the performance of our field teams driving ZyWave. It really is a pretty astounding and amazing story, and really based in the unique benefits that ZyWave offers as the only low psyllium oxidate. You know, we've been seeing this resonate with physicians as well as patients. I think we've continued to see that during this year, probably leading to even slower uptake of generics than we might have originally anticipated, which is leading to some of the raise we have for the guidance this year. I would say that continues to put us in a really strong position as we think about the go forward discussions that we might have with payers as well, given that the market continues to highly value the unique position that only Zywave occupies.

So not ready to sort of give specific guidance on 27 yet. We'll do that when we get to the fourth quarter 26 call early next year. But the momentum we've got gives us increasing confidence in the position that Zywave will have in this market on a go forward basis.

Yes, thanks for the question, Ash. Yes, we do believe that for the GEA launch, obviously having a strong foundation of support from those academic centers is key. And of course, the data really has been well received by those physicians following the publication in the New England Journal of Medicine. And they're eagerly anticipating the launch. But what will be very important with this launch and something we really appreciate is how important it will be for the community physicians to really understand the data and to quickly adopt Zaheer as the new standard of care in GEA. This is something that we're quite well prepared for because it pretty much mirrors the situation with Zepselka. So we have a team already out there who are very well positioned to very strong overlap, as you know, between Zepselka and Zahira.

So they're well positioned to communicate the benefits of Zahira to community physicians, and we anticipate good, strong uptake there for all the reasons that we've talked about previously. The overlap, the fact that we have the permanent J code already established, and we have those relationships already in place.

I'll take that one. Yeah, I mean, we're very, very pleased, obviously, since we launched Zepzelka in the first line maintenance segment in October last year. We've seen really strong adoption of Zepzelka with those patients, and that's really what's driven the growth that we've seen over the last few quarters, 42% growth this quarter, taking us to $106 million.

And that growth is really all being down to our success in that first-line segment. We estimate now that between 30% to 40% of our overall U. S. sales are coming from that first-line maintenance segment, and of course, that's growing. And that is reinforced by the recent NCCN category listing elevated to Category 1 as a preferred regimen and first-line maintenance in combination with Cicentric. So whilst we have been seeing a gradual decline in that second line business as a result of competition, but also as patients get initiated onto Zepvelka in the frontline segment, they're not going to get retreated in that second line segment. We can expect the second line business to erode. That's what we were anticipating.

And of course, with the announcement today, we may expect that to accelerate. But, of course, all of that is factored into the guidance that we've provided for this year.

Rob, would you like to add anything from your perspective on that? Yeah, I mean, I would just say that we designed the Inforte trial because we really felt that it was important to preempt progression in this pretty aggressive disease and had a strong hypothesis that Cedzelka would synergize with a PD-L1 inhibitor like a t-zolizumab, and that is what we observed in Inforte. So we think frontline maintenance is the best place to use Zipselka for patients to get the best benefit and the longest treatment duration. We think there is a synergy with PD-L1 antagonists, and there was important data published at ASCO showing just that, looking at the impact of tumor-associated macrophages of Zipselka and explaining the potential synergy with PD-L1 agent.

And so we do think frontline is the best place to use of SELCA.

Hi, yes, thanks for the question. Yes, of course, we're very pleased with the durability that we've seen for Zywave. You know, we did, as you mentioned, we had really good solid patient ads this quarter, 200 for narcolepsy, 325 for idiopathic hypersomnia, in total 525. Net patient ads, actually the highest number of ads that we've had for a year. So very happy to see that continued momentum. Obviously, the brand is proving itself to be very durable in the face of multi-source generics.

You know, that's perhaps not surprising given the differentiation factors for Xywave haven't changed with the availability of multi-source generics. You know, we're still the only low-sodium oxidase on the market, the only product approved for IH. Obviously, as we look ahead, we are anticipating the launch of the orexins. And I'll maybe get Rob to comment a little bit on how he's seeing the potential combinability of orexins with XyWave. Rob?

Yeah, thanks, Sam. You know, across the hypersomnies, NT1, NT2-IH, the root cause really is disrupted nighttime sleep. And XyWave is the only approach to address the disrupted nighttime sleep. And so we think it's a cornerstone of therapy there. It's been the case that patients will also use daytime stimulating agents, and we think that norexin offers another opportunity to complement the potential benefit of Oxivates and specifically Cywaf.

Well, I'm going to jump in a bit on the trial. Yeah, so the trial is positioned in patients who have been treated with Nher2, and the current treatment paradigm that's typically third line plus patients. I'll remind you that we have data showing that Sanadatumab, given its unique mechanism of action, is active even in patients who've progressed on Nher2. And that comes from monotherapy data. It comes from combination data with standard of care, say in the HER2 positive, ER positive population that we published, and also with novel agents like the ALX agent. We think this is roughly 150,000 patients annually, and we also feel that it's a significant unmet need as an HER2 progressively moves to the front line.

The Xanadetamab would be, I think, unique in having data demonstrating its activity versus standard of care in patients who've progressed on an HER2 regardless of the line of therapy. So we're eager to see those results. We've said in the past that we expect to see the trial complete enrollment mid-2027, and we could see results depending on how the events progressed late 2027 or early 2028.

Yeah, thanks. I'll start and then also welcome comments from Sam and Rob in terms of both the broader commercial opportunity and some of what we are investing in on the clinical side. But if you step back and think about Epidiolex as a growth driver for the company, with the visibility of long durability into the very late 2030s now with this franchise, we believe we have multiple opportunities to invest. We talked today about multiple clinical programs underway, and we also believe having the capsule formulation allows us greater potential penetration into the adult market for certain patients who are more suitable for the capsule formulation. And if we step back and think about the impact that this business development transaction of bringing Epidiolex into the company has had for us, it's created now a major growth driver.

We paid a little over $7 billion for what is a franchise that is growing nicely over a billion dollars a year with the opportunity to grow in multiple formulations through clinical data and also internationally. Unfortunately, it's a really nice business for us to be in and also continue to build around when we think about future business development transactions.

Sam, do you want to comment further on the capsule? Yes, happy to. Yeah, we're very, very excited about the potential for Epidiolex to continue its strong momentum into the future. We have seen and we continue to execute on our strategy to grow Epidiolex in the adult segment. We continue to see growth in keeping patients on treatment for longer, and that persistency is really very material in terms of the long-term outlook. And we also identify an opportunity for patients to restart Epidiolex who may be of previously discontinued treatment. And when you look at the capsule formulation, the capsule formulation is going to enable us to do all of those things even better, particularly for those adolescent and adult patients where the oral liquid solution is a less convenient option for them.

So we believe the capsule will enable us to capture naive patients, improve persistency in existing patients, and encourage restarts for patients that maybe started on the oral solid dose, on the liquid, and it wasn't the best treatment for them. So we do believe when you take all of those together, this is a material incremental opportunity that will drive more patients benefiting from Epidiolex.

And maybe just to hit your IP question right before Rob jumps in, the capsule launch does not have any impact on IP. It does not have any impact on our ANDA agreements that extend the durability, as I mentioned, out to the 2030s, the very late 2030s. Our patent estate contains method of use patents that are relevant to all approved indications, and that's relevant to both the existing oral solution as well as the new capsule formulation.

So, Rob, do you want to cover now the clinical program? Yeah, so we're excited to be initiating a number of new clinical trials with Epidiolex. You know, we're convinced of its broad activity across different seizure types based on prior data we have for the current indications and the EAP. And so, as you know, about a year ago, we initiated a phase two trial in focal onset seizure. We just announced a trial we initiated in juvenile myoclonic epilepsy. That will be with the capsule formulation, and that's a phase two, three seamless design, so potentially pivotal. We also are initiating a trial in a broad set of DEs that could lead to a broader label there. That would be pivotal.

And doing some more work in adult LDS patients to really try to better characterize its efficacy there and support its use from adult prescribers. So confident in the activity that Epidiolex has, its ability to combine, and as has already been said, because of the longevity that we're initiating new trials in the space. But then since I have the mic, I just want to make sure my comments earlier on breast cancer for Zihara were understood. 150,000 really represents the pool of metastatic patients globally. So obviously it's a subset of that who would have progressed and still are eligible for treatment after and her too.

I can certainly start and then maybe hand over to Rob. Yeah, I mean, the differentiation for XyWave is twofold. And perhaps one of the most kind of important things about XyWave is the low sodium. And of course, that's going to be a component of its differentiation that will go beyond just another product having an IH indication. And this is a message that really does resonate with prescribers. We know that patients who are diagnosed with IH or narcolepsy, the majority of them do have a cardiometabolic or cardiovascular comorbidity. And so increasingly, I think, physicians and patients recognize the importance of having a low sodium option. And that differentiation is obviously pretty durable. So in relation to the erection question, maybe I'll hand that over to Rob.

Thanks, Sam. I was just going to add, again, that we are different. Sidewave is differentiated on the basis of low sodium, and while it's well understood that not only narcolepsy, but IH patients have a significant risk of negative cardiometabolic outcomes, We also demonstrated that in the Xylo study that after initiation of high sodium oxabate, you see a change in blood pressure, which is clinically meaningful. And so patients benefiting from Xywave now, I think that will be pretty sticky.

Did I miss another aspect of the question on narcolepsy that you wanted me to address, Sam?

I think there was a question just around the competition versus the longer availability of orexins Yeah I mean again I think I answered this earlier whether it be IH or narcolepsy the root cause of the daytime sleepiness and symptoms such as cataplexy have to do with disrupted nighttime sleep and only oxabate And by the way, being really the safest, Oxovate, you know, can address that root cause. And so we continue to think that that will have an important role in treating patients, even if they would additionally benefit from daytime weight-promoting agents.

And just to build one last point here, with respect to the IH market, we are still very early in our overall penetration. We think there's probably 37,000-plus patients diagnosed and seeking treatment for IH, and while we've made significant progress in headway, we do believe there's a lot of room still to grow here, and we believe that ZyWave, as we've seen with narcolepsy, including the patient support services supporting the overall journey that patients go through with a new diagnosis of idiopathic hypersomnia, We do believe that Zyway will continue to compete well in this market.

Sure. So we have the ongoing basket trial, which is the 206 study, and in that trial, we continue to enroll patients with second-line colorectal cancer and non-small cell lung cancer. We had previously published on colorectal cancer, and those were some of the data that we brought to FDA, including an addition data from the emerging 206 trial that led to the breakthrough designation for colorectal cancer. So we'll continue to generate data in both of those indications through that study, and we'll work with FDA now that we have BTD to identify the path forward ultimately for approval in colorectal cancer. You know, more broadly, we're very excited about the potential of Xana Datamad. We have the ongoing frontline BTC trial that we're optimistic about.

As you know, we're about to launch in GEA. We're contemplating other areas in gastric cancer, such as early gastric cancer where there's no approved HER2 therapy. Of course, we have the ongoing late-stage metastatic breast cancer trial, as well as other Phase II trials looking to determine how else we might use Xanian combinations, sometimes novel combinations, in the breast cancer setting, as well as the new indications such as CRC and non-small cell lung cancer, as you mentioned. So, overall, we do think this is a pipeline and a product, and we're pursuing every opportunity to its fullest.

I can start on NCCN. We've been providing NCCN all the data we have as soon as we have it. We shared the data that went into the abstract, and then we immediately shared the New England Journal publication. Obviously, we don't control their timelines, but we do think they have everything they need to adopt that into the guidelines, potentially even before approval, but obviously that's up to them.

Yeah, and so just I'll follow up with your question in relation to our kind of readiness to launch. I mean, we are ready to launch in GEA. You know, we sized our team specifically with a GEA launch in mind and made some investments to ensure that, you know, we can cover all of the customer groups that we want to cover very rapidly at launch. You know, BTC will serve us as a powerful foundation for the next major growth phase in GEA.

We have a number of features around our presence in BTC that make us very confident that we will be able to launch successfully and rapidly. We have more than 90% physician overlap between GEA treating centers. We obviously have access already established with the permanent J code already active from the BTC approval. We've submitted the data to Oncology Pathways, and we have onboarded a team of clinical nurse educators who are ready to support smooth, efficient access and patient onboarding, really leveraging our Jazz Cares program. So we are ready, and we think our readiness combined with the data, the compelling nature of the data, which you're all familiar with by now, means that we should see really very rapid uptake, and we're committed to ensuring that patients who need this product can get it as soon as possible.

On the second part of the question, yes, we're on track to complete enrollment by midyear 2027. When we have results will depend on the events, but we haven't changed our guidance on that for end of 2027, 2028. In terms of the design of the trial, most of the data with other HER2 agents were generated before the availability of an HER2. So that's really the The main motivation for this trial is it's unclear what to use once patients have progressed on and heard to. The trial is set up to be a third-line plus trial. It's a global trial, so in some places that will mean that patients may have gotten ducatinib previously, but in some parts of the world, such as South Korea, ducatinib is not commonly used.

And so it will be a trial where you'd expect a third, fourth, or even possibly a fifth line patient. While that's a poor prognosis group, we have prior data suggesting that Xana Datamat can be active in that setting. And again, this is a head-to-head against terceptin, so we continue to be confident in Xana's ability to beat what would be the standard of care in certain Thank you.

Phil? Yeah, this is Phil. Thanks for the question. Maybe I'll take the first part and then turn it over to Sam for color behind some of the additional investments to drive even further momentum and revenue growth for XyWave and Epidiolex. So the revised guidance really comes down to extremely strong execution in the field that's led to this unique benefit that Zywave has resonating with physicians and patients, which we believe is what's likely leading to the very slow uptake that we're seeing of generic high sodium oxibates. We had said all along that we didn't expect really much of any impact in the first half of the year, and that, in fact, has played out as we had expected.

However, based on the pace of introduction of the high sodium generics, we're now expecting a much more muted impact in the back half of the year as well that is behind the guidance raise for XiWave, where before we had expected the product to be flat to up mid-single digits this year, and now we're expecting double-digit growth for the full year. So really pleased with the momentum that we have and look for that to continue.

Sam? Yeah, and in terms of the investments that we're making, obviously, given the strong resilience of XyWave and Momentum, we are continuing to invest in some of the media spend that has been particularly effective in ensuring that patients, diagnosed patients, get treated with XyWave, as well as some investments, continued investment in the patient support program. For Epidiolex, we have continued to invest and upgraded our investment in ensuring that we can fully penetrate the LTC adult segment, where we've started to see some good inroads. And also, we do see an opportunity to drive persistence, and we have invested to expand our Jazz Cares program so that more patients can get enrolled onto the Jazz Cares program.

We know those patients generally do better on treatment. And in addition, of course, we're starting to prepare for the oral solid dose launch as well. So that's the nature of some of the additional investments that are outlined in the guidance.

Yeah, this is Renee. Thanks for the question. So we won't comment on specific deals for obvious reasons, but I would say we do remain highly engaged on the BD front. I'll remind you that we hired a new CBO earlier this year. to drive those efforts, and we do continue to expect to announce one or more deals still in 2026. In terms of the areas that we're interested in, we really do focus on where we believe there's a significant unmet need and where we believe we can have a meaningful impact with our unique either expertise, global footprint, or current other operations that we have underway. We generally will look for an efficiency of commercial call point, one where the support services that we do offer to our patients can also be relevant and valued.

We are focused on strengthening our current areas of rare epilepsy, rare sleep, rare oncology. We think there's a lot of substrate there, but we are also looking into other areas of rare disease, and we'll delay on actually providing much commentary there because there are so many different areas that we could go into that I wouldn't want to be too specific there in terms of inadvertently commenting on specific deals we might be interested in. In terms of the stage, we were really excited to announce the Abcelera deal this last quarter. That is a preclinical collaboration looking at next gen T cell engagers, so very early in our pipeline, but it directly aligns with our overall rare disease strategy, really expanding our focus on GI cancers.

We are also, though, looking at later pipeline deals as well as commercial and near commercial transactions. It really depends on the specific asset and the type of deal that we are interested in. Importantly, we have a strong track record of doing deals that have generated meaningful value. I mentioned Epidiolex with GW earlier. Last year, we did the Medeso Chimerics transaction. That was near commercial. And then we talked about quite a bit on this call about Zannie that also came into our business via business development, which we're incredibly pleased by. And I'll just close with a reminder that we're in an incredibly strong financial position to be able to execute on BD. We generated $824 million in cash flow in the first half of this year, $2.2 billion of cash on the balance sheet.

So, supports our ability to execute NBD in addition to the investments that we've talked about throughout the call today behind our commercial brands as well as our pipeline.

Thank you.

Great. Thank you, operator. Well, I'd like to close today's call by thanking all of our employees, as well as our partners and stakeholders for their continued confidence and support. We look forward to sharing additional updates on the potential approval of ZANI Datamab and GEA, as well as other progress in our business.

Looking forward to sharing those updates with you over the remainder of the year. Thank you for joining us today, and we can close the call.