Jazz Pharmaceuticals Q1 2026 Earnings Call: Complete Transcript

On Tuesday, Jazz Pharmaceuticals (NASDAQ:JAZZ) discussed first-quarter financial results during its earnings call. The full transcript is provided below. Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more. Access the full call at https://edge.media-server.com/mmc/p/7akieuf3 Summary Jazz Pharmaceuticals reported record first-quarter revenue of $1.07 billion, driven by 45% growth in its oncology portfolio. The company anticipates strong future growth with the potential approval of zanadatamab, supported by promising clinical trial data. Zebselka sales increased by 60% due to strong uptake post-FDA approval in combination with Tecentriq. Modezo achieved $41 million in net sales, reflecting high unmet needs and strong market entry. The company reaffirmed its 2026 revenue guidance of $4.25 to $4.5 billion, considering increased competition in the sleep business. Significant R&D efforts continue with multiple trials in progress, including those for zanadatamab in breast cancer and other indications. The balance sheet remains strong with $2.9 billion in cash and investments, providing flexibility for investments in R&D and potential acquisitions. Epidiolex posted 15% growth, with strategic focus on expanding into adult and long-term care markets. Management emphasized continued focus on rare diseases, with expectations for business development deals in 2026. Full Transcript OPERATOR From an established permanent J code through its FDA approval in second line HER2 positive BTC, which we expect will simplify reimbursement in GEA and reduce the administrative burden for providers. In addition, the compelling outcomes from the Horizon GEA trial supports our expectations for favourable payer access. Finally, our comprehensive Jazcare support services together with Jazz Pharmaceuticals's established availability across customers preferred distribution channels position us to enable seamless patient access at Launch. Turning to Slide 11 and Medevo, Medezo generated $41 million in net product sales in the first quarter of 2026. This strong early performance following its launch in August 2025 reflects the significant unmet need in H3K27M mutant diffuse midline glioma, high awareness driven by advocacy groups and the value physicians see for patients. Approximately 500 patients have been treated with Medezo since launch. Through the end of the first quarter our highly experienced neuro oncology field teams, including medical and Access colleagues continue to support the launch. The teams remain focused on expanding reach in community settings whilst maintaining a well supported presence in academic centres of excellence. Robust patient centric support services and payer coverage continue to underpin launch momentum and support appropriate access for patients. Moving to slide 12 and Zebselka in the first quarter of 2026 Zebselka net product sales increased 60% to $101 million compared to the same period in 2025. Growth in the first quarter was primarily driven by strong uptake in the frontline maintenance setting following FDA approval of Zebselka in combination with Tecentriq in October of last year. Given the strength of the IMforte clinical data and the opportunity to improve both progression free survival and overall survival for patients with extensive stage small cell lung cancer, healthcare providers are rapidly adopting the Zebselka combination in the first line maintenance setting. As a result, this new indication is driving the product's strong performance. Our commercial initiatives will continue to be focused on first line maintenance reflecting our ongoing commitment to this priority for the rest of 2026. First line maintenance adoption is expected to grow with second line use decreasing due to competition and fewer Zebselka and naive patients available for treatment. Overall, we are satisfied with the impressive commercial performance achieved across our portfolio in the first quarter and remain focused on maintaining this momentum throughout the year. With that, I'll now turn the call over to Rob to provide an update on our pipeline. Rob Rob thanks Sam. I'll start on slide 14. This is an exciting time at JAS. In addition to our outstanding commercial execution, we are also preparing to bring xana Datamab the HER2 positive first line metastatic GEA patients. The data from the Horizon GEA trial definitively demonstrated that xanadatamab offers improved outcomes on all efficacy measures compared to trastuzumab and should be the new HER2 targeted agent of choice. The data also showed tizalizumab further improved survival outcomes in both PD L1 positive and PD L1 negative patients. The benefit, regardless of PD L1 status, may be driven by xanadatamab's unique mechanism of action known as biparotopic binding. This enables xanadatamab to cross link neighboring HER2 receptors, leading to receptor clustering which blocks HER2 growth signaling and also triggers the complement cascade. Xanadatamab's ability to uniquely and broadly activate the innate immune system may in part explain the additional efficacy observed when tizalizumab was added to xanadatamab even in PD L1 negative tumors. The triplet arm of xanadatamab, tizalizumab and chemotherapy demonstrated improved overall survival with a remarkable median OS of 26.4 months, representing a meaningful improvement of more than 6 months median OS compared to prior studies in HER2 positive patients who have a poor prognosis in the metastatic setting. Among patients who had an objective response, the median duration of response was 20.7 months. Again, this benefit was observed irrespective of tumor PD L1 status. To put this into context, in the Keynote 811 trial, the duration of response for trastuzumab and pembrolizumab plus chemotherapy was 11.3 months. We are moving quickly to bring xanadatamab to HER2 positive first line metastatic GEA patients. Following the oral presentation at ASCO GI in January, we submitted the data for potential inclusion in NCCN guidelines. We're pleased that the manuscript has been accepted for publication by a top tier medical journal and plan to submit the peer reviewed manuscript to NCCN once it has been published. Our supplemental BLA for Xana Datamab has received priority review with a PDUFA date of August 25, 2026. We are actively engaged with the FDA in the review process and we expect potential approval and launch of zanadatamab in GEA on or before the PDUFA date. Turning to Slide 15 in our pipeline, we have multiple clinical trials across our pipeline from early stage to registrational trials. We look forward to sharing data from some of these ongoing trials at the upcoming ASCO meeting in early June with a number of presentations on leronectadin and zanadatamab. The second planned interim analysis for overall survival of the xanadatamab and chemotherapy arm of the Horizon GEA trial is still expected mid year. At the time of top line readout, this arm showed a clinically meaningful effect on overall survival with a strong trend towards statistical significance compared to the control arm. The next pivotal Phase three trial for xanadatamab is in metastatic breast cancer patients who have progressed on or are intolerant to and hurt to and trial enrollment is progressing well. We continue to expect to complete enrollment and in the EMPOWER trial in the first half of 2027 with top line data anticipated in late 2027 or early 2028. Other earlier stage trials continue to progress across new indications including a potentially registrational pan tumor basket trial and a neoadjuvant breast cancer trial. Looking ahead to later this year or early 2027, we anticipate the ongoing Phase 3 action trial will have an interim overall survival readout. This trial is designed to confirm the benefit of MODASO and support regulatory approval as frontline therapy directly following radiation instead of waiting for signs of tumor progression before treating with modaso. We are working with dedicated focus to both realize the full potential of our near term opportunities and to rapidly progress our pipeline. Our in house research and development efforts are underway and we look forward to sharing updates on those and further pipeline progress in the future. Now I will turn the call over to Phil for a financial update. Phil Phil thanks Rob. I'll start with high level comments on our non GAAP adjusted PL 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 first quarter revenue of $1.07 billion driven by 45% growth in our oncology portfolio, 18% growth in Xywav and 15% growth in Epidiolex. Strong underlying performance drove the vast majority of our revenue growth. I do want to point out two smaller items that also contributed to growth this quarter. First, we had the normal 13 shipping weeks for our US oncology products this quarter while in last year's quarter we had 12 shipping weeks. This contributed about 2 percentage points to our worldwide revenue growth rate. Second, the significant devaluation of the US dollar led foreign exchange to contribute about one and a half percentage points to our worldwide revenue growth. Moving down the P and L, our non GAAP adjusted gross margin declined slightly year on year primarily due to higher sales of products carrying royalties, namely Zevselka and Medezo. Non GAAP adjusted SGA expense decreased by about $164 million. You may recall that in last year's quarter we recognized litigation settlement expenses of $172 million. Excluding these expenses, SGA increased by $8 million driven by the inclusion of MODESO expenses. Non GAAP adjusted R and D expenses increased by $13 million primarily due to the inclusion of Medezo clinical trial expenses and higher compensation related expenses. Our non GAAP adjusted effective tax rate this quarter was slightly lower than Our full year 2026 guidance due to excess tax benefits from share based compensation, 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 post very robust non GAAP adjusted EPS of $6.34 supported by our strong start to the year. We are reaffirming our full year 2026 revenue and expense guidance including total revenue guidance of 4.25 to $4.5 billion. Total revenue guidance for 2026 includes the assumptions you see on Slide 18. As a reminder, we assume competitive dynamics in our sleep business will increase in the second half of the year, including high sodium generics gaining volume and one or more daytime weight promoting agents potentially entering the narcolepsy market. We also expect to see a decline of Xyrem and high sodium authorized generic revenues as generic high sodium oxybates build their volumes over the course of 2026. And as Sam mentioned earlier, we expect a decline in second line use of Zebselka. Our Q1 performance and focus on disciplined capital allocation position us well to achieve our 2026 guidance. Moving to Slide 19, our balance sheet remains strong. We continue to generate significant cash from our business, recording $408 million of cash from operations in the first quarter of the year and we ended the first quarter with 2.9 billion in cash and investments. Our overall financial position and robust operating cash flow provide significant flexibility to invest in value driving commercial and R and D programs as well as in promising corporate development opportunities to support our rare disease strategy. I will now turn the call back to Renee for closing remarks. Renee Thank you, Phil. I'll conclude our prepared remarks on Slide 21. The first quarter of 2026 builds on the successes we achieved in 2025. Our focused commercial execution led to more than 19% growth in the first quarter and based on these results we are on track to achieve our 2026 financial guidance. We look forward to several upcoming catalysts including the second interim analysis of overall survival from the Horizon GEA trial. Mid year top line readout for overall survival for the Confirmatory Action trial from ADASO is expected at the end of this year or early next year and the top line readout from the trial evaluating Xanidatamab in late stage breast cancer post in HER2 treatment is is expected in late 27 or early 2028. We continue to build upon our proven scientific expertise and capabilities to make a meaningful impact for patients supported by our strong financial position. You should expect to see us invest in our commercial brands and pipeline and business development to broaden our portfolio in key strategic focus areas of sleep, epilepsy and oncology in addition to other areas of rare disease. I'd like to thank all our JAS colleagues for their efforts and dedication to making a difference in the patients lives that led to an exceptional first quarter. We are relentlessly focused on continuing to execute and deliver life changing medicines to patients. That concludes our prepared remarks. I'd now like to turn the call over to the operator to open the line for Q and A. OPERATOR Thank you. As a reminder, if you would like to ask a question, please press star 11 on your telephone. We also ask that you wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q and A roster. Our first question today will be coming from the line of Jess SE of JP Morgan. Please go ahead. Jess SE (Equity Analyst) Hey guys, good afternoon. Thanks for taking my question. Question on xanadatamab for Breast cancer so if we assume xanadatamab beats trastuzumab in breast cancer and gets approved one day for use in the post and HER two setting, how do you expect physicians to make decisions about how to sequence agents in the context of a lack of data for other products code and her too, among other things. Thank you. Robbie Noan I'm happy to address that. Jess, this is Robbie Noan. We became very interested in this space based on good advice from many key experts in the field. And the fundamental issue is that once in HER two moves to frontline, there's very little data about which her two agents select a subsequent therapy. So the trial that we're running 303 will be the first time that we definitively, in a randomized setting evaluate xanadatamab versus what would be considered a standard of care. So we expect to be out ahead with important data that will inform decisions about whether to use xanadatamab or other HER2 agents in that space. OPERATOR Thank you. One Moment for the next question. And the next question is coming from the line of Joseph Thom of TD Cowan. Your line is open. Joseph Thom (Equity Analyst) Hi there. Good afternoon. Congrats on the quarter and thank you for taking my question. Maybe one on Modazo. Do you have any updated thoughts on sort of the size of this patient population? I think historically it was thought that it was maybe 2 or 3,000, but it sounds like you're already hitting 500 patients. So any thoughts on that total opportunity? Just given the strength of that launch and maybe a follow up if I can, on M&A kind of. What's your latest thinking in terms of where you'd like to go? Obviously we've seen a lot of activity in the past few weeks in different areas. Kind of what's the sweet spot in terms of size and area of focus for. For Jazz Pharmaceuticals. Thank you. Sam Yes, hi, Sam here. I'm happy to take the question on mode. So to start with, yeah, we're extremely pleased with the launch so far. $41 million in Q1 really gives us a lot of confidence around achieving that $500 million peak opportunity in the U.S. and as you mentioned, we've had 500 patients treated since launch. And I think that just reflects the very high unmet need that we see in this space. Overall survival from diagnosis is just one year. So this product has had a meaningful impact and it's supported by high awareness from physicians and obviously very strong patient advocacy support as well. In terms of the size of the patient population, I think our best estimates are aligned to what you mentioned there. And over time, of course, we'll continue to evaluate that. But we do see potential upsides in duration of treatment as well as the size of the population. What we've seen so far is that patients are staying on treatment for longer than we initially anticipated. We'll have to wait for this cohort of patients to really mature before we get a really good handle on whether the duration of treatment exceeds that that we saw in the trial, which was around about 10 months, but extremely happy with the start. I think our teams have done an excellent job really executing this launch well in such an important area of medical need. Renee And Jo, this is Renee. I'll jump in on business development. So we are highly engaged on the BD front and I do expect us to have deals announced over the course of this year. We do have a clear strategy that is focused on expanding our presence in rare disease in particular, where we believe there's a significant unmet need. So strengthening our current areas of epilepsy sleep and rare oncology. Also expanding into new areas of rare disease, areas where we think we can leverage our capabilities and our footprint to continue to scale our business while driving further growth and profitability. In terms of the deal types, we it really depends on the asset and the transaction at hand, but we are looking at licensing structured deals, also outright M and A. I think the key here to being successful in BD is identifying value or risk that others don't see and then staying myopically focused on execution as we did with the Chimerix launch, the Chimerix acquisition and subsequent medasso launch. And we have very strong momentum now with the new CBO Chief Business Officer on board as of January 1st. Importantly, we are well positioned to execute. Phil mentioned we have a strong financial position, $2.9 billion in cash and cash equivalents on the balance sheet, strong cash flow and while M&A has picked up, we do believe there is still a lot of substrate that is actionable and well aligned with our strategic priorities. OPERATOR Thank you. One moment for the next question. Our next question will be coming from the line of Leo Temoshev of rbc. Please go ahead. Leo Temoshev (Equity Analyst) Hey guys, thanks for taking my question. I wanted to stay with you mentioned epilepsy. I just wanted to touch on that. You've been making a lot of investments in that area both with Epidiolex, the Zogenix asset. You also have JZP-047 and now you mentioned potentially looking at BD there as well. So I gu just curious how you're thinking about that area, to what extent it's a continued focus and how you think about either synergies or risk of cannibalization across many different assets there. Renee Yeah, thanks for the question. This is Renee. I would say this is definitely an area of focus for us. There continues to be significant unmet need across the epilepsy space. You see a strong amount of polypharmacy here with respect to multiple multiple medications generally on board. In particular when we're looking at serious refractory epilepsies, we think with the position that we have with Epidiolex being the number one branded product and having the very long durability out to the very late 2000s, it gives us greater opportunity to continue to build around that franchise to build scale scale. I'm thrilled to see additional opportunities for patients with the strong data that we've been seeing come out with a number of companies. Whether that's on the proof of concept side, starting to go into registrational studies or work that's happening early in pipelines. As we think about ourselves, we think there is plenty of room and need, unmet need for patients to continue to see new mechanisms explored and new options for patients. So we do think there's still plenty of substrate, a great opportunity for us as a leader in epilepsy. You will note last quarter we said we were advancing the first molecule coming out of our labs that was not just a formulation play but an innovative target novel mechanism coming out of our lab that went into patients in the epilepsy space. So we will continue to invest here and we're excited about the opportunities. OPERATOR Thank you. One moment for the next question. Our next question is coming from the line of Annabel Semia. Your line is open. Annabel Semia (Equity Analyst) Hi, thanks for taking my question. Just want to circle up on Modazo again. Obviously it's been exceedingly promising since the outset and you have the potential to move into first line treatment. I guess my question is how should we think about the potential move into first line treatment? Does this significantly expand the market? Should we think about this like we think about Zebselca moving into first line and how it significantly inflected growth? I guess I'm trying to understand the magnitude given that most patients were in first line progress to second line. Is it only about duration or is there a population opportunity there? Sam Yes. Hi Annabelle. Happy to take that. Yes. I think there's two factors when we consider the action study and what that will do for Modazo and for improving the treatment for patients. Some patients don't make it to second line, so of course there are more patients available to be treated. But having the opportunity to get mode to patients before they progress will mean that the duration of treatment should be longer if they can use it straight after radiation. So those two things I think will contribute to us achieving the $500 million peak potential, which does incorporate an assumption that we will have that first line label. Rob, anything more to add on that? Rob I mean, you covered it well. I just point out that sometimes it's hard to judge progression in these patients. And then as you point out, once it's clinically apparent, in addition to imaging, patients may rapidly progress and not benefit from second line therapy. So the opportunity to start mode so right after the radiation therapy really does potentially add a significant benefit to patients and ultimately duration of therapy. OPERATOR Thank you. One moment for the next question. And our next question is coming from the line of Mark Goodman of Lerik. Please go ahead. Mark Goodman (Equity Analyst) Can you talk about Epidiolex ex-US? I heard Phil talk about the FX impact, but those numbers couldn't have just been fx. Something is doing pretty well there. So maybe just talk about is there any particular country, was there any buy in anything unusual there? And maybe you could just comment on Rylays as well, which happened to have a really good quarter and what was happening there. Thanks. Sam Yes, thanks for the question mark. Yes, it's great to see the performance outside of the US for Epidiolex. Very strong growth indeed around about, about two thirds of that I believe was volume and there was about a third due to FX and some gross to net benefits from places like the UK with adjustments that happened there. And I think really this is just down to terrific execution by our teams. As you know, Epidiolex was launched a little bit later in Europe, so there's still quite some opportunity to continue to penetrate in the paediatric segment. But of course also in that adult segment which is a focus for both the US and the ex US business. And then your other question around Riley's. Yes, Rylays. Yeah. Yep, Rylays delivered a strong quarter, $104 million which was 10% revenue growth, but that was comparing to Quite a low Q1 25. So, you know, I think the performance that we've seen seen in this quarter is in line with the prior quarters that we've seen. Other than the Q1 which was a low point. What we've seen with Rylase is the cog impact that started in 24 has been fully realised now and our focus continues to be on making sure that patients, appropriate patients can receive Rylays, that they're sweet at the first sign of a hypersensitivity reaction and the opportunity to continue growth in Aya. But I think that $100 million per quarter for Rylays is a good kind of stable base for us currently. OPERATOR Thank you. One moment for the next question. And the next question is coming from the line of Edster Durat of Barclays. Please go ahead. Jordan Becker (Equity Analyst) Hi, this is Jordan Becker on for Etsy Dirt. Thanks for taking my question and congrats on the impressive quarter. You know, maybe just one, if we could expand on any second half dynamics for, you know, Oxybates now with a full quarter in the rearview. Maybe if you could provide some more color on any potential competitive pressure from Lumber specifically and then on that, maybe any perceived pressure to IH growth down the line if Lumriz is approved in ih. Sam Yes, I'm happy to take that question on Xywave. Yeah, we're very pleased with the continued momentum for Xywave. $408 million this quarter, 18% revenue growth and a really healthy 12% volume growth. We continue to see really good patient adds, 425 net patient adds in the quarter, most of them continuing to come from IH. 300 net patient adds for IH, which is consistent with what we've seen in prior quarters. So we finished the quarter with 16,600 active patients. And when we look ahead to the outlook for XYWE for the remainder of the year, obviously we're very pleased with the momentum that we're taking into the second quarter. We still have continued strong payer coverage, more than 90% commercial lives covered. Nothing has changed around the nature of our XYWAVE business in the first quarter of this year. And our 2026 full year guidance does include assumptions that generics will build volumes in the second half of the year as well as the potential for the entry of new weight promoting agents entering the market in the second half of the year in the NT1 narcolepsy segment. But we believe Zybove will continue to have a really important place in therapy. We've invested in some really meaningful evidence generation. Xylo and the Duet studies which show the importance of having a low sodium option. And as you mentioned, it's the only option approved for ih. And the Duet study which showed just how effective XYWAVE is as a nighttime agent. And we believe those two benefits will continue to resonate strongly with physicians and patients. OPERATOR Of course. Thank you. One moment for the next question. Our next question is coming from the line of Brian Sorkney of Beard. Please go ahead. Charlie Hey guys, thanks for taking the question. This is Charlie on for Brian. I was just wondering if you could give us a sense of the size of the opportunity for Epidiolex in the adult and long term care setting and maybe some more color on the initiatives you're taking there with the new formulation as well as would be curious to hear. Will you be sharing any data from the phase 1b and focal onset when you get that? And do you have any idea in terms of timing there as well as what your expectations are for the setting for epidiolex? Sam Thanks. I'm happy to take the first part of your question in relation to the adult segment and then I'll hand over to Rob to talk about the study. Yeah, we're very happy with the performance of epidiolex in the first quarter of this year. $250 million, 15% revenue growth and 16% volume growth. As you probably recall, Epidiolex was launched initially very much as a pediatric drug and we've seen really good penetration in that segment. A leading agent obviously for pediatric patients. One area that we do continue to see opportunities in is in that adult segment, particularly in long term care facilities. So we've made some special specific investments there with a dedicated team focusing on those facilities. And we've also invested in a diagnostic tool, REST LGS tool, because we know that adult patients with LGS often go undiagnosed. So we've supported physicians to help ensure that those patients can get a definitive diagnosis and benefit from from Epidiolex. In addition to that, one of the hallmarks of Epidiolex is the very long persistency that we see. But we do see an opportunity to drive that even further. We know that patients that are enrolled onto our Jazz Pharmaceuticals Cares program, which also gets the support of a nurse navigator, they do stay on treatment longer. So we've got a particularly focused effort now on ensuring that as many patients as possible can benefit from our jazcare suite of services. And we believe that will drive even longer durations of treatment for epidiolex. In addition to that, we're making quite significant investments in evidence generation. We have the EPICOM study in TSC and the BECOME survey which has been focused on adults, which really just underlines the benefit that epidiolex has, not just for the control of seizures, but also for controlling some of the non seizure symptoms that these patients experience as well. And that's one of the very significant differentiating benefits of epidiolex. So overall we're very encouraged by the momentum that we have with Epidiolex, but also really see a lot of long term potential to continue to grow Epidiolex into the future, particularly in that adult segment. Rob Thanks for the question on the focal onset seizure study. We're super excited about it. There's a lot of interest from epileptologists to more formally evaluate epidiolex in this setting. As you know, doctors and treaters think about epilepsy in terms of types of seizures and we have lots of data showing activity of epidiolex across really every type of seizure, with some preliminary evidence in focal onset seizures as well. This is an evidence generation study to go deeper into this particular population and we would intend to publish this as soon as we have data available to do so. We haven't given any specifics on that yet. After a little more time lapses and we get a good sense of the enrollment rate, we may be able to update further. OPERATOR Thank you. One moment for the next question. Our next question is coming from the line of David Aselam of Piper Sander. Your line is open. David Aselam (Equity Analyst) Hey, thanks. So I have a long term competitive landscape question on your oxybate business. So your competitor has Valloxybate, the sodium once nightly or potential no sodium once nightly product that's in development to the extent that reaches the market. Can you talk about how that could impact your Xywave business both in terms of narcolepsy and the IH setting? And just in general, how are you planning to respond competitively to overall a more crowded landscape? The obvious is of course with the Orexins, but also next generation oxybate products as well. Thanks. Renee Maybe I can step in on that and then I'll ask Rob to comment on how we're viewing orexins. So I would first point to the fact that Xywave has been competing for the last two years with a number of high sodium options on the market. And over that time we have not only built a strong group of patients that are relatively persistent in terms of their use of oxybate, the specific relief and flexibility that they receive from Xywave, and also being the only option available for ih, we've done a lot of work in the market in terms of disease awareness. One of the areas that we've invested quite a lot in that Sam has spoken to earlier, is the patient support services. I think that is highly differentiating for JAS in terms of the extent of our services and the way that we have deployed those. And so we will continue to ensure that the unique differentiating benefits that of XYWAVE as well as our various support services are well understood in the market. I would also note that we do, from a patent perspective, have a lot of confidence in our overall patent estate. So when you're thinking about the various programs that are out there that may be looking for a 505(b)(2) sort of path from that perspective, we do have robust patents that include many orange book listed patents out to 2033 and 37, and then an orange book listed idiopathic hypersomnia patent out to 2041. But maybe I'll also invite Rob to comment with respect to orexins coming into the market and our view there. Rob Yeah, we've been following orexins carefully and and our conclusion is that it's likely to be complementary to xiwave. As Sam mentioned, alluding to the Duet study, we have significant data showing that the root cause in hypersomnia such as narcolepsy type 1 and 2 as well as IH is really disrupted nighttime sleep and oxybates are the only therapy that can address the disrupted nighttime sleep directly. And xywave, of course, the only low sodium formulation that we believe is safest for patients who are at a high risk for cardiovascular outcomes. Certainly the orexins are showing to be potent daytime alerting agents. There's some preliminary data showing though that you can have insomnia, especially with the longer half life formulations. And the limited PSG data that are out there suggest that certainly not improving disruptive nighttime sleep and may actually on the first half of the night be impacting it negatively with the reports of insomnia. So we continue to think that this important space to follow. We have an orexin in development still, but we think ultimately this is going to be complementary to highways. OPERATOR Thank you. One moment for the next question. Our next question is coming from the line of Mohit Bansal of Wells Fargo. Please go ahead. Renee Great. Thank you very much for the question and congrats on all the progress. Just want to ask about Zabzelka IP here. I see a few new orange book listed patents here in 2025, so they go all the way to 2040. So how should we think about the life of Zabselka beyond 2029? That's the comp of matter patent at this point. Thank you. Yeah, thanks Mohit. This is Renee. So we do have a strong patent estate for Zabsalka and as you noted, we do have multiple patents that extend out to 2040. We're also pursuing multiple new patents with the patent office that would also extend out to that timeframe with additional applications, whether that be combo therapies, formulations or methods of treatment. We have also stepping back and speaking to the ANDA filers that we've disclosed, we have filed suit against all five and a filers and as a result of filing that suit, a stay of approval is in effect for up to the 30 months as is imposed by the FDA. And so while we're not going to speak broadly to active litigation, we do feel that we have a strong patent estate and as we have more clarity and information on that, we will be certain to share that. OPERATOR Thank you. One moment for the next question. Our next question is coming from the line of Jason Gerberry of Bank of America securities. Please go ahead. Jason Gerberry (Equity Analyst) Hey guys, thanks for taking my questions. Just want Phil on xywave. Apologies if I missed this, but at the beginning of the year I think you guided to flat to mid single digit growth for Xywave given a growth of nearly 20% in 1Q. Just wondering if we should be assuming that were coming in towards closer to the high end of that number or were there some one time dynamics in the 1Q number to call out and how should we think about vanadata map pricing, ous and any MFN related considerations? Phil Sure, thanks for the question. Jason on XYWAVE in the US really pleased as Sam mentioned with the great execution of our field based team in terms of underlying growth. We had volume growth of about 12% here in the first quarter. There was a bit of additional pickup coming from net price primarily gross to net favorability with both mix of business and then patients successfully transitioning more quickly than in the past back onto their insurance in that first quarter reauthorization period. So that is something that is more of a first quarter phenomenon. We wouldn't expect to see that kind of net price pickup quarter on quarter as we get into QS2 through 4. But definitely pleased with Xiwave performance in the first quarter sets us up nicely for achieving the full year guidance. I'd say that also applies to this total revenue guidance as well, not just by Wave and then for the MFN Zanny right now the MFN considerations as you know are a bit uncertain. We've got some sort of conflicting input out there. Certainly Globe and Guard are as proposed to use a basket of ex US countries to provide reference pricing for the US So we'll certainly be taking that into account as we look at the strategy for getting Zahira to patients outside of the US which is certainly a priority of ours, but one that we will need to take account of the current situation here in the US as we as we move forward. Not sure. Sam, if you'd like to add any your thoughts from a commercial perspective or Renee, more from a corporate strategic perspective. Yeah, I think you've covered it nicely, Phil. Okay, great Lisa. Next caller please. OPERATOR Thank you. And our next question will come from the line of Amy Fadia of Needham and Company. Please go ahead. Amy Fadia (Equity Analyst) Hi, good afternoon. Thanks for taking my question. I had a follow up on the comments related to the Oxybate franchise, particularly Xywav. I think at the beginning of the year you talked about anticipating the potential for some additional headwinds either on pricing side or just in terms of access with the entry of generics. Maybe if you could sort of talk about some of the dynamics around whether you're seeing any pushback on the use of xywe, particularly narcolepsy. And how do you see the utilization and narcolepsy evolve with more generics kind of on the market? And then just on the Medezo action trial, can you sort of talk about what, you know, which interim OS analysis will be done by the time you have the data readout in late 2026, early 2027 and just sort of your confidence around the timeline of that readout? Thank you. Sam I'm happy to take the question relating to Xywave. Yes, of course we've seen two multisource generics enter the market in Q1. As yet, we haven't seen any impact on XYWAVE business so far. As I mentioned previously, we continue to have strong payer coverage supporting the use of Xywave. So nothing really has changed in the nature of our business for xywave. But of course, you know, it is still early days for the generics in the market. We do anticipate that, you know, as their volume grows through the course of the year, then we may start to see some actions taken by payers that may include, you know, utilization management. We don't know yet, but we're very confident that XYWAVE offers a really important and differentiating option for patients, being the only low sodium option, the only product approved for ih, and of course it has already demonstrated how effective it is as a nighttime agent and the impact that has on daytime symptoms. So we've obviously carried strong momentum throughout the last 12 months and into this year and we're in a strong position as we go into Q2. Maybe I'll hand over to Rob for the question on Modezo. Renee Rob, I'll go ahead. Sam, just add one thing real quickly as we think about what we're seeing with XYWE before we go on to Rob for Mode. So certainly the dynamics are a bit unusual in the first quarter given reauthorization, but I do think we're seeing continued support by patients and physicians of the unique benefit that XYWAVE offers. From looking at the net patient ads. Lumrise net patient ads were announced roughly 100 ADS this quarter. Like the 100 last quarter, our numbers just in narcolepsy have been larger than that in each of those two quarters. Again, I think underscoring this unique benefit that only XYWAVE can offer and the safety advantage it confers being valued by patients as well as physicians, we're in a great position from that perspective as well. As we think about the back part of the year and how things could play out. OPERATOR So ami, the action trial is an OS based endpoint and there's one interim analysis and then a final analysis. The projections we gave are based on our current understanding of the events because it is an event and certainly if the events slow over time, that could change. But we'll update as appropriate as time goes on. David Hoag (Equity Analyst) Thank you. One moment for the next question. And our next question is coming from the line of David Hoag of Deutsche Bank. Please go ahead. David Hoag (Equity Analyst) Hey there. Thanks for taking my questions. So I first wanted to ask on the timing of a potential NCCN guideline incorporation for xanadatamab and GEA, do you have any sense of relatively when that might occur versus the PDUFA date? And how important is a category one recommendation to drive uptake? And then in breast cancer for Xany, I wanted to get a sense of how you're thinking about the opportunity size in the different settings. So obviously you're looking at posting her two, but I think you're also looking at Neo adjuvant and adjuvant. David Hoag (Equity Analyst) And so I was just curious as to your thoughts on size of the opportunity in those various settings. Great. Rob On the NCCN guidelines, you know, we proactively submitted the abstract data because it was available. We will certainly update NCCN with the full manuscript as soon as that's available and we hope that gives them everything they need to make a prompt decision on that and adoption, which we expect. Certainly we think the data speak for itself. Head to head against Herceptin. Zanadatumab definitively wins. Clear that tizalizumab is adding and there's likely to be a synergy between xanadatamab and tizalizumab as demonstrated by the activity in the PD L1 negative subset supporting its use up front with tiszalizumab. And so we think those data speak for themselves and that should be reflected in nccn. Sam This does conclude. Sorry, sorry, just to finish off the remainder of that question there. Yeah, I mean NCCN guidelines inclusion obviously important. We think that the data supports a Category 1 inclusion. If it comes before the launch, then that will open up access ahead of regulatory approval. Of course we don't promote that ahead of regulatory approval, but certainly that will make it easier for physicians to provide access to their patients. And yes, the breast cancer opportunity obviously very significant, significantly larger than either the BTC opportunity or the GEA opportunity with many more patients that can potentially benefit from xanidatamab. So we're excited obviously about that for the long term. Potential for Zihera. Renee Thank you. And that does conclude today's Q and A session. I would like to turn the call over to Renee Galla, CEO, for closing remarks. Please go ahead. Thanks, Operator. I'd like to close today's call by thanking all our partners and stakeholders for their continued competence and support. We look forward to sharing further updates on the potential approval of Vanny datamab in GEA and additional meaningful progress with you over the remainder of the year. So thank you for joining us and have a great day. OPERATOR This concludes today's program. Thank you all for joining. You may now disconnect. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.