Great. Good afternoon, everyone. My name is Jessica Fye. I'm a biotech analyst at JPMorgan, and we're continuing the 44th Annual Healthcare Conference today with Jazz. First, you're going to hear a presentation from the company CEO, and then we're going to go into some Q&A. So if you're sitting in the room and you have a question, just raise your hand, someone will bring you a microphone, or you can always submit them online to me, and I can read them up here. So with that, let me pass it over to Jazz's CEO, Renée Galá.
Great. Good morning, everyone, and thank you, Jess, and thank you, J.P. Morgan, for having us. You know, I have been attending this conference for a number of years, but this is my first as Jazz's CEO. It's such an honor to be in this role and to build upon Bruce Cozadd's amazing legacy. I'm also excited to be in a position to work with our board, our management team, and our employees to boldly move Jazz forward, to realize the potential that I see for us to bring life-changing medicines to patients, to drive into the most incredible work experience that our employees are able to have, and to create meaningful value for our shareholders. So today, I'll recap our accomplishments for 2025.
I'll then spend the bulk of my time talking about where Jazz will compete and win in the future, and why we're confident in our ability to do so with this new strategy, which you'll see has evolved to capitalize on Jazz's strengths, and then I'll close by highlighting key upcoming milestones, and then we'll turn it over to Jess for Q&A. Before I begin, I'll direct your attention to Slide two. I will be making forward-looking statements today. Please consult our SEC filings on our website. You can find more information there about the risks and uncertainties about our business. Our 2025 guidance today, as we make references to it, it is as of when we provided it on November the 5th, with the exception of total revenue guidance, which we reaffirmed yesterday.
Turning to Slide three, 2025 was an outstanding year for Jazz, one that we're proud of and one that we think provides us immense confidence in the future. Starting with R&D and Ziihera, we released top-line results in November of our HERIZON study. By the way, if I refer to Ziihera or zanidatamab, those are interchangeable. This is the phase III registrational first-line study of zanidatamab in gastroesophageal adenocarcinoma, or GEA. The data were presented in detail last week at ASCO GI here in San Francisco, and we presented over two years of median overall survival. This is unprecedented in this setting and strongly positions zanidatamab to become the new standard of care in HER2-positive first-line GEA. Also, at ASCO last year, we presented practice-changing results for Zepzelca in first-line extensive stage small cell lung cancer in the first-line maintenance setting.
This data, based on its compelling overall survival benefits, is expected to drive Zepzelca into becoming the standard of care in this setting. Moving on to the commercial front, shortly after acquiring Chimerix in April, we took Medaso forward to get rapid approval and then launch that product. The launch is now exceeding our expectations, reflecting the value that physicians see in this medicine treating patients with H3K27M-mutant DMG. I'll just note this is the first and only drug approved in this setting. It represents a significant advancement in this field, which has seen little to no innovation in 60 years. Also, last year, we received approval and then launched Zepzelca in that first-line maintenance setting. The launch is off to a great start. Epidiolex achieved $1 billion in sales last year, reaching blockbuster status for the first time.
And we also achieved record total revenue for the company, finishing the year towards the top end of our existing guidance range. In corporate development, in addition to the Chimerix acquisition, which added Medaso, it brought us clinical programs and also gave us significant neuro-oncology expertise, which we plan to build upon. We also in-licensed a best-in-class Kv7 activator molecule. It's at preclinical stage from Saniona, enabling us to continue to build on our epilepsy franchise. Finally, on the corporate front, we resolved all major litigation that we were facing. This includes all litigation with Epidiolex and Defitelio, giving us confidence in the durability of Epidiolex. Under these settlements, we do not expect generics to come to the market before the very late 2030s. We resolved all litigation related to Xyrem antitrust, as well as all litigation related to Avadel.
And with these matters behind us, we can focus squarely on running our business. We also saw that our progress began to be recognized by the investment community. We increased our market value last year by over $2.8 billion. And when you look at these impressive achievements for 2025, it's simply not possible without the dedication and talented employees that we have at Jazz. It is their efforts in 2025 that enabled us to achieve record revenues, to launch multiple practice-changing products or indications into the market, to generate clinical data important to our future, and also position the company for success in 2026 and beyond. Now, as I shift to strategy, I'll describe a refined strategy for Jazz. This is how we intend to compete and win in the future. But in doing so, it's important to understand where the company has been.
So turning to Slide four, I'll break our history up into two roughly decade-long periods, one from the company's founding in 2003 to 2013, and one from 2014 to 2025. Jazz, like many companies, began as a private startup. We had no products, no pipeline, no technology, but a very clear vision on the impact that we wanted to have for patients and employees. We successfully transitioned to a small publicly traded company with aspirations to make a significant impact on the lives of patients with neurological and psychological disorders. We then evolved into an established, highly profitable enterprise with a thriving sleep business and an emerging presence in oncology. We built substantial late-stage development capabilities, regulatory capabilities, and commercial capabilities to support our business. And during that time, we created significant shareholder value, exiting that period with revenues approaching $900 million and growing, heavily concentrated on Xyrem.
In the second period, the evolution continued. We greatly expanded our presence in oncology, building a billion-dollar-plus revenue franchise. We acquired GW Pharmaceuticals, providing us with a presence in epilepsy, which we continued to expand, again, creating another billion-dollar franchise. And this allowed us to significantly diversify our revenue. Our business became more sustainable and scaled as we went from less than $900 million to more than $4 billion in revenue. And we continued to hone our capabilities in late-stage development, commercial. We added research. We added early clinical development capabilities, patient support services, and other capabilities to support our growing business. But despite progress over that time that was significant, our value remained relatively stable, with value from new products being offset from declining value from Xyrem.
Now, as we look ahead to the next decade and beyond, we'll leverage our significant capabilities built over this 20+ year period to deepen and expand our commitment to rare disease. We'll aim to compete and win in our existing areas, but also in new areas of rare disease, strengthening our R&D along with select other capabilities, with the objective of realizing the full potential of the existing assets that we have, including Ziihera, and expanding our portfolios strategically, both organically, but also with disciplined corporate development, with an aim of benefiting even more patients and building a stronger and more valuable company. Historically, we've described ourselves as being actively in neuroscience and oncology. But in terms of our strategic expertise, the products that we have supported, the markets that we've been in, they're in what most people would refer to as rare disease.
We've been highly successful in this space with two of the top rare disease drugs in Xywav and Epidiolex and multiple growing oncology products. As you'll see on Slide five, going forward, we will sharpen our focus on rare disease in these areas that we are currently in: rare sleep, rare epilepsy, rare oncology, but also expanding into new rare therapeutic areas. We'll do this by leveraging our proven capabilities as well as our size, our agility, and our footprint. Now, you may ask why focus on rare disease? You'll see there are a number of dynamics on Slide six that make rare disease attractive for Jazz. First, many rare diseases still have very high unmet need. Patient populations are small, making the call point relatively concentrated, usually serviced by relatively small and focused field teams. Patient and physician services can provide additional differentiation in the market.
There can be lower competitive intensity and a lower rate of technological obsolescence. Peak revenue can be highly attractive for a company like Jazz, although it may not be large enough to attract the attention of large biopharma. And regulatory and policy dynamics continue to be favorable in this area, with a high level of collaboration between sponsors, investigators, and advocacy to bring new innovation to patients. And given the capabilities that we have built over the years and our long-standing commitment to bring life-changing medicines to persons with serious disease, we do believe Jazz is particularly well-suited to have a significant impact on patients with rare disease. Now, how will we compete in rare disease? On Slide seven, we'll continue to look for areas of significant unmet need. We'll lean into innovation as we have with products like Ziihera, Medaso, and Rylaze.
We'll focus on medicines that are highly differentiated and can become a new standard of care, providing clear improvements in outcomes for patients and value to the healthcare system. Now, we will approach opportunities in areas where we have existing capabilities differently than when we're moving into new areas of rare disease. So in areas where we have deep expertise, like sleep, epilepsy, and oncology, we will leverage that expertise to invest along the full spectrum of research, development, and commercialization. And as a result, corporate development deals in this area could span from preclinical all the way to marketed assets. When entering a new area of rare disease, we intend to take a more measured approach to clinical risk.
You can expect the corporate development deals in this area would focus on assets that have achieved proof of concept or later, or that have the potential to provide a meaningful benefit over existing areas where we already have a validated target. Our goal ultimately is to build each rare disease area that we enter into a robust billion-dollar franchise over time, like we've done with sleep and epilepsy and oncology. Ideally, we'll do this with multiple assets to be able to efficiently leverage our capabilities, our footprint, but also to enhance our profitability. We'll continue to build on research and early development capabilities, applying them in areas where we have deep expertise to develop novel therapies with a focus on validated mechanisms and targets, following the science, being disciplined and data-driven.
In the near term, you should expect to see Jazz-d iscovered molecules coming into the clinic. And over a longer arc of time, we would anticipate more of the products that we are bringing to market will come from our internal efforts to complement the innovation we're bringing in from corporate development. We also plan to bolster our customer centricity and digital AI capabilities. In fact, by the end of this year, every single Jazz employee will be trained in AI, and we have additional operational objectives for embedding more AI into our business on a day-to-day basis. So you may ask, how has your strategic focus really changed? What is different? And there are a number of things about this strategy that are different. And I'll give you one example.
In the past, we contemplated opportunities in neuroscience that were broad in terms of the number of patients and physicians, the size and scope of the programs, neuropsych indications, for example. These are areas that we won't prioritize going forward. Now, with that being said, we recognize that we very likely may come across molecules that we're bringing into rare disease that will have broad applicability. We have a perfect example of that in our portfolio right now with zanidatamab. When we brought in zanidatamab, we licensed that drug for BTC and gastric cancers, two rare cancers. And we now clearly have a much broader opportunity, including in breast and other lines of therapy. So we will continue to maximize the value for Jazz when we find ourselves in these cases. And that is exactly what we intend to do with zanidatamab.
Now, why do we think that we can be successful in this strategy? Well, we are leveraging a strong track record of success over a number of years already operating in these areas. And as we build on this track record of success in multiple rare diseases already, we do believe we can further broaden our foundation, investing further in our three major value pillars at Jazz: R&D, commercial, and corporate development. We have recent successes in each of these and a number of proof points that I'll go through. Starting with R&D and Ziihera on Slide nine, we have a highly differentiated HER2-targeted agent in Ziihera, and it is now meaningfully de-risked, a cornerstone of our future growth that we believe has the potential to be a $2 billion-plus commercial opportunity. This represents both successful corporate development and successful R&D.
We secured zanidatamab based on our strong belief in its MOA for $50 million upfront. Our initial thesis, as I'd mentioned, was based on BTC and GEA. After positive BTC data, we brought this compound in, continued to advance into additional clinical studies. Through our continued R&D work, we now have a high-value asset with data across a number of tumor types and the potential to be the HER2-targeted agent of choice to be able to extend life for patients. Underlying our confidence on Slide 10 is the positive phase III data from the HERIZON GEA study that we presented last week. These data are unprecedented, with overall survival exceeding two years and remarkable consistency of benefit across the relevant subgroups. Our confidence in zanidatamab's potential has only increased. The hypothesis you're testing here that we were testing was, what is the better HER2-targeted agent, zanidatamab or Herceptin?
zanidatamab outperformed Herceptin across all efficacy measures in this study. Last week at ASCO GI, the data were largely characterized, sorry, widely characterized as practice-changing and supportive of zanidatamab becoming the preferred HER2-targeted agent of choice for GEA patients. As we progress towards realizing the full potential of zanidatamab, we do have a number of exciting near-term milestones, beginning with GEA. We plan to submit our sBLA filing in the first half of this year with potential NCCN inclusion and then approval and launch occurring later in the year. I'm also happy to disclose today that we learned earlier today that we are eligible to submit under the Real-Time Oncology Review, or RTOR, which should allow us greater speed and communication interaction with the FDA.
Looking to the coming years, we expect to have multiple data readouts across indications, including in metastatic breast cancer, with our first readout from EmpowHER phase III in late next year or early the following year, and we're also studying Zani in novel combinations and looking at additional areas of unmet medical need. Alongside R&D, we've also demonstrated incredible commercial performance in rare disease, two existing billion-dollar products in both rare epilepsy and rare sleep, as you can see on Slide 12. In rare epilepsy, since the GW acquisition in 2021, we've driven substantial growth with this product, bringing it to blockbuster status last year. We believe Epidiolex is a highly durable, long-lived asset, and with this additional durability, we have the ability to continue to do more development, including more formulation development, and generate more data we think is useful for the product.
In rare sleep, we have established market leadership in treating patients with rare hypersomnias for nearly 20 years. We've brought forward new products such as Xywav, which is differentiated as the only low-sodium oxybate and the only product approved for idiopathic hypersomnia. We've established best-in-class patient support services with this program and generated meaningful data for patients. And I'll note that this program generates meaningful cash flow for Jazz, allowing us to further invest in other parts of our business. Moving to Slide 13, corporate development will also continue to be a meaningful focus for our company. I mentioned the acquisition of Chimerix earlier. This acquisition brought us Medaso, which I mentioned was previously approved in August as the first medicine in this class approved ahead of its PDUFA date. Upon launching this product, we moved very quickly to ensure that patients, physicians, all centers knew about this product.
But there was already such strong advocacy and familiarity that we've seen meaningful uptake with nearly $50 million in our first four and a half months on the market. We've also generated significant additional value with this acquisition. With this acquisition, we recognized a deferred tax asset that will reduce our future cash taxes by approximately $200 million. And we're also pleased to announce this week that we sold our Priority Review Voucher for $200 million in gross proceeds. As we look at 26 and beyond, we have a first-line study, the phase III ACTION study underway. Enrollment here is ongoing, and we expect our first interim OS readout at the end of this year or later next year. We expect not only would this study support our first-line indication, but also ex-U.S. regulatory filings.
So closing on strategy on Slide 14, we are highly confident in our ability to execute on a strategy in rare disease. We have significant capabilities, and we're building additional capabilities to strengthen our ability to support this market. We have the opportunity to invest in our pipeline and research development, in the growth of our commercial products, and also in corporate development, where we think there is a lot of substrate for us to be able to transact in, both in our existing areas of sleep, epilepsy, and oncology, but also in other areas of rare disease. Importantly, we do have a very strong financial position to support both our internal investments as well as our external corporate development.
We generated nearly $1 billion in cash in the first nine months of last year and ended the third quarter with over $2 billion of cash and investments on the balance sheet. And so I'd now like to close by reviewing our upcoming milestones as we look to 2026 and 2027. Starting with research and development and Zani for GEA, as I'd mentioned, we plan our sBLA in the first half of this year. We have already submitted to NCCN Guidelines, and we expect a peer-reviewed publication to be coming in the relatively near term. We also have our second interim planned on this HERIZON GEA study that we expect in the middle of this year, with the opportunity for approval and launch before the end of the year. We also continue to be laser-focused on the broader zanidatamab program.
Our EmpowHER breast cancer study is enrolling nicely. We have enrollment planned to complete in the first half of next year, which would give us the ability to read out late next year or early the following next year, our top-line readout. This is also an events-driven study, as was GEA, so those timelines are subject to both enrollment and events. And I'll note that this patient, sorry, this study is enrolling patients that have progressed on or are intolerant to an HER2. So it will be the first study to read out data of this nature in this setting. Importantly, our data has also been, I would say, highly de-risked. This study, given that we have now seen in GEA that zanidatamab clearly outperformed Herceptin in this breast cancer study, the underlying experiment is again zanidatamab versus Herceptin.
It gives us additional confidence in the outcome of this study. As I'd mentioned, our dordaviprone study, which is Medaso, is expected to read out late this year or early 2027. Moving on to commercial and our outlook for 2026, we do intend to provide guidance in February at our earnings call the way we normally would do. As we look at our overall outlook, we see the potential for robust growth in our non-oxybate revenue in that part of our portfolio. We have a number of exciting opportunities with Medaso, Ziihera, Zepzelca in the first-line maintenance setting, as well as Epidiolex. Our outlook for sleep is still somewhat dynamic, given we do have generic versions of high-sodium oxybate that will be coming into the market.
As a reminder, Hikma, our largest authorized generic, will not be launching a generic this year, but we are aware of two other companies that have expressed their intention to launch. In this area in sleep, we are entering 2026 in a very strong position. We have over 16,000 patients on therapy. We are the only low-sodium oxybate on the market, which is very important for patient safety, and we have excellent payer contracts in place as we enter the year. Then finally, on corporate development, we fully expect to announce one or two or more deals in 2026. We do aim to continue growing our business and optimizing our future value through corporate development. I'll close by thanking my Jazz colleagues for all of their efforts, also thanking our shareholders for their continued confidence and support.
And then I'll invite Rob and Sam and Philip for Q&A and turn it over to Jess.
Great. Thanks. Thank you. So as a reminder, if you have a question in the room, feel free to raise your hand and we can bring you a mic. But I will start. So maybe just starting with kind of the renewed strategy with the focus on rare disease, what are the operating margin implications of the updated strategy?
I would say if you look at our business the way it's structured today, many of our underlying products are essentially rare disease products. So while we don't give forward-looking operating margin guidance, I would say continuing to build on our existing verticals of sleep, epilepsy, and oncology will allow us to continue to get more out of those areas and work to enhance profitability. It's also our goal to do so, to do the same when we enter into new areas. And then when it comes to optimizing and getting the absolute most out of zanidatamab, we will be investing there. We'll be increasing the breadth and depth of that development program. And so that will be also dynamic as we think about the overall profitability. Phil, would you like to comment further?
Sure. Is that Mike Lime?
These cards are not the top.
Oh.
User error. Sorry about that. So, no, Jess, I think the strategy is a larger continuation of what we have been doing. This is a space that in the past has been highly profitable for us. We would expect going forward that will continue to be the case. We will be focused, I think, primarily on identifying opportunities to drive long-term growth and value. So while we'll be cognizant of the implications for profitability, the focus will not be on this quarter or next quarter profitability. It will be on building a very strong, fast-growing business that's highly valuable and more valuable in the future than it is today.
You mentioned Jazz discovered products entering the clinic over time. How soon could that happen? And where are the company's discovery efforts focused?
Without giving a specific timeline, we have actually some things that were discovered at Jazz that are pretty soon to be in the clinic. It would really follow what Renée had outlined from a strategic point of view. We don't have a huge medicinal chemistry effort, for example, but it's a good group. In areas where we think we can compete in terms of developing novel agents and fit with our strategy, that's where we're focused. We're already seeing some of those come forward.
And then.
Quick question.
Sure.
Hi. So Amneal launched their Xyrem generic today. Could you talk about how you think that'll impact pricing for your oxybate franchise?
Yeah. So thanks for that question. Well, just as a reminder, I mean, let's just be very clear that our business, our sleep business, is primarily Xywav, which is the only low-sodium oxybate on the market and the only product with an idiopathic hypersomnia indication. With Amneal's launch, and potentially there may be more that enter into the market in 2026, they're obviously high-sodium oxybate generics. And of course, we would expect to see that impact Xyrem, our high-sodium oxybate, as well. Our focus during 2025, and you'll have seen in some of the results that we've disclosed during the course of last year, showed that our focus on differentiating Xywav in the market has been very, very impactful for physicians. Quarter three, we saw 450 net patient adds. And that momentum really has not slowed during the course of 2025 in the face of authorized generics on the market.
So we feel very confident in the differentiation that is appreciated by clinicians and by patients and all of the other wraparound services that we put around Xywav, such as in-person nurse support programs, etc. Having said all of that, of course, there's a lot that we don't know. So how many generics will enter the market? What will their pricing strategy be? We're entering the year with exceptionally good payer coverage, so we couldn't be in a stronger position with Xywav. But some of these unknown factors are yet unknown, so we'll have to see how they play out in practice. Just to follow up on that, another investor question is, how do you approach giving guidance this year in light of this kind of dynamic oxybate environment?
Sure. So we'll be providing guidance on our February 24th, fourth quarter earnings call. We had just made a move coming into 2025 to provide total revenue guidance. You may recall that in prior periods, we had given guidance not only for total revenue, but also for neuroscience as well as oncology revenue. So we're having discussions on what's the most useful for investors for 2026. Certainly, we'll give total revenue guidance. I think very likely we would give some level of then color commentary at a minimum of how we see the non-oxybate portion of our business growing, where there are the normal uncertainties, but not this unusual uncertainty that we have with generic Xyrem coming into the market in 2026.
And then I would assume we'll give some level of where we see the market currently for generic Xyrem, what it means for Xywav, and based on those assumptions, sort of how that flows into the total revenue that we're expecting for the full year. This is a dynamic that we have a lot of uncertainties on. We do expect that there will be generics. We just heard now, obviously, one's coming in, and that there could be some others. But this is something that is less or more complex, I think, than other standard generic launches. This is a product that has to have REMS associated with it to be able to ensure there's not diversion of the product, etc. So this is something that the generics will have to build over time, their registration of physicians into the REMS, registration of patients into the REMS.
Likely this would build over the course of the year, and impact would likely be not seen early in the year and be seen more later in the year to the extent we're seeing an impact. First quarter, as Sam mentioned, we're very, very strongly positioned with the payer contracts we have, with the momentum we have coming into the year, significant recognition of physicians and patients of the benefit of low sodium. Xywav is the only product that will be able to offer that benefit. Neither the generics nor branded products have that ability to offer that safety benefit that comes with Xywav that we have seen be very, very impactful for physicians and patients, we would expect for payers as well.
Maybe coming back to the kind of the rare disease strategy, there are a number of rare disease companies that have a stated goal of acquiring other rare disease assets. So how do you position Jazz to kind of best compete for the assets that are for sale?
Yeah. Well, first of all, I look to what we were able to achieve with the Chimerix acquisition, what we were able to achieve with the GW acquisition, and be able to actually deliver on our goals to deliver a strong launch with Medaso and to create significant additional value through the sale of our priority review voucher, and being able to understand in this type of area the importance of truly understanding the patient, understanding advocacy, how to connect well and collaborate well with investigators and with HCPs. So I think that's been a long-standing strength of Jazz over time. And then in terms of how we really compete, we have a meaningful footprint that can enable us to make medicines available.
In terms of how we think about where we want to compete, we're most focused in those areas that I described that have sort of the phenotype of the characteristics that will fit within our existing business.
Maybe turning to the recent Zani data, just two questions here. First, can you put the recent data into context with KEYNOTE-811? And second, on OS for the Zani d oublet versus Herceptin doublet, where I think the upper end of the confidence interval is like 1.01, what gives you confidence that that could be stat-sig at the next interim?
Sure. So thanks for the question. On the first one, I just want to remind everyone that what was tested here was what I think is the most important question in the field, which is what's the best HER2 agent to be used in this setting. Gastric cancer that's HER2 amplified is highly HER2-driven. There's activity with chemotherapy. There's incremental activity with PD-1s. But the HER2-targeted therapies are what really make a difference in this disease. So the study was designed to test that head-to-head, Zani versus Herceptin. And as Renée alluded to earlier, definitively, no matter how you look at that, Zani prevails and should become the standard of care for this line of patients.
The study also looked at whether the addition of a PD-1 inhibitor, in this case tislelizumab, would have incremental benefit in the context of zanidatamab the way it has across multiple other studies to this point. And those data were definitive. But what turned out to be very differentiating is that the effect was positive irrespective of PD-1 status. And I think that's when you look at the overall intention to treat results, where we're seeing almost 27 months, 26- 27 months median overall survival compared to KEYNOTE-811, which was about 20 months. But importantly, this drug now has data to show that it can be used irrespective of PD-1 status. And we think that makes sense based on the differentiated mechanism of action for zanidatamab, which is much more immune active. We know that it fixes complement, activates the complement cascade.
We know the Fc function is highly active in terms of recruiting NK cells and macrophages. So essentially turning a cold tumor hot in this context, allowing patients to use the Zani triplet in all comers without having to test for PD-1. So compare very favorably in general, but specifically differentiated on the PD-1 issue. And then your question about probability of succeeding at a later date, we had a relatively small amount of alpha spent at this interim analysis for overall survival. We have a second interim planned and then a final analysis. So we have two more bites at the apple there. We recognize that one thing that's really differentiating Zani is the duration of response that comes through in the presentation last week and will in the manuscript.
And so we think that given how differentiated it is there, with additional follow-up for those patients who didn't have a lot of follow-up, that they'll continue to contribute to separation of those curves over time. So that next interim analysis is expected mid-year, depending on how the events roll out. And we think we have a good shot there, certainly by the time of the final analysis.
Great. With the filing going in and the interim potentially happening while the review is underway, is it possible if you do hit stat-sig at the next interim that that could get in the label?
Absolutely. And again, just to remind folks that the regulatory standard here is not stat-sig OS. I mean, the FDA has been clear that a large PFS difference that was stat-sig with support of OS data, recognizing that in this trial, patients on the control arm could get subsequent Keytruda, which wasn't available, of course, for KEYNOTE-811. So we were quite pleased to see, especially in Arm C, that we already had stat-sig and we came so close in Arm B on overall survival at this first interim. So it may well be available during the review, could end up in the initial label. If it's not, of course, we'll supplement the label. As Renée mentioned, very pleased to hear from FDA that they are allowing us to use the Real-Time Oncology Review.
I think that shows their level of enthusiasm about the data and certainly enables us to speed the process as much as possible.
Great. We are out of time, so we'll stop there. Thank you.