Jazz Pharmaceuticals plc (JAZZ) Earnings Call Transcript & Summary

Okay. Good morning, everyone. Thank you for joining us at the UBS Virtual Healthcare Conference day 1. I'm excited to have the Jazz management team here with us for a fireside chat. So I'm joined by Jazz Chairman and CEO, Bruce Cozadd; former GW Pharma CEO, Justin Gover; Renee Gala, Jazz' CFO; and Rob Iannone, EVP, R&D and Chief Medical Officer. Welcome, and thank you all for making time for us.

Happy to be here, Esther.

Great. So Bruce, perhaps we can start off with a big picture question as Jazz is positioned to become more diversified and you have a portfolio that provides you with multiple levers to pull. Where would you focus your resources and attention over the next 12 -- 24 to 36 months?

Love the softball question to start, thank you. And glad to be here. And let me just say to all the listeners, we will make forward-looking statements on this call. So please see the risk factors contained in our SEC filings. So in terms of what to be watching for right now, we are in the midst of an extraordinary productive period for the company with 5 product launches across 2020 and 2021 that are increasingly diversifying our top line revenues as they're growing quickly. And the closing of the GW acquisition earlier this month just accelerates both our revenue growth and our diversification. So 23% of our revenues in the first quarter of 2021 came from newly launched products. We anticipate that could represent about 65% of our total revenues next year in 2022. And while we're seeing this rapid growth in top line, we're also progressing a very interesting R&D pipeline across neuroscience and oncology. So with these 3 commercial franchises in sleep disorders, in epilepsies, in oncology, where our business did north of $500 million for the first time last year and we've guided toward closer to $800 million this year, we've got 3 great franchises to grow and a pipeline that we think brings us sustainable growth over the mid to long term.

Great. So that was probably the only easy ball you're going to get. So I mean you're at the midpoint of this year, and as you say, the GW transaction is now closed, and I assume you're going to guide potentially in mid-June, what are some of the pushes and pulls that you're looking at as you're considering your -- revising your guidance?

And maybe I'll ask Renee to weigh in on that one.

Sure. Yes, I'm happy to. So as we stated at our last earnings call, we reiterated the guidance that we had provided earlier in the year for Jazz stand-alone. And so as we're considering our updated guidance, which will include the full year of Jazz plus approximately 8 months of GW, obviously, we want to ensure that we continue the strong momentum that the GW team has had with Epidiolex, investing behind that important product as well as investing behind the pipeline. We're excited about the nabiximols program. And we're excited, quite frankly, in addition to bringing in this incredible team from GW, we're now bringing in a research organization that we'll have internally. So of course, we're balancing both ensuring that we continue to focus on investing properly in our continued commercial launches, now Epidiolex, our combined pipeline, the people and making sure that we stay on track for meeting our leverage targets, which, for next year, is to get below 3.5x net leverage, and we're in a great position to be able to do that.

Great. Thanks, Renee. So in terms of -- as you're kind of thinking about the business operations and planning to -- can you maybe talk a little bit about how you're planning to stage the international expansion that I expect you would have to undertake to fully leverage GW, but also JZP-458 and Xywav?

Yes. So we've got the opportunity to really grow our European and international business very nicely over the upcoming years. Historically, Jazz has been a little overweight U.S. And in part, that's been because our European and international business has been hem/onc only until very recently. We did our first neurology launch in May of last year with Sunosi in Germany, and we're continuing to roll that out over multiple countries. Of course, GW has been in the process of the early stage of European launch with Epidiolex at the same time. So we're now going to bring those organizations together and have a stronger combined neurology presence as we continue to progress existing and future products. So we think over time, as more of our products are global in their promotion, Jazz might start to emulate other companies in our industry where a far greater percent of revenues than our historic 10% would come from those external markets. So think of it as a smaller business today with a faster growth rate over time. We haven't been specific, Esther, on JZP-458. We're targeting a near-term U.S. launch following FDA approval. But we have said we're already in conversations with regulators around the world, including in Europe and in Japan, to expand that to a global product as soon as we can.

Got it. So maybe we can -- I'm going to drill down on a couple of products here. So a big focus for investors is idiopathic hypersomnia and how to sort of quantify that market, if you will. And you shared some patient stats. And at least initially, you appear to have a captive audience with both physicians and the patients. So as you're thinking about the launch curve here in terms of patient uptake, what are some of the things that you would have us consider? I mean, should we expect a similar patient uptake as what we saw with Xyrem a decade ago? Or have the prescriber and patient dynamics changed enough to allow a steeper curve?

Well, the growth of oxybate in our hands since 2005 has been steady over a long period of time. But the prescriber overlap now tells us that about 90% of the prescribers for the idiopathic hypersomnia are already in our target narcolepsy audience. So we think we've got physicians with good experience at diagnosing and treating IH now with an effective agent, we believe, in Xywav, based on the clinical data we presented last month at a major medical meeting. So we are excited that people will understand this can provide the first FDA-approved therapy for idiopathic hypersomnia which is a serious and rare sleep disorder. In terms of how fast that will be, we're doing disease education, as you would expect, around the proper diagnosis of idiopathic hypersomnia. We want to make sure patients and physicians do understand how to use the drug safely. This is a drug with a black box warning. It needs to be used carefully by patients, including having them discontinue alcohol. So we want to get that launch right in terms of benefit to patients, but also limiting risk to patients. But this is very exciting for idiopathic hypersomnia with no approved treatments and the large effect size we saw in our clinical data.

Got it. And in terms of the REMS program, outside of sort of updating, including idiopathic hypersomnia at the right time on the label, what specifics changes might you have to make to ensure compliance specific to this population?

Yes. I'm not sure it's -- I'm not sure, Esther, I trying to indicate we need to make any major changes other than we're dealing with a new patient group that hasn't historically had access to oxybate due to payer restrictions for on-label use of Xyrem and now Xywav. So we just want to make sure we're doing that responsible job of helping people understand the benefits and risks of our drugs, as I think we always do.

Understood. And then as you're thinking about the second half of the year, do you expect -- do you anticipate any gross to net impact with idiopathic hypersomnia launch? Or should we kind of be thinking about those dynamics similar to what we saw initially in the first half of the year?

Yes. I don't think there are any special considerations. Remember that unlike patients who might be moving from Xyrem directly onto Xywav, which, according to the clinical trials we ran, patients can move straight over dose for dose, idiopathic hypersomnia patients will be new to oxybate. And so they'll be titrating up on dose over time, so the curve will look a little bit different there. But from a pricing -- net pricing perspective, I don't expect major changes.

Okay. And then just sort of looking into the future for the oxybate franchise, specifically for narcolepsy, orexin inhibitors have been popping up in conversations. And as they potentially get further along in the clinic and assuming commercialization at some point, is there an opportunity for these to be used in combination with the low-sodium oxybate? Or how do you think the market evolves with different mechanisms for this patient population?

Yes. I'd love for Rob to weigh in on that.

I mean direct answer is yes, I do think there would be an opportunity to combine the drugs. Obviously, the orexin mechanism is very interesting. It's central to sleep wake. We know that there are drugs that have been used to antagonize the system that can be used for insomnia. So it's a target and a mechanism that's very interesting. The data are early, though, in terms of how effective they are, for example, on cataplexy as well as other symptoms in narcolepsy, such as daytime sleepiness. But fundamentally, oxybate is a critical therapy for narcolepsy because it's given at nighttime, and helps to address some of the underlying root cause of narcolepsy. And by improving sleep at night, it then improves daytime symptoms around excessive sleepiness and is very effective in reducing, eliminating cataplexy in even the most severe patients. And it's often used in conjunction with daytime alerting agents to even improve alertness and minimize daytime sleepiness further. So I do think that as orexins develop and potentially come to the market, there would be the opportunity to combine them. But I don't see it as a replacement for oxybate in the patients who derive significant benefit from it now.

Understood. I have a question here in e-mail. So the listener wants to know with regards to the oxybate, can you talk a little bit about your litigation with Avadel and anything you can share on next steps there?

Yes. There's probably not a lot we're going to say, Esther, about ongoing litigation. We did recently commence litigation around a number of Jazz patents that go to safe distribution of oxybate and an extended release formulation of oxybate, but that litigation will play out over time. I don't think we've got other comments to make on that right now.

Understood. Okay. So moving on to another exciting topic, Epidiolex. Now that the transaction is closed, maybe can you give us a little bit more color in terms of how the integration is progressing and what your key priorities are in consolidating operations for the 2 companies?

Yes. Well, I would say we're super early on in integration, right, having just completed the deal a few weeks ago. But we're really impressed with how GW has been effectively launching Epidiolex across indications and across geographies. And so our focus has been don't interrupt their momentum. The target audience for the sales force for Epidiolex is different from our target audiences. So in general, the field-based personnel on the commercial and the medical side are unaffected by this transaction, meaning they're continuing to be in the same territories with the same managers, with the same goals and objectives as they had prior to the transaction. And so when we think about integration, there are certain parts of the company, particularly G&A functions, where we are doing some integration, but there are also large parts of the organization where what we really want to do is let them succeed. Make sure they've got the right resources to maximize the opportunity with Epidiolex to bring it to more patients who can benefit from that therapy, to continue to progress the clinical programs, both late stage and early stage, that GW has been pursuing. And over time, I believe there will be some synergies, some positive synergies in combining our R&D and GW's R&D across neuroscience, where there may be opportunities we can complement what the other company has been doing and be stronger together.

Understood. And we touched on this a little bit before, but Europe is a pretty big opportunity for Epidiolex. So as you're kind of looking at the U.S. market dynamic evolving for Epidiolex, and if you can comment on those? And then also any thoughts on how you think Europe might be similar or different relative to the U.S. with regards to patient demand dynamics for Epidiolex?

Yes. Since we've got Justin on the line, let me ask Justin to comment on that.

Thank you, Bruce. Well, I mean, the European rollout of Epidiolex is still very much at the -- is really just getting going, actually. When you think about the way the pricing and reimbursement processes work in Europe, we were able to launch rapidly in the U.K. and Germany. And we've built up a European infrastructure to launch in other markets. We do already generate revenue in some of the other major European markets as well, but full launches are going to be happening as we go through the reimbursement processes, which all continue to go very well, actually. We also just got the TSC indication approved in Europe as well. And that will then go through a reimbursement process on its own as well. So all the signs so far actually is that the European opportunity for Epidiolex is very real. It's exactly what we thought it would be. A lot of the same dynamics that helped contribute to the successful U.S. launch exist in Europe, too as it relates to awareness of CBD, the unmet need in these 3 indications and more broadly within treatment-resistant epilepsy. And the key here has been to get the reimbursement right. As you know, once you get that right, you really then can have a long runway of success in Europe. And that continues -- the data is very compelling as it relates to the cost effectiveness of the product. So I think Europe will continue to be a very important part of the Epidiolex story over the coming years.

Got it. And in the TSC reimbursement process relative to the other indications, what are some of the dynamics? I mean, is it just -- is it very similar to what you saw? Or do you think there would be any differences in terms of how the product is priced for going forward with TSC?

No. I mean it's one product, it's one price. So it's really just about -- you can't be reimbursed for an indication until it's approved. So it's really -- it's just a matter of process and sequencing that add the TSC data into a new reimbursement process with the cost-effectiveness data that are specific to those studies. But the seizure reductions in TSC were very similar, as you'll recall, to the Dravet, LGS seizure reductions. So that just needs to play itself out.

Okay. And then in terms of the IP portfolio for Epidiolex, there was a patent that was filed. It was an almost composition-like patent back in 2019. Can you maybe give us an update on where that -- how that application is progressing? And if you have any thoughts on when we might hear a decision on that patent?

Yes. So that patent, as you said, continues to progress. We -- it's important to say it's one of many different patents that we have. But specific to that, we're expecting it to go to grant within the next year, probably early next year is our expectation. But the -- it really just adds to what is already a pretty comprehensive IP portfolio. We have 16 used patents in the Orange Book. There's more on their way. We have a formulation patent as well. And then there's composition-like patent is coming. Plus, of course, there's -- it's an unusual product with lots of complexity around it in terms of manufacturing, et cetera. So we've from the GW side, prior to joining Jazz, put a ton of effort and thought into the intellectual properties that relates to Epidiolex. And of course, as part of Jazz and now having been through the diligence processes, I think a high level of comfort on both sides around how we're going to play this IP story out for Epidiolex. There's a long runway for this product.

Got it. Okay. And then perhaps, Bruce, as you're thinking about future development of Epidiolex , how important -- or how do you think the current patent portfolio plays into that, and specifically, this particular patent?

Yes. I'm not sure I've got anything to say beyond what Justin's laid out. We, as part of our diligence for the transaction, were very interested in the growth potential of GW's on-market products and the potential of the pipeline, but also the durability of those assets. And our diligence went to that, both as regards existing IP, potential go-forward IP strategies, but also a lot of the innovation that's come out of GW that's reflected in how the product is produced and how easy or difficult that would be for others to emulate.

Got it. Okay. And then just sort of looking into the future, I mean, there are a lot of -- well, there's some gene targeted approaches in the clinic specific to Dravet and other seizures that are -- that have a genetic etiology. So as you're thinking about -- how do you think about these targeted therapies and whether that would -- and how that might fit into the broader sort of antiepileptic drug market? Do you see them as disruptive? Or would they be essentially another treatment in the arsenal for physicians?

Yes. I'm happy to have maybe Justin start and Rob add in as you'd like.

Yes. As you say, there's a lot of innovation looking at some specific therapies around treatment of some of these genetic epilepsies themselves. It's an interesting time for that space. I think as -- and fairly, very welcome. I mean anything that helps these patients as it relates to reducing or eliminating seizure burden is something that we would applaud. I think as it relates to Epidiolex, the broad sort of sort of context, if you will, for the Epidiolex development, it is, of course, the overriding challenge within epilepsy, around 1/3 of patients with epilepsy still have seizures despite antiepileptic therapy. And that's really the sort of treatment -- the patient profiles that Epidiolex is focused on. I think this is -- this will continue to be a need which Epidiolex will address for many years to come. So I think the innovation in epilepsy can comfortably coexist with the utilization of a drug like Epidiolex.

Understood. Rob, I don't know if you had anything to add to that.

Just an agreement that these are complex seizure disorders where it certainly would be welcome if a new therapy helped to address that. My sense is that while we're waiting to see how effective they are, those patients are likely to require multiple agents to control the seizures given the severity, and Epidiolex is one that potentially combines very well.

Got it. So in terms of looking at GW pipeline, can you maybe share an update on where sort of some of the clinical trials are and any meaningful catalysts we can expect over the next 12 months from that pipeline?

Sure. I'm happy to take that. So this -- it's a pretty exciting time for the GW pipeline starting, well, just firstly, with Epidiolex. Of course, there continues to be research in Epidiolex. So there's plans for another trial with another set of seizure types with Epidiolex to come, which we've not yet announced, but that's still in late stage planning. Beyond Epidiolex, though, we have nabiximols which is in Phase III -- multiple Phase III studies. Two out of the 5 Phase IIIs are underway. As a reminder, any one of these, we believe, would be sufficient to enable an NDA submission. The first study is, we believe, still on track with data by year-end, and the rest of the NDA is effectively being compiled. So whether it's that study or one of the future studies we're I think it's going to be in good shape to enable an NDA submission for nabiximols, which -- it was, when GW was a stand-alone company, I think, a really underappreciated opportunity. And I think it's going to be exciting hopefully to see the profile of that program elevate within investor minds of Jazz. It really could be a very big product over time. It has a very good strong life cycle management program for it within the field of spasticity, potentially beyond spasticity and a long durable franchise as well for that. We also have mid-stage studies for our other pipeline products in schizophrenia and autism underway, but data from those won't be in this year, but they'll be coming. And we also disclosed at the beginning of the year and just something to keep an eye on, not for near-term commercialization, but we started to expose investors to an early stage program where we were able to leverage our understanding of cannabinoid pharmacology to develop and synthesize new chemical entities that we [ thought had ] some enhanced properties over some of the naturally occurring cannabinoids, both within the field of epilepsy and some of the other areas as well. Those -- we're still on track for first-in-human for some of the early candidates there. And we're hopeful that as part of Jazz, that program will continue to accelerate over the next couple of years.

Got it. So the last program, first-in-human, what was the time frame for them?

Well, we have multiple compounds. The -- we did say as a GW stand-alone guidance that the first one of those would be expecting to go into humans this year.

This year. Okay. Got it. And maybe Bruce or Rob, as you're looking at the combined pipeline, do you see any opportunity for perhaps overlap with your current existing pipeline? Maybe -- you've talked about essential tremor as an interesting opportunity. So how are you thinking about prioritizing the cannabinoid pipeline?

So as you may know, we were interested in the cannabinoid space even before the GW merger. We had in-licensed a FAAH inhibitor, and our initial indication there is going to be in PTSD. So if you think about what's in the GW pipeline, what's in the Jazz pipeline, there's certainly opportunity to think about combining expertise around certain disease areas that we want to get into further, like essential tremor, like PTSD, but even the possibility of combining drugs ultimately, where more than one could be combined in the same disease area. So quite a bit of opportunity for synergy, and it's been exciting to help bring the company together over the last couple of weeks to begin to enable those discussions and planning around how the pipeline might synergize.

Got it. Okay. So I'm going to move on to 458 here for a little bit. That's another potential approval this year. So can you help us understand how the target patient population is currently managed with some of the historical shortages? And what would need to change in the treatment practices to incorporate 458?

Rob, you can jump in on that.

Yes, happy to. So I don't think anything really needs to change in terms of the treatment practice. Physicians know the importance of asparaginase in this patient population. I would point out a couple of things in favor of a smooth launch. We've been conducting this clinical trial with 60 or 70 sites in the U.S. through the Children's Oncology Group. We have a very close relationship with leadership at the Children's oncology group. We really recognize the challenge that exists currently. Now having said that, during the period of Erwinaze shortages, some physicians may well have been pressing on with frontline E. coli-derived asparagine even -- asparaginase even in the face of some hypersensitivity. There may have been a lack of checking for silent inactivation when there wasn't good alternatives. So there certainly will be some education around promptly switching when there's hypersensitivity to a reliable Erwinia-derived asparaginase like JZP-458, being vigilant about the possibility of silent inactivation, finding those patients who would not benefit from E. coli asparaginase if they have silent inactivation and making the switch over to JZP-458. So certainly, our medical teams are prepared to do that kind of education. But I think it's going to be fairly straightforward given the extensive involvement, and I would say, the consolidation of treatment protocols and paradigms in the U.S. at least.

Understood. Okay. So moving to Zepzelca here for a little bit. When you had in-licensed the product, you kind of guided to a $500 million in sales over a certain period of time, just in the second-line setting. So how -- I mean, assuming that guidance still stands, how are you thinking about the product now after seeing a couple of quarters and some of the other market evolutions as well with some of the drugs being withdrawn, the PD-L1 drugs being withdrawn from the U.S. market? How -- what are the implications of these changes? And not that you're going to change your guidance here on the call, but just kind of how you're thinking about that number that you have thrown out there before?

Well, to be clear, Esther, we did not throw that number out there, but we did say multi-hundred million dollar potential, and we certainly do think there's a lot of growth potential ahead of us in second-line small cell lung cancer. We're newly launched in the second half of 2020. We were pleased to see the rapid inclusion in the NCCN Guidelines. And we're seeing growth across the second-line patient types right now as we try to establish this as the new standard of care in second-line treatment. But maybe I can have Rob comment a little bit on what those recent changes in later line therapies will do to the market and then also where we're going with our development with Zepzelca.

Yes. So just to explain a bit, I think you're referring to KEYTRUDA and OPDIVO withdrawals in the small cell lung cancer setting. I would just remind you that those approvals were in late lines, and they occurred -- there were accelerated approvals in late lines, and they occurred before the approvals came for the 2 PD-L1 agents in frontline. And so once PD-L1s were being used in virtually every extensive stage small cell lung cancer patient as upfront therapy, and that's the great majority, most patients, 80% or so, present with an extensive stage, then one would not give a PD-1 agent in the relapse or rescue stage. And so those approvals were essentially are relevant. The situation with Zepzelca is quite different where the single-arm data were quite strong in that second line, both in terms of objective response rate, durability of response and tolerability relative to very poor options in that second-line space. And so we think it's a very different situation. We do think the activity in second line is encouraging enough to try to move that into frontline therapy. And even though there has been advances in frontline therapy, such as the addition of -- or namely the addition of PD-L1 antagonist, the prognosis there is still very poor with more than 50% -- or about 50% of patients dying before just after a year. And so we think adding Zepzelca in that frontline setting could be really important to extend that period of progression-free survival and ultimately potentially overall survival. It will allow us to bring the therapy to more patients because not all frontline patients even make it to second line. And we know that, that initial period of response is when patients really feel the best after their diagnosis and to extend that would have -- potentially have a really important impact on quality and life as well. So we're excited to initiate that frontline add-on study this year.

Got it. And I have a question here on the line. I'm going to read this out. So the recent Phase IV trial for lurbinectedin published in clinical trials is confirmatory for full approval of lurbinectedin, that's a question mark.

Yes. I can clarify that.

In this case, could it be possible to get full approval this year?

Yes. So that trial, the Phase IV trial, which we call an observational study, was put in place long before -- or at least was planned long before we knew the results of ATLANTIS or spoke to the FDA about the path to confirmatory approval. It's really intended to be a real-world observational study where patients who are prescribed by their doctor, Zepzelca, we collect useful information around the benefit, I would say, in certain subgroups of patients in the second line. So it wasn't designed to primarily be a confirmatory trial, although it will generate data, I think, are useful overall. We -- recently, we and PharmaMar had a very constructive meeting with the FDA around our initial thoughts on plans for confirmatory trials, and we're working through that, and we'll very shortly be able to share details of the path forward there.

Got it. So is that sort of a second -- is that third quarter or more of a later in the year update that we should be expecting?

We haven't said that, but the meeting occurred very recently. And so again, it was very constructive. We have real clarity on what the FDA expects there, and we think it's a clear path to initiating a program that would confirm the approval in second line. And so we're just putting together the details of that plan. And as soon as we have it, we'd be happy to share it.

Understood. So switching gears here a little bit in terms of capital deployment broadly. I know delevering is priority #1. But as you're -- and that seems to be a fairly quick turnaround there. But -- so how are you thinking about outside of delevering, whether deploying capital? I mean, are they -- are you still looking at other opportunities to tuck-in or to add-on or bigger opportunities or share repurchases? What's -- how do you prioritize between those two?

Yes. I'll be happy to jump in on that, Esther. So clearly, we'll continue to focus on investing behind our important launches. 3 launches last year, 2 planned launches this year. And now, of course, we want to continue to ensure that Epidiolex continues on the trajectory that it's on. So from a capital allocation perspective, we'll continue to invest behind the launches. We'll be investing behind the pipeline. We've talked about 458 as well as nabiximols. We have a number of opportunities there. But then, yes, of course, we are confident, highly confident in the net leverage ratio that we put out for the end of next year, getting from around 5x at close to below 3.5x by the end of next year, which is enabled by the strong cash flow generated by our business. And in terms of -- you'd asked about share repurchases, we'll continue to be opportunistic. As we see opportunities in the business, as we see opportunities to continue to bring in either licensing transactions to augment the pipeline, or post-deleveraging opportunities from an M&A perspective, we'll continue to evaluate those. The beauty is that the underlying cash flow and strength of our business gives us a lot of options. If we think share repurchases are the right allocation of capital strategy, we'll continue to pursue that. We do have a little over $400 million left in our share repurchase program. But right now, with the opportunities in our business, we're putting that capital to work within the business.

Understood. And in terms of when you sort of start -- you referred to some licensing and other business development opportunities. And taking that sort of in the context of your current portfolio, how would you decide between sort of oncology versus CNS? Where do you see more near-term opportunities, whether that be from the perspective of valuation or just your kind of strategic overlap?

Yes. Well, obviously, we see opportunities in both of those areas. And I would say, if you just look at some of our historical transactions, in addition to getting the GW acquisition done, which provides us great opportunity to optimize that pipeline, as Justin described, the nabiximols, we think that is a nice complement to some of the programs that we've already brought in. But we were talking about Zepzelca just a few moments ago. That's a great example of $200 million upfront, taking cash on our balance sheet to bring in a near on-market product that now even at the end of the first quarter is already annualizing after 3 quarters on the market, over $200 million in sales. So we'll continue to look at opportunities like that to augment either the oncology or the neuroscience portfolio. And within our guidance for that net leverage of getting below 3.5x, we've given ourselves the flexibility to be able to bring in additional licensing opportunities within that leverage guidance. So we'll be opportunistic to look at what is the right fit for our commercial portfolio, what's the right fit for our development expertise and look broadly across early and mid to late stage.

Got it. We're just about coming up on time, but I have a question here, which I'm going to reframe this question a little bit. So the listener is asking in terms of Epidiolex, what are -- how do you think about the risk of a potential, I guess, another company filing against the patent for Epidiolex? And can you frame the risk for Jazz and GW together? I guess it's a theoretical scenario someone's trying to play out.

Yes. I'll let Justin weigh in on this.

Right. Sure. I mean I think the high-level answer is we -- I mean that there is a web of IP surrounding this product. So I've mentioned earlier, 16 patents granted already more on their way, this composition patent that I mentioned earlier, formulation. So the whole point and thinking behind the strategy is to have a web of IP. And so I think from that perspective, we've done a good job of covering all the basis for this. I'm not sure if that fully answers the question, but I mean, that is essentially -- I think it's pretty clear to us that we've taken a long look at how to do the best we can to protect this product and are very comfortable with the plan we've put in place.

Understood. And I guess one last question on that -- on GW. As you're sort of looking at the CapEx or the infrastructure, Bruce, do you anticipate any additional changes in your manufacturing spend or CapEx related to GW? Or do you feel the infrastructure that was in place is sufficient to grow the business as you see fit?

Well, the great news about the combined business right now is we've got a number of products that are growing nicely, and we've got other products progressing through the pipeline. And so how to ensure a robust product supply across the whole portfolio, which has always been a combination of our own facilities and use of contract manufacturers, will continue to be a focus. As Xyrem became a bigger product for Jazz historically, we built a greenfield production site in the middle of Ireland in Athlone, which is FDA-approved and now supplying a lot of our needs. That made sure we had a more robust supply chain. We'll continue to do that kind of analysis to make sure across the products, including the GW portfolio, we continue to put in place sufficient, high-quality manufacturing to meet our needs. But when you look at the overall cash flow picture of the company, as Renee describes it, I would not consider those capital needs to be significant.

Understood. Great. Well, we're just about out of time. Any last thoughts before we say thank you, and goodbye?

Yes. I'll just conclude by thanking everyone for listening in and just remarking that this is an unusually exciting time for Jazz, given the product launches, given the pipeline progress and now given bringing the 2 strong organizations together in Jazz and GW. So as we look forward across the balance of the year with some upcoming catalysts, including a potential approval and launch of JZP-458, hopefully, an upcoming approval and launch of IH, continued progress on the Epidiolex rollout, some Phase II programs for essential tremor, PTSD, progress with nabiximols, we do think it's a really exciting time for the company, and we think we've got the right team to execute on that strategy.

Great. Thank you, Bruce and Justin and Robert and Renee. Appreciate your time, and we look forward to having you on our platform again.

All right. Thank you.

Thank you.

Thank you. Bye-bye.