Thank you, everybody, for the 2023 RBC Global Healthcare Conference. My name is Greg Renza, one of the Senior Biotech Equity Research Analysts here at RBC, and we're pleased to be joined by Jazz Pharmaceuticals and with a robust team today, led by the Chairman and CEO, Bruce Cozadd. Bruce, Rob, P.J., it's great to have you. Bruce, I'll turn it over to you for an intro, not just to Jazz, but also to the great team we have here today. Yeah, so I'm Bruce Cozadd, Chairman and CEO, Founder of Jazz Pharmaceuticals. Good to see you all today. Pleased to be joined by some fellow members of the management team. It doesn't look like our management team is half diverse because we just brought the guys this time, but I want you to know more than half of our management team is diverse by gender, color, or LGBTQ status. We've got with us today, starting next to me, P.J. Honerkamp. P.J. runs our U.S. Sleep business. Rob Iannone runs R&D for Jazz, and Abizar Gaslightwala runs U.S. Oncology. So hopefully we'll get some questions on all of the above and can participate in the answers. Let me start out with some intro remarks. First, the unexciting part. I will make forward-looking statements. SEC filings for risk factors. If I refer to non-GAAP numbers, there's always a reconciliation to GAAP on our website. And if I refer to guidance, I'm referring to guidance as we re-gave it just a week ago on May 10th. Jazz just came off our first quarter earnings call. I'm happy to say our execution during the first quarter of the year was exactly what we hoped it would be. That makes us confident in our 2023 guidance, but importantly, also makes us confident about hitting Vision 2025. I'll walk through the three pieces of that. On the revenue side, important to see continued growth of Xywav. Xywav was up about 49% year-over-year. We added more narcolepsy patients in the first quarter, 500 more narcolepsy patients, despite the availability of an AG to Xyrem during the quarter for the first time. We also see strong growth in idiopathic hypersomnia, where we left the quarter with 2,000 patients, and lots of signs point to continued momentum and growth for our oxybate business. Also, strong Epidiolex growth, 20% year-over-year. We're seeing good growth in the U.S. We're early in the launch in Europe, where we just launched in the fifth of our five major European markets, France, at the end of the year. Lots of reasons to expect growth to continue with Epidiolex. And then on the oncology side, we're seeing great growth in Rylaze and Zepzelca. Rylaze up over 50% year-over-year, and we think we're on track for the midpoint of our guidance, which is $1 billion in oncology sales in 2023. On the pipeline side, we've never had a stronger pipeline at Jazz, and I'm particularly excited about some near-term, long-term, or near-term value-creating readouts of late-stage programs, in particular JZP150 and PTSD at the end of this year, and then early or first part of next year, JZP385 for essential tremor, as well as GEA with zanidatamab. We've also got a presentation coming up at ASCO on June 2nd, an oral presentation with good BTC data. We also have a frontline trial combination therapy of Zepzelca with Tecentriq that should finish enrollment this year. Excited about lots of other things in the pipeline. I'm not sure I mentioned all of Rob's favorites, but those are a couple of the upcoming late-stage readouts. The third piece of our Vision 2025 is really about margin expansion. It's about continued investment, and I'm happy to say cash flow was excellent in the first quarter, $320 million, up strongly from last year. We've delevered rapidly since the GW deal down to 2.6x leverage from what was 4.9x just two years ago. We've got $1.2 billion in cash and an undrawn revolver of $500 million. So when we think about continuing to grow our portfolio, both commercial and R&D, through corporate development, continuing to invest in our commercial brands, continuing to invest in R&D, we can do so from a real position of strength. So Greg, happy to open it up for questions, but great first quarter, on track for 2023 and Vision 2025. That's great, Bruce. Thanks for the intro and a lot to certainly unpack. And as you alluded to, just being fresh from the quarter just over a week ago, and as you're tracking to Vision 2025, just on a high level, how are you seeing that underlying demand across the multiple areas of your franchise? And as you said you continue that commitment to grow, volume and patient demand needs to be there. So maybe break that down. Yeah, and to be clear, our growth is all coming from volume growth. We're really seeing strong demand across the portfolio. And maybe I could ask P.J. to highlight oxybate a little bit. I know we've got a lot of questions on oxybate given the evolving landscape, and maybe Abizar could comment on Rylaze a little bit. Yeah, I think we continue to see tremendous momentum with Xywav. Bruce mentioned we had over 500 patients added in narcolepsy, over 250 patients added in idiopathic hypersomnia. Most recent market research shows that physicians, with respect to IH, 70% of them intend to prescribe more Xywav in the next six months. So we're really seeing that momentum. We've had two and a half years to really establish our story that low sodium is the oxybate of choice for patients with narcolepsy. In the last year, really establishing, transitioning the IH market really from a story about a symptom of idiopathic hypersomnia with excessive daytime sleepiness to really about the treatment of idiopathic hypersomnia, which we were approved for because I think oxybate is uniquely situated. Rylaze is uniquely situated to address some of these other symptoms that the wake-promoting agents and traditional stimulants haven't been able to address in the past. Abizar? Yeah, Rylaze is very happy with where we are, in particular that over 50% growth in net sales was driven by demand, and we see that both in the pediatric segment as well as the AYA, Y oung Adult segment, and again, the recent indication approval for Monday, Wednesday, Friday dosing late last year continues to drive our uptake in both those segments. We're really happy there, and maybe just as you're commenting on demand across the franchise, maybe a bit on Epidiolex as well. Yeah, so Epidiolex, we saw 20% first quarter over first quarter growth. We're seeing good growth that we think comes from a couple of things. Number one, physicians are really appreciating the data on the efficacy in seizure reductions of Epidiolex combined with clobazam. So we see data that these two agents together give 60% seizure reduction in Dravet and LGS and about 50% in TSC. That kind of synergistic efficacy is not generally seen with other agents, even in combination. And I think it's compelling to clinicians to think about if they're not already using Epidiolex in many or all of their clobazam patients. And that's, of course, one of the most commonly used treatments to consider adding Epidiolex. We're also hearing people are resonating with our beyond seizure data. So in addition to seizure benefits, we often hear reports from caregivers and clinicians of improvements in behavioral, cognition, communication, other endpoints. And we're seeing that both from caregiver survey data that we've presented, ongoing clinical studies. We believe that's important in making a treatment choice. We see in our surveys that physicians are using Epidiolex earlier in the treatment algorithm, which is a good sign for their confidence. We think there's growth opportunity too on the adult side. Our heavy focus has been on the pediatric side, but there's good adult use of Epidiolex as well. I mentioned the ongoing launches in Europe. In some cases, we're entering new countries for the first time. In some cases, we're launching yet another indication, so launching the TSC indication after the other two. But we're earlier in that growth curve, so a lot of opportunity there as well. And then I'll just point out our phase III trial in Japan is enrolling well. That's in all three indications we have in the U.S. and Europe. Great. A good overview of three key products here, and maybe spinning back to oxybate, and as you alluded to with respect to an AG launch, which we and you have all been preparing for, what are you seeing in terms of those behaviors of physicians, of the patients, maybe a proportion of those patients who have switched? How are you quantifying that, and maybe just that receptivity in the marketplace to an AG. Yeah, I would say that the launch is going as expected. We've been competing with high sodium oxybate in the form of Xyrem for the two years of the Xywav launch. And I would say the AG market dynamics are much more similar to a branded market dynamics rather than what you would see in a typical generics market. So we're seeing utilization, but more importantly, we're seeing growth of Xywav through that utilization. Xywav continuing to grow. Anecdotally, in some cases, we have seen some patients who transition to the authorized generic and have to transition back to Xywav because what we provide is more than just what's in the bottle. And I think physicians and patients have come to appreciate the unique services that Jazz provides around this product. When there's the opportunity, they realize they're not going to be getting that, have decided to revisit that discussion they had with the patient and come back to Rylaze in some instances. That's great. Certainly more than price. We're talking about the differentiated services that can't be overlooked here. That's really helpful. And then just on price, what are the thoughts on pricing of the three AG followers coming into the market? How could that impact the dynamics, at least on that medium to longer term? Yeah, I'll point out that there are three volume-limited AGs that have the right to enter starting July 1st. But in all three cases, their volume is significantly limited. We don't make pricing decisions, can't comment on how other companies will price the products, but I will say the usual dynamic of lowering price to gain volume probably won't get them very far given those volume limitations. So as P.J. characterized the existing market more as almost like a different brand, I'm not sure that's going to change dramatically in the second half of the year. With respect to branded competition, we do have one entering the market on once nightly. Knowing the sleep space exceedingly well, what's the feedback you're hearing there on that profile for competition? One nightly, higher sodium concentration. There's an angle with the Sodium Matters campaign as well. Maybe help us understand the appreciation of low sodium as it relates to that, and also just the trade-offs of the administration. Yeah, I mean, our focus has been and will continue to be on the low sodium market, remembering that the sodium reduction as you move from Xyrem to Xywav of 92% results in about a gram and a half less sodium per night in a chronic condition for patients known to be at high cardiovascular risk. That's like eating five orders of fast food French fries, five large orders of fast food French fries every night for the rest of your life. So that sodium difference is known to matter. FDA deemed Xywav to be clinically superior to Xyrem because of that sodium reduction and pointed it out as should lead to less cardiovascular morbidity. Importantly, the FT218 product has exactly the same sodium as Xyrem. And so all those comparisons would be the same in terms of it being a safer product to be on Xywav. So with our focus on Xywav, how the market, the high sodium market, splits up among branded Xyrem, among AG Xyrem, a new high sodium, different dosing, fixed dosing product coming to market, we'll wait to see. But our strategic focus remains on providing what we believe will be the oxybate of choice, which is Xywav. Maybe just drilling down on oncology. You mentioned Rylaze thus far. Maybe just on Zepzelca, just the performance there in small cell lung cancer, how that's tracked relative to your expectations. What is that effort to expand into first line? How is that progressing? Yeah, maybe Abizar, you can start with second line, and then Rob, jump in a little bit with first line. Yeah, sure. Great. So we continue to be the number one agent in small cell second-line agents for new patient starts. We're really happy with the progress of building where we've been since the launch. We continue to take share from other older agents like topotecan, which has been used historically. Zepzelca has been this new entrant, and we've done a great job, as well as monotherapy, immunotherapy that's used frontline that often is continued as patients relapse. So we continue to educate. We know that physicians see small cell lung cancer on a kind of orphan-like basis. So we have to continue to remind them about us. And we're really happy with where we are. We incrementally gain more and more share as we continue to message. We're really excited about the work that Rob and his team have done in the frontline. I'll let you take it from there. Yeah, thanks, Abizar. So we have an opportunity and a trial that's expected to complete enrollment this year in frontline in collaboration with Genentech. It's Zepzelca add-on therapy to four cycles of chemotherapy and atezolizumab. The standard is to continue atezolizumab and stop the chemotherapy. So this is a switch maintenance trial where at the end of that standard chemo, patients either get Zepzelca, randomized to Zepzelca, or no additional therapy on top of atezo. So it's really comparison against nothing in a population of patients we know are sensitive to Zepzelca because they would have not progressed on their cisplatin. So accessing more patients with a longer duration of therapy, we think. Fantastic. Maybe just keeping on the oncology theme. I know, Rob, you have a lot to talk about, but just maybe teeing up a brief zanidatamab, and while we're all interested in how that strategy, the licensing, and the design of this deal fits into Vision 2025, as you mentioned, we do have some ASCO presentation coming up, and maybe we can just focus there to learn about how to set expectations there. We've got a KOL webcast, as has been mentioned, and maybe segueing once we cover that just on the regulatory path going forward. Yeah, and I'll just say that when we announced the deal, we announced our excitement about the two lead indications, which are BTC and GEA. We've had positive data readouts in both of those even since we signed the deal late last year. So Rob can comment on those. But I'd also like Rob to talk about where we can go beyond BTC and GEA. Sure. So we announced top-line results for biliary tract cancer at the end of last year. That was more than 80 patients in what was set up to be a pivotal trial. There was a separate cohort of 20-some of preliminary data. So together, there's more than 100 patients. We said at that time that the response rates were over 40%, and the Kaplan-Meier estimates for duration of response 12.9 months, which is really much, much improved over what you'd expect. Chemotherapy in that setting, at most 10% response rate and pretty transient responses. The presentation on Friday at ASCO will go into greater detail there, not only on the efficacy, showing some PFS data, but also all the details of patient characteristics and the safety that will give you a sense of what will go into the BLA with the FDA to support approval. And we do think that this package will support approval, allows us to get onto the market in the near term, even while we're awaiting a data readout from our front-line gastric trial, which is obviously a bigger population. And as Bruce mentioned, we are now anticipating that we'll soon be on the market with what we believe is a truly de-risked asset. We think this drug works wherever HER2 is amplified. We think it can work after HER2, after failure of prior HER2 therapies. So we are actively looking at where else can we go with this drug. And we certainly think breast cancer is a place that we want to be with this. We've already initiated a collaborative trial with I-SPY as a way to focus on early-stage breast cancer. But even beyond breast cancer, there are data we have in other tumor types, such as colorectal cancer, etc., where we will be exploring the possibility of additional studies. And contribution with Vision 2025, I understand that's a guiding compass for deals like this. But as you talk about potential revenues during this decade, how would we think about that? Yeah, when we announced Vision 2025, we said that we expected about 90%, $4.5 billion of our $5 billion target to come from existing products. So oxybate, Epidiolex, and then our oncology portfolio. We said the remaining 10%, about $500 million, could come either from things that emerge from our pipeline during this period, plus additional corporate development activity. So zanidatamab could certainly contribute revenue in that 2025 timeframe. We do expect to continue to be busy on the corporate development side. That's been a pillar of our strategy for some time. And with our improved financial flexibility and the state of the markets now, we continue to believe it's a good time to be a buyer of innovation, as we have been many times over the past 10 to 12 years. Expect us to be busy on the corp dev side in 2023 and going forward to bring in additional commercial and R&D programs that could contribute to Vision 2025, but also revenue growth beyond 2025. Certainly, within your pipeline, there are some readouts that are setting up over the next year, which could or could not guide the view of the external world and how acquisitive or how active you want to be strategically. Maybe just cover some of those, starting with JZP150 in PTSD, phase II coming this year. Just walk us through maybe the benchmarks, the level of benefit over placebo, just the design of that trial and what we should be thinking about. Happy to. So first of all, we think we have a potentially best-in-class FAAH inhibitor. There are others in development. This has the characteristic of being an irreversible inhibitor, very potent drug. We're evaluating 0.3 mg and 4 mg in a randomized, placebo controlled, I think, well-powered phase II study with a standard endpoint, TETRAS. So we think we're well-powered to what would be a meaningful clinical effect that will help us make a decision to go to the next stage. On essential tremor with suvecaltamide, certainly it looks like it's in an important first half of 2024. Top-line phase II, maybe walk us through just the essential tremor market and also the differentiation. I think you lost your microphone there, so you might grab that while we're talking. So essential tremor is the most common movement disorder. By the way, if any of you are watching my right hand shake, I have tremor in my right hand. My My left hand shakes, I'm nervous. If my right hand shakes, it's tremor. Most common movement disorder in the world, and there has not been a new effective treatment, never an effective treatment, I probably should say, in the past 50 years. So the need is high. We think what we're evaluating in our clinical trial, where our endpoint is based on activities of daily living, not just amplitude of motion, but can patients, can ET sufferers, button and unbutton clothes, can they drink a glass of water, can they eat, can they apply makeup? These are the things patients care about. While that was not the primary endpoint of the phase II-A trial, it is the endpoint in our ongoing phase II-B trial. Rob, maybe you could talk about the trial design. Yeah. So Greg, this one's actually a little further along than the 150 study. We do have prior data, concept data from a study called T-CALM before we acquired the asset. Learned a lot from that study in terms of how to refine the endpoint, come to an agreement with the FDA around the TETRAS scale and how that might be modified. We reformulated the drug so that it's once a day. And we also think that that gives a better PK profile in order to optimize the therapeutic index. The drug is titratable, so we'll titrate up, which helps avoid some of the side effects that can occur if you were just to go to a high dose. The study is well-powered. It has three dose levels, 10 mg, 20 mg, and 30 mg, so really allow us to fully explore the effective dose range. Dosing is for 12 weeks so that we really can give an opportunity for all patients to respond and then also assess the persistence of that response. And this is where the drug that we think is differentiated in that we refer to it as being state-dependent, tends to be more active on open or active calcium ion channels versus those that are in the resting state. And that overactivity, over-excitability is what differentiates tremor from non-tremor. And so we think that it's differentiated, and this will be certainly a pivotal trial, the first of the pivotal program. Great. Great. Just out of time, Bruce, maybe over to you for some closing comments. Yeah. Well, just thanks for your interest in Jazz. And again, with the company hitting on revenue growth, bottom-line income growth, financial strength, being poised to do more corp dev, readouts, some interesting R&D programs over the next year, great time to be relooking at Jazz if you haven't been keeping up with our recent progress. Great. Gentlemen, thank you for joining us. Yeah. Thanks, Greg. Thank you. Thank you.