Good day, and thank you for standing by. Welcome to the Q1 2023 Jazz Pharmaceuticals Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Andrea Flynn, Vice President and Head of Investor Relations. Please go ahead. Thank you, operator, good afternoon, everyone. Today, Jazz Pharmaceuticals reported its first quarter 2023 financial results. The slide presentation accompanying this webcast is available on the investors section of our website. Investors may also refer to the press release we issued earlier today, which is also posted to our website. On the call today are Bruce Cozadd, Chairman and Chief Executive Officer, Renée Galá, Executive Vice President and Chief Financial Officer, Dan Swisher, President and Chief Operating Officer, and Rob Iannone, Executive Vice President, Global Head of R&D. Kim Sablich, Executive Vice President and General Manager, United States, will join the team for Q&A. On slide two, I'd like to remind you that today's webcast includes forward-looking statements such as those related to our future financial and operating results, growth potential and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events, performance and results to differ materially from those contained in these forward-looking statements. We encourage you to review the statements contained in today's press release, in our slide deck, and in our latest SEC disclosure document, which identifies certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in these forward-looking statements made on today's webcast. We undertake no duty or obligation to update our forward-looking statements. Turning to slide three. On this webcast, we'll discuss non-GAAP financial measures. Descriptions of these non-GAAP financial measures and reconciliation of GAAP to non-GAAP financial measures are included in today's press release and the slide presentation available on the investors section of our website. I'll now turn the call over to Bruce. Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today. I'll start on slide 5. In the first quarter of 2023, we once again delivered strong commercial results, continued to advance our pipeline and built on our record of operational excellence. Our results for the quarter underscore the durability and growth of our core commercial products and our enhanced R&D capabilities. On the commercial front, our focus on execution continues to drive key product sales, headlined by the strong performance of low-sodium Xywav. We're especially pleased that physicians and patients continued to choose Xywav even as a high-sodium oxybate authorized generic, or AG, entered the market. We continue to expect that Xywav will both grow and remain the oxybate of choice in 2023, even with the availability of high-sodium oxybate AG and branded fixed-dose high-sodium oxybate. Xywav active patients grew in both narcolepsy and idiopathic hypersomnia, or IH, in the first quarter. Our efforts to educate prescribers and patients about the benefits of Xywav remain effective and are resonating in the market. Xywav is now annualizing at more than $1 billion in net product sales, making it our largest product by net sales. As outlined in Vision 2025, we anticipate our oxybate franchise will generate $2 billion in revenue in 2025. We saw significant year-over-year growth in product sales for Epidiolex. Importantly, outside the U.S., we have now launched in all five key European markets. Demand for Rylaze remains strong in the U.S., with potential European approval later this year. Zepzelca remains the treatment of choice in second-line small cell lung cancer. Longer term, our ongoing efforts to explore Zepzelca in several new patient populations, including first-line small cell lung cancer, may open up opportunities for meaningful growth. Moving to R&D, we continue to advance multiple investigational therapies in our pipeline and expect to have at least three late-stage readouts by the end of 2024, including JZP-150 in post-traumatic stress disorder, suvecaltamide in essential tremor, and Zanidatamab in first-line gastroesophageal adenocarcinoma, or GEA. On the operational side, our strong execution drove significant top and bottom-line growth in the first quarter compared to the prior year. We have a business that continues to generate meaningful cash flow. In line with our disciplined capital allocation, we continue to invest in areas of our business that we believe will drive the most benefit for patients and value for shareholders, including a robust pipeline with more than 20 novel candidates across neuroscience, oncology and cannabinoids. We are reaffirming our 2023 guidance, which Renée will discuss in more detail. Turning to slide six. Vision 2025 remains our strategic North Star, which we believe will deliver sustainable growth and enhanced value. We have made meaningful progress in all three areas of Vision 2025 and believe we are well-positioned to achieve these important milestones, each of which are critical to our transformation into a high-growth global biopharma leader. I'll now turn the call over to Dan to review our commercial performance. After which, Rob will share an update on our R&D progress. Renée will provide a financial overview, and then we'll open the call to Q&A. Dan? Thanks, Bruce. I'm excited to share the continued progress across our commercial portfolio. I'll begin on slide eight with neuroscience and our oxybate franchise. We remain confident in the durability of our oxybate franchise and have established low sodium Xywav as the oxybate treatment of choice. Xywav became our largest product by net product sales as of the Q4 of 2022 and is annualizing at more than $1 billion as a result of continued adoption of both narcolepsy and IH. In the first quarter, average active Jazz oxybate patients increased to approximately 17,400, representing growth of approximately 5%, and total oxybate revenues, including royalties from high sodium oxybate AG, grew by approximately 6% compared to the year prior. In narcolepsy, we continue to focus on educating patients and prescribers on the benefits of reducing sodium intake, and this message is resonating. We were very pleased with performance in the first quarter and exited 1Q 2023 with approximately 9,050 narcolepsy patients taking Xywav, an increase of approximately 500 patients from the fourth quarter of 2022. In IH, we see continued growth of new prescribers, and exiting the first quarter, there were approximately 2,000 IH patients taking Xywav. IH is a 24-hour sleep disorder, and Xywav is the first and only treatment approved by FDA to treat the full condition of IH. Importantly, it has been studied across the multiple symptoms of IH. Our field force remains focused on educating prescribers on the importance of proper diagnosis and identifying appropriate patients for Xywav therapy. A recent Jazz survey of sleep specialists indicate that approximately 70% anticipate increasing their prescribing over the next six months. Slide nine highlights the compelling low-sodium health benefits we are sharing with healthcare professionals and patients. Narcolepsy is a debilitating chronic condition, and we are focused on education around the lifelong burden of high-sodium intake for narcolepsy patients who live with an increased risk of cardiovascular comorbidities. Xywav is the only approved low-sodium oxybate and has 92% less sodium than high-sodium oxybates. The American Heart Association recommends a maximum of 1,500 milligrams of sodium per day. Xywav has 100-140 milligrams, a reduction of 1,000-1,500 milligrams of sodium per day compared to high-sodium oxybates. This has significant potential health benefits, including lower blood pressure and improved cardiovascular health. To add to the literature on sodium impact, we presented data at this year's American Academy of Neurology meeting that showed narcolepsy patients treated with high sodium oxybate had a higher risk of new-onset hypertension diagnosis or antihypertensive medication initiation within 180 days of starting therapy when compared to a matched control group of narcolepsy patients not being treated with high sodium oxybate. In fact, the risk of those taking high sodium oxybate was approximately twice that of the control group. With regards to oxybate competition, a high sodium oxybate AG was launched in January, and we anticipate additional AG and branded fixed-dose high sodium oxybate competition in the coming months. With competition now in the marketplace, I'll share a few key takeaways based on our experience in the first quarter. First, we continue to build on the successful launch of Xywav. It remains the only low sodium oxybate available to patients. We expect it to be the only oxybate indicated for IH for the foreseeable future. Second, we expect that Xywav will both grow and remain the oxybate of choice in 2023, even with the availability of high sodium oxybates. I'll highlight that the large majority of narcolepsy patients beginning oxybate therapy in the first quarter chose Xywav over high sodium oxybate, and we expect to continue to see patients transition from both Xyrem and high sodium oxybate AG to Xywav. Third, we believe that the majority of patients and healthcare providers will continue to prioritize long-term health when evaluating oxybate therapy. FDA continues to recognize seven years of orphan drug exclusivity through July 2027 for Xywav and narcolepsy. FDA has also recognized the difference in sodium content between Xywav and Lumryz, a fixed-dose high sodium oxybate, is likely to be clinically meaningful in all patients with narcolepsy and that Xywav is safer than Lumryz in all such patients. I'll also note that branded fixed-dose high sodium oxybate has the same sodium content as Xyrem and the high sodium oxybate. Xywav is the only approved oxybate therapy that does not carry a warning and precaution related to high sodium intake. All of these factors give us confidence that Xywav is a durable product that we believe will continue to be a core growth driver for Jazz. Moving to slide 10, we are pleased with the continued growth of Epidiolex, with net product sales in first quarter 2023 growing by 20% year-over-year to $189 million. Growth was driven by underlying demand in the U.S. and expansion to new markets outside the U.S. We are seeing increasing use of Epidiolex earlier in the treatment algorithm. We continue to see seasonality in ordering patterns in the U.S. with a combination of a more gradual build in inventory over the second half of the year, and insurance plan resets with payers impacting the first quarter, not dissimilar to what we've seen historically with oxybate. Turning to slide 11, we are building on our solid foundation to capitalize on additional opportunities we see to drive Epidiolex growth. We've recently launched a number of initiatives, including educational efforts focused on optimal dosing and caregiver-reported outcomes of Epidiolex treatment, including seizure, behavior, and cognition data from the BECOME Survey. These new initiatives are complemented by the compelling data presented last year for use of Epidiolex in combination with clobazam. Our commercial team also has an enhanced focus on further penetration into the adult setting. We remain focused on growing Epidiolex outside the U.S. We have now launched in all five key European markets, and while it's early, we are very encouraged by uptake in those markets, with pricing and access remaining strong. Moving to slide 12, net product sales for Rylaze were $86 million for the first quarter, a 58% increase year-over-year. Based on the availability of Rylaze, healthcare providers have indicated they are returning to best clinical practice and switching therapy at the first signs of hypersensitivity. The approval of Monday, Wednesday, Friday dosing allows for a dosing schedule that is more in line with preferred clinical practice. Rylaze is maintaining strong momentum in pediatric oncology protocols and has been almost universally adopted in this setting. We are also encouraged to see that there is an increase in use of Rylaze in the treatment of adolescents and young adults or the AYA market, which is an area of increased emphasis for us in 2023. Outside of the U.S., we submitted a marketing authorization application to the European Medicines Agency in May 2022. We are also continuing to evaluate patient needs in other geographies. Slide 13 highlights that we have rapidly established Zepzelca as the treatment of choice in second-line small cell lung cancer. Zepzelca net product sales increased 13% to $67 million in Q1 2023 compared to the same period in 2022. Rob will discuss our development plans for Zepzelca, which also includes trials in first-line small cell lung cancer and other tumor types, providing the opportunity for meaningful future growth in new patient populations. Now I'll turn the call over to Rob for an update on our pipeline and upcoming milestones. Rob? Thanks, Dan. Starting on slide 15, we've detailed key clinical programs in our pipeline. Our team is energized by the advances we've made. We're looking forward to late-stage data readouts from at least three clinical stage programs in 2023 and 2024. JZP-150 in PTSD, suvecaltamide in essential tremor, and zanidatamab, or ZANI, in GEA. I'll highlight several programs in more detail shortly. First I want to touch on a few key points as we look across the breadth of the pipeline. Starting with neuroscience, enrollment is ongoing in our phase II PTSD trial for JZP-150, with top-line data expected late this year. We are also advancing trials for suvecaltamide in both essential tremor, or ET, and Parkinson's disease tremor, with top-line data from the ET trial expected in the first half of 2024. In our orexin-2 receptor agonist or JZP-441 phase 1 program, we anticipate initial proof of concept in healthy volunteers this year. JZP-441 has the potential to treat narcolepsy, IH, as well as other sleep disorders. Moving to oncology, zanidatamab is a priority program for us. We are committed to bringing this novel therapy to patients. In late April, we amended our agreement with Zymeworks. We are excited to welcome new colleagues who are focused on zanidatamab at Zymeworks to Jazz. This allows us to benefit from their wealth of knowledge and expertise as we look to bring zanidatamab to the market as rapidly as possible and explore other opportunities beyond BTC and GEA. For Zepzelca, we expect to complete enrollment this year for the ongoing phase III trial to evaluate Zepzelca in combination with Tecentriq in first-line extensive stage small cell lung cancer. Turning to slide 16, I'll discuss zanidatamab in more detail. Zanidatamab is a novel HER2-targeted bispecific antibody with biparatopic binding and the potential to transform the current standard of care in multiple HER2-expressing cancers. As an oncologist, I'm impressed to see the monotherapy activity with zani across multiple HER2-expressing tumor types, including cases resistant to prior HER2 therapies. The most advanced clinical work with zani is in biliary tract cancers, or BTC, and gastroesophageal adenocarcinoma or GEA. These are both cancers with significant unmet need and poor outcomes with current standards of care. As a reminder, last year, we and our partner Zymeworks reported positive top-line results from a pivotal phase II-B trial evaluating zanidatamab as monotherapy in patients with previously treated HER2 amplified and expressing BTC. In the trial, 41% of these patients with BTC achieved an objective response as assessed by blinded independent Central review. By contrast, standard of care chemotherapy in second-line BTC would be expected to have an objective response rate of less than 10%. Currently, there are no HER2-targeted therapies approved for the treatment of BTC, and we are in dialogue with the FDA regarding the potential regulatory path forward for zani in BTC. We're pleased that data from this trial have been accepted as an oral presentation at ASCO this year. For those of you interested in more detail on those data, I hope you will join us for the KOL webcast we are hosting following that presentation. We are also progressing our program in GEA. At the January ASCO GI conference, the first zanidatamab overall survival data were presented from a phase II trial evaluating zanidatamab in combination with chemotherapy in first-line patients with HER2 expressing metastatic GEA. The preliminary results show that the median overall survival had not yet been reached, with an 18 month survival rate of 84%. The overall survival findings in this trial are compelling, given that the historically reported overall survival rate for the currently approved standard of care is a median of 14 months. These results show zanidatamab's potential as a foundational treatment for patients with HER2 positive GEA, we look forward to additional data from the ongoing pivotal phase III GEA trial, expected to read out in 2024, which may support U.S. and global regulatory submissions. Since we acquired zanidatamab, our confidence in this program has only grown based on positive data in both BTC and GEA. While our initial focus is on those two tumor types, we believe zanidatamab has the potential to transform the current standard of care in multiple HER2-expressing cancers. To that end, we're excited that Zani was added to the I-SPY breast cancer platform this year. In addition, we have multiple early-stage trials assessing zanidatamab's clinical potential in a range of tumor types and are actively evaluating opportunities to pursue additional label indications. Turning to slide 17, I'd like to highlight suvecaltamide, which is a highly selective and state-dependent modulator of T-type calcium channels in clinical development for the treatment of essential tremor, or ET, and Parkinson's disease tremor. Top-line data readout for the ET trial is anticipated in the first half of 2024, so I'll focus my comments today on that indication. There is a high unmet need for ET treatment, with no new medicines approved in over 50 years. ET can be highly debilitating, with significant effects on patients' quality of life and activities of daily living, such as eating, drinking, dressing, shaving, and writing, and can lead to substantial impairment on physical functioning. Some patients also experience cognitive deficits, anxiety, social phobia, depression, and sleep disturbances. In the U.S. and key European markets, there are approximately two million diagnosed patients with a prevalence estimated at 11 million. Slide 18 illustrates suvecaltamide's differentiated mechanism of action. While the exact underlying pathophysiology of ET is not clear, there is strong evidence to support the role of T-type calcium channels. T-type calcium channels regulate the balance of calcium ions, acting as a gatekeeper to help ions both enter and leave the cell membrane. In some pathologic states, such as ET, increased activation of these channels leads to excessive rhythmic signaling that prompt tremor. The high selectivity of suvecaltamide for T-type calcium channels make it a promising candidate for the treatment of ET. Importantly, suvecaltamide is differentiated from other T-type calcium channel blockers in development as it is state-dependent, meaning that it targets channels under conditions of hyperexcitability while sparing the form of the channel important for normal neuronal signaling. Slide 19 provides an overview of the suvecaltamide ET phase II-B trial design. Approximately 400 participants with moderate to severe ET will be treated with one of three dose levels of suvecaltamide or placebo for 12 weeks. Based on the results from our prior phase II-A proof of concept trial, known as TCOM, as well as FDA feedback, the primary endpoint being used in this trial is a change from baseline to week 12 on a composite of the Tremor Research Group Essential Tremor Rating Assessment Scale, known as TETRAS. The two composite measure is composed of items from two scales. 11 items from the TETRAS Activity of Daily Living, which includes measures such as feeding with a spoon, hygiene and using keys, and two items from the TETRAS performance scale, which represent handwriting and drawing in an Archimedes spiral, which was depicted on slide 17. We conducted post-hoc analyses on TCOM, which was a four week randomized double-blind placebo-controlled study to better understand the treatment effect with the TETRAS composite endpoint. We believe that our ongoing Phase 2B trial has been optimally designed to use the phase II-A learnings and that an appropriate patient population, primary endpoint, and study duration have been selected to adequately evaluate the safety and efficacy of suvecaltamide across three dose levels. On slide 20, we've highlighted several key aspects of our program exploring JZP-150 for the treatment of PTSD, a psychiatric disorder that affects millions of people. Patients frequently have uncontrolled symptoms that impact their ability to perform activities of daily living and social function. PTSD affects up to 8% of adults during their lifetime and is associated with significant morbidity and mortality. There haven't been any new medicines approved for the treatment of PTSD in over two decades. Current standard of care includes cognitive behavior therapy with SSRIs and SNRIs used as first-line pharmacotherapy treatments. However, response rates to pharmacological treatments rarely exceed 60%, and even fewer patients achieve clinical remission. JZP-150 is a potent, selective, and irreversible inhibitor of fatty acid amide hydrolase, or FAAH. This is a novel mechanism of action to potentially target the underlying pathophysiology and core symptoms of PTSD. We expect top-line data from this trial late this year. Slide 21 provides an overview of our Zepzelca first-line small cell lung cancer program. Small cell lung cancer patients have particularly poor outcomes, with a five-year overall survival rate of less than 10%. Currently, Zepzelca is indicated to treat patients in the second-line setting, but we see a clear mechanistic rationale for Zepzelca to potentially increase the duration of response in the first-line setting as maintenance therapy in combination with the standard of care, which is chemotherapy plus a PD-L1 inhibitor. We have an ongoing first-line trial being run in collaboration with Roche to evaluate Zepzelca in the setting with chemotherapy plus Tecentriq or atezolizumab. The trial design is outlined on the bottom portion of the slide. We expect to complete enrollment by the end of the year. Now I will turn the call over to Renée for a financial update. Renée? Thanks, Rob. I'll start with our top and bottom-line results on slide 23. As a reminder, our full financial results are available in our press release and 10-Q. In the Q1 of 2023, we recorded impressive year-over-year revenue growth of 10%, achieving $893 million in total revenues. This was driven by growth of our key products in both neuroscience and oncology, including year-over-year double-digit growth of Xywav, Epidiolex, and Rylaze. Our disciplined capital allocation and focus on operational excellence drove adjusted net income of $285 million, growing broadly in line with our revenues compared to the same period in 2022. We continue to generate significant cash from our business, recording more than $320 million of cash from operations in the first quarter of 2023, an increase of 53% compared to the first quarter of 2022. With healthy cash flows and a strong balance sheet, we have strategic flexibility to invest in growth drivers within our current business as well as corporate development opportunities. Corporate development is an important component of Vision 2025. We are actively assessing opportunities that we believe will deliver innovation for patients and contribute to building a sustainable business that provides meaningful returns to shareholders. Turning to slide 24. We are reiterating the 2023 revenue guidance we provided in March. We are executing in line with our expectations and are confident in meeting those targets. The guidance reflects our strong performance in the first quarter, our expectations around the durability of our oxybate franchise, and anticipated growth across our key products. Our total revenue guidance range for 2023 is $3.675 billion-$3.875 billion, positioning us for year-over-year total revenue growth. Our 2023 guidance for neuroscience of $2.675 billion-$2.825 billion incorporates expected growth for both Xywav and Epidiolex, as well as the continued decline in Xyrem due to robust Xywav adoption and the introduction of competitive high sodium oxybate. As a reminder, our neuroscience guidance also includes high sodium oxybate AG royalties, which are recognized within total revenues under royalties, not under neuroscience net product sales. Due to the royalty structure within our AG agreement with Hikma, we expect our royalties to be significantly higher in the second half of 2023 relative to the first half. As a reminder, in the first half of 2023, while Hikma maintains exclusive rights to distribute high sodium oxybate AG, the royalty rate paid to Jazz is tiered and wide-ranging, starting at 10% and going all the way to 90% based on the volume of AG units sold as a percentage of total oxybate units, with the total referring to Xywav, Xyrem, and high sodium oxybate AG. During the second half of 2023, the royalty rate to Jazz becomes fixed at a rate where we and Hikma both have substantial economics regardless of the AG volumes. Our oncology guidance reflects expectations of continued double-digit growth for this franchise with a revenue range of $950 million-$1.05 billion, resulting in a midpoint of $1 billion. Continuing on slide 25, our SG&A guidance for 2023 is a reduction compared to 2022. We are tracking through the first quarter as expected. As we noted in our last quarterly update, our R&D guidance of $700 million at the midpoint represents enhanced investment over 2022, reflecting the growth and maturation of our pipeline, as Rob noted earlier in the call. On the bottom line, we expect to continue to deliver strong adjusted net income with 37% growth at the midpoint and a guidance range of $1.24 billion-$1.31 billion. The midpoints of our financial guidance imply an adjusted operating margin of approximately 46% for the year. We'll continue to prioritize commercial, R&D, and corporate development efforts that we believe will deliver the most value, leveraging our cash generation to invest in our business, improve our bottom line and deliver strong shareholder returns. With our strategic investments, expanding product portfolio, R&D progress and focus on operational excellence, we believe we are well-positioned to achieve Vision 2025 and deliver further diversification, sustainable growth and enhanced value to patients and to shareholders. I'd now like to turn the call back to Bruce. Thanks, Renée. I'll conclude our prepared remarks on slide 27. We started 2023 with significant momentum, and I'm pleased to report that we've continued making strong progress in the first quarter of 2023. On the commercial front, we've successfully launched multiple products over the past several years, which are now demonstrating strong and durable performance. Our pipeline is more robust than it's ever been in the company's history, and we have at least three anticipated late-stage data readouts through 2024 that have the potential to continue to diversify and transform our business. We also remain focused on strategic capital allocation. With our strong cash flow, balance sheet and margins, we have the flexibility to make significant investments across commercial, pipeline, and corporate development to drive sustainable growth and enhance value. That concludes our prepared remarks. I'd now like to turn the call over to the operator to open the line for Q&A. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please limit your question to one question only. Thank you. Please stand by while we compile the Q&A roster. Our first question comes from the line of Jessica Fye with J.P. Morgan. Your line is now open. Hey, guys. This is Na Sun on for Jessica Fye. Can you give us some color on how the introduction of the Xyrem AG is playing out versus what your expectations are? Second, what kind of business development is most interesting to you in this current environment? Thank you. All right, well, let's start with the question about the authorized generic, and then, Renée, maybe you can jump in to handle corporate development. You know, the most important thing to say about our first quarter with an AG on the market is that it's played out very much the way we thought it would thus far. We have a new entrant in the high sodium- Category when we are obviously growing Xywav as the only low sodium product, both in narcolepsy and in idiopathic hypersomnia, where it remains the only approved product without an AG generic. The ability to grow in both narcolepsy and idiopathic hypersomnia in the face of the AG generic, I think is consistent with what we had guided to, and you saw us reaffirm our overall guidance for the year based on that first quarter experience. Renée, you want to take corporate development? Sure. Thanks, Bruce. Corporate development continues to be an important priority for us, as I mentioned in our prepared remarks. In terms of the assets we are interested in, we are squarely focused on commercial and near commercial assets as part of our Vision 2025 revenue goals. We think that zanidatamab can certainly contribute to that goal, but it will not fully cover it. We also are looking at pipeline assets. We have a rather robust pipeline right now that we're pushing forward, and we think we can continue to look at bringing in assets that can complement that pipeline. We do believe there are some good opportunities for us to transact across both of those areas. With respect to commercial or near commercial assets, to be clear, we're not going to overpay for assets, nor do we think that we need to in this environment. Sitting here today, there are multiple opportunities we're interested in, and we're quite busy within that team. Just to get a bit more specific in terms of the types of assets, you know, we really tend to focus on areas of great unmet need, where we think we can have a really meaningful impact for patients, where there's an addressable commercial call point that enables us to leverage our expertise, our global footprint, and then create a durable revenue stream for the company. We're largely focused on neuroscience and oncology areas where we currently operate already. Certainly we're also exploring rare and orphan areas outside of those two therapeutic areas, given the vast majority of our current commercial products are currently serving rare or orphan disease populations. There's certainly applicable expertise that we've developed there. We're excited. We think there's a lot of opportunity. We're well-positioned also from a financial perspective to be able to transact. Your next question comes from the line of Marc Goodman with SVB Leerink. Your line is now open. Yes. Hi. Could you give us a little more color on what's going on in the IH market? We know the number of patients that you moved from last quarter to this quarter, but just, you know, some color, anecdotal information, anything you can help us with to understand what's happening behind the scenes. Thanks. Yeah. Marc, let me turn that question over to Kim. Hi. Yes. We are continuing to see the growth in idiopathic hypersomnia is, you know, quite compelling with 2,000 active patients, you know, exiting the first quarter. When you look underneath that, we see that we're continuing to bring new prescribers on board and creating a larger prescriber base, which is great. What we see is that as prescribers get experienced with the product, you know, Dan mentioned in a survey of sleep specialists, 70% of they're indicating that they're going to increase their prescribing of Xywav for IH over the next six months. You know, good indicators of both the experience that they're having to date as well as their intentions in the future. Do keep in mind that, you know, XYWAV remains, you know, the only FDA-approved treatment option for adults with idiopathic hypersomnia, which is a rare multiple symptom sleep disorder, and the only treatment studied across, you know, the multiple symptoms of IH. We're really still just building this kind of nonexistent, you know, market. As a result, we're executing a comprehensive disease education campaign, both for healthcare providers as well as patients across multiple, you know, channels and platforms. You know, our emphasis really is on educating prescribers on the importance of, you know, a proper and solid diagnosis, and identifying the patients that are appropriate for XYWAV, and really about the fact that, you know, XYWAV is approved to treat the full condition of idiopathic hypersomnia, not just the excessive daytime sleepiness that they have been treating for a number of years with off-label, you know, stimulants and wake promoting agents. Really important at the core of that as well, since they've been so focused on the daytime symptom of excessive daytime sleepiness, is reminding them that idiopathic hypersomnia is actually a 24-hour condition and that XYWAV can address, you know, multiple symptoms of idiopathic hypersomnia. You know, an important educational effort there, and we're gaining traction. Patients so far have been reporting that they're quite pleased with the comprehensive and customized support that they're receiving from Jazz during the path to access. Overall, we're feeling really good, remaining very confident in our ability to maximize the potential of Xywav in this, you know, really underserved market. Your next question comes from the line of Jason Gerberry with Bank of America. Your line is now open. Hey, guys. Thanks for taking my questions. Just a question on the step up, the meaningful step up in the Hikma royalty in the second half. Is that driven off of the assumption that the Hikma AG volumes will step up in a big way and thus their sales? Or is it more just that the royalty rate spikes up in the second half? Or is it just sort of an accounting convention where you're realizing revenue and it may not perfectly align with the period which is captured? Just on the once nightly oxybate, would you expect that to have to be stepped through the AG generic, just, you know, payers historical reluctance to pay for convenience? Thanks. Yeah. On the first part of the question, Jason, it's pretty straightforward. The, the emphasis we're trying to put there is really that the royalty rate is expected to be meaningfully higher in the second half of the year. It's not really a timing or accounting thing. You know, Hikma has been adding patients over time, so they probably have more patients at the end of a period than at the beginning of a period. That will contribute, too. The royalty rate is meaningfully different. On the payer side, in the sort of high oxybate space and how they might handle that, Kim, maybe I'll come to you. Sure. You know, we started out the year, we continue to experience greater than 90% of patients, commercial patients having payer coverage, formulary coverage for XYWAV. We anticipate that to continue. You know, we've been educating payers for some time now about the importance of reducing sodium. We do believe that payers are generally understanding the importance of that reduction. They're seeing the fact that, you know, oxybate, XYWAV is the oxybate market leader with more than half of all oxybate patients on XYWAV and the fact that we've continued to grow this market-leading position over the high sodium oxybate. you know, we anticipate that as other high sodium oxybate, you know, including the, high sodium AG oxybate are added to formularies, that we expect XYWAV to maintain, you know, broad commercial coverage. Your next question comes from the line of Joseph Thome with TD Cowen. Your line is now open. Hi there. Good afternoon. Thank you for taking my question. Maybe one on the pipeline for JZP-150 and PTSD, since we're gonna see those data this year. Maybe what sort of change in the CAPS-5 scale do you think is clinically meaningful or would support additional investment in this program? Placebo response rates are, they can be historically pretty variable in neuropsych indications. Is there anything that you can do in the conduct of the phase II to try and minimize placebo response? Thanks. Sure. I'd be happy to. Yeah. Rob, over to you on that one. Thanks, Bruce. Happy to take the question. On the first part, we haven't said exactly what we think would be clinically meaningful, but we certainly had discussions with FDA and key experts, and we feel that the study is well powered with the two dose levels that we've included. To your point, it's a well-controlled design with placebo. We certainly think the level of severity in the patients that we're recruiting and the well-established endpoint will allow us to differentiate from any placebo effect that you might see in that particular population is pretty severe upon study entry. Your next question comes from the line of Brandon Folkes with Cantor Fitzgerald. Your line is now open. Hi. Thanks for taking my question. Maybe just following on from an earlier question about the IH market. Can you maybe just elaborate a little bit on the willingness you're seeing in the field of prescribers to use a sleep-promoting agent for the IH patient, especially those patients with heavy sleep inertia? Are you seeing prescribers initially maybe try this in patients with, you know, less intense morning sleep inertia? Just any color there on that education you called out for prescribers. Thank you. Kim? Sure. You know, I think if there are physicians out there that are hesitant to use a sleep-promoting agent, that just highlights the education that we need to do in this marketplace. You know, we're, as I mentioned earlier, working to educate prescribers that IH is actually a 24-hour condition and that we can address the multiple, both daytime and nighttime symptoms of IH. Once they understand that the daytime symptoms, including sleep inertia that you mentioned, are the result of poor sleep quality at night or what we call, you know, non-restorative sleep, they understand why treating with XYWAV, you know, at, at nighttime makes sense. It's, you know, we're making progress there, and, you know, education is key to, you know, changing their understanding and their beliefs. Your next question comes from the line of Ami Fadia with Needham & Company. Your line is now open. Great. Thanks for taking my question. I have one question and one follow-up. Just on suvecaltamide. Looks like the endpoint that you're studying is basically the same as what Praxis studied, for the study that they reported earlier this year, where some of the performance, the PS scores were, you know, Rob, let's come to you first on suvecaltamide. Yeah. Thanks, thanks for the question. We feel as though we learned a lot from the TCOM study, that was the phase II-A study, in a number of respects, including not only the endpoints, but how to measure the endpoints. We certainly, you know, noticed that it can be challenging to assess performance aspects of the TETRAS through a remote observer. In our trial, we're not doing that. Overall, the combined TETRAS endpoint having to do with activities of daily living and performance scale is agreed upon with the FDA, and is certainly something we were able to evaluate in our TCOM study, and we have confidence around, you know, our drug. I think you're highlighting differences in trial designs potentially, but I would also highlight differences in drugs. Our agent is a state dependent CaV3, that's critical because it allows you potentially to push the dose into higher efficacious ranges, given the differential activity on pathologic calcium ion channels versus normal resting state channels. We think we have a differentiated asset. We think we're able to push the dose and evaluate those three doses in a phase II design that's supported by our prior data. Kim, on the AG uptake, you wanna make a comment on that? Yeah, sure. I mean, we don't have exact data on that. You know, what I'll say is that, you know, we continuing to see nice uptake, as Bruce said, of Xywav, in the face of the AG. You know, switching dynamics can happen in a number of places. They can happen with the payer, which I don't think, you know, we're really seeing is the case right now. They can happen, you know, in the HCP offer, they can even actually happen at the pharmacy. We have talked about that, you know, Xywav in particular is not therapeutically equivalent or AB-rated, so we don't anticipate for switching at the pharmacy, with Xywav. That is certainly, a place where switching can happen from Xyrem to the AG. Your next question comes from the line of Balaji Prasad with Barclays. Your line is now open. Hi, good evening. Just two quick ones from me. Firstly, could you comment on the access that you have to the neurologists and physicians with regard to Epidiolex? Your thoughts around upside or commercial scope for the rest of the year, from an access perspective? Thanks. Secondly, minor question, should we anticipate any further updates on your litigation with Avadel, post the delisting direction that you received from the court? Thank you. Yeah, I'll take the second part of the question first. Okay. I'll take the second part of the question first, Dan, and just say that we're not gonna comment on ongoing litigation. Dan, why don't you talk about Epidiolex access sort of worldwide? Yeah, just sort of thinking a little more broadly about Epidiolex. The 20% year-over-year growth is great, and we remain confident that we're near blockbuster status on that brand. You know, in both markets, we've got strong HCP engagement and face-to-face engagement. We've got great access as we had some wins coming in to the U.S. market. And so it's we've always had the quantity of access, but now we've got the quality of access. In Europe, France was the last of the 5 major countries to get access to, and we're continuing to drive in the smaller markets both reimbursement as well as TSC reimbursement for that indication. I think this stage is well set, with the face-to-face interactions, you know, the ability to talk to the HCPs, not only about the clinical rationale, thanks to the seizure benefit, and the combination with clobazam. Also, some of the BECOME data from caregivers that was shared, which also had behavioral and cognition outcome. Then there's the areas that I mentioned in the presentation, or the prepared remarks about, you know, additional areas of growth with enhanced focus with adults. You know, adults were also getting to those physicians who had been impacted by COVID, and we see that plus long-term care, you know, as an area to, you know, further double down on, as well as optimal dosing, et cetera. I think the stage is well set, and, you know, we're pleased with the year-over-year growth and where the brand's going for, 2023. The next question comes from Madhu Kumar with Goldman Sachs. Your line is now open. Hey, thanks for taking our questions. Maybe on the corporate and business development front, how do you think about kind of the boundary between commercial versus near commercial assets as each quarter moves forward towards 2025? Is there a sense that, like, if you get to a certain point, it really shifts from commercial or near commercial to really wanting to be commercial assets to kind of contribute meaningfully to Vision 2025? Yeah. Thanks for the question. I would say, you know, our primary focus is ensuring that we're targeting assets that we think can have a really meaningful benefit for patients and meaningful impact and therefore benefit our business and our shareholders. With respect to that on commercial or, you know, near commercial, it really depends on the asset. It depends on the nature of the underlying business that it's, you know, an M&A type of opportunity where you're gaining access to a significant amount of expertise that you're going to continue, or whether we're looking at something that we can essentially lift and drop right into our footprint. You know, our focus is essentially the long-term value generation durability of the asset, how it fits into our overall portfolio. We do think there are opportunities to ensure that we're hitting our Vision 2025 goal. We're not focused myopically just on that goal. We're focused on broader growth and the, and the longer-term sustainability and enhanced value. Your next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is now open. Great. Good afternoon, Bruce and team. Congrats on the progress and thanks for taking my question. Bruce, maybe just spinning back to Xywav and as you go to market with the low sodium messaging, which we acknowledge is rather intuitive. With respect to just the simplicity of that messaging, I'm just curious, what barriers would you point to that you think are perhaps underappreciated by investors and others as that messaging gains traction and pull through with Xywav? Thanks so much. Kim, why don't I let you take this one? Sure. At this point, we do feel that our low sodium messaging is resonating with healthcare providers and with many patients as well, I think is evidenced by the amount of patients that have been transitioned to or started on Xywav. That being said, as we've, you know, brought most prescribers on board and many of them have, you know, switched a good portion of their patients. The most common barrier that we really hear two barriers that we hear from a prescriber is either, one, I've offered it to my patient, and they don't wanna switch because Xyrem has changed their lives. You know, we should never underestimate how much patients love their Xyrem and just don't wanna take any chance, no matter what you tell them about the product being the same active moiety in terms of switching products. You know, we're continuing to work on that patient side of things and educating patients about XYWAV and, you know, making nice progress over time. You know, the other reason that we hear most is that in the smaller healthcare practices, you know, they feel they just don't have the, you know, means to do the transitioning of the patient. We do see these offices starting, you know, patients on XYWAV, and they believe in sodium reduction, but it, you know, it does take some work to transition patients over. No problem for the larger offices with, you know, plenty of staff, but in some of these smaller offices, they just feel that they don't have the manpower to do that. Your next question comes from the line of Akash Tewari with Jefferies. Your line is now open. Hi, this is Arielle for Akash. Thanks for taking our question. I guess for the guidance, if the current trend in Q1 continues for the rest of this year, I guess with 250 IH patients add, 500 Xywav narcolepsy patients add and over 1,000 Xyrem patients lost, and assume the same year-over-year Epidiolex growth rate as what you had for, like, last year, neurofranchise seems to trend to the lower end of the full year guidance. What do you think we are missing here? Just a quick one on orexin. Alkermes said they will use different doses for narcolepsy type 1 and 2 patients for their orexin drug, and doses for type 2 patients will be several folds higher. Also they aim to dose below 10 mg. I guess, what's your view on this comment, and what dosage range are you targeting at right now for JZP441? Thank you. Yeah. I'll take the first part and then, come to Rob and just say, you know, our guidance coming into the year was a couple months ago and, was at the franchise level, neuroscience and oncology. We didn't, get into product level. As we're saying today, we're very pleased, with the way the first quarter, progressed. We think we're right in line with all our expectations to achieve That overall guidance. We're not gonna get more specific on that. Rob, maybe you could take the orexin part of the question. Yeah. The question I heard was, do we expect the dose to be different across patient populations? So, correct me if I didn't hear that. I would say the dose, of course, depends on the drug itself and factors such as bioavailability and potency, et cetera, et cetera. Within any given drug, there certainly is the possibility that different doses might be needed across different populations. We know that the relative level of orexin in the brain may differ between NT1 and NT2 or other sleepy populations because we're certainly interested in other populations as well. As you know, we have an ongoing program where we're evaluating and learning effects in healthy volunteers and ultimately use those data to transition to patients to understand best, you know, for 441, what the most appropriate dosing would be in different patient populations. Your next question comes from the line of Greg Fraser with Truist Securities. Your line is now open. Thank you. Good afternoon, folks. Just following up on the Xywav survey, did the survey include physicians that haven't yet prescribed Xywav as well as current Xywav prescribers? For those that plan to increase their prescribing of Xywav for IH, what were the some of the key reasons behind the predictions? I'm curious to hear your thoughts about diagnosis rates growing, patient awareness, growing. Any additional color on the survey learnings would be helpful. Thank you. Sure. Happy to do that. Yeah, I do believe the survey was of specialists in general. That increase would mean both those who've tried it and those who've yet to try it. In terms of, I don't have my fingertips whether in the survey we asked the reasons why, but I can tell you based on more qualitative feedback that we've had from physicians that the main reason that they are gonna continue to use more of it is that it's actually performing in line with what they expected from the phase three clinical trial results, which were better than healthcare provider community anticipated. They were very excited about those results, and they're very happy to see that it's performing in line with those results, and they're getting positive feedback from their patients. You know, along with that, the coverage from the payers has been there and, you know, the, you know, the patient experience in getting on the product, you know, all of that has been very positive. In, in line with, they have lots of these patients, and they've had, you know, really very little to be able to treat them with other than off-label, wake-promoting agents and stimulants over the years. Many of those patients taking those, you know, still, are not where they want them to be, you know, clinically. That's the simple story there, that we're hearing out in the marketplace. Your next question comes from the line of Jeff Hung with Morgan Stanley. Your line is now open. Thanks for taking my question. You mentioned that 60% of U.S. providers are using Epidiolex earlier in the treatment algorithm. What do you think it will take to further drive this in a greater proportion of providers, and what kinds of initiatives do you have to help accomplish this? Thanks. Kim, do you wanna start on that one? Yeah. I can speak from the U.S., again, we are, you know, quite pleased with how Epidiolex has been coming along, not just this quarter, but the past year. 20% growth year-over-year is very rewarding after, you know, years of being in under COVID and not being able to interact with this community that's still quite new to Jazz. Key to that really is continuing to have a very high level engagement with our customers that was absent there for a number of years in terms of access to treatment centers and physicians' offices. We're having some really great discussions and seeing the light bulb go off with quite a few of them and more, you know, prescribers coming on board. In terms of, you know, driving growth, you know, moving forward, that's very encouraging is that, you know, we've got some really great clinical data, the data we've been out there with for about a year now in terms of showing the, you know, the great impact that you can have in combining clobazam with Epidiolex. We're really getting a lot of traction with that in the marketplace. It's getting HCPs really to reconsider why they're not using more of it or using it earlier in the treatment algorithm, as that 60% shows. Then later on top of that, earlier this year, we started to go out there and talk about more than just seizure control through this caregiver survey called BECOME and showing HCPs quantitatively what they'd actually been hearing from caregivers since the launch of Epidiolex, and that is that the caregiver sees improvements in behavior and cognition, in the, you know, the patients that they're caring for. That combined with, you know, I'd say the adult setting, particularly the long-term care setting in the U.S., was slower to open up as many, you know, institutions were post-COVID. We've been able more recently to get in there, and we're excited about more fully penetrating the adult market, particularly in the long-term care setting. Last thing in the U.S., I'll say is that, you know, HCPs are still underdosing this product. They're not achieving optimal dosing, which is not achieving the optimal outcome for the patient. We're continuing and to deliver it and putting out there some new programs to really educate them on what optimally dosing Epidiolex looks like so they can have an even more positive experience with it, moving forward. That's within the U.S. Obviously we've got a number of ex-U.S. launches expected this year. Yeah. Kim, this is Dan. Just to add into it, as we see Epidiolex as one of our core growth drivers going into Vision 2025 and beyond, you know, we're really pleased with the real-world performance and, you know, assisting physicians that are in a multi pharmacy setting to change their habits and appreciate the unique profile of Epidiolex. In addition to all the great work that Kim and her team are doing in the U.S. and Sam Pearce are doing in Europe, we're also trying to leverage our full ability from an evidence generation. Some of that's gonna be with new indications, as we have with the EMAS in terms of exploring additional seizure types. some of it's gonna be observational studies, and some of it's gonna be, leveraging now an increasing number of medical records to show, you know, some of those trends that with higher and more optimal dosing, you can get to better, efficacy sooner. Exploring what we saw in the caregiver survey, for example, of, the beyond seizure benefit and seeing that in additional clinical data. You know, super excited for this, evidence generation that we've got, which should support, all regions, in the long-term growth of the product. Your next question comes from the line of Annabel Samimy with Stifel. Your line is now open. Annabel, we're not hearing you. Your line is open, Annabel. All right, operator, maybe we'll move on to the next one. All right. Your next question comes from the line of Ashwani Verma with UBS. Your line is now open. Hi, thanks for taking my questions. I had two. With respect to Avadel's Lumryz, in your view, could payers push narcolepsy patients towards using a once nightly product if Avadel comes in with a significant price discount? Second, do you think Lumryz can also be used off-label for IH? As we understand, IH patients can particularly struggle with taking a second dose. At least based on our care level feedback, we're getting to hear that up to 1/3 of IH patients can skip their second XYWAV dose. I don't know if you have any data that can elaborate on that point. Yeah. Kim, do you wanna jump in on this? Sure. I'd be happy to. You know, we talked a little while ago about payers in general. Really our strategy there is not changing. Again, we've been talking to payers for some time about, you know, the benefits of low sodium Xywav. We do believe that payers are understanding the importance of that, and they understand that HCPs are increasingly, you know, choosing Xywav, and that greater than 50% of patients are on Xywav today, and they're enjoying nice rebates on Xywav today. I really do believe that as other high sodium oxybates, you know, come onto the market and are ultimately added to formularies that Xywav is gonna continue to maintain a broad commercial coverage. You asked about idiopathic hypersomnia, and, you know, we don't expect the approval of FT218 will affect the IH market as it's not approved for idiopathic hypersomnia. You know, Xywav is still the only FDA-approved therapy, you know, for this condition. I think it's good to remind you that, you know, the Xywav can be administered as either a twice nightly or once nightly regimen, for IH in adult patients. That's what the label allows. All right. Operator, I think we've got time for one more question. Your last question comes from the line of David Amsellem with Piper Sandler. Your line is now open. Hey, thanks. Wanted to get your thoughts on the potential impact of pitolisant or Wakix, on Xywav to the extent that that product, eventually gets approved. Secondly, on the orexin, I think I've asked this before, but wanted to pick your brain on it. Any thoughts on, you know, why you're dosing it, at night, here? It seems a little counterintuitive. I was wondering if there's, if there's any, reason mechanistically or from a PK perspective, that you're doing so. Thank you. If I understood that question, that was about orexin. Rob, do you wanna take that one first? Yeah. I didn't fully understand it either, Bruce. The question is why would you be dosing orexin at night? I'm sorry. I didn't follow it. That's all right. I mean, it's a wakefulness drug, why are you dosing it at night? Oh, in our phase I? Correct. Yeah. We're leveraging a model in healthy volunteers where you sleep deprive healthies. Then measure the wakefulness of the intervention, when people have a high propensity for sleep. That turns out to be a pretty good model for disorders of daytime sleepiness like narcolepsy. It just gives us an opportunity to learn more about the drug and ultimately select doses when we get into patients who will then receive the drug during the day. Yeah. Maybe I'll start. Yeah, go ahead, Dan. Go ahead, Bruce. I was just gonna say on pitolisant, I mean, we, yeah, it's all gonna depend on the data, of course. You know, the Xywav has got some very powerful efficacy across multiple endpoints to treat the full condition and having a nighttime therapy is resulting in significant benefit through the day, whereas pitolisant, you know, similar to the wake-promoting agents will be used during the day. It's always gonna be a bit of a challenge for the long sleepers 'cause you have to be awake to take the oral dose. We don't see it as a significant threat or a displacement, but again, more treatment options for these patients, more commercial noise and education around IH would be a benefit for us. We have no further questions at this time. I will now turn the call back over to Bruce Cozadd. All right. Thanks, operator. Just to wrap up, thanks for the wide-ranging questions. I think we hit pretty much all the key topics that we covered in our news release on our script. I don't think we got many questions on oncology. I'll just reiterate, we're really excited for the growth of our oncology franchise led by Rylaze and Zepzelca. Didn't get many questions on zanidatamab. Lots of news upcoming there with, you know, additional clinical data presentations. We're looking forward to progress that program rapidly. You know, most important, we're continuing to be focused on Vision 2025. Remember that we've got upcoming phase II-B zanidatamab, BTC data at ASCO in June. That's the first time zani findings are gonna be featured during an oral session at a major oncology conference. Immediately after that presentation, we're hosting a webcast where Dr. Shubham Pant, who's presenting the data at ASCO, will review findings. We're also presenting multiple datasets at this year's American Academy of Sleep Medicine annual meeting. If any of you are at ASCO or Sleep, we may see you there. I'll also note we're participating in the upcoming RBC Investor Conference on May 16th. Let me close today's call by recognizing our Jazz colleagues for their work to deliver new therapeutic options to patients. I wanna thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today. This concludes today's conference call. Thank you for your participation. You may now disconnect.