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Bruce Cozadd: Thank you, Andrea. Good afternoon, everyone, and thanks for joining us today. I'll start on slide five. In the third quarter, strong operational performance across all areas of our business enables us to deliver significant year-over-year top and bottom-line growth for the quarter, building on a productive first half of the year. I'm pleased to report that based on our performance through the first three quarters of 2022, we are raising the midpoint of our full year revenue guidance, reflecting increases in the guidance midpoints of both our neurology and oncology net sales projections. Renée will discuss these and other updates to our guidance later in the call. Our commercial business continues to execute well.

In our neuroscience franchise, we are seeing compelling adoption of Xywav in both narcolepsy and idiopathic hypersomnia, or IH, and we're pleased to have achieved another important milestone. Exiting October 2022, there are now more narcolepsy patients taking Xywav than Xyrem. Looking ahead, we remain confident in the durability of Xywav as a core component of our commercial portfolio. For Epidiolex, we are seeing growth driven by underlying demand. And recently, we completed the pricing and reimbursement process in France, paving the way for commercial launch in this key European market. We believe Epidiolex can become a cornerstone of treatment for refractory seizures and remain confident in Epidiolex's potential to achieve blockbuster status.

Moving to oncology. Zepzelca is established as the treatment of choice in second-line small cell lung cancer. Our ongoing clinical development efforts are focused on expanding within that indication as well as looking to address additional patient populations who may benefit from therapy. Rylaze had another strong quarter, as momentum with prescribers has continued. Rylaze remains the only therapy available to patients in the US who experience a hypersensitivity reaction to E. coli-derived asparaginase. Dan will provide a detailed overview of our performance across the commercial portfolio later in the call. Our pipeline efforts were productive again this quarter, with multiple clinical trial starts. We enrolled the first patient in our Phase 1 trial evaluating JZP815, our pan-RAF inhibitor for the treatment of solid tumors that contain mutations in the MAPK pathway.

We initiated a Phase 2 trial for suvecaltamide in Parkinson's disease tremor, which complements our ongoing Phase 2b trial in essential tremor. And for Epidiolex, we initiated our Phase 3 trial evaluating Epidiolex in patients with epilepsy with myoclonic atonic seizures, or EMAS, as well as enrolled the first patient in our pivotal trial in Japan. And just last month, we announced a licensing agreement to further expand our late-stage pipeline as part of our agreement with Zymeworks to acquire development and commercialization rights to zanidatamab, a novel HER2-targeted bispecific antibody in the US, Europe, Japan and other markets. Rob will provide additional comments on our pipeline programs in progress, including zanidatamab later in the call.

Turning to slide six. Vision 2025 includes three components central to driving sustainable growth and enhanced value as we transform our company; commercial, pipeline and operational excellence. Starting with commercial, we're positioned to grow revenue to $5 billion in 2025 through a combination of existing products, potential new therapies emerging from our pipeline and corporate development. Our R&D organization is advancing key programs, addressing significant patient needs in neuroscience and oncology and we anticipate delivering at least five novel product approvals by the end of the decade through a combination of existing pipeline programs and corporate development. The zanidatamab transaction is an example of a corporate development initiative that could contribute to both our commercial and pipeline objectives.

And on operational excellence, our 2021 adjusted operating margin was 43% and we plan to improve that by 5 percentage points from 2021 to 2025, delivering more of our top line through to the bottom line. With Vision 2025 as our road map, we continue to transform our business and operating model to ensure we have the appropriate structure in place to scale, while continuing to invest in our business in order to meet our goals. We believe our accomplishments in the third quarter position us for a strong ending to the year, entering 2023 with considerable momentum across the business and well positioned to achieve Vision 2025. I'll now turn the call over to Dan to review our third quarter commercial performance, after which Rob will share an update on the progress of our R&D programs.

Renée will provide a financial overview, including corporate development update, and then we'll open the call up for Q&A. Dan?

Dan Swisher: Thanks, Bruce. I'm excited about the progress we've made on the commercial portfolio and pleased to report on our strong third quarter performance. Starting with neuroscience on slide eight. We are maintaining positive momentum for our oxybate franchise. With Xywav, we have meaningfully advanced patient care with a lower sodium oxybate product. In the third quarter, average active oxybate patients increased to approximately 17,600 and representing growth of approximately 10% compared to the same period last year. There were approximately 9,500 active Xywav patients exiting the quarter resulting from strong adoption in both narcolepsy and IH. We continue to see strong uptake of Xywav for narcolepsy in the third quarter and we exited the quarter with approximately 8,050 narcolepsy patients taking Xywav.

As Bruce mentioned, we've reached an important milestone with more narcolepsy patients taking Xywav and Xyrem. In addition to continued adoption of Xywav among current Xyrem patients, the large majority of new to oxybate narcolepsy patients are being prescribed Xywav. We expect that trend to continue as our educational efforts around the benefits of lower sodium oxybate are resonating with prescribers and patients. With continued strong adoption in IH, we have a substantial growth opportunity. There is a high level of engagement and receptivity in the market for a new IH therapy. We have secured reimbursement on par with narcolepsy €“ and importantly, we continue to grow the IH prescriber base. As physicians gain experience prescribing Xywav for IH and they have the opportunity to observe its clinical benefits within their own practices, we are seeing increased enthusiasm for identifying appropriate patients and initiating therapy.

Exiting in the third quarter, there were approximately 1,450 IH patients taking Xywav, and we're focused on educating prescribers about IH diagnosis and patient identification. Xywav is the first and only FDA-approved therapy for IH and we are confident in our ability to maximize its potential in this underserved market. We expect that Xywav will be the oxybate of choice in 2023, even as authorized generics enter the market and as branded competition potentially becomes available. Xywav is the only lower sodium oxybate and is the only oxybate approved for both narcolepsy and IH. We have confidence that Xywav is a durable product that will continue to contribute meaningfully to Jazz's commercial portfolio. Turning to slide nine. In Epidiolex, net product sales increased by 22% in the third quarter of 2022, compared to the same period last year, driven primarily by demand.

Our overall volume of engagement with health care providers continues to grow, which is a positive development for the brand given the promotionally sensitive nature of Epidiolex, and the anti-epilepsy market as a whole. We're also pleased that our market research indicates nearly 60% of prescribers are moving Epidiolex up in the treatment algorithm. Polypharmacy is the dominant treatment strategy in treatment refractory epilepsy and one approach we have taken that is resonating with US healthcare professionals is to highlight data on the synergistic effects of using Epidiolex in combination with Clobazam. Clobazam is one of the most widely used anti-seizure therapies, and healthcare providers have been very impressed with the combination data.

Both Epidiolex and Clobazam have demonstrated effectiveness in reducing seizure frequency in LGS, Dravet and TSC., In combination, Epidiolex plus Clobazam have been shown to reduce seizure frequency by around 60% in LGS and Dravet and nearly 50% in TSC compared to an approximately 30% reduction in seizures for patients giving Clobazam plus placebo. These data are particularly relevant for healthcare professionals who have limited experience with Epidiolex, offering a strong rationale to begin incorporating Epidiolex into their patient's treatment regimens. There has also been continued adoption and growth of Epidiolex in markets outside the US and we recently completed the pricing and reimbursement process in France. We expect to launch later this year, at which point Epidiolex will be reimbursed and commercially available in all five major European markets, including France, Germany, the United Kingdom, Spain and Italy.

We also have opportunity for additional growth coming from multiple new markets and indication launches throughout this year and next. Given Epidiolex' differentiation in the anti-epilepsy drug market and its ability to be combined with a wide range of other therapies, we remain confident it will emerge as a global standard of care and treatment-resistant epilepsies. Now moving to oncology. I'll begin with Zepzelca on Slide 10. We have established Zepzelca as the treatment of choice in second-line small cell lung cancer. In third quarter, net product sales were in line with our expectations. As we noted in our third quarter 2021 earnings announcement, Zepzelca's 3Q 2021 net product sales were favorably impacted by approximately $10 million, relating to a reduction in the returns accrual rate, which was due to lower-than-estimated actual returns.

Excluding that impact, net product sales increased by approximately 14% in 3Q 2022 compared to the same period in 2021. We're also exploring ways to further expand market share in our current indication by investing in real-world evidence and observational studies that we believe will generate additional data around Zepzelca's utility in a broad range of second-line small cell lung cancer patients. Rob will cover our development plans for Zepzelca in more depth, 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. Turning to Slide 11. We have continued to see strong demand for Rylaze since our US launch in the third quarter of 2021.

This reflects robust brand awareness among customers and prescribers, confidence in a high-quality reliable supply of product and Rylaze's position as the only therapy available to patients in the US, who have a hypersensitivity reaction to E. coli-derived asparaginase. We continue to hear from healthcare professionals that based on the availability of Rylaze, they are returning to best clinical practice and switching to non-E. coli-derived asparaginase earlier when there has been an initial hypersensitivity reaction observed. Rylaze has been adopted almost universally in US pediatric oncology protocols and we are encouraged to see that there is increasing use of Rylaze in the treatment of adolescents and young adults. Now I will turn the call over to Rob to provide an R&D update.

Rob?

Rob Iannone: Thanks Dan. I'll kick things off on slide 13. In mid-October, we announced our agreement to license development and commercialization rights to Zanidatamab. This is an extremely promising program. Zanidatamab is a novel HER2-targeted bispecific antibody with biparatopic binding that has the potential to transform the current standard-of-care in multiple HER2-expressing cancers. The ongoing clinical program for Zanidatamab is well designed and includes anticipated near-term data readouts that could support registration. Topline data from a pivotal trial in biliary tract cancer performance BTC, are expected by year-end, and topline data from the ongoing pivotal Phase 3 trial in gastroesophageal adenocarcinoma, or GEA are expected in 2024.

Potential approval in BTC would enable us to deliver this therapy to patients as quickly as possible. that allow health care professionals to gain real-world experience with this drug in BTC prior to potential approval in other larger cancer populations such as GEA. As an oncologist, I'm impressed to see monotherapy activity with Zanidatamab across multiple HER2-expressing tumor types, including cases resistant to prior HER2 therapies. And the ongoing trials are expected to provide data that will inform development beyond BTC, GEA. We're looking forward to working with the experienced team at Xymarks , to achieve our shared objective of realizing the full potential of Zanidatamab patients. Slide 14 provides an overview of our near-term R&D opportunities.

We are advancing a number of programs across the pipeline. Within neuroscience, I'm pleased to report that we have initiated our pivotal Phase 3 trial for Epidiolex in Japan that includes Dravet, LGS and TSC with the first patient enrolled in October. We have also initiated our Phase 3 trial for Epidiolex in epilepsy with myoclonic atonic seizures, or EMAS. This would add a potential fourth indication to our label and provide the first clinical data on a floor seizure type. Our Phase 2 trial for JZP150 in post-traumatic stress disorder is progressing, as is our Phase 2b trial for Suvecaltamide, or JZP385, for the treatment of essential tremor. And based on preclinical evidence and significant patient need, we have initiated a separate Phase 2 trial for Suvecaltamide in Parkinson's disease, too, and expect to enroll the first patient by the end of the year.

We've completed our analysis of the nabiximols MSS1 trial. We have assessed the nabiximols program's potential to support regulatory approval for multiple sclerosis related to spasticity in the US as well as in the context of our broader pipeline opportunities. We have made the decision to discontinue the program. There is no impact to patients currently enrolled in the trial, and they will complete the study per the clinical trial profile. On behalf of my colleagues at Jazz, I want to extend our gratitude to the investigators, clinical sites, patients, and their families who participated in the recent nabiximols trials. Sativex, the brand name for nabiximols, was approved outside the US for the treatment of MS-related spasticity based on a comprehensive clinical trial program, including three positive Phase 3 randomized controlled clinical trials completed in Europe.

We continue to believe that Sativex confers benefit to patients with MS-related specificity and are continuing to support the availability of Sativex in the 29 markets outside of the US where it is approved, so that it remains available to patients who benefit from therapy. We also remain excited about the GW cannabinoid platform and are committed to advancing cannabinoid programs, including those beyond Epidiolex, with the potential to address critical unmet patient needs. Moving to oncology. We continue to execute our robust development effort for Zepzelca. This includes an ongoing Phase 3 trial supported by Jazz and Roche to evaluate Zepzelca in combination with Tecentriq in first-line extensive-stage small cell lung cancer. A confirmatory Phase 3 trial in second-line small cell lung cancer being run by our partner, PharmaMar, and our own post-marketing observational trial in second-line small cell lung cancer.

We are also exploring Zepzelca in other solid tumors in a Phase 2 basket trial. Turning to Rylaze, FDA is continuing to review our sBLA for Rylaze to update our label to a Monday, Wednesday, Friday intramuscular dosing special, with patients receiving 25 milligrams per meter squared on Monday and Wednesday and 50 milligrams per meter squared on Friday. This schedule, which is more in line with current clinical practice to avoid weekend dosing, would allow patients to maintain a clinically meaningful level of serum asparaginase activity through the entire duration of treatment. Currently, the labeled dosing schedule is every 48 hours at 25 milligrams per meter squared. We also completed a separate sBLA to support intravenous administration. Similar to the review of our original BLA, both the Monday, Wednesday, Friday, dosing schedule and the IV formulation supplemental BLAs are being reviewed under the real-time oncology review program.

While we do not believe these label updates would have a significant impact on usage, they do have the potential to improve the Rylaze experience for clinicians and patients. We have also completed an MAA submission to the European Medicines Agency for Rylaze, which included Monday, Wednesday, Friday, and every 48-hour dosing schedules, as well as IV and IM administration with potential approval in 2023. Looking at our earlier stage programs, we recently reached the milestone for JZP815, our pan-RAF inhibitor for the treatment of solid tumors that contain mutations in the MAP kinase pathway, enrolling the first patient in our Phase 1 clinical trial in October. We are also advancing a number of programs towards IND submission. In summary, our R&D portfolio has evolved dramatically over the last 24 months.

We have a robust pipeline of mid and late-stage programs, with data readouts expected through 2024, further complemented by promising early-stage programs. I've never been more excited about the compounds in our pipeline. With our R&D organization integrated following the GW transaction, we have an exceptionally talented, experienced and diverse team, with the expertise and capabilities to rapidly drive development, with the goal of delivering additional innovative therapies to patients.. Now, I will pass the call off to Renée for a financial update. Renée?

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Renée Galá: Thanks, Rob. I'll begin on slide 16. Our third quarter financial results reflect strong execution across the business. We achieved impressive top and bottom line growth with third quarter total revenues of $941 million, representing growth of 12% compared to the same quarter in 2021. Our continued focus on both the top and bottom line drove third quarter adjusted net income of $370 million, a 42% increase compared to the same period in 2021. Adjusted EPS was $5.17 in the third quarter, a 23% increase compared to the same period last year. Adjusting our 3Q 2021 results for the accounting change for convertible debt, our adjusted EPS growth for 3Q 2022 would have been 38% compared to the same period in 2021. Our updated guidance is outlined on slide 17.

Based on results from the third quarter, we are raising the midpoint for all of our revenue and net sales guidance metrics and updating the ranges for full year total revenue guidance to $3.6 billion to $3.7 billion, neuroscience net product sales to $2.7 billion to $2.8 billion, and oncology net product sales to $860 million to $920 million. In all three instances, we have cut the upper end of our guidance the same, while increasing the lower end. With regard to OpEx, we continue to focus on strategic, disciplined use of capital. We noted last quarter that we expected to come in towards the lower end of our guidance range, and we are now narrowing our SG&A expense guidance to $1.09 billion to $1.12 billion, and reducing R&D expense guidance to $490 million to $520 million.

We are excited about our pipeline and investing in multiple ongoing clinical and preclinical programs and the reduction in R&D guidance was driven primarily by the discontinuation of the nabiximols program and continued focus on financial discipline. We are raising our 2022 non-GAAP ANI guidance range to $1.225 billion to $1.275 billion. This is a $35 million improvement at the midpoint despite the inclusion of a $50 million upfront payment related to the Zanidatamab transaction that we expect to pay by year-end upon expiration of the HSR waiting period. Should we decide to continue with the transaction following review of data from Zymeworks, we anticipate the second upfront payment of $325 million would be recognized in the fourth quarter, with both payments included in our IP R&D line.

Turning to slide 18. Our non-GAAP net leverage ratio was approximately 2.9 times at the end of the third quarter. We have now delevered two full turns since the close of the GW transaction in May 2021, which we've accomplished through both paying down debt and increasing adjusted EBITDA. Our focus remains on managing the balance sheet through disciplined capital allocation to ensure we are investing at our highest priority initiatives across the business and leveraging our strong cash flow all of which provides us with meaningful flexibility for further corporate development initiatives. Corporate development is a foundational pillar of our strategy to deliver long-term growth and value for both patients and shareholders and is important to our efforts to achieve Vision 2025.

We believe our recent transaction with Zymeworks is an ideal strategic fit for Jazz and exemplifies our approach to corporate development. This transaction has the potential to further diversify our commercial portfolio in the near term with an innovative therapy that we can evaluate in multiple tumor types following potential initial approval in BTC. A few aspects of this transaction that I'll call particular attention to. First, it is aligned with our strategic focus on opportunities where we not only have unique insights and there is critical unmet patient need, but where we can also leverage Jazz's existing integrated capabilities and global infrastructure to commercialize efficiently. Notably, in the US, there's a significant overlap with our existing Zepzelca call universe where we have built strong relationships and quickly established Zepzelca as the standard of care in second-line small cell lung cancer.

Should we continue in the licensing agreement and secure approval for Zanidatamab in BTC and GEA, which are the first two potential indications, there is a concentrated physician audience for efficient commercialization. Second, this is a durable asset with the opportunity for significant regulatory exclusivity, following potential approval and a robust patent portfolio expiring several years later. And third, as Rob noted, Zanidatamab has potential in a broad range of cancers. As we look to continue to diversify our commercial portfolio, we believe this type of asset and transaction offers significant upside with a relatively modest upfront investment, including a deal structure that is weighted towards achievement of regulatory and commercial milestones rather than higher upfront payments.

I'll also point out that the scope and structure of the transaction, coupled with our strong cash flow, leaves us with plenty of bandwidth to continue to be active on the corporate development front. As I noted on the previous slide, with respect to the GW transaction, we've shown the ability to lever up and then quickly delever in order to opportunistically transact and we ended the quarter with nearly $900 million in cash, cash equivalents and investments. As in prior years, we plan to provide 2023 guidance in our full year earnings disclosure. However, I'd like to comment on two items that are shaping our perspective on 2023 and Vision 2025. First, upcoming oxybate competition. As we've previously noted, we expect that Xywav will remain the oxybate of choice in 2023 and even as the first Xyrem authorized generic enters the market, either late this year or early next year with others to follow and branded competition potentially becomes available.

We have orphan drug exclusivity that extends to 2027 for narcolepsy and 2028 for IH, as well as Orange Book listed patents that extend out to 2033. We also expect to receive meaningful royalties for all Xyrem authorized generics, and we expect the oxybate franchise, led by Xywav, will continue to be an important component of our revenue stream in the coming years. Second, operating margin improvement. Our updated 2022 guidance implies an operating margin of 49% at the midpoint, positioning us to both further invest in our business in 2023 and 2024 and achieve the operating margin target outlined in Vision 2025. 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 shareholders.

I'll now turn the call back to Bruce for some final remarks.

Bruce Cozadd: Thanks, Renée. I'll conclude our prepared remarks on slide 20. We finished the third quarter with strong momentum across our business and are in an excellent overall financial position despite a challenging period in the biotech sector, and global markets in general. Our commercial efforts have driven strong uptake for Xywav in both narcolepsy and IH, growth in Epidiolex resulted in an outstanding launch for Rylaze and established Zepzelca as the treatment of choice in second-line small cell lung cancer. Our R&D team continues to advance multiple mid and late-stage programs and we expect to submit several INDs through 2023. The pending addition of zanidatamab, strengthens our oncology pipeline to add to program with anticipated near-term clinical milestones and the potential to contribute to our Vision 2025 commercial and R&D objectives.

Operational excellence also remains a key area of focus, including our goal of improving our adjusted operating margin, while maintaining diligent and disciplined capital allocation to drive shareholder value. In summary, we remain on track to achieve Vision 2025, and our updated guidance reflects our team's execution across the business in the first three quarters of 2022. That concludes our prepared remarks. I'd now like to turn the call over to the operator to open the line for Q&A.

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