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spk17: Good day, and thank you for standing by. Welcome to the Q3 2022 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 11 on your telephone, and you will then hear an automated message advising your hand is raised. 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 of Investor Relations. Please go ahead.
spk12: Thank you, Operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its third quarter 2022 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 Kozad, Chairman and Chief Executive Officer, Renee Galah, Executive Vice President and Chief Financial Officer, Dan Swisher, President and Chief Operating Officer, and Rob Yannone, Executive Vice President, Global Head of R&D. Kim Sablich, Executive Vice President and General Manager, U.S., will join the team for Q&A. On slide 2, I'll remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, including expectations related to Vision 2025 and our guidance for 2022, growth potential and anticipated development programs and pipeline, regulatory activities and commercialization milestones, goals and expected timing, and statements with respect to our licensing agreement for Zana Data Map that is subject to closing conditions, 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 the forward-looking statements made on today's press release. 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. Reconciliations of GAAP to non-GAAP financial measures are included in today's press release and in the slide presentation available on the investor section of our website. I'll now turn the call over to Bruce.
spk10: 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 enabled 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. Renee 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 ZyWave 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 ZyWave than ZyREM. Looking ahead, we remain confident in the durability of ZyWave 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, Zepzelka 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. Rylase had another strong quarter as momentum with prescribers has continued. Rylase remains the only therapy available to patients in the U.S. 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 one trial, evaluating JCP815, our pan-RAF inhibitor, for the treatment of solid tumors that contain mutations in the MAPK pathway. We initiated a Phase II trial for subacaltimide in Parkinson's disease tremor, which complements our ongoing Phase IIb trial in essential tremor. And for Epidiolex, we initiated our Phase III trial evaluating Epidiolex in patients with epilepsy with myoclonic atonic seizures, or EMOS, 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 ZymWorks to acquire development and commercialization rights to ZanyDatamab, a novel HER2-targeted bispecific antibody in the U.S., Europe, Japan, and other markets. Rob will provide additional comments on our pipeline programs in progress, including ZanyDatamab, 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 Zany Data Map 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 five percentage points from 2021 to 2025, delivering more of our top line through to the bottom line. With Vision 2025 as our roadmap, 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, Renee will provide a financial overview, including a corporate development update, and then we'll open the call up for Q&A. Dan?
spk05: 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 Oxibate franchise. With ZyWave, we have meaningfully advanced patient care with a lower sodium oxibate product. In the third quarter, average active oxibate patients increased to approximately 17,600, representing growth of approximately 10% compared to the same period last year. There were approximately 9,500 active ZyWave patients exiting the quarter, resulting from strong adoption in both narcolepsy and IH. We continue to see strong uptake of ZyWave for narcolepsy in the third quarter, and we exited the quarter with approximately 8,050 narcolepsy patients taking ZyWave. As Bruce mentioned, we've reached an important milestone with more narcolepsy patients taking ZyWave than ZyREM. In addition to continued adoption of ZyWave among current ZyREM patients, the large majority of new to oxidate narcolepsy patients are being prescribed ZyWave. We expect that trend to continue as our educational efforts around the benefits of lower sodium oxidate 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 ZyWave 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 ZyWave. We're focused on educating prescribers about IH diagnosis and patient identification. ZyWave 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 ZyWave will be the oxybate of choice in 2023, even as authorized generics enter the market and as branded competition potentially becomes available. ZyWave is the only lower sodium oxibate and is the only oxibate approved for both narcolepsy and IH. We have confidence that ZyWave 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 healthcare 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 U.S. 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 patients' treatment regimens. There has also been continued adoption and growth of Epidiolex in markets outside the U.S., 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's 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 in treatment-resistant epilepsies. Now moving to oncology, I'll begin with ZebZelka on slide 10. We have established ZebZelka as the treatment of choice in second line small cell lung cancer, and third quarter net product sales were in line with our expectations. As we noted in our third quarter 21 earnings announcement, ZebZelka 3Q21 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 3Q22 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 ZebZelka's utility in a broad range of second-line small cell lung cancer patients. Rob will cover our development plans for ZebZelka 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 Riley since our U.S. 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 Rylase is positioned as the only therapy available to patients in the U.S. who have a hypersensitivity reaction to E. coli-derived asparaginase. We continue to hear from healthcare professionals that based on the availability of Rylase, 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. Rylase has been adopted almost universally in U.S. pediatric oncology protocols, and we are encouraged to see that there is increasing use of Rylase in the treatment of adolescents and young adults. Now I will turn the call over to Rob to provide an R&D update. Rob?
spk08: Thanks, Dan. I'll kick things off on slide 13. In mid-October, we announced our agreement to license development and commercialization rights to Xanadatamab. This is an extremely promising program. Xanadatamab is a novel HER2-targeted bispecific antibody with bi-paratopic binding that has the potential to transform the current standard of care in multiple HER2-expressing cancers. The ongoing clinical program presented data map is well designed and includes anticipated near-term data readouts that could support registration. Top line data from a pivotal trial in biliary tract cancer, or PTC, are expected by year end. And top line data from the ongoing pivotal phase three 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 and allow healthcare professionals to gain real-world experience with this drug in BTC prior to potential approval in other larger cancer populations, such as DEA. As an oncologist, I'm impressed to see monotherapy activity with Xanadatamab 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 and GEA. We're looking forward to working with the experienced team at Zymeworks to achieve our shared objectives of realizing the full potential of Xanadatamab for 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 three trial for Epidiolex in Japan that includes Dravet, LGS, and TSC, with the first patient enrolled in October. We have also initiated our phase three 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 fourth seizure type. Our Phase II trial for JZP150 and post-traumatic stress disorder is progressing, as is our Phase IIb trial for suvacaltamide, or JZP385, for the treatment of essential Trenner. And based on preclinical evidence and significant patient needs, We have initiated a separate phase two trial for suvacaltamide in Parkinson's disease tremor and expect to enroll the first patient by the end of the year. We have completed our analysis of the nabiximols MSS1 trial. We have assessed the nabiximols program's potential to support regulatory approval for multiple sclerosis-related spasticity in the U.S., 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 protocol. On behalf of my colleagues at JAS, I want to extend our gratitude to the investigators, clinical sites, patients, and their families who participated in the recent Dabixavals trials. Datavex, the brand name for Dabixavals, was approved outside the U.S. for the treatment of MS-related spasticity based on a comprehensive clinical trial program, including three positive phase three randomized controlled clinical trials completed in Europe. We continue to believe that Sativex confers benefit to patients with MS-related spasticity and are continuing to support the availability of Sativex in the 29 markets outside of the U.S. 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 a robust development effort for Zypselka. This includes an ongoing phase three trial supported by Jazz and Roche to evaluate Zypselka in combination with Dicentric, in first-line extensive-stage small-cell lung cancer. A confirmatory phase three trial in second-line small-cell lung cancer being run by our partner, PharmaMar, in our own post-marketing observational trial in second-line small-cell lung cancer. We are also exploring Zipzelka and other solid tumors in a phase two vascular trial. Turning to Rylase. FDA is continuing to review our SPLA for Rylase to update our label to a Monday, Wednesday, Friday intramuscular dosing schedule 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 of 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 Rylase experience for clinicians and patients. We have also completed an MAA submission to the European Medicines Agency for Rylase, 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 I clinical trial in October. We're also advancing a number of programs toward 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 Renee for a financial update. Renee?
spk16: 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 3Q21 results for the accounting change for convertible debt, our adjusted EPS growth for 3Q22 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 to $3.7 billion, neuroscience net product sales to $2.7 to $2.8 billion, and oncology net product sales to $860 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 toward the lower end of our guidance range, and we are now narrowing our SG&A expense guidance to $1.09 to $1.12 billion, and reducing R&D expense guidance to $490 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 Nabiximals program and continued focus on financial discipline. We are raising our 2022 non-GAAP ANI guidance range to $1.225 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 Zana DataMap 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 ZimeWorks, we anticipate the second upfront payment of $325 million would be recognized in the fourth quarter with both payments included in our IPR&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 delivered 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 Zyneworks 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 JAS's existing integrated capabilities and global infrastructure to commercialize efficiently. Notably, in the U.S., there's a significant overlap with our existing Cephselka call universe, where we have built strong relationships and quickly established Cephselka as the standard of care in second line small cell lung cancer. Should we continue in the licensing agreement and secure approval for Xanadatomab and 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, Xanadatamab 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 de-lever 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 Oxibate competition. As we've previously noted, we expect that ZyWave will remain the oxybate of choice in 2023, even as the first ZyRum 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 Oxibate franchise, led by XyWave, will continue to be an important component of our revenue stream in the coming years. Second, operating margin improvements. 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.
spk10: Thanks, Renee. 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 Zywave in both narcolepsy and IH. Growth in Epidiolex resulted in an outstanding launch for Rylase and established Zepsulca 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 ZanyDataMap strengthens our oncology pipeline and adds a 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.
spk17: As a reminder, to ask a question, please press star 1-1 on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from Ken Cacciatore with Cohen. Your line is now open.
spk07: Hi, everyone. Great progress, great performance. just going to focus on ZyWave. Bruce, can you talk about, or maybe Dan, talk about the retention you're seeing on the early patients? I know it's still just the initial patients using it, but any views on the retention rate? And I know you described that there's an increasing number of prescribers. Can you give a sense of where it's already seeing repeat prescribing by these clinicians? And then lastly... some folks are still worried that this is a bolus that we're seeing as you're adding these patients. Can you talk, as you've had more experience in the field, about your view on the patient size here? You described in the past as being similar to narcolepsy. Do you still think that this eventually could equate to where Zyrum was in narcolepsy, what ZyWave can achieve in IH? Thanks so much.
spk10: Yeah, Ken, I'll start with a comment on the overall market opportunity and then maybe let Kim take the questions on what we're seeing in initial patient experience with CyWave. On the overall market size, while we do believe that the market opportunity as we move forward in time is very large and may in fact be the size of the narcolepsy opportunity if you look at diagnosed and undiagnosed patients. Our initial focus, as we've talked about, is going after that segment of the market where we know patients already have a diagnosis of IH and are actively seeking medical care. So it's a subset of that, but yes, the opportunity long-term is larger. Kim?
spk20: Sure. Yes. What I'll emphasize is we're still seeing a really high level of engagement and receptivity in the market overall for this new IH therapy. And as you mentioned, Ken, we're continuing quarter over quarter to bring new prescribers on and grow that prescriber base. Among those prescribers who have utilized the product so far in their patients, we're hearing very positive experience and ultimately that they're seeing the product perform both efficacy and safety-wise in line with what we saw in the phase three clinical study. So very positive experiences as well as positive experience with the, you know, availability of the product on formularies. Again, you know that we've got 90% coverage for both narcolepsy and IH and the commercial patient population at this point in time. So overall, what we're seeing and hearing is that as, you know, as a healthcare provider gets their own firsthand clinical experience with prescribing ZyWave in this idiopathic hypersomnia population and have the ability to observe its clinical benefits within their own practices, we really see increased enthusiasm about it and an effort on their part to start to identify additional appropriate patients in which they can initiate therapy. So all of this positive signal from those that have utilized it, as well as those who have not, allows us to continue to be really confident in our ability to maximize the potential of ZyWave in this really underserved market. And it makes us very pleased that we're continuing to grow ZyWave across both narcolepsy and IH and putting us well on track to be the oxidative choice in 2023.
spk10: And Ken, maybe I'll just wrap by saying if you contrast what physicians are seeing with ZyWave and IH, with the options they had available to them before our launch. You know, they were using unapproved drugs off-label, primarily just to address EDS. And as a reminder, ZyWave is broadly indicated to treat the disease of the hepatic hypersomnia across a number of important symptoms. And so we're seeing that effectiveness come through to both patients and clinicians.
spk07: Thanks so much.
spk17: Please stand by for our next question. Our next question comes from Jessica Phi with JP Morgan. Your line is open.
spk15: Great. Good evening, guys. Thanks for taking my question. Does the IRA influence your business development priorities or how you evaluate potential targets? And what about within your own pipeline? Does it impact your thinking on which indications or efforts to prioritize?
spk10: So, Jess, I would say, like other companies in our industry, we're continuing to evaluate the impact of the IRA legislation, particularly as we learn more over time about how it's going to be implemented, to see how that will impact our investment decisions And it may impact our investment decisions across our R&D portfolio, but also, importantly, across corporate development opportunities. There are parts of IRA we liked, including really trying to address out-of-pocket costs for patients. That was a step in the right direction. There are other provisions that we think are actually challenging to innovators in terms of some of the probably unintended consequences or not fully recognized consequences in terms of providing a return on capital for those investments. So we, like everyone, will be looking at potential impacts. I don't think we believe for our existing commercial portfolio of products. We see much, certainly in any near-term period, that would concern us. But We will take it into account when we're making longer-term investment decisions.
spk18: Thank you.
spk17: Please stand by for our next question. Our next question comes from Jason Gerberby with Bank of America. Your line is now open.
spk09: Hey, guys. Thanks for taking my questions. First question, not asking for guidance, but just curious if directionally you see 2023 as a revenue growth year. And the reason I ask is because you have this 2025 target out there. And I think from an investor standpoint, it's easier to believe that if you think 2023 is a growth year. And given the generic competitor entry, I think it would just be something that would be helpful if you guys could address at some threshold. And then the Epidiolex quarter was impressive. I'm just curious to if you can speak a little bit to, like, the one or two biggest growth drivers on a year-over-year basis. You know, you guys were pushing into adults, into rural and suburban kind of areas. So just kind of curious if you can give us a little bit more color on what specifically were some of the bigger growth drivers for Epidiolex. Thanks.
spk10: Maybe I'll ask Rene to take the broader revenue perspective. trends question, and I hear that you're not asking for guidance, so thank you. And then maybe I can turn it over to Dan and Kim to talk a little bit about our Epidiolex growth.
spk16: Yeah, thanks, Bruce. And Jason, thanks for the question. So with respect to 23, as as you would expect, we typically provide that full year guidance for a new year alongside our full year results in the first quarter. So, you can expect that from us in early 2023. However, with respect to how we're thinking about 2023 relative to AGs or potential competition, I would say, you know, we continue to expect Zywave to be the Oxibate therapy of choice. We're confident in the path that we have ahead of us for 2025 and the ability of the Oxibate franchise more broadly to deliver $2 billion of revenue across Zywave, branded Zyrem, and then the royalties of AGs, which of course carry meaningful economics to us. But going back to 2023 and Zywave, You know, as you would have listened to our comments and looked at our third quarter results, you know, we believe we are very well positioned for ZyWave to be the therapy of choice within the OxyBates for the year. We've established excellent payer coverage for both narcolepsy and IH. You've heard today we now have more narcolepsy patients on ZyWave than ZyREM. another important milestone for the brand. And we've also in the third quarter now generated over $250 million of net sales in a single quarter with CyWave. So all of this points to meaningful progress and success for the brand and positions us really well as we prepare to enter 2023. Kim?
spk20: Yep. So I'll start off by talking about the U.S. and, you know, we have really seen a number of things, you know, giving us momentum here in the U.S. and leading us to be optimistic about the future. And I think there's some of the themes that we've been talking about for the past year or looking for. You know, the first is that, as Dan mentioned, our overall volume of engagement with HCPs has really been continuing to grow nicely quarter over quarter. which is really important to a product this early in the lifecycle, such as Epidiolex, and given that we have a number of customers have yet to use it or utilize it broadly. So, you know, promotion and education efforts are absolutely important in this highly sensitive, promotionally sensitive market that we're operating in. So that's one. I think the second driver is, as we've kind of talked about and predicted is that we're really seeing this reality of HCPs getting more experience with Epidiolex, seeing what it can do for their patients, feeling more comfortable with the product and impressed and utilizing it more broadly. Dan mentioned that quantitatively we're also seeing this in terms of market research showing that HCPs are reporting that 60% of them versus a year ago it moved Epidiolex up in their treatment algorithm. So that's working exactly as we had predicted and had been seeing early on. So lots of great momentum. And then the last one I'll point to is we've been talking all year again about our promotional focus and effort in terms of trying to get HCPs to utilize the product for the first time more and more broadly. by sharing that combination data that we have with Clobizam, it has been very impressive. It really does, you know, when they see that, you know, there's a synergistic effect of using these two products together and that most of their patients are already on Clobizam and its ability to, you know, reduce this combination seizures by 60% in LGS and Dervet, 50% in TSC, it really does give them pause. and they tell us it's highly motivating for them to either try it for the first time or to utilize it in their patients who are already on Clobazam who really could benefit from further seizure reduction. So I look at those three things really as the major things putting wind in our sails and leading to both the 22% year-over-year growth we saw in the third quarter, but also leading to the optimism that we have, you know, that this product is going to continue to grow nicely and achieve blockbuster status. And that's just the U.S., so I'll turn it over to Dan to talk about her efforts outside the U.S.
spk05: Yeah, I'll just say a few words because it's largely consistent with some of the trends and growth drivers that Kim mentioned. Just as a reminder, we're launched in 15 markets with 34 countries approved, and so there's still a series of rolling launches both geographically and also as we're adding TSC to the label in some of those markets. What we are seeing is the same HCP engagement, and it's a promotionally sensitive brand, so that's beneficial. The last major market in Europe is going to be France, and we did secure pricing and reimbursement, and we will be launching in that country where we've had a very successful sort of pre-launch experience through an ATU. So there's already awareness and patients who've been benefiting from the drug on that and sort of moving that into a full commercial launch mode by the end of the year and into a full commercial benefit for next year. So we also remain optimistic on a worldwide basis that Epidiolex can become a cornerstone of therapy for this treatment-resistant epilepsy and be a blockbuster product for us. Great. Thanks, guys.
spk17: Please stand by for our next question. Our next question comes from David Amselin with Piper Sandler. Your line is now open.
spk04: Hey, thanks. So two for me. One is on the long-term targets, the 2025 goals, one of the things you talked about is margin expansion getting I think it was near 48% or close to 50% in 25. And I'm wondering out loud, just particularly in the context of your Nibiximals commentary, how much of that expansion is expense control and particularly R&D, just putting aside in process R&D, of course, but just organic R&D? How should we think about that given that you're at about, what, 490 to 520? and your guidance this year. So that's number one. Number two is on Epidiolex, you talk about new prescriber growth. I'm just wondering if you're in a position to disclose how penetrated you are in your target audience and what's your general view regarding the pace of new prescriber growth as we move into and through 2023? Thanks.
spk16: Hi David, it's Renee. I'll take your first question in terms of margin expansion. So certainly we've been highly focused on operational excellence and yes, we have set out a 2025 adjusted operating margin ambition of being at 48%. In terms of the midpoint of our guidance today and my comments of for the full year being in a position where we're already at 49% for 2022, We've accomplished that through a number of areas. Of course, we said R&D was favorable largely due to the Nabiximals program decision as well as continued discipline. But as we look forward at what we're trying to accomplish, you know, ultimately, we're looking to better leverage SG&A overall. to be able to accommodate additional business development, to be able to accommodate additional investments in R&D in our pipeline. And so by being in the position that we are already, it gives us the opportunity to, between now and 2025, invest in our business, invest in the brands that we're launching, the pipeline, our capabilities. continue to leverage that G&A footprint as our top line grows so that we can scale effectively and efficiently, and then still have the capacity to be active in future corporate development, which of course could result in additional commercial or R&D expenses. But we certainly have a commitment to continuing to expand our R&D pipeline. We now have enhanced capabilities across the pipeline coming out of our transaction with GW. And that's an area we would expect over time will continue to generate more value for patients and for shareholders. And then I'll turn it over to Dan to answer your second question.
spk05: Yeah, thanks, Renee. So on the epidiolex, you know, we're not giving specific penetration rates, but we had said in the past that Dravet is a little more penetrated. That is a smaller indication. You know, LGS and TSC, we see Uh, more opportunity we also just see broadly that the drug works in a number of different seizure types and. There's many that make up these refractory populations that don't have FDA approved therapy. So then it's a question of. Physician use and experience and market access and. Yeah, that's all going beneficially for us as well. There's a lot of focus in terms of retention, and we've seen very strong retention. So when patients start the drug, they find this to be a very beneficial within a polypharmacy setting. We also see that as physicians gain experience and they push up the doses, that that also generally leads to better efficacy. And so continuing to titrate up, and I think in some of the markets we feel we're underdosed. So that's going to be an area of growth. And then, you know, we've got a broad indication for, you know, starting at a young age, going all the way up. And I think we've done a good job with the pediatric settings in most markets, but there's still an opportunity to transition those pediatrics as they become young adults and even adults with these lifelong conditions and also, you know, addressing the adult patient population. And then there's still, you know, additional geographic opportunities in some of the countries we haven't been in. And longer term, you know, we're investing in data generation for new seizure types such as EMAS, but we're also looking to address new significant markets like Japan and Asia.
spk03: Okay. Thank you.
spk17: Please stand by for our next question. Our next question comes from Mark Goodman with SBB. Your line is now open.
spk02: Yeah, I'm sorry to keep it on Epidiolex more, but maybe you could just help us a little bit here. You know, last year in the third quarter, it was kind of a weak quarter, and then fourth quarter was extremely strong. And so, you know, the question was there a little bit of, you know, one quarter taking away from the other, any inventory movements and stuff like that. And so... Can you help us understand if there was any of that in this quarter? Obviously, a very big quarter, and we're just trying to understand it. Maybe you can help tease out, like, is this all just European regions just getting added on, or was there actually real growth in the United States? Like, can you confirm there was double-digit growth in the United States year on year, you know, something like that? Was there any inventory change? And then just lastly, you talked about the Japan study. I was just curious, you know, before Epidiolex was approved to In the U.S. and Europe, there was a lot of CBD usage. You buy them in the bodegas. They'll be all over the place. It was just the thing to do, and it was pretty well understood. Is it the same over there in Japan? Do you expect the same type of ramp up over there and that type of excitement? Thanks.
spk10: Yeah, Mark, this is Bruce. I'll take the first part of your question and then maybe have Dan make a couple comments on Japan. It's going to be a short answer. The growth you saw in Epidiolex is real. Yes, it's in the U.S. As we continue to roll out in new countries and new indications, as Dan described, in Europe, we are seeing solid growth in the U.S., and no, it's not due to changes in inventory. Dan, you want to take Japan?
spk05: Yeah, and the Japan side, you know, we're super excited for that market and to now have launched our official study and so worked very closely with the regulatory agency and developing thought leaders who needed, you know, we're very interested in the data that was coming out of Epidiolex. But unlike other markets, there is really no cannabis allowed. In fact, there's the Cannabis Control Act, which prevents use of whether it's regulated or non-regulated. And so we're also working in parallel as GW had done successfully in other geographies with government officials to allow for exceptions to the Cannabis Control Act for regulated medicines that have gone through a safety and efficacy evaluation. And we're feeling confident we'll be able to do that change of law and sort of change of practice And then meanwhile, enroll and get the experience within Japan from the clinical studies. So that's where we are with Japan. Thanks.
spk17: As a reminder, please limit to one question. Please stand by for our next participant. Our next question comes from Amy Fadia with Needham. Your line is now open.
spk19: Thanks. Thanks for the question. My question is about Vision 2025. There's a meaningful gap between the consensus and that you're also good for 2020. Can you talk to where you think you might be more confident in the performance of the business? And to what extent do you you know, need to rely on future business development or new pipeline successes in order to be able to get to that 5 billion number. Thanks.
spk10: Yeah. Hi, Ami, and thanks for the question. I would say that, you know, even when we first communicated Vision 2025, we talked about having revenues from our existing commercial portfolio, but also including a placeholder for productivity out of our pipeline and or corp dev with a strong commitment to doing corp dev. And maybe Renee can make a few more comments about how we're thinking about that.
spk16: Sure. Yeah, I'd be happy to. Well, Ami, as we look forward, we certainly expect corporate development to continue to be an important strategic pillar for us. Clearly, it's had a huge impact on our ability to grow and diversify our revenues to date and also expand our pipeline. So as you look at the deal we just transacted on with Santa DataMap, it has the potential, as Bruce had mentioned, to contribute to Vision 2025, both as part of the $500 million placeholder we've identified from future growth and corporate development, but also as part of the five novel therapies to deliver by the end of the decade. As we look at that strategic framework for corporate development, we're looking at early assets that have the opportunity to continue to grow that pipeline, but also late molecules and then things that can also be very close to commercial, I'd put Zannie in that category in terms of being able to contribute to two different pillars. And we're excited in the case of Zannie Datomab to be a potential best-in-class therapy. This is the sort of transaction for us that we think has the potential to have a meaningful impact for patients where we can apply our unique insights, where we have the ability to commercialize efficiently given the overlap with Sepsilca. And we'll continue to look at transactions of this nature. And then I'll just note, just given our financial position right now and the speed at which we've delivered, the health of our operating cash flow, we feel confident in our ability to continue to leverage corporate development. We, of course, as we look forward, see a lot of opportunities still given valuations where they are today. and have a corporate development group that's quite busy. So we're excited about the opportunity to continue to lean into that part of our business to augment what we have already as a business. We're really excited about with the opportunities we have to grow the top line and continue to drive the pipeline forward with what we have in-house today.
spk18: Thank you. Please stand by for our next question.
spk17: Our next question comes from Ash Burma with UBS. Your line is open.
spk14: Hi. Thanks for taking my question. So on Epidiolex, I think the NCE Plus 4 timeline passed on September 28th. Can you confirm if you have visibility whether there were any paragraph for parent certification? Thanks.
spk10: Nothing to add other than we've made clear in our filings that that's the earliest filings could occur. We fully expect there may be filings over time. Of course, those go into the FDA first and come to us later, but nothing to report at this point.
spk17: Great. Please stand by for our next question. Our next question comes from Madhu Kumar with Goldman Sachs. Your line is now open.
spk06: Well, great. Thanks for taking our questions. So we are curious on how to think about kind of Zywave growth in IH and kind of how you look at the trajectory now. Do you think that there's kind of like a further upramp to happen? As you mentioned, they kind of, as physicians get more experience with Zywave and get comfortable with it, there could be like a further take up and and expansion in idiopathic hypersomnia. Like, how do you think about that?
spk10: Yeah, Kim, you want to talk a little bit about future opportunities for growth with IH?
spk20: Sure. So, lots of opportunity for growth. You know, we've talked in the past about there being already out there in the marketplace 37,000 patients who are diagnosed with IH and are actually out actively seeking healthcare. So it's not a stale diagnosis. So we've got a nice, healthy, you know, patient population to go after. You know, what we're focused on right now is really ensuring that we're educating around IH diagnosis despite this, given we really want to try to help HCPs You know, ensure that they're taking indicator saturation, the full range of symptoms that patients are experiencing. They're really used to mostly focusing on that excessive daytime sleepiness, that the, you know, off-label usage of, you know, weight-promoting agents and stimulants has been enabling them to address. And we want to make sure that they're thinking much more broadly about the breadth of symptoms that patients are experiencing and that ZyWave can treat. And then secondarily, you know, we're helping HCPs to, you know, identify patients who may be ready for Zywave. And again, a big part of that is around making sure they're thinking about that full breadth of symptoms. So, you know, overall, you know, strong excitement and feedback in the market. But as we've said, I think for a long time now, you know, idiopathic hypersomnia is a new market. Uh, and, um, you know, we're excited to build it just like we did with narcolepsy, but we expect that it will take, um, some time and, and grow gradually. Um, so, um, you know, overall, you know, lots of reasons to be optimistic, but also to, to, to appreciate, you know, jazz has, um, been working in the narcolepsy market for, you know, a decade or more now. Um, and, uh, you know, we, we plan to be, um, you know, just as successful there ultimately with, um, with ZyWave and idiopathic hypersomnia, but it will take some time.
spk10: And I'll just add that Kim mentioned narcolepsy and remember our sales force is really trying to do two things here, drive adoption in the new market of IH, but also continue our messaging to the narcolepsy community, including about the importance of the lowered sodium that we see in Zywave that led the FDA to grant the orphan exclusivity based on a safer product because of that reduction in sodium and what that can mean for cardiovascular events. So important to do that narcolepsy messaging as we continue to grow NIH.
spk06: Okay, and then in terms of corporate development, you guys have a really impressive rate of deleveraging. I guess as we think about future corporate development, will it be kind of like Ximeworks where it's kind of a partnering kind of pulling out individual assets or how you might like outright acquisitions like GW? How should we think about that on the forward?
spk16: Yeah, I'm happy to jump in.
spk10: Yeah, Renee, you want to talk about the breadth of approaches? Yeah, great. Yeah, sorry about that.
spk16: Yeah, so, you know, as I've said, corporate development will continue to be important for us and, you know, You know, as I step back and think about the opportunity, the strength of our cash flow, we generated over $930 million of operating cash in the first nine months. The fact that we delivered two full turns, and we did that through both paying down debt, we paid down over a billion dollars of debt since closing the deal, and we increased our adjusted EBITDA by more than $400 million, which is, you know, 30%, north of 30%. which means it places us in a really opportunistic position to be able to have the ability to transact at a lot of different levels. With greater EBITDA, we have greater capacity should we decide that we want to do something on the larger scale. But when we look at our business today, we think that we can continue to do transactions like the ones we did in Q2, with Werewolf and Sumitomo, two assets early in the pipeline that we're quite excited about. The Zannie deal as well being very close to pivotal data, a transaction that we think has meaningful potential to create value over time. And then looking at the strength of our cash flow combined with our expanded capabilities across you know, all aspects now and stage of our pipeline, including research capabilities, really opens up a lot of opportunity and optionality for us as we look forward. We are primarily focused in neuro and onk. We do look at other areas opportunistically. And within that, we tend to be technology agnostic, meaning between smaller, large molecules and really focus on where we think we could have the biggest impact for patients and then also for our shareholders.
spk17: Our next question comes from Balaji Prasad with Barclays.
spk03: Good afternoon. This is Xiao for Balaji. Thanks for taking our question. Just a quick one on the Zany deal. We know that the optionality for continue will be based on the BTC pivotal readout. But thinking that the BTC is a relatively small market and a bigger portion of the revenue would likely to be from other indications like GEA and breast cancer. And just wondering, is there anything you would like to highlight in terms of the read-through from the BTC pivotal data to the rest of the indications like GEA and breast cancer that you find interesting? Is timing a factor here? Thank you so much.
spk10: Yeah, maybe, Rob, I'll ask you to talk about what we think we'll learn in the near term and how we're thinking about the broader opportunity set.
spk08: Sure, Bruce, happy to. You know, what I would say before I answered the question directly is I've been impressed with the broad activity of this drug across really any tumor types that express HER2, and even in cases where patients have progressed after HER2 therapy. And so I think that speaks to the promise both in gastric and BTC, and I would say beyond. And, you know, we're doing additional studies in breast cancer and colorectal cancer, et cetera. What we'll see at the BTC readout is going to give us a sense of whether we'll have that near-term opportunity to file with BTC. And that's potentially important just even beyond the specific indication. Remember, if we get approval in a relatively small indication such as BTC, the next submission would be a supplemental. It would mean a more rapid review by FDA. It could mean that we would get NCCN guidelines around gastric based on the published data even before its approval. And it gives us a chance to do some preparation in the marketplace as well. So I think that, you know, becomes a factor in that regard. But I don't expect that it's going to have kind of a direct read through to the ongoing gastric trial.
spk03: Got it. This is very helpful. Thank you so much.
spk17: Please stand by for our next question. Our next question comes from Gary Natchman with BMO Capital Markets. Your line is now open.
spk11: Thanks. Good afternoon. Just back to Zywave. Can you confirm that the strong reimbursement that you have already locked is going to be locked in for next year? Or is there still some uncertainty there for certain payers, depending on how the generic market forms for Zyro? So how did those negotiations take place? And then generally, how much has the launch of IH helped overall awareness with narcolepsy as well, as you definitely continue to increase the number of patients treated in narcolepsy, not just in IH? Thanks.
spk10: Yeah, Kim, you want to take that?
spk20: Yeah, sure. So, in terms of 2023 coverage, I mean, what I can just say at this point in time is, you ZyWave in both narcolepsy and idiopathic hypersomnia, and we think that bodes very well for us heading into next year. I believe you asked about the authorized generic. Really, based on our conversations with payers, as well as the strong contracts that we have in place, you know, we think the most likely scenario is going to be that payers will put the AG on their formularies in a comparable position to that of Zywave. In terms of IH helping the awareness of narcolepsy, look, what I'll just say is it's not so much just around the disease, but we are out there now wherever we can with the same sales force, with the same customers, largely due to that overlap that Bruce mentioned 90% overlap, you know, with the IH targets with those that we're calling on already for narcolepsy, that we're many times getting into discussions. So, you know, we've essentially, you know, in many cases doubled the amount of promotion around the brand itself. So, I do believe that that just overall leads to, you know, momentum in both directions, you know, for both indications.
spk17: Please stand by for our next question. Our next question comes from Annabelle Samimi with Stiefel. Your line is now open.
spk01: Hi. Thanks for squeezing me in. I just wanted to ask about RILAs. When you think about the trajectory here, obviously you had a really nice uptake. I'm a little bit curious to see if this is a new peak level, obviously higher than Erwin A's. Is it going to be plateauing here given that you seem to have tap the pediatric market. You know, how should we think about growth from this point forward? You know, is it harder to get into LDL patients, AYA patients, X geographies? How should we think about the dynamic of growth? Is it a plateau or is it just a gradual growth from here?
spk10: Kim, you want to start with the U.S.?
spk20: Yeah, I'd be happy to take that one because we are incredibly pleased that, you know, Raleigh sales have exceeded prior U.S. peak sales of Erwin A's and that we believe this is, you know, a strong signal that the unmet needs of the market had never really been fully met before, you know, Erwin A's started to have supply issues. So, you know, I'll point to a number of things. You know, we now have robust brand awareness among customers and prescribers. We've created high confidence in the high quality and reliable supply of the product. And right now we enjoy the position as the only available therapy to patients in the U.S. who have a hypersensitivity reaction to E. coli-derived asparaginase. We're continuing to hear from customers that based on the availability of Rylase that they are returning to best clinical practice and switching to non-E. coli-derived asparaginase earlier. than they previously were during the supply shortage, you know, when they see an initial hypersensitivity reaction observed. At this point, Rylase has been adopted, you know, as you kind of said, almost universally in the pediatric oncology protocols. But we're also encouraged to see that there's increasing use of Rylase in the treatment of adolescents and young adults. Now, the majority of the patients out there are pediatric. And it's important to note that, you know, many adolescent and young adult patients are actually treated in pediatric centers under, you know, the really strong pediatric protocols. So that's a, you know, a good driver of the growth. Our launch was focused in the last year on establishing RILAs with our existing asparaginase prescribers who, again, were predominantly in the pediatric setting. And next year in 2023, you know, we aim to increase our efforts to driving prescribing in the adolescent and young adult population and seeing if we can, you know, further expand the market. So, again, that's just inside the U.S., and certainly there's lots of growth opportunity ex-U.S. for Dan to talk about.
spk05: Yeah, thanks, Kim. On the outside of the U.S., you know, as we've mentioned, we filed with the EMA, and we're hoping for a potential approval in the 2023, depending on how long that takes and to answer questions, et cetera. It's a different market over there, of course. Pricing is lower. And also, Erwin Ace is on the market in the European setting. That being said, the experience we've had within the US and having really optimized, particularly the Monday, Wednesday, Friday dose with a bigger dose on Friday to ensure full coverage for these patients. And then there's other advantages in terms of the concentration, the ready pill, fully recombinant, no particulates in the solution. So we do look forward to giving another treatment option to those physicians. You know, outside of Europe, there's some countries where Irwinase is not yet on the market. Japan is one. And we do, we're actively considering what the opportunity there is, and we'll be working with the regulators to see you know, is there an expedited path to get this important medicine to patients who could benefit from it?
spk17: Please stand by for our next question. Our next question comes from Gregory Renza with RBC Capital. Your line is now open.
spk13: Hey, good evening, Bruce and team. Congrats on the quarter and thanks for taking my question. Bruce, I just wanted to ask a specific one on Vixios. Perhaps you can just give us some updated color on the Vixios performance and view and trajectory from here. And maybe related to that, it's super helpful to hear Rene and the team's color elaborating on BD and Xani as a potential blueprint. I'm just curious, as you reflect on Salator from a few years ago and with Vixios now under Jazz, how that potentially juxtaposes as far as the strategy back then to how you're looking at deals like Xanny going forward. Thank you very much.
spk10: Yeah, Greg, thanks for the question. And, you know, always interesting to learn from your past corp dev deals as you consider your important strategy going forward. You know, in the Solitor deal, we brought in a near-term launch with Vixios, now on the market in the U.S. and abroad, as well as the Combiplex platform, which we continue to see as a source of other interesting products for our future development and commercialization. And I'll just remind you that Vixios remains under study in other areas inside and outside AML that we think may allow us to broaden use in the future. So, Rob, maybe talk a little bit about how Vixios is being studied right now, and then maybe, Renee, you can jump in with the prompt of, you know, how we think about different approaches to corp dev moving forward. Rob?
spk08: Sure, Bruce. Thanks. So it's being studied in a number of different ways through ISDs, collaborations with major cancer centers and cooperative groups, as well as in some ongoing studies that we're conducting. And I would just highlight a couple of things. One would be in combinations that could be highly relevant, like combinations with Phenetoclax. Those trials are ongoing. And also in trials that would seek to extend the indication to a broader group of patients, such as the cooperative group with AML-SG, which is not just the high-risk patients, but more broadly frontline.
spk16: Yeah, and then I'll just cap it out in terms of business development going forward. So, if I just look at the Xanadatomab deal in terms of how we structured it, you know, we are looking to ensure as we enter into transactions that are, you know, meeting our strategic objectives, that we're also looking to balance, you know, strike the right balance between monetary upfront financial outlays with risk and other value inflection points. Certainly with that transaction, we, are excited to be able to leverage the team at ZymeWorks in terms of continuing to drive these studies in the near term and looking at creative ways that we can continue to leverage our partners for their superpowers and skills that they're bringing to the table while also continuing to advance our strategy. And in particular with this transaction, we were pleased to be able to strike that balance with the financials and the value inflection points, not only in the upfront and how we've structured that, but also as we look forward and look at the milestones that were primarily driven by regulatory and future commercial value inflection points. So with the optionality that we have going forward, both from a financial perspective as well as having a broader business now, we'll continue to look at creative ways to structure transactions to have win-win outcomes for both Jazz and our patients and shareholders as well as our partners.
spk17: At this time, I am showing no further questions. I would now like to turn the conference back to Bruce Kozak for closing remarks.
spk10: Thanks, Michelle. So thanks for joining us, everyone. We look forward to a strong finish to 2022 and remain focused on achieving Vision 2025. And I'd just like to close today's call by recognizing our JAWS colleagues for their commitment to delivering new therapeutic options to patients and want to thank our partners and shareholders for their continued collaboration and support. Have a good evening, everyone.
spk17: This concludes today's conference call. Thank you for participating. You may now disconnect.
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