Jazz Pharmaceuticals plc (NASDAQ:JAZZ) Q1 2023 Earnings Call Transcript May 10, 2023
Jazz Pharmaceuticals plc misses on earnings expectations. Reported EPS is $3.95 EPS, expectations were $4.24.
Operator: Good day, and thank you for standing by. Welcome to the Q1 2023 Jazz Pharmaceuticals Earnings Conference Call. [Operator Instructions]. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Andrea Flynn, Vice President and Head of Investor Relations. Please go ahead.
Andrea Flynn: Thank you, operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its first quarter 2023 financial results. The slide presentation accompanying this webcast is available on the Investors section of our website. Investors may also refer to the press release we issued earlier today, which is also posted to our website. On the call today are Bruce Cozadd, Chairman and Chief Executive Officer; Renee Gala, Executive Vice President and Chief Financial Officer; Dan Swisher, President and Chief Operating Officer; and Rob Iannone, Executive President, Global Head of R&D; Kim Sablich, Executive Vice President and General Manager of United States, will join the team for Q&A. On Slide 2, I’d like to remind you that today’s webcast includes forward-looking statements, such as those related to our future financial and operating results, growth potential and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events, performance and results to differ materially from those contained in these forward-looking statements.
We urge you to review the statements contained in today’s press release, in our slide deck and in our latest SEC disclosure documents, which identify certain factors that may cause the company’s actual events, performance and results to differ materially from those contained in these forward-looking statements made on today’s webcast. We undertake no obligation to update our forward-looking statements. Turning to Slide 3. On this webcast, we’ll discuss non-GAAP financial measures. Descriptions of these non-GAAP financial measures and reconciliation of GAAP to non-GAAP financial measures are included in today’s press release and the slide presentation available on the Investors section of our website. I’ll now turn the call over to Bruce.
Bruce Cozadd: Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today. I’ll start on Slide 5. In the first quarter of 2023, we once again delivered strong commercial results, continued to advance our pipeline and built on our record operational excellence. Our results quarter underscore the durability and growth of our core commercial products and our enhanced R&D capabilities. On the commercial front, our focus on execution continues to drive key product sales, headlined by the strong performance of low-sodium Xywav. We’re especially these that physicians and patients continued to choose Xywav, even as a high sodium oxybate authorized generic, or AG, entered the market. We continue to expect that Xywav will both grow and remain the oxybate of choice in 2023, even with the availability of high sodium oxybate AG and branded fixed dose high sodium oxybate.
Xywav-active patients grew in both narcolepsy and idiopathic hypersomnia, or IH, in the first quarter. And our efforts to educate prescribers and patients about the benefits of Xywav remain effective and are resonating in the market. Xywav is now annualizing at more than $1 billion in net product sales, making our largest product by net sales. And as outlined in Vision 2025, we anticipate our oxybate franchise will generate $2 billion in revenue in 2025. We saw significant year-over-year growth in product sales for Epidiolex. Importantly, outside the U.S., we have now launched in all 5 key European markets. Demand for Rylaze remains strong in the U.S. with potential European approval later this year. Zepzelca remains the treatment of choice in second-line small cell lung cancer.
And longer term, our ongoing effort to explore Zepzelca in several new patient populations, including first-line small cell lung cancer may open up opportunities for meaningful growth. Moving to R&D. We continue to advance multiple investigational therapies in our pipeline and expect to have at least 3 late-stage readouts by the end of ’24, including JZP150 in post-traumatic stress disorder, suvecaltamide in essential tremor and Zanidatamab in first-line gastroesophageal adenocarcinoma, or GEA. On the operational side, our strong execution drove significant top and bottom line growth in the first quarter compared to the prior year. We have a business that continues to generate meaningful cash flow. In line with our disciplined capital allocation, we continue to invest in areas of our business that we believe will drive the most benefit for patients and value for shareholders, including a robust pipeline with more than 20 novel candidates across neuroscience, oncology and cannabinoids.
We are reaffirming our 2023 guidance, which Renee will discuss in more detail. Turning to Slide 6. Vision 2025 remains our strategic North Star, which we believe will deliver sustainable growth and enhanced value. We have made meaningful progress in all 3 areas of Vision 2025 and believe we are well positioned to achieve these important milestones, each of which are critical to our transformation into a high-growth global biopharma leader. I’ll now turn the call over to Dan to review our commercial performance, after which Rob will share an update on our R&D progress. Renee will provide a financial overview, and then we’ll open the call to Q&A. Dan?
Daniel Swisher: Thanks, Bruce. I’m excited to share the continued progress across our commercial portfolio. I’ll begin on Slide 8 with neuroscience and our oxybate franchise. We remain confident in the durability of our oxybate franchise and have established low sodium Xywav as the oxybate treatment of choice. Xywav became our largest product by net product sales as of the fourth quarter of 2022 and is annualizing at more than $1 billion as a result of continued adoption of both narcolepsy and IH. In the first quarter, average active Jazz oxybate patients increased to approximately 17,400 representing growth of approximately 5% and total oxybate revenues, including royalties from high sodium oxybate AG grew by approximately 6% compared to the year prior.
In narcolepsy, we continue to focus on educating patients and prescribers on the benefits of reducing sodium intake, and this message is resonating. We were very pleased with performance in the first quarter and exited 1Q ’23 with approximately 9,050 patients taking Xywav, an increase of approximately 500 patients from the fourth quarter of 2022. In IH, we see continued growth of new prescribers. And exiting the first quarter, there were approximately 2,000 IH patients taking Xywav. IH is a 24-hour sleep disorder, and Xywav is the first and only treatment-approved by FDA to treat the full condition of IH. Importantly, it has been studied across the multiple symptoms of IH. Our field force remains focused on educating prescribers on the importance of proper diagnosis and identifying appropriate patients for Xywav therapy.
And a recent Jazz survey of sleep specialists indicates that approximately 70% anticipate increasing their prescribing over the next 6 months. Slide 9 highlights the compelling low sodium health benefits we are sharing with health care professionals and patients. Narcolepsy is a debilitating chronic condition, and we have focused on education around the lifelong burden of high sodium intake for narcolepsy patients who live with an increased risk of cardiovascular comorbidities. Xywav is the only approved low sodium oxybate and has 92% less sodium than high sodium oxybates. The American Heart Association recommends a maximum of 1,500 milligrams of sodium per day, Xywav has 100 to 140 milligrams, a reduction of 1,000 to 1,500 milligrams of sodium per day compared to high sodium oxybate.
This has significant potential health benefits, including lower blood pressure and improved cardiovascular health. To add to the literature on sodium impact, we presented data at this year’s American Academy of Neurology meeting that showed narcolepsy patients treated with high sodium oxybate had a higher risk of new onset hypertension diagnosis, antihypertensive medication initiation within 180 days of starting therapy when compared to a mass control group of narcolepsy patients not being treated with high sodium oxybate. In fact, the risk of those taking high sodium oxybate was approximately twice that of the control group. With regard to oxybate competition, our high sodium oxybate AG was launched in January, and we anticipate additional AG and branded fixed dose high sodium oxybate competition in the coming months.
With competition now in the marketplace, I’ll share a few key takeaways based on our experience in the first quarter. First, we continue to build on the successful launch of Xywav. It remains the only low sodium oxybate available to patients, and we expect it to be the only oxybate indicated for IH for the foreseeable future. Second, we expect that Xywav will both grow and remain the oxybate of choice in 2023, even with the availability of high sodium oxybates. I’ll highlight that the large majority of narcolepsy patients beginning oxybate therapy in the first quarter chose Xywav over high sodium oxybate. And we expect to continue to see patients transition from both Xyrem and high sodium oxybate AG to Xywav. Third, we believe that the majority of patients and health care providers will continue to prioritize long-term health when evaluating oxybate therapy.
FDA continues to recognize 7 years of orphan drug exclusivity in July 2027 for Xywav in narcolepsy. FDA has also recognized the difference in sodium content between Xywav and Lumeris, a fixed dose high sodium oxybate, likely to be clinically meaningful in all patients with narcolepsy and that Xywav is safer than LUMRYZ in all such patients. I’ll also note that branded fixed dose high sodium oxybate has the same sodium content as Xyrem and the high-sodium oxybate AG. And Xywav is the only approved oxybate therapy that does not carry a warning and precaution related to high sodium intake. All of these factors give us confidence that Xywav is a durable product that we believe will continue to be a core growth driver for Jazz. Moving to Slide 10.
We are pleased with the continued growth of Epidiolex with net product sales in first quarter ’23 growing by 20% year-over-year to $189 million. Growth was driven by underlying demand in the U.S. and expansion to new markets outside the U.S., and we are seeing increasing use of Epidiolex earlier in the treatment algorithm. We continue to see seasonality in ordering patterns in the U.S. with a combination of a more gradual build in inventory over the second half of the year and insurance plan resets with payers impacting the first quarter, not dissimilar to what we’ve seen historically with oxybate. Turning to Slide 11. We are building on our solid foundation to capitalize on additional opportunities we see to drive Epidiolex’s growth. We’ve recently launched a number of initiatives, including educational efforts focused on optimal dose and caregiver-reported outcomes of Epidiolex treatment, including seizure, behavior and cognition data from BECOME survey.
These new initiatives are complemented by the compelling data presented last year for use of Epidiolex in combination with Clobazam. Our commercial team also has an enhanced focus on further penetration into the adult setting. We remain focused on growing Epidiolex outside the U.S. We have now launched in all 5 key European markets. And while it’s early, we are very encouraged to take in those markets, pricing and access remaining strong. Moving to Slide 12. Net product sales for Rylaze were for the first quarter, a 58% increase year-over-year. Based on the availability of Rylaze, health care providers have indicated they are returning to best clinical practice and switching therapy at the first signs of hypersensitivity. The approval of Monday, Wednesday, Friday dosing allows for a dosing schedule that is more in line with preferred clinical practice.
Rylaze has maintained strong momentum in pediatric oncology protocols and has been almost universally adopted in this setting. We are also encouraged to see that there is an increasing use of Rylaze in the treatment of adolescent and young adults or the AYA market, which is an area of increased emphasis for us in 2023. Outside of the U.S., we submitted a marketing authorization application to the European Medicine Agency in May 2022. We are also continuing to evaluate patient needs in other geographies. Slide 13 highlights that we have rapidly established Zepzelca as the treatment of choice in second-line small cell lung cancer. Zepzelca net product sales increased 13% to $67 million in first quarter ’23 compared to the same period in 2022.
Rob will discuss our development plans for Zepzelca, which also includes trials in first-line small cell lung cancer and other tumor types, providing the opportunity for meaningful future growth in new patient populations. Now I’ll turn the call over to Rob for an update on our pipeline and upcoming milestones. Rob?
Robert Iannone: Thanks, Dan. Starting on Slide 15, we’ve detailed key clinical programs in our pipeline. Our team is energized by the advances we’ve made, and we’re looking forward to late-stage data readouts from at least 3 clinical stage programs in 2023 and 2024, JZP150 in PTSD; suvecaltamide in essential tremor; and Zanidatamab or Zani in GEA. I’ll highlight several programs in more detail shortly. First, I want to touch on a few key points as we look across the breadth of the pipeline. Starting with neuroscience, development is ongoing in our Phase II PTSD trial for JZP150, with top line data expected late this year. We are also advancing trials for suvacaltumide in both essential tremor or ET and Parkinson’s disease tremor with top line data from the EP trial expected in the first half of 2024.
In our receptor agonist, or JZP441 Phase I program, we anticipate initial proof of concept in healthy volunteers this year. JZP441 has the potential to treat narcolepsy, high age as well as other sleep disorders. Moving to oncology. Zanidatamab is a priority program for us, and we are committed to bringing this novel therapy to patients. In late April, we amended our agreement remarks and are excited to welcome new colleagues who are focused on Zanidatamab work to Jazz. This allows us to benefit from their wealth of knowledge and expertise as we look to bring Zanidatamab to the market as rapidly as possible and explore other opportunities beyond BTC and GEA. For Zepzelca, we expect complete enrollment this year for the ongoing Phase III trial to evaluate Zepzelca in combination with Tecentriq in first line extensive stage small cell lung cancer.
Turning to Slide 16, I’ll discuss Zanidatamab in more detail. Zanidatamab is a novel HER2-targeted bispecific antibody with biparatopic binding and the potential to transform the current standard of care in multiple HER2-expressing cancers. As an oncologist, I’m impressed to see the monotherapy activity with Zani across multiple HER2-expressing tumor types, including cases resistant to prior HER2 therapies. The most advanced clinical work with Zani is in biliary tract cancers, or BTC, and gastroesophageal adenocarcinoma, or GEA. These are both cancers significant unmet need and poor outcomes with current standards of care. As a reminder, last year, we and our partner, Zymeworks reported positive top line results from a pivotal Phase IIb trial evaluating Zanidatamab as monotherapy in patients with previously treated HER2-amplified and expressing BTC.
In the trial, 41% of these patients with BTC achieved an objective response as assessed by blinded independent sensor review. By contrast, standard of care chemotherapy in second-line BTC would be expected to have an objective response rate of less than 10%. Currently, there are no HER2-targeted therapies approved for the treatment of BTC, and we are in dialogue with the FDA regarding the potential regulatory path forward for Zani in BTC. We’re pleased that data from this trial has been accepted as an oral presentation at ASCO this year. For those of you interested in more detail on those data, I hope you will join us for the KOL webcast we are hosting following that presentation. We are also progressing our program in GEA. At the January ASCO GI conference, the first Zanidatamab overall survival data were presented from a Phase II trial, evaluating Zanidatamab in combination with chemotherapy and first-line patients with HER2-expressing metastatic GEA.
The preliminary results show that the median overall survival had not yet been reached with an 18-month survival rate of 84%. The overall survival findings in this trial are compelling, given that the historically reported overall survival rate for the currently approved standard of care is a median of 14 months. These results show Zanidatamab’s potential as a foundational treatment for patients with HER2-positive GEA. And we look forward to additional data from the ongoing pivotal Phase III GEA trial expected to read out in 2024, which may support U.S. and global regulatory submissions. Since we acquired Zanidatamab, our confidence in this program has only grown based on positive data from both BTC and GEA. And while our initial focus is on those 2 tumor types, we believe Zanidatamab has the potential to transform the current standard of care in multiple HER2-expressing cancers.
To that end, we’re excited that Zani was added to the high spine breast cancer platform this year. In addition, we have multiple early-stage trials assessing Zanidatamab’s clinical potential in a range of tumor types and are actively evaluating opportunities to pursue additional label communications. Turning to Slide 17. I’d like to highlight suvecaltamide, which is a highly selective and state-dependent modulator of T-type calcium channels in clinical development for the treatment of essential tremor or ET and Parkinson’s disease tremor. Top line data readout for the ET trial is anticipated in the first half of 2024. So I’ll focus my comments today on that indication. There is a high unmet need for ET treatment with no new medicines approved in over 50 years.
ET can be highly debilitating with significant effects on patients’ quality of life and activities of daily living, such as eating, drinking, dressing, shaving and writing and can lead to substantial impairment on physical function. Some patients also experienced cognitive deficits, anxiety, social phobia, depression and sleep disturbances. In the U.S. and key European markets, there are approximately 2 million diagnosed patients with a prevalence estimated at 11 million. Slide 18 illustrates suvecaltamide’s differentiated mechanism of action. Though the exact line pathophysiology of ET is not clear, there is strong evidence to support the role of T-type calcium channels. T-type calcium channels regulate the balance of calcium ions, acting as a gatekeeper to help ions both enter and leave the cell membrane.
In some pathologic states such as ET, increased activation of these channels leads to excessive rhythmic signaling and prompts tremor. The high selectivity of suvecaltamide for T-type calcium channels make it a promising candidate for the treatment of ET. Importantly, suvecaltamide is differentiated from other T-type calcium channel blockers in development as an estate dependent, meaning that it targets channels under conditions of hyperexcitability, while sparing the form of the channel important for normal neuronal signaling. Slide 19 provides an overview of the suvecaltamide ET Phase IIb trial design. Approximately 400 participants with moderate to severe ET will be treated with 1 of 3 dose levels of suvecaltamide or placebo for 12 weeks.
Based on the results from our prior Phase IIa proof-of-concept trial known as T-CALM as well as FDA feedback, the primary endpoint being used in this trial is a change from baseline to week 12 on a composite of the Tremor Research Group Essential Tremor Rating Assessment scale known as TETRAS. The 2 composite measure is composed of items from 2 scales. 11 items from the TETRAS activity of daily living, which includes measures such as feeding with a spoon, hygiene and using keys; and 2 items from the TETRAS performance scale, which represent handwriting and drawing and Archimedes’ spiral, which was depicted on Slide 17. We conducted post-hoc analyses on T-CALM, which was a 4-week randomized, double-blind, placebo-controlled study to better understand the treatment effect with the TETRAS composite endpoint.
We believe that our ongoing Phase IIb trial has been optimally designed to use the Phase IIa learnings and that an appropriate patient population, primary endpoint and study duration have been selected to adequately evaluate the safety and efficacy of suvecaltamide across 3 dose levels. On Slide 20, we’ve highlighted several key aspects of our program exploring JZP150 for the treatment of PTSD, a psychiatric disorder that affects millions of people. Patients frequently have uncontrolled symptoms that impact their ability to perform activities of daily living and social function. PTSD effects up to 8% of adults during their lifetime and is associated with significant morbidity and mortality. There haven’t been any new medicines approved for the treatment of PTSD in over 2 decades.
Current standard of care includes cognitive behavior therapy with SSRIs and SNRIs used as first-line pharmacotherapy treatments. However, response rates to pharmacological treatments rarely exceed 60% and even fewer patients achieve clinical remission. JZP150 is potent, selective and irreversible inhibitor of fatty acid amide hydrolase or FAAH. This is a novel mechanism of action to potentially target the underlying pathophysiology and core symptoms of PTSD. We expect top line data from this trial late this year. Slide 21 provides an overview of our Zepzelca first-line small cell lung cancer program. Small cell lung cancer patients have particularly poor outcomes with a 5-year overall survival rate of less than 10%. Currently, Zepzelca is indicated to treat patients in the second-line setting, but we see a clear mechanistic rationale for Zepzelca can potentially increase the duration of response in the first line setting as maintenance therapy in combination with the standard of care, which is chemotherapy plus a PD-L1 inhibitor.
We have an ongoing first-line trial being run in collaboration with Roche to evaluate Zepzelca in the setting with chemotherapy plus Tecentriq or atezolizumab. The trial design is outlined on the bottom portion of the slide, and we expect to complete enrollment by the end of the year. Now I will turn the call over to Renee for a financial update. Renee?
Renee Gala: Thanks, Rob. I’ll start with our top and bottom line results on ’23. As a reminder, our full financial results are available in our press release and 10-Q. In the first quarter of 2023, we recorded impressive year-over-year revenue of 10%, achieving $893 million in total revenues. This was driven by growth of our key products in both neuroscience and oncology, including year-over-year double-digit growth of Xywav, Epidiolex and Rylaze. Our disciplined capital allocation and focus on operational excellence drove adjusted net income of $285 million, growing broadly in line with our revenues compared to the same period in 2022. We continue to generate significant cash from our business, recording more than $300 million of cash from operations in the first quarter of 2023, an increase of 53% compared to the first quarter of 2022.
With healthy cash flows and a strong balance sheet, we have strategic flexibility to invest in growth drivers within our current business as well as corporate development opportunities. Corporate development is an important component of Vision 2025, and we are actively assessing opportunities that we believe will deliver innovation for patients and contribute to building a sustainable business that provides meaningful returns to shareholders. Turning to Slide 24. We are reiterating the 2023 revenue guidance we provided in March. We are executing in line with our expectations and are confident in meeting those targets. The guidance reflects our strong performance in the first quarter, our expectations around the durability of our oxybate franchise and anticipated growth across our key products.
Our total revenue guidance range for 2023 is $3.675 billion to $3.875 billion, positioning us for year-over-year total revenue growth. Our 2023 guidance for neuroscience of $2.675 billion to $2.825 billion incorporates expected growth for both Xywav and Epidiolex as well as the continued decline in Xyrem due to robust Xywav adoption and the introduction of competitive high sodium oxybates. As a reminder, our neuroscience guidance also includes high sodium oxybate AG royalties, which are recognized within total revenues under royalties, not under neuroscience net product sales. Due to the royalty structure within our AG agreement with Hikma, we expect our royalties to be significantly higher in the second half of 2023 relative to the first half.
As a reminder, in the first half of 2023, while Hikma maintains exclusive rights to distribute high sodium oxybate AG, the royalty rate paid to Jazz is tiered and wide ranging, starting at 10% and going all the way to 90% based on the volume of AG units sold as a percentage of total oxybate units, with the total referring to Xywav, Xyrem and high sodium oxybate AG. During the second half of 2023, the royalty rate to Jazz becomes fixed at a rate where we and Hikma both have substantial economics regardless of the AG volumes. Our oncology guidance reflects expectations of continued double-digit growth for this franchise with a revenue range of $950 million to $1.05 billion, resulting in a midpoint of $1 billion. Continuing on Slide 25, our SG&A guidance for 2023 is a reduction compared to 2022, and we are tracking through the first quarter as expected.
As we noted in our last quarterly update, our R&D guidance of $700 million at the midpoint represents enhanced investment over 2022, reflecting the growth and maturation of our pipline, as Rob noted earlier in the call. On the bottom line, we expect to continue to deliver strong adjusted net income with 37% growth at the midpoint and a guidance range of $1.24 billion to $1.31 billion. The midpoint of our financial guidance imply an adjusted operating margin of approximately 46% for the year. We’ll continue to prioritize commercial, R&D and corporate development efforts that we believe will deliver the most value, leveraging our cash generation to invest in our business, improve our bottom line and deliver strong shareholder returns. With our strategic investments, expanding product portfolio, R&D progress and focus on operational excellence, we believe we are well positioned to achieve Vision 2025.
And deliver further diversification, sustainable growth and enhanced value to patients and to shareholders. I’d now like to turn the call back to Bruce.
Bruce Cozadd: Thanks, Renee. I’ll conclude our prepared remarks on Slide 27. We started 2023 with significant momentum, and I’m pleased to report that we’ve continued making strong progress in the first quarter of 2023. On the commercial front, we’ve successfully launched multiple products over the past several years, which are now demonstrating strong and durable performance. Our pipeline is more robust than it’s ever been in the company’s history. And we have at least 3 anticipated late-stage data readouts through 2024 that have the potential to continue to diversify and transform our business. We also remain focused on strategic capital allocation. With our strong cash flow, balance sheet and margins, we have the flexibility to make significant investments across commercial, pipeline and corporate development to drive sustainable growth and enhanced value.
That concludes our prepared remarks. I’d now like to turn the call over to the operator to open the line for Q&A.
Q&A Session
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Operator: [Operator Instructions]. And our first question comes from the line of Jessica Fye with JPMorgan.
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Operator: And we have no further questions at this time. I will now turn the call back over to Bruce Cozadd.
Bruce Cozadd: All right. Thanks, operator. So just to wrap, thanks for the wide-ranging questions. I think we hit pretty much all the key topics that we covered in our news release, in our script. I don’t think we got many questions on oncology. I’ll just reiterate, we’re really excited for the growth of our oncology franchise led by Rylaze and Zepzelca. And didn’t get many questions on Zanidatamab, but lots of news upcoming there with additional clinical data presentations. And we’re looking forward to progress that program rapidly. Most important, we’re continuing to be focused on Vision 2025. Remember that we’ve got upcoming Phase IIb Zanidatamab BTC data at ASCO in June. That’s the first time Zani findings are going to be featured during an oral session at a major oncology conference.
And immediately after the presentation, we’re hosting a webcast where Dr. Shubham Pant, who is presenting the data at ASCO will review findings. We’re also presenting multiple data sets at this year’s American Academy of Sleep Medicine Annual Meeting [indiscernible] at ASCO or sleep, we may see you there. Also note, we’re participating in the upcoming RBC Investor Conference on May 16. Let me close today’s call by recognizing our Jazz colleagues for their work to deliver new therapeutic options to patients. And I want to thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today.
Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect.