Earnings call transcript: Jazz Pharmaceuticals Q4 2024 beats EPS forecasts

Jazz Pharmaceuticals (NASDAQ:JAZZ) reported its Q4 2024 earnings on February 25, surpassing analyst expectations with an earnings per share (EPS) of $6.60, compared to the forecasted $5.79. The company’s revenue for the quarter reached $1.1 billion, exceeding the anticipated $1.06 billion. According to InvestingPro analysis, Jazz currently appears undervalued based on its Fair Value estimate, with impressive gross profit margins of 92.62%. Despite the positive earnings surprise, Jazz Pharmaceuticals’ stock experienced a 1.55% decline in after-hours trading, closing at $137.50.

Key Takeaways

• Jazz Pharmaceuticals’ Q4 EPS of $6.60 beat the forecast by 14%.
• Revenue for the quarter reached a record $1.1 billion.
• Stock declined 1.55% in after-hours trading despite strong earnings.
• The company expects 2025 revenue growth of 5%, reaching $4.15-$4.4 billion.
• Jazz Pharmaceuticals made significant progress with its product portfolio, including FDA approval for Xyhara.

Company Performance

Jazz Pharmaceuticals delivered robust financial results in Q4 2024, driven by strong performance across its product portfolio. The company reported total annual revenue of $4.1 billion, reflecting a 6% year-over-year growth. With an overall financial health score rated as "GREAT" by InvestingPro, and a strong current ratio of 4.26, Jazz demonstrates solid financial stability. This performance underscores Jazz’s strategic focus on its key therapeutic areas: sleep, epilepsy, and oncology, each contributing over $1 billion annually. InvestingPro subscribers have access to 12 additional key insights about Jazz’s financial health and market position through the comprehensive Pro Research Report.

Financial Highlights

• Revenue: $1.1 billion in Q4 2024 (highest ever for the company)
• Non-GAAP adjusted net income: $1.37 billion for the year
• Non-GAAP adjusted EPS: $20.90 for the year
• Cash from operations: $1.4 billion
• Cash on hand: $3 billion

Earnings vs. Forecast

Jazz Pharmaceuticals exceeded expectations with an EPS of $6.60, surpassing the forecast of $5.79 by 14%. The revenue of $1.1 billion also outperformed the anticipated $1.06 billion, marking a significant achievement for the company in its highest-ever revenue quarter.

Market Reaction

Despite the earnings beat, Jazz Pharmaceuticals’ stock fell 1.55% in after-hours trading, closing at $137.50. This decline may reflect investor caution or profit-taking following the stock’s recent gains. The stock remains near its 52-week high of $140.52, with analyst price targets ranging from $140 to $230. InvestingPro data shows the company maintains a healthy free cash flow yield of 13%, suggesting strong cash generation capabilities.

Outlook & Guidance

Looking ahead, Jazz Pharmaceuticals projects 2025 revenue to be between $4.15 billion and $4.4 billion, indicating a 5% growth. The company plans to reduce R&D spending by 8% to focus on strategic investments in neuroscience, oncology, and rare diseases.

Executive Commentary

CEO Bruce Kozad highlighted the company’s achievements, stating, "2024 was a record year for Jazz." CFO Phil Johnson emphasized financial strength, noting, "We continue to generate significant cash from our business." Rob Noane, Head of R&D, expressed optimism about zanidetimab, calling it a "potential best-in-class HER2 targeted therapy."

Risks and Challenges

• Market saturation in key therapeutic areas could limit growth.
• Potential supply chain disruptions may impact product availability.
• Regulatory challenges in new markets could delay product launches.
• Macro-economic pressures could affect healthcare spending.
• Competitive pressures from new entrants in the pharmaceutical market.

Q&A

During the earnings call, analysts inquired about Jazz Pharmaceuticals’ M&A strategy and financial flexibility. The company’s leadership elaborated on the Epidiolex settlement and provided insights into oxibate market dynamics, emphasizing a continued focus on pipeline prioritization and R&D investments.

Full transcript - Jazz Pharmaceuticals PLC (JAZZ) Q4 2024:

Conference Operator: Thank you for standing by. My name is Jeannie and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals Fourth Quarter twenty twenty four Webcast.

All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question and answer session. Thank you. I would now like to turn the call over to Jeff McDonald, Executive Director, Investor Relations. You may begin.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals: Thank you, operator. Good afternoon, everyone. Today Jazz Pharmaceuticals reported its fourth quarter and full year twenty twenty four financial results. The slide presentation accompanying this webcast is available on the Investors section of our website as is the press release we issued earlier today. On the call are Bruce Kozad, Chairman and Chief Executive Officer Renee Galla, President and Chief Operating Officer Robbie Noane, Executive Vice President, Global Head of R and D and Phil Johnson, Chief Financial Officer.

On Slide two, I’d like to remind you that today’s webcast includes forward looking statements such as those related to our future financial and operating results, growth potential and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events, performance and results to differ materially from those contained in these forward looking statements. We encourage you to review the statements contained in today’s press release in our slide deck and the risks and uncertainties described under the caption Risk Factors in our annual report on Form 10 ks for the fiscal year ended 12/31/2023, our quarter report on Form 10 Q for the quarter ended 09/30/2024 and our subsequent filings with the SEC including our annual report on Form 10 ks for the fiscal year ended 12/31/2024, which identified certain risk 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 webcast. We undertake no duty or obligation to update these forward looking statements. As noted on slide three, we will discuss non GAAP financial measures on this webcast. Descriptions of these non GAAP financial measures and reconciliations 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 Kozad, Chairman and Chief Executive Officer, Jazz Pharmaceuticals: Thanks, Jeff. Good afternoon, everyone. Thank you for joining us today to discuss Jazz’s fourth quarter and full year 2024 results. I’ll start on Slide five. I’m very pleased to report that 2024 was another record year for Jazz.

Our strong commercial execution resulted in more than 4,000,000,000 in total annual revenue and fourth quarter revenue of nearly $1,100,000,000 our highest ever. Importantly, we helped more patients who benefit from our highly differentiated therapies in areas with limited or no therapeutic options. These achievements reflect the tenacity and dedication of our talented employees around the world. On the R and D front, we achieved several important development and regulatory milestones in 2024, headlined by the accelerated approval of CYHARA in The U. S.

For the treatment of second line HER2 positive biliary tract cancer or BTC in November. In addition, we believe the positive results from the Phase III Zepsilka clinical trial in first line maintenance for small cell lung cancer will support expansion into an earlier line of treatment potentially benefiting a broader patient population. We plan to further diversify our commercial and pipeline portfolios through strategic corporate development, which remains a key focus for Jazz. As part of our ongoing search, we’re evaluating neuroscience and oncology assets, while also contemplating other rare and orphan diseases. In addition, durability of revenue, efficiency of commercial call points and alignment with our expanded R and D capabilities are part of our considerations as we assess opportunities to maximize long term shareholder value through corporate development.

Turning to slide six, I’m pleased to confirm we achieved our 2024 guidance, delivering top line growth at the upper end of our range and $1,370,000,000 in adjusted net income on a non GAAP basis. Phil will discuss our 2024 financial results and 2025 guidance in more detail later in the call. On the commercial front, our sleep, epilepsy and oncology portfolios are each annualizing at over $1,000,000,000 based on fourth quarter net product sales. Zywave remains the number one branded treatment for narcolepsy based on revenue and the only FDA approved therapy to treat idiopathic hypersomnia or IH. We’ve been pleased with our execution across narcolepsy and IH as our team has navigated the entry of high sodium, fixed dose branded oxivate and authorized generic or AG competition since their introduction in 2023.

Epidiolex net product revenues grew 15% in 2024 compared to 2023 and it is poised to reach blockbuster status this year. Oncology revenues grew 9% in 2024 to a record of more than $1,100,000,000 even with changes to pediatric protocols, which temporarily impacted Riley’s revenue in the second half of twenty twenty four. Renee will discuss our commercial performance in greater detail. Overall, our 2024 total revenue grew 6% compared to 2023, reflecting our strong execution of the commercial strategies we are implementing. We continue to advance promising opportunities in our pipeline.

We look forward to the data readout from the Horizon GE A01 Phase three trial evaluating sanidatumumab in first line gastroesophageal adenocarcinoma or GEA. While we had previously provided an estimate of the second quarter of this year for top line progression free survival readout, based on our more mature projections of events accrued to date, we now expect data readout in the second half of this year. Rob will share additional color on this trial a bit later in the call. The first line BTC confirmatory trial, Phase III breast cancer trial and Phase II pan tumor trial are all progressing well. In addition, we plan to submit a supplemental new drug application or sNDA for Zepsilka as maintenance therapy in first line extensive stage small cell lung cancer in the first half of twenty twenty five.

We remain focused on driving growth while maintaining a disciplined and strategic approach to capital allocation. Our financial strength and cash flow enable us to invest in our commercial portfolio, pipeline and future corporate development opportunities. Before we move on, as previously shared, I’ll be retiring from my role as CEO this year. It’s been a privilege to lead Jazz through the growth and significant diversification that has transformed the business into the fully integrated biopharma company it is today. Importantly, we remain committed to reaching more patients by making strategic investments through corporate development, a focus that will continue during the CEO transition period.

After a successor is appointed, I’ll continue serving as Chairman of the Board of Directors, providing ongoing leadership and strategic guidance. I’m confident Jazz’s next leader will continue delivering for patients, employees, partners and shareholders. I’ll now turn the call over to Renee to discuss our commercial performance, after which Rob will cover our R and D pipeline. Phil will then provide a financial overview and review our 2025 guidance, and then we’ll open the call for Q and A. Renee?

Renee Galla, President and Chief Operating Officer, Jazz Pharmaceuticals: Thanks, Bruce. Before I cover individual commercial products, I’d like to thank the Jazz team for their tremendous efforts across the year, which resulted in each of our promoted commercial products achieving their highest ever annual revenues in 2024. Beginning on Slide eight and our sleep portfolio, our focused efforts to educate physicians and patients on the benefits of Zywave, including the importance of meaningfully reducing sodium intake continue to resonate in the market. We view every high sodium oxybate patient as one who could benefit from low sodium sideways as people living with narcolepsy are at a two to three times higher risk of cardiovascular comorbidities such as stroke and heart failure than the general population. In addition, results from the RYTHM study demonstrated patients with IH experienced a higher likelihood of co morbid conditions across multiple clinical categories, including cardiovascular conditions.

There were approximately fourteen thousand one hundred and fifty patients taking XY Wave exiting 2024, representing approximately eighteen fifty net patient adds compared to the end of twenty twenty three. In the fourth quarter, there was a meaningful increase of approximately five twenty five net patient adds comprised of one hundred and seventy five narcolepsy patients and three fifty IH patients. Total (EPA:TTEF) sleep revenue, which includes Zywave and Xyrem net product sales, plus royalties from high sodium oxybate AG, was $5.00 $6,000,000 in the fourth quarter and exceeded $1,900,000,000 for the full year. Zywave net product sales grew 16% year over year to approximately $1,500,000,000 in 2024 and were $4.00 $1,000,000 in the fourth quarter of twenty twenty four. The initiatives we implemented at the end of twenty twenty three and throughout 2024, including field force expansion, digital and media campaigns and the field nurse educator program coupled with our JazzCare services contributed to both patient demand and persistency across narcolepsy and IH.

We believe the IH market we are building with the first and only FDA approved therapy to treat IH represents the most opportunity for patient growth and is a durable segment of our sleep portfolio. Our field team continues to expand the breadth and depth of HCP’s prescribing XY Wave for IH by highlighting the significant unmet patient needs and the benefits of treating multiple symptoms of IH with XY Wave. On Slide nine, we turn to Epidiolex with net product sales of $275,000,000 in the fourth quarter, representing a 14% increase compared to the same quarter in 2023. For the full year 2024, Epidiolex revenue was approximately $972,000,000 up 15% year over year, primarily driven by underlying demand. Key drivers of demand growth in The U.

S. Included continued positive response to data on the benefits of Epidiolex beyond seizure control, reaching adult patients and long term care facilities along with broad quality access. In December, we presented nurse reported responses to the BECOME survey in long term care facilities that showed Epidiolex treatment was associated with an overall reduction in seizure frequency and improvements in patients’ abilities such as communication, cognition and emotional functioning. We expect this continued data generation and increased penetration in the adult patient setting and long term care facilities will drive demand. Growth in the adult patient setting is supported in part by data showing many LGS patients reach adulthood without a specific LGS diagnosis and by providing healthcare professionals with clear diagnostic tools to identify adult LGS patients.

Further, we believe Epidiolex is a durable, long lived asset and I’m pleased to share we recently settled with all 10 current ANDA filers. Under the settlement agreements, we granted each of those ANDA filers a license to manufacture, market and sell its own generic version of Epidiolex beginning in the very late 2030s or earlier under certain circumstances. We’re pleased with the momentum and growth of Epidiolex and expect it to reach blockbuster status in 2025. Moving to oncology on Slide 10. Rylase net product sales were approximately $101,000,000 for the fourth quarter twenty twenty four and approximately $411,000,000 for the full year, representing a 4% year over year increase compared to full year 2023.

In our third quarter earnings, we reported a temporary negative impact to Rylase revenue due to an update to Children’s Oncology Group pediatric treatment protocols for acute lymphoblastic leukemia or ALL. This update impacts the timing of asparaginase administration, pushing back the use of Rylase by ten weeks. It’s important to note the protocol changes do not change the recommended total number of asparaginase doses and we don’t anticipate an impact to underlying demand for Rylase. Revenues are still expected to normalize early this year. We see the most opportunity for growth in the adolescent and young adult or AYA market and we are continuing to educate oncologists who treat these patients on the benefits of asparaginase therapy.

On Slide 11, I’ll discuss Sapsulka.Net product sales for the full year 2024 were approximately $320,000,000 up 11% year over year. In the fourth quarter, Zepsilka net product sales increased 6% year over year to approximately $78,000,000 Zepselka remains the treatment of choice for second line small cell lung cancer and we continue to hear positive feedback from physicians on its clinical benefit and ease of use and administration for patients in their healthcare practices. Expansion into first line maintenance therapy for extensive stage small cell lung cancer represents an opportunity to extend the duration of treatment while reaching patients earlier in their disease progression. We plan to submit an sNDA for Zepsilka in this indication in the first half of this year. Moving to Slide 12 to cover Xyhara.

We had an exciting fourth quarter with the FDA approval of Xyhara, the first and only dual HER2 targeted bispecific antibody approved for HER2 positive second line BTC in The U. S. Our experienced oncology team swiftly initiated the commercial launch of Xyhara following approval and I’m pleased to share that the first BTC patient was treated with CyHara in December. We recognized approximately one million dollars of net product sales in 4Q twenty twenty four. The initial reception from HCPs has been positive and we have the right capabilities and infrastructure to deliver a successful launch of Xyhara in second line HER2 positive BTC.

Physicians currently diagnosing and treating BTC patients significantly overlap with our existing Xepselka call universe, positioning us to leverage our current footprint to help accelerate the launch and uptake of Xyhara for second line HER2 positive BTC. Xyhara has the potential to deliver greater efficacy outcomes compared to the current standard of care for BTC, while providing better tolerability and safety to maximize patient outcomes and benefit. Although BTC represents a small patient population, this initial launch will help establish Sahara with healthcare professionals and allow them to get meaningful experience with it. With that, I’ll turn it over to Rob for an update of our pipeline and upcoming milestones. Rob?

Rob Noane, Executive Vice President, Global Head of R&D, Jazz Pharmaceuticals: Thanks, Renee. I’ll begin on Slide 14. We achieved an important milestone for patients and our company in 2024 with the FDA approval of zanadetimab in second line BTC, along with the initiation of our first line BTC confirmatory trial. Beyond BTC, we significantly advanced zanadetimab development, including our ongoing first line GEA trial and the initiation of the Phase III EMPOWUR breast cancer trial and Phase II pan tumor trial. As Bruce mentioned earlier, we are now expecting the top line PFS readout from our Phase III frontline DEA trial evaluating zenodetimab with standard of care chemotherapy with and without the addition of a PD-one agent in the second half of twenty twenty five.

Recruitment for this trial is on track and we expect to complete enrollment within the next few weeks. As a reminder, this is an events driven trial and our updated estimate is based on a more mature projection of progression events relative to the initial protocol assumptions. While we as the sponsor remain blinded to the results of the trial, we are encouraged by the positive results from two independent Phase II trials of zanodetimab and first line that have demonstrated increased median PFS, duration of response and confirmed objective response rates. If positive, we expect the PFS data from this trial will support registration. Moving to other programs.

In October 2024, we reported highly encouraging results from the Phase III EMMORTAE trial of ZYBSELCA in combination with atezolizumab compared to atezolizumab alone when administered as maintenance therapy in first line extensive stage small cell lung cancer. The combination demonstrated statistically significant and clinically meaningful improvements in the primary endpoints of overall survival and progression free survival. The results have the potential to be practice changing and we look forward to presenting the data at a medical meeting this year, which is an important step toward potential inclusion in NCCN guidelines and compendia listings. As Renee mentioned, we plan to submit an SNDA to FDA in the first half of twenty twenty five to expand the ZYPTELCA label to include first line maintenance. The EPIDIOLEX trial in Japan remains ongoing as we collect long term safety data, which was included in the trial design for twenty six and fifty two week analyses.

Numeric improvements were observed in the primary and several secondary endpoints and we expect to have substantive discussions with PMDA by mid-twenty twenty five. Turning to slide 15, I’ll review the unique clinical profile of Zaihara for zanaditumab and why we believe it has the potential to become the HER2 targeted agent of choice. ZenaDatumap has demonstrated activity in multiple HER2 expressing cancers. Its bipartopic binding results in multiple mechanisms of action, all resulting in tumor cell death. ZEMI has been shown to interfere with HER2 signaling, which also disrupts heterodimerization of HER2 and HER3, further inhibiting tumor cell signaling and growth.

Zana data map also causes receptor clustering and internalization inducing immune destruction through ADCC, ADCP, and CDC. We think that zanidatamab induces complement dependent cytotoxicity at a level that is highly differentiated in the category. Zanidatamab’s profile includes established safety and tolerability, ease of administration, single agent activity without chemotherapy and it combines well with other therapies including chemotherapy. We believe zanaditumab has the potential to be a best in class HER2 targeted therapy for multiple HER2 positive solid tumors. Importantly, DIHARA was added to the NCCN and ESMO guidelines for biliary tract cancer after approval as part of an off cycle review, highlighting the meaningful advance IHARA represents for HER2 positive BTC patients.

Slide 16 highlights the potential for zanaditumab in BTC and beyond. In addition to FDA approval for BTC, the European Medicines Agency validated the marketing authorization application for zanidetimab in second line BTC in 2024. And we await potential approval as early as 2Q twenty twenty five. We’ve already discussed the opportunity we are pursuing in GEA. Additionally, we initiated the Phase III EMPOWUR trial, which is designed to evaluate savadetumab in combination with chemotherapy in breast cancer patients who have progressed on or are intolerant to in HER2.

With this ongoing Phase III trial, we have the opportunity to be the first HER2 targeted therapy to demonstrate efficacy and safety in breast cancer patients post in HER2. We also have multiple ongoing trials in early stage breast cancer including through our collaboration with MD Anderson Cancer Center and the iSPITE program. Venadimab monotherapy has shown promising activity across a range of tumor types And we initiated a Phase II pan tumor trial to generate additional data across a variety of HER2 expressing solid tumors. Overall, we are incredibly excited about the opportunity that zavodetimat represents for patients with HER2 expressing tumors. Now, I will turn the call over to Phil for a financial update.

Phil?

Phil Johnson, Chief Financial Officer, Jazz Pharmaceuticals: Thanks, Rob. I’ll start with our top line results on Slide 18. As a reminder, our full financial results are available in today’s press release and in our 10 K, which will be filed tomorrow morning. In the fourth quarter of twenty twenty four, we achieved nearly $1,100,000,000 in total revenues. We were pleased to deliver this top line growth, which was driven by increased XY wave, Epidiolex and Oncology revenues.

And for full year 2024, we recorded approximately $4,100,000,000 in total revenues, representing six percent growth over 2023. This marks our twentieth consecutive year of top line growth. And as you’ve seen in our guidance, we expect 2025 to be our twenty first consecutive year. Turning to Slide ’19, our full year 2024 non GAAP adjusted net income was approximately $1,370,000,000 and we reported non GAAP adjusted EPS of $20.9 We continue to generate significant cash from our business, demonstrating the strength and diversity of our portfolio. We recorded approximately $1,400,000,000 of cash from operations for the full year 2024 and ended the year with $3,000,000,000 in cash on hand.

Consistent with our prior communications, in January, we made a voluntary repayment of $750,000,000 to reduce the principal amount of our term loan B. During 2024, we continue to utilize our share repurchase authorization and spend approximately $311,000,000 repurchasing shares. Going forward, if not used for corporate development investments to enhance our future growth prospects, we expect a significant portion of free cash flow to go toward debt pay down, share repurchases or some combination thereof. Finally, our overall financial position and robust operating cash flows provide significant flexibility to invest in value driving commercial and R and D programs as well as in promising corporate development opportunities. We’re pleased to share our full year financial guidance for 2025 beginning on Slide 20.

Our 2025 total revenue guidance range of $4,150,000,000 to $4,400,000,000 represents 5% year over year top line growth at the midpoint, driven by our diversified commercial portfolio, expanding sleep, epilepsy and oncology. Top line growth in 2025 is underpinned by our expectation of continued growth of XY Wave, Epidiolex reaching blockbuster status and the assumption that high sodium oxymorbid AG royalty revenue will continue for the full year. As a reminder, if Hikma and others enter the market with true generics, our AG royalty revenue will go away and we could have rapid erosion of remaining Xyrem revenue. While we believe we’ll be well positioned with the XYwave given it’s not AD rated to all other high sodium oxybates, including generics, the impact of true generic XYrem on XYwave revenue is uncertain and will depend on a number of factors such as the continued recognition by HCPs, patients and payers of the value of low sodium. Other dynamics we anticipate throughout the year include a continued decline of Xyrem revenue and normalization of Rylase revenue early this year.

We anticipate modest revenues from Xyremia given the small BTC patient population, although a successful BTC launch is key to providing HCPs with valuable experience with Xyremia ahead of the potential launch in GEA. Finally, while we don’t provide quarterly guidance, I do want to note our first quarter revenues have historically been affected by several factors, including reauthorizations and inventory build in the latter part of the prior year, which can contribute to lower revenues in the first quarter compared to other quarters. Now I’d like to draw your attention to several items on Slide 21. With regard to operating expenses, our non GAAP adjusted SG and A guidance range is $1,250,000,000 to $1,310,000,000 The increase in non GAAP adjusted SG and A reflects continued investment in our lead commercial products. We remain focused on operational excellence and continued execution of the commercial initiatives from last year to further drive growth of our diversified portfolio.

Our non GAAP adjusted R and D guidance range of $720,000,000 to $770,000,000 represents an 8% decrease from 2024. We’re continuing to focus investments on priority programs, including the broad sandidatumab development program that has the potential to positively impact many patients and deliver significant shareholder value. The decrease in 2024 is primarily driven by a reduction in clinical studies and outside service costs relating to JCP385 and continued portfolio prioritization. On the bottom line, we expect adjusted net income in 2025 to be $1,400,000,000 to $1,500,000,000 This reflects our expectation of continued strong commercial performance and disciplined expense management, while continuing to invest in our highly differentiated commercial portfolio and pipeline. I’ll now turn the call back to Bruce for closing remarks.

Bruce Kozad, Chairman and Chief Executive Officer, Jazz Pharmaceuticals: I’ll conclude our prepared remarks on Slide ’23. ’20 ’20 ’4 was a record year for our promoted commercial products and we expect to deliver continued strong execution in 2025. Epidiolex remains poised to reach blockbuster status in 2025 and we expect Cywave to remain the number one branded narcolepsy treatment with continued growth in IH. CyHera represents a significant growth opportunity with an estimated $2,000,000,000 plus in peak sales potential. We look forward to submitting the sNDA for Zepsilka with the potential to help more patients for a longer duration and extend survival.

Our proven strength in commercial and pipeline execution and corporate development are supported by our continued focus on operational excellence and strategic capital allocation. I’m confident Jazz is well positioned to deliver our twenty first consecutive year of top line growth in 2025, drive meaningful shareholder value with data readouts such as the Phase III GEA trial and pursue strategic corporate development opportunities to deliver long term sustainable growth. That concludes our prepared remarks. I’d now like to turn the call over to the operator to open the line for Q and A.

Conference Operator: Thank you. We will now begin the Q And your first question comes from the line of Mark Goodman with Leerink. Please go ahead.

Speaker 6: Hey, Rob. Can you talk about the Oraxin four forty one? Any type of comment you can make? Have you figured out the safety margin? Is your low dose kind of doing what you wanted to do?

Any comments there would be helpful. And then just on the settlement with Epidiolex, is there any reason you’re being so cagey? Can you actually give us the date? Thanks.

Speaker 7: So, Mark, this is Bruce. Maybe I’ll jump in on your second question first. We actually think saying our Epidiolex settlements with all 10 ANDA filers go out to the very late 2030s is being pretty specific. I’ll remind you those agreements have confidentiality provisions, which limit what else we can say. So, that’s all we’re going to have to say at the moment is very late 2030s.

Rob, I’ll kick it over to you for a 04:41 update.

Rob Noane, Executive Vice President, Global Head of R&D, Jazz Pharmaceuticals: Thanks, Bruce. So, Mark, we don’t have an update on the trial that we said we are initiating. This is a trial with four forty one in NT1 patients, small number, we thought about 10 or so. But so far no updates on that. But we do think that even in a small number of patients that will help us to find a better therapeutic index.

No updates at this time.

Conference Operator: Your next question comes from the line of Jessica Fye with JPMorgan. Please go ahead.

Speaker 8: Hey guys, good afternoon. Thanks for taking my questions. For the Horizon GEA trial, I think you said you’ll complete enrollment in the next few weeks. So just to confirm, is that for the upsized nine eighteen patient target enrollment? Can you remind us when you completed enrollment of the originally planned seven fourteen patients?

And then I guess while I’m at it on this trial, Rob, when you see the event rate maturing differently than initially projected as it seems to be here, do you take that as positive, neutral or negative for probability of success? Thank you.

Speaker 9: Go ahead, Rob.

Rob Noane, Executive Vice President, Global Head of R&D, Jazz Pharmaceuticals: Okay. Hi, Jess. So we are referring to the nine eighteen when we say we’ll be completing enrollment in the coming weeks. We hadn’t said when the seven fourteen was enrolled. As you know, we are blinded to the results of the trial.

And so we can’t say what’s driving the slower accrual of events, whether that’s coming from control arm or the experimental arms. Generally speaking, it certainly could be a good thing that the experimental arms are having a significant effect and pushing that out. But we don’t see the data, so we don’t know for sure. I would say that, the control arm certainly could be behaving differently than prior trials. However, we’ve seen three Phase III trials in this setting and the control arm has been pretty consistent across those.

So I don’t expect a big surprise on the control arm. But again, we are blinded to that information. We have an external vendor who is tracking events and gives us periodic updates. But as we’ve said, we’re confident in the second half of this year. Depending on how the events continue to roll in, that certainly could come in 3Q.

Conference Operator: Your next question comes from the line of Jason Gerberry with Bank of America. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals0: Hey guys, thanks for taking my question. Mine’s just on M and A. You guys seem to be flagging that again this year. And I guess it’s been a dominant part of the Jazz investor discussion for a while now, but you really haven’t like swung the bat in a big way since GW. And so I’m just kind of curious maybe why that is, ultimately if you can reflect upon that.

And then with this Epidiolex patent settlement in place and now having a runway on a $1,000,000,000 franchise plus well into the next decade, just how does that alter how you guys think about M and A, having that longevity of assets now?

Speaker 7: So, Jason, this is Bruce. I’ll jump in with a little historical perspective and then maybe I can have Phil, give you a more forward looking view. Just as a reminder, we completed the GW acquisition in May of twenty twenty one, and levered up to some degree to do that and spent some time after that bringing leverage back down quickly and considerably. And during that period, we were, needless to say, not pursuing larger transactions as we had forecast. To say we haven’t done anything, I think, would forget that we did the Zany DataMap transaction, which, while it had a smaller upfront, certainly has been a major focus for us in terms of value creation potential for the company.

We remain excited about it. Phil, maybe you could take the part of the question that refers to what we’re expecting going forward. Phil?

Phil Johnson, Chief Financial Officer, Jazz Pharmaceuticals: Sorry. I have a bad connection here. So I was trying to get on to a handheld and not use the speaker. Can’t give me a second. So Jason, as Bruce mentioned, we’ve delevered substantially from the time of the GW deal.

I think we closed effectively at about 4.9 times net leverage at that point in time. As of the end of twenty twenty four, that was down to 1.8x. So we certainly have significant financial resources bolstered by the strong cash flow that we generate as well to engage in M and A and licensing activities for the various sizes. We do have active efforts looking at each of our verticals to continue to build our growth prospects in those that would include epilepsies where the very long runway with Epidiolex has been and continues to be a strong point I think for the overall Jazz story as well as making it play an even more attractive area for us to be investing in. So certainly, we do look at opportunities to build out that franchise further.

As Bruce mentioned in his prepared remarks, we do look at areas that would be either adjacencies to and in some cases newer areas that share characteristics with where we’ve been successful in the past. Often these are more orphan indications, more focused call points, the ability to add significant value with services in addition to just product and leverage those capabilities that we’ve built and honed over the years. So continue to be very active looking. I certainly would not take the lack of announcing a large deal as lack of activity or interest in doing things. And certainly, we’ve commented in the past, see no expectation of those activities slowing down as we move into the coming quarters.

So stay tuned. We’re active and looking. I do feel there’s opportunities that are of value to Jazz and if patients don’t see valuation, but this point in time being a significant impediment to transacting in the areas where we’re looking. So, if that gives us some color.

Conference Operator: Your next question comes from the line of Annabel Samimy with Stifel. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals1: Hi. Thanks for taking my question. Just quickly on Zubsalka, just curious if there was any strange trend, the end of the year we saw compressing a little bit. And then what can we expect from Zepsilka this year? I know you’re filing the sNDA.

The approval is not expected until 2026, but could we be seeing some entity and guideline with compendia listing for this specific indication? Thanks.

Renee Galla, President and Chief Operating Officer, Jazz Pharmaceuticals: Yes. Thanks for the question. This is Renee. So in terms of what we’ve seen with the Celco, we have continued to see strong performance. I would say typically from Q3 to Q4, we do have a dynamic where there are less buying days for our distributor in Q4 compared to Q3.

We had a similar dynamic in 2023. So that did have some impact. I will note though that, as we mentioned on the call, our sales increased 11% to $320,000,000 in 2024. That was the highest year ever for Zepsilka and that is with a competitive entrant in the market with Indelterra. As we look at 2025, we mentioned we plan to file in the first half of this year for our first line extensive stage with our first line extensive stage data.

We will not be promoting of course in the first line until we have that approval. We would hope to get on treatment guidelines as soon as we have the data out and available and in a peer reviewed journal which we’re working diligently on. And then I would also say that the benefit of course in the first line is to be able to reach patients earlier in their overall treatment journey. We do believe there’s a larger group of patients to access twenty seven thousand in first line versus seventeen thousand in the second line and about seventy percent of those first line patients are extensive stage. There’s also longer duration of treatment in the first line.

So, we do expect to see growth in Dapsilka. But again, we won’t be promoting in the first line until we have an actual approval. And then if I just step back and think about Zepsilka’s positioning in the second line, while we would expect to see, in Delta as a new competitive entrant to see some gain in the second line. I’d also say we continue to receive a lot of positive feedback from physicians on Zepsilka in terms of its clinical benefit, the ease of use, it does not require extended monitoring or an inpatient stay, which is of course different from INDLTRA. So, we do expect to continue to see some strength in Zepsilka and we look forward to having the ability to promote in the first line.

Conference Operator: Your next question comes from the line of Andrea Newkirk with Goldman Sachs. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals2: Good afternoon. Thanks for taking our questions. Bruce, I was just wondering if you might be willing to provide an update on the CEO search and the background or fit that the Board is looking for. And then in the context of that this ongoing transition, as a follow-up to the M and A or BD question earlier, how should we think about that strategy and the timing for a potential transaction to occur this year?

Speaker 7: Yes. Thanks for the question.

Speaker 9: So I’m not going to give

Speaker 7: a detailed update on the CEO selection process other than to say, as was true when this was announced back in December, we’re going to take our time and get it right. We’re not in a hurry. We want to make the right choice, and the right choice is dictated by where the company is today and where we want to take it. I will say we’re just starting to reach out in the marketplace, and we’re getting positive feedback that the position is an attractive one in terms of where the company is positioned today. We’re obviously coming off a very strong 2024 and are excited about our prospects for 2025.

On the M and A BD side, we’re really well positioned right now. We’ve got strong operating results. Our commercial teams, our R and D teams are executing well across the board. So from an operational perspective, we feel ready to take on. Additional programs and or products and as Phil mentioned from a financial perspective, whether it’s our balance sheet our cash on hand our cash flow, again, we feel very well positioned to really take advantage of our infrastructure, leverage it and continue to add growth opportunities to our business.

Conference Operator: Your next question comes from the line of Troy Langford with TD Cowen. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals0: Hi. Congrats on all the progress

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals3: this quarter and thanks for taking

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals0: our question. Just a really quick one on the opportunity for Xyhara and breast cancer. About how many breast cancer patients total do you think would fall into that HER2 progression or intolerance bucket that ZYHARA could potentially address should it succeed in the Phase three trial?

Speaker 7: So, Renee, I don’t know if you want to make an overarching comment about the opportunity we see for, for zanidetimab, including in breast cancer. And then, Rob, maybe you could talk a little bit more about how we see this fitting into the breast cancer treatment landscape.

Renee Galla, President and Chief Operating Officer, Jazz Pharmaceuticals: Sure. Thanks, Bruce. So, as we step back and look at the broader market opportunity, we do see this as a 2 plus billion dollar opportunity overall when we look at the indications we’re focused on right now. That includes BTC, GEA, breast cancer, as well as pan tumor. Now, BTC, we’ve said consistently that we expect the revenues to be, quite modest there given the very small patient population.

But as we get into larger indications such as GEA, we look at sixty three thousand patients across The U. S, Europe and Japan as compared to twelve thousand for BTC. And then as we progress into breast cancer, we’re looking at more than one hundred and fifty thousand patients across those same geographies. So, while we haven’t broken that up into the different elements, we do feel quite confident that there is a much broader opportunity to go after there. Rob?

Rob Noane, Executive Vice President, Global Head of R&D, Jazz Pharmaceuticals: Yeah. I would just add that, HER2 positive breast cancer patients in the metastatic setting tend to get multiple lines of therapy. Currently that’s the CLEOPATCHA regimen followed by HER2. There is

Conference Operator: an

Rob Noane, Executive Vice President, Global Head of R&D, Jazz Pharmaceuticals: ongoing frontline HER2 trial and there’s optimism that that will ultimately become the standard of care in frontline. So whether it be third line plus or second line plus, we think with positive results from the trial that we have ongoing, that Zaihara would become the treatment of choice after patients have progressed on HER2. And we think that captures a high proportion of patients given that these patients tend to be able to go on to subsequent lines of therapy.

Conference Operator: Your next question comes from the line of Akash Tewari with Jefferies. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals2: Hi, this is Amy on for Akash. Thanks so much for taking your question. How should we think about the pricing strategy for XANNY depending on whether the doublet or triplet arm hits in Horizon GA? If pricing remains consistent, how would the outcome of these arms impact your peak sales estimates?

Speaker 7: Renee?

Renee Galla, President and Chief Operating Officer, Jazz Pharmaceuticals: Yeah, I’m happy to jump in there. So, we have priced, Zihara for BTC with a twenty eight day cycle WACC cost of approximately $35,550 Now, when we priced it for BTC, there was also a view of thinking about GEA coming shortly thereafter. We haven’t given specificity around GEA. I’ll say the cycle there is twenty one days versus the twenty eight day cycle for VTC. And then, the weight based dosing is slightly different for VTC.

We’re looking at more of a average median weight of a patient when we give the twenty eight day cycle price. But with respect to GEA, what we’re looking at is a threshold above and below a certain weight, you would be going with a certain dosing. We’re not looking specifically at the doublet and triplet arm, and giving specific guidance with respect to the pricing or the peak. What we’re really focused on is ensuring that we’re able to capture a meaningful opportunity with GEA. And then as Rob

Conference Operator: had mentioned also a much larger opportunity with breast cancer. Your next question comes from the line of Mohit Bansal with Wells Fargo (NYSE:WFC). Please go ahead.

Speaker 9: Great. Thank you very much for taking my question and congrats on the progress. Rob, if you could help me understand the arm C of GE trial in little bit detail. It seems like in the context of commercial aspect, it is a pretty important arm given that majority of the patients are pretty even high patients. But again, this arm is not powered to show benefit over arm B.

So it seems like you are looking at just Zandi’s benefit over Herceptin, that may be enough. So in that context, could you help us understand like how would you look at ARM C and how should investors like us look at RMC when the data come out, in the context of market opportunity here? Thank you.

Rob Noane, Executive Vice President, Global Head of R&D, Jazz Pharmaceuticals: Yes. So for starters, I would say that the proportion of patients for whom the standard of care remains for septum chemo, we think is quite high. The KEYNOTE-eight 11 trial, we don’t think represents the true epidemiology. It’s likely that that trial was enriched for PD L1 positive, quote, PD L1 positive patients given the ubiquitous PD L1 testing during when that trial was conducted. We also think there’s a question around how to define PD L1 positive.

Are all patients with one TPS score of one or higher truly benefiting or would that optimal cutoff be higher? And if it’s higher, it really does drive that proportion of patients who truly benefit from a PD-one down quite a bit. Having said that, we think DIHARA has the opportunity to be the HER2 agent of choice regardless of PD L1 status. Arm B will demonstrate that in, Xyara combined with chemotherapy. And Arm C has the opportunity to demonstrate that in combination additionally with tislelizumab.

We haven’t spoken to the specific power of a comparison to arm C versus B, and we don’t necessarily think of that as being required. I mean, certainly for the arm C regimen of both Zihara and tislelizumab in combo with chemo to be approved, it has to be better than arm A. A. And it also has to be, from a broad benefit risk perspective, better than giving Xyhara alone with chemotherapy. And so we’ll have an opportunity to look at all those data as part of this trial.

And again, we think Xyhara will be, regardless of PD L1 status of the HER2 of choice.

Conference Operator: Your next question comes from the line of David Amsellem with Piper Sandler. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals4: Thanks. So, how are you thinking about Zepsilica’s exclusivity runway, particularly with the label expansion opportunity in first line. So that’s number one. And then secondly, to the extent that your own OREXAN program doesn’t pan out, I guess my question here is how badly do you need to be in the OREXAN game, so to speak? In other words, would you continue to pursue other OREXAN?

Or do you feel like there’s other areas in terms of M and A and biz dev, that you would then turn your focus on? Just trying to get a better sense of how you’re thinking about your sleep franchise to the extent there isn’t anorexin that moves forward in your pipeline? Thanks.

Speaker 7: Renee, you want to start on the Zepsylka question?

Renee Galla, President and Chief Operating Officer, Jazz Pharmaceuticals: Sure. Happy to do that. So, with respect to exclusivity, we have a composition of matter patent that extends to December 2029. And then we have additional patent applications that could extend that IEP protection further. I don’t think we have any comments beyond that to offer today, but stay tuned.

Speaker 7: And then on your specific question on the orexin space, we continue to watch as we all do data emerging from different agents in terms of what we’re seeing as the benefits of orexin therapy, certainly an exciting new mechanism of action across these serious sleep disorders, particularly with the daytime benefit. A little less clear right now whether the benefits at night are positive or whether there are, in fact, potential, concerns with, what it would do to nighttime sleep. We certainly believe there’s a role for ongoing use of oxibate as a nighttime agent, that helps consolidate sleep and produce additional daytime benefits, as we’ve seen with other daytime agents, that are currently available or have been studied. You know, in terms of do we need to be in that space, we’re, of course, interested, in the sleep space where we are a leader. We’re also interested in other, potential areas across neuroscience, oncology, as we’ve talked about, a rare disease where we’ve got relevant capabilities.

So, I don’t want to narrow us down to only one area, but we’re looking broadly across each of these areas for opportunities that

Speaker 9: we think would be a good fit, meeting an unmet need,

Speaker 7: good fit with our capabilities on the commercial side, efficient call point, good durability and an opportunity to diversify and produce sustainable growth over the longer term.

Conference Operator: Your next question comes from the line of Amy Fadia with Needham. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals5: Good evening. Thanks for taking my question. Perhaps to switch gears to the OXOIBIT franchise, can you talk about some of the dynamics in the innocently market and how you’re seeing Lumerise impact either your business or the overall market? Are you seeing switches from Xyrem or Xiway to Lumerise or any switchbacks? And then also as the AGs have the ability to launch their own generics at the end of the year, how should we think about sort of shoring up the Xyron revenues and switching them to Xiwei or and maybe just sort of what type of payer dynamics you expect once additional generics come to market and how that might impact Xiwei?

Thank you.

Speaker 7: Yes. Ami, that was a multipart question for sure. But, Renee, maybe you could talk about just what we’re seeing in the oxibate space and in particular how we think Zywave has continued to be positioned.

Renee Galla, President and Chief Operating Officer, Jazz Pharmaceuticals: Yes, absolutely. Happy to step through that. So I’d say just looking at our full year results in the fourth quarter results

Conference Operator: that

Renee Galla, President and Chief Operating Officer, Jazz Pharmaceuticals: we had, we’re really pleased with what we’re seeing with Zywave. We had record revenues in the fourth quarter ’19 percent year over year with five twenty five patient adds that includes of course narcolepsy and IH. And when we look at where our adds are coming from in narcolepsy, that’s coming from both new to oxybate patients, as well as patients switching from high sodium oxybates and that’s across all the high sodium oxybates. In terms of how we think about AG. So, when we look at 2026, you heard Phil earlier say that our assumptions with respect to our 2025 guidance, include the fact that we will be receiving royalty revenues from AGs throughout 2025.

So, if we’re thinking about the market in that way, and of course, we don’t know if any authorized generics will decide to launch early. That would be if Hikma were to decide specifically to launch early, that would invite other generics into the market before early twenty twenty six. And in that case for full generics, they would need to have their own REMS because right now the authorized generics are distributed through our REMS. So, as we look at 2026, what that then looks like is a situation where our ability to continue to drive revenues with Zywave is dependent on the continued appreciation of the differentiation of low sodium and the importance of that to long term health. In 2026, if we see full generics on the market, those royalty revenues would cease to exist.

And then we would also expect further erosion of Xyrem, which we do not actively promote and have not actively promoted since we launched XiWave. We continue to educate on the benefits of reducing sodium, including generating important data in this area, with Sideways being the only low sodium oxybate and therefore the only one that doesn’t carry a warning related to high sodium oxybate, sorry, high sodium intake. We can see clearly that physicians and patients are choosing that long term health benefit as well as the flexible dosing that comes with Zywave. Maintaining strong payer coverage, of course is important throughout this. We have the vast majority of our patients that are commercial today and we had great coverage with more than ninety percent of commercial lives covered.

And so, we will continue to educate on the benefits of reducing sodium and continue to generate data. And we have already shared data that makes it clear that with both narcolepsy and idiopathic hypersomnia, there’s an increased prevalence of cardiovascular comorbidities including heart failure and stroke compared to the general population. Those findings came from both CV Bond and CV Rhythms studies. So, stepping back, we’ll be continuing to focus on strengthening the differentiation of Zywave with physicians, customers and payers. We do believe we’re well positioned for 2026.

Zywave is not AB rated relative to generics. And as we look at the market with narcolepsy and idiopathic hypersomnia, we see the most opportunity for growth with idiopathic hypersomnia. We’re continuing to build that market, but we’re still early, very low penetration currently and definitely additional room for growth.

Speaker 7: And I’ll just jump in to remind people that the percentage of our revenues coming from the high sodium business, the old Xyrem branded sales and AG royalties has continued to decline over time, now probably in the latest quarter, maybe dipping below 10% for the first time.

Conference Operator: Your next question comes from the line of Gary Nachman with Raymond (NSE:RYMD) James. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals6: Thanks. Good afternoon. On the 2025 guidance, you didn’t break down the revenue components specifically this time. So, can you give us more of a sense of how you expect the neuro and oncology franchises to trend relative to the overall revenue growth of 5% that you said this year? And then just the R and D, as you’re scaling back at expenses relative to last year, down 8%, just talk more about the reprioritizations of the pipeline and what’s the right level of spend going forward for R and D as a percentage of revenue?

Thank you.

Speaker 7: Phil, you want to jump in on that?

Phil Johnson, Chief Financial Officer, Jazz Pharmaceuticals: Yes. Gary, I’m happy to. So on revenue, what might be helpful as you think about the pushes and pulls for the year, sort of step through the various products. Let me start with the larger ones first and work my way down. So Zywave, as Renee had mentioned, really strong momentum growing 18% in the full year last year, 19% in the fourth quarter, Really strong net patient adds, five twenty five in the fourth quarter, so well positioned for continued growth there.

Similarly, at the DIALux, really strong momentum, again, 15% growth for the full year, 14% in the fourth quarter and we’re well positioned to reach blockbuster status in 2025. I’m very pleased with the longevity of that franchise moving forward. Rylase, about 4% growth for the full year relatively flat in the fourth quarter, reflecting that negative impact that we’ve mentioned in the second half of twenty twenty four coming from the COG protocol change where we continue to expect revenue to normalize early this year. Zepsilka, again, 11% growth for the full year. That did dip down to 6% in the fourth quarter in part for the number of days that we had for shipping, as Renee mentioned.

We feel really good about prospects for Zepsilka when we get the first line maintenance indication included in treatment guidelines and get it into the label when approved by FDA. And in the interim, we may see some weakness in Zepsilka sales as Indaltra gained share in that second line plus setting. Defitelio, really strong growth, particularly in the second half of the year in The U. S. As we mentioned in the past, we’re monitoring that situation to understand how much

Speaker 9: of that uptick we saw

Phil Johnson, Chief Financial Officer, Jazz Pharmaceuticals: in the second half is sustainable for providing a new base for the product and how much of that may be transitory. This really relates to use of inatumumab to prepare patients for their procedures that can lead to an increased incidence or DOD. So again, we’ll see in coming quarters if that’s durable. And then on the high sodium oxybate front, as Renee mentioned, if you think about the AG royalty revenue, that nearly tripled in 2024 compared to 2023. That was largely due to the significant increase in the royalty rate in late twenty twenty three as well as additional volume coming through that channel in 2024.

With that royalty rate increase now fully annualized, growth from that royalty revenue should moderate accordingly in 2025. And then finally, Xyrem, revenue was less than half in 2024, what it was in 2023 with revenue coming down 59%. So mathematically, the drag from lower Xyrem revenue has to moderate in 2025 and be a bit of a buoy, if you will, less of a drag on growth this year than it was last year. So that gives you some color across the portfolio. In terms of R and D spend, you mentioned at the very end of your question, Gary, the sort of percent of revenue.

We’re not necessarily thinking of it in that way. We do think we have some very good opportunities, particularly with dandidatumab that make a lot of sense to invest behind. And when we’ve got those great investment opportunities, we will fund those and that will cause the funding level as a percent of revenue to moderate up or down depending on how many of the opportunities that we have. And the mentioning of the call text and then prior answer to questions and some of the prioritization on R and D really reflects some of the readouts we had last year, three eighty five to a certain extent, 150 as well, where those are programs are no longer investing behind given those outcomes. We do expect to be active in corporate development activities that certainly would add to our portfolio and could bring in promising additional assets to invest behind so that can lead to additional uptick.

And then we’ll see as we go forward with the data readouts for any data map and we more fully talk about the full program of how to invest behind that asset to drive the most value for Jazz and impact the most patients sort of additional investments that will come there. But those will be some of the pushes and pulls that I’d cite.

Conference Operator: Your next question comes from the line of Gregory Renza with RBC Capital Markets. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals7: Hi, guys. It’s Anish on for Greg. Thanks for the updates this quarter and for taking our questions. As you look at Zaihara’s Phase three GA top line now guided for the second half, how should we be thinking about timelines for subsequent analyses, including the second and third interim overall survival analyses? And quickly on Epidiolex, what levers can be pulled or hang ups removed to enhance uptake across the treatment segments?

Thanks so much.

Speaker 7: Rob, why don’t you start on zanidetimab readout timing and then Renee, you can comment on Epidiolex. Yes.

Rob Noane, Executive Vice President, Global Head of R&D, Jazz Pharmaceuticals: So, the projected readout that we just provided is based on progression events. And at the time of that PFS analysis, we would have the first interim analysis for overall survival. So as you’ve seen as you see that timeline get pushed out, of course, that also allows for greater maturity and overall survival. So we’d expect more maturity of that first interim than we might have had, if the readout were sooner. Again, we’re not referring specifically to the pace of overall survival events.

So this, this new projection, has no implications for the second survival analysis or the final. There’s three in total.

Renee Galla, President and Chief Operating Officer, Jazz Pharmaceuticals: And then I’ll jump in on the Epidiolex question. So, I would say we’re really pleased with the growth that we’re seeing. We do have quite a bit of runway now that we’re really excited about in closing the GW transaction. We were quite confident in the durability and long lived nature of this asset and we’re pleased to be at a point now where we can have a greater clarity on what that looks like. So as we look at what’s driving the increased growth right now and what we’ll continue to lean into, Epidiolex is highly differentiated and that’s supported by the data that we’ve generated for both seizure and non seizure benefits.

And that data really resonates with physicians, as well as as well as with caregivers. We have great momentum in the adult and long term care setting. And that’s an area we’re making investments in the breadth and quality of our access continues to improve. And that’s having a positive impact as we see pull through. We excuse me, persistency has always been a hallmark of this brand and we’re seeing great impact even additional benefit to persistency through nurse navigator programs.

And we’re also piloting new programs within this area where we’re seeing some early success, highly targeted consumer ads and also things like we’ve added virtual account manager positions. So, this is an area where we continue to learn and we’re really thrilled with the results that we’re seeing.

Conference Operator: Your next question comes from the line of June Lee with Truett Securities. Please go ahead.

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals3: Congrats on the quarter and thanks for taking the questions. This is awesome on for June. Just a couple from us.

Conference Operator: I

Jeff McDonald, Executive Director, Investor Relations, Jazz Pharmaceuticals3: know you haven’t updated us completely on the four forty one program, but what are you thinking in terms of the amount of dose reduction? And, just going off David’s question earlier around how much longer could the pending patents for Zepsilka extend exclusivity beyond December 2029? Thank you.

Speaker 7: So I hate to do this to you on the last question, but I don’t think we’re going to provide additional information on either of those. Obviously, we’ve talked about the ability to go to a lower dose in patients than in healthy normals on four forty one. So that’s one of the things we’re exploring, even in a small number of patients. And then on Zepsilka, we don’t have specific additional information on what that could mean in terms of longer exclusivity for that agent at this point.

Conference Operator: That concludes our Q and A session. I will now turn the conference back over to Bruce Kozad, Chairman and Chief Executive Officer, for closing remarks.

Speaker 7: Yes. Thank you, operator. And, I apologize to the couple sell siders we didn’t get to. We were given our best shot to get through everything. And hopefully, we’ll talk to you later this evening.

I’d like to just close today’s call by recognizing our Jazz colleagues for their efforts and thank our partners and shareholders for their continued confidence and support. And thank you all for joining us today.

Conference Operator: This concludes today’s conference call. You may now disconnect.

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