Core Insights - Jazz Pharmaceuticals reported revenue of $1.05 billion for the quarter ended June 2025, reflecting a year-over-year increase of 2.1% but a slight miss of 0.26% against the Zacks Consensus Estimate [1] - The company experienced a significant decline in EPS, reporting -$8.25 compared to $5.30 in the same quarter last year, resulting in an EPS surprise of -34.8% against the consensus estimate of -$6.12 [1] Revenue Breakdown - Total revenues from royalties and contract revenues were $60.14 million, exceeding the average estimate of $55.53 million by analysts [4] - Product sales, net, amounted to $985.57 million, slightly below the average estimate of $999.45 million, with a year-over-year change of +2.2% [4] - Neuroscience total revenues reached $707.02 million, which was lower than the estimated $716.27 million, but represented a year-over-year increase of +3.3% [4] - Oncology total revenues were $274.15 million, marginally below the average estimate of $274.32 million, reflecting a year-over-year decrease of -1.1% [4] - Specific product performance included: - Rylaze/Enrylaze: $100.66 million, below the estimate of $105.31 million, a -6.7% change year-over-year [4] - Oxybate (Xywav & Xyrem): $450.67 million, exceeding the estimate of $440.11 million, with a +4.7% change year-over-year [4] - Sativex: $4.62 million, below the estimate of $5.63 million, a -27.7% change year-over-year [4] - Oxybate - Xyrem: $35.35 million, slightly above the estimate of $34.64 million, a -43.2% change year-over-year [4] - Defitelio/defibrotide: $48.11 million, above the estimate of $47.83 million, a +5.9% change year-over-year [4] - Vyxeos: $44.85 million, exceeding the estimate of $41.48 million, a +4.3% change year-over-year [4] - Zepzelca: $74.54 million, below the estimate of $77.82 million, an -8% change year-over-year [4] - Oxybate - Xywav: $415.32 million, above the estimate of $405.49 million, a +12.7% change year-over-year [4] Stock Performance - Jazz Pharmaceuticals' shares have returned +7.9% over the past month, outperforming the Zacks S&P 500 composite, which changed by +1% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]

Financial Data and Key Metrics Changes - Jazz Pharmaceuticals reported total revenues of $1,050,000,000 for Q2 2025, representing a 2% increase year-over-year, driven by robust growth in Xywav, which grew 13% [31][32] - The adjusted net loss for Q2 2025 was $5,000,000, primarily due to a non-tax-deductible charge from the Chimerix acquisition [33] - Operating cash flow for the first half of the year was $519,000,000, with a strong balance sheet showing $1,700,000,000 in cash and investments at quarter-end [33][34] Business Line Data and Key Metrics Changes - In the neuroscience segment, Xywav generated approximately $415,000,000 in net product sales, with a 13% year-over-year increase [15][31] - Epidiolex saw net product sales of approximately $252,000,000, reflecting a 2% increase year-over-year, impacted by U.S. inventory dynamics [17][32] - Oncology products experienced a 1% decrease in total sales, primarily due to lower sales of Rylase and Zepzelca, offset by higher sales of ZYHERA, Defitelio, and Vyxeos [32] Market Data and Key Metrics Changes - The company noted strong underlying demand for Epidiolex, with expectations to reach blockbuster status this year despite inventory dynamics affecting growth rates [77][81] - Xywav remains the only low sodium oxybate therapy and the number one branded treatment for narcolepsy, with significant patient additions in both narcolepsy and idiopathic hypersomnia [10][15] - Zepzelca's net product sales were approximately $75,000,000, an 8% decrease year-over-year, attributed to increased competition and changes in treatment protocols [21][32] Company Strategy and Development Direction - The company is focused on executing its commercial strategy and advancing key development programs, with upcoming PDUFA dates for dorvaprone and Zepzelca [39][40] - Jazz Pharmaceuticals aims to leverage its diversified portfolio and robust pipeline for sustainable long-term growth, emphasizing the importance of capital allocation and corporate development [11][34] - The recent acquisition of Chimerix is expected to enhance Jazz's presence in rare oncology, particularly with the anticipated approval of dorvaprone [8][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the diversified portfolio and the potential for future growth, particularly with the upcoming FDA approvals [8][39] - The company acknowledged near-term headwinds in the oncology portfolio but remains optimistic about returning to growth driven by new opportunities [39] - Management emphasized the importance of execution and delivering innovative therapies for patients, with a focus on patient impact and corporate responsibility [11][39] Other Important Information - The company revised its financial guidance for 2025, narrowing the revenue range while adjusting SG&A and R&D guidance to enhance operational efficiency [34][35] - Jazz Pharmaceuticals is preparing for the commercial launch of dorvaprone and Zepzelca, with significant investments in marketing and education to support these products [34][36] Q&A Session Summary Question: What is driving the strength of Xywav and idiopathic hypersomnia? - Management highlighted strong execution across field teams, effective digital campaigns, and the role of field nurse educators in supporting patient persistence and education [42][46][47] Question: What can be expected from the ZANI Phase III trial? - Management indicated that top-line updates would focus on primary and significant secondary endpoints while preserving the ability to publish detailed results later [51][52] Question: What are the competitive headwinds for Zepzelca? - Management acknowledged increased competition and changes in treatment protocols affecting Zepzelca's sales but expressed optimism about upcoming approvals that could enhance its market position [57][61] Question: What underlies confidence in Epidiolex reaching blockbuster status? - Management cited strong underlying demand and anticipated inventory dynamics that would support growth, despite some fluctuations in quarterly comparisons [76][81] Question: How will the entry of multi-source generics impact the oxybate franchise? - Management emphasized the differentiation of Xywav as the only low sodium oxybate and its established position in the market, which should mitigate potential impacts from generics [78][79]

Financial Data and Key Metrics Changes - Jazz Pharmaceuticals reported total revenues of $1,050,000,000 for the second quarter of 2025, representing a 2% increase year over year, driven by robust growth in Xywav, which grew 13% [30][31] - The adjusted net loss for the second quarter was $5,000,000, primarily due to a non-tax deductible acquired IPR&D charge from the Chimerix acquisition [32] - Operating cash flow for the first half of the year was $519,000,000, with a strong balance sheet showing $1,700,000,000 in cash and investments at quarter end [32][33] Business Line Data and Key Metrics Changes - Xywav generated approximately $415,000,000 in net product sales, with a 13% year-over-year increase, and added approximately 6,250 net patients across narcolepsy and idiopathic hypersomnia [15][10] - Epidiolex saw net product sales of approximately $252,000,000, a 2% increase year over year, impacted by U.S. inventory dynamics [17][31] - Rylase net product sales were approximately $101,000,000, a decrease of 7% year over year, while Zepzelca sales were approximately $75,000,000, down 8% year over year [19][21] Market Data and Key Metrics Changes - The oncology portfolio faced near-term headwinds, but there are expectations for growth driven by upcoming catalysts, including the PDUFA for dorvaprone and Zepzelca [11][21] - ZYHERA recognized approximately $6,000,000 in net product sales, aligning with expectations at this early stage of launch [22] Company Strategy and Development Direction - The company is focused on executing its strategy to deliver innovative therapies, with a diversified portfolio and robust pipeline positioned for sustainable long-term growth [11][12] - Upcoming FDA approvals for dorvaprone and Zepzelca are seen as significant milestones, with the potential to redefine treatment paradigms in their respective areas [11][21] - The company plans to enhance operational efficiency and prioritize spending on high-impact initiatives, including the launch of dorvaprone and support for Zepzelca and ZYHERA [33][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the diversified portfolio and the potential for future growth, particularly with the anticipated approval of dorvaprone [7][11] - The management acknowledged the competitive landscape, particularly for Zepzelca, but remains optimistic about the upcoming PDUFA dates and the potential for practice-changing data [21][59] Other Important Information - The company has revised its 2025 revenue guidance, narrowing the range and reflecting a modest reduction in the midpoint, while raising the lower end of adjusted net income and EPS guidance [33][34] - The company is committed to maintaining a disciplined approach to capital allocation, ensuring strategic investments in R&D and commercial products [36] Q&A Session Summary Question: What is driving the strength of Xywav and IH? - Management highlighted strong execution across field teams, effective digital campaigns, and the unique position of Xywav as the only FDA-approved therapy for IH as key drivers of growth [41][46] Question: Can we expect qualitative or quantitative updates for the ZANI trial? - Management indicated that they typically provide qualitative updates while preserving the ability to publish detailed results later, focusing on primary and secondary endpoints [50][52] Question: What are the competitive headwinds for Zepzelca? - Management acknowledged increased competition and the impact of immunotherapy on patient progression but expressed optimism about the upcoming PDUFA for first-line maintenance therapy [55][59] Question: What underlies confidence in Epidiolex reaching blockbuster status? - Management cited strong underlying demand and anticipated inventory dynamics as factors supporting confidence in reaching blockbuster status this year [74][76] Question: How will the entry of multi-source generics impact the oxybate franchise? - Management emphasized the differentiation of Xywav as the only low sodium oxybate and its established position in the market, suggesting limited impact from potential generic entries [78]

August 5, 2025 2025 Second Quarter Financial Results Innovating to Transform the Lives of Patients and Their Families EPIDIOLEX® patient diagnosed with Dravet syndrome Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements and financial targets, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the Company's 2025 financial guidance and the Company's expectations related there ...

Summary of Zepzelca ASCO Data Webcast Company and Industry Overview - **Company**: Jazz Pharmaceuticals - **Industry**: Oncology, specifically focusing on small cell lung cancer (SCLC) Key Points and Arguments 1. **Clinical Data Presentation**: Jazz Pharmaceuticals presented compelling clinical data for Zepzelca at the ASCO Annual Meeting, focusing on its use in small cell lung cancer [2][5][6] 2. **Zepzelca's Current Indication**: Zepzelca is currently indicated for the treatment of small cell lung cancer and is expected to bring a new treatment regimen that shows clinically meaningful improvement over the current standard of care [6][30] 3. **Market Opportunity**: The oncology business is primarily driven by Zepzelca and Rylase, with a total revenue exceeding $1 billion in the previous year, indicating significant growth potential [7][8] 4. **INFORTE Trial Results**: The Phase III INFORTE trial demonstrated that the combination of lurbinectedin and atezolizumab significantly improved progression-free survival (PFS) from 2.1 months to 5.4 months, and overall survival (OS) from 10.6 months to 13.2 months [12][25][31] 5. **Safety Profile**: The combination therapy was generally well tolerated, with a low discontinuation rate due to adverse events (6.2% for the combination vs. 3.3% for atezolizumab alone) [23][31] 6. **Commercialization Strategy**: Jazz plans to incorporate Zepzelca into the first-line maintenance therapy for extensive stage SCLC, which is expected to increase patient eligibility and treatment duration [36][40] 7. **NCCN Guidelines Submission**: Jazz has submitted data to the National Comprehensive Cancer Network (NCCN) for consideration, which is crucial for broader uptake and reimbursement [34] 8. **FDA Submission**: A supplemental New Drug Application (sNDA) for Zepzelca's expanded indication has been accepted by the FDA, with a priority review assigned and a PDUFA date of October 7, 2025 [35] Additional Important Content 1. **Patient Population**: Approximately 30,000 patients are diagnosed with small cell lung cancer annually in the U.S., with about 70% having extensive stage disease [36][37] 2. **Treatment Landscape**: The current standard of care involves platinum-based chemotherapy and immunotherapy, but there is a high attrition rate, with up to 60% of patients not receiving second-line therapy [13][22] 3. **Future Development**: Jazz is exploring additional development opportunities for Zepzelca beyond SCLC, including combinations with other therapies [92][95] 4. **Competitive Dynamics**: The company acknowledges potential competition from other products but believes that Zepzelca's data will lead to rapid adoption in the frontline maintenance setting [48][76] 5. **Long-term Tracking**: There are plans to track long-term outcomes for patients receiving maintenance therapy with Zepzelca [60] This summary encapsulates the critical insights from the Zepzelca ASCO Data Webcast, highlighting the company's strategic direction, clinical advancements, and market potential in the oncology sector.

IMforte Trial Results and Implications - The IMforte trial demonstrated a statistically significant improvement in Progression-Free Survival (PFS) and Overall Survival (OS) with first-line (1L) maintenance treatment using lurbinectedin + atezolizumab versus atezolizumab alone in patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)[29, 77] - The median PFS was 54 months with lurbinectedin + atezolizumab compared to 21 months with atezolizumab alone, with a stratified Hazard Ratio (HR) of 054 (95% CI 043, 067) and a p-value of less than 00001[49] - The median OS was 132 months with lurbinectedin + atezolizumab compared to 106 months with atezolizumab alone, with a stratified HR of 073 (95% CI 057, 095) and a p-value of 00174[55] - The combination therapy showed a manageable safety profile, with most Adverse Events (AEs) being low grade and treatment discontinuation rates remaining low[29, 77] Zepzelca Commercial Opportunity - The company views the IMforte data as practice-changing, potentially establishing Zepzelca as a foundational treatment in ES-SCLC[94] - The company plans to drive further adoption of the 1L maintenance regimen with Zepzelca + atezolizumab[92] - The company intends to continue the use of Zepzelca in second-line (2L+) Zepzelca-naïve patients[93] Regulatory and Development - The supplemental New Drug Application (sNDA) for Zepzelca has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target date of October 7, 2025[86] Zanidatamab Potential - The company anticipates zanidatamab to have a peak potential exceeding $2 billion across multiple HER2+ tumors[2, 20]

Summary of Jazz Pharmaceuticals (JAZZ) 2025 Conference Call Company Overview - **Company**: Jazz Pharmaceuticals (JAZZ) - **Event**: BofA Annual Healthcare Conference - **Date**: May 14, 2025 Key Points Financial Performance - **1Q Revenue**: Approximately $898 million, consistent with 1Q 2024 [3] - **Growth Drivers**: Strong performance in neuroscience products, particularly XiWave and Epidiolex [4] - **Oncology Performance**: Oncology revenue declined by 11% year-on-year, attributed to a calendar anomaly with only 12 shipping weeks in the quarter [5][6] Product Performance - **XiWave**: Experienced seasonality affecting patient insurance reauthorization, resulting in a net addition of 450 patients, with 325 in idiopathic hypersomnia and 125 in narcolepsy [4] - **Epidiolex**: Achieved double-digit growth, impacted by higher-than-usual inventory drawdown in 1Q [5] - **Oncology Products**: - Rylase faced competitive dynamics affecting sales [7] - Zepzelca's performance was impacted by competition and longer patient progression times due to new data from Imfinzi [7] - Upcoming ASCO presentation for Phase III IMFORT trial data for Zepzelca [7][8] Acquisitions and Pipeline - **Chimerix Acquisition**: Completed in April, bringing dordavaprone for H3K27M mutant diffuse glioma, a severe brain cancer with poor prognosis [11][12] - **Zanidatumab**: Positive CHMP recommendation for approval in Europe for second-line BTC, with data to be presented at ASCO [12][13] - **Phase II GEA Study**: Updated data to be presented at ASCO, with confidence in upcoming Phase III study results [13][14] Regulatory and Market Dynamics - **Tariffs**: Company positioned to mitigate potential impacts from tariffs on imported pharmaceuticals, with no expected impact on 2025 financials [14][15] - **FDA Interactions**: No disruptions noted in FDA review processes for upcoming PDUFA dates for Subselka and dordavaprone [21] Competitive Landscape - **Generics Impact**: Anticipation of true generics for Xyrem starting in 2026, with potential revenue impacts for Jazz [22][24] - **Xywav Positioning**: Positioned as the only low sodium oxybate, with expectations of maintaining market share despite generics [26][27] Future Outlook - **Revenue Guidance**: Confirmed top-line revenue guidance with modest adjustments, expecting mid-single-digit growth for the full year [17][18] - **Pipeline Investments**: Strong financial position allows for continued investment in marketed products and pipeline development [16] Additional Insights - **Orexin Therapies**: Seen as complementary to oxybate therapy rather than competitive, with current data not supporting claims of improved nighttime sleep quality [59][60] - **Chimerix Trial Adjustments**: Ongoing evaluation of the ACTION trial protocol to enhance chances of success [62][63] Conclusion - Jazz Pharmaceuticals is navigating a complex landscape with strong performance in neuroscience, challenges in oncology, and strategic acquisitions. The company is well-positioned to manage upcoming competitive pressures and regulatory challenges while maintaining a focus on growth and innovation in its product pipeline.

Core Viewpoint - Jazz Pharmaceuticals reported disappointing first-quarter 2025 earnings, significantly missing consensus estimates due to increased operating expenses and a decline in revenues, leading to a drop in share price [1][2][4]. Financial Performance - Adjusted earnings for Q1 2025 were $1.68 per share, missing the Zacks Consensus Estimate of $4.51, representing a 36% year-over-year decline [1]. - Total revenues decreased by 0.5% year over year to $897.8 million, also falling short of the Zacks Consensus Estimate of $981 million [2]. - Net product sales remained flat at $839.4 million, missing both the Zacks Consensus Estimate and internal estimates [4]. Segment Performance - Neuroscience segment sales increased by 4% to $605.2 million, with combined oxybate sales (Xyrem + Xywav) rising about 1% to $382 million, but still missing estimates [6][7]. - Sales of Xyrem plummeted 42% year over year to $37.2 million due to patient transitions to Xywav and the introduction of authorized generics [6]. - Xywav sales reached $344.8 million, up 9% year over year, driven by strong uptake in narcolepsy and idiopathic hypersomnia indications [7]. - Oncology segment sales fell by 11% to $229.4 million, with specific drugs like Rylaze and Zepzelca experiencing significant declines due to competitive pressures and protocol updates [9][10][11]. Operating Costs - Adjusted selling, general and administrative expenses surged by 52% year over year to $472.3 million, primarily due to antitrust litigation settlements [13]. - Adjusted research and development expenses decreased by 22% to $220.9 million, attributed to lower clinical program costs [13]. Guidance and Outlook - Jazz Pharmaceuticals maintained its total sales guidance for 2025, projecting revenues between $4.15 billion and $4.40 billion, indicating a 5% year-over-year growth at the midpoint [15]. - Adjusted SG&A expenses are now expected to be between $1.47 billion and $1.53 billion, while adjusted R&D expenses are forecasted to be between $760 million and $810 million [16]. - The company revised its adjusted earnings guidance down to a range of $4.00 to $5.60 per share, significantly lower than previous estimates [16].

Core Insights - Jazz Pharmaceuticals reported revenue of $897.84 million for Q1 2025, a year-over-year decline of 0.5% and an EPS of $1.68, down from $2.68 a year ago, indicating significant underperformance against analyst expectations [1] - The revenue fell short of the Zacks Consensus Estimate of $981.41 million by 8.52%, while the EPS was 62.75% below the consensus estimate of $4.51 [1] Revenue Breakdown - Royalties and contract revenues were $58.42 million, slightly above the estimated $56.30 million [4] - Product sales, net, were $839.42 million, compared to the average estimate of $925.39 million, reflecting a year-over-year change of -0.3% [4] - Total revenues from Neuroscience for Oxybate (Xywav) were $344.80 million, below the estimate of $377.35 million, with a year-over-year increase of 9.4% [4] - Revenues from Epidiolex/Epidyolex totaled $217.74 million, compared to the estimate of $233.21 million, marking a 9.6% increase year-over-year [4] - Sativex revenues were $5.41 million, exceeding the estimate of $3.79 million, with a significant year-over-year increase of 97.7% [4] - Total Neuroscience revenues were $605.19 million, below the estimate of $652.54 million, with a year-over-year increase of 4.2% [4] - Total Oncology revenues were $229.45 million, below the estimate of $269.04 million, reflecting a year-over-year decline of 10.9% [4] - Rylaze revenues were $94.23 million, below the estimate of $104.20 million, with an 8.3% decline year-over-year [4] - Revenues from Defitelio/defibrotide were $40.66 million, below the estimate of $47.89 million, representing a 14.7% year-over-year decline [4] - Vyxeos revenues were $29.54 million, below the estimate of $34.56 million, with a year-over-year decline of 7.7% [4] - Zepzelca revenues were $63.03 million, below the estimate of $80.75 million, reflecting a year-over-year decline of 16.1% [4] Stock Performance - Jazz Pharmaceuticals' shares returned +10.5% over the past month, compared to the Zacks S&P 500 composite's +11.5% change, indicating a performance in line with the broader market [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the market in the near term [3]

Financial Data and Key Metrics Changes - Jazz Pharmaceuticals reported total revenues of $898 million for Q1 2025, reflecting a solid commercial performance despite some headwinds in oncology products [6][26][27] - Revenues from the neuroscience portfolio, particularly Xywav and Epidiolex, grew by 9% and 10% year over year, respectively [6][12][14] - Oncology product sales decreased by 8% year over year, primarily due to changes in pediatric treatment protocols and one fewer shipping week compared to the previous year [15][27] Business Line Data and Key Metrics Changes - The sleep therapeutic area generated approximately $431 million in total revenue, with Xywav net product sales at approximately $345 million, marking a 9% increase year over year [10] - Epidiolex had net product sales of approximately $218 million, a 10% increase year over year, driven by underlying demand and favorable U.S. payer mix [12][14] - Oncology net product sales were approximately $94 million, down 8% year over year, with expectations for normalization in the coming quarters [15][27] Market Data and Key Metrics Changes - Xywav remains the number one branded treatment for narcolepsy, with approximately 14,600 active patients, reflecting a robust quarter of patient additions [10] - The idiopathic hypersomnia market is showing significant growth, with a 39% increase in patient adds over the last twelve months [84] - The company anticipates three potential regulatory approvals in oncology in the coming months, which could drive future growth [7][8] Company Strategy and Development Direction - The acquisition of Chimerix is expected to enhance Jazz's presence in rare oncology and provide a near-term commercial opportunity with doravaprone [6][24] - The company is focused on advancing its R&D pipeline, with key trials and data presentations expected at ASCO in June [8][19] - Jazz Pharmaceuticals aims to maintain financial flexibility and operational excellence while navigating potential tariff impacts [9][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the top-line revenue guidance for 2025, affirming a range of $4.15 billion to $4.4 billion, representing 5% year-over-year growth at the midpoint [33] - The company remains optimistic about the growth potential of Epidiolex and Xywav, with expectations for Epidiolex to reach blockbuster status in 2025 [14][34] - Management highlighted the importance of corporate development as a key strategy for long-term shareholder value [62] Other Important Information - The company updated its financial guidance to reflect the Chimerix acquisition and litigation settlement charges, impacting adjusted net income and earnings per share [28][33] - Jazz Pharmaceuticals has sufficient inventory in the U.S. to meet its 2025 needs, mitigating potential tariff impacts [30][29] Q&A Session Summary Question: Can you discuss the supply chain for Xywav and its U.S. manufacturing capabilities? - Management confirmed that they have a U.S. supplier for oxybate, including Xywav, with sufficient capacity to meet U.S. needs [42] Question: What is Jazz's manufacturing footprint and potential mitigation strategies for tariffs? - The company has manufacturing facilities in the U.S. and Europe, providing flexibility in sourcing and production [46] Question: How does the Chimerix acquisition fit into Jazz's strategy? - The acquisition aligns with Jazz's focus on addressing unmet medical needs in oncology and provides a near-term commercial opportunity [62] Question: What are the expectations for Zepzelca's growth trajectory amid competition? - Management anticipates that the first-line contribution will outweigh pressure from competitors, with upcoming data expected to be practice-changing [51][54] Question: What is the status of the doravaprone trial and its potential impact? - The FDA review is proceeding as expected, with no surprises, and the company is evaluating potential changes to the trial analysis plan [80]