Jazz Pharmaceuticals (JAZZ) FY Conference June 11, 2025 10:00 AM ET Speaker0 Good morning, everyone. Thanks so much for joining us. I'm Andrea Newkirk, one of the biotech analysts here at Goldman Sachs, and I'm really pleased to be joined by Phil Johnson, CFO and Rob Yunone, EVP of Global Head of R and D and CMO of Jazz. Thank you guys both for joining us this morning. Speaker1 Thanks for having us. Speaker0 Maybe we'll start at a high level here. There's so much macro uncertainty going on right now. Maybe ...

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.

June 10, 2025 Zepzelca® IMforte Data Webcast Innovating to Transform the Lives of Patients and Their Families Transforming Lives. Redefining Possibilities. 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 development, regulatory and commercialization strategy; the advancement of pipeline programs and the timing of development activities, regulatory activities and subm ...

Target Action (PDUFA) Date set for October 7, 2025Application based on data from IMforte, the first Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in both progression-free and overall survival in the ES-SCLC first-line maintenance settingJazz to host investor webcast on Tuesday, June 10 at 4:30 p.m. EDT / 9:30 p.m. IST to review Zepzelca dataFor U.S. media and investors onlyDUBLIN, June 10, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today annou ...

A month has gone by since the last earnings report for Jazz Pharmaceuticals (JAZZ) . Shares have added about 7.9% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Jazz due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts.How Have Estimates Been Moving Since Then?It turns ...

First-line maintenance combination therapy reduced the risk of disease progression or death by 46%, with a median overall survival of 13.2 months vs 10.6 months for atezolizumab alone from the point of randomizationFirst Phase 3 study to demonstrate statistically significant and clinically meaningful improvements in both progression-free and overall survival in ES-SCLC first-line maintenanceResults presented at the ASCO 2025 Annual Meeting and simultaneously published in The LancetJazz to host investor webc ...

Phase 2 trial results continue to show clinically meaningful efficacy and durable responses, including 36.5-month median overall survival after four years of follow-up, with a manageable safety profileFindings presented today at ASCO 2025 and concurrently published in The Lancet OncologyFor U.S. media and investors only DUBLIN, June 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced long-term data, including the first report of median overall survival (OS) from the Phase 2 trial ...

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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.

Have you evaluated the performance of Jazz Pharmaceuticals' (JAZZ) international operations for the quarter ending March 2025? Given the extensive global presence of this drugmaker, analyzing the patterns in international revenues is crucial for understanding its financial strength and potential for growth.In the modern, closely-knit global economic landscape, the capacity of a business to access foreign markets is often a key determinant of its financial well-being and growth path. Investors now place grea ...