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Jazz Pharmaceuticals Names Renee Gala as President and Chief Executive Officer
Prnewswire· 2025-07-10 11:30
– Selection Follows Robust Succession Process Led by the Board –– Bruce Cozadd to Retire as CEO and Remain Chairperson of the Board of Directors –DUBLIN, July 10, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Jazz Board of Directors has unanimously selected Renee Gala, Jazz's President and Chief Operating Officer, as the President and Chief Executive Officer, effective August 11, 2025, when she will also join the Board. She will succeed co-founder, Chairperson and CEO ...
Jazz Pharmaceuticals (JAZZ) FY Conference Transcript
2025-06-11 15:00
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 ...
Jazz Pharmaceuticals (JAZZ) 2025 Conference Transcript
2025-05-14 18:00
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.
JAZZ Misses Q1 Earnings & Sales Estimates, Cuts '25 EPS Outlook
ZACKS· 2025-05-07 16:55
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].
Here's What Key Metrics Tell Us About Jazz (JAZZ) Q1 Earnings
ZACKS· 2025-05-06 23:30
Jazz Pharmaceuticals (JAZZ) reported $897.84 million in revenue for the quarter ended March 2025, representing a year-over-year decline of 0.5%. EPS of $1.68 for the same period compares to $2.68 a year ago.The reported revenue represents a surprise of -8.52% over the Zacks Consensus Estimate of $981.41 million. With the consensus EPS estimate being $4.51, the EPS surprise was -62.75%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to ...
Jazz Pharmaceuticals(JAZZ) - 2025 Q1 - Earnings Call Transcript
2025-05-06 20:30
Jazz Pharmaceuticals (JAZZ) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Speaker0 Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals First Quarter twenty twenty five Webcast Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, Speaker1 there Speaker0 will be a question and answer session. Thank you. I would now like to ...
Jazz Pharmaceuticals(JAZZ) - 2025 Q1 - Earnings Call Transcript
2025-05-06 20:30
Financial Data and Key Metrics Changes - The company reported total revenues of $898 million for Q1 2025, with a year-over-year growth of 9% for Xywav and 10% for Epidiolex [8][29][30] - Adjusted net income was impacted by a $172 million charge related to Xyrem antitrust litigation settlements, reducing GAAP and non-GAAP EPS by $2.38 and $2.34 respectively [31][36] - The company affirmed its total revenue guidance for 2025, maintaining a range of $4.15 billion to $4.4 billion, representing a 5% year-over-year growth at the midpoint [36][38] Business Line Data and Key Metrics Changes - The neuroscience portfolio, led by Xywav, generated approximately $431 million in total revenue, with Xywav net product sales at $345 million, a 9% increase year-over-year [12][8] - Epidiolex had net product sales of approximately $218 million, reflecting a 10% increase year-over-year, driven by underlying demand and favorable U.S. payer mix [15][17] - Oncology product sales were approximately $94 million, a decrease of 8% year-over-year, primarily due to changes in pediatric treatment protocols affecting Rylase sales [18][30] Market Data and Key Metrics Changes - The company reported approximately 14,600 active Xywav patients, with a net increase of 450 patients compared to Q4 2024, indicating strong market penetration [14] - The idiopathic hypersomnia market saw a 39% increase in patient adds over the last twelve months, reflecting successful disease education campaigns [90] Company Strategy and Development Direction - The company is focused on expanding its oncology portfolio, with a supplemental new drug application submitted for Zepzelca to include first-line maintenance therapy in extensive-stage small cell lung cancer [9][21] - The acquisition of Chimerix is expected to enhance the company's presence in rare oncology and provide a near-term commercial opportunity with doravaprone [10][25] - The company aims to maintain financial flexibility and operational excellence while navigating potential tariff impacts [11][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the top-line revenue guidance and highlighted the potential for growth in the oncology portfolio with upcoming regulatory approvals [11][36] - The company remains optimistic about the blockbuster potential of Epidiolex and the growth trajectory of Xywav, despite near-term headwinds in oncology [9][17] Other Important Information - The company is advancing its R&D pipeline, with key trials expected to read out in the second half of 2025, including the Horizon GEA-one Phase III trial [10][22] - The company has sufficient inventory to meet its 2025 needs, mitigating potential impacts from tariffs [33][34] Q&A Session Summary Question: Supply chain and Xywav production capabilities - The company confirmed it has a U.S. supplier for Xywav with sufficient capacity to meet U.S. needs, which could mitigate tariff exposure [46][47] Question: Manufacturing footprint and potential tariff impacts - The company has multiple manufacturing locations, including a U.S. CMO and facilities in Ireland and the UK, providing flexibility in response to potential tariffs [51][52] Question: Zepzelca's growth trajectory amidst competition - Management expects Zepzelca to return to growth, driven by upcoming data presentations and potential inclusion in treatment guidelines [59][60] Question: Chimerix acquisition rationale - The acquisition aligns with the company's strategy to address unmet medical needs in oncology and is expected to provide a near-term commercial opportunity [69][70] Question: Rylase growth in the adolescent and young adult market - Management indicated that education efforts are ongoing, and they expect normalization of Rylase revenues in the second quarter of 2025 [74][75]
Jazz Pharmaceuticals(JAZZ) - 2025 Q1 - Earnings Call Presentation
2025-05-06 20:21
May 6, 2025 2025 First Quarter Financial Results Innovating to Transform the Lives of Patients and Their Families 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 thereto, including with respect to tariffs, and anticipated catalysts; the Company's expectations for tot ...
Buy, Sell or Hold JAZZ Stock? Key Tips Ahead of Q1 Earnings
ZACKS· 2025-04-30 12:20
Jazz Pharmaceuticals (JAZZ) is set to report first-quarter 2025 earnings on May 6, after market close. The Zacks Consensus Estimate for the quarter’s sales and earnings is pegged at $978.6 million and $4.61 per share, respectively. The company’s earnings estimates for 2025 have risen from $23.12 per share to $23.33 in the past 60 days. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar) Image Source: Zacks Investment ResearchJAZZ’s Earnings Surprise HistoryJazz Pharmaceuticals’ performa ...