[Executive Summary](index=1&type=section&id=Executive%20Summary) Jazz Pharmaceuticals reported strong Q1 2025 revenues, affirmed full-year guidance, and advanced its pipeline with key acquisitions and regulatory submissions [First Quarter 2025 Performance Overview](index=1&type=section&id=First%20Quarter%202025%20Performance%20Overview) Jazz Pharmaceuticals reported total revenues of $898 million in Q1 2025, driven by strong performance from Xywav and Epidiolex, while affirming 2025 total revenue guidance and updating financial guidance to reflect recent acquisitions and litigation settlements - Total revenues reached **$898 million** in 1Q25, with Xywav and Epidiolex showing strong performance[1](index=1&type=chunk)[2](index=2&type=chunk) - Affirmed 2025 total revenue guidance range of **$4.15 - $4.40 billion**, reflecting confidence in commercial portfolio growth[2](index=2&type=chunk)[4](index=4&type=chunk) - Completed the acquisition of Chimerix, adding dordaviprone to the late-stage pipeline, and submitted an sNDA for Zepzelca in 1L ES-SCLC[1](index=1&type=chunk)[2](index=2&type=chunk) [Business Updates](index=1&type=section&id=Business%20Updates) The company experienced varied commercial performance across key products, completed a strategic acquisition, and advanced its late-stage pipeline with significant regulatory and clinical milestones [Commercial Updates](index=1&type=section&id=Commercial%20Updates) Commercial performance in Q1 2025 saw varied results across key products, with Xywav and Epidiolex/Epidyolex demonstrating strong growth, while other products experienced declines due to market competition or protocol updates Key Product Net Sales (1Q25 vs 1Q24) | Product | 1Q25 Net Sales ($M) | 1Q24 Net Sales ($M) | YoY Change | Key Driver/Impact | |---|---|---|---|---| | Xywav | 344.8 | 315.3 | +9% | Meaningful patient adds | | Xyrem | 37.2 | 64.2 | -42% | | | Epidiolex/Epidyolex | 217.7 | 198.7 | +10% | Confident in blockbuster status for 2025 | | Rylaze/Enrylaze | 94.2 | 102.7 | -8% | Headwinds from COG pediatric treatment protocol updates | | Zepzelca | 63.0 | 75.1 | -16% | Increased competition in 2L SCLC, treatment protocol updates | | Ziihera | 2.0 | — | N/A | Product launch in December 2024 | - Xywav added approximately **450 net patients** in 1Q25, reaching about **14,600 active patients**, and remains the 1 branded treatment for narcolepsy and the only FDA-approved therapy for IH[4](index=4&type=chunk)[6](index=6&type=chunk) - A supplemental New Drug Application (sNDA) for Zepzelca in combination with atezolizumab for maintenance therapy in 1L ES-SCLC was submitted, with potentially practice-changing data to be presented at ASCO 2025[4](index=4&type=chunk)[6](index=6&type=chunk) [Corporate Development](index=3&type=section&id=Corporate%20Development) Jazz Pharmaceuticals completed the acquisition of Chimerix in April 2025, integrating dordaviprone, a novel treatment for H3 K27M-mutant diffuse glioma, into its late-stage pipeline, addressing a significant unmet medical need - Acquisition of Chimerix completed in **April 2025**, adding dordaviprone to the late-stage pipeline[2](index=2&type=chunk)[4](index=4&type=chunk)[7](index=7&type=chunk) - Dordaviprone is a novel first-in-class small molecule treatment for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor[7](index=7&type=chunk) [Key Pipeline Highlights](index=3&type=section&id=Key%20Pipeline%20Highlights) The company made significant progress across its pipeline, with key updates for zanidatamab and dordaviprone, including pivotal trial readouts, FDA Priority Review, and ongoing Phase 3 evaluations - Top-line PFS data from the pivotal HERIZON-GEA-01 trial for zanidatamab in 1L gastroesophageal adenocarcinoma (GEA) is expected in **2H25**[2](index=2&type=chunk)[4](index=4&type=chunk)[12](index=12&type=chunk) - A New Drug Application (NDA) for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was accepted by FDA and granted Priority Review, with a PDUFA action date of **August 18, 2025**[4](index=4&type=chunk)[12](index=12&type=chunk) - The Phase 3 ACTION trial is evaluating dordaviprone in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients, potentially extending its use into the first-line setting[12](index=12&type=chunk) [Financial Results (Q1 2025)](index=3&type=section&id=Financial%20Results%20(Q1%202025)) Q1 2025 financial results show a GAAP net loss primarily due to Xyrem litigation settlements, stable total revenues, and increased operating expenses, while non-GAAP net income decreased [Financial Highlights](index=3&type=section&id=Financial%20Highlights) In Q1 2025, Jazz Pharmaceuticals reported a GAAP net loss of $(92.5) million, a significant increase from Q1 2024, primarily due to a $172.0 million expense related to Xyrem antitrust litigation settlements, while non-GAAP adjusted net income also decreased Q1 2025 Financial Highlights (GAAP & Non-GAAP) | Metric | 1Q25 (GAAP) | 1Q24 (GAAP) | 1Q25 (Non-GAAP) | 1Q24 (Non-GAAP) | |---|---|---|---|---| | Total revenues (in thousands) | $897,841 | $901,983 | N/A | N/A | | Net income (loss) (in thousands) | $(92,541) | $(14,618) | $105,233 | $178,430 | | EPS (LPS) | $(1.52) | $(0.23) | $1.68 | $2.63 | - GAAP net loss for 1Q25 was **$(92.5) million**, compared to **$(14.6) million** for 1Q24, primarily impacted by a **$172.0 million** expense from Xyrem antitrust litigation settlements[11](index=11&type=chunk)[13](index=13&type=chunk) - Non-GAAP adjusted net income for 1Q25 decreased to **$105.2 million** from **$178.4 million** in 1Q24[11](index=11&type=chunk) [Total Revenues Breakdown](index=4&type=section&id=Total%20Revenues%20Breakdown) Total revenues for Q1 2025 were $897.8 million, largely in line with Q1 2024, with Neuroscience revenue increasing due to Xywav and Epidiolex/Epidyolex sales, while Oncology net product sales decreased Total Revenues by Segment (1Q25 vs 1Q24) | Segment | 1Q25 ($M) | 1Q24 ($M) | YoY Change | |---|---|---|---| | Total Neuroscience (incl. royalties) | 654.1 | 630.9 | +4% | | Total Oncology | 229.4 | 257.5 | -11% | | Other | 4.8 | 3.6 | +33.3% | | **Total Revenues** | **897.8** | **902.0** | **-0.5%** | - Neuroscience revenue increase was driven by higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales[15](index=15&type=chunk) - Oncology net product sales decrease was primarily due to lower sales of Zepzelca, Rylaze/Enrylaze, and Defitelio/defibrotide, with Rylaze impacted by COG pediatric treatment protocol updates[16](index=16&type=chunk) [Operating Expenses and Effective Tax Rate](index=5&type=section&id=Operating%20Expenses%20and%20Effective%20Tax%20Rate) Operating expenses in Q1 2025 increased due to product mix changes, higher inventory provisions, and Xyrem antitrust litigation settlements, while R&D expenses decreased, and the GAAP effective tax rate was significantly influenced by the Xyrem settlements Operating Expenses (GAAP) (1Q25 vs 1Q24) | Expense Category | 1Q25 ($M) | 1Q24 ($M) | YoY Change | |---|---|---|---| | Cost of product sales | 104.6 | 95.5 | +9.5% | | Selling, general and administrative | 514.0 | 351.7 | +46.1% | | Research and development | 180.7 | 222.8 | -18.9% | | Acquired in-process R&D | — | 10.0 | -100% | | Income tax (benefit) expense | (17.8) | 11.7 | N/A | | Effective tax rate | 16.2% | (728.4)% | N/A | - SG&A expenses increased significantly due to **$172.0 million** in Xyrem antitrust litigation settlements[19](index=19&type=chunk) - R&D expenses decreased primarily due to lower clinical study costs for zanidatamab and the discontinuation of JZP385 and JZP150 programs[19](index=19&type=chunk) [Cash Flow and Balance Sheet](index=6&type=section&id=Cash%20Flow%20and%20Balance%20Sheet) Jazz Pharmaceuticals maintained strong liquidity with $2.6 billion in cash, generated $429.8 million from operations, and reduced long-term debt through a $750 million prepayment Key Financial Position & Cash Flow (as of March 31, 2025) | Metric | Amount ($B) | |---|---| | Cash, cash equivalents and investments | 2.6 | | Outstanding principal balance of long-term debt | 5.4 | | Undrawn revolving credit facility | 0.885 | | Cash from operations (1Q25) | 0.430 | - Generated **$429.8 million** of cash from operations in 1Q25, reflecting strong business performance[20](index=20&type=chunk) - Made a voluntary prepayment of **$750.0 million** principal amount on the Term Loan B in January 2025[20](index=20&type=chunk) [2025 Financial Guidance](index=6&type=section&id=2025%20Financial%20Guidance) Jazz Pharmaceuticals updated its 2025 financial guidance to reflect the Chimerix acquisition and Xyrem litigation settlements, affirming revenue but significantly revising net income and EPS projections downwards [Overall Guidance Update](index=6&type=section&id=Overall%20Guidance%20Update) Jazz Pharmaceuticals updated its full-year 2025 financial guidance primarily to incorporate the impact of the Chimerix acquisition and certain Xyrem antitrust litigation settlements, resulting in affirmed total revenue guidance but significantly revised GAAP and Non-GAAP net income and EPS projections - Updated 2025 financial guidance to reflect the Chimerix acquisition and Xyrem antitrust litigation settlements[21](index=21&type=chunk) - Total revenue guidance for 2025 remains affirmed at **$4.15 - $4.40 billion**[22](index=22&type=chunk) - The acquired IPR&D expense from the Chimerix acquisition (**$885.0 million** at midpoint) and Xyrem antitrust litigation settlements (**$172.0 million**) are expected to impact GAAP and non-GAAP projected results by **$1.0 billion**[25](index=25&type=chunk)[27](index=27&type=chunk) [GAAP Guidance](index=6&type=section&id=GAAP%20Guidance) The updated GAAP guidance for 2025 projects a net loss of $(615) - $(450) million, a significant change from previous net income projections, primarily driven by acquired IPR&D expense from the Chimerix acquisition and Xyrem antitrust litigation settlements 2025 GAAP Financial Guidance Comparison | Metric | May 6, 2025 Guidance | February 25, 2025 Guidance | |---|---|---| | SG&A expenses ($M) | $1,640 - $1,723 | $1,404 - $1,483 | | R&D expenses ($M) | $835 - $895 | $792 - $851 | | Acquired in-process R&D ($M) | $870 - $900 | - | | Net income (loss) ($M) | $(615) - $(450) | $560 - $720 | | Net income (loss) per diluted share | $(10.00) - $(7.50) | $9.15 - $11.50 | - The projected GAAP net loss includes an acquired IPR&D expense of **$885.0 million** (midpoint) relating to the Chimerix acquisition and **$172.0 million** for Xyrem antitrust litigation settlements[25](index=25&type=chunk) [Non-GAAP Guidance](index=7&type=section&id=Non-GAAP%20Guidance) The updated Non-GAAP guidance for 2025 shows a substantial reduction in projected net income to $250 - $350 million, primarily due to the inclusion of acquired IPR&D expense and Xyrem antitrust litigation settlements, which also significantly impacted the non-GAAP effective tax rate 2025 Non-GAAP Financial Guidance Comparison | Metric | May 6, 2025 Guidance | February 25, 2025 Guidance | |---|---|---| | SG&A expenses ($M) | $1,470 - $1,530 | $1,250 - $1,310 | | R&D expenses ($M) | $760 - $810 | $720 - $770 | | Acquired in-process R&D ($M) | $870 - $900 | - | | Effective tax rate | 35% - 45% | 13% - 15% | | Net income ($M) | $250 - $350 | $1,400 - $1,500 | | Net income per diluted share | $4.00 - $5.60 | $22.50 - $24.00 | - The non-GAAP adjusted net income guidance includes the acquired IPR&D expense from the Chimerix acquisition and Xyrem antitrust litigation settlements, leading to a significant downward revision[25](index=25&type=chunk)[27](index=27&type=chunk) - The non-GAAP effective tax rate is projected to be **35% - 45%**, a substantial increase from the previous guidance of **13% - 15%**[24](index=24&type=chunk)[31](index=31&type=chunk) [Additional Information](index=7&type=section&id=Additional%20Information) This section provides details on the Q1 2025 conference call, an overview of Jazz Pharmaceuticals, explanations of non-GAAP financial measures, and cautions regarding forward-looking statements [Conference Call Details](index=7&type=section&id=Conference%20Call%20Details) Jazz Pharmaceuticals hosted an investor conference call and live audio webcast on May 6, 2025, at 4:30 p.m. ET to discuss Q1 2025 results and provide a business and financial update, with a replay available online - Conference call and live audio webcast held on **May 6, 2025**, at **4:30 p.m. ET** to discuss Q1 2025 results[28](index=28&type=chunk) - A replay of the webcast is available via the Investors section of the Jazz Pharmaceuticals website[30](index=30&type=chunk) [About Jazz Pharmaceuticals](index=8&type=section&id=About%20Jazz%20Pharmaceuticals) Jazz Pharmaceuticals plc is a global biopharmaceutical company focused on developing life-changing medicines for serious diseases, particularly in sleep disorders, epilepsy, and oncology, with a patient-focused, science-driven approach to R&D - Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for serious diseases[32](index=32&type=chunk) - The company has a diverse portfolio of marketed medicines, including leading therapies for sleep disorders, epilepsy, and a growing portfolio of cancer treatments[32](index=32&type=chunk) - Headquartered in Dublin, Ireland, with R&D labs, manufacturing facilities, and employees worldwide[32](index=32&type=chunk) [Non-GAAP Financial Measures](index=8&type=section&id=Non-GAAP%20Financial%20Measures) Jazz Pharmaceuticals uses non-GAAP adjusted financial measures to supplement GAAP results, excluding items like intangible asset amortization and share-based compensation, to provide useful supplementary information for investors and analysts, with an updated adjustment policy for Q1 2025 - Non-GAAP measures are used to supplement GAAP results, providing useful supplementary information for investors and analysts[33](index=33&type=chunk)[34](index=34&type=chunk) - Non-GAAP adjustments exclude items such as intangible asset amortization, share-based compensation expense, and acquisition accounting inventory fair value step-up[33](index=33&type=chunk)[48](index=48&type=chunk)[50](index=50&type=chunk) - Commencing with **Q1 2025**, the company no longer includes an adjustment for non-cash interest expense in its non-GAAP adjusted financial measures[34](index=34&type=chunk) [Caution Concerning Forward-Looking Statements](index=9&type=section&id=Caution%20Concerning%20Forward-Looking%20Statements) This section highlights that the press release contains forward-looking statements regarding future financial results, pipeline advancements, regulatory activities, and commercialization strategies, which are subject to significant risks and uncertainties that could cause actual results to differ materially - The press release contains forward-looking statements related to 2025 financial guidance, pipeline advancements, regulatory activities, and commercialization strategies[36](index=36&type=chunk) - These statements are subject to significant risks and uncertainties, including maintaining sales, new product competition, regulatory approval processes, clinical trial success, and macroeconomic conditions[36](index=36&type=chunk)[37](index=37&type=chunk) - Actual results and timing of events could differ materially from those anticipated due to these risks, as detailed in SEC filings[37](index=37&type=chunk)[38](index=38&type=chunk) [Condensed Consolidated Financial Statements](index=11&type=section&id=Condensed%20Consolidated%20Financial%20Statements) The condensed financial statements detail Q1 2025 performance, showing a net loss, changes in assets and liabilities, and cash flow activities, with reconciliations to non-GAAP measures [Condensed Consolidated Statements of Loss](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss) The condensed consolidated statements of loss show a net loss of $(92.5) million for Q1 2025, compared to $(14.6) million for Q1 2024, with stable total revenues but significantly increased operating expenses Condensed Consolidated Statements of Loss (1Q25 vs 1Q24) | Metric (in thousands) | 1Q25 | 1Q24 | |---|---|---| | Total revenues | $897,841 | $901,983 | | Total operating expenses | $953,733 | $835,776 | | Income (loss) from operations | $(55,892) | $66,207 | | Net loss | $(92,541) | $(14,618) | | Net loss per ordinary share (basic and diluted) | $(1.52) | $(0.23) | - Selling, general and administrative expenses increased from **$351.7 million** in 1Q24 to **$514.0 million** in 1Q25[41](index=41&type=chunk) - Research and development expenses decreased from **$222.8 million** in 1Q24 to **$180.7 million** in 1Q25[41](index=41&type=chunk) [Condensed Consolidated Balance Sheets](index=12&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $11.5 billion from $12.0 billion at December 31, 2024, primarily due to a decrease in cash and cash equivalents, while total liabilities also decreased, driven by a reduction in long-term debt Condensed Consolidated Balance Sheets (March 31, 2025 vs December 31, 2024) | Metric (in thousands) | March 31, 2025 | December 31, 2024 | |---|---|---| | Cash and cash equivalents | $1,861,946 | $2,412,864 | | Total current assets | $4,127,817 | $4,629,028 | | Total assets | $11,534,682 | $12,012,257 | | Total current liabilities | $1,222,610 | $1,038,573 | | Long-term debt, less current portion | $5,336,481 | $6,077,640 | | Total shareholders' equity | $4,174,891 | $4,093,756 | - Cash and cash equivalents decreased by over **$550 million** from December 31, 2024, to March 31, 2025[44](index=44&type=chunk) - Long-term debt, less current portion, decreased by approximately **$741 million**[44](index=44&type=chunk) [Summary of Cash Flows](index=12&type=section&id=Summary%20of%20Cash%20Flows) For Q1 2025, net cash provided by operating activities significantly increased to $429.8 million, but net cash used in financing activities also increased substantially due to debt prepayments, resulting in a net decrease in cash and cash equivalents Summary of Cash Flows (1Q25 vs 1Q24) | Cash Flow Activity (in thousands) | 1Q25 | 1Q24 | |---|---|---| | Net cash provided by operating activities | $429,784 | $267,229 | | Net cash used in investing activities | $(168,931) | $(271,904) | | Net cash used in financing activities | $(813,466) | $(56,552) | | Net decrease in cash and cash equivalents | $(550,918) | $(62,925) | - Net cash provided by operating activities increased by over **60%** year-over-year[46](index=46&type=chunk) - Net cash used in financing activities increased significantly, indicating substantial outflows, likely for debt reduction[46](index=46&type=chunk) [Reconciliations of GAAP Reported to Non-GAAP Adjusted Information](index=13&type=section&id=Reconciliations%20of%20GAAP%20Reported%20to%20Non-GAAP%20Adjusted%20Information) This section provides detailed reconciliations between GAAP reported figures and non-GAAP adjusted figures for Q1 2025 and Q1 2024, as well as for the 2025 full-year guidance, highlighting how key adjustments significantly impact net income and EPS GAAP to Non-GAAP Reconciliation (1Q25) | Metric (in thousands) | GAAP Reported | Adjustments | Non-GAAP Adjusted | |---|---|---|---| | Net Income (Loss) | $(92,541) | $197,774 | $105,233 | | Diluted EPS/(LPS) | $(1.52) | $3.20 | $1.68 | | Cost of product sales | $104,620 | $(34,929) | $69,691 | | SG&A | $514,013 | $(41,674) | $472,339 | | R&D | $180,652 | $(20,930) | $159,722 | - Key non-GAAP adjustments for Q1 2025 include **$154.4 million** for intangible asset amortization, **$67.7 million** for share-based compensation expense, and **$29.9 million** for acquisition accounting inventory fair value step-up[48](index=48&type=chunk) - The reconciliation for 2025 guidance shows a significant impact from intangible asset amortization (**$610-$660 million**) and acquired IPR&D (**$870-$900 million**) on the shift from GAAP net loss to non-GAAP adjusted net income[53](index=53&type=chunk)

Core Insights - Jazz Pharmaceuticals plc will participate in the BofA Securities 2025 Healthcare Conference on May 14, 2025 [1] - An audio webcast of the fireside chat will be available on the company's investor website and archived for 30 days [2] Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for serious diseases with limited therapeutic options [3] - The company has a diverse portfolio, including leading therapies for sleep disorders, epilepsy, and a growing range of cancer treatments [3] - Jazz is headquartered in Dublin, Ireland, with research and development facilities and manufacturing sites in multiple countries [3]

Core Viewpoint - Jazz Pharmaceuticals is expected to report first-quarter 2025 earnings on May 6, with sales estimated at $978.6 million and earnings at $4.61 per share, reflecting a positive trend in earnings estimates for 2025 [1][3]. Financial Performance - Jazz Pharmaceuticals has exceeded earnings expectations in three of the last four quarters, with a trailing four-quarter average earnings surprise of 3.20% and a notable earnings surprise of 13.99% in the last quarter [3]. - The company currently has an Earnings ESP of -2.75% and a Zacks Rank of 3 (Hold) [5]. Revenue Segments - The company reports financial figures under two segments: Neuroscience and Oncology. The consensus estimate for neuroscience product sales is $649 million, while the estimate for oncology sales is $269 million [7][10]. - Sales of the sleep disorder drug Xywav are projected at $372 million, with expectations of continued growth due to its uptake in narcolepsy and idiopathic hypersomnia [8]. - Epidiolex sales are expected to rise to $234 million, driven by geographic expansion, while sales of the legacy drug Xyrem are anticipated to decline [9]. Oncology Performance - Sales of the chemotherapy drug Rylaze are expected to be impacted by recent updates to treatment protocols, with estimates pegged at $103 million [11]. - Other oncology drugs, including Zepzelca, Vyxeos, and Defitelio, are expected to grow at a mid-single-digit percentage during the quarter [11]. Stock Performance and Valuation - Jazz Pharmaceuticals' shares have declined about 6% year-to-date, compared to a 4% decline in the industry, and are currently trading below their 50-day and 200-day moving averages [13]. - The stock is trading at a price-to-sales (P/S) ratio of 1.76, lower than the industry average of 1.97 and below its five-year mean of 2.70, indicating a valuation discount [16]. Investment Thesis - The company has a diversified portfolio in neuroscience and oncology, although pipeline setbacks, such as the discontinuation of suvecaltamide development, pose concerns [18]. - Strategic acquisitions have bolstered the pipeline, with five oncology products marketed and an FDA decision on a sixth product expected by August 18 [19][20]. - Despite challenges, the rising EPS estimates for 2025 and a robust cash reserve of $3.0 billion at the end of 2024 provide reasons to remain invested in Jazz Pharmaceuticals [21].

DUBLIN, April 25, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+ ...

Core Insights - Jazz Pharmaceuticals is presenting significant clinical trial data at the ASCO Annual Meeting, highlighting the potential of Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for first-line maintenance therapy in extensive-stage small cell lung cancer (ES-SCLC) [1][2] - The company is also showcasing long-term outcomes for Ziihera® (zanidatamab-hrii) in HER2-positive gastroesophageal cancer, indicating its potential to change treatment paradigms [1][2] - Efficacy and safety data for dordaviprone (ONC201) in recurrent H3 K27M-mutant diffuse glioma patients are also being presented, addressing a significant unmet medical need [1][2] Group 1: Zepzelca® (lurbinectedin) - The Phase 3 IMforte trial data shows statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) for Zepzelca in combination with atezolizumab for ES-SCLC patients [2][4] - The FDA has received a supplemental New Drug Application based on this trial data, marking a milestone for Zepzelca's approval process [2][4] - An investor webcast is scheduled for June 10 to review Zepzelca data, featuring commentary from experts [3] Group 2: Ziihera® (zanidatamab-hrii) - Updated long-term outcomes and median overall survival findings from the Phase 2 trial of Ziihera in combination with chemotherapy for HER2-positive metastatic gastroesophageal adenocarcinoma will be presented [2][4] - Ziihera is positioned as a differentiated HER2-targeted therapy, with further Phase 3 findings expected later this year [2][4] Group 3: Dordaviprone (ONC201) - New efficacy and safety findings for dordaviprone in adult and pediatric patients with recurrent H3 K27M-mutant diffuse glioma are being highlighted [2][4] - The drug addresses a significant unmet need, as there are currently no FDA-approved therapies for this patient population [2][4] Group 4: Company Overview - Jazz Pharmaceuticals is committed to advancing targeted treatment options that address pressing patient needs, with a focus on oncology and neuroscience [55] - The company has a diverse portfolio of marketed medicines and is dedicated to developing potentially life-changing therapies for serious diseases [55]

Group 1 - Jazz Pharmaceuticals plc will report its 2025 first quarter financial results on May 6, 2025, after the U.S. financial markets close [1] - A live audio webcast will be hosted by company management at 4:30 p.m. ET / 9:30 p.m. IST to discuss the financial results and provide a business update [1] - Interested parties can access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website [2] Group 2 - Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for serious diseases with limited therapeutic options [4] - The company has a diverse portfolio of marketed medicines, including therapies for sleep disorders, epilepsy, and a growing portfolio of cancer treatments [4] - Jazz Pharmaceuticals is headquartered in Dublin, Ireland, with research and development laboratories and manufacturing facilities in multiple countries [4]

Core Insights - Jazz Pharmaceuticals has successfully acquired Chimerix, Inc. for approximately $935 million in cash, enhancing its oncology pipeline and commitment to addressing rare diseases with significant unmet needs [1][2][3] Acquisition Details - The acquisition was completed through a tender offer for Chimerix's outstanding shares at $8.55 per share, which expired on April 17, 2025 [3] - Following the acquisition, Chimerix became a wholly owned subsidiary of Jazz Pharmaceuticals [3] Product Development - The acquisition includes dordaviprone, a novel first-in-class small molecule treatment for H3 K27M-mutant diffuse glioma, which is currently under Priority Review by the FDA with a PDUFA action date set for August 18, 2025 [2][4] - If approved, dordaviprone may be the first FDA-approved therapy for this specific type of glioma and could offer a promising near-term commercial opportunity [2][4] Clinical Trials - Dordaviprone is being evaluated in the ongoing Phase 3 ACTION trial for newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially expanding its use into first-line settings [2][4] Company Overview - Jazz Pharmaceuticals is a global biopharmaceutical company focused on developing life-changing medicines for serious diseases, with a diverse portfolio that includes therapies for sleep disorders, epilepsy, and cancer treatments [5]

Core Viewpoint - Jazz Pharmaceuticals and Harmony Biosciences are significant players in the neuroscience sector, particularly in sleep disorders, with Jazz having a more diversified portfolio and stronger financial performance compared to Harmony [1][2][22]. Group 1: Company Overview - Jazz Pharmaceuticals markets several neuroscience drugs, including the oral sleep disorder drug Xywav and the CBD drug Epidiolex, while Harmony Biosciences has one marketed drug, Wakix, for narcolepsy [1][10]. - Jazz derives over two-thirds of its total revenues from its neuroscience franchise, while Harmony generates all its revenue from Wakix sales [3][11]. Group 2: Financial Performance - Jazz's total revenues for 2024 rose 6% year over year to $4.1 billion, with $2.9 billion from neuroscience and $1.1 billion from oncology drugs [9]. - Harmony's 2024 sales increased 23% year over year to $715 million, with expectations for 2025 sales between $820 million and $860 million, indicating an 18% year-over-year growth [11]. Group 3: Product Pipeline and Development - Jazz's Xywav sales rose 16% year over year to $1.5 billion in 2024, and Epidiolex sales increased 15% year over year to $972 million [4][5]. - Harmony is developing next-generation formulations of Wakix and has acquired Zynerba Pharmaceuticals to explore the cannabis space [12][13]. Group 4: Market Position and Valuation - Jazz has a diversified product lineup, including five oncology drugs, which accounted for 29% of its 2024 product revenues [6]. - Harmony's shares trade at a higher price/earnings (P/E) ratio of 8.63 compared to Jazz's 5.07, indicating that Harmony is more expensive [19]. Group 5: Investment Outlook - Jazz is viewed as a better investment option due to its diversified portfolio, rising EPS estimates, and robust cash reserves, while Harmony's reliance on a single product presents a concentration risk [22][23]. - Jazz holds a Zacks Rank 2 (Buy), while Harmony has a Zacks Rank 3 (Hold), reinforcing Jazz's favorable investment standing [24].

Core Viewpoint - Investors are evaluating the value opportunities presented by Jazz Pharmaceuticals (JAZZ) and argenex SE (ARGX), with JAZZ currently appearing to offer superior value based on various valuation metrics [1][7]. Valuation Metrics - JAZZ has a forward P/E ratio of 4.35, significantly lower than ARGX's forward P/E of 46.77, indicating that JAZZ may be undervalued [5]. - The PEG ratio for JAZZ is 0.60, while ARGX has a PEG ratio of 1.44, suggesting that JAZZ has a more favorable growth outlook relative to its valuation [5]. - JAZZ's P/B ratio stands at 1.50, compared to ARGX's P/B of 6.49, further supporting the notion that JAZZ is undervalued relative to its book value [6]. Earnings Outlook - Both JAZZ and ARGX hold a Zacks Rank of 2 (Buy), indicating positive earnings estimate revisions for both companies, which reflects an improving earnings outlook [3].

Company Overview - Jazz Pharmaceuticals (JAZZ) shares increased by 7.1% to close at $110.12, following a significant volume of trading, contrasting with a 24.9% loss over the past four weeks [1] - The rise in share price was influenced by President Trump's announcement of a 90-day pause on tariffs against non-retaliating countries [1] Earnings Expectations - Jazz is projected to report quarterly earnings of $4.65 per share, reflecting a year-over-year increase of 73.5% [2] - Expected revenues for the upcoming quarter are $978.58 million, which is an 8.5% increase compared to the same quarter last year [2] Earnings Estimate Revisions - The consensus EPS estimate for Jazz has been revised 3.2% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [3] - The stock currently holds a Zacks Rank of 2 (Buy), suggesting favorable market sentiment [3] Industry Context - Jazz operates within the Zacks Medical - Biomedical and Genetics industry, where Novavax (NVAX) also competes [3] - Novavax's consensus EPS estimate has increased by 7.6% over the past month to -$0.43, representing a 59.1% change from the previous year [4] - Novavax currently holds a Zacks Rank of 3 (Hold), indicating a more cautious outlook compared to Jazz [4]