Core Viewpoint - The performance of Jazz Pharmaceuticals' international operations is critical for understanding its financial strength and growth potential, especially in the context of a tightly interconnected global economy [2][3]. Group 1: International Revenue Performance - Jazz Pharmaceuticals reported total revenue of $1.05 billion for the quarter, reflecting a 2.1% increase [4]. - Revenue from Europe was $82.76 million, accounting for 7.9% of total revenue, which was a surprise of -2.2% compared to the consensus estimate of $84.62 million [5]. - Revenue from "All other regions" was $26.67 million, representing 2.6% of total revenue, with a positive surprise of +15.84% against an expected $23.02 million [6]. Group 2: Future Revenue Projections - Analysts project total revenue for the current fiscal quarter to reach $1.1 billion, indicating a 4.7% increase from the same quarter last year [7]. - For the entire year, total revenue is forecasted at $4.21 billion, which is a 3.4% improvement from the previous year [8]. - Expected contributions from Europe and "All other regions" for the year are $351.93 million (8.4%) and $91.76 million (2.2%), respectively [8]. Group 3: Market Dynamics and Stock Performance - The reliance on international markets presents both opportunities and challenges for Jazz Pharmaceuticals, making it essential to track international revenue trends for future projections [9]. - Over the past month, Jazz's stock has declined by 0.4%, while the S&P 500 composite increased by 1.9% [13]. - In the last three months, Jazz's stock price increased by 5.7%, compared to a 13% rise in the S&P 500 index [13].

Core Insights - Jazz Pharmaceuticals has received FDA accelerated approval for Modeyso™ (dordaviprone) as the first treatment for H3 K27M-mutant diffuse midline glioma, primarily affecting children and young adults [1][2] - Modeyso is expected to be commercially available in the coming weeks, addressing an urgent unmet need for patients with this aggressive brain tumor [1][2] - The approval is based on a clinical analysis of 50 patients, showing an overall response rate of 22% and a median duration of response of 10.3 months [2][7] Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing innovative medicines for serious diseases with limited treatment options [21] - The company aims to transform the lives of patients and their families through a patient-focused and science-driven approach [21] Product Details - Modeyso is an orally administered small molecule given once weekly, targeting the specific genetic mutation associated with the tumor [7] - The ongoing Phase 3 ACTION trial will further evaluate the clinical benefit of Modeyso in newly diagnosed patients [7] Clinical Data - The FDA's decision was based on an integrated efficacy analysis from five open-label clinical studies, with serious adverse reactions reported in 33% of patients [2][3] - Among responders, 73% maintained their response for at least six months, and 27% for at least 12 months [2] Market Impact - The approval of Modeyso represents a significant advancement in neuro-oncology, providing a new treatment option for a population with historically limited choices [2][6] - The estimated annual incidence of H3 K27M-mutant diffuse midline glioma in the U.S. is around 2,000 cases [1][6]

Key Takeaways Jazz Pharmaceuticals (JAZZ) reported second-quarter 2025 adjusted loss of $8.25 per share, wider than the Zacks Consensus Estimate of a loss of $6.12. This downtick was primarily due to a one-time charge incurred by the company for the acquisition of clinical-stage biotech Chimerix, completed in April, which impacted the bottom line by $14.75 per share. In the year-ago period, the company reported adjusted earnings per share (EPS) of $5.25. Total revenues rose 2% year over year to $1.05 billio ...

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's discussion, market risk, and controls [Defined Terms and Products](index=3&type=section&id=Defined%20Terms%20and%20Products) This section provides a comprehensive glossary of defined terms and product names used throughout the Form 10-Q, covering financial, regulatory, disease-state, and company-specific terminology, as well as brand names of the company's products and product candidates [Defined Terms](index=4&type=section&id=Defined%20terms) This subsection clarifies various financial, legal, regulatory, and medical terms essential for understanding the Form 10-Q - The report defines various financial instruments (e.g., 2024 Notes, 2026 Notes, 2030 Notes), legal proceedings (e.g., AFL Plan Lawsuit, BCBS Lawsuit, Chimerix Shareholder Litigation), regulatory bodies (e.g., FDA, SEC, EC), and medical terms (e.g., ALL, AML, EDS, IH, SCLC, TSC) to ensure clarity and consistency[9](index=9&type=chunk)[10](index=10&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) [Products](index=7&type=section&id=Products) This subsection lists key product brand names and their generic names, providing a quick reference for the company's portfolio - Key product brand names and their associated generic names include CombiPlex, Defitelio (defibrotide sodium), dordaviprone (ONC201), Epidiolex (cannabidiol), Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), Sativex (nabiximols), Suvecaltamide (JZP385), Vyxeos (daunorubicin and cytarabine), Xyrem (sodium oxybate), Xywav (calcium, magnesium, potassium, and sodium oxybates), Zepzelca (lurbinectedin), and Ziihera (zanidatamab-hrii)[13](index=13&type=chunk)[14](index=14&type=chunk)[15](index=15&type=chunk) [Item 1. Financial Statements](index=8&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Jazz Pharmaceuticals plc, including the balance sheets, statements of income (loss), comprehensive income (loss), shareholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, recent acquisitions, debt, and legal proceedings [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This subsection provides a snapshot of the company's financial position, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheets (June 30, 2025 vs. December 31, 2024) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $1,189,880 | $2,412,864 | | Investments | $480,000 | $580,000 | | Total current assets | $3,350,433 | $4,629,028 | | Total assets | $10,944,141 | $12,012,257 | | **LIABILITIES & EQUITY** | | | | Current portion of long-term debt | $1,028,478 | $31,000 | | Long-term debt, less current portion | $4,335,616 | $6,077,640 | | Total current liabilities | $2,071,205 | $1,038,573 | | Total shareholders' equity | $3,706,359 | $4,093,756 | | Total liabilities and shareholders' equity | $10,944,141 | $12,012,257 | - Total assets decreased by approximately **$1.07 billion** from December 31, 2024, to June 30, 2025, primarily driven by a significant reduction in cash and cash equivalents[17](index=17&type=chunk) - Current portion of long-term debt increased substantially from **$31.0 million** to **$1.03 billion**, indicating a significant amount of debt becoming due within the next year[17](index=17&type=chunk) [Condensed Consolidated Statements of Income (Loss)](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income%20(Loss)) This subsection outlines the company's financial performance, reporting revenues, expenses, and net income or loss Condensed Consolidated Statements of Income (Loss) (Three and Six Months Ended June 30, 2025 vs. 2024) | Metric (in thousands, except per share) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :------------------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total revenues | $1,045,712 | $1,023,825 | $1,943,553 | $1,925,808 | | Total operating expenses | $1,732,104 | $824,382 | $2,685,837 | $1,660,158 | | Income (loss) from operations | $(686,392) | $199,443 | $(742,284) | $265,650 | | Net income (loss) | $(718,470) | $168,568 | $(811,011) | $153,950 | | Basic EPS | $(11.74) | $2.68 | $(13.28) | $2.45 | | Diluted EPS | $(11.74) | $2.49 | $(13.28) | $2.35 | - The company reported a significant net loss of **$718.47 million** for the three months ended June 30, 2025, and **$811.01 million** for the six months ended June 30, 2025, a substantial decline from net income in the prior year periods. This was primarily driven by a large increase in 'Acquired in-process research and development' expense of **$905.36 million** in 2025[20](index=20&type=chunk) [Condensed Consolidated Statements of Comprehensive Income (Loss)](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%20(Loss)) This subsection presents total comprehensive income or loss, including net income and other comprehensive income items Condensed Consolidated Statements of Comprehensive Income (Loss) (Three and Six Months Ended June 30, 2025 vs. 2024) | Metric (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net income (loss) | $(718,470) | $168,568 | $(811,011) | $153,950 | | Other comprehensive income (loss) | $299,842 | $(5,833) | $461,899 | $(46,080) | | Total comprehensive income (loss) | $(418,628) | $162,735 | $(349,112) | $107,870 | - Total comprehensive loss for the six months ended June 30, 2025, was **$349.11 million**, a significant decrease from a comprehensive income of **$107.87 million** in the prior year, primarily due to the net loss, partially offset by positive foreign currency translation adjustments[22](index=22&type=chunk) [Condensed Consolidated Statements of Shareholders' Equity](index=14&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity) This subsection details changes in the company's equity, including net income, share repurchases, and other comprehensive income Condensed Consolidated Statements of Shareholders' Equity (June 30, 2025 vs. December 31, 2024) | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Total Shareholders' Equity | $4,093,756 | $3,706,359 | | Net Loss | N/A | $(718,470) | | Shares Repurchased | N/A | $(125,023) | | Other Comprehensive Income | N/A | $299,842 | - Total shareholders' equity decreased from **$4.09 billion** at December 31, 2024, to **$3.71 billion** at June 30, 2025, primarily due to the net loss incurred and share repurchases, partially offset by other comprehensive income[24](index=24&type=chunk)[25](index=25&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=16&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This subsection reports cash generated and used by the company across operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30, 2025 vs. 2024) | Metric (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------- | :-------------------------- | :-------------------------- | | Net cash provided by operating activities | $518,639 | $598,581 | | Net cash used in investing activities | $(809,951) | $(528,995) | | Net cash used in financing activities | $(937,991) | $(217,637) | | Net decrease in cash and cash equivalents | $(1,222,984) | $(150,508) | | Cash and cash equivalents, at end of period | $1,189,880 | $1,355,802 | - Net cash provided by operating activities decreased by **$79.9 million**, primarily due to Xyrem antitrust litigation settlements of **$172.0 million** in 2025[28](index=28&type=chunk)[231](index=231&type=chunk) - Net cash used in investing activities increased by **$281.0 million**, largely due to the **$858.1 million** cash outflow for the Chimerix Acquisition and a **$25.0 million** milestone payment to Zymeworks[28](index=28&type=chunk)[232](index=232&type=chunk)[235](index=235&type=chunk) - Net cash used in financing activities increased by **$720.4 million**, driven by a **$750.0 million** voluntary repayment on the Tranche B-2 Dollar Term Loan and increased employee withholding taxes related to share-based awards[28](index=28&type=chunk)[232](index=232&type=chunk)[235](index=235&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=17&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This subsection provides detailed explanations and supplementary information for financial statements, covering policies, debt, and contingencies [1. The Company and Summary of Significant Accounting Policies](index=17&type=section&id=1.%20The%20Company%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note describes Jazz Pharmaceuticals' business, focus areas, key products, and significant accounting principles - Jazz Pharmaceuticals is a global biopharmaceutical company focused on developing life-changing medicines for serious diseases, with a diverse portfolio in sleep disorders, epilepsy, and cancer treatments[30](index=30&type=chunk) - Key marketed products include Xywav (narcolepsy, IH), Epidiolex/Epidyolex (epilepsy), Rylaze/Enrylaze (ALL/LBL), Zepzelca (SCLC), and Ziihera (HER2-positive BTC)[36](index=36&type=chunk) - The company operates in one business segment: identification, development, and commercialization of pharmaceutical products addressing unmet medical needs[40](index=40&type=chunk) - Significant risks include dependence on oxybate revenues, competition from generic oxybate products (Lumryz, AG versions), challenges in commercializing Epidiolex/Epidyolex, and risks associated with R&D, regulatory approvals, and product pricing scrutiny[43](index=43&type=chunk)[44](index=44&type=chunk)[46](index=46&type=chunk) [2. Asset Acquisition](index=20&type=section&id=2.%20Asset%20Acquisition) This note details the Chimerix acquisition, including consideration paid and allocation of acquired assets and liabilities - On April 21, 2025, Jazz Pharmaceuticals acquired Chimerix for a total cash consideration of **$944.2 million**, funded by cash and cash equivalents. The acquisition was accounted for as an asset acquisition[53](index=53&type=chunk) Chimerix Acquisition Consideration and Net Assets Acquired (in thousands) | Item | Amount | | :------------------------------------ | :------- | | Cash consideration for common stock | $802,023 | | Cash consideration for equity awards | $142,131 | | **Total cash consideration paid** | **$944,154** | | Transaction costs | $13,237 | | **Total consideration** | **$957,391** | | Cash acquired | $99,338 | | In-process research and development | $905,362 | | Accrued liabilities | $(53,066) | | Other assets and liabilities | $5,757 | | **Total net assets acquired** | **$957,391** | - The value attributed to in-process research and development (dordaviprone) was expensed as it had no alternative future use[54](index=54&type=chunk) [3. Cash and Available-for-Sale Securities](index=20&type=section&id=3.%20Cash%20and%20Available-for-Sale%20Securities) This note provides a breakdown of cash, cash equivalents, and investment holdings, along with related interest income Cash, Cash Equivalents and Investments (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Cash | $672,211 | $948,894 | | Time deposits | $480,000 | $790,000 | | Money market funds | $517,669 | $1,253,970 | | **Totals** | **$1,669,880** | **$2,992,864** | | Cash and cash equivalents | $1,189,880 | $2,412,864 | | Investments | $480,000 | $580,000 | - Total cash, cash equivalents, and investments decreased by approximately **$1.32 billion** from December 31, 2024, to June 30, 2025[55](index=55&type=chunk)[56](index=56&type=chunk) Interest Income from Available-for-Sale Securities (in millions) | Period | 2025 (3 Months) | 2024 (3 Months) | 2025 (6 Months) | 2024 (6 Months) | | :-------------------- | :-------------- | :-------------- | :-------------- | :-------------- | | Interest income | $19.1 | $25.4 | $46.8 | $48.6 | [4. Fair Value Measurement](index=21&type=section&id=4.%20Fair%20Value%20Measurement) This note details the fair value of available-for-sale securities, derivative contracts, and certain debt instruments Fair Value of Available-for-Sale Securities and Derivative Contracts (in thousands) | Category (Assets) | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :------------------------ | :------------------------- | :----------------------------- | | Money market funds | $517,669 | $1,253,970 | | Time deposits | $480,000 | $790,000 | | Foreign exchange forward contracts | $9,137 | $2,250 | | Interest rate contracts | $6 | $991 | | **Total Assets** | **$1,006,812** | **$2,047,211** | | | | | | Category (Liabilities) | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :------------------------ | :------------------------- | :----------------------------- | | Foreign exchange forward contracts | $2,801 | $10,198 | | Interest rate contracts | $48 | $0 | | **Total Liabilities** | **$2,849** | **$10,198** | - The estimated fair values of the 2026 Notes, 2030 Notes, and Secured Notes as of June 30, 2025, were **$1.0 billion**, **$1.1 billion**, and **$1.4 billion**, respectively. The Tranche B-2 Dollar Term Loans had an estimated fair value of **$1.9 billion**[60](index=60&type=chunk) [5. Derivative Instruments and Hedging Activities](index=22&type=section&id=5.%20Derivative%20Instruments%20and%20Hedging%20Activities) This note explains the company's use of foreign exchange forward contracts and interest rate swaps to manage market risks - The company uses foreign exchange forward contracts to manage foreign currency transaction risk and interest rate swap agreements to manage interest rate risk on variable rate debt, with all derivatives used for risk management, not speculation[61](index=61&type=chunk)[62](index=62&type=chunk) Foreign Exchange Forward Contracts Gain (Loss) (in thousands) | Period | 2025 (3 Months) | 2024 (3 Months) | 2025 (6 Months) | 2024 (6 Months) | | :-------------------- | :-------------- | :-------------- | :-------------- | :-------------- | | Gain (loss) recognized | $12,393 | $(825) | $21,000 | $(4,911) | - As of June 30, 2025, interest rate swap agreements had a notional amount of **$500.0 million**, fixing a portion of term loan interest at 3.9086% plus borrowing spread until April 2026[63](index=63&type=chunk) [6. Inventories](index=23&type=section&id=6.%20Inventories) This note provides a breakdown of inventory components and the impact of acquisition-related fair value adjustments Inventories (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Raw materials | $39,566 | $20,161 | | Work in process | $300,459 | $311,752 | | Finished goods | $164,964 | $148,532 | | **Total inventories** | **$504,989** | **$480,445** | - Total inventories increased by **$24.5 million** from December 31, 2024, to June 30, 2025. Inventories included **$138.0 million** and **$191.2 million** related to the GW acquisition's fair value step-up as of June 30, 2025, and December 31, 2024, respectively[66](index=66&type=chunk) [7. Goodwill and Intangible Assets](index=24&type=section&id=7.%20Goodwill%20and%20Intangible%20Assets) This note details the company's goodwill and finite-lived intangible assets, including foreign exchange changes and estimated amortization Goodwill (in thousands) | Metric | Amount | | :-------------------- | :------------ | | Balance at Dec 31, 2024 | $1,716,323 | | Foreign exchange | $127,651 | | **Balance at Jun 30, 2025** | **$1,843,974** | Intangible Assets, Net (in thousands) | Category (Net Book Value) | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Acquired developed technologies | $4,768,987 | $4,755,695 | | Manufacturing contracts | $0 | $0 | | Trademarks | $0 | $0 | | **Total finite-lived intangible assets** | **$4,768,987** | **$4,755,695** | - The increase in goodwill and intangible assets is primarily due to positive foreign currency translation adjustments, reflecting the strengthening of sterling against the U.S. dollar[67](index=67&type=chunk) Estimated Future Amortization Expense (in thousands) | Year Ending December 31, | Estimated Amortization Expense | | :----------------------- | :----------------------------- | | 2025 (remainder) | $340,354 | | 2026 | $678,197 | | 2027 | $669,802 | | 2028 | $646,640 | | 2029 | $644,906 | | Thereafter | $1,789,088 | | **Total** | **$4,768,987** | [8. Certain Balance Sheet Items](index=25&type=section&id=8.%20Certain%20Balance%20Sheet%20Items) This note provides detailed breakdowns of property, plant, equipment, and accrued liabilities Property, Plant and Equipment, Net (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Manufacturing equipment and machinery | $96,286 | $87,451 | | Land and buildings | $73,772 | $71,902 | | Computer software | $58,399 | $42,635 | | Leasehold improvements | $56,119 | $70,201 | | Construction-in-progress | $36,334 | $34,493 | | Computer equipment | $21,487 | $20,137 | | Furniture and fixtures | $8,902 | $8,551 | | Subtotal | $351,299 | $335,370 | | Less accumulated depreciation and amortization | $(166,324) | $(161,957) | | **Property, plant and equipment, net** | **$184,975** | **$173,413** | Accrued Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Rebates and other sales deductions | $429,142 | $342,717 | | Employee compensation and benefits | $103,074 | $153,133 | | Clinical trial accruals | $44,557 | $49,962 | | Inventory-related accruals | $41,670 | $25,509 | | Accrued interest | $40,703 | $41,626 | | Accrued royalties | $31,627 | $36,802 | | Sales return reserve | $29,816 | $26,428 | | Consulting and professional services | $24,425 | $26,221 | | Selling and marketing accruals | $23,265 | $26,981 | | Accrued development expenses | $20,613 | $23,099 | | Current portion of lease liabilities | $13,883 | $14,779 | | Accrued construction-in-progress | $7,705 | $10,061 | | Derivative instrument liabilities | $2,849 | $10,198 | | Accrued collaboration expenses | $2,339 | $18,005 | | Accrued milestones | $0 | $27,500 | | Other | $59,143 | $77,926 | | **Total accrued liabilities** | **$874,811** | **$910,947** | - Accrued liabilities decreased by **$36.1 million**, primarily due to decreases in employee compensation and benefits, accrued collaboration expenses, and accrued milestones, partially offset by an increase in rebates and other sales deductions[70](index=70&type=chunk) [9. Debt](index=26&type=section&id=9.%20Debt) This note details the company's debt instruments, including principal balances, maturities, and recent repayments Indebtedness (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | 2026 Notes, net | $997,478 | $996,253 | | 2030 Notes, net | $982,265 | $980,865 | | Secured Notes | $1,485,338 | $1,483,841 | | Term Loan | $1,899,013 | $2,647,681 | | **Total debt** | **$5,364,094** | **$6,108,640** | | Less current portion | $1,028,478 | $31,000 | | **Total long-term debt** | **$4,335,616** | **$6,077,640** | - Total debt decreased by **$744.5 million**, primarily due to a voluntary repayment of **$750.0 million** on the Tranche B-2 Dollar Term Loan in January 2025[71](index=71&type=chunk)[232](index=232&type=chunk) - The 2026 Notes are included in the current portion of long-term debt as they mature in June 2026, significantly increasing current liabilities[72](index=72&type=chunk) Scheduled Long-Term Debt Maturities (in thousands) | Year Ending December 31, | Scheduled Long-Term Debt Maturities | | :----------------------- | :---------------------------------- | | 2025 (remainder) | $15,500 | | 2026 | $1,031,000 | | 2027 | $31,000 | | 2028 | $1,848,500 | | 2029 | $1,500,000 | | Thereafter | $1,000,000 | | **Total** | **$5,426,000** | [10. Commitments and Contingencies](index=27&type=section&id=10.%20Commitments%20and%20Contingencies) This note outlines the company's legal proceedings, including antitrust, patent infringement, and acquisition-related litigation - The company is involved in various legal proceedings, including Xyrem antitrust litigation, patent infringement suits (Avadel, Xywav, Zepzelca, Defitelio), FDA litigation, a qui tam matter, and Chimerix acquisition litigation[81](index=81&type=chunk) - Jazz Pharmaceuticals Ireland Limited entered into a class settlement agreement for **$145 million** to resolve claims from indirect Xyrem purchasers in the antitrust litigation, which received preliminary court approval[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - In the Avadel patent infringement litigation, a jury found Jazz's asserted patents valid and awarded damages for infringement for Avadel's past sales of Lumryz. An injunction was granted, preventing Avadel from marketing Lumryz for new indications and imposing an ongoing royalty for narcolepsy sales[114](index=114&type=chunk) - The Chimerix acquisition litigation, alleging omitted material information and misrepresentations in tender offer documents, was dismissed after supplemental disclosures were filed[138](index=138&type=chunk)[139](index=139&type=chunk) [11. Shareholders' Equity](index=34&type=section&id=11.%20Shareholders'%20Equity) This note details changes in shareholders' equity, including share repurchase programs and accumulated other comprehensive loss - A new share repurchase program was authorized in July 2024 for **$500.0 million**. As of June 30, 2025, **$225.0 million** remained authorized[140](index=140&type=chunk) Share Repurchases (in millions) | Period | 2025 (3 Months) | 2024 (3 Months) | 2025 (6 Months) | 2024 (6 Months) | | :-------------------- | :-------------- | :-------------- | :-------------- | :-------------- | | Amount spent | $125.0 | $161.4 | $125.0 | $161.4 | | Shares repurchased (millions) | 1.1 | 1.5 | 1.1 | 1.5 | | Average price per share | $109.52 | $110.75 | $109.52 | $110.75 | Accumulated Other Comprehensive Loss (in thousands) | Category | December 31, 2024 | June 30, 2025 | | :------------------------ | :---------------- | :------------ | | Net Unrealized Gain (Loss) From Hedging Activities | $740 | $(47) | | Foreign Currency Translation Adjustments | $(948,407) | $(485,721) | | **Total Accumulated Other Comprehensive Loss** | **$(947,667)** | **$(485,768)** | - Accumulated other comprehensive loss decreased from **$(947.7) million** to **$(485.8) million**, primarily due to positive foreign currency translation adjustments from the strengthening of the sterling and euro against the U.S. dollar[141](index=141&type=chunk)[142](index=142&type=chunk) [12. Net Income (Loss) per Ordinary Share](index=35&type=section&id=12.%20Net%20Income%20(Loss)%20per%20Ordinary%20Share) This note presents basic and diluted net income or loss per ordinary share, along with weighted-average share counts Net Income (Loss) per Ordinary Share (in thousands, except per share amounts) | Metric | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :---------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net income (loss) | $(718,470) | $168,568 | $(811,011) | $153,950 | | Basic EPS | $(11.74) | $2.68 | $(13.28) | $2.45 | | Diluted EPS | $(11.74) | $2.49 | $(13.28) | $2.35 | | Weighted-average ordinary shares (basic) | 61,194 | 62,882 | 61,087 | 62,710 | | Weighted-average ordinary shares (diluted) | 61,194 | 69,625 | 61,087 | 69,684 | - The company reported a basic and diluted net loss per ordinary share of **$(11.74)** and **$(13.28)** for the three and six months ended June 30, 2025, respectively, a significant decline from positive EPS in the prior year periods[143](index=143&type=chunk) - The potential issue of ordinary shares from the 2026 Notes was anti-dilutive for the three and six months ended June 30, 2025, due to the company's election to fix the settlement method to a combination of cash and ordinary shares[144](index=144&type=chunk) [13. Revenues](index=36&type=section&id=13.%20Revenues) This note provides a detailed breakdown of total revenues by product and geographic source, highlighting growth drivers and declines Total Revenues by Product (in thousands) | Product/Category | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | YoY Change (%) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | YoY Change (%) | | :------------------------ | :-------------------------- | :-------------------------- | :------------- | :-------------------------- | :-------------------------- | :------------- | | Xywav | $415,321 | $368,472 | 13% | $760,125 | $683,772 | 11% | | Xyrem | $35,349 | $62,180 | (43)% | $72,590 | $126,412 | (43)% | | Epidiolex/Epidyolex | $251,730 | $247,102 | 2% | $469,467 | $445,818 | 5% | | Total Neuroscience | $707,015 | $684,137 | 3% | $1,312,204 | $1,265,120 | 4% | | Rylaze/Enrylaze | $100,659 | $107,829 | (7)% | $194,892 | $210,579 | (7)% | | Zepzelca | $74,541 | $81,047 | (8)% | $137,574 | $156,147 | (12)% | | Defitelio/defibrotide | $48,106 | $45,421 | 6% | $88,768 | $93,097 | (5)% | | Vyxeos | $44,851 | $43,012 | 4% | $74,395 | $75,035 | (1)% | | Ziihera | $5,991 | $0 | N/A | $7,966 | $0 | N/A | | Total Oncology | $274,148 | $277,309 | (1)% | $503,595 | $534,858 | (6)% | | Product sales, net | $985,571 | $964,144 | 2% | $1,824,989 | $1,806,246 | 1% | | High-sodium oxybate AG royalty revenue | $54,138 | $54,164 | 0% | $103,084 | $104,111 | (1)% | | Other royalty and contract revenues | $6,003 | $5,517 | 9% | $15,480 | $15,451 | 0% | | **Total revenues** | **$1,045,712** | **$1,023,825** | **2%** | **$1,943,553** | **$1,925,808** | **1%** | - Total revenues increased by **2%** and **1%** for the three and six months ended June 30, 2025, respectively, driven by Xywav and Epidiolex/Epidyolex sales growth, partially offset by declines in Xyrem, Rylaze/Enrylaze, and Zepzelca[147](index=147&type=chunk)[208](index=208&type=chunk) - Xywav sales increased due to higher sales volumes (**14%** in Q2, **14%** in H1) and a higher selling price, with patient adoption in narcolepsy and IH. Xyrem sales decreased significantly (**35%** in Q2, **38%** in H1) due to high-sodium oxybate competition and Xywav adoption[208](index=208&type=chunk) Total Revenues by Geographic Source (in thousands) | Geographic Source | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :---------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | United States | $936,283 | $924,592 | $1,734,797 | $1,732,806 | | Europe | $82,763 | $82,159 | $165,801 | $153,514 | | All other | $26,666 | $17,074 | $42,955 | $39,488 | | **Total revenues** | **$1,045,712** | **$1,023,825** | **$1,943,553** | **$1,925,808** | [14. Share-Based Compensation](index=37&type=section&id=14.%20Share-Based%20Compensation) This note details the company's share-based compensation expense across various functional categories Share-Based Compensation Expense (in thousands) | Category | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Selling, general and administrative | $40,999 | $35,137 | $82,673 | $75,350 | | Research and development | $20,651 | $17,272 | $41,581 | $36,103 | | Cost of product sales | $2,851 | $4,245 | $7,900 | $6,642 | | **Total share-based compensation expense, pre-tax** | **$64,501** | **$56,654** | **$132,154** | **$118,095** | | Income tax benefit from share-based compensation expense | $(12,259) | $(9,629) | $(21,793) | $(13,028) | | **Total share-based compensation expense, net of tax** | **$52,242** | **$47,025** | **$110,361** | **$105,067** | - Total pre-tax share-based compensation expense increased by **$7.8 million (14%)** for the three months and **$14.1 million (12%)** for the six months ended June 30, 2025, compared to the same periods in 2024[149](index=149&type=chunk) [15. Income Taxes](index=37&type=section&id=15.%20Income%20Taxes) This note explains the company's income tax benefit and the impact of recent tax law changes, including Pillar Two rules Income Tax Benefit (in millions) | Period | 2025 (3 Months) | 2024 (3 Months) | 2025 (6 Months) | 2024 (6 Months) | | :-------------------- | :-------------- | :-------------- | :-------------- | :-------------- | | Income tax benefit | $17.2 | $30.7 | $35.0 | $19.0 | - The income tax benefit for the six months ended June 30, 2025, was **$35.0 million**, an increase from **$19.0 million** in the prior year, primarily due to the tax impact of certain Xyrem antitrust litigation settlements[150](index=150&type=chunk)[222](index=222&type=chunk) - Ireland's Pillar Two global minimum tax rules, effective January 1, 2024, require a top-up tax for differences between the Pillar Two effective tax rate and the **15%** minimum rate, impacting the company's current tax[153](index=153&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of Jazz Pharmaceuticals' business, strategic growth drivers, and a detailed analysis of its financial performance for the three and six months ended June 30, 2025, compared to 2024. It covers revenue trends by product, operating expenses, and the company's liquidity and capital resources, highlighting key challenges and risks [Overview](index=39&type=section&id=Overview) This subsection introduces Jazz Pharmaceuticals' core business, strategic growth initiatives, and key marketed products - Jazz Pharmaceuticals is a global biopharmaceutical company focused on neuroscience and oncology, aiming to transform patient lives through innovative medicines for serious diseases with unmet needs[156](index=156&type=chunk) - The company's growth strategy centers on strong commercial execution, expanding and advancing its R&D pipeline, strategic corporate development (acquisitions/in-licensing), and unlocking value through indication expansion and global market entry[157](index=157&type=chunk)[158](index=158&type=chunk) - Key marketed products include Xywav (narcolepsy, IH), Epidiolex (LGS, DS, TSC), Rylaze (ALL, LBL), Zepzelca (SCLC), and Ziihera (HER2-positive BTC)[160](index=160&type=chunk) [Neuroscience](index=41&type=section&id=Neuroscience) This subsection highlights the company's leadership in oxybate therapy for sleep disorders and commercial performance of Xywav and Epidiolex - Jazz is a global leader in oxybate therapy for sleep disorders, with Xywav approved for narcolepsy (July 2020) and idiopathic hypersomnia (IH) in adults (August 2021). Xywav has **92% less sodium** than Xyrem and is the only approved oxybate without a high sodium warning[161](index=161&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - Xywav has Orphan Drug Exclusivity (ODE) for narcolepsy through January 2028 and for IH through August 2028[163](index=163&type=chunk)[164](index=164&type=chunk) - As of Q2 2025, approximately **15,225 patients** were taking Xywav (**10,600** for narcolepsy, **4,625** for IH), showing strong adoption, particularly a **40% increase** in IH patients year-over-year[166](index=166&type=chunk)[208](index=208&type=chunk) - Epidiolex (cannabidiol) was acquired in May 2021 and is approved for seizures associated with LGS, DS, and TSC in patients one year or older in the U.S. and other markets[167](index=167&type=chunk) [Oncology](index=42&type=section&id=Oncology) This subsection details the company's oncology product portfolio, including Rylaze, Zepzelca, Ziihera, Defitelio, and Vyxeos - Rylaze (asparaginase) was approved in June 2021 for ALL/LBL patients hypersensitive to E. coli-derived asparaginase, with an expanded dosing schedule approved in November 2022 and EC marketing authorization in September 2023[169](index=169&type=chunk) - Zepzelca (lurbinectedin) is approved for metastatic SCLC. Positive top-line Phase 3 results for Zepzelca in combination with Tecentriq as first-line maintenance therapy were announced in October 2024, with FDA granting Priority Review for the sNDA in June 2025 (PDUFA date: October 7, 2025)[170](index=170&type=chunk)[177](index=177&type=chunk) - Ziihera (zanidatamab-hrii) received accelerated FDA approval in November 2024 for previously treated, unresectable or metastatic HER2-positive BTC, and conditional EC marketing authorization in June 2025[172](index=172&type=chunk) - Defitelio is the only approved treatment for veno-occlusive disease (VOD) following HSCT. Vyxeos treats newly-diagnosed t-AML or AML-MRC in adults and pediatric patients[173](index=173&type=chunk)[174](index=174&type=chunk) [Research and Development Progress](index=42&type=section&id=Research%20and%20Development%20Progress) This subsection outlines the company's pipeline advancements in oncology and neuroscience, including clinical trials and acquisitions - Jazz is advancing its R&D pipeline in oncology and neuroscience, including clinical testing of new candidates and expanding indications for existing products, leveraging internal R&D and third-party collaborations[175](index=175&type=chunk) - In oncology, zanidatamab (Ziihera) is in multiple Phase 3 trials for HER2-expressing cancers (GEA, BTC, breast cancer). Zepzelca is in a Phase 3 trial for first-line SCLC maintenance therapy[176](index=176&type=chunk)[177](index=177&type=chunk) - The acquisition of Chimerix in April 2025 brought dordaviprone, a novel treatment for H3 K27M-mutant diffuse glioma, with an NDA under FDA Priority Review (PDUFA date: August 18, 2025)[181](index=181&type=chunk) - Neuroscience R&D includes a Phase 3 trial of Epidyolex in Japan (did not meet primary endpoint but showed numeric improvements), and early-stage development of JZP324 (extended-release low sodium oxybate) and JZP441 (orexin-2 receptor agonist for sleep disorders)[183](index=183&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk) [Challenges, Risks and Trends Related to Our Business](index=45&type=section&id=Challenges%2C%20Risks%20and%20Trends%20Related%20to%20Our%20Business) This subsection discusses significant risks including competition, pricing pressures, regulatory scrutiny, and global trade issues - Oxybate revenues face significant risks from competition (Avadel's Lumryz, AG versions of high-sodium oxybate) and pricing pressure from third-party payors, potentially impacting Xywav and Xyrem sales[188](index=188&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk)[192](index=192&type=chunk)[193](index=193&type=chunk) - Commercial success of Epidiolex/Epidyolex is dependent on market acceptance, adequate reimbursement, and future generic competition, with patent litigation settled for generic versions to launch in the late 2030s[194](index=194&type=chunk) - The company's growth strategy relies on successful R&D and strategic acquisitions/in-licensing, with failures in these areas potentially having a material adverse effect[197](index=197&type=chunk)[198](index=198&type=chunk) - Healthcare cost containment, drug pricing scrutiny (e.g., Inflation Reduction Act of 2022, 'most favored nation' pricing proposals), and government investigations into business practices (e.g., Xyrem antitrust litigation) pose significant financial and reputational risks[199](index=199&type=chunk)[201](index=201&type=chunk) - Global trade issues, including tariffs and export regulations, could increase costs, disrupt supply chains (especially for products manufactured in Ireland, UK, Italy, and APIs from China), and reduce product competitiveness[203](index=203&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) This subsection provides a detailed analysis of the company's financial performance, covering revenue, cost of sales, and operating expenses Key Financial Metrics (in thousands, except percentages) | Metric | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | YoY Change (%) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | YoY Change (%) | | :---------------------------- | :-------------------------- | :-------------------------- | :------------- | :-------------------------- | :-------------------------- | :------------- | | Product sales, net | $985,571 | $964,144 | 2% | $1,824,989 | $1,806,246 | 1% | | Royalties and contract revenues | $60,141 | $59,681 | 1% | $118,564 | $119,562 | (1)% | | Cost of product sales | $116,268 | $109,902 | 6% | $220,888 | $205,389 | 8% | | Selling, general and administrative | $358,399 | $338,523 | 6% | $872,412 | $690,235 | 26% | | Research and development | $189,972 | $220,734 | (14)% | $370,624 | $443,581 | (16)% | | Intangible asset amortization | $162,103 | $155,223 | 4% | $316,551 | $310,953 | 2% | | Acquired in-process research and development | $905,362 | $0 | N/A | $905,362 | $10,000 | N/A | | Interest expense, net | $47,363 | $62,023 | (24)% | $101,069 | $128,139 | (21)% | | Income tax benefit | $(17,170) | $(30,653) | (44)% | $(34,982) | $(18,984) | 84% | [Total Revenues](index=49&type=section&id=Total%20Revenues) This subsection analyzes the company's revenue performance, detailing contributions from key products and overall growth trends - Total revenues increased by **2%** to **$1.05 billion** for Q2 2025 and **1%** to **$1.94 billion** for H1 2025, primarily driven by Xywav and Epidiolex/Epidyolex sales growth[207](index=207&type=chunk)[208](index=208&type=chunk) - Xywav sales increased **13%** (Q2) and **11%** (H1) due to higher sales volumes and selling price, while Xyrem sales decreased **43%** (Q2 and H1) due to competition and Xywav adoption[207](index=207&type=chunk)[208](index=208&type=chunk) - Oncology product sales decreased by **1%** (Q2) and **6%** (H1), with Rylaze/Enrylaze down **7%** and Zepzelca down **8%** (Q2) and **12%** (H1) due to competition and treatment protocol changes. Ziihera contributed **$5.99 million** (Q2) and **$7.97 million** (H1) in its initial launch period[207](index=207&type=chunk)[209](index=209&type=chunk) [Cost of Product Sales](index=50&type=section&id=Cost%20of%20Product%20Sales) This subsection examines the cost of goods sold, including the impact of product mix and fair value step-up expenses - Cost of product sales increased by **6%** (Q2) and **8%** (H1) due to changes in product mix and higher fair value step-up expense (**$3.9 million** in Q2, **$4.8 million** in H1)[205](index=205&type=chunk)[213](index=213&type=chunk) - Gross margin as a percentage of net product sales was **88.2%** (Q2) and **87.9%** (H1) in 2025, compared to **88.6%** in 2024[213](index=213&type=chunk) [Selling, General and Administrative Expenses](index=50&type=section&id=Selling%20General%20and%20Administrative%20Expenses) This subsection analyzes trends in SG&A expenses, highlighting the impact of litigation settlements and commercial investments - SG&A expenses increased by **6%** (Q2) and **26%** (H1). The H1 increase was primarily due to **$172.0 million** in Xyrem antitrust litigation settlements[205](index=205&type=chunk)[214](index=214&type=chunk) - The company expects SG&A expenses to increase in 2025 due to litigation settlements, Chimerix acquisition costs, investment in the commercial portfolio (including Ziihera launch), and increased compensation[215](index=215&type=chunk) [Research and Development Expenses](index=50&type=section&id=Research%20and%20Development%20Expenses) This subsection details R&D expenditures, explaining changes due to clinical studies, personnel costs, and acquisition-related expenses - R&D expenses decreased by **14%** (Q2) and **16%** (H1), driven by reduced clinical studies and outside services costs related to zanidatamab and JZP385 (discontinued), partially offset by dordaviprone costs from the Chimerix acquisition[205](index=205&type=chunk)[217](index=217&type=chunk) Research and Development Expenses by Category (in thousands) | Category | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :---------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Clinical studies and outside services | $93,099 | $134,118 | $180,442 | $265,584 | | Personnel expenses | $75,439 | $68,305 | $149,798 | $141,301 | | Other | $21,434 | $18,311 | $40,384 | $36,696 | | **Total** | **$189,972** | **$220,734** | **$370,624** | **$443,581** | [Intangible Asset Amortization](index=51&type=section&id=Intangible%20Asset%20Amortization) This subsection discusses the amortization expense related to the company's intangible assets - Intangible asset amortization remained broadly consistent in the three and six months ended June 30, 2025, compared to the same periods in 2024[205](index=205&type=chunk)[219](index=219&type=chunk) [Acquired In-Process Research and Development](index=51&type=section&id=Acquired%20In-Process%20Research%20and%20Development) This subsection explains the expense recognized for in-process research and development acquired through business combinations - Acquired IPR&D expense of **$905.36 million** in Q2 and H1 2025 represents the value allocated to dordaviprone from the Chimerix Acquisition[205](index=205&type=chunk)[220](index=220&type=chunk) [Interest Expense, Net](index=51&type=section&id=Interest%20Expense%2C%20Net) This subsection analyzes the company's net interest expense, detailing the impact of debt repayments and new debt instruments - Net interest expense decreased by **24%** (Q2) and **21%** (H1), primarily due to lower interest expense on the Tranche B-2 Dollar Term Loans, partially offset by the inclusion of interest expense on the 2030 Notes[205](index=205&type=chunk)[221](index=221&type=chunk) [Income Tax Benefit](index=51&type=section&id=Income%20Tax%20Benefit) This subsection discusses the income tax benefit recognized, including the impact of litigation settlements - Income tax benefit was **$17.2 million** (Q2) and **$35.0 million** (H1) in 2025, compared to **$30.7 million** (Q2) and **$19.0 million** (H1) in 2024. The H1 2025 benefit was primarily due to the tax impact of Xyrem antitrust litigation settlements[205](index=205&type=chunk)[222](index=222&type=chunk) [Liquidity and Capital Resources](index=51&type=section&id=Liquidity%20and%20Capital%20Resources) This subsection assesses the company's financial flexibility, including cash position, debt levels, and ability to fund growth - As of June 30, 2025, the company had **$1.7 billion** in cash, cash equivalents, and investments, **$885.0 million** available under its revolving credit facility, and a long-term debt principal balance of **$5.4 billion**[223](index=223&type=chunk) - The company generated **$518.6 million** in cash flow from operations during the first six months of 2025 and expects to continue generating positive cash flows to fund operations and de-lever the balance sheet[223](index=223&type=chunk) - Voluntary repayments of **$750.0 million** were made on the Tranche B-2 Dollar Term Loans in January 2025, and the **$575.0 million** 2024 Notes were repaid in August 2024[224](index=224&type=chunk) - The company's substantial debt could impair flexibility and access to capital. Future growth plans may require additional capital through debt or equity financings, which could be impacted by economic conditions[225](index=225&type=chunk)[228](index=228&type=chunk) - A new **$500.0 million** share repurchase program was authorized in July 2024, with **$225.0 million** remaining as of June 30, 2025. **$125.0 million** was spent on repurchases in H1 2025[229](index=229&type=chunk) [Critical Accounting Estimates](index=53&type=section&id=Critical%20Accounting%20Estimates) This subsection highlights significant judgments and assumptions made in financial statements, which could materially impact reported results - The preparation of financial statements requires significant estimates and assumptions, particularly for revenue deductions, acquisition and valuation of intangibles, and income taxes. These estimates are subjective and complex, and actual results may differ[236](index=236&type=chunk) - Critical accounting policies and significant estimates have not substantially changed from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[237](index=237&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=54&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This subsection advises readers that the report contains forward-looking statements subject to risks and uncertainties - The report contains forward-looking statements subject to known and unknown risks and uncertainties that could cause actual results to differ materially from projections[238](index=238&type=chunk) - Key risks include inability to maintain oxybate revenues, competition from new products, regulatory restrictions on oxybate products, challenges in commercializing Epidiolex/Epidyolex, and difficulties in obtaining regulatory approvals for pipeline candidates[238](index=238&type=chunk)[243](index=243&type=chunk) - Other risks include competition, inadequate payor coverage/reimbursement, drug pricing scrutiny, supply chain disruptions, global trade issues, and challenges in integrating acquisitions like Chimerix[238](index=238&type=chunk)[239](index=239&type=chunk)[243](index=243&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=55&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there were no material changes to the company's market risk disclosures during the six months ended June 30, 2025, compared to those reported in the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to market risk disclosures were reported for the six months ended June 30, 2025[242](index=242&type=chunk) [Item 4. Controls and Procedures](index=56&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms that the company's disclosure controls and procedures were effective as of June 30, 2025, and that there were no material changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2025[244](index=244&type=chunk) - No changes to internal control over financial reporting materially affected, or are reasonably likely to materially affect, internal control over financial reporting during the quarter ended June 30, 2025[246](index=246&type=chunk) [PART II – OTHER INFORMATION](index=57&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section provides additional information on legal proceedings, risk factors, equity sales, and a list of exhibits [Item 1. Legal Proceedings](index=57&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the detailed information on legal proceedings from Note 10, Commitments and Contingencies—Legal Proceedings, found in Part I, Item 1 of this Quarterly Report on Form 10-Q - Legal proceedings information is incorporated by reference from Note 10, Commitments and Contingencies—Legal Proceedings[247](index=247&type=chunk) [Item 1A. Risk Factors](index=57&type=section&id=Item%201A.%20Risk%20Factors) This section supplements previously disclosed risk factors, detailing new or updated risks related to healthcare cost containment, global trade issues, the Chimerix acquisition, general acquisition and in-licensing activities, intellectual property protection, FDA disruptions, and changes in tax laws [Healthcare Cost Containment and Drug Pricing Scrutiny](index=57&type=section&id=Healthcare%20Cost%20Containment%20and%20Drug%20Pricing%20Scrutiny) This subsection details risks from legislative and regulatory efforts to control drug costs, including the IRA and new U.S. legislation - The U.S. healthcare industry faces fundamental changes due to increasing scrutiny of prescription drug costs, with legislative and regulatory proposals (e.g., IRA, state-level pricing controls) potentially impacting product profitability and reimbursement[249](index=249&type=chunk) - The Inflation Reduction Act of 2022 (IRA) introduces drug price negotiation for Medicare, penalties for price increases above inflation, and changes to Medicare Part D, which could negatively affect business and financial condition[249](index=249&type=chunk) - New legislation signed by President Trump on July 4, 2025, includes significant reforms to Medicaid, Medicare, and ACA tax credits, anticipated to decrease Medicaid spending and potentially reduce access and reimbursement for products[250](index=250&type=chunk) - European and international markets also impose cost-containing measures, including price limitations, reimbursement caps, and increased transparency on R&D costs, which could lead to downward price trends[255](index=255&type=chunk) [Global Trade Issues and Tariffs](index=58&type=section&id=Global%20Trade%20Issues%20and%20Tariffs) This subsection discusses potential adverse impacts of global trade restrictions, tariffs, and supply chain disruptions - Global trade restrictions, changes in trade policies, and export regulations, including tariffs, could increase costs, reduce product competitiveness, and adversely affect business operations[256](index=256&type=chunk)[257](index=257&type=chunk) - A Section 232 investigation initiated by the U.S. Secretary of Commerce is expected to result in new tariffs on pharmaceutical products, increasing manufacturing costs and supply chain complexity[259](index=259&type=chunk) - Relocating manufacturing in response to tariffs is complex, costly, and time-consuming, making it difficult to react quickly to a changing environment and potentially leading to product shortages[260](index=260&type=chunk) [Chimerix Acquisition Risks](index=59&type=section&id=Chimerix%20Acquisition%20Risks) This subsection outlines risks associated with the Chimerix acquisition, including regulatory approval, product success, and integration challenges - The success of the Chimerix acquisition depends on the ability to realize anticipated benefits from combining operations, which may not occur within the expected timeframe or cost[262](index=262&type=chunk) - Risks include dordaviprone's NDA not being approved by FDA in a timely manner, the product not being successful, or requiring greater resources than anticipated, and the assumption of unknown liabilities[262](index=262&type=chunk) [Acquisition and In-licensing Risks](index=60&type=section&id=Acquisition%20and%20In-licensing%20Risks) This subsection addresses challenges in identifying and integrating new acquisitions or in-licensed products - The company may be unable to identify or consummate suitable acquisition or in-licensing opportunities, impairing business growth, especially given competition from companies with greater resources[263](index=263&type=chunk) - Integrating acquired products or candidates poses risks, including unexpected difficulties, substantial costs, failure to retain key personnel, and diversion of management attention[264](index=264&type=chunk)[266](index=266&type=chunk) - Acquired products may not produce anticipated revenues, earnings, or regulatory approvals, as seen with the **$133.6 million** asset impairment charge from the discontinued nabiximols program acquired in the GW acquisition[265](index=265&type=chunk) [Intellectual Property Protection Risks](index=61&type=section&id=Intellectual%20Property%20Protection%20Risks) This subsection details challenges in obtaining, maintaining, and defending intellectual property, including patent litigation and generic competition - Commercial success depends on obtaining, maintaining, and defending intellectual property, but legal means offer limited protection, and patents can be challenged, invalidated, or designed around by competitors[267](index=267&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk) - Lupin and Teva have filed ANDAs for generic Xywav, and Zepzelca ANDA filers have also submitted applications, leading to patent infringement lawsuits and potential generic competition[270](index=270&type=chunk)[278](index=278&type=chunk) - Avadel's Lumryz was found to infringe Jazz's oxybate patents, resulting in damages and an injunction, but Avadel has filed its own patent infringement suits against Jazz's Xywav sales[277](index=277&type=chunk)[118](index=118&type=chunk) - Reliance on trade secret protection for products like Defitelio carries risks, as trade secrets can be independently developed or unintentionally/willfully disclosed by employees or partners[279](index=279&type=chunk) [FDA Disruptions](index=62&type=section&id=FDA%20Disruptions) This subsection highlights risks from potential disruptions at the FDA, which could delay regulatory approvals and impact product launches - Disruptions at the FDA, including workforce reductions or inadequate funding, could delay product reviews, approvals, and other regulatory actions, negatively impacting the business[280](index=280&type=chunk) - Delays in obtaining regulatory approval for dordaviprone, which has a PDUFA action date of August 18, 2025, could increase costs and adversely affect the anticipated benefits of the Chimerix acquisition[281](index=281&type=chunk) [Changes to Tax Laws](index=63&type=section&id=Changes%20to%20Tax%20Laws) This subsection discusses the potential impact of evolving tax laws, including global minimum tax rules and U.S. legislation - Changes in tax laws related to multinational corporations, such as the OECD's Pillar Two global minimum tax (**15%** effective January 1, 2024) and new provisions in the U.S. Inflation Reduction Act (**15%** corporate alternative minimum tax, **1%** excise tax on share repurchases), could adversely affect the company's effective tax rate, tax liabilities, and cash taxes[282](index=282&type=chunk)[283](index=283&type=chunk)[284](index=284&type=chunk) - Recent U.S. legislation (July 4, 2025) extended certain 2017 Tax Cuts and Jobs Act provisions and amended foreign-derived intangible income rules, increasing the effective tax rate for such income and excluding certain R&D and interest expenses from deductions[285](index=285&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=64&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the company's share repurchase activities under its publicly announced programs, including the number of shares purchased, average price paid, and the remaining authorized amount [Issuer Purchases of Equity Securities](index=64&type=section&id=Issuer%20Purchases%20of%20Equity%20Securities) This subsection provides a table and details on the company's share repurchase activities during the reporting period Issuer Purchases of Equity Securities (Three Months Ended June 30, 2025) | Period | Total Number of Shares Purchased | Average Price Paid per Share | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs | Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs | | :---------------------- | :------------------------------- | :--------------------------- | :----------------------------------------------------------------------------- | :--------------------------------------------------------------------------------------------------------- | | April 1 - April 30, 2025 | 0 | $0 | 0 | $349,999,951 | | May 1 - May 31, 2025 | 1,141,570 | $109.52 | 1,141,570 | $224,999,972 | | June 1 - June 30, 2025 | 0 | $0 | 0 | $224,999,972 | | **Total** | **1,141,570** | **$109.52** | **1,141,570** | | - During the three months ended June 30, 2025, the company repurchased **1.14 million** ordinary shares for a total of **$125.0 million** under the New Repurchase Program, at an average price of **$109.52** per share[286](index=286&type=chunk) - As of June 30, 2025, **$225.0 million** remained authorized for repurchases under the New Repurchase Program, which has no expiration date[286](index=286&type=chunk) [Item 6. Exhibits](index=65&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including transaction agreements, organizational documents, license agreements, and certifications - Exhibits include the Transaction Agreement for the GW Pharmaceuticals acquisition, the Agreement and Plan of Merger for the Chimerix acquisition, Amended and Restated Memorandum and Articles of Association, License and Option Agreements, and certifications from the CEO and CFO[287](index=287&type=chunk) [SIGNATURES](index=66&type=section&id=SIGNATURES) This section contains the signatures of the principal executive officer, principal financial officer, and principal accounting officer, certifying the filing of the Quarterly Report on Form 10-Q - The report is signed by Bruce C. Cozadd (Chairman and CEO), Philip L. Johnson (EVP and CFO), and Patricia Carr (SVP, Chief Accounting Officer) on August 6, 2025[292](index=292&type=chunk)

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]

Jazz Pharmaceuticals (JAZZ) came out with a quarterly loss of $8.25 per share versus the Zacks Consensus Estimate of a loss of $6.12. This compares to earnings of $5.3 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -34.80%. A quarter ago, it was expected that this drugmaker would post earnings of $4.51 per share when it actually produced earnings of $1.68, delivering a surprise of -62.75%. Over the last four quarters, the co ...

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 ...

Exhibit 99.1 Jazz Pharmaceuticals Announces Second Quarter 2025 Financial Results and Updates 2025 Financial Guidance – Renee Gala named as President and CEO, effective August 11 – – Total revenues of $1.05 billion in 2Q25 – – Xywav revenues grew 13% year-over-year, with robust net patient adds of 625 quarter-over-quarter – – Zepzelca granted Priority Review in 1L ES-SCLC – ® ® DUBLIN, August 5, 2025 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the second quarter of 2025 ...