Core Insights - Jazz Pharmaceuticals reported a second-quarter 2025 adjusted loss of $8.25 per share, which was wider than the Zacks Consensus Estimate of a loss of $6.12, primarily due to a one-time charge from the acquisition of Chimerix that impacted earnings by $14.75 per share [1][10] Financial Performance - Total revenues increased by 2% year over year to $1.05 billion, aligning with the Zacks Consensus Estimate [2] - Net product sales rose 2% year over year to $986 million, missing the Zacks Consensus Estimate of $999 million and the model estimate of $1 billion [3] - Royalty revenues from high-sodium oxybate authorized generic remained flat year over year at $54 million, exceeding the Zacks Consensus Estimate of $49 million and the model estimate of $43 million [3] - Other royalties and contract revenues increased by 9% year over year to $6 million [4] Neuroscience Segment - Sales of neuroscience products grew by 3% year over year to $707 million [5] - Combined net product sales for the oxybate business (Xyrem + Xywav) rose about 5% to $451 million, surpassing the Zacks Consensus Estimate of $440 million [5] - Xywav sales reached $415 million, up 13%, attributed to strong uptake in narcolepsy and idiopathic hypersomnia indications [6] - Sales of the epilepsy drug Epidiolex/Epidyolex increased by 2% to nearly $252 million, but fell short of the Zacks Consensus Estimate of $271 million [7] Oncology Segment - Oncology product sales decreased by 1% to $274 million [8] - Rylaze/Enrylaze sales were $101 million, down 7% year over year, missing both the Zacks Consensus Estimate and model estimates [9] - Zepzelca sales were $75 million, down 8% year over year, due to increased competition and treatment protocol updates [11] Operating Costs - Adjusted selling, general and administrative expenses rose by 2% year over year to $310 million [13] - Adjusted research and development expenses decreased by 18% to $167 million [13] Guidance and Market Reaction - The company lowered its 2025 revenue guidance to $4.15-$4.30 billion, reflecting a $100 million cut at the upper end [10][14] - Adjusted earnings per share outlook was raised to $4.80-$5.60, up from the previous range of $4.00-$5.60 [10][18] - Shares of Jazz fell more than 7% in after-market trading following the earnings guidance and wider-than-expected loss [15]

[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]

Company Performance - Jazz Pharmaceuticals reported a quarterly loss of $8.25 per share, which was worse than the Zacks Consensus Estimate of a loss of $6.12, and a significant decline from earnings of $5.3 per share a year ago, indicating an earnings surprise of -34.80% [1] - The company posted revenues of $1.05 billion for the quarter ended June 2025, missing the Zacks Consensus Estimate by 0.26%, but showing a slight increase from year-ago revenues of $1.02 billion [2] - Over the last four quarters, Jazz has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance and Outlook - Jazz shares have declined approximately 5.7% since the beginning of the year, contrasting with the S&P 500's gain of 7.6% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is $5.08 on revenues of $1.11 billion, and for the current fiscal year, it is $4.93 on revenues of $4.24 billion [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Jazz belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, indicating potential challenges for stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors or through tools like the Zacks Rank [5][6]

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]

Financial Performance - Total revenues reached $761 million in 2Q25, a 2% year-over-year increase[93] - Neuroscience revenues accounted for 43% of the total, amounting to $335 million in 2Q25[98] - Oncology revenues totaled $274 million in 2Q25[100] - The company updated its full-year 2025 revenue guidance to a range of $415 billion to $430 billion[30, 36] - The company projects non-GAAP adjusted net income to be in the range of $300 million to $350 million, with adjusted EPS between $480 and $560[36] Product Performance - Xywav revenues were $415 million in 2Q25, representing a 13% year-over-year growth[100] - Epidiolex revenues reached $252 million in 2Q25, a 2% year-over-year increase[100] - Rylaze revenues were $101 million in 2Q25, a 7% year-over-year decrease[53] - Zepzelca revenues were $75 million in 2Q25, an 8% year-over-year decrease[59] Pipeline and Corporate Development - The company closed the Chimerix Acquisition for a total consideration of $944 million[32, 33] - The acquisition of Chimerix included an acquired IPR&D expense of $9054 million related to dordaviprone[23, 94, 113] - A PDUFA target action date of October 7, 2025, was set for Zepzelca as maintenance therapy in 1L ES-SCLC[35, 61, 62]

[Executive Summary](index=1&type=section&id=Executive%20Summary) Jazz Pharmaceuticals reported strong Q2 2025 financial performance, leadership transition, and updated 2025 financial guidance [Second Quarter 2025 Financial Performance Overview](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Performance%20Overview) Jazz Pharmaceuticals reported total revenues of $1.05 billion in Q2 2025, with Xywav revenues growing 13% year-over-year and robust net patient adds. The company also announced key regulatory milestones, including Priority Review for Zepzelca in 1L ES-SCLC - Total revenues reached **$1.05 billion** in Q2 2025[1](index=1&type=chunk) - Xywav revenues increased by **13% year-over-year**, with approximately **625 net patient adds** quarter-over-quarter[1](index=1&type=chunk) - Zepzelca was granted Priority Review by the U.S. FDA for 1L maintenance treatment of ES-SCLC[1](index=1&type=chunk)[4](index=4&type=chunk) [Leadership Transition](index=1&type=section&id=Leadership%20Transition) Renee Gala has been appointed as President and CEO, effective August 11, succeeding Bruce Cozadd, who expressed confidence in her ability to drive long-term growth - Renee Gala named President and CEO, effective August 11[1](index=1&type=chunk)[2](index=2&type=chunk) [Updated 2025 Financial Guidance](index=1&type=section&id=Updated%202025%20Financial%20Guidance) Jazz Pharmaceuticals updated its 2025 financial guidance, narrowing the total revenue range to $4.15 - $4.30 billion, representing 4% growth at the midpoint. The lower end of net (loss)/income and (loss)/earnings per share ranges were raised due to reductions in SG&A and R&D expenses and an improved effective tax rate Updated 2025 Total Revenue Guidance | Metric | Updated Guidance (August 5, 2025) | | :----- | :-------------------------------- | | Total Revenues | $4.15 - $4.30 billion | - Lower end of net (loss)/income and (loss)/earnings per share ranges raised due to reductions in SG&A and R&D and improvement in effective tax rate ranges[4](index=4&type=chunk) [Business Updates](index=1&type=section&id=Business%20Updates) The company provided updates on its commercial products, corporate development, pipeline highlights, and share repurchases [Commercial Updates](index=1&type=section&id=Commercial%20Updates) The company provided updates on its key commercial products across Neuroscience and Oncology portfolios, highlighting strong performance from Xywav and Epidiolex/Epidyolex, while Rylaze/Enrylaze and Zepzelca experienced sales decreases due to market dynamics and competition [Neuroscience Portfolio Performance](index=1&type=section&id=Neuroscience%20Portfolio%20Performance) Xywav demonstrated strong growth with a 13% increase in net product sales and significant patient additions, reinforcing its position as a leading treatment for narcolepsy and IH. Epidiolex/Epidyolex also saw a 2% sales increase and is on track to achieve blockbuster status in 2025, while Xyrem sales declined Xywav Performance (2Q25 vs 2Q24) | Metric | 2Q25 | 2Q24 | Change (YoY) | | :----- | :--- | :--- | :----------- | | Net Product Sales | $415.3 million | $368.5 million | +13% | | Active Patients (exiting 2Q25) | ~15,225 | N/A | N/A | | Net Patient Adds (2Q25) | ~625 | N/A | N/A | | IH Net Patient Adds (2Q25) | 400 | N/A | N/A | - Xywav is the only low-sodium oxybate and the **1 branded treatment** for narcolepsy and the only FDA-approved therapy for IH, described by the FDA as clinically superior to Xyrem by means of greater safety[5](index=5&type=chunk) Epidiolex/Epidyolex and Xyrem Sales (2Q25 vs 2Q24) | Product | 2Q25 Net Product Sales | 2Q24 Net Product Sales | Change (YoY) | | :------ | :--------------------- | :--------------------- | :----------- | | Epidiolex/Epidyolex | $251.7 million | $247.1 million | +2% | | Xyrem | $35.3 million | $62.2 million | -43.2% | - Company remains confident in achieving **blockbuster status for Epidiolex/Epidyolex in 2025**[7](index=7&type=chunk) [Oncology Portfolio Performance](index=2&type=section&id=Oncology%20Portfolio%20Performance) Oncology net product sales decreased by 1% in Q2 2025, primarily due to lower sales of Rylaze/Enrylaze and Zepzelca, partially offset by the launch of Ziihera. Zepzelca received U.S. FDA Priority Review for 1L ES-SCLC maintenance treatment, indicating potential for future growth Oncology Product Sales (2Q25 vs 2Q24) | Product | 2Q25 Net Product Sales | 2Q24 Net Product Sales | Change (YoY) | | :------ | :--------------------- | :--------------------- | :----------- | | Rylaze/Enrylaze | $100.7 million | $107.8 million | -7% | | Zepzelca | $74.5 million | $81.0 million | -8% | | Ziihera | $6.0 million | — | N/A (launched Dec 2024) | - Decrease in Rylaze/Enrylaze sales attributed to pediatric asparaginase use remaining below pre-protocol implementation levels[7](index=7&type=chunk) - Zepzelca sales decrease driven by increased competition in 2L SCLC and treatment protocol updates delaying progression of 1L limited-stage SCLC patients to the 2L setting[7](index=7&type=chunk) - Zepzelca and atezolizumab combination granted U.S. FDA Priority Review for 1L maintenance treatment of ES-SCLC with a PDUFA action date of **October 7, 2025**[4](index=4&type=chunk)[7](index=7&type=chunk) - Ziihera received conditional marketing authorization by the European Commission for 2L BTC[4](index=4&type=chunk)[7](index=7&type=chunk) [Corporate Development](index=3&type=section&id=Corporate%20Development) Jazz Pharmaceuticals completed the acquisition of Chimerix in April 2025, adding dordaviprone, a novel treatment for H3 K27M-mutant diffuse glioma, to its late-stage pipeline - Acquisition of Chimerix, Inc. completed in April 2025, adding dordaviprone to the late-stage pipeline[8](index=8&type=chunk) - Dordaviprone is a novel first-in-class small molecule treatment for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor[8](index=8&type=chunk) [Key Pipeline Highlights](index=3&type=section&id=Key%20Pipeline%20Highlights) The company's pipeline is advancing with key milestones expected for zanidatamab, including top-line Phase 3 data in 1L GEA in Q4 2025 and initiation of a new Phase 2 trial in breast cancer. Dordaviprone received FDA Priority Review for accelerated approval in recurrent H3 K27M-mutant diffuse glioma, with a PDUFA date in August 2025 - Top-line PFS data from the pivotal HERIZON-GEA-01 trial for zanidatamab in 1L GEA is expected in **4Q25**[4](index=4&type=chunk)[12](index=12&type=chunk) - New data for zanidatamab in combination with chemotherapy for 1L HER2-positive metastatic GEA showed a median overall survival of **36.5 months** and **15.2 months** median progression-free survival[12](index=12&type=chunk) - Phase 2 EmpowHER-BC-208 trial initiated in August 2025 to evaluate zanidatamab in HER2-positive neoadjuvant and adjuvant breast cancer[12](index=12&type=chunk) - New Drug Application for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma accepted and granted Priority Review by FDA, with a PDUFA action date of **August 18, 2025**[12](index=12&type=chunk) - The ongoing 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) [Share Repurchases](index=3&type=section&id=Share%20Repurchases) The company resumed its share repurchase program in Q2 2025, repurchasing approximately $125 million of ordinary shares. As of June 30, 2025, $225 million remained authorized under the program - Approximately **$125 million** of ordinary shares repurchased in Q2 2025[10](index=10&type=chunk) - As of June 30, 2025, **$225 million** remained outstanding under the **$500 million** share repurchase authorization[10](index=10&type=chunk) [Financial Performance (GAAP & Non-GAAP)](index=3&type=section&id=Financial%20Performance%20%28GAAP%20%26%20Non-GAAP%29) This section details Jazz Pharmaceuticals' GAAP and non-GAAP financial results, including revenues, operating expenses, and balance sheet items [Overall Financial Highlights](index=3&type=section&id=Overall%20Financial%20Highlights) Jazz Pharmaceuticals reported a GAAP net loss of $(718.5) million and a non-GAAP adjusted net loss of $(504.8) million for Q2 2025, primarily driven by a significant acquired IPR&D expense of $905.4 million related to the Chimerix acquisition. Total revenues increased by 2% year-over-year Key Financial Highlights (Three Months Ended June 30) | Metric | 2025 | 2024 | | :-------------------------------- | :----------- | :----------- | | Total revenues | $1,045,712 | $1,023,825 | | GAAP net income (loss) | $(718,470) | $168,568 | | Non-GAAP adjusted net income (loss) | $(504,849) | $360,656 | | GAAP earnings (loss) per share | $(11.74) | $2.49 | | Non-GAAP adjusted earnings (loss) per share | $(8.25) | $5.25 | - GAAP and non-GAAP adjusted net loss in 2Q25 included acquired in-process research and development (IPR&D) expense of **$905.4 million**, representing the value allocated to dordaviprone in the Chimerix Acquisition, impacting results by **$14.78 per share (GAAP)** and **$14.75 per share (non-GAAP adjusted)**[14](index=14&type=chunk) - Total revenues increased **2%** in 2Q25 compared to the same period in 2024[15](index=15&type=chunk) [Total Revenues Analysis](index=4&type=section&id=Total%20Revenues%20Analysis) Total revenues for Q2 2025 increased by 2% to $1,045.7 million. Neuroscience revenue grew by 3% driven by Xywav and Epidiolex/Epidyolex, while Oncology net product sales decreased by 1% due to lower Rylaze/Enrylaze and Zepzelca sales, partially offset by Ziihera Total Revenues (2Q25 vs 2Q24) | Category | 2Q25 (in thousands) | 2Q24 (in thousands) | Change (YoY) | | :------- | :------------------ | :------------------ | :----------- | | Product sales, net | $985,571 | $964,144 | +2.2% | | Royalties and contract revenues | $60,141 | $59,681 | +0.8% | | **Total revenues** | **$1,045,712** | **$1,023,825** | **+2.1%** | [Neuroscience Revenue](index=4&type=section&id=Neuroscience%20Revenue) Total Neuroscience revenue, including high-sodium oxybate AG royalty revenue, increased by 3% to $761.2 million in Q2 2025, primarily due to higher Xywav and Epidiolex/Epidyolex net product sales, despite a decrease in Xyrem sales Neuroscience Product Sales (2Q25 vs 2Q24) | Product | 2Q25 (in thousands) | 2Q24 (in thousands) | Change (YoY) | | :---------------------- | :------------------ | :------------------ | :----------- | | Xywav | $415,321 | $368,472 | +12.7% | | Xyrem | $35,349 | $62,180 | -43.2% | | Epidiolex/Epidyolex | $251,730 | $247,102 | +1.9% | | Sativex | $4,615 | $6,383 | -27.6% | | Total Neuroscience | $707,015 | $684,137 | +3.3% | | High-sodium oxybate AG royalty revenue | $54,138 | $54,164 | -0.05% | | **Total Neuroscience Revenue** | **$761,153** | **$738,301** | **+3.1%** | [Oncology Revenue](index=4&type=section&id=Oncology%20Revenue) Oncology net product sales decreased by 1% to $274.1 million in Q2 2025. This decline was mainly due to lower sales of Rylaze/Enrylaze and Zepzelca, partially offset by the contribution from Ziihera, which launched in December 2024 Oncology Product Sales (2Q25 vs 2Q24) | Product | 2Q25 (in thousands) | 2Q24 (in thousands) | Change (YoY) | | :---------------- | :------------------ | :------------------ | :----------- | | Rylaze/Enrylaze | $100,659 | $107,829 | -6.7% | | Zepzelca | $74,541 | $81,047 | -8.0% | | Defitelio/defibrotide | $48,106 | $45,421 | +5.9% | | Vyxeos | $44,851 | $43,012 | +4.3% | | Ziihera | $5,991 | — | N/A | | **Total Oncology** | **$274,148** | **$277,309** | **-1.1%** | [Operating Expenses and Effective Tax Rate](index=5&type=section&id=Operating%20Expenses%20and%20Effective%20Tax%20Rate) Operating expenses saw notable changes in Q2 2025. GAAP and non-GAAP cost of product sales increased due to product mix. SG&A expenses rose due to compensation-related expenses and higher headcount. R&D expenses decreased primarily from lower clinical study costs for zanidatamab and JZP385, partially offset by dordaviprone costs. Acquired IPR&D significantly increased due to the Chimerix acquisition GAAP Operating Expenses (Three Months Ended June 30) | Metric | 2025 (in thousands) | 2024 (in thousands) | % of Total Revenues (2025) | % of Total Revenues (2024) | | :-------------------------- | :------------------ | :------------------ | :------------------------- | :------------------------- | | Cost of product sales | $116,268 | $109,902 | 11.1% | 10.7% | | Gross margin | 88.2% | 88.6% | N/A | N/A | | Selling, general and administrative | $358,399 | $338,523 | 34.3% | 33.1% | | Research and development | $189,972 | $220,734 | 18.2% | 21.6% | | Acquired IPR&D | $905,362 | — | 86.6% | 0.0% | | Income tax benefit | $(17,170) | $(30,653) | N/A | N/A | | Effective tax rate | 2.3% | (22.2)% | N/A | N/A | Non-GAAP Adjusted Operating Expenses (Three Months Ended June 30) | Metric | 2025 (in thousands) | 2024 (in thousands) | % of Total Revenues (2025) | % of Total Revenues (2024) | | :-------------------------- | :------------------ | :------------------ | :------------------------- | :------------------------- | | Cost of product sales | $76,308 | $72,413 | 7.3% | 7.1% | | Gross margin | 92.3% | 92.5% | N/A | N/A | | Selling, general and administrative | $310,322 | $303,386 | 29.7% | 29.6% | | Research and development | $167,031 | $203,463 | 16.0% | 19.9% | | Acquired IPR&D | $905,362 | — | 86.6% | 0.0% | | Income tax expense | $42,290 | $22,379 | N/A | N/A | | Effective tax rate | (9.1)% | 5.8% | N/A | N/A | - R&D expenses decreased primarily due to lower clinical study costs for zanidatamab and JZP385, partially offset by costs related to dordaviprone following the Chimerix Acquisition[20](index=20&type=chunk) - Acquired IPR&D in 2Q25 represents the **$905.4 million** value allocated to dordaviprone in the Chimerix Acquisition[21](index=21&type=chunk) [Cash Flow and Balance Sheet](index=6&type=section&id=Cash%20Flow%20and%20Balance%20Sheet) As of June 30, 2025, Jazz Pharmaceuticals held $1.7 billion in cash, cash equivalents, and investments, with $5.4 billion in long-term debt. The company generated $518.6 million in cash from operations for the first six months of 2025, while the Chimerix acquisition was funded with $944.2 million in cash Cash, Investments, and Debt (As of June 30, 2025) | Metric | Amount | | :-------------------------- | :------------- | | Cash, cash equivalents and investments | $1.7 billion | | Outstanding principal balance of long-term debt | $5.4 billion | | Undrawn borrowing capacity (revolving credit facility) | $885.0 million | - Generated **$518.6 million** of cash from operations for the six months ended June 30, 2025[22](index=22&type=chunk) - The Chimerix acquisition in April 2025 for **$944.2 million** was funded with cash and cash equivalents[22](index=22&type=chunk) [2025 Financial Guidance](index=6&type=section&id=2025%20Financial%20Guidance) This section outlines Jazz Pharmaceuticals' updated 2025 financial guidance, including revenue, GAAP, and non-GAAP projections [Updated Guidance Summary](index=6&type=section&id=Updated%20Guidance%20Summary) Jazz Pharmaceuticals updated its full-year 2025 financial guidance, revising the total revenue range and adjusting various GAAP and non-GAAP metrics. The changes reflect reductions in SG&A and R&D expenses and an improved effective tax rate Updated 2025 Total Revenue Guidance | Metric | August 5, 2025 Guidance | May 6, 2025 Guidance | | :----- | :---------------------- | :------------------- | | Total Revenues | $4,150 - $4,300 million | $4,150 - $4,400 million | [GAAP Guidance](index=6&type=section&id=GAAP%20Guidance) The GAAP guidance for 2025 shows a narrowed net loss range and improved net loss per diluted share, driven by lower projected SG&A and R&D expenses and a higher effective tax rate. Acquired IPR&D is set at $905 million 2025 GAAP Financial Guidance (Updated August 5, 2025) | Metric | August 5, 2025 Guidance | | :------------------------------------------ | :---------------------- | | Gross margin % | 88% | | SG&A expenses | $1,620 - $1,693 million | | R&D expenses | $805 - $865 million | | Acquired IPR&D | $905 million | | Effective tax rate | 4% - 16% | | Net loss | $(565) - $(450) million | | Net loss per diluted share | $(9.25) - $(7.50) | | Weighted-average ordinary shares (diluted) | 61 - 62 million | [Non-GAAP Guidance](index=6&type=section&id=Non-GAAP%20Guidance) The non-GAAP adjusted guidance for 2025 projects a higher net income range and improved diluted EPS compared to previous guidance, reflecting reduced SG&A and R&D expenses and a revised effective tax rate. Acquired IPR&D remains a significant factor 2025 Non-GAAP Financial Guidance (Updated August 5, 2025) | Metric | August 5, 2025 Guidance | | :------------------------------------------ | :---------------------- | | Gross margin % | 92% | | SG&A expenses | $1,450 - $1,500 million | | R&D expenses | $730 - $780 million | | Acquired IPR&D | $905 million | | Effective tax rate | 27% - 37% | | Net income | $300 - $350 million | | Net income per diluted share | $4.80 - $5.60 | | Weighted-average ordinary shares (diluted) | 62 - 63 million | - Projected GAAP net loss and non-GAAP adjusted net income include an acquired IPR&D expense of **$905.4 million** and Xyrem antitrust litigation settlements of **$172.0 million**, impacting results by **$1.1 billion (net of tax)** or **$16.96 per share (GAAP)** and **$16.83 per share (non-GAAP adjusted)**[25](index=25&type=chunk)[27](index=27&type=chunk) [Additional Information](index=7&type=section&id=Additional%20Information) This section provides details on the conference call, company overview, non-GAAP measures, and 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 August 5, 2025, to discuss Q2 2025 results and provide a business and financial update. Registration and webcast replay details were provided - Investor conference call and live audio webcast held on **August 5, 2025, at 4:30 p.m. EDT**[28](index=28&type=chunk) - Registration and webcast replay available via the Investors section of the Jazz Pharmaceuticals website[29](index=29&type=chunk) [About Jazz Pharmaceuticals](index=7&type=section&id=About%20Jazz%20Pharmaceuticals) Jazz Pharmaceuticals plc is a global biopharmaceutical company focused on developing life-changing medicines for serious diseases, with a diverse portfolio in sleep disorders, epilepsy, and oncology. The company emphasizes 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[30](index=30&type=chunk) - Diverse portfolio includes marketed medicines for sleep disorders, epilepsy, and a growing portfolio of cancer treatments[30](index=30&type=chunk) - Headquartered in Dublin, Ireland, with R&D labs, manufacturing facilities, and employees worldwide[30](index=30&type=chunk) [Non-GAAP Financial Measures Explanation](index=7&type=section&id=Non-GAAP%20Financial%20Measures%20Explanation) The company uses non-GAAP adjusted financial measures to supplement GAAP results, believing they provide useful supplementary information for investors and analysts to compare performance, track guidance, and identify operating trends. These measures exclude certain items like intangible asset amortization, share-based compensation, and acquisition accounting inventory fair value step-up, and are regularly used internally for management decisions - Non-GAAP financial measures are used to supplement GAAP results, providing additional analysis for investors and analysts[31](index=31&type=chunk)[32](index=32&type=chunk) - Non-GAAP adjustments exclude items such as intangible asset amortization, share-based compensation expense, acquisition accounting inventory fair value step-up, and integration related expenses[31](index=31&type=chunk)[32](index=32&type=chunk) - Commencing with Q1 2025, the company no longer includes an adjustment for non-cash interest expense in non-GAAP measures, with 2024 periods updated for comparability[33](index=33&type=chunk) [Caution Concerning Forward-Looking Statements](index=8&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. These statements are based on current plans and involve significant risks and uncertainties that could cause actual results to differ materially, including market competition, regulatory approvals, clinical trial success, and integration of acquisitions - The press release contains forward-looking statements regarding growth prospects, financial results, pipeline catalysts, regulatory approvals, and commercialization strategies[34](index=34&type=chunk) - Actual results could differ materially due to significant risks and uncertainties, including maintaining sales, new product competition, regulatory approval processes, clinical trial success, and integration of acquired businesses like Chimerix[35](index=35&type=chunk)[36](index=36&type=chunk) - Risks also include global economic disruptions, geopolitical events, macroeconomic conditions, and intellectual property protection[36](index=36&type=chunk) [Condensed Consolidated Financial Statements](index=10&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents Jazz Pharmaceuticals' unaudited condensed consolidated financial statements, including income, balance sheets, and cash flows [Condensed Consolidated Statements of Income (Loss)](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income%20%28Loss%29) The condensed consolidated statements of income (loss) show a GAAP net loss of $(718.5) million for Q2 2025, compared to a net income of $168.6 million in Q2 2024. This shift is largely due to a substantial increase in acquired in-process research and development expenses Condensed Consolidated Statements of Income (Loss) (Unaudited, In thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Product sales, net | $985,571 | $964,144 | $1,824,989 | $1,806,246 | | Royalties and contract revenues | $60,141 | $59,681 | $118,564 | $119,562 | | **Total revenues** | **$1,045,712** | **$1,023,825** | **$1,943,553** | **$1,925,808** | | Cost of product sales (excluding amortization of acquired developed technologies) | $116,268 | $109,902 | $220,888 | $205,389 | | Selling, general and administrative | $358,399 | $338,523 | $872,412 | $690,235 | | Research and development | $189,972 | $220,734 | $370,624 | $443,581 | | Intangible asset amortization | $162,103 | $155,223 | $316,551 | $310,953 | | Acquired in-process research and development | $905,362 | — | $905,362 | $10,000 | | **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 | | Interest expense, net | $(47,363) | $(62,023) | $(101,069) | $(128,139) | | Foreign exchange gain (loss) | $(1,799) | $507 | $(2,012) | $(1,186) | | Income (loss) before income tax benefit and equity in loss of investees | $(735,554) | $137,927 | $(845,365) | $136,325 | | Income tax benefit | $(17,170) | $(30,653) | $(34,982) | $(18,984) | | Equity in loss of investees | $86 | $12 | $628 | $1,359 | | **Net income (loss)** | **$(718,470)** | **$168,568** | **$(811,011)** | **$153,950** | | Net income (loss) per ordinary share: Basic | $(11.74) | $2.68 | $(13.28) | $2.45 | | Net income (loss) per ordinary share: Diluted | $(11.74) | $2.49 | $(13.28) | $2.35 | | Weighted-average ordinary shares used in per share calculations - basic | 61,194 | 62,882 | 61,087 | 62,710 | | Weighted-average ordinary shares used in per share calculations - diluted | 61,194 | 69,625 | 61,087 | 69,684 | [Condensed Consolidated Balance Sheets](index=11&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows a decrease in total assets to $10.94 billion from $12.01 billion at December 31, 2024, primarily driven by a reduction in cash and cash equivalents. Current liabilities significantly increased due to a higher current portion of long-term debt Condensed Consolidated Balance Sheets (Unaudited, In thousands) | Asset/Liability | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $1,189,880 | $2,412,864 | | Investments | $480,000 | $580,000 | | Accounts receivable, net | $714,004 | $716,765 | | Inventories | $504,989 | $480,445 | | Total current assets | $3,350,433 | $4,629,028 | | Property, plant and equipment, net | $184,975 | $173,413 | | Intangible assets, net | $4,768,987 | $4,755,695 | | Goodwill | $1,843,974 | $1,716,323 | | **Total assets** | **$10,944,141** | **$12,012,257** | | **LIABILITIES AND SHAREHOLDERS' EQUITY** | | | | Accounts payable | $89,366 | $77,869 | | Accrued liabilities | $874,811 | $910,947 | | Current portion of long-term debt | $1,028,478 | $31,000 | | Total current liabilities | $2,071,205 | $1,038,573 | | Long-term debt, less current portion | $4,335,616 | $6,077,640 | | Total shareholders' equity | $3,706,359 | $4,093,756 | | **Total liabilities and shareholders' equity** | **$10,944,141** | **$12,012,257** | [Summary of Cash Flows](index=11&type=section&id=Summary%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash provided by operating activities was $518.6 million, a decrease from $598.6 million in the prior year. Net cash used in investing activities significantly increased to $(809.9) million, primarily due to the Chimerix acquisition, and net cash used in financing activities also rose to $(938.0) million Summary of Cash Flows (Unaudited, In thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 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) | | Effect of exchange rates on cash and cash equivalents | $6,319 | $(2,457) | | **Net decrease in cash and cash equivalents** | **$(1,222,984)** | **$(150,508)** | [Reconciliations of GAAP to Non-GAAP Information](index=12&type=section&id=Reconciliations%20of%20GAAP%20to%20Non-GAAP%20Information) This section provides detailed reconciliations of GAAP to non-GAAP financial measures for various periods and guidance [Net Income (Loss) and EPS Reconciliation](index=12&type=section&id=Net%20Income%20%28Loss%29%20and%20EPS%20Reconciliation) This section provides a reconciliation of GAAP net income (loss) and EPS to non-GAAP adjusted figures, detailing adjustments for intangible asset amortization, share-based compensation, acquisition accounting inventory fair value step-up, integration expenses, and their income tax effects. For Q2 2025, GAAP net loss was $(718.5) million, while non-GAAP adjusted net loss was $(504.8) million Reconciliation of GAAP to Non-GAAP Adjusted Net Income (Loss) and EPS (Unaudited, In thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 (Net Loss) | Three Months Ended June 30, 2025 (LPS) | Three Months Ended June 30, 2024 (Net Income) | Three Months Ended June 30, 2024 (EPS) | | :------------------------------------ | :------------------------------------------ | :--------------------------------------- | :------------------------------------------ | :--------------------------------------- | | GAAP reported | $(718,470) | $(11.74) | $168,568 | $2.49 | | Intangible asset amortization | 162,103 | 2.65 | 155,223 | 2.23 | | Share-based compensation expense | 64,501 | 1.05 | 56,654 | 0.81 | | Acquisition accounting inventory fair value step-up | 37,109 | 0.61 | 33,243 | 0.48 | | Integration related expenses | 9,368 | 0.15 | — | — | | Income tax effect of above adjustments | (59,460) | (0.97) | (53,032) | (0.76) | | **Non-GAAP adjusted** | **$(504,849)** | **$(8.25)** | **$360,656** | **$5.25** | - Diluted EPS for 2024 periods included **6.4 million shares** related to the assumed conversion of 2026 Notes and associated interest expense add-back[45](index=45&type=chunk) - Integration related expenses in 2025 are specifically with respect to the Chimerix Acquisition[46](index=46&type=chunk) [Certain Line Items Reconciliation (Three Months)](index=13&type=section&id=Certain%20Line%20Items%20Reconciliation%20%28Three%20Months%29) This reconciliation details the adjustments made to specific GAAP operating expense line items to arrive at their non-GAAP adjusted counterparts for the three months ended June 30, 2025 and 2024. Key adjustments include intangible asset amortization, share-based compensation, and acquisition accounting inventory fair value step-up, impacting gross margin, SG&A, R&D, and the effective tax rate Reconciliation of GAAP to Non-GAAP Adjusted Certain Line Items (Three Months Ended June 30, 2025) (Unaudited, In thousands, except percentages) | Metric | GAAP Reported | Non-GAAP Adjustments | Non-GAAP Adjusted | | :-------------------------------- | :------------ | :------------------- | :---------------- | | Cost of product sales | $116,268 | $(39,960) | $76,308 | | Gross margin | 88.2% | 4.1% | 92.3% | | SG&A | $358,399 | $(48,077) | $310,322 | | R&D | $189,972 | $(22,941) | $167,031 | | Intangible asset amortization | $162,103 | $(162,103) | $0 | | Acquired IPR&D | $905,362 | $0 | $905,362 | | Interest expense, net | $47,363 | $0 | $47,363 | | Income tax expense (benefit) | $(17,170) | $59,460 | $42,290 | | Effective tax rate | 2.3% | (11.4)% | (9.1)% | Reconciliation of GAAP to Non-GAAP Adjusted Certain Line Items (Three Months Ended June 30, 2024) (Unaudited, In thousands, except percentages) | Metric | GAAP Reported | Non-GAAP Adjustments | Non-GAAP Adjusted | | :-------------------------------- | :------------ | :------------------- | :---------------- | | Cost of product sales | $109,902 | $(37,489) | $72,413 | | Gross margin | 88.6% | 3.9% | 92.5% | | SG&A | $338,523 | $(35,137) | $303,386 | | R&D | $220,734 | $(17,271) | $203,463 | | Intangible asset amortization | $155,223 | $(155,223) | $0 | | Acquired IPR&D | $0 | $0 | $0 | | Interest expense, net | $62,023 | $0 | $62,023 | | Income tax expense (benefit) | $(30,653) | $53,032 | $22,379 | | Effective tax rate | (22.2)% | 28.0% | 5.8% | [Certain Line Items Reconciliation (Six Months)](index=14&type=section&id=Certain%20Line%20Items%20Reconciliation%20%28Six%20Months%29) This section provides the reconciliation of GAAP to non-GAAP adjusted certain line items for the six months ended June 30, 2025 and 2024. Similar to the quarterly reconciliation, it details adjustments for non-cash items and their tax effects, showing the impact on cost of product sales, gross margin, SG&A, R&D, and the effective tax rate over the half-year period Reconciliation of GAAP to Non-GAAP Adjusted Certain Line Items (Six Months Ended June 30, 2025) (Unaudited, In thousands, except percentages) | Metric | GAAP Reported | Non-GAAP Adjustments | Non-GAAP Adjusted | | :-------------------------------- | :------------ | :------------------- | :---------------- | | Cost of product sales | $220,888 | $(74,889) | $145,999 | | Gross margin | 87.9% | 4.1% | 92.0% | | SG&A | $872,412 | $(89,751) | $782,661 | | R&D | $370,624 | $(43,871) | $326,753 | | Intangible asset amortization | $316,551 | $(316,551) | $0 | | Acquired IPR&D | $905,362 | $0 | $905,362 | | Interest expense, net | $101,069 | $0 | $101,069 | | Income tax expense (benefit) | $(34,982) | $113,667 | $78,685 | | Effective tax rate | 4.1% | (28.7)% | (24.6)% | Reconciliation of GAAP to Non-GAAP Adjusted Certain Line Items (Six Months Ended June 30, 2024) (Unaudited, In thousands, except percentages) | Metric | GAAP Reported | Non-GAAP Adjustments | Non-GAAP Adjusted | | :-------------------------------- | :------------ | :------------------- | :---------------- | | Cost of product sales | $205,389 | $(68,828) | $136,561 | | Gross margin | 88.6% | 3.8% | 92.4% | | SG&A | $690,235 | $(75,350) | $614,885 | | R&D | $443,581 | $(36,103) | $407,478 | | Intangible asset amortization | $310,953 | $(310,953) | $0 | | Acquired IPR&D | $10,000 | $0 | $10,000 | | Interest expense, net | $128,139 | $0 | $128,139 | | Income tax expense (benefit) | $(18,984) | $106,098 | $87,114 | | Effective tax rate | (13.9)% | 27.8% | 13.9% | [2025 Guidance Reconciliation](index=15&type=section&id=2025%20Guidance%20Reconciliation) This section reconciles the 2025 GAAP net loss and diluted LPS guidance to the non-GAAP adjusted net income and diluted EPS guidance. It outlines the projected impact of intangible asset amortization, share-based compensation, acquisition accounting inventory fair value step-up, integration expenses, and their income tax effects on the full-year outlook Reconciliation of 2025 GAAP Net Loss and Diluted LPS to Non-GAAP Adjusted Net Income and Diluted EPS Guidance (Unaudited, In millions, except per share amounts) | Metric | Net Income (Loss) | Diluted EPS/(LPS) | | :------------------------------------------ | :---------------- | :---------------- | | GAAP | $(565) - $(450) | $(9.25) - $(7.50) | | Intangible asset amortization | 610 - 660 | 9.70 - 10.60 | | Share-based compensation expense | 240 - 270 | 3.80 - 4.35 | | Acquisition accounting inventory fair value step-up | 135 - 155 | 2.15 - 2.50 | | Integration related expenses | 20 - 25 | 0.30 - 0.40 | | Income tax effect of above adjustments | (215) - (235) | (3.40) - (3.75) | | Effect of potentially dilutive ordinary shares on non-GAAP adjusted EPS | - | 0.05 - 0.20 | | **Non-GAAP adjusted** | **$300 - $350** | **$4.80 - $5.60** | | Weighted-average ordinary shares used in per share calculations - GAAP | 61 - 62 | N/A | | Weighted-average ordinary shares used in per share calculations - non-GAAP | 62 - 63 | N/A |

Jazz Pharmaceuticals (JAZZ) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on Aug ...

Company Announcement - Jazz Pharmaceuticals plc will report its 2025 second quarter financial results on August 5, 2025, after the U.S. financial markets close [1] - A live audio webcast will be hosted by company management at 4:30 p.m. EDT / 9:30 p.m. IST to discuss the financial results and provide a business update [1] Registration and Replay Information - Interested parties can register for the call in advance through the Investors section of the Jazz Pharmaceuticals website [2] - It is recommended that participants register at least 15 minutes prior to the scheduled webcast to ensure a timely connection [2] - A replay of the webcast will be available on the Investors section of the Jazz Pharmaceuticals website [2] Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on innovating to transform the lives of patients with serious diseases [3] - The company has a diverse portfolio of marketed medicines, including therapies for sleep disorders, epilepsy, and a growing portfolio of cancer treatments [3] - Jazz Pharmaceuticals is headquartered in Dublin, Ireland, with research and development laboratories and manufacturing facilities in multiple countries [3]