Dordaviprone

– Total revenues of $898 million in 1Q25 –– Xywav® and Epidiolex® revenues grew 9% and 10% year-over-year, respectively, in 1Q25 –– Completed submission of sNDA for Zepzelca® in 1L ES-SCLC –– Affirming 2025 revenue guidance; updating financial guidance to reflect Chimerix acquisition and impact of certain Xyrem® antitrust litigation settlements – DUBLIN , May 6, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2025 and updated financial guidance for 2025. "In the first quarter of 2025, our focus on commercial execution resulted in total revenues of $898 million , led by the strong performance of Xywav and Epidiolex. In addition, our team continues to receive positive feedback from healthcare providers on the launch of Ziihera® in its first approved indication of 2L HER2+ BTC. We are affirming our 2025 total revenue guidance range of $4.15 - $4.40 billion, reflecting our confidence in our commercial portfolio delivering top-line growth this year," said Bruce Cozadd , chairman and chief executive officer, Jazz Pharmaceuticals . "We continue to make meaningful progress across our pipeline. We are pleased to report that we have submitted a supplemental New Drug Application for Zepzelca for maintenance therapy in first-line extensive-stage small cell lung cancer. In addition, we recently completed the acquisition of Chimerix, adding a near-term commercial opportunity to our late-stage pipeline that addresses a significant unmet need for patients with H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults. We also advanced multiple trials across our zanidatamab development program and expect top-line data readout from the HERIZON-GEA-01 trial in 1L GEA in the second half of 2025." Key Highlights Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 2H25. Submitted sNDA for Zepzelca in combination with atezolizumab (Tecentriq®) as maintenance therapy in 1L ES-SCLC based on the potentially practice-changing results from the Phase 3 IMforte trial. Data from trial to be presented at the 2025 ASCO Annual Meeting in June 2025 . Acquisition of Chimerix added dordaviprone to late-stage pipeline, representing near-term commercial opportunity; PDUFA target data of August 18, 2025 . Top-line growth expected in 2025; affirmed 2025 total revenue guidance of $4.15 - $4.40 billion , representing 5% growth at the midpoint. Total revenue guidance is underpinned by expected continued growth of Jazz's diversified commercial portfolio. Total revenue guidance is underpinned by expected continued growth of Jazz's diversified commercial portfolio. Business Updates Commercial Updates Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution: Xywav net product sales increased 9% to $344.8 million in 1Q25 compared to 1Q24. Meaningful Xywav net patient adds in 1Q25 (approximately 450 patients) with approximately 14,600 active Xywav patients exiting 1Q25, comprised of: Approximately 10,375 narcolepsy patients. Approximately 4,225 idiopathic hypersomnia (IH) patients, with 325 net patient adds. Two presentations at the American Academy of Neurology Annual Meeting provided updated results from the open-label, single-arm, Phase 4 DUET trial of adults with narcolepsy or IH. The results demonstrated statistically significant improvements from baseline to end of treatment in Epworth Sleepiness Scale (ESS) scores, reduced sleep stage shifts, increased deep sleep and reduced number of awakenings among adults with narcolepsy treated with Xywav. In adults with IH, Xywav treatment showed improvements in ESS and IH Severity Scale scores. Xywav is the only low-sodium oxybate, the #1 branded treatment for narcolepsy1 and the only U.S. Food and Drug Administration (FDA)-approved therapy to treat IH. Approximately 10,375 narcolepsy patients. Approximately 4,225 idiopathic hypersomnia (IH) patients, with 325 net patient adds. Xyrem (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties: Xyrem net product sales decreased 42% to $37.2 million in 1Q25 compared to 1Q24. Royalties from high-sodium oxybate AGs were $48 .9 million in 1Q25. Epidiolex/Epidyolex® (cannabidiol): Epidiolex/Epidyolex net product sales increased 10% to $217.7 million in 1Q25 compared to 1Q24. Outside of the U.S., Epidyolex is approved in more than 35 countries. Remain confident in achieving blockbuster status for Epidiolex/Epidyolex in 2025. Rylaze®/Enrylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn): Rylaze/Enrylaze net product sales decreased 8% to $94.2 million in 1Q25 compared to 1Q24. This decrease was driven by headwinds from an update to Children's Oncology Group (COG) pediatric treatment protocols for acute lymphoblastic leukemia made in mid-2024 that impacted timing of asparaginase administration. The impact to Rylaze net product sales due to COG protocol updates is expected to normalize during 2Q25. Zepzelca (lurbinectedin): Zepzelca net product sales decreased 16% to $63.0 million in 1Q25 compared to 1Q24. This decrease was driven by increased competition in second-line (2L) small cell lung cancer (SCLC) and treatment protocol updates delaying progression in first-line (1L) limited-stage SCLC patients to the 2L setting. The Company submitted a supplemental New Drug Application (sNDA) for Zepzelca's use in combination with atezolizumab as maintenance therapy in 1L extensive-stage (ES) SCLC for patients who have not progressed after induction chemotherapy. Potentially practice-changing data from the Phase 3 IMforte trial, which showed a statistically significant and clinically meaningful benefit in both progression-free survival (PFS) and overall survival for the Zepzelca and atezolizumab combination for ES-SCLC patients receiving this treatment in the first-line maintenance setting, was accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. This is the first presentation of data from the IMforte trial. Ziihera (zanidatamab-hrii): Ziihera net product sales were $2.0 million in 1Q25 following product launch in December 2024 . On April 25, 2025 , the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab in 2L BTC (biliary tract cancer). The CHMP recommendation is being reviewed by the European Commission . __________________________ 1 Based on 1Q25 Xywav net product sales. Corporate Development Chimerix Acquisition: The Company completed its acquisition of Chimerix in April 2025 , adding dordaviprone to its late-stage pipeline. Dordaviprone is a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults. Key Pipeline Highlights Zanidatamab: The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is expected to read out in 2H25 based on the most recent assessment of progression events. Recruitment for the trial has been completed. New data from an ongoing Phase 2 trial of zanidatamab in combination with chemotherapy for the first-line treatment of HER2-positive metastatic GEA, including more mature overall survival data, was accepted for a rapid oral presentation at the 2025 ASCO Annual Meeting. The Phase 3 EmpowHER-BC-303 trial to evaluate zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous T-DXd treatment continues to enroll patients. The Phase 2 pan-tumor trial to evaluate HER2-positive solid tumors continues to enroll patients. Dordaviprone: A New Drug Application for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was accepted and granted Priority Review by FDA. FDA has set a target Prescription Drug User Fee Act (PDUFA) action date of August 18, 2025 . The ongoing Phase 3 ACTION trial is evaluating dordaviprone in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting. Data on the efficacy and safety of dordaviprone from prospective clinical trials of adult and pediatric recurrent H3 K27M-mutant diffuse glioma patients was accepted for an oral presentation at the 2025 ASCO Annual Meeting. Financial Highlights Three Months Ended March 31 , (In thousands, except per share amounts) 2025 2024 Total revenues $ 897,841 $ 901,983 GAAP net loss $ (92,541) $ (14,618) Non-GAAP adjusted net income1 $ 105,233 $ 178,430 GAAP loss per share $ (1.52) $ (0.23) Non-GAAP adjusted EPS1 $ 1.68 $ 2.63 ____________________________ 1. Commencing with the first quarter of 2025, we are no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures and for the purposes of comparability, non-GAAP adjusted financial measures for the first quarter of 2024 have been updated to reflect this change. See "Non-GAAP Financial Measures" below. GAAP net loss for 1Q25 was $(92.5) million , or $(1.52) per diluted share, compared to $(14.6) million , or $(0.23) per diluted share, for 1Q24. Non-GAAP adjusted net income for 1Q25 was $105 .2 million, or $1.68 per diluted share, compared to $178 .4 million, or $2.63 per diluted share, for 1Q24. The GAAP net loss and non-GAAP adjusted net income for 1Q25 included an expense of $172.0 million related to certain Xyrem antitrust litigation settlements, which impacted our GAAP and non-GAAP results by $146.3 million (net of tax of $25.7 million ) or $2.38 per share on a GAAP basis and $2.34 per share on a non-GAAP adjusted basis. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release. Total Revenues Three Months Ended March 31 , (In thousands) 2025 2024 Xywav $ 344,804 $ 315,300 Xyrem 37,241 64,232 Epidiolex/Epidyolex 217,737 198,716 Sativex 5,407 2,735 Total Neuroscience 605,189 580,983 Rylaze/Enrylaze 94,233 102,750 Zepzelca 63,033 75,100 Defitelio/defibrotide 40,662 47,676 Vyxeos 29,544 32,023 Ziihera 1,975 — Total Oncology 229,447 257,549 Other 4,782 3,570 Product sales, net 839,418 842,102 High-sodium oxybate AG royalty revenue 48,946 49,947 Other royalty and contract revenues 9,477 9,934 Total revenues $ 897,841 $ 901,983 Total revenues for 1Q25 were in line with 1Q24. Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $654 .1 million in 1Q25, an increase of 4% compared to $630.9 million in 1Q24. The increase in 1Q25 was due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales. Oncology net product sales were $229 .4 million in 1Q25, a decrease of 11% compared to $257 .5 million in 1Q24. The decrease in 1Q25 was primarily due to lower net product sales of Zepzelca, Rylaze/Enrylaze and Defitelio/defibrotide. In 1Q25, Rylaze net product sales were negatively impacted due to an update to the COG pediatric treatment protocols for ALL, which impacts the timing of asparaginase administration. Operating Expenses and Effective Tax Rate Three Months Ended March 31 , (In thousands, except percentages) 2025 2024 GAAP: Cost of product sales $ 104,620 $ 95,487 Gross margin 87.5 % 88.7 % Selling, general and administrative $ 514,013 $ 351,712 % of total revenues 57.2 % 39.0 % Research and development $ 180,652 $ 222,847 % of total revenues 20.1 % 24.7 % Acquired in-process research and development $ — $ 10,000 Income tax (benefit) expense1 $ (17,812) $ 11,669 Effective tax rate 1 16.2 % (728.4) % _________________________ 1. The GAAP income tax benefit in 1Q25 related primarily to the tax impact of certain Xyrem antitrust litigation settlements. The GAAP income tax expense in 1Q24 related primarily to tax shortfalls from share-based compensation. Three Months Ended March 31 , (In thousands, except percentages) 2025 2024 Non-GAAP adjusted: Cost of product sales $ 69,691 $ 64,148 Gross margin 91.7 % 92.4 % Selling, general and administrative $ 472,339 $ 311,499 % of total revenues 52.6 % 34.5 % Research and development $ 159,722 $ 204,015 % of total revenues 17.8 % 22.6 % Acquired in-process research and development $ — $ 10,000 Income tax expense1 $ 36,394 $ 64,735 Effective tax rate1 25.6 % 26.5 % _________________________ 1. The non-GAAP income tax expense decreased in the three months ended March 31, 2025 , compared to the same period in 2024, primarily due to the tax impact of certain Xyrem antitrust settlements in 1Q25. Changes in operating expenses in 1Q25 over the prior year period are primarily due to the following: Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 1Q25 compared to the same period in 2024, primarily due to changes in product mix and higher inventory provisions. SG&A expenses, on a GAAP and non-GAAP adjusted basis, increased in 1Q25 compared to the same period in 2024, primarily due to certain Xyrem antitrust litigation settlements of $172.0 million incurred in 1Q25. Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 1Q25 primarily due to lower clinical study costs primarily related to zanidatamab, as a result of timing of clinical trial activities, and JZP385 (essential tremor) and JZP150 (post-traumatic stress disorder) following discontinuation of these programs. Acquired in-process research and development (IPR&D) in 1Q24, on a GAAP and non-GAAP adjusted basis, related to an upfront payment made in connection with our asset purchase agreement with Redx Pharma plc . Cash Flow and Balance Sheet As of March 31, 2025 , cash, cash equivalents and investments were $2 .6 billion, and the outstanding principal balance of the Company's long-term debt was $5 .4 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $885 .0 million. For the three months ended March 31, 2025 , the Company generated $429 .8 million of cash from operations reflecting strong business performance and continued financial discipline. In January 2025 , the Company made a voluntary prepayment of $750.0 million principal amount on the Term Loan B. In April 2025 , the Company acquired Chimerix for a total consideration of approximately $935 million , which was funded with cash and cash equivalents. 2025 Financial Guidance1 Jazz Pharmaceuticals is updating its full year 2025 financial guidance primarily to reflect the impact of the Chimerix acquisition and certain Xyrem antitrust litigation settlements. Guidance provided as of (In millions) May 6, 2025 February 25, 2025 Total Revenues $4,150 - $4,400 $4,150 - $4,400 GAAP: (In millions, except per share amounts and percentages) May 6, 2025 February 25, 2025 Gross margin % 88 % 88 % SG&A expenses $1,640 - $1,723 $1,404 - $1,483 R&D expenses $835 - $895 $792 - $851 Acquired in-process research and development $870 - $900 2 - Effective tax rate 0% - 10% (5)% - 10% Net income (loss) $(615) - $(450) 3 $560 - $720 Net income (loss) per diluted share $(10.00) - $(7.50) 3 $9.15 - $11.50 Weighted-average ordinary shares used in per share calculations 61 - 62 62 - 63 Non-GAAP: (In millions, except per share amounts and percentages) May 6, 2025 February 25, 2025 Gross margin % 92%4,8 92 % SG&A expenses $1,470 - $1,530 5,8 $1,250 - $1,310 R&D expenses $760 - $810 6,8 $720 - $770 Acquired in-process research and development $870 - $900 2 - Effective tax rate 35% - 45%7,8 13% - 15% Net income $250 - $350 3,8 $1,400 - $1,500 Net income per diluted share $4.00 - $5.60 3,8 $22.50 - $24.00 Weighted-average ordinary shares used in per share calculations 62 - 63 62 - 63 ___________________________ 1. The Company's updated financial guidance includes the anticipated results of the acquired Chimerix operations from the date of acquisition April 21, 2025 . 2. Represents consideration allocated to IPR&D in the Chimerix acquisition, which the Company expects to account for as an asset acquisition. This guidance remains subject to final acquisition accounting adjustments. 3. The projected GAAP net loss and non-GAAP adjusted net income, include an acquired IPR&D expense relating to the acquisition of Chimerix of $885.0 million , at the midpoint, and certain Xyrem antitrust litigation settlements of $172.0 million , which are expected to impact the Company's GAAP and non-GAAP projected results by $1.0 billion (net of tax of $25.7 million ) or $16.64 per share on a GAAP basis and $16.50 per share on a non-GAAP adjusted basis. 4. Excludes $135-$155 million of amortization of acquisition-related inventory fair value step-up, $14-$16 million of share-based compensation expense and $1 million of integration related expenses. 5. Excludes $154-$173 million of share-based compensation expense and $16-$20 million of integration related expenses. 6. Excludes $72-$81 million of share-based compensation expense and $3-$4 million of integration related expense. 7. Excludes (35)% from the GAAP effective tax rate of 0%-10% relating to the income tax effect of adjustments between GAAP net loss and non-GAAP adjusted net income, resulting in a non-GAAP adjusted effective tax rate of 35%-45%. 8. See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of 2025 GAAP Net Loss And Diluted LPS To Non-GAAP Adjusted Net Income and Diluted EPS Guidance" at the end of this press release. Conference Call Details Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET ( 9:30 p.m. IST ) to provide a business and financial update and discuss its 2025 first quarter results. Audio webcast/conference call: U.S. Dial-In Number: +1 800 715 9871Ireland Dial-In Number: +353 1800 943 926Additional global dial-in numbers are available here.Passcode: 5080203 Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Non-GAAP Financial Measures To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the Company presents non-GAAP adjusted net income (and the related per share measure) and its line-item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (and the related per share measure) and its line-item components exclude from GAAP reported net loss (and the related per share measure) and its line-item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (and the related per share measure), adjust for the income tax effect of the non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income, including non-GAAP adjusted cost of product sales, SG&A expenses and R&D expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income measure. The Company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts and that each of these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period, to its forward-looking guidance, and to identify operating trends in the Company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the Company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the Company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles in the reconciliation tables that follow. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. In this regard, commencing with the first quarter of 2025, the Company is no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures. For purposes of comparability, non-GAAP adjusted financial measures for the first quarter of 2024 have been updated to reflect this change. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Caution Concerning Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the Company's 2025 financial guidance and the Company's expectations related thereto, including with respect to anticipated catalysts; expectations that Epidiolex will achieve blockbuster status in 2025; the ability to generate growth and long-term shareholder value; anticipated benefits and expenses relating to the Company's acquisition of Chimerix; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities and submissions related thereto; the potential for a near-term commercial launch of dordaviprone in the U.S. if approved; the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of dordaviprone in recurrent H3 K27M-mutant diffuse glioma and extend to use in first-line patients; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA; and the Company's development, regulatory and commercialization strategy; the Company's expectations with respect to its products and product candidates and the potential of the Company's products and product candidates and the potential regulatory path related thereto, including Zepzelca's potential to change current practice in 1L ES-SCLC; the Company's capital allocation and corporate development strategy; the potential successful future development, manufacturing, regulatory and commercialization activities; the Company's ability to realize the commercial potential of its products; the Company's net product sales and goals for net product sales from new and acquired products; the Company's views and expectations relating to its patent portfolio, including with respect to expected patent protection, as well as expectations with respect to exclusivity; the Company's clinical trials confirming clinical benefit or enabling regulatory submissions; planned or anticipated regulatory submissions and filings, and the anticipated timing thereof; potential regulatory approvals; and other statements that are not historical facts. These forward-looking statements are based on the Company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of, and revenue from, Xywav, Rylaze and Epidiolex/Epidyolex and other marketed products; the introduction of new products into the U.S. market that compete with, or otherwise disrupt the market for the Company's products and product candidates; effectively launching and commercializing the Company's other products and product candidates; the successful completion of development and regulatory activities with respect to the Company's product candidates, obtaining and maintaining adequate coverage and reimbursement for the Company's products; the time-consuming and uncertain regulatory approval process, including the risk that the Company's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; geopolitical events, including international tariffs and trade restrictions and the conflict between Russia and Ukraine and related sanctions; macroeconomic conditions, including global financial markets, rising interest rates and inflation and recent and potential banking disruptions; regulatory initiatives and changes in tax laws; market volatility; protecting and enhancing the Company's intellectual property rights and the Company's commercial success being dependent upon the Company obtaining, maintaining and defending intellectual property protection and exclusivity for its products and product candidates; the ability of the parties to obtain court approval of certain Xyrem class action settlement agreements and the risk that the Company may incur other charges or cash expenditures not currently contemplated due to unanticipated events that may occur, including in connection with certain Xyrem class action settlement agreements, and the risk that the Company is unable to reach settlement agreements with other Xyrem antitrust plaintiffs that are not party to certain Xyrem class action settlement agreements; delays or problems in the supply or manufacture of the Company's products and product candidates; complying with applicable U.S. and non- U.S. regulatory requirements, including those governing the research, development, manufacturing and distribution of controlled substances; government investigations, legal proceedings and other actions; identifying and consummating corporate development transactions, financing these transactions and successfully integrating acquired product candidates, products and businesses, including Chimerix and the acquired product candidate dordaviprone; the Company's ability to realize the anticipated benefits of its corporate development transactions and its collaborations and license agreements with third parties; the sufficiency of the Company's cash flows and capital resources; the Company's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the Company's ability to meet its projected long-term goals and objectives, in the time periods that the Company anticipates, or at all, and the inherent uncertainty and significant judgments and assumptions underlying the Company's long-term goals and objectives; fluctuations in the market price and trading volume of the Company's ordinary shares; the timing and availability of alternative investment opportunities; and other risks and uncertainties affecting the Company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2024 , and future filings and reports by the Company, including the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 . Other risks and uncertainties of which the Company is not currently aware may also affect the Company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. JAZZ PHARMACEUTICALS PLC CONDENSED CONSOLIDATED STATEMENTS OF LOSS(In thousands, except per share amounts)(Unaudited) Three Months Ended March 31 , 2025 2024 Revenues: Product sales, net $ 839,418 $ 842,102 Royalties and contract revenues 58,423 59,881 Total revenues 897,841 901,983 Operating expenses: Cost of product sales (excluding amortization of acquired developed technologies) 104,620 95,487 Selling, general and administrative 514,013 351,712 Research and development 180,652 222,847 Intangible asset amortization 154,448 155,730 Acquired in-process research and development — 10,000 Total operating expenses 953,733 835,776 Income (loss) from operations (55,892) 66,207 Interest expense, net (53,706) (66,116) Foreign exchange loss (213) (1,693) Loss before income tax (benefit) expense and equity in loss of investees (109,811) (1,602) Income tax (benefit) expense (17,812) 11,669 Equity in loss of investees 542 1,347 Net loss $ (92,541) $ (14,618) Net loss per ordinary share: Basic and diluted $ (1.52) $ (0.23) Weighted-average ordinary shares used in per share calculations - basic and diluted 60,979 62,537 JAZZ PHARMACEUTICALS PLC CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands)(Unaudited) March 31 ,2025 December 31 ,2024 ASSETS Current assets: Cash and cash equivalents $ 1,861,946 $ 2,412,864 Investments 710,000 580,000 Accounts receivable, net of allowances 652,992 716,765 Inventories 492,776 480,445 Prepaid expenses 150,280 177,411 Other current assets 259,823 261,543 Total current assets 4,127,817 4,629,028 Property, plant and equipment, net 178,869 173,413 Operating lease assets 49,181 53,582 Intangible assets, net 4,718,158 4,755,695 Goodwill 1,760,045 1,716,323 Deferred tax assets, net 575,097 560,245 Deferred financing costs 8,999 9,489 Other non-current assets 116,516 114,482 Total assets $ 11,534,682 $ 12,012,257 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 95,930 $ 77,869 Accrued liabilities 1,063,918 910,947 Current portion of long-term debt 31,000 31,000 Income taxes payable 31,762 18,757 Total current liabilities 1,222,610 1,038,573 Long-term debt, less current portion 5,336,481 6,077,640 Operating lease liabilities, less current portion 38,780 38,938 Deferred tax liabilities, net 670,801 676,736 Other non-current liabilities 91,119 86,614 Total shareholders' equity 4,174,891 4,093,756 Total liabilities and shareholders' equity $ 11,534,682 $ 12,012,257 JAZZ PHARMACEUTICALS PLC SUMMARY OF CASH FLOWS (In thousands)(Unaudited) Three Months Ended March 31 , 2025 2024 Net cash provided by operating activities $ 429,784 $ 267,229 Net cash used in investing activities (168,931) (271,904) Net cash used in financing activities (813,466) (56,552) Effect of exchange rates on cash and cash equivalents 1,695 (1,698) Net decrease in cash and cash equivalents $ (550,918) $ (62,925) JAZZ PHARMACEUTICALS PLC RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION(In thousands, except per share amounts)(Unaudited) Three Months Ended March 31 , 2025 2024 NetIncome(Loss) DilutedEPS/(LPS)1 Net Income(Loss) Diluted EPS/(LPS)1 GAAP reported $ (92,541) $ (1.52) $ (14,618) $ (0.23) Intangible asset amortization 154,448 2.47 155,730 2.23 Share-based compensation expense 67,653 1.08 61,441 0.88 Acquisition accounting inventory fair value step-up 29,880 0.48 28,943 0.41 Income tax effect of above adjustments (54,207) (0.87) (53,066) (0.75) Effect of potentially dilutive ordinary shares on non-GAAP adjusted EPS1 — 0.04 — 0.09 Non-GAAP adjusted $ 105,233 $ 1.68 $ 178,430 $ 2.63 Weighted-average ordinary shares used in diluted per share calculations - GAAP1 60,979 62,537 Dilutive effect of employee equity incentive and purchase plans1 1,564 788 Dilutive effect of the 2026 Notes1 — 6,418 Weighted-average ordinary shares used in diluted per share calculations - non-GAAP1 62,543 69,743 ________________________________________________ Explanation of Adjustments and Certain Line Items: 1. Potentially dilutive ordinary shares from Jazz's employee equity incentive and purchase plans were excluded from the calculation of diluted loss per ordinary share, or LPS, on a GAAP basis, for the three months ended March 31, 2025 and March 31, 2024 because their effect would have been anti-dilutive. Diluted earnings per ordinary share, or EPS, was calculated using the "if-converted" method in relation to the 2.000% exchangeable senior notes due 2026, or the 2026 Notes. In July 2024 , we made the irrevocable election to net share settle the 2026 Notes. As a result, the assumed issuance of ordinary shares upon exchange of the 2026 Notes has only been included in the calculation of diluted EPS, on a non-GAAP adjusted basis, in the three months ended March 31, 2024 . The potential issue of ordinary shares upon exchange of the 2026 Notes was anti-dilutive and had no impact on GAAP reported LPS for the three months ended March 31, 2024 . JAZZ PHARMACEUTICALS PLC RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATIONCERTAIN LINE ITEMS - FOR THE THREE MONTHS ENDED MARCH 31, 2025 (In thousands, except percentages)(Unaudited) Three months ended March 31, 2025 Cost of productsales Gross margin Selling, general and administrative Research and development Intangible asset amortization Interestexpense,net Income tax(benefit) expense Effective tax rate GAAP Reported $ 104,620 87.5 % $ 514,013 $ 180,652 $ 154,448 $ 53,706 $ (17,812) 16.2 % Non-GAAP Adjustments: Intangible asset amortization — — — — (154,448) — — — Share-based compensationexpense (5,049) 0.6 (41,674) (20,930) — — — — Acquisition accounting inventoryfair value step-up (29,880) 3.6 — — — — — — Income tax effect of aboveadjustments — — — — — — 54,206 9.4 Total of non-GAAP adjustments (34,929) 4.2 (41,674) (20,930) (154,448) — 54,206 9.4 Non-GAAP Adjusted $ 69,691 91.7 % $ 472,339 $ 159,722 $ — $ 53,706 $ 36,394 25.6 % Three months ended March 31, 2024 Cost ofproduct sales Gross margin Selling, general and administrative Research and development Intangibleasset amortization AcquiredIPR&D Interestexpense, net Income taxexpense Effectivetax rate GAAP Reported $ 95,487 88.7 % $ 351,712 $ 222,847 $ 155,730 $ 10,000 $ 66,116 $ 11,669 (728.4) % Non-GAAP Adjustments: Intangible asset amortization — — — — (155,730) — — — — Share-based compensation expense (2,396) 0.3 (40,213) (18,832) — — — — — Acquisition accountinginventory fair value step-up (28,943) 3.4 — — — — — — — Income tax effect of aboveadjustments — — — — — — — 53,066 754.9 Total of non-GAAPadjustments (31,339) 3.7 (40,213) (18,832) (155,730) — — 53,066 754.9 Non-GAAP Adjusted $ 64,148 92.4 % $ 311,499 $ 204,015 $ — $ 10,000 $ 66,116 $ 64,735 26.5 % JAZZ PHARMACEUTICALS PLC RECONCILIATION OF 2025 GAAP NET LOSS AND DILUTED LPS TO NON-GAAP ADJUSTED NET INCOME AND DILUTEDEPS GUIDANCE(In millions, except per share amounts)(Unaudited) Net Income(Loss) DilutedEPS/(LPS) GAAP $(615) - $(450) $(10.00) - $(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 expense 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 - 0.15 Non-GAAP adjusted $250 - $350 $4.00 - $5.60 Weighted-average ordinary shares used in per share calculations - GAAP 61 - 62 Weighted-average ordinary shares used in per share calculations - non-GAAP 62 - 63 The Company's 2025 financial guidance includes the anticipated results of the acquired Chimerix operations from the date of acquisition April 21, 2025 and an acquired IPR&D expense as a result of the Company's expected accounting treatment of Chimerix as an asset acquisition. This guidance remains subject to final acquisition accounting. Contacts: Investors: Jeff Macdonald Executive Director, Investor Relations Jazz Pharmaceuticals plc InvestorInfo@jazzpharma.com Ireland +353 1 634 3211 U.S. +1 650 496 2717 Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141 U.S. +1 215 867 4948 View original content to download multimedia:https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-first-quarter-2025-financial-results-and-updates-2025-financial-guidance-302447694.html SOURCE Jazz Pharmaceuticals plc

全球医疗行业每日重点资讯文 | 苏丁企业动态罗氏集团(Roche)周二表示，计划未来五年在美国投资500亿美元，这是迄今为止跨国公司为应对特朗普关税政策而宣布的在美国的最大的投资举措之一。这家瑞士制药巨头表示，这项投资将创造超过12000个新工作岗位，其中包括近6500个建筑工作岗位，以及1000个新建和扩建设施的工作岗位。全球骨科巨头捷迈邦美Zimmer Biomet宣布，已完成对Paragon 28的收购，该交易价值12亿美元。Paragon 28拥有广泛的手术产品和系统，涵盖足部和踝部所有主要领域，包括骨折和创伤、畸形矫正以及关节置换。全球足踝骨科市场估计为50亿美元，并且正在迅速增长。通过收购Paragon 28，捷迈邦美获得了进入这一专业领域的机会，使其产品组合多样化，超越了髋关节、膝关节和脊柱等传统骨科。Jazz Pharmaceuticals plc 宣布以约9.35亿美元的现金成功完成对Chimerix，Inc. 的收购。Chimerix现在是Jazz的全资子公司。将Chimerix引入为Jazz的肿瘤产品组合增添了一种新型药物。Dordaviprone 可能成为第一个也是唯一一个获得FDA批准的H3 K27M 突变弥漫性神经胶质瘤患者的疗法，如果获得批准，将提供有前途的近期商业机会。瑞典生物技术公司Biotage宣布，KKR Funds间接全资拥有的新成立公司RWK BidCo AB以每股145瑞典克朗的价格提出现金收购要约，收购金额达116亿瑞典克朗（约合12亿美元）。声明称，Biotage董事会建议股东接受该收购要约。华兰股份与甘李药业签订战略合作协议，结成长期友好的战略合作伙伴，初始期限为3年。其中，在初始期限内，甘李药业拟向华兰股份采购笔式注射器用溴化丁基橡胶活塞2亿支，此数量仅为预测数量，不具有约束力承诺。具体采购价格、订单数量以实际下达订单为准。上海交通大学医学院附属仁济医院与蚂蚁集团已打造全国首个泌尿专科智能体，该智能体采用上海仁济医院97.6%疾病谱的标准化病例数据集，以及20多个专科医生撰写的场景疾病知识图谱，将三甲医院诊疗逻辑与AI技术结合。产业动态仿制药行业警告称，美国对药品征收关税可能导致包括癌症治疗在内的药品短缺，制造商可能会停止生产因此变得无利可图的产品。仿制药是不再受专利保护的药品的廉价版本，约占美国药品供应的90%。大多数是在美国以外的印度等低成本国家制造的。产品中使用的活性成分通常来自中国。到目前为止，药品尚未受到美国大范围新关税的影响。但美国总统特朗普一再表示，他计划对该行业征收关税，美国商务部也表示正在调查药品进口对国家安全的影响。诺和诺德宣布已向美国FDA提交口服版GLP-1减肥药物的上市申请。这款药物是其注射型减肥针Wegovy（司美格鲁肽）的口服版本，距离2023年5月公布关键3期临床试验成功结果已过去近两年。根据试验数据，口服司美格鲁肽最高剂量（50mg）组患者在64周内体重减轻15%。礼来首席执行官David Ricks表示，礼来将在美国生产其研究性口服肥胖药物Orforglipron。他补充说，如果获得批准，礼来将能够在全球范围内大规模推出Orforglipron，而不会因潜在的美国新关税而导致供应中断。礼来将在今年年底前将其提交给FDA，并在2026年推出。阿斯利康宣布，长效C5补体抑制剂伟立瑞（瑞利珠单抗注射液）在中国正式获批与常规治疗药物联合用于治疗抗乙酰胆碱受体（AChR）抗体阳性的成人全身型重症肌无力（gMG）患者。目前，瑞利珠单抗已在美国、欧盟、日本等国家和地区获批用于治疗抗AChR抗体阳性的gMG成人患者，并在全球多个国家和地区获批多项适应症。阿斯利康宣布，中国国家药品监督管理局于2025年4月15日正式批准荃科得（卡匹色替片）联合氟维司群用于转移性阶段至少接受过一种内分泌治疗后疾病进展，或在辅助治疗期间或完成辅助治疗后12个月内复发的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性且伴有一种或多种PIK3CA/AKT1/PTEN改变的局部晚期或转移性乳腺癌成人患者。百时美施贵宝宣布，PD-1抑制剂欧狄沃（纳武利尤单抗注射液）获得中国国家药品监督管理局（NMPA）批准新增适应症：联合含铂化疗作为新辅助治疗，术后继续以欧狄沃作为单药辅助治疗，用于治疗可手术切除的Ⅱ、ⅢA和ⅢB期且无已知表皮生长因子受体（EGFR）突变或间变性淋巴瘤激酶（ALK）重排的成人非小细胞肺癌（NSCLC）患者。该获批基于CheckMate-77T研究，这是继CheckMate-816后，又一项证实欧狄沃方案用于可切除非小细胞肺癌，可带来显著获益的III期研究。上海医药公告，下属子公司上海上药中西制药有限公司收到美国食品药品监督管理局的通知，其盐酸缬更昔洛韦片的简略新药申请已获得批准。该药品主要用于治疗成人获得性免疫缺陷综合症患者的巨细胞病毒视网膜炎，并预防存在CMV感染风险的实体器官移植患者的CMV感染。亚盛医药宣布，公司自主研发的两款创新药均获纳入2025年中国临床肿瘤学会（CSCO）系列指南：在研品种新型口服Bcl-2选择性抑制剂Lisaftoclax（APG-2575）首次获《CSCO淋巴瘤诊疗指南》推荐。公司原创1类新药、新一代酪氨酸激酶抑制剂（TKI）奥雷巴替尼片（商品名：耐立克）获《CSCO儿童及青少年白血病诊疗指南》升级推荐；延续《CSCO恶性血液病诊疗指南》相关推荐。Gene Solutions宣布在《JCO Oncology Advances》发表了一项开创性的真实世界研究成果，验证了ctDNA是一种强有力的预后生物标志物，可在癌症管理期间有效监测患者。K-TRACK是一项基于循环肿瘤DNA（ctDNA）技术的突破性检测，旨在提供价格可及的肿瘤基因图谱分析和个性化癌症监测。这项研究是亚洲同类研究中的首例，验证了K-TRACK在癌症早期及晚期阶段均具有重要的临床价值。联系美通社+86-10-5953 9500info@prnasia.com