Jazz Pharmaceuticals JAZZ - オプションチェーン

Jazz Pharmaceuticals PLC ([symbol]) オプションチェーン

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行使価格	買値	売値	前回の価格	中間価格	前日比	前日比 %	出来高	建玉	最終取引
170.00	68.00	71.70	62.00	69.85	0.00	0.00 %	0	27	-
175.00	63.00	66.70	28.15	64.85	0.00	0.00 %	0	10	-
180.00	58.00	61.60	49.30	59.80	0.00	0.00 %	0	19	-
185.00	53.00	56.60	57.50	54.80	0.00	0.00 %	0	38	-
190.00	48.10	52.00	18.50	50.05	0.00	0.00 %	0	117	-
195.00	43.10	47.10	47.60	45.10	0.00	0.00 %	0	20	-
200.00	38.50	41.90	33.95	40.20	0.00	0.00 %	0	22	-
210.00	28.50	32.20	21.10	30.35	0.00	0.00 %	0	174	-
220.00	19.10	22.50	20.84	20.80	9.99	92.07 %	5	260	2026/6/05
230.00	10.80	13.90	9.49	12.35	3.19	50.63 %	2	107	2026/6/04
240.00	4.70	8.50	6.20	6.60	2.75	79.71 %	12	178	2026/6/05
250.00	1.00	4.60	2.00	2.80	0.00	0.00 %	0	70	-
260.00	0.05	4.10	2.14	2.075	0.00	0.00 %	0	9	-
270.00	0.05	1.45	0.70	0.75	0.00	0.00 %	0	11	-
280.00	0.00	2.90	0.00	0.00	0.00	0.00 %	0	0	-
290.00	0.00	3.50	0.00	0.00	0.00	0.00 %	0	0	-

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行使価格	買値	売値	前回の価格	中間価格	前日比	前日比 %	出来高	建玉	最終取引
170.00	0.00	3.40	5.22	5.22	0.00	0.00 %	0	524	-
175.00	0.00	3.40	1.33	1.33	0.00	0.00 %	0	51	-
180.00	0.00	3.40	19.00	19.00	0.00	0.00 %	0	12	-
185.00	0.00	3.40	18.80	18.80	0.00	0.00 %	0	2	-
190.00	0.00	3.30	4.50	4.50	0.00	0.00 %	0	7	-
195.00	0.00	3.40	0.00	0.00	0.00	0.00 %	0	0	-
200.00	0.00	3.50	0.34	0.34	0.00	0.00 %	0	25	-
210.00	0.15	3.60	0.79	1.875	0.00	0.00 %	0	12	-
220.00	1.35	3.90	4.00	2.625	0.00	0.00 %	0	91	-
230.00	1.80	3.60	6.20	2.70	0.00	0.00 %	0	122	-
240.00	5.30	8.60	7.33	6.95	-3.67	-33.36 %	6	29	2026/6/05
250.00	11.30	14.90	12.16	13.10	0.00	0.00 %	0	1	-
260.00	19.40	23.00	0.00	21.20	0.00	0.00 %	0	0	-
270.00	28.30	32.30	0.00	30.30	0.00	0.00 %	0	0	-
280.00	38.20	42.00	0.00	40.10	0.00	0.00 %	0	0	-
290.00	48.40	52.00	0.00	50.20	0.00	0.00 %	0	0	-

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銘柄コード

株価

出来高

CXAICXApp Inc

US$ 0.2565

(61.12%)

538.18M

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US$ 0.162699

(10.75%)

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US$ 218.66

(1.82%)

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US$ 0.0366

(-32.22%)

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US$ 0.2009

(-69.07%)

141.61M

Jazz Pharmaceuticals Announces First Quarter 2026 Financial ResultsMay 5, 2026 4:05 PM
PR Newswire (US) – Strong commercial execution across franchises with total revenues of $1.1 billion (+19% YoY) –– Zanidatamab HER2+ 1L GEA sBLA granted Priority Review; PDUFA date of August 25, 2026 –– Xywav® revenues grew 18% YoY with 425 net patient adds –– Epidiolex® revenues grew 15% YoY–– Company reaffirms 2026 revenue and expense guidance –DUBLIN, May 5, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2026 (1Q26)."Our first-quarter results reflect disciplined execution across the business, delivering 19% year-over-year growth alongside key pipeline advancements and positioning the company for an outstanding 2026," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "Demand for Xywav remained strong, our rare oncology launches with Modeyso™ and Zepzelca® in 1LM ES-SCLC gained significant momentum, and Epidiolex continued to provide consistent growth. Looking ahead, we are excited about the potential launch of zanidatamab in 1L GEA later this year, as we progress our pipeline and business development efforts to bring more life-changing therapies to patients and fuel durable long-term growth."Key First Quarter 2026 HighlightsTotal revenues in 1Q26 grew to $1.1 billion (+19% year-over-year (YoY))Generated GAAP / non-GAAP1 adjusted earnings per share (EPS) of $4.43 / $6.34 with $408 million in cash from operations.Practice-changing Phase 3 HERIZON-GEA-01 results, presented as a late-breaker at ASCO GI, support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L advanced gastroesophageal adenocarcinoma (GEA); additional benefit from tislelizumab irrespective of PD-L1 status.Supplemental Biologics License Application (sBLA) accepted by FDA under Real-Time Oncology Review (RTOR) program with potential approval and launch in 1L HER2+ GEA on or before PDUFA date.Business UpdatesXywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:Xywav net product sales increased 18% to $408 million in 1Q26, compared to 1Q25.Continued physician and patient demand for the differentiated benefits of low-sodium Xywav.Strong new patient growth, with approximately 425 net patient adds in 1Q26. There were approximately 16,600 active patients exiting the quarter, comprised of approximately 11,075 narcolepsy patients and approximately 5,525 idiopathic hypersomnia (IH) patients.________________________________1 Non-GAAP adjusted EPS is a non-GAAP financial measure. See 'Non-GAAP Financial Measures' below for more information. A reconciliation of GAAP reported EPS to non-GAAP adjusted EPS is included at the end of this press release.Epidiolex/Epidyolex (cannabidiol):Epidiolex/Epidyolex net product sales increased 15% YoY to $250 million in 1Q26, driven by continued strong demand.Announced agreement with Nippon Zoki to commercialize Epidyolex in Japan, following completion of ongoing clinical trials and potential regulatory approval.Ziihera® (zanidatamab-hrii):Ziihera net product sales in biliary tract cancer (BTC) were $13 million in 1Q26.In April 2026, FDA accepted the zanidatamab sBLA in GEA for a Priority Review, with a PDUFA date of August 25, 2026.Submitted HERIZON-GEA-01 data for potential National Comprehensive Cancer Network (NCCN) guideline inclusion.HERIZON-GEA-01 data accepted for publication by a top-tier medical journal.The second interim overall survival (OS) analysis for the HERIZON-GEA-01 trial doublet regimen is expected in mid-2026.Multiple registrational trials of zanidatamab are underway, including in metastatic breast cancer (mBC), supporting a broad development program designed to maximize patient impact and long-term shareholder value.Modeyso (dordaviprone):Modeyso net product sales were $41 million in 1Q26 with ~500 patients having received Modeyso from product launch in August 2025 through the end of the first quarter.The company completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $200 million (50% to Jazz).Phase 3 ACTION trial remains on track with top-line readout expected late 2026 / early 2027.Zepzelca (lurbinectedin):Zepzelca net product sales increased 60% YoY to $101 million in 1Q26, driven by continued uptake of the Zepzelca and atezolizumab combination in the 1LM ES-SCLC setting, partially offset by a decline in second line use.The company expects second line use to decline throughout the year.Financial Highlights
Three Months EndedMarch 31,(In millions, except per share amounts)2026
2025Total revenues$      1,068.9
$        897.8GAAP net income (loss)$        293.1
$        (92.5)Non-GAAP adjusted net income$        419.5
$        105.2GAAP earnings (loss) per share$          4.43
$        (1.52)Non-GAAP adjusted earnings per share$          6.34
$          1.68The GAAP net loss and non-GAAP adjusted net income for 1Q25 included an expense of $172 million related to Xyrem antitrust litigation settlements, which impacted our GAAP and non-GAAP results by $146 million (net of tax of $26 million), or $2.38 per share on a GAAP basis and $2.34 per share on a non-GAAP adjusted basis.Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.Total Revenues
Three Months EndedMarch 31,(In millions)2026
2025Xywav$        408.2
$        344.8Xyrem31.2
37.2Sleep439.4
382.0Epidiolex/Epidyolex249.8
217.7Epilepsy249.8
217.7Rylaze/Enrylaze103.7
94.2Zepzelca101.0
63.0Defitelio/defibrotide 47.4
40.7Modeyso41.4
—Vyxeos26.6
29.5Ziihera13.3
2.0Oncology333.4
229.4Other2.7
10.3Product sales, net1,025.3
839.4High-sodium oxybate AG royalty revenue36.3
48.9Other royalty and contract revenues7.3
9.5Total revenues$      1,068.9
$        897.8Total revenues increased 19% YoY primarily due to higher Xywav, Zepzelca and Epidiolex/Epidyolex net product sales and the inclusion of Modeyso net product sales, following FDA approval in August 2025.Operating Expenses and Income Tax Expense (Benefit)
Three Months EndedMarch 31,(In millions, except percentages)2026
2025GAAP:

Cost of product sales$       134.1
$       104.6Gross margin on total revenues87.5 %
88.3 %Selling, general and administrative$       352.7
$       514.0% of total revenues33.0 %
57.3 %Research and development$       196.0
$       180.7% of total revenues18.3 %
20.1 %Gain on sale of priority review voucher$     (122.8)
$            —Income tax expense (benefit) $          6.1
$       (17.8)Effective tax rate2.0 %
16.2 %

Three Months EndedMarch 31,(In millions, except percentages)2026
2025Non-GAAP adjusted:

Cost of product sales$         90.0
$         69.7Gross margin on total revenues 91.6 %
92.2 %Selling, general and administrative$       308.5
$       472.3% of total revenues28.9 %
52.6 %Research and development$       172.3
$       159.7% of total revenues16.1 %
17.8 %Income tax expense$         41.2
$         36.5Effective tax rate8.9 %
25.7 %Changes in operating expenses and income tax expense (benefit) in 1Q26 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 1Q26, primarily due to higher royalty expenses, driven by higher revenues, and increased inventory provisions. The cost of product sales, on a GAAP basis, in 1Q26 included higher acquisition accounting inventory fair value step up expense compared to 1Q25.Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 1Q26, primarily due to certain Xyrem antitrust litigation settlements of $172 million incurred in 1Q25, partially offset by higher compensation-related expenses in 1Q26 including costs relating to Modeyso.Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, increased in 1Q26, primarily due to the addition of costs relating to Modeyso including personnel costs.Income tax expense in 1Q26, on a GAAP basis, was primarily attributable to the gain recognized on the sale of the PRV, partially offset by excess tax benefits from share-based compensation. Income tax benefit in 1Q25, on a GAAP basis, was primarily attributable to the Xyrem antitrust litigation settlements. Cash Flow and Balance Sheet As of March 31, 2026, cash, cash equivalents and investments were $2.9 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 million. For the three months ended March 31, 2026, the company generated $408 million of cash from operations reflecting strong business performance and continued financial discipline. In 1Q26, the company received gross proceeds of $200 million (50% to Jazz) from the sale of the PRV.2026 Financial Guidance (In millions)

GuidanceTotal Revenues

$4,250 - $4,500

(In millions, except percentages)GAAP
Non-GAAPGross margin %89% - 90%
90% - 91%1SG&A expenses$1,424 - $1,497
$1,260 - $1,3201R&D expenses$811 - $867
$725 - $7751Effective tax rate0% - 10%
11.5% - 13.5%1Weighted-average ordinary shares outstanding266 - 67
66 - 67___________________________1.See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included in the table titled "Reconciliation of 2026 GAAP to Non-GAAP Guidance Measures".2.Prior guidance as of February 24, 2026 was 65-66 million weighted-average ordinary shares outstanding. Guidance assumes inclusion of shares outstanding in relation to the 2.000% exchangeable senior notes due 2026 and the 3.125% exchangeable senior notes due 2030, which we refer to collectively as the Exchangeable Senior Notes, given the company's share price exceeds the conversion prices of the Exchangeable Senior Notes.Conference Call DetailsJazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET to provide a business and financial update and discuss its 2026 first quarter results.Interested parties may register for the call here or 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 PharmaceuticalsJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharma 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 rare disease — often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics. 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 MeasuresTo 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 income (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. 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.Cautionary Note Concerning Forward-Looking StatementsThis 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 2026 financial guidance and the company's expectations related thereto, including with respect to anticipated catalysts; the company's advancement of pipeline programs and the timing of development activities, regulatory activities, approvals, and submissions related thereto; the potential for a near-term commercial launch of zanidatamab in 1L HER2+ GEA in the U.S., if approved; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: the second interim OS data from the Phase 3 HERIZON trial of zanidatamab in 1L GEA and top-line data from the Phase 3 ACTION trial of Modeyso in recurrent H3 K27M-mutant diffuse glioma; 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 zanidatamab's potential to become the HER2-targeted therapy of choice in 1L HER2+ GEA, regardless of PD-L1 status; 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, including the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of Modeyso in recurrent H3 K27M-mutant diffuse glioma and extend to use in 1L patients; 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, Epidiolex/Epidyolex, Ziihera, Modeyso, Zepzelca and other lead marketed products; 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, including the risk that zanidatamab in 1L HER2+ GEA may not be approved in a timely manner or at all; the costly and time-consuming pharmaceutical product development process 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; 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; delays or problems in the supply or manufacture of the company's products and product candidates, including due to geopolitical tensions and military conflicts; 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 products, product candidates and businesses; the company's ability to realize the anticipated benefits of 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; and other risks and uncertainties affecting the company, including those described from time to time under the caption "Risk Factors" and elsewhere in the company's Securities and Exchange Commission filings and reports, including the company's Annual Report on Form 10-K for the year ended December 31, 2025 and future filings and reports by the company. 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 PLCCONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)(In millions, except per share amounts)(Unaudited)

Three Months EndedMarch 31,
2026
2025Revenues:

Product sales, net$      1,025.3
$         839.4Royalties and contract revenues43.6
58.4Total revenues1,068.9
897.8Operating expenses:

Cost of product sales (excluding amortization of acquired developed technologies)134.1
104.6Selling, general and administrative352.7
514.0Research and development196.0
180.7Intangible asset amortization172.3
154.4Gain on sale of priority review voucher(122.8)
—Total operating expenses732.3
953.7Income (loss) from operations336.6
(55.9)Interest expense, net(39.9)
(53.7)Foreign exchange gain (loss)2.5
(0.2)Income (loss) before income tax expense (benefit) and equity in loss of investees299.2
(109.8)Income tax expense (benefit) 6.1
(17.8)Equity in loss of investees—
0.5Net income (loss)$         293.1
$         (92.5)

Net income (loss) per ordinary share:

Basic $          4.73
$         (1.52)Diluted$          4.43
$         (1.52)Weighted-average ordinary shares used in per share calculations - basic61.9
61.0Weighted-average ordinary shares used in per share calculations - diluted66.1
61.0 JAZZ PHARMACEUTICALS PLCCONDENSED CONSOLIDATED BALANCE SHEETS(In millions)(Unaudited)

March 31,
2026
December 31,
2025ASSETS

Current assets:

Cash and cash equivalents$        1,844.3
$       1,391.9Investments1,030.0
1,050.0Accounts receivable, net of allowances836.3
830.7Inventories437.5
417.0Prepaid expenses149.7
152.5Other current assets285.3
323.9Total current assets4,583.1
4,166.0Property, plant and equipment, net203.1
199.9Operating lease assets55.8
58.9Intangible assets, net4,203.8
4,429.5Goodwill1,805.0
1,829.3Deferred tax assets, net907.0
869.1Deferred financing costs7.1
7.6Other non-current assets94.7
99.0Total assets$      11,859.6
$      11,659.3LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:

Accounts payable$          100.0
$          122.1Accrued liabilities1,022.4
1,034.2Current portion of long-term debt1,030.5
1,029.9Income taxes payable93.7
56.3Total current liabilities2,246.6
2,242.5Long-term debt, less current portion4,324.2
4,328.4Operating lease liabilities, less current portion47.3
50.9Deferred tax liabilities, net547.7
594.5Other non-current liabilities161.5
124.4Total shareholders' equity4,532.3
4,318.6Total liabilities and shareholders' equity$      11,859.6
$      11,659.3 JAZZ PHARMACEUTICALS PLCSUMMARY OF CASH FLOWS (In millions)(Unaudited)

Three Months EndedMarch 31,
2026
2025Net cash provided by operating activities$          408.2
$          429.8Net cash provided by (used in) investing activities123.1
(169.0)Net cash used in financing activities(78.5)
(813.5)Effect of exchange rates on cash and cash equivalents(0.4)
1.7Net increase (decrease) in cash and cash equivalents$          452.4
$         (551.0) JAZZ PHARMACEUTICALS PLCRECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION(In millions, except per share amounts)(Unaudited)

Three Months EndedMarch 31,
2026
2025
Net
Income
Diluted
EPS
Net Income
(Loss)
Diluted
EPS/(Loss
Per Share)GAAP reported$     293.1
$       4.43
$     (92.5)
$       (1.52)Intangible asset amortization172.3
2.61
154.4
2.47Share-based compensation expense74.5
1.13
67.7
1.08Acquisition accounting inventory fair value step-up37.5
0.57
29.9
0.48Gain on sale of PRV(122.8)
(1.86)
—
—Income tax effect of above adjustments(35.1)
(0.54)
(54.3)
(0.87)Effect of potentially dilutive ordinary shares on non-GAAP adjusted EPS—
—
—
0.04Non-GAAP adjusted$     419.5
$       6.34
$     105.2
$        1.68Weighted-average ordinary shares used in diluted per share calculations - GAAP66.1

61.0

Dilutive effect of employee equity incentive and purchase plans—

1.6

Weighted-average ordinary shares used in diluted per share calculations - non-GAAP66.1

62.6

JAZZ PHARMACEUTICALS PLCRECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION - CERTAIN LINE ITEMS(In millions, except percentages)(Unaudited)

Three months ended March 31, 2026
Cost of
product
sales
Gross
margin
SG&A
R&D
Intangible
asset
amortization
Gain on
sale
of PRV
Interest
expense,
net
Income tax
expense
Effective
tax rateGAAP Reported$  134.1
87.5 %
$  352.7
$  196.0
$    172.3
$ (122.8)
$   39.9
$     6.1
2.0 %Non-GAAP Adjustments:

Intangible asset amortization—
—
—
—
(172.3)
—
—
—
—Share-based compensation expense(6.6)
0.6
(44.2)
(23.7)
—
—
—
—
—Acquisition accounting inventory fair value step-up(37.5)
3.5
—
—
—
—
—
—
—Gain on sale of PRV—
—
—
—
—
122.8
—
—
—Income tax effect of above adjustments—
—
—
—
—
—
—
35.1
6.9Total of non-GAAP adjustments(44.1)
4.1
(44.2)
(23.7)
(172.3)
122.8
—
35.1
6.9Non-GAAP Adjusted$    90.0
91.6 %
$  308.5
$  172.3
$       —
$      —
$   39.9
$    41.2
8.9 %
Three months ended March 31, 2025
Cost of
product
sales
Gross
margin
SG&A
R&D
Intangible
asset
amortization
Interest
expense,
net
Income tax
expense
(benefit)
Effective
tax rateGAAP Reported$   104.6
88.3 %
$      514.0
$    180.7
$   154.4
$     53.7
$   (17.8)
16.2 %Non-GAAP Adjustments:

Intangible asset amortization—
—
—
—
(154.4)
—
—
—Share-based compensation expense(5.0)
0.6
(41.7)
(21.0)
—
—
—
—Acquisition accounting inventory fair value step-up(29.9)
3.3
—
—
—
—
—
—Income tax effect of above adjustments—
—
—
—
—
—
54.3
9.5Total of non-GAAP adjustments(34.9)
3.9
(41.7)
(21.0)
(154.4)
—
54.3
9.5Non-GAAP Adjusted$     69.7
92.2 %
$      472.3
$    159.7
$       —
$     53.7
$    36.5
25.7 % JAZZ PHARMACEUTICALS PLCRECONCILIATION OF 2026 GAAP TO NON-GAAP GUIDANCE MEASURES

Projected Range(In millions, except percentages)Low
HighGAAP gross margin on total revenues89 %
90 %Acquisition accounting inventory fair value step-up1 %
1 %Non-GAAP gross margin on total revenues90 %
91 %

GAAP SG&A expenses$               1,424
$               1,497Share-based compensation expense(164)
(177)Non-GAAP SG&A expenses$               1,260
$               1,320

GAAP R&D expenses$                 811
$                 867Share-based compensation expense(86)
(92)Non-GAAP R&D expenses$                 725
$                 775

GAAP effective tax rate 0 %
10 %Income tax effect of GAAP to non-GAAP reconciling items11.5 %
3.5 %Non-GAAP effective tax rate11.5 %
13.5 %Contacts:Investors:
InvestorInfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717Media:
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-2026-financial-results-302763061.htmlSOURCE Jazz Pharmaceuticals plc Original: Jazz Pharmaceuticals Announces First Quarter 2026 Financial Results

Jazz Pharmaceuticals to Present Research on Epidiolex® (cannabidiol) and Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution at the 2026 American Academy of Neurology Annual MeetingApril 9, 2026 7:45 AM
PR Newswire (US)

Six abstracts, including one oral presentation, underscore Jazz's ongoing commitment to generating real-
world evidence addressing rare neurological disorders, including rare and severe forms of epilepsy and
sleep disordersFor U.S. media and investors onlyDUBLIN, April 9, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company will present six abstracts, including one oral presentation, at the 2026 American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026, in Chicago.The research demonstrates the breadth of Jazz's neuroscience portfolio spanning epilepsy and sleep disorders, with new clinical data evaluating Epidiolex® (cannabidiol) in patients with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC), or other refractory epilepsies; and Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution in patients with narcolepsy."Jazz is proud to present research at another AAN Annual Meeting, especially as we continue to sharpen our focus on the significant unmet needs faced by people with rare neurological disorders, including epilepsy and sleep disorders," said Jessa Alexander, Ph.D., neuroscience therapeutic area head, global medical and scientific affairs of Jazz Pharmaceuticals. "Through our ongoing Epidiolex and Xywav research, we are gaining a deeper understanding of these complex conditions, and the real treatment needs patients experience, with data that enriches our view of the patient journey and focuses our R&D efforts on closing persistent gaps in care across rare neurology."Highlights at the 2026 AAN Annual Meeting include:An oral presentation showcasing results from the prespecified 6-month intermediate analysis of the ongoing EpiCom Phase 3b/4 study demonstrated reductions in the severity of caregiver- and clinician-reported behavioral problems at 26 weeks after Epidiolex treatment initiation in patients with TSC-associated seizures. Improvements were seen across the TSC-Associated Neuropsychiatric Disorders Self-Report Quantified Checklist (TAND-SQ), Aberrant Behavior Checklist (ABC) subscale scores and Caregiver- and Clinician-Global Impression of Severity (CGI-S) scales.A poster presentation detailing sociodemographic and clinical factors associated with persistence on Epidiolex among patients with LGS, DS, TSC, or other refractory epilepsies, based on claims analysis. This analysis of over 7,800 patients demonstrates how care variability in a non-standardized and fragmented care environment like epilepsy sheds light on the key factors that may influence whether patients remain on treatment and may help clinicians support treatment continuity.A poster presentation featuring an analysis of adults with narcolepsy from the open-label, single-arm DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) study evaluating changes in cognitive complaints, daily functioning, work productivity and overall disease burden in patients treated with Xywav dosages >9 grams per night. Improvements in these outcomes were observed in participants who optimized their Xywav dosage to >9 grams per night (up to 12 grams total) when compared to a 9 gram per night dosage. The current recommended dosage of Xywav for adults with narcolepsy is 6-9 grams per night.The 2026 AAN Annual Meeting abstracts are available online at: https://index.mirasmart.com/AAN2026/.The full list of Jazz's presentations are:Presentation TitleAuthorsPresentation DetailsEpidiolex PresentationsTuberous Sclerosis Complex
(TSC)–Associated Neuropsychiatric
Disorders (TAND) Outcomes
Following Adjunctive Cannabidiol
(CBD) Treatment: 6-Month
Intermediate Analysis of the
EpiCom TrialAgnies van Eeghen, Sarah
M.L. Wilson, Elizabeth A.
Thiele, Stevie Roszkowski,
Maria Dunaway-Bryant,
Kasia Wajer, Teresa Greco,
Joanne Stevens, Lisa
Moore-Ramdin, Petrus J.
de Vries Type: Oral PresentationSession: S5: Clinical EpilepsyDate/Time: Sunday, April 19 at
1:48 p.m. CTPresentation Number: 005An Assessment of Acute
Pharmacodynamic Drug-Drug
Interactions (PD-DDIs) Between
Cannabidiol (CBD) and
Cenobamate (CNB) in a Mouse
Model of Generalized Tonic
Seizures Rohini R. Rana, William H.
Hind, Pabitra H. Patra,
Saga Johansson, Karthik
Rajasekaran, H. Steve
White, David J. Virley Type: PosterSession: P3 Epilepsy/Clinical
Neurophysiology (EEG): Anti-
seizure Medications: Mechanisms
and PharmacologyDate/Time: Sunday, April 19,
5-6 p.m. CT Abstract Number: 001Demographics and Clinical Factors
Associated With Persistence on
Cannabidiol (CBD) in US Patients
With Lennox-Gastaut Syndrome
(LGS), Dravet Syndrome (DS),
Tuberous Sclerosis Complex
(TSC), or Other Refractory
Epilepsies Leah Burn, Vicki Osborne,
Arthur Sillah, Timothy
Saurer, Michael Faithe,
Maggie McCarter, Sanket
Shah, Timothy Barnes,
Arunima Sachdev, Anuj
Gupta, Mohankumar
Kurukumbi Type: PosterSession: P10 Epilepsy/Clinical
Neurophysiology (EEG): Epilepsy
Syndromes and GeneticsDate/Time: Wednesday, April 22,
8-9 a.m. CTAbstract Number: 004Cannabidiol Efficacy in Patients
With Lennox-Gastaut Syndrome
With Developmental and Epileptic
Encephalopathy-Associated
Genetic Variants: A Subgroup
Analysis Elizabeth A. Thiele, Michael
Boffa, Daniel Checketts,
Farhad Sahebkar
Type: PosterSession: P10 Epilepsy/Clinical
Neurophysiology (EEG): Epilepsy
Syndromes and GeneticsDate/Time: Wednesday, April 22,
8-9 a.m. CTAbstract Number: 008Phase 1, Open-Label, Fixed-
Sequence, Bidirectional,
Pharmacokinetic (PK) Drug-Drug
Interaction (DDI) Study Between
Cannabidiol (CBD) and
Cenobamate (CNB) in Healthy
Adult Participants
Arjun Vijan, Hongwei Xue,
Patricia Chandler, Sujith
Madhavan, Cuiping Chen Type: PosterSession: P11 Epilepsy/Clinical
Neurophysiology (EEG): Anti-
seizure Medications: Clinical
TrialsDate/Time: Wednesday, April 22,
11:45 a.m. - 12:45 p.m. CTAbstract Number: 002Xywav PresentationChanges in Self-Reported Cognitive
Complaints, Functional
Impairments, Work Productivity,
and Symptom Severity in
Participants With Narcolepsy After
Treatment With Greater Than 9
Gram Dosages of Low-Sodium
Oxybate in the DUET StudyLogan Schneider, Chad
Ruoff, David Plante, Jerald
H. Simmons, Deborah A.
Nichols, Teresa Steininger,
Marisa Whalen, Jing Dai,
Alyssa Cairns, Richard K.
BoganType: PosterSession: P3: Sleep:
PathophysiologyDate/Time: Sunday, April 19,
5-6 p.m. CTAbstract Number: 003About Epidiolex®/Epidyolex® (cannabidiol)
Epidiolex/Epidyolex is a prescription, plant-derived cannabis-based medicine administered as an oral solution which contains highly purified cannabidiol (CBD). Cannabidiol, the active ingredient in Epidiolex, is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. The precise mechanisms by which Epidiolex exerts its anticonvulsant effect in humans are unknown. Epidiolex has been approved for use by healthcare regulatory authorities in the U.S., Europe, Great Britain, Canada, Australia, Switzerland, Taiwan, Israel, and New Zealand, among other countries. In the U.S., Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex has received approval in the European Union under the tradename Epidyolex for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and DS in patients two years and older, and for adjunctive use to treat seizures associated with TSC, in patients two years of age and older. Epidiolex has received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of seizures associated with LGS, DS, and TSC. Similarly, Epidyolex received ODD from the European Medicines Agency (EMA) for the same indications. Epidiolex is also being studied in additional forms of epilepsy, including the EpiFOS exploratory study (NCT07233239) in focal-onset seizures.Important Safety Information & Indications CONTRAINDICATION: HYPERSENSITIVITY EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product.WARNINGS & PRECAUTIONS Hepatic Injury:
EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Obtain transaminase and bilirubin levels prior to starting treatment, at 1, 3, and 6 months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury. There have been postmarketing reports of cholestatic or mixed patterns of liver injury. Elevated ammonia levels were reported in some patients with transaminase elevations; most taking concomitant valproate, clobazam, or both. Consider discontinuation or dose adjustment of valproate or clobazam if ammonia is elevated.Somnolence and Sedation:
EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants.Suicidal Behavior and Ideation:
Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise them to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness.Withdrawal of Antiepileptic Drugs:
As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.ADVERSE REACTIONS:
The most common adverse reactions in patients receiving EPIDIOLEX (≥10% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed.PREGNANCY:
EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the EPIDIOLEX Pregnancy Surveillance Program and the North American Antiepileptic Drug (NAAED) Pregnancy Registry.DRUG INTERACTIONS:
Strong inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates (see full Prescribing Information). Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX. A lower starting dose of everolimus is recommended when added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary.INDICATIONS:
EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.Please read the EPIDIOLEX full Prescribing Information for additional important information here. About Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution
Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem® (sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. Xywav has 131 mg of sodium at the maximum recommended nightly dose whereas other high sodium oxybates have 1640 mg at the equivalent dose. Xywav is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night at the recommended dose range of 6 g to 9 g/night. Xywav is the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake.Xywav is also the first and only U.S. FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of idiopathic hypersomnia in adults. Xywav is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as EDS, sleep inertia (severe grogginess or confusion when waking up), long sleep duration and cognitive impairment. Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.The exact mechanism of action of Xywav in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of Xywav are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.1 The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.1,2 Because of the risks of central nervous system (CNS) depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.Important Safety Information for XywavWARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE.Central Nervous System Depression
XYWAV is a CNS depressant. Clinically significant respiratory depression and
obtundation may occur in patients treated with XYWAV at recommended doses. Many
patients who received XYWAV during clinical trials in narcolepsy and idiopathic
hypersomnia were receiving CNS stimulants.
Abuse and Misuse
The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or
misuse of illicit GHB, either alone or in combination with other CNS depressants, is
associated with CNS adverse reactions, including seizure, respiratory depression,
decreases in the level of consciousness, coma, and death.Because of the risks of CNS depression and abuse and misuse, XYWAV is available only
through a restricted program under a REMS called the XYWAV and XYREM REMS.Contraindications
XYWAV is contraindicatedin combination with sedative hypnotics or alcohol andin patients with succinic semialdehyde dehydrogenase deficiency.Warnings and Precautions
Central Nervous System Depression
The concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (e.g., post- or perioperative) is required, interruption of treatment with XYWAV should be considered.After first initiating treatment and until certain that XYWAV does not affect them adversely (e.g., impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking XYWAV. Patients should be queried about CNS depression-related events upon initiation of XYWAV therapy and
periodically thereafter.Abuse and Misuse
XYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known as GHB, a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g., assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.XYWAV and XYREM REMS
Because of the risks of central nervous system depression and abuse and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS.Notable requirements of the XYWAV and XYREM REMS include the following:Healthcare Providers who prescribe XYWAV are specially certifiedXYWAV will be dispensed only by the central pharmacy that is specially certifiedXYWAV will be dispensed and shipped only to patients who are enrolled in the XYWAV and XYREM REMS with documentation of safe useFurther information is available at www.XYWAVXYREMREMS.com or 1-866-997-3688.Respiratory Depression and Sleep-Disordered Breathing
XYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate and with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and pediatric patients. A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy.Depression and Suicidality
In Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depression and depressed mood were reported in 3% and 4%, respectively, of patients treated with XYWAV. Two patients (1%) discontinued XYWAV because of depression. In most cases, no change in XYWAV treatment was required. In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment.Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders. The emergence of depression in patients treated with XYWAV requires careful and immediate evaluation. Monitor patients for the emergence of increased depressive symptoms and/or suicidality
while taking XYWAV.Other Behavioral or Psychiatric Adverse Reactions
In Study 1, confusion and anxiety occurred in 1% and 5% of patients with narcolepsy treated with XYWAV, respectively. One patient experienced visual hallucinations and confusion after ingesting approximately 9 grams of XYWAV.In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively. One patient experienced visual hallucinations, which led to discontinuation of XYWAV. Other neuropsychiatric reactions reported with oxybate (same active moiety as XYWAV) in adult or pediatric clinical trials and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should be carefully monitored.Parasomnias
Parasomnias can occur in patients taking XYWAV.In Study 1 and Study 2, parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated with XYWAV, respectively. In a clinical trial of XYREM (same active moiety as XYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate (same active moiety as XYWAV) and in postmarketing experience with sodium oxybate.Episodes of sleepwalking should be fully evaluated and appropriate interventions considered.Most Common Adverse Reactions
The most common adverse reactions (occurring in ≥5% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor. In the pediatric clinical trial with XYREM (same active moiety as XYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (≥5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). The overall adverse reaction profile of XYREM in the pediatric clinical trial was similar to that seen in the adult clinical trial program. The safety profile in pediatric patients with XYWAV is expected to be similar to that of adult patients treated with XYWAV and to that of pediatric patients treated with XYREM.Additional Adverse Reactions
Adverse reactions that occurred in 2-