ジャズファーマシューティカルズの適時開示・決算・その他

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

現行レポート

セクション13または15に基づいて(d)

1934年の証券取引所法の

報告日（最も古い事象の報告日） 2024年1月8日

ジャズ・ファーマスーティカルズ・パブリック・リミテッド・カンパニー

(チャーターで指定された登録者の正確な名前)

アイルランド

001-33500

98-1032470

(State or Other Jurisdiction

of Incorporation)

(Commission

File No.)

(IRS Employer

Identification No.)

アイルランド、ダブリン4、ウォータールー通り、ウォータールー・エクスチェンジ5階 D04 E5W7

(主要な執行機関の住所（郵便番号を含む)

011-353-1-634-7800

(登録者の電話番号（市外局番を含む)

Form8-Kの提出が、以下の条項のいずれかに基づく登録者の提出義務を同時に満たすことを意図している場合は、以下の該当するチェックボックスをチェックしてください：

☐	証券法に基づく規則425に従った書面によるコミュニケーション（17 cfr 230.425)

☐	取引所法の下でのルール14a-12（17 cfr 240.14a-12）に基づく資料の勧誘。)

☐	取引所法の規則14d-2(b)に基づく開始前のコミュニケーション（17 cfr 240.14d-2(b))

☐	証券取引法の規則13e-4(c)に基づく開始前のコミュニケーション（17 cfr 240.13e-4(c))

法第12条(b)に従って登録された証券：

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

普通株式、1株あたりの額面は0.0001ドル

JAZZ

the nasdaq stock market llc

登録者が1933年証券法規則405（本章230.405節）または1934年証券取引法規則12b-2（本章240.12b-2節）で定義される新興成長企業であるかどうかをチェックマークで示す。

Emerging growth company ☐

新興成長企業の場合、登録者が取引所法第13条(a)に従い提供される新規または改訂された財務会計基準に準拠するための移行期間の延長を利用しないことを選択した場合は、チェックマークで示す。☐

Item 2.02.

営業成績および財政状態。

2024年1月8日、ジャズ・ファーマシューティカルズ・ピーエルシー（以下「当社」）のJ.P.モルガン・ヘルスケア・カンファレンスの会社概要および財務に関する最新情報のプレゼンテーションでは、(i)2023年12月31日に終了する年度の総収益、ニューロサイエンスおよびがん領域の売上高ガイダンスについて、既に発表した範囲を達成するとの当社の予想、(ii)当社の主要な成長ドライバーであるXywav、EpidiolexおよびRylazeについて、合計で2桁の収益成長が見込まれるとの当社の予想が示されました、Xywav、Epidiolex、Rylazeは、2024年に合計で2桁の売上成長率を達成する見込みであること、(iii)2024年12月31日に終了する年度におけるオキシベートナトリウムの高承認ジェネリック医薬品のロイヤリティ収入の成長に関する当社の見込み。本プレゼンテーションのコピーは別紙99.1として添付されている。

本Form 8-Kの本項目2.02に含まれる情報は、1934年証券取引所法（改正後）第18条にいう「提出された」ものとはみなされず、また同法または1933年証券法（改正後）第11条および第12条(a)(2)の適用を受けるものでもありません。本Current Report on Form 8-Kの項目2.02に記載されている情報は、米国証券取引委員会に対する当社の提出書類において、当該提出書類における一般的な組み込み文言の有無にかかわらず、本書の日付の前後を問わず、参照により組み込まれることはありません。

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits


Exhibit Number		Description

99.1		2024年1月8日、Jazz Pharmaceuticals plcによるプレゼンテーションスライド。

104		カバーページインタラクティブデータファイル（inline xbrlドキュメントに埋め込まれています。)

SIGNATURES

1934年証券取引法の要件に従い、登録者は本報告書に正式に権限を付与された署名者により、登録者を代表して署名させた。


ジャズ・ファーマスーティカルズ・パブリック・リミテッド・カンパニー

By:		/s/ Patricia Carr
Name:		Patricia Carr
Title:		プリンシパル・アカウンティング・オフィサー兼暫定プリンシパル・ファイナンシャル・オフィサー

Date: January 8, 2024

EX-99.1 2 d636118dex991.htm EX-99.1 EX-99.1

Exhibit 99.1 January 8, 2024 nd 42 Annual J.P. Morgan Healthcare Conference Innovating to Transform the Lives of Patients and Their Families Caroline ® January 2024 Rylaze patient diagnosed with ALL / LBL

Transforming Lives. Redefining Possibilities. Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements and financial targets, including, but not limited to, statements related to: the Company’s growth prospects and future financial and operating results, including Vision 2025 and expectations related thereto; 2023 revenue guidance and the Company’s expectations related thereto; the Company’s ability to deliver sustainable growth and enhance value; the Company’s commercial expectations, including with respect to revenue diversification, and its expectations for significant growth; the Company’s ability to realize the commercial potential of its products, including the blockbuster potential for Epidiolex, growth opportunities for Rylaze, Epidiolex/Epidyolex and Xywav, the Company's ability to achieve double-digit percentage growth in the combined revenues from Xywav, Epidiolex/Epidyolex and Rylaze/Enrylaze in 2024, the expectation that high sodium oxybate AG revenues will exceed $200 million in 2024, the expectation that Xywav will remain the oxybate of choice in narcolepsy and Zepzelca’s potential approval as a first line therapy; the value and growth potential of its products; the Company’s net product sales, 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; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, and planned or anticipated regulatory submissions and filings; the Company’s expectations with respect to its products and product candidates and the potential of the Company’s products and product candidates, including expectations with respect to zanidatamab’s de-risked, near term opportunity, the potential of zanidatamab to be more than a two billion dollar market opportunity with the potential to raise the standard of care for patients and create long-term value for the Company, and the potential regulatory path related thereto; 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, Zepzelca, Epidiolex / Epidyolex and other key 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; 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 such as those experienced, and expected to be experienced, by the Company; the Company’s failure to realize the expected benefits of its acquisition of GW Pharmaceuticals; 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 its obtaining, maintaining and defending intellectual property protection for its products and product candidates; 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; 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, including as part of Vision 2025, 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; the completion of financial closing procedures, final audit adjustments and other developments that may arise that would cause the Company’s expectations with respect to the Company’s 2023 revenue guidance to differ, perhaps materially, from the financial results that will be reflected in the Company’s audited consolidated financial statements for the fiscal year ended December 31, 2023; 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, 2022 as supplemented by the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and its future filings and reports. Other risks and uncertainties of which the Company is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements made in this presentation are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the Company on its website or otherwise. The Company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. 2 January 2024

Transforming Lives. Redefining Possibilities. 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 presentation. The Company presents non-GAAP adjusted operating margin and projected non-GAAP adjusted operating margin improvement. Non-GAAP adjusted operating margin is calculated as total revenues less non-GAAP adjusted cost of product sales, SG&A expenses and R&D expenses divided by total revenues. Non-GAAP adjusted cost of product sales, SG&A expenses and R&D expenses exclude certain line item components from GAAP reported cost of product sales, SG&A expenses and R&D expenses, as detailed in the non-GAAP adjusted operating margin reconciliation table that follows in the Appendix hereto. Investors should note that reconciliations of certain forward-looking or projected non-GAAP financial measures to their most comparable GAAP financial measures cannot be provided because the Company cannot do so without unreasonable efforts due to the unavailability of information needed to calculate reconciling items and due to the variability, complexity and limited visibility of comparable GAAP measures and the reconciling items that would be excluded from the non-GAAP financial measures in future periods. Likewise, reconciliations of projected non-GAAP adjusted cost of product sales, SG&A and R&D expenses, which are used to calculate projected non-GAAP adjusted operating margin and the related projected percentage improvement from 2021, to projected GAAP cost of product sales, SG&A and R&D expenses is not provided. For example, the non-GAAP adjustment for share-based compensation expense requires additional inputs such as the number and value of awards granted that are not currently ascertainable. Investors should note that the amounts of reconciling items between actual non-GAAP adjusted cost of product sales, SG&A and R&D expenses and actual GAAP cost of product sales, SG&A and R&D expenses could be significant such that actual GAAP cost of product sales, SG&A and R&D expenses would vary significantly from the projected adjusted cost of product sales, SG&A and R&D expenses used to calculate projected non-GAAP adjusted operating margin and the related projected percentage improvement from 2021. 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 and 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. The Company’s 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 the Company’s 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 the Company in this presentation 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. 3 January 2024

Our Purpose is to innovate to transform the lives of patients and their families. Who We Are We are focused on developing life-changing medicines for people with serious diseases, often with limited or no therapeutic options, so they can live their lives more fully. William Kasen and his mom Brittany Xywav patient living with IH Epidiolex patient living with Dravet syndrome IH = idiopathic hypersomnia. 4 January 2024

Jazz in 2024: Multiple near-term growth drivers, significant pipeline catalysts and well-positioned to deliver meaningful value CORPORATE COMMERCIAL PIPELINE DEVELOPMENT Expect double-digit Multiple near-term catalysts Well-positioned to be percentage revenue growth targeting significant market partner of choice, with across combined key growth opportunities financial strength to 1 drivers transact Initiated zanidatamab BLA submission Note: near-term growth drivers and pipeline catalysts are anticipated based on expectations for 2024; for further information, please see ”Caution Concerning Forward-Looking Statements”.; 1 5 January 2024 BLA = biologics license application. Key growth drivers include: Xywav, Epidiolex, Rylaze.

Growth & Execution Driving Growth and Delivering Value Through Continued Execution 6 January 2024

GROWTH & EXECUTION PIPELINE COMMERCIAL Consistent Growth Driving Long-Term Shareholder Value Expect to meet 2023 total, neuroscience and $3.75 – 1 oncology revenue guidance 1 $3.875 $3.7 19 Consecutive Years $3.1 YoY Revenue Growth 2005 – 2023G $2.4 $2.2 $1.9 15% Total Revenue CAGR 2 2018 – 2023G midpoint 3 Neuroscience Oncology 4 Other Revenue $ in billions 2018 2019 2020 2021 2022 2023G 1 2023G = 2023 financial guidance as provided by Jazz Pharmaceuticals plc on and as of November 8, 2023; CAGR = compound annual growth rate; YoY = year-over-year. The company expects that, for the year ended December 31, 2023, reported total, 2 neuroscience and oncology revenues will meet the guidance range provided on November 8, 2023. Jazz Pharmaceuticals plc has not finalized its financial results for the year ended December 31, 2023, and actual results may differ; Based on mid-point of 3 4 7 January 2024 guidance provided by Jazz Pharmaceuticals plc on and as of November 8, 2023; Neuroscience revenues include high-sodium oxybate authorized generic royalties; Includes other revenues, other royalty and contract revenues, and revenues not associated with neuroscience or oncology.

GROWTH & EXECUTION PIPELINE COMMERCIAL Durable and Growing Commercial Portfolio 1 3 2018 Revenue 2023 Revenue Guidance Vision 2025 $1.9 billion $3.75 - $3.875 billion $5 billion + Xyrem & AG royalties + Xyrem & AG royalties Xyrem 60% 26% 26% 49% 2 of revenues driven Vision 2025: by oncology + Epidiolex 4 60% of revenues driven by oncology + Epidiolex + Other commercial growth, existing pipeline and future corporate development 5 Oncology + Epidiolex Revenue + Other 6 Sleep Revenue 1 2 3 AG royalties = high-sodium authorized generic royalty revenues. Guidance provided by Jazz Pharmaceuticals plc on and as of November 8, 2023; Chart based on YTD revenue reported in 3Q23; Vision 2025 represents Jazz 4 5 estimates of future performance in 2025; Includes contributions from other commercial growth, Jazz’s existing pipeline and future corporate development activities; Total revenues excluding revenues associated with Xywav, Xyrem, 8 January 2024 6 and high-sodium oxybate AG royalty revenues; Total sleep revenue includes Xywav, branded Xyrem and high-sodium oxybate AG royalty revenues.

会社

会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には

会社

会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開示情報をすべてご覧になるには株探プレミアムの登録が必要です。初めての方には「30日間の無料体験」実施中！会社開

会社