Full Press Release Details
41st Annual J.P. Morgan Healthcare
Conference Innovating to Transform the Lives of Patients and Their Families January 9, 2023 Grace Epidiolex patient Exhibit 99.1
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; 2022 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 and its growth opportunities and the ability of Zepzelca to gain market share and its 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 and net leverage ratio target; 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, including completion of enrollment in the Zepzelca first line SCLC study and availability of zanidatamab's Phase III
top-line GEA data; planned or anticipated regulatory submissions and filings; 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 the Company's oxybate products, Zepzelca and other key marketed products; effectively launching and commercializing the
Company's other products and 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 the Company's sBLA seeking approval for a
revised dosing label for Rylaze may not be approved by FDA 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 being experienced, and expected to continue to be experienced, by the Company; the Company's failure to realize the expected benefits of its acquisition
of GW Pharmaceuticals, including the blockbuster potential of Epidiolex; 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 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 2022 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, 2022; 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, 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.
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 net income which excludes from GAAP reported net income (loss) certain items, as detailed in the reconciliation tables that follow
in the Appendix hereto, and adjusts for the income tax effect of the non-GAAP adjustments and the impact of the change in the statutory tax rate in the U.K. The Company also 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. The Company also uses a pro forma non-GAAP net leverage ratio calculated as net adjusted debt (defined as total GAAP debt, after giving effect to the Company's hedging arrangements for its Euro Term Loan B, net of cash,
cash equivalents and investments) divided by Adjusted EBITDA for the most recent period of four consecutive completed fiscal quarters. EBITDA is defined as net income before income taxes, interest expense, depreciation and amortization. Adjusted
EBITDA is defined as EBITDA further adjusted to exclude certain other charges and adjustments as detailed in the pro forma non-GAAP net leverage ratio reconciliation table that follows in the Appendix hereto and is calculated in accordance with the
definition of Adjusted Consolidated EBITDA as set out in the Company's credit agreement entered into in May 2021 (the Credit Agreement). 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, to identify
operating trends in the Company's business and to understand the Company's ability to delever. 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.
Our Purpose Who We Are is to innovate
to transform the lives of patients and their families. 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. By transforming
biopharmaceutical discoveries into novel medicines, we are working to give people around the world the opportunity to redefine what's possible, to make the "small wins" big again. Casey Xywav IH Patient Leighton Rylaze ALL Trial
Participant IH = idiopathic hypersomnia; ALL = acute lymphoblastic leukemia
Expect to meet 2022 total, neuroscience
and oncology revenue guidance1 18% Revenue CAGR2 2017 - 2022 18 Consecutive Years YoY revenue growth 2005 - 2022 $3,094 Revenue $ in millions $3,600 - $3,7001 CAGR - compound annual growth rate, YoY = year-over- year. 1Guidance
provided by Jazz Pharmaceuticals plc on and as of November 9, 2022. The company expects that, for the year ended December 31, 2022, reported total, neuroscience and oncology revenues will meet the guidance range provided on November 9, 2022. Jazz
Pharmaceuticals plc has not finalized its financial results for the year ended December 31, 2022, and actual results may differ. 2Based on mid-point of guidance provided by Jazz Pharmaceuticals plc on and as of November 9, 2022. Jazz Has A Track
Record of Strong Execution
Vision 2025 to Deliver Sustainable
Growth and Enhanced Value PIPELINE Delivering 5 novel product approvals by end of the decade Generating $5 billion in revenue in 2025 COMMERCIAL Driving 5%1 adjusted operating margin2 improvement from 20213 to 2025 OPERATIONAL EXCELLENCE
Vision 2025 represents Jazz estimates of future performance. 1Five percentage points; 2Adjusted operating margin is a non-GAAP financial measure. For further information, see "Non-GAAP Financial Measures"; 32021 adjusted operating margin
calculation is included in the appendix for reference.
Vision 2025 is Built on Our Core
Strengths Vision 2025 represents Jazz estimates of future performance. 1Five percentage points; 2Adjusted operating margin is a non-GAAP financial measure. For further information, see "Non-GAAP Financial Measures"; 32021 adjusted
operating margin calculation is included in the appendix for reference. Executing successful launches #1 treatment in narcolepsy & Epidiolex blockbuster potential Rapidly growing oncology business Ability to invest meaningfully in R&D
Expanded R&D capabilities Breadth and depth of pipeline Strategic R&D collaborations Disciplined capital allocation Already achieved operating margin improvement - providing additional flexibility to invest in growth drivers PIPELINE
Delivering 5 novel product approvals by end of the decade Generating $5 billion in revenue in 2025 COMMERCIAL Driving 5%1 adjusted operating margin2 improvement from 20213 to 2025 OPERATIONAL EXCELLENCE
Strong 2022 Execution Positions Jazz
Well to Achieve Vision 2025 2L = second line, BTC = Biliary tract cancer; CAGR = compound annual growth rate; IH = idiopathic hypersomnia, IM = intramuscular; IND = Investigational New Drug Application, M/W/F = Monday, Wednesday, Friday, PDT =
Parkinson's disease tremor; SCLC = small cell lung cancer, YOY = Year-over-year. 1Based on 2022 guidance midpoint; 2United Kingdom, Germany, Italy, Spain and France ; 3YTD = Year-to-date September 30, 2022. Cash, cash equivalents and
investments were $899.4 million as of September 30, 2022; 4Net leverage ratio (on a pro forma non-GAAP adjusted basis), adjusted EBITDA and adjusted operating margin are non-GAAP financial measures; FY 2022 G adjusted operating margin
reconciliation is included in the Appendix; For further information, see "Non-GAAP Financial Measures". Xywav : Compelling adoption across narcolepsy & IH drives oxybate durability Zepzelca : Established as treatment of
choice in 2L SCLC Rylaze : Strong demand Significant YOY growth Now launched in all 5 key European markets2 Significant revenue growth 2017 to 2022 5-year CAGR of 18%1 Demonstrated launch excellence Epidiolex blockbuster potential
COMMERCIAL Added 3 exciting new molecules to pipeline in 2022 Zanidatamab: HER2-targeted bispecific antibody JZP441: Orexin-2 receptor agonist JZP898: IFN INDUKINE molecule Significant 2022 R&D execution 4 INDs in 2022 &
multiple additional INDs expected in 2023 7 clinical trials initiated Expanded suvecaltamide program into PDT Positive zanidatamab BTC top-line data Approval of Rylaze M/W/F IM PIPELINE Strong operational and financial foundation to deliver Vision
2025 is underpinned by: Strong operating cash flow of $930M YTD3 , ~$900M3 cash and $500M undrawn revolver 2022 projected adjusted operating margin4 of 49%1 provides additional flexibility to invest in growth drivers Delevered4 two full turns since
close of GW transaction: Provides continued strategic flexibility Reduced total debt Increased adjusted EBITDA4 OPERATIONAL EXCELLENCE
Strategic Transactions Drive Growth and
Shareholder Value OPERATIONAL EXCELLENCE Corporate Development Progress Contributes to Vision 2025 Transformational Transaction GW ACQUISITION Epidiolex blockbuster potential Combined company - leader in neuroscience Global commercial and
operational footprint well positioned to maximize the value of diversified portfolio Leadership Enhancing Transaction OREXIN-2 AGONIST Strengthens leadership in sleep Expands neuroscience pipeline Potential to be complementary to oxybate therapy
Novel Late-Stage Asset Transaction ZANIDATAMAB Novel late-stage asset with compelling anti-tumor activity Positive top-line clinical data in BTC Phase 3 GEA top-line data expected in 2024 Rapidly Accretive Transaction ZEPZELCA Rapidly established as
treatment of choice in 2L SCLC $535 million1 in revenue since launch in mid-2020 Robust development program underpins long-term commercial growth strategy Partner of Choice CORPORATE DEVELOPMENT Demonstrated commercial excellence Leader in
neuroscience Rapidly growing oncology business Expanded R&D capabilities In-house development expertise 2L = second-line, BTC = biliary tract cancer, GEA = gastroesophageal adenocarcinoma, SCLC = small cell lung cancer. 1Net product sales from
launch in July 2020 to September 30, 2022.
Continuing to Rapidly Transform
Revenue Base 1Guidance provided by Jazz Pharmaceuticals plc on and as of November 9, 2022. The company expects that, for the year ended December 31, 2022, reported total revenues will meet the guidance range provided on November 9, 2022. Jazz
Pharmaceuticals plc has not finalized its financial results for the year ended December 31, 2022, and actual results may differ 2Chart based on YTD revenue reported in 3Q22. 3Vision 2025 represents Jazz estimates of future performance in 2025;
4Products launched or acquired since 2019. Vision 20253 $5 billion 2022 Revenue Guidance $3.6-$3.7 billion1 2019 Revenue $2.2 billion 46%2 24% Vision 2025: 60% of revenues driven by products other than oxybate Expect to Meet 2022 Target of 60-65% of
Net Product Sales From Newer Products4 60% + Other commercial growth, existing pipeline and future corporate development + AG royalties of revenues driven by products other than oxybate
Vision 2025 Execution: Commercial
Generating $5 Billion in Revenue in 2025 January 2023
Commercial Excellence Drives Growth
POSITIONS JAZZ WELL TO DELIVER ON VISION 2025 TRACK RECORD OF SUCCESSFUL COMMERCIAL EXECUTION Leading neuroscience franchises #1 treatment in narcolepsy & global cannabinoid franchises Blockbuster potential Durable oxybate
franchise Executing successful Xywav Launches ~$2 billion oxybate franchise ~$2.5 billion Epidiolex + oncology franchises ~$0.5 billion in other commercial growth, existing pipeline and future corporate development COMMERCIAL PIPELINE OPERATIONAL