CORPORATE OVERVIEW
INNOVATING TO TRANSFORM THE LIVES OF PATIENTS
AUGUST 2021
Sara
© 2021 Jazz Pharmaceuticals. All rights reserved. | JZP258 Trial Participant |
Life-Changing Medicines. Redefining Possibilities.
Caution Concerning Forward-Looking Statements
This presentation contains forward-looking statements, including, but not limited to, statements related to: expected upcoming value drivers for and 2021 goals of Jazz Pharmaceuticals (the Company), including with respect to revenue diversification; the near-term blockbuster potential of Epidiolex®; the Company's pipeline and targeted investments providing for sustainable growth; the commercial and growth potential of the Company's products and product candidates; the launch of Xywav™ in idiopathic hypersomnia (IH) and the timing thereof; the Company's plans to submit additional data for Rylaze™; expected initiations of Epidiolex, nabiximols, JZP385, JZP150 and Zepzelca™ clinical trials and the timing thereof; the anticipated development of Vyxeos® in additional populations and indications; 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 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 risks of integrating Xywav in IH in our REMS; 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 as a result of the effects of the COVID-19 pandemic; the Company's failure to realize the expected benefits of its acquisition of GW Pharmaceuticals plc, including the risk that the legacy GW Pharmaceuticals business will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; the ultimate duration and severity of the COVID-19 pandemic and resulting global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; regulatory initiatives and changes in tax laws; market volatility; protecting and enhancing the Company's intellectual property rights; 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; government investigations, legal proceedings and other actions; identifying and acquiring, in-licensing or developing additional products or product candidates, 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 to fund its debt service obligations; the Company's ability to achieve expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the possibility that, if the Company does not achieve the perceived benefits of the acquisition of GW Pharmaceuticals as rapidly or to the extent anticipated by financial analysts or investors, the market price of the Company's ordinary shares could decline; and other risks and uncertainties affecting the Company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' and GW Pharmaceuticals' Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2020, GW Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2020, and future filings and reports by the Company, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. 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. The forward-looking statements made in this communication 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 August 2021
Life-Changing Medicines. 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. In particular, the Company presents non-GAAP adjusted net income (and the related per share measure). Non-GAAP adjusted net income (and the related per share measure) exclude from GAAP reported net income (loss) (and the related per share measure) certain items, as detailed in the reconciliation table included in the Appendix to this presentation, and adjust for the income tax effect of non-GAAP adjustments and impact of the change in the statutory tax rate in the U.K.
The Company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts. In particular, the Company believes that each of these non-GAAP financial measures, when considered together with the Company's financial information and impact of the change in the statutory tax rate in the UK 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. 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 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. For example, commencing in 2020, the Company no longer excludes upfront and milestone payments from the Company's non-GAAP adjusted net income, its line item components and non-GAAP adjusted EPS. 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 presentation 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.
Additional Cautionary Language
Certain information in this presentation is based upon management forecasts and reflects prevailing conditions and management's views as of this date, all of which are subject to change. In preparing this presentation, we have relied upon and assumed, without independent verification, the accuracy and completeness of all information available from public sources or which was provided to us by third parties or which was otherwise reviewed by us. The information contained herein is subject to change, completion or amendment and we are not under any obligation to keep you advised of such changes.
3 August 2021
Patient-Centric Innovation Drives our Strategy
Targeting Two Therapeutic Areas With Significant Market Opportunities
Focus on patient populations with high unmet needs
Target addressable physician audiences for efficient commercialization
Identify and develop durable, differentiated assets
Leverage our integrated capabilities and global infrastructure
NEUROSCIENCE
&
ONCOLOGY
4 August 2021
Focused Execution Drives Long-Term Value
Significant Execution | Upcoming Value Drivers | ||
• Affirmed 2021 revenue guidance of $3.02 - $3.18 billion1 | • Revenue diversification target of >65% of 2022 net sales from | ||
• 41% of net sales in 2Q21 from new products | new products | ||
• Executed 4 of 5 key product launches in 2020-2021 | • Additional corporate development initiatives | ||
• Closed GW transaction on May 5, 2021; accelerates | • Planned Phase 3 pivotal trial for Epidiolex in Epilepsy with | ||
+ | revenue growth and diversification | Myoclonic-Atonic Seizures (EMAS) in 1H22 | |
• | Integration progressing well | • Expect to initiate third Phase 3 nabiximols trial in MS spasticity | |
• | Positive performance of Epidiolex®, near-term blockbuster | in 2021 | |
potential | • GW cannabinoid platform expands Jazz R&D portfolio and | ||
capabilities | |||
EDS and Cataplexy in Narcolepsy2 | Idiopathic Hypersomnia | ||
• ~5,100 active patients on XywavTM exiting 2Q21 | • FDA approved on August 12, 20213 | ||
• Lower sodium resonating with HCPs and patients; | • Preparing for 4Q21 commercial launch | ||
reinforced by FDA summary of clinical superiority to Xyrem® | • Ongoing unbranded disease education initiatives | ||
• | FDA granted ODE | ||
• Establishing ZepzelcaTM as standard of care in 2L SCLC | • Driving continued share growth in 2L setting | ||
• Continued demand and market share growth in 2L SCLC | • Robust development program | ||
• FDA approval under RTOR on June 30, 20214 | • Addressing significant need for high quality therapeutic option with | ||
• Commercial launch on July 15, 2021 | reliable supply for ALL/LBL patients | ||
• Evaluating additional dosing options and IV route of administration | |||
1. Guidance provided by Jazz Pharmaceuticals plc on and as of August 3, 2021. 2. Full prescribing information at www.xywav.com, including BOXED Warning and Medication | 5 | August 2021 | |
Guide; 3. Full prescribing information at https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf4. Full prescribing information at www.rylaze.com | |||
This is an excerpt of the original content. To continue reading it, access the original document here.
Attachments
- Original document
- Permalink
Disclaimer
Jazz Pharmaceuticals plc published this content on 18 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 August 2021 23:43:01 UTC.