Jazz Pharmaceuticals plc Proxy Statement
2023 Annual Report
EMILY
RYLAZE® Patient
KASEN
EPIDIOLEX® Patient
[THIS PAGE INTENTIONALLY LEFT BLANK]
Our cover features Kasen and his mom, Brittany. Kasen experienced his first seizure at six months old while he and his mom were playing on the couch. Brittany noticed the left side of Kasen's body tense up and, at first, it wasn't clear what was happening to him. After a call to 911, he was swiftly taken to a hospital in an ambulance. Kasen's mom will never forget her fear associated with that first seizure and feeling helpless not knowing what caused it.
with prolonged and frequent seizures, movement and balance issues, delayed language, speech issues, sleeping difficulties and sensory integration disorders.1
Rare epilepsies can be medically complex, making diagnosis difficult. Physicians' understanding of epilepsy has evolved over the past several decades from a single disease to a multitude of epilepsy types and epilepsy
"You're so helpless during the seizures, you feel like you can't do anything to stop a seizure."
- Brittany, Kasen's mom
Kasen continued to have prolonged back-to- back seizures several times a month. His family needed to be vigilant to ensure he didn't hit his head and record how long the seizures were lasting. If the seizure was longer than five minutes, it required a trip to the hospital.
Finally, when he was two years old, Kasen was diagnosed with Dravet syndrome (DS), a rare and severe lifelong form of epilepsy that is associated
syndromes.2 Genetic testing can help with identifying the cause of epilepsy, especially in DS where over 80% of people diagnosed have changes in a specific gene, known as SCN1A.1
Once Kasen had a diagnosis, his journey to find an appropriate therapy began and he was prescribed several anti-seizure medicines while physicians and his family worked together to establish an effective treatment plan. Kasen
1. Dravet Syndrome Foundation. What is Dravet Syndrome? Available at https://www.dravetfoundation.org/what-is-dravet-syndrome/. Accessed March 2024. 2. Miller IP. Raring for change: Confluence of scientific discovery and advocate alignment warrants vital new investments in The Epilepsies. Epilepsy Behav. 2020 Oct;111:107276. doi: 10.1016/j.yebeh.2020.107276. Epub 2020 Aug 1.
was prescribed Epidiolex® (cannabidiol) upon approval in the U.S. in 2018, and he continues to take Epidiolex for the treatment of seizures associated with DS.
While Kasen still experiences seizures, the frequency and length of the seizures has been reduced. There was an 18-month span where Kasen was free of tonic-clonic seizures, which are characterized by convulsions that involve the entire body. Since he began treatment with Epidiolex, Kasen's mom and his family have noticed he can play for longer periods of time without having a seizure. Kasen especially enjoys ninja warrior obstacle courses in his backyard and at the gym.
Epidiolex®/Epidyolex® (cannabidiol) is the first prescription, plant-derivedcannabis-based medicine approved by the U.S. Food and Drug Administration (FDA), the European Commission and the Medicines and Healthcare products Regulatory Agency. Epidiolex/Epidyolex
is approved in nearly 40 countries outside of the U.S.
In the U.S., Epidiolex is approved 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.
Epidyolex is approved by the European Commission for use in addition to clobazam, to treat patients from two years of age and older with LGS or DS. It is also used to treat TSC with other epilepsy treatments in patients aged two and older.
A Phase 3 trial is ongoing in Japan evaluating Epidyolex in patients with LGS, DS and TSC.
The patient story shared in this communication depicts an individual patient's response to Epidiolex and is not representative of all patient responses.
"Epidiolex is a great intervention for Kasen. It's the small things that a lot of people take for granted."
- Brittany, Kasen's mom
2023 was a highly productive year for Jazz and I am pleased to report that we helped more patients, generated more than $3.8 billion in revenues and advanced multiple late-stage programs across our pipeline. Our performance in 2023 is reflective of the strong execution that has transformed our business over the last several years, including the diversification of our leading commercial medicines for sleep disorders, epilepsy and cancer.
Xywav®, Epidiolex® and Rylaze®, our key commercial growth drivers, delivered 27% year-over-year combined revenue growth. We remain confident
in the durability of our Sleep1 therapeutic area, which generated more than $1.9 billion in revenue in 2023, and our Oncology therapeutic area revenue surpassed $1 billion for the first time in 2023.
EMILY
RYLAZE® Patient
As a global biopharmaceutical company with in-house R&D capabilities, our innovative and passionate team members advanced differentiated assets in areas of significant unmet medical need. Our robust pipeline has multiple late-stage catalysts through 2025 in areas where we have proof-of-
concept data and we believe we have strong rationale for pursuing these indications. Importantly in 2023, we generated meaningful data on zanidatamab, a differentiated, bispecific antibody targeting HER2- expressing cancers. In the first quarter of 2024,
we completed the submission of our biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for zanidatamab in second-line (2L) biliary tract cancer (BTC). If approved, we expect zanidatamab would be the first HER2-targeted treatment specifically approved for BTC in the U.S. We remain focused on exploring science-driven approaches in areas where there are limited or no options for patients.
Our strong financial position and disciplined capital allocation underpin our progress towards Vision 2025. We ended 2023 with $1.6 billion in cash, cash equivalents and investments, which supports our ability to continue investing in key commercial growth drivers for near-term growth, pipeline for long-term growth and future corporate development. We believe these accomplishments in 2023 position us well for success in 2024 and to achieve Vision 2025 and beyond.
2023 ACCOMPLISHMENTS
COMMERCIAL
- Xywav: #1 treatment in narcolepsy and only low-sodium oxybate. Xywav net product sales grew 33% year-over-year in 2023. Xywav adoption in idiopathic hypersomnia (IH) continued as healthcare providers saw the profound impact oxybate therapy has on sleep inertia in IH patients.
- Epidiolex/Epidyolex®: #1 branded epilepsy treatment. Epidiolex net product sales grew
15% year-over-year in 2023, supported by global expansion through launches and reimbursement outside of the U.S. as well as meaningful data generation. Long-term studies demonstrated
1. Total Sleep revenue includes: Xywav, branded Xyrem and high-sodium oxybate authorized generic royalty revenues.
sustained reduction in treatment-resistant seizures, and caregiver reported outcomes of beyond-seizure benefits from the BECOME surveys differentiated Epidiolex from other anti- seizure medicines.
-
Rylaze: Sustained asparaginase activity over the course of therapy is essential to the treatment success of acute lymphoblastic leukemia or lymphoblastic lymphoma. Rylaze net product sales grew 40% year-over-year in 2023 and it remains the only therapy available to patients in the U.S. who have a hypersensitivity reaction to E. coli- derived asparaginase. Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase), marketed as Rylaze in the U.S. and Canada, received approval from the European Union, providing the opportunity to bring this important therapy to more patients
in need.
- Zepzelca®: #1 treatment in 2L small cell lung cancer (SCLC). We continue to hear positive feedback from healthcare providers on the clinical benefit of Zepzelca and ease of use and administration for patients. Enrollment was completed in the Phase 3 switch maintenance trial evaluating Zepzelca in combination with Tecentriq® (atezolizumab) in first-line (1L) SCLC.
PIPELINE
- Zanidatamab: Most de-riskednear-term opportunity. Zanidatamab is a differentiated, bispecific antibody that has the potential to be transformative to the current standard of care in multiple HER2-expressing cancers even in cases resistant to prior HER2-targeted agents. Impressive data were generated throughout 2023, including monotherapy
MULTIPLE PIPELINE CATALYSTS THROUGH 2025
KEY CLINICAL PROGRAMS
Zanidatamab
PHASE 1 | PHASE 2 | PHASE 3 | PHASE 4 / REGULATORY NEAR-TERM CATALYSTS | |
Phase 3 1L GEA (pivotal) | Phase 3 top-line PFS readout | |||
targeting late 2024 | ||||
Completed BLA submission | ||||
2L BTC (pivotal) | ||||
Phase 3 confirmatory trial in | ||||
Phase 3 1L BTC | ||||
1L BTC is ongoing | ||||
I-SPY2 Trial: | neoadjuvant treatment of locally advanced BC | |||
Phase 3 top-line PFS readout | ||||
ES 1L SCLC combo with Tecentriq | ||||
expected late 2024 / early 2025 | ||||
Zepzelca | Phase 4 2L SCLC observational trial | |||
Phase 3 2L SCLC confirmatory trial | ||||
Rylaze | EU: Initiated rolling ex-U.S. | |||
ALL/LBL | ||||
launch 4Q23 | ||||
JZP815 | RAF & RAS | mutant tumors | ||
JZP898
Epidyolex
Suvecaltamide (JZP385)
Solid tumors | Phase 1 trial initiated | |||||
Phase 3 top-line data readout | ||||||
Japan (LGS/DS/TSC) | ||||||
expected 2H24 | ||||||
Phase 2b top-line data readout | ||||||
Phase 2b essential tremor | ||||||
expected late 1H24 | ||||||
Parkinson's disease tremor | Oncolgy | Neuroscience | Near-term catalyst |
1L = first-line; 2L = second-line; ALL/LBL = acute lymphoblastic leukemia/lymphoblastic lymphoma; BC = breast cancer; BLA = biologics license application; BTC = biliary tract cancer; DS = Dravet syndrome; ES = extensive-stage; EU = European Union; GEA = gastroesophageal adenocarcinoma; LGS = Lennox- Gastaut syndrome; PFS = progression-free survival; SCLC = small cell lung cancer; TSC = Tuberous sclerosis complex.
DONNA
ZEPZELCA® Patient
activity in BTC, positive early overall survival and activity in combination with an anti-PD-1 in gastroesophageal adenocarcinoma (GEA).
- Completed the BLA submission to U.S. FDA for zanidatamab in 2L BTC. Plans are underway to submit zanidatamab in BTC to regulators outside the U.S.
- Ongoing Phase 3 trial in 1L GEA with top-lineprogression-free survival (PFS) data expected at the end of 2024.
- Plan to initiate Phase 3 EMPOWHER trial of zanidatamab and chemotherapy in post T-DXd patients with HER2+ advanced breast cancer in the second half of 2024.
- Additional ongoing clinical trials in HER2- expressing cancers such as breast, colorectal and ovarian cancers.
- Ongoing Zepzelca and Epidyolex Phase 3 trials for market/indication expansion.
- Phase 3 trial evaluating Zepzelca in combination with Tecentriq® (atezolizumab) in 1L SCLC with PFS top-line data expected in late 2024 or early 2025.
- A pivotal Phase 3 trial of Epidyolex for Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex in Japan with top-line data expected in the second half of 2024.
- Suvecaltamide: Highly selective and state- dependent modulator of T-type calcium channels, providing a differentiated mechanism of action.
- Ongoing Phase 2b trial in essential tremor (ET) with top-line data expected late in the first half of 2024. No new therapies have been approved to treat ET in over 50 years.
- Ongoing Phase 2 trial in Parkinson's disease tremor. Currently, there are no therapies approved for the treatmentoftremorinpatientswith Parkinson'sdisease.
-
Progressed JZP898, a promising candidate,
into the clinic. JZP898 is an engineered interferon alpha (IFNα) cytokine pro-drug that is activated
specifically within the tumor microenvironment where it can stimulate IFNα receptors on cancer- fighting immune effector cells. - Initiated a Phase 1 first-in-human clinical trial in solid tumors in 2023.
OPERATIONAL EXCELLENCE
- Delivering value through strategic capital allocation. Investing in organic growth from our diversified commercial portfolio and our promising R&D pipeline.
- Operating cash flow of $1.1 billion in 2023 and $1.6 billion in cash, cash equivalents and investments at year end.
- Successful corporate development has been key to our growth and diversification. We have an experienced and active corporate development team and will continue to consider multiple options from in-licensing to acquisitions.
In 2024, we anticipate continued top-line growth, including double-digit growth from our Oncology therapeutic area and across our combined key growth drivers: Xywav, Epidiolex and Rylaze.
An important part of successfully executing our long-term strategy anchors on strong corporate
governance, social responsibility and environmental stewardship. In 2023, we published our 2022 Corporate Sustainability and Social Impact (CSSI) report, which references the GRI and Sustainability Accounting Standards Board (SASB) frameworks, and can be found on our website at https://www. jazzpharma.com/wp-content/uploads/2023/09/Jazz_2022_CSSI-Report.pdf.
Thank you for your continued support as we focus on identifying and developing durable, differentiated medicines with the potential to transform the lives of patients and their families.
Bruce C. Cozadd
Chairperson and Chief Executive Officer
STRONG FINANCIAL EXECUTION
TOTAL REVENUES
- in millions (audited)
$3,659 | $3,834 | |||
$3,094 | ||||
$2,162 | $2,364 | |||
2019 | 2020 | 2021 | 2022 | 2023 |
15% 4-YEAR CAGR |
NON-GAAP ADJUSTED NET INCOME PER DILUTED SHARE1
(unaudited) | ||||
$18.29 | ||||
$15.382 | $16.23 | |||
$12.46 | $13.203 | |||
2019 | 2020 | 2021 | 2022 | 2023 |
NET CASH PROVIDED BY
OPERATING ACTIVITIES
- in millions (audited)
$1,272 | ||||
$1,092 | ||||
$900 | ||||
$776 | $779 | |||
2019 | 2020 | 2021 | 2022 | 2023 |
- Non-GAAPadjusted net income per diluted share is a non-GAAP financial measure, for further information, see "Non-GAAP Financial Measures". Reconciliations of GAAP net income (loss) per diluted share to non-GAAP adjusted net income per diluted share can be found under the section Executive Compensation-Compensation Discussion and Analysis-Additional Compensation Information-Reconciliations of Non-GAAP Adjusted Net Income.
- Commencing in 2020, following consultation with the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission, the Company no longer excludes upfront and milestone payments from the Company's non-GAAP adjusted net income. For the purposes of comparability, non-GAAP adjusted financial measures for the year ended December 31, 2019 have been updated to reflect this change. 3. Non-GAAP adjusted net income per diluted share for the year ended December 31, 2022, was impacted by $1.48 per share following the adoption of ASU 2020-06, and by acquired IPR&D expense which had the effect of reducing adjusted net income per diluted share by $5.35 per share, compared to the year ended December 31, 2021. CAGR = Compound Annual Growth Rate; IPR&D = In-process research and development
NOTICE OF 2024 ANNUAL GENERAL MEETING
OF SHAREHOLDERS
TO BE HELD ON JULY 25, 2024
Dear Shareholder:
The 2024 annual general meeting of shareholders (the "annual meeting") of Jazz Pharmaceuticals plc, a public limited company formed under the laws of Ireland (the "company"), will be held on Thursday, July 25, 2024, at 9:45 a.m. local time at our corporate headquarters located at Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland, for the following purposes:
- To elect by separate resolutions each of the four nominees for director named in the accompanying proxy statement (the "proxy statement") to hold office until the 2027 annual meeting of shareholders (Proposal 1).
- To ratify, on a non-binding advisory basis, the appointment of KPMG as our independent auditors for the fiscal year ending December 31, 2024 and to authorize, in a binding vote, our board of directors, acting through our audit committee, to determine the independent auditors' remuneration (Proposal 2).
- To approve, on a non-binding advisory basis, the compensation of our named executive officers, or NEOs, as disclosed in the accompanying proxy statement (Proposal 3).
- To indicate, on a non-binding advisory basis, the preferred frequency of the advisory vote on the compensation of our named executive officers (Proposal 4).
- To grant our board of directors authority under Irish law to allot and issue ordinary shares for cash without first offering those ordinary shares to existing shareholders pursuant to the statutory pre- emption right that would otherwise apply (Proposal 5).
- To approve any motion to adjourn the annual meeting, or any adjournments thereof, to another time and place to solicit additional proxies if there are insufficient votes at the time of the annual meeting to approve Proposal 5 (Proposal 6).
To conduct any other business properly brought before the annual meeting.
Proposals 1, 2, 3, 4 and 6 are ordinary resolutions, requiring the affirmative vote of a majority of the votes cast (in person or by proxy) at the annual meeting. Proposal 5 is a special resolution, requiring the approval of not less than 75% of the votes cast (in person or by proxy) at the annual meeting.
In addition to the above proposals, the annual meeting will also receive and consider our Irish statutory financial statements for the fiscal year ended December 31, 2023 and the reports of the directors and auditors thereon. There is no requirement under Irish law that the Irish statutory financial statements be approved by the shareholders, and no such approval will be sought at the annual meeting. Under our Constitution (our "constitution"), and the Irish Companies Act 2014 (the "2014 Act"), Proposals 1 and 2 are deemed to be ordinary business, and Proposals 3, 4, 5 and 6 are deemed to be special business.
The record date for the annual meeting is May 29, 2024. Only shareholders of record at the close of business on that date may vote at the annual meeting or any adjournment or postponement thereof. The Notice of Internet Availability of Proxy Materials and our proxy materials, which include this proxy statement, our annual letter to shareholders and our 2023 Annual Report on Form 10-K, are first being mailed to shareholders on or about June 14, 2024.
A shareholder entitled to attend and vote at the annual meeting is entitled to appoint one or more proxies to attend, speak and vote instead of him or her at the annual meeting, using the proxy card provided (or the form of proxy contained in section 184 of the 2014 Act) or using an electronic proxy card by telephone or via the internet in the manner described in this proxy statement. A proxy need not be a shareholder of record.
Whether or not you expect to attend the meeting, please vote as soon as possible. You may vote your shares:
Over the Telephone 1-800-690-6903
Via the Internet
www.proxyvote.com
By Mail
Complete, sign and return proxy card
In Person
Attend Annual Meeting
If you received a proxy card or voting instruction card by mail, you may submit your proxy card or voting instruction card by mailing your proxy card or voting instruction card in the envelope provided. Proxy cards must be received by July 24, 2024. Electronic proxy cards submitted via the internet or by telephone must be received by 11:59 p.m., U.S. Eastern Time, on July 24, 2024. It may not be possible to count proxy cards received after the relevant time towards voting. Proxy cards received will be forwarded to our registered office electronically before commencement of the annual meeting to comply with Irish law. Even if you have voted by proxy, you may still vote in person if you attend the meeting. Please note, however, that if the record holder of your ordinary shares is a broker, bank or other agent, and you wish to vote at the meeting, you must obtain a proxy issued in your name from that record holder.
Proxy
Important Notice Regarding the Availability of Proxy Materials for the annual meeting of shareholders to be held on July 25, 2024, at 9:45 a.m. local time at our corporate headquarters located at Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland.
The proxy statement, our letter to shareholders, our Irish statutory financial statements and our 2023 Annual Report on Form 10-K
are available at https://materials.proxyvote.com/G50871.
By order of our board of directors,
/s/ Aislinn Doody
Aislinn Doody, Company Secretary
Dublin, Ireland
June 14, 2024
TABLE OF CONTENTS
PROXY OVERVIEW | 1 |
Business Overview | 1 |
Information About our Board of Directors | 2 |
Shareholder and Other Stakeholder Engagement | 4 |
Corporate Sustainability and Social Impact | 6 |
Summary of Shareholder Voting Matters and Board | |
Recommendations | 9 |
GENERAL | 13 |
PROPOSAL 1 ELECTION OF DIRECTORS | 14 |
CORPORATE GOVERNANCE AND BOARD MATTERS | 22 |
Overview | 22 |
Board Leadership Structure | 22 |
Lead Independent Director | 23 |
Classified Board Structure | 23 |
Independence of our Board | 23 |
Director Commitments | 24 |
Board Evaluation | 24 |
Board Refreshment | 24 |
Committees of our Board | 25 |
Board and Committee Information | 25 |
Audit Committee | 25 |
Compensation and Management Development Committee | 26 |
Compensation Committee Processes and Procedures | 27 |
Nominating and Corporate Governance Committee | 28 |
Science and Medicine Committee | 29 |
Risk Oversight | 30 |
Ethical Business Practices | 31 |
Other Corporate Governance Matters | 32 |
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL | |
OWNERS AND MANAGEMENT | 34 |
EXECUTIVE OFFICERS | 36 |
EXECUTIVE COMPENSATION | 38 |
Compensation Discussion and Analysis | 38 |
Summary of Compensation | 67 |
Grants of Plan-BasedAwards | 69 |
Description of Compensation Arrangements | 70 |
Outstanding Equity Awards at Fiscal Year-End | 73 |
Option Exercises and Stock Vested | 75 |
Potential Payments upon Termination or Change in Control | 76 |
Pay Ratio Disclosure | 81 |
Item 402(v) Pay versus Performance | 81 |
Compensation Consultant Fees | 84 |
Compensation Committee Report | 85 |
DIRECTOR COMPENSATION | 86 |
CERTAIN RELATIONSHIPS AND RELATED PARTY | |
TRANSACTIONS | 90 |
PROPOSAL 2 RATIFY, ON A NON-BINDING ADVISORY | |
BASIS, THE APPOINTMENT OF KPMG AS THE | |
INDEPENDENT AUDITORS FOR THE FINANCIAL YEAR | |
ENDING DECEMBER 31, 2024 AND AUTHORIZE, IN A | |
BINDING VOTE, OUR BOARD OF DIRECTORS, ACTING | |
THROUGH OUR AUDIT COMMITTEE, TO DETERMINE | |
KPMG'S REMUNERATION | 92 |
Independent Registered Public Accounting Firm Fees and | |
Services | 92 |
Pre-ApprovalPolicies and Procedures | 93 |
Independence | 93 |
Report of Audit Committee of our Board | 94 |
PROPOSAL 3 NON-BINDING ADVISORY VOTE ON | |
EXECUTIVE COMPENSATION | 95 |
PROPOSAL 4 NON-BINDING ADVISORY VOTE ON THE | |
PREFERRED FREQUENCY OF THE ADVISORY VOTE ON | |
EXECUTIVE COMPENSATION | 97 |
PROPOSAL 5 BOARD AUTHORITY TO ALLOT AND ISSUE | |
ORDINARY SHARES FOR CASH WITHOUT FIRST | |
OFFERING SHARES TO EXISTING SHAREHOLDERS | 98 |
PROPOSAL 6 ADJOURNMENT PROPOSAL | 100 |
QUESTIONS AND ANSWERS ABOUT THESE PROXY | |
MATERIALS AND VOTING | 101 |
OTHER MATTERS | 107 |
Presentation of Irish Statutory Financial Statements | 107 |
Delinquent Section 16(a) Reports | 107 |
Registered and Principal Executive Offices | 107 |
Shareholder Proposals and Director Nominations for the 2025 | |
Annual Meeting | 107 |
Householding of Proxy Materials | 108 |
Annual Report on Form 10-K | 108 |
Special Note Regarding Forward-Looking Statements | 108 |
General | 109 |
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Jazz Pharmaceuticals plc published this content on 14 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 June 2024 23:33:06 UTC.