0001232524falseJazz Pharmaceuticals plc00012325242024-07-312024-07-31

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
 
FORM 8-K
 
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
July 31, 2024
Date of Report (Date of earliest event reported)
 
 
JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
 
     
Ireland 001-33500 98-1032470
(State or Other Jurisdiction
of Incorporation)		(Commission
File No.)		(IRS Employer
Identification No.)
Fifth Floor, Waterloo Exchange,
Waterloo Road, Dublin 4, Ireland D04 E5W7
(Address of principal executive offices, including zip code)

011-353-1-634-7800
(Registrant's telephone number, including area code)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Ordinary shares, nominal value $0.0001 per share
JAZZ
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐



Item 2.02. Results of Operations and Financial Condition.
On July 31, 2024, Jazz Pharmaceuticals plc (the “Company”) issued a press release (the “Press Release”) announcing financial results for the Company for the quarter ended June 30, 2024. A copy of the Press Release is furnished as Exhibit 99.1 to this current report.
The information in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company whether made before or after the date hereof, regardless of any general incorporation language in such filing.


Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
Exhibit
Number		Description
99.1
104104 Cover Page Interactive Data File (embedded within the Inline XBRL document)




SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
  
JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY
 
By:/s/ Philip L. Johnson
Name:Philip L. Johnson
Title:Executive Vice President and Chief Financial Officer
Date: July 31, 2024






Exhibit 99.1
jazzpharma_logoxfullcolora.jpg

Jazz Pharmaceuticals Announces Second Quarter 2024 Financial Results
and Updates 2024 Financial Guidance

– 15% year-over-year revenue increase from combined key growth drivers:
Xywav®, Epidiolex® and Rylaze® –
– Oncology revenues grew 10% year-over-year –
– Zanidatamab granted Priority Review by U.S. FDA for 2L BTC; PDUFA date of November 29, 2024 –
– Near-term, late-stage pipeline catalysts anticipated through 2025 –
– Narrowing 2024 total revenue guidance to $4.0 to $4.1 billion –
– Affirming GAAP and non-GAAP adjusted net income guidance –

DUBLIN, July 31, 2024 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the second quarter of 2024 and updated guidance for 2024.

“Jazz’s record revenues of over $1 billion in the second quarter were driven by strong execution and increased demand for our key growth drivers, Xywav, Epidiolex and Rylaze. Our launch preparations are well underway for zanidatamab, which was recently granted Priority Review in BTC, and we are pleased to have initiated the Phase 3 EmpowHER trial in HER2-positive breast cancer in patients whose disease has progressed after T-DXd treatment,” said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. “Based on projections for the remainder of the year, we are narrowing and maintaining the mid-point of our Neuroscience guidance and lowering our Oncology guidance. Importantly, our Oncology guidance still includes double-digit growth at the mid-point and we continue to expect double-digit growth from our combined key growth drivers in 2024.”

Key Highlights

•Key growth drivers:
◦Xywav net product sales grew 13% year-over-year.
◦Epidiolex/Epidyolex® net product sales grew 22% year-over-year.
◦Rylaze/Enrylaze® net product sales grew 6% year-over-year.
•Zanidatamab:
◦Granted Priority Review by U.S. FDA for 2L BTC; MAA validated by EMA.
◦Initiated Phase 3 EmpowHER trial in late-line HER2+ breast cancer.
•Near-term, late-stage pipeline catalysts anticipated:
◦Top-line data from Epidyolex Phase 3 trial in Japan in 2H24.
◦Top-line data from Zepzelca® 1L SCLC Phase 3 trial by the end of 2024.
◦Top-line PFS data from zanidatamab in Phase 3 1L GEA estimated to be 2Q25.
•2024 Financial Guidance:
◦Narrowing 2024 total revenue guidance range to $4.0 to $4.1 billion.
◦Narrowing Neuroscience guidance to $2.825 to $2.925 billion.
◦Lowering Oncology guidance to $1.10 to $1.15 billion.
◦Affirming GAAP net income guidance of $385 to $530 million and non-GAAP adjusted net income guidance of $1.275 to $1.350 billion.1
◦Raising GAAP EPS guidance range by approximately $1.00 to $6.00 to $8.00 and non-GAAP EPS guidance to $19.20 to $20.30.1
1 See "Non-GAAP Financial Measures."
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•Vision 2025: The Company is no longer providing the Vision 2025 metrics; however, the priorities highlighted in Vision 2025 remain the same:
◦Achieving commercial excellence to drive a growing and diversified revenue base;
◦Reaching more patients and creating value for shareholders by investing in our business and pipeline, including through corporate development; and
◦Maintaining disciplined capital allocation to generate long-term sustainable growth and value.

Business Updates

Key Commercial Products
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales were $368.5 million in 2Q24, an increase of 13% compared to the same period in 2023.
•There were approximately 13,225 active Xywav patients exiting 2Q24 comprised of:
◦Approximately 9,925 narcolepsy patients.
◦Approximately 3,300 idiopathic hypersomnia (IH) patients, with 250 net patient adds.
•As the only low-sodium oxybate and the only therapy approved to treat IH, expect Xywav to remain the oxybate of choice.
•Expert recommendations for optimizing flexible and individualized dosing regimens of low-sodium Xywav in narcolepsy and IH were published in Neurology and Therapy. Nearly 90% of HCPs surveyed felt the ability to adjust Xywav dosing to accommodate routine changes was important or very important and had a positive impact on their ability to provide care.
•Data presented at SLEEP 2024 included two late-breaking posters assessing the burden experienced by patients with IH. One poster demonstrated substantial comorbidity and health-related quality-of-life burdens for IH patients. Another poster reported greater economic burden, including work productivity impairment, compared to people living without IH.

Xyrem® (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
•Xyrem net product sales were $62.2 million in 2Q24, a decrease of 61% compared to the same period in 2023.
•Royalties from high-sodium oxybate AGs were $54.2 million in 2Q24, an increase of $48.7 million compared to the same period in 2023.
•The Company expects high-sodium oxybate AG royalty revenue to exceed $200 million in 2024.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales were $247.1 million in 2Q24, an increase of 22% compared to the same period in 2023.
•Outside of the U.S., Epidyolex is approved in more than 35 countries with additional launches and reimbursements anticipated through the end of 2024.
•A plain language summary of the BECOME survey results was published in Future Neurology. In addition to reporting an 85% reduction in the frequency of seizures, caregivers also reported improvements in non-seizure benefits such as cognitive, emotional and social functioning.
•Retrospective review of the validated REST-LGS questionnaire was evaluated in a real-world setting and the majority of patients who had not been previously diagnosed with Lennox-Gastaut syndrome (LGS) were identified, highlighting the potential of the screening tool to identify patients with LGS who may benefit from further diagnostic evaluation.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Rylaze/Enrylaze net product sales were $107.8 million in 2Q24, an increase of 6% compared to the same period in 2023.

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Zepzelca (lurbinectedin):
•Zepzelca net product sales were $81.0 million in 2Q24, an increase of 15% compared to the same period in 2023.
•Enrollment in the Phase 3 trial evaluating first-line (1L) use of Zepzelca in combination with Tecentriq® (atezolizumab) in small cell lung cancer (SCLC), in partnership with Roche, was completed in 1Q24.
•The Company expects top-line progression-free survival (PFS) data readout by the end of 2024.

Key Pipeline Highlights
Zanidatamab:
•In 2Q24, the U.S. FDA accepted and granted Priority Review of the Biologics License Application for zanidatamab with a target action date of November 29, 2024. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for biliary tract cancer (BTC) in the U.S. A confirmatory trial in 1L metastatic BTC is ongoing.
•The European Medicines Agency (EMA) validated the marketing authorization application (MAA) for zanidatamab in second-line (2L) BTC.
•Updated zanidatamab data from the HERIZON-BTC-01 trial were presented at the ASCO Annual Meeting 2024, demonstrating a confirmed objective response rate was maintained at 41.3%, median duration of response increased by approximately two months to 14.9 months compared to findings reported in 2023, and a median overall survival of 15.5 months in all patients with HER2+ BTC and 18.1 months in patients with immunohistochemistry (IHC) 3+ tumors.
•The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is ongoing and enrollment remains on track. Based on an updated blinded assessment of progression events, the Company estimates top-line PFS data will be available in 2Q25. The Company continues to track events in the trial relative to the initial protocol assumptions.
•The Company initiated the Phase 3 EmpowHER-BC-303 trial to evaluate zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous trastuzumab deruxtecan (T-DXd) treatment.

Suvecaltamide (JZP385):
•Announced top-line results from the Phase 2b trial of suvecaltamide in essential tremor did not achieve statistical significance. The improvement in placebo from baseline to week 12 exceeded the Company’s expectations and was higher than what was observed for placebo in the prior T-CALM trial of suvecaltamide.
•A Phase 2 trial in patients with Parkinson's disease tremor (PDT) is ongoing, with results expected 1Q25. The Company awaits results from the PDT trial to determine next steps, if any, for the program.

JZP441:
•Pending input from FDA, the Company is planning to initiate a Phase 1b trial of JZP441 in type 1 narcolepsy patients in 2H24.
•Expect this trial will further the Company's understanding of JZP441 and more broadly orexin agonism, providing key learnings that could inform future development efforts.

Share Repurchases of Approximately $161 Million and New $500 Million Authorization
The Company resumed repurchases of its ordinary shares on the open market in the second quarter of 2024 as part of the Company's previously authorized and announced share repurchase program. Under this share repurchase program, the Company was authorized to repurchase its ordinary shares for up to an aggregate purchase price of $1.5 billion, exclusive of any brokerage commissions. As of June 30, 2024, a nominal amount remained outstanding under this authorization, reflecting the purchase of shares worth approximately $161 million during the second quarter of 2024. The remaining amount will be utilized under the newly authorized repurchase program described below.
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On July 25, 2024, the Board of Directors authorized a new share repurchase program with no expiration date pursuant to which the Company may repurchase its ordinary shares for up to an aggregate purchase price of $500 million, exclusive of any brokerage commissions. The timing and amount of repurchases under the program will depend on a variety of factors, including the amount and timing of corporate development transactions, repayment of debt, restrictions under the Company's credit agreement, corporate and regulatory requirements, market conditions and the price of the Company's ordinary shares.

Term Loan B Repricing
The Company completed a repricing of the approximately $2.7 billion outstanding balance of its U.S. dollar term loans under its credit facility. The applicable margin above the Term Secured Overnight Financing Rate was reduced by 75 basis points (from 300 basis points to 225 basis points) and the credit spread adjustment of approximately 11 basis points has also been removed, resulting in anticipated interest savings of approximately $23 million on an annualized basis. All other terms are substantially unchanged.

Irrevocable Election of Settlement Method for the 2.000% Exchangeable Senior Notes due 2026
Jazz Investments I Limited (the “Issuer”), a subsidiary of Jazz Pharmaceuticals, announced that it provided written notice to the exchange agent, the trustee and the holders of its 2.000% Exchangeable Senior Notes due 2026 (the “2026 notes”) that it has irrevocably elected to fix the settlement method for exchanges of the 2026 notes to combination settlement with a specified cash amount equal to or in excess of $1,000. As a result, an exchanging holder will receive (i) up to $1,000 in cash per $1,000 principal amount of 2026 notes exchanged and (ii) cash, ordinary shares, or any combination thereof, at the Issuer’s election, in respect of the remainder, if any, of its exchange obligation in excess of $1,000 per $1,000 principal amount of 2026 notes exchanged.

Financial Highlights
Three Months Ended
June 30,		Six Months Ended
June 30,
(In thousands, except per share amounts)2024202320242023
Total revenues$1,023,825 $957,317 $1,925,808 $1,850,129 
GAAP net income$168,568 $104,438 $153,950 $173,858 
Non-GAAP adjusted net income$364,727 $325,129 $546,942 $610,390 
GAAP earnings per share$2.49 $1.52 $2.35 $2.55 
Non-GAAP adjusted EPS$5.30 $4.51 $7.98 $8.46 

GAAP net income for 2Q24 was $168.6 million, or $2.49 per diluted share, compared to $104.4 million, or $1.52 per diluted share, for 2Q23.
Non-GAAP adjusted net income for 2Q24 was $364.7 million, or $5.30 per diluted share, compared to $325.1 million, or $4.51 per diluted share, for 2Q23.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

4

Total Revenues
Three Months Ended
June 30,		Six Months Ended
June 30,
(In thousands)2024202320242023
Xywav$368,472 $326,564 $683,772 $604,325 
Xyrem62,180 159,769 126,412 337,899 
Epidiolex/Epidyolex247,102 202,226 445,818 391,135 
Sativex6,383 2,806 9,118 9,904 
Total Neuroscience684,137 691,365 1,265,120 1,343,263 
Rylaze/Enrylaze107,829 101,693 210,579 187,620 
Zepzelca81,047 70,348 156,147 137,529 
Defitelio/defibrotide 45,421 46,108 93,097 85,187 
Vyxeos43,012 34,056 75,035 70,756 
Total Oncology277,309 252,205 534,858 481,092 
Other2,698 3,417 6,268 6,851 
Product sales, net964,144 946,987 1,806,246 1,831,206 
High-sodium oxybate AG royalty revenue54,164 5,514 104,111 7,610 
Other royalty and contract revenues5,517 4,816 15,451 11,313 
Total revenues$1,023,825 $957,317 $1,925,808 $1,850,129 
Total revenues increased 7% in 2Q24 compared to the same period in 2023.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $738.3 million in 2Q24, an increase of 6% compared to $696.9 million in 2Q23, primarily due to increased high-sodium oxybate AG royalty revenue and increased Epidiolex/Epidyolex and Xywav net product sales, partially offset by decreased Xyrem revenues.
Oncology net product sales were $277.3 million in 2Q24, an increase of 10% compared to the same period in 2023, and included higher net product sales from Zepzelca and Rylaze/Enrylaze, which increased 15% and 6% to $81.0 million and $107.8 million, respectively.


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Operating Expenses and Effective Tax Rate
Three Months Ended
June 30,		Six Months Ended
June 30,
(In thousands, except percentages)2024202320242023
GAAP:
Cost of product sales$109,902$97,537$205,389$226,181
Gross margin88.6%89.7%88.6%87.6%
Selling, general and administrative$338,523$340,844$690,235$638,761
% of total revenues33.1%35.6%35.8%34.5%
Research and development$220,734$209,238$443,581$398,648
% of total revenues21.6%21.9%23.0%21.5%
Acquired in-process research and development$—$—$10,000$1,000
Income tax benefit1
$(30,653)$(24,323)$(18,984)$(39,647)
Effective tax rate 1
(22.2)%(29.7)%(13.9)%(29.0)%
_________________________
1.The GAAP income tax benefit decreased in the six months ended June 30, 2024, compared to the same period in 2023, due to the change in income mix across our jurisdictions and the impact of tax shortfalls from share-based compensation.


Three Months Ended
June 30,		Six Months Ended
June 30,
(In thousands, except percentages)2024202320242023
Non-GAAP adjusted:
Cost of product sales$72,413$65,994$136,561$130,722
Gross margin92.5%93.0%92.4%92.9%
Selling, general and administrative$303,386$276,871$614,885$537,386
% of total revenues29.6%28.9%31.9%29.0%
Research and development$203,463$192,019$407,478$365,937
% of total revenues19.9%20.1%21.2%19.8%
Acquired in-process research and development$—$—$10,000$1,000
Income tax expense1
$23,520$25,210$89,316$65,407
Effective tax rate1
6.1%7.2%14.0%9.6%
_________________________
1.The non-GAAP income tax expense increased in the six months ended June 30, 2024, compared to the same period in 2023, due to the change in income mix across our jurisdictions and the impact of tax shortfalls from share-based compensation.

Changes in operating expenses in 2Q24 over the prior year period are primarily due to the following:
•Cost of product sales on a GAAP basis increased in 2Q24 compared to the same period in 2023 due to higher acquisition accounting inventory fair value step-up expense and changes in product mix. Cost of product sales on a non-GAAP adjusted basis increased in 2Q24 compared to the same period in 2023, due to changes in product mix.
•Selling, general and administrative (SG&A) expenses on a GAAP basis decreased in 2Q24 compared to the same period in 2023 primarily due to costs related to program terminations incurred in 2Q23. SG&A expenses on a GAAP and on a non-GAAP adjusted basis included increased investment in our priority programs in 2Q24 as compared to the same period in 2023.
•Research and development (R&D) expenses on a GAAP and on a non-GAAP adjusted basis increased in 2Q24 compared to the same period in 2023 primarily due to higher costs related to zanidatamab, as well as our other key pipeline programs.

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Cash Flow and Balance Sheet
As of June 30, 2024, cash, cash equivalents and investments were $2.0 billion, and the outstanding principal balance of the Company’s long-term debt was $5.8 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500.0 million. For the six months ended June 30, 2024, the Company generated $598.6 million of cash from operations reflecting strong business performance and continued financial discipline.

2024 Financial Guidance
The Company is updating its full year 2024 financial guidance as follows:

(In millions)July 31, 2024May 1, 2024
Revenues$4,000 - $4,100$4,000 - $4,200
–Neuroscience (includes royalties from high-sodium oxybate AG)
$2,825 - $2,925$2,800 - $2,950
–Oncology$1,100 - $1,150$1,120 - $1,220

GAAP:
(In millions, except per share amounts and percentages)July 31, 2024May 1, 2024
Gross margin %89%89%
SG&A expenses$1,366 - $1,426$1,346 - $1,426
SG&A expenses as % of total revenues33% - 36%32% - 36%
R&D expenses$887 - $935$877 - $935
R&D expenses as % of total revenues22% - 23%21% - 23%
Effective tax rate(22)% - (3)%(22)% - (3)%
Net income$385 - $530$385 - $530
Net income per diluted share5
$6.00 - $8.00$5.80 - $7.70
Weighted-average ordinary shares used in per share calculations6771
Non-GAAP:
(In millions, except per share amounts and percentages)July 31, 2024May 1, 2024
Gross margin %
93%1,6
93%
SG&A expenses
$1,190 - $1,2302,6
$1,170 - $1,230
SG&A expenses as % of total revenues29% - 31%28% - 31%
R&D expenses
$810 - $8503,6
$800 - $850
R&D expenses as % of total revenues20% - 21%19% - 21%
Effective tax rate
10% - 12%4,6
10% - 13%
Net income
$1,275 - $1,3506
$1,275 - $1,350
Net income per diluted share5
$19.20 - $20.306
$18.15 - $19.35
Weighted-average ordinary shares used in per share calculations6771
___________________________
1.Excludes $125-$145 million of amortization of acquisition-related inventory fair value step-up and $17-$19 million of share-based compensation expense.
2.Excludes $176-$196 million of share-based compensation expense.
3.Excludes $77-$85 million of share-based compensation expense.
4.Excludes 32%-15% from the GAAP effective tax rate of (22)%-(3)% relating to the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income, resulting in a non-GAAP adjusted effective tax rate of 10%-12%.
5.Diluted EPS calculations for 2024 include an estimated 3.5 million shares related to the assumed conversion of the 2026 Notes, and the associated interest expense, net of tax, add-back to net income of $11 million and $10 million, on a GAAP and on a non-GAAP adjusted basis, respectively, under the "if converted" method. In July 2024, we made the irrevocable
7

election to net share settle our 2026 Notes. This election is expected to increase our full-year net income per diluted share guidance by $0.10 to $0.20 per share, on a GAAP basis, and $0.65 to $0.75 per share, on a non-GAAP adjusted basis, as a result of an estimated decrease in the weighted-average outstanding shares of 2.9 million shares.
6.See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of GAAP to non-GAAP Adjusted 2024 Net Income Guidance" at the end of this press release.


Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. IST) to provide a business and financial update and discuss its 2024 second quarter results.
Audio webcast/conference call:
U.S. Dial-In Number: +1 800 715 9871
Ireland Dial-In Number: +353 1800 943 926
Additional global dial-in numbers are available here.
Passcode: 9124647

Interested parties may access the live audio webcast 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.
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About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. 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 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 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 (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
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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.

Caution Concerning Forward-Looking Statements
This 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 2024 financial guidance and the Company’s expectations related thereto and anticipated catalysts; expectations that Xywav will remain the oxybate of choice; expectations of high-sodium oxybate AG royalty revenue in 2024; the ability to generate long-term sustainable growth and value; the Company’s advancement of pipeline programs and the timing of development activities, regulatory activities and submissions related thereto; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: expectations of near-term, late-stage pipeline catalysts through 2025, top-line data from a Phase 2 trial of suvecaltamide in PDT, top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA, top-line data from a Phase 3 trial of Epidyolex in DS, LGS and TSC in Japan and top-line PFS data from a Phase 3 trial of Zepzelca in 1L SCLC; and the Company’s development, regulatory and commercialization strategy, including the Company's expectations to executing multiple Epidyolex launches through 2024; 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; 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; planned or anticipated regulatory submissions and filings, and the anticipated timing thereof; potential regulatory approvals; 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 and Epidiolex/Epidyolex and other marketed products; the introduction of new products into the U.S. market that compete with, or otherwise disrupt the market for the Company's products and product candidates; 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; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company’s business operations and financial results; geopolitical events, including the conflict between Russia and Ukraine and related sanctions; macroeconomic conditions, including global financial markets, rising interest rates and inflation and recent and potential banking disruptions; 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 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; complying with applicable U.S. and non-U.S. regulatory requirements, including those governing the research, development, manufacturing and distribution of controlled substances;
10

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 corporate development transactions and 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; the timing and availability of alternative investment opportunities; 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' Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2023, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, 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.
11

JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended
June 30,		Six Months Ended
June 30,
2024202320242023
Revenues:
Product sales, net$964,144 $946,987 $1,806,246 $1,831,206 
Royalties and contract revenues59,681 10,330 119,562 18,923 
Total revenues1,023,825 957,317 1,925,808 1,850,129 
Operating expenses:
Cost of product sales (excluding amortization of acquired developed technologies)109,902 97,537 205,389 226,181 
Selling, general and administrative338,523 340,844 690,235 638,761 
Research and development220,734 209,238 443,581 398,648 
Intangible asset amortization155,223 152,062 310,953 301,848 
Acquired in-process research and development— — 10,000 1,000 
Total operating expenses824,382 799,681 1,660,158 1,566,438 
Income from operations199,443 157,636 265,650 283,691 
Interest expense, net(62,023)(73,470)(128,139)(147,617)
Foreign exchange gain (loss)507 (2,382)(1,186)811 
Income before income tax benefit and equity in loss of investees137,927 81,784 136,325 136,885 
Income tax benefit(30,653)(24,323)(18,984)(39,647)
Equity in loss of investees12 1,669 1,359 2,674 
Net income$168,568 $104,438 $153,950 $173,858 
Net income per ordinary share:
Basic$2.68 $1.63 $2.45 $2.73 
Diluted$2.49 $1.52 $2.35 $2.55 
Weighted-average ordinary shares used in per share calculations - basic62,882 63,991 62,710 63,744 
Weighted-average ordinary shares used in per share calculations - diluted69,625 73,540 69,684 73,657 






12

JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
June 30,
2024		December 31,
2023
ASSETS
Current assets:
Cash and cash equivalents$1,355,802 $1,506,310 
Investments625,000 120,000 
Accounts receivable, net of allowances698,037 705,794 
Inventories542,555 597,039 
Prepaid expenses134,421 185,476 
Other current assets325,851 320,809 
Total current assets3,681,666 3,435,428 
Property, plant and equipment, net169,281 169,646 
Operating lease assets73,145 65,340 
Intangible assets, net5,079,462 5,418,039 
Goodwill1,735,931 1,753,130 
Deferred tax assets, net545,222 477,834 
Deferred financing costs5,736 6,478 
Other non-current assets71,425 67,464 
Total assets$11,361,868 $11,393,359 
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable$97,096 $102,750 
Accrued liabilities800,993 793,914 
Current portion of long-term debt605,798 604,954 
Income taxes payable52,138 35,074 
Total current liabilities1,556,025 1,536,692 
Long-term debt, less current portion5,100,983 5,107,988 
Operating lease liabilities, less current portion67,617 59,225 
Deferred tax liabilities, net775,228 847,706 
Other non-current liabilities99,416 104,751 
Total shareholders’ equity3,762,599 3,736,997 
Total liabilities and shareholders’ equity$11,361,868 $11,393,359 

JAZZ PHARMACEUTICALS PLC
SUMMARY OF CASH FLOWS
(In thousands)
(Unaudited)
 Six Months Ended
June 30,
 20242023
Net cash provided by operating activities$598,581 $617,473 
Net cash used in investing activities(528,995)(90,561)
Net cash used in financing activities(217,637)(126,455)
Effect of exchange rates on cash and cash equivalents(2,457)365 
Net increase (decrease) in cash and cash equivalents$(150,508)$400,822 
13

JAZZ PHARMACEUTICALS PLC
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended
June 30,		Six Months Ended
June 30,
2024202320242023
Net Income
Diluted EPS1
Net Income
Diluted EPS1
Net Income
Diluted EPS1
Net Income
Diluted EPS1
GAAP reported$168,568 $2.49 $104,438 $1.52 $153,950 $2.35 $173,858 $2.55 
Intangible asset amortization155,223 2.23 152,062 2.07 310,953 4.46 301,848 4.10 
Share-based compensation expense56,654 0.81 61,433 0.84 118,095 1.69 117,785 1.60 
Acquisition accounting inventory fair value step-up33,243 0.48 27,814 0.38 62,186 0.89 88,272 1.20 
Other costs2
— — 23,488 0.32 — — 23,488 0.32 
Non-cash interest expense3
5,212 0.07 5,427 0.07 10,058 0.14 10,193 0.14 
Income tax effect of above adjustments(54,173)(0.77)(49,533)(0.67)(108,300)(1.54)(105,054)(1.43)
Effect of assumed conversion of Exchangeable Senior Notes1
— (0.01)— (0.02)— (0.01)— (0.02)
Non-GAAP adjusted$364,727 $5.30 $325,129 $4.51 $546,942 $7.98 $610,390 $8.46 
Weighted-average ordinary shares used in diluted per share calculations - GAAP and non-GAAP1
69,625 73,540 69,684 73,657 
________________________________________________
Explanation of Adjustments and Certain Line Items:
1.Diluted EPS was calculated using the "if-converted" method in relation to the 1.50% exchangeable senior notes due 2024, or the 2024 Notes, and the 2026 Notes, which we refer to collectively as the Exchangeable Senior Notes. In August 2023, we made an irrevocable election to fix the settlement method for exchange of the 2024 Notes to a combination of cash and ordinary shares of the Company with a specified cash amount per $1,000 principal amount of the 2024 Notes of $1,000. As a result, the assumed issuance of ordinary shares upon exchange of the 2024 Notes has only been included in the calculation of diluted net income per ordinary share, on a GAAP and on a non-GAAP adjusted basis, in the three and six months ended June 30, 2023. Net income per diluted share, on a GAAP and non-GAAP adjusted basis, for the three and six months ended June 30, 2024 included 6.4 million shares related to the assumed conversion of the 2026 Notes and the associated interest expense, net of tax, add-back to GAAP reported net income of $4.9 million and $9.7 million, respectively, and the associated interest expense, net of tax, add-back to non-GAAP adjusted net income of $4.4 million and $8.8 million, respectively. Net income per diluted share, on a GAAP and non-GAAP adjusted basis, for the three and six months ended June 30, 2023 included 9.0 million shares related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense, net of tax, add-back to GAAP reported net income of $7.1 million and $14.0 million, respectively, and the associated interest expense, net of tax, add-back to non-GAAP adjusted net income of $6.3 million and $12.6 million, respectively.
2.Costs related to program terminations.
3.Non-cash interest expense associated with debt issuance costs.
14

JAZZ PHARMACEUTICALS PLC
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
CERTAIN LINE ITEMS - FOR THE THREE MONTHS ENDED JUNE 30, 2024 and 2023
(In thousands, except percentages)
(Unaudited)

Three months ended June 30, 2024
Cost of product salesGross marginSelling, general and administrativeResearch and developmentIntangible asset amortizationInterest expense, netIncome tax expense (benefit)
GAAP Reported$109,902 88.6 %$338,523 $220,734 $155,223 $62,023 $(30,653)
Non-GAAP Adjustments:
Intangible asset amortization— — — — (155,223)— — 
Share-based compensation expense(4,246)0.4 (35,137)(17,271)— — — 
Acquisition accounting inventory fair value step-up(33,243)3.5 — — — — — 
Non-cash interest expense— — — — — (5,212)— 
Income tax effect of above adjustments— — — — — — 54,173 
Total of non-GAAP adjustments(37,489)3.9 (35,137)(17,271)(155,223)(5,212)54,173 
Non-GAAP Adjusted$72,413 92.5 %$303,386 $203,463 $— $56,811 $23,520 


Three months ended June 30, 2023
Cost of product salesGross marginSelling, general and administrativeResearch and developmentIntangible asset amortizationInterest expense, netIncome tax expense (benefit)
GAAP Reported$97,537 89.7 %$340,844 $209,238 $152,062 $73,470 $(24,323)
Non-GAAP Adjustments:
Intangible asset amortization— — — — (152,062)— — 
Share-based compensation expense(3,729)0.3 (40,485)(17,219)— — — 
Other costs— — (23,488)— — — — 
Non-cash interest expense— — — — — (5,427)— 
Acquisition accounting inventory fair value step-up(27,814)3.0 — — — — — 
Income tax effect of above adjustments— — — — — — 49,533 
Total of non-GAAP adjustments(31,543)3.3 (63,973)(17,219)(152,062)(5,427)49,533 
Non-GAAP Adjusted$65,994 93.0 %$276,871 $192,019 $— $68,043 $25,210 

15

JAZZ PHARMACEUTICALS PLC
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
CERTAIN LINE ITEMS - FOR THE SIX MONTHS ENDED JUNE 30, 2024 and 2023
(In thousands, except percentages)
(Unaudited)

Six months ended June 30, 2024
Cost of product salesGross marginSelling, general and administrativeResearch and developmentIntangible asset amortizationAcquired IPR&DInterest expense, netIncome tax expense (benefit)
GAAP Reported$205,389 88.6 %$690,235 $443,581 $310,953 $10,000 $128,139 $(18,984)
Non-GAAP Adjustments:
Intangible asset amortization— — — — (310,953)— — — 
Share-based compensation expense(6,642)0.4 (75,350)(36,103)— — — — 
Non-cash interest expense— — — — — — (10,058)— 
Acquisition accounting inventory fair value step-up(62,186)3.4 — — — — — — 
Income tax effect of above adjustments— — — — — — — 108,300 
Total of non-GAAP adjustments(68,828)3.8 (75,350)(36,103)(310,953)— (10,058)108,300 
Non-GAAP Adjusted$136,561 92.4 %$614,885 $407,478 $— $10,000 $118,081 $89,316 

Six months ended June 30, 2023
Cost of product salesGross marginSelling, general and administrativeResearch and developmentIntangible asset amortizationAcquired IPR&DInterest expense, netIncome tax expense (benefit)
GAAP Reported$226,181 87.6 %$638,761 $398,648 $301,848 $1,000 $147,617 $(39,647)
Non-GAAP Adjustments:
Intangible asset amortization— — — — (301,848)— — — 
Share-based compensation expense(7,187)0.4 (77,887)(32,711)— — — — 
Other costs— — (23,488)— — — — — 
Non-cash interest expense— — — — — — (10,193)— 
Acquisition accounting inventory fair value step-up(88,272)4.9 — — — — — — 
Income tax effect of above adjustments— — — — — — — 105,054 
Total of non-GAAP adjustments(95,459)5.3 (101,375)(32,711)(301,848)— (10,193)105,054 
Non-GAAP Adjusted$130,722 92.9 %$537,386 $365,937 $— $1,000 $137,424 $65,407 

16

JAZZ PHARMACEUTICALS PLC
RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2024 NET INCOME AND DILUTED EPS GUIDANCE
(In millions, except per share amounts)
(Unaudited)
Net IncomeDiluted EPS
GAAP guidance$385 - $530$6.00 - $8.00
Intangible asset amortization605 - 6458.95 - 9.70
Acquisition accounting inventory fair value step-up125 - 1451.85 - 2.20
Share-based compensation expense270 - 3004.00 - 4.50
Non-cash interest expense20 - 300.30 - 0.45
Income tax effect of above adjustments(205) - (225)(3.05) - (3.40)
Non-GAAP guidance$1,275 - $1,350$19.20 - $20.30
Weighted-average ordinary shares used in per share calculations - GAAP and non-GAAP67




Contacts:

Investors:
Andrea N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717

Media:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
17
v3.24.2
Cover
Jul. 31, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Jul. 31, 2024
Entity Registrant Name Jazz Pharmaceuticals plc
Entity Incorporation, State or Country Code L2
Entity File Number 001-33500
Entity Tax Identification Number 98-1032470
Entity Address, Address Line One Fifth Floor, Waterloo Exchange,
Entity Address, Address Line Two Waterloo Road,
Entity Address, City or Town Dublin 4,
Entity Address, Country IE
Entity Address, Postal Zip Code D04 E5W7
Country Region 353
City Area Code 1
Local Phone Number 634-7800
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Ordinary shares, nominal value $0.0001 per share
Trading Symbol JAZZ
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001232524
Amendment Flag false
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