Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2024 Financial Results and Provides 2025 Financial Guidance

- Record total revenues of $4.1 billion in 2024 and $1.1 billion in 4Q24 -
- Xywav(®) and Epidiolex(®) revenues grew 16% and 15% year-over-year, respectively, in 2024 -
- Oncology revenues grew 9% year-over-year in 2024, surpassed $1.1 billion -
- Ziihera(® )approved in 2L HER2+ (IHC3+) BTC; first sales achieved in December 2024 -
- 2025 guidance reflects continued top- and bottom-line growth -

DUBLIN, Feb. 25, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the full year and fourth quarter of 2024 and provided guidance for 2025.

"2024 was another strong year as our proven team delivered significant top- and bottom-line growth along with record total revenues of over $4 billion. Our diversified portfolio spanning sleep(1), epilepsy and oncology, with each annualizing at over $1 billion, continued to drive growth," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. "We are pleased with the continued progress of our late-stage pipeline assets, including the recent launch of Ziihera in 2L HER2+ (IHC3+) BTC, upcoming top-line data readout from the HERIZON-GEA-01 trial in 1L GEA, which we now expect in the second half of 2025, and highly encouraging results from the Phase 3 IMforte trial, which we expect to submit as part of an sNDA for Zepzelca(®) in 1L ES-SCLC in the first half of 2025."

Mr. Cozadd continued, "The strength of our 2024 results reinforces our confidence that Jazz is well-positioned to deliver top- and bottom-line growth in 2025 and drive long-term shareholder value. Our focus remains on disciplined capital allocation, which we expect to drive growth of our diversified commercial portfolio, continue advancement of our pipeline and provide flexibility to remain active in corporate development."

Key Highlights

    --  Total revenues in 2024 grew 6% year-over-year; generated over $1.4
        billion in cash from operations.
    --  Zanidatamab:
        --  Received U.S. FDA approval of and launched Ziihera in 2L HER2+
            (IHC3+) BTC.
        --  Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in
            2H25.
    --  On track to submit an sNDA in 1H25 for Zepzelca in combination with
        Tecentriq(® )(atezolizumab) as maintenance therapy in 1L ES-SCLC based
        on the potentially practice-changing results from the Phase 3 IMforte
        trial.
    --  Top- and bottom-line growth expected in 2025; 2025 total revenue
        guidance of $4.15 - $4.40 billion, representing 5% growth at the
        midpoint.
        --  Total revenue guidance is underpinned by expected continued growth
            in diversified commercial portfolio spanning sleep(1), epilepsy and
            oncology.


     
     ________________________________



     
     (1) Total sleep revenue includes: Xywav, branded Xyrem and high-sodium oxybate authorized generic royalty revenues.

Business Updates

Commercial Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:

    --  Xywav net product sales increased 16% to $1,473.2 million in 2024 and
        increased 19% to $401.0 million in 4Q24 compared to the same periods in
        2023.
    --  Meaningful Xywav net patient adds in 4Q24 (approximately 525 patients)
        with approximately 14,150 active Xywav patients exiting 4Q24, comprised
        of:
        --  Approximately 10,250 narcolepsy patients.
        --  Approximately 3,900 idiopathic hypersomnia (IH) patients, with 350
            net patient adds.
    --  Xywav is the only low-sodium oxybate, the #1 branded treatment for
        narcolepsy(2) and the only FDA-approved therapy to treat IH.

Xyrem(®) (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:

    --  Xyrem net product sales decreased 59% to $233.8 million in 2024 and
        decreased 54% to $49.3 million in 4Q24 compared to the same periods in
        2023.
    --  Royalties from high-sodium oxybate AGs increased by $141.7 million to
        $217.6 million in 2024 and increased $15.9 million to $55.3 million in
        4Q24, compared to the same periods in 2023.

Epidiolex/Epidyolex(®) (cannabidiol):

    --  Epidiolex/Epidyolex net product sales increased 15% to $972.4 million in
        2024 and increased 14% to $275.0 million in 4Q24 compared to the same
        periods in 2023.
    --  Outside of the U.S., Epidyolex is approved in more than 35 countries.
    --  Presented data at the American Epilepsy Society 2024 Annual meeting,
        including novel findings from the BECOME-LTC, BECOME-TSC and EpiCom
        studies, demonstrating the meaningful impact of Epidiolex in the
        treatment of patients with rare epilepsies including benefits of
        Epidiolex's benefits beyond seizure control.
    --  Remain confident in achieving blockbuster status for Epidiolex/Epidyolex
        in 2025.

Rylaze(®)/Enrylaze(®) (asparaginase erwinia chrysanthemi (recombinant)-rywn):

    --  Rylaze/Enrylaze net product sales increased 4% to $410.8 million in 2024
        and were in line in 4Q24 compared to the same periods in 2023 despite
        headwinds from Children's Oncology Group (COG) protocol changes that
        impacted timing of asparaginase administration.
    --  The temporary impact to Rylaze net product sales due to previously
        announced COG pediatric acute lymphoblastic leukemia (ALL) protocol
        updates is still expected to normalize by early 2025.

Zepzelca (lurbinectedin):

    --  Zepzelca net product sales increased 11% to $320.3 million in 2024 and
        increased 6% to $78.3 million in 4Q24 compared to the same periods in
        2023.
    --  Based on potentially practice-changing positive results from the Phase 3
        IMforte trial, the Company plans to submit a supplemental New Drug
        Application (sNDA) for Zepzelca's use in combination with Tecentriq as
        maintenance therapy in first-line (1L) extensive-stage (ES) small cell
        lung cancer (SCLC) in 1H25.

Ziihera (zanidatamab-hrii):

    --  Ziihera net product sales were $1.1 million in 2024 and 4Q24 after the
        initial product launch and availability in December of 2024 following
        FDA approval in November.
    --  Initial positive reception by prescribers with the first patient treated
        in December.
    --  Ziihera added to National Comprehensive Cancer Network(® )(NCCN(®))
        Clinical Practice Guidelines in Oncology.
    --  Ziihera added to European Society for Medical Oncology(®) (ESMO(®))
        Clinical Practice Guidelines for Biliary Tract Cancers.


              __________________________



              
                (2) Based on 4Q24 Xywav net product sales.

Key Pipeline Highlights

Zanidatamab:

    --  In 4Q24, announced U.S. FDA granted accelerated approval of Ziihera
        (zanidatamab-hrii) for the treatment of adults with previously treated,
        unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer
        (BTC).
    --  The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L
        gastroesophageal adenocarcinoma (GEA), is expected to read out in 2H25
        based on an updated assessment of progression events. Recruitment for
        the trial remains on track.
    --  Data presented at the San Antonio Breast Cancer Symposium 2024 continued
        to underscore zanidatamab's potential for patients previously treated
        with trastuzumab deruxtecan (T-DXd) and showcased the advancement of our
        clinical program in breast cancer.
    --  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
        T-DXd treatment continues to enroll patients.
    --  First patient enrolled in the Phase 2 pan-tumor trial to evaluate
        HER2-positive solid tumors.

Financial Highlights


                                                            Three Months Ended                       Year Ended

                                                            December 31,                       December 31,



     (In thousands, except per share amounts)       2024       2023               2024       2023



     Total revenues                           $1,088,173 $1,011,935         $4,068,950 $3,834,204



     GAAP net income                            $191,115    $94,154           $560,120   $414,832



     Non-GAAP adjusted net income               $405,863   $345,286         $1,369,729 $1,295,824



     GAAP earnings per share                       $3.11      $1.42              $8.65      $6.10



     Non-GAAP adjusted EPS                         $6.60      $5.02             $20.90     $18.29

GAAP net income for 2024 was $560.1 million, or $8.65 per diluted share, compared to $414.8 million, or $6.10 per diluted share, for 2023. GAAP net income for 4Q24 was $191.1 million, or $3.11 per diluted share, compared to a GAAP net income of $94.2 million, or $1.42 per diluted share, for 4Q23.

Non-GAAP adjusted net income for 2024 was $1,369.7 million, or $20.90 per diluted share, compared to $1,295.8 million, or $18.29 per diluted share, for 2023. Non-GAAP adjusted net income for 4Q24 was $405.9 million, or $6.60 per diluted share, compared to $345.3 million, or $5.02 per diluted share, for 4Q23.

Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues


                                                           Three Months Ended                      Year Ended

                                                           December 31,                      December 31,



     (In thousands)                               2024       2023                2024       2023



     Xywav                                    $400,964   $337,019          $1,473,202 $1,272,977



     Xyrem                                      49,290    106,721             233,816    569,730



     Epidiolex/Epidyolex                       275,047    240,622             972,423    845,468



     Sativex                                     5,173      5,137              18,877     19,668



     Total Neuroscience                        730,474    689,499           2,698,318  2,707,843



     Rylaze/Enrylaze                           101,487    101,747             410,846    394,226



     Zepzelca                                   78,328     74,010             320,318    289,533



     Defitelio/defibrotide                      57,650     51,083             216,565    184,000



     Vyxeos                                     53,247     46,912             162,595    147,495



     Ziihera                                     1,051                         1,051



     Total Oncology                            291,763    273,752           1,111,375  1,015,254



     Other                                       2,974      4,088              11,471     13,846



     Product sales, net                      1,025,211    967,339           3,821,164  3,736,943



     High-sodium oxybate AG royalty revenue     55,307     39,387             217,575     75,918



     Other royalty and contract revenues         7,655      5,209              30,211     21,343



     Total revenues                         $1,088,173 $1,011,935          $4,068,950 $3,834,204

Total revenues increased 6% in 2024 and 8% in 4Q24 compared to the same periods in 2023.

Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $2,915.9 million in 2024, an increase of 5% compared to $2,783.8 million in 2023 and $785.8 million in 4Q24, an increase of 8% compared to $728.9 million in 4Q23. The increase in 2024 and 4Q24 was due to higher Xywav and Epidiolex/Epidyolex net product sales together with increased high-sodium oxybate AG royalty revenue, partially offset by decreased Xyrem net product sales.

Oncology net product sales were $1,111.4 million in 2024, an increase of 9% compared to $1,015.3 million in 2023 and $291.8 million in 4Q24, an increase of 7% compared to $273.8 million in 2023, and included higher net product sales from Defitelio/defibrotide which increased 18% in 2024 and 13% in 4Q24 and Zepzelca which increased 11% in 2024 and 6% in 4Q24. In 4Q24, Rylaze net product sales were negatively impacted due to an update to the COG pediatric treatment protocols for ALL, which impacts the timing of asparaginase administration.

Operating Expenses and Effective Tax Rate


                                                              Three Months Ended                   Year Ended

                                                                 December 31,                      December 31,



     (In thousands, except percentages)                    2024                  2023        2024            2023



     GAAP:



     Cost of product sales                             $128,713              $107,243    $445,713        $435,577



     
                Gross margin                           87.4 %               88.9 %     88.3 %         88.3 %



     Selling, general and administrative               $369,287              $396,034  $1,385,294      $1,343,105



     
                % of total revenues                    33.9 %               39.1 %     34.0 %         35.0 %



     Research and development                          $240,500              $216,608    $884,000        $849,658



     
                % of total revenues                    22.1 %               21.4 %     21.7 %         22.2 %



     Acquired in-process research and development 
     $         -              $18,000     $10,000         $19,000



     Income tax benefit1                              $(57,912)            $(33,089)  $(91,429)     $(119,912)



     
                Effective tax rate 1                 (43.5) %             (53.8) %   (19.4) %       (40.2) %


     _________________________



     1.                        The GAAP income tax benefit increased in the three months ended December 31, 2024, compared to the same period in 2023, primarily due to patent box benefits recognized in the period and decreased in
                                 the year ended December 31, 2024, compared to the same period in 2023, primarily due to the change in income mix across our jurisdictions, partially offset by patent box benefits.


                                                              Three Months Ended                         Year Ended
                                                     
          December 31,               
              December 31,



     (In thousands, except percentages)                    2024                  2023         2024                  2023



     Non-GAAP adjusted:



     Cost of product sales                              $86,492               $71,238     $295,897              $269,079



     
                Gross margin                           91.6 %               92.6 %      92.3 %               92.8 %



     Selling, general and administrative               $323,167              $300,520   $1,226,724            $1,110,948



     
                % of total revenues                    29.7 %               29.7 %      30.1 %               29.0 %



     Research and development                          $220,857              $201,107     $809,327              $784,811



     
                % of total revenues                    20.3 %               19.9 %      19.9 %               20.5 %



     Acquired in-process research and development 
      $        -              $18,000      $10,000               $19,000



     Income tax expense(1)                                 $308               $20,475     $131,307               $93,260



     
                Effective tax rate(1)                   0.1 %                5.6 %       8.7 %                6.7 %


     _________________________



     1.                        The non-GAAP income tax expense decreased in the three months ended December 31, 2024, compared to the same period in 2023, primarily due to patent box benefits recognized in the period and increased
                                 in the year ended December 31, 2024, compared to the same period in 2023, due to the change in income mix across our jurisdictions, partially offset by patent box benefits.

Changes in operating expenses in 2024 and 4Q24 over the prior year periods are primarily due to the following:

    --  Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased
        in 2024 and 4Q24, compared to the same periods in 2023, primarily due to
        higher inventory provisions and changes in product mix. Cost of product
        sales, on a GAAP basis, included lower acquisition accounting inventory
        fair value step up expense in 2024 as compared to the previous period.
    --  Selling, general and administrative (SG&A) expenses, on a GAAP and
        non-GAAP adjusted basis, increased in 2024 compared to the same period
        in 2023, primarily due to higher compensation-related expenses,
        increased investment in sales and marketing and increased litigation
        costs, partially offset, on a GAAP basis, by costs related to impairment
        of facility assets and program terminations in 2023. SG&A expenses, on a
        GAAP basis, decreased in 4Q24 compared to the same period in 2023,
        primarily due to the impairment of facility assets in 4Q23, partially
        offset by higher compensation related expenses. SG&A expenses, on a
        non-GAAP adjusted basis, increased in 4Q24 primarily due to higher
        compensation-related expenses.
    --  Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted
        basis, increased in 2024 and 4Q24, compared to the same period in 2023,
        primarily due to increased compensation related expenses and clinical
        study costs primarily related to zanidatamab, partially offset by
        reduced costs related to JZP150 and JZP385.
    --  Acquired in-process research and development (IPR&D) expense in 2024, on
        a GAAP and non-GAAP adjusted basis, related to an upfront payment made
        in connection with our asset purchase and collaboration agreement with
        Redx Pharma plc. Acquired IPR&D expense in 2023, on a GAAP and non-GAAP
        adjusted basis, primarily related to an upfront payment made in
        connection with our licensing and collaboration agreement with Autifony
        Therapeutics Limited.

Cash Flow and Balance Sheet

As of December 31, 2024, cash, cash equivalents and investments were $3.0 billion, and the outstanding principal balance of the Company's long-term debt was $6.2 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $885.0 million. For the year ended December 31, 2024, the Company generated $1.4 billion of cash from operations reflecting strong business performance and continued financial discipline. In January 2025, the Company made a voluntary prepayment of $750.0 million principal amount on the Term Loan B.

2025 Financial Guidance

Jazz Pharmaceutical's full year 2025 financial guidance is as follows:



              (In millions)                                                                                   Guidance



              Total Revenues                                                                       
       $4,150 - $4,400





              (In millions, except per share amounts and percentages)                         GAAP               Non-GAAP


    Gross margin %                                                                           88 %                 92%1,6



              SG&A expenses                                                   
        $1,404 - $1,483 
       $1,250 - $1,3102,6



              R&D expenses                                                       
         $792 - $851   
         $720 - $7703,6



              Effective tax rate                                                        (5)% - 10%           13% -15%4,6



              Net income                                                         
         $560 - $720 
       $1,400 - $1,5005,6



              Net income per diluted share                                     
        $9.15 - $11.50 
       $22.50 - $24.005,6



              Weighted-average ordinary shares used in per share calculations               62 -63                 62 -63


     ___________________________



     1.                          
     Excludes $135-$155 million of amortization of acquisition-related inventory fair value step-up and $14-$16 million of share-based compensation expense.



     2.                          
     Excludes $154-$173 million of share-based compensation expense.



     3.                          
     Excludes $72-$81 million of share-based compensation expense.



     4.                            Excludes 18%-5% from the GAAP effective tax rate of (5)%-10% 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 13%-15%.



     5.                            Beginning with the 2025 financial guidance presented in this press release, the company will no longer include an adjustment for non-cash interest expense in its non-GAAP adjusted financial measures.
                                     Accordingly, any historical non-GAAP adjusted financial measures presented by the company in the future, beginning with the company's earnings press release for the first quarter of 2025, will not
                                     include an adjustment for non-cash interest expense. Any comparative historical periods presented will also be updated to reflect this change beginning with the company's earnings press release for
                                     the first quarter of 2025. However, for purposes of comparability with the company's prior presentations of non-GAAP financial measures, the historical non-GAAP financial measures presented in this
                                     press release include an adjustment for non-cash interest expense.



     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 2025 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. GMT) to provide a business and financial update and discuss its 2024 full year and 4Q24 results and 2025 guidance.

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: 5080203

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.

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. In this regard, the company has determined that, beginning with the 2025 financial guidance presented in this press release, it will no longer include an adjustment for non-cash interest expense in its non-GAAP adjusted financial measures. Accordingly, any historical non-GAAP adjusted financial measures presented by the company in the future, beginning with the company's earnings press release for the first quarter of 2025, will not include an adjustment for non-cash interest expense. Any comparative historical periods presented will also be updated to reflect this change beginning with the company's earnings press release for the first quarter of 2025. However, for purposes of comparability with the company's prior presentations of non-GAAP financial measures, the historical non-GAAP financial measures presented in this press release include an adjustment for non-cash interest expense. 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 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 2025 financial guidance and the Company's expectations related thereto and anticipated catalysts; expectations that Xywav will remain the #1 branded treatment for narcolepsy and Epidiolex achieving blockbuster status in 2025; the ability to generate growth and long-term shareholder value; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities and submissions related thereto, including plans to submit a sNDA for Zepzelca in 1L ES-SCLC in the first half of 2025; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA; and the Company's development, regulatory and commercialization strategy; 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, including Zepzelca's potential to change current practice in 1L ES-SCLC; 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 international tariffs and 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; 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, 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.


                                                                
           
                JAZZ PHARMACEUTICALS PLC
                                                            
             CONDENSED CONSOLIDATED STATEMENTS OF INCOME
                                                              
             (In thousands, except per share amounts)
                                                                         
                (Unaudited)




                                                                                                                                    Three Months Ended                            Year Ended
                                                                                                                    
            December 31,               
              December 31,


                                                                                                                        2024              2023                2024                2023



              Revenues:



              Product sales, net                                                                                 $1,025,211          $967,339          $3,821,164          $3,736,943



              Royalties and contract revenues                                                                        62,962            44,596             247,786              97,261



              Total revenues                                                                                      1,088,173         1,011,935           4,068,950           3,834,204



              Operating expenses:



              Cost of product sales (excluding amortization of                                                      128,713           107,243             445,713             435,577
    acquired developed technologies)



              Selling, general and administrative                                                                   369,287           396,034           1,385,294           1,343,105



              Research and development                                                                              240,500           216,608             884,000             849,658



              Intangible asset amortization                                                                         158,903           151,553             627,313             608,284



              Acquired in-process research and development                                                                -           18,000              10,000              19,000



              Total operating expenses                                                                              897,403           889,438           3,352,320           3,255,624



              Income from operations                                                                                190,770           122,497             716,630             578,580



              Interest expense, net                                                                                (51,256)         (70,324)          (238,097)          (289,438)



              Foreign exchange gain (loss)                                                                          (6,295)            9,353             (8,182)              8,787



              Income before income tax benefit and equity in loss of                                                133,219            61,526             470,351             297,929
    investees



              Income tax benefit                                                                                   (57,912)         (33,089)           (91,429)          (119,912)



              Equity in loss of investees                                                                                16               461               1,660               3,009



              Net income                                                                                           $191,115           $94,154            $560,120            $414,832





              Net income per ordinary share:



              Basic                                                                                                   $3.16             $1.50               $9.06               $6.55



              Diluted                                                                                                 $3.11             $1.42               $8.65               $6.10



              Weighted-average ordinary shares used in per share                                                     60,538            62,578              61,838              63,291
    calculations - basic



              Weighted-average ordinary shares used in per share                                                     61,503            69,673              66,007              72,066
    calculations - diluted


                                        
              
                JAZZ PHARMACEUTICALS PLC
                                       
                CONDENSED CONSOLIDATED BALANCE SHEETS
                                                  
                (In thousands)
                                                    
                (Unaudited)




                                                                                             December 31, December 31,
                                                                                                     2024          2023


                                               
              
                ASSETS



     Current assets:



     Cash and cash equivalents                                                                $2,412,864    $1,506,310



     Investments                                                                                 580,000       120,000



     Accounts receivable, net of allowances                                                      716,765       705,794



     Inventories                                                                                 480,445       597,039



     Prepaid expenses                                                                            177,411       185,476



     Other current assets                                                                        261,543       320,809



     Total current assets                                                                      4,629,028     3,435,428



     Property, plant and equipment, net                                                          173,413       169,646



     Operating lease assets                                                                       53,582        65,340



     Intangible assets, net                                                                    4,755,695     5,418,039



     Goodwill                                                                                  1,716,323     1,753,130



     Deferred tax assets, net                                                                    560,245       477,834



     Deferred financing costs                                                                      9,489         6,478



     Other non-current assets                                                                    114,482        67,464



     Total assets                                                                            $12,012,257   $11,393,359


                                
              
                LIABILITIES AND SHAREHOLDERS' EQUITY



     Current liabilities:



     Accounts payable                                                                            $77,869      $102,750



     Accrued liabilities                                                                         910,947       793,914



     Current portion of long-term debt                                                            31,000       604,954



     Income taxes payable                                                                         18,757        35,074



     Total current liabilities                                                                 1,038,573     1,536,692



     Long-term debt, less current portion                                                      6,077,640     5,107,988



     Operating lease liabilities, less current portion                                            38,938        59,225



     Deferred tax liabilities, net                                                               676,736       847,706



     Other non-current liabilities                                                                86,614       104,751



     Total shareholders' equity                                                                4,093,756     3,736,997



     Total liabilities and shareholders' equity                                              $12,012,257   $11,393,359


                                     
              
                JAZZ PHARMACEUTICALS PLC
                                            
                SUMMARY OF CASH FLOWS
                                                
                (In thousands)
                                                 
                (Unaudited)




                                                                                                       Year Ended
                                                                                        
            December 31,


                                                                                            2024              2023



     Net cash provided by operating activities                                       $1,395,908        $1,092,007



     Net cash used in investing activities                                            (508,195)        (163,062)



     Net cash provided by (used in) financing activities                                 20,516         (305,254)



     Effect of exchange rates on cash and cash equivalents                              (1,675)            1,137



     Net increase in cash and cash equivalents                                         $906,554          $624,828


                                                                               
              
                JAZZ PHARMACEUTICALS PLC
                                                                      
          RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
                                                                            
                (In thousands, except per share amounts)
                                                                                           
                (Unaudited)




                                                                        
           
                Three Months Ended                                                                         
       
                Year Ended
                                                                              
                December 31,                                                                                   
            December 31,


                                                                                     2024                                                             2023                                           2024                                         2023


                                                                  Net                Diluted                                Net                         Diluted                 Net                      Diluted                   Net                 Diluted
                                                      Income              EPS(1)                               Income                          EPS(1)              Income                     EPS(1)                  Income                 EPS(1)



              
                GAAP reported                    $191,115                   $3.11                             $94,154                            $1.42             $560,120                         $8.65               $414,832                    $6.10



              Intangible asset amortization                  158,903                    2.58                             151,553                             2.18              627,313                          9.50                608,284                     8.44



              Share-based compensation                        70,190                    1.14                              52,941                             0.76              248,045                          3.76                226,841                     3.15
    expense



              Acquisition accounting                          37,794                    0.61                              32,352                             0.46              135,014                          2.05                151,446                     2.10
    inventory fair value step-up



              Other costs(2)                                       -                                                    61,727                             0.89                                                                  85,215                     1.18



              Non-cash interest expense(3)                     6,081                    0.10                               6,123                             0.09               21,973                          0.33                 22,378                     0.31



              Income tax effect of above                    (58,220)                 (0.94)                           (53,564)                          (0.77)           (222,736)                       (3.37)             (213,172)                  (2.95)
    adjustments



              Effect of assumed conversion                         -                                                                                    (0.01)                                           (0.02)                                        (0.04)
    of the 2024 Notes and the
    2026 Notes(1)



              Non-GAAP adjusted                             $405,863                   $6.60                            $345,286                            $5.02           $1,369,729                        $20.90             $1,295,824                   $18.29



              
                Weighted-average ordinary          61,503                                                     69,673                                               66,007                                              72,066
    shares used in diluted per
    share calculations - GAAP and
    non-GAAP(1)


     ________________________________________________



     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 2.000% exchangeable senior notes due 2026, or the 2026
                                                            Notes. In August 2023 and July 2024, we made irrevocable elections to net share settle the 2024 Notes and the 2026 Notes, respectively. As a result, the assumed issuance of ordinary shares upon
                                                            exchange of the 2024 Notes and the 2026 Notes have only been included in the calculation of diluted net income per ordinary share, on a GAAP and on a non-GAAP adjusted basis, in each period up to the
                                                            date each irrevocable election was made. Net income per diluted share, on a GAAP and on a non-GAAP adjusted basis, for the year ended December 31, 2024, included 3.5 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 and non-GAAP adjusted net income of $10.8 million and $9.7 million,
                                                            respectively. Net income per diluted share, on a GAAP and on a non-GAAP adjusted basis, for the three months and the year ended December 31, 2023 included 6.4 million shares and 8.0 million shares,
                                                            respectively, related to the assumed conversion of the 2024 Notes and the 2026 Notes and the associated interest expense, net of tax, add-back to GAAP reported net income of $4.9 million and $24.9
                                                            million, respectively, and the associated interest expense, net of tax, add-back to non-GAAP adjusted net income of $4.4 million and $22.2 million, respectively.



     2.                                                 
     Includes costs related to the impairment of facility assets and program terminations.



     3.                                                 
     Non-cash interest expense associated with debt issuance costs.


                                                                             
              
                JAZZ PHARMACEUTICALS PLC
                                                                
              RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
                                                              
           CERTAIN LINE ITEMS - FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023
                                                                             
                (In thousands, except percentages)
                                                                                         
                (Unaudited)




                                                                                                                                 
              
                Three months ended December 31, 2024


                                                      Cost of                  Gross                                Selling,                                Research                                Intangible                 Interest               Income tax               Effective
                                             product              margin                               general and                                 and                                     asset                  expense, net               expense                  tax rate
                                              sales                                                   administrative                          development                              amortization                                         (benefit)



              
                GAAP Reported            $128,713                  87.4 %                                $369,287                                 $240,500                                   $158,903                   $51,256                 $(57,912)                (43.5) %



              Non-GAAP Adjustments:



              Intangible asset amortization                -                                                                                                                                        (158,903)



              Share-based compensation               (4,427)                    0.5                                 (46,120)                                (19,643)
    expense



              Acquisition accounting                (37,794)                    3.7
    inventory fair value step-up



              Non-cash interest expense                    -                                                                                                                                                                   (6,081)



              Income tax effect of above                   -                                                                                                                                                                                             58,220                     43.6
    adjustments



              Total of non-GAAP adjustments         (42,221)                    4.2                                 (46,120)                                (19,643)                                 (158,903)                  (6,081)                   58,220                     43.6



              Non-GAAP Adjusted                      $86,492                  91.6 %                                $323,167                                 $220,857                   
              $           -                  $45,175                      $308                    0.1 %


                                                                                                         
            
            Three months ended December 31, 2023


                                                      Cost of        Gross                Selling,              Research                            Intangible          Acquired              Interest                Income tax                Effective
                                             product          margin         general and                 and                               asset                  IPR&D              expense,                 expense                  tax rate
                                              sales                         administrative          development                        amortization                                     net                 (benefit)



              
                GAAP Reported            $107,243        88.9 %                $396,034               $216,608                               $151,553            $18,000                $70,324                  $(33,089)                 (53.8) %



              Non-GAAP Adjustments:



              Intangible asset amortization                                                                                                         (151,553)



              Share-based compensation               (3,653)          0.4                 (33,787)              (15,501)
    expense



              Restructuring and other                                                    (61,727)
    costs



              Non-cash interest expense                                                                                                                                                       (6,123)



              Acquisition accounting                (32,352)          3.3
    inventory fair value step-up



              Income tax effect of above                                                                                                                                                                                 53,564                      59.4
    adjustments



              Total of non-GAAP                     (36,005)          3.7                 (95,514)              (15,501)                             (151,553)                                 (6,123)                    53,564                      59.4
    adjustments



              Non-GAAP Adjusted                      $71,238        92.6 %                $300,520               $201,107               
              $           -           $18,000                $64,201                    $20,475                     5.6 %


                                                                                       
              
                JAZZ PHARMACEUTICALS PLC
                                                                              
          RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
                                                                              
          CERTAIN LINE ITEMS - FOR THE YEAR ENDED DECEMBER 31, 2024 AND 2023
                                                                                        
                (In thousands, except percentages)
                                                                                                   
                (Unaudited)




                                                                                                                                                 
              
         Year ended December 31, 2024


                                                               Cost of        Gross                           Selling,                                 Research                         Intangible          Acquired              Interest                Income tax                Effective
                                                     product           margin                    general and                                  and                              asset                  IPR&D              expense,                expense                   tax rate
                                                      sales                                     administrative                           development                       amortization                                    net                  (benefit)



              
                GAAP Reported                     $445,713        88.3 %                         $1,385,294                                  $884,000                            $627,313            $10,000               $238,097                  $(91,429)                 (19.4) %



              Non-GAAP Adjustments:



              Intangible asset amortization                         -                                                                                                                   (627,313)



              Share-based compensation expense               (14,802)          0.5                           (158,570)                                 (74,673)



              Non-cash interest expense                             -                                                                                                                                                            (21,973)



              Acquisition accounting inventory fair         (135,014)          3.5
    value step-up



              Income tax effect of above                            -                                                                                                                                                                                       222,736                      28.1
    adjustments



              Total of non-GAAP adjustments                 (149,816)          4.0                           (158,570)                                 (74,673)                          (627,313)                                (21,973)                   222,736                      28.1



              Non-GAAP Adjusted                              $295,897        92.3 %                         $1,226,724                                  $809,327            
              $           -           $10,000               $216,124                   $131,307                     8.7 %


                                                                                                                       
            
        Year ended December 31, 2023


                                                                Cost of        Gross                Selling,              Research                        Intangible          Acquired              Interest                Income tax                Effective
                                                      product           margin         general and                 and                           asset                  IPR&D              expense,                expense                   tax rate
                                                       sales                          administrative          development                    amortization                                    net                  (benefit)



              
                GAAP Reported                      $435,577        88.3 %              $1,343,105               $849,658                           $608,284            $19,000               $289,438                 $(119,912)                 (40.2) %



              Non-GAAP Adjustments:



              Intangible asset amortization                                                                                                               (608,284)



              Share-based compensation expense                (15,052)          0.4                (146,942)              (64,847)



              Other costs                                                                          (85,215)



              Non-cash interest expense                                                                                                                                                            (22,378)



              Acquisition accounting inventory fair          (151,446)          4.1
    value step-up



              Income tax effect of above adjustments                                                                                                                                                                          213,172                      46.9



              Total of non-GAAP adjustments                  (166,498)          4.5                (232,157)              (64,847)                         (608,284)                                (22,378)                   213,172                      46.9



              Non-GAAP Adjusted                               $269,079        92.8 %              $1,110,948               $784,811          
              $            -           $19,000               $267,060                    $93,260                     6.7 %


                                                                            
              
                JAZZ PHARMACEUTICALS PLC
                                                   
                RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2025 NET INCOME AND DILUTED EPS GUIDANCE
                                                                          
                (In millions, except per share amounts)
                                                                                        
                (Unaudited)




                                                                                                                                                                  Net Income                    Diluted EPS



            
                GAAP guidance                                                                                                              
       
            $560 - $720  
          
           $9.15 - $11.50



            Intangible asset amortization                                                                                                                   610 -660                    9.70 -10.60



            Acquisition accounting inventory fair value step-up                                                                                             135 -155                     2.15 -2.50



            Share-based compensation expense                                                                                                                240 -270                     3.80 -4.35



            Income tax effect of above adjustments                                                                                                        (215) -(235)                    (3.40) -
                                                                                                                                                                                            (3.75)



            Non-GAAP guidance                                                                                                                         
          $1,400 - $1,500          
         $22.50 - $24.00





            Weighted-average ordinary shares used in per share calculations - GAAP and                                                                                 
         62 - 63
    non-GAAP

Contacts:

Investors:
Jeff Macdonald
Executive Director, 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

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SOURCE Jazz Pharmaceuticals plc