Jazz Pharmaceuticals (JAZZ) reported fourth-quarter 2024 adjusted earnings of $6.60 per share, which beat the Zacks Consensus Estimate of $5.79. Earnings rose 31% year over year.Total revenues rose 8% year over year to $1.09 billion. Sales of Xywav and Epidiolex drove this upside. The reported figure beat the Zacks Consensus Estimate of $1.06 billion.See the Zacks Earnings Calendar to stay ahead of market-making news.Shares of Jazz rose more than 2% in pre-market today, likely due to the better-than-expecte ...

Product Development and Pipeline - The company reported approximately 14,150 patients taking Xywav by the end of 2024, including about 10,250 patients with narcolepsy and approximately 3,900 patients with idiopathic hypersomnia (IH) [417]. - Xywav is recognized as the first and only FDA-approved therapy for the treatment of IH in adults, with seven years of orphan drug exclusivity extending through August 2028 [415]. - The company acquired Epidiolex in May 2021, expanding its neuroscience business with a high-growth childhood-onset epilepsy franchise [418]. - Rylaze was launched in the U.S. in July 2021 and is the only recombinant erwinia asparaginase product approved in the U.S. [419]. - The company focuses on research and development activities within neuroscience and oncology therapeutic areas to drive sustainable growth [408]. - The company aims to identify and develop differentiated therapies for patient populations with high unmet needs [407]. - The company continues to expand its pipeline to achieve a valuable portfolio of durable, highly differentiated products [410]. - Zepzelca was launched in the U.S. in early 2020 for treating SCLC patients after platinum-based chemotherapy, with ongoing promotional efforts targeting SCLC-treating physicians [420]. - A Phase 3 trial in collaboration with Roche for Zepzelca and Tecentriq showed statistically significant benefits, with plans for an sNDA submission in the first half of 2025 [420]. - Zanidatamab received FDA approval in November 2024 for second-line HER2-positive BTC, with a total potential payment to Zymeworks of $1.76 billion under the licensing agreement [427]. - The ongoing Phase 3 trials for zanidatamab include first-line HER2-positive GEA and BTC, with additional trials for previously treated HER2-positive breast cancer [436]. - JZP441, an orexin-2 receptor agonist, achieved initial proof-of-concept in a Phase 1 trial, with plans for a Phase 1b trial in narcolepsy Type 1 patients in 2025 [435]. - The company has multiple ongoing clinical trials for zanidatamab, including a pivotal Phase 2 trial for advanced HER2-amplified BTC, with a BLA submission completed in March 2024 [427]. - The company is exploring options for the suvecaltamide program after recent trials did not achieve statistical significance on primary endpoints [434]. Financial Performance - Product sales, net for 2024 reached $3,821,164, a 2% increase from 2023's $3,736,943, which was a 3% increase from 2022's $3,641,429 [454]. - Royalties and contract revenues surged to $247,786 in 2024, a 155% increase from $97,261 in 2023, which was a 442% increase from $17,945 in 2022 [454]. - Xywav product sales increased by 16% in 2024 to $1,473,202, driven by an 8% increase in patients taking the drug for narcolepsy and a 41% increase for idiopathic hypersomnia (IH) compared to 2023 [458]. - Xyrem product sales decreased by 59% in 2024 to $233,816, primarily due to competition from high-sodium oxybate and the adoption of Xywav [455]. - Research and development expenses rose to $884,000 in 2024, a 4% increase from $849,658 in 2023, with clinical studies and outside services costs contributing significantly [467]. - Selling, general and administrative expenses increased to $1,385,294 in 2024, a 3% increase from $1,343,105 in 2023, driven by higher compensation-related expenses and increased investment in sales and marketing [464]. - The gross margin as a percentage of net product sales was 88.3% in both 2024 and 2023, compared to 85.2% in 2022 [462]. - The company expects product sales to increase in 2025, primarily driven by growth across its commercial portfolio, despite a decrease in Xyrem sales due to competition [460]. - The company anticipates royalties and contract revenues to increase in 2025, primarily due to higher royalty revenues from high-sodium oxybate AG sales [461]. - Research and development expenses are expected to decrease in 2025 compared to 2024, mainly due to reduced costs related to clinical studies [468]. Competition and Market Dynamics - Xywav faces competition from Avadel's Lumryz, which was launched in June 2023, and the company has filed a complaint against the FDA regarding Lumryz's approval [442]. - The launch of authorized generic (AG) versions of high-sodium oxybate has negatively impacted Xyrem and Xywav sales, with Hikma and Amneal launching their AG products in January and July 2023, respectively [443]. - Lupin received tentative approval for a generic version of Xywav on October 13, 2023, indicating increasing generic competition [444]. - The commercial success of Epidiolex/Epidyolex is uncertain due to potential competition from generic products and non-FDA approved alternatives [446]. Shareholder Returns and Capital Management - The company announced a new share repurchase program authorized for up to $500 million, replacing the previous program which had an authorized repurchase amount of $1.5 billion [2]. - The company repurchased 2.8 million ordinary shares for $311.4 million in 2024, with an average purchase price of $110.06 per share [483]. - The New Repurchase Program authorized in July 2024 allows for ongoing share repurchases without an expiration date [483]. Debt and Financing - The principal amount of Tranche B-1 and B-2 Dollar Term Loans each totaled $2.7 billion [491]. - The applicable margin for Tranche B-2 Dollar Term Loans is 2.25% for Term SOFR borrowings, a decrease of 75 basis points from Tranche B-1 [492]. - As of December 31, 2024, the interest rate on Tranche B-2 Dollar Term Loans was 6.61% and the effective interest rate was 8.27% [492]. - The Initial Revolving Credit Facility was increased from $500.0 million to $885.0 million [493]. - Interest on the 2030 Notes is payable at a rate of 3.125% per year, maturing on September 15, 2030 [504]. - The 2026 Notes have an interest rate of 2.00% per year and mature on June 15, 2026 [509]. - The 2024 Notes were repaid in full on August 15, 2024, totaling $575.0 million [513]. - The interest rate on the Secured Notes was 4.375% as of December 31, 2024 [502]. - The Amended Revolving Credit Facility has a commitment fee ranging from 0.25% to 0.45% per annum based on the first lien secured net leverage ratio [495]. Tax and Regulatory Considerations - Income tax benefit was $91.4 million in 2024, down from $119.9 million in 2023 and $158.6 million in 2022, primarily due to changes in income mix across jurisdictions [475]. - Regulatory scrutiny and potential healthcare reforms may impact pricing and reimbursement for the company's products, affecting overall revenue [450]. Cash Flow and Investments - Cash flows from operations were $1.4 billion in 2024, an increase of $303.9 million compared to $1.1 billion in 2023 [484]. - Net cash used in investing activities increased by $345.1 million in 2024 compared to 2023, driven by a $340.0 million net increase in the acquisition of investments [487]. - The company plans to commit substantial resources to product acquisition, development, and expansion of operations [481]. Goodwill and Intangible Assets - As of December 31, 2024, the company had $1.7 billion of goodwill resulting from acquisitions accounted for as business combinations [531]. - The fair value of the reporting unit significantly exceeded its carrying amount, indicating no impairment of goodwill as of the annual test in October 2024 [531]. - The company expects to continue acquiring intangible assets, with fair values determined using discounted cash flow models [533]. - As of December 31, 2024, the company had $4.8 billion of finite-lived intangible assets, including $3.3 billion related to Epidiolex and $1.0 billion related to Vyxeos [537]. - No impairment charge was recognized for intangible assets in 2024 or 2023; however, a $133.6 million impairment charge was recorded in 2022 for the nabiximols program [538]. Foreign Exchange and Interest Rate Management - A hypothetical 10% strengthening or weakening in exchange rates would have increased or decreased net income by approximately $78.0 million for sterling and $3.3 million for euro [553]. - As of December 31, 2024, the net liability fair value of outstanding foreign exchange forward contracts was $7.9 million, with notional amounts totaling $461.2 million [554]. - The company entered into interest rate swap agreements with a notional amount of $500.0 million, fixing the interest rate on a portion of term loan borrowings at 3.9086% until April 30, 2026 [550]. - The fair values of the 2030 Notes, Secured Notes, and 2026 Notes were estimated to be $1.1 billion, $1.4 billion, and $1.0 billion, respectively, as of December 31, 2024 [552]. Tax Jurisdictions - The company has significant operations in Ireland, the U.K., and the U.S., which are its most significant tax jurisdictions [541].

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) Q4 2024 Earnings Conference Call February 25, 2025 4:30 PM ET Company Participants Jeff Macdonald - Executive Director, Investor Relations Bruce Cozadd - Co-Founder, Chairman and Chief Executive Officer Renée Galá - President and Chief Operating Officer Robert Iannone - Executive Vice President, Global Head, Research and Development, Chief Medical Officer Philip Johnson - Executive Vice President and Chief Financial Officer Conference Call Participants Marc Goodman - L ...

Core Insights - Jazz Pharmaceuticals reported revenue of $1.09 billion for the quarter ended December 2024, reflecting a year-over-year increase of 7.5% and an EPS of $6.60, up from $5.02 in the same quarter last year, surpassing both revenue and EPS consensus estimates [1] Revenue Performance - Product sales netted $1.03 billion, exceeding the average analyst estimate of $995.17 million, with a year-over-year change of +6% [4] - Oncology product Defitelio/defibrotide generated $57.65 million, surpassing the nine-analyst average estimate of $46.52 million, marking a +12.9% year-over-year change [4] - Neuroscience product Oxybate (Xywav) achieved $400.96 million, exceeding the average estimate of $393.28 million, with a +19% year-over-year change [4] - Neuroscience product Epidiolex/Epidyolex reported $275.05 million, compared to the average estimate of $264.59 million, reflecting a +14.3% year-over-year change [4] - Neuroscience product Sativex generated $5.17 million, slightly below the average estimate of $6.58 million, with a +0.7% year-over-year change [4] - Total revenues from Neuroscience reached $730.47 million, exceeding the average estimate of $714.23 million, with a +5.9% year-over-year change [4] - Total revenues from Oncology amounted to $291.76 million, surpassing the average estimate of $276.22 million, with a +6.6% year-over-year change [4] - Rylaze generated $101.49 million, slightly below the average estimate of $99.81 million, with a -0.3% year-over-year change [4] - Vyxeos achieved $53.25 million, exceeding the average estimate of $42.05 million, with a +13.5% year-over-year change [4] - Zepzelca reported $78.33 million, below the average estimate of $91.31 million, with a +5.8% year-over-year change [4] - Other revenues totaled $2.97 million, below the average estimate of $3.84 million, reflecting a -27.3% year-over-year change [4] Stock Performance - Jazz Pharmaceuticals' shares returned +9.9% over the past month, contrasting with the Zacks S&P 500 composite's -1.8% change, indicating strong relative performance [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

February 25, 2025 2024 Fourth Quarter and Full Year Financial Results Innovating to Transform the Lives of Patients and Their Families EPIDIOLEX® patient diagnosed with Dravet syndrome February 25, 2025 Markella Transforming Lives. Redefining Possibilities. Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements and financial targets, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, in ...

Group 1 - Jazz Pharmaceuticals reported quarterly earnings of $6.60 per share, exceeding the Zacks Consensus Estimate of $5.79 per share, and up from $5.02 per share a year ago, representing an earnings surprise of 13.99% [1] - The company achieved revenues of $1.09 billion for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 2.57%, and an increase from $1.01 billion year-over-year [2] - Over the last four quarters, Jazz has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] Group 2 - The stock has gained approximately 11% since the beginning of the year, outperforming the S&P 500's gain of 1.7% [3] - The current consensus EPS estimate for the upcoming quarter is $4.34 on revenues of $981.29 million, and for the current fiscal year, it is $22.11 on revenues of $4.33 billion [7] - The Medical - Biomedical and Genetics industry, to which Jazz belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook [8]

Revenue Expectations and Growth - The company expects total revenue for 2024 to be in the range of $4.0 billion to $4.1 billion, with a significant portion driven by Xyrem and its acquired products[12]. - The company has achieved 20 consecutive years of year-over-year revenue growth, with a compound annual growth rate (CAGR) of 13.5% from 2018 to 2024[16]. - The company reported over $1.1 billion in revenue from Zepzelca since its launch in mid-2020, indicating strong market acceptance[14]. - The company anticipates that Epidiolex will reach blockbuster status in 2025, with peak sales potential exceeding $2 billion[14]. - The company expects to meet its 2024 guidance for total, neuroscience, and oncology revenues, reflecting confidence in its diversified portfolio[15]. Pipeline and Product Development - The company is positioned to submit a supplemental New Drug Application (sNDA) for 1L ES-SCLC in the first half of 2025, following positive Phase 3 trial results[28]. - The company has a robust pipeline with key programs in various phases, including Zanidatamab and Zepzelca, aimed at addressing significant unmet medical needs[21]. - The company has initiated a Phase 3 confirmatory trial for Zanidatamab in 1L GEA, with top-line results expected in 2025[24]. - Ziihera (zanidatamab-hrii) approved in the U.S. for previously treated, unresectable or metastatic HER2+ biliary tract cancer (BTC) with potential EMA approval as early as 2Q25[40]. - The Phase 3 EmpowHER trial initiated in 2H24 aims to explore zanidatamab's efficacy in various HER2+ cancers, expanding its therapeutic potential[40]. Financial Strength and Capital Allocation - The company has approximately $2.6 billion in cash and cash equivalents, providing financial strength for strategic transactions and partnerships[14]. - Jazz Pharmaceuticals maintains a disciplined capital allocation strategy with ~$1.0 billion in cash from operations and $2.6 billion in cash, cash equivalents, and investments as of September 30, 2024[54]. Product Performance and Market Needs - Xywav annualizing over $1.5 billion in net product sales as of 3Q24, remains the 1 branded treatment for narcolepsy[50]. - Rylaze generated approximately $1.1 billion in revenue since its launch in mid-2021, addressing a critical need for patients with hypersensitivity reactions to E. coli-derived asparaginase[46]. - Epidiolex poised to reach blockbuster status in 2025, with ongoing education on treatment synergies and growth opportunities in the adult patient setting[48]. - Significant unmet need in extensive-stage small cell lung cancer (SCLC), with ~30,000 1L SCLC patients in the U.S. and a plan to submit sNDA for 1L ES-SCLC in 1H25[44]. Strategic Focus and Growth Initiatives - The company has a diverse product mix, with significant revenue contributions from its oncology, neuroscience, and sleep medicine segments[31]. - Ziihera's launch supported by a proven oncology team and established infrastructure, focusing on key customer engagement and patient support services[38]. - The company is advancing its differentiated pipeline to support future growth, including ongoing trials for multiple HER2-expressing indications[40]. - Jazz Pharmaceuticals is focused on diversifying transactions to drive long-term growth and shareholder value[57].

Core Insights - Jazz Pharmaceuticals reported record total revenues of over $4 billion for the year 2024, reflecting a 6% year-over-year growth [2][6][14] - The company anticipates continued growth in 2025, with guidance for total revenues between $4.15 billion and $4.40 billion, representing a 5% growth at the midpoint [7][22] Financial Performance - Total revenues for Q4 2024 were $1.1 billion, up from $1.0 billion in Q4 2023 [10][12] - 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 [10][11] - Non-GAAP adjusted net income for 2024 was $1.37 billion, or $20.90 per diluted share, compared to $1.30 billion, or $18.29 per diluted share, for 2023 [11][12] Revenue Breakdown - Xywav net product sales increased 16% to $1.47 billion in 2024, while Epidiolex/Epidyolex sales rose 15% to $972.4 million [6][12] - Oncology revenues surpassed $1.1 billion in 2024, growing 9% year-over-year [6][16] - Zepzelca net product sales increased 11% to $320.3 million in 2024 [13][16] Pipeline Developments - Ziihera was approved for 2L HER2+ biliary tract cancer and achieved first sales in December 2024 [6][13] - Upcoming top-line data from the HERIZON-GEA-01 trial in 1L gastroesophageal adenocarcinoma is expected in the second half of 2025 [2][7] - The company plans to submit a supplemental New Drug Application for Zepzelca in combination with Tecentriq for 1L extensive-stage small cell lung cancer in the first half of 2025 [7][13] Operating Expenses - Total operating expenses for 2024 were $3.35 billion, compared to $3.26 billion in 2023 [10][12] - Selling, general and administrative expenses increased due to higher compensation-related expenses and increased investment in sales and marketing [20][21] Cash Flow and Balance Sheet - The company generated over $1.4 billion in cash from operations in 2024 [7][19] - As of December 31, 2024, cash, cash equivalents, and investments totaled $3.0 billion, with long-term debt at $6.2 billion [19][37]

Core Viewpoint - Analysts expect Jazz Pharmaceuticals to report quarterly earnings of $5.79 per share, reflecting a year-over-year increase of 15.3%, with revenues projected at $1.06 billion, up 4.8% from the previous year [1] Revenue Estimates - Analysts estimate 'Revenues- Product sales, net' at $995.17 million, indicating a change of +2.9% year-over-year [4] - 'Total revenues- Neuroscience- Oxybate- Xywav' is projected to reach $393.28 million, suggesting a change of +16.7% year-over-year [4] - 'Total revenues- Neuroscience- Epidiolex/Epidyolex' is expected to be $264.59 million, reflecting a change of +10% from the prior year [5] - 'Total revenues- Neuroscience- Sativex' is estimated at $6.58 million, indicating a change of +28.2% year-over-year [5] - 'Total revenues- Neuroscience- Oxybate (Xywav & Xyrem)' is forecasted at $443.06 million, showing a change of -0.2% from the previous year [6] - 'Total revenues- Neuroscience- Total' is expected to reach $714.23 million, indicating a change of +3.6% year-over-year [6] - 'Total revenues- Oncology- Total' is projected at $276.22 million, reflecting a change of +0.9% from the prior year [6] - 'Total revenues- Oncology- Rylaze' is estimated at $99.81 million, indicating a change of -1.9% year-over-year [7] - 'Total revenues- Oncology- Defitelio/defibrotide' is expected to be $46.52 million, reflecting a change of -8.9% from the previous year [7] - 'Total revenues- Oncology- Vyxeos' is projected at $42.05 million, indicating a change of -10.4% year-over-year [8] - 'Total revenues- Oncology- Zepzelca' is expected to reach $91.31 million, reflecting a change of +23.4% from the prior year [8] - 'Total revenues- Other' is estimated at $3.84 million, indicating a change of -6.1% from the previous year [8] Stock Performance - Jazz shares have increased by +11.7% over the past month, outperforming the Zacks S&P 500 composite, which rose by +2.6% [9]

Group 1: Jazz Pharmaceuticals - Jazz Pharmaceuticals (JAZZ) shares increased by 5.2% to close at $129.98, driven by notable trading volume and optimism regarding its diverse portfolio of marketed drugs, including therapies for sleep disorders, epilepsy, and cancer treatments [1] - The company is expected to report quarterly earnings of $5.79 per share, reflecting a year-over-year increase of 15.3%, with revenues projected at $1.06 billion, up 4.8% from the previous year [2] - The consensus EPS estimate for Jazz has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [3] Group 2: Dianthus Therapeutics - Dianthus Therapeutics, Inc. has a consensus EPS estimate of -$0.85 for the upcoming report, representing a 19.7% decline from the previous year [4] - Dianthus currently holds a Zacks Rank of 4 (Sell), indicating weaker performance expectations compared to Jazz Pharmaceuticals [4]