[Third Quarter 2024 Financial Results and Highlights](index=1&type=section&id=Third%20Quarter%202024%20Financial%20Results%20and%20Highlights) [Key Highlights](index=1&type=section&id=Key%20Highlights) Jazz Pharmaceuticals achieved record Q3 2024 revenues exceeding $1.05 billion, driven by key growth products and affirmed full-year guidance with raised EPS forecasts and significant pipeline advancements - Key growth drivers (Xywav, Epidiolex, Rylaze) collectively grew **14% year-over-year**[1](index=1&type=chunk)[3](index=3&type=chunk) Updated 2024 Financial Guidance Highlights | Guidance Metric | 2024 Outlook | | :--- | :--- | | Total Revenue | $4.0 to $4.1 billion (Affirmed) | | Oncology Revenue | $1.08 to $1.13 billion (Lowered) | | Non-GAAP R&D Expense | $790 to $830 million (Lowered) | | GAAP EPS | $6.70 to $8.50 (Raised) | | Non-GAAP EPS | $19.50 to $20.60 (Raised) | - Key pipeline milestones include the zanidatamab PDUFA target action date of **November 29, 2024**, for 2L BTC and a planned sNDA submission for Zepzelca in 1L ES-SCLC in the **first half of 2025**[1](index=1&type=chunk)[2](index=2&type=chunk)[3](index=3&type=chunk) [Business and Pipeline Updates](index=2&type=section&id=Business%20and%20Pipeline%20Updates) [Commercial Updates](index=2&type=section&id=Commercial%20Updates) The commercial portfolio showed robust Q3 2024 performance, with Xywav and Epidiolex leading growth, while Xyrem declines were offset by authorized generic royalties [Xywav](index=2&type=section&id=Xywav) Xywav net product sales increased **17%** to **$388.5 million** in Q3 2024, adding approximately **400** new patients for a total of **13,625** active patients Xywav Q3 2024 Performance | Metric | Value | | :--- | :--- | | Net Product Sales | $388.5 million | | YoY Growth | +17% | | Net Patient Additions | ~400 | | Total Active Patients | ~13,625 | [Xyrem and AG Royalties](index=2&type=section&id=Xyrem%20and%20AG%20Royalties) Xyrem net product sales declined **54%** to **$58.1 million** in Q3 2024, offset by **$58.2 million** in high-sodium oxybate authorized generic royalties Xyrem & AG Royalties Q3 2024 (vs Q3 2023) | Product/Revenue Stream | Q3 2024 Sales | YoY Change | | :--- | :--- | :--- | | Xyrem Net Sales | $58.1 million | -54% | | High-Sodium Oxybate AG Royalties | $58.2 million | +$29.2 million | [Epidiolex/Epidyolex](index=2&type=section&id=Epidiolex%2FEpidyolex) Epidiolex/Epidyolex net product sales grew **18%** year-over-year to **$251.6 million** in Q3 2024, with approvals in over **35** countries - Epidiolex/Epidyolex net product sales reached **$251.6 million** in Q3 2024, an **18% increase** compared to Q3 2023[5](index=5&type=chunk) [Rylaze/Enrylaze](index=2&type=section&id=Rylaze%2FEnrylaze) Rylaze/Enrylaze net sales decreased **6%** to **$98.8 million** in Q3 2024 due to temporary protocol updates, with normalization expected by early 2025 - Rylaze revenue was temporarily impacted by an update to pediatric ALL protocols, with demand expected to normalize by **early 2025**[6](index=6&type=chunk) [Zepzelca](index=2&type=section&id=Zepzelca) Zepzelca net sales grew **10%** to **$85.8 million** in Q3 2024, with positive Phase 3 results supporting a planned sNDA submission in 1L ES-SCLC by mid-2025 - Based on positive Phase 3 results in 1L ES-SCLC, the company plans to submit an sNDA for Zepzelca in the **first half of 2025**[6](index=6&type=chunk) [Key Pipeline Highlights](index=3&type=section&id=Key%20Pipeline%20Highlights) The pipeline is advancing, with zanidatamab granted FDA Priority Review for 2L BTC, targeting a PDUFA date of **November 29, 2024**, and further data readouts planned for 2025 [Zanidatamab](index=3&type=section&id=Zanidatamab) Zanidatamab is under FDA Priority Review for BTC with a **November 29, 2024**, PDUFA date, and anticipates Q4 2024 launch, with further trial data expected in 2025 - The FDA granted Priority Review for zanidatamab in 2L BTC, with a PDUFA target action date of **November 29, 2024**[7](index=7&type=chunk) - Top-line data from the pivotal HERIZON-GEA-01 trial for zanidatamab in 1L GEA is expected in **Q2 2025**[7](index=7&type=chunk) - A new Phase 2 pan-tumor trial (DiscovHER-Pan-206) has been initiated to evaluate zanidatamab in HER2-positive solid tumors[7](index=7&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) [Financial Highlights (Q3 2024)](index=3&type=section&id=Financial%20Highlights%20%28Q3%202024%29) Jazz Pharmaceuticals achieved total revenues of **$1.055 billion** in Q3 2024, a **9%** increase, with GAAP net income reaching **$215.1 million** and non-GAAP adjusted net income **$416.9 million** Q3 2024 vs. Q3 2023 Financial Highlights (in thousands, except per share) | Metric | Q3 2024 | Q3 2023 | | :--- | :--- | :--- | | Total Revenues | $1,054,969 | $972,140 | | GAAP Net Income | $215,055 | $146,820 | | Non-GAAP Adjusted Net Income | $416,924 | $340,148 | | GAAP EPS (diluted) | $3.42 | $2.14 | | Non-GAAP Adjusted EPS (diluted) | $6.61 | $4.84 | [Total Revenues](index=3&type=section&id=Total%20Revenues) Total revenues increased **9%** to **$1.055 billion** in Q3 2024, driven by **8%** growth in Neuroscience revenue and **9%** growth in Oncology net product sales Q3 2024 Revenue Breakdown (in thousands) | Segment / Product | Q3 2024 Revenue | Q3 2023 Revenue | | :--- | :--- | :--- | | **Total Neuroscience** | **$702,724** | **$675,081** | | Xywav | $388,466 | $331,633 | | Epidiolex/Epidyolex | $251,558 | $213,711 | | Xyrem | $58,114 | $125,110 | | **Total Oncology** | **$284,754** | **$260,410** | | Rylaze/Enrylaze | $98,780 | $104,859 | | Zepzelca | $85,843 | $77,994 | | Defitelio/defibrotide | $65,818 | $47,730 | | **High-sodium oxybate AG royalty** | **$58,157** | **$28,921** | | **Total Revenues** | **$1,054,969** | **$972,140** | [Operating Expenses and Effective Tax Rate](index=5&type=section&id=Operating%20Expenses%20and%20Effective%20Tax%20Rate) Q3 2024 GAAP R&D expenses decreased to **$199.9 million**, while GAAP SG&A expenses increased to **$325.8 million**, resulting in a GAAP effective tax rate of **(7.2%)** Q3 2024 vs. Q3 2023 Operating Expenses (GAAP, in thousands) | Expense Line | Q3 2024 | Q3 2023 | | :--- | :--- | :--- | | Cost of product sales | $111,611 | $102,153 | | Selling, general and administrative | $325,772 | $308,310 | | Research and development | $199,919 | $234,402 | - The decrease in R&D expenses was primarily due to lower clinical program costs for JZP150 and zanidatamab[18](index=18&type=chunk) - The increase in SG&A expenses was primarily due to increased compensation-related expenses driven by higher headcount to support key growth drivers[17](index=17&type=chunk) [Cash Flow and Balance Sheet](index=6&type=section&id=Cash%20Flow%20and%20Balance%20Sheet) As of September 30, 2024, Jazz held **$2.6 billion** in cash and investments, with **$6.2 billion** in long-term debt, generating **$997.3 million** in cash from operations year-to-date Key Financial Position Data (as of Sep 30, 2024) | Metric | Value | | :--- | :--- | | Cash, cash equivalents and investments | $2.6 billion | | Long-term debt (principal balance) | $6.2 billion | | Cash from operations (YTD) | $997.3 million | [Senior Notes Offering and Share Repurchases](index=3&type=section&id=Senior%20Notes%20Offering%20and%20Share%20Repurchases) In Q3 2024, the company completed a **$1.0 billion** private placement of exchangeable senior notes and repurchased approximately **$150.0 million** of its ordinary shares - Completed a private placement of **$1.0 billion** aggregate principal amount of **3.125%** exchangeable senior notes due **2030**[8](index=8&type=chunk) - Concurrently repurchased approximately **$150.0 million** of its ordinary shares as part of its share repurchase program[8](index=8&type=chunk) [2024 Financial Guidance](index=7&type=section&id=2024%20Financial%20Guidance) [Updated Full-Year 2024 Guidance](index=7&type=section&id=Updated%20Full-Year%202024%20Guidance) Jazz Pharmaceuticals affirmed full-year 2024 total revenue guidance at **$4.0 to $4.1 billion**, while raising GAAP and non-GAAP EPS guidance due to strategic pipeline prioritization Full-Year 2024 Guidance Update (in millions, except per share amounts) | Metric | Updated Guidance (Nov 6, 2024) | Previous Guidance (Jul 31, 2024) | | :--- | :--- | :--- | | Total Revenues | $4,000 - $4,100 | $4,000 - $4,100 | | Oncology Revenue | $1,080 - $1,130 | $1,100 - $1,180 | | GAAP R&D Expenses | $862 - $908 | $887 - $935 | | Non-GAAP R&D Expenses | $790 - $830 | $810 - $850 | | GAAP Net Income per Diluted Share | $6.70 - $8.50 | $6.00 - $8.00 | | Non-GAAP Net Income per Diluted Share | $19.50 - $20.60 | $19.20 - $20.30 | [Supplementary Information](index=8&type=section&id=Supplementary%20Information) [Conference Call Details](index=8&type=section&id=Conference%20Call%20Details) This section provides logistical details for the investor conference call and webcast held on **November 6, 2024**, to discuss Q3 2024 financial results - An investor conference call and webcast were scheduled for **4:30 p.m. ET** on **November 6, 2024**, to discuss Q3 results[26](index=26&type=chunk) [Non-GAAP Financial Measures Explanation](index=9&type=section&id=Non-GAAP%20Financial%20Measures%20Explanation) The company utilizes non-GAAP financial measures to supplement GAAP results, providing investors and management with enhanced insights into operating trends and performance - The company uses non-GAAP financial measures to supplement GAAP results, facilitating better analysis of operating trends and period-to-period comparisons for investors and management[30](index=30&type=chunk)[31](index=31&type=chunk) [Forward-Looking Statements](index=10&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding growth, financial guidance, and pipeline, subject to significant risks and uncertainties that may cause actual results to differ materially - The report contains forward-looking statements concerning financial guidance, pipeline development (e.g., Zepzelca sNDA, zanidatamab launch), and commercial expectations, which are subject to significant risks and uncertainties[34](index=34&type=chunk)[35](index=35&type=chunk)[37](index=37&type=chunk) [Detailed Financial Statements and Reconciliations](index=12&type=section&id=Detailed%20Financial%20Statements%20and%20Reconciliations) This section provides detailed unaudited consolidated financial statements for Q3 2024 and 2023, including Statements of Operations, Balance Sheets, and Cash Flows, along with GAAP to non-GAAP reconciliations - The report includes detailed unaudited Consolidated Statements of Operations, Balance Sheets, and Statements of Cash Flows[39](index=39&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk) - Provides comprehensive reconciliations of GAAP reported financial information to non-GAAP adjusted information for historical periods and for 2024 financial guidance[44](index=44&type=chunk)[46](index=46&type=chunk)[52](index=52&type=chunk)

– 14% year-over-year revenue increase from combined key growth drivers:Xywav®, Epidiolex® and Rylaze® –– 2024 total revenue guidance affirmed at $4.0 to $4.1 billion –– Zanidatamab 2L BTC PDUFA date of November 29, 2024 –– Plan to submit sNDA for Zepzelca® in 1L ES-SCLC in 1H25 –DUBLIN, Nov. 6, 2024  /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the third quarter of 2024 and updated guidance for 2024."Jazz once again delivered record revenues of more than $1.0 ...

Core Insights - The Ritz-Carlton, Naples is hosting its inaugural "NYE Black-Tie Gala" on New Year's Eve, featuring a luxurious five-course dinner and live jazz performances by Stella Cole, marking a significant addition to the resort's event offerings [2][3]. Event Details - The gala includes a 'Meet the Artist' reception, a five-course dinner curated by Executive Chef Satish Yerramilli, and a live performance by Stella Cole, culminating in a midnight countdown [4][5]. - Guests can enjoy premium bar selections and receive an autographed album of Stella Cole's debut release [5]. Ticket Pricing - Ticket options include Premiere Seating at $650 per person, Reserved Seating at $525 per person, and Large Table Reservations starting from $500 per person, all packages inclusive of taxes, gratuity, and valet parking [7]. Room Reservations - An exclusive "NYE Black-Tie Gala" package is available, which includes an overnight stay in a Coastal View Guestroom and two reserved seating-level tickets for the gala [8]. About The Ritz-Carlton, Naples - The Ritz-Carlton, Naples is a luxury resort featuring 474 guest rooms, a newly renovated Vanderbilt Tower, and various dining venues, recognized for its high standards and numerous accolades [10].

DUBLIN, Oct. 23, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that it will report its 2024 third quarter financial results on Wednesday, November 6, 2024, after the close of the U.S. financial markets. Company management will host a live audio webcast at 4:30 p.m. ET / 9:30 p.m. GMT to discuss 2024 third quarter financial results and provide a business and financial update.  Audio webcast/conference call: U.S. Dial-In Number: +1 800 715 9871Ireland Dial-In Number: +353 1800 9 ...

The proven Zacks Rank system focuses on earnings estimates and estimate revisions to find winning stocks. Nevertheless, we know that our readers all have their own perspectives, so we are always looking at the latest trends in value, growth, and momentum to find strong picks. Of these, value investing is easily one of the most popular ways to find great stocks in any market environment. Value investors use tried-and-true metrics and fundamental analysis to find companies that they believe are undervalued at ...

Investors interested in Medical - Drugs stocks are likely familiar with Jazz Pharmaceuticals (JAZZ) and Zoetis (ZTS) . But which of these two stocks presents investors with the better value opportunity right now? Let's take a closer look. The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Style Scores highlight companies with speci ...

Core Viewpoint - Jazz Pharmaceuticals' shares increased nearly 6% following positive results from the phase III IMforte study, which evaluated the combination of Zepzelca and Roche's Tecentriq in treating extensive-stage small cell lung cancer [1][2]. Group 1: Study Results - The IMforte study demonstrated statistically significant improvements in overall survival and progression-free survival for the Zepzelca-Tecentriq combination compared to Tecentriq alone [2]. - The combination therapy was well-tolerated among participants, with no new safety signals reported [2]. Group 2: Regulatory Plans - Jazz Pharmaceuticals plans to submit a regulatory filing in the first half of 2025 for the Zepzelca-Tecentriq combination as a first-line maintenance treatment for extensive-stage small cell lung cancer [3]. - PharmaMar, which licensed Zepzelca to Jazz, also intends to submit a regulatory filing with the EMA for the same combination in the first half of 2025 [4]. Group 3: Current Market Performance - Year-to-date, Jazz Pharmaceuticals' shares have decreased by 4.6%, while the industry has seen a decline of 2.9% [3]. - Jazz's Zepzelca has been under accelerated FDA approval since 2020 for treating adult patients with metastatic small-cell lung cancer previously treated with platinum-based chemotherapy [3]. Group 4: Future Studies - The company is currently conducting the confirmatory phase III LAGOON study to evaluate Zepzelca for patients with relapsed small cell lung cancer, with plans to convert accelerated approval to full approval if results are positive [3].

Group 1 - Investors have not fully recognized the significance of two recent legal victories for Jazz Pharmaceuticals, which are expected to enhance the company's long-term prospects [2] - The first legal win was a partial victory against a competitor, indicating a positive shift in the competitive landscape for Jazz Pharmaceuticals [2] Group 2 - The article emphasizes the importance of tracking attractive risk/reward situations in the biotech sector, suggesting that there are potential growth stocks worth considering [2]

Jazz Pharmaceuticals (JAZZ, Financial), a leading player in the narcolepsy market, is expanding its reach into other markets such as the non-small cell lung cancer (NSCLC) market by preparing a new biliary tract cancer drug; Zanidatamab. Zanidatamab that belongs to the NSCLC market is estimated to be worth $32 billion. Capturing even a modest 5% share could translate into $1.6 billion in additional revenue for Jazz. Considering the company's 2023 revenue of $3.8 billion, this represents a substantial growth ...

Jazz Pharmaceuticals (JAZZ) focuses on making drugs for neuroscience and oncology. The company derives most of its revenues from its sleep disorder drugs — Xywav and Xyrem. Xywav is a low-sodium formulation of Jazz's legacy drug, Xyrem. It also has a rapidly growing oncology portfolio. Jazz's revenues continue to benefit from strong demand for newer drugs like Xywav, Epidiolex and Rylaze. Jazz has also regularly boosted its commercial portfolio and pipeline through acquisitions. Jazz boasts a promising pipe ...