Group 1 - Jazz Pharmaceuticals will participate in the Wells Fargo Healthcare Conference on September 4, 2024, and the Bank of America Global Healthcare Conference on September 18, 2024 [1] - The company will host fireside chats at both conferences, with specific times provided for each event [1] - Audio webcasts of the fireside chats will be available on the Jazz Pharmaceuticals investor website, with replays archived for 30 days [1] Group 2 - Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for serious diseases with limited therapeutic options [2] - The company has a diverse portfolio that includes leading therapies for sleep disorders, epilepsy, and a growing range of cancer treatments [2] - Jazz Pharmaceuticals is headquartered in Dublin, Ireland, and has research and development facilities, manufacturing sites, and employees in multiple countries [2]

Investors with an interest in Medical - Drugs stocks have likely encountered both Jazz Pharmaceuticals (JAZZ) and Catalent (CTLT) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look. We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Style ...

Shares of Jazz Pharmaceuticals (JAZZ) have gained 10.8% over the past four weeks to close the last trading session at $111.60, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $174.83 indicates a potential upside of 56.7%. The average comprises 18 short-term price targets ranging from a low of $113 to a high of $230, with a standard deviation of $33.43. While the lowest estimate ...

Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks. Looking at the history of these trends, perhaps none is more beloved than value investing. This strategy simply looks to identify companies that are being undervalued by the broader market. Value investors use fundamental analysis and traditional v ...

Jazz Pharmaceuticals (JAZZ) reported adjusted earnings of $5.30 per share in second-quarter 2024, beating the Zacks Consensus Estimate of $4.68. Earnings rose 18% year over year. Total revenues in the reported quarter rose 7% year over year to $1.02 billion. Sales of Xywav, Epidiolex and Rylaze drove the upside. The reported figure beat the Zacks Consensus Estimate of $1.0 billion. Quarter in Detail Net product sales rose 2% year over year at $964.1 million. The reported figure beat the Zacks Consensus Esti ...

Company Strategy and Focus - Jazz Pharmaceuticals reported a focus on developing life-changing medicines for serious diseases, particularly in neuroscience and oncology[82]. - The company announced that it will no longer provide Vision 2025 metrics, shifting focus to long-term value creation and will provide 2025 financial guidance in Q4 2024 earnings call[82]. - The company aims to expand its pipeline by identifying and acquiring novel product candidates to complement its existing portfolio[82]. - Jazz Pharmaceuticals is committed to addressing unmet medical needs through strong commercial execution and diversified revenue growth[82]. - The company is focused on research and development activities within neuroscience and oncology therapeutic areas in 2024[82]. - The company emphasizes the importance of indication expansion and entry into global markets to unlock further value[82]. - Jazz Pharmaceuticals is leveraging its efficient operating model to effectively reach patients worldwide[82]. Product Development and Clinical Trials - Xywav, an oxybate therapy, has become a standard of care for narcolepsy and idiopathic hypersomnia, with FDA approval received in 2020 and 2021 respectively[86]. - Xywav has seven years of Orphan Drug Exclusivity until July 2027, emphasizing its clinical superiority over Xyrem due to reduced sodium content[86]. - The oncology portfolio includes products like Rylaze and Zepzelca, which are approved for treating acute lymphoblastic leukemia and metastatic small cell lung cancer respectively[84]. - Zanidatamab is under evaluation in multiple clinical trials for HER2-expressing cancers, with a BLA submission for second-line biliary tract cancer completed in March 2024[90]. - Zepzelca is being evaluated in a pivotal Phase 3 trial in combination with Tecentriq for first-line extensive stage small cell lung cancer (SCLC)[90]. - The company is conducting a Phase 3 trial of Epidyolex for LGS, DS, and TSC in Japan, initiated in October 2022[91]. - The Phase 2 trial for suvecaltamide in essential tremor did not achieve statistical significance, and further evaluation is ongoing[91]. - The company plans to initiate a small Phase 1b trial of JZP441 in narcolepsy Type 1 patients following safety findings review[91]. Financial Performance and Sales - Product sales for the three months ended June 30, 2024, were $964,144, a 2% increase from $946,987 in the same period of 2023[98]. - Xywav product sales increased by 13% to $368,472 for the three months ended June 30, 2024, compared to $326,564 in 2023, driven by a 14% increase in sales volumes[100][101]. - Xyrem product sales decreased by 61% to $62,180 for the three months ended June 30, 2024, compared to $159,769 in 2023, primarily due to competition from high-sodium oxybate[100][101]. - Total revenues for the three months ended June 30, 2024, were $1,023,825, a 7% increase from $957,317 in the same period of 2023[100]. - The company expects total product sales to increase in 2024, driven by growth in Xywav, Epidiolex, and Rylaze, despite a decrease in Xyrem sales[101]. Research and Development Expenses - Research and development expenses increased by 5% to $220,734 for the three months ended June 30, 2024, compared to $209,238 in 2023[98][105]. - Clinical studies and outside services costs rose due to higher costs related to zanidatamab programs[106]. - Research and development expenses increased by $11.5 million and $44.9 million for the three and six months ended June 30, 2024, compared to the same periods in 2023[106]. - Personnel expenses increased by $2.2 million and $14.8 million for the three and six months ended June 30, 2024, primarily driven by increased compensation costs and higher headcount[106]. Competition and Market Challenges - Xywav and Xyrem face competition from Avadel's Lumryz, which was launched in June 2023, leading to a legal complaint regarding FDA's approval of Lumryz[95]. - In January 2023, an authorized generic version of high-sodium oxybate was launched, negatively impacting Xyrem and Xywav sales[95]. - Lupin received tentative approval for a generic version of Xywav on October 13, 2023, indicating increased competition in the market[96]. - The commercial success of Epidiolex/Epidyolex is uncertain due to potential competition from generic products and non-FDA approved alternatives[96]. - The company faces significant competition from larger companies and generic drugs, which may adversely affect sales[125]. Financial Condition and Debt - The company recorded a $133.6 million asset impairment charge in Q3 2022 due to the discontinuation of the nabiximols program[96]. - The Inflation Reduction Act of 2022 may negatively affect the company's pricing and revenue from its products starting in 2026[96]. - The company is subject to increasing pricing pressure and restrictions on reimbursement from payors, which could adversely affect its financial condition[96]. - The company has incurred substantial debt, which could impair financial flexibility and access to capital[127]. - As of June 30, 2024, the company had cash, cash equivalents, and investments totaling $2.0 billion[113]. - Jazz Lux borrowed an additional $201.9 million in Tranche B-1 Dollar Term Loans and $289.6 million in Tranche B-2 Dollar Term Loans, totaling $2.7 billion outstanding for each tranche[122]. - The interest rate for Tranche B-2 Dollar Term Loans is set at 7.59%, a decrease of 75 basis points from the previous tranche[122]. - The principal amount of Tranche B-1 and B-2 Dollar Term Loans is subject to quarterly amortization of 0.2863% with the remaining balance due on May 5, 2028[122]. Cash Flow and Investments - Cash flows from operations generated were $598.6 million during the six months ended June 30, 2024[113]. - Net cash used in investing activities increased by $438.4 million in the six months ended June 30, 2024, primarily due to a $425.0 million net increase in the acquisition of investments[118]. - The company spent $161.4 million to repurchase 1.5 million ordinary shares at an average price of $110.75 per share during the three and six months ended June 30, 2024[116]. Regulatory and Compliance - The company’s disclosure controls and procedures were deemed effective as of June 30, 2024[129]. - There were no material changes to market risk disclosures during the six months ended June 30, 2024[128]. - The company has not experienced material changes to its contractual obligations during the six months ended June 30, 2024[123].

Financial Performance & Guidance - Total revenues for 2024 are expected to be between $4 billion and $4.1 billion[8], representing a +6% increase at the guidance midpoint[8, 35] - Adjusted net income (ANI) for 2024 is projected to be between $1.275 billion and $1.350 billion[8], and adjusted EPS is expected to be $19.20 - $20.30[8] - The company anticipates double-digit percentage growth of Xywav, Epidiolex, and Rylaze combined in 2024[8, 13] - Expect high-sodium AG royalty revenue to exceed $200 million in 2024[14] Product Performance - Epidiolex revenues grew 22% year-over-year (YoY)[8, 18] - Xywav revenues grew 13% YoY[8, 14] - Oncology revenues grew 10% YoY[8] - Rylaze revenues grew 6% YoY[8, 21] - Zepzelca revenues grew 15% YoY[8, 24] Pipeline Development - Zanidatamab BLA granted Priority Review by U S FDA with a PDUFA date of November 29, 2024[8, 28] - Phase 3 top-line PFS data in GEA for Zanidatamab is estimated for 2Q25[8] - Phase 3 top-line data readout for Epidyolex in Japan is expected in 2H24[8, 27] - Phase 3 top-line PFS Readout for Zepzelca in 1L ES SCLC combo with Tecentriq is expected by the end of 2024[8, 27]

Financial Data and Key Metrics Changes - Jazz Pharmaceuticals reported its largest revenue quarter ever, exceeding $1 billion in total revenues, driven by strong commercial performance across its diversified portfolio [6][31] - The company achieved a net income of $365 million, representing a 12% increase compared to the same period in 2023 [31] - Cash from operations was approximately $331 million in the second quarter [31] Business Line Data and Key Metrics Changes - In the neuroscience therapeutic area, Xywav net product sales increased by 13% year-over-year to approximately $368 million [6][16] - Epidiolex sales reached approximately $247 million in the quarter, reflecting a 22% increase compared to the same quarter in 2023 [19] - Total oncology revenue for the quarter was approximately $277 million, with Rylaze net product sales of approximately $108 million, a 6% increase from the second quarter of 2023 [21] Market Data and Key Metrics Changes - The total revenue from the Sleep segment, including Xywav and Xyrem, was $485 million during the second quarter, slightly down from approximately $492 million during the same period in 2023 [15] - Approximately 9,925 narcolepsy patients were taking Xywav at the end of the second quarter, a modest increase from the prior quarter [17] - The number of active idiopathic hypersomnia patients on Xywav increased to approximately 3,300, up by about 250 from the prior quarter [18] Company Strategy and Development Direction - The company introduced Vision 2025 to communicate expected growth and diversification away from Xyrem, anticipating substantial growth in its oncology business and the potential for Epidiolex to become a blockbuster product [9][10] - The focus remains on achieving commercial excellence, investing in pipeline development, and maintaining disciplined capital allocation [14] - The company plans to revert to pre-Vision 2025 guidance metrics, indicating a shift in how it communicates future expectations [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of the oxybate business, particularly Xywav, and highlighted strong performance in Epidiolex and oncology [39] - The company is optimistic about upcoming data readouts from late-stage programs, which could serve as significant value inflection points [8][30] - Management emphasized the importance of long-term investments for sustainable growth, balancing current performance with future opportunities [56] Other Important Information - The company has a robust cash and investment balance of approximately $2 billion, providing flexibility for future investments and corporate development opportunities [36] - A new $500 million share repurchase authorization was approved by the board, reflecting the company's commitment to returning value to shareholders [36] Q&A Session Summary Question: Follow-up on Vision 2025 update - Management confirmed that while specific numerical targets for 2025 have been removed, the general trends for revenue growth remain positive, particularly for Xywav and Epidiolex [39] Question: Xywav revenue concerns - Management explained that while patient numbers increased, normalization of support programs impacted revenue, and competition in the market is being managed effectively [41][44] Question: Outlook for Xywav net ads in narcolepsy - Management indicated that the narcolepsy market is not growing as rapidly as idiopathic hypersomnia, but Xywav continues to perform strongly as the treatment of choice [45][46] Question: Corporate development strategy - Management clarified that corporate development remains a vital part of the strategy, focusing on opportunities that can significantly improve standard-of-care and create durable revenue streams [51][52] Question: Time horizon for investor expectations - Management suggested that investors should focus on both current strong performance and long-term growth potential, with a balanced approach to capital allocation [56]

Jazz Pharmaceuticals (JAZZ) came out with quarterly earnings of $5.30 per share, beating the Zacks Consensus Estimate of $4.68 per share. This compares to earnings of $4.51 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 13.25%. A quarter ago, it was expected that this drugmaker would post earnings of $4.14 per share when it actually produced earnings of $2.68, delivering a surprise of -35.27%. Over the last four quarters, th ...

– 15% year-over-year revenue increase from combined key growth drivers: Xywav®, Epidiolex® and Rylaze® – – Oncology revenues grew 10% year-over-year – – Zanidatamab granted Priority Review by U.S. FDA for 2L BTC; PDUFA date of November 29, 2024 – – Near-term, late-stage pipeline catalysts anticipated through 2025 – – Narrowing 2024 total revenue guidance to $4.0 to $4.1 billion – – Affirming GAAP and non-GAAP adjusted net income guidance – DUBLIN, July 31, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasd ...