Jazz Pharmaceuticals (NasdaqGS:JAZZ) FY Conference January 13, 2026 02:15 PM ET Company ParticipantsRob Iannone - CMOPhilip Schlom - CFORenée Galá - CEOConference Call ParticipantsNone - AnalystJessica Fye - AnalystJessica FyeGreat. Good afternoon, everyone. My name is Jessica Fye. I'm a biotech analyst at JPMorgan, and we're continuing the 44th Annual Healthcare Conference today with Jazz. First, you're going to hear a presentation from the company CEO, and then we're going to go into some Q&A. So if you'r ...

January 2026 44th Annual J.P. Morgan Healthcare Conference Redefining Possibilities in Rare Disease Renee Gala, President & CEO 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, including the ability of the Company's portfolio to drive long-term shareholder value; ...

U.S. President Donald Trump sits in the Oval Office to sign executive orders, at the White House in Washington, D.C., U.S., Dec. 18, 2025.President Donald Trump signed an executive order Thursday directing federal agencies to reclassify marijuana, loosening long-standing restrictions on the drug and marking the most consequential shift in U.S. cannabis policy in more than half a century.The order, once finalized by the Drug Enforcement Administration, moves cannabis out of Schedule I classification — the mo ...

In this articleTLRYWEED-CATarek Adieh, of Tampa, Florida, looks at cannabis flower from wholesaler Dep Kings at CHAMPS Trade Show at the Palmer Events Center Thursday, Sept. 11, 2025. Jay Jannar | Hearst Newspapers | Getty ImagesPresident Donald Trump is expected to sign an executive order this week that would broadly expand access to cannabis. Industry advocates, executives and researchers who spoke to CNBC said the changes would come with big implications for both consumers and the health care industry. T ...

Financial Data and Key Metrics Changes - The company reported record revenues of $1.13 billion for the third quarter, representing a 7% increase year-over-year [3] - The guidance for revenue was narrowed, reflecting strong performance and disciplined expense management, with an increase in ANI and EPS guidance [4] - A deferred tax asset of $206 million was recognized in the third quarter related to the Chimerix acquisition, which will reduce future tax liabilities [5] - The company ended the quarter with approximately $2 billion in cash and investments, and generated about $1 billion in cash flow for the first nine months of the year [5] Business Line Data and Key Metrics Changes - Epidiolex and Xywav, the two largest brands, showed strong growth, contributing significantly to the overall revenue increase [3] - Xywav has been particularly successful in the idiopathic hypersomnia (IH) market, with 325 new patient ads in IH compared to 125 in narcolepsy during the most recent quarter [18] - Epidiolex is on track to achieve blockbuster status, with an 11% growth year-to-date, needing only 3% growth to reach that milestone [24] Market Data and Key Metrics Changes - The company is experiencing growth in the idiopathic hypersomnia market, which is expected to be about half the size of the narcolepsy market [19] - The competitive landscape in small cell lung cancer is evolving, with new entrants and significant advancements in treatment options [39] - The company anticipates potential headwinds for Xywav in 2026 due to the expected entry of generic versions of Xyrem [20][21] Company Strategy and Development Direction - The company is focused on business development opportunities in oncology and epilepsy, with a strategic fit seen in the Chimerix acquisition [10][15] - There is an emphasis on expanding the presence in brain cancer and glioma, leveraging the capabilities gained from the Chimerix acquisition [11] - The company is open to various transaction types, including licensing deals, to enhance its portfolio [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong momentum heading into 2026, particularly with the performance of Epidiolex and Xywav [3][4] - The company is aware of potential challenges from generic competition but believes it is well-positioned due to the unique attributes of its products [20][21] - Management highlighted the importance of educating physicians about the benefits of using Xywav for IH patients to drive market penetration [23] Other Important Information - The company has made significant investments in patient identification tools and nurse navigator programs to enhance the patient experience with Epidiolex [26][27] - The initial launch of Midaso has exceeded expectations, with strong uptake and positive feedback from physicians [43][45] - The company is actively working on expanding awareness and testing for patients eligible for Midaso treatment [47] Q&A Session Summary Question: What is the rationale behind the Chimerix deal? - The acquisition addresses a significant unmet need in a rare form of glioma and aligns with the company's capabilities and expertise [10] Question: How is the company approaching the SAN2355 licensing agreement? - The licensing agreement aims to build on the company's presence in epilepsy, leveraging the attributes of the Saniona molecule [14] Question: What are the growth drivers for Epidiolex? - Key drivers include patient identification initiatives, nurse navigator programs, and increasing awareness of both seizure and non-seizure benefits [24][26] Question: How is the company positioned in the small cell lung cancer market? - The company is optimistic about Zepzelca's potential in first-line maintenance settings, despite increased competition [39] Question: What is the company's strategy regarding business development? - The company is focused on later-stage assets and is open to various transaction types, including acquisitions and licensing deals [16][62]

Financial Data and Key Metrics Changes - The company reported record revenues of $1.13 billion for the third quarter, representing a 7% increase year-over-year [3] - The guidance for revenue was narrowed, reflecting strong performance and disciplined expense management, with an increase in ANI and EPS guidance [4] - A deferred tax asset of $206 million was recognized in the third quarter related to the Chimerix acquisition, which will reduce future tax liabilities [5] - The company ended the quarter with approximately $2 billion in cash and investments, and generated about $1 billion in cash flow for the first nine months of the year [5] Business Line Data and Key Metrics Changes - Epidiolex and Xywav, the two largest brands, showed strong growth driven by demand, contributing significantly to overall revenue [3] - Xywav has been particularly successful in the idiopathic hypersomnia (IH) market, with 325 new patient ads in IH compared to 125 in narcolepsy [18] - Epidiolex is on track to achieve blockbuster status, with an 11% growth year-to-date and a focus on patient titration and nurse navigator programs to enhance persistence [24][26] Market Data and Key Metrics Changes - The market for idiopathic hypersomnia is estimated to be about half the size of narcolepsy, indicating potential for growth as awareness increases [19] - The company anticipates the entry of generic versions of Xyrem in 2026, which could impact Xywav depending on the number and pricing of generics [20][21] - In the small cell lung cancer market, Zepzelca is positioned to become a standard of care, with significant advancements noted in recent medical meetings [39] Company Strategy and Development Direction - The company is focused on business development opportunities in oncology and epilepsy, with a strategic fit seen in the Chimerix acquisition [10][15] - Jazz Pharmaceuticals aims to build on its presence in brain cancer and glioma, leveraging the expertise gained from the Chimerix team [12] - The company is open to various transaction types, including licensing deals, to enhance its portfolio and address unmet medical needs [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong momentum heading into 2026, particularly with the performance of Epidiolex and Xywav [3][4] - The company is aware of potential headwinds from generic competition and payer actions but feels well-positioned to mitigate these risks [20][21] - There is a strong focus on increasing awareness and understanding of the benefits of products like Xywav and Epidiolex among healthcare providers [23][24] Other Important Information - The company has made significant investments in patient identification tools and commercial initiatives to support the growth of Epidiolex and Xywav [26][27] - Jazz Pharmaceuticals is exploring opportunities in rare and orphan diseases, aiming to leverage its existing capabilities in new therapeutic areas [59] Q&A Session Summary Question: What was the rationale behind the Chimerix acquisition? - The acquisition addressed a significant unmet need in a rare form of glioma and provided strong patent protection, aligning with the company's capabilities and expertise [10][11] Question: How is the company addressing the growth in the epilepsy market? - The company is leveraging its leadership position with Epidiolex and exploring new opportunities to enhance its presence in epilepsy treatments [14][15] Question: What are the growth drivers for Xywav in the sleep franchise? - The majority of new patient ads are coming from the IH indication, with a strong opportunity for continued growth as awareness increases [18][19] Question: How does the company view the competitive landscape in oncology? - The company acknowledges the competitive nature of the oncology market but is optimistic about the potential for Zepzelca and other products to capture market share [39][40] Question: What is the company's approach to managing potential tariff impacts? - The company has built inventory in the U.S. to buffer against tariff impacts and is actively working to mitigate exposure [35][36]

Financial Data and Key Metrics Changes - The company reported record revenues of $1.13 billion for Q3 2025, representing a 7% increase year-over-year [3] - The guidance for revenue was narrowed, with an increase in ANI and EPS guidance due to strong momentum and disciplined expense management [4] - A deferred tax asset of $206 million was recognized related to the Chimerix acquisition, which will reduce future tax liabilities [5] - The company ended the quarter with approximately $2 billion in cash and investments, and generated about $1 billion in cash flow for the first nine months of the year [5] Business Line Data and Key Metrics Changes - Epidiolex and Xywav, the two largest brands, showed strong growth, contributing significantly to overall revenue [3] - Xywav has been particularly successful in the idiopathic hypersomnia (IH) market, with 325 new patient ads in IH compared to 125 in narcolepsy [18] - Epidiolex is on track to achieve blockbuster status, with an 11% growth year-to-date and a need for only 3% growth to reach that milestone [24] Market Data and Key Metrics Changes - The company is seeing a growing patient base in the IH market, which is expected to continue as awareness increases [19] - The competitive landscape in the small cell lung cancer market is evolving, with new entrants and significant advancements in treatment options [39] - The company anticipates potential headwinds for Xywav in 2026 due to the introduction of generic versions of Xyrem [20][21] Company Strategy and Development Direction - The company is focused on business development opportunities in oncology and epilepsy, with a strategic emphasis on areas with high unmet needs [14][59] - The acquisition of Chimerix is seen as a strategic fit, providing access to a therapy for a rare form of glioma [10] - The company aims to build upon its presence in brain cancer and glioma, leveraging the expertise gained from the Chimerix acquisition [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance of zanidatamab in clinical trials, positioning it as a potential first-line treatment for HER2-positive gastric cancer [6] - The company is aware of the challenges posed by competition in the narcolepsy market but has not experienced net patient losses, indicating strong product demand [18] - Management is cautiously optimistic about the impact of potential policy changes and tariffs, indicating a manageable risk profile moving forward [35] Other Important Information - The company has implemented initiatives to improve patient identification and treatment persistence for Epidiolex, including a Nurse Navigator program [26][28] - The initial launch of Midaso has exceeded expectations, with $11 million in net sales recognized in Q3 2025 after only a few weeks on the market [43][45] - The company is exploring opportunities in rare and orphan diseases beyond its current focus areas, indicating a willingness to expand its therapeutic portfolio [59] Q&A Session Summary Question: What is the rationale behind the Chimerix acquisition? - The acquisition was driven by the unmet need in treating a rare form of glioma, with the asset showing durable patient responses and strong patent protection [10] Question: How is the company addressing the competition in the narcolepsy market? - The company has not experienced net patient losses in narcolepsy despite competition, indicating the strong benefits of Xywav [18] Question: What are the growth drivers for Epidiolex? - Key drivers include improved patient identification, nurse navigator support, and increased awareness of both seizure and non-seizure benefits [24][26] Question: What is the company's strategy regarding oncology? - The company is focused on building its oncology portfolio through acquisitions and partnerships, with a particular emphasis on rare diseases [59] Question: How does the company view the impact of potential tariffs? - Management believes the potential impact from tariffs is manageable, with proactive measures taken to mitigate risks [35]

Core Insights - JAZZ Pharmaceuticals is an unconventional player in the cannabis sector, having entered the market through the acquisition of GW Pharmaceuticals in 2021, which added the FDA-approved CBD drug Epidiolex to its portfolio [1][2] - The company is well-positioned for long-term gains as the medical cannabis market evolves and regulatory clarity improves [2] Epidiolex's Contribution - Epidiolex has become a significant revenue contributor, accounting for a quarter of JAZZ's total revenues [3] - In the first nine months of 2025, Epidiolex generated over $772 million in product sales, reflecting an 11% year-over-year increase [4] - The global medical cannabis market is projected to exceed $130 billion by 2032, providing JAZZ with a unique opportunity due to its established FDA-approved product [5] Diverse Product Lineup - JAZZ has a diverse product lineup beyond cannabis, including drugs for neuroscience and oncology [6] - Xywav, a low-sodium formulation for narcolepsy, is a key product that offers advantages over its predecessor, Xyrem [7] - The oncology segment includes six drugs that now contribute over 26% to JAZZ's topline, driven by new launches and increased market share [8] Pipeline Developments - JAZZ is focused on expanding the labels of its oncology drugs, with promising results for Ziihera in treating HER2+ gastroesophageal adenocarcinoma [9] - Despite setbacks in its pipeline, including the discontinuation of suvecaltamide and underwhelming results for JPZ150, the company continues to explore options for its drug development [12][13] Stock Performance and Outlook - JAZZ's stock has surged 46% year-to-date, outperforming the industry average of 20% [14] - EPS estimates for 2025 and 2026 have trended upward, indicating a stronger outlook compared to other cannabis-focused companies [15] - The company offers a diversified revenue base, making it suitable for investors seeking balanced biotech exposure rather than a direct cannabis investment [16][17]

Financial Data and Key Metrics Changes - Jazz Pharmaceuticals reported total revenues of $1.126 billion for Q3 2025, representing a 7% increase compared to Q3 2024 [21] - Adjusted net income (ANI) for the quarter was $501 million, influenced by various factors including litigation settlements and the Chimerix acquisition [22] - The company narrowed its 2025 revenue guidance to a range of $4.175-$4.275 billion, reflecting increased confidence in its outlook [7][22] Business Line Data and Key Metrics Changes - Revenue from the sleep therapeutic area, including Xywav and Xyrem, was $520 million, with Xywav net product sales growing 11% year-over-year to $431 million [9][12] - Epidiolex net product sales reached $303 million, a 20% increase compared to Q3 2024, driven by 10% volume growth [12][22] - Rylaze net product sales were $100 million, a 1% increase year-over-year, while Zepzelca sales were approximately $79 million, an 8% decrease due to competitive dynamics [14][15] Market Data and Key Metrics Changes - The launch of Modeso generated $11 million in net product sales within two weeks of its accelerated approval, indicating strong market uptake [16] - The company anticipates potential entry of generic versions of Xyrem in 2026, which could impact Xywav revenue [11][39] Company Strategy and Development Direction - Jazz Pharmaceuticals aims to strengthen its portfolio through corporate development, as evidenced by the acquisition of Chimerix and the licensing agreement with Saniona [6][7] - The company is focused on executing its strategy to maximize patient impact and shareholder value, with a strong emphasis on innovation in rare diseases and oncology [7][25] - The management highlighted the importance of differentiation in the market, particularly for Xywav as the only low-sodium oxybate [12][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the competitive landscape, particularly with the anticipated entry of generics [39][66] - The management team emphasized the importance of maintaining strong access to Xywav and the differentiated profile of its products [12][43] - Future milestones include sharing top-line results from the phase III GEA trial of Zanidatamab, which is expected to be a significant event for the company [25] Other Important Information - The company has reached settlement agreements regarding the Xyrem antitrust litigation, allowing it to focus on strategic execution [7] - Jazz Pharmaceuticals welcomed Dr. Ted Love to its Board of Directors, enhancing its leadership capabilities in the biopharmaceutical industry [7] Q&A Session Summary Question: Can you talk about how KD7 is best-in-class? - The management highlighted that KD7 has specificity for KCNQ2 and KCNQ3, differentiating it from other molecules that may cause off-target toxicity [30] Question: Can you quantify the benefit to gross to net for Epidiolex? - The revenue growth for Epidiolex was boosted by volume growth and refinements in accrual rates, with a majority of the difference between volume and revenue growth attributed to these refinements [31][32] Question: How do you view the potential for generic entrants in 2026? - The management acknowledged uncertainty regarding the number of generics entering the market and their pricing, which could disrupt Xywav revenue [39][52] Question: What strategies will be employed to defend against competitive threats to the sleep franchise? - The company plans to continue emphasizing the differentiation of Xywav and maintain strong engagement with healthcare providers [42][43] Question: How confident is the team regarding the FDA's acceptance of the Horizon GEA trial design? - The management confirmed alignment with the FDA on the trial design, emphasizing the representativeness of the enrolled patient population [46] Question: What is the expected cadence of uptake for Rylaze and Zepzelca? - Rylaze has seen strong uptake with high awareness among healthcare providers, while Zepzelca's first-line use is still early to assess [71][72]

Financial Performance - Total revenues are projected to be between $4175 million and $4275 million[31] - Non-GAAP Adjusted Net Income (ANI) is guided to be between $475 million and $525 million[31] - Adjusted Earnings Per Share (EPS) is expected to be in the range of $765 to $845[31] - Cash reserves at the end of 3Q25 stand at $2 billion[32] - September Year-To-Date (YTD) operating cash flow reached $993 million[32] - Neuroscience revenues accounted for 43% of the total, with Xywav revenues at $431 million, showing an 11% year-over-year growth[88] - Oncology revenues contributed 48%, amounting to $288 million, a 1% increase year-over-year[88] Product Performance - Epidiolex revenues grew by 20% year-over-year, reaching $303 million in 3Q25[17, 46] - Total sleep therapeutic area revenue was $520 million in 3Q25[38] - Rylaze revenues increased by 1% year-over-year, totaling $100 million in 3Q25[51, 52] - Modeyso achieved $11 million in net product sales in 3Q25 following its launch[69]