January 9, 2026 Zanidatamab: Pivotal Phase 3 HERIZON-GEA-01 Trial Results in Gastroesophageal Adenocarcinoma (GEA) Innovating to Transform the Lives of Patients and Their Families Intended for U.S. investor audiences only. Intended for U.S. investor audiences only. 2 January 9, 2026 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 C ...

Core Insights - The Phase 3 HERIZON-GEA-01 trial results indicate that Ziihera (zanidatamab-hrii) in combination with chemotherapy, with or without tislelizumab, is positioned to become the new standard of care for HER2-positive first-line metastatic gastroesophageal adenocarcinoma (GEA) [1][2][4] Efficacy Summary - The trial achieved a median overall survival (OS) of 26.4 months for Ziihera plus tislelizumab and chemotherapy, which is the longest reported in a Phase 3 trial for this indication, showing a greater than seven-month improvement compared to the control arm [2][4][5] - Median progression-free survival (PFS) was over one year, with a 35% reduction in the risk of disease progression or death compared to trastuzumab plus chemotherapy, representing a more than four-month improvement [4][5] - The objective response rate (ORR) was 70.7% for Ziihera plus tislelizumab and chemotherapy, compared to 65.7% for the control arm [5] Safety Profile - The safety profile of Ziihera in combination with chemotherapy was consistent with known effects of HER2-directed therapy, with no new safety signals identified [6][7] - Grade 3 treatment-related adverse events (TRAEs) were reported at 71.8% for Ziihera plus tislelizumab and chemotherapy, and 59.0% for Ziihera plus chemotherapy [6] - The most common Grade 3 TRAE was diarrhea, occurring in 24.5% of patients receiving Ziihera plus tislelizumab and chemotherapy [6] Future Developments - Jazz Pharmaceuticals plans to submit Ziihera for FDA approval based on these results and is also evaluating Ziihera in other HER2-driven tumor types, including HER2-positive metastatic breast cancer [7][8] - An investor webcast is scheduled to discuss the Ziihera data presented at the ASCO GI symposium [8] Trial Details - The HERIZON-GEA-01 trial was a global, randomized, open-label study involving 914 patients across more than 30 countries, comparing Ziihera plus chemotherapy (with or without tislelizumab) to trastuzumab plus chemotherapy [9]

Core Insights - Jazz Pharmaceuticals will participate in key investor events in January 2026, including a webcast to review Phase 3 trial results for zanidatamab [1][2] Group 1: Upcoming Events - The company will host an investor webcast on January 9, 2026, at 6:30 a.m. PT / 3:30 p.m. GMT to discuss results from the Phase 3 zanidatamab HERIZON-GEA-01 trial, featuring commentary from senior management and Dr. Geoffrey Ku [1] - Jazz Pharmaceuticals will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, at 11:15 a.m. PST / 7:15 p.m. GMT, where CEO Renee Gala will provide a company strategy overview and business update [2] Group 2: Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing innovative medicines for serious diseases, with a diverse portfolio that includes therapies for sleep disorders, epilepsy, and cancer treatments [3] - The company is headquartered in Dublin, Ireland, and has research and development laboratories, manufacturing facilities, and employees in multiple countries dedicated to serving patients worldwide [3]

Core Insights - Jazz Pharmaceuticals reported strong Q3 2025 earnings, with adjusted EPS of $8.13, surpassing estimates by 24% year over year [2][3] - Total revenues reached $1.13 billion, a 7% increase year over year, also exceeding consensus estimates [2][3] Financial Performance - Net product sales increased nearly 8% year over year to $1.06 billion, beating estimates [3] - Royalty revenues from high-sodium oxybate authorized generic decreased by 9% year over year to $53 million, missing estimates [3] - Neuroscience product sales rose 10% to $774 million, with Xywav sales up 11% to over $431 million [4][5] - Sales of Epidiolex/Epidyolex increased by 20% to about $303 million, driven by volume growth [5] - Oncology product sales rose 1% to about $288 million, with Rylaze/Enrylaze sales at $100 million, also up 1% [7][8] Cost and Guidance - Adjusted SG&A expenses rose 59% year over year to $460 million, primarily due to litigation settlements [11] - Jazz revised its 2025 revenue guidance to $4.18-$4.28 billion, indicating a 3% year-over-year increase at the midpoint [12] - Adjusted EPS guidance was significantly raised to $7.65-$8.45 from the previous $4.80-$5.60 [14] Market Outlook - The consensus estimate for Jazz has shifted upward by 8.54% in the past month, indicating positive investor sentiment [15] - Jazz holds a Zacks Rank 3 (Hold), suggesting an expectation of in-line returns in the coming months [17] Industry Comparison - Jazz is part of the Zacks Medical - Biomedical and Genetics industry, which has seen Regeneron report a slight revenue increase of 0.9% year over year [19] - Regeneron is expected to post a year-over-year EPS decline of 11.8% for the current quarter, reflecting broader industry challenges [20]

Core Insights - Jazz Pharmaceuticals announced the presentation of eight abstracts, including four late-breaking ones, at the American Epilepsy Society (AES) 2025 Annual Meeting, focusing on the efficacy of Epidiolex (cannabidiol) in treating rare forms of epilepsy [1][2][3] Group 1: EpiCom Trial Results - The EpiCom trial, a Phase 3b/4 study, showed promising reductions in behavioral problems associated with tuberous sclerosis complex (TSC) after 26 weeks of Epidiolex treatment, as indicated by improvements in TAND-SQ and ABC subscale scores [2][3] - The trial utilized novel endpoints that focused on individualized outcomes, addressing the specific problematic behaviors identified by caregivers and clinicians [3] Group 2: Additional Highlights from AES 2025 - A late-breaking poster presented results from a Phase 1 study that found no pharmacokinetic interactions between Epidiolex and cenobamate when administered together [4] - Preclinical data demonstrated a novel synergistic pharmacodynamic interaction between Epidiolex and cenobamate in a mouse model of seizures [4] - Real-world effectiveness data indicated that initiating Epidiolex in CBD-naïve patients with Dravet Syndrome, Lennox-Gastaut Syndrome, or TSC led to reduced polypharmacy and healthcare resource utilization after 12 months [4] - A post-hoc analysis from the Expanded Access Program showed that Epidiolex treatment was associated with reductions in seizure frequency in patients with developmental and epileptic encephalopathies [4] Group 3: Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing innovative medicines for serious diseases, including epilepsy, with a commitment to addressing the needs of patients with limited therapeutic options [21]

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Core Insights - Jazz Pharmaceuticals announced the acceptance of two abstracts featuring key data for Ziihera at the ASCO GI Symposium, highlighting its expanding clinical profile in HER2-driven gastrointestinal cancers [1][2] Group 1: HERIZON-GEA-01 Trial Results - The Phase 3 HERIZON-GEA-01 trial results for Ziihera in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) were accepted as a late-breaking presentation [1] - Ziihera plus chemotherapy and Ziihera plus tislelizumab demonstrated statistically significant improvements in progression-free survival (PFS) compared to the control arm [2] - Ziihera plus tislelizumab also showed significant improvements in overall survival (OS), while Ziihera plus chemotherapy indicated a strong trend toward statistical significance for OS [2] Group 2: Upcoming Webcast and Presentations - Jazz Pharmaceuticals will host an investor webcast on January 9, 2026, to review the Ziihera data presented at ASCO GI [3] - The webcast will feature commentary from senior management and a physician from Memorial Sloan Kettering Cancer Center [3] Group 3: Background on GEA and BTC - Gastroesophageal adenocarcinoma (GEA) is the fifth most common cancer globally, with a poor prognosis and a five-year survival rate of less than 30% for gastric cancer [8] - Biliary tract cancer (BTC) is rare but aggressive, with HER2 overexpression observed in approximately 26% of patients, leading to worse prognosis [11][9] Group 4: Ziihera Overview - Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that reduces HER2 expression on tumor cells, inducing tumor growth inhibition [12] - The FDA granted accelerated approval for Ziihera for previously treated HER2-positive BTC based on overall response rate and duration of response [14]

Core Insights - Jazz Pharmaceuticals participated in the Citi Annual Global Healthcare Conference, highlighting its presence in the biopharma sector [1] - Philip Johnson, Executive VP and CFO of Jazz Pharmaceuticals, introduced new team members and emphasized the importance of investor relations [2] Company Overview - Jazz Pharmaceuticals is actively engaging with investors and stakeholders at industry conferences to enhance visibility and communication [1][2] - The company has recently appointed John Bluth as the new Head of Investor Relations, indicating a focus on strengthening investor engagement [2] Financial Guidance - The discussion referenced guidance from the November 6, 3Q earnings call, suggesting that the company is maintaining transparency regarding its financial outlook [3]

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]