Jazz Pharmaceuticals Plc · NASDAQ:JAZZ

Jazz Pharmaceuticals — Investor Presentation (January 2026)

39 slides from Jazz Pharmaceuticals's investor presentation, Jan 9, 2026

  1. Slide 1: Zanidatamab: Pivotal Phase 3 HERIZON-GEA-01 Trial Results in GEA

    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.

  2. Slide 2: Caution Concerning Forward-Looking Statements

    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 development, regulatory and commercialization strategy; the adv

  3. Slide 3: Agenda

    Agenda Introduction and Overview Renee Gala President and Chief Executive Officer Results from the Phase 3 HERIZON-GEA-01 Trial and Clinical Perspective Geoffrey Ku, M.D. Associate Attending Physician on the Gastrointestinal Oncology Service in the Department of Medicine at Memorial Sloan Kettering

  4. Slide 4: Introduction and Overview

    Introduction and Overview Renee Gala President and Chief Executive Officer Intended for U.S. investor audiences only.

  5. Slide 5: Phase 3 HERIZON-GEA-01 Data Presented at ASCO GI

    Phase 3 HERIZON-GEA-01 Data Presented at ASCO GI Zanidatamab + chemotherapy ± tislelizumab for first-line HER2-positive locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma: Primary analysis from HERIZON-GEA-01 Intended for U.S. investor audiences only. 5 January 9, 2026

  6. Slide 6: Geoffrey Y. Ku, M.D.

    Geoffrey Y. Ku, M.D. Associate Attending Physician on the Gastrointestinal Oncology Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center Geoffrey Ku, MD is a Medical Oncologist who specializes in the treatment of malignancies of the gastrointestinal tract at Memorial Sloan

  7. Slide 7: Zanidatamab + chemotherapy ± tislelizumab: Primary analysis from HERIZON-GEA-01

    Zanidatamab + chemotherapy ± tislelizumab for first-line HER2-positive locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma: Primary analysis from HERIZON-GEA-01 Elena Elimova1, Sun Young Rha2, Kohei Shitara3, Tianshu Liu4, Josep Tabernero5, Keun-Wook Lee6, Michael Schenker7

  8. Slide 8: Key Takeaway Points

    Key Takeaway Points HERIZON-GEA-01 supports zanidatamab as a new standard in HER2-targeting agents, potentially replacing trastuzumab, as well as the use of tislelizumab in 1L HER2+ mGEA Progression-Free Survival and Overall Survival • Statistically significant ~35% reduction in the risk of disease

  9. Slide 9: Background

    Background • Outcomes with current SoC for 1L HER2+ mGEA remain modest, with an mPFS of <1 year and mOS of <2 years1-7 • Zanidatamab is a dual HER2-targeted bispecific IgG1-like antibody that binds to extracellular domains 2 and 4 on HER2 in a trans configuration8 ▪ This biparatopic binding enables

  10. Slide 10: HERIZON-GEA-01 Study Design

    HERIZON-GEA-01 Study Design Global phase 3 trial of zanidatamab + chemotherapy ± tislelizumab vs trastuzumab + chemotherapy in previously untreated patients with HER2+ mGEA Key Eligibility Criteria Arm A: Trastuzumab + • Age ≥18 years chemotherapya • Unresectable, locally advanced, recurrent or Dual

  11. Slide 11: Statistical Design

    Statistical Design • Dual primary endpoints (PFS and OS): Analyzed in the intent-to-treat population using log-rank tests with a 2-sided α = 0.05 • Primary PFS analysis: After target event count was reached and patients had ≥7 months of follow-up • First interim OS analysis: Performed at the time of

  12. Slide 12: Patient Disposition

    Patient Disposition A total of 914 patients were randomized, and median follow-up was >2 years Randomized N = 914 Zanidatamab + CT Zanidatamab + tislelizumab + CT Trastuzumab + CT n = 304; 300 patients treateda n = 302; 299 patients treateda n = 308; 302 patients treated Ongoing treatment, n = 69 (2

  13. Slide 13: Baseline Demographics and Disease Characteristics

    Baseline Demographics and Disease Characteristics Demographics and clinical characteristics were balanced across all 3 treatment arms Zanidatamab + Zanidatamab + Zanidatamab + CT tislelizumab + CT Trastuzumab + CT Zanidatamab + CT tislelizumab + CT Trastuzumab + CT (n = 304) (n = 302) (n = 308) (n =

  14. Slide 14: Primary Endpoint: PFS per BICR (Zanidatamab + CT)

    Primary Endpoint: PFS per BICR Statistically significant and clinically meaningful improvement in PFS with zanidatamab + CT vs trastuzumab + CT (>4-month prolongation in median PFS) 100 Zanidatamab + CT Trastuzumab + CT Zanidatamab + CT Median PFS 12.4 (9.8–14.5) 8.1 (7.0–8.9) Progression-free survi

  15. Slide 15: Primary Endpoint: PFS per BICR (Zanidatamab + Tislelizumab + CT)

    Primary Endpoint: PFS per BICR Statistically significant and clinically meaningful improvement in PFS with zanidatamab + tislelizumab + CT vs trastuzumab + CT (>4-month prolongation in median PFS) 100 Zanidatamab + tislelizumab + CT Trastuzumab + CT Zanidatamab + tislelizumab + CT Median PFS 12.4 (9

  16. Slide 16: PFS in Key Prespecified Subgroups

    PFS in Key Prespecified Subgroups Improvements in PFS were generally consistent across major prespecified subgroups Events/patients Zanidatamab + Subgroup Category tislelizumab + CT Zanidatamab + CT Trastuzumab + CT All patients 154/302 160/304 196/308 0.63 (0.51–0.78) 0.65 (0.52–0.81) Age, years <6

  17. Slide 17: Primary Endpoint: Overall Survival (Zanidatamab + CT)

    Primary Endpoint: Overall Survival At this interim analysis, there was a strong trend toward significance for OS favoring zanidatamab + CT vs trastuzumab + CT (5-month improvement in median OS) 100 Zanidatamab + CT Trastuzumab + CT Median OS Zanidatamab + CT (95% CI), mo 24.4 (20.4–30.0) 19.2 (16.8–

  18. Slide 18: Primary Endpoint: Overall Survival (Zanidatamab + Tislelizumab + CT)

    Primary Endpoint: Overall Survival Zanidatamab + tislelizumab + CT demonstrated a statistically significant and clinically meaningful OS benefit with a >7-month improvement in median OS vs trastuzumab + CT Zanidatamab + 100 tislelizumab + CT Trastuzumab + CT Median OS Zanidatamab + tislelizumab + CT

  19. Slide 19: OS in Key Prespecified Subgroups

    OS in Key Prespecified Subgroups Improvements in OS occurred across major prespecified subgroups, including regions and PD-L1 TAP scores Events/patients Zanidatamab + tislelizumab + Subgroup Category CT Trastuzumab + CT All patients 134/302 170/308 0.72 (0.57–0.90) Age, years <65 68/163 99/162 0.60

  20. Slide 20: Key Secondary Endpoint: Antitumor Activity

    Key Secondary Endpoint: Antitumor Activity Responses were deeper and more durable in the zanidatamab-containing arms vs the trastuzumab + CT arm 100 Confirmed ORR in patients with measurable disease 80 69.6% 70.7% 95% CI (63.9–75.0) 95% CI (65.0–76.0) 65.7% 95% CI (59.9–71.2) CR CR CR cORR (%) 60 Me

  21. Slide 21: Safety Summary

    Safety Summary The safety profile was generally manageable, and no unexpected safety signals were identified Zanidatamab + CT Zanidatamab + tislelizumab + CT Trastuzumab + CT (n = 305)a (n = 294)a (n = 302) Duration of treatment, median (IQR), weeks 31.0 (53.8) 43.1 (56.7) 30.0 (32.2) Any-grade TEAE

  22. Slide 22: Common TRAEs (≥20% of Patients in Any Arm)

    Common TRAEs (≥20% of Patients in Any Arm) Diarrhea was the most common TRAE in all treatment arms 100 90 Zani + CT Zani + TIS + CT Tras + CT 82% (n = 305)a (n = 294)a (n = 302) 80 76% Grade 1–2    70 Grade ≥3    60 Patients (%) 50% 51% 50 48% 42% 40% 39% 38% 38% 37% 40 36% 35% 31% 32% 29% 30%

  23. Slide 23: Treatment-Emergent Diarrhea

    Treatment-Emergent Diarrhea Treatment-emergent diarrhea generally occurred early in treatment and resolved within 3 weeks, and few patients discontinued zanidatamab due to diarrhea Zanidatamab + CT Zanidatamab + tislelizumab + CT (n = Trastuzumab + CT (n = 305)a 294)a (n = 302) Treatment-related dia

  24. Slide 24: Discussion

    Discussion • HERIZON-GEA-01 is the first phase 3 study in mGEA to demonstrate a median PFS >1 year and a median OS >2 years • These findings support zanidatamab as a promising new standard in HER2-targeting agents, with potential to replace trastuzumab in first-line treatments for HER2+ mGEA • The c

  25. Slide 25: Acknowledgments

    Acknowledgments The authors would like to thank all the patients and their families as well as all the investigators, clinical trial researchers, personnel, and staff who contributed to or participated in the trial • Clinical research was funded by Jazz Pharmaceuticals in collaboration with BeOne Me

  26. Slide 26: Zanidatamab: Shifting Treatment Paradigm

    Zanidatamab: Shifting Treatment Paradigm Rob Iannone, M.D., M.S.C.E. Executive Vice President, Global Head of Research & Development, Chief Medical Officer Intended for U.S. investor audiences only.

  27. Slide 27: Zanidatamab: Unique MOA Drives Compelling Clinical Profile and Patient Outcomes

    Zanidatamab: Unique MOA Drives Compelling Clinical Profile and Patient Outcomes Unique dual-targeting Compelling and Combination data durable responses Favorable supports ability to HER2 bispecific help drive improved tolerability with combine with other antibody provides patient outcomes in managea

  28. Slide 28: Clinical Benchmarks: Primary Endpoints of OS and PFS

    Zanidatamab + Tislelizumab + Chemo in 1L HER2+ GEA: Clinical Benchmarks Primary Endpoints of OS and PFS for Intent-to-Treat Population mOS mPFS 26.4m 24.4m HR = 0.72 Immature at this analysis2 12.4m 12.4m HR = 0.63 HR = 0.65 20.0m 10.0m HR = 0.80 HR = 0.73 13.8m 6.7m HR = 0.74 HR = 0.71 Zanidatamab

  29. Slide 29: Clinical Benchmarks: Progression-Free Survival Kaplan-Meier Plot

    Zanidatamab + Tislelizumab + Chemo in 1L HER2+ GEA: Clinical Benchmarks Progression-Free Survival Kaplan-Meier Plot 1.00 HERIZON-GEA-01 trastuzumab + chemo HERIZON-GEA-01 zanidatamab + chemo HERIZON-GEA-01 zanidatamab + tislelizumab + chemo KEYNOTE-811 pembrolizumab + trastuzumab + chemo KEYNOTE-811

  30. Slide 30: Clinical Benchmarks: Overall Survival Kaplan-Meier Plot

    Zanidatamab + Tislelizumab + Chemo in 1L HER2+ GEA: Clinical Benchmarks Overall Survival Kaplan-Meier Plot 1.00 HERIZON-GEA-01 trastuzumab + chemo HERIZON-GEA-01 zanidatamab + chemo HERIZON-GEA-01 zanidatamab + tislelizumab + chemo KEYNOTE-811 pembrolizumab + trastuzumab + chemo KEYNOTE-811 trastuzu

  31. Slide 31: Clinical Benchmarks: Secondary Endpoints of cORR and DOR

    Zanidatamab + Tislelizumab + Chemo in 1L HER2+ GEA: Clinical Benchmarks Secondary Endpoints of cORR and DOR cORR mDOR 70.7% 69.6% 72.6% 20.7m 47% 14.3m 11.3m 6.9m Zanidatamab + Zanidatamab + Trastuzumab + Trastuzumab + Zanidatamab + Zanidatamab + Trastuzumab + Trastuzumab + Tislelizumab + Chemo 1,2

  32. Slide 32: Key Ongoing Zanidatamab Clinical Trials

    Key Ongoing Zanidatamab Clinical Trials PHASE 1 PHASE 2 PHASE 3 PHASE 4 / REGULATORY Recent / Upcoming Milestones Phase 3 1L GEA (pivotal) Plan to submit sBLA in 1H26 Phase 3 1L BTC Phase 3 confirmatory trial in 1L BTC ongoing Phase 3 BC in patients who have progressed on previous T-DXd treatment Ph

  33. Slide 33: Zanidatamab: Commercial Perspective

    Zanidatamab: Commercial Perspective Sam Pearce Executive Vice President and Chief Commercial Officer Intended for U.S. investor audiences only.

  34. Slide 34: GEA Represents a Significant Unmet Need

    GEA Represents a Significant Unmet Need <10% five-year survival rate in mGEA1 GEA opportunity of ~63,000 cases annually 2 in U.S., Europe3 and Japan U.S. ~8,000 HER2+ GEA patients annually2 Intended for U.S. investor audiences only. 34 January 9, 2026

  35. Slide 35: Establish Ziihera as the HER2+ Standard of Care Regardless of PDL1 Status

    Establish Ziihera as the HER2+ Standard of Care Regardless of PDL1 Status 1 2 3 Establish Belief in Ziihera Leverage Existing Footprint and Utilize Existing Access Based on Unprecedented Infrastructure to Accelerate Infrastructure Clinical Results Launch • Practice-changing results supporting Ziiher

  36. Slide 36: Zanidatamab: De-Risked Near-Term Opportunity with $2B+ Peak Potential

    Zanidatamab: De-Risked Near-Term Opportunity with $2B+ Peak Potential Goal to be the HER2-targeted agent of choice • Data presented at ASCO GI January 8th • Rapid submission to NCCN Guidelines Other HER2-Expressing • Plan to submit sBLA for 1L HER2+ mGEA in 1H26 Cancers Breast Cancer Broad potential

  37. Slide 37: Thank You

    Thank You … to the numerous patients and their families who participated in our clinical development program. … to the clinical investigators, physicians, nurses, site coordinators, and countless support staff. … to the Jazz team continuously working to deliver this important medicine patients. Inte

  38. Slide 38: Q&A

    Q&A Intended for U.S. investor audiences only.

  39. Slide 39: Glossary

    Glossary Acronym Definition Acronym Definition Acronym Definition 1H First half IHC Immunohistochemistry TEAE Treatment-emergent adverse event 1L First-line IQR Interquartile range TCHP Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab 2L Second-line IRR Infusion-related reaction TIS Tislelizumab

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