Slides
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August 25, 2026 ZIIHERA® (zanidatamab-hrii) Launch Webcast Innovating to Transform the Lives of Patients and Their Families Intended for U.S. investor audiences only.
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2 Transforming Lives. Redefining Possibilities. Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements related to: the company’s advancement of pipeline programs and the timing of development activities, regulatory activities, approvals, and submissions related thereto; the potential for a near-term commercial launch of Ziihera in 1L HER2+ GEA in the U.S.; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof; the company’s development, regulatory and commercialization strategy; the company’s expectations with respect to its regulatory submissions; the company’s expectations with respect to its products and product candidates and the potential of the company’s products and product candidates and the potential regulatory path related thereto, including Ziihera's potential to become the HER2-targeted therapy of choice in 1L HER2+ GEA, regardless of PD-L1 status and the potential of establishing Ziihera as the new standard of care in treating HER2+ GEA, regardless of PD-L1 status; the potential successful future development, manufacturing, regulatory and commercialization activities; the company’s expectations with respect to its collaborations with third parties; the company’s ability to realize the commercial potential of its products; the company’s net product sales and goals for net product sales from new and acquired products; the company’s views and expectations relating to its patent portfolio, including with respect to expected patent protection, as well as expectations with respect to exclusivity; the company’s clinical trials confirming clinical benefit or enabling regulatory submissions; and other statements that are not historical facts. These forward-looking statements are based on the company’s current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: effectively launching and commercializing the company’s other products and product candidates, including Ziihera in 1L HER2+ GEA; the successful completion of development and regulatory activities with respect to the company’s product candidates; obtaining and maintaining adequate coverage and reimbursement for the company’s products; the time-consuming and uncertain regulatory approval process, including the risk that the company’s current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the company’s business operations and financial results; protecting and enhancing the company’s intellectual property rights and the company’s commercial success being dependent upon the company obtaining, maintaining and defending intellectual property protection and exclusivity for its products and product candidates; delays or problems in the supply or manufacture of the company’s products and product candidates, including due to geopolitical tensions and military conflicts; complying with applicable U.S. and non-U.S. regulatory requirements, including those governing the research, development, manufacturing and distribution of controlled substances; government investigations, legal proceedings and other actions; identifying and consummating corporate development transactions, financing these transactions and successfully integrating acquired products, product candidates and businesses; the company’s ability to realize the anticipated benefits of its collaborations and license agreements with third parties; the sufficiency of the company’s cash flows and capital resources; and other risks and uncertainties affecting the company, including those described from time to time under the caption “Risk Factors” and elsewhere in the company’s Securities and Exchange Commission filings and reports, including the company's Annual Report on Form 10-K for the year ended December 31, 2025 and future filings and reports by the company. Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Intended for U.S. investor audiences only.
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3 Agenda Introduction and Overview John Bluth Head of Investor Relations Ziihera: Beyond GEA Samantha Pearce Chief Commercial Officer Ziihera: Clinical Overview Robert Iannone, M.D., M.S.C.E. Chief Medical Officer and Global Head of Research and Development Ziihera: GEA Commercial Overview Chumi Khurana Oncology Franchise Head 3 Intended for U.S. investor audiences only.
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Introduction and Overview John Bluth Head of Investor Relations 4 Intended for U.S. investor audiences only.
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5 Now Commercially Available Ziihera full prescribing information contains a Boxed Warning for diarrhea and embryo-fetal toxicity. Additional safety information is provided later in this presentation and full prescribing information is available at https://ziihera.com/. Intended for U.S. investor audiences only. • First and only bispecific HER2-targeted antibody combined with a PD-1 inhibitor and chemotherapy approved for all HER2+ advanced GEA patients, regardless of PD-L1 status, establishing a new standard of care in first-line treatment • Ziihera combinations exceeded two years of median OS, representing the longest survival outcomes ever reported in this setting • PFS and OS benefits were consistent in patients with PD-L1-positive and PD-L1-negative disease
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Robert Iannone, M.D., M.S.C.E. Executive Vice President, Global Head of Research and Development and Chief Medical Officer Intended for U.S. investor audiences only. 6 Clinical Overview
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7 Ziihera U.S. Label Indications and Usage Indicated for GEA: • In combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as first-line treatment of adult patients with HER2-positive (IHC 3+ and IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test • In combination with fluoropyrimidine- and platinum-containing chemotherapy, as first-line treatment of adult patients with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test Dosage and Administration • <70 kg: ZIIHERA 1,800 mg intravenously every 3 weeks or 1,200 mg every 2 weeks infusion in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr • ≥70 kg: ZIIHERA 2,400 mg intravenously every 3 weeks or 1,600 mg every 2 weeks in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr Dosage Forms and Strengths • For injection: 300 mg lyophilized powder in a single-dose vial Contraindications • None Highlights of prescribing information Intended for U.S. investor audiences only.
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8 Ziihera plus Tislelizumab and Chemo Show Superior Overall Survival Data summary from USPI comparing Arm C and Arm A in patients with HER2 IHC 3+ and IHC 2+/ISH+ Efficacy Parameter Arm C Ziihera with chemotherapy and tislelizumab N=302 Arm A Trastuzumab with chemotherapy N=308 Overall Survival Median, months (95% CI) 26.4 (21.5, 30.3) 19.2 (16.8, 21.8) P-Value 0.0043 Progression-free survival Median, months (95% CI) 12.4 (9.8, 18.5) 8.1 (7.0, 8.9) P-Value < 0.0001 Objective Response Rate ORR (95% CI) 67% (61, 72) 63% (57, 68) Complete Response Rate 20% 12% Partial Response Rate 47% 50% Duration of Response N=202 N=193 Median in months (95% CI) 18.9 (12.1, 37.7) 8.3 (6.8, 10.1) Intended for U.S. investor audiences only. a Estimates per Kaplan-Meier method; CIs based on Brookmeyer and Crowley method with log-log transformation. b Hazard ratio and 95% CIs were calculated in comparison with treatment arm Trastuzumab + Chemotherapy stratified by geographic region, HER2 status, and ECOG performance status. c The p-values were calculated by stratified log-rank test. d Two-sided 95% exact confidence interval using the Clopper-Pearson method. CI=confidence interval
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9 Ziihera and Chemo Show Superior Overall Survival Data Summary from USPI comparing Arm B and Arm A in patients with HER2 IHC 3+ Intended for U.S. investor audiences only. Efficacy Parameter Arm B Ziihera with chemotherapy N=251 Arm A Trastuzumab with chemotherapy N=255 Overall Survival Median, months (95% CI) 25.5 (21.9, 30.3) 19.8 (16.2, 22.8) Hazard Ratio (95% CI) 0.74 (0.58, 0.95) Progression-free survival Median, months (95% CI) 14.2 (11.7, 16.7) 7.6 (6.9, 8.5) Hazard Ratio (95% CI) 0.55 (0.43, 0.69) Objective Response Rate ORR (95% CI) 71% (64, 76) 64% (57, 69) Complete Response Rate 19% 12% Partial Response Rate 51% 52% Duration of Response N=177 N=162 Median in months (95% CI) 16.9 (12.8, 25.3) 8.1 (6.5, 9.8) a Estimates per Kaplan-Meier method; CIs based on Brookmeyer and Crowley method with log-log transformation. b Hazard ratio and 95% CIs were calculated in comparison with treatment arm Trastuzumab + Chemotherapy stratified by geographic region, HER2 status, and ECOG performance status. c Two-sided 95% exact confidence interval using the Clopper-Pearson method. *Overall survival data was immature at the time of this analysis.
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10 Warnings and Precautions Boxed Warning for Diarrhea and Embryo-Fetal Toxicity • ZIIHERA, in combination with fluoropyrimidine- and platinum-containing chemotherapy with or without tislelizumab-jsgr, can cause severe diarrhea, including life threatening, and fatal cases. Use antidiarrheal prophylaxis during the first cycle when ZIIHERA is given in combination with these drugs. Manage with antidiarrheals and supportive measures as clinically indicated. Interrupt, reduce the dose or discontinue ZIIHERA based on severity. (2.4, 5.1, 8.5) • Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. (5.2) Warnings and Precautions • Left Ventricular Dysfunction: Assess left ventricular ejection fraction (LVEF) prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold or permanently discontinue ZIIHERA based on severity. (2.4, 5.3) • Infusion-Related Reactions (IRRs): Premedicate before each infusion of ZIIHERA. Interrupt the infusion, decrease the infusion rate, and/or permanently discontinue ZIIHERA based on severity. (2.2, 2.4, 5.4) Adverse Reactions • Most common adverse reactions (≥ 20%) with ZIIHERA in combination with chemotherapy and tislelizumab-jsgr were diarrhea, nausea, decreased appetite, hypokalemia, vomiting, fatigue, peripheral neuropathy, rash and IRR. (6.1) • Most common adverse reactions (≥ 20%) with ZIIHERA in combination with chemotherapy were diarrhea, nausea, vomiting, peripheral neuropathy, decreased appetite, fatigue, hypokalemia, IRR and rash. (6.1) Use in Specific Populations • Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of ZIIHERA. (8.3) Intended for U.S. investor audiences only. Ziihera U.S. Label Highlights of prescribing information
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11 Zanidatamab’s Biparatopic Binding Drives Unique MOA and Clinical Activity ADCC / ADCP = antibody-dependent cellular cytotoxicity / phagocytosis; C1q: complement component 1q protein complex; EGFR = epidermal growth factor receptor; Fc receptor = fragment crystallizable receptor; HER2 / 3 = human epidermal growth facto receptor 2 / 3; MOA = mechanism of action; NK cell = natural killer cell. Source: Weisser et al. Nat Commun. 2023;14(1):1394. Zanidatamab simultaneously binds two non-overlapping extracellular domains of HER2 (biparatopic binding) Unique geometry and binding properties result in multiple mechanisms of action 11 Intended for U.S. investor audiences only.
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GEA Commercial Overview Chumi Khurana Senior Vice President, Oncology Franchise Head Intended for U.S. investor audiences only. 12
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13 Unmet Need Remains In Gastroesophageal Adenocarcinoma (GEA) 1 1.American Cancer Society. About Stomach Cancer. https://www.cancer.org/content/dam/CRC/PDF/Public/8838.00.pdf (accessed Feb 5, 2026); 2. American Cancer Society. Esophageal Cancer. https://www.cancer.org/content/dam/CRC/PDF/Public/9751.00.pdf (accessed Feb 5, 2026); 3. National Cancer Institute. Cancer Stat Facts: Esophageal Cancer. https://seer.cancer.gov/statfacts/html/esoph.html (accessed Feb 5, 2026); 4. National Cancer Institute. Cancer Stat Facts: Stomach Cancer. https://seer.cancer.gov/statfacts/html/stomach.html (accessed Feb 5, 2026); 5. Van Cutsem E, et al. Gastric Cancer. 2015;18:476–484; 6. Abrahao-Machado LF, Scapulatempo-Neto C. World J Gastroenterol. 2016;22:4619–4625; 7. Bartley AN, et al. Arch Pathol Lab Med. 2016;140:1345–1363. 8. American Cancer Society. Stomach Cancer Early Detection, Diagnosis, and Staging. https://www.cancer.org/cancer/types/stomach-cancer/detection-diagnosis-staging.html (accessed Aug 20, 2026). ANATOMIC LOCATION OF GEA1–2 DISEASE OVERVIEW1-8 Symptoms ~8K HER2+ GEA patient population <10% Five-year survival rate in mGEA 14-20 months Median overall survival ~3-4K Ziihera treatable patient population GEJ Antrum Stomach Body Esophagus Pylorus Intended for U.S. investor audiences only.
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14 1FDA Approval received on XXXX; 2REFERENCE; 3REFERENCE. New Standard1 of Care in 1L HER2+ GEA Establish Ziihera as the HER2-targeted agent of choice for 1L HER2+ mGEA patients, regardless of PD-L1 statusGOAL: Ziihera = New Standard of Care for 1L HER2+ mGEA Regardless of PD-L1 Status PD-L1+ (CPS ≥1) PD-L1- (CPS <1) Trastuzumab + pembrolizumab + chemo (KN-811 regimen) Trastuzumab + chemo (TOGA regimen) Advanced HER2+ GEA PD-L1+ (CPS ≥1) PD-L1- (CPS <1) ZIIHERA + tislelizumab + chemo1 OR ZIIHERA + chemo2 Advanced HER2+ GEA PRIOR STANDARD OF CARE NEW STANDARD OF CARE Intended for U.S. investor audiences only. 1In combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab, as first-line treatment of adult patients with HER2-positive (IHC 3+ and IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma; 2In combination with fluoropyrimidine- and platinum-containing chemotherapy, as first-line treatment of adult patients with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
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15 Confidential - For Internal Use OnlyIntended for U.S. investor audiences only. 1. Clinical Education & Differentiation Establishing the new Standard of Care: Ziihera + tislelizumab as foundational backbone for 1L HER2+ mGEA, independent of PD-L1 status 2. Accelerated Market Access Leveraging immediate reimbursement: Utilize established, permanent J-code eliminating barriers to launch and driving rapid formulary adoption 3. Commercial & Field Execution Day-one mobilization: cross-functional teams prepared to launch immediately upon FDA approval; capitalize on significant account overlap with Ziihera in BTC and Zepzelca in SCLC 4. Seamless Patient Experience Frictionless onboarding: Activating comprehensive JazzCares support services; ensure zero barriers to patient access Ready for GEA Launch Goal: Establish Ziihera as HER2-Targeted Agent of Choice in 1L HER2+ GEA
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16 Confidential - For Internal Use Only Strategic Investment in Educating Nurses & Patients Will Accelerate GEA Adoption and Adherence, Helping Patients Start and Stay on Ziihera CRM: customer relationship management; HCP: healthcare provider Build HCP Confidence to Prescribe and Persist Improve Early Patient Experience Support Long-Term Adherence Patient Education Resources Nurse Education Resources • Dosing & Administration Guide • Diarrhea Management Guide • Nurse Speakers Bureau • Patient Starter Kit – containing loperamide samples • Patient Brochure • Patient CRM Emails Clinical Educator Team • NEW for GEA Launch: Oncology Certified Nurses providing peer to peer proactive education Objectives Intended for U.S. investor audiences only.
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Samantha Pearce Executive Vice President, Chief Commercial Officer 17 Intended for U.S. investor audiences only. Beyond GEA
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18 Robust Ongoing Zanidatamab Development Program PHASE 1 PHASE 2 PHASE 3 RECENT / UPCOMING MILESTONES Now Approved 1L BTC confirmatory trial Anticipate top-line data late 2027 / early 2028 Pivotal trial supporting potential pan-tumor indication Early breast cancer trial Collaborative I-SPY2 trial for early breast cancer Collaborative trial with MD Anderson Cancer Center for early breast cancer Collaborative trial with Canadian Cancer Trials Group for GEA Collaborative ZANGEA trial for 1L GEA in combination with pembrolizumab Platform trial assessing potential of organ sparing for zanidatamab combinations Collaborative Pre I-SPY trial for breast cancer in combination with tucatinib Collaborative trial with Boehringer Ingelheim’s novel HER2 TKI Collaborative trial with Iambic’s brain-penetrant HER2 small-molecule TKI 1L BTC (HERIZON-BTC-302) Neoadjuvant treatment of locally advanced BC (I-SPY2) 1L GEA (HERIZON-GEA-01) Metastatic breast cancer (mBC) patients post T-DXd (EmpowHER-BC-303) Pivotal trial for HER2+ solid tumors (DiscovHER-Pan-206) Neoadjuvant and adjuvant BC (EmpowHER-BC-208) Phase 1/1b I-SPY in breast cancer Open-label trial in early-stage, low-risk, HER2+ breast cancer Paclitaxel and ramucirumab combination in HER2+ advanced GEA Pembrolizumab and chemotherapy combination in HER2+ GEA Zongertinib combination IAM1363 combination Neoadjuvant /adjuvant HER2+ GEA (AACR-ADOPT-GEA) Intended for U.S. investor audiences only.
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19 Zanidatamab: Updated Peak Sales Opportunity of $3-$5B Drivers of Peak Sales Increase: • Approvals in BTC and GEA, derisked investments in existing studies • Additional registrational trials planned in CRC, NSCLC, and early gas tric cancer • Additional registrational opportunities in mBC, early breast cancer and with novel combinations, including TKIs Intended for U.S. investor audiences only. Biliary Tract Cancer Breast Cancer Gastroesophageal Adenocarcinoma Broad Potential • Ongoing registrational Pan Tumor trial (DiscovHER-Pan-206) • Colorectal cancer • Non-small cell lung cancer • Combinations with novel agents Other HER2- Expressing Cancers $3 – $5 billion peak sales opportunity New Standard of Care in 2L BTC Phase 3 in 1L BTC (HERIZON-BTC-302) New Standard of Care in 1L HER2+ GEA Opportunity in early GEA Ongoing Phase 3 trial in mBC (EmpowHER-BC-303) Opportunity in early BC (EmpowHER-BC-208) Opportunity with novel combinations in BC, including TKI combinations
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Closing Remarks 20 Intended for U.S. investor audiences only.
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21 Ziihera Poised for Significant Growth Intended for U.S. investor audiences only. 2026 2027 and Beyond • Initiate CRC and NSCLC Phase 3 trials • Continue to broaden development program in Breast Cancer • Expect EmpowHER-BC-303 trial top-line readout late 2027 / early 2028 • Continued investment in additional registrational opportunities • GEA launched on 25 August 2026 • Product available for supply to treatment centers/physicians • Focus on establishing Ziihera as treatment of choice in HER2+ 1L GEA Commercial Launch Robust Development Program $3 – $5 billion peak sales opportunity
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Q&A 22 Intended for U.S. investor audiences only.
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23 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 and BeOne teams continuously working to deliver this important medicine to patients. Intended for U.S. investor audiences only. Intended for U.S. investor audiences only.