Jazz Pharmaceuticals Plc · NASDAQ:JAZZ
Jazz Pharmaceuticals — Merger or Acquisition (May 2016)
27 slides from Jazz Pharmaceuticals's merger presentation, May 31, 2016
Slide 1: Acquisition of Celator Pharmaceuticals
Acquisition of Celator Pharmaceuticals May 31, 2016 Exhibit 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements regarding Jazz Pharmaceuticals and Celator Pharmaceuticals, including, but not limited to, statements related to the anticipated consummation of the tender offer for Celator common stock and the timing and benefits ther
Slide 3: Additional Information and Where to Find It
Additional Information and Where to Find It The tender offer described in this communication (the “Offer”) has not yet commenced and this communication is neither an offer to purchase nor a solicitation of an offer to sell shares of Celator or other securities, nor is it a substitute for the tender
Slide 4: Background and Strategic Rationale
Background and Strategic Rationale
Slide 5: Celator Pharmaceuticals Background
Celator Pharmaceuticals Background History Founded in 1999 Clinical stage biopharmaceutical company that develops therapies to treat cancer Lead Molecule VYXEOS™ (CPX-351) VYXEOS is a nano-scale liposomal co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio Completed Phase
Slide 6: Celator Transaction is a Strong Strategic Fit: Differentiated Product Candidate
Celator Transaction is a Strong Strategic Fit Differentiated Product Candidate Addresses Unmet Medical Need in High-Risk1 (Secondary) AML Worldwide Product Opportunity Worldwide development and commercialization rights to VYXEOS Differentiated Molecule Phase 3 clinical data show statistically signif
Slide 7: Celator Transaction is a Strong Strategic Fit: Leverages Jazz Global Footprint
Celator Transaction is a Strong Strategic Fit Leverages Jazz Pharmaceuticals’ Global Footprint and Enhances Hem/Onc Portfolio FDA Breakthrough Therapy Designation and Expected Long-Lived Asset Commercial Synergies/ Targeted Prescriber Base Overlap of current Jazz Pharmaceuticals’ accounts in academi
Slide 8: U.S. Approved Treatment Options
U.S. Approved Treatment Options FDA Approvals in Selected Hematology/Oncology Indications May 1996 – May 2016 AML: a Disease with Few Approved Treatment Options Lymphoma Acute Lymphoblastic Leukemia Multiple Myeloma Chronic Lymphocyte Leukemia Chronic Myeloid Leukemia Acute Myeloid Leukemia US Appro
Slide 9: Celator Transaction and Expected Financial Impact
Celator Transaction and Expected Financial Impact Summary Offer Details Offer price of $30.25 per share in cash Total consideration of approximately $1.5 billion Plan to commence tender offer shortly Expect to close tender offer in 3Q16 Financing Plan to finance with cash on hand and our senior secu
Slide 10: Clinical Overview
@ Jazz Pharmaceuticals Clinical Overview ——
Slide 11: Significant Unmet Need: AML is the Most Common Acute Leukemia in Adults
Significant Unmet Need AML is the Most Common Type of Acute Leukemia in Adults AML constitutes the most common form of all leukemias in adults1 AML is generally a disease of older adults Median age of diagnosis of ~67 years2 High risk AML represents approximately 40% of AML patients across age group
Slide 12: Outcomes in Patients With High-Risk (Secondary) AML Decrease With Age
Source:. SEER. 2. Burnett A, et al. J Clin Oncol. 2011;29(5):487-494. 100 80 60 40 20 0 1 2 3 4 5 6 7 8 9 10 Time (years) Survival (%) Age, years < 50 50-64 65-74 ≥ 75 100 75 50 25 0 5 10 15 20 25 Survival Still Alive (%) Time From Entry (years) 53 43 35 29 23 15 5 Age ≥ 60 1970-79 1980-84 1985-89 1
Slide 13: VYXEOS Product Overview
VYXEOS Product Overview Celator Preparing for U.S. NDA Submission by the End of 3Q16 A nano-scale liposomal co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio Taken up preferentially by human leukemia cells, ensuring intracellular delivery of the optimal dose Hypothesized
Slide 14: CombiPlex: Maximizing Effect of Combined Drugs
CombiPlex: Maximizing Effect of Combined Drugs Source: Celator research
Slide 15: Summary of Pharmacologic Basis of VYXEOS
Summary of Pharmacologic Basis of VYXEOS VYXEOS liposomes deliver 5:1 molar ratio for > 24 hours VYXEOS accumulates and persists in the bone marrow Selective uptake of VYXEOS by leukemia blasts and intracellular drug release Mayer LD, Harasym TO, Ratiometric dosing of anticancer drug combinations: c
Slide 16: Phase 3 Study of CPX-351 vs Standard Induction in Older Patients
Phase 3 Study of CPX-351 vs Standard Induction in Older Patients with Newly Diagnosed High-Risk AML Primary Endpoint: Overall survival Secondary Endpoints: Leukemia clearance rate, response rate (CR + CRi), response/ remission duration, event-free survival (EFS), 60-day mortality Patients were allow
Slide 17: VYXEOS: Statistically Significant Improvement in Overall Survival
Overall survival based on ITT – Hazard Ratio = 0.69, p value = 0.005 60.7% relative improvement in median overall survival VYXEOS: Statistically Significant Improvement in Overall Survival A 31% Reduction in the Risk of Death
Slide 18: VYXEOS: Overall Survival Improvement at 12 and 24 Months
VYXEOS: Overall Survival Improvement at 12 and 24 Months
Slide 19: VYXEOS: Statistically Significant Improvement in Response
VYXEOS: Statistically Significant Improvement in Response More Patients Went on to Receive a SCT on the VYXEOS Arm SCT = stem cell transplant
Slide 20: VYXEOS: 60-Day Mortality vs 7+3 and Adverse Events
VYXEOS: 60-Day Mortality vs 7+3 Grade 3 or Higher Adverse Events Similar Between Treatment Arms No substantial difference in Grade 3 or higher hematologic and non-hematologic adverse events between VYXEOS and 7+3 In the intent-to-treat population, Grade 3 or higher, hematologic adverse events were s
Slide 21: Celator Pipeline: Potential to Develop CombiPlex in Additional Tumor Types
Celator Pipeline: Potential to Develop CombiPlex Technology in Additional Tumor Types Research Preclinical Phase 1 Phase 2 Phase 3 Regulatory CPX-351 Cytarabine: Daunorubicin U.S. NDA submission planned by the end of 3Q16 CPX-351* Investigator-Initiated Studies Pre-conditioning prior to Cord Blood H
Slide 22: Commercial Opportunity/Market Overview
Commercial Opportunity/Market Overview
Slide 23: AML Represents About 25% of Adult Leukemias in Western World
AML Represents About 25% of Adult Leukemias in Western World Estimate 65,000 AML Diagnosed Patients Are Accessible—Representing a Significant Potential Opportunity Source: SEER, Kantar Health, UN Department of Economic and Social Affairs, Decision Resources, Jazz Internal Analysis
Slide 24: AML Patients Eligible for Drug Treatment in the U.S.
AML Patients Eligible for Drug Treatment in the U.S. About 40% of AML Patients are High-Risk ~50% ~80% ~19.9K ~9.9K ~8K Eligible Drug Treated Patients (Excl clin trials) Sources: American Cancer Society (2015); SEER (National Cancer Institute);Medeiros et al , Big data analysis of treatment patterns
Slide 25: VYXEOS Reimbursement Landscape in AML
VYXEOS Reimbursement Landscape in AML Payer Mix Driven by Age Demographics, With a Sizeable Medicare Reimbursed Population Source: SEER, Internal Jazz Primary Research VYXEOS reimbursement and site of administration In-patient utilization reimbursed through Medicare DRG or commercial payer contracte
Slide 26: Commercial Planning
Commercial Planning Potential launch preparation Immediately leverage knowledge from existing products AML treaters are in many of the same accounts as ALL and transplant targets Able to apply best practices from the recent Defitelio launch Implement launch team Kick off development of brand campaig
Slide 27: Q&A
Q&A
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