Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — 37th Annual J.P. Morgan Healthcare Conference (January 2019)
28 slides from Halozyme Therapeutics's conference presentation, Jan 9, 2019
Slide 1: Building a Premier Oncology Biotech
37th Annual J.P. Morgan Healthcare Conference Building a Premier Oncology Biotech Dr. Helen Torley, President and CEO January 9, 2019
Slide 2: Forward-Looking Statements
Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of such statements include possible activity, benefits and attr
Slide 3: Two Engines for Growth
Two Engines for Growth ENHANZE® PEGPH20 Proven ‘IV to Sub Q’ Late Stage Targeted Partnering Platform Oncology Asset Phase 3 Data Accelerating Partner Readout Currently Investment for Approvals Projected in 2H 2019 High Potential: Potential ~$1B Global ~$1B Annual Royalty Pancreas Indication Revenue
Slide 4: Significant Value Creating Events in 2018
Significant Value Creating Events in 2018 ENHANZE® PEGPH20 • Daratumumab SC trials targeting ~2,000 • HALO-301 enrollment completed multiple myeloma patients now initiated • Agreement reached with FDA on • De-risking progress to Phase III primary endpoint: Overall Survival – Darzalex® – Perjeta ® /H
Slide 5: ENHANZE
ENHANZE® 4
Slide 6: ENHANZE Offers Four Potential Paths for Differentiation and Value Creation
ENHANZE® Offers Four Potential Paths for Differentiation and Value Creation for Partners Reduced Treatment Burden 1 and Healthcare Costs Darzalex® ALXN 1210 2 Potential for Competitive Differentiation BMS I/O Portfolio 3 New Intellectual Property and Exclusivity Darzalex® Changing U.S. Reimbursement
Slide 7: ENHANZE High-Growth Business
ENHANZE ® High-Growth Business 8 Agreements signed to date: Bristol-Myers Squibb Roche (Genentech), Baxalta, Agreement Terms Pfizer, Janssen, Eli Lilly, Abbvie Number of 11 BMS and Alexion Targets Upfront $105M Milestones/ 3 Approved Products $160M Target 8 Targets in development today Royalties Mid
Slide 8: Near Term Catalysts: Potential Blockbuster Programs in Phase III in 2019
Near Term Catalysts: Project 3 Potential Blockbuster Programs in Phase III in 2019 2017 2018 2019 6 Products 11 Products 15 Products(1) 3 1 2 3 3 3 2 6 9 Approved and Commercialized Phase III 3 Commercialized Products Phase I 3 Products in Phase III 1 Projected by year-end as of January 9, 2019 7
Slide 9: Three Products Successfully Commercialized in Global Markets
Three Products Successfully Commercialized in Global Markets US ROW SC Formulation of Herceptin® FDA Action March 2019 8
Slide 10: ENHANZE Development Pipeline
ENHANZE® Development Pipeline Partner Product/Target Janssen / Darzalex® Phase III in Undisclosed Undisclosed 2019 Completing Ongoing Initiating BMS CD-73 OPDIVO® ALXN1210 Phase I in 2019 Undisclosed Undisclosed Undisclosed PLUS 4 Potential New Phase I Starts in 2019 9
Slide 11: Daratumumab IV: Blockbuster Multiple Myeloma Treatment
Daratumumab IV: Blockbuster Multiple Myeloma Treatment Early Launch Data Compares Analyst Estimates for Darzalex® Favorably with Other Multiple Myeloma Drug Launches ($ Millions) ($ Millions) Darzalex® 8000 2000 Empliciti® 7000 Kyprolis® 6000 1500 Ninlaro® Pomalyst® 5000 Revlimid® 4000 1000 3000 200
Slide 12: Daratumumab SC: Potential Regulatory Submissions in 2H 2019
Daratumumab SC: Potential Regulatory Submissions in 2H 2019 Timeline • Janssen anticipates filing regulatory submissions in H2 2019(1) Potential Benefits of Subcutaneous Formulation(2) • Faster infusion time (3-5 minutes)(3) • Well tolerated with fewer infusion related reactions (IRRs) than with IV(
Slide 13: Perjeta/Herceptin Fixed Dose Combination with ENHANZE: Potential Regulatory Submissions 2020
Perjeta®/Herceptin® Fixed Dose Combination with ENHANZE®: Potential Regulatory Submissions 2020 Potential Opportunity ® • PERJETA indicated for use Value proposition of Perjeta®/Herceptin® with Herceptin and Fixed Dose SC with ENHANZE (3) chemotherapy for adjuvant treatment of patients with 3 HER2+
Slide 14: Increasing Commercialization Activities to Support Expected ENHANZE Launches
Increasing Commercialization Activities to Support Expected ENHANZE® Launches Facilitating Rapid Global Commercialization by Partners • PH20 API: expect to deliver 1.8 Million doses(1) in response to partner orders in 2019 • Highest demand in our history • Support regulatory submissions in ~50 count
Slide 15: ENHANZE: ~$1B Royalty Revenue Potential in 2027
ENHANZE®: ~$1B Royalty Revenue Potential in 2027 2019-2021 Potential Cumulative ~$1 Billion Milestones = $225M-$300M All other partner products Royalties derived from products in phase 3 (2019) Herceptin, Rituximab, HyQvia 2018 2027 Projection based on approved products and assumes global approval a
Slide 16: ENHANZE: Royalties Already Exceed ENHANZE-only Operating Expenses
ENHANZE®: Royalties Already Exceed ENHANZE-only Operating Expenses 2019-2021 Potential Cumulative ~$1 Billion Milestones = $225M-$300M All other partner products Royalties derived from products in phase 3 (2019) ENHANZE-only Operating Expense Herceptin, Rituximab, HyQvia 2018 2027 Projection based o
Slide 17: Accelerating ENHANZE Growth
Accelerating ENHANZE ® Growth Daratumumab Potential Approval 12 Targets in SC Regulatory for Herceptin BLA Development Submissions in 2H Existing in March 2019 in 2019 Partnerships 2019 Potential in Oncology, Pool of Potential New Rare Diseases, Blood Partners and Targets Disorders, Immunology, New
Slide 18: PEGPH20
PEGPH20 17
Slide 19: Tumor HA Overexpression Associated with Shorter Survival in Pancreas Cancer
Tumor HA Overexpression Associated with Shorter Survival in Pancreas Cancer Retrospective Evaluation of Pancreatic Cancer Survival in ~50 Patients(1) HA-Low Median Survival: 24.3 months HA-High Median Survival: 9.3 months H.R. 2.6 p=0.037 1 Whatcott et al: Clin Cancer Res 2015, 21:3561-3568. HA stai
Slide 20: PEGPH20 Targets Hyaluronan (HA) in the Tumor Microenvironment
PEGPH20 Targets Hyaluronan (HA) in the Tumor Microenvironment In HA-High Tumor Animal Models, Removal of HA by PEGPH20 Demonstrated to: Decrease Decompress Increase Increase Increase intratumoral vasculature perfusion access for access for pressure therapeutics immune cells PEGPH20 19
Slide 21: Proprietary Test Developed in Phase II to Identify HA-High Patients
Proprietary Test Developed in Phase II to Identify HA- High Patients for Phase III • Partnered with Ventana for Analysis of OS in HA-High, Stage II HALO 202(1) Companion Diagnostic • Phase II Study HALO 202 key to develop Companion Diagnostic • 279 1L metastatic PDA • PEGPH20 plus Abraxane® and Gemc
Slide 22: HALO-301: Enrollment Complete with Approximately 500 Patients
Pancreas Cancer HALO-301: Enrollment Complete with Approximately 500 Patients Global Phase 3 Trial Now Fully Enrolled: ~500 Patients PEGPH20 + ABRAXANE® 1L Metastatic + gemcitabine (PAG) PDA Primary Endpoint: High-HA • Overall Survival (OS) patients ABRAXANE® + gemcitabine N=~500 (AG) + placebo Proj
Slide 23: Final Analysis Plan for HALO-301: Single Primary Endpoint of Overall Survival
Final Analysis Plan for HALO-301: Single Primary Endpoint of Overall Survival • Fixed sample size with target number of OS events: 330 • Mature dataset supporting best test of PEGPH20 – All patient follow up of at least 8.5 months – <10% patients less than 13 months • Well powered trial – 93% power
Slide 24: ~$1B Potential Opportunity in Pancreas Cancer
~$1B Potential Opportunity in Pancreas Cancer 65,000 Annual Diagnosed Metastatic Pancreatic Ductal Adenocarcinoma (PDA) U.S. and EU 5(1) ~$1B ~$1B Potential Global Sales Opportunity by 2027 in HA-High 25,000 Metastatic PDA(3) Estimated Number of HA-High Patients 35–40% of Population(2) 1 SEER 18 200
Slide 25: Ongoing Studies Evaluating Pan-tumor Potential of PEGPH20
Ongoing Studies Evaluating Pan-tumor Potential of PEGPH20 Tumor Stage Status Pancreas Cancer, Gastric Cancer Gall Bladder Cancer, Cholangiocarcinoma 24
Slide 26: 2019 Financial Guidance
2019 Financial Guidance 2018 Guidance 2019 Guidance Drivers (as of 11/5/18) • YoY royalty growth projected flat Net • API orders increasing to support ENHANZE commercial $150M to $160M $175M to $185M Revenue partners and launch readiness for Darzalex® • Does not include new ENHANZE deals Operating E
Slide 27: Outlook
Outlook • Growing ENHANZE momentum – ~$1 billion in annual royalty revenue potential by 2027 – Multiple near-term catalysts in a high margin business • Each pillar offers strong potential upside – ENHANZE: New deals plus up to $1 billion in lifetime milestones – PEGPH20: ~$1 billion global sales opp
Slide 28: Building a Premier Oncology Biotech
37th Annual J.P. Morgan Healthcare Conference Building a Premier Oncology Biotech Dr. Helen Torley, President and CEO January 9, 2019
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