Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — J.P. Morgan 29th Annual Healthcare Conference 2011
35 slides from Halozyme Therapeutics's conference presentation, Jan 10, 2011
Slide 1: J.P. Morgan 29th Annual Healthcare Conference
Gregory I. Frost, Ph.D. President and CEO J.P. Morgan 29th Annual Healthcare Conference January 12, 2011
Slide 2: Safe Harbor
Safe Harbor 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. These forward-looking statements and all references to financial estimates are based up
Slide 3: Halozyme Profile and Investment Highlights
Halozyme Profile and Investment Highlights An Innovative Enzyme Platform A capital efficient biopharmaceutical company developing and commercializing recombinant human enzymes that transiently modify tissue under the skin to facilitate injection of other therapies (biologics, peptides, small molecul
Slide 4: Updates January 2011
Updates ^ January 2011 Completed enrollment of two insulin analog-PH20 TID studies 110 type 1 and 110 type 2 patients in 24-week crossover study Data available internally 3Q2011 Reacquisition of Hylenex (stand alone 150 U dose rHuPH20) from Baxter Initial product reintroduction planned through a tra
Slide 5: Halozyme's Structure Enables Focus on Core Capabilities
Halozyme's Structure Enables Focus On Core Capabilities in a Capital Efficient Manner BD & Marketing Quality Assurance Research and Preclinical Clinical Development Product Development Manufacturing Regulatory Affairs contracted contracted Finance J.P. Morgan 29th Healthcare Conference, 2011
Slide 6: Core Activities in 2011 Support the Platform
Core Activities in 2011 Support the Platform Recombinant enzyme manufacturing supports partnerships and pipeline (Roche, Baxter) + (Ultrafast Insulin, PEGPH20, Hylenex) Two cGMP bulk rHuPH20 manufacturing sites established for multi-kg capacity Validation campaign at 300L scale complete 2Q2011 Valid
Slide 7: Halozyme's Core Technology: Targets Hyaluronan in Matrix
7 Halozyme's Core Technology: Targets Hyaluronan (HA) in "Matrix" matrix create resistance to bulk fluid flow rHuPH20 decreases local resistance to injection of other molecules allowing exposure to capillaries and lymphatics Halozyme's Core Technology: Targets Hyaluronan (HA) in "Matrix" J.P. Morgan
Slide 8: Pharmacokinetic Implications for Subcutaneous Peptides and Drugs
Time Plasma Levels Higher CMAX ^ Higher peak from same dose More Rapid TMAX ^ Fast In/ Fast Out ^CMAX & ^TMAX SC Plus rHuPH20 Standard SC PK Profile CMAX Pharmacokinetic (PK) Implications for Subcutaneous (SC) Peptides and Drugs J.P. Morgan 29th Healthcare Conference, 2011
Slide 9: Pharmacokinetic and Dosing Implications for Antibodies and Other Biologics
Time (hours to days) Plasma Levels IV Infusion (approved dose and frequency) SC with rHuPH20 SC alone No volume restrictions ^ Capture best dosing frequency Higher Cmax ^ Closer to IV than SC Higher BA ^ Similar to IV for clinical bridging Pharmacokinetic and Dosing Implications for Antibodies and O
Slide 10: Halozyme Product Pipeline
Halozyme Product Pipeline J.P. Morgan 29th Healthcare Conference, 2011
Slide 11: Alliances Drive Significant Value
Alliances Drive Significant Value ~ $108 million of alliance related cash received to date Enhanze technology with Roche ^ up to 8 biologic targets, 5 currently exclusive Alliance worth up to $377M ($20M up-front; $111M milestones for first 3 exclusive targets; $235M up-front & milestones for 5 addi
Slide 12: Herceptin SC and MabThera SC Phase Updates
Herceptin SC Phase 3 Enrollment Complete Phase 3, N=595, compares SC to IV, Herceptin dosing every three weeks for one year Two primary endpoints - PK (Herceptin serum concentrations, cycles 1-8) and efficacy (pathologic complete response, after cycle 8) Herceptin IV for 1 year is standard of care f
Slide 13: HyQ - SC Monthly Dosing at Single Site
GAMMAGARD Liquid - plasma derived immunoglobulin (IgG) indicated for primary immunodeficiency, approved for IV infusion $1B+ product franchise for Baxter, ~ $6B worldwide market Current SC IgG limited by low bioavailability (~70%) and small injection site volumes - requires weekly dosing with multip
Slide 14: Halozyme Reacquires Hylenex Distribution Rights from Baxter
Halozyme Reacquires Hylenex Distribution Rights from Baxter J.P. Morgan 29th Healthcare Conference, 2011 HyQ relationship with Baxter Bioscience unchanged Hylenex indicated for the dispersion and absorption of other injected drugs; for subcutaneous fluid hydration Composition of matter IP to recombi
Slide 15: Proprietary Product Development Candidates
Proprietary Product Development Candidates Ultrafast Insulin - Analog insulins formulated with rHuPH20 for diabetes PEGPH20 - PEGylated rHuPH20 targets HA expressing tumors HTI-501 - Novel Matrix remodeling enzyme targets collagen degradation for aesthetics J.P. Morgan 29th Healthcare Conference, 20
Slide 16: Halozyme's Ultrafast Injectable Insulin Program
Goal - To develop best-in-class rapid-acting insulin products that surpass current standards of care 8 clinical studies completed or ongoing with insulin products to optimize product configuration, safety profile and clinical attributes Proprietary insulin formulations of novel rHuPH20 permeation en
Slide 17: Ultrafast Insulin Could Have Best-in-Class Product Profile
Less mealtime hyperglycemia Accelerated insulin action (i.e., fast on) results in early glucose lowering effects and reduced post-meal hyperglycemia More patients meet treatment goals for postprandial hyperglycemia Ultrafast Insulin Could Have Best-in-Class Product Profile vs. Standard of Care Analo
Slide 18: Consistent Ultrafast PK Profile from Study to Study
Consistent Ultrafast PK Profile from Study to Study Proof of Concept Study in HV PH20 Dose Selection Study, Stage 4 Variability Study Comprehensive Analog Study Type 1 Meal Study Type 2 Meal Study J.P. Morgan 29th Healthcare Conference, 2011
Slide 19: Ultrafast Analog+PH20 Improves Glucose Control in T1DM and T2DM
Ultrafast Analog+PH20 Profile Improves Glucose Control in Both T1DM and T2DM Patients T1DM Meal Study (Identical dose with and without PH20) T2DM Meal Study (Dose optimized for each test article separately) T1DM Meal T2DM Meal % to Glycemic Goal (ADA) 36% More (91% v. 55%) 23% More (71% v. 48%) Hype
Slide 20: Two Ongoing Phase 2 Studies
Two Ongoing Phase 2 Studies - Analogs +- PH20, Part of Intensive TID Insulin Treatment Regime HALO-205, HALO-206, N=110 for each study, 3x/day, 12 weeks x-over Designed to demonstrate meaningful improvement of lispro-PH20 and/or aspart-PH20 vs. Humalog in patients with T1DM or T2DM Enrollment comple
Slide 21: Insulin Pump Market Represents an Additional Large Opportunity
0 Insulin Pump Market Represents an Additional Large Opportunity 54.0892193308612 89.5787139689681 45.9107806691502 10.4212860310433 MDI* Pump Patients with T2 Diabetes Patients with T2 Diabetes 90% 10% Patients with T1 Diabetes Patients with T1 Diabetes 54% 46% Primary Route of Prandial Insulin Del
Slide 22: Ultrafast Insulin Could Deliver Key Benefits to Pump Users
0 "Faster-In", "Faster-Out" Profile of Halozyme's Ultrafast Insulin Could Deliver Key Benefits to Pump Users Benefits of "Faster-in" Less waiting between delivery of bolus and meal consumption Accelerated insulin action and reduced post-meal hyperglycemia More patients meet treatment goals for postp
Slide 23: Continuous Subcutaneous Insulin Infusion (CSII) Study Design
Halozyme Continuous Subcutaneous Insulin Infusion (CSII) Study Design Primary Objective: Compare early insulin exposure (first 60 minutes following bolus infusion) for rapid-acting analog insulins (NovoLog, Apidra) with and without rHuPH20 during euglycemic glucose clamp procedures in patients with
Slide 24: PEGPH20 (PEGylated Recombinant Human PH20)
Kultti et al., J Biol Chem, 2006 PEGPH20 (PEGylated Recombinant Human PH20) Many tumors create a complex matrix environment 20-30% of all solid tumors produce a matrix comprising hyaluronan (HA) and proteoglycans Matrix-rich environment can generate resistance to therapies poor perfusion, high inter
Slide 25: PEGPH20 Addresses a Large, Unmet Medical Need
PEGPH20 Addresses a Large, Unmet Medical Need PEGPH20 therapy could provide broad access to multiple HA(+) tumor markets with large potential sales ($1B+) Cancers with the highest proportion of HA(+) patients include: Currently conducting two Phase 1 multicenter, open-label, escalating, repeat dose
Slide 26: Study 102, Patient - Esophageal Carcinoma
Study 102, Patient 2 - Esophageal Carcinoma Baseline DCE-MRI 72 hr follow-up DCE-MRI Pre-Rx 72h post-Rx Dynamic Contrast Enhancement (DCE)-MRI (PEGPH20 1.6 µg/kg IV twice weekly) Imaging changes in tumor support mechanism of action Increased perfusion of tumor vasculature 72 hrs Post-dose Pre-dose L
Slide 27: HTI-501 (conditionally active recombinant human cathepsin)
HTI-501 (conditionally active recombinant human cathepsin) A first-in-class injectable recombinant human enzyme shown preclinically to locally break down the collagen fibrils that can cause disfiguring scars, contractures and cellulite Disfiguring scars (keloids, hypertrophic scars) and aesthetic ap
Slide 28: Potential Milestones for 2011
Potential Milestones for 2011 Top line Phase 3 HyQ results by Baxter, 1H11 Filing of HyQ BLA by Baxter, 2011 Initiate randomized PEGPH20 Phase 2 clinical trial in pancreatic cancer, 2H11 Presentation of data from analog insulin pump studies with rHuPH20 3Q11 Initiate dosing of HTI-501 in ex-U.S. pro
Slide 29: Late Stage Programs Target Over $20 Billion in Product Opportunities
Halozyme's Late Stage Programs Target Over $20 Billion in Product Opportunities Roche's Herceptin SC in Phase 3 pivotal trial, $5.1B WW product, MabThera SC in Phase 1, $5.9B WW product Baxter BioScience's HyQ with rHuPH20 completed pivotal Phase 3, $6B WW market Interim manufacturing resolution in
Slide 30: Halozyme Therapeutics - Supplementary Slides
Halozyme Therapeutics - Supplementary Slides Investor Presentation J.P. Morgan 29th Healthcare Conference, 2011
Slide 31: Herceptin - For Treatment of HER2-Overexpressing Breast Cancer
Herceptin(r) - For Treatment of HER2-Overexpressing Breast Cancer Breast Cancer Most common cancer among women worldwide More than 1M new cases of breast cancer (BC) diagnosed annually worldwide 20-25% of women with breast cancer are HER2-positive Herceptin Humanized monoclonal antibody that targets
Slide 32: Herceptin Dosing
Herceptin dosing Approved Chemotherapy Regimens Schedule 1 - paclitaxel or docetaxel Schedule 2 - docetaxel/carboplatin Schedule 3 - anthracyclines such as doxorubicin and cyclophosphamide. Source: Herceptin U.S. package insert Chemotherapy dosing Herceptin use during adjuvant treatment Dosing sched
Slide 33: Herceptin SC - Phase 3 Clinical Trial Design
Herceptin SC - Phase 3 Clinical Trial Design Registration trial began Oct 2009, enrollment completed Dec 2010, N = 595, women with HER2-positive operable or locally advanced breast cancer, HANNAH Pre-operative treatment with 8 cycles of chemotherapy (docetaxel followed by 5-FU/epirubicin/cyclophosph
Slide 34: MabThera SC - Phase 1 Trial Underway
MabThera(r) SC - Phase 1 Trial Underway Phase 1 began 9/09, N=245 patients with follicular lymphoma, maintenance treatment after response to IV induction therapy Two stages, involves randomization to SC or IV, Stage 1 data presented at ASH, Dec 2010 Primary endpoint - PK trough concentration for SC
Slide 35: Herceptin and MabThera/Rituxan - A Large and Growing Market Opportunity
% Herceptin and MabThera/Rituxan - A Large and Growing ~$11 Billion Market Opportunity *2005-2009 year end exchange rates from oanda.com Source: Roche annual reports, 2005-2009 (CHART) ~54% of sales in EU/Int'l. in 2009 J.P. Morgan 29th Healthcare Conference, 2011
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