Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Canaccord Cardiovascular, Diabetes & Obesity Conference 2010
38 slides from Halozyme Therapeutics's conference presentation, Dec 8, 2010
Slide 1: Halozyme Therapeutics: Matrix Therapies for Life
Halozyme Therapeutics Matrix Therapies for Life Doug Muchmore, M.D., VP, Endocrinology Clinical Development Robert H. Uhl, Senior Director, Investor Relations Canaccord Cardiovascular, Diabetes & Obesity Conference San Francisco, December 8, 2010
Slide 2: Safe Harbor
Safe Harbor The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. All statements made in this presentation that are not statements of historical fact constitute forward-looking statements. The matters referred to in forward-looking statements c
Slide 3: Halozyme Investment Highlights
Halozyme Investment Highlights Strong technology foundation and pipeline of proprietary and partnered programs with significant revenue potential Core technology is rHuPH20 hyaluronidase enzyme ("PH20"): FDA approved, with strong safety profile and IP protection Phase 3 programs - HyQ SC with Baxter
Slide 4: PH20 Core Technology: Targets Hyaluronan (HA) in Matrix
4 PH20 Core Technology: Targets Hyaluronan (HA) in "Matrix"
Slide 5: Halozyme Pipeline
Halozyme Pipeline Ultrafast Insulin Insulin-PH20 Endocrinology Diabetes —_— ‘Analog-PH20 Endocrinology Diabetes D> PEGPH2O Oncology Sodus a! HTso1 Dermatology Aesthetic medicine other Sm Partnered Product Candidates Roche pt 8 potent tgs) Herceptin” SC ‘Oncology Breastcancer Mabtherd' SC Oncology No
Slide 6: Existing Alliances Drive Significant Value
Existing 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 f
Slide 7: Herceptin SC and MabThera SC Roche programs
Herceptin SC 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 for treatment of HER2-overexp
Slide 8: HyQ (immunoglobulin) - SC Monthly Dosing at Single Site
GAMMAGARD Liquid - plasma derived immune globulin (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 - results in weekly dosing with mul
Slide 9: HYLENEX - For Use in Pediatric Hydration
HYLENEX - For Use in Pediatric Hydration Voluntary product recall announced May 2010 to ensure patient safety; no medical or adverse events reported in conjunction with the manufacturing issues Manufacturing issue unique to HYLENEX, does not impact any other Halozyme development programs Halozyme ha
Slide 10: Proprietary Product Candidates Target the Matrix
Proprietary Product Candidates Target the Matrix Ultrafast Insulin - PH20 with regular and mealtime analog insulins for diabetes PEGPH20 - Pegylated PH20 targets HA expressing tumors HTI-501 - Novel Matrix remodeling enzyme targets collagen degradation 10
Slide 11: Halozyme's Ultrafast Insulin Program
Goal - To develop best-in-class rapid-acting insulin products that surpass current standards of care Proprietary insulin formulations of novel PH20 permeation enhancing excipient with Rapid-acting analog insulin (Humalog(r), NovoLog(r), Apidra(r)) ? "Analog-PH20" Short-acting regular human insulin (
Slide 12: Goal of Intensive Insulin Therapy: Mimic Normal Physiologic Insulin Response
Goal of Intensive Insulin Therapy: Mimic Normal Physiologic Insulin Response Source: modified from Am Fam Physician. 2004 Aug 1;70(3):489-500 Role of rapid-acting insulin is to mimic normal insulin release response to meal Long-acting (basal) Optimum rapid-acting (prandial) profile 12
Slide 13: Current Mealtime Insulin Alternatives Are Too Slow
Goal of Intensive Insulin Therapy: Mimic Normal Physiologic Insulin Response Source: modified from Am Fam Physician. 2004 Aug 1;70(3):489-500 Role of rapid-acting insulin is to mimic normal insulin release response to meal Long-acting (basal) Current mealtime insulin alternatives are too slow to acc
Slide 14: Failure to Mimic Physiologic Insulin Leads to Unmet Needs
Failure to Mimic Physiologic Insulin Leads to Unmet Needs and Risk of Adverse Outcomes 1 IMS Data, 2008 GFK Roper Patient Survey, N = 2,000 (projectable) Rapid analogs too slow to prevent high blood glucose after a meal Majority of patients report failure to meet ACE target Many patients feel bad wh
Slide 15: $3.8B Prandial Analog Insulin Market Growing Rapidly
1 Source: IMS 2010 EU =France, Germany, Italy, Spain, UK. JP = Japan Sales total includes Humalog, Humulin R, NovoLog, Novolin R, Apidra and equivalent local brands. Excludes mixes and long-acting versions of Humulin and Novolin. Despite Shortcomings, $3.8B Prandial Analog Insulin Market Growing Rap
Slide 16: PH20 Coinjection Accelerates Insulin Absorption
PH20 Coinjection Accelerates Insulin Absorption Resulting in a Characteristic Ultrafast PK Profile "Fast-In": Twice the insulin exposure in the first hour "Fast-Out": Half as much exposure beyond 2 hours Greater (Cmax) and earlier (Tmax) peak exposure 16
Slide 17: ADA 2010 Phase 2 Meal Study in Type 2 Diabetes
ADA 2010 - Phase 2 Meal Study in Type 2 Diabetes Primary Objective: Compare test meal glycemic excursions (0-4h) following individually dose-optimized doses of Lispro, Lispro+PH20 and Regular+PH20 Study Population: 21 T2DM on high doses (>80U/d) of insulin Protocol: 3 dose-escalation test meal visit
Slide 18: Type 2 Study Confirms Observations Seen in Previous Trials
Study in Type 2 Patients Confirms Observations Seen in Previous Trials Earlier and Greater Peak Exposure Tmax reduced to 44 minutes from 74 minutes (p=0.007) Cmax was 174% higher(p<0.0001) Faster In and Faster Out Exposure Profile Exposure in the first hour increased to 188% (p< 0.0001) Exposure aft
Slide 19: Recombinant Human Insulin+PH20 Comparable to Lispro Alone
Recombinant Human Insulin+PH20 - Safe, PK and Efficacy Comparable to Lispro Alone Designed to assess safety of 12 weeks of tid dosing and demonstrate non- inferiority in treatment of patients with T1DM of Insulin-PH20 and lispro Results presented at Diabetes Technology Society November 2010 19 Resul
Slide 20: Two Ongoing Phase 2 Studies of Analogs +/- PH20
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 crossover Designed to demonstrate meaningful improvement of lispro-PH20 and/or aspart-PH20 vs. Humalog in patients with T1DM or T2DM Results availa
Slide 21: Halozyme's Ultrafast Insulin Clinical Studies
Halozyme's Ultrafast Insulin Clinical Studies Euglycemic Clamp Studies in Healthy Volunteers Proof of Concept Study (Vaughn et al. DTT May, 2009) PH20 Dose Selection Study (Posters at IDF and DTS 2009) Variability Study (Poster at DTS 2009) Comprehensive Analog Study (Oral presentation, ADA 2010; po
Slide 22: 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 23: PEGPH20 - HA Depletion Represents A Novel Mechanism
HA-rich halos found on many types of aggressive tumors (breast, prostate, pancreatic) HA mediates resistance to chemotherapy and inhibits access of protective immune cells to the tumor cells PEGPH20 depletion of HA collapses HA dependent pericellular halos on tumor cells HA TUMOR CELL + PEGPH20=Halo
Slide 24: Hyaluronan Overproduction is Common in Malignancy
Hyaluronan Overproduction is Common in Malignancy 87% HA High 46% HA High Approximately 20-30% of all solid tumors overexpress HA to varying degrees All HA overexpressing tumors tested in preclinical models respond to PEGPH20 which has activity alone and enhances activity of other chemotherapeutics
Slide 25: PEGPH20 Demonstrated Antitumor Activity Alone and with Docetaxel
PEGPH20 Demonstrated Antitumor Activity Alone and When Combined with Docetaxel IV PEGPH20 monotherapy in HA-positive PC3 prostate tumors Combination of PEGPH20 with docetaxel resulted in synergistic anti- tumor activity (survival improvement of 225% for PEGPH20 + docetaxel vs. 59% for docetaxel alon
Slide 26: PEGPH20 - Unique Approach for Treatment of Solid Tumors
PEGPH20 - Unique Approach for Treatment of Solid Tumors Hyaluronan is a major component of the tumor matrix PEGPH20 disrupts tumor matrix via unique mechanism of action and may enhance cancer cell sensitivity to chemotherapeutics Two Phase 1 multicenter, open-label, dose evaluation trials of IV admi
Slide 27: HTI-501 (conditionally active recombinant human cathepsin)
HTI-501 (conditionally active recombinant human cathepsin) Disfiguring scars (keloids, hypertrophic scars) and aesthetic applications, such as cellulite, have few viable treatment options rHuCATL - A temporal-spatially controlled recombinant human enzyme, can tightly control the duration and extent
Slide 28: Milestones for 2010
Milestones for 2010 Presentation of PEGPH20 preclinical data, 2Q10 Presentation of Phase 1 three analogs +/- PH20 clamp study at ADA 2Q10 Presentation of Phase 2 standard meal study in T2DM patients at ADA, 2Q10 Expanded PEGPH20 program, start of additional Phase 1 clinical trial, 3Q10 U.S patent is
Slide 29: Potential Milestones for 2011
Potential Milestones for 2011 Announcement of top line Phase 3 HyQ results by Baxter, 1H11 Start of PEGPH20 Phase 2 clinical trial in pancreatic cancer, 3Q11 Start of HTI-501 ex-U.S. proof of concept study in aesthetic medicine, 3Q11 Completion of two insulin Analog-PH20 Phase 2, 3x/day treatment st
Slide 30: Programs Target Over $20 Billion in Late Stage Product Opportunities
Halozyme's Programs Target Over $20 Billion in Late Stage Product Opportunities Roche's Herceptin SC in Phase 3 pivotal trial, $5.1B WW product, MabThera(r) SC in Phase 1, $5.9B WW product Baxter BioScience's HyQ with rHuPH20 in pivotal Phase 3, $6B WW market Baxter rollout of FDA approved HYLENEX i
Slide 31: Halozyme Therapeutics - Supplementary Slides
Halozyme Therapeutics - Supplementary Slides Investor Presentation December 8, 2010 31
Slide 32: 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 33: Herceptin SC - Maximal Benefit as Adjuvant Treatment
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 Herceptin SC
Slide 34: Herceptin SC - Phase 3 Clinical Trial Design
Herceptin SC - Phase 3 Clinical Trial Design Registration trial began Oct 2009, full enrollment 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/cyclophosphamide
Slide 35: 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, December 5 Primary endpoint - PK trough concentration for S
Slide 36: MabThera SC - Phase 3 Trial Design
MabThera(r) SC - Phase 3 Trial Design Roche expects to initiate in Q4 2010 Purpose: Investigate the pharmacokinetics, efficacy and safety of MabThera (rituximab) SC versus MabThera IV in patients with previously untreated follicular non-Hodgkin's lymphoma Patients receive either IV or SC MabThera, w
Slide 37: Herceptin and MabThera/Rituxan - ~$11 Billion 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 37 (CHART) ~54% of sales in EU/Int'l. in 2009
Slide 38: Potential Advantages of SC Roche Biologics vs. IV Administration
Potential Advantages of SC Roche Biologics vs. IV Administration Greater convenience - patients can be treated at physician office, potential for patients to self-administer Roche developing ready-to-use pre-filled administration device, simpler administration, not an infusion-bag prepared by pharma
Halozyme Therapeutics — Canaccord Cardiovascular, Diabetes & Obesity Conference 2010 on 6ix