Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — 28th Annual J.P. Morgan Healthcare Conference (January 2010)
42 slides from Halozyme Therapeutics's conference presentation, Jan 11, 2010
Slide 1: Halozyme Therapeutics: Matrix Therapies for Life
Halozyme Therapeutics Matrix Therapies for Life Jonathan Lim, M.D., President and CEO 28th Annual J.P. Morgan Healthcare Conference San Francisco, January 13, 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 commercial and clinical stage assets with significant revenue potential and near-term value drivers Core technology is FDA approved rHuPH20 (recombinant human hyaluronidase) enzyme ("PH20") Technology validated by partnershi
Slide 4: Halozyme's Technology Foundation
Novel Matrix Therapeutics Differentiated Products Biologics Toolbox for Partners Halozyme's Technology Foundation Strong patent protection and lifecycle extension Diversified, robust pipeline/ portfolio Increased footprint in high growth biologics market Differentiated products with best-in-class po
Slide 5: Multifunctional rHuPH20 Enzyme Platform Targets Over $14 Billion in Late-Stage Opportunities
Multifunctional rHuPH20 Enzyme Platform Targets Over $14 Billion in Late-Stage Product Opportunities Roche's Herceptin SC in pivotal Phase 3, $5B product, two additional targets have entered the clinic Baxter BioScience's GAMMAGARD SC in pivotal Phase 3, $6B addressable market Baxter rollout of FDA
Slide 6: PH20 Core Technology: Targets Hyaluronan (HA) in Matrix
6 PH20 Core Technology: Targets Hyaluronan (HA) in "Matrix"
Slide 7: PH20 Core Technology: Targets Hyaluronan (HA) in Matrix
7 PH20 Core Technology: Targets Hyaluronan (HA) in "Matrix"
Slide 8: PH20 Core Technology: Targets Hyaluronan (HA) in Matrix
8 PH20 Core Technology: Targets Hyaluronan (HA) in "Matrix"
Slide 9: HA reconstitutes within hours
HA reconstitutes within 24 to 48 hours
Slide 10: PH20 with Remicade - IV Like Bioavailability in a Preclinical Model
IgG 10mg/kg local Bioavailability = 59 +/- 7% 0.0E+00 2.0E+05 4.0E+05 6.0E+05 8.0E+05 1.0E+06 1.2E+06 1.4E+06 1.6E+06 1.8E+06 2.0E+06 0 10 20 30 40 50 60 70 80 90 100 110 120 130 Time (Hours) Serum Antibody Levels (I-125Counts/ml) in rats IgG 10mg/kg IV Bioavailability = 100% Bioavailability = 94 +/
Slide 11: Halozyme Pipeline Development Status
Halozyme Pipeline Development Status 11
Slide 12: Enhanze Technology: For Partners with Injectable Biologics and Drugs
Change route of administration from clinic based IV to home based SC therapy Reduce adverse injection site reactions Decrease pain and tissue distortion upon injection Convenience and compliance Economic benefits Value proposition Deliver more drug to intended targets Allow drugs to work faster Incr
Slide 13: Existing Alliances Drive Significant Value
Existing Alliances Drive Significant Value Over $100 million of alliance related cash received to date Enhanze Technology with Roche (up to 13 biologic targets, 5 currently exclusive) Alliance worth up to $612M ($20M up-front; $111M milestones for first 3 exclusive targets; $470M up-front & mileston
Slide 14: Public Disclosures Reflect Strong Momentum of Roche-Halo Progress
Partnership signed, 3 exclusive biologic targets elected (Dec 06) YE06 YE07 YE08 YE09 4th exclusive biologic target elected 1st Phase 1 (n=70, mid-09 completion) Annual maintenance fees (Dec 08) 2nd Phase 1 (n=48, mid-09 completion) (Jan 09) 5th exclusive biologic target elected (Jun 09) Phase 3 (n=
Slide 15: Roche Enhanze Alliance Moving Forward - Subcutaneous Herceptin in Phase 3
Herceptin IV Humanized monoclonal antibody for treatment of HER2-overexpressing breast cancer (BC) Herceptin for 1 year is standard of care in HER2-positive early BC Ongoing clinical trial (HERA) may extend treatment by additional year, results expected in 2012 ~ $5B worldwide sales and growing Herc
Slide 16: Enhanzed GAMMAGARD - SC Monthly Dosing at Single Site
GAMMAGARD LIQUID - plasma derived immune globulin (IgG) indicated for primary immunodeficiency, approved for IV infusion Growing $1B+ product franchise in ~ $6B worldwide market Current SC IgG limited by low bioavailability (63%) and small injection site volumes results in need for weekly dosing wit
Slide 17: Baxter BioScience - Enhanzed GAMMAGARD Addressable Worldwide IgG Market
Baxter BioScience - Enhanzed GAMMAGARD Addressable Worldwide IgG Market ~ $6 Billion Market Size Reflects The Broad Clinical Applications Of IgG Source: Baxter 17
Slide 18: HYLENEX Launched in Pediatric Hydration
HYLENEX Launched in Pediatric Hydration October 2009 at ACEP Pediatric hydration trial results published in October in peer-reviewed journal PEDIATRICS Label revision 12/09 added clinical studies section with pediatric hydration study description and additional information on pediatric use Perceived
Slide 19: Proprietary Product Candidates Target the Matrix
Proprietary Product Candidates Target the Matrix Ultrafast Insulin - PH20 with regular and rapid-acting analog insulins for diabetes PEGPH20 - Pegylated PH20 targets HA expressing tumors Chemophase - PH20 combination with Mitomycin for bladder cancer HTI-501 - Novel Matrix remodeling enzyme targets
Slide 20: 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 21: Goal of Intensive Insulin Therapy: Mimic Normal Physiologic Insulin Response (1 of 2)
Goal of Intensive Insulin Therapy: Mimic Normal Physiologic Insulin Response (1 of 2) 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
Slide 22: Goal of Intensive Insulin Therapy: Mimic Normal Physiologic Insulin Response (2 of 2)
Goal of Intensive Insulin Therapy: Mimic Normal Physiologic Insulin Response (2 of 2) 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 s
Slide 23: 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 24: Fast Acting Insulin Sales Are $3B and Growing Rapidly
1 Source: IMS 2009 EU =France, Germany , Italy, Spain, UK 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, Fast Acting Insulin Sales Are $3B and Growing Rapidly 0.791
Slide 25: Phase 2 Meal Study in Type 1 Diabetes
Phase 2 Meal Study in Type 1 Diabetes 4-way crossover standardized test meal study in type 1 diabetes Objective: compare PK and glucose profiles in response to Humulin R +/- PH20 and Humalog +/- PH20 Primary endpoint: PK AUC0-60 Secondary endpoints: Multiple PK parameters, glycemic excursion Study d
Slide 26: PH20 Changed Lispro PK Profile and Reduced Post-Meal Hyperglycemia
PH20 Changed Lispro PK Profile and Led to Significant Reduction in Post-Meal Hyperglycemia "Fast In": Exposure in first hour increased 50% vs. lispro (p=.0002)* "Fast Out": Exposure after 2 hours reduced ~45% vs. lispro (p=.027) ACE Goal 26
Slide 27: Phase 2 Type 1 Diabetes Meal Study Conclusions
Phase 2 Type 1 Diabetes Meal Study Conclusions PK results for these preparations confirmed in type 1 patients previous findings from Phase 1 PH20 accelerated insulin absorption compared to insulin alone, combination yielded more physiologic mealtime insulin PK profiles Greater and earlier peak expos
Slide 28: Efficient Development Strategy to Characterize Ultrafast Insulin Value Proposition
Ongoing clinical studies further characterize Ultrafast Insulin Phase 1 euglycemic glucose clamp study comparing 3 marketed fast acting analog insulins +/- PH20 Phase 2 standard meal study in T2DM patients Phase 3 enabling studies Phase 2 3x/day treatment study in T1DM patients compares regular Insu
Slide 29: Ultrafast Insulin Could Have Best-in-Class Product Profile
Less mealtime hyperglycemia More patients meet established goals for postprandial hyperglycemia Accelerated insulin exposure (i.e., fast in) results in early glucose lowering effects and reduced post-meal hyperglycemia Fast in, fast out profile is ideal for insulin pump applications Ultrafast Insuli
Slide 30: PEGPH20 - HA Depletion Represents A Novel Mechanism for Cancer Treatment
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 31: Hyaluronan (HA) Overproduction is Common in Malignancy
Hyaluronan (HA) 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 chemotherapeu
Slide 32: IV PEGPH20 Results in Rapid Drop in Tumor Interstitial Fluid Pressure
IV PEGPH20 in Preclinical Model Results in Rapid Drop in Tumor Interstitial Fluid Pressure (IFP) * IM PC3 tumor pressure in tumor bearing mice measured 20 minutes prior and for 2 hours following IV injection of 10,000 units of PEGPH20 (n=3), or carrier buffer (n=3) ** Heldin et al, Nature Reviews Ca
Slide 33: 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 Combined dosing of PEGPH20 with docetaxel resulted in synergistic anti- tumor activity (survival improvement of 225% for PEGPH20 + docetaxel vs. 59% for docetaxel
Slide 34: PEGPH20 Program Summary
PEGPH20 Program Summary 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 Multicenter, open-label, dose evaluation trial of IV administered PEGPH20 in advanced cancer patients
Slide 35: Milestones for 2010
Milestones for 2010 Presentation of PEGPH20 preclinical data, 2Q10 Presentations of new Ultrafast Insulin data: Phase 1 comparison of three analogs +/-PH20 euglycemic clamp study, 2Q10 Phase 2 standard meal study in T2DM patients, 2Q10 Phase 2 treatment study 3x/day in T1DM patients, regular Insulin
Slide 36: Halozyme's Programs Driving Significant Value for Shareholders
Halozyme's Programs Driving Significant Value for Shareholders Roche's Herceptin SC in pivotal Phase 3, $5B product, two additional targets have entered the clinic Baxter BioScience's GAMMAGARD SC in pivotal Phase 3, $6B addressable market Baxter rollout of FDA approved HYLENEX in pediatric hydratio
Slide 37: Halozyme Therapeutics - Supplementary Slides
Halozyme Therapeutics - Supplementary Slides J.P. Morgan Healthcare Conference January 13, 2010 37
Slide 38: 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 39: Herceptin - A Large and Growing $5 Billion Market Opportunity
% Herceptin - A Large and Growing $5 Billion Market Opportunity +44% ~65% of sales in EU in 2008 *2005-2008 year end exchange rates from Oanda.com Source: Roche annual reports, 2005-2008, Genentech annual report 2008 WW Sales* $ Millions
Slide 40: 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 40 Chemotherapy dosing Herceptin use during adjuvant treatment Herceptin
Slide 41: Herceptin SC - Phase 3 Clinical Trial Design
Herceptin SC - Phase 3 Clinical Trial Design Registration trial began October 2009, N = 552, women with HER2- positive early breast cancer, HANNAH Pre-operative treatment with 8 cycles of chemotherapy (docetaxel followed by 5-FU/epirubicin/cyclophosphamide) concurrent with IV or SC Herceptin, follow
Slide 42: Potential Advantages of Herceptin SC vs. Herceptin IV
Potential Advantages of Herceptin SC vs. Herceptin IV Greater convenience - patients can be treated at physician office or at home Simpler administration - ready-to-use pre-filled administration device, not an infusion-bag prepared by pharmacist Faster infusion time - expected to be <5 minutes vs. 3
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