Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Jefferies Investor Presentation (June 2009)
30 slides from Halozyme Therapeutics's conference presentation, Jun 17, 2009
Slide 1: Halozyme Therapeutics Matrix Therapies for Life
Halozyme Therapeutics Matrix Therapies for Life Jefferies Investor Presentation New York, June 17, 2009
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 Ability to leverage our PH20 core technology (recombinant human hyaluronidase) across multiple therapeutic areas FDA approved enzyme Strong safety profile and IP protection Unique value proposition for partners and proprietary programs Technology is validated by partne
Slide 4: PH20 Core Technology: Targets HA in the Matrix
4 PH20 Core Technology: Targets HA in the "Matrix"
Slide 5: 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 6: Robust Pipeline of PH20 Based Product Candidates and Other Matrix Enzymes
Robust Pipeline of PH20 Based Product Candidates and Other Matrix Enzymes 6
Slide 7: Partnered Programs Based on Halozyme's Drug Delivery Technology Platform
Partnered Programs Based on Halozyme's Drug Delivery Technology Platform Enhanze Technology with Roche (up to 13 biologic targets) Enhanze Technology with Baxter BioScience (GAMMAGARD) HYLENEX with Baxter Medication Delivery 7
Slide 8: Enhanze Technology: For Partners with Injectable Biologics and Drugs
Change route of administration (IV to SC) 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 Increased volume of drug at each inject
Slide 9: Existing Alliances Drive Significant Value
Enhanze Technology with Roche (up to 13 biologic targets) Alliance worth up to $612M ($20M up-front; $111M milestones for first 3 exclusive targets; $470M up-front & milestones for 10 additional targets; $11M equity), plus royalties; $47M received to date Enhanze Technology with Baxter BioScience (G
Slide 10: Roche Enhanze Technology Alliance Progressing Well
Exercised exclusive global rights to a fourth biologic target in December 2008 and fifth target in June of 2009 Two targets are in Phase 1 clinical trials - expected completion mid-2009 Initiation of additional Roche clinical trial(s) plus milestone(s) possible in 2009 Roche Enhanze Technology Allia
Slide 11: Recent Public Disclosures Reflect Strong Momentum of Roche-Halo Progress
$612M 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) Addit
Slide 12: Enhanzed GAMMAGARD - SC Monthly Dosing at Single Site
GAMMAGARD LIQUID (GGL) - plasma derived immune globulin (IgG) indicated for primary immunodeficiency, currently given by IV infusion Growing $1B+ product franchise in $2.5B worldwide market SC IgG limited by low bioavailability (63%) and small injection site volumes, results in need for weekly dosin
Slide 13: HYLENEX Launch in Pediatric Hydration Market in 4Q09
HYLENEX Launch in Pediatric Hydration Market in 4Q09 Dedicated HYLENEX specialty sales force of pediatric reps, supported by Baxter's hospital promotional presence (IV Team sales reps, formulary specialists, etc.) Formulary approval and access received at numerous pediatric hospitals in preparation
Slide 14: Proprietary Product Candidates Target the Matrix
Proprietary Product Candidates Target the Matrix Insulin-PH20: PH20 combination with insulins for meal time diabetes therapy PEGPH20: Pegylated PH20 targets HA expressing tumors Chemophase: PH20 combination with Mitomycin for bladder cancer HTI-501: Novel Matrix remodeling enzyme for dermatology 14
Slide 15: Halozyme's Insulin-PH20 Program
Goal is to develop best-in-class rapid-acting insulin product that can surpass current analog standard of care by better mimicking physiologic insulin profile Developing proprietary insulin formulations of novel PH20 enzyme with: Fast acting analog insulin (e.g., Humalog, Novolog, Apidra) Short acti
Slide 16: Goal of Insulin Therapy Is To Replicate Normal Physiologic Insulin Response
Goal of Insulin Therapy Is To Replicate Normal Physiologic Insulin Response Source: Am Fam Physician. 2004 Aug 1;70(3):489-500 Role of fast acting insulin is to replicate normal insulin release response to meal Current meal time insulin alternatives are too slow to accomplish this goal 16
Slide 17: Failure to Match Physiologic Insulin Leads to Unmet Needs and Risk of Adverse Outcomes
Failure to Match Physiologic Insulin Leads to Unmet Needs and Risk of Adverse Outcomes * IMS Data, 2008 GFK Roper Patient Survey, N = 2,000 (projectable) Suboptimal glycemic control: Inability to control post meal blood sugar is a significant impediment to diabetes management <30% of all insulin pat
Slide 18: 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. Despite Shortcomings, Fast Acting Insulin Sales Are $3B and Growing Rapidly 0.79186431500009 0.956185096000109 1.17782748200013 1
Slide 19: 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 20: Phase 2 Lispro-PH20 Data Confirm Phase 1 Effects in T1DM Patients
* Faster, greater insulin absorption with greater and earlier peak exposure achieved: Cmax increased by 41%, p=.0007; Tmax from 49 ? 30 mins, p<.0001 Phase 2 Lispro-PH20 Data Confirm in T1DM Patients the Effects observed in Phase 1 Study "Fast In": Exposure in first hour increased 50% vs. lispro (p=
Slide 21: Change in PK Profile Leads to Significant Reduction in Mean Post-Meal Hyperglycemia
ACE Goal Change in PK Profile Leads to Significant Reduction in Mean Post-Meal Hyperglycemia * Mean peak post-meal glycemia was reduced from 174 to 147 mg/dL (p=.002). Mean insulin dose = 6 U/subject. *Two patients removed from experiment due to excessive hyperglycemia (after 110 and 120 min)
Slide 22: Phase 2 Type 1 Diabetes Meal Study Conclusions
Phase 2 Type 1 Diabetes Meal Study Conclusions Lispro-PH20 well tolerated, confirms in Type 1 patients previous findings from Phase 1 clinical trial Lispro-PH20 co-administration accelerates insulin absorption to yield more physiologic meal time insulin profile PH20 accelerates absorption of lispro
Slide 23: Insulin-PH20 Could Have Best-in-Class Product Profile vs. Standard of Care Analogs
Better glycemic control Faster, higher insulin concentrations and peak exposure (i.e., fast in) results in early glucose lowering effects and reduced post-meal hyperglycemia, which may lead to better A1C control Fast in, fast out profile is ideal for insulin pump applications Insulin-PH20 Could Have
Slide 24: Efficient Development Strategy Planned to Maximize Insulin-PH20 Program Value
Additional capital efficient clinical studies to further characterize Insulin- PH20 value proposition prior to starting pivotal studies in 2010-2011 Intra-subject PK/GD variability study underway to clarify dose reproducibility Phase 2 repeat dose (tid) treatment studies in T1DM patients comparing r
Slide 25: PEGPH20 - HA Degradation May Represent a Novel Mechanism for Cancer Treatment
HA-rich halos found on many types of aggressive tumors (breast, prostate, pancreatic) PEGPH20 collapses HA dependent pericellular halos on tumor cells Modulates resistance to chemotherapy HA TUMOR CELL + Enzyme=Halo degraded Halo PEGPH20 TUMOR CELL 25 PEGPH20 - HA Degradation May Represent a Novel M
Slide 26: IV PEGPH20 in Preclinical Model 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) + API Buffer + PEGPH20 >80% reduct
Slide 27: PEGPH20 Demonstrates Antitumor Activity Alone and With Docetaxel
PEGPH20 Demonstrates Antitumor Activity Alone and When Combined with Docetaxel IV PEGPH20 monotherapy in HA-positive PC3 prostate tumors 27 Combined dosing of PEGPH20 with docetaxel results in synergistic anti- tumor activity (survival improvement of 225% for PEGPH20 + docetaxel vs. 59% for docetaxe
Slide 28: PEGPH20 Program - Phase 1 Clinical Trial
PEGPH20 Program - Phase 1 Clinical Trial Multicenter, open-label, dose evaluation trial of IV administered PEGPH20 in advanced cancer patients began 1Q09 Safety and tolerability, PK, and PD data from oncology patients anticipated by mid-2010 Determine maximum tolerated dose & dose-limiting toxicitie
Slide 29: Milestones for 2009
Milestones for 2009 $5.5 million payment from Baxter for HYLENEX, 1Q09 Phase 1 underway for second Roche exclusive target, 1Q09 Initiated Insulin-PH20 intra-subject variability study, 1Q09 Initiated PEGPH20 Phase 1, 1Q09 Initiated Insulin-PH20 Phase 2 repeat dose (tid) study, 2Q09 Presented Insulin-
Slide 30: HALO's Unique Investment Thesis
HALO's Unique Investment Thesis Existing and potential drug delivery partnerships (Enhanze Technology, HYLENEX) may provide non-dilutive cash to fund proprietary pipeline opportunities and drive near-term value Portfolio of enzymes targeting the Matrix (PH20, PEGPH20, HTI- 501), with broad potential
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