Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Investor Presentation (June 2006)
28 slides from Halozyme Therapeutics's investor presentation, Jun 28, 2006
Slide 1: Company Overview June 2006
Company Overview June 2006
Slide 2: 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 could be affe
Slide 3: Investment Highlights
Halozyme's core competence is to develop and commercialize biotechnology products both productively and efficiently Early product commercialization and technology partnerships should generate cash that can be reinvested into exciting growth opportunities Broad and deep product pipeline targeting sig
Slide 4: Halozyme Therapeutics, Inc.
San Diego-based biopharmaceutical company, incorporated in 1998 Listed on American Stock Exchange (ticker: HTI) Cash position at end of Q1 2006 - $17.6 million Market capitalization - $150 million as of 6/15/06 61 million shares outstanding Halozyme Therapeutics, Inc.
Slide 5: Halozyme's Core Competence
Development and commercialization of biotechnology products with rapid time to market Initial molecular biology activities ? NDA submission in 21 mos. NDA submission ? FDA approval in 8 1/2 months High productivity with effective resource allocation and capital efficiency 2 U.S. FDA approvals achiev
Slide 6: Product Pipeline
Product Target indication(s) HYLENEX* Drug & fluid infusion Chemophase(tm) Bladder cancer rHuPH20 IV Oncology, neurology, cardiology Enhanze(tm) Technology Anti-TNF-alpha for RA, IFN-beta for MS HTI-101; HTI-401 Oncology, inflam- mation; neurology Research Pre- clinical Phase 1 & 2 Phase 3 In regist
Slide 7: HYLENEX: For Drug and Fluid Infusion
Labeled indications* "For use as an adjunct to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; as an adjunct in subcutaneous urography for improving the resorption of radiopaque agents." * DESI review findings published in the Federal Register (September 23, 1970
Slide 8: Intravenous Access: When Things Go Right...
"It's tough to deal with kids and their parents if you have to stick them several times to start the IV..." "After we have tried and failed, we give up and call an outside specialized company... that's about half the time and it adds significant cost" Intravenous Access: When Things Go Right...
Slide 9: Intravenous Access: When Things Go Wrong...
Bruising Infiltration Infection Phlebitis Extravasation Extravasation + 10 days Intravenous Access: When Things Go Wrong...
Slide 10: HYLENEX for SC Infusion: A New Route of Administration
Starting a subcutaneous infusion site is easy for the caregiver . . . .. . . and convenient for the patient, even at home Can use butterfly needle Can insert SC anywhere in the body (no misses) Especially useful for: Patient with poor venous access Agitated patients who repeatedly remove their IV li
Slide 11: INFUSE-LR Study
Baseline Baseline Mid-Infusion (200 cc) Mid-Infusion (200 cc) INFUSE-LR Study End-Infusion (400 mL) End-Infusion (400 mL) Side-by-Side Simultaneous Sub-Q Infusions Randomized controlled Phase IIIB study of subcutaneous hydration of lactated Ringer's (LR) +/- Hylenex in 54 volunteer subjects Hylenex
Slide 12: INFUSE-LR Study: Key Results
Four Times the Flow Rate Half the Edema Severity of End-Infusion Edema (Mean ? SD) 3.1 ? 0.6 None 0 Minimal 1 Mild 2 Moderate 3 Severe 4 1.5 ? 0.7 (N = 47) Hylenex Placebo p < 0.0001 Rate of Infusion (mL/hr) Mean ? SD 0 100 200 300 400 500 600 p < 0.0001 464 ? 42 Hylenex (N = 47) Placebo 118 ? 15 IN
Slide 13: HYLENEX: Sales & Marketing Deal with Baxter
Baxter to market, distribute, and sell HYLENEX in US and Puerto Rico Baxter and Halozyme are equal partners in commercialization of HYLENEX Initial target is drug & fluid infusion indication Partners may mutually agree to pursue other dosage forms and indications Baxter has exercised its option to m
Slide 14: HYLENEX: Targeted Launch with Baxter in 1H06
Build a strong clinical foundation with post-marketing trials to drive adoption in multiple settings of care (e.g., INFUSE-LR) Educate clinicians about benefits of Hylenex by engaging key opinion leaders and enrolling clinical Centers of Excellence Make Hylenex commercially available for drug and fl
Slide 15: Enhanze Technology: For Partners with Injectable Drugs
Decrease pain and tissue distortion upon injection Reduce adverse injection site reactions Change route of administration (e.g., IV to SC) Potentially increase dosing interval Convenience & compliance Extend product lifecycle of drugs coming off patent Provide differentiation for multi-sourced drugs
Slide 16: Enhanzed Commercial Anti-Rheumatic Monoclonal Antibody
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 local Bioavailability =59 +/- 7% Enhanzed(tm) Commercial Anti- Rheumatic Monoclonal Antibody Ig
Slide 17: Enhanzed Commercial Interferon
0.0E+00 5.0E+04 1.0E+05 1.5E+05 2.0E+05 2.5E+05 3.0E+05 3.5E+05 4.0E+05 0 10 20 30 40 50 Time (Hours) Local Serum Interferon Levels (I-125 Counts/ml) in rats Bioavailability =61% Local +rHuPH20 Intravenous Local Local +rHuPH20 Enhanzed(tm) Commercial Interferon
Slide 18: Next Step: Conduct Clinical Studies with Commercial Compounds
2004 US Sales for Drug Class Anti-TNF-alpha drug for rheumatoid arthritis $4.2 billion IFN-beta drug for multiple sclerosis $1.7 billion Currently marketed macromolecule >$1 billion Currently marketed small molecule ~$1 billion Total ~$8 billion Source: IMS (2004); HTI analysis Target Currently Mark
Slide 19: Chemophase: For Superficial Bladder Cancer
Chemophase: For Superficial Bladder Cancer
Slide 20: Chemophase: For Superficial Bladder Cancer
Chemophase: For Superficial Bladder Cancer
Slide 21: Randomized Clinical Trial of Bovine PH20 in Bladder Cancer
Mitomycin Mitomycin + Bovine PH20 Mean age (range) 62.8 (44-80) 67.3 (49-84) Men/Women 17/11 18/10 Primary tumors 15 16 Recurrent tumors 13 12 Mean Follow Up (range) 21.1 (6-32) 20.2 (6-32) Tumor Recurrence (%) 9/28 (32.1%) 2/28 (7.1%) P<0.05 P<0.05 Source: Maier and Baumgartner, 1989 Randomized Cli
Slide 22: Penetration of Chemotherapy with Chemophase in Bladder Cancer
Penetration of Chemotherapy with Chemophase in Bladder Cancer Chemotherapy alone Chemotherapy with Chemophase
Slide 23: Chemophase Market Opportunity in Superficial Bladder Cancer
63,210 new cases of urinary bladder cancer in the US1,2 499,199 prevalent cases of urinary bladder cancer3,4 At least 6 treatment cycles of mitomycin and Chemophase Source: 1 American Cancer Society, 2005; 2 ~70% of new cases are "superficial" disease (AUA Bladder Cancer Guidelines Panel, 1999); 3 N
Slide 24: Systemic rHuPH20: For Ischemic Stroke
Stroke can cause brain edema leading to further tissue damage and higher mortality Tissue edema is important in multiple disease states, including stroke, myocardial infarction, and oncology 6 hrs post infarct Ischemic stroke in a 61 year-old man Systemic rHuPH20: For Ischemic Stroke
Slide 25: Proof of Concept Edema Data
rHuPH20 IV after experimental infarct reduces edema in rodent 28 day stroke models Brain is in a closed, tight space and is highly sensitive to any increase in pressure Proof of Concept Edema Data
Slide 26: Proof of Concept Survival Data
PEG-rHuPH20 rHuPH20 versus Saline 2 hrs post infarct (n=40 rats/group) rHuPH20 IV after experimental infarct improves survival in rodent 28 day stroke models Improved serum half life of PEG-rHuPH20 also translates into improved survival in rodent models Proof of Concept Survival Data
Slide 27: 2005 - 2006 Milestones
2005: Completed on time Cumulase 510(k) cleared and product launched, 1H05 Chemophase IND filed, 2Q05; initiated Phase I trial, 4Q05 HYLENEX NDA approved, 4Q05 2005 - 2006 Milestones* * Forward-looking statement 2006: Upcoming Complete INFUSE-LR trial for HYLENEX, 1H06 Complete enrollment of Chemoph
Slide 28: Investment Highlights
Productive and efficient development and commercialization of biotechnology products with track record of success with FDA Near-term value from commercialization of approved products and prospective deal flow from technology partnerships Long-term value from broad and deep product pipeline targeting
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