Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Investor Presentation (November 2005)
34 slides from Halozyme Therapeutics's investor presentation, Nov 29, 2005
Slide 1: Company Overview November 2005
Company Overview November 2005 Jonathan Lim, MD President and CEO
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
HYLENEX drug product targeting $300M+ market, partnered with Baxter, and FDA response to NDA pending Product portfolio is BROAD and DEEP Same enzyme formulated with marketed injectable drugs to improve their performance in approved indications (e.g., ENHANZED anti-TNF-alpha) Same enzyme delivered on
Slide 4: Halozyme Therapeutics, Inc.
San Diego-based company, incorporated in 1998 Listed on American Stock Exchange (ticker: HTI) Cash position at end of Q2 2005 - $10.1 million Market capitalization - $94 million as of 10/18/05 50 million shares outstanding Halozyme Therapeutics, Inc.
Slide 5: Product Pipeline
Product Target indication(s) HYLENEX* Ophthalmic anesthesia, drug & fluid infusion Chemophase(tm) Bladder cancer rHuPH20 IV Oncology, neurology, cardiology Enhanzed products Anti-TNF-alpha for RA, IFN-beta for MS HTI-101; HTI-401 Oncology, inflam- mation; neurology Research Pre- clinical Phase 1 & 2
Slide 6: Market Opportunities
Product Indications U.S. Market HYLENEX Ophthalmic anesthesia $50 million HYLENEX Drug and fluid infusion $200 - 300 million Chemophase Superficial bladder cancer $600 - 700 million rHuPH20 IV Oncology, neurology, cardiology >$1 billion Market Opportunities
Slide 7: Multi-Horizon Growth Strategy
Focus of presentation Multi-Horizon Growth Strategy HYLENEX Enhanzed drug products Chemophase rHuPH20 IV for systemic indications HTI-101, HTI-401 HTI Value Horizon 1 Commercialize late stage products with low development risk and high upside Horizon 2 Develop products serving unmet medical needs an
Slide 8: Horizon Opportunities
Horizon 1 Opportunities HYLENEX Enhanzed drug products Horizon 1 Commercialize late stage products with low development risk and high upside Horizon 2 Develop products serving unmet medical needs and large markets Horizon 3 Develop other product candidates in pipeline 4 8 12+ 0
Slide 9: HYLENEX proposed labeled indications
Proposed 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." Drug & fluid infusion Indication Description Enhances diffusion of
Slide 10: HYLENEX: For Ophthalmic Anesthesia
Local Anesthetic + HYLENEX HYLENEX: For Ophthalmic Anesthesia HA
Slide 11: Eye Safely Immobilized for Cataract Surgery
Eye Safely Immobilized for Cataract Surgery
Slide 12: U.S. Ophthalmic Anesthesia Market
U.S. Ophthalmic Anesthesia Market HYLENEX targets 1.2 million cataract surgeries utilizing local injection anesthesia Relevant market for Hyaluronidase 100% = 2.8 million cataract surgery procedures Topical anesthesia Local injection HYLENEX: For Ophthalmic Anesthesia Source: WHO; Optistock.com; SG
Slide 13: HYLENEX: For Drug and Fluid Infusion
Background IV access difficult to establish and maintain, especially at home Hospital admission often due to need for systemic access (e.g., antibiotics, fluids) Subcutaneous (SC) drug and fluid infusion with HYLENEX is a compelling alternative to IV access HYLENEX: For Drug and Fluid Infusion Sourc
Slide 14: HYLENEX: For Drug and Fluid Infusion
Control 2MIN rHuPH20 300ul/Min PBS HYLENEX: For Drug and Fluid Infusion
Slide 15: HYLENEX: For Drug and Fluid Infusion
Saline + rHuPH20 Saline HYLENEX: For Drug and Fluid Infusion
Slide 16: HYLENEX: Benefits of SC Infusion
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 17: SC Infusion Market Opportunity in Hospices and Nursing Homes
Source: National Home and Hospice Care Survey, 2000; The National Nursing Home Survey, 1999 Summary SC Infusion Market Opportunity in Hospices and Nursing Homes Hospices Number of hospices: 2,273 Number of current patients: 106,000 Average length of service: 47 days Nursing Homes Number of nursing h
Slide 18: 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 targets are ophthalmic anesthesia and drug & fluid infusion indications Partners may mutually agree to pursue other dosage forms and indications HYLENEX
Slide 19: Enhanzed Drug Products: rHuPH20 with Injectable Drugs
Decrease pain and tissue distortion upon injection Reduce adverse injection site reactions Change route of administration (e.g., IV to SC) Convenience & compliance Extend product lifecycle of drugs coming off patent Provide differentiation for multi-sourced drugs Enable inpatient drugs to be injecte
Slide 20: 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 Commercial Anti- Rheumatic Monoclonal Antibody IgG 10
Slide 21: 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 Commercial Interferon
Slide 22: Taking The Next Step: Product-Focused Strategy
Add value to partners 1 Develop proprietary products 2 * DESI review findings published in the Federal Register (Sept. 23, 1970; 35(185):14800-1) Generate clinical data for specific products to help Halozyme and potential business partners make better decisions: Taking The Next Step: Product-Focused
Slide 23: Initial Commercial Targets for Clinical POC Studies
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 24: Horizon Opportunities
Horizon 2 Opportunities Horizon 1 Commercialize late stage products with low development risk and high upside Horizon 2 Develop products serving unmet medical needs and large markets Horizon 3 Develop other product candidates in pipeline 4 8 12+ 0 Chemophase rHuPH20 IV for systemic indications
Slide 25: Chemophase: For Superficial Bladder Cancer
Chemophase: For Superficial Bladder Cancer
Slide 26: Chemophase: For Superficial Bladder Cancer
Chemophase: For Superficial Bladder Cancer
Slide 27: 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 28: Penetration of Chemotherapy with Chemophase in Bladder Cancer
Penetration of Chemotherapy with Chemophase in Bladder Cancer Chemotherapy alone Chemotherapy with Chemophase
Slide 29: 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 30: 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 male Systemic rHuPH20: For Ischemic Stroke
Slide 31: Systemic rHuPH20: For Ischemic Stroke
Systemic administration of rHuPH20 after experimental infarct improves survival and reduces edema in rodent 28 day ischemic stroke models rHuPH20 versus Saline 2 hrs post infarct (n=40 rats/group) Systemic rHuPH20: For Ischemic Stroke
Slide 32: PEG-rHuPH20 Serum PK Analysis
Hyaluronidases normally cleared from circulation very quickly (T1/2<3 min) PK optimization of rHuPH20 with PEGylation significantly increases T1/2 Improved serum half life of PEG-rHuPH20 also translates into improved survival in rodent models PEG-rHuPH20 Serum PK Analysis PH20 Enzymes 0 10 20 30 40
Slide 33: 2005 - 2006 Milestones
Completed Cumulase CE Mark received, 4Q04 HYLENEX NDA filed, priority review, 1Q05 Cumulase 510(k) cleared and product launched, 1H05 Chemophase IND filed, 2Q05; initiated Phase I trial, 4Q05 2005 - 2006 Milestones* * Forward-looking statement Upcoming FDA response to HYLENEX NDA pending Initiate Ch
Slide 34: Investment Summary
Robust pipeline with first product selling, second product NDA pending, third product in the clinic, and several POC studies of proprietary and partnerable projects starting next year Attractive business model effectively balancing risk and reward to drive shareholder value over the long term Consis
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