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FORM 8-K HALOZYME THERAPEUTICS INC (Unscheduled Material Events) Filed 11/29/2005 For Period Ending 11/28/2005 Address 11588 SORRENTO VALLEY ROAD SUITE 17 SAN DIEGO, California 92121 Telephone (858) 794-8889 CIK 0001159036 Fiscal Year 12/31

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Page 1: HALOZYME THERAPEUTICS INCd1lge852tjjqow.cloudfront.net/CIK-0001159036/065c... · HYLENEX drug product targeting $300M+ market, partnered with Baxter, and FDA response to NDA pending

FORM 8-K

HALOZYME THERAPEUTICS INC

(Unscheduled Material Events)

Filed 11/29/2005 For Period Ending 11/28/2005

Address 11588 SORRENTO VALLEY ROAD SUITE 17

SAN DIEGO, California 92121

Telephone (858) 794-8889

CIK 0001159036

Fiscal Year 12/31

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Table of Contents

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT Pursuant to Section 13 OR 15(d) of

The Securities Exchange Act of 1934

November 28, 2005

HALOZYME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)

Registrant’s telephone number, including area code: (858) 794-8889

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

� Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

� Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

� Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

� Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Nevada 000-49616 88-0488686

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

11588 Sorrento Valley Road, Suite 17, San Diego, California 92121

(Address of principal executive offices) (Zip Code)

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TABLE OF CONTENTS

Item 7.01 Regulation FD Disclosure. Item 9.01 Financial Statements and Exhibits.

SIGNATURES EXHIBIT 99.1

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Table of Contents

Item 7.01 Regulation FD Disclosure.

Attached hereto as Exhibit 99.1, which is incorporated herein by reference, is a copy of certain slides used by the Company in making investor presentations and that are expected to be used in subsequent presentations to interested parties, including analysts and stockholders.

This information is being furnished pursuant to Item 7.01 of this Report and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by Halozyme Therapeutics, Inc. under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference. This Report will not be deemed an admission as to the materiality of any information in this Report that is being disclosed pursuant to Regulation FD.

Please refer to page 2 of Exhibit 99.1 for a discussion of certain forward-looking statements included therein and the risks and uncertainties related thereto.

Item 9.01 Financial Statements and Exhibits.

(c) Exhibits. Exhibit No. Description

99.1 Halozyme Therapeutics, Inc. Investor Presentation dated November 2005.

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Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Halozyme Therapeutics, Inc. November 28, 2005 By: /s/ David A. Ramsay

David A. Ramsay Secretary and Chief Financial Officer

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EXHIBIT 99.1

Company Overview November 2005 Jonathan Lim, MD Pres ident and CEO

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The Private Securi ties Li tigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Al l statements made in this presentation that are not statements of his torical fact constitute forward -looking statements. The matters referred to in fo rward -looking statements could be affected by the risks and uncertain ties of the Company's business. Such risks inherent to the Company's business will be described in the Company's filings, when they occur, with the Securities and Exchange Commission, as well as in its press releases. The Company's actual results may d iffer materially from those expressed in or indicated by such forward -looking statements. Safe Harbor

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HYLENEX drug p roduct targeting $300M+ market, partnered w ith Baxter, and FDA response to NDA pending Product portfol io is BROAD and DEE P Same enzyme formulated with marketed injectab le drugs to improve their performance in approved indicat ions (e.g. , ENHANZED anti -TNF-alpha) Same enzyme delivered on i ts own or with marketed drugs to address new clinical indicat ions for large markets with unmet med ical needs (e.g. , Chemophase) Management team and commercial infrastructure in p lace with first enzyme p roduct already launched worldwide Investment Highl ights

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San Diego-based company, inco rporated in 1998 Lis ted on American Stock Exchange (ticker: HTI) Cash pos ition at end of Q2 2005 - $10.1 mill ion Market capi talization - $94 mill ion as of 10/18/05 50 mil lion shares outs tanding Halozyme Therapeut ics, Inc.

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Product Target indication(s) HYLENEX* Ophthalmic anesthesia, drug & fluid infus ion Chemophase(tm) Bladder cancer rHuPH20 IV Oncology, neurology, card iology Enhanzed products Anti -TNF-alpha fo r RA, IFN -beta for MS H TI-101; HT I-401 Oncology, inflam- mation ; neurology Research Pre- cl inical Phase 1 & 2 Phase 3 In registr- at ion Marketed p roduct Development status NDA filed IND fi led Product Pipeline Cumulase(tm) In vi tro ferti lization Product launched in US, EU, Japan * HYLENE X is a registered trademark of Baxter International, Inc.

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Product Indicat ions U.S. Market HYLENEX Ophthalmic anesthesia $50 mil lion HYLENEX Drug and fluid infusion $200 - 300 mill ion Chemophase Superficial bladder cancer $600 - 700 mill ion rHuPH20 IV Oncology, neurology, cardiology >$1 b illion Market Opportuni ties

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Focus of presentat ion Mult i-Horizon Growth Strategy HY LENEX Enhanzed drug p roducts Chemophase rHuPH20 IV for systemic indications HTI-101, HTI -401 HTI Value Horizon 1 Commercialize late stage products with low development risk and high ups ide Horizon 2 Develop products serving unmet medical needs and large markets Horizon 3 Develop other p roduct candidates in pipel ine 4 8 12+ Poten tial t ime to market (years) Primary product focus 0

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Horizon 1 Opportuni ties HYLENE X Enhanzed drug products Horizon 1 Commercial ize late stage products with low development risk and high ups ide Horizon 2 D evelop products serv ing unmet medical needs and large markets Horizon 3 Develop other product cand idates in pipeline 4 8 12+ 0

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Proposed labeled indications* "For use as an adjunct to increase the absorption and dispersion of other injected d rugs; for hypodermoclys is; as an adjunct in subcutaneous urography; fo r improving the resorpt ion o f radiopaque agents." Drug & flu id in fusion Ind icat ion Descript ion E nhances d iffusion of anesthesia during oph thalmic surgery 50+ years cl inical validat ion from Wyeth's Wydase(r), used in ~750,000 procedures in 1999** * DESI review findings published in the Federal Register (September 23 , 1970 ; 35(185):14800-1) ** Removed from market in 2001 due to manufactu ring issues (AAO; Roundtable discussion of Wydase Shortage, March 2005) Enhances absorpt ion and dispersion of other injected drugs and fluids (hypodermoclysis) Oph thalmic anesthesia HYLENEX (NDA pending)

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Local Anesthetic + HYLENE X HYLENEX: For Oph thalmic Anesthesia HA

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Eye Safely Immobil ized for Cataract Surgery

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U.S. Ophthalmic Anesthesia Market HYLENEX targets 1.2 million cataract su rgeries u tilizing local injection anesthesia Relevant market for Hyaluronidase 100% = 2.8 mill ion cataract surgery procedures Topical anesthesia Local injection HYLENEX: For Ophthalmic A nesthesia Source: WHO; Opt istock .com; SG Cowen; Alcon ; ASCRS Survey (2003); HTI analysis

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Background IV access difficult to establ ish and maintain, especial ly at home Hosp ital admission often due to need for systemic access (e.g., ant ibiot ics, fluids) Subcutaneous (SC) d rug and fluid infusion with HYLENE X is a compel ling al ternat ive to IV access HYLENEX: For Drug and Fluid Infus ion Source: UpToDate, 2005; American Family Physician, 2001

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Control 2MIN rHuPH20 300ul/Min PBS HYLENEX: For Drug and Fluid In fusion

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Saline + rHuPH20 Saline HYLE NEX: For Drug and Fluid Infusion

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Starting a subcutaneous infus ion s ite is easy for the caregiver . . . . . . and convenient fo r the patient, even at home Can use butterfly needle Can insert SC anywhere in the body (no misses) Especially useful fo r: Patien t with poor venous access Ag itated patien ts who repeatedly remove their IV lines Facili ties without continuous availab ili ty of sk illed p roviders to insert IVs, including home HYLENEX: Benefi ts o f SC In fusion

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Source: National Home and Hospice Care Survey, 2000; The National N urs ing H ome Survey , 1999 Summary SC Infusion Market Opportuni ty in Hospices and Nursing Homes Hospices Number o f hospices: 2,273 Number of current pat ients: 106,000 Average length o f service: 47 days Nurs ing Homes Number of nurs ing homes: 18,000 Number of current patients : 1.6 mil lion Average length of stay (range): 272 to 892 days

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Baxter to market, distribute, and sel l HYLENEX in US and Puerto Rico Baxter and Halozyme are equal partners in commercial izat ion o f H YLENEX Init ial targets are ophthalmic anesthesia and drug & fluid infusion indicat ions Partners may mutually agree to pursue other dosage forms and indications HYLENEX: Sales & Marketing Deal with Baxter

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Decrease pain and tissue dis tortion upon injection Reduce adverse injection site react ions Change route o f administration (e.g. , IV to SC) Convenience & compliance Extend product li fecycle of drugs coming off paten t Provide different iation for mult i-sourced drugs Enable inpatient drugs to be injected at home Economic benefi ts Enhanze(tm) Technology Value Proposi tion for drug dispers ion D el iver more drug to intended targets Allow drug to work faster Increase volume of drug at each injection Efficacy Enhanzed Drug Products: rHuPH 20 with Injectable Drugs

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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 Ant ibody Levels (I-125Counts /ml) in rats IgG 10mg/kg local Bioavailabi lity =59 +/- 7% Enhanzed Commercial Anti - Rheumatic Monoclonal Ant ibody IgG 10mg/kg local + rHuPH20 Bioavai labili ty =94 +/- 7% Bioavai labil ity =100% IgG 10mg/kg IV

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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 In terferon Levels (I-125 Counts/ml) in rats Bioavailabi lity =61% Local +rHuPH20 Intravenous L ocal Local +rHuPH20 E nhanzed Commercial In terferon

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Add value to partners 1 Develop proprietary p roducts 2 * DESI review find ings publ ished in the Federal Reg ister (Sept. 23, 1970; 35(185):14800-1) Generate cl inical data for specific products to help Halozyme and potential business partners make better decisions: Tak ing The Next Step: Product-Focused Strategy Conduct low cost proof of concep t (PO C) clinical studies to generate PK/tolerabili ty data Use the data to achieve two object ives Product-speci fic cl inical data more powerful than pre-cl inical data Lower cost, faster time to market fo r Enhanzed drug products Proposed labeled indicat ions* "For use as an adjunct to increase the absorpt ion and dispersion of other injected drugs; fo r hypodermoclysis; as an adjunct in subcutaneous urography; for improv ing the resorp tion of radiopaque agen ts."

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2004 US Sales for Drug Class Ant i-TNF-alpha drug for rheumatoid arthritis $4.2 bill ion IFN -beta d rug for multiple scleros is $1 .7 bil lion Currently marketed macromolecule >$1 b illion Current ly marketed small molecule ~$1 bil lion Total ~$8 b illion Source: IMS (2004); HT I analys is Target Current ly Marketed Compound Ini tial Commercial Targets fo r Clinical POC Stud ies Add value to partners 1 Develop proprietary products 2

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Horizon 2 Opportuni ties 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 pipel ine 4 8 12+ 0 Chemophase rHuPH20 IV for systemic indicat ions

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Chemophase: For Superficial Bladder Cancer

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Chemophase: For Superficial Bladder Cancer

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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 Cl inical Trial o f Bovine PH20 in Bladder Cancer In itiated Chemophase Ph I t rial in 4Q05

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Penetration of Chemotherapy with Chemophase in Bladder Cancer Chemotherapy alone Chemotherapy with Chemophase

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63,210 new cases of urinary b ladder 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 Gu idelines Panel, 1999); 3 NCI SEER Cancer Statis tics Review, 2002 ; 4 ~30% recurrence rate of treated patients with in 12 months (Southwest Oncology Group Study, 1995) Chemophase, if adopted as fi rs t line therapy with mitomycin , would target ~100,000 pat ient candidates and ~600,000 potential doses/year Chemophase Market Opportuni ty in Superficial Bladder Cancer

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Stroke can cause brain edema lead ing to further tissue damage and higher mortality Tissue edema is important in mu ltiple disease states, includ ing s troke, myocardial infarction, and oncology 6 hrs post infarct Ischemic stroke in a 61 year o ld male Systemic rHuPH20: For Ischemic Stroke

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Systemic administrat ion of rHuPH20 after experimental infarct improves su rv ival and reduces edema in rodent 28 day ischemic stroke models rHuPH20 versus Sal ine 2 hrs post infarct (n=40 rats /group) Systemic rHuPH20: For Ischemic Stroke

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Hyaluronidases normally cleared from circulation very quickly (T1/2<3 min) PK optimization of rHuPH20 with PEGylation significantly increases T 1/2 Improved serum half l ife o f PEG -rHuPH20 also translates into improved survival in rodent models PE G-rHuPH20 Serum PK Analysis PH20 Enzymes 0 10 20 30 40 50 60 70 1 10 100 1000 10000 Animal Testes Hyaluron idase PH 20 Time (min) Units / ml activ ity plasma PEG -PH20 rHuPH20 versus Saline 2 h rs post infarct (n=40 rats /group) Systemic rHuPH20: For Ischemic Stroke

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Completed Cumulase CE Mark received , 4Q04 H YLENEX NDA filed, priority review, 1Q05 Cumulase 510(k) cleared and product launched, 1H05 Chemophase IND filed, 2Q 05; initiated Phase I trial, 4Q05 2005 - 2006 Milestones* * Forward-looking statement Upcoming FDA response to HYLENEX N DA pending In itiate Chemophase Phase I/IIa t rial, 1H06 In itiate POC cl inical s tudy for hypodermoclys is, 1H06 Init iate POC clin ical stud ies for ini tial commercial targets, 2006

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Robust pipeline with first product sell ing, second product ND A pending , third product in the clinic, and several POC studies of proprietary and partnerable projects s tarting nex t year A ttract ive bus iness model effectively balancing risk and reward to drive shareholder value over the long term Consisten t delivery o f milestones by fu ll management team with demonstrated track record of success Investment Summary