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Fourth Quarter 2015 Earnings Call February 29, 2016

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Page 1: Fourth Quarter 2015 Earnings Call - s21.q4cdn.coms21.q4cdn.com/.../Halozyme-4Q2015-Earnings-Presentation-02-29-1… · SG&A Expense $10.6 $8.4 27% Net Income (Loss) $4.3 ($5.3) --EPS

Fourth Quarter 2015

Earnings Call

February 29, 2016

Page 2: Fourth Quarter 2015 Earnings Call - s21.q4cdn.coms21.q4cdn.com/.../Halozyme-4Q2015-Earnings-Presentation-02-29-1… · SG&A Expense $10.6 $8.4 27% Net Income (Loss) $4.3 ($5.3) --EPS

Forward-Looking Statements

All of the statements in this presentation that are not statements of historical

facts constitute forward-looking statements within the meaning of the Private

Securities Litigation Reform Act of 1995. Examples of such statements include

future product development and regulatory events and goals, anticipated

clinical trial results and strategies, product collaborations, our business

intentions and financial estimates and results. These statements are based

upon management’s current plans and expectations and are subject to a

number of risks and uncertainties which could cause actual results to differ

materially from such statements. A discussion of the risks and uncertainties

that can affect these statements is set forth in the Company’s annual and

quarterly reports filed from time to time with the Securities and Exchange

Commission under the heading “Risk Factors.” The Company disclaims any

intention or obligation to revise or update any forward-looking statements,

whether as a result of new information, future events, or otherwise.

1

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Two-Pillar Strategy For Growth

2

ENHANZE™ Platform PEGPH201 Platform

n

CH2 CH2 OCH2 O

CH3

N

H

O

CH2 CH2 OO CH2

CH3

N

H

O

n

CH2 CH2 OO CH2

CH3

N

O H

n

n

CH2 CH2 OCH2 O

CH3

N

H

OCH2 CH2 OO CH2

CH3

N

O H

n

PEGylated form of rHuPH20

Licensing/Royalty Agreements Based On Proprietary Enzyme, rHuPH20

Investigational New Oncology DrugStudying pan-tumor potential

NOTE: 1) PEGPH20 is an investigational new drug Safety and efficacy profile have not been established; it is not currently available forcommercial distribution.

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PFS Benefit and Hazard Ratio on Ventana

Platform Support Design of Phase 3 Study

33

AG 6.3 months

PAG 9.2 months

Halozyme Prototype CDx(Stage 1 202: presented ASCO 2015)

Ventana CDx(Stage1 202)

HR0.48 (0.16, 1.48)

HR0.39 (0.15, 1.01)

AG 4.3 months

PAG 9.2 months

0 2 4 6 8 10 12 14 0 2 4 6 8 10 12 14

Risk23 14 10 6 5 2 1 021 14 7 4 0 0 0 0

PAGAG

At 22 12 10 7 5 2 0 021 14 8 5 1 0 0 0

PAGAG

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4

HALO-301|Pancreatic: Phase 3 Design

• Randomized (2:1 PAG:AG), double-blind, placebo-controlled, global

• Plan to initiate March 2016, approximately 200 sites in 20 countries

• Interim analysis when target number of PFS events reached

• PFS powered with a hazard ratio of 0.59 (to detect a 41% risk reduction

for progression)

PEGPH20 + ABRAXANE® +

gemcitabine (PAG)

ABRAXANE® + gemcitabine

(AG) + placebo

Metastatic

PDA

High-HA

patients

N=420

Primary Endpoints: Progression-Free Survival (PFS)Overall Survival (OS)

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Studying Pan-Tumor Potential of PEGPH20

5

PEGPH20 Study

Preclinical Phase 1 Phase 2 Phase 3InCombination

withTumor

Gemcitabineand nab-Paclitaxel (Abraxane)

Pancreatic Cancer

Docetaxel(PRIMAL) NSCLC

Pembrolizumab(Keytruda®)

Gastric/ NSCLC

Eribulin(Halaven®)

BreastCancer(Eisai)

Investigator Sponsored Trials in Pancreatic Cancer: SWOG, UCSF, MSKCC

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Partner TargetUS /

OUSPreclinical Phase 1 Phase 3 Approved

Herceptin SC OUS

Mabthera SC OUS

HYQVIA US

HYQVIA EU

Daratumumab --

Rivipansel--

Bococizumab--

Humira --

To be announced

--

ENHANZE: Our Novel Delivery Platform

6

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ENHANZE: Our Novel Delivery Platform

Potential Benefits:

• Facilitate transition of IV therapies to

subcutaneous administration

• Reduce multiple injections

• Enable large volume of biologics to

be delivered subcutaneously

• Reduce time required for drug

administration

• Life cycle management, including

potential patent life extension

7

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Roche Update: Herceptin SC and Mabthera SC1

8

1) Information provided during Roche investor update (Jan. 28, 2016).

Page 10: Fourth Quarter 2015 Earnings Call - s21.q4cdn.coms21.q4cdn.com/.../Halozyme-4Q2015-Earnings-Presentation-02-29-1… · SG&A Expense $10.6 $8.4 27% Net Income (Loss) $4.3 ($5.3) --EPS

4Q 2015 4Q 2014 % Change

Total Revenue $52.2 $30.4 72%

Royalty Revenue $9.5 $4.0 136%

Bulk rHuPH20 Sales $9.3 $6.0 55%

Hylenex® recombinant $4.3 $4.1 5%

Collaboration Revenue $29.1 $16.2 80%

Fourth Quarter 2015 Financial Highlights1

$ U.S. in Millions (unaudited)

NOTE: 1) Dollar amounts and percentages, as presented, are rounded.

9

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4Q 2015 4Q 2014 % Change

Total Revenues $52.2 $30.4 72%

Total Operating Expense $46.8 $34.2 37%

Cost of Product Sales $8.4 $6.1 37%

R&D Expense $27.7 $19.7 41%

SG&A Expense $10.6 $8.4 27%

Net Income (Loss) $4.3 ($5.3) --

EPS $0.03 ($0.04) --

Cash and marketable securities $108.3 $135.6 --

Fourth Quarter 2015 Financial Highlights1

$ U.S. in Millions, except EPS (unaudited)

NOTE: 1) Dollar amounts and percentages, as presented, are rounded.

10

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FY 2015 Guidance2

Total Revenues $135.1 $110 - $115

Operating Expense $162.5 $160 - $170

Cash Burn $27.3 $20 - $30

Cash and marketable securities $108.3 $105 - $115

Full Year 2015 Financial Highlights1

$ U.S. in Millions, except EPS

NOTE: 1) Dollar amounts and percentages, as presented, are rounded.

2) Revenue, Operating Expense and Cash Burn guidance provided on August 10, 2015 during Q2 2015 earnings

presentation, cash balance provided on November 9, 2015 during Q3 2015 earnings presentation.

11

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2016 Financial Guidance

12

2016 Notes

Revenue $110M to $125M• No new ENHANZE

partnership revenue in 2016

guidance

Operating

Expenses$240M to $260M

• Phase 3 pancreatic cancer

study initiating in March

• Ongoing clinical programs in

NSCLC, gastric and breast

cancers

Cash Flow $35M to $55M

• Cash received in Jan 2016

o $25M Lilly upfront

o $150M Royalty Backed

Debt Financing

• Assumes $22M principal

repayment to Oxford/SVBYear-end Cash $140M to $160M

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Fourth Quarter 2015

Earnings Call

February 29, 2016