Building a Premier Oncology Biotech

Transcription

1 Building a Premier Oncology Biotech August 208

2 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 995. Examples of such statements include possible activity, benefits and attributes of PEGPH20, future product development and regulatory events and goals, anticipated clinical trial results and strategies, product collaborations, our business intentions and financial estimates and results, including projected revenue amounts. 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.

3 Halozyme Two Pillar Strategy Removing Biological Barriers to Treatment ENHANZE Enhancing Delivery of Treatments PEGPH20 Late Stage Investigational New Product ENHANZE image from The 5 Steps to Infuse HYQVIA. 2

4 ENHANZE Pillar

5 207: Transformative Year for ENHANZE Pipeline June 207: RITUXAN HYCELA U.S. FDA Approval Aug 207: Initiate Phase trial Sept 207: Landmark -target I-O deal Sept 207: Expanded collaboration, new target Nov 207: Initiate Phase 3 trials, daratumumab SC Dec 207: Four-target collaboration 4

6 Commercial Products Driving Robust ENHANZE Royalty Growth Growing Royalty Revenue Average Mid-Single Digit Royalty Rate Across Partnerships $64M $5M $3M $9M Ex-U.S. Launch U.S. Launch 6/7 Quarterly reporting lag in 207; expect to see revenue reflected in

7 ENHANZE : ~$ Billion Royalty Revenue Potential in 2027 Based on marketed products and targets projected to be in clinical testing in 208 $B ~$ Billion $500M Approved Products Potential Future Products,2 Assumes additional products, including Darzalex and Opdivo (nivolumab), are globally approved and launched in multiple indications Includes projections for subcutaneous versions of targets not approved or commercially available. Innovator revenues based on Bloomberg analyst projections. Conversion rates based on Halozyme internal projections. 2 6 Royalty revenue projection includes targets selected but not yet disclosed.

8 ENHANZE Progress and Value Acceleration Perjeta/ Herceptin FDC ALXN20 Undisclosed Undisclosed Undisclosed Undisclosed CD73 Undisclosed 7

9 ENHANZE Offers Four Paths for Differentiation and Value Creation for Partners Reduced Treatment Burden and Healthcare Costs 2 Potential for Competitive Differentiation 3 New Intellectual Property and Exclusivity 4 Changing US Reimbursement and Care Landscape 8

10 Increasing Value of Agreements Driven by Regulatory and Commercial Success One-time Upfront $20M $0M $8M $5M $23M $25M $05M $30M $40M Milestones/ Target $37-47M $37M $85M $3M $30M $60M $60M $60M $60M Targets Recurring Average Mid-single Digit Royalties on Net Sales Assumes all developmental and commercial milestones per target achieved and paid to Halozyme. 9

11 Phase 3 Oncology Asset: PEGPH20

12 Pancreatic Ductal Adenocarcinoma (PDA): The Need 65,000 people diagnosed with metastatic pancreas cancer each year 55,250 will die within 2 months of diagnosis 2 By 2030, pancreas cancer projected to be the 2 nd leading cause of cancer death 3 High levels of Hyaluronan (HA) associated with poor survival in pancreas cancer 4 SEER , Globocan 202, DRG Epidemiology data. 2 Statistics adapted from the American Cancer Society's publication, Cancer Facts & Figures Rahib et al, Cancer Res Whatcott, et al. AACR (203)

13 Hyaluronan (HA) Can Be a Barrier to Therapeutic and Immune Cell Access to Tumor Cells HA is a Structural Carbohydrate that: Stabilizes the Tumor Microenvironment (TME) Is associated with decreased survival and immunosuppression in the TME 2,3 HA Surrounding a Cancer Cell Compromises Access to the Tumor Increases tumor interstitial pressure 4,5 Compresses vasculature 6,7 Can decrease therapeutic and immune cell access 8 Whatcott, et al. AACR (203) 2 Rosengren et al, Cancer Res 206;76(4 Suppl):Abstract # Zhang et al, Oncoimmunology 206; 5(6) 4 Brekken et al. Anticancer Res. 20:3503 (2000) 5 Provenzano and Hingorani, Br J Cancer 08: (203) 6 Thompson et al. Mol Cancer Ther. 9:3052 (200) 7 Stylianopoulos et al. PNAS. 0:8632 (203) 8 Singha et al.. Mol Cancer Ther. 4:523 (205) 9 Rilla et al. JHC. 56:90 (2008) HA (Red) surrounding a single breast cancer cell overexpressing HAS3 (Bright Green) 9 2

14 Tumor HA Overexpression Associated with Shorter Survival in Pancreas Cancer Retrospective Evaluation of Pancreatic Cancer Survival in ~50 Patients HA-Low Median Survival: 24.3 months HA-High Median Survival: 9.3 months H.R. 2.6 p=0.037 In US and EU-5, estimated 25,000 HA-High metastatic pancreas cancers annually (~35-40%) 2,3 Whatcott et al: Clin Cancer Res 205, 2: HA staining by HABP. Scoring algorithm assessed percent staining and intensity. 2 3 Annual Incidence, SEER , Globocan 202, Medscape; Estimated HA-High %, Halozyme estimates. 3 Not all HA-High patients may be eligible for PEGPH20.

15 PEGPH20 Targets Hyaluronan (HA) in the Tumor Microenvironment In HA-High Tumor Animal Models, Removal of HA by PEGPH20 Demonstrated to: Decrease intratumoral pressure Decompress vasculature Increase perfusion Increase access for therapeutics Increase access for immune cells PEGPH20 4

16 PEGPH20 Targets and Degrades Hyaluronan Before PEGPH20 MPA# After + PEGPH20 Gemcitabine Hard Fibrotic Hypovascular Soft Cellular Hypervascular Provenzano, et al. Cancer Cell. 202,2(3):48. 5

17 PEGPH20 Pancreas Cancer Program De-risking Event Timeline Phase 2 randomized, controlled HALO-202 study initiated 206 Companion Diagnostic algorithm and cutpoint established Initiated Phase 3 HALO-30 study 207 HALO-202 data supportive of Phase 3 trial design Validated companion diagnostic HALO-30 ongoing at >200 centers in 22 Countries Project target PFS events between December 208 and February 209 with data to follow 6

18 HALO-30 Pancreatic: Global Phase 3 Trial Enrolling in 22 Countries L Metastatic PDA High-HA patients N= PEGPH20 + ABRAXANE + gemcitabine (PAG) ABRAXANE + gemcitabine (AG) + placebo Primary Endpoints: Progression-Free Survival (PFS) Overall Survival (OS) Randomized (2: PAG:AG), double-blind, placebo-controlled, global Project to achieve target number of PFS events between December 208 and February 209, triggering final data collection, cleaning and interim analysis 7

19 Pan-Tumor Testing of PEGPH20 Breast Cancer Gastric Cancer, NSCLC Pancreas Cancer, Gastric Cancer Gall Bladder Cancer, Cholangiocarcinoma No further clinical development planned on the Phase 2 portion of this study. 2 Data presentation at ESMO No further testing of PEGPH20 with single agent Keytruda in gastric cancer and NSCLC planned. 8

20 ~$B Potential Sales Opportunity in HA-High Metastatic Pancreatic Ductal Adenocarcinoma (PDA) 65,000 Diagnosed Metastatic PDA Annually US and EU 5 25,000 Estimated number of HA-High patients ~$B Projected potential global sales opportunity for successful therapy in metastatic PDA % of population 2 SEER , Globocan 202, DRG Epidemiology data. 2 Halozyme estimates for HA-High %. 3 DRG Epidemiology data, Halozyme internal estimates. 9

21 Financial Update

22 208 Financial Guidance Update January 208 August 208 Net Revenue $5M to $25M $25M to $35M Operating Expenses $230M to $240M $230M to $240M Operating Cash Burn ($75M) to ($85M) ($75M) to ($85M) Debt Repayment ~($95M) ~($95M) Includes YoY royalty growth of 25% - 30% Does not include potential new ENHANZE agreements Disciplined expense control, flat to 207 Excludes impact of financing, repayment of debt principal Includes royaltybacked and Oxford/SVB loans Year-end Cash $305M to $35M $30M to $320M 2

23 Core Elements of Value Creation in 208 ENHANZE 25%-30% Royalty Revenue Growth Multiple catalysts 6 Phase starts 4 Phase 3 Darzalex trials ~$B royalty potential in 2027 PEGPH20 - Pancreatic Phase 3 PFS Events: Dec. 208 Feb. 209 ~$B potential sales opportunity Financial Cash balance exiting 208 of $30M-$320M PEGPH20 - Pan-Tumor Potential data from two trials Capabilities Readiness for PEGPH20 BLA/MAA submissions in 209 Support ENHANZE partner progress 22

24 Building a Premier Oncology Biotech August 208