Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Investor Presentation (September 2016)
30 slides from Halozyme Therapeutics's investor presentation, September 2016
Slide 1: Building a Premier Oncology Biotech: Two Pillar Strategy for Growth
Building a Premier Oncology Biotech: Two Pillar Strategy for Growth Dr. Helen Torley President & CEO September 2016
Slide 2: Forward-Looking Statements
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 regul
Slide 3: Halozyme: 2016 and Beyond
Halozyme: 2016 and Beyond Diversified Oncology Biotech Fueled by High-Growth Royalty Platform ► Proprietary Oncology Pipeline – PEGPH20: Phase 3 asset with pan tumor potential – 2 pre-clinical assets – Strong Intellectual Property ► Proven, Proprietary ENHANZE™ Platform – 3 royalty generating produc
Slide 4: Two-Pillar Strategy for Growth
Two-Pillar Strategy for Growth ENHANZE™ Platform Oncology Pipeline 6 Global Licensing & PEGPH203, unique Phase 3 asset Collaboration agreements • Primary indication – Pancreatic cancer, ~25,000 Recurring mid-single digit HA-HIGH population4 royalties • Additional indications • Approved and developme
Slide 5: PEGPH20 Goal: Improve Targeting Of Co-Administered Cancer Therapies
PEGPH20 Goal: Improve Targeting Of Co-Administered Cancer Therapies
Slide 6: Hyaluronan (HA) Can Be a Barrier to Therapeutic and Immune Cell Access to Tumor Cells
Hyaluronan (HA) Can Be a Barrier to Therapeutic and Immune Cell Access to Tumor Cells HA Surrounding a Cancer Cell HA is a Structural Carbohydrate that: • Stabilizes the Tumor Microenvironment (TME) • Is associated with decreased survival1 • Compromises Access to the Tumor – Increases tumor intersti
Slide 7: PEGPH20 Targets Hyaluronan in the TME
PEGPH20 Targets Hyaluronan in the TME In HA-High Tumor Animal Models, Removal of HA by PEGPH20 Demonstrated to: Decrease Decompress Increase Increase Increase intratumoral vasculature perfusion access for access for pressure therapeutics immune cells PEGPH20 6
Slide 8: PEGPH20 Increases Accumulation and Effect of anti-PDL1 in Animal Models
PEGPH20 Increases Accumulation and Effect of anti-PDL1 in Animal Models SKOV3/HAS2 Ovarian Tumor Model KPC-derived HA-High Pancreatic Anti-Human PD-L1 Alexafluor 488 Tumor Model p = 0.006 Is o t y p e c o n t r o l P E G P H 2 0 / is o t y p e c o n t r o l 20000 2500 A n t i- P D -L 1 T u m o r V o
Slide 9: Advancing Demonstration of PEGPH20 Pan-Tumor Potential
Advancing Demonstration of PEGPH20 Pan-Tumor Potential PEGPH20 Study In Preclinical Phase 1 Phase 2 Phase 3 Combination Tumor with Gemcitabine and nab- Pancreatic1 HALO 301: First Patient Dosed in March 2016 Paclitaxel Cancer (ABRAXANE®) Pembrolizumab Gastric/ Goal: Advance to Dose (KEYTRUDA®) NSCLC
Slide 10: Study HALO 202 | Pancreatic
Study HALO 202 | Pancreatic Phase 2 Trial: 1L Stage IV pancreatic cancer PEGPH20 plus ABRAXANE and gemcitabine versus ABRAXANE and Design gemcitabine alone Primary endpoints: Progression-free Survival (PFS) and Thromboembolic (TE) Event rate Number of Sites 45 (US) 146 patients: 43 HA-HIGH Stage 1 S
Slide 11: HALO 202 | Pancreatic: Stage 1 PFS Results in HA High Patients
HALO 202 | Pancreatic: Stage 1 PFS Results in HA High Patients Bullock, et. al. “Final Analysis of Stage 1 Data" American Society of Clinical Oncology (ASCO) Annual Meeting 2016. 10
Slide 12: HALO 202 | Pancreatic: Stage 1 Overall Safety Profile
HALO 202 | Pancreatic: Stage 1 Overall Safety Profile Treatment Related AEs >25% PAG (n = 74) AG (n = 61) Patients, n (%) Patients, n (%) Preferred Term Any Grade Grade ≥ 3 Any Grade Grade ≥ 3 Any AE 73 (98.6) 63 (85.1) 57 (93.4) 45 (73.8) Fatigue 52 (70.3) 15 (20.3) 42 (68.9) 11 (18.0) Peripheral e
Slide 13: HALO-301 | Pancreatic: Phase 3 Trial Ongoing
HALO-301|Pancreatic: Phase 3 Trial Ongoing Metastatic PEGPH20 + ABRAXANE® + PDA gemcitabine (PAG) Primary Endpoints: Progression-Free High-HA Survival (PFS) patients Overall Survival (OS) ABRAXANE® + gemcitabine N=420 (AG) + placebo • Randomized (2:1 PAG:AG), double-blind, placebo-controlled, global
Slide 14: Focus: Tumors with High Unmet Need
Focus: Tumors with High Unmet Need Advanced Non-Small Cell Lung, 1L Metastatic Pancreatic Cancer 2L Metastatic Gastric, 2L Stage IV Breast (HER2-) Annual Incidence Annual Incidence ~65,000 ~180,000 (US and EU 5) (US and EU 5) Estimated % HA-HIGH 35-40% Projected % HA-HIGH 30% Target HA-HIGH Populati
Slide 15: ENHANZE Platform
ENHANZE™ Platform 14
Slide 16: ENHANZE Value Demonstration
ENHANZE Value Demonstration ENHANZE Value ENHANZE Product Alternative Proposition Subcutaneous Number and Alternate SC: frequency of injections per month 2014 Lifecycle 2030 EU patent expiration Management patent extension1 for Herceptin IV2 Mean chair time in 198-329 mins / visit 25-133 mins / visi
Slide 17: ENHANZE Momentum: Expanding Partnerships, Advancing Royalty Pipeline
ENHANZE Momentum: Expanding Partnerships, Advancing Royalty Pipeline 2006 2007 2012 2014 2015 One-time Upfront $20M $10M $8M $15M $23M $25M Total Milestones $37-47M $37M $85M $113M $130M $160M / Target1 Targets 8 1 6 5 9 5 Recurring Mid-single Digit Royalties on Net Sales 1 Assumes all developmental
Slide 18: ENHANZE Portfolio Opportunity
ENHANZE Portfolio Opportunity The Top 3 • $5B+ Royalty-Eligible Sales in 20251 • Recurring mid-single digit royalties The Next 5 • $25B+ Sales in 20251 • Recurring mid-single bococizumab2 rivipansel2 digit royalty 4 targets selected and non-disclosed 23 Additional Targets Licensed Potential Future O
Slide 19: The Top 3: Leading Commercial Assets Paying Recurring Royalties
The Top 3: Leading Commercial Assets Paying Recurring Royalties Estimated 2015 Total Brand Revenues, First Approvals Indications Listed Indications, Ex- US and ex-Japan EMA: Sept. 2013 • HER2+ Metastatic Breast Cancer • HER2+ Early Breast $3.8B1 Cancer EMA: Mar. 2014 • Follicular Lymphoma • Diffuse
Slide 20: Herceptin SC and MabThera SC: Strong Conversion Driving Royalty and Revenue Growth
Herceptin SC and MabThera SC: Strong Conversion Driving Royalty and Revenue Growth 50+ countries 15+ countries 40+ countries *Information provided during Roche investor update (Jul. 21, 2016) 19
Slide 21: Marketed Products: Royalty Revenue Ramp
Marketed Products: Royalty Revenue Ramp $23.7M 48% CAGR First Half Second Half First Half 2015 2015 2016 20
Slide 22: The Next 5: Considerable Royalty Revenue Potential Upon Approval
The Next 5: Considerable Royalty Revenue Potential Upon Approval Global Revenue ENHANZE Upcoming Partner Product Projection, All Program Event/Catalyst Indications – 20252 Stage Est. Completion Phase $5B Phase 1 1: Sept 20171 Est. Primary $8B Phase 1 Completion Date: Jan 20171 ~$11B3 Phase 1 Complet
Slide 23: ENHANZE Portfolio Opportunity
ENHANZE Portfolio Opportunity The Top 3 • $5B+ Royalty-Eligible Sales in 20251 • Recurring mid-single digit royalties The Next 5 • $25B+ Sales in 20251 • Recurring mid-single bococizumab2 rivipansel2 digit royalty 4 targets selected and non-disclosed 23 Additional Targets Licensed Potential Future O
Slide 24: Oncology Pipeline Update
Oncology Pipeline Update
Slide 25: PEG-ADA2 Immune Checkpoint Inhibitor
PEG-ADA2 Immune Checkpoint Inhibitor Adenosine: Attractive immune checkpoint target • Abnormally high levels accumulate in the tumor microenvironment leading to immunosuppression AMP Adenosine CD73 ATP CD39 PEG-ADA2: Engineered human enzyme ATP targeting adenosine • Checkpoint inhibitor Tumor • Anti
Slide 26: HTI-1511 Anti-EGFR Antibody Drug Conjugate
HTI-1511 Anti-EGFR Antibody Drug Conjugate ADC overcomes mutation resistance and selectively kills tumor cell ADC = antibody-drug conjugate HTI-1511: Anti-EGFR Antibody Drug Conjugate • Works in both wild type and mutated KRAS and ADC BRAF tumor animal models • Complete tumor responses observed in P
Slide 27: Financial Update
Financial Update
Slide 28: 2016 Financial Guidance
2016 Financial Guidance January 2016 August 2016 Revenue $110M to $125M $140M to $150M Operating Expenses $240M to $260M $245M to $260M Cash Flow $35M to $55M $65M to $85M Year-end Cash $140M to $160M $170M to $190M 27
Slide 29: Value Enhancing Milestones Throughout 2016
Value Enhancing Milestones Throughout 2016 Goal Target Date Initiate HALO-301|Pancreatic trial Complete ✓ Initiate HALO-Eisai Study in Breast Cancer Patients Complete ✓ Project Reporting Mature ORR and PFS from HALO 202 | Q4 2016 Pancreatic Initiate 90% of study sites in Study 301 Dec. 2016 Initiate
Slide 30: Two-Pillar Strategy for Growth
Two-Pillar Strategy for Growth ENHANZE™ Platform Oncology Pipeline 6 Global Licensing & PEGPH203, unique Phase 3 asset Collaboration agreements • Primary indication – Pancreatic cancer, ~25,000 Recurring mid-single digit HA-HIGH population4 royalties • Additional indications • Approved and developme
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