Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Investor Presentation (January 2016)
26 slides from Halozyme Therapeutics's investor presentation, Jan 13, 2016
Slide 1: 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 2: Our Focus
Our Focus To discover, develop and commercialize biopharmaceuticals that target the extracellular matrix and tumor microenvironment 2
Slide 3: Two-Pillar Strategy For Growth
Two-Pillar Strategy For Growth 3 ENHANZE™ Platform PEGPH201 Platform PEGylated form of rHuPH20 Licensing/Royalty Agreements Based On Proprietary Enzyme, rHuPH20 Investigational New Oncology Drug Studying pan-tumor potential NOTE: 1) PEGPH20 is an investigational new drug Safety and efficacy profile
Slide 4: Significant Milestones Achieved in 2015
Significant Milestones Achieved in 2015 4 PEGPH20 Program Interim clinical data at ASCO Reached targeted enrollment in Study 202 Expanded pan-tumor study of PEGPH20 in clinic Formed clinical collaboration with Eisai Selected Ventana for CDx development ✓ ✓ ✓ ✓ ✓ ✓ ENHANZE Platform Substantial ramp i
Slide 5: A Journey of Transformation and Growth
A Journey of Transformation and Growth 5 2014 - 2016 2016 - 2018 2018 - 2020 Establishing the Foundation for Growth Investing for Growth Accelerating Long-Term Growth Interim PEGPH20 data presented Value-generating licensing agreements Initiate PEGPH20 pivotal trial in pancreatic cancer Readout of P
Slide 6: PEGPH20 Goal: Improve Targeting Of Co-Administered Cancer Therapies
PEGPH20 Goal: Improve Targeting Of Co-Administered Cancer Therapies 6
Slide 7: Hyaluronan: A Physical Barrier To Cancer Therapy Access
Hyaluronan: A Physical Barrier To Cancer Therapy Access 7 Hyaluronan (HA): Glycosaminoglycan, a chain of natural sugars that accumulate around cancer cells In animal models helps create a barrier to cancer therapeutics Increased tumor interstitial pressure1,2 Vasculature compression3,4 In animal mod
Slide 8: HALO 202 Pancreatic: Target Enrollment Achieved
Total Sites 45 (US only) Enrollment Stage 1 (interim data) 146 patients Target enrollment Stage 2 114 patients Estimated top line data Q4 2016 Primary endpoints: Progression Free Survival (PFS) Rate of TE events Secondary endpoints: PFS by Hyaluronan (HA) level Overall Response Rate (ORR) Overall Su
Slide 9: HALO 202 Pancreatic: Stage 1 Interim Results
HALO 202 Pancreatic: Stage 1 Interim Results 9 PFS in HA-High2 Patients At Risk PAG 23 14 10 6 5 2 1 0 AG 21 14 7 4 0 0 0 0 AG 4.3 months PAG 9.2 months HR 0.39 (0.15, 1.04) p=0.05 1) Hingorani, et al. ASCO 2015 (Abstract #4006). 2) HA measured using Halozyme prototype companion diagnostic. Presente
Slide 10: HALO 202 Pancreatic: Stage 1 Overall Safety Profile
PAG N=74 Patients, n (%) AG N=61 Patients, n (%) Preferred Term Grade 3+ Any Grade Grade 3+ Any Grade Any AE 61 (82.4) 73 (98.6) 45 (73.8) 57 (93.4) Fatigue 13 (17.6) 50 (67.6) 11 (18.0) 42 (68.9) Nausea 5 (6.8) 41 (55.4) 2 (3.3) 27 (44.3) Anemia 14 (18.9) 31 (41.9) 10 (16.4) 32 (52.5) Edema periphe
Slide 11: HALO 202 Pancreatic: Updated Thromboembolic Events With Enoxaparin Prophylaxis
11 Enoxaparin Prophylaxis Dose TE Event Rate PAG AG Stage 1 (through Dec. 5, 2014) N/A 42% (n=74) 25% (n=61) Stage 2 (through Dec. 15, 2015) 40 mg/day; or, 40 mg/day increased to 1 mg/kg/day 29% (n=17) 29% (n=7) Started on 1 mg/kg/day 7% (n=56) 4% (n=27) TOTAL – Stage 2 12% (n=73) 9% (n=34) HALO 202
Slide 12: HALO-301 Pancreatic: Phase 3 Design
12 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 reduct
Slide 13: Companion Diagnostic Goals Achieved with Ventana
Companion Diagnostic Goals Achieved with Ventana Assay, Algorithm and Scoring approach Halozyme Prototype Ventana Specificity for HA Good Better Regulatory approval path Limited Yes FDA-approved platform widely available in Clinical Labs No Yes Consistent pathologist-based read for approval and broa
Slide 14: Ventana PEGPH20 Companion Diagnostic Approach
Ventana PEGPH20 Companion Diagnostic 14 Approach Potential Benefits Detection Rabbit Fc version HTI-601 Specific for HA Adapted for Ventana platform Scoring Pathologist Read 35-40% of HA-high population Regulatory U.S. Europe IDE submission February 2016 European Conformity Mark in planning Commerci
Slide 15: PFS Benefit and Hazard Ratio on Ventana Platform Support Design of Phase 3 Study
PFS Benefit and Hazard Ratio on Ventana Platform Support Design of Phase 3 Study 15 15 AG 6.3 months PAG 9.2 months Halozyme Prototype CDx (Stage 1 202: presented ASCO 2015) Ventana CDx (Stage1 202) HR 0.48 (0.16, 1.48) HR 0.39 (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 1
Slide 16: Studying Pan-Tumor Potential of PEGPH20
Studying Pan-Tumor Potential of PEGPH20 16 PEGPH20 Study Preclinical Phase 1 Phase 2 Phase 3 In Combination with Tumor Gemcitabine and nab-Paclitaxel (Abraxane) Pancreatic Cancer Docetaxel (PRIMAL) NSCLC Pembrolizumab (Keytruda®) Gastric/ NSCLC Eribulin (Halaven®) Breast Cancer (Eisai) Investigator
Slide 17: Focus on High Unmet Need Tumors
Focus on High Unmet Need Tumors 17 US EU5 Pancreas (PDA) – 1L 40,000 47,000 Metastatic Breast-1L HER2 Neg 32,000 34,000 Metastatic Non-Small Cell Lung– 2L 49,000 41,000 Metastatic Gastric 18,000 42,000 Source: 1 GLOBOCAN 2012, SEER database, Halozyme Estimate Estimated Cancer Incidence in 20161
Slide 18: Focus on High Unmet Need Tumors
Focus on High Unmet Need Tumors eo LJ WH Estimated Cancer Incidence in 2016! US EUS Pancreas (PDA) - 1L 40,000 47,000 Metastatic Breast-1L HER2 32,000 34,000 Neg Metastatic Non-Small Cell Lung-2L 49,000 41,000 Metastatic Gastric 18,000 42,000 Source: GLOBOCAN 2012, SEER database, Halozyme Estimate P
Slide 19: ENHANZE: Our Novel Delivery Platform
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 poten
Slide 20: ENHANZE Platform Momentum: Royalty Ramp
ENHANZE Platform Momentum: Royalty Ramp Royalty Revenue Ramp Approved Products 2013 2014 2015E >200% $9M $28-33M 20
Slide 21: ENHANZE Momentum: Partnerships Accelerating, Royalty Pipeline Building
ENHANZE Momentum: Partnerships Accelerating, Royalty Pipeline Building 21 $25M $160M 5 $23M $130M 9 $15M $113M 5 $8M $85M 6 $10M $37M 1 $20M $73M 8 Upfront Milestones/ Target Targets 3 new partnerships in 12 months Time from signing to clinic accelerating 2 new targets in clinic, HyQvia new study pl
Slide 22: ENHANZE Momentum: Partnerships Accelerating, Royalty Pipeline Building
* 3new partnerships in 12 months * Time from signing to clinic accelerating * 2new targets in clinic, HYQvia new study planned Estimated 150 targets available that may benefit from ENHANZE 2006 2007 2012 2014 Baxalta Upfront By] $10M $8M $15M $23M $25M Milestones /Target wena $37M $85M $113M $130M $
Slide 23: 2016 Financial Guidance
2016 Financial Guidance 23 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 late Q1 Ongoing clinical program in NSCLC, gastric and breast cancers Cash Flow $35M to $55M Cash to be rec
Slide 24: Value Enhancing Milestones Throughout 2016
Value Enhancing Milestones Throughout 2016 24 Goal Target Date Initiate HALO-301 Pancreatic trial End of Q1 2016 HALO-Eisai Study in Breast Cancer Patients Initiated End of Q2 2016 Advance to Dose Expansion Phase in KEYTRUDA and PRIMAL Studies (pending number of dose cohorts) 2H 2016 Report mature d
Slide 25: Investment Thesis: Platforms for Growth
Investment Thesis: Platforms for Growth 25 1 2 3 4 Two platform assets, with value across indications, tumors and therapies Encouraging data for investigational new oncology drug PEGPH20 Differentiated business model, growing ENHANZE platform revenue Expertise in tumor microenvironment and its immun
Slide 26: Investment Thesis: Platforms for Growth
Two platform assets, with value across indications, tumors and therapies Encouraging data for investigational new oncology drug PEGPH20 Differentiated business model, growing ENHANZE platform revenue Expertise in tumor microenvironment and its immunology
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