Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Investor Presentation (October 2012)
82 slides from Halozyme Therapeutics's investor presentation, Oct 2, 2012
Slide 1: Halozyme Therapeutics, Inc. Thinking Outside the Cell
Halozyme Therapeutics, Inc. Thinking Outside the Cell(tm) October 2, 2012 Exhibit 99.1
Slide 2: Safe harbor
Safe harbor 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. These forward-looking statements and all references to financial estimates are based up
Slide 3: Presenting today
Presenting today Gregory I. Frost, Ph.D. President and Chief Executive Officer Halozyme James P. Shaffer Chief Commercial Officer Halozyme Jesper Jensen Sales & Marketing - Endocrinology Halozyme Sunil Hingorani, M.D., Ph.D. Associate Member, Clinical Research and Public Health Sciences Divisions, F
Slide 4: Halozyme's Mission
Halozyme's Mission Halozyme is a science-driven, biopharmaceutical company passionate about making molecules into medicines for patients in need
Slide 5: Our passion is fueled by the patient
Our passion is fueled by the patient
Slide 6: Complement partnered revenue streams with our own products
We will complement our partnered revenue streams with our own products in order to drive sustained growth
Slide 7: Halozyme has a continuum of opportunities
Halozyme has a continuum of opportunities VALUE CREATION TIME Partner Platform Enhanze Technology Proprietary Platform Building New Platforms Roche Baxter ViroPharma Intrexon Hylenex Analog Insulin+rHuPH20 (Analog PH20) PEGPH20 HTI-501 New indications Conditionally Active Biologics (CABs) Additional
Slide 8: Halozyme's programs benefit stakeholders across the healthcare system
Halozyme's programs benefit stakeholders across the healthcare system
Slide 9: Halozyme's pipeline has multiple shots on goal
Halozyme's pipeline has multiple shots on goal
Slide 10: Cutting-edge science is fueling Halozyme's early-stage pipeline
Cutting-edge science is fueling Halozyme's early-stage pipeline Products and Product Candidates Therapeutic Area Therapeutic Area Use/ Indication Research/ Preclinical Clinical Clinical Proprietary Product Candidates Proprietary Product Candidates Proprietary Product Candidates Proprietary Product C
Slide 11: Enhanze: Enabling subcutaneous versions of IV-administered biologics
Enhanze: Enabling subcutaneous versions of IV-administered blockbuster biologics Mid-single digits ROYALTY RATES 10% More partnerships Herceptin: $6B HyQ: $1.2B Cinryze: $320M A1AT: $? Tiered ?10% MabThera/ Rituximab : $7B
Slide 12: Roche royalty opportunities are near-term
Roche royalty opportunities are near-term Registration trial met primary endpoints Fixed dose SC co-formulation reduced dosing time to ?5 minutes, versus 30 minutes with IV European marketing application filed Q1 2012 Herceptin SC Formulation (Breast Cancer) MabThera SC Formulation (Non-Hodgkin's Ly
Slide 13: Roche continues to invest significantly in their Enhanze programs
Roche continues to invest significantly in their Enhanze programs Study Program Start Date # Patients HannaH Herceptin (Breast Cancer) 4Q09 596 SafeHer Herceptin (Breast Cancer) 2Q12 2,500 PrefHer Herceptin (Breast Cancer) 2Q11 400 SparkThera MabThera (Follicular Lymphoma) 2Q09 281 Sabrina MabThera
Slide 14: Herceptin SC: Registration trial met primary endpoints
Herceptin SC: Registration trial (HannaH) met primary endpoints in HER2+ early breast cancer SC IV 69.0 µg/mL 51.8 µg/mL Blood serum levels 45.4% 40.7% Pathological complete response Co-Primary Endpoints Non-inferiority established with overall safety profile in both arms consistent with that expect
Slide 15: SafeHer: 2,500 patient study across countries
SafeHer: 2,500 patient study across 60 countries Overall safety and tolerability for Herceptin SC in HER2+ early breast cancer patients with assisted administration using a conventional syringe and needle (vial formulation) or with assisted- and self-administration using a self-injection device in s
Slide 16: PrefHer: Intravenous vs. subcutaneous Herceptin
PrefHer: Intravenous vs. subcutaneous Herceptin Primary Endpoint Patient preference for route of Herceptin administration Secondary Endpoints Safety and efficacy Nurse satisfaction with SC formulation Perceived time savings Exploratory objective Factors that influence patient preference
Slide 17: MabThera SC non-inferior serum concentrations compared to IV
MabThera SC shown in Phase 3 trial to have non-inferior serum concentrations compared to IV Study background Randomized, open-label study to investigate the PK, efficacy and safety of MabThera SC versus IV-administered MabThera Follicular non-Hodgkin's Lymphoma No new medically relevant safety signa
Slide 18: HyQ may increase patient convenience compared to other IgGs
HyQ may increase patient convenience compared to other IgGs SC dosing Dosed monthly Single administration site Other IgGs HyQ Dosed monthly Single administration site IV Dosing Dosed weekly Multiple injection sites SC Dosing All endpoints (primary and secondary) were met Fewer systemic adverse react
Slide 19: FDA wants to understand effects of elevated anti-rHuPH20 antibodies
FDA wants to understand possible effects of exposure to elevated anti-rHuPH20 antibodies in HyQ program Evaluating existing pre-clinical datasets for gaps in coverage for elevated anti-rHuPH20 antibodies Designing pre-clinical studies to fill any potential gaps Halozyme and Baxter are:
Slide 20: ViroPharma is developing a SC formulation of Cinryze
ViroPharma is developing a SC formulation of Cinryze with rHuPH20
Slide 21: Cinryze Study 200/204 HAE subjects
Cinryze Study 200/204 HAE-Subjects: C1 INH Functional 1000 U Time (hr) = Dose administered SC Cinryze + rHuPH20 demonstrated higher C1 INH functional concentrations versus SC Cinryze alone
Slide 22: Enhanze: Enabling subcutaneous versions of IV-administered biologics
Enhanze: Enabling subcutaneous versions of IV-administered blockbuster biologics Mid-single digits ROYALTY RATES 10% More partnerships Herceptin: $6B HyQ: $1.2B Cinryze: $320M A1AT: $? Tiered ?10% MabThera/ Rituximab : $7B
Slide 23: Halozyme's Proprietary Products
Halozyme's Proprietary Products James Shaffer Jesper Ostergaard Jensen
Slide 24: Important safety information for Hylenex
Important safety information for Hylenex Hypersensitivity to hyaluronidase or any other ingredient in the formulation is a contraindication to the use of this product. Discontinue Hylenex recombinant if sensitization occurs. Hyaluronidase should not be used to enhance the absorption and dispersion o
Slide 25: Hylenex launched by Halozyme in December 2011
Launched by Halozyme in December 2011 Recombinant human enzyme indicated to increase the dispersion and absorption of other injected drugs and fluids Initial commercial focus is on hospitals and emergency departments regional anesthesia drug extravasations fluid administration in patients with diffi
Slide 26: Halozyme is building a strong commercial organization
Halozyme is building a strong commercial organization Sales and Marketing Team Seasoned management team (marketing, sales, managed markets) Built small specialty sales team Contracting Performance-based agreements in place with the primary GPO's All major government agreements in place (CMS, FSS, PH
Slide 27: 2012 Hylenex market share of hyaluronidase market
2012 Hylenex Market Share of FDA-approved Hyaluronidase Market Seasoned commercial team is successfully increasing Hylenex market share
Slide 28: Two distinct insulin market opportunities
2. Continuous SC Insulin Infusion (CSII) A concentrated market on label today Reach the primarily US patient population treated by 1,000-2,000 endocrinologists Target focused market opportunity Does not compete with insulin or pumps - it makes both of them better Engage key opinion leader validation
Slide 29: Partnering MDI and commercializing Hylenex for CSII
Partnering MDI and commercializing Hylenex pre-administration for CSII Insulin Strategic Options Insulin Pumps Multiple Injections Commercialize Partner Insulin Pumps
Slide 30: Getting ready to commercialize Hylenex for insulin pumps
Getting ready to commercialize Commercializing Hylenex for insulin pumps Hylenex is approved for pre- administration There is a market need The clinical data are compelling We have basic infrastructure already in place Complements currently marketed insulin and pumps
Slide 31: Integrated pump plan: Clinical need
Integrated pump plan Clinical need Market potential Integrated plan
Slide 32: Understanding the medical need: Key opinion leader video
Understanding the medical need: Key opinion leader video Bruce Bode, MD, FACE Atlanta Diabetes Associates Neesha Ramchandani, PNP, CDE
Slide 33: There exists a need for a faster prandial insulin
There exists a need for a faster prandial insulin
Slide 34: Normal insulin secretion
Normal insulin secretion, Modified from Polonsky et al., NEJM 1988; Insulin Secretion Illustrating the pursuit of more physiologic insulin IRI Insulin (pM+- SEM)
Slide 35: Normal insulin secretion
Normal insulin secretion, Modified from Polonsky et al., NEJM 1988; Insulin Secretion Illustrating the pursuit of more physiologic insulin Source: ADA 2012, Vaughn, et al. IRI Insulin (pM+- SEM) Analog-PH20 Analog alone
Slide 36: Normal insulin secretion
Normal insulin secretion, Modified from Polonsky et al., NEJM 1988; Insulin Secretion Illustrating the pursuit of more physiologic insulin IRI Insulin (pM+- SEM) Basal Analog-PH20 Analog alone
Slide 37: Normal insulin secretion
Normal insulin secretion, Modified from Polonsky et al., NEJM 1988; Insulin Secretion Illustrating the pursuit of more physiologic insulin IRI Insulin (pM+- SEM) Basal Pump today Analog-PH20 Analog alone
Slide 38: Normal insulin secretion
Normal insulin secretion, Modified from Polonsky et al., NEJM 1988; Insulin Secretion Illustrating the pursuit of more physiologic insulin IRI Insulin (pM+- SEM) Basal Pump today Analog-PH20 Analog alone Hylenex w/pump
Slide 39: Normal insulin secretion
Normal insulin secretion, Modified from Polonsky et al., NEJM 1988; Insulin Secretion Illustrating the pursuit of more physiologic insulin IRI Insulin (pM+- SEM) Basal Pump today Analog-PH20 Analog alone Hylenex w/pump
Slide 40: rHuPH20 makes insulin in pumps more consistent
Normal insulin secretion Modified from Polonsky et al., NEJM 1988 Analog-PH20 Analog alone Analog alone varies over same infusion set life rHuPH20 pre- administration makes same infusion set absorption more consistent Source: Halozyme poster presented at ADA 2012, Vaughn, et al. rHuPH20 makes insuli
Slide 41: Analog-PH20 is as distinct from analog insulin as analog was to regular
Analog-PH20 is as distinct from analog insulin as analog insulin was to regular human insulin Source: Morrow, et al., "Diabetes Care" 2012 (in press) Analog and analog+rHuPH20 is from 11 healthy volunteers (mean weight 73.0 +- 7.6 kg) under a similar euglycemic clamp protocol in a separate study (rH
Slide 42: Physiologic glucodynamic profile with Hylenex
Hylenex + analog Analog alone AACE post prandial glucose target Physiologic glucodynamic profile with Hylenex Source: Halozyme late-breaking poster presented at ADA 2012, Muchmore, et al.
Slide 43: Patient self-administration option under development
Patient self-administration option under development Source: Halozyme Inset tube and cannula site illustration (Inset is a trademark of Unomedical A/S)
Slide 44: Summary of clinical potential for insulin pump patients
Summary of clinical potential: What we hope to deliver for insulin pump patients
Slide 45: Integrated pump plan: Market potential
Integrated pump plan Clinical need Market potential Integrated plan
Slide 46: The U.S. insulin pump market is large and growing
The U.S. insulin pump market is large and growing Source: Internal company estimates
Slide 47: Hylenex can be available to almost 90% of pump patients
Hylenex can be available to almost 90% of pump patients with the planned administration solution Estimated 2012 Insulin Pump Market Share (% patients) 90% 10% Source: Company and Campbell Alliance Analysis Annual Report, Insulet. Available at: myomnipod.com. Accessed December 2011.
Slide 48: Pre-administration in insulin pumps could be a significant revenue opportunity
Pre-administration in insulin pumps could represent a significant revenue opportunity $25 million gross revenue per percent penetration 400,000 pump users1 $52 per vial3 120 site changes per year2 1 Using internal estimates of 440,000 pump users and 90% potential availability 2 Assumes site changes
Slide 49: Pump patients adopted analog insulin quickly
Pump patients adopted analog insulin quickly Source: IMS NPA Pump adoption was more rapid Almost exclusively commercially insured Followed and treated by leading healthcare practitioners More engaged in treatment and take active role
Slide 50: Key Opinion Leaders and market research
Key Opinion Leaders ADA 2012, Advisory Board Validated product profile as differentiated and meaningful Identified clinical trial needs to support commercialization Received public support at ADA general and product symposia Diabetes Educators Group 4, AADE 2012 Ad Board Confirmed chosen delivery so
Slide 51: Integrated pump plan: Integrated plan
Integrated pump plan Clinical need Market potential Integrated plan
Slide 52: Launching Hylenex in insulin pumps is on label today
FDA Approval March 21, 2012: This "Prior Approval" supplemental new drug application provides for the addition of language to strengthen and clarify the administration instructions for Hylenex recombinant. INDICATIONS AND USAGE 1.2 Dispersion and Absorption of Injected Drugs HYLENEX recombinant is i
Slide 53: No FDA action taken on Hylenex or insulin pump trials
No FDA action taken on Hylenex or insulin pump trials Updated referenced to Hylenex IND: #66-888 General update When the Complete Response Letter for the HyQ BLA was issued, no action was taken with regard to Hylenex Pump trial Pump trial was ongoing in July 2012 and FDA took no action on trial Aug.
Slide 54: Hylenex commercialization plan highlights
Physicians Nurses Pharmacists Patient Patient Training Representative Medical Science Liaison Insurance Pharmacy/Mail Order Approval Services Copay Support Hylenex(r) Commercialization plan highlights
Slide 55: Pre-launch checklist
Updated label for proposed use Generated clinical proof of concept and clinical data Validated potential via extensive market research Selected delivery solution Gained Key Opinion Leader (KOL) support Created commercialization plan Built commercial leadership and infrastructure Execute Phase 4 stud
Slide 56: Halozyme's Proprietary Programs
Halozyme's Proprietary Programs Gregory I. Frost, Ph.D. Sunil Hingorani, M.D., Ph.D. H. Michael Shepard, Ph.D.
Slide 57: Significant unmet medical need in pancreatic cancer
There is significant unmet medical need with pancreatic cancer, but the chemotherapy backbone is evolving Potential Future of Care Advances Current Standard of Care Metastatic Halozyme's Approach PEGPH20 Surgery Gemcitabine (GEM) Early stage resectable Phase 3 results expected 2H12 Limited to patien
Slide 58: Breaching the pancreas cancer sanctuary
Breaching the pancreas cancer sanctuary
Slide 59: Scope of the problem in pancreas cancer
Scope of the problem in pancreas cancer Lowest 1-year and 5-year survivals for any cancer Median survival <6 months >80% of patients have inoperable disease at time of diagnosis No improvement in survival in last 15 years
Slide 60: Clinical challenges in pancreas cancer
Clinical challenges in pancreas cancer Hard to detect Spreads rapidly Resistant to all forms of chemo- and radiotherapies
Slide 61: Pancreas cancers are hypodense (hypoperfused)
Pancreas cancers are "hypodense" (hypoperfused): They have a decreased blood supply
Slide 62: Pancreas cancer: It takes a village
Pancreas cancer: It takes a village
Slide 63: Stromal complexity in pancreas cancer
Stromal complexity in pancreas cancer: The solid tumor organ Immune Dynamics Stromal fibroblasts and Matrix deposition Cell of Origin Cancer Stem Cell TAM Treg MDSC Angiogenesi s PS C Collagen Molecular targets Biomarkers Mechanisms of initiation, progression, metastasis Angiogenesi s HA
Slide 64: Altering intratumoral physical dynamics to advantage
Changing the game: Altering intratumoral physical dynamics to advantage in pancreas cancer
Slide 65: Changing the biology of the disease with PEGPH20
Breaching the sanctuary of pancreas cancer: Changing the biology of the disease with PEGPH20 Hard Fibrotic Hypovascular Soft Cellular Hypervascular
Slide 66: Creating a newly vulnerable disease
Breaching the sanctuary of pancreas cancer: Creating a newly vulnerable disease Normal Pancreas Pancreas Cancer Pancreas Cancer Treated with PEGPH20 Drug Lectin
Slide 67: PEGPH20 as a single agent increased tumor perfusion
Treatment with PEGPH20 as a single agent showed increased tumor perfusion Mean Ktrans Baseline Day 1 Day 2 End of Cycle 1 Tumor 0.057 0.147 0.242 0.212 Liver 0.011 0.091 0.018 0.034 Baseline 24hrs post-dose ASCO 2012
Slide 68: Rationale to incorporate PEGPH20 into future pancreas cancer backbone
Chemotherapy Radiotherapy Immune checkpoint regulators Monoclonal antibodies Nanoparticles Rationale to incorporate PEGPH20 into the future backbone for pancreas cancer
Slide 69: Cutting-edge science is fueling Halozyme's early-stage pipeline
Cutting-edge science is fueling Halozyme's early-stage pipeline Products and Product Candidates Therapeutic Area Therapeutic Area Use/ Indication Research/ Preclinical Clinical Clinical Proprietary Product Candidates Proprietary Product Candidates Proprietary Product Candidates Proprietary Product C
Slide 70: PEGPH20 companion diagnostic
PEGPH20 companion diagnostic can help identify which solid tumors could benefit from PEGPH20 treatment TSG6/Fc PHARMACOGENOMICS "PATIENT SELECTION FOR BEST CLINICAL RESPONSE" HA+3 HA+2 HA+1 HA0 Pre Rx Post Rx PHARMACODYNAMICS "HIT THE TARGET" Patient Population CDx Identify Target Patients Treatment
Slide 71: Cutting-edge science is fueling Halozyme's early-stage pipeline
Cutting-edge science is fueling Halozyme's early-stage pipeline Products and Product Candidates Therapeutic Area Therapeutic Area Use/ Indication Research/ Preclinical Clinical Clinical Proprietary Product Candidates Proprietary Product Candidates Proprietary Product Candidates Proprietary Product C
Slide 72: Conditionally Active Biologics selected for activity in disease microenvironment
Conditionally Active Biologics (CABS) are selected for preferential activity in the disease microenvironment Proteins With Well- Understood Pharmacology Enzymes Antibodies Growth Factors Cytokines High throughput mutagenesis Selection for disease specific activity CAB Candidates
Slide 73: HTI-501: A novel conditionally active biologic
HTI-501: A novel conditionally active biologic Background Initiated Phase 1/2 ex- US trial 3Q11 1Q12 Phase 1/2 complete ? well tolerated, no SAEs Began Phase 2 Target ? POC data from Phase 2 3Q12 4Q12/1Q13 Imaging technology used to quantify a dimple's change in volume/depth HTI-501 (recombinant hum
Slide 74: Financial Update
Kurt Gustafson Financial Update
Slide 75: Operating Expense: deploying capital efficiently
Operating Expense We are focused on deploying capital efficiently
Slide 76: Revenue is 45% of total operating expenses
Over the last 10 quarters, our revenue is 45% of total operating expenses
Slide 77: Halozyme's 2012 Income Statement
Halozyme manufactures based on firm partner orders and is reimbursed when product ships Halozyme's 2012 Income Statement
Slide 78: Revised 2012 financial guidance
Revised 2012 financial guidance due to timing of receipt of milestone payment Halozyme's 2012 Income Statement
Slide 79: Upcoming Roche programs drive profitability
Upcoming Roche programs drive profitability 2013 2014 2015 *HyQ approval timeline dependent on resolution of questions in CRL. Herceptin trastuzumab MabThera rituximab MabThera rituximab Herceptin trastuzumab Herceptin trastuzumab
Slide 80: Closing Remarks
Gregory I. Frost, Ph.D. Closing Remarks
Slide 81: Milestones for proprietary and partnered programs
Milestones (for proprietary and partnered programs) Present full data set from Phase 3 Herceptin SC trial File Herceptin SC marketing application in EU Present additional data from insulin pump trials Disclose full data set from insulin + rHuPH20 treatment studies Present HTI-501 clinical proof-of-c
Slide 82: Complement partnered revenue streams with our own products
We will complement our partnered revenue streams with our own products in order to drive sustained growth
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