Natera, Inc. · NASDAQ:NTRA
Natera — Investor Presentation (June 2018)
21 slides from Natera's investor presentation, Jun 27, 2018
Slide 1: Natera, Inc. June 2018 Investor Call
Natera, Inc. June 2018 Investor Call June 27, 2018
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding the market opportunity, products, commercial partners, user experience, clinical trials, financial performance, s
Slide 3: Agenda
Agenda • Kidney transplant rejection – New data from UCSF study demonstrates 92% sensitivity for acute rejection – Targets greater than $2bn market (estimated) with established CMS pricing at ~$2,800 per test • Breast cancer update – Preliminary data very promising, to be submitted for peer review –
Slide 4: Natera's Technology Designed to Analyze Cell-Free DNA
Natera’s Technology Designed to Analyze Cell-Free DNA Proprietary Proprietary Molecular Bioinformatics • 10+ years of experience • >20,000 targets in one reaction, no • Proprietary algorithms using HapMap, custom equipment with cfDNA, over 1 million • Low DNA input and high yield: as TCGA, Cosmic •
Slide 5: Applications Across Multiple Indications
Applications Across Multiple Indications Prenatal Care Oncology Transplant • Panorama • Lung • Renal • Horizon • Bladder • Additional indications • Vistara • Colon • Spectrum • Breast • Anora • Additional indications Confidential. Not for further reproduction or use 5
Slide 6: Unmet Need in Renal Transplant Monitoring
Unmet Need in Renal Transplant Monitoring • ~190,000 living kidney transplant recipients in the U.S. • ~20,000 kidney transplants performed in U.S. per annum1 • Approximately 15-20% suffer acute rejection in first year • Patients must be monitored throughout their lifetime for graft rejection; patie
Slide 7: UCSF Study Overview
UCSF Study Overview 292 samples from 187 patients were analyzed Classified into 4 groups by biopsy: Acute Acute Rejection AR (52 samples) Stable, Rejection, 73 52 Borderline Rejection Borderline Rejection, Other Injury Non-AR (240 Other Injury, 82 samples) 85 Stable Confidential. Not for further rep
Slide 8: Levels of Donor DNA Significantly Higher in Patients Suffering Acute Rejection
Levels of Donor DNA Significantly Higher in Patients Suffering Acute Rejection Significance level p<0.0001 Sensitivity: *** 92.3% 2.8% Positive dd-cfDNA (%) 1% threshold Specificity: 0.5% 0.5% 72.9% Area Under Negative Curve (AUC): 0.90 Non-AR Acute Rejection (n=240) (n=52) > 95% of positive results
Slide 9: Specificity Among Stable Patients is Even Higher
Specificity Among Stable Patients is Even Higher Significance level p<0.0001 Sensitivity: 92.3% 2.8% Positive Specificity: dd-cfDNA (%) 1% threshold 93.2% 0.2% Area Under Negative Curve (AUC): 0.95 Stable Only Acute Rejection (n=73) (n=52) Boxes indicate inter-quartile range, horizonal lines represe
Slide 10: Natera Assay Outperforms Competition
Natera Assay Outperforms Competition Natera study1 (n=292 samples) Bloom et al.2 (n=107 samples) Performance Metrics Sensitivity 92% (n=52) 59% (n=27) Specificity 73% (n=240) 85% (n=80) AUC 0.90 0.74 Assuming 25% Prevalence (higher risk population) NPV 97% 86% PPV 53% 57% Assuming 15% Prevalence (av
Slide 11: Addressable Market in U.S. Estimated to Exceed $2bn
Addressable Market in U.S. Estimated to Exceed $2bn • ~190,000 living with kidney transplant • ~20,000 new kidney transplants per year • CMS rate for comparable test: Months post surgery $2,841 • Testing up to 7x in year 1, 4x tests per year thereafter Confidential. Not for further reproduction or u
Slide 12: Commercialization Plan for Transplant Assay
Commercialization Plan for Transplant Assay ~20,000 transplants annually • Natera scale and experience with NGS testing provides COGS advantage 80% of • History of winning as fast follower with transplants technical superiority in the top 100 centers • Robust user experience • Distributed model with
Slide 13: Patent-Protected Technology
Patent-Protected Technology • Natera approach does not use transplant-specific markers and does not require advance determination of donor or recipient genotypes • Natera technology already protected by two granted European patents, one issued U.S. patent, and at least four pending EU and US patent
Slide 14: Oncology Update
Oncology Update Signatera™(RUO) in Breast Cancer
Slide 15: Signatera (RUO) Highly Consistent Across Tumor Types
Signatera™(RUO) Highly Consistent Across Tumor Types Positive result after treatment has always led to relapse Lung (1) Bladder (2) Colon (3) % Relapse-free survival (n=39) (n=10) (n=45) (n=14) (n=9) HR 19.8 * HR 34.5 HR 31.8 * (n=13) p < 0.005 p < 0.001 p < 0.0001 * • Avg lead time 4 mos • Avg lead
Slide 16: 3 Prospective Breast Cancer Studies for Different Indications
3 Prospective Breast Cancer Studies for Different Indications 1 PI: Laura Esserman, MD, PhD Objective: • Evaluate Signatera as marker of molecular response to neoadjuvant ISPY-2: 182 patients therapy, in comparison with radiological and pathological Neoadjuvant response criteria 327 plasma time poin
Slide 17: Study Design in Post-Treatment Setting
Study Design in Post-Treatment Setting Collaboration with University of Leicester and Imperial College of London • Study design: Blood collection every 6 months, in a cohort of 49 breast cancer patients starting at least 3 years after conclusion of treatment • Key output metrics: relapse detection r
Slide 18: HER2+ Therapeutic Decision Making in the MRD Setting
HER2+ Therapeutic Decision Making in the MRD Setting • Unmet need: Neratinib recently approved for treatment in HER2+ “ patients after a full year of trastuzumab. Only 2% survival benefit with severe side effects. Use of neratinib could be considered in patients with early stage HER2- positive breas
Slide 19: Establishing the Recurrence Monitoring Indication
Establishing the Recurrence Monitoring Indication Over 70% of relapses are distant, not local2,4 Recurrence Monitoring Protocols Oncologist / Radiologist Setting Primary Care / OBGYN Setting Stage 2+ and 70%5 of Stage 1 DCIS + 30%5 of Disease-free patients 0 – 5 years post-dx non-TNBC Stage 1 5 – 15
Slide 20: Commercialization Strategy
Commercialization Strategy • Pharma: RUO & CLIA, existing team with 18 signed deals • Oncologists, other providers – targeted directly and/or with channel partners Channels • Low hanging fruit within current guidelines: HER2+, CRC II, Lung Ib • Other indications: leverage clinical studies funded by
Slide 21: Natera
® natera’ Conceive. Deliver. POWERED BY NATERA © oanorama’ NEXT GENERATION NIPT an ‘ as horizor ADVANCED CARRIER SCREEN (®@ spectrum’ PREIMPLANTATION GENETICS @ anora’ MISCARRIAGE TEST (POC) x Evercord NEWBORN STEM CELL BANKING ae “constellation TECHNOLOGY LICENSING