Natera, Inc. · NASDAQ:NTRA
Natera — Investor Presentation (October 2019)
17 slides from Natera's investor presentation, Oct 10, 2019
Slide 1: Signatera success to date
Published validation studies in 4 cancer types (Nature, JAMA Oncology, etc.) Completion of 2 additional studies (pan-cancer monitoring and neoadjuvant breast) FDA breakthrough status ~25 biopharma partnerships $50 million partnership with BGI Draft Medicare local coverage decision in colorectal canc
Slide 2: Agenda
Agenda Signatera overview Data presented to date Key commercial pathways: Direct pharma channel Direct clinical channel Partnership in China with BGI Genomics Partnership with Foundation Medicine
Slide 3: Oncology MRD market opportunity
Oncology MRD market opportunity ctDNA / Liquid biopsy Monitoring $15B Therapy selection Early detection Based on internal company estimates
Slide 4: 10+ years of experience with cell free DNA
10+ years of experience with cell free DNA >2 million tests performed Single molecule sensitivity in a tube of blood Natera’s technology designed to analyze cell-free DNA Novel molecular method Powerful bioinformatics Reproductive health Oncology Organ transplant
Slide 5: How Signatera works
How Signatera works Sequencing of tumor tissue, to identify unique signature of tumor mutations Custom design and manufacture of personalized mPCR assay for each patient, targeting the top 16 clonal mutations found in tumor Use personalized assay to test patient’s blood for presence of circulating t
Slide 6: Why personalized and tumor-informed?
Why personalized and tumor-informed? Ultra-sensitive detection of small traces of tumor DNA Enough variants to track Ultra-deep sequencing at >100,000X NGS coverage Measure only clonal mutations, reflective of full disease burden Accurate measurement of disease burden (ctDNA quantity) Requirements f
Slide 7: Signatera validated across multiple tumor types
JAMA Oncology Clinical Cancer Research Nature Journal of Clinical Oncology 1. Reinert T, Henriksen TV, Christensen E, et al.[AMA Oncol. 2019. doi:10.1001/jamaoncol.2019.0528. 2. Coombes RC, Page K, Salari R, et al. Clin Cancer Res. 2019. doi: 10.1158/1078-0432.CCR-18-3663. 3. Abbosh C, Birkbak NJ, W
Slide 8: Signatera outperforms CT imaging for evaluating response to immunotherapy
Up to 1 in 10 patients experience pseudo-progression on imaging2 Therapy response evaluated every 6-12 weeks with CT imaging Complication Current standard of care Signatera not fooled by pseudo-progression. Better, earlier measure of response. Solution Signatera outperforms CT imaging for evaluating
Slide 9: ctDNA changes predict outcomes
ctDNA changes predict outcomes ctDNA decrease at 6 weeks correlates with 2x higher survival* ctDNA clearance at any time during treatment correlates with 100% survival* *Survivals are during the follow up period
Slide 10: Key commercial channels
Key commercial channels Direct channel Clinical Direct channel Pharma Pharma BD reps Hiring oncology focused sales reps 100K+ clinical patients/yr 50+ active pharma partners 1 million+ genetic tests/yr in China Study enrichment, Treat on recurrence, Surrogate endpoint Stage II-III CRC, more to come
Slide 11: Direct pharma channel strategy
Breakthrough Device Direct pharma channel strategy Indications: Trial enrichment Treatment on molecular recurrence Tracking neoantigens Therapy effectiveness monitoring
Slide 12: $50M oncology-focused partnership with BGI
$50M oncology-focused partnership with BGI $35 million upfront1 $15 million milestones2 Ongoing royalties on sales Benefits to Natera Signatera™ distribution in China 1. $35 million upfront to Natera. $6 million prepayment to BGI for sequencing services 2. Delivered upon achievement of key milestone
Slide 13: Stage II-III colorectal cancer
Stage II – III colorectal cancer Estimated > 1MM tests per year Use case mirrors CEA testing currently in NCCN guidelines CMS issues draft local coverage in CRC
Slide 14: Assessing risk/MRD status before adjuvant chemo
Most patients are cured with surgery alone but still receive chemotherapy Adjuvant chemo is recommended for patients at high risk of relapse High-risk patients often missed Low-risk patients significantly overtreated Serious treatment-related adverse events occur in 10-31% of patients1 Using Signate
Slide 15: Enabling a new market with Foundation Medicine
Enabling a new market with Foundation Medicine Tumor sequencing leadership Personalized tumor monitoring for patients who have had FoundationOne®CDx 100,000+ patients annually receive FMI testing 50+ active biopharma partnerships Expands access for cancer monitoring Cell free DNA leadership
Slide 16: Enabling a new market with Foundation Medicine
Enabling a new market with Foundation Medicine mooene N |, | @natera Tumor sequencing leadership Cell free DNA leadership Personalized tumor monitoring for patients who have had FoundationOne®CDx 100,000+ patients annually receive FMI testing 50+ active biopharma partnerships Expands access for canc
Slide 17: Conceive. Deliver. Thrive.
Conceive. Deliver. Thrive.