Slide 1: Natera, Inc. Fourth Quarter 2021 Earnings Call
Natera, Inc. Investor presentation Fourth Quarter 2021 Earnings Call
Slide 2: Safe harbor statement
Safe harbor statement This presentation contains forward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements regarding our market opportunity, our p
Slide 3: Recent highlights
Recent highlights ● 1.57M total tests processed in FY 2021; ~53% growth vs 2020 and >5K more than preannounce – ~439K total tests processed in Q4 2021 ● FY 2021 total revenue of $625.5M; ~60% growth vs 2020, and above top end of previous guidance range – Total revenue of $173M in Q4 2021 ● Landmark
Slide 4: Volume acceleration in 2021
Volume acceleration in 2021 1,800K 1,600K Total processed units (in thousands) 1,570K 53% 1,400K 1,200K 28% 1,027K 1,000K 20% 803K 800K 30% 668K 15% 600K 515K 44% 447K 400K 310K 200K K 2015 2016 2017 2018 2019 2020 2021 4 Not for reproduction or further distribution.
Slide 5: Strong growth trends in Q4
Strong growth trends in Q4 Total revenues Tests processed ($ in millions) (thousands) $173 439 54% 49% 35% 41% 295 $112 24% 20% 24% $83 26% 209 $67 174 $54 138 Q4 2017 Q4 2018 Q4 2019 Q4 2020 Q4 2021 Q4 2017 Q4 2018 Q4 2019 Q4 2020 Q4 2021 5 Not for reproduction or further distribution.
Slide 6: New products contributing to growth trajectory
New products contributing to growth trajectory Signatera and Altera Prospera and Renasight unit volumes unit volumes 45,000 80,000 >76,000 >42,000 40,000 70,000 35,000 60,000 30,000 50,000 25,000 40,000 20,000 30,000 15,000 18,000 11,000 20,000 10,000 10,000 5,000 3,000 400 0 0 2019 2020 2021 2019 2
Slide 7: Rapid NIPT adoption, opportunity to help even more patients
Rapid NIPT adoption, opportunity to help even more patients Broad prenatal offering Est. U.S. NIPT Volume1 > 4,400 (thousands) Panorama NIPT: • Robust validation in largest prospective NIPT trial • Expanded share in 2021 even as market grew rapidly ~1,750 • ACOG guideline in place Panorama 22Q delet
Slide 8: Landmark SMART study published in AJOG
Landmark SMART study published in AJOG SMART publication Key results Only 22q test validated in real-world, multi-site prospective study: • Robust validation with confirmed outcomes in >18,000 patients 22q results exceeded expectations: • High incidence 1/1,524, excellent sensitivity and specificity
Slide 9: Transplant: Significant opportunity to help patients
Transplant: Significant opportunity to help patients Tests per year ~1.2M >1M tests per year Heart, lung, other < 10% of transplant Kidney recipients tested today Total < 10% Source: Internal estimates 9 Not for reproduction or further distribution.
Slide 10: Large clinical studies planned for 1H 2022 publication
Large clinical studies planned for 1H 2022 publication Prospera Kidney Prospera Heart Prospera Lung with Quantification Trifecta Study1 Multi-Site Validation Trial2 VALID Study3 • Largest prospective, fully • Includes >250 prospectively • Largest prospective study biopsy-matched, and multi-site coll
Slide 11: Expanding Oncology TAM opportunity
Expanding Oncology TAM opportunity ctDNA / liquid biopsy Early detection Monitoring/MRD Therapy selection $30B $15B $6B Source: Internal estimates 11 Not for reproduction or further distribution.
Slide 12: Signatera staged for efficiency and growth
Signatera staged for efficiency and growth • Commercial footprint built – ready for future growth, currently Commercial Reach at only 10% capacity • Median turnaround time 19 days for first test including Robust Operations tumor exome; 6 days for subsequent tests • Online portals and EMR integration
Slide 13: Circulate-IDEA Japan: Largest prospective MRD study
Circulate-IDEA Japan: Largest prospective MRD study 2021: ASCO, ESMO IO 2022: ASCO-GI • ~1200 patients enrolled • ~3000 patients enrolled • ~800 patients analyzed • ~1000 patients analyzed • Disease free survival stratified • Disease free-survival stratified by MRD by MRD status: status and by treat
Slide 14: MRD-positive patients benefit significantly from ACT
MRD-positive patients benefit significantly from ACT DFS in post-op-4w MRD-positive population % High-risk pStage II % pStage III % pStage IV 100 100 100 W/ ACT 80 80 80 W/O ACT 60 60 60 DFS 40 40 40 20 20 20 Adjusted HR = 9.4 Adjusted HR = 8.8 Adjusted HR = 2.4 0 95% CI, 1.1 to 79.1, P=0.04 0 95% C
Slide 15: No significant treatment benefit for MRD-negative patients
No significant treatment benefit for MRD-negative patients DFS in post-op-4w MRD-negative population (High risk stage II-III) % 100 W/ ACT W/O ACT 80 60 DFS 40 ctDNA Events/N 6M-DFS (95%CI) 12M-DFS (95%CI) W/ ACT 7/214 98.6% (95.7-99.5) 96.2% (92.1–98.2) Adjusted HR = 1.3 20 W/O ACT 12/317 97.5% (95
Slide 16: Circulate Japan ASCO GI 22 key takeaways
Circulate Japan ASCO GI 22 key takeaways Prognostic results Predictive results Circulate Japan ASCO GI 221 • Signatera-positive post surgery: benefit significantly from adjuvant chemo 12M-DFS for MRD-positives 55.5% (HR 8.8-9.4 in high-risk Stage II or III) • Signatera-negative post surgery: 12M-DFS
Slide 17: Significant unmet need served by one technology platform
Significant unmet need served by one technology platform and one commercial team Short term eligible population Mid term population Published/presented indications Studies underway ~13M 12 Tests per year (M) 9 6 ~4.5M 3 0 Total Total *Esophageal, pancreatic, anal cancers Source: Internal estimates 1
Slide 18: Signatera coverage roadmap
Signatera coverage roadmap 2020 – 2021 2022 – 2023 goals 2024 onward • Colorectal, stages II-IV • NCCN guidelines in CRC • Readouts from definitive, • Immunotherapy response • Coverage for 5+ additional phase 3 studies monitoring, pan-cancer cancer types • Pan-cancer coverage • ADLT status from CMS
Slide 19: FY21 financial overview
FY21 financial overview ($ in millions, except for per share data) P&L FY21 FY20 Change Product revenues $567.1 $367.2 $199.9 Licensing and other revenues $58.3 $23.8 $34.5 Total revenues $625.5 $391.0 $234.5 Gross margin%1 49.1% 47.9% 117 bps R&D $264.2 $100.0 $164.2 SG&A $511.0 $303.6 $207.4 Net l
Slide 20: 2022 annual guidance
2022 annual guidance Guide $ (millions) Key drivers Continued volume growth, conservative ASPs, growing contribution from Revenue $770 - $790 new products Gross margin Conservative ASP assumptions, rapid growth in pan-cancer Signatera, new 46% – 48% % revenue patients getting the upfront exome SG&A
Slide 21: Not for reproduction or further distribution.
©2020 Natera, ©2022 Inc.Inc. Natera, All Rights Reserved. All Rights NotNot Reserved. for reproduction or further for reproduction distribution. or further distribution. 21 Not for reproduction or further distribution.