Company Overview - Natera (NTRA) has submitted a premarket approval (PMA) application to the FDA for its Signatera CDx test, a personalized molecular residual disease (MRD) assay for muscle-invasive bladder cancer (MIBC) [1][6] - The PMA submission is a significant regulatory milestone for Natera, positioning Signatera CDx as a companion diagnostic to guide adjuvant immunotherapy decisions in MIBC [6][8] Clinical Data and Implications - The application is supported by positive phase 3 IMvigor011 trial data, which demonstrated improved survival outcomes in MRD-positive patients treated with Tecentriq, while MRD-negative patients showed a low risk of recurrence without additional therapy [2][9] - The trial results were strong enough to be featured in a Presidential Symposium at the ESMO Congress and published in The New England Journal of Medicine, enhancing credibility within the oncology community [10] Market Position and Growth Potential - If approved, Signatera CDx could serve as a long-term growth catalyst for Natera by expanding its MRD platform's role from monitoring to treatment decision-making [4][11] - The companion diagnostic status is expected to increase adoption among oncologists, strengthen partnerships with pharmaceutical companies, and support broader reimbursement coverage, leading to higher testing volumes and more sustainable revenue streams [4][11] Financial Performance - Natera's stock has surged 69.2% over the past six months, significantly outperforming the industry growth of 18.1% and the S&P 500's rise of 12.4% [3] - The current market capitalization of Natera stands at $31.97 billion [5] Industry Outlook - The global precision oncology market is projected to grow from an estimated $115.80 billion in 2024 to $201.96 billion by 2030, with a compound annual growth rate (CAGR) of 8.05% from 2025 to 2030 [12] - Growth in the market is driven by technological advancements, increasing demand for diagnostic solutions that provide clinically actionable insights, and the ability to reduce treatment-related side effects for cancer patients [13]

Summary of Natera's Conference Call Company Overview - **Company**: Natera - **Industry**: Life Sciences, Diagnostics, Oncology, Women's Health - **Core Mission**: Transforming disease management globally through proprietary technology that detects small quantities of DNA [2][3] Key Products and Market Position - **Panorama**: A cell-free fetal DNA test for chromosomal abnormalities, leading with over 50% market share [2] - **Prospera**: A test for organ transplant rejection using donor-derived cell-free DNA [2] - **Signatera**: A circulating tumor DNA test for minimal residual disease (MRD) monitoring, achieving record growth with 22,000 clinical MRD tests in Q4 [3][4] Financial Performance - **Q4 2025 Revenue**: $660 million, up 39% year-over-year, driven by strong average selling prices (ASPs) and volume growth [4] - **Free Cash Flow**: Exceeded $100 million for the year [5] - **Unit Sales**: 924,000 units in Q4, with significant growth in oncology and women's health [3][4] Innovations and Future Growth Drivers - **Fetal Focus**: A new 21-gene single-gene NIPT test aimed at severe genetic disorders, filling a gap in clinical care [5][6] - **Signatera Enhancements**: Incorporation of phased variants technology for improved sensitivity, targeting a limit of detection (LOD) down to one part per 10 million [10][11] - **AI Integration**: Development of an augmented MRD score using AI and a foundation model to enhance precision in risk assessment [12][13] Clinical Trials and Partnerships - **Clinical Trials**: Significant investments in clinical trials, particularly in breast cancer, with over $100 million allocated for evidence generation [16][17] - **STELLAR Trial**: A pivotal phase three trial in colorectal cancer, leveraging Signatera for patient enrollment [18][35] - **Partnerships**: Collaborations with NVIDIA for AI initiatives and Ultima Genomics for new product launches [22] Market Dynamics and Competitive Landscape - **Market Share**: Natera holds over 50% market share in women's health and is focused on maintaining and expanding its position through innovation and clinical evidence [25][39] - **Lymphoma Market**: Interest in expanding into lymphoma and hematologic cancers, leveraging Foresight Diagnostics' technology [27][28] Regulatory and Reimbursement Strategies - **Medicare Coverage**: Ongoing efforts to expand Multi-X coverage, with 30% of tests currently not covered under Medicare [21] - **Reimbursement Process**: Coordination with MolDX for new assay coverage, emphasizing the importance of generating data [32] Future Outlook - **2026 Goals**: Plans to complete enrollment for the FIND study in early cancer detection and launch new products incorporating advanced technologies [21][22] - **Operating Margins**: Expectation of growing into profitability as revenue matures, with a focus on maintaining operational efficiency [46][48] Conclusion Natera is positioned for significant growth through innovative product offerings, strategic partnerships, and a strong focus on clinical evidence generation. The company aims to leverage its market leadership in diagnostics to expand into new therapeutic areas while enhancing its existing product lines.

Natera, Inc. Investor presentation J.P. Morgan Healthcare Conference January 13, 2026 1 Safe harbor statement This presentation containsforward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. Allstatements other than statements of historical facts contained in this presentation, including statements regarding our market opportunity, our anticipated products and launch schedules, our reimbursement coverage and our product costs, our commercial and strategic partn ...

Core Insights - Natera (NTRA) has partnered with NVIDIA (NVDA) to accelerate the development of a multimodal AI foundation model platform aimed at enhancing precision care [1][7] - The collaboration will leverage Natera's extensive longitudinal datasets and machine learning models alongside NVIDIA's advanced computing technology to improve medical data analysis [2][3] Company Developments - The partnership aims to create advanced computational systems for training large-scale AI models, which will facilitate more accurate diagnoses and personalized treatment decisions [2][5] - Natera's AI solutions utilize one of the largest cancer datasets globally, with its NeoSelect system outperforming 25 existing neoantigen prediction methods [8] - The collaboration is expected to enhance Natera's competitive advantage by improving its AI and data capabilities, leading to new revenue streams and stronger relationships with biopharma partners [5] Financial Performance - Following the announcement of the collaboration, Natera's stock increased by 0.5%, with a notable 48.9% rise over the past six months, significantly outperforming the industry and S&P 500 [4] Industry Outlook - The AI in oncology market is projected to reach $2.40 billion by 2026, with a compound annual growth rate (CAGR) of 27.6% through 2035, driven by technological advancements and increasing cancer cases [11]

Financial Data and Key Metrics Changes - The company generated $592 million in revenue for Q3 2025, representing a 35% increase compared to Q3 2024 [6][14] - Gross margins improved to 64.9%, nearly 1.5 percentage points higher than the previous quarter and almost 3 percentage points higher than Q3 of last year [7][15] - The company raised its revenue guidance for 2025 by $160 million, now expecting revenues between $2.18 billion and $2.26 billion [8][41] - Free cash flow generation guidance was increased to approximately $100 million for the full year [10][41] Business Line Data and Key Metrics Changes - The company processed 202,000 clinical MRD tests in Q3, with a growth of over 21,500 units compared to Q2 [7][12] - Signatera ASPs reached approximately $1,200, with significant growth in cash collections and a record for days sales outstanding (DSOs) at 49 days [14][15] - Women's health and organ health segments showed strong performance, contributing to overall revenue growth [11][14] Market Data and Key Metrics Changes - The company reported a 56% year-on-year growth in clinical MRD unit growth, marking the fastest growth rate in 2023 [12] - The adoption of Signatera is being fueled by positive clinical data and strong customer experiences, with a broad mix of tumor types being treated [13][30] Company Strategy and Development Direction - The company plans to submit seven new MolDX submissions by the end of the year, potentially worth $250 million to $300 million in gross profit [9][18] - Investments are being made to expand the market through clinical trials and to support FDA-enabling studies for early cancer detection [10][19] - The company aims to maintain limited OPEX growth of around 10% while revenues are expected to grow significantly faster [19][45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in revenue and volume growth, particularly in oncology and women's health [6][10] - The company anticipates that the recent clinical data will enhance adoption rates for Signatera among oncologists [26][30] - Management highlighted the importance of ongoing investments in R&D and clinical trials to sustain growth and innovation [17][19] Other Important Information - The Fetal Focus product was expanded to cover over 20 genes, with positive initial feedback from the medical community [11][22] - The company is leveraging AI to enhance operational efficiency and scale without a proportional increase in headcount [16][19] Q&A Session Summary Question: Why is now the right time for the new Fetal Focus test? - The five-gene panel received great feedback, and R&D is ready to launch the broader panel as part of the plan [48] Question: How is the path to NCC guidelines being shaped by recent clinical utility data? - The InVigor 011 data is expected to be included in NCCN guidelines, with updates anticipated mid to late next year [54] Question: How important was the PRECEDE-CRC advanced adenoma performance in shaping investment decisions? - The performance achieved influenced the decision to invest further in the program, with strong results prompting the initiation of the FIND study [58][60] Question: Can you provide insights on the contribution from new patient starts for Signatera? - New patient starts in Q3 were at record levels, similar to Q2, indicating strong ongoing interest and adoption [85]

Financial Data and Key Metrics Changes - The company generated $592 million in revenue for Q3 2025, representing a 35% increase compared to Q3 2024 [6][14] - Gross margins improved to 64.9%, nearly 1.5 percentage points higher than the previous quarter and almost 3 percentage points higher than Q3 of last year [7][15] - The revenue guidance for 2025 has been raised by $160 million, now expected to be in the range of $2.18 billion to $2.26 billion [8][41] - Free cash flow generation guidance has been significantly increased, with expectations to generate roughly $100 million for the full year [10][41] Business Line Data and Key Metrics Changes - The company processed 202,000 clinical MRD tests in Q3, marking an increase of over 21,500 units compared to Q2 [7][12] - Signatera ASPs reached approximately $1,200, with strong performance across all major products [14][15] - Women's health and organ health segments showed solid sequential growth, driven by the launch of the Fetal Focus test and ongoing clinical trials [11][12] Market Data and Key Metrics Changes - The clinical MRD unit growth represented a 56% year-on-year increase compared to Q3 of last year, with significant contributions from Signatera [12][14] - The company is seeing broad adoption of Signatera across various tumor types, which is expected to create substantial revenue opportunities [13][32] Company Strategy and Development Direction - The company plans to submit seven new MolDX submissions by the end of the year, potentially worth $250 million to $300 million in gross profit [9][18] - Investments are being made to expand the market and support FDA-enabling studies for early cancer detection [10][20] - The company aims to maintain limited OPEX growth of approximately 10% while revenues are expected to grow significantly [19][45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in clinical data and customer experience driving adoption of their tests [12][13] - The company anticipates that the IMvigor011 trial results will positively influence the adoption of Signatera among GU oncologists [26][27] - Management expects to see continued growth in cash flow generation and operational scale in the coming years [41][45] Other Important Information - The Fetal Focus test has been expanded to cover over 20 genes, with positive initial feedback from the medical community [10][11] - The company is leveraging AI to enhance operational efficiency and scale without a proportional increase in headcount [16][19] Q&A Session Summary Question: Why is now the right time for the new Fetal Focus test? - The five-gene panel launched earlier received great feedback, and R&D is now ready for the broader panel launch, which was part of the original plan [48] Question: How is the path to NCC guidelines being shaped by recent data? - The IMvigor011 data is level 1A clinical data and has been submitted for FDA approval, which typically leads to inclusion in NCCN guidelines [50][54] Question: How important was the PROCEED-CRC advanced adenoma sensitivity performance? - The performance achieved has significantly shaped the company's willingness to invest further in the program [57][59] Question: Can you provide details on the contribution from new patient starts for Signatera? - New patient starts in Q3 were at record levels, similar to the previous quarter, indicating strong ongoing interest [85][86]

Financial Data and Key Metrics Changes - The company generated $592 million in revenue for Q3 2025, representing a 35% increase compared to Q3 2024 [5] - Gross margins improved to 64.9%, nearly 1.5 percentage points higher than the previous quarter [5] - The revenue guidance for 2025 has been raised by $160 million, now expecting revenues between $2.18 billion and $2.26 billion [6][37] Business Line Data and Key Metrics Changes - Clinical MRD tests processed reached 202,000, with a growth of over 21,500 units compared to Q2 2025 [5] - Signatera ASPs are now approximately $1,200, with significant growth in cash collections and a record for days sales outstanding (DSOs) at 49 days [12][36] - Women's health and organ health segments showed strong performance, contributing to overall revenue growth [12] Market Data and Key Metrics Changes - The company reported a 56% year-on-year growth in clinical MRD unit growth, marking the fastest growth rate in 2023 [10] - The adoption of Signatera is broadening across various tumor types, indicating a significant revenue opportunity as reimbursement expands [11][15] Company Strategy and Development Direction - The company plans to submit seven new MolDX submissions by the end of the year, potentially worth $250 million to $300 million in gross profit [7] - Investments are being made to expand the market and support FDA-enabling studies for early cancer detection [8][19] - The company is focusing on maintaining a stable SG&A while investing in R&D to support new product launches and clinical trials [18][40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in revenue and volume growth, expecting continued strong performance into Q4 2025 [5][10] - The company anticipates limited OPEX growth of around 10% while revenues are expected to grow at a faster rate [18][40] - Management highlighted the importance of clinical data and customer experience in driving adoption of their products [11][27] Other Important Information - The company launched Fetal Focus, a new single-gene NIPT for inherited conditions, expanding its panel to cover over 20 genes [9][20] - The results from the Invigor-011 trial in bladder cancer were highlighted as a significant advancement for Signatera, with implications for treatment decisions [24][30] Q&A Session Summary Question: Why is now the right time for the new Fetal Focus test? - The five-gene panel received positive feedback, and R&D has progressed to launch a broader panel, which was part of the initial plan [42] Question: How does the InVigor data impact NCC guidelines and commercial payer adoption? - The InVigor 011 data is level 1A clinical data and has been submitted for FDA approval, with expectations for inclusion in NCCN guidelines [44] Question: How important was the PRECEDE-CRC advanced adenoma performance in shaping investment decisions? - The performance achieved influenced the decision to invest further in the FIND study, with strong confidence in the roadmap of improvements [46] Question: Can you provide insights on Signatera's growth and new patient starts? - New patient starts in Q3 were at record levels, with significant growth across various tumor types, indicating a strong market position [50][61]

Financial Performance - Q3 2025 revenue reached approximately $592 million, a year-over-year increase of about 35% compared to approximately $440 million in Q3 2024[8] - Approximately 894,000 total tests were processed in Q3 2025, reflecting a year-over-year growth of about 15% from approximately 776,000 in Q3 2024[8] - Clinical MRD tests numbered approximately 202,000 in Q3 2025, a year-over-year increase of about 56% from approximately 130,000 in Q3 2024[8] - Gross margin was approximately 65% in Q3 2025, with approximately $26 million in cash inflow generated[8] - The 2025 financial outlook was increased by $160 million, projecting revenue between $218 billion and $226 billion, gross margin between 62% and 64%, and $100 million in cash flow generation[8] Product Development and Data - A newly expanded 20-gene panel for Fetal Focus is launching in Q4[29] - Early cancer detection data for advanced adenomas was announced[8] - Strong Signatera data was presented at ESMO, reinforcing MRD leadership[8] Clinical Data and Studies - ESMO Congress presented practice-changing evidence in muscle-invasive bladder cancer[33] - Strong Signatera data in colorectal cancer was presented at ESMO, with a publication in Nature[36] - Overall advanced adenoma performance showed 225% sensitivity (CI: 154%-324%) and 915% specificity (CI: 882%-939%)[44]

Financial Data and Key Metrics Changes - The company generated $547 million in revenue, representing a 32% growth over Q2 of the previous year, and a 34% growth when excluding revenue true-ups [6][8] - Gross margin increased to 63.4% compared to approximately 59% in the same quarter last year, with consistent margins sequentially versus Q1 [7][14] - The revenue guidance for the year has been raised by $80 million, now expecting revenues in the range of $2.1 billion to $2.2 billion [8][56] Business Line Data and Key Metrics Changes - The company processed 189,000 oncology tests in the quarter, marking a growth of nearly 20,000 units compared to Q1, setting a new milestone [7][11] - Significant growth was noted in the Signatera product line, with new patient starts doubling the previous quarterly record [7][12] - Women's health products had their second-best volume quarter ever, despite seasonal trends [10] Market Data and Key Metrics Changes - The company is seeking Medicare reimbursement for additional tumor types, which could yield approximately $250 million to $300 million in annual revenue [13] - The company reported a record low in Days Sales Outstanding (DSOs) at 57 days, indicating improved cash collection efficiency [15] Company Strategy and Development Direction - The company is focused on expanding its product offerings, including the launch of Fetal Focus, a new NIPT for inherited conditions [9][26] - Investments are being made in artificial intelligence to enhance diagnostic capabilities and operational efficiency [25][46] - The company aims to maintain operating expenses while increasing revenue, indicating a strategy of scaling without proportional increases in costs [20][58] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, citing strong data and increased adoption of products [6][8] - The company is positioned to leverage its existing infrastructure to expand its market presence and improve patient outcomes [75] - Management highlighted the importance of upcoming clinical trial readouts, which could significantly impact practice guidelines [66][68] Other Important Information - The company exited its legacy paternity business, which had previously contributed to volume numbers [10] - The PEDAL study published in a high-impact journal demonstrates the potential of donor-derived cfDNA in predicting kidney transplant outcomes [30][31] Q&A Session Summary Question: What drove the record Signatera volumes? - Management noted strong data presentations at ASCO and significant growth in new patient starts, indicating a broad adoption of the product across various tumor types [61][63] Question: What are the key upcoming clinical trials? - Management highlighted the INVIGOR-11 trial and several colorectal trials that could influence guidelines and practice [66][68] Question: How is the company addressing the competitive landscape in early cancer detection? - Management emphasized their in-house R&D capabilities and the alignment of their PROCEED trial with FDA protocols, aiming for a strong performance readout [79][80]

Financial Data and Key Metrics Changes - The company generated $547 million in revenue, representing a 32% growth year-over-year, and a 34% growth when excluding revenue true-ups [5][6] - Gross margin increased to 63.4% compared to approximately 59% in the same quarter last year [6][15] - The company raised its revenue guidance by $80 million, now expecting revenues in the range of $2.1 billion to $2.2 billion [7][58] Business Line Data and Key Metrics Changes - The company processed 189,000 oncology tests in the quarter, marking a sequential growth of 20,000 units, which is a new milestone [6][11] - Signatera saw record growth in both sequential growth and new patient starts, with new patient starts being double the previous quarterly record [6][12] - Women's health products had the second-best volume quarter ever, following a strong Q1 [10] Market Data and Key Metrics Changes - The company is seeking Medicare reimbursement for additional tumor types, which could represent an annual revenue opportunity of $250 million to $300 million [13] - The company reported a significant increase in cash collections, with days sales outstanding (DSOs) down to 57 days, a record low [16] Company Strategy and Development Direction - The company is focused on launching new products, including Fetal Focus, a new NIPT for inherited conditions, and expanding its oncology data pipeline [8][30] - Investments are being made in artificial intelligence to develop new diagnostic biomarkers and improve operational efficiencies [19][47] - The company aims to maintain operating expenses while increasing revenue, indicating a strategy of scaling without proportional increases in costs [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, citing strong data and new patient starts as key drivers [6][12] - The company is committed to maintaining cash flow positivity while investing in growth opportunities [60] - Management highlighted the importance of upcoming clinical trial readouts and their potential impact on market positioning [70][81] Other Important Information - The company exited its legacy paternity business, which had historically contributed to volume numbers [10] - The PEDAL study published in a high-impact journal demonstrated the utility of donor-derived cfDNA in predicting long-term outcomes after kidney transplant rejection [30][31] Q&A Session Summary Question: What drove the record Signatera volumes? - Management noted strong data presentations at ASCO and significant growth in colorectal and breast cancer monitoring as key drivers, along with a record increase in new patient starts [62][63] Question: What are the important upcoming clinical trials? - Management highlighted the INVIGOR-11 trial and several colorectal trials that could influence guidelines and practice [66][70] Question: How is the company addressing the competitive landscape in early cancer detection? - Management emphasized their in-house R&D capabilities and the alignment of their PROCEED trial with FDA protocols as a strategic advantage [80][81]