Question-and-Answer SessionMaybe to kick it off, could we just do a quick look back at 3Q record clinical MRD volumes. Talk a little bit about some of the momentum you saw coming out of the quarter.Steve ChapmanCEO & Director Yes. Thanks, Tycho. So we had a great quarter across the board in all product areas, but particularly in Signatera, where we saw record growth from a net unit standpoint quarter-on-quarter versus Q2. And that very strong momentum has sort of continued into the beginning part of Q4, as ...

Natera FY Conference Summary Company Overview - Natera is a leading diagnostic company specializing in cell-free DNA technology, particularly in prenatal testing and minimal residual disease (MRD) testing [3][5] Financial Performance - Q3 results showed a revenue beat of $25 million, leading to an increase in full-year guidance by $160 million, tracking towards 30% growth on a multibillion-dollar base [7][12] - The women's health business has seen outstanding revenue growth due to improved insurance coverage for tests [12] Product Insights - **Signatera**: - The product is becoming a standard in cancer care, with significant adoption among oncologists and patients [8][9] - Long-term growth target for Signatera is projected at $5 billion in annual sales with gross margins approaching 70% [13] - Current revenue in oncology is expected to be around $1 billion, with potential for significant growth [15][16] - **Market Penetration**: - Colorectal cancer represents a significant opportunity, with an estimated annual testing volume of 1.25 million tests in the U.S. [20][22] - Current utilization is low, with only 400,000 units run-rated against the potential market [23] - **International Expansion**: - Plans to launch in Japan in 2027, which could double the annual volume opportunity [24][26] Competitive Landscape - Natera does not claim to own the market but acknowledges the presence of many companies working on similar problems [29] - The company is focused on maintaining a competitive edge through innovation and addressing significant clinical needs [62] Reimbursement and Regulatory Developments - Natera is actively working on MolDX submissions to improve Medicare coverage, which currently affects about 30% of their volume [38][40] - The company is seeing positive effects from biomarker bills in various states, which could enhance reimbursement opportunities [40][42] Future Outlook - Natera is optimistic about achieving cash flow break-even by mid-2024 and expects to generate sustainable cash flow thereafter [18] - The company is committed to investing in R&D and clinical trials to support its growth strategy, particularly in early cancer detection [17][54] Key Challenges - The company faces challenges in ensuring coverage and reimbursement for its tests, particularly in navigating the complexities of Medicare and commercial payers [46][48] - There is a need to balance operational expenditures with growth opportunities while maintaining high-quality R&D [17][19] Conclusion - Natera is positioned for significant growth in the diagnostic space, particularly with its innovative products like Signatera and its expansion into new markets. The company is focused on solving critical healthcare problems while navigating the complexities of reimbursement and competition in the industry [60][64]

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]

Natera, Inc. Post-ESMO Investor Call October 23, 2025 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 anticipated products and launch schedules, our reimbursement coverage and our product costs, our commercial and strategic partnerships and potential acquisitio ...

Core Insights - Roche announced positive results from the phase III IMvigor011 study, demonstrating that Tecentriq (atezolizumab) significantly improves overall survival (OS) and disease-free survival (DFS) in muscle-invasive bladder cancer (MIBC) patients at risk of recurrence after surgery [1][2][5] - The study utilized a ctDNA-guided approach, which reduced unnecessary treatment for low-risk patients, indicating a shift towards personalized cancer treatment [1][2][3] Study Results - Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared to placebo [1][5] - At a median follow-up of 16.1 months, median DFS was 9.9 months in the Tecentriq group versus 4.8 months in the placebo group, with a stratified hazard ratio (HR) of 0.64 [2][3] - Median OS was 32.8 months for Tecentriq compared to 21.1 months for placebo, with an HR of 0.59 [2][3] Study Design - IMvigor011 is a global phase III, randomized, placebo-controlled, double-blind study involving 761 participants, focusing on the efficacy and safety of Tecentriq in ctDNA-positive MIBC patients [3] - The primary endpoint is investigator-assessed DFS, while secondary endpoints include OS and tolerability [3] Treatment Context - Tecentriq is a monoclonal antibody targeting PD-L1, which may reactivate T cells to combat cancer [4][5] - It has been approved for various aggressive cancer types and is available in both subcutaneous and intravenous formulations [5][6] Industry Implications - The results from the IMvigor011 study may advance bladder cancer treatment by integrating precision diagnostics with immunotherapy, potentially leading to more personalized treatment approaches [2][5] - With over 150,000 new MIBC diagnoses annually, the findings could significantly impact treatment strategies and patient outcomes in this aggressive cancer type [2][5]

Core Insights - Natera, Inc. announced results from the phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC) [1] - The findings indicate that Signatera can enhance the adjuvant treatment window and optimize the use of adjuvant atezolizumab (Tecentriq®) in MIBC [1] - The trial results show improvements in disease-free survival (DFS) and overall survival (OS) [1] Company Summary - Natera, Inc. is recognized as a global leader in cell-free DNA and precision medicine [1] - The company is actively involved in advancing treatment options for muscle-invasive bladder cancer through innovative clinical trials [1] Industry Summary - The results from the IMvigor011 trial may influence the treatment landscape for muscle-invasive bladder cancer, particularly in the use of adjuvant therapies [1] - The findings could lead to broader applications of precision medicine in oncology, enhancing patient outcomes [1]

Core Insights - Natera, Inc. is showcasing its technology at the European Society for Medical Oncology (ESMO) Congress, with 14 studies presented, including six oral presentations that emphasize its leadership in molecular residual disease (MRD) testing across various cancer types [1][2]. Bladder Cancer Highlights - The IMvigor011 trial, sponsored by Genentech, will present data on Signatera's predictive capabilities for disease-free survival (DFS) and overall survival (OS) in muscle-invasive bladder cancer (MIBC) [2]. - The CheckMate 274 trial results indicate that DFS for Signatera-positive patients treated with nivolumab was 7.4 months compared to 2.8 months for placebo, with a hazard ratio of 0.35, highlighting the effectiveness of MRD-guided treatment [3]. Additional ESMO Data - Other oral presentations will cover results from the SunRISe-4 trial in MIBC, the INTERCEPT trial in colorectal cancer, and Natera's early cancer detection program, showcasing the breadth of research utilizing Signatera [4]. Expert Commentary - Experts emphasize that Signatera MRD can identify bladder cancer patients likely to benefit from adjuvant immunotherapy, aiming to improve treatment outcomes and change medical practices [5]. Presentation Schedule - A detailed schedule of presentations featuring Natera's technology at ESMO includes various studies on bladder cancer, colorectal cancer, and breast cancer, with specific dates and presenters listed [6][7][8][9][10][11].