医药生物 G [Table_ReportDate] 2025 年 08 月 25 日 [Table_Author] 分析师：王俐媛 执业证书号：S1030524080001 电话：0755-83199599 邮箱：wangly1@csco.com.cn 研究助理：徐伊琳 电话：0755-23602217 邮箱：xuyl@csco.com.cn 公司具备证券投资咨询业务资格 证券研究报告 MRD 有望成为新的免疫伴随诊断 [Table_ReportType] 医药生物行业周报（8 月第 4 周） [Table_S 行业ummary 观点：] 请务必阅读文后重要声明及免责条款 [Table_Industry] [Table_BaseData] 1) 周度回顾。上周（8 月 18 日-8 月 22 日）医药生物板 块收涨 1.05%，跑输 Wind 全 A（3.87%）和沪深 300 （4.18%）。从板块来看，医疗设备（4.49%）、疫苗 （4.41%）和中药（2.86%）涨幅居前，医疗研发外包 （-3%）、原料药（-1.44%）和医疗耗材（-0.01%）跌幅 居前。从个股来看，香雪制药（40.4%）、欧林生物 ...

Natera (NTRA) FY Conference August 12, 2025 02:00 PM ET Company ParticipantsMike Brophy - CFOConference Call ParticipantsKyle Mikson - Managing Director & Senior Research AnalystKyle MiksonI'm Kyle Mixon. I cover life science tools and diagnostics for Canaccord. Please welcome me to a fireside chat with Natera here with us today. Natera is a leader in cell free DNA based testing for women's health oncology and organ health. With us from the company we have Mike Brophy, CFO.Thanks Thanks Mike for joining us. ...

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]

Natera, Inc. Q2'2025 Earnings Presentation 2 Q2 2025 highlights and recent business updates August 7, 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 commercia ...

Company Overview - Natera is a genetic testing company specializing in detecting tiny quantities of DNA across healthcare areas [3] - The company has a market cap of approximately $22 billion [2] - Natera has processed 12 million tests so far [11] Technology and Products - Natera's technology can detect cancer recurrence up to two years in advance of imaging [4][8] - The company utilizes a unique test called Signatera, specialized for each patient, to detect circulating tumor DNA [5][7] - The test sequences the entire tumor and compares it to the patient's germline DNA to identify unique signatures [7][9] Market and Financials - Natera operates in a total addressable market estimated at $50 billion [12] - The MRD (Minimal Residual Disease) segment, including Signatera, represents a $20 billion market [12] - The company follows standard billing and reimbursement guidelines and is in-network with most insurance plans [10][11]

Financial Data and Key Metrics Changes - The company achieved over $500 million in revenue for the first time, marking a significant milestone [7] - Gross margins improved by more than 100 basis points sequentially from Q4 [8] - The company generated substantial cash flow in Q1, reaffirming its goal to be cash flow breakeven for the year [38][39] Business Line Data and Key Metrics Changes - Signatera saw record growth with approximately 165,000 units in Q1, indicating a strong annualized potential of around 720,000 units [15] - The women's health business experienced high single-digit growth sequentially from Q4, benefiting from market consolidation and increased volume from competing labs exiting the space [5][30] - Oregon Health reported over 50% year-on-year growth within its franchise [6] Market Data and Key Metrics Changes - The NIPT market is maturing, with Natera capturing significant volume from competitors that have exited the market [5][30] - The company noted a shift in the mix of Signatera volumes, with expectations for a gradual increase in recurrence monitoring as more patients remain on the test over time [21][22] Company Strategy and Development Direction - The core growth driver for Signatera is the unmet clinical need for MRD testing, with a focus on delivering high-quality prospective outcomes data [14][16] - The company plans to launch a tumor-naive MRD test to address a segment of patients who are not suitable for tumor-informed tests [19] - Natera is targeting a launch in Japan by 2027, with expectations for rapid adoption due to the prevalence of colorectal cancer and existing guidelines for MRD usage [28][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of Signatera despite increased competition, emphasizing the importance of solving clinical problems for patients [56][59] - The company is committed to investing in R&D and commercial operations to maintain its competitive edge and address the unmet needs in the MRD market [37][50] Other Important Information - The company highlighted the importance of customer service and innovation in driving growth within the women's health segment [34][36] - Management noted that the competitive landscape is evolving, with established companies entering the MRD market, but they view this as an opportunity for overall improvement in patient outcomes [56][58] Q&A Session Summary Question: What are the main growth drivers for Signatera? - The main growth driver is the clinical problem of MRD, with significant room for adoption as efficacy data continues to support its use [14][15] Question: How is the mix between adjuvant and recurring volumes changing? - The mix has historically been balanced, but there is an expectation for a shift towards more recurring volumes as patients continue monitoring over time [21][22] Question: What is driving the momentum towards achieving an ASP of $2,000 for Signatera? - The momentum is driven by improving reimbursement rates among Medicare Advantage patients and potential launches in new markets like Japan [23][24][28] Question: How does the company view competition in the MRD market? - Competition is seen as a positive force that can lead to better solutions for patients, and the company is focused on addressing clinical needs rather than solely defending market share [56][59] Question: What is the strategy for R&D investments moving forward? - The company plans to increase R&D investments, particularly in generating evidence for MRD and recurrence monitoring, while also exploring partnerships for clinical trials [46][50]

Company Overview - Natera is a genetic testing company focusing on oncology, women's health, and organ health [1] - The company's signature product, Signatera, is designed to predict the efficacy of various cancer treatments [1] Investment Insights - The author emphasizes the importance of studying earnings reports to identify potential investment opportunities, highlighting a successful investment strategy during the pandemic [1] - The author mentions identifying future winners such as OPRX, OTRK, FUBO, and PLUG through careful analysis of earnings transcripts and reports [1]

Financial Data and Key Metrics Changes - The company generated $520 million in revenue for Q1 2025, representing approximately 37% growth compared to $368 million in Q1 2024 [7][32] - Gross margins improved to 63% in Q1 2025, up from 52% a year ago, with underlying gross margin improvement of about 110 basis points from Q4 2024 [8][33] - The company generated $23 million in cash during the quarter while increasing investments in growth [8][20] Business Line Data and Key Metrics Changes - Women's Health volumes increased significantly, with over 40,000 units processed sequentially in Q1 2025 compared to Q4 2024 [14][81] - Organ Health saw over 50% year-on-year growth, driven by interest in donor-derived cell-free DNA tests [14] - Signatera clinical volumes grew 52% year-on-year, with a record increase of approximately 16,500 units compared to Q4 2024 [8][15] Market Data and Key Metrics Changes - The company processed 855,000 tests in Q1 2025, an 8% sequential increase over Q4 2024 [13] - The oncology segment is seeing significant growth, with over 45% of oncologists in the U.S. ordering Signatera tests last quarter [16] - The company expects revenues for the full year to be in the range of $1.94 billion to $2.02 billion, reflecting a $70 million increase from prior guidance [9] Company Strategy and Development Direction - The company is focused on expanding clinical utility and innovating to help more patients, particularly in oncology [16][21] - There is a strategic emphasis on increasing average selling prices (ASPs) through improved reimbursement operations and expanding into new tumor types [18][20] - The company aims to achieve gross margins above 70% over time, with significant potential opportunities identified [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of volume growth and ASP improvements, despite potential short-term headwinds from new product launches [35][36] - The company views 2025 as a crucial investment year, particularly for Signatera, with expectations of continued strong cash flow generation [20][37] - Management highlighted the importance of upcoming clinical data presentations at major conferences, which are expected to drive further growth [25][29] Other Important Information - The company has maintained a strong balance sheet with nearly $1 billion in cash and no debt outside of a line of credit [33] - The DEFINE study in heart transplantation demonstrated Prospera's ability to predict clinical outcomes, outperforming traditional biopsy methods [10][22] - The company is preparing for significant data presentations at ASCO, with nearly 30 abstracts planned across multiple tumor types [28][29] Q&A Session Summary Question: What drove the sequential volume growth in Signatera? - Management noted that strong clinical utility and data performance resonated with physicians, contributing to record growth [42] Question: Which clinical studies should be focused on for potential market impact? - Management highlighted the I SPY two trial and the DARE study as significant upcoming studies that could influence market volumes [45][46] Question: Were there any disruptions in Q1 due to weather or calendar dynamics? - Management acknowledged weather challenges but indicated that patient demand for tests remained strong, minimizing impact on volumes [54][56] Question: What is the outlook for ASPs and reimbursement? - Management expects stable ASPs in women's and organ health, with modest improvements in Signatera driven by increased Medicare Advantage coverage [74] Question: Can you provide an update on the colorectal screening front? - Management confirmed that the PRESIDE study has met its enrollment goals and will report results by the end of the year, with an FDA enabling study also underway [67][68]

Financial Data and Key Metrics Changes - The company generated $520 million in revenue for Q1 2025, representing approximately 37% growth compared to $368 million in Q1 2024 [5][6][14] - Gross margins improved to 63% in Q1 2025, up from 39% in previous quarters, with an underlying gross margin improvement of about 110 basis points from 59.3% in Q4 2024 to 60.4% in Q1 2025 [15][16][30] - The company generated $23 million in cash during the quarter, indicating strong cash flow generation despite increased investments in growth [6][17][30] Business Line Data and Key Metrics Changes - Women's Health volumes grew significantly, with over 40,000 units processed sequentially in Q1 2025, continuing strong growth from 2024 [12][30] - Organ Health saw over 50% year-on-year growth, driven by interest in donor-derived cell-free DNA and germline tests [12][30] - Signatera clinical volumes grew 52% year-on-year, with a record increase of approximately 16,500 units compared to Q4 2024 [6][13][14] Market Data and Key Metrics Changes - The company processed 855,000 tests in Q1 2025, an 8% sequential increase over Q4 2024 [11][12] - The oncology market is expanding, with over 45% of oncologists in the U.S. ordering Signatera tests last quarter [13][14] - The company anticipates that Signatera could eventually generate more than $5 billion in annual revenue, reflecting significant market potential [17][30] Company Strategy and Development Direction - The company is focused on expanding clinical utility and innovating to help more patients, particularly in oncology and women's health [13][17] - The company plans to continue funding high return on invested capital (ROIC) investments in commercial operations, clinical trials, and product improvements [17][30] - The company aims to achieve gross margins above 70% over time, with ongoing improvements in average selling prices (ASPs) and cost of goods sold (COGS) [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of revenue growth, driven by strong clinical utility and data generated from studies [41][42] - The company is optimistic about upcoming data presentations at major conferences, which are expected to enhance market presence and drive future growth [43][44] - Management highlighted the importance of maintaining cash flow breakeven while investing in growth opportunities, particularly in oncology [30][34] Other Important Information - The company raised its revenue guidance for 2025 to a range of $1.94 billion to $2.02 billion, reflecting a $70 million increase from previous guidance [7][31] - The company is preparing for significant data presentations at ASCO and ESMO conferences, with nearly 30 abstracts planned [25][26] - The company is also pursuing expansion into new histologies, including sarcoma, which presents a significant clinical unmet need [24][25] Q&A Session Summary Question: What drove the sequential volume growth in Signatera? - Management noted that strong clinical utility and a large commercial presence contributed to the record sequential growth, with expectations for continued utilization [40][41] Question: Which clinical studies should be focused on for potential volume growth? - Management highlighted the I SPY two trial and the DARE study as significant upcoming studies that could impact volumes positively [42][43] Question: Did weather or calendar dynamics affect Q1 performance? - Management acknowledged that weather challenges existed but did not significantly impact volumes, as patients still sought necessary tests [54][56] Question: What is the outlook for ASPs and reimbursement? - Management indicated stable ASPs in women's health and organ health, with modest improvements expected in Signatera due to increased reimbursement rates [71][75] Question: What is the status of the colorectal screening study? - Management confirmed that the PRESIDE study has met its enrollment goals and results are expected by the end of the year [67][68]