NeoGenomics (NasdaqCM:NEO) FY Conference November 19, 2025 02:00 PM ET Company ParticipantsJeff Sherman - CFOWarren Stone - COOTony Zook - CEOConference Call ParticipantsMason Carrico - AnalystMason CarricoAll right. Welcome to day two of the Stephens Conference. I'm Mason Carrico. I'm the diagnostics and medtech analyst here at Stephens. Excited to have NeoGenomics joining us today. We've got Tony Zook, CEO, Jeff Sherman, CFO, and Warren Stone, COO. Thank you, guys, for joining us.Tony ZookThanks for havin ...

Summary of Adaptive Biotechnologies Conference Call Company Overview - **Company**: Adaptive Biotechnologies (NasdaqGS:ADPT) - **Conference Date**: November 19, 2025 Key Points Financial Performance - **3Q Performance**: - Volumes increased by 7% quarter-over-quarter and 32% year-over-year [4] - Average Selling Prices (ASPs) rose to $1,340, with a long-term target of $1,700-$1,800 [4] - Gross margin improved from 63% to 66%, with 2% attributed to NovaSeq implementation [4] - Cash collections increased by 20% from 2Q to 3Q and 85% year-over-year [7] Market Dynamics - **Adoption and Coverage**: - Coverage gap fill rate adjusted to $2,007 per test, indicating confidence in reaching ASP targets [6] - Significant coverage wins from major payers, including Anthem and Blue Cross Blue Shield [7] - Medicaid pricing doubled from $200 to $400 [9] Clinical Guidelines and Utilization - **Guideline Inclusions**: - First-time guideline inclusion for CLL and DLBCL, emphasizing the importance of MRD assessment [11] - Increased recognition of the clinical utility of clonoSEQ in treatment decisions [13] - 90 abstracts and oral presentations planned for ASH, showcasing the clinical utility of MRD assessments [14] Operational Initiatives - **EMR Integration**: - Currently at 40% EMR integrated sites, with a goal to exceed 50% by year-end [26] - EMR integrated sites showed a growth rate of 9% compared to 6% for non-integrated sites [26] Pharma Business - **MRD Backlog**: - Over $200 million in backlog, with a significant increase in CLL bookings due to ODAC standards [29] - 85% of backlog expected to convert to revenue over time, with a structured recognition pattern [32] Future Outlook - **2026 Projections**: - Strong growth anticipated in the MRD business, with low penetration in most indications [43] - Focus on blood-based testing and community hospital settings, where 65% of patients are treated [43] - Immune medicine business viewed as a low-cost option with potential for significant data-driven advancements [44] Additional Insights - **AI and Immunology**: - Investments in AI and machine learning for protein-protein interactions, with applications in drug discovery [37] - Development of a lead T cell depleting antibody for autoimmune disorders, with a focus on patient selection tools [39] Conclusion - Adaptive Biotechnologies is positioned for strong growth in the MRD market, with significant operational improvements and a robust pipeline in both MRD and immune medicine sectors. The company is focused on expanding its market presence through EMR integration and enhancing clinical utility through ongoing research and guideline updates.

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]

Core Insights - Allogene Therapeutics is advancing its allogeneic CAR T therapy portfolio aimed at improving access to cell therapy for cancer and autoimmune diseases, with a focus on earlier treatment and broader application [1][2] Financial Performance - For Q3 2025, the company reported a net loss of $41.4 million, or $0.19 per share, with total operating expenses of $44.9 million [14][19] - As of September 30, 2025, Allogene had $277.1 million in cash, cash equivalents, and investments, projecting a cash runway into the second half of 2027 [10][21] Clinical Trials and Developments - The pivotal Phase 2 ALPHA3 trial with cema-cel is exploring allogeneic CAR T therapy for earlier-line treatment of large B-cell lymphoma (LBCL), with over 50 clinical sites active in the U.S. and Canada, and additional sites expected to open in Australia and South Korea in early 2026 [3][6] - The next milestone for the ALPHA3 trial is a futility analysis expected in the first half of 2026, focusing on minimal residual disease (MRD) conversion rates [4][6] - The Phase 1 RESOLUTION trial with ALLO-329 is investigating a dual CD19/CD70 CAR for autoimmune diseases, with a focus on reducing or eliminating lymphodepletion to improve tolerability [5][7] - ALLO-316 is the only allogeneic CAR T therapy showing significant response rates in metastatic solid tumors, with the TRAVERSE trial in renal cell carcinoma demonstrating early signs of efficacy [8][6] Strategic Vision - The company aims to shift from personalized therapies to off-the-shelf treatments that can be more widely available, enhancing consistency, safety, and quality in cell therapy [2][12] - Allogene's approach leverages ex vivo manufacturing to improve the precision and control of cell products before administration to patients [2][12]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $188 million, representing a year-over-year growth of 12% [11][18] - Clinical revenue increased by 18% year-over-year, while non-clinical revenue declined by 27% [18] - Adjusted EBITDA was $12.2 million, marking the ninth consecutive quarter of positive earnings [21] - Average revenue per clinical test (AUP) increased by 3% year-over-year, with a sequential increase of 4% from Q2 [19][20] Business Line Data and Key Metrics Changes - Clinical business revenue grew by 15% excluding the Pathline acquisition, driven by effective execution of the commercial strategy [11] - NGS revenue grew by 24% year-over-year, accounting for 33% of total clinical revenue year-to-date [19] - Non-clinical revenue accounted for less than 9% of total revenue in Q3, consistent with expectations [12] Market Data and Key Metrics Changes - The therapy selection and MRD markets represent over $40 billion of addressable market opportunity, both growing rapidly [10] - MRD cancer surveillance and monitoring is estimated to be a $30 billion market, growing at a 30% CAGR with less than 10% market penetration [14] Company Strategy and Development Direction - The company is focused on advancing NGS and MRD long-term growth initiatives, including the launch of the RaDaR ST MRD assay [6][10] - The acquisition of Pathline enhances the company's presence in the Northeast, allowing for faster turnaround times and a broader test menu [8] - The company aims to consolidate send-out testing to simplify operational workflows and improve patient experience [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about significant opportunities in cancer testing, particularly in community settings where 80% of cancer care is delivered [7] - The company anticipates continued strong clinical performance and growth in NGS and MRD markets [17] - Full-year consolidated revenue guidance is revised to $720 million-$726 million, representing growth of 9%-10% over 2024 [22][23] Other Important Information - The company received a favorable court ruling regarding the RaDaR ST MRD assay, allowing for broader commercialization [12][13] - Cash flow from operations was positive at $9 million, with total cash at $164 million [21] Q&A Session Summary Question: How comfortable is the company with the guidance and the latest on PanTracer LBx? - Management believes they are in a good position to meet Q4 expectations and confirmed that PanTracer LBx does not need approval from MolDX to meet guidance [26][27] Question: What are the growth drivers expected for 2026? - Growth drivers for 2026 are expected to be similar to 2025, with strong clinical performance and ongoing NGS growth [31] Question: Where is the company seeing the most wins on the customer side for NGS? - Most growth is coming from community oncology practices, with strong performance from the PanTracer family of products [38] Question: What is the expected impact of the LIMS rollout? - The LIMS project is expected to deliver operational efficiencies starting in 2026, with significant benefits in 2027 and beyond [42][44] Question: How is the company addressing the challenges in the pharma business? - The company is focusing on execution excellence and leveraging new products like RaDaR and PanTracer LBx to improve relevance in the pharma space [54][56]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $188 million, representing a year-over-year growth of 12% [11][18] - Clinical revenue increased by 18% year-over-year, while non-clinical revenue declined by 27% [18] - Adjusted EBITDA was $12.2 million, marking the ninth consecutive quarter of positive earnings [18] - Average revenue per clinical test (AUP) increased by 3% year-over-year, with a sequential increase of $15 [19][20] Business Line Data and Key Metrics Changes - Clinical business revenue growth was 15% excluding the Pathline acquisition, driven by effective execution of the commercial strategy [11] - NGS revenue grew by 24% year-over-year, accounting for 33% of total clinical revenue year-to-date [19] - Total test volumes increased by 15% in Q3, with a same-store revenue growth of 15% [18][19] Market Data and Key Metrics Changes - The therapy selection and MRD markets represent over $40 billion of addressable market opportunity, both growing rapidly [10] - MRD cancer surveillance and monitoring is estimated to be a $30 billion addressable market, growing at a 30% CAGR [14] Company Strategy and Development Direction - The company is focused on advancing NGS and MRD long-term growth initiatives, including the launch of the Radar ST MRD assay [6][10] - The acquisition of Pathline enhances the company's presence in the Northeast, allowing for faster turnaround times and a broader test menu [8] - The company aims to consolidate send-out testing to simplify operational workflows and improve patient experience [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about significant opportunities in cancer testing, particularly in community settings where 80% of cancer care is delivered [7] - The company anticipates continued strong clinical performance and growth in NGS and MRD markets [17] - Full-year consolidated revenue guidance is revised to a range of $720 to $726 million, representing growth of 9% to 10% over 2024 [22][23] Other Important Information - The company has received Moldex approval for Radar ST in subsets of head and neck and breast cancer, preparing for a robust launch in Q1 2026 [13] - The LIMS project is expected to deliver operational efficiencies starting in 2026 and 2027 [22][44] Q&A Session Summary Question: How comfortable is the company with the guidance and the latest on PanTracer LBx? - Management believes they are in a good position to meet Q4 expectations and confirmed that PanTracer LBx does not require approval to meet guidance [27][32] Question: What is the growth outlook for MRD and its reimbursement? - Management expects MRD to contribute to revenue in 2026, with a slow revenue build anticipated [33][34] Question: Where is the company seeing wins in the NGS business? - Most growth is coming from community oncology practices, with strong performance from the PanTracer family of products [38][41] Question: What are the expected benefits from the LIMS rollout? - The LIMS system will simplify operations, improve turnaround times, and enhance customer experience, with benefits expected to materialize in 2026 and beyond [42][46] Question: How is the company addressing the challenges in the pharma business? - The company is focusing on execution excellence and leveraging new products like Radar ST and PanTracer LBx to regain traction in the pharma segment [54][56]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $188 million, representing a year-over-year growth of 12% and a sequential increase of 4% from Q2 2025 [11][18] - Clinical revenue grew by 18% year-over-year, while non-clinical revenue declined by 27% due to weakness in pharma revenue [18] - Adjusted EBITDA was $12.2 million, marking the ninth consecutive quarter of positive earnings [18] - Average revenue per clinical test (AUP) increased by 3% year-over-year and 4% sequentially from Q2 [19] Business Line Data and Key Metrics Changes - Clinical business revenue growth was driven by a 15% increase in test volumes and a 4% increase in AUP, excluding the Pathline acquisition [11][19] - NGS revenue grew by 24% year-over-year, accounting for 33% of total clinical revenue year-to-date [19] - Non-clinical revenue accounted for less than 9% of total revenue in Q3, consistent with expectations [12] Market Data and Key Metrics Changes - The therapy selection and MRD markets represent over $40 billion of addressable market opportunity, with MRD cancer surveillance and monitoring growing at a 30% CAGR [10][14] - The company estimates that MRD market penetration is less than 10%, indicating significant growth potential [14] Company Strategy and Development Direction - The company is focused on advancing NGS and MRD long-term growth initiatives, including the launch of the Radar ST MRD assay [5][13] - The acquisition of Pathline enhances the company's presence in the Northeast, allowing for faster turnaround times and a broader test menu [7][8] - The company aims to consolidate send-out testing to simplify operational workflows and improve patient experience [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the significant opportunities in cancer testing, particularly in community settings where 80% of cancer care is delivered [6] - The company is committed to innovation and operational excellence, which are expected to drive sustainable and profitable growth [23] - Full-year consolidated revenue guidance is revised to a range of $720 to $726 million, representing growth of 9% to 10% over 2024 [21][22] Other Important Information - The company has received Moldex approval for Radar ST in subsets of head and neck and breast cancer, with a robust launch planned for Q1 2026 [13] - Cash flow from operations was positive at $9 million, with total cash at $164 million, enabling continued investment in business growth [20] Q&A Session Summary Question: How comfortable is the company with the guidance and the latest on PanTracer LBx? - Management believes they are in a good position to meet Q4 expectations and confirmed that approval for liquid biopsy is not needed to meet guidance [25][26] Question: What are the growth drivers expected for 2026? - Growth drivers for 2026 are expected to be similar to 2025, with strong clinical performance and ongoing NGS growth [30] Question: Where is the company seeing the most wins on the customer side for NGS? - Most growth is coming from community oncology practices, with strong performance from the PanTracer family of products [38][39] Question: What is driving the acceleration in the base clinical business? - Effective execution of the Protect, Expand, Acquire strategy, new product introductions, and salesforce expansion are key drivers [66][68] Question: How is the Radar ST MRD assay being received following the favorable summary judgment? - There is increasing positive sentiment in the community oncology setting regarding the ability to re-enter the market with Radar ST [81] Question: What is the company's strategy for the LIMS rollout? - The LIMS consolidation is expected to deliver efficiencies and cost benefits, with early benefits anticipated in 2026 [44][47]

Core Insights - Telo Genomics' abstract on its telomere-based Minimal Residual Disease (MRD) technology has been accepted for presentation at the 2025 American Society of Hematology (ASH) Annual Meeting, indicating the commercial potential of its innovation in the precision oncology market [2][5]. Company Overview - Telo Genomics is a leader in developing diagnostic and prognostic tests for human diseases through a proprietary multi-factor analysis of telomeres [2][10]. - The company utilizes a non-invasive liquid biopsy approach for MRD assessment, which is expected to provide actionable information on cancer relapse risk [3][10]. MRD Technology - The MRD clinical methodology combines MRD assessment with risk profiling of individual cancer cells using the TeloView® platform [3]. - MRD testing is gaining traction as a valuable tool in oncology, with the global MRD testing market projected to reach USD 4.1 billion by 2032 [7]. Market Context - The acceptance of Telo's abstract at ASH 2025 is seen as a significant recognition of its technology and progress towards clinical adoption, reinforcing its position in a multi-billion-dollar diagnostics market [5]. - The total addressable market for multiple myeloma assays is over 750,000 tests per year in the US, highlighting the demand for effective MRD testing solutions [9]. Multiple Myeloma Insights - Multiple myeloma is the second most common blood cancer, with 35,000 new cases annually in the US and approximately 180,000 patients undergoing treatment at any given time [9]. - The introduction of next-generation therapies has improved the median survival rate to over 5 years, but the disease remains incurable, emphasizing the need for effective monitoring and treatment strategies [9].

Core Insights - Quest Diagnostics (DGX) has partnered with Haystack Oncology and Rutgers Cancer Institute to evaluate the Haystack MRD test for optimizing postoperative therapy in stage II/III non-small cell lung cancer (NSCLC) patients [1][3][9] Company Developments - Haystack MRD is a lab-developed test (LDT) validated in a CLIA-certified laboratory and is commercially available through Quest Diagnostics [2][9] - The MRD-PORT Trial (NCT06979661) is a prospective phase II study assessing the use of Haystack MRD to guide postoperative radiation and systemic therapies based on residual tumor DNA presence [3][4] - In addition to the lung cancer study, a previous collaboration in 2023 focused on using Haystack MRD for early-stage triple-negative breast cancer treatment [3] Industry Prospects - The global minimal residual disease (MRD) market was valued at $2.50 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 10.1% through 2030, driven by rising cancer incidence, technological advancements, and integration with personalized medicine [6] - The FDA granted Breakthrough Device Designation to Haystack MRD for identifying MRD-positive patients with stage II colorectal cancer, indicating its potential in guiding adjuvant therapy [5] Other Developments in the Industry - Quest Diagnostics has introduced an advanced pharmacogenomic (PGx) laboratory test service to help providers understand patients' genetic responses to drug therapies, aiming to prevent therapeutic failures and adverse drug interactions [7] - Competitors like QIAGEN and Exact Sciences are also advancing in the molecular diagnostics space, with QIAGEN achieving CE-IVDR certification for its testing systems and Exact Sciences launching a multi-cancer early detection blood test [8][11]

Core Viewpoint - Haystack Oncology, a subsidiary of Quest Diagnostics, has initiated a research collaboration with Rutgers Cancer Institute to evaluate the Haystack MRD test for optimizing postoperative therapy in patients with stage II/III non-small cell lung cancer (NSCLC) [1][2]. Group 1: Research Collaboration and Study Details - The collaboration aims to assess the use of the Haystack MRD test, a highly sensitive circulating tumor DNA (ctDNA) test, to guide postoperative therapy decisions [1]. - The MRD-PORT Trial (NCT06979661) is a prospective phase II study that will determine if the presence of residual tumor DNA after surgery can inform the use of radiation and systemic therapies [1][2]. - Patients testing positive for ctDNA post-surgery will be considered for adjuvant radiation and systemic therapies based on tumor biology and clinical context [2]. Group 2: Importance of ctDNA Testing - ctDNA MRD tests are increasingly recognized for their potential to identify residual or recurring cancer in patients with solid tumors [3]. - A study published in NEJM in April 2025 indicated that ctDNA testing using Haystack MRD identified clinical complete response at a median of 1.4 months, significantly faster than imaging tests which took over 6 months [3]. - A survey revealed that 96% of oncologists believe MRD testing can detect cancer recurrence earlier than current methods [3]. Group 3: Context of Lung Cancer - Lung cancer remains the leading cause of cancer-related deaths in the U.S., with high recurrence rates in stage II and III NSCLC patients [4]. - Studies indicate that patients who test positive for ctDNA after surgery experience significantly worse progression-free survival and overall survival compared to those who test negative [4]. Group 4: Company Background - Haystack Oncology has over 20 years of collaboration in advancing liquid biopsy technologies and developed the Haystack MRD test, which detects ultralow levels of ctDNA [5][6]. - The test is available for commercial use as a lab-developed test (LDT) by Quest Diagnostics and is also utilized in clinical trials as an investigational device [6].