Personalis (NasdaqGM:PSNL) Q4 2025 Earnings call February 26, 2026 05:00 PM ET Company ParticipantsAaron Tachibana - CFO and COOCaroline Corner - Investor Relations ContactChris Hall - CEO and PresidentJason Kritzer - Managing Director and Co-Head of Value TeamRich Chen - Chief Medical Officer and EVP of R&DTom Stevens - VPVidyun Bais - VP of Equity ResearchConference Call ParticipantsBill Bonello - Senior Research AnalystSubbu Nambi - Managing Director and Equity Research AnalystThomas Flaten - Senior Rese ...

Personalis (NasdaqGM:PSNL) Q4 2025 Earnings call February 26, 2026 05:00 PM ET Company ParticipantsAaron Tachibana - CFO and COOCaroline Corner - Investor Relations ContactChris Hall - CEO and PresidentJason Kritzer - Managing Director and Co-Head of Value TeamRich Chen - Chief Medical Officer and EVP of R&DTom Stevens - VPVidyun Bais - VP of Equity ResearchConference Call ParticipantsBill Bonello - Senior Research AnalystSubbu Nambi - Managing Director and Equity Research AnalystThomas Flaten - Senior Rese ...

Personalis (NasdaqGM:PSNL) Q4 2025 Earnings call February 26, 2026 05:00 PM ET Speaker6Greetings, welcome to the Personalis fourth quarter 2025 earnings conference. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your ...

Natera (NasdaqGS:NTRA) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Speaker10Welcome to Natera's 2025 fourth quarter financial results conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press Star, followed by One on your touchtone phone. If anyone has difficulty hearing the conference, please press Star zero for operator assistance. As a reminder, this call is being rec ...

Core Viewpoint - Telo Genomics Corp. has initiated a new clinical trial for Minimal Residual Disease (MRD) in multiple myeloma, collaborating with the University of Athens to enhance its MRD validation program and assess the clinical utility of its TeloView®MRD technology [1][2]. Company Overview - Telo Genomics is a biotech company specializing in advanced telomere analytics, focusing on diagnostic and prognostic innovations, particularly in oncology and neurological diseases [8]. - The company aims to provide actionable insights through its proprietary technology, which has been validated in over 160 peer-reviewed publications and 30 clinical studies involving more than 3,000 patients [8]. Clinical Trial Details - The new clinical trial is part of Telo's multi-center MRD validation program, utilizing well-characterized clinical blood samples from the University of Athens, with an average follow-up of approximately three years [2]. - The study will evaluate the prognostic performance of TeloView®MRD in predicting relapse risk compared to Next-Generation Flow (NGF), a widely used MRD assessment method [3]. Technology and Performance - TeloView®MRD is designed to detect disease with high sensitivity, achieving a limit of detection of 1 in 10^7, significantly outperforming NGF, which can reach a sensitivity of 1 in 10^6 [4]. - In addition to MRD enumeration, TeloView®MRD analyzes the 3D genomic architecture of individual MRD cells, potentially offering additional prognostic insights [4]. Market Context - The global MRD testing market is projected to reach USD 4.1 billion by 2032, driven by advancements in drug development and a growing emphasis on personalized healthcare [6]. - Multiple myeloma is a significant health challenge, with 35,000 new cases annually in the US and a total addressable market for MM assays exceeding 750,000 tests per year [7]. Future Developments - Telo Genomics is advancing its prospective MRD trials with Cleveland Clinic and Jewish General Hospital and plans to announce additional retrospective studies in Q1 2026 [5].

Core Insights - Telo Genomics presented its innovative approach to Minimal Residual Disease (MRD) testing for Multiple Myeloma at the 67th American Society of Hematology Annual Meeting, showcasing the potential of its TeloView® 3D telomere profiling platform [1][4] Company Overview - Telo Genomics is a biotech company focused on developing diagnostic and prognostic tests for human diseases through telomere analysis, with applications in oncology and neurological diseases [9] - The company aims to provide actionable insights for medical professionals treating Multiple Myeloma, a challenging blood cancer [9] MRD Testing Insights - The new MRD evaluation method combines the enumeration of individual MM Circulating Tumor Cells (CTCs) from peripheral blood with the TeloView® platform, achieving a detection limit of 1 in 10^7 [2] - TeloView® has identified distinct 3D genome profile clusters that correlate with mutation rates, with larger studies planned to validate these MRD profiles for predicting relapse risks [3] Market Potential - The global MRD testing market is projected to reach USD 4.1 billion by 2032, driven by advancements in drug development and personalized healthcare [6] - The total addressable market for Multiple Myeloma assays is over 750,000 tests per year in the US, highlighting significant demand for MRD testing [8] Clinical Relevance - MRD is defined as the small number of cancer cells remaining post-treatment, providing critical information for clinicians regarding patient remission status [5] - The FDA's acceptance of MRD as a clinical endpoint for accelerated approval of new therapies in Multiple Myeloma indicates a shift towards more rapid drug approvals [5]

Financial Data and Key Metrics Changes - Total company revenue for Q3 2025 was $94 million, representing a 102% increase year over year [14] - Adjusted EBITDA was $28 million compared to a loss of $14.3 million a year ago [14] - Net income for the quarter was $9.5 million [14] - MRD revenue grew 52% year over year to $56.8 million [14] - Total company gross margin, excluding non-cash revenue from Genentech, was 70% [15] - Total operating expenses were $83.7 million, up 6% year over year [15] Business Line Data and Key Metrics Changes - ClonoSEQ clinical revenue grew 83% year over year and 18% quarter over quarter [6] - ClonoSEQ test volume increased 38% year over year to 27,111 tests delivered [14] - MRD Pharma revenue grew 11% year over year, including $6.5 million in milestone revenue [10] - Immune medicine revenue from pharma and academic services was $3.4 million, down from $5.5 million a year ago [15] Market Data and Key Metrics Changes - Blood-based testing now represents 45% of total MRD test volume, achieving the full-year goal ahead of plan [6] - Community-based testing accounted for 31% of total ClonoSEQ volume [7] - The number of ordering healthcare providers grew 38% year over year to over 4,100 [7] Company Strategy and Development Direction - The company is focused on expanding MRD testing integration into patient care and enhancing clinical utility [4] - EMR integration efforts are aimed at increasing test volume and protecting against competition [8] - The company plans to further expand its EMR footprint and expects continued acceleration from integrated accounts [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of the MRD business, highlighting its cash flow positivity and consistent growth [18] - The company is raising its full-year MRD revenue guidance to a range of $202-$207 million, reflecting stronger than expected performance [17] - Management noted that recent guideline updates are expected to enhance clinical uptake and utilization of MRD testing [30] Other Important Information - The NCCN guidelines were updated to incorporate MRD-guided treatment options, enhancing the clinical relevance of ClonoSEQ [5] - The company achieved several policy wins, including coverage from major payers, which is expected to drive future growth [7] Q&A Session Summary Question: Insights on MRD pharma business backlog - Management indicated that the $200 million backlog is expected to be recognized generally over a five to seven-year timeframe, with strong bookings anticipated for 2026 and beyond [20] Question: Expectations for MRD volume growth in 2026 - Management expressed confidence in achieving growth in the range of 30% for MRD volume in 2026, supported by various underlying factors [22] Question: ClonoSEQ ASP projections for next year - Management refrained from providing specific numbers for 2026 but expressed confidence in achieving meaningful growth in ASP, with a long-term target of $1,700-$1,800 per test [23][24] Question: Community penetration and sales force strategy - Management noted that community penetration is currently at 30% and emphasized the potential for growth, with no immediate plans for significant expansion of the sales force [37][39] Question: Drivers of sequencing gross margin improvement - The increase in sequencing gross margin to 66% was primarily driven by the implementation of NovaSeq X, which contributed significantly to the improvement [42] Question: Impact of EMR tools on testing frequency - Management explained that EMR tools allow for serial testing orders, which are expected to increase testing frequency and improve patient care [44][46] Question: Future potential for ClonoSEQ as a primary endpoint - Management indicated that efforts are ongoing to establish ClonoSEQ as an accelerated endpoint for approval in CLL and DLBCL, with expectations for faster progress compared to multiple myeloma [57]

Summary of Adaptive Biotechnologies FY Conference Call Company Overview - **Company**: Adaptive Biotechnologies (NasdaqGS:ADPT) - **Date**: September 10, 2025 - **Key Speakers**: Chad Robins (CEO), Kyle Piskel (CFO) Key Accomplishments and Goals - Achieved EBITDA profitability ahead of schedule, a significant milestone in the industry [2] - Successfully implemented Flatiron EMR integration and transitioned to NovaSeq X from NextSeqs [2] Market Penetration and Testing Insights - Market penetration for various hematologic malignancies: - Multiple Myeloma: 12% - Acute Lymphoblastic Leukemia (ALL): 28% - Mantle Cell Lymphoma (MCL): 7% - Chronic Lymphocytic Leukemia (CLL): 5% - Diffuse Large B-Cell Lymphoma (DLBCL): 3% [3] - Community penetration is growing rapidly, with a 16% quarter-over-quarter growth in community settings [4][5] - Blood-based testing now accounts for 44% of MRD testing volume, up from 40% in Q2 2024 [11] Testing Frequency and Clinical Utility - Average testing frequency: - ALL: 3.5 to 4 tests per patient per year - Multiple Myeloma: 2 to 2.5 tests per patient per year - CLL: 1 test per patient per year [8] - 80% of community oncologists are utilizing the new serial testing option integrated into EMR systems [10][26] - Clinical utility trials (MASTER and MIDUS) are enhancing market penetration and increasing test frequency [30][32] Reimbursement and Regulatory Updates - Recent CMS reimbursement for surveillance in MCL opens opportunities for other hematologic malignancies [20] - NCCN guideline updates strengthen recommendations for clonoSEQ testing in multiple myeloma [17] EMR Integration and Sales Strategy - 40 Epic integrations and 113 community accounts via oncoEMR, with a focus on quality over quantity [22] - Post-integration, accounts have seen a 25% growth in volume [23] - EMR integration is expected to drive consistent ordering patterns [26] Financial Performance and Projections - Targeting an ASP of $1,300 for clonoSEQ in 2025, with current performance exceeding $1,290 [45] - NovaSeq X rollout expected to improve gross margins by 5% to 8% [47] - Cash burn guidance has been reduced while maintaining over 25% top-line growth [48] Future Outlook - Excitement around the NeoGenomics partnership and its potential impact on community presence [27] - Continued focus on leveraging clinical utility data to drive growth in the community setting [50] - Long-term goal to establish a pan-disease recurrence monitoring paradigm [21] Additional Insights - The company is exploring monetization opportunities for returned assets from Genentech, including a digital TCR antigen map [39][40] - The integration of MRD as a primary endpoint in multiple myeloma trials is expected to enhance the company's pharma business [34][35] This summary encapsulates the key points discussed during the conference call, highlighting the company's achievements, market strategies, and future growth prospects.

Summary of Natera Conference Call Company Overview - **Company**: Natera (NasdaqGS:NTRA) - **Industry**: Life Sciences and Diagnostics Key Points Signatera Performance - Natera reported record sequential volume growth for Signatera, with an upgraded volume growth outlook [3][4] - There is a significant increase in interest in minimal residual disease (MRD) testing, with Natera being the market leader [4][5] - The company noted strong data from the ASCO GI conference, particularly regarding colorectal cancer, which has driven growth [5][6] - New patient starts for Signatera doubled the previous record and tripled the normal figures, indicating robust demand despite competition [7][8] Market Penetration and Growth Potential - Current penetration in the MRD setting is described as low single digits, suggesting substantial growth potential [8][9] - Colorectal cancer is highlighted as a key area for growth due to its clinical utility in decision-making for adjuvant settings and recurrence monitoring [9][10] - Natera is capturing new patients from both newly diagnosed and prevalent populations, indicating a broad market opportunity [10][11] Physician Engagement and Education - Approximately 40% to 50% of oncologists in the U.S. are ordering Signatera, with ongoing efforts to educate more physicians about its benefits [18][19] - The company is expanding its commercial team to enhance physician engagement and increase adoption rates [18][19] Medicare Coverage and Revenue Potential - Natera has seven Medicare coverages and anticipates submitting for an additional ten indications over the next couple of years, potentially generating $250 million to $300 million in incremental revenue [21][24] - The company has a strong track record of quality studies, which is crucial for obtaining Medicare coverage [22][23] International Expansion - Natera is preparing for a commercial launch in Japan, expected in 2027, following FDA approval and pricing discussions with the national health system [28][31] - The colorectal cancer opportunity in Japan is comparable to that in the U.S., with significant unmet needs in the market [30][31] Women's Health and NIPT Market - Natera holds over 50% market share in the NIPT space, with a penetration rate of approximately 65% [32][33] - The company is launching new tests, including a fetal focus test that allows for direct detection of disorders in the fetus without needing the father's sample [36][37] Early Detection Initiatives - The PRESEDE CRC trial is set to provide data on early detection of colorectal cancer, with results expected soon [43][44] - Natera aims to be a major player in early cancer detection, with plans to launch its FIND study by 2027 [45] Financial Outlook - Natera reported a strong second quarter, raising revenue outlook while maintaining operational expense guidance [46][47] - The company is investing in product launches and clinical trials, anticipating significant growth in 2026 as the commercial team matures [48][50] Future Opportunities - The primary opportunities identified include continued growth of Signatera and advancements in AI and data initiatives, which have garnered interest from pharmaceutical partners [51][52] Additional Insights - Natera's focus on high-quality clinical trials and innovative technologies positions it well for future growth in both existing and new markets [40][41]

Financial Data and Key Metrics Changes - Total revenue for the second quarter was $58.9 million, representing a 36% growth year over year, with 85% from the MRD business and 15% from immune medicine [20][21] - MRD revenue grew 42% year over year to $49.9 million, with clinical and pharma contributions of 65% and 35% respectively [20][21] - Sequencing gross margin improved by 14 percentage points year over year to 64%, driven by lower labor and overhead costs alongside increasing volumes and higher pricing [22][23] - Cash burn for the quarter was approximately $11 million, a 36% improvement over the same period last year, ending with a solid cash position of $222 million [7][20] Business Line Data and Key Metrics Changes - ClonoSEQ revenue grew 57% year over year, with over 25,300 tests delivered, up 37% versus the prior year and up 10% sequentially [7][20] - The MRD business achieved positive adjusted EBITDA of $1.9 million, a significant improvement from a deficit of $11.3 million a year ago [23] - Immune medicine revenue was $8.9 million, up 13% from a year ago, with adjusted EBITDA loss improving by 14% year over year [23] Market Data and Key Metrics Changes - Blood-based testing represented 44% of MRD tests, up 40% from a year ago, with multiple myeloma accounting for 41% of U.S. ClonoSEQ volume [8][9] - The average selling price (ASP) for ClonoSEQ tests in the U.S. reached $12.90, a 17% increase year over year [10][21] - The backlog for MRD Pharma business grew to $218 million, up 21% from the prior year, with 175 active global clinical trials [12][13] Company Strategy and Development Direction - The company is focused on expanding EMR integrations to drive volume growth, with significant progress in integrating ClonoSEQ into Flatiron's Onco EMR [11][12] - The MRD Pharma business is expected to continue growing, with a strong pipeline and increasing global support for MRD testing as a key endpoint in clinical trials [13][106] - The company aims to achieve a cash burn target of $25 million to $30 million by scaling revenue generation from pharma partnerships while managing R&D investments [19][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving raised full-year guidance, driven by stronger-than-expected clinical volume performance and higher MRD milestone revenue anticipated for the year [20][26] - The company remains optimistic about the growing global support for MRD testing to accelerate new treatments across various malignancies [13][106] - Management highlighted the importance of the recent NCCN guidelines update for multiple myeloma, which is expected to support increased adoption of ID testing [96] Other Important Information - The company has begun processing ClonoSEQ tests on the NovaSeq X, which is expected to scale operations and improve margins [6] - The integration of ClonoSEQ into EMR systems is seen as a key driver of volume growth, with positive feedback from healthcare providers [11][34] Q&A Session Summary Question: Can you provide insights on the Flatiron integration and its impact on volume growth? - Management noted that the integration with Flatiron is in early stages, but initial results are promising, with expectations for consistent ordering at clinically appropriate time points [34][35] Question: What are the expectations for ClonoSEQ pricing and payer traction? - The company is seeing improvements in pricing due to contracting efforts, particularly with larger national payers, and anticipates continued pricing momentum in the second half of the year [37][38] Question: How does the company plan to balance investments in the business with EBITDA margin potential? - Management indicated that the business is set up to continuously produce positive adjusted EBITDA, with ongoing investments in MRD and international markets to support growth [42][44] Question: What are the implications of the NCCN guidelines update for multiple myeloma? - The update is viewed as a tailwind for the company, reinforcing the importance of ID testing at diagnosis, which is expected to contribute to ongoing volume growth [96][97] Question: Can you elaborate on the NEO collaboration and its expected impact? - The NEO collaboration is in its pilot phase, with expectations for material impact on volumes in 2026 and 2027, while the current focus is on operational processes [86][88]