Accessibility StatementSkip Navigation IRVING, Texas, Nov. 17, 2025 /PRNewswire/ -- Caris Life Sciences®Â (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced that the company will attend the following investor conferences: Contact [email protected] to schedule meetings. About Caris Life SciencesCaris Life Sciences® (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer that is acti ...

Financial Data and Key Metrics Changes - Total revenues increased 113% year-over-year to $216.8 million, marking a record-breaking quarter for the company [7][22] - Gross margins improved significantly to 68%, up from 43.7% in the same quarter last year [9][26] - Positive adjusted EBITDA of $51.2 million and net income of $24.3 million were reported, along with positive free cash flow of $55.3 million [10][29] - Cash on hand grew to nearly $760 million, an increase of 4.7% sequentially [10] Business Line Data and Key Metrics Changes - Elective profiling services revenues increased to $207.6 million, representing over 121% year-over-year growth [7][22] - Pharma R&D services revenues increased to $9.2 million, an increase of 18.3% year-over-year [7][22] - Clinical case volumes were slightly less than 51,000 individual profiles, reflecting an 18.2% year-over-year growth [8][11] - Average Selling Price (ASP) increased to $4,089 per profile, representing an 87% year-over-year growth [8][9] Market Data and Key Metrics Changes - The company has reached approximately 6,000 oncologists across the country, with 40% of blood cases also having a tissue case performed, up from the mid-30% range [12][70] - The penetration rate for comprehensive genomic profiling remains relatively low at about 30%, indicating significant growth opportunities [11] Company Strategy and Development Direction - The company aims to incorporate whole genome sequencing into its early detection tests, moving towards personalized disease prevention [5][6] - The focus remains on expanding the technology platform and developing new products, particularly in multi-cancer early detection [10][30] - The company is strategically assessing opportunities for expansion within marketing and sales, as well as external opportunities [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of precision medicine and the potential for significant advancements in early detection and MRD solutions [20][21] - The company anticipates continued improvement in commercial reimbursement and expects to see a positive trend in collections from commercial payers [23][24] - Management is optimistic about achieving a full-year gross margin of 62% for 2025, up from 43.4% in 2024 [28] Other Important Information - The company has generated a cumulative total of over 1,150 peer-reviewed publications through its Precision Oncology Alliance [14] - The Achieve program remains a cornerstone of the early detection platform, with strong representation across normal and pre-malignant populations [20] Q&A Session Summary Question: What is the implied Q4 revenue and underlying gross margins excluding true-ups? - The implied Q4 revenue is expected to be in the $200 million-$210 million range, with underlying gross margins around 61% excluding true-ups [33] Question: Is the colorectal MRD data sufficient for submission to CMS? - The data is sufficient for submission, but the company is cautious about the response from CMS and has additional data ready [34][35] Question: What is the pricing strategy for early detection tests? - The company plans to adopt a premium pricing strategy for its early detection tests, reflecting the unique capabilities of its technology [81] Question: How does the company view the growth of blood-based therapy selection volumes? - The company has seen an acceleration in blood-based therapy selection volumes, with expectations for continued growth as more physicians become comfortable with the offerings [70] Question: What are the expectations for pharma R&D services in Q4? - The company expects pharma R&D services to contribute $20 million-$30 million in Q4, driven by ongoing contracts and partnerships [72][74]

Financial Performance - For the three months ended September 30, 2025, total revenue was $216.8 million, compared to $101.6 million for the same period in 2024, representing a year-over-year increase of 113%[213] - The company achieved net income of $24.3 million for the three months ended September 30, 2025, compared to a net loss of $(67.7) million in 2024[213] - For the nine months ended September 30, 2025, total revenue was $519.1 million, up from $282.3 million in 2024, marking an increase of 84%[213] - Adjusted EBITDA of $51.2 million for the three months ended September 30, 2025, compared to $(45.6) million in 2024[213] - Net income for the nine months ended September 30, 2025, was a loss of $150.0 million, an improvement from a loss of $244.9 million in the same period in 2024[284] Clinical Cases and Services - The number of clinical cases for the three months ended September 30, 2025, was 50,763, up from 42,956 in 2024, indicating a growth of 18%[215] - The number of clinical cases associated with MI Profile and Caris Assure increased from 38,409 and 4,547 cases, respectively, for the three months ended September 30, 2024, to 43,226 and 7,537 cases, respectively, for the same period in 2025, a total increase of 7,807 cases, or 18.2%[241] - The number of clinical cases associated with MI Profile increased from 107,930 to 126,160, representing a total increase of 27,797 cases or 23.4% year-over-year[261] Revenue Sources - Revenue from pharma research and development services grew by 18% year-over-year for the three months ended September 30, 2025, and 25% for the nine months ended September 30, 2025[216] - Revenue from molecular profiling services increased to $207.6 million for the three months ended September 30, 2025, from $93.8 million for the same period in 2024, representing an increase of $113.8 million, or 121.3%[239] - Molecular profiling services revenue increased to $484.6 million for the nine months ended September 30, 2025, up $229.9 million or 90.3% from $254.7 million in 2024[260] Expenses - Selling and marketing expenses were $41.3 million for the three months ended September 30, 2025, an increase of $4.5 million, or 12.3%, compared to $36.8 million for the same period in 2024[251] - General and administrative expenses increased to $52.0 million for the three months ended September 30, 2025, from $40.9 million for the same period in 2024, an increase of $11.1 million, or 27.2%[252] - Research and development expenses were $21.6 million for the three months ended September 30, 2025, compared to $27.6 million for the same period in 2024, a decrease of $6.0 million, or 21.7%[236] - Total costs and operating expenses for the three months ended September 30, 2025, were $184.2 million, compared to $162.5 million for the same period in 2024, an increase of $21.7 million, or 13.3%[236] Cash and Financing - Cash, cash equivalents, restricted cash, and marketable securities totaled $759.3 million as of September 30, 2025[213] - The company completed its IPO on June 20, 2025, raising net proceeds of $459.5 million from the sale of 23,529,412 shares at $21.00 per share[213] - Free cash flow for the nine months ended September 30, 2025, was $27.2 million, compared to a negative free cash flow of $212.4 million in the same period in 2024[285] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $661.6 million, mainly from proceeds of $528.5 million from the IPO[293] Debt and Interest - The 2023 Term Loan Agreement has an outstanding principal amount of $400.0 million, with a fixed interest rate of 10.8% as of September 30, 2025[298] - Interest income for the three months ended September 30, 2025, was $7.4 million, compared to $1.7 million for the same period in 2024, an increase of $5.6 million, or 320.5%[238] - Interest expense for the nine months ended September 30, 2025, was $45.5 million, an increase of $8.7 million or 23.8% compared to $36.8 million in 2024[277] Accounting and Revenue Recognition - The company recognized revenue in accordance with ASC Topic 606, indicating adherence to established accounting standards[306] - The company recognizes revenue from molecular profiling services upon delivery of results to physicians, identifying each sale as a single performance obligation[308] - The company recognizes pharma research and development services revenue over the period in which services are provided, using either output or input methods for revenue recognition[311] Market and Risk Factors - The company is subject to market risk from interest rate changes, but due to the short-term maturities of its investments, a 100 basis point change would not materially affect the fair market value of cash and investments[317] - The company has not engaged in foreign currency hedging transactions and does not currently face significant foreign currency risk, although this may change with international expansion[319]

Financial Performance - Total revenue increased to $216.8 million, a 113% year-over-year increase[10] - Molecular Profiling Services revenue increased to $207.6 million, a 121% year-over-year increase[10] - Pharma R&D Services revenue increased to $9.2 million, an 18% year-over-year increase[10] - Clinical ASP improved by 87%, from $2,184 to $4,089[13] - Achieved Positive Adjusted EBITDA of $51.2 million and GAAP Net Income of $24.3 million[13] - Achieved Positive Free Cash Flow of $55.3 million[13] - Q3 2025 gross margin was 68%, a ~2,432 bps improvement[13] Clinical Volume and Data - Clinical volume grew by 18%, completing 50,763 clinical cases[13] - The dataset surpassed 959,000+ genomic profiles and 660,000+ matched profiles including over 577,000 WES and 628,000 WTS[13] Guidance - Updated CY 2025 total revenue guidance to $720 - $730 million, representing 75-77% year-over-year growth[50] - Updated CY 2025 clinical therapy selection volume growth to 21-22% year-over-year[50] Partnership - 97 POA sites with now over 1,150 publications[13]

Financial Performance - Total revenue for Q3 2025 was $216.8 million, an increase of 113.4% compared to $101.6 million in Q3 2024[8] - Revenue from molecular profiling services reached $207.6 million, reflecting a growth of 121.3% year-over-year[9] - Net income for Q3 2025 was $24.3 million, compared to a net loss of $(67.7) million in Q3 2024, marking a 135.9% improvement[12] - Adjusted EBITDA for the quarter was $51.2 million, a significant increase of 212.2% from a loss of $(45.6) million in the previous year[13] - The company raised its full-year 2025 revenue guidance to a range of $720 million to $730 million, indicating a year-over-year growth of 75% to 77%[14] - Total revenue for the three months ended September 30, 2025, was $216,833,000, a 113% increase from $101,620,000 in the same period of 2024[28] - Molecular profiling services revenue reached $207,587,000, up from $93,803,000, representing a 121% year-over-year growth[28] - Net income for the three months ended September 30, 2025, was $24,325,000, compared to a net loss of $67,729,000 in the same period of 2024[28] Operational Metrics - Total clinical case volume increased by 18.2%, totaling 50,763 cases in Q3 2025 compared to 42,956 cases in Q3 2024[5] - The average selling price (ASP) for total clinical services rose by 87.2% to $4,089 in Q3 2025, up from $2,184 in Q3 2024[7] - The company completed over 959,000 total profiles, including more than 577,000 Whole Exome and 628,000 Whole Transcriptome profiles by September 30, 2025[6] Cash Flow and Liquidity - Positive net cash flow from operating activities was $62.4 million, a 189.9% improvement from $(69.4) million in the prior year[13] - Cash, cash equivalents, and restricted cash increased to $754,739,000 as of September 30, 2025, from $65,442,000 at the end of 2024[30] - Net cash provided by operating activities for the nine months ended September 30, 2025, was $38,375, compared to a net cash used of $206,278 in the same period of 2024[33] - Free cash flow for the nine months ended September 30, 2025, was $27,205, an improvement from a negative free cash flow of $212,432 in the same period of 2024[36] - The company raised $528,459 from its initial public offering, contributing to a net cash provided by financing activities of $661,590 for the nine months ended September 30, 2025[33] Balance Sheet - Total assets as of September 30, 2025, amounted to $984,571,000, significantly higher than $343,734,000 as of December 31, 2024[30] - Current assets increased to $854,245,000 as of September 30, 2025, compared to $215,729,000 at the end of 2024[30] - Total liabilities decreased to $506,207,000 as of September 30, 2025, down from $620,921,000 as of December 31, 2024[30] - Total shareholders' equity improved to $478,364,000 as of September 30, 2025, from a deficit of $2,498,838,000 at the end of 2024[31] - The company’s accumulated deficit as of September 30, 2025, was $2,630,693,000, compared to $2,472,300,000 at the end of 2024[31] Other Financial Metrics - The company reported a basic net income per share of $0.09 for the three months ended September 30, 2025, compared to a loss of $2.59 per share in the same period of 2024[28] - Net loss for the nine months ended September 30, 2025, was $150,045, a decrease from a loss of $244,943 in the same period of 2024, representing a 38.6% improvement[33] - Adjusted EBITDA for the nine months ended September 30, 2025, was $31,665, compared to a loss of $166,564 in the same period of 2024, indicating a significant turnaround[35] - Changes in fair value of financial instruments resulted in a gain of $52,285 for the nine months ended September 30, 2025, compared to a loss of $6,067 in the same period of 2024[35] - The company reported a net cash used in investing activities of $11,170 for the nine months ended September 30, 2025, compared to a net cash provided of $55,222 in the same period of 2024[33] - The company experienced a significant increase in accounts receivable, which rose to $61,232 for the nine months ended September 30, 2025, compared to a decrease of $15,009 in the same period of 2024[33] - Stock-based compensation expense for the nine months ended September 30, 2025, was $56,639, significantly higher than $13,666 in the same period of 2024[33]

Core Insights - Caris Life Sciences has identified TET2 clonal hematopoiesis (CH) as a promising biomarker for improved response to immune checkpoint inhibitor (ICI) therapy in patients with solid tumors [1][3] - The study, led by Dr. Padmanee Sharma, utilized TET2-mutant laboratory models to explore how these mutations influence immune dynamics within the tumor microenvironment [2] - The research analyzed outcomes from nearly 36,000 non-small cell lung cancer (NSCLC) patients and over 25,000 colorectal cancer (CRC) patients, providing substantial evidence supporting TET2-CH as a potential biomarker for enhanced ICI response [3] Company Overview - Caris Life Sciences is a leading AI TechBio company focused on precision medicine, developing innovative solutions to transform healthcare through comprehensive molecular profiling and advanced AI applications [6] - The company has created a large-scale, multimodal clinico-genomic database to analyze the molecular complexity of diseases, enhancing early detection, diagnosis, monitoring, therapy selection, and drug development [6][7] - Caris operates internationally with offices in multiple locations, including the U.S., Japan, and Switzerland, and aims to realize the potential of precision medicine to improve human health [7]

Core Insights - Caris Life Sciences will report its third quarter 2025 financial results on November 5, 2025, and will host a conference call at 3:30 p.m. CT [1] - The company is recognized as a leading, patient-centric, next-generation AI TechBio firm and a pioneer in precision medicine [2] Company Overview - Caris Life Sciences specializes in developing and commercializing innovative healthcare solutions through comprehensive molecular profiling and advanced AI and machine learning algorithms [2] - The company has established a large-scale, multimodal clinico-genomic database to analyze the molecular complexity of diseases, enhancing precision medicine diagnostic solutions [2] - Founded with the vision to improve the human condition through precision medicine, Caris is headquartered in Irving, Texas, with additional offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan, and Basel, Switzerland [2]

Core Insights - Caris Life Sciences will present six studies at the ESMO Congress 2025, showcasing the impact of multiomics in precision medicine and cancer treatment [1][2][3] Research Highlights - The studies involve collaboration with over 25 leading cancer centers globally, emphasizing Caris' leadership in next-generation sequencing and biomarker discovery [2][7] - Tumor types covered include colorectal, gastric, breast, pancreatic, head & neck, prostate, urothelial, renal, and biliary tract cancers [2] Presentation Formats - The research will be presented in various formats: one oral "Proffered Paper," one mini-oral, and four poster presentations [2] - Key presentations include topics on Mismatch Repair Deficiency and its implications for immune checkpoint blockade [3][4] Company Overview - Caris Life Sciences is a pioneer in precision medicine, utilizing advanced AI and machine learning to enhance molecular profiling and cancer treatment [9][10] - The company aims to improve clinical outcomes through innovative research and collaboration within the Caris Precision Oncology Alliance, which includes 97 cancer centers [7]

Core Insights - Caris Life Sciences, Inc. is recognized for its advancements in precision medicine, utilizing whole exome and transcriptome sequencing alongside AI-driven insights for cancer detection and therapy selection [1] - The company reported significant growth in Q2 2025, with revenues reaching $181.4 million, an 81% increase year-over-year, and molecular profiling revenue rising nearly 86% [2] - Caris Life Sciences achieved profitability on an adjusted EBITDA basis, generating $16.7 million in EBITDA and $5.9 million in free cash flow, indicating strong investor confidence [2] Financial Performance - Q2 2025 revenue was $181.4 million, reflecting an 81% year-over-year growth [2] - Molecular profiling revenue increased by nearly 86% [2] - Gross margins improved to 62.7% from 37.5% a year ago [2] - The company completed over 50,000 clinical therapy selection cases [2] - Generated $16.7 million in adjusted EBITDA and $5.9 million in free cash flow [2] Scientific Advancements - Caris Life Sciences is enhancing its leadership in precision oncology, with recent findings on tumor-infiltrating clonal hematopoiesis (TI-CH) published in the New England Journal of Medicine [3] - The MI Cancer Seek® assay, an FDA-approved AI-enabled liquid biopsy platform, has shown broad clinical utility for early cancer detection and therapy guidance [4] - New data on sequencing strategies in breast cancer subgroups demonstrates the application of AI-driven molecular insights in treatment decisions [5]

Core Insights - The individual has a B.Tech degree in Mechanical Engineering and nearly twenty-five years of experience in the oil and gas sector, primarily in the Middle East [1] - The investment strategy is informed by traits of efficiency, carefulness, and discipline developed through professional experience [1] - There is a sustained interest in U.S. equity markets, focusing on technology, energy, and healthcare sectors [1] - The investment approach has evolved from growth investing to a blend of value and growth, emphasizing the understanding of business economics and competitive advantages [1] - The individual believes in the importance of allowing time and compounding to enhance investment returns, particularly in high-quality businesses [1] - A moderately conservative orientation is adopted, with a focus on minimizing downside risk as retirement approaches [1] - Recent rebalancing towards income-generating assets such as dividend-paying equities and REITs reflects a shift in investment priorities [1] - Investing is viewed as a means to achieve peace of mind, not just high returns [1] - The individual aims to engage with a community of investors interested in the intersection of business fundamentals and intelligent investing [1] - There is a commitment to investing in ecologically sensitive businesses, indicating a focus on sustainable investment practices [1]