2/26/2026

speaker
Dana
Conference Coordinator

Good afternoon, everyone, and welcome to the CARES Life Sciences Q4 2025 Earnings Call. My name is Dana, and I will be your coordinator today. At this time, all participants are on the listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star-1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker, Russ Denton. Please go ahead.

speaker
Russ Denton
Moderator

Thank you. Earlier today, Karis Life Sciences released financial results for the quarter and year ended December 31st, 2025. Joining the call from Karis today are David Dean-Holbert, our founder, chairman, and CEO, David Spetzler, our president, Brian Burley, our vice chairman and EBP, Bobby Hill, our chief commercial officer, and Luke Power, our CFO. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meeting of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. These risks are discussed in our SEC filings, including our quarterly reports on Form 10-Q, and our annual report on Form 10-K to be filed with the SEC. Assessed as required by law, CARES disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise. The information discussed in this conference call is accurate only as of the live broadcast. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. The reconciliation of these non-GAAP financial measures, the most directly comparable GAAP financial measures, are available in the press release CARES issued today. A copy of today's presentation materials, along with an interim readout of our G1 study, can be found on our website. I will now turn the call over to Brian.

speaker
Brian Burley
Vice Chairman and EVP

Thanks, Russ, and thank you all for joining our fourth quarter 2025 earnings call. This is our first year-end call as a public company following our June IPO last year, and we're pleased to report another record-breaking quarter, finishing the year with excellent performance across the company in terms of growth and underlying financial strength. I want to start with what has always mattered most at Keras, our mission. Keras was founded to make precision medicine a reality. We aim to fundamentally change the way disease is characterized and treated. We believe more information is more power, and every patient deserves more power in the battle against disease. That mission is being powered by a molecular platform which benefits from scale and highly differentiated capabilities, as illustrated on slide three. Our platform continues to scale, and in 2025, we completed just under 200,000 individual cases. With this clinical activity, we have recently reached a platform milestone, as our molecular data set now exceeds over 1 million profiled cases and has grown into one of the most important clinical genomic resources in the industry. As the industry evolves, the intersection of molecular science and AI is accelerating technological innovation. Our philosophy is a long-term strategic orientation to develop the best offerings on the market and to pursue this innovation while generating profitable growth and maintaining financial strength. We've had an outstanding fourth quarter with total revenues increasing 125% year-over-year to $293 million. As demonstrated on slide four, this result was driven primarily by strong performance from clinical profiling. Molecular profiling services revenues increased to $282 million in the fourth quarter, representing an increase of 199% year-over-year. Pharma R&D services revenues were $10.8 million in the fourth quarter and were making important progress in CDX, data discovery, including the December announcement of the Genentech discovery deal, as well as a CDX collaboration. In summary, across the board, we had a very productive fourth quarter, illustrated by the quarter highlights on slide five. The strong revenue performance, combined with the operating leverage inherent in our business model, has produced excellent financial results, including the following. Revenue growth of 125%, which was driven by volume growth of 20%, and a 150% increase in clinical ASP. This revenue growth has led to significantly improved gross margins of 75% on a GAAP basis, up from 54% in the fourth quarter of 2024. It also represents a significant sequential increase from the 68% in the third quarter. With this gross margin improvement, this quarter we generated positive GAAP net income of $82 million, and adjusted EBITDA of $106 million, as well as positive free cash flow of $39.7 million. This is our third straight quarter of positive adjusted EBITDA and positive free cash flow. This strong profitability profile is unique in our industry and provides valuable strategic flexibility for ongoing investment in our tech platform for new products, as well as the ability to develop new channels such as MSED. In addition, our balance sheet continues to strengthen with cash on hand growing to slightly above $800 million, an increase of $43 million in the quarter. The CARES data set has continued to grow with our clinical profiling activity and now exceeds 1 million genomic profiles and 740,000 matched profiles. Since every profile has been generated with our WES-WTS technology for many years, our data set now features 627,000 exomes and 678,000 transcriptomes. This gives our dataset tremendous power for internal product development, as well as attractiveness as a research partner for academic medical centers through the POA, as well as for biopharma. As our results demonstrate, our financial performance gives us unique strategic flexibility, and we intend to use that edge in 2026 to make significant investments in both the early detection business and our therapy selection channel. In early detection, we expect to realize the long-standing vision of our CEO, David Hallberg, of launching a revolutionary cancer early detection test. CARIS Detect has the potential to bend the cancer mortality curve and ultimately make cancer a curable disease. We believe that the implications for this test are truly profound, both for CARIS and for our society. In our core therapy selection business, we plan to invest in our commercial channel to broaden our reach and deepen our relationships to accelerate growth. We have a new chief commercial officer, Bobby Hill, who took on this responsibility in the fourth quarter. We're extremely excited about the opportunities we face and the new initiatives that Bobby is driving, ranging from the expansion of the sales force and territories to enhance programming and education. Finally, we will make these investments while maintaining positive adjusted EBITDA and free cash flow. Our strategy is to maintain financial discipline through a strong balance sheet and profitability, and these financial pillars of strength will allow us to realize our mission of making precision medicine a reality to benefit patients and physicians. I will now turn the presentation over to Bobbie Hill to provide an update on our commercial business and related strategic initiatives. Bobbie?

Disclaimer

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