Investor Presentation NASDAQ:IMDX March 2026 iMDxinc.com Forward-Looking Statements This presentation contains certain "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "target," "believe," "expect," "will," "may," "anticipate," "estimate," "would," "positioned," "future," and other similar expressions that predict or indicate future events or trends or t ...

Core Insights - CoSara, a joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited, is expanding its market presence in South Asia, unlocking a significant market opportunity estimated at $13 billion [2]. Group 1: Market Opportunity - The expansion increases CoSara's addressable market across South Asia, supporting the commercialization of the CoSara PCR Pro point-of-care instrument and tests, as well as the SARAGENE product line [2]. - The total regional opportunity is based on internal analyses and third-party market data, indicating a robust demand for molecular diagnostics in the area [2]. Group 2: Strategic Initiatives - CoSara is establishing distribution channels in newly added markets, which includes evaluating regulatory pathways and identifying priority customer segments [3]. - The company plans to build local manufacturing and distribution capabilities in key regions, including the United States, South Asia, and the Middle East and North Africa, to support scalable global deployment of its PCR point-of-care platform [5]. Group 3: Leadership Insights - The CEO of CoSara highlighted the growing demand for accessible, non-invasive, and reliable testing solutions in South Asia, emphasizing the importance of expanding territory to build relationships with regional partners [4]. - Co-Diagnostics CEO noted that this expansion aligns with their broader strategy of establishing regional infrastructure ahead of product commercialization [5]. Group 4: Future Plans - CoSara plans to host a virtual distributor information session in the second quarter of 2026, followed by an in-person distributor meeting and training event later in the summer [6].

Financial Data and Key Metrics Changes - For the full year 2025, the company achieved 100% year-over-year growth with an adjusted EBITDA margin of 13%, a positive GAAP operating margin, and positive cash flow [6][26] - Total revenue in Q4 2025 was $96.1 million, representing a 113% year-over-year increase, with prenatal revenue at $86.9 million (up 98%) and oncology revenue at $9.1 million (up 736%) [29][21] - Gross margins improved to 71.4% in Q4 2025, a 14.3 percentage point increase year-over-year [25][31] Business Line Data and Key Metrics Changes - Test volumes grew by 51% year-over-year, reaching approximately 170,000 tests in Q4 2025 [20][33] - The average selling price (ASP) increased by 35% year-over-year to $495 for the full year 2025, with a significant sequential increase of $60 per test in Q4 [23][34] - Oncology revenue growth was driven by the adoption of Northstar Select and Response, with a quarter-over-quarter growth of 29% excluding true-up revenue [22][30] Market Data and Key Metrics Changes - The company reached an annualized revenue run rate of $384 million in Q4 2025, indicating strong market demand and growth potential [10][21] - The company has secured Medicare coverage for Northstar Select and signed contracts covering over 250 million lives in the U.S. [8][10] Company Strategy and Development Direction - The company aims to build a category-defining business and enter the S&P 500, focusing on innovation in prenatal and oncology diagnostics [11][46] - The launch of new products, including expanded fetal antigen NIPT and Northstar Select PGx, is expected to drive future growth [12][40] - The company emphasizes operational efficiency and cost reduction, achieving GAAP profitability while maintaining high growth rates [11][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth, citing strong test volume momentum and the impact of new clinical guidelines on market adoption [37][38] - The company anticipates that the recent contract with UnitedHealthcare will enhance ASPs and reduce friction in patient access to tests [42][63] - Management believes that the current guidance for 2026 is conservative, with several growth drivers not fully reflected in the projections [35][79] Other Important Information - The company ended 2025 with approximately $496 million in cash and only $50 million in term debt, positioning it well for future growth [34][35] - The company achieved a significant milestone by going public during a challenging market environment, demonstrating resilience and execution capability [5][6] Q&A Session Summary Question: Awareness of UNITY among providers - Management noted that around 50% of providers are unaware of UNITY, indicating significant growth potential as awareness increases [49][50] Question: Conversations with health systems regarding MFMs - Management highlighted the importance of MFMs in driving test adoption and the ongoing discussions to increase uptake among larger health systems [52][53] Question: New provider metrics for Northstar - Management reported a record increase in active ordering providers in Q4, signaling strong growth potential for Q1 2026 [56][58] Question: Gross margin expectations - Management indicated that gross margins are expected to remain stable in the high 60% to low 70% range, without aggressive expectations for expansion [60] Question: Impact of UnitedHealthcare contract - Management expects higher ASPs from the in-network contract with UnitedHealthcare, which covers both prenatal and oncology products [63][65] Question: Competitive landscape and impact from Natera - Management stated that they have not seen any negative impact from competition, as evidenced by strong test volume growth and increased prenatal revenues [68]

Core Insights - BillionToOne, Inc. reported significant financial growth in Q4 2025 and raised its revenue guidance for 2026, reflecting strong demand for its molecular diagnostics products [1][4]. Financial Highlights - Total revenue for Q4 2025 was $96.1 million, a 113% increase from $45.1 million in Q4 2024 [5][7]. - Prenatal testing revenue reached $86.1 million in Q4 2025, up 99% from $43.2 million in Q4 2024 [5][11]. - Oncology testing revenue surged to $9.1 million in Q4 2025, an increase of 735% from $1.1 million in Q4 2024 [5][11]. - Gross profit margin improved to 71% in Q4 2025, compared to 57% in Q4 2024, driven by higher average selling prices (ASP) and reduced costs [8][12]. - Operating income was $10.3 million in Q4 2025, reversing an operating loss of $11.7 million in Q4 2024 [9][10]. Recent Operating Highlights - The company delivered 170,000 tests in Q4 2025, a 47% increase from 116,000 tests in Q4 2024 [5][6]. - BillionToOne launched new prenatal and oncology products in early 2026, including non-invasive prenatal tests for fetal antigen status and expanded applications for its Northstar platform [5][14]. - The company expects full-year 2026 revenue to be between $430 million and $445 million, representing a growth of 41% to 46% compared to 2025 [14]. Full Year 2025 Financial Results - Total revenue for 2025 was $305.1 million, a 100% increase from $152.6 million in 2024 [11][12]. - Gross profit for 2025 was $208.5 million, with a gross margin of 68%, up from 53% in 2024 [12][13]. - Net income available to common shareholders for 2025 was $2.9 million, or $0.14 per diluted share, compared to a net loss of $41.6 million in 2024 [13]. Cash Position - As of December 31, 2025, BillionToOne held approximately $496.0 million in cash and cash equivalents, indicating a strong liquidity position [13][22].

Core Insights - BillionToOne, Inc. has announced a collaboration with Epic to integrate its prenatal and oncology testing portfolio with Epic's Aura diagnostics suite, enhancing the patient and provider experience [1][2][3] Company Overview - BillionToOne is a next-generation molecular diagnostics company based in Menlo Park, California, focused on creating accessible and accurate tests [5] - The company utilizes a patented Quantitative Counting Templates™ (QCT™) molecular counting platform, which is the only multiplex technology capable of accurately counting DNA molecules at the single-molecule level [5] Integration Details - The integration allows clinicians to order BillionToOne's UNITY Complete® prenatal test and Northstar Select® and Northstar Response® liquid biopsy tests directly within Epic's EHR [2][4] - Test results will flow back into the electronic health record, facilitating clinical decision support and improving the experience for patients and providers across various healthcare settings [2][4] Clinical Impact - UNITY Complete is the first clinically validated non-invasive prenatal test that provides direct fetal risk assessment for multiple conditions from a single maternal blood sample [3] - Northstar Select assists in identifying appropriate therapies for advanced cancer patients, while Northstar Response enables ongoing treatment monitoring [3] User Experience Enhancement - Results will be delivered directly into Epic and accessible through the MyChart patient portal, promoting faster clinical decision-making and a more connected patient experience [4]

Core Viewpoint - BillionToOne, Inc. is set to participate in the 44th Annual J.P. Morgan Healthcare Conference, highlighting its commitment to advancing molecular diagnostics [1] Company Overview - BillionToOne is headquartered in Menlo Park, California, and focuses on creating accessible and accurate molecular diagnostic tests [3] - The company utilizes a patented technology called Quantitative Counting Templates™ (QCT™), which is the only multiplex technology capable of counting DNA molecules at the single-molecule level [3]

Core Insights - QuidelOrtho Corporation is at the forefront of in vitro diagnostics, focusing on innovative solutions that enhance patient care [1][7] - The latest podcast episode discusses transformative diagnostic technologies that are reshaping patient management and outcomes [2][3] Diagnostic Innovations - High-sensitivity troponin testing is enabling faster diagnosis and treatment for cardiac patients, improving care efficiency [5] - Non-invasive assays are being developed to enhance gastrointestinal health, reducing the need for invasive procedures [5] - Rapid combination tests are assisting clinicians in effectively managing respiratory surges, streamlining patient care [5] - Advances in molecular diagnostics, informatics, and artificial intelligence are facilitating more personalized and smarter healthcare solutions [5] Research and Development - QuidelOrtho's R&D strategies are focused on addressing global healthcare challenges through innovative diagnostic solutions [5][7] - Collaboration and cutting-edge research are key drivers behind the diagnostic breakthroughs that empower clinicians worldwide [3]

Core Insights - Becton, Dickinson and Company (BDX) is expanding its respiratory and sexually transmitted infection diagnostics portfolio in Europe following the IVDR certification of two VIASURE assays for the BD MAX System, aimed at enhancing its molecular testing capabilities [1][8] Group 1: Product Expansion - The newly approved tests include a respiratory virus test that can simultaneously identify COVID-19, flu, and RSV using a single nose swab, and an HSV and syphilis test that detects herpes simplex viruses (HSV-1 and HSV-2) and syphilis bacteria from swabs taken from infected areas [2][8] - The expanded range of tests on the BD MAX system reflects the company's commitment to providing clinically useful molecular tests for respiratory infections and STIs, enhancing diagnostic solutions [3][10] Group 2: Market Impact - Following the announcement, BDX shares declined by 0.4%, but over the past six months, the stock has increased by 16.3%, outperforming the industry growth of 13.9% and the S&P 500's rise of 15.5% [4] - The expansion of the testing menu supports BDX's diagnostics growth strategy by increasing the utility and competitiveness of the BD MAX System in European markets, which is expected to deepen customer reliance and support recurring revenues [5][10] Group 3: Industry Prospects - The molecular diagnostics market is projected to be valued at $45.11 billion by 2025, with a CAGR of 3.8% through 2034, driven by factors such as an aging population and rising incidences of various diseases [11]

Core Viewpoint - BillionToOne, Inc. reported strong financial results for Q3 2025, highlighting significant growth in revenue driven by its innovative molecular diagnostics technology, particularly in prenatal and oncology testing [3][5]. Financial Performance - Total revenue for Q3 2025 was $83.5 million, a 117% increase from $38.4 million in Q3 2024 [5][7]. - Prenatal clinical testing revenue reached $74.1 million, up 102% year-over-year, while oncology clinical testing revenue surged to $8.7 million, reflecting a 664% increase [5][7]. - Gross margin improved to 70% in Q3 2025 from 53% in Q3 2024, driven by higher average selling prices (ASP) and reduced costs per test [5][8]. - Operating income was $9.6 million in Q3 2025, compared to an operating loss of $12.6 million in Q3 2024 [9]. Test Volume and ASP - The company accessioned 162,900 tests in Q3 2025, a 51% increase from 107,900 tests in Q3 2024 [4][5]. - The overall ASP increased by 44% to $501 in Q3 2025 compared to $348 in Q3 2024 [6][7]. Cash Flow and IPO - Positive cash flow of $6.2 million was reported in Q3 2025 [5]. - The company raised gross proceeds of $314.0 million from its initial public offering (IPO) [10]. Future Guidance - BillionToOne expects full-year 2025 revenue to be between $293 million and $299 million, indicating growth of 92% to 96% compared to 2024 [11]. - The anticipated revenue for Q4 2025 is projected to be between $84 million and $90 million, representing an 86% to 100% increase year-over-year [11].

Summary of Castle Biosciences FY Conference Call Company Overview - Castle Biosciences is a molecular diagnostics company focused on proprietary algorithm-driven tests aimed at improving patient management and outcomes [2][3] Industry and Market Insights - The company operates primarily in the dermatology and gastroenterology sectors, with tests designed for conditions such as melanoma, atopic dermatitis, and Barrett's esophagus [5][7] - The total addressable market (TAM) for their tests is significant, with estimates of $540 million for melanoma tests, $820 million for high-risk cutaneous squamous cell carcinoma, and $1 billion for Barrett's esophagus [9][10][11] Financial Performance - In Q3 2025, Castle Biosciences reported a revenue growth of 36% year-over-year, matching the volume growth [2] - Adjusted gross margins decreased to 77% from 82% due to the loss of coverage for squamous cell carcinoma tests [3] - The company ended the quarter with cash and cash equivalents of $287 million, indicating a strong balance sheet [3] Product Developments - The company launched a new test called Advance ADTX for guiding systemic therapy selection in patients with moderate to severe atopic dermatitis [4] - The DecisionDx-SCC test demonstrated the ability to predict the likelihood of response to adjuvant radiation therapy in high-risk cutaneous squamous cell carcinoma patients [6] - Ongoing collaboration with SciBase aims to predict flares in atopic dermatitis patients using electrical impedance spectroscopy technology [7] Clinical Study Findings - A large prospective observational study validated a 487 gene expression profile test for atopic dermatitis, identifying two key profiles: TH2 molecular profile and JAK inhibitor responder profile [12][19] - Patients with a JAK inhibitor responder profile had a 45% chance of achieving EASI-90 (90% clearance) when treated with JAK inhibitors, compared to only 8.3% with TH2 biologic therapy [19] Market Research and Adoption - Approximately 78% of clinicians surveyed indicated they would likely use the new atopic dermatitis test after a brief overview [20] - The target population for the atopic dermatitis test is around 13 million patients aged 12 and older in the U.S. [10][22] Conclusion - Castle Biosciences is positioned for growth with a strong product pipeline and significant market opportunities in dermatology and gastroenterology, supported by promising clinical data and positive clinician feedback [23]