Committed to solid profitable growth Investor Introduction Q3 2025 Presentation Titel Forward looking and intended use statements Crucial to advancing science Improving healthcare for all Safe Harbor Statement: Certain statements in this presentation may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN's products, d ...

Core Insights - Natera has achieved significant growth since its IPO, with stock prices increasing nearly 10 times from $18 to around $170 and revenues expanding from $190 million to $2 billion, reflecting a 44% revenue growth over the last twelve months [3][11]. Company Overview - Natera specializes in molecular diagnostics, particularly in cancer detection and monitoring, positioning itself as a leader in medical intelligence [4]. - The company's flagship product, Signatera, is a personalized tumor-informed test that utilizes a simple blood draw to detect circulating tumor DNA, revolutionizing cancer monitoring [5][6]. Product and Technology - Natera's technology allows for non-invasive liquid biopsies, providing doctors with critical insights into cancer progression and recurrence risk [6]. - In addition to Signatera, Natera offers Altera for genomic profiling and Empower for hereditary cancer screening, creating a comprehensive suite for cancer care [6]. Market Potential - In the latest quarter, Natera processed over 850,000 tests, generating $546.6 million in revenue, with oncology-related tests growing at 50% year-over-year [9]. - The cell-free DNA testing market is projected to nearly double from $11 billion to around $20 billion in five years, indicating substantial growth potential for Natera [12]. Financial Projections - Natera is expected to sustain 25% annual revenue growth over the next few years, potentially increasing revenue from $1.7 billion last year to approximately $7 billion by 2030 [11]. - If Natera achieves $7 billion in revenue while maintaining a price-to-sales multiple of 13x, the stock price could reach about $700, even with potential multiple compressions [13]. Growth Opportunities - Key areas for growth include expanding the oncology market, scaling internationally, entering adjacent markets, and increasing volume and penetration within existing markets [17]. - Broader insurance coverage and clinical evidence supporting test adoption are critical for expanding market size and pricing power [18]. Competitive Landscape - Natera competes with major players like Roche, Danaher, and Abbott, which have significantly higher revenues, indicating that Natera is still in the early stages of its growth story [12]. - The company must navigate challenges such as reimbursement issues, competitive pressure, regulatory hurdles, and the pace of international adoption [18].

Core Insights - QIAGEN N.V. (QGEN) has achieved CE-IVDR certification for its full portfolio of QIAstat-Dx syndromic testing systems, including an expanded Meningitis/Encephalitis (ME) Panel for diagnosing central nervous system (CNS) infections [1][9] - The expanded ME Panel offers coverage for 16 clinically relevant targets, including cytomegalovirus (CMV) and Streptococcus pyogenes, with a launch planned for September 2025 [4][5][9] - QIAGEN's market capitalization stands at $9.82 billion, with an earnings yield of 5%, significantly higher than the industry average of -22.8% [3] Company Developments - Following the certification announcement, QIAGEN's shares increased by 0.1% to $46.06, indicating positive market sentiment [2][9] - The QIAstat-Dx system can deliver results in about an hour, facilitating early and accurate treatment decisions for clinicians [6] - QIAGEN has installed over 4,600 QIAstat-Dx systems globally, highlighting its critical role in disease diagnosis [10] Industry Context - The global central nervous system therapeutics market is projected to reach $254.6 billion by 2030, growing at a CAGR of 7.7% from 2025 to 2030, driven by an aging population and increased awareness of mental health issues [12] - QIAGEN's advancements in molecular diagnostics align with the growing demand for high-quality diagnostic solutions in the healthcare sector [2][9]

Summary of Insight Molecular Diagnostics FY Conference Company Overview - **Company**: Insight Molecular Diagnostics - **Industry**: Healthcare, specifically diagnostics Core Points and Arguments 1. **Market Opportunity in Transplant Diagnostics**: The U.S. transplant monitoring market is valued at approximately $2 billion, identified as underpenetrated and inefficient, presenting a significant opportunity for disruption [3][4] 2. **Focus on Point of Care**: The company aims to bring testing closer to patients, enhancing care and capturing market share by simplifying workflows and enabling transplant centers to retain revenue [2][4] 3. **Regulatory and Reimbursement Strategy**: The company has a well-defined path to regulatory approval, with expectations to submit to the FDA by the end of the year, and has established reimbursement rates, notably $2,753 from Multi-X [5][8] 4. **High-Value Recurring Revenue**: The diagnostics space offers high margins, with tests costing tens of dollars to manufacture but charging hundreds, leading to a projected $1 billion global opportunity in regulated transplant testing [6][7] 5. **Partnerships and Collaborations**: The company has partnered with three of the top 10 transplant centers in the U.S. and has a strategic relationship with Bio-Rad Laboratories, which has made multiple equity investments [7][8] 6. **Clinical Validation and Data**: The company has published extensively in transplant diagnostics and has shown improved positive predictive value from 50% to 80%, enhancing the reliability of their tests [10][9] 7. **Registry for Data Collection**: A registry is being established to gather data on advanced monitoring technologies, which will support the case for improved patient outcomes and assist in payer negotiations [10][25] Additional Important Content 1. **Physician Adoption Challenges**: Physicians are cautious about adopting new technologies, requiring head-to-head comparisons with existing tests to ensure equivalency [23][24] 2. **Payer Dynamics**: While CMS recognizes the technology's utility, private payers are more hesitant, necessitating further data collection to demonstrate improved outcomes [25] 3. **Future Investment Plans**: The company plans to focus on incremental investments in transplant diagnostics before potentially expanding into heart and lung diagnostics as cash flow improves [16][20] This summary encapsulates the key insights from the conference, highlighting the strategic direction, market opportunities, and challenges faced by Insight Molecular Diagnostics in the healthcare diagnostics industry.

Core Insights - Castle Biosciences significantly outperformed Wall Street expectations in Q2 2025, reporting GAAP EPS of $0.15 and non-GAAP revenue of $86.2 million, both exceeding analyst estimates [1][2] - The company raised its full-year 2025 revenue guidance to a range of $310 million to $320 million, reflecting stronger-than-expected adoption of key tests [10] Financial Performance - GAAP revenue for Q2 2025 was $86.2 million, nearly flat compared to $87.0 million in Q2 2024, with a year-over-year change of -0.9% [2] - Non-GAAP EPS was $0.16, down 51.6% from $0.31 in Q2 2024 [2] - Adjusted EBITDA fell to $10.4 million, a decrease of 51.6% compared to $21.5 million in Q2 2024 [2] - Gross margin decreased from 80.7% in Q2 2024 to 77.3% in Q2 2025, reflecting rising expenses and a less favorable sales mix [2][9] Business Overview - Castle Biosciences specializes in molecular diagnostics, focusing on tests that provide actionable information for managing skin, gastrointestinal, and mental health diseases [3] - The company aims to expand its test portfolio through launches and acquisitions while ensuring reimbursement coverage to support test adoption [4] Recent Developments - Total test volumes reached 26,574 in Q2 2025, a 6% increase year-over-year, primarily driven by core offerings like DecisionDx-Melanoma and TissueCypher [5] - DecisionDx-Melanoma received FDA's Breakthrough Device designation in Q2 2025, indicating regulatory recognition for its innovation [5] - TissueCypher test report volume increased by 117% year-over-year in Q1 2025, attributed to expanded sales force coverage and rising clinical demand [6] - The company discontinued the IDgenetix test due to reimbursement challenges, aiming to streamline operations and improve profitability [8] Strategic Focus - Management is refocusing commercial efforts towards melanoma tests following the loss of Medicare coverage for DecisionDx-SCC, which has significantly impacted revenue [7] - The acquisition of Previse aims to broaden the gastrointestinal segment's potential, although it is not expected to contribute meaningfully to 2025 financial results [6]

Core Insights - Hologic's Molecular Diagnostics business experienced a 7.8% growth in Q2 of fiscal 2025, excluding COVID-19-related sales, but faced challenges due to reduced HIV testing sales in Africa from USAID funding cuts [1][8] - The long-term outlook for the Molecular Diagnostics segment remains positive, driven by over 20 assays on the Panther platforms and a focus on increasing test utilization [2] - Innovations such as the BV/CV/TV assay are contributing to growth, addressing significant testing gaps in women's health [3] - Hologic's Molecular Diagnostics is projected to grow at a compound annual growth rate (CAGR) of 7.3% from 2025 to 2027 [4] Company Performance - Hologic's stock has increased by 3.6% in the last 30 days, contrasting with a 0.7% decline in the industry [7] - The company is trading at a forward five-year sales multiple of 3.44X, below the industry average of 4.11X, and currently holds a Value Score of B [9] - Consensus estimates for Hologic's fiscal 2025 and 2026 earnings show a downward trend, with current earnings projections for fiscal 2025 at $4.19 per share [10][11]

Core Insights - ProPhase Labs Inc. has established a Clinical Science Advisory Board to facilitate the clinical adoption and commercialization of its BE-Smart molecular test for esophageal disease, aiming to set a new standard in early detection and management of esophageal cancer risk [1][10] - The BE-Smart test is positioned to capture a target market of approximately $7 - $14 billion, based on the 7 million endoscopies performed annually in the U.S. for patients at risk of esophageal cancer, with a reimbursement goal of $1,000 - $2,000 per test [3] Company Overview - ProPhase Labs Inc. is a next-generation biotech, genomics, and consumer products company focused on innovative healthcare solutions, including Whole Genome Sequencing and diagnostic developments [11] - The company aims to revolutionize healthcare through actionable insights and is committed to executional excellence and smart diversification [11] Advisory Board Composition - The advisory board includes Dr. Joe Abdo, the inventor of the BE-Smart test, and Mr. James McCullough, founder and CEO of Renalytix, both of whom bring extensive experience in molecular oncology and diagnostic technologies [2][9] - Additional experts will be added to the advisory board to support the initial commercial launch of BE-Smart [2] Product Features and Advantages - BE-Smart offers a unique approach by measuring real-time protein activity, which captures dynamic biological signals of disease progression, requiring only a single 10 µm FFPE biopsy section [3][4] - The test integrates into existing endoscopy and pathology workflows, providing results in under 7 days without added complexity for healthcare providers [3] Clinical Utility - BE-Smart can stratify risk for patients with GERD and Barrett's Esophagus, addressing limitations of current diagnostic tools [4] - The test's design is scalable and cost-efficient, making it an attractive option for clinicians and healthcare systems [4] Competitive Landscape - Other technologies like TissueCypher and EsoGuard have established momentum in esophageal diagnostics, paving the way for broader adoption of molecular tools [5] - BE-Smart builds on this progress by offering a next-generation approach that combines real-time biological precision with streamlined clinical integration [5] Intellectual Property - ProPhase Labs has secured exclusive patents covering proprietary methods for detecting and analyzing eight key proteins critical for esophageal adenocarcinoma progression, providing a competitive advantage in the molecular diagnostics market [6] Clinical Validation - The latest clinical validation manuscript for BE-Smart is under review at the Journal of Clinical Gastroenterology and Hepatology, with a preprint expected soon [7][8]

Financial Data and Key Metrics Changes - Total revenue in Q1 was $29,900,000, with core revenue of $29,500,000, reflecting a 2% decrease year over year [26][27] - GAAP gross margin for Q1 was 41.1%, while non-GAAP gross margin was 41.7%, consistent with expectations [28] - Operating cash flow in Q1 was negative $19,700,000, aligning with expectations due to investments in innovation [28] Business Line Data and Key Metrics Changes - Diagnostics revenue grew 8% year over year, generating $17,700,000 in Q1 [26] - Sample Management Solutions (SMS) revenue decreased 16% year over year to $9,100,000, primarily due to disruption at a large customer in the consumer genomics segment [27][9] - Core revenue was flat year over year after adjusting for the exit from the risk assessment testing business [9] Market Data and Key Metrics Changes - International diagnostics business remained steady, with growth driven by initial orders for the WHO PQ listed hepatitis C self-test [10][12] - The US diagnostics market faced increased headwinds due to budget cuts and staffing reductions at public health organizations [14][16] - Overall market trends in SMS were mixed, with growth in clinical genomics and animal health offset by softness in academic and research labs [11] Company Strategy and Development Direction - The company is focused on three pillars of transformation: strengthening the foundation, elevating core growth, and accelerating profitable growth [5] - Integration of Sherlock Biosciences is progressing well, enhancing the product pipeline with molecular diagnostics innovations [7] - The company plans to launch new products in 2025, including microbiome extraction kits and blood proteomics sample stabilization [35] Management's Comments on Operating Environment and Future Outlook - Management noted ongoing uncertainty in funding for public health initiatives but expressed confidence in the company's ability to navigate these challenges [12][14] - The company is exploring alternative funding sources and maintaining strong relationships with existing customers [39][40] - Management remains optimistic about the potential for growth in international markets despite current funding uncertainties [39] Other Important Information - The board authorized a stock repurchase program of up to $40,000,000 over the next two years, funded from cash on hand [8][29] - The company is transitioning to in-house manufacturing, expected to be substantially complete by the end of Q2 [18][19] Q&A Session Summary Question: What is the outlook for international revenue and HIV testing demands given funding uncertainties? - Management indicated that conversations with funding sources are ongoing and that there is a steady but flat trajectory for international revenue [39][40] Question: Did the company see any pull forward in demand ahead of possible tariffs? - Management confirmed there was no pull forward in demand and noted minimal impact from tariffs due to the transition to US manufacturing [42][43] Question: What is the expected impact of the Together, Take Me Home initiative? - Management confirmed a $4,000,000 headwind for fiscal 2025, with $1,500,000 already recognized in Q1 [49][50] Question: What is the status of the SMS genomics customer and future ordering activity? - Management stated there is no visibility for future orders from the disrupted customer but emphasized growth in SMS from other customers [51][54] Question: What is the expected impact of PEPFAR funding disruptions? - Management noted that the PEPFAR impact for Q1 was around $1,000,000, with expectations for similar levels in Q2 [56][57]

Core Insights - QIAGEN N.V. (QGEN) demonstrated strong potential in molecular diagnostics, with a focus on expanding its test menu to meet long-term targets despite facing macroeconomic challenges and competition [1][3]. Financial Performance - QIAGEN's market capitalization stands at $8.48 billion, with earnings surpassing estimates in three of the last four quarters, resulting in an average surprise of 3.57% [2]. - In the fourth quarter of 2024, sales in the Diagnostic Solutions product group increased by 10% year over year at constant exchange rates (CER), excluding NeuMoDx [4]. Product Development and Growth - The QuantiFERON test achieved sales exceeding $100 million, with significant growth opportunities as only 40% of the global latent TB testing market has transitioned to blood-based testing [4]. - QIAstat-Dx experienced a 25% growth at CER in the fourth quarter, driven by strong demand for consumables and instruments [5]. - QIAGEN invested heavily in research and development (R&D), with R&D expenditures accounting for 9.3% of fourth-quarter sales in 2024, supporting the expansion of its test menu [6]. Market Challenges - QIAGEN faces foreign exchange risks, with over 50% of revenues generated internationally, potentially impacting future sales and adjusted earnings per share (EPS) [8]. - The company is encountering competitive pressures from firms offering similar pre-analytical solutions, making customer retention challenging [9]. Earnings Estimates - The Zacks Consensus Estimate for QIAGEN's 2025 earnings per share has decreased by 0.9% to $2.26, while the revenue estimate is projected at $2.02 billion, reflecting a 2.1% increase from the previous year [10].

Financial Data and Key Metrics Changes - In Q4 2024, revenue totaled $119 million, representing a 21% year-over-year growth, while full-year revenue reached $446 million, reflecting a robust 23% year-over-year growth [9][32] - Testing revenue, which constitutes nearly 95% of the business, grew by 28% year-over-year [9] - The adjusted EBITDA margin for the full year was 20.6%, with cash generation exceeding $70 million [10][38] Business Line Data and Key Metrics Changes - Decipher testing revenue grew 44% year-over-year in Q4, with volume growth of 36% for the full year [10][33] - Afirma testing revenue increased by 4% year-over-year in Q4, with volume growth of 8% [16][33] - Prosigna revenue decreased by 18% year-over-year due to supply and manufacturing challenges [34] Market Data and Key Metrics Changes - The prostate cancer market is estimated to be approximately 40% penetrated, with the company holding over 65% market share, which increased by more than 500 basis points in 2024 [13] - The endocrinology market is about 65% penetrated, with growth projected in the low-single-digits [19] Company Strategy and Development Direction - The company aims for at least 80% market penetration across all indications, with Decipher being the only gene expression test recommended by the NCCN for personalized treatment decisions in prostate cancer [14] - The company is focusing on international expansion and launching tests as IVDs to meet patient needs outside the U.S. [25] - The NIGHTINGALE study for nasal swab testing has enrolled over 85% of the targeted 2,400 patients, with plans to demonstrate clinical utility [21][98] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of Decipher and Afirma, emphasizing the strong market opportunities and the importance of clinical evidence [55][92] - The company is navigating challenges related to its French subsidiary, which may impact timelines and operations [26][27] - Guidance for 2025 includes testing revenue of $470 million to $480 million, reflecting 12% to 15% year-over-year growth [42] Other Important Information - The company recorded a GAAP net income of $5.1 million in Q4 2024, with a significant tax benefit resulting in a negative effective tax rate [37][39] - The company is considering ceasing funding for its French operations, which may lead to bankruptcy proceedings if a buyer is not found [26][27] Q&A Session Summary Question: How does the company balance investment and margin improvement? - Management highlighted the importance of focusing on core products and long-term growth drivers while managing costs effectively [49][55] Question: What is the expected contribution of Afirma revenue growth? - The guidance for Afirma includes high-single-digit growth, primarily driven by volume rather than pricing [50][59] Question: Can you provide insights on metastatic revenue guidance? - Management indicated that the metastatic indication will have a more significant impact in the second half of the year, with a focus on proper launch and customer education [62][65] Question: What factors are contributing to Decipher's volume growth? - The NCCN guidelines and strong clinical evidence are key contributors to Decipher's growth, with ongoing efforts to generate more evidence [74][80] Question: What is the status of Prosigna and biopharma products? - Management clarified that Prosigna will continue, but its future is dependent on the outcome of the French entity's situation [83][86] Question: What are the potential upside levers for Decipher in 2025? - The company sees significant market opportunity with 60% of the market still unpenetrated, aiming for increased utilization and expansion into new accounts [91][92]