Accessibility StatementSkip Navigation Study shows that rare variants captured by Illumina WGS with DRAGENâ"¢ variant calling explain most of the "missing heritability" in complex human diseases and traits, including those related to blood pressure and cholesterol Results demonstrate the advantages of WGS over WES and genotyping arrays for assessing genetic risk and identifying drug target candidates. SAN DIEGO, Nov. 12, 2025 /PRNewswire/ -- A study published today in Nature, authored by Illumina, Inc. (NAS ...

Core Insights - Illumina Protein Prep is revolutionizing proteomics by providing the broadest coverage of the blood proteome at the lowest cost per protein target, processing over 40,000 samples globally [1][2] - The solution enhances genomic studies with exceptional specificity, sensitivity, and precision, facilitating breakthroughs in various diseases [2][3] - Collaborations with institutions like Genomics England and PRECISE-SG100K are demonstrating the potential of proteomics in advancing research and clinical applications [6][9] Group 1: Product Launch and Impact - Illumina Protein Prep launched globally in September, enabling researchers to process a significant number of samples and generate comprehensive omic data [1] - The Sydney Mass Spectrometry facility is the first in the Asia Pacific region to adopt this technology, successfully conducting experiments that revealed significant biological insights [4][5] - The solution serves as an alternative or complement to mass spectrometry, enhancing researchers' ability to derive transformative insights [3] Group 2: Research Collaborations and Findings - Genomics England's use of Illumina Protein Prep in its 100,000 Genomes Project resulted in a 7.5% increase in disease classification when integrating genomics and proteomics [6] - The PRECISE-SG100K study aims to analyze 10,000 plasma samples to develop a standardized dataset for therapeutic target interrogation [9][10] - These studies highlight the importance of proteomics in understanding disease mechanisms, particularly in underrepresented populations [8] Group 3: Future Directions and Innovations - Illumina is committed to advancing proteomics through AI-driven infrastructure, integrating secondary and tertiary analysis in a single workflow [2] - The company plans to benchmark existing clinical mass spectrometry studies with Illumina Protein Prep to further validate its capabilities [5] - Ongoing collaborations and studies are expected to enhance the quality and depth of insights into genetic variants and protein expression, contributing to drug discovery [8]

Core Insights - Illumina reported Q3 2025 revenue of $1.084 billion, flat year-over-year, slightly above market expectations, with clinical applications driving growth outside of China [1][3] - The company raised its full-year earnings forecast to a range of $4.27 billion to $4.31 billion, an increase of $200 million from previous guidance [12][33] - Illumina's stock surged by 24.76% following the positive earnings report and upward revision of guidance, reversing a downward trend [1][3] Financial Performance - Total revenue: $1.084 billion (year-over-year flat, constant currency flat) [3] - Product revenue: $927 million, up 1.4% year-over-year [3] - Service and other revenue: $157 million, down 5.4% year-over-year [3] - GAAP operating margin: 21.0%, Non-GAAP operating margin: 24.5% [3] - GAAP net income: $150 million, Non-GAAP net income: $206 million [3] - Earnings per share (EPS): GAAP $0.98, Non-GAAP $1.34 [3] - Operating cash flow: $284 million, free cash flow: $253 million [3] - Share repurchase: 1.2 million shares for a total of $120 million at an average price of $97.10 [3] Product and Technology Developments - Illumina launched several new products and technologies, including the 5-base Solution, Constellation Mapped Read, BioInsight, TruSight Oncology Comprehensive, and Illumina Protein Prep [3][4] - The company is extending its strategy from genomic sequencing to multi-omics and proteomics [4] Market and Regulatory Dynamics - The Chinese market is still affected by export restrictions and the "unreliable entity list," but Illumina achieved growth in other regions [5][22] - The company is focused on optimizing global supply and cost structures to mitigate geopolitical risks [5] Detailed Performance Analysis - NovaSeq X platform showed strong performance with over 55 units installed in Q3, aligning with the target of 50 to 60 units per quarter [15][19] - Approximately 78% of testing samples and 51% of revenue were generated through the X platform, indicating a rising conversion rate from NovaSeq 6000 to NovaSeq X [18][25] - Clinical market revenue from sequencing consumables grew at a double-digit rate year-over-year [20] Future Strategy - Illumina's strategic direction includes developing core sequencing business, accelerating X platform transition, and expanding multi-omics [28] - The company has made significant progress in these areas, including the launch of the Illumina Protein Prep product and the establishment of BioInsight for genomic data applications [31][32]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was reported at $1.08 billion, reflecting a year-over-year growth of approximately 2% excluding China, and was above the guidance range [6][18] - Non-GAAP operating margin expanded by 190 basis points to 24.5%, and non-GAAP diluted EPS increased to $1.34, representing an 18% year-over-year growth [18][24] - Greater China revenue was $52 million, with overall revenue growth outside of China being a significant milestone [18][25] Business Line Data and Key Metrics Changes - Sequencing consumables revenue was $747 million, roughly flat year-over-year, but up about 3% excluding China [18][22] - Clinical business saw double-digit revenue growth outside of China, driven by comprehensive genomic profiling and sequencing-intensive applications [18][22] - Research consumable sales declined by high single digits outside of China due to funding uncertainty and pricing dynamics [18][22] Market Data and Key Metrics Changes - The transition to the NovaSeq X platform progressed significantly, with approximately 78% of volumes and 51% of revenue in Q3 being sequenced on X [19][20] - Total sequencing GB output on connected high and mid-throughput instruments grew at a rate of more than 30% year-over-year, primarily driven by clinical demand [21] - The instruments business in Greater China experienced a decline of approximately 54% due to export restrictions [22] Company Strategy and Development Direction - The company is focusing on three strategic pillars: growing the core sequencing business, scaling into multi-omics, and expanding services, data, and software capabilities [9][12] - The launch of Illumina Protein Prep and the five-base solution are part of the strategy to enhance multi-omics capabilities [11][12] - The company aims to achieve high single-digit revenue growth and 20% non-GAAP operating margins by 2027, excluding Greater China [16][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical business as the primary driver of revenue growth, with expectations for a gradual return to growth in the research segment [15][16] - The company remains cautious about the regulatory environment in China but is encouraged by the resilience shown in that market [31] - Management highlighted the importance of customer feedback in shaping future product offerings and maintaining competitive advantage [14][45] Other Important Information - The company has increased its revenue guidance for Greater China by $20 million to approximately $220 million for the year [25] - Non-GAAP operating margin guidance has been raised by approximately 60 basis points to a range of 22.75% to 23% [26] - The company ended the quarter with approximately $1.28 billion in cash and cash equivalents, with plans for continued share repurchases [24] Q&A Session Summary Question: Insights on China and 2026 outlook - Management is pleased with performance in China despite unresolved regulatory issues and is optimistic about customer relationships [30][31] Question: 2026 revenue growth framework - Management acknowledges the potential for low single-digit revenue growth in 2026, driven by clinical growth and muted research revenue [32][34] Question: Margin outlook and operational efficiency - Management is confident in further margin expansion due to disciplined cost management and operational improvements [33][35] Question: Consumables growth and market dynamics - The growth in consumables was primarily driven by clinical demand, with no significant pull forward from academic or government segments [37][38] Question: Competitive landscape and market pressures - Management views competition positively, emphasizing Illumina's multi-dimensional value proposition over single-dimensional competition [44][45] Question: Future instrument placements and market trends - Management expects stable instrument placements moving forward, supported by ongoing demand in clinical and research applications [46][47] Question: Research market dynamics and funding predictability - Management notes that predictability in grant funding is crucial for research spending, with ongoing monitoring of the funding environment [60]

Financial Performance - Illumina's Q3 2025 revenue was $1.08 billion, approximately flat year-over-year in constant currency and reported terms[8] - Non-GAAP operating margin was 24.5%[8] - Non-GAAP diluted EPS reached $1.34, an 18% increase[8, 31] - Free cash flow for Q3 2025 was $253 million[33, 34, 35] Revenue Breakdown - Sequencing consumables revenue was $747 million, a 1% increase[16] - Sequencing instruments revenue was $107 million, a 3% increase[28] - Sequencing service and other revenue was $147 million, a 2% decrease[28] - Revenue excluding Greater China grew by approximately 2% year-over-year in constant currency[8] Regional Performance - Americas revenue was $612 million, a 1% increase[8] - Europe revenue was $309 million, a 6% increase[8] - AMEA (Asia Pacific, Middle East and Africa) revenue was $111 million, a 6% increase[8] - Greater China revenue was $52 million, a 31% decrease[8] NovaSeq X Transition - Over 50% of high-throughput revenue was attributed to NovaSeq X[8, 13, 21] - Over 75% of high-throughput gigabases shipped were attributed to NovaSeq X[13, 21] FY25 Guidance - Illumina anticipates full year 2025 revenue growth between 0% and 1% for the rest of the world and between -1.5% and -0.5% for Greater China[37] - The company projects full year revenue between $427 billion and $431 billion[37]

Core Insights - Illumina has launched a novel 5-base solution that enhances multiomic analysis, allowing simultaneous detection of genomic variants and DNA methylation from a single sample, which is expected to advance precision medicine [1][2][3] Product Features - The 5-base solution utilizes proprietary 5-base chemistry and DRAGEN algorithms, providing high-resolution insights into both the methylome and genome while reducing complexity and cost [1][2][3] - Customers can choose between two kits: Illumina 5-Base DNA Prep for whole-genome coverage and Illumina 5-Base DNA Prep with Enrichment for targeted genomic regions, both capable of detecting DNA methylation at single-base resolution [4][5] - The library preparation and sequencing of these kits are compatible with Illumina NovaSeq Systems and NextSeq 2000 System, enabling simultaneous methylation profiling and genomic variant calling [5] Research Applications - The 5-base solution is being applied in various research areas, including oncology and rare diseases, and is expected to provide deeper insights into disease mechanisms and biomarker discovery [3][6][7] - Bekim Sadikovic from the London Health Sciences Centre Research Institute is among the early testers, highlighting the potential of the 5-base technique to enhance the understanding of functional genomics in rare diseases [6][7][8] Industry Impact - Illumina's advancements in multiomics technology are positioned to transform the landscape of genomic research and drug development, unlocking new avenues for discovery [5][9]

Core Insights - Illumina, Inc. (ILMN) is partnering with global pharmaceutical companies to develop companion diagnostics (CDx) based on the TruSight Oncology (TSO) Comprehensive genomic profiling test, focusing on KRAS alterations linked to cancer growth [1][10] Company Developments - The expansion of tumor-agnostic CDx claims demonstrates Illumina's commitment to enhancing patient access to precision oncology through standardized tests [2] - Illumina's TSO Comprehensive generates molecular tumor profiles to assist clinicians in matching patients with targeted therapies based on genetic mutations [3][10] - The development of CDx claims for KRAS will facilitate broader identification of patients who may benefit from targeted therapies, irrespective of tumor origin [6] Industry Context - The global CDx market was valued at $9.06 billion in 2024, with a projected compound annual growth rate of 10.5% through 2030, driven by the increasing prevalence of cancer and the demand for targeted therapies [7][8] - The integration of CDx into drug development pipelines by pharmaceutical companies is expected to enhance the success rate of novel therapeutics, further propelling market growth [8] Technological Advancements - Illumina introduced the Illumina Protein Prep, an assay that enhances next-generation sequencing (NGS)-based proteomics discovery, capable of measuring 9,500 unique human protein targets [9]

Core Insights - PacBio (PACB) has entered the high-throughput carrier screening market with its expanded PureTarget portfolio, utilizing HiFi sequencing technology to streamline genetic testing into a single scalable assay [1][3][6] Company Developments - The updated PureTarget panels can process up to 100,000 samples annually on a single Revio system, making them suitable for various applications, including clinical programs and national initiatives [2][4] - The new offering addresses the bottleneck of fragmented tests for analyzing difficult hereditary genes, enhancing efficiency and reducing costs for laboratories [3][4] - PacBio's PureTarget panels are available in flexible kit formats (24 and 96-sample kits) tailored for reproductive health and neurological disease, allowing profitable high-throughput programs within existing reimbursement structures [5][9] Industry Prospects - The global carrier screening market was valued at $1.2 billion in 2022 and is projected to grow at a CAGR of 12.4% from 2023 to 2030, driven by increasing demand for genetic testing [7][8] - Government and private sector investments are expected to further propel market expansion, with a focus on cost-efficient technologies and innovative tests [8]

Company Overview - Illumina, Inc. (ILMN) has entered into a definitive agreement to acquire SomaLogic for $350 million in cash, with potential additional payments of up to $75 million based on performance milestones and royalties [1][9] - The acquisition aims to enhance Illumina's position in the growing proteomics market and support its multiomics strategy announced last year, with the deal expected to close in the first half of 2026 [2][9] Financial Performance - Illumina currently has a market capitalization of $14.49 billion and an earnings yield of 4.6%, significantly higher than the industry's -27.7% yield [4] - The company has consistently beaten earnings estimates, achieving an average earnings beat of 56.4% over the past four quarters [4] Strategic Importance of Acquisition - The acquisition builds on a previous co-development agreement with SomaLogic, which focuses on integrating the SomaScan Proteomics Assay into Illumina's high-throughput next-generation sequencing platforms [5] - SomaLogic's technology is recognized for its scalability and reproducibility, allowing researchers to gain significant insights with high sensitivity and throughput [5] Market Prospects - The global proteomics market is projected to reach $41.65 billion by 2025, growing at a compound annual growth rate (CAGR) of 14.9% by 2034, driven by ongoing R&D and the demand for personalized medicine [11] - Illumina expects the SomaLogic business to become profitable by 2027, with strong non-GAAP margin potential aligning with Illumina's margins by 2028 [9][10] Stock Performance - Following the acquisition announcement, ILMN shares increased by 2.9%, closing at $93.23, and have risen 14% over the past month compared to the industry's 2.5% growth [3][13]

Core Insights - Illumina announced the acquisition of SomaLogic for $350 million in cash, aimed at enhancing its position in the growing proteomics market and accelerating its multi-omics strategy for 2024 [1][3] - The acquisition is based on a prior collaboration established in December 2021, focusing on integrating SomaLogic's protein detection technology into Illumina's NGS platform [3][4] - The global proteomics market is projected to grow from $33.6 billion in 2024 to $60.5 billion by 2029, with a compound annual growth rate (CAGR) of 12.4% [9] Company Strategy - Illumina's CEO stated that the acquisition will enhance the value of the NovaSeq X product and unlock greater potential for future advancements [3] - The integration of SomaLogic's technology with Illumina's scalable NGS platform and analysis software is expected to accelerate technological development in proteomics and reduce research time and costs [3] - The company aims to complete the acquisition by mid-2026, pending regulatory approvals, while both companies will continue to operate independently until then [4] Market Context - Illumina holds over 80% of the global gene sequencing market but has faced revenue declines and significant losses, particularly a projected loss of $1.223 billion in 2024 [6] - The company has been impacted by being placed on the "unreliable entity list" in China, affecting its business in the Greater China region [6] - The competitive landscape is intensifying, with rivals like Roche Diagnostics and BGI encroaching on Illumina's market share [6] Industry Trends - The proteomics field is seen as a critical area for future diagnostics and drug development, with the potential to discover new biomarkers and therapeutic targets [7] - Recent acquisitions in the proteomics space, such as Thermo Fisher's $3.1 billion purchase of Olink Holding AB, indicate a growing interest and investment in this sector [10] - Illumina's acquisition of SomaLogic is expected to strengthen its capabilities in the high-growth proteomics market, with profitability anticipated by 2027 [10]