GeneDx (NasdaqGS:WGS) 2025 Conference November 19, 2025 06:00 AM ET Company ParticipantsKatherine Stueland - CEOKevin Feeley - CFOModeratorOkay, we're going to kick it off. I'm Tucker Peterson from the Life Science Team. It's my pleasure to introduce our next company, GeneDx. With us, we have Katherine and Kevin. Welcome to you both. You've had a great year. You've beaten rays each quarter, a number of new indications, multiple newborn screening partnerships, breakthrough device approval, got the guideline ...

Group 1 - The global rare disease patient population exceeds 300 million, with over 6,000 rare diseases identified, yet less than 5% have effective treatments available [1] - Advances in genomics and artificial intelligence are providing new hope for precise diagnosis and treatment of rare diseases [1][2] - The Hong Kong Genome Center has recruited over 53,000 participants since its full operation in 2021, aiming to establish a genomic database primarily for the South China population [1] Group 2 - The Greater Bay Area and Yangtze River Delta regions are witnessing the emergence of local leading companies in cell and gene therapy, such as BGI Genomics and Fosun Kite [2] - A three-year action plan was launched in May to develop common technology platforms in gene editing and organoids, with a special fund of 1 billion yuan to support cross-regional projects [2] - The importance of integrating multi-omics technologies into diagnostic laboratories is emphasized, alongside the need for data sharing and AI technologies [2] Group 3 - Beijing Union Medical College Hospital is enhancing rare disease diagnosis through data sharing and large model technology, significantly improving diagnostic efficiency [3] - The establishment of a national rare disease diagnosis collaboration network and the development of AI-assisted diagnostic tools have been key innovations in improving treatment efficiency [3] - The International Rare Disease Association and the Hong Kong Genome Center co-hosted a conference that attracted nearly 300 medical professionals and researchers from over 20 countries, focusing on clinical genetics, genomics, and data sharing [3]

Core Insights - The research led by the Kunming Institute of Zoology, in collaboration with various domestic and international research institutions, has provided new scientific insights into the evolution, population dynamics, and genetic basis of gibbons, aiding global conservation efforts [2][3]. Group 1: Evolutionary Insights - The study constructed the most comprehensive gibbon genome dataset to date, covering 18 extant gibbon species and successfully obtaining mitochondrial genomes from three ancient samples, including the extinct "Gentle Gibbon" [2]. - The research revealed the evolutionary relationships among the four major genera of the gibbon family, addressing a century-old classification issue and providing a framework for understanding their rapid radiation evolution [2]. - The study confirmed the taxonomic status of the Hoolock gibbon as an independent species and reclassified the "Gentle Gibbon" under the genus Hoolock, correcting previous misconceptions about ancient species classification [2]. Group 2: Population Dynamics - The research reconstructed the population dynamics of gibbons over the past several hundred thousand years, identifying a significant population bottleneck during the Late Pleistocene (approximately 100,000 to 200,000 years ago) followed by a synchronous population recovery around 70,000 years ago [3]. - This population dynamic aligns with global climate changes and sea level fluctuations, indicating that historical climate change has been a key driver of gibbon population fluctuations [3]. Group 3: Genetic Mechanisms of Morphological Traits - The research identified a specific deletion in the regulatory region of the Sonic Hedgehog (SHH) gene, which is crucial for limb development in vertebrates, through comparative genomic analysis [4]. - Functional validation using transgenic mouse models showed that mice carrying the gibbon-specific gene deletion exhibited significantly elongated limb bones compared to wild-type mice, suggesting that this structural variation played a critical role in the evolutionary elongation of gibbon limbs [4].

Core Viewpoint - James Watson, the co-discoverer of the DNA double helix structure and Nobel Prize laureate, passed away at the age of 97, marking the end of an era in molecular biology and genetics [2][3]. Group 1: Contributions to Science - Watson and Francis Crick proposed the DNA double helix model in 1953, which unveiled the secrets of life's genetic code and laid the foundation for modern molecular biology and biotechnology [2][3]. - The DNA double helix is regarded as one of the "three great scientific wonders of the 20th century," alongside Einstein's theory of relativity and Heisenberg's quantum mechanics, signifying a shift in biology from descriptive to molecular science [4]. Group 2: Academic and Professional Achievements - Watson served as a researcher at Harvard University from 1955 to 1956 and was a biology professor from 1956 to 1976, during which he authored "Molecular Biology of the Gene," a textbook that became a cornerstone for generations of biologists, selling over one million copies globally [5]. - As the director of Cold Spring Harbor Laboratory from 1968, Watson transformed the institution into a leading center for molecular biology research and established the "James Watson Scholarship" [5]. Group 3: Legacy and Influence - Watson had a significant impact on the Chinese scientific community, fostering collaborations since the 1980s and promoting academic exchanges in molecular biology [5]. - He expressed pride in witnessing China's emergence as a leader in genomics and aimed to establish a world-class life sciences center in Shenzhen, named after him, to focus on cancer and genetics research [5].

Core Points - The Chinese Ministry of Commerce announced the lifting of the export ban on Illumina, Inc., effective November 10, 2025, after being in place since March 4, 2025. However, Illumina remains on the Unreliable Entities List, requiring government approval for instrument purchases [1][2][3]. Company Focus - Illumina is committed to resolving its status on the Unreliable Entities List and continues to serve customers in China, emphasizing its long-standing partnership in advancing genomics and improving human health [2][3]. Management Response - Jacob Thaysen, CEO of Illumina, expressed satisfaction with the announcement from MOFCOM, viewing it as a positive step forward. The company will maintain engagement with authorities and stakeholders to work towards a long-term resolution [3]. Financial Guidance - Illumina has made no changes to its fiscal year 2025 guidance, which was recently updated during the Q3 2025 earnings call [3]. Company Overview - Illumina is a leader in DNA sequencing and array-based technologies, focusing on innovation to improve human health. Its products serve various applications in life sciences, oncology, reproductive health, and agriculture [4].

Core Viewpoint - Despite the delisting of the first cancer early screening stock in Hong Kong, fund managers are still aggressively purchasing related assets, indicating a strong interest in the cancer early screening sector [1][2]. Industry Overview - Noblue Health, a prominent player in the cancer early screening market, was officially delisted on October 27 due to financial issues and long-term suspension, with its stock valuation adjusted to 0.01 HKD by several public funds [2][3]. - The cancer early screening sector, which integrates genomics and AI medical technology, has gained significant attention from public funds, especially in the context of rising interest in innovative drugs and AI medical assets [2][4]. Market Dynamics - The delisting of Noblue Health has created a scarcity of cancer early screening assets in the Hong Kong market, prompting fund managers to seek alternatives in the U.S. market [4][6]. - Mirxes, a competitor, successfully launched an IPO in Hong Kong, becoming the only cancer early screening stock in the market after Noblue Health's exit [5]. Investment Opportunities - Fund managers are optimistic about the potential of the AI medical sector, with expectations of sustained growth driven by technological advancements and favorable policy support [7][8]. - Investment opportunities in the AI medical sector are identified in three main areas: AI drug development, AI medical applications, and data production and utilization [8].

Core Insights - The 20th International Genomics Conference (ICG) was held in Hangzhou, Zhejiang Province, focusing on the theme "The Future of Omics and Artificial Intelligence (AI)" with over 100 experts from 19 countries participating [1][2] - This year's conference marks the 25th anniversary of the completion of the Human Genome Project, highlighting the transformative impact of genomics technology on fields such as medicine and agriculture [1] - The ICG aims to promote global collaboration in omics research and the bio-industry, serving as a vital bridge for advancing life sciences [1] Industry Developments - Scholars shared insights on various cutting-edge topics, with notable contributions from prominent figures such as Yang Huanming, George Church, and Wang Jian, focusing on the integration of AI with omics and disease prevention strategies [2] - Discussions included the construction of the "Healthy Zhejiang" cohort by Zhejiang University and calls for enhanced international cooperation in the field of genomics [2] - A special "Science Carnival" was organized for youth, aimed at making advanced scientific research accessible and inspiring a passion for scientific exploration among young people [2]

Financial Data and Key Metrics Changes - The fourth quarter revenues were $225 million, with core revenue down 2.9% for the quarter, impacted by foreign currency and discontinued products [19] - Gross margin in Q4 was 41.2%, affected by lower volume, elevated inventory write-offs, and production inefficiencies [23][24] - Adjusted net income for Q4 was $11 million, down from $22 million in the prior year quarter, primarily due to lower adjusted EBITDA [26] Business Line Data and Key Metrics Changes - Food Safety segment revenues were $162 million in Q4, down 3% year-over-year, with a core revenue decline of 1.3% [19] - Animal Safety segment revenues were $64 million, including a core revenue decline of 6.7% compared to the prior year quarter [20] - Genomics core revenue declined low single digits in Q4, reflecting a sequential improvement [20] Market Data and Key Metrics Changes - Core revenue growth in Europe was up mid single digits, while Asia Pacific was down mid single digits [21] - Latin America region saw a mid single digit decline on a core basis, with growth in some product lines offset by declines in others [22] - U.S. and Canada region experienced low single digit growth in food safety core revenue [22] Company Strategy and Development Direction - The company is focused on improving internal processes and managing through current market conditions to capitalize on future opportunities [17] - A targeted improvement plan has been released to manage the transition period effectively [17] - The company is prioritizing pathogen detection and has launched new products to enhance its offerings in the food safety market [10][19] Management's Comments on Operating Environment and Future Outlook - Management noted that end market conditions have worsened, particularly in food safety, due to inflation pressures on food producers [4][5] - The expectation is for revenue in fiscal 2026 to be between $820 million and $840 million, reflecting ongoing market challenges [29] - Management anticipates that gross margin will face headwinds from sample collection and tariffs, but expects improvements in the second half of the fiscal year [30] Other Important Information - The company completed the divestiture of its cleaners and disinfectants business, resulting in approximately $115 million in net proceeds [27] - Free cash flow in Q4 was roughly breakeven, with total capital expenditures declining to $16 million [28] - The company has successfully remediated two Sarbanes-Oxley material weaknesses [31] Q&A Session Summary Question: Why is this the right time to put out guidance with a new CEO? - Management indicated that the guidance reflects a business-as-usual approach and is intended to provide clarity on the upcoming year [37][38] Question: How much of a headwind is built for next year regarding tariffs? - Management confirmed that the $10 million tariff impact is the expected headwind for fiscal 2026 [41] Question: How does the company plan to grow above market despite consumer pressures? - Management highlighted regulatory opportunities and increased testing focus as key growth drivers [44][45] Question: What are the expectations for food safety industry growth? - Management expects food safety testing to grow at a lower rate than historical mid-single digits due to current market conditions [53][54] Question: What is the expected impact of divestitures on operating expenses? - Management noted that most costs associated with divested businesses will go directly with those businesses, with minimal stranded costs remaining [59][60]

Core Viewpoint - The 21st Beijing Conference on Analytical Testing (BCEIA 2025) will be held from September 10 to 12, 2025, at the China International Exhibition Center in Beijing, focusing on the theme "Forty Glorious Years, A New Chapter" to commemorate the 40th anniversary of BCEIA [2][15]. Group 1: Event Overview - BCEIA 2025 will feature nearly a thousand academic reports and over 4,000 domestic and international experts and scholars in attendance [2][5]. - The event aims to showcase the latest achievements in analytical science and instrumentation, focusing on industry hot topics and technological trends [2][5]. Group 2: Academic and Technical Highlights - The conference will include a keynote speech by Academician Jiang Guibin, reviewing the 40-year development of BCEIA and exploring future directions in analytical testing science [5]. - Topics of interest will include genomics, single-cell sequencing, and artificial intelligence, with 18 specialized academic sub-sessions covering key areas such as mass spectrometry, chromatography, and environmental analysis [5][6]. Group 3: Exhibition Details - The exhibition will cover an area of 53,400 square meters, showcasing nearly 10,000 products and attracting over 30,000 professional visitors [10]. - More than 700 renowned companies from home and abroad are expected to participate, displaying cutting-edge analytical instruments, new materials, and innovative applications across various sectors including healthcare, environmental protection, and advanced manufacturing [12][14]. Group 4: Networking and Collaboration Opportunities - The event will host a series of networking activities, including a forum for young scientists and meetings with editors of prestigious journals, aimed at fostering cross-disciplinary innovation and international collaboration [6][12]. - BCEIA 2025 serves as a platform for the integration of analysis testing with key fields such as intelligent manufacturing and biomedicine, emphasizing the importance of machine learning and artificial intelligence in the industry [15][16].

Core Viewpoint - The research highlights the development of a high-throughput and ultra-sensitive single-nucleus ATAC sequencing technology (UUATAC-seq) and a deep learning model (NvwaCE) for predicting regulatory sequences in vertebrates, providing valuable resources for understanding the regulatory language of vertebrate genomes [5][15]. Group 1: Technology Development - The UUATAC-seq technology allows for the efficient construction of chromatin accessibility maps within a single day for a given species [8]. - The NvwaCE model is designed to interpret the "grammar" of cis-regulatory elements (cCRE) and can directly predict cCRE landscapes from genomic sequences with high accuracy [11]. Group 2: Research Findings - The study found that the conservation of regulatory grammar is significantly stronger than that of nucleotide sequences, revealing the sequence basis for cell-type-specific gene expression [6]. - The analysis indicated that differences in genome size among species affect the number of cCREs but not their size [10]. Group 3: Practical Applications - The NvwaCE model accurately predicts the impact of synthetic mutations on lineage-specific cCRE functionality, aligning with quantitative trait loci (QTL) and genome editing results [13]. - A specific gene mutation site (HBG1-68:A>G) was predicted to have curative potential for sickle cell disease, marking the first instance of an AI-designed functional site being validated in human cells [14].