Gene and cell therapy

“Andel af samlet omsætning Hidtil er det især udviklingen inden for celle- og genterapi, der har drevet ChemoMetecs fremgang på LCB-markedet. Celle- og genterapi er en forholdsvis ny behandlingsform med potentiale til at behandle mange sygdomme, som i øjeblikket ikke kan behandles, eller hvor behandlingen ikke er særlig effektiv.”

Annual report 2025A · The company itself

“Markedsanalyser viser samtidig, at der er en stærk pipeline af forsøg inden for celle- og genterapi, og at stadig flere behandlinger bliver godkendt og kommer i produktion. På den baggrund ser vi positivt på det langsigtede potentiale inden for celle- og genterapi – og dermed også på ChemoMetecs muligheder for at skabe fortsat vækst i alle faser fra udvikling til produktion og automatisering inden for dette område.”

Annual report 2025A · The company itself

“Valideringsprocesserne hos kunderne er dog typisk langvarige, og det forventede store potentiale for ChemoMetec inden for bioprocessing og automatisering af produktionen inden for celle- og genterapi vil derfor først udfolde sig over nogle år.”

Annual report 2025A · The company itself

“Xcyto 5 adresserer både markedet for celle- og genterapi og bioprocessing.”

Annual report 2025A · The company itself

“NC-203 er en opgraderet version af NC-202, og instrumentet anvender ligesom NC-202 engangskassetter og har derudover fået overført en del ny teknologi fra XcytoMatic-platformen. Opgraderingen omfatter primært et nyt målemodul, en ny softwareplatform samt anvendelsen af kontrast-mikroskopi kombineret med AIbaseret billedanalyse.”

Annual report 2025A · The company itself

“Xcyto 5 XM50 er en fuldautomatisk celletæller, der er bygget på samme teknologiske platform som XM30 og XM40. XM50 modtager en mikroplade med prøver og kan analyse op til 96 prøver ad gangen.”

Annual report 2025A · The company itself

“Udviklingen af det nye instrument forløber som planlagt, og det forventes, at de første salg af XM50 vil ske i Ledelsens beretningꢀ|ꢀFinansiel redegørelse Årsrapport 2024/25ꢀ|ꢀChemoMetec 36 Finansiel redegørelse Udvikling i omsætningen Omsætningen af instrumenter steg i 2024/25 med 22%, mens omsætningen af forbrugsvarer og serviceydelser steg med henholdsvis 20% og 25%.”

Annual report 2025A · The company itself

“Kunder og markeder Innovation og produktion • Lancering af XcytoMatic 50 og andre produkter til automatisering inden for celle- og genterapi. • Bredere lancering af celletællerne XcytoMatic 30 og XcytoMatic 40, der er målrettet bioprocessingmarkedet samt automatiserings-kunder inden for celle- og genterapi. • Udvikling af XcytoMatic 50 og Sample Management System. • Udvikling af software og andre produkter, der kan bidrage til automatisering og effektivisering hos kunderne, der typisk er underlagt høje krav til dokumentation og kvalitetskontrol. • Øget salg af eksisterende servicepakker og udvikling af nye serviceydelser til både nye og eksisterende produkter. • Øget salg til eksisterende kunder samt afdækning af deres behov inden for automatisering. • Udvikling af komplette løsninger til nye og eksisterende kunder. • Yderligere opskalering og effektivisering af produktionen samt indkøring af nye produkter i produktion.”

Annual report 2025A · The company itself

“ChemoMetec er i fuld gang med lanceringen af de nye XcytoMatic-produkter, og i det kommende regnskabsår vil aktiviteterne på denne front blive yderligere intensiveret. Med de nye XcytoMatic-instrumenter har vi opnået en væsentlig styrkelse af vores samlede produktportefølje, hvilket forventes at styrke vores muligheder for at skabe vækst på både kort og længere sigt.”

Annual report 2025A · The company itself

“NC-200 finder primært anvendelse inden for celle- og genterapi, og analysetiden er omkring 45-50 sekunder.”

Annual report 2025A · The company itself

“Ligesom NC-200 finder NC-202 hovedsagelig anvendelse inden for celle- og genterapi.”

Annual report 2025A · The company itself

“Den målrettede indsats over en årrække har betydet, at ChemoMetec er lykkedes med at opbygge en meget attraktiv position inden for dette område, hvor der er behov for celletælling i hele forløbet fra udviklingsfasen og frem til produktionen af den konkrete behandling til patienterne.”

Annual report 2025A · The company itself

“Det er især de mindre kunder inden for celle- og genterapi, som bliver påvirket af den øgede usikkerhed, og hermed typisk kunder med udviklingsprojekter i de tidligere forsøgsfaser (kunder der typisk køber vores NucleoCounter-produkter).”

Annual report 2025A · The company itself

“Modsat påvirkes de større kunder inden for bioprocessing og kunder med automatiseringsprojekter inden for celle- og genterapi (kunder der typisk køber vores nye XcytoMatic-produkter) ikke i særligt omfang af udsving i markedsforholdene, og de har generelt gode muligheder for at tiltrække kapital til deres projekter.”

Annual report 2025A · The company itself

“krafterna för innovation inom genetisk testning är över - gången från att analysera enskilda kromosomer till sekvensering av hela genomet. Tekniska framsteg har gjort det allt mer kostnadseffektivt och praktiskt att sekvensera hela individens genom inte bara på patientnivå utan också på embryonivå.”

Annual report 2024A · The company itself

“Utveckla vår portfölj för genetisk testning för bättre behandlingsresultat Genetisk testning har gjort det möjligt för oss att avsevärt förbättra behandlingsresultaten och vi är på väg att kunna utnyttja dess fulla potential.”

Annual report 2024A · The company itself

“Genetic Services och genetiska testkit för att begränsa effekterna av insourcing och maxi - mera marknadsandelen för preimplantatorisk genetisk testning (PGT). Vi kan därmed skapa en sammanhållen och synergisk marknadsstrategi.”

Annual report 2024A · The company itself

“Vitrolife Group är en internationell koncern för medicintekniska produkter och genetiska tester inom reproduktion.”

Annual report 2024A · The company itself

“Responsible and ethical business practices 2025 ✓ 2024 2023 Number of whistleblower cases 0 0 0 Number of convictions for violation of anti-corruption and anti-bribery laws 0 0 0 Amount of fines for violation of anti-corruption and anti-bribery laws (EUR) 0 0 0 Number of confirmed incidents of corruption or bribery 0 0 0 Number of confirmed incidents in which own workers were dismissed or disciplined for corruption or bribery-related incidents 0 0 0 Number of confirmed incidents relating to contracts with business partners that were terminated or not renewed due to violations related to corruption or bribery 0 0 0 ✓ Subject to Limited Assurance As a biotech company with a strong focus on R&D, protecting intellectual property (IP) is crucial for driving innovation and staying competitive. Misuse of IP and challenges in defending IP can negatively impact our business and our ability to develop new treatment possibilities to meet unmet medical needs of patients.”

Annual report 2025A · The company itself

“Efterfrågan ökade på traditionella laboratoriereagenser samt produkter för gensekvensering, cellterapi och cancerimmunologi, samt instrumentering. Labtechs produktportfölj utvecklas kontinuerligt mot mer avancerade produkter och inom gensekvensering lanserades Next Generation Sequencing (NGS) under året i både Italien och Skandinavien.”

Annual report 2023A · The company itself

“Inom affärsenheten Biomedical and Research har AddLife identifierat bland annat molekylärbiologi samt avancerade instrument för laboratorieanalys som tillväxtsegment.”

Annual report 2023A · The company itself

“We provide active pharmaceutical ingredients for oligo-based therapeutics as well as solutions that include reagents, instruments, software and consumables, which enable customers in the clinical and life sciences research areas to interrogate samples at the cellular and molecular level.”

Annual report 2025A · The company itself

“Sixth, our genomics business includes reagents to support next-generation sequencing workflows and arrays. This business also includes solutions that enable clinical labs to identify DNA variants associated with genetic disease and help direct cancer therapy.”

Annual report 2025A · The company itself

“Finally, our biomolecular analysis business provides complete workflow solutions, including instruments, consumables and software, for quality control analysis of nucleic acid samples. Samples are analyzed using quantitative and qualitative techniques to ensure accuracy in further genomics analysis techniques including next-generation sequencing, utilized in clinical and life science research applications.”

Annual report 2025A · The company itself

“Genomics We provide a next-generation sequencing target enrichment portfolio which enables customers to select specific target regions of the genome for sequencing. Customers can customize our products for their regions of interest including gene panels for specific applications and exome designs, which allow analysis of the entire coding sequences of the genome.”

Annual report 2025A · The company itself

“Our primary focus is on biopharmaceutical companies working with advanced therapeutic modalities (e.g., cell and gene therapies) where we provide a suite of research tools and companion diagnostic development services. Additionally, we provide active pharmaceutical ingredient contract development and manufacturing services for oligonucleotide-based therapeutic modalities.”

Annual report 2025A · The company itself

“The focus on becoming an attractive partner within biomanufacturing has demanded investments in the establishment of a DMF (Drug Master File) as well as a GMP upgrades for the Company’s SAN portfolio. By H2 2025, the Company will be uniquely positioned as provider of specialized GMP and non-GMP enzymes optimized for the two major classes of gene therapies—AAV and Lenti-virus. These enzymes will also support other biologics, such as viral vaccines, establishing a critical foundation for revenue growth in 2025 and beyond.”

Annual report 2024A · The company itself

“Our Salt Active Nuclease (SAN) program remained a key priority. We made strong progress toward launching a comprehensive GMP-grade nuclease portfolio by mid- 2025. This will uniquely position ArcticZymes to support gene therapies—AAV and Lentivirus—as well as broader biologics like viral vaccines.”

Annual report 2024A · The company itself

“Biomanufacturing ArcticZymes is serving customers with Salt Active Nuclease (SAN) products who are in different stages of therapeutic or vaccine development. The SAN portfolio of enzymes is used for removing non-encapsulated nucleic acid impurities from therapeutic viruses such as Adenovirus, Adeno-Associated Virus (AAV), and Lentivirus. This reduces the risk of adverse effects in the final vaccine product.”

Annual report 2024A · The company itself

“In 2024, ArcticZymes has continued to prioritize organic growth initiatives, making significant strides in its SAN (Salt Active Nuclease) program to achieve a comprehensive GMP nuclease portfolio. • Cell biology/Cell therapy: proteolytic enzymes such as ArcticZymes’ Proteinase represent essential tools for the dissociation and isolation of cells from patients for ex vivo manipulation and treatment. • RNA Therapeutics: The Coronavirus pandemic demonstrated the commercial utility and acceptance of mRNA technology as a therapeutic tool in rapid vaccine manufacturing effective and safe RNA-based vaccines. mRNA technology represents a powerful technology that can be extended to the development of other vaccines or gene therapy applications. Unlike viral vector manufacturing, multiple enzymes are required to manufacture therapeutic mRNAs where the need for novel and high-quality enzymes is in high demand.”

Annual report 2024A · The company itself

“The Company also expanded efforts in genomic medicine and cell therapy including the highly competitive acquisition of EsoBiotec.”

Annual report 2025A · The company itself

“Affärsområdet Bioprinting har en differentierad roll i portföljen och skapar möjligheter för framtidens labb.”

Annual report 2024A · The company itself

“LEQEMBI is in the early stages of commercial launch in the U.S. and certain international markets and SKYCLARYS is in the early stages of commercial launch in certain European markets.”

Annual report 2025A · The company itself

“We are a leader in distribution and services to health systems, community oncologists, and retina specialists and have leading positions in other physician-administered products. We distribute plasma and other blood products, injectable pharmaceuticals, vaccines, and other specialty products. We are well positioned to service and support biotechnology therapies and advanced technologies such as cell and gene therapies.”

Annual report 2025A · The company itself

“The fully integrated advanced therapeutics portfolio enables us to provide clients with an integrated solution from analytical and process development through cGMP production; driving efficiency and accelerating clients’ speed-to-market by integrating preclinical CRO activities with manufacturing and testing. This provides our clients with a seamless experience across the value chain with the same advanced therapeutics scientific partner.”

Annual report 2025A · The company itself

“We have extensive expertise in the discovery of clinical candidates and in the design, execution and reporting of safety assessment studies for numerous types of therapeutic modalities, including cell and gene therapies, small and large molecule pharmaceuticals, industrial and agricultural chemicals, vaccines, consumer products, veterinary medicines, biocides and medical devices.”

Annual report 2025A · The company itself

“Certain strains of our research models are proprietary rodent models used to research treatments in several therapeutic areas.”

Annual report 2025A · The company itself

“We create, breed and maintain research models required by our clients for biomedical research activities.”

Annual report 2025A · The company itself

“Cell Solutions. Our Cell Solutions business provides consenting human donor-derived cellular materials used in the development and production of cell therapies.”

Annual report 2025A · The company itself

“Additionally, we support safety studies in numerous specialty areas including cell and gene therapies, ecotoxicology, environmental risk, musculoskeletal toxicology, neurotoxicology, ocular toxicology, ototoxicology, and phototoxicology.”

Annual report 2025A · The company itself

“Our Biologics Solutions (Biologics) business is comprised of our Biologics Testing Services business and CDMO business. Biologics Testing Services Our Biologics Testing Services business provides clients with analytical testing and related capabilities to support the safe manufacture of their biologic drugs, as well as a suite of manufacturing services to produce our clients’ advanced therapeutics.”

Annual report 2025A · The company itself

“CDMO Services Our CDMO business operates in the three major areas of the high-growth advanced therapy CDMO market: cell therapy, viral vector, and plasmid DNA production. Our CDMO services include expertise in gene-modified and unmodified cell therapy manufacturing coupled with capabilities in viral vector manufacturing, as well as plasma DNA.”

Annual report 2025A · The company itself

“Our comprehensive cell and gene therapy manufacturing services include Good Manufacturing Practices (GMP) production of cells from pre-clinical to commercial applications from a variety of starting materials.”

Annual report 2025A · The company itself

“During the fourth quarter ended December 27, 2025, prior to the annual Goodwill Impairment Assessment, a triggering event was identified for the Cell Solutions, CDMO Cell Therapy, and CDMO Gene Therapy asset groups due to a decline in operating performance in fiscal 2025, ultimately resulting in a reduction in the asset groups’ long range financial outlook, and evolving market information about these asset groups identified in the fourth quarter of 2025. Cell Solutions is presented within the RMS reportable segment, while CDMO Cell Therapy and CDMO Gene Therapy are presented within the Manufacturing reportable segment.”

Annual report 2025A · The company itself

“Research Models includes the commercial production and sale of small research models, as well as the supply of large research models. Research Model Services includes: Insourcing Solutions (IS), which provides colony management of our clients’ research operations (including recruitment, training, staffing, and management services) within our clients’ facilities as well as our own vivarium space, utilizing our Charles River Accelerator and Development Lab (CRADL™) offerings, Genetically Engineered Models and Services (GEMS), which performs contract breeding and other services associated with genetically engineered models; and Research Animal Diagnostic Services (RADS), which provides health monitoring and diagnostics services related to research models; and Cell Solutions, which provides controlled, consistent, customized primary cells and blood components derived from normal and mobilized peripheral blood and bone marrow as well as cells from disease state donors.”

Annual report 2025A · The company itself

“Life Sciences Segment As a leading developer, manufacturer and global supplier of laboratory products for over 110 years, the Life Sciences segment works with researchers and drug manufacturers seeking to drive innovation, increase efficiencies, reduce costs and compress timelines. Using unique expertise in the fields of materials science, polymer surface science, cell culture and cell biology, the segment provides innovative solutions that improve productivity and enable breakthrough research for traditional small molecule, or chemical, drugs, biologics, vaccines and emerging cell and gene therapies.”

Annual report 2025A · The company itself

“BIOTECHNOLOGY The Biotechnology segment offers a broad range of equipment, consumables, software and services that are primarily used by customers to advance and accelerate the research, development, manufacture and delivery of biological medicines. The Company’s solutions support a broad range of biotherapeutics including monoclonal antibodies, recombinant proteins, replacement therapies such as insulin and vaccines, as well as novel cell, gene, mRNA and other nucleic acid therapies.”

Annual report 2025A · The company itself

“The bioprocessing business is a leading provider of technologies, consumables, services and solutions that advance, accelerate and integrate the development and manufacture of therapeutics. These therapeutics include protein-based and other biological therapies as well as a new emerging class of highly-targeted therapies such as cell and gene therapies and nucleic acid-based therapies.”

Annual report 2025A · The company itself

“The life sciences consumables business bridges the gap between research and practical application, enabling the discovery, development, and manufacture of new therapies. The business provides consumables and services including antibodies and assays to accelerate scientific research, plasmid DNA, RNA, critical nucleic acids and proteins used to develop and manufacture gene and cell therapies, and analytical tools and services to accelerate discovery, clinical applications and manufacturing for therapies across pharmaceutical, biopharmaceutical, diagnostic and emerging biotechnology companies, research institutions and universities.”

Annual report 2025A · The company itself

“PRODUCT DEVELOPMENT Amarna Therapeutics AnaCardio Innovativa och potentiellt botande genterapier för såväl sällsynta som vanligt förekommande sjukdomar, med initial inriktning på typ 1-diabetes. Nya läkemedel utvecklade för att adressera ett underliggande problem vid hjärtsvikt – försämrad kontraktilitet – baserat på banbrytande forskning från Karolinska Institutet.”

Annual report 2024A · The company itself

“Fokuserade på att prioritera värdeskapande projekt Hansas mission är att utveckla innovativa immunmodulerande behandlingar med potential att förändra livet för människor som lider av immunmedierade sjukdomar. Vi fokuserar för närvarande på patienter som lever med immunmedierade sjukdomar och -tillstånd, inom områdena autoimmunitet, genterapi och transplantation.”

Annual report 2024A · The company itself

“•Specialty Testing Services: Gene‑based and esoteric testing using advanced technologies to target specific diseases, including services in anatomic pathology/oncology, cardiovascular disease, coagulation, diagnostic genetics, endocrinology, infectious disease, women’s health, pharmacogenetics, parentage and donor testing, occupational testing services, medical drug monitoring, chronic disease programs, and kidney stone prevention. •Health and Wellness Services: Testing and related services provided to consumers, employers, and managed care organizations, including health fairs, on‑site and at‑home testing, vaccinations, and health screenings.”

Annual report 2025A · The company itself

“Our Oncology & Multispecialty segment includes provider solutions that encompass specialty drug distribution, group purchasing organizations, infusion services, direct to patient pharmacy capabilities, InspiroGene™ cell and gene therapy services, technology solutions, practice consulting services, and vaccine distribution.”

Annual report 2026A · The company itself

“Optomed toimii globaaleilla silmien tutkimus- ja hoitolaitteiden markkinoilla, jotka sisältävät silmäpohjakameroita, niihin liittyviä ohjelmistoja sekä tekoälyratkaisuja silmäsairauksien seulontaan.”

Annual report 2025A · The company itself

“With a strong foundation and significant expertise in life sciences, PMI has a long-term ambition to expand into wellness areas. The business strategy of our wellness unit, Aspeya, currently focuses on developing and commercializing primarily oral consumer wellness offerings. This includes medical and non-recreational cannabinoid products (including CBD), in line with applicable regulatory requirements, though any revenue related to cannabinoids is expected to be negligible in the near to medium term.”

Annual report 2025A · The company itself

“Table of Contents Regeneron Genetics Center® Regeneron Genetics Center LLC (RGC®), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, proteomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patient's privacy while uncovering the unique characteristics of their health and wellness. The objective of RGC is to expand the use of human genetics for discovering and validating genetic factors that cause or influence a range of diseases where there are major unmet medical needs, with the prospect of improving the drug discovery and development process and to advance innovation in clinical care design.”

Annual report 2025A · The company itself

“In addition, we may need to develop or acquire additional manufacturing capabilities as we and/or our collaborators continue to pursue the development of drugs generated by means other than our established "Trap" or VelociSuite technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression.”

Annual report 2025A · The company itself

“Table of Contents Principal Products: Our principal products and services for Life Sciences applications include the following: •Reagents ◦Radiometric detection solutions, including over 750 radiochemicals for use with our liquid and plate-based analyzers, and utilized in research, environmental and drug discovery applications. ◦Reagents and solutions for microscopy and imaging applications. These include PhenoVue® cellular imaging reagents and cell painting kits, PhenoPlate™ (formerly CellCarrier Ultra™) cellular imaging microplates and GrowDex™ hydrogels, fluorophore-conjugated and enzyme-conjugated antibodies, as well as buffers and solutions, such as our Ce3D™ collection of buffers for 3D tissue imaging. ◦A wide range of homogeneous biochemical and cell-based reagents using HTRF®, LANCE® Ultra™, DELFIA®, AlphaLISA®, AlphaLISA® SureFire® Ultra™, AlphaScreen®, and AlphaPlex® luminescence assay technologies that can be paired with our microplates, which cover a variety of applications.”

Annual report 2025A · The company itself

“◦New assay kits for Adeno-associated Virus Vectors (AAVs) and gene therapy applications in our range of HTRF® and AlphaLISA® reagents, for detecting and quantifying CHO HCP impurities in biotherapeutics development, as well as kits across oncology, neuroscience, and targeted protein degradation applications. ◦A broad portfolio of recombinant GPCR and ion channel cell lines, including over 300 products and 120 ready-to-use frozen cell lines for a wide range of disease areas. ◦Dharmacon® reagents and gene modulation technologies such as RNAi that support drug discovery and development for greater understanding of gene function, identifying genetic drivers behind human disease, developing and validating diagnostic workflows, and helping deliver biotherapeutics, cellular and gene therapies for precision medicine with a portfolio of cell engineering tools.”

Annual report 2025A · The company itself

“These products serve several markets, notably cell and gene therapy applications. ◦BioLegend® MojoSort™ magnetic bead-based reagents for cell isolation with handheld magnets, as well as MojoSort on Columns™, which uses multistands, columns, and separators for cell sorting.”

Annual report 2025A · The company itself

“◦The high-throughput, microwell Celigo® image cytometry system, the Cellaca® MX high-throughput cell counter, and the Cellometer® automated cell counters, complemented by consumables and reagents, including reagents and kits for cell counting assays and cell viability, microplates, slides, and counting beads. ◦The Cellaca® PLX™ image cytometry system combines best-in-class image cytometer hardware, software, validated consumables and optimized reagent kits with validated antibodies from our BioLegend business, and trackable data reporting to enable the simultaneous detection of multiple markers and to streamline cell and gene therapy workflows. ◦The Cellometer® Ascend™ automated cell counter accelerates lab workflow by reducing human error, all while providing a consistent, standardized cell count. Incorporated with its user-friendly Matrix™ software, this product performs an automated and sophisticated image analysis workflow that delivers reliable results in seconds.”

Annual report 2025A · The company itself

“Table of Contents •Technology and Licensing ◦The Pin-point® base editing platform, a CRISPR-Cas9-based technology that allows researchers to make precision base changes in genomic DNA. Editing with such precision can be used to silence disease-causing genes, correct disease-associated mutations, and optimize cell therapies. ◦The CHOSOURCE® expression platform, a robust CHO expression system for the development and manufacturing of biotherapeutics with a track record of over 100 regulatory filings in multiple countries. ◦Gene Delivery services and technologies to design and manufacture viral vectors for cell and gene therapy research and preclinical development.”

Annual report 2025A · The company itself

“This includes the LentiBOOST® transduction enhancer technology for improved lentiviral transduction efficiency, helping to reduce the cost of goods for cell therapies. ◦Preclinical services for oncology, leveraging capabilities such as cell panel screening, cell line engineering, functional genomic screening, and immune cell screening, for a range of applications to help accelerate the drug development process.”

Annual report 2025A · The company itself

“Diagnostic labs use our instruments, reagents and software for testing and screening genetic abnormalities and certain disorders and diseases, including Down syndrome, hypothyroidism, muscular dystrophy, infertility and various metabolic conditions. We also develop technologies that enable and support genomic workflows using PCR and next-generation DNA sequencing for applications in oncology, immunodiagnostics and drug discovery.”

Annual report 2025A · The company itself

“◦ViaCord® umbilical cord blood banking services for the banking of stem cells harvested from umbilical cord blood and cord tissue, for potential therapeutic application in transplant and regenerative medicine. ◦CD34+ hematopoietic stem cells from human umbilical cord blood (for research use only and not for use in diagnostic procedures). ◦Revvity Omics global laboratory network offers multi-OMIC clinical grade services for testing over an individual’s lifetime (prenatal to adults) in cytogenetics, biochemical genetics, molecular genetics and immunodiagnostics.”

Annual report 2025A · The company itself

“The laboratory network includes testing laboratories in the United States, India, China and the United Kingdom. ◦Revvity Omics® labs utilize next-generation sequencing to provide testing solutions including but not limited to whole genome sequencing, whole exome sequencing, curated and customized gene panels. ◦Revvity Omics® whole genome sequencing test provides dual genome analysis (nuclear and mitochondrial) detecting single nucleotide variants, chromosomal and intragenic copy number events, short tandem repeats analysis for >30genes and SMN1 copy number characterization. This test also provides additional findings like pharmacogenomic analysis and carrier status among others.”

Annual report 2025A · The company itself

“◦Ultrarapid™ whole genome sequencing test, a variant of the whole genome sequencing (WGS) analysis, which bundles the StepOne™ biochemical profile, cCMV analysis and metagenomic analysis with the standard WGS analysis to help babies in the NICU with a result as fast as five days. ◦Using WGS as a backbone, Revvity Omics provides two unique products, the CNGnome® NGS array and WholePanel™ test. Utilizing the uniform coverage across genome, the CNGnome NGS array is used to detect copy number events over 25kb in size, making this as a new gold standard in CNV detection. The WholePanel™ test provides enhanced coverage including the intronic regions for the expertly curated WholeCancer™, WholeAtaxia™, WholeCardiology™ and WholeMuscularDystrophy™ gene panels. •Immunodiagnostics ◦The chemagic® Prime™ instrument is a fully automated, LIMS-compatible solution for primary sample transfer, DNA and RNA isolation, to normalization and the setup of PCR and Next Generation Sequencing (“NGS”) applications.”

Annual report 2025A · The company itself

“Samarbete med en forskningsgrupp från University of Cambridge och University College London (UCL) för en studie som undersöker möjligheten att använda mobilens sensordata för att analysera navigationsoch sömnmönster för att underlätta tidig upptäckt av Alzheimers sjukdom.”

Annual report 2024A · The company itself

“Further, we may face additional challenges identifying and enrolling sufficient patients for clinical trials for rare diseases and cell and gene therapies due to small patient populations.”

Annual report 2025A · The company itself

“Compliance with the regulatory requirements for biologics and cell and gene therapies can be more burdensome, expensive and time-consuming than for other, better known or more extensively studied types of medicines, such as small molecules.”

Annual report 2025A · The company itself

“The commercialization of cell and genetic therapies involves processing more personal data than traditional therapies, increasing our risk exposure.”

Annual report 2025A · The company itself

“The processes for biological and cell and genetic therapies can be more complex than those required for small molecule drugs and require additional investments in different systems, equipment, facilities and expertise.”

Annual report 2025A · The company itself

“We are making investments to enhance the CASGEVY manufacturing process, to secure additional capacity, and to coordinate manufacturing, testing, and logistics activities at a larger scale across multiple facilities to serve the geographies in which we are treating and expect to treat additional people with CASGEVY.”

Annual report 2025A · The company itself

“In addition, we have established cell therapy manufacturing capabilities at our facilities in the Boston area to supply clinical and potentially commercial quantities of our cell therapies as our needs evolve, including our plans to utilize our own manufacturing capabilities in Boston for additional commercial supply of CASGEVY.”

Annual report 2025A · The company itself

“To further expand our ability to supply clinical and potentially commercial quantities of our cell therapies, we have a strategic agreement with Lonza to support the manufacture of T1D cell therapy product candidates.”

Annual report 2025A · The company itself

“(in millions, except percentages) Research Expenses: Salary and benefits $203.9 (3)% $210.7 14% $184.1 94.8 (15)% 112.1 21% 92.4 Outsourced services and other direct expenses 286.2 5% 271.4 15% 237.0 Infrastructure costs 243.0 16% 210.3 9% 192.1 Total research expenses $827.9 3% $804.5 14% $705.6 Our research expenses reflect investment in our pipeline and expansion of our cell and genetic therapy capabilities, which has increased our outsourced services and other direct expenses and infrastructure costs in 2025 as compared to 2024.”

Annual report 2025A · The company itself

“CRISPR-Cas9 Gene-editing Therapies Agreements In 2015, we entered into a strategic collaboration, option and license agreement (the “CRISPR Agreement”) with CRISPR and its affiliates to collaborate on the discovery and development of potential new treatments aimed at the underlying genetic causes of human diseases using CRISPR-Cas9 gene-editing technology.”

Annual report 2025A · The company itself

“The manufacturing process for CASGEVY involves a number of steps prior to the final infusion of drug product into patients. Following mobilization and collection of blood cells from the patient, cells are transferred to a manufacturing site where HSPCs are purified and CRISPR/Cas9 gene-editing is performed. The edited cellular product, called CASGEVY, is frozen and transported back to the authorized treatment center where it is stored prior to infusion into the patient. Each step must be completed successfully, and in a timely manner, requiring coordination between us, authorized treatment centers, third-party manufacturers and shipping vendors.”

Annual report 2025A · The company itself

“We may not be able to increase or maintain CASGEVY product revenues. The future commercial success of CASGEVY depends on physicians, patients, or payors accepting it as medically useful, cost-effective, ethical, safe, and preferred with respect to current and potential future competitive therapies, and on payors providing adequate reimbursement.”

Annual report 2025A · The company itself

“In 2019, we elected to exclusively license three targets, including CF, pursuant to the CRISPR Agreement.”

Annual report 2025A · The company itself

“During the second half of 2023, Waters introduced the DynaProTM ZetaStarTM instrument through its Wyatt TechnologyTM portfolio for nanoparticle analysis. The new instrument simultaneously enables dynamic and static light scattering and dynamic and electrophoretic light scattering measurements, all in one device. By combining multiple light scattering techniques and automatically assessing data quality and performing adaptive data capture, the ZetaStar instrument delivers both increased sensitivity and faster measurements to aid the precise development of complex biologics, using extremely low sample volumes.”

Annual report 2025A · The company itself

“In 2024, the Company introduced HPLC CONNECT software, an all-in-one software platform that enables full digital synchronization between Waters high- and ultra-performance liquid chromatography (HPLC/UPLC) systems and multi-angle light-scattering instruments (MALS) from its Wyatt Technology portfolio. The software delivers ease-of-use, greater efficiency, and higher confidence for scientists performing size exclusion chromatography and MALS (SEC-MALS) analyses for complex and critical biopharmaceutical innovations, including antibody drug conjugates, other complex protein conjugates, and gene therapies.”

Annual report 2025A · The company itself

“Also, in 2025 Waters acquired Halo Labs an innovator of specialized imaging technologies to detect, identify, and count interfering materials (particles) in therapeutic products, such as cell, protein and gene therapies. The addition of the Halo Labs product portfolio compliments and expands our particle analysis capabilities beyond what can be achieved with Wyatt’s multi-angle light scattering technology alone.”

Annual report 2025A · The company itself

“In 2023, the Company introduced the first in a new line of size exclusion chromatography columns aimed at improving analysis while lowering the cost of gene therapies, specifically adeno-associated viral (“AAV”) vectors. The new Waters XBridgeTM Premier GTx BEHTM size exclusion chromatography columns double the speed of measuring the potency and safety of AAVs. Combining the columns with light scattering technologies from its Wyatt Technology portfolio deepens the level of information acquired from a single experiment and optimizes the manufacturing of these novel gene delivery vehicles.”

Annual report 2025A · The company itself

“In 2025, the Company introduced the Waters Xevo Charge Detection Mass Spectrometer (“CDMS”), delivering unmatched measurement and characterization for the broadest range of mega-mass biomolecules central to next-generation therapeutics and structural biology. The Waters Xevo CDMS provides confident analysis of new modalities, like empty, partial and full viral vector capsids, using up to 100-fold less sample volume than that required by current techniques, and delivering results in less than ten minutes, even at concentrations as low as 1010 vp/mL. This new capability paves the way for real-time characterization of gene therapies during process development — ultimately improving the safety and efficacy of advanced therapies.”

Annual report 2025A · The company itself

“Strategic Shift Post-Business Combination Following the business combination with Zelluna Immunotherapy AS, the Company is prioritizing the de-velopment of Zelluna Immunotherapy AS’s proprietary TCR-NK cell therapy platform. The strategic focus is now on i.) advancing the world's first MAGE-A4 targeting TCR-NK program, ZI-MA4-1, into first-in-hu-man clinical studies treating solid cancers, ii.) developing the TCR-NK pipeline, and iii.) seeking to unlock the MultiClick technology potential.”

Annual report 2024A · The company itself

“Zelluna is a biotech company whose mission is to eliminate solid cancers by unleashing the most powerful elements of the immune system through pioneering the development of T cell receptor (TCR) guided natural killer (NK) cell therapies (TCR-NK).”

Annual report 2024A · The company itself

“Zelluna is developing a novel allogeneic cell therapy platform combining Natural Killer ("NK") cells with tumour specific T cell receptors ("TCRs") ("TCR-NK"). The TCR-NK products are composed of healthy donor derived NK cells that are genetically engineered to express a tumour specific TCR that enable the TCR-NK cells to identify and eliminate cancer cells in the body of the patient.”

Annual report 2024A · The company itself

“The lead asset nearing the clinic is a world’s first MAGE-A4 targeting TCR-NK which can potentially be used to treat a range of solid cancers with unmet medical need in high value cancer markets.”

Annual report 2024A · The company itself

“The combined company will mainly focus on Zelluna Immunotherapy AS’s technology and research pipeline, specifically the development of “off-the-shelf” T-Cell Receptor Natural Killer (TCR-NK) cell therapies for the treatment of a range of solid cancers and wrap up the UV1 program.”

Annual report 2024A · The company itself

“Specifically, cell therapies are a class of therapeutics that have delivered “cures” in late-stage cancer patients with 9 therapies currently market approved mainly for liquid cancers and several with data from fewer than 100 patients for regulatory approval.”

Annual report 2024A · The company itself