Catalent Profile
Catalent, Inc. provides differentiated development and manufacturing solutions for drugs, protein-based biologics, cell and gene therapies, vaccines, and consumer health products at over fifty facilities across four continents under rigorous quality and operational standards.
The company's oral, injectable, and respiratory delivery technologies, along with its state-of-the-art protein, plasmid, viral, and cell and gene therapy manufacturing capacity, address a wide and growing range of modalities and therapeutic and other categories across the biopharmaceutical, pharmaceutical, and consumer health industries. Through its extensive capabilities, growth-enabling capacity, and deep expertise in product development, regulatory compliance, and clinical trial and commercial supply, the company can help its customers take products to market faster, including more than half of new drug products approved by the U.S. Food and Drug Administration (the FDA) in the last decade. The company's development and manufacturing platforms, its proven formulation, supply, and regulatory expertise, and its broad and deep development and manufacturing know-how enable its customers to advance and then bring to market more products and better treatments for patients and consumers. The company's commitment to reliably supply its customers' and their patients' needs is the foundation for the value it provides; annually, it produces approximately 70 billion unit doses for nearly 8,000 customer prescription and consumer health products, or approximately 1 in every 26 unit doses of such products taken each year by patients and consumers around the world. Through its investments in state-of-the-art facilities and capacity expansion, including investments in facilities focused on new treatment modalities and other attractive market segments, its continuous improvement activities devoted to operational and quality excellence, the sales of existing and introduction of new customer products, and, in some cases, its innovation activities and patents, the company will continue to attract premium opportunities and realize the growth potential from these areas.
The company continues to focus on enhancing both its product and service offerings and its sales and marketing activities in order to grow the number of active commercial manufacturing and development programs for its customers. This sustains the company's extensive, long-duration relationships and long-term contracts with a broad and diverse range of industry-leading customers. In fiscal 2023, the company conducted business with 87 of the top 100 branded drug and consumer health marketers and 82 of the top 100 biologics marketers, measured on a global basis. Selected key customers include Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Haleon, Johnson & Johnson, Moderna, Pfizer, and Sarepta Therapeutics.
The company serves customers requiring some combination of innovative product development, superior quality, state-of-the-art manufacturing, and skilled technical services to support their development and marketed product needs. The company's broad and diverse range of technologies closely integrates with all aspects of its customers' final formulations and dose forms, and this generally results in the inclusion of its facilities as manufacturing and testing sites in its customers' prescription product regulatory filings.
The company provides a wide variety of proprietary and non-proprietary, differentiated technologies, products, and service offerings to its customers across its development and manufacturing platforms. The company initially introduced its softgel capsule technologies in the 1930s and has continuously expanded its range of offerings. The company offers are softgel capsules, including both gelatin and non-gelatin formulations, its Zydis orally disintegrating tablets, gummy and soft chew oral forms, protein production using advanced mammalian cell lines, adeno-associated virus (AAV) and other viral vectors, induced pluripotent stem cells (iPSCs) and other cell types, plasmid DNA (pDNA), and a range of other oral, injectable, and respiratory delivery technologies. The technologies and service offerings within the company's development solution platforms span the full drug development process, ranging from its OptiForm Solution Suite for enhancement of bioavailability and other characteristics of early-stage small molecules, Gene Product Expression (GPEx), GPEx Boost, and GPEx Lightning for advanced cell line development, pDNA development and manufacturing and SMARTag platforms for the development of biologics and antibody-drug conjugates (ADCs), to formulation, analytical, and bioanalytical services, early-stage clinical development, drug-device combination development and supply, fill and finish operations for injectable products, and clinical trials supply, including its unique FlexDirect direct-to-patient and FastChain demand-led clinical supply solutions. The company's offerings serve a critical need in the development and manufacture of products across a broad range of product types. The company focuses on serving as an accelerator for new therapeutic modalities and formulation, delivery, and manufacturing technologies.
Strategy
The key elements of the company's strategy are to build a differentiated biologics platform; use its proprietary technologies and substantial expertise to help its customers develop new products; build on its existing platform; intend to continue to use its development and manufacturing solutions across the entire lifecycle of its customers' products to drive future growth; and continue to grow through new projects and product launches.
Reportable Segments
The company operates through two segments, Biologics and Pharma and Consumer Health.
Biologics
Biologics segment provides formulation, development, and manufacturing for biologic proteins, cell gene, and other nucleic acid therapies; pDNA, iPSCs, oncolytic viruses, and vaccines; formulation, development, and manufacturing for parenteral dose forms, including vials, prefilled syringes, and cartridges; and analytical development and testing services for large molecules. The business has extensive expertise in development, scale up, and commercial manufacturing. Representative customers of the company's Biologics segment include Bristol-Myers Squibb, Johnson & Johnson, Moderna, and Sarepta Therapeutics, along with a broad range of innovative small and mid-tier biopharmaceutical customers.
The company's biologics offering includes cell-line development based on its advanced, patented GPEx suite of technologies, which are used to develop stable, high-yielding mammalian cell lines for both innovator and biosimilar biologic compounds. GPEx technology can provide rapid cell-line development, high biologics production yields, flexibility, and versatility. The company's development and manufacturing facility in Madison, Wisconsin has the capability and capacity to produce cGMP quality biologics drug substance from 250L to 4000L scale using single-use technology across five suites to provide maximum efficiency, redundancy, and flexibility. Additionally, the company's Madison, Wisconsin facility features two flexible cGMP suites that are used to manufacture mRNA or other small-scale biomolecules. The company's Bloomington, Indiana facility brings additional biologics development, clinical, and commercial drug substance manufacturing, and formulation development capabilities and capacity. Both Bloomington and its Anagni, Italy facility provide substantial capacity for finished-dose drug product manufacturing and packaging. The company's SMARTag next-generation ADC technology, based in Emeryville, California, is a clinical-stage technology that enables development of ADCs and other protein conjugates with improved efficacy, safety, and manufacturability.
At its pDNA, cell therapy, and gene therapy global centers of excellence in Belgium, Maryland, and New Jersey, the company develops and manufactures advanced therapeutics, including AAV, lentivirus, oncolytic virus, CAR-T, and other cell or virus modalities together with critical pDNA biological starting material for cell, mRNA, viral-based therapies and next-generation vaccines. In 2022, the company acquired a fully operational, commercial-scale cell therapy campus in Princeton with 16 suites available for both autologous and allogeneic clinical and commercial manufacturing. The Princeton campus works in conjunction with the company's Gosselies, Belgium cell therapy center of excellence and its iPSC manufacturing center of excellence in Dusseldorf, Germany, to support its customers' global cell therapy needs. Additionally, the company has expanded its gene therapy flagship manufacturing campus in Harmans, Maryland, creating a total of 18 penthouse-style viral-vector suites, and added its Virtuoso AAV platform that reduces AAV development time by half, enabling its customers to reach first-in-human studies faster. The company's specialized expertise in AAV vectors, the most commonly used delivery system for gene therapies, and iPSCs for next-generation allogeneic cell therapy manufacturing, together with its substantial global cell therapy manufacturing, capacity for clinical- through commercial-scale batches, and its capabilities in mRNA and pDNA manufacturing, position it to capitalize on strong industry demand and expansions in the use of newer modalities in the cell and gene therapy market.
The company's range of injectable manufacturing offerings includes manufacturing drug substances and filling small molecules or biologics into vials, syringes, and cartridges, with flexibility to accommodate other formats within its existing network. In addition to primary packaging, its network provides secondary packaging capabilities, including auto-injector and safety device assembly for commercial launch and life-cycle management. The company's clinical supply services business provides a global network for clinical distribution, as well as labeling, packaging, and cold-chain storage for clinical trials and commercial supply of biotherapeutics and cell and gene therapies. The company's fill and finish services are largely focused on complex pharmaceuticals and biologics. With its range of technologies, the company is able to meet a wide range of specifications, timelines, and budgets.
The company also offers analytical development and testing services for proteins, gene and cell therapies, and other biologic modalities, including bioassay, biophysical characterization, and cGMP release and stability testing. The company's OneBio Suite provides customers with the potential to seamlessly integrate drug substance, drug product, and clinical supply management for products in development, and for integrated commercial supply across both drug substance and drug product. The company provides a broad range of technologies and services supporting the development and launch of new biologic entities, biosimilars, biobetters, and cell and gene therapies to bring a product from gene to commercialization, faster.
Pharma and Consumer Health
Through its Pharma and Consumer Health segment, the company provides market-leading capabilities for complex oral solids, softgel formulations, Zydis fast-dissolve technologies, and gummy, soft chew, and lozenge dosage forms; formulation, development, and manufacturing platforms for oral, nasal, inhaled, and topical dose forms; and clinical trial development and supply services.
Representative customers of the company's Pharma and Consumer Health segment include Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Haleon, Pfizer, and Procter & Gamble. The company's Pharma and Consumer Health segment represented 54% of its aggregate net revenue before inter-segment eliminations for fiscal 2023.
Formulation and development
Through its comprehensive pharmaceutical formulation and development platform, the company provides pre-clinical screening, formulation, and analytical development, and cGMP manufacturing at both clinical and commercial scale for its market-leading softgel capsule and Zydis fast-dissolve tablet platforms, traditional and advanced complex oral solid-dose formats, dry powder inhalers, and nasal delivery devices. The company has substantial, proven experience in developing and scaling up orphan and rare disease products, especially those requiring accelerated development timelines, solubility enhancement, specialized handling (e.g., potent or controlled substance materials), complex technology transfer and specialized manufacturing processes. The company provides fluid bed coating, spray drying, hot melt extrusion, micronization, and lipid formulation capabilities, all of which are used to enhance a drug's administration and release profile and its clinical performance. The company offers comprehensive analytical method development and scientific capabilities, including stability testing and global regulatory services to support both fully integrated development programs or standalone fee-for-service work. The company has a network of early development sites focused on earlier phase compounds (i.e., pre-clinical and Phase I) to engage with more customer molecules earlier in their development, with the intent to also support these molecules downstream as they progress towards commercial approval and supply. Demand for the company's offerings is driven by the need for scientific expertise, the depth and breadth of integrated services offered, as well as the reliability of its supply performance across quality and operational parameters.
Manufacturing
The company's large-scale cGMP pharmaceutical manufacturing solutions typically include clinical trial supplies, registration batches, and commercial production across a broad range of formats.
Softgel Technology Platform
The company provides formulation, development, and manufacturing services for soft capsules, or softgels, as well as large-scale manufacturing of oral solid dose forms for pharmaceutical and consumer health markets, along with supporting ancillary services. The company's softgel manufacturing technology was first commercialized by its predecessor in the 1930s, and the company has continually enhanced the platform since then. The company is the market leader in overall softgel development and manufacturing and hold the leading market position in innovator drug softgels. The company's principal softgel technologies include traditional softgel capsules, in which the shell is made of animal-derived gelatin, and Vegicaps and OptiShell capsules, in which the shell is made from plant-derived materials. Softgel capsules are used in a broad range of customer products, including prescription drugs, over-the-counter medications, dietary supplements, unit-dose cosmetics, and animal health medicinal preparations. Softgel capsules encapsulate liquid, paste, or oil-based formulations of active compounds in solution or suspension within an outer shell. In the manufacturing process, the capsules are formed, filled, and sealed simultaneously. The company typically performs encapsulation for a product within one of its softgel facilities, with active ingredients provided by customers or sourced directly by it. The company also participates in the softgel vitamin, mineral, and supplement business in selected regions around the world. The company's plant-derived softgel shells, available as Vegicaps and OptiShell capsules, allow innovators and consumer health customers to extend the softgel dose form to a broader range of active ingredients and serve patient and consumer populations that were previously inaccessible due to religious, dietary, or cultural preferences. The company's Vegicaps and OptiShell capsules are protected by patents in most major global markets. Physician and patient studies the company has conducted have demonstrated a preference for softgels versus traditional tablet and hard capsule dose forms in terms of ease of swallowing, real or perceived speed of delivery, ability to remove or eliminate unpleasant odor or taste, and, for physicians, perceived improved patient adherence with dosing regimens.
In addition to softgel capsules, following its fiscal 2022 acquisition of Bettera Holdings, LLC (Bettera Wellness), the company also conducts formulation, development, and manufacturing of gummies, soft chews, and lozenges in a variety of sizes and shapes serving the dietary supplements market at three facilities in the United States. The company uses dietary and food ingredients provided by its customers or sourced directly by it, and the company also provides ancillary services such as analytical testing and packaging.
Clinical Supply Services
The company's Pharma and Consumer Health segment also provides clinical supply services through manufacturing, packaging, storage, distribution, and inventory management for small-molecule drugs, protein-based biologics, and cell and gene therapies in clinical trials. The company offers customers flexible solutions for clinical supplies production and provides distribution and inventory management support for both simple and complex clinical trials. This includes over-encapsulation where needed; supplying placebos, comparator drug procurement, and clinical packages and kits for physicians and patients; inventory management; investigator kit ordering and fulfillment; cold-chain storage and distribution; and return supply reconciliation and reporting. The company supports trials in all regions of the world through its facilities and distribution network. In recent years, the company has extended its network, with significant expansions at its Philadelphia, Pennsylvania and Shanghai, China free trade zone locations and facilities in California, China, and Japan. The company also continues to develop new solutions for the evolving clinical trial environment, including FlexDirect direct-to-patient, CT Success clinical supply planning, and extensive cold-chain investments. The company is the leading provider of integrated development solutions and one of the leading providers of clinical trial supplies.
The company has partnered with companies who focus on the development of cannabis-based prescription medicines and high-value cannabinoid drug therapies whose goal is to achieve full regulatory approval under the strictest legal standards in effect in any jurisdiction affected, including cannabidiol and tetrahydrocannabinol pharmaceutical products using its Zydis technology in clinical trials across a range of indications, including multiple sclerosis spasticity, chemotherapy-induced nausea and vomiting, chronic pain for cancer, and epilepsy. The company's total net revenue related to such development programs was less than 1% of total revenue generated in fiscal 2023.
Integrated Development and Product Supply Chain Solutions
In addition to its proprietary offerings, the company is differentiated in the market by its ability to bring together its development solutions and state-of-the-art product manufacturing to offer integrated development and product supply solutions that can be combined or tailored in many ways to enable its customers to take their drugs, biologics, and consumer health products from laboratory to market, faster. Once a product is on the market, the company can provide comprehensive, integrated product supply, from the sourcing or supply of the bulk active ingredient to comprehensive manufacturing and packaging, to the testing required for release, and to cold-chain or ambient temperature distribution. The customer- and product-specific solutions the company develops are flexible, scalable, and creative, so that they meet the unique needs of both large and emerging biopharmaceutical, pharmaceutical, and consumer health companies and are appropriate for products of all sizes. The company's development and product supply solutions, such as OptiForm Solution Suite and OneBio Suite, will continue to contribute to its future growth.
Sales and Marketing
The company's target customers include large pharmaceutical and biotechnology companies, mid-size, emerging, and specialty pharmaceutical and biotechnology companies, and consumer health companies, along with companies in other selected healthcare market segments such as animal health and medical devices, and companies in adjacent industries, such as cosmetics. The company has longstanding, extensive relationships with leading pharmaceutical, biotechnology, and consumer health customers. In fiscal 2023, the company did business with 87 of the top 100 branded drug and consumer health marketers and 82 of the top 100 biologics marketers, measured on a global basis, as well as with more than 1,200 other customers.
The company follows a hybrid demand-generation organization model, with strategic account teams offering the full breadth of its solutions, and technical specialist teams providing the in-depth technical knowledge and practical experience essential for each individual offering, both supported by a dedicated team of deeply experienced scientific advisors. The company's sales organization consists of more than 200 full-time, experienced sales professionals, supported by inside sales and sales operations. The company also have built a dedicated strategic marketing team, providing strategic market and product planning and management for its offerings. As part of its marketing efforts, the company participates in major trade shows relevant to its offerings globally and ensure adequate visibility to its offerings and solutions through a comprehensive advertising and publicity program.
Global Accounts
The company manages select accounts globally due to their substantial current business or growth potential. The company recorded approximately one-third of its total net revenue in fiscal 2023 from these global accounts.
Emerging, Specialty, and Virtual Accounts
The company expects to continue to increase its penetration of geographic clusters of emerging companies in North America, Europe, Central and South America, and Asia. The company regularly uses active pipeline and product screening and customer targeting to identify the optimal candidates for partnering based on product profiles, funding status, and relationships, to ensure that its technical sales specialists and field sales representatives develop custom solutions designed to address the specific needs of these customers.
Seasonality; Fluctuations in Operation Results
The company's annual financial reporting period ends on June 30. The company's revenue and net earnings are generally higher in the third and fourth quarters of each fiscal year, with its first fiscal quarter (year ended June 30, 2023) typically generating its lowest revenue of any quarter, and its last fiscal quarter typically generating its highest revenue. These fluctuations are primarily the result of the timing of the company's and its customers' annual operational maintenance periods at locations in the U.S. and Europe, the seasonality associated with pharmaceutical and biotechnology budgetary spending decisions, clinical trial and research and development schedules, the timing of new product launches and length of time needed to obtain full market penetration, and, to a lesser extent, the time of the year some of its customers' products are in higher demand, or are being produced to support future seasonal demand.
Contractual Arrangements
The company generally enters into a broad range of contractual arrangements with its customers, including agreements with respect to feasibility, development, supply, licenses, quality, and confidentiality. The terms of these contracts vary significantly depending on the offering and customer requirements. Some of its agreements may include a variety of revenue arrangements, such as fee-for-service, unit pricing in one or more tiers, minimum volume commitments, royalties, manufacturing preparation services, profit-sharing, and fixed fees. The company's typical supply agreements include indemnification from its customers for product liability and intellectual property matters and caps on its contractual liabilities, subject in each case to negotiated exclusions.
Research and Development Costs
The company's research and development costs amounted to $18 million for fiscal 2023/.
Intellectual Property
The company has applied in the U.S. and certain other countries for registration of a number of trademarks, service marks, and patents, some of which have been registered and issued, and also hold common law rights in various trademarks and service marks. The company has broad and diverse technology platforms that are supported by deep scientific and technical expertise, extensive know-how, and more than 1,800 patents and patent applications in approximately 170 families across advanced delivery platforms, drug and biologics formulation, and manufacturing.
The company holds patents and license rights relating to certain aspects of its formulations, pharmaceutical and nutritional dosage forms, mammalian cell engineering, antibody-drug conjugation, iPSCs, and plasmid DNA manufacturing. The company also holds patents relating to certain processes and products. The company has pending patent applications in the U.S. and certain other countries and intend to pursue additional patents as appropriate. The company has enforced and will continue to enforce its intellectual property rights in the U.S. and worldwide in appropriate circumstances.
The company has U.S. or foreign registrations for the following marks, among others: Bettera, Catalent, Clinicopia, CosmoPod, Easyburst, FastChain, FlexDirect, Follow the Molecule, Galacorin, GPEx, GPEx Boost, GPEx Lightning, Graphicaps, Liqui-Gels, Manufacturing Miracles, Micron Technologies, OmegaZero, OneBio, OneXpress Solution, OptiDose, OptiForm, OptiGel, OptiGel Bio, OptiGel DR, OptiMelt, OptiShell, PEEL-ID, Pharmatek, RP Scherer, Savorgel, Scherer, SMARTag, Softdrop, Staby, StabyExpress, SupplyFlex, Vegicaps, Zydis, and Zydis Ultra. The company usecscertain other trademarks and service marks, some on an unregistered basis and some have been applied for, but remain pending examination in trademark agencies in the U.S. and abroad, including, FlexDose, Catalent Xpress Pharmaceutics, OptiPact, ProteoSuite, StartScore, and Virtuoso.
Regulatory Matters
Certain of the company's subsidiaries are required to register for permits or licenses with, and must comply with the operating, cGMP, quality, and security standards of, applicable domestic and foreign healthcare regulators, including the FDA, the U.S. Drug Enforcement Agency (the DEA), the U.S. Department of Health and Human Services (the DHHS), the equivalent agencies of the E.U. and its member states, and various state boards of pharmacy, state health departments, and comparable agencies in other jurisdictions, as well as various accrediting bodies, each depending upon the type of operations and the locations of distribution and sale of the products manufactured or services provided by those subsidiaries.
In addition, various aspects of the company's business are subject to other healthcare laws, including the U.S. Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, the Controlled Substances Act, and comparable state and foreign laws and regulations relevant to their activities. he company is also subject to various other laws and regulations concerning the conduct of its non-U.S. operations, including the U.S. Foreign Corrupt Practices Act, the U.K. Anti-Bribery Act, and other anti-bribery laws and laws pertaining to the accuracy of its internal books and records. Furthermore, the company is subject, in various jurisdictions, including the E.U. and certain U.S. states, to various privacy laws protecting data the company may collect or process from employees, its customers' patients, or others.
The company's operations are subject to a variety of environmental, health, and safety laws and regulations, including those of the U.S. Environmental Protection Agency (the EPA.), the U.S. Occupational Safety & Health Administration (OSHA), and equivalent state, local, and national regulatory agencies in each of the jurisdictions in which the company operates.
History
Catalent, Inc. was founded in 1933. The company was incorporated in 2007.
