Catalent, Inc. 10-K (2022-08-29)

For the fiscal year ended June 30, 2022

 

 

 

ITEM 1.    BUSINESS

 

Overview

 

We provide 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.

 

differentiate : to recognize or show that two things are not the same / to be the particular thing that shows that things or people are not the same

 

rigorous : done carefully and with a lot of attention to detail / demanding that particular rules, processes, etc. are strictly followed

 

 

 

Our oral, injectable, and respiratory delivery technologies, along with our 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 and consumer health industries.

 

injectable : put into the body using a needle and syringe (= small tube)

 

respiratory : connected with breathing

 

modality : the particular way in which something exists, is experienced or is done / the idea expressed by modals / the kind of senses that the body uses to experience things

 

therapeutic : helping to treat an illness / helping you to relax

 

biopharmaceuticals : medicine and drugs that are produced using biotechnology (= the use of living things, especially cells and bacteria, in industrial processes)

 

 

 

Through our extensive capabilities, growth-enabling capacity, and deep expertise in product development, regulatory compliance, and clinical trial and commercial supply, we can help our 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.

 

 

 

Our development and manufacturing platforms, our proven formulation, supply, and regulatory expertise, and our broad and deep development and manufacturing know-how enable our customers to advance and then bring to market more products and better treatments for patients and consumers.

 

formulation : the act of creating or preparing something carefully, giving particular attention to the details; something that is created or prepared in this way / the act of expressing your ideas in carefully chosen words

 

 

 

Our commitment to reliably supply our customers’ and their patients’ needs is the foundation for the value we provide; annually, we produce nearly 80 billion doses for nearly 8,000 customer products, or approximately 1 in every 23 doses of such products taken each year by patients and consumers around the world.

 

 

 

We believe that, through our investments in state-of-the-art facilities and capacity expansion, including investments in facilities focused on new treatment modalities and other attractive market segments, our continuous improvement activities devoted to operational and quality excellence, the sales of existing and introduction of new customer products, and, in some cases, our innovation activities and patents, we will continue to attract premium opportunities and realize the growth potential from these areas.

 

 

 

We continue to invest in both our product and service offerings and our sales and marketing activities, leading to growth in the number of active commercial manufacturing and development programs for our customers.

 

 

 

This has further enhanced our extensive, long-duration relationships and long-term contracts with a broad and diverse range of industry-leading customers. In fiscal 2022, we conducted business with 87 of the top 100 branded drug marketers, 21 of the top 25 generics marketers, 24 of the top 25 biologics marketers, and 21 of the top 25 consumer health marketers globally.

 

 

 

Selected key customers include AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Moderna, Pfizer, and Sarepta Therapeutics.

 

 

 

We have many long-standing relationships with our customers, particularly those with commercial products, as we provide support and reliable supply through each stage of a product's lifecycle. Our relationship with an innovator of a prescription pharmaceutical product will often last many years—in several cases, two decades or more—extending from pre-clinical development through more mature stages of the product's life cycle.

 

 

 

We serve 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.

 

 

 

Our broad and diverse range of technologies closely integrates with all aspects of our customers’ final formulations and dose forms, and this generally results in the inclusion of our facilities as manufacturing and testing sites in our customers’ prescription product regulatory filings. Both factors frequently translate to long-duration supply relationships at an individual product level.

 

integrate : to combine two or more things so that they work together; to combine with something else in this way / to become or make somebody become accepted as a member of a social group, especially when they come from a different culture

 

inclusion : the act of including someone or something as part of a group, list, etc., or a person or thing that is included

 

 

 

We believe our customers value us because our depth of development solutions and state-of-the-art manufacturing technologies, continuous innovations and improvements, consistent and reliable supply, geographic reach, and substantial expertise enable us to create a broad range of business and product solutions that can be customized to fit their individual needs.

 

 

 

Today we employ more than 9,000 highly trained direct manufacturing associates, as well as more than 3,000 formulation, analytical development, and process scientists and technicians.

 

 

 

Our customers can also benefit from more than 1,400 patents and patent applications in advanced delivery platforms, drug and biologics formulation, and manufacturing. The aim of our offerings is to reliably supply their commercial needs and also allow our customers to bring more products to market faster and develop and market differentiated products that improve patient outcomes.

 

 

 

We believe our leading market position and diversity of customers, offerings, regulatory categories, products, and geographies reduce our exposure to potential strategic and product shifts within our industries.

 

 

 

We provide a wide variety of proprietary and non-proprietary, differentiated technologies, products, and service offerings to our customers across our development and manufacturing platforms, which we have advanced and grown over more than 90 years through internal development, strategic alliances, in-licensing, and acquisitions.

 

proprietary : (of goods) made and sold by a particular company and protected by a registered trademark / relating to an owner or to the fact of owning something

 

 

 

We initially introduced our softgel capsule technologies in the 1930s and have continuously expanded our range of offerings. In recent years, we have launched more than a dozen internally developed new technology platform offerings. We have also augmented our portfolio through acquisitions.

 

augment : to increase the amount, value, size, etc. of something

 

 

 

Among the technologies we currently offer are softgel capsules, including both gelatin and non-gelatin formulations, our Zydis orally disintegrating tablets, gummy and soft chew oral forms, protein production using advanced mammalian cell lines, adeno-associated virus (“AAV”) vectors, induced pluripotent stem cells (“iPSCs”), plasmid DNA (“pDNA”), and a range of other oral, injectable, and respiratory delivery technologies.

 

disintegrate : to break into small parts or pieces and be destroyed / to become much less strong or united and be gradually destroyed

 

mammalian : connected with mammals (= animals that give birth to live young and feed them with milk)

 

pluripotent : A pluripotent cell is able to develop into several different types of cell

 

 

 

The technologies and service offerings within our development solution platforms span the full drug development process, ranging from our OptiForm Solution Suite for enhancement of bioavailability and other characteristics of early-stage small molecules, Gene Product Expression (“GPEx”), GPEx Boost, GPEx Lightning for advanced cell line development, pDNA development and production and SMARTag platforms for development of biologics and antibody-drug conjugates (“ADCs”), to formulation, analytical services, early-stage clinical development, drug-device combination development and supply, fill and finish operations for injectable products, and clinical trials supply, including our unique FlexDirect direct-to-patient and FastChain demand-led clinical supply solutions.

 

span : to last all through a period of time or to cover the whole of it / to include a large area or a lot of things

 

molecule : a group of atoms that forms the smallest unit that a substance can be divided into without a change in its chemical nature 

 

conjugate : to give the different forms of a verb, as they vary according to number, person, tense, etc. / (of a verb) to have different forms, showing number, person, tense, etc. 

 

 

 

Our offerings serve a critical need in the development and manufacture of products across a broad range of product types. We focus on serving as an accelerator for new therapeutic modalities and formulation, delivery, and manufacturing technologies. Our expertise enables us to bring advanced products to market at scale, faster.

 

accelerator : the pedal in a car or other vehicle that you press with your foot to control the speed of the engine / a machine for making elementary particles move at high speeds 

 

 

 

(the rest omitted)