Healthcare
Drug Manufacturers - Specialty & Generic
$11.52B
18K
Catalent, Inc., together with its subsidiaries, develops and manufactures solutions for drugs, protein-based biologics, cell and gene therapies, and consumer health products worldwide. It operates in two segments, Biologics, and Pharma and Consumer Health. The 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 Pharma and Consumer Health segment offers formulation, development, and manufacturing services for soft capsules for use in a range of customer products, such as prescription drugs, over-the-counter medications, dietary supplements, unit-dose cosmetics, and animal health medicinal preparations; and oral, nasal, inhaled, and topical dose forms. This 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; and pre-clinical screening, formulation, analytical development, and current good manufacturing practices manufacturing at clinical and commercial scale for softgel capsule, Zydis fast-dissolve tablets, oral solid-dose formats, dry powder inhalers, and nasal delivery devices. The company also offers FlexDirect direct-to-patient and FastChain demand-led clinical supply solutions; fill and finish operations for injectable products; and integrated development and product supply chain solutions. It serves biotechnology, pharmaceutical, and consumer health companies; and companies in other healthcare market segments, such as animal health and medical devices, as well as in cosmetics industries. The company was founded in 1933 and is headquartered in Somerset, New Jersey.
Key insights and themes extracted from this filing
Net revenue decreased by $431 million, or 9%, compared to the fiscal year ended June 30, 2022, excluding the impact of foreign exchange. The decrease was primarily driven by a significant decline in demand for COVID-19 related programs.
Gross margin decreased by $544 million, or 34%, in fiscal 2023 compared to fiscal 2022, excluding the impact of foreign exchange, primarily due to an unfavorable shift in product mix, lower levels of utilization across the network, inventory write-offs, operational challenges that meaningfully reduced productivity, and higher costs from increased spending on operational and engineering enhancements.
The company reported a net loss of $256 million for fiscal year 2023 compared to net earnings of $499 million in fiscal year 2022. This is primarily attributed to decreased operating earnings and goodwill impairment charges.
Since 2019, the company has invested over $3.42 billion in its biologics business, including capital investments and approximately $1.83 billion for acquisitions of biologics-focused businesses and sites.
Since fiscal 2013, the company has executed 22 transactions, investing approximately $4.91 billion, and have demonstrated an ability to efficiently and effectively integrate these acquisitions.
As of June 30, 2023, product development teams were working on more than 1,500 customer development programs in active development across the business. In fiscal 2023, the company introduced 216 new products for its customers.
Through the company's existing infrastructure, including its global network of operating locations and programs, it promotes operational discipline and drives margin expansion. With an active focus on continuous improvement and sustainability enhancement, global procurement function, and conversion cost productivity metrics in place, the company continuously seeks to enhance its culture of functional excellence and cost accountability.
In the fourth quarter of fiscal 2023, the company announced that it experienced productivity issues at three of its facilities, including two of its largest manufacturing facilities in fiscal 2023, relating to, among other things, deployment of a new enterprise resource planning (ERP) system and continued need to implement enhancements to operational and engineering controls following regulatory inspections, which led to reductions in revenues and increases in costs at these sites in fiscal 2023.
Management is actively engaged in the implementation of remediation efforts to address the remaining material weaknesses and control deficiencies. However, there can be no assurance that the company will be successful in promptly remediating these material weaknesses or be able to identify and remediate any additional control deficiency, including any material weakness, that may arise in the future.
The company has been, and may in the future be, subject to activities initiated by activist shareholders. Any resulting activist campaign that contests, or seeks to change, the company's strategic direction or business mix could have an adverse effect on the company.
The company anticipates being subject to increasing focus by its investors, regulators, customers, and other stakeholders on environmental, social, and governance (“ESG”) matters. If the company's ESG scores or practices do not meet desired standards, it may face reputational challenges.
Any failure to implement fully, monitor, and continuously improve the company's quality management strategy could lead to quality or safety issues and expose the company to significant costs, potential liability, and adverse publicity.
Competition is driven by proprietary technologies and know-how (where relevant), capabilities, consistency of operational performance, availability of equipment, quality, regulatory track record, price, value, responsiveness, and speed.
Some of the company's competitors are substantially larger than it is and have access to more substantial resources, which could be deployed to expand their range of offerings or capacity.
The company's broad and diverse range of technologies closely integrates with its customers' molecules to yield safe and effective final formulations and dose forms, and this generally results in the inclusion of Catalent in its customers' prescription product regulatory filings. Both factors translate to long-duration supply relationships at an individual product level.
The company's manufacturing operations are focused on employee health and safety, regulatory compliance, operational excellence, continuous improvement, and process standardization across the organization. In fiscal 2023, the company achieved approximately 95% on-time shipment delivery versus customer request date across its network as a result of this focus.
In the second quarter of fiscal 2023, the company engaged in a restructuring effort, which reduced its cost structure, consolidated facilities, and optimized its infrastructure across the organization. In the fourth quarter of fiscal 2023, the company extended its restructuring effort, with further headcount reduction primarily in its Biologics segment and in its corporate functions.
Globally, the company's supplier relationships could be interrupted due to natural disasters and international supply disruptions, including those caused by pandemics or geopolitical and other issues. If there were a future disruption in the supply of gelatin or any other key material from any one or more of the company's current principal suppliers, there can be no assurance that it could obtain an adequate alternative supply from its other suppliers.
The company's breadth of offerings employing advanced technologies and state-of-the-art manufacturing systems and long track record of innovation substantially differentiate it from other industry participants.
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.
Artificial intelligence, or AI, based platforms are increasingly being used in the biopharmaceutical, pharmaceutical, and consumer health industries. The company is committed to providing a safe and secure environment for its personnel, its business partners, and its customers, including the responsible use of AI chatbots and generative AI data processor products
The company has made over time, and expects to continue to make, significant investments in its manufacturing network, which is capable of serving customers and patients worldwide, and today employ approximately 8 million square feet of manufacturing, laboratory, and related space across four continents.
We have invested $1.93 billion in our manufacturing and development facilities since fiscal 2021 for improvements and expansions, including $583 million in capital expenditures during fiscal 2023.
Research and development costs amounted to $18 million, $23 million, and $21 million for fiscal 2023, 2022, and 2021, respectively.
The company's CR strategy, which includes its ESG strategy, is integrated into its company-wide strategic plan, ensuring that it operates in alignment with its values, meet its commitments to all its stakeholders, and contribute to the long-term success of the broader biopharmaceutical, pharmaceutical, and consumer health industries and the communities where it operates.
In February 2023, the company published its fourth annual Corporate Responsibility report (covering fiscal 2022), which includes an evaluation of its performance against the standards set by the Sustainability Accounting Standards Board (SASB) for Biotechnology and Pharmaceuticals and the recommendations of the Task Force on Climate-Related Financial Disclosures (TCFD).
The company purchased renewable electricity for its operating sites, with energy attribution certificates (EACs) accounting for 81% of its electricity use by the end of fiscal 2022, compared to 23% at the end of fiscal 2021, thus reducing its total Scope 1 and 2 emissions by 38%, from a fiscal 2020 baseline.
Our global operations are subject to economic and political risks, including risks resulting from continuing inflation, disruptions to global supply chains, destabilization of a regional or national banking system, or from the Ukrainian-Russian war or the effect of the evolving nature of the recent war in Gaza between Israel and Hamas, which could affect the profitability of our operations or require costly changes to our procedures
The company operates in a market that is highly competitive. Competition is driven by proprietary technologies and know-how, capabilities, consistency of operational performance, quality, price, value, responsiveness, and speed.
The healthcare industry is characterized by rapid technological change. Demand for our offerings may change in ways we may not anticipate because of evolving industry standards as well as a result of evolving customer needs that are increasingly sophisticated and varied and the introduction by others of new offerings and technologies that provide alternatives to our offerings.