The pending merger with Novo Holdings could cause substantial disruptions in the company's business and create uncertainty, which may materially affect the business, financial condition, or results of operations.

Catalent has invested over $3.6 billion in its biologics business since fiscal 2020, including capital investments and acquisitions of biologics-focused businesses and sites, indicating a strategic focus on this growing market.

Catalent has executed 22 transactions since fiscal 2013, investing approximately $4.9 billion, and intends to identify and execute strategic transactions to optimize its portfolio of offerings and businesses.

The company experienced productivity issues at three facilities, including two of its largest, relating to deployment of a new ERP system and the need to implement operational and engineering controls following regulatory inspections.

Catalent is implementing a restructuring effort, which reduced its cost structure, consolidated facilities, and optimized its infrastructure across the organization. The company reduced its headcount by approximately 700 employees and incurred $39 million of cumulative pre-tax employee separation and other restructuring related costs.

Management identified a material weakness in internal control related to inventory costing and valuation at its Bloomington, Indiana facility, indicating a need for improved processes and expertise.

The pending merger with Novo Holdings introduces risks such as potential failure to complete the merger, restrictions on business activities, and potential litigation, which could adversely affect the company's business and financial condition.

The company anticipates being subject to increasing focus by investors, regulators, customers, and other stakeholders on environmental, social, and governance (ESG) matters, which could pose reputational challenges if ESG scores or practices do not meet desired standards.

As part of the highly regulated healthcare industry, Catalent is subject to stringent regulatory standards and other applicable laws and regulations, which can change unexpectedly or be the subject of unexpected changes in interpretation or enforcement, any of which may adversely impact our business.

Catalent operates in a highly competitive market, competing with multiple companies offering conventional and advanced technologies for development, supply, and delivery of medicinal products and services.

The healthcare industry is characterized by rapid technological change, and the demand for Catalent's offerings may change in ways it may not anticipate because of evolving industry standards and customer needs.

Catalent's broad and diverse range of technologies closely integrates with customers' molecules to yield safe and effective final formulations and dose forms, and this generally results in the inclusion of Catalent in customers' prescription product regulatory filings. Both factors translate to long-duration supply relationships at an individual product level.

Catalent's manufacturing operations are focused on employee health and safety, regulatory compliance, operational excellence, continuous improvement, and process standardization across the organization, achieving approximately 96% on-time shipment delivery versus customer request date.

Supplier relationships could be interrupted due to natural disasters and international supply disruptions, including those caused by pandemics or geopolitical and other issues, which could hinder the ability to timely supply customers with products.

Catalent promotes operational discipline and drives margin expansion through its existing infrastructure, including its global network of operating locations and programs, with an active focus on continuous improvement and sustainability enhancement.

Catalent has broad and diverse technology platforms that are supported by deep scientific and technical expertise, extensive know-how, and more than 2,100 patents and patent applications.

Catalent's breadth of offerings employs advanced technologies and state-of-the-art manufacturing systems, with a long track record of innovation substantially differentiating it from other industry participants.

If Catalent cannot keep pace with rapid technological advances, its services may become uncompetitive or obsolete, and its revenue and profitability may decline.

The company has invested $1.56 billion in its manufacturing and development facilities since fiscal 2022 for improvements and expansions, including $327 million in capital expenditures during fiscal 2024.

Catalent operates in the markets for outsourced development solutions and commercial supply, and has executed 22 transactions since fiscal 2013, investing approximately $4.9 billion.

The company currently intends to retain future earnings for future operations, expansion, and debt repayment, and has no current plan to pay any cash dividend on its Common Stock for the foreseeable future.

Catalent'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, meets its commitments to all its stakeholders, and contributes to the long-term success of the industries it serves and the communities where it operates.

In fiscal 2024, Catalent made significant progress in several ESG focus areas, including purchasing renewable electricity for its operating sites, reducing water usage in water-stressed areas, and increasing the volume of waste diverted from landfill.

Catalent continues to reduce its carbon emissions and has an approved set of Science Based Targets (SBT). These targets commit Catalent to reducing absolute scope 1 and 2 GHG emissions 42% by fiscal 2030 from a fiscal 2022 base year.

Catalent serves approximately 1,200 customers in more than 80 countries, with 36% of its fiscal 2024 net revenue coming from outside the U.S.

Catalent's global operations are subject to economic and political risks, including risks resulting from continuing inflation, disruptions to global supply chains, and the Ukrainian-Russian war.

Catalent participates in nearly every sector of the global pharmaceutical and biotechnology industry, which has been estimated to generate more than $1 trillion in annual revenue.