User Base and Market Presence - The company has an active user base of approximately 100,000 practices and 321,000 consumers utilizing various software solutions as of December 28, 2024[41]. - The company aims to increase penetration of its existing customer base, which currently exceeds one million customers worldwide[50]. - The company develops and distributes a broad portfolio of dental implants and digital solutions, serving customers in approximately 90 countries[39]. Financial Performance and Sales - In 2024, dental merchandise accounted for 37.3% of consolidated net sales, while total dental products represented 52.7% of sales[45]. - The medical segment saw a slight increase in sales to 32.2% in 2024, compared to 31.7% in 2023[45]. - Seasonal fluctuations in sales are expected to continue, with higher sales typically occurring in the third and fourth quarters due to seasonal product demand[55]. - The company has experienced increased costs and shortages of purchased components, negatively impacting profit margins and sales[146]. - The company is exposed to risks associated with product liability and potential recalls related to corporate brand products, which could impact supplier relationships[157]. Strategic Initiatives and Growth Plans - The company is committed to enhancing its product offerings through organic investment and acquisitions to better serve customer needs[33]. - The company plans to pursue strategic acquisitions to expand its geographic footprint and access new products and technologies[50]. - The company aims to grow its specialty brands and technology solutions both organically and inorganically under the BOLD+1 Strategic Plan[147]. - The company has a strategic focus on expanding its Global Technology and Global Specialty Products segments[150]. Regulatory Compliance and Legal Risks - The DSCSA requires wholesalers and 3PLs to submit annual reports to the FDA, including information on each state where they are licensed[68]. - The UDI regulations mandate that labelers include unique device identifiers on medical device labels and packages, with compliance phased in starting from high-risk devices[69]. - The EU MDR significantly modifies regulatory compliance requirements for medical devices, including stricter clinical evaluation and quality system requirements[78]. - Compliance with legal requirements may necessitate delays in product release or voluntary recalls, potentially leading to financial losses and reputational harm[82]. - The company is subject to heightened enforcement activity regarding the storage, sale, and distribution of controlled substances under the Controlled Substances Act[71]. Employee Relations and Workforce Development - The company employs approximately 25,000 people, with 49% based in the United States and 51% outside the United States[121]. - Approximately 13% of the company's employees are subject to collective bargaining agreements, and the company believes its relations with employees are excellent[121]. - The company has rolled out a continuous listening program to gather feedback from employees, indicating a commitment to improving employee experience[123]. - The company has seen an increase in participation in professional development training programs, with employees reporting high utilization of skills learned[127]. - The company launched its seventh Employee Resource Group (ERG) in 2024, focusing on inclusivity and support for employees with disabilities[125]. Market Competition and Industry Trends - The health care products distribution industry is highly competitive, with significant competition from major manufacturers and distributors, which could adversely affect the company's margins and product availability[167]. - The company competes primarily on price, product breadth, e-commerce capabilities, and customer service in the North American market[27]. - The dental industry is expected to see increased expenditures as the population segment aged 45 and older grows, alongside rising demand for new technologies[51]. Cybersecurity and Operational Risks - The company experienced a cybersecurity incident in October 2023 that disrupted key business operations and adversely impacted financial results for Q4 2023 and the full year 2023[166]. - The incident led to significant remediation costs and has residual impacts on financial results in 2024[166]. - The company relies on information systems for critical operations, and any disruption or cybersecurity breach could lead to significant financial and operational impacts[164]. Economic and Market Conditions - Uncertain global and domestic macro-economic conditions may adversely affect the company's financial condition and operating results[172]. - The company has experienced inflationary pressures, including higher freight costs and interest expenses, impacting operational results[172]. - The health care industry is undergoing significant changes due to political, economic, and regulatory influences, which could materially affect the company's profitability[169]. Compliance with Privacy and Data Protection Laws - The company is subject to numerous evolving privacy laws, including GDPR, CCPA, and China's PIPL, which could impose significant compliance costs and penalties[195][196][197]. - Noncompliance with GDPR can result in penalties of up to EUR 20 million or 4% of global revenues, while China's PIPL carries maximum penalties of CNY 50 million or 5% of annual revenue[196][197]. - The CCPA, effective January 1, 2020, establishes new data privacy rights and statutory damages for violations, with the CPRA enhancing these requirements from January 1, 2023[199]. Financial Management and Risk Mitigation - The company maintains a strong balance sheet and diversifies investments to manage credit risks[380]. - The company engages in hedging programs using primarily foreign currency forward contracts to limit the impact of foreign currency exchange rate fluctuations on earnings[381]. - Disruptions in financial markets may adversely affect the availability and cost of credit, impacting the company's ability to make scheduled payments or refinance obligations[214].
Henry Schein(HSIC) - 2024 Q4 - Annual Report