Omnipod 5 was launched in the Netherlands and France in June 2024, and is now available in Italy, Denmark, Finland, Norway, and Sweden as of January 2025. This strategic expansion aims to increase the company's global market presence.

In August 2024, the FDA cleared Omnipod 5 for use in people with type 2 diabetes, expanding the addressable market for the product. The company decided not to move forward with Omnipod GO.

Due to positive results from the Omnipod 5 type 2 pivotal trial, the company decided not to move forward with commercialization of Omnipod GO, focusing instead on Omnipod 5 for type 2 diabetes market.

The company began producing product at its new manufacturing plant in Malaysia in 2024, increasing capacity and supporting international expansion. This is expected to drive higher gross margins over time.

The company continues to invest in supply chain efficiencies, including automation improvements at suppliers and contract manufacturers. This focus aims to ensure product supply and maintain high quality.

The company ensures cybersecurity measures are prioritized across research and development, software engineering, and information technology functions. The CTO supports the CISO in chairing a Technology Risk Committee.

The company expects to continue to derive nearly all revenue from its Omnipod product platform, making it highly reliant on its ability to market and sell these products and retain consumers.

Sales of Omnipod products are expected to be limited unless a substantial portion of their sales price is paid for by third-party payors, including private insurance companies and government healthcare agencies.

Future and existing international operations may subject the company to a number of additional risks and expenses, including political instability, trade protection measures, and difficulties in managing international relationships.

The company competes with companies that produce insulin pumps, such as Medtronic and Tandem, as well as those that provide products and supplies for MDI therapy, which can be substantially less expensive than pump therapy.

The diabetes treatment market is subject to rapid technological change and product innovation, and breakthroughs in diabetes monitoring, treatment, or prevention could reduce the potential market for the company's products.

The competitive landscape in the industry continues to undergo significant change. Some competitors, such as Medtronic, are large, well-capitalized companies with more resources than the company.

The manufacture of the product is highly exacting and complex, due in part to strict regulatory requirements. The company and its contract manufacturer may encounter problems during manufacturing for a variety of reasons.

The manufacture of products requires the timely delivery of sufficient amounts of quality components and materials from many suppliers in various countries. The company works closely with suppliers, but cannot guarantee these efforts will always be successful.

The company's products are manufactured in three locations: at its manufacturing facility in the United States, at its newly constructed manufacturing facility in Malaysia, and on manufacturing lines owned by the company at a facility located in China that is operated by a third-party contract manufacturer.

The healthcare industry is characterized by continuous technological change, resulting in changing consumer preferences and requirements. The company must make substantial investments in new product development.

Omnipod 5 incorporates cybersecurity by design principles, which includes secure data transfer between the Pod, Controller, cloud storage, and compatible CGMs. The company's Secure Software Development Lifecycle enforces application testing and continuous monitoring to identify security risks.

The guiding principle of 'security and privacy by design' underlies all of the company's product development. The company has a cybersecurity team embedded with its research and development group to deliver on this mission.

Capital expenditures were $124.9 million in 2024, compared to $75.6 million in 2023. The increase primarily related to the purchase of machinery, equipment and tooling to increase manufacturing capacity for the new Malaysia manufacturing facility.

Investments in developed software were $9.1 million in 2024, and primarily related to investments in projects to support the company's cloud-based capabilities.

In 2024, the company made strategic investments in private companies in the amount of $12.2 million. In 2023, the company paid Bigfoot Biomedical, Inc. $25.1 million, including transaction costs, to acquire patent assets related to pump-based AID technologies.

The company's voluntary employee-led Employee Resource Groups ("ERGs”) are a thriving part of Insulet's community, driving inclusion across the following categories: African Descent, Asian and Pacific Islander, Hispanic/Latin, LGBTQ+, Sustainability, Veterans and First Responders, Women, Young Professionals, Jewish Heritage, and our newly created People with Diabetes.

The company maintains an occupational health and safety management system that covers all its employees, contractors, and temporary employees because it is committed to the safety and well-being of its workforce.

Increasingly, regulators, customers, investors, employees, and other stakeholders are focusing on environmental, social and governance matters and related disclosures. These changing rules, regulations, and stakeholder expectations have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent meeting such regulations and expectations and complying with disclosure requirements.

Efforts to control healthcare costs, including limiting access to care, alternative delivery models, and changes in the methods used to determine reimbursement systems and rates, are ongoing at the federal and state levels.

Continued concerns about the systemic impact of potential long-term and wide-spread recession and geopolitical issues, including wars and terrorism, have contributed to increased market volatility and diminished expectations for economic growth in the world.

The company is subject to a variety of laws and regulations relating to privacy and data protection. The introduction of new products or expansion of activities in certain jurisdictions may subject the company to additional laws and regulations.