Omnipod 5 was launched in the United Kingdom and Germany in June and August 2023, respectively, contributing to international revenue growth. Further expansion into more European markets is planned for 2024.

Enrollment was completed for the pivotal trial for Omnipod 5 with the goal of expanding its indication to individuals with type 2 diabetes. A 510(k) application to the FDA is expected by the end of 2024.

Construction of a new manufacturing plant in Malaysia was completed in December 2023, with production expected to begin in 2024. This plant will support international expansion and further ensure product supply.

The company reports a material weakness in IT general controls over systems supporting financial reporting outside of North America. Management is implementing additional processes and controls to address this weakness.

A new organizational operating model was introduced in the second half of 2023, which may initially be disruptive or confusing to some employees as job and reporting structures evolve.

The company continues to experience challenges stemming from the global supply chain disruption and is working to mitigate this disruption and ensure uninterrupted supply to customers.

The company continues to rely on sales of its Omnipod product platform to generate nearly all of its revenue, making it vulnerable to factors impacting Omnipod sales, including competition, manufacturing problems, and reimbursement changes.

Sales of Omnipod products will be limited unless a substantial portion of their sales price is paid for by third-party payors. Healthcare market initiatives in the United States may also lead third-party payors to decline or reduce reimbursement for Omnipod products.

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

The diabetes medical device market is highly competitive, subject to rapid change and significantly affected by new product introductions. Our Omnipod platform competes for consumers in the insulin delivery market.

The diabetes treatment market is subject to rapid technological change and product innovation. Our Omnipod products are based on our proprietary technology, but a number of companies, medical researchers, and pharmaceutical companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs, and other therapeutics for the monitoring, treatment, and/or prevention of insulin-dependent diabetes.

The competitive landscape in our industry continues to undergo significant change. We compete with companies that produce insulin pumps, such as Medtronic, Tandem, The Ypsomed Group and Roche Diabetes Care, Inc ("Roche").

Manufacturing problems or capacity constraints; actual or perceived quality problems; adverse regulatory or legal actions relating to our Omnipod products

The manufacture of our products requires the timely delivery of sufficient amounts of quality components and materials from many suppliers in various countries.

While we expect to begin production at our newly constructed manufacturing facility in Malaysia in 2024, currently our products are manufactured in two locations, at our U.S. manufacturing facility in Massachusetts and on manufacturing lines owned by us 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. If we are unable to introduce and market new products and keep pace with advances in technology, our business will be negatively impacted.

The healthcare industry is characterized by continuous technological change, resulting in changing consumer preferences and requirements. If we are unable to introduce and market new products and keep pace with advances in technology, our business will be negatively impacted.

Our success depends in part on our ability to develop or acquire commercially valuable intellectual property rights and to protect those rights adequately. We rely on a combination of patents, trade secrets, copyright and trademark laws, confidentiality, non-disclosure and assignment of invention agreements, and other contractual provisions and technical measures to protect our intellectual property rights.

We expect capital expenditures for 2024 to increase compared with 2023 given the timing of spending on machinery, equipment and tooling for our new Malaysia manufacturing facility and to support continuous improvement efforts in our other manufacturing locations.

We may in the future seek additional funds from public and private stock or debt offerings, borrowings under credit lines, or other sources, and we may need to raise additional debt or equity financing to repay our outstanding Senior Convertible Notes or other debt obligations.

Section 382 and 383 of the U.S. Internal Revenue Code imposes an annual limit on the amount of net operating loss and tax credit carryforwards that may be used to reduce taxes payable when a corporation has undergone significant changes in its stock ownership or equity structure.

By minimizing risks at our factories and implementing training to enhance awareness of hazards, we are able to promote safe practices and preserve the health of our employees.

We are committed to creating a diverse and inclusive global culture that reflects the diversity of the customers we serve and creates an environment where all employees feel welcomed, respected, and valued.

These ERGs support the acquisition of diverse talent and are sponsored by senior leaders across our organization.

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.

During the past several years, the U.S. healthcare industry has been subject to an increase in governmental regulation at both the federal and state levels.

The diabetes treatment market is subject to rapid technological change and product innovation. Our Omnipod products are based on our proprietary technology, but a number of companies, medical researchers, and pharmaceutical companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs, and other therapeutics for the monitoring, treatment, and/or prevention of insulin-dependent diabetes.