Insulet (PODD) Risk Factor Changes

We are subject to income taxes, as well as taxes that are not income-based, in both the U.S.

and we may not realize the expected benefits of any acquisition or investment.

In addition, the sales and after-sale support of Omnipod products require a complex infrastructure of field sales personnel, diabetes educators, customer support, insurance specialists, and billing and collections per…

Our Credit Agreement imposes restrictions on us that may adversely affect our ability to operate or grow our business.

Our business, like that of most medical device manufacturers, involves the receipt, storage, and transmission of customer information, payment and reimbursement information, and confidential information about third-pa…

If our product is breached or our IT systems are breached or suffer severe damage, disruption, or shutdown and we are unable to effectively resolve the issues in a timely manner, our reputation, business, and operatin…

We rely on IT systems to process, transmit, and store electronic information, including personal, financial, and sensitive medical information.

We rely on the proper function, availability, and security of our products and IT systems; a successful cyber-attack or other breach or disruption of our products or these systems could have a material adverse effect…

We develop, license from other developers, and deploy AI tools, including generative AI tools for use in our operations.

We are subject to a variety of laws and regulations relating to privacy, data protection, and AI.

We are subject to complex and evolving laws and regulations regarding privacy, data protection, and artificial intelligence (“AI”), many of which are subject to change and uncertain interpretation, which could result…

Risks Related to Information Technology (“IT”), Privacy and Security

If we fail to comply with fraud and abuse and other healthcare regulations, including those relating to Medicare and Medicaid, we could be subject to substantial penalties and/or be excluded from participation in gove…

our promotional materials or training constitutes promotion of an off-label use, it could subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, se…

The FDA and similar governmental bodies in other countries have the authority to require the recall of our products if we or our contract manufacturer fails to comply with relevant regulations pertaining to manufactur…

Malfunction of our products could lead to recalls, safety alerts, or litigation and result in substantial costs and reputational damage.

We also sell our products in Canada, Australia, and certain countries in Europe and the Middle East.

•product clearances and approvals, including premarket clearance and approval;

Risks Related to Government Regulation and Product Liability

The manufacture of our product is highly exacting and complex, due in part to strict regulatory requirements.

•switching components or suppliers may require product redesign and submission to the FDA of a new 510(k);

Our reliance on third-party suppliers subjects us to other risks that could harm our business, including:

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

flood, could cause substantial delays in our operations, damage or destroy our manufacturing equipment and/or inventory, and cause us to incur additional expenses.

Our products are manufactured in three locations: at our manufacturing facility in the United States, at our manufacturing facility in Malaysia, and on manufacturing lines owned by us at a facility located in China th…

Our international operations, particularly our sales, manufacturing and supplier operations, may subject us to a number of risks and expenses, any of which could harm our operating results, including:

International expansion is a key component of our growth strategy.

A weakening of macroeconomic conditions may also adversely affect our suppliers, which could result in interruptions in supply.

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 expec…

The continuing worldwide macroeconomic and geopolitical uncertainty as well as the impact of another global pandemic may adversely affect our business and prospects.

Such litigation, regardless of its outcome, could result in the expenditure of significant financial resources and the diversion of management’s time and resources.

To help improve, market, and sell our Omnipod products, we have sponsored, and expect to continue to sponsor, clinical studies to assess various aspects of the functionality and relative efficacy of our products.

The diabetes treatment market is subject to rapid technological change and product innovation.

Additionally, diabetes associations, healthcare providers that focus on diabetes, or other organizations that may be viewed as authoritative could endorse products or methods that compete with our products or otherwis…

Our current competitors or other companies may at any time develop additional products for the treatment of diabetes.

In addition to the insulin pump competitors, we compete with companies that provide products and supplies for MDI therapy.

Our failure to compete effectively would negatively impact our revenue and results of operations.

Risks Related to Competition and Product Development

•uncertainties relating to the success of the pharmaceutical companies in marketing and selling their drugs as well as the modified Pods as the appropriate delivery devices;

•our ability to manufacture, and possible long lead-times associated with the development, regulatory approvals, and ramp up applicable to modified Pods;

•our identification of opportunities and development of appropriate modifications to our Omnipod technology to address the needs and parameters required for drug-delivery opportunities;

In addition to promoting, marketing, and selling Omnipod products through our own direct sales force, we utilize intermediaries to distribute our product.

If we fail to expand our relationships with intermediaries, our ability to grow our business may be materially and adversely affected.

As we expand our sales and marketing efforts internationally, we face additional risks associated with obtaining and maintaining reimbursement from foreign healthcare payment systems on a timely basis or at all.

We expect that sales of our Omnipod products would be limited if a substantial portion of their sales price is not paid for by third-party payors, including private insurance companies, health maintenance organization…

As we continue to expand the number of customers we serve, driven by increasing demand for Omnipod 5, our international expansion and entrance into the insulin-requiring type 2 diabetes market, we expect to continue t…

A key to driving our revenue growth is the retention of a high percentage of our customers.

We currently rely on sales of our Omnipod product platform to generate most of our revenue.

Market Risk.

In 2024, we worked to remediate a material weakness related to the effectiveness of information technology general controls over systems that support our financial reporting outside of North America, which has now bee…

A material weakness in our internal control over financial reporting could result in material misstatements in our financial statements and cause us to fail to meet our reporting and financial obligations.

condition, and results of operations could be materially and adversely affected.

The conversion of some or all our Convertible Senior Notes may dilute the ownership interests of existing stockholders.

Conversion of any of our Convertible Senior Notes may dilute the ownership interest of existing stockholders or depress our stock price.

We develop and license from other developers, and deploy, AI tools including Generative AI tools for use in our operations.

The rapidly-changing technical and regulatory environment and our AI-related activities may have an adverse effect on our business.

misuse of customer, third-party payor, employee, supplier, or Company data, could result in significant costs, lost sales, fines, lawsuits, and damage to our reputation.

The FDA and similar governmental bodies in other countries have the authority to require the recall of our products if we or our contract manufacturer fails to comply with relevant regulations pertaining to manufactur…

•maintaining appropriate gross margins; and

•uncertainties regarding the market acceptance of such drugs and the modified Pod as an appropriate delivery device;

•relatively small number of modified Pods needed to address each drug-delivery opportunity;

•manufacturing issues relating to the modified Pod;

•our achievement of satisfactory development and pricing terms with the pharmaceutical companies that sell such drugs;

•our identification of drug delivery opportunities for a modified Pod;

decrease our gross margins and cause a shortage of product supply.

•our suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements, and

•the occurrence of a fire, natural disaster, or other catastrophe, impacting one or more of our suppliers, may affect their ability to deliver products to us in a timely manner;

Our inventory is produced and maintained in a limited number of locations.

Risks Related to Supply Chain, Operations, and Drug Delivery

•difficulties associated with foreign legal systems, including increased costs associated with enforcing contractual obligations in foreign jurisdictions;

Our financial condition or results of operations may be adversely affected by international business risks.

Following the onset of the COVID-19 pandemic, many employees transitioned to a remote or hybrid work environment, which has increased risks associated with our information technology systems and networks.

Another global pandemic or new variants of COVID-19, and the requirements to take action to help limit the spread of illness, could impact our ability to carry out our business as usual.

Another global pandemic could adversely impact our business and financial condition.

A weakening of macroeconomic conditions may also adversely affect our suppliers, which could result in interruptions in supply.

Such litigation, regardless of its outcome, could result in the expenditure of significant financial resources and the diversion of management’s time and resources.

We may not be able to develop additional proprietary technologies that are patentable, and we cannot ensure that our pending patent applications will result in the issuance of patents to us.

We may be unable to adequately protect our intellectual property rights.

and distribute our products effectively.

The healthcare industry is characterized by continuous technological change, resulting in changing consumer preferences and requirements.

As a result, we may not be able to compete effectively against these companies or their products, which may adversely impact our business.

•greater financial and human resources for product development, sales and marketing, and patent litigation.

•greater experience in conducting research and development, clinical trials, manufacturing, marketing, and obtaining regulatory approval; and

•larger and more established distribution networks;

•established relations with healthcare professionals, customers, and third-party payors;

•different and more complete reimbursement profiles;

•significantly greater name recognition;

In addition, some of our competitors, such as Medtronic, are large, well-capitalized companies with more resources than we have.

reduced market acceptance and sales of our products, which would adversely affect our business, financial condition, and results of operations.

If any of these events occur, our ability to generate revenue could be significantly reduced, which would adversely affect our business, financial condition, and results of operations.

•results of clinical studies relating to Omnipod products or our competitors’ products.

•failure to appropriately forecast the demand, competition, and costs related to markets in which we compete; and

•attrition rates of consumers who cease using Omnipod products;

•the inability of users to continue paying for our products;

•failure to successfully open or expand new facilities;

•damage, destruction or loss of any of the facilities where our products are manufactured or stored or of the equipment therein;

•adverse regulatory or legal actions relating to our Omnipod products;

•claims that any portion of Omnipod products infringes on intellectual property rights of others;

•reductions in reimbursement rates or coverage policies relating to Omnipod products by third-party payors;

•actual or perceived quality problems;