What changed in this filing

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Item 1A. Risk Factors

2026-02-12 compared with 2025-02-18 · 233 added, 183 removed, 1025 unchanged (29% of the section changed)

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Furthermore, additional risks and uncertainties of which we are currently unaware, or which we currently consider to be immaterial, could have a material adverse effect on our business, financial condition or results of operations.

Refer to our disclaimer regarding forward-looking statements at the beginning of Part I, Item 1 of this Annual Report on Form 10-K.

Refer to our disclaimer regarding forward-looking statements at the beginning of this Annual Report on Form 10-K.

Risks Related to Our Business and Operations

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If we experience decreasing prices for our products and we are unable to reduce our expenses, including the per unit cost of producing our products, there may be a material adverse effect on our business, results of operations, financial condition and cash flows.

We have experienced, and anticipate that we will continue to experience, decreasing prices for our products due to pricing pressure from managed care organizations and other third-party payors.

We have experienced, and anticipate that we will continue to experience, decreasing prices for our products due to future reimbursement changes under Medicare and pricing pressure from managed care organizations and other third-party payors.

In the United States and other countries, government and private sector access to health care products continues to be a subject of focus, and efforts to reduce health care costs are being made by third-party payors.

Most of our customers rely on third-party payors, including government programs and private health insurance plans, to cover the cost of the G6, G7 and Dexcom One.

Most of our customers rely on third-party payors, including government programs and private health insurance plans, to cover the cost of the G6, G7, G-7 15 Day, Dexcom One, and Dexcom ONE+.

We expect that these continuing cost reduction and containment measures could result in lower prices for these products and lower reimbursement rates, as well as could lead to patients being unable to obtain approval for coverage or payment from these third-party payors resulting in costs being shifted to patients for these products.

To the extent these cost containment efforts are not offset by greater patient access to our products, our revenue may be reduced and our business may be harmed.

Additionally, we may experience pricing pressure if our products are increasingly subject to competitive bidding processes, which include substantial costs and managerial time to prepare bids and proposals for contracts that may not be awarded to us or may be split among competitors.

For example, in June 2025, the Centers for Medicare & Medicaid Services published a proposed rule that would subject continuous glucose monitors to the competitive bidding process, which could negatively impact our reimbursement and result in price decreases.

In late 2025, CMS extended the DMEPOS competitive bidding program to include our CGMs and receivers, with contracting beginning in 2027 and payment changes taking effect in 2028.

Under the program, DMEPOS suppliers compete to become Medicare contract suppliers by submitting bids to furnish certain items in CBAs.

CMS anticipates that ten (10) contracts will be awarded for CGMs.

However, while the competitive bidding program previously used CBAs for contract awards, CMS determined that for CGMs and certain other DME, a RID CBA was more appropriate.

It remains to be seen whether CGMs will be covered under a single, nationwide RID CBA or whether regional RID CBAs will be established.

In any event, the bid process is expected to result in lower Medicare reimbursement for CGM systems, particularly because CMS is changing the pricing under the RID CBA by setting a single payment amount for covered items at the 75 th percentile of the winning bids, rather than using the maximum winning bid.

Further, CMS has reclassified CGMs and insulin infusion pumps to items that require frequent and substantial servicing and will phase in monthly rental payments for these items.

CMS will bundle the rental amount for the receiver device with payment for the supplies and accessories in the new payment amount.

The bid limit will be monthly fee schedule amounts for the supplies plus the average purchase fee schedule amounts for the CGM receiver device divided by 60 (intended to capture the 5-year useful life of the device.) As a result, we expect that Medicare reimbursement for our CGM systems will decrease beginning in 2028.

CMS is required by law to recompete these contracts at least once every three years and to roll out the competitive bidding process nationally or adjust prices in non-competitive bidding areas to match competitive bidding prices.

The implementation of the competitive bidding program is expected to result in reduced Medicare payment for CGMs in both competitive bidding areas and non-competitive bidding areas.

Additionally, the new bidding system will contain a “country of origin” question to obtain information on where products are manufactured;

however, it is unclear how CMS intends to use this information.

Given that we maintain offshore manufacturing facilities, country of origin reporting could have an impact on our business.

Competitive bidding could negatively impact our reimbursement and result in price decreases.

To the extent these

cost containment efforts are not offset by greater patient access to our products, our revenue may be reduced and our business may be harmed.

On July 4, 2025, President Trump signed the budget reconciliation bill (entitled “One Big Beautiful Bill Act”, or the Bill) to meet spending targets aimed at funding the Administration’s domestic priorities that includes significant changes to the Medicaid program.

Congressional Budget Office, or CBO, preliminary estimates show that the Medicaid provisions would reduce Medicaid spending by $1 trillion and will increase the number of people without health insurance by at least 11.8 million by 2034.

Some key proposed changes to the Medicaid Program include, but are not limited to:

work requirements;

cost sharing of up to $35 per service on expansion adults who exceed the official poverty threshold;

stricter eligibility requirements for non-U.S.

requirements for states to conduct eligibility redeterminations at least every six months for Medicaid expansion adults;

and prohibitions on states from establishing any new provider taxes or from increasing the rates of existing taxes, among other changes.

Decreased federal funding and stricter eligibility requirements may result in more restrictive Medicaid programs at the state level and fewer individuals eligible for coverage, which could have an adverse impact on the number of individuals who seek to use our products and services.

Despite the ACA going into effect over a decade ago, there have been numerous legal and Congressional challenges to the law’s provisions and the effect of certain provisions have made compliance costly.

For instance, changes to the ACA included in the Bill, including shortening enrollment periods and eliminating automatic reenrollment, could reduce ACA enrollment.

We expect material changes in health policy, enforcement initiatives, and coverage and reimbursement for health care items and services from the Trump Administration and Congress.

As such, our costs to monitor these changes and respond to new requirements will increase.

In addition to decreased pricing, we may be unable to reduce our expenses, including the cost of sourcing materials, logistics and the cost to manufacture our products.

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As a medical device company, reimbursement from government and/or commercial third-party healthcare payors, including Medicare and Medicaid, is an important element of our success.

The Centers for Medicare & Medicaid Services, or CMS, provides coverage for “Therapeutic Continuous Glucose Monitors” as durable medical equipment eligible for coverage under Medicare Part B.

CMS provides coverage for “Therapeutic Continuous Glucose Monitors” as durable medical equipment eligible for coverage under Medicare Part B.

Coverage criteria for therapeutic CGMs is determined by CMS under national coverage determinations as well as by local Medicare Administrative Contractors under local coverage determinations.

Therefore, Medicare reimbursement for our CGM devices is subject to various coverage conditions and often requires a patient-specific coverage analysis.

Medicare does not cover any items or services that are not “reasonable and necessary.” Medicare covers the CGM system, which includes supplies necessary for the use of the device, under the Durable Medical Equipment, or DME, benefit category.

In order to be covered under this benefit, one component of the CGM system must meet the criteria for a durable medical device.

To date, the receiver satisfied this criteria.

Medicare does not cover any items or services that are not “reasonable and necessary.” In order to be covered under the DME benefit, one component of the CGM system must meet the criteria for a durable medical device.

To date, the receiver satisfied these criteria.

To the extent that a receiver is not used by a Medicare beneficiary or CMS otherwise determines that the items and supplies ordered are not medically necessary, Medicare may not cover that CGM system or any associated supplies.

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Among other things, people with diabetes without insurance that covers our products bear the entire financial cost of using our products.

In addition, in the United States, existing single-point finger stick devices used by people with diabetes are generally reimbursable for all or part of the product cost by Medicare or other third-party payors, which may be perceived as more advantageous for consumers.

In addition, in the

United States, existing single-point finger stick devices used by people with diabetes are generally reimbursable for all or part of the product cost by Medicare or other third-party payors, which may be perceived as more advantageous for consumers.

Further, while many third-party payors have adopted some form of coverage policy on CGM devices, in a sizeable percentage of cases, under durable medical equipment benefits, those coverage policies frequently are restrictive and require significant medical documentation and other requirements in order to obtain reimbursement, and as a result, we have difficulty improving the efficiency of our customer service group.

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This final rule expanded coverage of CGMs to include competing devices, which may continue to have a negative impact on our sales as a result of increased market competition.

In addition, 2025 will bring a new presidential administration, which may shift health policy priorities, including potential impacts on Medicare coverage and reimbursement.

In addition, the change in presidential administration in 2025 has caused and may continue to cause shifts in health policy priorities, including potential impacts on Medicare coverage and reimbursement.

As discussed above, the Bill included significant changes to federal Medicaid funding and ACA enrollment requirements, all of which are expected to result in decreased Medicaid reimbursement and loss of coverage for individuals under Medicaid and ACA plans.

We are unable to predict what effect the current or any future healthcare reform will have on our business, or the effect these matters will have on our customers.

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Furthermore, payors are increasingly basing reimbursement rates on factors such as prior approvals and the effectiveness of the product, clinical outcomes associated with the product, and any factors that negatively impact the effectiveness or clinical outcomes (or cause a perception of any such negative impact), such as the results of a clinical trial, a product defect, or a product recall, which could negatively impact the reimbursement rate.

Also, the trends toward managed healthcare in the United States, which we expect to continue in 2025 and beyond, and legislative efforts intended to reduce the cost of

government insurance programs could significantly influence the purchase of healthcare services and products and may result in lower prices for our products or the exclusion of our products from reimbursement programs.

Also, the trends toward managed healthcare in the United States, which we expect to continue, and legislative efforts intended to reduce the cost of government insurance programs could significantly influence the purchase of healthcare services and products and may result in lower prices for our products or the exclusion of our products from reimbursement programs.

In many international markets, pricing and profitability of medical devices are subject to government control.

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Even if a product receives marketing authorization from the FDA or comparable international regulator, it may not be accepted in the marketplace by health care professionals, people with diabetes and those seeking to optimize metabolic health.

In the ordinary course of our business we enter into collaborative arrangements with third parties to expand into new markets, including with insulin device manufacturers to integrate our CGM technology into the third parties’ insulin delivery systems.

In the ordinary course of business, we enter into collaborative arrangements with third parties to expand into new markets, including with insulin device manufacturers to integrate our CGM technology into the third parties’ insulin delivery systems.

We have also entered into collaborations with several organizations that are currently using, or are developing, programs for the treatment of Type 2 diabetes that utilize our current CGM systems.

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Many of the companies that we collaborate with are also competitors or potential competitors who may decide to terminate our collaborative arrangement.

In the event of such a termination, we may be required to devote

additional resources to product development and commercialization, we may need to cancel some development programs and we may face increased competition.

In the event of such a termination, we may be required to devote additional resources to product development and commercialization, we may need to cancel some development programs and we may face increased competition.

Additionally, collaborations may not result in the development of products that achieve commercial success and could be terminated prior to developing any products.

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We expect that sales of our CGM systems will account for substantially all of our product revenue for the foreseeable future.

If and when we receive FDA or other regulators’ marketing authorization for, and begin commercialization of, our next-generation CGM systems, we expect most patients will migrate onto those systems.

If and when we receive FDA or other regulators’ marketing authorization for, and begin

commercialization of, our next-generation CGM systems, we expect most patients will migrate onto those systems.

In the periods leading up to the launch of new or upgraded versions of our CGM systems, however, our customers’ anticipation of the release of those products may cause them to cancel, change or delay current period purchases of our current products, which could have a material adverse effect on our business, financial condition and results of operations.

Notwithstanding our prior experience in marketing and selling our products, we might be unable to successfully expand the commercialization of our existing products or begin commercialization of our next-generation CGM systems on a wide-scale for a number of reasons, including the following:

• our G6 and G7 systems prompt the user to replace the sensor no later than the tenth day, which might make it expensive for users;

• our G6 and G7 systems prompt the user to replace the sensor no later than the tenth day, and our G7 15 Day prompts the user to replace the sensor no later than the fifteenth day, which might make it expensive for users;

• widespread market acceptance of our products by health care professionals, people with diabetes and those seeking to optimize metabolic health will largely depend on our ability to demonstrate their relative safety, effectiveness, reliability, cost-effectiveness and ease of use;

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• expanded coverage opportunities for our competitors’ CGM devices and supplies, including coverage for adjunctive CGMs, increasing competition in the marketplace;

• loss or reduction of insurance coverage for individuals, resulting in higher cost obligations for users with respect to their purchase of our products;

• our FDA and other regulatory authority marketing application submissions and reviews may be delayed, or cleared or approved with limited product indications and labeling;

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• rapid technological change may make our technology and our products obsolete.

In addition to the risks outlined above, our G6, G7, Dexcom One, and Stelo systems are more invasive than many other self-monitored glucose testing systems, including single-point finger stick devices, and people with diabetes and those seeking to optimize metabolic health may be unwilling to insert a sensor in their body, especially for those with diabetes if their current diabetes management involves no more than two finger sticks per day.

people with diabetes and those seeking to optimize metabolic health may not perceive the benefits of CGM and people with diabetes may be unwilling to change their current treatment regimens.

In addition to the risks outlined above, our CGMs are more invasive than many other self-monitored glucose testing systems, including single-point finger stick devices, and people with diabetes and those seeking to optimize metabolic health may be unwilling to insert a sensor in their body, especially for those with diabetes if their current diabetes management involves no more than two finger sticks per day.

Moreover, people with diabetes and those seeking to optimize metabolic health may not perceive the benefits of CGM and people with diabetes may be unwilling to change their current treatment regimens.

Health care professionals may not recommend or prescribe our products unless and until (i) there is more long-term clinical evidence to convince them to alter their existing treatment methods, (ii) there are additional recommendations from prominent physicians that our products are effective in monitoring glucose levels, (iii) reimbursement or insurance coverage is more widely available, and (iv) patient out of pocket cost decreases.

In addition, market acceptance of our products internationally by health care professionals and people with diabetes and those seeking to optimize metabolic health will largely depend on our ability to demonstrate their relative safety, effectiveness, reliability, cost-effectiveness and ease of use.

If we are unable to do so, we may not be able to generate product revenue from our international sales efforts.

unable to do so, we may not be able to generate product revenue from our international sales efforts.

We cannot predict when, if ever, healthcare professionals, including physicians, and people with diabetes and those seeking to optimize metabolic health may adopt more widespread use of CGM systems, including our systems.

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While we believe that GLP-1s are a companion product and used in conjunction with our CGM systems, these treatments could potentially compete with our CGM systems and reduce sales of our products.

We are also aware of companies outside the traditional medical device sector that are attempting to develop competitive products and services, including for the general health and wellness, or population health space.

Some of the companies developing or marketing competing devices are large and well-known publicly traded companies.

Such competitors may benefit from guidance issued on January 6, 2026 by the FDA’s Center for Devices and Radiological Health that effectively broadens the range of products that may be considered “general wellness devices,” including wearables that provide readings around bodily functions and vital signs such as heart rate, blood pressure, and blood glucose.

If our CGM systems do not achieve and maintain an adequate level of acceptance by people with diabetes, those seeking to optimize metabolic health, healthcare professionals, including physicians, and third-party payors, our future revenue may be reduced and our business may be harmed.

Risks Related to Manufacturing, Commercial Operations and Commercialization

If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, including responding to the FDA warning letter, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market.

Any products for which we obtain marketing approval, clearance or authorization (and the activities related to its production, distribution, and promotion, sale, and marketing) are subject to continual review and periodic inspections by the FDA and other regulatory bodies, which may include inspection of our manufacturing processes, complaint handling and adverse event reporting, post-approval clinical data and promotional activities for such product.

The FDA’s medical device reporting regulations require that we report to the FDA any incident in which our product may have caused or contributed to a death or serious injury, or in which our product malfunctioned and, if the malfunction were to recur, it would likely cause or contribute to a death or serious injury.

If the FDA determines that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the agency may issue a cease distribution and notification order and a mandatory recall order.

We may also decide to recall a product voluntarily if we find a material deficiency, including unacceptable risks to health, manufacturing defects, design errors, component failures, labeling defects, or other issues.

Recalls of our products could divert the attention of our management and have an adverse effect on our reputation, financial condition, and operating results.

We and certain of our suppliers are also required to comply with the FDA’s Quality System Regulation, or QSR, which as stated above is being superseded by the new QSMR, and other regulations which cover the methods and documentation of the design, testing, production, control, selection and oversight of suppliers or contractors, quality assurance, labeling, packaging, storage, complaint handling, shipping and servicing of our products.

The FDA may enforce the QSR and in the future the QMSR through announced (through prior notification) or unannounced inspections, such as the inspections described below.

Compliance with ongoing regulatory requirements can be complex, expensive and time-consuming.

Failure by us or one of our suppliers or distributors to comply with statutes and regulations administered by the FDA, competent authorities and other regulatory bodies, or failure to take adequate response to any observations, including the warning letter described below, could result in, among other things, any of the following actions:

• warning letters or untitled letters that require corrective action;

• delays in approving, or refusal to approve, our CGM systems;

• fines and civil or criminal penalties;

• unanticipated expenditures;

• FDA refusal to issue certificates to international governments needed to export our products for sale in other countries;

• suspension or withdrawal of clearance or approval by the FDA or other regulatory bodies;

• product recall or seizure;

• administrative detention;

• interruption, partial suspension, or complete shutdown of production;

• interruption of the supply of components from our key component suppliers;

• operating restrictions;

• court consent decrees;

• FDA orders to repair, replace, or refund the cost of devices;

• injunctions;

• criminal prosecution.

From time to time, the FDA conducts inspections of our facilities and may issue Form 483 findings related to our operations and may issue warning letters or take other administrative or enforcement actions asserting noncompliance with FDA laws and regulations.

In March 2025, we received an FDA warning letter following inspections of our facilities in San Diego, California, and Mesa, Arizona.

In the warning letter, the FDA cited deficiencies in the response letters sent by us to the FDA following the Form 483, List of Investigational Observations that was delivered to us in connection with the inspection of our San Diego, California facility that occurred from October 2024 through November 2024, and the inspection of our Mesa, Arizona facility that occurred in June 2024.

The warning letter describes observed non-conformities in manufacturing processes and our quality management system.

We take the matters identified in the warning letter seriously and have submitted responses to the Form 483 and to the FDA warning letter.

While the warning letter does not restrict our ability to produce, market, manufacture or distribute products, require recall of any products, nor restrict our ability to seek FDA 510(k) clearance of new products, we may fail to satisfy these regulatory requirements to the FDA’s satisfaction, and any failure to do so could result in the foregoing occurring.

While we intend to undertake certain corrective actions and provide regular updates to the FDA in order to meet the requirements set forth by FDA in the warning letter, we cannot give any assurances that the FDA will be satisfied with our response or as to the date we expect to resolve the matters included in the FDA warning letter.

Until the issues cited in the warning letter are resolved to the FDA’s satisfaction, additional legal or regulatory action may be taken without further notice, including as described above.

The potential effect of the warning letter and these other events can in some cases be difficult to quantify and could harm our reputation and cause our product sales and profitability to suffer.

In addition, we believe events that could be classified as reportable events pursuant to FDA medical device reporting regulations are generally underreported by physicians and users, and any underlying problems could be of a larger magnitude than suggested by the number or types of FDA medical device reports filed by us.

Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements.

If we obtain regulatory approval to market and sell a product, the FDA or a foreign regulatory authority may still impose significant restrictions on the indicated uses or how the product may be marketed, or may contain requirements for costly post-marketing testing or surveillance to monitor the safety or effectiveness of the product.

Later discovery of previously unknown problems with our products, including software bugs, unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as the QSR which as stated above is being superseded by the new QSMR, FDA medical device reporting, or other post-market requirements may result in restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls (through corrections or removals), fines, suspension of regulatory approvals, product seizures, injunctions, the imposition of civil or criminal penalties, or criminal prosecution.

In addition, our distributors have rights to create marketing materials for their sales of our products, and may not adhere to contractual, legal or regulatory limitations that are imposed on their marketing efforts.

Notably, the new bidding system for Medicare competitive bidding will contain a “country of origin” question to obtain information about where products are manufactured.

It is unclear how CMS intends to use this information and what impact this could have, if any, on our offshore manufacturing activities.

If our manufacturing capabilities are insufficient to produce an adequate supply of product at appropriate quality levels, our growth could be limited and our business could be harmed.

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From time to time, we have also experienced periods of backorder where we have had insufficient supply of our product and, at times, have had to limit the efforts of our sales force to introduce our products to new customers.

We have recently experienced manufacturing and inventory challenges for G7 that have resulted, and may continue to result from time to time, in disruptions in our ability to supply certain markets, including in the U.S.

We have experienced manufacturing and inventory challenges for G7 in the past that resulted in disruptions in our ability to supply certain markets, including in the U.S.

and other countries.

While we are currently working to remedy such challenges, we cannot predict when such manufacturing and inventory challenges will be remedied.

If we fail to produce a sufficient amount of our products, our ability to supply our markets will be compromised and health care providers and people with diabetes’ decisions to use our products may be negatively impacted.

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Moreover, we may not adequately predict the market demand for our products, which may lead us to produce our products in the quantities we anticipate will be necessary to meet actual market demand.

We will need to adequately predict the market demand for our products, remedy our recent manufacturing challenges, and increase our manufacturing capacity by a significant factor over the current level to meet or exceed the anticipated market demand by product.

We will need to adequately predict the market demand for our products and increase our manufacturing capacity by a significant factor over the current level to meet or exceed the anticipated market demand by product.

In addition, we may have to modify our manufacturing design, reliability and process for next-generation products that may hereafter be approved, cleared or otherwise authorized by the applicable regulatory body and commercialized.

In 2023, we completed the initial phase of construction of our new facility in Malaysia and commenced commercial manufacturing.

We also commenced construction of a new facility in Ireland to scale up manufacturing capacity.

We are also building a new facility in Ireland to scale up manufacturing capacity.

There are technical challenges to increasing manufacturing capacity, including equipment design, automation, validation and installation, contractor issues and delays, licensing and permitting delays or rejections, materials procurement, manufacturing site expansion, problems with production yields and quality control and assurance.

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Delays in the launch of next-generation products may result in unanticipated continuing increases in demand for current-generation products (to substitute for the unavailability of the next-generation products) which, if not adequately prepared for, may result in deficits in our ability to produce adequate amounts of the prior-generation products to meet demand at appropriate prices.

install and maintain manufacturing equipment, among others, all of which can lead to unexpected delays in manufacturing output.

Our ability to scale manufacturing capacity is subject to numerous risks and uncertainties, and may lead to variability in product quality or reliability, increased construction timelines, as well as resources required to design, install and maintain manufacturing equipment, among others, all of which can lead to unexpected delays in manufacturing output.

In addition, any changes to our manufacturing processes may trigger the need for submissions or notifications to, and in some cases advance approval from, the FDA or other regulatory authorities because of the potential impact of changes on our previously cleared, approved and/or authorized devices.

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Problems with these manufacturing processes, which may not be detectable by us in a timely manner, could lead to product defects or manufacturing failures, resulting in lot failures, product recalls, product liability claims and/or insufficient inventory, any of which could negatively impact our sales.

As further described in the risk factor above, we have recently experienced manufacturing and inventory challenges that have resulted, and may continue to result from time to time, in disruptions in our ability to supply certain markets, including in the U.S.

and other countries.

In addition, our products are manufactured at certain facilities, with limited alternate facilities.

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Because of the time required to approve, lease, and build out a manufacturing facility, an alternate facility and/or a third-party may not be available on a timely basis to replace production capacity in the event manufacturing capacity is lost.

Additionally, the majority of our operations are conducted at facilities located in San Diego, California, Mesa, Arizona, and Malaysia.

Additionally, the majority of our manufacturing operations are conducted at facilities located in Mesa, Arizona, and Malaysia and limited manufacturing operations in San Diego, California.

We take precautions to safeguard our facilities, which include manufacturing protocols, insurance, health and safety protocols, and off-site storage of data.

However, a natural or man-made disaster, such as fire, flood, earthquake, act of terrorism, cyber-attack or other disruptive event, such as a public health emergency, could cause substantial delays in our operations, damage, destroy or limit our manufacturing equipment, inventory, or records and cause us to incur additional expenses.

Earthquakes are of particular significance since our manufacturing facilities in California are located in an earthquake-prone area.

Wildfires are also increasingly common in southern California and present risk to our manufacturing operations.

destroy or limit our manufacturing equipment, inventory, or records and cause us to incur additional expenses.

Earthquakes are of particular significance since our headquarters and limited manufacturing facilities in California are located in an earthquake-prone area.

Wildfires are also increasingly common in southern California and present risk to our headquarters and limited manufacturing operations in San Diego, California.

Our Arizona facility may confront water supply issues resulting from the ongoing drought in the Western United States and our Malaysia facility may confront issues related to its construction on a reclaimed wetland and the political stability of the Malaysia government.

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The insurance we maintain against fires, floods, earthquakes and other natural disasters and similar events may not be adequate to cover our losses in any particular case.

If we experience manufacturing difficulties or disruptions, or if we fail to remedy our recent manufacturing and inventory challenges, it could result in insufficient inventory, increased costs, immediate shortages in product or component supply, and decreased sales, any of which may harm our business.

If we experience manufacturing difficulties or disruptions, it could result in insufficient inventory, increased costs, immediate shortages in product or component supply, and decreased sales, any of which may harm our business.

We depend upon third-party suppliers and outsource to other parties, making us vulnerable to supply disruptions, suboptimal quality, non-compliance and/or price fluctuations, which could harm our business.

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However, we also rely on single and/or sole sources for certain components and materials used in manufacturing, such as for the application-specific integrated circuit that is incorporated into the transmitter and certain polymers used to synthesize the polymeric biointerface membranes for our products.

In some cases, our agreements with these and other suppliers can be terminated by

either party upon short notice.

In some cases, our agreements with these and other suppliers can be terminated by either party upon short notice.

Our contract manufacturers may also rely on single- or sole-source suppliers to manufacture some of the components used in our products.

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• we may have difficulty locating and qualifying alternative suppliers for our single-source supplies;

• switching components may require product redesign and submission to the FDA or international regulator of new applications (such as new 510(k) submissions or PMA supplements) which could significantly delay production;

delay production;

• our suppliers manufacture products for a range of customers, and fluctuations in demand for the products these suppliers manufacture for others may affect their ability to deliver components to us in a timely manner or at the current pricing;

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We also require the suppliers, service providers and business partners of components or services for our products and related services to comply with law and certain of our policies regarding sourcing practices, but we do not control them or their practices.

If any supplier, service provider or business partner violates laws or implements unethical practices, there could be disruptions to our supply chain, cancellation of our orders, a termination of the relationship with the partner or damage to our reputation, and the FDA or other regulators could seek to hold us responsible for such violations.

If any supplier, service provider or business partner violates laws or implements unethical practices, there could be disruptions to our supply chain, cancellation of our orders, or a termination of the relationship with the partner or damage to our reputation, and the FDA or other regulators could seek to hold us responsible for such violations.

If we are unable to establish and maintain adequate sales, marketing and distribution capabilities and/or enter into and maintain arrangements with third parties to sell, market and distribute our products, we may have difficulty achieving market awareness and selling our products in the future.

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We have also entered into distribution arrangements to leverage existing distributors (including wholesalers) already engaged in the distribution of drugs, devices and/or products in the diabetes marketplace.

Some of our U.S distributors are focused on accessing underrepresented regions and or third-party payors that contract exclusively with distributors in the United States, while some of our international distributors call directly on healthcare providers and patients to market and sell our products.

and patients to market and sell our products.

Because of the competition for their services, we may be unable to partner with or retain additional qualified distributors.

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Therefore, our products may be rendered obsolete by technological breakthroughs in diabetes monitoring, treatment, prevention or cure.

In selling our G6, G7 and Dexcom One, we compete directly with the Diabetes Care division of Abbott Laboratories;

Medtronic plc’s Diabetes Group;

In selling our G6, G7, G7 15 Day, Dexcom One and Dexcom ONE+, we compete directly with the Diabetes Care division of Abbott Laboratories;

Medtronic (MiniMed);

Roche Diabetes Care, a division of Roche Diagnostics;

privately-held LifeScan, Inc.;

and Ascensia Diabetes Care, each of which manufactures and markets products for the single-point finger stick device market.

Ascensia Diabetes Care;

and other smaller market entrants, each of which manufactures and markets products for the single-point finger stick device market.

In selling Stelo, we compete directly with the Diabetes Care division of Abbott Laboratories.

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We have competed with Abbott for several years and their Libre family of CGM products.

Medtronic markets and sells one or more standalone glucose monitoring products both internationally and in the United States.

Medtronic and other third parties have developed or are developing insulin pumps integrated with CGM systems that provide, among other things, the ability to suspend insulin administration while the user’s glucose levels are low and to automate basal and bolus insulin dosing.

Medtronic (MiniMed) markets and sells a standalone glucose monitoring product called Guardian Connect, both internationally and in the United States, and a disposable CGM system called Simplera in the U.S.

and international markets.

Medtronic (MiniMed) and other third parties have developed or are developing insulin pumps integrated with CGM systems that provide, among other things, the ability to suspend insulin administration while the user’s glucose levels are low and to automate basal and bolus insulin dosing.

Likewise, Abbott Diabetes Care has received FDA clearance to integrate certain versions of their Libre sensors into automated insulin delivery systems and is pursuing such integrations with third-party insulin delivery devices.

We are also aware of companies outside the traditional medical device sector that are attempting to develop competitive products and services, including for general health and wellness, or population health.

We are also aware of the increasing use of GLP-1 products for the treatment of obesity and Type 2 diabetes.

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Moreover, the tax laws in which we and our subsidiaries do business could change on a prospective or retroactive basis, and any such changes could adversely affect our business and financial condition.

We have a significant presence in the European Union, as well as significant sales in the European Union, such that any changes in tax laws in the European Union could impact our business.

The overall impact of such legislation in European Union member states is uncertain, and our business and financial condition could be adversely affected by any laws impacting our tax rate.

We have a significant presence in the EU, as well as significant sales in the EU, such that any changes in tax laws in the EU could impact our business.

The overall impact of such legislation in EU member states is uncertain, and our business and financial condition could be adversely affected by any laws impacting our tax rate.

While it is impossible for us to predict whether these and other proposals will be implemented, or how they will ultimately impact us, they may materially impact our results of operations if, for example, our profits earned abroad are subject to U.S.

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We cannot predict changes in currency exchange rates, the impact of exchange rate changes, nor the degree to which we will be able to manage the impact of currency exchange rate changes.

Following a 2016 referendum of voters in the United Kingdom, or the U.K, to exit from the European Union, or the E.U., the U.K.

Following a 2016 referendum of voters in the United Kingdom, or the U.K., to exit from the EU, or the E.U., the U.K.

left the E.U.

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Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of the trade and cooperation agreement or otherwise, could prevent us from marketing our CGM systems in the U.K.

and/or the E.U.

and restrict our ability to generate revenue and achieve and sustain profitability.

and/or the EU and restrict our ability to generate revenue and achieve and sustain profitability.

Under the trade and cooperation agreement, U.K.

service suppliers no longer benefit from automatic access to the entire E.U.

single market, U.K.

service suppliers no longer benefit from automatic access to the entire EU single market, U.K.

goods no longer benefit from the free movement of goods and there is no longer the free movement of people between the U.K.

Depending on the application of the terms of the trade and cooperation agreement, we could face new regulatory costs and challenges which could have a material adverse effect on our business, results of operations, or financial condition.

and the EU Depending on the application of the terms of the trade and cooperation agreement, we could face new regulatory costs and challenges which could have a material adverse effect on our business, results of operations, or financial condition.

Laws and regulations governing the export of our products could adversely impact our business.

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In addition, the government agencies may seek to hold us liable for successor liability for anti-corruption law violations committed by any companies in which we invest or that we acquire.

Any alleged or actual violations of these regulations may subject us to government scrutiny, severe criminal or civil sanctions and other liabilities, including exclusion from government

contracting, and could disrupt our business, and result in a material adverse effect on our business, financial condition, and results of operations.

Any alleged or actual violations of these regulations may subject us to government scrutiny, severe criminal or civil sanctions and other liabilities, including exclusion from government contracting, and could disrupt our business, and result in a material adverse effect on our business, financial condition, and results of operations.

Current uncertainty in global economic and political conditions makes it particularly difficult to predict product demand and other related matters and makes it more likely that our actual results could differ materially from expectations.

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We may not obtain international regulatory authorizations or approvals on a timely basis, if at all.

Obtaining a marketing authorization from the FDA does not ensure authorization or approval by regulatory authorities in other countries will follow, and authorization or approval by one international regulatory authority does not ensure authorization or approval by regulatory authorities in other international jurisdictions or by the FDA.

Obtaining a marketing authorization from the FDA does not ensure authorization or approval by regulatory authorities in other countries will follow, and authorization or approval

by one international regulatory authority does not ensure authorization or approval by regulatory authorities in other international jurisdictions or by the FDA.

In addition, in order to obtain the authorization to market our products in certain international jurisdictions, in some cases we may need to obtain a Certificate to Foreign Government from the FDA.

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We are subject to a number of international, federal and state laws and regulations protecting the use, disclosure, and confidentiality of certain patient and consumer health and personal information, including patient records, and restricting the use and disclosure of that protected information, including state breach notification laws.

Some of these laws include the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, the European Union’s General Data Protection Regulation, or GDPR, the UK Data Protection Act and the UK GDPR, the California Consumer Privacy Act as amended, or CCPA, and the Washington My Health My Data Act, among others.

Some of these laws include the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, the EU’s General Data Protection Regulation, or GDPR, the UK Data Protection Act and the UK GDPR, the California Consumer Privacy Act as amended, or CCPA, and the Washington My Health My Data Act, among others.

state laws and regulations may also require us to notify affected individuals and state regulators in the event of a data breach involving personal information.

Penalties for failure to adequately protect personal information, notify as required, or provide timely notice vary by jurisdiction.

In the U.S., most state data breach notification laws consider violations to be unfair or deceptive trade practices and give the relevant state attorneys general (“AGs”) the authority to levy fines or bring enforcement actions.

In the United States, most state data breach notification laws consider violations to be unfair or deceptive trade practices and give the relevant state attorneys general (“AGs”) the authority to levy fines or bring enforcement actions.

Such AG investigations—which are often time-consuming, expensive, and burdensome—could lead to a resolution agreement, whereby certain obligations are performed and reports are made to the AG for a period of time, and/or civil penalties.

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The secure processing, maintenance and transmission of this information is critical to our operations.

Despite our security measures and business controls, our information technology and infrastructure may be vulnerable to attacks by hackers (including nation states or state-sponsored organizations), viruses, malware, breaches due to employee, contractor or vendor error, or malfeasance or other disruptions or subject to the inadvertent or intentional unauthorized release of information.

Despite our security measures and business controls, our information technology and infrastructure may be vulnerable to attacks by hackers (including nation states or

state-sponsored organizations), viruses, malware, breaches due to employee, contractor or vendor error, or malfeasance or other disruptions or subject to the inadvertent or intentional unauthorized release of information.

Any such occurrence could compromise our networks and the information stored thereon could be accessed, publicly disclosed, lost or stolen.

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The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

In addition, other states have, or may, enact similar legislation.

It remains unclear what, if any, additional modifications will be made to this legislation or how it will be interpreted.

In addition, other states have enacted, or may enact, similar legislation.

The effects of the CCPA and other state privacy laws are significant and have required us to modify our data processing practices, and may cause us to incur substantial costs and expenses to comply, particularly given our base of operations in California.

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laws, including in particular the laws of Europe.

For instance, in the European Union, increasingly stringent data protection and privacy rules that have and will continue to have substantial impact on the use of patient data across the healthcare industry became effective in

The GDPR applies across the European Union and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

The GDPR fine framework can be up to 20 million euros, or up to 4% of the company’s total global turnover of the preceding fiscal year, whichever is higher.

The GDPR also requires companies processing personal data of individuals residing in the European Union to comply with EU privacy and data protection rules, even if the company itself does not have a physical presence in the European Union.

For instance, in the EU, increasingly stringent data protection and privacy rules that have and will continue to have substantial impact on the use of patient data across the healthcare industry became effective in May 2018.

The GDPR applies across the EU and European Economic Area and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

Fines under GDPR can be up to 20 million euros, or up to 4% of the company’s total global turnover of the preceding fiscal year, whichever is higher.

The GDPR also requires companies processing personal data of individuals residing in the EU and European Economic Area to comply with EU privacy and data protection rules in certain circumstances, even if the company itself does not have a physical presence in the EU.

Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities.

Due to the strong consumer protection aspects of the GDPR, companies subject to its purview are allocating substantial legal costs to the development of necessary policies and procedures and overall compliance efforts.

Due to the strong consumer protection aspects of the GDPR, companies subject to its purview are allocating substantial legal costs to the development and maintenance of necessary policies and procedures and overall compliance efforts.

Data transfer risk remains a potential issue as certain Data Protection Authorities continue to raise concerns about the transfer of data to the United States.

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The hybrid workplace does, however, introduce additional operational risk, including increased cybersecurity risk.

These cyber risks include, among other risks, increased phishing, malware, and other cybersecurity attacks, vulnerability to, or disruptions of, our information technology infrastructure and systems to support remote operations, increased risk of unauthorized access, use or dissemination of confidential information, limited ability to restore the systems in the event of a systems failure or interruption, greater risk of a security breach resulting in destruction, alteration or misuse of valuable information, including proprietary business information and personally identifiable information of individuals, all of which could expose us to risks of data or financial loss, litigation and liability.

information, limited ability to restore the systems in the event of a systems failure or interruption, greater risk of a security breach resulting in destruction, alteration or misuse of valuable information, including proprietary business information and personally identifiable information of individuals, all of which could expose us to risks of data or financial loss, litigation and liability.

These threats can come from a variety of sources, including criminal hackers, state-sponsored intrusions, industrial espionage and malfeasance by employees, contractors, or other insiders.

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Unauthorized parties may also attempt to gain access to our systems or facilities through fraud, trickery or other forms of deceiving our employees, contractors and temporary staff.

Moreover, we are subject to various operational, compliance, and reputational risks associated with our adoption and utilization of AI technologies, including inaccurate or unpredictable outputs, such as errors or hallucinations, that may impair decision‑making, disrupt operations, or expose sensitive information.

Integrating AI into our systems may also expand our cybersecurity attack surface, increasing exposure to data breaches, loss of intellectual property, or inadvertent disclosure of confidential data.

Although we have taken steps intended to mitigate risks related to our use of AI, there can be no assurance that our use of AI will yield the anticipated benefits or that we will be able to effectively mitigate the associated risks.

Externally, the rapid adoption of AI by competitors and malicious actors heightens risks as threat actors leverage AI to execute more sophisticated cyberattacks and social‑engineering campaigns, while competitor use of AI may accelerate innovation cycles and intensify competitive pressures.

Any of these events could have a material adverse effect on our business, financial condition and results of operations.

While we maintain cybersecurity insurance coverage there is no guarantee that it will be sufficient to cover the financial, legal, business, or reputational losses that may result from an interruption or breach of our systems.

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Failure to protect our information technology infrastructure against cyberattacks, network security breaches, service interruptions, or data corruption could significantly disrupt our operations and adversely affect our business and operating results.

including sales, billing, customer service, procurement and supply chain, manufacturing, and distribution.

We rely on information technology and telephone networks and systems, including the Internet, to process and transmit sensitive electronic information and to manage or support a variety of business processes and activities, including sales, billing, customer service, procurement and supply chain, manufacturing, and distribution.

We use enterprise information technology systems to record, process, and summarize financial information and results of operations for internal reporting purposes and to comply with regulatory financial reporting, legal, and tax requirements.

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If our operations are found to violate any of the international, federal, state or local laws and regulations which govern our activities, we may be subject to litigation, government enforcement actions, and applicable penalties associated with the violation, potentially including civil and criminal penalties, damages, fines, exclusion from participation in certain payor programs or curtailment of our operations.

Compliance obligations under these various laws are oftentimes detailed and onerous, further contributing to the risk that we could be found to be out of compliance with particular requirements.

Compliance obligations under these various laws are oftentimes detailed

and onerous, further contributing to the risk that we could be found to be out of compliance with particular requirements.

The risk of being found in violation of these laws and regulations is further increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, particularly with respect to new and emerging technologies and remote delivery of services, and their provisions are open to a variety of interpretations.

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While we make every effort to comply with applicable laws, we cannot rule out the possibility that the government or other third parties could interpret these laws differently and challenge our practices under one or more of these laws.

such laws, and potentially be awarded a share of any damages or penalties ultimately awarded to the applicable government body.

This likelihood of allegations of non-compliance is increased by the fact that under certain federal and state laws applicable to our business, individuals may bring an action on behalf of the government alleging violations of such laws, and potentially be awarded a share of any damages or penalties ultimately awarded to the applicable government body.

The FDA and the FTC share oversight of medical device promotion.

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On January 10, 2025, HHS released its AI Strategic Plan which largely focuses on promoting trustworthy AI through the FAVES framework (Fair, Appropriate, Valid, Effective, Safe).

Additionally, the EU AI Act went into effect on August 1, 2024, which sets requirements for developers and deployers of AI systems based on a risk approach and extends its reach to those developers of AI outside of the EU where the AI product or output is used in the EU.

Among other adopted requirements, the EU AI Act went into effect on August 1, 2024, which sets requirements for developers (providers) and deployers of AI systems based on a risk approach and extends its reach to those developers of AI outside of the EU where the AI product or output is used in the EU.

AI regulation is continually evolving at the federal, state and international level and will continue to require financial and resource investment by us to ensure that AI tools are safe and effective, operate in a non-discriminatory manner, and comply with applicable legal and regulatory requirements.

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Also, the regulatory environment applicable to our business may change in a way that restricts or adversely impacts our operations.

If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market.

Any product for which we obtain marketing approval, clearance or authorization (and the activities related to its production, distribution, and promotion, sale, and marketing) will be subject to continual review and periodic inspections by the FDA and other regulatory bodies, which may include inspection of our manufacturing processes, complaint handling and adverse event reporting, post-approval clinical data and promotional activities for such product.

The FDA’s Medical Device Reporting, or MDR, regulations require that we report to the FDA any incident in which our product may have caused or contributed to a death or serious injury, or in which our product malfunctioned and, if the malfunction were to recur, it would likely cause or contribute to a death or serious injury.

Recalls of our products could divert the attention of our management and have an adverse effect on our reputation, financial condition, and operating results.

We and certain of our suppliers are also required to comply with the FDA’s Quality System Regulation, or QSR, and other regulations which cover the methods and documentation of the design, testing, production, control, selection and oversight of suppliers or contractors, quality assurance, labeling, packaging, storage, complaint handling, shipping and servicing of our products.

The FDA may enforce the QSR through announced (through prior notification) or unannounced inspections.

Compliance with ongoing regulatory requirements can be complex, expensive and time-consuming.

Failure by us or one of our suppliers or distributors to comply with statutes and regulations administered by the FDA, competent authorities and other regulatory bodies, or failure to take adequate response to any observations, could result in, among other things, any of the following actions:

• warning letters or untitled letters that require corrective action;

• delays in approving, or refusal to approve, our CGM systems;

• fines and civil or criminal penalties;

• unanticipated expenditures;

• FDA refusal to issue certificates to international governments needed to export our products for sale in other countries;

• suspension or withdrawal of clearance or approval by the FDA or other regulatory bodies;

• product recall or seizure;

• administrative detention;

• interruption of production, partial suspension, or complete shutdown of production;

• interruption of the supply of components from our key component suppliers;

• operating restrictions;

• court consent decrees;

• FDA orders to repair, replace, or refund the cost of devices;

• injunctions;

• criminal prosecution.

The potential effect of these events can in some cases be difficult to quantify.

If any of these actions were to occur, it would harm our reputation and cause our product sales and profitability to suffer.

In addition, we believe events that could be classified as reportable events pursuant to MDR regulations are generally underreported by physicians and users, and any underlying problems could be of a larger magnitude than suggested by the number or types of MDRs filed by us.

Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements.

Even if regulatory approval or clearance of a product is granted, the approval or clearance may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for costly post-marketing testing or surveillance to monitor the safety or effectiveness of the product.

Later discovery of previously unknown problems with our products, including software bugs, unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as the QSR, MDR reporting, or other post-market requirements may result in restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls (through corrections or removals), fines, suspension of regulatory approvals, product seizures, injunctions, the imposition of civil or criminal penalties, or criminal prosecution.

Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

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In March 2018, via the de novo process, the FDA classified the G6 and substantially equivalent devices of this generic type (i.e., “integrated continuous glucose monitoring systems” or “iCGMs”) into Class II, meaning that going forward products of this generic type may utilize the 510(k) pathway.

Since then we have received 510(k) clearances for modifications to the G6 and approval for G7.

Since then we have received 510(k) clearances for modifications to the G6 and approval for G7 and G7 15 Day.

In 2024, the FDA cleared Stelo as an over-the-counter biosensor designed for adults with prediabetes and Type 2 diabetes who do not use insulin.

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Any delay in, or failure to receive or maintain, clearance or approval for our products could prevent us from generating revenue from these products.

The uncertain timing of regulatory approvals for future generations of our products could subject our current

inventory to excess or obsolescence charges, which could have an adverse effect on our business, financial condition and operating results.

The uncertain timing of regulatory approvals for future generations of our products could subject our current inventory to excess or obsolescence charges, which could have an adverse effect on our business, financial condition and operating results.

Our failure to comply with laws, regulations and contract requirements relating to reimbursement of health care goods and services may subject us to penalties and adversely impact our reputation, business, financial condition and cash flows.

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We train and educate employees and marketing representatives on the Anti-Kickback Statute and their obligations thereunder, and we endeavor to comply with the applicable safe harbors.

However, some of our arrangements, like many other common and non-abusive arrangements, may implicate the Anti-Kickback Statute and are not covered by a safe harbor, but nevertheless we do not believe them to present a significant risk to beneficiaries or federal healthcare programs and, as such, appear unlikely to invite government scrutiny or prosecution, warrant the imposition of sanctions, or be found to violate the statute.

However, some of our arrangements, like many other common and non-abusive arrangements, may implicate the Anti-Kickback Statute and are not covered

by a safe harbor, but nevertheless we do not believe them to present a significant risk to beneficiaries or federal healthcare programs and, as such, appear unlikely to invite government scrutiny or prosecution, warrant the imposition of sanctions, or be found to violate the statute.

However, we cannot offer assurance that the government or a whistleblower would agree with our position that certain arrangements fall within a safe harbor, or that arrangements that do not squarely meet an exception or safe harbor will not be found to violate the Anti-Kickback Statute.

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The revised Code also addresses value-based care arrangements.

We continue to assess industry responses to the Special Fraud Alert and have and may continue to make modifications to certain aspects of our speaker programs, which may have a detrimental impact on our ability to educate healthcare providers about our products and to promote use of our products, and which may in turn lead to decreased product sales and negatively impact our business, financial condition and results of operations.

Comprehensive healthcare legislation, signed into law in the United States in March 2010, titled the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, collectively, the ACA, imposes certain stringent compliance, recordkeeping, and reporting requirements on companies in various sectors of the life sciences industry, and enhanced penalties for non-compliance.

products and to promote use of our products, and which may in turn lead to decreased product sales and negatively impact our business, financial condition and results of operations.

The ACA imposes certain stringent compliance, recordkeeping, and reporting requirements on companies in various sectors of the life sciences industry, and enhanced penalties for non-compliance.

As 2025 ushers in a new presidential administration, we expect material changes in health policy, enforcement initiatives, and coverage and reimbursement for health care items and services.

With the presidential administration and as otherwise described in these Risk Factors, we expect material changes in health policy, enforcement initiatives, and coverage and reimbursement for health care items and services.

As such, our costs to monitor these changes and respond to new requirements will increase.

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Future significant changes in the healthcare systems in the United States or elsewhere could also have a negative impact on the demand for our current and future products.

These include changes that may reduce

reimbursement rates for our products and changes that may be proposed or implemented by the current or future laws or regulations.

These include changes that may reduce reimbursement rates for our products and changes that may be proposed or implemented by the current or future laws or regulations.

Risks Related to Intellectual Property Protection and Use

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If we are unable to successfully defend any such claims as they may arise or enter into or extend settlement and license agreements on acceptable terms or at all, our business operations may be harmed.

We have been involved in various patent infringement actions in the past.

For example, we and certain Abbott entities previously served complaints for patent infringement, validity, and other patent-related actions against each other in multiple jurisdictions, inside and outside the United States.

In December 2024, we entered into a Settlement and License Agreement with Abbott to settle all pending patent infringement legal proceedings brought by Abbott against us.

See “Legal Proceedings” in Part I, Item 3 below for more information.

We have been involved in various patent infringement actions in the past and in 2024, we entered into a settlement and license agreement with Abbott to settle all pending patent infringement legal proceedings brought by Abbott against us.

We granted Abbott and its affiliates, and Abbott and its affiliates granted us and our affiliates, a worldwide, royalty-free, non-exclusive, fully paid-up license to certain patents and patent applications relating to analyte sensing, including to all the patents asserted in the settled litigation.

As part of the agreement, each party, on behalf of itself and its affiliates, also entered into a covenant not to sue until December 20, 2034, and agreed on behalf of themselves and their affiliates to refrain from challenging the patents and patent applications licensed

under the settlement agreement for periods of time which vary depending on the relevant patents or patent applications.

Any infringement or misappropriation claim could cause us to incur significant costs, place significant strain on our financial resources, divert management’s attention from our business and harm our reputation.

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If we do not obtain any such necessary licenses, we may not be able to redesign our products to avoid infringement and any redesign may not receive FDA approval or other requisite marketing authorization in a timely manner or at all.

Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary intellectual property

licenses could prevent us from manufacturing and selling our products, which would have a significant adverse impact on our business.

Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary intellectual property licenses could prevent us from manufacturing and selling our products, which would have a significant adverse impact on our business.

If litigation were to be initiated by intellectual property owners, there could significant legal fees and costs incurred in defending litigation (which may include filing administrative actions to attack the intellectual property) as well as a potential monetary settlement payment to the owners, even if the matter is resolved before going to trial.

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To protect our proprietary rights, we may in the future need to assert claims of infringement against third parties.

The outcome of litigation to enforce our intellectual property rights in patents, copyrights, trade secrets or trademarks is highly unpredictable, could result in substantial costs and diversion of resources, and could have a material adverse effect on our business, financial condition and results of operations regardless of the final outcome of such litigation.

of such litigation.

In the event of an adverse judgment, a court could hold that some or all of our asserted intellectual property rights are not infringed, or are invalid or unenforceable, and could award attorney fees.

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This liability may vary based on the FDA classification associated with our devices.

Notably, the classification of our G6 and G7 systems as Class II medical devices is likely to weaken our ability to rely on federal preemption of state law claims that assert liability against us for harms arising from use of those systems.

Notably, the classification of our G6, G7 and G7 15 Day systems as Class II medical devices is likely to weaken our ability to rely on federal preemption of state law claims that assert liability against us for harms arising from use of those systems.

We may be subject to product liability claims if our products cause, or merely appear to have caused, an injury.

Claims may be made by customers, healthcare providers or others selling our products.

The risk of product liability claims may increase given that G6 and G7 do not require confirmatory finger sticks when making treatment decisions or finger stick tests each day for calibration, although it does require finger stick tests when symptoms do not match readings and when readings are unavailable.

The risk of product liability claims may increase given that G6, G7 and G7 15 Day do not require confirmatory finger sticks when making treatment decisions or finger stick tests each day for calibration, although it does require finger stick tests when symptoms do not match readings and when readings are unavailable.

The risk of claims may also increase if our products are subject to a product recall or seizure.

An example of the difficulty of complying with the regulatory requirements associated with the manufacture of our products, we issued notifications to our customers regarding the audible alarms and alerts associated with our receivers.

As an example of the difficulty of complying with the regulatory requirements associated with the manufacture of our products, we issued notifications to our customers regarding the audible alarms and alerts associated with our receivers.

Although we have insurance at levels that we believe is appropriate, this insurance is subject to deductibles and coverage limitations.

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If the FDA, FTC or other regulatory body with competent jurisdiction over us, our activities or products takes the position that our marketing, promotional or other materials or activities constitute improper promotion or marketing of an unapproved or improper use, or that they contain untruthful, misleading, or inadequately substantiated statements or claims, such regulatory body could request that we modify our materials or practices, or subject us to regulatory enforcement actions, including the issuance, depending on the regulatory body and the nature of the alleged violation, of a warning letter, injunction, seizure, civil fine and criminal penalties.

It is also possible that other federal, state or international enforcement authorities might take action if they consider promotional, marketing or other

materials or activities to constitute improper promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

It is also possible that other federal, state or international enforcement authorities might take action if they consider promotional, marketing or other materials or activities to constitute improper promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

Recent court decisions have impacted the FDA’s enforcement activity regarding off-label promotion in light of First Amendment considerations;

however, there are still significant risks in this area in part due to the potential False Claims Act exposure and the FDA’s continued focus on ensuring devices are marketed in a manner consistent with their FDA-required labeling.

We are not actively promoting our G6 or G7 systems for inpatient use, but if we supply them to such facilities in the future, this supply could present an increased risk of product liability claims and associated damages should an adverse event occur.

Given that the G6 and G7 systems have not yet been fully evaluated or tested (by us or by the FDA) to the extent that would be required in standard circumstances for product development and marketing authorization, there could be unknown or unanticipated risks presented by use in this environment.

We are not actively promoting our G6, G7 or G7 15 Day systems for inpatient use, but if we supply them to such facilities in the future, this supply could present an increased risk of product liability claims and associated damages should an adverse event occur.

Given that the G6, G7 and G7 15 Day systems have not yet been fully evaluated or tested (by us or by the FDA) to the extent that would be required in standard circumstances for product development and marketing authorization, there could be unknown or unanticipated risks presented by use in this environment.

In some instances in our advertising and promotion, we may make claims regarding our product as compared to competing products, which may subject us to heightened regulatory scrutiny, enforcement risk, and litigation risks.

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Our success will depend on our ability to attract and retain our personnel and manage our human capital, while controlling labor costs.

We depend to a significant degree on our senior management, especially Kevin Sayer, our President and Chief Executive Officer.

We depend to a significant degree on our senior management, especially Jake Leach, our President and Chief Executive Officer.

Our success will depend on our ability to retain our senior management and to attract and retain qualified personnel in the future, including salespersons, scientists, clinicians, engineers and other highly skilled personnel.

Competition for senior management personnel, as well as salespersons, scientists, clinicians and engineers, is intense and we may not be able to retain our personnel.

The loss of the services of members of our senior management, scientists, clinicians or engineers could prevent the implementation and completion of our

objectives, including the commercialization of our current products and the development and introduction of additional products.

The loss of the services of members of our senior management, scientists, clinicians or engineers could prevent the implementation and completion of our objectives, including the commercialization of our current products and the development and introduction of additional products.

The loss of a member of our senior management or our professional staff would require the remaining executive officers to divert immediate and substantial attention to seeking a replacement.

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We expect to continue to spend substantial amounts on commercialization of our products, including growth of our manufacturing capacity, on research and development, and conducting clinical trials for our future products.

Although we raised substantial net proceeds through the private sale of our convertible notes, we could need funds to continue the commercialization of our current products and to develop and commercialize future products or pursue other strategic initiatives.

Although we raised substantial net

proceeds through the private sale of our convertible notes, we could require funds to continue the commercialization of our current products and to develop and commercialize future products or pursue other strategic initiatives.

Additional financing may not be available on a timely basis on terms acceptable to us, or at all.

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For example, current economic conditions, including relatively high interest rates, inflation and potential economic slowdowns, as well as our business decisions, may reduce the value of some of our assets.

We also make investments in existing or new businesses, including investments in the international expansion of our sales efforts and the build-out of our manufacturing facility in Malaysia and the construction of a new facility in Ireland.

We also make investments in existing or new businesses,

including investments in the international expansion of our sales efforts and the build-out of our manufacturing facility in Malaysia and the construction of a new facility in Ireland.

Additionally, we also invest in early to late-stage companies for strategic reasons and to support key business initiatives, and we may not realize a return on our equity investments.

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Further, due to economic and political conditions, tax rates in various jurisdictions may be subject to change.

Our effective tax rates could be affected by numerous factors, including changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities, and changes in tax laws or their interpretation, both in and outside the United States, including as a result of the recent change in presidential administration in the United States.

There is growing pressure in many jurisdictions, including the United States, and from multinational organizations such as the OECD and the European Union to amend existing international tax rules in order to render them more responsive to current global business practices.

Our effective tax rates could be affected by numerous factors, including

changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities, and changes in tax laws or their interpretation, both in and outside the United States.

There is growing pressure in many jurisdictions, including the United States, and from multinational organizations such as the OECD and the EU to amend existing international tax rules in order to render them more responsive to current global business practices.

For example, the OECD has published a package of measures for reform of the international tax rules as a product of its BEPS initiative, which was endorsed by the G20 finance ministers.

Many of the initiatives in the BEPS package require amendments to the domestic tax legislation of various jurisdictions.

Separately, the European Union is asserting that a number of country-specific favorable tax regimes and rulings in certain member states may violate, or have violated, European Union law, and may require rebates of some or all of the associated tax benefits to be paid by benefited taxpayers in particular cases.

In 2016, the European Union adopted the “Anti-Tax Avoidance Directive,” which requires European Union member states to implement measures to prohibit tax avoidance practices, and Germany published the European Union Anti-Tax Avoidance Directive Implementation Law on June 30, 2021.

We have a significant presence in the European Union, as well as significant sales in the European Union, such that any changes in tax laws in the European Union could impact our business.

The overall impact of such legislation in European Union member states is uncertain, and our business and financial condition could be adversely affected by any laws impacting our tax rate.

government enacted comprehensive tax legislation that included significant changes to the taxation of business entities.

These changes included, among others, (I) a permanent reduction to the corporate income tax rate, (ii) a partial limitation on the deductibility of business interest expense, (iii) a shift of the U.S.

taxation of multinational corporations from a tax on worldwide income to a territorial system (along with certain rules designed to prevent erosion of the U.S.

income tax base) and (iv) a one-time tax on accumulated offshore earnings held in cash and illiquid assets, with the latter taxed at a lower rate.

On October 8, 2021, the OECD announced the OECD/G20 Inclusive Framework on BEPS which agreed to a two-pillar solution to address tax challenges arising from digitalization of the economy.

On December 20, 2021, the OECD released Pillar Two Model Rules defining the global minimum tax rules, which contemplate a 15% minimum tax rate.

The OECD continues to release additional guidance on these rules and the Framework calls for law enactment by OECD and G20 members to take effect in 2024 or 2025.

Separately, the EU is asserting that a number of country-specific favorable tax regimes and rulings in certain member states may violate, or have violated, EU law, and may require rebates of some or all of the associated tax benefits to be paid by benefited taxpayers in particular cases.

In 2016, the EU adopted the “Anti-Tax Avoidance Directive,” which requires EU member states to implement measures to prohibit tax avoidance practices.

We have a significant presence in the EU, as well as significant sales in the EU, such that any changes in tax laws in the EU could impact our business.

Our business and financial condition could be adversely affected by any laws impacting our tax rate.

In 2021, the OECD announced the OECD/G20 Inclusive Framework on BEPS which agreed to a two-pillar solution to address tax challenges arising from digitalization of the economy and released Pillar Two Model Rules defining the global minimum tax rules, which contemplate a 15% minimum tax rate.

Pillar Two became effective for tax years beginning on January 1, 2024 in many jurisdictions and the Undertaxed Profits Rule took effect on January 1, 2025 in most adopting countries.

These changes, when enacted by various countries in which we do business, may increase our taxes in these countries.

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We cannot guarantee the outcome of these examinations.

If our effective tax rates were to increase, particularly in the United States, or in other countries implementing legislation to reform existing tax legislation, including the European Union and Germany, or if the ultimate determination of our taxes owed is for an amount in excess of amounts previously accrued, our financial condition, operating results and cash flows could be adversely affected.

If our effective tax rates were to increase, particularly in the United States, or in other countries implementing legislation to reform existing tax legislation or if the ultimate determination of our taxes owed is for an amount in excess of amounts previously accrued, our financial condition, operating results and cash flows could be adversely affected.

Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability.

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There is also a risk that due to regulatory changes or changes to federal or state law, such as suspensions on the use of NOLs, or other unforeseen reasons, our existing NOLs could expire or otherwise be unavailable either in whole or in part to offset future income tax liabilities.

For example, under the Coronavirus Aid, Relief, and Economic Security Act of 2020, or CARES Act, which amended certain provisions of the Tax Cuts and Jobs Act of 2017, or TCJA, NOLs arising in taxable years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the five taxable years preceding the tax year of such loss, but NOLs arising in taxable years beginning after December 31, 2020 may not be carried back.

The TCJA, as amended by the CARES Act, also provides that NOLs from tax years that began after December 31, 2017 may offset no more than 80% of current taxable income annually for taxable years beginning after December 31, 2020.

Additionally, in June 2024, the State of California enacted S.B.

167, which suspends the use of NOLs for the tax period from January 1, 2024 to December 31, 2026 for net business income of $1.0 million or more, as well as limits the utilization of research and development tax credits to $5.0 million each year.

The State of California also passed S.B.

175 to provide for a potential early sunset of NOLs in either 2025 or 2026 if necessary.

See Note 7 “ Income Taxes ” to the consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K for additional information.

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Securities class action litigation has often been brought against public companies that experience periods of volatility in the market prices of their securities.

For example, we have pending securities class action litigation and a derivative action pending against us.

For example, we have pending securities class action litigation and derivative actions pending against us.

Securities class action litigation could result in substantial costs and a diversion of our management’s attention and resources, which could seriously harm our business.

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We currently intend to retain any future earnings to finance the operation and expansion of our business, and we do not expect to declare or pay any dividends in the foreseeable future and the terms of our credit agreement restrict our ability to declare or pay any dividends.

As a result, stockholders (including holders of our senior convertible notes who receive shares of our common stock, if any, upon conversion of their notes) may only receive a return on their investment in our common stock if the market price of our common stock increases.

As a result, stockholders (including holders of our senior convertible notes who receive shares of our

common stock, if any, upon conversion of their notes) may only receive a return on their investment in our common stock if the market price of our common stock increases.

Anti-takeover effects of our charter documents and Delaware law could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.

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Section 203 imposes certain restrictions on mergers, business combinations, and other transactions between us and holders of 15% or more of our common stock.

We cannot guarantee that the 2025 Share Repurchase Program will be fully consummated or that such program will enhance the long-term value of our share price.

In April 2025, our Board of Directors authorized and approved a share repurchase program of up to $750.0 million of our outstanding common stock, with a repurchase period ending no later than June 30, 2026, or the 2025 Share Repurchase Program.

Repurchases of our common stock under the 2025 Share Repurchase Program may be made from time to time in the open market, in privately negotiated transactions or by other methods, including through the use of trading plans intended to qualify under Rule 10b5-1 under the Exchange Act, at our discretion, and in accordance with the limitations set forth in Rule 10b-18 promulgated under the Exchange Act and other applicable federal and state laws and regulations.

The timing of any repurchases will depend on market conditions and will be made at our discretion.

The 2025 Share Repurchase Program does not obligate us to repurchase any dollar amount or number of shares of our common stock, and the program may be extended, modified, suspended, or discontinued at any time.

The 2025 Share Repurchase Program could affect the price of our common stock and increase the volatility thereof.

Price volatility may cause the average price at which we repurchase our common stock in a given period to exceed the stock’s price at a given point in time.

There can be no assurance that the timeframe for repurchases under our 2025 Share Repurchase Program or that any repurchases conducted thereunder will have a positive impact on our stock price or earnings per share.

Important factors that could cause us to discontinue or decrease share repurchases under the 2025 Share Repurchase Program include, among others, unfavorable market conditions;

the market price of our common stock;

the nature of other investment or strategic opportunities presented to us from time to time;

our ability to make appropriate, timely, and beneficial decisions as to when, how, and whether to repurchase shares under the 2025 Share Repurchase Program;

and the availability of funds necessary to fulfill such repurchases.

As of December 31, 2025, we have repurchased 7.7 million shares of our common stock for $500.0 million under the 2025 Share Repurchase Program.

Risks Related to Our Debt

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As of December 31, 2025, we were in compliance with the covenants imposed by the Amended Credit Agreement.

If we violate these or any other covenants, any outstanding amounts under the Amended Credit Agreement could become due and payable prior to their stated maturity dates, each lender could proceed against any collateral in our operating accounts and our ability to borrow funds in the future may be restricted or eliminated.

ability to borrow funds in the future may be restricted or eliminated.

These restrictions may also limit our ability to borrow additional funds and pursue other business opportunities or strategies that we would otherwise consider to be in our best interests.

We have indebtedness in the form of convertible senior notes, which could adversely affect our financial health and our ability to respond to changes in our business.

In May 2020, we completed an offering of approximately $1.21 billion aggregate principal amount of 0.25% senior convertible notes due 2025, or 2025 Notes, which offering we refer to as the 2020 Notes Offering.

In May 2023, we completed an offering of approximately $1.25 billion aggregate principal amount of 0.375% senior convertible notes due 2028, or 2028 Notes, which offering we refer to as the 2023 Notes Offering.

We refer to the 2020 Notes Offering and the 2023 Notes Offering, collectively, as the Notes Offerings, and we refer to the 2025 Notes and the 2028 Notes, collectively, as the Notes.

As a result of the Notes Offerings, we incurred $2.46 billion principal amount of indebtedness, the principal amount of which we may be required to pay at maturity.

Holders of the Notes will have the right to require us to repurchase their notes upon the occurrence of a fundamental change (as defined in the indenture for each of the Notes) at a purchase price equal to 100% of the principal amount of the notes to be purchased, plus accrued and unpaid interest, if any.

In addition, each indenture for the Notes provides that we are required to repay amounts due under each indenture in the event that there is an event of default for the Notes that results in the principal, premium, if any, and interest, if any, becoming due prior to the maturity date for the Notes.

In May 2023, we completed an offering of approximately $1.25 billion aggregate principal amount of 0.375% unsecured senior convertible notes due 2028, or the Notes or the 2028 Notes, which offering we refer to as the Notes Offering.

As a result of the Notes Offering, we incurred $1.25 billion principal amount of indebtedness, the principal amount of which we may be required to pay at maturity.

Holders of the Notes will have the right to require us to repurchase their notes upon the occurrence of a fundamental change (as defined in the indenture for the Notes) at a purchase price equal to 100% of the principal amount of the notes to be purchased, plus accrued and unpaid interest, if any.

In addition, the indenture for the Notes provides that we are required to repay amounts due under the indenture in the event that there is an event of default for the Notes that results in the principal, premium, if any, and interest, if any, becoming due prior to the maturity date for the Notes.

There can be no assurance that we will be able to repay this indebtedness when due, or that we will be able to refinance this indebtedness on acceptable terms or at all.

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Holders of the Notes will have the right to require us to repurchase their Notes upon the occurrence of a fundamental change at a purchase price equal to 100% of the principal amount of the Notes to be purchased, plus accrued and unpaid interest, if any, to, but not including, the fundamental change purchase date.

In addition, upon conversion of the Notes, unless we elect to deliver solely shares of our common stock to settle such conversion (other than cash in lieu of any fractional share), we will be required to make cash payments in respect of the Notes being converted.

However, we may not have enough available cash or be able to obtain financing at the time we are required to repurchase Notes surrendered upon a fundamental change or repay prior to maturity any accelerated amounts or pay cash for Notes being converted.

or by agreements governing our indebtedness outstanding at the time, including our Credit Facility.

In addition, our ability to purchase the Notes or repay prior to maturity any accelerated amounts under the Notes upon an event of default or pay cash upon conversions of the Notes may be limited by law, by regulatory authority or by agreements governing our indebtedness outstanding at the time, including our Credit Facility.

Under our Credit Facility, we are only permitted to use cash to purchase the Notes or repay prior to maturity any accelerated amounts under the Notes if we meet certain conditions that are defined under the Credit Agreement.

We may not meet these conditions in the future.

Our failure to repurchase Notes at a time when the repurchase is required by the respective indenture (whether upon a fundamental change or otherwise under each indenture) or pay cash payable on future conversions of the Notes as required by the indenture would constitute a default under each indenture.

A default under each indenture or the fundamental change itself could also lead to a default under agreements governing our existing or future indebtedness, including our Credit Facility.

Our failure to repurchase Notes at a time when the repurchase is required by the indenture (whether upon a fundamental change or otherwise under each indenture) or pay cash payable on future conversions of the Notes as required by the indenture would constitute a default under the indenture.

A default under the indenture or the fundamental change itself could also lead to a default under agreements governing our existing or future indebtedness, including our Credit Facility.

If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness, repurchase the Notes or make cash payments upon conversions thereof.

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We may incur substantial additional debt in the future, subject to the restrictions contained in our debt instruments, some of which may be secured debt.

We are not restricted under the terms of the indentures governing the Notes from incurring additional debt, securing existing or future debt, recapitalizing our debt, or taking a number of other actions that are not limited by the terms of the indenture governing the convertible senior notes that could have the effect of diminishing our ability to make payments on the Notes when due.

We are not restricted under the terms of the indenture governing the Notes from incurring additional debt, securing existing or future debt, recapitalizing our debt, or taking a number of other actions that are not limited by the terms of the indenture governing the convertible senior notes that could have the effect of diminishing our ability to make payments on the Notes when due.

The capped call transactions we entered into in connection with the pricing of the 2028 Notes may affect the value of our 2028 Notes and common stock.

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Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt.

Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness, including the Notes, depends on our future financial condition and operating performance, which is subject to

economic, financial, competitive and other factors beyond our control.

Our business may not continue to generate cash flow from operations in the future sufficient to satisfy our obligations under the Notes, our existing indebtedness and any future indebtedness we may incur and to make necessary capital expenditures.

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These alternative measures may not be successful and may not permit us to meet our scheduled debt servicing obligations.

Further, we may need to refinance all or a portion of our debt on or before maturity, and our ability to refinance the Notes, existing indebtedness or future indebtedness will depend on the capital markets and our financial condition at such time.

Further, we may need to refinance all or a portion of our debt on or before maturity, and our ability to refinance the Notes, existing indebtedness or future indebtedness

will depend on the capital markets and our financial condition at such time.

We may not be able to engage in any of these activities on commercially reasonable terms or at all, which could result in a default on the Notes or our current and future indebtedness.

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In addition, our Amended Credit Agreement and the agreements governing the Notes each contain cross-default provisions whereby a default under one agreement would likely result in cross defaults under agreements covering other borrowings.

For example, the occurrence of a default with respect to any indebtedness or any failure to repay debt when due in an amount in excess of $50.0 million, in the case of the 2025 Notes, and $50.0 million, in the case of the 2028 Notes, that causes such indebtedness to become due prior to its scheduled maturity date would cause a cross-default under the indenture governing the Notes.

For example, the occurrence of a default with respect to any indebtedness or any failure to repay debt when due in an amount in excess of $50.0 million that causes such indebtedness to become due prior to its scheduled maturity date would cause a cross-default under the indenture governing the Notes.

In addition, the occurrence of a default with respect to any indebtedness or any failure to repay debt when due in an amount in excess of $25.0 million that causes such indebtedness to become due prior to its scheduled maturity date would cause a default under our Amended Credit Agreement.

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If the conditional conversion feature of the Notes is triggered, holders of the Notes will be entitled to convert the Notes at any time during specified periods at their option.

If one or more holders elect to convert their Notes, unless

we elect to satisfy our conversion obligation by delivering solely shares of our common stock (other than by paying cash in lieu of delivering any fractional share), we may settle all or a portion of our conversion obligation in cash, which could adversely affect our liquidity.

If one or more holders elect to convert their Notes, unless we elect to satisfy our conversion obligation by delivering solely shares of our common stock (other than by paying cash in lieu of delivering any fractional share), we may settle all or a portion of our conversion obligation in cash, which could adversely affect our liquidity.

In addition, the consideration received upon the unwind or termination of the capped call transactions may not completely offset, and may be substantially less than, any cash payments in excess of the principal amount of the Notes we are required to make upon conversion of the Notes.

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Collecting, measuring and reporting sustainability-related data and information is subject to evolving reporting standards, including state climate-related reporting requirements, the EU’s environmental, social and governance-related disclosure requirements set forth in the Corporate Sustainability Reporting Directive, and similar proposals by other international regulatory bodies.

We will also be subject to reporting requirements in California covering disclosure of greenhouse gas emissions data, climate-related financial risks, and details around emissions-related claims and carbon offsets.

We are also subject to reporting requirements in California covering disclosure of greenhouse gas emissions data, climate-related financial risks and opportunities, and details around emissions-related claims and carbon offsets, if applicable.

If our sustainability-related data, information, processes or reporting are incomplete or inaccurate, it could result in adverse regulatory consequences and/or our reputation, business, financial performance and growth could be adversely affected.

Further, a number of governments are considering due diligence procedures to ensure strict compliance with environmental, labor, and government regulations.

For example, the European Union has recently proposed broad due diligence reporting requirements for all industries operating within Europe.

For example, the EU has proposed broad due diligence reporting requirements for all industries operating within Europe.

In addition, a number of our upstream and downstream stakeholders in our value chain have adopted, or may adopt, procurement policies that include sustainability provisions that their business partners must comply with, or they may seek to include such provisions in their terms and conditions.

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Our business could be negatively impacted by evolving expectations and challenges relating to implementing sustainability (including environmental, social and governance) initiatives, setting sustainability-related goals, collecting sustainability-related data, and disclosing sustainability-related information.

We may communicate certain initiatives and, in the future, may communicate goals regarding sustainability-related matters (including environmental, social and governance) in our SEC filings or in other public disclosures.

These sustainability-related initiatives and goals could be difficult and expensive to implement, the technologies needed to implement them may not be cost effective and may not advance at a sufficient pace, and we could be criticized for

the accuracy, adequacy or completeness of the disclosure.

Further, statements about our sustainability-related initiatives and any future sustainability-related goals, and progress against any future sustainability-related goals, may be based on standards for measuring progress that are still developing, internal controls and processes that continue to evolve, and assumptions that are subject to change and audit in the future based on evolving standards, frameworks, and regulations.

We may communicate certain initiatives and may communicate goals regarding sustainability-related matters (including environmental, social and governance) in our SEC filings or in other public disclosures.

Further, statements about our sustainability-related initiatives and any sustainability-related goals, and progress against future sustainability-related goals, may be based on standards for measuring progress that are still developing, internal controls and processes that continue to evolve, and assumptions that are subject to change and audit in the future based on evolving standards, frameworks, and regulations.

In addition, we could be criticized for the scope or nature of such initiatives or goals, or for any revisions to these goals.

If our sustainability-related data, processes and reporting are incomplete or inaccurate, or if we fail to achieve progress with respect to any future sustainability-related goals on a timely basis, or at all, we could experience adverse regulatory consequences and/or our reputation, business, financial performance and growth could be adversely affected.

Climate change may have a long-term impact on our business.

If our sustainability-related data, processes and reporting are incomplete or inaccurate, or if we fail to achieve progress with respect to any sustainability-related goals on a timely basis, or at

all, we could experience adverse regulatory consequences and/or our reputation, business, financial performance and growth could be adversely affected.

Climate change may have an adverse impact on our business.

While we seek to partner with organizations that mitigate their business risks associated with climate change, we recognize that there are inherent risks related to climate change wherever business is conducted.

Ensuring business resiliency through mitigating risks related to climate change in the communities where we conduct our business is a priority, whether for our offices or for our stakeholders.

Our manufacturing sites in California, Arizona and Malaysia and our operations in the Philippines are vulnerable to climate change effects.

Ensuring business resiliency through mitigating climate-related risks in the communities where we conduct our business is a priority, whether for our offices or for our stakeholders.

Our manufacturing sites in Ireland, Arizona and Malaysia and our global operations, including California and the Philippines, are vulnerable to climate change effects.

For example, in California and Arizona, increasing intensity of droughts throughout the states and annual periods of wildfire danger increase the probability of planned and unplanned power outages in the communities where we work and live.

While this danger has a low-assessed risk of disrupting normal business operations, it has the potential impact on employees’ abilities to commute to work or to work from home and stay connected effectively.

Climate-related events, including the increasing frequency of extreme weather events and their impact on the U.S., the Philippines, Malaysia and other major regions’ critical infrastructure, have the potential to disrupt our business, our third-party suppliers, and/or the business of our customers, and may cause us to experience higher attrition, losses, and additional costs to maintain or resume operations.

Climate-related events, including the increasing frequency of extreme weather events and their impact on the U.S., the Philippines, Malaysia, Ireland and other major regions’ critical infrastructure, have the potential to disrupt our business, our third-party suppliers, and/or the business of our customers, and may cause us to experience higher attrition, losses, and additional costs to maintain or resume operations.

We may be liable for contamination or other harm caused by materials that we handle, and changes in environmental regulations could cause us to incur additional expense.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors