9 unchanged sentences
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.
−Removed: 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, increased market power of payors, and increased competition among suppliers, including manufacturing services providers, as the medical device industry consolidates.
−Removed: If the prices for our products and services decrease and we are unable to reduce our expenses, including the cost of sourcing materials, logistics and the cost to manufacture our products, our business, results of operations, financial condition and cash flows will be adversely affected.
−Removed: We are subject to cost-containment efforts by third-party payors that could result in reduced product pricing and/or sales of our products and cause a reduction in revenue.
+Added: 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.
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.
−Removed: Most of our customers rely on third-party payors, including government programs and private health insurance plans, to cover the cost of our products.
−Removed: We expect that these continuing cost reduction and containment measures may reduce the cost or utilization of our products and could lead to patients being unable to obtain approval for coverage or payment from these third-party payors or to costs being shifted to patients for our products.
−Removed: Additionally, as a result of the economic slowdown, some customers have lost access and others may lose access to their private health insurance plan if they lose their job, and an impact to job status may extend for a prolonged period of time, beyond possible coverage periods through COBRA, or where the cost to maintain coverage may not be affordable to our customers.
−Removed: As most of our customers currently rely on third-party payors, including government programs and private health insurance plans, to cover the cost of our products, our customers may lose coverage or reimbursement for our products, which may harm our business and results of operations.
−Removed: We have experienced, and anticipate that we will continue to experience, downward pressure on product pricing.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: If the prices for our products decrease and/or if we are unable to offset the effects of general inflation on our operating costs through increases in the prices for our products, our business, results of operations, financial condition and cash flows will be adversely affected.
Although many third-party payors have adopted some form of coverage policy for continuous glucose monitoring devices, our products do not always have such coverage, including simple broad-based contractual coverage with third-party payors, and we frequently experience administrative challenges in obtaining coverage or reimbursement for our products.
3 unchanged sentences
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.
−Removed: Therefore, Medicare reimbursement for our CGM devices is subject to various coverage conditions
−Removed: and often requires a patient-specific coverage analysis.
+Added: 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.
5 unchanged sentences
Adverse coverage or reimbursement decisions relating to our products, or rescission or limitation of favorable determinations, by CMS, its Medicare Administrative Contractors, other state, federal or international payors, and/or third-party commercial payors could significantly reduce reimbursement, which could have an impact on the acceptance of, and demand for, our products and the prices that our customers are willing to pay for them.
−Removed: As of December 31, 2023, the eight largest private third-party payors, in terms of the number of covered lives, have issued coverage policies for the category of CGM devices.
−Removed: In addition, we have negotiated contracted rates with all of those third-party payors for the purchase of our current CGM systems by their members.
+Added: As of December 31, 2024, the eight largest private third-party payors in the United States, in terms of the number of covered lives, have issued coverage policies for the category of CGM devices.
+Added: In addition, we have negotiated contracted rates with all of those third-party payors for the purchase of the G6 and G7 systems by their members.
Nevertheless, coverage and reimbursement-related barriers remain.
Among other things, people with diabetes without insurance that covers our products bear the entire financial cost of using our products.
−Removed: In addition, in the United States, people with diabetes using existing single-point finger stick devices are generally reimbursed all or part of the product cost by Medicare or other third-party payors, which may be perceived as more advantageous for consumers.
−Removed: 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 for policy holders to obtain reimbursement, and as a result, we have difficulty improving the efficiency of our customer service group.
+Added: 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.
+Added: 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.
Moreover, it is not uncommon for governmental, including federal and/or state, agencies and their contractors to conduct periodic routine billing and compliance reviews that may entail extensive documentation requests, cooperation with which may require significant time and resources, and may result in identification of overpayments that may need to be refunded.
8 unchanged sentences
In December 2021, CMS published a final rule expanding the classification of DME under Medicare Parts B & C to include adjunctive CGMs (i.e., CGMs that do not replace standard blood glucose monitors for treatment decisions) and related supplies.
−Removed: This final rule expands coverage of CGMs to include a large competitor’s competing device, which may negatively impact our sales.
+Added: 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.
+Added: In addition, 2025 will bring a new presidential administration, which may shift health policy priorities, including potential impacts on Medicare coverage and reimbursement.
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.
1 unchanged sentence
Accordingly, unless government and other third-party payors provide adequate coverage and reimbursement for our current CGM systems or any future products we may develop, people without coverage who have diabetes may not use our products.
−Removed: 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
−Removed: 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.
−Removed: Also, the trends toward managed healthcare in the United States 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.
−Removed: In many foreign markets, pricing and profitability of medical devices are subject to government control.
+Added: 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.
+Added: 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
+Added: 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.
+Added: In many international markets, pricing and profitability of medical devices are subject to government control.
We are susceptible to changes in government-mandated coverage requirements and other controls which could impact access to and affordability of our products.
−Removed: In the United States, we expect that there will continue to be federal and state proposals for similar controls.
+Added: In the United States, federal and state proposals for similar controls may continue and/or increase.
As we continue to expand internationally, these government controls will have an increasing effect on our business and results of operations.
3 unchanged sentences
In order to address the anticipated needs of our customers, pursue new markets for our existing products and any new products, and to remain competitive, we focus our research and development efforts and strategic third-party collaboration activities on the enhancement of our current CGM products, the development of next-generation products and the development of novel technologies and services.
−Removed: The development of new products, or novel technologies and services and the enhancement of our current CGM products (including seeking and potentially obtaining new indications for use), requires significant investment in research and development, intellectual property protection, clinical trials, regulatory approvals and in obtaining third party reimbursement.
+Added: The development of new products, or novel technologies and services and the enhancement of our current CGM products (including seeking and potentially obtaining new indications for use), is difficult, expensive and time-consuming and requires significant investment in research and development, intellectual property protection, clinical trials, regulatory approvals and in obtaining third party reimbursement.
The results of our product development and commercialization efforts may be affected by a range of factors, including our ability to anticipate customer needs, innovate and develop new products (whether independently or with our partners), determine a feasible or timely regulatory pathway or approach, and launch those products cost effectively into multiple markets and geographies.
4 unchanged sentences
Even if our development and clinical trial efforts appear successful to us and our regulatory submission appears satisfactory to us, the FDA or comparable international regulator may disagree and may decide not to grant marketing authorization for the products or may require additional product testing or clinical trials or other data to be developed and submitted before approving the products, which would result in product launch delays and additional expense.
−Removed: 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 and people with diabetes.
+Added: 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.
1 unchanged sentence
As a result of these relationships, our operating results depend, to some extent, on the ability of our partners to successfully commercialize their insulin delivery systems or monitoring products.
−Removed: Any factors that may limit our partners’ ability to achieve widespread adoption of their systems, including competitive pressures, technological breakthroughs for the treatment or prevention of diabetes, adverse regulatory or legal actions relating to insulin pump products, or
−Removed: changes in reimbursement rates or policies of third-party payors relating to insulin pumps or similar products, could have an adverse impact on our operating results.
+Added: Any factors that may limit our partners’ ability to achieve widespread adoption of their systems, including competitive pressures, technological breakthroughs for the treatment or prevention of diabetes, adverse regulatory or legal actions relating to insulin pump products, or changes in reimbursement rates or policies of third-party payors relating to insulin pumps or similar products, could have an adverse impact on our operating results.
Many of the companies that we collaborate with are also competitors or potential competitors who may decide to terminate our collaborative arrangement.
−Removed: 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.
+Added: In the event of such a termination, we may be required to devote
+Added: 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.
7 unchanged sentences
• 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;
−Removed: • widespread market acceptance of our products by health care professionals and people with diabetes will largely depend on our ability to demonstrate their relative safety, effectiveness, reliability, cost-effectiveness and ease of use;
+Added: • 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;
• the limited size of our sales force;
12 unchanged sentences
• rapid technological change may make our technology and our products obsolete.
−Removed: In addition to the risks outlined above, our G6 and G7 systems are more invasive than many other self-monitored glucose testing systems, including single-point finger stick devices, and people with diabetes may be unwilling to insert a sensor in their body, especially if their current diabetes management involves no more than two finger sticks per day.
−Removed: Moreover, people with diabetes may not perceive the benefits of CGM and may be unwilling to change their current treatment regimens.
−Removed: 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, and (iii) reimbursement or insurance coverage is more widely available.
−Removed: In addition, market acceptance of our products by physicians and people with diabetes in Europe or other countries will largely depend on our ability to demonstrate their relative safety, effectiveness, reliability, cost-effectiveness and ease of use.
−Removed: If we are unable to do so, we may not be able to generate product revenue from our sales efforts in Europe or other countries.
−Removed: We cannot predict when, if ever, healthcare professionals, including physicians, and people with diabetes may adopt more widespread use of CGM systems, including our systems.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: If we are unable to do so, we may not be able to generate product revenue from our international sales efforts.
+Added: 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.
We are also aware of the increasing use of GLP-1 products for the treatment of obesity and Type 2 diabetes.
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.
−Removed: If our CGM systems do not achieve and maintain an adequate level of acceptance by people with diabetes, healthcare professionals, including physicians, and third party payors, our future revenue may be reduced and our business may be harmed.
+Added: 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
2 unchanged sentences
In the past, we have had difficulty scaling our manufacturing operations to provide a sufficient supply of product to support market demand and our commercialization efforts.
−Removed: From time to time, we have also experienced brief periods of backorder and, at times, have had to limit the efforts of our sales force to introduce our products to new customers.
−Removed: We have focused significant effort on continual improvement programs in our manufacturing operations intended to improve quality, yields and throughput.
−Removed: We have made progress in manufacturing to enable us to supply adequate amounts of product to support our commercialization efforts;
−Removed: however, we cannot guarantee that supply will not be constrained in the future.
−Removed: We may not adequately predict the market demand for our products, in order to produce our products in the quantities we anticipate will be necessary to meet market demand.
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: and other countries.
+Added: While we are currently working to remedy such challenges, we cannot predict when such manufacturing and inventory challenges will be remedied.
+Added: 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.
+Added: This could lead to loss of sales of and revenues from our products, could potentially decrease our market share, and/or our business, financial condition, results of operations and growth prospects could be materially adversely affected.
+Added: 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.
+Added: 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.
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.
−Removed: We are also expanding our facility in Mesa, Arizona, and plan to begin construction of a new facility in Ireland to scale up manufacturing capacity.
+Added: We also commenced construction of 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.
1 unchanged sentence
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.
−Removed: The scaling of 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.
+Added: 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,
+Added: 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.
−Removed: Our facilities are subject to inspections by the FDA and corresponding state and international agencies on an ongoing basis, and we must comply with Good Manufacturing Practices and the FDA Quality System Regulation, as well as certain state
−Removed: requirements.
−Removed: We may be unable to adequately maintain, develop and expand our manufacturing process and operations or maintain compliance with FDA and state and international agency requirements, and manufacturing issues could impact our cleared and approved products.
−Removed: If we are unable to manufacture a sufficient supply of our current products or any future products for which we may receive approval or clearance, maintain control over expenses or otherwise adapt to anticipated growth, or if we underestimate growth, we may not have the capability to satisfy market demand, contractual obligations, and our business will suffer.
+Added: Our facilities are subject to inspections by the FDA and corresponding state and international agencies on an ongoing basis, and we must comply with Good Manufacturing Practices and the FDA Quality System Regulation, as well as certain state and local requirements.
+Added: We may be unable to adequately maintain, develop and expand our manufacturing process and operations or maintain compliance with FDA and state and international agency requirements.
+Added: If we are unable to manufacture a sufficient supply of our current products or any future products for which we may receive approval or clearance, maintain control over expenses or otherwise adapt to anticipated growth, or if we underestimate growth, we may not have the capability to satisfy market demand or our contractual obligations, and our business will suffer.
Manufacturing difficulties and/or any disruption at our facilities may adversely affect our manufacturing operations and related product sales, and increase our expenses.
−Removed: Our products are manufactured at certain facilities, with limited alternate facilities.
+Added: Our products require multiple manufacturing processes and steps.
+Added: 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.
+Added: 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.
+Added: and other countries.
+Added: In addition, our products are manufactured at certain facilities, with limited alternate facilities.
If an event occurs at one of our facilities that results in damage to, restrictions on the use of, or closure of, one or more of such facilities, or if our distributions from those facilities are limited or restricted in any way, we may be unable to manufacture the relevant products at the previous levels or at all.
4 unchanged sentences
Earthquakes are of particular significance since our manufacturing facilities in California are located in an earthquake-prone area.
−Removed: Wildfires are also increasingly more common in southern California and present risk to our manufacturing operations.
+Added: Wildfires are also increasingly common in southern California and present risk to our manufacturing operations.
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.
2 unchanged sentences
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.
−Removed: 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, and our business could be harmed.
+Added: 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.
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.
3 unchanged sentences
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.
−Removed: In some cases, our agreements with these and other suppliers can be terminated by either party upon short notice.
+Added: In some cases, our agreements with these and other suppliers can be terminated by
+Added: 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.
2 unchanged sentences
They may fail to follow specific protocols and procedures, fail to comply with applicable regulations, or be the subject of FDA or other regulatory authority audits or inspections that result in allegations of non-compliance (for example, resulting in Form 483 Observations, Warning Letters, or other FDA enforcement actions).
−Removed: Our manufacturers and suppliers may also experience or be impacted by equipment malfunction, environmental factors, and public health emergencies, any of which could delay or impede their ability to meet our demand.
+Added: Our manufacturers and suppliers may also experience or be impacted by equipment malfunction, environmental factors, cyber-attacks and public health emergencies, any of which could delay or impede their ability to meet our demand.
Further, if our sole- or single-source suppliers shift their manufacturing and assembly sites to other locations, depending on the circumstances and nature of the item supplied, in addition to quality system activities such as verification and validation, there could be a need for FDA or international regulator notifications or submissions, and the new locations could be subject to regulatory inspections.
−Removed: If there are regulatory delays or impediments impacting
−Removed: our suppliers or us for any reason, we may not be able to quickly establish additional or replacement suppliers, particularly for our single-source components, in part because of the custom nature of various parts we design.
+Added: If there are regulatory delays or impediments impacting our suppliers or us for any reason, we may not be able to quickly establish additional or replacement suppliers, particularly for our single-source components, in part because of the custom nature of various parts we design.
Any interruption or delay in the supply of components or materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders or switch to competitive products.
13 unchanged sentences
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.
−Removed: If we are unable to establish and maintain adequate sales, marketing and distribution capabilities 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.
−Removed: We must continue to develop and grow our sales and marketing organization and enter into partnerships or other arrangements to market and sell our products and/or collaborate with third parties, including distributors and others, to market and sell our products to maintain the commercial success of our current systems and to achieve commercial success for any of our future products.
−Removed: If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, independently or with others, our future revenue may be reduced and our business may be harmed.
+Added: 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.
+Added: We must continue to develop and grow our sales and marketing organization and/or enter into partnerships or other arrangements to market and sell our products and/or collaborate with third parties, including distributors and others, to market and sell our products to maintain the commercial success of our current products and to achieve commercial success for any of our future products.
+Added: In 2024, we launched Stelo in the United States and are expanding distribution capabilities for its sales.
+Added: If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, independently or with others, for our products, our future revenue may be reduced and our business may be harmed.
Developing and managing a direct sales organization is a difficult, expensive and time-consuming process.
4 unchanged sentences
• manage geographically dispersed sales and marketing operations;
−Removed: • effectively train our sales and marketing personnel on the applicable advertising and promotion, and fraud and abuse laws that govern interactions with healthcare professionals and institutions as well as current and prospective patients and maintain active oversight and auditing measures to ensure continued compliance.
−Removed: We currently employ sales and marketing personnel for the direct sale and marketing of our products in North America, Asia Pacific, Europe and the Middle East.
+Added: • effectively train our sales and marketing personnel on the applicable advertising and promotion, and fraud and abuse laws that govern interactions with healthcare professionals and institutions as well as current and prospective patients and customers and maintain active oversight and auditing measures to ensure continued compliance.
+Added: We currently employ sales and marketing personnel for the direct sale and marketing of certain of our products in North America, Asia Pacific, Europe and the Middle East.
Our direct sales and marketing team calls on healthcare providers and people with diabetes throughout the applicable country, to the extent permissible, to raise awareness and initiate sales of our products.
9 unchanged sentences
A substantial decrease or loss of these sales could have a material adverse effect on our financial results and operating performance.
−Removed: We have entered into arrangements with pharmacy organizations in various countries to dispense our products directly to patients.
+Added: We have also entered into arrangements with pharmacy organizations in various countries to dispense our products directly to patients.
Because of the competition for their services, we may be unable to enter into new partnerships or otherwise expand our pharmacy network on commercially reasonable terms, if at all.
9 unchanged sentences
Therefore, our products may be rendered obsolete by technological breakthroughs in diabetes monitoring, treatment, prevention or cure.
−Removed: In selling our current CGM systems, we compete directly with the Diabetes Care division of Abbott Laboratories;
+Added: In selling our G6, G7 and Dexcom One, we compete directly with the Diabetes Care division of Abbott Laboratories;
Medtronic plc’s Diabetes Group;
1 unchanged sentence
privately-held LifeScan, Inc.;
−Removed: and Ascensia Diabetes Care, each of which manufactures and markets products for the single-point finger stick
−Removed: device market.
−Removed: Collectively, these companies currently account for the majority of the worldwide sales of self-monitored glucose testing systems.
+Added: and Ascensia Diabetes Care, each of which manufactures and markets products for the single-point finger stick device market.
+Added: In selling Stelo, we compete directly with the Diabetes Care division of Abbott Laboratories.
+Added: Collectively with us, these companies currently account for the majority of the worldwide sales of self-monitored glucose testing systems.
+Added: We are also aware of emerging competitors primarily located in China.
Our competitors manufacturing adjunctive CGMs have also recognized expanded Medicare coverage of their CGM devices and supplies following CMS’ December 2021 final rule expanding the classification of DME under Medicare Parts B & C to include adjunctive CGMs.
19 unchanged sentences
We are subject to risks associated with public health issues, including pandemics, which could have a material adverse effect on our business, financial condition and results of operations.
−Removed: We are subject to risks associated with public health issues, such as the recent COVID-19 pandemic, and other events beyond our control.
+Added: We are subject to risks associated with public health issues, such as the previous COVID-19 pandemic, and other events beyond our control.
Public health issues and crises may adversely impact our operations, supply chain and logistics network if the locations where we operate, manufacture or distribute our products;
12 unchanged sentences
For example, in 2023, we completed the initial phase of construction of our new facility in Malaysia and commenced commercial manufacturing.
−Removed: We also and plan to begin construction of a new facility in Ireland.
−Removed: Our international expansion efforts, including our new manufacturing facilities in Malaysia and proposed facility in Ireland, may not be successful and we may experience difficulties in scaling these functions from locations outside the United States and may not experience the expected cost efficiencies.
+Added: We also are building a new manufacturing facility in Ireland.
+Added: Our international expansion efforts, including our new manufacturing facilities in Malaysia and facility under construction in Ireland, may not be successful and we may experience difficulties in scaling these functions from locations outside the United States and may not experience the expected cost efficiencies.
Our profitability and international operations are, and will continue to be, subject to a number of risks and potential costs, including:
5 unchanged sentences
• workforce instability;
−Removed: • fluctuations in trade policy and tariff regulations;
+Added: • fluctuations in trade policy and tariff regulations, including potential higher tariffs on imported goods and materials and renegotiation of free trade agreements and potential retaliatory tariffs imposed by foreign countries against U.S.
• political and economic instability.
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.
−Removed: 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 will impact our business.
+Added: 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.
20 unchanged sentences
Department of Commerce, administer certain laws and regulations that restrict U.S.
−Removed: persons and, in some
−Removed: instances, non-U.S.
+Added: persons and, in some instances, non-U.S.
persons, in conducting activities, and transacting business with or making investments in certain countries, governments, entities and individuals subject to U.S.
14 unchanged sentences
Global enforcement of anti-corruption laws has increased substantially in recent years, with more frequent voluntary self-disclosures by companies, aggressive investigations and enforcement proceedings by U.S.
−Removed: and foreign governmental agencies, and assessment of significant fines and penalties against companies and individuals.
+Added: and international governmental agencies, and assessment of significant fines and penalties against companies and individuals.
Our international operations create the risk of unauthorized payments or offers of payments by one of our employees, consultants, sales agents, or distributors, because these parties are not always subject to our direct oversight and control.
2 unchanged sentences
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.
−Removed: 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.
+Added: 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
+Added: 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.
1 unchanged sentence
These conditions have been adversely impacted by continued global economic uncertainty, political instability and military hostilities in multiple geographies, concerns over continued sovereign debt, potential recessions, a potential U.S.
−Removed: federal government shutdown, monetary and financial uncertainties in Europe and other foreign countries, and global health pandemics.
+Added: federal government shutdown, monetary and financial uncertainties in Europe and other international jurisdictions, and global health pandemics.
These include potential reductions in the overall stability and suitability of the Euro as a single currency, given the economic and political challenges facing individual Eurozone countries.
6 unchanged sentences
These and other economic factors could have a material adverse effect on our business, financial condition and results of operations.
−Removed: Failure to obtain any required regulatory authorization in foreign jurisdictions will prevent us from marketing our products abroad.
+Added: Failure to obtain any required regulatory authorization in international jurisdictions will prevent us from marketing our products abroad.
We conduct limited commercial and marketing efforts in certain international markets in the Asia-Pacific, North America and Europe, Middle East and Africa regions, with respect to our CGM systems and may seek to market our products in other regions in the future.
1 unchanged sentence
The marketing authorization procedures vary among countries and can involve additional testing, and the time required to obtain any required authorization or approval may differ from that required to obtain FDA marketing authorization(s).
−Removed: Foreign regulatory authorization or approval processes may include all of the risks associated with obtaining FDA marketing authorization(s) in addition to other risks.
−Removed: We may not obtain foreign regulatory authorizations or approvals on a timely basis, if at all.
−Removed: 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 foreign regulatory authority does not ensure authorization or approval by regulatory authorities in other foreign countries or by the FDA.
−Removed: In addition, in order to obtain the authorization to market our products in certain foreign jurisdictions, in some cases we may need to obtain a Certificate to Foreign Government from the FDA.
+Added: International regulatory authorization or approval processes may include all of the risks associated with obtaining FDA marketing authorization(s) in addition to other risks.
+Added: We may not obtain international regulatory authorizations or approvals on a timely basis, if at all.
+Added: 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.
+Added: 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.
The FDA may refuse to issue a Certificate to Foreign Government if significant compliance-related concerns are identified.
2 unchanged sentences
We are subject to complex and evolving U.S.
−Removed: and foreign laws and regulations and other requirements regarding privacy, data protection, security, and other matters.
+Added: and international laws and regulations and other requirements regarding privacy, data protection, security, and other matters.
Many of these laws and regulations are subject to change and uncertain interpretation, and could result in claims, changes to our business practices, monetary penalties, increased cost of operations, or declines in user growth or engagement, or otherwise harm our business.
−Removed: We are subject to a number of foreign, 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.
−Removed: 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, and the California Consumer Privacy Act as amended, or CCPA, and the Washington My Health My Data Act, among others.
+Added: 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.
+Added: 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.
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.
1 unchanged sentence
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.
−Removed: Such AG investigations—which are often time consuming, expensive, and burdensome—may 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.
+Added: 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.
Class action lawsuits against companies which experience a data breach involving personal information are also common.
Additionally, the SEC and many jurisdictions have enacted or may enact laws and regulations requiring companies to disclose or otherwise provide notifications regarding data security breaches.
−Removed: For example, the SEC recently adopted cybersecurity risk management and disclosure rules, which require the disclosure of information pertaining to cybersecurity incidents and cybersecurity risk management, strategy, and governance.
+Added: For example, the SEC has adopted cybersecurity risk management and disclosure rules, which require the disclosure of information pertaining to cybersecurity incidents and cybersecurity risk management, strategy, and governance.
As our customer base grows to include U.S.
−Removed: federal government agencies, Dexcom may also need comply with Federal Risk and Authorization Management Program and Cybersecurity Maturity Model Certification requirements.
+Added: federal government agencies, we may also need comply with Federal Risk and Authorization Management Program and Cybersecurity Maturity Model Certification requirements.
These frameworks, in addition to similar laws being enacted by other states and other jurisdictions, impose stringent cybersecurity standards and potentially significant non-compliance penalties, and involve the expenditure of significant resources and time and effort to comply.
−Removed: As these laws and regulations continue develop in the United States and internationally, we may be required to expend significant time and resources in order to update existing processes or implement additional mechanisms as necessary to ensure compliance with such laws.
−Removed: In addition, foreign data protection, privacy, and other laws and regulations can be more restrictive than those in the United States.
+Added: As these laws and regulations continue to develop in the United States and internationally, we may be required to expend significant time and resources in order to update existing processes or implement additional mechanisms as necessary to ensure compliance with such laws.
+Added: In addition, international data protection, privacy, and other laws and regulations can be more restrictive than those in the United States.
For example, data localization laws in some countries generally mandate that certain types of data collected in a particular country be stored and/or processed within that country.
−Removed: We may be subject to inquiries, investigations and audits in Europe and around the world, particularly in the areas of consumer and data protection,
−Removed: which will arise in the ordinary course of business and may increase in frequency as we continue to grow and expand our operations.
+Added: We may be subject to inquiries, investigations and audits in Europe and around the world, particularly in the areas of consumer and data protection, which will arise in the ordinary course of business and may increase in frequency as we continue to grow and expand our operations.
Legislators and regulators may make legal and regulatory changes, or interpret and apply existing laws, in ways that make our products less useful to our customers, require us to incur substantial costs, expose us to unanticipated civil or criminal liability, or cause us to change our business practices.
5 unchanged sentences
Any such occurrence could compromise our networks and the information stored thereon could be accessed, publicly disclosed, lost or stolen.
−Removed: Any such access, disclosure or other loss of information could result in legal claims or proceedings, and liability under laws that protect the privacy of personal information, including regulatory penalties, disrupt our operations and the services we provide to our clients or damage our reputation, any of which could adversely affect our profitability, revenue and competitive position.
−Removed: As we grow and expand our administrative, customer, or IT support services, we may also utilize the services of personnel and contractors located outside of the United States to perform certain functions.
+Added: Any such access, acquisition, disclosure or other loss of information could result in legal claims or proceedings, and liability under laws that protect the privacy of personal information, including regulatory penalties, disrupt our operations and the services we provide to our clients or damage our reputation, any of which could adversely affect our profitability, revenue and competitive position.
+Added: As we grow and expand our administrative, customer, or IT support services, we also utilize the services of personnel and contractors located outside of the United States to perform certain functions.
While we make every effort to review our applicable contracts and other payor requirements, a local, state, or federal government agency or one of our customers may find the use of offshore resources to be a violation of a legal or contractual requirement, which could result in termination of the contractual relationship, penalties, or changes in our business operations that could adversely affect our business, financial condition, and results of operations.
13 unchanged sentences
These additional federal and state privacy and security-related laws may be more restrictive than HIPAA and could impose additional penalties.
−Removed: For example, the Federal Trade Commission uses its consumer
−Removed: protection authority under Section 5 of the Federal Trade Act to initiate enforcement actions in response to alleged privacy violations and data breaches.
+Added: For example, the Federal Trade Commission uses its consumer protection authority under Section 5 of the Federal Trade Act to initiate enforcement actions in response to alleged privacy violations and data breaches, including in the healthcare sector.
Additional data protection laws exist at the state level as well.
−Removed: California enacted the CCPA, which came into effect January 1, 2020, was amended and expanded by the CPRA, which came into effect January 1, 2023.
−Removed: The CCPA and CPRA, among other things, create data privacy obligations for covered companies and provide privacy rights to California residents, including the right to opt out of certain disclosures of their information.
+Added: California enacted the CCPA, which came into effect January 1, 2020, was amended and expanded by the California Privacy Rights Act (the “CPRA”), which came into effect January 1, 2023.
+Added: The CCPA, among other things, creates data privacy obligations for covered companies and provide privacy rights to California residents, including the right to opt out of certain disclosures of their information.
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.
1 unchanged sentence
It remains unclear what, if any, additional modifications will be made to this legislation or how it will be interpreted.
−Removed: The effects of the CCPA and CPRA 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.
+Added: 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.
There are also a number of other legislative proposals worldwide, including in the United States at both the federal and state level, that could impose additional and potentially conflicting obligations in areas affecting our business.
We expect to incur additional costs to ensure that our data privacy and security policies, procedures, and activities comply with applicable and evolving legal requirements.
−Removed: We are also subject to laws and regulations in foreign countries covering data privacy and other protection of health and employee information that may be more onerous than corresponding U.S.
+Added: We are also subject to laws and regulations in international countries covering data privacy and other protection of health and employee information that may be more onerous than corresponding U.S.
laws, including in particular the laws of Europe.
−Removed: 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 May 2018.
+Added: 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.
10 unchanged sentences
There are numerous and evolving risks to our cybersecurity and privacy from cyber threat actors.
−Removed: These cyber threat actors, whether internal of external to the Company, are becoming more frequent, sophisticated and coordinated in their attempts to access data, including third parties with whom the Company conducts business through, without limitation, malicious software;
+Added: These cyber threat actors, whether internal of external to Dexcom, are becoming more frequent, sophisticated and coordinated in their attempts to access data, including, without limitation, malicious software;
data privacy breaches by employees, insiders or others with authorized access;
1 unchanged sentence
attempts to gain unauthorized access to our data and systems;
+Added: vendor breaches or supply chain attacks;
and other electronic security breaches.
2 unchanged sentences
We have implemented and deploy multiple layers of security measures to protect the confidentiality, integrity and availability of this data and the systems and devices that store and transmit such data.
−Removed: We utilize current security technologies, and our defenses are monitored and routinely tested internally and by external parties.
+Added: We utilize security technologies, and our defenses are monitored and routinely tested internally and by external parties.
Despite these efforts, threats from malicious persons and groups, new vulnerabilities and advanced new attacks against information systems create risk of cybersecurity incidents.
34 unchanged sentences
• increase to insurance premiums;
−Removed: • foreign, federal and state governmental inquiries, violations or sanctions, any of which could have a material, adverse effect on our financial position and results of operations.
+Added: • international, federal and state governmental inquiries, violations or sanctions, any of which could have a material, adverse effect on our financial position and results of operations.
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.
−Removed: 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.
+Added: 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,
+Added: 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.
27 unchanged sentences
We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could become subject to penalties, be excluded from participation in government programs, and/or be required to make significant changes to our operations.
−Removed: The healthcare industry generally, and our business specifically, is subject to extensive foreign, federal, state and local laws and regulations, including those relating to:
+Added: The healthcare industry generally, and our business specifically, is subject to extensive international, federal, state and local laws and regulations, including those relating to:
• authorizations necessary for the clinical investigation and commercial marketing of products;
21 unchanged sentences
These laws and regulations are extremely complex and, in many cases, still evolving.
−Removed: If our operations are found to violate any of the foreign, 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
−Removed: curtailment of our operations.
+Added: 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.
3 unchanged sentences
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.
−Removed: 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.
+Added: 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
+Added: 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.
1 unchanged sentence
Any action against us alleging a violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s time and attention from the operation of our business, and have a material effect on our business.
+Added: As part of our commitment to technological advancement, we have incorporated and will continue to explore and implement AI-enabled functions into our products and services.
+Added: We continue to explore how best to leverage and harness the efficiency and innovation of AI-enabled and AI-empowered technology.
+Added: In our deployment of AI, we strive to continually assess its performance and continue to make improvements.
+Added: AI laws and regulations have proliferated in the U.S.
+Added: and globally in recent years, including in 2024.
+Added: In 2024, there were 60 AI-related regulations at the U.S.
+Added: federal and state levels, up from just one in 2016.
+Added: In 2024 alone, the total number of AI-related regulations in the U.S.
+Added: grew by 140%.
+Added: 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).
+Added: 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.
+Added: 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.
In addition, the laws and regulations impacting or affecting our business may change significantly in the future, which may adversely affect our business.
15 unchanged sentences
• unanticipated expenditures;
−Removed: • FDA refusal to issue certificates to foreign governments needed to export our products for sale in other countries;
+Added: • 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;
37 unchanged sentences
Since then we have received 510(k) clearances for modifications to the G6 and approval for G7.
+Added: 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.
Any subsequent modifications of our cleared products that could significantly affect their safety or effectiveness (for example, a significant change in design or manufacture), or that would constitute a major change in its intended use, will require us to obtain a new 510(k) clearance or could require a new de novo submission or a PMA.
15 unchanged sentences
• changes in FDA approval policies or adoption of new regulations may require additional data.
−Removed: Even if approved or cleared by the FDA or foreign regulatory agencies, future generations of our CGM systems, expanded indications for use of current and future generation CGM systems, our software platforms or any other CGM system under development, may not be cleared or approved for the indications that are necessary or desirable for successful commercialization.
−Removed: We may not obtain the necessary regulatory approvals or clearances to
−Removed: market these CGM systems in the United States or outside of the United States.
+Added: Even if approved or cleared by the FDA or international regulatory agencies, future generations of our CGM systems, expanded indications for use of current and future generation CGM systems, our software platforms or any other CGM system under development, may not be cleared or approved for the indications that are necessary or desirable for successful commercialization.
+Added: We may not obtain the necessary regulatory approvals or clearances to market these CGM systems in the United States or outside of the United States.
Any delay in, or failure to receive or maintain, clearance or approval for our products could prevent us from generating revenue from these products.
−Removed: 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.
+Added: The uncertain timing of regulatory approvals for future generations of our products could subject our current
+Added: 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.
2 unchanged sentences
We have in place a compliance program, through which we seek to reduce common industry risks of noncompliance with U.S.
−Removed: federal and state and applicable foreign laws in areas such as sales contracts, marketing materials, referral source relationships, programmatic offerings, and billing practices (among others), monitor for compliance, and address non-compliance if identified.
+Added: federal and state and applicable international laws in areas such as sales contracts, marketing materials, referral source relationships, programmatic offerings, and billing practices (among others), monitor for compliance, and address non-compliance if identified.
If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and our officers, directors and employees could be subject to criminal and civil penalties, as well as administrative sanctions such as exclusion from participation in federal healthcare programs, including but not limited to Medicare and Medicaid.
43 unchanged sentences
Changes to the regulatory landscape may impact our ability to obtain marketing authorization for future product developments.
−Removed: Development or changes to the FDA or foreign regulatory approval standards and processes, including both legal and policy changes, could also delay or prevent the approval of our products submitted for review.
+Added: Development or changes to the FDA or international regulatory approval standards and processes, including both legal and policy changes, could also delay or prevent the approval of our products submitted for review.
For example, medical device cybersecurity continues to be an area of focus for and evolving guidance from FDA.
28 unchanged sentences
These types of studies, which often require substantial investment and effort, may not show adequate, or any, clinical benefit or value for the use of CGM systems.
−Removed: Our CGM systems currently have regulatory marketing authorization limited to individual patient home-use, and have otherwise not received clearance or approval from the FDA or other regulators for use in hospital or other in-patient facility settings, although the FDA has advised us that it will not object to the use of our CGM systems in such settings during the COVID-19 pandemic.
−Removed: Our potential supply of our CGM systems for use in this environment during the COVID-19 pandemic may present risks to our business.
−Removed: We have received, and may continue to receive, numerous inquiries from hospitals around the country about the use of our CGM devices to remotely monitor COVID-19 patients admitted into the hospital.
−Removed: Following direct communication with the FDA regarding the potential use of our CGM devices in a hospital or other in-patient setting, the FDA notified us on April 1, 2020 that in an exercise of its enforcement discretion it will not object, in the context of the COVID-19 pandemic, to Dexcom providing CGM devices and support to users to enable real-time remote patient monitoring in hospitals and other healthcare facilities, to support COVID-19 healthcare-related efforts, so long as we provide certain FDA-specified information with respect to the unique challenges that CGM technologies can raise in the hospital environment.
−Removed: As a condition of its exercise of enforcement discretion, the FDA has advised that we communicate the following information related to implementing the use of CGM systems for remote monitoring of hospitalized patients:
−Removed: • Hospitals should consider whether they have the resources and expertise necessary to adequately implement CGM use and provide appropriate training to healthcare providers.
−Removed: • CGM glucose results are less accurate than blood glucose results obtained using traditional testing methods (e.g., lab glucose, blood glucose meters).
−Removed: Users should consider all CGM glucose information (e.g., trend) along with individual glucose values, and interpret CGM results in the context of the full clinical picture.
−Removed: • CGM systems are subject to interferences that may generate falsely high and falsely low glucose readings.
−Removed: Levels of interference depend on drug concentration;
−Removed: substances that may not significantly interfere in non-hospitalized patients may interfere when used in the hospital setting because of higher dose levels.
−Removed: Most drugs used in hospital or critical care settings have not been evaluated and their interference with CGM systems is unknown.
−Removed: Known interferences vary by CGM brand, and can include Acetaminophen, Ascorbic acid, Hydroxyurea, or other reducing drugs/ compounds.
−Removed: • Poor peripheral blood perfusion may cause inaccurate sensor readings.
−Removed: CGM results should be interpreted considering accompanying patient conditions and medications.
−Removed: Other clinical conditions may also cause inaccurate readings.
−Removed: Our provision of our CGM systems to hospitals and other healthcare facilities for use have and will continue to have the above notice.
−Removed: In February 2022, we received Breakthrough Device designation for our G6 CGM system in the hospital setting.
−Removed: The FDA’s Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that hold the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or condition.
−Removed: We are not actively promoting for inpatient use, but if we supply them to such facilities as currently permitted by the FDA, this supply could present an increased risk of product liability claims and associated damages should an adverse event occur.
−Removed: Given that our CGM devices have not yet been fully evaluated or tested by either us or 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.
−Removed: The FDA can also decide, at any time, to change its position regarding its Breakthrough Device Designation and/or enforcement discretion for our devices, and require that we seek marketing authorization for this additional intended use by submitting a 510(k) premarket notification, or that we seek and obtain Emergency Use Authorization.
−Removed: The COVID-19 public health emergency declared by the Department of Health and Human Services expired on May 11, 2023.
−Removed: While the end of the public health emergency does not by itself impact the FDA’s ability to authorize devices for emergency use, and the FDA has published guidance for transition plans for medical devices that fall within enforcement policies issued during the COVID-19 pandemic.
−Removed: We will continue to closely monitor regulatory developments that impact our products, business, or financial results, including those relating to FDA enforcement discretion and Breakthrough Device Designation for the provision of our CGM systems in the hospital setting.
We depend on clinical investigators and clinical sites to enroll patients in our clinical trials and other third parties to manage the trials and to perform related data collection and analysis, and, as a result, we may face costs and delays that are outside of our control.
16 unchanged sentences
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.
+Added: 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.
+Added: As such, our costs to monitor these changes and respond to new requirements will increase.
We cannot predict what additional new legislation, agency priorities, and rulemaking may be on the horizon as the United States continue to reassess how it pays for healthcare.
1 unchanged sentence
However, any changes that lower reimbursement for our products could materially and adversely affect our business, financial condition and results of operations.
−Removed: Other legal, regulatory and commercial policy influences are subjecting our industry to significant changes, and we cannot predict whether new regulations or policies will emerge from U.S.
−Removed: federal or state governments, foreign governments, or third-party payors.
+Added: Other legal, regulatory and commercial policy influences are subjecting our industry to significant changes, and we cannot predict what new regulations or policies will emerge from U.S.
+Added: federal or state governments, international governments, or third-party payors.
Government and commercial payors may, in the future, consider healthcare policies and proposals intended to curb rising healthcare costs, including those that could significantly affect reimbursement for healthcare products such as our systems.
2 unchanged sentences
imposing price controls and taxes on medical device providers;
−Removed: other measures.
+Added: and other measures.
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.
−Removed: 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.
+Added: These include changes that may reduce
+Added: 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
−Removed: We are subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages and injunctive relief.
+Added: We may be subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages and injunctive relief.
We may also be subject to other claims or suits.
−Removed: Third parties have asserted, and may assert, infringement or misappropriation claims against us with respect to our current or future products.
+Added: Third parties have asserted in the past, and may assert in the future, infringement or misappropriation claims against us with respect to our current or future products.
We are aware of numerous patents issued to third parties that may relate to aspects of our business, including the design and manufacture of CGM sensors and membranes, as well as methods for continuous glucose monitoring.
2 unchanged sentences
Our competitors may assert that our CGM systems or the methods we employ in the use of our systems are covered by U.S.
−Removed: or foreign patents held by them.
+Added: or international patents held by them.
We have in the past settled some such allegations and may need to do so again in the future.
5 unchanged sentences
We have been involved in various patent infringement actions in the past.
−Removed: For example, in July 2014, we entered into a Settlement and License Agreement with Abbott to settle all pending patent infringement legal proceedings brought by Abbott against us, which expired on March 31, 2021.
−Removed: Since the expiration of that agreement, we and certain Abbott entities have served complaints for patent infringement, validity, and other patent-related actions against each other in multiple jurisdictions, inside and outside the United States.
−Removed: We intend to vigorously pursue our claims and defenses in these cases to protect our intellectual property and to defend against Abbott’s infringement allegations.
+Added: 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.
+Added: 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.
3 unchanged sentences
We may be unable to maintain or renew licenses on terms acceptable to us, if at all, and we may be prohibited from selling any of our products that required the technology covered by the relevant licensed patents.
−Removed: Even if we are able to redesign our products to avoid an infringement claim, we may not receive FDA approval for such changes in a timely manner or at all.
+Added: Even if we are able to redesign our products to avoid an infringement claim, we may not receive FDA or international regulatory approval for such changes in a timely manner or at all.
Any adverse determination in litigation or interference proceedings to which we are or may become a party relating to patents or other intellectual property rights could subject us to significant liabilities to third parties or require us to seek licenses from other third parties.
5 unchanged sentences
We may be unable to obtain necessary intellectual property licenses on satisfactory terms.
−Removed: If we do not obtain any such necessary licenses, we may not be able to redesign our products to avoid infringement and any
−Removed: redesign may not receive FDA approval or other requisite marketing authorization in a timely manner or at all.
−Removed: 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.
+Added: 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.
+Added: Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary intellectual property
+Added: 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.
16 unchanged sentences
In addition, third parties may be able to design around our patents.
−Removed: Furthermore, the laws of foreign countries may not protect our proprietary rights to the same extent as the laws of the United States.
+Added: Furthermore, the laws of international countries may not protect our proprietary rights to the same extent as the laws of the United States.
Litigation Risks
15 unchanged sentences
Our customers, either on their own or following the advice of their physicians, may use our products in a manner not described in the products’ labeling and that differs from the manner in which it was used in clinical studies and approved by the FDA.
−Removed: For example, our current systems are designed to be used by an individual continuously for up to 10 days for our G6 and G7 systems, but the individual might be able to circumvent the safeguards designed into the systems and use the products for longer than 10 days.
+Added: For example, G6 and G7 are designed to be used by an individual continuously for up to 10 days, but the individual might be able to circumvent the safeguards designed into the systems and use the products for longer than 10 days.
Off-label use of products by customers is common, and any such off-label use of our products could subject us to additional liability, or require design changes to limit this potential off-label use once discovered.
18 unchanged sentences
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.
−Removed: It is also possible that other federal, state or foreign enforcement authorities might take action if they consider promotional, marketing or other materials
−Removed: 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.
+Added: It is also possible that other federal, state or international enforcement authorities might take action if they consider promotional, marketing or other
+Added: 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.
−Removed: We are not actively promoting nor do we plan to actively promote our G6 or G7 systems for inpatient use, but if we supply them to such facilities as currently permitted by FDA, this supply could present an increased risk of product liability claims and associated damages should an adverse event occur.
+Added: 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.
12 unchanged sentences
We have devoted substantial resources to:
−Removed: • research and development relating to our continuous glucose monitoring systems;
−Removed: • sales and marketing and manufacturing expenses associated with the commercialization of our CGM systems;
+Added: • research and development relating to our current and future products;
+Added: • sales and marketing and manufacturing expenses associated with the commercialization of our products;
• expansion of our workforce.
7 unchanged sentences
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.
−Removed: The loss of the services of members of our
−Removed: 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.
+Added: The loss of the services of members of our senior management, scientists, clinicians or engineers could prevent the implementation and completion of our
+Added: 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.
9 unchanged sentences
Further, the turnover in our employee base could result in operational and administrative inefficiencies, which could adversely impact the results of our operations, stock price and customer relationships, and could make recruiting for future management and other positions more difficult.
−Removed: We may conduct additional financings to continue the development or commercialization of our current or future generation CGM systems.
+Added: We may conduct additional financings to continue the development or commercialization of our current or future products.
Our operations have consumed substantial amounts of cash since inception.
−Removed: 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 next-generation CGM sensors and systems.
−Removed: 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 our next-generation sensors and systems or pursue other strategic initiatives.
+Added: 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.
+Added: 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.
Additional financing may not be available on a timely basis on terms acceptable to us, or at all.
19 unchanged sentences
The primary collection risks for our accounts receivable relate to the uninsured patient accounts and patient accounts for which the primary insurance carrier has paid the amounts covered by the applicable agreement, but patient responsibility amounts (exclusions, deductibles and copayments) remain outstanding.
−Removed: In addition, as a result of the economic slowdown, some customers have, and others may, lose access to their private health insurance plan if they lose their job.
+Added: In addition, as a result of recent economic conditions, some customers have, and others may, lose access to their private health insurance plan if they lose their job.
As most of our customers rely on third-party payors, including private health insurance plans, to cover the cost of our products, there has been, and may continue to be, a shift in financial responsibility to our customers for the amounts previously covered by their primary insurance carrier.
7 unchanged sentences
When these changes or events occur, we may incur costs to change our business strategy and may need to write-down the value of assets.
−Removed: For example, current economic conditions, including rising interest rates, inflation and a potential recession, as well as our business decisions, may reduce the value of some of our assets.
−Removed: 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 our planned construction of a new facility in Ireland.
+Added: 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.
+Added: 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.
22 unchanged sentences
or international tax legislation or additional tax liabilities.
−Removed: We are subject to taxes in the United States and numerous foreign jurisdictions, where a number of our subsidiaries are organized.
+Added: We are subject to taxes in the United States and numerous international jurisdictions, where a number of our subsidiaries are organized.
The tax laws in the United States and in other countries 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.
Further, due to economic and political conditions, tax rates in various jurisdictions may be subject to change.
−Removed: 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.
+Added: 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.
3 unchanged sentences
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.
−Removed: 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 will impact our business.
+Added: 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.
−Removed: government has recently enacted comprehensive tax legislation that includes significant changes to the taxation of business entities.
−Removed: These changes include, 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.
+Added: government enacted comprehensive tax legislation that included significant changes to the taxation of business entities.
+Added: 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.
−Removed: The overall impact of this tax reform is uncertain, and our business and financial condition could be adversely affected.
−Removed: In addition, it is uncertain if and to what extent various states will conform to the newly enacted federal tax law.
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.
2 unchanged sentences
These changes, when enacted by various countries in which we do business, may increase our taxes in these countries.
−Removed: Changes to these and other areas in relation to international tax reform, including future actions taken by foreign governments, could increase uncertainty and may adversely affect our tax rate and cash flow in future years.
+Added: Changes to these and other areas in relation to international tax reform, including future actions taken by international governments, could increase uncertainty and may adversely affect our tax rate and cash flow in future years.
Our tax returns and other tax matters also are subject to examination by the U.S.
18 unchanged sentences
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.
+Added: Additionally, in June 2024, the State of California enacted S.B.
+Added: 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.
+Added: The State of California also passed S.B.
+Added: 175 to provide for a potential early sunset of NOLs in either 2025 or 2026 if necessary.
+Added: See Note 8 “ Income Taxes ” to the consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K for additional information.
Risks Related to Our Common Stock
13 unchanged sentences
• legislation and political conditions;
−Removed: • global health pandemics, such as the recent COVID-19 pandemic;
+Added: • global health pandemics, such as the COVID-19 pandemic;
• the consummation of, and anticipated benefits of, our share repurchase programs;
4 unchanged sentences
Securities class action litigation has often been brought against public companies that experience periods of volatility in the market prices of their securities.
+Added: For example, we have pending securities class action litigation and a derivative action 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.
The issuance of shares by us in the future or sales of shares by our stockholders may cause the market price of our common stock to drop significantly, even if our business is performing well.
−Removed: This issuance of shares by us in the future, including by conversion of our senior convertible notes in certain circumstances, the issuance of shares of our common stock to partners, including up to 1.5 million additional shares of our common stock that we may issue to Verily pursuant to the Restated Collaboration Agreement, or sales of shares by our stockholders may cause the market price of our common stock to decline, perhaps significantly, even if our business is performing well.
+Added: This issuance of shares by us in the future, including by conversion of our senior convertible notes in certain circumstances, or sales of shares by our stockholders may cause the market price of our common stock to decline, perhaps significantly, even if our business is performing well.
The market price of our common stock could also decline if there is a perception that sales of our shares are likely to occur in the future.
−Removed: This might also make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.
+Added: This might also make it more difficult for us to sell securities in the future at a time and at a price that we deem appropriate.
Also, we may issue securities in connection with future financings and acquisitions, and those shares could dilute the holdings of other stockholders.
6 unchanged sentences
• our Board of Directors may, without stockholder approval, issue shares of preferred stock with special voting or economic rights;
−Removed: • our stockholders do not have cumulative voting rights and, therefore, each of our directors can only be elected by holders of a majority of our outstanding common stock;
−Removed: • a special meeting of stockholders may only be called by a majority of our Board of Directors, the Chairman of our Board of Directors, our Chief Executive Officer, our President or our Lead Independent Director;
+Added: • our stockholders do not have cumulative voting rights;
+Added: • a special meeting of stockholders may only be called by a majority of our Board of Directors, upon direction of the Chairman of our Board of Directors, our Chief Executive Officer, our President or our Lead Independent Director, or a majority of our Board of Directors;
• our stockholders may not take action by written consent;
1 unchanged sentence
Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all claims brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.
−Removed: Our bylaws provide that the federal district courts of the United States will, to the fullest extent permitted by law, be the exclusive
−Removed: forum for resolving any complaint asserting a cause of action arising under the Securities Act, or a Federal Forum Provision.
+Added: Our bylaws provide that the federal district courts of the United States will, to the fullest extent permitted by law, be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, or a Federal Forum Provision.
Our decision to adopt a Federal Forum Provision followed a decision by the Supreme Court of the State of Delaware holding that such provisions are facially valid under Delaware law.
20 unchanged sentences
• the possible diversion of capital resources from other uses.
−Removed: While we believe we will have the ability to service our debt and obtain additional resources in the future if and when needed, that will depend upon our results of operations and financial position at the time, the then-current state of the credit and financial markets, and other factors that may be beyond our control.
+Added: The Amended Credit Agreement expires in 2026.
+Added: While we believe we will have the ability to service our debt, extend the term of the credit agreement, and/or obtain additional resources in the future if and when needed, that will depend upon our results of operations and financial position at the time, the then-current state of the credit and financial markets, and other factors that may be beyond our control.
Therefore, we cannot give assurances that sufficient credit will be available on terms that we consider attractive, or at all, if and when necessary or beneficial to us.
2 unchanged sentences
As of December 31, 2024, we were in compliance with the covenants imposed by the Amended Credit Agreement.
−Removed: If we violate these or any other covenants, any outstanding amounts under the Amended Credit Agreement could become due and payable prior to
−Removed: 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.
+Added: 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.
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.
7 unchanged sentences
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.
−Removed: As a result of our level of increased debt after the completion of the Notes Offerings:
−Removed: • our vulnerability to adverse general economic conditions and competitive pressures will be heightened;
−Removed: • we will be required to dedicate a larger portion of our cash flow from operations to interest payments, limiting the availability of cash for other purposes;
−Removed: • our flexibility in planning for, or reacting to, changes in our business and industry may be more limited;
−Removed: • our ability to obtain additional financing in the future for working capital, capital expenditures, acquisitions, general corporate purposes or other purposes may be impaired.
−Removed: We cannot be sure that our leverage resulting from the level of increased debt after the completion of the Notes Offerings will not materially and adversely affect our ability to finance our operations or capital needs or to engage in other business activities.
+Added: Our level of debt may:
+Added: • heighten our vulnerability to adverse general economic conditions and competitive pressures;
+Added: • require us to dedicate a larger portion of our cash flow from operations to interest payments, limiting the availability of cash for other purposes;
+Added: • limit our flexibility in planning for, or reacting to, changes in our business and industry;
+Added: • impair our ability to obtain additional financing in the future for working capital, capital expenditures, acquisitions, general corporate purposes or other purposes.
+Added: We cannot be sure that our leverage will not materially and adversely affect our ability to finance our operations or capital needs or to engage in other business activities.
In addition, we cannot be sure that additional financing will be available when required or, if available, will be on terms satisfactory to us.
5 unchanged sentences
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.
−Removed: 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.
+Added: 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
+Added: 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.
−Removed: Our failure to repurchase Notes at a time when the repurchase is required by the respective
−Removed: 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.
+Added: 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.
11 unchanged sentences
Any of these activities could adversely affect the value of 2028 Notes or our common stock (and as a result, the amount and value of the consideration that a holder would receive upon the conversion of any 2028 Notes) and, under certain circumstances, a holder’s ability to convert its notes.
−Removed: The warrants related to the 2023 Notes and our common stock.
−Removed: In connection with the sale of the 2023 Notes, we entered into warrant transactions with the option counterparties pursuant to which we sold warrants for the purchase of our common stock, or the 2023 Warrants.
−Removed: The 2023 Warrant transactions could separately have a dilutive effect to the extent that the market price per share of our common stock exceeds the exercise price of the 2023 Warrants, which is $49.60.
−Removed: We do not make any representation or prediction as to the direction or magnitude of any potential effect that the 2023 Warrants may have on our common stock.
−Removed: In addition, we do not make any representation that the option counterparties will engage in these transactions or that these transactions, once commenced, will not be discontinued without notice.
We are subject to counterparty risk with respect to the 2028 Capped Calls.
7 unchanged sentences
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.
−Removed: 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.
+Added: 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
+Added: 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.
4 unchanged sentences
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.
−Removed: Our Credit Facility imposes restrictions on us that may adversely affect our ability to operate our business.
−Removed: Our Credit Facility contains restrictive covenants relating to our capital raising activities and other financial and operational matters which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions.
−Removed: In addition, our Credit Facility 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.
+Added: Our Amended Credit Agreement imposes restrictions on us that may adversely affect our ability to operate our business.
+Added: Our Amended Credit Agreement contains restrictive covenants relating to our capital raising activities and other financial and operational matters which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions.
+Added: 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.
−Removed: 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 Credit Facility.
−Removed: The occurrence of a default under any of these borrowing arrangements would permit the holders of the Notes or the lenders under our Credit Facility to declare all amounts outstanding under those borrowing arrangements to be immediately due and payable.
−Removed: If the Note holders or the trustee under the indenture governing the Notes or the lenders under our Credit Facility accelerate the repayment of borrowings, we cannot assure you that we will have sufficient assets to repay those borrowings.
+Added: 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.
+Added: The occurrence of a default under any of these borrowing arrangements would permit the holders of the Notes or the lenders under our Amended Credit Agreement to declare all amounts outstanding under those borrowing arrangements to be immediately due and payable.
+Added: If the Note holders or the trustee under the indenture governing the Notes or the lenders under our Amended Credit Agreement accelerate the repayment of borrowings, we cannot assure you that we will have sufficient assets to repay those borrowings.
Conversion of the Notes will, to the extent we deliver shares upon conversion of such Notes, dilute the ownership interest of existing stockholders, including holders who had previously converted their Notes, or may otherwise depress our stock price.
8 unchanged sentences
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.
−Removed: 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.
+Added: If one or more holders elect to convert their Notes, unless
+Added: 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.
7 unchanged sentences
Risks Related to Environmental, Social and Governance Matters
−Removed: Environmental, social and governance, or ESG, regulations, policies and provisions could expose us to numerous risks.
−Removed: Increasingly, regulators, customers, investors, employees and other stakeholders are focusing on ESG matters and related disclosures.
−Removed: These changing rules, regulations and stakeholder expectations have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent complying with or meeting such regulations and expectations.
−Removed: For example, collecting, measuring and reporting ESG-related data and information is subject to evolving reporting standards, including the SEC’s proposed climate-related reporting requirements, and similar proposals by other international regulatory bodies.
−Removed: For example, in 2023, California passed three separate climate bills governing disclosure of greenhouse gas emissions data, climate-related financial risks, and details around emissions-related claims and carbon offsets.
−Removed: In addition, a number of our customers who are payors or distributors have adopted, or may adopt, procurement policies that include ESG provisions that their suppliers or manufacturers must comply with, or they may seek to include such provisions in their terms and conditions.
−Removed: An increasing number of participants in the medical device industry are also joining voluntary ESG groups or organizations, such as the Responsible Business Alliance.
−Removed: These ESG provisions and initiatives are subject to change, can be unpredictable, and may be difficult and expensive for us to comply with, given the complexity of our supply chain and the outsourced manufacturing of certain components of our products.
−Removed: If we are unable to comply, or are unable to cause our suppliers to comply, with such policies or provisions, a customer may stop purchasing products from us, and may take legal action against us, which could harm our reputation, revenue and results of operations.
−Removed: Our business could be negatively impacted by evolving expectations and challenges relating to implementing ESG initiatives, setting ESG-related goals, collecting ESG-related data, and disclosing ESG-related information.
−Removed: We may communicate certain initiatives and goals regarding ESG-related matters in our SEC filings or in other public disclosures.
−Removed: These ESG-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.
−Removed: Further, statements about our ESG-related initiatives and goals, and progress against those 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 in the future.
+Added: Sustainability (including environmental, social and governance) regulations, policies and provisions could expose us to numerous risks.
+Added: Increasingly, regulators, customers, investors, employees and other stakeholders are focusing on sustainability matters relating to businesses, including climate change and greenhouse gas emissions, human and civil rights, and diversity, equity and inclusion.
+Added: These changing rules, regulations and stakeholder expectations may differ and conflict, and have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent complying with or meeting such regulations and expectations.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Further, a number of governments are considering due diligence procedures to ensure strict compliance with environmental, labor, and government regulations.
+Added: For example, the European Union has recently proposed broad due diligence reporting requirements for all industries operating within Europe.
+Added: 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.
+Added: An increasing number of participants in the medical device industry are also joining voluntary sustainability groups or organizations, such as the Responsible Business Alliance.
+Added: These sustainability regulations, provisions and initiatives are subject to change, can be unpredictable and conflicting, and may be difficult, expensive and time consuming for us to comply with, given the complexity of our value chain and the outsourced manufacturing of certain components of our products.
+Added: If we are unable to comply, or are unable to cause our upstream and downstream stakeholders to comply, with such regulations, policies or provisions, it may impact our ability to do business, or otherwise present barriers to entry, which could harm our reputation, revenue and results of operations.
+Added: 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.
+Added: 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.
+Added: 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
+Added: the accuracy, adequacy or completeness of the disclosure.
+Added: 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.
In addition, we could be criticized for the scope or nature of such initiatives or goals, or for any revisions to these goals.
−Removed: If our ESG-related data, processes and reporting are incomplete or inaccurate, or if we fail to achieve progress with respect to our ESG-related goals on a timely basis, or at all, our reputation, business, financial performance and growth could be adversely affected.
+Added: 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.
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.
−Removed: Access to clean water and reliable energy in the communities where we conduct our business, whether for our offices or for our vendors, is a priority.
+Added: 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.
15 unchanged sentences
Our operations and performance depend on worldwide economic and political conditions.
−Removed: These conditions have been adversely impacted by continued global economic uncertainty, political instability and military hostilities in multiple geographies, monetary and financial uncertainties in Europe and other foreign countries, global health pandemics, rising interest rates, and domestic and global inflationary trends.
+Added: These conditions have been adversely impacted by continued global economic uncertainty, political instability and military hostilities in multiple geographies, monetary and financial uncertainties in Europe and other international countries, global health pandemics, rising interest rates, and domestic and global inflationary trends.
These include potential reductions in the overall stability and suitability of the Euro as a single currency, given the economic and political challenges facing individual Eurozone countries.
1 unchanged sentence
If that were to occur, our revenue may decrease and our performance may be negatively impacted.
+Added: We expect continued uncertainty and potential political disputes between countries, which could have adverse operation and economic impacts on our business.
In addition, the pressure on consumers to absorb more of their own health care costs has resulted in some cases in higher deductibles and limits on durable medical equipment, which may cause seasonality in purchasing patterns.
5 unchanged sentences
Inflation has the potential to adversely affect our liquidity, business, financial condition and results of operations by increasing our overall cost structure.
−Removed: The existence of inflation in the economy has resulted in, and may continue to
−Removed: result in, higher interest rates and capital costs, supply shortages, increased costs of labor, components, manufacturing and shipping, as well as weakening exchange rates and other similar effects.
+Added: The existence of inflation in the economy has resulted in, and may continue to result in, higher interest rates and capital costs, supply shortages, increased costs of labor, components, manufacturing and shipping, as well as weakening exchange rates and other similar effects.
As a result of inflation, we have experienced and may continue to experience cost increases.
17 unchanged sentences
If quarterly revenues or operating results fall below the expectations of investors or public market analysts, the trading price of our common stock could decline substantially.
−Removed: Factors that might cause quarterly fluctuations in our operating results include:
+Added: In addition to the other risk factors set forth herein, factors that might cause quarterly fluctuations in our operating results include:
• our inability to manufacture an adequate supply of product at appropriate quality levels and acceptable costs;
4 unchanged sentences
• failures to comply with regulatory requirements, which could lead to withdrawal of products from the market;
−Removed: • our failure to continue the commercialization of any of our CGM systems;
+Added: • our failure to continue the commercialization of any of our products;
• competition;
2 unchanged sentences
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.