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• Failure to secure or retain adequate coverage or reimbursement for our current and future products by third-party payors could adversely affect our business, financial condition and operating results.
+Added: • We operate in a very competitive industry and if we fail to compete successfully against our existing or future competitors, or if the competitive environment harms our business partners, our financial condition and operating results may be negatively affected.
• Competing products, therapeutic techniques or other technological developments and breakthroughs for the monitoring, treatment or prevention of diabetes may render our products obsolete or less desirable or reduce the size of our potential market.
+Added: • We may face unexpected challenges in marketing and selling our products, and training new customers on the use of our products, which could harm our ability to achieve our sales forecasts.
• Our sales and marketing efforts in the United States are largely dependent on independent distributors who are free to market products that compete with our products.
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• Commercializing our products outside of the United States may result in a variety of risks associated with international operations that could materially adversely affect our business.
−Removed: • Failure to obtain any required regulatory authorization, clearance or certification in foreign jurisdictions will prevent us from marketing our products in international markets.
Risks Related to Our Indebtedness
−Removed: • We have incurred a significant amount of indebtedness and the agreements governing such indebtedness subject us to required debt service payments, as well as financial and operational covenants, any of which may restrict our financial flexibility and affect our ability to operate our business.
−Removed: • Servicing our senior convertible notes (the Notes) will require a significant amount of cash, and we may not have sufficient cash flow from our business to repay the Notes.
+Added: • We have incurred a significant amount of indebtedness and the agreements governing such indebtedness subject us to required debt service payments, any of which may restrict our financial flexibility and affect our ability to operate our business.
Risks Related to Our Future Financings and Financial Results
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• Uncertainty in current global economic and political conditions could adversely affect our ability to predict product demand and impact our financial results and make it more likely that our actual results could differ materially from expectations.
−Removed: • Public health threats, epidemics, or pandemics could have a material adverse effect on our operations, the operations of our business partners, and the global economy as a whole.
• Because our business is global, our sales and profits may fluctuate or decline in response to changes in foreign currency exchange rates or other international risks.
−Removed: • Climate change or other extreme weather conditions and related regulations may have a long-term impact on our business.
Risks Related to Privacy and Security
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• Patent litigation in the medical device industry is common, and we may be subject to litigation that could cause us to incur substantial costs and divert the attention of management from our business.
−Removed: • We may be subject to damages resulting from claims that we, or our employees, have wrongfully used or disclosed trade secrets or other proprietary information of our competitors.
Risks Related to Our Regulatory Environment
• Our products and operations are subject to extensive governmental regulation, and failure to comply with applicable requirements could cause our business to suffer.
−Removed: • New products or modifications to our existing products may require new 510(k) clearances, PMAs or certifications, or may require us to cease marketing or recall the modified products until clearances, certifications or approvals are obtained.
• A recall or suspension of our products, or the discovery of serious safety issues with our products, could have a significant negative impact on us.
−Removed: • The price of our common stock may continue to fluctuate significantly.
• We depend on the knowledge and skills of our senior management and other key employees, and if we are unable to retain and motivate them or recruit additional qualified personnel, our business may suffer.
• Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
−Removed: • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud, which could harm our business and result in a decline in the trading price of our common stock.
An investment in our common stock, or in securities convertible into or exchangeable for our common stock, involves a high degree of risk.
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Since our inception in January 2006, we have incurred a significant net loss.
−Removed: As of March 31, 2025, we had an accumulated deficit of $1.2 billion.
+Added: As of June 30, 2025, we had an accumulated deficit of $1.2 billion.
To date, we have funded our operations primarily through cash collected from product sales, private and public offerings of our equity securities, and debt financings.
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Although we have achieved a positive overall gross margin during the years ended December 31, 2024, 2023 and 2022, we had net losses from operations in those years, and we may continue to incur net losses from operations in the future.
−Removed: To implement our business strategy and achieve consistent profitability, we need to, among other things, increase sales of our products and the gross profit associated with those sales, maintain an appropriate customer service, training and support infrastructure, fund ongoing research and development (R&D) activities, create additional efficiencies in our manufacturing processes while adding to our capacity, and obtain regulatory clearance, certification or approval to commercialize our products currently under development both in the United States and the 24 countries outside the United States in which our insulin pumps are available.
+Added: To implement our business strategy and achieve consistent profitability, we need to, among other things, increase sales of our products through various sales channels and the gross profit associated with those sales, maintain an appropriate customer service, training and support infrastructure, fund ongoing research and development (R&D) activities, create additional efficiencies in our manufacturing processes while adding to our capacity, and obtain regulatory clearance, certification or approval to commercialize our products currently under development both in the United States and the 24 countries outside the United States in which our insulin pumps are available.
We expect our expenses will continue to increase as we pursue these objectives and make investments in our business.
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We currently rely on sales of insulin pump products to generate a significant portion of our revenue, and any factors that negatively impact sales of these products may adversely affect our business, financial condition and operating results.*
−Removed: We generate nearly all of our revenue from the sale of our insulin pumps and the related insulin cartridges and infusion sets, including our recently launched Tandem Mobi insulin pump.
+Added: We generate nearly all of our revenue from the sale of our insulin pumps and the related insulin cartridges and infusion sets.
Sales of these products may be negatively impacted by many factors, including:
−Removed: • market acceptance of the insulin pumps and related products manufactured and sold by our key competitors, including Insulet, Medtronic, Ypsomed and Beta Bionics;
+Added: • market acceptance of the insulin pumps and related products manufactured and sold by our key competitors, including Beta Bionics, Insulet, Medtronic, Sequel and Ypsomed;
• the potential that breakthroughs for the monitoring, treatment or prevention of diabetes may render our insulin pumps obsolete or less desirable or reduce the size of our potential market;
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• our inability to enter into contracts with third-party payors on a timely basis and on acceptable terms;
+Added: • our inability to expand our sales channels, including the pharmacy channel in the United States;
• problems arising from the expansion of our manufacturing capabilities and commercial operations, or destruction, loss, or temporary shutdown of our manufacturing facilities;
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A key to maintaining and growing our revenue is the retention of a high percentage of our customers due to the potentially significant revenue generated from ongoing purchases of single-use infusion sets, insulin cartridges and other supplies.
−Removed: In addition, our pumps are designed and tested to remain effective for at least four years and a customer may consider purchasing another product from us when the time comes to replace the pump.
−Removed: We have developed retention programs aimed at our customers, their caregivers and healthcare providers, which include discounts, training specific to our products, ongoing support by our sales and clinical employees, and technical support and customer service.
+Added: In addition, our pumps are designed and tested to remain effective for at least four years and a customer may consider purchasing another pump from us when the time comes to replace it.
+Added: We have developed retention programs aimed at our customers, their caregivers and healthcare providers, which include training specific to our products, ongoing support by our sales and clinical employees, and technical support and customer service.
Demand for our products from our existing customers could decline or could fail to increase as anticipated or projected as a result of a number of factors, including the introduction of competing products, breakthroughs for the monitoring, treatment or prevention of diabetes, changes in reimbursement rates or policies, manufacturing problems, perceived safety or reliability issues with our products or components or the products of our competitors, the failure to secure regulatory clearance, certification, or approvals for products or product features in a timely manner or at all, product development or commercialization delays, the impacts and disruption from health epidemics or pandemics, international conflicts, or for other reasons.
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Access to adequate coverage and reimbursement for our current and future products by third-party payors is essential to the acceptance of our products by customers.
−Removed: As guidelines in setting their coverage and reimbursement policies, many third-party payors in the United States use coverage decisions and payment amounts determined by the Centers for Medicare and Medicaid Services (CMS), which administers the U.S.
−Removed: Medicare program.
+Added: In July 2025, the Centers for Medicare and Medicaid Services (CMS), which administers the U.S.
+Added: Medicare program, outlined a proposed competitive bidding process for some medical equipment, including continuous glucose monitors and insulin pumps that could affect reimbursement rates for our products.
+Added: In addition, CMS outlined a proposed change in payment for these devices to a monthly rental basis which could impact when our pumps are shipped and corresponding revenue is recognized.
+Added: As guidelines in setting their coverage and reimbursement policies, many third-party payors in the United States use coverage decisions and payment amounts determined by CMS.
Medicare periodically reviews its reimbursement practices for diabetes-related products, and there is uncertainty as to the future Medicare coverage structure and reimbursement rate for our products.
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For instance, it is possible that third-party payors may adopt policies in the future that designate one or more of our competitors as their preferred, in-network durable medical equipment provider of insulin pumps and that such policies would discourage or prohibit the payors’ members from purchasing our products, which would adversely impact our ability to sell our products.
−Removed: We are pursuing a multi-channel managed care strategy and have begun offering certain products through the pharmacy channel.
−Removed: However, the commercial opportunity in the pharmacy channel will be limited unless a substantial portion of the sales price for these products is covered by third-party payors, including private insurance companies, health maintenance organizations, preferred provider organizations, federal and state government healthcare agencies, intermediaries, Medicare, Medicaid and other managed care providers.
+Added: We are pursuing a multi-channel managed care strategy and have begun offering Tandem Mobi through the pharmacy channel and are preparing to offer cartridge and infusion sets for the t:slim X2 customers through the pharmacy channel beginning in the fourth quarter of 2025.
+Added: However, the commercial opportunity in the pharmacy channel will be limited unless a substantial portion of the sales price for any products offered through the pharmacy channel is covered by third-party payors, including private insurance companies, health maintenance organizations, preferred provider organizations, federal and state government healthcare agencies, intermediaries, Medicare, Medicaid and other managed care providers.
Medicare Part D plan sponsors may provide coverage for certain products under the Medicare Part D prescription drug program, which requires negotiating with third-party payors to provide these products through the pharmacy channel in the United States.
−Removed: If our efforts to enter into additional contracts with intermediaries and third-party payors are not successful, our ability to offer Mobi or any future products through the pharmacy channel will be limited.
+Added: If our efforts to enter into and maintain additional contracts with intermediaries and third-party payors for products we offer or seek to offer through the pharmacy channel take longer than anticipated or are not successful, our ability to successfully offer these products or any future products through the pharmacy channel will be limited.
We believe that there will continue to be proposals by legislators at both the federal and state levels, regulators and third-party payors to reduce costs while expanding individual healthcare benefits, particularly in light of the change of administration.
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Failure to secure or retain adequate coverage or reimbursement for our current and future products by third-party payors, or delays in processing approvals by those payors, could result in the loss of sales, which could have a material adverse effect on our business, financial condition and operating results.
−Removed: Further, the healthcare industry in the United States is increasingly focused on cost containment as government and private insurers seek to control healthcare costs by imposing lower payment rates and negotiating reduced contract rates with third-party payors.
+Added: Further, the healthcare industry continues to be increasingly focused on cost containment as government and private insurers seek to control healthcare costs by imposing lower payment rates and negotiating reduced contract rates with third-party payors.
If third-party payors deny coverage or reduce their current levels of payment, or if our production costs increase faster than increases in reimbursement levels, we may be unable to sell our products on a profitable basis.
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Given these factors, we cannot guarantee that we will be able to compete effectively or continue our level of success.
−Removed: Our primary competitors are major medical device companies, primarily Insulet, Medtronic, Ypsomed and Beta Bionics.
+Added: Our primary competitors are major medical device companies, primarily Beta Bionics, Insulet, Medtronic, Sequel and Ypsomed.
There are also a number of other companies developing and marketing their own insulin delivery systems and/or related software applications, including insulin pumps and Bluetooth-enabled insulin pens to support MDI therapy.
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For example, we have entered into development agreements with Dexcom, which provide us with non-exclusive licenses to integrate various generations of Dexcom CGM technology with our insulin pump products.
−Removed: Abbott also offers glucose sensors which compete with Dexcom CGMs.
We have also entered into agreements with Abbott to develop and commercialize integrated diabetes solutions using Abbott’s glucose sensors.
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In addition, even the perception that new products may be introduced, or that technological or treatment advancements could occur and could result in delayed purchases or a decline in market share.
−Removed: For example, in 2023 and 2024, ongoing adoption of the GLP-1 class of drugs in diabetes and news surrounding the expansion of use of GLP-1 drugs in obesity likely had a negative impact on the insulin therapy market.
+Added: For example, since 2023, ongoing adoption of the GLP-1 class of drugs in diabetes and news surrounding the expansion of use of GLP-1 drugs in obesity likely had a negative impact on the insulin therapy market.
Because the insulin-dependent diabetes market is large and growing, we anticipate companies will continue to dedicate significant resources to developing competing products and technologies.
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As demand for our products increases, and as the number of our commercial products expands, we will have to invest additional resources to purchase components, hire and train employees, and enhance our manufacturing processes and quality systems.
−Removed: We may also increase our utilization of third parties to perform contracted manufacturing services for us, and we may need to acquire additional custom designed equipment to support the expansion of our manufacturing capacity.
−Removed: In addition, although we expect some of our products under development to share product features and components with our current products, manufacturing of these products may require modification of our production lines, hiring of specialized employees, identification of new suppliers for specific components, qualifying and implementing additional equipment and procedures, obtaining new regulatory clearances, certifications, or approvals, or developing new manufacturing technologies.
+Added: We have also increased our use of third parties to perform contracted manufacturing services for us and failure in our oversight of these third parties or any disruption to their network business could negatively impact our business operations.
+Added: We may also need to acquire additional custom designed equipment to support the expansion of our manufacturing capacity.
+Added: In addition, although we expect some of our products under development to share product features and components with our current products, manufacturing of these products may require modifying our production lines, hiring specialized employees, identifying new suppliers for specific components, qualifying and implementing additional equipment and procedures, obtaining new regulatory clearances, certifications, or approvals, or developing new manufacturing technologies.
Ultimately, it may not be possible for us to manufacture these products at a cost or in quantities sufficient to make these products commercially viable.
−Removed: If we and our suppliers fail to increase our production capacity to meet consumer demand while also maintaining product quality standards, obtaining and maintaining regulatory clearances, certifications, or approvals, and efficiently managing costs, our sales and operating margins could be negatively impacted, which would have an adverse impact on our financial condition and operating results.
+Added: If we, our contract manufacturers or our suppliers fail to increase our production capacity to meet consumer demand while also maintaining product quality standards, obtaining and maintaining regulatory clearances, certifications, or approvals, and efficiently managing costs, our sales and operating margins could be negatively impacted, which would have an adverse impact on our financial condition and operating results.
We depend on a limited number of third-party suppliers for certain components and products, and the loss of any of these suppliers, their inability to provide us with an adequate supply of components or products, or our inability to adequately forecast customer demand, could harm our business.
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Modifications to our business strategy or restructuring of our operations could lead to higher costs or otherwise impact the profitability of our business or the value of our assets.*
−Removed: As changes occur in our business environment, we have adjusted, and may continue to adjust, our business strategies.
+Added: As changes occur in our business environment, we have adjusted, and may continue to adjust, our business strategies, including our pursuit of a multi-channel managed care strategy to include offering certain products through the pharmacy channel.
We may also decide to further restructure our operations, specific business functions, or assets.
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Risks Related to Our Indebtedness
−Removed: We have incurred a significant amount of indebtedness, and the agreements governing such indebtedness subject us to required debt service payments, as well as financial and operational covenants, any of which may restrict our financial flexibility and affect our ability to operate our business.
+Added: We have incurred a significant amount of indebtedness, and the agreements governing such indebtedness subject us to required debt service payments, any of which may restrict our financial flexibility and affect our ability to operate our business.*
From time to time, we have financed our liquidity needs under various credit arrangements and we may borrow additional funds in the future.
−Removed: For example, in May 2020, we completed the offering of $287.5 million aggregate principal amount of 1.50% Convertible Senior Notes due 2025 (the 2025 Notes), which are governed by the terms of an indenture (the 2025 indenture).
−Removed: In March 2024, we completed the offering of $316.3 million aggregate principal amount of 1.50% Convertible Senior Notes due 2029 (the 2029 Notes and, together with the 2025 Notes, the Notes), which are governed by the terms of an indenture (the 2029 indenture and, together with the 2025 Notes, the indentures).
−Removed: In March 2024, we used the proceeds from the offering of the 2029 Notes to repurchase approximately $246.7 million aggregate principal amount of the 2025 Notes in privately negotiated transactions with holders of the 2025 Notes and as of March 31, 2025, we had approximately $40.8 million aggregate principal amount of the 2025 Notes outstanding.
+Added: For example, in May 2020, we completed the offering of $287.5 million aggregate principal amount of 1.50% Convertible Senior Notes due 2025 (the 2025 Notes).
+Added: In March 2024, we completed the offering of $316.3 million aggregate principal amount of 1.50% Convertible Senior Notes due 2029 (the 2029 Notes), which are governed by the terms of an indenture (the indenture).
+Added: In March 2024, we used the proceeds from the offering of the 2029 Notes to repurchase approximately $246.7 million aggregate principal amount of the 2025 Notes in privately negotiated transactions with holders of the 2025 Notes and in the second quarter of 2025, all remaining 2025 Notes were paid in full.
The 2029 Notes are our senior unsecured obligations, and interest on the 2029 Notes is payable in cash semi-annually at a rate of 1.50% per year.
−Removed: Our failure to comply with certain obligations under the Notes, or inability to make required debt service payments, could result in an event of default under the relevant indenture.
+Added: Our failure to comply with certain obligations under the 2029 Notes, or inability to make required debt service payments, could result in an event of default under the indenture.
A default, if not cured or waived, could result in acceleration of the indebtedness, which could have a material adverse effect on our business, financial condition and liquidity.
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We may not have sufficient cash or be able to obtain financing to repurchase the 2029 Notes upon a fundamental change, or to settle conversions of the 2029 Notes.*
−Removed: Holders of the Notes have the right to require us to repurchase their Notes upon the occurrence of a fundamental change (as defined in the applicable indenture governing the Notes) at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any.
−Removed: In addition, upon conversion of the Notes, unless we elect to deliver solely shares of our common stock to settle such conversion, we will be required to settle all or a portion of our
−Removed: conversion obligation through the payment of cash, which could adversely affect our liquidity.
+Added: Holders of the 2029 Notes have the right to require us to repurchase their 2029 Notes upon the occurrence of a fundamental change (as defined in the indenture) at a repurchase price equal to 100% of the principal amount of the 2029 Notes to be repurchased, plus accrued and unpaid interest, if any.
+Added: In addition, upon conversion of the 2029 Notes, unless we elect to deliver solely shares of our common stock to settle such conversion, we will be required to settle all or a portion of our conversion obligation through the payment of cash, which could adversely affect our liquidity.
However, we may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of the 2029 Notes or settle conversions of the 2029 Notes.
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The Capped Call Transactions may affect the value of the 2029 Notes and our common stock.*
−Removed: In connection with the issuance of the 2025 Notes, we entered into capped call transactions (the 2025 Capped Call Transactions) with certain financial institutions (the option counterparties) and in connection with the issuance of the 2029 Notes, we entered into capped call transactions (the 2029 Capped Call Transactions and, together with the 2025 Capped Call Transactions, the Capped Call Transactions) with certain financial institutions (the 2029 option counterparties and, together with the 2025 option counterparties, the option counterparties).
−Removed: The Capped Call Transactions are expected generally to reduce the potential dilution to our common stock upon any conversion of the Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap.
−Removed: The option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock and/or purchasing or selling our common stock or other securities of ours in secondary market transactions before the applicable maturity of the Notes.
+Added: In connection with the issuance of the 2029 Notes, we entered into capped call transactions (the 2029 Capped Call Transactions) with certain financial institutions (the 2029 option counterparties).
+Added: The 2029 Capped Call Transaction is expected generally to reduce the potential dilution to our common stock upon any conversion of the 2029 Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted 2029 Notes, as the case may be, with such reduction and/or offset subject to a cap.
+Added: The 2029 option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock and/or purchasing or selling our common stock or other securities of ours in secondary market transactions before the maturity of the 2029 Notes.
This activity could also cause or avoid an increase or a decrease in the market price of our common stock or the 2029 Notes, which could affect a note holder’s ability to convert the 2029 Notes.
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The 2029 option counterparties are financial institutions, and we will be subject to the risk that any or all of them may default under the 2029 Capped Call Transactions.
−Removed: If an option counterparty becomes subject to insolvency proceedings, we will become an unsecured creditor in those proceedings with a claim equal to our exposure at that time under the Capped Call Transaction with such option counterparty.
+Added: If a 2029 option counterparty becomes subject to insolvency proceedings, we will become an unsecured creditor in those proceedings with a claim equal to our exposure at that time under the 2029 Capped Call Transaction with such 2029 option counterparty.
Our exposure will depend on many factors but, in general, an increase in our exposure will be correlated to an increase in the market price and volatility of our common stock.
−Removed: In addition, upon a default by an option counterparty, we may suffer more dilution than we currently anticipate with respect to our common stock.
+Added: In addition, upon a default by a 2029 option counterparty, we may suffer more dilution than we currently anticipate with respect to our common stock.
Risks Related to Our Future Financings and Financial Results
We may need or otherwise determine to raise additional funds in the future and if we are unable to raise additional funds when necessary or desirable, we may not be able to achieve our strategic objectives.*
−Removed: As of March 31, 2025, we had $368.6 million in cash, cash equivalents and short-term investments.
+Added: As of June 30, 2025, we had $315.4 million in cash, cash equivalents and short-term investments.
Our management expects the continued growth of our business, including the expansion of our customer service infrastructure to support our growing base of customers, our plans to continue expanding commercial sales of our products outside of the United States, the growth of our manufacturing and warehousing operations, and the increase of our facility footprint to accommodate additional headcount and R&D activities, will continue to increase our expenses.
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• the pricing of our products and competing products, including the use of discounts, rebates or other financial incentives by us or our competitors;
−Removed: • the effect of third-party coverage and reimbursement policies;
+Added: • the effect of third-party coverage and reimbursement policies, including any changes by CMS to reimbursement rates and payment schedule through a proposed competitive bidding process insulin pumps;
• our ability to maintain our existing infrastructure;
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Activities outside the United States accounted for approximately 28% of our total sales during 2024.
−Removed: Foreign currency fluctuations could result in volatility of our revenue.
+Added: Foreign currency fluctuations could result in volatility of our revenue and expenses.
In addition, we are exposed to transaction risk because we incur some of our sales and expenses in currencies other than the U.S.
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dollar may fluctuate substantially.
−Removed: We do not actively hedge our exposure to currency rate fluctuations.
The strengthening of the U.S.
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Inflation could also make our products more expensive and increase the credit risks to which we are exposed.
−Removed: Future foreign currency fluctuations could favorably or unfavorably impact and increase the volatility of our revenue, profitability, and stock price.
+Added: In 2025, we began actively hedging our exposure to currency rate fluctuations;
+Added: however, future foreign currency fluctuations are difficult to predict and there is no guaranty that our foreign currency hedging transactions will have the desired effect.
+Added: As a result of these hedging transactions and future foreign currency fluctuations, the volatility of our revenue, profitability, and stock price could increase and be favorably or unfavorably impacted.
These and other risks may have a material adverse effect on our business, financial condition and results of operations as a whole.
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We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.
−Removed: Our sensitive information could be leaked, disclosed, or revealed as a result of or in connection with our employees’, personnel’s, or third parties with whom we work use of generative artificial intelligence (AI) or machine learning (ML) technologies (collectively, AI/ML technologies).
+Added: Our sensitive information could be leaked, disclosed, or revealed as a result of or in connection with our employees’, personnel’s, or third parties with whom we work using generative artificial intelligence (AI) or machine learning (ML) technologies (collectively, AI/ML technologies).
Any sensitive information, including confidential, competitive, proprietary, or personal data, that we input into a third-party generative AI platform could be leaked or disclosed to others, including if sensitive information is used to train the third parties’ AI model.
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• pay substantial damages to the party whose intellectual property rights we are allegedly infringing.
−Removed: For example, November 2023, at the Unified Patent Court (UPC), Paris Central Division (UPC Paris), we filed a revocation action and an action for a declaration of non-infringement of EP Patent No.
−Removed: 2 196 231 B1 (the ’231 patent) against Roche Diabetes Care GmbH.
−Removed: While Roche contends that Tandem’s t:slim X2 pump infringes the ‘231 patent, we contend that our t:slim X2 pump does not infringe the ‘231 patent.
−Removed: Furthermore, we contend that the claims of the ‘231 patent are invalid over the prior art and should be revoked.
−Removed: In February 2024, Roche filed an infringement action against Tandem and its distributor in Germany at the UPC, Hamburg Local Division (UPC Hamburg) contending that Tandem’s t:slim X2 pump, and the offering, marketing, using, importing, possessing, and supplying of such devices infringes certain claims of the ‘231 patent.
−Removed: Roche seeks, among other things, damages and other monetary relief, costs and expenses of the legal proceedings, and an order to cease and desist the allegedly infringing activities.
−Removed: At the UPC Hamburg, Tandem has asserted that the t:slim X2 pump does not infringe the claims of the ‘231 patent and Tandem’s distributor has asserted that the t:slim X2 pump does not infringe the claims of the ‘231 patent and that the claims of the ‘231 patent are invalid and should be revoked.
−Removed: On November 6, 2024, the UPC Paris held a hearing on Tandem’s action to revoke the claims of the ‘231 patent.
−Removed: On December 18, 2024, the UPC Paris upheld the patent.
−Removed: The hearing in Hamburg on invalidity and non-infringement is scheduled for June 12, 2025.
−Removed: In December 2023, F.
−Removed: Hoffman-La Roche AG and Roche Diabetes Care GmbH (collectively, Roche), filed an infringement action at the UPC, Dusseldorf Division (UPC Dusseldorf) against Tandem Diabetes Care, Inc.
−Removed: and Tandem Diabetes Care Europe B.V.
−Removed: and Tandem’s distributors in Germany, France, the Netherlands and Denmark.
−Removed: Roche alleges our t:slim X2 insulin pump, and the offering, marketing, using, importing, possessing, and supplying of such devices infringe EP Patent No.
−Removed: 1 970 677 B1 (the ‘677 patent).
−Removed: While Roche contends that Tandem’s t:slim X2 pump infringes the ‘677 patent, we contend that our t:slim X2 pump does not infringe the ‘677 patent.
−Removed: Furthermore, we contend that the claims of the ‘677 patent are invalid over the prior art and should be revoked.
−Removed: Roche seeks, among other things, damages and other monetary relief, costs and expenses of the legal proceedings, and an order to cease and desist the allegedly infringing activities.
−Removed: On April 9, 2025, the UPC Dusseldorf held a hearing on Roche’s action asserting infringement of the ‘677 patent, Tandem and its distributors’ counterclaims that the t:slim X2 pump does not infringe the ‘677 patent, and Tandem and its distributors’ actions to revoke the claims of the ‘677 patent.
−Removed: The UPC Dusseldorf is expected to issue a ruling on May 22, 2025.
−Removed: As the UPC is a new court system that came into effect in 2023, enforcement and litigation under the UPC is new and we cannot accurately predict the outcome of such proceedings.
−Removed: If any of our products are found to infringe Roche’s patents and Roche’s patents are also found to be valid, we could be required to redesign our technology or obtain a license from Roche to continue importing, marketing and selling our dosing devices in certain countries in Europe.
−Removed: However, we may not be successful in the redesign of our technology or able to obtain any such license on commercially reasonable terms or at all.
−Removed: We also could be forced, including by court order, to cease importing, marketing and selling certain of our products in certain countries in Europe that are found to be infringing until the patents expire.
−Removed: Even if we were ultimately to prevail, litigation with Roche could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.
−Removed: We cannot reasonably estimate the final outcome, including any potential liability or any range of potential future charges associated with litigation.
+Added: For example, we were involved in a multi-year patent dispute with F.
+Added: Hoffman-La Roche AG and Roche Diabetes Care GmbH until our entry into a settlement agreement in May 2025.
+Added: See Note 14, “Commitments and Contingencies.”
We do not maintain insurance to cover the expense or any liability that may arise from an intellectual property dispute.
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Any of these sanctions could result in higher than anticipated costs, lower than anticipated sales, and diversion of management time and resources, any of which could have a material adverse effect on our reputation, business, financial condition and operating results.
−Removed: New products or modifications to our existing products may require new 510(k) clearances, PMAs or certifications, or may require us to cease marketing or recall the modified products until clearances, certifications or approvals are obtained.
+Added: New products or modifications to our existing products may require new 510(k) clearances, PMAs, CE Marks or other certifications, or may require us to cease marketing or recall the modified products until clearances, certifications or approvals are obtained.
Any modification to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design, or manufacture, requires a new 510(k) clearance or, possibly, a PMA.
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Reduced reimbursement rates could significantly decrease our revenue, which in turn would place significant downward pressure on our gross margins and impede our ability to become profitable.
−Removed: Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (the IRA 2022) into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in the Affordable Care Act marketplaces through plan year 2025.
+Added: Further, on August 16, 2022, former President Biden signed the Inflation Reduction Act of 2022 (the IRA 2022) into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in the Affordable Care Act marketplaces through plan year 2025.
The IRA 2022 also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program.
+Added: In addition, on July 4, 2025, the annual reconciliation bill, the “One Big Beautiful Bill Act” (“OBBBA”), was signed into law which is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.
+Added: OBBBA also narrows access to the Affordable Care Act marketplace exchange enrollment and declines to extend the Affordable Care Act enhanced advanced premium tax credits, set to expire in 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.
We cannot predict which, if any, additional healthcare reform proposals will be adopted, when they may be adopted or what impact they may have on the existing regulatory environment, or our ability to operate our business.
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Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.*
−Removed: Under current law, federal net operating losses (NOLs) incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal NOL carryforwards in a taxable year is limited to 80% of taxable income in such year.
+Added: Federal net operating losses (NOLs) incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal NOL carryforwards in a taxable year is limited to 80% of taxable income in such year.
As of December 31, 2024, we had accumulated federal and state NOL carryforwards of approximately $96.5 million, and $248.0 million, respectively.
−Removed: Of the total federal NOL carryforwards, approximately $13.2 million were generated after January 1, 2018, and therefore do not expire under current law but can only be utilized to offset 80% of future taxable income.
+Added: Of the total federal NOL carryforwards, approximately $13.2 million were generated after January 1, 2018, and therefore do not expire but can only be utilized to offset 80% of future taxable income.
The remaining federal NOL carryforwards of $83.2 million will begin to expire in 2033, and state tax loss carryforwards continue to expire.
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Similarly, a taxing authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a “permanent establishment” under international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions.
−Removed: Effective January 1, 2022, the Tax Cuts and Jobs Act of 2017 eliminated the option to deduct research and development expenses for tax purposes in the year incurred and requires taxpayers to capitalize and subsequently amortize such expenses over five years for research activities conducted in the United States and over 15 years for research activities conducted outside the United States.
−Removed: Although there have been legislative proposals to repeal or defer the capitalization requirement to later years, there can be no assurance that the provision will be repealed or otherwise modified.
−Removed: Future guidance from the Internal Revenue Service and other tax authorities with respect to such legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation.
+Added: government recently enacted the OBBBA that (along with other recent U.S.
+Added: federal tax reform) has resulted in significant changes to the taxation of business entities including, among other changes, changes to the taxation of income derived from international operations, changes in the deduction and amortization of research and development expenditures, and limitations on the deductibility of business interest.
+Added: Future guidance from the Internal Revenue Service and other tax authorities with respect to any legislation may affect us, and certain aspects of such legislation could be repealed or modified or sunset in future years.
Our tax obligations and effective tax rate in the jurisdictions in which we conduct business could increase, including as a result of the base erosion and profit shifting (BEPS) project led by the OECD and other initiatives led by the OECD or the European Commission.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.