Tandem Diabetes Care, Inc. is an American medical-device company that develops and markets insulin pumps, automated insulin delivery systems and diabetes-management software. Headquartered in San Diego, California, its principal pump platforms are the t:slim X2 and Tandem Mobi, both of which use the company's Control-IQ+ software with compatible continuous glucose monitors (CGMs). Tandem was founded in 2006 and introduced its first pump, the touchscreen t:slim, in 2012.3 Its shares trade on Nasdaq under the symbol TNDM.1Wikipedia text CC BY-SA 4.0
Tandem Diabetes Care, Inc. is an American medical-device company that develops and markets insulin pumps, automated insulin delivery systems and diabetes-management software. Headquartered in San Diego, California, its principal pump platforms are the t:slim X2 and Tandem Mobi, both of which use the company's Control-IQ+ software with compatible continuous glucose monitors (CGMs).3
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Outside the United States$307.8M930%up 15% from 2024
Regions by year
Regions
2023
2024
2025
United States
$554.9M
$672.7M
$706.9M
Outside the United States
$192.8M
$267.5M
$307.8M
Where the money goes
Where each dollar of revenue went, fiscal 2025
Cost of revenueSelling, general and admin
Cost of revenue46¢$468.7M
Selling, general and admin44¢$445.0M
Other costs10¢$96.6M
Income tax0¢$4.4M
Out of $1.0B in revenue.9 The company lost money this year.
Financial statements
Revenue101112139$1.0B in 2025+180% since 2019Gross profit101112139$546.0M in 2025+181% since 2019Operating income101112139-$187.3M in 2025+1020% since 2019Net income101112139-$204.7M in 2025+727% since 2019
Revenue91415$254.6M in Q2 FY2026−12% since Q4 FY2025Gross profit91415$144.8M in Q2 FY2026−14% since Q4 FY2025Operating income91415-$13.8M in Q2 FY2026Net income91415-$21.2M in Q2 FY2026+3494% since Q4 FY2025
Every line of the income statement as filed: the last 3 fiscal years (annual) or 2 quarters (quarterly), latest first.9
Period ending
2025-12-31
2024-12-31
2023-12-31
Sales
$1.0B
$940.2M
$747.7M
Cost of sales
$468.7M
$450.6M
$380.0M
Gross profit
$546.0M
$489.6M
$367.7M
Selling, general and administrative
$445.0M
$389.8M
$352.5M
Research and development
$193.1M
$198.9M
$169.7M
Acquired in-process research and development expenses
$75.2M
$0
$78.8M
Litigation and settlement expense
$20.0M
$0
$0
Total operating expenses
$733.3M
$588.7M
$600.9M
Operating loss
-$187.3M
-$99.1M
-$233.2M
Interest income and other income, net
$9.1M
$18.0M
$22.9M
Interest expense
-$7.9M
-$7.4M
-$9.9M
Loss from equity method investments
-$14.2M
-$2.1M
$0
Loss on extinguishment of debt
$0
-$1.3M
$0
Total other income (expense), net
-$13.0M
$7.3M
$13.0M
Loss before income taxes
-$200.3M
-$91.9M
-$220.3M
Income tax expense
$4.4M
$4.2M
$2.4M
Net loss
-$204.7M
-$96.0M
-$222.6M
Unrealized gain (loss) on short-term investments
$517.0K
-$311.0K
$3.6M
Unrealized loss on cash flow hedges
-$312.0K
$0
$0
Foreign currency translation gains (losses)
$7.3M
-$3.0M
-$420.0K
Comprehensive loss
-$197.2M
-$99.3M
-$219.4M
Net loss per share - basic (in dollars per share)
-$3.04
-$1.47
-$3.43
Net loss per share - diluted (in dollars per share)
-$3.04
-$1.47
-$3.43
Weighted average shares used to compute basic net loss per share (in shares)
67.3M shares
65.5M shares
65.0M shares
Weighted average shares used to compute diluted net loss per share (in shares)
67.3M shares
65.5M shares
65.0M shares
Period ending
2025-12-31
2024-12-31
Sales
$290.4M
$282.6M
Gross profit
$167.5M
$157.5M
Total operating expenses
$159.2M
$158.0M
Operating loss
$8.3M
-$581.0K
Net loss
-$589.0K
$755.0K
Net loss per share - basic (in dollars per share)
-$0.01
$0.01
Net loss per share - diluted (in dollars per share)
-$0.01
$0.01
Weighted average shares used to compute basic net loss per share (in shares)
68.0M shares
65.9M shares
Weighted average shares used to compute diluted net loss per share (in shares)
68.0M shares
66.2M shares
Total assets16101112139$881.1M in 2025+170% since 2019Total liabilities16101112139$725.9M in 2025+454% since 2019Shareholders’ equity1112139$155.2M in 2025−20% since 2019Cash16101112139$90.6M in 2025+77% since 2019Long-term debt139$310.0M in 2025+9% since 2023
Total assets1415$1.2B in Q2 FY2026+31% since Q1 FY2025Total liabilities1415$1.0B in Q2 FY2026+41% since Q1 FY2025Shareholders’ equity1415$130.4M in Q2 FY2026−16% since Q1 FY2025Cash1415$62.8M in Q2 FY2026−31% since Q1 FY2025Long-term debt1415$602.6M in Q2 FY2026+94% since Q1 FY2025
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.9
Period ending
2025-12-31
2024-12-31
2023-12-31
2022-12-31
Cash and cash equivalents
$90.6M
$69.2M
Short-term investments
$202.0M
$369.1M
Accounts receivable, net
$165.5M
$114.6M
Inventories
$128.8M
$149.6M
Prepaid and other current assets
$31.2M
$22.0M
Total current assets
$618.1M
$724.5M
Property and equipment, net
$83.6M
$78.2M
Operating lease right-of-use assets
$96.2M
$85.3M
Equity method investments
$60.4M
$74.5M
Other long-term assets
$22.9M
$5.2M
Total assets
$881.1M
$967.7M
Accounts payable
$47.1M
$44.7M
Accrued expenses
$21.0M
$18.2M
Employee-related liabilities
$70.4M
$64.1M
Current portion of convertible senior notes, net
$0
$40.7M
Operating lease liabilities
$19.5M
$18.2M
Deferred revenue
$9.5M
$11.8M
Other current liabilities
$75.2M
$49.3M
Total current liabilities
$242.7M
$247.0M
Convertible senior notes, net - long-term
$310.0M
$308.3M
Operating lease liabilities - long-term
$115.0M
$106.4M
Deferred revenue - long-term
$8.5M
$10.5M
Other long-term liabilities
$49.7M
$32.4M
Total liabilities
$725.9M
$704.6M
Commitments and contingencies (Note 14)
$0
$0
Common stock, $0.001 par value; 200,000 shares authorized, 68,291 and 66,264 shares issued and outstanding as of December 31, 2025 and 2024, respectively
$68.0K
$66.0K
Additional paid-in capital
$1.4B
$1.3B
Accumulated other comprehensive income (loss)
$5.6M
-$1.9M
Accumulated deficit
-$1.3B
-$1.0B
Total stockholders equity
$155.2M
$263.1M
$313.6M
$439.9M
Total liabilities and stockholders equity
$881.1M
$967.7M
Common stock, par value (in dollars per share)
$0.00
$0.00
Common stock, shares authorized (in shares)
200.0M shares
200.0M shares
Common stock, shares issued (in shares)
68.3M shares
66.3M shares
Common stock, shares outstanding (in shares)
68.3M shares
66.3M shares
Period ending
2025-12-31
2024-12-31
2023-12-31
2022-12-31
Cash and cash equivalents
$90.6M
$69.2M
Short-term investments
$202.0M
$369.1M
Accounts receivable, net
$165.5M
$114.6M
Inventories
$128.8M
$149.6M
Prepaid and other current assets
$31.2M
$22.0M
Total current assets
$618.1M
$724.5M
Property and equipment, net
$83.6M
$78.2M
Operating lease right-of-use assets
$96.2M
$85.3M
Equity method investments
$60.4M
$74.5M
Other long-term assets
$22.9M
$5.2M
Total assets
$881.1M
$967.7M
Accounts payable
$47.1M
$44.7M
Accrued expenses
$21.0M
$18.2M
Employee-related liabilities
$70.4M
$64.1M
Current portion of convertible senior notes, net
$0
$40.7M
Operating lease liabilities
$19.5M
$18.2M
Deferred revenue
$9.5M
$11.8M
Other current liabilities
$75.2M
$49.3M
Total current liabilities
$242.7M
$247.0M
Convertible senior notes, net - long-term
$310.0M
$308.3M
Operating lease liabilities - long-term
$115.0M
$106.4M
Deferred revenue - long-term
$8.5M
$10.5M
Other long-term liabilities
$49.7M
$32.4M
Total liabilities
$725.9M
$704.6M
Commitments and contingencies (Note 14)
$0
$0
Common stock, $0.001 par value; 200,000 shares authorized, 68,291 and 66,264 shares issued and outstanding as of December 31, 2025 and 2024, respectively
$68.0K
$66.0K
Additional paid-in capital
$1.4B
$1.3B
Accumulated other comprehensive income (loss)
$5.6M
-$1.9M
Accumulated deficit
-$1.3B
-$1.0B
Total stockholders equity
$155.2M
$263.1M
$313.6M
$439.9M
Total liabilities and stockholders equity
$881.1M
$967.7M
Common stock, par value (in dollars per share)
$0.00
$0.00
Common stock, shares authorized (in shares)
200.0M shares
200.0M shares
Common stock, shares issued (in shares)
68.3M shares
66.3M shares
Common stock, shares outstanding (in shares)
68.3M shares
66.3M shares
Cash from operations101112139-$9.7M in 2025Capital spending101112139$19.9M in 2025+2% since 2019Free cash flow101112139-$29.7M in 2025Share buybacks139$0 in 2025
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 3 fiscal years, latest first.9
Period ending
2025-12-31
2024-12-31
2023-12-31
Net loss
-$204.7M
-$96.0M
-$222.6M
Depreciation and amortization expense
$17.7M
$16.6M
$15.7M
Amortization of debt issuance costs
$1.9M
$2.1M
$2.2M
Provision for expected credit losses
$9.5M
$10.0M
$5.5M
Operating lease and other impairment charges
$6.7M
$2.0M
$14.1M
Amortization of discount or (accretion of premium) on short-term investments
-$3.8M
-$2.3M
$3.6M
Loss from equity method investments
$14.2M
$2.1M
$0
Stock-based compensation expense
$92.4M
$101.4M
$88.1M
Loss on extinguishment of debt
$0
$1.3M
$0
Acquired in-process research and development expenses
$75.2M
$0
$78.8M
Other
$4.4M
-$1.0M
$515.0K
Accounts receivable, net
-$56.8M
-$20.8M
$4.3M
Inventories
$24.8M
$5.8M
-$46.1M
Prepaid and other current assets
-$9.1M
-$5.6M
-$9.1M
Other long-term assets
-$6.9M
$893.0K
-$3.2M
Accounts payable
$2.2M
-$2.4M
-$4.9M
Accrued expenses
-$664.0K
$5.5M
$2.5M
Employee-related liabilities
$6.0M
$20.9M
$5.2M
Deferred revenue
-$4.8M
-$34.7M
$21.5M
Operating leases and other current liabilities
$19.2M
$17.6M
$4.3M
Other long-term liabilities
$2.9M
$998.0K
$7.8M
Net cash provided by (used in) operating activities
-$9.7M
$24.2M
-$31.8M
Purchases of short-term investments
-$85.7M
-$264.3M
-$510.9M
Proceeds from maturities and redemptions of short-term investments
$257.1M
$306.5M
$546.2M
Purchases of property and equipment
-$19.9M
-$19.2M
-$26.8M
Acquisition of in-process research and development
-$78.6M
$0
-$69.5M
Purchases of equity investments, strategic investments, and intangible assets
$0
-$46.4M
-$24.8M
Net cash provided by (used in) investing activities
$72.9M
-$23.5M
-$85.7M
Proceeds from issuance of convertible senior notes due 2029, net of $9,400 debt issuance costs
$0
$306.9M
$0
Repurchase of $246,740 principal amount of convertible senior notes due 2025
$0
-$246.1M
$0
Principal payments on convertible senior notes due 2025
-$40.8M
$0
Payment for capped call transactions related to convertible senior notes due 2029
$0
-$15.8M
$0
Repurchase and retirement of common stock
$0
-$30.0M
$0
Cash used to settle withholding taxes on vested restricted stock, net of proceeds from issuance of common stock under Company stock plans
-$2.6M
-$6.7M
$4.2M
Other financing activities
$0
$183.0K
-$71.0K
Net cash provided by (used in) financing activities
-$43.4M
$8.4M
$4.1M
Effect of foreign exchange rate changes on cash
$1.6M
$1.3M
-$212.0K
Net increase (decrease) in cash and cash equivalents
$21.4M
$10.4M
-$113.6M
Interest paid
$5.0M
$3.1M
$7.6M
Income taxes paid
$5.1M
$3.1M
$1.9M
Operating lease right-of-use assets obtained in exchange for operating lease obligations
$26.2M
$4.4M
$0
Purchases of property and equipment included in accounts payable and accrued expenses
Tandem Diabetes Care, Inc. sits at the top of its group. 9 entities, 7 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Tandem Diabetes Care, Inc.
Voya FinancialFiled SCHEDULE 13G/A on Tandem Diabetes Care, Inc., latest Aug 6, 2026 (2 filings since May 5, 2026)
Tandem Diabetes Care, Inc.Wilmington, Delaware, United States
Tandem Diabetes Care Canada, Inc. Subsidiary · Canada
Tandem Diabetes Care Europe B.V. Subsidiary · Netherlands
Tandem Diabetes Care International Sarl Subsidiary · Switzerland
Tandem Diabetes France SAS Subsidiary · France
Tandem Diabetes International Holdings B.V. Subsidiary · Netherlands
Tandem Diabetes UK Limited Subsidiary · United Kingdom
Tandem Germany GmbH Subsidiary · Germany
TandTandem Diabetes Care Switzerland Sarl Subsidiary · Switzerland
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Tandem Diabetes Care, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Our corporate headquarters and principal offices are located at a 181,949 square foot facility we lease in San Diego, California. The initial lease term expires in April 2035, and we have two options to extend the lease for additional five-year periods as well as a right of first offer with respect to an additional 16,154 square feet of general office space should the space become available. We lease additional office space in San Diego, California, primarily for research and development activities. We also lease office space in four countries internationally to facilitate operations.
We believe that the facilities that we presently occupy will be sufficient to support our current operations and that suitable additional facilities would be available to us should our operations require it.
The company was incorporated in January 2006 as Phluid, Inc. and changed its name to Tandem Diabetes Care in 2008. Former Biosite executive Kim Blickenstaff joined as president and chief executive officer in 2007. Its first product was designed following interviews with pump users and clinicians and used a color touchscreen rather than the button-based interfaces then common on insulin pumps.
The Food and Drug Administration (FDA) cleared the t:slim insulin-delivery system in November 2011, and Tandem began selling it in the United States the following year. In November 2013, Tandem sold eight million shares at $15 each in its initial public offering, raising approximately $108 million after costs.
Tandem began shipping the software-updatable t:slim X2 in 2016. The FDA subsequently authorized versions that displayed readings from the Dexcom G5 and G6 CGMs, and in 2019 classified the t:slim X2 as the first alternate controller enabled insulin pump, a category designed to support interoperable diabetes devices. John Sheridan, previously the company's chief operating officer, succeeded Blickenstaff as president and CEO in March 2019.
The company acquired the diabetes-data application Sugarmate in June 2020. It acquired infusion-set developer Capillary Biomedical for $24.7 million in July 2022 and Swiss patch-pump developer AMF Medical in January 2023. AMF had been developing Sigi, a rechargeable patch pump that used prefilled insulin cartridges; the product remained in development at the end of 2025.
The t:slim X2 is a rechargeable, touchscreen insulin pump with a 300-unit cartridge. It delivers programmed basal and bolus insulin through an infusion set and can receive software updates without replacement of the pump hardware. When used with a compatible CGM and Control-IQ technology, it can automatically adjust insulin delivery. The platform has supported integrations with Dexcom and FreeStyle Libre sensors in different markets.
The t:slim line replaced Tandem's earlier t:flex and t:slim G4 models. The t:slim G4, approved in 2015, combined a Tandem pump with the Dexcom G4 Platinum CGM display.
Tandem Mobi
The Tandem Mobi is a smaller durable pump intended to be worn on the body or carried in clothing. It uses a 200-unit cartridge and is operated principally from a compatible smartphone app, while a physical button can deliver a preset bolus. The FDA cleared the pump in July 2023, and Tandem began its full United States launch in February 2024. The company obtained a CE mark for Mobi in 2025 and subsequently began introducing it in European markets.
Automated insulin delivery
Tandem introduced Basal-IQ in 2018. The feature used predicted CGM values to suspend insulin delivery when glucose was expected to become low and resumed delivery when values recovered.
Read the full text
Control-IQ is a hybrid closed-loop system that uses CGM readings and a model-predictive algorithm to increase, decrease or suspend basal insulin and to deliver automatic correction boluses. Users still program personal therapy settings and normally announce meals. The FDA authorized Control-IQ through the De Novo pathway in December 2019, creating a regulatory category for interoperable automated glycemic controllers. Tandem launched it in the United States in January 2020 as a software update for compatible t:slim X2 pumps.
A revised version, Control-IQ+, broadened supported therapy settings and was cleared in 2025 for adults with type 2 diabetes who require insulin. In the United States, Control-IQ+ is used on both the t:slim X2 and Mobi platforms.
Data applications
The FDA cleared Tandem's t:connect desktop data-management application in 2013. A later mobile version displays pump and CGM information and, on compatible systems, permits bolus delivery from a phone. Tandem Source, introduced in the United States in 2023, is a web platform through which users and clinicians review therapy data. Sugarmate is a separate application for viewing CGM data and receiving customizable alerts.
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
532 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 47 major events, 395 insider forms, 32 large holders, 38 other. The latest 20:
52 open-market trades by officers, directors and large owners since October 2021: 15 buys and 37 sales. Grants, option exercises and gifts are left out.
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.
Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).
SEC filer profile
How Tandem Diabetes Care, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
From the cover page of the 10-K filed Feb 19, 2026 (Section 12(b) of the Exchange Act).17
Risk factors and legal proceedings
The risks Tandem Diabetes Care, Inc. names in Item 1A of its 10-K filed Feb 19, 2026: 63 risks under these headings, as written.17
Risks Related to Our Business and Our Industry
We have incurred significant operating losses since inception and cannot assure you that we will achieve sustained profitability.
We currently rely on sales of insulin pump products to generate a significant portion of our sales, and any factors that negatively impact sales of these products may adversely affect our business, financial condition and operating results.
We are implementing a multi-channel managed care strategy in the United States that impacts the pricing model for our pumps and our supplies sold through the pharmacy channel. If our pharmacy channel strategy fails to achieve its intended outcome, our growth, business, results of operations, and financial condition could be materially and adversely impacted.
Our ability to maintain and grow our sales depends in part on retaining a high percentage of our customer base.
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.
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.
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 largely depend on independent distributors who are free to market products that compete with our products. If we are unable to maintain or expand our network of independent distributors, our sales may be negatively affected.
If the third parties on which we increasingly rely to assist us with our current and anticipated pre-clinical development or clinical trials do not perform as expected, we may not be able to obtain regulatory clearance, certification, or approval or commercialize our products.
We are dependent on clinical investigators and clinical sites to enroll participants in our current and anticipated clinical trials and human factors studies, and the failure to successfully complete those trials and studies could prevent us from obtaining regulatory clearances, certifications, or approvals for or commercializing our products.
The other 52 risks
If important assumptions about the potential market for our products are inaccurate, or if we have failed to understand what people with insulin-dependent diabetes are seeking in an insulin pump, our business and operating results may be adversely affected.
Any concerns regarding the safety and efficacy of our products could limit sales and cause unforeseen negative effects on our business prospects and financial results.
Our ability to achieve profitability will depend, in part, on our ability to reduce the per-unit cost of our products while also increasing production volume.
Manufacturing risks may adversely affect our ability to manufacture products, which could negatively impact our sales and operating margins.
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.
Any disruption at one of our facilities could adversely affect our business and operating results.
We may not experience the anticipated operating efficiencies of our manufacturing and warehousing operations.
We may enter into collaborations, licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future sales.
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.
Risks Related to Our International Operations
Commercializing our products internationally may result in a variety of risks associated with international operations that could materially adversely affect our business.
Failure to obtain any required regulatory authorization, clearance or certification in foreign jurisdictions will prevent us from marketing our products in international markets.
Failure to comply with the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws could materially adversely affect our business and result in civil and/or criminal sanctions.
Risks Related to Our Indebtedness
We have incurred a significant amount of indebtedness, and the agreements governing such indebtedness subject us to required debt service payments, which may restrict our financial flexibility and affect our ability to operate our business.
Servicing the 2029 Notes will require a significant amount of cash, and we may not have sufficient cash flow from our business to repay the 2029 Notes.
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.
Conversion of the 2029 Notes will, to the extent we deliver shares upon conversion of such 2029 Notes, dilute the ownership interest of existing stockholders and may otherwise have a negative impact on the trading price of our common stock.
Certain provisions in the indentures governing the 2029 Notes may delay or prevent an otherwise beneficial takeover attempt.
The Capped Call Transactions may affect the value of the 2029 Notes and our common stock.
We are subject to counterparty risk with respect to the 2029 Capped Call Transactions.
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.
Our operating results may fluctuate significantly from quarter to quarter.
Risks Related to Macroeconomic Conditions and External Factors
International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition and operating results.
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.
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.
The effects of inflation could adversely affect our business.
Risks Related to Privacy and Security
We are and may become subject to stringent and evolving United States and foreign laws, regulations, and rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of sales or profits; loss of customers; and other adverse business consequences.
If our information technology systems or those of third parties with whom we work, our data, or our software are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; harm to our reputation; loss of sales or profits; loss of customers; and other adverse consequences.
Cyberattacks aimed at our devices, products, services, or related systems, with the intent to alter or misuse them in ways that are inconsistent with our FDA clearances and approvals, could pose risks to users.
Risks Related to Legal and Intellectual Property
Our ability to comprehensively protect our intellectual property and proprietary technology is uncertain.
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.
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.
We may incur product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses.
Adhering to regulations concerning public company corporate governance and reporting requirements may place a strain on our resources and distract management from other priorities.
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.
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.
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.
Our failure to comply with United States federal and state fraud and abuse laws, including anti-kickback laws and other United States federal and state anti-referral laws, or comparable foreign legislation, could have a material, adverse impact on our business.
Legislative or regulatory healthcare reforms, or other regulatory reforms, may result in downward pressure on the price of and decrease reimbursement for our products, and uncertainty regarding the healthcare regulatory environment could have a material adverse effect on our business.
Governments internationally tend to impose strict price controls, reimbursement approval and rebate policies, which may adversely affect our ability to generate sales.
Our advertising and promotion may include claims about our product in comparison to competing products, which could expose us to heightened regulatory scrutiny, enforcement risks, and the potential for litigation.
Direct-to-consumer marketing and social media initiatives may subject us to increased regulatory scrutiny.
Risks Related to Environmental, Social and Governance Matters
Environmental, social, and governance (ESG) regulations, initiatives, directives, policies, and requirements could expose us to various risks.
Our business could be adversely affected by changing expectations and challenges associated with implementing ESG initiatives, establishing ESG-related goals, gathering ESG data, and disclosing ESG-related information.
Climate change or other extreme weather conditions and related regulations may have a long-term impact on our business.
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.
Anti-takeover provisions in our organizational documents and Delaware law may delay or prevent a change of control, which could reduce our stock price and prevent our stockholders from removing our current board of directors.
We may seek to grow our business through acquisitions of products or technologies, or investments in businesses, and the failure to successfully manage these acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on our business, financial condition and operating results.
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.
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.
Legal proceedings
There are no material pending legal proceedings to which we or any of our subsidiaries is a party or of which any of our property is subject.
