64 unchanged sentences
Since our inception in January 2006, we have incurred a significant net loss.
−Removed: As of March 31, 2024, we had an accumulated deficit of $994.5 million.
+Added: As of June 30, 2024, we had an accumulated deficit of $1.0 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 financing.
318 unchanged sentences
Member State national legislation;
−Removed: • reduced protection for our intellectual property rights in certain countries outside the U.S.
−Removed: than exists in the U.S.;
+Added: • reduced protection for our intellectual property rights in certain countries outside the United States than exists in the United States;
• unexpected changes in tariffs, trade barriers and regulatory requirements;
43 unchanged sentences
Our operations and performance depend in part on worldwide economic and political conditions.
−Removed: Many of the jurisdictions in which our products are sold have experienced and could continue to experience unfavorable general economic conditions, such as a recession or economic slowdown, including as a result of political instability and military hostilities in certain geographies, concerns over the potential downgrade of U.S.
−Removed: sovereign debt and continued sovereign debt, monetary and financial uncertainties in Europe and other geographies, and domestic and global inflationary trends, any of which could negatively affect the affordability of, and consumer demand for, our products.
+Added: Many of the jurisdictions in which our products are sold have experienced and could continue to experience unfavorable general economic conditions, such as a recession or economic slowdown, including as a result of political instability and military hostilities in certain geographies, concerns over the potential downgrade of United States sovereign debt and continued sovereign debt, monetary and financial uncertainties in Europe and other geographies, and domestic and global inflationary trends, any of which could negatively affect the affordability of, and consumer demand for, our products.
Under difficult economic conditions, consumers may seek to modify spending priorities and reduce discretionary spending by delaying purchases of our products, which could reduce our profitability and could negatively affect our overall financial performance.
13 unchanged sentences
Climate change or other extreme weather conditions and related regulations may have a long-term impact on our business.
−Removed: Climate-related events, including the increasing frequency of extreme weather events and their impact on the U.S., Mexico, Canada, and other major regions’ critical infrastructure along with potential related regulations, have the potential to disrupt our business, our third-party suppliers, and/or the business of our customers.
+Added: Climate-related events, including the increasing frequency of extreme weather events and their impact on the United States, Mexico, Canada, and other major regions’ critical infrastructure along with potential related regulations, have the potential to disrupt our business, our third-party suppliers, and/or the business of our customers.
For example, our third-party contract manufacturers are located in regions subject to natural disasters, including earthquakes, hurricanes, floods, fires and other catastrophic events.
5 unchanged sentences
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, 2024, we had $467.8 million in cash, cash equivalents and short-term investments.
+Added: As of June 30, 2024, we had $452.4 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.
36 unchanged sentences
Risks Related to Privacy and Security
−Removed: We may be subject to stringent and evolving U.S.
−Removed: and foreign laws, regulations, and rules, contractual obligations, policies and other obligations related to data privacy and security.
+Added: We may be 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;
9 unchanged sentences
There are a number of laws in the United States governing the privacy and security of personal data, including data breach notification laws, data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws at the federal and state levels (e.g., wiretapping laws).
−Removed: For example, the U.S.
−Removed: Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), imposes specific requirements relating to the privacy of protected health information.
+Added: For example, the United States Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), imposes specific requirements relating to the privacy of protected health information.
As another example, the Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003 ("CAN-SPAM”) and the Telephone Consumer Protection Act of 1991 (“TCPA”) impose specific requirements on communications with customers.
2 unchanged sentences
dollars per violation imposed through private litigation or by state authorities.
−Removed: In recent years, numerous U.S.
−Removed: states—including California, Virginia, Colorado, Connecticut, and Utah—have enacted comprehensive data privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data.
+Added: In recent years, numerous United States states—including California, Virginia, Colorado, Connecticut, and Utah—have enacted comprehensive data privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data.
As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making.
13 unchanged sentences
Additionally, regulators are increasingly scrutinizing companies that process children’s data.
−Removed: Numerous laws, regulations, and legally-binding codes, such as the Children’s Online Privacy Protection Act (“COPPA”), California’s Age Appropriate Design Code (effective in July 2024), the CCPA, other U.S.
−Removed: state comprehensive data privacy laws, the GDPR, and the UK Age Appropriate Design Code, impose various obligations on companies that process children data, including requiring certain consents to process such data and extending certain rights to children and their parents with respect to that personal data.
+Added: Numerous laws, regulations, and legally-binding codes, such as the Children’s Online Privacy Protection Act (“COPPA”), California’s Age Appropriate Design Code (effective in July 2024), the CCPA, other United States state comprehensive data privacy laws, the GDPR, and the UK Age Appropriate Design Code, impose various obligations on companies that process children data, including requiring certain consents to process such data and extending certain rights to children and their parents with respect to that personal data.
Some of these obligations have wide ranging applications, including for services that do not intentionally target child users (defined in some circumstances as a user under the age of 18 years old).
105 unchanged sentences
Certain data privacy and security obligations may require us to implement and maintain reasonable or specific security measures or industry standards to protect our information technology systems and sensitive information.
−Removed: Applicable data privacy and security obligations may require us to notify relevant stakeholders, including affected individuals, customers, regulators, and investors, of security incidents.
−Removed: Such disclosures are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.
+Added: Applicable data privacy and security obligations may require us, or we may voluntarily choose, to notify relevant stakeholders, including affected individuals, customers, regulators, and investors, of security incidents, or to take other actions, such as providing credit monitoring and identify theft protection services.
+Added: Such disclosures and related actions can be costly, and the disclosure or the failure to comply with applicable requirements could lead to adverse consequences.
+Added: It may be difficult and/or costly to detect, investigate, mitigate, contain, and remediate a security incident.
Whether a security incident is reportable to our investors may not be straightforward, may take considerable time to determine, and may be subject to change as the investigation of the incident progresses, including changes that may significantly alter any initial disclosure that we provide.
+Added: Our efforts to investigate, mitigate, contain, and remediate a security incident may not be successful.
+Added: Actions taken by us or the third parties with whom we work to detect, investigate, mitigate, contain, and remediate a security incident could result in outages, data losses, and disruptions of our business.
+Added: Threat actors may also gain access to other networks and systems after a compromise of our networks and systems.
If we (or a third party with whom we work) experience a security incident (such as the phishing attack we experienced in 2020) or are perceived to have experienced a security incident, we may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections);
20 unchanged sentences
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.
−Removed: Additionally, where AI/ML technologies ingests personal data and makes connections using such data, those technologies may reveal other personal or sensitive information generated by the model.
+Added: Additionally, where AI/ML technologies ingest personal data and makes connections using such data, those technologies may reveal other personal or sensitive information generated by the model.
Moreover, AI models may create flawed, incomplete, or inaccurate outputs, some of which may appear correct.
52 unchanged sentences
2 196 231 B1 (the “’231 patent”) against Roche Diabetes Care GmbH.
−Removed: While Roche contends that Tandem’s t:slim X2 pump infringes on the ‘231 patent, we contend that our t:slim X2 pump does not practice the ‘231 patent.
−Removed: Furthermore, we contend that the claims of the ‘231 patent are invalid over the prior art.
−Removed: In February 2024, Roche filed an infringement action against Tandem and one of its distributors at the UPC contending that Tandem’s t:slim X2 pump infringes on the ‘231 patent.
+Added: 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.
+Added: Furthermore, we contend that the claims of the ‘231 patent are invalid over the prior art and should be revoked.
+Added: In February 2024, Roche filed an infringement action against Tandem and one of its distributors at the UPC contending that Tandem’s t:slim X2 pump infringes the ‘231 patent.
+Added: On November 6, 2024, the UPC (Paris Central Division) will hold a hearing on Tandem’s motion to revoke the claims of the ‘231 patent.
In December 2023, F.
36 unchanged sentences
Regulatory restrictions or changes could limit our ability to carry on or expand our operations or result in higher than anticipated costs or lower than anticipated sales.
−Removed: The FDA and other U.S.
−Removed: governmental agencies and comparable foreign regulatory authorities and Notified Bodies regulate numerous elements of our business, including:
+Added: The FDA and other United States governmental agencies and comparable foreign regulatory authorities and Notified Bodies regulate numerous elements of our business, including:
• product design and development;
48 unchanged sentences
Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension, variation or withdrawal of CE Certificates of Conformity, product seizures, injunctions or the imposition of civil or criminal penalties that would adversely affect our business, operating results and prospects.
−Removed: Our failure to comply with U.S.
−Removed: federal and state fraud and abuse laws, including anti-kickback laws and other U.S.
−Removed: federal and state anti-referral laws, or comparable foreign legislation, could have a material, adverse impact on our business.*
−Removed: has numerous federal and state laws pertaining to healthcare fraud and abuse.
+Added: 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.*
+Added: The United States has numerous federal and state laws pertaining to healthcare fraud and abuse.
Violations of these laws are punishable by criminal and civil sanctions, including, imprisonment, significant monetary penalties and exclusion from participation in federal funded programs such as Medicare and Medicaid.
9 unchanged sentences
• federal and state laws governing the use, disclosure and security of personal information, including protected health information, such as HIPAA and the HITECH;
−Removed: • foreign and U.S.
−Removed: state law equivalents of each of the above federal laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
+Added: • foreign and United States state law equivalents of each of the above federal laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
Outside the United States, interactions between medical device companies and healthcare professionals are also governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.
5 unchanged sentences
We cannot predict the impact of any changes in these laws and whether they might be retroactive.
−Removed: Further, the U.S.
−Removed: Department of Justice (DOJ) in conjunction with other federal agencies, has increased its scrutiny of interactions between healthcare companies and healthcare providers.
+Added: Further, the United States Department of Justice (DOJ) in conjunction with other federal agencies, has increased its scrutiny of interactions between healthcare companies and healthcare providers.
Adjusting to new regulatory guidelines and responding to investigations can be time and resource-consuming and can divert management’s attention from our core business.
90 unchanged sentences
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 NOLs is limited to 80% of taxable income.
−Removed: It is uncertain if and to what extent various states will conform to federal tax laws.
As of December 31, 2023, we had accumulated federal and state NOL carryforwards of approximately $168.0 million, and $262.4 million, respectively.
3 unchanged sentences
federal income taxes to be paid earlier than would be paid if such limitations were not in effect and could cause NOL carryforwards to expire unused.
+Added: Similar rules may apply under state tax laws.
+Added: In addition, there may be other limitations under state law on our ability to utilize NOLs, including temporary suspensions or other limitations on the use of NOLs to offset taxable income.
We believe we experienced at least one ownership change that significantly reduced our ability to utilize our pre-2018 NOL and research credit carryforwards before they expire.
2 unchanged sentences
The tax regimes to which we are subject or under which we operate are unsettled and may be subject to significant change.
−Removed: The issuance of additional guidance related to existing or future tax laws, or changes to tax laws or regulations proposed or implemented by the current or a future U.S.
−Removed: presidential administration, Congress, or taxing authorities in other jurisdictions, including jurisdictions outside of the United States, could materially affect our tax obligations and effective tax rate.
+Added: The issuance of additional guidance related to existing or future tax laws, or changes to tax laws or regulations proposed or implemented by the current or a future United States presidential administration, Congress, or taxing authorities in other jurisdictions, including jurisdictions outside of the United States, could materially affect our tax obligations and effective tax rate.
To the extent that such changes have a negative impact on us, including as a result of related uncertainty, these changes may adversely impact our business, financial condition, results of operations, and cash flows.
28 unchanged sentences
In March 2024, we completed the offering of $316.25 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, 2024, we had approximately $40.8 million aggregate principal amount of the 2025 Notes outstanding.
+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 as of June 30, 2024, we had approximately $40.8 million aggregate principal amount of the 2025 Notes outstanding.
The Notes are our senior unsecured obligations, and interest on the Notes is payable in cash semi-annually at a rate of 1.50% per year.
47 unchanged sentences
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: Unregistered Sales of Equity Securities and Use of Proceeds.
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.