Senseonics Holdings, Inc.
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 5, 2025
SENS$8.59+7.5%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0001558370-25-010510
ITEM 1A. : Risk FactorsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001104659-25-107023
ITEM 1A. : Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 36 previous paragraphs and 43 current paragraphs.
17 unchanged; 11 reworded; 13 added; 7 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 28 previous and 28 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
The transition of commercial responsibility for Eversense to Senseonics is subject to the finalization and execution of a definitive agreement with Ascensia and, for certain European countries, an uncertain government approval process.
Current report
We recently entered into a memorandum of understanding (“MOU”) with Ascensia related to the termination of our existing Commercialization Agreement and the transfer of commercial responsibility for Eversense from Ascensia back to the Company. As contemplated by the MOU, we expect to resume responsibility for U.S. commercial activities beginning January 1, 2026 and, for non-U.S. jurisdictions, as soon as practicable thereafter. The MOU establishes the primary terms, including key financial terms, of the planned transition. However, the final terms of the definitive agreement with Ascensia remain under negotiation and the transition plans under joint development, with the final responsibility for various transition activities and liabilities still being determined. Therefore, we cannot predict with certainty the total costs that we will incur, or liabilities that we may assume, in connection with the commercial transition. If the final terms of the agreement are less favorable to us than we anticipate, it could have a material adverse effect on our ability to transition commercial responsibility for Eversense or our future results of operations.
Current report
The commercialization of Eversense in certain European countries is subject to government tender systems within the various countries. The ability of the Company to participate in the various tenders will require the satisfaction of the requirements of these countries’ regulatory bodies, and in some cases approval, which vary country by country and are further governed by specific regional level requirements within the countries. Although we are working with Ascensia and our advisors to understand these processes and the necessary requirements for each country, this process is inherently uncertain, as is the timing for receipt of any required approvals. As a result, the timeline for our eventual assumption of full commercial responsibilities in these countries is difficult to predict. Additionally, if one or more countries were to condition the transfer of a tender to the Company on terms that are less favorable than we expect, it could adversely affect the success of our European commercialization efforts.
Current report
Our resumption of commercial responsibility for Eversense will require us to develop a number of internal functions and may not be successful.
Current report
It has been more than five years since we had direct commercial responsibility for Eversense and, in order to resume commercial responsibility for the product, we will need to develop internal sales, marketing and distribution capabilities. This will require us to integrate, and in some cases, recruit, hire and train additional sales and dedicated marketing personnel, as well as other supportive functions. As a result, we expect our operating expenses to significantly increase as we resume commercial responsibility for Eversense. Although we expect to capture a larger portion of the revenue from Eversense sales following the transition, these revenue increases may not be sufficient to cover our increased operating expenses.
Current report
We have offered employment to many of the Ascensia personnel currently responsible for Eversense commercialization in the United States and plan to offer employment to additional European personnel after finalization of the definitive agreements with Ascensia and appropriate local labor law processes. However, we cannot guarantee you that we will be successful in transitioning all needed personnel to our Company or that we will not experience operational challenges and inefficiencies as we resume commercial responsibility for the product. Additionally, although we are working to transition the commercial responsibility of Eversense in a smooth manner, with minimal disruption to the supply of Eversense to patients, it is possible that health care providers, patients or tender authorities may have questions or concerns regarding the transition that could adversely affect demand for the product.
Current report
If we encounter any of the issues described above in the transition of commercial responsibility for Eversense back to the Company, it could have a material adverse effect on our business, prospects and results of operations.
Current report
We cannot predict the ultimate effect on our common stock share price of the one-for-twenty Reverse Stock Split of our common stock that was effected on October 17, 2025. The Reverse Stock Split may decrease the liquidity of our common stock and magnify any decrease in our overall market capitalization.
Current report
The ultimate effect of the Reverse Stock Split on the market price of our common stock cannot be predicted with any certainty, and we cannot assure you that the Reverse Stock Split will result in any or all of the benefits we expect. While we expect that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of our common stock, we cannot assure you that the Reverse Stock Split will increase the market price of our common stock by a multiple of the Reverse Stock Split ratio or result in any permanent or sustained increase in the market price of our common stock. The market price of our common stock depends on multiple factors, many of which are unrelated to the number of shares outstanding, including our business and financial performance, general market conditions and prospects for future success, any of which could have a counteracting effect to the Reverse Stock Split on the per share price.
Current report
In addition, the Reverse Stock Split also reduced the total number of outstanding shares of common stock, which may lead to reduced trading for our common stock. As a result of a lower number of shares outstanding, the market for our common stock may also become more volatile. The Reverse Stock Split also increased the number of stockholders who own “odd lots” of less than 100 shares of common stock. A purchase or sale of less than 100 shares of common stock (an “odd lot” transaction) may result in incrementally higher trading costs through certain brokers, particularly “full service” brokers. Therefore, those stockholders who own fewer than 100 shares of common stock following the Reverse Stock Split may be required to pay higher transaction costs if they sell their common stock.
Current report
There is uncertainty regarding our ability to maintain sufficient liquidity to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Current report
The financial statements in this report have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our management has concluded that the capital considerations required to assume Eversense commercialization and distribution responsibilities, our existing unrestricted cash and cash equivalents, and the minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under our Amended Loan and Security Agreement raise substantial doubts regarding our ability to continue as a going concern for the next twelve months after issuance of our the financial statements in this report.
Current report
As of September 30, 2025, the Company had unrestricted cash, cash equivalents and marketable securities of $111.0 million consisting of cash and investments in highly liquid U.S. money market funds. We do not expect our existing cash and cash equivalents will be sufficient to fund our operations, including the expanded operations that will be required to resume commercialization of Eversense, through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time. There can be no assurance that we will be successful in raising additional capital or that any needed financing will be available in the future at terms acceptable to us. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements are issued and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, and substantial doubt exists about our ability to continue as a going concern. If we are unable to secure additional capital on acceptable terms or at all, we may be required to significantly reduce or cease our operations, purse strategic alternatives, or consider other actions which could result in a loss to investors of their investment in our securities.
Removed paragraphs (7)
Previous report
Our Commercialization Agreement with Ascensia to market Eversense may not be successful.
Previous report
We have a Commercialization Agreement with Ascensia, pursuant to which we have granted Ascensia the exclusive right to distribute Eversense worldwide, subject to certain exceptions. Pursuant to this agreement, Ascensia has been responsible for the substantial majority of our historical revenue and our success is dependent on Ascensia effectively marketing and selling Eversense. Prior to our Commercialization Agreement with Ascensia, Ascensia had limited experience with marketing durable medical equipment and no experience marketing CGM systems. In order to strengthen commercial execution, in 2024, Ascensia established an independent dedicated business unit responsible for commercializing Eversense, which reports directly to Ascensia’s parent company, PHC Holdings Corporation (“PHC”), and Ascensia engaged a new president of CGM to lead that business unit.
Previous report
In an effort to accelerate Ascensia’s commercialization efforts, we have taken steps to address challenges to Eversense adoption by establishing Eon Care, which maintains a network of nurses to perform insertions, fully transitioning a network of inserters to Eon Care from the Nurse Practitioner Group in the second quarter. We have sought to complement Ascensia’s commercialization efforts by establishing a consignment program, whereby we sell the Eversense system and related components and supplies through a network of healthcare professionals, and have seen an increase in the percentage of our U.S. sales that take place through the consignment program. We have also increased our support of certain commercial programs such as direct to consumer (DTC) spending, certain key account activities, and market access support. In recent quarters, we have invested greater amounts in commercial activities, and expect to continue enhanced investment, in DTC spending. Although the rate of Eversense adoption has increased following these initiatives, as well as the regulatory approval of Eversense 365, we continue to work closely with Ascensia to accelerate commercialization and further adoption of our product.
Previous report
The Commercialization Agreement is terminable by either party if the other party materially breaches its obligations under the agreement; provided, however, that if Ascensia is unable to achieve the specified minimum spending or revenue targets outlined in the agreement, we will only have the right to convert Ascensia’s exclusive rights to nonexclusive rights. We regularly engage in discussions with Ascensia regarding the market opportunity for Eversense, the degree of spending on commercialization, and the potential impact of greater commercial support on product uptake. We also assess ways in which we can modify our plans or arrangements, and expand or introduce new commercial activities to accelerate commercialization and product adoption. As of the date of this report, we continue to assess with Ascensia its spending against target requirements for Ascensia’s fiscal year ended March 31, 2025, the implications of any failure to meet such targets, and the commercial needs of the business. We continue to discuss with Ascensia what adjustments may be required in commercial support or our arrangements to better pursue the potential of Eversense, and consider any constraints to such support or arrangements. If we and/or Ascensia were to elect to modify our Commercialization Agreement or other commercial arrangements, such changes could subject us to additional risks or uncertainties associated with product commercialization.
Previous report
The agreement is terminable by Ascensia under a number of circumstances, including if we undergo a change of control. The agreement is also terminable by either party if the other party undergoes bankruptcy, dissolution or winding up. We cannot guarantee this agreement with Ascensia will be successful, that it will continue, or that we will be able to achieve or maintain any particular volume of sales under the agreement or increase the volume of sales at a satisfactory pace or at all from this relationship in the future.
Previous report
Our revenue is dependent on the success of Ascensia in commercializing our product and its future versions. Our product is a new product for Ascensia globally and they must continue to establish certain functions of their U.S. commercial organization to successfully market and sell our CGM system. Ascensia’s continued organizational development of its sales and marketing capabilities will be critical to successful commercialization of our Eversense systems. If Ascensia is unable to maintain effective sales, marketing and other functions that are required to support the product, or achieve the increased levels of commercial support needed to support product expansion, it will have a materially negative impact on our net revenues from Eversense. As of the date of this report, we continue to assess with Ascensia its spending against targets for Ascensia’s fiscal year ended March 31, 2025, the implications of any failure to meet such targets, and the commercial needs of the business. We continue to discuss with Ascensia what adjustments may be required in commercial support or our arrangements to better pursue the potential of Eversense, and consider any constraints to such support or arrangements. If we and/or Ascensia were to elect to modify our Commercialization Agreement or other commercial arrangements, such changes could subject us to additional risks or uncertainties associated with product commercialization.
Previous report
prospects. In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described elsewhere in this report and in our Annual Report for the fiscal year ended December 31, 2024.
Reworded paragraphs (11)
Previous wording
Due to our limited operating history as a commercial-stage company, we may not have the institutional knowledge or experience to be able to effectively address these and other risks that may face our business. In addition, we may not be able to develop insights into trends that could emerge and negatively affect our business and may fail to respond effectively to those trends. Additionally, if our collaboration with Ascensia were to be modified, we could seek to take a greater role in the commercialization of Eversense, which would subject us to additional risks and uncertainties associated with those activities. As a result of these or other risks, we may not be able to execute key components of our business strategy, and our business, financial condition and operating results may suffer.
Current wording
Due to our limited operating history as a commercial-stage company, we may not have the institutional knowledge or experience to be able to effectively address these and other risks that may face our business. In addition, we may not be able to develop insights into trends that could emerge and negatively affect our business and may fail to respond effectively to those trends As a result of these or other risks, we may not be able to execute key components of our business strategy, and our business, financial condition and operating results may suffer.
Previous wording
If we are unable to successfully expand our commercialization of Eversense in the United States and Europe through our Commercialization Agreement with Ascensia, our business will be harmed.
Current wording
If we are unable to successfully expand our commercialization of Eversense in the United States and Europe our business will be harmed.
Previous wording
We have limited commercialization experience in both the United States and Europe. We have invested substantially all of our efforts and financial resources to the development and commercialization of Eversense. Our ability to generate revenue from our products will depend heavily on successful commercialization of products in the United States and Europe, which is entirely dependent on our collaboration with Ascensia, and on continuing development of future generations of our Eversense system. The success of any products that we develop will depend on several factors, including:
Current wording
We have limited commercialization experience in both the United States and Europe. We have invested substantially all of our efforts and financial resources to the development and commercialization of Eversense. Our ability to generate revenue from our products will depend heavily on successful commercialization of products in the United States and Europe and on continuing development of future generations of our Eversense system. The success of any products that we develop will depend on several factors, including:
Previous wording
Approval in the United States by the FDA or approval, or certification by a regulatory agency or Notified Body in another country does not guarantee approval, or certification by the regulatory authorities or Notified Bodies in other countries or jurisdictions or ensure approval, or certification for the same conditions of use. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Approval or certification processes vary among countries and can involve additional product testing and validation and additional administrative review periods. If we do not achieve one or more of these approvals, or certifications in a timely manner or at all, we could experience significant delays or an inability to fully commercialize Eversense and achieve profitability.
Current wording
Approval in the United States by the FDA or approval, or certification by a regulatory agency or notified nody in another country does not guarantee approval, or certification by the regulatory authorities or notified bodies in other countries or jurisdictions or ensure approval, or certification for the same conditions of use. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Approval or certification processes vary among countries and can involve additional product testing and validation and additional administrative review periods. If we do not achieve one or more of these approvals, or certifications in a timely manner or at all, we could experience significant delays or an inability to fully commercialize Eversense and achieve profitability.
Previous wording
Both before and after a product is commercially released, we will have ongoing responsibilities under U.S. and EU regulations. We will also be subject to periodic inspections by the FDA, the Notified Bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR, of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls. These inspections can result in observations or reports, warning letters or other similar notices or forms of enforcement action. If the FDA, or any comparable foreign regulatory authority concludes that we are not in compliance with applicable laws or regulations, or that any of our products are ineffective or pose an unreasonable health risk, such authority could ban these products, suspend, vary or cancel our marketing authorizations or CE Certificates of Conformity, impose “stop-sale” and “stop-import” orders, refuse to issue export certificates, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such products, or require us to notify health providers and others that the products present unreasonable risks of substantial harm to the public health. Discovery of previously unknown problems with our product's design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance or CE Certificate of Conformity for Eversense. The FDA, competent authorities of EEA countries and comparable
Current wording
Both before and after a product is commercially released, we will have ongoing responsibilities under U.S. and EU regulations. We will also be subject to periodic inspections by the FDA, the notified bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR, of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls. These inspections can result in observations or reports, warning letters or other similar notices or forms of enforcement action. If the FDA, or any comparable foreign regulatory authority concludes that we are not in compliance with applicable laws or regulations, or that any of our products are ineffective or pose an unreasonable health risk, such authority could ban these products, suspend, vary or cancel our marketing authorizations or CE Certificates of Conformity, impose “stop-sale” and “stop-import” orders, refuse to issue export certificates, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such products, or require us to notify health providers and others that the products present unreasonable risks of substantial harm to the public health. Discovery of previously unknown problems with our product’s design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance or CE Certificate of Conformity for Eversense. The FDA, competent authorities of EEA countries and comparable foreign regulatory authorities may also impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices, assess civil or criminal penalties against our officers, employees or us, or recommend criminal prosecution of our company. Adverse regulatory action may restrict us from effectively marketing and selling our products. In addition, negative publicity and product liability claims resulting from any adverse regulatory action could have a material adverse effect on our business, financial condition, and operating results.
Previous wording
In April 2025, we entered into a collaboration agreement with Sequel Med Tech (the “Sequel Collaboration”), for the purpose of integrating the companies’ technologies to jointly create the first ever automated insulin delivery system with a once-yearly CGM. The development program seeks to integrate Eversense 365 and Sequel’s twiist™ automated insulin delivery system to enable improved outcomes for people living with diabetes. We currently expect the integration of the companies’ products to be available to consumers in the fourth quarter of 2025. The Sequel Collaboration subjects us to additional risks in our business operations, including but not limited to:
Current wording
In April 2025, we entered into a collaboration agreement with Sequel Med Tech (the “Sequel Collaboration”), for the purpose of integrating the companies’ technologies to jointly create the first ever automated insulin delivery system with a once-yearly CGM. The development program seeks to integrate Eversense 365 and Sequel’s twiist™
Previous wording
We intend to continue to increase our operating expenses in connection with the commercialization of Eversense with our collaboration partner Ascensia, our ongoing research and development activities including the development of next generation products and the clinical trials for those products, and the commensurate development of our management and administrative functions. We will need to generate significant sales to achieve profitability, and we might not be able to do so. Even if we do generate significant sales, we might not be able to achieve, sustain or increase profitability on a quarterly or annual basis in the future. If our sales grow more slowly than we expect, if we take on additional commercialization responsibilities for Eversense, or if our operating expenses otherwise exceed our expectations, our financial performance and operating results will be adversely affected.
Current wording
We intend to continue to increase our operating expenses in connection with the commercialization of Eversense, our ongoing research and development activities including the development of next generation products and the clinical trials for those products, and the commensurate development of our management and administrative functions. We will need to generate significant sales to achieve profitability, and we might not be able to do so. Even if we do generate significant sales, we might not be able to achieve, sustain or increase profitability on a quarterly or annual basis in the future. If our sales grow more slowly than we expect, if we take on additional commercialization responsibilities for Eversense, or if our operating expenses otherwise exceed our expectations, our financial performance and operating results will be adversely affected.
Previous wording
We are highly dependent on the management, research and development, clinical, financial and business development expertise of Tim Goodnow, our Chief Executive Officer, Rick Sullivan, our Chief Financial Officer, Mukul Jain, our Chief Operating Officer, and Ken Horton, our General Counsel and Corporate Development Advisor, as well as the other members of our scientific and clinical teams. Although we have employment agreements with our executive officers, each of them may terminate their employment with us at any time and will continue to be able to do so. We do not maintain "key person" insurance for any of our executives or employees.
Current wording
the other members of our scientific and clinical teams. Although we have employment agreements with our executive officers, each of them may terminate their employment with us at any time and will continue to be able to do so. We do not maintain “key person” insurance for any of our executives or employees.
Previous wording
Recruiting and retaining qualified scientific, clinical and marketing personnel are critical to our success. The loss of the services of our executive officers or other key employees, or the inability to add required staff, could impede the achievement of our research, development and commercialization objectives or the expansion of activities to support Eversense, and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous medical device companies for similar personnel, many of which have greater financial and other resources dedicated to attracting and retaining personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.
Current wording
Recruiting and retaining qualified scientific, clinical and marketing personnel are critical to our success. In addition, as we resume responsibility for the commercialization of our products, we will also be required to recruit and retain a qualified sales force and supporting functions. The loss of the services of our executive officers or other key employees, or the inability to add required staff, could impede the achievement of our research, development and commercialization objectives or the expansion of activities to support Eversense, and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous medical device companies for similar personnel, many of which have greater financial and other resources dedicated to attracting and retaining personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.
Previous wording
We may need to expand our development and regulatory capabilities and our marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
Current wording
We will need to expand our sales and marketing and potentially other capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
Previous wording
As of December 31, 2024, we had 117 full-time employees. As our commercialization progresses, we may experience significant growth in the number of our employees and the scope of our operations, particularly in the areas
Current wording
As of December 31, 2024, we had 117 full-time employees. As we resume responsibility for the commercialization of our products, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of sales and marketing and commercial operations. We also may experience growth in the number of employees in the areas of research, product development, clinical sciences, regulatory affairs, supply chain, logistics, clinical/insertion services, or additional commercial activities. To manage our future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
automated insulin delivery system to enable improved outcomes for people living with diabetes. We are actively working towards the integration of the companies’ products to be completed in the fourth quarter of 2025 and available to consumers shortly thereafter. The Sequel Collaboration subjects us to additional risks in our business operations, including but not limited to:
Current report — wording carried from elsewhere
We are highly dependent on the management, research and development, clinical, financial and business development expertise of Tim Goodnow, our Chief Executive Officer, Rick Sullivan, our Chief Financial Officer, Mukul Jain, our Chief Operating Officer, and Ken Horton, our General Counsel and Corporate Development Advisor, as well as
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
foreign regulatory authorities may also impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices, assess civil or criminal penalties against our officers, employees or us, or recommend criminal prosecution of our company. Adverse regulatory action may restrict us from effectively marketing and selling our products. In addition, negative publicity and product liability claims resulting from any adverse regulatory action could have a material adverse effect on our business, financial condition, and operating results.