SENS on Nasdaq

Senseonics (United States)

Logo: senseonics.com3

American industrial instruments for measurement company based in Germantown1

In its 2026 annual report the company says: “We are a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring system to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy.”5 It was founded in 1996.1 Its shares trade on Nasdaq under the symbol SENS.1

Price unavailable

Last updated Oct 21, 2026.

Overview

1996Founded1

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  • TickerSENS on Nasdaq1
  • IndustryIndustrial Instruments For Measurement, Display, and Control1
  • HeadquartersGermantown1
  • Websitesenseonics.com
  • Incorporated inDE4
  • Business address20451 Seneca Meadows Parkway, Germantown, Md 208764
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation

We are a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (“CGM”) system to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy. Our implantable CGM system (“Eversense”), including Eversense E3 and Eversense 365 CGM systems are designed to continually and accurately measure glucose levels in people with diabetes via an under-the-skin sensor, a removable and rechargeable smart transmitter, and a convenient app for real-time diabetes monitoring and management for a period of up to twelve months in the case of Eversense 365 and six months in the case of Eversense E3, as compared to seven to 15 days for non-implantable CGM systems. In September 2024, the 365-day extended life Eversense E3 CGM system was approved by the FDA and, through …5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

44.7%Gross margin6
-193.8%Operating margin6
-196.0%Net margin7
56.9%Revenue growth, 20256
-113.2%Return on equity6
0.58×Debt to equity6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Regions

United States brought in 79% of the revenue Senseonics (United States) broke down this way in fiscal 2025.

  1. United States$27.9M679%up 83% from 2024
  2. Outside the United States$7.3M621%up 2% from 2024
Regions by year
Regions20242025
United States$15.3M$27.9M
Outside the United States$7.2M$7.3M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue19¢$19.5M
  • Research and development30¢$31.6M
  • Selling, general and admin51¢$52.5M

Out of $35.3M in revenue.67 The company lost money this year.

Financial statements

Revenue8910116$35.3M in 2025+616% since 2019
0$10.0M$20.0M$30.0M$40.0M2019: $4.9M$4.9M20192020: $1.4M$1.4M2020−72%2021: $1.4M$1.4M2021+2%2022: $16.4M$16.4M2022+1076%2023: $22.4M$22.4M2023+37%2024: $22.5M$22.5M2024+0%2025: $35.3M$35.3M2025+57%
Gross profit81210116$15.8M in 2025
-$20.0M-$10.0M0$10.0M$20.0M2019: -$19.4M-$19.4M20192020: -$17.4M-$17.4M2020−11%2021: -$800.0K-$800.0K2021−95%2022: $2.7M$2.7M20222023: $3.1M$3.1M2023+13%2024: $533.0K$533.0K2024−83%2025: $15.8M$15.8M2025+2857%
Operating income8910116-$68.3M in 2025−48% since 2019
-$150.0M-$100.0M-$50.0M02019: -$130.7M-$130.7M20192020: -$79.1M-$79.1M2020−39%2021: -$57.2M-$57.2M2021−28%2022: -$68.6M-$68.6M2022+20%2023: -$75.6M-$75.6M2023+10%2024: -$74.8M-$74.8M2024−1%2025: -$68.3M-$68.3M2025−9%
Net income13914157-$69.1M in 2025−40% since 2019
-$400.0M-$200.0M0$200.0M2019: -$115.5M-$115.5M20192020: -$175.2M-$175.2M2020+52%2021: -$302.5M-$302.5M2021+73%2022: $142.1M$142.1M20222023: -$60.4M-$60.4M20232024: -$78.6M-$78.6M2024+30%2025: -$69.1M-$69.1M2025−12%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Revenue, net$35.3M$22.5M
Cost of sales$19.5M$21.9M
Gross profit$15.8M$533.0K
Research and development expenses$31.6M$41.1M
Selling, general and administrative expenses$52.5M$34.2M
Operating loss-$68.3M-$74.8M
Interest income$4.2M$4.5M
Interest expense-$5.0M-$8.4M
Gain on change in fair value of derivatives$102.0K
Other expense ( income)-$23.0K$59.0K
Total other expense, net-$776.0K-$3.8M
Net Loss-$69.1M-$78.6M
Unrealized gain on marketable securities$69.0K$11.0K
Total other comprehensive income$69.0K$11.0K
Total comprehensive loss-$69.0M-$78.6M
Basic net loss per common share-$1.66-$2.50
Basic weighted-average shares outstanding41.7M shares31.5M shares
Diluted net loss per common share-$1.66-$2.50
Diluted weighted-average shares outstanding41.7M shares31.5M shares

Compare Senseonics (United States) with another company

Corporate structure

Senseonics (United States) sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Senseonics (United States)

  • Sessa Capital IM, L.P. Filed SCHEDULE 13G on Senseonics (United States), latest Aug 14, 2026
  • BlackRock Filed SCHEDULE 13G on Senseonics (United States), latest Jul 30, 2026 (4 filings since Feb 4, 2022)
  • Robert J. Smith Filed SCHEDULE 13G/A on Senseonics (United States), latest Aug 8, 2025 (2 filings since Apr 10, 2023)
  • VANGUARD GROUP INC Filed SC 13G/A on Senseonics (United States), latest Feb 13, 2024 (2 filings since Feb 9, 2023)
  • PHC Holdings Corp Filed SC 13D/A on Senseonics (United States), latest Mar 20, 2023
  • GILDER GAGNON HOWE & CO LLC Filed SC 13G/A on Senseonics (United States), latest Feb 14, 2022
  • HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SC 13G/A on Senseonics (United States), latest Feb 11, 2022
  • Senseonics (United States) Germantown

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Senseonics (United States) 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.

Property and equipment

ItemLatestA year beforeChange
Operating-lease assets (leased space)$4.5M6 Dec 31, 2025$4.8M6 Dec 31, 2024−7.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$40.2M6 Dec 31, 2025$74.6M6 Dec 31, 2024−46.1%
Marketable securities, current$53.8M6 Dec 31, 2025$33.7M11 Dec 31, 2023+59.4%
Debt securities available for sale$53.8M6 Dec 31, 2025$33.7M10 Dec 31, 2023+59.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, net$600.0K6 Dec 31, 2025

Inventory

ItemLatestA year beforeChange
Inventory, total$6.7M6 Dec 31, 2025$4.4M6 Dec 31, 2024+51.6%
Work in process$3.6M6 Dec 31, 2025$3.2M6 Dec 31, 2024+13.0%
Finished goods$2.6M6 Dec 31, 2025$781.0K6 Dec 31, 2024+230.3%

Properties, in its own words

Our principal offices occupy approximately 33,000 square feet of research and office space for our corporate headquarters in Germantown, Maryland pursuant to a lease that expires in 2033. We believe that our current facilities are suitable and adequate to meet our current needs. We intend to add new facilities or expand existing facilities as we add employees, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

Item 2 of the 10-K filed Mar 2, 2026.5

Leadership

Who has led Senseonics (United States), and when. Pick a name to see everywhere that person has worked.

Board members and other officers (20)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerRick L. Sullivan named Nov 8, 2024 to May 29, 202543
  • DirectorEdward J. Fiorentino named Nov 8, 2024 to May 29, 202543
  • DirectorKoichiro A. Sato named Nov 8, 2024 to May 29, 202543
  • DirectorSteven P. Edelman named Nov 8, 2024 to May 29, 202543

Former names

  • Senseonics Holdings, Inc.Dec 10, 2015 to Oct 5, 20264
  • ASN Technologies, Inc.Aug 15, 2014 to Nov 13, 20154

Timeline

  1. Aug 6, 20268-K Results of operations44
  2. Jun 8, 20268-K Other events45
  3. May 20, 20268-K Bylaws or fiscal year changed; Shareholder vote46
  4. May 7, 20268-K Results of operations47
  5. May 4, 20268-K Entered a material agreement; New debt or obligation48
  6. May 1, 20268-K Entered a material agreement; Results of operations; Regulation FD disclosure49
  7. Mar 12, 20268-K Entered a material agreement50
  8. Mar 2, 20268-K Results of operations51
  9. Jan 12, 20268-K Results of operations; Other events52
  10. Jan 2, 20268-K Entered a material agreement; Executive or director change53
  11. Nov 5, 20258-K Results of operations54
  12. Oct 16, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed55
  13. Apr 14, 2016New chief executive Timothy T. Goodnow becomes CEO18
  14. 1996Founded Founded1

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.43) a share, on Nov 5, 2025.56

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results44
  2. May 7, 2026Reported quarterly or annual results47
  3. May 1, 2026Reported quarterly or annual results49
  4. Mar 2, 2026Reported quarterly or annual results51
  5. Jan 12, 2026Reported quarterly or annual results52
  6. Nov 5, 2025Reported quarterly or annual results54
  7. Oct 6, 2025Reported quarterly or annual results57
  8. Aug 6, 2025Reported quarterly or annual results58

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

392 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 55 major events, 238 insider forms, 12 large holders, 2 private raises, 65 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Oct 5, 20264 EDGAR
  3. Oct 5, 20264 EDGAR
  4. Oct 5, 20264 EDGAR
  5. Aug 20, 20264 EDGAR
  6. Aug 14, 2026SCHEDULE 13G EDGAR
  7. Aug 6, 202610-Q EDGAR
  8. Aug 6, 20268-K EDGAR
  9. Jul 30, 2026SCHEDULE 13G EDGAR
  10. Jul 2, 20264 EDGAR
  11. Jul 2, 20264 EDGAR
  12. Jul 2, 20264 EDGAR
  13. Jul 2, 20264 EDGAR
  14. Jun 17, 20264 EDGAR
  15. Jun 17, 20264 EDGAR
  16. Jun 17, 20264 EDGAR
  17. Jun 17, 20264 EDGAR
  18. Jun 17, 20264 EDGAR
  19. Jun 17, 20264 EDGAR
  20. Jun 8, 20268-K EDGAR

The 392 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

26 open-market trades by officers, directors and large owners since October 2021: 14 buys and 12 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 19, 2026ROEDER DOUGLAS ADirectorBuy13,953$8.98$125.3KForm 4
May 12, 2026ROEDER DOUGLAS ADirectorBuy22,686$5.56$126.1KForm 4
Mar 13, 2026Goodnow Timothy TPresident and CEOBuy17,225$5.79$99.7KForm 4
Mar 13, 2026ROEDER DOUGLAS ADirectorBuy17,500$5.73$100.3KForm 4
Nov 10, 2025Steven EdelmanDirectorBuy10,000$6.55$65.5KForm 4
Nov 7, 2025Sullivan Frederick T.Chief Financial OfficerBuy5,415$5.88$31.8KForm 4
Nov 7, 2025Goodnow Timothy TPresident and CEOBuy17,210$5.87$101.0KForm 4
Nov 7, 2025ROEDER DOUGLAS ADirectorBuy15,000$5.83$87.5KForm 4
Dec 13, 2024ROEDER DOUGLAS ADirectorBuy75,000$0.50$37.5KForm 4
Dec 13, 2024ROEDER DOUGLAS ADirectorBuy25,000$0.50$12.5KForm 4
Dec 12, 2024ROEDER DOUGLAS ADirectorBuy300,000$0.41$123.0KForm 4
Dec 12, 2024Sullivan Frederick T.Chief Financial OfficerBuy124,933$0.38$47.5KForm 4
Dec 10, 2024Goodnow Timothy TPresident and CEOBuy315,000$0.31$97.7KForm 4
Sep 7, 2023Larkin SharonDirectorSale30,889$0.61$18.8KForm 4
Aug 30, 2023ROEDER DOUGLAS ADirectorBuy300,000$0.54$162.0KForm 4
Aug 4, 2022JAIN MukulChief Operating OfficerSale50,000$1.97$98.5KForm 4
Mar 11, 2022Fiorentino EdwardDirectorSale63,553$1.65$104.9KForm 4
Feb 11, 2022Tressler Nick B.Chief Financial OfficerSale72,873$2.46$179.3KForm 4
Feb 11, 2022Panlilio MirasolVP Global Sales and MarketingSale105,760$2.46$260.2KForm 4
Feb 11, 2022Kaufman FrancineChief Medical OfficerSale163,870$2.46$403.1KForm 4

All 26 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

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.

YearExecutiveAgeSalaryTotal pay
2025Timothy T. GoodnowPresident and Chief Executive$635.0K$3.3M66
2025Mukul Jain, Ph.D.Chief Operating Officer$511.0K$1.9M66
2025Frederick (“Rick”) SullivanChief Financial Officer$430.0K$1.4M66
2024Timothy T. GoodnowPresident and Chief Executive$613.0K$3.3M66
2024Mukul Jain, Ph.D.Chief Operating Officer$493.0K$1.9M66

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$36.3M 2024–2025
Money received by yearMoney received by year, 2024–2025: $36.3M in all. Private raises (Form D) $36.3M.$0$10M$20M$30M2024 · Private raises (Form D): $16.0M20242025 · Private raises (Form D): $20.3M2025
Figures by year
YearPrivate raises (Form D)Total
2025$20.3M$20.3M
2024$16.0M$16.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. May 20, 2025Raised $20.3 million in a private offering of equity43 Form D: 1 investor so far Form D
  2. Oct 28, 2024Raised $16 million in a private offering of equity67 Form D: 1 investor so far Form D

Held by these funds

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.

FundSharesValueShare of the fundChange
Sessa Capital IM, L.P.4,437,532$25.2M0.4%+2,671,439
BlackRock, Inc.2,793,558$15.9M0.0%+2,224,829
Vanguard Capital Management LLC1,779,398$10.1M0.0%+162,201
Avidity Partners Management LP1,600,000$9.1M1.5%New
Sio Capital Management, LLC1,592,692$9.0M1.6%+1,476,908
UBS Group AG1,487,429$8.4M0.0%+1,039,200
Geode Capital Management, LLC1,132,210$6.4M0.0%+665,695
Masters Capital Management LLC700,000$4.0M0.6%+200,000
State Street Corp511,117$2.9M0.0%+330,836
Marshall Wace, Llp405,695$2.3M0.0%−58,680
Bank Of America Corp /de/394,465$2.2M0.0%+337,501
Charles Schwab Investment Management Inc393,211$2.2M0.0%+172,034
Northern Trust Corp332,266$1.9M0.0%+249,989
Vanguard Fiduciary Trust Co331,353$1.9M0.0%+106,186
Walleye Capital LLC324,264$1.8M0.0%New
Vanguard Portfolio Management LLC272,375$1.5M0.0%New
Goldman Sachs Group Inc231,509$1.3M0.0%+85,227
Morgan Stanley164,984$937.1K0.0%+41,041
Russell Investments Group, Ltd.153,216$870.3K0.0%+153,209
Trexquant Investment LP135,128$767.5K0.0%New
Ghisallo Capital Management LLC125,000$710.0K0.0%New
Readystate Asset Management LP101,000$573.7K0.0%New
Penn Capital Management Company, LLC94,140$534.7K0.0%New
Sei Investments Co85,738$487.0K0.0%+36,146
Bank of New York Mellon Corp84,483$479.9K0.0%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Senseonics (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARSenseonics Holdings, Inc.2
  • CIK0001616543
  • Employer ID (EIN)47-12109115
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)3823 Industrial Instruments For Measurement, Display, and Control2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address20451 Seneca Meadows Parkway, Germantown, MD 208762
  • Phone(301) 515-72602
  • Shares outstanding52,874,053 as of Jul 31, 20267
  • Public float$376.7M as of Jun 30, 20255
  • AuditorKPMG LLP, Baltimore, Maryland PCAOB ID 185; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceAug 15, 20142
  • Filings898 in all: 4 (439), 8-K (137), 10-Q (36), 3 (30), CORRESP (24), 424B5 (21), SC 13G/A (20), SC 13D/A (16)2
    All 45 form types

    SC 13G (16), UPLOAD (16), EFFECT (14), DEF 14A (13), 10-K (12), S-3 (12), DEFA14A (9), 4/A (7), PRE 14A (7), S-8 (7), S-1/A (6), SD (6), 8-K/A (5), ARS (4), CT ORDER (4), D (4), S-3/A (4), SC 13D (4), 424B3 (2), 8-A12B (2), FWP (2), S-1 (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 10-K/A (1), 144 (1), 25 (1), 305B2 (1), 424B4 (1), 424B7 (1), CERT (1), CERTNYS (1), DEFR14A (1), PRER14A (1), S-3ASR (1), S-3MEF (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 2, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 6, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareSENSNasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Senseonics (United States) names in Item 1A of its 10-K filed Mar 2, 2026: 67 risks under these headings, as written.5

  • Risks Relating to our Business and our Industry
  • We have incurred significant operating losses since inception and cannot assure you that we will ever achieve or sustain profitability.
  • The transition of commercial responsibility for Eversense to Senseonics in European markets is subject to the finalization and execution of definitive agreements with Ascensia and an uncertain government approval process.
  • Our resumption of commercial responsibility for Eversense will require us to develop a number of internal functions and may not be successful.
  • We have limited operating history as a commercial-stage company and may face difficulties encountered by companies early in their commercialization in competitive and rapidly evolving markets.
  • If we are unable to successfully expand our commercialization of Eversense in the United States and Europe our business will be harmed.
  • Our collaboration agreement with Sequel Med Tech may not lead to the benefits that we anticipate.
  • We are dependent on one product, Eversense. Our success depends on our ability to continue to develop, commercialize and gain market acceptance for our products.
  • We contract with third parties for the manufacture of Eversense. Risks associated with the manufacturing of our products could reduce our gross margins and negatively affect our operating results.
  • We depend on a limited number of third-party suppliers for the components of Eversense and the loss of any of these suppliers, or their inability to provide us with an adequate supply of materials, could harm our business.
  • Our third-party suppliers operate primarily at facilities in a single location, and any disruption to these facilities could adversely affect our business and operating results.
  • If we do not enhance our product offerings through our research and development efforts, we may fail to effectively compete or become profitable.
The other 56 risks
  • Failure to secure or retain coverage or adequate reimbursement for Eversense or future versions of Eversense systems, including the related insertion and removal procedures, by third-party payors, and an inability of patients to be able to access the product, could adversely affect our business, financial condition and operating results.
  • If important assumptions we have made about what people with intensively managed diabetes are seeking in a CGM system are inaccurate, our business and operating results may be adversely affected.
  • We operate in a very competitive industry and if we fail to compete successfully against our existing or potential competitors, many of whom have greater resources than we have, our sales and operating results may be negatively affected.
  • Competitive products or other technological innovations for the monitoring, treatment or prevention of diabetes may render our products less competitive or obsolete.
  • The size and future growth in the market for CGM systems and CGM-related products has not been established with precision and may be smaller than we estimate, possibly materially. If our estimates and projections overestimate the size of this market, our sales growth may be adversely affected.
  • Our ability to maintain and grow our revenue will depend on establishing a customer base and retaining a high percentage of our customer base.
  • Various factors outside our direct control may adversely affect manufacturing, sterilization and distribution of our products.
  • Potential complications from Eversense or future versions of Eversense may not be revealed by our clinical experience.
  • Undetected errors or defects in Eversense or future versions of Eversense could harm our reputation, decrease the market acceptance of Eversense or expose us to product liability claims.
  • We may enter into collaborations, in-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 revenues.
  • We may seek to grow our business through acquisitions of complementary products or technologies, and the failure to manage acquisitions, or the failure to integrate them with our existing business, could harm our business, financial condition and operating results.
  • Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises such as pandemics, political crises, geopolitical events, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • Risks Related to our Financial Results and Need for Financing
  • We will need to generate significant sales to achieve profitable operations.
  • 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.
  • Our operating results may fluctuate from quarter to quarter or year to year.
  • Our product revenue is subject to seasonal variation
  • Covenants under the Loan and Security Agreement may result in the acceleration of outstanding indebtedness and limit the manner in which we operate.
  • Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt.
  • Despite our current debt levels, subject to certain conditions and limitations, we may still incur substantially more debt or take other actions which would intensify the risks discussed above.
  • Our business may be exposed to foreign exchange risks.
  • There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
  • Risks Related to Development of our Products
  • If we modify our approved product or CE Marked, we may need to seek additional approvals or CE Certificates of Conformity, which, if not granted, would prevent us from selling our modified products.
  • Medical device development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, ongoing development for lifecycle management of our products.
  • Risks Related to Employee Matters and Managing our Growth
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • 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.
  • Our employees, independent contractors, consultants, manufacturers and distributors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • We may incur product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses.
  • Risks Related to our Intellectual Property
  • Our ability to protect our intellectual property and proprietary technology is uncertain.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may be subject to damages resulting from claims that we, or our employees, have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • Our intellectual property rights do not necessarily address all potential competitive threats or confer meaningful competitive benefits.
  • Risks Related to our Legal and Regulatory Environment
  • The FDA regulatory clearance process and regulatory processes in other countries are expensive, time-consuming and uncertain, and the failure to obtain and maintain required regulatory clearances, certification and approvals could prevent us from commercializing Eversense and future versions of Eversense.
  • If we or our third-party suppliers fail to comply with the FDA's or other foreign regulatory authorities’ good manufacturing practice regulations, this could impair our ability to market our products in a cost-effective and timely manner.
  • A recall of our products, or the discovery of serious safety issues with our products, could have a significant negative impact on us.
  • We are subject to the U.K. Bribery Act, the U.S. Foreign Corrupt Practices Act and other anti-corruption and anti-money-laundering laws in foreign jurisdictions, as well as export control laws, customs laws, sanctions laws and other laws governing our future global operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, which could adversely affect our business, results of operations and financial condition.
  • We are subject to additional federal, state and foreign laws and regulations relating to our healthcare business; our failure to comply with those laws could have an adverse impact on our business.
  • We are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, 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 revenue or profits; loss of customers or sales; and other adverse business consequences.
  • If our information technology systems or those third parties with whom we work, or our data, 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; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
  • We may be liable if the FDA, competent authorities of the EEA countries, or another regulatory agency concludes that we have engaged in the off-label promotion of our products.
  • Off-label use of our product by patients could lead to product liability claims and regulatory action.
  • Legislative or regulatory healthcare reforms may make it more difficult and costly for us to obtain regulatory clearance, certification or approval of our products or otherwise impact our profitability.
  • Risks Related to our Common Stock
  • Because our stock price has and will likely continue to be highly volatile, the market price of our common stock may be lower or more volatile than expected.
  • The issuance of additional stock in connection with financings, acquisitions, investments, our equity incentive plans, or otherwise will dilute our existing stockholders.
  • PHC may have the ability exert substantial influence over us in a manner adverse to your interests.
  • The rights that we have granted to Abbott in connection with a recent private placement may affect the likelihood of a change of control of Senseonics.
  • If our estimates relating to our critical accounting policies are based on assumptions or judgments that change or prove to be incorrect, our operating results could fall below expectations of financial analysts and investors, resulting in a decline in our stock price.
  • We do not intend to pay cash dividends in the foreseeable future.
  • Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
  • Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
  • We may be unable to utilize our tax attribute carryforwards to reduce our income taxes.
  • Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition, or results of operations.
  • Our bank deposits in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limits could be impacted if the underlying financial institutions fail.

Legal proceedings

From time to time, we are subject to litigation and claims arising in the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters will not have a material adverse effect on our business. Legal proceedings, including litigation, government investigations and enforcement actions could result in material costs, occupy significant management resources and entail civil and criminal penalties.

The opening of Item 3, Legal Proceedings.5

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