Senseonics Q3 loss widens to $32.7M as revenue rises
Management believes existing cash and cash equivalents, together with anticipated cash flows, will fund operations and obligations for at least 12 months from issuance.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Senseonics Holdings, Inc. (SENS) reported third-quarter 2026 revenue of $19.561 million, compared with $8.095 million a year earlier, while net loss was $32.677 million versus $19.530 million. For the nine months, revenue was $45.756 million and net loss was $101.715 million, compared with $21.001 million and $48.290 million, respectively, in 2025. U.S. commercialization returned to the company in January 2026; it assumed primary responsibilities in Spain and Sweden in June, Germany in August, and substantially all activities in Italy during the third quarter.
Operating cash use for the nine months was $95.099 million, while unrestricted cash, cash equivalents and marketable securities totaled $126.3 million as of September 30, 2026. Management believes existing cash and cash equivalents, together with anticipated cash flows, will fund operations and obligations for at least the next twelve months from issuance of the statements. The carrying amount of debt was $56.229 million, and the company reported compliance with all covenants as of September 30, 2026.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointThird-quarter revenue reached $19.561 million, versus $8.095 million a year earlier.
Negative
- Moderate pointThird-quarter net loss was $32.677 million, versus $19.530 million a year earlier.
- Moderate pointNine-month operating cash use was $95.099 million, versus $41.164 million.
Filing Explained
At September 30, 2026, the $140 million loan ceiling included conditional and uncommitted capacity, not just funded debt.
This Form 10-Q reports unaudited results for the quarter ended
The amended loan facility allows up to
Key Figures
Key Terms
continuous glucose monitoring medical
pre-funded warrants financial
minimum cash covenant financial
ATM offering financial
variable interest entities financial
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much revenue did SENS report in Q3 2026?
What was SENS's net loss in Q3 2026?
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AI-generated analysis. How Rhea-AI works. Not financial advice.
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the Quarterly Period Ended
or
For the transition period from ______ to ______
Commission file number:
(Exact name of registrant as specified in its charter)
| 3841 |
|
(
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
Emerging growth company | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
There were
Table of Contents
TABLE OF CONTENTS
PART I: Financial Information | | |
| | |
ITEM 1: Financial Statements | | |
| | |
Condensed Consolidated Balance Sheets as of September 30, 2026 (Unaudited) and December 31, 2025 | | 3 |
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2026 and 2025 | | 4 |
Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2026 and 2025 | | 5 |
Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 | | 6 |
Notes to Unaudited Condensed Consolidated Financial Statements | | 7 |
| | |
ITEM 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 29 |
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ITEM 3: Quantitative and Qualitative Disclosures About Market Risk | | 42 |
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ITEM 4: Controls and Procedures | | 42 |
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PART II: Other Information | | 42 |
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ITEM 1: Legal Proceedings | | 42 |
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ITEM 1A: Risk Factors | | 42 |
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ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds | | 43 |
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ITEM 3: Defaults Upon Senior Securities | | 43 |
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ITEM 4: Mine Safety Disclosures | | 43 |
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ITEM 5: Other Information | | 43 |
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ITEM 6: Exhibits | | 44 |
| | |
SIGNATURES | | 46 |
| | |
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Senseonics Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
| | | (unaudited) | | | |
| | | | | | |
Assets | | | | | | |
Current assets: | | | | | | |
Cash and cash equivalents | | $ | | | $ | |
Restricted cash | | | | | | |
Short-term investments, net | | | | | | |
Accounts receivable, net | | | | | | |
Accounts receivable, net - related parties | | | — | | | |
Inventory, net | | | | | | |
Prepaid expenses and other current assets | |
| | |
| |
Total current assets | |
| | |
| |
| | | | | | |
Deposits and other assets | |
| | |
| |
Property, equipment and intangible assets, net | |
| | |
| |
Total assets | | $ | | | $ | |
Liabilities and Stockholders’ Equity | | | | | | |
Current liabilities: | | | | | | |
Accounts payable | | $ | | | $ | |
Accrued expenses and other current liabilities | |
| | |
| |
Accrued expenses and other current liabilities, related parties | | | | | | |
Notes payable, current portion, net | | | | | | — |
Total current liabilities | |
| | |
| |
| | | | | | |
Long-term debt and notes payable, net | | | | | | |
Non-current operating lease liabilities | | | | | | |
Total liabilities | |
| | |
| |
| | | | | | |
Commitments and contingencies | | | | | | |
| | | | | | |
Stockholders’ equity: | | | | | | |
Common stock, $ | |
| | |
| |
Additional paid-in capital | |
| | |
| |
Accumulated other comprehensive income (loss) | | | ( | | | |
Accumulated deficit | |
| ( | |
| ( |
Total stockholders’ equity | |
| | |
| |
Total liabilities and stockholders’ equity | | $ | | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Senseonics Holdings, Inc.
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | ||||||||
| | September 30, | | September 30, | ||||||||
| | 2026 | | 2025 | | 2026 | | 2025 | ||||
Revenue, net | | $ | | | $ | | | $ | | | $ | |
Revenue, net - related parties | | | | | | | | | | | | |
Total revenue | | | | | | | | | | | | |
Cost of sales | | | | | | | | | | | | |
Gross profit | | | | | | | | | | | | |
| | | | | | | | | | | | |
Expenses: | | | | | | | | | | | | |
Research and development expenses | | | | |
| | | | | | | |
Selling, general and administrative expenses | | | | |
| | | | | |
| |
Operating loss | | | ( | |
| ( | | | ( | |
| ( |
Other (expense) income, net: | | | | | | | | | | | | |
Interest income | | | | | | | | | | | | |
Interest expense | | | ( | | | ( | | | ( | | | ( |
Other (expense) income | | | ( | | | | | | ( | | | ( |
Total other (expense) income, net | | | ( | | | | | | ( | | | ( |
| | | | | | | | | | | | |
Net Loss | | | ( | | | ( | | | ( | | | ( |
Other comprehensive loss | | | | | | | | | | | | |
Translation adjustments | | | | | | — | | | | | | — |
Unrealized (loss) gain on marketable securities | | | ( | | | | | | ( | | | |
Other comprehensive (loss) gain | | | ( | | | | | | ( | | | |
Total comprehensive loss | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
| | | | | | | | | | | | |
Basic net loss per common share | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
Basic weighted-average shares outstanding | | | | | | | | | | | | |
| | | | | | | | | | | | |
Diluted net loss per common share | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
Diluted weighted-average shares outstanding | | | | | | | | | | | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Senseonics Holdings, Inc.
Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity
(in thousands)
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | Accumulated | | | | | | | | | Series B | |
| | Common Stock | | Paid-In | | Other | | Accumulated | | Stockholders' | | Convertible | ||||||||
| | Shares | | Amount | | Capital | | Comprehensive Loss | | Deficit | | Equity | | Preferred Stock Temporary Equity | ||||||
Three months ended September 30, 2025: | | | | | | | | | | | | | | | | | | | | |
Balance, June 30, 2025 | | | | $ | | | $ | | | $ | | | $ | ( | | $ | | | $ | — |
Issuance of common stock, net of issuance costs | | | | | — | | | | | | — | | | — | | | | | | — |
Issued common stock for vested RSUs and ESPP purchases | | | | | — | | | | | | — | | | — | | | | | | — |
Issuance of warrants, net of issuance costs | | — | | | — | | | ( | | | — | | | — | | | ( | | | — |
Stock-based compensation expense | | — | | | — | | | | | | — | | | — | | | | | | — |
Net loss | | — | | | — | | | — | | | — | | | ( | | | ( | | | — |
Other comprehensive income, net of tax | | — | | | — | | | — | | | | | | — | | | | | | — |
Balance, September 30, 2025 | | | | $ | | | $ | | | $ | | | $ | ( | | $ | | | $ | — |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Nine months ended September 30, 2025: | | | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2024 |
| | | $ | | | $ | | | $ | — | | $ | ( | | $ | ( | | $ | |
Conversion of preferred stock | | | | | | | | | | | — | | | — | | | | | | ( |
Issuance of common stock, net of issuance costs | | | | | | | | | | | — | | | — | | | | | | — |
Issued common stock for vested RSUs and ESPP purchases | | | | | — | | | | | | — | | | — | | | | | | — |
Issuance of warrants, net of issuance costs | | — | | | — | | | ( | | | — | | | — | | | ( | | | |
Stock-based compensation expense |
| — | | | — | | | | | | — | | | — | | | | | | — |
Shares withheld related to net share settlement of equity awards | | ( | | | — | | | ( | | | — | | | — | | | ( | | | — |
Net loss | | — | | | — | | | — | | | — | | | ( | | | ( | | | — |
Other comprehensive income, net of tax |
| — | | | — | | | — | | | | | | — | | | | | | — |
Balance, September 30, 2025 |
| | | $ | | | $ | |
| $ | | | $ | ( | | $ | | | $ | — |
| | | | | | | | | | | | | | | | | | | | |
Three months ended September 30, 2026: | | | | | | | | | | | | | | | | | | | | |
Balance, June 30, 2026 | | | | $ | | | $ | | | $ | ( | | $ | ( | | $ | | | $ | — |
Issuance of common stock, net of issuance costs | | | | | | | | | | | — | | | — | | | | | | — |
Issued common stock for vested RSUs and ESPP purchases | | | | | — | | | | | | — | | | — | | | | | | — |
Stock-based compensation expense | | — | | | — | | | | | | — | | | — | | | | | | — |
Net loss | | — | | | — | | | — | | | — | | | ( | | | ( | | | — |
Other comprehensive loss | | — | | | — | | | — | | | ( | | | — | | | ( | | | — |
Balance, September 30, 2026 | | | | $ | | | $ | | | $ | ( | | $ | ( | | $ | | | $ | — |
| | | | | | | | | | | | | | | | | | | | |
Nine months ended September 30, 2026: | | | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2025 | | | | $ | | | $ | | | $ | | | $ | ( | | $ | | | $ | — |
Issuance of common stock, net of issuance costs |
| | | | | | | | | | — | | | — | | | | | | — |
Issuance of pre-funded warrants in connection with public offering, net of issuance costs | | — | | | — | | | | | | — | | | — | | | | | | — |
Issuance of warrants in connection with amendment to Loan and Security Agreement | | — | | | — | | | | | | — | | | — | | | | | | — |
Issued common stock for vested RSUs and ESPP purchases | | | | | | | | | | | — | | | — | | | | | | — |
Stock-based compensation expense | | — | | | — | | | | | | — | | | — | | | | | | — |
Shares withheld related to net share settlement of equity awards | | ( | | | — | | | ( | | | — | | | — | | | ( | | | — |
Net loss | | — | | | — | | | — | | | — | | | ( | | | ( | | | — |
Other comprehensive loss | | — | | | — | | | — | | | ( | | | — | | | ( | | | — |
Balance, September 30, 2026 |
| | | $ | | | $ | |
| $ | ( | | $ | ( | | $ | | | $ | — |
| | | | | | | | | | | | | | | | | | | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Senseonics Holdings, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
| | | | | |
| Nine Months Ended | ||||
| September 30, | ||||
| 2026 | | 2025 | ||
Cash flows from operating activities | | | | | |
Net loss | $ | ( | | $ | ( |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | |
Depreciation and amortization expense | | | | | |
Non-cash interest expense (debt discount and deferred costs) |
| | | | |
Net amortization of premiums and accretion of discounts on marketable securities | | ( | | | ( |
Stock-based compensation expense |
| | | | |
Provision for inventory obsolescence and losses | | ( | | | |
Allowance for credit losses | | | | | |
Other | | | | | — |
Changes in assets and liabilities: | | | | | |
Accounts receivable | | ( | | | ( |
Prepaid expenses and other current assets |
| | | | ( |
Inventory | | ( | | | ( |
Deposits and other assets | | ( | | | |
Accounts payable |
| ( | | | |
Accrued expenses and other liabilities | | | | | ( |
Payments on lease liabilities | | ( | | | ( |
Net cash used in operating activities |
| ( | | | ( |
Cash flows from investing activities | | | | | |
Capital expenditures |
| ( | | | ( |
Purchase of marketable securities | | ( | | | ( |
Proceeds from sale and maturity of marketable securities | | | | | |
Cash paid in connection with asset acquisition | | ( | | | — |
Net cash used in investing activities |
| ( | |
| ( |
Cash flows from financing activities | | | | | |
Proceeds from issuance of common stock, net | | | | | |
Proceeds from exercise of stock options, RSUs, and ESPP issuances, net | | | | | |
Proceeds from issuance of Loan and Security Agreement, net | | | | | — |
Taxes paid related to net share settlement of equity awards | | ( | | | ( |
Proceeds from issuance of common stock in Public Offering, net | | — | | | |
Proceeds from issuance of common stock in Private Placement, net | | — | | | |
Payment of debt modification costs | | — | | | ( |
Proceeds from issuance of warrants, net | | | | | — |
Repayment of 2025 Notes | | — | | | ( |
Net cash provided by financing activities |
| | |
| |
Net increase (decrease) in cash, cash equivalents, and restricted cash |
| | |
| ( |
Cash, cash equivalents, and restricted cash at beginning of period |
| | | | |
Cash, cash equivalents, and restricted cash at end of period | $ | | | $ | |
| | | | | |
Supplemental disclosure of cash flow information | | | | | |
Cash paid during the period for interest | $ | | | $ | |
Supplemental disclosure of non-cash investing and financing activities | | | | | |
Property and equipment purchases included in accounts payable and accrued expenses | | | | | |
Change in exercise price of warrants due to Amended Loan and Security Agreement | | — | | | ( |
Issuance of warrants for loan amendment | | | | | — |
Reverse stock split - reclassification from common stock to additional paid-in capital | | — | | | |
Lease liabilities arising from obtaining right-of-use assets | | | | | — |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Senseonics Holdings, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
1.Organization and Nature of Operations
Business
Senseonics Holdings, Inc., a Delaware corporation, is a medical technology company focused on the design, development and commercialization of long-term, implantable continuous glucose monitoring (“CGM”) systems to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy.
Senseonics, Incorporated is a wholly owned subsidiary of Senseonics Holdings, Inc. and was originally incorporated on October 30, 1996, and commenced operations on January 15, 1997. Eon Care Services, LLC and Eon Management Services, LLC are wholly owned subsidiaries of Senseonics, Incorporated formed in April 2024 and July 2024, respectively. In connection with the transition of commercialization activities in Italy, Germany, Spain and Sweden (the “European Territories”), the Company established wholly owned subsidiaries in the European Territories in late 2025 and early 2026 to support local commercial operations and distribution activities. Senseonics Holdings, Inc. and its consolidated subsidiaries and affiliated entities, including its consolidated variable interest entities (“VIEs”) are hereinafter collectively referred to as the “Company,” unless otherwise indicated or the context otherwise requires.
Reverse Stock Split
On October 17, 2025, at 4:05 p.m. Eastern Time (the “Effective Time”), the Company effected a 1-for-20 reverse stock split of the Company’s issued and outstanding shares of common stock (the “Reverse Stock Split”) and a proportionate reduction in the total number of authorized shares of its common stock from
Transfer to Nasdaq Stock Exchange
On November 14, 2025, the Company provided written notice to NYSE American of its determination to make a voluntary withdrawal of the Company’s common stock from the NYSE American to the Nasdaq Global Select Market (“Nasdaq”). The Company ended trading on the NYSE American effective after the market closed on November 14, 2025 and began trading on Nasdaq under the existing ticker symbol “SENS” on November 17, 2025.
Charter Amendment
At the Company’s 2026 Annual Meeting of Stockholders held on May 20, 2026, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the total number of authorized shares of common stock from
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2.Liquidity and Capital Resources
The Company has not generated significant profit from the sale of products and its ability to generate revenue and achieve profitability largely depends on the Company’s ability to successfully expand the commercialization of its implantable continuous glucose monitoring systems, including the Eversense E3 system (“Eversense E3”) and the Eversense 365 system (“Eversense 365” and, together with Eversense E3, “Eversense” or the “Eversense Systems”), continue the development of its products and product upgrades, and obtain necessary regulatory approvals or certifications for the sale of those products. These activities including the costs associated with the transition of commercial activities back to the Company (as further described in Note 4) will require significant uses of working capital through 2026 and beyond. The Company generated total net loss of $(
Several actions have been taken by the Company with regards to liquidity and to manage our cash flows for the year ended December 31, 2025 and the nine months ended September 30, 2026. These actions included, but were not limited to, the completion of multiple equity financing transactions during 2025 and 2026.
On May 4, 2026, the Company completed an underwritten public offering (the “May 2026 Offering”) of
On May 1, 2026, the Company entered into a Second Amendment to its Loan and Security Agreement with Hercules Capital, Inc. (as amended, the “Amended Loan Agreement”), pursuant to which the lenders agreed to make available to the Company up to $
During the nine months ended September 30, 2026, the Company generated approximately $
In 2025, the Company completed an underwritten public offering and private placement resulting in aggregate net proceeds of approximately $
Based on the Company’s current cash position, cash flow forecasts, and the additional financial resources obtained through the actions described above, management believes that the Company's existing cash and cash equivalents, together with anticipated cash flows, will be sufficient to fund its operations and meet its obligations as they become due for at least the next twelve months from the date these condensed consolidated financial statements are
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issued. In addition, given the Company’s historical reliance upon debt and equity financing, management will continue to evaluate our funding needs against operating performance and strategic initiatives.
3. | Summary of Significant Accounting Policies |
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP for interim financial information and the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. Although the Company considers the disclosures in these unaudited condensed consolidated financial statements to be adequate to make the information presented not misleading, certain information or footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP has been condensed or omitted as permitted under the rules and regulations of the SEC. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of financial position at September 30, 2026, and December 31, 2025, results of operations, comprehensive loss, and changes in stockholders’ equity for the three and nine months ended September 30, 2026 and 2025 and cash flows for the nine months ended September 30, 2026 and 2025 have been included. The unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 2, 2026. The interim results for September 30, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026, or for any future interim periods.
The consolidated financial statements reflect the accounts of Senseonics Holdings, Inc. and its consolidated subsidiaries and affiliated entities, including its VIEs. All intercompany balances and transactions are eliminated upon consolidation. The Company views its operations and manages its business in
In November 2024, Eon Management Services, LLC entered into management services agreements (the “Administrative Agreement”) for an initial fixed term of
In accordance with relevant accounting guidance, the Eon Care PCs are VIEs of the Company, as the Company is their primary beneficiary with the ability, through the Administrative Agreement, to direct the activities (excluding clinical activities) that most significantly affect the Eon Care PCs’ financial performance and has the obligation to absorb losses of, or the right to receive benefits from, the Eon Care PCs that could potentially be significant to it. The assets of the consolidated VIEs may only be used to settle obligations of the consolidated VIEs, if any. The VIEs’ assets, liabilities, and results of operations were not material to our consolidated financial results.
Significant Accounting Policies
The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 3 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
Recent Accounting Pronouncements
In November 2024, the FASB issued Accounting Standards Update No. 2024-03, Disaggregation of Income Statement Expenses (DISE) (“ASU 2024-03”), the objective of which is to provide greater transparency about an entity’s
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expenses to allow investors to better understand an entity’s performance, assess its prospects for future cash flows, and compare its performance both over time and with that of other entities. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company is currently evaluating the impact of the new standard on its financial statements and disclosures.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses during the reporting period. In the accompanying unaudited condensed consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, recoverability of long-lived assets and definite-lived intangible assets, deferred taxes and valuation allowances, fair value of investments, obsolete inventory, warranty obligations, variable consideration related to revenue, allowance for credit losses, depreciable lives of property and equipment, amortization periods for identifiable intangible assets, and accruals for clinical study costs, which are accrued based on estimates of work performed under contract. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that it believes are reasonable, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recorded revenues and expenses. Actual results could differ from those estimates; however, management does not believe that such differences would be material.
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4.Revenue Recognition
The Company generates product revenue from sales of the Eversense system and related components and supplies to strategic fulfillment partners and through its consignment network in the United States, as well as to Ascensia Diabetes Care Holdings AG (“Ascensia”), third-party distributors and hospital systems outside the United States (each, a “Customer” and collectively “Customers”), who then resell the products to health care providers and patients. Effective January 1, 2026, in connection with the parties’ execution of a Master Asset Purchase Agreement on December 31, 2025 (the “Master Asset Purchase Agreement”), the Company reassumed primary commercialization responsibilities in the United States and began marketing and distributing Eversense products through its own sales force and strategic fulfillment partner network. In March 2026, the Company executed separate European local asset purchase agreements for Italy, Germany, Spain, and Sweden and in the second quarter assumed primary commercialization responsibilities in Spain and Sweden, and in Germany in August 2026. During the third quarter of 2026, the Company also assumed primary commercialization responsibilities for substantially all activities in Italy. In Italy, Ascensia continues to provide certain transition support services to facilitate the orderly transition of commercial operations in the market.
The Company is paid for its sales directly to the Customers, regardless of whether the Customers resell the products to health care providers and patients. The Company also generates product revenue from sales of the Eversense system and related components and supplies through a consignment model with its network of independent healthcare professionals in the United States and revenue is recognized when the product is consumed by a patient. The Company’s policies for recognizing sales have not changed from those described in its Annual Report on Form 10-K for the year ended December 31, 2025.
Revenue by Geographic Region
The following table sets forth net revenue derived from the Company’s
| | | | | | | | | | | |
| Three Months Ended | | | Nine Months Ended | | ||||||
| September 30, 2026 | | | September 30, 2026 | | ||||||
| | | % | | | | | % | | ||
(Dollars in thousands) | Amount | | of Total | | | Amount | | of Total | | ||
Revenue, net: | | | | | | | | | | | |
United States | $ | | | % | | $ | | | % | ||
Outside of the United States | | | | | | | | | | ||
Total | $ | | | % | | $ | | | % | ||
| | | | | | | | | | | |
| Three Months Ended | | | Nine Months Ended | | ||||||
| September 30, 2025 | | | September 30, 2025 | | ||||||
| | | % | | | | | % | | ||
(Dollars in thousands) | Amount | | of Total | | | Amount | | of Total | | ||
Revenue, net: | | | | | | | | | | | |
United States | $ | | | % | | $ | | | % | ||
Outside of the United States | | | | | | | | | | ||
Total | $ | | | % | | $ | | | % | ||
Contract Assets
Contract assets consist of unbilled receivables from Customers and are recorded at net realizable value. Included in accounts receivable, net as of September 30, 2026 and December 31, 2025 are unbilled accounts receivable of $
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2025, which is related to revenue share variable consideration from the Commercialization Agreement. The Company expects to invoice and collect all unbilled accounts receivable within twelve months.
Concentration of Revenue and Customers
Historically, a significant portion of the Company’s revenue was derived from one Customer, Ascensia, the Company’s former global commercialization partner. Following the Company’s transition of commercial operations from Ascensia, the Company now sells directly to its Customers. For the three months ended September 30, 2026 and 2025, sales to Ascensia accounted for
A portion of the Company’s revenue is earned via consignment arrangements with healthcare providers. For the three months ended September 30, 2026 and 2025, sales under consignment arrangements accounted for
Termination and Modification of Commercialization Arrangements
On September 3, 2025, the Company and Ascensia entered into a memorandum of understanding related to the transition of commercial operations for Eversense from Ascensia back to the Company. On December 31, 2025, the parties executed a Master Asset Purchase Agreement and effective January 1, 2026 the parties entered into an Amended and Restated Collaboration and Commercialization Agreement (the “A&R Commercialization Agreement”), which terminated Ascensia’s rights to market Eversense products in the United States and made Ascensia’s European commercialization rights non-exclusive.
Following the A&R Commercialization Agreement, Ascensia has no further rights to revenues from sales of Eversense products in the United States, and effective January 1, 2026, the Company is entitled to 100% of revenues from sales in the European Territories, subject to transitional arrangements. In connection with the transition of U.S. commercialization activities, the Company entered into agreements with certain U.S. strategic fulfillment partners that previously distributed products on behalf of Ascensia, consistent with the Company’s historical distribution relationships.
As a result of the termination and modification of the arrangement, the Company reassessed its remaining performance obligations and adjusted related contract assets and contract liabilities in accordance with ASC 606. In connection with the termination, the Company accepted the return of certain unsold inventory previously held by Ascensia, reversed $
Additional information regarding the Master Asset Purchase Agreement and related transactions is included in Note 17 — Related Party Transactions.
5.Net Loss per Share
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. An aggregate of
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and the May 2026 Pre-Funded Warrants (as defined below) are included in the number of outstanding shares used for the computation of basic net loss per share for the periods in which they were outstanding. The May 2026 Pre-Funded Warrants were issued in May 2026 and, accordingly, are included only for the three and nine months ended September 30, 2026. Since the shares are issuable for little or no consideration, sometimes referred to as “penny warrants,” they are considered outstanding in the context of earnings per share, as discussed in ASC 260-10-45-13.
Diluted net loss per share is computed using the weighted average number of common shares outstanding during the period and, when dilutive, potential common share equivalents. Potentially dilutive common shares consist of shares issuable from restricted stock units (“RSUs”), stock options, warrants and the Company’s convertible notes. Potentially dilutive common shares issuable upon vesting of restricted stock units, exercise of stock options and exercise of warrants are determined using the average share price for each period under the treasury stock method. Potentially dilutive common shares issuable upon conversion of the Company’s convertible notes are determined using the if-converted method. The if-converted method assumes conversion of convertible securities at the beginning of the reporting period. Interest expense, dividends, and the changes in fair value measurement recognized during the period are added back to the numerator. The denominator includes the common shares issuable upon conversion of convertible securities.
In periods of net loss, all potentially dilutive common shares are excluded from the computation of the diluted net loss per share for those periods, as the effect would be anti-dilutive.
The following table sets forth the computation of basic and diluted net loss per share for the periods shown:
(Dollars, in thousands, except per-share amounts)
| | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, | ||||
| | 2026 | | 2025 | | 2026 | | 2025 |
Net loss | $ | ( | $ | ( | $ | ( | $ | ( |
Basic weighted average common shares outstanding | | | | | | | | |
Net loss per share: | | | | | | | | |
Basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( |
Outstanding anti-dilutive securities not included in the diluted net loss per share calculations were as follows:
| | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, | ||||
| | 2026 | | 2025 | | 2026 | | 2025 |
Stock-based awards | | | | | | | | |
Warrants | | | | | | | | |
Total anti-dilutive shares outstanding | | | | | | | | |
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6. | Composition of Certain Financial Statement Items |
Cash, Cash Equivalents, and Restricted Cash
Cash, cash equivalents, and restricted cash consisted of the following (in thousands):
| | | | | | | |
| | September 30, | | December 31, | |||
| | 2026 | | 2025 | |||
| Cash | | $ | | | $ | |
| Money market funds | | | | | | |
| Restricted Cash | | | | | | |
| Total cash, cash equivalents, and restricted cash | | $ | | | $ | |
The Company’s restricted cash relates to collateral for procurement cards issued by a U.S. commercial bank.
Accounts receivable, net
Accounts receivable, net consisted of the following (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Accounts receivable | | $ | | | $ | |
Accounts receivable - related parties | | | — | | | |
Less: allowance for credit losses | | | ( | | | ( |
Total accounts receivable, net | | $ | | | $ | |
Inventory, net
Inventory, net of reserves, consisted of the following (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Finished goods | | $ | | | $ | |
Work-in-process | |
| | |
| |
Raw materials | |
| | |
| |
Total | | $ | | | $ | |
The Company charged $
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Property, equipment and intangible assets, net
Property, equipment and intangible assets, net, consisted of the following (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Property and equipment | | | | | | |
Machinery and laboratory equipment | | $ | | | $ | |
Office furniture and equipment | | | | | | |
Leasehold improvements | |
| | |
| |
Intangible assets | | | | | | |
Sensor insertion network assets | | | | | | |
Less: Accumulated depreciation and amortization | |
| ( | |
| ( |
Property, equipment and intangible assets, net | | $ | | | $ | |
7. | Marketable Securities |
Marketable securities available for sale were as follows (in thousands):
| | | | | | | | | | | | |
| | September 30, 2026 | ||||||||||
| | | | Gross | | Gross | | Estimated | ||||
| | Amortized | | Unrealized | | Unrealized | | Market | ||||
| | Cost | | Gains | | Losses | | Value | ||||
Commercial Paper | | $ | | | $ | — | | $ | ( | | $ | |
Corporate debt securities | | | | | | — | | | ( | | | |
Government and agency securities | | | | | | — | | | ( | | | |
Total | | $ | | | $ | — | | $ | ( | | $ | |
| | | | | | | | | | | | |
| | December 31, 2025 | ||||||||||
| | | | Gross | | Gross | | Estimated | ||||
| | Amortized | | Unrealized | | Unrealized | | Market | ||||
| | Cost | | Gains | | Losses | | Value | ||||
Commercial Paper | | $ | | | $ | | | $ | — | | $ | |
Corporate debt securities | | | | | | | | | — | | | |
Government and agency securities | | | | | | | | | — | | | |
Total | | $ | | | $ | | | $ | — | | $ | |
The following are the scheduled maturities as of September 30, 2026 (in thousands):
| | | | | | |
| | Net | | Fair | ||
| | Carrying Amount | | Value | ||
2026 (remaining three months) | | $ | | | $ | |
2027 | | | | | | |
Total | | $ | | | $ | |
The Company periodically reviews its portfolio of debt securities to determine if any investment is impaired due to credit loss or other potential valuation concerns. For debt securities where the fair value of the investment is less than the amortized cost basis, the Company assesses at the individual security level, for various quantitative factors including, but not limited to, the nature of the investments, changes in credit ratings, interest rate fluctuations, industry analyst reports, and the severity of impairment. Unrealized losses on available-for-sale securities at September 30, 2026 were not significant and were primarily due to changes in interest rates and not due to increased credit risk associated with specific securities. The Company does not intend to sell these impaired investments and it is not more likely than not that
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the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
8. | Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consisted of the following (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Contract manufacturing(1) | | $ | | | $ | |
IT and software | | | | | | |
VAT receivables | | | | | | — |
Interest receivable | | | | | | |
Sales and marketing | | | | | | |
Clinical and Preclinical | |
| | |
| |
Other | | | | | | |
Total prepaid expenses and other current assets | | $ | | | $ | |
| (1) | Includes deposits to contract manufacturers for the manufacturing process. |
9. | Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities (including related party amounts) consisted of the following (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Compensation and benefits | | $ | | | $ | |
Research and development | | | | | | |
Patient access and incentive programs | | | | | | — |
Contract manufacturing | |
| | |
| |
Sales and marketing services | | | | | | |
Professional and administrative services | | | | | | |
Operating lease | |
| | |
| |
Other | | | | | | |
Total accrued expenses and other current liabilities | | $ | | | $ | |
10. | Leases |
The Company leases approximately
headquarters under a non-cancelable operating lease. The Company has
The Company also leases dedicated office space in Germany, Italy, and Sweden under agreements with terms of 12 months. The Company has elected not to recognize right-of-use (“ROU”) assets and lease liabilities for leases with a term of 12 months or less, and recognizes payments under these arrangements as expense on a straight-line basis over the lease term.
Effective January 1, 2026, in connection with the acquisition of certain U.S. commercial assets under the Master Asset Purchase Agreement with Ascensia, the Company assumed operating leases for a fleet of vehicles used by its U.S. sales force, with original expirations ranging from May 31, 2028 to June 30, 2030.
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Fleet Wind-Down
In July 2026, the Company committed to a plan to transition its field employees to a vehicle reimbursement program and to exit the fleet leases through the return of the vehicles to the lessor for sale or their purchase by the assigned employees by December 31, 2026. As a result, the Company tested the related ROU assets for impairment as of July 1, 2026 and recognized an impairment loss of $
Lease Cost
Operating lease cost is recognized on a straight-line basis over the lease term. Operating lease cost was $
The rent expense is recognized on a straight-line basis through the end of the lease term, excluding option renewals. The difference between the straight-line rent amounts and amounts payable under the lease is recorded as deferred lease cost.
The following table summarizes the lease assets and liabilities as of September 30, 2026 and December 31, 2025 (in thousands):
| | | | | | | | |
| | | | | | September 30, | | December 31, |
Operating Lease Assets and Liabilities | | Balance Sheet Classification | | 2026 | 2025 | |||
Assets | | | | | | | | |
Operating lease ROU assets | | | Deposits and other assets | | $ | | $ | |
Liabilities | | | | | | | | |
Current operating lease liabilities | | | Accrued expenses and other current liabilities | | $ | | $ | |
Non-current operating lease liabilities | | | Non-current operating lease liabilities | | | | | |
Total operating lease liabilities | | | | | $ | | $ | |
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The following table summarizes the maturity of undiscounted payments due under operating lease liabilities and the present value of those liabilities as of September 30, 2026 (in thousands):
| | | |
2026 (remaining 3 months) | | $ | |
2027 | | | |
2028 | | | |
2029 | | | |
2030 | | | |
Thereafter | | | |
Total | | | |
Less: Present value adjustment | | | ( |
Present value of lease liabilities | | $ | |
The following table summarizes the weighted-average lease term and weighted-average discount rate as of September 30, 2026:
| | | |
Remaining lease term (years) | | 2026 | |
Operating leases | | | |
Discount rate | | | |
Operating leases | | % | |
| | | |
11. | Product Warranty Obligations |
The Company provides a warranty of
The following table provides a reconciliation of the change in estimated warranty liabilities for the nine months ended September 30, 2026, and for the twelve months ended December 31, 2025 (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
Balance at beginning of the period | | $ | | | $ | |
Provision for warranties during the period | | | | | | |
Settlements made during the period | | | ( | | | ( |
Balance at end of the period | | $ | | | $ | |
12. | Notes Payable, Preferred Stock and Stock Purchase Warrants |
Term Loans
Loan and Security Agreement
On September 8, 2023 (the “Effective Date”), the Company entered into a loan agreement (the “Loan and Security Agreement”) with Hercules Capital, Inc. and its managed fund (collectively, the “Lenders”), pursuant to which the Lenders agreed to make available to Senseonics up to $
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Date”), the Company entered into the Amended Loan and Security Agreement with the Lenders and Hercules. The Amended Loan and Security Agreement increased the total loan commitment under the facility from $
On May 1, 2026, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) with the Lenders and Hercules, which further amended the Amended Loan and Security Agreement. Pursuant to the Second Amendment, the Lenders agreed to make available to the Company up to $
The loans under the Amended Loan Agreement, as modified by the Second Amendment, bear interest at an annual rate equal to the greater of (i) the prime rate as reported in The Wall Street Journal plus
At the Company’s option, the Company may prepay all or any portion of the outstanding borrowings under the Amended Loan and Security Agreement, subject to a prepayment fee equal to (a)
The Company’s obligations under the Amended Loan and Security Agreement are secured by a first-priority security interest in substantially all of its assets. The Amended Loan and Security Agreement contains a minimum cash covenant that requires the Company to hold unrestricted cash equal to
In addition, the Amended Loan and Security Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens,
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investments, mergers, corporate changes, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. The Amended Loan and Security Agreement also contains events of default including, among other things, payment defaults, breach of covenants, material adverse effect, breach of representations and warranties, cross-default to material indebtedness, bankruptcy-related defaults, judgment defaults, revocation of certain government approvals, and the occurrence of certain adverse events. Following an event of default and any applicable cure period, a default interest rate equal to the then-applicable interest rate plus
In addition, in connection with the issuance of the Tranche 1 Loan, the Company issued warrants to the Lenders (collectively, the “Tranche 1 Warrants”) to acquire an aggregate of
In connection with the funding of the 2026 Tranche 2 Loan and the 2026 Tranche 3A Loan under the Second Amendment to the Loan and Security Agreement, the Company issued warrants to purchase an aggregate of
In connection with the Loan and Security Agreement, the Company incurred $
Convertible Notes
2025 Notes
In July 2019, the Company issued $
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Over the term of the 2025 Notes, the Company completed a series of exchanges and conversions that reduced the outstanding principal balance, including (i) the settlement of $
Following these transactions, approximately $
The following carrying amounts are outstanding under the Company’s notes payable as of September 30, 2026 and December 31, 2025 (in thousands):
| | | | | | | |
| September 30, 2026 | ||||||
| Principal ($) | | Debt (Discount) Premium ($)⁽¹⁾ | | Issuance Costs ($) | | Carrying Amount ($) |
Amended Loan and Security Agreement | | | | | ( | | |
| | | | | | | |
| December 31, 2025 | ||||||
| Principal ($) | | Debt (Discount) Premium ($)⁽¹⁾ | | Issuance Costs ($) | | Carrying Amount ($) |
Amended Loan and Security Agreement | | | | | ( | | |
| | | | | | | |
| (1) | Includes accretion of end of term fees, including $ |
As of September 30, 2026, $
Interest expense related to the notes payable for the periods presented below is as follows (in thousands):
| | | | | | | | | |
| Nine Months Ended September 30, 2026 | ||||||||
| Interest Rate | | Interest ($) | | Debt Discount and Fees ($)⁽¹⁾ | | Issuance Costs ($) | | Total Interest Expense ($) |
Amended Loan and Security Agreement | | | | | | | | | |
Total | | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Nine Months Ended September 30, 2025 | ||||||||
| Interest Rate | | Interest ($) | | Debt Discount and Fees ($)⁽¹⁾ | | Issuance Costs ($) | | Total Interest Expense ($) |
2025 Notes | | | | | | | | | |
Loan and Security Agreement | | | | | | | | | |
Amended Loan and Security Agreement | | | | | | | | | |
Total | | | | | | | | | |
| (1) | Includes accretion of end of term fees, including $ |
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The following are the scheduled maturities of the Company’s notes payable (including end of term fees) as of September 30, 2026 (in thousands):
| | | |
2027 | | $ | |
2028 | | | |
2029 | | | |
Total | | $ | |
13. | Stockholders’ Equity |
Public and Registered Direct Offerings
On May 15, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with several underwriters for the sale of
On April 30, 2026, the Company entered into an underwriting agreement (the “April 2026 Underwriting Agreement”) with TD Securities (USA) LLC and Barclays Capital Inc., as representatives of the several underwriters named therein, pursuant to which the Company agreed to issue and sell an aggregate of
ATM Offerings
On August 6, 2025, the Company entered into an at-the-market sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”), under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $
In August 2023, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Goldman Sachs & Co. LLC (“GS”), under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $
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as its sales agent in an “at the market” offering. GS received commissions up to
Stock Purchase Warrants
The table below summarizes the warrant activity for the nine months ended September 30, 2026. This table does not include the PHC Exchange Warrant (as defined below), the PHC Purchase Warrant (as defined below) or the May 2026 Pre-Funded Warrants (as defined above). Such warrants are pre-funded and excluded from the table due to their nominal exercise prices of $
| | | | | | | | |
| | Shares | | | Exercise price (per share) | | | Weighted average exercise price (per share) |
Outstanding, December 31, 2025 | | | $ | | $ | | ||
Granted | | | | | | | | |
Exercised | | | | | | | | — |
Expired | | ( | | $ | 5.0167 to $47.60 | | $ | |
Outstanding and Exercisable, September 30, 2026 | | | $ | | $ | | ||
| | | | | | | | |
Weighted Average Remaining Life, September 30, 2026 (years) | | | | | | | | |
Weighted Average Remaining Life, Exercisable, September 30, 2026 (years) | | | | | | | |
On June 30, 2016, we entered into a loan agreement with Oxford Finance and Silicon Valley Bank (collectively, the “Lenders”) and issued to the Lenders 10-year stock purchase warrants to purchase
On March 13, 2023, we issued and sold to PHC a warrant to purchase
In March 2023, we entered into an exchange agreement with PHC, pursuant to which PHC exchanged $
On September 8, 2023, we entered into the Loan and Security Agreement with several lenders and issued the Tranche 1 Warrants to acquire an aggregate of
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the Company and the lenders entered into an amendment to reduce the exercise price to $
On January 2, 2024, we issued the Tranche 2 Warrants to acquire an aggregate of
On October 24, 2024, in connection with a registered direct securities offering, the Company issued to the investors in the offering warrants to purchase an aggregate of
On May 6, 2026, we closed the Second Amendment to the Amended Loan and Security Agreement with several lenders and issued the 2026 Warrants to acquire an aggregate of
On May 4, 2026, in connection with the May 2026 Offering, we issued pre-funded warrants to purchase an aggregate of
14. | Stock-Based Compensation |
2015 Plan
In December 2015, the Company adopted the 2015 Equity Incentive Plan (the “2015 Plan”), under which incentive stock options, non-qualified stock options and restricted stock units may be granted to the Company’s employees and certain other persons, such as officers and directors, in accordance with the 2015 Plan provisions. In February 2016, the Company’s Board of Directors adopted, and the Company’s stockholders approved, an Amended and Restated 2015 Equity Incentive Plan (the “Amended and Restated 2015 Plan”), which became effective on February 20, 2016. The Company’s Board of Directors may terminate the Amended and Restated 2015 Plan at any time. Options granted under the Amended and Restated 2015 Plan expire
Pursuant to the Amended and Restated 2015 Plan, the number of shares of the Company’s common stock reserved for issuance automatically increases on January 1 of each year, ending on January 1, 2026, by
Commercial Equity Plan
On January 30, 2023, the Company adopted the Senseonics Holdings, Inc. 2023 Commercial Equity Plan (the “Commercial Equity Plan”), pursuant to which the Company reserved
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non-statutory options and restricted stock unit awards. In May 2026, the Commercial Equity Plan was superseded by the 2026 Plan; no new awards will be granted under the existing plan, outstanding awards will remain in effect under its terms, and the Commercial Equity Plan’s unallocated shares rolled into the 2026 Plan.
2026 Plan
In May 2026, the Company’s Board of Directors adopted, and the Company’s stockholders approved the 2026 Plan, pursuant to which the Company reserved
Inducement Plan
On May 30, 2019, the Company adopted the Senseonics Holdings, Inc. Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved
2016 Employee Stock Purchase Plan
In February 2016, the Company adopted the 2016 Employee Stock Purchase Plan (the “2016 ESPP”). The 2016 ESPP became effective on March 17, 2016. The maximum number of shares of common stock that may be issued under the 2016 ESPP was initially
The 2016 ESPP permits participants to purchase shares of the Company’s common stock through payroll deductions of up to
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15. | Fair Value Measurements |
The following table represents the fair value hierarchy of the Company’s financial assets and liabilities measured at fair value on a recurring basis at September 30, 2026 and December 31, 2025 (in thousands):
| | | | | | | | | | | | | |
| | September 30, 2026 |
| ||||||||||
Asset Class | | Total | | Level 1 | | Level 2 | | Level 3 |
| ||||
Cash and Cash Equivalents⁽¹⁾ | | | | | | | | | | | | | |
Money market funds | | $ | | | | | | | — | | | — | |
Short Term Investments | | | | | | | | | | | | | |
Commercial paper (>3 months) | | $ | | | | — | | | | | | — | |
Corporate debt securities | | | | | | — | | | | | | — | |
Government and agency securities (>3 months) | | | | | | | | | — | | | — | |
Foreign corporate/sovereign debt securities | | | | | | — | | | | | | — | |
| | | | | | | | | | | | | |
| | December 31, 2025 |
| ||||||||||
Asset Class | | Total | | Level 1 | | Level 2 | | Level 3 |
| ||||
Cash and Cash Equivalents⁽¹⁾ | | | | | | | | | | | | | |
Money market funds | | $ | | | | | | | — | | | — | |
Short Term Investments | | | | | | | | | | | | | |
Commercial paper (>3 months) | | $ | | | | — | | | | | | — | |
Corporate debt securities | | | | | | — | | | | | | — | |
Government and agency securities (>3 months) | | | | | | | | | — | | | — | |
| (1) | Classified as cash and cash equivalents due to their short-term maturity. |
16. | Income Taxes |
The Company has
17.Related Party Transactions
PHC has a noncontrolling ownership interest in the Company. In addition, PHC previously appointed two members on the Company’s board of directors (which appointment was terminated on January 1, 2026). The Company previously entered into a financing agreement with PHC on August 9, 2020. Ascensia is a related party through the ownership interests of its parent company, PHC.
Revenue from Ascensia during the nine months ended September 30, 2026 and 2025 was $
As of September 30, 2026, there was
As discussed in Note 4, on September 3, 2025 the Company and Ascensia signed a memorandum of understanding (“MOU”) related to the transition of commercial operations for Eversense from Ascensia back to the Company. On December 31, 2025, the parties executed a Master Asset Purchase Agreement, pursuant to which the Company acquired certain U.S. commercial assets and assumed certain related liabilities, with the initial closing on January 1, 2026. In connection with the Master Asset Purchase Agreement, the parties entered into an A&R
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Commercialization Agreement, which terminated Ascensia’s rights to market Eversense products in the United States and modified Ascensia’s commercialization rights in the European Territories. The parties are cooperating during a defined transition period to ensure continuity of supply, customer support, and patient access. In connection with this transition, the Company hired certain sales and support personnel previously engaged by the counterparty.
The Company paid total consideration of approximately $
As contemplated by the Master Asset Purchase Agreement, on March 12, 2026, the parties entered into separate local asset purchase agreements (the “Local Purchase Agreements”) covering the European Territories, pursuant to which the Company agreed to acquire certain additional commercial assets (the “European Purchased Assets”) and assume certain related liabilities (the “European Assumed Liabilities” and together with the European Purchased Assets, the “European Asset Purchases”) in those territories. The closings of these transactions (the “European Closings”) occurred in early June 2026. In Italy, Ascensia continues to provide certain transition support services to facilitate the orderly transition of commercial operations in the market. In connection with the European Closings, the Company accepted the return of certain unsold inventory previously held by Ascensia, reversed $
In connection with the Local Purchase Agreements, the parties also entered into a Transition Services Agreement (the “Transition Services Agreement”) under which Ascensia will provide certain operational and administrative support services in the European Territories during the transition period, including support in the areas of logistics and ordering, payment and collections, claims processing, IT and systems migration, personnel support, finance and operations support, regulatory compliance, and other agreed services, for which the Company will pay certain costs and service fees. The Company incurred approximately $
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18.Segment Information
The Company views its operations and manages its business in
The CODM assesses performance for the segment based on net loss, which is reported in the consolidated statements of operations and comprehensive loss, and uses the financial information in deciding how to invest in the Company. The measure of segment assets is reported on the balance sheets as total assets.
The table below summarizes the significant expense categories regularly reviewed by the CODM for the three and nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | |
| Three Months Ended | | Nine Months Ended | ||||||||
| September 30, | | September 30, | ||||||||
| | 2026 | | | 2025 | | | 2026 | | | 2025 |
Total revenue | $ | | | $ | | | $ | | | $ | |
Less: | | | | | | | | | | | |
Cost of sales | | | | | | | | | | | |
Sales and marketing expenses |
| | |
| | | | | |
| |
Research and development expenses |
| | |
| | | | | |
| |
General and administrative expenses | | | | | | | | | | | |
Other Segment Items(1) | | | | | ( | | | | | | |
Net Loss | $ | ( | | $ | ( | | $ | ( | | $ | ( |
| (1) |
19.Subsequent Events
The Company has evaluated all subsequent events through the filing date of this Form 10-Q with the SEC, to ensure that this filing includes appropriate disclosure of events both recognized in the financial statements as of September 30, 2026, and events which occurred subsequently but were not recognized in the financial statements. There were no subsequent events which required recognition, adjustment to or disclosure in the financial statements.
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ITEM 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “plan,” “project,” “expect,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks, uncertainties, and assumptions, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those described below and elsewhere in this Quarterly Report on Form 10-Q, and in our Annual Report on Form 10-K, particularly in Part I – Item 1A, “Risk Factors,” and our other filings with the Securities and Exchange Commission. Statements made herein are as of the date of the filing of this Quarterly Report on Form 10-Q with the Securities and Exchange Commission and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related notes for the year ended December 31, 2025, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 2, 2026. Unless otherwise indicated or the context otherwise requires, all references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to Senseonics Holdings, Inc. and its consolidated subsidiaries and affiliated entities, as appropriate, including its consolidated VIEs.
Unless otherwise indicated, all information in this Quarterly Report on Form 10-Q gives effect to a 1-for-20 reverse stock split of our common stock that became effective on October 17, 2025 (the “Reverse Stock Split”), and all references to historical share and per share amounts give effect to the Reverse Stock Split.
Overview
We are a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Our implantable CGM systems, including the Eversense E3 system (“Eversense E3”) and the Eversense 365 system (“Eversense 365” and, together with Eversense E3, “Eversense” or the “Eversense 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 six months in the case of Eversense E3 and up to twelve months in the case of Eversense 365, as compared to seven to 15 days for non-implantable CGM systems. As described in more detail below, in August 2020, we entered into a collaboration and commercialization agreement (the “Existing Commercialization Agreement” or the “Commercialization Agreement”) with Ascensia Diabetes Care Holdings AG (“Ascensia”) pursuant to which we granted Ascensia the exclusive right to distribute Eversense worldwide, with certain initial exceptions. In February 2022, Eversense E3, a 180 day CGM system, was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States in the second quarter of 2022. In June 2022, we affixed the CE Mark to the extended life Eversense E3 system and Ascensia began commercialization in select markets in Italy, Germany, Spain and Sweden (the “European Territories”) during the third quarter of 2022. In September 2024, Eversense 365, a 365-day extended life CGM system, was approved by the FDA and Ascensia began commercializing Eversense 365 in the United States in the fourth quarter of 2024. In January 2026, we took over full commercial responsibility for Eversense 365 in the United States and began marketing and distributing the product with our own sales force. In January 2026, we also obtained CE Mark approval for Eversense 365 and have since launched Eversense 365 in the European Territories on a phased basis. As of September 30, 2026, the substantial majority of our European
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customers had transitioned to Eversense 365, and we expect the remaining customers to transition over the coming months.
On September 3, 2025 the Company and Ascensia signed a memorandum of understanding (“MOU”) related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company. On December 31, 2025, the parties entered into the Master Asset Purchase Agreement formalizing this transfer, closed these transactions in the U.S. on January 1, 2026, and entered into the A&R Commercialization Agreement, which terminated Ascensia’s right to market Eversense products in the U.S. and rendered Ascensia’s right to market Eversense products in the European Territories non-exclusive. Pursuant to the A&R Commercialization Agreement, effective January 1, 2026, we are entitled to 100% of the revenues derived from the sale of Eversense products in the European Territories. As contemplated by the Master Asset Purchase Agreement, on March 12, 2026 we entered into local asset purchase agreements to facilitate the transition of Ascensia’s commercialization activities in the European Territories. The Company and Ascensia also entered into a Transition Services Agreement, under which the Company paid Ascensia for certain support and administrative services in Europe during 2026. The European transactions closed in early June 2026. Ascensia continues to provide certain transition support services, particularly related to Italy, to facilitate an orderly transition of the commercialization activities in the market following the closings.
Our net revenues are derived from sales of the Eversense CGM system which includes the Eversense Sensor Pack containing the sensor, insertion tool, and adhesive patches, the Eversense Smart Transmitter Pack containing the transmitter and charger and in some cases the procedure revenue associated with insertions and removals.
In the United States, we sell directly to our network of distributors and strategic fulfillment partners, who provide the Eversense system to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement. In addition, we sell our product through a consignment model through arrangements with our network of healthcare professionals. In Europe, we sell primarily to hospital networks under tender agreements and through distributors, who resell the Eversense systems to hospitals. Sales of the Eversense system are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party payors or government agencies. We leverage and target regions where we have coverage decisions for patient device use and provider insertion and removal procedure payment. We have reached approximately 300 million covered lives in the United States through positive insurance payor coverage decisions. In June 2023, we received positive payor coverage decision from UnitedHealthcare, the largest healthcare insurance company in the United States that effective July 1, 2023, Eversense E3 would be covered. On August 3, 2020, the Center for Medicare and Medicaid Services (“CMS”) released its Calendar Year 2021 Medicare Physician Fee Schedule Proposed Rule that announces proposed policy changes for Medicare payments, including the proposed establishment of national payment amounts for the three CPT© Category III codes describing the insertion (CPT 0446T), removal (0447T), and removal and insertion (0448T) of an implantable interstitial glucose sensor, which describes our Eversense Systems, as a medical benefit, rather than as part of the Durable Medical Equipment channel that includes other CGMs. In December 2021, CMS released its Calendar Year 2022 Medicare Physician Fee Schedule that updated bundled payments for the device cost and procedure fees. In November 2022, CMS released its Calendar Year 2023 Medicare Physician Fee Schedule Proposed Rule that updates the payment amounts for the three CPT© III codes to account for the longer 6-month sensor. In February 2024, we announced that Medicare coverage was expanded for Eversense E3 to include all people with diabetes using insulin and non-insulin users who have a history of problematic hypoglycemia providing access to millions of Medicare patients. In April 2025, CMS updated the payment amounts in the Physician Fee Schedule to account for the longer duration Eversense 365 for all eligible Medicare beneficiaries. The Physician Fee Schedule was updated with similar pricing for 2026. We have been working with payors that previously supported Eversense to transition their policies to Eversense 365 and the majority of these eligible payors have now completed that transition.
In February 2020, we announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor. This sub-set of 30 participants was left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days. Information gathered from this sub-set and additional development efforts provided us the confidence to start the ENHANCE pivotal study of Eversense 365. The ENHANCE pivotal study of Eversense 365 completed enrollment, the last patient of the adult cohort completed the study, and we completed our analysis of the data. Based on this analysis, we determined to advance to the next generation sensor platform as the underlying technology used in the 365-day and
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future products. In May 2024, this data supported an FDA 510(k) submission for a new product with a 365-day duration and once per week calibration. The 510(k) submission was approved by the FDA on September 17, 2024 and Eversense 365 was cleared for sale in the United States.
We continue to expand commercialization of the Eversense brand and are focused on driving awareness of our CGM system among people with diabetes and their healthcare providers. Effective January 1, 2026, U.S. commercialization activities were returned to us. In March 2026, we executed separate European local asset purchase agreements for Italy, Germany, Spain, and Sweden. We assumed primary commercialization responsibilities in Spain and Sweden in June 2026 and in Germany in August 2026. During the third quarter of 2026, we also assumed primary commercialization responsibilities for substantially all activities in Italy. Ascensia continues to provide limited transition support in Italy to facilitate the orderly transition of commercial operations in that market, including collaborating on efforts to finalize the transfer of remaining Italian tender contracts. As a result of these transitions, revenue outside the United States in the third quarter of 2026 increasingly reflects direct sales to distributors, hospital systems and other customers at local market pricing, rather than sales to Ascensia.
In both the United States and our overseas markets we will commercialize the products with direct sales forces and distribution systems that market and promote our various Eversense Systems and future generation products, including our Gemini and Freedom product variations. The Gemini product will allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and flash glucose monitoring, in an implantable sensor with battery that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over the sensor with a smartphone to get an on-demand glucose reading without a smart transmitter. Our Freedom product variation is being designed to include Bluetooth in the sensor, eliminating the on-body component.
United States Development and Commercialization of Eversense
In 2016, we completed our PRECISE II pivotal clinical trial in the United States. This trial, which was fully enrolled with 90 subjects, was conducted at eight sites in the United States. In the trial, we measured the accuracy of the Eversense 90 system (“Eversense 90”) measurements through 90 days after insertion. We also assessed safety through 90 days after insertion or through sensor removal. In the trial, we observed a mean absolute relative difference (“MARD”), of 8.5% utilizing two calibration points for Eversense 90 across the 40-400 mg/dL range when compared to YSI blood reference values during the 90-day continuous wear period. Based on the data from this trial, in October 2016 we submitted a pre-market approval (“PMA”) application to the FDA to market Eversense 90 in the United States for 90-day use. In June 2018, we received PMA approval from the FDA for the Eversense 90 system. In July 2018, we began distributing the 90-day Eversense 90 system directly in the United States through our own direct sales and marketing organization. We have received Category III CPT codes for the insertion and removal of the Eversense 90 sensor.
In December 2018, we initiated the PROMISE pivotal clinical trial to evaluate the safety and accuracy of Eversense 90 for a period of up to six months in the United States and on September 30, 2019, we completed enrollment of the PROMISE trial. In the trial, we observed performance matching that of the then current Eversense 90 available in the United States, with a MARD of 8.5%. This result was achieved with reduced calibration, down to one per day, while also doubling the sensor life to six months. Following the results of the PROMISE trial, on September 30, 2020, a PMA supplement application to extend the wearable life of Eversense 90 to six months was submitted to the FDA. In February 2022, the extended life Eversense E3 was approved by the FDA.
On February 26, 2020, we announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor. This sub-set of 30 participants was left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days. Information gathered from this sub-set and additional development efforts provided us with the confidence to start the Pivotal study for Eversense 365.
In April 2020, we announced that we received an extension to our CE Certificate of Conformity in the EEA such that the Eversense XL is no longer contraindicated for MRI, which means the sensor does not need to be removed from under the skin during MRI scanning. We had previously obtained this indication for Eversense 90 in the United
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States in 2019. This MRI approval is a first for the CGM category, as all other sensors are required to be removed during an MRI scan.
On August 9, 2020, we entered into the Commercialization Agreement pursuant to which we granted Ascensia the exclusive right to distribute Eversense 90 and Eversense E3 worldwide, with certain initial exceptions. Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the Eversense 90 product on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for Eversense 90 during the second quarter of 2021.
In February 2022, we received approval from the FDA for Eversense E3. The approval for our third-generation sensor, with proprietary sacrificial boronic acid (“SBA”) technology, doubles the sensor life to six months with a MARD of 8.5%. Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022.
The ENHANCE clinical study was initiated as a pivotal study with the purpose of gathering additional clinical data to support an integrated continuous glucose monitoring (“iCGM”) submission for Eversense E3 using the SBA technology. In March 2022, we extended the ongoing ENHANCE clinical study to evaluate the safety and accuracy of Eversense 365 for a period of up to one year in the United States. In September 2022, we completed enrollment of the ENHANCE study and the last patient of the adult cohort completed the study in the third quarter of 2023. In November 2022, we submitted and in the first quarter of 2023 we received approval of an investigational device exemption (“IDE”) for the enrollment of a pediatric cohort in the ENHANCE study. In 2023 the data gathered in the ENHANCE study supported the iCGM submission and in April 2024, Eversense 365 was authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future. Based on the analysis of the ENHANCE Pivotal study data, the decision was made to advance to the next generation sensor platform as the underlying technology used in the 365-day and future products. In May 2024, this data supported an FDA 510(k) submission for a new product with a 365-day duration and once per week calibration. The 510(k) submission was approved by the FDA on September 17, 2024 and Eversense 365 product was cleared for sale in the United States. Ascensia began commercializing Eversense 365 in the United States during the fourth quarter of 2024.
On September 3, 2025, the Company and Ascensia signed the MOU related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company, including the proposed termination, orderly unwinding of, and smooth transition of the commercial relationship between the Company and Ascensia. On December 31, 2025, the Company and Ascensia entered into the Master Asset Purchase Agreement, pursuant to which, among other things, the Company agreed to acquire Ascensia’s right, title and interest in and to certain assets related to the marketing, selling and distribution of Eversense in the United States (such assets, the “U.S. Purchased Assets”).
Pursuant to the terms of the Master Asset Purchase Agreement, the Company agreed to assume certain liabilities and obligations associated with the U.S. Purchased Assets (the “U.S. Assumed Liabilities” and together with the U.S. Purchased Assets, the “U.S. Asset Purchase”), including, but not limited to, certain liabilities under the contracts transferred to the Company under the Master Asset Purchase Agreement, liabilities arising out of the use or ownership of the transferred assets after the closing, and liabilities and obligations arising from certain employees who were offered employment with Senseonics Inc. pursuant to new employment letter agreements. The U.S. Asset Purchase closed on January 1, 2026 (the “U.S. Closing”).
In connection with the execution of the Master Asset Purchase Agreement, the Company and Ascensia also entered into the A&R Commercialization Agreement on December 31, 2025, which amended and restated the Existing Commercialization Agreement. The A&R Commercialization Agreement terminated Ascensia’s right to market Eversense products in the U.S. Following the U.S. Closing, Ascensia has no further rights to revenues from the sale of Eversense products in the U.S.
In an effort to accelerate commercialization efforts and address challenges to Eversense adoption, in April 2024 and July 2024, we established Eon Care Services, LLC and Eon Management Services, LLC, respectively, as wholly owned subsidiaries of Senseonics, Incorporated. In November 2024, Eon Management Services, LLC entered into management services agreements for an initial fixed term of 10 years with professional corporations created to support
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patient access to the Eversense Systems by contracting nurse practitioners and other healthcare professionals to perform Eversense insertion procedures and other clinical activities. On April 1, 2026, Eon Management Services, LLC entered into an additional management services agreement with Meadows Medical Care PC, also with an initial fixed term of 10 years. Eon Care Clinicians PC, Eon Care Clinicians of NJ PC, Eon Care Clinicians of CA PC, and Meadows Medical Care PC (collectively, the “Eon Care PCs”) are consolidated as VIEs. These management services arrangements are further described in Note 3.
The wholly owned entities and Eon Care PCs (collectively, “Eon Care”) were established to support patient access to the Eversense systems by providing convenient Eversense insertion and training services. We fully completed the transition of our network of inserters from the Nurse Practitioner Group to Eon Care in the second quarter of 2025, and we experienced an increase in the number of insertions since then. As of September 30, 2026, the Eon Care network included more than 100 inserters, who performed over 40% of U.S. Eversense insertion procedures in the nine months ended September 30, 2026. We have increased our target for the Eon Care network to 120 inserters by the end of 2026.
We have also sought to complement 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 supporting certain commercial programs such as direct to consumer (“DTC”) spending, certain key account activities, and market access support. We are determined to increase investment in supporting DTC spending, which we believe correlates with higher awareness and adoption of Eversense. Although the rate of Eversense adoption and lead generation has increased following these initiatives, as well as the regulatory approval of Eversense 365, we continue to work on ways to accelerate commercialization and adoption of our product.
In July 2024, we began first-in-human testing for the Gemini product. The next-generation Gemini product utilizes a fully implantable self-powering system that includes a flash glucose monitor with no on-body component for people with type 2 diabetes and traditional CGM with an on-body component for people with type 1 diabetes. The Gemini product is built on the 365-day sensor platform and the clinical and regulatory work will be focused on demonstrating the battery integration and functionality rather than the sensor life. Data gathered from this first-in-human testing was utilized for an IDE submission that was approved by the FDA in December 2025 which allowed us to begin enrolling patients in the Gemini study. We currently plan to complete the pivotal study during the first half of 2027, with a 510(k) submission following its completion.
In October 2026, we began first-in-human testing for the Freedom product. The Freedom product builds on the sensing technology behind our commercialized Eversense 365 system, adding an integrated battery and embedded Bluetooth Low Energy transceiver designed to communicate directly with a mobile device without an external on-body transmitter. This first-in-human study is an early feasibility evaluation of safety and device function, including direct Bluetooth communication, and follows preclinical testing of multiple antenna designs and implant locations to optimize communication performance. Data gathered from this first-in-human testing is expected to inform a planned pivotal study, which we expect to initiate in 2027.
European Commercialization of Eversense
In September 2017, we affixed the CE Mark for Eversense XL which permits the product to be sold freely in any part of the EEA. Eversense XL is indicated for a sensor life of up to 180 days. Eversense XL began commercialization in Europe in the fourth quarter of 2017. All such commercialization and marketing activities remain subject to applicable government approvals.
In June 2022, we affixed the CE Mark to Eversense E3, and Ascensia began commercialization in European markets during the second half of 2022.
In February 2025, we submitted an application for the conformity assessment of Eversense 365 to our Notified Body for certification. The submission was prepared in compliance with the EU medical device regulation. In January 2026, the Company obtained CE Mark approval for Eversense 365 and have sinced launched Eversense 365 in the European Territories on a phased basis. As of September 30, 2026, the substantial majority of our European customers had transitioned to Eversense 365, and we expect the remaining customers to transition over the coming months.
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The A&R Commercialization Agreement rendered Ascensia’s right to market Eversense products in the European Territories non-exclusive. Ascensia agreed to continue to sell and market the Eversense product in the European Territories to support the orderly transition of the business pending the closing of the European Asset Purchases and to allow Senseonics to transfer its local tender contracts. These rights and obligations apply from January 1, 2026 until the later of (i) January 1, 2027, (ii) the transfer of all local tender contracts, or (iii) the wind down of certain other commercial activities. Pursuant to the A&R Commercialization Agreement, effective January 1, 2026, the Company is entitled to 100% of the revenues derived from the sale of Eversense products in the European Territories. Senseonics will pay for certain transition services, and certain other costs, to maintain and achieve the orderly transition of the commercial operations in the European Territories. The Company and Ascensia executed separate local asset purchase agreements in the European Territories on March 12, 2026, in connection with the European Asset Purchases. The closings of the European Asset Purchases occurred in early June 2026. In Italy, Ascensia continues to provide certain transition support services to facilitate the orderly transition of commercial operations in those markets.
Financial Overview
A significant portion of our product revenue has historically been generated from sales of the Eversense system and related components and supplies to Ascensia under the Commercialization Agreement, for resale to healthcare providers and patients. Effective January 1, 2026, in connection with the transition of U.S. commercialization activities to the Company, we began generating a greater portion of our product revenue through direct sales to strategic fulfillment partners and through our consignment network in the United States. The European Asset Purchases closed in early June 2026. We assumed primary commercialization responsibilities in Spain and Sweden in June 2026 and in Germany in August 2026. During the third quarter of 2026, we also assumed primary commercialization responsibilities for substantially all activities in Italy, where Ascensia continues to provide limited transition support, including collaborating on efforts to finalize the transfer of remaining Italian tender contracts. As these operational handovers occurred, our European revenues increasingly reflected direct sales to distributors, hospital systems and other customers rather than sales to Ascensia.
Revenue from product sales to Ascensia is recognized at a point in time when Ascensia obtains control of our product based upon the delivery terms as defined in the contract at an amount that reflects the consideration which we expect to receive in exchange for the product. Following the closings of the European Asset Purchases, our contract with Ascensia is winding down. Our contract with Ascensia contains performance obligations, mostly for the supply of goods, that are typically satisfied upon transfer of control of the product. The contract does not include a right to return products unless there is a product issue, in which case we may provide replacement product. Product conformity guarantees do not create additional performance obligations and are accounted for as warranty obligations in accordance with guarantee and loss contingency accounting guidance.
The consideration we expect to receive includes estimates of variable consideration for which reserves are established, primarily arising from patient assistance program rebates, prompt-pay discounts, tier-volume price discounts and, prior to January 1, 2026, revenue share in connection with the Commercialization Agreement. Variable consideration, such as rebates and prompt-pay incentives, is treated as a reduction in revenue, and variable consideration, such as revenue share, is treated as an addition to revenue when the product sale is recognized. The amount of variable consideration that is included in the transaction price may be constrained and is included in revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgment. Depending on the variable consideration, we develop estimates for the expected value based on the terms of the agreements, historical data, geographic mix, reimbursement rates, and market conditions. Variances in the consideration recognized are partially mitigated by minimum price provisions for certain purchases under the contract.
Under the consignment model, small quantities of inventory are held at healthcare provider locations to ensure availability when a patient is identified. No revenue is recognized upon delivery of our products to the healthcare
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provider locations, as we retain the ability to control the inventory. Rather, revenue is recognized when the product is consumed by a patient.
Contract assets consist of unbilled receivables from customers and are recorded at net realizable value and relate to the timing of billings and revenue share variable consideration from the Commercialization Agreement.
Concentration of Revenue and Customers
A significant portion of the Company’s revenue has historically been derived from one customer, Ascensia. Following the Company’s transition of commercial operations from Ascensia, the Company now sells directly to our customers. For the three months ended September 30, 2026 and 2025, sales to Ascensia accounted for 1.1% and 48.0% of total revenue, respectively. For the nine months ended September 30, 2026 and 2025, sales to Ascensia accounted for 9.6% and 56.0% of total revenue, respectively. No other individual customer, including any single distributor, accounted for 10% or more of total revenue for the three or nine months ended September 30, 2026 or 2025.
A portion of the Company’s revenue is earned under consignment arrangements with healthcare providers. For the three months ended September 30, 2026 and 2025, sales under consignment arrangements accounted for 56.3% and 46.5% of total revenue, respectively. For the nine months ended September 30, 2026 and 2025, sales under consignment arrangements accounted for 56.2% and 36.0% of total revenue, respectively. During 2025, Ascensia earned commissions on sales made through these consignment arrangements for the support provided by their sales reps and commercial organization. Revenues for these corresponding periods represent sales of sensors, transmitters and miscellaneous Eversense System components.
Termination and Modification of Commercialization Arrangements
On September 3, 2025 the Company and Ascensia signed a memorandum of understanding related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company, including the proposed termination, orderly unwinding of, and smooth transition of the commercial relationship between the Company and Ascensia. On December 31, 2025, the parties entered into the Master Asset Purchase Agreement and the A&R Commercialization Agreement, pursuant to which commercial activities in the United States transitioned back to the Company effective January 1, 2026 and the commercialization rights in the European Territories were modified to be non-exclusive. In connection with the Master Asset Purchase Agreement, the Company and Ascensia executed local asset purchase agreements in the European Territories on March 12, 2026, the closings of which occurred in early June 2026. The parties continue to cooperate through the transition period and Ascensia continues to provide transition services in Italy to ensure continuity of supply, customer support, and patient access. As a result of these transition activities, our revenues and results of operations will not be directly comparable to our historical revenues and results of operations for periods in which the Commercialization Agreement was in place.
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Revenue by Geographic Region
The following table sets forth net revenue derived from our two primary geographical markets, the United States and outside of the United States, based on the geographic location to which we deliver the product, for the three and nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | |
| Three Months Ended | | | Nine Months Ended | | ||||||
| September 30, 2026 | | | September 30, 2026 | | ||||||
| | | % | | | | | % | | ||
(Dollars in thousands) | Amount | | of Total | | | Amount | | of Total | | ||
Revenue, net: | | | | | | | | | | | |
United States | $ | 16,782 | | 85.8 | % | | $ | 38,685 | | 84.5 | % |
Outside of the United States | | 2,779 | | 14.2 | | | | 7,071 | | 15.5 | |
Total | $ | 19,561 | | 100.0 | % | | $ | 45,756 | | 100.0 | % |
| | | | | | | | | | | |
| Three Months Ended | | | Nine Months Ended | | ||||||
| September 30, 2025 | | | September 30, 2025 | | ||||||
| | | % | | | | | % | | ||
(Dollars in thousands) | Amount | | of Total | | | Amount | | of Total | | ||
Revenue, net: | | | | | | | | | | | |
United States | $ | 6,421 | | 79.3 | % | | $ | 15,862 | | 75.5 | % |
Outside of the United States | | 1,674 | | 20.7 | | | | 5,139 | | 24.5 | |
Total | $ | 8,095 | | 100.0 | % | | $ | 21,001 | | 100.0 | % |
Results of Operations for the Three Months Ended September 30, 2026 and 2025
| | | | | | | | | |
| | Three Months Ended | | | | ||||
| | September 30, | | Period-to- | |||||
| | 2026 | | 2025 | | Period Change | |||
| | (in thousands) | | | | ||||
Revenue, net | | $ | 19,342 | | $ | 4,202 | | $ | 15,140 |
Revenue, net - related parties | | | 219 | | | 3,893 | | | (3,674) |
Total revenue | | | 19,561 | | | 8,095 | | | 11,466 |
Cost of sales | | | 7,492 | | | 4,627 | | | 2,865 |
Gross profit | | | 12,069 | | | 3,468 | | | 8,601 |
| | | | | | | | | |
Expenses: | | | | | | | | | |
Research and development expenses | |
| 11,667 | |
| 7,759 | |
| 3,908 |
Selling, general and administrative expenses | |
| 32,258 | |
| 15,310 | |
| 16,948 |
Operating loss | |
| (31,856) | |
| (19,601) | |
| (12,255) |
Other (expense) income, net: | | | | | | | | | |
Interest income | | | 1,173 | | | 1,236 | | | (63) |
Interest expense | |
| (1,813) | |
| (1,171) | |
| (642) |
Other (expense) income | |
| (181) | |
| 6 | |
| (187) |
Total other (expense) income, net | |
| (821) | |
| 71 | |
| (892) |
Net Loss | | $ | (32,677) | | $ | (19,530) | | $ | (13,147) |
Total revenue
Our total revenue increased to $19.6 million for the three months ended September 30, 2026, compared to $8.1 million for the three months ended September 30, 2025, an increase of $11.5 million. This increase was primarily driven
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by growth in our U.S. patient base, supported by increased marketing and patient access initiatives, a shift in sales mix toward our consignment program, which carries a higher average selling price, and increased 365-day product demand. The increase in total revenue was further driven by the elimination of Ascensia revenue share amounts following the termination of Ascensia’s commercialization rights in the United States and the transition of commercialization activities in the European Territories to a non-exclusive arrangement.
Cost of sales and gross profit
Our cost of sales increased to $7.5 million for the three months ended September 30, 2026 compared to $4.6 million for the three months ended September 30, 2025, an increase of $2.9 million. Our gross profit increased to $12.1 million for the three months ended September 30, 2026, compared to $3.5 million for the three months ended September 30, 2025. Gross profit as a percentage of revenue, or gross margin, was 61.7% and 42.8% for the three months ended September 30, 2026, and September 30, 2025, respectively. The improvement in gross margin is largely driven by favorable margins on the 365-day product sales, higher consignment network sales with price favorability, the elimination of the Ascensia revenue share, consistent fixed manufacturing costs, and the transition from Eversense E3 to Eversense 365 in Europe.
Research and development expenses
Research and development expenses were $11.7 million for the three months ended September 30, 2026 compared to $7.8 million for the three months ended September 30, 2025, an increase of $3.9 million. This increase was primarily driven by the ramp up of our Gemini clinical study which adds an implantable battery to power the sensor, as well as higher salary, contract fabrication, and consulting costs in support of additional product development projects to advance our Freedom product to eliminate the on-body transmitter component.
Selling, general and administrative expenses
Selling, general and administrative expenses were $32.2 million for the three months ended September 30, 2026, compared to $15.3 million for the three months ended September 30, 2025, representing an increase of $16.9 million. The increase consisted of a $10.7 million increase in selling and marketing personnel costs, largely driven by a large increase in headcount due to the transition of commercialization of Eversense back to the Company, an increase of $3.1 million in other sales & marketing expenses, and a $3.1 million increase in general and administrative expenses, all of which were largely driven by re-assuming commercialization activities and newly assumed operational responsibilities related to the commercial integration.
Total other (expense) income, net
Total other income (expense), net was ($0.8) million for the three months ended September 30, 2026, compared to other income (expense), net of $0.1 million for three months ended September 30, 2025, a decrease in other income (expense), net of $0.9 million. The change was primarily due to a $0.6 million increase in interest expense driven by increased borrowings under the Company’s amended debt facility with Hercules, a $0.1 million increase in unrealized losses recorded in other expense, and a $0.2 million decrease in amortization of premium and discounts.
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Results of Operations for the Nine Months Ended September 30, 2026 and 2025
| | | | | | | | | | |
| | Nine Months Ended | | | |
| ||||
| | September 30, | | Period-to- |
| |||||
| | 2026 | | 2025 | | Period Change |
| |||
| | (in thousands) | | | (in thousands) |
| ||||
Revenue, net | | $ | 41,358 | | $ | 9,235 | | $ | 32,123 | |
Revenue, net - related parties | | | 4,398 | | | 11,766 | | | (7,368) | |
Total revenue | | | 45,756 | | | 21,001 | | | 24,755 | |
Cost of sales | | | 18,188 | | | 12,907 | | | 5,281 | |
Gross profit | | | 27,568 | | | 8,094 | | | 19,474 | |
| | | | | | | | | | |
Expenses: | | | | | | | | | | |
Research and development expenses | |
| 31,917 | |
| 22,773 | |
| 9,144 | |
Selling, general and administrative expenses | |
| 95,341 | |
| 32,733 | |
| 62,608 | |
Operating loss | |
| (99,690) | |
| (47,412) | |
| (52,278) | |
Other (expense) income, net: | | | | | | | | | | |
Interest income | | | 2,947 | | | 2,884 | | | 63 | |
Interest expense | |
| (4,606) | |
| (3,745) | |
| (861) | |
Other expense | |
| (366) | |
| (17) | |
| (349) | |
Total other expense, net | |
| (2,025) | |
| (878) | |
| (1,147) | |
Net Loss | | $ | (101,715) | | $ | (48,290) | | $ | (53,425) | |
Total revenue
Our total revenue increased to $45.8 million for the nine months ended September 30, 2026 compared to $21.0 million for the nine months ended September 30, 2025, an increase of $24.8 million. This increase was primarily driven by growth in our U.S. patient base, supported by increased marketing and patient access initiatives, a shift in sales mix toward our consignment program, which carries a higher average selling price, and increased 365-day product demand. The increase in total revenue was further driven by the elimination of Ascensia revenue share amounts following the termination of Ascensia’s commercialization rights in the United States and the transition of commercialization activities in the European Territories to a non-exclusive arrangement.
Cost of sales and gross profit
Our cost of sales increased to $18.2 million for the nine months ended September 30, 2026, compared to $12.9 million for the nine months ended September 30, 2025, an increase of $5.3 million. Our gross profit increased to $27.6 million for the nine months ended September 30, 2026, compared to $8.1 million for the nine months ended September 30, 2025. Gross profit as a percentage of revenue, or gross margin, was 60.3% and 38.5% for the nine months ended September 30, 2026 and 2025, respectively. The improvement in gross margin is largely driven by favorable margins on the 365-day product sales, higher consignment network sales with price favorability, the elimination of the Ascensia revenue share, consistent fixed manufacturing costs, and the transition from Eversense E3 to Eversense 365 in Europe.
Research and development expenses
Research and development expenses were $31.9 million for the nine months ended September 30, 2026, compared to $22.8 million for the nine months ended September 30, 2025, an increase of $9.1 million. This increase was primarily driven by the ramp up of our Gemini clinical study driving efforts to enable a self-powered battery enabled sensor and additional product development projects, as well as higher salary, contract fabrication, and consulting costs in support of additional product development projects to progress our freedom product to eliminate the on-body transmitter component.
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Selling, general and administrative expenses
Selling, general and administrative expenses were $95.3 million for the nine months ended September 30, 2026, compared to $32.7 million for the nine months ended September 30, 2025, representing an increase of $62.6 million. The increase consisted of a $28.8 million increase in selling and marketing personnel costs, largely driven by a large increase in headcount due to the transition of commercialization of Eversense back to the Company, an increase of $21.5 million in other sales & marketing expenses, and a $12.3 million increase in general and administrative expenses, all of which were largely driven by re-assuming commercialization activities and newly assumed operational responsibilities related to the commercial integration.
Total other expense, net
Total other expense, net was ($2.0) million for the nine months ended September 30, 2026, compared to other expense, net of ($0.9) million for the nine months ended September 30, 2025, an increase in other expense, net of $1.1 million. The change was primarily due to a $0.9 million increase in interest expense consistent with increased borrowings under the Company’s amended debt facility with Hercules and a $0.3 million increase in other losses recorded in other expense, offset by a $0.1 million increase in other income, net.
Liquidity and Capital Resources
Sources of Liquidity
From its founding in 1996 until 2010, the Company devoted substantially all of its resources to researching various sensor technologies and platforms. Beginning in 2010, the Company narrowed its focus to developing and refining a commercially viable glucose monitoring system. The Company has incurred substantial losses and cumulative negative cash flows from operations since its inception in October 1996 and expects to incur additional losses in the near future. We incurred total net loss of $(69.1) million and $(78.6) million for the years ended December 31, 2025 and 2024, respectively. For the nine months ended September 30, 2026, the Company had a net loss of $101.7 million, and an accumulated deficit of $1.1 billion. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, warrants, convertible notes, and debt. As of September 30, 2026, the Company had unrestricted cash, cash equivalents, and marketable securities of $126.3 million.
In recent years, we have taken a number of measures to strengthen our financial position, including but not limited to the following actions:
Equity Offerings
In August 2025, we entered into an at-the-market sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”), under which we may offer and sell, from time to time, at our sole discretion, shares of common stock having an aggregate offering price of up to $100.0 million through TD Cowen as its sales agent in an “at the market” offering. TD Cowen will receive commissions up to 3.0% of the gross proceeds of any common stock sold through TD Cowen under the Sales Agreement. The shares will be offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on August 6, 2025. During the twelve months ended December 31, 2025, we received approximately $2.4 million proceeds from the sale of 334,330 shares under the Sales Agreement, after deducting sales commissions and offering expenses. During the nine months ended September 30, 2026, the Company received approximately $22.5 million in proceeds from the sale of 2,764,351 shares under the Sales Agreement, after deducting sales commissions and offering expenses. As of September 30, 2026, an aggregate of $74.1 million remained available for issuance under the Sales Agreement.
On April 30, 2026, we entered into an underwriting agreement with TD Cowen and Barclays Capital Inc., as representatives of the several underwriters named therein, for the sale of 8,000,000 shares of Common Stock and 8,000,000 pre-funded warrants, each representing the right to purchase one share of Common Stock at an exercise price
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of $0.001 per share (the “May 2026 Pre-Funded Warrants”), at a price to the public of $5.00 per share (or $4.999 per May Pre-Funded Warrant) (the “May 2026 Offering”). The May 2026 Offering closed on May 4, 2026, and the underwriters exercised in full their option to purchase 2,400,000 additional shares of Common Stock. In the aggregate, we sold 10,400,000 shares of Common Stock and 8,000,000 May 2026 Pre-Funded Warrants in the May 2026 Offering, generating aggregate gross proceeds of approximately $92.0 million, before deducting underwriting discounts and commissions and offering expenses payable by us. The net proceeds to Senseonics were approximately $86.0 million, after deducting underwriting discounts and commissions and estimated offering expenses. The securities were offered and sold pursuant to an effective shelf registration statement on Form S-3 (File No. 333-289306).
Indebtedness
Amended Loan and Security Agreement
On September 8, 2023, the Company entered into the Loan and Security Agreement with the Lenders and Hercules. The Company and Hercules have amended this agreement on two occasions, most recently on May 1, 2026 (as amended, the “Amended Loan and Security Agreement”). Under the Amended Loan and Security Agreement, the Lenders have agreed to make available to the Company the Term Loan Facility, providing for an aggregate of up to $140.0 million of loans. To date, Hercules and the Lenders have extended term loans to the Company in the aggregate amount of $55.0 million. The Amended Loan and Security Agreement provides for additional potential borrowings in the aggregate amount of up to $85 million, which may be extended in three tranches of up to $10.0 million (the “2026 Tranche 3B Loan”), up to $15.0 million (the “2026 Tranche 4 Loan”), and up to $60.0 million (the “2026 Tranche 5 Loan”), respectively, which will become available to the Company upon the Company’s satisfaction of certain terms and conditions set forth in the Amended Loan and Security Agreement and, in the case of the $60 million tranche, the Lenders’ investment committee approval. The loans under the Amended Loan and Security Agreement mature on September 3, 2029. The Company received proceeds from the Tranche 2 Loan and an additional $10.0 million tranche (the “2026 Tranche 3A Loan”) upon the closing of the Second Amendment to the Loan and Security Agreement (the “Second Amendment”) on May 6, 2026.
Convertible Notes
The 2025 Notes were repaid in full on January 15, 2025. See Note 12 in the accompanying notes to our consolidated financial statements included elsewhere in this 10-Q for further discussion of the 2025 Notes.
Funding Requirements and Outlook
Our ability to grow revenues and achieve profitability depends on the successful commercialization and adoption of our Eversense System by diabetes patients and healthcare providers, along with future product development and regulatory approvals. Successful completion of the transfer of commercial operations relating to Eversense from Ascensia back to the Company may provide opportunities to have greater influence on revenue generation and market adoption of Eversense. These activities, including our ongoing focus to grow Eversense awareness, initiatives to support patient access, and continued development of Eversense 365, will require significant uses of working capital through 2026 and beyond.
We believe that our transition to in-house commercialization of Eversense, including direct sales to distributors and through tenders, along with our growing consignment arrangements in the U.S. supported by our network of inserters, provide the operational foundation and financial resources necessary for the manufacturing and distribution of Eversense and continued product development. We expect that existing cash, cash equivalents and cash flows from our future operations will be sufficient to meet the Company’s current operating plans into 2028. As part of our liquidity strategy, we will continue to monitor our capital structure and market conditions going forward and we may access the debt and equity or equity linked markets for additional funding if the opportunity arises to enhance our capital structure, for changes to our operating plans, for financing strategic initiatives and to provide financial flexibility.
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Cash Flows
The following is a summary of cash flows for each of the periods set forth below (in thousands).
| | | | | | | |
|
| Nine Months Ended | | ||||
|
| September 30, | | ||||
|
| 2026 | | 2025 | | ||
Net cash used in operating activities | | $ | (95,099) | | $ | (41,164) |
|
Net cash used in investing activities | |
| (25,866) | |
| (76,065) | |
Net cash provided by financing activities | |
| 128,490 | |
| 77,090 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | | $ | 7,525 | | $ | (40,139) | |
Net cash used in operating activities
Net cash used in operating activities was $95.1 million for the nine months ended September 30, 2026, and consisted of a net loss of $101.7 million and a net cash outflow from changes in operating assets and liabilities of $6.4 million, partially offset by non-cash changes of $13.0 million, consisting of $9.4 million of stock-based compensation, $1.8 million of allowance for credit losses, $1.6 million related to depreciation/amortization, and $0.2 million of other non-cash items, net.
Net cash used in operating activities was $41.2 million for the nine months ended September 30, 2025, and consisted of a net loss of $48.3 million and a net change in operating assets and liabilities of $2.5 million partially offset by $7.5 million of stock-based compensation and $2.1 million related to depreciation/amortization and other non-cash items, net.
Net cash used in investing activities
Net cash used in investing activities was $25.9 million for the nine months ended September 30, 2026, and consisted of $101.1 million in purchases of marketable securities, $0.6 million in capital expenditures, and $1.3 million for cash paid in connection with the asset acquisition, partially offset by $77.1 million in proceeds from the sale and maturity of marketable securities.
Net cash used in investing activities was $76.1 million for the nine months ended September 30, 2025, and consisted of $100.7 million in purchases of marketable securities and $0.7 million of capital expenditures, offset by $25.4 million in proceeds from the sale and maturity of marketable securities.
Net cash provided by financing activities
Net cash provided by financing activities was $128.5 million for the nine months ended September 30, 2026, and primarily consisted of $109.8 million in proceeds from the issuance of common stock and prefunded warrant proceeds, $0.2 million in proceeds from the exercise of stock options, RSUs, and ESPP issuances, and $19.8 million in proceeds from borrowings under the Loan and Security Agreement, partially offset by $1.3 million in taxes paid related to net share settlement of equity awards.
Net cash provided by financing activities was $77.1 million for the nine months ended September 30, 2025, and primarily consisted of $72.3 million in net proceeds from the Public Offering and Private Placement, $26.7 million in net proceeds from issuances of common stock under the Equity Distribution Agreement, offset by $20.4 million used to repay the remaining outstanding 2025 Notes, $1.2 million from taxes paid related to net share settlement of equity awards and $0.4 million used to repay the debt modification costs.
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ITEM 3: Quantitative and Qualitative Disclosures About Market Risk
Under SEC rules and regulations, because we are considered to be a “smaller reporting company,” we are not required to provide the information required by this item in this Quarterly Report on Form 10-Q.
ITEM 4: Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the assistance of our chief executive officer, who is our principal executive officer, and our chief financial officer, who is our principal financial officer, has reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of September 30, 2026. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed by us in the periodic reports filed with the SEC is accumulated and communicated to our management, including our principal executive, financial and accounting officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving such control objectives. Based on the evaluation of our disclosure controls and procedures as of September 30, 2026, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II: OTHER INFORMATION
ITEM 1: 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.
For the period ended September 30, 2026, there were no material legal proceedings brought against us nor were there any material developments to any ongoing legal proceedings which constituted reportable events.
ITEM 1A: Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Except as set forth below, there have been no material changes from our risk factors described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 2, 2026.
Risks Related to our Financial Results and Need for Financing
Future borrowings under the Second Amendment to our Amended Loan and Security Agreement with Hercules Capital, Inc. are subject to conditions that may not be satisfied, and we may not have access to the full amount of the facility.
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On May 1, 2026, we entered into the Second Amendment to our Amended Loan and Security Agreement with Hercules (the “Second Amendment”), which increased the total potential borrowings under the agreement from $100.0 million to $140.0 million. As of the date of this report, we have drawn an aggregate of $55 million of borrowings under the Hercules facility. However, future borrowings under the agreement are subject to the satisfaction of certain terms and conditions and, with respect to the final $60.0 million, the approval of Hercules’s investment committee. There can be no assurance that such conditions to funding will be satisfied. If we are unable to access the full amount of the facility, we may not have sufficient liquidity to fund our operations and may need to seek additional financing on terms that may be less favorable, or we may not be able to obtain additional financing at all.
Our increased indebtedness under the amended Hercules facility may adversely affect our financial condition, and we may not be able to maintain compliance with the financial covenants contained therein.
As a result of the Second Amendment, we have the potential to incur significantly greater indebtedness under the amended Hercules facility. Increased indebtedness could, among other things, increase our vulnerability to general adverse economic and industry conditions, limit our flexibility in planning for or reacting to changes in our business and the industry in which we operate, and place us at a competitive disadvantage compared to our competitors that have less debt. In addition, we will be required to comply with financial and other covenants in the amended facility and our ability to comply with these covenants will depend on our future operating performance, which is subject to prevailing economic conditions and other factors, many of which are beyond our control. If we fail to comply with these covenants, we could be in default under the facility, which could result in the acceleration of all outstanding indebtedness thereunder and materially adversely affect our financial condition and ability to continue as a going concern.
ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
ITEM 3: Defaults Upon Senior Securities
Not applicable.
ITEM 4: Mine Safety Disclosures
Not applicable.
ITEM 5: Other Information
During the fiscal quarter ended September 30, 2026, none of our officers or directors, as defined in Rule 16a-1(f),
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ITEM 6: Exhibits
The exhibits listed on the Exhibit Index hereto are filed or incorporated by reference (as stated therein) as part of this Quarterly Report on Form 10-Q.
| ||
Exhibit No. | | Document |
| | |
3.1 | | Amended and Restated Certificate of Incorporation of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on March 23, 2016). |
| | |
3.2 | | Amended and Restated Bylaws of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on March 23, 2016). |
| | |
3.3 | | Certificate of Amendment to Amended and Restated Certificate of Incorporation of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.3 to the Registrant’s Quarterly Report on Form 10-Q for the Quarter ended June 30, 2018 (File No. 001-37717), filed with the Commission on August 8, 2018). |
| | |
3.4 | | Certificate of Amendment to Amended and Restated Certificate of Incorporation of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on May 22, 2024). |
| | |
3.5 | | Certificate of Amendment to Amended and Restated Certificate of Incorporation of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on October 16, 2025). |
| | |
3.6 | | Certificate of Amendment to Amended and Restated Certificate of Incorporation of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on May 20, 2026). |
| | |
3.7 | | Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on August 18, 2020). |
| | |
3.8 | | Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717) filed on October 26, 2020). |
| | |
3.9 | | Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.5 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37717) filed with the Commission on November 8, 2022). |
| | |
3.10 | | Amendment to Bylaws of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.7 to the Registrant’s Annual Report on Form 10-K (File No. 001-37717) filed with the Commission on March 5, 2021). |
| | |
31.1* | | Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act. |
| | |
31.2* | | Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act. |
| | |
32.1** | | Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act. |
| | |
101.INS* | | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document) |
| | |
101.SCH* | | Inline XBRL Taxonomy Extension Schema Document |
| | |
101.CAL* | | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| | |
101.DEF* | | Inline XBRL Taxonomy Extension Definition Linkbase Document |
| | |
101.LAB* | | Inline XBRL Taxonomy Extension Label Linkbase Document |
| | |
101.PRE* | | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| | |
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104 | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* | Filed herewith. |
** | These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | |
| SENSEONICS HOLDINGS, INC. | |
| | |
| | |
Date: November 9, 2026 | By: | /s/ Rick Sullivan |
| | Rick Sullivan |
| | Chief Financial Officer |
| | (Principal Financial Officer) |
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