[10-Q] Senseonics Holdings, Inc. Quarterly Earnings Report
Senseonics Holdings, Inc. filed its Q3 2025 10‑Q, reporting total revenue of $8.1 million, up from $4.3 million a year ago, and a net loss of $19.5 million. Gross profit was $3.5 million versus a gross loss in the prior year period.
The company ended the quarter with $111.0 million in unrestricted cash, cash equivalents and marketable securities. Management disclosed that substantial doubt exists regarding its ability to continue as a going concern, citing expected cash needs and covenant requirements under its amended loan agreement.
Senseonics amended its term loan facility on September 3, 2025, increasing capacity to $100.0 million (maturing September 3, 2029) with a minimum cash covenant. It also raised capital via a $57.5 million public offering and a concurrent $20.3 million private placement with Abbott in May, and established a $100.0 million at‑the‑market program in August. A 1‑for‑20 reverse stock split became effective on October 17, 2025. The company signed an MOU with Ascensia to transition Eversense commercialization back to Senseonics beginning January 1, 2026.
- None.
- Going concern uncertainty disclosed due to expected cash needs and covenant requirements.
Insights
Going concern disclosed despite larger cash balance.
Senseonics reported a quarter-end liquidity pool of
The loan bears at least
Key near-term items include adherence to the minimum cash thresholds and any draws on remaining loan tranches. Equity capacity exists via the
Revenue improved; commercialization transition sets 2026 pivot.
Total revenue reached
An MOU with Ascensia contemplates terminating the Commercialization Agreement and moving commercial activities in-house beginning
Capital actions included a public offering of
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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)
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| 3841 |
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(
(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
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TABLE OF CONTENTS
PART I: Financial Information |
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ITEM 1: Financial Statements | | |
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Condensed Consolidated Balance Sheets as of September 30, 2025 (Unaudited) and December 31, 2024 | | 3 |
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2025 and 2024 | | 4 |
Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2025 and 2024 | | 5 |
Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 | | 6 |
Notes to Unaudited Condensed Consolidated Financial Statements | | 7 |
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ITEM 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 27 |
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ITEM 3: Quantitative and Qualitative Disclosures About Market Risk | | 38 |
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ITEM 4: Controls and Procedures | | 39 |
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PART II: Other Information | | 39 |
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ITEM 1: Legal Proceedings | | 39 |
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ITEM 1A: Risk Factors | | 40 |
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ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds | | 46 |
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ITEM 3: Defaults Upon Senior Securities | | 46 |
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ITEM 4: Mine Safety Disclosures | | 46 |
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ITEM 5: Other Information | | 47 |
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ITEM 6: Exhibits | | 47 |
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SIGNATURES | | 48 |
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Senseonics Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
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| | September 30, | | December 31, | ||
| | 2025 | | 2024 | ||
| | | (unaudited) | | | |
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Assets | | |
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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 | |
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Total current assets | |
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Deposits and other assets | |
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Property, equipment and intangible assets, net | |
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Total assets | | $ | | | $ | |
Liabilities and Stockholders’ Equity (Deficit) | | | | | | |
Current liabilities: | | | | | | |
Accounts payable | | $ | | | $ | |
Accrued expenses and other current liabilities | |
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Accrued expenses and other current liabilities, related parties | | | | | | |
Notes payable, current portion, net | | | — | | | |
Total current liabilities | |
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Long-term debt and notes payables, net | | | | | | |
Non-current operating lease liabilities | | | | | | |
Total liabilities | |
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Preferred stock and additional paid-in-capital, subject to possible redemption: $ | | | — | | | |
Total temporary equity | | | — | | | |
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Commitments and contingencies | | | | | | |
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Stockholders’ equity (deficit): | | | | | | |
Common stock, $ | |
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Additional paid-in capital | |
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Accumulated other comprehensive income | | | | | | — |
Accumulated deficit | |
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Total stockholders’ equity (deficit) | |
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Total liabilities, temporary equity and stockholders’ equity (deficit) | | $ | | | $ | |
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)
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| | Three Months Ended | | Nine Months Ended | ||||||||
| | September 30, | | September 30, | ||||||||
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| 2025 |
| 2024 |
| 2025 |
| 2024 | ||||
Revenue, net | | $ | |
| $ | | | $ | | | $ | |
Revenue, net - related parties | | | | | | | | | | | | |
Total revenue | | | | | | | | | | | | |
Cost of sales | | | | | | | | | | | | |
Gross profit (loss) | | | | | | ( | | | | | | ( |
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Expenses: | | | | | | | | | | | | |
Research and development expenses | | | | |
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Selling, general and administrative expenses | | | | |
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Operating loss | | | ( | |
| ( | | | ( | |
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Other income (expense), net: | | | | | | | | | | | | |
Interest income | | | | | | | | | | | | |
Interest expense | | | ( | | | ( | | | ( | | | ( |
Gain on change in fair value of derivatives | | | — | | | — | | | — | | | |
Other income (expense) | | | | | | ( | | | ( | | | |
Total other income (expense), net | | | | | | ( | | | ( | | | ( |
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Net Loss | | | ( | | | ( | | | ( | | | ( |
Other comprehensive income | | | | | | | | | | | | |
Unrealized gain on marketable securities | | | | | | | | | | | | |
Other comprehensive gain | | | | | | | | | | | | |
Total comprehensive loss | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
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Basic net loss per common share | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
Basic weighted-average shares outstanding | | | | | | | | | | | | |
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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 (Deficit)
(in thousands)
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | Accumulated | | | | | | | | | Series B | |
| | Common Stock | | Paid-In | | Other | | Accumulated | | Stockholders' | | Convertible | ||||||||
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| Shares |
| Amount |
| Capital |
| Comprehensive Income (Loss) | | Deficit | | Equity (Deficit) |
| Preferred Stock Temporary Equity | ||||||
Three months ended September 30, 2024: | | | | | | | | | | | | | | | | | | | | |
Balance, June 30, 2024 | | | | $ | | | $ | | | $ | ( | | | ( | | $ | | | $ | |
Issuance of common stock, net of issuance costs | | | | | — | | | | | | — | | | — | | | | | | — |
Issued common stock for vested RSUs and ESPP purchase | | | | | — | | | | | | — | | | — | | | | | | — |
Issuance of warrants, net of issuance costs | | — | | | — | | | | | | — | | | — | | | | | | — |
Stock-based compensation expense | | — | | | — | | | | | | — | | | — | | | | | | — |
Net loss | | — | | | — | | | — | | | — | | | ( | | | ( | | | — |
Other comprehensive income, net of tax | | — | | | — | | | — | | | | | | — | | | | | | — |
Balance, September 30, 2024 | | | | $ | | | $ | | | $ | | | $ | ( | | $ | ( | | $ | |
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Nine months ended September 30, 2024: | | | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2023 |
| | | $ | | | $ | | | $ | ( | | $ | ( | | $ | | | $ | |
Issuance of common stock, net of issuance costs | | | | | — | | | | | | — | | | — | | | | | | — |
Issued common stock for vested RSUs and ESPP purchase | | | | | — | | | | | | — | | | — | | | | | | — |
Issuance of warrants, net of issuance costs | | — | | | — | | | | | | — | | | — | | | | | | — |
Exercise of stock options and warrants | | — | | | — | | | | | | — | | | — | | | | | | — |
Stock-based compensation expense |
| — | | | — | | | | | | — | | | — | | | | | | — |
Shares withheld related to net share settlement of equity awards | | ( | | | — | | | ( | | | — | | | — | | | ( | | | — |
Net loss | | — | | | — | | | — | | | — | | | ( | | | ( | | | — |
Other comprehensive income, net of tax |
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Balance, September 30, 2024 |
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| $ | | | $ | ( | | $ | ( | | $ | |
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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 purchase | | | | | — | | | | | | — | | | — | | | | | | — |
Issuance of warrants, net of issuance costs | | — | | | — | | | ( | | | — | | | — | | | ( | | | — |
Stock-based compensation expense | | — | | | — | | | | | | — | | | — | | | | | | — |
Net loss | | — | | | — | | | — | | | — | | | ( | | | ( | | | — |
Other comprehensive gain | | — | | | — | | | — | | | | | | — | | | | | | — |
Balance, September 30, 2025 | | | | $ | | | $ | | | $ | | | $ | ( | | $ | | | $ | — |
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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 purchase | | | | | — | | | | | | — | | | — | | | | | | — |
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 gain | | — | | | — | | | — | | | | | | — | | | | | | — |
Balance, September 30, 2025 |
| | | $ | | | $ | |
| $ | | | $ | ( | | $ | | | $ | — |
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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)
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| Nine Months Ended | ||||
| September 30, | ||||
| 2025 | | 2024 | ||
Cash flows from operating activities | | |
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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 | | ( | | | ( |
Gain on change in fair value of derivatives | | — | | | ( |
Stock-based compensation expense |
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Provision for inventory obsolescence and 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 | | | | | |
Accrued interest | | ( | | | ( |
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 | | | | | |
Net cash used in investing activities |
| ( | |
| ( |
Cash flows from financing activities | | | | | |
Proceeds from at-the-market sales of common stock, net | | | | | |
Proceeds from issuance of common stock in Public Offering, net | | | | | — |
Proceeds from issuance of common stock in Private Placement, net | | | | | — |
Proceeds from exercise of stock options, RSUs and ESPP issuances, net | | | | | |
Proceeds from issuance of term loan, net | | — | | | |
Taxes paid related to net share settlement of equity awards |
| ( | | | ( |
Repayment of 2025 Notes | | ( | | | — |
Payment of debt modification costs | | ( | | | — |
Net cash provided by financing activities |
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Net decrease in cash, cash equivalents, and restricted cash |
| ( | |
| ( |
Cash, cash equivalents, and restricted cash at beginning of period |
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Cash, cash equivalents, and restricted cash at ending of period | $ | | | $ | |
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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 | | | | | |
Issuance of common stock upon conversion of preferred shares | | | | | — |
Issuance of warrants for Loan and Security Agreement | | — | | | |
Change in exercise price of warrants due to Amended Loan and Security Agreement | | ( | | | — |
Reverse stock split - reclassification from common stock to additional paid-in capital | | | | | |
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. 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
2. | Liquidity, Capital Resources and Going Concern |
From its founding in 1996 until 2010, the Company has 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. Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future. We incurred total net loss of $
The Company’s ability to grow revenues and achieve profitability depends on the successful commercialization and adoption of our implantable CGM, including the Eversense E3 system (“Eversense E3”) and the Eversense 365 system (“Eversense 365” and, together with Eversense E3, “Eversense” or the “Eversense Systems”), by diabetes patients and healthcare providers, along with future product development, regulatory approvals, and post-approval requirements. These activities including the costs associated with our plans to transition the commercial activities back to
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the Company (as further described in FN 4) and continued development of the Gemini product, Freedom product and other future products, will require significant uses of working capital through 2025 and beyond.
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Based on the Company’s current operating plan including expected capital investments required to assume commercialization and distribution responsibilities, existing unrestricted cash and cash equivalents, minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under its Amended Loan and Security Agreement as discussed in Note 12, the Company has determined that substantial doubt exists regarding its ability to continue as a going concern. The Company will require additional liquidity to continue its operations over the next twelve months and we are currently evaluating strategies to obtain the required additional funding for future operations. We anticipate that our principal uses of cash in the future will be primarily to fund our operations, working capital needs, capital expenditures and other strategic initiatives. Our ability to continue to fund our operations and meet capital needs will depend on our ability to successfully obtain funding from public or private debt and equity financings and other sources of capital. There can be no assurance that additional capital will be available on acceptable terms, or at all. See further described below under “Funding Requirements and Outlook” for additional information.
The consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.
Several actions have been taken by the Company with regards to liquidity and to manage our cash flows during the years ended December 31, 2023 and 2024 and nine months ended September 30, 2025. These actions included, but were not limited to the following:
On September 8, 2023 (the “Effective Date”), the Company entered into a loan agreement (the “Loan and Security Agreement”) with the several institutions or entities party thereto (collectively, the “Lenders”) and Hercules Capital, Inc., a Maryland corporation (“Hercules”) in its capacity as administrative agent and collateral agent for itself and the Lenders, pursuant to which the Lenders agreed to make available to the Company up to $
In August 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 $
On May 15, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with several underwriters for the sale of
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price of $
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 $
On November 9, 2020, we entered into an Equity Line Agreement with Energy Capital (the “Equity Line Agreement”), pursuant to which Energy Capital committed to purchase up to an aggregate of $
3. | Summary of Significant Accounting Policies |
Basis of Presentation
The accompanying unaudited 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 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 have 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, 2025, and December 31, 2024, results of operations, comprehensive loss, and changes in stockholders’ equity (deficit) for the three and nine months ended September 30, 2025 and 2024 and cash flows for the nine months ended September 30, 2025 and 2024 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, 2024, as filed with the SEC on March 3, 2025. The interim results for September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025, or for any future interim periods.
The unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal
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course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. As discussed in Note 2, based on the Company’s current operating plan including capital considerations required to assume commercialization and distribution responsibilities, existing unrestricted cash, cash equivalents and marketable securities and minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under its Amended Loan and Security Agreement as discussed in Note 12, the Company has determined that substantial doubt exists regarding its ability to continue as a going concern. The Company will require additional liquidity to continue its operations over the next 12 months and we are currently evaluating strategies to obtain the required additional funding for future operations.
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 have been determined to be VIEs of the Company, as the Company is its 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 have 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. Our variable interest entities’ 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, 2024.
Recent Accounting Pronouncements
In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), the objective of which is to enhance the transparency of income tax disclosures by requiring greater disaggregation of information presented and consistent categories in the rate reconciliation. ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024. We expect the adoption of this guidance will modify our disclosures, but we do not expect it to have an impact on our consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, “Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses” to improve disclosures by providing more detailed information about the types of expenses in commonly presented expense captions. The guidance is effective for annual reporting periods beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effect this standard will have on its consolidated financial statements and related disclosures.
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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 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, derivative assets and liabilities, 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.
4. Revenue Recognition
The Company generates product revenue from sales of the Eversense Systems and related components and supplies to Ascensia Diabetes Care Holdings AG (“Ascensia”), through a collaboration and commercialization agreement (the “Commercialization Agreement”), third-party distributors outside the United States and to strategic fulfillment partners in the United States, who then resell the products to health care providers and patients, or directly to health care systems and health care providers (collectively, the “Customers”). Customers pay the Company for sales, regardless of whether or not the Customers resell the products to health care providers and patients. The Company also generates product revenue from sales of the Eversense Systems and related components and supplies through a consignment model with our network of healthcare professionals 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 our Annual Report on Form 10-K for the year ended December 31, 2024.
Revenue by Geographic Region
The following table sets forth net revenue derived from the Company’s
| | | | | | | | | | | |
| 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 | $ | | | % | | $ | | | % | ||
| | | | | | | | | | | |
| Three Months Ended | | Nine Months Ended | | |||||||
| September 30, 2024 | | | September 30, 2024 | | ||||||
| | | % | | | | | % | | ||
(Dollars in thousands) | Amount | | of Total | | | Amount | | of Total | | ||
Revenue, net: | | | | | | | | | | | |
United States | $ | | | % | | $ | | | % | ||
Outside of the United States | | | | | | | | | | ||
Total | $ | | | % | | $ | | | % | ||
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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, 2025 and December 31, 2024 are unbilled accounts receivable of $
Concentration of Revenue and Customers
A significant portion of the Company’s revenue is derived from one customer, Ascensia. For the three months ended September 30, 2025 and 2024, 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, 2025 and 2024, sales under consignment arrangements accounted for
Termination of the Commercialization Agreement
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, including the proposed termination, orderly unwinding of, and smooth transition of the commercial relationship between the Company and Ascensia (the “Proposed Transition”), which is contemplated to involve the termination of the existing Commercialization Agreement, with commercial activities expected to transition back to the Company beginning January 1, 2026 pursuant to a definitive agreement which the parties are negotiating. The parties are collaborating on developing terms to cooperate through the transition period to ensure continuity of supply, customer support, and patient access. As of the termination date of the Commercialization Agreement, the Company will no longer recognize revenue associated with product sales to Ascensia under the distribution arrangement. Any remaining deferred revenue, contract assets, or liabilities associated with this agreement will be evaluated and recognized in accordance with ASC 606 based on the satisfaction (or non-satisfaction) of performance obligations as of the termination date.
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
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.
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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, | |||||
| | 2025 | | 2024 | | 2025 | | 2024 |
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, | ||||
|
| 2025 |
| 2024 | | 2025 | | 2024 |
Stock-based awards | | | | | | | | |
2025 Notes | | — | | | | — | | |
Series B Preferred Stock | | — | | | | — | | |
Warrants | | | | | | | | |
Total anti-dilutive shares outstanding | | | | | | | | |
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, | |||
|
| 2025 |
| 2024 | |||
| Cash | | $ | | | $ | |
| Money market funds | | | | | | |
| Restricted Cash | | | | | | |
| Total cash, cash equivalents, and restricted cash | | $ | | | $ | |
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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, | ||
|
| 2025 |
| 2024 | ||
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, | ||
| | 2025 |
| 2024 | ||
Finished goods |
| $ | |
| $ | |
Work-in-process | |
| | |
| |
Raw materials | |
| | |
| |
Total | | $ | | | $ | |
The Company charged $
The Company capitalizes inventory costs associated with products when future commercialization is considered probable and the future economic benefit is expected to be realized, which is typically when regulatory approval is obtained. As such, the Company began capitalizing costs related to the 365-day product inventory in September 2024 upon successfully obtaining FDA 510(k) clearance. Prior to regulatory approval, the Company expensed all inventory-related costs, including that used for clinical development, to research and development expenses and this has resulted in lower cost of sales as the pre-clearance inventory is sold to customers. The total product costs expensed to research and development expenses prior to the clearance were $
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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, | ||
| | 2025 |
| 2024 | ||
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, 2025 | ||||||||||
| | | | Gross | | Gross | | Estimated | ||||
| | Amortized | | Unrealized | | Unrealized | | Market | ||||
|
| Cost |
| Gains |
| Losses |
| Value | ||||
Commercial Paper | | $ | | | $ | | | $ | ( | | $ | |
Corporate debt securities | | | | | | | | | — | | | |
Government and agency securities | | | | | | | | | — | | | |
Total | | $ | | | $ | | | $ | ( | | $ | |
There were
The following are the scheduled maturities as of September 30, 2025 (in thousands):
| | | | | | |
| | Net | | Fair | ||
| | Carrying Amount | | Value | ||
2025 (remaining three months) |
| $ | | | $ | |
2026 | |
| | |
| |
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, 2025 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 the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
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8. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
| | 2025 |
| 2024 | ||
Tax credits receivable(1) | | $ | | | $ | |
Sales and marketing | | | | | | |
Contract manufacturing (2) | | | | | | |
Clinical and Preclinical | |
| | |
| |
Interest receivable | | | | | | — |
Insurance | | | | | | |
IT and software | | | | | | |
Rent and utilities | | | | | | |
Accounting and audit | | | — | | | |
Other | | | | | | |
Total prepaid expenses and other current assets | | $ | | | $ | |
| (1) | Refundable employee retention credits, enacted under the CARES Act. |
| (2) | Includes deposits to contract manufacturers for manufacturing process. |
9. | Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consisted of the following (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
| | 2025 |
| 2024 | ||
Compensation and benefits | | $ | | | $ | |
Sales and marketing services |
| | |
| | |
Professional and administrative services | | | | | | |
Research and development | |
| | |
| |
Contract manufacturing | |
| | |
| |
Operating lease | | | | | | |
Product warranty and replacement obligations | | | | | | |
Interest on notes payable | | | | | | |
Accrued construction and renovation costs | | | | | | |
Other | | | | | | |
Total accrued expenses and other current liabilities | | $ | | | $ | |
10. | Leases |
The Company leases approximately
Operating lease expense was $
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The following table summarizes the lease assets and liabilities as of September 30, 2025 and December 31, 2024 (in thousands):
| | | | | | | | |
| | | | | | September 30, | | December 31, |
Operating Lease Assets and Liabilities | | Balance Sheet Classification | | 2025 | 2024 | |||
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 | | | | | $ | | $ | |
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, 2025 (in thousands):
| | | |
2025 (remaining 3 months) |
| $ | |
2026 | | | |
2027 | | | |
2028 | | | |
2029 | | | |
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, 2025:
| | | |
Remaining lease term (years) | | 2025 | |
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, 2025, and for the twelve months ended December 31, 2024 (in thousands):
| | | | | | |
| | September 30, | | December 31, | ||
|
| 2025 |
| 2024 | ||
Balance at beginning of the period | | $ | | | $ | |
Provision for warranties during the period | | | | | | |
Settlements made during the period | | | ( | | | ( |
Balance at end of the period | | $ | | | $ | |
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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 $
The loans under the Amended Loan and Security Agreement 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
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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, 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 Loan and Security Agreement, the Company incurred $
Pursuant to the Amended Loan and Security Agreement, the Company also agreed to issue additional
Registered Direct Offering
On October 24, 2024, the Company completed a registered direct securities offering (the “2024 Registered Direct Offering”) to certain institutional investors in which we issued and sold
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and the Company received proceeds of approximately $
Convertible Notes
2025 Notes
In July 2019, the Company issued $
The 2025 Notes also contained an embedded conversion option requiring bifurcation as a separate derivative liability, along with the fundamental change make-whole provision and the cash settled fundamental make-whole shares provision. The derivative is adjusted to fair value at each reporting period, with the change in the fair value recorded to other income (expense) in the Company’s consolidated statement of operations and comprehensive loss.
On April 21, 2020, $
On August 10, 2023, the Company entered into separate, privately negotiated exchange agreements (the “Exchange Agreements”) with a limited number of holders (the “Noteholders”) of the Company’s currently outstanding 2025 Notes. Under the terms of the Exchange Agreements, the Noteholders agreed to exchange with the Company (the “Exchanges”) up to $
Following the Exchanges, approximately $
Stock Purchase Warrants
The table below summarizes the warrant activity for the nine months ended September 30, 2025 (in thousands). This table does not include the PHC Exchange Warrant or the PHC Purchase Warrant (described below). Such warrants are pre-funded and excluded from the table due to their nominal exercise price of $
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| | | | | | | | |
| | Shares | | | Exercise price (per share) | | | Weighted average exercise price (per share) |
Outstanding, December 31, 2024 |
|
| $ |
| $ | | ||
Granted |
| — |
| | — |
| | — |
Exercised |
| — |
| | — |
| | — |
Expired |
| — |
| | — |
| | — |
Outstanding and Exercisable, September 30, 2025 |
|
| $ |
| $ | | ||
|
| |
| | | | | |
Weighted Average Remaining Life, September 30, 2025 (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
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
On January 2, 2024, we issued the Tranche 2 Warrants to acquire an aggregate of
On October 24, 2024, in connection with the 2024 Registered Direct Offering, the Company issued to the investors in the offering the PP Warrants to purchase an aggregate of
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The following carrying amounts were outstanding under the Company’s notes payable as of September 30, 2025 and December 31, 2024 (in thousands):
| | | | | | | |
| September 30, 2025 | ||||||
| Principal ($) | | Debt (Discount) Premium ($)⁽¹⁾ | | Issuance Costs ($) | | Carrying Amount ($) |
Amended Loan and Security Agreement | | | | | ( | | |
| | | | | | | |
| December 31, 2024 | ||||||
| Principal ($) | | Debt (Discount) Premium ($)⁽¹⁾ | | Issuance Costs ($) | | Carrying Amount ($) |
2025 Notes | | | ( | | ( | | |
Loan and Security Agreement | | | ( | | ( | | |
| (1) | Includes accretion of end of term fees payable at maturity. |
Interest expense related to the notes payable for the nine months ended September 30, 2025 and 2024 was as follows (dollars in thousands):
| | | | | | | | | |
| 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 | | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Nine Months Ended September 30, 2024 | ||||||||
| Interest Rate | | Interest ($) | | Debt Discount and Fees ($)⁽¹⁾ | | Issuance Costs ($) | | Total Interest Expense ($) |
2025 Notes | | | | | | | | | |
Loan and Security Agreement | | | | | | | | | |
Total | | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| (1) | Includes accretion of end of term fees payable at maturity. |
The following are the scheduled maturities of the Company’s notes payable (including end of term fees) as of September 30, 2025 (in thousands):
| | | |
2027 | | $ | |
2028 | | | |
2029 | | | |
Total |
| $ | |
13. | Stockholders’ Equity |
On August 6, 2025, the Company entered into the Sales Agreement with 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 $
On May 15, 2025, the Company entered into the Underwriting Agreement related to the Public Offering with several underwriters for the sale of
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the Underwriting Agreement, the Company also granted the underwriters a 30-day option to purchase up to an additional
On October 24, 2024, the Company completed a registered direct securities offering (the “2024 Registered Direct Offering”) to certain institutional investors in which we issued and sold
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 $
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
Inducement Plan
On May 30, 2019, the Company adopted the Senseonics Holdings, Inc. Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved
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inducement grants in accordance with NYSE American Company Guide Section 711(a), including individuals who were not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to such persons entering into employment with the Company. An “Award” is any right to receive the Company’s common stock pursuant to the Inducement Plan, consisting of non-statutory options, restricted stock unit awards and other equity incentive awards. As of September 30, 2025,
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
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
1997 Plan
On May 8, 1997, the Company adopted the 1997 Stock Option Plan (the “1997 Plan”), under which incentive stock options, non-qualified stock options, and restricted stock awards may be granted to the Company’s employees and certain other persons in accordance with the 1997 Plan provisions. Approximately
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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, 2025 and December 31, 2024 (in thousands):
| | | | | | | | | | | | | |
| | September 30, 2025 |
| ||||||||||
Asset Class |
| Total |
| Level 1 |
| Level 2 |
| Level 3 |
| ||||
Cash and Cash Equivalents | | | | | | | | | | | | | |
Money market funds | | $ | | | | | | | — | | | — | |
Short Term Investments | | | | | | | | | | | | | |
Commercial paper (>3 months) | | $ | | | | — | | | | | | — | |
Corporate debt securities | | | | | | — | | | | | | — | |
Government and agency securities (>3 months) | | | | | | | | | — | | | — | |
| | | | | | | | | | | | | |
| | December 31, 2024 |
| ||||||||||
Asset Class |
| Total |
| Level 1 |
| Level 2 |
| Level 3 |
| ||||
Cash and Cash Equivalents | | | | | | | | | | | | | |
Money market funds | | $ | | | | | | | — | | | — | |
| | | | | | | | | | | | | |
16. | Income Taxes |
The Company has
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, extending key provisions of the 2017 Tax Cuts and Jobs Act including, but not limited to, bonus depreciation and deductions for domestic research and development expenditures. The Company is currently evaluating OBBBA; however, it is not expected to have a material impact on the Company’s consolidated financial statements.
17. Related Party Transactions
PHC has a noncontrolling ownership interest in the Company. In addition, PHC has representation on the Company’s Board of Directors. The Company entered into a financing agreement with PHC on August 9, 2020 and entered into an exchange agreement with PHC during 2023. Ascensia, through the ownership interests of its parent company, PHC, is a related party.
Revenue from Ascensia during the nine months ended September 30, 2025 and 2024 was $
The amount due from Ascensia as of September 30, 2025 and December 31, 2024 was $
As previously discussed in Note 4, on September 3, 2025 the Company and Ascensia signed a MOU related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company, including the Proposed Transition, which is contemplated to involve the termination of the existing Commercialization Agreement, with
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commercial activities expected to transition back to the Company beginning January 1, 2026 pursuant to definitive agreements to be negotiated during the fourth quarter governing the Proposed Transition. The parties will cooperate through the transition period to ensure continuity of supply, customer support, and patient access.
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 on how to invest into 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, 2025 and 2024:
| | | | | | | | | | | |
| Three Months Ended | | Nine Months Ended | ||||||||
| September 30, | | September 30, | ||||||||
| | 2025 | | | 2024 | | | 2025 | | | 2024 |
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, 2025, and events which occurred subsequently but were not recognized in the financial statements. Except as described below there were no other subsequent events which required recognition, adjustment to or disclosure in the financial statements.
On October 3, 2025, the Company’s Board of Directors approved the one-for-twenty Reverse Stock Split. The Reverse Stock Split became effective on October 17, 2025, and the Company’s stock began trading on a post-split basis on October 20, 2025, subsequent to the end of the reporting period ended September 30, 2025 but prior to the issuance of the financial statements as of and for the period ended September 30, 2025. The Reverse Stock Split did not affect the par value of the common stock, which remains at $
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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, 2024, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 3, 2025. 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. In February 2022, Eversense E3, a 180 day CGM system, was approved by the FDA and Ascensia Diabetes Care Holdings AG (“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 Europe 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.
Our net revenues are derived from sales of the Eversense Systems, 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.
We primarily sell directly to our network of distributors and strategic fulfillment partners, who provide the Eversense Systems to healthcare providers and patients through a prescribed request and invoice insurance payors for
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reimbursement. In addition, we sell our product on consignment through established agreements with our network of healthcare professionals. Sales of the Eversense Systems 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 (0048T) 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. All of the Medicare administrative contractors expansions became effective in 2024. 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. We have been working with payors to transition their policies to Eversense 365 and have confirmed immediate coverage policy transition from select payors.
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 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 are in the early commercialization stages of the Eversense brand and are focused on driving awareness of our CGM system amongst people with diabetes and their healthcare providers. In both the United States and our overseas markets, we have entered into strategic partnerships and distribution agreements that allow third party collaborators with direct sales forces and established distribution systems to market and promote Senseonics various Eversense Systems and future generation products, including our “Gemini” product variation to 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 smart phone to get on-demand glucose reading without a smart transmitter and our Freedom product variation which would 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
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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.
In June 2019, we received FDA approval for the non-adjunctive indication (dosing claim) for Eversense 90 and launched with an updated app in December 2019. With this approval, Eversense 90 can be used as a therapeutic CGM to replace fingerstick blood glucose measurement for treatment decisions, including insulin dosing.
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 were 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 European Economic Area (“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 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 a commercialization and collaboration agreement with Ascensia (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. 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, including the proposed termination, orderly unwinding of, and smooth transition of the commercial relationship between the Company and Ascensia (the “Proposed Transition”), which is contemplated to involve the termination of the existing Commercialization Agreement, with commercial activities expected to transition back to the Company beginning January 1, 2026 pursuant to definitive agreements we are currently negotiating with Ascensia and transition planning being undertaken by the two companies.
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 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
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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.
In an effort to accelerate commercialization efforts and address challenges to Eversense adoption, in April 2024 and July 2024, we established new legal entities, Eon Care Services, LLC and Eon Management Services, LLC, (collectively “Eon Care PCs”), which were formed as wholly owned subsidiaries of Senseonics, Incorporated. In November 2024, Eon Management Services, LLC entered into the Administrative Agreement with the Eon Care PCs, which are consolidated as VIEs. 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 through Eon Care during the second and third quarters. Once we build out and establish the Eon Care network, we expect established CPT codes associated with Eversense insertions to enable a self-sustaining economic model for this initiative in the future.
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. We expect this investment to continue into the third and fourth quarters. 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 will be utilized for an IDE submission anticipated by the end of 2025.
European Commercialization of Eversense
In September 2017, we affixed the CE mark for Eversense XL which indicates that the product may 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 Eversense 365 to our notified body for CE Mark approval. The submission was prepared in compliance with the EU medical device regulation and, upon approval, would enable the commercialization of Eversense 365 in European Union member countries. Following CE Mark approval, if received, we plan to launch Eversense 365 in European markets during the first half of 2026.
Financial Overview
Revenue
We currently generate product revenue from sales of the Eversense system and related components and supplies to Ascensia, through the Commercialization Agreement, third-party distributors outside the United States and to
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strategic fulfillment partners in the United States (collectively “Customers”), who then resell the products to health care providers and patients. We are paid for our sales directly to the Customers, regardless of whether or not 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 our network of healthcare professionals in the United States and revenue is recognized when the product is consumed by a patient. Following the expected termination of the Ascensia Commercialization Agreement we expect certain changes in this distribution channel.
Revenue from product sales is recognized at a point in time when the Customers obtain 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. Contracts with our distributors contain performance obligations, mostly for the supply of goods, and is typically satisfied upon transfer of control of the product. Customer contracts do not include the right to return 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.
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 provider locations, as we retain the ability to control the inventory. Rather, revenue is recognized when the product is consumed by a patient.
Our contracts may contain some form of variable consideration such as prompt-pay discounts, tier-volume price discounts and for the Commercialization Agreement, revenue share. Variable considerations, such as discounts and prompt-pay incentives, are treated as a reduction in revenue and variable considerations, such as revenue share, is treated as an addition in 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 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.
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 is derived from one customer, Ascensia. For the three months ended September 30, 2025 and 2024, sales to Ascensia accounted for 48% and 78% of total revenue, respectively. For the nine months ended September 30, 2025 and 2024, sales to Ascensia accounted for 56% and 84% of total revenue, respectively.
A portion of the Company’s revenue is earned under consignment arrangements with healthcare providers. For the three months ended September 30, 2025 and 2024, sales under consignment arrangements accounted for 46.5% and 20.1% of total revenue, respectively. For the nine months ended September 30, 2025 and 2024, sales under consignment arrangements accounted for 36.0% and 14.6% of total revenue, respectively. Ascensia earns a commission 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 of the Commercialization Agreement
On September 3, 2025 the Company and Ascensia signed a MOU related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company, including the Proposed Transition, which is
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contemplated to involve the termination of the existing Commercialization Agreement, with commercial activities expected to transition back to the Company beginning January 1, 2026 pursuant to a definitive agreement which the Parties are negotiating. The parties are currently planning their cooperation through the transition period to ensure continuity of supply, customer support, and patient access. As of the termination date, the Company will no longer recognize revenue associated with product sales to Ascensia under the distribution arrangement. Any remaining deferred revenue, contract assets, or liabilities associated with this agreement will be evaluated and recognized in accordance with ASC 606 based on the satisfaction (or non-satisfaction) of performance obligations as of the termination date. As a result, following the effective date of the termination of the Commercialization Agreement, 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.
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, 2025 and 2024:
| | | | | | | | | | | |
| 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 | % |
| | | | | | | | | | | |
| Three Months Ended | | Nine Months Ended | | |||||||
| September 30, 2024 | | | September 30, 2024 | | ||||||
| | | % | | | | | % | | ||
(Dollars in thousands) | Amount | | of Total | | | Amount | | of Total | | ||
Revenue, net: | | | | | | | | | | | |
United States | $ | 2,382 | | 55.9 | % | | $ | 9,089 | | 64.1 | % |
Outside of the United States | | 1,881 | | 44.1 | | | | 5,086 | | 35.9 | |
Total | $ | 4,263 | | 100.0 | % | | $ | 14,175 | | 100.0 | % |
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Results of Operations for the Three Months Ended September 30, 2025 and 2024
| | | | | | | | | |
| | Three Months Ended | | | | ||||
| | September 30, | | Period-to- | |||||
| | 2025 | | 2024 | | Period Change | |||
| | (in thousands) | | | | ||||
Revenue, net |
| $ | 4,202 |
| $ | 955 |
| $ | 3,247 |
Revenue, net - related parties | | | 3,893 | | | 3,308 | | | 585 |
Total revenue | | | 8,095 | | | 4,263 | | | 3,832 |
Cost of sales | | | 4,627 | | | 8,314 | | | (3,687) |
Gross profit (loss) | | | 3,468 | | | (4,051) | | | 7,519 |
| | | | | | | | | |
Expenses: | | | | | | | | | |
Research and development expenses | |
| 7,759 | |
| 10,546 | |
| (2,787) |
Selling, general and administrative expenses | |
| 15,310 | |
| 8,250 | |
| 7,060 |
Operating loss | |
| (19,601) | |
| (22,847) | |
| 3,246 |
Other income (expense), net: | | | | | | | | | |
Interest income | | | 1,236 | | | 1,010 | | | 226 |
Interest expense | |
| (1,171) | |
| (2,133) | |
| 962 |
Other income (expense) | |
| 6 | |
| (6) | |
| 12 |
Total other income (expense), net | |
| 71 | |
| (1,129) | |
| 1,200 |
Net Loss | | $ | (19,530) | | $ | (23,976) | | $ | 4,446 |
Total revenue
Our total revenue increased to $8.1 million for the three months ended September 30, 2025, compared to $4.3 million for the three months ended September 30, 2024, an increase of $3.8 million. This increase was primarily driven by sales growth in the US largely due to growth in the consignment program and 365-day product demand.
Cost of sales and gross profit
Our cost of sales decreased to $4.6 million for the three months ended September 30, 2025, compared to $8.3 million for the three months ended September 30, 2024 and our gross profit increased to $3.5 million for the three months ended September 30, 2025, compared to ($4.1) million for the three months ended September 30, 2024. Gross profit as a percentage of revenue, or gross margin, was 42.8% and (95.0%) for the three months ended September 30, 2025, and September 30, 2024, respectively. The improvement in gross margin is primarily due to $4.8 million in one-time charges incurred in the prior year as the result of the transition from Eversense E3 to Eversense 365. If these one-time charges were to be excluded, the prior year gross margin would be 18%. The additional improvement in the gross margin is due to several factors, including more favorable margins on the 365-day product sales and consistent fixed manufacturing costs.
Research and development expenses
Research and development expenses were $7.8 million for the three months ended September 30, 2025, compared to $10.5 million for the three months ended September 30, 2024, a decrease of $2.7 million. The decrease was driven by a $0.5 million decrease in employee services costs, a $0.7 million decrease in clinical study expenses, and a $1.5 million decrease in contract fabrication costs. These reductions are primarily driven by the completion of the Eversense 365 system clinical trials and development efforts as well as a reduction in headcount.
Selling, general and administrative expenses
Selling, general and administrative expenses were $15.3 million for the three months ended September 30, 2025, compared to $8.3 million for the three months ended September 30, 2024 an increase of $7.0 million. The increase was primarily driven by an increase of $0.3 million in selling and marketing personnel costs, $4.7
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million increase in promotional expenses as a result of investments in direct-to-consumer marketing, $0.8 million in sales commission expenses to Ascensia as we increased consignment sales, and $1.2 million in other general & administrative costs.
Total other income (expense), net
Total other income (expense), net was $0.07 million for the three months ended September 30, 2025, compared to other expense, net of ($1.1) million for three months ended September 30, 2024, an increase in other income (expense), net of $1.2 million. The change was primarily due to lower interest expense of $1.0 million primarily due to repayment of the 2025 Notes offset by an increase in total interest income of $0.2 million as the result of higher investments in marketable securities.
Results of Operations for the Nine Months Ended September 30, 2025 and 2024
| | | | | | | | | | |
| | Nine Months Ended | | | |
| ||||
| | September 30, | | Period-to- |
| |||||
| | 2025 | | 2024 | | Period Change |
| |||
| | (in thousands) | | | (in thousands) |
| ||||
Revenue, net |
| $ | 9,235 |
| $ | 2,322 |
| $ | 6,913 | |
Revenue, net - related parties | | | 11,766 | | | 11,853 | | | (87) | |
Total revenue | | | 21,001 | | | 14,175 | | | 6,826 | |
Cost of sales | | | 12,907 | | | 17,593 | | | (4,686) | |
Gross profit (loss) | | | 8,094 | | | (3,418) | | | 11,512 | |
| | | | | | | | | | |
Expenses: | | | | | | | | | | |
Research and development expenses | |
| 22,773 | |
| 31,784 | |
| (9,011) | |
Selling, general and administrative expenses | |
| 32,733 | |
| 25,369 | |
| 7,364 | |
Operating loss | |
| (47,412) | |
| (60,571) | |
| 13,159 | |
Other (expense) income, net: | | | | | | | | | | |
Interest income | | | 2,884 | | | 3,584 | | | (700) | |
Interest expense | |
| (3,745) | |
| (6,266) | |
| 2,521 | |
Gain on change in fair value of derivatives | | | — | | | 102 | | | (102) | |
Other (expense) income | |
| (17) | |
| 11 | |
| (28) | |
Total other income (expense), net | |
| (878) | |
| (2,569) | |
| 1,691 | |
Net Loss | | $ | (48,290) | | $ | (63,140) | | $ | 14,850 | |
Total revenue
Our total revenue increased to $21.0 million for the nine months ended September 30, 2025, compared to $14.2 million for the nine months ended September 30, 2024, an increase of $6.8 million. This increase was primarily driven by sales growth in the US largely due to growth in the consignment program and 365-day product demand.
Cost of sales and gross profit
Our cost of sales decreased to $12.9 million for the nine months ended September 30, 2025 compared to $17.6 million for the nine months ended September 30, 2024 and our gross profit increased to $8.1 million for the nine months ended September 30, 2025, compared to ($3.4) million for the nine months ended September 30, 2024. Gross profit as a percentage of revenue, or gross margin, was 38.5% and (24.1%) for the nine months ended September 30, 2025, and September 30, 2024, respectively. The improvement in gross margin is primarily due to $4.8 million in one-time charges incurred in the prior year as the result of the transition from Eversense E3 to Eversense 365. The additional improvement in the gross margin is due to several factors, including favorable margins on the 365-day product sales, lower fixed manufacturing costs, one-time impacts such as VAT recoveries of $0.7 million and the benefit of previously expensed inventory in the amount of $0.6 million. These improvements are slightly offset by an increase in revenue share to Ascensia under the terms of the Commercialization Agreement.
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Research and development expenses
Research and development expenses were $22.8 million for the nine months ended September 30, 2025, compared to $31.8 million for the nine months ended September 30, 2024, a decrease of $9.0 million. The decrease was primarily driven by a $5.6 million decrease in clinical study and development (contract fabrication) costs, a $2.1 million decrease in personnel costs, a $1.1 million decrease in consulting costs, and a $0.1 million decrease in other research and development expenses. These reductions are primarily driven by the completion of the Eversense 365 system clinical trials and development efforts as well as a reduction in headcount.
Selling, general and administrative expenses
Selling, general and administrative expenses were $32.7 million for the nine months ended September 30, 2025, compared to $25.4 million for the nine months ended September 30, 2024, an increase of $7.3 million. The increase was primarily driven by an increase of $4.7 million increase in promotional expenses as a result of investments in direct-to-consumer marketing, $1.6 million increase in sales commission expenses to Ascensia as we increased consignment sales, and $1.7 million increase in other general & administrative costs. These costs were offset by $0.9 million decrease in corporate legal costs.
Total other (expense) income, net
Total other expense, net was ($0.9) million for the nine months ended September 30, 2025, compared to other expense, net of ($2.6) million for the nine months ended September 30, 2024, a decrease of $1.7 million. The change was primarily due to lower interest expense of $2.5 million primarily due to repayment of the 2025 Notes offset by a decrease in interest income of $0.7 million as the result of higher investments in marketable securities and a $0.1 million derivative fair value gain.
Liquidity and Capital Resources
Sources of Liquidity
From its founding in 1996 until 2010, the Company has 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 $78.6 million and $60.4 million for the years ended December 31, 2024 and 2023, respectively. For the nine months ended September 30, 2025, the Company had a net loss of $48.3 million, and an accumulated deficit of $996.2 million. 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, 2025, the Company had unrestricted cash, cash equivalents, and marketable securities of $111.0 million.
In August 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 $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 were 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 three months ended September 30 2025, the Company received approximately $0.3 million proceeds from the sale of 68,062 shares under the Sales Agreement, after deducting sales commissions and offering expenses.
On May 15, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with several underwriters for the sale of 5,000,000 shares of its common stock (the “Public Offering”), at a public offering price of $10.00 per share (the “Public Offering Price”). Under the terms of the Underwriting Agreement, the Company
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also granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock at the Public Offering Price, which the underwriters exercised in full. The Company received aggregate gross proceeds from the Public Offering of $57.5 million. The Company also entered into a securities purchase agreement with Abbott Laboratories (“Abbott”) pursuant to which the Company agreed to issue and sell 2,026,963 shares of its common stock substantially concurrently with the Public Offering, at the Public Offering Price, to Abbott for an aggregate purchase price of approximately $20.3 million in a private placement (the “Private Placement”). The Public Offering and Private Placement closed on May 19, 2025 and May 20, 2025, respectively, and the Company received net proceeds of approximately $52.1 million and $20.1 million, respectively, after deducting underwriting discount, commissions, and offering expenses.
In the past two years, we have taken a number of measures to strengthen our financial position, including the closing of the Amended Loan and Security Agreement, repayment of our 2023 Notes, the sale of common stock in the 2024 Registered Direct Offering (as defined below) and related issuance of warrants, the issuance of a pre-funded warrant to PHC for cash in a private placement, the exchange of our PHC Notes for a newly issued pre-funded warrant, the exchange of a portion of our 2025 Notes for cash and common stock in a series of private exchanges and the repayment of the remaining 2025 Notes, and the issuance of shares of common stock pursuant to at the market offering programs. We have also taken measures to manage our operating expenses, including through a company restructuring in 2024.
On September 8, 2023, the Company entered into the “Loan and Security Agreement with Hercules Capital, Inc. and its managed fund (collectively, the “Lenders”), pursuant to which the Lenders have to make available to Senseonics up to $50.0 million in senior secured term loans (the “Term Loan Facility”), consisting of (i) an initial term loan of $25.0 million (the “Tranche 1 Loan”), which was funded on the Effective Date and (ii) $10.0 million, which was funded on January 2, 2024 upon meeting certain terms in conditions under the loan agreement, and (the “Tranche 2 Loan”) and iii) $15.0 million which has not been drawn. On September 3, 2025, the Company amended the Loan and Security Agreement (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 $50.0 million to $100.0 million (collectively, the “2025 Term Loans”). In the Amended Loan and Security Agreement, the undrawn loans increased from $15.0 million to $65.0 million divided into three tranches of up to $10.0 million (“2025 Tranche 2 Loan”), up to $20.0 million (“2025 Tranche 3 Loan”) and up to $35.0 million (“2025 Tranche 4 Loan”), respectively, which will become available to Senseonics upon Senseonics’ satisfaction of certain terms and conditions set forth in the Amended Loan and Security Agreement. The loans under the Amended Loan and Security Agreement mature on September 3, 2029.
On October 24, 2024, the Company completed a registered direct securities offering (the “2024 Registered Direct Offering”) to certain institutional investors in which we issued and sold 2,285,714 shares of common stock at $7.00 per share and simultaneously issued the PP Warrants to these investors in a private placement to purchase an aggregate of 2,285,714 shares of common stock at an exercise price of $7.00 per share. The PP Warrants were non-exercisable for the first six months after issuance and expire on April 29, 2030. The offering closed on October 28, 2024, and the Company received proceeds of approximately $14.8 million after payment of fees to the placement agent, but before payment of any additional expenses incurred by the Company in connection with the transaction.
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 $106.6 million through GS as its sales agent in an “at the market” offering. GS received commissions up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares were 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 10, 2023. On October 24, 2024, the Company amended the Equity Distribution Agreement with GS to reduce the maximum amount of shares issuable thereunder to $55.0 million. On May 15, 2025, in connection with the Public Offering and Private Placement, the Equity Distribution Agreement was terminated. At the time of termination of the Equity Distribution Agreement on May 15, 2025, the Company had received approximately $30.8 million in net proceeds from the sale of 2,006,528 shares under the Equity Distribution Agreement, after deducting sales commissions and offering expenses.
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Indebtedness
Amended Loan and Security Agreement
On September 8, 2023, the Company entered into the Loan and Security Agreement with the Lenders and Hercules, pursuant to which the Lenders agreed to make available to the Company the Term Loan Facility, consisting of (i) an initial Tranche 1 Loan, which was previously funded on the Effective Date in an amount of $25.0 million and (ii) the Tranche 2 Loan, which was funded on January 2, 2024 in an amount of $10.0 million, and (iii) Tranche 3 Loan, which has not been drawn. On September 3, 2025, the Company entered into the Amended Loan and Security Agreement, increasing the total loan commitment under the facility from $50.0 million to $100.0 million. Under the Amended Loan and Security Agreement, the undrawn loans increased from $15.0 million to $65.0 million divided into three tranches of up to $10.0 million, up to $20.0 million, and up to $35.0 million, respectively, which will become available to Senseonics upon Senseonics’ satisfaction of certain terms and conditions set forth in the Amended Loan and Security Agreement. The loans under the Amended Loan and Security Agreement mature on September 3, 2029.
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, regulatory approvals, and post-approval requirements. The Company is negotiating a definitive agreement related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company. Completion of the transfer of commercial operations relating to Eversense from Ascensia back to the Company will be subject to the terms set forth in the definitive agreement and ongoing implementation activities, which may provide opportunities to have greater influence on revenue generation and market adoption of Eversense. These activities, including our ongoing focus to grow covered lives through positive insurance payor policy decisions, initiatives to support patient access, and continued development of Eversense 365 in the United States, will require significant uses of working capital through 2025 and beyond. As of September 30, 2025, the Company had unrestricted cash, cash equivalents and marketable securities of $111.0 million.
In accordance with the FASB Accounting Standards Codification Topic 205-40, Presentation of Financial Statements-Going Concern, management is required to assess the Company’s ability to continue as a going concern through twelve months after issuance of the financial statements. Based on the Company's current operating plan including capital considerations required to assume commercialization and distribution responsibilities, existing unrestricted cash, cash equivalents and marketable securities, minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under its Amended Loan and Security Agreement, the Company has determined that substantial doubt exists regarding its ability to continue as a going concern for the one-year period following the date these condensed consolidated financial statements are issued. To sustain its future operations beyond such one-year period, the Company will require additional funding. As part of our liquidity strategy, the Company will continue to monitor our capital structure and market conditions, and the Company may finance our cash needs through public or private debt and equity financings and other sources which may include collaborations, strategic alliances, and licensing arrangements with third parties. There is no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all, and could be forced to delay, reduce, or eliminate some or all of its research, clinical trials, product development or future commercialization efforts, which could materially adversely affect its business prospects or its ability to continue as a going concern.
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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, | | ||||
|
| 2025 | | 2024 | | ||
Net cash used in operating activities |
| $ | (41,164) |
| $ | (46,219) |
|
Net cash used in investing activities | |
| (76,065) | |
| (14,828) | |
Net cash provided by financing activities | |
| 77,090 | |
| 12,759 | |
Net decrease in cash, cash equivalents and restricted cash | | $ | (40,139) | | $ | (48,288) | |
Net cash used in operating activities
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 cash used in operating activities was $46.2 million for the nine months ended September 30, 2024, and consisted of a net loss of $63.1 million, partially offset by a net change in operating assets and liabilities of $2.6 million, $7.1 million of stock-based compensation and $7.2 million related to depreciation/amortization and other non-cash items.
Net cash used in investing activities
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 purchase 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 used in investing activities was $14.8 million for the nine months ended September 30, 2024 and consisted of $58.0 million in purchase of marketable securities and $2.2 million of capital expenditures, offset by $45.4 million in proceeds from the sale and maturity of marketable securities.
Net cash provided by financing activities
Net cash provided by financing activities was $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.
Net cash provided by financing activities was $12.8 million for the nine months ended September 30, 2024, and primarily consisted of $10.0 million in proceeds from the Tranche 2 Loan and $3.8 million in proceeds from the issuance of common stock, net offset by $1.0 million from taxes paid related to net share settlement of equity awards.
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.
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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, 2025. 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, 2025, 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, 2025 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.
In May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc. vs. Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No. 2:24-cv 263. The case was filed by a non-practicing entity alleging patent infringement of three patents. The validity of all three of these patents currently is being challenged in Inter Partes Review proceedings at the U.S. Patent and Trademark Office (the “USPTO”) by another party, TikTok Inc., (the TikTok IPR”) and on September 30, 2024, the Patent Trial and Appeal Board instituted a review with respect to each of the asserted claims in these three patents. Together with LifeScan, Inc. and Ascensia, on October 30, 2024, we filed a joint motion to join the TikTok IPR as well as our own independent, similar Inter Partes Review challenges to these patents. On February 5, 2025, the court issued an order staying the proceedings in the Eastern District of Texas pending resolution of the Inter Partes Reviews. On June 5, 2025, prior to the imminent TikTok IPR final hearings, the Acting Director of the USPTO ordered a sua sponte review by the Acting Director of whether the TikTok IPR could proceed based on certain novel issues relating to TikTok’s Chinese ownership status. The Inter Partes Review proceedings are all stayed pending the outcome of the sua sponte Director’s review. The timing of this review is uncertain. Were the TikTok IPR terminated, it is our belief that our independent Inter Partes Review should continue because the issues raised in the challenge to the TikTok IPR are not relevant to our filings. Should any asserted claim in the three patents survive the invalidity challenge in the Inter Partes Review proceedings, the Company intends to vigorously defend the lawsuit.
Except as described above, we are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results or financial condition.
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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, 2024, as filed with the SEC on March 3, 2025.
Risks Relating to our Business and our Industry
The transition of commercial responsibility for Eversense to Senseonics is subject to the finalization and execution of a definitive agreement with Ascensia and, for certain European countries, an uncertain government approval process.
We recently entered into a memorandum of understanding (“MOU”) with Ascensia related to the termination of our existing Commercialization Agreement and the transfer of commercial responsibility for Eversense from Ascensia back to the Company. As contemplated by the MOU, we expect to resume responsibility for U.S. commercial activities beginning January 1, 2026 and, for non-U.S. jurisdictions, as soon as practicable thereafter. The MOU establishes the primary terms, including key financial terms, of the planned transition. However, the final terms of the definitive agreement with Ascensia remain under negotiation and the transition plans under joint development, with the final responsibility for various transition activities and liabilities still being determined. Therefore, we cannot predict with certainty the total costs that we will incur, or liabilities that we may assume, in connection with the commercial transition. If the final terms of the agreement are less favorable to us than we anticipate, it could have a material adverse effect on our ability to transition commercial responsibility for Eversense or our future results of operations.
The commercialization of Eversense in certain European countries is subject to government tender systems within the various countries. The ability of the Company to participate in the various tenders will require the satisfaction of the requirements of these countries’ regulatory bodies, and in some cases approval, which vary country by country and are further governed by specific regional level requirements within the countries. Although we are working with Ascensia and our advisors to understand these processes and the necessary requirements for each country, this process is inherently uncertain, as is the timing for receipt of any required approvals. As a result, the timeline for our eventual assumption of full commercial responsibilities in these countries is difficult to predict. Additionally, if one or more countries were to condition the transfer of a tender to the Company on terms that are less favorable than we expect, it could adversely affect the success of our European commercialization efforts.
Our resumption of commercial responsibility for Eversense will require us to develop a number of internal functions and may not be successful.
It has been more than five years since we had direct commercial responsibility for Eversense and, in order to resume commercial responsibility for the product, we will need to develop internal sales, marketing and distribution capabilities. This will require us to integrate, and in some cases, recruit, hire and train additional sales and dedicated marketing personnel, as well as other supportive functions. As a result, we expect our operating expenses to significantly increase as we resume commercial responsibility for Eversense. Although we expect to capture a larger portion of the revenue from Eversense sales following the transition, these revenue increases may not be sufficient to cover our increased operating expenses.
We have offered employment to many of the Ascensia personnel currently responsible for Eversense commercialization in the United States and plan to offer employment to additional European personnel after finalization of the definitive agreements with Ascensia and appropriate local labor law processes. However, we cannot guarantee you that we will be successful in transitioning all needed personnel to our Company or that we will not experience operational challenges and inefficiencies as we resume commercial responsibility for the product. Additionally, although we are working to transition the commercial responsibility of Eversense in a smooth manner, with minimal disruption to the supply of Eversense to patients, it is possible that health care providers, patients or tender authorities may have questions or concerns regarding the transition that could adversely affect demand for the product.
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If we encounter any of the issues described above in the transition of commercial responsibility for Eversense back to the Company, it could have a material adverse effect on our business, prospects and results of operations.
We have limited operating history as a commercial-stage company and may face difficulties encountered by companies early in their commercialization in competitive and rapidly evolving markets.
Our experience as a commercial-stage company upon which to evaluate our business, future sales expectations and operating results is limited. In assessing our business prospects, you should consider the various risks and difficulties frequently encountered by companies early in their commercialization in competitive and rapidly evolving markets, particularly companies that develop and sell medical devices. These risks include our ability to:
| ● | obtain regulatory clearance, certification or approval to commercialize our products; |
| ● | perform clinical trials with respect to current Eversense or future versions of Eversense; |
| ● | implement and execute our business strategy; |
| ● | expand and improve the productivity of our sales and marketing infrastructure to grow sales of Eversense or future versions of Eversense; |
| ● | increase awareness of our brand and Eversense and build loyalty among people with diabetes, their caregivers and healthcare providers; |
| ● | manage expanding operations; |
| ● | manage and secure effective sales of our product, including the establishment of required commercial infrastructure in the U.S. and elsewhere; |
| ● | expand the capabilities and capacities of our third-party manufacturers, including increasing production of current products efficiently and having our vendors adapt their manufacturing facilities to the production of new products; |
| ● | respond effectively to competitive pressures and developments; |
| ● | enhance Eversense and develop future versions of Eversense; and |
| ● | attract, retain and motivate qualified personnel in various areas of our business. |
Due to our limited operating history as a commercial-stage company, we may not have the institutional knowledge or experience to be able to effectively address these and other risks that may face our business. In addition, we may not be able to develop insights into trends that could emerge and negatively affect our business and may fail to respond effectively to those trends As a result of these or other risks, we may not be able to execute key components of our business strategy, and our business, financial condition and operating results may suffer.
If we are unable to successfully expand our commercialization of Eversense in the United States and Europe our business will be harmed.
We have limited commercialization experience in both the United States and Europe. We have invested substantially all of our efforts and financial resources to the development and commercialization of Eversense. Our ability to generate revenue from our products will depend heavily on successful commercialization of products in the United States and Europe and on continuing development of future generations of our Eversense system. The success of any products that we develop will depend on several factors, including:
| ● | receipt of timely marketing approvals from applicable regulatory authorities or CE Certificates Conformity from notified bodies in the EEA; |
| ● | our ability to procure and maintain suppliers and manufacturers of the components of Eversense and future versions of Eversense; |
| ● | market acceptance of Eversense by people with diabetes, the medical community and third-party payors; |
| ● | our ability to obtain and maintain coverage and adequate reimbursement for Eversense and the related insertion and removal procedures from third-party payors; |
| ● | our success in educating healthcare providers and people with diabetes about the benefits, administration and use of Eversense and future versions of Eversense; |
| ● | the prevalence and severity of adverse events experienced with Eversense and future versions of Eversense; |
| ● | the perceived advantages, cost, safety, convenience and accuracy of alternative diabetes management therapies; |
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| ● | obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for Eversense and otherwise protecting our rights in our intellectual property portfolio; |
| ● | maintaining compliance with regulatory requirements, including current good manufacturing practices; and |
| ● | maintaining a continued acceptable accuracy, safety, duration and convenience profile of Eversense. |
Our revenue is dependent, in part, upon the size of the markets in the territories for which we have regulatory approval or certification, the accepted price for the product, the ability to obtain coverage and reimbursement, and whether we own the commercial rights for that territory. If the number of people with diabetes we target is not as significant as we estimate or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products.
Approval in the United States by the FDA or approval, or certification by a regulatory agency or notified nody in another country does not guarantee approval, or certification by the regulatory authorities or notified bodies in other countries or jurisdictions or ensure approval, or certification for the same conditions of use. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Approval or certification processes vary among countries and can involve additional product testing and validation and additional administrative review periods. If we do not achieve one or more of these approvals, or certifications in a timely manner or at all, we could experience significant delays or an inability to fully commercialize Eversense and achieve profitability.
Both before and after a product is commercially released, we will have ongoing responsibilities under U.S. and EU regulations. We will also be subject to periodic inspections by the FDA, the notified bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR, of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls. These inspections can result in observations or reports, warning letters or other similar notices or forms of enforcement action. If the FDA, or any comparable foreign regulatory authority concludes that we are not in compliance with applicable laws or regulations, or that any of our products are ineffective or pose an unreasonable health risk, such authority could ban these products, suspend, vary or cancel our marketing authorizations or CE Certificates of Conformity, impose “stop-sale” and “stop-import” orders, refuse to issue export certificates, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such products, or require us to notify health providers and others that the products present unreasonable risks of substantial harm to the public health. Discovery of previously unknown problems with our product’s design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance or CE Certificate of Conformity for Eversense. The FDA, competent authorities of EEA countries and comparable foreign regulatory authorities may also impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices, assess civil or criminal penalties against our officers, employees or us, or recommend criminal prosecution of our company. Adverse regulatory action may restrict us from effectively marketing and selling our products. In addition, negative publicity and product liability claims resulting from any adverse regulatory action could have a material adverse effect on our business, financial condition, and operating results.
Foreign governmental regulations have become increasingly stringent and more extensive, and we may become subject to even more rigorous regulation by foreign governmental authorities in the future. Penalties for a company’s noncompliance with foreign governmental regulation could be severe, including revocation or suspension of a company’s business license and civil or criminal sanctions. In some jurisdictions, such as Germany, any violation of a law related to medical devices is also considered to be a violation of the unfair competition law. In such cases, governmental authorities, our competitors and business or consumer associations may then file lawsuits to prohibit us from commercializing Eversense in such jurisdictions. Our competitors may also sue us for damages. Any domestic or foreign governmental law or regulation imposed in the future may have a material adverse effect on our business, financial condition and operating results.
Our collaboration agreement with Sequel Med Tech may not lead to the benefits that we anticipate.
In April 2025, we entered into a collaboration agreement with Sequel Med Tech (the “Sequel Collaboration”), for the purpose of integrating the companies’ technologies to jointly create the first ever automated insulin delivery system with a once-yearly CGM. The development program seeks to integrate Eversense 365 and Sequel’s twiist™
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automated insulin delivery system to enable improved outcomes for people living with diabetes. We are actively working towards the integration of the companies’ products to be completed in the fourth quarter of 2025 and available to consumers shortly thereafter. The Sequel Collaboration subjects us to additional risks in our business operations, including but not limited to:
| ● | costs and expenses associated with the Sequel Collaboration, including the possibility that the costs associated with the integration of the companies’ technologies materially exceed our current expectations; |
| ● | potential distraction from other development priorities that may provide more value to the Company; |
| ● | the possibility that either party to the Sequel Collaboration may not devote sufficient financial or other resources to the collaboration, including as a result of changes to corporate priorities; |
| ● | potential technological challenges that may be experienced in the course of the collaboration, which could delay the technology integration or prevent it from being completed at all; |
| ● | potential claims for infringement, misappropriation or violation of intellectual property rights of others, which could expose us to potential litigation or other legal proceedings; |
| ● | the potential for disputes to arise between the Company and Sequel Med Tech regarding the integration of the companies’ technologies or other aspects of the Sequel Collaboration; and |
| ● | compliance with regulatory and legal requirements. |
In addition, there is no guarantee that the Sequel Collaboration will result in the financial and economic benefits we anticipate. Any of the risks listed above and other risks may cause a delay in the technology integration under the Sequel Collaboration or even prevent us from completing the project altogether. If the Sequel Collaboration is not successful or if we are unable to generate sufficient revenue as a result of the Sequel Collaboration, it could adversely affect our business and results of operations, and may damage our reputation.
International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
We operate in a global economy, and our business depends on a global supply chain for the development, manufacturing, and distribution of our products, and for the advancement of the development programs for our future generation products. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty.
We do not own or operate any manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the manufacture of our products as well as the future generations of our products under development. Currently, several of our suppliers are located outside of the United States. Tariff policies, particularly those affecting countries where our suppliers are located and medical devices generally, could materially increase our costs and reduce our profitability, including as a result of our inability to adjust pricing for our products. Although these tariff policies have not, to date, had a material effect on our production costs, recent and potential future changes in international trade policies, and medical device-specific tariffs, could present material risks to our operations and financial performance.
Recent policy discussions have included potential targeted tariffs or other trade measures specifically aimed at medical technologies as part of broader healthcare cost control or national security initiatives. Unlike consumer goods, medical devices are subject to unique regulatory constraints that make rapid supply chain adjustments particularly difficult and costly. Should additional tariffs be imposed specifically targeting medical device components, our production costs could rise significantly, and it may be difficult and costly to qualify alternative sources within another country with a lower tariff rate or within the United States, as developing and qualifying alternative sources typically requires at least several months and substantial investment and regulatory approvals. Moreover, the dynamic and unpredictable tariff and trade landscape creates substantial uncertainty and significant planning challenges for our operations. Changes in tariff classifications, country-of-origin requirements, or customs procedures can occur with limited notice. This uncertainty complicates our long-term investment decisions regarding manufacturing facilities, supply chain optimization, and research and development activities.
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Unlike many industries, our ability to pass increased costs to customers is limited by the nature of medical device pricing and reimbursement systems. Many of our products are distributed pursuant to pricing established through annual or multi-year contracts with commercial, third-party payors, and reimbursement methodologies established by government programs, such as Medicare. These arrangements typically include fixed pricing terms that were negotiated prior to the implementation of the recently announced tariffs. As a result, and depending on the timing and scope of the implementation of these tariffs, cost increases due to tariffs may be difficult or impossible to pass through to customers until the next negotiation cycle.
Current or future tariffs will also result in increased research and development expenses, including with respect to increased costs associated with raw materials, laboratory equipment and research materials and components. Trade restrictions affecting the import of materials necessary for the clinical trials of our future generation products could result in delays to our development timelines. Increased development costs and extended development timelines could place us at a competitive disadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence and negatively impact our business, results of operations, financial condition and growth prospects.
The complexity of announced or future tariffs may also increase the risk that we or our customers or suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations. Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to engage with, purchase from or invest in U.S. entities, which may limit our ability to compete internationally and attract non-U.S. investment, employees, customers and suppliers. Foreign governments may also take other retaliatory actions against U.S. entities, such as decreased intellectual property protection, increased enforcement actions, or delays in regulatory approvals, which may result in heightened international legal and operational risks. In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business.
Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects. While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition and prospects. In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described elsewhere in this report and in our Annual Report for the fiscal year ended December 31, 2024.
Risks Related to our Financial Results and Need for Financing
We will need to generate significant sales to achieve profitable operations.
We intend to continue to increase our operating expenses in connection with the commercialization of Eversense, our ongoing research and development activities including the development of next generation products and the clinical trials for those products, and the commensurate development of our management and administrative functions. We will need to generate significant sales to achieve profitability, and we might not be able to do so. Even if we do generate significant sales, we might not be able to achieve, sustain or increase profitability on a quarterly or annual basis in the future. If our sales grow more slowly than we expect, if we take on additional commercialization responsibilities for Eversense, or if our operating expenses otherwise exceed our expectations, our financial performance and operating results will be adversely affected.
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We cannot predict the ultimate effect on our common stock share price of the one-for-twenty Reverse Stock Split of our common stock that was effected on October 17, 2025. The Reverse Stock Split may decrease the liquidity of our common stock and magnify any decrease in our overall market capitalization.
The ultimate effect of the Reverse Stock Split on the market price of our common stock cannot be predicted with any certainty, and we cannot assure you that the Reverse Stock Split will result in any or all of the benefits we expect. While we expect that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of our common stock, we cannot assure you that the Reverse Stock Split will increase the market price of our common stock by a multiple of the Reverse Stock Split ratio or result in any permanent or sustained increase in the market price of our common stock. The market price of our common stock depends on multiple factors, many of which are unrelated to the number of shares outstanding, including our business and financial performance, general market conditions and prospects for future success, any of which could have a counteracting effect to the Reverse Stock Split on the per share price.
In addition, the Reverse Stock Split also reduced the total number of outstanding shares of common stock, which may lead to reduced trading for our common stock. As a result of a lower number of shares outstanding, the market for our common stock may also become more volatile. The Reverse Stock Split also increased the number of stockholders who own “odd lots” of less than 100 shares of common stock. A purchase or sale of less than 100 shares of common stock (an “odd lot” transaction) may result in incrementally higher trading costs through certain brokers, particularly “full service” brokers. Therefore, those stockholders who own fewer than 100 shares of common stock following the Reverse Stock Split may be required to pay higher transaction costs if they sell their common stock.
There is uncertainty regarding our ability to maintain sufficient liquidity to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
The financial statements in this report have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our management has concluded that the capital considerations required to assume Eversense commercialization and distribution responsibilities, our existing unrestricted cash and cash equivalents, and the minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under our Amended Loan and Security Agreement raise substantial doubts regarding our ability to continue as a going concern for the next twelve months after issuance of our the financial statements in this report.
As of September 30, 2025, the Company had unrestricted cash, cash equivalents and marketable securities of $111.0 million consisting of cash and investments in highly liquid U.S. money market funds. We do not expect our existing cash and cash equivalents will be sufficient to fund our operations, including the expanded operations that will be required to resume commercialization of Eversense, through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time. There can be no assurance that we will be successful in raising additional capital or that any needed financing will be available in the future at terms acceptable to us. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements are issued and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, and substantial doubt exists about our ability to continue as a going concern. If we are unable to secure additional capital on acceptable terms or at all, we may be required to significantly reduce or cease our operations, purse strategic alternatives, or consider other actions which could result in a loss to investors of their investment in our securities.
Risks Related to Employee Matters and Managing our Growth
Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
We are highly dependent on the management, research and development, clinical, financial and business development expertise of Tim Goodnow, our Chief Executive Officer, Rick Sullivan, our Chief Financial Officer, Mukul Jain, our Chief Operating Officer, and Ken Horton, our General Counsel and Corporate Development Advisor, as well as
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the other members of our scientific and clinical teams. Although we have employment agreements with our executive officers, each of them may terminate their employment with us at any time and will continue to be able to do so. We do not maintain “key person” insurance for any of our executives or employees.
Recruiting and retaining qualified scientific, clinical and marketing personnel are critical to our success. In addition, as we resume responsibility for the commercialization of our products, we will also be required to recruit and retain a qualified sales force and supporting functions. The loss of the services of our executive officers or other key employees, or the inability to add required staff, could impede the achievement of our research, development and commercialization objectives or the expansion of activities to support Eversense, and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous medical device companies for similar personnel, many of which have greater financial and other resources dedicated to attracting and retaining personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.
Although it will be subject to restrictions on trading, a portion of the equity of our management team will not contain other contractual transfer restrictions. This liquidity may represent material wealth to such individuals and impact retention and focus of existing key members of management.
We will need to expand our sales and marketing and potentially other capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
As of December 31, 2024, we had 117 full-time employees. As we resume responsibility for the commercialization of our products, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of sales and marketing and commercial operations. We also may experience growth in the number of employees in the areas of research, product development, clinical sciences, regulatory affairs, supply chain, logistics, clinical/insertion services, or additional commercial activities. To manage our future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
Additionally, we have and may undertake cost reduction plans, which may include reorganization of our workforce. These actions could disrupt the employee base, our ability to attract and retain qualified personnel, or cause other operational and administrative inefficiencies.
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.
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ITEM 5: Other Information
During the fiscal quarter ended September 30, 2025,
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.
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Exhibit No. | | Document |
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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). |
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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). |
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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). |
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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). |
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3.6 | | 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). |
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3.7 | | 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). |
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3.8 | | 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). |
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3.9 | | 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). |
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10.1 | | First Amendment to Loan and Security Agreement, dated September 3, 2025, by and between Senseonics Holdings, Inc. and Hercules Capital, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717) filed with the Commission on September 3, 2025). |
31.1* | | Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act. |
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31.2* | | Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act. |
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32.1** | | Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act. |
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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) |
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101.SCH* | | Inline XBRL Taxonomy Extension Schema Document |
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101.CAL* | | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF* | | Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB* | | Inline XBRL Taxonomy Extension Label Linkbase Document |
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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.
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.
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| SENSEONICS HOLDINGS, INC. | |
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Date: November 5, 2025 | By: | /s/Rick Sullivan |
| | Rick Sullivan |
| | Chief Financial Officer |
| | (Principal Financial Officer) |
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FAQ
What were Senseonics (SENS) Q3 2025 revenue and net loss?
How much cash and investments did SENS have at quarter end?
Did Senseonics disclose a going concern issue?
What changes were made to SENS’s debt facility in 2025?
What equity financing did SENS complete in 2025?
What is happening with the Ascensia Commercialization Agreement?
Did SENS execute a reverse stock split?
