Form 10-Q - Quarterly report [Sections 13 or 15(d)]

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended June 30, 2024

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission file number: 001-37717

Senseonics Holdings, Inc.

(Exact name of registrant as specified in its charter)


Delaware (State or other jurisdiction of incorporation or organization)	3841 (Primary Standard Industrial Classification Code Number)	47-1210911 (I.R.S. Employer Identification Number)

20451 Seneca Meadows Parkway

Germantown, MD 20876-7005

(301) 515-7260

(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
Common Stock, $0.001 par value	SENS	NYSE American

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. Yes ☒ No ☐

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). Yes ☒No ☐

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	☐
Non-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 ☐ No ☒

There were 535,574,088 shares of common stock, par value $0.001, outstanding as of August 02, 2024.

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TABLE OF CONTENTS

PART I: Financial Information

ITEM 1: Financial Statements

Condensed Consolidated Balance Sheets as of June 30, 2024 (Unaudited) and December 31, 2023			3
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2024 and 2023			4
Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three and six months ended June 30, 2024 and 2023			5
Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023			6
Notes to Unaudited Condensed Consolidated Financial Statements			7

ITEM 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations			26

ITEM 3: Quantitative and Qualitative Disclosures About Market Risk			37

ITEM 4: Controls and Procedures			37

PART II: Other Information			38

ITEM 1: Legal Proceedings			38

ITEM 1A: Risk Factors			38

ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds			40

ITEM 3: Defaults Upon Senior Securities			40

ITEM 4: Mine Safety Disclosures			40

ITEM 5: Other Information			40

ITEM 6: Exhibits			41

SIGNATURES			43

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Senseonics Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)


	June 30,		December 31,
	2024		2023
		(unaudited)

Assets
Current assets:
Cash and cash equivalents	$	34,853	$	75,709
Restricted cash		318		—
Short term investments, net		49,774		33,747
Accounts receivable, net		1,277		808
Accounts receivable, net - related parties		3,075		3,724
Inventory, net		7,215		8,776
Prepaid expenses and other current assets		6,502		7,266
Total current assets		103,014		130,030
Deposits and other assets		5,241		7,006
Property and equipment, net		3,306		1,184
Total assets	$	111,561	$	138,220
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,331	$	4,568
Accrued expenses and other current liabilities		11,916		11,744
Accrued expenses and other current liabilities, related parties		1,226		945
Note payable, current portion, net		18,642		—
Total current liabilities		33,115		17,257

Long-term debt and notes payables, net		34,202		41,195
Derivative liabilities		—		102
Other liabilities		6,010		6,214
Total liabilities		73,327		64,768

Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares authorized and 12,000 shares issued and outstanding as of June 30, 2024 and December 31, 2023		37,656		37,656
Total temporary equity		37,656		37,656

Commitments and contingencies

Stockholders’ equity:
Common stock, $0.001 par value per share; 1,400,000,000 shares and 900,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 535,277,362 shares and 530,364,237 shares issued and outstanding as of June 30, 2024 and December 31, 2023		535		530
Additional paid-in capital		908,472		904,535
Accumulated other comprehensive loss		(7)		(11)
Accumulated deficit		(908,422)		(869,258)
Total stockholders’ equity		578		35,796
Total liabilities and stockholders’ equity	$	111,561	$	138,220

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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Senseonics Holdings, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2024		2023		2024		2023
Revenue, net	$	778	$	437	$	1,367	$	750
Revenue, net - related parties		4,087		3,689		8,545		7,513
Total revenue		4,865		4,126		9,912		8,263
Cost of sales		4,567		3,709		9,279		7,433
Gross profit		298		417		633		830

Expenses:
Research and development expenses		10,800		12,830		21,238		25,235
Selling, general and administrative expenses		8,991		7,455		17,119		15,173
Operating loss		(19,493)		(19,868)		(37,724)		(39,578)
Other (expense) income, net:
Interest income		1,190		1,311		2,574		2,420
Exchange related gain, net		—		—		—		18,776
Interest expense		(2,085)		(2,310)		(4,133)		(6,962)
Gain on change in fair value of derivatives		102		289		102		6,067
Other (expense) income		(1)		155		17		178
Total other (expense) income, net		(794)		(555)		(1,440)		20,479

Net Loss		(20,287)		(20,423)		(39,164)		(19,099)
Other comprehensive loss
Unrealized (loss) gain on marketable securities		(5)		100		4		558
Other comprehensive (loss) gain		(5)		100		4		558
Total comprehensive loss	$	(20,292)	$	(20,323)	$	(39,160)	$	(18,541)

Basic net loss per common share	$	(0.03)	$	(0.04)	$	(0.06)	$	(0.04)
Basic weighted-average shares outstanding		616,585,664		567,125,022		615,587,105		532,499,776

Diluted net loss per common share	$	(0.03)	$	(0.04)	$	(0.06)	$	(0.04)
Diluted weighted-average shares outstanding		616,585,664		567,125,022		615,587,105		532,499,776

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)


													Series B
	Common Stock			Paid-In		Other		Accumulated		Stockholders'		Convertible
	Shares	Amount		Capital		Comprehensive Loss		Deficit		Equity (Deficit)		Preferred Stock Temporary Equity
Three months ended June 30, 2023:
Balance, March 31, 2023	479,780	$	480	$	871,746	$	(220)	$	(807,542)	$	64,464	$	37,656
Issuance of common stock, net of issuance costs	9,945		10		7,366		—		—		7,376		—
Issued common stock for vested RSUs and ESPP purchase	5,228		5		(3)		—		—		2		—
Issuance of warrants, net of issuance costs	—		—		(260)		—		—		(260)		—
Exercise of stock options and warrants	6		—		3		—		—		3		—
Stock-based compensation expense	—		—		2,870		—		—		2,870		—
Shares withheld related to net share settlement of equity awards	(2,132)		(2)		(1,596)		—		—		(1,598)		—
Other	—		—		3		—		—		3		—
Net loss	—		—		—		—		(20,423)		(20,423)		—
Other comprehensive income, net of tax	—		—		—		100		—		100		—
Balance, June 30, 2023	492,827		493		880,129		(120)		(827,965)		52,537		37,656

Six months ended June 30, 2023:
Balance, December 31, 2022	479,637	$	480	$	806,488	$	(678)	$	(808,866)	$	(2,576)	$	37,656
Issuance of common stock, net of issuance costs	9,945		10		7,366		—		—		7,376		—
Issued common stock for vested RSUs and ESPP purchase	5,371		5		82		—		—		87		—
Issuance of warrants, net of issuance costs	—		—		63,282		—		—		63,282		—
Exercise of stock options and warrants	6		—		3		—		—		3		—
Stock-based compensation expense	—		—		4,651		—		—		4,651		—
Shares withheld related to net share settlement of equity awards	(2,132)		(2)		(1,601)		—		—		(1,603)		—
Other	—		—		(142)		—		—		(142)		—
Net loss	—		—		—		—		(19,099)		(19,099)		—
Other comprehensive income, net of tax	—		—		—		558		—		558		—
Balance, June 30, 2023	492,827	$	493	$	880,129	$	(120)	$	(827,965)	$	52,537	$	37,656

Three months ended June 30, 2024:
Balance, March 31, 2024	530,818	$	530	$	906,569	$	(2)	$	(888,135)	$	18,962	$	37,656
Issuance of common stock, net of issuance costs	620		1		—		—		—		1		—
Issued common stock for vested RSUs and ESPP purchase	6,122		6		—		—		—		6		—
Issuance of warrants, net of issuance costs	—		—		—		—		—		—		—
Exercise of stock options and warrants	11		—		5		—		—		5		—
Stock-based compensation expense	—		—		2,926		—		—		2,926		—
Shares withheld related to net share settlement of equity awards	(2,294)		(2)		(1,028)		—		—		(1,030)		—
Net loss	—		—		—		—		(20,287)		(20,287)		—
Other comprehensive loss, net of tax	—		—		—		(5)		—		(5)		—
Balance, June 30, 2024	535,277	$	535	$	908,472	$	(7)	$	(908,422)	$	578	$	37,656

Six months ended June 30, 2024:
Balance, December 31, 2023	530,364	$	530	$	904,535	$	(11)	$	(869,258)	$	35,796	$	37,656
Issuance of common stock, net of issuance costs	728		1		(1)		—		—		—		—
Issued common stock for vested RSUs and ESPP purchase	6,489		6		95		—		—		101		—
Issuance of warrants, net of issuance costs	—		—		149		—		—		149		—
Exercise of stock options and warrants	12		—		6		—		—		6		—
Stock-based compensation expense	—		—		4,727		—		—		4,727		—
Shares withheld related to net share settlement of equity awards	(2,316)		(2)		(1,039)		—		—		(1,041)		—
Net loss	—		—		—		—		(39,164)		(39,164)
Other comprehensive loss, net of tax	—		—		—		4		—		4		—
Balance, June 30, 2024	535,277	$	535	$	908,472	$	(7)	$	(908,422)	$	578	$	37,656

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)


	Six Months Ended
	June 30,
	2024		2023
Cash flows from operating activities
Net loss	$	(39,164)	$	(19,099)
Adjustments to reconcile net (loss) income to net cash used in operating activities:
Depreciation and ROU amortization expense		513		454
Non-cash interest expense (debt discount and deferred costs)		1,848		2,014
Net amortization of premiums and accretion of discounts on marketable securities		(282)		1,412
Gain on change in fair value of derivatives		(102)		(6,067)
Exchange related gain, net		—		(18,776)
Stock-based compensation expense		4,727		4,651
Provision for inventory obsolescence		52		(65)
Other		341		55
Changes in assets and liabilities:
Accounts receivable		115		(1,224)
Prepaid expenses and other current assets		765		(314)
Inventory		1,509		(1,823)
Deposits and other assets		1,596		(26)
Accounts payable		(3,296)		556
Accrued expenses and other liabilities		348		493
Accrued interest		76		357
Operating lease liabilities		(450)		(430)
Net cash used in operating activities		(31,404)		(37,832)
Cash flows from investing activities
Capital expenditures		(2,408)		(57)
Purchase of marketable securities		(49,637)		(61,818)
Proceeds from sale and maturity of marketable securities		33,895		87,746
Net cash provided by (used in) investing activities		(18,150)		25,871
Cash flows from financing activities
Proceeds from issuance of common stock, net		—		7,376
Proceeds from exercise of stock options and ESPP issuances, net		107		(52)
Proceeds from issuance of term loan, net		9,950		—
Taxes paid related to net share settlement of equity awards		(1,041)		(1,603)
Repayment of 2023 Notes		—		(15,700)
Proceeds from issuance of warrants, net		—		14,698
Net cash provided by financing activities		9,016		4,719
Net decrease in cash, cash equivalents		(40,538)		(7,242)
Cash, cash equivalents, and restricted cash at beginning of period		75,709		35,793
Cash, cash equivalents, and restricted cash at ending of period	$	35,171	$	28,551

Supplemental disclosure of cash flow information
Cash paid during the period for interest	$	2,209	$	1,756
Lease liabilities arising from obtaining right-of-use assets		—		3,831
Supplemental disclosure of non-cash investing and financing activities
Property and equipment purchases included in accounts payable and accrued expenses		37		—
Issuance of warrants in exchange for PHC Notes		—		48,564
Issuance of warrants for Loan and Security Agreement		149		—

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

Senseonics Holdings, Inc., a Delaware corporation, is a medical technology company focused on the development and manufacturing 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 and will commence operations later this year. Senseonics Holdings, Inc., Senseonics, Incorporated, Eon Care Services, LLC and Eon Management Services, LLC are hereinafter collectively referred to as the “Company” unless otherwise indicated or the context otherwise requires.

2.	Liquidity and Capital Resources

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) income of ($60.4) million and $142.1 million for the years ended December 31, 2023 and 2022, respectively. For the six months ending June 30, 2024, the Company had gross profit of $0.6 million and an accumulated deficit of $908.4 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 June 30, 2024, the Company had unrestricted cash, cash equivalents and marketable securities of $84.6 million.

The Company’s ability to grow revenues and achieve profitability depends on the successful commercialization and adoption of our Eversense CGM systems by diabetes patients and healthcare providers, along with future product development, regulatory approvals, and post-approval requirements. These activities and continued development of the Gemini product, Freedom product and other future products, will require significant uses of working capital through 2024 and beyond.

In accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification, 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, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, and minimum cash and satisfaction of performance milestones to comply with debt covenants under its 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 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, we will continue to monitor our capital structure and market conditions, and we 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. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the condensed consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and that contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

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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 have agreed to make available to the Company 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) two additional tranches of term loans in the amounts of up to $10.0 million (the “Tranche 2 Loan”) and $15.0 million (the “Tranche 3 Loan”), respectively, which will become available to the Company upon the Company’s satisfaction of certain terms and conditions set forth in the Loan and Security Agreement. In December 2023, we met the terms and conditions to draw on the Tranche 2 Loan and the loan was funded on January 2, 2024 in an amount of $10.0 million. The loans under the Loan and Security Agreement mature on September 1, 2027 (the “Maturity Date”).

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 5.25% Convertible Senior Notes due 2025 (the “2025 Notes”). Under the terms of the Exchange Agreements, the Noteholders agreed to exchange with the Company (the “Exchanges”) up to $30.8 million in aggregate principal amount of the 2025 Notes (the “Exchanged Notes”) for a combination of $7.5 million of cash and newly issued shares of common stock (the “Exchange Shares”). The number of Exchange Shares was determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period commencing on August 11, 2023 and ending August 31, 2023. Based on the volume-weighted average price per share of the common stock during the averaging period, a total of 35.1 million shares of common stock were issued in the Exchanges. The Exchanges were settled on the initial share issuance date of August 14, 2023 and the final settlement date of September 5, 2023.

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, which represented the remaining capacity under our then-existing at the market program with Jefferies LLC (“Jefferies”), as described below. GS will receive a commission up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares will be offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on August 10, 2023. As of June 30, 2024, the Company received approximately $0.3 million in net proceeds from the sale of 728,291 shares under the Equity Distribution Agreement.

In November 2021, we entered into the 2021 Sales Agreement with Jefferies, under which we could offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million through Jefferies as our sales agent in an “at the market” offering. Jefferies received commissions up to 3.0% of the gross proceeds of any common stock sold through Jefferies under the 2021 Sales Agreement. During 2023, the Company received $7.4 million in net proceeds from the sale of 9,944,663 shares of its common stock under the 2021 Sales Agreement. Effective August 7, 2023, the Company and Jefferies mutually agreed to terminate the 2021 Sales Agreement. At the time of termination, approximately $106.6 million remained available for issuance pursuant to the 2021 Sales Agreement.

On August 9, 2020, the Company entered into a financing agreement with the parent company of Ascensia Diabetes Care Holdings AG (“Ascensia”), PHC Holdings Corporation (“PHC”), pursuant to which the Company issued $35.0 million in aggregate principal amount of Senior Secured Convertible Notes due on October 31, 2024 (the “PHC Notes”), to PHC. The Company also issued 2,941,176 shares of common stock to PHC as a financing fee. The Company also has the option to sell and issue PHC up to $15.0 million of convertible preferred stock on or before December 31, 2022, contingent upon obtaining U.S. Food and Drug Administration (“FDA”) approval for the 180-day Eversense product for marketing in the United States before such date. The Company successfully obtained FDA approval in February 2022 and the option was not exercised. As described in Note 12, on March 13, 2023, the Company entered into an Exchange Agreement (the “PHC Exchange Agreement”) with PHC, pursuant to which PHC agreed to exchange (the

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“PHC Exchange”) its $35.0 million aggregate principal amount of the PHC Notes, including all accrued and unpaid interest thereon, for a warrant (the “PHC Exchange Warrant”) to purchase up to 68,525,311 shares of the Company’s common stock, $0.001 par value per share (the “PHC Exchange Warrant Shares”). The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per PHC Exchange Warrant Share. On March 31, 2023, (6:00 am Japan Standard Time on April 1, 2023) the PHC Exchange was consummated, and the Company issued the PHC Exchange Warrant in consideration for the cancellation of the PHC Notes.

On March 13, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with PHC, pursuant to which the Company issued and sold to PHC in a private placement (the “Private Placement”) a warrant (the “Purchase Warrant”) to purchase 15,425,750 shares of the Company’s common stock, $0.001 par value per share (the “Purchase Warrant Shares”). The purchase price of the Purchase Warrant was approximately $0.97 per Purchase Warrant Share, representing the undiscounted, trailing 10-day volume weighted average price of the Company’s common stock through March 10, 2023. The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per Purchase Warrant Share. The issuance of the Purchase Warrants enabled PHC to maintain, as of the closing of the transaction, a 15% beneficial ownership for purposes of the Investor Rights Agreement, dated August 9, 2020, between the Company and PHC. The Private Placement closed on March 13, 2023 (the “Private Placement Closing Date”) and the Company received aggregate gross proceeds of $15.0 million, before deducting private placement expenses payable by the Company.

3.	Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“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 June 30, 2024, and December 31, 2023, results of operations, comprehensive income (loss), and changes in stockholder’s deficit for the three and six months ended June 30, 2024 and 2023 and cash flows for the six months ended June 30, 2024 and 2023 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, 2023, as filed with the SEC on March 1, 2024. The interim results for June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, 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 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, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, and minimum cash and satisfaction of performance milestones to comply with debt covenants under its 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 wholly owned operating subsidiary Senseonics, Incorporated. The Company views its operations and manages its business in one segment, glucose monitoring products. Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.

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Recent Accounting Pronouncements

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires that an entity report segment information in accordance with Topic 280, Segment Reporting. The amendment in the ASU is intended to improve reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses. The amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, on a retrospective basis, with early adoption permitted. The Company is currently evaluating the impact of the new standard on its financial statements and disclosures.

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 fiscal years beginning after December 15, 2024, or our fiscal year 2025, using either a prospective or retrospective transition method, and early adoption is permitted. The Company is currently evaluating the impact of the new standard on its financial statements and disclosures.

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses during the reporting period. In the accompanying unaudited consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, recoverability of long-lived 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, 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.

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, 2023.

4. Revenue Recognition

The Company generates product revenue from sales of the Eversense system and related components and supplies to Ascensia, through a collaboration and commercialization agreement (the “Ascensia 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’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, 2023.

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Revenue by Geographic Region

The following table sets forth net revenue derived from the Company’s two primary geographical markets, the United States and outside of the United States, based on the geographic location to which the Company delivers the product, for the three and six months ended June 30, 2024 and 2023:


	Three Months Ended				Six Months Ended
	June 30, 2024				June 30, 2024
			%				%
(Dollars in thousands)	Amount		of Total		Amount		of Total
Revenue, net:
United States	$	3,030	62.3	%	$	6,706	67.7	%
Outside of the United States		1,835	37.7			3,206	32.3
Total	$	4,865	100.0	%	$	9,912	100.0	%


	Three Months Ended				Six Months Ended
	June 30, 2023				June 30, 2023
			%				%
(Dollars in thousands)	Amount		of Total		Amount		of Total
Revenue, net:
United States	$	1,793	43.5	%	$	3,955	47.9	%
Outside of the United States		2,333	56.5			4,308	52.1
Total	$	4,126	100.0	%	$	8,263	100.0	%

Contract Assets

Contract assets consist of unbilled receivables from customers and are recorded at net realizable value and relate to the revenue share variable consideration from the Ascensia Commercialization Agreement. Accounts receivable – related parties, net as of June 30, 2024 and December 31, 2023 included unbilled accounts receivable of $ 0.9 million and $1.5 million, respectively. The Company expects to invoice and collect all unbilled accounts receivable within 12 months.

Concentration of Revenue and Customers

For the three months ended June 30, 2024 and 2023, the Company derived 84% and 89%, respectively, of its total revenue from one customer, Ascensia. Revenues for these corresponding periods represent sales of sensors, transmitters and miscellaneous Eversense system components.

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 83,951,061 shares of common stock issuable upon the exercise of the PHC Exchange Warrant Shares and the Purchase Warrant Shares held by PHC are included in the number of outstanding shares used for the computation of basic net loss per share for the three and six months ended June 30, 2024 and 2023. Since the shares are issuable for little or no consideration, sometimes referred to as “penny warrants”, they are considered outstanding in the context of earnings per share, as discussed in ASC 260-10-45-13.

Dilutive 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

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shares issuable from restricted stock units, stock options, warrants and the Company’s convertible notes. Potentially dilutive common shares issuable upon vesting of restricted stock units and exercise of stock options and 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:


		Three Months Ended June 30,				Six Months Ended June 30,
		2024		2023		2024		2023

Net loss	$	(20,287)	$	(20,423)	$	(39,164)	$	(19,099)

Impact of conversion of dilutive securities		—		—		—		—

Dilutive Net loss	$	(20,287)	$	(20,423)	$	(39,164)	$	(19,099)

Net loss per share
Basic	$	(0.03)	$	(0.04)	$	(0.06)	$	(0.04)
Diluted	$	(0.03)	$	(0.04)	$	(0.06)	$	(0.04)

Basic weighted average shares outstanding		616,585,664		567,125,022		615,587,105		532,499,776
Dilutive potential common stock outstanding
Dilutive potential common stock outstanding		—		—		—		—
Diluted weighted average shares outstanding		616,585,664		567,125,022		615,587,105		532,499,776

Outstanding anti-dilutive securities not included in the diluted net loss per share calculations were as follows:


	Three Months Ended June 30,		Six Months Ended June 30,
	2024	2023	2024	2023
Stock-based awards	44,689,681	31,785,464	44,689,681	31,785,464
2025 Notes	15,813,176	39,689,142	15,813,176	39,689,142
Energy Capital Preferred Shares	30,372,058	30,372,058	30,372,058	30,372,058
Warrants	1,608,070	427,821	1,608,070	427,821
Total anti-dilutive shares outstanding	92,482,985	102,274,485	92,482,985	102,274,485

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6.	Marketable Securities

Marketable securities available for sale, were as follows (in thousands):


	June 30, 2024
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Market
	Cost		Gains		Losses		Value
Commercial Paper	$	11,783	$	—	$	(8)	$	11,775
Government and agency securities		37,998		1		—		37,999
Total	$	49,781	$	1	$	(8)	$	49,774


	December 31, 2023
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Market
	Cost		Gains		Losses		Value
Commercial Paper	$	7,598	$	—	$	—	$	7,598
Corporate debt securities		7,980		1		—		7,981
Government and agency securities		18,180		—		(12)		18,168
Total	$	33,758	$	1	$	(12)	$	33,747

The following are the scheduled maturities as of June 30, 2024 (in thousands):


	Net		Fair
	Carrying Amount		Value
2024 (remaining six months)	$	49,781	$	49,774
Total	$	49,781	$	49,774

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 June 30, 2024 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.

7. Inventory, net

Inventory, net of reserves, consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Finished goods	$	1,209	$	2,160
Work-in-process		4,766		5,332
Raw materials		1,240		1,284
Total	$	7,215	$	8,776

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The Company recorded less than $0.1 million in cost of sales for the three and six months ended June 30, 2024 and the three and six months ended June 30, 2023 to reduce the value of inventory for items that are potentially obsolete due to expiry, in excess of product demand, or to adjust costs to their net realizable value.

8. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Contract manufacturing⁽¹⁾	$	3,571	$	4,244
Tax credits receivable⁽²⁾		1,793		1,793
Insurance		487		73
Clinical and Preclinical		304		343
IT and software		125		242
Rent and utilities		99		122
Sales and Marketing		70		20
Investor Relations		39		—
Research and development		14		95
Interest receivable		—		272
Accounting and Audit		—		61
Other		—		1
Total prepaid expenses and other current assets	$	6,502	$	7,266

(1)

Includes deposits to contract manufacturers for manufacturing process.

(2)

Refundable employee retention credits, enacted under the CARES Act.

9.	Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Research and development	$	4,515	$	3,846
Compensation and benefits		2,771		4,799
Professional and administrative services		2,208		673
Contract manufacturing		1,024		1,457
Interest on notes payable		780		704
Sales and marketing services		577		301
Product warranty and replacement obligations		459		514
Accrued construction and renovation costs		399		—
Operating lease		398		368
Other		11		27
Total accrued expenses and other current liabilities	$	13,142	$	12,689

10.

Leases

The Company leases approximately 33,000 square feet of research and office space for its corporate headquarters under a non-cancelable operating lease. In May 2023, the Company amended our lease, extending the lease term through May 31, 2033, and obtained a tenant improvement allowance of $1.3 million. The Company accounted for the amendment as a lease modification and remeasured the ROU asset and lease liability as of the amendment date, which resulted in an increase of $2.5 million to the ROU asset, and an increase of $3.8 million to the lease liability. The Company has one option to extend the term for an additional period of five years beginning on June 1, 2033. The rent expense is recognized on a straight-line basis through the end of the lease term, excluding option renewals. The difference between the straight-line rent amounts and amounts payable under the lease is recorded as deferred rent.

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Operating lease expense for both the six months ended June 30, 2024 and 2023 was $0.4 million.

The following table summarizes the lease assets and liabilities as of June 30, 2024 and December 31, 2023 (in thousands):


				June 30,		December 31,
Operating Lease Assets and Liabilities	Balance Sheet Classification		2024		2023
Assets
Operating lease ROU assets		Deposits and other assets	$	5,012	$	5,180
Liabilities
Current operating lease liabilities		Accrued expenses and other current liabilities	$	398	$	368
Non-current operating lease liabilities		Other non-current liabilities		6,010		6,214
Total operating lease liabilities			$	6,408	$	6,582

The following table summarizes the maturity of undiscounted payments due under operating lease liabilities and the present value of those liabilities as of June 30, 2024 (in thousands):


2024 (remaining 6 months)	$	461
2025		939
2026		967
2027		996
2028		1,026
Thereafter		4,908
Total		9,297
Less: Present value adjustment		(2,889)
Present value of lease liabilities	$	6,408

The following table summarizes the weighted-average lease term and weighted-average discount rate as of June 30, 2024:


Remaining lease term (years)	2024
Operating leases	8.9
Discount rate
Operating leases	8.5	%

11.

Product Warranty Obligations

The Company provides a warranty of one year on its smart transmitters. Additionally, the Company may also replace Eversense system components that do not function in accordance with the product specifications. Estimated replacement costs are recorded at the time of shipment as a charge to cost of sales in the consolidated statement of operations and are developed by analyzing product performance data and historical replacement experience, including comparing actual replacements to revenue.

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The warranty reserve was $0.5 million for each June 30, 2024 and December 31, 2023. The following table provides a reconciliation of the change in estimated warranty liabilities for the six months ended June 30, 2024, and for the twelve months ended December 31, 2023 (in thousands):


	June 30,		December 31,
	2024		2023
Balance at beginning of the period	$	514	$	781
Provision for warranties during the period		125		242
Settlements made during the period		(180)		(509)
Balance at end of the period	$	459	$	514

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 have agreed 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) two additional tranches of term loans in the amounts of up to $10.0 million (the “Tranche 2 Loan”) and $15.0 million (the “Tranche 3 Loan”), respectively, which will become available to Senseonics upon Senseonics’ satisfaction of certain terms and conditions set forth in the Loan and Security Agreement. In December 2023, the Company met the terms and conditions to draw on Tranche 2 Loan and the loan was funded on January 2, 2024 in an amount of $10.0 million. The loans under the Loan and Security Agreement mature on September 1, 2027 (the “Maturity Date”).

The loans under the 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 1.40% and (ii) 9.90%. Borrowings under the Loan and Security Agreement are repayable in monthly interest-only payments through (a) initially, September 1, 2026 and (b) if the Company satisfies the Interest Only Extension Conditions (as defined in the Loan and Security Agreement), the Maturity Date. After the interest-only payment period, borrowings under the Loan and Security Agreement are repayable in equal monthly payments of principal and accrued interest until the Maturity Date.

At the Company’s option, the Company may prepay all or any portion of the outstanding borrowings under the Loan and Security Agreement, subject to a prepayment fee equal to (a) 3.0% of the principal amount being prepaid if the prepayment occurs within one year of the Effective Date, 2.0% of the principal amount being prepaid if the prepayment occurs during the second year following the Effective Date, and 1.00% of the principal amount being prepaid if the prepayment occurs more than two years after the Effective Date and prior to the Maturity Date. In addition, the Company paid a $375,000 facility fee upon closing and will pay additional facility charges in connection with any borrowing of the Tranche 2 Loan or Tranche 3 Loan, in each case in the amount of 0.50% of the amount of such tranche of loans. The Loan and Security Agreement also provides for an end of term fee in an amount equal to 6.95% of the aggregate principal amount of loan advances actually made under the Loan and Security Agreement, which fee is due and payable on the earliest to occur of (i) the Maturity Date, (ii) the date the Company prepays the outstanding loans in full, and (iii) the date that the secured obligations become due and payable. The end of term fee is accreted to interest expense over the term of the loans.

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The Company’s obligations under the Loan and Security Agreement are secured, by a first-priority security interest in substantially all of its assets. The Loan and Security Agreement contains a minimum cash covenant that requires the Company to hold unrestricted cash equal to 30% of the outstanding loan amount under the Loan and Security Agreement. The Loan and Security Agreement also contains a performance covenant, commencing on July 1, 2024, that requires the Company to generate net product revenue on a trailing six-month basis in excess of specified percentage for applicable measuring periods, subject to certain exceptions.

In addition, the 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 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 4.0% may be applied to the outstanding amount, and the Lenders will have the right to accelerate all amounts outstanding under the Loan and Security Agreement, in addition to other remedies available to them as secured creditors of the Company.

In addition, in connection with the issuance of the Tranche 1 Loan, the Company issued warrants to the Lenders (collectively, the “Warrants”) to acquire an aggregate of 832,362 shares of the Company’s common stock at an exercise price of $0.6007 per share (the “Warrant Shares”). The Warrants may be exercised through the earlier of (i) the seventh anniversary of the Effective Date and (ii) the consummation of certain acquisition transactions involving the Company, as set forth in the Warrants. The number of Warrant Shares for which the Warrants are exercisable, and the associated exercise price are subject to certain customary proportional adjustments for fundamental events, including stock splits and reverse stock splits, as set forth in the Warrants. The proceeds from the Loan and Security Agreement were allocated between the Tranche 1 Loan and the Warrants based on their respective fair value of $25.0 million and $0.4 million, and the amount allocated to the Warrants was recorded in equity resulting in a debt discount to the Tranche 1 Loan that is being amortized as additional interest expense over the term of the Loan and Security Agreement using the effective interest method. On January 2, 2024, in connection with the issuance of the Tranche 2 Loan the Company issued additional warrants to the Lenders (collectively, the Tranche 2 Warrants”) to acquire an aggregate of 347,887 shares at an exercise price of $0.5749 per share (the “Tranche 2 Warrant Shares”).

In connection with Loan and Security Agreement, the Company incurred $1.1 million in debt issuance costs and debt discounts which are netted against the principal balance of the initial term loan and amortized as interest expense over the term of the initial term loan using an effective interest rate of 12.92%.

Pursuant to the Loan and Security Agreement, the Company also agreed to issue additional seven year term warrants upon the funding of the Tranche 3 Loan, which warrants would be exercisable for an aggregate number of shares equal to 2.0% of the funded loan amount divided by the exercise price equal to the three-day volume-weighted average price at the time of each advance.

Convertible Preferred Stock and Warrants

Securities Purchase Agreement

On March 13, 2023, pursuant to the Securities Purchase Agreement with PHC, the Company issued and sold to PHC in a private placement a warrant (the “Purchase Warrant”) to purchase 15,425,750 shares of common stock (the “Purchase Warrant Shares”). The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per Purchase Warrant Share. On the Private Placement Closing Date, the Company received aggregate gross proceeds of $15.0 million, before deducting private placement expenses payable by the Company. All or any part of the Purchase Warrant is exercisable by the holder at any time and from time to time.

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The Company determined that the Purchase Warrant shall be classified as equity in accordance with ASC Topic 480, Distinguishing Liabilities from Equity and ASC Topic 815. At issuance, the Company recorded the estimated fair value of the Purchase Warrant in the amount of $14.3 million as additional paid-in-capital in the Company’s consolidated balance sheets.

Because PHC was an existing stockholder of the Company at the time of the transaction, the $0.7 million excess of the purchase price over the fair value of the Purchase Warrant was recognized as an equity transaction and recorded as a capital contribution made by PHC to the Company as additional paid-in-capital in the Company’s consolidated balance sheets.

Additionally, on March 13, 2023, the Company entered into the Exchange Agreement with PHC, pursuant to which PHC agreed to exchange (the “PHC Exchange”) its $35.0 million aggregate principal amount of the PHC Notes, including all accrued and unpaid interest thereon, for a warrant (the “PHC Exchange Warrant”) to purchase up to 68,525,311 shares of common stock (the “PHC Exchange Warrant Shares”). The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per PHC Exchange Warrant Share. All or any part of the PHC Exchange Warrant is exercisable by the holder at any time and from time to time. The number of PHC Exchange Warrant Shares represents the number of shares of common stock previously issuable upon conversion of the PHC Notes, in accordance with the original terms of the notes, including a number of shares in respect of accrued and unpaid interest through the closing date, plus additional shares with a value of $675,000 reflecting a portion of the future interest payments forgone by PHC. On March 31, 2023 (6:00 am Japan Standard Time on April 1, 2023), the PHC Exchange was consummated, and the Company issued the PHC Exchange Warrant in consideration for the cancellation of the PHC Notes.

The Company determined that the PHC Exchange Warrant shall be classified as equity in accordance with ASC 480 and ASC 815. On March 31, 2023, the Company recorded the estimated fair value of the PHC Exchange Warrant in the amount of $48.6 million as additional paid-in-capital in the Company’s consolidated balance sheets.

As of June 30, 2024, the Purchase Warrant and the PHC Exchange Warrant remained unexercised and outstanding. As they are prefunded warrants, the Company included the entirety of the warrant shares as weighted average outstanding shares in the calculation of its basic earnings per share.

Convertible Notes

PHC Notes

On August 9, 2020, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”) with PHC, as the purchaser (together with the other purchasers from time-to-time party thereto, the “Note Purchasers”) and Alter Domus (US) LLC, as collateral agent. Pursuant to the Note Purchase Agreement, the Company borrowed $35.0 million in aggregate principal through the issuance and sale of the PHC Notes on August 14, 2020 (the “Closing Date”). The Company also issued 2,941,176 shares of its common stock, $0.001 par value per share to PHC as a financing fee (the “Financing Fee Shares”) on the Closing Date. The Financing Fee Shares are accounted for as debt discount in the amount of $1.5 million.

The PHC Notes were senior secured obligations of the Company and were guaranteed on a senior secured basis by the Company’s wholly owned subsidiary, Senseonics, Incorporated. Interest at the initial annual rate of 9.5% is payable semi-annually in cash or, at the Company’s option, payment in kind. The interest rate decreased to 8.0% in April 2022 as a result of the Company having obtained FDA approval for the 180-day Eversense E3 system for marketing in the United States. The maturity date for the PHC Notes was October 31, 2024 (the “Maturity Date”). The obligations under the PHC Notes were secured by substantially all of the Company’s and its subsidiary’s assets.

Each $1,000 of principal of the PHC Notes (including any interest added thereto as payment in kind) was convertible into 1,901.7956 of shares of the Company’s stock, equivalent to a conversion price of approximately $0.53 per share, subject to specified anti-dilution adjustments, including adjustments for the Company’s issuance of equity securities on or prior to April 30, 2022 below the conversion price. In addition, following a notice of redemption or

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certain corporate events that occurred prior to the maturity date, the Company would have been required to pay cash in lieu of delivering make whole shares unless the Company obtained stockholder approval to issue such shares.

Subject to specified conditions, on or after October 31, 2022, the PHC Notes would have become redeemable by the Company if the closing sale price of the common stock were to exceed 275% of the conversion price for a specified period of time and subject to certain conditions upon 10 days prior written notice at a cash redemption price equal to the then outstanding principal amount (including any payment in kind interest which has been added to such amount), plus any accrued but unpaid interest. On or after October 31, 2023, the PHC Notes would have become redeemable by the Company upon 10 days prior written notice at a cash redemption price equal to the then outstanding principal amount (including any payment in kind interest which had been added to such amount), plus any accrued but unpaid interest, plus a call premium of 130% if redeemed at least six months prior to the Maturity Date or a call premium of 125% if redeemed within six months of the Maturity Date.

The Note Purchase Agreement contained customary terms and covenants, including financial covenants, such as operating within an approved budget and achieving minimum revenue and liquidity targets, and negative covenants, such as limitations on indebtedness, liens, mergers, asset transfers, certain investing activities and other matters customarily restricted in such agreements. Most of these restrictions were subject to certain minimum thresholds and exceptions. The Note Purchase Agreement also contained customary events of default, after which the PHC Notes would have become due and payable immediately, including defaults related to payment compliance, material inaccuracy of representations and warranties, covenant compliance, material adverse changes, bankruptcy and insolvency proceedings, cross defaults to certain other agreements, judgments against the Company, change of control or delisting events, termination of any guaranty, governmental approvals, and lien priority.

The Company also had the option to sell and issue PHC up to $15.0 million of convertible preferred stock on or before December 31, 2022 (the “PHC Option”), which was initially contingent upon obtaining FDA approval for the 180-day Eversense product for marketing in the United States before such date, and which approval the Company successfully obtained in February 2022. The PHC option was not exercised and expired on December 31, 2022 and the Company recognized a loss on extinguishment of $0.1 million.

The Note Purchase Agreement also contained several provisions requiring bifurcation as a separate derivative liability including an embedded conversion feature, mandatory prepayment upon event of default that constitutes a breach of the minimum revenue financial covenant, optional redemption upon an event of default, change in interest rate after PMA approval and default interest upon an event of default. On the date of issuance, the Company recorded the fair value of the embedded features in the amount of $25.8 million as a derivative liability in the Company’s consolidated balance sheets in accordance with ASC 815. The derivative was adjusted to fair value at each reporting period, with the change in the fair value recorded in change in fair value of derivatives that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss.

In connection with the issuance of the PHC Notes, the Company incurred $2.9 million in debt issuance costs and debt discounts. The associated debt issuance costs were recorded as a contra liability in the amount of $1.4 million and were deferred and amortized as additional interest expense over the term of the notes at an effective interest rate of 29.19%. There were no conversions of the PHC Notes prior to the exchange of the PHC Notes for the PHC Exchange Warrant described above.

As described above, the PHC Exchange Agreement with PHC was consummated on March 31, 2023, whereby PHC exchanged the PHC Notes in $35.0 million principal amount and all accrued and unpaid interest for the PHC Exchange Warrant. On March 31, 2023, the Company was released from its obligation under the PHC Notes.

Upon execution of the PHC Exchange Agreement, the exercise of the original conversion feature of the PHC Notes became remote. Accordingly, the Company remeasured the embedded derivative to its fair value of $0. The Company recognized a change in fair value of the embedded derivative of $44.2 million in the caption “Exchange related gain (loss), net” that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss.

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The Company accounted for the PHC Exchange as an extinguishment of the PHC Notes, and thus, it derecognized the PHC Notes in its consolidated balance sheets and recognized a loss of $25.4 million as the difference between the carrying value plus accrued interest of the PHC Notes of $23.2 million and the $48.6 million fair value of the PHC Exchange Warrant as an extinguishment loss in the caption “Exchange related gain, net” that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss. As a result of the PHC Exchange, the Company recognized a total net gain on exchange of the PHC notes of $18.8 million representing the gain on change in the fair value of the PHC Notes conversion feature recognized as an embedded derivative and the loss on extinguishment of the PHC Notes in exchange for the PHC Exchange Warrant.

2025 Notes

In July 2019, the Company issued $82.0 million in aggregate principal amount of senior convertible notes that will mature on January 15, 2025 (the “2025 Notes”), unless earlier repurchased or converted. The 2025 Notes are convertible, at the option of the holders, into shares of the Company’s common stock, at an initial conversion rate of 757.5758 shares per $1,000 principal amount of the 2025 Notes (equivalent to an initial conversion price of approximately $1.32 per share).

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, $24.0 million aggregate principal of the Company’s outstanding 2025 Notes held by Highbridge Capital Management, LLC (“Highbridge”) were settled pursuant to an exchange agreement. Between September 3, 2020 and January 27, 2021, $6.8 million in aggregate principal of the 2025 Notes were converted into 5,152,259 shares of common stock. Accordingly, $3.2 million of allocated deferred issuance costs and debt discounts were recognized as a loss on extinguishment of debt.

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 $30.8 million in aggregate principal amount of the 2025 Notes (the “Exchanged Notes”) for a combination of $7.5 million of cash and newly issued shares of common stock (the “Exchange Shares”). The number of Exchange Shares was determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period commencing on August 11, 2023 and ending August 31, 2023. Based on the volume-weighted average price per share of the common stock during the averaging period, a total of 35.1 million shares of common stock were issued in the Exchanges. The Exchanges were settled on the initial share issuance date of August 14, 2023 and the final settlement date of September 5, 2023.

The Company accounted for the Exchanges as an extinguishment of the Exchanged Notes and the associated embedded derivative and recognized a loss of $4.6 million in the caption “Exchange related gain (loss), net” that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss. The extinguishment loss represents the difference between (i) the carrying value of the Exchanged Notes (inclusive of the fair value of the embedded derivative) and (ii) the sum of $7.5 million cash payment, the fair value of the Exchanged Shares, and transaction costs incurred in the Exchange.

Following the Exchanges, approximately $20.4 million aggregate principal amount of the 2025 Notes remain outstanding. The remaining unamortized debt discount and debt issuance costs are amortized as interest expense over the term of the loan at an effective interest rate of 15.54%. The fair value of the derivative at June 30, 2024 and December 31, 2023 was $0.0 million and $0.1 million, respectively.

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2023 Notes

In the first quarter of 2018, the Company issued $53.0 million in aggregate principal amount of senior convertible notes due February 1, 2023 (the “2023 Notes”). In July 2019, the Company used the net proceeds from the issuance of the 2025 Notes to repurchase $37.0 million aggregate principal amount of the outstanding 2023 Notes. Each $1,000 of principal of the 2023 Notes is initially convertible into 294.1176 shares of the Company’s common stock, which is equivalent to an initial conversion price of approximately $3.40 per share, subject to adjustment upon the occurrence of specified events. Holders may convert at any time prior to February 1, 2023. Holders who convert on or after the date that is six months after the last date of original issuance of the 2023 Notes but prior to February 1, 2021, may also be entitled to receive, under certain circumstances, an interest make-whole payment payable in shares of common stock. If specific corporate events occur prior to the maturity date, the Company will increase the conversion rate pursuant to the make-whole fundamental change provision for a holder who elects to convert their 2023 Notes in connection with such an event in certain circumstances. Additionally, if a fundamental change occurs prior to the maturity date, holders of the 2023 Notes may require the Company to repurchase all or a portion of their 2023 Notes for cash at a repurchase price equal to 100% of the principal amount plus any accrued and unpaid interest.

The Company bifurcated the embedded conversion option, along with the interest make-whole provision and make-whole fundamental change provision, and in January 2018 recorded the embedded features as a debt discount and derivative liability in the Company’s consolidated balance sheets at its initial fair value of $17.3 million. Additionally, the Company incurred transaction costs of $2.2 million. The debt discount and transaction costs are being amortized to interest expense over the term of the 2023 Notes at an effective interest rate of 9.30%. 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 January 31, 2023, the Company repaid the outstanding principal and accrued interest in full. The derivative was unexercised upon maturity and the fair value in the amount of $0.02 million was recognized as an extinguishment gain in the caption “Other income (expense)” in Company’s consolidated statement of operations and comprehensive loss.

The following carrying amounts were outstanding under the Company’s notes payable as of June 30, 2024 and December 31, 2023 (in thousands):


	June 30, 2024
	Principal ($)	Debt (Discount) Premium ($)⁽¹⁾	Issuance Costs ($)	Carrying Amount ($)
2025 Notes	20,399	(1,728)	(29)	18,642
Loan and Security Agreement	35,000	(505)	(293)	34,202

	December 31, 2023
	Principal ($)	Debt (Discount) Premium ($)⁽¹⁾	Issuance Costs ($)	Carrying Amount ($)
2025 Notes	20,399	(3,090)	(52)	17,257
Loan and Security Agreement	25,000	(733)	(329)	23,938

(1)

Includes accretion of end of term fees payable at maturity

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Interest expense related to the notes payable for the six months ended June 30, 2024 and 2023 was as follows (dollars in thousands):


	Six Months Ended June 30, 2024
	Interest Rate	Interest ($)	Debt Discount and Fees ($)⁽¹⁾	Issuance Costs ($)	Total Interest Expense ($)
2025 Notes	5.25%	535	1,362	23	1,920
Loan and Security Agreement	9.90%	1,749	427	37	2,213
Total		2,284	1,789	60	4,133


	Six Months Ended June 30, 2023
	Interest Rate	Interest ($)	Debt Discount and Fees ($)⁽¹⁾	Issuance Costs ($)	Total Interest Expense ($)
2023 Notes	5.25%	69	120	-	189
2025 Notes	5.25%	1,344	3,146	53	4,543
PHC Notes	8.00%	700	1,442	88	2,230
Total		2,113	4,708	141	6,962

(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 June 30, 2024 (in thousands):


2025		20,399
2026		12,996
2027		24,437
Total	$	57,832

13.

Stockholders’ Equity

In November 2021, the Company entered into the 2021 Sales Agreement with Jefferies, 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 $150.0 million through Jefferies as the sales agent in an “at the market” offering. Jefferies received commissions up to 3.0% of the gross proceeds of any common stock sold through Jefferies under the 2021 Sales Agreement. In 2023, the Company received $7.4 million in net proceeds from the sale of 9,944,663 shares of its common stock under the 2021 Sales Agreement. Effective August 7, 2023, the Company and Jefferies mutually agreed to terminate the 2021 Sales Agreement. At the time of termination, approximately $106.6 million remained available for issuance pursuant to the 2021 Sales Agreement.

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 will receive a commission up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares of the Company’s common stock will be offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed by the Company with the Securities and Exchange Commission on August 10, 2023. For the period ending June 30, 2024, the Company received approximately $0.3 million in net proceeds from the sale of 728,291 shares of its common stock under the Equity Distribution Agreement.

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

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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 ten years after the date of grant.

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 3.5% of the total number of shares of its common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by its Board of Directors. As of June 30, 2024, 27,844,978 shares remained available for grant under the Amended and Restated 2015 Plan.

Inducement Plan

On May 30, 2019, the Company adopted the Senseonics Holdings, Inc. Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved 1,800,000 shares of the Company’s common stock for issuance. The only persons eligible to receive grants of awards under the Inducement Plan are individuals who satisfy the standards for 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 June 30, 2024, 317,094 shares remained available for grant under the Inducement Plan.

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 10,000,000 shares of common stock for issuance. Eligible recipients under the plan are non-employees of Senseonics, including employees of our global commercial partner, Ascensia, who assist with the commercialization of our products. An “Award” is any right to receive the Company’s common stock pursuant to the Commercial Equity Plan, consisting of non-statutory options and restricted stock unit awards. As of June 30, 2024, 7,700,000 shares remained available for grant under the Commercial Equity Plan.

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 800,000 shares and automatically increases on January 1 of each year, ending on and including January 1, 2026, by 1.0% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year; provided, however, the Board of Directors may act prior to the first day of any calendar year to provide that there will be no January 1 increase in the share reserve for such calendar year or that the increase in the share reserve for such calendar year will be a lesser number of shares of common stock. As of June 30, 2024, there were 22,729,158 shares of common stock available for issuance under the 2016 ESPP. For the six months ended June 30, 2024, there were purchases of 199,066 shares of common stock pursuant to the 2016 ESPP.

The 2016 ESPP permits participants to purchase shares of the Company’s common stock through payroll deductions of up to 15% of their earnings. Unless otherwise determined by the administrator, the purchase price of the shares will be 85% of the lower of the fair market value of common stock on the first day of an offering or on the date of purchase. Participants may end their participation at any time and deductions not yet used in a purchase are refundable upon employment termination. The Company initiated its first 2016 ESPP offering period on August 1, 2019 and new offering periods occur every six months thereafter, each consisting of two purchase periods of six months in duration ending on or about January 31^st and July 31^st of each year. A participant may only be in one offering at a time. The 2016 ESPP contains an offering reset provision whereby if the fair market value of a share on offering date of an ongoing

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offering is less than or equal to the fair market value of a share on a new offering date, the ongoing offering will terminate immediately after the purchase date and rolls over to the new offering.

The 2016 ESPP is considered compensatory for financial reporting purposes.

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. All awards issued under the 1997 Plan are fully vested. Approximately 823,389 shares of the Company’s common stock underlying options remain outstanding under the 1997 Plan. Upon the effectiveness of the 2015 Plan, the Company no longer grants any awards under the 1997 Plan.

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 June 30, 2024 and December 31, 2023 (in thousands):


	June 30, 2024
	Total		Level 1		Level 2		Level 3
Assets
Money market funds⁽¹⁾	$	33,901	$	33,901		—		—
Commercial paper		11,775		—		11,775		—
Government and agency securities		37,999		37,399		—		—


	December 31, 2023
	Total		Level 1		Level 2		Level 3
Assets
Money market funds⁽¹⁾	$	72,953	$	72,953		—		—
Commercial paper		7,598		—		7,598		—
Corporate debt securities		7,982		—		7,982		—
Government and agency securities		18,167		18,167		—		—
Liabilities
Embedded features of the 2025 Notes	$	102		—		—		102

(1)Classified as cash and cash equivalents due to their short-term maturity

The following table provides a reconciliation of the beginning and ending net balances of items measured at fair value on a recurring that used significant unobservable inputs (Level 3) (in thousands):



	Level 3
	Instruments
December 31, 2023	$	102
Conversion of financial instruments		—
Gain on change in fair value of embedded features of the 2025 Notes		(102)
June 30, 2024	$	—

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The recurring Level 3 fair value measurements of the embedded features of the notes payable and preferred stock, include the following significant unobservable inputs at June 30, 2024:




		2025 Notes
Unobservable Inputs	`	Assumptions
Stock price volatility		45.0	%
Probabilities of conversion provisions		10-90	%
Credit spread		14.3	%

16.

Income Taxes

The Company has not recorded any tax provision or benefit for the six months ended June 30, 2024 or 2023. The Company has provided a valuation allowance for the full amount of its net deferred tax assets since realization of any future benefit from deductible temporary differences, NOL carryforwards and research and development credits is not more-likely-than-not to be realized at June 30, 2024 and December 31, 2023.

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 (see Note 12 for further discussion). Ascensia, through the ownership interests of its parent company, PHC, is a related party. Revenue from Ascensia during the six months ended June 30, 2024 and 2023 was $8.5 million and $7.5 million, respectively. We also purchase certain medical supplies from Ascensia for our clinical trials. We paid Ascensia $0.05 million and $0.3 million during the six months ended June 30, 2024 and 2023, respectively under this arrangement.

The amount due from Ascensia as of June 30, 2024 and December 31, 2023 was $3.1 million and $3.7 million, respectively. The amount due to Ascensia as of June 30, 2024 and December 31, 2023 was $1.2 million and $0.5 million, respectively.

18. 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 June 30, 2024, and events which occurred subsequently but were not recognized in the financial statements. There were no subsequent events that required recognition or disclosure.

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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,” “project,” 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, 2023, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2024. 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 subsidiary.

Overview

We are a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Our implantable CGM (“Eversense”), including 90-day Eversense, Eversense XL and Eversense E3 CGM system versions 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 XL and Eversense E3, as compared to seven to 14 days for non-implantable CGM systems. We affixed the CE mark to the original 90-day Eversense CGM system in June 2016, which marked the first certification for the product to be sold within the European Economic Area (being the European Union plus Norway, Iceland, and Liechtenstein) (“EEA”). Subsequently, we affixed the CE mark to the extended life Eversense XL CGM system in September 2017 to be sold in select markets in Europe and the Middle East. In June 2022, we affixed the CE mark to the extended life Eversense E3 CGM system and Ascensia began commercialization in select markets in Europe during the third quarter of 2022. In June 2018, the FDA, approved the 90-day Eversense CGM system for distribution throughout the United States. In June 2019, we received FDA approval for the non-adjunctive indication (dosing claim) for the 90-day Eversense system. With this approval and the availability of a new app in December 2019, the Eversense system can now be used as a therapeutic CGM in the United States to replace fingerstick blood glucose measurement to make treatment decisions, including insulin dosing. In February 2022, the 180-day extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States in the second quarter of 2022.

Our net revenues are derived from sales of the Eversense system which is sold in two separate kits: the disposable Eversense Sensor Pack which includes the sensor, insertion tool, and adhesive patches, and the durable Eversense Smart Transmitter Pack which includes the transmitter and charger.

We primarily sell directly to our network of distributors and strategic fulfillment partners, who provide the Eversense system to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement. Sales of the Eversense system are widely dependent on the ability of patients to obtain coverage and

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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 CGM system 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 CGM 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 global 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. The Calendar Year 2024 Medicare Physician Fee Schedule continues to include the three CPT© Category III codes. 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. The majority of Medicare administrative contractor (“MAC”) expansion is effective or becoming effective on August 11, 2024 with the final MAC’s expected to become effective in the near future.

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 Pivotal study for the Eversense 365-day System. The ENHANCE pivotal study for the Eversense 365-day system 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.

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 CGM systems, including 90-day Eversense, Eversense XL, Eversense E3 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 Eversense 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 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 in the United States for 90-day use. On June 21, 2018, we received PMA approval from the FDA for the Eversense system. In July 2018, we began distributing the 90-day Eversense 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 sensor.

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In December 2018, we initiated the PROMISE pivotal clinical trial to evaluate the safety and accuracy of Eversense 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-day product 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 the Eversense CGM System to six months was submitted to the FDA. In February 2022, the extended life Eversense E3 CGM system was approved by the FDA.

In June 2019, we received FDA approval for the non-adjunctive indication (dosing claim) for the Eversense system and launched with an updated app in December 2019. With this approval, the Eversense system 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 the Eversense 365 System.

In April 2020, we announced that we received an extension to our CE Certificate of Conformity in the EEA such that the Eversense XL is no longer contraindicated for MRI, which means the sensor does not need to be removed from under the skin during MRI scanning. We had previously obtained this indication for Eversense 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 collaboration and commercialization agreement with Ascensia (the “Commercialization Agreement”) pursuant to which we granted Ascensia the exclusive right to distribute our 90-day Eversense CGM system and our 180-day Eversense E3 CGM system worldwide, with the following initial exceptions: (i) until January 31, 2021, the territory did not include countries covered by our then existing distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH (together “Roche”), which included Europe, Middle East and Asia, excluding Scandinavia and Israel, and 17 additional countries, including Brazil, Russia, India and China, as well as select markets in the Asia Pacific and Latin American regions; (ii) until September 13, 2021, the territory did not include countries covered by our then current distribution agreement with Rubin Medical, which included Sweden, Norway and Denmark; and (iii) until May 31, 2022, the territory did not include Israel. Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the 90-day Eversense product on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for the 90-day Eversense product during the second quarter of 2021.

In February 2022, we received approval from the FDA for the Eversense E3 CGM System. 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 the Eversense E3 system using the SBA technology. In March 2022, we extended the ongoing ENHANCE clinical study to evaluate the safety and accuracy of the Eversense 365 System 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 devise enrollment (“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 was authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future. Based on the analysis of the ENHANCE Pivotal study data, the decision was made to advance to the next generation sensor platform as the underlying technology used in the 365-day and future products. In

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May 2024, this data supported an FDA 510(k) submission for a new product with a 365-day duration and once per week calibration.

In April 2024 and July 2024, Eon Care Services, LLC and Eon Management Services, LLC, (collectively “Eon Care”) were formed as wholly owned subsidiaries of Senseonics, Incorporated. Eon Care has been established to support patient access to the Eversense system by providing convenient Eversense insertion and training services. The Company expects established CPT codes associated with Eversense insertions to enable a self-sustaining economic model for this initiative in the future. Eon Care operations are planned to commence by the end of 2024.

In July 2024, we began first-in-human testing for the Gemini system. 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 a future IDE submission.

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 European Economic Area (“EEA”). The 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.

We previously held a distribution agreement with Roche and granted Roche the exclusive right to market, sell and distribute Eversense in certain territories within EMEA and other countries outside of the United States. The distribution rights under the agreement expired January 31, 2021.

In June 2022, we affixed the CE mark to the extended life Eversense E3 CGM system, and Ascensia began commercialization in European markets during the second half of 2022.

Financial Overview

Revenue

We 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 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”). We are generally paid for our sales directly to the Customers, regardless of whether or not the Customers resell the products to health care providers and patients.

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 are typically satisfied upon transfer of control of the product. Additionally, a portion of revenue is recognized through our consignment program whereas small quantities of inventory are maintained securely at various health care provider locations within the United States. Under this model, the Company does not recognize revenue upon shipment of product. Rather, revenue is recognized when the product is consumed by a patient.

Customer contracts do not include the right to return unless there is a product issue, in which case we may provide a 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.

In addition, we sell small quantities of our products directly to healthcare provider locations within the United States. In these direct sales, inventory is purchased on consignment to ensure availability when a patient is identified. No

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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. Consignment sales represented approximately 14.7% of our net sales for the three months ended June 30, 2024.

Our contracts may contain some form of variable consideration such as prompt-pay discounts, tier-volume price discounts and for the Ascensia commercial 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.

Concentration of Revenue and Customers

For the three months ended June 30, 2024 and 2023, the Company derived 84% and 89%, respectively, of its total revenue from one customer, Ascensia. For the six months ended June 30, 2024 and 2023, the Company derived 86% and 91%, respectively, of its total revenue from one customer, Ascensia. Revenues for these corresponding periods represent sales of sensors, transmitters and miscellaneous Eversense system components.

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 six months ended June 30, 2024 and 2023:


	Three Months Ended				Six Months Ended
	June 30, 2024				June 30, 2024
			%				%
(Dollars in thousands)	Amount		of Total		Amount		of Total
Revenue, net:
United States	$	3,030	62.3	%	$	6,706	67.7	%
Outside of the United States		1,835	37.7			3,206	32.3
Total	$	4,865	100.0	%	$	9,912	100.0	%


	Three Months Ended				Six Months Ended
	June 30, 2023				June 30, 2023
			%				%
(Dollars in thousands)	Amount		of Total		Amount		of Total
Revenue, net:
United States	$	1,793	43.5	%	$	3,955	47.9	%
Outside of the United States		2,333	56.5			4,308	52.1
Total	$	4,126	100.0	%	$	8,263	100.0	%

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Results of Operations for the Three Months Ended June 30, 2024 and 2023


	Three Months Ended
	June 30,				Period-to-
	2024		2023		Period Change

	(in thousands)					(in thousands)
Revenue, net	$	778	$	437	$	341
Revenue, net - related parties		4,087		3,689		398
Total revenue		4,865		4,126		739
Cost of sales		4,567		3,709		858
Gross profit		298		417		(119)

Expenses:
Research and development expenses		10,800		12,830		(2,030)
Selling, general and administrative expenses		8,991		7,455		1,536
Operating loss		(19,493)		(19,868)		375
Other (expense) income, net:
Interest income		1,190		1,311		(121)
Interest expense		(2,085)		(2,310)		225
Gain on change in fair value of derivatives		102		289		(187)
Other income (expense)		(1)		155		(156)
Total Other (expense) income, net		(794)		(555)		(239)
Net Loss	$	(20,287)	$	(20,423)	$	136

Total revenue

Our total revenue increased to $4.9 million for the three months ended June 30, 2024, compared to $4.1 million for the three months ended June 30, 2023, an increase of $0.8 million. This increase was primarily the result of increased commercial activities driving new patients partially offset by slightly lower sales outside of the United States during 2024.

Cost of sales and gross profit

Our cost of sales increased to $4.6 million for the three months ended June 30, 2024, compared to $3.7 million for the three months ended June 30, 2023 and our gross profit decreased to $0.3 million for the three months ended June 30, 2024, compared to $0.4 million for the three months ended June 30, 2023. Gross profit as a percentage of revenue, or gross margin, was 6.1% and 10.1% for the three months ended June 30, 2024, and June 30, 2023, respectively. The decrease in gross margin was primarily due to increases in fixed manufacturing costs.

Research and development expenses

Research and development expenses were $10.8 million for the three months ended June 30, 2024, compared to $12.8 million for the three months ended June 30, 2023, a decrease of $2.0 million. The decrease was mainly driven by a $4.0 million reduction of clinical studies spend due to the completion of 365-day product trials and a $0.1 million reduction in consultants and other support services. These decreases were partially offset by an increase in personnel costs of $1.8 million due to an increase in headcount to support our long-term product development projects and a $0.3 million increase in equipment depreciation.

Selling, general and administrative expenses

Sales, general and administrative expenses were $9.0 million for the three months ended June 30, 2024, compared to $7.5 million for the three months ended June 30, 2023, an increase of $1.5 million. The increase was primarily the result of $0.7 million increase in personnel costs mainly due to stock-based compensation and $0.6 million

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increase in legal and patent costs to expand commercial initiatives such as Eon Care Services and hospital system Eversense integrations.

Total other income (expense), net

Total other expense, net was ($0.8) million for the three months ended June 30, 2024, compared to other expense, net of ($0.6) million for the three months ended June 30, 2023, a decrease in other income of $0.2 million. The change was primarily due to a $0.4 million decrease in gain on fair value adjustment of note derivatives and associated amortization partially offset by a $0.2 million decrease in interest income (expense), net due to the Loan and Security Agreement and market interest rate increases.

Results of Operations for the Six Months Ended June 30, 2024 and 2023


	Six Months Ended
	June 30,				Period-to-
	2024		2023		Period Change

	(in thousands)
Revenue, net	$	1,367	$	750	$	617
Revenue, net - related parties		8,545		7,513		1,032
Total revenue		9,912		8,263		1,649
Cost of sales		9,279		7,433		1,846
Gross profit		633		830		(197)

Expenses:
Research and development expenses		21,238		25,235		(3,997)
Selling, general and administrative expenses		17,119		15,173		1,946
Operating loss		(37,724)		(39,578)		1,854
Other income (expense), net:
Interest income		2,574		2,420		154
Exchange related gain, net		—		18,776		(18,776)
Interest expense		(4,133)		(6,962)		2,829
Gain on change in fair value of derivatives		102		6,067		(5,965)
Other income		17		178		(161)
Total other (expense) income, net		(1,440)		20,479		(21,919)
Net Loss	$	(39,164)	$	(19,099)	$	(20,065)

Total revenue

Our total revenue increased to $9.9 million for the six months ended June 30, 2024, compared to $8.3 million for the six months ended June 30, 2023, an increase of $1.6 million. This increase was primarily the result of increased commercial activities driving new patients partially offset by slightly lower sales outside of the United States during 2024.

Cost of sales and gross profit

Our cost of sales were $9.3 million for the six months ended June 30, 2024, compared to $7.4 million for the six months ended June 30, 2023, an increase of $1.9 million. Our gross profit decreased to $0.6 million for the six months ended June 30, 2024, compared to $0.8 million for the six months ended June 30, 2023. Gross profit as a percentage of revenue, or gross margin, was 6.4% and 10.0% for the six months ended June 30, 2024, and June 30, 2023, respectively.

The decrease in gross margin was primarily due to higher fixed manufacturing costs. In addition, the gross margin decrease is also driven by an increase to the revenue share percentage due to Ascensia.

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Research and development expenses

Research and development expenses were $21.2 million for the six months ended June 30, 2024, compared to $25.2 million for the six months ended June 30, 2023, a decrease of $4.0 million. The decrease was mainly driven by a $6.8 million reduction of clinical studies spend due to the wind down of 365-day product trials. This decrease was partially offset by an increase in personnel costs of $2.5 million to support our long-term product development projects, $0.2 million increase in equipment depreciation and $0.1 million for consultants and other support services.

Selling, general and administrative expenses

Sales, general and administrative expenses were $17.1 million for the six months ended June 30, 2024, compared to $15.2 million for the six months ended June 30, 2023, an increase of $1.9 million. The increase was primarily due to a $0.9 million increase in personnel costs from stock-based compensation, commissions, and recruiting costs and $1.1 million increase in legal expenses primarily to expand commercial initiatives for Eon Care Services and the hospital system Eversense integrations. These increases were partially offset by lower insurance costs of $0.1 million.

Total other income (expense), net

Total other expense, net was ($1.4) million for the six months ended June 30, 2024, compared to other income, net of $20.5 million for the six months ended June 30, 2023, a decrease in other income of $21.9 million. The change was primarily due to a $50.2 million reduction in gains on the fair value of derivatives as the result of debt settlements and the decrease in our stock prices since the second quarter of 2023 along with a $1.1 million reduction in amortization due to these settlements, and a $0.1 million decrease in other income. The decreases were partially offset by a $25.4 million reduction in the loss on exchange of debt and a $4.1 million increase in interest income (expense), net due to the settlement of notes.

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) income of ($60.4) million and $142.1 million for the years ended December 31, 2023 and 2022, respectively. For the six months ending June 30, 2024, the Company had gross profit of $0.6 million and an accumulated deficit of $908.4 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 June 30, 2024, the Company had unrestricted cash, cash equivalents, and marketable securities of $84.6 million.

On September 8, 2023 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with the several financial institutions or entities party thereto (collectively, the “Lenders") and Hercules Capital, Inc., a Maryland corporation (“Hercules”), pursuant to which the Lenders have agreed to make available to the Company 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) two additional tranches of term loans in the amounts of up to $10.0 million (the “Tranche 2 Loan”) and $15.0 million (the “Tranche 3 Loan”), respectively, which will become available to the Company upon the Company’s satisfaction of certain terms and conditions set forth in the Loan and Security Agreement. In December 2023, we met the terms and conditions to draw on the Tranche 2 Loan and the loan was funded on January 2, 2024 in an amount of $10.0 million. The loans under the Loan and Security Agreement mature on September 1, 2027 (the “Maturity Date”).

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5.25% Convertible Senior Notes due 2025 (the “2025 Notes”). Under the terms of the Exchange Agreements, the Noteholders agreed to exchange with the Company (the “Exchanges”) up to $30.8 million in aggregate principal amount of the Company’s outstanding 2025 Notes (the “Exchanged Notes”) for a combination of $7.5 million of cash and newly issued shares of common stock (the “Exchange Shares”). The number of Exchange Shares was determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period commencing on August 11, 2023 and ending August 31, 2023. Based on the volume-weighted average price per share of the common stock during the averaging period, a total of 35.1 million shares of common stock were issued in the Exchanges. The Exchanges were settled on the initial share issuance date of August 14, 2023 and the final settlement date of September 5, 2023.

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, which represented the remaining capacity under our then-existing at

the market program with Jefferies LLC, as described below. GS will receive a commission up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares will be offered and sold pursuant to an effective shelf registration statement on Form S-3 (the “Registration Statement”), which was originally filed with the Securities and Exchange Commission (the “Commission”) on August 10, 2023. As of June 30, 2024, the Company received approximately $0.3 million in net proceeds from the sale of 728,291 shares under the Equity Distribution Agreement.

On August 9, 2020, the Company entered into a financing agreement with PHC, pursuant to which the Company issued $35.0 million in aggregate principal amount of Senior Secured Convertible Notes due on October 31, 2024 (the “PHC Notes”), to PHC. The Company also issued 2,941,176 shares of common stock to PHC as a financing fee. The Company also has the option to sell and issue PHC up to $15.0 million of convertible preferred stock on or before December 31, 2022, contingent upon obtaining FDA approval for the 180-day Eversense product for marketing in the United States before such date. The Company successfully obtained FDA approval in February 2022 and the option was not exercised.

On March 13, 2023, the Company entered into an Exchange Agreement with PHC, pursuant to which PHC agreed to exchange its $35.0 million aggregate principal amount of the PHC Notes, including all accrued and unpaid interest thereon, for the PHC Exchange Warrant to purchase up to 68,525,311 PHC Exchange Warrant Shares. The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per PHC Exchange Warrant Share. The number of PHC Exchange Warrant Shares represents the number of shares of common stock previously issuable upon conversion of the PHC Notes, in accordance with the original terms of the notes, including a number of shares in respect of accrued and unpaid interest through the closing date, plus additional shares with a value of $675,000 reflecting a portion of the future interest payments forgone by PHC. On March 31, 2023 (6:00 am Japan Standard Time on April 1, 2023), the PHC Exchange was consummated, and the Company issued the PHC Exchange Warrant in consideration for the cancellation of the PHC Notes.

On March 13, 2023, the Company entered into a Securities Purchase Agreement with PHC, pursuant to which the Company issued and sold to PHC in a private placement a Purchase Warrant to purchase an aggregate of 15,425,750 Purchase Warrant Shares. The purchase price of the Purchase Warrant was approximately $0.97 per Purchase Warrant Share, representing the undiscounted, trailing 10-day volume weighted average price of the Company’s common stock through March 10, 2023. The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per

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Purchase Warrant Share. The issuance of the Purchase Warrants enabled PHC to maintain, as of the closing of the transaction, a 15% beneficial ownership for purposes of the Investor Rights Agreement, dated August 9, 2020, between the Company and PHC. The Private Placement closed on March 13, 2023 and the Company received aggregate gross proceeds of $15.0 million, before deducting private placement expenses payable by the Company.

We do not expect our existing cash and cash equivalents will be sufficient to fund our operations and maintain cash and performance requirements to comply with debt covenants under its Loan and Security Agreement through the second quarter of 2025. 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, as further described below under “Funding Requirements and Outlook”.

Indebtedness

Loan and Security Agreement

On September 8, 2023, Company entered into the Loan and Security Agreement with the Lenders and Hercules, pursuant to which the Lenders have agreed to make available to the Company the Term Loan Facility, consisting of (i) an initial Tranche 1 Loan, which was 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 Tranche 3 Loan, which will become available to the Company upon the Company’s satisfaction of certain terms and conditions set forth in the Loan and Security Agreement. The loans under the Loan and Security Agreement mature on the Maturity Date.

Convertible Notes

The following table summarizes our outstanding convertible notes at June 30, 2024:

Aggregate

Initial Conversion

Conversion Price

Convertible

Issuance

Principal

Maturity

Rate per $1,000

per Share of

Note

Date

Coupon

(in millions)

Date

Principal Amount

Common Stock

2025 Notes

July 1, 2019

5.25%

20.4

January 15, 2025

757.5758

1.32

As described above, on August 10, 2023, we executed a series of exchange agreements with certain holders of the 2025 Notes to exchange an aggregate principal amount of up to $30.8 million of 2025 Notes for a combination of cash and newly issued shares of common stock. For additional information on the 2025 Notes, see Note 12—Notes Payable, Preferred Stock and Stock Purchase Warrants in the accompanying unaudited consolidated financial statements.

Funding Requirements and Outlook

Our ability to grow revenues and achieve profitability depends on the successful commercialization and adoption of our Eversense CGM systems by diabetes patients and healthcare providers, along with future product development, regulatory approvals, and post-approval requirements. These activities and continued development of the Eversense 365-day product and other future products will require significant uses of working capital through 2024 and beyond. As of June 30, 2024, the Company had unrestricted cash, cash equivalents and marketable securities of $84.6 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,

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existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under its 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.

Cash Flows

The following is a summary of cash flows for each of the periods set forth below (in thousands).


	Six Months Ended
	June 30,
	2024		2023
Net cash used in operating activities	$	(31,404)	$	(37,832)
Net cash provided by (used in) investing activities		(18,150)		25,871
Net cash provided by financing activities		9,016		4,719
Net decrease in cash, cash equivalents and restricted cash	$	(40,538)	$	(7,242)

Net cash used in operating activities

Net cash used in operating activities was $31.4 million for the six months ended June 30, 2024, and consisted of a net loss of $39.2 million, partially offset by a net change in operating assets and liabilities of $0.7 million (most notably increases in accounts payable of $3.3 million offset by $1.5 million in inventory and $1.6 million in deposits and other assets) $4.7 million of stock-based compensation and $2.4 million related to depreciation/amortization and other non-cash items.

Net cash used in operating activities was $37.8 million for the six months ended June 30, 2023, and consisted of a net loss of $19.1 million, $18.8 million net gain on the exchange of the PHC Notes, a $6.1 million gain on change in the fair value of the 2025 Notes embedded derivative, a net change in operating assets and liabilities of $2.4 million (most notably increases in accounts receivable of $1.2 million and inventory of $1.8 million), partially offset by $3.9 million related to depreciation/amortization and other non-cash items and $4.7 million of stock-based compensation.

Net cash provided by (used in) investing activities

Net cash used in investing activities was $18.2 million for the six months ended June 30, 2024 and consisted of $33.9 million in proceeds from the sale and maturity of marketable securities, offset by $49.7 million in purchase of marketable securities and $2.4 million of capital expenditures.

Net cash provided by investing activities was $25.9 million for the six months ended June 30, 2023, and primarily consisted of $87.7 million in proceeds from the sale and maturity of marketable securities partially offset by $61.8 million in purchase of marketable securities.

Net cash provided by financing activities

Net cash provided by financing activities was $9.0 million for the six months ended June 30, 2024, and primarily consisted of $10.0 million in proceeds from the Tranche 2 Loan, net offset by $1.0 million from taxes paid related to net share settlement of equity awards.

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Net cash provided by financing activities was $4.7 million for the six months ended June 30, 2023, and primarily consisted of $7.4 million in proceeds from issuance of common stock and $14.7 million in proceeds from issuance of the PHC Purchase Warrant, partially offset by $15.7 million for the repayment of the 2023 Notes, $0.1 million for issuance of stock options, and $1.6 million related to the settlement of equity awards.

Contractual Obligations

As of June 30, 2024, there were no material changes in our contractual obligations and commitments from those disclosed in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K filed with the SEC on March 1, 2024.

ITEM 3: Quantitative and Qualitative Disclosures About Market Risk

Under SEC rules and regulations, because we are considered to be a “smaller reporting company”, we are not required to provide the information required by this item in this Quarterly Report on Form 10-Q.

ITEM 4: Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the assistance of our chief executive officer, who is our principal executive officer, and our chief financial officer, who is our principal financial officer, has reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of June 30, 2024. 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 June 30, 2024, 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 June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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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 February 2021, the Company received notice and accepted service of a civil complaint that had been filed in the Western District of Texas and styled Carew ex rel. United States v. Senseonics, Inc., No. SA20CA0657DAE. The complaint was filed by a relator under seal in May 2020 pursuant to the qui tam provisions in the federal False Claims Act. Prior to the unsealing of the complaint, the government declined to intervene in the case. The case, therefore, is being pursued only by the relator and his counsel. The complaint alleges the Company’s marketing practices with physicians for its product, Eversense CGM system, violated the False Claims Act, 31 U.S.C. § 3729 and the Texas Medicaid Fraud Prevention Law, Tex. Hum Res. Code § 36.002. The court granted the Company’s motion to dismiss the complaint on March 31, 2022 but permitted the plaintiff to file an amended complaint. The court dismissed the amended complaint and entered judgment in favor of Senseonics Holdings, Inc. on March 30, 2023. The relator filed a notice of appeal to the United States Court of Appeals for the Fifth Circuit on April 28, 2023. The appeal was fully briefed, and the case was argued before the Fifth Circuit on February 6, 2024. On February 28, 2024 the Fifth Circuit issued a Per Curiam order affirming the District Court’s decision that Carew failed to state a claim. This order affirms the District Court’s dismissal of the plaintiff’s lawsuit.

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 Company’s response to the complaint is due on September 3, 2024. The Company is reviewing the allegations further and 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.

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.

The medical device industry is characterized by patent litigation, and we could become subject to litigation that could be costly, result in the diversion of management's time and efforts, stop our development and commercialization measures, harm our reputation or require us to pay damages.

Our success will depend in part on not infringing the patents or violating the other proprietary rights of third parties. Significant litigation regarding patent rights exists in our industry. Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make and sell our products. The large number of patents, the rapid rate of new patent issuances, and the complexities of the technology involved increase the risk of patent litigation.

The medical device industry in general, and the glucose testing sector of this industry in particular, are characterized by the existence of a large number of patents and frequent litigation based on assertions of patent infringement. We are aware of numerous patents issued to third parties that may relate to the technology used in our

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business, including the design and manufacture of CGM sensors and CGM systems, as well as methods for continuous glucose monitoring. Each of these patents contains multiple claims, any one of which may be independently asserted against us. The owners of these patents may assert that the manufacture, use, sale or offer for sale of our CGM sensors or CGM systems infringes one or more claims of their patents. For example, as noted above, in May 2024, we were served with a complaint by Cellspin Soft, Inc., a non-practicing entity, filed against us in the United States District Court for the Eastern District of Texas, alleging that we infringe certain patents owned by it and seeking unspecified damages. We note that the validity of all three patents-in-suit is currently being challenged in Inter Partes Review proceedings at the U.S. Patent and Trademark office. We are further reviewing the allegations, and intend to vigorously defend the lawsuit, however, the outcome of any litigation, such as this, is inherently unpredictable.

Furthermore, there may be additional patents issued to third parties of which we are presently unaware that may relate to aspects of our technology that such third parties could assert against us and materially and adversely affect our business. In addition, because patent applications can take many years to issue, there may be patent applications that are currently pending and unknown to us, which may later result in issued patents that third parties could assert against us and harm our business.

In preparation for commercializing our Eversense products, we perform ongoing analyses, the purpose of which is to review and assess publicly available information to determine whether third parties hold any valid patent rights that a well-informed court would more likely than not find that we would infringe by commercializing our products, understanding that there are risks and uncertainties associated with any litigation and no predictions or assurances can be made regarding the outcome of any such litigation. Although our review and analysis are not complete and subject to the express limitations in the preceding sentence, we are not aware of any such valid patent rights. Moreover, we have not previously performed an exhaustive review of this type, and we cannot be certain that it will not result in our locating patent rights relating to our products of which we were not previously aware.

In the future, we could receive communications from other parties alleging our infringement of their intellectual property rights. Any intellectual property litigation, including the pending litigation described above, could force us to do one or more of the following:

●

stop selling our products or using technology that contains the allegedly infringing intellectual property;

●

incur significant legal expenses;

●

pay substantial damages to the party whose intellectual property rights we are allegedly infringing;

●

redesign those products that contain the allegedly infringing intellectual property; or

●

attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on

reasonable terms or at all, and if available, may be non-exclusive, thereby giving our competitors access to the

same technology.

Patent litigation can involve complex factual and legal questions, and its outcome is uncertain. Any litigation or claim against us, even those without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our core business, stop our development and commercialization measures and harm our reputation. Further, as the number of participants in the diabetes market increases, the possibility of intellectual property infringement claims against us increases.

There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

Our unaudited condensed consolidated financial statements as of June 30, 2024 have been prepared assuming the Company will continue as a going concern for the next twelve months. Our management concluded that our recurring losses from operations, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, and minimum cash and satisfaction of performance milestones to comply with debt covenants under its Loan and Security Agreement raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements included in this Quarterly Report on Form 10-Q. As of June 30, 2024,

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we had unrestricted cash, cash equivalents and marketable securities of $84.6 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 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. Although management has been successful in raising capital in the past, there can be no assurance that we will be successful 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 included in this Quarterly Report on Form 10-Q and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds

Not applicable.

ITEM 3: Defaults Upon Senior Securities

Not applicable.

ITEM 4: Mine Safety Disclosures

Not applicable.

ITEM 5: Other Information

During the fiscal quarter ended June 30, 2024, none of our officers or directors, as defined in Rule 16a-1(f), adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” as those terms are defined in Item 408 of Regulation S-K.

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ITEM 6: Exhibits

The exhibits listed on the Exhibit Index hereto are filed or incorporated by reference (as stated therein) as part of this Quarterly Report on Form 10-Q.


Exhibit No.		Document

3.1		Amended and Restated Certificate of Incorporation of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on March 23, 2016).

3.2		Amended and Restated Bylaws of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on March 23, 2016).

3.3		Certificate of Amendment to Amended and Restated Certificate of Incorporation of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.3 to the Registrant’s Quarterly Report on Form 10-Q for the Quarter ended June 30, 2018 (File No. 001-37717), filed with the Commission on August 8, 2018).

3.4		Certificate of Amendment to Amended and Restated Certificate of Incorporation of Senseonics Holdings, Inc. (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on May 22, 2024).

3.5		Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717), filed with the Commission on August 18, 2020).

3.6		Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37717) filed on October 26, 2020).

3.7		Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.5 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37717) filed with the Commission on November 8, 2022).

3.8		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).

10.1#*		Third Amendment to Collaboration and Commercialization Agreement, by and between the Subsidiary and Ascensia Diabetes Care Holdings AG, dated as of April 1, 2024.

31.1*		Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act.

31.2*		Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act.

32.1**		Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act.

101.INS*		Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document)

101.SCH*		Inline XBRL Taxonomy Extension Schema Document

101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document

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.

#	Certain portions of this exhibit, indicated by asterisks, have been omitted because they are not material and are the type that the registrant treats as private and confidential.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	SENSEONICS HOLDINGS, INC.


Date: August 8, 2024	By:	/s/Rick Sullivan
		Rick Sullivan
		Chief Financial Officer
		(Principal Financial Officer)

CERTAIN PORTIONS OF THIS EXHIBIT (INDICATED BY ***) HAVE BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10) OF REGULATION S-K BECAUSE THEY ARE BOTH NOT MATERIAL AND ARE THE TYPE THAT THE COMPANY TREATS AS PRIVATE AND CONFIDENTIAL.

EXHIBIT 10.1

THIRD AMENDMENT TO COLLABORATION AND COMMERCIALIZATION AGREEMENT

This Third Amendment (the “Third Amendment”) to the Collaboration and Commercialization Agreement is entered into by and between Senseonics, Incorporated (“Senseonics”) and Ascensia Diabetes Care Holdings AG (“Ascensia”) (each of Senseonics and Ascensia, a “Party”, and together, the “Parties”) and is effective as of April 1^st, 2024 (the “Third Amendment Effective Date”).

WHEREAS, the Parties have entered into that certain Collaboration and Commercialization Agreement dated as of August 9, 2020, as subsequently amended and supplemented (the “Agreement”);

WHEREAS, the Parties entered into the Second Amendment to the Agreement, which established certain terms and required the good faith renegotiation of certain matters under the Second Amendment; and

WHEREAS, the Parties desire to further amend the Agreement in accordance with Section 9.3 thereof in order to reflect the good faith negotiations covering an updated transfer price, binding forecasting period, warranty provisions, and the launch of the 365-day Product and certain other terms and conditions as hereinafter set forth;

NOW THEREFORE, in consideration of the premises and mutual covenants contained in this Third Amendment, the Parties agree as follows:

Amendment 2. Amendment 2 to the Agreement shall be no longer valid and applicable, and shall be replaced in its entirety by this Amendment 3 as of the Third Amendment Effective Date, except that obligations and liabilities that arose pursuant to Amendment 2 during the period prior to the Third Amendment Effective Date shall continue to exist under the terms of Amendment 2, including any True Up calculations and warranty calculations arising prior to but to be settled on or following the Third Amendment Effective Date. Binding Commitments from before the Third Amendment Effective Date are of no further force or effect, and are replaced in their entirety with the terms of this Amendment 3, as applied to the [***].

Product Warranty. Exhibit E to the Agreement will be deleted and replaced in its entirety by the Exhibit E attached to this Third Amendment. The reference to “warranty claims (as allowed by Exhibit E)” in Section 4.2 of the Agreement shall be deleted. For the avoidance of doubt, there shall be no adjustment to the amounts owed to Senseonics under Section 4.2 for any warranty claims as all warranty units will be included in Section 4.2 True Up Amount.

Transfer Pricing. The transfer price is the price that Ascensia’s Purchase Order will reflect

for the currently-marketed 180-day E3 Product (the “180-day Product”) and the 365-Product expected to be approved during 2024 (the “365-day Product”) to be paid to Senseonics

(“Transfer Price”).

(i)The Transfer Price of the 180-day Product in both the United States and outside the United States on a quarterly basis for sales from Senseonics to Ascensia will be set at

[***] unless otherwise formally agreed by the Joint Alliance Committee for special situations.

(ii)The Transfer Price of the 365-day Product in both the United States and outside the United States on a quarterly basis for sales from Senseonics to Ascensia will be set at

[***] unless otherwise formally agreed by the Joint Alliance Committee for special situations.

Ascensia will provide monthly reports to Senseonics with updates on the average monthly in- market selling prices, net of replacement sensors of the 180-day Product and 365- day Product in [***], and a subtotal for all other relevant markets. If an additional market becomes substantial to results, the Parties will in good faith add monthly reporting on such market.

Minimum Annual Price and Permitted Access Programs. In accordance with the Agreement:

(i)Within [***], the Parties shall establish a Minimum Annual Price of the 365-day Product prior to the launch of the 365-day Product within each such market based on the factors, processes and terms set out in Section 2.4(c) of the Agreement.

(ii)The Parties will discuss in good faith the terms of and controls on any Permitted Access Programs for the 365-day Product (“PASS Program”) prior to the Product Availability Date of the 365-day Product, with the understanding that any approved PASS Program would be designed to support commercially insured patients being able to access the 365-day Product after receipt of an on-label prescription and would be established with controls that limit the utilization of PASS. Following any agreement on such controls, the Parties will agree in good faith on the administration of the PASS Program before any implementation, including such matters as controls, limits, monthly utilization and finance reporting. The Parties may also agree in good faith on similar administration matters of compliant rebate programs with distribution channel partners before any implementation. Based on such discussions and understandings, the Parties will either clearly document approval by the JAC such terms regarding any Permitted Access Program or document such changes in a written Agreement. For the avoidance of doubt, this Amendment does not change any requirement under Section 4.1.1 of the Agreement that requires agreement of the Parties to make an adjustment in the Cap for a Permitted Access Program before more than [***] attributable to Permitted Access

Programs can be deducted from gross sales to calculate Net Sales.

(iii)The Parties also agree that, for the calculation of Net Sales of the 180-day Product in the U.S., for sales from the Third Amendment Effective Date until such time as DME- reimbursed Product Sales in the U.S. are converted to 365-day Product (“Conversion”), the cap for Permitted Access Program charges in Section 4.1.1 of the Agreement (the “Cap”) shall be suspended. This suspension does not apply for the 365-day Product or Products sold outside the U.S. Further, in no case shall the calculation of Net Sales for the 180-day Product be lower than [***]. This limitation does not apply to the 365-day Product. The [***] amounts set forth in Paragraph 3 (i) above are the [***] that will be paid by Ascensia to Senseonics for the 180-day Product and will not be further reduced by any revenue share adjustments, the True-Up, or other amounts.

(iv)If the quarterly Transfer Price for the 365-day Product exceeds the [***] as determined at the quarterly True-Up, with such Revenue Share calculated subject to the terms agreed in accordance with Section 4.1.1 of the Agreement (by the JAC or otherwise) relating to the Permitted Access Program, and pursuant to the provisions of Section 4.2 of the Agreement, then Senseonics will pay Ascensia [***], provided that any such payment remains subject to the Minimum Annual Price provisions of Section 2.4(c) of the Agreement. Notwithstanding Section 10 of this Amendment 3, Section 2.4(c) of the Agreement shall in all cases govern the final calculation of True-Up Amounts.

True-up Mechanics. The Parties agree that for the calculation of the True-Up Amounts pursuant to Section 4.2 of the Agreement, (i) they shall use an agreed upon blended revenue share percentage based upon the estimated blended revenue share percentage resulting from the forecasted revenue for the year and (ii) in the final True-Up Statement for the year shall adjust to account for the difference between the estimated revenue share used for these estimated periods and the final revenue share calculated based on actual revenues for that year.

Forecast and Product Transition. In addition to section 2.3 (b) of the Agreement, the following shall apply as of the Third Amendment Effective Date. For the U.S. portion of each Forecast, Ascensia shall provide Senseonics with a base forecast that designates the expected Product demand in the U.S. irrespective of which duration product is available (the “Base Forecast”), and includes detail specifying which Products are for Global Pay patients (including CMS-reimbursed patients and commercially-insured global payment patients), commercially insured DME-reimbursed patients, and pharmacy channel patients. The Base Forecast may be satisfied with either 180-day Product and /or 365-day Product (“Base Forecast’), based on the Parties’ agreed launch date of the 365-day Product in the U.S. and Medicare reimbursement status, as further contemplated below. Ascensia will also provide Senseonics with an incremental forecast for the 365-day Product (“Incremental Forecast”) which shall designate the expected additional product demand above the Base Forecast in the event the 365-day Product is available, in order to secure additional 365-day Product volume. For the Incremental Forecast, [***] lead time is required for Senseonics to commit to shipment, provided, however Senseonics will make commercially reasonable efforts to accommodate lead time less than [***]. Ascensia’s commitment to purchase the 365-

day Product in the Incremental Forecast shall be governed by the Binding Commitment provisions set out in Section 8 of this Third Amendment, subject to the further provisions in this Section 6. The timing of the Binding Commitment for the Incremental Forecast starts with the Product Availability Date (which for this purpose cannot be [***] without Ascensia’s consent) and Ascensia has no obligation to purchase Product from the Incremental Forecast before such date. By means of an example, if the Product Availability Date is targeted to be [***]. If the launch occurs later than [***], the committed Incremental Forecast binding volumes will slide back correspondingly month-for-month based on the revised launch date, so that with a one month delay (if not superseded by the [***]. Any expiration of the 365-day Product and all its related materials (i.e. Product not meeting the dating requirements to ship to Ascensia) that is due to the Product Availability Date of the 365-day Product being pushed out shall be solely and entirely for Senseonics’ risk and account. Excess and Obsolete charges for 180-day Finished Product from the transition of the 180-day Product to 365-day Product (i.e. Product expiring at, or built by Senseonics in accordance with this section but not permitted to ship before expiring to, a distributor or physician) shall be solely and entirely for Ascensia’s risk and account if this was included in Ascensia’s Binding Forecast. Senseonics will assist, at Ascensia’s cost, in rekitting 180-day Product inventory that can be repurposed.

Supply Chain Inventory Transition from 180-day Product to 365-day Product.

The Parties shall set a target Product Availability Date for the 365-day Product for each of the US and OUS based on discussion of regulatory status and each latest approval date (“Latest Approval Date”) that supports completing the activities required to support each target Product Availability Date. Senseonics shall regularly update the JAC on its targeted regulatory approvals and the JAC will reasonably adjust target dates based on such discussion or a delay in approval past each Latest Approval Date. Until the respective Product Availability Date of the 365-day Product for the U.S. and O.U.S, the U.S. and O.U.S. Base Forecast demand, respectively, will be delivered in 180-day Product. For each market, if approval for the 365- day Product is reached by the respective Latest Approval Date, then:

●

For U.S. Product scheduled for delivery or sale following the U.S. target Product Availability Date, Senseonics will (i) deliver U.S. Base Forecast demand of commercially-insured DME reimbursed and pharmacy channel product with 365-day Product (subject to Ascensia requesting in the applicable Forecast a percentage of these Sensors to be delivered in 180-day Product, which Senseonics will meet with [***] notice and use commercially reasonable efforts to accommodate with less notice), (ii) deliver U.S. Base Forecast demand of CMS-reimbursed and commercially-reimbursed global payment sensors with 180-day Product, and (iii) begin shipping Incremental Forecast demand. If the Parties are able to secure reimbursement of 365-Product for CMS-reimbursed or

commercially-insured global payment product, the Parties will coordinate to transition promptly to 365-day Product for such Forecast demand.

●

For O.U.S. Product scheduled for delivery of sale following the O.U.S. target Product Availability Date, Senseonics will deliver O.U.S. Forecast demand with 365-day Product (subject to Ascensia requesting in the applicable Forecast a percentage of these Sensors to be delivered in 180-day Product, which Senseonics will meet with [***] notice and use commercially reasonable efforts to accommodate with less notice),

Binding Commitment. Section 2.3(c) of the Agreement will be replaced in its entirety and shall read as follows:

“2.3(c). Binding Commitment. In each Forecast, the following shall constitute a binding commitment for Ascensia to purchase, and for Senseonics to supply, the quantities of Products specified therein, and Ascensia shall order such quantities pursuant to Section 2.2(a) of the Agreement (the “Binding Commitment”):

(i)the first [***] of each [***] – a Binding Commitment for [***] of the quantities of Products specified therein;

(ii)

[***] of each Forecast – a binding commitment for [***] of the quantities of Products specified therein (e.g. Ascensia is allowed to have a reduction/increase in [***] of the next [***] order of up to [***], subject to the limitation on additive reductions set out below);

(iii)

for [***] of each Forecast– a binding commitment for [***] of the quantities of Products specified therein; and

(iv)

for [***] of each Forecast [***] is applicable.

Senseonics obligation to accept a Purchase Order for any increase in a Binding Commitment is subject to its ability to provide the additional Products using commercially reasonable efforts, as set out in Section 2.2(b) of the Agreement. The above-mentioned Binding Commitments are not additive – meaning that (i) if, e.g., a reduction of [***] (or more, to the extent compensated) is taken between [***], there can be no further reduction from [***], and (ii) if, e.g., a reduction of [***] is taken between [***], up to an additional [***] reduction is permissible from [***] without a payment obligation as set out in the next paragraph.

The Binding Commitment for [***] are commitments to purchase. For the Forecasts for [***], for a reduction greater than the allowable percentage ([***], respectively), Ascensia will compensate Senseonics by paying [***]. For the avoidance of doubt and by example: [***].

With respect to quantities of Products in the Binding Commitment, Senseonics shall not be required to ship more than [***] to a single designated distribution facility and/or logistics and kitting provider within the European Union or more than [***] to a single central distribution location in each country in the Territory located outside the United States and European Union, as agreed to by the Parties.

Pricing updates. The Parties shall on a yearly basis - prior to April 1^st of each year, and for the first time before April 1^st, 2025, review in good faith (a) the minimum Transfer Price with consideration of actually realized cost changes resulting from increased volume sales, yield changes, changes in supply or accessory costs, or other changes in the cost of manufacturing, and, if applicable, the utilization of Ascensia supply chain resources to reduce costs as noted in Exhibit D, and (b) the binding collars (months covered and percentages) with a view to minimizing the impact to Senseonics if there is high forecast variability. For the avoidance of doubt, unless Parties explicitly agree on new terms and conditions for the terms mentioned in this Section 9, the then-current terms and conditions will remain valid and applicable for the 180-day Product and the 365-day Product during the Term. Transfer Pricing for any new products will be negotiated in good faith.

10.

Interpretation. Except as expressly provided in this Third Amendment, the Agreement shall continue in full force and effect. The Agreement, as supplemented, clarified or amended by the Letter Agreement of November 17, 2020, the First Amendment dated as of March 31, 2021, the Side Letter Agreement dated November 12, 2021, the Second Side Letter Agreement dated April 5, 2022, and this Third Amendment constitute the entire agreement of the Parties with respect to the subject matter hereof. In the event of any conflict between the terms of this Third Amendment and the Agreement, the terms of this Third Amendment shall control. Except where expressly noted otherwise, the amendments made herein shall be effective as of the Third Amendment Effective Date. Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Agreement. This Third Amendment may be executed in counterparts, each of which shall constitute an original and all of which shall together constitute a single agreement. This Third Amendment may be executed and delivered electronically, including via PDF format or DocuSign, and upon such delivery such electronic signature will be deemed to have the same effect as if the original signature had been delivered to the other Parties.

11.

Confidentiality. The Parties acknowledge that the terms and conditions of this Third Amendment shall be treated as Confidential Information of both Parties, subject to Section 8 of the Agreement.

[Signature Page Follows]

DocuSign Envelope ID: 35D90730-EC4F-4D25-A98D-A04E8D3A617C

CONFIDENTIAL

IN WITNESS WHEREOF, each of the Parties has caused this Third Amendment to be executed by its duly authorized representatives as of the Third Amendment Effective Date.

Ascensia Diabetes Care Holdings AG

By: /s/Marieke Jansen

Name: Marieke Jansen

Title: General Counsel

By: /s/Robert Schumm

Name: Robert Schumm

Title: President, ADC Holdings AG

Senseonics, Incorporated

By: /s/Tim Goodnow

Name: Tim Goodnow

Title: CEO

DocuSign Envelope ID: 35D90730-EC4F-4D25-A98D-A04E8D3A617C

CONFIDENTIAL

EXHIBIT E

Senseonics warrants to Ascensia that the Products will function in material compliance with the applicable Product Specifications. Ascensia’s sole and exclusive remedy for a breach of the foregoing warranty shall be Senseonics’ participation through the True Up in the process outlined below.

Country level end market warranty policies or any limited warranty offered to the end-user or a distribution channel partner will be approved by the Joint Alliance Committee. The Parties intend that such warranty policies or any limited warranty offered to the end-user or a distribution channel partner will not exceed [***] in any market for any 180-day Product/Sensor and will not exceed [***] in any market for any 365-day Product/Sensor.

Any warranty claim by a user will be satisfied out of a sensor taken from Ascensia inventory. For bona fide warranty claims meeting the requirements and terms of the warranty agreed by the Joint Alliance Committee, subject to the minimum price set out in Section 2 hereof, these sensors will be included in the calculation for the true up as follows: replacement sensors will be included in the true up for cost purposes and such sensors that were subject to a bona fide warranty claim will only be included in revenue to the extent they generate revenue in accordance with the end-market warranty, unless otherwise formally agreed by the Joint Alliance Committee for special situations.

Neither Party is liable for the cost of reinsertion and removal of existing Sensor. The Joint Alliance Committee may consider and discuss special situations.

This Amendment shall not affect the currently in-effect transmitter warranty.

EXHIBIT 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Timothy T. Goodnow, Ph.D., certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Senseonics Holdings, Inc. (the “registrant”);

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 8, 2024



	/s/ Timothy T. Goodnow, Ph.D.
	Timothy T. Goodnow, Ph.D.
	President & Chief Executive Officer
	(principal executive officer)

EXHIBIT 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Rick Sullivan, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Senseonics Holdings, Inc. (the “registrant”);

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 8, 2024



	/s/ Rick Sullivan
	Rick Sullivan
	Chief Financial Officer
	(principal financial officer)

EXHIBIT 32.1

CERTIFICATIONS OF

PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Timothy T. Goodnow, Ph.D., President and Chief Executive Officer of Senseonics Holdings, Inc. (the “Company”), and Rick Sullivan, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:

The Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 (the “Quarterly Report”), to which this Certification is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and

The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

In Witness Whereof, the undersigned have set their hands hereto as of the 8th day of August 2024.



/s/ Timothy T. Goodnow, Ph.D.		/s/ Rick Sullivan
Timothy T. Goodnow, Ph.D.		Rick Sullivan
President & Chief Executive Officer		Chief Financial Officer
(principal executive officer)		(principal financial officer)

*This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2024	Aug. 02, 2024
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2024
Document Transition Report	false
Entity File Number	001-37717
Entity Registrant Name	Senseonics Holdings, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-1210911
Entity Address, Address Line One	20451 Seneca Meadows Parkway
Entity Address, City or Town	Germantown
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20876-7005
City Area Code	301
Local Phone Number	515-7260
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	SENS
Security Exchange Name	NYSEAMER
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		535,574,088
Entity Central Index Key	0001616543
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q2
Amendment Flag	false

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 34,853	$ 75,709
Restricted cash	318
Short term investments, net	49,774	33,747
Inventory, net	7,215	8,776
Prepaid expenses and other current assets	6,502	7,266
Total current assets	103,014	130,030
Deposits and other assets	5,241	7,006
Property and equipment, net	3,306	1,184
Total assets	111,561	138,220
Current liabilities:
Accounts payable	1,331	4,568
Accrued expenses and other current liabilities	13,142	12,689
Note payable, current portion, net	18,642
Total current liabilities	33,115	17,257
Long-term debt and notes payables, net	34,202	41,195
Derivative liabilities		102
Other liabilities	6,010	6,214
Total liabilities	73,327	64,768
Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares authorized and 12,000 shares issued and outstanding as of June 30, 2024 and December 31, 2023	37,656	37,656
Total temporary equity	37,656	37,656
Commitments and contingencies
Stockholders' equity:
Common stock, $0.001 par value per share; 1,400,000,000 shares and 900,000 shares authorized as of June 30, 2024 and December 31, 2023; 535,277,362 shares and 530,364,237 shares issued and outstanding as of June 30, 2024 and December 31, 2023	535	530
Additional paid-in capital	908,472	904,535
Accumulated other comprehensive loss	(7)	(11)
Accumulated deficit	(908,422)	(869,258)
Total stockholders' equity	578	35,796
Total liabilities and stockholders' equity	111,561	138,220
Nonrelated Party
Current assets:
Accounts receivable, net	1,277	808
Current liabilities:
Accrued expenses and other current liabilities	11,916	11,744
Related Party
Current assets:
Accounts receivable, net	3,075	3,724
Current liabilities:
Accrued expenses and other current liabilities	$ 1,226	$ 945

Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares	Jun. 30, 2024	Dec. 31, 2023
Class of stock information
Temporary equity, par or stated value per share (in dollars per share)	$ 0.001	$ 0.001
Temporary equity, shares authorized	12,000	12,000
Temporary equity, shares issued	12,000	12,000
Temporary equity, shares outstanding	12,000	12,000
Common stock, par value per share (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	1,400,000,000	900,000,000
Common stock, shares issued	535,277,362	530,364,237
Common stock, shares outstanding	535,277,362	530,364,237

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Revenue, net	$ 4,865	$ 4,126	$ 9,912	$ 8,263
Cost of sales	4,567	3,709	9,279	7,433
Gross profit	298	417	633	830
Expenses:
Research and development expenses	10,800	12,830	21,238	25,235
Selling, general and administrative expenses	8,991	7,455	17,119	15,173
Operating loss	(19,493)	(19,868)	(37,724)	(39,578)
Other (expense) income, net:
Interest income	1,190	1,311	2,574	2,420
Exchange related gain, net				18,776
Interest expense	(2,085)	(2,310)	(4,133)	(6,962)
Gain on change in fair value of derivatives	102	289	102	6,067
Other (expense) income	(1)	155	17	178
Total other (expense) income, net	(794)	(555)	(1,440)	20,479
Net Loss	(20,287)	(20,423)	(39,164)	(19,099)
Other comprehensive income
Unrealized (loss) gain on marketable securities	(5)	100	4	558
Total other comprehensive (loss) gain	(5)	100	4	558
Total comprehensive loss	$ (20,292)	$ (20,323)	$ (39,160)	$ (18,541)
Basic net loss per common share	$ (0.03)	$ (0.04)	$ (0.06)	$ (0.04)
Basic weighted-average shares outstanding	616,585,664	567,125,022	615,587,105	532,499,776
Diluted net loss per common share	$ (0.03)	$ (0.04)	$ (0.06)	$ (0.04)
Diluted weighted-average shares outstanding	616,585,664	567,125,022	615,587,105	532,499,776
Nonrelated Party
Revenue, net	$ 778	$ 437	$ 1,367	$ 750
Related Party
Revenue, net	$ 4,087	$ 3,689	$ 8,545	$ 7,513

Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) shares in Thousands, $ in Thousands	Preferred Stock Series B Preferred Stock	Common Stock	Additional Paid-In Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit	Total
Balance at Dec. 31, 2022		$ 480	$ 806,488	$ (678)	$ (808,866)	$ (2,576)
Balance (in shares) at Dec. 31, 2022		479,637
Changes in Stockholders' Equity (Deficit)
Issuance of common stock, net of issuance costs		$ 10	7,366			7,376
Issuance of common stock, net of issuance costs (in shares)		9,945
Issued common stock for vested RSUs and ESPP purchase		$ 5	82			87
Issued common stock for vested RSUs and ESPP purchase (in shares)		5,371
Issuance of warrants, net of issuance costs			63,282			63,282
Exercise of stock options and warrants			3			3
Exercise of stock options and warrants (in shares)		6
Stock-based compensation expense			4,651			4,651
Shares withheld related to net share settlement of equity awards		$ (2)	(1,601)			(1,603)
Shares withheld related to net share settlement of equity awards (in shares)		(2,132)
Other			(142)			(142)
Net loss					(19,099)	(19,099)
Other comprehensive income (loss), net of tax				558		558
Balance at Jun. 30, 2023		$ 493	880,129	(120)	(827,965)	52,537
Balance (in shares) at Jun. 30, 2023		492,827
Temporary Equity, Beginning Balance at Dec. 31, 2022	$ 37,656
Temporary Equity, Ending Balance at Jun. 30, 2023	37,656
Balance at Dec. 31, 2022		$ 480	806,488	(678)	(808,866)	(2,576)
Balance (in shares) at Dec. 31, 2022		479,637
Changes in Stockholders' Equity (Deficit)
Net loss						(60,400)
Balance at Dec. 31, 2023		$ 530	904,535	(11)	(869,258)	35,796
Balance (in shares) at Dec. 31, 2023		530,364
Temporary Equity, Beginning Balance at Dec. 31, 2022	37,656
Temporary Equity, Ending Balance at Dec. 31, 2023	37,656
Balance at Mar. 31, 2023		$ 480	871,746	(220)	(807,542)	64,464
Balance (in shares) at Mar. 31, 2023		479,780
Changes in Stockholders' Equity (Deficit)
Issuance of common stock, net of issuance costs		$ 10	7,366			7,376
Issuance of common stock, net of issuance costs (in shares)		9,945
Issued common stock for vested RSUs and ESPP purchase		$ 5	(3)			2
Issued common stock for vested RSUs and ESPP purchase (in shares)		5,228
Warrant issuance costs			(260)			(260)
Exercise of stock options and warrants			3			3
Exercise of stock options and warrants (in shares)		6
Stock-based compensation expense			2,870			2,870
Shares withheld related to net share settlement of equity awards		$ (2)	(1,596)			(1,598)
Shares withheld related to net share settlement of equity awards (in shares)		(2,132)
Other			3			3
Net loss					(20,423)	(20,423)
Other comprehensive income (loss), net of tax				100		100
Balance at Jun. 30, 2023		$ 493	880,129	(120)	(827,965)	52,537
Balance (in shares) at Jun. 30, 2023		492,827
Temporary Equity, Beginning Balance at Mar. 31, 2023	37,656
Temporary Equity, Ending Balance at Jun. 30, 2023	37,656
Balance at Dec. 31, 2023		$ 530	904,535	(11)	(869,258)	35,796
Balance (in shares) at Dec. 31, 2023		530,364
Changes in Stockholders' Equity (Deficit)
Issuance of common stock, net of issuance costs		$ 1	(1)
Issuance of common stock, net of issuance costs (in shares)		728
Issued common stock for vested RSUs and ESPP purchase		$ 6	95			101
Issued common stock for vested RSUs and ESPP purchase (in shares)		6,489
Issuance of warrants, net of issuance costs			149			149
Exercise of stock options and warrants			6			6
Exercise of stock options and warrants (in shares)		12
Stock-based compensation expense			4,727			4,727
Shares withheld related to net share settlement of equity awards		$ (2)	(1,039)			(1,041)
Shares withheld related to net share settlement of equity awards (in shares)		(2,316)
Net loss					(39,164)	(39,164)
Other comprehensive income (loss), net of tax				4		4
Balance at Jun. 30, 2024		$ 535	908,472	(7)	(908,422)	578
Balance (in shares) at Jun. 30, 2024		535,277
Temporary Equity, Beginning Balance at Dec. 31, 2023	37,656
Temporary Equity, Ending Balance at Jun. 30, 2024	37,656
Balance at Mar. 31, 2024		$ 530	906,569	(2)	(888,135)	18,962
Balance (in shares) at Mar. 31, 2024		530,818
Changes in Stockholders' Equity (Deficit)
Issuance of common stock, net of issuance costs		$ 1				1
Issuance of common stock, net of issuance costs (in shares)		620
Issued common stock for vested RSUs and ESPP purchase		$ 6				6
Issued common stock for vested RSUs and ESPP purchase (in shares)		6,122
Exercise of stock options and warrants			5			5
Exercise of stock options and warrants (in shares)		11
Stock-based compensation expense			2,926			2,926
Shares withheld related to net share settlement of equity awards		$ (2)	(1,028)			(1,030)
Shares withheld related to net share settlement of equity awards (in shares)		(2,294)
Net loss					(20,287)	(20,287)
Other comprehensive income (loss), net of tax				(5)		(5)
Balance at Jun. 30, 2024		$ 535	$ 908,472	$ (7)	$ (908,422)	$ 578
Balance (in shares) at Jun. 30, 2024		535,277
Temporary Equity, Beginning Balance at Mar. 31, 2024	37,656
Temporary Equity, Ending Balance at Jun. 30, 2024	$ 37,656

Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Cash flows from operating activities
Net loss	$ (39,164)	$ (19,099)
Adjustments to reconcile net (loss) income to net cash used in operating activities:
Depreciation and ROU amortization expense	513	454
Non-cash interest expense (debt discount and deferred costs)	1,848	2,014
Net amortization of premiums and accretion of discounts on marketable securities	(282)	1,412
Gain on change in fair value of derivatives	(102)	(6,067)
Exchange related gain, net		(18,776)
Stock-based compensation expense	4,727	4,651
Provision for inventory obsolescence	52	(65)
Other	341	55
Changes in assets and liabilities:
Accounts receivable	115	(1,224)
Prepaid expenses and other current assets	765	(314)
Inventory	1,509	(1,823)
Deposits and other assets	1,596	(26)
Accounts payable	(3,296)	556
Accrued expenses and other liabilities	348	493
Accrued interest	76	357
Operating lease liabilities	(450)	(430)
Net cash used in operating activities	(31,404)	(37,832)
Cash flows from investing activities
Capital expenditures	(2,408)	(57)
Purchase of marketable securities	(49,637)	(61,818)
Proceeds from sale and maturity of marketable securities	33,895	87,746
Net cash provided by (used in) investing activities	(18,150)	25,871
Cash flows from financing activities
Proceeds from issuance of common stock, net		7,376
Proceeds from exercise of stock options and ESPP issuances, net	107	(52)
Proceeds from issuance of term loan, net	9,950
Taxes paid related to net share settlement of equity awards	(1,041)	(1,603)
Repayment of 2023 Notes		(15,700)
Proceeds from issuance of warrants, net		14,698
Net cash provided by financing activities	9,016	4,719
Net decrease in cash, cash equivalents	(40,538)	(7,242)
Cash, cash equivalents, and restricted cash at beginning of period	75,709	35,793
Cash, cash equivalents, and restricted cash at ending of period	35,171	28,551
Supplemental disclosure of cash flow information
Cash paid during the period for interest	2,209	1,756
Lease liabilities arising from obtaining right-of-use assets		3,831
Supplemental disclosure of non-cash investing and financing activities
Property and equipment purchases included in accounts payable and accrued expenses	37
Issuance of warrants in exchange for PHC Notes		$ 48,564
Issuance of warrants for Loan and Security Agreement	$ 149

Organization and Nature of Operations

6 Months Ended

Jun. 30, 2024

Organization and Nature of Operations

Organization and Nature of Operations

1.	Organization and Nature of Operations

Liquidity and Capital Resources

6 Months Ended

Jun. 30, 2024

Liquidity and Capital Resources

Liquidity and Capital Resources

2.	Liquidity and Capital Resources

Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2024

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

3.	Summary of Significant Accounting Policies

Basis of Presentation

Recent Accounting Pronouncements

Use of Estimates

Significant Accounting Policies

Revenue Recognition

6 Months Ended

Jun. 30, 2024

Revenue Recognition

Revenue Recognition

4. Revenue Recognition

Revenue by Geographic Region


	Three Months Ended				Six Months Ended
	June 30, 2024				June 30, 2024
			%				%
(Dollars in thousands)	Amount		of Total		Amount		of Total
Revenue, net:
United States	$	3,030	62.3	%	$	6,706	67.7	%
Outside of the United States		1,835	37.7			3,206	32.3
Total	$	4,865	100.0	%	$	9,912	100.0	%


	Three Months Ended				Six Months Ended
	June 30, 2023				June 30, 2023
			%				%
(Dollars in thousands)	Amount		of Total		Amount		of Total
Revenue, net:
United States	$	1,793	43.5	%	$	3,955	47.9	%
Outside of the United States		2,333	56.5			4,308	52.1
Total	$	4,126	100.0	%	$	8,263	100.0	%

Contract Assets

Concentration of Revenue and Customers

Net Loss per Share

6 Months Ended

Jun. 30, 2024

Net Loss per Share

Net Loss per Share

5. Net Loss per Share

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:


		Three Months Ended June 30,				Six Months Ended June 30,
		2024		2023		2024		2023

Net loss	$	(20,287)	$	(20,423)	$	(39,164)	$	(19,099)

Impact of conversion of dilutive securities		—		—		—		—

Dilutive Net loss	$	(20,287)	$	(20,423)	$	(39,164)	$	(19,099)

Net loss per share
Basic	$	(0.03)	$	(0.04)	$	(0.06)	$	(0.04)
Diluted	$	(0.03)	$	(0.04)	$	(0.06)	$	(0.04)

Basic weighted average shares outstanding		616,585,664		567,125,022		615,587,105		532,499,776
Dilutive potential common stock outstanding
Dilutive potential common stock outstanding		—		—		—		—
Diluted weighted average shares outstanding		616,585,664		567,125,022		615,587,105		532,499,776

Outstanding anti-dilutive securities not included in the diluted net loss per share calculations were as follows:


	Three Months Ended June 30,		Six Months Ended June 30,
	2024	2023	2024	2023
Stock-based awards	44,689,681	31,785,464	44,689,681	31,785,464
2025 Notes	15,813,176	39,689,142	15,813,176	39,689,142
Energy Capital Preferred Shares	30,372,058	30,372,058	30,372,058	30,372,058
Warrants	1,608,070	427,821	1,608,070	427,821
Total anti-dilutive shares outstanding	92,482,985	102,274,485	92,482,985	102,274,485

Marketable Securities

6 Months Ended

Jun. 30, 2024

Marketable Securities

Marketable Securities

6.	Marketable Securities

Marketable securities available for sale, were as follows (in thousands):


	June 30, 2024
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Market
	Cost		Gains		Losses		Value
Commercial Paper	$	11,783	$	—	$	(8)	$	11,775
Government and agency securities		37,998		1		—		37,999
Total	$	49,781	$	1	$	(8)	$	49,774


	December 31, 2023
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Market
	Cost		Gains		Losses		Value
Commercial Paper	$	7,598	$	—	$	—	$	7,598
Corporate debt securities		7,980		1		—		7,981
Government and agency securities		18,180		—		(12)		18,168
Total	$	33,758	$	1	$	(12)	$	33,747

The following are the scheduled maturities as of June 30, 2024 (in thousands):


	Net		Fair
	Carrying Amount		Value
2024 (remaining six months)	$	49,781	$	49,774
Total	$	49,781	$	49,774

Inventory, net

6 Months Ended

Jun. 30, 2024

Inventory, net

Inventory, net

7. Inventory, net

Inventory, net of reserves, consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Finished goods	$	1,209	$	2,160
Work-in-process		4,766		5,332
Raw materials		1,240		1,284
Total	$	7,215	$	8,776

Prepaid Expenses and Other Current Assets

6 Months Ended

Jun. 30, 2024

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

8. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Contract manufacturing⁽¹⁾	$	3,571	$	4,244
Tax credits receivable⁽²⁾		1,793		1,793
Insurance		487		73
Clinical and Preclinical		304		343
IT and software		125		242
Rent and utilities		99		122
Sales and Marketing		70		20
Investor Relations		39		—
Research and development		14		95
Interest receivable		—		272
Accounting and Audit		—		61
Other		—		1
Total prepaid expenses and other current assets	$	6,502	$	7,266

(1)

Includes deposits to contract manufacturers for manufacturing process.

(2)

Refundable employee retention credits, enacted under the CARES Act.

Accrued Expenses and Other Current Liabilities

6 Months Ended

Jun. 30, 2024

Accrued Expenses and Other Current Liabilities

Accrued Expenses and Other Current Liabilities

9.	Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Research and development	$	4,515	$	3,846
Compensation and benefits		2,771		4,799
Professional and administrative services		2,208		673
Contract manufacturing		1,024		1,457
Interest on notes payable		780		704
Sales and marketing services		577		301
Product warranty and replacement obligations		459		514
Accrued construction and renovation costs		399		—
Operating lease		398		368
Other		11		27
Total accrued expenses and other current liabilities	$	13,142	$	12,689

Leases

6 Months Ended

Jun. 30, 2024

Leases

Leases

10.

Leases

Operating lease expense for both the six months ended June 30, 2024 and 2023 was $0.4 million.

The following table summarizes the lease assets and liabilities as of June 30, 2024 and December 31, 2023 (in thousands):


				June 30,		December 31,
Operating Lease Assets and Liabilities	Balance Sheet Classification		2024		2023
Assets
Operating lease ROU assets		Deposits and other assets	$	5,012	$	5,180
Liabilities
Current operating lease liabilities		Accrued expenses and other current liabilities	$	398	$	368
Non-current operating lease liabilities		Other non-current liabilities		6,010		6,214
Total operating lease liabilities			$	6,408	$	6,582

The following table summarizes the maturity of undiscounted payments due under operating lease liabilities and the present value of those liabilities as of June 30, 2024 (in thousands):


2024 (remaining 6 months)	$	461
2025		939
2026		967
2027		996
2028		1,026
Thereafter		4,908
Total		9,297
Less: Present value adjustment		(2,889)
Present value of lease liabilities	$	6,408

The following table summarizes the weighted-average lease term and weighted-average discount rate as of June 30, 2024:


Remaining lease term (years)	2024
Operating leases	8.9
Discount rate
Operating leases	8.5	%

Product Warranty Obligations

6 Months Ended

Jun. 30, 2024

Product Warranty Obligations

Product Warranty Obligations

11.

Product Warranty Obligations


	June 30,		December 31,
	2024		2023
Balance at beginning of the period	$	514	$	781
Provision for warranties during the period		125		242
Settlements made during the period		(180)		(509)
Balance at end of the period	$	459	$	514

Notes Payable, Preferred Stock and Stock Purchase Warrants

6 Months Ended

Jun. 30, 2024

Notes Payable, Preferred Stock and Stock Purchase Warrants

Notes Payable, Preferred Stock and Stock Purchase Warrants

12.

Notes Payable, Preferred Stock and Stock Purchase Warrants

Term Loans

Loan and Security Agreement

Convertible Preferred Stock and Warrants

Securities Purchase Agreement

Convertible Notes

PHC Notes

2025 Notes

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 $30.8 million in aggregate principal amount of the 2025 Notes (the “Exchanged Notes”) for a combination of $7.5 million of cash and newly issued shares of common stock (the “Exchange Shares”). The number of Exchange Shares was determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period commencing on August 11, 2023 and ending August 31, 2023. Based on the volume-weighted average price per share of the common stock during the averaging period, a total of 35.1 million shares of common stock were issued in the Exchanges. The Exchanges were settled on the initial share issuance date of August 14, 2023 and the final settlement date of September 5, 2023.

2023 Notes

The following carrying amounts were outstanding under the Company’s notes payable as of June 30, 2024 and December 31, 2023 (in thousands):


	June 30, 2024
	Principal ($)	Debt (Discount) Premium ($)⁽¹⁾	Issuance Costs ($)	Carrying Amount ($)
2025 Notes	20,399	(1,728)	(29)	18,642
Loan and Security Agreement	35,000	(505)	(293)	34,202

	December 31, 2023
	Principal ($)	Debt (Discount) Premium ($)⁽¹⁾	Issuance Costs ($)	Carrying Amount ($)
2025 Notes	20,399	(3,090)	(52)	17,257
Loan and Security Agreement	25,000	(733)	(329)	23,938

(1)

Includes accretion of end of term fees payable at maturity

Interest expense related to the notes payable for the six months ended June 30, 2024 and 2023 was as follows (dollars in thousands):


	Six Months Ended June 30, 2024
	Interest Rate	Interest ($)	Debt Discount and Fees ($)⁽¹⁾	Issuance Costs ($)	Total Interest Expense ($)
2025 Notes	5.25%	535	1,362	23	1,920
Loan and Security Agreement	9.90%	1,749	427	37	2,213
Total		2,284	1,789	60	4,133


	Six Months Ended June 30, 2023
	Interest Rate	Interest ($)	Debt Discount and Fees ($)⁽¹⁾	Issuance Costs ($)	Total Interest Expense ($)
2023 Notes	5.25%	69	120	-	189
2025 Notes	5.25%	1,344	3,146	53	4,543
PHC Notes	8.00%	700	1,442	88	2,230
Total		2,113	4,708	141	6,962

(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 June 30, 2024 (in thousands):


2025		20,399
2026		12,996
2027		24,437
Total	$	57,832

Stockholders' Equity

6 Months Ended

Jun. 30, 2024

Stockholders' Equity

Stockholders' Equity

13.

Stockholders’ Equity

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 will receive a commission up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares of the Company’s common stock will be offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed by the Company with the Securities and Exchange Commission on August 10, 2023. For the period ending June 30, 2024, the Company received approximately $0.3 million in net proceeds from the sale of 728,291 shares of its common stock under the Equity Distribution Agreement.

Stock-Based Compensation

6 Months Ended

Jun. 30, 2024

Stock-Based Compensation

Stock-Based Compensation

14. Stock-Based Compensation

2015 Plan

Inducement Plan

Commercial Equity Plan

2016 Employee Stock Purchase Plan

offering is less than or equal to the fair market value of a share on a new offering date, the ongoing offering will terminate immediately after the purchase date and rolls over to the new offering.

The 2016 ESPP is considered compensatory for financial reporting purposes.

1997 Plan

Fair Value Measurements

6 Months Ended

Jun. 30, 2024

Fair Value Measurements

Fair Value Measurements

15.

Fair Value Measurements


	June 30, 2024
	Total		Level 1		Level 2		Level 3
Assets
Money market funds⁽¹⁾	$	33,901	$	33,901		—		—
Commercial paper		11,775		—		11,775		—
Government and agency securities		37,999		37,399		—		—


	December 31, 2023
	Total		Level 1		Level 2		Level 3
Assets
Money market funds⁽¹⁾	$	72,953	$	72,953		—		—
Commercial paper		7,598		—		7,598		—
Corporate debt securities		7,982		—		7,982		—
Government and agency securities		18,167		18,167		—		—
Liabilities
Embedded features of the 2025 Notes	$	102		—		—		102

(1)Classified as cash and cash equivalents due to their short-term maturity



	Level 3
	Instruments
December 31, 2023	$	102
Conversion of financial instruments		—
Gain on change in fair value of embedded features of the 2025 Notes		(102)
June 30, 2024	$	—

The recurring Level 3 fair value measurements of the embedded features of the notes payable and preferred stock, include the following significant unobservable inputs at June 30, 2024:




		2025 Notes
Unobservable Inputs	`	Assumptions
Stock price volatility		45.0	%
Probabilities of conversion provisions		10-90	%
Credit spread		14.3	%

Income Taxes

6 Months Ended

Jun. 30, 2024

Income Taxes

Income Taxes

16.

Income Taxes

Related Party Transactions

6 Months Ended

Jun. 30, 2024

Related Party Transactions

Related Party Transactions

17. Related Party Transactions

Subsequent Events

6 Months Ended

Jun. 30, 2024

Subsequent Events

Subsequent Events

18. Subsequent Events

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended		6 Months Ended		12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Pay vs Performance Disclosure
Net Income (Loss)	$ (20,287)	$ (20,423)	$ (39,164)	$ (19,099)	$ (60,400)	$ 142,100

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Jun. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Summary of Significant Accounting Policies (Policies)	6 Months Ended
Summary of Significant Accounting Policies (Policies)	Jun. 30, 2024
Summary of Significant Accounting Policies
Basis of Presentation	Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“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 June 30, 2024, and December 31, 2023, results of operations, comprehensive income (loss), and changes in stockholder’s deficit for the three and six months ended June 30, 2024 and 2023 and cash flows for the six months ended June 30, 2024 and 2023 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, 2023, as filed with the SEC on March 1, 2024. The interim results for June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, 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 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, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, and minimum cash and satisfaction of performance milestones to comply with debt covenants under its 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 wholly owned operating subsidiary Senseonics, Incorporated. The Company views its operations and manages its business in one segment, glucose monitoring products. Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.
Recent Accounting Pronouncements	Recent Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires that an entity report segment information in accordance with Topic 280, Segment Reporting. The amendment in the ASU is intended to improve reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses. The amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, on a retrospective basis, with early adoption permitted. The Company is currently evaluating the impact of the new standard on its financial statements and disclosures. 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 fiscal years beginning after December 15, 2024, or our fiscal year 2025, using either a prospective or retrospective transition method, and early adoption is permitted. The Company is currently evaluating the impact of the new standard on its financial statements and disclosures.
Use of Estimates	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, 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, 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.

Revenue Recognition (Tables)

6 Months Ended

Jun. 30, 2024

Revenue Recognition

Schedule of revenue by geographic region


	Three Months Ended				Six Months Ended
	June 30, 2024				June 30, 2024
			%				%
(Dollars in thousands)	Amount		of Total		Amount		of Total
Revenue, net:
United States	$	3,030	62.3	%	$	6,706	67.7	%
Outside of the United States		1,835	37.7			3,206	32.3
Total	$	4,865	100.0	%	$	9,912	100.0	%


	Three Months Ended				Six Months Ended
	June 30, 2023				June 30, 2023
			%				%
(Dollars in thousands)	Amount		of Total		Amount		of Total
Revenue, net:
United States	$	1,793	43.5	%	$	3,955	47.9	%
Outside of the United States		2,333	56.5			4,308	52.1
Total	$	4,126	100.0	%	$	8,263	100.0	%

Net Loss per Share (Tables)

6 Months Ended

Jun. 30, 2024

Net Loss per Share

Schedule of computation of basic and diluted net loss per share


		Three Months Ended June 30,				Six Months Ended June 30,
		2024		2023		2024		2023

Net loss	$	(20,287)	$	(20,423)	$	(39,164)	$	(19,099)

Impact of conversion of dilutive securities		—		—		—		—

Dilutive Net loss	$	(20,287)	$	(20,423)	$	(39,164)	$	(19,099)

Net loss per share
Basic	$	(0.03)	$	(0.04)	$	(0.06)	$	(0.04)
Diluted	$	(0.03)	$	(0.04)	$	(0.06)	$	(0.04)

Basic weighted average shares outstanding		616,585,664		567,125,022		615,587,105		532,499,776
Dilutive potential common stock outstanding
Dilutive potential common stock outstanding		—		—		—		—
Diluted weighted average shares outstanding		616,585,664		567,125,022		615,587,105		532,499,776

Schedule of anti-dilutive shares which have been excluded from the computation of diluted net loss per share


	Three Months Ended June 30,		Six Months Ended June 30,
	2024	2023	2024	2023
Stock-based awards	44,689,681	31,785,464	44,689,681	31,785,464
2025 Notes	15,813,176	39,689,142	15,813,176	39,689,142
Energy Capital Preferred Shares	30,372,058	30,372,058	30,372,058	30,372,058
Warrants	1,608,070	427,821	1,608,070	427,821
Total anti-dilutive shares outstanding	92,482,985	102,274,485	92,482,985	102,274,485

Marketable Securities (Tables)

6 Months Ended

Jun. 30, 2024

Marketable Securities

Schedule of marketable securities available for sale

Marketable securities available for sale, were as follows (in thousands):


	June 30, 2024
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Market
	Cost		Gains		Losses		Value
Commercial Paper	$	11,783	$	—	$	(8)	$	11,775
Government and agency securities		37,998		1		—		37,999
Total	$	49,781	$	1	$	(8)	$	49,774


	December 31, 2023
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Market
	Cost		Gains		Losses		Value
Commercial Paper	$	7,598	$	—	$	—	$	7,598
Corporate debt securities		7,980		1		—		7,981
Government and agency securities		18,180		—		(12)		18,168
Total	$	33,758	$	1	$	(12)	$	33,747

Schedule of maturities of marketable securities

The following are the scheduled maturities as of June 30, 2024 (in thousands):


	Net		Fair
	Carrying Amount		Value
2024 (remaining six months)	$	49,781	$	49,774
Total	$	49,781	$	49,774

Inventory, net (Tables)

6 Months Ended

Jun. 30, 2024

Inventory, net

Schedule of Inventory, net

Inventory, net of reserves, consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Finished goods	$	1,209	$	2,160
Work-in-process		4,766		5,332
Raw materials		1,240		1,284
Total	$	7,215	$	8,776

Prepaid Expenses and Other Current Assets (Tables)

6 Months Ended

Jun. 30, 2024

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Contract manufacturing⁽¹⁾	$	3,571	$	4,244
Tax credits receivable⁽²⁾		1,793		1,793
Insurance		487		73
Clinical and Preclinical		304		343
IT and software		125		242
Rent and utilities		99		122
Sales and Marketing		70		20
Investor Relations		39		—
Research and development		14		95
Interest receivable		—		272
Accounting and Audit		—		61
Other		—		1
Total prepaid expenses and other current assets	$	6,502	$	7,266

(1)

Includes deposits to contract manufacturers for manufacturing process.

(2)

Refundable employee retention credits, enacted under the CARES Act.

Accrued Expenses and Other Current Liabilities (Tables)

6 Months Ended

Jun. 30, 2024

Accrued Expenses and Other Current Liabilities

Schedule of accrued expenses and other current liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	June 30,		December 31,
	2024		2023
Research and development	$	4,515	$	3,846
Compensation and benefits		2,771		4,799
Professional and administrative services		2,208		673
Contract manufacturing		1,024		1,457
Interest on notes payable		780		704
Sales and marketing services		577		301
Product warranty and replacement obligations		459		514
Accrued construction and renovation costs		399		—
Operating lease		398		368
Other		11		27
Total accrued expenses and other current liabilities	$	13,142	$	12,689

Leases (Tables)

6 Months Ended

Jun. 30, 2024

Leases

Summary of lease assets and liabilities

The following table summarizes the lease assets and liabilities as of June 30, 2024 and December 31, 2023 (in thousands):


				June 30,		December 31,
Operating Lease Assets and Liabilities	Balance Sheet Classification		2024		2023
Assets
Operating lease ROU assets		Deposits and other assets	$	5,012	$	5,180
Liabilities
Current operating lease liabilities		Accrued expenses and other current liabilities	$	398	$	368
Non-current operating lease liabilities		Other non-current liabilities		6,010		6,214
Total operating lease liabilities			$	6,408	$	6,582

Schedule of operating lease liabilities maturities

The following table summarizes the maturity of undiscounted payments due under operating lease liabilities and the present value of those liabilities as of June 30, 2024 (in thousands):


2024 (remaining 6 months)	$	461
2025		939
2026		967
2027		996
2028		1,026
Thereafter		4,908
Total		9,297
Less: Present value adjustment		(2,889)
Present value of lease liabilities	$	6,408

Schedule of lease term and discount rate

The following table summarizes the weighted-average lease term and weighted-average discount rate as of June 30, 2024:


Remaining lease term (years)	2024
Operating leases	8.9
Discount rate
Operating leases	8.5	%

Product Warranty Obligations (Tables)

6 Months Ended

Jun. 30, 2024

Product Warranty Obligations

Schedule of change in estimated warranty liabilities

The following table provides a reconciliation of the change in estimated warranty liabilities for the six months ended June 30, 2024, and for the twelve months ended December 31, 2023 (in thousands):


	June 30,		December 31,
	2024		2023
Balance at beginning of the period	$	514	$	781
Provision for warranties during the period		125		242
Settlements made during the period		(180)		(509)
Balance at end of the period	$	459	$	514

Notes Payable, Preferred Stock and Stock Purchase Warrants (Tables)

6 Months Ended

Jun. 30, 2024

Notes Payable, Preferred Stock and Stock Purchase Warrants

Schedule of carrying amounts outstanding under the Company's notes payable

The following carrying amounts were outstanding under the Company’s notes payable as of June 30, 2024 and December 31, 2023 (in thousands):


	June 30, 2024
	Principal ($)	Debt (Discount) Premium ($)⁽¹⁾	Issuance Costs ($)	Carrying Amount ($)
2025 Notes	20,399	(1,728)	(29)	18,642
Loan and Security Agreement	35,000	(505)	(293)	34,202

	December 31, 2023
	Principal ($)	Debt (Discount) Premium ($)⁽¹⁾	Issuance Costs ($)	Carrying Amount ($)
2025 Notes	20,399	(3,090)	(52)	17,257
Loan and Security Agreement	25,000	(733)	(329)	23,938

(1)

Includes accretion of end of term fees payable at maturity

Schedule of interest expense related to the notes payable

Interest expense related to the notes payable for the six months ended June 30, 2024 and 2023 was as follows (dollars in thousands):


	Six Months Ended June 30, 2024
	Interest Rate	Interest ($)	Debt Discount and Fees ($)⁽¹⁾	Issuance Costs ($)	Total Interest Expense ($)
2025 Notes	5.25%	535	1,362	23	1,920
Loan and Security Agreement	9.90%	1,749	427	37	2,213
Total		2,284	1,789	60	4,133


	Six Months Ended June 30, 2023
	Interest Rate	Interest ($)	Debt Discount and Fees ($)⁽¹⁾	Issuance Costs ($)	Total Interest Expense ($)
2023 Notes	5.25%	69	120	-	189
2025 Notes	5.25%	1,344	3,146	53	4,543
PHC Notes	8.00%	700	1,442	88	2,230
Total		2,113	4,708	141	6,962

(1)

Includes accretion of end of term fees payable at maturity

Schedule of future maturities

The following are the scheduled maturities of the Company’s notes payable (including end of term fees) as of June 30, 2024 (in thousands):


2025		20,399
2026		12,996
2027		24,437
Total	$	57,832

Fair Value Measurements (Tables)

6 Months Ended

Jun. 30, 2024

Fair Value Measurements

Schedule of fair value hierarchy of the Company's financial assets and liabilities measured at fair value on a recurring basis


	June 30, 2024
	Total		Level 1		Level 2		Level 3
Assets
Money market funds⁽¹⁾	$	33,901	$	33,901		—		—
Commercial paper		11,775		—		11,775		—
Government and agency securities		37,999		37,399		—		—


	December 31, 2023
	Total		Level 1		Level 2		Level 3
Assets
Money market funds⁽¹⁾	$	72,953	$	72,953		—		—
Commercial paper		7,598		—		7,598		—
Corporate debt securities		7,982		—		7,982		—
Government and agency securities		18,167		18,167		—		—
Liabilities
Embedded features of the 2025 Notes	$	102		—		—		102

(1)Classified as cash and cash equivalents due to their short-term maturity

Schedule of changes in the fair value of Level 3 derivative liability measured at fair value



	Level 3
	Instruments
December 31, 2023	$	102
Conversion of financial instruments		—
Gain on change in fair value of embedded features of the 2025 Notes		(102)
June 30, 2024	$	—

Schedule of assumptions used to determine fair value




		2025 Notes
Unobservable Inputs	`	Assumptions
Stock price volatility		45.0	%
Probabilities of conversion provisions		10-90	%
Credit spread		14.3	%

Liquidity and Capital Resources (Details) - USD ($) $ / shares in Units, $ in Thousands					1 Months Ended		3 Months Ended		5 Months Ended	6 Months Ended		11 Months Ended	12 Months Ended
	Jan. 02, 2024	Aug. 10, 2023	Aug. 07, 2023	Mar. 13, 2023	Aug. 31, 2023	Nov. 30, 2021	Jun. 30, 2024	Jun. 30, 2023	Jan. 27, 2021	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Dec. 31, 2023	Dec. 31, 2022	Sep. 08, 2023	Mar. 31, 2023	Apr. 30, 2022	Aug. 09, 2020	Jul. 31, 2019
Net loss							$ (20,287)	$ (20,423)		$ (39,164)	$ (19,099)		$ (60,400)	$ 142,100
Gross profit (loss)							298	417		633	830
Accumulated deficit							(908,422)			(908,422)		$ (908,422)	$ (869,258)
Cash, cash equivalents and marketable securities							$ 84,600			$ 84,600		$ 84,600
Common stock, par value per share (in dollars per share)							$ 0.001			$ 0.001		$ 0.001	$ 0.001
Issuance of common stock, net of issuance costs							$ 1	$ 7,376			$ 7,376
PHC Purchase Warrant
Beneficial ownership by PHC (%)				15.00%
Term Loan Facility
Aggregate principal amount							35,000			$ 35,000		$ 35,000	$ 25,000
Tranche 2 Loan
Amount received from loan funding	$ 10,000
PHC Notes
Interest rate (as a percent)																	8.00%	9.50%
Aggregate principal amount																$ 35,000		$ 35,000
Common stock, par value per share (in dollars per share)																		$ 0.001
Conversion price (in dollars per share)																		$ 0.53
2025 Notes
Interest rate (as a percent)		5.25%
Aggregate principal amount		$ 30,800					$ 20,399		$ 6,800	$ 20,399		20,399	20,399						$ 82,000
Converted debt amount		$ 7,500
Debt converted, Shares issued		35,100,000							5,152,259
Conversion price (in dollars per share)																			$ 1.32
Ascensia \| PHC Notes
Aggregate principal amount				$ 35,000														$ 35,000
PHC Exchange Warrant
Number of shares of common stock called by warrant				68,525,311
Exercise price of warrant (in dollars per share)				$ 0.001
PHC Purchase Warrant
Number of shares of common stock called by warrant				15,425,750
Exercise price of warrant (in dollars per share)				$ 0.001
Purchase price of warrant (in dollars per share)				$ 0.97
Proceeds from issuance of warrants				$ 15,000
Convertible Preferred Equity
Amount of possible additional debt principal amount																		$ 15,000
Hercules \| Term Loan Facility
Maximum amount available under facility															$ 50,000
Interest rate (as a percent)															9.90%
Hercules \| Term Loan Facility \| Maximum
Maximum amount available under facility															$ 50,000
Hercules \| Tranche 1 Loan
Maximum amount available under facility															25,000
Hercules \| Tranche 2 Loan
Maximum amount available under facility															10,000
Amount received from loan funding	$ 10,000
Hercules \| Tranche 3 Loan
Maximum amount available under facility															$ 15,000
Open Market Sale Agreement
Proceeds from issuance of stock													$ 7,400
Shares issued (in shares)													9,944,663
Open Market Sale Agreement \| Jefferies LLC
Issuance of common stock, net of issuance costs			$ 106,600										$ 7,400
Shares issued (in shares)													9,944,663
Open Market Sale Agreement \| Jefferies LLC \| Maximum
Issuance of common stock, net of issuance costs						$ 150,000
Percentage of commission on proceeds from common stock						3.00%
Equity Distribution Agreement \| Goldman Sachs & Co. LLC
Proceeds from issuance of stock												$ 300
Shares issued (in shares)												728,291
Equity Distribution Agreement \| Goldman Sachs & Co. LLC \| Maximum
Issuance of common stock, net of issuance costs					$ 106,600
Percentage of commission on proceeds from common stock					3.00%

Summary of Significant Accounting Policies - Segment Information (Details)	6 Months Ended
	Jun. 30, 2024 segment
Segment Information
Number of operating segments	1

Revenue Recognition - Revenue by Geographic Region (Details) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2024 USD ($)	Jun. 30, 2023 USD ($)	Jun. 30, 2024 USD ($) item	Jun. 30, 2023 USD ($)
Revenue, net:
Revenue, net	$ 4,865	$ 4,126	$ 9,912	$ 8,263
Percent of total revenue	100.00%	100.00%	100.00%	100.00%
Number of geographical markets \| item			2
United States
Revenue, net:
Revenue, net	$ 3,030	$ 1,793	$ 6,706	$ 3,955
Percent of total revenue	62.30%	43.50%	67.70%	47.90%
Outside of the United States
Revenue, net:
Revenue, net	$ 1,835	$ 2,333	$ 3,206	$ 4,308
Percent of total revenue	37.70%	56.50%	32.30%	52.10%

Revenue Recognition - Contract Assets (Details) - USD ($) $ in Millions	Jun. 30, 2024	Dec. 31, 2023
Revenue Recognition
Unbilled receivables from customers	$ 0.9	$ 1.5

Revenue Recognition - Concentration of Revenue and Customers (Details) - Customer concentration risk - Ascensia - customer	3 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Concentration Risk [Line Items]
Number of customers	1	1
Revenue
Concentration Risk [Line Items]
Concentration Risk, Percentage	84.00%	89.00%

Net Loss per Share - Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023	Dec. 31, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Net loss	$ (20,287)	$ (20,423)	$ (39,164)	$ (19,099)	$ (60,400)	$ 142,100
Dilutive Net Loss	$ (20,287)	$ (20,423)	$ (39,164)	$ (19,099)
Net loss per share
Basic	$ (0.03)	$ (0.04)	$ (0.06)	$ (0.04)
Diluted	$ (0.03)	$ (0.04)	$ (0.06)	$ (0.04)
Basic weighted average shares outstanding	616,585,664	567,125,022	615,587,105	532,499,776
Dilutive potential common stock outstanding
Diluted weighted average shares outstanding	616,585,664	567,125,022	615,587,105	532,499,776
Anti-dilutive shares outstanding	92,482,985	102,274,485	92,482,985	102,274,485
Stock-based awards
Dilutive potential common stock outstanding
Anti-dilutive shares outstanding	44,689,681	31,785,464	44,689,681	31,785,464
2025 Notes
Dilutive potential common stock outstanding
Anti-dilutive shares outstanding	15,813,176	39,689,142	15,813,176	39,689,142
Energy Capital Preferred Shares
Dilutive potential common stock outstanding
Anti-dilutive shares outstanding	30,372,058	30,372,058	30,372,058	30,372,058
Warrants
Dilutive potential common stock outstanding
Anti-dilutive shares outstanding	1,608,070	427,821	1,608,070	427,821
Number of shares called by warrants	83,951,061	83,951,061	83,951,061	83,951,061

Marketable Securities - AFS Debt Securities (Details) - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Marketable securities available for sale, consisting of debt securities:
Amortized Cost	$ 49,781	$ 33,758
Gross Unrealized Gains	1	1
Gross Unrealized Losses	(8)	(12)
Estimated Market Value	49,774	33,747
Commercial paper
Marketable securities available for sale, consisting of debt securities:
Amortized Cost	11,783	7,598
Gross Unrealized Losses	(8)
Estimated Market Value	11,775	7,598
Corporate debt securities
Marketable securities available for sale, consisting of debt securities:
Amortized Cost		7,980
Gross Unrealized Gains		1
Estimated Market Value		7,981
Government and agency securities
Marketable securities available for sale, consisting of debt securities:
Amortized Cost	37,998	18,180
Gross Unrealized Gains	1
Gross Unrealized Losses		(12)
Estimated Market Value	$ 37,999	$ 18,168

Marketable Securities - AFS Debt Securities - Maturities (Details) - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Net Carrying Amount
2024 (remaining six months)	$ 49,781
Total	49,781	$ 33,758
Fair Value
2024 (remaining six months)	49,774
Total	$ 49,774

Inventory, net (Details) - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023	Jun. 30, 2023
Finished goods	$ 1,209	$ 2,160
Work-in-process	4,766	5,332
Raw materials	1,240	1,284
Total	7,215	$ 8,776
Cost of sales
Inventory adjustments included in cost of sales
Inventory adjustments	$ 100		$ 100

Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Prepaid Expenses and Other Current Assets
Contract manufacturing	$ 3,571	$ 4,244
Tax credits receivable	1,793	1,793
Insurance	487	73
Clinical and Preclinical	304	343
IT and software	125	242
Rent and utilities	99	122
Sales and Marketing	70	20
Investor Relations	39
Research and development	14	95
Interest receivable		272
Accounting and Audit		61
Other		1
Total prepaid expenses and other current assets	$ 6,502	$ 7,266

Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Accrued Expenses and Other Current Liabilities
Research and development	$ 4,515	$ 3,846
Compensation and benefits	2,771	4,799
Professional and administrative services	2,208	673
Contract manufacturing	1,024	1,457
Interest on notes payable	780	704
Sales and marketing services	577	301
Product warranty and replacement obligations	459	514
Accrued construction and renovation costs	399
Operating lease	$ 398	$ 368
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Total accrued expenses and other current liabilities	Total accrued expenses and other current liabilities
Other	$ 11	$ 27
Total accrued expenses and other current liabilities	$ 13,142	$ 12,689

Leases (Details) $ in Thousands	1 Months Ended	6 Months Ended
Leases (Details) $ in Thousands	May 31, 2023 USD ($)	Jun. 30, 2024 USD ($) ft² item	Jun. 30, 2023 USD ($)	Dec. 31, 2023 USD ($)
Lessee, Lease, Description [Line Items]
Operating lease ROU assets		$ 5,012		$ 5,180
Operating Lease, Liability		6,408		$ 6,582
Operating lease expense		$ 400	$ 400
Research and Office Space
Lessee, Lease, Description [Line Items]
Leased space, in square feet \| ft²		33,000
Tenant improvement allowance	$ 1,300
Number of renewal terms \| item		1
Renewal term of lease		5 years
Option to renew lease		true
Operating lease ROU assets	2,500
Operating Lease, Liability	$ 3,800

Leases - Assets and liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Operating Lease Assets and Liabilities
Operating lease ROU assets	$ 5,012	$ 5,180
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List]	Deposits and Other Assets, Noncurrent	Deposits and Other Assets, Noncurrent
Current operating lease liabilities	$ 398	$ 368
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Accrued Liabilities and Other Liabilities, Current	Accrued Liabilities and Other Liabilities, Current
Non-current operating lease liabilities	$ 6,010	$ 6,214
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List]	Other Liabilities, Noncurrent	Other Liabilities, Noncurrent
Total operating lease liabilities	$ 6,408	$ 6,582
Maturity of undiscounted payments
2024 (remaining 6 months)	461
2025	939
2026	967
2027	996
2028	1,026
Thereafter	4,908
Total	9,297
Less: Present value adjustment	(2,889)
Present value of lease liabilities	$ 6,408	$ 6,582
Remaining lease term (years)	8 years 10 months 24 days
Discount rate	8.50%

Product Warranty Obligations (Details) - USD ($) $ in Thousands	6 Months Ended	12 Months Ended
	Jun. 30, 2024	Dec. 31, 2023
Product Warranty Obligations
Warranty term	1 year
Warranty reserve	$ 459	$ 514
Reconciliation of the change in estimated warranty liabilities
Balance at beginning of the period	514	781
Provision for warranties during the period	125	242
Settlements made during the period	(180)	(509)
Balance at end of the period	$ 459	$ 514

Notes Payable, Preferred Stock and Stock Purchase Warrants - Term Loans (Details) - USD ($) $ / shares in Units, $ in Thousands	Jan. 02, 2024	Sep. 08, 2023	Jun. 30, 2024	Mar. 31, 2023	Mar. 13, 2023
PHC Exchange Warrant
Debt Instrument [Line Items]
Number of shares called by warrants					68,525,311
Exercise price of warrant (in dollars per share)					$ 0.001
Warrants fair value				$ 48,600
PHC Purchase Warrant
Debt Instrument [Line Items]
Exercise price of warrant (in dollars per share)					$ 0.001
Term Loan Facility Warrants \| Hercules
Debt Instrument [Line Items]
Warrants term (in years)		7 years
Funded loan amount on exercise of warrants for shares (as percentage)		2.00%
Volume-weighted average price considered for exercise of warrants (in days)		3 days
Term Loan Stock Purchase Warrants - Tranche 1 \| Hercules
Debt Instrument [Line Items]
Number of shares called by warrants		832,362
Exercise price of warrant (in dollars per share)		$ 0.6007
Debt fair value		$ 25,000
Warrants fair value		400
Term Loan Stock Purchase Warrants - Tranche 2
Debt Instrument [Line Items]
Number of shares called by warrants	347,887
Exercise price of warrant (in dollars per share)	$ 0.5749
Term Loan Facility
Debt Instrument [Line Items]
Effective interest rate (as percentage)			9.90%
Term Loan Facility \| Hercules
Debt Instrument [Line Items]
Maximum amount available under facility		$ 50,000
Interest rate (as a percent)		9.90%
Prepayment fee on principal amount if paid within one year (as percentage)		3.00%
Prepayment fee on principal amount if prepayment occurs during the second year (as percentage)		2.00%
Prepayment fee on principal amount if prepayment occurs in more than two years (as percentage)		1.00%
Payment of facility fee on prepayment of borrowings		$ 375
Additional facility charges (as percentage)		0.50%
Final prepayment fee (as a percent)		6.95%
Minimum cash covenant percentage		30.00%
Added default interest rate (as percentage)		4.00%
Debt issuance costs and discounts		$ 1,100
Effective interest rate (as percentage)		12.92%
Term Loan Facility \| Hercules \| Prime rate
Debt Instrument [Line Items]
Spread for interest rate (as percentage)		1.40%
Tranche 1 Loan \| Hercules
Debt Instrument [Line Items]
Maximum amount available under facility		$ 25,000
Tranche 2 Loan
Debt Instrument [Line Items]
Amount received from loan funding	$ 10,000
Tranche 2 Loan \| Hercules
Debt Instrument [Line Items]
Maximum amount available under facility		10,000
Amount received from loan funding	$ 10,000
Tranche 3 Loan \| Hercules
Debt Instrument [Line Items]
Maximum amount available under facility		$ 15,000

Notes Payable, Preferred Stock and Stock Purchase Warrants - Convertible Preferred Stock and Warrants (Details) - USD ($)			3 Months Ended	12 Months Ended
	Mar. 13, 2023	Aug. 09, 2020	Mar. 31, 2023	Dec. 31, 2023
PHC Notes
Debt Instrument [Line Items]
Original debt conversion amount		$ 0
Gain (Loss) on extinguishment of debt			$ 48,600,000	$ 100,000
PHC Purchase Warrant
Debt Instrument [Line Items]
Exercise price of warrant (in dollars per share)	$ 0.001
PHC Purchase Warrant \| PHC
Debt Instrument [Line Items]
Warrants to purchase shares	15,425,750
Exercise price of warrant (in dollars per share)	$ 0.001
Aggregate gross proceeds	$ 15,000,000.0
Warrants fair value	14,300,000
Additional paid-in-capital	$ 700,000
PHC Exchange Warrant
Debt Instrument [Line Items]
Warrants to purchase shares	68,525,311
Exercise price of warrant (in dollars per share)	$ 0.001
Warrants fair value			$ 48,600,000
Interest payments	$ 675,000
PHC Exchange Warrant \| PHC Notes
Debt Instrument [Line Items]
Original debt conversion amount	$ 35,000,000.0

Notes Payable, Preferred Stock and Stock Purchase Warrants - Convertible Notes (Details)				1 Months Ended	3 Months Ended		5 Months Ended	6 Months Ended	12 Months Ended
	Aug. 10, 2023 USD ($) shares	Jan. 31, 2023 USD ($)	Aug. 09, 2020 USD ($) $ / shares shares	Jul. 31, 2019 USD ($) $ / shares	Mar. 31, 2023 USD ($)	Mar. 31, 2018 USD ($) $ / shares	Jan. 27, 2021 USD ($) shares	Jun. 30, 2023 USD ($)	Dec. 31, 2023 USD ($) $ / shares	Jun. 30, 2024 USD ($) $ / shares	Apr. 30, 2022	Apr. 21, 2020 USD ($)
Long term debt
Carrying Amount									$ 41,195,000	$ 34,202,000
Derivative liabilities									$ 102,000
Common stock, par value per share (in dollars per share) \| $ / shares									$ 0.001	$ 0.001
PHC Notes
Long term debt
Principal amount			$ 35,000,000.0		$ 35,000,000.0
Conversion rate (per $1,000 of principal)			1,901.7956
Amount of principal which is converted to shares			$ 1,000
Conversion price (in dollars per share) \| $ / shares			$ 0.53
Gain (Loss) on extinguishment of debt					48,600,000				$ 100,000
Carrying Amount					25,400,000
Effective interest rate (as percentage)			29.19%					8.00%
Financing fee shares issued \| shares			2,941,176
Common stock, par value per share (in dollars per share) \| $ / shares			$ 0.001
Debt Discount Of Financing Fee Shares			$ 1,500,000
Interest rate (as a percent)			9.50%								8.00%
Value of shares issued on conversion			$ 15,000,000.0
Fair value of the embedded conversion option			25,800,000		0
Issuance costs incurred			2,900,000
Debt issuance costs and discounts			1,400,000
Original debt conversion amount			$ 0
Interest Payable					23,200,000
Net gain on exchange of debt instrument								$ 18,800,000
PHC Notes \| Debt Redemption on or After October 31, 2022
Long term debt
Threshold percentage of stock trigger			275.00%
Notice period			10 days
PHC Notes \| Debt Redemption on or After October 31, 2023
Long term debt
Notice period			10 days
PHC Notes \| Debt Redemption Six Months Prior to Maturity Date
Long term debt
Call premium percentage			130.00%
PHC Notes \| Debt Redemption Within Six Months of Maturity Date
Long term debt
Call premium percentage			125.00%
PHC Notes \| Other income (expenses)
Long term debt
Change in fair value of embedded derivative					$ 44,200,000
2025 Notes
Long term debt
Principal amount	$ 30,800,000			$ 82,000,000.0			$ 6,800,000		20,399,000	$ 20,399,000
Conversion rate (per $1,000 of principal)				757.5758
Amount of principal which is converted to shares				$ 1,000
Conversion price (in dollars per share) \| $ / shares				$ 1.32
Debt converted, Shares issued \| shares	35,100,000						5,152,259
Gain (Loss) on extinguishment of debt	$ (4,600,000)						$ 3,200,000
Converted debt amount	7,500,000
Carrying Amount	$ 20,400,000								17,257,000	18,642,000
Derivative liabilities									100,000	$ 0.0
Effective interest rate (as percentage)	15.54%							5.25%		5.25%
Interest rate (as a percent)	5.25%
Issuance costs incurred									$ 52,000	$ 29,000
2025 Notes \| Exchange Agreement with Highbridge
Long term debt
Principal amount												$ 24,000,000.0
2023 Notes
Long term debt
Principal amount						$ 53,000,000.0
Conversion rate (per $1,000 of principal)						294.1176
Amount of principal which is converted to shares						$ 1,000
Conversion price (in dollars per share) \| $ / shares						$ 3.40
Gain (Loss) on extinguishment of debt		$ 20,000.00
Derivative liabilities						$ 17,300,000
Effective interest rate (as percentage)								5.25%
Repurchase price as a percent of principal amount						100.00%
Transaction costs						$ 2,200,000
Amortization percent						9.30%
Repurchase amount						$ 37,000,000.0

Notes Payable, Preferred Stock and Stock Purchase Warrants - Carrying Amount of Notes Payable (Details) - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023	Aug. 10, 2023	Jan. 27, 2021	Jul. 31, 2019
Debt Instrument [Line Items]
Carrying Amount	$ 34,202	$ 41,195
2025 Notes
Debt Instrument [Line Items]
Principal	20,399	20,399	$ 30,800	$ 6,800	$ 82,000
Debt (Discount) Premium	(1,728)	(3,090)
Issuance Costs	(29)	(52)
Carrying Amount	18,642	17,257	$ 20,400
Term Loan Facility
Debt Instrument [Line Items]
Principal	35,000	25,000
Debt (Discount) Premium	(505)	(733)
Issuance Costs	(293)	(329)
Carrying Amount	$ 34,202	$ 23,938

Notes Payable, Preferred Stock and Stock Purchase Warrants - Interest expense (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Aug. 10, 2023	Aug. 09, 2020
Long term debt
Interest	$ 2,284	$ 2,113
Debt Discount and Fees	1,789	4,708
Issuance Costs	60	141
Total Interest Expense	$ 4,133	$ 6,962
2023 Notes
Long term debt
Effective interest rate (as percentage)		5.25%
Interest		$ 69
Debt Discount and Fees		120
Total Interest Expense		$ 189
2025 Notes
Long term debt
Effective interest rate (as percentage)	5.25%	5.25%	15.54%
Interest	$ 535	$ 1,344
Debt Discount and Fees	1,362	3,146
Issuance Costs	23	53
Total Interest Expense	$ 1,920	$ 4,543
PHC Notes
Long term debt
Effective interest rate (as percentage)		8.00%		29.19%
Interest		$ 700
Debt Discount and Fees		1,442
Issuance Costs		88
Total Interest Expense		$ 2,230
Term Loan Facility
Long term debt
Effective interest rate (as percentage)	9.90%
Interest	$ 1,749
Debt Discount and Fees	427
Issuance Costs	37
Total Interest Expense	$ 2,213

Notes Payable, Preferred Stock and Stock Purchase Warrants - Scheduled Maturities (Details) $ in Thousands	Jun. 30, 2024 USD ($)
Scheduled maturities
2025	$ 20,399
2026	12,996
2027	24,437
Total	$ 57,832

Stockholders' Equity (Details) - USD ($) $ in Thousands		1 Months Ended		3 Months Ended		6 Months Ended	11 Months Ended	12 Months Ended
Stockholders' Equity (Details) - USD ($) $ in Thousands	Aug. 07, 2023	Aug. 31, 2023	Nov. 30, 2021	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2023	Jun. 30, 2024	Dec. 31, 2023
Class of Stock [Line Items]
Proceeds from offering				$ 1	$ 7,376	$ 7,376
Open Market Sale Agreement
Class of Stock [Line Items]
Proceeds from issuance of common stock, net								$ 7,400
Shares issued (in shares)								9,944,663
Open Market Sale Agreement \| Jefferies LLC
Class of Stock [Line Items]
Proceeds from offering	$ 106,600							$ 7,400
Shares issued (in shares)								9,944,663
Open Market Sale Agreement \| Maximum \| Jefferies LLC
Class of Stock [Line Items]
Proceeds from offering			$ 150,000
Percentage of commission on proceeds from common stock			3.00%
Equity Distribution Agreement \| Goldman Sachs & Co. LLC
Class of Stock [Line Items]
Proceeds from issuance of common stock, net							$ 300
Shares issued (in shares)							728,291
Equity Distribution Agreement \| Maximum \| Goldman Sachs & Co. LLC
Class of Stock [Line Items]
Proceeds from offering		$ 106,600
Percentage of commission on proceeds from common stock		3.00%

Stock-Based Compensation (Details)	1 Months Ended		6 Months Ended
Stock-Based Compensation (Details)	Feb. 29, 2016 shares	Dec. 31, 2015	Jun. 30, 2024 item shares	Jan. 30, 2023 shares	May 30, 2019 shares
2015 Equity Incentive Plan
Stock-based compensation
Expiration period		10 years
Automatic annual increase in shares authorized, percent of common stock outstanding			3.50%
Shares available for grant			27,844,978
Inducement Plan
Stock-based compensation
Total shares that may be issued					1,800,000
Shares available for grant			317,094
Commercial Equity Plan
Stock-based compensation
Total shares that may be issued				10,000,000
Shares available for grant			7,700,000
2016 Employee Stock Purchase Plan
Stock-based compensation
Total shares that may be issued	800,000		22,729,158
Automatic annual increase in shares authorized, percent of common stock outstanding	1.00%
Stock issued			199,066
Payroll deductions for ESPP participants (as a percent)			15.00%
Percentage on share price issued			85.00%
Offering period duration			6 months
Purchase periods \| item			2
1997 Stock Option Plan
Stock-based compensation
Total shares that may be issued			823,389

Fair Value Measurements - Recurring (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2024	Dec. 31, 2023
Fair Value Measurements
Cash and cash equivalents	$ 34,853	$ 75,709
Marketable securities	49,774	33,747
Derivative liabilities		102
2025 Notes
Fair Value Measurements
Derivative liabilities	0	100
Reconciliation of items measured at fair value on a recurring basis that used significant unobservable inputs (Level 3)
Balance at the beginning of the period	102
(Gain) Loss on change in fair value of derivatives	$ (102)
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Change in Unrealized Gain (Loss)
Recurring \| Embedded conversion option \| 2025 Notes
Fair Value Measurements
Derivative liabilities		102
Recurring \| Money market funds
Fair Value Measurements
Cash and cash equivalents	$ 33,901	72,953
Recurring \| Commercial paper
Fair Value Measurements
Marketable securities	11,775	7,598
Recurring \| Corporate debt securities
Fair Value Measurements
Marketable securities		7,982
Recurring \| Government and agency securities
Fair Value Measurements
Marketable securities	37,999	18,167
Recurring \| Level 1 \| Money market funds
Fair Value Measurements
Cash and cash equivalents	33,901	72,953
Recurring \| Level 1 \| Government and agency securities
Fair Value Measurements
Marketable securities	37,399	18,167
Recurring \| Level 2 \| Commercial paper
Fair Value Measurements
Marketable securities	$ 11,775	7,598
Recurring \| Level 2 \| Corporate debt securities
Fair Value Measurements
Marketable securities		7,982
Recurring \| Level 3 \| Embedded conversion option \| 2025 Notes
Fair Value Measurements
Derivative liabilities		$ 102

Fair Value Measurements - Valuation Assumptions (Details) - 2025 Notes - Recurring - Level 3	Jun. 30, 2024
Stock price volatility
Fair value valuation assumptions
Embedded Derivative Liability, Measurement Input	0.450
Probabilities of conversion provisions \| Minimum
Fair value valuation assumptions
Embedded Derivative Liability, Measurement Input	0.10
Probabilities of conversion provisions \| Maximum
Fair value valuation assumptions
Embedded Derivative Liability, Measurement Input	0.90
Credit spread
Fair value valuation assumptions
Embedded Derivative Liability, Measurement Input	0.143

Income Taxes - Tax Provision (Details) - USD ($)	6 Months Ended
Income Taxes - Tax Provision (Details) - USD ($)	Jun. 30, 2024	Jun. 30, 2023
Income Taxes
Income tax provision	$ 0	$ 0

Related Party Transactions (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023
Related Party Transaction [Line Items]
Revenue, primarily from a related party	$ 4,865	$ 4,126	$ 9,912	$ 8,263
Due to related parties	13,142		13,142		$ 12,689
Related Party
Related Party Transaction [Line Items]
Revenue, primarily from a related party	4,087	$ 3,689	8,545	7,513
Due from related party	3,075		3,075		3,724
Due to related parties	1,226		1,226		945
Ascensia \| Related Party
Related Party Transaction [Line Items]
Revenue, primarily from a related party			8,500	7,500
Expense to related party			50	$ 300
Due from related party	3,100		3,100		3,700
Due to related parties	$ 1,200		$ 1,200		$ 500