Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 9, 2023

SENSEONICS HOLDINGS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware		001-37717		47-1210911
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

20451 Seneca Meadows Parkway
Germantown, MD 20876-7005

(Address of Principal Executive Office) (Zip Code)

Registrant's telephone number, including area code: (301) 515-7260

Not Applicable

Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	SENS	NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ¨

Item 2.02. Results of Operations and Financial Condition.

On November 9, 2023, Senseonics Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2023, as well as information regarding a conference call to discuss these financial results and the Company’s recent corporate highlights and outlook. This press release has been furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by this reference.

The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.

Item 9.01. Financial Statements and Exhibits.

(d)Exhibits.

Exhibit
Number		Description
99.1		Press Release of Senseonics Holdings, Inc. dated November 9, 2023.

104		Cover Page Interactive Data (embedded within the Inline XBRL document).

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 hereunto duly authorized.

Date: November 9, 2023	SENSEONICS HOLDINGS, INC.

	By:	/s/ Rick Sullivan
	Name:	Rick Sullivan
	Title:	Chief Financial Officer

Exhibit 99.1

SENSEONICS HOLDINGS, INC. REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS

GERMANTOWN, MD, November 9, 2023 —Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter ended September 30, 2023.

Recent Highlights & Accomplishments:

Generated revenue of $6.1 million in the third quarter of 2023

Announced the last patient completion of the 365-day ENHANCE Pivotal Clinical Study adult cohort

Launched with our global commercial partner Ascensia Diabetes Care, a new direct to consumer U.S. advertising campaign, ‘The CGM for Real Life’ to increase awareness of Eversense’s unique benefits

Entered into a $50 million non-dilutive loan facility with Hercules Capital, Inc. and drew down an initial $25 million, further strengthening the balance sheet

“The third quarter was marked by milestones across our development programs, commercial collaboration with Ascensia, and continued progress in strengthening our balance sheet,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “Completing the adult cohort of the ENHANCE 365-day pivotal trial, launching a new advertising campaign and finalizing a new loan facility all help position us to advance our plans to grow adoption of Eversense, the world’s only long term CGM.”

Third Quarter 2023 Results:

Total revenue for the third quarter of 2023 was $6.1 million compared to $4.6 million for the third quarter of 2022. U.S. revenue was $3.9 million in the third quarter of 2023 compared to $1.9 million in the prior year period, and revenue outside the U.S. was $2.2 million in the third quarter of 2023 compared to $2.7 million in the prior year period.

Third quarter 2023 gross profit of $1.2 million increased from $0.8 million in gross profit for the third quarter of 2022. The increase in gross margin was primarily driven by an increase to revenue as volumes increased.

Third quarter 2023 sales and marketing and general and administrative expenses increased by $0.1 million year-over-year, to $7.4 million. The consistency was the result of efforts to manage other general and administrative costs across the organization.

Third quarter 2023 research and development expenses increased by $1.8 million year-over-year, to $12.8 million. The increase was primarily due to investments in our product pipeline for development and clinical trials of next generation technologies.

Net loss was $24.1 million, or $0.04 per share, in the third quarter of 2023 compared to a net loss of $60.4 million, or $0.13 per share, in the third quarter of 2022. Net income increased by $36.3 million due to the accounting for embedded derivatives, fair value adjustments and the exchange of a portion of the 2025 notes.

Cash, cash equivalents, short and long-term investments were $125.4 million and outstanding indebtedness was $45.8 million as of September 30, 2023.

2023 Financial Outlook

Senseonics expects full year 2023 global net revenue to be at the midpoint of the $20 million to $24 million range.

Conference Call and Webcast Information:

Company management will host a conference call at 4:30 pm (Eastern Time) today, November 9, 2023, to discuss these financial results and recent business developments. This conference call can be accessed live by telephone or through Senseonics' website.

Live Teleconference Information:

Dial in number: 888-317-6003

Entry Number: 1409312

International dial in: 412-317-6061

Live Webcast Information:

Visit http://www.senseonics.com and
select the "Investor Relations" section

A replay of the call can be accessed on Senseonics' website http://www.senseonics.com under "Investor Relations."

About Senseonics

Senseonics Holdings, Inc. ("Senseonics") is 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. Senseonics' CGM systems, Eversense®, Eversense® XL and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including the revenue projections under "2023 Financial Outlook," statements about the commercial launch of Eversense® E3, statements regarding increasing patient access and patient and provider adoption, statements regarding advancing development programs and the pipeline, statements regarding strengthening the Eversense® brand, and other statements containing the words "believe," “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the commercial launch of Eversense® E3 CGM system and commercial expansion of the Eversense product, uncertainties inherent in the expansion of Ascensia Diabetes Care’s U.S. salesforce and its commercial initiatives, uncertainties inherent in partnering with the Nurse Practitioner Group and that partner’s assumption of certain clinical and administrative activities, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration of new technology, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2022, the Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.

Investor Contact

Philip Taylor

Gilmartin Group

415-937-5406

Investors@senseonics.com

Senseonics Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

	September 30,			December 31,
	2023			2022
		(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	55,759		$	35,793
Short term investments, net		69,648			108,222
Accounts receivable, net		701			127
Accounts receivable, net - related parties		2,749			2,324
Inventory, net		9,726			7,306
Prepaid expenses and other current assets		7,557			7,428
Total current assets		146,140			161,200

Deposits and other assets		6,991			3,108
Long term investments, net		—			12,253
Property and equipment, net		934			1,112
Total assets	$	154,065		$	177,673
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable	$	2,669		$	419
Accrued expenses and other current liabilities		14,356			14,616
Accrued expenses and other current liabilities, related parties		277			837
Note payable, current portion, net		—			15,579
Derivative liability, current portion		—			20
Total current liabilities		17,302			31,471

Long-term debt and notes payables, net		40,485			56,383
Derivative liabilities		245			52,050
Other liabilities		6,312			2,689
Total liabilities		64,344			142,593

Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares and 12,000 shares issued and outstanding as of September 30, 2023 and December 31, 2022		37,656			37,656
Total temporary equity		37,656			37,656

Commitments and contingencies

Stockholders’ equity (deficit):
Common stock, $0.001 par value per share; 900,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 528,176,273 shares and 479,637,138 shares issued and outstanding as of September 30, 2023 and December 31, 2022		528			480
Additional paid-in capital		903,665			806,488
Accumulated other comprehensive loss		(59	)		(678	)
Accumulated deficit		(852,069	)		(808,866	)
Total stockholders’ equity (deficit)		52,065			(2,576	)
Total liabilities and stockholders’ equity	$	154,065		$	177,673

Senseonics Holdings, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except share and per share data)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2023			2022			2023			2022
Revenue, net	$	426		$	126		$	1,176		$	555
Revenue, net - related parties		5,671			4,496			13,184			10,263
Total revenue		6,097			4,622			14,360			10,818
Cost of sales		4,925			3,866			12,358			8,711
Gross profit		1,172			756			2,002			2,107

Expenses:
Research and development expenses		12,769			10,985			38,003			28,088
Selling, general and administrative expenses		7,425			7,340			22,598			23,785
Operating loss		(19,022	)		(17,569	)		(58,599	)		(49,766	)
Other income (expense), net:
Interest income		1,460			544			3,879			878
Gain (Loss) on fair value adjustment of option		—			(8,592	)		—			41,333
Exchange related gain (loss), net		(4,569	)		—			14,207			—
Interest expense		(2,425	)		(4,801	)		(9,388	)		(13,806	)
Gain (Loss) on change in fair value of derivatives		438			(28,948	)		6,505			152,169
Impairment cost, net		—			(984	)		—			(138	)
Other income (expense)		15			(41	)		194			(112	)
Total other (expense) income, net		(5,081	)		(42,822	)		15,397			180,324

Net (Loss) Income		(24,103	)		(60,391	)		(43,202	)		130,558
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities		61			(57	)		619			(973	)
Total other comprehensive gain (loss)		61			(57	)		619			(973	)
Total comprehensive (loss) income	$	(24,042	)	$	(60,448	)	$	(42,583	)	$	129,585

Basic net (loss) income per common share	$	(0.04	)	$	(0.13	)	$	(0.08	)	$	0.28
Basic weighted-average shares outstanding		592,452,262			472,475,747			552,703,546			464,244,736

Diluted net loss per common share	$	(0.04	)	$	(0.13	)	$	(0.08	)	$	(0.10	)
Diluted weighted-average shares outstanding		592,452,262			472,475,747			552,703,546			608,345,713

Cover	Nov. 09, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 09, 2023
Entity File Number	001-37717
Entity Registrant Name	SENSEONICS HOLDINGS, INC.
Entity Central Index Key	0001616543
Entity Tax Identification Number	47-1210911
Entity Incorporation, State or Country Code	DE
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
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	SENS
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	false