8-K

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): May 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 May 9, 2023, Senseonics Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 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 May 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.

ay
Date: May 9, 2023	SENSEONICS HOLDINGS, INC.
	By:	/s/ Rick Sullivan
	Name:	Rick Sullivan
	Title:	Chief Financial Officer

EX-99.1

Exhibit 99.1

SENSEONICS HOLDINGS, INC. REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS

GERMANTOWN, MD, May 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 March 31, 2023.

Recent Highlights & Accomplishments:

● Generated revenue of $4.1 million in the first quarter of 2023.

● Ascensia Diabetes Care, Senseonics’ global commercial partner, is expanding their U.S. salesforce to a planned nearly 50 professionals, compared to an average of approximately 20 during 2022.

● Initiated the enrollment of a pediatric cohort in the ENHANCE trial evaluating the 365-day sensor configuration.

● Strengthened the balance sheet through financings from PHC Holdings, which included PHC Holdings’ exchange of its $35 million senior secured convertible notes for equity and an additional $15 million equity investment.

“In the first quarter, we made progress in our initiatives to support global patient and provider adoption of Eversense,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We believe continuing to work to drive commercial awareness and access through the Ascensia collaboration, along with advancing our technology pipeline, will drive future growth and create durable shareholder value.”

First Quarter 2023 Results:

Total revenue for the first quarter of 2023 was $4.1 million compared to $2.5 million for the first quarter of 2022. U.S. revenue was $2.1 million in the first quarter of 2023 compared to $0.8 million in the prior year period, and revenue outside the U.S. was $2.0 million in the first quarter of 2023 compared to $1.7 million in the prior year period.

First quarter 2023 gross profit of $0.4 million decreased from $0.5 million in gross profit for the first quarter of 2022.

First quarter 2023 sales and marketing and general and administrative expenses decreased by $0.2 million year-over-year, to $7.7 million. The decrease was primarily the result of a reduction in spend related to personnel costs, general administrative costs and selling and marketing consulting services.

First quarter 2023 research and development expenses increased by $4.6 million year-over-year, to $12.4 million. The increase was due to investments for next generation technologies including clinical studies activities, personnel related costs due to the expansion of our research and development workforce, consulting, contract fabrication and other R&D support services.

Net income was $1.3 million, or $0.00 per share, in the first quarter of 2023 compared to a net income of $86.7 million, or $0.19 per share, in the first quarter of 2022. The change in net income was the result of accounting for the exchange of the PHC notes, embedded derivatives and fair value adjustments.

Cash, cash equivalents, short and long-term investments were $136.6 million and outstanding indebtedness was $51.8 million as of March 31, 2023.

2023 Financial Outlook

Senseonics reiterates the expectation for full year 2023 global net revenue to be in the range of $20 million to $24 million.

Conference Call and Webcast Information

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

888-317-6003 412-317-6061	http://www.senseonics.com and select the “Investor Relations”section
Live Teleconference Information: Dial in number: 888-317-6003 Entry Number: 7018265 International dial in: 412-317-6061	Live Webcast Information: Visithttp://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 adoption, statements regarding advancing development programs, 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 commercialization responsibilities to Ascensia Diabetes Care’s U.S. salesforce and its commercial initiatives, uncertainties inherent in collaborating with a new partner in 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 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

Exhibit 99.1

Senseonics Holdings, Inc.

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

(in thousands, except share and per share data)

	Three Months Ended
	March 31,
	2023		2022
Revenue, net	$	313	$	292
Revenue, net - related parties		3,824		2,189
Total revenue		4,137		2,481
Cost of sales		3,723		1,954
Gross profit		414		527
Expenses:
Research and development expenses		12,405		7,804
Selling, general and administrative expenses		7,718		7,883
Operating loss		(19,709)		(15,160)
Other income (expense), net:
Interest income		1,108		93
Gain on fair value adjustment of option		—		21,701
Exchange related gain, net		18,776		—
Interest expense		(4,652)		(4,494)
Gain on change in fair value of derivatives		5,778		84,569
Impairment cost, net		—		30
Other income (expense)		23		(21)
Total other income (expense), net		21,033		101,878
Net Income		1,324		86,718
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities		458		(625)
Total other comprehensive gain (loss)		458		(625)
Total comprehensive income	$	1,782	$	86,093
Basic net income per common share	$	0.00	$	0.19
Basic weighted-average shares outstanding		497,473,222		455,942,886
Diluted net income (loss) per common share	$	0.00	$	(0.03)
Diluted weighted-average shares outstanding		540,532,813		605,198,839

Senseonics Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

	March 31,		December 31,
	2023		2022
		(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	45,085	$	35,793
Short term investments, net		83,359		108,222
Accounts receivable, net		451		127
Accounts receivable, net - related parties		2,953		2,324
Inventory, net		8,195		7,306
Prepaid expenses and other current assets		6,293		7,428
Total current assets		146,336		161,200
Deposits and other assets		2,998		3,108
Long term investments, net		8,157		12,253
Property and equipment, net		1,042		1,112
Total assets	$	158,533	$	177,673
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable	$	646	$	419
Accrued expenses and other current liabilities		12,808		14,616
Accrued expenses and other current liabilities, related parties		823		837
Note payable, current portion, net		—		15,579
Derivative liability, current portion		—		20
Total current liabilities		14,277		31,471
Long-term debt and notes payables, net		37,479		56,383
Derivative liabilities		2,081		52,050
Other liabilities		2,576		2,689
Total liabilities		56,413		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 March 31, 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 March 31, 2023 and December 31, 2022; 479,780,414 shares and 479,637,138 shares issued and outstanding as of March 31, 2023 and December 31, 2022		480		480
Additional paid-in capital		871,746		806,488
Accumulated other comprehensive loss		(220)		(678)
Accumulated deficit		(807,542)		(808,866)
Total stockholders’ equity (deficit)		64,464		(2,576)
Total liabilities and stockholders’ equity (deficit)	$	158,533	$	177,673

XML

Document and Entity Information	May 09, 2023
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	May 09, 2023
Entity Registrant Name	SENSEONICS HOLDINGS, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-37717
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
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
Entity Central Index Key	0001616543
Amendment Flag	false