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): August 7, 2019

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))

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. ☒

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

Item 2.02.Results of Operations and Financial Condition.

On August 7, 2019, Senseonics Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2019, 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 August 7, 2019

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:  August 7, 2019	SENSEONICS HOLDINGS, INC.
	By:	/s/ Jon Isaacson
	Name:	Jon Isaacson
	Title:	Chief Financial Officer

EX-99.1

Exhibit 99.1

SENSEONICS HOLDINGS, INC. REPORTS SECOND QUARTER 2019 FINANCIAL RESULTS

GERMANTOWN, MD, August 7, 2019 —Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today reported financial results for the quarter ended June 30, 2019.

RECENT HIGHLIGHTS & ACCOMPLISHMENTS:

· Second quarter 2019 revenue of $4.6 million

· Received the non-adjunctive indication, or dosing claim, from the FDA for the Eversense CGM System

· Presented positive, 90-day real-world data at the 79th annual American Diabetes Association Scientific Sessions from the first 205 US commercial patients using Eversense which demonstrated 62% time-in-range, only 4% time in hypoglycemia (<70 mg/dL) and 84% median wear time of the transmitter

· Strengthened balance sheet by raising over $100 million gross proceeds through borrowings under a term loan agreement and the issuance of convertible debt and equity 

“We are encouraged by our progress commercializing the Eversense CGM System in the first half of the year as we increased utilization and our patient base, added incremental prescribers, received positive coverage decisions and initiated a positive dialogue with CMS (Centers for Medicare & Medicaid Services),” said Tim Goodnow, President and Chief Executive Officer of Senseonics. “We are confident we will continue to accelerate adoption based off of early patient experience and clinical performance combined with the attractiveness of the Bridge Patient Access program and a growing number of health care providers prescribing Eversense. We are also pleased to have strengthened our balance sheet meaningfully through a combination of instruments.”

SECOND QUARTER 2019 RESULTS:

Revenue was $4.6 million for the second quarter of 2019 including adjustments for the bridge program, compared to $3.6 million for the second quarter of 2018.

Second quarter 2019 gross profit decreased by $4.4 million year-over year, to ($4.6) million. The decrease in gross profit was primarily due to warranty expense and impairment charges associated with product design changes and manufacturing yield losses.

Second quarter 2019 sales and marketing expenses increased by $8.0 million year-over year, to $14.2 million. The increase in sales and marketing expenses was primarily driven by the build out of the U.S. salesforce and marketing expenses.

Second quarter 2019 research and development expenses increased by $2.2 million year-over-year, to $10.5 million. The increase in research and development expenses was primarily driven by expenses associated with the 180-day PROMISE clinical study.

Second quarter 2019 general and administrative expenses were essentially flat year-over-year at $5.4 million.

Net loss was $31.1 million, or $0.17 per share, in the second quarter of 2019, compared to $32.5 million, or $0.23 per share, in the second quarter of 2018.

As of June 30, 2019, cash and cash equivalents were $65.3 million and outstanding indebtedness was $62.7 million. In July 2019, Senseonics raised over $100 million in gross proceeds through a combination of borrowings under a term loan agreement and the issuance of convertible debt and equity.

2019 Financial Outlook

Revenue for full year 2019 is expected to be in the range of $25 to $30 million.

CONFERENCE CALL AND WEBCAST INFORMATION

Company management will host a conference call at 4:30 pm (Eastern Time) today, August 7, 2019, 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: 800-309-1256 Entry Number: 026232 International dial in: 786-789-4796 Live Webcast Information: Visit http://www.senseonics.comand 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. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' CGM systems, Eversense® and Eversense® XL, 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 statements about the potential additional positive coverage decisions, the potential commercialization of Eversense in additional markets, Senseonics’ projected revenue for full year 2019, the ongoing commercialization of Eversense, growing patient and clinician demand for Eversense, and the potential life-enhancing benefits Eversense offers people with diabetes, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” 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 in the development and regulatory approval processes, uncertainties inherent in the commercial launch and commercial expansion of the product,  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, 2018, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, 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

Lynn Lewis or Philip Taylor
Investor Relations
415-937-5406
Investors@senseonics.com

FINANCIAL STATEMENTS TO FOLLOW:

Senseonics Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

	June 30,		December 31,
	2019		2018
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	65,296	$	136,793
Accounts receivable		839		830
Accounts receivable - related parties		4,963		6,267
Inventory, net		16,787		10,231
Prepaid expenses and other current assets		6,091		3,985
Total current assets		93,976		158,106
Deposits and other assets		2,142		117
Property and equipment, net		2,278		1,750
Total assets	$	98,396	$	159,973
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	4,779	$	4,407
Accrued expenses and other current liabilities		16,922		13,851
Deferred revenue		—		628
Term Loans, accrued interest		2,002		—
Term Loans, current portion		9,901		10,000
Total current liabilities		33,604		28,886
Term Loans, net of discount and current portion		—		4,783
2023 Notes, net of discount		37,815		36,103
Derivative liability		10,130		17,091
Term Loans, accrued interest		—		1,764
Other liabilities		1,674		85
Total liabilities		83,223		88,712
Stockholders’ equity:
Common stock, $0.001 par value per share; 450,000,000 shares authorized; 177,031,842 and 176,918,381 shares issued and outstanding as of June 30, 2019 and December 31, 2018		177		177
Additional paid-in capital		433,229		428,878
Accumulated deficit		(418,233)		(357,794)
Total stockholders' equity		15,173		71,261
Total liabilities and stockholders’ equity	$	98,396	$	159,973

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,
	2019		2018		2019		2018
Revenue, net	$	1,475	$	553	$	2,718	$	931
Revenue, net - related parties		3,132		3,070		5,312		5,638
Cost of sales		9,160		3,839		15,893		7,147
Gross profit		(4,553)		(216)		(7,863)		(578)
Expenses:
Sales and marketing expenses		14,179		6,177		27,013		9,618
Research and development expenses		10,504		8,289		17,612		16,402
General and administrative expenses		5,417		5,382		11,933		9,393
Operating loss		(34,653)		(20,064)		(64,421)		(35,991)
Other income (expense), net:
Interest income		410		241		1,037		425
Interest expense		(1,965)		(2,236)		(3,999)		(4,007)
Change in fair value of derivative liability		4,889		(10,166)		6,961		(15,013)
Other income (expense)		245		(271)		(17)		(183)
Total other income (expense), net		3,579		(12,432)		3,982		(18,778)
Net loss		(31,074)		(32,496)		(60,439)		(54,769)
Total comprehensive loss	$	(31,074)	$	(32,496)	$	(60,439)	$	(54,769)
Basic and diluted net loss per common share	$	(0.17)	$	(0.23)	$	(0.34)	$	(0.40)
Basic and diluted weighted-average shares outstanding		177,012,497		138,767,873		176,983,467		137,923,135