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, 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 May 9, 2019, Senseonics Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 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 May 9, 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:  May 9, 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 FIRST QUARTER 2019 FINANCIAL RESULTS

GERMANTOWN, MD, May 9, 2019 —Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the design, 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 March 31, 2019.  

RECENT HIGHLIGHTS & ACCOMPLISHMENTS:

· First quarter 2019 revenue of $3.4 million

· Launched Eversense Bridge Patient Access Program to expand Eversense access for patients across the U.S.

· Received positive coverage decision for Eversense from Techniker, the largest payor in Germany covering over 10 million lives

· Initiated Eversense CGM data integration with the Glooko platform to provide patients and providers insights and actions for diabetes management based on personal glucose profiles

“We are pleased with our progress this year, which is marked by growing interest and support of Eversense from users, prescribers and payors,” said Tim Goodnow, President and Chief Executive Officer of Senseonics. “We are seeing meaningful growth in both covered lives and new users through our European partners. In the U.S., the launch of the Eversense Bridge Patient Access Program is simplifying the reimbursement process for new patients and supporting their ability to act on the interest we see across patients and providers. It is also enabling additional opportunities to get in front of the largest national payors. Through constructive experiences with these payors, we believe that we will obtain additional positive coverage decisions in the future. We are looking forward to building on this momentum.”

FIRST QUARTER 2019 RESULTS:

Revenue was $3.4 million for the first quarter of 2019 including adjustments for the bridge program, compared to $2.9 million for the first quarter of 2018.

First quarter 2019 gross profit decreased by $2.9 million year-over year, to ($3.3) million. The decrease in gross profit was associated with one-time component obsolescence due to product upgrades and product expiry due to the timing of the extension of the company’s distribution agreement with Roche.

First quarter 2019 sales and marketing expenses increased $9.4 million year-over year, to $12.8 million. The increase in sales and marketing expenses was primarily driven by the build out of the U.S. salesforce.

First quarter 2019 research and development expenses decreased $1.0 million year-over-year, to $7.1 million. The decrease in research and development expenses was primarily driven by the completion of all activities associated with the U.S. PMA Panel meeting for Eversense.

First quarter 2019 general and administrative expenses increased $2.5 million, year-over-year, to $6.5 million. The increase in general and administrative expenses was primarily driven by an increase in compensation, legal and other administrative expenses associated with supporting operational growth.

Net loss was $29.4 million, or $0.17 per share, in the first quarter of 2019, compared to $22.3 million, or $0.16 per share, in the first quarter of 2018.

As of March 31, 2019, cash and cash equivalents were $103.7 million and outstanding indebtedness was $65.2 million.

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, May 9, 2019, to discuss these financial results and recent business developments. This conference call can be accessed live by telephone or through Senseonics’ website.

(877)344-7529	http://www.senseonics.comand select the “Investor Relations” section
Live Teleconference Information: Dial in number: 888-378-4398 Entry Number: 756769 International dial in: 786-789-4775	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 transformative glucose monitoring products designed to help people with diabetes confidently live their lives with ease. From its inception, Senseonics has been advancing the integration of novel, fluorescence sensor technology with smart wearable devices. The Eversense® CGM System received PMA approval from the FDA for up to 90 days of continuous use and is available in the United States. The Eversense® XL CGM System received CE mark for up to 180 days of continuous use and is available in Europe. For more information on Senseonics, please visit www.senseonics.com.

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 in the U.S. and Eversense XL in Europe, 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 March  31, 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)

	March 31,		December 31,
	2019		2018
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	103,675	$	136,793
Accounts receivable (primarily from a related party)		2,367		7,097
Inventory, net		14,370		10,231
Prepaid expenses and other current assets		4,698		3,985
Total current assets		125,110		158,106
Deposits and other assets		114		117
Property and equipment, net		2,046		1,750
Right of use asset, building		2,131		—
Total assets	$	129,401	$	159,973
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	3,274	$	4,407
Accrued expenses and other current liabilities		13,754		13,851
Right of use liability, building, current portion		431		—
Deferred revenue		—		628
Term Loans, current portion		10,000		10,000
Total current liabilities		27,459		28,886
Term Loans, net of discount and current portion		2,347		4,783
2023 Notes, net of discount		36,949		36,103
Derivative liability		15,019		17,091
Term Loans, accrued interest		1,892		1,764
Right of use liability, building, net of current portion		1,791		—
Other liabilities		—		85
Total liabilities		85,457		88,712
Stockholders’ equity:
Common stock, $0.001 par value per share; 450,000,000 shares authorized; 176,958,487 and 176,918,381 shares issued and outstanding as of March 31, 2019 and December 31, 2018		177		177
Additional paid-in capital		430,926		428,878
Accumulated deficit		(387,159)		(357,794)
Total stockholders' equity		43,944		71,261
Total liabilities and stockholders’ equity	$	129,401	$	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
	March 31,
	2019		2018
Revenue, primarily from a related party	$	3,423	$	2,946
Cost of sales		6,733		3,308
Gross profit		(3,310)		(362)
Expenses:
Sales and marketing expenses		12,834		3,441
Research and development expenses		7,108		8,113
General and administrative expenses		6,516		4,011
Operating loss		(29,768)		(15,927)
Other income (expense), net:
Interest income		627		184
Interest expense		(2,034)		(1,771)
Change in fair value of derivative liability		2,072		(4,847)
Other (expense) income		(262)		88
Total other income (expense), net		403		(6,346)
Net loss		(29,365)		(22,273)
Total comprehensive loss	$	(29,365)	$	(22,273)
Basic and diluted net loss per common share	$	(0.17)	$	(0.16)
Basic and diluted weighted-average shares outstanding		176,954,116		137,069,008