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): March 12, 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.☒

Item 2.02.Results of Operations and Financial Condition.

On March 12, 2019, Senseonics Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2018, 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 March 12, 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:  March 12, 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 FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS

GERMANTOWN, MD, March 12, 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 fourth quarter and full year ended December 31, 2018.

RECENT HIGHLIGHTS & ACCOMPLISHMENTS:

· Received positive reimbursement decisions for Eversense® from several payors with coverage reaching approximately 60 million lives in the U.S.

· Obtained Regulatory approval to expand Eversense certification to Nurse Practitioners and Physician Assistants, both in the U.S. and Europe

· Commenced the PROMISE 180-day sensor clinical study in the U.S.

· Submitted a PMA supplement to the FDA seeking to secure an insulin dosing claim for Eversense

· Extended Roche distribution agreement through January 2021 while expanding to an additional 17 countries, including Brazil, Russia, India and China

· Appointed Jon D. Isaacson as Chief Financial Officer and Dr. Francine Kaufman as Chief Medical Officer

“We are pleased with 2018 which was a milestone year for Senseonics highlighted by FDA approval of the Eversense system, the build out of our commercial organization, and continued penetration in Europe” said Tim Goodnow, President and Chief Executive Officer of Senseonics.  “We continue to learn and adapt from the launch of this highly innovative product and expect real-world experience to drive patient and clinician demand for Eversense. With additional coverage policy wins and raising awareness of the benefits of a long-term implantable CGM, we are confident we have the strategy and team in place to accelerate adoption and help more patients manage their diabetes.”

FOURTH QUARTER 2018 RESULTS:

Revenue was $7.2 million for the fourth quarter of 2018, compared to $2.9 million for the fourth quarter of 2017.

Fourth quarter 2018 sales and marketing expenses increased $7.9 million year-over year, to $10.3 million. The increase in sales and marketing expenses was primarily driven by an increase in compensation expenses associated with new hires supporting the commercial launch of Eversense in the U.S. and to support and expand the distribution of Eversense® XL in Europe.

Fourth quarter 2018 research and development expenses decreased $0.3 million year-over-year, to $8.1 million. The decrease in research and development expenses was primarily driven by the completion of all activities associated with the U.S. PMA approval, including preparation for the FDA panel held in the first quarter of 2018.  

Fourth quarter 2018 general and administrative expenses increased $1.5 million, year-over-year, to $5.3 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 $7.3 million, or $0.04 per share, in the fourth quarter of 2018, compared to $16.3 million, or $0.12 per share, in the fourth quarter of 2017. Fourth quarter 2018 net loss per share was based on 176.9 million weighted average shares outstanding, compared to 136.8 million weighted average shares outstanding in the fourth quarter of 2017.

FULL YEAR 2018 RESULTS:

Revenue for the year ended December 31, 2018 was $18.9 million, compared to $6.4 million in 2017.

Sales and marketing expenses for the year ended December 31, 2018 increased $20.8 million year-over year, to $27.7 million, compared to $6.9 million for 2017. The increase in sales and marketing expenses was primarily related to investments in additional headcount to support the U.S. commercial launch of Eversense and support of the expanding commercial efforts for Eversense XL in Europe. 

Research and development expenses for the year ended December 31, 2018 increased $1.2 million year-over-year, to $31.9 million, compared to $30.7 million for 2017. The increase in research and development expenses was primarily driven by product development expenses for future versions of Eversense and clinical trial costs related to the PMA approval of Eversense in the U.S.

General and administrative expenses for the year ended December 31, 2018 increased $4.5 million, year-over-year, to $19.8 million, compared to $15.3 million for 2017. The increase in general and administrative expenses was driven primarily by an increase in personnel-related expenses, increased facility expenses and increased legal and audit expenses.

Net loss was $94.0 million, or $0.60 per share, for the year ended December 31, 2018, compared to $59.1 million, or $0.51 per share, for 2017. Net loss per share for 2018 was based on 157.4 million weighted average shares outstanding, compared to 116.0 million weighted average shares outstanding for 2017. 

As of December 31, 2018, cash and cash equivalents were $136.8 million and outstanding indebtedness was $67.7 million.

2019 Financial Outlook

Management updates its projected revenue for full year 2019 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, March 12, 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: 866-519-2796 Entry Number: 117792 International dial in: 786-789-4771	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 expanded relationship with Roche, 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, the acceleration of the adoption 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, 2017, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, 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.

Unaudited Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

	December 31,
	2018		2017
Assets
Current assets:
Cash and cash equivalents	$	136,793	$	16,150
Marketable securities		—		20,300
Accounts receivable, primarily from a related party		7,097		3,382
Inventory, net		10,231		2,991
Prepaid expenses and other current assets		3,985		2,092
Total current assets		158,106		44,915
Deposits and other assets		117		176
Property and equipment, net		1,750		853
Total assets	$	159,973	$	45,944
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	4,407	$	7,712
Accrued expenses and other current liabilities		13,851		5,428
Deferred Revenue		628		—
Notes payable, current portion		10,000		10,000
Total current liabilities		28,886		23,140
Notes payable, net of discount		4,783		14,414
Convertible senior notes, net of discount		36,103		—
Derivative liability		17,091		—
Notes payable, accrued interest		1,764		1,054
Other liabilities		85		69
Total liabilities		88,712		38,677
Commitments and contingencies (Note 9)
Stockholders’ equity:
Common stock, $0.001 par value per share; 450,000,000 and 250,000,000 shares authorized as of December 31, 2018 and 2017; 176,918,381 and 136,882,735 shares issued and outstanding as of December 31, 2018 and 2017		177		137
Additional paid-in capital		428,878		270,953
Accumulated deficit		(357,794)		(263,823)
Total stockholders' equity		71,261		7,267
Total liabilities and stockholders’ equity	$	159,973	$	45,944

Senseonics Holdings, Inc.

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

(in thousands, except share and per share data)

	Years Ended
	December 31,
	2018		2017		2016
Revenue, primarily from a related party	$	18,913	$	6,373	$	332
Cost of sales		27,059		9,758		660
Gross profit		(8,146)		(3,385)		(328)
Expenses:
Sales and marketing expenses		27,730		6,857		2,736
Research and development expenses		31,863		30,735		26,347
General and administrative expenses		19,839		15,336		13,022
Operating loss		(87,578)		(56,313)		(42,433)
Other income (expense), net:
Interest income		2,001		135		80
Interest expense		(8,282)		(3,099)		(1,602)
Change in fair value of derivative liability		209		—		—
Other (expense) income		(321)		176		25
Total other expense, net		(6,393)		(2,788)		(1,497)
Net loss		(93,971)		(59,101)		(43,930)
Total comprehensive loss	$	(93,971)	$	(59,101)	$	(43,930)
Basic and diluted net loss per common share	$	(0.60)	$	(0.51)	$	(0.49)
Basic and diluted weighted-average shares outstanding		157,429,145		115,975,402		89,243,853