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 24, 2016

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))

Item 1.01 Entry into a Material Definitive Agreement

On May 24, 2016, Senseonics Incorporated, a wholly-owned subsidiary of Senseonics Holdings, Inc. (“we” or the “Company”) entered into an exclusive distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH (collectively, “Roche”), pursuant to which we granted Roche the exclusive right to market, sell and distribute our Eversense® continuous glucose monitoring system (“Eversense”) in Germany, Italy and the Netherlands. Pursuant to the agreement, Roche is obligated to purchase from us specified minimum volumes of Eversense components at pre-determined prices, which pricing is subject to renegotiation in certain circumstances. Under the terms of the agreement, Roche also has a right of first negotiation to exclusively negotiate a distribution arrangement in certain other countries within the European Union.

The distribution agreement has an initial term through May 31, 2018, which will be automatically extended through December 31, 2018 if Roche meets certain minimum purchase requirements under the agreement.  The distribution agreement is terminable by us under a number of circumstances, including if Roche materially breaches the terms of the agreement or fails to make certain minimum sales requirements. The agreement is terminable by Roche under a number of circumstances, including if we materially breach the agreement, if the distribution of Eversense is enjoined in the covered territories or in the case of certain intellectual property infringement claims. The agreement is terminable by either party if the other party becomes insolvent or subject to bankruptcy proceedings. The termination rights contained in the agreement are generally subject to advance notice requirements and an opportunity to cure. Further, Roche may terminate the agreement upon a change of control of our company with a transition period of the shorter of 18 months or the remaining term of the agreement.

The foregoing description of the distribution agreement is not complete and is qualified in its entirety by reference to the distribution agreement, which will be filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ending June 30, 2016.

Item 8.01 Other Events

On May 25, 2016, we issued a press release announcing the signing of the agreement with Roche described above.

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K, the contents of which are incorporated herein by reference. The information contained in this Current Report on Form 8-K speaks only as the date hereof. While we may elect to update the information in this Current Report on Form 8-K in the future, we disclaim any obligation to do so except to the extent required by applicable law.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

NumberDescription

99.1Press release of Senseonics Holdings, Inc. dated May 25, 2016.

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 26, 2016	SENSEONICS HOLDINGS, INC.
	By:	/s/ R. Don Elsey
	Name:	R. Don Elsey
	Title:	Chief Financial Officer

EX-99.1

Exhibit 99.1

………………………………………………………………………………………………………………………………………………………………………………

Senseonics Signs Exclusive Distribution Agreement with Roche

Roche Diabetes Care to Distribute the Eversense® CGM System in Germany, Italy and the Netherlands

Germantown, MD,  May 25, 2016  (BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE-MKT: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 announced it has signed an exclusive distribution agreement with Roche for the multi-country commercialization of Senseonics’ Eversense® Continuous Glucose Monitoring System.

Under the terms of the agreement, Senseonics has granted Roche the rights to promote, market, and sell the Eversense product line to diabetes clinics and patients in Germany, Italy and the Netherlands.

 “We are pleased to have Roche as our partner, and our distribution agreement represents an important step to enable expanded market access to our product,” said Tim Goodnow, CEO and President of Senseonics.  “Roche Diabetes Care is a trusted and highly respected market leader with a broad customer base and deep knowledge of the needs of people with diabetes, and is ideally suited to market and commercialize the Eversense CGM System. Together with Roche’s market presence, and extensive sales and support network, we aim to deliver a truly innovative continuous, long-term glucose monitoring solution to millions of people with diabetes.” 

Senseonics will retain responsibility for product development, regulatory approval, quality management, and manufacturing while Roche will be responsible for sales, marketing, customer support and distribution activities in Germany, Italy and the Netherlands. The distribution agreement may be expanded with additional products and territories in the future.

About Senseonics

Senseonics Holdings, Inc.is a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics’ first generation continuous glucose monitoring system, Eversense®, includes a small sensor, smart transmitter and mobile application. Based on fluorescence sensing technology, the sensor is designed to be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device. After insertion, the sensor is designed to continually and accurately measure glucose levels.  For more information on Senseonics, please visit www.senseonics.com.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com

About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 40 years, the Accu-Chek brand has been dedicated to enabling people with diabetes to live life as normally and actively as possible as well as to empowering healthcare professionals to manage their patients’ condition in an optimal way. Today, the Accu-Chek portfolio offers people with diabetes and healthcare professionals innovative products and impactful solutions for convenient, efficient and effective diabetes management, spanning from blood glucose monitoring through information management to insulin delivery. The Accu-Chek brand encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – contributing to an improved medical outcome.

For more information please visit www.accu-chek.com

All trademarks used or mentioned in this release are protected by law.

Forward Looking Statements

Certain statements contained in this press release, other than statements of fact that are independently verifiable at the date hereof, may constitute “forward-looking statements.” These forward-looking statements reflect Senseonics’ current views about its plans, intentions, expectations, strategies and prospects, including statements concerning the marketing and commercialization of Eversense in Germany, Italy and the Netherlands, which are based on the information currently available to Senseonics and on assumptions Senseonics has made. Although Senseonics believes that its plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, Senseonics can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond Senseonics’ control. Other risks and uncertainties are more fully described in the section entitled “Risk Factors” in Senseonics’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 19, 2016, its Quarterly Report on Form 10-Q filed with the SEC on May 12, 2016 and its other SEC filings. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause Senseonics’ expectations and beliefs to change. Unless otherwise required by applicable securities laws, Senseonics does not intend, nor do it undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise. While Senseonics may elect to update these forward-looking statements publicly at some point in the future, Senseonics specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.

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INVESTOR CONTACT

R. Don Elsey

Chief Financial Officer

301.556.1602

don.elsey@senseonics.com