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): November 11, 2020

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, $0.001 par value	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 7.01 Regulation FD Disclosure.

On November 11, 2020, members of management of Senseonics Holdings, Inc. (the “Company”) presented at the Credit Suisse Virtual Healthcare Conference, with a simultaneous live webcast of the presentation available on the Investor Relations section of the Company’s website. A copy of this slide presentation used during the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. 

The information set forth in this Item 7.01 and contained in the presentation furnished as Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company's filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01 Financial Statements and Exhibits. 

(d) Exhibits

Exhibit
Number	Exhibit Description
99.1	Company Presentation
104	Cover Page Interactive Data File (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.

Date: November 12, 2020	SENSEONICS HOLDINGS, INC.
	By:	/s/ Nick Tressler
	Name:	Nick Tressler
	Title:	Chief Financial Officer

EX-99.1

Exhibit 99.1

 SENSEONICS CONFIDENTIAL l NOVEMBER 2020 EVERSENSE®CGMSYSTEM The world’s first and only long-term CGM Tim Goodnow, PhD President and CEO Credit Suisse 29th Annual Virtual Healthcare Conference November 15, 2020

FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding managements plans, objectives and goals for future operations, including preliminary targets for future financial performance and cash projections of Senseonics Holdings, Inc. (the “Company”). Such forward-looking statements may be identified by the use of words such as “believe,” expect,” anticipate, “plan,” “estimate,” “project,” “target” or other similar expressions. These forward-looking statements are based on management’s current expectations and projections about future events, and such statements are, by their nature subject to uncertainties. Additionally, the preliminary projections of key financial targets and cash projections have been developed based on the model for the partnership with Ascensia, as reviewed and approved by the Senseonics Board of Directors. The Company expects to further refine such projections following the completion of the Company’s 2021 budgeting process and the development of more formal financial guidance that it intends to disclose along with its full year 2020 financial results in early 2021. This more formal guidance and actual performance could vary materially from the preliminary projections included in this presentation. The risks and uncertainties that may cause actual results, levels of activity, performance or achievements to differ materially from the Company’s current expectations include uncertainties related to the timing of the submission of the application for regulatory approval of the up to 180-day product and the up to 365-day product to the U.S. Federal Drug Administration (“FDA”), the receipt of approval from the FDA with respect to the up to 180-day and the up to 365-day product, and the timing of any such approvals; the timing of the initiation of Ascensia’s commercial activities, including the timing of U.S. commercial launch of the up to 180-day product and the up to 365-day product; the success of the transition of commercial activities to Ascensia, the risks attendant to the launch and commercialization of a new product in a competitive market, the availability of capital to fund the Company’s continued operations and execute its business plan, and such other factors that are more fully described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (“SEC”) on March 16, 2020, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed with the SEC on November 9, 2020, and its other filings with the SEC. Statements made in this presentation speak only as of the date of this presentation and should not be relied upon as of any subsequent date, and the Company assumes no obligation to update any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

EVERSENSE CGMSYSTEM The first and only long-term continuous glucose monitoring system ▪ Firs t and only CGM t hat las t s f or mont hs vs days ▪ Firs t and only implant able s ens or ▪ Firs t and only CGM t o ac hieve 8. 5% MARD ▪ Firs t and only t rans mit t er t hat is removable ▪ Firs t and only s ens or t hat is MRI c ompat ible ▪ Firs t and only s ys t em wit h on -body vibe alert s f or hypo and hyper warnings ▪ Firs t and only s ys t em wit h f res h, gent le -on s k in adhes ive pat c h ▪ Firs t and only devic e t hat does not require s elf - ins ert ions T h e r a p e u t i c i n d i c a t i o n f o r 1 8 yo a n d o l d e r . SENSORSMART TRANSMITTER MOBILE APP

 Proven technology with rich development history and regulatory approvals. 201620172018201920202021 Eversense® System (90-day) Eversense® XL System (180-day) Eversense® System (90-day) Expanded HCP MRI compatibility Therapeutic (non-adjunctive) indication. Android with Eversense NOW Remote Monitoring New Eversense 180 day New Eversense 180 day sensor anticipated approval certification to nurse practitioners (NPs) and physician assistants (PAs) Expanded HCP certification to include non physicians sensor PMA supplement submitted MRI compatibility New Eversense 180 day sensor anticipated submission Investigational Device Exemption (IDE) anticipated submission for 365 day sensor Android with Eversense NOW anticipated * Items in blue are based on a number of assumptions, please see slide "Cautionary Note Regarding Forward-looking Statements" for more information. New Eversense 180 day sensor anticipated approval

[LOGO]

 Focus on growth and expansion post start up with Ascensia commercial organization Next 12 months roadmap Eversense CGM (90D in US) Eversense XL CGM (180D in Europe) New Eversense 180D (US and Europe)* Start Up PhaseRamp Up Phase Beyond 12 months Focus Areas US • 10 Territories (12 field staff) • Independent Eversense Accounts • 350 HCPs (Authorized or Certified) • Commercial / Medicare coverage • New patient initiation EU • Select markets • New payer/tender contracts • Installed base protection • New patient initiation * Pending FDA Approval Focus Areas US • 25 Territories (37 field sales staff) • New and Existing Eversense Accounts/HCP’s • New product launch • DME and Global CPT Pathway • Incremental payer coverage policy EU • New product launch • New patient initiation • New tenders and payer contracts • Increased account penetration 2022 – 2025 WW Annual Commercial Investment: $30M to $80M per year US Dedicated Commercial Headcount: 80 - 160

 Estimated WW Net Revenue Range 2021-2025 (millions) Revenue Range 2025E$150 - $200M 2024E 2023E 2022E 2021E $100 - $120M $60 - $75M $30 - $40M $12 - $15M $-$50$100$150$200 * These projections are based on a number of key assumptions, the most significant of which are detailed in quarterly filing dated November 13, 2020. These projections are also subject to a number of material risks and uncertainties. See "Cautionary Note Regarding Forward-looking Statements" for more information. Accordingly, the projected financial information included on this slide should be read in conjunction with, and in light of, such additional information.

EVERSENSEPATIENT PROFILES Broad appeal of Eversense with new and former CGM users % of Eversense Users Target Patient Female 46% Male 54% Market Expansion 32% New to CGM Market Share 68% Dexcom 33% Medtronic 8.3% Profiles ❖Dissatisfied with Current CGM Age 902909910927 32% 19% Libre 16% A1c Avg Prior to Eversense ❖New to CGM with 206 388 Top Preferred Features of Existing Users 1. Accuracy Reason ❖Gateway <2020-3030-4040-5050-6060+ 2. Sensor Life 3. Implantable Convenience (Libre) SENSEONICS CONFIDENTIAL l NOVEMBER 20208

 Eversense users demonstrates high percent of time using device and time within range ... … and increased performance by age. US1 n = 1656 Europe Multi-Sensor Users2 n = 945 US1 Users by Age n = 1656 Median Wear Time (%) Single sensor Sensor Cycle 1 Sensor Cycle 2 Sensor Cycle 3 Sensor Cycle 4 % Time 70-180 mg/dL % Time < 70 mg/dL 69.0% ADA Clinical Consensus Recommendations: 70% Time in Range (%) 82.083.283.684.885.8 52.6% 59.2%65.8% ADA Clinical Consensus 18 - <2525 - <4545 - <65≥65 (N=140)(N=686)(N=704)(N=88) 62.064.563.263.764.0 4.6%4.8%4.2%3.4% 18-24yo25-44yo45-64yo>64yo 1 Katherine S Tweden, PhD. Real-World Data from U.S. Patients Using a Long-term Implantable Continuous Glucose Monitoring (CGM) System: Age Effect on Glycemic Control; Annual ADA Meeting Poster Presentation. June 2020 2 Katherine S Tweden, PhD; Dorothee Deiss, MD, Ravi Rastogi, Suresh Addaguduru, Francine Kaufman, MD Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor Over Multiple Sensor Insertion and Removal Cycles. Diabetes Technology & Therapeutics. 7 Nov 2019 9

 Commercial and Medicare coverage to 200 million covered lives since mid-2018 launch ~263M Lives are covered by the Top 25 US Health Insurers SENSEONICS CONFIDENTIAL l NOVEMBER 202010

 Therapeutic CGM Indication Part B Medical Services MAC Published Payment Rate Through December 30, 2020 CMS National Payment Rate Effective January 1, 2021 Providers bill Medicare directly with existing CPT codes to include cost of device and procedure time. Average Global Payment Rate Average Supply Cost 1 Average rate; actual rate depends on locality CPT 0446T (insertion) CPT 0448T (removal & reinsertion) $2,5471$2,147 $1,5791$1,279 SENSEONICS CONFIDENTIAL l NOVEMBER 202011

 SENSEONICS CONFIDENTIAL l NOVEMBER 2020 EVERSENSE PIPELINE 12

 Uniquely differentiated long-term technology solution with multiple product configuration ONE SENSOR TWO PRODUCTS ALL PATIENT SEGMENTS ✓NO sensor change for 1 year ✓NO daily calibration required ✓NO transmitter on body For Type 1 and Type 2 Patients On Demand and Continuous Monitoring No transmitter wear On body * Product vision subject to a number of assumptions and regulatory approval see “Cautionary Note Regarding Forward-looking Statements.”

 2021 2023 2024 Eversense 180 ▪ Gen 1 sensor with advanced chemistry ▪ 180D sensor life ▪ Continuous real-time with alerts ▪ iCGM / Interoperability Eversense 365 ▪ Gen 2 (Rome) sensor ▪ 365D sensor life with 1cal/wk ▪ Real-time CGM with alerts (with transmitter) with optional FGM point-in-time reading (no transmitter) Freedom System ▪ Rome 2 sensor with battery; 365D with 1cal/wk ▪ Real-time CGM with alerts (with transmitter) with optional FGM reading (no transmitter) ▪ Standalone FGM non-adjunctive, no transmitter Intensively-managed patients Intensively-managed patients +Insulin-using patients Intensively-managed patients +Insulin-using patients + Non-insulin patients Market population * Product vision subject to a number of assumptions and regulatory approval see “Cautionary Note Regarding Forward-looking Statements.” SmallLarge

2021 EVERSENSE 180 (NEW) Extended duration of current Eversense sensor with reduced calibration TECHNOLOGY Gen 1 sensor with advanced chemistry, updated algorithm USE CASE Twice a year sensor use for uninterrupted use for the year TARGET Intensively managed patients who want better control PMA Supplement Submitted Sept 30, 2020 SENSEONICS CONFIDENTIAL l NOVEMBER 202015

 One annual sensor for use as CGM for peace of mind and FGM for discretion Gen 2 Sensor TECHNOLOGY Gen 2 sensor (Rome); array based sensing USE CASE 365 Day with 1 cal/week Two products: CGM with transmitter and FGM without transmitter TARGET Intensively managed patients who want better control + All insulin-using patients

 Accuracy Performance Over 12 Month Period* Eversense vs SMBG Reference 20 Initial clinical study data demonstrates promising performance through 365 days. 17 14 1110.5 8 9.69.29.69.7 8.6 9.5 10.310.210.3 11.1111 MARD (%) 2 - Implant Duration (Month) *PROMISE Study with 365D Rome Sensor; n=40

2024 FREEDOM SYSTEM Autonomous sensor testing with data processing capacity CGM / FGM Gen 2 Sensor Enhanced TECHNOLOGY Enhanced Rome 2 sensor with integrated battery; updated algorithm USE CASE 365 Day with 1 cal/week Two unique products: 1) CGM with transmitter and FGM without transmitter 2) Standalone therapeutic FGM without transmitter TARGET Intensively managed patients who want better control + All insulin-using patients + Non-insulin patients SENSEONICS CONFIDENTIAL l NOVEMBER 202018

 SENSEONICS CONFIDENTIAL l NOVEMBER 2020 THANKYOU

XML

Cover	Nov. 11, 2020
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 11, 2020
Entity File Number	001-37717
Entity Registrant Name	SENSEONICS HOLDINGS, INC.
Entity Central Index Key	0001616543
Entity Tax Identification Number	47-1210911
Entity Incorporation, State or Country Code	DE
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, $0.001 par value
Trading Symbol	SENS
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	false