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 9, 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 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 1.01. Entry into a Material Definitive Agreement

 

Ascensia Collaboration and Commercialization Agreement

 

On August 9, 2020, Senseonics, Incorporated, a wholly-owned subsidiary of Senseonics Holdings, Inc. (the “Company”) entered into a collaboration and commercialization agreement (the “Commercialization Agreement”) with Ascensia Diabetes Care Holdings AG (“Ascensia”), an affiliate of PHC Holdings Corporation (“PHC”), pursuant to which the Company has granted Ascensia the exclusive right to distribute the Company’s 90-day Eversense continuous glucose monitoring system (“Eversense”) and its 180-day Eversense continuous glucose monitoring system (“Eversense XL”) worldwide, with the following initial exceptions: (i) until January 31, 2021, the territory does not include countries covered by the Company’s current distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH, which are the Europe, Middle East and Asia, excluding Scandinavia and Israel, and 17 additional countries, including Brazil, Russia, India and China, as well as select markets in the Asia Pacific and Latin American regions; (ii) until September 13, 2021, the territory does not include countries covered by the Company’s distribution agreement with Rubin Medical, which are Sweden, Norway and Denmark; and (iii) until May 31, 2022, the territory does not include Israel. Pursuant to the Commercialization Agreement, Ascensia has agreed to begin actively marketing and selling Eversense and Eversense XL as follows: (i) for the United States, Eversense at a date to be agreed upon and Eversense XL upon receipt of marketing approval from the U.S. Food and Drug Administration; (ii) for Germany, Italy and Switzerland, Eversense XL beginning on February 1, 2021; and (iii) for Sweden, upon the later of the receipt of both marketing approval from the U.S. Food and Drug Administration and a new CE mark approval for a new Eversense XL version, and October 1, 2021.

 

Pursuant to the Commercialization Agreement, Ascensia will receive a portion of net revenue at specified tiered percentages ranging from the mid-teens to the mid-fortys based on levels of global net revenues. Ascensia is obligated to achieve specified minimum annual revenue targets and meet specified levels of sales and marketing spend. Ascensia will purchase Eversense and Eversense XL from the Company at prices to be negotiated based on parameters set forth in the Commercialization Agreement. Under the Commercialization Agreement, the Company will be responsible for product development and manufacturing, including regulatory submissions, approvals and registrations, and Ascensia will be responsible for sales, marketing, market access, patient and provider onboarding and customer support. The Company and Ascensia have agreed to establish a joint marketing committee with equal representation from each party.

 

The Commercialization Agreement has an initial term that will expire five years from the Product Availability Date (as defined in the Commercialization Agreement) for Eversense XL, which will be automatically extended for up to 3.5 additional years to provide Ascensia the ability to sell a 365-day Eversense product for two years if Ascensia would not have otherwise had such two-year opportunity at the time the initial term expires. The Commercialization Agreement is terminable by Ascensia under a number of circumstances, including if Eversense XL is not approved in the United States by August 31, 2021, or if the Company undergoes a change of control. The Commercialization Agreement is terminable by the Company if the Company undergoes a change of control and specified conditions related to achievement of net sales and compensation of Ascensia’s expenses are satisfied. The Commercialization Agreement is terminable by either party if the other party materially breaches its obligations under the Commercialization Agreement; provided, however, that if Ascensia is unable to achieve the specified minimum spending or revenue targets described above, then the Company will only have the right to covert Ascensia’s exclusive rights to nonexclusive rights. The Commercialization Agreement is also terminable by either party if the other party undergoes bankruptcy, dissolution or winding up. Certain of the termination rights contained in the Commercialization Agreement are subject to specified advance notice requirements and an opportunity to cure.

 

The foregoing description of the distribution agreement is not complete and is qualified in its entirety by reference to the Commercialization Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2020.

 

Issuance of Convertible Notes to PHC

 

Note Purchase Agreement

 

In connection with the Commercialization Agreement, on August 9, 2020, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”) with PHC, as the purchaser (together with the other purchasers from time to time party thereto, the “Note Purchasers”) and Alter Domus (US) LLC, as collateral agent.

 

 

 

 

Pursuant to the Note Purchase Agreement, the Company has agreed to borrow $35.0 million in aggregate principal through the issuance and sale of Senior Secured Convertible Notes (the “Notes”) on or prior to August 14, 2020 (the “Closing Date”). The Company has also agreed to issue 2,941,176 shares of its common stock, $0.001 par value per share (“Common Stock”) to PHC as a financing fee (the “Financing Fee Shares”) on the Closing Date. The Company intends to use $17.6 million of the proceeds from the issuance of the Notes to repay in full the Company’s First Lien Notes due October 2021, representing the payment of principal, interest and the prepayment premium on the First Lien Notes.

 

The Notes will be senior secured obligations of the Company and will be guaranteed on a senior secured basis by the Company’s wholly owned subsidiary, Senseonics, Incorporated. Interest at the annual rate of 9.5% will be payable semi-annually in cash or, at the Company’s option, payment in kind. The interest rate will decrease to 8.0% if the Company obtains approval for 180-day Eversense XL for marketing in the United States, subject to certain conditions. The maturity date for the Notes will be October 31, 2024 (the “Maturity Date”), provided that the Maturity Date will accelerate if the Company has not repaid the Company’s outstanding Second Lien Secured Notes (the “Second Lien Notes”) (other than an aggregate principal amount of up to $1.0 million) by 91 days prior to the maturity of the Second Lien Notes (as amended as described below in “—Amendment to Second Lien Note Agreement”). The obligations under the Notes are secured by substantially all of the Company’s and its subsidiary’s assets.

 

The Note Purchasers are entitled to convert the Notes to Common Stock at a conversion rate of 1,867.4136 shares per $1,000 principal amount of the Notes (including any interest added thereto as payment in kind), equivalent to a conversion price of approximately $0.54 per share, subject to specified anti-dilution adjustments, including adjustments for the Company’s issuance of equity securities on or prior to April 30, 2022 below the conversion price. In addition, following a notice of redemption or certain corporate events that occur prior to the maturity date, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its Notes in connection with such notice of redemption or corporate event. In certain circumstances, the Company will be required to pay cash in lieu of delivering make whole shares unless the Company obtains stockholder approval to issue such shares.

 

Subject to specified conditions, on or after October 31, 2022, the Notes are redeemable by the Company if the closing sale price of the Common Stock exceeds 275% of the conversion price for a specified period of time and subject to certain conditions upon 10 days prior written notice at a cash redemption price equal to the then outstanding principal amount (including any payment in kind interest which has been added to such amount), plus any accrued but unpaid interest. On or after October 31, 2023, the Notes are redeemable by the Company upon 10 days prior written notice at a cash redemption price equal to the then outstanding principal amount (including any payment in kind interest which has been added to such amount), plus any accrued but unpaid interest, plus a call premium of 130% if redeemed at least six months prior to the Maturity Date or a call premium of 125% if redeemed within six months of the Maturity Date.

 

The Note Purchase Agreement contains customary terms and covenants, including financial covenants, such as operating within an approved budget and achieving minimum revenue and liquidity targets, and negative covenants, such as limitations on indebtedness, liens, mergers, asset transfers, certain investing activities and other matters customarily restricted in such agreements. Most of these restrictions are subject to certain minimum thresholds and exceptions. The Note Purchase Agreement also contains customary events of default, after which the Notes be due and payable immediately, including defaults related to payment compliance, material inaccuracy of representations and warranties, covenant compliance, material adverse changes, bankruptcy and insolvency proceedings, cross-defaults to certain other agreements, judgments against the Company, change of control or delisting events, termination of any guaranty, governmental approvals, and lien priority.

 

Optional Future Sale and Issuance of Convertible Preferred Stock

 

The Company will also have the option to sell and issue PHC up to $15.0 million of convertible preferred stock (the “PHC Preferred Stock”) on or before December 31, 2022, contingent upon receipt of any stockholder approval required by the listing rules of the NYSE American and the Company obtaining approval for 180-day Eversense XL for marketing in the United States before such date. The purchase price per share of the PHC Preferred Stock would be $1,000.00 per share. Each share of PHC Preferred Stock would be convertible into a number of shares of Common Stock equal to $1,000 divided by the conversion price of $0.476 per share, subject to customary anti-dilution adjustments, including in the event of any stock split.

 

 

 

 

The Company and PHC have agreed that the PHC Preferred Stock will rank senior to the Common Stock and pari passu with the Series A Preferred Stock (as described below). Upon a liquidation, dissolution or winding up of the Company, each share of PHC Preferred Stock will be entitled to receive an amount per share equal to the greater of the purchase price paid and the amount that the holder would have been entitled to receive at such time if the PHC Preferred Stock were converted into Common Stock (the “Liquidation Amount”). The holders will also be entitled to participate in dividends declared or paid on the Common Stock on an as-converted basis. If the Company undergoes a change of control, each holder has the right to cause the Company to redeem any or all of the PHC Preferred Stock for cash consideration equal to the Liquidation Amount. In addition, the Company has agreed to redeem all of the PHC Preferred Stock on the ten year anniversary of the issuance date for cash consideration equal to the Liquidation Amount. Should the Company not fulfill this redemption obligation, PHC will have the right to nominate two additional members of the Company’s board of directors (the “Board”).

 

The holders of PHC Preferred Stock generally will be entitled to vote with the holders of the shares of Common Stock on all matters submitted for a vote of holders of shares of Common Stock (voting together with the holders of shares of Common Stock as one class) on an as-converted basis. Additionally, certain matters will require the approval of the majority of the outstanding PHC Preferred Stock, voting as a separate class, including (i) altering or changing adversely the powers, privileges, preferences or rights of the PHC Preferred Stock, or (ii) amendments, modifications, repeal or waiver of any provision of the Company’s certificate of incorporation, bylaws or of the certificate of designations that would adversely affect the rights, preferences, privileges or powers of the PHC Preferred Stock.

 

Registration Rights Agreement

 

In connection with the entry into the Note Purchase Agreement, the Company and PHC entered into a registration rights agreement (the “PHC RRA”), pursuant to which the Company has agreed to register the resale of the Financing Fee Shares and any shares issuable upon conversion of the Notes (the “PHC Registrable Securities”), pursuant to a registration statement on Form S-3 to be filed with the U.S. Securities and Exchange Commission (the “SEC”). Pursuant to the PHC RRA, the Company has agreed to file the Form S-3 no later than September 8, 2020, and to have it declared effective no later than 90 days thereafter.

 

The Company will pay additional interest on the Notes and the shares of Common Stock issued upon conversion of the Notes if the resale documents are not timely filed or made effective or if the resale documents are unavailable for periods in excess of those permitted. Such additional interest will accrue until the date prior to the day the default is cured at an annual rate of 0.5% of the aggregate principal amount of such Notes outstanding (or the principal amount of such Notes converted into Common Stock) for the first 90 days following the default and thereafter will increase by an annual rate of 0.5% during each subsequent 90-day period of the aggregate principal amount of such Notes outstanding up to an aggregate increase of 2.0%.

 

In addition, the holders of at least a majority of the PHC Registrable Securities have the right to demand that the Company to effect up to two underwritten public offerings or block trades of the PHC Registrable Securities, provided that the demand relates to all PHC Registrable Securities then outstanding or the aggregate market value of the PHC Registrable Securities to be included in such offering is at least $7.5 million. These registration rights are subject to specified conditions and limitations, including the right of a managing underwriter to limit the number of shares included in any such registration under specified circumstances.

 

Further, the holders of PHC Registrable Securities are entitled to certain piggyback registration rights if there is not otherwise an effective registration statement covering all of the PHC Registrable Securities or if Rule 144 is not available with respect to the PHC Registrable Securities. The PHC RRA contains customary other terms, conditions and other provisions.

 

Investor Rights Agreement

 

In connection with the entry into the Note Purchase Agreement, the Company and PHC entered into an investor rights agreement (the “PHC IRA”). Pursuant to the PHC IRA, for so long as PHC and its affiliates hold, in the aggregate on an as-converted basis, at least 15% of the Company’s Common Stock, PHC will have the right to designate two members (the “PHC Designees”) of the Board. If PHC and its affiliates hold, in the aggregate on an as-converted basis, at least 5% but less than 15% of the Company’s Common Stock, PHC will have the right to designate one member of the Board. PHC will designate and the Board will appoint the two initial PHC Designees no later than September 30, 2020.

 

 

 

 

In addition, pursuant to the PHC IRA, if the Company intends to issue new equity, equity-linked or debt securities or loans to any person, then the Note Purchaser has the right to participate in such transaction on a pro rata basis, subject to customary exceptions.

 

The foregoing descriptions in this Current Report on Form 8-K of the material terms of the Note Purchase Agreement, the PHC RRA and the PHC IRA do not purport to be complete descriptions of the rights and obligations of the parties thereunder and are qualified in their entirety to the Note Purchase Agreement, the PHC RRA and the PHC IRA, which the Company expects to file as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.

 

Amendment to Second Lien Note Agreement

 

On August 9, 2020, in connection with the entry into the Note Purchase Agreement with PHC, the Company entered into a First Amendment to Note Purchase and Exchange Agreement and Notes (the “Amendment”) with Highbridge Tactical Credit Master Fund, L.P. (“Highbridge”) and each other purchaser party thereto.

 

Pursuant to the Amendment, Highbridge agreed to the consummation of the other transactions described in this Current Report on Form 8-K and, effective as of the Closing Date, agreed to an extension of the maturity date for the Second Lien Notes to August 9, 2023. As amended by the Amendment, the holders of the Second Lien Notes will have the right to convert the aggregate principal of the Second Lien Notes (together with any applicable prepayment premium) to Common Stock at a price per share equal to 90% of the greater of (i) the daily volume weighted average of the price per share of the Common Stock, on the conversion date, or if the conversion date is not a trading date, the trading day immediately prior to the conversion date and (ii) $0.33 per share. This conversion option has a daily limit of $1,000,000 in aggregate converted principal (inclusive of principal amount of First Lien Notes that are voluntarily converted). As of August 8. 2020, approximately $9.9 million principal amount of Second Lien Notes remained outstanding.

 

Other than as amended by the Amendment, the remaining terms of the Note Purchase and Exchange Agreement and the Second Lien Notes remain in full force and effect. The foregoing descriptions in this Current Report on Form 8-K of the material terms of the Amendment do not purport to be complete descriptions of the rights and obligations of the parties thereunder and are qualified in their entirety to the Amendment, which the Company expects to file as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.

 

Issuance and Sale of Convertible Preferred Stock to Masters

 

Stock Purchase Agreement

 

On August 9, 2020 the Company entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) with Masters Special Situations, LLC and certain affiliates thereof (“Masters” or the “Preferred Stock Purchasers”). Pursuant to the Stock Purchase Agreement, the Company has agreed to issue and sell to the Preferred Stock Purchasers 3,000 shares of convertible preferred stock, designated as “Series A Convertible Preferred Stock” (the “Series A Preferred Stock”), at a price of $1,000.00 per share in an initial closing (the “Initial Closing”), having the terms set forth in the Certificate of Designations described below.

 

In addition, the Preferred Stock Purchasers or their assignees have the option to purchase up to an additional 27,000 shares of Series A Preferred Stock at a price of $1,000.00 per share in a subsequent closing, subject to the terms and conditions of the Stock Purchase Agreement, upon the later to occur of 90 days following the Initial Closing or the date 10 days after the Company receives stockholder approval to increase its authorized common stock by an amount sufficient to permit conversions of the Series A Preferred Stock, but in any event no later than 150 days after the Initial Closing, and subject to specified conditions.

 

Certificate of Designations

 

In connection with the entry into the Stock Purchase Agreement, the Company and Masters agreed upon a form of Certificate of Designations (the “Certificate of Designations”) to set forth the terms of the Series A Preferred Stock, which the Company will file with the State of Delaware prior to the Initial Closing. Pursuant to the Certificate of Designations, each share of Series A Preferred Stock will initially be convertible into a number of shares of Common Stock equal to $1,000 divided by the conversion price of $0.476 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. The Series A Preferred Stock will rank senior to the Common Stock. Upon a liquidation, dissolution or winding up of the Company, each share of Series A Preferred Stock will be entitled to receive an amount per share equal to the greater of the purchase price paid and the amount that the holder would have been entitled to receive at such time if the Series A Preferred Stock were converted into Common Stock (the “Series A Liquidation Amount”). The holders will also be entitled to participate in dividends declared or paid on the Common Stock on an as-converted basis. If the Company undergoes a change of control, each holder has the right to cause the Company to redeem any or all of the Series A Preferred Stock for cash consideration equal to the Series A Liquidation Amount.

 

 

 

 

The holders of Series A Preferred Stock generally will be entitled to vote with the holders of the shares of Common Stock on all matters submitted for a vote of holders of shares of Common Stock (voting together with the holders of shares of Common Stock as one class) on an as-converted basis. Additionally, certain matters will require the approval of the majority of the outstanding Series A Preferred Stock, voting as a separate class, including (i) altering or changing adversely the powers, privileges, preferences or rights of the Series A Preferred Stock, or (ii) amendments, modifications, repeal or waiver of any provision of the Company’s certificate of incorporation, bylaws or of the certificate of designations that would adversely affect the rights, preferences, privileges or powers of the Series A Preferred Stock.

 

Registration Rights Agreement

 

In connection with the entry into the Stock Purchase Agreement, the Company and Masters entered into a registration rights agreement (the “Masters RRA”), pursuant to which the Company has agreed to register the resale of any shares issuable upon conversion of the Series A Preferred Stock (the “Masters Registrable Securities”), pursuant to a registration statement on Form S-3 to be filed with the SEC. Pursuant to the Masters RRA, the Company has agreed to file the Form S-3 no later than September 23, 2020, and to have it declared effective no later than 90 days thereafter, such registration statement on Form S-3.

 

The Company will pay liquidated damages if the resale documents are not timely filed or made effective or if the resale documents are unavailable for periods in excess of those permitted. Such liquidated damages will equal 0.5% of the aggregate amount invested by each holder for each 90-day period (or a pro rata portion thereof) following a default up to a maximum of 2.0%.

 

In addition, the holders of at least a majority of the Masters Registrable Securities have the right to demand that the Company effect one underwritten public offering or block trade of the Masters Registrable Securities, provided that the demand relate to all Masters Registrable Securities then outstanding or the aggregate market value of the Masters Registrable Securities to be included in such offering is at least $7.5 million. These registration rights are subject to specified conditions and limitations, including the right of a managing underwriter to limit the number of shares included in any such registration under specified circumstances.

 

Further, the holders of Masters Registrable Securities are entitled to certain piggyback registration rights if there is not otherwise an effective registration statement covering all of the Masters Registrable Securities or if Rule 144 is not available with respect to the Masters Registrable Securities. The Masters RRA contains customary other terms, conditions and other provisions.

 

Investor Rights Agreement

 

In connection with the entry into the Stock Purchase Agreement, the Company and Masters entered into an investor rights agreement (the “Masters IRA”). Pursuant to the Masters IRA, for so long as Masters and its affiliates beneficially own at least 5% of the Company’s Common Stock, Masters will have the right to designate one member of the Board (the “Masters Designee”). Masters will designate and the Board will appoint the initial Masters Designee within 45 days of the Initial Closing.

 

In addition, pursuant to the Masters IRA, if the Company intends to issue new equity or equity-linked securities to any person, then each Preferred Stock Purchaser has the right to participate in such transaction on a pro rata basis, subject to customary exceptions.

 

 

 

 

The foregoing descriptions in this Current Report on Form 8-K of the material terms of the Stock Purchase Agreement, the Masters RRA, the Masters IRA and the Certificate of Designations do not purport to be complete descriptions of the rights and obligations of the parties thereunder and are qualified in their entirety to the Stock Purchase Agreement, the Masters RRA, the Masters IRA and the Certificate of Designations, which the Company expects to file as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.

 

Item 2.02. Results of Operations and Financial Condition.

 

On August 10, 2020, the Company issued a press release announcing its financial results for the quarter ended June 30, 2020, as well as information regarding a conference call to discuss these financial results, the transactions described in Item 1.01 above, 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.    

 

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 (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.

 

Item 2.03. Creation of a Direct Financial Obligation or an Obligation Under an Off-Balance Sheet Arrangement of a Registrant.

 

The information in Item 1.01 above is incorporated by reference into this Item 2.03

 

Item 3.02. Unregistered Sales of Equity Securities

 

The information contained in Item 1.01 of this Current Report is incorporated by reference into this Item 3.02.

 

The Company intends to rely on the exemption from registration under Regulation D promulgated under the Securities Act and Section 4(a)(2) of the Securities Act, for the issuance of the Financing Fee Shares, the PHC Preferred Stock and the Series A Preferred Stock. Each holder of the securities represented that it is an “accredited investor” as defined in Regulation D of the Securities Act. The Financing Fee Shares, the PHC Preferred Stock and the Series A Preferred Stock have not been registered under the Securities Act, or state securities laws, and may not be offered or sold in the United States without either being first registered or otherwise exempt from registration in any further resale or disposition.

 

Item 3.03. Material Modification to Rights of Security Holders

 

The information contained in Item 1.01 of this Current Report is incorporated by reference into this Item 3.03.

 

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

 

The information contained in Item 1.01 of this Current Report is incorporated by reference into this Item 5.02.

 

Item 7.01. Regulation FD Disclosure

 

A copy of the press release announcing the Company’s entry into the agreements described above with Ascensia, PHC and Masters is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

 

The information contained in this Item 7.01 as well as in Exhibit 99.2 attached hereto, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of 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 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 No. Description
   
99.1 Press release dated August 10, 2020
   
99.2 Press release dated August 10, 2020

 

This Current Report on Form 8-K is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale is unlawful. The offer, issuance and sale of the Notes, the Financing Fee Shares, PHC Preferred Stock and Series A Preferred Stock, as well as the shares of common stock issuable upon conversion of the Notes, the PHC Preferred Stock and the Series A Preferred Stock, if any, will not be registered under the Securities Act or any state securities laws, and unless so registered, such shares may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state laws.

 

Forward Looking Statements

 

Any statements in this Current Report on Form 8-K about future expectations, plans and prospects for the Company, including statements about the closing of the transactions discussed herein, the use of proceeds from the Notes, the potential issuances of additional shares of convertible preferred stock and the future conversion or repayment of the Notes and the convertible preferred stock, 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, the uncertain outcome, impact, timing, effects and results of the Company’s exploration of strategic alternatives, the ability of the Company to enter into or consummate a strategic transaction with a third party, the uncertainty of receiving the Stockholder Approval, uncertainties in the development and regulatory approval processes, effects of the COVID-19 pandemic, uncertainties concerning the development of medical devices and such other factors as are set forth in the risk factors detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 16, 2020, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 to be filed with the SEC on the date hereof and the Company’s other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this Current Report on Form 8-K represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

 

 

 

 

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 10, 2020 SENSEONICS HOLDINGS, INC.
     
  By: /s/ Nick B. Tressler
  Name: Nick B. Tressler
  Title: Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

SENSEONICS HOLDINGS, INC. REPORTS SECOND QUARTER 2020 FINANCIAL RESULTS

 

GERMANTOWN, MD, August 10, 2020 —Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter ended June 30, 2020.

 

Recent Highlights & Accomplishments:

· Reduced net loss by $23.6 million to $7.5 million in the second quarter of 2020, from the prior year period, due to the execution of cost reduction actions and streamlined operational focus deployed in late March 2020
· Continued efforts to support existing patients and progress with anticipated submission to the FDA of the up to 180-day Eversense product in the U.S. in the third quarter
· Formed strategic collaboration with Ascensia Diabetes Care (Ascensia), a KKR portfolio company and leading global manufacturer and distributor of self-monitoring blood glucose devices to over 10 million world-wide diabetes patients, through a collaboration and commercialization agreement concurrent with additional financing
o Collaboration and Commercialization Agreement – Ascensia and Senseonics entered into an agreement to collaborate to maximize the value of Eversense in the worldwide market. Senseonics will remain focused on product development and manufacturing, including regulatory submissions, approvals and registrations, and Ascensia will assume sales, marketing, market access, patient and provider onboarding and customer support. Ascensia will obtain exclusive worldwide distribution rights upon launch of the 180-day Eversense product in the U.S. and the expiration of Senseonics’ current international distribution agreements in other markets. The parties will jointly share in net revenues as consideration for each party’s contributions to the success and growth of Eversense.
o Financing Agreements – Senseonics has agreed to issue $35 million through of senior secured convertible notes to Ascensia’s parent company, PHC Holdings Corporation. The agreement also provides Senseonics the option to sell and issue convertible preferred equity to PHC Holdings Corporation in the amount of up to $15 million following receipt of FDA approval for the 180-day Eversense product in the U.S. and receipt of any required shareholder approval required by the NYSE American listing rules.
o Senseonics has also signed an agreement to issue up to $30 million in convertible preferred equity to Masters Special Situations, LLC and affiliates thereof (“MSS”). The funding will take place in up to two closings, with the initial 10% expected to close on or about August 14, 2020. MSS has an option to purchase the balance of the $30 million of convertible preferred equity in a subsequent closing that would be expected to occur within the next three months, subject to the receipt of stockholder approval.
· On August 3, 2020 the Centers for Medicare and Medicaid Services (CMS) released its Calendar Year (CY) 2021 Medicare Physician Fee Schedule Proposed Rule that announces proposed policy changes for Medicare payments, including the proposed establishment of national payment amounts for the three CPT© Category III codes describing the insertion (CPT 0446T), removal (0447T), and removal and insertion (0048T) of an implantable interstitial glucose sensor, which describes the Eversense CGM system. Currently, Eversense is contractor-priced by the Medicare Administrative Contractors (MACs).

 

“Our second quarter results demonstrate significant expense and cash burn reductions resulting from our suspended commercial operations and other cost reduction initiatives. We continue to support our installed base of users efficiently in anticipation of the 180-day Eversense product submission and subsequent planned launch in the U.S. early in 2021, if approved. At this point over 75% of our users are on at least their second sensor, where we continue to see a high level of patient engagement as people with diabetes are keenly focused on their healthcare during these times. Anticipated revenue headwinds were caused by our reduced commercial operations and early in the quarter impacts of the COVID-19 pandemic,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “Moving forward we are in a stronger position to help patients with diabetes. Our collaboration with Ascensia represents a mutual commitment to penetrating the CGM market with Eversense and the next phase of growth for Senseonics. In addition, building upon our success with the MACs, CMS has included a national payment amount for implantable CGMs in the proposed 2021 physician fee schedule as a medical benefit, which could lead to access to Eversense for millions of Medicare recipients. We are very excited about the opportunity ahead of us.”

 

 

 

 

 

Anticipated Key Milestones:

Q3 2020 – Submit 180-day Eversense product to FDA for approval with reduced calibration

Q3 2020 – Shareholder meeting to approve future financings

Q4 2020 – Restart of US Sales and Marketing activities in the U.S. with Ascensia

Q1 2021 – Proposed Medicare National Payment Schedule Implementation

Q1 2021 – Initiation of O.U.S. commercial activities by Ascensia

Q1 2021 – Expected decision on approval of 180-day Eversense product by FDA

H1 2021 – Planned IDE approval of 365-day Eversense clinical trial by FDA, including pediatric population

H2 2021 – Planned enrollment of 365-day Eversense clinical trial by FDA, including pediatric population

 

Second Quarter 2020 Results:

In the second quarter of 2020, revenue was reduced due to the temporary suspension of commercial operations in March in the U.S. after the repayment of the Solar Capital loan, as well as the effects of temporary patient deferments resulting from the pandemic. Total net revenue for the quarter was $261 thousand compared to total net revenue of $4.6 million for the second quarter of 2019. U.S. net revenue was $206 thousand after accounting for gross to net adjustments. Net revenue outside the U.S. was $55 thousand due to the deferral of orders by Roche. Gross revenue for the second quarter of 2020 was $165 thousand.

 

Second quarter 2020 gross profit increased by $3.4 million year-over-year, to ($1.1) million.

 

Second quarter 2020 sales and marketing expenses decreased by $11.0 million year-over-year, to $3.1 million. The decrease was primarily due to the recent changes in commercial activities.

 

Second quarter 2020 research and development expenses decreased by $6.7 million year-over-year, to $3.8 million. The decrease was primarily driven by lower clinical study costs and personnel related expenses.

 

Second quarter 2020 general and administrative expenses decreased by $1.0 million year-over-year, to $4.4 million. The decrease was primarily due to a decline in personnel related expenses, legal fees and other administrative costs.

 

Net loss was $7.5 million, or $0.03 per share, in the second quarter of 2020, compared to $31.1 million, or $0.17 per share, in the second quarter of 2019.

 

As of June 30, 2020, cash, cash equivalents and restricted cash were $21.6 million and outstanding indebtedness was $106.4 million.

 

The company anticipates annualized cash burn will be below $60 million. If the company closes the full amount of potential financings as announced as part of these agreements, the company expects to be able to fund its operations through 2021.

 

Conference Call and Webcast Information

Company management will host a conference call at 4:30 pm (Eastern Time) today, August 10, 2020, 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: 877-883-0383

Entry Number: 7703001

International dial in: 412-902-6506

Live Webcast Information:

Visit http://www.senseonics.com and
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.

 

Non-GAAP Financial Measures

In accordance with U.S. GAAP, Senseonics reports revenue in its financial statements on a net basis, which takes into account gross to net reductions resulting from discount programs, such as the Eversense Bridge Program. To supplement its unaudited condensed consolidated financial statements, which are prepared and presented in accordance with U.S. GAAP and present total revenue, net, Senseonics is also providing investors with gross revenue. These measures do not reflect the gross to net reductions from these discount programs and, accordingly, may be considered to be non-GAAP financial measures. The presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP, and Senseonics’ non-GAAP measures may be different from non-GAAP measures used by other companies.

 

Senseonics uses these non-GAAP financial measures for financial and operational decision-making. Senseonics’ management believes that these non-GAAP financial measures provide meaningful supplemental information regarding Senseonics’ performance and provide better transparency on the impact of reimbursement and the Eversense Bridge Program. Senseonics believes that both management and investors benefit from referring to these non-GAAP financial measures in assessing Senseonics’ performance and when planning, forecasting, and analyzing future periods. For more information on these non-GAAP financial measures, please see the reconciliation of these non-GAAP financial measures to their nearest comparable GAAP measures at the end of this press release.

 

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about the potential benefits of the Ascensia commercialization and collaboration agreement, potential coverage decisions, the potential impact or meaning of coverage decisions, including without limitation making Eversense available, claim adjudication, and the potential life-enhancing benefits Eversense offers people with diabetes, the potential FDA Premarket Approval application for the 180-day Eversense product, the timing of future milestones, including dates of enrollment for clinical trials, dates of regulatory filings with the FDA and decisions by the FDA, the availability and closing of future financing, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” 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, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, the necessity of receiving stockholder approval that will be required in order to raise all of the capital pursuant to the preferred stock and certain debt transactions described in this release, 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, 2019, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 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

 

Senseonics Media Contact:

Mirasol Panlilio

301-556-1631

Mirasol.panlilio@senseonics.com

 

 

 

 

 

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,  
    2020     2019     2020     2019  
Revenue, net   $ 216     $ 1,475     $ 247     $ 2,718  
Revenue, net - related parties     45       3,132       50       5,312  
Total revenue     261       4,607       297       8,030  
Cost of sales     1,404       9,160       21,074       15,893  
Gross profit     (1,143 )     (4,553 )     (20,777 )     (7,863 )
                                 
Expenses:                                
Sales and marketing expenses     3,142       14,179       14,287       27,013  
Research and development expenses     3,796       10,504       11,159       17,612  
General and administrative expenses     4,445       5,417       10,134       11,933  
Operating loss     (12,526 )     (34,653 )     (56,357 )     (64,421 )
Other income , net:                                
Interest income     8       410       217       1,037  
Loss on extinguishment of debt     (6,385 )     —       (10,931 )     —  
Interest expense     (3,555 )     (1,965 )     (7,928 )     (3,999 )
Change in fair value of derivatives     15,238       4,889       25,549       6,961  
Other (expense) income     (295 )     245       (658 )     (17 )
   Total other income, net     5,011       3,579       6,249       3,982  
                                 
Net loss     (7,515 )     (31,074 )     (50,108 )     (60,439 )
Total comprehensive loss   $ (7,515 )   $ (31,074 )   $ (50,108 )   $ (60,439 )
                                 
Basic and diluted net loss per common share   $ (0.03 )   $ (0.17 )   $ (0.24 )   $ (0.34 )
Basic and diluted weighted-average shares outstanding     220,305,606       177,012,497       212,025,792       176,983,467  

 

 

 

 

 

Senseonics Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

 

    June 30,     December 31,  
    2020     2019  
      (unaudited)          
Assets                
Current assets:                
Cash and cash equivalents   $ 21,397     $ 95,938  
Restricted cash     200       —  
Accounts receivable     670       3,239  
Accounts receivable - related parties     —       7,140  
Inventory, net     4,150       16,929  
Prepaid expenses and other current assets     5,688       4,512  
Total current assets     32,105       127,758  
                 
Derivative assets     4,245       —  
Deposits and other assets     2,716       3,042  
Property and equipment, net     1,771       2,001  
Total assets   $ 40,837     $ 132,801  
                 
Liabilities and Stockholders’ Equity (Deficit)                
Current liabilities:                
Accounts payable   $ 106     $ 4,285  
Accrued expenses and other current liabilities     12,174       18,636  
Term Loans, net     —       43,434  
2025 Notes , net     —       60,353  
Total current liabilities     12,280       126,708  
                 
Long-term debt and notes payable, net     61,192       11,800  
Derivative liabilities     5,075       664  
Other liabilities     1,895       2,278  
Total liabilities     80,442       141,450  
                 
Commitments and contingencies                
                 
Stockholders’ deficit:                
Common stock, $0.001 par value per share; 450,000,000 shares authorized; 230,551,676 and 203,452,812 shares issued and outstanding as of June 30, 2020 and December 31, 2019     231       203  
Additional paid-in capital     483,615       464,491  
Accumulated deficit     (523,451 )     (473,343 )
Total stockholders' deficit     (39,605 )     (8,649 )
Total liabilities and stockholders’ deficit   $ 40,837     $ 132,801  

 

 

 

 

 

Senseonics Holdings, Inc.

Reconciliation of Total Revenue, Net to Gross Revenue

(in thousands)

 

    For the Three Months Ended
June 30, 2020 		    For the Six Months Ended
June 30, 2020 		 
Revenue, net   $ 261     $ 297  
Gross to net     (96 )     1,892  
reductions(additions)                
Gross revenue   $ 165     $ 2,189  

 

Senseonics Holdings, Inc.

Reconciliation of U.S. Revenue, Net to U.S. Gross Revenue

(in thousands)

 

    For the Three Months Ended
June 30, 2020 		    For the Six Months Ended
June 30, 2020 		 
U.S. Revenue, net   $ 206     $ 230  
Gross to net     (96 )     1,892  
reductions (additions)                
U.S. Gross revenue   $ 110     $ 2,122  

 

 

 

 

 Exhibit 99.2

 

 

 

Senseonics Announces Strategic Collaboration with Ascensia Diabetes Care

 

· Broad Partnership Features Global Commercialization and Financing Arrangements with Leader in Blood Glucose Monitoring
· Company has Entered into Financing Agreements for up to $80 Million to Provide Additional Liquidity
· Senseonics to Focus Streamlined Operations on Manufacturing, Research and Development of Next Generations of EversenseÒ Systems

 

GERMANTOWN, MD, August 10, 2020 -- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the formation of a strategic partnership with Ascensia Diabetes Care (Ascensia), through a commercialization and collaboration agreement, which will make Ascensia the exclusive worldwide distributor of Senseonics’ EversenseÒ CGM systems. The company also announced a concurrent financing agreement with PHC Holdings Corporation, the parent company of Ascensia. In addition, Senseonics also announced a financing agreement with Masters Special Situations, LLC and affiliates thereof (“MSS”). The financing arrangements collectively provide for a total of up to $80 million of debt and equity capital.

 

Ascensia Diabetes Care is a global diabetes care company that is dedicated to helping people living with diabetes. It is a leader in the blood glucose monitoring (BGM) market with its CONTOURÒ portfolio of devices that are known for their accuracy and ease of use. Ascensia markets its BGM devices in over 125 countries across the world. The Switzerland based company is owned by PHC Holdings Corporation, a KKR portfolio company.

 

“We are extremely excited to be partnering with Ascensia, a leader in the global diabetes space. Ascensia is well known for their high-quality CONTOUR products used by more than 10 million patients world-wide to help manage their diabetes. We believe their global commercial infrastructure and commitment to the Eversense systems will drive market adoption while allowing Senseonics to focus on further development of our implanted technology,” said Tim Goodnow, PhD, President and CEO of Senseonics.

 

Under the terms of the agreements, Ascensia will become the exclusive worldwide distribution partner for Senseonics’ CGM systems including EversenseÒ, EversenseÒ XL and future generation products. In the U.S., Ascensia will initiate marketing and sales activities in the coming months, with full responsibility and commercial ramp up expected in the first quarter of 2021. In the U.S., the commercial efforts for the remainder of 2020 are intended to re-initiate marketing Eversense to drive new patient starts, as well as to prepare for the launch of the new 180-day Eversense product, if approved. In Europe, Ascensia will begin commercialization activities in select countries where Eversense XL has already launched, once any existing distribution relationships have concluded. These exclusive distribution rights are expected to last through 2025, with the exact timing dependent on factors including the launch dates for certain future generation products.

 

Ascensia’s parent company, PHC Holdings Corporation, will also provide up to $50 million to Senseonics through (i) the purchase of $35 million in aggregate principal amount of convertible debt securities in a transaction expected to close on or about August 14, 2020 and (ii) a commitment to purchase up to an additional $15 million in convertible preferred stock, at Senseonics’ option and contingent upon FDA approval of the 180-day Eversense sensor in the U.S.. Both organizations share a vision focused on providing leading technology to diabetes patients around the world to lessen the burden of disease management. With strong commitments to collaboration, Senseonics will enhance focus on advancing its pipeline of long-term implantable CGM solutions, while Ascensia will be responsible for sales, marketing, market access, patient and provider onboarding, and customer support.

 

 

 

 

 

“In line with our goal of ensuring the long-term success of Eversense in the marketplace, Ascensia has demonstrated a high level of commitment to our products that we expect will be beneficial for patients and healthcare providers for years to come,” said Francine Kaufman, MD, Chief Medical Officer of Senseonics.

 

“We are thrilled to be entering into this partnership with Senseonics and strongly believe in the value of the Eversense technology. They have highly accurate and effective products on the market and a strong pipeline of innovative solutions that can address the needs of people with diabetes,” said Robert Schumm, President of Ascensia Diabetes Care. “We believe that the combination of our commercial expertise and infrastructure, alongside Senseonics’ focus on product development and manufacturing, will help to get the Eversense and Eversense XL products into the hands of people with diabetes who can benefit from them. Our aim is to work together to bring these highly effective technologies to more people with diabetes, therefore providing further choice in CGM for diabetes management.”

 

Collaboration and Commercialization Agreement

The collaboration and commercialization agreement is designed to drive adoption of the Eversense CGM systems and future product generations by combining the strengths of the two organizations. Incentives for penetration of the market are aligned through a mutually beneficial revenue sharing agreement. Senseonics will retain all product development, branding, regulatory approval and manufacturing responsibilities.

 

Ascensia will assume exclusive commercialization rights of Senseonics’ products for five years following U.S. availability of the 180-day Eversense product including the associated expenses, subject to extension in certain circumstances. Throughout 2020, Senseonics will lead a collaborative program for the Ascensia commercial team to receive field-based training and hands on experience supporting the current Eversense patient base as well as new patient and practice on-boarding. This creates the potential to increase the overall installed base later this year. Upon the launch of the 180-day product in the U.S., if approved, Ascensia will assume full marketing, market access, sales, healthcare provider training, and frontline patient and provider support responsibilities. Ascensia has begun expanding its U.S. commercial organization and expects to be fully staffed by end of the first quarter 2021 in support of Eversense.

 

Financing Agreements

Senseonics has entered into an agreement to issue senior secured convertible notes to PHC Holdings Corporation in the amount of $35 million at a 9.5% interest rate that reduces to 8.0% if the Eversense 180-day system is approved in the U.S., subject to certain conditions. The maturity date of the notes will be October 31, 2024. Funding will occur at the closing, which is expected to occur on or about August 14, 2020. The notes will be convertible into common stock at any time at an effective conversion premium of approximately 12.5% to the closing stock price on August 7, 2020. Additionally, Senseonics has the option to issue convertible preferred stock to PHC Holdings Corporation in the aggregate purchase price of up to $15.0 million, following approval of the Eversense 180-day system in the U.S, subject to stockholder approval.

 

Senseonics has also signed an agreement to issue up to $30 million in convertible preferred equity to Masters Special Situations, LLC and affiliates thereof (“MSS”). The funding will take place in up to two closings, with the initial 10% expected to close on or about August 14, 2020. MSS has an option to purchase the balance of the $30 million of convertible preferred equity in a subsequent closing that would be expected to occur within the next three months, subject to the receipt of stockholder approval.

 

The capital from these financings will be used to support product development initiatives, including the regulatory efforts for the Eversense 180-day system in the U.S. and the development of future generation products, as well as for supporting users in the U.S.

 

 

 

 

 

In connection with the transactions described above, PHC Holdings Corporation will have the right to nominate two board members to the board and MSS will have the right to nominate one board member to the board, which board members are expected to join the board within 45 days.

 

About Eversense

The Eversense® brand of continuous glucose monitoring (CGM) systems are indicated for continually measuring glucose levels in persons age 18 and older with diabetes.  The Eversense® CGM system, available in the U.S. is indicated for up to 90 days and as a replacement of fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration twice per day, and when symptoms do not match CGM information or when taking medications of the tetracycline class.  The Eversense® XL CGM system, available outside of the U.S., is indicated for up to 180 days and is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal procedures for both systems are performed by a health care provider. The Eversense and Eversense XL CGM systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://eversensediabetes.com/safety-info/.

 

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.

 

About Ascensia Diabetes Care

Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Their mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. They use innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.

 

Home to the world-renowned CONTOUR® portfolio of blood glucose monitoring systems, Ascensia’s products combine advanced technology with user-friendly functionality that help people with diabetes to manage their condition.

 

Ascensia Diabetes Care was established in 2016 through the sale of Bayer Diabetes Care to PHC Holdings Co., Ltd (formerly Panasonic Healthcare Holdings Co., Ltd). Ascensia Diabetes Care products are sold in more than 125 countries. Ascensia Diabetes Care has around 1,700 employees and operations in 31 countries.

 

For further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com.

 

©2020 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

 

About Masters Special Situations, LLC

 

Masters Special Situations, LLC (“MSS”) is an affiliate of Masters Capital Management, LLC, an SEC registered investment adviser based in Atlanta, Georgia. MSS invests growth capital in innovative, small cap public companies in the United States.

 

 

 

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about the potential benefits of the Ascensia commercialization and collaboration agreement, the commercialization plans for Eversense and Eversense XL in 2020 and 2021, Ascensia’s full staffing of their commercial organization by end of the first quarter 2021, the receipt of future capital pursuant to the agreements described in this release, the potential increase in the overall Eversense installed base and new patient starts, the potential for FDA approval and launch of the Eversense 180-day system in the U.S., the development of future generations of products, 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 transition of commercial activities to Ascensia, commercial launch and commercial expansion of the product, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, the necessity of receiving stockholder approval that will be required in order to raise all of the capital pursuant to the preferred stock transactions described in this release, 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, 2019, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 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.

 

Senseonics Investor Contact

Lynn Lewis or Philip Taylor

Investor Relations

415-937-5406

investors@senseonics.com

 

Senseonics Media Contact:

Mirasol Panlilio

301-556-1631

Mirasol.panlilio@senseonics.com