Item 7.01 Regulation FD Disclosure.
On December 23, 2020, Senseonics Holdings, Inc. (the "Company") issued a press
release announcing certain financial and operational business updates (the
"Press Release"). A copy of the Press Release 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 Press Release
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 8.01 Other Events.
On January 11, 2021, the Company completed the final closing of its previously
announced private placement of Series A Preferred Stock, pursuant to the Stock
Purchase Agreement (the "Stock Purchase Agreement") dated August 9, 2020 by and
among the Company and Masters Special Situations, LLC, Marlin Fund, Limited
Partnership and Marlin Fund II, Limited Partnership (collectively, the "Masters
Purchasers"). In total, including the previously announced initial closing, the
Company sold $25.8 million of Series A Preferred Stock to the Masters Purchasers
and certain of their assignees. By virtue of the subsequent closings, pursuant
to the previously announced Investor Rights Agreement dated July 9, 2020,
Masters Special Situations, LLC has retained its right to designate one director
for election to the Company's board of directors at the Company's 2021 Annual
Meeting of Stockholders.
In connection with the completion of the financing, the Company and the
Purchasers (as defined in the Stock Purchase Agreement, and which now include
the assignees who have purchased shares of Series A Preferred Stock in the
financing) entered into an amendment to the Resale Registration Rights Agreement
dated August 9, 2020, to extend the deadline for filing a resale registration
statement covering the shares of common stock issuable upon conversion of the
Series A Preferred Stock to February 15, 2021.
On December 23, 2020, the Company announced in the Press Release, among other
financial and operational business updates, that it had received communication
from the U.S. Food and Drug Administration ("FDA") explaining that the
reallocation of agency resources to address Emergency Use Authorization
applications for products related to the COVID-19 public health emergency is
affecting marketing application reviews, including the Eversense 180-day
product, which will be delayed by at least 60 days, although the precise
duration cannot be known due to the uncertainty associated with the pandemic and
the volume of COVID-19 EUA submissions. It is the Company's understanding that
multiple sponsors have received this notification from the FDA regarding the
anticipated delays in regulatory reviews resulting from the FDA's resource
reallocation decisions. The Company believes that there is still the potential
for a decision by the FDA by the end of the second quarter of 2021. The Press
Release also announced the inclusion of Eversense Category III CPT codes in the
Centers for Medicare & Medicaid Services (CMS) 2021 Physician Fee Schedule
(PFS), establishing global payment for the device cost and procedure fees for
healthcare providers across the United States. The Press Release also announced
the entry into an agreement with Roche to provide for the orderly transition of
distribution activities to Ascensia Diabetes Care in the Roche European
territories where it will commence distributing the product effective February
1, 2021, the winding up of Roche's distribution activities, and resolution of
final Roche purchases and other matters between the parties.
Forward-Looking Disclaimer:
Any statements in this report about future expectations, plans and prospects for
Senseonics, including statements concerning the potential approval by the FDA of
the Company's 180-day Eversense product and Ascenia Diabetes Care's commencement
of European distribution of the Company's products, 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 the impacts of
the ongoing COVID-19 pandemic on the Company's business, including the duration
and severity of the resource relocation within the FDA and related implications
for the timing of FDA's evaluation of the 180-day Eversense product, the extent
of EUA requests the FDA receives, the uncertainties associated with
transitioning responsibility for European distribution from Roche to Ascensia,
and 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 September 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number Exhibit Description
99.1 Press release, dated as of December 23, 2020
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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