Current Report Filing (8-k)
April 20 2018 - 4:03PM
Edgar (US Regulatory)
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): April 18, 2018
SIENTRA, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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001-36709
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20-5551000
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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420 South Fairview Avenue, Suite 200
Santa Barbara, CA 93117
(Address of principal executive offices, with zip code)
(805)
562-3500
(Registrants telephone number, including area code)
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.):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to
Rule 14a-12
under the Exchange Act (17 CFR
240.14a-12)
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☐
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Pre-commencement
communications pursuant to
Rule 14d-2(b) under
the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to
Rule 13e-4(c) under
the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule
12b-2
of the Securities Exchange Act of 1934 (17 CFR
§240.12b-2).
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
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Results of Operations and Financial Condition.
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On April 18, 2018, Sientra, Inc.
(the Company) entered into a first amendment (the Amendment) to its Credit and Security Agreement (Term Loan) (the Agreement) with MidCap Financial Trust and the financial institutions that are or become parties
to the Agreement as lenders. Pursuant to the Amendment, the parties agreed to adjust the date by which the Company must obtain FDA approval of its PMA supplement in order to access the $10.0 million second tranche loan until April 30,
2018. The foregoing description of the terms of the Amendment is qualified in its entirety by reference to the text of such document, a copy of which is filed as Exhibit 10.1 to this Current Report on Form
8-K.
Item 2.03
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Creation of a Direct Financial Obligation or an Obligation under an
Off-Balance
Sheet Arrangement of a Registrant.
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The information included in Item 1.01 of this Current Report on Form
8-K
is incorporated by reference
into this Item 2.03.
On April 18, 2018, the Company announced U.S. Food and Drug
Administration (FDA), approval of the Companys third and final FDA submission for enhanced manufacturing processes at its U.S. manufacturing facility, authorizing the sale of Sientra OPUS branded breast implants manufactured
by Vesta. The text of the press release announcing the FDA approval is attached hereto as Exhibit 99.1 to this Current Report on Form
8-K.
Item 9.01.
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Financial Statements and Exhibits.
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Exhibit
No.
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Description
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10.1
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Amendment No.
1 to Credit and Security Agreement (Term Loan), dated April 18, 2018, by and among Sientra, Inc., miraDry Holdings, Inc., miraDry, Inc., MidCap Financial Trust and certain other financial institutions as lenders.
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99.1
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Press release dated April 18, 2018
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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.
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SIENTRA, INC.
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Date: April 19, 2018
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By:
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/s/
Jeffrey M. Nugent
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Jeffrey M. Nugent
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Chairman of the Board of Directors and
Chief
Executive Officer
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