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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): January 29, 2024
Biofrontera
Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-40943 |
|
47-3765675 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
120
Presidential Way, Suite 330
Woburn,
Massachusetts |
|
01801 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (781) 245-1325
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:
☐ |
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 Exchange Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock, par value $0.001 per share |
|
BFRI |
|
The
Nasdaq Stock Market LLC |
Preferred
Stock Purchase Rights |
|
|
|
The
Nasdaq Stock Market LLC |
Warrants
to purchase common stock |
|
BFRIW |
|
The
Nasdaq Stock Market LLC |
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 (the “Exchange Act”) (§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. |
On
January 29, 2024, Biofrontera Inc. (the “Company”) entered into an amendment and restatement (the “Amendment”),
effective January 26, 2024, of an Addendum (the “Addendum”), entered into on December 12, 2023, to its Amended and
Restated License and Supply Agreement, dated as of June 16, 2021 (as previously amended, the “LSA”), by and among the Company,
Biofrontera Pharma GmbH (“Pharma”), and Biofrontera Bioscience GmbH (“Bioscience”). The Amendment modifies a
schedule of payments in relation to various financial obligations among the Company, Pharma, Bioscience, and Biofrontera AG (the parent
company of Pharma and Bioscience), including terms relating to payments by the Company to Pharma for purchases of Licensed Products (as
that term is defined in the LSA) under the LSA previously agreed to in the Addendum. Among other things, the Addendum provides that payment
that was due from the Company on January 31, 2024 has been deferred to February 29, 2024.
This
description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment,
a copy of which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 8.01 Other Events.
On February 2, 2024, an institutional investor
exercised pre-funded warrants (the “Exercise”) to purchase 888,000 shares of the Company’s common stock, par
value $0.001 per share. The warrants had been issued to the institutional investor pursuant to a public offering (the “Public
Offering”) previously reported on the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission
on November 2, 2023. As a result of the Exercise, all pre-funded warrants issued in the Public Offering have now been exercised.
Following the Exercise, the
total number of the Company’s outstanding shares is 2,572,628.
Item
9.01 |
Financial
Statements and Exhibits. |
SIGNATURE
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.
February
2, 2024
(Date) |
|
Biofrontera
Inc.
(Registrant) |
|
|
|
|
By: |
/s/
E. Fred Leffler III |
|
|
E.
Fred Leffler III |
|
|
Chief
Financial Officer |
Exhibit
10.1
Amended
and Restated Addendum to
Amended
and Restated License and Supply Agreement
This
Amended and Restated Addendum to Amended and Restated License and Supply Agreement (the “Amended Addendum”) is made effective
as of January 26, 2024, by and between Biofrontera AG (“AG”), Biofrontera Pharma GmbH (“PHARMA”), and Biofrontera
Bioscience GmbH (“BIOSCIENCE”), each a German corporation/company with its principal offices at Hemmelrather Weg 201, 51377
Leverkusen, Germany, and Biofrontera Inc., a Delaware corporation with its principal place of business at 120 Presidential Way, Woburn,
MA 01801, USA (“INC”). AG, PHARMA, BIOSCIENCE, and INC may collectively be referred to as the “Parties” or individually
as a “Party.” Capitalized terms used but not defined herein shall have the meanings assigned to them in the Agreement, as
defined below.
Recitals
Whereas,
PHARMA, BIOSCIENCE, and INC have entered into an Amended and Restated License and Supply Agreement, dated as of June 16, 2021, as amended
by that certain Corrected Amendment to Amended and Restated License and Supply Agreement, dated as of October 8, 2021 (collectively,
the “Agreement”);
Whereas,
the Parties added additional terms to the Agreement in regard to certain mutual payment obligations between the Parties on December 5,
2023 by executing a certain Addendum to Amended and Restated License and Supply Agreement (the “Addendum”),
Whereas,
the parties wish to modify and restate the terms of the Addendum as described below; and
Now,
therefore, in consideration of the foregoing and the agreements contained herein, the Parties hereto, intending to be legally bound hereby,
agree as follows:
Agreement
1. | Payment
Obligations. This Addendum pertains to the payment of the following obligations of each
of the Parties (collectively, the “Payment Obligations”): |
|
a. |
INC’s
payment of Invoice No. DARM00429 to PHARMA; |
|
|
|
|
b. |
INC’s
payment of Invoice No. AR01207 (as adjusted to reflect termination of IT services on December 19, 2022) to PHARMA; |
|
|
|
|
c. |
INC’s
payment of Invoices No DARM0043, DARM00444, DARM00484 to PHARMA; |
|
|
|
|
d. |
INC’s
payment of invoices No TAR01584 and No.TAR01593 (services issues) to BIOSCIENCE; |
|
|
|
|
e. |
BIOSCIENCE’s
payment of Invoice Nos. BioSci 2023-Q3, BioSci 2023-10, and BioSci 2023-09 to INC; |
|
|
|
|
f. |
INC’s
payment of an invoice to be issued by PHARMA in relation to PO #11440 (for the purchase of Ameluz); |
|
g. |
AG’s
reimbursement of its 50% share of the “Third Installment” payment under a certain “Amended Settlement Allocation
Agreement” between INC and AG dated March 31, 2023 to INC; |
|
|
|
|
h. |
INC’s
payment of the purchase price variance as described in Section 6.5 of the Agreement for the year ending December 31, 2023 (“2023
PPV”) to PHARMA; |
|
|
|
|
i. |
INC’s
payments of invoices to be issued by PHARMA in relation to POs #11272, #11305, and #11154; and |
|
|
|
|
j. |
BIOSCIENCE’s
payment of invoices to be issued by INC in relation to clinical services provided to BIOSCIENCE in Q4 2023. |
2. | Payment
Schedule. To satisfy the Payment Obligations in full, the Parties agree to the following
payment schedule (collectively, the “Payment Schedule”): |
|
a. |
On
or before December 20, 2023, INC will pay to PHARMA $2.791M towards DARM0043, DARM00444, DARM00484 and DARM00429. |
|
|
i. |
This
sum shall be reduced by any outstanding payments from BIOSCIENCE to INC under Invoice Nos. BioSci 2023-Q3, BioSci 2023-10, and BioSci
2023-09 (currently, approximately $137K). |
|
b. |
On
or before February 29, 2024, INC will pay to PHARMA i) the remainder owed under DARM00429 (approximately $1.4-1.6M), and ii) the
full amount owed under the invoice to be issued by PHARMA in relation to PO # 11440 (estimated at approximately $2.9M). |
|
|
i. |
On
January 31, 2024, the outstanding sum owed by INC to PHARMA under Section 2(b) above shall be reduced by any outstanding reimbursement
from AG to INC for AG’s 50% share of the “Third Installment” payment under the “Amended Settlement Allocation
Agreement” between INC and AG dated March 31, 2023 (currently, $2.815M) and any outstanding payments from BIOSCIENCE to INC
in relation to clinical services provided to BIOSCIENCE in Q4 2023. Upon this reduction of these amounts owed by INC to PHARMA on
January 31, 2024, the payment obligations by AG and Bioscience to INC referenced in this Section 2(b)(i) shall be deemed to be satisfied
in full. |
|
c. |
On
or before February 29, 2024, INC will pay to AG invoice AR01207 and to Bioscience invoices No TAR01584 and No.TAR01593. |
|
|
|
|
d. |
On
or before April 30, 2024, INC will pay to PHARMA the agreed upon 2023 PPV and any invoices issued by PHARMA in relation to POs #11272,
#11305, and #11154. |
|
|
i. |
These
payments shall be contingent on INC and PHARMA’s agreement on the 2023 PPV and PHARMA’s timely delivery of the products
described in POs #11272, #11305, and #11154. |
|
e. |
For
all remaining purchases of “Licensed Products” (as defined by the Agreement) by INC in 2024, INC shall make payment to
PHARMA within the standard payment term described in Section 6.1 of the Agreement. However, if INC fails to make payment in accordance
with Section 6.1 of the Agreement for any reason, INC shall pay the overdue amount to PHARMA within thirty (30) additional days,
in addition to interest calculated in accordance with Section 4.1(d) of the Agreement. |
|
|
|
|
|
For
purposes of clarification, for all remaining purchases of Licensed Products by INC in 2024, INC shall not have any rights to any
cure period provided in Section 16.3 other than as set forth in this paragraph 2(d). |
|
a. |
The
Parties agree that INC’s timely completion of payments described in the Payment Schedule will effectively satisfy the Payment
Obligations, in full. As such, so long as INC makes timely payments under the Payment Schedule, AG shall have no grounds to invoke
the provisions of Section 16.3 of the Agreement or otherwise consider INC to be in breach of the Agreement due to non-payment of
any Payment Obligations. |
|
|
|
|
|
Notwithstanding
the foregoing, any failure by INC to timely make any payments for “Licensed Products” as defined by the Agreement under
the Payment Schedule shall constitute a material breach pursuant to the Agreement and shall entitle AG to enforce any rights under
the Agreement, including any rights of termination pursuant to Section 16.3 of the Agreement, immediately upon such failure by INC
to make timely payment as defined by Section 2 of this Addendum, irrespective of any cure period provided in Section 16.3 of the
Agreement. |
|
|
|
|
b. |
This
Addendum shall only serve to supplement, amend, and/or modify the Agreement to the extent specifically provided herein. All terms,
conditions, provisions, exhibits and references of and to the Agreement that are not specifically supplemented, amended, and/or modified
herein shall remain in full force and effect and shall not be altered by any provisions herein contained. |
IN
WITNESS WHEREOF, the Parties have executed this Addendum to Amended and Restated License and Supply Agreement as of the date first set
forth above.
BIOFRONTERA
AG |
|
BIOFRONTERA
INC. |
|
|
|
|
|
BIOFRONTERA
PHARMA GmbH |
|
BIOFRONTERA
BIOSCIENCE GmbH |
|
|
|
|
|
By:
|
/s/
Pilar de la Huerta |
|
By:
|
/s/
Hermann Luebbert |
Name:
|
Pilar
de la Huerta |
|
Name: |
Hermann
Luebbert |
Title:
|
Chief
Financial Officer - Biofrontera AG |
|
Title:
|
Chief
Executive Officer |
|
Managing
Director – Biofrontera Pharma GmbH |
|
|
Managing
Director - Biofrontera Bioscience GmbH |
|
|
|
|
|
Date: |
28.01.24 |
|
Date: |
29.01.2024 |
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