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January 11 2024 - 4:40PM
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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 11, 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
2.02 Results of Operations and Financial Condition.
On
January 11, 2024 Biofrontera Inc. (the “Company”) issued a press release announcing its preliminary unaudited revenues for
the fourth quarter and full year ended December 31, 2023. A copy of the press release is being furnished as Exhibit 99.1 to this Current
Report on Form 8-K (the “Form 8-K”) and is incorporated herein by reference.
The
information contained in this Item 2.02 in this 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 liability of that section, nor shall such information be deemed to be incorporated by reference in any registration
statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by
specific reference in such filing.
The
financial information set forth in this Form 8-K reflects the Company’s current preliminary revenue estimates, is subject to the
completion of its review process, and is subject to change. The Company’s fourth quarter results could differ materially from the
preliminary estimates provided in this Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which
reflect management’s analysis only as of the date of this Form 8-K. The Company undertakes no obligation to publicly release the
results of any revision or update of the forward-looking statements, except as required by law.
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.
January
11, 2024
|
|
Biofrontera
Inc.
|
(Date) |
|
(Registrant) |
|
|
|
|
|
/s/
E. Fred Leffler III |
|
|
E.
Fred Leffler III |
|
|
Chief
Financial Officer |
Exhibit
99.1
Biofrontera
Inc. Announces Preliminary Revenues for the Fourth Quarter and Full Year 2023
January
11, 2024 / Biofrontera Inc. (Nasdaq:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological
products, today announced preliminary, unaudited revenues for the three and twelve months ended December 31, 2023.
Biofrontera
achieved 2023 revenue of approximately $33.8 million to $34.3 million, a record high and up approximately 19% growth compared with 2022.
Revenues for the fourth quarter of 2023 are anticipated to be in the range of approximately $10.4 million to $10.9 million, an increase
of approximately 5% compared with the fourth quarter of 2022. After a slow start in the first quarter of the year, Biofrontera grew revenues
significantly over the following quarters. Sales increased strongly between 34% and 37% in the second half of the year compared to the
prior year. The very strong growth in the third quarter was supported by a price increase on October 1 and some buy-in of customers.
While our fourth quarter sales grew a little less than expected from that, we could still maintain the growth trajectory in the quarter,
resulting in our solid second half year growth.
The
preliminary, unaudited revenues described in this press release are estimates only and are based on currently available information.
Final results may vary from the preliminary revenue estimates. Biofrontera expects to report financial results for the fourth quarter
and full year 2023 in March 2024. Details concerning that announcement and conference call will be provided in the coming weeks.
About
Biofrontera Inc.
Biofrontera
Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological
conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the
treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information,
visit www.biofrontera-us.com.
Forward-Looking
Statements
Certain
statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private
Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, the Company’s preliminary
revenues for the three and twelve months ended December 31, 2023, statements relating to the Company’s business and marketing strategy,
the development of the Company’s sales and marketing teams and the potential to expand the label of Ameluz®. We have based
these forward-looking statements on our current expectations and projections about future events, nevertheless, actual results or events
could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make.
These risks and uncertainties, many of which are beyond our control, including, but not limited to, the impact of any extraordinary external
events; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their
obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current
global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in
the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s
licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from
clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED® in different
disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with
regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz® in combination
with BF-RhodoLED® is consistent with the Company’s expectations; the Company’s ability to comply with public company
requirements; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional
financing and other factors that may be disclosed in the Company’s filings with the SEC, which can be obtained on the SEC website
at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the
date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does
not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press
release except as required by law.
Contacts:
Barwicki
Investor Relations
Andrew
Barwicki
516-662-9461
andrew@barwicki.com
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