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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): July 13, 2023
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
July 12, 2023, Biofrontera, Inc. (the “Company”) issued a press release announcing its preliminary unaudited revenues for
the three and six months ended June 30, 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 second 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.
July
13, 2023
(Date) |
Biofrontera
Inc.
(Registrant) |
|
|
|
/s/
E. Fred Leffler III |
|
E. Fred Leffler III |
|
Chief Financial Officer |
Exhibit
99.1
Biofrontera
Inc. Announces Preliminary Second Quarter Revenues are Up 26% to 31%
Management Reaffirms Full-Year 2023 Revenue
Growth of at least 25% over Prior Year
WOBURN,
Mass. (July 13, 2023) – Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a
biopharmaceutical company specializing in the commercialization of dermatologic products, today announced preliminary unaudited revenues
for the three months ended June 30, 2023.
Revenues
for the second quarter of 2023 are anticipated to be in the range of approximately $5.7 million to $5.9 million, an increase of approximately
26% to 31% compared with the second quarter of 2022. As a result, revenues for the first half of 2023 are anticipated to be in the range
of approximately $14.4 million to $14.6 million, representing growth of approximately 1% to 3% compared with the first half of 2022.
“We
are proud of the hard work of our commercial teams, which resulted in year-over-year revenue growth without the benefit of a price increase
for Ameluz® as we had in 2022. The revenue trends and record-high second quarter results reflect increasing adoption among
dermatologists of photodynamic therapy for the field treatment of actinic keratosis. Of note, our sales force has been successful in
securing larger contracts, which will help make our quarterly financial results more predictable. New hires have performed admirably
well while the balance of our maturing salesforce is executing to plan,” said Hermann Luebbert, Chief Executive Officer and Chairman
of Biofrontera Inc.
Biofrontera
Inc. affirms its previously announced expectations for full-year 2023 growth in revenue to be at least 25% compared with 2022.
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 Inc. expects to report financial results for the second quarter
of 2023 in August 2023. 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 products for the treatment of dermatologic 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
and follow Biofrontera on LinkedIn and Twitter.
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, statements relating to
Biofrontera Inc.’s (the “Company”) preliminary revenues for the three and six months ended June 30, 2023, expectations
for revenue growth in 2023, the adoption of PDT for the treatment of actinic keratoses by dermatologists, the achievements of our
salesforce and the performance of the Company’s new hires. 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 regain compliance with Nasdaq continued listing standards, 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.
Contact:
LHA
Investor Relations
Tirth
T. Patel
212-201-6614
tpatel@lhai.com
#
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Biofrontera (NASDAQ:BFRI)
過去 株価チャート
から 8 2024 まで 9 2024
Biofrontera (NASDAQ:BFRI)
過去 株価チャート
から 9 2023 まで 9 2024