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 13, 2022

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
Warrants, each warrant exercisable for one share of common stock, each at an exercise price of $5.00 per share	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 13, 2022, Biofrontera, Inc. (the “Company”) issued a press release announcing its preliminary unaudited revenue for the fourth quarter and year ended December 31, 2021. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 2.02 in the Current Report on 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 audit process, and is subject to change. The Company’s fourth quarter and full year ended December 31, 2021 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.

99.1	Press release dated January 13, 2022
104	Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

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 13, 2022 (Date)		Biofrontera Inc. (Registrant)

		/s/ Erica L. Monaco
		Erica L. Monaco Chief Executive Officer

Exhibit 99.1

Logo, company name

Description automatically generated

PRESS RELEASE

Biofrontera Inc. Announces Preliminary Revenue for the

Fourth Quarter and Full Year 2021

WOBURN, Mass., January 13, 2022 – Biofrontera Inc. (Nasdaq: BFRI) (the “Company”), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced preliminary, unaudited revenue for the quarter and full year ended December 31, 2021.

Revenue for the fourth quarter of 2021 is anticipated to be in the range of approximately $9.1 million to $9.2 million, an increase of approximately 7% over the same quarter last year.

Revenue for the full year 2021 is anticipated to be in the range of $24.1 million to $24.2 million, an increase of approximately 27% over full year 2020.

“I am proud of the hard work by our sales teams across the country. Our team has performed well during the fourth quarter, with revenue meeting our expectations,” said Erica Monaco, CEO of Biofrontera Inc. “Our performance is a testament to the strong market positioning of our portfolio products. Despite the ongoing challenges due to the COVID-19 pandemic, we have achieved a return to topline growth in 2021. We are excited about the opportunities ahead to continue building long-term value for our shareholders.”

The preliminary unaudited revenue results described in this press release are estimates only and are based only on currently available information. Our final revenue results upon completion of our closing procedures may vary from the preliminary revenue estimates. We expect to issue our full audited financial results for the fourth quarter and fiscal year 2021 in March 2022.

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 estimated revenue for the fourth quarter and year ended December 31, 2021, the performance of the Company’s sales team, the strength of the Company’s portfolio and statements relating to the future performance of the Company and opportunities for growth. 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 extraordinary external events, such as the current COVID-19 pandemic and its evolving nature; any changes in the Company’s relationship with its licensors; the outcome of the Company’s litigation with DUSA Pharmaceuticals, Inc.,; the Company’s ability to achieve and sustain profitability; whether the current disruptions in the supply chain 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 early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the studies described above will be indicative of results for any future clinical trials and studies of Ameluz® in combination with BF-RhodoLED®; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz® in combination with RhodoLED® lamps is consistent with the Company’s expectations; whether the Company will be able to successfully transition to a public company operating independently of Biofrontera AG; 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

Biofrontera Inc.

Pamela Keck

+1 781 486 1539

[email protected]

LHA Investor Relations

Tirth T. Patel

+1 212 201 6614

[email protected]

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