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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): October 5, 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 October 5, 2022, Biofrontera, Inc. (the “Company”) issued a press release announcing its preliminary unaudited product revenues for the nine and three months ended September 30, 2022. 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 product revenue estimates, is subject to the completion of its review process, and is subject to change. The Company’s nine and three months ended September 30, 2022 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 October 5, 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.

 

October 5, 2022 Biofrontera Inc.
(Date) (Registrant)
   
 

/s/ Erica L. Monaco

  Erica L. Monaco
  Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

PRESS RELEASE

 

Biofrontera Inc. Announces Preliminary Product Revenues for the Third Quarter of 2022

 

WOBURN, Mass. (October 5, 2022) – Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced preliminary unaudited product revenues for the three and nine months ended September 30, 2022.

 

Product revenues for the third quarter of 2022 are anticipated to be approximately $4.3 million, consistent with the third quarter of 2021. These projections result in product revenues for the first nine months of 2022 expected to be approximately $18.5 million up approximately 24% compared with the first nine months of 2021. Year-to-date 2022 product revenues are at a record high, and are up approximately 26% over the comparable period in the pre-Covid year 2019.

 

“Our work to increase adoption of photodynamic therapy (PDT) for the treatment of actinic keratosis (AK) continued during the third quarter, which historically is the seasonally softest sales quarter of the year. Importantly, we remain on track to achieve our guidance for 2022 total revenues to increase by at least 30% compared with 2021 as we achieve deeper sales penetration among current customer accounts,” stated Erica Monaco, Chief Executive Officer of Biofrontera Inc.

 

“Our sales and marketing teams have recently been recognized with multiple awards and accolades, and we’re proud of the impact they’re having on patient health,” she added. “We look forward to elevating Biofrontera’s brand among dermatologists through label expansion and marketing to capture the potential of Ameluz®.”

 

The preliminary unaudited product revenues described in this press release are estimates only and are based on currently available information. Final results may vary from the preliminary product revenues estimates. Biofrontera expects to report financial results for the third quarter of 2022 in the first half of November 2022. Details concerning that announcement and conference call will be provided in the coming weeks.

 

About Biofrontera Inc.

 

Biofrontera Inc. (the “Company”) 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.

 

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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 product revenues for the three and nine months ended September 30, 2022, the Company’s financial guidance for 2022, increases in the adoption of PDT, statements relating to the Company’s expectations for its business and marketing strategy, the ability of the Company’s sales and marketing teams to increase sales to current customer accounts 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 extraordinary external events, such as the current COVID-19 pandemic; 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 complete the transition to a public company; 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.

Anke zur Mühlen

+1 781 486 1539

[email protected]

 

LHA Investor Relations

Tirth T. Patel

+1 212 201 6614

[email protected]

 

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