0001493152-22-019081.txt : 20220712 0001493152-22-019081.hdr.sgml : 20220712 20220712161331 ACCESSION NUMBER: 0001493152-22-019081 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20220712 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220712 DATE AS OF CHANGE: 20220712 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Biofrontera Inc. CENTRAL INDEX KEY: 0001858685 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 473765675 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40943 FILM NUMBER: 221079296 BUSINESS ADDRESS: STREET 1: 120 PRESIDENTIAL WAY, STREET 2: SUITE 330 CITY: WOBURN STATE: MA ZIP: 01801 BUSINESS PHONE: 781-245-1325 MAIL ADDRESS: STREET 1: 120 PRESIDENTIAL WAY, STREET 2: SUITE 330 CITY: WOBURN STATE: MA ZIP: 01801 8-K 1 form8-k.htm
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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 12, 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 July 12, 2022, Biofrontera, Inc. (the “Company”) issued a press release announcing its preliminary unaudited product revenues for the six and three months ended June 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 six and three months ended June 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 July 12, 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.

 

July 12, 2022 Biofrontera Inc.
(Date) (Registrant)
   
 

/s/ Erica L. Monaco

  Erica L. Monaco
  Chief Executive Officer

 

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

PRESS RELEASE

 

Biofrontera Inc. Announces Preliminary Product Revenues for the Second

Quarter of 2022

 

WOBURN, Mass. (July 12, 2022) – Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today preliminary unaudited product revenues for the six and three months ended June 30, 2022.

 

For the first half of 2022, product revenues are anticipated to be in the range of approximately $14.1 million to $14.3 million, representing an increase of approximately 34% to 36% compared with the first half of 2021. This represents the strongest first six-month revenues of a year Biofrontera ever had, 102-105% higher than in 2020 and 22-24% higher than the pre-Covid year 2019.

 

As anticipated because of the effect of a price increase, product revenues for the second quarter of 2022 are expected to be in the range of approximately $4.4 million to $4.6 million, representing a decrease of approximately 21% to 25% compared with the second quarter of 2021.

 

“I’m proud of the performance by our sales team as we continue to expand awareness of Ameluz®, achieve deeper penetration among current customer accounts and drive sales for the brand. Second quarter product revenues reflect the April 1, 2022 price increase that resulted in some advance purchases of Ameluz in the first quarter,” commented Erica Monaco, Chief Executive Officer of Biofrontera Inc. “Despite the expected year-over-year quarterly decline, year-to-date product revenues increased. We continue to execute toward upcoming clinical milestones and remain on track with previously-announced financial guidance for 2022 total revenues to increase by at least 30% compared with 2021, including typical seasonal strength in the first and fourth quarters.”

 

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 second quarter of 2022 in August 2022. 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.

 

1

 

 

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 the Company’s business and marketing strategy, future operations and business, potential to expand the label of Ameluz®, market presence and position of Ameluz® and ongoing clinical trials conducted by our licensing partners and the future impact of such trials on the market for 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

us-ir@biofrontera.com

 

LHA Investor Relations

 

Tirth T. Patel

+1 212 201 6614

tpatel@lhai.com

 

# # #

 

2

 

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