0001493152-24-020031.txt : 20240515 0001493152-24-020031.hdr.sgml : 20240515 20240515172046 ACCESSION NUMBER: 0001493152-24-020031 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240515 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240515 DATE AS OF CHANGE: 20240515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Biofrontera Inc. CENTRAL INDEX KEY: 0001858685 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences 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: 24952627 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): May 15, 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 May 15, 2024, Biofrontera Inc. (the “Company”) issued a press release announcing its financial and operational results for the three months ended March 31, 2024. A copy of the press release is being furnished as Exhibit 99.1 attached hereto to this Current Report on Form 8-K.

 

The Company’s press release contains non-GAAP financial measures. Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with United States generally accepted accounting principles, or GAAP. Pursuant to the requirements of Regulation G, the Company has provided within the press release quantitative reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures.

 

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.

 

Item 9.01 Financial Statements and Exhibits.

 

99.1   Press release dated May 15, 2024
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.

 

May 15, 2024 Biofrontera Inc.
(Date) (Registrant)
   
  /s/ E. Fred Leffler III
  E. Fred Leffler, III
  Chief Financial Officer

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

Biofrontera Inc. Reports First Quarter 2024 Financial Results and Provides a Business Update

 

Conference call begins at 10:00 a.m. Eastern time on Thursday, May16, 2024

 

WOBURN, MA / ACCESSWIRE / May 15, 2024 / Biofrontera Inc. (Nasdaq:BFRI) (the “Company”), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial results for the three months ended March 31, 2024 and provided a business update.

 

Highlights from the first quarter of 2024 and subsequent weeks included the following:

 

●Total revenues for the first quarter of 2024 were $7.9 million, a 9% decrease from the same period of the prior year primarily driven by reimbursement headwinds our customers experienced due to the Change Healthcare data breach
●Cash and cash equivalents were $3.8 million as of March 31, 2024, compared with $1.3 million on December 31, 2023
●The Company completed a private placement of preferred stock with healthcare focused institutional investors for gross proceeds of $8 million
●Met operational and commercial milestones to secure an additional $8 million through the exercise of warrants in connection with the private placement mentioned above
●Renegotiated the Ameluz® license and supply agreement (LSA) to reduce the transfer price of Ameluz® for 2024 and 2025 from 40 - 50% to 25%, stepping up to 35% by 2032 for Ameluz® prescribed in actinic keratosis and non-melanoma skin cancer indications; product costs associated with any acne indication will be 25% indefinitely
●In connection with the LSA amendment, the Company will take over the management and costs of US clinical trials relating to Ameluz on June 1st, 2024, allowing more direct control and cost management
●The Company anticipates that sales of its new RhodoLED XL® lamp will begin in the second quarter of 2024
●U.S. Food and Drug Administration (FDA) issued a “no filing review issues identified” letter regarding the supplementary New Drug Application submitted by our Ameluz licensor Biofrontera Bioscience GmbH to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. We expect a final decision from the FDA on or around October 4, 2024

 

Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated, “Although we are disappointed with the decrease in sales during the quarter compared to the same period in 2023, we believe general healthcare reimbursement issues affecting the entire industry were a major factor. Our team continues to work with insurers and medical providers to help minimize these challenges. As we have already announced, we have managed to make up the sales shortage and as of April 30th our 2024 YTD revenue growth is over 5%.”

 

“We have focused much of our efforts over the last year on developing new accounts and in the first quarter of this year we placed 29 BF-RhodoLED® lamps, an increase of 123% over 1Q 2023, illustrating the need and demand we continue to experience. We are also looking forward to June 1, 2024, when under the amended LSA we will take control of all clinical trials relating to Ameluz® ® in the US, allowing for more effective cost management and direct oversight of trial efficiency. The reduced transfer price will allow us to finance R&D activities and continue our commercial growth trajectory,” concluded Mr. Luebbert.

 

 
 

 

First Quarter Financial Results

 

Total revenues for the first quarter of 2024 were $7.9 million compared with $8.7 million for the first quarter of 2023. The decrease is due in part to healthcare reimbursement challenges caused by the Change Healthcare data breach that created cash challenges for the entire health care industry throughout the quarter.

 

Total operating expenses were $13.4 million for the first quarter of 2024 compared with $14.2 million for the first quarter of 2023. Cost of revenues was $4.1 million for the first quarter of 2024 compared with $4.6 million for the prior-year quarter, with the decline driven by lower sales. Selling, general and administrative expenses were $9.3 million for the first quarter of 2024 compared with $9.8 million for the first quarter of 2023. The decrease was primarily driven by a $1.1 million decrease in non-recurring legal costs and a decrease of sales and marketing expenses of $0.3 million. The decrease was primarily offset by a $0.7 million increase in fees and issuance costs as well as a small increase in personnel expenses.

 

The net loss for the first quarter of 2024 was $10.4 million, or $(2.88) per share, compared with a net loss of $7.5 million, or $(5.60) per share, for the prior-year quarter. The change in net loss was driven by the revaluation of the B-3 Preferred Warrants, a non-cash adjustment, along with lower-than-expected sales.

 

Adjusted EBITDA for the first quarter of 2024 was negative $4.6 million compared with negative $4.1 million for the first quarter of 2023, reflecting lower revenues for the first quarter of 2024. We look at Adjusted EBITDA, a non-GAAP financial measure, as a better indication of ongoing operations and this measurement is defined as net income or loss excluding interest income and expense, income taxes, depreciation and amortization, and certain other non-recurring or non-cash items.

 

Please refer to the table below which presents a GAAP to non- GAAP reconciliation of Adjusted EBITDA for the first quarters of 2024 and 2023.

 

Conference Call Details

 

Conference call: Thursday, May 16, 2024 at 10:00 AM ET

Toll Free: 1-888-222-5806 (U.S. toll-free)

International: 1-412-902-6516

Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=XHBE0SOB

 

 
 

 

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 and follow Biofrontera on LinkedIn and Twitter.

 

Contacts

 

Investor Relations

Andrew Barwicki

1-516-662-9461

ir@bfri.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. These statements include, but are not limited to, statements relating to the Company’s revenue guidance, business and marketing strategy, revenue growth, development and expansion of the Company’s sales force and commercial infrastructure, sales force productivity, growth strategy, liquidity and cash flow, potential to expand the label of Ameluz®, available market opportunities for Ameluz®, ongoing clinical trials, educational outreach efforts, and other statements that are not historical facts. The words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “target”, “goal”, “assume”, “would”, “could” or similar words are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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, include, but are not limited to, our reliance on sales of products we license from other companies as our sole source of revenue; the success of our competitors in developing generic topical dermatological products that successfully compete with our licensed products; the success of our principal licensed product, Ameluz; the ability of the Company’s licensors to establish and maintain relationships with contract manufacturers that are able to supply the Company with enough of the licensed products to meet our demand; the ability of our licensors or their manufacturing partners to supply the licensed products that we market in sufficient quantities and at acceptable quality and cost levels, and to fully comply with current good manufacturing practice or other applicable manufacturing regulations; the ability of our Licensors to successfully defend or enforce patents related to our licensed products; the availability of insurance coverage and medical expense reimbursement for our licensed products; the impact of legislative and regulatory changes; competition from other pharmaceutical and medical device companies and existing treatments, such as simple curettage and cryotherapy; the Company’s ability to achieve and sustain profitability; the Company’s ability to obtain additional financing as needed to implement its growth strategy; the effect of the COVID-19 global pandemic; the Company’s ability to retain and hire key personnel; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (“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 undertake 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.

 

(Tables follow)

 

 
 

 

BIOFRONTERA INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value and share amounts)

 

   March 31,
2024		   December 31,
2023		 
   (Unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents  $3,817   $1,343 
Investment, related party   23    78 
Accounts receivable, net   3,520    5,162 
Other receivables, related party   171    - 
Inventories, net   6,905    10,908 
Prepaid expenses and other current assets   560    425 
Other assets, related party   5,159    5,159 
           
Total current assets   20,155    23,075 
           
Property and equipment, net   120    134 
Operating lease right-of-use assets   1,416    1,612 
Intangible asset, net   2,556    2,629 
Other assets   328    482 
           
Total assets  $24,575   $27,932 
           
LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable   2,717    3,308 
Accounts payable, related parties   4,044    5,698 
Operating lease liabilities   690    691 
Accrued expenses and other current liabilities   4,230    4,487 
Short term debt   2,355    3,904 
           
Total current liabilities   14,036    18,088 
           
Long-term liabilities:          
Warrant liabilities   11,731    4,210 
Operating lease liabilities, non-current   621    804 
Other liabilities   33    37 
           
Total liabilities   26,421    23,139 
           
Commitments and contingencies (Note 17)          
           
Mezzanine equity:          
Series B-1 Convertible Preferred Stock, $0.001 par value, 6,586 share authorized, 4,806 and zero shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively   3,570    - 
Series B-2 Convertible Preferred Stock, $0.001 par value, 6,586 shares authorized, zero shares issued and outstanding as of March 31, 2024 and December 31, 2023   -    - 
Series B-3 Convertible Preferred Stock, $0.001 par value, 8,000 shares authorized, zero shares issued and outstanding as of March 31, 2024 and December 31, 2023   -    - 
           
Stockholders’ equity:          
Preferred Stock, $0.001 par value, 19,978,828 shares authorized, zero shares issued and outstanding as of March 31, 2024 and December 31, 2023   -    - 
Common Stock, $0.001 par value, 15,000,000 shares authorized; 5,089,413 and 1,517,628 shares issued and outstanding as of March 31, 2024 and December 31, 2023   5    2 
Additional paid-in capital   104,666    104,441 
Accumulated deficit   (110,087)   (99,650 
           
Total stockholders’ equity   (5,416)   4,793 
           
Total liabilities, mezzanine equity and stockholders’ equity  $24,575   $27,932 

 

 
 

 

BIOFRONTERA INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts and number of shares)

(Unaudited)

 

   Three Months Ended March 31, 
   2024   2023 
         
Products revenues, net  $7,901   $8,715 
Revenues, related party   11    18 
           
Total revenues, net   7,912    8,733 
           
Operating expenses          
Cost of revenues, related party   3,946    4,547 
Cost of revenues, other   170    51 
           
Selling, general and administrative   9,250    9,800 
Selling, general and administrative, related party   (4)   27 
           
Research and development   17    - 
Change in fair value of contingent consideration   -    (200)
           
Total operating expenses   13,379    14,225 
           
Loss from operations   (5,467)   (5,492)
           
Other income (expense)          
Change in fair value of warrant liabilities   (3,429)   1,028 
Change in fair value of investment, related party   3    (2,941)
Loss on debt extinguishment   (316)   - 
Interest expense, net   (1,407)   (35)
Other income (expense), net   180    (33)
           
Total other income (expense)   (4,969)   (1,981)
           
Loss before income taxes   (10,436)   (7,473)
Income tax expense   1    5 
           
Net loss  $(10,437)  $(7,478)
           
Loss per common share:          
Basic and diluted  $(2.88)  $(5.60)
           
Weighted-average common shares outstanding:          
Basic and diluted   3,623,593    1,334,950 

 

 
 

 

BIOFRONTERA INC.

GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION

(In thousands, except per share amounts and number of shares)

(Unaudited)

 

   Three Months Ended March 31, 
   2024   2023 
Net loss  $(10,437)  $(7,478)
Interest expense, net   1,407    35 
Income tax expenses   1    5 
Depreciation and amortization   128    127 
EBITDA   (8,901)   (7,311)
           
Loss on debt extinguishment   316    - 
Change in fair value of contingent consideration   -    (200)
Change in fair value of warrant liabilities   3,429    (1,028)
Change in fair value of investment, related party   (3)   2,941 
Legal settlement expenses   -    1,118 
Stock based compensation   228    351 
Expensed issuance costs   354    - 
Adjusted EBITDA  $(4,577)  $(4,129)
Adjusted EBITDA margin   -57.9%   -47.3%

 

#     #      #

 

 

 

 

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