0001493152-23-027724.txt : 20230811 0001493152-23-027724.hdr.sgml : 20230811 20230811073035 ACCESSION NUMBER: 0001493152-23-027724 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20230811 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230811 DATE AS OF CHANGE: 20230811 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: 231161527 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): August 11, 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 August 11, 2023, Biofrontera Inc. (the “Company”) issued a press release announcing its financial and operational results for the three and six months ended June 30, 2023. 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 August 11, 2023
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.

 

August 11, 2023 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 Second Quarter 2023 Financial Results and Provides a Business Update

 

Conference call begins at 8:30 a.m. Eastern time today

 

WOBURN, Mass. (August 11, 2023) – Biofrontera Inc. (Nasdaq: BFRI) (the “Company”), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial results for the three and six months ended June 30, 2023 and provided a business update.

 

Highlights from the second quarter of 2023 and subsequent weeks included the following:

 

●Total revenues were $5.8 million, an increase of 31% from the comparable prior-year period
●Cash and cash equivalents were $4.5 million as of June 30, 2023, compared with $17.2 million as of December 31, 2022
●Equity investment in shares of Biofrontera AG were $5.9 million as of June 30, 2023
●Named Founder and Executive Chairman Hermann Luebbert as Chief Executive Officer, who continues to serve as Chairman of the Board of Directors
●Appointed life sciences industry veteran Heikki Lanckriet, Ph.D. to the Board of Directors
●A U.S. patent related to a novel photodynamic therapy (PDT) protocol that is expected to be less painful but similarly effective to conventional PDT awarded to our licensing partner
●Engaged a contract manufacturer to develop a new, low-cost portable PDT lamp for use with Ameluz® (Ameluz-PDT)
●Announced last patient out in a Phase 1 clinical study evaluating the safety and tolerability of treating AK using three tubes of Ameluz
●Announced last patient enrolled in Phase 3 clinical study evaluating Ameluz-PDT for the treatment of superficial Basal Cell Carcinoma

 

Management Commentary

 

“Biofrontera has always been a leader in innovation in PDT, and with advancements expected in multiple ongoing clinical studies for Ameluz, we are positioned for significant market expansion and revenue potential. In addition to the recent progress in ongoing clinical studies, I am proud of our team now beginning work on an early prototype of a portable PDT lamp, which has the potential not only to expand the use of Ameluz-PDT to physician offices with space limitations, but also to provide our sales force with a new selling proposition that can be easily transported and demonstrated to prospective customers,” said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera.

 

“With enhancements to our commercial strategy that range from more impactful marketing to focusing investments in higher-value sales territories, we are proud of our second quarter financial results as product revenues grew by 31% over the prior year,” added Fred Leffler, Chief Financial Officer of Biofrontera Inc. “Our business is tracking well against our expectations and we are affirming guidance for 2023 revenue growth of at least 25% compared with 2022.”

 

 

 

 

Second Quarter Financial Results

 

Total revenues for the second quarter of 2023 were $5.8 million, an increase of $1.4 million, or 31%, compared with $4.5 million for the second quarter of 2022. This growth reflects higher sales of Ameluz due to a sales force expansion, increased adoption by dermatologists and the absence of a buy-in impact due to a price increase.

 

Total operating expenses were $14.5 million for the second quarter of 2023 compared with $10.7 million for the second quarter of 2022. Cost of revenues  was $2.9 million for the second quarter of 2023 compared with $2.6 million for the prior-year quarter, driven by higher Ameluz product revenue. Selling, general and administrative expenses  were $11.5 million for the second quarter of 2023 compared with $10.0 million for the second quarter of 2022, with the increase primarily due to higher personnel costs, mostly related to severance payments due to a realignment of the work force.

 

The net loss for the second quarter of 2023 was $9.8 million, or $(7.23) per share, compared with a net loss of $850,000, or $(0.90) per share, for the prior-year quarter, all on a post-split basis.

 

Adjusted EBITDA for the second quarter of 2023 was negative $7.9 million compared with negative $7.1 million for the second quarter of 2022, reflecting higher SG&A costs partially offset by increased revenues. Adjusted EBITDA, a non-GAAP financial measure, 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.

 

Six Month Financial Results

 

Total revenues were $14.6 million for the first half of 2023 compared with $14.2 million for the first half of 2022. The increase was primarily driven by a higher volume of Ameluz sales due to the sales team expansion, a higher average Ameluz selling price and a higher volume of RhodoLED® lamp sales. The increase is remarkable as it was achieved in the absence of the stocking effect of a price increase as in the previous year.

 

Total operating expenses were $28.8 million for the first half of 2023 compared with $23.5 million for the first half of 2022. Cost of revenues  decreased slightly from the prior year to $7.5 million for the first six months of 2023. Selling, general and administrative expenses increased by 21 % compared with the prior year, primarily due to higher legal expenses and headcount.

 

The net loss for the first half of 2023 was $17.3 million, or $(12.73) per share, compared with net income of $4.7 million, or $5.22 per diluted share, for the first half of 2022.

 

Adjusted EBITDA was negative $11.9 million for the first half of 2023 compared with negative $9.5 million for the first half of 2022.

 

 

 

 

The below table presents a reconciliation from net income (loss) to Adjusted EBITDA for the three and six months ended June 30, 2023 and 2022:

 

  

Three months ended

June 30,

  

Six months ended

June 30,

 
   2023   2022   2023   2022 
Net income (loss)  $(9,837)  $(850)  $(17,315)  $4,711 
Interest expense, net   79    38    114    71 
Income tax expense   14    -    20    30 
Depreciation and amortization   253    132    518    263 
EBITDA   (9,491)   (680)   (16,663)   5,075 
Change in fair value of contingent consideration   100    (1,900)   (100)   (1,900)
Change in fair value of warrant liabilities   (375)   (5,371)   (1,403)   (14,082)
Change in fair value of investment, related party   1,482    -    4,424    - 
Legal settlement expenses   107    261    1,225    313 
Stock compensation expense   259    551    610    1,068 
Adjusted EBITDA  $(7,918)  $(7,139)  $(11,907)  $(9,526)
Adjusted EBITDA margin   -135.4%   -160.2%   -81.7%   -67.0%

 

As of June 30, 2023, Biofrontera had cash and cash equivalents of $4.5 million compared with $17.2 million as of December 31, 2022. In addition, the Company had a $5.9 million investment in shares of Biofrontera AG as of June 30, 2023.

 

Financial Expectations

 

Biofrontera Inc. affirms expectations for full-year 2023 growth in revenue to be at least 25% compared with 2022, and expects to be cash flow positive within approximately one and a half years.

 

Conference Call and Webcast

 

Biofrontera Inc. will hold a conference call today at 8:30 a.m. Eastern time to discuss these results and answer questions.

 

  Date: Friday, August 11, 2023
  Time: 8:30 a.m. Eastern time
  Conference Call: 1-877-877-1275 (U.S. toll-free)
    1-412-858-5202 (international)
  Webcast: Live and 90-day replay webcast are available here and at investors.biofrontera-us.com.

 

 

 

 

About Biofrontera Inc.

 

Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical 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”) 2023 revenue guidance, clinical trials for Ameluz® and potential for label expansion, improved market opportunities, the potential impact of developing new PDT lamp prototypes and the impact of enhancements to sales strategy. 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 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

 

(Tables follow)

 

 

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value and share amounts)

 

   June 30, 2023   December 31, 2022 
   (Unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents  $4,453   $17,208 
Investment, related party   5,935    10,548 
Accounts receivable, net   2,193    3,748 
Other receivables, related party   4,001    3,658 
Inventories   14,785    7,168 
Prepaid expenses and other current assets   929    810 
           
Total current assets   32,296    43,140 
           
Other receivables long term, related party   -    2,813 
Property and equipment, net   175    204 
Operating lease right-of-use assets   1,107    1,375 
Intangible asset, net   2,823    3,032 
Other assets   504    320 
           
Total assets  $36,905   $50,884 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable   1,243    1,278 
Accounts payable, related parties   4,657    1,312 
Acquisition contract liabilities, net   7,121    6,942 
Operating lease liabilities   489    498 
Accrued expenses and other current liabilities   10,736    10,864 
Line of credit   1,106    - 
           
Total current liabilities   25,352    20,894 
           
Long-term liabilities:          
Acquisition contract liabilities, net   2,300    2,400 
Warrant liabilities   1,440    2,843 
Operating lease liabilities, non-current   600    848 
Other liabilities   40    21 
           
Total liabilities   29,732    27,006 
           
Commitments and contingencies (Note 18)          
           
Stockholders’ equity:          
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of June 30, 2023 and December 31, 2022   -    - 
Common Stock, $0.001 par value, 15,000,000 shares authorized; 1,367,628 and 1,359,040 shares issued and outstanding as of June 30, 2023 and December 31, 2022   27    27 
Additional paid-in capital   103,980    103,370 
Accumulated deficit   (96,834)   (79,519)
           
Total stockholders’ equity   7,173    23,878 
           
Total liabilities and stockholders’ equity  $36,905   $50,884 

 

 

 

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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

(Unaudited)

 

   Three months ended June 30,   Six months ended June 30, 
   2023   2022   2023   2022 
                 
Product revenues, net  $5,830   $4,441   $14,544   $14,177 
Revenues, related party   18    16    36    31 
                     
Total revenues, net   5,848    4,457    14,580    14,208 
                     
Operating expenses                    
Cost of revenues, related party   2,772    2,402    7,319    7,377 
Cost of revenues, other   116    152    167    327 
Selling, general and administrative   11,456    9,669    21,254    17,285 
Selling, general and administrative, related party   92    346    119    441 
Research and development   11    -    11    - 
Change in fair value of contingent consideration   100    (1,900)   (100)   (1,900)
                     
Total operating expenses   14,547    10,669    28,770    23,530 
                     
Loss from operations   (8,699)   (6,212)   (14,190)   (9,322)
                     
Other income (expense)                    
Change in fair value of warrants   375    5,371    1,403    14,082 
Change in fair value of investment, related party   (1,482)   -    (4,424)   - 
Interest expense, net   (79)   (38)   (114)   (71)
Other income, net   62    29    30    52 
                     
Total other income (expense)   (1,124)   5,362    (3,105)   14,063 
                     
Income (loss) before income taxes   (9,823)   (850)   (17,295)   4,741 
Income tax expense   14    -    20    30 
                     
Net income (loss)  $(9,837)  $(850)  $(17,315)  $4,711 
                     
Income (loss) per common share:                    
Basic  $(7.23)  $(0.90)  $(12.73)  $5.24 
Diluted  $(7.23)  $(0.90)  $(12.73)  $5.22 
                     
Weighted-average common shares outstanding:                    
Basic   1,360,739    941,175    1,359,894    898,444 
Diluted   1,360,739    941,175    1,359,894    902,209 

 

# # #

 

 

 

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Cover
Aug. 11, 2023
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 11, 2023
Entity File Number 001-40943
Entity Registrant Name Biofrontera Inc.
Entity Central Index Key 0001858685
Entity Tax Identification Number 47-3765675
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 120 Presidential Way
Entity Address, Address Line Two Suite 330
Entity Address, City or Town Woburn
Entity Address, State or Province MA
Entity Address, Postal Zip Code 01801
City Area Code (781)
Local Phone Number 245-1325
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
Entity Information, Former Legal or Registered Name Not Applicable
Common stock, par value $0.001 per share  
Title of 12(b) Security Common stock, par value $0.001 per share
Trading Symbol BFRI
Security Exchange Name NASDAQ
Preferred Stock Purchase Rights  
Title of 12(b) Security Preferred Stock Purchase Rights
Security Exchange Name NASDAQ
Warrants to purchase common stock  
Title of 12(b) Security Warrants to purchase common stock
Trading Symbol BFRIW
Security Exchange Name NASDAQ
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