UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 10-Q

 

 

 

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 20222023

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from               to

 

Commission file number 001-40943

 

 

Biofrontera Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware 47-3765675

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

   
120 PresentialPresidential Way, Suite 330, Woburn, Massachusetts 01801
(Address of principal executive offices) (Zip Code)

 

(781) 245-1325

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

 

 

Securities registered pursuant to Section 12(b) of the 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 RightsThe 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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
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.

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

 

As of May 12, 2022,11, 2023 there were 17,104,74926,699,002, shares outstanding of the registrant’s common stock, par value $0.001 per share.

 

 

 

 
 

 

TABLE OF CONTENTS

 

 PART 1. FINANCIAL INFORMATION 
   
ITEM 1.Financial Statements (Unaudited) 
 Consolidated Balance Sheets as of March 31, 20222023 (unaudited) and December 31, 202120223
Consolidated Statements of Operations for the three months ended March 31, 2023 (unaudited) and 2022 and 2021(unaudited)4
Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2023 (unaudited) and 2022 and 2021(unaudited)5
Consolidated Statements of Cash Flows for the three months ended March 31, 2023 (unaudited) and 2022 and 2021(unaudited)6
Notes to Consolidated Financial Statements7
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations20
ITEM 3.Quantitative and Qualitative Disclosures About Market Risk3129
ITEM 4.Controls and Procedures3129
 
PART II. OTHER INFORMATION 
 PART II. OTHER INFORMATION
 
ITEM 1.Legal Proceedings3230
ITEM 1A.Risk Factors3230
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds3230
ITEM 3.Defaults Upon Senior Securities3230
ITEM 4.Mine Safety Disclosures3230
ITEM 5.Other Information3230
ITEM 6.Exhibits3331
Signatures3432

 

2
 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

BIOFRONTERA INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except par value and share amounts)

 

 March 31, 2022  

December 31, 2021

 
 (Unaudited)     March 31, 2023  December 31, 2022 
       (Unaudited)    
ASSETS                
Current assets:                
Cash and cash equivalents $22,428  $24,545  $13,505  $17,208 
Investment in equity securities  7,596   10,548 
Accounts receivable, net  5,172   3,784   4,116   3,748 
Other receivables, related party  8,686   8,647   3,750   3,658 
Inventories  4,872   4,458   6,670   7,168 
Prepaid expenses and other current assets  1,373   4,987   1,586   810 
                
Total current assets  42,531   46,421   37,223   43,140 
                
Other receivables long term, related party  2,813   2,813   -   2,813 
Property and equipment, net  245   267   197   204 
Operating lease right-of-use assets  1,234   1,375 
Intangible asset, net  3,345   3,450   2,927   3,032 
Other assets  268   268   384   320 
                
Total assets $49,202  $53,219  $41,965  $50,884 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable $302  $658   887   1,278 
Accounts payable, related parties  269   282   912   1,312 
Acquisition contract liabilities, net  3,242   3,242   7,032   6,942 
Operating lease liabilities  484   498 
Accrued expenses and other current liabilities  8,546   9,654   11,135   10,864 
                
Total current liabilities  12,359   13,836   20,450   20,894 
                
Long-term liabilities:                
Acquisition contract liabilities, net  9,632   9,542   2,200   2,400 
Warrant liability  4,143   12,854 
Warrant liabilities  1,815   2,843 
Operating lease liabilities, non-current  725   848 
Other liabilities  5,652   5,649   24   21 
                
Total liabilities $31,786  $41,881   25,214   27,006 
                
Commitments and contingencies (see Note 23)  -     
Commitments and contingencies (see Note 21)  -   - 
                
Stockholders’ equity:                
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, 0 shares issued and outstanding as of March 31, 2022 and December 31, 2021 $-  $- 
Common Stock, $0.001 par value, 300,000,000 shares authorized; 17,104,749 shares issued and outstanding as of March 31, 2022 and December 31, 2021 17  17 
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of March 31, 2023 and December 31, 2022  -   - 
Common Stock, $0.001 par value, 300,000,000 shares authorized; 26,699,002 shares issued and outstanding as of March 31, 2023 and December 31, 2022  27   27 
Additional paid-in capital  90,717   90,200   103,721   103,370 
Accumulated deficit  (73,318)  (78,879)  (86,997)  (79,519)
                
Total stockholders’ equity  17,416   11,338   16,751   23,878 
                
Total liabilities and stockholders’ equity $49,202  $53,219  $41,965  $50,884 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

3
 

BIOFRONTERA INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

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

(Unaudited)

 2022 2021  2023  2022 
 Three Months Ended March 31,  

Three Months Ended

March 31,

 
 2022 2021  2023  2022 
          
Products revenues, net $9,736  $4,731  $8,715  $9,736 
Revenues, related party  15   13   18   15 
                
Total revenues, net  9,751   4,744   8,733   9,751 
                
Operating expenses                
Cost of revenues, related party  4,975   2,408   4,547   4,975 
Cost of revenues, other  175   163   51   175 
Selling, general and administrative  7,616   4,758   9,800   7,616 
Selling, general and administrative, related party  95   164   27   95 
Restructuring costs  -   281 
Change in fair value of contingent consideration  -   498   (200)  - 
                
Total operating expenses  12,861   8,272   14,225   12,861 
                
Loss from operations  (3,110)  (3,528)  (5,492)  (3,110)
                
Other income (expense)                
Change in fair value of warrant liabilities  8,711   -   1,028   8,711 
Change in fair value of investments  (2,941)  - 
Interest expense, net  (33)  (84)  (35)  (33)
Other income, net  23   79 
Other income (expense), net  (33)  23 
                
Total other income (expense)  8,701   (5)  (1,981)  8,701 
                
Income (loss) before income taxes  5,591   (3,533)  (7,473)  5,591 
Income tax expense  30   1   5   30 
                
Net income (loss) $5,561  $(3,534) $(7,478) $5,561 
                
Income (loss) per common share:                
Basic $0.33  $(0.44) $(0.28) $0.33 
Diluted $0.32  $(0.44) $(0.28) $0.32 
                
Weighted-average common shares outstanding:                
Basic  17,104,749   8,000,000   26,699,002   17,104,749 
Diluted  17,133,218   8,000,000   26,699,002   17,133,218 

The accompanying notes are an integral part of these consolidated financial statements.

 

4
 

BIOFRONTERA INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except number of shares)

(Unaudited)

 

Three Months Ended March 31, 20222023 and 20212022

  Shares  Amount  In Capital  Deficit  Total 
  Common Stock  Additional Paid-  Accumulated    
  Shares  Amount  In Capital  Deficit  Total 
Balance, December 31, 2022  26,699,002  $27  $103,370  $(79,519) $23,878 
Stock based compensation  -   -   351   -   351 
Net loss  -   -   -   (7,478)  (7,478)
Balance, March 31, 2023  26,699,002  $27  $103,721  $(86,997) $16,751 
                     
Balance, December 31, 2021  17,104,749  $17  $90,200  $(78,879) $11,338 
Stock based compensation  -   -   517   -   517 
Net income  -   -   -   5,561   5,561 
Net income (loss)  -   -   -   5,561   5,561 
Balance, March 31, 2022  17,104,749  $17  $90,717  $(73,318) $17,416 

 

  Shares  Amount  In Capital  Deficit  Total 
  Common Stock  Additional Paid-  Accumulated    
  Shares  Amount  In Capital  Deficit  Total 
                
Balance, January 1, 2021  8,000,000  $8  $46,986  $(41,166) $5,828 
Net loss  -   -   -   (3,534)  (3,534)
                     
Balance, March 31, 2021  8,000,000  $8  $46,986  $(44,700) $2,294 
                     
Balance, January 1, 2022  17,104,749  $17  $90,200  $(78,879) $11,338 
Stock-based compensation  -   -   517   -   517 
Net income  -   -   -   5,561   5,561 
Net income (loss)  -   -   -   5,561   5,561 
                     
Balance, March 31, 2022  17,104,749  $17  $90,717  $(73,318) $17,416 

The accompanying notes are an integral part of these consolidated financial statements.

5
 

 

BIOFRONTERA INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In Thousands)

(Unaudited)

 

 2022  2021  2023  2022 
 Three Months Ended March 31,  

Three Months Ended

March 31,

 
 2022  2021  2023  2022 
Cash Flows From Operating Activities:        
Cash flows from operating activities:        
                
Net income (loss) $5,561  $(3,534) $(7,478) $5,561 
                
Adjustments to reconcile net income (loss) to cash flows used in operations                
                
Depreciation  26   33   22   26 
Amortization of right-of-use assets  139   - 
Amortization of acquired intangible assets  105   105   105   105 
Change in fair value of investment in equity securities  2,941   - 
Change in fair value of contingent consideration  -   498   (200)  - 
Change in fair value of warrant liabilities  (8,711)  -   (1,028)  (8,711)
Stock-based compensation  517   -   351   517 
Provision for inventory obsolescence  -   35 
Provision for (recovery of) doubtful accounts  42   - 
Provision for doubtful accounts  14   42 
Non-cash interest expense  89   89   89   89 
                
Changes in operating assets and liabilities:                
Accounts receivable  (1,430)  1,509   (381)  (1,430)
Other receivables, related party  (38)  -   2,720   (38)
Prepaid expenses and other assets  3,614   (83)  (830)  3,614 
Inventories  (414)  (1,366)  499   (414)
Accounts payable and related party payables  (366)  (922)  (792)  (366)
Operating lease liabilities  (134)  - 
Accrued expenses and other liabilities  (1,107)  193   274   (1,107)
                
Cash flows used in operating activities  (2,112)  (3,443)  (3,689)  (2,112)
                
Cash flows from investing activities                
        
Purchases of property and equipment  (5)  -   (14)  (5)
                
Cash flows used in investing activities  (5)  -   (14)  (5)
                
Net decrease in cash and cash equivalents  (2,117)  (3,443)  (3,703)  (2,117)
Cash, cash equivalents and restricted cash, at the beginning of the period  24,742   8,277   17,408   24,742 
                
Cash, cash equivalents and restricted cash, at the end of the period $22,625  $4,834  $13,705  $22,625 
                
Supplemental disclosure of cash flow information                
Interest paid $4  $-  $-  $4 
Income tax paid, net $30  $1 
        
Supplemental non-cash investing and financing activities        
Deferred offering costs included in accrued expenses and other liabilities $-  $312 
Income taxes paid, net $22  $30 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

6
 

Biofrontera Inc.

Notes to Consolidated Financial Statements

(Unaudited)

1. Business Overview

We are

Biofrontera Inc (the “Company”). is a U.S.-based biopharmaceutical company specializing in the commercializationcommercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions in particular, diseases caused primarily by exposure to sunlight that results in sun damage to the skin. Our principalwith a focus on photodynamic therapy (“PDT”) and topical antibiotics. The Company’s licensed products focus onare used for the treatment of actinic keratoses, which are pre-cancerous skin lesions that can sometimes lead to skin cancer. We also market a licensed topical antibiotic for treatment ofas well as impetigo, a bacterial skin infection.

Biofrontera Inc. includes its wholly owned subsidiary Bio-FRI GmbH, a limited liability company organized under the laws of Germany. Our subsidiary, Bioi-FRI was formed on February 9, 2022, as a German presence to facilitate our relationship with the Ameluz Licensor.

Our principal licensed product is Ameluz®Ameluz®, which is a prescription drug approved for use in combination with our licensor’s FDA-approved medical device, the BF-RhodoLED® RhodoLED® lamp series, for photodynamic therapy (“PDT”)PDT (when used together, “Ameluz®PDT”) in. In the U.S.United States, the PDT treatment is used for the lesion-directed and field-directed treatment of actinic keratosiskeratoses (“AK”) of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz®Ameluz® for this indication in the U.S. under an exclusive license and supply agreement (“Ameluz LSA”), by between Biofrontera, Inc. and among us and Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH (collectively, the (“Ameluz Licensor”) originally dated as of October 1, 2016, and as subsequently amended on October 8, 2021. Refer to Note 16, Related Party Transactions, for further details.Licensors.

 

Our second prescription drug licensed product in our portfolio is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi® is known and it has been specifically approved by the FDA for the treatment of impetigo, due to staphylococcus aureus or streptococcus pyogenes. The approved indication is impetigo, a common skin infection.infection, due to Staphylococcus aureus or Streptococcus pyogenes. It is approved for use in the United States in adults and children 2 months and older. We are currently selling Xepi® for this indication in the U.S.United States. under an exclusive license and supply agreement, as amended (“Xepi LSA”) with Ferrer Internacional S.A. (“Ferrer”) that was acquiredassumed by Biofrontera Inc. on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc. Refer to Note 16, Related Party Transactions, for further details.(“Cutanea”).

 

Liquidity and Going Concern

The Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, and cash flows from equity financing transactions received in 2021.2022. As of March 31, 2022,2023, we had cash and cash equivalents of $22.413.5 million, compared to $24.517.2 million as of December 31, 2021.2022.

 

Since we commenced operations in 2015, we have generated significant losses. For the three months ended March 31, 20222023 and 2021,2022, we incurred lossesloss from operations of $3.15.5 million and $3.53.1 million, respectively. respectively. We incurred net cash outflows from operations of $2.13.7 million and $3.42.1 million, for the same periods, respectively. We had an accumulated deficit as of March 31, 20222023 of $73.387.0 million.

 

The Company’s short-term material cash requirements include working capital needs and satisfaction of contractual commitments including facility and auto leases (see Note 23,21. Commitments and Contingencies), Maruho start-up paymentscost financing repayments of $7.3million (see Note 3. Acquisition Contract Liabilities), and legal settlement expenses after reimbursement from Biofrontera AG a significant shareholder and our former parent company, of $5.62.5 million (see Note 13. Accrued Expenses and Other Current Liabilities).million. Long-term material cash requirements include potential milestone payments to Ferrer Internacional S.A, (see Note 23. Commitments and Contingencies) and contingent consideration payments to Maruho (seeconnected with Xepi sales (see Note 3. Acquisition Contract Liabilities)21. Commitments and Contingencies).

 

Additionally, we expect to continue to incur operating losses due to significant discretionary sales and marketing, medical affairs, and dermatology community outreach efforts as we seek to expand the commercialization of Ameluz® and Xepi®our licensed products in the United States. We also expect to incur additional expenses to add and improve operational, financial and information systems and personnel, including personnel to support our product commercialization efforts. In addition, we expect to incur significant costs to continue to comply with corporate governance, internal controlsregulatory reporting and similarother requirements applicable to us as a public company in the U.S. We expect capital expenditures to increase in 2022 to support the increase in our business needs including an ERP system.

 

These factors raise doubt about our ability to continue as a going concern, which we have determined are mitigated by the following plans. Based on current operating plans and financial forecasts, we expect that our revolving line of credit and expected proceeds from the sale of our investment in equity securities in addition to our current cash and cash equivalents will be sufficient to fund our operations for at least the next twelve months from the date of issuance of our financial statements. However, we expect to have to obtain either equity or additional debt financing to support our future long-term growth and to mitigate the risk of our operating costs significantly exceeding the amounts currently estimated. If our current operating plans or financial forecasts change, or we are unable to obtain additional financing, we may need to reduce the discretionary spend on promotional expenses, branding, marketing consulting and defer some hiring. While we expect to continue being flexible in our spending over the next twelve months, we do not consider there to be a need to significantly revise our operations currently.

 

7
 

2. Summary of Significant Accounting Policies

Basis for Preparation of the Financial Statements

 

The accompanying unaudited interim consolidated financial statements of the Company have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the Company’s opinion, the unaudited consolidated financial statements include all material adjustments, all of which are of a normal and recurring nature, necessary to present fairly the Company’s financial position as of March 31, 2022,2023, the Company’s operating results for the three months ended March 31, 20222023 and 2021,2022, and the Company’s cash flows for the three months ended March 31, 20222023 and 2021.2022. The accompanying financial information as of December 31, 20212022 is derived from audited financial statements. Interim results are not necessarily indicative of results for a full year. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2021,2022, filed with the SEC on April 11, 2022.March 13, 2023.

 

All amounts shown in these financial statements and accompanyingtables are in thousands and amounts in the notes are in thousands,millions, except percentages and per share and share amounts.

 

The Company’s significant accounting policies are discussed in Note 2—Summary of Significant Accounting Policies within the notes to financial statements for the year ended December 31, 2021,2022, included in the Company’s Annual Report on Form 10-K. There have been no significant changes to these policies during the three months ended March 31, 2022.2023.

 

Use of Estimates

 

The preparation of the financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions by management that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities, as reported on the balance sheet date, and the reported amounts of revenues and expenses arising during the reporting period. The main areas in which assumptions, estimates and the exercising of judgment are appropriate relate to, valuation allowances for receivables and inventory, valuation of contingent consideration and warrant liabilities, valuationrealization of intangible and other long-lived assets, product sales allowances and reserves, share-based payments and income taxes including deferred tax assets and liabilities. Estimates are based on historical experience and other assumptions that are considered appropriate in the circumstances. They are continuously reviewed but may vary from the actual values.

 

Recently IssuedAdopted Accounting Pronouncements

 

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which requires organizations that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. The new guidance requires that a lessee recognize assets and liabilities for leases with lease terms of more than twelve months and recognition, presentation and measurement in the financial statements will depend on the lease classification as a finance or operating lease. In addition, the new guidance will require disclosures to help investors and other financial statement users better understand the amount, timing and uncertainty of cash flows arising from leases. The JOBS ACT provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows us to delay the adoption of this new standard until it would otherwise apply to private companies. The new standard will be effective for us for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. The Company is currently evaluating the impact of adopting this guidance.

In JuneSeptember 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires entities to record expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity’s current estimate of credit losses expected to be incurred. The new standard will bewas effective for us on January 1, 2023. The Company is currently evaluating the impact of adopting this guidance.2023, and did not have a material effect on our consolidated financial statements.

 

3. Acquisition Contract Liabilities

On March 25, 2019, we entered into an agreement (as amended, the “Share Purchase Agreement”) with Maruho Co, Ltd. (“Maruho”) to acquire 100% of the shares of Cutanea Life Sciences, Inc. (“Cutanea”). As of the date of the acquisition, Maruho Co, Ltd. owned approximately 29.9% of Biofrontera AG through its fully owned subsidiary Maruho Deutschland GmbH. Biofrontera AG is our former parent, and currently a significant shareholder.

 

8
 

 

Pursuant to the Share Purchase Agreement, Maruho agreed to provide $7.3 million in start-up cost financing for Cutanea’s redesigned business activities (“start-up costs”). These start-up costs are to be paid back to Maruho by the end of 2023 in accordance with contractual obligations related to an earn-out arrangement. In addition, as part of the earn-out arrangement with Maruho, the product profit amount from the sale of Cutanea products as defined in the share purchase agreement will be shared equally between Maruho and Biofrontera until 2030 (“contingent consideration”).

 

In connection with this acquisition in 2019, we recorded the $7.3 million in start-up cost financing, a $1.7 million contract asset related to the benefit associated with the non-interest bearingnon-interest-bearing start-up cost financing and $6.5 million of contingent consideration related to the estimated profits from the sale of Cutanea products to be shared equally with Maruho.Maruho (see Note 21. Commitment and contingencies – Cutanea payments).

 

The contract asset related to the start-up cost financing is amortized on a straight-line basis using a 6.0% interest rate over the 57-month term of the financing arrangement, which ends on December 31, 2023. The contract asset is shown net of the related start-up cost financing within acquisition contract liabilities, net.

 

The contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate of approximately 6.0% over the applicable term. The contingent consideration is recorded within acquisition contract liabilities, net. The amount of contingent consideration that could be payable is not subject to a cap under the agreement. The Company re-measures contingent consideration and re-assesses the underlying assumptions and estimates at each reporting period utilizing a scenario-based method.

 

Acquisition contract liabilities, net consist of the following:

 Schedule of Acquisition Contract Liabilities

(in thousands) 

March 31,

2022

  December 31, 2021  

March 31, 2023

  December 31, 2022 
Short-term acquisition contract liabilities:                
Contingent consideration $-  $-  $2,200  $2,400 
Start-up cost financing  3,600   3,600   7,300   7,300 
Contract asset  (358)  (358)  (268)  (358)
Acquisition contract liabilities, net $3,242  $3,242  $7,032  $6,942 
                
Long-term acquisition contract liabilities:                
Contingent consideration $6,200  $6,200  $2,200  $2,400 
Start-up cost financing  3,700   3,700 
Contract asset  (268)  (358)
Acquisition contract liabilities, net $9,632  $9,542 
        
Total acquisition contract liabilities:                
Contingent consideration $6,200  $6,200  $2,200  $2,400 
Start-up cost financing  7,300   7,300   7,300   7,300 
Contract asset  (626)  (716)  (268)  (358)
Acquisition contract liabilities, net $12,874  $12,784 
Total acquisition contract liabilities, net $9,232  $9,342 

 

4. Fair Value Measurements

The following table presents information about the Company’s assets that are measured at fair value on a recurring basis at March 31, 20222023 and December 31, 20212022 and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:

Schedule of Fair Value Hierarchy Valuation Inputs

(in thousands) 

 

Level

 March 31,
2022
  

December 31,

2021

  Level  

March 31, 2023

  December 31, 2022 
     
Assets:            
Investment in equity securities  1  $7,596  $10,548 
Liabilities:                    
Contingent Consideration 3 $6,200  $6,200   3  $2,200  $2,400 
Warrant liability- Purchase warrant 3 $4,143  $12,854 
Warrant liability – 2022 Purchase Warrants  3  $786  $1,129 
Warrant liability - 2022 Inducement Warrants  3  $1,029  $1,714 
Warrant liability  3  $1,029  $1,714 

 

9
 

Investment in equity securities

 

As of March 31, 2023, the Company had an investment in shares of Biofrontera AG. The fair value of this investment was determined with Level 1 inputs through references to quoted market prices.

Contingent Consideration

Contingent consideration, which relates to the estimated profits from the sale of Cutanea products to be shared equally with Maruho, is reflected at fair value within acquisition contract liabilities, net on the consolidated balance sheets. The fair value is based on significant inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The valuation of the contingent consideration utilizes a scenario-based method under which a set of payoffs are calculated using the term of the earnout, projections, and an appropriate metric risk premium. These payoffs are then discounted back from the payment date to the valuation date using a payment discount rate. Finally, the discounted payments are summed together to arrive at the value of the contingent consideration. The scenario-based method incorporates the following key assumptions: (i) the forecasted product profit amounts, (ii) the remaining contractual term, (iii) a metric risk premium, and (iv) a payment discount rate. The Company re-measures contingent consideration and re-assesses the underlying assumptions and estimates at each reporting period.

 

The following table provides a roll forward of the fair value of the contingent consideration:

 Schedule of Fair Value of Contingent Consideration

(in thousands)      
Balance at December 31, 2020 $7,602 
Change in fair value of contingent consideration  498 
Balance at March 31, 2021 $8,100 
    
Balance at December 31, 2021 $6,200  $6,200 
Change in fair value of contingent consideration  -   - 
Balance at March 31, 2022 $6,200  $6,200 
    
Balance at December 31, 2022 $2,400 
Change in fair value of contingent consideration  (200)
Balance at March 31, 2023 $2,200 

 

Warrant LiabilityLiabilities

 

WarrantsThe warrant liabilities, comprised of warrants to purchase one share of common stock issued in conjunction with thea private placement on May 16, 2022, expiring five and one-half years after the issue date and with an exercise price of $2.77 per share (the “Purchase Warrants”) and warrants to an institutional shareholder which closedpurchase one share of common stock issued on July 26, 2022, expiring on December 2, 20211, 2026 with an exercise price of $1.66 per share (the “Inducement Warrants”), were accounted for as liabilities in accordance with ASC 815-40. Pre-funded common stock purchase warrants to purchase up to 1,507,143 shares of our common stock at a nominal exercise price (the “Pre-funded Warrants”) were exercised in 2021815-40 and the common stock purchase warrants to purchase up to 2,857,143 shares of our common stock at an exercise price of $5.25 per share (the Purchase Warrants”) are presented within warrant liabilityliabilities in the accompanying consolidated balance sheets. The warrant liability isliabilities are measured at fair value at inception and on a recurring basis, with changes in fair value presented within the consolidated statements of operations.

 

The Company utilizes a Black-Scholes option pricing model to estimate the fair value of the Purchase Warrants and Inducement Warrants which is considered a Level 3 fair value measurement. Certain inputs utilized in our Black-Scholes pricing model may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of fair value may cause a significant change to the fair value of our warrant liabilityliabilities which could also result in material non-cash gain or loss being reported in our consolidated statements of operations.

The fair value at March 31, 2023 was estimated using a Black-Scholes pricing model based on the following assumptions:

Schedule of Fair value Warrant by Using Black-Scholes Pricing Model Assumptions

  Purchase  Inducement 
Stock price $0.61  $0.61 
Expiration term (in years)  4.63   3.67 
Volatility  85.0%  85.0%
Risk-free Rate  3.61%  3.71%
Dividend yield  0.0%  0.0%

 

The following table presents the changes in the warrant liabilityliabilities measured at fair value (in thousands):

Schedule of Changes in Fair Value Warrant Liabilities

(in thousands)   
Fair value at December 31, 2021 $12,854 
Change in fair value of warrant liability  (8,711)
Fair value at March 31, 2022 $4,143 
  

2023

  

2022

 
  Three Months Ended March 31, 
  

2023

  

2022

 
Fair value at beginning of period $2,843  $12,854 
Change in fair value of warrant liability  (1,028)  (8,711)
Fair value at end of period $1,815  $4,143 

 

10
 

 

5.Revenue

We generate revenue primarily through the sales of our licensed products Ameluz®, BF-RhodoLED® lamps and Xepi®. Revenue from the sales of our BF-RhodoLED® lamp and Xepi® are relatively insignificant compared with the revenues generated through our sales of Ameluz®.

 

We generated $9.6 million of Ameluz® revenue, $0.1 million Xepi® revenue, and $0.1 million of BF-RhodoLED® lamps revenue during the three months ended March 31, 2022. We generated $4.5 million of Ameluz® revenue, minimal Xepi® revenue, and $0.2 million of BF-RhodoLED® lamps revenue during the three months ended March 31, 2021.

Related party revenue relates to an agreement with Biofrontera Bioscience GmbH (“Bioscience”) for BF-RhodoLED® leasing and installation service. Refer to Note 16,15, Related Party Transactions.

 

An analysis of the changes in product revenue allowances and reserves is summarized as follows:

 Schedule of Revenue Allowance and Accrual Activities

(in thousands): Returns Co-pay assistance  program Prompt pay discounts Government and payor rebates Total  Returns  Co-pay assistance program  Prompt pay discounts  Government and payor rebates  Total 
Balance at December 31, 2020 $217  $52  $15  $43  $327 
Provision related to current period sales  1   87   3   23   114 
Credit or payments made during the period  (120)  (88)  (2)  (25)  (235)
Balance at March 31, 2021 $98  $51  $16  $41  $206 
                    
Balance at December 31, 2021 $43  $101  $48  $54  $246  $43  $101  $48  $54  $246 
Provision related to current period sales  3   165   5   45   218   3   165   5   45   218 
Credit or payments made during the period  (5)  (150)  (17)  (52)  (224)  (5)  (150)  (17)  (52)  (224)
Balance at March 31, 2022 $41  $116  $36  $47  $240  $41  $116  $36  $47  $240 
                    
Balance at December 31, 2022 $48  $9  $5  $20  $82 
Beginning Balance $48  $9  $5  $20  $82 
Provision related to current period sales  1   62   3   33   99 
Credit or payments made during the period  -   (71)  (2)  (39)  (112)
Balance at March 31, 2023 $49   -   6   14   69 
Ending Balance $49   -   6   14   69 

 

6. Accounts Receivable, net

 

Accounts receivablereceivables are mainly attributable to the sale of Ameluz®, the BF-RhodoLED® and Xepi®. It is expected that all trade receivables will be settled within twelve months of the balance sheet date. Trade accounts receivable are stated at their net realizable value. The allowance for credit losses reflects our best estimate of expected credit losses of the receivables determined on the basis of historical experience and current information. In developing the estimate for expected credit losses, trade accounts receivables are segmented into pools of assets depending primarily on delinquency status, and fixed reserve percentages are established for each pool of trade accounts receivables.

 

The allowance for doubtful accountscredit losses was $60,0000.1 and $18,000million as of March 31, 20222023 and December 31, 2021, respectively.2022.

 

7. Other Receivables, Related Party

 

TheAs of March 31, 2023 the Company has recorded a receivable of $11.33.8 million due from the Biofrontera Group of which $3.7 million is due from Biofrontera AG for its 50%50% share of the balance of a legal settlement (see Note 21. Commitments and Contingencies – Legal proceedings) for which both parties are jointly and severally liable for the total settlement amount of $22.5 million.liable. The Company has a contractual right to repayment of its share of the settlement paymentpayments, plus interest and other miscellaneous settlement costs, from Biofrontera AG under the Settlement Allocation Agreement (“Allocation Agreement”) entered into on December 9, 2021 and as amended on March 31, 2022, which providedprovides that the settlement payments would first be made by the Company and then reimbursed by Biofrontera AG for its share. Of the total receivable $8.4The million is short-term and $2.8 million is long-term. As of May 11, Biofrontera AG has not paid the first reimbursement amount to the Company. We determined that the potential of Biofrontera AG to default on its obligation was less than probable. This is supported by the March 31, 2022 Amended Settlement Allocation Agreement, between the Company and Biofrontera AG. The Amended Allocation Agreementas amended, provides certain remedies to the Company, if Biofrontera AG fails to make timely reimbursements, which the Company may implement in its sole discretion, including the ability to charge interest at a rate of 6.0% per annum for each day that any reimbursement is past due and the ability to offset any overdue reimbursement amounts against payments owed to Biofrontera AG by the Company (including amounts owed under the Company’s license and supply agreement for Ameluz®). As such, no reserve for the receivable has been recorded as of March 31, 20222023 or December 31, 2021.2022.

11
 

 

The remaining $0.2 million of other receivables, related party pertains to service agreements and chargebacks. See Note 16- Related Party Transactions.

8.Inventories

Inventories are comprised of Ameluz®, Xepi® and the BF-RhodoLED® finished products.

 

In assessing the consumption of inventories, the sequence of consumption is assumed to be based on the first-in-first-out (FIFO) method. There was no provision for obsolescence recorded for the three months ended March 31, 2023 and 2022. We recorded a provision of $35,000 for Xepi® inventory obsolescence, for the three months ended March 31, 2021.

9.Prepaid Expenses and Other Current Assets

 

Prepaid expenses and other current assets consist of the following:

Schedule of Prepaid Expenses and Other Current Assets

(in thousands) 

March 31,

2022

  

December 31,

2021

  

March 31, 2023

  December 31, 2022 
     
Receivable for common stock warrants proceeds $-  $3,258 
Prepaid expenses  723  $824  $593  $240 
Prepaid insurance  512   15 
Prepaid licenses  423   317 
Security deposits  128   149   -   85 
Other  522   756   58   153 
Total $1,373  $4,987  $1,586  $810 

 

10. Property and Equipment, Net

Property and equipment, net consists of the following:

Schedule of Property and Equipment

(in thousands) 

March 31,

2022

  

December 31,

2021

  

March 31, 2023

  December 31, 2022 
Computer equipment $87  $85  $94  $89 
Computer software  27   27   27   27 
Furniture & fixtures  81   81   81   81 
Leasehold improvement  368   368   368   368 
Machinery & equipment  114   112   155   145 
Property and equipment, gross  677   673   725   710 
Less: Accumulated depreciation  (432)  (406)  (528)  (506)
Property and equipment, net $245  $267  $197  $204 

 

Depreciation expense was $26,000 and $33,000, for the three months ended March 31, 2023 and 2022 was negligible and 2021, respectively, which was included in selling, general and administrative expense onin the consolidated statements of operations.

 

11. Intangible Asset, Net

Intangible asset, net consists of the following:

Schedule of Intangible Asset Net

(in thousands) 

March 31,

2022

  

December 31,

2021

  

March 31, 2023

  December 31, 2022 
Xepi® license $4,600  $4,600  $4,600  $4,600 
Less: Accumulated amortization  (1,255)  (1,150)  (1,673)  (1,568)
Intangible asset, net $3,345  $3,450  $2,927  $3,032 

 

12
 

 

The Xepi® license intangible asset was recorded at acquisition-date fair value of $4.6million and is amortized on a straight-line basis over the useful life of 11years. Amortization expense for the three months ended March 31, 20222023 and 20212022 was $0.1million.

 

We review the Xepi® license intangible asset for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable.

The Company did not recognize any impairment charges during the three months ended March 31, 20222023 or March 31, 2021.2022.

 

12. Statement of Cash Flows Reconciliation

The following table provides a reconciliation of cash, cash equivalents, and restricted cash that sum to the total shown in the consolidated statements of cash flows:

Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash

(in thousands) 

March 31,

2022

  

December 31,

2021

  

March 31, 2023

  December 31, 2022 
Cash and cash equivalents $22,428  $24,545  $13,505  $17,208 
Short-term restricted cash  47   47 
Long-term restricted cash  150   150   200   200 
Total cash, cash equivalent, and restricted cash shown on the statements of cash flows $22,625  $24,742 
Total cash, cash equivalent, and restricted cash shown on the consolidated statements of cash flows $13,705  $17,408 

13. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following:

Schedule of Accrued Expenses and Other Current Liabilities

(in thousands) 

March 31,

2022

  

December 31,

2021

  

March 31, 2023

  December 31, 2022 
Legal settlement (See note 23) $5,625  $5,625 
Legal settlement (See note 21) $

6,094

  $6,207 
Employee compensation and benefits  1,440   2,384   

3,155

   2,850 
Professional fees  514   570   

1,303

   1,353 
Product revenue allowances and reserves  240   246   

69

   82 
Other  727   829   

514

   372 
Total $8,546  $9,654  $

11,135

  $10,864 

14. Other Long-Term Liabilities

Other long-term liabilities consist of the following:

Schedule of Other Long Term Liabilities

(in thousands) 

March 31,

2022

  

December 31,

2021

 
Legal settlement – noncurrent (See note 23) $5,625  $5,625 
Other  27   24 
Total $5,652  $5,649 

15.Income Taxes

 

As a result of the net losses, we have incurred in each fiscal year since inception, we have recorded no provision for federal income taxes for the three-month periods ended March 31, 20222023 and 2021.2022. Income tax expense incurred for the three months ended March 31, 20222023 and 20212022 relates to state income taxes. At March 31, 20222023 and December 31, 2021,2022, the Company had no unrecognized tax benefits.

 

The Company continues to be in a cumulative loss position and as such, is maintaining a full valuation allowance.

 

Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as income tax expense in the accompanying consolidated statements of operations. As of March 31, 2022,2023, and December 31, 2021,2022, the Company has no accrued interest related to uncertain tax positions. Since the Company is in a loss carryforward position, it is generally subject to examination by the U.S. federal, state, and local income tax authorities for all tax years in which a loss carryforward is available.

 

13
 

 

16.15. Related Party Transactions

License and Supply Agreement

On October 1, 2016, the Company executed an exclusive license and supply agreement with Biofrontera Pharma GmbH (“Pharma”), which was amended in July 2019 to increase the Ameluz® transfer price per unit from 35.0% to 50.0% of the anticipated net selling price per unit as defined in the agreement. It was further amended on October 8, 2021 so that the price we pay per unit will be based upon our sales history, although the minimum number of units to purchase per year remains unchanged. As a result of this amendment, the purchase price we pay Biofrontera Pharma for Ameluz® will range from 30% to 50% of the anticipated net price per unit based on our level of annual revenue. Refer to Item I. Business - Commercial Partners and Agreements in our Annual Report on Form 10-K for the year ended December 31, 2021 for further details. Under the agreement, the Company obtained an exclusive, non-transferable license to use the Pharma’s technology to market and sell the licensed products, Ameluz® and BF-RhodoLED® and must purchase the licensed products exclusively from Pharma. There was no consideration paid for the transfer of the license.

 

Purchases of the licensed products during the three months ended March 31, 20222023 and 20212022 were $5.24.6 million and $3.05.2 million, respectively and recorded in inventories in the consolidated balance sheets, and, when sold, in cost of revenues, related party in the consolidated statements of operations. Amounts due and payable to Pharma as of March 31, 20222023 and December 31, 20212022 were $0.30.9 million and $0.31.3 million, respectively, which were recorded in accounts payable, related parties in the consolidated balance sheets.

 

Service Agreements

In December 2021, we entered into an Amended and Restated Master Contract Services Agreement, or Services Agreement,“Services Agreement”, which provides for the execution of statements of work that will replace the applicable provisions of our previous intercompany services agreement dated January 1, 2016, or 2016 Services Agreement, by and among us, Biofrontera AG, Biofrontera Pharma and Biofrontera Bioscience, enabling us to continue to use the IT resources of Biofrontera AG and its wholly owned subsidiaries (the “Biofrontera Group”) as well as providing access to the Biofrontera Group’s resources with respect to quality management, regulatory affairs and medical affairs. If we deem that the Biofrontera Group should continue to provide these services, we will execute a statement of work under the Services Agreement with respect to such services. We currently have statements of work in place regarding IT, regulatory affairs, medical affairs, pharmacovigilance, and investor relations services,pharmacovigilance, and are continuously assessing the other services historically provided to us by Biofrontera AG to determine 1) if they will be needed, and 2) whether they can or should be obtained from other third-party providers. As of March 31, 2023, we have migrated away from Biofrontera AG to third party providers for most of our significant IT services . Expenses related to the service agreement were $0.1 millionnegligible for the three months ended March 31, 2023 and $0.2 0.1million for the three months ended March 31, 2022, and 2021, respectively which were recorded in selling, general and administrative, related party. There were no amountsAmounts due to Biofrontera AG related to the service agreement as of March 31, 2022. Amounts due to Biofrontera AG related to the service agreement2023 and December 31, 2022 were $0.2million as of December 31, 2021and $0.2 million, respectively, which were recorded in accounts payable,offset against other receivables, related partiesparty in the consolidated balance sheets.  sheet.

 

Clinical Lamp Lease Agreement

On August 1, 2018, the Company executed a clinical lamp lease agreement with Biofrontera Bioscience GmbH (“Bioscience”) to provide lamps and associated services.

 

Total revenue related to the clinical lamp lease agreement was approximately $15,000 and $13,000minimal for the three months ended March 31, 20222023 and 2021,2022, respectively and was recorded as revenues, related party. Amounts due from Bioscience for clinical lamp and other reimbursements were approximately $99,0000.2 million and $92,0000.1 as of March 31, 20222023 and December 31, 2021,2022, respectively, which were recorded as other receivables, related party in the consolidated balance sheets.

14
 

Reimbursements from Maruho Related to Cutanea Acquisition

Pursuant to the Cutanea acquisition share purchase agreement, we received start-up cost financing and reimbursements for certain costs. These restructuring costs Maruho agreed to pay are referred to as “SPA costs” under the arrangement and are to be accounted for as other income. Refer to Note 3, Acquisition Contract Liabilities.

There were 0 amounts reimbursed relating to SPA costs for the three months ended March 31, 2022. For the three months ended March 31, 2021, the amounts reimbursed relating to SPA costs were $0.1 million and were recorded as other income in the statements of operations as the related expenses were incurred. As of March 31, 2022 and December 31, 2021 amounts due from Maruho, primarily relating to SPA cost reimbursements, were $56,000 for each of the periods and were recorded in other receivables, related parties in the balance sheets.

 

Others

The Company receives expense reimbursement from Biofrontera AG and Biofrontera Bioscience on a quarterly basis for costs incurred on behalf of these entities. Total expense reimbursements were $0.1 million for the three months ended March 31, 2022 and 2021, which were netted against expenses incurred within selling, general and administrative expenses.

 

The Company has recorded a receivable of $11.33.7 million and $6.4 million as of March 31, 2023 and December 31, 2022, respectively, due from Biofrontera AG for its 50%50% share of the balance of a legal settlement for which both parties are jointly and severally liable for the total settlement amount of $22.5 million. The Company has a contractual rightliable. Refer to repayment of its share of the settlement payment from Biofrontera AG under the Settlement Allocation Agreement entered into on December 9, 2021 and amended on March 31, 2022, which provided that the settlement payments would first be made by the Company and then reimbursed by Biofrontera AG for its share. The amended agreement provides certain remedies to the Company, if Biofrontera AG fails to make timely reimbursements, which the Company may implement in its sole discretion, including the ability to charge interest at a rate ofNote 7, Other Receivables, Related Party. There was 6.0%no per annum for each day that any reimbursement is past due and the ability to offset any overdue reimbursement amounts against payments owed to Biofrontera AG by the Company (including amounts owed under the Company’s license and supply agreement for Ameluz®). The Company has accrued $56,000 of interest income as of March 31, 2022. Of the total receivable of $11.3 million, $8.5 million is short-term and $2.8 million is a long-term receivable.

17. Restructuring costs

We restructured the business of Cutanea and incurred restructuring costs which were subsequently reimbursed by Maruho. Restructuring costs primarily relate to the winding down of Cutanea’s operations. There were 0 restructuring costsrecognized for the three months ended March 31, 2022. For2023 and $0.1 million of interest income for the three months ended March 31, 2021, restructuring costs were incurred2022, in connection with this receivable.

As of March 31, 2023, our investment in equity securities is valued at $7.6 million and consists of 6,466,946 common shares of Biofrontera AG, a significant shareholder of the amount of $0.3 million.Company.

 

18.16. Stockholders’ Equity

Under the Company’s amended and restated certificate of incorporation, dated December 21, 2020, the Company is authorized to issue 300,000,000 shares of common stock, par value $0.001 per share and 20,000,000 shares of preferred stock, par value $0.001.001 per share.

 

The holders of common stock are entitled to one vote for each share held. Common stockholders are not entitled to receive dividends, unless declared by the Board of Directors. The Company has not declared dividends since inception. In the event of liquidation of the Company, dissolution or winding up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities. The common stock has no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions applicable to the common stock. The outstanding shares of common stock are fully paid and non-assessable.

 

15
 

19.17. Equity Incentive Plans and Share-Based Payments

2021 Omnibus Incentive Plan

 

In 2021, our Board of Directors adopted and our shareholders approved, the 2021 Omnibus Incentive Plan (“2021 Plan). Under the original 2021 Plan, 2,750,000shares are reserved and authorized for awards and the maximum contractual term is 10 yearsfor stock options issued under the 2021 Plan. On December 12, 2022, the 2021 Plan was amended by our stockholders and the number of shares authorized for awards under the 2021 Plan was increased by 2,589,800 to 5,339,800. As of March 31, 2023, there were 2,946,988 shares available for future awards under the amended 2021 Plan.

Non-qualified stock options

DuringWe maintain the quarter ended March 31, 2022,2021 Plan for the Company granted non-qualifiedbenefit of our officers, directors and employees. Employee stock options to certain employees to purchase 28,378 shares of common stockgranted under the 2021 Omnibus Incentive Plan. ThePlan generally vest in equal annual installments over three years and are exercisable for a period of up to ten years from the grant date. Non-employee director options were granted to employeesvest in equal monthly installments following the date of grant and will be fully vested on March 2, 2022 with an exercise pricethe one-year anniversary of $2.96 and a contractual termthe date of ten years. Thesegrant. All stock options hadare exercisable at a grant-date fairprice as set by the Company at the time of the grant but shall not be less than the market value of $44,000 and vest annually over a three-year period, subject to the recipient’s continued service withcommon shares underlying the Company throughoption on the applicable vesting dates.grant date.

 

The Company recognizes the grant-date fair value of share-based awards granted as compensation expense on a straight-line basis over the requisite service period. The fair value of stock options is estimated at the time of grant using the Black-Scholes option pricing model, which requires the use of inputs and assumptions such as the fair value of the underlying stock, exercise price of the option, expected term, risk-free interest rate, expected volatility and dividend yield. The Company elects to account for forfeitures as they occur.

 

The fair value of each option grant was estimated on the grant date of March 2, 2022,the grant using the Black-ScholesBSM option pricing model with the following assumptions: fair value

Schedule of the underlying unit of $2.96Stock Options Assumptions, expected volatility of 55.0%, risk free rate of 1.79%, term of 6 years and a dividend yield of 0.

  Three Months Ended March 31, 
  2023  2022 
Expected volatility  70%  55%
Expected term (in years)  6.0   6.0 
Risk-free interest rate  3.5% - 3.7%  1.79%
Expected dividend yield  0.0%  0.0%

 

Share-based compensation expense of approximately $0.3 million and $0.1 million was recorded in selling, general and administrative expenses on the accompanying consolidated statement of operations for the three months ended March 31, 2022. There was 0 stock based compensation for the three months ended2023 and March 31, 2021.2022, respectively.

 

Options outstanding and exercisable under the employee share option plan as of March 31, 20222023 and a summary of option activity during the three months then ended is presented below.

 Schedule of Stock UnitOption Activity

 Shares  Weighted Average Exercise Price  Weighted Average Remaining Contractual Term  

Aggregate Intrinsic Value (1)

(in 000’s)

  Shares  

Weighted

Average

Exercise

Price

 

Weighted

Average

Remaining

Contractual

Term

 

Aggregate

Intrinsic

Value (1)

 
Outstanding at December 31, 2021  613,614  $4.77   9.94   1,687 
Outstanding at December 31, 2022  1,737,344  $3.11           
Granted  28,378  $2.96           200,692  $0.99         
Exercised  -  $-           -  $-         
Canceled or forfeited  (38,096) $4.77           (58,804) $2.42         
Outstanding at March 31, 2022  603,896  $4.68   9.53  $10 
Exercisable at March 31, 2022  -  $-   -  $- 
Outstanding at March 31, 2023  1,879,232  $2.90   9.09  $- 
Exercisable at March 31, 2023  251,496  $4.07   8.73  $- 

 

(1)The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of the common stock for the options that were in the money at March 31, 2022.2023.

 

As of March 31, 2022,2023, there was $1.32.0 million of unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a weighted-average period of approximately 2.702.1 years.

 

Share-Based Compensation (RSUs)

 

There were 0 RSU’s granted duringRestricted Stock Units (“RSUs”) will vest annually over two years, subject to the three months ended March 31, 2022. During the year ended December 31, 2021,recipient’s continued service with the Company granted to certain members of management 170,068 restricted stock units, or RSUs.through the applicable vesting dates. The fair value of each RSU is estimated based on the closing market price of the Company’s common stock on the grant date.

 

The RSUs had a grant-date fair value of $0.8 million and will be fully vested on June 9, 2022, six months after the grant date, subject to the recipient’s continued service with the Company through the applicable vesting dates. Share-based compensation expense of $0.1 million and $0.4 million for the RSUs was recorded in selling, general and administrative expenses in the accompanying statementconsolidated statements of operations for the three months ended March 31, 2022. There was 0 share-based compensation for the three months ended2023 and March 31, 2021.2022, respectively.

 

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As of March 31, 2022,2023, there was $0.30.5 million of unrecognized compensation cost related to unvested RSUs, which is expected to be recognized over a weighted-average period of approximately 0.191.1 years.

 

Schedule of Restricted Stock Units

  Shares  Weighted Average Remaining Contractual Term  

Aggregate Intrinsic

Value

  Weighted Average Grant Date Fair Value 
Outstanding at December 31, 2022  343,512      $  $2.61 
Awarded  -      $  $- 
Vested  -      $  $- 
Canceled or forfeited  -      $  $- 
Outstanding at March 31, 2023  343,512   0.63  $210  $2.61 
Expected to vest at March 31, 2023  343,512   0.63  $210  $2.61 

20.18. Interest Expense, net

 

Interest expense, net consists of the following:

Schedule of Interest Expense

(in thousands) 2022  2021 
      
 Three Months Ended March 31,  Three Months Ended March 31, 
(in thousands) 2022  2021  2023  2022 
Interest expense  (4)  -   (2)  (4)
Contract asset interest expense  (89)  (89)  (89)  (89)
Interest income  60   5   56   60 
Interest expense, net $(33) $(84) $(35) $(33)

 

Contract asset interest expense relates to the $1.7 million contract asset in connection with the $7.3 million start-up cost financing received from Maruho under the Cutanea acquisition share purchase agreement. The contract asset is amortized on a straight-line basis using a 6%6% interest rate over the financing arrangement contract term, which ends on December 31, 2023.

 

21.19. Other Income (expense), net

 

Other income net consists of the following:

Schedule of Other Income, Net

(in thousands) 2022  2021 
  Three Months Ended March 31, 
(in thousands) 2022  2021 
Reimbursed SPA costs $-  $98 
Other, net  23   (19)
Other income, net $23  $79 

Other,(expense), net primarily includes (i) gain (loss) on sale of leased assets and (ii) gain (loss) on foreign currency transactions and gain on termination of operating leases.transactions.

 

22.20. Net LossEarnings (Loss) per Share

Basic net earnings per common share are calculated by dividing net income by the weighted average number of common shares outstanding during the period. Diluted net earnings per common share are calculated by dividing net income by the diluted weighted average number of common shares outstanding during the period. The diluted shares include the dilutive effect of stock-based awards based on the treasury stock method. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive.

 

BasicThe following table sets forth the computation of the Company’s basic and diluted net income (loss)loss per share attributable to common stockholders is calculated as follows:stockholders. (in thousands, except share and per share data):

Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders

 2022 2021  2023  2022 
 Three Months Ended March 31,  Three Months Ended March 31, 

(only dollars are in thousands)

 2022 2021 
 2023  2022 
Net income (loss) $5,561  $(3,534) $(7,478) $5,561 
                
Shares                
Basic weighted average common shares outstanding  17,104,749   8,000,000   26,699,002   17,104,749 
Add: Effect of dilutive securities                
Stock options and restricted stock units  28,469   -   -   28,469 
Diluted weighted average common shares outstanding  17,133,218   8,000,000   26,699,002   17,133,218 
                
Net earnings (loss) per share:                
Basic $0.33  $(0.44) $(0.28) $0.33 
Diluted $0.32  $(0.44) $(0.28) $0.32 

 

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The following table sets forth the potential common sharessecurities that were not includedanti-dilutive for diluted EPS for the periods presented but which could potentially dilute EPS in the diluted per share calculations for the three months ended March 31, 2022 because the exercise price was greater than their average market value and they would be anti-dilutive:future:

Schedule of Anti-dilutive Securities Excluded From Computation of Earnings Per Share

March 31, 2022  2021 
Common stock warrants  4,349,537   4,349,537 
Common stock options  575,518   613,614 
Restricted Stock Units  -   170,068 
Total anti-dilutive securities  -   170,068 
March 31, 2023  2022 
Common stock warrants  9,197,109   4,349,537 
Common stock options and RSUs  2,198,745   575,518 
Unit Purchase Options  403,628   403,628 
Anti-dilutive securities excluded from computation of earnings per share  403,628   403,628 

Common stock warrants include Purchase Warrants, Inducement Warrants and warrants issued in the Initial Public Offering.

23.21. Commitments and Contingencies

 

Facility Leases

 

The Company leases its corporate headquarters under an operating lease that expires in NovemberAugust 2025. The Company has the option to extend the term of the lease for one five (5) year period upon written notice to the landlord. The extension period has not been included in the determination of the ROU asset or the lease liability as the Company concluded that it is not reasonably certain that it would exercise this option. The Company provided the landlord with a security deposit in the amount of $0.1 million, which was recorded as other assets in the consolidated balance sheets.

 

Rent expenseThe Company has also entered into a master lease agreement for its vehicles. After an initial non-cancelable twelve-month period, each vehicle is recordedleased on a straight-line basismonth to month basis. Based on historical retention experience of approximately three years, the vehicles have expiration dates ranging from February 2023 through the endSeptember 2025.

The components of the lease term. The Company incurred rent expense in the amount of $0.1 million and $0.2 million for the three months ended March 31, 20222023 were as follows (in thousands except lease term and 2021, which was included in selling, general,discount rate):

Schedule of Components of Lease Expense and administrative expenses.Other Information

Lease expense Operating Leases 
Amortization of ROU assets (operating lease cost) $139 
Interest on lease liabilities  20 
Total lease expense $159 

Other Information   
Operational cash flow used for operating leases $154 
ROU assets obtained in exchange for lease liabilities  - 
Weighted -average remaining lease term (in years)  2.33 
Weighted -average discount rate  6.31%

 

Auto Leases

The Company alsoFuture lease payments under non-cancelable leases autos for its field sales force with a lease payment term of 40 months. The Company incurred auto lease expense of $0.1 million for the three months ended March 31, 2022 and 2021.

The minimum aggregate payments of all future lease commitments as of March 31, 2022, are2023 were as follows:follows (in thousands):

(in thousands)

Schedule of Future Commitments and Sublease Income

Years ending December 31, Future lease commitments  Future lease commitments 
Remainder of 2022 $665 
2023  522  $409 
2024  473   541 
2025  352   349 
Thereafter  -              - 
Total $2,012 
Total future minimum lease payments  1,299 
Less imputed interest  (90)
Total lease liability $1,209 

Schedule of Operating Lease Liability

Reported as:   
Operating lease liability, current $484 
Operating lease liability, non-current  725 
Total $1,209 

Cutanea earnout payments

 

We are obligatedhave a contract in which we agreed to repay to Maruho $3.6 million on December 31, 2022 and $3.7 million on December 31, 2023 in start-up cost financing paid to us in connection with the Cutanea acquisition.

 

We have filed for arbitration against Maruho with the International Chamber of Commerce (“ICC”) regarding issues with Maruho’s contract manufacturer that were not disclosed at the time of the Agreement and therefore are withholding the repayment of the start-up cost financing until a decision is reached through the arbitration process. The arbitration notes that Maruho breached the agreement with Cutanea due to the undisclosed manufacturing issues and seeks damages as well as a declaration that we are not obligated to repay Maruho.  

We are also obligated to share product profits with Maruho equally from January 1, 2020 through October 30, 2030. Refer to Note 3, Acquisition Contract Liabilities.

 

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Milestone payments with Ferrer Internacional S.A.

 

Under the Xepi LSA, we are obligated to make payments to Ferrer upon the occurrence of certain milestones. Specifically, we must pay Ferrer i) $2,000,000 upon the first occasion when annual net sales of Xepi®Xepi® under the Xepi LSA exceed $25,000,000, and ii) $4,000,000 upon the first occasion annual net sales of Xepi® Xepi® under the Xepi LSA exceed $50,000,000. No payments werehave been made for the three months ended March 31, 2022 or 2021 related to Xepi®Xepi® milestones.

Contingent liability related to shares of Biofrontera AG acquired from Maruho through subscription rights

Dependent on the outcome of the arbitration process between Biofrontera AG and Maruho, the Company may be liable for an additional payout of $0.9 million in relation to the shares of Biofrontera AG acquired from Maruho through a subscription rights agreement. In accordance with ASC 450-20-50-3, Contingencies, we have not accrued any liability associated with the subscription rights purchase, as the liability is not considered probable.

 

Legal proceedings

 

At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of FASB ASC Topic 450, Contingencies. The Company expenses as incurred the legal costs related to such legal proceedings.We are not presently a party to any pending legal proceedings.

 

On November 29, 2021, the Company entered into a settlement and release agreement with respect to a lawsuit filed March 23, 2018 in the United States District Court for the District of Massachusetts in which we were alleged to have infringed on certain patents and misappropriated certain trade secrets. In the settlement, the Company and Biofrontera AG together agreed to make an aggregate payment of $22.5 million and engage a forensic expert to destroy data at issue in the litigation to settle the claims in the litigation. The Company will be responsible for $11.25 million of the aggregate settlement amount, plus interest accrued at a rate equal to the weekly average one-year constant maturity Treasury yield and agreed to pay in three annual installments. The first installment of $11.3 million (of which $5.6 million was Biofrontera AG’s portion) was paid in December 2021 by the Company.

 

While Biofrontera AG has agreed to pay a portionfifty percent of the settlement both partiescosts, we remain jointly and severally liable to DUSA for the full cash settlement amount, meaning that in the event Biofrontera AG does not pay all or a portion of the amount it owes under the agreement, the claimantAgreement, DUSA could compel the Companyus to pay Biofrontera AG’s share. If either the Companywe or Biofrontera AG violates the terms of the settlement agreement, this could nullify the settlement and the Companywe or Biofrontera AG may lose the benefits of the settlement and be liable for a greater amount. If we become liable for more than our agreed share of the aggregate settlement amount, either of these events could have a material adverse effect on our business, prospects, financial condition and/or results of operations. As of March 31, 2021,2023, we have recordedreflected a legal settlement liability in the amount of $11.3 6.1million for the remaining payments due under the settlement, including the estimated remaining cost of the forensic expert and a related receivable from related party of $11.3 3.7million for the remaining legal settlement costs to be reimbursed in accordance with the Settlement Allocation Agreement, entered into on December 9, 2021, which provided that the settlement payments, including the cost of the forensic expert, would first be made by the Company and then reimbursed by Biofrontera AG for its share.

 

24.22. Retirement Plan

 

The Company has a defined-contribution plan under Section 401(k) of Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salarysalary..

 

For the three months ended March 31, 20222023 and 2021,2022, matching contribution costs paid by the Company were $64,0000.1 and $61,000, respectively.million.

 

25.23. Subsequent Events

 

We have completed an evaluation of subsequent events after the balance sheet date of March 31, 20222023 through the date this Quarterly Report on Form 10-Q was submitted to the SEC. We have concluded that no subsequent events have occurred that require recognition

Settlement Agreement

On April 11, 2023, Biofrontera Inc. and each member of its Board of Directors, in their individual capacities, entered into a settlement agreement (the “Settlement Agreement”) with Biofrontera AG, a significant stockholder of the Company.

Pursuant to the terms of the Settlement Agreement, the major provisions are as follows:

the Company and a member of its Board of Directors withdrew their challenges to the resolutions passed at the Biofrontera AG stockholder meeting on January 9, 2023
the Company will increase the Board of Directors from five to six members and appoint as a Class I Director a director nominated by Biofrontera AG to fill the vacancy, subject to certain restrictions as described in the Settlement Agreement;
the Company will begin a search for an additional director candidate, who is fully independent, to be nominated for election as a Class II Director at the Company’s 2023 annual meeting of stockholders; at which point the Company will increase the size of the Board of Directors to seven members;
the Board established a Related Party Transactions Committee to approve all contracts and transactions between the Company and Biofrontera AG, including any of its affiliates;
the Company amended on April 26, 2023 that certain Stockholder Rights Agreement dated October 13, 2022, between the Company and Computershare Trust Company, N.A., as Rights Agent to increase the threshold of beneficial ownership before being deemed an Acquiring Person, solely with respect to Biofrontera AG, from 20% to 29.96%.

Loan and Security Agreement

On May 8, 2023, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap Business Credit LLC, providing us with a revolving line of credit in the financial statements or disclosureaggregate principal amount of up to $6.5 million, subject to a borrowing base. The Loan Agreement allows the Company to request advances thereunder and to use the proceeds of such advances for working capital purposes until the maturity date of May 8, 2026. The Loan Agreement is secured by a lien on substantially all of the assets of the Company, subject to customary exceptions.

Advances under the Loan Agreement shall bear interest at the 30-Day Adjusted Term SOFR Rate, set monthly on the first day of the month based on 30-Day Term SOFR plus a spread adjustment of 15 basis points and subject to a floor of 2.25%, plus 4.00% calculated and charged monthly in arrears. In the event of a called event of default, a default interest rate of 3.00% percent shall be added to the aforementioned rate. Under the terms of the Loan Agreement, amounts available for advances would be subject to a borrowing base, which is a formula based on certain eligible receivables and inventory. The Loan Agreement also includes an Unused Line Fee Rate of 0.375% of the Credit Limit less all outstanding advances, which shall be paid on a monthly basis. Currently, our borrowing capacity is limited to our eligible receivables, pending consent from Biofrontera AG to allow Midcap to obtain title to Biofrontera Inc.’s inventory in the notes to the financial statements. 

event of bankruptcy.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Forward-Looking Statements

 

The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain statements in this Form 10-Q constitute “forward-looking statements”. Such statements include estimates of our expenses, future revenue, capital requirements, our need for additional financing, statements regarding the efficacy and intended use of our technologies under development, the timelines and strategy for bringing such licensed products to market, the timeline for regulatory review and approval of our licensed products, and other statements that are not historical facts, including statements which may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guaranties of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from the expectations contained in the forward-looking statements.

 

Factors that may cause such differences 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 Biofrontera Pharma, Biofrontera Bioscience and Ferrer Internacional S.A. (“Ferrer”), referred to collectively as our (“licensors”) to establish and maintain relationships with contract manufacturers that are able to supply us with enough of the licensed products to meet our demand;
   
 the ability of our licensors or our licensors’ manufacturing partners, as applicable, to supply Ameluz®, BF-RhodoLED® lamps, Xepi® or other 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 effect of the COVID-19 global pandemic, including mitigation efforts and economic effects;
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;
   
 our success in achieving profitability;
   
 our ability to obtain additional financing as needed to implement our growth strategy.strategy;
   
 our success in remediating material weaknesses in our internal control over financial reportingthe effect of the COVID-19 global pandemic, including mitigation efforts and in establishing adequate internal controls over financial reporting;economic effects;
   
 our ability to retain and recruit key personnel;
   
 our success in making the transition to operate as a public company;
such other risks identified in Item 1A. Risk Factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 20212022 and any other filings with the SEC.

 

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More detailed information about us and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this Quarterly Report on Form 10-Q, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2021.2022. We urge investors and security holders to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

 

Overview

 

We areBiofrontera Inc (the “Company”). is a U.S.-based biopharmaceutical company specializing in the commercializationcommercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions in particular, diseases caused primarily by exposure to sunlight that result in sun damage to the skin. Our principalwith a focus on photodynamic therapy (“PDT”) and topical antibiotics. The Company’s licensed product focuses onproducts are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions that can sometimes lead to skin cancer. We also market a topical antibiotic for treatment ofas well as impetigo, a bacterial skin infection.

 

Biofrontera Inc. includes its wholly owned subsidiary Bio-FRI GmbH, a limited liability company organized under the laws of Germany. Our subsidiary, Bioi-FRI was formed on February 9, 2022, as a German presence to facilitate our relationship with the Ameluz Licensor.

Our principal licensed product is Ameluz®Ameluz®, which is a prescription drug approved for use in combination with our licensor’s FDA-approved medical devices, the BF-RhodoLED® RhodoLED® lamp series, consisting of the BF-RhodoLED® and the RhodoLED® XL lamps, for photodynamic therapy inPDT (when used together, “Ameluz® PDT”). In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment of actinic keratoses (“AK”) of mild-to-moderate severity on the face and scalp. AKs are premalignant lesions of the skin that can potentially develop into skin cancer (squamous cell carcinoma) if left untreated.1 International treatment guidelines list photodynamic therapy as the “gold standard” for treating AK, especially multiple AKs and the surrounding photodamaged skin.2We are currently selling Ameluz®Ameluz® for this indication in the U.S. under an exclusive license and supply agreement (“Ameluz LSA”), by between Biofrontera, Inc. and among us and Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH (collectively, the (“Ameluz Licensor”) originally dated as of October 1, 2016, and as subsequently amended on October 8, 2021. Under the Ameluz LSA, we hold the exclusive license to sell Ameluz® and the BF-RhodoLED® lamp in the United States for all indications currently approved by the FDA as well as all future FDA-approved indications that the Ameluz Licensor may pursue. We are obliged to purchase Ameluz® and the RhodoLED® devices exclusively from the Licensor. Under the Ameluz LSA, the Licensor is obliged to manufacture, perform regulatory work and sponsor certain clinical trials on its own expense. In consideration, we are obligated to pay a transfer price of 30-50% of our net sales of Ameluz®. We have the authority under the Ameluz LSA in certain circumstances to i) take over clinical development with respect to the indications the Ameluz Licensor is currently pursuing with the FDA (as well as certain other clinical studies identified in the Ameluz LSA), ii) take over the regulatory and manufacturing responsibilities from the Ameluz Licensor, and iii) to offset the costs of such operations by adjusting the transfer price for Ameluz® or to reduce the transfer price at a fixed ratio. The Ameluz Licensor does not have any obligation under the Ameluz LSA, as amended, to perform or finance clinical trials to promote new indications beyond those they are currently pursuing with the FDA (as well as certain other clinical studies identified in the Ameluz LSA). Under the Ameluz LSA, further extensions of the approved indications for Ameluz® photodynamic therapy in the United States are anticipated.Licensors.

 

Our second prescription drug licensed product in our portfolio is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi® is known and it has been specifically approved by the FDA for the treatment of impetigo, a common skin infection, due to Staphylococcus aureus or Streptococcus pyogenes. It is approved for use in the United States in adults and children 2 months and older. We are currently selling Xepi® for this indication in the U.S.United States. under an exclusive license and supply agreement, as amended (“Xepi LSA”) with Ferrer Internacional S.A. (“Ferrer”) that was acquiredassumed by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc.(“Cutanea”).

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Our principal objective is to increase the sales of our licensed products in the United States. The key elements of our strategy include the following:

 

expanding our sales in the United States of Ameluz® in combination with the RhodoLEDBF-RhodoLED® lamp for the treatment of minimally to moderately thick actinic keratoses of the face and scalp and positioning Ameluz® to be a leading photodynamic therapy product,the standard of care in the United States by growing our dedicated sales and marketing infrastructure in the United States;
  
expanding our sales of Xepi®for treatment of impetigo by improving the market positioning of the licensed product; and
  
leveraging the potential for future approvals and label extensions of our portfolio products that are in the pipeline for the U.S. market through the LSAs with our Licensors.

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Our strategic objectives also include further expansion of our product and business portfolio through various methods to pursue selective strategic investment and acquisition opportunities to expand and support our business growth, including but not limited to:

in-licensing further products or product opportunities and developing them for the U.S. market;
procuring products through asset acquisition from other healthcare companies;Licensors; and
  
procuringopportunistically adding complementary products through share acquisition of some or all shares of other healthcare companies, including the possible acquisition of shares ofservices to our former parent companyportfolio by acquiring or licensing IP to further leverage our commercial infrastructure and significant stockholder, Biofrontera AG.customer relationships.

 

We devote a substantial portion of our cash resources to the commercialization of our licensed products, Ameluz®, and the RhodoLEDBF-RhodoLED® lamp series and Xepi®.series. We have financed our operating and capital expenditures through cash proceeds generated from our product sales and proceeds received in equity financings.

 

We believe that important measures of our results of operations include product revenue, operating income (loss) and adjusted EBITDA (a non-GAAPnon-U.S. GAAP measure as defined below). Our sole source of product revenue is sales of products that we license from certain related and unrelated companies. Our long-term financial objectives include consistent revenue growth and expanding operating margins. Accordingly, we are focused on licensed product sales expansion to drive revenue growth and improve operating efficiencies, including effective resource utilization, information technology leverage, and overhead cost management.

 

Key factors affecting our performance

 

As a result of a number of factors, our historical results of operations may not be comparable to our results of operations in future periods, and our results of operations may not be directly comparable from period to period. Set forth below is a brief discussion of the key factors impacting our results of operations.

 

Seasonality

 

Because traditional photodynamic therapy treatments using a lamp are performed more frequently during the winter, our revenue is subject to some seasonality and has historically been higher during the first and fourth quarters than during the second and third quarters.

 

COVID-19

 

Since the beginning of 2020,The COVID-19 has become a global pandemic. Aspandemic still affects our business and presents challenges. However, we are optimistic that our business will continue to thrive throughout 2023 as a result of the measures implemented by governments aroundCOVID-19 Public Health Emergency (PHE) sunsetting on May 11, 2023. However, the world, our business operations have been directly affected. In particular, we experienced a significant decline in demand for our licensed products as a result of different priorities for medical treatments emerging, thereby causing a delay of actinic keratosis treatment for most patients. Our revenue was directly affected by the global COVID-19 pandemic starting in mid-March of 2020. From that point on, rising infection rates and the resulting American Academy of Dermatology’s official recommendation to care for patients through remote diagnosis and treatment (telehealth) led to significantly declining patient numbers and widespread, albeit temporary, physician practice closures. As COVID-19 vaccines started to roll-out to the general public in March 2021, we experienced an increase in patients willing to undergo treatment for actinic keratosis. In the fourth quarter of 2021 continuing through the first quarter of 2022, we again saw a seasonally strong increase in sales, indicating a revenue recovery from the global COVID-19 pandemic. However, due to the speed and fluidity with which the COVID-19 pandemic continues to evolve, and the emergence of highly contagious variants, we do not yet know the full extent of the impact of COVID-19 on our business operations. The ultimate extent of the impact of any epidemic, pandemic, outbreak, or other public health crisis on our business, financial condition and results of operations will depend on future developments, which are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity of such epidemic, pandemic, outbreak, or other public health crisis and actions taken to contain or prevent the further spread, including the effectiveness of vaccination and booster vaccination campaigns, among others. Accordingly, we cannot predict the extent to which our business, financial condition and results of operations will continue to be affected. We remain focused on maintaining a strong balance sheet, liquidity and financial flexibility and continue to monitor developments as we deal with the disruptions and uncertainties from a business and financial perspective relating to COVID-19 and variants thereof.

 

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Supply Chain

 

While our Licensors take reasonable precautions to ensure the successful production of our commercially licensed products, their contract manufacturers may experience a myriad of business difficulties (i.e., workforce instability, supply chain issues, erosion of customer base, etc.) that could impact their financial solvency. In December 2021, we were notified by Ferrer of third-party manufacturing delays for the Xepi® product and of their manufacturer’s (Teligent, Inc.) Chapter 11 bankruptcy filing on October 14, 2021 and in February 2022, Teligent Inc. filed a motion to convert the proceedings into a Chapter 7 liquidation. As Teligent, Inc, is no longer a viable manufacturing option, Ferrer is evaluating options for a new contract manufacturer for Xepi®, but the process of engaging one or more new contract manufacturers to replace Teligent, Inc. will require significant time, including the time it will take the new contract manufacturer(s) to reach a level of production to meet our commercial needs.product. Although we have inventory of Xepi® on hand, we do not expect it will be enough to complete the commercialization of Xepi® in accordance with the originally planned timeline. Due to the uncertainty of supply chain, we expect a delay in further shipments of Xepi® for the next 188 to 12 months however, the Company expects Ferrer to perform its obligations under the Xepi LSA to use its commercially reasonable efforts to qualify an alternative supplier during this period of time.. Despite these delays, our total revenues will not be significantly impacted since the majority of our revenues are from sales of Ameluz®. After adjusting our forecast due to supply chain issues, we expect our net Xepi revenues impact to be $0.5 million over the next twelve months. We continue to monitor the impacts of the supply chain on our business and are focused on ensuring the stability of the supply chains for Ameluz® and RhodoLEDBF-RhodoLED®.

 

Components of Our Results of Operations

 

Product Revenue, net

 

We generate product revenues through the third-party sales of our licensed products Ameluz®, RhodoLEDBF-RhodoLED® lamps and Xepi®. Revenues from product sales are recorded net of discounts, rebates and other incentives, including trade discounts and allowances, product returns, government rebates, and other incentives such as patient co-pay assistance. Revenue from the sales of our RhodoLEDBF-RhodoLED® lamp and Xepi®are relatively insignificant compared with revenues generated through our sales of Ameluz®.

 

The primary factors that determine our revenue derived from our licensed products are:

 

the level of orders generated by our sales force;
  
the level of prescriptions and institutional demand for our licensed products; and
  
unit sales prices.

 

Related Party Revenues

 

We also generate insignificant related party revenue in connection with an agreement with Biofrontera Bioscience to provide RhodoLED® lamps and associated services for the clinical trials performed by Biofrontera Bioscience.

 

Cost of Revenues, Related Party

 

Cost of revenues, related party, is comprised of purchase costs of our licensed products, Ameluz® and RhodoLEDBF-RhodoLED® lamps from Biofrontera Pharma GmbH.GmbH and insignificant inventory adjustments due to scrapped, expiring and excess products.

On October 8, 2021, we entered into an amendment to the Ameluz LSA under which the price we pay per unit will be based upon our sales history. As a result of this amendment, the purchase price we pay the Ameluz Licensor for Ameluz® will be determined in the following manner:

fifty percent of the anticipated net price per unit until we generate $30 million in revenue from sales of the products we license from the Ameluz Licensor during a given Commercial Year (as defined in the Ameluz LSA);
forty percent of the anticipated net price per unit for all revenues we generate between $30 million and $50 million from sales of the products we license from the Ameluz Licensor; and
thirty percent of the anticipated net price per unit for all revenues we generate above $50 million from sales of the products we license from the Ameluz Licensor.

 

Cost of Revenues, Other

 

Cost of revenues, other, is comprised of purchase costs of our licensed product, Xepi®, third-party logistics and distribution costs including packaging, freight, transportation, shipping and handling costs, inventory adjustment due to expiring Xepi® products, as well as sales-based Xepi® royalties.

 

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Selling, General and Administrative Expense

 

Selling, general and administrative expenses consist principally of costs associated with our sales force, commercial support personnel, personnel in executive and other administrative functions, as well as medical affairs professionals. Other selling, general and administrative expenses include marketing, trade, and other commercial costs necessary to support the commercial operation of our licensed products and professional fees for legal, consulting and accounting services. Selling, general and administrative expenses also include the amortization of our intangible asset and our legal settlement expenses.

 

Selling, General and Administrative Expenses, Related Party

 

Selling, general and administrative expenses, related party, primarily relate to the services provided by our significant stockholder, Biofrontera AG, for accounting consolidation, IT support, and pharmacovigilance. These expenses were previously charged to us based on costs incurred plus 6% in accordance with the 2016 Services Agreement. As ofIn December 31, 2021, we entered into thean Amended and Restated Master Contract Services Agreement, or “Services Agreement”, which provides for the execution of statements of work that supersedessupersede the applicable provisions of the 2016 Services Agreement. The Services Agreement enables us to continue relying on Biofrontera AG and its subsidiaries for various services it has historically provided to us, including IT and pharmacovigilance support.support for as long as we deem necessary. We currently have statements of work in place regarding IT, regulatory affairs, medical affairs, pharmacovigilance, and Investor Relations services, and are continuously assessing the other services historically provided to us by Biofrontera AG to determine 1) if they will be needed, and 2) whether they can or should be obtained from other third-party providers.

Restructuring Costs

We restructured the business As of Cutanea and incurred restructuring costs, which were subsequently reimbursed by Maruho. Restructuring costs primarily relateMarch 31, 2023, we have migrated most of our significant IT services from Biofrontera AG to Aktipak® discontinuation, personnel costs related to the termination of all Cutanea employees, and the winding down of Cutanea’s operations.third party providers.

 

Change in Fair Value of Contingent Consideration

 

In connection with the Cutanea acquisition, we recorded contingent consideration related to the estimated profits from the sale of Cutanea products to be shared equally with Maruho. The fair value of such contingent consideration was determined to be $6.5 million on the acquisition date of March 25, 2019 and is re-measured at each reporting date, with changes in fair value presented in the consolidated statement of operations, until the contingency is resolved.

 

Change in Fair Value of Warrant Liabilities

Common stock warrants to purchase up to 2,857,143 shares of our common stock at an exercise price of $5.25 per share were issued in conjunction with the private placement which closed on December 2, 2021 and werefinancing transactions are accounted for as liabilities in accordance with ASC 815-40.

The warrant liability is measured at fair value at inception and on a recurring basis, with changes in fair value presented within the consolidated statements of operations.

 

Change in Fair Value of Investment in Equity Securities

Our investments are comprised of equity securities in shares of Biofrontera AG, which are initially recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and losses reported in the Company’s consolidated statement of operations. For the investments held in foreign currencies, the change in fair value attributable to changes in foreign exchange rates is included in gains and losses in the consolidated statement of operations.

The Company may sell its equity securities in response to changes in interest rates, risk/reward characteristics, liquidity needs or other factors.

Interest Expense, net

 

Interest expense, net, primarily consists of amortization of the contract asset related to the start-up cost financing from Maruho Co. Ltd’s. (“Maruho”) agreement (“under the Share Purchase and Transfer Agreement dated March 25, 2019 (as amended, the “Share Purchase Agreement”) to acquire 100% of the Shares of Cutanea Life Sciences, Inc. (“Cutanea”), offset by interest income of 6% per annum for each day that any reimbursement is past due related to the Amended Settlement Allocation Agreement with Biofrontera AG, and immaterial amounts of interest income earned on our financing of customer purchases of RhodoLEDBF-RhodoLED® lamps.

 

24
 

 

Other Income (Expense), net

 

Other income (expense), net primarily includes (i) reimbursed Share Purchase Agreement costs,gain (loss) on sale of leased assets and (ii) gain (loss) on foreign currency transactions.

 

Income Taxes

 

As a result of the net losses, we have incurred in each fiscal year since inception, we have recorded no provision for federal income taxes during such periods. Income tax expense incurred relates to state income taxes.

 

Results of Operations

 

Comparison of the Three Months ended March 31, 20222023 and 20212022

 

The following table summarizes our results of operations for the three months ended March 31, 20222023 and 2021:2022:

 

(in thousands) 2022 2021 Change  2023  2022  Change 
              
Product revenues, net $9,736  $4,731  $5,005  $8,715  $9,736  $(1,021)
Related party revenues  15   13   2   18   15   3 
Revenues, net  9,751  $4,744   5,007   8,733  $9,751   (1,018)
                        
Operating expenses:                        
Cost of revenues, related party  4,975   2,408   2,567   4,547   4,975   (428)
Cost of revenues, other  175   163   12   51   175   (124)
Selling, general and administrative  7,616   4,758   2,858   9,800   7,616   2,184 
Selling, general and administrative, related party  95   164   (69)  27   95   (68)
Restructuring costs  -   281   (281)
Change in fair value of contingent consideration  -   498   (498)  (200)  -   (200)
Total operating expenses  12,861   8,272   4,589   14,225   12,861   1,364 
Loss from operations  (3,110)  (3,528)  418   (5,492)  (3,110)  (2,382)
Change in fair value of warrant liabilities  8,711   -   8,711   1,028   8,711   (7,683)
Change in fair value of investments  (2,941)  -   (2,941)
Interest expense, net  (33)  (84)  51   (35)  (33)  (2)
Other income, net  23   79   (56)
Other income (expense), net  (33)  23   (56)
Loss before income taxes  5,591   (3,533)  9,124   (7,473)  5,591   (13,064)
Income tax expenses  30   1   29   5   30   (25)
Net loss $5,561  $(3,534) $9,095 
Net income (loss) $(7,478) $5,561  $(13,039)

 

Product Revenue, net

 

Net product revenue was $9.8$8.7 million and $4.7$9.8 million for the first three months ended March 31, 2023 and 2022, respectively, a decrease of 2022 and 2021, respectively, an increase of $5.0$1.02 million, or 105.5%. The increase was primarily10.5%, This decrease is driven by thea higher volume of Ameluz® orders, which resulted revenue in anQ1 2022 caused by customer buy-in prior to a price increase on April 1, 2022. Unlike 2022, the Company did not increase the price of Ameluz in Ameluz® revenue of $4.6 million, which was coupled with the impact of2023, and therefore did not see a similar buy-in effect from customers anticipating a price related to Ameluz® of $0.4 million.increase.

 

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Operating Expenses

Cost of Revenues, Related Party

Cost of revenues, related party was $5.0$4.5 million and $2.4$5.0 million for the first three months ended March 31, 2023 and 2022, respectively, a decrease of 2022 and 2021, respectively, an increase of $2.6$0.4 million, or 106.6%.8.6%, which was driven by the increasedecrease in Ameluz® product revenue. Cost of revenues, related party, is directly correlated to the selling price of Ameluz under the Ameluz LSA.

Cost of Revenues, Other

Cost of revenues, other was consistent at $0.2 million for both the first three months of 2022 and 2021

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were $7.6$9.8 million and $4.8$7.6 million for the first three months ofended March 31, 2023 and 2022, and 2021, respectively, an increase of $2.9$2.2 million, or 60.0%28.7%.

The increase was primarily driven by legal expenses$1.2 million of $0.5 million and business insurance of $0.5 million. Headcount costs also increased $0.4 million as a result of (i) resumed hiringpersonnel cost due to increased headcount primarily in 2022 and (ii) higher commission expenses related to improvedthe sales performance. The increase was further driven by stock compensation expense of $0.5 million, resumed travel of $0.3 millionteam as well as higher year over year consulting$1.0 million of increased legal expenses of $0.2 million.

Selling, General and Administrative Expenses, Related Party

Selling, general and administrative expenses, related party were $0.1 million and $0.2 million for the first three months of 2022 and 2021, respectively,resulting primarily from a decrease of $0.1 million or -42.1%. Related party expense is based on statements of work issued under the Services Agreement with the Biofrontera Group. We currently have statements of work in place regarding IT, regulatory affairs, medical affairs, pharmacovigilance, and Investor Relations services. Prior period related party expense was based on costs incurred by Biofrontera AG plus 6% for services provided to us related to accounting consolidation, IT support and pharmacovigilance. Decrease of $0.1 million is mainly related to IT development and quality assurance services. Biofrontera AG provides IT development application services as well as any network issues and hosts Biofrontera, Inc.’s servers.

Restructuring Costs

Restructuring costs were $0.0 million and $0.3 million for 2022 and 2021, respectively, a decrease of $0.3 million, or 100%, which was related to facility exit costs.legal settlement.

 

Change in Fair Value of Contingent Consideration

 

The change in fair value of contingent consideration was $0 million and $0.5a decrease of $0.2 million for the first three months of 2022 and 2021, respectively, a decrease of $0.5 million or -100.0%.ended March 31, 2023 compared to the three months ended March 31, 2022. The change in fair value of contingent consideration is driven by the estimated profit share the Company is required to pay under the Share Purchase Agreement.

 

Change in Fair Value of Warrant Liabilities

 

The change in fair value of warrant liabilities was a decrease of $8.7$7.7 million for 2022.three months ended March 31, 2023. The change in fair value of warrant liabilities was driven by changes in the underlying value of the common stock. There were no warrant liabilities as of March 31, 2021.

Interest Expense, net

Interest expense, net was $33 thousand and $0.1 million for the first three months of 2022 and 2021, respectively. The slight decrease in interest expense was mainly driven by legal settlement interest income in 2022. Interest expense from the straight-line amortization of the contract asset related to start-up cost financing received from Maruho under the Cutanea acquisition purchase agreement was $0.1 million during both periods.

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Other Income, netChange in fair value of investments in equity securities

 

Other income, netThe change in fair value of investments in equity securities was $23 thousand and $79 thousand in the first three months of 2022 and 2021, respectively, a decrease of $56 thousand or -70.9%. Decrease is primarily related to$2.9 million, driven by changes in the decrease in reimbursed costs underquoted market price of the Share Purchase Agreement with Maruho.common stock of Biofrontera AG.

 

Net Income (Loss) to Adjusted EBITDA Reconciliation for the Three Months Ended March 31, 20222023 and 20212022

 

We define adjusted EBITDA as net income or loss before interest income and expense, income taxes, depreciation and amortization, and other non-operating items from our consolidated statements of operations as well as certain other items considered outside the normal course of our operations specifically described below. Adjusted EBITDA is not a presentation made in accordance with GAAP.U.S. generally accepted accounting principles (“U.S. GAAP”). Our definition of adjusted EBITDA may vary from the use of similarly-titled measures by others in our industry due to the potential inconsistencies in the method of calculation and differences due to items subject to interpretation. Adjusted EBITDA should not be considered as an alternative to net income or loss, operating income/(loss), cash flows from operating activities or any other performance measures derived in accordance with U.S. GAAP as measures of operating performance or liquidity. Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our results as reported under U.S. GAAP.

 

Change in fair value of contingent consideration: Pursuant to the Share Purchase Agreement, the profits from the sale of Cutanea products will be shared equally between Maruho and Biofrontera until 2030. The fair value of the contingent consideration was determined to be $6.5 million on the acquisition date and is re-measured at each reporting date.date, with changes in fair value presented within the consolidated statements of operations. We exclude the impact of the change in fair value of contingent consideration as this is non-cash.

 

Change in fair value of warrant liabilities: The Purchase and Pre-funded Warrants issued in conjunction with aour private placement equity financingofferings were accounted for as liabilities in accordance with ASC 815-40. The warrant liabilities wereare measured at fair value at inception and are remeasured at each reporting date,on a recurring basis, with changes in fair value presented within the statementconsolidated statements of operations. We exclude the impact of the change in fair value of warrant liabilities as this is non-cash.

 

Change in fair value of investment in equity securities: The Company accounts for its investments in equity securities in accordance with ASC 321, Investments — Equity Securities (“ASC 321”). Equity securities, which are comprised of investments in common stock, are initially recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and losses reported in the Company’s consolidated statement of operations. For the investments held in foreign currencies, the change in fair value attributable to changes in foreign exchange rates is included in gains and losses in the consolidated statements of operations. We exclude the impact of the change in fair value of investments as this is non-cash. 

Legal settlement expenses: To measure operating performance, we exclude legal settlement expenses. We do not expect to incur these types of legal expenses on a recurring basis and believe the exclusion of such amounts allows management and the users of the financial statements to better understand our financial results.

Stock Based Compensation: To measure operating performance, we exclude the impact of costs relating to share-based compensation. Due to the subjective assumptions and a variety of award types, we believe that the exclusion of share-based compensation expense, which is typically non-cash, allows for more meaningful comparisons of our operating results to peer companies. Share-based compensation expense can vary significantly based on the timing, size and nature of awards granted.

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Adjusted EBITDA margin is adjusted EBITDA for a particular period expressed as a percentage of revenues for that period.

 

We use adjusted EBITDA to measure our performance from period to period and to compare our results to those of our competitors. In addition to adjusted EBITDA being a significant measure of performance for management purposes, we also believe that this presentation provides useful information to investors regarding financial and business trends related to our results of operations and that when non-GAAPnon-U.S. GAAP financial information is viewed with U.S. GAAP financial information, investors are provided with a more meaningful understanding of our ongoing operating performance.

 

The below table presents a reconciliation from net income (loss) to Adjusted EBITDA for the three months ended March 31, 20222023 and 2021:2022:

 

 Three Months Ended March 31,  Three Months Ended March 31, 
 2022  2021  2023  2022 
Net income/(loss) $5,561  $(3,534)
Net income (loss) $(7,478) $5,561 
Interest expense, net  33   84   35   33 
Income tax expenses  30   1   5   30 
Depreciation and amortization  131   138   266   131 
EBITDA  5,755   (3,311)  (7,172)  5,755 
                
Change in fair value of contingent consideration  -   498   (200)  - 
Change in fair value of warrant liabilities  (8,711)  -   (1,028)  (8,711)
Change in fair value of investments  2,941   - 
Legal settlement expenses  1,118   - 
Stock based compensation  351   517 
Adjusted EBITDA $(2,956) $(2,813) $(3,990) $(2,439)
Adjusted EBITDA margin  -30.3%  -59.3%  -45.7%  -25.0%

 

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Adjusted EBITDA

 

Adjusted EBITDA decreased from ($2.8)2.4) million during the three months ended March 31, 2022 to ($4.0) million for the first three months of 2021 to ($3.0) million for the first three months of 2022.ended March 31, 2023 driven by an increase in personnel costs and lower revenues. Our adjusted EBITDA margin improveddecreased from (25%) to (30.3%(45.7%) forduring the first three months of 2022 from (59.3%) for the first three months of 2021.same periods.

 

Liquidity and Capital Resources

The Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, and cash flows from equity financing transactions received in 2021.2022. As of March 31, 2022,2023, we had cash and cash equivalents of $22.4$13.5 million, compared to $24.5$17.2 million as of December 31, 2021.2022.

 

Since we commenced operations in 2015, we have generated significant losses. For the three months ended March 31, 20222023 and 2021,2022, we incurred lossesloss from operations of $5.5 million and $3.1 million, and $3.5 million, respectively. respectively. We incurred net cash outflows from operations of $2.1$3.7 million and $3.4$2.1 million, for the same periods, respectively. We had an accumulated deficit as of March 31, 20222023 of $73.3$87.0 million.

 

The Company’s short-term material cash requirements include working capital needs and satisfaction of contractual commitments including facility and auto leases (see Note 23,21, Commitments and Contingencies), Maruho start-up paymentscost financing repayments of $7.3 million (see Note 3. Acquisition Contract Liabilities), and legal settlement expenses after reimbursement from Biofrontera AG a significant shareholder and former parent company, of $5.6 million (see Note 13. Accrued Expenses and Other Current Liabilities).$2.5 million. Long-term material cash requirements include potential milestone payments to Ferrer Internacional S.A, (See Note 23. Commitments and Contingencies) and contingent consideration payments to Maruho (seeconnected with Xepi sales (See Note 3. Acquisition Contract Liabilities)21. Commitments and Contingencies).

 

Additionally, we expect to continue to incur operating losses due to significant discretionary sales and marketing, medical affairs, and dermatology community outreach efforts as we seek to expand the commercialization of Ameluz® and Xepi®our licensed products in the United States. We also expect to incur additional expenses to add and improve operational, financial and information systems and personnel, including personnel to support our product commercialization efforts. In addition, we expect to incur significant costs to continue to comply with corporate governance, internal controlsregulatory reporting and similarother requirements applicable to us as a public company in the U.S. We expect capital expenditures to increase in 2022 to support the increase in our business needs including an ERP system.

 

These factors raise doubt about our ability to continue as a going concern, which we have determined are mitigated by the following plans. Based on current operating plans and financial forecasts, we expect that our revolving line of credit and expected proceeds from the sale of our investment in Biofrontera AG in addition to our current cash and cash equivalents will be sufficient to fund our operations for at least the next twelve months from the date of issuance of our financial statements. However, we expect to have to obtain either equity or additional debt financing to support our future long-term growth and to mitigate the risk of our operating costs significantly exceeding the amounts currently estimated. If our current operating plans or financial forecasts change, or we are unable to obtain additional financing or the proceeds from the sale of our holdings in Biofrontera AG is lower than expected or we are not able to complete the sale within our planned timeline, we may need to reduce the discretionary spend on promotional expenses, branding, marketing consulting and defer some hiring. While we expect to continue being flexible in our spending over the next twelve months, we do not consider there to be a need to significantly revise our operations currently.

The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including the amounts of future revenues generated by our products. Due to numerous factors described in more detail under the caption Part I, Item 1A, “Risk Factors” of this Form 10-K and our contractual obligations and commitments, we may require significant additional funds earlier than we currently expect in order to continue to commercialize Ameluz®, BF-RhodoLED® lamp series, and Xepi® and to support the operating, investing, and financing activities of the Company beyond the next twelve months.

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Our future use of operating cash and capital requirements will depend on many forward-looking factors, including the following:

 

the costs of our commercialization activities for Ameluz® and Xepi®;
the extent to which we acquire or invest in licensed products, businesses and technologies;
  
the extent to which we choose to establish collaboration, co-promotion, distribution or other similar agreements for our licensed products;
  
the cost to fulfill our contractual obligations for various operating leases on vehicles and office space; and
  
the requirement to pay back $7.3 million of start-up cost financing to Maruho and make any contingent profit- sharing payments to Maruho in connection with the Cutanea acquisition.acquisition; and 
  
the ability to collect a receivable of $11.3$3.7 million from Biofrontera AG (in accordance with the Settlement Allocation Agreement) for reimbursement of legal settlement payments made and to be made on their behalf for which both parties are jointly and severally liable.

 

We will continue to assess our operating costs and expenses and our cash and cash equivalents and, if circumstances warrant, we will make appropriate adjustments to our operating plan.

 

Cash Flows

 

The following table summarizes our cash provided by and (used in) operating, investing and financing activities:

 

 Three Months Ended March 31,  

Three Months Ended

March 31,

 
(in thousands) 2022  2021  2023  2022 
Net cash used in operating activities $(2,112) $(3,443) $(3,689) $(2,112)
Net cash provided by (used in) investing activities  (5)  - 
Net cash used in investing activities  (14)  (5)
Net decrease in cash and restricted cash $(2,117) $(3,443) $(3,703) $(2,117)

 

Operating Activities

 

During the first three months ended March 31, 2023, operating activities used $3.7 million of cash, primarily resulting from our loss from operations of $5.5 million, adjusted for non-cash expense of stock-based compensation of $0.4 million, non-cash interest expense of $0.1 million, and depreciation and amortization in the aggregate of $0.3 million, and net cash used by changes in our operating assets and liabilities of $1.4 million, offset by change in fair value of contingent consideration of $0.2 million.

During the three months ended March 31, 2022, operating activities used $2.1 million of cash, primarily resulting from our loss from operations of $3.1 million, adjusted for non-cash expense of stock-based compensation of $0.5 million, non-cash interest expense of $0.1 million, and depreciation and amortization in the aggregate of $0.1 million and net cash used by changes in our operating assets and liabilities of $0.3 million.

During the three months ended March 31, 2021, operating activities used $3.4 million of cash, primarily resulting from our net loss of $3.5 million, adjusted for non-cash expense of $0.8 million as an offset and net cash used by changes in our operating assets and liabilities of $0.7 million.

 

Investing Activities

 

During the first three months ended March 31, 2023 net cash used in investing activities consisted of the purchase of machinery & computer equipment.

During the three months ended March 31, 2022, net cash used in investing activities in the amount of $5,000 consisted of the purchase of computer equipment.

 

Financing Activities

 

During the first three months 2022ended March 31, 2023 and 2021,2022, there was no net cash provided by or used in financing activities.

 

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Accounting Policies and Significant Judgments and Estimates

 

Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles of the United States, or U.S. GAAP. The preparation of the financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions by management that affect the value of assets and liabilities, as well as contingent assets and liabilities, as reported on the balance sheet date, and revenues and expenses arising during the reporting period. The main areas in which assumptions, estimates and the exercising of a degree of judgment are appropriate relate to fair value measurements of contingent consideration, and warrant liabilities, and stock compensation. Estimates are based on historical experience and other assumptions that are considered appropriate in the circumstances. They are continuously reviewed but may vary from the actual values.

 

Our significant accounting policies are described in more detail in Note 2 – Summary of Significant Accounting Policies, to our consolidated financial statements included inItem 8, “Financial Statements and Supplementary Data,” our Annual Report on Form 10-K.

 

Critical Accounting Estimates

 

A summary of our critical accounting estimates is included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.2022. There were no material changes to our critical accounting estimates for the three months ended March 31, 2022.2023.

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Off-balance Sheet Arrangements

 

Besides the contractual obligations and commitments as discussed in the section titled Liquidity and Capital Resources, we did not have during the periods presented, and we do not currently have, any other off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

 

Emerging Growth Company Status

 

The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to take advantage of such extended transition period, which means that when an accounting standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

As a “smaller reporting company,” we are not required to provide the information required by this Item.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officerChief Executive Officer and principal financial officer,Chief Financial Officer, evaluated, as of the end of the period covered by this Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, and as a result of the material weakness described below, our Chief Executive Officer and Senior Director FinanceChief Financial Officer concluded that, as of March 31, 2022,2023, our disclosure controls and procedures were not effective at the reasonable assurance level.

Material Weaknesses in Internal Control Over Financial Reporting

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

In connection with the audits of our financial statements as of and for the years ended December 31, 2021 and December 31, 2020, we identified a material weakness in our internal control over financial reporting. The previously identified material weakness pertains to our oversight of work being performed for the Company by third-party service providers; as the Company’s management review control over information produced by third-party service providers was not sufficiently precise to identify errors. Specifically, as part of the valuation of an intangible asset in connection with the acquisition of Cutanea, we failed to identify a computational error within the valuation model for the Xepi® intangible asset. In addition, in 2021 an error in the valuation of the same intangible asset was identified relating to insufficient information being provided to the third-party consultant in connection with an impairment assessment.

Relating to the previously identified deficiency pertaining to management’s review of work performed by specialists, management has implemented measures designed to improve our internal control over financial reporting including formalized reviews of transactions handled by the specialist. However, in light of the prior year control deficiency, the remediation is still considered to be in process. We will monitor the effectiveness of our remediation plan and will continue to make changes we determine to be appropriate. As a result, management has concluded that the material weakness was not fully remediated as of March 31, 2022.

Management will continue its remediation work by adding steps to the engagement of third-party specialists for assistance with complex or judgmental accounting areas, including checks and balances over the proper flow of information to the specialist to allow for an adequate understanding of the transaction.

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As previously noted, we are still in process of remediating this material weakness as of March 31, 2022. If we are unable to remediate this material weakness, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal control, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, our stock price.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting during the most recent fiscal quarter ended March 31, 20222023 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act).

 

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PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

For information regarding legal proceedings in which we are involved, see Note 2321 - Commitments and Contingencies under the subsection titled “Legal Proceedings” in our Notes to Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form 10-Q.

 

Item 1A. Risk Factors

 

As a smaller reporting company, we are not required to provide disclosure pursuant to this item in this Form 10-Q. However, you should carefully consider the “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021,2022, for a discussion of important factors that could materially affect our business, financial condition and/or operating results.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Use of Proceeds from our Initial Public OfferingNone

On October 28, 2021, our registration statement on Form s-1 (File No. 333-257722) relating to the initial public offering (“IPO”) of our common stock became effective.

Proceeds received were used for working capital and general corporate purposes. There has been no material change in the planned use of proceeds from the IPO of our common stock from that described in the Prospectus.   

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not Applicable.

 

Item 5. Other Information

 

NonePursuant to the Commitment Letter with MidCap Business Credit LLC (“MidCap”) previously disclosed in Item 9B of our Annual Report on Form 10-K, on May 8, 2023, we entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap, providing us with a revolving line of credit in the aggregate principal amount of up to $6.5 million, subject to a borrowing base and an availability block. The Loan Agreement allows us to request advances thereunder and to use the proceeds of such advances for working capital purposes until the maturity date of May 8, 2026. The Loan Agreement is secured by a lien on substantially all of the assets of the Company, subject to customary exceptions.

 

Advances under the Loan Agreement shall bear interest at the 30-Day Adjusted Term SOFR Rate, set monthly on the first day of the month based on 30-Day Term SOFR plus a spread adjustment of 15 basis points and subject to a floor of 2.25%, plus 4.00% calculated and charged monthly in arrears. In the event of a called event of default, a default interest rate of 3.00% percent shall be added to the aforementioned rate. Under the terms of the Loan Agreement, amounts available for advances would be subject to a borrowing base, which is a formula based on certain eligible receivables and inventory , and a block on such availability in the amount of $650,000 (the “Availability Block”). The Loan Agreement also includes an Unused Line Fee Rate of 0.375% of the Credit Limit (as defined in the Loan Agreement) less all outstanding advances, which shall be paid on a monthly basis.

The Loan Agreement also provides for the issuance of letters of credit with a $250,000 sublimit. We do not currently have any letters of credit outstanding.

The Loan Agreement includes customary covenants, including limitations on liens, indebtedness, restricted payments and a financial maintenance covenant requiring maintenance of minimum revenue from our licensed product Ameluz® tested on a quarterly basis. In addition, at our election, we may remove the Availability Block by electing to become subject to a minimum EBITDA (as defined in the Loan Agreement) maintenance financial test, to be tested quarterly following such election. The Loan Agreement also contains customary events of default provisions.

The Loan Agreement may be terminated prior to its maturity date, (i) by MidCap as a result of the occurrence of an Event of Default (as defined in the Loan Agreement) or (ii) by us at any time upon thirty days written notice, subject to an early termination fee in certain circumstances. If the Loan Agreement is terminated by the Lender following the occurrence of an Event of Default or if we terminate the Loan Agreement more than sixty days before the third anniversary of the Loan Agreement, we are required to pay an early termination fee of up to $150,000 according to the formula for the early termination fee set forth in the Loan Agreement.

The foregoing description of the Loan Agreement does not purport to be complete and is qualified in its entirety by reference to the Loan Agreement, a copy of which is filed herewith as Exhibit 10.3 and incorporated herein by reference.

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Item 6. Exhibits

 

The following exhibits are filed herewith or are incorporated by reference to exhibits previously filed with the SEC.

 

Exhibit No. 
10.1 
4.1 Amended Settlement AllocationAmendment No. 1 to the Stockholder Rights Agreement, dated March 31,2022as of April 26, 2023, between theBiofrontera Inc. and Computershare Trust Company, and Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, Biofrontera Development GmbH, Biofrontera Neuroscience GmbH,N.A., as Rights Agent (incorporated by reference to Exhibit 10.1 to4.1 of the Company’s Current Report on Form 8-K, filed with the SEC on April 5, 2022)28, 2023).
10.1*#†Settlement Agreement dated April 11, 2023 between Biofrontera Inc., Hermann Luebbert, John J. Borer, Loretta M. Wedge, Beth J. Hoffman, Kevin D. Weber and Biofrontera AG
10.2*Commitment Letter dated as of March 9, 2023 between the Company and MidCap Business Credit LLC.
10.3*#Loan and Security Agreement, dated as of May 8, 2023, between the Company, as Borrower, and MidCap Business Credit LLC, as Lender.
  
31.1*Certification of Principal Executive Officer andpursuant to Section 302 of the Sarbanes Oxley Act of 2002
31.2*Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
  
32.1*Certification of Principal Executive Officer andpursuant to Section 906 of the Sarbanes Oxley Act of 2002
32.2*Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
  
101.INS*Inline XBRL Instance Document
  
101.SCH*Inline XBRL Taxonomy Extension Schema Document
  
101.CAL*Inline XBRL Taxonomy Extension Calculation Linkbase Document
  
101.DEF*Inline XBRL Taxonomy Extension Definition Linkbase Document
  
101.LAB*Inline XBRL Taxonomy Extension Label Linkbase Document
  
101.PRE*Inline XBRL Taxonomy Extension Presentation Linkbase Document
  
104Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101)

 

*Filed herewith.
Certain confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
#The schedules (and similar attachments) to this exhibit have been omitted from this filing pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to furnish a supplemental copy of any omitted schedule (or similar attachment) to the SEC upon request

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized .authorized.

 

 BIOFRONTERA INC.
   
Date: May 13, 202212, 2023By:/s/ Erica L. Monaco
 Name:Erica L. Monaco
 Title:

Chief Executive Officer

(Duly Authorized Officer, Principal Executive Officer)

Date: May 12, 2023By:/s/ E. Fred Leffler
Name:E. Fred Leffler, III
Title:

Chief Financial Officer and

(Principal Financial Officer)Officer)

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